[Federal Register Volume 83, Number 191 (Tuesday, October 2, 2018)]
[Notices]
[Page 49569]
[FR Doc No: 2018-21391]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-4383-DR; Docket ID FEMA-2018-0001]

Wisconsin; Amendment No. 1 to Notice of a Major Disaster
Declaration

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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SUMMARY: This notice amends the notice of a major disaster declaration
for the State of Wisconsin (FEMA-4383-DR), dated August 10, 2018, and
related determinations.

DATES: The change occurred on September 7, 2018.

FOR FURTHER INFORMATION CONTACT: Dean Webster, Office of Response and
Recovery, Federal Emergency Management Agency, 500 C Street SW,
Washington, DC 20472,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The Federal Emergency Management Agency
(FEMA) hereby gives notice that pursuant to the authority vested in the
Administrator, under Executive Order 12148, as amended, Steven W.
Johnson, of FEMA is appointed to act as the Federal Coordinating
Officer for this disaster.
    This action terminates the appointment of David G. Samaniego as
Federal Coordinating Officer for this disaster.

    The following Catalog of Federal Domestic Assistance Numbers
(CFDA) are to be used for reporting and drawing funds: 97.030,
Community Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis
Counseling; 97.033, Disaster Legal Services; 97.034, Disaster
Unemployment Assistance (DUA); 97.046, Fire Management Assistance
Grant; 97.048, Disaster Housing Assistance to Individuals and
Households In Presidentially Declared Disaster Areas; 97.049,
Presidentially Declared Disaster Assistance--Disaster Housing
Operations for Individuals and Households; 97.050, Presidentially
Declared Disaster Assistance to Individuals and Households--Other
Needs; 97.036, Disaster Grants--Public Assistance (Presidentially
Declared Disasters); 97.039, Hazard Mitigation Grant.

Brock Long,
Administrator, Federal Emergency Management Agency.
[FR Doc. 2018-21391 Filed 10-1-18; 8:45 am]
 BILLING CODE 9111-11-P


[Federal Register Volume 84, Number 28 (Monday, February 11, 2019)]
[Rules and Regulations]
[Pages 3108-3112]
[FR Doc No: 2019-00718]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 60, 61, 63, and 70

[EPA-R08-OAR-2018-0299; FRL-9988-39--Region 8]

Approval of Recodification and Revisions to State Air Pollution
Control Rules; North Dakota; Interim Approval of Title V Program
Recodification and Revisions; Approval of Recodification and Revisions
to State Programs and Delegation of Authority To Implement and Enforce
Clean Air Act Sections 111 and 112 Standards and Requirements

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: The Environmental Protection Agency (EPA or the ``Agency'') is
finalizing interim approval of revisions to the North Dakota operating
permit program for stationary sources subject to title V of the Clean
Air Act (CAA or the ``Act'') and recodification of the State's title V
program under a new title of the North Dakota Administrative Code
(NDAC). The EPA is also approving North Dakota's revision and
recodification of North Dakota's programs for implementing and
enforcing delegated requirements under CAA sections 111 and 112, and
for carrying out a State Acid Rain Program under sections 401-406 of
the Act as a portion of the operating permits program.

DATES: This rule is effective on March 15, 2019.

ADDRESSES: The EPA has established a docket for this action under
Docket ID No. EPA-R08-OAR-2018-0299. All documents in the docket are
listed on the http://www.regulations.gov website. Although listed in
the index, some information is not publicly available, e.g., 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 http://www.regulations.gov, or please contact the person identified in the FOR
FURTHER INFORMATION CONTACT section for additional availability
information.

FOR FURTHER INFORMATION CONTACT: Gregory Lohrke, Air Program, EPA,
Region 8, Mailcode 8P-AR, 1595 Wynkoop Street, Denver, Colorado 80202-
1129,<PHONE_NUMBER><EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Throughout this document ``we,'' ``us,'' and
``our'' means the EPA.
    This action also informs the public that on December 17, 2018, the
EPA authorized delegation to implement and enforce CAA section 111 New
Source Performance Standards (NSPS) \1\ and section 112 National
Emission Standards for Hazardous Air Pollutants (NESHAP), including
Maximum Achievable Control Technology (MACT) \2\ requirements within
the State, excluding Indian country, exactly as the requirements were
promulgated by the EPA (i.e., ``straight delegation''). In authorizing
the delegation of these authorities, the EPA's letters also grant North
Dakota eligibility for future ``automatic delegation'' of incorporated,
unchanged federal requirements, without the need to request Agency
approval, on a case-by-case basis. These approvals effect the transfer
of North Dakota's title V program administration, including
administration of the state acid rain program, and delegated authority
to implement and enforce CAA sections 111 and 112 requirements from the
North Dakota Department of Health (NDDH) to the newly created North
Dakota Department of Environmental Quality (NDDEQ or the
``Department''). The EPA is finalizing these actions in accordance with
sections 501-506, 111, 112, 401-416 of the Act.
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    \1\ Monica Morales, Director, EPA Region 8 Air Program to Terry
O'Clair, Director, Division of Air Quality, North Dakota Department
of Health. ``Automatic Delegation of Clean Air Act Section 111
Authorities and Responsibilities'' December 17, 2018.
    \2\ Monica Morales, Director, EPA Region 8 Air Program to Terry
O'Clair, Director, Division of Air Quality, North Dakota Department
of Health. ``Automatic Delegation of Clean Air Act Section 112
Responsibilities'' December 17, 2018.
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I. Background

    The background for this action is discussed in detail in our
October 30, 2018 notice of proposed rulemaking (83 FR 54532). In that
document we proposed to approve recodification and revisions to the
North Dakota title V operating permits program on an interim basis.\3\
The proposed interim

approval of North Dakota's operating permit program included, as a
portion, acceptance of the State's recodification of regulations
enabling the implementation of a State acid rain program under title IV
of the Act. In that same notice, we also proposed approval of North
Dakota's revised and recodified programs for the implementation and
enforcement of CAA section 111 and 112 standards and further proposed a
straight delegation of authority to the State of North Dakota to
administer certain standards under sections 111 (NSPS requirements) and
112 (NESHAP requirements) as they are incorporated unchanged from the
Code of Federal Regulations (CFR) into the State's administrative code.
The notice of proposed rulemaking offered the public the opportunity to
comment on these proposed program approvals and delegations of
authority and the transfer of program authorities to NDDEQ.
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    \3\ For reference here and throughout today's notice concerning
the renumbering and recodification of NDCC and NDAC provisions
relevant to the transfer of CAA authorities to the NDDEQ, see the
document, ``Crosswalk on Recodifications of Relevant NDCC and NDAC
Sections,'' available in the docket for today's notice. For purposes
of cross-referencing a recodified provision of the NDAC air
pollution control rules with its previous version, we note that the
recodification followed a consistent scheme: All rules previously
codified as 33-15-xx-xx are now codified as 33.1-15-xx-xx. For
example: All Title V Permit to Operate provisions previously
codified under NDAC section 33-15-14-06 are now codified at
corresponding subsections of NDAC section 33.1-15-14-06.
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    We received no comments on our proposed rulemaking action;
therefore, we are finalizing all rulemaking actions, including
previously unapproved amendments to North Dakota's title V rules as
they were described in our proposed rulemaking document.\4\
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    \4\ Our final approval includes previously unapproved amendments
to North Dakota's title V permit program rules, as discussed in our
proposal, 83 FR 54535; See also docket item, ``Post 1999 Amendments
to ND Title V Program,'' for details of the amendments the EPA is
approving with this action.
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II. Final Action

A. Interim Approval of the North Dakota Title V Program

    The EPA is granting interim approval of the North Dakota operating
permit program under 40 CFR 70.4(d) and CAA section 502(g).
Additionally, as the State implements a title IV acid rain program
through issuance and enforcement of title V operating permits, the EPA
is also granting final approval of the transfer and recodification of
North Dakota's acid rain program from the NDDH to the NDDEQ.\5\ The EPA
is granting interim approval of the operating permit program as the
program is revised and recodified in NDAC article 33.1-15 and as it had
been submitted by the State, reviewed and proposed for approval in our
previous rulemaking document.\6\ The EPA is granting interim approval
because, although North Dakota's operating permit program meets minimum
title V requirements and otherwise meets 40 CFR part 70 requirements
for an operating permit program, as explained in the Attorney General's
Opinion,\7\ the State's rules do not provide the full legal authority
necessary for judicial review. This issue was explained in detail in
our proposed rulemaking document and must be remedied before the EPA
may grant final full approval of North Dakota's revised and recodified
title V program (40 CFR 70.4(e)(3)). Specifically, the State's
forthcoming rules must provide that if the final permit action being
challenged is the Department's failure to take final action, a petition
for judicial review may be filed at any time before the Department
denies the permit or issues the final permit; and that where petitions
for judicial review are based solely on grounds arising after the 30-
day deadline for judicial review, such petitions may be filed no later
than 30 days after the new grounds for review arise. Upon notice of
remedy of this issue from the State, receipt of effective State rules
and an amended Attorney General's Opinion certifying complete legal
authority to grant judicial review as required by 40 CFR 70.4(b)(3)(x)-
(xii), the EPA intends to propose full approval of North Dakota's
operating permit program. Interim program approval will expire on March
19, 2020 and the State is required to ``submit to the EPA changes to
the program addressing the deficiencies specified in the interim
approval no later than 6 months prior to the expiration of the interim
approval.'' \8\
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    \5\ The State's Acid Rain rules (NDAC 33.1-15-21) with an
effective date of January 1, 2019, were submitted via email from Tom
Bachman, North Dakota Department of Health, to Gregory Lohrke, EPA
Region 8 Air Program on December 10, 2018.
    \6\ 83 FR 54534-54537; Our approval also considers the following
supplemental documents submitted by the State of North Dakota after
our proposal: ``Addendum to August 16, 2018 Attorney General's
Opinion Operating Permits Program.'' December 12, 2018; ``Supplement
to the Attorney General Statements Relating to Programs Being
Transferred to the North Dakota Department of Environmental
Quality.'' October 23, 2018; and NDAC 33.1-15-14-06, ``Title V
Permit to Operate,'' and 33.1-15-23-04, ``Major Source Permit to
Operate Fees.'' Both effective on January 1, 2019. Submitted via
electronic correspondence by Tom Bachman, North Dakota Department of
Health to Gregory Lohrke, EPA Region 8 Air Program. December 10,
2018.
    \7\ ``Attorney General's Opinion Operating Permits Program.''
August 16, 2018.
    \8\ 40 CFR 70.4(f)(1).
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    For further details and background regarding the interim approval
of North Dakota's revised operating permits program and the transfer of
state operating permits program implementation and enforcement
authority to the NDDEQ, please reference the proposed rulemaking
document associated with this action.\9\
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    \9\ 83 FR 54534-54537.
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B. NSPS Program Approval and Delegations

    The EPA has determined that the revisions to the North Dakota CAA
section 111 program are adequate and effective for implementation and
enforcement of NSPS requirements and is approving the recodification of
the State's program and incorporated federal NSPS requirements under a
new title and chapter of the NDAC.\10\ On December 17, 2018, the EPA
provided notice to North Dakota of approval of both a straight
delegation of authority to implement and enforce all federal NSPS
requirements incorporated unchanged into state regulations, and
approval of automatic delegation of authority to implement and enforce
federal NSPS requirements incorporated unchanged at a future date
without need for case-by-case approvals. This notice of approval in the
Federal Register finalizes the EPA's determination that the North
Dakota section 111 program as it is to be administered by the NDDEQ is
adequate for the delegated implementation and enforcement of federal
NSPS requirements incorporated unchanged into NDAC 33.1-15-12 before
this rulemaking action, as well as adequate for the prospective,
automatic delegation of federal NSPS requirements incorporated
unchanged into that NDAC chapter in the future.
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    \10\ NDAC chapter 33.1-15-12, Standards of Performance for New
Stationary Sources; and related fee provisions NDAC Sec. Sec.  33.1-
15-23-01, 33.1-15-23-02, 33.1-15-23-03, effective January 1, 2019.
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    The EPA's delegation letter and other supporting materials for
today's action may be found in the docket for this final rule at http://www.regulations.gov. A current summary of NSPS delegations to North
Dakota is posted under the ``Delegations of Authority'' link at http://www.epa.gov/region8/air-program. Further delegation updates will be
provided through this web page on a quarterly basis to notify the
public of the current NSPS delegation status to the State.

C. NESHAP Program Approval and Delegations

    The EPA has determined that the revisions to the North Dakota
section 112 program are adequate and effective for implementation and
enforcement of NESHAP requirements and is approving the recodification
of the State's program and incorporated federal NESHAP requirements
under a new title and chapter of the NDAC.\11\ On December

17, 2018, the EPA provided notice to North Dakota of approval of both a
straight delegation of authority to implement and enforce all federal
NESHAP requirements incorporated unchanged into state regulations, and
approval of automatic delegation of authority to implement and enforce
federal NESHAP requirements incorporated unchanged at a future date
without need for case-by-case approvals. This notice of approval in the
Federal Register finalizes the EPA's determination that the North
Dakota section 112 program as it is to be administered by the NDDEQ is
adequate for the delegated implementation and enforcement of federal
NESHAP requirements incorporated unchanged into NDAC chapters 33.1-15-
13 and 33.1-15-22 before this rulemaking action, as well as adequate
for the receipt of prospective, automatic delegation of federal NESHAP
requirements incorporated unchanged into NDAC chapters 33.1-15-13 and
33.1-15-22 in the future.
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    \11\ NDAC chapters 33.1-15-13, National Emission Standards for
Hazardous Air Pollutants and 33.1-15-22, National Emission Standards
for Hazardous Air Pollutants for Source Categories; effective
January 1, 2019; and related fee provisions NDAC Sec. Sec.  33.1-15-
23-01, 33.1-15-23-02, 33.1-15-23-03, effective January 1, 2019.
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    The EPA's delegation letter and other supporting materials for
today's action may be found in the docket for this final rule at http://www.regulations.gov. A current summary of NESHAP delegations to North
Dakota is posted under the ``Delegations of Authority'' link at http://www.epa.gov/region8/air-program. Further delegation updates will be
provided through this web page on a quarterly basis to notify the
public of current NESHAP delegation status to the State.

D. Effective Date of Program Approvals and Delegations of Authority

    Based on our conversations with the State, we determined a specific
date for when the NDDEQ rules and agency become fully effective under
federal law. All revisions to the State's title V operating permit
program, section 111 and 112 programs and the State acid rain program
would be federally enforceable as of the effective date of EPA's
approval of the respective revision on March 15, 2019, and
codifications of those regulations, with the exception of the EPA's
grant of interim approval to the operating permits program. The EPA's
understanding is that the State plans to rely on the date when the EPA
signs the final notice for purposes of notifying the State legislature
that the EPA has approved these revisions, which will provide for the
transfer of authority from NDDH to NDDEQ to be effective under State
law. The EPA also understands that there are some programs that will
not be required to be a part of this approval. Thus, prior to the
effective date of this approval, the EPA understands that the State
intends to take the necessary additional steps as specified in S.L.
2017, ch. 199, Section 1, to ensure that NDDEQ rules and the NDDEQ
would become federally enforceable on the effective date of the EPA's
approval and codification of the operating permit, NSPS, MACT/NESHAP
and acid rain programs. Unless and until the NDDEQ rules and agency
become fully effective under federal law, for purposes of federal law
the EPA recognizes the State's program as currently approved under the
North Dakota Department of Health.\12\
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    \12\ As explained in this rulemaking action's corresponding
proposed rule, the EPA's interim approval of North Dakota's transfer
of its Title V Program and State Acid Rain Program and the Agency's
delegation to North Dakota of authority for NESHAP, MACT and NSPS
from the Department of Health to the Department of Environmental
Quality does not extend to Indian country as defined in 18 U.S.C.
1151. Indian country generally includes (1) lands within the
exterior boundaries of the following Indian reservations located
within North Dakota: The Fort Berthold Indian Reservation, the
Spirit Lake Reservation, the Standing Rock Sioux Reservation, and
the Turtle Mountain Reservation; (2) any land held in trust by the
United States for an Indian tribe; and (3) any other areas that are
``Indian country'' within the meaning of 18 U.S.C. 1151. The EPA, or
eligible Indian tribes, as appropriate, will retain responsibilities
under CAA Sections 501-506, 111, 112, 401-416 for air quality in
Indian country. This footnote and our final notice include the Acid
Rain program and respective CAA Sections, which were referenced
elsewhere in the proposal and inadvertently not included in footnote
4 in our proposal (83 FR 54533-54534).
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III. Statutory and Executive Order Reviews

    Under the CAA, the Administrator is required to approve:

     A state permit program submittal that complies with the
provisions of the Act and applicable federal regulations. 42 U.S.C.
7661a(d); 40 CFR 70.1(c), 70.4(i). Thus, in reviewing permit program
submittals, the EPA's role is to approve state choices, provided
they meet the criteria of the CAA and the criteria, standards and
procedures defined in 40 CFR part 70;
     A state acid rain program as a component of the state
operating permit program submittal that complies with the provisions
of the Act and applicable federal regulations. 42 U.S.C. 7651g(a),
7661e(b); 40 CFR part 72, subpart G. Thus, in reviewing state acid
rain program submittals, the EPA's role is to approve state choices,
provided they meet, and do not alter, the criteria of the CAA and
implement the requirements, standards and procedures defined in 40
CFR parts 70 and 72-78;
     A state program for receiving delegated authority to
implement and enforce emission limitations for new stationary
sources subject to section 111 if such program complies with the
provisions of the Act and applicable federal regulations. 42 U.S.C.
7411(c). Thus, in reviewing section 111 program submittals, the
EPA's role is to approve state choices, provided they meet the
criteria of the CAA and implement the requirements, standards and
procedures defined in 40 CFR part 60; and
     A state program for receiving delegated authority to
implement and enforce emission standards and other requirements for
air pollutants subject to section 112 if such program complies with
the provisions of the Act and applicable federal regulations. 42
U.S.C. 7412(l); 40 CFR part 63, subpart E. Thus, in reviewing
section 112 program submittals, the EPA's role is to approve state
choices, provided they meet the criteria of the CAA and the
criteria, standards and procedures defined in 40 CFR parts 61 and
63.

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);
     Is not an Executive Order 13771 (82 FR 9339, February
2, 2017) regulatory action because Operating Permits Program
approvals are exempted 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 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 section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (15 U.S.C.
272 note) because application of those requirements would be
inconsistent with the CAA; and
     Does not provide EPA with the discretionary authority
to address, as appropriate, disproportionate human health or
environmental effects, using practicable and legally permissible
methods, under Executive Order 12898 (59 FR 7629, February 16,
1994).

This action does not 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).
    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. The 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 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 April 12, 2019. 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 60

    Environmental protection, Air pollution control, Incorporation by
reference, Intergovernmental relations, New source performance
standards, Delegation of authority.

40 CFR Part 61

    Environmental protection, Air pollution control, Incorporation by
reference, Intergovernmental relations, National emission standards for
hazardous air pollutants, Delegation of authority.

40 CFR Part 63

    Environmental protection, Air pollution control, Incorporation by
reference, Intergovernmental relations, National emission standards for
hazardous air pollutants, Maximum achievable control technology,
Delegation of authority.

40 CFR Part 70

    Environmental protection, Air pollution control, Intergovernmental
relations, Operating permit program, State acid rain program, Title V.

    Dated: December 20, 2018.
Douglas Benevento,
Regional Administrator, Region 8.

    Title 40 of the CFR is amended as follows:

PART 60--STANDARDS OF PERFORMANCE FOR NEW STATIONARY SOURCES

0
1. The authority citation for part 60 continues to read as follows:

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

Subpart A--General Provisions

0
2. Section 60.4 is amended by revising paragraph (b)(36) to read as
follows:

Sec.  60.4  Address.

* * * * *
    (b) * * *
    (36) State of North Dakota, North Dakota Department of
Environmental Quality, 918 East Divide Avenue, Bismarck, ND 58501-1947.

    Note: For a table listing Region VIII's NSPS delegation status,
see paragraph (c) of this section.

* * * * *

PART 61--NATIONAL EMISSION STANDARDS FOR HAZARDOUS AIR POLLUTANTS

0
3. The authority citation for part 61 continues to read as follows:

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

Subpart A--General Provisions

0
4. Section 61.04 is amended by revising paragraphs (b)(36) and (c)(8)
to read as follows:

Sec.  61.04  Address.

* * * * *
    (b) * * *
    (36) State of North Dakota, North Dakota Department of
Environmental Quality, 918 East Divide Avenue, Bismarck, ND 58501-1947.

    Note: For a table listing Region VIII's NESHAP delegation
status, see paragraph (c) of this section.

* * * * *
    (c) * * *
    (8) The most current delegation status table for National Emissions
Standards for Hazardous Air Pollutants for Region VIII can be found
online at http://www.epa.gov/region8/air-program. The following is a
table indicating the delegation status of National Emissions Standards
for Hazardous Air Pollutants in Region VIII. The recodification and
delegation for North Dakota's August 6, 2018 submittal is effective as
of March 15, 2019, as detailed in EPA's delegation letter of December
17, 2018.

         Region VIII--Delegation Status of National Emissions Standards for Hazardous Air Pollutants \1\
----------------------------------------------------------------------------------------------------------------
              Subpart                    CO           MT           ND           SD         UT \2\         WY
----------------------------------------------------------------------------------------------------------------
A General Provisions..............  *            *            *            *            *            ...........
B Radon Emissions from Underground  ...........  ...........  ...........  ...........  *            ...........
 Uranium Mines.
C Beryllium.......................  *            *            ...........  ...........  *            ...........
D Beryllium Rocket Motor Firing...  *            *            ...........  ...........  *            ...........
E Mercury.........................  *            *            ...........  ...........  *            ...........
F Vinyl Chloride..................  *            *            ...........  ...........  *            ...........
H Emissions of Radionuclides other  ...........  ...........  ...........  ...........  ...........  ...........
 than Radon from Department of
 Energy Facilities.
I Radionuclide Emissions from       ...........  ...........  ...........  ...........  ...........  ...........
 Facilities Licensed by the
 Nuclear Regulatory Commission and
 Federal Facilities not covered by
 Subpart H.
J Equipment Leaks (Fugitive         *            *            *            ...........  *            ...........
 Emission Sources) of Benzene.
K Radionuclide Emissions from       ...........  ...........  ...........  ...........  ...........  ...........
 Elemental Phosphorus Plants.
L Benzene Emissions from Coke By-   ...........  *            ...........  ...........  *            ...........
 Product Recovery Plants.
M Asbestos........................  *            *            *            *            *            * \3\
N Inorganic Arsenic Emissions from  ...........  *            ...........  ...........  *            ...........
 Glass Manufacturing Plants.

O Inorganic Arsenic Emissions from  ...........  *            ...........  ...........  *            ...........
 Primary Copper Smelters.
P Inorganic Arsenic Emissions from  ...........  *            ...........  ...........  *            ...........
 Arsenic Trioxide and Metallic
 Arsenic Production Facilities.
Q Radon Emissions from Department   ...........  ...........  ...........  ...........  *            ...........
 of Energy Facilities.
R Radon Emission from               ...........  ...........  ...........  ...........  *            ...........
 Phosphogypsum Stacks.
T Radon Emissions from the          ...........  ...........  ...........  ...........  *            ...........
 Disposal of Uranium Mill Tailings.
V Equipment Leaks (Fugitive         ...........  *            *            ...........  *            ...........
 Emission Sources).
W Radon Emissions from Operating    ...........  ...........  ...........  ...........  *            ...........
 Mill Tailings.
Y Benzene Emissions from Benzene    ...........  *            ...........  ...........  *            ...........
 Storage Vessels.
BB Benzene Waste Operations.......  ...........  *            ...........  ...........  *            ...........
FF Benzene Waste Operations.......  ...........  *            *            ...........  *            ...........
----------------------------------------------------------------------------------------------------------------
*Indicates approval of delegation of subpart to state.
\1\ Specific authorities which may not be delegated include, but are not limited to Sec.  Sec.   61.04(b) and
  (c), 61.05(c), 61.11, 61.12(d), 61.13(h)(1)(ii), 61.14(d), 61.14(g)(1)(ii), 61.16, 61.112(c), 61.164(a)(2) and
  (3), 61.172(b)(2)(ii)(B) and (C), 61.174(a)(2) and (3), 61.242-1(c)(2), 61.244, and all authorities listed as
  not delegable in each individual subpart delegated to the state.
\2\ Indicates approval of National Emissions Standards for Hazardous Air Pollutants as part of the State
  Implementation Plan (SIP) with the exception of the radionuclide NESHAP subparts B, Q, R, T and W which were
  approved through section 112(l) of the Clean Air Act.
\3\ Delegation only for asbestos demolition, renovation, spraying, manufacturing, and fabricating operations,
  insulating materials, waste disposal for demolition, renovation, spraying, manufacturing and fabricating
  operations, inactive waste disposal sites for manufacturing and fabricating operations, and operations that
  convert asbestos-containing waste material into nonasbestos (asbestos-free) material.

* * * * *

PART 63--NATIONAL EMISSION STANDARDS FOR HAZARDOUS AIR POLLUTANTS
FOR SOURCE CATEGORIES

0
5. The authority citation for part 63 continues to read as follows:

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

Subpart E--Approval of State Programs and Delegation of Federal
Authorities

0
6. Section 63.99 is amended by revising paragraph (a)(35) to read as
follows:

Sec.  63.99  Delegated Federal authorities.

* * * * *
    (a) * * *
    (35) North Dakota. (i) The North Dakota Department of Agriculture
is delegated the authority to implement and enforce the provisions of
40 CFR part 68 at facilities with an anhydrous ammonia storage capacity
of ten thousand pounds or more that is intended to be used as
fertilizer or in the manufacturing of a fertilizer within North Dakota
and that are subject to the requirements of 40 CFR part 68, in
accordance with the final rule, dated December 30, 2013.
    (ii) The most current delegation status table for National Emission
Standards for Hazardous Air Pollutants for Source Categories in Region
VIII can be found online at http://www.epa.gov/region8/air-program.
* * * * *

PART 70--STATE OPERATING PERMIT PROGRAMS

0
7. The authority citation for part 70 continues to read as follows:

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

0
8. In appendix A to part 70, the entry for North Dakota is amended by
adding paragraph (d) to read as follows:

Appendix A to Part 70--Approval Status of State and Local Operating
Permits Programs

* * * * *
    North Dakota
* * * * *
    (d) The State of North Dakota submitted on August 6, 2018,
operating permit program revisions in a submittal package titled,
``Title V Permit to Operate MACT, NESHAPs and NSPS Programs for
Department of Environmental Quality Division of Air Quality.'' This
submittal package included a request from the North Dakota governor
to transfer authority to implement and enforce the operating permit
program from the North Dakota Department of Health to the North
Dakota Department of Environmental Quality. The recodified North
Dakota title V operating permits program is codified in N.D. Admin.
Code sections 33.1-15-14-06, 33.1-15-23-04, and 33.1-15-21. North
Dakota subsequently submitted on August 16, 2018 the, ``Attorney
General's Opinion Operating Permits Program,'' supplemented on
December 12, 2018, with an ``Addendum to August 16, 2018 Attorney
General's Opinion Operating Permits Program,'' stating that the laws
of the State provide adequate legal authority to carry out all
aspects of the program; interim approval effective on March 15,
2019; interim approval expires on March 19, 2020.
* * * * *
[FR Doc. 2019-00718 Filed 2-8-19; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register Volume 84, Number 36 (Friday, February 22, 2019)]
[Proposed Rules]
[Pages 5605-5608]
[FR Doc No: 2019-02634]

========================================================================
Proposed Rules
                                                Federal Register
________________________________________________________________________

This section of the FEDERAL REGISTER contains notices to the public of
the proposed issuance of rules and regulations. The purpose of these
notices is to give interested persons an opportunity to participate in
the rule making prior to the adoption of the final rules.

========================================================================

Federal Register / Vol. 84, No. 36 / Friday, February 22, 2019 /
Proposed Rules

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 21

[Docket No.: FAA-2018-1052; Notice No. 18-09]
RIN 2120-AL10

Foreign Civil Aviation Authority Certifying Statements

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

-----------------------------------------------------------------------

SUMMARY: The FAA proposes to revise a regulation that imposes a
duplicative requirement on foreign applicants for type certificates of
import products. Existing FAA regulations require all applicants to
submit two documents: A compliance listing to document the means of
compliance with applicable standards; and a corresponding statement of
compliance from the applicant certifying that all the requirements in
the certification basis have been complied with. These compliance
documents are duplicative and redundant to the certifying statement
that the FAA already requires from the foreign civil aviation authority
of the country or jurisdiction having State of Design responsibility
for the design approval holder of the product. The FAA proposes to no
longer require either the compliance listing or the accompanying
statement of compliance from the foreign applicant.

DATES: Send comments on or before April 23, 2019.

ADDRESSES: Send comments identified by docket number FAA-2018-1052
using any of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov and follow the online instructions for sending your
comments electronically.
     Mail: Send comments to Docket Operations, M-30; U.S.
Department of Transportation (DOT), 1200 New Jersey Avenue SE, Room
W12-140, West Building Ground Floor, Washington, DC 20590-0001.
     Hand Delivery or Courier: Take comments to Docket
Operations in Room W12-140 of the West Building Ground Floor at 1200
New Jersey Avenue SE, Washington, DC, between 9 a.m. and 5 p.m., Monday
through Friday, except Federal holidays.
     Fax: Fax comments to Docket Operations at<PHONE_NUMBER>.
    Privacy: The FAA will post all comments it receives, without
change, to http://www.regulations.gov, including any personal
information the commenter provides. Using the search function of the
docket website, anyone can find and read the electronic form of all
comments received into any FAA docket, including the name of the
individual sending the comment (or signing the comment for an
association, business, labor union, etc.). DOT's complete Privacy Act
Statement can be found in the Federal Register published on April 11,
2000 (65 FR 19477), as well as at http://DocketsInfo.dot.gov.
    Docket: Background documents or comments received may be read at
http://www.regulations.gov at any time. Follow the online instructions
for accessing the docket or go to the Docket Operations in Room W12-140
of the West Building Ground Floor at 1200 New Jersey Avenue SE,
Washington, DC, between 9 a.m. and 5 p.m., Monday through Friday,
except Federal holidays.

FOR FURTHER INFORMATION CONTACT: For questions concerning this action,
contact Steve Flanagan, Policy and Innovation Division Certification
Procedures Branch (AIR-6C0), Aircraft Certification Service, Federal
Aviation Administration, 800 Independence Ave. SW, Washington, DC
20027; telephone<PHONE_NUMBER>; email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Authority for This Rulemaking

    The FAA's authority to issue rules is found in Title 49 of the
United States Code. Subtitle I, Section 106 describes the authority of
the FAA Administrator. Subtitle VII, Aviation Programs, describes in
more detail the scope of the agency's authority.
    This rulemaking is promulgated under the authority described in
Subtitle VII, Part A, Subpart III, Section 44701. Under that section,
the FAA is charged with promoting safe flight of civil airplanes in air
commerce by prescribing minimum standards required in the interest of
safety for the design and performance of airplanes. The FAA also has
the authority to prescribe regulations for other practices, methods,
and procedures it finds necessary for safety in air commerce. This
rulemaking is within the scope of that authority because the proposed
rule would eliminate duplication and promote efficiency in the issuance
of type certificate approvals for import products certified by
bilateral partners of the FAA, while continuing to meet the FAA's
charge to promote safe flight.

I. Overview of the Proposal

    The FAA proposes to amend 14 CFR 21.20, ``Compliance with
applicable requirements,'' to exclude its applicability to import
products that have been type certificated outside of the United States
by a bilateral partner civil aviation authority (``CAA''). These
products are validated by the FAA consistent with the requirements in
14 CFR 21.29, ``Issue of type certificate: import products.'' This
proposed rule change would eliminate the necessity for redundant
compliance documents to the FAA by both the CAA and the foreign
applicant. The FAA would no longer require the foreign applicant to
submit either the means of compliance listing or the accompanying
statement of compliance because the FAA already requires that the
applicant provide technical data to show compliance and for the
bilateral partner CAA to provide a certifying statement of compliance.
In addition to streamlining the application process for import
products, this proposal would eliminate a burden to the FAA of
accepting and reviewing redundant and duplicative information. This
rule does not propose any changes to substantive type certification
requirements applicable to foreign applicants. bnm

II. Background

    The United States has bilateral aviation agreements with numerous
foreign countries for the acceptance of aeronautical products for
export and import. The FAA and the foreign civil aviation authority
(CAA) are responsible for implementing these agreements. Before making
an agreement, the FAA thoroughly reviews the certification and
production systems of the foreign

authority, including its organization, personnel, processes and
regulations. Approval of the bilateral agreement makes the foreign
authority (the CAA) a bilateral partner. The FAA does not sign an
agreement unless the FAA has confidence in the CAA's system for
certifying aviation products and overseeing the design organizations
and manufacturers under its authority. Under these bilateral
agreements, the CAA's type certification of a product is accepted by
the FAA for import through a ``validation'' process to ensure all
applicable requirements are met, including the procedural requirements
in Sec.  21.29, ``Issue of type certificate: import products.'' \1\
---------------------------------------------------------------------------

    \1\ For additional information on the validation process, see
FAA Order 8110.52B, Type Validation and Post-type Validation
Procedures, available online at https://www.faa.gov/regulations_policies/orders_notices/index.cfm/go/document.information/documentid/1031946.
---------------------------------------------------------------------------

    Section 21.29(a)(1) provides in pertinent part that the FAA may
issue a type certificate (``TC'') for an import product if the
applicable State of Design (i.e. the bilateral partner) ``certifies
that the product has been examined, tested, and found to meet,''
applicable requirements for aircraft noise, fuel venting, exhaust
emissions, and airworthiness. Therefore, in order for a product to
receive a validated TC from the FAA for import of the product, the
applicable foreign CAA must submit to the FAA a certifying statement
that the product complies with the requirements and standards which are
identified in the product's certification basis.
    In accordance with Sec.  21.29(a)(2), the FAA requires further that
the foreign applicant provide to the CAA technical data to show that
the product meets the applicable airworthiness and environmental
requirements. In practice, this requirement is accomplished when the
applicant submits to its CAA the technical data necessary for the CAA
to certificate the product. Through the typical terms of a bilateral
agreement, the FAA has access to this compliance data upon request to
the CAA.
    Section 21.20, ``Compliance with applicable requirements,'' was
issued in 2009 rule (74 FR 53385, October 16, 2009). That provision
requires an applicant for a type certificate, including an amended or
supplemental type certificate, to show and certify compliance with all
applicable requirements by submitting to the FAA two different
compliance documents: A compliance listing (Sec.  21.20(a)); and a
corresponding applicant statement of compliance \2\ (Sec.  21.20(b))
certifying the applicant complies with the applicable requirements in
its certification basis. In most cases, the Sec.  21.20(a) statement
takes the form of a compliance listing to document the means of
compliance, as described in Advisory Circular (AC) No. 21-51,
Applicant's Showing of Compliance and Certifying Statement of
Compliance (Sep. 28, 2011). At a minimum, the compliance listing
contains the following information: The design data; all the
requirements to be complied with; the means of compliance, whether by
analysis, test (flight, ground, or other), design similarity,
equivalent level of safety, or exemption, etc.; and a reference to the
substantiating data and documentation used to show compliance.
---------------------------------------------------------------------------

    \2\ The FAA has previously referred to the statement required
under Sec.  21.20(b) as the applicant ``certifying statement.''
However, in order to distinguish between the foreign CAA
``certifying statement'' under Sec.  21.29(a), the FAA now refers to
the Sec.  21.20(b) statement as the applicant ``statement of
compliance.''
---------------------------------------------------------------------------

    Section 21.20(b) establishes the FAA requirement for the TC
applicant's statement of compliance with applicable requirements, the
second of the two documents required by Sec.  21.20 from an applicant
for an FAA TC. An FAA TC applicant typically submits this statement of
compliance upon completion of its FAA TC program.\3\ Like the Sec.
21.29(a)(1) certifying statement from the foreign CAA, the Sec.
21.20(b) applicant statement of compliance contributes to product
safety and compliance by the FAA applicant's certification document
stating that the product being certified complies with minimum safety,
environmental, and other requirements identified in the product's FAA
certification basis.
---------------------------------------------------------------------------

    \3\ For additional information on type certification programs,
see FAA Order 8110.4C, Type Certification, available online at
https://www.faa.gov/regulations_policies/orders_notices/index.cfm/go/document.information/documentid/15172.
---------------------------------------------------------------------------

    As written, Sec.  21.20 requires compliance documents from all
applicants for type certificates, including foreign applicants seeking
validation by the FAA of the foreign CAA's TC of the import product
under Sec.  21.29. Section 21.20, therefore, requires foreign
applicants to generate and submit to the FAA the two applicant
compliance documents described above. These redundant and duplicative
data are in addition to the Sec.  21.29(a)(1) and (2) requirements
which request the same information.

III. Discussion of the Proposal

    The FAA proposes to eliminate the requirement on foreign applicants
of import products to submit the compliance listing and applicant
statement of compliance. Both of these documents are duplicative and
redundant of the foreign CAA certifying statement. The FAA is amending
Sec.  21.20 to specifically exclude its applicability to those
applicants seeking FAA validation TCs for import products under Sec.
21.29.
    The foreign CAA's certifying statement required in Sec.
21.29(a)(1) and the applicant's statement of compliance required in
Sec.  21.20(b) are substantively the same and duplicative. They both
provide certification that a product complies with the applicable
airworthiness, environmental, and other requirements in its
certification basis. Whether it is the foreign applicant or the CAA
that makes the statement is of no regulatory or legal significance.
Regardless of which person submits the statement, a fraudulent,
intentionally false, or misleading statement is a basis for denying
issuance of a type certificate and suspending or revoking an existing
type certificate. See 14 CFR 21.2, ``Falsification of applications,
reports, or records.'' Moreover, as stated above, the FAA enters into a
bilateral aviation agreement only if it has confidence in the foreign
CAA's certification system. This confidence extends to that CAA's
capability to certify that an import product has been examined, tested,
and found to meet applicable requirements. The additional statement of
compliance to the FAA by the foreign applicant is superfluous in light
of the bilateral partner's responsibilities.
    The compliance listing required under Sec.  21.20(a) is also
unnecessary for foreign applicants of type certificates of import
products. When a foreign applicant seeks type certification through the
validation process set forth in Sec.  21.29, it will have already
acquired, or is concurrently applying for, type certification through
its own CAA. As required by Sec.  21.29(a)(2), the foreign applicant
must have provided, or is concurrently providing, technical data to its
own CAA to show that the product meets all applicable airworthiness,
environmental, and other requirements documented in the certification
basis of the TC issued by the CAA. This information is available to the
FAA during validation if needed under the terms of the bilateral
agreement. Therefore, an additional compliance listing from the foreign
applicant is redundant in light of the requirements

in Sec.  21.29(a) and the CAA's work during its TC program.
    This proposed rule would eliminate the burden on foreign applicants
to produce and submit redundant documentation and would relieve the FAA
from the administrative burden associated with processing this
redundant paperwork. This proposal would apply to all type certificate
applications under Sec.  21.29, including product type, amended type,
supplemental, and amended supplemental type certificates. This proposal
would streamline the TC process for import products, thereby
facilitating U.S. industry access to aeronautical products.

IV. Regulatory Notices and Analyses

    Changes to Federal regulations must undergo several economic
analyses. First, Executive Orders 12866 and 13563 direct that each
Federal agency shall propose or adopt a regulation only upon a reasoned
determination that the benefits of the intended regulation justify its
costs. Second, the Regulatory Flexibility Act of 1980 (Pub. L. 96-354),
as codified in 5 U.S.C. 603 et seq., requires agencies to analyze the
economic impact of regulatory changes on small entities. Third, the
Trade Agreements Act of 1979 (Pub. L. 96-39), as amended, 19 U.S.C.
Chapter 13, prohibits agencies from setting standards that create
unnecessary obstacles to the foreign commerce of the United States. In
developing U.S. standards, the Trade Agreements Act requires agencies
to consider international standards and, where appropriate, that they
be the basis of U.S. standards. Fourth, the Unfunded Mandates Reform
Act of 1995 (Pub. L. 104-4), as codified in 2 U.S.C. 1532, requires
agencies to prepare a written assessment of the costs, benefits, and
other effects of proposed or final rules that include a Federal mandate
likely to result in the expenditure by State, local, or tribal
governments, in the aggregate, or by the private sector, of $100
million or more annually (adjusted for inflation with a base year of
1995). This portion of the preamble summarizes the FAA's analysis of
the economic impacts of this proposed rule.
    In conducting these analyses, the FAA has determined that this
proposal is not a ``significant regulatory action,'' as defined in
section 3(f) of Executive Order 12866. The rule is also not
``significant'' as defined in the Department of Transportation's
(DOT's) Regulatory Policies and Procedures. The proposed rule will not
have a significant economic impact on a substantial number of small
entities, will not create unnecessary obstacles to international trade,
and will not impose an unfunded mandate on State, local, or tribal
governments, or on the private sector.

A. Regulatory Evaluation

    DOT Order 2100.5 prescribes policies and procedures for
simplification, analysis, and review of regulations. If the expected
cost impact is so minimal that a proposed or final rule does not
warrant a full evaluation, this order permits a statement to that
effect and the basis for it to be included in the preamble if a full
regulatory evaluation of the costs and benefits is not prepared. Such a
determination has been made for this proposed rule. The reasoning for
this determination follows:
    By adding rule language which excludes the applicability of 14 CFR
21.20 ``Compliance with applicable requirements'' to products type
certificated outside of the United States by a bilateral partner, this
proposed rule will result in minor cost savings to the FAA.
    The FAA may issue a type certificate for a product that is type
certificated outside of the United States by a foreign CAA with which
the United States has a bilateral agreement. Validation of the CAA's TC
allows import of the product into the U.S. if the applicant and its CAA
complies with 14 CFR 21.29. These applicants have also been required to
comply with Sec.  21.20,\4\ which requires the applicant show
compliance with all applicable requirements and provide its statements
to the FAA showing and certifying compliance. Changing the rule to
exclude applications for type certificates of import products under
Sec.  21.29 from having to comply with Sec.  21.20 will have a small
reduction in burden on the FAA and on the manufacturer of such
products.
---------------------------------------------------------------------------

    \4\ While the current Sec.  21.20 does not specify whether the
applicants who must comply with that section are domestic, foreign,
or both, AC 21-51 indicates that foreign applicants need to comply
with 21.20 and make a statement directly to the FAA. AC 21-51 is
being revised, and will reflect this proposed rule change.
---------------------------------------------------------------------------

    These manufacturers will not have to submit documentation to the
FAA under Sec.  21.20, which is redundant to documentation provided by
the CAA to the FAA under Sec.  21.29. This will result in small cost
savings to the FAA, which will no longer have to accept and review the
documentation.

B. Regulatory Flexibility Determination

    The Regulatory Flexibility Act of 1980 (Pub. L. 96-354, ``RFA'')
establishes ``as a principle of regulatory issuance that agencies shall
endeavor, consistent with the objectives of the rule and of applicable
statutes, to fit regulatory and informational requirements to the scale
of the businesses, organizations, and governmental jurisdictions
subject to regulation. To achieve this principle, agencies are required
to solicit and consider flexible regulatory proposals and to explain
the rationale for their actions to assure that such proposals are given
serious consideration.'' The RFA covers a wide-range of small entities,
including small businesses, not-for-profit organizations, and small
governmental jurisdictions.
    Agencies must perform a review to determine whether a rule will
have a significant economic impact on a substantial number of small
entities. If the agency determines that it will, the agency must
prepare a regulatory flexibility analysis as described in the RFA.
    However, if an agency determines that a rule is not expected to
have a significant economic impact on a substantial number of small
entities, section 605(b) of the RFA provides that the head of the
agency may so certify and a regulatory flexibility analysis is not
required. The certification must include a statement providing the
factual basis for this determination, and the reasoning should be
clear.
    As discussed above, this proposed rule would result in minor cost
savings to foreign applicants and to the FAA. Because savings to
foreign entities are not relevant to this analysis and the FAA is not a
small entity there are no small entities affected and the impacts are
minor cost savings.
    Therefore, as provided in section 605(b), the head of the FAA
certifies that this rulemaking will not result in a significant
economic impact on a substantial number of small entities.

C. International Trade Impact Assessment

    The Trade Agreements Act of 1979 (Pub. L. 96-39), as amended,
prohibits Federal agencies from establishing standards or engaging in
related activities that create unnecessary obstacles to the foreign
commerce of the United States. Pursuant to this Act, the establishment
of standards is not considered an unnecessary obstacle to the foreign
commerce of the United States, so long as the standard has a legitimate
domestic objective, such as the protection of safety, and does not
operate in a manner that excludes imports that meet this objective. The
statute also requires consideration of international standards and,
where appropriate, that they be the basis for U.S. standards.

    The FAA has assessed the potential effect of this proposed rule and
has determined that the rule is in accord with the Trade Agreements Act
as to the rule expectations and responsibilities for domestic and
foreign persons engaged in aviation activities under 14 CFR.

D. Unfunded Mandates Assessment

    Title II of the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-
4) requires each Federal agency to prepare a written statement
assessing the effects of any Federal mandate in a proposed or final
agency rule that may result in an expenditure of $100 million or more
(in 1995 dollars) in any one year by State, local, and tribal
governments, in the aggregate, or by the private sector; such a mandate
is deemed to be a ``significant regulatory action.'' The FAA currently
uses an inflation-adjusted value of $155 million in lieu of $100
million.
    This proposed rule does not contain such a mandate; therefore, the
requirements of Title II of the Act do not apply.

E. Paperwork Reduction Act

    The Paperwork Reduction Act of 1995 (44 U.S.C. 3507(d)) requires
that the FAA consider the impact of paperwork and other information
collection burdens imposed on the public. The FAA has determined that
there is no new requirement for information collection associated with
this proposed rule.

F. International Compatibility

    In keeping with U.S. obligations under the Convention on
International Civil Aviation, it is FAA policy to conform to
International Civil Aviation Organization (ICAO) Standards and
Recommended Practices to the maximum extent practicable. The FAA has
reviewed the corresponding ICAO Standards and Recommended Practices and
has identified no differences with this regulation.

C. barcasEnvironmental Analysis

    FAA Order 1050.1F identifies FAA actions that are categorically
excluded from preparation of an environmental assessment or
environmental impact statement under the National Environmental Policy
Act in the absence of extraordinary circumstances. The FAA has
determined this rulemaking action qualifies for the categorical
exclusion identified in paragraph 5-6.6(d), which covers the issuance
of regulatory documents covering administrative or procedural
requirements and involves no extraordinary circumstances.

V. Executive Order Determinations

A. Executive Order 13132, Federalism

    The FAA has analyzed this proposed rule under the principles and
criteria of Executive Order 13132, ``Federalism.'' The agency
determined that this action will not have a substantial direct effect
on the States, or the relationship between the Federal Government and
the States, or on the distribution of power and responsibilities among
the various levels of government, and, therefore, does not have
Federalism implications.

B. Executive Order 13211, Regulations That Significantly Affect Energy
Supply, Distribution, or Use

    The FAA analyzed this proposed rule under Executive Order 13211,
``Actions Concerning Regulations that Significantly Affect Energy
Supply, Distribution, or Use'' (May 18, 2001). The agency has
determined that it is not a ``significant energy action'' under the
executive order and it is not likely to have a significant adverse
effect on the supply, distribution, or use of energy.

C. Executive Order 13609, International Cooperation

    Executive Order 13609, ``Promoting International Regulatory
Cooperation,'' promotes international regulatory cooperation to meet
shared challenges involving health, safety, labor, security,
environmental, and other issues and to reduce, eliminate, or prevent
unnecessary differences in regulatory requirements. The FAA has
analyzed this action under the policies and agency responsibilities of
Executive Order 13609, and has determined that this action would have
no adverse effect on international regulatory cooperation.

D. Executive Order 13771, Reducing Regulation and Controlling
Regulatory Costs

VI. This Proposed Rule Is Not Expected To Be an E.O. 13771 Regulatory
Action Because This Proposed Rule Is Not Significant Under E.O. 12866.
How To Obtain Additional Information

A. Rulemaking Documents

    An electronic copy of a rulemaking document may be obtained from
the internet by--
    1. Searching the Federal eRulemaking Portal (http://www.regulations.gov);
    2. Visiting the FAA's Regulations and Policies web page at http://www.faa.gov/regulations_policies/; or
    3. Accessing the Government Printing Office's web page at http://www.gpo.gov/fdsys/.
    Copies may also be obtained by sending a request (identified by
notice, amendment, or docket number of this rulemaking) to the Federal
Aviation Administration, Office of Rulemaking, ARM-1, 800 Independence
Avenue SW, Washington, DC 20591, or by calling<PHONE_NUMBER>.

B. Small Business Regulatory Enforcement Fairness Act

    The Small Business Regulatory Enforcement Fairness Act (SBREFA) of
1996 requires FAA to comply with small entity requests for information
or advice about compliance with statutes and regulations within its
jurisdiction. A small entity with questions regarding this document,
may contact its local FAA official, or the person listed under the FOR
FURTHER INFORMATION CONTACT heading at the beginning of the preamble.
To find out more about SBREFA on the internet, visit http://www.faa.gov/regulations_policies/rulemaking/sbre_act/.

List of Subjects in 14 CFR Part 21

    Aircraft, Aviation safety, Exports, Imports, Reporting and
recordkeeping requirements.

The Proposed Amendment

    In consideration of the foregoing, the Federal Aviation
Administration proposes to amend chapter I of title 14, Code of Federal
Regulations as follows:

PART 21--CERTIFICATION PROCEDURES FOR PRODUCTS AND ARTICLES

0
1. The authority citation for part 21 continues to read as follows:

    Authority:  42 U.S.C. 7572; 49 U.S.C. 106(f), 106(g), 40105,
40113, 44701-44702, 44704, 44707, 44709, 44711, 44713, 44715, 45303.

0
2. Amend Sec.  21.20 by revising the introductory text to read as
follows:

Sec.  21.20   Compliance with applicable requirements.

    Except for applications for type certificates of import products
under Sec.  21.29, the applicant for a type certificate, including an
amended or supplemental type certificate, must--
* * * * *

    Issued under authority provided by 49 U.S.C. 106(f) and 44701(a)
in Washington, DC, on February 7, 2019.
Earl Lawerence,
Executive Director, Aircraft Certification Service.
[FR Doc. 2019-02634 Filed 2-21-19; 8:45 am]
 BILLING CODE 4910-13-P


[Federal Register Volume 82, Number 124 (Thursday, June 29, 2017)]
[Rules and Regulations]
[Pages 29424-29426]
[FR Doc No: 2017-13547]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Parts 52 and 70

[EPA-R07-OAR-2015-0790; FRL 9964-04-Region 7]

Approval of Missouri's Air Quality Implementation Plans;
Reporting Emission Data, Emission Fees and Process Information

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule and correcting amendment.

-----------------------------------------------------------------------

SUMMARY: The Environmental Protection Agency (EPA) is taking final
action to approve revisions to the Operating Permits Program for the
State of Missouri submitted on March 16, 2015. These revisions update
the emissions fee for permitted sources as set by Missouri Statute from
$40 to $48 per ton of air pollution emitted annually, effective January
1, 2016. EPA is also responding to comments received on the proposed
action published in the Federal Register on January 15, 2016. In
addition, EPA is making a correction to the previous direct final rule
published in the Federal Register on January 15, 2016. EPA
inadvertently approved and codified this action under both part 52
(Approval and Promulgation of Implementation Plans) and part 70 (State
Operating Permit Programs). This final rule removes the part 52
approval and codification and makes a clarification to the part 70
approval relating to the state effective date.

DATES: This final rule is effective on July 31, 2017.

ADDRESSES: EPA has established a docket for this action under Docket ID
No. EPA-R07-OAR-2015-0790. All documents in the docket are listed on
the http://www.regulations.gov Web site. Although listed in the index,
some information is not publicly available, i.e., 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 at
www.regulations.gov or please contact the person identified in the FOR
FURTHER INFORMATION CONTACT section for additional information. For
additional information and general guidance, please visit http://www2.epa.gov/dockets/commenting-epa-dockets.

FOR FURTHER INFORMATION CONTACT: Amy Algoe-Eakin, Environmental
Protection Agency, Air Planning and Development Branch, 11201 Renner
Boulevard, Lenexa, Kansas 66219 at<PHONE_NUMBER>, or by email at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Throughout this document ``we,'' ``us,'' or
``our'' refer to EPA. This section provides additional information by
addressing the following:

I. What is being addressed in this document?
II. EPA's Response to Comments.
III. What action is EPA taking?

I. What is being addressed in this document?

    EPA is taking final action to approve the state's Title V revision
to 10 C.S.R. 10-6.110 ``Reporting Emission Data, Emission Fees, and
Process Information'', submitted by the state of Missouri on March 16,
2015. This revision updates the emissions fee for permitted sources as
set by Missouri Statute. Specifically, section (3)(A) revises the
emission fees section, which is approved under the Operating Permits
Program only, and updates the emissions fee for permitted sources as
set by Missouri Statute from $40 to $48 per ton of air pollution
emitted annually, effective January 1, 2016.
    In addition, EPA is making a correction to the previous direct
final rule published in the Federal Register on January 15, 2016 (81 FR
2090). In that action, EPA inadvertently approved and codified the
state's submission relating to Missouri rule 10 CSR 6.110(3)(a)
pursuant to 40 CFR part 52 (Approval and Promulgation of Implementation
Plans) and part 70 (State Operating Permit Programs). This action
corrects the error by recodifying table (c) of Sec.  52.1320 back to
its previously approved and codified entry (76 FR 77701, 12/14/11). EPA
is only approving this action pursuant to 40 CFR part 70 per the
state's submission request. Also, the January 15, 2016, direct final
rule approved and added new paragraph (ee) to part 70 appendix A. The
new paragraph (ee) erroneously listed the state effective date of
November 20, 2014. The correct state effective date is March 30, 2015.
This final action revises paragraph (ee) to read as set out in the
regulatory text below.

II. EPA's Response to Comments

    The public comment period on EPA's proposed rule (81 FR 2159,
January 15, 2016) opened January 15, 2016, the date of its publication
in the Federal Register, and closed on February 16, 2016. During this
period, EPA received one comment.
    Comment: The commenter expressed concern with the intent to
increase fees on pollutant emissions and the subsequent use of those
fees once collected. The commenter understood that the fees were
collected to fund the state's regulatory activities. However, the
commenter questioned how those funds would be used by the state and

expressed that the EPA ``should insure the first result of spending any
fees be protecting human health and the environment'' and ``unless
strict rules are imposed and regular performance audits conducted in a
transparent and open way, higher fees would be an incentive for
regulators to allow greater pollutant loads with the simple objective
of collecting more fees to support their staff and to increase staff
size.''
    EPA Response: CAA section 502(b)(3)(A) 42 U.S.C. 7661a (b)(3)(A)
requires the permitting authority to collect a fee sufficient to cover
all reasonable direct and indirect costs required to develop and
administer the Title V permit program, including enforcement. The CAA
and agency regulation 40 CFR 70.9 require permitting authorities to
submit a fee demonstration with their Title V operating permits
program. EPA has approved Missouri's Title V permit program fee and
determined it meets the requirements of the CAA and EPA guidance
regarding the fee demonstration. The fees also include costs associated
with all aspects of the Title V permit program (reviewing applications,
emissions, ambient monitoring, preparing regulations, modeling).

III. What action is EPA taking?

    Upon review and consideration of comments received, EPA is taking
final action to approve the state's Title V revision to 10 C.S.R. 10-
6.110 ``Reporting Emission Data, Emission Fees, and Process
Information'', submitted by the state of Missouri on March 16, 2015.
Based upon review of the state's revision and relevant requirements of
the CAA, EPA believes that this revision meets applicable requirements
and does not adversely impact air quality in Missouri.
    EPA is also making a correction which will remove approval of the
state's submission from 40 CFR part 52, specifically Sec.  52.1320(c),
EPA-Approved Missouri Regulations and revert to the previously codified
table (76 FR 77701, 12/14/11). This action also revises paragraph (ee)
part 70, appendix A to correct the state effective date.

IV. Incorporation by Reference

    In this rule, EPA is finalizing regulatory text that includes
incorporation by reference. In accordance with requirements of 1 CFR
51.5, the EPA is finalizing the incorporation by reference of the
Missouri amendments to 40 CFR part 52 set forth below. Therefore, these
materials have been approved by EPA for inclusion in the State
implementation plan, have been incorporated by reference by EPA into
that plan, are fully Federally enforceable under sections 110 and 113
of the CAA as of the effective date of the final rulemaking of EPA's
approval, and will be incorporated by reference by the Director of the
Federal Register in the next update to the SIP compilation.\1\ EPA has
made, and will continue to make, these materials generally available
through www.regulations.gov and/or at the EPA Region 7 Office (please
contact the person identified in the FOR FURTHER INFORMATION CONTACT.
section of this preamble for more information).
---------------------------------------------------------------------------

    \1\ 62 FR 27968 (May 22, 1997).
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V. Statutory and Executive Order Reviews

    Under the CAA, the Administrator is required to approve a
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, EPA's role is to approve state choices,
provided that they meet the criteria of the CAA. Accordingly, this
action merely approves state law as meeting Federal requirements and
does not impose additional requirements beyond those imposed by state
law. For that reason, this action:
     Is not a significant regulatory action subject to review
by the Office of Management and Budget under Executive 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 (Public Law 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 Section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272
note) because application of those requirements would be inconsistent
with the CAA; and
     Does not provide EPA with the discretionary authority to
address, as appropriate, disproportionate human health or environmental
effects, using practicable and legally permissible methods, under
Executive Order 12898 (59 FR 7629, February 16, 1994).
    The action 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).
    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 August 28, 2017. 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, Carbon monoxide,
Incorporation by reference, Intergovernmental relations, Lead, Nitrogen
dioxide, Ozone, Particulate

matter, Reporting and recordkeeping requirements, Sulfur oxides,
Volatile organic compounds.

40 CFR Part 70

    Environmental protection, Administrative practice and procedure,
Air pollution control, Intergovernmental relations, Operating permits,
Reporting and recordkeeping requirements.

    Dated: June 12, 2017.
Edward H. Chu,
Acting Regional Administrator, Region 7.
    For the reasons stated in the preamble, EPA amends 40 CFR parts 52
and 70 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.

0
2. In Sec.  52.1320, paragraph (c) is amended by revising the entry for
10-6.110 to read as follows:

Sec.  52.1320  Identification of plan.

* * * * *
    (c) * * *

                                        EPA-Approved Missouri Regulations
----------------------------------------------------------------------------------------------------------------
                                                             State
       Missouri  citation                 Title            effective      EPA approval          Explanation
                                                              date            date
----------------------------------------------------------------------------------------------------------------
                                    Missouri Department of Natural Resources
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------
    Chapter 6--Air Quality Standards, Definitions, Sampling and Reference Methods, and Air Pollution Control
                                      Regulations for the State of Missouri
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
10-6.110.......................  Submission of Emission       9/30/10  12/14/11, 76 FR    Section (3)(A),
                                  Data, Emission Fees,                  77701.             Emissions Fees, has
                                  and Process                                              not been approved as
                                  Information.                                             part of the SIP.

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------

* * * * *

PART 70--STATE OPERATING PERMIT PROGRAMS

0
3. The authority citation for part 70 continues to read as follows:

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

0
4. Appendix A to part 70 is amended by revising paragraph (ee) under
Missouri to read as follows:

Appendix A to Part 70--Approval Status of State and Local Operating
Permits Programs

* * * * *
Missouri
* * * * *
    (ee) The Missouri Department of Natural Resources submitted
revisions to Missouri rule 10 CSR 10-6.110, ``Reporting Emission
Data, Emission Fees, and Process Information'' on March 16, 2015.
The state effective date is March 30, 2015. This revision is
effective July 31, 2017.
* * * * *
[FR Doc. 2017-13547 Filed 6-28-17; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register Volume 82, Number 167 (Wednesday, August 30, 2017)]
[Notices]
[Page 41273]
[FR Doc No: 2017-18375]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-N-0002]

Upsher-Smith Laboratories, Inc.; Withdrawal of Approval of an
Abbreviated New Drug Application for PROPRANOLOL HYDROCHLORIDE

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or the Agency) is
withdrawing approval of an abbreviated new drug application (ANDA) for
PROPRANOLOL HYDROCHLORIDE Extended-Release Capsules, held by Upsher-
Smith Laboratories, Inc. (Upsher-Smith), 6701 Evenstad Dr., Maple
Grove, MN 55369. Upsher-Smith has voluntarily requested that approval
of this application be withdrawn and has waived its opportunity for a
hearing.

DATES: August 30, 2017.

FOR FURTHER INFORMATION CONTACT: Stefanie Kraus, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6215, Silver Spring, MD 20993-0002, 301-
796-9585.

SUPPLEMENTARY INFORMATION: On March 6, 2009, FDA approved abbreviated
new drug application (ANDA) 078311 for PROPRANOLOL HYDROCHLORIDE
Extended-Release Capsules, USP, 60 milligrams (mg), 80 mg, 120 mg, and
160 mg. In a letter dated August 9, 2011, FDA informed Upsher-Smith
that it had concerns about the validity of bioequivalence data
submitted with ANDA 078311 from studies conducted by a certain contract
research organization, establishing bioequivalence of Upsher-Smith's
product to the reference listed drug (RLD), INDERAL LA (propranolol
hydrochloride) Extended Release Capsules, 60 mg, 80 mg, 120 mg, and 160
mg. In that letter, FDA directed Upsher-Smith to supplement its ANDA
with either: (1) New bioequivalence studies or (2) re-assays of the
samples from the original bioequivalence studies. Upsher-Smith
submitted new fasted and fed bioequivalence studies to supplement ANDA
078311 in paper format on August 29, 2013, and in electronic format on
May 9, 2014.
    On April 14, 2016, FDA informed Upsher-Smith that the applicant's
fed bioequivalence study failed to meet FDA's bioequivalence criteria
and, therefore, requested that Upsher-Smith voluntarily seek withdrawal
of ANDA 078311 under Sec.  314.150(d) (21 CFR 314.150(d)).
    In a letter dated May 13, 2016, Upsher-Smith requested that FDA
withdraw approval of ANDA 078311 for PROPRANOLOL HYDROCHLORIDE
Extended-Release Capsules under Sec.  314.150(d) because the new
bioequivalence data did not demonstrate therapeutic equivalence of its
product to the RLD, INDERAL LA. In that letter, Upsher-Smith also
waived any opportunity for a hearing otherwise provided under Sec.
314.150(a).
    Therefore, under section 505(e) of the Federal Food, Drug, and
Cosmetic Act (FD&C Act) (21 U.S.C. 355(e)) and Sec.  314.150(d), and
under authority delegated by the Commissioner of Food and Drugs to the
Director, Center for Drug Evaluation and Research, approval of ANDA
078311, and all amendments and supplements thereto, is withdrawn (see
DATES). Distribution of this product in interstate commerce without an
approved application is illegal and subject to regulatory action (see
sections 505(a) and 301(d) of the FD&C Act (21 U.S.C. 355(a) and
331(d)).

    Dated: August 24, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-18375 Filed 8-29-17; 8:45 am]
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