Rule2026-00281
Air Plan Approval; New York; Ortho Clinical Diagnostics
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
January 9, 2026
Effective
February 9, 2026
Issuing agencies
Environmental Protection Agency
Abstract
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.
Full Text
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<title>Federal Register, Volume 91 Issue 6 (Friday, January 9, 2026)</title>
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[Federal Register Volume 91, Number 6 (Friday, January 9, 2026)]
[Rules and Regulations]
[Pages 907-909]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-00281]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 52
[EPA-R02-OAR-2024-0494; FRL-12517-02-R2]
Air Plan Approval; New York; Ortho Clinical Diagnostics
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: 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.
DATES: This final rule is effective on February 9, 2026.
ADDRESSES: Submit your comments, identified by Docket ID No. EPA-R02-
OAR-2024-0494, at <a href="https://www.regulations.gov">https://www.regulations.gov</a> (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 <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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 (i.e., on the web,
cloud, or other file sharing system). Please visit <a href="https://www.epa.gov/dockets/commenting-epa-dockets">https://www.epa.gov/dockets/commenting-epa-dockets</a> for additional submission methods; the
full EPA public comment policy; information about CBI, PBI, or
multimedia submissions; and general guidance on making effective
comments.
FOR FURTHER INFORMATION CONTACT: Linda Longo, Air Programs Branch,
Environmental Protection Agency, 290 Broadway, New York, New York
10007-1866, at telephone number: (212) 637-3565, email address:
<a href="/cdn-cgi/l/email-protection#2d4142434a4203414443494c6d485d4c034a425b"><span class="__cf_email__" data-cfemail="e68a89888189c88a8f888287a6839687c8818990">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
Table of Contents
I. What is the background for this action?
II. What comments were received in response to the EPA's proposed
action?
III. What action is the EPA taking?
IV. Incorporation by Reference
V. Statutory and Executive Order Reviews
I. What is the background for this action?
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.\1\ 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.
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\1\ 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.
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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.\2\ 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.
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\2\ 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.
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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).
II. What comments were received in response to the EPA's proposed
action?
In response to the EPA's July 24, 2025 proposed rulemaking on New
York SIP revision submittal, the EPA received
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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 <a href="https://www.regulations.gov">https://www.regulations.gov</a> website.
III. What action is the EPA taking?
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.
IV. Incorporation by Reference
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
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.\3\
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\3\ 62 FR 27968 (May 22, 1997).
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V. Statutory and Executive Order Reviews
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:
<bullet> 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);
<bullet> Is not subject to Executive Order 14192 (90 FR 9065,
February 6, 2025) because SIP actions are exempt from review under
Executive Order 12866;
<bullet> Does not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);
<bullet> Is certified as not having a significant economic impact
on a substantial number of small entities under the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.);
<bullet> Does not contain any unfunded mandate or significantly or
uniquely affect small governments, as described in the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4);
<bullet> Does not have federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999);
<bullet> Is not subject to Executive Order 13045 (62 FR 19885,
April 23, 1997) because it approves a state program;
<bullet> Is not a significant regulatory action subject to
Executive Order 13211 (66 FR 28355, May 22, 2001); and
<bullet> Is not subject to requirements of section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272
note) because application of those requirements would be inconsistent
with the CAA.
In addition, the SIP is not approved to apply on any Indian
reservation land or in any other area where EPA or an Indian Tribe has
demonstrated that a Tribe has jurisdiction. In those areas of Indian
country, the rule does not have Tribal implications and will not impose
substantial direct costs on Tribal governments or preempt Tribal law as
specified by Executive Order 13175 (65 FR 67249, November 9, 2000).
This rule is exempt from the Congressional Review Act because it is
a rule of applicability.
Under section 307(b)(1) of the CAA, petitions for judicial review
of this action must be filed in the United States Court of Appeals for
the appropriate circuit by March 10, 2026. Filing a petition for
reconsideration by the Administrator of this final rule does not affect
the finality of this action for the purposes of judicial review nor
does it extend the time within which a petition for judicial review may
be filed, and shall not postpone the effectiveness of such rule or
action. This action may not be challenged later in proceedings to
enforce its requirements (see section 307(b)(2)).
List of Subjects 40 CFR Part 52
Environmental protection, Air pollution control, Incorporation by
reference, Intergovernmental relations, Ozone, Reporting and
recordkeeping requirements, Volatile organic compound.
Authority: 42 U.S.C. 7401 et seq.
Michael Martucci,
Regional Administrator, Region 2.
For the reasons set forth in the preamble, EPA amends 40 CFR part
52 as follows:
PART 52--APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS
0
1. The authority citation for part 52 continues to read as follows:
Authority: 42 U.S.C. 7401 et seq.
Subpart HH--New York
0
2. In Sec. 52.1670, the table in paragraph (d) is amended by adding
the entry ``Ortho Clinical Diagnostics'' at the end of the table to
read as follows:
Sec. 52.1670 Identification of plan.
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(d) * * *
EPA-Approved New York Source-Specific Provisions
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State effective
Name of source Identifier No. date EPA approval date Comments
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* * * * * * *
Ortho Clinical Diagnostics...... 8-2628-00503/02001 10/31/2022........ 1/9/2026.......... RACT emission
limit for
condition 13.
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[FR Doc. 2026-00281 Filed 1-8-26; 8:45 am]
BILLING CODE 6560-50-P
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