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Implementing a globally harmonized risk assessment-based approach for regulatory decision-making of crop protection products.
Pest Management Science ( IF 4.1 ) Pub Date : 2020-02-20 , DOI: 10.1002/ps.5793
Douglas C Wolf 1 , Manoj Aggarwal 2 , Michael Battalora 3 , Ann Blacker 4 , Shadia I Catalano 5 , Karen Cazarin 6 , Daniele Lautenschalaeger 7 , Mariana C Pais 8 , Mauricio Rodríguez 9 , Kent Rupprecht 4 , Tessa L Serex 3 , Jyotigna Mehta 10
Affiliation  

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

中文翻译:

实施基于全球统一风险评估的方法,用于农作物保护产品的监管决策。

一个基于接触量和风险的全球统一的农作物保护化学品评估系统将提高告知风险管理决策的能力并更好地支持创新。这将通过以下方法来实现:基于最佳风险科学的统一协调,基于风险评估的监管决策新方法和传统数据的集成,以创建量身定制的,受风险驱动的风险评估。成功的要求是一种鼓励监管机构与受监管行业之间进行直接沟通的结构,这将使新技术和科学的进步更加迅速。模仿国际药品协调会议(ICH)的方法,将监管机构和受监管行业以及来自学术界和非政府组织的相关专家召集在一起,讨论科学技术的进步及其实施。这些讨论还将鼓励消除过时的实践,这些过时的实践不再具有导致对数据评估更加统一的测试要求和最佳实践的目的,以支持安全使用以及具有科学依据的人类健康和环境风险评估。新兴技术为改善当前的毒性测试范例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。实施统一方法将提高人类健康和环境保护法规决策的速度,效率和准确性,同时提高为农业界提供安全有效的创新产品的效率。©2020化学工业协会 提高人类健康和环境保护法规决策的效率和准确性,同时提高向农业界提供安全有效的创新产品的效率。©2020化学工业协会 提高人类健康和环境保护法规决策的效率和准确性,同时提高向农业界提供安全有效的创新产品的效率。©2020化学工业协会
更新日期:2020-02-20
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