The Environmental Protection Agency is warning residents who live near medical sterilizing plants in 13 states and Puerto Rico about potential health risks from emissions of ethylene oxide, a chemical used widely in their operations.
One of those facilities is Professional Contract Sterilization, Inc. in Taunton. The company uses ethylene oxide — or EtO — to sterilize everything from ace bandages to hip implants to artificial organs. In the U.S., approximately half of all sterile medical devices are treated with EtO.
PCS forcefully pushed back against the EPA’s health warnings on Wednesday. The company's president, Gary Cranston, said requiring sterilizers to reduce emissions too much could drive U.S. companies out of business. Cranston said that would force the country to rely on China, where there is less oversight and fewer quality control measures in place.
“I've been involved about 45 years doing sterilization of medical devices and medical products, and the new limits that everybody's looking at are going to be difficult to achieve," said Cranston, who pointed out that EtO is naturally occurring and questioned the EPA's assertions about its potential health risks.
While short-term or infrequent exposure to ethylene oxide does not appear to pose a health risk, EPA said long-term or lifetime exposure to the chemical could lead to a variety of health impacts, including lymphoma and breast cancer.
The EPA’s warnings come after a recent survey of emissions data from nearly 100 commercial sterilizers nationwide. The agency identified 23 plants that it said pose a risk to the surrounding communities.
“Today, EPA is taking action to ensure communities are informed and engaged in our efforts to address ethylene oxide, a potent air toxic posing serious health risks with long-term exposure,” EPA Administrator Michael Regan said in a statement Wednesday. The agency said it is working with commercial sterilizers to take appropriate steps to reduce emissions.
EPA will conduct public outreach campaigns in each of the communities where elevated risks have been found, including a webinar scheduled for August 10. More than half the sites on EPA’s watch list are in predominantly minority or low-income communities. In addition to Taunton, plants are located in Laredo, Texas; Ardmore, Oklahoma; and Lakewood, Colorado, among other places.
Cranston said EPA officials came to his facility Wednesday and informed him that residents in a 5-mile radius of the plant will be notified of potential exposure.
The Ethylene Oxide Sterilization Association, an industry group, said in a statement that EtO has been used for decades. For many medical devices, there are no practical alternatives currently available, the group said, adding that use of less effective cleaning methods “could introduce the real risks of increased morbidity and mortality" at hospitals throughout the country.
Later this year the EPA plans to propose an update to the rules regulating emissions from commercial sterilizers and facilities that manufacture EtO.