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Tofu is a soft food made from soybean processing. Soybeans are made up of two types of Genetically Modified Organism (GMO) and non-Genetically Modified Organism (non-GMO). Transgenic soybeans are soybeans that undergo genetic changes for a specific purpose. Non-transgenic soybeans that do not undergo genetic changes. The purpose of this study was to analysis of the effect of raw material soybeans on yield, protein content, and water content, amino acid type, and organoleptic properties of tofu. This study uses two types of soybeans to make tofu, namely transgenic soybeans (Lotus USA) and non-GMO (Anjasmoro). Its methods include soybean soaking, soy milk peeling, filtration, heating, coagulation, and squeezing. The results showed the yield and tofu protein of non-transgenic soybeans were higher than transgenic. The non-transgenic soybean water content is lower than transgenic. The taste and aroma of non-transgenic soybeans are superior to that of transgenic soybeans because they are more savory and smell typical of soybeans, for the texture and color of tofu transgenic soybeans are superior to non-transgenic soybeans. Tofu of non-transgenic soybeans has lower levels of the essential amino acids arginine, phenylalanine, and leucine than transgenic. But tofu of non-transgenic soybeans has higher levels of the non-essential amino acid glutamic than transgenic.

Motivation: The availability of databases identifying allergenic proteins via a transparent and consensus-based scientific approach is of prime importance to support the safety review of genetically-modified foods and feeds, and public safety in general. Over recent years, screening for potential new allergens sequences has become more complex due to the exponential increase of genomic sequence information. To address these challenges, an international collaborative scientific group coordinated by the Health and Environmental Sciences Institute (HESI), was tasked to develop a contemporary, adaptable, high-throughput process to build the COMprehensive Protein Allergen REsource (COMPARE) database, a publicly accessible allergen sequence data resource along with bioinformatics analytical tools following guidelines of FAO/WHO and CODEX Alimentarius Commission.Results: The COMPARE process is novel in that it involves the identification of candidate sequences via automated keyword-based sorting algorithm and manual curation of the annotated sequence entries retrieved from public protein sequence databases on a yearly basis; its process is meant for continuous improvement, with updates being transparently documented with each version; as a complementary approach, a yearly key-word based search of literature databases is added to identify new allergen sequences that were not (yet) submitted to protein databases; in addition, comments from the independent peer-review panel are posted on the website to increase transparency of decision making; finally, sequence comparison capabilities associated with the COMPARE database was developed to evaluate the potential allergenicity of proteins, based on internationally recognized guidelines, FAO/WHO and CODEX Alimentarius Commission

Abstract Cotton GHB811 was developed to confer tolerance to glyphosate and HPPD inhibitor herbicides. The molecular characterisation data and bioinformatic analyses do not identify issues requiring food/feed safety assessment. None of the identified differences in the agronomic/phenotypic and compositional characteristics tested between cotton GHB811 and its conventional counterpart needs further assessment, except for % lint, lint length and dihydrosterculic acid, which do not raise nutritional and safety concerns. The GMO Panel does not identify safety concerns regarding the toxicity and allergenicity of the 2mEPSPS and HPPD W336 proteins as expressed in cotton GHB811 and finds no evidence that the genetic modification would change the overall allergenicity of cotton GHB811. In the context of this application, the consumption of food and feed from cotton GHB811 does not represent a nutritional concern in humans and animals. The GMO Panel concludes that cotton GHB811 is as safe as the conventional counterpart and non‐GM cotton reference varieties tested, and no post‐market monitoring of food/feed is considered necessary. In the case of accidental release of viable cotton GHB811 seeds 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 cotton GHB811. The GMO Panel concludes that cotton GHB811 is as safe as its conventional counterpart and the tested non‐GM cotton reference varieties with respect to potential effects on human and animal health and the environment.

Even though paraquat is considered to be one of the most toxic herbicides, it is one of the most used ones. Paraquat-based preparations are heavily used across many important agricultural countries and for a lot of types of crops such as soya. As soya is used in large quantities in the feed production, paraquat residues in soya products are a potential threat to livestock. The aim of this study was to investigate whether soya products intended for animal feed contain residues of paraquat. Therefore, an optimized Quick Polar Pesticides (QuPPe) Method was developed. In total, 174 samples were analyzed via LC-MS/MS using zwitterionic hydrophilic interaction liquid chromatography (ZIC-HILIC). The results showed that paraquat was detected in 66 % of the samples above 0.008 mg/kg. Residues were mainly present in soya bean meals that were imported from Brazil or the USA and cultivated using genetically modified soya. Around 5 % of the samples were not compliant with the European regulation on maximum residue levels of pesticides in or on food and feed. The results of this study support the view that paraquat residues play a significant role in soya products intended for animal feed and, thus, need to be controlled on a regular basis. However, for enforcement actions reliable processing factors for paraquat in soya products or maximum residue levels for processed soya products are urgently required. [ABSTRACT FROM AUTHOR]

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]

In this research, processed or low processed samples containing corn or corn products (corn semolina, flour, etc.) and soybean were randomly collected from the market, and 25 products in total (chips, nuts, cereals, flour) were analyzed for genetic modification using DNA based detection method, the polymerase chain reaction. First, homogenization of the samples was performed. Then DNA isolation was done by using Cetyl Trimethyl Ammonium Bromide (CTAB) and Roche High Pure DNA Isolation Kit. Since the Roche High Pure DNA Isolation Kit gave better results, the analysis was completed with this method. After DNA isolation, the detection of the Lectin gene, Zein gene, CaMV 35S Promoter and NOS Terminator regions was performed by conventional PCR. Zein gene determination was done for searching and proving corn presence and similarly, Lectin gene determination was done for searching and proving soybean presence in the samples by conventional PCR. GMO3/GMO4 and Zein3/Zein4 primer pairs were used for Lectin and Zein gene determination, respectively. The amplification of DNA was observed in agarose gel electrophoresis. Lectin or Zein genes were detected in 17 samples while these genes were not detected in 8 samples. Samples, in which Lectin or Zein gene was detected were scanned for 35S promoter or NOS terminator. 35S-3/35S-6 and tNOS2F/tNOS2R primer pairs were used for scanning 35S Promoter and NOS Terminator, respectively. To observe possible contamination in the mix sterilized deionized water was used and 0% Bt-11 and 0% GTS 40-3-2 were used as a negative control, 5% Bt-11 and 10% GTS-40-3-2 were used as a positive control. All of the 25 samples did not provide enough DNA with the required quality. This result was considered to be sourced by the applications (frying, extruding, pressing etc.) that samples had been exposed to during processes. Neither 35S Promotor nor NOS Terminator was determined from any of the samples. [ABSTRACT FROM AUTHOR]

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Genetic modification (GM) of crops is a technique that involves the transfer of a genetic material from one organism, including plants, animals, or microorganisms, into a different organism, modifying the plants' characteristics. The technology provides different approaches towards agricultural improvements (environmental, nutritional, yield increases, etc.), which maintained the global food security (quality and safety). However, the opponents have kept on fighting against the technology in a way that merely addresses the potential risks with disregard to the benefits. Some of the arguments which are commonly addressed against the agricultural biotechnology are the negative impacts of overproduction, unnatural biological diversity and the domination of multinational agribusiness corporations. Therefore, the present review reveals an insight towards the negative and positive effects of GM crops on human health and the environment including ethical concerns. The write up will also be an overview that addresses the importance of GM crops and the moral imperative including religious perspectives, thus, providing the public awareness towards accepting the biotechnology. [ABSTRACT FROM AUTHOR]

Plant genome editing, particularly CRISPR-Cas biotechnologies, has rapidly evolved and drawn enormous attention all around the world in the last decade. The cutting-edge technologies have had substantial impact on precise genome editing for manipulating gene expression, stacking gene mutations, and improving crop agronomic traits. Following the global trends, investigations on CRISPR-Cas have been thriving in Australia, especially in agriculture sciences. Importantly, CRISPR-edited plants, classified as SDN-1 organisms (SDN: site-directed nuclease), have been given a green light in Australia, with regulatory bodies indicating they will not be classified as a genetically modified organism (GMO) if no foreign DNA is present in an edited plant. As a result, genome-edited products would not attract the onerous regulation required for the introduction of a GMO, which could mean more rapid deployment of new varieties and products that could be traded freely in Australia, and potentially to export markets. In the present review, we discuss the current status and prospects of plant genome editing in Australia by highlighting several species of interest. Using these species as case studies, we discuss the priorities and potential of plant genome editing, as well as the remaining challenges. [ABSTRACT FROM AUTHOR]

Cotton GHB811 was developed to confer tolerance to glyphosate and HPPD inhibitor herbicides. The molecular characterisation data and bioinformatic analyses do not identify issues requiring food/feed safety assessment. None of the identified differences in the agronomic/phenotypic and compositional characteristics tested between cotton GHB811 and its conventional counterpart needs further assessment, except for % lint, lint length and dihydrosterculic acid, which do not raise nutritional and safety concerns. The GMO Panel does not identify safety concerns regarding the toxicity and allergenicity of the 2mEPSPS and HPPD W336 proteins as expressed in cotton GHB811 and finds no evidence that the genetic modification would change the overall allergenicity of cotton GHB811. In the context of this application, the consumption of food and feed from cotton GHB811 does not represent a nutritional concern in humans and animals. The GMO Panel concludes that cotton GHB811 is as safe as the conventional counterpart and non-GM cotton reference varieties tested, and no post-market monitoring of food/feed is considered necessary. In the case of accidental release of viable cotton GHB811 seeds 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 cotton GHB811. The GMO Panel concludes that cotton GHB811 is as safe as its conventional counterpart and the tested non-GM cotton reference varieties with respect to potential effects on human and animal health and the environment. [ABSTRACT FROM AUTHOR]

Among non-conventional yeasts of industrial interest, the dimorphic oleaginous yeast Yarrowia lipolytica appears as one of the most attractive for a large range of white biotechnology applications, from heterologous proteins secretion to cell factories process development. The past, present and potential applications of wild-type, traditionally improved or genetically modified Yarrowia lipolytica strains will be resumed, together with the wide array of molecular tools now available to genetically engineer and metabolically remodel this yeast. The present review will also provide a detailed description of Yarrowia lipolytica strains and highlight the natural biodiversity of this yeast, a subject little touched upon in most previous reviews. This work intends to fill this gap by retracing the genealogy of the main Yarrowia lipolytica strains of industrial interest, by illustrating the search for new genetic backgrounds and by providing data about the main publicly available strains in yeast collections worldwide. At last, it will focus on exemplifying how advances in engineering tools can leverage a better biotechnological exploitation of the natural biodiversity of Yarrowia lipolytica and of other yeasts from the Yarrowia clade. [ABSTRACT FROM AUTHOR]

• Post-market environmental monitoring of GM crops is mandatory in the EU. • The current practice of PMEM limits its aim of detecting unforeseen adverse effects. • PMEM relies on famers' questionnaires and complaint system, and a literature survey. • Farmers lack the knowledge, time, and motivation to report impacts on biodiversity. • The use of environmental surveillance networks agreed by EFSA should be implemented. The EU legislation requests post-market environmental monitoring (PMEM) of a genetically modified (GM) organism even if its pre-market risk assessment indicated negligible risks. It has been claimed that the monitoring of the only currently commercially cultivated GM plant in the EU, Bt MON810 maize, has not revealed any adverse effects. However, the implementation of its PMEM has been criticised repeatedly by the European Food Safety Authority (EFSA). Although EFSA agreed with the monitoring plan consisting of four tools, as proposed by the company which markets MON810, in practice PMEM has relied on famers' questionnaires, a farmers' complaint system, and a literature survey. The fourth approach, environmental surveillance networks, has not been utilised yet. Furthermore, PMEM requires that farmers plant a refuge of non- Bt maize in order to sustain the efficiency of the plant in combating the targeted pest. This paper aims to contribute to improved PMEM by means of a critical evaluation of its implementation in the Czech Republic based on interviews and a questionnaire survey of farmers who cultivated MON810. The results indicate that a quarter of the farmers who were surveyed did not comply with the refuge requirement. Moreover, farmers often lacked the knowledge, time, and motivation to observe and report the potential impacts of Bt maize on biodiversity, which is supposed to be monitored by the PMEM farmers' questionnaire. The findings of this study compound the previous criticism and suggest that the current practice of PMEM limits its aim of detecting unanticipated adverse effects of MON810 maize cultivation on human and animal health and the environment. The PMEM plan should be revised before the approval process of the application for the renewal of the authorisation for MON810 cultivation in the EU continues. [ABSTRACT FROM AUTHOR]

Genetic Modified Organisms (GMO) are created by manufacturers by introducing genetic material, or DNA, from a different organism through a process called genetic engineering. In most cases the aim is to introduce a new trait to the plant which does not occur naturally in the species like resistance to certain pests, diseases, environmental conditions and herbicides etc. Most currently available GMO foods are plants, such as fruit and vegetables. Existing GM crop includes maize, rice, wheat, soybean, rape, canola, chicory, potato, tomato, cotton etc. GM foods have the potential to solve many of the world’s hunger and malnutrition problems, and to help protect and preserve the environment by increasing yield and reducing reliance upon chemical pesticides. There are many challenges ahead for governments, especially in the areas of safety testing, regulation, industrial policy and food labeling. [ABSTRACT FROM AUTHOR]

The year 2020 has witnessed large number of discoveries in life sciences including agriculture and plant science. Some of these noble works are highlighted in this article. Researches are taken from various news, research blogs, articles and research papers to provide cumulative insights on current trends of R&D in agriculture and plant science. The intent is to apprise the students and researchers of recent trends and discoveries in life sciences including agriculture. [ABSTRACT FROM AUTHOR]

Abstract Background Most genetically modified (GM) plants contain a promoter, P35S, from the plant virus, Cauliflower mosaic virus (CaMV), and many have a terminator, TNOS, derived from the bacterium, Agrobacterium tumefaciens. Assays designed to detect GM plants often target the P35S and/or TNOS DNA sequences. However, because the P35S promoter is derived from CaMV, these detection assays can yield false-positives from non-GM plants infected by this naturally-occurring virus. Results Here we report the development of an assay designed to distinguish CaMV-infected plants from GM plants in a single multiplexed quantitative PCR (qPCR) reaction. Following initial testing and optimization via PCR and singleplex-to-multiplex qPCR on both plasmid and plant DNA, TaqMan qPCR probes with different fluorescence wavelengths were designed to target actin (a positive-control plant gene), P35S, P3 (a CaMV-specific gene), and TNOS. We tested the specificity of our quadruplex qPCR assay using different DNA extracts from organic watercress and both organic and GM canola, all with and without CaMV infection, and by using commercial and industrial samples. The limit of detection (LOD) of each target was determined to be 1% for actin, 0.001% for P35S, and 0.01% for both P3 and TNOS. Conclusions This assay was able to distinguish CaMV-infected plants from GM plants in a single multiplexed qPCR reaction for all samples tested in this study, suggesting that this protocol is broadly applicable and readily transferrable to any interested parties with a qPCR platform.

Abstract Oilseed rape 73496 was developed to confer tolerance to the herbicidal active substance glyphosate through the expression of the glyphosate acetyltransferase protein GAT4621. The molecular characterisation data and bioinformatic analyses identify no issues requiring food/feed safety assessment. None of the identified differences between oilseed rape 73496 and its conventional counterpart in the agronomic/phenotypic endpoints tested needs further assessment. Differences identified in seed composition of oilseed rape 73496 as compared to its conventional counterpart raise no safety and nutritional concerns in the context of the scope of this application. No safety concerns are identified regarding toxicity and allergenicity of the GAT4621 protein as expressed in oilseed rape 73496. No evidence is found that the genetic modification would change the overall allergenicity of oilseed rape 73496. Based on the outcome of the comparative and nutritional assessments, the consumption of oilseed rape 73496 does not represent any nutritional concern, in the context of the scope of this application. The implementation of a post‐market monitoring plan is recommended to confirm the predicted consumption data and to verify that the conditions of use are those considered during the pre‐market risk assessment. In the case of accidental release of viable oilseed rape 73496 seeds into the environment, oilseed rape 73496 would not raise environmental safety concerns. The post‐market environmental monitoring plan and reporting intervals are in line with the intended uses of oilseed rape 73496. The GMO Panel concludes that oilseed rape 73496, as described in this application, is as safe as its conventional counterpart and the non‐genetically modified oilseed rape reference varieties tested with respect to potential effects on human and animal health and the environment.

Abstract The European Commission mandated EFSA to complement its original scientific opinion on soybean MON 87769 × MON 89788 (EFSA‐GMO‐NL‐2010‐85) considering additional information on the human nutritional assessment of refined bleached deodorised oil produced from the two‐event stack soybean (RBD GM‐oil). The assessment was mainly based on a replacement scenario with a list of target foods where RBD GM‐oil is intended to be added. Intake estimations for several fatty acids present in the RBD GM‐oil, in particular γ‐linolenic acid (GLA), stearidonic acid (SDA) and linoleic acid (LA) were based on the consumption of the corresponding foods that are likely to be displaced. The assessment of LA considered the established adequate intake of 4% of total energy intake (E%) and that LA deficiency has not been observed with intakes > 1 E%. The assessment of GLA and SDA was conducted using maximum doses without adverse effects from intervention human studies as reference (4.2 grams/day for SDA and 2.8 grams/day for GLA) since no tolerable upper intake levels are set for these fatty acids. The decrease observed in the levels of LA in RBD GM‐oil as compared to oil from conventional soybean does not represent a nutritional concern as intakes were in all cases above 1 E%. For GLA, all intake estimations were below the reference dose indicating no safety concern. SDA intake estimations do not pose any safety concerns based on the overly conservative nature of the estimates, the absence of toxicological hazards and the rapid metabolism of SDA in humans. The GMO Panel concluded that the consumption of soybean MON 87769 × MON 89788 and their derived products, in particular its RBD oil, does not represent a nutritional concern in humans. A post‐market monitoring plan is recommended to confirm the predicted consumption and the application of conditions of uses considered during the pre‐market risk assessment.

Abstract Soybean GMB151 was developed to confer tolerance to 4‐hydroxyphenylpyruvate dioxygenase (HPPD) inhibitor herbicides and resistance to nematodes. The molecular characterisation data and bioinformatic analyses do not identify issues requiring food/feed safety assessment. None of the identified differences in the agronomic/phenotypic and compositional characteristics tested between soybean GMB151 and its conventional counterpart needs further assessment, except for palmitic acid and heptadecenoic acid in seeds and carbohydrate and crude protein in forage, which does not raise nutritional and safety concerns. The GMO Panel does not identify safety concerns regarding the toxicity and allergenicity of the HPPD‐4 and Cry14Ab‐1 proteins as expressed in soybean GMB151, and finds no evidence that the genetic modification would change the overall allergenicity of soybean GMB151. In the context of this application, the consumption of food and feed from soybean GMB151 does not represent a nutritional concern in humans and animals. The GMO Panel concludes that soybean GMB151 is as safe as the conventional counterpart and non‐GM soybean reference varieties tested, and no post‐market monitoring of food/feed is considered necessary. In the case of accidental release of viable soybean GMB151 seeds 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 soybean GMB151. The GMO Panel concludes that soybean GMB151 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.

Oilseed rape 73496 was developed to confer tolerance to the herbicidal active substance glyphosate through the expression of the glyphosate acetyltransferase protein GAT4621. The molecular characterisation data and bioinformatic analyses identify no issues requiring food/feed safety assessment. None of the identified differences between oilseed rape 73496 and its conventional counterpart in the agronomic/phenotypic endpoints tested needs further assessment. Differences identified in seed composition of oilseed rape 73496 as compared to its conventional counterpart raise no safety and nutritional concerns in the context of the scope of this application. No safety concerns are identified regarding toxicity and allergenicity of the GAT4621 protein as expressed in oilseed rape 73496. No evidence is found that the genetic modification would change the overall allergenicity of oilseed rape 73496. Based on the outcome of the comparative and nutritional assessments, the consumption of oilseed rape 73496 does not represent any nutritional concern, in the context of the scope of this application. The implementation of a post‐market monitoring plan is recommended to confirm the predicted consumption data and to verify that the conditions of use are those considered during the pre‐market risk assessment. In the case of accidental release of viable oilseed rape 73496 seeds into the environment, oilseed rape 73496 would not raise environmental safety concerns. The post‐market environmental monitoring plan and reporting intervals are in line with the intended uses of oilseed rape 73496. The GMO Panel concludes that oilseed rape 73496, as described in this application, is as safe as its conventional counterpart and the non‐genetically modified oilseed rape reference varieties tested with respect to potential effects on human and animal health and the environment. [ABSTRACT FROM AUTHOR]

The European Commission mandated EFSA to complement its original scientific opinion on soybean MON 87769 x MON 89788 (EFSA-GMO-NL-2010-85) considering additional information on the human nutritional assessment of refined bleached deodorised oil produced from the two-event stack soybean (RBD GM-oil). The assessment was mainly based on a replacement scenario with a list of target foods where RBD GM-oil is intended to be added. Intake estimations for several fatty acids present in the RBD GM-oil, in particular γ-linolenic acid (GLA), stearidonic acid (SDA) and linoleic acid (LA) were based on the consumption of the corresponding foods that are likely to be displaced. The assessment of LA considered the established adequate intake of 4% of total energy intake (E%) and that LA deficiency has not been observed with intakes > 1 E%. The assessment of GLA and SDA was conducted using maximum doses without adverse effects from intervention human studies as reference (4.2 grams/day for SDA and 2.8 grams/day for GLA) since no tolerable upper intake levels are set for these fatty acids. The decrease observed in the levels of LA in RBD GM-oil as compared to oil from conventional soybean does not represent a nutritional concern as intakes were in all cases above 1 E%. For GLA, all intake estimations were below the reference dose indicating no safety concern. SDA intake estimations do not pose any safety concerns based on the overly conservative nature of the estimates, the absence of toxicological hazards and the rapid metabolism of SDA in humans. The GMO Panel concluded that the consumption of soybean MON 87769 x MON 89788 and their derived products, in particular its RBD oil, does not represent a nutritional concern in humans. A post-market monitoring plan is recommended to confirm the predicted consumption and the application of conditions of uses considered during the pre-market risk assessment. [ABSTRACT FROM AUTHOR]

An antifungal drug Itraconazole is an azole derivative that belongs to BCS class II. Itraconazole with 14-α demethylase, a cytochrome P-450 enzyme obligatory to convert lanosterol to ergosterol; as ergosterol is an imperative component of the fungal cell wall. The present research work aims to extend the penetration of Itraconazole into deeper layers of skin by formulating cubosomes of Itraconazole into a topical emulgel that helps in enhancing the bioavailability by avoiding first-pass metabolism. Cubosomes were prepared by the Top-down approach (Emulsification method) employing GMO as a lipid phase vehicle, Pluronic F127 as a stabilizer, and distilled water as the aqueous phase. Itraconazole is an antifungal drug with 55% oral bioavailability. Consequential formulations were characterized by visual inspection, encapsulation efficiency, in-vitro drug release, particle size, zeta potential. Optimized formulation (F4) showed drug release of 89.76% within 9 hours, the particle size of 259.8 d.nm, and zeta potential of -34.4 mV. The optimized Cubosome formulation F4 was used for the Itraconazole emulgel using carbopol 974N, HPMC 15cps, and studied for pH, viscosity, drug content and in vitro drug release. Among all the preparations, formulation ITF7 was found to illustrate the utmost drug release of 86.93% at the closing stages of 20 hours and other evaluation parameters within specified limits. In vitro release kinetics exhibited sustained release and therefore the formulation ITF7 follows the Higuchi release mechanism and according to this model, the Itraconazole cubosomal emulgel formulation released the drug throughout non-Fickian super case-II transport (n > 0.89). This novel cubosomal, low-irritant gel would be a promising system for effectual topical drug delivery. [ABSTRACT FROM AUTHOR]

Bt-corn, which is one of the most cultivated transgenic corn lines in the world, can synthesize the Cryl Ab insecticidal protein produced by Bacillus thuringiens subsp. kurstaki bacteria. In this study, possible effects of genetic modifications in genetically modified Bt corn on germination and early seedling the periods were determined. Micronucleus formation, chromosomal aberrations, germination success and morphological characteristics were examined during the germination phase. Stomatal density, pigment content, malondialdehyde and praline contents ofleaves and seedling morphology were examined in the early seedling period. According to the results of this study, Bt corn had a shorter seedling length but larger leaf area. In addition, anthocyanin content and praline levels and anterior and posterior stomata! densities were higher in Bt corn. Consequently, genetic modification did not lead to noticeable changes which may affect the yield. However, the increased levels of anthocyanin and praline in Bt corn indicated an oxidative stress that the plant was able to overcome. [ABSTRACT FROM AUTHOR]

Soybean GMB151 was developed to confer tolerance to 4‐hydroxyphenylpyruvate dioxygenase (HPPD) inhibitor herbicides and resistance to nematodes. The molecular characterisation data and bioinformatic analyses do not identify issues requiring food/feed safety assessment. None of the identified differences in the agronomic/phenotypic and compositional characteristics tested between soybean GMB151 and its conventional counterpart needs further assessment, except for palmitic acid and heptadecenoic acid in seeds and carbohydrate and crude protein in forage, which does not raise nutritional and safety concerns. The GMO Panel does not identify safety concerns regarding the toxicity and allergenicity of the HPPD‐4 and Cry14Ab‐1 proteins as expressed in soybean GMB151, and finds no evidence that the genetic modification would change the overall allergenicity of soybean GMB151. In the context of this application, the consumption of food and feed from soybean GMB151 does not represent a nutritional concern in humans and animals. The GMO Panel concludes that soybean GMB151 is as safe as the conventional counterpart and non‐GM soybean reference varieties tested, and no post‐market monitoring of food/feed is considered necessary. In the case of accidental release of viable soybean GMB151 seeds 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 soybean GMB151. The GMO Panel concludes that soybean GMB151 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]

BACKGROUND: PfFAD3 transgenic soybean expressing omega‐3 fatty acid desaturase 3 of Physaria produces increased level of α‐linolenic acid in seed. Composition data of non‐transgenic conventional varieties is important in the safety assessment of the genetically‐modified (GM) crops in the context of the natural variation. RESULTS: The natural variation was characterized in seed composition of 13 Korean soybean varieties grown in three locations in South Korea for 2 years. Univariate analysis of combined data showed significant differences by variety and cultivation environment for proximates, minerals, anti‐nutrients, and fatty acids. Percent variability analysis demonstrated that genotype, environment and the interaction of environment with genotype contributed to soybean seed compositions. Principal component analysis and orthogonal projections to latent structure discriminant analysis indicated that significant variance in compositions was attributable to location and cultivation year. The composition of three PfFAD3 soybean lines for proximates, minerals, anti‐nutrients, and fatty acids was compared to a non‐transgenic commercial comparator (Kwangankong, KA), and three non‐transgenic commercial varieties grown at two sites in South Korea. Only linoleic and linolenic acids significantly differed in PfFAD3‐1 lines compared to KA, which were expected changes by the introduction of the PfFAD3‐1 trait in KA. CONCLUSION: Genotype, environment, and the interaction of environment with genotype contributed to compositional variability in soybean. PfFAD3‐1 soybean is equivalent to the conventional varieties with respect to these components. © 2020 The Authors. Journal of The Science of Food and Agriculture published by John Wiley & Sons Ltd on behalf of Society of Chemical Industry. [ABSTRACT FROM AUTHOR]

Along the ports of Japan, civilians have made a peculiar discovery: in a country where genetically modified (GM) crop cultivation is prohibited, wild canola weeds flourishing in the cracks of sidewalks are exhibiting the GM trait of herbicide resistance to Monsanto's infamous glyphosate. Able to enter the archipelagic country via unregulated channels and to cross-pollinate with locally grown crops, the weeds threaten to make inroads into the food system in ways unbeknownst to human actors. Among the most vocal of groups responding to this urban ecological threat are Japanese women and mothers involved in consumer co-operative systems. This article documents the emergence of their activism to demonstrate how situated and transformative political action is key to the political ecological study of human-plant encounters. It does so by interrogating the notion of weedyactivism as a way to see plants not only as the object of political action, but also as a conceptual heuristic for understanding the kinds of political subjects that emerge in interaction with local environments.

Poziom wiedzy społeczeństwa nt. GMO stale się zmienia. W listopadzie i grudniu 2019 r. studenci UKSW w Warszawie przeprowadzili ankiety wśród 699 anonimowych respondentów na temat zastosowania produktów GMO w codziennym życiu Polaków. Osoby ankietowane podzielono wg czterech kryteriów: płci, wieku, wykształcenia i miejsca zamieszkania z podziałem na miasto i wieś, zadając 7 pytań merytorycznych odnośnie do poziomu wiedzy i osobistego podejścia do konsumpcji produktów GMO. Analizę statystyczną wyników wykonano w programie STATISTICA 12. Wykazano, że w ostatnich latach rośnie wiedza mieszkańców w Polsce nt. GMO, ale obawy przed produktami genetycznie modyfikowanymi nadal występują u ponad połowy społeczeństwa. Większość kobiet obawia się GMO, zwraca większą uwagę na oznakowanie produktów zawierających GMO i nie podałaby ich swoim dzieciom. Osoby w wieku poniżej 20 lat są pozytywnie nastawione do GMO, natomiast osoby w wieku powyżej 35 lat obawiają się negatywnych skutków spożywania produktów GMO. Większość osób mieszkających na wsi obawia się produktów GMO, opinia zaś mieszkańców miasta jest podzielona na dwie, prawie równe grupy: zarówno zwolenników, jak i przeciwników GMO. Różnice w odpowiedziach odnośnie obawy przed negatywnymi skutkami spożywania produktów zawierających GMO były statystycznie istotne (p < 0,001) i wykazały większe obawy wśród osób zamieszkujących tereny wiejskie (67%) niż u mieszkańców miast (49%). Jednocześnie, prawie ten sam duży odsetek osób ze wsi i z miasta (67%) był przychylny stosowaniu leków wyprodukowanych drogą inżynierii genetycznej (p < 0,01).

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.

The Genetically Modified (GMO) Corn Experiment was performed to test the hypothesis that wild animals prefer Non-GMO corn and avoid eating GMO corn, which resulted in the collection of complex image data of consumed corn ears. This study develops a deep learning-based image processing pipeline that aims to estimate the consumption of corn by identifying corn and its bare cob from these images, which will aid in testing the hypothesis in the GMO Corn Experiment. Ablation uses mask regional convolutional neural network (Mask R-CNN) for instance segmentation. Based on image data annotation, two approaches for segmentation were discussed: identifying whole corn ears and bare cob parts with and without corn kernels. The Mask R-CNN model was trained for both approaches and segmentation results were compared. Out of the two, the latter approach, i.e., without the kernel, was chosen to estimate the corn consumption because of its superior segmentation performance and estimation accuracy. Ablation experiments were performed with the latter approach to obtain the best model with the available data. The estimation results of these models were included and compared with manually labeled test data with R2 = 0.99 which showed that use of the Mask R-CNN model to estimate corn consumption provides highly accurate results, thus, allowing it to be used further on all collected data and help test the hypothesis of the GMO Corn Experiment. These approaches may also be applied to other plant phenotyping tasks (e.g., yield estimation and plant stress quantification) that require instance segmentation.

Abstract Maize MON 87427 × MON 87460 × MON 89034 × 1507 × MON 87411 × 59122 (six‐event stack maize) was produced by conventional crossing to combine six single events: MON 87427, MON 87460, MON 89034, 1507, MON 87411 and 59122. The GMO Panel previously assessed the six single maize events and 17 of the subcombinations and did not identify safety concerns. No new data on the single maize events or the 17 subcombinations were identified that could lead to modification of the original conclusions on their safety. The molecular characterisation, comparative analysis (agronomic, phenotypic and compositional characteristics) and the outcome of the toxicological, allergenicity and nutritional assessment indicate that the combination of the single maize events and of the newly expressed proteins and dsRNA in the six‐event stack maize does not give rise to food and feed safety and nutritional concerns. The GMO Panel concludes that the six‐event stack maize, as described in this application, is as safe as its non‐GM comparator and the selected non‐GM reference varieties. In the case of accidental release of viable grains of the six‐event stack maize into the environment, this would not raise environmental safety concerns. The GMO Panel assessed the likelihood of interactions among the single events in the 39 maize subcombinations not previously assessed and concludes that these are expected to be as safe as the single events, the previously assessed subcombinations and the six–event stack maize. The post‐market environmental monitoring plan and reporting intervals are in line with the intended uses of the six‐event stack maize. Post‐market monitoring of food/feed is not considered necessary. The GMO Panel concludes that the six‐event stack maize and its subcombinations are as safe as the non‐GM comparator and the selected non‐GM reference varieties with respect to potential effects on human and animal health and the environment.

Abstract 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 Maize 1507 × MIR162 × MON810 × NK603 (four‐event stack maize) was produced by conventional crossing to combine four single events: 1507, MIR162, MON810 and NK603. The GMO Panel previously assessed the four single events and six of the subcombinations and did not identify safety concerns. No new data on the single events or the six subcombinations that could lead to modification of the original conclusions on their safety were identified. The molecular characterisation, comparative analysis (agronomic, phenotypic and compositional characteristics) and the outcome of the toxicological, allergenicity and nutritional assessment indicate that the combination of the single maize events and of the newly expressed proteins in the four‐event stack maize does not give rise to food and feed safety and nutritional concerns. The GMO Panel concludes that the four‐event stack maize, as described in this application, is as safe as its non‐GM comparator and the non‐GM reference varieties tested. In the case of accidental release of viable seeds of the four‐event stack maize into the environment, this would not raise environmental safety concerns. The GMO Panel assessed the likelihood of interactions among the single events in the four maize subcombinations not previously assessed and concludes that these are 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 the four‐event stack maize. Post‐market monitoring of food/feed is not considered necessary. The GMO Panel concludes that the four‐event stack maize and its subcombinations are as safe as the non‐GM comparator and the tested non‐GM reference varieties with respect to potential effects on human and animal health and the environment.

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.

Robust methods of predicting how gene drive systems will interact with ecosystems is essential for safe deployment of gene drive technology. We describe how quantitative tools can reduce risk uncertainty, streamline empirical research, guide risk management, and promote cross-sector collaboration throughout the process of gene drive technology development and implementation. [ABSTRACT FROM AUTHOR]

In this paper, we explore how the politics of European regulation and risk governance for innovative agricultural biotechnologies, with the continuing emphasis on the precautionary principle, has problematised conventional norms of evidence-based risk-related decision-making. Based on a study we conducted that analysed how the EU regulatory system had operated in practice in the context of two of the company Syngenta's genetically modified (GM) crops (Bt11 and GA21), and through two stakeholder workshops, we highlight the tensions in the current regulatory system in Europe, the implications for the future regulation of new and emerging advanced agricultural biotechnologies in the EU, and suggest areas where there may be a need for further regulatory adjustment. [ABSTRACT FROM AUTHOR]

Background: Various databases on genetically modified organisms (GMOs) exist, all with their specific focus to facilitate access to information needed for, e. g., the assistance in risk assessment, the development of detection and identification strategies or inspection and control activities. Each database has its unique approach towards the subject. Often these databases use different terminology to describe the GMOs. For adequate GMO addressing and identification and exchange of GMO-related information it is necessary to use commonly agreed upon concepts and terminology. Result: A hierarchically structured controlled vocabulary describing the genetic elements inserted into conventional GMOs, and GMOs developed by the use of gen(om)e-editing is presented: the GMO genetic element thesaurus (GMO-GET). GMO-GET can be used for GMO-related documentation, including GMO-related databases. It has initially been developed on the basis of two GMO databases, i.e. the Biosafety Clearing-House and the EUginius database. Conclusion: The use of GMO-GET will enable consistent and compatible information (harmonisation), also allowing an accurate exchange of information between the different data systems and thereby facilitating their interoperability. GMO-GET can also be used to describe genetic elements that are altered in organisms obtained through current targeted genome-editing techniques. [ABSTRACT FROM AUTHOR]

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]

Bt com, a transgenic crop, was improved genetically to produce the insecticidal toxin encoded by the crylAb gene. In this study, possible effects of gene insertion were assessed by means of nutritional composition and antioxidant defence properties in com grains. Total protein and total oil contents were lower in Bt corn grains while proline and MDA levels of Bt corn were significantly higher when compared to non-Bt com grains. Fatty acid and carbohydrate compositions exhibited significant differences between the genotypes. In both genotypes, the most abundant fatty acids were linoleic and oleic acids. The most remarkable alteration in carbohydrate composition was ten times higher saccharose accumulation of Bt com. Total phenolic and total flavonoid levels of Bt com were significantly lower than non-Bt counterpart. Antioxidant enzyme activities were evaluated in 48 hours-imbibed and 48 hoursgerminated grains of Bt and non-Bt com. According to superoxide dismutase (SOD), guaiacol-peroxidase (POD) and glutathione reductase (GR) activities, genetic modification brought about remarkable alterations in antioxidant defence metabolism. [ABSTRACT FROM AUTHOR]

The discussion about the impact of agricultural biotechnology on Africa is deeply divided and contains widely diverging claims about the impact of biotechnology on African farmers. Building upon literature on the 'good farmer' that highlights that farmers identities are an important factor in explaining the success or failure of agricultural change, we argue that the identity of the farmer is an undervalued yet crucial aspect for understanding the debate about the impact of agricultural biotechnology on African farmers. In this article we therefore investigate what farmers' identities are implicated in the arguments about the impact of biotechnology on African farmers. We aim to identify the main fault lines in different accounts of the African biotechnology farmer by analysing the identities ascribed to them in two prominent cases of controversy: the debates at the 2002 World Summit on Sustainable Development in Johannesburg and the discussion about the impact of biotechnology on smallholder farmers in the Makhathini flats in KwaZulu Natal, South Africa. Our findings demonstrate that arguments about biotechnology are informed by diverging conceptions of who the African farmer is, what is important for the African farmer, and what role the African farmer has in relation to agricultural biotechnology. These findings remain relevant for current discussions on gene editing technologies like CRISPR-Cas. Openly discussing these different views on the identity of smallholder farmers is crucial for moving forward in the biotechnology controversy and can inform future attempts to elicit the farmer's voice. [ABSTRACT FROM AUTHOR]

• Detection of some gene edited plants may not be feasible with current technology. • Authorization of gene edited plants in the EU may not be possible in some cases. • Current interpretation of GMO legislation leads to legally unacceptable consequences. • Revision of GMO law is necessary. According to a predominant interpretation of the C-528/16 judgment of the Court of Justice of the European Union, mutants resulting from gene editing, even those featuring only single nucleotide variants, should be subject to the authorization procedures designed for organisms developed through genetic modification (i.e. insertion of large DNA fragments). In this article, we illustrate practical problems with the authorization of products of gene editing in the EU. On the basis of these problems, we analyze the influence of the current interpretation of EU legislation and judgment on the practical ability to authorize and detect such products on the EU market. We show that the predominant interpretation of the judgment leads to legally unacceptable consequences, in particular to the violation of the principle of proportionality with regard to individuals who wish to develop and market products of gene editing. As a result of our considerations, we show that the C-528/16 judgment did not need to be interpreted in the dominant way. [ABSTRACT FROM AUTHOR]

Maize MON 87427 x MON 87460 x MON 89034 x 1507 x MON 87411 x 59122 (six-event stack maize) was produced by conventional crossing to combine six single events: MON 87427, MON 87460, MON 89034, 1507, MON 87411 and 59122. The GMO Panel previously assessed the six single maize events and 17 of the subcombinations and did not identify safety concerns. No new data on the singlemaize events or the 17 subcombinations were identified that could lead to modification of the original conclusions on their safety. The molecular characterisation, comparative analysis (agronomic, phenotypic and compositional characteristics) and the outcome of the toxicological, allergenicity and nutritional assessment indicate that the combination of the single maize events and of the newly expressed proteins and dsRNA in the six-event stack maize does not give rise to food and feed safety and nutritional concerns. The GMO Panel concludes that the six-event stack maize, as described in this application, is as safe as its non-GM comparator and the selected non-GM reference varieties. In the case of accidental release of viable grains of the six-event stack maize into the environment, this would not raise environmental safety concerns. The GMO Panel assessed the likelihood of interactions among the single events in the 39 maize subcombinations not previously assessed and concludes that these are expected to be as safe as the single events, the previously assessed subcombinations and the six--event stack maize. The post-market environmental monitoring plan and reporting intervals are in line with the intended uses of the six-event stack maize. Post-market monitoring of food/feed is not considered necessary. The GMO Panel concludes that the six-event stack maize and its subcombinations are as safe as the non-GM comparator and the selected non-GM reference varieties with respect to potential effects on human and animal health and the environment. [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]

Maize 1507 x MIR162 x MON810 x NK603 (four-event stack maize) was produced by conventional crossing to combine four single events: 1507, MIR162, MON810 and NK603. The GMO Panel previously assessed the four single events and six of the subcombinations and did not identify safety concerns. No new data on the single events or the six subcombinations that could lead to modification of the original conclusions on their safety were identified. The molecular characterisation, comparative analysis (agronomic, phenotypic and compositional characteristics) and the outcome of the toxicological, allergenicity and nutritional assessment indicate that the combination of the single maize events and of the newly expressed proteins in the four-event stack maize does not give rise to food and feed safety and nutritional concerns. The GMO Panel concludes that the four-event stack maize, as described in this application, is as safe as its non-GM comparator and the non-GM reference varieties tested. In the case of accidental release of viable seeds of the four-event stack maize into the environment, this would not raise environmental safety concerns. The GMO Panel assessed the likelihood of interactions among the single events in the four maize subcombinations not previously assessed and concludes that these are 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 the four-event stack maize. Post-market monitoring of food/feed is not considered necessary. The GMO Panel concludes that the four-event stack maize and its subcombinations are as safe as the non-GM comparator and the tested non-GM reference varieties with respect to potential effects on human and animal health and the environment. [ABSTRACT FROM AUTHOR]