Risk Management Directorate, European Chemicals Agency, Postal address: P.O. Box 400, Helsinki, 00121, Finland.
Risk Anal. 2021 Apr;41(4):584-595. doi: 10.1111/risa.13666. Epub 2020 Dec 19.
Cancer risk assessments in the regulatory realm are often deterministic. Probabilistic approaches that allow characterizing and propagating uncertainty and variability are better suited to predict the socioeconomic impacts of regulating carcinogens. In this article, I present a unified framework for cancer risk management consisting of (i) a probabilistic exposure model that takes into account variability in individual exposure to the substance of concern; (ii) a probabilistic dose-response model that accounts for differences in individual cancer susceptibility; (iii) an impact assessment model that quantifies individuals' excess lifetime cancer risk; and (iv) a welfare model that values changes in disability-adjusted life expectancy based on workers' willingness-to-pay and aggregates individual valuations across the population at risk. I illustrate the framework with data on occupational exposure to hexavalent chromium in France. In a cohort of 10,000 synthetic workers, about one third of the exposed benefit from the introduction of a binding occupational exposure limit (BOEL). Limiting hexavalent chromium exposure to the BOEL reduces the statistical worker's excess lifetime risk of fatal and nonfatal lung cancer by 4.7E-3 and 1.5E-3, respectively. At cohort level, the risk reduction corresponds to 738.4 full and 30.7 disability-adjusted life years saved. The expected welfare gain of introducing the BOEL is close to €30 million. A major advantage of the framework is its ability to visualize uncertainty and variability inherent to cancer risk assessment. Notwithstanding some implementation challenges, the framework provides a transparent characterization of regulatory impacts that supports informed risk management decisions.
癌症风险评估在监管领域通常是确定性的。能够描述和传播不确定性和变异性的概率方法更适合预测监管致癌物质的社会经济影响。在本文中,我提出了一个癌症风险管理的统一框架,包括 (i) 一个概率暴露模型,该模型考虑了个体对关注物质暴露的变异性;(ii) 一个概率剂量-反应模型,该模型考虑了个体癌症易感性的差异;(iii) 一个影响评估模型,该模型量化了个体的超额终生癌症风险;和 (iv) 一个福利模型,该模型根据工人的支付意愿来衡量基于残疾调整生命年的变化,并将风险人群的个体估值汇总。我使用法国六价铬职业暴露的数据说明了该框架。在一个 10000 名合成工人的队列中,大约三分之一的暴露者受益于引入有约束力的职业暴露限值 (BOEL)。将六价铬暴露限制在 BOEL 以下,分别使致命和非致命肺癌的统计工人超额终生风险降低了 4.7E-3 和 1.5E-3。在队列水平上,风险降低对应于 738.4 个完全和 30.7 个残疾调整生命年的节省。引入 BOEL 的预期福利收益接近 3000 万欧元。该框架的一个主要优势是它能够可视化癌症风险评估中固有的不确定性和变异性。尽管存在一些实施挑战,但该框架提供了对监管影响的透明描述,支持知情的风险管理决策。