Document NODLekxp2MV8z6BBz9QzM6Mw

faegre drinker. J Bryan Michael Allen Se, or Manage, - redera Po cy 8 Co, sulting bryan a an@`aagradri, xer can +1 202 230 5323 d rect Faegre Drinker Biddle 8i Reath LLP 1500 K Street NW Suite 1100 Washi, gto, , DC 200O5 +1 202 230 5000 rain +1 202 842 8465 fax March 31, 2025 Environmental Protection Agency 1200 Pennsylvania Avenue, NW Washington, D.C. 20460 airaction@epa.gov Re: Subject: Presidential Exemption: Ethylene Oxide Emissions Standards for Sterilization Facilities: Trinity Sterile, Inc. Dear Sirs: On behalf of Trinity Sterile, Inc. (Trinity), we respectfully request a two-year exemption from compliance with the National Emission Standards for Hazardous Air Pollutants (NESHAP) for Commercial Sterilizers (40 CFR Part 63, Subpart O) under Section 1 12(i)(4) of the Clean Air Act. Information supporting this request is provided below. Emissions Standards or Limitations Subject to the Request: "National Emission Standards for Hazardous Air Pollutants: Ethylene Oxide Emissions Standards for Sterilization Facilities Residual Risk and Technology Review" (89 FR 24090; April 5, 2024) (Sterilizer Rule) Facility and Affected Sources: Facility Name: Trinity Sterile, Inc. Facility Address: 201 Kiley Drive, Salisbury, MD 21801 Permit Number: 045-0139 AIRS ID: 1506 Affected Sources: c Sterilization chamber vent o Two aeration room vents Length of Compliance Period Being Requested: A two-year exemption, effective as of the compliance date of April 6, 2026, and extending through April 6, 2028. Justification for the Request: 1. Technology Unavailability: The revised NESHAP requires the implementation of a permanent total enclosure (PTE) to capture all fugitive emissions. Most facilities, including Trinity's Salisbury facility, were not initially designed to implement PTE and will require substantial redesign to comply. This redesign process is technologically complex and will vary for each facility; Trinity estimates the process at its facility--including re- Sierra Club FOIA 2025-EPA-04883 ED_018388_00000131-00001 SC_EVERSPLIT0005817