A new regulatory paradigm for pesticide registration in Brazil: Comments on recent legislative amendments (Law 14.785/2023)

Abstract

Brazil, a country of immense ecological diversity, has emerged as a global agricultural powerhouse, playing a pivotal role in international food production (Ballarin et al., 2023). With over 20% of the world's species thriving in its six biomes (Ministério do Meio-Ambiente e Mudança do Clima, 2024), any changes to Brazil's regulatory framework that impacts its agricultural and livestock production can have far-reaching global implications (Abessa et al., 2019; Fearnside, 2016). This is particularly true for the regulation and registration of pesticides, a crucial aspect of Brazil's agricultural paradigm, given its status as one of the world's major food exporters (Oliveira et al., 2014).

On 27 December 2023, the Brazilian National Congress approved a new regulation for pesticide registration in Brazil, embodied by Law 14.785 (Brasil, 2023). The new Brazilian law represents a scientific shift in paradigm, particularly given that it now mandates the inclusion of pesticide risk assessments—encompassing both human and environmental assessments—as integral components of the dossier submission process. Before this legislative revision, the evaluation of pesticides' risks concerning human health and the environment was solely predicated on hazard classification, based on the outcome of toxicological and ecotoxicological studies that are part of the dossier submission. Consequently, this regulatory update holds the potential to align the Brazilian regulatory framework more closely with those of more established systems, such as those implemented in Europe and the United States. The primary objective of this letter is to discuss the recent regulatory shift. The authors do not intend to apply any judgments, even implications and/or impacts of this regulatory shift. The purpose of informing is to communicate and provide awareness at this point. The authors also plan to publish other papers where more detailed information will be provided per compartment (e.g., birds and mammals, soil organisms).

Based on the considerations above, the authors believe that from a technoregulatory point of view, there are elements for establishing Tier 1 (screening level) for aquatic organisms, soil organisms, birds, and mammals. At the same time, the implementation of higher tiers needs more discussion. Ideally, these discussions should include the regulatory agencies, academia, and the regulated sector, aiming to address current knowledge gaps and the implementation of a tiered ERA scheme that not only considers the local reality but can protect the environment while still supporting Brazilian agriculture.

In conclusion, the newly established paradigm constitutes a significant transformation within Brazil's technical and regulatory landscape. This shift heralds the potential requirement for environmental research involving novel species. As previously delineated, implementing standardized ecotoxicological tests for local and new species is financially and temporally demanding, escalating the complexity of study design, execution, and subsequent interpretation. These factors suggest that ERA could be a powerful tool in bolstering Brazil's sustainability objectives, acknowledging that sustainability is an amalgamation of environmental, societal, and economic aspects.

Ana P. Cione: Conceptualization; writing—original draft; writing—review and editing. Gustavo S. Santos: Writing—review and editing. Mario del Giudice Paniago: Writing—review and editing. Marina Sales: Writing—review and editing. Fábio Casallanovo: Writing—review and editing.

All authors declare that the Syngenta companies employ them as declared in their affiliations.