Current Status
In 2024, the Biden EPA finalized a rule to reduce emissions of ethylene oxide (EtO), a potent carcinogen, from chemical sterilizers by 92 percent. The rule was immediately challenged, but the D.C. Circuit is holding the litigation in abeyance in response to a motion by the Trump administration.
In March 2025, the Trump administration invited industry to seek exemptions from the rule. Two trade associations requested exemptions for all members, potentially covering 88 facilities.
Why it Matters
Ethylene Oxide (EtO) is a flammable, colorless gas that is used primarily as a sterilizer for medical devices. Despite the widespread use of EtO, chronic exposure to the gas has been linked to reproductive and developmental harm, including an increased risk of miscarriage, and an increased risk of several different types of cancer, including lymphoid and breast cancer. Children and babies are more susceptible to harm from the chemical.
Over 14.2 million people live within five miles of an EtO-emitting facility in the United States. A 2023 study found that the average risk of cancer from air toxics was nearly three times the national average in communities located near EtO-emitting facilities. According to a 2021 EPA study, nearly two-thirds of the EtO-emitting facilities contributing to cancer risks of 100 in one million or more are in census block groups that are at least 50 percent minorities or low-income households.
Key Resources
Timeline
March 27, 2025 The Trump Administration invited industry to seek exemptions from the 2024 rule. On March 31, The American Chemistry Council (ACC) requested a two-year exemption for all its members. Those exemptions could cover 88 EtO-emitting facilities.
March 25, 2025 EPA filed a motion renewing its request to hold the litigation in abeyance and requested the court remand the case to EPA to reconsider the rule. California Communities Against Toxics et al. filed a motion in opposition and The Ethylene Oxide Sterilization Association, Inc. filed a motion in support of EPA. On April 1, the court granted the motion to hold the case in abeyance, removed the case from the oral argument schedule, and directed EPA to file a status report on June 30, but did not remand the rule to EPA. California Communities Against Toxics, et al. v. EPA, et al., Docket No. 24-1178 (D.C. Cir. June 3, 2024).
March 12, 2025 EPA Administrator Zeldin announced the agency will reconsider multiple NESHAPs affecting various industrial sectors, including rules regulating commercial sterilizers for medical devices. On March 21, EPA sent a letter to the Ethylene Oxide Sterilization Association announcing it is reconsidering the 2024 rule, including EPA’s authority and decision to undertake a second residual review under CAA Section 112(f)(2) and the resulting risk standards; the promulgated standards; and the requirement to demonstrate compliance through continuous monitoring.
Feb. 18, 2025 EPA filed a motion to hold the case in abeyance. On Feb. 21, without addressing the request for abeyance, the court scheduled oral argument for April 15. EPA filed a motion defending the Biden rule on Feb. 24. California Communities Against Toxics et al. v. EPA, et al., Docket No. 24-1178 (D.C. Cir. June 3, 2024).
Jan. 16, 2025 In a White House Memorandum, President Biden detailed a process for commercial sterilizers to request waivers from EPA’s EtO rule. The process was intended to provide an avenue for sterilizers to ensure a reliable supply of safe medical products in the interest of public health and national security.
April 5, 2024 EPA published a final rule setting emissions standards for ethylene oxide (EtO) emissions from chemical sterilizers. Two groups, led by California Communities Against Toxics (with other environmental NGOs) and The Ethylene Oxide Sterilization Association (with other organizations representing industry), submitted petitions for review to the D.C. Circuit. On June 5, the court consolidated both cases under California Communities Against Toxics et al. v. EPA, et al., Docket No. 24-1178 (D.C. Cir. June 3, 2024).