Chairman Guthrie Applauds EPA Decision to Address Regulations that Targeted Life-Saving Medical Devices

WASHINGTON, D.C. - Today, Congressman Brett Guthrie (KY-02), Chairman of the House Committee on Energy and Commerce, issued the following statement following Environmental Protection Agency (EPA) Administrator Zeldin's announcement that the agency proposed amending a Biden-Harris Administration regulation that weaponized air emissions standards to halt the production and use of ethylene oxide (EtO) to sterilize medical equipment.

"Today's EPA announcement is a victory for commonsense policies that safeguard patients and put an end to the overreach of the Biden-Harris Administration," said Chairman Guthrie. "The burdensome ethylene oxide rule threatened to shutter sterilization facilities and disrupt American medical supply chains that hospitals and providers rely on every day to safely treat patients. By proposing an amendment to this misguided regulation, EPA Administrator Zeldin is working under the authority that Congress provided under the Clean Air Act to help ensure the medical community maintains access to a safe and reliable domestic supply of sterilized medical devices used in millions of procedures each year, while continuing to protect human health and the environment."

BACKGROUND:

• Ethylene oxide (EtO) is used to sterilize approximately half of all medical devices sold in the United States, including surgical instruments, syringes, and implants. For many heat- and moisture-sensitive devices, there is currently no viable alternative sterilization method.
• The emission standards put in place by the Biden-Harris Administration threatens the ability for facilities to fully and safely sterilize essential medical equipment.
• In 2023, the Committee on Energy and Commerce, Subcommittee on Environment, Manufacturing, & Critical Materials held a hearing on the Biden-Harris Administration's proposed rulemaking, where witnesses testified to how the proposal would significantly disrupt patient access to emergency care and threaten patient safety from hospital-born infections.