Document gaOd0RoRM63784RNmrqXxzjdq

Message From: Sent: To: CC: Subject: AirAction [/O=EXCHANGELABS/OU=EXCHANGE ADMINISTRATIVE GROUP (FYDIBO HF23SPDLT)/CN =RECIPIENTS/CN =FA78 B98923384078995E04A73D258D83-AlRACTION] 3/28/2025 6:41:22 PM Steve Adamietz [sadamietz@medxlpro.com] Ken Morse [kmorse@medxlpro.com] RE: Model Email to EPA Requesting Section 112(i)(4) Exemption for Sterilizer Rule Flag: Follow up Thank you for cmailing the AirAction mailbox to request a Presidential Exemption under section 112(1)(4) ofthe 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 CRI'a epa.to` inbox or in hardcopy to: USEPA, OAQPS CORE CRI Office 4930 Old Page Road Durham, NC 27703 From: Steve Adamietz <sadamietz@medxlpro.com> Sent: Friday, March 28, 2025 2:32 PM To: AirAction <AirAction@epa.gov> Cc: Ken Morse <kmorse@medxlpro.com> Subject: Model Email to EPA Requesting Section 112(i)(4) Exemption for Sterilizer Rule Caution: This email originated from outside EPA, please exercise additional caution when deciding whether to open attachments or click on provided links. Re: Sterilizer Rule (89 FR 24090): MedXL, LLC I \s rite on behalf of MedXI., 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 FPA's April 4, 2024 National Emission Statulaidsfin. Hazardous Air Pollutants: Ethylene Oxide Emissions ,S"landards Sterilization Facilities Residual Risk and Technology Review, 89 FR 24090 (April 5, 2024) (Sterilizer Rule). McdXI. requests that the Presidential Fxemption apply to the following facilities regulated by the Sterilizer Rule and all sources therein: MedXI., 3204 Hale Road, Ardmore, Oklahoma 73401 MedXl, requests that the President issue a two-year exemption as quickly as possible, hut 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 112(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 112(d) and all corresponding requirements (including monitoring requirements), the exemption should apply as of April 5, 2()27 (the compliance deadlines for those standards). Sierra Club FOIA 2025-EPA-04883 ED_018388_00005448- 00001 SC_EVERSPLIT0020750 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 w ill enable sources to meet the ne11 standards: there is not a sufficient supply of the necessary technology; and there arc not enough experienced installation professional and technical experts to install and test that equipment within the current compliance timeframes. As also explained further in HOSA'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, andior 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. MedXL appreciates EPA's attention to this important matter and urges EPA to recommend that the President issue the requested exemption as quickly as possible. Thank you! MEDXL Steve Adamietz, QA/RA Manager, Management Representative sadamietz@medxlpro.com Office; 580-226-7808 ext.4206 Cell: 405-207-4394 3204 Hale Road Ardmore, OK 73401 Sierra Club FOIA 2025-EPA-04883 ED_018388_00005448- 00002 SC_EVERSPLIT0020751