PUERTO RICO MEDICAL STERILIZER AGREES TO $700,000 CLEAN AIR ACT SETTLEMENT AND 99.99% ETHYLENE OXIDE DESTRUCTION STANDARD

SALINAS, P.R. — A Puerto Rico medical equipment sterilization company has agreed to pay a $700,000 civil penalty and operate under stringent ethylene oxide emission controls to resolve federal allegations that its Salinas facility violated the Clean Air Act and related Puerto Rico air-quality requirements.

The Justice Department, acting on behalf of the Environmental Protection Agency, lodged the proposed consent decree with the U.S. District Court for the District of Puerto Rico on September 21. DOJ said Steri-Tech has brought its operations into compliance with the law under EPA oversight. The proposed decree separately requires the facility to continuously reduce ethylene oxide emissions by at least 99.99% from each sterilization chamber vent.

The settlement resolves allegations contained in a federal complaint filed in June 2025. Prosecutors alleged that Steri-Tech had failed since at least June 2019 to meet required ethylene oxide emission-control levels established under federal regulations and the company’s Puerto Rico operating permit.

The government alleged that Steri-Tech failed to properly operate a thermal oxidizer, a pollution-control device designed to incinerate hazardous air pollutants.

The case is a civil enforcement matter. Steri-Tech does not admit and specifically denies liability for the conduct alleged in the federal complaint, and the proposed consent decree states that the negotiated resolution is not an admission or adjudication of liability.

Under the proposed decree, Steri-Tech will pay the $700,000 penalty in two installments. Court records show that $350,000 is due within 30 days after the decree becomes effective, with the remaining $350,000 due within one year. Interest will accrue from the date the consent decree was lodged with the court.

EPA described the 99.99% standard as a nation-leading emission-control limit intended to reduce exposure for residents near the Salinas facility. Under the proposed decree, Steri-Tech must continuously reduce ethylene oxide emissions by at least 99.99% from each sterilization chamber vent, subject to limited maintenance-day provisions established in the agreement.

Ethylene oxide, commonly abbreviated as EtO, is a flammable and colorless gas used extensively to sterilize medical and dental equipment that cannot be sterilized using steam or radiation.

The chemical is classified as a hazardous air pollutant under the Clean Air Act and has been characterized as carcinogenic to humans through inhalation exposure.

Its industrial role is significant.

EPA estimates that ethylene oxide is used to sterilize approximately 20 billion medical devices every year, accounting for roughly half of all sterile medical devices used in the United States.

The federal case, United States of America v. Steri-Tech, Inc., was filed in the District of Puerto Rico under the Clean Air Act’s federal enforcement provisions. The case was docketed as Civil Case No. 3:25-cv-01319-ADC.

Since the filing of that complaint, EPA says Steri-Tech has worked under agency supervision to bring its operations into compliance.

The settlement now seeks to convert those corrective measures into enforceable federal obligations.

If approved and entered by the court, the consent decree will become judicially enforceable, and the court will retain jurisdiction over disputes and compliance with its terms.

The proposed agreement also addresses future operations rather than only imposing a penalty for past conduct.

Continuous compliance with the 99.99% destruction requirement is intended to limit the amount of ethylene oxide released during sterilization operations and establish a measurable performance standard for the facility.

EPA Assistant Administrator Jeffrey Hall said the agency’s role is to ensure sterilization facilities use adequate pollution controls while preserving safe access to medical devices. EPA Region 2 Administrator Michael Martucci said the Salinas agreement establishes an especially stringent emission-control requirement intended to reduce exposure for nearby residents.

Acting U.S. Attorney Héctor Ramírez-Carbó for the District of Puerto Rico said environmental enforcement remains one of the office’s priorities and emphasized coordination among federal and local authorities to enforce environmental laws.

Attorneys from the Justice Department’s Energy and Natural Resources Division, Environmental Enforcement Section, are handling the case in coordination with EPA.

The proposed consent decree remains subject to a 30-day public comment period and final approval by the federal court.

Until that process is complete, the agreement is proposed rather than final.

If approved, Steri-Tech will be legally bound to the $700,000 civil penalty and the continuing 99.99% ethylene oxide emission-reduction requirement established by the proposed consent decree.

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United States of America v. Steri-Tech, Inc., Proposed Consent Decree, U.S. District Court for the District of Puerto Rico, Civil Case No. 3:25-cv-01319-ADC, filed September 21, 2026. (Free Download)

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