On September 21, 2026, the US Department of Justice (DOJ), Environment and Natural Resources Division, lodged a proposed consent decree with the US District Court for the District of Puerto Rico in United States v. Steri-Tech, Inc. (Civil Action No. 3:25-cv-01319), published in the Federal Register on September 25, 2026 (91 FR 60981). The decree resolves a Clean Air Act complaint over ethylene oxide (EtO) emissions from the defendant's sterilization facility in Salinas, Puerto Rico, requiring a $700,000 civil penalty and compliance with a 99.99% EtO removal efficiency standard.
Commercial EtO sterilization facilities, medical-device manufacturers operating on-site EtO chambers, and other Subpart O sterilization operators in Puerto Rico and the US mainland must immediately audit their own EtO emission controls and destruction/removal efficiency against the 99.99% benchmark DOJ enforced here, or face civil penalties and court-ordered injunctive relief under the same Clean Air Act sterilizer regime.
- Authority : US Department of Justice, Environment and Natural Resources Division (Environmental Enforcement Section)
- Entity : Steri-Tech, Inc.
- Measure and amount : proposed consent decree, $700,000 civil penalty and injunctive relief
- Legal basis : Clean Air Act (42 U.S.C. 7401 et seq.); 40 CFR Part 63, Subpart O (NESHAP for Ethylene Oxide Commercial Sterilization and Fumigation Operations)
- Decision date : lodged September 21, 2026; published September 25, 2026
- Public comment period : 30 days from the September 25, 2026 publication, on the decree's court entry
- Official source : Federal Register notice, 91 FR 60981
What happened
DOJ filed the lawsuit under the Clean Air Act, seeking injunctive relief and civil penalties for violations of the regulations governing EtO emissions from Steri-Tech's Salinas, Puerto Rico sterilization facility. The proposed consent decree, lodged on September 21, 2026 and noticed in the Federal Register on September 25, 2026, requires the company to achieve a 99.99% EtO removal efficiency standard and pay a $700,000 civil penalty. Publication opens a 30-day public comment period before the court enters the decree, and the decree may be examined on the DOJ Environment and Natural Resources Division consent decrees page.
The breach
The complaint enforces the Clean Air Act's National Emission Standards for Hazardous Air Pollutants for EtO commercial sterilization and fumigation operations, codified at 40 CFR Part 63, Subpart O. As the Federal Register notice states, "The Consent Decree requires the defendant to perform injunctive relief (compliance with a 99.99% removal efficiency standard for ethylene oxide) and pay a $700,000 civil penalty." The 99.99% removal benchmark is the operative compliance threshold DOJ imposed.
Who else is in the same regime
The decree is the latest in a series of Clean Air Act enforcement actions against commercial EtO sterilizers under EPA and DOJ's National Compliance Initiative. Prior consent decrees include Sterigenics (Willowbrook, Illinois, 2019, $400,000) and Becton Dickinson (Covington, Georgia and El Paso, Texas, 2024, $451,000). EPA strengthened the Subpart O NESHAP in 2024, tightening EtO emission limits and destruction efficiency requirements for the regulated cohort of contract sterilizers and on-site medical-device sterilizers.
The exposed actors are the other facilities in that regime: commercial contract sterilizers, medical-device and equipment manufacturers running on-site EtO chambers, and other Subpart O operators selling sterilized products into US commerce from Puerto Rico or the mainland. Steri-Tech is the sanctioned entity, not the audience.
What to check now
- Audit EtO emission controls and the destruction/removal efficiency of chamber and aeration devices against the 99.99% standard DOJ enforced against Steri-Tech.
- Verify compliance with the strengthened 2024 Subpart O NESHAP amendments, including fugitive EtO emission limits and monitoring.
- Review EtO continuous emissions monitoring, parameter monitoring, and recordkeeping required under Subpart O.
- Check technical documentation of destruction device performance, batch logs, and ventilation for chambers and aeration rooms.
- Confirm reporting and notification duties under the Clean Air Act sterilizer regime are current.
- Brief EHS, legal, and operations leads on the enforcement trend and the 99.99% removal benchmark as the de facto settlement standard.
Obsidian's continuous, per-jurisdiction monitoring surfaces EtO sterilizer enforcement the moment it publishes.
