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UPDATED: GASP Lauds Finalization of EPA Rule to Slash Toxic Emissions of Ethylene Oxide & Reduce Cancer Risk

Updated: Apr 5

Editor's Note: The EPA on April 5, 2024, finalized its ethylene oxide rule, which is effective immediately.

The U.S. Environmental Protection Agency on Thursday announced a rule that will reduce lifetime cancer risks for people living near commercial sterilization facilities across the country.

Two such facilities are right here in southwestern Pennsylvania - American Contract Systems, Inc., in Zelienople, Butler County, and Cosmed Group LLC/Erie in the City of Erie.  

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 ethylene oxide, 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%.

“We appreciate the resources and effort that go into updating a risk assessment and are glad that work led to a rule that will help protect people living near industrial facilities from a very real cancer risk,” GASP Executive Director Patrick Campbell said. “This is a win for residents in Zelienople, Erie, and beyond living near these sterilization facilities.”

EPA in finalizing the rule considered the latest data and science - including risk assessments conducted at both Pennsylvania facilities - while taking into account the importance of a safe and reliable supply of medical sterilization devices for patients and hospitals. 

In developing the final rule, which GASP senior attorney John Baillie broke down in a watchdog report this past April, the 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 the agency's regional 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 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

EPA said this final rule for commercial sterilizers is one of a series of coordinated actions it 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 ethylene oxideto 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 ethylene oxide and other toxic pollutants from chemical plants. Other actions to address ethylene oxide emissions and advance associated research include:

  • Investigating additional sources of ethylene oxide (e.g., stand-alone warehouses) and opportunities for emissions controls.

  • Enforcing existing regulations as appropriate.

  • Conducting research to better understand and measure ethylene oxide

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