Two Illinois U.S. senators and two Illinois congressmen have asked the Environmental Protection Agency (EPA) and the Food and Drug Administration (FDA) to take drastic action on the widely used sterilizing chemical ethylene oxide (EtO), calling on EPA to tighten standards and for the FDA to convene a panel to develop alternatives.
The senators, Tammy Duckworth and Dick Durbin, wrote a letter to the Occupational Safety and Health Administration (OSHA) to develop alternatives to EtO in workplaces, including hospitals, ambulatory surgery centers, and any other health care facilities using EtO to sterilize medical supplies and equipment.
Why is this happening, and why now?
Their actions arise in part from a dogfight in Illinois between the state’s Democratic attorney general on one side, and on the other, the state’s Republican governor and a leading medical sterilization company, Sterigenics International.
The ongoing Illinois dispute is over allegedly high risks of several kinds of cancer in the communities around the Sterigenics plant in Willowbrook, Illinois, due to its discharges of EtO from sterilization processes. Sterigenics has an old EPA permit to discharge about 32,000 pounds of EtO into the air, and in recent years has discharged about 5,000 pounds into the air per year, according to a federal government inter-agency letter, “Evaluation of Potential Health Impacts from Ethylene Oxide Emissions.”
Also, regulations, issued in 2008 and earlier, pre-date two significant recent actions:
- a 2014 EPA National Air Toxics Assessment (NATA) estimated “that ethylene oxide significantly contributes to potential elevated cancer risks in some census tracts across the U.S.” One of these is the residential neighborhood around the Sterigenics plant. EPA began that monitoring because of the amounts Sterigenics has been allowed to discharge for decades.
- EPA officially declared in 2016 that the risk of cancer from EtO is higher than the risk level previously used to set federal regulations. Neither EPA nor OSHA rules have yet been tightened in the wake of that declaration.
EtO exposures in hospitals are possible
OSHA says that when there is exposure to EtO in a hospital or ambulatory surgery setting, it “usually results from improper aeration of the ethylene oxide chamber after the sterilizing process or during off-gassing of sterilized items or poor gas-line connections. It can also occur in outpatient surgery clinics, cardiac catheterization laboratories, operating rooms, dental labs, autopsy labs and other areas.”
In a 2015 survey for the National Institute for Occupational Safety and Health, about 38% of respondents in hospitals were using EtO in 2011 to sterilize some equipment which cannot be sterilized with steam or radiation. The number may have declined since then because an alternative, hydrogen peroxide plasma, is safer and many hours faster. See “Ethylene Oxide and Hydrogen Peroxide Gas Plasma Sterilization: Precautionary Practices in U.S. Hospitals.”
