EPA flags high-cancer-risk EtO sterilization facilities across the country

A map showing cancer risk from an EtO plant decreasing with distance from the facility

This map of Richmond, Virginia, shows the EPA’s estimated cancer risk for the area surrounding Sterilization Services of Virginia’s EtO plant. [Image courtesy of the EPA]

The EPA today identified nearly two dozen U.S. cities where commercial sterilizers using ethylene oxide (EtO) contribute to an elevated cancer risk for residents of surrounding communities.

EtO is used on about 20 billion medical devices each year — or about half of all sterile medical devices — and in some cases it’s the only option. The FDA is seeking safer ways to use EtO and alternative means of sterilization in an effort to reduce EtO emissions due to its cancer risk, particularly blood cancers and breast cancer.

“Exposure over the course of a lifetime (24 hours a day for 70 years) to EtO at concentrations expected to be found near some commercial sterilizers can increase a person’s risk of developing cancer,” the EPA warns.

The EPA is updating the Clean Air Act’s National Emission Standards for Hazardous Air Pollutants (NESHAP) to reflect EtO’s risk and mitigating technologies, with a proposed rule anticipated to be released this year. As part of that effort, EPA scientists and analysts completed risk assessments for American communities near the nation’s approximately 100 commercial sterilizers.

The EPA risk information is current as of July 27, based on the agency’s latest modeling of EtO emissions from the facilities. Facility operators include device manufacturers such as Medtronic and Edwards Lifesciences.

“We are continuing to collect and verify information about these facilities and its emissions,” the EPA said. “If there are updates to EtO emissions or the systems in place at these facilities, there may be resulting updates to the risk information.”

The EPA said EtO facilities in 23 cities are contributing to at least 1 additional cancer case per 10,000 people exposed. The Steri-Tech facility in Salinas, Puerto Rico, appears to have the greatest increase in cancer risk of all the facilities at 60 additional cases per 10,000 people.

Workers in the facilities and neighbors who live closest are at highest risk, and the CDC says EtO’s dangers may go beyond cancer.

The cities with an elevated cancer risk due to EtO facilities are listed at the EPA’s website and below, along with links to EPA webpages with more information about the specific facility and any pollution control violations: