The U.S. Environmental Protection Agency’s inspector general this week recommended opening a channel of communication between government officials and people who live near 25 plants that use ethylene oxide (EtO), including eight used for sterilizing medical devices.
But EPA administrator Andrew Wheeler objected, publicly indicating that his office was blindsided by the request.
The forum would provide residents in all communities near 25 EPA-designated, EtO-using or -producing facilities the ability to discuss health concerns related to EtO exposure with the agency or state officials. The EPA identified EtO as a “new and significant driver of cancer risk” in its 2014 National Air Toxics Assessment (NATA). It released that information in 2018, acknowledging it was based on emission inventories reported for 2014 and prompting backlash from the medtech industry.
The list of 25 facilities includes the following medtech sterilization operations:
- An Edwards Lifesciences plant in Anasco, Puerto Rico.
- A B. Braun Medical plant in Hanover, Pa.
- A Becton Dickinson plant in Covington, Ga.
- Sterigenics plants in Willowbrook, Ill., Smyrna, Ga., and Santa Teresa, N.M.
- A Medline Industries plant in Waukegan, Ill.
- Midwest Sterilization Corp. plants in Laredo, Tex., and Jackson, Mo.
- A Terumo plant in Lakewood, Colo.
- A Viant Medical plant in Grand Rapids, Mich.
The Sterigenics Willowbrook plant and the Viant plant in Michigan are now closed.
The inspector general’s office said it developed its list using data from EPA-generated lists of facilities that contributed to elevated estimated cancer risks at the census-tract level in the 2014 NATA, census block-level measurements and information from EPA-designated regions. Census tracts are small, relatively permanent statistical subdivisions of a county with boundaries that normally follow visible features, such as roads and streams. Census tracts ideally contain about 4,000 people and 1,600 housing units.
The EPA considers 22 of the 25 facilities as contributing to an elevated estimated cancer risk equal to or greater than 100 in 1 million at the census-tract level. All the medtech sterilization facilities on the list are considered commercial operations and fall into this category. The three facilities whose emissions the EPA considers pose a greater cancer risk are industrial EtO sites.
The EPA had previously recommended completing more refined investigations of risk before conducting significant public outreach, the inspector general’s management alert said.
Wheeler countered that previous discussions with the inspector general’s office put them on the same page regarding public input. The EPA has been in regular contact with communities and stakeholders potentially affected by ethylene oxide emissions, according to a news release.
“Most surprising is that in our final meeting with the IG’s office on this matter they provided no indication that there would be any unresolved issues,” Wheeler said in the statement. “As a result, we are formally requesting the EPA IG rescind the report so it can be appropriately updated.”