Breaking News: EPA Implements Groundbreaking Measures to Reduce Ethylene Oxide Emissions and Cancer Risk

March 14, 2024

WASHINGTON – Today marks a significant milestone in the pursuit of public health and environmental justice, as the U.S. Environmental Protection Agency (EPA) unveils a final rule aimed at drastically reducing toxic emissions of ethylene oxide (EtO) from commercial sterilization facilities nationwide. EtO, recognized as one of the most potent cancer-causing chemicals, poses a significant risk to communities living near these facilities. Through the implementation of rigorous air pollution controls, this rule mandates a reduction of over 90% in EtO emissions, setting a new standard for environmental protection in the United States.

This monumental rule not only aligns with President Biden’s ambitious Cancer Moonshot initiative but also underscores the Biden-Harris Administration's commitment to safeguarding the health and well-being of communities disproportionately affected by toxic pollutants. Particularly vulnerable are children and marginalized communities already burdened by environmental hazards. By finalizing this rule, the EPA has prioritized public health, leveraging the latest scientific data and insights to formulate stringent yet achievable standards for commercial sterilization facilities.

EPA Administrator Michael S. Regan emphasized the agency's dedication to following scientific evidence and listening to community concerns in shaping this rule. He highlighted the imperative of protecting vulnerable populations, including children, from carcinogenic pollutants like EtO. The EPA's collaboration with various stakeholders, including the Department of Health and Human Services, underscores a coordinated effort to prioritize public health while ensuring the reliability of medical sterilization supplies.

The rule’s development involved extensive outreach and engagement with communities and stakeholders, with the EPA soliciting feedback through public hearings, national webinars, and regional meetings. The robust response, including over 40,000 comments, informed the final rule and underscored the urgent need for enhanced health protections. Strengthened standards and improved risk assessments reflect the EPA's commitment to addressing community concerns and mitigating risks effectively.

The final rule encompasses several key provisions, including:

• Establishing standards for previously unregulated emissions such as building leaks and chamber exhaust vents.
• Strengthening existing standards for sources like sterilization chamber vents and aeration room vents.
• Requiring continuous emissions monitoring and quarterly reporting for enhanced transparency and accountability.
• Ensuring emission standards apply during all operational phases to maintain consistent protection of public health.

Moreover, the Biden-Harris Administration recognizes the critical importance of securing the medical device supply chain. To this end, provisions are in place to provide compliance exemptions in special circumstances to prevent disruptions while facilities work towards meeting emission standards.

This landmark rule is part of a broader strategy to reduce EtO exposure, with additional actions planned to address emissions from chemical plants and other sources. The EPA's commitment extends beyond regulatory measures to encompass ongoing research, enforcement, and collaboration with stakeholders to advance public health and environmental protection.

For further details on the EPA's Final Amendments to Strengthen Air Toxics Standards for Ethylene Oxide Commercial Sterilizers, please visit the EPA website.

As we move forward, the EPA remains steadfast in its commitment to safeguarding public health and advancing environmental justice, underscoring the vital intersection between environmental protection and human well-being. Today’s announcement heralds a new era of environmental stewardship, where science, community engagement, and regulatory action converge to create a safer, healthier future for all.