Document E4wzQMn78MZ6BROv289yYo7j
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AirAction [/O=EXCHANGELABS/OU=EXCHANGE ADMINISTRATIVE GROUP (FYDIBO HF23SPDLT)/CN=RECIPIENTS/CN -FA78B98923384078995E04A73D258D83-AlRACTION] 4/2/2025 12:12:27 PM gcranston pcsinc.org [gcranston@pcsinc.org] 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:
OAQPS CRI&lepa.gov
Thank you.
From: AirAction Sent: Monday, March 31, 2025 11:25 AM To: gcranston pcsinc.org <gcranston@pcsinc.org> Subject: RE: Sterilizer Rule (89 FR 24090): Professional Contract Sterilization, Inc,
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 CIBV(6;pa.gov inbox or in hardcopy to:
USEPA. OAQPS CORE CBI Office 4930 Old Page Road Durham, NC 27703
From: gcranston pcsinc.org <gcranston@pcsinc.org> Sent: Sunday, March 30, 2025 9:44 PM To: AirAction <AirAction@epagov> Subject: Sterilizer Rule (89 FR 24090): Professional Contract Sterilization, Inc,
Caution: This email originated from outside EPA, please exercise additional caution when deciding whether to open attachments or click on provided links. I
To: di
Re: Sterilizer Rule (89 FR 24090): Professional Contract Sterilization, Inc,
I write on behalf of Professional Contract Sterilization, 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 .Standardslie Hazardous. Air Pollutants.: Ethylene Oxide Emissions ,S'iandards ,S'ierilization Facilities Residual Risk and Technology Review, 89 FR 24090 (April 5, 2024) (Sterilizer Rule).
Professional Contract Sterilization, Inc. requests that the Presidential Exemption apply to the following facilities regulated by the Sterilizer Rule and all sources therein:
40 Myles Standish Blvd, Taunton MA 02780
Sierra Club FOIA 2025-EPA-04883
ED_018388_00005645-00001
SC_EVERSPLIT0020852
Professional Contract Sterilization, 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.
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. Professional Contract Sterilization, 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.
-(iary Cranston, President Professional Contract Sterili7ation, Inc
[CONI-'II)F.N.1 lAl.ITY ANI) PRIVACY NOTICE Information transmitted by this email is proprietary to Professional ( ontract
Sterilization Inc (PCS) and is intended for usc only by the individual or entity to which it is addressed, and may contain information
that is private, pris
confidential or exempt from disclosure under applicable law If you arc not the intended recipient or it
appears that this mail has been forwarded to you without proper authority, you arc notified that any use or dissemination of this
information in any manner is strictly prohibited. In such cases, please delete this mail from your records.
Sierra Club FOIA 2025-EPA-04883
ED_018388_00005645-00002
SC_EVERSPLIT0020853