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EPA/OAR RIN: 2060-AU37 Publication ID: Spring 2023 
Title: National Emission Standards for Hazardous Air Pollutants: Ethylene Oxide Commercial Sterilization and Fumigation Operations 

In December 1994, pursuant to section 112(d) of the Clean Air Act, EPA promulgated the National Emission Standards for Hazardous Air Pollutants (NESHAP) for Ethylene Oxide Commercial Sterilization and Fumigation Operations (59 FR 62585). The NESHAP established standards for both major and area sources. EPA completed a residual risk and technology review for the NESHAP in 2006 and, at that time, concluded that no revisions to the standards were necessary. In this action, EPA will conduct the second technology review for the NESHAP, as required by law, and consider potential updates to the rule. To aid in this effort, EPA issued an advance notice of proposed rulemaking that solicited comment from stakeholders, undertook a Small Business Advocacy Review panel, which is needed when there is the potential for significant economic impacts to small businesses from any regulatory actions being considered, and is conducting community outreach as part of the development of this action. For more information, please visit

Agency: Environmental Protection Agency(EPA)  Priority: Economically Significant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Proposed Rule Stage 
Major: Yes  Unfunded Mandates: No 
CFR Citation: 40 CFR 63, subpart O     (To search for a specific CFR, visit the Code of Federal Regulations.)
Legal Authority: 42 U.S.C. 7607(d)    42 U.S.C. 7414, 7601   
Legal Deadline:  None
Action Date FR Cite
ANPRM  12/12/2019  84 FR 67889   
NPRM  04/13/2023  88 FR 22790   
NPRM Comment Period Extended  06/01/2023  88 FR 35808   
NPRM Comment Period End  06/27/2023 
Final Rule  03/00/2024 
Additional Information: EPA-HQ-OAR-2019-0178.
Regulatory Flexibility Analysis Required: Yes  Government Levels Affected: None 
Small Entities Affected: Businesses  Federalism: No 
Included in the Regulatory Plan: No 
Sectors Affected: 311423 Dried and Dehydrated Food Manufacturing; 311942 Spice and Extract Manufacturing; 325412 Pharmaceutical Preparation Manufacturing; 33911 Medical Equipment and Supplies Manufacturing; 561910 Packaging and Labeling Services 
RIN Data Printed in the FR: Yes 
Agency Contact:
Jon Witt
Environmental Protection Agency
Office of Air and Radiation
109 T.W. Alexander Drive, Mail Code E143-05,
Research Triangle Park, NC 27709
Phone:919 541-5645

Steve Fruh
Environmental Protection Agency
Office of Air and Radiation
E143-01, 109 T.W. Alexander Drive,
Research Triangle Park, NC 27711
Phone:919 541-2837