Graduate certificate on risk analysis for the Agrifood sector at the University of Buenos Aires.

Argentina has an extensive experience in the biosafety assessment of transgenic crops. The regulatory framework celebrated 30 years of existence in 2021 and has pioneered the establishment of the biosafety systems in Latin America. During this period, Argentina's regulatory framework evolved to keep up with the advancements in plant and animal biotechnology and in risk assessment criteria, as new knowledge and experience was being gained. However, despite the country's agricultural tradition and experience in the adoption of innovations by the productive sector, dedicated, formal academic offerings training is lacking and this is also true for most countries in the world. Responding to this perceived need and going beyond biotechnology to include other regulated inputs used along the food production chain (chemicals, biologics, food additives, etc.), we developed a program to introduce graduates from diverse disciplines to the principles and practice of Risk Analysis (Assessment, Management and Communication) with focus on the Agrifood sector. In 2020, the School for Graduate Students of the School of Agriculture-University of Buenos Aires, approved two Certificates on Risk Analysis for the Agrifood Sector: Conceptual Bases of Risk Analysis and Methodological Tools. The first edition of the certificates was completed in December 2022 and the second one is presently ongoing. The fundaments, rationale, structure and objectives of these certificates are presented.

Market Expansion of Caffeine-Containing Products: Italian and Argentinian Yerba Mate Consumer Behavior and Health Perception.

Mate is the most consumed beverage in South America. There is interest in expanding yerba mate sales into the old and new markets by promoting its health properties and energizing effects. The research study aims to explore Argentinian and Italian purchasing and consumption behavior and perception of yerba mate. The exploration includes agro-food chain stakeholders' views, and consumers' habits, perception, knowledge of yerba mate in relation to other market positioning caffeine-containing products. Data collection includes qualitative method, such as interviews with agro-food chain stakeholders, that is producers, processors, consumers, and quantitative consumer survey. Data collection was carried out in Argentina and in Italy. Results show that in Argentina yerba mate consumption is driven by habit and tradition, and in Italy yerba mate is mostly unknown. Consumers tend to drink yerba mate in Argentina and other caffeine-containing beverages in Italy to socialize, and as source of energy. Consumers have little awareness of yerba mate antioxidant properties. Yerba mate provides the energy of coffee drinking, and the taste and pleasure of tea drinking. Italian consumers' key challenge to yerba mate drinking is the longer time it takes, compared to the usual espresso. Italians perceive it as an energetic or relaxing beverage, with a consumption experience similar to tea and infusions. There is need to update commercialization strategy of yerba mate in Italy.

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.

Argentina's Local Crop Biotechnology Developments: Why Have They Not Reached the Market Yet?

Plant biotechnology in Argentina started at the end of the 1980s, leading to the development of numerous research groups in public institutions and, a decade later, to some local private initiatives. The numerous scientific and technological capacities existing in the country allowed the early constitution in 1991 of a sound genetically modified organisms biosafety regulatory system. The first commercial approvals began in 1996, and to date, 59 events have obtained permits to be placed on the market, however, only two have been developed locally by public-private partnerships. The transgenic events developed at public institutions pursue different objectives in diverse crops. However, once these events have been developed in laboratories, it is difficult to move toward a possible commercial approval. In this work, we analyze several reasons that could explain why local developments have not reached approvals for commercialization, highlighting aspects related to the lack of strategic vision in the institutions to focus resources on projects to develop biotechnological products. Although progress has been made in generating regulatory rules adapted to research institutes (such as the regulations for biosafety greenhouses and ways of presenting applications), researchers still do not conceive regulatory science as a discipline. They generally prefer not to be involved in the design of regulatory field trials or regulatory issues related to the evaluation of events. In that sense, some of the aspects considered a regulatory affairs platform for the public scientific system and the reinforcement of laboratories that perform tests required under the Argentine regulation.

Familiarity in the Context of Risk Assessment of Transgenic Crops: Focus on Some Countries in the Americas.

Problem formulation is the formal opening stage of a risk assessment that determines its purpose and scope and hence guides the gathering of information data. The concepts of familiarity and history of safe use are an integral part of problem formulation. These concepts do not replace the case-by-case approach and are not taken as safety standards but are valuable components of the process that shape the generation of plausible, testable risk hypotheses. The International Life Sciences Institutes in Brazil and Argentina have facilitated numerous discussions on the scientific principles for risk assessment of transgenic crops in the Latin American region in the past 5-6 years. The session held at ISBR 15th elaborated on the familiarity concept and derived tools and their role in the evolution of risk evaluation criteria. Examples of how different countries in the Americas interpret and apply these conceptual tools show that familiarity is a valuable concept, although terms are very often confused and vaguely defined. Formalizing these terms with clear definitions and scope of application in guidelines and regulatory documents would reduce ambiguity, enhance predictability, and add transparency to the evaluation processes.

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.

Proposed criteria for identifying GE crop plants that pose a low or negligible risk to the environment under conditions of low-level presence in seed.

The low-level presence (LLP) of genetically engineered (GE) seeds that have been approved in the country of origin but not the country of import presents challenges for regulators in both seed importing and exporting countries, as well as for the international seed trade and the farmers who rely on it. In addition to legal, financial and regulatory challenges, such LLP situations in seed may also require an environmental risk assessment by the country of import. Such assessments have typically been informed by the national framework established to support decisions related to wide scale cultivation, and frequently do not take into account the low environmental exposure and prior regulatory history of the GE plant. In addition, such assessment processes may not be well suited to the decision-making timeframe that is necessary when dealing with an LLP situation in imported seed. In order to facilitate regulatory decision making, this paper proposes a set of scientific criteria for identifying GE crop plants that are expected to pose a low or negligible risk to the environment under LLP conditions in seed. Regulatory decision makers in some importing countries may decide to use these criteria to assist in risk analysis associated with LLP situations they are experiencing or could experience in the future, and might choose to proactively apply the criteria to identify existing GE plants with regulatory approvals in other countries that would be expected to pose low risk under conditions of LLP in seed.