🏥Regulatory Relief for Medical Sterilization Facilities Announced
Regulatory Relief for Certain Stationary Sources To Promote American Security With Respect to Sterile Medical Equipment
Summary
Proclamation 10959 by the President grants a two-year exemption from compliance with the EtO Rule for specified commercial sterilization facilities. This exemption arises from concerns regarding the critical role of ethylene oxide in sterilizing medical equipment, emphasizing national security and the need to ensure availability of essential medical devices for patient care.
Agencies
- Executive Office of the President
Business Impact
$$$ - High
The proclamation provides regulatory relief for sterilization facilities affected by the EtO Rule, impacting compliance costs and operational timelines. It allows a two-year extension for facilities to meet emissions-control requirements, vital for ensuring a continued supply of sterile medical equipment, thus directly influencing business operations in the healthcare sector.