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EPA/OAR RIN: 2060-AU37 Publication ID: Fall 2021 
Title: National Emission Standards for Hazardous Air Pollutants: Ethylene Oxide Commercial Sterilization and Fumigation Operations 

The National Emission Standards for Hazardous Air Pollutants (NESHAP) for Ethylene Oxide Commercial Sterilization and Fumigation Operations were finalized in December 1994 (59 FR 62585). The standards require existing and new major sources to control emissions to the level achievable by the maximum achievable control technology (MACT) and require existing and new area sources to control emissions using generally available control technology (GACT). 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 and also assess potential updates to the rule. To aid in this effort, EPA issued an advance notice of proposed rulemaking (ANPRM) that solicited comment from stakeholders and undertook a Small Business Advocacy Review (SBAR) panel, which is needed when there is the potential for significant economic impacts to small businesses from any regulatory actions being considered. EPA is also planning to undertake community outreach as part of the development of this action.

Agency: Environmental Protection Agency(EPA)  Priority: Other Significant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Proposed Rule Stage 
Major: No  Unfunded Mandates: No 
CFR Citation: 40 CFR 63   
Legal Authority: 42 U.S.C. 7412 Clean Air Act    42 U.S.C. 7607(d)(7)(B)   
Legal Deadline:  None

Statement of Need: The National Air Toxics Assessment (NATA) released in August 2018 identified ethylene oxide (EtO) emissions as a potential concern in several areas across the country. The latest NATA estimates that EtO significantly contributes to potential elevated cancer risks in some census tracts. These elevated risks are largely driven by an EPA risk value that was updated in December 2016. Further investigation on NATA inputs and results led to the EPA identifying commercial sterilization using EtO as a source category contributing to some of these risks. Over the past two years, the EPA has been gathering additional information to help evaluate opportunities to reduce EtO emissions in this source category through potential NESHAP revisions. In this rule, EPA will address EtO emissions from commercial sterilizers.

Summary of the Legal Basis: CAA section 112, 42 U.S.C. 7412, provides the legal framework and basis for regulatory actions addressing emissions of hazardous air pollutants from stationary sources. CAA section 112(d)(6) requires EPA to review, and revise as necessary, emission standards promulgated under CAA section 112(d) at least every 8 years, considering developments in practices, processes, and control technologies.

Alternatives: EPA is evaluating various options for reducing EtO emissions from commercial sterilizers under the NESHAP, such as pollution control equipment, reducing fugitive emissions, or monitoring.

Anticipated Costs and Benefits: Based on conversations with regulated entities who have been working to reduce emissions, the potential costs of controlling some emissions sources could be substantial.

Risks: As part of this rulemaking, EPA has been updating information regarding EtO emissions and the specific emission points within the source category. Preliminary analyses suggest that fugitive emissions from commercial sterilizers may substantially contribute to health risks associated with exposure to EtO.

Action Date FR Cite
ANPRM  12/12/2019  84 FR 67889   
NPRM  06/00/2022 
Final Rule  10/00/2022 
Additional Information: .
Regulatory Flexibility Analysis Required: Yes  Government Levels Affected: None 
Small Entities Affected: Businesses  Federalism: No 
Included in the Regulatory Plan: Yes 
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