Document 06y9y5e9ore5o025K86V9jDVM
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AirAction [/O=EXCHANGELABS/OU=EXCHANGE ADMINISTRATIVE GROUP (FYDIBO HF23SPDLT)/CN =RECIPIENTS/CN -FA78 B98923384078995E04A73D258D83-AlRACTION] 4/2/2025 11:46:01 AM Leach, Arthur [arthur.leach@carclinalhealth.com] CORRECTION: Updated email address for CBI related to the Presidential Exemption
In the previous email, an incorrect email address was provided for the submission of electronic Confidential Business Information (CBI). The email address should be:
Thank you.
From: AirAction Sent: Friday, March 28, 2025 11:13 AM To: Leach, Arthur <arthur.leach@cardinalhealth.com> Subject: RE: Regarding Sterilizer Rule (89 FR 24090): KPR US, LLC d/b/a Kendall Patient Recovery ("KPR")
Thank you for emailing the AirAction mailbox to request a Presidential Exemption under section 112(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 CBI.:;--.L,'.oa inbox or in hardcopy to:
USEPA, OAQPS CORE CBI Office 4930 Old Page Road Durham, NC 27703
From: Leach, Arthur < i HILL,
--------------------------------------------------------------------Sent: Friday, March 28, 2025 11:04 AM
To: AirAction <A'r non
>
Subject: Regarding Sterilizer Rule (89 FR 24090): KPR US, LLC d/b/a Kendall Patient Recovery ("KPR")
Caution: This email originated from outside EPA, please exercise additional caution when I deciding whether to open attachments or click on provided links.
To: il- UfaCi.EOrepa
Re: Sterilizer Rule (89 FR 24090): KPR US, LLC d/b/a Kendall Patient Recovery ("KPR")
write on behalf of KPR 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 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).
KPR requests that the Presidential Exemption apply to the following facility regulated by the Sterilizer Rule and all sources therein:
KPR US, LLC d/b/a Kendall Patient Recovery
Sierra Club FOIA 2025-EPA-04883
ED_018388_00005597-00001
SC_EVERSPLIT0020811
1430 Marvin Griffin Road, Augusta, Georgia 30906
KPR 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 widely available to the sterilization industry 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 timeframes.
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. KPR appreciates EPA's attention to this important matter and urges EPA to recommend that the President issue the requested exemption as quickly as possible.
Thanks you for your considersation of this matter,
Arthur
CardinalHealth
Arthur Leach
Senior Vice President, Global Manufacturing
777 West Street, Mansfield, MA 02048
508.964 6941 tel / 508.212.5810 mobile
Executive Assistant: -t.
.
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Sierra Club FOIA 2025-EPA-04883
ED_018388_00005597-00002
SC_EVERSPLIT0020812
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Sierra Club FOIA 2025-EPA-04883
ED_018388_00005597-00003
SC_EVERSPLIT0020813