Challenge of the use of drugs in fish farming in the context of One Health: evaluation of efficacy, safety and risk analysis

Abstract

One of humanity's greatest challenges is ensuring food security in a sustainable production system in line with the One Health concept. Foods from aquaculture with high nutritional quality are decisive in producing animal protein. Brazil has enormous potential to leverage aquaculture exploitation due to its favorable climatic conditions and extensive water resources that allow the production of a wide variety of fish species. The expansion of the sector in the country favors the production of food for the national and international market and contributes to the generation of jobs.The implementation of intensive and/or super-intensive production systems in fish farming is more vulnerable to the spread of infectious diseases among animals in case of occurrence of microbial pathogens, directly affecting fish health and food safety to consumers. Furthermore, in contrast to other agricultural sectors, aquaculture in Brazil still lacks authorized veterinary medicines intended to treat fish diseases. Add to this that the few products for use in fish had their studies carried out in countries of the northern hemisphere and not in countries with tropical and sub-tropical climates, such as Brazil, which has higher water body temperatures, which will directly influence the pharmacokinetic parameters, which are essential when considering food safety, since these parameters will establish, among other factors, the residue concentrations in the edible tissue and the withdrawal time (withdrawal period) of a drug to be indicated for the animal in question. One of the factors that need to be considered in the continued use of antimicrobial drugs in food-producing animals is the possible development of antimicrobial resistance, which can impact animal, human, and environmental health. Therefore, this productive sector urges for more alternative products for veterinary use, with studies carried out considering the national breeding conditions, which are effective and safe for animals and the consumer.Cooperation between the private sector and academia is a fundamental strategy to meet this demand. For medicines to be authorized for use, in addition to having proven efficacy, they must undergo a risk assessment that encompasses animal, human and environmental health. In the context of risk assessment, it is necessary to carry out clinical studies with the radiolabeled drug. Therefore, it is essential to have an infrastructure to carry out clinical trials and laboratory analysis that allow working with radiolabelled molecules within the standards of security (radioprotection). Added to this is the need to assess the impact of these veterinary products on the environment and, in the case of antimicrobials, the importance of evaluating antimicrobial resistance to these drugs.Therefore, the main goal of this research project is to establish a pioneering infrastructure in Brazil that allows the evaluation of the efficacy and safety of the use of veterinary drugs in Brazilian fish farming so that the country can leverage production in this sector and contribute to food safety in a sustainable way and in line with the One Health concept (animal health, human health, and environmental protection). This pioneering infrastructure is a starting point for Brazil to have knowledge of norms, methods, and procedures to assess the safety of the use of veterinary drugs in the agricultural sector and will have long-term continuity, serving other projects in the future. To overcome the challenges, this study has the participation of researchers from the three state universities in São Paulo, private sector investment, international collaboration with a consortium with the European Community, in addition to the support of MAPA and the International Atomic Energy Agency. (AU)