Updated: Mar 2
The U.S. Environmental Protection Agency (EPA) recently completed a risk assessment for commercial sterilizing facilities (they sterilize medical equipment and devices and more) that use the hazardous air pollutant ethylene oxide.
The determination was startling: It found emissions of ethylene oxide from these facilities increase the lifetime cancer risk for the people who live near them.
For the uninitiated: Ethylene oxide is a flammable gas with a somewhat sweet odor and in addition to increased cancer risk, exposure may cause myriad ailments, from headache, nausea, vomiting, and diarrhea to breathing difficulty, drowsiness, weakness, exhaustion, eye and skin burns, frostbite, and even reproductive effects.
Now, like with so many other air quality issues, we now need to back up and explain a little bit of the process: The assessment was conducted because EPA is charged under the Clean Air Act with the duty of periodically re-assessing the health risks posed by emissions of hazardous air pollutants.
As a result of this risk assessment, EPA will propose more stringent regulations governing ethylene oxide emissions from commercial sterilizing facilities later this year.
Two commercial sterilizing facilities in western Pennsylvania are among those EPA found to contribute to an increased lifetime cancer risk to their neighbors: American Contract Systems, Inc., in Zelienople, Butler County, and Cosmed Group LLC/Erie in the City of Erie.
EPA purportedly is working with the Pennsylvania Department of Environmental Protection (DEP) to review the emission controls already in place at these facilities and to determine whether new or improved emission controls are needed at the facilities.
A GASP review of the operating permit for Cosmed Group shows it is already required to operate control equipment that removes ethylene oxide with at least 99 percent efficiency.
“American Contract Systems, however, is apparently not subject to any air pollution control permits at this time – DEP’s eFACTS website shows the company just applied for its first plan approval on July 19, 2022, and that DEP is currently reviewing the company’s application for that plan approval,” GASP senior staff attorney John Baillie explained.
“Why American Contract Systems does not appear in DEP’s database of air pollution control permits is a good question. It appears that the facility has been in operation since at least 2018, when the FDA found the facility was not complying with regulations governing the production of medical devices.”
EPA will hold a national public webinar to provide more information to communities at risk from ethylene oxide emissions at 8 p.m. Aug. 10, 2022.
GASP continues to follow this issue and will keep you posted as the regulatory process unfolds.