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In August 2022 Cal/OSHA opened an investigation, and later issued 18 citations, including six citations for willful-serious violations, to Parter Medical Products, Inc. in Carson California for failing to protect its employees from overexposure to ethylene oxide (EtO), a toxic chemical. The proposed penalties totaled $838,800. It’s inspection showed “this was not an isolated incident of chemical overexposure to workers. Parter Medical Products, Inc. dba Parter Sterilization Services was founded in 1984, and uses ethylene oxide gas to sterilize medical devices.

The Carson City Council unanimously voted in early 2022 to request air monitors be placed in various locations of the city to monitor air quality. South Coast AQMD was further investigating EtO emissions in the nearby residential communities and the agency was working with the City of Carson to identify additional locations to collect 24-hour samples in the nearest community and school. So far, data from residential monitors show EtO levels to be within typical background levels.

And now on March 14, 2024 the U.S. Environmental Protection Agency announced a rule that will reduce lifetime cancer risks for people living near commercial sterilization facilities across the country. The final amendments to the air toxics standards for ethylene oxide commercial sterilization facilities put in place the strongest measures in U.S. history to reduce emissions of EtO, one of the most potent cancer-causing chemicals. Through the installation of proven and achievable air pollution controls, commercial sterilizers will reduce emissions by more than 90%.

In finalizing this rule, EPA considered the latest data and science, while taking into account the importance of a safe and reliable supply of medical sterilization devices for patients and hospitals. EPA worked closely with partners  including at the Department of Health and Human Services, to develop a final rule that centers on public health. The EPA claims that this final rule provides sufficient time and flexibility for facilities to come into compliance, simultaneously affording strong public health protection for nearby communities while minimizing any potential impacts to the medical device supply chain.

In developing the final rule, EPA conducted extensive outreach to communities and stakeholders to ensure meaningful and extensive participation during the public comment period. EPA conducted public hearings, national webinars, and public meetings hosted by regional EPA offices. The considerable feedback received from the three days of public hearings, as well as the more than 40,000 comments submitted to the rulemaking docket, both informed the final rule and demonstrated the strong need to issue these vital health protections. Based on this input, EPA improved the risk assessment and strengthened the standards to ensure risk reductions for surrounding communities.

The final rule will address emissions at nearly 90 commercial sterilization facilities that are owned and operated by approximately 50 companies. Based on extensive input and review, EPA is finalizing the following amendments to the National Emission Standards for Hazardous Air Pollutants that:

  • Establish standards for currently unregulated emissions, such as building leaks (“room air emissions”) and chamber exhaust vents, to reduce cancer risk and account for technological developments in pollution control.
  • Strengthen standards that are on the books for sources such as sterilization chamber vents and aeration room vents.
  • Require continuous emissions monitoring and quarterly reporting for most commercial sterilizers that will provide communities, states, Tribes, and local governments, and EPA with data to ensure EtO emissions are not entering the outdoor air.
  • Ensure that sterilizers are subject to emission standards during periods of startup, shutdown, and malfunction so there is continuous clean air protection.
  • Other clarifying items including electronic reporting and technical revisions.

This final rule for commercial sterilizers is one of a series of coordinated actions that EPA is taking to reduce exposure to EtO. Under the Federal Insecticide, Fungicide, and Rodenticide Act, EPA’s Office of Pesticide Programs is also working on a comprehensive set of new mitigation measures for EtO to reduce exposure for workers who use EtO to sterilize products. EPA has been working to support alignment of today’s Clean Air Act rule with the action being taken under FIFRA.

EPA is also working to strengthen standards to reduce EtO and other toxic pollutants from chemical plants. Other actions to address EtO emissions and advance EtO research include:

  • Investigating additional sources of EtO (e.g., stand-alone warehouses) and opportunities for emissions controls.
  • Enforcing existing regulations as appropriate.
  • Conducting research to better understand and measure EtO.

For more information, visit EPA’s Final Amendments to Strengthen Air Toxics Standards for Ethylene Oxide Commercial Sterilizers webpage.