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EPA/OAR RIN: 2060-AU37 Publication ID: Spring 2024 
Title: National Emission Standards for Hazardous Air Pollutants: Ethylene Oxide Emissions Standards for Sterilization Facilities Residual Risk and Technology Review 
Abstract:

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 (EtO) 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 conducted the second RTR for the NESHAP and  updated 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 has conducted outreach meetings within the communities affected by the highest-risk facilities as part of the development of this action. These meetings involved informing community members of the risk from EtO emissions and explaining how they can be involved in the rule writing process. EPA also held a national webinar on this proposal. Accommodations were made for Spanish-language speaking communities, which are disproportionately affected by these EtO emissions. This final rule also reflects feedback EPA received from representatives of local and state governments. For more information, please visit https://www.epa.gov/stationary-sources-air-pollution/ethylene-oxide-emissions-standards-sterilization-facilities.

 
Agency: Environmental Protection Agency(EPA)  Priority: Section 3(f)(1) Significant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Completed Actions 
Major: No  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:
Action Source Description Date
Final  Judicial  Final rule due 3/1/2024 due to consent decree per California Communities Against Toxics et al. v. Regan, No. 1:22-cv-03724  03/01/2024 
Timetable:
Action Date FR Cite
ANPRM  12/12/2019  84 FR 67889   
NPRM  04/13/2023  88 FR 22790   
Final Rule  04/05/2024  89 FR 24090   
Final Rule Effective  04/05/2024 
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
Email: witt.jon@epa.gov

Kusondra King
Environmental Protection Agency
Office of Air and Radiation
Research Triangle Park, NC 27711
Phone:919 541-4373
Email: king.kusondra@epa.gov