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.

Trichothecene Genotype Profiling of Wheat Fusarium graminearum Species Complex in Paraguay.

Paraguay is a non-traditional wheat-producing country in one of the warmest regions in South America. Fusarium Head Blight (FHB) is a critical disease affecting this crop, caused by the Fusarium graminearum species complex (FGSC). A variety of these species produce trichothecenes, including deoxynivalenol (DON) and its acetylated forms (3-ADON and 15-ADON) or nivalenol (NIV). This study characterized the phylogenetic relationships, and chemotype diversity of 28 strains within FGSC collected from wheat fields across different country regions. Phylogenetic analysis based on the sequence of elongation factor-1α gene (EF-1α) from 28 strains revealed the presence of four species in the FGSC: F. graminearum sensu stricto, F. asiaticum, F. meridionale and F. cortaderiae. Ten strains selected for further analysis revealed that all F. graminearum strains were 15-ADON chemotype, while the two strains of F. meridionale and one strain of F. asiaticum were NIV chemotype. Thus, the 15-ADON chemotype of F. graminearum sensu stricto was predominant within the Fusarium strains isolated in the country. This work is the first report of phylogenetic relationships and chemotype diversity among Fusarium strains which will help understand the population diversity of this pathogen in Paraguay.

Perception of genetically engineered crops in Paraguay.

Paraguay is integrated into the world mainly through its agricultural activity. The population's perception of genetically engineered crops is relevant to design communication strategies that convey the advantages and limitations of the various technologies used in the country. We aimed to know the perception of the population of four Departments of the country where such crops are grown through a survey, which revealed a low level of knowledge about genetically engineered crops in general, and specifically about the effects of genetically engineered crops on production, nutrition, and the environment. Respondents expressed a willingness to receive information on genetically engineered crops, in particular from the National Government and the Health Sector.

Presence of Aflatoxin M1 in Commercial Milk in Paraguay.

ABSTRACT: The presence of aflatoxin M1 (AFM1) in milk is a public health concern because milk is a significant part of human diets worldwide. In economies where AFM1 monitoring is low or nonexistent, the possibility of AFM1 contamination might be increased. Our study was conducted to detect and quantify AFM1 in fluid milk and milk drinks of various brands, fat concentrations, packages, and heat treatments sold in the Metropolitan Area of Asunción, Paraguay. Eighty samples were collected from supermarkets in the Metropolitan Area of Asunción following a nonprobability sampling method. An enzyme-linked immunosorbent assay for AFM1 (25 to 500 ppt) was used to quantify the toxin, and results were analyzed with nonparametric methods. All samples were positive values for AFM1 (above the detection limit of 25 ng/kg); 85% of the samples had 30 to 50 ng/kg, and 15% had >500 ng/kg. No significant difference in AFM1 concentration was found based on fat concentration, heat treatment, or type of packaging of these milk products; however, significant differences were found between brands.

Presencia de aflatoxina M1 en fórmulas lácteas infantiles comercializadas en el área metropolitana a Asunción, Paraguay

RESUMEN Introducción: La aflatoxina M1 (AFM1) es un metabolito tóxico derivado de la aflatoxina B. Su ingestión en lactantes se ha relacionado con retraso en el crecimiento, aumento de susceptibilidad a enfermedades infecciosas, reducción de la eficiencia en la inmunización y cirrosis. En Paraguay se recomienda lactancia exclusiva hasta los 6 meses, sin embargo se comercializan diferentes marcas de fórmulas infantiles dirigidas a lactantes menores de 6 meses. Objetivo: Detectar y cuantificar la presencia de AFM1 en fórmulas para lactantes comercializadas en el Área Metropolitana. Materiales y Métodos: Se adquirieron fórmulas fluidas (n=18) y en polvo (n=91) para lactantes de 0 a 12 meses de farmacias y supermercados del Área Metropolitana de Asunción y fueron analizados mediante el ensayo de inmunoafinidad ligado a enzimas (ELISA). Resultados: 9,75% (0 a 6 meses) y 2% (6 a 12 meses) de las fórmulas lácteas en polvo y 100% de las fórmulas fluidas resultaron positivas para AFM1. La mediana de contenido de AFM1 en formulas en polvo fue de 1820 ng/kg y 510 ng/kg en las marcas A y B. En las fórmulas líquidas fue de 31,8 ng/kg y 33,6 ng/kg para las dos marcas analizadas respectivamente, p=0,0001. Conclusiones: Se detectó AFM1 en todas las fórmulas líquidas analizadas, y en el 2 y 9,7% de las fórmulas en polvo de las marcas Ay B respectivamente Los niveles de AFM1 fueron mayores en las fórmulas en polvo.

ABSTRACT Introduction: Aflatoxin M1 (AFM1) is a toxic metabolite derived from aflatoxin B. Its ingestion in infants has been related to growth retardation, increased susceptibility to infectious diseases, reduced immunization efficiency, and cirrhosis. In Paraguay, exclusive breastfeeding is recommended up to 6 months of age, however, different brands of infant formulas targeted at this age range are marketed. Objective: To detect and quantify the presence of AFM1 in infant formulas marketed in the Metropolitan Area. Materials and Methods: Fluid (n = 18) and powder (n = 91) formulas for infants aged 0 to 12 months were purchased from pharmacies and supermarkets in the Metropolitan Area of Asunción and were analyzed using the enzyme-linked immunoaffinity assay (ELISA). Results: 9.75% (0 to 6 months) and 2% (6 to 12 months) of the powdered milk formulas and 100% of the fluid formulas were positive for AFM1. The median content of AFM1 in powder formulas was 1820 ng/kg and 510 ng/kg in brands A and B, while in liquid formulas it was 31.8 ng/kg and 33.6 ng/kg for the two brands analyzed respectively (p = 0.0001). Conclusions: AFM1 was detected in all the liquid formulas analyzed, and in 2 and 9.7% of the powder formulas of brands A and B, respectively. The levels of AFM1 were higher in the powder formulas.

Paraguay's Path Toward the Simplification of Procedures in the Approval of GE Crops.

Agricultural biotechnology was first regulated in Paraguay in 1997. The first update to the country's regulatory framework came in 2012, motivated by the need to keep up with current technologies. As part of this process, in late 2012, the Paraguayan Ministry of Agriculture (MAG) joined the Partnership for Biosafety Risk Assessment and Regulation, led by ILSI Research Foundation. The purpose of the program was the development of capacity building activities. As a result, the regulatory authorities in Paraguay incorporated the problem formulation approach to environmental risk assessment into their regulatory processes, leading to improved efficiency, with more timely decisions. Shifting to a problem formulation-based decision-making system was not straightforward, since practice and experience are always required to make professional risk assessors. Despite the continuity of approvals, there was a lag in the response time reflected in the number of events approved. During 2019, a simplified approval procedure for events that have been assessed by sound and experienced regulatory systems was introduced. Acceptance of third-country assessments can allow regulatory systems to make better use of their human, financial, and institutional resources, and stimulate inter-agency cooperation. In this work we aim to present the recent evolution of the regulatory system in Paraguay toward the establishment of a simplified procedure for GE crops that have been already assessed by sound and experienced regulatory systems, taking into account several scientific criteria. Concepts such as the familiarity, history of safe use, substantial equivalence, transportability, problem formulation, and the use of the consensus documents, developed by Organization for Economic Co-operation and Development (OECD), Food and Agriculture Organization of the United Nations (FAO), World Health Organization (WHO) and other institutions, favors the acceptance of decision documents issued by third countries. This requires the commitment of governments to support the stability of the institutions responsible for the regulatory implementation and also encourages countries to put work into the preparation and publication of decision documents, which are the basis for the commercialization of GE events.

Sistema CRISPR/Cas: Edición genómica de precisión / CRISPR/Cas system: precision genome editing

La función original de los sistemas CRISPR/Cas es destruir el DNA de virus bacterianos. Este sistema ha evolucionado para identificar y cortar secuencias de diferentes DNA de virus de DNA evitando la infección. En la célula, está compuesto de genes Cas que producen nucleasas guiadas por RNA capaces de cortar el DNA. Si el RNA guía encuentra DNA de un virus con el que se puede emparejar, recluta a la nucleasa Cas9 que lo corta. Este sistema es utilizado in vitro para editar genes basándose en la producción de rupturas de doble cadena y su posterior reparación. Actualmente existen varias plataformas para el diseño de RNAs guía, aunque también es posible realizarlo de forma manual. Los componentes del sistema son entregados a la célula mediante un plásmido o una ribonucleoproteína. En esta revisión nos centraremos en la función original de CRISPR/Cas en procariotas y en cómo los investigadores la han modificado para proporcionar nuevas técnicas de edición de genomas. Discutiremos sobre las ventajas de esta nueva técnica, las formas en que podemos utilizarla y algunas de las limitaciones que aún encontramos en su aplicación

The original function of CRISPR/Cas systems is to destroy the DNA of bacterial viruses. This system has evolved to identify sequences of different DNA viruses and cut them in order to avoid infection. In the cell, the system is made up of Cas genes which produce RNA-guided nucleases capable of cutting DNA. If the guide RNA finds viral DNA with which it can pair up, it recruits the Cas9 nuclease to cut it. This system is used in vitro for gene edition, relying on the production of double-strand breaks and their subsequent repair. Currently, there are several platforms for the design of the guide RNA, and it is also possible to design it manually. The components of the system can be delivered to the cell through a plasmid or through a ribonucleoprotein. In this review we will focus on the original function of CRISPR/Cas in prokaryotes, and in how researchers have modified it in order to provide new genome editing techniques. We will discuss the advantages of this new technique, the ways in which it can be used, and some of the limitations found in its application

Occurrence of Deoxynivalenol and Ochratoxin A in Beers and Wines Commercialized in Paraguay.

Alcoholic beverages can be contaminated with mycotoxins. Ochratoxin A (OTA) is the most frequently detected mycotoxinin wine and is produced by several species of Aspergillus. This mycotoxin is nephrotoxic and carcinogenic. In beer, the most commonly identified mycotoxin is deoxynivalenol (DON). Ingestion of food contaminated with DON has been associated with adverse gastrointestinal effects. Despite the harmful effects of mycotoxins on health, there are no regulations regarding their limits in alcoholic beverages in Paraguay. Here we determine the presence of OTA and DON in wine and beer, respectively. Four commercial brands of wine and twenty-nine brands of craft and industrial beerwere tested by the Agra quant ELISA method. One brand of wine was positive for OTA and seven brands of beer (one of them craft) were positive for DON. The values found for both toxins are below the recommended maximum intake proposed by international standards. Giving the high consumption of these products in the country, regulations and monitoring systems mustbe established to check the maximum levels of mycotoxins allowed in alcoholic beverages.

Presencia de micotoxinas en preparados y colados comerciales para lactantes en el área metropolitana de Asunción, Paraguay

Introducción: Las micotoxicosis son enfermedades producidas por micotoxinas, metabolitos secundarios tóxicos producidos por hongos filamentosos. Los lactantes son especialmente susceptibles a este tipo de toxinas debido a la inmadurez anatómica y funcional de sus sistemas digestivo e inmune, lo que se refleja en la relación entre la cantidad de alimento ingerida y su peso. Objetivo: Determinar la presencia de micotoxinas en alimentos para lactantes comercializados en farmacias y supermercados del Área Metropolitana. Materiales y métodos: Se colectaron al azar 66 unidades de productos de seis marcas diferentes de preparados y colados comerciales importados, dulces y salados, de farmacias y supermercados del Área Metropolitana. Posteriormente, fueron analizados mediante el ensayo de inmunoafinidad ligado a enzimas (ELISA). Se realizó el análisis de varianza y la posterior comparación de medias de las concentraciones de micotoxinas mediante la prueba de Tukey (IC= 95%), con el estadístico InfoStat®. Resultados: Las micotoxinas prevalentes fueron aflatoxinas (AF) y Toxina T2, que se presentaron en 39% de las unidades muestrales analizadas, tanto en preparados como en colados. En tercer orden de importancia se encuentra ocratoxina A (OTA), detectada en 18% de las mismas. En cuarto lugar, deoxinivalenol (DON) se detectó en 4% los productos. Se presentaron diferencias significativas entre los preparados y los colados, siendo los colados los que en media presentaron niveles más altos de concentraciones de todas las micotoxinas estudiadas. Conclusiones: Se constataron niveles variables de AF, OTA, T2 y DON en los alimentos para lactantes comercializados en el Área Metropolitana. Los colados presentaron concentraciones más elevadas de micotoxinas en media en todos los productos analizados. Tanto AF como OTA superaron los límites máximos permitidos por las normas internacionales.

Introduction: Mycotoxicoses are diseases caused by mycotoxins, secondary toxic metabolites produced by filamentous fungi. Infants are especially susceptible to this type of toxins due to the anatomical and functional immaturity of their digestive and immune systems, which is related to the amount of food eaten and their weight. Objective: To determine the presence of mycotoxins in foods for infants sold in pharmacies and supermarkets in the Metropolitan Area. Materials and methods: 66 units of products from six different brands of imported commercial sweet and salty preparations and strained foods from pharmacies and supermarkets in the Metropolitan Area were randomly collected. Subsequently, they were analyzed by the enzyme-linked immunoaffinity test (ELISA). The variance analysis and the subsequent comparison of means of mycotoxin concentrations were performed using the Tukey test (95% CI), with the InfoStat® statistic. Results: The prevalent mycotoxins were aflatoxins (AF) and T-2 Toxin, which were present in 39% of the sample units analyzed, both in preparations and in strains. In third order of importance we detected Ochratoxin A (OTA) in 18% of the units. Fourth, deoxinivalenol (DON) products were detected in 4%. There were significant differences between the preparations and the strains, with the strains having the highest concentration levels of all the mycotoxins studied. Conclusions: Variable levels of AF, OTA, T-2 and DON were found in infant foods marketed in the Metropolitan Area. The strains showed a higher average concentrations of mycotoxins in all the products analyzed. Both AF and OTA exceeded the maximum limits allowed by international standards.

Capacities for the Risk Assessment of GMOs: Challenges to Build Sustainable Systems.

The need for functional risk assessment bodies in general, and in the biosafety field in particular, demands continued efforts and commitment from regulatory agencies, if results that are sustainable in time are to be achieved. The lack of formal processes that ensure continuity in the application of state of the art scientific criteria, the high rotation in some cases or the lack of experienced professionals, in others, is a challenge to be addressed. Capacity building initiatives with different approaches and degrees of success have been implemented in many countries over the years, supported by diverse governmental and non-governmental organizations. This document summarizes some capacity building experiences in developing countries and concludes that risk assessors taking ownership and regulatory authorities fully committed to developing and retaining highly qualified bodies are a sine qua non to achieve sustainable systems. To this end, it is essential to implement "in-house" continuing education mechanisms supported by external experts and organizations, and inter-institutional cooperation. It has to be noted that these recommendations could only be realized if policy makers understand and appreciate the value of professional, independent regulatory bodies.