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]
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.
RELATED: FDA reports sterilization challenge progress as EPA takes aim at EtO emissions
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.
RELATED: AdvaMed defends EtO facilities on EPA’s cancer risk list
“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:
- Lakewood, Colorado
- Groveland, Florida
- Taunton, Massachusetts
- Hanover, Maryland
- Jessup, Maryland
- Salisbury, Maryland
- Jackson, Missouri
- Columbus, Nebraska
- Franklin, New Jersey
- Linden, New Jersey
- Ardmore, Oklahoma
- Erie, Pennsylvania
- Zelienople, Pennsylvania
- Añasco, Puerto Rico
- Fajardo, Puerto Rico
- Salinas, Puerto Rico
- Villalba, Puerto Rico
- New Tazewell, Tennesee
- Memphis, Tennesee
- Athens, Texas
- Laredo, Texas
- Sandy, Utah
- Richmond, Virginia
Given that ETO sterilizing is vital to the safe availability of so many medical devices, perhaps the EPA might put forth a bit of effort in helping to discover an effective and cost-effective alternative method as a replacement. Or it might be able to discover cost effective methods of reducing the present emissions levels.
Issuing orders is easy, providing a bit of help that will benefit many takes a bit more effort.
And undoubtedly that aspect is a part quite foreign to the EPA.