Safety Zone; West Passage Narragansett Bay, Jamestown, RI, 70100-70103 [2024-19576]
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Federal Register / Vol. 89, No. 168 / Thursday, August 29, 2024 / Rules and Regulations
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3), in a manner that provides for
effective monitoring of devices and is
beneficial for FDA, industry, and the
public. An important part of this
voluntary program is providing
clarification to manufacturers regarding
the product codes eligible for the
program.
Consistent with the MDUFA IV
Commitment Letter (Ref. 3), FDA has
identified eligible product codes for the
Voluntary Malfunction Summary
Reporting Program in FDA’s Product
Classification Database, available on
FDA’s website https://www.fda.gov/
medical-devices/medical-devicereporting-mdr-how-report-medicaldevice-problems/voluntary-malfunctionsummary-reporting-program.
Manufacturers that choose to participate
in quarterly summary reporting through
this program will remain responsible for
complying with applicable MDR
requirements under part 803 (e.g.,
requirements to establish and maintain
MDR event files under § 803.18) and
quality system requirements under part
820 (21 CFR part 820) (e.g., the
requirement to evaluate, review, and
investigate any complaint that
represents an MDR reportable event
under § 820.198).
If FDA determines that individual
malfunction reports are necessary from
a specific manufacturer or for specific
devices, FDA will notify relevant
manufacturers that they must submit
individual reports and provide an
explanation for that decision and, as
appropriate, the steps necessary to
return to summary, quarterly reporting.
The Agency also notes that, under
§ 803.19(d), it may revoke or modify in
writing an exemption, variance, or
alternative reporting requirement if it
determines that revocation or
modification is necessary to protect the
public health.
V. Updating Product Codes for
Inclusion Into the Program
FDA recognizes that new product
codes will be created in the future. In
general, as explained in the document
published in 2018 (83 FR 40973, August
17, 2018), FDA does not intend to
consider devices under product codes in
existence for fewer than 2 years to be
eligible for the program, unless the new
product code was issued solely for
administrative reasons. However, FDA
will periodically evaluate new product
codes after they have been in existence
for 2 years to determine whether they
should be added to the list of product
codes eligible for the Voluntary
Malfunction Summary Reporting
Program. If FDA determines that a new
product code should be added, then it
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will grant manufacturers of devices
within that product code the same
alternative under § 803.19 for
malfunction events associated with
those devices and update FDA’s Product
Classification database accordingly to
reflect the changes.
Manufacturers can send a request for
a product code to be added to the list
of eligible product codes and for
manufacturers of devices within that
product code to be granted the same
alternative for malfunction events
associated with those devices to the
MDRPolicy@fda.hhs.gov mailbox.
VI. Conclusion
In accordance with section
519(a)(1)(B)(i) of the FD&C Act and
§ 803.19(d), FDA is modifying the
alternative granted to manufacturers of
devices in eligible product codes, as
identified in the FDA’s Product
Classification Database, available on
FDA’s website https://www.fda.gov/
medical-devices/medical-devicereporting-mdr-how-report-medicaldevice-problems/voluntary-malfunctionsummary-reporting-program, for the
Voluntary Malfunction Summary
Reporting Program. Specifically, we are
modifying the malfunction summary
reporting format to enhance consistency
with the revised Form FDA 3500A and
to update FDA references to MDR
adverse event codes, as well as to make
a few editorial changes for additional
clarity. This modification will help
ensure the accuracy and consistency of
summary malfunction reporting
information submitted to FDA and thus
help protect the public health.
VII. Analysis of Environmental Impact
The Agency has determined under 21
CFR 25.30(h) that this action is of a type
that does not individually or
cumulatively have a significant effect on
the human environment. Therefore,
neither an environmental assessment
nor an environmental impact statement
is required.
VIII. References
The following references marked with
an asterisk (*) are on display at the
Dockets Management Staff (HFA–305),
Food and Drug Administration, 5630
Fishers Lane, Rm. 1061, Rockville, MD
20852, 240–402–7500, and are available
for viewing by interested persons
between 9 a.m. and 4 p.m., Monday
through Friday; they also are available
electronically at https://
www.regulations.gov. References
without asterisks are not on public
display at https://www.regulations.gov
because they have copyright restriction.
Some may be available at the website
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address, if listed. References without
asterisks are available for viewing only
at the Dockets Management Staff.
Although FDA has verified the website
addresses in this document, please note
that websites are subject to change over
time.
1. FDA. MedWatch Form FDA 3500A.
Available at: https://www.fda.gov/safety/
medical-product-safety-information/
medwatch-forms-fda-safety-reporting.
2. FDA. Electronic Medical Device Reporting
(eMDR) website. Available at: https://
www.fda.gov/industry/fda-esubmitter/
electronic-medical-device-reportingemdr.
3. * FDA. Medical Device User Fee
Agreement IV Commitment Letter.
Available at: https://www.fda.gov/
downloads/ForIndustry/UserFees/
MedicalDeviceUserFee/UCM535548.pdf.
Dated: August 23, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024–19414 Filed 8–28–24; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HOMELAND
SECURITY
Coast Guard
33 CFR Part 165
[Docket Number USCG–2024–0559]
RIN 1625–AA00
Safety Zone; West Passage
Narragansett Bay, Jamestown, RI
Coast Guard, DHS.
Temporary interim rule and
request for comments.
AGENCY:
ACTION:
The Coast Guard is
establishing a temporary safety zone for
navigable waters within a 250-yard
radius of the MARMAC 306 cable laying
barge, and a J.F. Brennan construction
barge #4132. The safety zone is needed
to protect personnel, vessels, and the
marine environment from potential
hazards created by cable laying
operations being conducted in the
vicinity of the West Passage
Narragansett Bay, Jamestown, RI,
between the Jamestown Verrazzano
Bridge and south to Dutch Island. When
enforced, entry of vessels or persons
into this zone is prohibited unless
specifically authorized by the Captain of
the Port, Sector Southeastern New
England.
SUMMARY:
DATES:
Effective date: This temporary interim
rule is effective from 12:01 a.m. on
September 1, 2024, through 11:59 p.m.
on December 31, 2024. The rule will
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only be subject to enforcement while the
MARMAC 306 cable laying barge and
J.F. Brennan construction barge #4132
are engaged in operations.
Comment date: Comments and related
material must be received by the Coast
Guard on or before September 30, 2024.
ADDRESSES: To view documents
mentioned in this preamble as being
available in the docket, go to https://
www.regulations.gov, type USCG–2024–
0559 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 about this rule, call
or email MST2 Nicholas Easley, Sector
Southeastern New England, U.S. Coast
Guard; telephone 206–827–4160, email
Nicholas.S.Easley@uscg.mil.
SUPPLEMENTARY INFORMATION:
I. Table of Abbreviations
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CFR Code of Federal Regulations
COTP Captain of the Port Sector
Southeastern New England
DHS Department of Homeland Security
FR Federal Register
NPRM Notice of proposed rulemaking
§ Section
U.S.C. United States Code
II. Background Information and
Regulatory History
On May 31, 2024, Orsted, an offshore
wind energy developer, made the Coast
Guard aware of their plans for cable
laying operations associated with the
Revolution Wind Farm project in
vicinity of West Passage Narragansett
Bay, Jamestown, RI, between Jamestown
Verrazzano Bridge, and south to Dutch
Island. The cable laying operation
involves the use of a MARMAC 306
barge and J.F. Brennan construction
barge #4132 that will utilize a thruster
system and five high tension anchors
extending out from each barge to
maintain its position. At times the
anchor lines may lie just below the
surface of the water.
The Coast Guard is issuing this
temporary rule under the authority in 5
U.S.C. 553(b)(B). This statutory
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.’’ The Coast Guard finds that
good cause exists for not publishing a
notice of proposed rulemaking (NPRM)
with respect to this rule because doing
so would be impracticable and contrary
to the public interest. The details of the
project were not known to the Coast
Guard in sufficient time to publish an
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NPRM. Delaying the effective date of
this rule to wait for a comment period
to run would be impracticable and
contrary to the public interest because it
would inhibit the Coast Guard’s ability
to protect the public and vessels from
the hazards associated with the cable
laying process. The expeditious
implementation of this rule is in the
public interest because it will help
ensure the safety of personnel,
waterway users, and the marine
environment.
Also, 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 impracticable
because prompt action is needed to
respond to the potential safety hazards
associated with the cable installation
being conducted by the MARMAC 306
barge and J.F. Brennan construction
barge #4132.
We are soliciting comments on this
rulemaking. If the Coast Guard
determines that changes to the
temporary interim rule are necessary,
we will publish a temporary final rule
or other appropriate document.
III. Legal Authority and Need for Rule
The Coast Guard is issuing this rule
under the authority in 46 U.S.C. 70034.
The Captain of the Port Sector
Southeastern New England (COTP) has
determined that potential hazards
associated with the cable installation
starting on September 1, 2024, will be
a safety concern for anyone within a
250-yard radius of the MARMAC 306
barge and J.F. Brennan construction
barge #4132. This rule is needed to
protect personnel, vessels, and the
marine environment in the navigable
waters within the safety zone while the
cable installation is being conducted.
IV. Discussion of the Rule
This rule establishes a temporary
safety zone from 12:01 a.m. on
September 1, 2024, until 11:59 p.m. on
December 31, 2024. While the safety
zone will be effective through this
period, it will only be enforced during
active submerged cable laying
operations or other instances which may
create a hazard to navigation. The safety
zone will cover all navigable waters
within 250 yards of the barge MARMAC
306 and J.F. Brennan construction barge
#4132 while they are operating in the
vicinity of the West Passage
Narragansett Bay, Jamestown, RI,
between the Jamestown Verrazzano
Bridge (41°31′43.7″ N 71°24′18.2″ W)
and south to Dutch Island (41°29′47.3″
N, 71°24′16.5″ W). During times of
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enforcement, all persons or vessels
would be prohibited from entering the
safety zone without permission from the
COTP or a designated representative. If
cable laying operations and associated
operations are completed before 11:59
p.m. on December 31, 2024,
enforcement of the safety zone will be
suspended, and notice given via
Broadcast Notice to Mariners.
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
section 3(f) of Executive Order 12866, as
amended by Executive Order 14094
(Modernizing Regulatory Review).
Accordingly, this rule has not been
reviewed by the Office of Management
and Budget (OMB).
This regulatory action determination
is based on the size, location, duration,
and time-of-day of the safety zone.
Vessel traffic will be able to safely
transit around the safety zone which
would impact a 250-yard radius around
the MARMAC 306 and J.F. Brennan
construction barge #4132 while engaged
in cable laying operations. The Coast
Guard will issue a Broadcast Notice to
Mariners via VHF–FM marine channel
16 about the zone, and the rule would
allow vessels to seek permission to enter
the zone.
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 the
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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).
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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.
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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 a safety
zone, lasting only during the hours of
operation of the MARMAC 306 J.F.
Brennan construction barge #4132, that
will prohibit entry within 250 yards of
vessels and machinery being used by
personnel to install the cable. It is
categorically excluded from further
review under paragraph L60a of
Appendix A, Table 1 of DHS Instruction
Manual 023–01–001–01, Rev. 1. 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.
VI. Public Participation and Request for
Comments
We view public participation as
essential to effective rulemaking and
will consider all comments and material
received during the comment period. If
we determine that changes to the
temporary interim rule are necessary,
the Coast Guard will publish a
temporary final rule or other
appropriate document. If you submit a
comment, please include the docket
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number for this rulemaking, indicate the
specific section of this document to
which each comment applies, and
provide a reason for each suggestion or
recommendation.
Submitting comments. We encourage
you to submit comments through the
Federal Decision-Making Portal at
https://www.regulations.gov. To do so,
go to https://www.regulations.gov, type
USCG–2024–0559 in the search box and
click ‘‘Search.’’ Next, look for this
document in the Search Results column,
and click on it. Then click on the
Comment option. If you cannot submit
your material by using https://
www.regulations.gov, call or email the
person in the FOR FURTHER INFORMATION
CONTACT section of this proposed rule
for alternate instructions.
Viewing material in docket. To view
documents mentioned in this proposed
rule as being available in the docket,
find the docket as described in the
previous paragraph, and then select
‘‘Supporting & Related Material’’ in the
Document Type column. Public
comments will also be placed in our
online docket and can be viewed by
following instructions on the https://
www.regulations.gov Frequently Asked
Questions web page. Also, if you click
on the Dockets tab and then the
proposed rule, you should see a
‘‘Subscribe’’ option for email alerts. The
option will notify you when comments
are posted, or a final rule is published.
We review all comments received, but
we will only post comments that
address the topic of the proposed rule.
We may choose not to post off-topic,
inappropriate, or duplicate comments
that we receive.
Personal information. We accept
anonymous comments. Comments we
post to https://www.regulations.gov will
include any personal information you
have provided. For more about privacy
and submissions to the docket in
response to this document, see DHS’s
eRulemaking System of Records notice
(85 FR 14226, March 11, 2020).
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
1. The authority citation for part 165
continues to read as follows:
■
Authority: 46 U.S.C. 70034, 70051, 70124;
33 CFR 1.05–1, 6.04–1, 6.04–6, and 160.5;
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Department of Homeland Security Delegation
No. 00170.1, Revision No. 01.3.
ENVIRONMENTAL PROTECTION
AGENCY
2. Add § 165.T01–0559 to read as
follows:
40 CFR Part 180
■
§ 165.T01–0559 Safety Zone; West
Passage Narragansett Bay, Jamestown, RI.
(a) Location. The following area is a
safety zone: All waters within a 250yard radius of the MARMAC 306 cable
laying barge and J.F. Brennan
construction barge #4132 while
operating in West Passage Narraganset
Bay, Jamestown, RI, between Jamestown
Verrazzano Bridge (41°31′43.7″ N
71°24′18.2″ W) and Dutch Island
(41°29′47.3″ N, 71°24′16.5″ W).
(b) Definitions. As used in this
section, Designated Representative
means a Coast Guard Patrol
Commander, including a Coast Guard
coxswain, petty officer, or other officer
operating a Coast Guard vessel and a
Federal, State, and local officer
designated by or assisting the Captain of
the Port Sector Southeastern New
England (COTP) in the enforcement of
the safety zone.
(c) Regulations. (1) Under the general
safety zone regulations in subpart C of
this part, you may not enter the safety
zone described in paragraph (a) of this
section unless authorized by the COTP
or the COTP’s designated representative.
(2) To seek permission to enter,
contact the COTP or the COTP’s
representative by VHF–FM radio
channel 16 or phone at 866–819–9128.
Those in the safety zone must comply
with all lawful orders or directions
given to them by the COTP or the
COTP’s designated representative.
(d) Enforcement period. This section
is effective from 12:01 a.m. on Sunday,
September 1, 2024, through 11:59 p.m.
on Tuesday, December 31, 2024. The
safety zone described in paragraph (a) of
this section will only be subject to
enforcement while the MARMAC 306
cable laying barge and J.F. Brennan
construction barge #4132 are engaged in
cable laying operations.
Y. Moon,
Captain, U.S. Coast Guard, Captain of the
Port Sector Southeastern New England.
[FR Doc. 2024–19576 Filed 8–28–24; 8:45 am]
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BILLING CODE 9110–04–P
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[EPA–HQ–OPP–2023–0208; FRL–12187–01–
OCSPP]
Tetraacetylethylenediamine (TAED),
and Its Metabolite
Diacetylethylenediamine (DAED);
Exemption From the Requirement of a
Pesticide Tolerance
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
This regulation establishes an
exemption from the requirement of a
tolerance for residues of
tetraacetylethylenediamine (TAED),
including its metabolites and
degradates, on or applied to food
contact surfaces in public eating places,
dairy processing equipment, and food
processing equipment and utensils. This
tolerance exemption is established on
the Agency’s own initiative under the
Federal Food, Drug, and Cosmetic Act
(FFDCA), in order to implement the
tolerance actions EPA identified during
its review of this chemical as part of the
Agency’s registration review program
under the Federal Insecticide,
Fungicide, and Rodenticide Act
(FIFRA).
SUMMARY:
This regulation is effective
August 29, 2024. Objections and
requests for hearings must be received
on or before October 28, 2024 and must
be filed in accordance with the
instructions provided in 40 CFR part
178 (see also Unit I.C. of the
SUPPLEMENTARY INFORMATION).
ADDRESSES: The docket for this action,
identified by docket identification (ID)
number EPA–HQ–OPP–2023–0208, is
available at https://www.regulations.gov
or at the Office of Pesticide Programs
Regulatory Public Docket (OPP Docket)
in the Environmental Protection Agency
Docket Center (EPA/DC), West William
Jefferson Clinton Bldg., Rm. 3334, 1301
Constitution Ave. NW, Washington, DC
20460–0001. The Public Reading Room
is open from 8:30 a.m. to 4:30 p.m.,
Monday through Friday, excluding legal
holidays. The telephone number for the
Public Reading Room and the OPP
docket is (202) 566–1744. Please review
the visitor instructions and additional
information about the docket available
at https://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT:
Anita Pease, Antimicrobials Division
(7510M), Office of Pesticide Programs,
Environmental Protection Agency, 1200
Pennsylvania Ave. NW, Washington, DC
DATES:
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70103
20460–0001; telephone number: (202)
566–0736; email address: pease.anita@
epa.gov or ADFRNotices@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this action apply to me?
You may be potentially affected by
this action if you are a pesticide
manufacturer. The following list of
North American Industrial
Classification System (NAICS) codes is
not intended to be exhaustive, but rather
provides a guide to help readers
determine whether this document
applies to them. Potentially affected
entities may include:
• Food manufacturing (NAICS code
311).
• Pesticide manufacturing (NAICS
code 32532).
• Restaurant kitchen cleaning
services (NAICS code 561720).
• Milk production, dairy cattle
(NAICS code 112120).
• Food processing machinery and
equipment merchant wholesalers
(NAICS code 423830).
B. How can I get electronic access to
other related information?
You may access a frequently updated
electronic version of 40 CFR part 180
through the Office of the Federal
Register’s e-CFR site at https://
www.ecfr.gov/current/title-40.
C. How can I file an objection or hearing
request?
Under FFDCA section 408(g), 21
U.S.C. 346a, any person may file an
objection to any aspect of this regulation
and may also request a hearing on those
objections. You must file your objection
or request a hearing on this regulation
in accordance with the instructions
provided in 40 CFR part 178. To ensure
proper receipt by EPA, you must
identify docket ID number EPA–HQ–
OPP–2023–0208 in the subject line on
the first page of your submission. All
objections and requests for a hearing
must be in writing and must be received
by the Hearing Clerk in the Office of the
Administrative Law Judges on or before
October 28, 2024. Notwithstanding the
procedural requirements of 40 CFR
178.25(b), the Office of the
Administrative Law Judges has issued
an order urging parties to file and serve
documents with the Tribunal by
electronic means only. See Revised
Order Urging Electronic Filing and
Service (dated June 22, 2023), https://
www.epa.gov/system/files/documents/
2023-06/2023-06-22%20%20revised%20order%20
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29AUR1
Agencies
[Federal Register Volume 89, Number 168 (Thursday, August 29, 2024)]
[Rules and Regulations]
[Pages 70100-70103]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-19576]
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DEPARTMENT OF HOMELAND SECURITY
Coast Guard
33 CFR Part 165
[Docket Number USCG-2024-0559]
RIN 1625-AA00
Safety Zone; West Passage Narragansett Bay, Jamestown, RI
AGENCY: Coast Guard, DHS.
ACTION: Temporary interim rule and request for comments.
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SUMMARY: The Coast Guard is establishing a temporary safety zone for
navigable waters within a 250-yard radius of the MARMAC 306 cable
laying barge, and a J.F. Brennan construction barge #4132. The safety
zone is needed to protect personnel, vessels, and the marine
environment from potential hazards created by cable laying operations
being conducted in the vicinity of the West Passage Narragansett Bay,
Jamestown, RI, between the Jamestown Verrazzano Bridge and south to
Dutch Island. When enforced, entry of vessels or persons into this zone
is prohibited unless specifically authorized by the Captain of the
Port, Sector Southeastern New England.
DATES:
Effective date: This temporary interim rule is effective from 12:01
a.m. on September 1, 2024, through 11:59 p.m. on December 31, 2024. The
rule will
[[Page 70101]]
only be subject to enforcement while the MARMAC 306 cable laying barge
and J.F. Brennan construction barge #4132 are engaged in operations.
Comment date: Comments and related material must be received by the
Coast Guard on or before September 30, 2024.
ADDRESSES: To view documents mentioned in this preamble as being
available in the docket, go to https://www.regulations.gov, type USCG-
2024-0559 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 about this rule,
call or email MST2 Nicholas Easley, Sector Southeastern New England,
U.S. Coast Guard; telephone 206-827-4160, email
[email protected].
SUPPLEMENTARY INFORMATION:
I. Table of Abbreviations
CFR Code of Federal Regulations
COTP Captain of the Port Sector Southeastern New England
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
On May 31, 2024, Orsted, an offshore wind energy developer, made
the Coast Guard aware of their plans for cable laying operations
associated with the Revolution Wind Farm project in vicinity of West
Passage Narragansett Bay, Jamestown, RI, between Jamestown Verrazzano
Bridge, and south to Dutch Island. The cable laying operation involves
the use of a MARMAC 306 barge and J.F. Brennan construction barge #4132
that will utilize a thruster system and five high tension anchors
extending out from each barge to maintain its position. At times the
anchor lines may lie just below the surface of the water.
The Coast Guard is issuing this temporary rule under the authority
in 5 U.S.C. 553(b)(B). This statutory 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.'' The Coast Guard
finds that good cause exists for not publishing a notice of proposed
rulemaking (NPRM) with respect to this rule because doing so would be
impracticable and contrary to the public interest. The details of the
project were not known to the Coast Guard in sufficient time to publish
an NPRM. Delaying the effective date of this rule to wait for a comment
period to run would be impracticable and contrary to the public
interest because it would inhibit the Coast Guard's ability to protect
the public and vessels from the hazards associated with the cable
laying process. The expeditious implementation of this rule is in the
public interest because it will help ensure the safety of personnel,
waterway users, and the marine environment.
Also, 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 impracticable because prompt action is needed to
respond to the potential safety hazards associated with the cable
installation being conducted by the MARMAC 306 barge and J.F. Brennan
construction barge #4132.
We are soliciting comments on this rulemaking. If the Coast Guard
determines that changes to the temporary interim rule are necessary, we
will publish a temporary final rule or other appropriate document.
III. Legal Authority and Need for Rule
The Coast Guard is issuing this rule under the authority in 46
U.S.C. 70034. The Captain of the Port Sector Southeastern New England
(COTP) has determined that potential hazards associated with the cable
installation starting on September 1, 2024, will be a safety concern
for anyone within a 250-yard radius of the MARMAC 306 barge and J.F.
Brennan construction barge #4132. This rule is needed to protect
personnel, vessels, and the marine environment in the navigable waters
within the safety zone while the cable installation is being conducted.
IV. Discussion of the Rule
This rule establishes a temporary safety zone from 12:01 a.m. on
September 1, 2024, until 11:59 p.m. on December 31, 2024. While the
safety zone will be effective through this period, it will only be
enforced during active submerged cable laying operations or other
instances which may create a hazard to navigation. The safety zone will
cover all navigable waters within 250 yards of the barge MARMAC 306 and
J.F. Brennan construction barge #4132 while they are operating in the
vicinity of the West Passage Narragansett Bay, Jamestown, RI, between
the Jamestown Verrazzano Bridge (41[deg]31'43.7'' N 71[deg]24'18.2'' W)
and south to Dutch Island (41[deg]29'47.3'' N, 71[deg]24'16.5'' W).
During times of enforcement, all persons or vessels would be prohibited
from entering the safety zone without permission from the COTP or a
designated representative. If cable laying operations and associated
operations are completed before 11:59 p.m. on December 31, 2024,
enforcement of the safety zone will be suspended, and notice given via
Broadcast Notice to Mariners.
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 section 3(f) of Executive Order 12866, as
amended by Executive Order 14094 (Modernizing Regulatory Review).
Accordingly, this rule has not been reviewed by the Office of
Management and Budget (OMB).
This regulatory action determination is based on the size,
location, duration, and time-of-day of the safety zone. Vessel traffic
will be able to safely transit around the safety zone which would
impact a 250-yard radius around the MARMAC 306 and J.F. Brennan
construction barge #4132 while engaged in cable laying operations. The
Coast Guard will issue a Broadcast Notice to Mariners via VHF-FM marine
channel 16 about the zone, and the rule would allow vessels to seek
permission to enter the zone.
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 the
[[Page 70102]]
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 a
safety zone, lasting only during the hours of operation of the MARMAC
306 J.F. Brennan construction barge #4132, that will prohibit entry
within 250 yards of vessels and machinery being used by personnel to
install the cable. It is categorically excluded from further review
under paragraph L60a of Appendix A, Table 1 of DHS Instruction Manual
023-01-001-01, Rev. 1. 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.
VI. Public Participation and Request for Comments
We view public participation as essential to effective rulemaking
and will consider all comments and material received during the comment
period. If we determine that changes to the temporary interim rule are
necessary, the Coast Guard will publish a temporary final rule or other
appropriate document. If you submit a comment, please include the
docket number for this rulemaking, indicate the specific section of
this document to which each comment applies, and provide a reason for
each suggestion or recommendation.
Submitting comments. We encourage you to submit comments through
the Federal Decision-Making Portal at https://www.regulations.gov. To
do so, go to https://www.regulations.gov, type USCG-2024-0559 in the
search box and click ``Search.'' Next, look for this document in the
Search Results column, and click on it. Then click on the Comment
option. If you cannot submit your material by using https://www.regulations.gov, call or email the person in the FOR FURTHER
INFORMATION CONTACT section of this proposed rule for alternate
instructions.
Viewing material in docket. To view documents mentioned in this
proposed rule as being available in the docket, find the docket as
described in the previous paragraph, and then select ``Supporting &
Related Material'' in the Document Type column. Public comments will
also be placed in our online docket and can be viewed by following
instructions on the https://www.regulations.gov Frequently Asked
Questions web page. Also, if you click on the Dockets tab and then the
proposed rule, you should see a ``Subscribe'' option for email alerts.
The option will notify you when comments are posted, or a final rule is
published.
We review all comments received, but we will only post comments
that address the topic of the proposed rule. We may choose not to post
off-topic, inappropriate, or duplicate comments that we receive.
Personal information. We accept anonymous comments. Comments we
post to https://www.regulations.gov will include any personal
information you have provided. For more about privacy and submissions
to the docket in response to this document, see DHS's eRulemaking
System of Records notice (85 FR 14226, March 11, 2020).
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, 70124; 33 CFR 1.05-1, 6.04-
1, 6.04-6, and 160.5;
[[Page 70103]]
Department of Homeland Security Delegation No. 00170.1, Revision No.
01.3.
0
2. Add Sec. 165.T01-0559 to read as follows:
Sec. 165.T01-0559 Safety Zone; West Passage Narragansett Bay,
Jamestown, RI.
(a) Location. The following area is a safety zone: All waters
within a 250-yard radius of the MARMAC 306 cable laying barge and J.F.
Brennan construction barge #4132 while operating in West Passage
Narraganset Bay, Jamestown, RI, between Jamestown Verrazzano Bridge
(41[deg]31'43.7'' N 71[deg]24'18.2'' W) and Dutch Island
(41[deg]29'47.3'' N, 71[deg]24'16.5'' W).
(b) Definitions. As used in this section, Designated Representative
means a Coast Guard Patrol Commander, including a Coast Guard coxswain,
petty officer, or other officer operating a Coast Guard vessel and a
Federal, State, and local officer designated by or assisting the
Captain of the Port Sector Southeastern New England (COTP) in the
enforcement of the safety zone.
(c) Regulations. (1) Under the general safety zone regulations in
subpart C of this part, you may not enter the safety zone described in
paragraph (a) of this section unless authorized by the COTP or the
COTP's designated representative.
(2) To seek permission to enter, contact the COTP or the COTP's
representative by VHF-FM radio channel 16 or phone at 866-819-9128.
Those in the safety zone must comply with all lawful orders or
directions given to them by the COTP or the COTP's designated
representative.
(d) Enforcement period. This section is effective from 12:01 a.m.
on Sunday, September 1, 2024, through 11:59 p.m. on Tuesday, December
31, 2024. The safety zone described in paragraph (a) of this section
will only be subject to enforcement while the MARMAC 306 cable laying
barge and J.F. Brennan construction barge #4132 are engaged in cable
laying operations.
Y. Moon,
Captain, U.S. Coast Guard, Captain of the Port Sector Southeastern New
England.
[FR Doc. 2024-19576 Filed 8-28-24; 8:45 am]
BILLING CODE 9110-04-P