New EPA Measures Aim to Reduce Ethylene Oxide Exposure and Cancer Risk

Immediate bans on using EtO for cosmetics, musical instruments, and certain dried herbs.

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The U.S. Environmental Protection Agency (EPA) has issued its Interim Decision on ethylene oxide (EtO), a pesticide widely used to sterilize medical devices and fumigate dried herbs and spices. This decision is part of a broader effort to reduce cancer risks associated with EtO exposure while maintaining the availability of essential sterilized medical supplies.

Understanding the Risks of EtO

Ethylene oxide is a known carcinogen linked to several types of cancer, including lymphocytic leukemia, breast cancer, non-Hodgkin lymphoma, and myeloma. The National Institute for Occupational Safety and Health (NIOSH) conducted a study involving over 18,000 workers in commercial sterilization facilities, which found a significant association between EtO exposure and increased cancer risk.

Communities near EtO-emitting facilities also face elevated risks. A Union of Concerned Scientists report assessed 104 United States and Puerto Rico facilities, highlighting the potential health hazards for nearby residents.

Key Measures in the Interim Decision

The EPA’s Interim Decision introduces mitigation measures to protect workers and nearby communities. These measures complement the 2024 EtO National Emissions Standards for Hazardous Air Pollutants (NESHAP), forming a comprehensive strategy to address EtO-related pollution. The agency’s approach supports the Biden administration’s Cancer Moonshot initiative and its commitment to environmental justice and public health.

“EPA continues to make important strides to protect people from dangerous chemicals like ethylene oxide,” said Michal Freedhoff, Assistant Administrator for the Office of Chemical Safety and Pollution Prevention. “These protections will reduce EtO exposures to workers and communities while ensuring that the chemical remains available to provide sterile, life-saving medical supplies.”

Highlights of the Decision

Commercial Sterilizers

  • Reduced Worker Exposure Limits: A phased reduction to 0.5 ppm by 2028, 0.25 ppm by 2030, and 0.1 ppm by 2035—stricter than the current Occupational Safety and Health Administration (OSHA) standard of 1 ppm.
  • Targeted Bans and Restrictions: Immediate bans on using EtO for cosmetics, musical instruments, and certain dried herbs. Phased cancellations are planned for dried spices where alternatives exist.
  • Enhanced Safety Measures: Facilities must separate HVAC systems, continuously monitor EtO concentrations, and use respiratory protection for high-exposure tasks. Additionally, EtO application in sterilization cycles is capped at 600 mg/L unless justified by device design.

Healthcare Facilities

  • Ventilation Requirements: Facilities using over 10 pounds of EtO annually must install abatement devices and direct ventilation to exterior stacks, minimizing exposure risks.
  • Community Safety: Healthcare facilities pose less risk to nearby communities due to the significantly smaller quantities of EtO used than commercial sterilizers.

Next Steps and Implementation

The EPA has outlined a timeline for implementing these measures, ranging from two to ten years, considering costs, technological feasibility, and potential impacts on the medical device supply chain. Registrants are required to submit updated product labels reflecting these changes within 60 days. The EPA will also issue a Data Call-In to gather additional worker exposure data, which will inform future updates to the decision. The agency plans to revisit the Interim Decision within eight years, rather than the usual 15-year review cycle, to ensure continued progress in reducing EtO exposures.

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