The U.S. Environmental Protection Agency (EPA) has reached a settlement in an administrative penalty case with Professional Contract Sterilization, Inc. (PCS). The case was related to alleged violations of Clean Air Act reporting requirements at PCS's Ethylene Oxide sterilization facility in Taunton, Massachusetts.
The settlement, formalized on February 6, 2024, involves a Consent Agreement and Final Order where PCS agreed to pay a penalty of $15,000. The EPA determined this amount 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. It is primarily used to make other chemicals such as antifreeze but also serves 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, the EPA proposed strengthening and updating emissions standards for ethylene oxide emitted into the air from commercial sterilizers like PCS. This move aimed at reducing long-term risks for workers at these sterilization facilities as well as people living in nearby communities.
In March 2024, the 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. Commercial sterilizers will reduce emissions by more than 90% through the installation of proven and achievable air pollution controls.
In September 2021, the 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, the EPA issued a testing requirement in April 2022 directing the company to test its Ethylene Oxide sterilization facility's emissions control system.
Subsequently, the EPA filed an administrative complaint against PCS 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. The EPA staff was present during the performance test, reviewed the test results, and determined that PCS's control systems were meeting current control efficiency standards.
A copy of the Consent Agreement and Final Order can be provided upon request.
