Ethylene Oxide Emissions Standards for Sterilization Facilities: National Emission Standards for Hazardous Air Pollutants (NESHAP)
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Rule Summary
This action promulgates National Emission Standards for Hazardous Air Pollutants (NESHAP) for ethylene oxide commercial sterilization and fumigation operations. These standards implement section 112 of the Clean Air Act and are based on the Administrator's determination that commercial sterilization and fumigation operations emit ethylene oxide, a pollutant identified in the Act list of 189 hazardous air pollutants (HAP). The intent of the standards is to protect public health by requiring existing and new major sources to control emissions to the level achievable by the maximum achievable control technology (MACT) and by requiring existing and new area sources to control emissions using generally available control technology (GACT).
Rule History
05/10/2021 - Proposed Information Collection Request, 2nd Notice
06/05/2020 - Proposed Information Collection Request
12/12/2019 - Advanced Notice of Proposed Rulemaking
04/07/2006 - Final Decision
03/25/2005 - Proposed Rulemaking
12/19/2005 - Final Rule (Title V Operating Permit Deferrals for Area Sources)
10/24/2005 - Proposed Decision; request for comment
11/02/2001 - Final Rule; amendments
12/14/1999 - Final Rule; amendments (Title V Operating Permit Deferrals for Area Sources)
08/18/1999 - Proposed Amendments (Title V Operating Permit Deferrals for Area Sources)
10/23/1997 - Notice
06/03/1996 - Final Rule
12/13/1995 - Proposed Rule
12/06/1994 - Final Rule
03/07/1994 - Proposed Rule & Notice of Public Hearing
Additional Resources
Clean Air Act Section 114 Request: EtO Sterilizers Section 114 Instructions and Survey (zip)
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Download the zip file above and unzip to your computer to extract the Excel workbooks and the Instructions document.
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Note: The Excel workbooks and Instructions document provided on this web page should be used if your company did not receive the December 2019 questionnaire issued by the EPA. The companies that responded to the December 2019 questionnaire should refer to the materials enclosed in the package received directly from the EPA.
Press Release: Advance Notice of Proposed Rulemaking on the National Emission Standards for Hazardous Air Pollutants: Ethylene Oxide Commercial Sterilization and Fumigation Operations (12/05/2019)
Fact Sheet: Advance Notice of Proposed Rulemaking on the National Emission Standards for Hazardous Air Pollutants: Ethylene Oxide Commercial Sterilization and Fumigation Operations (12/05/2019)
Small Entity Representative (SER) Nomination Website
Ethylene Oxide Commercial Sterilization and Fumigation Operations NESHAP: Implementation Document
Fact Sheets: Final Air Toxics Rules for Ethylene Oxide Emissions from Commercial Sterilization and Fumigation Operations (11/15/1994 and 11/29/1999)
Fact Sheets: Proposed Air Toxics Standards for Hospital Sterilizers (10/19/2006 and 12/20/2007)
View the supporting documents in the docket folder to find additional related documents to this rule.
Related Rules
Alternative Control Technology Document: Ethylene Oxide Sterilization/Fumigation Operations