2060-AU37 202210 The Regulatory Plan and the Unified Agenda of Federal Regulatory and Deregulatory Actions 2060 Office of Air and Radiation OAR 2000 Environmental Protection Agency EPA National Emission Standards for Hazardous Air Pollutants: Ethylene Oxide Commercial Sterilization and Fumigation Operations

In December 1994, pursuant to section 112(d) of the CAA, 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 and 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, 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 and is conducting community outreach as part of the development of this action.

]]> Economically Significant Previously Published in The Unified Agenda Proposed Rule Stage Yes No 40 CFR 63, subpart O secs. 112 and 307(d)(7)(B) of the CAA as amended (42 U.S.C. 7412 and 7607(d)(7)(B)). This action is also subject to section 307(d) of the CAA (42 U.S.C. 7607(d)) 42 U.S.C. 7414, 7601 Yes ANPRM 12/12/2019 84 FR 67889 NPRM 03/00/2023 Final Rule 10/00/2023 EPA-HQ-OAR-2019-0178. Yes Businesses None No No 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 Yes No Jonathan Witt 2060 Office of Air and Radiation OAR 919 541-5645 witt.jon@epa.gov 109 T.W. Alexander Drive, Mail Code E143-05, Research Triangle Park NC 27709 Steve Fruh 2060 Office of Air and Radiation OAR 919 541-2837 fruh.steve@epa.gov E143-01, 109 T.W. Alexander Drive, Research Triangle Park NC 27711