Document 2JJB3J4eQ8n15mL779z0oyxQp

Message From: Sent: To: Subject: AirAction [/O=EXCHANGELABS/OU=EXCHANGE ADMINISTRATIVE GROUP (FYDIBOHF23SPDLT)/CN=RECIPIENTS/CN=FA78B98923384078995E04A73D258D83-AIRACTION] 4/2/2025 12:09:52 PM Kevin Wagner [KWagner@sterigenics.com] CORRECTION: Updated email address for CBI related to the Presidential Exemption In the previous email, an incorrect email address was provided for the submission of electronic Confidential Business Information (CBI). The email address should be: Thank you. From: AirAction Sent: Monday, March 31, 2025 10:57 AM To: Kevin Wagner <KWagner@sterigenics.com> Subject: RE: Presidential Exemption: Sterilizer Rule (89 FR 24090): All Sterigenics U.S., LLC-Owned and Operated Facilities Thank you for emailing the AirAction mailbox to request a Presidential Exemption under section 1 12(i)(4) of the Clean Air Act and for engaging with EPA in advancing President Trump's Executive Orders and Powering the Great American Comeback. We have received your email and will be in contact soon. If you have Confidential Business Information (CBI) that you'd like to submit, please submit it in electronic version to the ;I: inbox or in hardcopy to: USEPA, OAQPS CORE CBI Office 4930 Old Page Road Durham, NC 27703 From: Kevin Wagner <IA\ iyr),, r, > Sent: Monday, March 31, 2025 10:53 AM To: AirAction 2;:; > Subject: Presidential Exemption: Sterilizer Rule (89 FR 24090): All Sterigenics U.S., LLC-Owned and Operated Facilities Caution: This email originated from outside EPA, please exercise additional caution when deciding whether to open attachments or click on provided links. I write on behalf of Sterigenics .I.I.C ("Sterigenics" or the "Company") to request that the President issue a two-year exemption pursuant to his authority under CAA Section 112(i)(4) for all emission standards and associated requirements set or revised in EPA's April 4, 2024 National Emissions Standards for Hazardous Air Pollutants: Ethylene Oxide Emissions Standards fie Sterilization Facilities Residual Risk and Technolozv Review, 89 Fcd. Reg. 24090 (Apr. 5, 2024), known as the "Sterilizer Rule." Sterigenics requests that the President issue a two-year exemption as quickly as possible and designate it as taking effect on the compliance deadlines for the standards in the Sterilizer Rule. Specifically, for standards established or revised under CAA Section I 12(t) including all related requirements such as monitoring--the exemption should apply as of April 6, 2026, the compliance deadline for those standards. The facilities and/or affected sources for which the Company is seeking a two-year exemption are: 2971 Olympic Industrial Dr SE Atlanta, GA 30339 10821 Withers Covc Park Drive Charlotte, NC 28278 1302 Avenue T Grand Prairie, TX 75050 Sierra Club FOIA 2025-EPA-04883 ED_018388_00005640- 00001 SC_EVERSPLIT0020844 4900 S Gifford Ave Los Angeles, CA 90058-2785 84 Park Road Queensbury, NY 12804 4801-63 E 50`t' Street Los Angeles, CA 90058-2709 5725 Harold Gatty Dr. Salt Lake City, UT 84116 687 S Wanamakcr Ave Ontario, CA 91761 2400 Airport Road Santa Teresa, NM 88008 Sterigenics has consistently operated its ethylene oxide ("EtO") sterilization facilities with emission controls that meet or perform better than regulatory standards. Since 2019, the Company has proactively implemented additional enhancements to further reduce already negligible EtO emissions, pioneering many new EtO sterilization facility design features. These proactive initiatives have supported ongoing efforts to align with the final Sterilizer Rule requirements. The Company is requesting this two-year exemption to facilitate an optimal installation and validation of the facility and emission control upgrades required under the Rule. The Rule's new requirements for existing critical healthcare infrastructure facilities have triggered major structural changes across emission control, process control and emission monitoring systems. Like others in the industry. Sterigenics is constrained by the increasingly limited availability of specialized consultants, control and monitoring equipment, and qualified contractors. Supply chain delays, engineering complexity, and lengthy commissioning and testing periods are making it challenging and expensive to meet the Sterilizer Rule's deadlines. Additionally, certain provisions in the Rule relating to continuous emission monitoring and secondary parameter tracking arc adding unnecessary technical complexity, cost and system integration challenges without delivering meaningful emission reductions. Extending the timeline will allow Sterigenics during the exemption period to continue making thoughtful, proactive investments and focus resources on ensuring stable, reliable compliance. Sterigenics provides FDA-required sterilization services critical to the L'.S. healthcare supply chain. Given the tight implementation timeline and the constraints associated with deploying the required technology under the Sterilizer Rule. as well as the critical role these facilities play in supportinv. L'.S. national security, the President has the authority to grant this requested relief. If you have any questions about this exemption request, please contact me at Sterigenics sincerely appreciates EPA's attention to this important matter and requests that the President issue the exemption as quickly as possible. Vice President, Global Environmental Health & Safety Sterigenics, A Sotera Health Company kwagner@sterigenics.com O: 630-928-1771 C: 708-860-9101 Sterigenics A Sotera Health company This e-mail and any files transmitted with it may contain privileged and/or confidential information. If you believe this e-mail or any of its attachments were not intended for you, you must not use, distribute, forward, print or copy this e-mail or any attached tiles. If you have received this e-mail in error, please notify the sender by reply e-mail and then immediately delete the email and all attachments. Sierra Club FOIA 2025-EPA-04883 ED_018388_00005640- 00002 SC_EVERSPLIT0020845