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Comprehensive framework for human health risk assessment of nanopesticides
Nature Nanotechnology ( IF 38.3 ) Pub Date : 2021-09-13 , DOI: 10.1038/s41565-021-00964-7
Melanie Kah 1 , Linda J Johnston 2 , Rai S Kookana 3, 4 , Wendy Bruce 5 , Andrea Haase 6 , Vera Ritz 7 , Jordan Dinglasan 8 , Shareen Doak 9 , Hemda Garelick 10 , Vladimir Gubala 11
Affiliation  

Nanopesticides are not only in an advanced state of research and development but have started to appear on the market. Industry and regulatory agencies need a consolidated and comprehensive framework and guidance for human health risk assessments. In this perspective we develop such a comprehensive framework by exploring two case studies from relevant product types: an active ingredient delivered with a nanocarrier system, and a nanoparticle as an active ingredient. For a nanocarrier system, three entities are tracked during the assessment: the nanocarrier–active ingredient complex, the empty nanocarrier remaining after the complete release of the active ingredient, and the released active ingredient. For the nanoparticle of pure active ingredient, only two entities are relevant: the nanoparticle and the released ions. We suggest important adaptations of the existing pesticide framework to determine the relevant nanopesticide entities and their concentrations for toxicity testing. Depending on the nature of the nanopesticides, additional data requirements, such as those pertaining to durability in biological media and potential for crossing biological barriers, have also been identified. Overall, our framework suggests a tiered approach for human health risk assessment, which is applicable for a range of nanopesticide products to support regulators and industry in making informed decisions on nanopesticide submissions. Brief summaries of suitable methods including references to existing standards (if available) have been included together with an analysis of current knowledge gaps. Our study is an important step towards a harmonized approach accepted by regulatory agencies for assessing nanopesticides.



中文翻译:

纳米农药人体健康风险评估综合框架

纳米农药不仅处于先进的研发状态,而且已经开始出现在市场上。行业和监管机构需要一个综合全面的人类健康风险评估框架和指南。从这个角度来看,我们通过探索相关产品类型的两个案例研究来开发这样一个综合框架:一种通过纳米载体系统递送的活性成分,以及一种作为活性成分的纳米颗粒。对于纳米载体系统,在评估过程中跟踪三个实体:纳米载体-活性成分复合物、活性成分完全释放后剩余的空纳米载体和释放的活性成分。对于纯活性成分的纳米颗粒,只有两个实体是相关的:纳米颗粒和释放的离子。我们建议对现有农药框架进行重要调整,以确定相关的纳米农药实体及其毒性测试浓度。根据纳米杀虫剂的性质,还确定了额外的数据要求,例如与生物介质中的耐久性和穿越生物屏障的潜力有关的数据要求。总的来说,我们的框架提出了一种用于人类健康风险评估的分层方法,适用于一系列纳米农药产品,以支持监管机构和行业对纳米农药提交做出明智的决定。包括对现有标准(如果可用)的参考的合适方法的简要总结以及对当前知识差距的分析。

更新日期:2021-09-13
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