Institute of Occupational Medicine, Research Avenue North, Riccarton, Edinburgh, EH14 4AP, United Kingdom.
Centre for Occupational and Environmental Health; Centre for Epidemiology; Division of Population Health, Health Services Research and Primary Care; School of Health Sciences; Faculty of Biology, Medicine and Health; The University of Manchester, Manchester Academic Health Science Centre, Manchester M13 9PL, United Kingdom.
Ann Work Expo Health. 2017 Oct 1;61(8):921-938. doi: 10.1093/annweh/wxx056.
Tier 1 exposure tools recommended for use under REACH are designed to easily identify situations that may pose a risk to health through conservative exposure predictions. However, no comprehensive evaluation of the performance of the lower tier tools has previously been carried out. The ETEAM project aimed to evaluate several lower tier exposure tools (ECETOC TRA, MEASE, and EMKG-EXPO-TOOL) as well as one higher tier tool (STOFFENMANAGER®). This paper describes the results of the external validation of tool estimates using measurement data.
Measurement data were collected from a range of providers, both in Europe and United States, together with contextual information. Individual measurement and aggregated measurement data were obtained. The contextual information was coded into the tools to obtain exposure estimates. Results were expressed as percentage of measurements exceeding the tool estimates and presented by exposure category (non-volatile liquid, volatile liquid, metal abrasion, metal processing, and powder handling). We also explored tool performance for different process activities as well as different scenario conditions and exposure levels.
In total, results from nearly 4000 measurements were obtained, with the majority for the use of volatile liquids and powder handling. The comparisons of measurement results with tool estimates suggest that the tools are generally conservative. However, the tools were more conservative when estimating exposure from powder handling compared to volatile liquids and other exposure categories. In addition, results suggested that tool performance varies between process activities and scenario conditions. For example, tools were less conservative when estimating exposure during activities involving tabletting, compression, extrusion, pelletisation, granulation (common process activity PROC14) and transfer of substance or mixture (charging and discharging) at non-dedicated facilities (PROC8a; powder handling only). With the exception of STOFFENMANAGER® (for estimating exposure during powder handling), the tools were less conservative for scenarios with lower estimated exposure levels.
This is the most comprehensive evaluation of the performance of REACH exposure tools carried out to date. The results show that, although generally conservative, the tools may not always achieve the performance specified in the REACH guidance, i.e. using the 75th or 90th percentile of the exposure distribution for the risk characterisation. Ongoing development, adjustment, and recalibration of the tools with new measurement data are essential to ensure adequate characterisation and control of worker exposure to hazardous substances.
根据 REACH 建议使用的第 1 层暴露工具旨在通过保守的暴露预测，轻松识别可能对健康构成风险的情况。然而，之前没有对较低层工具的性能进行全面评估。ETEAM 项目旨在评估几种较低层暴露工具（ECETOC TRA、MEASE 和 EMKG-EXPO-TOOL）以及一种较高层工具（STOFFENMANAGER®）。本文描述了使用测量数据对工具估算值进行外部验证的结果。
从欧洲和美国的多个供应商收集了测量数据以及相关信息。获得了个体测量和汇总测量数据。将相关信息编码到工具中以获取暴露估计值。结果表示为超过工具估计值的测量值的百分比，并按暴露类别（非挥发性液体、挥发性液体、金属磨损、金属加工和粉末处理）呈现。我们还探索了不同工艺活动以及不同情景条件和暴露水平下工具的性能。
总共获得了近 4000 次测量的结果，其中大部分是用于挥发性液体和粉末处理。测量结果与工具估计值的比较表明，这些工具通常较为保守。然而，与挥发性液体和其他暴露类别相比，工具在估计粉末处理的暴露时更为保守。此外，结果表明工具性能在不同的工艺活动和情景条件之间存在差异。例如，在涉及压片、压缩、挤压、造粒、制粒（常见工艺活动 PROC14）和非专用设施中的物质或混合物转移（装料和卸料）的活动中（仅粉末处理），工具在估计暴露时的保守程度较低。除了 STOFFENMANAGER®（用于估计粉末处理时的暴露）外，工具在估计暴露水平较低的情况下的保守程度较低。
这是迄今为止对 REACH 暴露工具性能进行的最全面评估。结果表明，尽管通常较为保守，但这些工具并不总是能够达到 REACH 指南中规定的性能，即在风险特征描述中使用暴露分布的第 75 百分位数或第 90 百分位数。需要不断开发、调整和用新的测量数据重新校准工具，以确保对危险物质工人暴露的充分描述和控制。
