Air Plan Approval; New York; Ortho Clinical Diagnostics

<RULE> ENVIRONMENTAL PROTECTION AGENCY <CFR>40 CFR Part 52</CFR> <DEPDOC>[EPA-R02-OAR-2024-0494; FRL-12517-02-R2]</DEPDOC> <SUBJECT>Air Plan Approval; New York; Ortho Clinical Diagnostics</SUBJECT> <HD SOURCE="HED">AGENCY:</HD> Environmental Protection Agency (EPA). <HD SOURCE="HED">ACTION:</HD> Final rule. <SUM> <HD SOURCE="HED">SUMMARY:</HD> The Environmental Protection Agency (EPA) is approving a revision to the State of New York's State Implementation Plan (SIP) for the ozone National Ambient Air Quality Standard (NAAQS) related to a source-specific SIP (SSSIP) revision for Ortho Clinical Diagnostics, 513 Technology Boulevard, Rochester, New York (the Facility). The EPA finds that the control options in this SSSIP revision implement Reasonably Available Control Technology (RACT) with respect to volatile organic compound (VOC) emissions from the relevant Facility source, which are identified as one solvent-based film coating machine. This SSSIP revision implements VOC RACT for the relevant Facility source in accordance with the requirements for implementation of the 2008 and 2015 ozone NAAQS. This action is being taken in accordance with the requirements of the Clean Air Act (CAA). The EPA proposed to approve this rule on July 24, 2025, and received one comment which was not germane. </SUM> <EFFDATE> <HD SOURCE="HED">DATES:</HD> This final rule is effective on February 9, 2026. </EFFDATE> <HD SOURCE="HED">ADDRESSES:</HD> Submit your comments, identified by Docket ID No. EPA-R02-OAR-2024-0494, at <E T="03">https://www.regulations.gov</E> (our preferred method), or the other submission methods identified in the link below. Once submitted, comments cannot be edited or removed from the docket. EPA may publish any comment received to its public docket. Do not submit to EPA's docket at <E T="03">https://www.regulations.gov</E> any information you consider to be Confidential Business Information (CBI), Proprietary Business Information (PBI), or other information whose disclosure is restricted by statute. Multimedia submissions (audio, video, etc.) must be accompanied by a written comment. The written comment is considered the official comment and should include discussion of all points you wish to make. EPA will generally not consider comments or comment contents located outside of the primary submission ( <E T="03">i.e.,</E> on the web, cloud, or other file sharing system). Please visit <E T="03">https://www.epa.gov/dockets/commenting-epa-dockets</E> for additional submission methods; the full EPA public comment policy; information about CBI, PBI, or multimedia submissions; and general guidance on making effective comments. <FURINF> <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD> Linda Longo, Air Programs Branch, Environmental Protection Agency, 290 Broadway, New York, New York 10007-1866, at telephone number: (212) 637-3565, email address: <E T="03">longo.linda@epa.gov.</E> </FURINF> <SUPLINF> <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD> <HD SOURCE="HD1">Table of Contents</HD> <EXTRACT> <FP SOURCE="FP-2">I. What is the background for this action?</FP> <FP SOURCE="FP-2">II. What comments were received in response to the EPA's proposed action?</FP> <FP SOURCE="FP-2">III. What action is the EPA taking?</FP> <FP SOURCE="FP-2">IV. Incorporation by Reference</FP> <FP SOURCE="FP-2">V. Statutory and Executive Order Reviews</FP> </EXTRACT> <HD SOURCE="HD1">I. What is the background for this action?</HD> On July 24, 2025 (90 FR 34781), the EPA published a notice of proposed rulemaking that proposed to approve a State Implementation Plan (SIP) revision submitted by the State of New York on April 7, 2023 for purposes of establishing RACT emission limit for Ortho Clinical Diagnostics. The proposed SIP revision establishes the lowest VOC emission limit with the application of control technology that is reasonably available given technological and economic feasibility considerations for the Facility's coating machine, 72 Machine. 72 Machine is part of a surface coating line to produce testing slides. The coating process falls under New York Code of Rules and Regulations subpart 228-1, “Surface Coating Processes.” The State's April 7, 2023 SIP submittal consists of a RACT demonstration that includes technical analysis and cost assessment for seven applicable control technologies. The Facility's RACT demonstration shows that controlling the overspray is the only VOC control technology that is technologically and economically feasible for 72 Machine, and that controlling the overspray ensures the VOC emissions will not exceed 21,600 pounds per year on a 12-month rolling total basis. <SU>1</SU> <FTREF/> Under 6 NYCRR subpart 228-1.5(e), NYSDEC may allow surface coating processes to operate with a lesser degree of control, as established in the applicable presumptive RACT requirements, provided that a process specific RACT demonstration satisfies NYSDEC's regulations, and it addresses technical and economic feasibility of utilizing compliant coatings. <FTNT> <SU>1</SU>  The respective VOC emission limit is contained in the Facility's air permit, State Facility Permit, 8-2628-00503/02001, under Condition 13, issued by the State on October 31, 2022, and expires on October 30, 2032. The Condition 13 is being incorporated into the SIP and includes monitoring, reporting, and recordkeeping requirements. </FTNT> The July 24, 2025 proposed action outlines the EPA's review of the Facility's RACT determination showing three control technologies for 72 Machine that are technically feasible but are not cost effective, which are: (1) Thermal oxidation; (2) catalytic oxidation; and (3) ducting the VOC exhaust from 72 Machine to the Facility's other coating machine. <SU>2</SU> <FTREF/> The EPA reviewed vendor quotes and cost analyses submitted by the Facility and compared similar sources in the United States. The EPA confirms that no cost-effective VOC control technologies have become available that could be implemented on 72 Machine. <FTNT> <SU>2</SU>  The supporting documentation in the July 24, 2025 proposed action also noted four additional control measures that were analyzed and found to be not technically feasible to install and operate, therefore, no cost assessment was required. Those additional measures were: (1) liquid absorption; (2) carbon adsorption; (3) condenser; and (4) biofiltration. </FTNT> The specific details of New York's SIP submittals and the rationale for the EPA's approval action are explained in the EPA's proposed rulemaking and are not restated in this final action. For this detailed information, the reader is referred to the EPA's July 24, 2025, proposed rulemaking (90 FR 34781). <HD SOURCE="HD1">II. What comments were received in response to the EPA's proposed action?</HD> In response to the EPA's July 24, 2025 proposed rulemaking on New York SIP revision submittal, the EPA received one comment during the 30-day public comment period. After reviewing the comment, the EPA has determined that the comment is outside the scope of our proposed action or fails to identify any material issue necessitating a response. The comment does not raise issues germane to the EPA's proposed action. Therefore, we are finalizing our action as proposed. The specific comment may be viewed under Docket ID Number EPA-R02-OAR-2024-0494 on the <E T="03">https://www.regulations.gov</E> website. <HD SOURCE="HD1">III. What action is the EPA taking?</HD> The EPA is approving the revision to the NYSDEC Ortho Clinical Diagnostics SSSIP revision submitted on April 7, 2023, for purposes of satisfying RACT for the NYSDEC-approved VOC emission limit for 72 Machine. <HD SOURCE="HD1">IV. Incorporation by Reference</HD> In this document, the EPA is finalizing the regulatory text that includes incorporation by reference. In accordance with requirements of 1 CFR 51.5, the EPA is finalizing incorporate by reference revisions to Ortho Clinical Diagnostics State Facility Permit, 8-2628-00503/02001, condition 13, described in the amendments to 40 CFR part 52 as discussed in section I. of this preamble. These documents are available in the docket of this rulemaking through <E T="03">https://www.regulations.gov.</E> Therefore, these materials have been approved by the EPA for inclusion in the State Implementation Plan, have been incorporated by reference by the EPA into that plan, are fully federally enforceable under sections 110 and 113 of the CAA as of the effective date of the final rulemaking of the EPA's approval, and will be incorporated by reference in the next update to the SIP compilation. <SU>3</SU> <FTREF/> <FTNT> <SU>3</SU>  62 FR 27968 (May 22, 1997). </FTNT> <HD SOURCE="HD1">V. Statutory and Executive Order Reviews</HD> Under the CAA, the Administrator is required to approve a SIP submission that complies with the provisions of the CAA and applicable Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in reviewing SIP submissions, EPA's role is to approve state choices, provided that they meet the criteria of the CAA. Accordingly, this action merely approves state law as meeting Federal requirements and does not impose additional requirements beyond those imposed by state law. For that reason, this action: • Is not a significant regulatory action subject to review by the Office of Management and Budget under Executive Order 12866 (58 FR 51735, October 4, 1993); • Is not subject to Executive Order 14192 (90 FR 9065, February 6, 2025) because SIP actions are exempt from review under Executive Order 12866; • Does not impose an information collection burden under the provisions of the Paperwork Reduction Act (44 U.S.C. 3501 <E T="03">et seq.</E> ); • Is certified as not having a significant economic impact on a substantial number of small entities under the Regulatory F ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━ Preview showing 10k of 14k characters. 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