[Federal Register Volume 82, Number 161 (Tuesday, August 22, 2017)]
[Rules and Regulations]
[Pages 39665-39671]
[FR Doc No: 2017-17748]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket Number USCG-2015-0051]
RIN 1625-AA00

Safety Zones; Ice Covered Waterways in the Fifth Coast Guard
District

AGENCY: Coast Guard, DHS.

ACTION: Final rule.

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SUMMARY: The Coast Guard is establishing 11 safety zones on certain
navigable waters of the Fifth Coast Guard District. This action is
necessary to promote navigational safety, provide for the safety of
life and property, and facilitate the reasonable demands of commerce
where a threat to navigation exists due to ice covered waterways. This
rule is intended to mitigate the potential threat ice poses to the
maritime public in the Fifth Coast Guard District by implementing
control measures on vessels operating in certain ice covered waterways.

DATES: This rule is effective September 21, 2017.

ADDRESSES: To view documents mentioned in this preamble as being
available in the docket, go to http://www.regulations.gov, type USCG-
2015-0051 in the ``SEARCH'' box and click ``SEARCH.'' Click on Open
Docket Folder on the line associated with this rule.

FOR FURTHER INFORMATION CONTACT: If you have questions on this rule,
call or email Mr. Doug Simpson, Fifth Coast Guard District, U.S. Coast
Guard; telephone<PHONE_NUMBER>, email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Table of Abbreviations

CFR Code of Federal Regulations
DHS Department of Homeland Security
FR Federal Register
NPRM Notice of proposed rulemaking
RNA Regulated Navigation Area
SNPRM Supplemental Notice of Proposed Rulemaking
Sec.  Section
U.S.C. United States Code

II. Background Information and Regulatory History

    On July 9, 2015, the Coast Guard published a notice of proposed
rulemaking (NPRM) titled Regulated Navigation Area; Ice Covered
Waterways in the Fifth Coast Guard District (80 FR 39403). The purpose
of that proposed regulated navigation area (RNA) was to mitigate the
aforementioned potential threat ice poses to the maritime public in the
Fifth Coast Guard District by implementing control measures on vessels
of certain characteristics. We invited comments on our proposed
regulatory action related to that RNA. During the comment period that
ended October 7, 2015, we received a total of six comments coming from
six submitters. No public meeting was requested, and none was held.
    Based on consideration of the comments received in response to the
NPRM and further analysis, the Coast Guard proposed to establish 11
safety

zones on certain navigable waters of the Fifth Coast Guard District
instead of 1 RNA. On February 9, 2017, the Coast Guard published an
SNPRM titled Safety Zones; Ice Covered Waterways in the Fifth Coast
Guard District (82 FR 9978). There we stated why we issued the SNPRM,
replied to the comments received in response to the NPRM, and invited
comments on the proposed regulatory action. During the comment period
on the SNPRM that ended April 10, 2017, we received a total of 11
comments coming from four submitters. No public meeting was requested,
and none was held.

III. Legal Authority and Need for Rule

    The Coast Guard is issuing this rule under authority in 33 U.S.C.
1231. The Coast Guard has determined that during an average or severe
winter, the presence of ice in waterways presents numerous hazards to
vessels. Such hazards include vessels becoming beset or dragged off
course, sinking or grounding and creating hazards to navigation. The
presence of ice in a waterway may hamper a vessel's ability to maneuver
and impose additional loads on a vessel's hull, propulsion system and
appendages. Blockage of sea suctions can cause the main engine cooling
system to overheat, requiring reduced power to be used or the engine to
be shut down completely. Visual aids to navigation may become
submerged, destroyed, or moved off station, potentially misleading the
vessel operator to unsafe waters. Vessels operating in these hazardous
conditions could introduce a clear and present danger to the maritime
public and environment. The purpose of this rule is to mitigate the
potential threat ice poses to the maritime public in the Fifth Coast
Guard District by implementing control measures on vessels operating in
certain ice covered waterways.

IV. Discussion of Comments, Changes, and the Rule

    As noted above, we received 11 comments from four submitters on our
SNPRM published February 9, 2017. One comment was generally supportive
of the rule.
    In response to one comment, we changed the regulatory text that
defined the New Jersey Intracoastal Waterway to clarify the safety
zone's northern boundaries. The safety zone's northern boundary uses
the Fifth Coast Guard District's boundary as defined in 33 CFR
80.501(b)-(c) and 80.502. We changed the rule to define a position for
the entrance to Manasquan Inlet. We also changed the rule to define the
southern boundary of the zone at Cape May Inlet, Cape May, NJ as it is
defined in 33 CFR 80.502 (g). We did not define the width of safety
zone in areas where the New Jersey Intracoastal Waterway passes through
open water areas, as the commenter requested. However, we changed the
regulatory text to explicitly include the navigable waters Manasquan
River at its tributaries, Metedeconk River and its tributaries, Toms
River and Barnegat Bay and its tributaries, Mahahawkin Bay, Little Egg
Harbor, Great Bay to Absecon Bay, Lakes Bay, Great Egg Harbor Bay, Peck
Bay, Ludlam Bay, Townsend Sound, Stites Sound, Great Sound, Grassy
Sound, Taylor Sound, Sunset Lake, Jarvis Sound and Cape May Harbor. The
comment also requested we provide the horizontal Datum. We used NAD 83
and changed the regulatory text of each safety zone to incorporate that
reference.
    Two comments requested that the Coast Guard provide positions for
the bridges that serve as boundaries for the Delaware River, Upper
Delaware River, Baltimore Harbor and approaches, Chesapeake Channel to
Cove Point, Chesapeake Channel between Cove Point and Smith Point, and
Lower Potomac River, Potomac River, and the Upper Potomac River and
Anacostia River zones. As a result, these positions were provided in
the regulatory text where practical. The Coast Guard determined the
positions by plotting the locations on National Oceanic and Atmospheric
Administration (NOAA) nautical charts for the following bridges: Betsy
Ross (state route 90) fixed highway bridge, Trenton--Morrisville (state
route 1) highway bridge, Governor Harry W. Nice (US-301) Memorial
Bridge, Woodrow Wilson Memorial (I-95/I-495) Bridge, the Francis Scott
Key (US-29) Bridge, and the John Philip Sousa (Pennsylvania Avenue SE)
Bridge. The William P. Lane, Jr (US-50/301) Memorial Bridge is curved,
and we find it impractical to sufficiently define this boundary using
latitude and longitude in this rule. Instead, the southern boundary of
the Baltimore Harbor and approaches safety zone and the northern
boundary of the Chesapeake Channel to Cove Point safety zone were
changed to the southernmost edge of the east-bound span of the of the
William P. Lane, Jr (US-50/301) Memorial Bridge.
    One comment requested that we describe the end and turning points
of all the lines that run along the latitude parallel to another
location. We changed the regulatory text of the following safety zones:
Chesapeake Channel to Cove Point: Provided positions for the eastern
and western extent of the southern boundary; Chesapeake Channel between
Cove Point and Smith Point, and Lower Potomac: Provided positions for
the eastern and western extent of the northern boundary, and the
positions defining southern boundary across the Chesapeake Bay and
Tangier Sound; Upper Potomac River and Anacostia River: Provided
position for Hains Point; Chesapeake Bay and Tangier Sound: the
positions defining the eastern and western extent of the northern
boundary across the Chesapeake Bay and Tangier Sound and the eastern
and western extent of the southern boundary along latitude
37[deg]45'00.0'' N.
    One comment proposed additional smaller zones, with the desire to
minimize restriction in portions of the zones that are not impacted by
ice. The Coast Guard does not agree with the addition of the proposed
zones because the operational complexity and feasibility of enacting
those zones is counter to public interest due to the significant amount
of time it would take to effectively manage compliance. However, to
address the comments, we changed the regulatory text in Sec.
165.550(d)(1) to allow each COTP to set ice conditions for any zone in
this rule, or a portion thereof. The COTP may choose not to activate an
entire zone if the ice prevalence and thickness is limited in such a
way it would be too burdensome to activate the entire zone.
    The same commenter stated that there are no provisions for Maryland
Department of Natural Resources to request or obtain a waiver from the
COTP for icebreaking operations. We changed the rule's definition of
public vessels in response to this comment to mean vessels owned or
bareboat chartered and operated by the United States, or by a State or
political subdivision thereof, or by a foreign nation, except when such
vessel is engaged in commercial service. Because this definition
includes vessels engaged in law enforcement, we removed ``engaged in
law enforcement'' from paragraph (d)(1).
    An anonymous comment asserted that the Coast Guard did not evaluate
the impact of a ``business as usual approach'' as an alternative to
this rule. We do not agree with this assertion because the existing
means by which the Coast Guard restricted vessel operations in ice
covered waterways was specifically addressed in the NPRM and SNPRM (82
FR 9978). As stated in the SNPRM, permanent safety zones are the most
appropriate from a regulatory perspective and will ensure consistency
throughout the Fifth Coast Guard District. Furthermore, as stated in
the SNPRM, the Coast Guard finds relying

solely on the authority provided by 33 CFR part 6 is not feasible when
ice presents hazardous conditions. Sole reliance on this authority
involving the protection and security of vessels, harbors, and
waterfront facilities would require the COTP to take individual action
against every vessel desiring to operate in the area, which is counter
to public interest due to the significant amount of time it would take
to issue and administer an effective amount of orders.
    The same anonymous commenter stated that the Coast Guard did not
adequately address ``biophysical impacts,'' details of the ``obvious
cultural and social impacts'' to recreational activities on the water,
environmental justice, and economic impacts of alternatives to the
proposed rule. The comment was vague and lacked sufficient supporting
information needed to determine its validity. We were unable to obtain
clarification from this anonymous commenter regarding the various
issues mentioned, but the Coast Guard believes this rule remains as one
that is a category of actions that do not individually or cumulatively
have a significant effect on the human environment, and the analysis
supporting this determination is available in the docket where
indicated under ADDRESSES. Similarly, one commenter stated that these
regulations would have an impact on persons who make a living by
fishing, crabbing, and oystering on the Chesapeake Bay that act as
small businesses. The Coast Guard received no comments from the Small
Business Administration on this rulemaking, and the Coast Guard
certifies under 5 U.S.C. 605(b) that this rule will not have a
significant economic impact on a substantial number of small entities.
    One comment stated, ``Depending on which shoreline is being used
for measurement, a percentage value of coverage may vary considerably,
which will affect which areas are selected for closure. It is not known
which shoreline standard is being used . . .'' In the context of this
rule, the shoreline is the extent of navigable waters as they are
defined in 33 CFR part 2. We replaced the term shoreline with the term
``the extent of navigable waters'' to clarify the physical reference
point from which ice accumulation will be measured for the purposes of
enforcing the rule. The zones cover large geographic areas so that a
disproportionate amount of ice accumulation along a shoreline will not
have an impact on when the Ice Conditions are set. To clarify the
jurisdictional extents of the safety zones, the term ``and its
tributaries'' was added to Delaware Bay, Delaware River, and Upper
Delaware River zones.
    The same commenter expressed concern that the measurement errors or
tolerance that would affect timings of ``closure events'' is unknown.
No changes were made to this rule based on this comment. The Coast
Guard finds it reasonable to expect that vessel operators can discern
between the ice prevalence and thicknesses that are listed in the
regulatory text in order to determine when restrictions are in place.
The Coast Guard has consistently received reliable and accurate reports
of ice conditions from these same vessel operators in the past.
Furthermore, as stated in the regulatory text, the COTP can notify
mariners of Ice Conditions and associated restrictions via Broadcast
Notice to Mariners and other methods described in 33 CFR 165.7. Vessel
operators that encounter ice covered waterways and are uncertain if the
zone is in effect may contact the cognizant COTP to determine the
waterway status.
    The same commenter asked for a list of ``protected waters'' and
their boundary coordinates. This rule defines ``protected waters'' as,
``sheltered waters such as harbors or basins that present no special
hazards.'' This term is used in this regulation so ``vessels may
transit within protected waters to facilitate icebreaking operations
and protect infrastructure and property without COTP permission.'' The
commenter specifically asked if contractors moving work barges around
bridges would be considered as operating in protected waters and if
fishermen attempting to recover nets or other fisheries gear would be
considered as protecting infrastructure or property. No changes were
made based on this comment. It is not feasible for the Coast Guard to
provide a list of activity in every area that could be considered
``protected waters'' in this rule because the conclusion would vary
depending on the vessel, environment, nature of the activity, and
infrastructure present at the time the Ice Condition is in effect. The
Coast Guard concludes that the present definition provides sufficient
parameters that will promote navigational safety, provide for the
safety of life and property, and facilitate the reasonable demands of
commerce.
    Finally, one commenter requested the Coast Guard institute a
process whereby the final rule is subject to future review and comment
by industry stakeholders at regular intervals to ensure that it remains
appropriate to current conditions. The Coast Guard will monitor the
effectiveness when executing and enforcing the rule, and ensures that
our agency will engage in proper notice-and-comment procedures if we
see a need to change the rule.
    This rule establishes 11 safety zones on the navigable waters of
the Fifth Coast Guard District. This imposes restrictions on vessels
operating within the safety zones or a portion of the zones where a
threat to navigation exists due to ice covered waterways. Vessels
transiting in protected waters, such as within a marina, harbor or
basin, for the purposes of facilitating icebreaking operations and
protecting infrastructure and property would be exempt from the
controls. Vessels capable of operating in the prevailing ice condition
outside of protected waters may be allowed to operate within the safety
zones if granted permission by the cognizant COTP.
    Under this rule, a vessel needs permission from the cognizant COTP
or the District Commander to enter or continue transiting a zone if,
when approaching or after entering a safety zone, the vessel encounters
ice of a given thickness, unless the COTP or the District Commander has
set an ice condition for the zone or a portion of the zone and the
vessel meets the associated requirements to transit the zone.
Descriptions of the three ice conditions and vessel requirements to
transit are listed below. Under:
     Condition One, when 30 percent of a zone is reported
covered with ice 1 to 3 inches thick, only steel hull vessels would be
allowed to transit the zone;
     Condition Two, when 30 to 90 percent of a zone is reported
covered with ice 3 to 9 inches thick, only steel hull vessels with a
1,500 minimum shaft horsepower and a main engine cooling system design
that prevents blockage from ice would be allowed to transit the zone;
and
     Condition Three, when 90 percent or more of a zone is
reported covered with ice 9 inches thick, only steel hull vessels with
a 1,500 minimum shaft horsepower and a main engine cooling system
design that prevents blockage from ice in a vessel convoy would be
allowed to transit the zone.
    For non-steel-hull vessels, entry into or continuing to transit the
zone is prohibited without permission from the cognizant COTP or
District Commander if, when approaching the zone or after entering the
safety zone, the vessel encounters ice of \1/2\-inch or more in
thickness. When this thickness of ice is reached in a zone, non-steel
hull vessels moored or docked in the zone need not exit the zone, but
these vessels may not transit the zone without permission of the
cognizant COTP or District Commander. There is an exemption for vessels
that need to transit in protected

waters, such as within a marina, harbor, or basin, to facilitate
icebreaking operations and protect infrastructure and property. The
regulatory text appears at the end of this document.

V. Regulatory Analyses

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

A. Regulatory Planning and Review

    Executive Orders 12866 and 13563 direct agencies to assess the
costs and benefits of available regulatory alternatives and, if
regulation is necessary, to select regulatory approaches that maximize
net benefits. Executive Order 13563 emphasizes the importance of
quantifying both costs and benefits, of reducing costs, of harmonizing
rules, and of promoting flexibility. Executive Order 13771 directs
agencies to control regulatory costs through a budgeting process. This
rule has not been designated a ``significant regulatory action,'' under
Executive Order 12866. Accordingly, this rule has not been reviewed by
the Office of Management and Budget (OMB), and pursuant to OMB guidance
it is exempt from the requirements of Executive Order 13771.
    This regulatory action determination is based on our assessment
that although this regulation could limit or prevent marine traffic
from transiting certain waterways in the Fifth Coast Guard District,
the effect of this regulation would not be significant because there is
little vessel traffic associated with recreational boating and
commercial fishing during enforcement periods. The Coast Guard
anticipates implementing control measures for limited durations of
time. The cognizant COTP will make notifications of the regulated areas
to the maritime public via Broadcast Notice to Mariners so mariners can
adjust their plans accordingly. Moreover, vessel traffic capable of
operating in such conditions will be allowed to enter into or transit
within the safety zones as specified by the cognizant COTP.

B. Impact on Small Entities

    The Regulatory Flexibility Act of 1980, 5 U.S.C. 601-612, as
amended, requires Federal agencies to consider the potential impact of
regulations on small entities during rulemaking. The term ``small
entities'' comprises small businesses, not-for-profit organizations
that are independently owned and operated and are not dominant in their
fields, and governmental jurisdictions with populations of less than
50,000. The Coast Guard received no comments from the Small Business
Administration on this rulemaking. The Coast Guard certifies under 5
U.S.C. 605(b) that this rule will not have a significant economic
impact on a substantial number of small entities.
    While some owners or operators of vessels intending to transit the
regulated areas may be small entities, for the reasons stated in
section V.A above, this rule would not have a significant economic
impact on a substantial number of small entities.
    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Public Law 104-121), we want to assist small
entities in understanding this rule. If the rule would affect your
small business, organization, or governmental jurisdiction and you have
questions concerning its provisions or options for compliance, please
contact the person listed in the FOR FURTHER INFORMATION CONTACT
section.
    Small businesses may send comments on the actions of Federal
employees who enforce, or otherwise determine compliance with, Federal
regulations to the Small Business and Agriculture Regulatory
Enforcement Ombudsman and the Regional Small Business Regulatory
Fairness Boards. The Ombudsman evaluates these actions annually and
rates each agency's responsiveness to small business. If you wish to
comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR
(1-888-734-3247). The Coast Guard will not retaliate against small
entities that question or complain about this rule or any policy or
action of the Coast Guard.

C. Collection of Information

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

D. Federalism and Indian Tribal Governments

    A rule has implications for federalism under Executive Order 13132,
Federalism, if it has a substantial direct effect on the States, on the
relationship between the national government and the States, or on the
distribution of power and responsibilities among the various levels of
government. We have analyzed this rule under that Order and have
determined that it is consistent with the fundamental federalism
principles and preemption requirements described in Executive
Order13132.
    Also, this rule does not have tribal implications under Executive
Order 13175, Consultation and Coordination with Indian Tribal
Governments, because it does not have a substantial direct effect on
one or more Indian tribes, on the relationship between the Federal
Government and Indian tribes, or on the distribution of power and
responsibilities between the Federal Government and Indian tribes. If
you believe this rule has implications for federalism or Indian tribes,
please contact the person listed in the FOR FURTHER INFORMATION CONTACT
section.

E. Unfunded Mandates Reform Act

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

F. Environment

    We have analyzed this rule under Department of Homeland Security
Management Directive 023-01 and Commandant Instruction M16475.lD, which
guide the Coast Guard in complying with the National Environmental
Policy Act of 1969(42 U.S.C. 4321-4370f), and have determined that this
action is one of a category of actions that do not individually or
cumulatively have a significant effect on the human environment. This
rule involves establishing safety zones. Normally such actions are
categorically excluded from further review under paragraph 34(g) of
Figure 2-1 of the Commandant Instruction. An environmental analysis
checklist and a Record of Environmental Consideration (REC) supporting
this determination are available in the docket where indicated under
ADDRESSES. We seek any comments or information that may lead to the
discovery of a significant environmental impact from this rule.

G. Protest Activities

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

jeopardizing the safety or security of people, places or vessels.

List of Subjects in 33 CFR Part 165

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

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

PART 165--REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS

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

    Authority:  33 U.S.C. 1231; 50 U.S.C. 191; 33 CFR 1.05-1, 6.04-
1, 6.04-6, and 160.5; Department of Homeland Security Delegation No.
0170.1.

0
2. Add Sec.  165.550 to read as follows:

Sec.  165.550   Safety Zones; Ice covered waterways within the Fifth
Coast Guard District.

    (a) Regulated areas. The following areas are established as safety
zones:
    (1) Coast Guard Sector Delaware Bay--COTP Zone. (i) Delaware Bay:
All navigable waters of Delaware Bay and Delaware River in an area
bound to the south by a line drawn across the entrance to Delaware Bay,
commencing at Cape May Light (LLNR 155) latitude 38[deg]55'59'' N.,
longitude 074[deg]57'37'' W.; thence southwest to Cape Henlopen,
latitude 38[deg]48'20.3'' N., longitude 075[deg]05'44.5'' W. The
regulated area is bound to the north by a line drawn across the
Delaware River, commencing at Liston Point, DE, latitude
39[deg]25'03.07'' N., longitude 075[deg]32'25.5'' W.; thence northeast
to the extent of navigable waters at Hope Creek Jetty, latitude
39[deg]27'05.04'' N., longitude 075[deg]30'12.55'' W. (Datum NAD 83)
    (ii) Delaware River: All navigable waters of Delaware River and its
tributaries, in an area bound to the south by a line drawn across the
Delaware River, commencing at Liston Point, DE, latitude
39[deg]25'03.07'' N., longitude 075[deg]32'25.5'' W.; thence northeast
to the extent of navigable waters at Hope Creek Jetty, latitude
39[deg]27'05.04'' N., longitude 075[deg]30'12.55'' W., including the
navigable waters of the Salem River, Christina River, and Schuylkill
River. The regulated area is bound to the north by a line drawn across
the Delaware River at the Betsy Ross (state route 90) fixed highway
bridge from latitude 39[deg]59'10.43'' N, longitude 075[deg]04'11.03''
W to latitude 39[deg]58'58.65'' N., longitude 075[deg]03'43.23'' W.
(Datum NAD 83)
    (iii) Upper Delaware River: All navigable waters of Delaware River
and its tributaries in an area bound to the south by a line drawn
across the Delaware River at the Betsy Ross (state route 90) fixed
highway bridge from latitude 39[deg]59'10.43'' N., longitude
075[deg]04'11.03'' W. to latitude 39[deg]58'58.65'' N., longitude
075[deg]03'43.23'' W. The regulated area is bound to the north by a
line drawn across the Delaware River at the Trenton--Morrisville (state
route 1) highway bridge from latitude 40[deg]12'29.86'' N., longitude
074[deg]46'11.00'' W. to latitude 40[deg]12'34.93'' N., longitude
74[deg]46'00.63'' W. (Datum NAD 83)
    (iv) New Jersey Intracoastal Waterway: All navigable waters of New
Jersey Intracoastal Waterway (NJICW), bounded by the area defined by 33
CFR 80.501(b)-(c) and Sec.  80.502, commencing at the entrance to
Manasquan Inlet at latitude 40[deg]06'03'' N., longitude 74[deg]01'55''
W., continuing the entire length of NJICW to include the navigable
waters Manasquan River at its tributaries, Metedeconk River and its
tributaries, Toms River and Barnegat Bay and its tributaries,
Mahahawkin Bay, Little Egg Harbor, Great Bay to Absecon Bay, Lakes Bay,
Great Egg Harbor Bay, Peck Bay, Ludlam Bay, Townsend Sound, Stites
Sound, Great Sound, Grassy Sound, Taylor Sound, Sunset Lake, Jarvis
Sound and Cape May Harbor. This regulated area terminates in the east
at line drawn across the seaward extremity of Cape May Inlet, Cape May,
NJ and in the west at line drawn across the entrance to the Cape May
Canal from latitude 38[deg]58'03.72'' N., longitude 074[deg]58'00.00''
W. to latitude 38[deg]57'57.00'' N., longitude 074[deg]58'00.80'' W.
(Datum NAD 83)
    (2) Coast Guard Sector Maryland-National Capital Region- COTP Zone.
(i) Head of Chesapeake Bay to C&D Canal: All navigable waters of the
Upper Chesapeake Bay and its tributaries, bound to the north by a line
drawn from Hylands Point, MD, latitude 39[deg]30'18'' N., longitude
075[deg]55'37'' W.; thence east across Elk River to the shoreline at
Old Town Point Wharf, MD, latitude 39[deg]30'11.3'' N., longitude
075[deg]54'57.1'' W. The regulated area is bound to the south by a line
drawn across the Chesapeake Bay, commencing at North Point, MD,
latitude 39[deg]11'43.7'' N., longitude 076[deg]26'32.8'' W.; thence
east to the extent of navigable waters at Swan Point, latitude
39[deg]08'41.7'' N., longitude 076[deg]16'42.4'' W. (Datum NAD 83)
    (ii) Baltimore Harbor and approaches: All navigable waters of the
Chesapeake Bay and its tributaries, bound to the north by a line drawn
across the Chesapeake Bay, commencing at North Point, MD, latitude
39[deg]11'43.7'' N., longitude 076[deg]26'32.8'' W.; thence east to the
shoreline at Swan Point, latitude 39[deg]08'41.7'' N., longitude
076[deg]16'42.4'' W. The regulated area is bound to the south by the
southernmost edge of the east-bound span of the William P. Lane, Jr
(US-50/301) Memorial Bridge. (Datum NAD 83)
    (iii) Chesapeake Channel to Cove Point: All navigable waters of the
Chesapeake Bay and its tributaries, bound to the north by the
southernmost edge of the east-bound span of the William P. Lane, Jr
(US-50/301) Memorial Bridge. The regulated area is bound to the south
by a line drawn across the Chesapeake Bay commencing in Cove Point in
Calvert County, MD at latitude 38[deg]23'10.5'' N., longitude
076[deg]22'52.9''W. and ending at a point in Meekins Neck at latitude
38[deg]23'14.9'' N., longitude 076[deg]16'48.3'' W. (Datum NAD 83)
    (iv) Chesapeake Channel between Cove Point and Smith Point, and
Lower Potomac River: All navigable waters of Chesapeake Bay and its
tributaries, bound to the north by a line drawn across the Chesapeake
Bay commencing in Cove Point in Calvert County, MD at latitude
38[deg]23'10.5'' N., longitude 076[deg]22'52.9'' W. and ending at a
point in Meekins Neck at latitude 38[deg]23'10.5'' N., longitude
076[deg]16'48.3'' W.; and all navigable waters of the Potomac River
bound to the north by a line drawn across the Potomac River at the
Governor Harry W. Nice (US-301) Memorial Bridge from latitude
38[deg]21'33.30'' N., longitude 077[deg]00'51.41''W. to latitude
38[deg]21'48.22'' N., longitude 76[deg]58'59.83'' W., connecting King
George County, VA and Charles County, MD. (Datum NAD 83)
    (v) Potomac River: All navigable waters of the Potomac River, bound
to the north by a line drawn across the Potomac River at the Woodrow
Wilson Memorial (I-95/I-495) Bridge from latitude 38[deg]47'32.38'' N.,
longitude 077[deg]02'22.15'' W. to latitude 38[deg]47'33.83'' N.,
longitude 077[deg]01'30.58'' W., connecting Alexandria, VA and Prince
George's County, MD. The regulated area is bound to the south by a line
drawn across the Potomac River at the Governor Harry W. Nice (US-301)
Memorial Bridge from latitude 38[deg]21'33.30'' N., longitude
077[deg]00'51.41''W. to latitude 38[deg]21'48.22'' N., longitude
76[deg]58'59.83'' W., connecting King George County, VA and Charles
County, MD. (Datum NAD 83)
    (vi) Upper Potomac River and Anacostia River: All navigable waters
of the Potomac River, bound to the north by a line drawn across the
Potomac River at the Francis Scott Key (US-29) Bridge from latitude
38[deg]54'03.51'' N.,

longitude 077[deg]04'13.18'' W. to latitude 38[deg]54'13.68'' N.,
longitude 077[deg]04'08.46'' W., connecting Rosslyn, VA and Georgetown,
Washington, DC, and bound to the south by a line drawn across the
Potomac River at the Woodrow Wilson Memorial (I-95/I-495) Bridge from
latitude 38[deg]47'32.38'' N., longitude 077[deg]02'22.15'' W. to
latitude 38[deg]47'33.83'' N., longitude 077[deg]01'30.58'' W.,
connecting Alexandria, VA and Prince George's County, MD. All navigable
waters of Anacostia River and Washington Channel bound to the north by
a line drawn across the Anacostia River at the John Philip Sousa
(Pennsylvania Avenue SE) Bridge, latitude 38[deg]52'38.97'' N.,
longitude 076[deg]58'46.48'' W. to latitude 38[deg]52'34.08'' N.,
longitude 076[deg]58'36.61'' W. and bound to the south by a line drawn
across the mouth of the Anacostia River, from Hains Point at latitude
38[deg] 51' 24.34'' N., longitude 077[deg] 1' 20.14'' W., south across
Anacostia River Channel to Giesboro Point at latitude 38[deg]50'51''
N., longitude 077[deg]01'14'' W. at Joint Base Anacostia-Bolling
military installation. (Datum NAD 83)
    (3) Coast Guard Sector Hampton Roads--COTP Zone--(i) Chesapeake Bay
and Tangier Sound: All navigable waters of Chesapeake Bay, and its
tributaries, bound to the north by a line drawn along the Maryland-
Virginia boundary, commencing in Virginia at latitude 37[deg]53'11''
N., longitude 76[deg]14'15'' W., thence east along the Maryland-
Virginia boundary as it proceeds across the Chesapeake Bay and Pocomoke
River, ending at the point latitude 37[deg]59'39.8'' N., longitude
75[deg]37'27.4'' W. The regulated area is bound to the south by a line
drawn across the Chesapeake Bay along latitude 37[deg]45'00.0'' N.,
commencing in Northumberland County, VA at latitude 37[deg]45'00.00''
N., longitude 76[deg]18'44.32'' W. and ending in Chesconessex, in
Accomack County, VA at latitude 37[deg]45'00.00'' N., longitude
75[deg]48'39.53''W. (Datum NAD 83)
    (ii) [Reserved]
    (b) Definitions. As used in this section:
    Convoy means a group of vessels led by U.S. Coast Guard assets or
COTP-designated vessels to assist vessels moving through the ice.
    COTP means the Coast Guard Captain of the Port with jurisdiction
over the geographic area as defined in 33 CFR subpart 3.25.
    Designated representative means any Coast Guard commissioned,
warrant, or petty officer who has been authorized by the cognizant COTP
to assist in enforcing the safety zones described in paragraph (a) of
this section.
    Horsepower means the total maximum continuous shaft horsepower of a
vessel's main propulsion machinery.
    Ice Condition One means when the COTP or District Commander has
received reports that approximately 30 percent of a safety zone defined
in paragraph (a) has been covered with ice whose thickness is
approximately 1 to 3 inches.
    Ice Condition Two means when the COTP or District Commander has
received reports that approximately 30 percent to 90 percent of a
safety zone defined in paragraph (a) has been covered with ice whose
thickness is approximately 3 to 9 inches.
    Ice Condition Three means when the COTP or District Commander has
received reports that approximately 90 percent or more of a safety zone
defined in paragraph (a) has been covered with ice whose thickness is 9
inches or thicker.
    Protected waters means sheltered waters such as harbors or basins
that present no special hazards.
    Public vessel means vessels owned or bareboat chartered and
operated by the United States, or by a State or political subdivision
thereof, or by a foreign nation, except when such vessel is engaged in
commercial service.
    (c) Regulations--(1) Non-steel hull vessels. Non-steel hull vessels
may not enter or transit within a safety zone described in paragraph
(a) of this section without permission from the cognizant COTP or
District Commander if, when approaching the zone or after entering the
zone, the vessel encounters ice of \1/2\-inch or more in thickness.
When ice in a zone is \1/2\-inch thick or more, non-steel hull vessels
moored or docked in the zone need not exit the zone. Except for as
described in paragraph (d)(4), non-steel hull vessels may not enter or
transit the zone without permission of the cognizant COTP or District
Commander.
    (2) Steel hull vessels. Except as provided in paragraph (d)(1) of
this section, steel hull vessels may not enter or transit within a
safety zone described in paragraph (a) of this section without
permission from the cognizant COTP or District Commander in the
following circumstances:
    (i) The vessel has less than 1,500 minimum shaft horsepower and
encounters ice 1 inch or more thick.
    (ii) The vessel has a 1,500 minimum shaft horsepower and a main
engine cooling system design that prevents blockage from ice and
encounters ice 3 inches or more thick.
    (iii) The vessel is part of a vessel convoy and has a 1,500 minimum
shaft horsepower and a main engine cooling system design that prevents
blockage from ice and encounters ice 9 inches or more thick.
    (d) Permission to enter or transit. (1) The COTP may set ice
conditions, as defined in paragraph (b) of this section, for any zone
described in paragraph (a) of this section, or a portion thereof, and
announce those conditions via Broadcast Notice to Mariners and other
methods described in 33 CFR 165.7. Steel hull vessels prohibited from
entering or transiting a safety zone under paragraph (c) of this
section may nonetheless enter or continue transiting the safety zone
without contacting the COTP if the vessel is a public vessel or the
COTP has set an ice condition for the safety zone and the vessel meets
these restrictions:
    (i) Ice Condition One. Only steel hull vessels may enter, operate
in, or transit though a safety zone when Ice Condition One has been set
for that zone.
    (ii) Ice Condition Two. Only steel hull vessels with a 1,500
minimum shaft horsepower and a main engine cooling system design that
prevents blockage from ice, may enter, operate in, or transit though a
safety zone when Ice Condition Two has been set for that zone.
    (iii) Ice Condition Three. Only steel hull vessels with a 1,500
minimum shaft horsepower and a main engine cooling system design that
prevents blockage from ice, and that are part of a vessel convoy, may
enter, operate in, or transit though a safety zone when Ice Condition
Three has been set for that zone. These vessels may only transit an Ice
Condition Three zone during daylight hours.
    (2) Vessels prohibited from entering or transiting a safety zone
under paragraph (c) of this section may request permission to enter or
continue transiting by contacting the cognizant COTP on VHF-FM channel
16 (156.8 MHZ) or via telephone, as follows:
    (i) COTP Delaware Bay:<PHONE_NUMBER>.
    (ii) COTP Maryland-National Capital Region:<PHONE_NUMBER>.
    (iii) COTP Hampton Roads:<PHONE_NUMBER>.
    (3) Vessels granted permission to enter, operate in, or transit
though a safety zone must do so in accordance with the directions
provided by the cognizant COTP or designated representative.
    (4) Vessels may transit within protected waters to facilitate
icebreaking

operations and protect infrastructure and property without COTP
permission.
    (e) Enforcement. The Coast Guard vessels enforcing this section can
be contacted on marine band radio VHF-FM channel 16 (156.8 MHZ). The
cognizant COTP and his or her designated representatives can be
contacted at telephone number listed in paragraph (d)(2) of this
section.

    Dated: August 2, 2017.
Meredith L. Austin,
Rear Admiral, U.S. Coast Guard, Commander, Fifth Coast Guard District.
[FR Doc. 2017-17748 Filed 8-21-17; 8:45 am]
 BILLING CODE 9110-04-P


[Federal Register Volume 80, Number 28 (Wednesday, February 11, 2015)]
[Notices]
[Pages 7612-7614]
[FR Doc No: 2015-02802]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-D-0630]

Safety Considerations To Mitigate the Risks of Misconnections
With Small-Bore Connectors Intended for Enteral Applications; Guidance
for Industry and Food and Drug Administration Staff; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of the guidance entitled ``Safety Considerations to
Mitigate the Risks of Misconnections with Small-Bore Connectors
Intended for Enteral Applications.'' The use of common connector
designs, such as Luer connectors, has led to unintended connections
between devices that have different intended uses and has resulted in
serious and sometimes fatal consequences to patients. This guidance
provides recommendations to manufacturers regarding the expectations
for design and testing of small-bore connectors intended for enteral
applications (``enteral devices''). FDA is making these recommendations
to reduce the risk of unintended connections between enteral and non-
enteral devices.

DATES: Submit either electronic or written comments on this guidance at
any time. General comments on Agency guidance documents are welcome at
any time.

ADDRESSES: An electronic copy of the guidance document is available for
download from the Internet. See the SUPPLEMENTARY INFORMATION section
for information on electronic access to the guidance. Submit written
requests for a single hard copy of the guidance document entitled
``Safety Considerations to Mitigate the Risks of Misconnections with
Small-Bore Connectors Intended for Enteral Applications'' to the Office
of the Center Director, Guidance and Policy Development, Center for
Devices and Radiological Health, Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 66, Rm. 5431, Silver Spring, MD 20993-0002.
Send one self-addressed adhesive label to assist that office in
processing your request.
    Submit electronic comments on the guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852. Identify comments with the docket number
found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Priya Venkataraman-Rao, Center for
Devices and Radiological Health, Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 66, Rm. G222, Silver Spring, MD 20993-0002,
301-796-6243.

SUPPLEMENTARY INFORMATION:

I. Background

    Numerous publications regarding patient injury and death from
tubing and catheter misconnections indicate that reports of
misconnections have increased in frequency over the past several years.
On July 9, 2010, FDA issued a letter to healthcare professionals,
hospital purchasing departments, and manufacturers of enteral feeding
tubes regarding Luer lock misconnections (Ref. 1). FDA advised
manufacturers to assess the risks of misconnections for their devices
and provide proposed solutions with validation for premarket review. At
that time, some manufacturers were using color-coding and labeling to
reduce the risk of misconnections; others were creating proprietary
connectors designed to be incompatible with devices for non-enteral
applications (``non-enteral devices''). However, recent reports of
adverse events have demonstrated that reliance on color-coding and
tagging of enteral devices alone cannot adequately mitigate the risk of
misconnections, especially with similarly color-coded intravenous PICC
(percutaneously inserted central catheter) lines with Luer connectors.
    This guidance provides updated recommendations to manufacturers of
small-bore connectors intended for enteral applications. The guidance
recommends that manufacturers: (1) Design and test enteral connectors
based upon Association for the Advancement of Medical Instrumentation
(AAMI)/CN3:2014 (PS), ``Small-bore connectors for liquids and gases in
healthcare applications--Part 3: Connectors for enteral applications''
and AAMI/CN20:2014 (PS), ``Small-bore connectors for liquids and gases
in healthcare applications--Part 20: Common test methods''; (2) for
connectors that do not meet AAMI/CN3:2014 (PS), design and test
connectors based upon the AAMI/American National Standards Institute
(ANSI)/International Organization for Standardization (ISO) 80369-1
standard ``Small-bore connectors for liquids and gases in healthcare
applications--Part 1:

General requirements''; (3) no longer rely solely on color-coding,
labeling, and tagging to prevent misconnections; and (4) perform and
document risk assessments to demonstrate that the proposed design and
testing have effectively mitigated the risk of the enteral connector
misconnecting to non-enteral devices.
    Elsewhere in this issue of the Federal Register, we are announcing
a publication containing modifications to the list of standards that
FDA recognizes for use in premarket reviews (``FDA Recognized Consensus
Standards''). Specifically, this publication announces the addition of
a list of recognized standards that are relevant to safety
considerations to mitigate the risks of misconnections with small-bore
connectors intended for enteral applications. This publication,
entitled ``Modifications to the List of Recognized Standards,
Recognition List Number: 039'' (``Recognition List Number: 039''), will
assist manufacturers who elect to declare conformity with consensus
standards to meet certain requirements for medical devices,
specifically small-bore connectors for enteral applications.
    In the Federal Register of July 27, 2012 (77 FR 44256), FDA
announced the availability of the draft guidance document. We invited
interested persons to comment by October 25, 2012. Seven sets of
comments were received and offered strong support for the finalization
of this guidance as part of a continued effort to reduce the likelihood
of incidents involving unintended connections between connectors with
different intended uses. Multiple comments also applauded FDA for
collaborating with the standards organizations to address this issue.
    The comments also noted the potential drawbacks of aligning the
recommended testing with the current version of the AAMI/ANSI/ISO
80369-1 standard. Its methodologies, particularly those in Annex B,
seek to demonstrate that each proposed enteral connector is physically
incompatible with non-enteral devices. However, ISO is proposing
substantial changes for future versions that could affect the
recommended testing. FDA acknowledges this potential drawback; however,
the current version of 80369-1 was the available reference at the time.
As noted above, additional consensus standards relating to the design
and testing of small-bore connectors intended for enteral applications
have been published and recognized. Therefore, the guidance has been
modified accordingly to reference and align with these recognized
standards.
    Multiple comments also suggested that the description of included
and excluded devices be modified and clarified, and gave examples for
consideration. The guidance has been modified accordingly. Several
comments requested language and definition changes to provide more
clarity and consistency with the published standard, which FDA has
considered and incorporated as appropriate. Lastly, due primarily to
space considerations on the label affixed to a device, multiple
comments expressed concern regarding FDA's recommendation to eliminate
the use of shortened terms such as ``enteral-only'' or ``non-IV'' in
favor of more descriptive labeling. FDA has considered these comments
and recommends that the device's instructions for use, as opposed to
its affixed label, fully describe the subject connector's
interconnectability. The instructions for use will afford adequate
space for the recommended longer phrases describing the devices to
which the subject connector can and cannot connect. However, for
connectors for which non-interconnectability has been demonstrated, the
product design could also incorporate color-coding, labeling, and
tagging or imprinting on the connector.

II. Significance of Guidance

    This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
Agency's current thinking on mitigating the risks of misconnections
with small-bore connectors intended for enteral applications. It does
not create or confer any rights for or on any person and does not
operate to bind FDA or the public. An alternative approach may be used
if such approach satisfies the requirements of the applicable statute
and regulations.

III. Electronic Access

    Persons interested in obtaining a copy of the guidance may do so by
downloading an electronic copy from the Internet. A search capability
for all Center for Devices and Radiological Health guidance documents
is available at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. Guidance
documents are also available at http://www.regulations.gov. Persons
unable to download an electronic copy of ``Safety Considerations to
Mitigate the Risks of Misconnections with Small-Bore Connectors
Intended for Enteral Applications'' may send an email request to<EMAIL_ADDRESS>to receive an electronic copy of the document.
Please use the document number 1784 to identify the guidance you are
requesting.

IV. Paperwork Reduction Act of 1995

    This guidance refers to previously approved collections of
information found in 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 (the PRA) (44 U.S.C. 3501-
3520). The collections of information in 21 CFR part 820 have been
approved under OMB control number 0910-0073; the collections of
information in 21 CFR part 812 have been approved under OMB control
number 0910-0078; the collections of information in 21 CFR part 807,
subpart E have been approved under OMB control number 0910-0120; the
collections of information in 21 CFR 56.115 have been approved under
OMB control number 0910-0130; the collections of information found in
21 CFR part 814 have been approved under OMB control number 0910-0231;
the collections of information in 21 CFR part 803 have been approved
under OMB control number 0910-0437; and the collections of information
in 21 CFR part 801 have been approved under OMB control number 0910-
0485.
    The labeling provisions of this guidance are not subject to review
by OMB because they do not constitute a ``collection of information''
under the PRA. Rather, the recommended enteral connector labeling is a
public disclosure of information originally supplied by the Federal
Government to the recipient for the purpose of disclosure to the public
(see 5 CFR 1320.3(c)(2)).

V. Comments

    Interested persons may submit either electronic comments regarding
this document to http://www.regulations.gov or written comments to the
Division of Dockets Management (see ADDRESSES). It is only necessary to
send one set of comments. Identify comments with the docket number
found in brackets in the heading of this document. Received comments
may be seen in the Division of Dockets Management between 9 a.m. and 4
p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov.

VI. References

    The following reference has been placed on display in the Division
of Dockets Management (see ADDRESSES) 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. (FDA has verified the Web
site addresses in this reference section, but FDA is not responsible
for any subsequent changes to the Web sites after this document
publishes in the Federal Register.)

    1. FDA Center for Devices and Radiological Health, Letters to
Industry Page, ``Letter to Manufacturers of Enteral Feeding Tubes,''
(http://www.fda.gov/downloads/MedicalDevices/ResourcesforYou/Industry/UCM218631.pdf).

    Dated: February 5, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-02802 Filed 2-10-15; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 87, Number 221 (Thursday, November 17, 2022)]
[Rules and Regulations]
[Pages 68891-68895]
[FR Doc No: 2022-24991]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2022-0682; Project Identifier MCAI-2021-01271-T;
Amendment 39-22171; AD 2022-19-02]
RIN 2120-AA64

Airworthiness Directives; Airbus SAS Airplanes

AGENCY: Federal Aviation Administration (FAA), Department of
Transportation (DOT).

ACTION: Final rule.

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

SUMMARY: The FAA is superseding Airworthiness Directive (AD) 2016-10-
08, AD 2017-05-10, and AD 2019-01-05, which applied to certain Airbus
SAS Model A330-200, -200 Freighter, and -300 series airplanes; and AD
2019-20-13, which applied to certain Airbus SAS Model A330-200, A330-
200 Freighter, A330-300, A340-200, A340-300, A340-500, and A340-600
series airplanes. AD 2016-10-08 required determining the flight cycles
accumulated on certain trimmable horizontal stabilizer actuators
(THSAs), and replacing the THSA if necessary. AD 2017-05-10, AD 2019-
01-05, and AD 2019-20-13 required revising the existing maintenance or
inspection program, as applicable. This AD was prompted by a
determination that new or more restrictive airworthiness limitations
are necessary. This AD requires revising the existing maintenance or
inspection program, as applicable, to incorporate additional new or
more restrictive airworthiness limitations, as specified in a European
Union Aviation Safety Agency (EASA) AD, which is incorporated by
reference. The FAA is issuing this AD to address the unsafe condition
on these products.

DATES: This AD is effective December 22, 2022.
    The Director of the Federal Register approved the incorporation by
reference of a certain publication listed in this AD as of December 22,
2022.
    The Director of the Federal Register approved the incorporation by
reference of a certain other publication listed in this AD as of June
24, 2016 (81 FR 31844, May 20, 2016).
    The Director of the Federal Register approved the incorporation by
reference of a certain other publication listed in this AD as of
November 26, 2019 (84 FR 56378, October 22, 2019).

ADDRESSES:
    AD Docket: You may examine the AD docket at regulations.gov under
Docket No. FAA-2022-0682; or in person at Docket Operations between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays. The AD
docket contains this final rule, the mandatory continuing airworthiness
information (MCAI), any comments received, and other information. The
address for Docket Operations is U.S. Department of Transportation,
Docket Operations, M-30, West Building Ground Floor, Room W12-140, 1200
New Jersey Avenue SE, Washington, DC 20590.
    Material Incorporated by Reference:
     For EASA AD 2021-0250, contact EASA, Konrad-Adenauer-Ufer
3, 50668 Cologne, Germany; telephone +49 221 8999 000; email
[email protected]; internet easa.europa.eu. You may find this EASA AD
on the EASA website at ad.easa.europa.eu.
     For Airbus SAS service information, contact Airbus SAS,
Airworthiness Office--EAL, Rond-Point Emile Dewoitine No: 2, 31700
Blagnac Cedex, France; telephone +33 5 61 93 36 96; fax +33 5 61 93 45
80; email airbus.com">[email protected]airbus.com; internet airbus.com.
     You may view this service information at the FAA,
Airworthiness Products Section, Operational Safety Branch, 2200 South
216th St., Des Moines, WA. For information on the

availability of this material at the FAA, call<PHONE_NUMBER>. It is also
available at regulations.gov under Docket No. FAA-2022-0682.

FOR FURTHER INFORMATION CONTACT: Vladimir Ulyanov, Aerospace Engineer,
Large Aircraft Section, FAA, International Validation Branch, 2200
South 216th St., Des Moines, WA 98198; telephone<PHONE_NUMBER>; email
[email protected].

SUPPLEMENTARY INFORMATION:

Background

    EASA, which is the Technical Agent for the Member States of the
European Union, has issued EASA AD 2021-0250, dated November 17, 2021
(EASA AD 2021-0250) (also referred to as the MCAI), to correct an
unsafe condition for all Airbus SAS Model A330-201, -202, -203, -223,
and -243 airplanes; Model A330-223F and -243F airplanes; Model A330-
301, -302, -303, -321, -322, -323, -341, -342, and -343 airplanes;
Model A330-841 airplanes; and Model A330-941 airplanes.
    The FAA issued a notice of proposed rulemaking (NPRM) to amend 14
CFR part 39 to supersede AD 2016-10-08, Amendment 39-18519 (81 FR
31844, May 20, 2016) (AD 2016-10-08); AD 2017-05-10, Amendment 39-18821
(82 FR 13379, March 13, 2017) (AD 2017-05-10); AD 2019-01-05, Amendment
39-19544 (84 FR 4310, February 15, 2019) (AD 2019-01-05); and AD 2019-
20-13, Amendment 39-19766 (84 FR 56378, October 22, 2019) (AD 2019-20-
13). AD 2016-10-08, AD 2017-05-10, and AD 2019-01-05, applied to
certain Airbus SAS Model A330-200, -200 Freighter, and -300 series
airplanes, and AD 2019-20-13 applied to certain Airbus SAS Model A330-
200, A330-200 Freighter, A330-300, A340-200, A340-300, A340-500, and
A340-600 series airplanes. The NPRM published in the Federal Register
on June 23, 2022 (87 FR 37454). The NPRM was prompted by a
determination that new or more restrictive airworthiness limitations
are necessary. The NPRM proposed to require revising the existing
maintenance or inspection program, as applicable, to incorporate
additional new or more restrictive airworthiness limitations, as
specified in EASA AD 2021-0250.
    The FAA is issuing this AD to address the failure of system
components, which could reduce the controllability of the airplane. See
the MCAI for additional background information.

Discussion of Final Airworthiness Directive

Comments

    The FAA received a comment from the Air Line Pilots Association,
International (ALPA) who supported the NPRM without change.

Conclusion

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

Related Service Information Under 1 CFR Part 51

    EASA AD 2021-0250 specifies airworthiness limitations for system
equipment maintenance requirements.
    This AD also requires Airbus Service Bulletin A330-27-3199, dated
July 15, 2014, which the Director of the Federal Register approved for
incorporation by reference as of June 24, 2016 (81 FR 31844, May 20,
2016).
    This AD also requires Airbus A330 Airworthiness Limitations Section
(ALS) Part 4, System Equipment Maintenance Requirements (SEMR),
Revision 07, dated October 15, 2018, which the Director of the Federal
Register approved for incorporation by reference as of November 26,
2019 (84 FR 56378, October 22, 2019).
    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.

Costs of Compliance

    The FAA estimates that this AD affects 138 airplanes of U.S.
registry. The FAA estimates the following costs to comply with this AD:
    The FAA estimates the total cost per operator for the retained
actions from AD 2016-10-08 to be $255 per product (3 work-hours x $85
per work-hour) for inspecting the THSA for a total cost for U.S.
operators of $35,190. The retained on-condition cost for AD 2016-10-08
is $724,511 per product (23 work-hours x $85 per work-hour). The FAA
estimates the total cost per operator for the retained actions from AD
2019-20-13 to be $7,650 (90 work-hours x $85 per work-hour).
    The FAA has determined that revising the existing maintenance or
inspection program takes an average of 90 work-hours per operator,
although the agency recognizes that this number may vary from operator
to operator. Since operators incorporate maintenance or inspection
program changes for their affected fleet(s), the FAA has determined
that a per-operator estimate is more accurate than a per-airplane
estimate.
    The FAA estimates the total cost per operator for the new actions
to be $7,650 (90 work-hours x $85 per work-hour).

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. Subtitle I, section 106, describes the
authority of the FAA Administrator. Subtitle VII: Aviation Programs,
describes in more detail the scope of the Agency's authority.
    The FAA is issuing this rulemaking under the authority described in
Subtitle VII, Part A, Subpart III, Section 44701: General requirements.
Under that section, Congress charges the FAA with promoting safe flight
of civil aircraft in air commerce by prescribing regulations for
practices, methods, and procedures the Administrator finds necessary
for safety in air commerce. This regulation is within the scope of that
authority because it addresses an unsafe condition that is likely to
exist or develop on products identified in this rulemaking action.

Regulatory Findings

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

List of Subjects in 14 CFR Part 39

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

The Amendment

    Accordingly, under the authority delegated to me by the
Administrator,

the FAA amends 14 CFR part 39 as follows:

PART 39--AIRWORTHINESS DIRECTIVES

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

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

Sec.  39.13   [Amended]

0
2. The FAA amends Sec.  39.13 by:
0
a. Removing Airworthiness Directive (AD) AD 2016-10-08, Amendment 39-
18519 (81 FR 31844, May 20, 2016); AD 2017-05-10, Amendment 39-18821
(82 FR 13379, March 13, 2017); AD 2019-01-05, Amendment 39-19544 (84 FR
4310, February 15, 2019); and AD 2019-20-13, Amendment 39-19766 (84 FR
56378, October 22, 2019); and
0
b. Adding the following new AD:

     2022-19-02 Airbus SAS: Amendment 39-22171; Docket No. FAA-2022-
0682; Project Identifier MCAI-2021-01271-T.

(a) Effective Date

    This airworthiness directive (AD) is effective December 22,
2022.

(b) Affected ADs

    (1) This AD replaces the ADs identified in paragraphs (b)(1)(i)
through (iv) of this AD.
    (i) AD 2016-10-08, Amendment 39-18519 (81 FR 31844, May 20,
2016) (AD 2016-10-08).
    (ii) AD 2017-05-10, Amendment 39-18821 (82 FR 13379, March 13,
2017) (AD 2017-05-10).
    (iii) AD 2019-01-05, Amendment 39-19544 (84 FR 4310, February
15, 2019) (AD 2019-01-05).
    (iv) AD 2019-20-13, Amendment 39-19766 (84 FR 56378, October 22,
2019) (AD 2019-20-13).
    (2) This AD affects the ADs identified in paragraphs (b)(2)(i)
and (ii) of this AD.
    (i) AD 2014-16-22, Amendment 39-17946 (79 FR 49442, August 21,
2014) (AD 2014-16-22).
    (ii) AD 2017-25-13, Amendment 39-19127 (82 FR 59960, December
18, 2017) (AD 2017-25-13).

(c) Applicability

    This AD applies to Airbus SAS airplanes specified in paragraphs
(c)(1) through (5) of this AD, certificated in any category, with an
original airworthiness certificate or original export certificate of
airworthiness issued on or before July 1, 2021.
    (1) Model A330-201, -202, -203, -223, and -243 airplanes.
    (2) Model A330-223F and -243F airplanes.
    (3) Model A330-301, -302, -303, -321, -322, -323, -341, -342,
and -343 airplanes.
    (4) Model A330-841 airplanes.
    (5) Model A330-941 airplanes.

(d) Subject

    Air Transport Association (ATA) of America Code 05, Time Limits/
Maintenance Checks.

(e) Unsafe Condition

    This AD was prompted by a determination that new or more
restrictive airworthiness limitations are necessary. The FAA is
issuing this AD to address the failure of system components, which
could reduce the controllability of the airplane.

(f) Compliance

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

(g) Retained Inspection To Determine Trimmable Horizontal Stabilizer
Actuator (THSA) Part Number and Accumulated Total Flight Cycles, With
Removed References to Certain Models

    This paragraph restates the requirements of paragraph (g) of AD
2016-10-08, with removed references to certain models. For Model
A330-200 Freighter, A330-200, and A330-300 series airplanes: Within
90 days after June 24, 2016 (the effective date of AD 2016-10-08),
inspect the THSA to determine if it has part number 47147-500,
47147-700, 47172-300, 47172-500, 47172-510, or 47172-520, and to
determine the total number of flight cycles accumulated since the
THSA's first installation on an airplane, or since the most recent
no-back brake (NBB) replacement. A review of airplane delivery or
maintenance records is acceptable in lieu of this inspection if the
part number of the THSA can be conclusively determined from that
review. Accomplishing the revision of the existing maintenance or
inspection program required by paragraph (o) of this AD terminates
the requirements of this paragraph.

(h) Retained THSA Replacement for Model A330-200 Freighter, A330-200,
and A330-300 Series Airplanes, With Removed References to Certain
Models and Service Information

    This paragraph restates the requirements of paragraph (h) of AD
2016-10-08, with removed references to certain models and service
information. For Model A330-200 Freighter, A330-200, and A330-300
series airplanes having a THSA with a part number specified in
paragraph (g) of this AD: At the applicable time specified in
paragraph (h)(1), (2), or (3) of this AD, replace each affected THSA
with a serviceable THSA, in accordance with the Accomplishment
Instructions of Airbus Service Bulletin A330-27-3199, dated July 15,
2014. Accomplishing the revision of the existing maintenance or
inspection program required by paragraph (o) of this AD terminates
the requirements of this paragraph.
    (1) For a THSA that has accumulated or exceeded 20,000 total
flight cycles since the THSA's first installation on an airplane, or
since the most recent NBB replacement, whichever is later, as of
June 24, 2016 (the effective date of AD 2016-10-08): Within 6 months
after June 24, 2016.
    (2) For a THSA that has accumulated or exceeded 16,000 total
flight cycles, but less than 20,000 total flight cycles since the
THSA's first installation on an airplane, or since the most recent
NBB replacement, whichever is later, as of June 24, 2016 (the
effective date of AD 2016-10-08): Within 12 months after June 24,
2016, but without exceeding 20,000 total flight cycles.
    (3) For a THSA that has accumulated less than 16,000 total
flight cycles since first installation on an airplane, or since the
most recent NBB replacement, whichever is later, as of June 24, 2016
(the effective date of AD 2016-10-08): At the applicable time
specified in paragraph (i) of this AD.
    Note 1 to paragraph (h): This note applies to paragraphs (h) and
(i) of this AD. The THSA life limits specified in Part 4-Aging
System Maintenance of the Airbus A330 Airworthiness Limitations
Sections are still relevant, as applicable to airplane model and
THSA part number.

(i) Retained Replacement Times for Model A330-200 Freighter, A330-200,
and A330-300 Series Airplanes With THSAs Having Less Than 16,000 Total
Flight Cycles as of the Effective Date of This AD, With Removed
References to Certain Models and Service Information

    This paragraph restates the requirements of paragraph (i) of AD
2016-10-08, with removed references to certain models and service
information. The requirements of this paragraph apply to Model A330-
200 Freighter, A330-200, and A330-300 series airplanes having a THSA
with a part number specified in paragraph (g) of this AD that has
accumulated less than 16,000 total flight cycles since first
installation on an airplane, or since the most recent NBB
replacement, whichever is later, as of June 24, 2016 (the effective
date of AD 2016-10-08). Not later than the date specified in
paragraphs (i)(1), (2), or (3) of this AD, as applicable: For any
THSA having reached or exceeded on that date the corresponding
number of total flight cycles as specified in paragraphs (i)(1),
(2), or (3) of this AD, as applicable, replace the THSA with a
serviceable unit, in accordance with the Accomplishment Instructions
of Airbus Service Bulletin A330-27-3199, dated July 15, 2014.
Accomplishing the revision of the existing maintenance or inspection
program required by paragraph (o) of this AD terminates the
requirements of this paragraph.
    (1) As of 12 months after June 24, 2016 (the effective date of
AD 2016-10-08): The THSA flight-cycle limit (since first
installation on an airplane, or since last NBB replacement,
whichever occurs later) is 16,000 total flight cycles.
    (2) As of July 31, 2017: The THSA flight cycle limit (since
first installation on an airplane, or since last NBB replacement,
whichever occurs later) is 14,000 total flight cycles.
    (3) As of July 31, 2018: The THSA flight cycle limit (since
first installation on an airplane, or since last NBB replacement,
whichever occurs later) is 12,000 total flight cycles.

(j) Retained THSA Replacement Intervals for Model A330-200 Freighter,
A330-200, and A330-300 Series Airplanes, With Removed Service
Information

    This paragraph restates the requirements of paragraph (k) of AD
2016-10-08, with removed service information. For Model

A330-200 Freighter, A330-200, and A330-300 series airplanes with any
part installed, as required by paragraph (h) or (i) of this AD,
having a part number identified in paragraph (g) of this AD: From
the dates specified in paragraph (i) of this AD, as applicable, and
prior to exceeding the accumulated number of total flight cycles
corresponding to each time, replace each affected THSA with a
serviceable part, in accordance with the Accomplishment Instructions
of Airbus Service Bulletin A330-27-3199, dated July 15, 2014.
Accomplishing the revision of the existing maintenance or inspection
program required by paragraph (o) of this AD terminates the
requirements of this paragraph.

(k) Retained Definition of Serviceable THSA, With Updated Paragraph
References

    This paragraph restates the requirements of paragraph (l) of AD
2016-10-08, with updated paragraph references. For the purposes of
paragraphs (g) through (j) and (l) of this AD, a serviceable THSA is
a THSA:
    (1) Having a part number identified in paragraph (g) of this AD
that has not exceeded any of the total accumulated flight cycles
identified in paragraphs (i)(1) through (3) of this AD; or
    (2) Having a part number that is not identified in paragraph (g)
of this AD.

(l) Retained Parts Installation Limitation, With Updated Paragraph
References

    This paragraph restates the requirements of paragraph (m) of AD
2016-10-08, with updated paragraph references. For Model A330-200
Freighter, A330-200, and A330-300 series airplanes: From each date
specified in paragraphs (i)(1) through (3) of this AD, a THSA having
a part number identified in paragraph (g) of this AD may be
installed on any airplane, provided the THSA has not exceeded the
corresponding number of accumulated total flight cycles.
Accomplishing the revision of the existing maintenance or inspection
program required by paragraph (o) of this AD terminates the
requirements of this paragraph.

(m) Retained Revision of the Existing Maintenance or Inspection
Program, With No Changes

    This paragraph restates the requirements of paragraph (g) of AD
2019-20-13, with no changes. For Model A330-200 Freighter, A330-200,
and A330-300 series airplanes with an original airworthiness
certificate or original export certificate of airworthiness issued
on or before October 15, 2018: Within 90 days after November 26,
2019 (the effective date of AD 2019-20-13), revise the existing
maintenance or inspection program, as applicable, to incorporate the
information specified in Airbus A330 Airworthiness Limitations
Section (ALS) Part 4, System Equipment Maintenance Requirements
(SEMR), Revision 07, dated October 15, 2018. The component life
limits and the initial compliance time for doing the tasks are at
the times specified in Airbus A330 Airworthiness Limitations Section
(ALS) Part 4, System Equipment Maintenance Requirements (SEMR),
Revision 07, dated October 15, 2018, or within 90 days after
November 26, 2019, whichever occurs later. Accomplishing the
revision of the existing maintenance or inspection program required
by paragraph (o) of this AD terminates the requirements of this
paragraph.

(n) Retained Restrictions on Alternative Actions and Intervals, With a
New Exception

    This paragraph restates the requirements of paragraph (h) of AD
2019-20-13, with a new exception. Except as required by paragraph
(o) of this AD, after the existing maintenance or inspection program
has been revised as required by paragraph (m) of this AD, no
alternative actions (e.g., inspections) or intervals may be used
unless the actions and intervals are approved as an alternative
method of compliance (AMOC) in accordance with the procedures
specified in paragraph (s)(1) of this AD.

(o) New Revision of the Existing Maintenance or Inspection Program

    Except as specified in paragraph (p) of this AD: Comply with all
required actions and compliance times specified in, and in
accordance with, EASA AD 2021-0250, dated November 17, 2021 (EASA AD
2021-0250). Accomplishing the revision of the existing maintenance
or inspection program required by this paragraph terminates the
requirements of paragraphs (g) through (j), (l), and (m) of this AD.

(p) Exceptions to EASA AD 2021-0250

    (1) Where EASA AD 2021-0250 refers to its effective date, this
AD requires using the effective date of this AD.
    (2) The requirements specified in paragraphs (1) and (2) of EASA
AD 2021-0250 do not apply to this AD.
    (3) Paragraph (3) of EASA AD 2021-0250 specifies to ``revise the
AMP'' within 12 months after its effective date, but this AD
requires revising the existing maintenance or inspection program, as
applicable, within 90 days after the effective date of this AD.
    (4) The initial compliance time for doing the tasks specified in
paragraph (3) of EASA 2021-0250 is at the applicable ``limitations
and associated thresholds'' as incorporated by the requirements of
paragraph (3) of EASA AD 2021-0250, or within 90 days after the
effective date of this AD, whichever occurs later.
    (5) The provisions specified in paragraphs (4) and (5) of EASA
AD 2021-0250 do not apply to this AD.
    (6) The ``Remarks'' section of EASA AD 2021-0250 does not apply
to this AD.

(q) New Provisions for Alternative Actions and Intervals

    After the existing maintenance or inspection program has been
revised as required by paragraph (o) of this AD, no alternative
actions (e.g., inspections) and intervals are allowed unless they
are approved as specified in the provisions of the ``Ref.
Publications'' section of EASA AD 2021-0250.

(r) Terminating Action for AD 2014-16-22 and AD 2017-25-13

    (1) Accomplishing the action required by task number 213100-
00001-1-E of Airbus A330 Airworthiness Limitations Section (ALS)
Part 4, System Equipment Maintenance Requirements (SEMR), Revision
07, dated October 15, 2018, or using ``The ALS'' as specified in
EASA AD 2021-0250, within the compliance time specified for that
task terminates all requirements of AD 2014-16-22 for Airbus SAS
Model A330-200, -200 Freighter, and -300 series airplanes only.
    (2) Accomplishing the action required by task number 274400-
000041-E of Airbus A330 Airworthiness Limitations Section (ALS) Part
4, System Equipment Maintenance Requirements (SEMR), Revision 07,
dated October 15, 2018, or using ``The ALS'' as specified in EASA AD
2021-0250, within the compliance time specified for that task
terminates all requirements of AD 2017-25-13 for Airbus SAS Model
A330-200, -200 Freighter, and -300 series airplanes only.

(s) Additional AD Provisions

    The following provisions also apply to this AD:
    (1) 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 responsible Flight Standards Office, as
appropriate. If sending information directly to the International
Validation Branch, send it to the attention of the person identified
in paragraph (t) of this AD. Information may be emailed to: [email protected]. Before using any approved AMOC, notify your
appropriate principal inspector, or lacking a principal inspector,
the manager of the responsible Flight Standards Office.
    (2) Contacting the Manufacturer: For any requirement in this AD
to obtain instructions from a manufacturer, the instructions must be
accomplished using a method approved by the Manager, International
Validation Branch, FAA; or EASA; or Airbus SAS's EASA Design
Organization Approval (DOA). If approved by the DOA, the approval
must include the DOA-authorized signature.
    (3) Required for Compliance (RC): Except as required by
paragraph (s)(2) of this AD, if any service information contains
procedures or tests that are identified as RC, those procedures and
tests must be done to comply with this AD; any procedures or tests
that are not identified as RC are recommended. Those procedures and
tests that are not identified as RC may be deviated from using
accepted methods in accordance with the operator's maintenance or
inspection program without obtaining approval of an AMOC, provided
the procedures and tests identified as RC can be done and the
airplane can be put back in an airworthy condition. Any
substitutions or changes to procedures or tests identified as RC
require approval of an AMOC.

(t) Additional Information

    For more information about this AD, contact Vladimir Ulyanov,
Aerospace Engineer, Large Aircraft Section, FAA, International
Validation Branch, 2200 South 216th St., Des Moines, WA 98198;
telephone<PHONE_NUMBER>; email [email protected].

(u) Material Incorporated by Reference

    (1) The Director of the Federal Register approved the
incorporation by reference (IBR) of the service information listed
in this paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.
    (2) You must use this service information as applicable to do
the actions required by this AD, unless this AD specifies otherwise.
    (3) The following service information was approved for IBR on
December 22, 2022.
    (i) European Union Aviation Safety Agency (EASA) AD 2021-0250,
dated November 17, 2021.
    (ii) [Reserved]
    (4) The following service information was approved for IBR on
June 24, 2016 (81 FR 31844, May 20, 2016).
    (i) Airbus Service Bulletin A330-27-3199, dated July 15, 2014.
    (ii) [Reserved]
    (5) The following service information was approved for IBR on
November 26, 2019 (84 FR 56378, October 22, 2019).
    (i) Airbus A330 Airworthiness Limitations Section (ALS) Part 4,
System Equipment Maintenance Requirements (SEMR), Revision 07, dated
October 15, 2018.
    (ii) [Reserved]
    (6) For EASA AD 2021-0250, contact EASA, Konrad-Adenauer-Ufer 3,
50668 Cologne, Germany; telephone +49 221 8999 000; email
[email protected]; internet easa.europa.eu. You may find this EASA
AD on the EASA website at ad.easa.europa.eu.
    (7) For Airbus SAS service information, contact Airbus SAS,
Airworthiness Office--EIAS, Rond-Point Emile Dewoitine No: 2, 31700
Blagnac Cedex, France; telephone +33 5 61 93 36 96; fax +33 5 61 93
44 51; email airbus.com">[email protected]airbus.com; internet airbus.com.
    (8) You may view this material at the FAA, Airworthiness
Products Section, Operational Safety Branch, 2200 South 216th St.,
Des Moines, WA. For information on the availability of this material
at the FAA, call<PHONE_NUMBER>.
    (9) You may view this material that is incorporated by reference
at the National Archives and Records Administration (NARA). For
information on the availability of this material at NARA, email
[email protected], or go to: www.archives.gov/federal-register/cfr/ibr-locations.html.

    Issued on September 2, 2022.
Christina Underwood,
Acting Director, Compliance & Airworthiness Division, Aircraft
Certification Service.

    Editorial Note:  This document was received for publication by
the Office of the Federal Register on November 10, 2022.

[FR Doc. 2022-24991 Filed 11-16-22; 8:45 am]
BILLING CODE 4910-13-P