What: On March 17, 2026, the U.S. Environmental Protection Agency (EPA) announced a reconsideration of Ethylene Oxide (EtO) standards for commercial sterilization facilities.
Why: Under the Clean Air Act (CAA), the EPA is required to set standards for hazardous air pollutants. In addition, the agency is also required to review and revise the standards “as necessary” at least every eight years to address developments in practices, processes, and control technologies.
In 2006, the EPA held that existing EtO standards for commercial sterilization facilities adequately protected public health with an ample margin of safety and, separately, concluded that no further revisions were “necessary” given the minimal emission reductions and high costs associated with available control strategies.
However, in 2024, the EPA, for the first time, conducted a “discretionary” review of the EtO standards and considerably tightened the regulations for commercial sterilization facilities. When these standards were proposed, Advocacy warned that they “would lead to a significant number of small entities leaving the market for commercial sterilization, harming small medical device manufacturers, causing significant supply chain disruptions, and hurting patients needing sterilized medical devices.”
The EPA is now proposing to rescind and revise the 2024 rule. Specifically, the proposed rule would:
- Revise the standard for new aeration room vents at facilities using at least 10 tons per year of EtO.
- Amend the compliance demonstration requirements to allow facilities to choose between parametric monitoring or a continuous emission monitoring system.
- Rescind the requirement that permanent total enclosure be used to ensure complete capture of EtO.
The following categories of small businesses may be impacted by the proposed rule:
- Surgical and medical instrument manufacturing.
- Surgical appliance and supplies manufacturing.
- Pharmaceutical preparation manufacturing.
- Spice and extract manufacturing.
- Dried and dehydrated food manufacturing.
- Packaging and labeling services.
The EPA estimates that the proposed rule would reduce costs over the 2026 to 2046 timeframe of about $43 and $48 million per year at discount rates of 3 percent and 7 percent, respectively.
Action: Read the proposed revisions and submit comments before the May 1, 2026, deadline.
A virtual public hearing on the proposed rule will be held on April 1, 2026.
FEDERAL REGISTER NOTICE:
PUBLIC HEARING REGISTRATION:
Proposed amendments to the?National Emission Standards for Hazardous Air Pollutants (NESHAP)
CONTACT:
Nick Goldstein
EMAIL:
Regulatory Alerts
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