Outer Continental Shelf Air Regulations; Consistency Update for New York, 56277-56280 [2022-19782]
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Federal Register / Vol. 87, No. 177 / Wednesday, September 14, 2022 / Rules and Regulations
(5) Manufacturer or sponsor. A
manufacturer or sponsor is the person
who:
(i) Meets the definition of ‘‘sponsor’’
in § 312.3 of this chapter for the eligible
investigational drug;
(ii) Has submitted an application for
the eligible investigational drug under
section 505(b) of the Federal Food,
Drug, and Cosmetic Act or section
351(a) of the Public Health Service Act;
or
(iii) Is other than a contract
manufacturer acting on behalf of a
manufacturer or sponsor, producing the
eligible investigational drug provided to
an eligible patient on behalf of the
persons described in paragraph (a)(5)(i)
or (ii) of this section.
(b)(1) Except as described in
paragraph (b)(2) of this section, a
manufacturer or sponsor of an eligible
investigational drug shall submit to the
Food and Drug Administration (FDA),
no later than March 31 of each year, an
annual summary of any use of eligible
investigational drugs supplied to any
eligible patient under section 561B of
the Federal Food, Drug, and Cosmetic
Act for the period of January 1 through
December 31 of the preceding year.
(2) For a manufacturer or sponsor of
an eligible investigational drug that has
supplied an eligible patient with an
eligible investigational drug under
section 561B of the Federal Food, Drug,
and Cosmetic Act between the period
from enactment of section 561B (May
30, 2018) and December 31, 2022, the
manufacturer or sponsor shall submit to
FDA a first annual summary covering
that period no later than March 31,
2023.
(c) For each eligible investigational
drug, the annual summary must
include:
(1) The name of the eligible
investigational drug and applicable IND
number. The name and IND number of
the eligible investigational drug
supplied by the manufacturer or
sponsor for use under section 561B of
the Federal Food, Drug, and Cosmetic
Act.
(2) Number of doses supplied. The
total number of doses supplied by the
manufacturer or sponsor to eligible
patients for use under section 561B of
the Federal Food, Drug, and Cosmetic
Act. Each dose of an eligible
investigational drug supplied for an
eligible patient shall be counted as a
dose supplied.
(3) Number of patients treated. The
total number of eligible patients for
whom the manufacturer or sponsor
provided the eligible investigational
drug for use under section 561B of the
Federal Food, Drug, and Cosmetic Act.
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An eligible patient treated more than
one time or with multiple doses of an
eligible investigational drug shall be
counted as a single patient.
(4) Use for which the eligible
investigational drug was made
available. A tabular summary
identifying the diseases or conditions
for which the eligible investigational
drug was made available for use under
section 561B of the Federal Food, Drug,
and Cosmetic Act.
(5) Any known serious adverse events
and outcomes. A tabular summary of
any known serious adverse events,
including resulting outcomes,
experienced by patients treated with the
eligible investigational drug under
section 561B of the Federal Food, Drug,
and Cosmetic Act.
(d) Annual summaries submitted
pursuant to this section shall be
submitted in an electronic format that
FDA can process, review, and archive,
and shall be sent directly to a
designated point of contact for
submissions made under section 561B
of the Federal Food, Drug, and Cosmetic
Act. The annual summaries must be
submitted to the designated point of
contact and shall not be submitted to a
particular investigational new drug
application. FDA will specify the
designated point of contact for
submission of the annual summary on
FDA’s website, as described at https://
www.fda.gov.
Dated: August 31, 2022.
Robert M. Califf,
Commissioner of Food and Drugs.
[FR Doc. 2022–19737 Filed 9–13–22; 8:45 am]
BILLING CODE 4164–01–P
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 55
[EPA–R02–OAR–2022–0400; FRL 9785–02–
R2]
Outer Continental Shelf Air
Regulations; Consistency Update for
New York
Environmental Protection
Agency.
ACTION: Final rule.
AGENCY:
The Environmental Protection
Agency (EPA) is finalizing an update to
a portion of the Outer Continental Shelf
(OCS) Air Regulations. Requirements
applying to OCS sources located within
25 miles of states’ seaward boundaries
must be updated periodically to remain
consistent with the requirements of the
corresponding onshore area (COA), as
SUMMARY:
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mandated by the Clean Air Act (CAA).
The portion of the OCS air regulations
that is being updated here pertains to
the requirements for OCS sources for
which the State of New York is the
COA. The intended effect of updating
the OCS requirements for the State of
New York is to regulate emissions from
OCS sources in accordance with the
requirements onshore. The requirements
discussed in this rule are being
incorporated by reference into the OCS
air regulations.
DATES: This final rule is effective on
October 14, 2022. The incorporation by
reference of a certain publication listed
in this rule is approved by the Director
of the Federal Register as of October 14,
2022.
ADDRESSES: The EPA has established a
docket for this action under Docket ID
Number EPA–R02–OAR–2022–0400. All
documents in the docket are available at
www.regulations.gov.
FOR FURTHER INFORMATION CONTACT:
Viorica Petriman, Air Programs Branch,
Permitting Section, U.S. Environmental
Protection Agency, Region 2, 290
Broadway, New York, New York 10007,
(212) 637–4021, petriman.viorica@
epa.gov.
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
VI. Judicial Review
I. What is the background for this
action?
On May 20, 2022 (87 FR 30849), EPA
proposed to incorporate by reference
into the OCS Air regulations at 40 CFR
part 55 1 updated requirements
pertaining to New York. See 87 FR
30849. The action that EPA is taking in
this rule is to finalize those proposed
updates. Section 328(a) of the CAA
requires that for OCS sources located
within 25 miles of a State’s seaward
boundary, the requirements shall be the
same as would be applicable if the
sources were located in the
corresponding onshore area (COA).
Because the OCS requirements are based
on onshore requirements, and onshore
requirements may change, CAA section
328(a)(1) requires that the EPA update
1 EPA promulgated 40 CFR part 55 on September
4, 1992. The reader may refer to the proposed
rulemaking to promulgate part 55 from 56 FR 63774
(December 5, 1991) and the preamble to the final
rule promulgated 57 FR 40792 (September 4, 1992)
for further background and information on the OCS
regulations.
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the OCS requirements as necessary to
maintain consistency with onshore
requirements.
To comply with this statutory
mandate, the EPA must incorporate by
reference into part 55 all relevant State
rules in effect for onshore sources, so
they can be applied to OCS sources
located offshore. This limits EPA’s
flexibility in deciding which
requirements will be incorporated into
40 CFR part 55 and prevents EPA from
making substantive changes to the
requirements it incorporates. As a
result, EPA may be incorporating rules
into 40 CFR part 55 that do not conform
to all of EPA’s state implementation
plan (SIP) guidance or certain
requirements of the CAA. Inclusion in
the OCS rules does not imply that a rule
meets the requirements of the CAA for
SIP approval, nor does it imply that the
rule will be approved by EPA for
inclusion in the SIP.
40 CFR 55.12 specifies certain times
at which part 55’s incorporation by
reference of a State’s rules must be
updated. One time such a ‘‘consistency
update’’ must occur is when any OCS
source applicant submits a Notice of
Intent (NOI) under 40 CFR 55.4 for a
new or a modified OCS source. 40 CFR
55.4(a) requires that any OCS source
applicant must submit to EPA a NOI
before performing any physical change
or change in method of operation that
results in an increase in emissions. EPA
must conduct any necessary consistency
update when it receives a NOI, and
prior to receiving any application for a
preconstruction permit from the OCS
source applicant. 40 CFR 55.6(b)(2) and
55.12(f).
On March 14, 2022, the EPA received
a NOI from Empire Offshore Wind LLC
to submit an OCS air permit application
for the construction and operation of a
new OCS source (a wind energy project)
about 14 miles offshore New York.
The EPA reviewed the New York
State Department of Environmental
Conservation (‘‘NYSDEC’’) air rules
currently in effect, to ensure that they
are rationally related to the attainment
or maintenance of Federal and State
Ambient Air Quality Standards (AAQS)
or part C of title I of the CAA, that they
are not designed expressly to prevent
exploration and development of the
OCS, and that they are applicable to
OCS sources. See 40 CFR 55.1. The EPA
has also evaluated the rules to ensure
they are not arbitrary and capricious.
See 40 CFR 55.12(e). The EPA has
excluded New York’s administrative or
procedural rules,2 and requirements that
2 Each COA which has been delegated the
authority to implement and enforce part 55, will
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regulate toxics which are not related to
the attainment and maintenance of
Federal and State AAQS.
II. What comments were received in
response to the EPA’s proposed action?
The EPA did not receive any
comments on the proposal to update a
portion of the OCS Air Regulations to
incorporate updated requirements into
40 CFR part 55 pertaining to the State
of New York.
III. What action is the EPA taking?
The EPA is taking final action to
incorporate by reference relevant New
York air pollution control rules into
§ 55.14 and to update the ‘‘New York’’
section of appendix A to 40 CFR part 55,
which lists those rules. The EPA is
approving this action under section
328(a) of the CAA, 42 U.S.C. 7627(a).
Section 328(a) of the CAA requires that
EPA establish requirements to control
air pollution from OCS sources located
within 25 miles of States’ seaward
boundaries that are the same as onshore
requirements. To comply with this
statutory mandate, the EPA must
incorporate applicable onshore rules
into 40 CFR part 55 as they exist
onshore.
IV. Incorporation by Reference
In this rule, the EPA is finalizing
regulatory text that includes
incorporation by reference as described
in sections I. and II. of this preamble. In
accordance with the requirements of 1
CFR 51.5, the EPA is finalizing the
incorporation by reference of ‘‘State of
New York Requirements Applicable to
OCS Sources,’’ dated March 10, 2022,
which provides the text of the NYSDEC
air rules in effect as of March 10, 2022
that would apply to OCS sources. The
EPA has made, and will continue to
make, this material available through
www.regulations.gov and at the EPA
Region 2 Office (please contact the
person identified in the FOR FURTHER
INFORMATION CONTACT section of this
preamble for more information).
V. Statutory and Executive Order
Reviews
Under the Clean Air Act, the
Administrator is required to establish
requirements to control air pollution
from OCS sources located within 25
miles of states’ seaward boundaries that
are the same as onshore air control
use its administrative and procedural rules as
onshore. However, in those instances where EPA
has not delegated authority to implement and
enforce part 55, as in New York, EPA will use its
own administrative and procedural requirements to
implement the substantive requirements. See 40
CFR 55.14(c)(4).
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requirements. To comply with this
statutory mandate, the EPA must
incorporate applicable onshore rules
into part 55 as they exist onshore. 42
U.S.C. 7627(a)(1); 40 CFR 55.12. Thus,
in promulgating OCS consistency
updates, the EPA’s role is to maintain
consistency between OCS regulations
and the regulations of onshore areas,
provided that they meet the criteria of
the Clean Air Act. Accordingly, this
action simply updates the existing OCS
requirements to make them consistent
with requirements onshore, without the
exercise of any policy discretion by the
EPA.
a. Executive Order 12866, Regulatory
Planning and Review
This action is not a ‘‘significant
regulatory action’’ under the terms of
Executive Orders (E.O.) 12866 (58 FR
51735, October 4, 1993) and 13563 (76
FR 3821, January 21, 2011) and is
therefore not subject to review under the
E.O.
b. Paperwork Reduction Act (PRA)
This action does not impose any new
information collection burden under
PRA because this action only updates
the State rules that are incorporated by
reference into 40 CFR part 55. OMB has
previously approved the information
collection activities contained in the
existing regulations at 40 CFR part 55
and, by extension, this update to part
55, and has assigned OMB control
number 2060–0249. This action does
not impose a new information burden
under PRA because this action only
updates the state rules that are
incorporated by reference into 40 CFR
part 55.
c. Regulatory Flexibility Act (RFA)
I certify that this action does not have
a significant impact on a substantial
number of small entities under the RFA.
This final rule does not impose any
requirements or create impacts on small
entities. This consistency update under
CAA section 328 does not create any
new requirements but simply updates
the State requirements incorporated by
reference into 40 CFR part 55 to match
the current State requirements.
d. Unfunded Mandates Reform Act
(UMRA)
This action does not contain any
unfunded mandate or significantly or
uniquely affect small governments as
described in UMRA, 2 U.S.C. 1531–
1538. The action imposes no
enforceable duty on any state, local or
tribal governments.
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e. Executive Order 13132, Federalism
This action does not have federalism
implications. It does not have
substantial direct effects on the states,
on the relationship between the national
government and the states, or on the
distribution of power and
responsibilities among the various
levels of government.
f. Executive Order 13175, Coordination
With Indian Tribal Governments
This action does not have tribal
implications, as specified in Executive
Order 13175 (65 FR 67249, November 9,
2000), because it does not have a
substantial direct effect on one or more
Indian tribes, on the relationship
between the Federal Government and
Indian tribes, or on the distribution of
power and responsibilities between the
Federal Government and Indian tribes,
nor does it impose substantial direct
costs on tribal governments, nor
preempt tribal law. It merely updates
the State requirements incorporated by
reference into 40 CFR part 55 to match
current State requirements.
g. Executive Order 13045, Protection of
Children From Environmental Health
Risks and Safety Risks
EPA interprets Executive Order 13045
as applying only to those regulatory
actions that concern health or safety
risks that the EPA has reason to believe
may disproportionately affect children,
per the definition of ‘‘covered regulatory
action’’ in section 2–202 of the
Executive Order. This action is not
subject to Executive Order 13045
because it is not an economically
significant regulatory action based on
health or safety risks subject to
Executive Order 13045 and simply
updates the State requirements
incorporated by reference into 40 CFR
part 55 to match the current State
requirements.
h. Executive Order 13211, Actions That
Significantly Affect Energy Supply,
Distribution, or Use
This final rule is not subject to
Executive Order 13211 because it is not
a significant regulatory action under
Executive Order 12866.
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i. National Technology Transfer and
Advancement Act
This rulemaking 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 is inconsistent with the
Clean Air Act.
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j. Executive Order 12898: Federal
Actions To Address Environmental
Justice in Minority Populations and
Low-Income Population
The EPA believes that this action is
not subject to Executive Order 12898 (59
FR 7629, February 16, 1994) because it
does not provide the EPA with the
discretionary authority to address, as
appropriate, disproportionate human
health, or environmental effects, using
practicable and legally permissible
methods.
k. Congressional Review Act (CRA)
The Congressional Review Act, 5
U.S.C. 801 et seq., as added by the Small
Business Regulatory Enforcement
Fairness Act of 1996, generally provides
that before a rule may take effect, the
agency promulgating the rule must
submit a rule report, which includes a
copy of the rule, to each House of the
Congress and to the Comptroller General
of the United States. EPA will submit a
report containing this action and other
required information to the U.S. Senate,
the U.S. House of Representatives, and
the Comptroller General of the United
States prior to publication of the rule in
the Federal Register. A major rule
cannot take effect until 60 days after it
is published in the Federal Register.
This action is not a ‘‘major rule’’ as
defined by 5 U.S.C. 804(2).
VI. Judicial Review
Under section 307(b)(1) of the Clean
Air Act, petitions for judicial review of
this action must be filed in the United
States Court of Appeals for the
appropriate circuit by November 14,
2022. 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 CAA
section 307(b)(2).
List of Subjects in 40 CFR Part 55
Environmental protection,
Administrative practice and procedures,
Air pollution control, Hydrocarbons,
Incorporation by reference,
Intergovernmental relations, Nitrogen
dioxide, Nitrogen oxides, Outer
Continental Shelf, Ozone, Particulate
matter, Permits, Reporting and
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56279
recordkeeping requirements, Sulfur
oxides.
Lisa Garcia,
Regional Administrator, Region 2.
For the reasons set out in the
preamble, 40 CFR part 55, is amended
as follows.
PART 55—OUTER CONTINENTAL
SHELF AIR REGULATIONS
1. The authority citation for part 55
continues to read as follows:
■
Authority: Section 328 of the Clean Air Act
(42 U.S.C. 7401, et seq.) as amended by Pub.
L. 101–549.
2. Section 55.14 is amended by
revising the paragraph (e)(16)(i)(A) to
read as follows:
■
§ 55.14 Requirements that apply to OCS
sources located within 25 miles of States’
seaward boundaries, by State.
*
*
*
*
*
(e) * * *
(16) * * *
(i) * * *
(A) State of New York Requirements
Applicable to OCS Sources, March 10,
2022.
*
*
*
*
*
■ 3. Appendix A to 40 CFR part 55 is
amended by revising the entry for ‘‘New
York’’ to read as follows:
Appendix A to Part 55—Listing of State
and Local Requirements Incorporated
by Reference Into Part 55, by State
*
*
*
*
*
New York
(a) State requirements.
(1) The following State of New York
requirements are applicable to OCS Sources,
as of March 10, 2022. New York
Environmental Conservation Law—
Department of Environmental Conservation.
The following sections of Title 6, Chapter III:
Subchapter A. Prevention and Control of Air
Contamination and Air Pollution
Part 200. General Provisions
6 NYCRR 200.1. Definitions (effective 4/2/
2020)
6 NYCRR 200.3. False Statement (effective 6/
16/1972)
6 NYCRR 200.4. Severability (effective 8/9/
1984)
6 NYCRR 200.6. Acceptable Ambient Air
Quality (effective 4/6/1983)
6 NYCRR 200.7. Maintenance of Equipment
(effective 2/22/1979)
6 NYCRR 200.9. Referenced Material
(effective 2/11/2021)
Part 201. Permits and Certificates
6 NYCRR 201–1.1. Purpose and applicability
(effective 2/22/2013)
6 NYCRR 201–1.4. Malfunctions and startup/shutdown activities (effective 2/25/
2021)
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6 NYCRR 201–1.5. Emergency defense
(effective 2/25/2021)
6 NYCRR 201–1.7. Recycling and salvage
(effective 2/22/2013)
6 NYCRR 201–1.8. Prohibition of
reintroduction of collected contaminants
to the air (effective 2/22/2013)
6 NYCRR 201–1.11. Temporary emission
sources (effective 2/25/2021)
6 NYCRR 201–1.12. Suspension, reopening,
reissuance, modification, or revocation
of air permits (effective 2/25/2021)
6 NYCRR 201–2. Definitions (effective 2/25/
2021)
6 NYCRR 201–4. Minor Facility Registration
(effective 2/25/2021)
6 NYCRR 201–5. State Facility Permits
(effective 2/25/2021)
6 NYCRR 201–6. Title V Facility Permits
(effective 2/25/2021)
6 NYCRR 201–7. Federally Enforceable
Emission Caps (effective 2/25/2021)
6 NYCRR 201–8. General Permits (effective 2/
22/2013)
6 NYCRR 201–9. Tables (effective 2/25/2021)
Part 202. Emissions Verification
6 NYCRR 202–1. Emissions Testing,
Sampling and Analytical Determinations
(effective 9/30/2010)
6 NYCRR 202–2. Emission Statements
(effective 12/3/2020)
Part 207. Control Measures for an Air
Pollution Episode (effective 2/22/1979)
Part 211. General Prohibitions (effective 1/1/
2011)
Part 212. Process Operations (effective 6/13/
2015)
Part 215. Open Fires (effective 10/14/2009)
Part 219. Incinerators
6 NYCRR 219–1. Incineration—General
Provisions (effective 3/15/2020)
6 NYCRR 219–2. Municipal and Private Solid
Waste Incineration Facilities (effective 5/
21/2005)
6 NYCRR 219–10. Reasonably Available
Control Technology (RACT) For Oxides
of Nitrogen (NOX) at Municipal and
Private Solid Waste Incineration Units
(effective 3/15/2020)
Part 221. Asbestos-Containing Surface
Coating Material (effective 9/29/1972)
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Part 222. Distributed Generation Sources
(effective 3/26/2020)
Part 225. Fuel Consumption and Use
6 NYCRR 225–1. Fuel Composition and
Use—Sulfur Limitations (effective 2/4/
2021)
6 NYCRR 225–2. Fuel Composition and
Use—Waste Oil as a Fuel (effective 4/2/
2020)
6 NYCRR 225–3. Fuel Composition and
Use—Gasoline (effective 11/4/2001)
6 NYCRR 225–4. Motor Vehicle Diesel Fuel
(effective 5/8/2005)
Part 226. Solvent Metal Cleaning Processes
and Industrial Cleaning Solvents (effective
11/1/2019)
Part 227. Stationary Combustion Installations
6 NYCRR 227–1. Stationary Combustion
Installations (effective 2/25/2000)
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6 NYCRR 227–2. Reasonably Available
Control Technology (RACT) for Major
Facilities of Oxides of Nitrogen (NOX)
(effective 12/7/2019)
6 NYCRR 227–3. Ozone Season Oxides of
Nitrogen (NOx) Emission Limits for
Simple Cycle and Regenerative
Combustion Turbines (effective 1/16/
2020)
6 NYCRR 242–8. Monitoring and Reporting
(effective 12/31/2020)
6 NYCRR 242–10. CO2 Emissions Offset
Projects (effective 12/31/2020)
Part 243. CSAPR NOX Ozone Season Group
2 Trading Program (effective 1/2/2019)
Part 228. Surface Coating Processes,
Commercial and Industrial Adhesives,
Sealants and Primers (effective 6/5/2013)
Part 245. CSAPR SO2 Group 1 Trading
Program (effective 1/2/2019)
Part 229. Petroleum and Volatile Organic
Liquid Storage and Transfer (effective 4/4/
1993)
Part 230. Gasoline Dispensing Sites and
Transport Vehicles (effective 2/11/2021)
Part 231. New Source Review for New and
Modified Facilities
6 NYCRR 231–3. General Provisions
(effective 2/25/2021)
6 NYCRR 231–4. Definitions (effective 2/25/
2021)
6 NYCRR 231–5. New Major Facilities and
Modifications to Existing Non-Major
Facilities in Nonattainment Areas, and
Attainment Areas of the State Within the
Ozone Transport Region (effective 2/25/
2021)
6 NYCRR 231–6. Modifications to Existing
Major Facilities in Nonattainment Areas
and Attainment Areas of the State
Within the Ozone Transport Region
(effective 2/25/2021)
6 NYCRR 231–7. New Major Facilities and
Modifications to Existing Non-Major
Facilities in Attainment Areas
(Prevention of Significant Deterioration)
(effective 2/25/2021)
6 NYCRR 231–8. Modifications to Existing
Major Facilities in Attainment Areas
(Prevention of Significant Deterioration)
(effective 2/25/2021)
6 NYCRR 231–9. Plantwide Applicability
Limitation (PAL) (effective 2/25/2021)
6 NYCRR 231–10. Emission Reduction
Credits (ERCs) (effective 2/25/2021)
6 NYCRR 231–11. Permit and Reasonable
Possibility Requirements (effective 2/25/
2021)
6 NYCRR 231–12. Ambient Air Quality
Impact Analysis (effective 2/25/2021)
6 NYCRR 231–13. Tables and Emission
Thresholds (effective 2/25/2021)
Part 241. Asphalt Pavement and Asphalt
Based Surface Coating (effective 1/1/2011)
Part 242. CO2 Budget Trading Program
6 NYCRR 242–1. CO2 Budget Trading
Program General Provisions (effective
12/31/2020)
6 NYCRR 242–2. CO2 Authorized Account
Representative for CO2 Budget Sources
(effective 12/31/2020)
6 NYCRR 242–3. Permits (effective 1/1/2014)
6 NYCRR 242–4. Compliance Certification
(effective 1/1/2014)
6 NYCRR 242–5. CO2 Allowance Allocations
(effective 12/31/2020)
6 NYCRR 242–6. CO2 Allowance Tracking
System (effective 12/31/2020)
6 NYCRR 242–7. CO2 Allowance Transfers
(effective 1/1/2014)
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Part 244. CSAPR NOX Annual Trading
Program (effective 1/2/2019)
Subchapter B. Air Quality Classifications
and Standards
Part 256. Air Quality Classifications System
(effective 5/1/1972)
Part 257. Air Quality Standards
6 NYCRR 257–1. Air Quality StandardsGeneral (effective 12/6/2019)
6 NYCRR 257–2. Air Quality StandardsSulfur Dioxide (SO2) (effective 3/18/
1977)
6 NYCRR 257–3. Air Quality StandardsParticulates (effective 12/6/2019)
6 NYCRR 257–4. Ambient Air Quality
Standards-Fluorides (effective 12/6/
2019)
6 NYCRR 257–5. Ambient Air Quality
Standards-Hydrogen Sulfide (H2S)
(effective 12/6/2019)
Subchapter C. Air Quality Area
Classifications
Part 287. Nassau County (effective 5/1/1972)
Part 288. New York City (effective 5/1/1972)
Part 307. Suffolk County (effective 5/1/1972)
Part 315. Westchester County (effective 5/1/
1972)
*
*
*
*
*
[FR Doc. 2022–19782 Filed 9–13–22; 8:45 am]
BILLING CODE 6560–50–P
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[EPA–HQ–OPP–2020–0244; FRL–10167–01–
OCSPP]
Hypochlorous Acid; Exemption From
the Requirement of a Tolerance
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
The Environmental Protection
Agency (EPA) is exempting residues of
the antimicrobial pesticide ingredient
hypochlorous acid from the requirement
of a tolerance when used on or applied
to food-contact surfaces in public eating
places. The EPA is finalizing this rule
on its own initiative under the Federal
Food, Drug, and Cosmetic Act (FFDCA)
to address residues identified as part of
the EPA’s registration review program
under the Federal Insecticide,
SUMMARY:
E:\FR\FM\14SER1.SGM
14SER1
Agencies
[Federal Register Volume 87, Number 177 (Wednesday, September 14, 2022)]
[Rules and Regulations]
[Pages 56277-56280]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-19782]
=======================================================================
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 55
[EPA-R02-OAR-2022-0400; FRL 9785-02-R2]
Outer Continental Shelf Air Regulations; Consistency Update for
New York
AGENCY: Environmental Protection Agency.
ACTION: Final rule.
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SUMMARY: The Environmental Protection Agency (EPA) is finalizing an
update to a portion of the Outer Continental Shelf (OCS) Air
Regulations. Requirements applying to OCS sources located within 25
miles of states' seaward boundaries must be updated periodically to
remain consistent with the requirements of the corresponding onshore
area (COA), as mandated by the Clean Air Act (CAA). The portion of the
OCS air regulations that is being updated here pertains to the
requirements for OCS sources for which the State of New York is the
COA. The intended effect of updating the OCS requirements for the State
of New York is to regulate emissions from OCS sources in accordance
with the requirements onshore. The requirements discussed in this rule
are being incorporated by reference into the OCS air regulations.
DATES: This final rule is effective on October 14, 2022. The
incorporation by reference of a certain publication listed in this rule
is approved by the Director of the Federal Register as of October 14,
2022.
ADDRESSES: The EPA has established a docket for this action under
Docket ID Number EPA-R02-OAR-2022-0400. All documents in the docket are
available at www.regulations.gov.
FOR FURTHER INFORMATION CONTACT: Viorica Petriman, Air Programs Branch,
Permitting Section, U.S. Environmental Protection Agency, Region 2, 290
Broadway, New York, New York 10007, (212) 637-4021,
[email protected].
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
VI. Judicial Review
I. What is the background for this action?
On May 20, 2022 (87 FR 30849), EPA proposed to incorporate by
reference into the OCS Air regulations at 40 CFR part 55 \1\ updated
requirements pertaining to New York. See 87 FR 30849. The action that
EPA is taking in this rule is to finalize those proposed updates.
Section 328(a) of the CAA requires that for OCS sources located within
25 miles of a State's seaward boundary, the requirements shall be the
same as would be applicable if the sources were located in the
corresponding onshore area (COA). Because the OCS requirements are
based on onshore requirements, and onshore requirements may change, CAA
section 328(a)(1) requires that the EPA update
[[Page 56278]]
the OCS requirements as necessary to maintain consistency with onshore
requirements.
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\1\ EPA promulgated 40 CFR part 55 on September 4, 1992. The
reader may refer to the proposed rulemaking to promulgate part 55
from 56 FR 63774 (December 5, 1991) and the preamble to the final
rule promulgated 57 FR 40792 (September 4, 1992) for further
background and information on the OCS regulations.
---------------------------------------------------------------------------
To comply with this statutory mandate, the EPA must incorporate by
reference into part 55 all relevant State rules in effect for onshore
sources, so they can be applied to OCS sources located offshore. This
limits EPA's flexibility in deciding which requirements will be
incorporated into 40 CFR part 55 and prevents EPA from making
substantive changes to the requirements it incorporates. As a result,
EPA may be incorporating rules into 40 CFR part 55 that do not conform
to all of EPA's state implementation plan (SIP) guidance or certain
requirements of the CAA. Inclusion in the OCS rules does not imply that
a rule meets the requirements of the CAA for SIP approval, nor does it
imply that the rule will be approved by EPA for inclusion in the SIP.
40 CFR 55.12 specifies certain times at which part 55's
incorporation by reference of a State's rules must be updated. One time
such a ``consistency update'' must occur is when any OCS source
applicant submits a Notice of Intent (NOI) under 40 CFR 55.4 for a new
or a modified OCS source. 40 CFR 55.4(a) requires that any OCS source
applicant must submit to EPA a NOI before performing any physical
change or change in method of operation that results in an increase in
emissions. EPA must conduct any necessary consistency update when it
receives a NOI, and prior to receiving any application for a
preconstruction permit from the OCS source applicant. 40 CFR 55.6(b)(2)
and 55.12(f).
On March 14, 2022, the EPA received a NOI from Empire Offshore Wind
LLC to submit an OCS air permit application for the construction and
operation of a new OCS source (a wind energy project) about 14 miles
offshore New York.
The EPA reviewed the New York State Department of Environmental
Conservation (``NYSDEC'') air rules currently in effect, to ensure that
they are rationally related to the attainment or maintenance of Federal
and State Ambient Air Quality Standards (AAQS) or part C of title I of
the CAA, that they are not designed expressly to prevent exploration
and development of the OCS, and that they are applicable to OCS
sources. See 40 CFR 55.1. The EPA has also evaluated the rules to
ensure they are not arbitrary and capricious. See 40 CFR 55.12(e). The
EPA has excluded New York's administrative or procedural rules,\2\ and
requirements that regulate toxics which are not related to the
attainment and maintenance of Federal and State AAQS.
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\2\ Each COA which has been delegated the authority to implement
and enforce part 55, will use its administrative and procedural
rules as onshore. However, in those instances where EPA has not
delegated authority to implement and enforce part 55, as in New
York, EPA will use its own administrative and procedural
requirements to implement the substantive requirements. See 40 CFR
55.14(c)(4).
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II. What comments were received in response to the EPA's proposed
action?
The EPA did not receive any comments on the proposal to update a
portion of the OCS Air Regulations to incorporate updated requirements
into 40 CFR part 55 pertaining to the State of New York.
III. What action is the EPA taking?
The EPA is taking final action to incorporate by reference relevant
New York air pollution control rules into Sec. 55.14 and to update the
``New York'' section of appendix A to 40 CFR part 55, which lists those
rules. The EPA is approving this action under section 328(a) of the
CAA, 42 U.S.C. 7627(a). Section 328(a) of the CAA requires that EPA
establish requirements to control air pollution from OCS sources
located within 25 miles of States' seaward boundaries that are the same
as onshore requirements. To comply with this statutory mandate, the EPA
must incorporate applicable onshore rules into 40 CFR part 55 as they
exist onshore.
IV. Incorporation by Reference
In this rule, the EPA is finalizing regulatory text that includes
incorporation by reference as described in sections I. and II. of this
preamble. In accordance with the requirements of 1 CFR 51.5, the EPA is
finalizing the incorporation by reference of ``State of New York
Requirements Applicable to OCS Sources,'' dated March 10, 2022, which
provides the text of the NYSDEC air rules in effect as of March 10,
2022 that would apply to OCS sources. The EPA has made, and will
continue to make, this material available through www.regulations.gov
and at the EPA Region 2 Office (please contact the person identified in
the FOR FURTHER INFORMATION CONTACT section of this preamble for more
information).
V. Statutory and Executive Order Reviews
Under the Clean Air Act, the Administrator is required to establish
requirements to control air pollution from OCS sources located within
25 miles of states' seaward boundaries that are the same as onshore air
control requirements. To comply with this statutory mandate, the EPA
must incorporate applicable onshore rules into part 55 as they exist
onshore. 42 U.S.C. 7627(a)(1); 40 CFR 55.12. Thus, in promulgating OCS
consistency updates, the EPA's role is to maintain consistency between
OCS regulations and the regulations of onshore areas, provided that
they meet the criteria of the Clean Air Act. Accordingly, this action
simply updates the existing OCS requirements to make them consistent
with requirements onshore, without the exercise of any policy
discretion by the EPA.
a. Executive Order 12866, Regulatory Planning and Review
This action is not a ``significant regulatory action'' under the
terms of Executive Orders (E.O.) 12866 (58 FR 51735, October 4, 1993)
and 13563 (76 FR 3821, January 21, 2011) and is therefore not subject
to review under the E.O.
b. Paperwork Reduction Act (PRA)
This action does not impose any new information collection burden
under PRA because this action only updates the State rules that are
incorporated by reference into 40 CFR part 55. OMB has previously
approved the information collection activities contained in the
existing regulations at 40 CFR part 55 and, by extension, this update
to part 55, and has assigned OMB control number 2060-0249. This action
does not impose a new information burden under PRA because this action
only updates the state rules that are incorporated by reference into 40
CFR part 55.
c. Regulatory Flexibility Act (RFA)
I certify that this action does not have a significant impact on a
substantial number of small entities under the RFA. This final rule
does not impose any requirements or create impacts on small entities.
This consistency update under CAA section 328 does not create any new
requirements but simply updates the State requirements incorporated by
reference into 40 CFR part 55 to match the current State requirements.
d. Unfunded Mandates Reform Act (UMRA)
This action does not contain any unfunded mandate or significantly
or uniquely affect small governments as described in UMRA, 2 U.S.C.
1531-1538. The action imposes no enforceable duty on any state, local
or tribal governments.
[[Page 56279]]
e. Executive Order 13132, Federalism
This action does not have federalism implications. It does not have
substantial direct effects on the states, on the relationship between
the national government and the states, or on the distribution of power
and responsibilities among the various levels of government.
f. Executive Order 13175, Coordination With Indian Tribal Governments
This action does not have tribal implications, as specified in
Executive Order 13175 (65 FR 67249, November 9, 2000), because it does
not have a substantial direct effect on one or more Indian tribes, on
the relationship between the Federal Government and Indian tribes, or
on the distribution of power and responsibilities between the Federal
Government and Indian tribes, nor does it impose substantial direct
costs on tribal governments, nor preempt tribal law. It merely updates
the State requirements incorporated by reference into 40 CFR part 55 to
match current State requirements.
g. Executive Order 13045, Protection of Children From Environmental
Health Risks and Safety Risks
EPA interprets Executive Order 13045 as applying only to those
regulatory actions that concern health or safety risks that the EPA has
reason to believe may disproportionately affect children, per the
definition of ``covered regulatory action'' in section 2-202 of the
Executive Order. This action is not subject to Executive Order 13045
because it is not an economically significant regulatory action based
on health or safety risks subject to Executive Order 13045 and simply
updates the State requirements incorporated by reference into 40 CFR
part 55 to match the current State requirements.
h. Executive Order 13211, Actions That Significantly Affect Energy
Supply, Distribution, or Use
This final rule is not subject to Executive Order 13211 because it
is not a significant regulatory action under Executive Order 12866.
i. National Technology Transfer and Advancement Act
This rulemaking 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 is inconsistent
with the Clean Air Act.
j. Executive Order 12898: Federal Actions To Address Environmental
Justice in Minority Populations and Low-Income Population
The EPA believes that this action is not subject to Executive Order
12898 (59 FR 7629, February 16, 1994) because it does not provide the
EPA with the discretionary authority to address, as appropriate,
disproportionate human health, or environmental effects, using
practicable and legally permissible methods.
k. Congressional Review Act (CRA)
The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. EPA will submit a report containing this action and
other required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of the rule in the Federal Register. A major rule cannot
take effect until 60 days after it is published in the Federal
Register. This action is not a ``major rule'' as defined by 5 U.S.C.
804(2).
VI. Judicial Review
Under section 307(b)(1) of the Clean Air Act, petitions for
judicial review of this action must be filed in the United States Court
of Appeals for the appropriate circuit by November 14, 2022. 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 CAA section 307(b)(2).
List of Subjects in 40 CFR Part 55
Environmental protection, Administrative practice and procedures,
Air pollution control, Hydrocarbons, Incorporation by reference,
Intergovernmental relations, Nitrogen dioxide, Nitrogen oxides, Outer
Continental Shelf, Ozone, Particulate matter, Permits, Reporting and
recordkeeping requirements, Sulfur oxides.
Lisa Garcia,
Regional Administrator, Region 2.
For the reasons set out in the preamble, 40 CFR part 55, is amended
as follows.
PART 55--OUTER CONTINENTAL SHELF AIR REGULATIONS
0
1. The authority citation for part 55 continues to read as follows:
Authority: Section 328 of the Clean Air Act (42 U.S.C. 7401, et
seq.) as amended by Pub. L. 101-549.
0
2. Section 55.14 is amended by revising the paragraph (e)(16)(i)(A) to
read as follows:
Sec. 55.14 Requirements that apply to OCS sources located within 25
miles of States' seaward boundaries, by State.
* * * * *
(e) * * *
(16) * * *
(i) * * *
(A) State of New York Requirements Applicable to OCS Sources, March
10, 2022.
* * * * *
0
3. Appendix A to 40 CFR part 55 is amended by revising the entry for
``New York'' to read as follows:
Appendix A to Part 55--Listing of State and Local Requirements
Incorporated by Reference Into Part 55, by State
* * * * *
New York
(a) State requirements.
(1) The following State of New York requirements are applicable
to OCS Sources, as of March 10, 2022. New York Environmental
Conservation Law--Department of Environmental Conservation. The
following sections of Title 6, Chapter III:
Subchapter A. Prevention and Control of Air Contamination and Air
Pollution
Part 200. General Provisions
6 NYCRR 200.1. Definitions (effective 4/2/2020)
6 NYCRR 200.3. False Statement (effective 6/16/1972)
6 NYCRR 200.4. Severability (effective 8/9/1984)
6 NYCRR 200.6. Acceptable Ambient Air Quality (effective 4/6/1983)
6 NYCRR 200.7. Maintenance of Equipment (effective 2/22/1979)
6 NYCRR 200.9. Referenced Material (effective 2/11/2021)
Part 201. Permits and Certificates
6 NYCRR 201-1.1. Purpose and applicability (effective 2/22/2013)
6 NYCRR 201-1.4. Malfunctions and start-up/shutdown activities
(effective 2/25/2021)
[[Page 56280]]
6 NYCRR 201-1.5. Emergency defense (effective 2/25/2021)
6 NYCRR 201-1.7. Recycling and salvage (effective 2/22/2013)
6 NYCRR 201-1.8. Prohibition of reintroduction of collected
contaminants to the air (effective 2/22/2013)
6 NYCRR 201-1.11. Temporary emission sources (effective 2/25/2021)
6 NYCRR 201-1.12. Suspension, reopening, reissuance, modification,
or revocation of air permits (effective 2/25/2021)
6 NYCRR 201-2. Definitions (effective 2/25/2021)
6 NYCRR 201-4. Minor Facility Registration (effective 2/25/2021)
6 NYCRR 201-5. State Facility Permits (effective 2/25/2021)
6 NYCRR 201-6. Title V Facility Permits (effective 2/25/2021)
6 NYCRR 201-7. Federally Enforceable Emission Caps (effective 2/25/
2021)
6 NYCRR 201-8. General Permits (effective 2/22/2013)
6 NYCRR 201-9. Tables (effective 2/25/2021)
Part 202. Emissions Verification
6 NYCRR 202-1. Emissions Testing, Sampling and Analytical
Determinations (effective 9/30/2010)
6 NYCRR 202-2. Emission Statements (effective 12/3/2020)
Part 207. Control Measures for an Air Pollution Episode (effective 2/
22/1979)
Part 211. General Prohibitions (effective 1/1/2011)
Part 212. Process Operations (effective 6/13/2015)
Part 215. Open Fires (effective 10/14/2009)
Part 219. Incinerators
6 NYCRR 219-1. Incineration--General Provisions (effective 3/15/
2020)
6 NYCRR 219-2. Municipal and Private Solid Waste Incineration
Facilities (effective 5/21/2005)
6 NYCRR 219-10. Reasonably Available Control Technology (RACT) For
Oxides of Nitrogen (NOX) at Municipal and Private Solid
Waste Incineration Units (effective 3/15/2020)
Part 221. Asbestos-Containing Surface Coating Material (effective 9/29/
1972)
Part 222. Distributed Generation Sources (effective 3/26/2020)
Part 225. Fuel Consumption and Use
6 NYCRR 225-1. Fuel Composition and Use--Sulfur Limitations
(effective 2/4/2021)
6 NYCRR 225-2. Fuel Composition and Use--Waste Oil as a Fuel
(effective 4/2/2020)
6 NYCRR 225-3. Fuel Composition and Use--Gasoline (effective 11/4/
2001)
6 NYCRR 225-4. Motor Vehicle Diesel Fuel (effective 5/8/2005)
Part 226. Solvent Metal Cleaning Processes and Industrial Cleaning
Solvents (effective 11/1/2019)
Part 227. Stationary Combustion Installations
6 NYCRR 227-1. Stationary Combustion Installations (effective 2/25/
2000)
6 NYCRR 227-2. Reasonably Available Control Technology (RACT) for
Major Facilities of Oxides of Nitrogen (NOX) (effective
12/7/2019)
6 NYCRR 227-3. Ozone Season Oxides of Nitrogen (NOx) Emission Limits
for Simple Cycle and Regenerative Combustion Turbines (effective 1/
16/2020)
Part 228. Surface Coating Processes, Commercial and Industrial
Adhesives, Sealants and Primers (effective 6/5/2013)
Part 229. Petroleum and Volatile Organic Liquid Storage and Transfer
(effective 4/4/1993)
Part 230. Gasoline Dispensing Sites and Transport Vehicles (effective
2/11/2021)
Part 231. New Source Review for New and Modified Facilities
6 NYCRR 231-3. General Provisions (effective 2/25/2021)
6 NYCRR 231-4. Definitions (effective 2/25/2021)
6 NYCRR 231-5. New Major Facilities and Modifications to Existing
Non-Major Facilities in Nonattainment Areas, and Attainment Areas of
the State Within the Ozone Transport Region (effective 2/25/2021)
6 NYCRR 231-6. Modifications to Existing Major Facilities in
Nonattainment Areas and Attainment Areas of the State Within the
Ozone Transport Region (effective 2/25/2021)
6 NYCRR 231-7. New Major Facilities and Modifications to Existing
Non-Major Facilities in Attainment Areas (Prevention of Significant
Deterioration) (effective 2/25/2021)
6 NYCRR 231-8. Modifications to Existing Major Facilities in
Attainment Areas (Prevention of Significant Deterioration)
(effective 2/25/2021)
6 NYCRR 231-9. Plantwide Applicability Limitation (PAL) (effective
2/25/2021)
6 NYCRR 231-10. Emission Reduction Credits (ERCs) (effective 2/25/
2021)
6 NYCRR 231-11. Permit and Reasonable Possibility Requirements
(effective 2/25/2021)
6 NYCRR 231-12. Ambient Air Quality Impact Analysis (effective 2/25/
2021)
6 NYCRR 231-13. Tables and Emission Thresholds (effective 2/25/2021)
Part 241. Asphalt Pavement and Asphalt Based Surface Coating (effective
1/1/2011)
Part 242. CO2 Budget Trading Program
6 NYCRR 242-1. CO2 Budget Trading Program General
Provisions (effective 12/31/2020)
6 NYCRR 242-2. CO2 Authorized Account Representative for
CO2 Budget Sources (effective 12/31/2020)
6 NYCRR 242-3. Permits (effective 1/1/2014)
6 NYCRR 242-4. Compliance Certification (effective 1/1/2014)
6 NYCRR 242-5. CO2 Allowance Allocations (effective 12/
31/2020)
6 NYCRR 242-6. CO2 Allowance Tracking System (effective
12/31/2020)
6 NYCRR 242-7. CO2 Allowance Transfers (effective 1/1/
2014)
6 NYCRR 242-8. Monitoring and Reporting (effective 12/31/2020)
6 NYCRR 242-10. CO2 Emissions Offset Projects (effective
12/31/2020)
Part 243. CSAPR NOX Ozone Season Group 2 Trading Program
(effective 1/2/2019)
Part 244. CSAPR NOX Annual Trading Program (effective 1/2/
2019)
Part 245. CSAPR SO2 Group 1 Trading Program (effective 1/2/
2019)
Subchapter B. Air Quality Classifications and Standards
Part 256. Air Quality Classifications System (effective 5/1/1972)
Part 257. Air Quality Standards
6 NYCRR 257-1. Air Quality Standards-General (effective 12/6/2019)
6 NYCRR 257-2. Air Quality Standards-Sulfur Dioxide (SO2)
(effective 3/18/1977)
6 NYCRR 257-3. Air Quality Standards-Particulates (effective 12/6/
2019)
6 NYCRR 257-4. Ambient Air Quality Standards-Fluorides (effective
12/6/2019)
6 NYCRR 257-5. Ambient Air Quality Standards-Hydrogen Sulfide
(H2S) (effective 12/6/2019)
Subchapter C. Air Quality Area Classifications
Part 287. Nassau County (effective 5/1/1972)
Part 288. New York City (effective 5/1/1972)
Part 307. Suffolk County (effective 5/1/1972)
Part 315. Westchester County (effective 5/1/1972)
* * * * *
[FR Doc. 2022-19782 Filed 9-13-22; 8:45 am]
BILLING CODE 6560-50-P