Implementing a globally harmonized risk assessment-based approach for regulatory decision-making of crop protection products.

A global, harmonized evaluation system for crop protection chemicals based on exposure and risk will improve the ability to inform risk management decisions and better support innovation. This would be achieved through harmonized risk assessment-based regulatory decision-making realized through the application of the best available science, via integration of new methods and traditional data to create tailored exposure-driven risk assessments. A requirement to achieve success is a structure that encourages direct communication between the regulatory community and the regulated industry, which would enable a more rapid incorporation of new technologies and advancing science. An approach that emulates the International Conference of Harmonization (ICH) for pharmaceuticals would bring together regulatory authorities and the regulated industry along with relevant experts from academia and Non-Governmental Organizations to discuss scientific and technical advances and their implementation. These discussions would also encourage the elimination of outmoded practices that no longer serve a purpose resulting in more uniform testing requirements and best practices for data evaluation to support safe use and scientifically defensible human health and environmental risk assessments. New and developing technologies offer exciting opportunities to improve the current toxicity testing paradigms to provide better solutions and diminish animal testing. Implementation of a harmonized approach will increase the speed, efficiency and accuracy of regulatory decision-making for human health and environmental protection while increasing the efficiency of providing safe and effective innovative products to the agriculture community. © 2020 Society of Chemical Industry.

Non-relevance of acute dermal toxicity testing for assessing human health protection in the regulatory decision-making for agrochemical formulated products.

Compared to oral toxicity tests, dermal toxicity tests offer little or no additional scientific information or public health protection for agrochemical-formulated products (US EPA, 2016). Based on that, a retrospective analysis of the results of acute oral and dermal LD50 studies of agrochemical products registered in Brazil was carried out by the Technical Group on Toxicological Risk Assessment (GT-ART) of the Brazilian Crop Protection Association (ANDEF). The data were obtained from 6 agrochemical industries that are associated to ANDEF, following these considerations: only rat studies were selected; only paired studies were chosen; only studies performed with top doses ≥2,000 mg/kg were selected; biological products were excluded. The dataset includes 342 formulated products in 21 formulation types. Among these 342 formulated products, 228 have a single active ingredient, 107 have 2 and 7 have 3 or more. The comparison of acute oral to dermal toxicity studies of agrochemical-formulated products registered in Brazil corroborates the United States Environmental Protection Agency (US EPA) conclusion on waiving acute dermal toxicity tests, which will result in avoiding unnecessary use of time and resources, data generation costs and animal testing.

Intoxicação por chumbinho: um desafio para o diagnóstico clínico e para o tratamento / Chumbinho poisoning: challenge to clinical diagnosis and treatment

As intoxicações por chumbinho, principalmente pela população adulta e em tentativas de suicídio, são consideradas importante causa de morbi/mortalidade no Brasil, e estão relacionadas ao comércio ilegal de praguicidas inibidores da colinesterase, com o propósito de uso domissanitário, como raticida, desviando-se do uso agrícola autorizado no país. Do ponto de vista toxicológico, existem variações no quadro clínico e diferenças significantes na forma de tratamento quando se considera os inseticidas carbamatos e os organofosforados, tornando-se motivo de extrema preocupação pois, em grande parte dos casos emergenciais, o diagnóstico clínico é de difícil reconhecimento. Isso se torna um desafio no caso do chumbinho, uma vez que, na maioria das vezes, não se conhece exatamente o ingrediente ativo presente na sua formulação. Sendo assim, o propósito do presente artigo foi realizar uma abordagem crítica e atualizada sobre a problemática de uso irregular do chumbinho, incluindo a descrição de dados epidemiológicos e aspectos de avaliação clínica e das formas de tratamento mais adequadas nos casos de intoxicação por este produto

Redução, refinamento e substituição do uso de animais em estudos toxicológicos: uma abordagem atual / Reduction, refinement and replacement of animal use in toxicity testing: an overview

A avaliação da toxicidade de uma substância é realizada com o objetivo de predizer os efeitos nocivos que a mesma poderá desencadear quando da exposição humana pelas diversas vias. Para cumprir este propósito, o modelo animal é o mais utilizado nos estudos toxicológicos e requerido nos processos investigativos. Entretanto, a utilização de animais na pesquisa tem sido razão de diversas discussões em função do grande número necessário e do sofrimento causado, principalmente em relação aos estudos de toxicidade aguda. Existe uma tendência mundial para reavaliar a utilização de animais nos experimentos, concretizada a partir de um programa denominado de 3Rs (Reduction, Refinement, Replacement), que objetiva além de diminuir o número de animais, minimizar a dor e o desconforto e buscar alternativas para a substituição dos testes in vivo...