开发评估作物保护化学品安全性的现代化方法原型。

IF 4.5 2区 医学 Q2 MEDICINE, RESEARCH & EXPERIMENTAL Altex-Alternatives To Animal Experimentation Pub Date : 2024-01-09 Epub Date: 2023-08-31 DOI:10.14573/altex.2307181
Richard A Currie, John Abbott, David A Dreier, Haitian Lu, Tharacad Ramanarayanan, Natalia Ryan, Odette A Watkins, Douglas C Wolf
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引用次数: 0

摘要

2019 年,美国环保署署长发布指令,要求该机构在 2035 年之前不再依赖脊椎动物测试,同时保持高质量的人类健康和环境风险评估。 目前还没有公认的方法来实现这一目标。因此,作物保护 (CP) 化学品研发过程长达十年之久,这就要求在 2020 年代中期之前,对进入企业研究组合的 CP 化学品项目发明和应用现代化方法。 因此,我们与监管机构的科学家们就问题的提出进行了讨论,并提出了问题陈述:"开发、演示和实施一种科学合理且稳健的现代策略,在不进行特定于化学物质的脊椎动物试验的情况下,应用适当且灵活的暴露和效应特征描述,以可靠的方式解决数据及其解释中的风险、不确定性和缺陷,并与当前公认的试验准则具有同等的可信度,同时满足监管机构的监管需求"。 解决方案必须提供所需的知识,以便有把握地完成人类健康和环境保护风险评估。通过对这一问题的探讨,提出了一个概念模型,即创建并同时提交一种不依赖于特定脊椎动物化学试验的新方法。 与传统方法同时进行的评估将确定该方法是否支持部分或全部必要的风险管理行动。 对任何缺陷的分析都将提供有价值的反馈,以便为后续迭代集中开发工具或方法。当发现该方法能够提供足够的信息时,它将成为利益相关者参与的技术基础,以探索是否接受新的氯化石蜡化学品风险评估方法。
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Developing prototypes of a modernized approach to assess crop protection chemical safety.

In 2019, the US EPA Administrator issued a directive directing the agency away from reliance on vertebrate tests by 2035, whilst maintaining high-quality human health and environmental risk assessments. There is no accepted approach to achieve this. The decade-long duration of the crop protection (CP) chemical R&D process therefore requires both the invention and application of a modernized approach to those CP chemical projects entering corporate research portfolios by the mid-2020s. We conducted problem formulation discussions with regulatory agency scientists which created the problem statement: “Develop, demonstrate, and implement a modern scientifically sound and robust strategy that applies appropriate and flexible exposure and effects characterization without chemical specific vertebrate tests to reliably address risk, uncertainties, and deficiencies in data and its interpretation with equivalent confidence as do the currently accepted test guidelines and meet the regulatory needs of the agencies”. The solution must provide the knowledge needed to confidently conclude human health and environmental protective risk assessments. Exploring this led to a conceptual model involving the creation and parallel submission of a new approach without reliance on chemical-specific vertebrate tests. Assessment in parallel to a traditional package will determine whether it supports some, or all, of the necessary risk management actions. Analysis of any deficiencies will provide valuable feedback to focus development of tools or approaches for subsequent iterations. When found to provide sufficient information, it will form the technical foun­dation of stakeholder engagement to explore acceptance of a new approach to CP chemical risk assessment.

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来源期刊
Altex-Alternatives To Animal Experimentation
Altex-Alternatives To Animal Experimentation MEDICINE, RESEARCH & EXPERIMENTAL-
CiteScore
7.70
自引率
8.90%
发文量
89
审稿时长
2 months
期刊介绍: ALTEX publishes original articles, short communications, reviews, as well as news and comments and meeting reports. Manuscripts submitted to ALTEX are evaluated by two expert reviewers. The evaluation takes into account the scientific merit of a manuscript and its contribution to animal welfare and the 3R principle.
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