Michael regan epa 800
Michael S. Regan, administrator, U.S. Environmental Protection Agency | epa.gov

EPA's Regan on new protections for EtO use: Our 'number one priority is protecting people's health and safety'

The U.S. Environmental Protection Agency (EPA) is proposing new health protections aimed at reducing exposure to ethylene oxide (EtO), a gas used to sterilize medical devices as well as some spices.

The proposed regulations would include stricter air emissions standards as well as more protections for workers who may be exposed to EtO, a recent EPA news release said. The proposals are likely to reduce EtO emissions by 80% annually from plants that conduct commercial sterilization of medical equipment.

“EPA’s number one priority is protecting people’s health and safety, and we are committed to taking decisive action that’s informed by the best available science,” EPA Administrator Michael S. Regan said in the release.

The EPA noted that its proposals are in line with President Joe Biden's pledge to end cancer as part of the administration’s Cancer Moonshot.

“These proposals build on EPA’s extensive outreach to communities across the nation and reflects close coordination among key federal partners,” Regan said. “Together they would significantly reduce worker and community exposure to harmful levels of ethylene oxide.”

The plan also focuses on the Biden administration’s goal to secure environmental justice and safeguard public health, particularly for at-risk communities.

“EPA will continue to use every available tool to safeguard our nation’s communities, including workers, from exposure to toxic chemicals and to deliver important public health protections,” Regan said.

The plan mandates that all facilities and any new facilities comply with the stricter pollution controls. It also requires all commercial sterilizers to use advanced source monitoring methods and report results to the EPA twice per year. Facilities would need to comply with these new requirements within 18 months.

The agency said it will also propose new mitigation standards designed to cut the potential risk for workers who use the chemical to sterilize products and for people living near sterilization plants. Its plans include banning the use of EtO when effective alternatives are available; reducing the amount of chemical used in the process while still meeting sterilization requirements; and requiring effective measures be in place to ensure worker and public safety, which may include monitoring equipment.