[Federal Register Volume 80, Number 91 (Tuesday, May 12, 2015)]
[Rules and Regulations]
[Pages 27102-27107]
[FR Doc No: 2015-11343]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R10-OAR-2014-0744; FRL-9927-45-Region 10]

Approval and Promulgation of Implementation Plans; Washington:
Infrastructure Requirements for the Fine Particulate Matter National
Ambient Air Quality Standards

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: The Environmental Protection Agency (EPA) is partially
approving and partially disapproving the State Implementation Plan
(SIP) submittal from Washington demonstrating that the SIP meets the
infrastructure requirements of the Clean Air Act (CAA) for the National
Ambient Air Quality Standards (NAAQS) promulgated for fine particulate
matter (PM2.5) on July 18, 1997, October 17, 2006, and
December 14, 2012 (collectively, the PM2.5 NAAQS). The CAA
requires that each state, after a new or revised NAAQS is promulgated,
review its SIP to ensure that it meets the infrastructure requirements
necessary to implement the new or revised NAAQS. On September 22, 2014,
Washington made a SIP submission to establish that the Washington SIP
meets the infrastructure requirements of the CAA for the
PM2.5 NAAQS, except for certain elements related to the
Prevention of Significant Deterioration (PSD) permitting program
currently addressed under a Federal Implementation Plan (FIP), certain
elements of the regional haze program currently addressed under a FIP,
and specific requirements related to interstate transport which the
State will address in a separate submittal. The EPA has determined that
Washington's SIP is adequate for purposes of the infrastructure SIP
requirements of the CAA for the PM2.5 NAAQS, with the
exceptions noted above. The SIP deficiencies related to PSD permitting
and regional haze, however, have already been adequately addressed by
the existing EPA FIPs and, therefore, no further action is required by
Washington or the EPA for those elements. The EPA will address the
remaining interstate transport requirements in a separate action.

DATES: This final rule is effective June 11, 2015.

ADDRESSES: The EPA has established a docket for this action under
Docket ID No. EPA-R10-OAR-2014-0744. All documents in the docket are
listed on the www.regulations.gov Web site. Although listed in the
index, some information is not publicly available, e.g., Confidential
Business Information (CBI) or other information the disclosure of which
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 either electronically through www.regulations.gov or in hard
copy at the Air Programs Unit, Office of Air Waste and Toxics, EPA
Region 10, 1200 Sixth Avenue, Seattle, WA 98101. The EPA requests that
if at all possible, you contact the individual listed in the FOR
FURTHER INFORMATION CONTACT section to view the hard copy of the
docket. You

may view the hard copy of the docket Monday through Friday, 8:00 a.m.
to 4:00 p.m., excluding Federal holidays.

FOR FURTHER INFORMATION CONTACT: For information please contact Jeff
Hunt at<PHONE_NUMBER><EMAIL_ADDRESS>or by using the above EPA,
Region 10 address.

SUPPLEMENTARY INFORMATION:

Definitions

    For the purpose of this document, we are giving meaning to certain
words or initials as follows:
    (i) The words or initials ``Act'' or ``CAA'' mean or refer to the
Clean Air Act, unless the context indicates otherwise.
    (ii) The words ``EPA'', ``we'', ``us'' or ``our'' mean or refer to
the United States Environmental Protection Agency.
    (iii) The initials ``SIP'' mean or refer to State Implementation
Plan.
    (iv) The words ``Washington'' and ``State'' mean the State of
Washington.

Table of Contents

I. Background Information
II. Response to Comments
III. Final Action
IV. Incorporation by Reference
V. Statutory and Executive Orders Review

I. Background Information

    On July 18, 1997, the EPA promulgated a new 24-hour and a new
annual NAAQS for PM2.5 (62 FR 38652). On October 17, 2006,
the EPA revised the standards for PM2.5, tightening the 24-
hour PM2.5 standard from 65 micrograms per cubic meter
([micro]/m\3\) to 35 [micro]/m\3\, and retaining the annual
PM2.5 standard at 15 [micro]/m\3\ (71 FR 61144).
Subsequently, on December 14, 2012, the EPA revised the level of the
health based (primary) annual PM2.5 standard to 12 [micro]/
m\3\ (78 FR 3086, published January 15, 2013).\1\
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    \1\ In the EPA's 2012 PM2.5 NAAQS revision, we left
unchanged the existing welfare (secondary) standards for
PM2.5 to address PM-related effects such as visibility
impairment, ecological effects, damage to materials and climate
impacts. This includes an annual secondary standard of 15.0 [mu]g/
m\3\ and a 24-hour standard of 35 [mu]g/m\3\.
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    States must make SIP submissions meeting the requirements of CAA
sections 110(a)(1) and (2) within three years after promulgation of a
new or revised standard. CAA sections 110(a)(1) and (2) require states
to address basic SIP requirements, including emissions inventories,
monitoring, and modeling to implement, maintain, and enforce the
standards, so-called ``infrastructure'' requirements. To help states
meet this statutory requirement, the EPA issued guidance to states. On
October 2, 2007, the EPA issued guidance to address infrastructure SIP
elements for the 1997 ozone and 1997 PM2.5 NAAQS.\2\
Subsequently, on September 25, 2009, the EPA issued guidance to address
SIP infrastructure elements for the 2006 24-hour PM2.5
NAAQS.\3\ Finally, on September 13, 2013, the EPA issued guidance to
address infrastructure SIP elements generally for all NAAQS, including
the 2012 PM2.5 NAAQS.\4\ As noted in the guidance documents,
to the extent an existing SIP already meets the applicable CAA section
110(a)(2) requirements, states may make a SIP submission to EPA
certifying how the existing SIP meets applicable requirements. On
September 22, 2014, Washington made a submittal to the EPA certifying
that the current Washington SIP meets the CAA section 110(a)(1) and (2)
infrastructure requirements for the PM2.5 NAAQS, except for
certain requirements related to PSD permitting, regional haze, and
interstate transport described in the proposal for this action (79 FR
62368, October 17, 2014).\5\
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    \2\ William T. Harnett, Director, Air Quality Policy Division,
Office of Air Quality Planning and Standards. ``Guidance on SIP
Elements Required Under Sections 110(a)(1) and (2) for the 1997 8-
hour Ozone and PM2.5 National Ambient Air Quality
Standards.'' Memorandum to EPA Air Division Directors, Regions I-X,
October 2, 2007.
    \3\ William T. Harnett, Director, Air Quality Policy Division,
Office of Air Quality Planning and Standards. ``Guidance on SIP
Elements Required Under Sections 110(a)(1) and (2) for the 2006 24-
hour Fine Particle (PM2.5) National Ambient Air Quality
Standards (NAAQS).'' Memorandum to Regional Air Division Directors,
Regions I-X, September 25, 2009.
    \4\ Stephen D. Page, Director, Office of Air Quality Planning
and Standards. ``Guidance on Infrastructure State Implementation
Plan (SIP) Elements under Clean Air Act Sections 110(a)(1) and
110(a)(2).'' Memorandum to EPA Air Division Directors, Regions 1-10,
September 13, 2013.
    \5\ Following the EPA's October 17, 2014 proposed action the CAA
section 110(a)(1) and (2) infrastructure requirements for the
PM2.5 NAAQS, the EPA subsequently proposed to partially
approve Washington's PSD permitting program while retaining a FIP
for certain facilities, emission categories, and geographic areas
(80 FR 838, January 7, 2015). The EPA's action on Washington's PSD
SIP submission does not affect the findings of this final
infrastructure action because a FIP or partial FIP for PSD continues
to remain in place.
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II. Response to Comments

    The EPA received two sets of comments on our proposal.
    Commenter #1: The commenter raised several issues related to wood
smoke. First, the commenter thanked the EPA for our involvement in
addressing wood smoke health risks in Washington State. Second, the
commenter expressed disappointment with the Washington State
Legislature for not taking seriously the toxicity and multiple health
hazards of wood smoke. Third, the commenter requested that the EPA
establish filtration controls on wood smoke emissions from restaurants
and food trucks, such as pizza and barbeque establishments. Fourth, the
commenter noted several apartment buildings in the Seattle area that
have uncertified wood burning devices and requested a date for removal
or upgrade of the existing devices.
    Response #1: The EPA appreciates the commenter's general concerns
with respect to wood smoke. However, the commenter raises issues that
are outside the scope of an action related to infrastructure SIP
requirements. In this context, the EPA is merely evaluating the State's
September 22, 2014, submission intended to establish that the
Washington SIP meets the basic infrastructure requirements of the CAA
for the PM2.5 NAAQS. In this final action, the EPA is
determining that the State has met those requirements, except for
certain elements related to the PSD and regional haze FIPs, and
specific requirements related to interstate transport which the state
will address in a separate submission. The points raised, and requests
made, by the commenter are thus not germane to this specific rulemaking
action.
    The EPA notes that there have been improvements related to wood
smoke in Washington through other substantive actions. The EPA's
involvement in addressing wood smoke health risks in SIP provisions is
driven by our CAA statutory authorities and responsibilities. Under CAA
section 109, the EPA sets NAAQS for six criteria pollutants, including
particulate matter. These NAAQS are set using the best available
scientific and health studies, with a focus on protecting sensitive
populations such as asthmatics, children, and the elderly (78 FR 3086,
January 15, 2013). Under part D of the CAA, Plan Requirements for
Nonattainment Areas, the states have an obligation to develop and
submit SIP provisions that provide for attainment and maintenance of
the NAAQS in designated nonattainment areas. The EPA has the authority
and responsibility to review this type of SIP submission to assure that
they meet applicable statutory and regulatory requirements. Through
this process, the EPA recently worked with the Washington Department of
Ecology (Ecology) and Puget Sound Clean Air Agency (PSCAA) to address
PM2.5 nonattainment in the Tacoma area (74 FR 58688,
November 13, 2009). This resulted in more stringent statutory and
regulatory provisions related to residential wood stoves at both the
local level (78 FR 32131, May 29, 2013) and the state level (79 FR
26628, May 9, 2014). Currently

all areas in Washington State are meeting the NAAQS, including the
Tacoma area (77 FR 53772, September 4, 2012).
    The commenter also requested EPA intervention in regulating wood
smoke emissions from restaurants and food trucks, such as pizza and
barbeque retail establishments. Currently the EPA has not promulgated
Federal emission limitations or control technologies specific to food
preparation at restaurants and other retail food establishments; nor is
the EPA seeking comment on this issue at this time. If necessary for
purposes of attainment and maintenance of the NAAQS, it may be
necessary for states to control emissions from such sources in SIP
provisions. However, the EPA would typically expect such actions to
occur in the context of the nonattainment plan requirements of CAA
sections 172 and 189 rather than the general infrastructure provisions
of CAA section 110. Given that all areas in Washington State are
currently attaining the PM2.5 NAAQS, however, there appears
to be no need for such regulations for these sources at this time. To
the extent that particulate matter emissions from retail food
establishments could trigger air permitting obligations, these would be
addressed under the EPA's requirements for state minor source
permitting programs under 40 CFR 51.160 through 51.164 (larger
commercial or industrial food preparation facilities could be subject
to other air permitting requirements). The EPA's minor source
permitting requirements generally give states and local authorities
discretion to regulate sources in ways that most effectively address
pollution problems in that area. In the case of PSCAA, with
jurisdiction in the Seattle area, the EPA approved minor source
permitting rules that exclude ``restaurants and other retail food-
preparing establishments'' under PSCAA Regulation I--section
6.03(b)(13).\6\ To the extent that restaurants and food trucks may
violate other regulatory provisions of the SIP, such as the EPA-
approved opacity limits of PSCAA Regulation I--section 9.03, the EPA
provides a citizen hotline for possible Federal oversight and
enforcement.\7\
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    \6\ http://yosemite.epa.gov/r10/airpage.nsf/15f53e4f3ac23a8088256b6e00039415/df888e71a7de53a388257bef0077c3b8!OpenDocument.
    \7\ http://www2.epa.gov/enforcement/report-environmental-violations.
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    Lastly, the commenter alleged that nearby Seattle apartment
buildings are using uncertified wood burning devices and requested that
a date be set for removal or upgrade of the devices. This comment is
also one that falls outside of the scope of the current action, where
the EPA is finalizing its determination that Washington's SIP satisfies
the infrastructure requirements of CAA section 110(a)(2) (A), (B),
(C)--except for those elements covered by the PSD FIP, (D)(i)(II)
(prong 4)--except for those elements covered by the regional haze FIP,
(D)(ii)--except for those elements covered by the PSD FIP, (E), (F),
(G), (H), (J)--except for those elements covered by the PSD FIP, (K),
(L), and (M). Additionally, Federal action is being taken separately to
address emissions from wood burning stoves. On March 16, 2015, the EPA
finalized updated Federal standards for residential wood burning
devices.\8\ The EPA's final rulemaking explicitly stated that it would
not ban the use of uncertified devices that are already in existing
homes. In this respect, Washington's statutes and regulations are
already more stringent than the Federal requirements. Under Washington
Administrative Code (WAC) 173-433-155 Criteria for Prohibiting Solid
Fuel Burning Devices that are not Certified, Ecology or a local clean
air agency may prohibit uncertified solid fuel burning devices in a
nonattainment area or an area with an approved PM2.5
maintenance plan, if certain criteria are met. Beginning in 2015, this
provision will apply to the Tacoma PM2.5 area as a
maintenance plan requirement.\9\ However the commenter's request to
expand the ban on uncertified solid fuel devices in other geographic
areas of the State is outside the scope of this current rulemaking
action which is limited to the consideration of the adequacy of
Washington's SIP submission with respect to the infrastructure
requirements of the CAA.
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    \8\ Standards of Performance for New Residential Wood Heaters,
New Residential Hydronic Heaters and Forced-Air Furnaces, and New
Residential Masonry Heaters (80 FR 13672, March 16, 2015).
    \9\ Approval and Promulgation of Air Quality Implementation
Plans; Washington; Redesignation to Attainment for the Tacoma-Pierce
County Nonattainment Area and Approval of Associated Maintenance
Plan for the 2006 24-Hour Fine Particulate Matter Standard (80 FR
7347, February 10, 2015).
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    Commenter #2: The commenter states that the EPA cannot approve
Washington's infrastructure SIP submission with respect to CAA section
110(a)(2)(G) because the emergency episode plan (contingency plan)
contained in WAC 173-435 does not specify a significant harm level or
action levels for PM2.5. The commenter also states that the
sampling procedures, equipment, and methods contained in the
contingency plan (WAC 173-435-070) were written with coarse particulate
(PM10) in mind and need to be updated to reflect
PM2.5. Lastly, the commenter notes that Washington's
contingency plan provisions contain no significant harm level or
updated sampling, monitoring, and equipment provisions for lead (Pb).
    Response #2: The EPA's September 2013 infrastructure guidance (2013
guidance) makes recommendations to states for how to meet the two
requirements of section 110(a)(2)(G): (the requirement to have state
emergency episode authority comparable to CAA section 303, and the
requirement to have an adequate contingency plan for the NAAQS at
issue). With respect to the first requirement, the EPA recommended that
``[t]o meet Element G requirements, the best practice for an air agency
submitting an infrastructure SIP would be to submit . . . the statutory
or regulatory provision that provides the air agency or official with
authority comparable to that of the EPA Administrator under section 303
. . . along with a narrative explanation of how they meet the
requirements of this element.'' With respect to the second requirement,
the EPA recommended that ``[t]he air agency is also required to submit,
for approval into the SIP, an adequate contingency plan to implement
the air agency's emergency episode authority. This can be met by
submitting a contingency plan that meets the applicable requirements of
40 CFR part 51, subpart H (40 CFR 51.150 through 51.153) (``Prevention
of Air Pollution Emergency Episodes'') for the relevant NAAQS if the
NAAQS is covered by those regulations.''
    The regulations at 40 CFR part 51, subpart H do not address
PM2.5 specifically and do not identify a significant harm
level or priority classification levels for PM2.5. However,
the EPA has recommended to states, through the September 25, 2009
guidance, which remains in effect and is referenced in the 2013
guidance, that states only need to develop contingency plans for any
area that has monitored and recorded 24-hour PM2.5 levels
greater than 140.4 ug/m\3\ since 2006. The EPA has evaluated
PM2.5 regulatory monitoring data in the State of Washington
since 2006 and we have confirmed that no values greater than 140.4 ug/
m\3\ have been recorded. Please see Monitoring Report in the docket for
this action.\10\ In the absence of a significant harm level and
classification levels for PM2.5 the 2013 guidance states,
``the EPA believes that the central

components of a contingency plan would be to reduce emissions from the
source(s) at issue (if necessary by curtailing operations of . . .
PM2.5 sources) and public communication as needed.'' We
believe that, based on our guidance, Washington's general regulatory
authority under WAC 173-435 and statutory authority under Revised Code
of Washington (RCW) 70.94.710 through 70.94.730, which restrain any
source from causing or contributing to an imminent and substantial
endangerment, are comparable to CAA section 303. The adequacy of these
authorities (including the sampling, equipment, and methods provision
identified by the commenter) were evaluated as part of the proposed
action, and we find that they are sufficient to meet the requirements
of CAA section 110(a)(2)(G) for the PM2.5 NAAQS.
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    \10\ 205_supporting materials_AMP 350MX 88101 WA 2006-13 14Nov14
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    We note that this action does not address CAA section 110(a)(2)(G)
for the 2008 Pb NAAQS. Accordingly, the comment regarding Pb is outside
the scope of this action. The EPA previously took final action to
approve the Washington SIP for Pb infrastructure requirements on July
23, 2014 (79 FR 42683). In that action, we relied on the EPA's guidance
that, with respect to lead, ``[i]f a state believes, based on its
inventory of lead sources and historic ambient monitoring data, that it
does not need a more specific contingency plan beyond having authority
to restrain any source from causing or contributing to an imminent and
substantial endangerment, then the state could provide such a detailed
rationale in place of a specific contingency plan.'' \11\ For
Washington, there were no facilities that emitted lead at the emissions
inventory thresholds, therefore the EPA accepted Washington's
demonstration that there was not a need for more specific contingency
planning beyond having general authority to restrain sources comparable
to CAA section 303. The EPA made this final determination on July 23,
2014, and therefore the comment on this issue is not timely for
consideration regarding the Washington Pb SIP, nor relevant to this
action which is limited in scope to the PM2.5 NAAQS. EPA is
not reopening this issue by responding to this commenter concerning the
Pb NAAQS, and is merely providing this response for informational
purposes.
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    \11\ Stephen D. Page, Director, Office of Air Quality Planning
and Standards. ``Guidance on Infrastructure State Implementation
Plan (SIP) Elements Required under Clean Air Act Sections 110(a)(1)
and 110(a)(2) for the 2008 Lead (Pb) National Ambient Air Quality
Standards (NAAQS)'' Memorandum to EPA Air Division Directors,
Regions 1-10, October 14, 2011.
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    We are finalizing our approval of the Washington SIP for purposes
of CAA section 110(a)(2)(G) for the 1997, 2006 and 2012
PM2.5 NAAQS.

III. Final Action

    The EPA is partially approving and partially disapproving the
September 22, 2014, infrastructure SIP submittal from Washington
demonstrating that the SIP meets the applicable requirements of CAA
sections 110(a)(1) and (2) for the PM2.5 NAAQS promulgated
in 1997, 2006, and 2012. Specifically, we have determined that the
current EPA-approved Washington SIP meets the following CAA section
110(a)(2) infrastructure elements for the 1997, 2006 and 2012
PM2.5 NAAQS: (A), (B), (C)--except for those elements
covered by the PSD FIP, (D)(i)(II) (prong 4)--except for those elements
covered by the regional haze FIP, (D)(ii)--except for those elements
covered by the PSD FIP, (E), (F), (G), (H), (J)--except for those
elements covered by the PSD FIP, (K), (L), and (M). We are also
finalizing our inclusion of WAC 173-400-111(3)(i) in the SIP with
respect to the CAA section 110(a)(2)(L) permit fee requirements, as
described in the proposal for this action. Also, as discussed in the
proposal for this action, the EPA anticipates that there would be no
additional consequences to Washington or to sources in the State
resulting from the partial disapproval of portions of the
infrastructure SIP submission because there are already PSD and
regional haze FIPs in place to address those infrastructure SIP
requirements. The EPA likewise anticipates no additional FIP
responsibilities for PSD and regional haze as a result of this partial
disapproval. Interstate transport requirements with respect to CAA
section 110(a)(2)(D)(i)(I) for the 2006 and 2012 PM2.5 NAAQS
will be addressed in a separate action.

IV. Incorporation by Reference

    As discussed in the proposal for this action, the State requested
that the EPA revise our incorporation by reference of WAC 173-400-
111(3)(i) in the SIP to include the text that ``[a]ll fees required
under chapter 173-455 WAC (or the applicable new source review fee
table of the local air pollution control authority) have been paid.''
This minor change to the incorporation by reference of the SIP was made
to ensure that all infrastructure requirements under CAA section
110(a)(2)(L) are met. In accordance with requirements of 1 CFR 51.5,
the EPA is finalizing the incorporation by reference of the Washington
Department of Ecology regulations contained in WAC 173-400-111. The EPA
has made, and will continue to make, these documents generally
available electronically through www.regulations.gov and/or in hard
copy at the appropriate EPA office (see the ADDRESSES section of this
preamble for more information).

V. Statutory and Executive Orders Review

    Under the CAA, the Administrator is required to approve a SIP
submission that complies with the provisions of the Act and applicable
Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in
reviewing SIP submissions, the EPA's role is to approve State choices,
provided that they meet the criteria of the Clean Air Act. Accordingly,
this action merely approves State law as meeting Federal requirements
and does not impose additional requirements beyond those imposed by
State law. For that reason, this action:
     Is not a ``significant regulatory action'' subject to
review by the Office of Management and Budget under Executive Order
12866 (58 FR 51735, October 4, 1993);
     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 this action does not involve technical standards; and
     does not provide the EPA with the discretionary authority
to address, as appropriate, disproportionate human health or
environmental effects, using practicable and legally permissible
methods, under Executive Order 12898 (59 FR 7629, February 16, 1994).

    The SIP is not approved to apply on any Indian reservation land in
Washington except as specifically noted below and is also not approved
to apply 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 as specified by
Executive Order 13175 (65 FR 67249, November 9, 2000), nor will it
impose substantial direct costs on tribal governments or preempt tribal
law. Washington's SIP is approved to apply on non-trust land within the
exterior boundaries of the Puyallup Indian Reservation, also known as
the 1873 Survey Area. Under the Puyallup Tribe of Indians Settlement
Act of 1989, 25 U.S.C. 1773, Congress explicitly provided state and
local agencies in Washington authority over activities on non-trust
lands within the 1873 Survey Area. Consistent with EPA policy, the EPA
provided a consultation opportunity to the Puyallup Tribe in a letter
dated September 3, 2013. The EPA did not receive a request for
consultation.
    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 CAA, petitions for judicial review
of this action must be filed in the United States Court of Appeals for
the appropriate circuit by July 13, 2015. 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 in 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.

    Dated: April 28, 2015.
Dennis J. McLerran,
Regional Administrator, Region 10.

    For the reasons set forth in the preamble, 40 CFR part 52 is
amended as follows:

PART 52--APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS

0
1. The authority citation for Part 52 continues to read as follows:

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

Subpart WW--Washington

0
2. Section 52.2470 is amended by:
0
a. In Table 2--Additional Regulations Approved for Washington
Department of Ecology (Ecology) Direct Jurisdiction, revising paragraph
(c) entry 173-400-111;
0
b. In Table 2--Attainment, Maintenance, and Other Plans for ``110(a)(2)
Infrastructure Requirements--1997, 2006, and 2012 Fine Particulate
Matter (PM2.5) Standards'', adding to paragraph (e) an entry
at the end of the section with the undesignated center heading
``110(a)(2) Infrastructure and Interstate Transport.''
    The revision and addition read as follows:

Sec.  52.2470  Identification of plan.

* * * * *
    (c) * * *

   Table 2--Additional Regulations Approved for Washington Department of Ecology (Ecology) Direct Jurisdiction
 [Applicable in Adams, Asotin, Chelan, Columbia, Douglas, Ferry, Franklin, Garfield, Grant, Kittitas, Klickitat,
   Lincoln, Okanogan, Pend Oreille, San Juan, Stevens, Walla Walla, and Whitman counties, excluding facilities
 subject to Energy Facilities Site Evaluation Council (EFSEC) jurisdiction, Indian reservations (excluding non-
 trust land within the exterior boundaries of the Puyallup Indian Reservation), and any other area where the EPA
  or an Indian tribe has demonstrated that a tribe has jurisdiction. These regulations also apply statewide for
 facilities subject to the applicability sections of WAC 173-400-700, WAC 173-405-012, WAC 173-410-012, and WAC
                                                  173-415-012]
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                                                               State
         State citation                 Title/subject        effective    EPA approval date      Explanations
                                                                date
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         Washington Administrative Code, Chapter 173-400--General Regulations for Air Pollution Sources
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173-400-111.....................  Processing Notice of         12/29/12  5/12/15 [Insert      Except: 173-400-
                                   Construction                           Federal Register     111(3)(h); The
                                   Applications for                       citation].           part of 173-400-
                                   Sources, Stationary                                         111(8)(a)(v) that
                                   Sources and Portable                                        says,
                                   Sources.                                                    ``and 173-460-
                                                                                040,''; 173-400-
                                                                                111(9).

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

* * * * *
    (e) * * *

                                Table 2--Attainment, Maintenance, and Other Plans
----------------------------------------------------------------------------------------------------------------
                                                               State
      Name of SIP provision       Applicable geographic or   submittal    EPA approval date        Comments
                                     nonattainment area         date
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------
                                110(a)(2) Infrastructure and Interstate Transport
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
110(a)(2) Infrastructure          Statewide...............      9/22/14  5/12/15 [Insert      This action
 Requirements--1997, 2006, and                                            Federal Register     addresses the
 2012 Fine Particulate Matter                                             citation].           following CAA
 (PM2.5) Standards.                                                                            elements:
                                                                                110(a)(2)(A),
                                                                                (B), (C),
                                                                                (D)(i)(II),
                                                                                (D)(ii), (E),
                                                                                (F), (G), (H),
                                                                                (J), (K), (L),
                                                                                and (M).
----------------------------------------------------------------------------------------------------------------

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

* * * * *
[FR Doc. 2015-11343 Filed 5-11-15; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 84, Number 130 (Monday, July 8, 2019)]
[Proposed Rules]
[Pages 32363-32365]
[FR Doc No: 2019-14245]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 62

[EPA-R09-OAR-2019-0344; FRL-9995-98-Region 9]

Approval and Promulgation of State Plans for Designated
Facilities and Pollutants; Arizona; Control of Emissions From Existing
Municipal Solid Waste Landfills

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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

SUMMARY: The Environmental Protection Agency (EPA) is proposing to
approve a state plan submitted by the State of Arizona. This state plan
submittal pertains to the regulation of landfill gas and its
components, including methane, from existing municipal solid waste
(MSW) landfills. Arizona's state plan was submitted in response to the
EPA's promulgation of Emissions Guidelines and Compliance Times for MSW
landfills. This action is being taken under the Clean Air Act (CAA).

DATES: Written comments must be received on or before August 7, 2019.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-R09-
OAR-2019-03440344 at http://www.regulations.gov, or via email to
<EMAIL_ADDRESS>For comments submitted at Regulations.gov, follow
the online instructions for submitting comments. Once submitted,
comments cannot be edited or removed 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: Jeffrey Buss, U.S. EPA Region IX,
(415) 947-4152<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    On August 29, 2016, the EPA finalized Standards of Performance for
Municipal Solid Waste Landfills and Emission Guidelines and Compliance
Times for Municipal Solid Waste Landfills in 40 CFR part 60 subpart XXX
and Cf, respectively. 81 FR 59332 and 81 FR 59276. These actions were
taken under section 111 of the CAA.
    Section 111(d) of the CAA requires the EPA to establish a procedure
for a state to submit a plan to the EPA which establishes standards of
performance for any air pollutant: (1) For which air quality criteria
have not been issued or which is not included on a list published under
CAA section 108 or emitted from a source category which is regulated
under CAA section 112 but (2) to which a standard of performance under
CAA section 111 would apply if such existing source were a new source.
The EPA established the requirements for state plan submittals in 40
CFR part 60, subpart B. State submittals under CAA sections 111(d) must
be consistent with the relevant emission guidelines, in this instance
40 CFR part 60, subpart Cf, and the requirements of 40 CFR part 60,
subpart B.
    On July 24, 2018, the Arizona Department of Environmental Quality
(ADEQ) submitted to the EPA a formal section 111(d) plan for existing
municipal solid waste landfills. The submitted section 111(d) plan was
in response to the August 29, 2016 promulgation of federal NSPS and
emission guidelines requirements for MSW landfills, 40 CFR part 60,
subparts XXX and Cf, respectively (81 FR 59332 and 81 FR 59276) 76 FR
15372).

II. Summary of the Plan and EPA Analysis

    The EPA has reviewed the Arizona section 111(d) plan submittal in
the context of the requirements of 40 CFR part 60, subparts B and Cf,
and part 62, subpart A. In this action, the EPA is proposing to
determine that the submitted section 111(d) plan meets the above-cited
requirements. The primary mechanism selected by ADEQ to implement the
emission guidelines for MSW landfills under state jurisdiction is
through incorporation by reference of 40 CFR part 60, subpart Cf and 40
CFR part 60, subpart XXX into the Arizona Administrative Code (A.A.C.),
at A.A.C. R18-2-731, entitled ``Standards of Performance for Existing
Municipal Solid Waste Landfills,'' and A.A.C. R18-2-901(79), entitled
``New Source Performance Standards,'' on July 6, 2018. These subparts
will be applicable to MSW landfills under the plan upon the EPA's
approval of the plan by final rulemaking. A detailed explanation of the
rationale behind this proposed approval is available in the Technical
Support Document (TSD).

III. Proposed Action

    The EPA is proposing to approve the Arizona section 111(d) plan for
MSW landfills submitted pursuant to 40 CFR part 60, subpart Cf.
Therefore, the EPA is proposing to amend 40 CFR part 62, subpart D, to
reflect this action. This approval is based on the rationale previously
discussed and in further detail in the TSD associated with this action.
The scope of the proposed approval of the section 111(d) plan is
limited to the provisions of 40 CFR parts 60 and 62 for existing MSW
landfills, as referenced in the emission guidelines, subpart Cf.

IV. Incorporation by Reference

    In this document, the EPA is proposing to include in a final EPA
rule regulatory text that includes incorporation by reference of the
state plan. In accordance with requirements of 1 CFR 51.5, the EPA is
proposing to incorporate by reference ADEQ rules regarding MSW
landfills discussed in section II of this preamble. The EPA has made,
and will continue to make, these materials generally available through
http://www.regulations.gov, Docket ID No. EPA-R09-OAR-2019-0344, and 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

    In reviewing state plan submissions, the 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 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 this action is not significant 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 (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 the 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).
    In addition, this proposed approval of Arizona's state plan
submittal for existing MSW landfills does not have tribal implications
as specified by Executive Order 13175 (65 FR 67249, November 9, 2000),
because the state plan is not approved to apply in Indian country
located in the state, and the

EPA notes that it will not impose substantial direct costs on tribal
governments or preempt tribal law.

List of Subjects in 40 CFR Part 62

    Environmental protection, Air pollution control, Landfills,
Incorporation by reference, Intergovernmental relations, Methane,
Ozone, Reporting and recordkeeping requirements, Sulfur oxides,
Volatile organic compounds.

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

    Dated: June 20, 2019.
Deborah Jordan,
Acting Regional Administrator, Region IX.
[FR Doc. 2019-14245 Filed 7-5-19; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register Volume 83, Number 55 (Wednesday, March 21, 2018)]
[Notices]
[Pages 12383-12384]
[FR Doc No: 2018-05754]

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

ENVIRONMENTAL PROTECTION AGENCY

[FRL-9975-80-OA]

Request for Nominations of Candidates to the Clean Air Scientific
Advisory Committee (CASAC)

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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

SUMMARY: The U.S. Environmental Protection Agency (EPA) invites
nominations of scientific experts from a diverse range of disciplines
to be considered for appointment to the Clean Air Scientific Advisory
Committee (CASAC).

DATES: Nominations should be submitted in time to arrive no later than
April 20, 2018.

FOR FURTHER INFORMATION CONTACT: For all inquiries, nominators should
contact Mr. Aaron Yeow, Designated Federal Officer (DFO) for the CASAC,
EPA Science Advisory Board Staff Office (1400R), 1200 Pennsylvania
Ave., NW, Washington DC 20460; by telephone at<PHONE_NUMBER> or by email
at [email protected]. Anyone unable to submit electronic nominations
may send a paper copy to Mr. Yeow.

SUPPLEMENTARY INFORMATION:
    Background: The CASAC is a chartered Federal Advisory Committee,
established pursuant to the Clean Air Act (CAA) Amendments of 1977,
codified at 42 U.S.C. 7409(d)(2), to provide advice, information and
recommendations to the EPA Administrator on the scientific and
technical aspects of air quality criteria and National Ambient Air
Quality Standards (NAAQS). Members of the CASAC constitute a
distinguished body of non-EPA scientists and engineers who are
nationally and internationally recognized experts in their respective
fields. Members are appointed by the EPA Administrator for a three-year
term and serve as Special Government Employees who provide independent
expert advice to the agency.
    Expertise sought for CASAC: The CASAC was established pursuant to
the Clean Air Act (CAA) Amendments of 1977, codified at 42 U.S.C.
7409(d)(2), to review air quality criteria and NAAQS

and recommend to the EPA Administrator any new NAAQS and revisions of
existing criteria and NAAQS as may be appropriate. The CASAC shall
also: advise the EPA Administrator of areas in which additional
knowledge is required to appraise the adequacy and basis of existing,
new, or revised NAAQS; describe the research efforts necessary to
provide the required information; advise the EPA Administrator on the
relative contribution to air pollution concentrations of natural as
well as anthropogenic activity; and advise the EPA Administrator of any
adverse public health, welfare, social, economic, or energy effects
which may result from various strategies for attainment and maintenance
of such NAAQS. As required under the CAA section 109(d), the CASAC is
composed of seven members, with at least one member of the National
Academy of Sciences, one physician, and one person representing state
air pollution control agencies. The SAB Staff Office is seeking
nominations of experts to serve on the CASAC with expertise in: Air
quality, biostatistics, ecology, environmental economics, environmental
engineering, epidemiology, exposure assessment, medicine, risk
assessment, and toxicology. The SAB Staff Office is especially
interested in scientists with expertise described above who have
knowledge and experience relating to criteria pollutants (carbon
monoxide, lead, nitrogen oxides, ozone, particulate matter, and sulfur
oxides). For further information about the CASAC membership appointment
process and schedule, please contact Mr. Aaron Yeow, DFO, by telephone
at<PHONE_NUMBER> or by email at [email protected],gov.

Selection Criteria for the CASAC

    Nominees are selected based on their individual qualifications.
Curriculum vitae should reflect the following:

--Demonstrated scientific credentials and disciplinary expertise in
relevant fields;
--Willingness to commit time to the committee and demonstrated ability
to work constructively and effectively on committees; and
--Background and experiences that would help members contribute to the
diversity of perspectives on the committee, e.g., geographical,
economic, social, cultural, educational backgrounds, professional
affiliations; and other considerations.
--For the committee as a whole, consideration of the collective breadth
and depth of scientific expertise; and a balance of scientific
perspectives is important.

As the committee undertakes specific advisory activities, the SAB Staff
Office will consider two additional criteria for each new activity:
absence of financial conflicts of interest and absence of an appearance
of a loss of impartiality.
    How to submit nominations: Any interested person or organization
may nominate qualified persons to be considered for appointment to this
advisory committee. Individuals may self-nominate. Nominations should
be submitted in electronic format (preferred) using the online
nomination form under ``Public Input on Membership'' on the CASAC web
page at http://www.epa.gov/casac. To be considered, all nominations
should include the information requested below. EPA values and welcomes
diversity. All qualified candidates are encouraged to apply regardless
of sex, race, disability or ethnicity.
    The following information should be provided on the nomination
form: contact information for the person making the nomination; contact
information for the nominee; the disciplinary and specific areas of
expertise of the nominee; the nominee's curriculum vitae; and a
biographical sketch of the nominee indicating current position,
educational background; research activities; sources of research
funding for the last two years; and recent service on other national
advisory committees or national professional organizations. To help the
agency evaluate the effectiveness of its outreach efforts, please
indicate how you learned of this nomination opportunity. Persons having
questions about the nomination process or the public comment process
described below, or who are unable to submit nominations through the
CASAC website, should contact the DFO, as identified above. The DFO
will acknowledge receipt of nominations and will invite the nominee to
provide any additional information that the nominee feels would be
useful in considering the nomination, such as availability to
participate as a member of the committee; how the nominee's background,
skills and experience would contribute to the diversity of the
committee; and any questions the nominee has regarding membership. The
names and biosketches of qualified nominees identified by respondents
to this Federal Register notice, and additional experts identified by
the SAB Staff Office, will be posted in a List of Candidates on the
CASAC website at http://www.epa.gov/casac.
    Public comments on each List of Candidates will be accepted for 21
days from the date the list is posted. The public will be requested to
provide relevant information or other documentation on nominees that
the SAB Staff Office should consider in evaluating candidates.
    Candidates may be asked to submit the ``Confidential Financial
Disclosure Form for Special Government Employees Serving on Federal
Advisory Committees at the U.S. Environmental Protection Agency'' (EPA
Form 3110-48). This confidential form is required for Special
Government Employees (SGEs) and allows EPA to determine whether there
is a statutory conflict between that person's public responsibilities
as an SGE and private interests and activities, or the appearance of a
loss of impartiality, as defined by Federal regulation. The form may be
viewed and downloaded through the ``Ethics Requirements for Advisors''
link on the CASAC home page at http://www.epa.gov/casac. This form
should not be submitted as part of a nomination.

    Dated: March 13, 2018.
 Khanna Johnston,
Deputy Director, EPA Science Advisory Staff Office.
[FR Doc. 2018-05754 Filed 3-20-18; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register Volume 88, Number 113 (Tuesday, June 13, 2023)]
[Rules and Regulations]
[Pages 38387-38391]
[FR Doc No: 2023-12442]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2022-1055; Project Identifier AD-2022-00573-T;
Amendment 39-22455; AD 2023-11-09]
RIN 2120-AA64

Airworthiness Directives; Gulfstream Aerospace Corporation
Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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

SUMMARY: The FAA is adopting a new airworthiness directive (AD) for
certain Gulfstream Aerospace Corporation Model GVII-G500 and GVII-G600
airplanes. This AD was prompted by reports of two landing incidents in
which the alpha limiter engaged in the landing flare in unstable air,
resulting in high rate of descent landings and damage to the airplanes.
This AD requires updating the flight control computer (FCC) software.
The FAA is issuing this AD to address the unsafe condition on these
products.

DATES: This AD is effective July 18, 2023.
    The Director of the Federal Register approved the incorporation by
reference of certain publications listed in this AD as of July 18,
2023.

ADDRESSES:
    AD Docket: You may examine the AD docket at regulations.gov under
Docket No. FAA-2022-1055; 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 final rule, any comments received, and other
information. The address for Docket Operations is U.S. Department of
Transportation, Docket Operations, M-30, West Building Ground Floor,
Room W12-140, 1200

New Jersey Avenue SE, Washington, DC 20590.
    Material Incorporated by Reference:
     For service information identified in this final rule,
contact Gulfstream Aerospace Corporation, Technical Publications Dept.,
P.O. Box 2206, Savannah, GA 31402-2206; telephone<PHONE_NUMBER>; email
[email protected]; website gulfstream.com/en/customer-support.
     You may view this service information at the FAA,
Airworthiness Products Section, Operational Safety Branch, 2200 South
216th St., Des Moines, WA. For information on the availability of this
material at the FAA, call<PHONE_NUMBER>. It is also available at
regulations.gov under Docket No. FAA-2022-1055.

FOR FURTHER INFORMATION CONTACT: Myles Jalalian, Aviation Safety
Engineer, FAA, 1701 Columbia Avenue, College Park, GA 30337; phone:
404-474-5572; email: [email protected].

SUPPLEMENTARY INFORMATION:

Background

    The FAA issued a notice of proposed rulemaking (NPRM) to amend 14
CFR part 39 by adding an AD that would apply to certain Gulfstream
Aerospace Corporation Model GVII-G500 and GVII-G600 airplanes. The NPRM
published in the Federal Register on September 8, 2022 (87 FR 54925).
The NPRM was prompted by reports of two landing incidents in which the
alpha limiter engaged in the landing flare in unstable air, resulting
in high rate of descent landings and damage to the airplane. In the
NPRM, the FAA proposed to require updating the FCC software. The FAA is
issuing this AD to address inappropriate alpha limiter engagement
during the landing flare, which can limit pilot pitch authority during
a critical phase of flight near the ground, and result in a high rate
of descent landing with possible consequent loss of control of the
airplane.

Discussion of Final Airworthiness Directive

Comments

    The FAA received comments from two commenters, Disney Aviation
Group (Disney) and Gulfstream Aerospace Corporation (Gulfstream). The
following presents the comments received on the NPRM and the FAA's
response to each comment.

Request To Add Service Information

    Disney noted that the proposed AD does not reference Gulfstream
Technical Bulletins Aircraft Service Change (ASC) No. 039A (for GVII-
G500) or ASC No. 029A (for GVII-G600). Disney suggested referring to
those documents, rather than requiring using a method approved by the
FAA, would be logical and easy. Gulfstream added that these ASCs
provide corrective actions to address the unsafe condition and should
be incorporated by reference in the proposed AD. Gulfstream added that
including the ASCs would provide a less ambiguous path to AD compliance
and alleviate the need for operators to obtain an alternative method of
compliance (AMOC).
    The FAA agrees. Gulfstream GVII-G500 ASC No. 039, Revision A, dated
September 13, 2022, including Thales Service Bulletin C13204J-27-002,
Revision 01, dated September 13, 2022, and Thales Service Bulletin
C13212J-27-002, Revision 01, dated September 13, 2022; and Gulfstream
GVII-G600 ASC No. 029, Revision A, dated September 12, 2022, including
Thales Service Bulletin C13204K-27-002, Revision 01, dated September
13, 2022, and Thales Service Bulletin C13212K-27-002, Revision 01,
dated September 13, 2022; which provide procedures for updating the FCC
software, were not available when the NPRM was issued. However, the FAA
has now reviewed this service information and determined that it
addresses the unsafe condition. The FAA has revised paragraph (g) of
this AD to include updating the FCC software in accordance with the
service information as an optional method of compliance. The FAA has
also revised this AD to add paragraph (i) of this AD to specify that
this AD does not require reporting, added paragraph (j) of this AD to
provide credit for certain previous versions of the service
information, and redesignated subsequent paragraphs accordingly.

Request To Terminate Additional AD

    Disney stated that paragraph (h) of the proposed AD, which states
that accomplishing the software update terminates all requirements of
AD 2022-10-05, Amendment 39-22043 (87 FR 27494, May 9, 2022) (AD 2022-
10-05), is not true. The commenter suggested that the software update
would terminate the requirements of both AD 2020-02-18, Amendment 39-
21026 (85 FR 8153, February 13, 2020) (AD 2020-02-18) and AD 2022-10-
05.
    The FAA agrees. Accomplishing the software update required by
paragraph (g) of this AD on an airplane terminates all requirements of
AD 2020-02-18 and AD 2022-10-05, for that airplane only. The FAA has
revised the terminating action language in paragraph (h) of this AD to
also refer to AD 2020-02-18. The FAA also revised paragraph (b) of this
AD to refer to AD 2020-02-18 as an affected AD. The FAA notes that this
AD does not supersede AD 2020-02-18 and AD 2022-10-05 because airplanes
that are operated without the FCC software update required by this AD
will continue to be subject to the operating restrictions in AD 2020-
02-18 and AD 2022-10-05.

Request Change to Applicability

    Gulfstream commented that FCC software version 9.5 or equivalent
will be installed in production on GVII-G500 aircraft with serial
numbers (S/Ns) 72112 and subsequent, and GVII-G600 aircraft with S/Ns
73107 and subsequent. The commenter requested that the FAA revise
paragraph (c) to specify that this AD ``applies to Gulfstream Aerospace
Corporation Model GVII-G500 airplanes, certificated in any category,
serial numbers 72001-72111 and GVII-G600 airplanes, certificated in any
category, serial numbers 73001-73106.''
    Gulfstream also commented that airplanes on which the software has
already been updated to the version required by the proposed AD should
be excluded from the applicability of proposed AD.
    The FAA partially agrees. The FAA has revised paragraph (c) of this
AD to include terminating serial numbers to exclude production
airplanes that have FCC software version 9.5 or equivalent. Regarding
the request to exclude airplanes on which the software has already been
updated, the FAA notes that this change is unnecessary. Paragraph (f)
of this AD mandates compliance with the required actions, unless
already done. Therefore, if the actions required by this AD have
already been accomplished on an airplane, that airplane is already in
compliance with this AD.

Request To Correct Software Revision Level and Part Number

    Both Disney and Gulfstream noted a typographical error in the FCC
software level identified in figure 1 to paragraph (c) of the proposed
AD. They requested the FAA revise the FCC software level for the GVII-
G600 Module B identified in figure 1 to paragraph (c) of the proposed
AD from ``72P2700001Z200-SW6.3,'' to ``72P2700001Z200-SW8.1.''
    Disney also stated the part number changes referenced in Gulfstream
ASC No. 039A and ASC No. 029A, paragraph D, Re-identified Parts, are
different from the part numbers referenced in figure 1 to paragraph (c)
of the proposed AD.

    The FAA agrees to correct the typographical error and has revised
figure 1 to paragraph (c) of this AD as requested. Regarding the
different part numbers, the FAA notes that the part numbers referenced
in figure 1 to paragraph (c) of this AD are the existing part numbers
that need to be revised.

Request To Withdraw the NPRM

    Disney stated that there is 100 percent U.S. fleet participation in
FCC software version 9.5, and they suggested that all of the
requirements have been satisfied via FAA AMOCs. The commenter did not
believe that this AD action is necessary, and the FAA infers the
commenter is requesting that the FAA withdraw the NPRM.
    The FAA disagrees. The worldwide fleet does not have 100 percent
compliance with the proposed AD; there are still airplanes that have
not been updated to FCC software version 9.5. The FAA, as the State of
Design civil aviation authority, has an obligation under international
bilateral agreements to issue an AD if an unsafe condition exists.
Further, under 14 CFR 39.7 and 39.9, there is a continuing obligation
by operators to not reintroduce the unsafe condition mandated by an AD.
Therefore, the FAA has determined this AD is necessary to address the
unsafe condition.

Request To Clarify Action in a Note

    Disney stated that note 1 to paragraph (c) of the proposed AD
suggests that removing the covers of the FCC module is necessary to
verify the software label. The commenter questioned why the software
update cannot be verified by referring to the log entry for the ASC
update.
    The FAA agrees to clarify. Note 1 to paragraph (c) of this AD is
informational in nature and does not require verification of the
software update using any particular method. Operators may use other
means to determine which software revision they have, provided they can
conclusively determine the software revision. The FAA has not changed
this AD regarding this issue.

Additional Changes Made to This Final Rule

    Since the NPRM published, the FAA evaluated the compliance time and
determined that extending the compliance time from ``no later than
April 30, 2023,'' to ``within 90 days after the effective date of this
AD,'' will not adversely affect safety. The FAA has revised the
compliance time in paragraph (g) of this AD accordingly.

Conclusion

    The FAA reviewed the relevant data, considered any comments
received, and determined that air safety requires adopting this AD as
proposed. Accordingly, the FAA is issuing this AD to address the unsafe
condition on these products. Except for minor editorial changes, and
any other changes described previously, this AD is adopted as proposed
in the NPRM. None of the changes will increase the economic burden on
any operator.

Related Service Information Under 1 CFR Part 51

    The FAA reviewed Gulfstream GVII-G500 ASC No. 039, Revision A,
dated September 13, 2022, including Thales Service Bulletin C13204J-27-
002, Revision 01, dated September 13, 2022, and Thales Service Bulletin
C13212J-27-002, Revision 01, dated September 13, 2022; and Gulfstream
GVII-G600 ASC No. 029, Revision A, dated September 13, 2022, including
Thales Service Bulletin C13204K-27-002, Revision 01, dated September
13, 2022, and Thales Service Bulletin C13212K-27-002, Revision 01,
dated September 13, 2022. This service information specifies procedures
for updating the FCC software (which includes loading new software to
the FCC modules, re-identifying each module with a new part number, and
conducting return-to-service functional checks post-modification).
These documents are distinct since they apply to different airplane
models. This service information is reasonably available because the
interested parties have access to it through their normal course of
business or by the means identified in ADDRESSES.

Costs of Compliance

    The FAA estimates that this AD affects 120 airplanes of U.S.
registry. The FAA estimates the following costs to comply with this AD:

                                                 Estimated Costs
----------------------------------------------------------------------------------------------------------------
                                                                                Cost per       Cost on U.S.
               Action                        Labor cost           Parts cost        product         operators
----------------------------------------------------------------------------------------------------------------
Software update.....................  6 work-hours x $85 per               $0             $510          $61,200
                                       hour = $510.
----------------------------------------------------------------------------------------------------------------

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

    This AD will not have federalism implications under Executive Order
13132. This AD will 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 this AD:
    (1) Is not a ``significant regulatory action'' under Executive
Order 12866,
    (2) Will not affect intrastate aviation in Alaska, and
    (3) Will 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 Amendment

    Accordingly, under the authority delegated to me by the
Administrator, the FAA amends 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 adding the following new airworthiness
directive:

2023-11-09 Gulfstream Aerospace Corporation: Amendment 39-22455;
Docket No. FAA-2022-1055; Project Identifier AD-2022-00573-T.

(a) Effective Date

    This airworthiness directive (AD) is effective July 18, 2023.

(b) Affected ADs

    This AD affects AD 2020-02-18, Amendment 39-21026 (85 FR 8153,
February 13, 2020) (AD 2020-02-18); and AD 2022-10-05, Amendment 39-
22043 (87 FR 27494, May 9, 2022) (AD 2022-10-05).

(c) Applicability

    This AD applies to Gulfstream Aerospace Corporation Model GVII-
G500 airplanes having serial numbers (S/Ns) 72001 through 72111
inclusive; and GVII-G600 airplanes having S/Ns 73001 through 73106
inclusive; certificated in any category, with flight control
computer (FCC) software revisions installed as specified in figure 1
to paragraph (c) of this AD.

                      Figure 1 to Paragraph (c) of This AD--FCC Software Revision Installed
----------------------------------------------------------------------------------------------------------------
                                                              Gulfstream Aerospace
               Model                      Nomenclature        Corporation part No.            Thales P/N
                                                                      (P/N)
----------------------------------------------------------------------------------------------------------------
GVII-G500 airplanes................  FCC COM-MON Module A..  72P2700001Z100-SW6.3..  C13204JB01
                                     FCC COM-MON Module B..  72P2700001Z200-SW6.3..  C13212JB01
GVII-G600 airplanes................  FCC COM-MON Module A..  72P2700001Z100-SW8.1..  C13204KB01
                                     FCC COM-MON Module B..  72P2700001Z200-SW8.1..  C13212KB01
----------------------------------------------------------------------------------------------------------------

    Note 1 to paragraph (c): The FCC software label, which
identifies the software revision installed, can be found on the face
of the FCC module. The FCC modules are installed within the left and
right electronic equipment racks. The labels may be viewed by
opening the rack doors and removing 4 screws per FCC (8 screws total
per airplane) from the FCC cover.

(d) Subject

    Air Transport Association (ATA) of America Code 27, Flight
controls.

(e) Unsafe Condition

    This AD was prompted by reports of two landing incidents where
the alpha limiter engaged in the landing flare in unstable air while
on the approach and caused high rate of descent landings and damage
to the airplane. The FAA is issuing this AD to address inappropriate
alpha limiter engagement during the landing flare, which can limit
pilot pitch authority during a critical phase of flight near the
ground, and result in a high rate of descent landing with possible
consequent loss of control of the airplane.

(f) Compliance

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

(g) Software Update

    Within 90 days after the effective date of this AD, update the
FCC software in accordance with either:
    (1) Gulfstream GVII-G500 Aircraft Service Change No. 039,
Revision A, dated September 13, 2022, including Thales Service
Bulletin C13204J-27-002, Revision 01, dated September 13, 2022, and
Thales Service Bulletin C13212J-27-002, Revision 01, dated September
13, 2022; or Gulfstream GVII-G600 Aircraft Service Change No. 029,
Revision A, dated September 13, 2022, including Thales Service
Bulletin C13204K-27-002, Revision 01, dated September 13, 2022, and
Thales Service Bulletin C13212K-27-002, Revision 01, dated September
13, 2022; as applicable; or
    (2) A method approved by the Manager, East Certification Branch,
FAA.

(h) Terminating Action for AD 2020-02-18 and AD 2022-10-05

    Accomplishing the software update required by paragraph (g) of
this AD on an airplane terminates all requirements of AD 2020-02-18
and AD 2022-10-05, for that airplane only.

(i) No Reporting Requirement

    Although Gulfstream GVII-G500 Aircraft Service Change No. 039,
Revision A, dated September 13, 2022, including Thales Service
Bulletin C13204J-27-002, Revision 01, dated September 13, 2022, and
Thales Service Bulletin C13212J-27-002, Revision 01, dated September
13, 2022; and Gulfstream GVII-G600 Aircraft Service Change No. 029,
Revision A, dated September 13, 2022, including Thales Service
Bulletin C13204K-27-002, Revision 01, dated September 13, 2022, and
Thales Service Bulletin C13212K-27-002, Revision 01, dated September
13, 2022; specify to submit certain information to the manufacturer,
this AD does not include that requirement.

(j) Credit for Previous Actions

    (1) This paragraph provides credit for the actions specified in
paragraph (g)(1) of this AD, if those actions were performed before
the effective date of this AD using Gulfstream GVII-G500 Aircraft
Service Change No. 039, dated September 12, 2022, including Thales
Service Bulletin C13204J-27-002, dated September 9, 2022, and Thales
Service Bulletin C13212J-27-002, dated September 9, 2022.
    (2) This paragraph provides credit for the actions specified in
paragraph (g)(1) of this AD, if those actions were performed before
the effective date of this AD using Gulfstream GVII-G600 Aircraft
Service Change No. 029, dated September 12, 2022, including Thales
Service Bulletin C13204K-27-002, dated September 9, 2022, and Thales
Service Bulletin C13212K-27-002, dated September 9, 2022.

(k) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, East Certification 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 (l)(1) of this AD.
    (2) Before using any approved AMOC, notify your appropriate
principal inspector, or lacking a principal inspector, the manager
of the responsible Flight Standards Office.

(l) Related Information

    (1) For more information about this AD, contact Myles Jalalian,
Aviation Safety Engineer, FAA, 1701 Columbia Avenue, College Park,
GA 30337; phone:<PHONE_NUMBER>; email: [email protected].
    (2) Service information identified in this AD that is not
incorporated by reference is available at the addresses specified in
paragraphs (m)(3) and (4) of this AD.

(m) 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) Gulfstream GVII-G500 Aircraft Service Change No. 039,
Revision A, dated September 13, 2022, including Thales Service
Bulletin C13204J-27-002, Revision 01, dated September 13, 2022, and
Thales Service Bulletin C13212J-27-002, Revision 01, dated September
13, 2022.

    (ii) Gulfstream GVII-G600 Aircraft Service Change No. 029,
Revision A, dated September 13, 2022, including Thales Service
Bulletin C13204K-27-002, Revision 01, dated September 13, 2022, and
Thales Service Bulletin C13212K-27-002, Revision 01, dated September
13, 2022.
    (3) For service information identified in this AD, contact
Gulfstream Aerospace Corporation, Technical Publications Dept., P.O.
Box 2206, Savannah, GA 31402-2206; telephone<PHONE_NUMBER>; email
[email protected]; website gulfstream.com/en/customer-support.
    (4) You may view this service information at the FAA,
Airworthiness Products Section, Operational Safety Branch, 2200
South 216th St., Des Moines, WA. 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 protected], or go to: www.archives.gov/federal-register/cfr/ibr-locations.html.

    Issued on June 2, 2023.
Michael Linegang,
Acting Director, Compliance & Airworthiness Division, Aircraft
Certification Service.
[FR Doc. 2023-12442 Filed 6-12-23; 8:45 am]
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[Federal Register Volume 82, Number 208 (Monday, October 30, 2017)]
[Notices]
[Pages 50134-50135]
[FR Doc No: 2017-23517]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-D-1264]

Manufacturers Sharing Patient-Specific Information From Medical
Devices With Patients Upon Request; Guidance for Industry and Food and
Drug Administration Staff; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of the guidance entitled ``Manufacturers Sharing
Patient-Specific Information from Medical Devices with Patients Upon
Request.'' FDA developed this guidance to clarify our position
regarding manufacturers appropriately and responsibly sharing
``patient-specific information''--information unique to an individual
patient or unique to that patient's treatment or diagnosis that has
been recorded, stored, processed, retrieved, and/or derived from a
legally marketed medical device--with that patient at that patient's
request. This guidance provides information and recommendations to
industry, health care providers, and FDA staff about the mechanisms and
considerations for device manufacturers sharing such information with
individual patients when they request it.

DATES: The announcement of the guidance is published in the Federal
Register on October 30, 2017.

ADDRESSES: You may submit either electronic or written comments on
Agency guidances at any time as follows:

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2016-D-1264 for ``Manufacturers Sharing Patient-Specific
Information from Medical Devices with Patients Upon Request.'' Received
comments will be placed in the docket and, except for those submitted
as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday.
     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.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    An electronic copy of the guidance document is available for
download from the internet. See the SUPPLEMENTARY INFORMATION section
for information on electronic access to the guidance. Submit written
requests for a single hard copy of the guidance document entitled
``Manufacturers Sharing Patient-Specific Information from Medical
Devices with Patients Upon Request'' to the Office of the Center
Director, Guidance and Policy Development, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 5431, Silver Spring, MD 20993-0002. Send one self-
addressed adhesive label to assist that office in processing your
request.

FOR FURTHER INFORMATION CONTACT: Esther Bleicher, Center for Devices
and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, Rm. 5424, Silver Spring, MD 20993-0002, 301-
796-8547.

SUPPLEMENTARY INFORMATION:

I. Background

    Increasingly, patients seek to play an active role in their own
health care. FDA believes that sharing ``patient-specific information''
with patients upon their request may assist them in being more engaged
with their health care providers in making sound medical decisions. For
purposes of this guidance, ``patient-specific information'' is
information unique to an individual

patient or unique to that patient's treatment or diagnosis that has
been recorded, stored, processed, retrieved, and/or derived from a
legally marketed medical device. This information may include, but is
not limited to, recorded patient data, device usage/output statistics,
health care provider inputs, incidence of alarms, and/or records of
device malfunctions or failures.
    FDA developed this guidance to convey FDA's position regarding
manufacturers appropriately and responsibly sharing patient-specific
information with that patient at that patient's request. In general,
manufacturers may do so without undergoing additional premarket review
in advance. FDA generally would not consider patient-specific
information to be ``labeling,'' as defined in section 201(m) of the
Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 321(m)).
FDA is aware that when manufacturers share patient-specific information
with patients, manufacturers also may provide them with supplemental
information or other materials (e.g., descriptions of intended use,
benefit and risk information, instructions for use) that may be
considered labeling. Any labeling is subject to applicable requirements
in the FD&C Act and FDA regulations.
    In the Federal Register of June 10, 2016 (81 FR 37603), FDA
announced the availability of the draft guidance formerly entitled
``Dissemination of Patient-Specific Information from Devices by Device
Manufacturers'' and interested parties were invited to comment by
August 9, 2016. FDA has considered all of the public comments received
prior to finalizing this guidance.

II. Significance of Guidance

    This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
current thinking of FDA on ``Manufacturers Sharing Patient-Specific
Information from Medical Devices with Patients Upon Request.'' It does
not establish any rights for any person and is not binding on FDA or
the public. You can use an alternative approach if it satisfies the
requirements of the applicable statutes and regulations. This guidance
is not subject to Executive Order 12866.

III. Electronic Access

    Persons interested in obtaining a copy of the guidance may do so by
downloading an electronic copy from the internet. A search capability
for all Center for Devices and Radiological Health guidance documents
is available at https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. Guidance
documents are also available at https://www.regulations.gov. Persons
unable to download an electronic copy of ``Manufacturers Sharing
Patient-Specific Information from Medical Devices with Patients Upon
Request'' may send an email request to [email protected] to
receive an electronic copy of the document. Please use the document
number 1500067 to identify the guidance you are requesting.

    Dated: October 24, 2017.
Lauren Silvis,
Chief of Staff.
[FR Doc. 2017-23517 Filed 10-27-17; 8:45 am]
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