The Justice Department, on behalf of the Environmental Protection Agency (EPA), lodged a proposed settlement agreement with medical equipment sterilizer Steri-Tech Inc. yesterday to resolve allegations that it violated the Clean Air Act and related federal and Commonwealth of Puerto Rico regulations at its Salinas, Puerto Rico, sterilization facility. Under the proposed settlement, Steri-Tech will pay a $700,000 civil penalty and destroy its emissions of ethylene oxide by 99.99%.
The Justice Department’s June 2025 complaint alleged that, since at least June 2019, Steri-Tech failed to comply with levels of ethylene oxide emission control required by federal regulations and its operating permit issued by Puerto Rico. The complaint alleged that Steri-Tech failed to properly operate its thermal oxidizer, a pollution control device designed to incinerate hazardous air pollutants. Since the complaint was filed, Steri-Tech, working under EPA oversight, has brought its operations into compliance with the law.
“This settlement illustrates the federal government’s commitment to protecting local communities from toxic air pollution through tough enforcement against companies that fail to comply with the law,” said Principal Deputy Assistant Attorney General Adam Gustafson of the Justice Department’s Energy and Natural Resources Division (ENRD). “Steri-Tech’s commitment to implement control its emission of EtO supports President Trump’s effort to protect children from toxic air emissions and to make America healthy again.”
“EPA is committed to protecting people from hazardous air pollutants such as ethylene oxide, which is widely used to sterilize medical devices that are essential for the care of children, older adults, and other patients,” said Assistant Administrator Jeffrey Hall for EPA’s Office of Enforcement and Compliance Assurance. “While these facilities themselves provide a service that protects people, EPA’s job is to make sure that the facilities have the proper controls to support safe access to critical medical devices while reducing exposure for communities.”
“One of the mission priorities of the U.S. Attorney’s Office is to ensure compliance with the nation’s environmental laws and working with our EPA partners to ensure that individuals and corporations remain in compliance. This agreement achieves that,” said Acting U.S. Attorney Héctor Ramírez-Carbó for the District of Puerto Rico. “The U.S. Attorney’s Office will continue to work with our federal, state, and local partners to investigate and hold accountable those that violate our laws and place our communities in jeopardy.”
“This proposed agreement resolves Steri-Tech’s past violations under the Clean Air Act and ensures the facility in Salinas, Puerto Rico continues to operate in compliance of federal laws,” said EPA Region 2 Administrator Michael Martucci. “The nation-leading limit on ethylene oxide emissions will reduce exposure for nearby residents.”
Ethylene oxide (EtO) is a listed hazardous air pollutant under the Clean Air Act and has been characterized as carcinogenic to humans by inhalation exposure. EtO is a flammable, colorless gas with a somewhat sweet odor when present at very high levels. EtO gas is used to sterilize medical and dental devices that cannot be sterilized using steam or radiation. Approximately 50% of sterile medical devices in the United States are treated with EtO — about 20 billion devices each year.
The proposed consent decree was lodged in the U.S. District Court for the District of Puerto Rico. The settlement is subject to a 30-day comment period and final court approval. The consent decree will be available for viewing on the Justice Department’s website at www.justice.gov/enrd/consent-decrees .
Attorneys from ENRD’s Environmental Enforcement Section are handling the case in conjunction with EPA.
Source: U.S. Attorney’s Office — Puerto Rico — U.S. Department of Justice press release.