EPA proposes repeal of commercial sterilizer rule
The Environmental Protection Agency (EPA) issued a proposal on March 13 to rollback the National Emission Standards for Hazardous Air Pollutants (NESHAP) for Ethylene Oxide (EtO) Commercial Sterilization Facilities.
The current standard limits emissions of EtO, a known cancer-causing gas used to sterilize medical equipment.
One of the main justifications listed within the proposal is to protect the nation’s ability to have a secure domestic supply chain of sterilized medical equipment which is essential to saving lives.
The proposal would rescind the risk-based standards, revise the standard for new aeration room vents, revise the compliance demonstration requirements and rescind a requirement related to permanent total enclosure (PTE).
The proposal also includes technical corrections and clarifications to the Commercial Sterilization Facilities NESHAP and Performance Specification 19 to address erroneous cross-references, omissions of text and typographical errors in the regulatory text that the EPA identified after publication of the current rule.
Public commenting on the proposed rollback closes May 1.
For additional information visit the EPA Proposed Reconsideration for 2024 Commercial Sterilizer Rule webpage.
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