Paraguay's approach to biotechnology governance: a comprehensive guide.

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.

Specificity Testing for NGT PCR-Based Detection Methods in the Context of the EU GMO Regulations.

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.

Bioremediation, drought tolerance and biofortification in biotechnological uses

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)

Reflexões sobre a proposta de modificação da regulamentação de rotulagem de alimentos transgênicos no Brasil / Reflections on proposed modifications to the regulation of genetically modified food labeling in Brazil

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.

Attitudes of the Ecuadorian University Community Toward Genetically Modified Organisms.

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.

Evidence of Food Safety in Relation to Cry Proteins in Genetically Modified Foods / Evidencias sobre seguridad alimentaria con relación a Cry proteínas en alimentos transgénicos

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.

Production of transgenic cattle by somatic cell nuclear transfer (SCNT) with the human granulocyte colony-stimulation factor (hG-CSF).

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.

Direct defense elicited by tetranychus urticae koch (acari: tetranychidae) in bt maize plants / Defesa direta elicitada por Tetranychus urticae koch (Acari: Tetranychidae) em milho Bt

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.

Transgene-product expression levels in genetically engineered breeding stacks are equivalent to those of the single events.

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.

Transgenic traits in the cotton crop in Brazil: a review / Tecnologias transgênicas na cultura do algodoeiro no Brasil: revisão

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.(AU)

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.(AU)

Transgenic traits in the cotton crop in Brazil: a review / Tecnologias transgênicas na cultura do algodoeiro no Brasil: revisão

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.

Transgene flow in Mexican maize revisited: Socio-biological analysis across two contrasting farmer communities and seed management systems.

The flow of transgenes into landraces and wild relatives is an important biosafety concern. The case of transgene flow into local maize varieties in Mexico (the center of origin of maize) has been intensively debated over the past 15 years, including legal, political, and environmental disputes fanned by the existence of a significant scientific controversy over the methods used for the detection of transgenes. The use of diverse approaches and a lack of harmonized methods specific to the detection and monitoring of transgenes in landraces have generated both positive and negative results regarding contamination of Mexican maize with genetically modified material over the years. In this paper, we revisit the case of transgene contamination in Mexican maize and present a novel research approach based on socio-biological analysis of contrasting communities and seed management systems. Two communities were used to investigate how different social and biological factors can affect transgene flow and impact transgene spread in Mexico. Our results show the presence of transgenes in one community and thus support the position that transgenes are highly likely to be present in Mexican maize landraces. However, our work also demonstrates that the extent and frequency with which transgenes can be found will significantly depend on the societal characteristics and seed management systems of the local communities. Therefore, we argue that future analysis of transgene presence should include social research on the seed management practices in the sampling area so that more robust and comprehensive understandings and conclusions can be drawn.

Phytophagous mites on genetically modified maize with Bacillus thuringiensis genes / Ácaros fitófagos em milho geneticamente modificado com genes de Bacillus thuringiensis

The study of non-target organisms such as mites, can provide information about the possible effects of transgenic maize cultivars on the arthropod community. This study aimed to evaluate the abundance of phytophagous mites in the area of Bt maize and evaluate the instantaneous population growth rate, and food preference of phytophagous mites on Bt maize. We registered the species occurrence and the number of adult mite individuals on four maize cultivars, one non-Bt 30F35, and three containing the proteins Cry1Ab (30F35 Yg), Cry1F (30F35 Hx) and Vip3a (Impacto Viptera). Cry proteins disrupt the midgut epithelium of insect pests. The food preference and instantaneous population growth rate (ri) were evaluated using the two-spotted spider mite Tetranychus urticae as model. The species Catarhinus tricholaenae and Aceria zeala were recorded. The Bt maize cultivars did not significantly affect the average number of C. tricholaenae and A. zeala mites compared to conventional cultivar. The population growth rates of T. urticae were similar for the different maize cultivars. T. urticae showed no preference between the leaf of Bt or conventional cultivars. Bt maize did not affect the abundance of species in phytophagous mite.(AU)

O estudo de organismos não-alvo, tais como ácaros, pode fornecer informações sobre os possíveis efeitos de cultivares de milho transgênico na comunidade de artrópodos. Este estudo teve como objetivo avaliar a abundância de ácaros fitófagos na área de milho Bt e avaliar a taxa de crescimento populacional instantânea e preferência alimentar de ácaros fitófagos em milho Bt. Registramos a ocorrência de espécies e número de indivíduos adultos de ácaros em quatro cultivares de milho, um não-Bt 30F35, e três contendo a proteína Cry1Ab (30F35 Yg), Cry1F (30F35 Hx) e VIP3A (Impacto Viptera). A preferência alimentar e taxa instantânea de crescimento populacional foram avaliadas utilizando fêmeas adultas do ácaro-rajado Tetranychus urticae. As espécies Catarhinus tricholaenae e Aceria zeala foram registradas. As cultivares de milho Bt não afetaram significativamente o número médio de ácaros C. tricholaenae e A. zeala em relação ao cultivar convencional. As taxas de crescimento populacional de T. urticae foram similares para os diferentes cultivares. T. urticae não mostrou preferência entre a folha de milho Bt ou cultivares convencionais. Sugere-se, então, que o milho Bt não afeta a abundância de espécies, preferência alimentar e taxa de crescimento de ácaros fitófagos.(AU)

Cultivos genéticamente modificados: ¿son un riesgo para el ambiente y para la salud? / Are genetically modified cultures risky to environment and health?

La utilización de cultivos genéticamente modificados ha tenido en nuestro país y en el mundo una amplia acogida por parte de los productores agrícolas, pues ha significado una disminución de costos y un aumento de la producción. Uno de los temas más importantes del debate sobre la biotecnología aplicada a la agricultura se relaciona con los posibles riesgos sobre la salud humana y el ambiente que podrían generar los organismos vegetales genéticamente modificados (OVGM). Esta cuestión es la que origina las cuestiones regulativas, éticas y sociales actualmente en discusión

Genetically modified cultures have been well received by agricultural producers in our country and all round the world, because they generate greater benefits, less costs and increased production. Among the most important debated points over biotechnological application to agriculture is the possibility of risk that modified vegetable species may produce to human health. This question had generated multiple ethical, social and regulative worries

A utilização de cultivos geneticamente modificados tem atingido em nosso país e no mundo toda uma ampla acolhida da parte dos produtores agrícolas, pela diminuição dos custos e o acréscimo da produção. Um assunto dos mais importantes no debate sobre a biotecnologia aplicada à pecuária relaciona-se com os possíveis riscos sobre a saúde humana e o meio-ambiente que poderiam gerar os organismos vegetais genéticamente modificados (OVGM). Esta questão orienta aspectos de regulamentação, éticos e sociais que atualmente se discutem

Phytophagous mites on genetically modified maize with Bacillus thuringiensis genes / Ácaros fitófagos em milho geneticamente modificado com genes de Bacillus thuringiensis

The study of non-target organisms such as mites, can provide information about the possible effects of transgenic maize cultivars on the arthropod community. This study aimed to evaluate the abundance of phytophagous mites in the area of Bt maize and evaluate the instantaneous population growth rate, and food preference of phytophagous mites on Bt maize. We registered the species occurrence and the number of adult mite individuals on four maize cultivars, one non-Bt 30F35, and three containing the proteins Cry1Ab (30F35 Yg), Cry1F (30F35 Hx) and Vip3a (Impacto Viptera). Cry proteins disrupt the midgut epithelium of insect pests. The food preference and instantaneous population growth rate (ri) were evaluated using the two-spotted spider mite Tetranychus urticae as model. The species Catarhinus tricholaenae and Aceria zeala were recorded. The Bt maize cultivars did not significantly affect the average number of C. tricholaenae and A. zeala mites compared to conventional cultivar. The population growth rates of T. urticae were similar for the different maize cultivars. T. urticae showed no preference between the leaf of Bt or conventional cultivars. Bt maize did not affect the abundance of species in phytophagous mite.

O estudo de organismos não-alvo, tais como ácaros, pode fornecer informações sobre os possíveis efeitos de cultivares de milho transgênico na comunidade de artrópodos. Este estudo teve como objetivo avaliar a abundância de ácaros fitófagos na área de milho Bt e avaliar a taxa de crescimento populacional instantânea e preferência alimentar de ácaros fitófagos em milho Bt. Registramos a ocorrência de espécies e número de indivíduos adultos de ácaros em quatro cultivares de milho, um não-Bt 30F35, e três contendo a proteína Cry1Ab (30F35 Yg), Cry1F (30F35 Hx) e VIP3A (Impacto Viptera). A preferência alimentar e taxa instantânea de crescimento populacional foram avaliadas utilizando fêmeas adultas do ácaro-rajado Tetranychus urticae. As espécies Catarhinus tricholaenae e Aceria zeala foram registradas. As cultivares de milho Bt não afetaram significativamente o número médio de ácaros C. tricholaenae e A. zeala em relação ao cultivar convencional. As taxas de crescimento populacional de T. urticae foram similares para os diferentes cultivares. T. urticae não mostrou preferência entre a folha de milho Bt ou cultivares convencionais. Sugere-se, então, que o milho Bt não afeta a abundância de espécies, preferência alimentar e taxa de crescimento de ácaros fitófagos.

Phytophagous mites on genetically modified maize with Bacillus thuringiensis genes / Ácaros fitófagos em milho geneticamente modificado com genes de Bacillus thuringiensis

ABSTRACT: The study of non-target organisms such as mites, can provide information about the possible effects of transgenic maize cultivars on the arthropod community. This study aimed to evaluate the abundance of phytophagous mites in the area of Bt maize and evaluate the instantaneous population growth rate, and food preference of phytophagous mites on Bt maize. We registered the species occurrence and the number of adult mite individuals on four maize cultivars, one non-Bt 30F35, and three containing the proteins Cry1Ab (30F35 Yg), Cry1F (30F35 Hx) and Vip3a (Impacto Viptera). Cry proteins disrupt the midgut epithelium of insect pests. The food preference and instantaneous population growth rate (ri) were evaluated using the two-spotted spider mite Tetranychus urticae as model. The species Catarhinus tricholaenae and Aceria zeala were recorded. The Bt maize cultivars did not significantly affect the average number of C. tricholaenae and A. zeala mites compared to conventional cultivar. The population growth rates of T. urticae were similar for the different maize cultivars. T. urticae showed no preference between the leaf of Bt or conventional cultivars. Bt maize did not affect the abundance of species in phytophagous mite.

RESUMO: O estudo de organismos não-alvo, tais como ácaros, pode fornecer informações sobre os possíveis efeitos de cultivares de milho transgênico na comunidade de artrópodos. Este estudo teve como objetivo avaliar a abundância de ácaros fitófagos na área de milho Bt e avaliar a taxa de crescimento populacional instantânea e preferência alimentar de ácaros fitófagos em milho Bt. Registramos a ocorrência de espécies e número de indivíduos adultos de ácaros em quatro cultivares de milho, um não-Bt 30F35, e três contendo a proteína Cry1Ab (30F35 Yg), Cry1F (30F35 Hx) e VIP3A (Impacto Viptera). A preferência alimentar e taxa instantânea de crescimento populacional foram avaliadas utilizando fêmeas adultas do ácaro-rajado Tetranychus urticae. As espécies Catarhinus tricholaenae e Aceria zeala foram registradas. As cultivares de milho Bt não afetaram significativamente o número médio de ácaros C. tricholaenae e A. zeala em relação ao cultivar convencional. As taxas de crescimento populacional de T. urticae foram similares para os diferentes cultivares. T. urticae não mostrou preferência entre a folha de milho Bt ou cultivares convencionais. Sugere-se, então, que o milho Bt não afeta a abundância de espécies, preferência alimentar e taxa de crescimento de ácaros fitófagos.

Biological characteristics of black armyworm Spodoptera cosmioides on genetically modified soybean and corn crops that express insecticide Cry proteins

ABSTRACT This study aimed to evaluate the development and reproduction of the black armyworm, Spodoptera cosmioides when larvae fed on leaves of Bt-corn hybrids, expressing a single Cry1F and also Cry1F, Cry1A.105 and Cry2Ab2 in pyramided corn and their non-Bt-isoline (hybrid 2B688), as well as on leaves of two soybean isolines expressing the Cry1Ac protein and its non-Bt isoline (A5547-227). We also assessed the effect of these Bt and non-Bt plants on the leaf consumption rate of S. cosmioides larvae. This pest was unable to develop when fed on any of the corn isolines (Bt and non-Bt). When both 1st and 3rd instar larvae were fed on corn leaf, mortality was 100% in both Bt and non-Bt corn. In contrast, when corn leaves were offered to 5th instar larvae, there were survivors. Defoliation and leaf consumption was higher with non-Bt corn than with both of the Bt corn isolines. There was no negative effect of Bt soybean leaves on the development and reproduction of S. cosmioides with respect to all evaluated parameters. Our study indicates that both Bt and non-Bt corn adversely affect the development of S. cosmioides while Bt soybean did not affect its biology, suggesting that this lepidopteran has major potential to become an important pest in Bt soybean crops.

The transgenic animal platform for biopharmaceutical production.

The recombinant production of therapeutic proteins for human diseases is currently the largest source of innovation in the pharmaceutical industry. The market growth has been the driving force on efforts for the development of new therapeutic proteins, in which transgenesis emerges as key component. The use of the transgenic animal platform offers attractive possibilities, residing on the low production costs allied to high productivity and quality of the recombinant proteins. Although many strategies have evolved over the past decades for the generation of transgenic founders, transgenesis in livestock animals generally faces some challenges, mainly due to random transgene integration and control over transgene copy number. But new developments in gene editing with CRISPR/Cas system promises to revolutionize the field for its simplicity and high efficiency. In addition, for the final approval of any given recombinant protein for animal or human use, the production and characterization of bioreactor founders and expression patterns and functionality of the proteins are technical part of the process, which also requires regulatory and administrative decisions, with a large emphasis on biosafety. The approval of two mammary gland-derived recombinant proteins for commercial and clinical use has boosted the interest for more efficient, safer and economic ways to generate transgenic founders to meet the increasing demand for biomedical proteins worldwide.

Estudo proteômico de variedades de milho ( Zea mays L. ) obtidas por melhoramento clássico e por recombinação genética / Proteomic study of maize ( Zea mays L. ) varieties obtained by classical breeding and genetic recombination.

O melhoramento genético clássico de sementes milho (Zea mays L.) permitiu desenvolver inúmeras variedades, incluindo o milho com qualidade proteica melhorada (Quality Protein Maize, QPM), que visava aumentar os teores proteicos e as propriedades nutricionais. Por outro lado, novas variedades comerciais foram obtidas por vegetais geneticamente modificados (GM), com foco em parâmetros agronômicos. Em ambos os casos, a segurança dessas variedades para uso como alimento é uma das principais preocupações dos desenvolvedores e dos órgãos de regulamentação. A Equivalência Substancial é a base do sistema de avaliação da segurança de culturas geneticamente modificadas, no entanto alterações na expressão de proteínas não são devidamente analisadas e esclarecidas. As abordagens proteômicas complementam as técnicas de avaliação de biossegurança para alimentos GM, bem como permitem investigar possíveis efeitos indesejáveis derivados do melhoramento clássico. Os objetivos do presente estudo foram caracterizar e comparar os perfis proteicos de variedades de milhos convencionais melhorados (QPM) e geneticamente modificados (GMs), contra suas respectivas linhas convencionais utilizando técnicas proteômicas como eletroforese bidimensional (2-DE) e bottom up shotgun (gel-free). Num primeiro estudo, foram utilizadas três amostras de milho, sendo duas variedades convencionais com QPM (QP1 e QP2) e uma variedade convencional normal (CN). No segundo estudo, foram analisadas duas cultivares de milho GM (GM1 e GM2) e seus respectivos convencionais genitores (CG1 e CG2). As composições químicas de todas as amostras também foram avaliadas quanto a Equivalência Substancial. O extrato bruto proteico foi submetido à análise de eletroforese unidimensional (1-DE), bidimensional (2-DE) e bottom up shotgun (gel-free). As imagens dos mapas proteicos foram analisadas pelo software Image Master 2D Platinum 7.0 (GE). Os spots diferencialmente expressos e selecionados foram sequenciados por MS. Pela composição química das principais frações das amostras de milho foi possível identificar a equivalência substancial entre as amostras convencionais e GMs, bem como QPMs e sua convencional dentro das faixas de variabilidade esperadas da espécie. Nos géis 1-DE foram observadas bandas proteicas com perfis similares entre os grupos de amostras avaliadas para ambos estudos. Nas imagens dos géis 2-DE não houveram alterações extremas entre as amostras de milhos GMs e seus respectivos convencionais genitores (CGs), mas apenas diferenças na intensidade dos spots proteicos. As variedades QPMs e CN apresentaram diferenças devido à distribuição dos spots. Os mapas proteicos das amostras CG1 x GM1 e CG2 x GM2 apresentaram maior semelhança com porcentagens de matchings superiores a 70 %, enquanto as porcentagens de matchings entre variedades diferentes (QPMs e CN) foram menores. No total foram identificadas 219 proteínas das amostras CGs x GMs e QPMs x CN, classificadas quanto aos seus processos biológicos e função molecular. Em conclusão, foram encontradas diferenças entre os cultivares GMs e CGs, indicando uma variação normal entre variedades de milho, que não comprometem a segurança alimentar das amostras estudadas. Quanto às amostras com QPM e CN as diferenças encontradas são devido à sua distância nas linhagens ou germoplasma

The classic genetic breeding of corn seeds (Zea mays) has enabled the development of many varieties, including corn with improved protein quality (Quality Protein Maize, QPM), which aimed to increase protein levels and nutritional properties. On the other hand, new commercial varieties have been obtained out of genetically modified (GM) vegetables, with a focus in agronomic parameters. In both cases, the safety of these varieties for food use is one of the main concerns for the developers and for the regulatory agencies. Substantial Equivalence is the basis of the safety evaluation system for genetically modified crops, however, alterations in the protein expressions are not been properly analyzed and clarified. The protein approaches complement the techniques of biosafety evaluation for GM foods, as well as allow for possible undesirable effects derived from classic improvement to be investigated. The goals of the current studies were to characterize and compare the protein profiles of the different varieties of conventionally improved (QPM) and genetically modified (GM) corn, against their respective conventional lines using proteomic techniques, such as, two-dimensional electrophoresis (2-DE), bottom up shotgun (gel-free) and masses spectrometry (MS). In a first instance of the study, three samples of corn were used, two of conventional varieties with QPM (QP1 and QP2) and one conventional normal variety (CN). In a second instance of the study, two cultures of GM corn (GM1 and GM2) were analyzed and their respective conventional genitors (CG1 and CG2). The chemical compositions of all the samples were also evaluated for their Substantial Equivalence. The protein raw extract was submitted to analysis of one-dimensional (1-DE), two-dimensional (2-DE) electrophoresis, and bottom up shotgun (gel-free). The protein image maps were analyzed by the Image Master 2D Platinum 7.0 (GE) software. The spots which were expressed and selected differentially were sequenced by MS. By the chemical composition of the main fractions of the samples of corn, it was possible to identify the substantial equivalence between the conventional samples and GMs, likewise with OPMs and their conventional in the ranges of variability which were expected for the species. On the 1-DE gel, it was observed protein bands with similar profiles amongst the groups of evaluated samples for both studies. In the images of the 2-DE gel, there were no alterations between the GM corn and their respective conventional genitors (CGs), but only differences in intensity of the protein spots. The OPM and CN varieties presented differences due to the distribution of the spots. The protein maps of samples CG1 vs. GM1 and CG2 vs. GM2 presented greater similarities with the percentages of matchings superior to 70%, while the percentage of matchings among different varieties (QPMs and CN) were smaller. In total, there were 219 proteins identified in the samples CGs vs. GMs and QPMs vs. CN, classified by the biologic processes and molecular function. In conclusion, there were found differences between the cultures of GMs and CGs, indicating a normal variation among the corn varieties, which do not affect the food security of the studied samples. As per the samples with QPM and CN, the differences found were due to the line distances or germplasm

Regulatory framework for gene editing and other new breeding techniques (NBTs) in Argentina.

"New Breeding Techniques" (NBTs) are a group of recent innovations in plant breeding using molecular biology tools. It is becoming evident that NBTs can introduce advantageous traits for agriculture that could be commercially available very soon However, there is still a need of clarifying its regulatory status, particularly in regards to worldwide regulations on Genetically Modified Organisms (GMOs). This article reviews the meaning of the NBTs concept, performs an overall regulatory analysis of these technologies and reports the first regulation in the world that is applied to these technologies, which was issued by the Argentine Government.