Document KRQXBRYMo1oM2Yj5DKBoq4ODr

Message From: Sent: To: Subject: AirAction [/O=EXCHANGELABS/OU=EXCHANGE ADMINISTRATIVE GROUP (FYDIBOHF23SPDLT)/CN=RECIPIENTS/CN=FA78898923384078995E04A73D258D83-AIRACTION] 3/31/2025 3:31:09 PM David Howe [dhowe@cosmedgroup.com] RE: Presidential exemption: Sterilizer Rule (89 FR 24090): All facilities owned by Cosmed Group, Inc., Jamestown, RI 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 131 inbox or in hardcopy to: USEPA. OAQPS CORE CBI Office 4930 Old Page Road Durham, NC 27703 From: David Howe <dhowe@cosmedgroup.com> Sent: Monday, March 31, 2025 11:23 AM To: AirAction <AirAction@epa.gov> Cc: Deborah Lent <Deborah.Lent@cosmedgroup.com>; Karen Burns <kburns@cosmedgroup.com>; Christine Render <crender@cosmedgroup.com> Subject: Presidential exemption: Sterilizer Rule (89 FR 24090): All facilities owned by Cosmed Group, Inc., Jamestown, RI Caution: This email originated from outside EPA, please exercise additional caution when deciding whether to open attachments or click on provided links. To: ,T., Re: Presidential exemption: Sterilizer Rule (89 FR 24090): All facilities owned by Cosmed Group, Inc., Jamestown, RI Cosmcd Group, Inc. (Cosmcd) hereby requests 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 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). Cosmcd requests that the requested Presidential exemption apply to the following facilities regulated by the Sterilizer Rule and all sources therein: Cosmed Group. Inc., dibia Cosmed of Pennsylvania , 2205 East 33rd Street, Erie, PA. FRS II) 1 10000332015 Cosmcd Group, Inc., d/b/a Cosmcd of New Jersey, 19 Park Drive, Franklin, NJ, FRS 1D I 10070557911 Cosmed Group Inc., 2500 Brunswick Avenue, Linden, NJ, FRS II) 110000318567 Cosmcd requests that the President issue a two-year exemption as quickly as possible but designate the exemption as taking effect beginning on the compliance deadlines for the standards in the Sterilizer Rule. Specifically, (1) for standards set or revised under CAA Section 112(1) and all corresponding requirements (including monitoring requirements), the exemption should apply as of April 6, 2026 (the compliance deadline for those standards), and (2) 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, 2027 (the compliance deadlines for those standards). Sierra Club FOIA 2025-EPA-04883 ED_018388_00005675-00001 SC_EVERSPLIT0020877 Cosmcd conducts ethylene oxide sterilization operations at the facilities identified above and is a member of the Ethylene Oxide Sterilization Association (EOSA). As explained limber in the attached letter submitted to EPA on March 17, 2025 on behalf of the EOSA, the technology necessary to implement the standards set forth in the Sterilizer Rule 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 professionals and technical experts to install and test that equipment within the compliance timeframes specified in the Sterilizer Rule. As also explained further in EOSA's March 17, 2025 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 seems 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 do not hesitate to contact us if additional information is needed. Cosmcd appreciates EPA's attention to this important matter and urges EPA to recommend that the President issue the requested exemption as quickly as possible. Cosmcd Group, Inc. Debtor in Possession Disclaimer ' P r safer a more useful C' F - Mimecast Ltd. i Sierra Club FOIA 2025-EPA-04883 ED_018388_00005675-00002 SC_EVERSPLIT0020878