[Federal Register Volume 85, Number 11 (Thursday, January 16, 2020)]
[Rules and Regulations]
[Pages 2648-2654]
[FR Doc No: 2020-00286]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R06-OAR-2018-0177; FRL-10003-44-Region 6]

Air Plan Approval; New Mexico; City of Albuquerque-Bernalillo
County; New Source Review (NSR) Preconstruction Permitting Program

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: Pursuant to the Clean Air Act (CAA or the Act), the
Environmental Protection Agency (EPA) is approving revisions to the
applicable New Source Review (NSR) State Implementation Plan (SIP) for
the City of Albuquerque-Bernalillo County submitted on January 18,
2018, that includes supplemental information provided on April 30,
2019. The EPA is approving newly adopted Minor New Source Review (MNSR)
permitting regulations which waive specific permitting requirements for
certain sources and create new procedures for authorizing construction
and modification of these sources.

DATES: This rule is effective on February 18, 2020.

ADDRESSES: The EPA has established a docket for this action under
Docket ID No. EPA-R06-OAR-2018-0177. All documents in the docket are
listed on the http://www.regulations.gov website. Although listed in
the index, some information is not publicly available, e.g.,
Confidential Business Information or other information whose disclosure
is restricted by statute. Certain other material, such as copyrighted
material, is not placed on the internet and will be publicly available
only in hard copy form. Publicly available docket materials are
available either electronically through http://www.regulations.gov or
in hard copy at the EPA Region 6 Office, 1201 Elm Street, Dallas, Texas
75270.

FOR FURTHER INFORMATION CONTACT: Rick Barrett, EPA Region 6 Office, Air
Permits Section, 1201 Elm Street, Dallas, TX 75270,<PHONE_NUMBER>,
<EMAIL_ADDRESS>To inspect the hard copy materials, please
schedule an appointment with Rick Barrett or Mr. Bill Deese at 214-665-
7253.

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

I. Background

    The background for this action is discussed in detail in our June
5, 2019 proposal (84 FR 26057). In that document we proposed to approve
revisions to the City of Albuquerque-Bernalillo County SIP submitted on
January 18, 2018, including supplemental information provided on April
30, 2019. The revisions addressed in our proposal included newly
adopted Minor New Source Review (MNSR) permitting regulations which
waive specific permitting requirements for certain sources and create
new procedures for authorizing construction and modification of these
sources. The revisions created procedures which allow owners and
operators of eligible gasoline dispensing facilities (GDF), and
emergency stationary reciprocating

internal combustion engines (ES-RICE), to apply for an Air Quality
Notification (AQN) rather than a construction permit. The SIP action
proposes no change in emission levels or controls, and will not result
in an increase of emissions or ambient concentration of any compounds.
    We received comments on the proposal from several commenters. The
full text of the comment letters received during the public comment
period, which closed on July 5, 2019, is included in the publicly
posted docket associated with this action at www.regulations.gov. The
EPA provides a summary of the comments received and corresponding
responses below.\1\
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    \1\ Note that comments are grouped together into categories to
assist the reader.
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II. Responses to Comments

    Comment: Several commenters stated that before any decision is made
on the proposal, the City of Albuquerque Environmental Health
Department (EHD) should come to their communities and give the
residents of Albuquerque and Unincorporated Bernalillo County,
neighborhood associations, coalitions, and interested persons an
opportunity to learn about the proposal, participate in a discussion,
get questions answered, and express concerns in a public meeting forum
in English and Spanish.
    They further stated that the EHD did not notify the residents of
Albuquerque and Unincorporated Bernalillo County of their proposal; did
not conduct any public meetings with neighborhood associations,
coalitions or the public; and did not post on their website their
proposal to EPA to approve revisions to the applicable New Source
Review (NSR) State Implementation Plan (SIP) for the City of
Albuquerque-Bernalillo County.
    Response: EPA regulations require that states must provide the
public with notice of plans or plan revisions, opportunity to submit
written comments, and either automatically hold a public hearing on the
proposed plan or revision or provide the public with the opportunity to
request such a public hearing. See 40 CFR 51.102. Notice should include
making the proposed plan or revision available for public inspection in
at least one location in each region to which it will apply. See 40 CFR
51.102(d)(2). A notice of public hearing to consider the EHD Petition
for rulemaking was published on September 26, 2017, in the New Mexico
Register and in the Albuquerque Journal on the same day. See Attachment
C, 4. Pleadings filed with Air Board. The notice met all the applicable
Federal regulations. It solicited written comments and contained the
date, place, and time of the hearing. The notice also stated that the
public could obtain the reasoning for EHD's proposed rulemaking, the
rulemaking record of the EHD, and drafts of the proposed regulatory
changes on EHD's website.\2\ Additionally, the notice, which was
published in the New Mexico Register and the Albuquerque Journal,
provided a link to the agenda for the hearing. As noted in the public
notices published in the two local newspapers, on November 8, 2017, a
public hearing was held in accordance with State and local law and the
applicable public hearing requirements. EHD considered all the comments
it received and discussed these in its hearing testimony. Public
comments were made via letters, emails and in testimony prior to, and
during, the November 8, 2017, hearing. See Attachment C, 2. Public
Comment, and Attachment C, 4. Pleadings filed with Air Board.
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    \2\ See http://www.cabq.gov/airquality/air-quality-control-board, at the link entitled ``Library of current Rulemaking
Petitions and all related documents.''
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    Furthermore, on May 30, 2017, before the formal public notification
discussed above, EHD sent copies of a draft of the proposed regulations
to Albuquerque and Bernalillo County neighborhood associations; persons
holding air quality permits for GDF or ES-RICE; and members of the
community on the email list-serve of the Air Board.\3\ EHD's cover
letter invited these stakeholders to two public comment meetings held
on June 28, 2017, one held in the afternoon and one in the evening.
Four people attended the afternoon meeting. No one attended the evening
meeting.\4\ EHD received four written comments on its draft
regulations. An announcement of the petition filing was distributed by
email to the list-serve of the Air Board on August 29, 2017. This early
engagement is not required by the EPA rules.
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    \3\ See Attachment C, 4. Pleadings filed with Air Board.
    \4\ See Attachment C, 4. Pleadings filed with Air Board.
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    Under these circumstances we do not agree with the commenters'
assertion that EHD did not notify the residents of Albuquerque and
Unincorporated Bernalillo County of their proposal, and we do not agree
that we should not approve the plan revisions for a purported lack of
adequate notice or opportunity to comment.
    Comment: Several commenters stated that they want EPA to disapprove
the SIP revision because it does not respect the basic human rights of
residents of Albuquerque to be treated with fairness, decency, and
respect, nor their basic right to due process in the decision-making
that affects their communities. They requested that EPA remand the
proposed regulations back to Albuquerque-Bernalillo County Air Quality
Control Board to amend its request in order to address public
participation, public health, the locating of multiple source emitters
close to each other, and address appeal rights.
    Additionally, several commenters stated that public participation
should not be considered a burden and expressed concern about the long
term physical and emotional health effects of the proposal, especially
for the more vulnerable members of the population--the elderly and
children. Commenters claimed that EPA's position is that since
Albuquerque is in compliance with the National Ambient Air Quality
Standards (NAAQS), public participation in Minor New Source Review
process is not necessary, stating that such rationale is not respectful
of the community living in this area that is subjected to the worst air
quality in the city and does not take into consideration environmental
justice principles. They further allege that both EPA and EHD failed to
take public health into consideration, and as a consequence, the public
will be affected by emergency room visit costs, and long-term health
implications that affect school and work attendance.
    Response: The comments that pertain to public participation have
been addressed in a response above. In short, the EPA does not agree
that there was a failure to comply with the public notice and comment-
related provisions of the Act or the relevant EPA regulations and does
not agree that the revisions should be disapproved because of the
comments relating to an asserted lack of public participation.
Regarding the commenters' other requests that EPA deny or remand the
EHD's SIP revision, EPA is required to approve a SIP revision if it
meets all the applicable Federal requirements. See CAA 110(k)(3). As
noted in our proposal, in addition to the preconstruction permitting
program requirements of CAA section 110(a)(2)(C) and 40 CFR 51.160
through 51.164, our evaluation must ensure that the proposed plan
revisions comply with section 110(l) of the CAA, which states that the
EPA shall not approve a revision of the SIP if it would interfere with
any applicable requirement concerning attainment of the NAAQS,
reasonable further progress, or any other applicable requirement of the
Act. Thus,

under CAA section 110(l), the proposed MNSR SIP revision must not
interfere with attainment, reasonable further progress, or any other
applicable requirement of the Act. The commenters misstate and
oversimplify EPA's position. It is not our position that public
participation in the Minor New Source Review process is not necessary
because Albuquerque is in compliance with the NAAQS. EPA's statutory
responsibilities in reviewing a SIP are to ensure it meets all the
applicable requirements of the Act and the corresponding Federal
regulations. CAA section 110(a)(2)(C) requires regulation of the
modification or construction of any stationary source within the areas
covered by the SIP as necessary to assure that the NAAQS are achieved.
The minor NSR regulations found at 40 CFR 51.160 through 51.164 specify
the legally enforceable procedures and requirements which are
applicable to state minor NSR programs. Federal regulations allow
states to identify the types and sizes of facilities, buildings,
structures, or installations which will be subject to review under the
minor NSR program. See 40 CFR 51.160(e). To determine whether a
specific source type can be exempted from complying with a state's
approved minor NSR program, EPA must examine whether the state has
provided an adequate basis that the exempt emissions do not need to be
reviewed to ensure attainment and maintenance of the NAAQS in the
particular geographic areas covered by the program because they are
inconsequential to attainment or maintenance, considering the
particular air quality concerns in such areas. See 40 CFE 51.160(a) and
(e) and CAA section 110(l). Additionally, our evaluation must ensure
that the submittal complies with section 110(l) of the CAA before it
can be approved into the SIP.
    Similar to the exemptions provided for in EPA's Tribal NSR Rule,
EHD seeks to exempt a small percentage of the total emissions emitted
within its jurisdiction from minor NSR review. EPA estimates that GDFs
are responsible for only 0.28% of the total emissions of volatile
organic compounds (VOC) in Albuquerque-Bernalillo County. This
percentage is not anticipated to change with the approval of the SIP
revision. VOC emissions from GDF and ES-RICE are federally regulated by
the National Emissions Standards for Hazardous Air Pollutants (NESHAP)
for GDF found in 40 CFR part 63, subpart CCCCCC; and by the NESHAP for
ES-RICE found in 40 CFR part 63, subpart ZZZZ. State regulatory
requirements for GDF and ES-RICE emissions of VOC are found at State
regulation 20.11.65 NMAC--Volatile Organic Compounds. These Federal and
State regulations impose emission limitations, management practices,
and testing and monitoring requirements in order to demonstrate
compliance with those requirements.
    For GDF with throughput of more than 100,000 gallons per month, the
applicable Federal regulation (40 CFR part 63, subpart CCCCCC) reduces
emissions by about 90% by requiring the use of Stage I vapor control.
While smaller GDF are not required by Federal regulations to use Stage
I vapor control, the Air Board's regulations (20.11.65 NMAC--Volatile
Organic Compounds) requires most GDF with underground storage tanks
larger than 3000 gallons to have Stage I vapor control. This captures
many of the GDF with throughputs below 100,000 gallons per month. As a
result, between Federal and local regulations, most GDF have pollution
controls that reduce their emissions by about 90%. The only ones that
do not have these controls are the very small GDF (typically small
fleet owners) with low throughput and associated limited potential to
emit pollutants which are hazardous to human health and wellbeing.
    Regarding ES-RICE, the pollutants which are emitted from ES-RICE
and may be relevant to NAAQS attainment are: ozone, NO2, PM,
CO and SO2. There are approximately 445 ES-RICEs in the
County, and the applicable regulations only permit them to operate
during emergencies, other than the few hours which are necessary each
year to test and maintain the engines. See Attachment C, 4. Pleadings
filed with Air Board. Because these emergency generators operate very
few hours a year, their emissions are very low. When applying EHD's
actual emission inventory estimates of 24 hours per year of operation,
each ES-RICE will only emit about 0.26 tons per year (tpy) of combined
pollutants.\5\
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    \5\ When using an assumed maximum of 500 hours of operation per
year for each ES-RICE, EPA has previously concluded that a 500 hours
per year limit would result in combined pollutant (NO2,
PM, CO and SO2) emissions of 5.5 tons per year or less
from each ES-RICE. See 78 FR 15296 (March 11, 2013).
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    Emissions from these source categories are low enough that it is
unlikely that such emissions would have a meaningful impact on
continued NAAQS attainment. Moreover, the SIP revisions do not change
or eliminate any of the controls required by NESHAP, and the approval
of these SIP revisions does not obviate the need for GDF and ES-RICE
sources to comply with all applicable NESHAP requirements--including
emissions limitations. See Attachment C, 4. Pleadings filed with Air
Board.
    Concerning the public health considerations mentioned by the
commenters, EPA was required by the CAA to promulgate NAAQS for
pollutants which are considered harmful to public health. The CAA
identifies two types of NAAQS--primary and secondary. The primary
standards provide public health protection, including the protection of
sensitive populations such as asthmatics, children, and the elderly.
All areas within EHD's jurisdiction are currently in attainment for all
NAAQS. See Attachment C, 4. Pleadings filed with Air Board, and 82 FR
29421 (June 29, 2017). The approval of this SIP revision will not cause
any degradation of air quality, and EHD was legally obligated to
demonstrate this fact to the EPA. Appendix V to 40 CFR part 51 requires
that EHD submit to the EPA a demonstration that will show
noninterference with the attainment of the NAAQS under Section 110(1)
of the Clean Air Act. The Section 110(l) demonstration submitted to EPA
showed that there will be no degradation of air quality and that
Bernalillo County will continue its attainment status of the NAAQS to
protect public health. See our proposal, 84 FR 26057, section III.C.
    In their SIP submittal, EHD presented NAAQS monitoring data for
each pollutant emitted by GDF and ES-RICE showing the concentration of
each in the ambient air in the County compared to the relevant Federal
standard. The data show the County area has been in attainment for all
the NAAQS for at least the past ten years and has not been in violation
of any NAAQS since 1996. The County has maintained attainment for the
NAAQS the entire time during which Federal NESHAP emission requirements
for these source categories have been in effect. EHD's proposal will
not change those requirements, and thus, would not result in an
increase in emissions. Review of the EHD NAAQS monitoring data showed
that concentrations of most pollutants have trended downward or
remained steady over at least the last ten years. These trends support
that the air quality is improving overall in the County. See our
proposal, 84 FR 26057, section III. C., and Attachment C, 4. Pleadings
filed with Air Board. Therefore, we find that EHD's proposal will not
interfere with attainment of any NAAQS. See Attachment C, 4. Pleadings
filed with Air Board.

    Based on these historical trends and supporting air quality
monitoring data documenting air quality improvements throughout the
State, we believe the proposed Minor NSR SIP revision meets the
requirements of CAA section 110(l), and that the implementation of
these rules will not interfere with any applicable requirement
concerning attainment, reasonable further progress, maintaining PSD
increment, or any other applicable requirement of the CAA.
    Although qualifying GDFs and ES-RICEs will now be exempt from the
Minor NSR program, EHD will post on its website all Air Quality
Notifications (AQN) issued during the previous month and all those
issued that are currently active. See <IP_ADDRESS> NMAC. This
information will include the name and location of each facility. It
will also include information enabling members of the public to contact
EHD about any AQN it has issued. Thus, the public will have access to
the information for any GDF or ES-RICE that EHD has issued an AQN.
Comments regarding the locating of multiple source emitters close to
each other are addressed in the last response below.
    Comment: Commenters stated that this proposed change is the latest
effort to hinder public participation and further stated that perhaps
informing the public, diligent review, and doing the job that taxpayers
have paid staff at the Albuquerque Environmental Health Department to
do is too burdensome.
    Response: As discussed, above, in response to other comments, the
EPA is required to approve SIP revisions that meet all applicable
requirements, and the EPA has determined that these revisions meet such
requirements. As also discussed, above, the EPA has determined that the
submission reflects satisfaction of the public participation-related
provisions of the Act and EPA's relevant regulations. In any event,
regarding the comments which stated that the EHD approved the rule in
order to relieve its administrative burden, EHD indicated that their
proposed regulations are needed to allow EHD permitting staff to focus
on permitting of larger sources with more significant air quality
impacts, for which the applicable regulatory scheme provides more
discretion and requires more technical judgment than the regulations
that apply to GDF and ES-RICE. EHD also stated that the process
associated with GDF permits has caused significant opportunity costs
for the EHD that are not justified based on the amount of emissions
produced by GDF. See Attachment C, 4. Pleadings filed with Air Board.
    The EHD explained that GDF and ES-RICE represent a minimal
potential contribution of pollutants to local air quality compared to
emissions from other sources. Their experience has shown that a
majority of permitting staff time has been devoted to managing the
process required by existing Part 41 (11-20-41) for permit applications
for these less significant contributors. EHD said that about 80% of
their permit staff resources are spent in permitting these two source
categories and devoting the majority of an air quality agency's
permitting resources to sources with minimal impact on air quality is
not a wise use of resources. EHD has determined that this imbalance in
resource allocation does not serve the public interest because it
distracts EHD from a focus on larger facilities with more potential to
impact air quality, and, as explained above, EPA is required to approve
all SIP revisions that meet the applicable requirements.
    Comment: Some commenters stated that the proposed rule does not
require air dispersion modeling, referring to a statement in EHD's
proposal that ``the department shall not require any part 39 source to
submit air dispersion modeling with its AQN application''.
    Response: As noted, above, in response to other comments, VOC
emissions from GDF and ES-RICE are inconsequential. Neither GDF nor ES-
RICE require air quality dispersion modeling. GDFs emit VOCs in
quantities which do not require modeling because their VOC emissions
are less than the EHD minor NSR threshold level of 10 lbs/hr or 25 tpy.
Their VOC emissions are modeled county-wide as an ozone component to
determine whether they are in compliance with the ozone NAAQS.
    ES-RICEs do not require modeling because of their infrequent and
unpredictable hours of operation. Air quality dispersion modeling is
done to predict the impact of expected emissions. The operation of an
emergency generator is inherently unpredictable because it operates
only during emergencies except for the few hours an engine must be
operated periodically to maintain the engine's functionality. Thus, the
necessary input to a model (the expected emissions) cannot be
accurately provided to the modeler. Thus, modeling is not useful for
emergency engine operation.
    Recently, the EHD entered into a new contract with Sonoma
Technology, Inc. (STI) to prepare the Albuquerque/Bernalillo County
Ground-Level Ozone Photochemical Modeling and Analysis. This modeling
study will emphasize ozone source contribution analysis to: Identify
source contributions from mobile, industrial/stationary sources, and
biogenic emissions; evaluate transport (international, interstate, and
intrastate) versus local emissions contributions; evaluate events
versus local emissions contributions to ozone; conduct VOC/NOx
sensitivity analysis of ozone levels in Albuquerque-Bernalillo; and
address other scenarios. This updated modeling will give EHD the most
recent scientific analysis based on the most recent air quality
information with which to determine what control strategies, if any,
might be appropriate to protect Albuquerque-Bernalillo County
attainment with the new 2015 ozone standard.
    Comment: One commenter stated that they oppose approval of the SIP
revision submitted by the EHD which waives permitting requirements for
GDF because the EHD did not provide adequate justification for its
request in 2017. The commenter alleges that EPA mischaracterizes the
NAAQS ozone data as trending downward when the values appear to
fluctuate. The commenter further stated that it is possible that the
ozone data for 2017 and 2018 would show increases, with levels
exhibiting a cyclic pattern and the same could be said for nitrogen
dioxide. The commenter stated that there have been at least two years
of particulate matter (PM10) violations within the last 10
years, and that the most recent (2016) finding for sulphur dioxide
shows a secondary violation. Further, the commenter claimed that the
EPA staff recommendation for approval is not supported by adequate
evidence.
    Response: We do not agree with the commenter that the EHD did not
provide adequate justification for its proposal request. As explained
above, in order to determine whether a specific source type can be
exempted from complying with a state's approved minor NSR program, EPA
must examine whether the state has provided an adequate basis that the
exempt emissions do not need to be reviewed to ensure attainment and
maintenance of the NAAQS in the particular geographic areas covered by
the program because they are inconsequential to attainment or
maintenance, considering the particular air quality concerns in such
areas. GDF and ES-RICE make up 62.2% of the 1088 authorized stationary
sources in Albuquerque-Bernalillo County. See Attachment C, 4.
Pleadings filed with Air Board. As we noted in our proposed approval,
the only pollutants emitted from GDFs are VOC. The VOC emitted from
GDFs account for only about 0.28% of the VOC in the entire County. Each
ES-RICE only emits about

0.26 tpy of VOC, NO2, PM, CO and SO2 combined.
Therefore, these sources generate emissions that are inconsequential to
the area's ability to attain the NAAQS.
    As noted, above, in response to other comments, a majority of EHD
permitting staff time is spent on permits for GDF and ES-RICE although,
relatively, they contribute very little to overall air pollution, and
EHD determined that devoting most of its time to sources that have an
inconsequential impact on air quality is not an effective use of public
resources. See Attachment C, 4. Pleadings filed with Air Board.
Further, GDF or ES-RICE which are located at a major source, or at a
facility which requires an air quality construction permit because of
other activities, would not be eligible for an AQN.
    The SIP revision imposes the same air quality control requirements
on GDF and ES-RICE as is currently applied through issuance of
individualized permits and contains compliance mechanisms to assure
that enforcement actions can be brought against owners or operators of
these sources which receive an AQN. See Attachment C, 4. Pleadings
filed with Air Board. EHD's proposal will improve EHD's permitting
process by allowing it to dedicate more time to its larger and more
complex air quality sources where more discretion and technical
judgment are required. EHD's proposal does not result in any changes to
the existing substantive air quality requirements for GDF and ES-RICE
that are governed by NESHAP. See Attachment C, 4. Pleadings filed with
Air Board. As explained in a response above, the SIP revision meets all
Federal requirements for minor new source review and the requirements
of section 110(l) of the Clean Air Act.
    We disagree that we mischaracterized the NAAQS ozone data. As we
discussed in our proposed approval, compliance with the 8-hour ozone
standard has improved county-wide with ozone pollutant concentrations
trending downward since the late 1980's. See EPA's Air Quality System
(AQS) database. As shown on Table 1 in the proposal, the ozone
concentration has declined overall from 0.073 ppm in 2006 to 0.065 ppm
in 2016. See our proposal, 84 FR 26057, section III.C., page 26060.
Further, local ambient ozone levels have been in decline since the
2010-2012 design value assessment period, and ozone concentrations
since 2006 have remained below the Federal standard in effect at the
time. EPA has amended the ozone NAAQS over time, lowering the
concentration necessary for attainment. In 1997, EPA set the
concentration at 0.084 parts per million. In 2008, EPA changed this to
0.075 parts per million. In 2015, EPA changed it again to 0.070 parts
per million. Albuquerque and Bernalillo County have remained in
continuous compliance with each new standard promulgated by EPA, and
continue to be in compliance for 2017 and 2018. See https://www.epa.gov/air-trends/air-quality-design-values.
    With regard to Nitrogen Dioxide (NO2) levels, compliance
with the 1-Year NO2 and 1-hour NO2 standards has
improved county-wide with NO2 pollutant concentrations
trending downward since the late 1990's. The NO2 levels have
remained relatively stable for the last decade overall for both the 1-
hour and annual standards. As shown on Table 2 in the proposal, the
NO2 concentration has declined overall from 15.4 parts per
billion (ppb) in 2006 to 10.4 ppb in 2016. At no time in that period
have levels exceeded either the 1-hour or annual standard. Rather,
levels have consistently remained well below the ambient air
concentrations specified by the standard of 53 ppb. Furthermore,
ambient NO2 levels have been in decline since the 2011-2012
design value assessment period, and NO2 concentrations since
2006 have remained well below the Federal standard in effect.
NO2 data from any years post-2016 were not yet available
when the EHD proposed regulations were finalized.
    We disagree that there have been at least two years of particulate
matter (PM10) violations within the past 10 years. The
PM10 standard is not expressed as a simple concentration.
Instead, EPA set a 24-hour concentration of 150 micrograms per cubic
meter (mg/m\3\) and then established that the standard would be
attained if the number of days per calendar year with a 24-hour average
concentration above 150 mg/m\3\ is equal to or less than one when
averaged over three calendar years. The two readings greater than 150
mg/m\3\, when averaged over three calendar years each, are below the
standard of 150 mg/m\3\. As shown in Table 4, PM10 levels in
the County area (as measured by the second highest 24-hour average per
year) have fluctuated between 102 mg/m\3\ and 153 mg/m\3\ over the last
decade. Also, the overall trend over the last decade is relatively
stable and has been below the standard of 150 mg/m\3\ on average.
Albuquerque and Bernalillo County have remained in attainment for the
PM10 standard for the entire period from 2006 to 2016 and
have never been designated as nonattainment prior to that period,
despite the dusty desert environment in which the city and county are
situated. See Attachment C, 4. Pleadings filed with Air Board.
    We disagree that the most recent (2016) design value for the sulfur
dioxide (SO2) level shows a secondary violation. Table 6 in
our proposed approval shows SO2 design values and how they
compare to the 1-hour primary NAAQS standard, not the 3-hour secondary
standard. The maximum permissible concentration under the 1-hour
primary standard is 75 parts per billion (ppb). The maximum permissible
concentration under the 3-hour secondary NAAQS standard is 0.5 parts
per million (ppm). As the design value is only 6 ppb for the 1-hour
NAAQS for 2016 and the previous 3 years are only 5 ppb each, the
SO2 design values are well below any violation of the
primary standard of 75 ppb or the secondary standard of .5 ppm. Note
that on Table 6 in our proposal, the design value for each year is
actually measured in ppb, not in mg/m\3\ as shown.
    Comment: Some commenters stated that there is a failure to assess
the effect of the recently changed zoning and land use ordinances of
the City of Albuquerque on where, and how many, gasoline stations may
be located near and within residential areas.
    Response: Neither the CAA nor the corresponding Federal regulations
specifically require that EPA assess the effect of local zoning and
land use ordinances when determining whether to approve a minor NSR SIP
revision. Rather, EPA is required to ensure that the revision complies
with the applicable requirements found in CAA 110(a)(2)(C), CAA 110(l),
40 CFR part 51, subpart I, 40 CFR part 51, subpart F, and appendix V to
40 CFR part 51. We have explained in the responses above, and in our
proposed rulemaking, how the SIP revision meets the requirements of CAA
110(a)(2)(C), CAA 110(l), 40 CFR part 51, subpart I, 40 CFR part 51,
subpart F, and appendix V to 40 CFR part 51. Appendix V to 40 CFR part
51 requires that states who submit SIP revisions to EPA for approval
provide evidence that they have the necessary legal authority under
state law to adopt and implement the plan. EHD provided evidence of
this authority. See Attachment C, 4. Pleadings filed with Air Board.

III. Final Action

    We are approving the revisions to the City of Albuquerque-
Bernalillo County Minor NSR program dated January 18, 2018 that
includes supplemental information provided on April 29, 2019 as
proposed. The revisions were adopted and submitted in accordance with
the requirements of the CAA and

the EPA's regulations regarding SIP development at 40 CFR part 51.
Additionally, we have determined that the submitted revisions to the
City of Albuquerque-Bernalillo County Minor NSR program are consistent
with CAA section 110(l), the EPA's regulations at 40 CFR 51.160--51.164
and the associated policy and guidance. Therefore, under section 110 of
the Act, the EPA approves into the New Mexico SIP for the City of
Albuquerque-Bernalillo County the following revisions adopted on
November 8, 2017, and submitted to the EPA on January 18, 2018:

 Addition of 20.11.39 NMAC PERMIT WAIVERS AND AIR QUALITY
NOTIFICATIONS FOR CERTAIN SOURCE CATEGORIES
 <IP_ADDRESS> NMAC Issuing Agency
 <IP_ADDRESS> NMAC Scope
 <IP_ADDRESS> NMAC Statutory Authority
 <IP_ADDRESS> NMAC Duration
 <IP_ADDRESS> NMAC Effective Date
 <IP_ADDRESS> NMAC Objective
 <IP_ADDRESS> NMAC Definitions
 <IP_ADDRESS> NMAC Variances
 <IP_ADDRESS> NMAC Savings Clause
 <IP_ADDRESS> NMAC Severability
 <IP_ADDRESS> NMAC Documents
 <IP_ADDRESS> NMAC Permit Waivers
 <IP_ADDRESS> NMAC Requirements for Source Categories to Which
Part 39 Applies
 <IP_ADDRESS> NMAC Air Quality Notification Application
 <IP_ADDRESS> NMAC AQN Application Review
 <IP_ADDRESS> NMAC Transfer of Prior Authorizations to AQNs
 <IP_ADDRESS> NMAC Compliance and Enforcement
 <IP_ADDRESS> NMAC Amending and Air Quality Notification
 <IP_ADDRESS> NMAC Fees
 <IP_ADDRESS> NMAC AQN Cancellation
 20.11.41 NMAC CONSTRUCTION PERMITS
 <IP_ADDRESS>(E)(2) NMAC Additional Permit Requirements
 <IP_ADDRESS>(G) NMAC Permissive Waiver

IV. Incorporation by Reference

    In this rule, we are finalizing regulatory text that includes
incorporation by reference. In accordance with 5 U.S.C. 552(a) and 1
CFR part 51, the revisions to the New Mexico, Albuquerque/Bernalillo
County regulations, as described in the Final Action section above, are
requirements incorporated by reference. We have made, and will continue
to make, these materials generally available electronically through
www.regulations.gov and in hard copy at the EPA Region 6 office (please
contact Rick Barrett for more information).

V. Statutory and Executive Order Reviews

    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 CAA. Accordingly, this
action merely approves state law as meeting Federal requirements and
does not impose additional requirements beyond those imposed by state
law. For that reason, this action:
     Is not a ``significant regulatory action'' subject to
review by the Office of Management and Budget under Executive Orders
12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21,
2011);
     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, described in the Unfunded Mandates
Reform Act of 1995 (Pub. L. 104-4);
     Does not have federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999);
     Is not an economically significant regulatory action based
on health or safety risks subject to Executive Order 13045 (62 FR
19885, April 23, 1997);
     Is not a significant regulatory action subject to
Executive Order 13211 (66 FR 28355, May 22, 2001);
     Is not subject to requirements of section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272
note) because application of those requirements would be inconsistent
with the CAA; and
     Does not provide EPA with the discretionary authority to
address, as appropriate, disproportionate human health or environmental
effects, using practicable and legally permissible methods, under
Executive Order 12898 (59 FR 7629, February 16, 1994).
    In addition, the SIP is not approved to apply on any Indian
reservation land or in any other area where EPA or an Indian tribe has
demonstrated that a tribe has jurisdiction. In those areas of Indian
country, the proposed rule does not have tribal implications and will
not impose substantial direct costs on tribal governments or preempt
tribal law as specified by Executive Order 13175 (65 FR 67249, November
9, 2000).
    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. EPA will submit a report containing this action and
other required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of the rule in the Federal Register. A major rule cannot
take effect until 60 days after it is published in the Federal
Register. This action is not a ``major rule'' as defined by 5 U.S.C.
804(2).
    Under section 307(b)(1) of the Clean Air Act, petitions for
judicial review of this action must be filed in the United States Court
of Appeals for the appropriate circuit by March 16, 2020. 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, Nitrogen
dioxide, Ozone, Particulate matter, Reporting and recordkeeping
requirements, Sulfur oxides, Volatile organic compounds.

    Dated: December 23, 2019.
Kenley McQueen,
Regional Administrator, Region 6.

    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 GG--New Mexico

0
2. In Sec.  52.1620(c), the second table titled ``EPA Approved
Albuquerque/Bernalillo County, NM Regulations'' is amended by adding an
entry in alphanumerical order for ``Part 39 (20.11.39 NMAC)'' and
revising the entry for ``Part 41 (20.11.41 NMAC)'' to read as follows:

Sec.  52.1620  Identification of plan.

* * * * *
    (c) * * *

                           EPA-Approved Albuquerque/Bernalillo County, NM Regulations
----------------------------------------------------------------------------------------------------------------
                                                            State
                                                          approval/
          State citation               Title/subject      effective     EPA approval date        Explanation
                                                             date
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
Part 39 (20.11.39 NMAC)..........  Permit Waivers and      1/18/2018  1/16/2020, [Insert
                                    Air Quality                        Federal Register
                                    Notifications for                  citation].
                                    Certain Sources.

                                                  * * * * * * *
Part 41 (20.11.41 NMAC)..........  Construction Permits    1/18/2018  1/16/2020, [Insert
                                                                       Federal Register
                                                                       citation].

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

* * * * *
[FR Doc. 2020-00286 Filed 1-15-20; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register Volume 84, Number 44 (Wednesday, March 6, 2019)]
[Rules and Regulations]
[Pages 7995-7997]
[FR Doc No: 2019-04014]

=======================================================================
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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket Number USCG-2019-0126]
RIN 1625-AA00

Safety Zone; Lower Mississippi River, Port Gibson, MS

AGENCY: Coast Guard, DHS.

ACTION: Temporary final rule.

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

SUMMARY: The Coast Guard is establishing an emergency temporary safety
zone for all navigable waters of the Lower Mississippi River, extending
the entire width of the river, from mile marker (MM) 405 to MM 408.
This emergency safety zone is necessary to protect persons, property,
and infrastructure from potential damage and safety hazards associated
with vessels transiting this area during high water. This rule
prohibits persons and vessels from entering the safety zone area unless
specifically authorized by the Captain of the Port Sector Lower
Mississippi River (COTP) or a designated representative.

DATES: This rule is effective without actual notice from March 6, 2019
through 7 p.m. on April 15, 2019, or until the high water event ceases,
whichever occurs first. For the purposes of enforcement, actual notice
will be used from February 28, 2019 through March 6, 2019.

ADDRESSES: To view documents mentioned in this preamble as being
available in the docket, go to http://www.regulations.gov, type USCG-
2019-0126 in the ``SEARCH'' box and click ``SEARCH.'' Click on ``Open
Docket Folder'' on the line associated with this rule.

FOR FURTHER INFORMATION CONTACT: If you have questions on this rule,
call or email Petty Officer Todd Manow, Sector Lower Mississippi River
Prevention Department, U.S. Coast Guard; telephone<PHONE_NUMBER>, email
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Table of Abbreviations

CFR Code of Federal Regulations
COTP Captain of the Port Sector Lower Mississippi River
DHS Department of Homeland Security
FR Federal Register
NPRM Notice of proposed rulemaking
Sec.  Section
U.S.C. United States Code

II. Background Information and Regulatory History

    The Coast Guard is issuing this temporary rule without prior notice
and opportunity to comment pursuant to authority under section 4(a) of
the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This
provision authorizes an agency to issue a rule without prior notice and
opportunity to comment when the agency for good cause finds that those
procedures are ``impracticable, unnecessary, or contrary to the public
interest.'' Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good
cause exists for not publishing a notice of proposed rulemaking (NPRM)
with respect to this rule because it is impracticable. Increasing high
water in

this area requires immediate action to protect persons, property and
power plant infrastructure from the potential safety hazards associated
with vessels transiting this area during high water. This safety zone
must be established immediately to protect people and vessels
associated with and resulting from the high water and we lack
sufficient time to provide a reasonable comment period and then
consider those comments before issuing the rule.
    Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause
exists for making it effective less than 30 days after publication in
the Federal Register. Delaying the effective date of this rule would be
contrary to public interest because immediate action is needed to
protect personnel, vessels, and the marine environment from potential
hazards created by the increasing high water.

III. Legal Authority and Need for Rule

    The Coast Guard is issuing this rule under authority in 46 U.S.C.
70034. The Captain of the Port Sector Lower Mississippi River (COTP)
has determined that there are potential hazards associated with
increasing high water, including possible emergency operations to
repair damage to power distribution infrastructure taking place on the
left descending bank of the Lower Mississippi River between Mile Marker
(MM) 405 and 408 in the vicinity of the Entergy Grand Gulf Nuclear
Power Facility, in Port Gibson, MS. Loss of the power distribution
lines system would be catastrophic to large areas of Louisiana and
Mississippi. This rule is needed to protect persons, property, and
infrastructure from potential damage and safety hazards associated with
vessels transiting this safety zone during high water.

IV. Discussion of the Rule

    The Coast Guard is establishing a temporary safety zone for all
navigable waters of the Lower Mississippi River, extending the entire
width of the river, from MM 405 to MM 408. Transit into and through
this area is prohibited for all traffic beginning on February 28, 2019
to continue through 7 p.m. on April 15, 2019. The COTP will terminate
the enforcement of this safety zone before April 15, 2019, if the high
water event ceases. Entry into this safety zone is prohibited unless
specifically authorized by the COTP or a designated representative. A
designated representative is a commissioned, warrant, or petty officer
of the U.S. Coast Guard assigned to units under the operational control
of USCG Sector Lower Mississippi River.
    Requests for entry will be considered and reviewed on a case-by-
case basis. The COTP may be contacted by telephone at 1-866-777-2784 or
can be reached by VHF-FM channel 16. Persons and vessels permitted to
transit this safety zone shall not meet, pass, or overtake any vessel
currently transiting, shall maintain slowest speed for safe navigation,
and shall comply with all lawful directions issued by the COTP or the
designated representative.
    This safety zone may include closures and/or navigation
restrictions and requirements that are vital to maintaining safe
navigation on the Lower Mississippi River during the high water.
Moreover, the Coast Guard will issue Broadcast Notice to Mariners via
VHF-FM marine channel 16 about the zone.

V. Regulatory Analyses

    We developed this rule after considering numerous statutes and
Executive orders related to rulemaking. Below we summarize our analyses
based on a number of these statutes and Executive orders, and we
discuss First Amendment rights of protestors.

A. Regulatory Planning and Review

    Executive Orders 12866 and 13563 direct agencies to assess the
costs and benefits of available regulatory alternatives and, if
regulation is necessary, to select regulatory approaches that maximize
net benefits. Executive Order 13771 directs agencies to control
regulatory costs through a budgeting process. This rule has not been
designated a ``significant regulatory action,'' under Executive Order
12866. Accordingly, this rule has not been reviewed by the Office of
Management and Budget (OMB), and pursuant to OMB guidance it is exempt
from the requirements of Executive Order 13771.
    This regulatory action determination is based on the size,
location, and duration of the safety zone. This emergency safety zone
will restrict vessel traffic from entering or transiting through a
three-mile section of the navigable waterways of the Lower Mississippi
River from MM 405 to MM 408, in the vicinity of Port Gibson, MS, from
February 28, 2019 through 7 p.m. on April 15, 2019.

B. Impact on Small Entities

    The Regulatory Flexibility Act of 1980, 5 U.S.C. 601-612, as
amended, requires Federal agencies to consider the potential impact of
regulations on small entities during rulemaking. The term ``small
entities'' comprises small businesses, not-for-profit organizations
that are independently owned and operated and are not dominant in their
fields, and governmental jurisdictions with populations of less than
50,000. The Coast Guard certifies under 5 U.S.C. 605(b) that this rule
will not have a significant economic impact on a substantial number of
small entities.
    While some owners or operators of vessels intending to transit the
temporary safety zone may be small entities, for the reasons stated in
section V.A. above, this rule will not have a significant economic
impact on any vessel owner or operator.
    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104-121), we want to assist small
entities in understanding this rule. If the rule would affect your
small business, organization, or governmental jurisdiction and you have
questions concerning its provisions or options for compliance, please
contact the person listed in the FOR FURTHER INFORMATION CONTACT
section.
    Small businesses may send comments on the actions of Federal
employees who enforce, or otherwise determine compliance with, Federal
regulations to the Small Business and Agriculture Regulatory
Enforcement Ombudsman and the Regional Small Business Regulatory
Fairness Boards. The Ombudsman evaluates these actions annually and
rates each agency's responsiveness to small business. If you wish to
comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR
(1-888-734-3247). The Coast Guard will not retaliate against small
entities that question or complain about this rule or any policy or
action of the Coast Guard.

C. Collection of Information

    This rule will not call for a new collection of information under
the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

D. Federalism and Indian Tribal Governments

    A rule has implications for federalism under Executive Order 13132,
Federalism, if it has 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. We have analyzed this rule under that Order and have
determined that it is consistent with the fundamental federalism
principles and preemption requirements described in Executive Order
13132.
    Also, this rule does not have tribal implications under Executive
Order

13175, Consultation and Coordination with Indian Tribal Governments,
because it does not have a substantial direct effect on one or more
Indian tribes, on the relationship between the Federal Government and
Indian tribes, or on the distribution of power and responsibilities
between the Federal Government and Indian tribes. If you believe this
rule has implications for federalism or Indian tribes, please contact
the person listed in the FOR FURTHER INFORMATION CONTACT section above.

E. Unfunded Mandates Reform Act

    The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538)
requires Federal agencies to assess the effects of their discretionary
regulatory actions. In particular, the Act addresses actions that may
result in the expenditure by a State, local, or tribal government, in
the aggregate, or by the private sector of $100,000,000 (adjusted for
inflation) or more in any one year. Though this rule will not result in
such expenditure, we do discuss the effects of this rule elsewhere in
this preamble.

F. Environment

    We have analyzed this rule under Department of Homeland Security
Management Directive 023-01 and Commandant Instruction M16475.lD, which
guide the Coast Guard in complying with the National Environmental
Policy Act of 1969 (42 U.S.C. 4321-4370f), and have determined that
this action is one of a category of actions that do not individually or
cumulatively have a significant effect on the human environment. This
rule involves an emergency safety zone lasting approximately one and a
half months that will prohibit entry into a three-mile stretch of the
Lower Mississippi River during a hazardous high-water event. It is
categorically excluded from further review under paragraph L60(d) of
Appendix A, Table 1 of DHS Instruction Manual 023-01-001-01, Rev. 01. A
Record of Environmental Consideration (REC) supporting this
determination will be made available in the docket where indicated
under ADDRESSES.

G. Protest Activities

    The Coast Guard respects the First Amendment rights of protesters.
Protesters are asked to contact the person listed in the FOR FURTHER
INFORMATION CONTACT section to coordinate protest activities so that
your message can be received without jeopardizing the safety or
security of people, places, or vessels.

List of Subjects in 33 CFR Part 165

    Harbors, Marine safety, Navigation (water), Reporting and
recordkeeping requirements, Security measures, Waterways.

    For the reasons discussed in the preamble, the Coast Guard amends
33 CFR part 165 as follows:

PART 165--REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS

0
1. The authority citation for part 165 continues to read as follows:

    Authority: 46 U.S.C. 70034; 46 U.S.C. 70051; 33 CFR 1.05-1,
6.04-1, 6.04-6, and 160.5; Department of Homeland Security
Delegation No. 0170.1.

0
2. Add Sec.  165.35T08-0229 to read as follows:

Sec.  165.35T08-0229  Safety Zone; Lower Mississippi River; Port
Gibson, MS.

    (a) Location. The following area is a safety zone: All navigable
waters of the Lower Mississippi River, extending the entire width of
the river, from mile marker (MM) 405 to MM 408, in the vicinity of Port
Gibson, MS.
    (b) Period of enforcement. This section is effective without actual
notice from March 6, 2019 through 7 p.m. on April 15, 2019, or until
the high water event ceases, whichever occurs first. For the purposes
of enforcement, actual notice will be used from February 28, 2019
through March 6, 2019.
    (c) Regulations. (1) In accordance with the general regulations in
Sec.  165.23 of this part, entry of vessels or persons into this zone
is prohibited unless specifically authorized by the Captain of the Port
Sector Lower Mississippi River (COTP) or a designated representative. A
designated representative is a commissioned, warrant, or petty officer
of the U.S. Coast Guard assigned to units under the operational control
of USCG Sector Lower Mississippi River.
    (2) Vessels requiring entry into this safety zone must request
permission from the COTP or a designated representative. To seek entry
into the safety zone, contact the COTP or the COTP's representative by
telephone at 1-866-777-2784 or on VHF-FM channel 16.
    (3) Persons and vessels permitted to enter this safety zone shall
not meet, pass, or overtake any vessel currently transiting, shall
maintain slowest speed for safe navigation, and shall comply with all
lawful directions issued by the COTP or the designated representative.
    (d) Informational broadcasts. This safety zone may include closures
and/or navigation restrictions and requirements that are vital to
maintaining safe navigation on this section of the Lower Mississippi
River during the high water. The COTP or a designated representative
will inform the public through broadcast notices to mariners of any
changes in the enforcement period for the safety zone.

    Dated: February 28, 2019.
R. Tamez,
Captain, U. S. Coast Guard, Captain of the Port Sector Lower
Mississippi River.
[FR Doc. 2019-04014 Filed 3-5-19; 8:45 am]
 BILLING CODE 9110-04-P


[Federal Register Volume 87, Number 214 (Monday, November 7, 2022)]
[Proposed Rules]
[Pages 66971-66974]
[FR Doc No: 2022-23567]

=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2022-1404; Project Identifier MCAI-2022-01044-A]
RIN 2120-AA64

Airworthiness Directives; Pilatus Aircraft Ltd. Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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

SUMMARY: The FAA proposes to adopt a new airworthiness directive (AD)
for certain Pilatus Aircraft Ltd. (Pilatus) Model PC-12/47E airplanes.
This proposed AD results from mandatory continuing airworthiness
information (MCAI) originated by an aviation authority of another
country to identify and correct an unsafe condition on an aviation
product. The MCAI identifies the unsafe condition as corrosion of the
actuator attachment lug areas underneath the anti-rotation pads of the
main landing gear (MLG) and nose landing gear (NLG). This proposed AD
would require replacing certain MLG and NLG electro-mechanical
actuators. The FAA is proposing this AD to address the unsafe condition
on these products.

DATES: The FAA must receive comments on this NPRM by December 22, 2022.

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-2022-1404; 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 MCAI, any comments received, and other
information. The street address for Docket Operations is listed above.

FOR FURTHER INFORMATION CONTACT: Doug Rudolph, Aviation Safety
Engineer, FAA, General Aviation & Rotorcraft Section, International
Validation Branch, 901 Locust, Room 301, Kansas City, MO 64106; phone:
(816) 329-4059; 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-2022-1404; Project Identifier
MCAI-2022-01044-A'' 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
this 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 Doug
Rudolph, Aviation Safety Engineer, FAA, General Aviation & Rotorcraft
Section, International Validation Branch, 901 Locust, Room 301, Kansas
City, MO 64106. 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 European Union Aviation Safety Agency (EASA), which is the
Technical Agent for the Member States of the European Union, has issued
EASA AD 2022-0158, dated August 4, 2022 (referred to after this as
``the MCAI''), to correct an unsafe condition on certain serial-
numbered Pilatus Model PC-12/47E airplanes.
    The MCAI was prompted by occurrences of corrosion on the MLG and
NLG actuator attachment lugs, underneath the anti-rotation pads of
Pilatus Model PC-12/47E airplanes. The MCAI states that investigations
revealed that extending or retracting the affected landing gear results
in fretting between the anti-rotation pads and the actuator attachment
lugs. This decreases the effectivity of surface protection, allows
corrosion to develop on the attachment lug areas underneath the anti-
rotation pads, and leads to cracking and failure of the attachment
lugs.
    This condition, if not addressed, could result in loss of
functionality of the MLG and NLG, which could result in damage to the
airplane and injury to the occupants. The MCAI requires inspecting, and
if required, replacing affected MLG and NLG electro-mechanical
actuators with serviceable actuators and prohibits the installation of
an affected actuator unless it has been reworked to become a
serviceable actuator.
    You may examine the MCAI in the AD docket at regulations.gov under
Docket No. FAA-2022-1404.

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 this State of Design
Authority, it has notified the FAA of the unsafe condition described in
the MCAI and service information described above. The FAA is issuing
this NPRM after determining that the unsafe condition described
previously is likely to exist or develop on other products of the same
type design.

Proposed AD Requirements in This NPRM

    This proposed AD would require replacing affected MLG and NLG
actuators with serviceable actuators (either improved part number
actuators or reworked (inspection and modification) actuators) and
prohibits the installation of an affected actuator unless it has been
reworked (inspection and modification) to become a serviceable
actuator.

Differences Between This Proposed AD and the MCAI

    The MCAI bases the compliance time for the replacement of affected
MLG and NLG electro-mechanical actuators on the corrosion environment
of the airplane. FAA regulations do not require operators to track
operations in different environmental conditions and thus there is no
way to determine whether an airplane is in the category of moderate to
severe or mild corrosion environment. Therefore, this proposed AD would
establish the compliance time for the replacement as within 3 months
after the effective date of the final rule, regardless of the
airplane's operating environment.
    The MCAI and the proposed AD affect the same serial-numbered Model
PC-12/47E airplanes, but the MCAI limits the requirement for
replacement to certain serial-numbered PC-12/47E airplanes with an
affected electro-mechanical landing gear installed and prohibits
installation of the affected landing gear on all airplanes in the
applicability. Pilatus has notified the FAA that all the airplanes in
the applicability should be part of the proposed replacement
requirements and installation prohibition. EASA is considering a
revision to the MCAI based on this information. Because of this, the
proposed AD would require the replacement on all serial-numbered Model
PC-12/47E airplanes in the applicability of the proposed AD.

Costs of Compliance

    The FAA estimates that this AD, if adopted as proposed, would
affect 440 airplanes of U.S. registry.
    The FAA estimates that the costs of one of the two actions below
would be required to comply with this proposed AD:

                                                 Estimated Costs
----------------------------------------------------------------------------------------------------------------
                                                                                Cost on U.S.
              Action                    Labor cost           Parts cost        Cost per product      operators
----------------------------------------------------------------------------------------------------------------
Rework (inspection and             5 work-hours x $85   $1,245 (if needed).  $1,670 (for rework         $734,800
 modification) *.                   per hour = $425.                          of all three
                                                                              actuators).
Replacement *....................  3 work-hours x $85   $4,750 (Actuator P/  $16,105 (for              7,086,200
                                    per hour = $255.     N 9<IP_ADDRESS>2,     replacement of all
                                                         nose landing gear)   three actuators).
                                                         and $11,100.
                                                        (for 2 actuators--
                                                         Actuator P/N
                                                         6<IP_ADDRESS>3,
                                                         main landing gear).
----------------------------------------------------------------------------------------------------------------
* Only the rework (inspection and modification) or the replacement would be required by this proposed AD. Both
  actions would not be required.

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 this 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 adding the following new airworthiness
directive:

Pilatus Aircraft Ltd.: Docket No. FAA-2022-1404; Project Identifier
MCAI-2022-01044-A.

(a) Comments Due Date

    The FAA must receive comments on this airworthiness directive
(AD) by December 22, 2022.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to Pilatus Aircraft Ltd. Model PC-12/47E
airplanes, serial number (S/N) 1300 and S/Ns 1451 and higher,
certificated in any category.

(d) Subject

    Joint Aircraft System Component (JASC) Code 3211, Main Landing
Gear Attach Section; and JASC Code 3221, Nose/Tail Landing Gear
Attach Section.

(e) Unsafe Condition

    This AD was prompted by mandatory continuing airworthiness
information (MCAI) originated by an aviation authority of another
country to identify and correct an unsafe condition on an aviation
product. The MCAI identifies the unsafe condition as corrosion
leading to cracks on the actuator attachment lug areas underneath
the anti-rotation pads of the main landing gear (MLG) and nose
landing gear (NLG). The FAA is issuing this AD to address this
condition. The unsafe condition, if not addressed, could result in
loss of functionality of the MLG and NLG, which could result in
damage to the airplane and injury to the occupants.

(f) Definitions

    For the purposes of this AD, the following definitions apply:
    (1) Affected parts are defined as MLG electro-mechanical
actuators having part number (P/N) 9<IP_ADDRESS>3 or P/N
9<IP_ADDRESS>5 and NLG electro-mechanical actuators having P/N
9<IP_ADDRESS>4 or P/N 9<IP_ADDRESS>4.
    (2) Serviceable parts are defined as one of the following:
    (i) MLG electro-mechanical actuators having P/N 9<IP_ADDRESS>3 or
P/N 9<IP_ADDRESS>5 and NLG electro-mechanical actuators having P/N
9<IP_ADDRESS>4 or P/N 9<IP_ADDRESS>4 that have been reworked
(inspection and modification) in accordance with the instructions in
Pilatus PC-12 Service Bulletin No. 32-030, dated June 27, 2022; and
Tamagawa Seiki Co., Ltd., Service Bulletin No. SB21-0001, dated
March 31, 2022; or
    (ii) MLG electro-mechanical actuators having P/N 9<IP_ADDRESS>3
and NLG electro-mechanical actuators having P/N 9<IP_ADDRESS>2.

(g) Compliance

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

(h) Actions

    (1) Within 3 months after the effective date of this AD, replace
each affected part as defined in paragraph (f)(1) of this AD with a
serviceable part as defined in either paragraph (f)(2)(i) or (ii) of
this AD.
    (2) As of the effective date of this AD, do not install an
affected part as defined in paragraph (f)(1) of this AD on any
airplane unless it has been reworked (inspection and modification)
and made a serviceable part as defined in paragraph (f)(2)(i) of
this AD.

(i) Alternative Methods of Compliance (AMOCs)

    The Manager, International Validation Branch, FAA, has the
authority to approve AMOCs for this AD, if requested using the
procedures found in Sec.  39.19. In accordance with Sec.  39.19,
send your request to your principal inspector or local Flight
Standards District Office, as appropriate. If sending information
directly to the manager of the International Validation Branch, mail
it to the address identified in paragraph (j)(2) of this AD or email
to: [email protected]. If mailing information, also submit
information by email.

(j) Additional Information

    (1) Refer to European Union Aviation Safety Agency (EASA) AD
2022-0158, dated August 4, 2022, for related information. This EASA
AD may be found in the AD docket at regulations.gov under Docket No.
FAA-2022-1404.

    (2) For more information about this AD, contact Doug Rudolph,
Aviation Safety Engineer, General Aviation & Rotorcraft Section,
FAA, General Aviation & Rotorcraft Section, International Validation
Branch, 901 Locust, Room 301, Kansas City, MO 64106; phone: (816)
329-4059; email: [email protected].
    (3) For Pilatus and Tamagawa Seiki Co., Ltd. service information
that is not incorporated by reference in this AD, contact Pilatus
Aircraft Limited, Customer Support General Aviation, CH-6371 Stans,
Switzerland; phone: +41 848 24 7 365; email: aircraft.com">[email protected]aircraft.com; website: pilatus-aircraft.com.

(k) Material Incorporated by Reference

    None.

    Issued on October 25, 2022.
Christina Underwood,
Acting Director, Compliance & Airworthiness Division, Aircraft
Certification Service.
[FR Doc. 2022-23567 Filed 11-4-22; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 79, Number 128 (Thursday, July 3, 2014)]
[Rules and Regulations]
[Pages 37948-37950]
[FR Doc No: 2014-15626]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 890

[Docket No. FDA-2014-M-0701]

Medical Devices; Physical Medicine Devices; Classification of the
Nonpowered Lower Extremity Pressure Wrap

AGENCY: Food and Drug Administration, HHS.

ACTION: Final order.

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

SUMMARY: The Food and Drug Administration (FDA) is classifying the
nonpowered lower extremity pressure

wrap into class I (general controls). The Agency is classifying the
device into class I (general controls) in order to provide a reasonable
assurance of safety and effectiveness of the device.

DATES: This order is effective August 4, 2014. The classification was
applicable on December 18, 2013.

FOR FURTHER INFORMATION CONTACT: Michael Hoffmann, Center for Devices
and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, Rm. 1434, Silver Spring, MD 20993-0002, 301-
796-6476<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    In accordance with section 513(f)(1) of the Federal Food, Drug, and
Cosmetic Act (the FD&C Act) (21 U.S.C. 360c(f)(1)), devices that were
not in commercial distribution before May 28, 1976 (the date of
enactment of the Medical Device Amendments of 1976), generally referred
to as postamendments devices, are classified automatically by statute
into class III without any FDA rulemaking process. These devices remain
in class III and require premarket approval, unless and until the
device is classified or reclassified into class I or II, or FDA issues
an order finding the device to be substantially equivalent, in
accordance with section 513(i) of the FD&C Act, to a predicate device
that does not require premarket approval. The Agency determines whether
new devices are substantially equivalent to predicate devices by means
of premarket notification procedures in section 510(k) of the FD&C Act
(21 U.S.C. 360(k)) and 21 CFR part 807 of the regulations.
    Section 513(f)(2) of the FD&C Act, as amended by section 607 of the
Food and Drug Administration Safety and Innovation Act (Pub. L. 112-
144), provides two procedures by which a person may request FDA to
classify a device under the criteria set forth in section 513(a)(1).
Under the first procedure, the person submits a premarket notification
under section 510(k) of the FD&C Act for a device that has not
previously been classified and, within 30 days of receiving an order
classifying the device into class III under section 513(f)(1) of the
FD&C Act, the person requests a classification under section 513(f)(2).
Under the second procedure, rather than first submitting a premarket
notification under section 510(k) and then a request for classification
under the first procedure, the person determines that there is no
legally marketed device upon which to base a determination of
substantial equivalence and requests a classification under section
513(f)(2) of the FD&C Act. If the person submits a request to classify
the device under this second procedure, FDA may decline to undertake
the classification request if FDA identifies a legally marketed device
that could provide a reasonable basis for review of substantial
equivalence with the device or if FDA determines that the device
submitted is not of ``low-moderate risk'' or that general controls
would be inadequate to control the risks and special controls to
mitigate the risks cannot be developed.
    In response to a request to classify a device under either
procedure provided by section 513(f)(2) of the FD&C Act, FDA will
classify the device by written order within 120 days. This
classification will be the initial classification of the device. In
accordance with section 513(f)(1) of the FD&C Act, FDA issued an order
on January 7, 2011, classifying the Restless Legs Device, into class
III, because it was not substantially equivalent to a device that was
introduced or delivered for introduction into interstate commerce for
commercial distribution before May 28, 1976, or a device which was
subsequently reclassified into class I or class II. On January 23,
2011, Mary M. Sorg dba PJ Sleeper's, submitted a request for
classification of the Restless Leg Device under section 513(f)(2) of
the FD&C Act. The manufacturer recommended that the device be
classified into class I (Ref. 1).
    In accordance with section 513(f)(2) of the FD&C Act, FDA reviewed
the request in order to classify the device under the criteria for
classification set forth in section 513(a)(1) of the FD&C Act. FDA
classifies devices into class I if general controls by themselves are
sufficient to provide reasonable assurance of safety and effectiveness
of the device for its intended use. After review of the information
submitted in the de novo request, FDA determined that the device can be
classified into class I. FDA believes general controls will provide
reasonable assurance of the safety and effectiveness of the device.
    Therefore, on December 18, 2013, FDA issued an order to the
requester classifying the device into class I. FDA is codifying the
classification of the device by adding Sec.  890.5760. The device is
assigned the generic name nonpowered lower extremity pressure wrap, and
it is identified as a prescription device that applies mechanical
pressure by wrapping around the lower extremity, such as the leg or
foot, and is intended for primary Restless Leg Syndrome.
    FDA believes that general controls provide reasonable assurance of
safety and effectiveness. Nonpowered lower extremity pressure wraps are
prescription devices restricted to patient use only upon the
authorization of a practitioner licensed by law to administer or use
the device. ((21 CFR 882.1440(a)); see section 520(e) of the FD&C Act
(21 U.S.C. 360j(e)) and 21 CFR 801.109 (Prescription devices).)
Prescription-use restrictions are a type of general controls as defined
in section 513(a)(1)(A)(i) of the FD&C Act.

II. Environmental Impact

    The Agency has determined under 21 CFR 25.34(b) that this action is
of a type that does not individually or cumulatively have a significant
effect on the human environment. Therefore, neither an environmental
assessment nor an environmental impact statement is required.

III. Paperwork Reduction Act of 1995

    This final administrative order establishes special controls that
refer to previously approved collections of information found in other
FDA regulations. These collections of information are subject to review
by the Office of Management and Budget (OMB) under the Paperwork
Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections of
information in 21 CFR part 801, regarding labeling, have been approved
under OMB control number 0910-0485.

IV. Reference

    The following reference has been placed on display in the Division
of Dockets Management (HFA-305), Food and Drug Administration, 5630
Fishers Lane, Rm. 1061, Rockville, MD 20852, and may be seen by
interested persons between 9 a.m. and 4 p.m., Monday through Friday,
and is available electronically at http://www.regulations.gov.

    1. Request for automatic Class III designation under (De Novo)
513(f)(2) 510(k) K102707, from Mary M. Sorg dba PJ
Sleeper's, January 23, 2011.

List of Subjects in 21 CFR Part 890

    Medical devices, Physical medicine devices.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR part
890 is amended as follows:

PART 890--PHYSICAL MEDICINE DEVICES

0
1. The authority citation for 21 CFR part 890 continues to read as
follows:

    Authority:  21 U.S.C. 351, 360, 360c, 360e, 360j, 371.

0
2. Add Sec.  890.5760 to subpart F to read as follows:

Sec.  890.5760  Nonpowered lower extremity pressure wrap.

    (a) Identification. A nonpowered lower extremity pressure wrap is a
prescription device that applies mechanical pressure by wrapping around
the lower extremity, such as the leg or foot, and is intended for
primary Restless Leg Syndrome.
    (b) Classification. Class I (general controls). The device is
exempt from the premarket notification procedures in subpart E of part
807 of this chapter, subject to the limitations in Sec.  890.9.

    Dated: June 27, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-15626 Filed 7-2-14; 8:45 am]
BILLING CODE 4164-01-P