EPA Releases Interim Decision for Ethylene Oxide to Reduce Cancer Risk

TL/DR –

The U.S. Environmental Protection Agency (EPA) has released an interim decision on Ethylene Oxide (EtO), a pesticide known to cause cancer and used on 50% of all sterilized medical devices and approximately 30% of dried herbs and spices in the U.S. The decision includes mitigation measures to reduce exposure to workers and nearby communities, such as lowered worker exposure limits, phased cancellation of its use on certain dried herbs and spices, and cancellation of its use when safer alternatives are available. The major measures include lower worker exposure limits by 2035, immediate cancellation for specific dried herbs and spices, establishing a concentration limit for new medical device sterilization cycles within 10 years, and continuous EtO concentration monitoring throughout sterilization facilities.

US EPA Takes Action Against Carcinogenic Pesticide Ethylene Oxide

Today, the U.S. Environmental Protection Agency (EPA) released the interim decision for Ethylene Oxide (EtO), a pesticide used on half of all sterilized medical devices and around 30% of dried herbs and spices in the U.S. Known for causing lymphocytic leukemia, breast cancer, non-Hodgkin lymphoma, and myeloma in humans, workers and individuals living near these facilities are at increased risk of cancer.

The interim decision incorporates measures to reduce exposure to workers and nearby communities in addition to the 2024 EtO National Emissions Standards for Hazardous Air Pollutants (NESHAP) measures. These actions will address EtO pollution concerns and increase safety for communities and workers, aligning with President Biden’s Cancer Moonshot commitment and the administration’s environmental justice and public health protection initiatives.

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

Understanding Ethylene Oxide

Regulated as a pesticide by EPA under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), EtO is used for sterilizing medical devices and fumigating dried herbs and spices. As part of the registration review, the agency assessed cancer risk from working or living near EtO facilities, and consuming EtO-treated dried herbs and spices.

After extensive public input and stakeholder meetings, EPA proposed broad protections under FIFRA to minimize exposure to EtO sterilization facility workers and those in nearby areas. This includes lowering EtO concentration rate limits, phased cancellation of EtO use on specific dried herbs and spices, and discontinuation of EtO use when safer alternatives become available.

Interim Decision Highlights

Key points of the Interim Decision include:

• Lowered worker exposure limits by 2035 compared to the 1984 OSHA limit.
• Ban on use for museum, library and archival materials; cosmetics; musical instruments; and beekeeping equipment.
• Cancellation of EtO use for specific dried herbs and spices not critical for food safety and phased cancellation for those critical for food safety but have potential alternatives.
• Required respiratory protection for workers involved in high EtO exposure tasks.
• Continuous EtO concentration monitoring in sterilization facilities and warehouses.

For healthcare facilities, the decision requires abatement devices for facilities that use more than 10 lbs. of EtO/year and ventilation of EtO through exterior stacks to reduce worker exposure.

What’s Next?

EPA expects registrants to submit label amendments reflecting the Interim Decision’s changes within 60 days after publication. The agency will promptly review these amendments. The implementation timing for individual mitigation measures ranges from two to 10 years, considering costs, technology availability, potential impacts on the medical device supply chain, and other logistical elements. Additionally, EPA will issue a Data Call-In to gather information on worker exposure and reevaluate this Interim Decision within eight years based on the submitted worker exposure data.

To view all documents related to EtO’s registration review, visit docket EPA-HQ-OPP-2013-0244.

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