[Federal Register Volume 84, Number 57 (Monday, March 25, 2019)]
[Notices]
[Pages 11105-11106]
[FR Doc No: 2019-05657]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-N-1134]

Development of Antibacterial Drugs for the Treatment of
Nontuberculous Mycobacterial Disease; Public Workshop; Request for
Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshop; request for comments.

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SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is
announcing the following public workshop entitled ``Development of
Antibacterial Drugs for the Treatment of Nontuberculous Mycobacterial
Disease.'' The purpose of the public workshop is to discuss the
clinical trial design considerations, including endpoints, related to
the development of antibacterial drug products for treatment of
nontuberculous mycobacterial (NTM) disease.

DATES: The public workshop will be held on April 8, 2019, from 8:30
a.m. to 5 p.m. Submit either electronic or written comments on this
public workshop by May 16, 2019. See the SUPPLEMENTARY INFORMATION
section for registration date and information.

ADDRESSES: The public workshop will be held at FDA's White Oak Campus,
10903 New Hampshire Ave., Building 31, Conference Center, the Great
Room (Rm. 1503), Silver Spring, MD 20993. Entrance for the public
workshop participants (non-FDA employees) is through Building 1 where
routine security check procedures will be performed. For parking and
security information, please refer to https://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm.
    You may submit comments as follows. Please note that late, untimely
filed comments will not be considered. Electronic comments must be
submitted on or before May 16, 2019. The https://www.regulations.gov
electronic filing system will accept comments until 11:59 p.m. Eastern
Time on May 16, 2019. Comments received by mail/hand delivery/courier
(for written/paper submissions) will be considered timely if they are
postmarked or the delivery service acceptance receipt is on or before
that date.

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-2019-N-1134 for ``Development of Antibacterial Drugs for the
Treatment of Nontuberculous Mycobacterial Disease.'' Received comments,
those filed in a timely manner (see ADDRESSES), 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.
     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.gpo.gov/fdsys/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.

FOR FURTHER INFORMATION CONTACT: Lori Benner and/or Jessica Barnes,
Center for Drug Evaluation and Research, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 22, Rm. 6221, Silver Spring, MD 20993-
0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing a public workshop regarding the development of
antibacterial drugs for the treatment of NTM disease. Discussions will
focus on clinical trial design considerations, including endpoints,
related to drug development for the treatment of NTM disease.

II. Topics for Discussion at the Public Workshop

    FDA is particularly interested in discussing challenges and
considerations regarding drug development for NTM disease.

    Discussions are planned around the following topics areas:

 Trial design
 Trial endpoints
 Trial populations

    The Agency encourages health care providers, other U.S. Government
Agencies, academic experts, industry, and other stakeholders to attend
this public workshop.

III. Participating in the Public Workshop

    Registration: Registration is free and based on space availability.
Persons interested in attending this public workshop must register
online by April 4, 2019, midnight Eastern Time. To register, please
provide complete contact information for each attendee, including name,
title, affiliation, address, email, and telephone to https://www.eventbrite.com/e/development-of-antibacterial-drugs-for-the-treatment-of-nontuberculous-mycobacterial-disease-tickets-54145569857.
    Early registration is recommended because seating is limited;
therefore, FDA may limit the number of participants from each
organization. Registrants will receive confirmation when they have been
accepted. If time and space permit, onsite registration on the day of
the public workshop will be provided beginning at 7:30 a.m. We will let
registrants know if registration closes before the day of the public
workshop.
    If you need special accommodations due to a disability, please
contact Jessica Barnes or Lori Benner (see FOR FURTHER INFORMATION
CONTACT) no later than April 1, 2019.
    Requests for Oral Presentations: During online registration you may
indicate if you wish to present during a public comment session or
participate in a specific session, and which topic(s) you wish to
address. We will do our best to accommodate requests to make public
comments. Individuals and organizations with common interests are urged
to consolidate or coordinate their presentations, and request time for
a joint presentation, or submit requests for designated representatives
to participate in the focused sessions. We will determine the amount of
time allotted to each presenter and the approximate time each oral
presentation is to begin and will select and notify participants by
March 29, 2019. All requests to make oral presentations must be
received by March 25, 2019. If selected for presentation, any
presentation materials must be emailed to
<EMAIL_ADDRESS>no later than April 3, 2019. No
commercial or promotional material will be permitted to be presented or
distributed at the public workshop.
    Streaming Webcast of the Public Workshop: This public workshop will
also be webcast at the following site: https://collaboration.fda.gov/r1s6qm9hgylr/.
    If you have never attended a Connect Pro event before, test your
connection at https://collaboration.fda.gov/common/help/en/support/meeting_test.htm. To get a quick overview of the Connect Pro program,
visit https://www.adobe.com/go/connectpro_overview. FDA has verified
the website addresses in this document, as of the date this document
publishes in the Federal Register, but websites are subject to change
over time.
    Transcripts: Please be advised that as soon as a transcript of the
public workshop is available, it will be accessible at https://www.regulations.gov. It may be viewed at the Dockets Management Staff
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852. A link to the transcript will also be available on
the internet at https://www.fda.gov/Drugs/NewsEvents/ucm629494.htm.

    Dated: March 20, 2019.
Lowell J. Schiller,
Acting Associate Commissioner for Policy.
[FR Doc. 2019-05657 Filed 3-22-19; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 83, Number 41 (Thursday, March 1, 2018)]
[Proposed Rules]
[Pages 8822-8827]
[FR Doc No: 2018-04112]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R09-OAR-2018-0080; FRL-9974-95--Region 9]

Revisions to California State Implementation Plan; Bay Area Air
Quality Management District; Stationary Sources; New Source Review

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: The Environmental Protection Agency (EPA) is proposing to
approve revisions to the Bay Area Air Quality Management District
(BAAQMD or District) portion of the California State Implementation
Plan (SIP). These revisions concern permit program rules governing the
issuance of permits for stationary sources, including review and
permitting of major sources and major modifications under parts C and D
of title I of the Clean Air Act (CAA). The revisions correct
deficiencies in BAAQMD Regulation 2, Rules 1 and 2, and Regulation 2,
Rule 4, previously identified by the EPA in final rules dated August 1,
2016, and December 4, 2017, respectively. We are proposing to approve
revisions that correct the identified deficiencies.

DATES: Any comments must arrive by April 2, 2018.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-R09-
OAR-2018-0080 at http://www.regulations.gov, or via email to
[email protected]. For comments submitted at Regulations.gov, follow
the online instructions for submitting comments. Once submitted,
comments cannot be removed or edited from Regulations.gov. For either
manner of submission, the EPA may publish any comment received to its
public docket. Do not submit electronically any information you
consider to be Confidential Business Information (CBI) or other
information whose disclosure is restricted by statute. Multimedia
submissions (audio, video, etc.) must be accompanied by a written
comment. The written comment is considered the official comment and
should include discussion of all points you wish to make. The EPA will
generally not consider comments or comment contents located outside of
the primary submission (i.e. on the web, cloud, or other file sharing
system). For additional submission methods, please contact the person
identified in the FOR FURTHER INFORMATION CONTACT section. For the full
EPA public comment policy, information about CBI or multimedia
submissions, and general guidance on making effective comments, please
visit http://www2.epa.gov/dockets/commenting-epa-dockets.

FOR FURTHER INFORMATION CONTACT: Laura Yannayon, EPA Region 9, (415)
972-3534, [email protected].

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

Table of Contents

I. The State's Submittal
    A. What rules did the State submit?
    B. Are there other versions of these rules?
    C. What is the purpose of the submitted rule revisions?
II. The EPA's Evaluation and Action
    A. How is the EPA evaluating the rules?
    B. Do the rules meet the evaluation criteria?
    1. Regulation 2, Rules 1 and 2
    2. Regulation 2, Rule 4
    3. Requirements of 40 CFR 51.165(a)(13)
    4. Sections 110(a)(2) and 110(l) of the Act
    5. Section 193 of the Act
III. Proposed Action and Public Comment
IV. Incorporation by Reference
V. Statutory and Executive Order Reviews

Definitions

    For the purpose of this document, we are giving meaning to certain
words or initials as follows:
    (i) The word or initials Act or CAA mean or refer to the Clean Air
Act, unless the context indicates otherwise.

    (ii) The word or initials APCO mean or refer to the Air Pollution
Control Officer.
    (iii) The word or initials BAAQMD or District mean or refer to the
Bay Area Air Quality Management District.
    (iv) The initials BACT mean or refer to Best Available Control
Technology.
    (v) The words Bay Area mean or refer to the geographic area
regulated by the Bay Area Air Quality Management District.
    (vi) The initials CARB mean or refer to the California Air
Resources Board.
    (vii) The initials CFR mean or refer to Code of Federal
Regulations.
    (viii) The initials or words EPA, we, us or our mean or refer to
the United States Environmental Protection Agency.
    (ix) The initials ERC mean or refer to Emission Reduction Credit.
    (x) The initials FR mean or refer to Federal Register.
    (xi) The initials GHG mean or refer to greenhouse gases.
    (xii) The initials NAAQS mean or refer to National Ambient Air
Quality Standards.
    (xiii) The initials NOX mean or refer to oxides of nitrogen.
    (xiv) The initials NSR mean or refer to New Source Review.
    (xv) The initials PM2.5 mean or refer to particulate matter with an
aerodynamic diameter of less than or equal to 2.5 micrometers (fine
particulate matter).
    (xvi) The initials POC mean or refer to precursor organic compound.
    (xvii) The initials PSD mean or refer to Prevention of Significant
Deterioration.
    (xviii) The initials PTE mean or refer to potential to emit
    (xix) The initials SIP mean or refer to State Implementation Plan.
    (xx) The initials SO2 mean or refer to sulfur dioxide.
    (xxi) The initials VOC mean or refer to volatile organic compound.

I. The State's Submittal

A. What rules did the State submit?

    Table 1 lists the rules addressed by this proposal with the dates
they were adopted by BAAQMD and submitted by the CARB, which is the
governor's designee for California SIP submittals. Regulation 2, Rule 1
contains general requirements that apply to all District air quality
permitting programs. Regulation 2, Rule 2 contains the District's New
Source Review (NSR) permit programs for both attainment and
nonattainment pollutants. Regulation 2, Rule 4 contains requirements
for banking emission reduction credits (ERCs).

                                            Table 1--Submitted Rules
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             Regulation & Rule No.                         Rule title                 Amended        Submitted
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Regulation 2, Rule 1 (Rule 2-1)...............  Permits, General Requirements...       12/6/2017        12/14/17
Regulation 2, Rule 2 (Rule 2-2)...............  Permits, New Source Review......       12/6/2017        12/14/17
Regulation 2, Rule 4 (Rule 2-4)...............  Permits, Emissions Banking......       12/6/2017        12/14/17
----------------------------------------------------------------------------------------------------------------

    On February 14, 2018, the EPA determined that the submittal of
Regulation 2, Rules 1, 2 and 4 met the completeness criteria in 40 CFR
part 51, appendix V, which must be met before formal EPA review.

B. Are there other versions of these rules?

    The existing SIP-approved NSR program for new or modified
stationary sources in the Bay Area consists of the rules identified
below in Table 2. The EPA's approval of the rules identified above in
Table 1 would have the effect of entirely superseding our prior
approval of these rules in the current SIP-approved program.

                                           Table 2--Existing SIP Rules
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             Regulation & Rule No.                         Rule title              Approval date    FR citation
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Regulation 2, Rule 1 (Rule 2-1)...............  Permits, General Requirements...        8/1/2016     81 FR 50339
Regulation 2, Rule 2 (Rule 2-2)...............  Permits, New Source Review......        8/1/2016     81 FR 50339
Regulation 2, Rule 4 (Rule 2-4)...............  Permits, Emissions Banking......       12/4/2017     82 FR 57133
----------------------------------------------------------------------------------------------------------------

C. What is the purpose of the submitted rule revisions?

    This SIP submittal is intended to correct deficiencies previously
identified by the EPA in our August 1, 2016, limited approval and
limited disapproval ction for Rules 2-1 and 2-2 (81 FR 50339), and our
December 4, 2017, conditional approval action for Rule 2-4 (82 FR
57133).

II. The EPA's Evaluation and Action

A. How is the EPA evaluating the rules?

    The evaluation criteria for the submitted rules includes compliance
with the CAA's requirements for SIPs in CAA sections 110(a)(2), 110(l),
and 193. In addition, the EPA evaluated the submitted rules for
consistency with the regulatory provisions of 40 CFR part 51, subpart I
(Review of New Sources and Modifications) (i.e., 40 CFR 51.160-51.166)
and 40 CFR 51.307.

B. Do the rules meet the evaluation criteria?

    In our previous August 1, 2016, and December 4, 2017, actions we
evaluated prior submissions of the submitted rules in accordance with
the CAA and regulatory requirements listed in Section II.A of this
document. In those actions, we determined that for the most part the
submitted rules satisfied the applicable requirements for NSR permit
programs. However, in each action we identified certain deficiencies
that prevented full approval. For both of the previous actions, we list
the identified deficiencies and evaluate whether the submitted rule
revisions correct the deficiency. We also evaluate any additional rule
revisions and whether the submittal complies with the requirements of
sections 110(a)(2), 110(l) and 193 of the CAA.
1. Regulation 2, Rules 1 and 2
    Our August 1, 2016 action identified the following eleven
deficiencies in Rules 2-1 and 2-2.
    First, the definitions of ``agricultural source'' in Section 2-1-
239 and ``large confined animal facility'' used in Section 2-1-424 rely
on other definitions and provisions in District rules that are not SIP
approved.
    Second, Section 2-1-234, subparagraph 2.2, is deficient because it

does not satisfy the PSD provisions at 40 CFR 51.166(a)(7) and
51.166(r)(6) & (7), which require PSD programs to contain specific
applicability procedures and recordkeeping provisions.
    Third, the same deficiency discussed above for the PSD provisions
applies to the nonattainment NSR provisions. Section 2-1-234,
subparagraph 2.1, does not satisfy the requirements of 40 CFR
51.165(a)(2) and 51.165(a)(6) & (7), which require nonattainment NSR
programs to contain specific applicability procedures and recordkeeping
provisions.
    Fourth, the definition of the term ``PSD pollutant'' as defined in
Section 2-2-223, which is used in place of the federal definition for
the term ``regulated NSR pollutant,'' is deficient because it
explicitly excludes nonattainment pollutants.
    Fifth, Section 2-2-305 does not require written approval of the
Administrator prior to using any modified or substituted air quality
model as provided in subsection 3.2.2 of 40 CFR part 51, appendix W.
    Sixth, Section 2-2-611 does not include the requirement regarding
``any other stationary source category which as of August 7, 1980, is
being regulated under section 111 or 112 of the Act'' in the list of
source categories that must include fugitive emissions to determine
whether a source is a major facility.
    Seventh, Section 2-2-401.4 only requires a visibility analysis for
sources that are located within 100 km of a Class I area, rather than
for any source that ``may have an impact on visibility'' in any
mandatory Class I Federal Area, as required by 40 CFR 51.307(b)(2).
    Eighth, Section 2-2-411 pertaining to Offset Refunds does not
contain any timeframe for obtaining an offset refund.
    Ninth, the Offset Program Equivalence demonstration required by
Section 2-2-412 does not provide a remedy if the District fails to make
the required demonstration.
    Tenth, Subsection 2-2-605.2 allows existing ``fully-offset''
sources to generate ERCs based on the difference between the post-
modification PTE and the pre-modification PTE. Emission reductions
intended to be used as offsets for new major sources or major
modifications are only creditable if they are reductions of actual
emissions, not reductions in the PTE of a source.
    Eleventh, Subsection 2-2-606.2, as it applies to major
modifications, does not require ``fully-offset'' sources to calculate
the emission increases from a proposed major modification based on the
difference between the post-modification PTE and the pre-modification
actual emissions as required by 40 CFR 51.165(a)(3)(ii)(J).
    To address the first deficiency, the definition of ``agricultural
source'' in Section 2-1-239 and the reference to ``large confined
animal facility'' used in Section 2-1-424 have been revised to remove
references to ``Regulation 2, Rule 10,'' which is not SIP approved. The
District made additional edits to both of these provisions, as well as
Subsection 2-1-113.1.2, to provide additional information due to the
removal of the references to Regulation 2, Rule 10. These revisions
cure this deficiency because the rules no longer reference rules which
are not SIP approved.
    To address the second deficiency, Section 2-1-234 has been revised
by adding two new subparagraphs (2.3 and 2.4) to include the specific
applicability procedures and recordkeeping provisions required by 40
CFR 51.166(a)(7) and 51.166(r)(6) & (7). These two new subparagraphs
are acceptable to cure this deficiency.
    To address the third deficiency, Section 2-1-234 has been revised
by adding two new subparagraphs (2.3 and 2.4) to include the specific
applicability procedures and recordkeeping provisions required by 40
CFR 51.165(a)(2) and 51.165(a)(6) & (7). These two new subparagraphs
are acceptable to cure this deficiency.
    To address the fourth deficiency, Section 2-2-224 has been revised
to reference the term ``Regulated NSR Pollutant'' rather than ``PSD
pollutant.'' This revision cures the deficiency by ensuring that a
Major PSD Facility determination (as specified in Subsection 224.1) is
based on emissions of all regulated NSR pollutants, including any
nonattainment pollutant.
    To address the fifth deficiency, Section 2-2-305.3--Air Quality
Models, has been revised to require written EPA approval prior to using
any modified or substituted air quality model. This revision cures this
deficiency.
    To address the sixth deficiency, Section 2-2-611 has been revised
to add the following language: ``or is in any other stationary source
category that was being regulated under section 111 or 112 of the Clean
Air Act as of August 7, 1980.'' This revision cures this deficiency by
adding the missing required language.
    To address the seventh deficiency, Section 2-2-401.4 has been
revised to indicate an analysis of potential impacts to air quality
related values is required for a project which ``may have an impact on
air quality related values (including visibility) within any Class I
area(s),'' rather than only projects located within 100 km of a Class I
area. In addition, language has been added to this section to clarify
how such a determination is to be made by referencing the guidelines
adopted by the Federal Land Managers Air Quality Related Values Work
Group. These revisions cure this deficiency.
    To address the eighth deficiency, Section 2-2-411.1 has been
revised to specify that if excess offsets are provided, an offset
refund request must be made within 2 years of the issuance of the
authority to construct or within 6 months of issuance of the permit to
operate. Section 2-2-411.2 has been revised to specify that if a source
is never constructed or operated, and the authority to construct for
the source has expired or been surrendered, an offset refund request
must be made within 2 years of the issuance or renewal of the authority
to construct. These revisions cure this deficiency.
    To address the ninth identified deficiency, Section 2-2-415--
Additional Offset Requirements Where District Has Not Demonstrated
NOX, POC or PM2.5 Offset Program Equivalence, has
been added to specify that if the demonstration required by Section 2-
2-412 is not made by March 1 of each year (or other EPA-approved date),
the Air Pollution Control Officer (APCO) shall require additional
offsets for any subsequent Authority to Construct and/or Permit to
Operate for a Federal Major NSR Source sufficient to make up for (i)
any Federal Offsets Baseline Shortfall calculated pursuant to Section
2-2-229 and (ii) any Federal Surplus-at-Time-of-Use Shortfall
calculated pursuant to Section 2-2-230. The new provision also states
that this requirement shall continue until the District has made the
required equivalence demonstration.
    These new provisions cure this deficiency because they ensure an
applicant will provide the full amount of federal offsets required for
a new project if the District fails to make the required annual
demonstration. The EPA recognizes that any shortfall for a year in
which the District does not provide an adequate demonstration will not
be immediately corrected, but it will be corrected prior to continued
usage of the offset equivalence demonstration. The EPA finds this
acceptable.
    To address the tenth identified deficiency, Subsection 2-2-605.1
has been revised to clarify the requirements of an eligible emission
reduction credit and Subsection 2-2-605.2 has been revised to eliminate
a separate calculation methodology for ``fully-offset'' sources. The
provision has also been revised to specify that the amount

of emission reduction shall be calculated as the difference between:
(i) The source's adjusted baseline emissions before the change
calculated pursuant to Section 2-2-603; and (ii) the source's potential
to emit after the change. This revision cures this deficiency because
it ensures that the amount of ERC is based on actual emission
reductions.
    To address the eleventh identified deficiency, the calculation
methodology specified in Subsection 2-2-606.2 was not revised. Instead,
Section 2-2-412--Demonstration of NOX, POC and
PM2.5 Offset Program Equivalence, was revised to require the
District to provide an annual demonstration that the District's NSR
program as a whole has obtained at least as many NOX, POC
and PM2.5 offsets as would have been required pursuant to
the provisions of 40 CFR 51.165 for federal major sources during the
previous calendar year. We note that although section 2-2-412 was
modified to include PM2.5, the revisions to Section 2-2-412
do not contain any provisions for demonstrating equivalency with
SO2 offset requirements. In section II.B.3 of this preamble
we discuss our reasoning for proposing approval of Rule 2-2 without
requiring an equivalency demonstration for SO2 offsets.
    In addition, new definitions for the terms Federal Major NSR
Source, Federal Offsets Baseline Shortfall, Federal Surplus-at-Time of
Use Shortfall and Equivalence Credit were added to define these terms
as used in Section 2-2-412. We find these new definitions acceptable.
    In the current SIP, the annual Offset Program Equivalence
Demonstration is only required to account for the difference between
the quantity of offsets obtained by the District using ERCs surplus
adjusted solely at the time of generation and the subset of those
offsets that continue to be surplus at the time of use. The new
provisions require the District to also calculate the difference
between the amount of offsets provided pursuant to the provisions of
Subsection 2-2-606.2, and the amount required pursuant to the
provisions of 40 CFR 51.165, when applied to new and modified major
sources. We have reviewed the language added to Section 2-2-412 and new
Section 2-2-415, and have determined that the provisions of Rule 2-2
will ensure that in the aggregate an equivalent number of ERCs will be
provided as would otherwise be required by a NSR program without an
equivalence mechanism that met the offset quantification provisions
specified in 40 CFR 51.165. We find that these revised and new
provisions are acceptable to cure this deficiency.
    In addition to the revisions made to address the identified
deficiencies discussed above, the District made several additional
minor rule revisions. In Rule 2-1, the definitions for the terms
``Facility'' and ``New Source'' were revised to provide additional
clarification regarding portable equipment. The provisions of
Subsection 2-1-234.2 were revised to clarify which specific provisions
of 40 CFR 51.165 (for nonattainment pollutants) and 40 CFR 52.21 (for
other Federal NSR pollutants) must be used to determine if an emissions
increase from a project will result in a major modification as defined
in 40 CFR 51.165 or 52.21, as applicable. These revisions provide
important clarifications to ensure the provisions are enforceable, as
required by CAA section 110(a)(2)(C), and do not revise any of the
requirements for determining if a project will result in a major
modification. Therefore we find the revisions to Subsection 2-1-234.2
acceptable. Section 2-1-413--Permits for Operation of Equipment at
Multiple Locations Within the District, was revised by adding new
Subsection 413.7. This new provision ensures that equipment permitted
under this provision do not effectively become ``stationary source
equipment'' by residing at a single stationary source for more than 12
months. We find these revisions acceptable. Revisions were also made to
Section 2-1-424--Loss of Exemption or Exclusion to remove the reference
to non-SIP approved Rule 2-10, and provide additional clarification
regarding the applicability of this provision. These revisions do not
change the requirements of this section, therefore we find the
revisions acceptable.
    In Rule 2-2, the definitions for the terms ``Adjustment to Emission
Reductions for Federal Purposes'' and ``Fully Offset Source'' were
deleted because the rule no longer uses these terms. In Section 2-2-
214, the definition of ``Greenhouse Gases'' was revised to remove the
requirement that such gases be measured on a mass basis consistent with
the Supreme Court's decision in Utility Air Regulatory Group v. EPA,
and the subsequent Judgment in the United States Court of Appeals for
the District of Columbia Circuit in Coalition for Responsible
Regulation, Inc. v. EPA regarding the treatment of GHGs in the PSD
program.\1\
---------------------------------------------------------------------------

    \1\ In 2014 the U.S. Supreme Court issued a ruling in Utility
Air Regulatory Group v. EPA, 134 S.Ct. 2427 (2014) that interpreted
several relevant provisions of the federal Clean Air Act regarding
the Act's PSD permit program requirements. On April 10, 2015, the
D.C. Circuit Court of Appeals effectuated the Supreme Court's
judgment by vacating portions of the EPA's PSD regulations
addressing GHGs. See Coalition for Responsible Regulation, Inc. v.
EPA, 606 Fed. Appx. 6 (Apr. 10, 2015).
---------------------------------------------------------------------------

2. Regulation 2, Rule 4
    Our December 4, 2017 action identified the following three
deficiencies in Rule 2-4.
    First, Rule 2-4 is deficient because it defines the term ERCs as
emission reductions ``that are in excess of the reductions required by
applicable regulatory requirements, and that are real, permanent,
quantifiable, and enforceable,'' but does not contain any enforceable
provisions requiring the APCO to determine that the emission reductions
under review meet the offset integrity criteria prior to issuing an ERC
Certificate.
    Second, Rule 2-4 is deficient because it incorporates the deficient
emission reduction calculation procedures found in Rule 2-2 subsection
605.2. This deficiency in Rule 2-2-605.2 is discussed in Section II.B.1
of the present document, and is identified as deficiency number ten.
    Third, Rule 2-4 is deficient because Section 2-4-302.3 allows ERC
Certificates to be issued that do not adequately ensure the permanency
of an emission reduction due to a facility closure.
    To address the first deficiency, Section 2-4-301 has been revised
by adding language clarifying that emission reductions may be banked
only if the APCO determines (i) that the reductions satisfy all of the
criteria necessary to constitute Emission Reduction Credits as defined
in Section 2-2-211, including but not limited to the requirements that
the reductions are real, permanent, quantifiable, and enforceable, and
are calculated in accordance with Section 2-2-605; and (ii) that
banking the reductions is not prohibited by Section 2-4-303. These
revisions cure this deficiency because they ensure that emission
reductions may only be banked after the APCO determines the offset
integrity criteria have been met.
    To address the second deficiency, Section 2-2-605.2 has been
revised to eliminate a separate calculation methodology for ``fully-
offset'' sources. This revision is discussed in more detail in section
II.B.1 of the present document in the discussion of deficiency number
ten. Because the second identified deficiency in Rule 2-4 stems from
the incorporation of a deficiency in Section 2-2-605.2, and we found in
Section

II.B.1 above that the District's amendments to Rule 2-2 cure this
deficiency, we also find that the corresponding deficiency cited in
Rule 2-4 pertaining to how the quantity of an emission reduction is
calculated has been cured.
    To address the third identified deficiency, Section 2-4-302.3 has
been removed from Rule 2-4. This revision cures this deficiency by
removing the deficient provision.
    In addition to the revisions to Rule 2-4 discussed above, the
District deleted Section 301.7, which provided an example of a bankable
emission reduction. Because this was only an example, this deletion has
no effect on the approvability of Rule 2-4.
    Our December 4, 2017, conditional approval action (82 FR 57133) was
predicated on the state's commitment to submit SIP revisions to cure
the three identified deficiencies. Because we are proposing to find
that the present submission cures these deficiencies, we also propose
to find that the state has fulfilled its commitment. If finalized as
proposed, the EPA would fully approve the submitted version of Rule 2-4
into the SIP, curing the previously identified deficiencies, and remove
the conditional approval contained in 40 CFR 52.248(c).
3. Requirements of 40 CFR 51.165(a)(13)
    For any area designated nonattainment for PM2.5, 40 CFR
51.165(a)(13) requires a nonattainment NSR program to require the same
control requirements applicable to major stationary sources and major
modifications of PM2.5 to all PM2.5 precursors. A
permitting authority may exclude a specific precursor from this
requirement if they submit--and the EPA approves--a precursor
demonstration that meets the conditions for a nonattainment NSR
precursor demonstration as set forth in 40 CFR 51.1006(a)(3). In our
August 1, 2016 action we found that Rule 2-2 satisfied the requirements
of CAA section 189(e), which are now enacted through 40 CFR
51.165(a)(13), for SO2, NOX, and VOC, and we
approved a demonstration for ammonia allowing it to be excluded from
this requirement.\2\ A nonattainment NSR precursor demonstration must
``evaluate the sensitivity of PM2.5 levels in the
nonattainment area to an increase in emissions of a particular
precursor.'' If the changes ``are not significant, based on the facts
and circumstances of the area, the state may use that information to
identify new major stationary sources and major modifications of [that]
precursor that will not be considered to contribute significantly to
PM2.5 levels that exceed the standard in the nonattainment
area.'' As part of the current SIP submittal, the District has provided
an analysis in accordance with the requirements of 40 CFR
51.1006(a)(3).\3\
---------------------------------------------------------------------------

    \2\ See 80 FR 52236, 52242-3 (August 28, 2015), 81 FR 50339,
50341.
    \3\ Final Report: Demonstration of SO2 Precursor Contributions
to PM2.5 in the San Francisco Bay Area, Bay Area Air Quality
Management District, with technical assistance from Ramboll Environ,
November 30, 2017.
---------------------------------------------------------------------------

    The analysis used the Community Multiscale Air Quality (CMAQ) Model
and California Puff Model (CALPUFF) to model the impacts of 7 new
greenfield sources emitting 370 tpy of SO2 along with a 20%
increase of current SO2 emissions from existing sources to
determine if such increases would contribute significantly to
PM2.5 levels that exceed the standard in the area. The
District provided reasoned explanations for choosing the number, size
and location of the new sources to be modeled. For the CMAQ and CALPUFF
modeling, the maximum contribution was just under 0.6 [micro]g/m\3\ and
0.68 [micro]g/m\3\, respectively. Both of these contribution estimates
are well under the recommended insignificance threshold of 1.3
[micro]g/m\3\ contained in EPA's draft PM2.5 Precursor Demonstration
Guidance.\4\
---------------------------------------------------------------------------

    \4\ Draft PM2.5 Precursor Demonstration Guidance, EPA-454/P-16-
001, U.S. EPA OAQPS, November 17, 2016, available at https://www.epa.gov/pm-pollution/draft-pm25-precursor-demonstration-guidance.
---------------------------------------------------------------------------

    Based on the information provided in the District's submitted
analysis, EPA is proposing to approve the District's demonstration that
SO2 emissions from new and modified major SO2
sources will not contribute significantly to 24-hour PM2.5
concentrations exceeding the standard in the area. A more detailed
summary of the District's demonstration and the EPA's analysis can be
found in the docket for this action.
    Based on our approval of the District's non-significance
demonstration for SO2, we find it acceptable that Section 2-
2-412--Demonstration of NOX, POC and PM2.5 Offset
Program Equivalence, does not require an annual demonstration that an
equivalent number of SO2 offsets are required under Rule 2-
2, as would otherwise be required under a fully compliant nonattainment
NSR program. While Section 2-2-303 requires offsets for SO2
emissions (as required by state law), the District will not be required
to include any offsets provided for SO2 major sources in the
annual equivalency demonstration required by Section 2-2-412--
Demonstration of NOX, POC and PM2.5 Offset
Program Equivalence.
4. Sections 110(a)(2) and 110(l) of the Act
    We are proposing to find that Regulation 2, Rules 1, 2 and 4
satisfy the requirements of sections 110(a)(2) and 110(l) of the CAA.
These sections state that each SIP revision submitted by a State shall
be adopted by such State after reasonable notice and public hearing.
Section 110(l) also states that the Administrator shall not approve a
SIP revision if the revision would interfere with any applicable
requirement concerning attainment and reasonable further progress, or
any other CAA applicable requirement.
    With respect to the procedural requirements of CAA sections
110(a)(2) and 110(l), based on our review of the public process
documentation included in the December 14, 2017 SIP submittal package,
we find that BAAQMD has provided sufficient evidence of public notice
and opportunity for comment and public hearings prior to adoption and
submittal of these rules to the EPA.
    With respect to the substantive requirements of section 110(l), we
have determined that our approval of the BAAQMD NSR SIP submittal
represents a strengthening of BAAQMD's NSR program as compared to the
District's current SIP-approved NSR program that was last approved on
August 1, 2016, and that the revision would not interfere with any
applicable CAA requirement. Therefore we are proposing full approval of
the BAAQMD NSR SIP submittal under section 110(l) of the Act.
5. Section 193 of the Act
    Section 193 of the Act includes a savings clause which provides, in
pertinent part: ``No control requirement in effect, or required to be
adopted by an order, settlement agreement, or plan in effect before
November 15, 1990, in any area which is a nonattainment area for any
air pollutant may be modified after November 15, 1990, in any manner
unless the modification insures equivalent or greater emission
reductions of such air pollutant.''
    We have reviewed the provisions included in BAAQMD's NSR SIP
submittal and find that they would ensure equivalent or greater
emission reductions compared to the current SIP-approved NSR program.
The BACT and offset requirements of the submitted rules, which are the
primary control requirements of a NSR program, are equivalent to or
more stringent than those contained in the existing SIP-approved NSR
rules. Therefore, we can

approve the submitted NSR program under section 193 of the Act.

III. Proposed Action and Public Comment

    As authorized in section 110(k)(3) of the Act, the EPA is proposing
to fully approve the submitted rules because we believe they fulfill
all relevant requirements. In support of this proposed action, we have
concluded that our approval of the submitted rules would comply with
sections 110(a)(2), 110(l) and 193 of the Act because the amended rules
would not interfere with any applicable requirement concerning
attainment of the NAAQS in the Bay Area, and do not relax control
technology and offset requirements. If we finalize this action as
proposed, our action would be codified through revisions to 40 CFR
52.220 (Identification of plan--in part), and removal of the
conditional approval contained in 40 CFR 52.248(c).
    We will accept comments from the public on the proposed approval of
Rules 2-1, 2-2, and 2-4 for the next 30 days.

IV. Incorporation by Reference

    In this rule the EPA is proposing to include in a final EPA rule
regulatory text that includes incorporation by reference. In accordance
with requirements of 1 CFR 51.5, the EPA is proposing to incorporate by
reference the BAAQMD rules listed in Table 1 of this preamble. The EPA
has made, and will continue to make, these materials available
electronically through www.regulations.gov and in hard copy at the EPA
Region IX Office (please contact the person identified in the FOR
FURTHER INFORMATION CONTACT section of this preamble for more
information).

V. Statutory and Executive Order Reviews

    Under the Clean Air Act, the Administrator is required to 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, provided that they meet the criteria of the Clean Air Act.
Accordingly, this proposed action merely proposes to approve state law
as meeting federal requirements and does not impose additional
requirements beyond those imposed by state law. For that reason, this
proposed 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 SIP 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 Clean Air Act; and
     Does not provide the EPA with the discretionary authority
to address disproportionate human health or environmental effects with
practical, appropriate, and legally permissible methods under Executive
Order 12898 (59 FR 7629, February 16, 1994).
    In addition, 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).

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Incorporation by
reference, Intergovernmental relations, Nitrogen dioxide, Ozone,
Particulate matter, Reporting and recordkeeping requirements.

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

    Dated: February 20, 2018.
Alexis Strauss,
Acting Regional Administrator, Region IX.
[FR Doc. 2018-04112 Filed 2-28-18; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register Volume 88, Number 131 (Tuesday, July 11, 2023)]
[Proposed Rules]
[Pages 44075-44077]
[FR Doc No: 2023-14587]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2023-1410; Project Identifier MCAI-2022-01517-E]
RIN 2120-AA64

Airworthiness Directives; Rolls-Royce Deutschland Ltd & Co KG
Engines

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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

SUMMARY: The FAA proposes to supersede Airworthiness Directive (AD)
2013-26-10, which applies to certain Rolls-Royce Deutschland Ltd & Co
KG (RRD) Model RB211-524G2-19, RB211-524G3-19, RB211-524H-36, and
RB211-524H2-19 engines. AD 2013-26-10 requires a one-time reduction in
the cyclic life of certain high-pressure compressor (HPC) rotor stage 1
and stage 2 disks, and removal of disks that exceed the reduced cycle
life. Since the FAA issued AD 2013-26-10, the manufacturer has revised
the engine time limits manual (TLM), introducing new and more
restrictive instructions. This proposed AD would require revisions to
the airworthiness limitations section (ALS) of the operator's existing
approved engine maintenance or inspection program, as applicable, as
specified in a European Union Aviation Safety Agency (EASA) AD, which
is proposed for incorporation by reference (IBR). The FAA is proposing
this AD to address the unsafe condition on these products.

DATES: The FAA must receive comments on this NPRM by August 25, 2023.

ADDRESSES: You may send comments, using the procedures found in 14 CFR
11.43 and 11.45, by any of the following methods:
     Federal eRulemaking Portal: Go to regulations.gov. Follow
the instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE, Washington, DC 20590.
     Hand Delivery: Deliver to Mail address above between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays.
    AD Docket: You may examine the AD docket at regulations.gov under
Docket No. FAA-2023-1410; or in person at Docket Operations between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays. The AD
docket contains this NPRM, the mandatory continuing airworthiness
information (MCAI), any comments received, and other information. The
street address for Docket Operations is listed above.
    Material Incorporated by Reference:
     For service information identified in this NPRM, contact
EASA, Konrad-Adenauer-Ufer 3, 50668 Cologne, Germany; phone: +49 221
8999 000; email: [email protected]; website: easa.europa.eu. You may
find this material on the EASA website at ad.easa.europa.eu. It is also
available at regulations.gov under Docket No. FAA-2023-1410.
     You may view this service information at the FAA,
Airworthiness Products Section, Operational Safety Branch, 1200
District Avenue, Burlington, MA 01803. For information on the
availability of this material at the FAA, call<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Sungmo Cho, Aviation Safety Engineer,
FAA, 2200 South 216th Street, Des Moines, WA 98198; phone: (781) 238-
7241; email: [email protected].

SUPPLEMENTARY INFORMATION:

Comments Invited

    The FAA invites you to send any written relevant data, views, or
arguments about this proposal. Send your comments to an address listed
under ADDRESSES. Include ``Docket No. FAA-2023-1410; Project Identifier
MCAI-2022-01517-E'' at the beginning of your comments. The most helpful
comments reference a specific portion of the proposal, explain the
reason for any recommended change, and include supporting data. The FAA
will consider all comments received by the closing date and may amend
the proposal because of those comments.
    Except for Confidential Business Information (CBI) as described in
the following paragraph, and other information as described in 14 CFR
11.35, the FAA will post all comments received, without change, to
regulations.gov, including any personal information you provide. The
agency will also post a report summarizing each substantive verbal
contact received about this NPRM.

Confidential Business Information

    CBI is commercial or financial information that is both customarily
and actually treated as private by its owner. Under the Freedom of
Information Act (FOIA) (5 U.S.C. 552), CBI is exempt from public
disclosure. If your comments responsive to this NPRM contain commercial
or financial information that is customarily treated as private, that
you actually treat as private, and that is relevant or responsive to
this NPRM, it is important that you clearly designate the submitted
comments as CBI. Please mark each page of your submission containing
CBI as ``PROPIN.'' The FAA will treat such marked submissions as
confidential under the FOIA, and they will not be placed in the public
docket of this NPRM. Submissions containing CBI should be sent to
Sungmo Cho, Aviation Safety Engineer, FAA, 2200 South 216th Street, Des
Moines, WA 98198. Any commentary that the FAA receives which is not
specifically designated as CBI will be placed in the public docket for
this rulemaking.

Background

    The FAA issued AD 2013-26-10, Amendment 39-17719 (79 FR 1315,
January 8, 2014) (AD 2013-26-10), for all RRD Model RB211-524G2-19,
RB211-524G3-19, RB211-524H-36, and RB211-524H2-19 engines. AD 2013-26-
10 was prompted by an MCAI originated by EASA, which is the Technical
Agent for the Member States of the European Union. EASA issued

EASA AD 2013-0246, dated October 10, 2013, to correct an unsafe
condition identified as part failure and consequent release of high-
energy debris, possibly resulting in damage to the airplane.
    AD 2013-26-10 requires a one-time reduction in the cyclic life of
certain HPC stage 1 and stage 2 disks and removal of disks that exceed
the reduced cycle life from service. The agency issued AD 2013-26-10 to
prevent the failure of certain life-limited parts, which could result
in uncontained engine damage and damage to the airplane.

Actions Since AD 2013-26-10 Was Issued

    Since the FAA issued AD 2013-26-10, EASA superseded EASA AD 2013-
0246 and issued EASA AD 2022-0232, dated November 28, 2022 (EASA AD
2022-0232) (referred to after this as the MCAI). The MCAI states that
the ALS for RB211-524G/H engines, which is approved by EASA, is defined
and published in TLM T-211(524)-7RR, and that these airworthiness
limitations have been identified as mandatory for continued
airworthiness. The MCAI also states that since the original issue of
TLM T-211(524)-7RR, updated thresholds and intervals were introduced
for newly designed parts. EASA AD 2013-0246 was issued to require
implementation of the reduced cyclic life limit and replacement of HPC
stage 1 and 2 disks before exceeding their life limit. The MCAI also
states that the manufacturer published a revised engine TLM since EASA
AD 2013-0246 was issued, introducing new and more restrictive
instructions. The ALS defined in the revised engine TLM also adds RRD
Model RB211-524G2-T-19, RB211-524G3-T-19, RB211-524H-T-36, and RB211-
524H2-T-19 engines to the list of affected engines.
    You may examine the MCAI in the AD docket at regulations.gov under
Docket No. FAA-2023-1410.

Related Service Information Under 1 CFR Part 51

    The FAA reviewed EASA AD 2022-0232, which specifies instructions
for accomplishing the actions specified in the applicable TLM,
including performing maintenance tasks, replacing life-limited parts,
and revising the existing approved maintenance or inspection program,
as applicable, by incorporating the limitations, tasks, and associated
thresholds and intervals described in the TLM. This material is
reasonably available because the interested parties have access to it
through their normal course of business or by the means identified in
ADDRESSES.

FAA's Determination

    These products have been approved by the aviation authority of
another country, and are approved for operation in the United States.
Pursuant to the FAA's bilateral agreement with the State of Design
Authority, it has notified the FAA of the unsafe condition described in
the MCAI described above. The FAA is issuing this NPRM after
determining that the unsafe condition described previously is likely to
exist or develop in other products of the same type design.

Proposed AD Requirements in This NPRM

    This proposed AD would retain none of the requirements of AD 2013-
26-10. This proposed AD would require revising the existing approved
engine maintenance or inspection program, as applicable, to incorporate
new and more restrictive airworthiness limitations, which are specified
in EASA AD 2022-0232 described previously, except for any differences
identified as exceptions in the regulatory text of this AD and as
discussed under ``Differences Between this Proposed AD and the MCAI.''

Explanation of Required Compliance Information

    In the FAA's ongoing efforts to improve the efficiency of the AD
process, the FAA developed a process to use some civil aviation
authority (CAA) ADs as the primary source of information for compliance
with requirements for corresponding FAA ADs. The FAA has since
coordinated with other manufacturers and CAAs to use this process. As a
result, the FAA proposes to incorporate by reference EASA AD 2022-0232
in the FAA final rule. This proposed AD would, therefore, require
compliance with EASA AD 2022-0232 in its entirety through that
incorporation, except for any differences identified as exceptions in
the regulatory text of this proposed AD. Using common terms that are
the same as the heading of a particular section in the EASA AD does not
mean that operators need comply only with that section. For example,
where the AD requirement refers to ``all required actions within the
compliance times,'' compliance with this AD requirement is not limited
to the section titled ``Required Action(s) and Compliance Time(s)'' in
EASA AD 2022-0232. Service information required by the EASA AD for
compliance will be available at regulations.gov by searching for and
locating Docket No. FAA-2023-1410 after the FAA final rule is
published.

Difference Between This Proposed AD and the MCAI

    Where paragraph (3) of EASA AD 2022-0232 specifies revising the
approved Aircraft Maintenance Programme within 12 months after the
effective date of EASA AD 2022-0232, this proposed AD would require
revising the ALS of the existing approved engine maintenance or
inspection program, as applicable, within 90 days after the effective
date of this AD.

Costs of Compliance

    The FAA estimates that this AD, if adopted as proposed, would
affect 22 engines installed on airplanes of U.S. registry.
    The FAA estimates the following costs to comply with this proposed
AD:

                                                 Estimated Costs
----------------------------------------------------------------------------------------------------------------
                                                                                Cost per       Cost on U.S.
               Action                        Labor cost           Parts cost        product         operators
----------------------------------------------------------------------------------------------------------------
Revise the ALS of the existing        1 work-hours x $85 per               $0              $85           $1,870
 approved engine maintenance or        hour = $85.
 inspection program.
----------------------------------------------------------------------------------------------------------------

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. 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.
    The FAA is issuing this rulemaking under the authority described in

Subtitle VII, Part A, Subpart III, Section 44701: General requirements.
Under that section, Congress charges the FAA with promoting safe flight
of civil aircraft in air commerce by prescribing regulations for
practices, methods, and procedures the Administrator finds necessary
for safety in air commerce. This regulation is within the scope of that
authority because it addresses an unsafe condition that is likely to
exist or develop on products identified in this rulemaking action.

Regulatory Findings

    The FAA determined that this proposed AD would not have federalism
implications under Executive Order 13132. This proposed AD would not
have a substantial direct effect on the States, on the relationship
between the national Government and the States, or on the distribution
of power and responsibilities among the various levels of government.
    For the reasons discussed above, I certify that the proposed
regulation:
    (1) Is not a ``significant regulatory action'' under Executive
Order 12866,
    (2) Would not affect intrastate aviation in Alaska, and
    (3) Would not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.

List of Subjects in 14 CFR Part 39

    Air transportation, Aircraft, Aviation safety, Incorporation by
reference, Safety.

The Proposed Amendment

    Accordingly, under the authority delegated to me by the
Administrator, the FAA proposes to amend 14 CFR part 39 as follows:

PART 39--AIRWORTHINESS DIRECTIVES

0
1. The authority citation for part 39 continues to read as follows:

    Authority:  49 U.S.C. 106(g), 40113, 44701.

Sec.  39.13  [Amended]

0
2. The FAA amends Sec.  39.13 by:
0
a. Removing Airworthiness Directive 2013-26-10, Amendment 39-17719 (79
FR 1315, January 8, 2014); and
0
b. Adding the following new airworthiness directive:

Rolls-Royce Deutschland Ltd & Co KG: Docket No. FAA-2023-1410;
Project Identifier MCAI-2022-01517-E.

(a) Comments Due Date

    The FAA must receive comments on this airworthiness directive
(AD) by August 25, 2023.

(b) Affected ADs

    This AD replaces AD 2013-26-10, Amendment 39-17719 (79 FR 1315,
January 8, 2014).

(c) Applicability

    This AD applies to Rolls-Royce Deutschland Ltd & Co KG (RRD)
Model RB211-524G2-19, RB211-524G2-T-19, RB211-524G3-19, RB211-524G3-
T-19, RB211-524H-36, RB211-524H-T-36, RB211-524H2-19, and RB211-
524H2-T-19 engines.

(d) Subject

    Joint Aircraft System Component (JASC) Code 7230, Turbine Engine
Compressor Section.

(e) Unsafe Condition

    This AD was prompted by the manufacturer revising the engine
time limits manual, introducing new and more restrictive
instructions. The FAA is issuing this AD to prevent failure of
certain life-limited parts. The unsafe condition, if not addressed,
could result in uncontained engine damage and damage to the
airplane.

(f) Compliance

    Comply with this AD within the compliance times specified,
unless already done.

(g) Required Actions

    Except as specified in paragraph (h) of this AD: Perform all
required actions within the compliance times specified in, and in
accordance with, European Union Aviation Safety Agency (EASA) AD
2022-0232, dated November 28, 2022 (EASA AD 2022-0232).

(h) Exceptions to EASA AD 2022-0232

    (1) Where EASA AD 2022-0232 defines the AMP as the approved
Aircraft Maintenance Programme which contains the tasks on the basis
of which the scheduled maintenance is conducted to ensure the
continuing airworthiness of each operated engine, this AD defines
the AMP as the Aircraft Maintenance Program which contains the tasks
of which the operator or the owner ensures the continuing
airworthiness of each operated airplane.
    (2) Where EASA AD 2022-0232 refers to its effective date, this
AD requires using the effective date of this AD.
    (3) This AD does not require compliance with paragraph (1) of
EASA AD 2022-0232.
    (4) This AD does not require compliance with paragraph (2) of
EASA AD 2022-0232.
    (5) Where paragraph (3) of EASA AD 2022-0232 specifies revising
the approved Aircraft Maintenance Programme within 12 months after
the effective date of EASA AD 2022-0232, this AD requires revising
the airworthiness limitations section (ALS) of the existing approved
engine maintenance or inspection program, as applicable, within 90
days after the effective date of this AD.
    (6) This AD does not require compliance with paragraph (4) of
EASA AD 2022-0232.
    (7) This AD does not require compliance with paragraph (5) of
EASA AD 2022-0232.
    (8) This AD does not adopt the Remarks paragraph of EASA AD
2022-0232.

(i) Provisions for Alternative Actions and Intervals

    After performing the actions required by paragraph (g) of this
AD, no alternative actions and associated thresholds and intervals,
including life limits, are allowed unless they are approved as
specified in the provisions of the ``Ref. Publications'' section of
EASA AD 2022-0232.

(j) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, AIR-520 Continued Operational Safety Branch,
FAA, has the authority to approve AMOCs for this AD, if requested
using the procedures found in 14 CFR 39.19. In accordance with 14
CFR 39.19, send your request to your principal inspector or
responsible Flight Standards Office, as appropriate. If sending
information directly to the manager of the certification office,
send it to the attention of the person identified in paragraph (k)
of this AD and email to: [email protected].
    (2) Before using any approved AMOC, notify your appropriate
principal inspector, or lacking a principal inspector, the manager
of the local flight standards district office/certificate holding
district office.

(k) Additional Information

    For more information about this AD, contact Sungmo Cho, Aviation
Safety Engineer, FAA, 2200 South 216th Street, Des Moines, WA 98198;
phone:<PHONE_NUMBER>; email: [email protected].

(l) Material Incorporated by Reference

    (1) The Director of the Federal Register approved the
incorporation by reference (IBR) of the service information listed
in this paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.
    (2) You must use this service information as applicable to do
the actions required by this AD, unless the AD specifies otherwise.
    (i) European Union Aviation Safety Agency AD 2022-0232, dated
November 28, 2022.
    (ii) [Reserved]
    (3) For EASA AD 2022-0232, contact EASA, Konrad-Adenauer-Ufer 3,
50668 Cologne, Germany; phone: +49 221 8999 000; email:
[email protected]; website: easa.europa.eu. You may find this EASA
AD on the EASA website at ad.easa.europa.eu.
    (4) You may view this service information at FAA, Airworthiness
Products Section, Operational Safety Branch, 1200 District Avenue,
Burlington, MA 01803. For information on the availability of this
material at the FAA, call<PHONE_NUMBER>.
    (5) You may view this service information that is incorporated
by reference at the National Archives and Records Administration
(NARA). For information on the availability of this material at
NARA, email: [email protected], or go to: www.archives.gov/federal-register/cfr/ibr-locations.html.

    Issued on July 6, 2023.
Michael Linegang,
Acting Director, Compliance & Airworthiness Division, Aircraft
Certification Service.
[FR Doc. 2023-14587 Filed 7-10-23; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 88, Number 123 (Wednesday, June 28, 2023)]
[Notices]
[Pages 41952-41953]
[FR Doc No: 2023-13759]

=======================================================================
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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. CP19-14-002]

Mountain Valley Pipeline, LLC; Notice of Request for Extension of
Time

    Take notice that on June 15, 2023, Mountain Valley Pipeline, LLC
(Mountain Valley), requested that the Federal Energy Regulatory
Commission (Commission) grant an extension of time until June 18, 2026,
to complete construction of the MVP Southgate Project (Southgate
Project) and place the Southgate Project facilities into service, as
authorized in the June 18, 2020 Order Issuing Certificate (Certificate
Order),\1\ under Section 7 of The Natural Gas Act.
---------------------------------------------------------------------------

    \1\ Mountain Valley Pipeline, LLC, 171 FERC ] 61,232 (2020),
order on reh'g, 172 FERC ] 61,261 (2020), aff'd sub. nom., Sierra
Club, et al. v. FERC, 38 F.4th 220 (D.C. Cir. 2022).
---------------------------------------------------------------------------

    On June 24, 2022, Mountain Valley filed a motion requesting a four-
year extension of time, until October 13, 2026, to construct and place
into service the Mountain Valley Pipeline Project (Mainline System) and
the Greene

Interconnect.\2\ The extension of time for the Mainline System was
granted on August 23, 2022.\3\
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    \2\ Mountain Valley Pipeline, LLC, June 24, 2022 Request for
Extension of Time. The Mountain Valley Pipeline Project was
certificated in Docket No. CP16-10-000 and amended in Docket No.
CP21-477-000. The Greene Interconnect Project was authorized in
Docket No. CP19-477-000 pursuant to Mountain Valley's blanket
certificate.
    \3\ Mountain Valley Pipeline, LLC, 180 FERC ] 61,117 (2022).
---------------------------------------------------------------------------

    Mountain Valley states that construction and completion of the
Mainline System has been delayed due to persistent litigation and
resultant repetitive permitting processes. The Southgate Project has
experienced its own permitting delays, some of which is directly tied
to Mainline System permitting.\4\
---------------------------------------------------------------------------

    \4\ Mountain Valley Pipeline, LLC v. N.C. Dep't of Env't
Quality, 990 F.3d 818, 833 (4th Cir. 2021).
---------------------------------------------------------------------------

    Mountain Valley asserts that even if the Southgate Project had all
of its permits, the Mainline System permitting delays would have
prevented Mountain Valley from commencing construction of the Southgate
Project under the terms of the Certificate Order. In its request
Mountain Valley avers that the circumstances have changed because
President Biden signed legislation that will expedite the completion of
the Mainline System.\5\ Mountain Valley affirms that it is awaiting
permits from the U.S. Army Corps of Engineers and approval from the
Commission to resume full construction of the Mainline System. Mountain
Valley is targeting to complete construction and commence service on
the Mainline System by the end of 2023. After resolving Mainline System
permitting, Mountain Valley plans to resume its permitting efforts for
the Southgate Project.
---------------------------------------------------------------------------

    \5\ Fiscal Responsibility Act of 2023, H.R. 3746, 118th Cong.
Sec.  324 (2023).
---------------------------------------------------------------------------

    This notice establishes a 15-calendar day intervention and comment
period deadline. Any person wishing to comment on Mountain Valley's
request for an extension of time may do so. No reply comments or
answers will be considered. If you wish to obtain legal status by
becoming a party to the proceedings for this request, you should, on or
before the comment date stated below, file a motion to intervene in
accordance with the requirements of the Commission's Rules of Practice
and Procedure (18 CFR 385.214 or 385.211) and the Regulations under the
Natural Gas Act (18 CFR 157.10).
    As a matter of practice, the Commission itself generally acts on
requests for extensions of time to complete construction for Natural
Gas Act facilities when such requests are contested before order
issuance. For those extension requests that are contested,\6\ the
Commission will aim to issue an order acting on the request within 45
days.\7\ The Commission will address all arguments relating to whether
the applicant has demonstrated there is good cause to grant the
extension.\8\ The Commission will not consider arguments that re-
litigate the issuance of the certificate order, including whether the
Commission properly found the project to be in the public convenience
and necessity and whether the Commission's environmental analysis for
the certificate complied with the National Environmental Policy Act.\9\
At the time a pipeline requests an extension of time, orders on
certificates of public convenience and necessity are final and the
Commission will not re-litigate their issuance.\10\ The OEP Director,
or his or her designee, will act on all of those extension requests
that are uncontested.
---------------------------------------------------------------------------

    \6\ Contested proceedings are those where an intervenor disputes
any material issue of the filing. 18 CFR 385.2201(c)(1) (2022).
    \7\ Algonquin Gas Transmission, LLC, 170 FERC ] 61,144, at P 40
(2020).
    \8\ Id. at P 40.
    \9\ Similarly, the Commission will not re-litigate the issuance
of an NGA section 3 authorization, including whether a proposed
project is not inconsistent with the public interest and whether the
Commission's environmental analysis for the permit order complied
with NEPA.
    \10\ Algonquin Gas Transmission, LLC, 170 FERC ] 61,144, at P 40
(2020).
---------------------------------------------------------------------------

    In addition to publishing the full text of this document in the
Federal Register, the Commission provides all interested persons an
opportunity to view and/or print the contents of this document via the
internet through the Commission's Home Page (http://www.ferc.gov) using
the ``eLibrary'' link. Enter the docket number excluding the last three
digits in the docket number field to access the document. At this time,
the Commission has suspended access to the Commission's Public
Reference Room. For assistance, contact FERC at
[email protected] or call toll-free,<PHONE_NUMBER> or TTY,
(202) 502-8659.
    The Commission strongly encourages electronic filings of comments
in lieu of paper using the ``eFile'' link at http://www.ferc.gov. In
lieu of electronic filing, you may submit a paper copy. Submissions
sent via the U.S. Postal Service must be addressed to: Kimberly D.
Bose, Secretary, Federal Energy Regulatory Commission, 888 First Street
NE, Room 1A, Washington, DC 20426. Submissions sent via any other
carrier must be addressed to: Kimberly D. Bose, Secretary, Federal
Energy Regulatory Commission, 12225 Wilkins Avenue, Rockville, Maryland
20852.
    The Commission's Office of Public Participation (OPP) supports
meaningful public engagement and participation in Commission
proceedings. OPP can help members of the public, including landowners,
environmental justice communities, Tribal members and others, access
publicly available information and navigate Commission processes. For
public inquiries and assistance with making filings such as
interventions, comments, or requests for rehearing, the public is
encouraged to contact OPP at<PHONE_NUMBER> or [email protected].
    Comment Date: 5:00 p.m. Eastern Time on July 7, 2023.

Kimberly D. Bose,
Secretary.
[FR Doc. 2023-13759 Filed 6-27-23; 8:45 am]
BILLING CODE 6717-01-P


WQS Regulatory Revision  -  Federalism Consultation
September 2, 2010

Attendees
EPA Attendees:
Evelyn Washington
Shari Barash
Christina Christensen
Fred Leutner
Chelsea Morris
Andrew Hanson

Outside Attendees:
See attached.

Notetaker:
Clair Meehan -- Tetra Tech

Questions and Answers During Presentation

General Clarifications
Question: Will options selection occur before comments are due?
Washington: Yes -- options selection will occur in early October. Our options selection will consider any feedback we have received by that time.

Question: What kinds of things come up over and over?
Christensen: Issues related to antidegradation. The specifics are different, but we think that key changes to the regulation will make our handling of these situations more efficient. We also get many questions about the triennial review process.
Barash: "What is a standard" in a WQS submission -- this came up in Florida's IWR.

Question: When do you need comments by?
Barash: We would like to get key messages as soon as possible. There is no formal end to this public consultation process (it is not an official comment period). We have various methods for communicating with states, including WQSMA (some members are also ASIWPCA members), the WEF Forum, and the state listening sessions that were announced in the Federal Register.

Question: You have been meeting with states, but what about elected officials? Have any of the listening sessions included state and local elected officials?
Barash: This listening session is intended to serve that purpose. We also had listening sessions that were opened to the public. We did not have anything specific for elected officials.
Question: You say you have been communicating with states for 2 years, yet the last slide indicates that you want input tomorrow.
Barash: We hope to get input on this call today and receive more detailed comments in writing.  The invitation letter indicates that the period is 45 days from today. But that is almost the time of options selection.

Administrator's Determination
Question (after slides about Administrator's determination): Do you anticipate that the Administrator would have the option to issue a national water quality standard rather than an individual state standard?
Leutner: The typical practice is that we deal with individual states. We have only had a national standard when we have looked across all states and found that many did not have appropriate criteria for toxic pollutants. We issued criteria for those 14 states. That is probably our broadest case.
Washington: We are not trying to go that far. We are just trying to identify the specific communications that would be considered a determination.

Antidegradation
Question: On antidegrdation -- the current regs say that states have to identify implementation methods and you said that some have not. Is it not easier to enforce this rather than requiring a whole new EPA approval process?
Christensen: The problem with our current reg is that "identify" is a vague term. Our interpretation is that states must adopt implementation methods. We want to make it clear in the regs and say that states have to "adopt."
Barash: We have heard comments that we are going too far. There are a number of states that have identified methods that are inadequate -- they may not really support the policy. We need to make sure that states are implementing the policy.
Question: In specifying minimum elements, will you look at how this impacts state flexibility? Will it reduce flexibility?
Barash: It may in some cases. In others it will increase flexibility. We are trying to make things more transparent for the public.
Question: Any list I have seen from EPA does not include flexibility. You need to look at what the CWA says and try to keep things flexible.
Question: On a related issue, one example of where flexibility may be an issue is in how states address public comment. Each state has its own process set forth in its own regulation. If you set up minimum elements, there will be a cost associated with that. This will impact states and localities.
Christensen: We heard similar comments in the earlier listening sessions. We are developing an economic analysis of the impacts of this rule. Please provide specific comments on cost. We also want to hear any ideas of what you would like to see in the antideg minimum elements.

Highest Attainable Use
Question: How often is the provision about highest attainable use applied?
Christensen: We have some states (2-3) that have many unclassified waters. How can we get those states to go out and designate those unclassified waters as 101(a)(2) uses or do a UAA to show why those uses cannot be attained?
Barash: Some states have no subcategories of use -- they either designated aquatic life use or they do not -- and they remove the use if there is the use is not fully met. However, they might not look at what is attainable. In the same analysis showing what is not attainable, a state should show what is attainable. It should not be "all or nothing."
Question: For states with unclassified waters, have they done the analyses and found that the uses cannot be attained or have they simply not done the analyses?
Barash: Under the rebuttable presumption idea, some states have waters with no uses -- and have not done a UAA. Some states have gone through the process.
Question: How many instances do you have where a state has not gone thru the process? What about the case where there is a waterbody and the state has found that the waterbody cannot be used for aquatic life and that is as clean as they can get it? If this is done through a public process, with appropriate input, what is the problem?
Leutner: Sometimes a UAA has been done, and the state has removed the aquatic life use but has not replaced it with any more specific aquatic life use. For instance, the water cannot support trout and the state removes the entire aquatic life use, even if the water could support something more limited (e.g., a warmwater fishery). This is a case when states could consider the highest attainable use. We encourage the use of bioassessment to determine more specific uses (e.g., examine what species are there?)
Question: So a state is implementing all or nothing?
Christensen: We are not supporting a hierarchy or ranking. We are saying that there are gradations within aquatic life. We want to protect what is there.
Barash: Even if setting up gradations of uses state-wide is too difficult, states can identify what is attainable at specific sites. We have heard that EPA needs to define this concept better in the proposal.
Question: The idea of the highest use attainable makes sense to a point. How would you deal with downstream uses? It still imposes a requirement.
Question: You keep mentioning "a few states" as the basis for making this change. Is there any accumulation of the data? If it is just a few states or agencies, why are you changing standards that apply to everyone to get at a problem that is more limited?
Barash: For standards that are submitted, we are already applying these concepts. But, the ideas are not well explained. We have been approving/disapproving standards based on current practice, but EPA wants to codify things that are current practice.
Question: That should be part of the explanation.
Question: Some states are already being creative and should not be subject to additional requirements.
Barash: In this comment period, where you think a lot of states are already doing these things (or close), we want to hear about that. Please provide suggestions for how we can change our approach to consider these.

Variances
Question: Are variances commonly used?
Leutner: There are several. Some states do not want to use them because they come with a negative connotation. Putting this in regulation might make it easier for some states to use this tool.
Question: It is worthwhile to clarify variances.  But it should be based on current practices. The expiration date is ok -- legally it is well put. But you do have to look at the current knowledge, how it is used, and not be overly stringent on how it is used. This is a good one.
Barash: It would be helpful to get input on what a reasonable timeframe (e.g., maximum) would be.
Question: This is one area where you want to be flexible. You should get input during the comment period.
Barash: We will be requesting comment on this type of question. Variances are a temporary change to the use that ultimately changes the criteria. A lot of states do not want to give up on a use but want to make a temporary change or give a discharger some relief. There are expectations for progress and things like that.
Question: There are some examples where you need an extended time (e.g., mercury).

Triennial Reviews
Question: Related to scope of triennial reviews -- what if the public says that the state needs to do a full scope review? What if a state only has enough money for a targeted review?
Christensen: We might say that states need to take comment and consider those comments when it makes a decision about what to cover. It is ok if a state wants to be targeted -- there may be a good reason to look at a particular subset of waters. But states should hear what people have to say.
Question: Will you determine what the comment period should be, or will that be left up to the state? You need to be clear about what states need to do in response to the public comment.
Question: At what point do states have to do a full review?

Questions and Answers Following Conclusion of Presentation

Question: There are some good ideas. However, it looks like this is mostly about convenience for EPA. Areas D, E, and F make a lot of sense. Areas A, B, and C are stumbling blocks. There is an expectation that you have narrowed down target areas to a small group of people. EPA did not identify that areas have less administrative burden, are less costly, or are more flexibility. I encourage you to think that way. There will be more unfunded mandates. Cities cannot afford more burden.
Question: We are dealing with solid wastes, air, and other issues. Many mandates are being imposed, and we are cash-strapped. We constantly come up with issues that are not considered in cost estimates. EPA only considers what it will cost states as a regulated entity rather than what it will cost as an implementing partner.
Leutner: We are required to look at burden to co-regulators.
Question: That is not necessarily being done.
Question: For 35 years we have been submitting comments. We are saying rather than aggressively expanding priorities, we want to look back and see how we can improve what has already been expanded. Even without these rules, we are looking at $3-5 trillion in the next few years at the local level. Part is increased population and development (which are our responsibility) -- but part is related to mandates. There has to be a way to partner better.
Barash: If you think there is a list of areas where EPA can make changes in the burden and still achieve the same goals, we want to hear that. We have been trying to work with counterparts in other EPA offices.
Question: In certain states, any changes have to go through the state legislative process.
Barash: We want to look for things that can be reviewed/approved as WQS without being part of state regs. We want to see where there is flexibility.
Washington: We are struggling to address situations where people need more definitions.
Question: You also talked about records for public comment. If you are talking about a new method for us to communicate, that is a huge cost (e.g., if some new technology is required).
Question: Some entities feel like they have not had an opportunity to discuss this with EPA.
Barash: There might be other opportunities.
Comment from Moderator: We welcome comments beyond October 11. We understand that many of you have a formal process before we can submit formal comments. While October 11 is ideal, it is a soft date. If you have extensive comments in 75 days, we will still pay attention to your comments. October 11 is just the date for options selection. The rule will not be until next year. Perhaps this group might want to meet again in early 2011 to get more information.

Question: Is EPA willing to share the list of original 40 ideas?
Barash: Yes.