Evaluation of the reliability and relevance of toxicity and ecotoxicity studies is an integral step in the assessment of the hazards and risks of chemicals. This evaluation is inherently reliant on expert judgment, which often leads to differences between experts’ conclusions regarding how individual studies can contribute to the body of evidence. The conclusions of regulatory assessment, such as establishing safe exposure levels for humans and the environment and calculations of margins of exposure, may have large consequences for which chemicals are permitted on the market and their allowed uses. It is therefore important that such assessments are based on all reliable and relevant scientific data, and that assessment principles and assumptions, such as expert judgment, are transparently applied. It is not possible nor desirable to completely eliminate expert judgment from the evaluation of (eco)toxicity studies. However, it is desirable to introduce measures that increase structure and transparency in the evaluation process so as to provide scientifically robust risk assessments that can be used for regulatory decision making. In this article we present results from workshop exercises with Nordic experts to illustrate how experts’ evaluations regarding the reliability and relevance of (eco)toxicity studies for risk assessment may vary and discuss methods intended to promote structure and transparency in the evaluation process.

中文翻译：

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充分利用专家的判断力来评估化学品的危害和风险

评估毒性和生态毒性研究的可靠性和相关性是评估化学品危害和风险的必不可少的步骤。这种评估天生就依赖于专家的判断，这常常导致专家关于个体研究如何对证据体系做出贡献的结论之间存在差异。建立监管评估的结论，例如确定对人类和环境的安全暴露水平以及计算暴露裕度，可能会对市场上允许的化学品及其允许的使用产生重大影响。因此，重要的是，此类评估应基于所有可靠且相关的科学数据，并且透明地应用评估原则和假设（例如专家判断）。从（生态）毒性研究的评估中完全消除专家的判断是不可能的，也不是希望的。但是，希望引入可在评估过程中增加结构和透明度的措施，以便提供可用于监管决策的科学可靠的风险评估。在本文中，我们将介绍与北欧专家进行的研讨会练习的结果，以说明专家对（e）毒性研究在风险评估中的可靠性和相关性的评估可能会如何变化，并讨论旨在促进评估过程中结构和透明度的方法。希望在评估过程中引入增加结构和透明度的措施，以便提供可用于监管决策的科学可靠的风险评估。在本文中，我们将介绍与北欧专家进行的研讨会练习的结果，以说明专家对（e）毒性研究在风险评估中的可靠性和相关性的评估可能会如何变化，并讨论旨在促进评估过程中结构和透明度的方法。希望在评估过程中引入增加结构和透明度的措施，以便提供可用于监管决策的科学可靠的风险评估。在本文中，我们将介绍与北欧专家进行的研讨会练习的结果，以说明专家对（e）毒性研究在风险评估中的可靠性和相关性的评估可能会如何变化，并讨论旨在促进评估过程中结构和透明度的方法。