Progress in the environmental risk assessment of plant protection products in Brazil: An overview of birds and mammals and soil organisms proposals.

Since 2019, the Brazilian Institute of Environment and Renewable Natural Resources (IBAMA) has actively developed pesticide environmental risk assessment (ERA) frameworks adapted to Brazil's specific ecological contexts. This initiative, supported by funding from the Brazilian Ministry of Justice and in partnership with academic institutions, has led to a concerted effort to establish ERA protocols for various taxa, including birds and mammals, soil organisms, aquatic organisms, and reptiles and amphibians. The outcomes of this initiative were disseminated in two distinct workshops held in February and November of 2023, where the agency showcased its research to the technical-regulatory community. This article synthesizes the proposals for birds and mammals and soil organisms. First, we summarize the agency's proposals for both focal and generic species to be incorporated into the ERA and the methodologies for calculating exposure of these taxa to pesticides through agricultural practices, encompassing seed treatment and foliar applications. On this occasion, IBAMA also disclosed the risk assessment tool that the agency is developing for birds and mammals. IBAMA highlighted the knowledge gaps that must be bridged to progress from preliminary (lower-tier) to more comprehensive (higher-tier) assessments. Regarding soil organisms, during the workshop, the presenters shared findings on the most prevalent species of earthworms and enchytraeids in Brazil. They emphasized the need for additional data collection on a regional scale. The agency has also proposed methods for estimating soil organism exposure to pesticides at a screening level and identified specific data gaps that could be addressed to refine assessments at higher tiers. In summary, the workshop communicated the progress in establishing ERA guidelines, which we encapsulate here to benefit the technical-regulatory community. © 2024 The Author(s). Integrated Environmental Assessment and Management published by Wiley Periodicals LLC on behalf of Society of Environmental Toxicology & Chemistry (SETAC).

Progress in the environmental risk assessment of plant protection products in Brazil: An overview of aquatic organism proposals.

Since 2019, the Brazilian Institute of Environment and Renewable Natural Resources (IBAMA) has actively developed pesticide environmental risk assessment (ERA) frameworks adapted to Brazil's specific ecological contexts. This endeavor, supported by funding from the Brazilian Ministry of Justice and in partnership with academic institutions, has led to a concerted effort to establish ERA protocols for various taxa, including birds and mammals, soil organisms, aquatic organisms, and reptiles and amphibians. The outcomes of this initiative were conveyed in two workshops held in February and November 2023, during which the agency communicated its findings to the technical-regulatory community. This article represents one of three articles that provide more detailed insights into the ERA propositions for all taxa. In this article, we summarize the proposals for aquatic organisms presented and discussed during the workshops, which can be used as an informational source by the technical-regulatory community. Integr Environ Assess Manag 2024;00:1-6. © 2024 The Author(s). Integrated Environmental Assessment and Management published by Wiley Periodicals LLC on behalf of Society of Environmental Toxicology & Chemistry (SETAC).

Proposal for a tiered regulatory framework for the aquatic risk assessment of pesticides in Brazil.

Aquatic risk assessment is essential to guarantee the sustainable use of pesticides and the conservation of water resources near agricultural fields. This article discusses a proposal for a tiered regulatory framework for the aquatic risk assessment of pesticides in Brazil. The first step is problem formulation, which includes establishing general and specific protection goals. In the exposure assessment, the Estimated Environmental Concentrations in water should be calculated based on realistic worst-case assumptions regarding application rate and frequency, the entry into the edge-of-field water body, and fate in the water body, using scenario-dependent models suggested by the Brazilian Environmental Agency. These calculations can be refined by including Efate studies with variable exposures to reflect realistic environmental conditions accurately and include mitigation measures that impact the modeling. In the hazard assessment, ecotoxicological data for toxicity to fish, aquatic invertebrates, algae, and aquatic plants should be required for all pesticides based on standardized protocols and species. Tier 2 has several refinement options, including incorporating toxicity data from additional test species and effect modeling. In Tier 3, population- and community-level effects are evaluated using semi-field studies. Considering the case study in Brazil, Tier 1 demonstrated that, from the 12 pesticides that were assessed, seven (58%) failed based on the value of the Risk Quotient. In Tier 2, when exposure refinement options and mitigation measures such as buffer zones are considered, all seven pesticides, for which Tier 1 indicated risk, still failed the assessment. The risk for four of these seven pesticides could be refined by considering toxicity information from additional species. Refinement options and mitigation measures that could be applied to the agricultural scenario in Brazil were discussed. In conclusion, the proposed tiered risk assessment is a feasible way to evaluate whether a pesticide will pose an unacceptable risk to aquatic organisms. Integr Environ Assess Manag 2024;00:1-15. © 2024 The Authors. Integrated Environmental Assessment and Management published by Wiley Periodicals LLC on behalf of Society of Environmental Toxicology & Chemistry (SETAC).

Applying a tiered environmental risk assessment framework to estimate the risk of pesticides to soil organisms in Latin America.

This work investigates the application of a tiered risk assessment scheme for soil organisms based on the risk quotient (RQ) and the toxicity exposure ratio (TER). Forty-five pesticides registered in Latin America were chosen and the ecotoxicological endpoints for earthworms, Collembola, and microorganisms were collated. Tier I assessment was made on conservative assumptions in which no refinements were applied. There, 14 pesticides (31%) exceed the RQ regulatory trigger indicating unacceptable risk, whereas 27 (60%) indicate unacceptable risk on the TER approach. In a Tier II evaluation when refinement options such as foliar interception, field half-life, and the dissipation following the peak estimated environmental concentration are considered, eight (18%) pesticides indicate unacceptable risk based on the RQ, and 15 (33%) indicate unacceptable risk based on the TER. A nonmetric multidimensional scaling evaluation was performed to understand the relevant characteristics involved in how each pesticide poses a risk to soil organisms. Based on the outcome of this analysis, we observed that, for a given pesticide, the combination of high persistence, low or no crop interception, and high toxicity are likely to require higher tier risk assessment. Refinement options can consider either or both the exposure and/or the effect side of the framework. Exposure refinements are potentially simpler and can be conducted with data already available to risk assessors, whereas effect refinements involving further testing with the organisms potentially at risk are still under discussion for intermediate and higher tiers. A sensitive, simple, and logical environmental risk assessment framework can be used to adequately identify risks based on the relevant protection goals that, in turn, will help to protect the desired soil multifunctionality of the ecosystem. We encourage academia and industry to further investigate these topics to provide the most scientifically robust and evidence-based information to decision makers. Integr Environ Assess Manag 2023;19:446-460. © 2022 SETAC.

Estimating pesticide environmental concentrations in Latin America: The importance of developing local scenarios.

Data to assess pesticide exposure in soil and water are scarce and unevenly distributed in Latin America, especially due to the size of the region and the vast agricultural landscape. This makes it difficult to assess associated environmental risks. We suggest that the lack of pesticide exposure or monitoring data can be addressed by using validated models to provide estimated pesticide exposure concentrations in soil and water bodies. This exposure modeling approach has been used by regulatory agencies in other countries and regions such as the United States, Canada, and the European Union. In order to properly estimate pesticide exposure concentrations, we advocate for the development of local scenarios containing local weather, soil, and crop data to be used in the existing models. A sensitivity analysis of the models can be performed to determine parameters that are sensitive and therefore inputs to these parameters are derived locally. We believe the development of local scenarios in the region is attainable and can be a pragmatic approach for developing a more comprehensive picture of potential pesticide exposure in the region. Integr Environ Assess Manag 2021;17:901-904. © 2021 Syngenta Proteção de Cultivos Ltda.

Development and validation of an HPLC method for stability evaluation of nystatin

A liquid chromatography method for evaluating the stability of Nystatin (Nys) in an ointment was developed and validated, since the traditional pharmacopeial microbiological methods are unable to indicate stability. The stress experiments showed that Nys was found to significantly degrade in alkaline and acidic conditions and also under oxidative stress. Lower levels of degradation were detected under heat and with the sample exposed to Xenon light. Resolutions higher than 2 for Nys and degradation products (DP) chromatographic peaks were achieved by using an Inerstil ODS-3 column, isocratic elution with methanol:water and UV detection at 305 nm. The system was found to be linear over a range of 102 to 310 IU mL-1 and proved precise, since the RSD( percent) was 0.24 percent for the six replicates tested. The method also exhibited good levels of recovery (from 98.24 percent to 100.74 percent). Therefore, the validation fulfilled pharmacopeial requirements and the procedure was found to be reliable, precise, accurate and selective for determination of Nys and its degradation products.

Um método indicador de estabilidade por cromatografia líquida foi desenvolvido e validado para a análise de Nistatina (Nys) em uma pomada, uma vez que os métodos microbiológicos tradicionais não têm a habilidade de serem indicadores de estabilidade. A nistatina degradou significativamente em condições alcalinas e ácidas e também em meio oxidante. Quando a amostra foi exposta a luz de xenônio, foram observados menores níveis de degradação. A resolução entre os picos cromatográficos de Nys e seus produtos de degradação (PD) foi maior que 2, utilizando-se uma coluna Inerstil ODS-3, eluição isocrática com metanol: água e detecção no UV em 305 nm. O sistema foi linear entre a faixa de 102 a 310 UI mL-1 e preciso uma vez que o DPR( por cento) foi de 0,24 por cento entre as seis replicatas testadas. Além disso, o método exibiu bons níveis de recuperação (de 98,24 por cento a 100,74 por cento). Consequentemente, considera-se que a validação atendeu a todos os requisitos farmacopêicos e o método pode ser considerado confiável, preciso, exato e seletivo para determinação de Nys e seus produtos de degradação.