Document bOvx33ZRvL45XqmJgnkEXj0Y1

Docusign Envelope ID 88B00008-0097-434F-8811-476E9C203CA2 March 31, 2025 Via Electronic Mail: k The Honorable Lee M. Zeldin Administrator Environmental Protection Agency 1200 Pennsylvania Avenue NW, Washington, DC 20460 Re: Presidential Exemption: National Emission Standards for Hazardous Air Pollutants: Ethylene Oxide Commercial Sterilization Facilities Residual Risk and Technology Review, 89 Fed. Reg. 24090 (April 5, 2024) (40 CFR Part 63, Subpart O). Dear Administrator Zeldin, I write on behalf of Medtronic Xomcd LI.0 ("Xomcd") to request that the President issue a twoyear exemption pursuant to his authority under Clean Air Act (CAA) Section 1 12(i)(4) for all emission standards and associated requirements set or revised in EPA's April 4, 2024 National Emission Standards for Hazardous Air Pollutants: Ethylene Oxide Emissions Standards for Sterilization Facilities Residual Risk and Technology Review, 89 Fed. Reg. 24090 (Apr. 5, 2024) (Sterilizer Rule). Xomcd requests that a Presidential Exemption be granted to the following facility for all emission sources regulated under the Sterilizer Rule contained therein: Xomcd Jacksonville Facility, 6743 Southpoint Drive North, Jacksonville, FL, 32216, FDEP Facility ID 0310379. Xomcd further requests that the Presidential Exemption take effect according to the compliance deadlines for the applicable standards in the Sterilizer Rule, as follows: For standards set or revised under CAA Section 1 12(f) and all corresponding requirements (including monitoring requirements), the exemption should apply as of April 6, 2026 (the compliance deadline for those standards); and For standards set or revised under CAA Section 1 12(d) and all corresponding requirements (including monitoring requirements), the exemption should apply as of April 5, 2027 (the compliance deadlines for those standards). As explained further in the attached letter submitted to EPA on March 17, 2025, on behalf of the Ethylene Oxide Sterilization Association (EOSA), the technology necessary to implement the standards set forth in the Sterilizer Rule is not available because manufacturers cannot guarantee 16[8857532.2 Sierra Club FOIA 2025-EPA-04883 ED_018388_00000188-00001 SC_EVERSPLIT0025017 Docusign Envelope ID 88B00008-0097-434F-8811-476E9C203CA2 Xomcd Request for Presidential Exemption Page 2 that existing emissions control equipment will enable sources to meet the new standards; there is not a sufficient supply of the necessary control and monitoring technology; and there are not enough experienced installation professional and technical experts to install and test that equipment within the current compliance timcframes. As also explained further in EOSA's March 17 letter, it is in the national security interests of the United States to issue the requested exemption because if the Xomed Jacksonville Facility is forced to cease operations on April 6, 2026, that will disrupt the supply of sterilized medical devices, raise the cost of those devices, and/or force medical suppliers or providers to source sterilized medical devices from abroad. If EPA requires additional information regarding the Xomcd Jacksonville Facility, including the availability of technology to comply with the Sterilizer Rule or national security risks if the Facility is forced to cease operations, we would be pleased to provide additional information as needed to fully support this request for Presidential Exemption. Please contact me if EPA has any questions or concerns regarding Xomcd's request. Xomed appreciates EPA's attention to this important matter. I can be reached by phone at (904) 296-6456 or email tim.romecki(kmedtronic.com if EPA requires any additional information not act on the requested exemption. rDocuSigned by. /610,1 1E2239.O6 Thomas Ostcraas Officer Medtronic Xomcd LLC. Enclosure: 16[8857532.2 Sierra Club FOIA 2025-EPA-04883 ED_018388_00000188-00002 SC_EVERSPLIT0025018