Document b5YnDOMqEo8Ne8306VXbRVqbk
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AirAction [/O=EXCHANGELABS/OU=EXCHANGE ADMINISTRATIVE GROUP (FYDIBO HF23SPDLT)/CN =RECIPIENTS/CN =FA78 B98923384078995E04A73D258D83-AlRACTION] 4/1/2025 12:46:53 PM DConnor@Sterilization-Services.corn RE: Presidential Exemption: Sterilizer Rule (89 FR 24090): Sterilization Services of Virginia, Inc.
Thank you for emailing the AirAction mailbox to request a Presidential Exemption under section 1 12(i)(4) of the Clean
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From: DConnor@Sterilization-Services.com <DConnor@Sterilization-Services.com> Sent: Monday, March 31, 2025 3:58 PM To: AirAction <AirAction@epa.gov> Subject: Presidential Exemption: Sterilizer Rule (89 FR 24090): Sterilization Services of Virginia, Inc.
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I write on behalf of Sterilization Services of Virginia, Inc. to request that the President issue a two-year exemption pursuant to his authority under 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.fin. Hazardous Air Pollutants: Ethylene Oxide Emissions ,S'iandardslie,S'ierilization Facilities Residual Risk and Technology Review, 89 FR 24090 (April 5, 2024) (Sterilizer Rule).
Sterilization Services of Virginia, inc. requests that the President issue a two-year exemption as quickly as possible, but designate it as taking effect on the compliance deadlines for the standards in the Sterilizer Rule. Specifically:
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);
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 on behalf of the Ethylene Oxide Sterilization Association (EOSA), the technology necessary to implement the standards is not available because manufacturers cannot guarantee that existing emissions control equipment will enable sources to meet the new standards; there is not a sufficient supply of the necessary technology; and there are not enough experienced installation professional and technical experts to install and test that equipment within the current compliance timcframes.
Sierra Club FOIA 2025-EPA-04883
ED_018388_00005666-00001
SC_EVERSPLIT0020875
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 some facilities choose to cease operations rather than attempt compliance (which is likely), 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.
Please don't hesitate to let me know if any additional information is needed. Sterilization Services of Virginia, Inc. appreciates EPA's attention to this important matter and urges EPA to recommend that the President issue the requested exemption as quickly as possible.
David Connor, General Manager Sterilization Services of Virginia, Inc. (SSV)
5674 Eastport Boulevard Richmond, VA 23231-4446 Office: (804) 236-1652 ext. 115 Cell: (804) 929-5422 Email: DConnor@Sterilization-Services.com www.Sterilization-Services.com
Sierra Club FOIA 2025-EPA-04883
ED_Ol 8388_00005666-00002
SC_EVERSPLIT0020876