[Federal Register Volume 82, Number 115 (Friday, June 16, 2017)]
[Rules and Regulations]
[Pages 27618-27620]
[FR Doc No: 2017-12493]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket Number USCG-2017-0241]
RIN 1625-AA00

Safety Zone; Boston Harbor, Boston, MA

AGENCY: Coast Guard, DHS.

ACTION: Temporary final rule.

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SUMMARY: The Coast Guard is establishing a temporary safety zone for
navigable waters within a 300-yard radius of the fireworks barge
positioned in vicinity of the western side of Spectacle Island in
Boston Harbor. The safety zone is needed to protect personnel, vessels,
and the marine environment from potential hazards created by a barge
based fireworks display. Entry of vessels or persons into this zone is
prohibited unless specifically authorized by the Captain of the Port
(COTP) Boston.

DATES: This rule is effective from 8 p.m. through 10:30 p.m. on June
16, 2017.

ADDRESSES: To view documents mentioned in this preamble as being
available in the docket, go to http://www.regulations.gov, type USCG-
2017-0241 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 Mark Cutter, Waterways Management Division, U.S. Coast
Guard Sector Boston, telephone<PHONE_NUMBER>, email Mark.E.Cutter.mil.

SUPPLEMENTARY INFORMATION:

I. Table of Abbreviations

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

II. Background Information and Regulatory History

    The Coast Guard is issuing this temporary rule without prior notice
and opportunity to comment pursuant to authority under section 4(a) of
the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This
provision authorizes an agency to issue a rule without prior notice and
opportunity to comment when the agency for good cause finds that those
procedures are ``impracticable, unnecessary, or contrary to the public
interest.'' Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good
cause exists for not publishing a NPRM with respect to this rule
because doing so would be impracticable and contrary to the public
interest. The late finalization of event details from the sponsor did
not give the Coast Guard enough time to publish an NPRM, take public
comments, and issue a final rule before the event is set to begin. It
would be impracticable and contrary to the public interest to delay
promulgating this rule as it is necessary to protect the safety of the
public and waterway users.
    Under 5 U.S.C. 553(d)(3), and for the same reason stated in the
preceding paragraph, the Coast Guard finds that good cause exists for
making this rule effective less than 30 days after publication in the
Federal Register.

III. Legal Authority and Need for Rule

    The Coast Guard is issuing this rule under authority in 33 U.S.C.
1231. COTP Boston has determined that potential hazards associated with
the event on June 16, 2017 will be a safety concern for personnel,
vessels, and the marine environment from potential hazards created by a
barge based fireworks display. The purpose of this rule is to ensure
safety of the marine environment and navigable waters in the safety
zone before, during, and after the scheduled event.

IV. Discussion of the Rule

    This rule establishes a safety zone from 8 p.m. through 10:30 p.m.
on June 16, 2017. The safety zone will cover all navigable waters
within specific geographic locations specified in the regulatory text
on the navigable waters of Boston Harbor, Boston, Massachusetts.
Vessels not associated with the fireworks display shall maintain a
distance of at least 300 yards from the fireworks barge. The duration
of the zone is intended to ensure the safety of maritime public before,
during, and after the event scheduled from 8 p.m. through 10:30 p.m. No
vessel or person would be permitted to enter the safety zone without
obtaining permission from the COTP or a designated representative.

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. This rule has not been designated
a ``significant regulatory action,'' under Executive Order 12866.
Accordingly, it has not been reviewed by the Office of Management and
Budget.
    We expect the economic impact of this rule to be minimal. This
regulation may have some impact on the public, but that potential
impact will likely be minimal for several reasons. First, this safety
zone will be in effect for less than three hours. Second, vessels may
enter or pass through the safety zone during an enforcement period with
the permission of the COTP or the designated representative. Finally,
the Coast Guard will provide notification to the public through Local
Notice to Mariners and Broadcast Notice to Mariners well in advance of
the event.

B. Impact on Small Entities

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

C. Collection of Information

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

D. Federalism and Indian Tribal Governments

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

E. Unfunded Mandates Reform Act

    The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538)
requires Federal agencies to assess the effects of their discretionary
regulatory actions. In particular, the Act addresses actions that may
result in the expenditure by a State, local, or tribal government, in
the aggregate, or by the private sector of $100,000,000 (adjusted for
inflation) or more in any one year. Though this rule will not result in
such 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 a safety zone lasting less than three hours that will
prohibit entry into a 300 yards zone around the fireworks. It is
categorically excluded from further review under paragraph 34(g) of
Figure 2-1 of the Commandant Instruction. An Record of Environmental
Consideration (REC) is 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.T01-0241 to read as follows:

Sec.  165.T01-0241  Safety Zone--Boston Harbor Now--Boston Harbor,
Boston, Massachusetts.

    (a) General. Establish a temporary safety zone:
    (1) Location. The following area is a safety zone: All navigable
waters within

300-yard radius of the fireworks barge positioned in vicinity of
42[deg]19'14'' N., 070[deg]59'36'' before, during, and after the
fireworks display.
    (2) Effective and enforcement period. This rule will be effective
on June 16, 2017, from 8 p.m. through 10:30 p.m.
    (b) Regulations. While this safety zone is being enforced, the
following regulations, along with those contained in 33 CFR 165.23
apply:
    (1) No person or vessel may enter or remain in this safety zone
without the permission of the Captain of the Port (COTP) or the COTP's
representatives. However, any vessel that is granted permission by the
COTP or the COTP's representatives must proceed through the area with
caution and operate at a speed no faster than that speed necessary to
maintain a safe course, unless otherwise required by the Navigation
Rules.
    (2) Any person or vessel permitted to enter the safety zone shall
comply with the directions and orders of the COTP or the COTP's
representatives. Upon being hailed by a U.S. Coast Guard vessel by
siren, radio, flashing lights, or other means, the operator of a vessel
within the zone shall proceed as directed. Any person or vessel within
the safety zone shall exit the zone when directed by the COTP or the
COTP's representatives.
    (3) To obtain permissions required by this regulation, individuals
may reach the COTP or a COTP representative via VHF channel 16 or 617-
223-5757 (Sector Boston Command Center).
    (c) Penalties. Those who violate this section are subject to the
penalties set forth in 33 U.S.C. 1232 and 50 U.S.C. 1226.
    (d) Notification. Coast Guard Sector Boston will give notice
through the Local Notice to Mariners and Broadcast Notice to Mariners
for the purpose of enforcement of this temporary safety zone. Sector
Boston will also notify the public to the greatest extent possible of
any period in which the Coast Guard will suspend enforcement of this
safety zone.
    (e) COTP representative. The COTP's representative may be any Coast
Guard commissioned, or petty officer or any federal, state, or local
law enforcement officer who has been designated by the COTP to act on
the COTP's behalf. The COTP's representative may be on a Coast Guard
vessel, a Coast Guard Auxiliary vessel, a state or local law
enforcement vessel, or a location on shore.

    Dated: June 9, 2017.
C.C. Gelzer,
Captain, U.S. Coast Guard, Captain of the Port Boston.
[FR Doc. 2017-12493 Filed 6-15-17; 8:45 am]
 BILLING CODE 9110-04-P


[Federal Register Volume 86, Number 145 (Monday, August 2, 2021)]
[Rules and Regulations]
[Pages 41402-41404]
[FR Doc No: 2021-16197]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket Number USCG-2021-0480]
RIN 1625-AA00

Safety Zone; Lake of the Ozarks, Mile Markers 7, 10.5, 13, 16,
22, 26, 34, and 42, Lake of the Ozarks, MO

AGENCY: Coast Guard, DHS.

ACTION: Temporary final rule.

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SUMMARY: The Coast Guard is establishing temporary safety zones in all
navigable waters extending 420 feet in all directions around fireworks
barges at eight different locations on the Lake of the Ozarks. These
safety zones are needed to protect personnel, vessels, and the marine
environment from potential hazards created by the fireworks displays.
Entry of vessels or persons into these zones is prohibited unless
specifically authorized by the Captain of the Port Sector Upper
Mississippi River or a designated representative.

DATES: This rule is effective on August 10, 2021 at 10 p.m. to 10:30
p.m.

ADDRESSES: To view documents mentioned in this preamble as being
available in the docket, go to https://www.regulations.gov, type USCG-
2021-0480 in the search box and click ``Search.'' Next, in the Document
Type column, select ``Supporting & Related Material.''

FOR FURTHER INFORMATION CONTACT: If you have questions on this rule,
call or email Lieutenant Commander Stephanie Moore, Sector Upper
Mississippi River Waterways Management Division, 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
Sec.  Section
U.S.C. United States Code

II. Background Information and Regulatory History

    The Coast Guard is issuing this temporary rule without prior notice
and opportunity to comment pursuant to authority under section 4(a) of
the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This
provision authorizes an agency to issue a rule without prior notice and
opportunity to comment when the agency for good cause finds that those
procedures are ``impracticable, unnecessary, or contrary to the public
interest.'' Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good
cause exists for not publishing a notice of proposed rulemaking (NPRM)
with respect to this rule because it is impracticable. We must
establish this safety zone by August 10, 2021 and lack sufficient time
to provide a reasonable comment period and then consider those comments
before issuing the rule.
    Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause
exists for making this rule effective less than 30 days after
publication in the Federal Register. Delaying the effective date of
this rule would be contrary to the public interest because immediate
action is needed to respond to the potential safety hazards associated
with the fireworks displays on August 10, 2021.

III. Legal Authority and Need for Rule

    The Coast Guard is issuing this rule under authority in 46 U.S.C.
70034 (previously 33 U.S.C. 1231). The Captain of the Port Sector Upper
Mississippi River (COTP) has determined that potential hazards
associated with the fireworks displays on August 10, 2021 will be a
safety concern for anyone on the Lake of the Ozarks at the designated
launch locations. This rule resulted from a marine event notification
stating that there will be fireworks displays to celebrate a
bicentinneal birthday on the Lake of the Ozarks. This rule is needed to
protect personnel, vessels, and the marine environment in the navigable
waters within the safety zone before, during, and after the fireworks
display.

IV. Discussion of the Rule

    This rule establishes safety zones on August 10, 2021 from 10 p.m.
until 10:30 p.m. The safety zones will be located on all navigable
waters extending 420 feet in all directions around fireworks barges at
the following locations on the Lake of the Ozarks at (1) mile marker 7
(38 12'35.20'' N 92 45'02.57'' W), (2) mile marker 10.5 (38 01'21.93''
N 92 47'38.93'' W), (3) mile marker 13 (38 11'01.86'' N 92 41'19.32''
W), (4) mile marker 16 (38 08'54.89'' N 92 38'29.53'' W), (5) mile
marker 22 (38 08'54.89'' N 92 41'18.95'' W), (6) mile marker 26 (38
07'25.22'' N 92 42'58.65'' W), (7) mile marker 34 (38 07'25.22'' N 92
47'34.59'' W) and (8) mile marker 42 (38 08'55'' N 92 52'23.30'' W).
The duration of these zones is intended to protect personnel, vessels,
and the marine environment in these navigable waters before, during,
and after the fireworks displays. No vessel or person will be permitted
to enter the safety zones without obtaining permission from the COTP or
a designated representative. A designated representative is a
commissioned, warrant, or petty officer of the U.S. Coast Guard
assigned to units under the operational control of USCG Sector Upper
Mississippi River. The COTP or a designated representative will inform
the public of the enforcement date and times for these safety zones, as
well as any emergent safety concerns that may delay the enforcement of
the zones.

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. 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).
    This regulatory action determination is based on size, location,
and duration of the temporary safety zones. This action involves
fireworks displays at multiple designated locations on the

Lake of the Ozarks accuring symultaniously on August 10, 2021 and
lasting 30 minutes. Vessels will be able to transit around the safety
zones. Moreover, the Coast Guard will publish a Local Notice to
Mariners and mariners may seek permission to enter the zones.

B. Impact on Small Entities

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

C. Collection of Information

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

D. Federalism and Indian Tribal Governments

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

E. Unfunded Mandates Reform Act

    The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538)
requires Federal agencies to assess the effects of their discretionary
regulatory actions. In particular, the Act addresses actions that may
result in the expenditure by a State, local, or tribal government, in
the aggregate, or by the private sector of $100,000,000 (adjusted for
inflation) or more in any one year. Though this rule will not result in
such 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
Directive 023-01, Rev. 1, associated implementing instructions, and
Environmental Planning COMDTINST 5090.1 (series), 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 safety
zones lasting thirty minutes that will prohibit entry on the Lake of
the Ozarks at (1) mile marker 7 (38 12'35.20'' N 92 45'02.57'' W), (2)
mile marker 10.5 (38 01'21.93'' N 92 47'38.93'' W), (3) mile marker 13
(38 11'01.86'' N 92 41'19.32'' W), (4) mile marker 16 (38 08'54.89'' N
92 38'29.53'' W), (5) mile marker 22 (38 08'54.89'' N 92 41'18.95'' W),
(6) mile marker 26 (38 07'25.22'' N 92 42'58.65'' W), (7) mile marker
34 (38 07'25.22'' N 92 47'34.59'' W) and (8) mile marker 42 (38 08'55''
N 92 52'23.30'' W). It is categorically excluded from further review
under paragraph L60 of Appendix A, Table 1 of DHS Instruction Manual
023-01-001-01, Rev. 1. It is categorically excluded from further review
under paragraph L60, Table 1 of DHS Instruction Manual 023-01-001-01,
Rev. A Record of Environmental Consideration supporting this
determination is available in the docket. For instructions on locating
the docket, see the ADDRESSES section of this preamble.

G. Protest Activities

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

List of Subjects in 33 CFR Part 165

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

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

PART 165--REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS

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

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

0
2. Add Sec.  165.T08-0707 to read as follows:

Sec.  165.T08-0707  Safety Zones; Lake of the Ozarks, Mile Markers 7,
10.5, 13, 16, 22, 26, 34, 42, Lake of the Ozarks, MO

    (a) Location. All navigable waters extending 420 feet in all
directions around fireworks barges at the following locations on the
Lake of the Ozarks at:
    (1) Mile marker 7 (38 12'35.20'' N 92 45'02.57'' W);
    (2) Mile marker 10.5 (38 01'21.93'' N 92 47'38.93'' W);
    (3) Mile marker 13 (38 11'01.86'' N 92 41'19.32'' W);
    (4) Mile marker 16 (38 08'54.89'' N 92 38'29.53'' W);
    (5) Mile marker 22 (38 08'54.89'' N 92 41'18.95'' W);
    (6) Mile marker 26 (38 07'25.22'' N 92 42'58.65'' W;
    (7) Mile marker 34 (38 07'25.22'' N 92 47'34.59'' W); and

    (8) Mile marker 42 (38 08'55'' N 92 52'23.30'' W).
    (b) Period of enforcement. August 10, 2021 from 10 p.m. until 10:30
p.m.
    (c) Regulations. (1) In accordance with the general regulations in
Sec.  165.23 of this part, persons and vessels are prohibited from
entering the safety zone unless authorized by the Captain of the Port
Sector Upper Mississippi River (COTP) or a designated representative. A
designated representative is a commissioned, warrant, or petty officer
of the U.S. Coast Guard assigned to units under the operational control
of USCG Sector Upper Mississippi River.
    (2) Persons or vessels desiring to enter into or pass through the
zone must request permission from the COTP or a designated
representative. They may be contacted on VHF radio Channel 16 or by
telephone at<PHONE_NUMBER>.
    (3) If permission is granted, all persons and vessels shall comply
with the instructions of the COTP or designated representative while
navigating in the regulated area.
    (d) Informational broadcasts. The COTP or a designated
representative will inform the public of the enforcement date and times
for this safety zone, as well as any emergent safety concerns that may
delay the enforcement of the zone through either A Safety Marine
Information Broadcast (SMIB), Broadcast Notice to Mariners (BNM) and or
Local Notices to Mariners (LNMs).

R.M. Scott,
Captain, U.S. Coast Guard, Captain of the Port Sector Upper Mississippi
River.
[FR Doc. 2021-16197 Filed 7-30-21; 8:45 am]
BILLING CODE 9110-04-P


Control Area For Giant Reed (Cane) Grass Arundo donax in Oregon

603-052-1207

Definitions

As used in OAR<PHONE_NUMBER> to<PHONE_NUMBER> unless the context requires
otherwise:

 “Giant reed” or “giant cane grass” means the plant species
Arundo donax L.  For purposes of this rule the term “giant reed” or
“giant cane grass” applies to whole plants, plant parts, rhizomes,
and seeds.  For purposes of this rule, “giant reed” or “gaint cane
grass” does not include variegated varieties of giant reed as defined
in subsection (4) of this section.

“Feral” gaint reed means whole plants of the plant species Arundo
donax growing outside of permitted production areas or as otherwise
inconsistent with this rule.

 “Special Flood Hazard Area” means an area inundated during the 1%
annual flood (also known as 100-year flood) as determined from the
January 2011 version of the Flood Insurance Rate Maps of the Federal
Emergency Management Agency (FEMA) available through the Department of
Land Conservation and Development at <oregonriskmap.com>.

 “Variegated varieties of giant reed” means horticultural varieties
of Arundo donax with striped or spotted leaves.  Variegated varieties
may include but are not limited to varieties marketed as “Peppermint
Stick”, “Variegata,” and “Golden Chain,” or other ornamental
varieties that can be visually distinguished from “gaint reed” or
“giant cane grass.”

“Water body” includes lakes, bays, ponds, impounding reservoirs,
springs, rivers, streams, creeks, estuaries, marshes, wetlands as
defined in ORS 196.800(16), inlets, canals, irrigation ditches, drainage
ditches, and all other bodies of surface waters, natural or artificial,
inland or coastal, fresh or salt, public or private, which are wholly or
partially within or bordering the state or within its jurisdiction.

603-052-1209

Purpose

Giant reed, Arundo donax, is a promising bio-energy crop because of its
high biomass yield.  It is also grown as an ornamental and as a source
of reeds for woodwind instruments.  Giant reed is highly invasive in
riparian areas in some regions of the United States such as California,
Texas, and Florida.  It is the intent and purpose of OAR<PHONE_NUMBER> to
603-052-1212 to balance goals to develop new agricultural crops and
support renewable energy development from agricultural feedstocks while
protecting natural resources and preventing the establishment of giant
reed in riparian areas where it could cause major negative impacts to
the natural resources of the State of Oregon.

603-052-1212

Control Area

As authorized by ORS 570.405, a statewide control area is established to
reduce the risk of uncontrolled spread of giant reed into the
environment in order to protect the horticultural, agricultural or
forest industries of the state.

Extent of Control Area: All of the State of Oregon.

Commodities Covered: All life stages of giant reed, Arundo donax.

Prohibited Acts

Giant reed is prohibited from being imported, planted, propagated, or
grown except as allowed in this rule in sections (5) through (7) below.

Giant reed shall not be planted or grown near water bodies as defined in
OAR<PHONE_NUMBER>(4).  Where giant cane is invasive, primary dispersal is
by movement of rhizome and stem fragments in floods.  To prevent flood
dispersal, giant reed must not be planted or grown within the special
flood hazard area (100-year flood) of any water body as “special flood
hazard area” is defined in OAR<PHONE_NUMBER>(3).  There are no fixed
setback from bodies of water where the planting or growing of giant
reeed is prohibited as flood hazard areas vary in width and shape
depending on terrain and other factors.  The prohibition in this
subsection applies consistently with the definition of “special flood
hazard area” as this may be determined from the January 2011 FEMA risk
map.

Permit Requirements

Except as specified in OAR<PHONE_NUMBER>(7)(b), giant reed shall not be
planted or grown in Oregon without a permit from the Oregon Department
of Agriculture (ODA).

Applications for a permit must be in writing to ODA and include specific
locations and detailed maps of the field locations and any water bodies
in the vicinity of all proposed field locations. Applications for a
permit to produce giant reed must be sent to: Plant Program Area
Director, Oregon Department of Agriculture, 635 Capitol St. NE, Salem,
OR 97304 or emailed to<EMAIL_ADDRESS>
ODA will review the application upon its receipt and share the
application information with noxious weed control officials in the
county(ies) were production of giant reed is grown or proposed to be
grown.

ODA may deny an application or may issue a permit with any conditions as
may be necessary to prevent the uncontrolled spread of giant reed or as
necessary to protect the horticultural, agricultural or forest
industries of the state.  Conditions that ODA may require include but
are not limited to conditions requiring notification to ODA of the dates
when giant reed fields are planted and are taken out of production,
annual updates on field locations, or any other precautions related to
site-specific risk factors presented by a proposed growing location.

Any equipment used in giant reed production fields must be cleaned free
of soil and plant debris prior to leaving production fields.

Planting stock from outside of Oregon is prohibited unless it is
produced via tissue culture (in vitro).  In-state producers of biofuel
planting stock are subject to the same requirements as biofuel
producers.

Conditioning (crushing) and drying harvested giant reed plant material
in the field to reduce cane viability and baling of the material before
transport in covered containers is required.

ODA may enter into a contract with any person seeking to plant or
produce giant reed pursuant to a permit issued by ODA.  Any contract may
require a permit holder to pay an annual assessment of $2.00 per acre to
ODA for the cost of monitoring fields where giant reed is produced under
a permit and for surveys of riparian areas in the vicinity of permitted
production fields.  Monitoring and surveys are necessary to ensure that
giant reed has not escaped outside of permitted production areas and is
necessary for enforcing the terms of the control area established in
this rule.

(6) Bond; Conditions for Ceasing Production of Giant Reed

Any holder of a permit for the production of giant reed for other than
ornamental or woodwind reed purposes (see (8) below) must post a bond or
another form of acceptable collateral of $100/acre up to a maximum of
$1,000,000 with the Dapartment of Agriculture.  The purpose of the bond
is to cover any and all costs associated with the detection and
eradication of giant reed inside or outside of production fields if the
Department determines feral giant reed must be eradicated in order to
protect the agricultureal, horticultural or forest resources of the
State.  The bond must be in place for the duration of permitted
production and remain effective for 2 years afer permitted produciton
ceases.

The holder of a permit for the production of giant reed that ceases
production of giant reed, must completely eradicate giant reed in a
manner that prevents unmanaged fields from becoming a source of
propagules that could lead to accidental spread of giant reed in the
wild.

Any holder of a permit issued by ODA must monitor any and all areas upon
which giant reed was produced under a permit for at least two years
after production ceases to ensure that all giant reed plants are killed
and any source of propagules are eradicated.  ODA may require additional
monitoring time as it determines is necessary to assure complete
eradication of giant reed from areas permitted for production.

Any and all costs associated with eradicaiton of giant reed in
production fields and adjacent property owned or controlled by the
producer after production has ceased is the responsibility of the permit
holder.

Oregon State University Research and Extension Certers are exempt from
sections (5)(h) and (6)(a) of this rule for the purpose of allowing
research related to giant reed production and control.

 (7) Conditions for Ornamental and Woodwind Reed Plantings

Giant reed has been used as an ornamental plant in Oregon for many
years.  It is also grown as a source for woodwind reeds. Ornamental or
woodwind reed plantings could result in feral populations.  In order to
lower the risk of ornamental or woodwind reed plants becoming feral,
giant reed is being phased out of the nursery trade.  Variegated
varieties such as “Peppermint Stick,” “Variegata,” and “Golden
Chain,” may continue to be grown and sold in Oregon unless ODA and
State Weed Board list giant reed as a noxious weed.  Variegated
varieties are less hardy and less likely to become invasive.

After December 31, 2013, only variegated varities of giant reed may be
sold in Oregon for ornamental or woodwind reed purposes.

A permit is not required for ornamental or woodwind reed plantings of
variegated varieties of giant reed totaling less than ¼ acre.

Ornamental and woodwind reed plantings of giant reed existing before
these rules were adopted will not be considered feral unless they are in
Special Flood Hazard Areas or the ODA determines such populations are
becoming invasive.  Any plantings of giant reed or variegated varieties
of giant reed over ¼ acres are subject to the permitting requirements
in OAR<PHONE_NUMBER>(5).

If the ODA and the State Weed Board determine giant reed is a noxious
weed, all ornamental and non-permited uses of giant reed shall
terminate.

(8) Eradication and Control of Giant Reed

Except as stated in (7) above, ODA considers giant reed plants detected
outside of permitted production fields as feral plants which shall be
eradicated or controlled.

Any person owning or occupying property upon which feral giant reed is
detected must contact the ODA within 48 hours of detection.

Upon detection of feral giant reed, ODA may develop a survey,
eradication, and monitoring plan to control or eradicate detected feral
giant reed.  Consistent with its authorities, ODA may develop and
conduct appropriate measures to control or eradicate feral giant reed,
may enter into a contract for the purpose of controlling or eradicating
feral giant reed, or take any measures necessary to control or eradicate
feral giant reed consistent with law.

Control or eradication of feral giant reed may be implemented at no cost
to a person owning or controlling land within this state upon which
feral giant reed is detected.  However, ODA may request any person
owning or controlling land within this state to control, prevent the
spread of, or eradicate feral giant reed, subject to supervision of such
activities by ODA.

If ODA is unable to control or eradicate feral giant reed on private
property, then consistent with the provision of ORS 570.405(2), any
person owning or controlling land within this state must take measures
to eliminate or prevent the possibility of spread of feral giant reed to
other lands and ownerships.  Control measures for feral giant reed must
be implemented in a timely manner as determined by ODA.  Treatments must
provide sufficient levels of control to make progress toward the goal of
eradication.

(9) Review

Before December 31, 2022, the Department will conduct a thorough review
of the effectivness and necessity for this rule.  If by that date giant
reed has not been declared a noxious weed by ODA and the State Weed
Board, the bond/collateral requirement (6)(a) sunsets unless
specifically extended via amendment to this rule.

[Type text]	[Type text]	[Type text]


[Federal Register Volume 84, Number 76 (Friday, April 19, 2019)]
[Notices]
[Pages 16516-16517]
[FR Doc No: 2019-07931]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-D-1261]

Technical Considerations for Non-Clinical Assessment of Medical
Devices Containing Nitinol; Draft Guidance for Industry and Food and
Drug Administration Staff; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of the draft guidance entitled ``Technical
Considerations for Non-Clinical Assessment of Medical Devices
containing Nitinol.'' Due to the unique properties of nitinol, the
Agency has developed this draft guidance to provide FDA's current
thinking on technical considerations specific to devices using nitinol.
This draft guidance document is intended to provide clarity and
consistency in recommended non-clinical assessments across a variety of
medical devices that contain nitinol. This draft guidance is not final
nor is it in effect at this time.

DATES: Submit either electronic or written comments on the draft
guidance by June 18, 2019 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final
version of the guidance.

ADDRESSES: You may submit comments on any guidance at any time as
follows:

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2019-D-1261 for ``Technical Considerations for Non-Clinical
Assessment of Medical Devices containing Nitinol.'' Received comments
will be placed in the docket and, except for those submitted as
``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).

    An electronic copy of the guidance document is available for
download from the internet. See the SUPPLEMENTARY INFORMATION section
for information on electronic access to the guidance. Submit written
requests for a single hard copy of the draft guidance document entitled
``Technical Considerations for Non-Clinical Assessment of Medical
Devices containing Nitinol'' to the Office of Policy, Guidance and
Policy Development, Center for Devices and Radiological Health, Food
and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5431,
Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to
assist that office in processing your request.

FOR FURTHER INFORMATION CONTACT: Matthew Di Prima, Center for Devices
and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 62, Rm. 2214, Silver Spring, MD 20993-0002, 301-
796-2507.

SUPPLEMENTARY INFORMATION:

I. Background

    The use of nitinol in medical devices began over 3 decades ago in
product areas such as orthodontic archwires, cardiovascular guidewires,
and surgical instruments. Its use has increased over the past 2 decades
into different device areas such as orthopedic fracture fixation,
cardiovascular stents, and transcatheter heart valves. With an
increasing trend to treat patients using minimally invasive procedures,
nitinol has become a popular choice of material due to its ability to
return to its original shape after being deformed or after heat is
applied. Given the complex thermomechanical behavior of nitinol, there
are unique considerations when assessing the safety and performance of
nitinol-containing devices.
    The Agency has developed this draft guidance to provide FDA's
current thinking on technical considerations specific to devices using
nitinol. These recommendations are intended to be general and not
product-specific, and apply to medical devices that have at least one
patient contacting component comprised of nitinol.

II. Significance of Guidance

    This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the current thinking of FDA on ``Technical
Considerations for Non-Clinical Assessment of Medical Devices
containing Nitinol''. It does not establish any rights for any person
and is not binding on FDA or the public. You can use an alternative
approach if it satisfies the requirements of the applicable statutes
and regulations. This guidance is not subject to Executive Order 12866.

III. Electronic Access

    Persons interested in obtaining a copy of the draft guidance may do
so by downloading an electronic copy from the internet. A search
capability for all Center for Devices and Radiological Health guidance
documents is available at https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. This
guidance document is also available at https://www.regulations.gov.
Persons unable to download an electronic copy of ``Technical
Considerations for Non-Clinical Assessment of Medical Devices
containing Nitinol'' may send an email request to [email protected] to receive an electronic copy of the document.
Please use the document number 17013 to identify the guidance you are
requesting.

IV. Paperwork Reduction Act of 1995

    This draft guidance refers to previously approved collections of
information. 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
the following FDA regulations and guidance have been approved by OMB as
listed in the following table:

------------------------------------------------------------------------
                                                            OMB control
    21 CFR part or guidance               Topic                 No.
------------------------------------------------------------------------
807, subpart E.................  Premarket notification.       0910-0120
814, subparts A through E......  Premarket approval.....       0910-0231
814, subpart H.................  Humanitarian Device           0910-0332
                                  Exemption.
812............................  Investigational Device        0910-0078
                                  Exemption.
``De Novo Classification         De Novo classification        0910-0844
 Process (Evaluation of           process.
 Automatic Class III
 Designation)''.
``Requests for Feedback on       Q-submissions..........       0910-0756
 Medical Device Submissions:
 The Pre-Submission Program and
 Meetings with Food and Drug
 Administration Staff``.
801............................  Medical Device Labeling       0910-0485
                                  Regulations.
------------------------------------------------------------------------

    Dated: April 16, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-07931 Filed 4-18-19; 8:45 am]
 BILLING CODE 4164-01-P


ERG Task Order 0<IP_ADDRESS>

TECHNICAL CHARGE AND INSTRUCTIONS TO PEER REVIEWERS

Peer Review of OSHA’s Preliminary Quantitative Risk Assessment Section
for Beryllium

You have been selected to participate in an external peer review of
OSHA’s preliminary risk assessment for beryllium.  The risk
assessment will be part of a proposed rule that would amend the existing
regulation for occupational exposure to beryllium.  The risk assessment
is the primary analysis upon which the Agency relies to determine
whether employees exposed to beryllium at the current permissible
exposure limit face a significant risk of material impairment to their
health and whether the proposed standard will substantially reduce that
risk.  It is not meant to include all adverse effects that result from
beryllium exposure.  This risk assessment addresses two related adverse
effects of beryllium exposure, beryllium sensitization and chronic
beryllium disease (CBD).  Other sections of the proposed rule discuss
additional health hazards, including lung cancer, and the evidence that
supports their association with beryllium.

The overriding goal of the peer review is to ensure that OSHA has based
its risk assessment on appropriate publications and data, has clearly
explained its analysis, and has interpreted or analyzed these
publications and data in a manner that is reasonable, sound, and
scientifically credible.  Keep in mind that OSHA’s responsibility is
to protect worker health and the Agency may choose conservative
assumptions where appropriate, and that OSHA is not required to support
its determination of significant risk with quantitative precision or
scientific certainty.  The Agency’s aim is to evaluate the overall
body of evidence to determine whether, based on the currently available
information, it is reasonable to conclude that there is a significant
risk to workers exposed at the current Permissible Exposure Limit (PEL)
and that the proposed PEL will substantially reduce that risk.

OSHA has provided the following questions to guide and focus your review
on issues of importance to the Agency. Your review should, at a minimum,
address each question, providing a discussion and rationale for any
“yes” or “no” responses, and providing other comprehensive
comments to clarify your comments and/or recommendations. .  After the
charge questions, you will find instructions on how to access the
reference materials on ERG’s FTP site.

Charge Questions

As the key studies for the preliminary risk assessment, OSHA selected
studies of a beryllia ceramics plant, a beryllium machining facility,
and a beryllium-copper alloy facility because they are facilities with
well-characterized, relatively low airborne beryllium levels, have used
multiple approaches to controlling beryllium exposure, and have used
plant-wide screenings for sensitization and CBD to test the
effectiveness of exposure controls.  Has OSHA clearly and adequately
explained why these were selected as the key studies for the preliminary
risk assessment?  Are there other publications that should be included
among the key studies as a basis of OSHA's risk assessment?  If so,
please identify which additional studies should be included and why they
should be considered key studies for the risk assessment.  In
particular, are there additional studies of sensitization and CBD in
facilities with primarily low (< 0.2 ug/m3) worker exposures and/or
dermal protection requirements, and that have well-documented exposures,
based on full-shift personal lapel samples or other breathing zone
measurements?

OSHA's review of the key studies concluded that the greatest reduction
in risk was achieved when workers' full-shift median exposures for all
processes were reduced to 0.1 ug/m3 or below.  OSHA also observed
substantial risk of sensitization and CBD in facilities where the
highest-exposed processes had median beryllium levels of about 0.2 ug/m3
or higher.  Was OSHA's discussion of the key studies and the logic of
its preliminary conclusions adequately described and clearly
presented?  Were OSHA's preliminary conclusions based on these studies
reasonable and scientifically credible?

Of the three key publications the Agency used to describe risk of
sensitization at very low levels of airborne beryllium exposure, one was
used to characterize risk of CBD at low levels because the other two
were too recent to have extensive follow-up time and did not report the
results of evaluations for CBD.  Are there other publications that
could provide more complete information about the risk of CBD among
workers exposed to airborne beryllium at very low concentrations?

OSHA’s risk assessment discussed three studies of community-acquired
CBD.  Based on these studies, which included estimates of airborne
beryllium exposure concentrations within the affected communities, the
Agency concluded that individuals who are exposed to airborne beryllium
at very low levels (< 0.1 ug/m3) can develop CBD.  Is OSHA's preliminary
conclusion based on these studies clearly presented and reasonable?  In
particular, is it reasonable to conclude based on these publications
that the cases of CA-CBD reported in these studies resulted from very
low-level beryllium exposure? Are there additional sources of
information on the exposure levels or occurrence of beryllium disease in
these or other affected communities the Agency should consider?

Dermal contact with beryllium has been identified in the scientific
literature   as a likely exposure route for beryllium sensitization.
Has OSHA’s discussion of sensitization risk adequately addressed the
role of dermal exposure and dermal protection?  Are there additional
studies or data on risk of dermal sensitization the Agency should
include in the preliminary risk assessment?

OSHA elected to conduct an exposure-response analysis on a dataset
provided by National Jewish Medical and Research Center, collected at a
beryllium machining facility in Cullman, AL.  Was the Agency’s
decision to base an exposure-response analysis on the Cullman, AL
dataset clearly explained and reasonable?  Are there other datasets that
would provide a better basis for exposure-response analysis?  If so,
please identify them and explain why they would provide a better basis
for exposure-response analysis.

To estimate exposures for individual workers in the Cullman, AL dataset,
OSHA’s contractor constructed a job-exposure matrix (JEM) from
industrial hygiene samples provided in the dataset, grouping the data
into time periods based on information about historical conditions at
the plant, and used this JEM in combination with detailed work histories
to estimate beryllium exposure for each worker in the dataset.  A
detailed description of the Agency’s procedure is presented in the
technical companion document, OSHA Cullman risk background.doc,
available at the ERG reference site.  Were the procedures used to group
across time periods and job operations as well as to estimate workers’
exposures adequately described and clearly presented?

OSHA elected to use cumulative exposure to the total mass of beryllium
to quantitatively estimate risk of beryllium sensitization and CBD.   Is
this exposure measure reasonable and appropriate as a basis of
exposure-response analysis for beryllium sensitization and CBD?  Is the
rationale for this choice clearly explained?  Are there other exposure
metrics that would provide a better basis for the exposure-response
analysis?  If so please explain why they would provide a better basis
for the exposure – response analysis and indicate whether there are
datasets available with which to conduct an exposure-response analysis
using these metrics.

OSHA’s contractor used a quartile analysis and statistical modeling
approaches to characterize exposure-response for sensitization and CBD.
A detailed description of the Agency’s procedure is presented in the
technical companion document, OSHA Cullman risk background.doc,
available at the ERG reference site.  Were these analyses adequately and
clearly described?  Were the statistical methods applied correctly
executed, and appropriate to the nature of the dataset and health
outcomes?  Was the derivation of quantitative risk estimates based on
these analyses clearly explained?   Are the risk estimates reasonable?

The preliminary risk assessment identifies and describes several key
areas of uncertainty with regard to the estimates of risk.  Were the
major uncertainties in the risk assessment adequately characterized?
Were key assumptions in the risk assessment stated and adequately
discussed?  If not, please explain what further discussion should be
included.

Because sensitization and CBD have been shown to occur at exposure
levels well below the current PEL in several occupational cohorts, OSHA
identified these health endpoints as the most appropriate for developing
estimates of risk. On the other hand, the exposure – response data
available for lung cancer mortality have shortcomings that make
quantitative risk assessment for this endpoint less desirable. The
Agency has therefore chosen to analyze workers’ risk of sensitization
and CBD to establish the risk findings for the proposed rule, rather
than the risk of lung cancer.  Is the rationale for this position
reasonable and clearly explained?

Accessing References

You may access all reference materials on ERG’s FTP site (see attached
instructions), which are filed in the Risk Assessment folder.  Note:
OSHA has become aware of two very recent publications in the Journal of
Occupational and Environmental Medicine that may have bearing on the
occupational risk of beryllium sensitization and chronic beryllium
disease.  One evaluated the effectiveness of an enhanced preventative
program on the prevalence and incidence rate of sensitization at a
beryllium processing plant (Bailey et al., JOEM, 52(5): 505-512, May
2010).  The authors concluded that the preventative program reduced but
did not eliminate beryllium sensitization.  The other publication
presented results from a study of beryllium sensitized workers evaluated
for CBD (Arjomandi et al., JOEM, 52(6): 647-652, June 2010).  The
workers were employed at a nuclear weapons research and development
facility.  This study showed that the worker cohort characterized by
potentially low beryllium exposures and long latency had a low
prevalence of CBD.

Unfortunately, the publications became available while the OSHA Health
Effects and Risk Assessment documents were undergoing the final stages
of internal review and OSHA was unable to incorporate these publications
into their analysis.  However, electronic copies of the articles are
being provided with the other key references for your review and
comment.

Briefing Conference Call

We will be scheduling a briefing conference call to take place in the
next few weeks during which you will have the opportunity to ask
questions of clarification on the charge and review documents.  OSHA
staff will participate to give a brief overview and background for this
peer review and to answer any questions you may have.

Questions?

Feel free to contact Kate Schalk at<PHONE_NUMBER> or Katherine Moore at
781-674-7348 with any questions or concerns.

WRITTEN COMMENTS ARE DUE TO ERG

NO LATER THAN TUESDAY, AUGUST 31, 2010

REVIEW GUIDELINES

Upon receipt of the review materials, you should have no communications
with members of the public, colleagues or co-workers, OSHA, or other
federal agencies on the materials study under review. If you are
contacted in person or in writing on the peer review by anyone other
than ERG, you should immediately inform Kate Schalk, via email at
HYPERLINK<EMAIL_ADDRESS><EMAIL_ADDRESS>, or via
phone at<PHONE_NUMBER>.

If you have any questions on the review materials or need any further
clarification, please contact ERG only and ERG will work with OSHA to
get a reply back to you and the other reviewers.

Your comments will be submitted to OSHA as received (i.e. unedited) and
may be made available to the public. ERG may, however, format your
comments as needed for consistency in the final peer review summary
report.

FORMATTING INSTRUCTIONS

Please prepare your comments addressing the issues and questions as
stated in the Technical Charge, and organize your comments by charge
question. To assist you in preparing your comments, ERG has provided you
with an electronic copy of the Technical Charge via email.

Additional format recommendations are as follows:

TYPE SIZE:	11 point		PAPER SIZE:	8.5" x 11"

SPACING:	1.5 line spacing		MARGINS:	1" margins

Please use a header with your name in the upper right-hand corner of
each page of your comments.

Organize your comments following the order of the charge questions.
Preferably, cut and paste the charge questions into your written
document and write your responses to each question.  If for some reason
you choose not to answer a question, please provide a reason why (e.g.,
question is outside my area of expertise, etc.).   Any comments you wish
to provide not associated with a charge question should be included at
the end of your responses.

Please provide a justification for your response when answering the
Charge Questions. Be as detailed as possible in your responses using
complete sentences.

Remember to spell out acronyms when first used.

Avoid incomplete sentences, abbreviations, and terms that might confuse
the reader.

If you are suggesting any additional references, please provide a full
citation, or electronic copy of the reference (if available).

If illustrations or tables are included, be sure that they are suitable
for reproduction.

Please send your comments electronically as an MS Word 2003 file or
later. If sending them via e-mail, send them to Kate Schalk at
HYPERLINK<EMAIL_ADDRESS><EMAIL_ADDRESS>.  If
mailing a CD, please mail them to: Kate Schalk, ERG, 110 Hartwell
Avenue, Lexington, MA  02421-3136.  Thank you.

 PAGE

 PAGE   3


[Federal Register Volume 87, Number 72 (Thursday, April 14, 2022)]
[Proposed Rules]
[Pages 22149-22153]
[FR Doc No: 2022-08005]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2022-0459; Project Identifier MCAI-2021-00266-E]
RIN 2120-AA64

Airworthiness Directives; GE Aviation Czech s.r.o. (Type
Certificate Previously Held by WALTER Engines a.s., Walter a.s., and
MOTORLET a.s.) Turboprop Engines

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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SUMMARY: The FAA proposes to adopt a new airworthiness directive (AD)
for all GE Aviation Czech s.r.o. (GEAC) M601D-11 model turboprop
engines. This proposed AD was prompted by the manufacturer revising the
airworthiness limitation section (ALS) of the existing engine
maintenance manual (EMM) to include a visual inspection of the
centrifugal compressor case for cracks. This proposed AD would require
revising the ALS of the existing EMM to incorporate a visual inspection
of the centrifugal compressor case. The FAA is proposing this AD to
address the unsafe condition on these products.

DATES: The FAA must receive comments on this proposed AD by May 31,
2022.

ADDRESSES: You may send comments, using the procedures found in 14 CFR
11.43 and 11.45, by any of the following methods:
     Federal eRulemaking Portal: Go to https://www.regulations.gov. Follow the instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE, Washington, DC 20590.
     Hand Delivery: Deliver to Mail address above between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays.
    For service information identified in this NPRM, contact GE
Aviation Czech, Beranov[yacute]ch 65, 199 02 Praha 9--Let[ncaron]any,
Czech Republic; phone: +420 222 538 999; email: [email protected]. You may
view this service information at the FAA, Airworthiness Products
Section, Operational Safety Branch, 1200 District Avenue, Burlington,
MA 01803. For information on the availability of this material at the
FAA, call<PHONE_NUMBER>.

Examining the AD Docket

    You may examine the AD docket at https://www.regulations.gov by
searching for and locating Docket No. FAA-2022-0459; or in person at
Docket Operations between 9 a.m. and 5 p.m., Monday through Friday,
except Federal holidays. The AD docket contains this NPRM, the
mandatory continuing airworthiness information (MCAI), any comments
received, and other information. The street address for Docket
Operations is listed above.

FOR FURTHER INFORMATION CONTACT: Barbara Caufield, Aviation Safety
Engineer, ECO Branch, FAA, 1200 District Avenue, Burlington, MA 01803;
phone:<PHONE_NUMBER>; email: [email protected].

SUPPLEMENTARY INFORMATION:

Comments Invited

    The FAA invites you to send any written relevant data, views, or
arguments about this proposal. Send your comments to an address listed
under ADDRESSES. Include ``Docket No. FAA-2022-0459; Project Identifier
MCAI-2021-00266-E'' at the beginning of your comments. The most helpful
comments reference a specific portion of the proposal, explain the
reason for any recommended change, and include supporting data. The FAA
will consider all comments received by the closing date and may amend
this NPRM because of those comments.
    Except for Confidential Business Information (CBI) as described in
the following paragraph, and other information as described in 14 CFR
11.35, the FAA will post all comments received, without change, to
https://www.regulations.gov, including any personal information you
provide. The agency will also post a report summarizing each
substantive verbal contact received about this NPRM.

Confidential Business Information

    CBI is commercial or financial information that is both customarily
and actually treated as private by its owner. Under the Freedom of
Information Act (FOIA) (5 U.S.C. 552), CBI is exempt from public
disclosure. If your comments responsive to this NPRM contain commercial
or financial information that is customarily treated as private, that
you actually treat as private, and that is relevant or responsive to
this NPRM, it is important that you clearly designate the submitted
comments as CBI. Please mark each page of your submission containing
CBI as ``PROPIN.'' The FAA will treat such marked submissions as
confidential under the FOIA, and they will not be placed in the public
docket of this NPRM. Submissions containing CBI should be sent to
Barbara Caufield, Aviation Safety Engineer, ECO Branch, FAA, 1200
District Avenue, Burlington, MA 01803. Any commentary that the FAA
receives which is not specifically designated as CBI will be placed in
the public docket for this rulemaking.

Background

    The European Union Aviation Safety Agency (EASA), which is the
Technical Agent for the Member States of the European Union, has issued
EASA AD 2021-0060, dated March 3, 2021 (referred to after this as ``the
MCAI''), to address the unsafe condition on these products. The MCAI
states:

    The airworthiness limitations for certain M601 engine models,
which are approved by

EASA, are currently defined and published in the ALS. These
instructions have been identified as mandatory for continued
airworthiness.
    Failure to accomplish these instructions could result in an
unsafe condition.
    Recently, GEAC published the ALS, as defined in this [EASA] AD,
introducing a visual inspection of the Centrifugal Compressor Case.
    For the reason described above, this [EASA] AD requires
accomplishment of the actions specified in the ALS.

    You may obtain further information by examining the MCAI in the AD
docket at https://www.regulations.gov by searching for and locating
Docket No. FAA-2022-0459.

FAA's Determination

    This product has been approved by EASA and is approved for
operation in the United States. Pursuant to the FAA's bilateral
agreement with the European Union, EASA has notified the FAA of the
unsafe condition described in the MCAI and service information. The FAA
is proposing this AD because the agency evaluated all the relevant
information provided by EASA and has determined the unsafe condition
described previously is likely to exist or develop in other products of
the same type design.

Related Service Information

    The FAA reviewed GE Aviation Czech Airworthiness Limitations R18,
Section 5. Mandatory Inspections, of the GE Aviation Czech EMM, Part
No. 0982309, Revision No. 18, dated December 18, 2020 (Airworthiness
Limitations R18, Section 5. Mandatory Inspections). Airworthiness
Limitations R18, Section 5. Mandatory Inspections, of the EMM specifies
procedures for performing a visual inspection of the centrifugal
compressor case for cracks.

Proposed AD Requirements in This NPRM

    This proposed AD would require revising the ALS of the existing EMM
to incorporate a visual inspection of the centrifugal compressor case
for cracks. An owner/operator (pilot) holding at least at least a
private pilot certificate may revise the ALS of the existing EMM, and
the owner/operator must enter compliance with the applicable paragraphs
of the AD into the aircraft records in accordance with 14 CFR
43.9(a)(1) through (4) and 14 CFR 91.417(a)(2)(v). This is an exception
to the FAA's standard maintenance regulations.

Differences Between This Proposed AD and the MCAI or Service
Information

    The MCAI specifies replacing each component before exceeding the
applicable life limit and accomplishing all the applicable maintenance
tasks within the thresholds and intervals, as defined in the ALS. This
proposed AD would require revising the ALS of the existing EMM to
incorporate a visual inspection of the centrifugal compressor case. The
MCAI specifies that if discrepancies are found during the
accomplishment of the EASA AD, to accomplish corrective actions in
accordance with existing GEAC instructions. The MCAI also specifies to
contact GEAC for approved instructions if a detected discrepancy cannot
be corrected using existing GEAC instruction. This proposed AD would
not require performing corrective actions in accordance with existing
GEAC instructions or contacting GEAC for approved instructions. The
MCAI specifies revising the aircraft maintenance program within 12
months from its effective date. This proposed AD would require revising
the ALS of the existing EMM to incorporate a visual inspection of the
centrifugal compressor case within 90 days after the effective date of
this proposed AD.
    The MCAI and GE Aviation Czech Airworthiness Limitations R18,
Section 5. Mandatory Inspections, apply to GEAC M601D-1, M601D-2,
M601D-11, M601D-11NZ, and M601Z model turboprop engines. This proposed
AD would not apply to GEAC M601D-1, M601D-2, M601D-11NZ, and M601Z
model turboprop engines because these model turboprop engines do not
have an FAA type certificate.

Costs of Compliance

    The FAA estimates that this AD, if adopted as proposed, would
affect 7 engines installed on airplanes of U.S. registry.
    The FAA estimates the following costs to comply with this proposed
AD:

                                                 Estimated Costs
----------------------------------------------------------------------------------------------------------------
                                                                                Cost per      Cost on U.S.
                Action                         Labor cost           Parts cost        product        operators
----------------------------------------------------------------------------------------------------------------
Revise the ALS of the EMM.............  1 work-hour x $85 per                 $0             $85            $595
                                         hour = $85.
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Authority for This Rulemaking

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

Regulatory Findings

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

List of Subjects in 14 CFR Part 39

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

The Proposed Amendment

    Accordingly, under the authority delegated to me by the
Administrator, the FAA proposes to amend 14 CFR part 39 as follows:

PART 39--AIRWORTHINESS DIRECTIVES

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

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

Sec.  39.13  [Amended]

0
2. The FAA amends Sec.  39.13 by adding the following new airworthiness
directive:

GE Aviation Czech s.r.o (Type Certificate previously held by WALTER
Engines a.s., Walter a.s., and MOTORLET a.s.): Docket No. FAA-2022-
0459; Project Identifier MCAI-2021-00266-E.

(a) Comments Due Date

    The FAA must receive comments on this airworthiness directive
(AD) by May 31, 2022.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to GE Aviation Czech s.r.o. M601D-11 model
turboprop engines.

(d) Subject

    Joint Aircraft System Component (JASC) Code 7230, Turbine Engine
Compressor Section.

(e) Unsafe Condition

    This AD was prompted by the manufacturer revising the
airworthiness limitation section (ALS) of the existing engine
maintenance manual (EMM) to include a visual inspection of the
centrifugal compressor case for cracks. The FAA is issuing this AD
to prevent failure of the centrifugal compressor case. The unsafe
condition, if not addressed, could result in failure of the
centrifugal compressor case, engine separation, and loss of the
airplane.

(f) Compliance

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

(g) Required Actions

    (1) Within 90 days after the effective date of this AD, revise
the ALS of the existing EMM by incorporating Figure 1 to paragraph
(g)(1) of this AD.
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    (2) After revising the ALS of the existing EMM required by
paragraph (g)(1) of this AD, no alternative inspection intervals may
be used unless they are approved as provided in paragraph (h) of
this AD.
    (3) The action required by paragraph (g)(1) of this AD may be
performed by the owner/operator (pilot) holding at least a private
pilot certificate and must be entered into the aircraft records
showing compliance with this AD in accordance with 14 CFR 43.9(a)(1)
through (4) and 14 CFR 91.417(a)(2)(v). The record must be
maintained as required by 14 CFR 91.417, 121.380, or 135.439.

(h) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, ECO Branch, FAA, has the authority to approve
AMOCs for this AD, if requested using the procedures found in 14 CFR
39.19. In accordance with 14 CFR 39.19, send your request to your
principal inspector or local Flight Standards District Office, as
appropriate. If sending information directly to the manager of the
ECO Branch, send it to the attention of the person identified in
paragraph (i)(1) of this AD and email: [email protected].
    (2) Before using any approved AMOC, notify your appropriate
principal inspector, or lacking a principal inspector, the manager
of the local flight standards district office/certificate holding
district office.

(i) Related Information

    (1) For more information about this AD, contact Barbara
Caufield, Aviation Safety Engineer, ECO Branch, FAA, 1200 District
Avenue, Burlington, MA 01803; phone:<PHONE_NUMBER>; email:
[email protected].
    (2) Refer to European Union Aviation Safety Agency (EASA) AD
2021-0060, dated March 3, 2021, for more information. You may
examine the EASA AD in the AD docket at https://www.regulations.gov
by searching for and locating it in Docket No. FAA-2022-0459.

    Issued on April 8, 2022.
Lance T. Gant,
Director, Compliance & Airworthiness Division, Aircraft Certification
Service.
[FR Doc. 2022-08005 Filed 4-13-22; 8:45 am]
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