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实施基于全球协调的风险评估方法,用于作物保护产品的监管决策。

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

机构信息

Syngenta, Greensboro, North Carolina, USA.

Corteva, Indianapolis, Indiana, USA.

出版信息

Pest Manag Sci. 2020 Oct;76(10):3311-3315. doi: 10.1002/ps.5793. Epub 2020 Mar 4.

DOI:10.1002/ps.5793
PMID:32077588
Abstract

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.

摘要

基于暴露和风险的作物保护化学品全球协调评估系统将提高为风险管理决策提供信息的能力,并更好地支持创新。这将通过基于风险评估的协调监管决策来实现,方法是通过应用最佳现有科学,整合新方法和传统数据,为量身定制的暴露驱动型风险评估创造条件。取得成功的一个要求是建立一个鼓励监管机构与受监管行业之间直接沟通的结构,这将使新技术和先进科学更快地融入。仿效国际人用药品注册协调会议(ICH)的方法将汇集监管机构和受监管行业以及学术界和非政府组织的相关专家,讨论科学和技术进步及其实施情况。这些讨论还将鼓励消除不再具有实际意义的过时做法,从而导致更统一的测试要求和最佳数据评估实践,以支持安全使用和具有科学依据的人类健康和环境风险评估。新出现和发展中的技术为改善当前的毒性测试范式提供了令人兴奋的机会,以提供更好的解决方案并减少动物测试。实施协调方法将提高人类健康和环境保护的监管决策速度、效率和准确性,同时提高向农业社区提供安全有效创新产品的效率。© 2020 英国化学工程师学会。

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引用本文的文献

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Transforming the evaluation of agrochemicals.转变农化品评估方式。
Pest Manag Sci. 2022 Dec;78(12):5049-5056. doi: 10.1002/ps.7148. Epub 2022 Sep 14.