After a year of back and forth with the medtech industry, the US Environmental Protection Agency (EPA) has finally published a much-anticipated rule that further restricts the use of the medical device sterilization agent ethylene oxide (EtO). The agency says the rule would significantly curtail EtO emissions but gives companies ample time and flexibility to comply.
The final rule updates EPA’s policy on residual risk and technology review (RTR) for the Commercial Sterilization Facilities source category, which is regulated under the National Emission Standards for Hazardous Air Pollutants (NESHAP) under the Clean Air Act. (RELATED: Medtech groups warn EPA of ‘devastating’ impact of proposed EtO rules, Regulatory Focus 29 June 2023)…
