Document 1gRKQD6ON2ZyMp9ea1aaop87K

Message From: Sent: To: CC: Subject: Attachments: AirAction [/O=EXCHANGELABS/OU=EXCHANGE ADMINISTRATIVE GROUP (FYDIBOHF23SPDLT)/CN=RECIPIENTS/CN=FA78B98923384078995E04A73D258D83-AIRACTION] 3/26/2025 8:15:12 PM Shrager, Brian [Shrager.Brian@epa.gov]; McGinn, Kevin [mcginn.kevin@epa.gov]; Branning, Amy [Branning.Amy@epa.gov]; South, Peter [South.Peter@epa.gov]; McLamb, Marguerite [McLamb.Marguerite@epa.gov]; Anderson, Lea [anderson.lea@epa.gov] Noonan, Jenny [Noonan.Jenny@epa.gov] FW: Sterilizer Rule (89 FR 24090): [International Sterilization Laboratory] FINAL EOSA Letter re NESHAP.pdf Hi all We received a Presidential Exemption request. For your awareness, please see the email below and attached letter. From: Steve Walter <swalter@asocorp.com> Sent: Wednesday, March 26, 2025 11:53 AM To: AirAction <AirAction@epa.gov> Cc: Douglas Parzuchowski <dparzuchowski@isl-fl.com> Subject: Sterilizer Rule (89 FR 24090): [International Sterilization Laboratory] Caution: This email originated from outside EPA, please exercise additional caution when deciding whether to open attachments or click on provided links. TO: ,tuJc',h11 _ . Re: Sterilizer Rule (89 FR 24090): International Sterilization Laboratory I write on behalf of [international Sterilization Laboratory] 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 Emission Standardyl0r Hazardous' Air Pollutants.: Ethylene Oxide Emissions ,S.tandardsl0r ,S.terililation Facilities Residual Risk and Technology Review, 89 FR 24090 (April 5, 2024) (Sterilizer Rule). International Sterilization Laboratory requests that the Presidential Exemption apply to the following facilities regulated by the Sterilizer Rule and all sources therein: e International Sterilization Laboratory, 217 Sampey Road, Grovelanci, Florida, 34736 International Sterilization Laboratory 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 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, 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 Sierra Club FOIA 2025-EPA-04883 ED_018388_00005684-00001 SC_EVERSPLIT0020883 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 arc 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 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. [International Sterilization Laboratory] appreciates EPA's attention to this important matter and urges EPA to recommend that the President issue the requested exemption as quickly as possible. Sincerely, Steve Walter Vice President ISL International Sterilization Laboratory Phone: 941-378-6649 Cell: 813-843-2124 Email: swalter @ISL-FL com NOTICE This e-maxi may contain confidential information It rs intended only for the use of the person(s) named above If you have received this e-mail in error; you are hereby notified that any review, dissemination, distribution or duplication of this communication is strictly prohibited If you are not the intended recipient, please notify us immediately by reply e-mail, destroy all copies of the message, and delete the message from your system Unless stated to the contrary, any opinions or comments contained in the e-mail are personal to the writer and do not represent the official view of the company Thank you for your cooperation Although this email and any attachments are believed to be free of any VIRUS or other defect that might affect any computer system into which it is received and opened, it is the responsibility of the recipient to ensure that it is virus free and ASO Corporation, ASO LLC, its officers, directors, affiliates, agents, and employees accept no responsibility for any Joss or damage Sierra Club FOIA 2025-EPA-04883 ED_Ol 8388_00005684-00002 SC_EVERSPLIT0020884