Steri-Tech Inc. has agreed to pay a $700,000 civil penalty and accept stricter controls on ethylene oxide emissions at its Puerto Rico medical-equipment sterilisation facility under a proposed settlement of alleged Clean Air Act violations.
The consent decree, lodged in the US District Court for the District of Puerto Rico, would require Steri-Tech to continuously reduce ethylene oxide emissions by at least 99.99% from each sterilisation-chamber vent at its facility in Salinas.
The agreement remains subject to a 30-day public comment period and court approval. Steri-Tech Sandoz $450M Antitrust Settlement — Lawyer Monthly under the settlement, and the decree states that it should not be treated as an adjudication or admission of the allegations made by the US government.
The US Department of Justice lodged the agreement on behalf of the Environmental Protection Agency following enforcement proceedings launched in June 2025.
The government alleged that, from at least June 2019, Steri-Tech failed to achieve the required levels of ethylene oxide emissions control under federal regulations and the operating permit issued for its Puerto Rico facility.
At the centre of the allegations was the operation of Steri-Tech’s thermal oxidiser, equipment designed to destroy hazardous air pollutants before they are released.
EPA said Steri-Tech has since brought the facility into compliance while operating under agency oversight.
The proposed decree would make continuing emissions controls legally enforceable. Steri-Tech would have to maintain the 99.99% reduction requirement for each sterilisation-chamber vent, subject to limited designated maintenance days, and comply with specified operating and monitoring parameters for its pollution-control equipment.
The company must also submit quarterly compliance information to EPA and DOJ, including operational and monitoring data and details of any non-compliance. Certain temperature-monitoring information relating to the thermal oxidiser must also be published on Steri-Tech’s website.
Ethylene oxide, or EtO, is regulated as a hazardous air pollutant under the Clean Air Act and is widely used to sterilise medical equipment that cannot be treated using other methods.
EPA says approximately 20 billion medical devices — around half of all sterile medical devices used in the United States — are sterilised with ethylene oxide each year.
That dependence creates a significant compliance issue for commercial sterilisation businesses. The industrial process remains important to the medical-device supply chain, but facilities must operate emissions-control systems within federal and permit requirements.
The Steri-Tech agreement therefore goes beyond payment of a civil penalty. It combines financial sanctions with operational controls, monitoring, reporting and continuing EPA oversight.
The $700,000 penalty would be paid in two instalments of $350,000. The first would be due within 30 days of the decree taking effect and the second within one year, with interest accruing from the date the agreement was lodged with the court.
For environmental lawyers and regulated businesses, the case illustrates how compliance depends on more than simply installing Mercedes-Benz and Leigh Day Consider Appeal | Lawyer Monthly. Companies must also demonstrate that equipment is being operated, monitored and maintained at the performance levels required by permits and California Signs Seven New Data Centre Laws | Lawyer Monthly.
The reporting obligations are significant for the same reason. Once incorporated into a consent decree, operating parameters and monitoring requirements become enforceable court obligations, potentially exposing a company to further penalties if it fails to comply.
The proposed settlement also shows the role of remedial action after enforcement begins. Steri-Tech is already operating in accordance with the enhanced emissions requirement, but court approval would convert those controls into continuing legal obligations.
If approved, the decree would resolve the federal government’s Clean Air Act allegations while imposing both the $700,000 penalty and an ongoing compliance regime at Steri-Tech’s Salinas facility.