[Federal Register Volume 80, Number 65 (Monday, April 6, 2015)]
[Rules and Regulations]
[Pages 18307-18310]
[FR Doc No: 2015-07815]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 876

[Docket No. FDA-2015-N-0804]

Medical Devices; Gastroenterology-Urology Devices; Classification
of the Urethral Insert With Pump for Bladder Drainage

AGENCY: Food and Drug Administration, HHS.

ACTION: Final order.

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SUMMARY: The Food and Drug Administration (FDA) is classifying the
urethral insert with pump for bladder drainage 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 urethral insert with pump for bladder drainage'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 April 6, 2015. The classification was
applicable on October 14, 2014.

FOR FURTHER INFORMATION CONTACT: John Baxley, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. G210, 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).
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 October 25, 2013, Vesiflo, Inc., submitted a request for
classification of the inFlowTM Intraurethral Valve-Pump and
Activator 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). 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, FDA determined that the device can be classified into class II
with the establishment of special controls. FDA believes these special
controls, in addition to general controls, will provide reasonable
assurance of the safety and effectiveness of the device.
    Therefore, on October 14, 2014, FDA issued an order to the
requestor classifying the device into class II. FDA is codifying the
classification of the device by adding Sec.  876.5140.
    Following the effective date of this final classification order,
any firm submitting a premarket notification (510(k)) for a urethral
insert with pump for bladder drainage will need to comply with the
special controls named in this final order. The device is assigned the
generic name urethral insert with pump for bladder drainage, and it is
identified as a catheter-like device with internal pump mechanism that
is placed in the urethra. Under patient control the internal pump draws
urine out of the bladder when voiding is desired, and blocks urine flow
when continence is desired. The device is intended for use by women who
cannot empty their bladder due to impaired detrusor contractility.
    FDA has identified the following risks to health associated
specifically with this type of device, as well as the measures required
to mitigate these risks in table 1.

              Table 1--Urethral Insert With Pump for Bladder Drainage Risks and Mitigation Measures
----------------------------------------------------------------------------------------------------------------
               Identified risk                                        Mitigation measure
----------------------------------------------------------------------------------------------------------------
Adverse Tissue Reaction.....................  Biocompatibility Testing.
Infection...................................  Sterilization Validation.
                                              Clinical Testing.
                                              Labeling.
Reflux or Renal Damage......................  Non-Clinical (Bench) Testing.
                                              Clinical Testing.
                                              Labeling.
Urethral/Bladder Wall Trauma................  Clinical Testing.
                                              Labeling.
Urinary Frequency/Urgency...................  Clinical Testing.
                                              Labeling.
Device Encrustation.........................  Non-Clinical (Bench) Testing.
                                              Labeling.
Device Migration............................  Non-Clinical (Bench) Testing.
                                              Clinical Testing.
Device Malfunction..........................  Non-Clinical (Bench) Testing.
                                              Labeling.
Urine Leakage...............................  Non-Clinical (Bench) Testing.
                                              Labeling.
Discomfort..................................  Clinical Testing.
                                              Labeling.
----------------------------------------------------------------------------------------------------------------

    FDA believes that the following special controls, in combination
with the general controls, address these risks to health and provide
reasonable assurance of the safety and effectiveness:
     The elements of the device that may contact the urinary
tract must be demonstrated to be biocompatible.
     Performance data must demonstrate the sterility of the
device components that contact the urinary tract.
     Performance data must support shelf life by demonstrating
continued sterility of the device (or the sterile components), package
integrity, and device functionality over the requested shelf life.

     Non-clinical testing data must demonstrate that the device
performs as intended under anticipated conditions of use. The following
performance characteristics must be tested:
    [cir] Urine flow rate testing.
    [cir] Valve integrity testing.
    [cir] Bladder neck retention force testing.
    [cir] Pump/valve endurance testing.
    [cir] Encrustation testing.
    [cir] Remote control reliability, mechanical integrity, and battery
life testing.
     Clinical testing must demonstrate safe and effective use,
document the device acceptance rate and the adverse event profile
associated with clinical use, and demonstrate that the device performs
as intended under anticipated conditions of use.
     Labeling must include:
    [cir] Specific instructions, contraindications, warnings, cautions,
limitations, and the clinical training needed for the safe use of the
device.
    [cir] Statement of the maximum insert indwelling period.
    [cir] Information on the patient education and support program
prior to and during initial device use.
    [cir] Information on the patient population for which the device
has been demonstrated to be safe and effective.
    [cir] Information on how the device operates and the recommended
treatment regimen.
    [cir] A detailed summary of the device- and procedure-related
complications or adverse events pertinent to use of the device.
    [cir] An expiration date/shelf life.
     Patient labeling must be provided and must include:
    [cir] Relevant contraindications, warnings, precautions, and
adverse events/complications.
    [cir] Information on how the device operates and the recommended
treatment regimen.
    [cir] Information on the patient education and support program
prior to and during initial device use.
    [cir] Information on the patient population for which there is
clinical evidence of safety and effectiveness.
    [cir] The potential risks and benefits associated with the use of
the device.
    [cir] Post-insertion care instructions.
    [cir] Alternative treatments.
    Urethral inserts with pump for bladder drainage are prescription
devices restricted to patient use only upon the authorization of a
practitioner licensed by law to administer or use the device; 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.
    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), 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
urethral inserts with pump for bladder drainage they intend to market.

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 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 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 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. DEN130044: De Novo Request per 513(f)(2) from Vesiflo, Inc.,
dated October 25, 2013.

List of Subjects in 21 CFR Part 876

    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
876 is amended as follows:

PART 876--GASTROENTEROLOGY-UROLOGY DEVICES

0
1. The authority citation for 21 CFR part 876 continues to read as
follows:

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

0
2. Add Sec.  876.5140 to subpart F to read as follows:

Sec.  876.5140  Urethral insert with pump for bladder drainage.

    (a) Identification. A urethral insert with pump for bladder
drainage is a catheter-like device with internal pump mechanism that is
placed in the urethra. Under patient control the internal pump draws
urine out of the bladder when voiding is desired, and blocks urine flow
when continence is desired. The device is intended for use by women who
cannot empty their bladder due to impaired detrusor contractility.
    (b) Classification. Class II (special controls). The special
controls for this device are:
    (1) The elements of the device that may contact the urinary tract
must be demonstrated to be biocompatible.
    (2) Performance data must demonstrate the sterility of the device
components that contact the urinary tract.
    (3) Performance data must support shelf life by demonstrating
continued sterility of the device (or the sterile components), package
integrity, and device functionality over the requested shelf life.
    (4) Non-clinical testing data must demonstrate that the device
performs as intended under anticipated conditions of use. The following
performance characteristics must be tested:
    (i) Urine flow rate testing.
    (ii) Valve integrity testing.
    (iii) Bladder neck retention force testing.
    (iv) Pump/valve endurance testing.
    (v) Encrustation testing.
    (vi) Remote control reliability, mechanical integrity, and battery
life testing.
    (5) Clinical testing must demonstrate safe and effective use,
document the device acceptance rate and the adverse event profile
associated with clinical use, and demonstrate that the device performs
as intended under anticipated conditions of use.

    (6) Labeling must include:
    (i) Specific instructions, contraindications, warnings, cautions,
limitations, and the clinical training needed for the safe use of the
device.
    (ii) Statement of the maximum insert indwelling period.
    (iii) Information on the patient education and support program
prior to and during initial device use.
    (iv) Information on the patient population for which the device has
been demonstrated to be safe and effective.
    (v) Information on how the device operates and the recommended
treatment regimen.
    (vi) A detailed summary of the device- and procedure-related
complications or adverse events pertinent to use of the device.
    (vii) An expiration date/shelf life.
    (7) Patient labeling must be provided and must include:
    (i) Relevant contraindications, warnings, precautions, and adverse
events/complications.
    (ii) Information on how the device operates and the recommended
treatment regimen.
    (iii) Information on the patient education and support program
prior to and during initial device use.
    (iv) Information on the patient population for which there is
clinical evidence of safety and effectiveness.
    (v) The potential risks and benefits associated with the use of the
device.
    (vi) Post-insertion care instructions.
    (vii) Alternative treatments.

    Dated: March 31, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-07815 Filed 4-3-15; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register: February 21, 2008 (Volume 73, Number 35)]
[Rules and Regulations]
[Page 9450-9451]
[DOCID:fr21fe08-8]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2008-0062; Airspace Docket No. 08-ANE-93]

Establishment of Class E Airspace; Stonington, ME

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Direct final rule, request for comments.

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SUMMARY: This action establishes Class E Airspace at Stonington, ME to
support a new Area Navigation (RNAV) Global Positioning System (GPS)
Special Instrument Approach Procedure (IAP) that has been developed for
medical flight operations into Stonington Municipal Airport. This
action enhances the safety and management of Instrument Flight Rule
(IFR) operations by providing that required controlled airspace to
support his approach around Stonington, ME.

DATES: Effective 0901 UTC, June 5, 2008. The Director of the Federal
Register approves this incorporation by reference action under title 1,
Code of Federal Regulations, part 51, subject to the annual revision of
FAA Order 7400.9 and publication of conforming amendments. Comments for
inclusion in the Rules Docket must be received on or before April 7,
2008.

ADDRESSES: Send comments on this rule to: U.S. Department of
Transportation, Docket Operations, West Building, Ground Floor, Room
W12-140, 1200 New Jersey Avenue, SE., Washington, DC 20590-0001;
Telephone: 1-800-647-5527; Fax:<PHONE_NUMBER>. You must identify the
Docket Number FAA-2008-0062; Airspace Docket No. 08-ANE-93, at the
beginning of your comments. You may also submit and review received
comments through the Internet at http://www.regulations.gov.

    You may review the public docket containing the rule, any comments
received, and any final disposition in person in the Dockets Office
(see ADDRESSES section for address and phone number) between 9 a.m. and
5 p.m., Monday through Friday, except Federal Holidays.
    An informal docket may also be examined during normal business
hours at the office of the Eastern Service Center, Federal Aviation
Administration, Room 210, 1701 Columbia Avenue, College Park, Georgia
30337.

FOR FURTHER INFORMATION CONTACT: Melinda Giddens, System Support Group,
Eastern Service Center, Federal Aviation Administration, P.O. Box
20636, Atlanta, Georgia 30320; telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

The Direct Final Rule Procedure

    The FAA anticipates that this regulation will not result in adverse
or negative comments, and, therefore, issues it as a direct final rule.
The FAA has determined that this rule only involves an established body
of technical regulations for which frequent and routine amendments are
necessary to keep them operationally current. Unless a written adverse
or negative comment or a written notice of intent to submit an adverse
or negative comment is received within the comment period, the
regulation will become effective on the date specified above. After the
close of the comment period, the FAA will publish a document in the
Federal Register indicating that no adverse or negative comments were
received and confirming the effective date. If the FAA receives, within
the comment period, an adverse or negative comment, or written notice
of intent to submit such a comment, a document withdrawing the direct
final rule will be published in the Federal Register, and a notice of
proposed rulemaking may be published with a new comment period.

Comments Invited

    Although this action is in the form of a direct final rule, and was
not preceded by a notice of proposed rulemaking, interested persons are
invited to comment on this rule by submitting such written data, views,
or arguments as they may desire. An electronic copy of this document
may be downloaded from and comments may be submitted and reviewed at
http://www.regulations.gov Recently published rulemaking documents can also be accessed through the FAA's Web page at http://www.faa.gov. or

the Federal Register's Web page at http://www.gpoaccess.gov/fr/index.html.
 Communications should identify both docket numbers and be

submitted in triplicate to the address specified under the caption
ADDRESSES above or through the website. All communications received on
or before the closing date for comments will be considered, and this
rule may be amended or withdrawn in light of the comments received.
    Comments are specifically invited on the overall regulatory,
economic, environmental, and energy aspects of the rule that might
suggest a need to modify the rule. Factual information that supports
the commenter's ideas and suggestions is extremely helpful in
evaluating the effectiveness of this action and determining whether
additional rulemaking action would be needed. All comments submitted
will be available, both before and after the closing date for comments,
in the Rules Docket for examination by interested persons. Those
wishing the FAA to acknowledge receipt of their comments submitted in
response to this rule must submit a self-addressed, stamped postcard on
which the following statement is made: ``Comments to Docket No. FAA-
2008-0062; Airspace Docket No. 08-ANE-93.'' The postcard will be date
stamped and returned to the commenter.

The Rule

    This amendment to Title 14, Code of Federal Regulations (14 CFR)
part 71 establishes Class E airspace at Stonington, ME providing the
controlled airspace required to support the new Copter Area Navigation
RNAV Global Positioning System (GPS) 070 Point in Space (PinS) approach
developed for Stonington Municipal Airport. Controlled airspace
extending upward from 700 feet Above Ground Level (AGL) is required for
Instrument flight Rules (IFR) operations and to encompass all
Instrument Approach Procedures (iaps) to the extent practical,
therefore, the FAA is amending Title 14, Code of Federal Regulations
(14 CFR) part 71 to establish a 6-mile radius Class E5 airspace at
Stonington, ME Designations for Class E airspace areas extendding
upward from 700 feet or more above the surface of the Earth are
published in FAA Order 7400.9R, signed August 15, 2007 effective
September 15, 2007, which is incorporated by reference in 14 CFR part
71.1. The Class E designations listed in this document will be
published subsequently in the Order.

Agency Findings

    The regulations adopted herein will not have substantial direct
effects on the States, on the relationship between the national
government and the States, or on the distribution of power and
responsibilities among various levels of government. Therefore, it is
determined that this final rule does not have federalism implications
under Executive Order 13132.
    The FAA has determined that this regulation only involves an
established body of technical regulations for which frequent and
routine amendments are necessary to keep them operationally current, is
non-controversial and unlikely to result in adverse or negative
comments. It, therefore, (1) is not a ``significant regulatory action''
under

Executive Order 12866; (2) is not a ``significant rule'' under DOT
Regulatory Policies and Procedures (44 FR 11034; February 26, 1979; and
(3) does not warrant preparation of a Regulatory Evaluation as the
anticipated impact is so minimal. Since this is a routine matter that
will only affect air traffic procedures and air navigation, it is
cetified that this rule, when promulgated, will not have a significant
economic impact on a substantial number of small entities under the
criteria of the Regulatory Flexibility Act.
    The FAA's authority to issue rules regarding aviation safety is
found in Title 49 of the United States Code. Subtitle I, Section 106
describes the authority of the FAA Administrator. Subtitle VII,
Aviation Programs, describes in more detail the scope of the agency's
authority.
    This rulemaking is promulgated under the authority described in
Subtitle VII, Part A, Subpart I, Section 40103. Under that section, the
FAA is charged with prescribing regulations to assign the use of
airspace necessary to ensure the safety of aircraft and the efficient
use of airspace. This regulation is within the scope of that authority
as it establishes controlled airspace near Stonington Municipal Airport
in Stonington, ME.

Lists of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (Air).

Adoption of the Amendment

0
In consideration of the foregoing, the Federal Aviation Administration
amends 14 CFR part 71 as follows:

PART 71--DESIGNATION OF CLASS A, B, C, D AND E AIRSPACE AREAS; AIR
TRAFFIC SERVICE ROUTES; AND REPORTING POINTS

0
1. The authority citation for part 71 continues to read as follows:

    Authority: 49 U.S.C. 106(g); 40103, 40113, 40120; E.O. 10854, 25
FR 9565, 3 CFR, 1959-1963 Comp., p. 389.

Sec.  71.1   [Amended]

0
2. The incorporation by reference in 14 CFR 71.1 of Federal Aviation
Administration Order 7400.9R, Airspace Designations and Reporting
Points, signed August 15, 2007, effective September 15, 2007, is
amended as follows:

Paragraph 6005 Class E Airspace Areas Extending Upward from 700
feet or More Above the Surface of the Earth.

* * * * *

ANE ME E5 Stonington, ME [New]

Stonington Municipal Airport
    (Lat. 44[deg]10'24'' N., long. 68[deg]40'49'' W.)
Point in Space Coordinates
    (Lat. 44[deg]09'58'' N., long. 68[deg]41'37'' W.)

    That airspace extending upward from 700 feet above the surface
of the Earth within a 6-mile radius of the Point in Space
Coordinates (lat. 44[deg]09'58'' N., long. 68[deg]41'37'' W.)
serving Stonington Municipal Airport.
* * * * *

    Issued in College Park, Georgia, on January 31, 2008.
Barry A. Knight,
Acting Manager, System Support Group, Eastern Service Center.
[FR Doc. 08-731 Filed 2-20-08; 8:45 am]

BILLING CODE 4910-13-M


(i) The minimum distance between the observer and the emission
source shall be 5.0 meters (16 feet), and the sun shall be oriented in
the 140-degree sector of the back.
    (ii) The observer shall select a position that minimizes
interference from other fugitive coal dust emissions sources and make
observations such that the line of vision is approximately
perpendicular to the plume and wind direction.
    (iii) The observer shall make opacity observations at the point of
greatest opacity in that portion of the plume where condensed water
vapor is not present. Water vapor is not considered a visible emission.
    (3) A visible emissions observer may conduct visible emission
observations for up to three fugitive, stack, or vent emission points
within a 15-second interval if the following conditions specified in
paragraphs (a)(3)(i) through (iii) of this section are met.
    (i) No more than three emissions points may be read concurrently.
    (ii) All three emissions points must be within a 70 degree viewing
sector or angle in front of the observer such that

the proper sun position can be maintained for all three points.
    (iii) If an opacity reading for any one of the three emissions
points is within 5 percent opacity from the applicable standard
(excluding readings of zero opacity), then the observer must stop
taking readings for the other two points and continue reading just that
single point.
    (b) The owner or operator must conduct all performance tests
required by Sec.  60.8 to demonstrate compliance with the applicable
emissions standards specified in Sec.  60.252 according to the
requirements in Sec.  60.8 using the applicable test methods and
procedures in paragraphs (b)(1) through (8) of this section.
    (1) Method 1 or 1A of appendix A-4 of this part shall be used to
select sampling port locations and the number of traverse points in
each stack or duct. Sampling sites must be located at the outlet of the
control device (or at the outlet of the emissions source if no control
device is present) prior to any releases to the atmosphere.
    (2) Method 2, 2A, 2C, 2D, 2F, or 2G of appendix A-4 of this part
shall be used to determine the volumetric flow rate of the stack gas.
    (3) Method 3, 3A, or 3B of appendix A-4 of this part shall be used
to determine the dry molecular weight of the stack gas. The owner or
operator may use ANSI/ASME PTC 19.10-1981, ``Flue and Exhaust Gas
Analyses (incorporated by reference--see Sec.  60.17) as an alternative
to Method 3B of appendix A-2 of this part.
    (4) Method 4 of appendix A-4 of this part shall be used to
determine the moisture content of the stack gas.
    (5) Method 5, 5B or 5D of appendix A-4 of this part or Method 17 of
appendix A-7 of this part shall be used to determine the PM
concentration as follows:
    (i) The sampling time and sample volume for each run shall be at
least 60 minutes and 0.85 dscm (30 dscf). Sampling shall begin no less
than 30 minutes after startup and shall terminate before shutdown
procedures begin. A minimum of three valid test runs are needed to
comprise a PM performance test.
    (ii) Method 5 of appendix A of this part shall be used only to test
emissions from affected facilities without wet flue gas desulfurization
(FGD) systems.
    (iii) Method 5B of appendix A of this part is to be used only after
wet FGD systems.
    (iv) Method 5D of appendix A-4 of this part shall be used for
positive pressure fabric filters and other similar applications (e.g.,
stub stacks and roof vents).
    (v) Method 17 of appendix A-6 of this part may be used at
facilities with or without wet scrubber systems provided the stack gas
temperature does not exceed a temperature of 160 [deg] C (320 [deg] F).
The procedures of sections 8.1 and 11.1 of Method 5B of appendix A-3 of
this part may be used in Method 17 of appendix A-6 of this part only if
it is used after a wet FGD system. Do not use Method 17 of appendix A-6
of this part after wet FGD systems if the effluent is saturated or
laden with water droplets.
    (6) Method 6, 6A, or 6C of appendix A-4 of this part shall be used
to determine the SO2 concentration. A minimum of three valid
test runs are needed to comprise an SO2 performance test.
    (7) Method 7 or 7E of appendix A-4 of this part shall be used to
determine the NOX concentration. A minimum of three valid
test runs are needed to comprise an NOx performance test.
    (8) Method 10 of appendix A-4 of this part shall be used to
determine the CO concentration. A minimum of three valid test runs are
needed to comprise a CO performance test. CO performance tests are
conducted concurrently (or within a 60-minute period) with
NOX performance tests.

Sec.  60.258  Reporting and recordkeeping.

    (a) The owner or operator of a coal preparation and processing
plant that commenced construction, reconstruction, or modification
after April 28, 2008, shall maintain in a logbook (written or
electronic) on-site and make it available upon request. The logbook
shall record the following:
    (1) The manufacturer's recommended maintenance procedures and the
date and time of any maintenance and inspection activities and the
results of those activities. Any variance from manufacturer
recommendation, if any, shall be noted.
    (2) The date and time of periodic coal preparation and processing
plant visual observations, noting those sources with visible emissions
along with corrective actions taken to reduce visible emissions.
Results from the actions shall be noted.
    (3) The amount and type of coal processed each calendar month.
    (4) The amount of chemical stabilizer or water purchased for use in
the coal preparation and processing plant.
    (5) Monthly certification that the dust suppressant systems were
operational when any coal was processed and that manufacturer's
recommendations were followed for all control systems. Any variance
from the manufacturer's recommendations, if any, shall be noted.
    (6) Monthly certification that the fugitive coal dust emissions
control plan was implemented as described. Any variance from the plan,
if any, shall be noted. A copy of the applicable fugitive coal dust
emissions control plan and any letters from the Administrator providing
approval of any alternative control measures shall be maintained with
the logbook. Any actions, e.g. objections, to the plan and any actions
relative to the alternative control measures, e.g. approvals, shall be
noted in the logbook as well.
    (7) For each bag leak detection system, the owner or operator must
keep the records specified in paragraphs (a)(7)(i) through (iii) of
this section.
    (i) Records of the bag leak detection system output;
    (ii) Records of bag leak detection system adjustments, including
the date and time of the adjustment, the initial bag leak detection
system settings, and the final bag leak detection settings; and
    (iii) The date and time of all bag leak detection system alarms,
the time that procedures to determine the cause of the alarm were
initiated, the cause of the alarm, an explanation of the actions taken,
the date and time the cause of the alarm was alleviated, and whether
the cause of the alarm was alleviated within 3 hours of the alarm.
    (8) A copy of any applicable monitoring plan for a digital opacity
compliance system and monthly certification that the plan was
implemented as described. Any variance from plan, if any, shall be
noted.
    (9) During a performance test of a wet scrubber, and each operating
day thereafter, the owner or operator shall record the measurements of
the scrubber pressure loss, water supply flow rate, and pH of the wet
scrubber liquid.
    (10) During a performance test of control equipment other than a
wet scrubber, and each operating day thereafter, the owner or operator
shall record the measurements of the reagent injection flow rate, as
applicable.
    (b) For the purpose of reports required under section 60.7(c), any
owner operator subject to the provisions of this subpart also shall
report semiannually periods of excess emissions as follow:
    (1) The owner or operator of an affected facility with a wet
scrubber shall submit semiannual reports to the Administrator or
delegated authority of occurrences when the measurements of the
scrubber pressure loss, water supply flow rate, or pH of the wet
scrubber liquid vary by more than 10 percent

from the average determined during the most recent performance test.
    (2) The owner or operator of an affected facility with control
equipment other than a wet scrubber shall submit semiannual reports to
the Administrator or delegated authority of occurrences when the
measurements of the reagent injection flow rate, as applicable, vary by
more than 10 percent from the average determined during the most recent
performance test.
    (3) All 6-minute average opacities that exceed the applicable
standard.
    (c) The owner or operator of an affected facility shall submit the
results of initial performance tests to the Administrator or delegated
authority, consistent with the provisions of section 60.8. The owner or
operator who elects to comply with the reduced performance testing
provisions of sections 60.255(c) or (d) shall include in the
performance test report identification of each affected facility that
will be subject to the reduced testing. The owner or operator electing
to comply with section 60.255(d) shall also include information which
demonstrates that the control devices are identical.
    (d) After July 1, 2011, within 60 days after the date of completing
each performance evaluation conducted to demonstrate compliance with
this subpart, the owner or operator of the affected facility must
submit the test data to EPA by successfully entering the data
electronically into EPA's WebFIRE data base available at http://
cfpub.epa.gov/oarweb/index.cfm?action=fire.main. For performance tests
that cannot be entered into WebFIRE (i.e., Method 9 of appendix A-4 of
this part opacity performance tests) the owner or operator of the
affected facility must mail a summary copy to United States
Environmental Protection Agency; Energy Strategies Group; 109 TW
Alexander DR; mail code: D243-01; RTP, NC 27711.

[FR Doc. E9-23783 Filed 10-7-09; 8:45 am]

BILLING CODE 6560-50-P


[Federal Register Volume 84, Number 64 (Wednesday, April 3, 2019)]
[Notices]
[Pages 13050-13057]
[FR Doc No: 2019-06468]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

[Docket Number USCG-2018-0193]

Polar Icebreaker Program; Record of Decision for the Polar
Security Cutter Environmental Impact Statement

AGENCY: Coast Guard, DHS.

ACTION: Record of decision.

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SUMMARY: The U.S. Coast Guard, as lead agency, announces the
availability of the Record of Decision for the approved Polar Security
Cutter Programmatic Environmental Impact Statement (EIS) in accordance
with the National Environmental Policy Act (NEPA) for the Polar
Security Cutter Program's design and build of up to six polar
icebreakers. This publication serves as the Record of Decision on the
final EIS and includes a full summary of the environmental analysis and
consequences.

DATES: The decision became operative on March 18, 2019.

ADDRESSES: The complete text of the final EIS and any supporting
documents related to this decision are available in the docket which
can be found by searching the docket number USCG-2018-0193 at https://www.regulations.gov.

FOR FURTHER INFORMATION CONTACT: If you have questions about this
Record of Decision (ROD), email Ms. Christine Wiegand, Assistant
Program Manager for Acquisition, Polar Security Cutter Program, U.S.
Coast Guard; email [email protected].

SUPPLEMENTARY INFORMATION:

Table of Contents

I. Table of Abbreviations
II. Record of Decision
III. Background and Issues
IV. Purpose and Need
V. Public Involevement
VI. Alternatives Considered
VII. Summary of Environmental Analysis and Consequences (Preferred
Alternative)
    A. Acoustic Stressors
    B. Summary of Impacts From Acoustic Stressors
    C. Physical Stressors
    D. Summary of Impacts From Physical Stressors
    E. Socioeconomic Impacts
    F. Summary of Impacts to Resource Areas
    G. Mitigation Measures
    H. Monitoring, Research, and Reporting
VIII. Agency Consultation and Coordination
VIII. Conclusion

I. Table of Abbreviations

CFR Code of Federal Regulations
CGC Coast Guard Cutter

EIS Environmental Impact Statement
FR Federal Register
NEPA National Environmental Policy Act
PIBs Polar Icebreakers
PSC Polar Security Cutter
ROD Record of Decision
U.S.C. United States Code

II. Record of Decision

    Pursuant to Section 102(2)(c) of the National Environmental Policy
Act (NEPA) of 1969, Sections 4321 et seq. of Title 42 U.S.C., Council
on Environmental Quality Regulations (1500-1508 of Title 40 Code of
Federal Regulations [CFR], and Executive Order 12114, Environmental
Effects Abroad of Major Federal Actions), the Coast Guard announces its
decision to implement the Coast Guard's preferred Alternative,
Alternative 1, including the full range of mitigation measures, as
described in the PSC's Final Programmatic EIS. This decision will
enable the Coast Guard to carry out the Coast Guard's primary missions
supported by PSC. A detailed description of Alternative 1 is provided
in Chapter 2 (Description of the Proposed Action and Alternatives) of
the PSC Final Programmatic EIS.

III. Background and Issues

    The Coast Guard is a military, multi-mission, maritime service
within the Department of Homeland Security and one of the nation's five
armed services. In executing its various missions, the Coast Guard
protects the public, the environment, and U.S. economic and security
interests in maritime regions, including international waters and the
coasts, ports, and inland waterways of the U.S., as required to support
national security.
    As the polar regions of the Arctic and Antarctic become more
accessible, they become more important to U.S. and international
interests. Polar icebreakers enable the Coast Guard to enforce treaties
and other laws needed to safeguard both industry and the environment;
provide ports, waterways and coastal security; provide logistical
support; and support all other Coast Guard missions. Any increase in
vessel traffic in the polar regions increases the potential for more
search and rescue missions, water pollution, illegal fishing, and
infringement on the U.S. Exclusive Economic Zone, which requires Coast
Guard presence. In response to this potential surge in vessel traffic,
a long term increase in Coast Guard mission demand is projected, thus
requiring additional capacity from PSCs. The Proposed Action would
allow the Coast Guard to meet the increasing demand in the polar
regions, as well as year-round mission requirements.

IV. Purpose and Need

    The Coast Guard's current fleet of polar icebreakers consists of
two heavy icebreakers, Coast Guard Cutter (CGC) POLAR STAR and CGC
POLAR SEA, and one medium icebreaker, CGC HEALY. The Coast Guard's
heavy icebreakers have both exceeded their designed 30-year service
life. CGC POLAR STAR was commissioned in 1976 and CGC POLAR SEA in
1978. CGC POLAR STAR completed a service life extension in 2013 to
allow CGC POLAR STAR to operate for an additional seven to ten years.
CGC POLAR SEA has remained out of service since 2010 and is not
expected to be reactivated. The PSC program acquisition strategy to
construct up to three PSCs and may (at a future date) expand to include
up to three additional icebreakers, with design service lives of 30
years each. The first of these new PSCs is expected to be delivered in
2023. Because the first new PSC would not be operational in the Polar
Regions until at least 2023, new information may become available after
the completion of the Programmatic EIS. In that case, supplemental NEPA
documentation may, as appropriate, be prepared in support of individual
proposed actions and tiered to the PSC Final Programmatic EIS. Examples
of new information may include, but are not limited to, changes to a
species listing status or any other applicable laws and directives, and
information regarding mission, training, homeporting, maintenance, and
eventual decommissioning of the new PSCs.
    PSCs will be designed to carry out the Coast Guard's primary
missions supported by the current polar icebreaker fleet. Expected
missions include Ice Operations; Defense Readiness; Aids to Navigation;
Living Marine Resources; Marine Safety; Marine Environmental
Protection; Other Law Enforcement; Ports, Waterways, and Coastal
Security; and Search and Rescue. In executing its various missions, the
Coast Guard protects the public, the environment, and U.S. economic and
security interests in maritime regions, including international waters
and the Nation's coasts, ports, and inland waterways, as required to
support national security. Legislation and executive orders assign the
Coast Guard a wide range of responsibilities applicable to Polar
Regions. The Coast Guard derives its authority for the use of
icebreaking from several statutes governing execution of its missions.
These include 14 U.S.C. 81 (Coast Guard establishment, maintenance, and
operation of aids to navigation), 14 U.S.C. 88 (Coast Guard saving of
life and property), 14 U.S.C. 89 (Coast Guard law enforcement), 14
U.S.C. 90 (Arctic maritime transportation), 14 U.S.C. 91 (controlling
anchorage and movement of vessels), 14 U.S.C. 94 (conduct oceanographic
research), and 14 U.S.C. 141 (cooperation with agencies, States,
territories, and others). In addition, Executive Order 7521 (Use of
Vessels for Icebreaking in Channels and Harbors; 1 FR 2184; December
24, 1936), directs the Coast Guard to assist in keeping channels and
harbors open to navigation by means of icebreaking operations.
    The Coast Guard proposes to conduct PSC operations and training
exercises to meet Coast Guard mission responsibilities in the U.S.,
Arctic and Antarctic Regions of operation, in addition to vessel
performance testing post-dry dock in the Pacific Northwest near the
current polar icebreaker homeport of Seattle, Washington. While the
exact location for future homeporting has not been determined, the
current fleet of polar icebreakers is homeported in Seattle,
Washington.
    Polar Regions are becoming increasingly important to U.S. national
interests. The changing environment in these regions could lead to a
rise in human activity and increased commercial ship, cruise ship, and
naval surface ship operations, as well as increased exploration for oil
and other resources, particularly in the Arctic. One of the Coast
Guard's highest priorities is safety of life at sea. This entails the
Arctic responsibilities described above as well as assisting with
Antarctica logistics at McMurdo Station. Long-term projected increases
in Coast Guard mission demand in the Polar Regions would require
additional support from PSCs. A lack of infrastructure, polar
environmental conditions, and long distances between operating areas
and support bases all influence the Coast Guard's ability to provide
comparable service and presence in Polar Regions as compared to that
provided in other non-polar areas of operation with existing Coast
Guard assets.
    The PSC Final Programmatic EIS analyzed the potential impacts of up
to six new PSCs, as this is the maximum number anticipated to be
operational in the Polar Regions under the current PSC program
acquisition strategy. A lesser number of icebreakers is expected to
result in a similar or reduced impact than what was discussed and
evaluated in the EIS. Potential environmental stressors include
acoustic (underwater acoustic transmissions, vessel noise, icebreaking
noise, aircraft noise, and

gunnery noise), and physical (vessel movement, aircraft or in-air
device movement, in-water device movement, icebreaking, and marine
expended materials).

V. Public Involvement

    The public scoping period began with issuance of the Notice of
Intent in the Federal Register (83 FR 18319) on April 26, 2018. The
scoping period lasted 60 days, concluding on June 25, 2018. The public
was provided a variety of methods to comment on the scope of the PSC
Final Programmatic EIS during the scoping period. Communication methods
used by the Coast Guard to distribute the proposed project information
to residents of Alaska included: Radio, newspapers, fliers, electronic
mail (email), and websites. Public presentations of the Proposed Action
and preliminary findings were provided at public meetings held in
Alaska. These meetings were advertised with fliers and newspaper
postings, as well as in radio announcements and on social media.
    A project website was established to facilitate public input within
and outside the Arctic, Antarctic, and Pacific Northwest regions
(http://www.dcms.uscg.mil/Our-Organization/Assistant-Commandant-for-Acquisitions-CG-9/Programs/Surface-Programs/Polar-Icebreaker/). The
scheduling of public meetings was publicized in press releases
available on the Coast Guard's website, in the Federal Register Notice
(83 FR 18319; April 26, 2018), as well as in local newspapers--the
Anchorage Daily News, the Arctic Sounder, and the Nome Nugget and
social media sites, such as Facebook. Targeted emails were sent to the
Tribal communities in the regions of Nome (Bering Straits Region),
Kotzebue (Nana Region), Anchorage, and Barrow/Utqiagvik (Arctic Slope
Region) to notify them that the public meetings were taking place.
Public meetings were held in Nome (May 7, 2018), Kotzebue (May 9,
2018), Anchorage (May 11, 2018), and in Barrow/Utqiagvik (May 14,
2018). The public meeting in Nome had 10 attendees, the meeting in
Kotzebue had 4 attendees, and the meeting in Barrow/Utqiagvik had 5
attendees. The meeting in Anchorage was not attended by any members of
the public. A Notice of Availability and request for comments was
publicized in the Federal Register Notice (83 FR 38317; August 6, 2018)
to notify the public of the 45-day public review period for the PSC
Draft Programmatic EIS. Comments from the public are addressed in
Appendix C of the PSC Final Programmatic EIS.
    A notice of availability of final programmatic EIS was posted in
the docket on February 15, 2019 along with the full text of the final
EIS. The program waited 30 days to make a final decision on the
proposal. The Coast Guard received one comment which did not require
revisions to the Final PSC Programmatic EIS.

VI. Alternatives Considered

    Two alternatives in addition to the Proposed Action (Alternative 1,
Preferred Alternative) were evaluated in the PSC Final Programmatic
EIS. The following provides a brief description of each alternative
considered:
    Alternative 1. Proposed Action (Preferred Alternative). The design,
build, and operation of up to six PSCs.
    Alternative 2. Leasing. Considered various forms of vessel leasing,
such as those leases used by the U.S. Navy, the National Science
Foundation, other federal agencies, and the domestic maritime industry.
    Alternative 3. No Action. No new icebreakers would be built or
leased, and the Coast Guard would fulfill its missions in the Arctic
and Antarctic using existing polar icebreaker assets.

VII. Summary of Environmental Analysis and Consequences (Preferred
Alternative)

A. Acoustic Stressors

    The acoustic stressors from the Proposed Action include underwater
acoustic transmissions (e.g., navigational technologies), vessel noise,
icebreaking noise, aircraft noise, and gunnery noise. Potential
acoustic impacts may include auditory masking (a sound interferes with
the audibility of another sound that marine organisms may rely on),
permanent threshold shift, temporary threshold shift, or a behavioral
response. In general, the Coast Guard would use a PSC that would
operate navigational technologies, including radar and sonar, while
underway. Marine species within the Arctic and Antarctic proposed
action areas may also be exposed to icebreaking noise associated with a
PSC's activities. In assessing the potential impact to species from
acoustic sources, a variety of factors were considered, including
source characteristics, animal presence, animal hearing range, duration
of exposure, and impact thresholds for those species that may be
present. The Coast Guard evaluated the data and conducted an analysis
of the species distribution and likely responses to the acoustic
stressors based on available scientific literature. Icebreaking noise
is generally described as a low frequency, 10 to 100 Hertz (Hz) (Roth
et al. 2013), non-impulsive sound. Similarly, vessel noise is also
characterized as low frequency. As such, a species response to
icebreaking noise would be expected to be similar to their response to
vessel noise. The Coast Guard used specific methods, described below,
to quantify potential effects to marine mammals from icebreaking. Non-
marine mammal biological resources, such as seabirds, fish, and
invertebrates that may potentially overlap with the proposed
icebreaking area, were analyzed using qualitative methods, also
described below, because the modeling exposure criteria were developed
only for marine mammals and sea turtles. Sea turtles were not assessed
for icebreaking sound exposure as their geographic ranges do not
overlap any a proposed icebreaking areas.
    Marine mammals are difficult to observe in real time and have
varied behaviors based on species, geographic location, and time of
year. Furthermore, field-based information on the effects of
icebreaking on marine mammals is unavailable. Therefore, mathematical
modeling was necessary to estimate the number of marine mammals that
may be affected by icebreaking activities. The U.S. Department of the
Navy (Navy) has invested considerable effort and resources analyzing
the potential impacts of underwater sound sources (i.e., impulsive and
non-impulsive sources) on marine mammals and sea turtles. The Navy has
used the Navy Acoustic Effects Model (NAEMO) to model acoustic impacts
to marine mammals. NAEMO has been refined since its inception and
documented in many environmental assessments and impact statements
developed for Navy exercises. NAEMO was developed based on published
research, in collaboration with subject matter experts, and the Center
for Independent Experts--an external peer-review system under the
purview of National Marine Fisheries Service (NMFS). The Coast Guard
used the Navy's NAEMO model to quantify the potential impacts on marine
mammals from icebreaking associated with the Proposed Action. Based on
modeling results, the following marine mammals exposed to icebreaking
would be expected to elicit a behavioral reaction: Antarctic minke
whale (Balaenoptera bonaerensis), Arnoux's beaked whale (Berardius
arnuxii), bearded seal (Erignathus barbatus), blue whale (Balaenoptera
musculus), bowhead whale (Balaena mysticetus), crabeater seal (Lobodon
carcinophaga), Gray's beaked whale (Mesoplodon

grayi), humpback whale (Megaptera novaeangliae), killer whale (Orcinus
orca), leopard seal (Hydrurga leptonyx), minke whale (Balaenoptera
acutorostrata), polar bear (Ursus maritimus), ringed seal (Phoca
hispida), Ross seal (Ommatophoca rossi), southern bottlenose whale
(Hyperoodon planifrons), and Weddell seal (Leptonychotes weddellii).
    In general, if marine mammal, invertebrate, fish, bird, or sea
turtle hearing ranges did not overlap with the frequency of the
acoustic sources, such as for acoustic transmissions, further analysis
was not conducted in the Programmatic EIS. If hearing ranges did
overlap, the analysis in the PSC Programmatic Final EIS considered the
temporary nature of the Proposed Action and the current ambient noise
levels in the proposed action areas, which all limited the exposure and
impact from acoustic stressors to those species. Qualitative analyses
of vessel noise and icebreaking noise were conducted similarly for all
species groups, with the exception of marine mammals (where the NAEMO
model was used to analyze potential impacts from icebreaking noise), as
both sounds are typically characterized as low frequency (less than 1
kilohertz and between 10 to 100 Hz, respectively) (Roth et al. 2013)
acoustic sources. Qualitative analyses of potential impacts from
exposure to aircraft noise considered in-air hearing ranges for exposed
species (when known or a surrogate species was evaluated) and the
dominant tones in noise spectra from helicopters and fixed wing
aircraft, as below 500 Hz (Richardson et al. 1995); qualitative
analyses evaluated both in-air and underwater exposure from the air-to-
surface interface. Since the typical operating altitude for helicopters
and unmanned aerial vehicles (UAVs) associated with the Proposed Action
would be at or above 1,000 feet (305 meters), it was assumed that the
received levels from aircraft would significantly decrease from the
sound levels expected at the source.

B. Summary of Impacts From Acoustic Stressors

    Based on the analysis, impacts from acoustic sources associated
with the Proposed Action are expected to result in, at most, minor to
moderate behavioral responses over short and intermittent periods.
Underwater acoustic transmissions, vessel noise, icebreaking noise,
aircraft noise, and gunnery noise would not result in significant
impact to invertebrates, fish, essential fish habitat (EFH), birds, sea
turtles, and marine mammals. Those species listed as endangered or
threatened under section 7 of the Endangered Species Act (ESA), would
not be expected to respond in ways that would significantly disrupt
normal behavior patterns which include, but are not limited to:
Migration, breathing, nursing, breeding, feeding, or sheltering.
Acoustic stressors from the Proposed Action would not cause population
level effects to any ESA-listed species in the proposed action areas.
Additionally, when possible, the Coast Guard would avoid all known
critical habitat areas. For those species where authorizations or
permits may be required, the Coast Guard intends to consult with the
appropriate regulatory agency to ensure environmental compliance. The
timing of this permit request would coincide more closely with the time
the first PSC is operational, due to expected updates to information
and potential changes to a species listing status.

C. Physical Stressors

    Vessels and aircraft associated with the Proposed Action would be
widely dispersed throughout the proposed action areas. The physical
stressors from the Proposed Action include vessel movement, aircraft
movement, autonomous underwater vehicle (AUV) movement, icebreaking,
and military expended materials (MEM). The physical presence of
aircraft and vessels could lead to behavioral reactions from visual or
auditory cues. In assessing the potential impact to species from
physical sources, a variety of factors were considered, including
vessel and operation characteristics, animal presence, and likelihood
of exposure. The Coast Guard evaluated the data and conducted an
analysis of the species distribution and likely responses to the
physical stressors based on available scientific literature. Reactions
to vessels often include changes in general activity (e.g., from
resting or feeding to active avoidance), changes in surface respiration
or dive cycles (marine mammals), and changes in speed and direction of
movement. The severity and type of response exhibited by an individual
may also be influenced by previous encounters with vessels. Some
species have been noted to tolerate slow-moving vessels within several
hundred meters, especially when the vessel is not directed toward the
animal and when there are no sudden changes in direction or engine
speed (Richardson et al. 1995). In addition, vessels and aircraft could
collide with resources found in all proposed action areas.
    The PSC Final Programmatic EIS considered vessel tow training, when
evaluating the potential impacts of vessel movement on resources in the
proposed action areas. In general, short-term and localized
disturbances are anticipated. The likelihood that an individual would
interact with the vessel tow cable and become entangled is low because
the tow lines would have no loops or slack, thereby reducing the
likelihood of entanglement. Although the tow cable and towed vessel may
impact fish, birds, and marine mammals encountered along a tow route,
the chance that such an encounter would result in serious injury is
extremely remote because of the low probability that an individual of a
species would overlap with the infrequent tow training events.
    Potential collision of vessels with biological resources was also
considered in the analysis of vessel movement. The likelihood that a
vessel would strike an invertebrate or a fish is extremely low because
many of these animals would not be expected in the path of the vessel
due to benthic distribution and any surface-dwelling species would be
expected to avoid the vessel. The probability of a seabird colliding
with a vessel would increase at night and in situations of poor
visibility; however, the likelihood of a vessel collision with a bird
is extremely low because a PSC would likely operate farther offshore
than where the majority of birds would be expected; a PSC would only
operate navigational safety lights at night that would not be expected
to attract birds; and during times of reduced visibility, a vessel
would likely reduce vessel speeds for navigational safety. Flightless
birds, including penguins and molting birds, would also be susceptible
to a vessel collision; however, the Coast Guard's Standard Operating
Procedures (SOP) and Best Management Practices (BMP) would minimize
potential impacts. Sea turtles are also known to be attracted to
lights, but similar to birds, the navigational safety lights would not
be expected to act as an attractant to sea turtles.
    Marine mammal species most vulnerable to collision are thought to
be those that spend extended periods at the surface or species whose
unresponsiveness to vessel sound makes them more susceptible to vessel
collisions. Although the maximum speed of the PSC during vessel
propulsion testing is 12-17 knots, a PSC is expected to operate at
slower speeds during most of the Proposed Action activities. While
slower speeds could decrease the chance of a fatal collision, it will
not eliminate the risk of a collision. In addition, any vessel
collision has the chance of causing

serious injury or mortality. However, the Coast Guard's SOPs and BMPs,
in addition to the slow vessel speeds, would decrease the risk of a
collision with a marine mammal. AUV movement could impact biological
resources, including invertebrates, fish, seabirds, and marine mammals;
however, the potential for an AUV to strike individuals is similar to
that identified for vessels in the analysis. Any animal that was
displaced would be expected to resume normal activities due to the
short-term and localized nature of the disturbance. Collision risk with
an AUV is considered to be extremely low.
    With the exception of birds, no other biological resources are
expected to interact with aircraft, so other biological resources were
not assessed. The aircraft used during the Proposed Action would be the
MH-60 Jayhawk helicopter and UAVs for ice reconnaissance. Birds would
be most at risk of a strike during takeoff and landing because the
helicopter is passing through the lower altitudes where birds may be
found. Bird strikes are a serious concern for helicopter crews not only
because of the risk to the birds, but also because they can harm
aircrews and equipment. For this reason, the Coast Guard would avoid
large flocks of birds to increase personnel safety and minimize any
risk associated with a bird-aircraft strike and would follow SOPs and
BMPs to avoid critical habitat areas and areas where there are known
gatherings of seabirds. While there is some risk of an aircraft-seabird
strike associated with the Proposed Action, the risk of a strike is
low. Should a collision occur, bird mortality or injuries due to the
strike caused by helicopter or UAV movement may result, but population
level impacts to seabirds are not expected.
    Icebreaking would occur in the Arctic and Antarctic proposed action
areas at speeds of 3 to 6 knots. It has the potential to impact marine
species by altering habitats, causing behavior reactions, or colliding
with resources. There would be no impact to sea turtles as they are not
found in the icebreaking areas. Marine vegetation living under ice may
encounter short-term and localized disturbances from icebreaking;
however, no long-term or population level effects are expected as the
amount of biomass that would potentially be impacted is insignificant
relative to the overall biomass of the system. Due to the low speed of
the PSC during icebreaking operations, it is expected that fish
species, along with seabirds and marine mammals, would exhibit
temporary behavioral responses to the presence of icebreaking.
Icebreaking is not expected to significantly alter Arctic cod ice floe
habitat, the only EFH that has the potential to overlap with potential
icebreaking areas. In the Antarctic proposed action area, Ad[eacute]lie
penguins breed on land, and emperor penguins breed in the austral
autumn; however, neither species would be exposed to icebreaking
operations in the austral summer, when most icebreaking in the
Antarctic is expected to occur. For marine mammal species, because the
noise associated with icebreaking activities is most likely to result
in marine mammals avoiding the PSC or area for a short period, it is
highly unlikely that a PSC would strike a marine mammal or cause any
physical harm. However, pinnipeds and polar bears that haul out on the
ice may be more susceptible to icebreaking impacts. Icebreaking may
result in localized changes to the polar bear and proposed ringed seal
critical habitat as larger sheets of floating ice are broken down into
smaller sizes. However, icebreakers do not diminish or destroy ice
habitat because the amount of ice that is broken up relative to the
overall total amount of available ice is small. Since the impact would
be limited only to the area directly in the path of the PSC, short-term
and localized disturbances would be expected and any animal that was
displaced would be expected to resume normal activities after any brief
disturbance.
    MEM were assessed, including ingestion of MEM by marine species,
when evaluating the potential impacts of gunnery training activities on
resources in the proposed action areas. MEM from gunnery training
activities would include targets, target fragments, and inert small
caliber projectiles that would not be recovered. Most likely, the
targets used would drift with currents until popping, then sink through
the water column and end up on the seafloor. Impacts on soft bottom
habitats from small caliber projectiles would be short term, as these
are constantly moving and shifting. It is anticipated that, over time,
projectiles could become colonized by invertebrates, thus becoming part
of the bottom habitat. Due to the short-term impact of MEM on the
seafloor, MEM is not anticipated to adversely affect the quality or
quantity of EFH. Although unlikely, small pieces of MEM may be ingested
by an organism; however, targets and target fragments left as expended
material are not in high enough densities to cause population level
impacts.

D. Summary of Impacts From Physical Stressors

    Based on the analysis, impacts from physical stressors associated
with the Proposed Action are expected to result in, at most, minor to
moderate behavioral responses over short and intermittent periods.
Devices associated with the Proposed Action with a potential for
entanglement include the lines used in vessel tow. For an organism to
become entangled in a line or material, the materials must have certain
properties, such as the ability to form loops and a high breaking
strength. Towing lines would not be expected to have any loops or
slack. The likelihood that a biological resource would become entangled
in tow lines is extremely low. Vessel movement, aircraft movement, AUV
movement, icebreaking, and MEM would not result in significant impact
to bottom habitat and sediment, marine vegetation, invertebrates, fish,
EFH, birds, sea turtles, and marine mammals.
    Those species listed as endangered or threatened under section 7 of
the ESA would not be expected to respond in ways that would
significantly disrupt normal behavior patterns which include, but are
not limited to: Migration, breathing, nursing, breeding, feeding, or
sheltering. Physical stressors from the Proposed Action would not cause
population level effects to any ESA-listed species in the proposed
action areas. When possible, the Coast Guard would avoid all known
critical habitat areas.
    The Proposed Action includes the breaking of ice and ice is a
physical and biological feature essential to the conservation of ESA-
listed species. However, during icebreaking, the Proposed Action would
not alter the specific physical or biological features of that ice
which is essential to the conservation of ESA-listed species, including
ringed seal and polar bear sea ice habitat. For those species where
authorizations or permits may be required, the Coast Guard intends to
consult with the appropriate regulatory agency to ensure environmental
compliance. The timing of this permit request would coincide more
closely with the time the first PSC is operational, due to expected
updates to information and potential changes to a species listing
status.

E. Socioeconomic Impacts

    Commercial fishing, recreational fishing, research, transportation
and shipping, tourism, and subsistence hunting and cultural resources
are the socioeconomic resources that would be impacted by the Proposed
Action. The predominant socioeconomic impact of a PSC would be an
increased Coast Guard presence in the proposed action areas and the
Coast Guard's jurisdictional areas. Replacement of the Coast Guard's

aging polar icebreaker fleet would facilitate the Coast Guard's ability
to support the Coast Guard missions including law enforcement,
consistent search and rescue capabilities, and on-going research
operation support.

F. Summary of Impacts to Resource Areas

    An increase in the Coast Guard icebreaking fleet would be
beneficial, and any potential negative impacts caused by the Coast
Guard's presence and operations and training would be mitigated by the
implementation of SOPs and BMPs. Additionally, outreach and educational
programs conducted by the Coast Guard within the proposed action areas
would facilitate communication between Coast Guard and the communities
that they serve. More readily available Coast Guard support during an
at-sea emergency is the principal benefit from the Proposed Action to
commercial fishing, recreational fishing, transportation and shipping,
tourism, and cultural resources and the communities that depend on
them.
    Vegetation. MEM may sink to the bottom during gunnery training, but
any impacts to marine vegetation, if present, would be temporary. A PSC
would also not set the anchor in areas where marine vegetation is
likely to occur in the proposed action areas. No significant impacts or
significant harm to marine vegetation is expected in all proposed
action areas.
    Invertebrates. Vessel and icebreaking noise, if perceived by an
invertebrate, would likely result in avoidance behavior or other short
term temporary responses, but would not result in any population level
impact. Vessel and AUV movement has the potential to impact marine
invertebrates either by disturbing the water column or directly
striking the organism, if it is present on or near the ice. Although
unlikely, invertebrates could be killed or displaced during
icebreaking. Because the impact would be localized to the immediate
path of a PSC, icebreaking disturbance would not be expected to have
population level impacts. Vessel noise, icebreaking noise, vessel
movement, AUV movement, and icebreaking would not result in significant
impact or result in significant harm to invertebrates in all proposed
action areas.
    Habitats. Acoustic transmissions could increase in ambient sound
level; however, this potential reduction in the quality of the acoustic
habitat would be localized and temporary. Icebreaking associated with
the Proposed Action may affect the quality or quantity of Arctic cod
EFH; however, the effects of icebreaking on Arctic cod EFH would be
minimal, due to the small area of icebreaking as compared to the
overall quantity of ice floe habitat. MEM impacts on soft bottom
habitats would be short term, as sediments are constantly moving and
shifting. Underwater acoustic transmissions, icebreaking, and MEM would
not result in significant impact or significant harm to EFH in the
Arctic and Pacific Northwest proposed action areas. No EFH is
designated in the Antarctic proposed action area.
    Fish. Underwater acoustic transmissions, vessel noise, icebreaking
noise, and icebreaking would likely result in short-term and
insignificant behavioral reactions or avoidance behavior, and thus,
would not be expected to have any population level impacts. AUV and
vessel movement may result in short-term and local displacement of fish
in the water column. Although unlikely, small pieces of MEM from
gunnery training and small caliber practice munitions may be ingested
by an individual. Vessel noise, icebreaking noise, vessel movement, AUV
movement, icebreaking, and MEM, would not result in significant impacts
or significant harm to fish in all proposed action areas.
    Marine Mammals. Acoustic transmissions and icebreaking noise may
result in minor to moderate behavioral responses to exposed
individuals, but the behavioral response is expected to be temporary.
Vessel noise may elicit a minor behavioral response by exposed
individuals. Any noise generated by the UAV is expected to be minimal
and below the hearing threshold of marine mammals, both in air and
underwater. The noise from the UAV is not expected to penetrate below
the water's surface; however, in the unlikely event that a marine
mammal is exposed to UAV noise underwater, any behavioral response is
expected to be very minor. The probability of a vessel encountering a
marine mammal is expected to be low, decreasing the risk of a PSC-
marine mammal collision. The risk of a collision between an AUV moving
through the water and a marine mammal is extremely low. It is expected
that icebreaking noise would alert marine mammals to the presence of a
PSC before icebreaking would overlap with a marine mammal. Therefore,
due to the expected avoidance behaviors caused by icebreaking noise,
the likelihood that a PSC would collide with a marine mammal during
icebreaking is extremely low. Pinnipeds or polar bears that may be
observed on the surface of the ice may be more susceptible to impacts
caused by icebreaking, but avoidance responses are also expected and
SOPs and BMPs, such as trained Coast Guard lookouts, would minimize any
potential impacts. During the Arctic summer months, from May to
September, pupping would not occur and subnivean lairs would not be
occupied. Icebreaking would only occur when needed, and based on
historical icebreaking, the majority occurs during the summer months.
Therefore, the likelihood that a PSC would impact a subnivean lair is
low. MEM has the potential to impact marine mammal species that feed on
the bottom, if ingested, but the likelihood that a marine mammal would
ingest MEM is extremely low. The Proposed Action is not expected to
cause abandonment of breeding or avoidance of breeding areas,
disruption of migration or feeding, or significant disruption to
pinniped haul outs. Underwater acoustic transmissions, vessel noise,
icebreaking noise, aircraft noise, vessel movement, AUV movement,
icebreaking, and MEM would not result in significant impact or
significant harm to marine mammals.
    Sea Turtles. Vessel noise in the open ocean may cause a startle
response in sea turtles; however, any response is expected to be short
term and temporary. Vessel noise from a PSC would not be expected to
impact a sea turtle's ability to perceive other biologically relevant
sounds. Although sea turtles would likely hear and see approaching
vessels, a risk of a vessel collision with a sea turtle exists;
however, sea turtles spend most of their time submerged, which would
reduce their risk of a vessel collision. Vessel noise and vessel
movement would not result in significant impact or result in
significant harm to sea turtles in the Pacific Northwest proposed
action area or in the Arctic proposed action area (although the
leatherback sea turtle is considered extralimital). Aircraft movement,
aircraft noise, icebreaking, and icebreaking noise would have no
significant impact or significant harm on sea turtles as sea turtles
would not overlap in areas where aircraft operations and icebreaking
are expected.
    Birds. Vessel noise, icebreaking noise, vessel movement, and
icebreaking would likely result in temporary behavioral responses. Any
increase in ambient noise as a result of icebreaking or vessel movement
would be temporary and localized to the position of the vessel as it
transits or when icebreaking. Aircraft noise and gunnery noise may
elicit, at most, short-term behavioral or physiological responses to
exposed

birds, such as an alert or startle response, or temporary increase in
heart rate. While there is some risk of an aircraft-seabird strike, due
to Coast Guard mitigation measures (e.g., limited duration of aerial
operations) and avoidance of aircraft by seabirds, the risk of a strike
is low. The potential for a bird strike by the AUV is extremely low,
given the limited amount of time seabirds spend in the water relative
to the air and low likelihood a diving seabird would overlap with AUV
routes. Because of the small number of gunnery training targets, and
the distance at which targets would be dispersed in the Arctic and
Pacific Northwest proposed action areas, target and target fragments
would not present a significant threat to seabird populations. Vessel
noise, icebreaking noise, aircraft noise, gunnery noise, vessel
movement, aircraft movement, AUV movement, icebreaking, and MEM would
not result in significant impact or significant harm to seabirds.

G. Mitigation Measures

    The Proposed Action includes SOPs and BMPs developed during federal
and state agency permitting and approval processes, or as standard
provisions for Coast Guard work. These SOPs and BMPs would be employed
to avoid or minimize potential effects on the environment. Although
SOPs and BMPs are established on a vessel-by-vessel basis, SOPs and
BMPs currently in use by other icebreaking vessels would likely be used
as guidance for any new PSC. Examples of SOPs and BMPs include
avoidance of close approach to visible protected species and habitats
and posting lookouts to alert vessels when a protected species is
sighted to try and avoid areas where protected species are commonly
observed.
    The programmatic approach that the Coast Guard has taken
streamlines the procedures and time involved in consultations for broad
agency programs or numerous similar activities with predictable effects
on listed species and/or critical habitat, thus reducing the amount of
time spent on individual project-by-project consultations. The Coast
Guard has worked collaboratively with the appropriate regulatory
agencies through the consultation process to develop mitigation
measures. The Coast Guard also anticipates working collaboratively with
the appropriate regulatory agencies through the permitting processes to
finalize the mitigation measures. While these are subject to change
(given the timeframe until PSCs are fully operational), the SOPs and
BMPs in use by current icebreakers are as follows:
     Coast Guard Headquarters (HQ), Area, and District
operating procedures and directives for Coast Guard vessels and
aircraft designed to minimize negative interactions with MPS and within
MPAs, including formalized speed and approach guidance around marine
mammals.
     Enforcement of the ESA, MMPA, National Marine Sanctuaries
Act (NMSA), and other pertinent environmental statutes designed to
protect marine protected species and Marine Protected Areas.
     Participation in regional multiagency working groups,
recovery teams, implementation teams, take reduction teams, sanctuary
advisory councils, and task forces.
     Properly training lookouts on marine mammal detection and
identification and maintaining those lookouts aboard vessels at all
times.
     Establishment of Memoranda of Agreement (MOA) with the
National Marine Sanctuaries (NMS) outlining procedures for coordinating
enforcement activities.
     Providing routine surveillance of the NMS concurrently
with other Coast Guard operations, and providing specific targeted or
dedicated law enforcement as appropriate. NMS surveillance and
enforcement is incorporated into routine patrol orders where feasible.
     Subject to availability of resources, providing other
agencies with platforms to conduct critical MPS research and recovery
efforts during stranding and recovery operations.
     Regional Fisheries Training Centers (RFTCs) provide
applicable ESA, MMPA, and NMSA enforcement training to Coast Guard
personnel supporting the MPS mission.
     Participation in the NMFS Marine Mammal Health and
Stranding Response Program (MMHSRP) as a Co-Investigator. Via this
designation, Coast Guard personnel provide the following support to
NMFS: (a) Responding to distressed marine mammals, (b) temporary
restraint or captivity, (c) disentangling, (d) transporting, (e)
attaching tags, and (f) collecting samples.
     Formal guidelines for appropriate disposal of animal
carcasses.
     Providing opportunistic marine mammal sighting information
to the National Marine Mammal Laboratory (NMML) Platforms of
Opportunity Program (POP).

H. Monitoring, Research, and Reporting

    Through its Living Marine Resource program, the Coast Guard is one
of the nation's primary sponsors of scientific research and monitoring
of marine species. Law enforcement operations are also a part of the
Coast Guard mission. Law enforcement missions, including any PSC
support of law enforcement activities, are covered under Title 14
U.S.C. and 6 U.S.C. 468 and 14 U.S.C. 89. The Coast Guard provides
federal law enforcement presence over the entire U.S. Exclusive
Economic Zone, covering nearly 3.4 million square miles of ocean. Coast
Guard activities ensure compliance with fisheries and marine protected
species regulations on domestic vessels; prevent over-fishing, reduce
mortality of protected species, and protect marine habitats by
enforcing domestic fishing laws and regulations; and, enforcing the
MMPA and the ESA.
    The Coast Guard will submit a report documenting any incident
involving protected resources or species to the appropriate regulatory
agency. In these reports, the Coast Guard will describe the level of
training conducted during the reporting period. These reports will also
include information on biological resources that were sighted,
specifically any marine mammals or seabirds, and will include
information on each individual sighted related to mitigation
implementation. If they occur, the Coast Guard will report incidents
involving biological resource, such as bird aircraft strikes, marine
mammal vessel strikes, observed injury or mortality to marine mammals
or sea birds, and injury or mortality of ESA-listed species.
    The Coast Guard and the regulatory agencies will use the
information contained within monitoring, research, activity, and
incident reports when evaluating the effectiveness and practicality of
mitigation and determining if adaptive adjustments to mitigation
measures may be appropriate.

VIII. Agency Consultation and Coordination

    The Coast Guard consulted and coordinated with federal agencies,
including the U.S. Fish and Wildlife Service (USFWS) and the National
Marine Fisheries Service (NMFS), and federally recognized tribes
(Alaska and Washington) in conjunction with actions addressed in the
PSC Final Programmatic EIS.
     Endangered Species Act. The Coast Guard submitted a
request for consultation under section 7 of the ESA in December 2017,
to the USFWS and NMFS for those endangered or threatened species under
their respective jurisdictions. On October 30, 2018 and November 15,
2018, the Coast Guard received a letter from the USFWS and NMFS,
respectively, acknowledging

the start of programmatic formal consultation pursuant to section
7(a)(2) of the ESA. On November 20, 2018, the Coast Guard sent a letter
to the USFWS and NMFS under Section 7(d) of the ESA, indicating that
the Coast Guard would proceed with the contract award and vessel
construction. The Coast Guard determined that the design and
construction of the PSCs would not constitute an irreversible or
irretrievable commitment of resources which would foreclose the
formulation or implementation of reasonable and prudent alternative
measures that may be included in future biological opinions issued by
the Services. The Coast Guard anticipates that any reasonable and
prudent alternatives would focus on the future operations of the PSCs
and not the design and construction of the vessels. Additionally, the
design and build of the PSCs would have no effect on ESA-listed species
or designated critical habitat.
    The Coast Guard anticipates that both NMFS and the USFWS will issue
their programmatic biological opinions on the Proposed Action in 2019.
The Coast Guard recognizes that new information regarding the Proposed
Action and biological resources in the proposed action area may change
before the first PSC is operational (as soon as 2023). As part of the
programmatic consultation process, the Coast Guard will continue to
coordinate with both regulatory agencies and if necessary, reconsult
under section 7 of the ESA if there are any changes in the Proposed
Action or biological resources in the proposed action areas.
     The Marine Mammal Protection Act. The MMPA of 1972, as
amended (16 United States Code [U.S.C.] 1361 et seq.) prohibits, with
certain exceptions, the take of marine mammals in U.S. waters and by
U.S. citizens on the high seas and the importation of marine mammals
and marine mammal products. Coast Guard Instruction [CGD17INST]
16214.2A (U.S. Coast Guard 2011) outlines procedures for avoiding
marine mammals and protected species; reporting marine mammal and
protected species sightings, strandings and injuries; and enforcing the
MMPA and ESA. The Coast Guard is not requesting authorization under
Section 101(a)(5) of the MMPA at this time, because the Proposed Action
discussed in the PSC Final Programmatic EIS will not occur until the
first PSC is delivered and operational (2023); however, the PSC Final
Programmatic EIS may contain information relevant and applicable to
assist with future Coast Guard consultations that are in support of a
request for future incidental take authorizations under the MMPA. As
part of the MMPA, the Coast Guard intends to prepare a Plan of
Cooperation that identifies what measures have been taken and/or will
be taken to minimize any adverse effects on the availability of marine
mammals for subsistence uses.
     Magnuson-Stevens Fishery Conservation and Management Act.
In accordance with the Magnuson-Stevens Act, applicable regulations,
and the Department of Homeland Security and Coast Guard instructions
and directives, the PSC Final Programmatic EIS evaluates the potential
for significant impact or environmental harm from the Proposed Action.
The Coast Guard is not requesting Magnuson-Stevens Act consultation at
this time, because the Proposed Action discussed in the PSC Final
Programmatic EIS concluded that based on the best available
information, no effects to EFH are anticipated. However, since the
first PSC is scheduled to be delivered in 2023; the PSC Final
Programmatic EIS may contain information relevant and applicable to
support future Coast Guard consultations on EFH as required under the
Magnuson-Stevens Act, particularly as new information is obtained.
     The Rights of Federally Recognized Tribes (Indian and
Alaska Native). As part of the MMPA process (see Section 1.5.17), the
Coast Guard intends to prepare a Plan of Cooperation. To meet the Coast
Guard's mission responsibilities in the polar regions, the Coast Guard
plans to establish regular and meaningful communication to consult and
collaborate with Alaska Natives and tribal officials regarding the
Proposed Action. The Coast Guard would not interfere with a tribe's
treaty rights or impinge on access to any area that provides these
resources.

IX. Conclusion

    Based on factors analyzed in the Final PSC Programmatic EIS,
including training and operations objectives, best available science
and modeling data, potential environmental impacts, and input and
expertise of Federal agencies, federally recognized tribes, and the
public, the Coast Guard selects Alternative 1 for implementation.
Alternative 1, the Coast Guard's Preferred Alternative, will fully meet
the Coast Guard's requirements in the polar regions. By implementing
the mitigation measures identified in the Final PSC Programmatic EIS
and associated regulatory documents, and adhering to monitoring
requirements and management plans described herein, the Coast Guard has
adopted all practicable means to avoid or minimize environmental harm
associated with implementing Alternative 1. In addition, the Coast
Guard assessed the effects of Alternative 1 in accordance with
Executive Order 12114 and concluded that there would be no significant
harm to the environment in areas outside of the United States and
possessions.
    This notice is issued under authority of 5 U.S.C. 552(a).

    Dated: March 29, 2019.
Timothy J. Connors,
Captain, U.S. Coast Guard, Program Manager, Polar Icebreaker Program.
[FR Doc. 2019-06468 Filed 4-2-19; 8:45 am]
 BILLING CODE 9110-04-P