WASHINGTON – Today, March 14, 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%.

EPA's Stringent Measures

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 across the Biden-Harris Administration, including at the Department of Health and Human Services, to develop a final rule that centers on public health. 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.

Key Stakeholder Involvement

“This final rule to sharply cut toxic emissions of ethylene oxide responds to the ambition set forth by President Biden’s Cancer Moonshot,” said EPA Administrator Michael S. Regan. “We have followed the science and listened to communities to fulfill our responsibility to safeguard public health from this pollution – including the health of children, who are particularly vulnerable to carcinogens early in life. We’ve arrived at a historically strong rule that will protect the most exposed communities from toxic air pollution while also ensuring that there will be a process that safeguards our nation’s critical supply of sterilized medical equipment.”

“For years, I have called for environmental justice, urging protections for workers and fenceline communities from the dangers of EtO pollution,” said Xavier Becerra, United States Secretary of Health and Human Services. “We will continue to work together with EPA to achieve our shared goals of lowering EtO exposure while also mitigating potential risks of medical device shortages.”

Community Outreach and Feedback

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.

Regulatory Amendments

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.

Preventing Unintended Consequences

To prevent unintended consequences and ensure orderly implementation, the Clean Air Act has long provided backstop authority allowing the President to provide a two-year compliance exemption to assist a facility with achieving compliance with National Emission Standards for Hazardous Air Pollutants in carefully delimited special circumstances — if the technology to implement the standard is not available and it is in the national security interest to provide additional time to comply. EPA has confirmed that the President is prepared to exercise this authority, if necessary to protect the medical supply chain and a commercial sterilizer is working in good faith to come into compliance with the rule.

Coordinated Actions

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.

Highlights

• The U.S. Environmental Protection Agency (EPA) has announced a final rule aimed at reducing toxic emissions of ethylene oxide (EtO) from commercial sterilization facilities, thereby lowering cancer risks for nearby communities.
• The rule implements stringent measures, including reducing EtO emissions by over 90%, to protect public health while ensuring a reliable supply of medical sterilization devices.
• Extensive stakeholder involvement, including community outreach and feedback, informed the final rule, which addresses emissions from nearly 90 facilities across the country.
• Key amendments to the National Emission Standards for Hazardous Air Pollutants include establishing standards for unregulated emissions, strengthening existing standards, and requiring continuous emissions monitoring.
• The rule provides measures to prevent unintended consequences and offers flexibility for compliance while safeguarding the medical supply chain.
• EPA's action is part of a broader effort to reduce EtO exposure, aligning with initiatives under other regulatory acts and emphasizing research and enforcement to address EtO emissions comprehensively.