EPA and DOJ Reach $700,000 Settlement with Puerto Rico Sterilizer Over Clean Air Act Violations
WASHINGTON – Today, U.S. Environmental Protection Agency (EPA) and the U.S. Department of Justice (DOJ) announced a proposed settlement agreement with commercial sterilization facility operator Steri-Tech, Inc. to reduce ethylene oxide (EtO) emissions at its facility in Salinas, Puerto Rico, by 99.99% and pay a $700,000 fine to resolve past violations of the Clean Air Act. The settlement reduces toxic EtO exposure for nearby residents in Salinas, Puerto Rico.
“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 for the Office of Enforcement and Compliance Assurance Jeffrey Hall. “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.”
“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.”
“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.”
Under the proposed consent decree, Steri-Tech would be required to continuously reduce EtO emissions by at least 99.99% from each sterilization chamber vent at the facility. Steri-Tech presently operates in compliance with this requirement under EPA oversight.
The proposed consent decree was filed September 21 with the U.S. District Court for the District of Puerto Rico and is subject to a 30-day comment period. The complaint and the proposed consent decree are available on the Justice Department’s Proposed Consent Decree webpage.
Background
EtO is a colorless gas that is critical to the medical device supply chain. Commercial sterilization covers the sterilizer processes that use EtO to sterilize or fumigate materials such as medical equipment and supplies, spices, and other miscellaneous products and items. These processes are designed to eliminate microorganisms including bacteria, viruses, fungi, and protists from products to ensure they are safe for human use and consumption. Each year, EtO is used to sterilize approximately 20 billion medical devices, or about 50 percent of all U.S. medical devices.
EPA is focused on taking actions that will save lives and protect Americans from exposure to excess EtO emissions. The DOJ-EPA June 2025 complaint in this matter alleged, among other things, that Steri-Tech improperly operated its thermal oxidizer, a pollution control device designed to incinerate hazardous air pollutants such as EtO, since at least June 2019, failing to comply with levels of EtO emission control required by federal regulations and its operating permit issued by Puerto Rico. Since the complaint was filed, Steri-Tech working under EPA oversight has brought its operations into compliance with the law.
Please see EPA’s efforts to address EtO for more information.