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This study analyzes Paraguay's biotechnology regulatory framework and its alignment with international standards amid biotechnological advancements. It also identifies areas of improvement for enhancing framework effectiveness. Through this work, we aim to provide a resource for policymakers, stakeholders, and researchers navigating Paraguay's biotechnology regulation.

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The objective of this review is to bring information about innovations and technologies that, through genetic improvement, are being used to improve the sustainability and productivity of agricultural crops, improve human nutrition, as well as conservation and decontamination of soils. Bioremediation consists of using microorganisms that have the ability to modify or decompose certain pollutants, with the possibility of increasing their activity through genetic engineering, building new strains for the transformation of pollutants into inert substances. Genetic improvement is seeking to develop cultivars that are more tolerant to periods of water deficit. Plant biofortification consists of varieties of improved plants that have a higher content of vitamins and minerals, which are obtained through genetic improvement. Thus, biotechnology is once again essential for world agricultural production and can bring a series of other benefits to society.(AU)

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The term new genomic techniques (NGTs) is an umbrella term used to describe a variety of techniques that can alter the genetic material of an organism and that have emerged or have been developed since 2001, when the existing genetically modified organism (GMO) legislation was adopted. The analytical framework used to detect GMOs in Europe is an established single harmonized procedure that is mandatory for the authorization of GM food and feed, thus generating a reliable, transparent, and effective labeling scheme for GMO products. However, NGT products can challenge the implementation and enforcement of the current regulatory system in the EU, relating in particular to the detection of NGT products that contain no foreign genetic material. Consequently, the current detection methods might fail to meet the minimum performance requirements. Although existing detection methods may be able to detect and quantify even small alterations in the genome, this does not necessarily confirm the distinction between products resulting from NGTs subject to the GMO legislation and other products. Therefore, this study provides a stepwise approach for the in silico prediction of PCR systems' specificity by testing a bioinformatics pipeline for amplicon and primer set searches in current genomic databases. In addition, it also empirically tested the PCR system evaluated during the in silico analysis. Two mutant genotypes produced by CRISPR-Cas9 in Arabidopsis thaliana were used as a case study. Overall, our results demonstrate that the single PCR system developed for identifying a nucleotide insertion in the grf1-3 genotype has multiple matches in the databases, which do not enable the discrimination of this mutated event. Empirical assays further support this demonstration. In contrast, the second mutated genotype, grf8-61, which contains a -3 bp deletion, did not yield any matches in the sequence variant database. However, the primer sequences were not efficient during the empirical assay. Our approach represents a first step in decision making for analytical methods for NGT detection, identification, and quantification in light of the European labeling regulations.

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Resumo Diante da existência de incertezas científicas em relação à segurança dos transgênicos para a saúde humana e considerando o Princípio da Precaução e preceitos constitucionais em vigor, o consumidor deve ter o direito de ser informado de maneira adequada sobre a presença de transgênicos nos alimentos, por meio da rotulagem. Este ensaio tem por objetivo apresentar as implicações acerca da nova proposta de rotulagem de transgênicos no Brasil. A atual legislação brasileira de rotulagem de alimentos transgênicos e agências governamentais envolvidas não garantem que os produtos não identificados como tal sejam livres de transgênicos. A aprovação do PLC nº 34/2015 contraria dispositivos do Código de Defesa do Consumidor, indo na contramão da escolha e autonomia do consumidor. Além disso, a biovigilância será mais ainda inepta a executar uma atividade de identificação e apreensão de produtos que venham causar danos à saúde humana, animal e ao meio ambiente. A mudança proposta representa um retrocesso na regulamentação de rotulagem de transgênicos vigente no Brasil e um desrespeito aos direitos individuais e coletivos previstos na Constituição Federal, no Código de Defesa do Consumidor e em acordos internacionais assinados pelo Brasil.

Abstract Given the uncertainty surrounding the safety of genetically modified organisms (GMOs), the precautionary principle and constitution provide that consumers should have the right to access adequate information on the presence of transgenics through food labelling. This article discusses the implications of proposed modifications to GM food labelling in Brazil. Current labelling legislation and the government agencies involved in labelling do not guarantee that food products not bearing GMO labels are free of transgenics. The approval of Chamber of Deputies Bill No. 34/2015 goes against the Consumer Protection Code by undermining consumer autonomy and choice. In addition, it is likely to weaken the country's biosurveillance capabilities to identify and seize products that have a harmful effect on the health of humans, animals and the environment. The proposed changes constitute a retrograde step in the regulation of food labelling in Brazil and violate the individual and collective rights enshrined in the Federal Constitution, Consumer Protection Code, and international agreements signed by Brazil.

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Introduction: The acceptance of genetically modified organisms (GMOs) by the civilian population in Ecuador is a controversial issue, where beliefs and practices are determinant. In Ecuador, the use of GMOs for research or productive purposes has been banned since 2008; however, the current position of the population toward this technology is unknown. Objective: The aim of the study was to explain the attitude toward GMOs in the Ecuadorian university population based on sociodemographic variables, knowledge, beliefs, practices, and bioethical approach. Methods: A validated survey was applied to 719 students and teachers of the Catholic University of Cuenca through Google Forms. The collected data were processed using SPSS 23.0 software. Multivariate and linear regression analyses were used to explain the attitude toward GMOs based on the variables studied. Results: Partial approval of GMO use is research-oriented, with a rejection toward food. The linear regression model explained 65% of the variance of attitude toward GMOs from the beliefs, practices, knowledge, and bioethical approach variables. The sociodemographic variables were completely excluded from the model due to the absence of statistical significance. Conclusions: The incipient acceptance of GMOs in the academic sector corroborates a transformation in the thinking of Ecuadorian civil society. Considerations on the use of GMOs are supported by a bioethical approach that leans toward a pragmatic utilitarianism based on the immediate or mediate benefits of the technology.

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Abstract Developments in applying biotechnology to crops have generated strong ethical and social debates about its use. This study was aimed at reviewing epidemiological evidence regarding the consumption of genetically modified foods and the possible effects on human health, particularly certain insect-resistant crops in which isolated Bacillum thurigiensis Cry protein has been introduced. An in-depth review of databases was conducted for 2007-2019. Articles not referring to human health were excluded. In total, 1,350 were obtained and 118 were reviewed. As a result, it can be concluded that most studies have focused on chemical composition and in vitro or laboratory animal trials. Furthermore, the guiding principle of substantial equivalency, generally used today to evaluate potential health effects, should not replace rigorously evaluating products with nutritional, immunological, and toxicological trials. Lastly, this review demonstrates a lack of epidemiological evidence, and therefore, the safety of these foods cannot be conclusively determined based on evidence.

Resumen El desarrollo de la biotecnología aplicada a los cultivos ha generado fuertes debates éticos y sociales sobre su uso. El presente estudio tuvo por objetivo revisar las evidencias epidemiológicas existentes relacionando el consumo de alimentos genéticamente modificados, en particular aquellos provenientes de cultivos con resistencia a algunos insectos plagas en los que se han introducido proteínas Cry aisladas de Bacillum thurigiensis con probables daños o trastornos en la salud de las personas. Se realizó una revisión en profundidad en el periodo 2007 a 2019, en bases de datos. Se excluyeron aquellos artículos que no hacían referencia a salud humana. Se obtuvieron 1 350 y finalmente se revisaron 118. La revisión permitió concluir que la mayoría de los estudios existentes se centran en información respecto a la composición química y ensayos in vitro o en laboratorio con animales. Igualmente, que el principio rector de equivalencia sustancial hoy utilizado en forma generalizada para la evaluación de potenciales efectos en salud, no debería sustituir la necesidad de una evaluación rigurosa de los productos incluyendo ensayos nutricionales, inmunológicos y toxicológicos. Por último se comprueba también que la evidencia epidemiológica incluida es insuficiente por lo que lo que no es posible concluir a partir de ella, sobre la inocuidad de estos alimentos.

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The hG-CSF (human Granulocyte Colony-Stimulating Factor) is a growth and stimulation factor capable of inducing the proliferation of bone marrow cells, several types of leukocytes, among other hematopoietic tissue cells. hG-CSF is used in used to treat anomalies that reder a small number of circulating white blood cells, which may compromise the immune defenses of the affected person. For these reasons, the production of hG-CSF in a bioreactor system using the mammary gland of genetic modified animals is a possibility of adding value to the bovine genetic material and reducing the costs of hG-CSF production in pharmaceutical industry. In this study, we aimed the production of transgenic hG-CSF bovine through the lipofection of bovine primary fibroblasts with an hG-CSF expression cassette and cloning these fibroblasts by the somatic cell nuclear transfer (SCNT) technique. The bovine fibroblasts transfected with the hG-CSF cassette presented a stable insertion of this construct into their genome and were efficiently synchronized to G0/G1 cell cycle stage. The transgenic fibroblasts were cloned by SCNT and produced 103 transferred embryos and 2 pregnancies, one of which reached 7 months of gestation.

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Direct and indirect induced defense mechanisms against herbivores can be manifested in maize (Zea mays L.) plants. Furthermore, there are constitutive defenses in which plants continuously express resistance traces. In recent decades has increased the production of transgenic maize plants that constitutively express proteins with insecticide action (Bt maize). The increase of the use of transgenic maize cultivars with the Bt (Bacillus thuringiensis) gene demand studies that evaluate the impacts caused by this technology on plant defense mechanisms and their impact on non-targeted organisms, as the two-spotted spider mite Tetranychus urticae Koch (Acari: Tetranychidae). We tested the hypothesis that Bt maize plants (expressing Cry1F protein) would be capable of inducing direct defenses to T. urticae after being attacked by these mites. Thus, we used plants of a commercial maize hybrid (30F35 Hx - expressing Cry1F protein) and plants of its respective non-Bt isogenic line (control). We compared the survival and reproductive performances of T. urticae on plants of both lines that were previously infested with conspecifics and on plants that did not suffer pre-infestations. The previous infestation of maize plants by T. urticae did not impacted the survival and reproductive abilities of adult and immature forms of the conspecific in both genotypes. These results suggest that, Bt maize expressing the Cry1F insecticidal protein, does not interfere in the induction of direct defense by the T. urticae when compared with conventional maize plants.

Mecanismos diretos e indiretos de defesa induzida contra herbívoros podem manifestar-se em plantas de milho (Zea mays.). Além das defesas induzidas, existem as defesas constitutivas, nas quais as plantas expressam a resistência de forma contínua. Nas últimas décadas vem se difundindo a produção deplantas de milho geneticamente modificadas que expressam proteínas com ação inseticida de forma constitutiva (milho Bt). Com o crescente uso de cultivares de milho transgênico com o gene Bt (Bacillus thuringiensis), há uma demanda por estudos que avaliem os impactos causados por essa tecnologia sobre os mecanismos de defesa das plantas e seu impacto sobre organismos não alvo, como o ácaro-rajado Tetranychus urticae Koch (Acari: Tetranychidae). Testou-se a hipótese de que plantas de milho Bt (expressando a proteína Cry 1F) seriam capazes de induzir defesas diretas a T. urticae após o ataque por esses ácaros. Assim, foram utilizadas plantas de milhos híbridos comerciais (30F35 Hx expressando a proteína Cry 1F) e seu respectivo isogênico não-Bt (controle). Nós comparamos a sobrevivência e o desempenho reprodutivo de T. urticae em plantas de ambas as linhagens que foram previamente infestadas com coespecíficos e em plantas que não foram pré-infestadas. A infestação prévia de plantas de milho Bt por T. urticae nãoapresentou diferença nos padrões de sobrevivência de formas adultas e formas jovens do coespecífico em comparação com o milho convencional. Os resultados sugerem que, o fato de o milho Bt expressar a toxina inseticida Cry 1F, não interfere na indução de defesa direta pelo ácaro-rajado T. urticae quando comparado com plantas de milho convencional.

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Transgene product expression levels are measured in genetically engineered (GE) crops containing single transformation events and the measured expression levels are then utilized in food, feed, and environmental safety assessments as part of the requirements for de-regulation of the event. Many countries also require measurement of expression levels and safety assessments for GE breeding stacks, even though the breeding stacks are composed of single events that have been previously assessed. Transgene product expression levels were measured in tissues of maize, soybean, and cotton breeding stacks and each of their component single events. Expression levels in the breeding stacks were plotted against expression levels in the single events to quantify the ability of the single events to predict transgene product expression levels in the breeding stacks. These results indicate that transgene product expression levels in single events are a reliable indicator of expression levels in breeding stacks. Based on these results it is concluded that safety assessments for breeding stacks can be conducted using transgene product expression levels from single events.

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Over the last years, the cotton (Gossypium hirsutum L.) crop in Brazil has been substantially modified by a large-scale introduction of biotechnologically-based resources. In this work, a general review on the technical principles and the current status regarding transgenic traits developed for cotton is presented. The use of transgenic cotton, which contains genes isolated from other species, has been increasingly frequent, occupying more than 80% of the crop production area in Brazil in 2017. The development of transgenic cotton is costly and time-consuming, and is concentrated in a few owner groups. Current generations of Bt protoxins isolated from Bacillus thuringiensis (“Cry” and “Vip” proteins) for control of lepidopteran insects and genes conferring tolerance to glyphosate (cp4epsps and 2mepsps) and ammonium glufosinate (pat and bar) are included as products commercially available for growers. Events for tolerance to the herbicides 2,4-D and dicamba, although already developed, require regulatory authorizations in Brazil, and, probably, will be available for commercialization in the coming years. The combination of several transgenic traits (stacked-traits)within an individual genotype is an increasing tendency for new transgenic cultivars to be launched. More recently, promising studies involving transgenic plants have been conducted to obtain resistance to diseases, tolerance to abiotic stresses, and improvements in fiber and seed properties, which may result in release of new traits in the future.

A cultura do algodoeiro (Gossypium hirsutum L.) tem sofrido importantes modificações nos últimos anos no Brasil devido à introdução em larga de escala de recursos provenientes de biotecnologia. Neste trabalho é apresentada uma revisão geral sobre os princípios técnicos e o status atual relacionados a eventos transgênicos desenvolvidos para o algodoeiro. A utilização de algodoeiro transgênico, que contém genes isolados de outras espécies, tem sido cada vez mais frequente, ocupando mais de 80% das áreas destinadas à cultura no Brasil no ano de 2017. O desenvolvimento de variedades transgênicas é um processo demorado e de custo elevado, e está concentrado em poucos grupos detentores. Entre produtos comercialmente disponíveis aos produtores incluem-se gerações atuais de protoxinas Bt isoladas de Bacillus thuringiensis (proteínas “Cry” e “Vip”) para controle de insetos lepidópteros e genes que conferem tolerância aos herbicidas glifosato (cp4epsps e 2mepsps) e glufosinato de amônio (pat e bar). Eventos de tolerância aos herbicidas 2,4-D e dicamba, embora já tenham sido desenvolvidos, necessitam de autorizações regulatórias no Brasil e devem estar disponíveis para comercialização nos próximos anos. A combinação de diversos produtos transgênicos em um mesmo genótipo (produtos piramidados) é uma tendência crescente para os próximos cultivares a serem lançados. Mais recentemente, foram realizados estudos promissores envolvendo transgenia para obtenção de resistência a doenças, tolerância a estresses abióticos e melhorias em propriedades da fibra e da semente, os quais podem resultar no fornecimento de novos eventos futuramente.

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