EPA proposes restrictions in the use of Ethylene Oxide in Commercial Sterilization Operations

Ethylene Oxide is used on half of the sterilized medical devices in the United States. However, since 2016, when EPA updated its Integrated Risk Information System classification of ethylene oxide (EtO) as a carcinogen, EPA has been considering more stringent standards for the use of EtO and emissions of EtO from a range of industrial facilities.

On April 13, 2023, EPA published proposals under two separate programs that would significantly impact the use of EtO in commercial sterilization operations: emission standards under the Clean Air Act, and restrictions on use under Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA).

Comments on both proposals are due on June 12, 2023.

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The Office of Advocacy will host a Small Business Roundtable to discuss these proposals on Tuesday, April 25, 2023, at 10 AM ET via Microsoft Teams.

• Read the Clean Air Act proposal in the Federal Register
  • Visit EPA’s website for more information
  • Visit regulations.gov for the complete docket and to comment
• Read the FIFRA proposal in the Federal Register
  • Visit EPA’s website for more information.
  • Visit regulations.gov for the complete docket and to comment.

For more information or to RSVP for the Small Business Roundtable, contact Dave Rostker at david.rostker@sba.gov.

Additional information on the upcoming roundtable is available in our Agency Roundtables section.