Medical Equipment Sterilizer Agrees to Limit Ethylene Oxide Emissions

Medical equipment sterilizer Steri-Tech Inc. yesterday resolved allegations that it violated the Clean Air Act and related U.S. federal and Commonwealth of Puerto Rico regulations at its sterilization facility on the island. Under the proposed settlement agreement with the U.S. Justice Department—which acted on behalf of the U.S. Environmental Protection Agency—Steri-Tech will pay a $700,000 civil penalty and reduce its ethylene oxide (EtO) emissions by 99.99%. 

“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 controls on its emission of EtO supports President Trump’s effort to protect children from toxic air emissions and to make America healthy again.”

Since at least June 2019, Steri-Tech allegedly failed to comply with EtO emission levels required by federal regulations and its operating permit issued by Puerto Rico, according to the Justice Department’s June 2025 complaint. Federal prosecutors claim 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 at the Salinas, Puerto Rico, facility into compliance.

“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,” stated 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.”

Related: FDA Encourages Vaporized Hydrogen Peroxide as Possible EtO Alternative

Ethylene oxide 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 U.S. medical devices are treated with EtO—about 20 billion products annually. 

“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,” commented 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 who 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.” 

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.

Attorneys from ENRD’s Environmental Enforcement Section are handling the case in conjunction with EPA.