a Dipartimento di Scienze Biomediche e Cliniche, and International Centre for Pesticides and Health Risks Prevention (ICPS), ASST Fatebenefratelli Sacco, Luigi Sacco Hospital , University of Milan , Milan , Italy.
b ExxonMobil Biomedical Sciences, Inc , Annandale , NJ , USA.
Crit Rev Toxicol. 2017 Feb;47(2):85-97. doi: 10.1080/10408444.2016.1211618. Epub 2016 Aug 11.
The ILSI Health and Environmental Sciences Institute (HESI) has developed a framework to support a transition in the way in which information for chemical risk assessment is obtained and used (RISK21). The approach is based on detailed problem formulation, where exposure drives the data acquisition process in order to enable informed decision-making on human health safety as soon as sufficient evidence is available. Information is evaluated in a transparent and consistent way with the aim of optimizing available resources. In the context of risk assessment, cumulative risk assessment (CRA) poses additional problems and questions that can be addressed using the RISK21 approach. The focus in CRA to date has generally been on chemicals that have common mechanisms of action. Recently, concern has also been expressed about chemicals acting on multiple pathways that lead to a common health outcome, and non-chemical other conditions (non-chemical stressors) that can lead to or modify a common outcome. Acknowledging that CRAs, as described above, are more conceptually, methodologically and computationally complex than traditional single-stressor risk assessments, RISK21 further developed the framework for implementation of workable processes and procedures for conducting assessments of combined effects from exposure to multiple chemicals and non-chemical stressors. As part of the problem formulation process, this evidence-based framework allows the identification of the circumstances in which it is appropriate to conduct a CRA for a group of compounds. A tiered approach is then proposed, where additional chemical stressors and/or non-chemical modulating factors (ModFs) are considered sequentially. Criteria are provided to facilitate the decision on whether or not to include ModFs in the formal quantitative assessment, with the intention to help focus the use of available resources to have the greatest potential to protect public health.
国际生命科学学会（ILSI）健康与环境科学研究所（HESI）已经制定了一个框架，以支持信息获取和使用方式的转变，从而进行化学风险评估（RISK21）。该方法基于详细的问题制定，其中暴露驱动数据获取过程，以便在有足够证据时能够就人类健康安全做出明智的决策。信息以透明和一致的方式进行评估，旨在优化可用资源。在风险评估的背景下，累积风险评估（CRA）提出了可以使用 RISK21 方法解决的额外问题和疑问。迄今为止，CRA 的重点通常是具有共同作用机制的化学物质。最近，人们还对作用于导致共同健康结果的多种途径的化学物质以及非化学其他条件（非化学应激源）表示关注，这些化学物质会导致或改变共同结果。鉴于上述 CRAs 比传统的单一应激源风险评估在概念上、方法上和计算上更为复杂，RISK21 进一步为实施可行的流程和程序制定了框架，以评估多种化学物质和非化学应激源暴露的联合效应。作为问题制定过程的一部分，该基于证据的框架允许确定在适当情况下对一组化合物进行 CRA 的情况。然后提出了一种分层方法，其中依次考虑额外的化学应激源和/或非化学调节因子（ModFs）。提供了标准，以方便决定是否将 ModFs 纳入正式的定量评估，目的是帮助集中利用现有资源，以最大程度地保护公众健康。
