US Enters Legal Agreement Requiring EPA to Finalize Ethylene Oxide Rule by March

The United States has entered into a legal agreement that compels the Environmental Protection Agency (EPA) to finalize the Ethylene Oxide (EtO) rule by March. This development stems from a lawsuit filed by multiple groups in the previous year, accusing the EPA of neglecting its responsibility to "review and revise the air toxics standards for commercial sterilizers." While the EPA has proposed more stringent regulations regarding the release of the toxic chemical ethylene oxide, the definitive rules are still pending.

The consent decree, which was made available for public input earlier this year, binds the EPA to complete the rulemaking process by March 1. However, some stakeholders, including a medical technology trade group, have expressed reservations about the feasibility of this timeline considering the "substantial" remaining work. The deadline imposed by the decree has been criticized for being "inadequate" and not allowing sufficient time for comprehensive analysis, regulatory drafting, and interagency policy coordination.

The basis of the lawsuit lies in the fact that it had been 16 years since the EPA established ethylene oxide emissions standards for sterilization facilities. Citing legislation mandating a review and revision of standards "no less often than every 8 years," the plaintiffs pushed for the prompt release of new air toxic standards.

The result of the legal action was the formulation of a consent decree, which underwent a consultation period earlier this year. Following the collection of feedback, the U.S. government has now ratified the decree, binding the EPA to produce a final rule that incorporates all "necessary" revisions by the specified deadline. While the possibility of an extension exists, it can only occur through a written agreement between the parties with notice to the court or by a court decision based on an EPA motion with just cause. Moreover, a lack of funding for the EPA in the 120 days leading up to the deadline could also trigger an extension.

The proposed rule by the EPA includes an 18-month transition period, suggesting that the industry will need to implement pollution controls by September 1, 2025.

Concerns have been raised within the medical technology sector regarding the timeline and emissions targets set forth by the EPA. MDMA contends that the EPA requires more than 18 months to adequately address public comments. The consent decree allows the EPA eight months after the conclusion of the comment period to finalize the rule.

The draft rule has sparked differing opinions, with the medical device industry expressing apprehensions that the proposed measures could potentially lead to a reduction of 30% to 50% in total sterilization facility capacity per site. In contrast, occupational health groups have applauded the policy's potential to safeguard workers and community members from the adverse effects of ethylene oxide exposure.