[Federal Register Volume 87, Number 20 (Monday, January 31, 2022)]
[Rules and Regulations]
[Pages 4812-4815]
[FR Doc No: 2022-01649]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Parts 52 and 81

[EPA-R07-OAR-2021-0667; FRL-9105-02-R7]

Air Plan Approval; Missouri Redesignation Request and Associated
Maintenance Plan for the Jackson County 2010 SO2 1-Hour NAAQS
Nonattainment Area

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: On February 18, 2021, the State of Missouri submitted a
request for the Environmental Protection Agency (EPA) to redesignate
the Jackson County, Missouri, 2010 1-hour sulfur dioxide
(SO2) National Ambient Air Quality Standard (NAAQS)
nonattainment area to attainment and approve a State Implementation
Plan (SIP) revision containing a maintenance plan for the area. The
State provided a supplement to the maintenance plan on

September 7, 2021. In response to these submittals, the EPA is taking
the following final actions: Approve the State's plan for maintaining
attainment of the 2010 1-hour SO2 primary standard in the
area; and approve the State's request to redesignate the Jackson County
SO2 nonattainment area to attainment for the 2010 1-hour
SO2 primary standard. This redesignation action addresses
the EPA's obligation under a consent decree which establishes a
deadline of March 31, 2022, for the EPA to determine under Clean Air
Act (CAA) section 179(c) whether the Jackson County SO2
nonattainment area attained the NAAQS by the October 4, 2018,
attainment date.

DATES: This final rule is effective on March 2, 2022.

ADDRESSES: The EPA has established a docket for this action under
Docket ID No. EPA-R07-OAR-2021-0667. All documents in the docket are
listed on the https://www.regulations.gov website. Although listed in
the index, some information is not publicly available, i.e.,
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 through https://www.regulations.gov or please
contact the person identified in the FOR FURTHER INFORMATION CONTACT
section for additional information.

FOR FURTHER INFORMATION CONTACT: Wendy Vit, Environmental Protection
Agency, Region 7 Office, Air Quality Planning Branch, 11201 Renner
Boulevard, Lenexa, Kansas 66219 at<PHONE_NUMBER> or by email at
[email protected].

SUPPLEMENTARY INFORMATION: Throughout this document ``we,'' ``us,'' and
``our'' refer to the EPA.

Table of Contents

I. What is being addressed in this document?
II. Have the requirements for approval of a SIP revision been met?
III. What are the actions the EPA is taking?
IV. Environmental Justice Concerns
V. Incorporation by Reference
VI. Statutory and Executive Order Reviews

I. What is being addressed in this document?

    On February 18, 2021, the State submitted a request for
redesignation of the Jackson County SO2 nonattainment area
to attainment and a SIP revision containing a 10-year maintenance plan
for the area. On September 7, 2021, the State submitted a supplement to
the maintenance plan consisting of a Consent Agreement between Missouri
and Vicinity Energy--Kansas City (Vicinity, formerly Veolia-Kansas
City) and an updated air dispersion modeling demonstration to support
the redesignation. The EPA's proposal at 86 FR 59075 [October 26, 2021]
discusses the EPA's review of the redesignation request, the
maintenance plan, and the maintenance plan supplement (including the
Consent Agreement and updated modeling demonstration) and provides
support for the EPA's proposed approval of the request to redesignate
the area to attainment and for proposed approval of the 10-year
maintenance plan. Additional analysis of the redesignation request, 10-
year maintenance plan, Consent Agreement, and supplemental modeling
information is provided in a Technical Support Document (TSD) included
in this docket. The public comment period on the EPA's proposed rule
opened on October 26, 2021, the date of its publication in the Federal
Register and closed on November 26, 2021. During this period, the EPA
received no comments.

II. Have the requirements for approval of a SIP revision been met?

    The State submission has met the public notice requirements for SIP
submissions in accordance with 40 CFR 51.102. The submission also
satisfied the completeness criteria of 40 CFR part 51, appendix V. The
State provided public notice on the February 2021 SIP submittal from
November 2, 2020, to December 10, 2020 and held a public hearing on
December 3, 2020. The State received and addressed three comments from
one source (the EPA). The State revised the maintenance plan based on
public comment prior to submitting it to the EPA. Missouri held a
public hearing for the September 2021 maintenance plan supplement on
July 29, 2021, and made the supplement available for public review and
comment from June 28, 2021, through August 5, 2021. Missouri did not
receive any public comments on the maintenance plan supplement.
    In addition, as explained in the EPA's proposed rule (and in more
detail in the technical support document which is included in the
docket for this action), the revision meets the substantive SIP
requirements of the CAA, including section 110 and implementing
regulations.

III. What are the actions the EPA is taking?

    The EPA is taking final action to approve the maintenance plan for
the Jackson County 2010 SO2 1-hour NAAQS nonattainment area
into the Missouri SIP (as compliant with CAA section 175A). The
maintenance plan demonstrates that the area will continue to maintain
the 2010 1-hour SO2 NAAQS and includes a process to develop
contingency measures to remedy any future violations of the 2010 1-hour
SO2 NAAQS and procedures for evaluation of potential
violations.
    Additionally, the EPA is taking final action to determine that the
Jackson County 2010 SO2 1-hour NAAQS nonattainment area has
met the criteria under CAA section 107(d)(3)(E) for redesignation from
nonattainment to attainment for the 2010 1-hour SO2 NAAQS.
On this basis, the EPA is approving Missouri's redesignation request
for the area and changing the legal designation of the portion of
Jackson County designated nonattainment at 40 CFR part 81 to attainment
for the 2010 1-hour SO2 NAAQS.

IV. Environmental Justice Concerns

    When the EPA establishes a new or revised NAAQS, the CAA requires
the EPA to designate all areas of the U.S. as either nonattainment,
attainment, or unclassifiable. Area designations address environmental
justice concerns by ensuring that the public is properly informed about
the air quality in an area. If an area is designated nonattainment of
the NAAQS, the CAA provides for the EPA to redesignate the area to
attainment upon a demonstration by the state authority that air quality
is attaining the NAAQS and will continue to maintain the NAAQS in order
to ensure that all those residing, working, attending school, or
otherwise present in those areas are protected, regardless of minority
and economic status.
    The EPA utilized the EJSCREEN tool to evaluate environmental and
demographic indicators within the area. The tool outputs are contained
in the docket for this action. The demographic indicators from EPA's
EJSCREEN tool demonstrate that there are vulnerable populations in the
area, including people of color, low-income populations, linguistically
isolated populations, and populations with less than high school-level
education.
    This action addresses a redesignation determination for the Jackson
County, Missouri, area. Under CAA section 107(d)(3), the redesignation
of an area to attainment/unclassifiable is an action that affects the
status of a geographical area and does not impose any additional
regulatory requirements on sources beyond those imposed by state law.
As discussed in this document and the

associated technical support document, Missouri has demonstrated that
the air quality in the Jackson County area is attaining the NAAQS and
will continue to maintain the NAAQS. For these reasons, this action
does not result in disproportionately high and adverse human health or
environmental effects on minority populations, low-income populations
and/or indigenous peoples.

V. Incorporation by Reference

    In this document, the EPA is amending regulatory text that includes
incorporation by reference. In accordance with the requirements of 1
CFR 51.5, the EPA is finalizing the incorporation by reference of the
Missouri State Implementation Plan described in the amendments to 40
CFR part 52 set forth below. The EPA has made, and will continue to
make, these materials generally available through www.regulations.gov
and at the EPA Region 7 Office (please contact the person identified in
the FOR FURTHER INFORMATION CONTACT section of this document for more
information).

VI. Statutory and Executive Order Reviews

    Under the Clean Air Act (CAA), the Administrator is required to
approve a SIP submission that complies with the provisions of the Act
and applicable Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a).
Thus, in reviewing SIP submissions, the EPA's role is to approve State
choices, if 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 Orders 12866 (58
FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011);
     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 an economically significant regulatory action based
on health or safety risks subject to Executive Order 13045 (62 FR
19885, April 23, 1997);
     Is not a significant regulatory action subject to
Executive Order 13211 (66 FR 28355, May 22, 2001);
     Is not subject to requirements of the National Technology
Transfer and Advancement Act (NTTA) because this rulemaking does not
involve technical standards; and
     This action does not have disproportionately high and
adverse human health or environmental effects on minority populations,
low-income populations and/or indigenous peoples, as specified in
Executive Order 12898 (59 FR 7629, February 16, 1994). The basis for
this determination is contained in Section IV of this action,
``Environmental Justice Concerns.''
    The SIP is not approved to apply on any Indian reservation land or
in any other area where the 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).
    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).
    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 April 1, 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 section 307(b)(2)).

List of Subjects

40 CFR Part 52

    Environmental protection, Air pollution control, Incorporation by
reference, Maintenance plan, Redesignation, Sulfur oxides.

40 CFR Part 81

    Environmental protection, Air pollution control, Designations,
Intergovernmental relations, Redesignation, Reporting and recordkeeping
requirements, Sulfur oxides.

    Dated: January 14, 2022.
Meghan A. McCollister,
Regional Administrator, Region 7.

    For the reasons stated in the preamble, EPA amends 40 CFR parts 52
and 81 as set forth below:

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 AA--Missouri

0
2. In Sec.  52.1320:
0
a. The table in paragraph (d) is amended by adding the entry ``(35)''
in numerical order.
0
b. The table in paragraph (e) is amended by adding the entry ``(82)''
in numerical order.
    The additions read as follows:

Sec.  52.1320  Identification of plan.

* * * * *
    (d) * * *

                            EPA-Approved Missouri Source-Specific Permits and Orders
----------------------------------------------------------------------------------------------------------------
                                                           State
          Name of source             Order/permit No.    effective    EPA approval date         Explanation
                                                            date
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
(35) Vicinity Energy--Kansas City  Consent Agreement      6/25/2021  1/31/2022 [insert
                                    No. APCP-2021-007.                Federal Register
                                                                      citation].
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    (e) * * *

                               EPA-Approved Missouri Nonregulatory SIP Provisions
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                                        Applicable          State
    Name of nonregulatory SIP          geographic or      submittal     EPA approval date        Explanation
             revision               nonattainment area       date
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                                                  * * * * * * *
(82) Jackson County 1-hour SO2     Jackson County......   2/18/2021;  1/31/2022, [insert    This action approves
 NAAQS Maintenance Plan and                                 9/7/2021   Federal Register      the Maintenance
 Maintenance Plan Supplement.                                          citation].            Plan and the
                                                                                Maintenance Plan
                                                                                Supplement for the
                                                                                Jackson County
                                                                                area.
----------------------------------------------------------------------------------------------------------------

0
3. In Sec.  52.1343, add paragraph (d) to read as follows:

Sec.  52.1343  Control strategy: Sulfur dioxide.

* * * * *
    (d) Redesignation to attainment. As of March 2, 2022, the Jackson
County 2010 SO2 nonattainment area is redesignated to
attainment of the 2010 SO2 1-hour National Ambient Air
Quality Standard (NAAQS) in accordance with the requirements of Clean
Air Act (CAA) section 107(d)(3) and EPA has approved its maintenance
plan and maintenance plan supplement as meeting the requirements of CAA
section 175A.

PART 81--DESIGNATION OF AREAS FOR AIR QUALITY PLANNING PURPOSES

0
4. The authority citation for part 81 continues to read as follows:

    Authority:  42 U.S.C. 7401, et seq.

Subpart C--Section 107 Attainment Status Designations

0
5. In Sec.  81.326, revise the entry ``Jackson County, MO'' in the
table entitled ``Missouri--2010 Sulfur Dioxide NAAQS [Primary]'' to
read as follows:

Sec.  81.326  Missouri.

* * * * *

                   Missouri--2010 Sulfur Dioxide NAAQS
                                [Primary]
------------------------------------------------------------------------
                                                Designation
       Designated area \1\       ---------------------------------------
                                     Date \2\              Type
------------------------------------------------------------------------
Jackson County, MO..............        3/2/2022  Attainment.
Jackson County (part).
The portion of Jackson County
 bounded by I-70/I-670 and the
 Missouri River to the north;
 and, to the west of I-435 to
 the state line separating
 Missouri and Kansas.

                              * * * * * * *
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\1\Includes any Indian country in each county or area, unless otherwise
  specified. EPA is not determining the boundaries of any area of Indian
  country in this table, including any area of Indian country located in
  the larger designation area. The inclusion of any Indian country in
  the designation area is not a determination that the state has
  regulatory authority under the Clean Air Act for such Indian country.
\2\ This date is April 9, 2018, unless otherwise noted.

* * * * *
[FR Doc. 2022-01649 Filed 1-28-22; 8:45 am]
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[Federal Register Volume 88, Number 13 (Friday, January 20, 2023)]
[Notices]
[Pages 3743-3744]
[FR Doc No: 2023-01031]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2022-D-2899]

Effectiveness of Anthelmintics: Specific Recommendations for
Products Proposed for the Prevention of Heartworm Disease in Dogs;
Draft Guidance for Industry; Availability; Extension of Comment Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability; extension of comment period.

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SUMMARY: The Food and Drug Administration (FDA or the Agency) is
extending the comment period for the notice announcing the availability
of a

draft guidance for industry that appeared in the Federal Register of
November 30, 2022. In that notice, FDA requested comments on draft
guidance for industry (GFI) #276 entitled ``Effectiveness of
Anthelmintics: Specific Recommendations for Products Proposed for the
Prevention of Heartworm Disease in Dogs.'' The Agency is taking this
action in response to a request for an extension to allow interested
persons additional time to submit comments.

DATES: FDA is extending the comment period on the notice published
November 30, 2022 (87 FR 73560). Submit either electronic or written
comments by May 1, 2023, to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final
version of the guidance.

ADDRESSES: You may submit comments on any guidance at any time as
follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2022-D-2899 for ``Effectiveness of Anthelmintics: Specific
Recommendations for Products Proposed for the Prevention of Heartworm
Disease in Dogs.'' Received comments will be placed in the docket and,
except for those submitted as ``Confidential Submissions,'' publicly
viewable at https://www.regulations.gov or at the Dockets Management
Staff between 9 a.m. and 4 p.m., Monday through Friday,<PHONE_NUMBER>.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Steven Fleischer, Center for
Veterinary Medicine (HFV-110), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855,<PHONE_NUMBER>,
[email protected].

SUPPLEMENTARY INFORMATION: In the Federal Register of November 30,
2022, FDA published a notice announcing the availability of a draft
guidance for industry entitled ``Effectiveness of Anthelmintics:
Specific Recommendations for Products Proposed for the Prevention of
Heartworm Disease in Dogs,'' and requesting comments on the proposed
GFI.
    Interested persons were originally given until January 30, 2023, to
comment on the document. The Agency has received a request for an
extension of the comment period. The request stated that an additional
90 days would allow interested parties to thoroughly consider the
request for input. FDA has considered the request and is extending the
comment period for the request for comments for 90 days, until May 1,
2023. The Agency believes that a 90-day extension allows adequate time
for interested persons to submit comments.

    Dated: January 17, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-01031 Filed 1-19-23; 8:45 am]
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