April 20, 2023

EPA Proposes Standards to Reduce Occupational Ethylene Oxide Exposures

EPA is proposing new health standards to reduce occupational and community exposures to ethylene oxide (EtO), the agency announced in an April 11 press release. These draft standards would require more stringent air emission controls and additional protections for workers exposed to EtO, such as those employed in facilities where the gas is used to sterilize medical equipment and a range of other products. If finalized, the proposed standards are expected to cut EtO air emissions from commercial sterilization facilities by 80 percent per year and address concerns associated with EtO pollution, such as cancer risks.

OSHA and the Agency for Toxic Substances and Disease Registry both warn that EtO is associated with a range of acute health effects, including lung irritation, and may be a carcinogen. However, EPA is advancing its new protections due to a recent assessment that found cancer risks from occupational exposures to EtO to be more significant than previously understood. According to EPA’s analysis, workers who apply EtO in sterilization and healthcare facilities over the course of a 35-year career are at increased risk for certain cancers. Workers in such facilities who do not use EtO directly and community members who live or attend schools nearby may also have increased cancer risks.

EPA’s proposed air emissions standards would require 86 facilities nationwide where EtO is used for commercial sterilization purposes, as well as all new facilities in this sector, to follow stricter pollution controls and employ advanced source monitoring methods to confirm these controls are operating effectively. These facilities would be required to report monitoring results to EPA twice per year and to comply with the new requirements within 18 months.

The proposed control measures aim to reduce health risks for workers employed at facilities where workers use EtO to sterilize products. Such measures include prohibiting certain uses of EtO where alternatives exist, such as in museums, archival settings, beekeeping, some cosmetics, and musical instruments. Facilities would be required to reduce the amount of EtO used for medical device sterilization, while still meeting applicable standards to ensure sterility, and to implement engineering controls to reduce worker exposures. Workers in commercial sterilization facilities would be required to use personal protective equipment if monitoring technology detects EtO emissions greater than 10 parts per billion (ppb). EPA’s proposal sets different timelines for implementing these controls, given their varied complexity and feasibility.

These new measures follow EPA’s request for information on EtO emissions from 31 facilities in the commercial sterilization sector, which was issued in October 2021. The agency also encourages stakeholders in the community, industry, and public health to provide comments on the proposed standards and attend a public webinar on May 1, 2023, at 8 p.m. Eastern time. More information, including on how to submit comments and register for the webinar, can be found in EPA’s press release and EtO webpage.

Related: An industrial hygienist from a consulting firm that participated in the sampling of EtO in the Willowbrook, Illinois, community discussed his experiences as part of a prerecorded virtual session at AIHce EXP 2020. The case drew national attention and resulted in the shuttering of a Willowbrook facility.