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首页> 美国卫生研究院文献>International Journal of Environmental Research and Public Health >Reevaluation of Historical Exposures to Ethylene Oxide Among U.S. Sterilization Workers in the National Institute of Occupational Safety and Health (NIOSH) Study Cohort
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Reevaluation of Historical Exposures to Ethylene Oxide Among U.S. Sterilization Workers in the National Institute of Occupational Safety and Health (NIOSH) Study Cohort

机译：美国国家职业安全与健康研究所（NIOSH）研究队列中的美国灭菌工人对环氧乙烷的历史暴露进行了重新评估

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摘要

The 2016 U.S. Environmental Protection Agency (EPA) Integrated Risk Information System (IRIS) assessment for ethylene oxide (EO) estimated a 10−6 increased inhalation cancer risk of 0.1 parts per trillion, based on National Institute of Occupational Safety and Health (NIOSH) epidemiology studies of sterilization facility workers exposed to EO between 1938 and 1986. The worker exposure estimates were based on a NIOSH statistical regression (NSR) model “validated” with EO levels measured after 1978. Between 1938 and 1978, when EO data was unavailable, the NSR model predicts exposures lowest in 1938 increasing to peak levels in 1978. That increasing EO concentration trend arose, in part, because engineering/industrial-hygiene (E/IH) factors associated with evolving EO-sterilization equipment and operations before 1978 were not properly considered in the NSR model. To test the NSR model trend prediction, a new E/IH-based model was developed using historical data on EO kill concentrations, EO residue levels in sterilized materials, post-wash EO concentrations in a sterilization chamber, and information on facility characteristics and sterilizer operator practices from operators familiar with pre-1978 industry conditions. The E/IH 90th percentile of 8 h time-weighted average EO exposures (C90) for highly exposed sterilizer operators was calibrated to match 1978 C90 values from the NSR model. E/IH model C90 exposures were estimated to decrease over time from levels 16 and were four-fold greater than NSR-estimated exposures for workers during 1938–1954 and 1955–1964. This E/IH modeled trend is opposite to that of NSR model predictions of exposures before 1978, suggesting that EPA’s exclusive reliance on the NIOSH cohort to estimate EO cancer risk should be re-examined.
机译：根据美国国立卫生研究院的数据，2016年美国环境保护局（EPA）对环氧乙烷（EO）的综合风险信息系统（IRIS）评估估计，吸入癌症的风险增加10 -6 0.1万亿分之0.1。 1938年至1986年间对暴露于EO的绝育设施工人的职业安全与卫生（NIOSH）流行病学研究。工作人员的暴露估计基于1978年后测得的EO水平的“经验证”的NIOSH统计回归（NSR）模型。 ，当无法获得EO数据时，NSR模型预测1938年的最低暴露量将增加到1978年的峰值水平。这种EO浓度增加的趋势之所以出现，部分是因为与不断发展的EO灭菌有关的工程/工业卫生（E / IH）因素NSR模型未适当考虑1978年之前的设备和操作。为了测试NSR模型趋势预测，使用有关EO杀灭浓度，灭菌材料中EO残留水平，灭菌室中洗后EO浓度以及设施特征和灭菌器信息的历史数据开发了基于E / IH的新模型熟悉1978年前行业状况的操作员的操作员实践。对高度暴露的灭菌器操作员进行的8小时时间加权平均EO暴露（C90）的E / IH 90％百分数进行了校准，以匹配NSR模型中的1978 C90值。据估计，E / IH模型C90的暴露量会随着时间的推移从16级下降，并且是1938–1954年和1955–1964年期间工人的NSR估算暴露量的四倍。这种以E / IH模式为模型的趋势与1978年之前的NSR模型所预测的趋势相反，这表明应该重新审查EPA完全依赖NIOSH人群来估计EO癌症风险。

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