What Is the New EPA Regulation for Ethylene Oxide and How Does It Affect You?

On January 14, 2025, the U.S. Environmental Protection Agency (EPA) finalized its Interim Registration Review Decision for ethylene oxide (EtO), a chemical critical for sterilizing medical equipment but also known to pose cancer risks. The decision includes stricter regulations aimed at reducing exposure to EtO for workers and surrounding communities.

This regulatory update signals a major shift in how industries using EtO must manage their operations. Here’s an overview of what’s happening, why it matters, and what steps your business should take to prepare.

What Is the EPA’s Decision on Ethylene Oxide Regulation?

The EPA’s decision introduces a suite of mitigation measures to reduce the risks associated with EtO exposure. Key updates include:

1. Worker Exposure Limits:
   • A progressive reduction of worker exposure limits from the current OSHA standard of 1 ppm to:
     • 0.5 ppm by 2028,
     • 0.25 ppm by 2030, and
     • 0.1 ppm by 2035.
   • Workers exposed to higher concentrations must now use additional respiratory protection.
2. Commercial Sterilizer Regulations:
   • New concentration limits for medical device sterilization cycles (max 600 mg/L unless justified by device design).
   • Continuous monitoring of EtO levels throughout sterilization facilities.
   • Separation of HVAC systems to limit EtO contamination in non-sterilization areas.
3. Healthcare Facility Requirements:
   • Facilities using over 10 lbs. of EtO annually must install abatement devices and ensure EtO is ventilated through exterior stacks.
   • Healthcare facilities are expected to emit significantly less EtO than commercial sterilizers, but safety protocols remain crucial.
4. Product and Usage Restrictions:
   • Immediate cancellation of EtO use for non-essential applications (e.g., museum artifacts, cosmetics).
   • Phased elimination of EtO for certain dried herbs and spices where alternatives exist.
5. Data Collection:
   • The EPA will require data submissions on worker exposure and sterilizer facility emissions to reassess this decision within eight years, earlier than the usual 15-year review cycle.

Why Does This Matter?

Ethylene oxide is a critical tool for sterilizing life-saving medical devices and ensuring food safety, but its use comes with significant risks. Here’s why this matters to businesses and communities:

• Health and Safety: EtO exposure is linked to severe health conditions, including lymphocytic leukemia, breast cancer, and other forms of cancer. Facilities that fail to meet exposure limits could face public backlash and regulatory action.
• Regulatory Compliance: The EPA’s stricter limits mean businesses must act now to upgrade detection systems, improve safety protocols, and invest in compliance solutions to avoid fines or operational shutdowns.
• Public Trust: As part of President Biden’s Cancer Moonshot initiative, this decision highlights the administration’s focus on environmental justice. Facilities that lead in compliance can build trust with their workers and communities.

Steps to Get Ahead

To ensure compliance and minimize risks, organizations using EtO must act proactively. Here’s how:

1. Upgrade Your Monitoring Systems:
   • Implement continuous EtO detection systems to meet the EPA’s new monitoring requirements. Look for solutions that offer real-time data and precise measurements, such as Interscan’s gas detection systems.
   • Ensure monitoring covers all critical areas, including storage facilities and sterilization zones.
2. Adapt to New Exposure Limits:
   • Evaluate current worker exposure levels and compare them to the upcoming limits (0.5 ppm by 2028, 0.25 ppm by 2030, and 0.1 ppm by 2035).
   • Provide additional respiratory protection for tasks that may exceed these limits.
3. Update Facility Infrastructure:
   • Separate HVAC systems for sterilization and non-sterilization areas to reduce cross-contamination.
   • Install abatement devices if your healthcare facility uses more than 10 lbs. of EtO annually.
4. Stay Informed and Involved:
   • Monitor EPA updates and submit feedback during public comment periods. Your input can shape future regulations.
   • Regularly review updates in the EPA’s EtO docket (EPA-HQ-OPP-2013-0244).
5. Educate Your Team:
   • Train employees on the updated regulations and the importance of following new safety measures.
   • Establish a clear plan to phase out non-critical EtO applications.

Final Thoughts

The EPA’s updated protections for EtO signal a new era of safety and accountability for industries using this essential yet hazardous chemical. Preparing now not only ensures compliance but also demonstrates a commitment to protecting workers and communities. By adopting advanced detection systems, updating infrastructure, and staying ahead of regulatory timelines, your organization can navigate these changes seamlessly.

For more details on the EPA’s Interim Decision, visit the EPA’s pesticide reevaluation page.