[Federal Register Volume 87, Number 39 (Monday, February 28, 2022)]
[Notices]
[Pages 11065-11066]
[FR Doc No: 2022-04128]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings

    Take notice that the Commission has received the following Natural
Gas Pipeline Rate and Refund Report filings:

Filings Instituting Proceedings

    Docket Numbers: RP22-568-000.
    Applicants: Columbia Gas Transmission, LLC.
    Description: Compliance filing: Annual Report on Operational
Transactions 2022 to be effective N/A.
    Filed Date: 2/18/22.
    Accession Number: 20220218-5191.
    Comment Date: 5 p.m. ET 3/2/22.

    Docket Numbers: RP22-569-000.
    Applicants: Hardy Storage Company, LLC.
    Description: Compliance filing: Annual Report on Operational
Transactions 2022 to be effective N/A.
    Filed Date: 2/18/22.
    Accession Number: 20220218-5192.
    Comment Date: 5 p.m. ET 3/2/22.

    Docket Numbers: RP22-570-000.
    Applicants: Crossroads Pipeline Company.
    Description: Compliance filing: Annual Report on Operational
Transactions 2022 to be effective N/A.
    Filed Date: 2/18/22.
    Accession Number: 20220218-5196.
    Comment Date: 5 p.m. ET 3/2/22.

    Docket Numbers: RP22-571-000.
    Applicants: Columbia Gulf Transmission, LLC.
    Description: Compliance filing: Annual Report on Operational
Transactions 2022 to be effective N/A.
    Filed Date: 2/18/22.
    Accession Number: 20220218-5212.
    Comment Date: 5 p.m. ET 3/2/22.

    Docket Numbers: RP22-572-000.
    Applicants: Perryville Gas Storage LLC.
    Description: Sec.  4(d) Rate Filing: Perryville Gas Storage
SubmitsTariff Modifications to be effective 3/21/2022.
    Filed Date: 2/18/22.
    Accession Number: 20220218-5218.
    Comment Date: 5 p.m. ET 3/2/22.

    Docket Numbers: RP22-573-000.
    Applicants: Golden Pass Pipeline LLC.
    Description: Compliance filing: Golden Pass Pipeline LLC 2021
Operational Purchases and Sales Report to be effective N/A.
    Filed Date: 2/22/22.
    Accession Number: 20220222-5094.
    Comment Date: 5 p.m. ET 3/7/22.

    Any person desiring to intervene or protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00
p.m. Eastern time on the specified comment date. Protests may be
considered, but intervention is necessary to become a party to the
proceeding.

Filings in Existing Proceedings

    Docket Numbers: RP22-574-000.
    Applicants: Golden Pass Pipeline LLC.
    Description: Sec.  4(d) Rate Filing: 2022 GPPL FERC Gas Tariff
Clean Up to be effective 4/1/2022.
    Filed Date: 2/22/22.
    Accession Number: 20220222-5135.
    Comment Date: 5 p.m. ET 3/7/22.

    Any person desiring to protest in any the above proceedings must
file in accordance with Rule 211 of the Commission's Regulations (18
CFR 385.211) on or before 5:00 p.m. Eastern time on the specified
comment date.
    The filings are accessible in the Commission's eLibrary system
(https://elibrary.ferc.gov/idmws/search/fercgensearch.asp) by querying
the docket number.
    eFiling is encouraged. More detailed information relating to filing
requirements, interventions, protests, service, and qualifying
facilities filings can be found at: http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other information, call<PHONE_NUMBER>
(toll free). For TTY, call<PHONE_NUMBER>.

    Dated: February 22, 2022.
Debbie-Anne A. Reese,
Deputy Secretary.
[FR Doc. 2022-04128 Filed 2-25-22; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 85, Number 240 (Monday, December 14, 2020)]
[Proposed Rules]
[Pages 80689-80693]
[FR Doc No: 2020-27416]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2020-1123; Project Identifier MCAI-2020-01294-R]
RIN 2120-AA64

Airworthiness Directives; Airbus Helicopters

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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SUMMARY: The FAA proposes to supersede Airworthiness Directive (AD)
2016-23-05, which applies to certain Airbus Helicopters Model SA-365N1,
AS-365N2, AS 365 N3, SA-366G1, EC 155B, and EC155B1 helicopters. AD
2016-23-05 requires repetitive checks of the oil level of the tail
rotor gearbox and, if necessary, filling the oil to the

maximum level; and replacement of a certain control rod double bearing
(bearing) with a new bearing. Since issuing AD 2016-23-05, the FAA has
determined additional inspections, replacements, and modifications are
necessary to address the unsafe condition. This proposed AD would
retain the requirements of AD 2016-23-05 and would add helicopters to
the applicability. This proposed AD would also require modifying the
helicopter by replacing the tail gearbox (TGB) control shaft guide
bushes; repetitive inspections of the TGB magnetic plug and corrective
actions if necessary; repetitive replacements of the bearing; and
modifying the helicopter by replacing the TGB; as specified in a
European Union Aviation Safety Agency (EASA) AD, which will be
incorporated by reference. The FAA is proposing this AD to address the
unsafe condition on these products.

DATES: The FAA must receive comments on this proposed AD by January 28,
2021.

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 https://www.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.
    For material incorporated by reference (IBR) in this AD, contact
the EASA, Konrad-Adenauer-Ufer 3, 50668 Cologne, Germany; telephone +49
221 8999 000; email<EMAIL_ADDRESS>internet www.easa.europa.eu.
You may find this IBR material on the EASA website at https://ad.easa.europa.eu. You may view this IBR material at the FAA, Office of
the Regional Counsel, Southwest Region, 10101 Hillwood Pkwy., Room 6N-
321, Fort Worth, TX 76177. For information on the availability of this
material at the FAA, call<PHONE_NUMBER>. It is also available in the AD
docket on the internet at https://www.regulations.gov by searching for
and locating Docket No. FAA-2020-1123.

Examining the AD Docket

    You may examine the AD docket on the internet at https://www.regulations.gov by searching for and locating Docket No. FAA-2020-
1123; 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, any comments received, and other information. The street
address for Docket Operations is listed above. Comments will be
available in the AD docket shortly after receipt.

FOR FURTHER INFORMATION CONTACT: Kathleen Arrigotti, Aviation Safety
Engineer, Large Aircraft Section, International Validation Branch, FAA,
2200 South 216th St., Des Moines, WA 98198; telephone and fax 206-231-
3218; email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Comments Invited

    The FAA invites you to participate in this rulemaking by submitting
written comments, data, or views about this proposal. The most helpful
comments reference a specific portion of the proposal, explain the
reason for any recommended change, and include supporting data. To
ensure the docket does not contain duplicate comments, commenters
should submit only one copy of the comments. Send your comments to an
address listed under the ADDRESSES section. Include ``Docket No. FAA
20_2020-1123; Project Identifier MCAI-2020-01294-R'' at the beginning
of your 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, as well
as a report summarizing each substantive public contact with FAA
personnel concerning this proposed rulemaking. Before acting on this
proposal, the FAA will consider all comments received by the closing
date for comments. The FAA will consider comments filed after the
comment period has closed if it is possible to do so without incurring
expense or delay. The FAA may change this NPRM because of those
comments.

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
Kathleen Arrigotti, Aviation Safety Engineer, Large Aircraft Section,
International Validation Branch, FAA, 2200 South 216th St., Des Moines,
WA 98198; telephone and fax<PHONE_NUMBER>; email
<EMAIL_ADDRESS>Any commentary that the FAA receives which
is not specifically designated as CBI will be placed in the public
docket for this rulemaking.

Discussion

    The FAA issued AD 2016-23-05, Amendment 39-18712 (81 FR 85126,
November 25, 2016) (``AD 2016-23-05''), which applies to certain Airbus
Helicopters Model SA-365N1, AS-365N2, AS 365 N3, SA-366G1, EC 155B, and
EC155B1 helicopters. AD 2016-23-05 requires repetitive checks of the
oil level of the tail rotor gearbox and, if necessary, filling the oil
to the maximum level; and replacement of a certain bearing with a new
part-numbered bearing. The FAA issued AD 2016-23-05 to address damage
to the bearing, which could result in end play, loss of tail rotor
pitch control, and subsequent loss of control of the helicopter.

Actions Since AD 2016-23-05 Was Issued

    Since the FAA issued AD 2016-23-05, the FAA has determined
additional repetitive inspections of the TGB magnetic plug for the
presence of particles (and corrective actions if necessary), repetitive
replacements of the bearing, and modifications (replacing TGB control
shaft guide bushes and replacing the TGB) are necessary to address the
unsafe condition.
    The EASA, which is the Technical Agent for the Member States of the
European Union, has issued EASA AD 2017-0125, dated July 21, 2017
(``EASA AD 2017-0125'') (also referred to as the Mandatory Continuing
Airworthiness Information, or ``the MCAI''), to correct an unsafe
condition for all Airbus Helicopters Model SA 365 N1, AS 365 N2, AS 365
N3, SA 366 G1, EC 155 B, and EC 155 B1 helicopters. EASA AD 2017-0125
supersedes EASA AD 2017-0007, dated January 13, 2017, which superseded
EASA AD 2016-0097R1, dated May 25, 2016 (which corresponds to FAA AD
2016-23-05). EASA AD 2017-0125 adds helicopters to the

applicability, adds repetitive inspections of the magnetic plug after
bearing replacement, requires the use of the revised Airbus Helicopters
Alert Service Bulletin (ASB) instructions, and requires replacement of
the TGB with a modified unit, which terminates the repetitive
inspections.
    This proposed AD was prompted by a determination that additional
inspections, replacements, and modifications are necessary to address
the unsafe condition. The FAA is proposing this AD to address damage to
the bearing, which could result in end play, loss of tail rotor pitch
control, and subsequent loss of control of the helicopter. See the MCAI
for additional background information.

Comments on AD 2016-23-05

    The FAA gave the public the opportunity to comment on AD 2016-23-
05. The following presents the comments received on AD 2016-23-05 and
the FAA's response to each comment.

Request To Revise the Applicability To Exclude Certain TGBs

    A commenter requested that the FAA revise the applicability of AD
2016-23-05 to exclude TGBs that are post-Airbus Helicopters mod 07
65B63 having part number (P/N) 365A33-6005-09. The commenter stated
that the referenced service information clarifies that only TGBs that
are pre-Airbus Helicopters mod 07 65B63 are affected.
    The FAA disagrees. In developing AD 2016-23-05, the FAA differed
with EASA AD 2016-0097R1, dated May 25, 2016, and the referenced
service information. The FAA determined that TGBs that are post-Airbus
Helicopters mod 07 65B63 having P/N 365A33-6005-09 should not be
excluded from the requirements of that AD. However, the FAA notes that
the new MCAI addresses TGBs that are pre-Airbus Helicopters mod 07
65B63 and TGBs that are post-Airbus Helicopters mod 07 65B63
separately, as does this proposed AD.

Request To Revise the Applicability To Include All TGBs

    A commenter requested that the FAA revise the applicability of AD
2016-23-05 to include all TGBs. The commenter stated the applicability
for AD 2016-23-05 should be the same as AD 2007-25-08, Amendment 39-
15290 (72 FR 69604, December 10, 2007), which included all bearings,
regardless of the part number of the TGB.
    The FAA disagrees. In developing AD 2016-23-05, the FAA determined
the requirement to check the oil level is only necessary for
helicopters with a TGB bearing having P/N 704A33-651-093 or P/N 704A33-
651-104. However, the FAA notes that the new MCAI requires the oil
level check for all TGBs, as does this proposed AD.

Related Service Information Under 1 CFR Part 51

    EASA AD 2017-0125 describes procedures for modifying the helicopter
by replacing TGB control shaft guide bushes, repetitive inspections
(checks) of the oil level of the tail rotor gearbox and, if necessary,
filling the oil to the maximum level, repetitive inspections of the TGB
magnetic plug for the presence of particles and corrective actions if
necessary (corrective actions include removing the TGB, complying with
certain work cards to address particles and other conditions such as
abrasions, scales, flakes, and splinters, and replacing the bearing),
repetitive replacements of the bearing; and modifying the helicopter by
replacing the TGB.
    This material is reasonably available because the interested
parties have access to it through their normal course of business or by
the means identified in the ADDRESSES section.

FAA's Determination and Requirements of This Proposed AD

    This product has been approved by the aviation authority of another
country, and is approved for operation in the United States. Pursuant
to the bilateral agreement with the State of Design Authority, the FAA
has been notified of the unsafe condition described in the MCAI
referenced above. The FAA is proposing this AD because the FAA
evaluated all the relevant information and determined the unsafe
condition described previously is likely to exist or develop in other
products of the same type design.

Proposed AD Requirements

    This proposed AD would retain the actions required by AD 2016-23-05
and would require accomplishing the actions specified in EASA AD 2017-
0125 described previously, as incorporated by reference, except for any
differences identified as exceptions in the regulatory text of this AD
and except as discussed under ``Differences Between this Proposed AD
and the MCAI.''

Explanation of Required Compliance Information

    In the FAA's ongoing efforts to improve the efficiency of the AD
process, the FAA initially worked with Airbus and EASA to develop a
process to use certain EASA ADs as the primary source of information
for compliance with requirements for corresponding FAA ADs. The FAA has
since coordinated with other manufacturers and civil aviation
authorities (CAAs) to use this process. As a result, EASA AD 2017-0125
will be incorporated by reference in the FAA final rule. This proposed
AD would, therefore, require compliance with EASA AD 2017-0125 in its
entirety, through that incorporation, except for any differences
identified as exceptions in the regulatory text of this proposed AD.
Using common terms that are the same as the heading of a particular
section in the EASA AD does not mean that operators need comply only
with that section. For example, where the AD requirement refers to
``all required actions and compliance times,'' compliance with this AD
requirement is not limited to the section titled ``Required Action(s)
and Compliance Time(s)'' in the EASA AD. Service information specified
in EASA AD 2017-0125 that is required for compliance with EASA AD 2017-
0125 will be available on the internet at https://www.regulations.gov
by searching for and locating Docket No. FAA-2020-1123 after the FAA
final rule is published.

Explanation of Retained Requirements

    Although this proposed AD does not explicitly restate the
requirements of AD 2016-23-05, this proposed AD would retain certain
requirements of AD 2016-23-05. Those requirements are referenced in
paragraphs (2) and (5) of EASA AD 2017-0125, which, in turn, is
referenced in paragraph (g) of this proposed AD.

Costs of Compliance

    The FAA estimates that this proposed AD affects 52 helicopters of
U.S. registry. The FAA estimates the following costs to comply with
this proposed AD:

                                      Estimated Costs for Required Actions
----------------------------------------------------------------------------------------------------------------
                                                                                Cost per      Cost on U.S.
                Action                         Labor cost           Parts cost        product        operators
----------------------------------------------------------------------------------------------------------------
Retained actions from AD 2016-23-05...  17 work-hours x $85 per           $1,125          $2,570        $133,640
                                         hour = $1,445.
New proposed actions..................  63 work-hours x 85 per             1,395           6,750         351,000
                                         hour = 5,355.
----------------------------------------------------------------------------------------------------------------

                                      Estimated Costs for Optional Actions
----------------------------------------------------------------------------------------------------------------
                                                                                Cost per
                                  Labor cost                                       Parts cost        product
----------------------------------------------------------------------------------------------------------------
8 work-hours x $85 per hour = $680............................................              $0             $680
----------------------------------------------------------------------------------------------------------------

    The FAA has received no definitive data that would enable the
agency to provide cost estimates for the on-condition actions specified
in this proposed AD.
    According to the manufacturer, some or all of the costs of this
proposed AD may be covered under warranty, thereby reducing the cost
impact on affected operators. The FAA does not control warranty
coverage for affected operators. As a result, the FAA has included all
known costs in this cost estimate.

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) 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 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 removing Airworthiness Directive (AD)
2016-23-05, Amendment 39-18712 (81 FR 85126, November 25, 2016), and
adding the following new AD:

Airbus Helicopters: Docket No. FAA-2020-1123; Project Identifier
MCAI-2020-01294-R.

(a) Comments Due Date

    The FAA must receive comments by January 28, 2021.

(b) Affected Airworthiness Directives (ADs)

    This AD replaces AD 2016-23-05, Amendment 39-18712 (81 FR 85126,
November 25, 2016) (``AD 2016-23-05'').

(c) Applicability

    This AD applies to Airbus Helicopters Model SA-365N1, AS-365N2,
AS 365 N3, SA-366G1, EC 155B, and EC155B1 helicopters, certificated
in any category, all serial numbers.

(d) Subject

    Joint Aircraft System Component (JASC) Code 65, Tail Rotor.

(e) Reason

    This AD was prompted by reports of occurrences of loss of yaw
control due to failure of the tail gearbox (TGB) control rod double
bearing (bearing). This AD was also prompted by the determination
that additional inspections, replacements, and modifications are
necessary to address the unsafe condition. The FAA is issuing this
AD to address damage to the bearing, which could result in end play,
loss of tail rotor pitch control, and subsequent loss of control of
the helicopter.

(f) Compliance

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

(g) Requirements

    Except as specified in paragraph (h) of this AD: Comply with all
required actions and compliance times specified in, and in
accordance with, European Aviation Safety Agency (now European Union
Aviation Safety Agency) (EASA) AD 2017-0125, dated July 21, 2017
(``EASA AD 2017-0125'').

(h) Exceptions to EASA AD 2017-0125

    (1) Where EASA AD 2017-0125 refers to its effective date, this
AD requires using the effective date of this AD.
    (2) Where EASA AD 2017-0125 refers to June 4, 2011 (the
effective date of EASA AD 2011-0105), this AD requires using the
effective date of this AD.
    (3) Where EASA AD 2017-0125 refers to May 25, 2016 (the
effective date of EASA AD 2016-0197R1), this AD requires using the
effective date of this AD.
    (4) The ``Remarks'' section of EASA AD 2017-0125 does not apply
to this AD.
    (5) Where paragraph (2) of EASA AD 2017-0125 requires
inspections (checks) to be done ``in accordance with the
instructions of Paragraph 3.B.1 of the applicable inspection ASB,''
for this AD, those instructions are for reference only and are not
required for the actions in paragraph (2) of EASA AD 2017-0125. The
inspections (checks) required by paragraph (2) of EASA AD 2017-0125
may be performed by the owner/operator (pilot) holding at least a
private pilot certificate and must be entered into the aircraft
records showing compliance with this AD in

accordance with 14 CFR 43.9 (a)(1) through (4) and 14 CFR
91.417(a)(2)(v). The record must be maintained as required by 14 CFR
91.417, 121.380, or 135.439.
    (6) Where paragraph (5) of EASA AD 2017-0125 specifies to
``accomplish the applicable corrective action(s) in accordance with
the instructions of Paragraph 3.B.1 of the applicable inspection
ASB,'' for this AD, a qualified mechanic must add oil to the TGB to
the ``max'' level if the oil level is not at maximum. The
instructions are for reference only and are not required for the
actions in paragraph (5) of EASA AD 2017-0125.
    (7) Where EASA AD 2017-0125 refers to flight hours (FH), this AD
requires using hours time-in-service.
    (8) Where EASA AD 2017-0125 requires action after the last
flight of the day or ``ALF,'' this AD requires those actions before
the first flight of the day.
    (9) Where the service information referred to in EASA AD 2017-
0125 specifies to perform a metallurgical analysis and contact the
manufacturer if collected particles are not clearly characterized,
this AD does not require contacting the manufacturer to determine
the characterization of the particles collected.
    (10) Although service information referenced in EASA AD 2017-
0125 specifies to scrap parts, this AD does not include that
requirement.
    (11) Although service information referenced in EASA AD 2017-
0125 specifies reporting information to Airbus Helicopters and
filling in a ``particle dectection'' follow-up sheet, this AD does
not include those requirements.
    (12) Although service information referenced in EASA AD 2017-
0125 specifies returning certain parts to an approved workshop, this
AD does not include that requirement.
    (13) Where paragraph (6) of EASA AD 2017-0125 refers to ``any
discrepancy,'' for this AD, discrepancies include the presence of
particles and other conditions such as abrasions, scales, flakes,
and splinters.

(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 14 CFR 39.19. In accordance with 14 CFR 39.19,
send your request to your principal inspector or local Flight
Standards District Office, as appropriate. If sending information
directly to the International Validation Branch, send it to the
attention of the person identified in paragraph (j)(2) of this AD.
Information may be emailed to<EMAIL_ADDRESS>Before
using any approved AMOC, notify your appropriate principal
inspector, or lacking a principal inspector, the manager of the
local flight standards district office/certificate holding district
office.

(j) Related Information

    (1) For information about EASA AD 2017-0125, contact the EASA,
Konrad-Adenauer-Ufer 3, 50668 Cologne, Germany; telephone +49 221
8999 000; email<EMAIL_ADDRESS>internet www.easa.europa.eu. You
may find this EASA AD on the EASA website at https://ad.easa.europa.eu. You may view this material at the FAA, Office of
the Regional Counsel, Southwest Region, 10101 Hillwood Pkwy, Room
6N-321, Fort Worth, TX 76177. For information on the availability of
this material at the FAA, call<PHONE_NUMBER>. This material may be
found in the AD docket on the internet at https://www.regulations.gov by searching for and locating Docket No. FAA-
2020-1123.
    (2) For more information about this AD, contact Kathleen
Arrigotti, Aviation Safety Engineer, Large Aircraft Section,
International Validation Branch, FAA, 2200 South 216th St., Des
Moines, WA 98198; telephone and fax<PHONE_NUMBER>; email
<EMAIL_ADDRESS>
    Issued on December 8, 2020.
Gaetano A. Sciortino,
Deputy Director for Strategic Initiatives, Compliance & Airworthiness
Division, Aircraft Certification Service.
[FR Doc. 2020-27416 Filed 12-11-20; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 81, Number 105 (Wednesday, June 1, 2016)]
[Proposed Rules]
[Pages 34940-34944]
[FR Doc No: 2016-12805]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R04-OAR-2016-0011; FRL-9947-18-Region 4]

Air Plan Approval; Tennessee; Revision and Removal of Stage I and
II Gasoline Vapor Recovery Program

AGENCY: Environmental Protection Agency.

ACTION: Proposed rule.

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SUMMARY: The Environmental Protection Agency (EPA) is proposing to
approve changes to the State Implementation Plan (SIP) submitted by the
State of Tennessee through the Tennessee Department of Environment and
Conservation (TDEC) on February 8, 2016, for parallel processing. This
draft SIP revision seeks to lower applicability thresholds for certain
sources subject to Federal Stage I requirements, remove the Stage II
vapor control requirements, and add requirements for decommissioning
gasoline dispensing facilities, as well as requirements for new and
upgraded gasoline dispensing facilities in the Nashville, Tennessee
Area (hereinafter also known as the ``Middle Tennessee Area''). EPA has
preliminarily determined that Tennessee's February 8, 2016, draft SIP
revision is approvable because it is consistent with the Clean Air Act
(CAA or Act).

DATES: Written comments must be received on or before July 1, 2016.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-R04-
OAR-2016-0011 at http://www.regulations.gov. Follow the online
instructions for submitting comments. Once submitted, comments cannot
be edited or removed from Regulations.gov. 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. 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, 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: Kelly Sheckler, Air Regulatory
Management Section, Air Planning and Implementation Branch, Air,
Pesticides and Toxics Management Division, U.S. Environmental
Protection Agency, Region 4, 61 Forsyth Street SW., Atlanta, Georgia
30303-8960. Ms. Sheckler's phone number is<PHONE_NUMBER>. She can also
be reached via electronic mail at<EMAIL_ADDRESS>

SUPPLEMENTARY INFORMATION:

I. What is parallel processing?

    Consistent with EPA regulations found at 40 CFR part 51, Appendix
V, section 2.3.1, for purposes of expediting review of a SIP submittal,
parallel processing allows a state to submit a plan to EPA prior to
actual adoption by the state. Generally, the state submits a copy of
the proposed regulation or other revisions to EPA before conducting its
public hearing. EPA reviews this proposed state action and prepares a
notice of proposed rulemaking. EPA's notice of proposed rulemaking is
published in the Federal Register during the same time frame that the
state is holding its public process. The state and EPA then provide for
concurrent public comment periods on both the state action and federal
action.
    If the revision that is finally adopted and submitted by the state
is changed in aspects other than those identified in the proposed
rulemaking on the parallel process submission, EPA will evaluate those
changes and if necessary and appropriate, issue another notice of
proposed rulemaking. The final rulemaking action by EPA will occur only
after the SIP revision has been adopted by the state and submitted
formally to EPA for incorporation into the SIP.
    On February 8, 2016, the State of Tennessee, through TDEC,
submitted a formal letter request for parallel processing of a draft
SIP revision that the State was already taking through public comment.
TDEC requested parallel processing so that EPA could begin to take
action on its draft SIP revision in advance of the State's submission
of the final SIP revision. As stated above, the final rulemaking action
by EPA will occur only after the SIP revision has been: (1) Adopted by
Tennessee; (2) submitted formally to EPA for incorporation into the
SIP; and (3) evaluated by EPA, including any changes made by the State
after the February 8, 2016, draft was submitted to EPA.

II. Background for Federal Stage I and II Requirements

    Stage I vapor recovery is a type of emission control system that
captures gasoline vapors that are released when gasoline is delivered
to a storage tank. The vapors are returned to the tank truck as the
storage tank is being filled with fuel, rather than released to the
ambient air. Stage II and onboard refueling vapor recovery (ORVR) are
two types of emission control systems that capture fuel vapors from
vehicle gas tanks during refueling. Stage II systems are specifically
installed at gasoline dispensing facilities and capture the refueling
fuel vapors at the gasoline pump nozzle. The system carries the vapors
back to the underground storage tank at the gasoline dispensing
facility to prevent the vapors from escaping to the atmosphere. ORVR
systems are carbon canisters installed directly on automobiles to
capture the fuel vapors evacuated from the gasoline tank before they
reach the nozzle. The fuel vapors captured in the carbon canisters are
then combusted in the engine when the automobile is in operation.
    Under section 182(b)(3) of the CAA, each state was required to
submit a SIP revision to implement Stage II for all ozone nonattainment
areas classified as moderate, serious, severe, or extreme, primarily
for the control of volatile organic compounds (VOC)--a precursor to
ozone formation.\1\ However, section 202(a)(6) of the CAA states that
the section 182(b)(3) Stage II requirements for moderate ozone
nonattainment areas shall not apply after the promulgation of ORVR
standards.\2\ ORVR standards were promulgated by EPA on April 6, 1994.
See 59 FR 16262 and 40 CFR parts 86, 88 and 600. As a result, the CAA
no longer requires moderate areas to impose Stage II controls under
section 182(b)(3), and such areas were able to submit SIP revisions, in
compliance with section 110(l) of the CAA, to remove Stage II
requirements from their SIPs. EPA's policy memoranda related to ORVR,
dated March 9, 1993, and June 23, 1993, provide further guidance on
removing Stage II requirements from certain areas. The policy
memorandum dated March 9, 1993, states that ``[w]hen onboard rules are
promulgated, a State may withdraw its Stage II rules for moderate areas
from the SIP (or from consideration as a SIP revision) consistent with
its obligations under sections 182(b)(3) and 202(a)(6), so long as
withdrawal will not interfere with any other applicable requirement of
the Act.'' \3\
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    \1\ Section 182(b)(3) states that each State in which all or
part of an ozone nonattainment area classified as moderate or above
shall, with respect to that area, submit a SIP revision requiring
owners or operators of gasoline dispensing systems to install and
operate vapor recovery equipment at their facilities. Specifically,
the CAA specifies that the Stage II requirements must apply to any
facility that dispenses more than 10,000 gallons of gasoline per
month or, in the case of an independent small business marketer
(ISBM), as defined in section 324 of the CAA, any facility that
dispenses more than 50,000 gallons of gasoline per month.
Additionally, the CAA specifies the deadlines by which certain
facilities must comply with the Stage II requirements. For
facilities that are not owned or operated by an ISBM, these
deadlines, calculated from the time of State adoption of the Stage
II requirements, are: (1) 6 months for facilities for which
construction began after November 15, 1990, (2) 1 year for
facilities that dispense greater than 100,000 gallons of gasoline
per month, and (3) by November 15, 1994, for all other facilities.
For ISBMs, section 324(a) of the CAA provides the following three-
year phase-in period: (1) 33 percent of the facilities owned by an
ISBM by the end of the first year after the regulations take effect;
(2) 66 percent of such facilities by the end of the second year; and
(3) 100 percent of such facilities after the third year.
    \2\ ORVR is a system employed on gasoline-powered highway motor
vehicles to capture gasoline vapors displaced from a vehicle fuel
tank during refueling events. These systems are required under
section 202(a)(6) of the CAA and implementation of these
requirements began in the 1998 model year. Currently they are used
on all gasoline-powered passenger cars, light trucks and complete
heavy trucks of less than 14,000 pounds GVWR. ORVR systems typically
employ a liquid file neck seal to block vapor escape to the
atmosphere and otherwise share many components with the vehicles'
evaporative emission control system including the onboard diagnostic
system sensors.
    \3\ Memorandum from John S. Seitz, Director, Office of Air
Quality Planning and Standards, to EPA Regional Air Directors,
Impact of the Recent Onboard Decision on Stage II Requirements in
Moderate Areas (March 9, 1993), available at: http://www.epa.gov/ttn/naaqs/aqmguide/collection/cp2/19930309_seitz_onboard_impact_stage2_.pdf.
---------------------------------------------------------------------------

    CAA section 202(a)(6) also provides discretionary authority to the
EPA Administrator to, by rule, revise or waive the section 182(b)(3)
Stage II requirement for serious, severe, and extreme ozone
nonattainment areas after the Administrator determines that ORVR is in
widespread use throughout the motor vehicle fleet. On May 16, 2012, in
a rulemaking entitled ``Air Quality: Widespread Use for Onboard
Refueling Vapor Recovery and Stage II Waiver,'' EPA determined that
ORVR technology is in widespread use throughout the motor vehicle fleet
for purposes of controlling motor vehicle refueling emissions. See 77
FR 28772. By that action, EPA waived the requirement for states to
implement Stage II gasoline vapor recovery systems at gasoline
dispensing facilities in nonattainment areas classified as serious and
above for the ozone NAAQS. Effective May 16, 2012, states implementing
mandatory Stage II programs under section 182(b)(3) of the CAA were
allowed to submit SIP revisions to remove this program. See 40 CFR
51.126(b).\4\ On April 7, 2012, EPA released the guidance entitled
``Guidance on Removing Stage II Gasoline Vapor Control Programs from

State Implementation Plans and Assessing Comparable Measures'' for
states to consider in preparing their SIP revisions to remove existing
Stage II programs from state implementation plans.\5\
---------------------------------------------------------------------------

    \4\ As noted above, EPA found, pursuant to CAA section
202(a)(6), that ORVR systems are in widespread use in the motor
vehicle fleet and waived the CAA section 182(b)(3) Stage II vapor
recovery requirement for serious and higher ozone nonattainment
areas on May 16, 2012. Thus, in its implementation rule for the 2008
ozone NAAQS, EPA removed the section 182(b)(3) Stage II requirement
from the list of applicable requirements in 40 CFR 51.1100(o). See
80 FR 12264 for additional information.
    \5\ This guidance document is available at: http://www.epa.gov/groundlevelozone/pdfs/20120807guidance.pdf.
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III. Tennessee's Stage I and II Vapor Recovery Requirements for the
Middle Tennessee Area

    On November 6, 1991, EPA designated and classified the Nashville
Area (Davidson, Rutherford, Sumner, Williamson and Wilson counties) as
a moderate ozone nonattainment area for the 1-hour ozone NAAQS. See 56
FR 56694, 56829. As mentioned above, the ``moderate'' classification
triggered various statutory requirements for this Area, including the
requirement pursuant to section 182(b)(3) of the CAA for the Area to
require all owners and operators of gasoline dispensing systems to
install and operate a system for gasoline vapor recovery of emissions
from the fueling of motor vehicles known as ``Stage II.'' \6\ On
November 5, 1992, May 18, 1993, and July 6, 1993, the State of
Tennessee submitted SIP revisions to EPA for Stage I and II vapor
recovery in the Nashville Area.\7\
---------------------------------------------------------------------------

    \6\ As discussed above, Stage II is a system designed to capture
displaced vapors that emerge from inside a vehicle's fuel tank when
gasoline is dispensed into the tank. There are two basic types of
Stage II systems, the balance type and the vacuum assist type.
    \7\ ``Gasoline Dispensing Facility, Stage 1'' under Section 7-
13, covering Nashville/Davidson County was first submitted on
February 16, 1990 for EPA approval into the SIP and was approved
March 11, 1991. See 56 FR 10171. The last revision for regulations
related to Nashville/Davidson County was submitted on July 3, 1991,
and later approved by EPA on June 26, 1992. See 57 FR 28625.
---------------------------------------------------------------------------

    On February 9, 1995, EPA approved Tennessee's November 5, 1992, May
18, 1993, and July 6, 1993, SIP revision containing Tennessee Air
Pollution Control Regulations (TAPCR) rule 1200-03-18-.24, Gasoline
Dispensing Facilities, Stage I and Stage II Vapor Recovery which
regulates the emissions of VOCs from petroleum product storage and
distribution network. 60 FR 7713.\8\ TAPCR 1200-03-18-.24 includes
requirements for control of VOC emissions from filling of certain
gasoline storage tanks in several Tennessee counties using Stage I
vapor recovery systems. Subsequently, on January 10, 2008, EPA
promulgated similar requirements for Stage I vapor recovery as 40 CFR
part 63, subpart CCCCCC. 73 FR 1945.
---------------------------------------------------------------------------

    \8\ Revisions to this rule were subsequently approved by EPA on
April 14, 1997, and August 26, 2005.
---------------------------------------------------------------------------

    On November 14, 1994, TDEC submitted to EPA a request (later
supplemented on August 9, 1995, and January 19, 1996) to redesignate
the Middle Tennessee Area to attainment for the 1-hour ozone standard
and an associated maintenance plan. The maintenance plan, as required
under section 175A of the CAA, showed that nitrogen oxides and VOC
emissions in the Area would remain below the 1994 ``attainment year''
levels through the greater than ten-year period from 1994-2006. In
making these projections, TDEC factored in the emissions benefit of the
Area's Stage II program, thereby maintaining this program as an active
part of its 1-hour ozone SIP. The redesignation request and maintenance
plan was approved by EPA, effective October 30, 1996. See 61 FR 55903.
Subsequently, the maintenance plan was extended by TDEC to 2016, and
this extension was approved by EPA, effective January 3, 2006. See 70
FR 65838.

IV. Analysis of the State's Submittal

    On February 8, 2016, Tennessee submitted a draft SIP revision to
EPA seeking modifications of the Stage II and Stage I requirements in
the State. First, in relation to Stage II, TDEC seeks the removal of
the Stage II vapor recovery requirements from TAPCR 1200-03-18-.24
through the addition of requirements for decommissioning, and the phase
out of the Stage II vapor recovery systems over a 3-year period from
January 1, 2016, to January 1, 2019, in Davidson, Rutherford, Sumner,
Williamson and Wilson Counties. Second, TDEC seeks to amend the Stage I
requirements for gasoline dispensing facilities by adopting by
reference the Federal requirements of 40 CFR part 63, subpart CCCCCC
and removing most of the State-specific language for Stage I vapor
recovery.\9\ Below are additional details regarding EPA's rationale for
the actions proposed in today's rulemaking in relation to Tennessee's
requested changes.
---------------------------------------------------------------------------

    \9\ However, any gasoline dispensing facility with a monthly
throughput of 10,000 gallons or more of gasoline that is located in
Anderson, Blount, Carter, Cheatham, Davidson, Dickson, Fayette,
Hamilton, Hawkins, Haywood, Jefferson, Knox Loudon, Marion, Meigs,
Montgomery, Putnam, Robertson, Rutherford, Sevier, Shelby, Sullivan,
Sumner, Tipton, Unicoi, Union, Washington, Williamson, or Wilson
Counties will be subject to expanded requirements under subpart
CCCCCC.
---------------------------------------------------------------------------

A. Analysis of Changes to Tennessee's Stage II Requirements for Middle
Tennessee

    EPA's primary consideration in determining the approvability of
Tennessee's request regarding removal of the Stage II program in the
Middle Tennessee Area is whether this requested action complies with
section 110(l) of the CAA.\10\ Section 110(l) requires that a revision
to the SIP not interfere with any applicable requirement concerning
attainment and reasonable further progress (as defined in section 171),
or any other applicable requirement of the Act. EPA evaluates each
section 110(l) noninterference demonstration on a case-by-case basis,
considering the circumstances of each SIP revision. EPA interprets
110(l) as applying to all NAAQS that are in effect, including those
that have been promulgated but for which the EPA has not yet made
designations. The degree of analysis focused on any particular NAAQS in
a noninterference demonstration varies depending on the nature of the
emissions associated with the proposed SIP revision. EPA's analysis of
Tennessee's February 8, 2016, SIP revision pursuant to section 110(l)
is provided below.
---------------------------------------------------------------------------

    \10\ CAA section 193 is not relevant because Tennessee's Stage
II rule was not included in the SIP before the 1990 CAA amendments.
---------------------------------------------------------------------------

    In its February 8, 2016, draft SIP revision, TDEC used EPA's
guidance entitled ``Guidance on Removing Stage II Gasoline Vapor
Control Programs from State Implementation Plans and Assessing
Comparable Measures'' to conduct a series of calculations to determine
the potential impact on air quality of removing the Stage II
program.\11\ Tennessee's analysis focused on VOC emissions because, as
mentioned above, Stage II requirements affect VOC emissions and because
VOCs are a precursor for ozone formation.\12\

The results of TDEC's analysis are provided in the table below.
---------------------------------------------------------------------------

    \11\ EPA, Guidance on Removing Stage II Gasoline Vapor Control
Programs from State Implementation Plans and Assessing Comparable
Measures, EPA-457/B-12-001 (Aug. 7, 2012), available at: https://www.epa.gov/ozone-pollution/ozone-stage-two-vapor-recovery-rule-and-guidance. This guidance document notes that ``the potential emission
control losses from removing Stage II VRS are transitional and
relatively small. ORVR-equipped vehicles will continue to phase in
to the fleet over the coming years and will exceed 80 percent of all
highway gasoline vehicles and 85 percent of all gasoline dispensed
during 2015. As the number of these ORVR-equipped vehicles increase,
the control attributed to Stage II VRS will decrease even further,
and the potential foregone Stage II VOC emission reductions are
generally expected to be no more than one percent of the VOC
inventory in the area.''
    \12\ Several counties in Middle Tennessee are currently
designated nonattainment for the 1997 Annual fine particulate matter
(PM2.5) standard. While VOC is one of the precursors for
particulate matter (NAAQS) formation, studies have indicated that,
in the southeast, emissions of direct PM2.5 and the
precursor sulfur oxides are more significant to ambient summertime
PM2.5 concentrations than emissions of nitrogen oxides
and anthropogenic VOC. See, e.g., Quantifying the sources of ozone,
fine particulate matter, and regional haze in the Southeastern
United States, Journal of Environmental Engineering (June 24, 2009),
available at: https://www.deepdyve.com/lp/elsevier/quantifying-the-sources-of-ozone-fine-particulate-matter-and-regional-yYzp0F1KBu.

     Table 1--VOC Emissions per Ozone Season From Stage II Controls
------------------------------------------------------------------------
                                                         VOC emissions
                         Year                           reduction (tons
                                                           per year)
------------------------------------------------------------------------
2010.................................................             510.60
2011.................................................             397.39
2012.................................................             281.97
2013.................................................             188.45
2014.................................................             107.28
2015.................................................              38.62
2016.................................................             -20.50
2017.................................................             -67.19
2018.................................................            -106.81
2019.................................................            -137.24
2020.................................................            -154.83
------------------------------------------------------------------------

    The removal of Stage II vapor recovery systems in the five-county
Middle Tennessee area starting in 2016 will result in a VOC emission
decrease, with emission reduction benefits increasing over time.
Conversely, as Table 1 shows, if Stage II requirements are kept in
place, an increase in VOC emissions will occur beyond 2015, and it will
become detrimental to air quality in the five-county Middle Tennessee
area to keep Stage II systems in operation.\13\
---------------------------------------------------------------------------

    \13\ The emissions-reduction disbenefit associated with
continued implementation of Stage II requirements is due to the
incompatibility of some Stage II and ORVR systems. Compatibility
problems can result in an increase in emissions from the underground
storage tank (UST) vent pipe and other system fugitive emissions
related to the refueling of ORVR vehicles with some types of vacuum
assist-type Stage II systems. This occurs during refueling an ORVR
vehicle when the vacuum assist system draws fresh air into the UST
rather than an air vapor mixture from the vehicle fuel tank. Vapor
flow from the vehicle fuel tank is blocked by the liquid seal in the
fill pipe which forms at a level deeper in the fill pipe than can be
reached by the end of the nozzle spout. The fresh air drawn into the
UST enhances gasoline evaporation in the UST which increases
pressure in the UST. Unless it is lost as a fugitive emission, any
tank pressure in excess of the rating of the pressure/vacuum valve
is vented to the atmosphere over the course of a day. See EPA,
Guidance on Removing Stage II Gasoline Vapor Control Programs from
State Implementation Plans and Assessing Comparable Measures, EPA-
457/B-12-001 (Aug. 7, 2012), available at: https://www.epa.gov/ozone-pollution/ozone-stage-two-vapor-recovery-rule-and-guidance.
Thus, as ORVR technology is phased in, the amount of emission
control that is gained through Stage II systems decreases.
---------------------------------------------------------------------------

    The affected sources covered by Tennessee's Stage II vapor recovery
requirements are sources of VOCs. Other criteria pollutants (carbon
monoxide, sulfur dioxide, nitrogen dioxide, particulate matter, and
lead) are not emitted by gasoline dispensing facilities and will not be
affected by the removal of Stage II controls.
    The proposed revisions to TAPCR 1200-03-18-.24 include that
gasoline dispensing facilities located in Davidson, Rutherford, Sumner,
Williamson, and Wilson counties shall decommission and remove the
systems no later than 3 years from the effective date of this rule.
Tennessee noted in its submission that procedures to decommission and
remove systems will be conducted in accordance with Petroleum Equipment
Institute (PEI) guidance, ``Recommended Practices for Installation and
Testing of Vapor Recovery Systems at Vehicle Refueling Sites,'' PEI/
RP300-09.
    EPA is proposing to determine that TDEC's technical analysis is
consistent with EPA's guidance on removing Stage II requirements from a
SIP, including those provisions related to the decommissioning and
phasing out of the Stage II requirements for the Middle Tennessee Area.
EPA is also making the preliminary determination that Tennessee's SIP
revision is consistent with the CAA and with EPA's regulations related
to removal of Stage II requirements from the SIP and that these changes
will not interfere with any applicable requirement concerning
attainment or any other applicable requirement of the CAA, and
therefore satisfy section 110(l).

B. Analysis of Changes to Tennessee's Stage I Requirements

    Tennessee's Stage I requirements are in TAPCR 1200-03-18-.24, and
provide for the control of VOC emissions from filling stations of
certain gasoline storage tanks in Blount, Carter, Cheatham, Davidson,
Dickinson, Fayette, Hamilton, Hawkins, Haywood, Jefferson, Knox,
Loudon, Marion, Meigs, Montgomery, Putnam, Robertson, Rutherford,
Sullivan, Sumner, Tipton, Unicoi, Union, Washington, Williamson, and
Wilson Counties. EPA promulgated similar requirements for Stage I vapor
recovery at 40 CFR part 63, subpart CCCCCC. To eliminate overlap of
State and Federal requirements, Tennessee proposes to adopt by
reference 40 CFR part 63, subpart CCCCCC and remove the Stage I SIP
requirements of TAPCR 1200-03-18-.24. Tennessee provided a section
110(l) demonstration that includes a comparison demonstrating the
equivalence of State and Federal Stage I requirements, i.e., showing
that the State requirements will be as stringent as or more stringent
than the comparable Federal requirements. Tennessee's submittal
proposes to lower the applicability threshold of the Federal
requirements to apply to smaller facilities based on monthly
throughput, rather than the equivalent Federal requirements for the
subject counties listed above. Thus the State rule (1200-03-18-.24(1))
is more stringent than the Federal Rule.
    EPA has preliminarily determined that these changes to Tennessee's
Stage I requirements will not interfere with any applicable requirement
concerning attainment or any other applicable requirement of the CAA,
and therefore satisfy section 110(l), because they remove obsolete
language due, in part, to superseding Federal requirements in 40 CFR
part 63, subpart CCCCCC.

V. Incorporation by Reference

    In this rule, EPA is proposing to include in a final EPA rule
regulatory text that includes incorporation by reference. In accordance
with requirements of 1 CFR 51.5, EPA is proposing to incorporate by
reference TDEC Regulation TAPCR 1200-03-18-.24, Gasoline Dispensing
Facilities. EPA has made, and will continue to make, these documents
generally available electronically through www.regulations.gov and/or
in hard copy at the EPA Region 4 office (see the ADDRESSES section of
this preamble for more information).

VI. Proposed Action

    EPA is proposing to approve Tennessee's February 8, 2016, draft SIP
revision that changes Tennessee Gasoline Dispensing Facilities, Stage I
and II Vapor Recovery, TAPCR rule 1200-03-18-.24. to: (1) Allow for the
removal of the Stage II requirement and the orderly decommissioning of
Stage II equipment; and (2) incorporate by reference Federal rule 40
CFR part 63, subpart CCCCCC, and remove certain non-state-specific
requirements for the Stage I. EPA is proposing this approval because
the Agency has made the preliminary determination that Tennessee's
February 8, 2016, draft SIP revision related to the State's Stage I and
II rule is consistent with the CAA and with EPA's regulations and
guidance.

VII. 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.

See 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in reviewing SIP
submissions, EPA's role is to approve state choices, provided that they
meet the criteria of the CAA. Accordingly, this proposed action merely
proposes to approve state law as meeting federal requirements and does
not impose additional requirements beyond those imposed by state law.
For that reason, this proposed action:
     Is not a ``significant regulatory action'' subject to
review by the Office of Management and Budget under Executive Orders
12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21,
2011);
     does not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);
     is certified as not having a significant economic impact
on a substantial number of small entities under the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.);
     does not contain any unfunded mandate or significantly or
uniquely affect small governments, as described in the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4);
     does not have Federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999);
     is not an economically significant regulatory action based
on health or safety risks subject to Executive Order 13045 (62 FR
19885, April 23, 1997);
     is not a significant regulatory action subject to
Executive Order 13211 (66 FR 28355, May 22, 2001);
     is not subject to requirements of Section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272
note) because application of those requirements would be inconsistent
with the CAA; and
     does not provide EPA with the discretionary authority to
address, as appropriate, disproportionate human health or environmental
effects, using practicable and legally permissible methods, under
Executive Order 12898 (59 FR 7629, February 16, 1994).
    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 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.

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Incorporation by
reference, Nitrogen dioxide, Ozone, Reporting and recordkeeping
requirements, Volatile organic compounds.

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

    Dated: May 19, 2106.
Heather McTeer Toney,
Regional Administrator, Region 4.
[FR Doc. 2016-12805 Filed 5-31-16; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register Volume 81, Number 29 (Friday, February 12, 2016)]
[Rules and Regulations]
[Pages 7452-7454]
[FR Doc No: 2016-02878]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 878

[Docket No. FDA-2016-N-0237]

Medical Devices; General and Plastic Surgery Devices;
Classification of the Scalp Cooling System To Reduce the Likelihood of
Chemotherapy-Induced Alopecia

AGENCY: Food and Drug Administration, HHS.

ACTION: Final order.

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SUMMARY: The Food and Drug Administration (FDA) is classifying the
scalp cooling system to reduce the likelihood of chemotherapy-induced
alopecia into class II (special controls). The special controls that
will apply to the device are identified in this order and will be part
of the codified language for the scalp cooling system to reduce the
likelihood of chemotherapy-induced alopecia's classification. The
Agency is classifying the device into class II (special controls) in
order to provide a reasonable assurance of safety and effectiveness of
the device.

DATES: This order is effective February 12, 2016. The classification
was applicable on December 8, 2015.

FOR FURTHER INFORMATION CONTACT: Neil Ogden, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. G414, Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

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 part 807 (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) of
the FD&C Act. 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) of the FD&C Act 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.
    On March 6, 2015, Target Health, Inc. (on behalf of Dignitana AB)
submitted a request for classification of the DigniCapTM
Scalp Cooling System under section 513(f)(2) of the FD&C Act. The
manufacturer recommended that the device be classified into class II
(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 II if general controls by themselves are
insufficient to provide reasonable assurance of safety and
effectiveness, but there is sufficient information to establish special
controls to provide reasonable assurance of the safety and
effectiveness of the device for its intended use. After review of the
information submitted in the request and the medical literature, if
applicable, FDA determined that the device can be classified into class
II with the establishment of special controls. FDA believes these
special controls will provide reasonable assurance of the safety and
effectiveness of the device.
    Therefore, on December 8, 2015, FDA issued an order to the
requestor classifying the device into class II. FDA is codifying the
classification of the device by adding Sec.  878.4360 (21 CFR
878.4360).
    Following the effective date of this final classification order,
any firm submitting a premarket notification (510(k)) for a scalp
cooling system to reduce the likelihood of chemotherapy-induced
alopecia will need to comply with the special controls named in this
final order.
    The device is assigned the generic name scalp cooling system to
reduce the likelihood of chemotherapy-induced alopecia, and it is
identified as a scalp cooling system to reduce the likelihood of
chemotherapy-induced alopecia intended to reduce the frequency and
severity of alopecia during chemotherapy in which alopecia-inducing
chemotherapeutic agents are used. The device is a prescription device.
    FDA has identified the following risks to health associated with
this type of device and the measures required to mitigate these risks:

 Table 1--Scalp Cooling System To Reduce the Likelihood of Chemotherapy-
             Induced Alopecia Risks and Mitigation Measures
------------------------------------------------------------------------
            Identified risk                     Mitigation measure
------------------------------------------------------------------------
Thermal Tissue Damage..................  Non-clinical Performance
                                          Testing.
                                         Software Verification,
                                          Validation, and Hazard
                                          Analysis Labeling.
Electromagnetic Interference/Electrical  Electromagnetic Compatibility
 Shock.                                   and Electrical Testing
                                          Labeling.
Adverse Tissue Reaction................  Biocompatibility.
Increased Risk of Scalp Metastases.....  Labeling.
                                         Patient Labeling.
Use Error..............................  Labeling.
Scalp Pain, Headache, and Chills.......  Labeling.
                                         Patient Labeling.
------------------------------------------------------------------------

    FDA believes that the special controls in Sec.  878.4360(b)(1)
through (6), in addition to the general controls, address these risks
to health and provide reasonable assurance of safety and effectiveness.
    Scalp cooling systems to reduce the likelihood of chemotherapy-
induced alopecia are prescription devices restricted to patient use
only upon the authorization of a practitioner licensed by law to
administer or use the device; see 21 CFR 801.109 (Prescription
devices).
    Section 510(m) of the FD&C Act provides that FDA may exempt a class
II device from the premarket notification requirements under section
510(k) of the FD&C Act, if FDA determines that premarket notification
is not necessary to provide reasonable assurance of the safety and
effectiveness of the device. For this type of device, FDA has
determined that premarket notification is necessary to provide
reasonable assurance of the safety and effectiveness of the device.
Therefore, this device type is not exempt from premarket notification
requirements. Persons who intend to market this type of device must
submit to FDA a premarket notification, prior to marketing the device,
which contains information about the scalp cooling system to reduce the
likelihood of chemotherapy-induced alopecia they intend to market.

II. Analysis of 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 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
part 807, subpart E, regarding premarket notification submissions have
been approved under OMB control number 0910-0120, and 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 is on display in the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852, and is available for viewing by
interested persons between 9 a.m. and 4 p.m., Monday through Friday; it
is also available electronically at http://www.regulations.gov.

1. DEN150010: De novo request per 513(f)(2) from Target Health, Inc.
(on behalf of Dignitana AB), dated March 6, 2015.

List of Subjects in 21 CFR Part 878

    Medical devices.

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

PART 878--GENERAL AND PLASTIC SURGERY DEVICES

0
1. The authority citation for 21 CFR part 878 continues to read as
follows:

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

0
2. Add Sec.  878.4360 to subpart E to read as follows:

Sec.  878.4360  Scalp cooling system to reduce the likelihood of
chemotherapy-induced alopecia.

    (a) Identification. A scalp cooling system to reduce the likelihood
of chemotherapy-induced alopecia is a prescription device intended to
reduce

the frequency and severity of alopecia during chemotherapy in which
alopecia-inducing chemotherapeutic agents are used.
    (b) Classification--Class II (special controls). The special
controls for this device are:
    (1) Non-clinical performance testing must demonstrate that the
device meets all design specifications and performance requirements,
and that the device performs as intended under anticipated conditions
of use. This information must include testing to demonstrate accuracy
of the temperature control mechanism.
    (2) Performance testing must demonstrate the electromagnetic
compatibility and electrical safety of the device.
    (3) Software verification, validation, and hazard analysis must be
performed.
    (4) The patient contacting components of the device must be
demonstrated to be biocompatible. Material names must be provided.
    (5) Labeling must include the following:
    (i) A statement describing the potential risk of developing scalp
metastasis.
    (ii) Information on the patient population and chemotherapeutic
agents/regimen for which the device has been demonstrated to be
effective.
    (iii) A summary of the non-clinical and/or clinical testing
pertinent to use of the device.
    (iv) A summary of the device technical parameters, including
temperature cooling range and duration of cooling.
    (v) A summary of the device- and procedure-related adverse events
pertinent to use of the device.
    (vi) Information on how the device operates and the typical course
of treatment.
    (6) Patient labeling must be provided and must include:
    (i) Relevant contraindications, warnings, precautions, and adverse
effects/complications.
    (ii) Information on how the device operates and the typical course
of treatment.
    (iii) Information on the patient population for which there is
clinical evidence of effectiveness.
    (iv) The potential risks and benefits associated with use of the
device.
    (v) Postoperative care instructions.
    (vi) A statement describing the potential risk of developing scalp
metastasis.

    Dated: February 8, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-02878 Filed 2-11-16; 8:45 am]
BILLING CODE 4164-01-P