Genome editing revolutionized agriculture by improving crop productivity, disease resistance, and adaptation to adverse climatic conditions. However, it has faced significant regulatory challenges due to divergent regulations between regions. Although Europe classified these organisms as genetically modified organisms, Africa, Asia, and Latin America implemented more flexible regulatory frameworks, which encouraged innovation and the participation of small companies. These differences could generate high costs, delays in commercialization, and difficulties in product traceability, affecting research and development decisions. This article analyzes the main regulatory challenges and their impact on global trade, proposing strategies for regulatory harmonization to promote transparency, reduce trade barriers, and maximize the potential of these technologies in the face of global challenges such as food security and climate change.

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.

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.

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.

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.

The presence of AFM 1 in milk is a public health concern, since milk is a significant part of human diets across nations. In economies where monitoring is low or non-existent, the possibility of contamination with AFM 1 might be increased. Our study aimed to detect and quantify the concentration of AFM 1 in fluid milk and milk drink of different brands, fat contents, packages and, heat treatments sold in the Metropolitan Area of Asunción. 80 samples were collected following a non-probability sampling method; acquired from supermarkets from the Metropolitan Area of Asunción. To quantify AFM 1 , the AgraQuant® ELISA Aflatoxin M 1 25 - 500 ppt was used. Non-parametric analysis was performed. All samples presented positive values for the detection limit (25 ng/kg); 85% of the samples showed values between 30 to 50 ng/kg, and 15% showed values over 500 ng/kg. There was no significant difference in the content of AFM 1 between fat contents, heat treatments, or types of packaging. However, brands differed significantly.