EPA Plans New Regulations on Ethylene Oxide Following Leaks, Health Concerns Linked to Medical Sterilization Process

Regulations come in the wake of ethylene oxide leaks reported in recent years from manufacturing facilities, which raised widespread public health concerns

Federal regulators plan to introduce new rules on safe levels of air emissions for ethylene oxide, a toxic gas used to sterilize medical equipment, which has caused health risks in certain areas of the U.S. following ethylene oxide spills from manufacturing facilities.

On August 3, the U.S. Environmental Protection Agency (EPA) issued a press release announcing the proposed ethylene oxide air pollution regulations, indicating that the agency will seek input on what those regulations should look like from stakeholders, including the public, communities and commercial sterilizers.

Ethylene oxide is a highly carcinogenic compound used to sterilize some medical devices, including those made of some polymers, metals, glass or made with multiple layers with hard-to-reach crevices. However, exposure to ethylene oxide has been linked to serious and potentially life-threatening injuries.

The last couple years have seen several major ethylene oxide spills nationwide, leading to facility closures and concerns of about potential shortages, on top of the concerns for the health and welfare of residents and workers exposed to the chemicals. These have, in turn, led to several ethylene oxide spill lawsuits.

Most of the ethylene oxide leak lawsuits have been filed against Sterigenics, which faces hundreds of lawsuits over problems stemming from leaks at its facilities in Illinois and Georgia.

In March 2019, the FDA warned that the Sterigenics plant in Willowbrook, Illinois was being shut down due to ethylene oxide leaks. Another facility in Michigan was also closed down for similar reasons. In August 2019, Georgia health officials determined similar leaks were occurring at a Sterigenics facility outside of Atlanta. That facility was shut down temporarily to address the problem.

“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 S. Regan said in the press release. “Under my watch, EPA will do everything we can to share critical information on exposure risk to the people who need and deserve this information, and to take action to protect communities from pollution.”

The EPA indicates it will engage in a “phased outreach approach” to engage the public, including detailed web materials on the risks of ethylene oxide, as well as a national public webinar scheduled for August 10. The agency says it intends to release additional, national-level information about the risk to workers in ethylene oxide sterilization facilities and those who live or spend time near them as well.

The EPA has been collecting information to promulgate Clean Air Act regulations for ethylene oxide since 2018, involving data about the risks from 100 commercial sterilizers across the U.S.

“The agency found elevated risks at or above 100 in a million in residential areas at 23 of those sterilizers,” the press release states. “Long-term exposure to high concentrations of EtO can increase the lifetime risk of getting cancer.”

The EPA intends to review Clean Air Act regulations regarding the sterilizing gas, expand environmental reporting requirements for sterilization facilities, use enforcement options where appropriate, re-evaluate how the gas is used and how to reduce ethylene oxide exposure risks to workers and those living hear facilities, and continue to research and better understand the toxic gas and its health effects.

The agency has created a registration page for the national public webinar, scheduled for August 10 from 8 p.m. to 9:30 p.m.