2019
DOI: 10.3390/ijerph16101738
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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

Abstract: 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… Show more

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Cited by 10 publications
(12 citation statements)
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“…1. Recent exposure reconstruction efforts which indicate that historical worker exposures may have been considerably higher than estimated for USEPA unit risk values (Bogen et al 2019). In addition, the unit risk value should be assessed in terms of total exposures to workers, rather than relying solely on the characterization of the exogenous pathway, and include three components: (A) endogenous production; (B) exogenous occupational exposure; and (C) exogenous exposures from smoking, for which historical exposures are expected to be larger than current exposures due to changes in smoking habits (Table 7); 2.…”
Section: Discussionmentioning
confidence: 99%
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“…1. Recent exposure reconstruction efforts which indicate that historical worker exposures may have been considerably higher than estimated for USEPA unit risk values (Bogen et al 2019). In addition, the unit risk value should be assessed in terms of total exposures to workers, rather than relying solely on the characterization of the exogenous pathway, and include three components: (A) endogenous production; (B) exogenous occupational exposure; and (C) exogenous exposures from smoking, for which historical exposures are expected to be larger than current exposures due to changes in smoking habits (Table 7); 2.…”
Section: Discussionmentioning
confidence: 99%
“…Occupational exposures to ethylene oxide are associated with specific industries including hospital workers (Haufroid et al 2007), sterilization workers (Bogen et al 2019), chemical manufacturing workers (Swaen et al 2009;Teta, Benson, and Vitale 1993), and fruit store workers exposed to plant-produced ethylene (Tornqvist et al, 1989). An exposure reconstruction of sterilization operators exposed to ethylene oxide was recently conducted (Bogen et al 2019). Estimated historical exposures to ethylene oxide by sterilization operators are many orders of magnitude higher than those encountered today.…”
Section: Other Potential Pathwaysmentioning
confidence: 99%
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“…In contrast, the Texas Commission on Environmental Quality (TCEQ) using the same cohort data as EPA IRIS, but a different dose-response model, estimated 10 −6 to 10 −4 RSCs of 0.24 to 24 ppb, respectively [ 6 ]. We note that neither the EPA nor TCEQ addressed the assumption of low exposure concentrations for early sterilization workers, which was shown to be invalid [ 7 ]. The EPA assessment short comings left a gap in our ability to interpret the health significance of general population exogenous EO background exposures from non-industrial and natural EO sources, and, perhaps more importantly, local general population exposures from point source industrial emissions.…”
Section: Introductionmentioning
confidence: 99%
“…More importantly, these RSCs are more than three orders of magnitude below airborne concentrations equivalent to endogenously produced EO, in the general nonsmoking population (mean concentrations of ~1.9 and 2.9 ppb) based on data evaluated by Kirman and Hays [ 2 ], based on data from published unexposed control subjects [ 8 , 9 , 10 , 11 , 12 , 13 , 14 , 15 , 16 , 17 ] and Kirman et al [ 3 ], and based on data from nonsmoking U.S. individuals [ 4 ], respectively. For additional perspective, as described by Bogen et al [ 7 ], these RSCs are up to seven orders of magnitude below the levels of EO to which 1930s–1970s sterilization operators and other highly exposed sterilization workers in the National Institute for Occupational Safety and Health (NIOSH) cohort used by EPA in its risk assessment were exposed (50,000 to >100,000 ppb). Based on these comparisons, it is obvious that the EPA RSCs are incapable of providing useful benchmarks to evaluate the health significance of such low general population EO exposures.…”
Section: Introductionmentioning
confidence: 99%