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

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)

Clean Air Act Section 114 Request: Revised EtO Sterilizers Section 114 Survey(316 K, 1/8/2020)

(Note: A new version of the Excel survey was posted on 01/08/2020 (the previous version was posted on 12/04/2019). In the previous version, on the “Sterilizer Chambers” tab, in Table 4, rows 110 to 119, some cells were locked and did not allow data entry. In general, if a facility has fewer than 20 sterilizers, they likely will not encounter this issue in those cells on the previous version and can continue to use that version. The formatting issue has been corrected in the current version.)

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.

Alternative Control Technology Document: Ethylene Oxide Sterilization/Fumigation Operations