BOSTON (May 9, 2024) The U.S. Environmental Protection Agency (EPA) settled an administrative penalty case with Professional Contract Sterilization, Inc. (PCS) for alleged violations of Clean Air Act reporting requirements at their Ethylene Oxide sterilization facility in Taunton, Massachusetts.
The case was settled on February 6, 2024, with a Consent Agreement and Final Order with PCS agreeing to pay a settlement penalty of $15,000, an amount determined appropriate by EPA based on its review of the company’s financial ability to pay a penalty.
“We need to know if the air we’re breathing is safe!” said EPA Regional Administrator David W. Cash. “Tracking emissions and control measures from permitted facilities is one of the many important ways EPA ensures our loved ones are protected from harmful health issues – and our environment remains resilient.”
Ethylene oxide is a flammable, colorless and carcinogenic gas. Long-term human exposure to ethylene oxide has been linked to an increased risk of certain types of cancer, including leukemia and breast cancer. While ethylene oxide is primarily used to make other chemicals, such as antifreeze, it is also used as a sterilizing agent. According to the U.S. Food and Drug Administration, approximately 50 percent of sterile medical devices, or roughly 20 billion devices per year, are sterilized with ethylene oxide.
In April 2023, EPA proposed to significantly strengthen and update emissions standards for ethylene oxide emitted into the air from commercial sterilizers like PCS in order to reduce the long-term risks for workers at these sterilization facilities as well as people living in nearby communities.
In March 2024, EPA announced a rule that will reduce lifetime cancer risks for people living near commercial sterilization facilities across the country. The final amendments to the air toxics standards for ethylene oxide commercial sterilization facilities put in place the strongest measures in U.S. history to reduce emissions of EtO, one of the most potent cancer-causing chemicals. Through the installation of proven and achievable air pollution controls, commercial sterilizers will reduce emissions by more than 90%.
Background:
In September 2021, EPA issued an information collection request to commercial Ethylene Oxide sterilization facilities nationwide, including PCS, to determine whether these sterilizers contributed to elevated cancer risk for residents of surrounding communities. After PCS allegedly failed to provide the information, EPA issued a testing requirement in April 2022 directing the company to test its Ethylene Oxide sterilization facility’s emissions control system.
Subsequently, EPA filed an administrative complaint against the company in June 2022 alleging that PCS failed to submit information regarding its sterilization operation and to timely submit a plan to test whether its emissions control system was working properly. PCS completed its submission of the information requested in July 2022 after the complaint was filed and tested the performance of its emissions control system in April 2023. EPA staff was present during the performance test, reviewed the test results, and determined that PCS’s control systems were meeting the current control efficiency standards.
A copy of the Consent Agreement and Final Order can be provided upon request.