[Federal Register Volume 90, Number 140 (Thursday, July 24, 2025)]
[Proposed Rules]
[Pages 34781-34784]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2025-13937]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 52
[EPA-R02-OAR-2024-0494; FRL 12517-01-R2]
Air Plan Approval; New York; Ortho Clinical Diagnostics
AGENCY: Environmental Protection Agency (EPA).
ACTION: Proposed rule.
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SUMMARY: The Environmental Protection Agency (EPA) is proposing to
approve 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 is proposing to find 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 is intended to implement VOC
RACT for the relevant Facility source in accordance with the
requirements for implementation of the 2008 and 2015 ozone NAAQS. EPA
proposes to determine that this action will not interfere with ozone
NAAQS requirements and meets all applicable requirements of the Clean
Air Act (CAA).
DATES: Comments must be received on or before September 8, 2025.
ADDRESSES: Submit your comments, identified by Docket ID Number EPA-
R02-OAR-2024-0494 at https://
[[Page 34782]]
www.regulations.gov. Although listed in the index, some information is
not publicly available, e.g., Controlled Unclassified Information (CUI)
(formerly referred to as Confidential Business Information (CBI)) or
other information whose disclosure is restricted by statute. Certain
other material, such as copyrighted material, is not placed on the
internet and will be publicly available only in hard copy form.
Publicly available docket materials are available electronically
through https://www.regulations.gov. Follow the online instructions for
submitting comments. Once submitted, comments cannot be edited or
removed from Regulations.gov. The EPA may publish any comment received
to its public docket. Do not submit electronically any information you
consider to be CUI 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. The 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). For additional submission
methods, the full EPA public comment policy, information about CUI or
multimedia submissions, and general guidance on making effective
comments, please visit https://www.epa.gov/dockets/commenting-epa-dockets.
FOR FURTHER INFORMATION CONTACT: Linda Longo, Air Programs Branch,
Environmental Protection Agency, Region 2 Office, 290 Broadway, 25th
Floor, New York, New York 10007-1866, (212) 637-3565, or by email at
[email protected].
SUPPLEMENTARY INFORMATION: For additional information on regulatory
background and the EPA's technical findings relating to the Facility
RACT, the reader can refer to the Technical Support Document (TSD) that
is contained in the EPA docket assigned to this Federal Register
document.
Table of Contents
I. Background
II. The EPA's Evaluation of New York's Submission and RACT Analysis
III. Proposed Action
IV. Incorporation by Reference
V. Statutory and Executive Order Reviews
I. Background
Ground Level Ozone Formation
Ground level ozone is predominantly a secondary air pollutant
created by chemical reactions that occur when ozone precursors,
including nitrogen oxides (NOX) and volatile organic
compounds (VOC), chemically react in the presence of sunlight.\1\
Emissions from industrial facilities are anthropogenic sources of ozone
precursors. The potential for ground-level ozone formation tends to be
highest during months with warmer temperatures and stagnant air masses.
Ozone levels are thus generally higher during the summer months, which
is often referred to as ``the ozone season.'' In New York, the ozone
season is generally considered to be between April 15 and October 15,
while the non-ozone season is generally considered to be between
October 16 and April 14.
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\1\ Primary standards provide public health protection,
including protecting the health of ``sensitive'' populations such as
asthmatics, children, and the elderly. Secondary standards provide
public welfare protection, including protection against decreased
visibility and damage to animals, crops, vegetation, and buildings.
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Ozone Nonattainment
A geographic area of the United States that is not meeting the
primary or secondary National Ambient Air Quality Standard (NAAQS) for
ozone is described as a nonattainment area. Nonattainment areas are
classified as either Marginal, Moderate, Serious, Severe, or Extreme.
With respect to this proposed action, there are two relevant ozone
NAAQS standards. First, on March 12, 2008, the EPA promulgated a
revision to the ozone NAAQS, setting both the primary and secondary
standards at 0.075 parts per million (ppm) averaged over an 8-hour time
frame (2008 8-hour Ozone Standard). See 73 FR 16436 (March 27, 2008).
Second, on October 1, 2015, the EPA lowered these standards to 0.070
ppm averaged over an 8-hour time frame (2015 8-hour Ozone Standard).
See 80 FR 65292 (October 26, 2015). Under CAA section 184, the State of
New York is located within the Ozone Transport Region (OTR), which
means that it is subject to statewide RACT requirements. This facility
is not located in an ozone nonattainment area, but it is still required
to implement RACT because it is located within the OTR.
Federal RACT Requirements
RACT is defined as the lowest emission limit that a source is
capable of meeting through the application of control technology that
is reasonably available considering technological and economic
feasibility. CAA section 184(b)(2) sets forth the requirement to
establish control measures to implement RACT for major sources of VOC
located in the OTR. The State of New York is located within the OTR,
and thus the State is required to implement RACT for all major sources
of VOC within the State.
NYSDEC RACT Requirements
The New York State Department of Environmental Conservation
(NYSDEC) RACT regulations require applicable facilities to meet certain
requirements, referred to as ``presumptive RACT requirements.'' These
presumptive requirements generally require sources to implement
emission limits, control efficiency requirements, specific control
technologies, averaging plans, and/or fuel/raw material switching
practices. In some instances, the presumptive RACT requirements may not
be technologically or economically feasible for a certain source, and
the State can make a source-specific RACT determination, which is
submitted to the EPA as a SSSIP. The SSSIP should include the
facility's RACT plan that demonstrates how the facility will implement
RACT. The SSSIP will also include the applicable CAA operating permit
conditions that address RACT requirements. These permit conditions for
the Facility will become part of the Federally enforceable SIP upon the
EPA's final approval of this SSSIP.
Under existing NYSDEC RACT regulations, facilities are required to
assess all technologically feasible control options that meet the
State's cost threshold. The cost threshold for NYSDEC RACT requirements
is found under NYSDEC 2013 policy, ``DAR-20 Economic and Technical
Analysis for Reasonably Available Control Technology (RACT).'' Under
this policy, facilities must consider in their RACT determinations
control technologies that remove VOC or NOX emissions up to
a certain cost threshold, expressed in a dollar amount per ton of VOC
or NOX removed, which includes an inflation-adjusted
economic threshold.\2\
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\2\ The DAR-20 cost threshold is based on 1994 dollars. State of
New York relies on the U.S. Department of Labor, Bureau of Labor
Statistics inflationary calculator to adjust the RACT economic
feasibility threshold over time for inflation. See https://www.bls.gov/data/inflation_calculator.htm.
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II. The EPA's Evaluation of New York's Submission and RACT Analysis
This action relates to a SSSIP revision that concerns a web-based
film coating machine for in-vitro diagnostics dry slide technology
manufacturing operations. The source at issue in this action is for the
Facility's pilot coating machine (the 72 Machine) for research and
development of new potential products and material qualification
[[Page 34783]]
experiments of non-compliant coatings. The 72 Machine also manufactures
a small production run of equipment diagnostic calibration slides for
internal purposes only. The 72 Machine is in total enclosure. The
coating material is added to the process outside of the enclosed room
and no workers are permitted to enter the enclosed room. To minimize
VOC emissions, the overspray that can occur during coating operations
is controlled using film manufacturing technology appropriate for the
coating weight of the Ortho products. Generally, overspray can happen
during a coating operation when the coating is applied onto a film
substrate and if uncontrolled, overspray could generate excess VOC
emissions. The 72 Machine's VOC exhaust is emitted via the roof vent.
The NYSDEC RACT regulations establish RACT requirements for this
category of sources in 6 NYCRR part 228, ``Surface Coating Processes,
Commercial and Industrial Adhesives Sealants and Primers'', subpart
228-1, ``Surface Coating Processes'', subpart 228-1.5, ``Requirements
for Controlling VOC Emissions Using Add-On Controls or Coating
Systems,'' last approved into New York's SIP by the EPA on March 4,
2014. See 79 FR 12082 (March 4, 2014). The coating machine meets the
definition of a surface coating process under 6 NYCRR part 228-1
because it is a Class D coating line that applies solvent and aqueous
based coatings to a polyethylene terephthalate substrate to produce
testing slides.\3\ However, as explained above, the NYSDEC RACT
regulations allow source-specific RACT determinations if the
presumptive RACT requirements are not technologically or economically
feasible; such source-specific determinations must be submitted to the
EPA as a SSSIP.
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\3\ 6 NYCRR part 228-1.1, Table 1, identifies the Class D
coating line to include ``paper'', ``film'', and ``foil'' coating
lines in the town of Monroe. The Facility produces ``coil'' that is
similar to ``foil.'' Generally, coil is thicker than foil.
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This SSSIP was submitted by NYSDEC on April 7, 2023. In this SSSIP
submittal, the EPA has reviewed the RACT determination for 72 Machine
for consistency with the CAA and the EPA regulations, as interpreted
through EPA actions and guidance. The intended effect of this Source-
specific SIP revision is to establish an emission limit for the process
specific control measure for 72 Machine.
The EPA is proposing to determine through this SSSIP action that
the VOC RACT emission limit submitted by the State in this SSSIP for 72
Machine is the lowest emission limit with the application of control
technology that is reasonably available given technological and
economic feasibility considerations. The respective VOC RACT 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 for the proposed coating machine referred to
as 72 Machine further described in EPA RACT Analysis below.
The Facility submitted a RACT demonstration, dated November 2021,
to the NYSDEC for the emission limit requirements, and NYSDEC reviewed
and approved the emission limit as adequately implementing RACT for the
source. NYSDEC then submitted the source-specific SIP revision package
at issue in this action for the EPA approval, and the EPA is proposing
to determine the respective emission limit as implementing RACT for
this source. The emission limit for the Facility will become part of
the Federally enforceable SIP upon the EPA's final approval of this
SSSIP.
EPA RACT Analysis
The following is a summary of the EPA's analysis of how the
proposed VOC emission limit implements RACT for the emission source 72
Machine. Further detail on this analysis is provided in the TSD
available in the docket for this rulemaking. The Facility's coating
machine, 72 Machine, is part of the coating line to produce testing
slides. As described above, the 72 Machine is characterized as a
surface coating process under subpart 228-1, ``Surface Coating
Processes''.
The RACT demonstration must show an alternate emission limit to
comprise RACT and a RACT variance can be requested pursuant to 6 NYCRR
subpart 228-1.5(e). Such a RACT variance can be approved if supported
by a RACT demonstration and submitted to the EPA for review as a SIP
revision.
The Facility's RACT demonstration shows that controlling the
overspray is the only VOC control technology that is technologically
and economically feasible for this facility, and that controlling the
overspray ensures the VOC emissions will not exceed 21,600 pounds per
year on a 12-month rolling total basis. 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.\4\
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\4\ Under 6 NYCRR 228-1.5(c), ``[t]he overall removal efficiency
of an air cleaning device used as a control strategy must be
determined, for every surface coating formulation, on a solids as
applied basis using Equation 2 unless a 90 percent or greater
overall removal efficiency is achieved by the air cleaning device.
The air cleaning device must be designed and operated to provide, at
a minimum, an overall removal efficiency of either 90 percent or as
determined by Equation 2.''
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NYSDEC reviewed the RACT demonstration and determined that the
alternate emission limit implements RACT for the 72 Machine.
Specifically, NYSDEC approved the following case-by-case emission
limit: (1) Aggregate VOC emissions from non-compliant coatings A1c,
49CKMB, 90WHT, 92BLK on 72 Machine must not exceed 21,600 pounds per
year on a 12-month rolling total basis; (2) ensure that non-compliant
coatings A1c, 49CKMB, 90WHT, 92BLK have the same specifications as
described in the November 2021 RACT demonstration; (3) track usage
monthly and report compliance status on an annual basis; (4) failure to
meet the pounds per year limit established for this RACT variance shall
be ground for termination of the RACT variance; (5) a RACT variance
evaluation must be reassessed every five years; and (6) an updated RACT
variance request must be submitted by the facility for any changes that
will increase the emission rate of 72 Machine, including but not
limited to changes to coating specification, coating machine operation
parameters, or coating curing/drying time.
We are proposing to determine that the following additional
technically feasible control options do not need to be implemented
because they are not cost effective: (1) thermal oxidation; (2)
catalytic oxidation; and (3) ducting the VOC exhaust from 72 Machine to
the Facility's other coating machine (71 Machine \5\).
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\5\ The Facility operates a second coating machine, 71 Machine,
that is not subject to this rulemaking because it currently employs
a catalytic oxidizer with a heat exchanger and meets the presumptive
VOC limits under permit Condition 36.
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To determine what VOC control technologies could be economically
and technologically feasible for the 72 Machine, the EPA reviewed the
Reasonably Available Control Technology/Best Available Control
Technology/Lowest Achievable Emission Rate Clearinghouse (RBLC) \6\
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and the vendor quotes provided by the State as part of the RACT
evaluation. The EPA's RBLC search criteria were based on the process
type ``Paper, Plastic, and Foil Web Surface Coating.'' The EPA's RBLC
review reveals that there are three facilities in the United States
that possibly operate with similar practices as 72 Machine: (1) Bemis
Performance Packaging in Wisconsin manufactures flexible packing film
and has a regenerative thermal oxidizer on a flexographic press
machine; (2) American Packaging Corp in New York manufactures packaging
material for the food industry and has a regenerative thermal oxidizer
on a press machine; and (3) Benis in Indiana is a polyethylene film
plant and has a cyrel plate making process with a catalytic and
regenerative thermal oxidizer. The EPA also reviewed four vendor quotes
for the thermal and catalytic oxidizers as contained in the SSSIP
submission, and they appear to be technically sound. A vendor quote was
not provided for ducting the emissions from 72 Machine to 71 Machine
because ducting is not a reliable option due to the following: (1)
ducting would involve complicated planning for coating schedules, and
the two machines would not be able to operate at the same time due to
incompatible static pressure between both machines, and (2) ducting
emissions from 72 Machine to 71 Machine would result in overall airflow
to exceed the design capacity of the existing catalytic oxidizer on 71
Machine. The EPA confirms that no cost-effective VOC control
technologies have become available that could be implemented on the
Facility's 72 Machine. Further detail on RBLC results and cost
effectiveness are provided in the TSD available in docket for this
rulemaking.
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\6\ The RBLC contains case-specific information on the best
available air pollution technologies that have been required to
reduce the emission of air pollutants from stationary sources. See
https://cfpub.epa.gov/rblc/index.cfm?action=Search.BasicSearch&lang=en.
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The EPA is proposing to determine that the proposed limit for 72
Machine implements RACT because: (1) The 6 NYCRR part 228-1 presumptive
VOC limit for Class D coating line (i.e., paper, film, and foil) of
0.08 pounds VOC per pound coating is not economically and
technologically feasible for this source; (2) no additional control
technologies beyond what are currently used at 72 Machine are
technically and economically feasible; (3) emission limit of 21,600
pounds per year on a 12-month rolling total basis comprises RACT for
this source; and (4) the SIP revision contains monitoring and reporting
requirements.
III. Proposed Action
The EPA is proposing to approve this source-specific revision
because the limits included in the SSSIP implement RACT for 72 Machine.
Based on information provided by NYSDEC, a thorough RBLC review of
similar sources, and an analysis of this source-specific SIP revision,
the EPA proposes to approve Ortho Clinical Diagnostics operation under
the NYSDEC-approved VOC emission limit for the Facility's 72 Machine.
Specifically, the EPA proposes to determine the following SSSIP
revision: (1) The aggregate VOC emissions from non-compliant coatings
A1c, 49CKMB, 90WHT and 92BLK on 72 Machine must not exceed 21,600
pounds per year on a 12-month rolling total basis; (2) ensure that the
non-compliant coatings have the same specifications as described in the
RACT variance submitted November 2021; (3) track usage monthly and
report compliance annually; (4) exceeding the 21,600 pounds per year
limit shall be ground for termination of the RACT variance; (5) an
updated RACT variance request must be submitted for any changes that
will increase the emission rate, including but not limited to changes
to coating specification, coating machine operation parameters, or
coating curing/drying time; and (6) RACT must be reevaluated every 5
years and an updated RACT variance must be submitted every 5 years.
IV. Incorporation by Reference
In this document, the EPA is proposing to include regulatory text
that includes incorporation by reference. In accordance with
requirements of 1 CFR 51.5, the EPA is proposing to incorporate by
reference revisions to Ortho Clinical Diagnostics State Facility Permit
condition 13 as described in section II of this preamble. The EPA has
made, and will continue to make, these materials generally available
through www.regulations.gov.
V. Statutory and Executive Order Reviews
Under the Clean Air Act, the Administrator is required to approve a
SIP submission that complies with the provisions of the Clean Air Act
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 Clean Air Act.
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 Orders 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 et seq.);
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.);
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);
Does not have federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999);
Is not subject to Executive Order 13045 (62 FR 19885,
April 23, 1997) because it approves a state program;
Is not a significant regulatory action subject to
Executive Order 13211 (66 FR 28355, May 22, 2001); and
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 Clean Air Act.
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).
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.
[FR Doc. 2025-13937 Filed 7-23-25; 8:45 am]
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