Consideration for Acceptance of One or More Viability Testing Methods for Type Approval of Ballast Water Management Systems, 67646-67651 [2024-18597]
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Federal Register / Vol. 89, No. 162 / Wednesday, August 21, 2024 / Notices
Division of Targeted Prevention, Center
for Substance Abuse Prevention,
Substance Abuse and Mental Health
Services Administration, 5600 Fishers
Lane, Rockville, MD 20857, email: DTPNOFO@samhsa.hhs.gov.
SUPPLEMENTARY INFORMATION:
lotter on DSK11XQN23PROD with NOTICES1
Funding Opportunity Title: FY 2021
Tribal Behavioral Health Grant Program
(Short Title: Native Connections) SM–
21–011.
Assistance Listing Number: 93.243.
Authority: Sections 520A (290bb–32)
and 516 (290bb–22) of the Public Health
Service Act, as amended.
Justification: These supplement
awards will be offered to the FY 2022
cohort under the Tribal Behavioral
Health/Native Connections (SM–21–
011) program supporting recipients in
developing and establishing a ToT
comprehensive program based on a
culturally appropriate curriculum
(developed by the recipient) that
leverages lessons learned from
recipient’s current substance use,
overdose, and suicide prevention
activities. Utilizing a ToT Model is a
low-cost approach to advancing
evidenced-based prevention
interventions while rapidly building a
network of multiple knowledgeable and
skilled trainers and thus enhancing
tribal workforce capacity and reach.
Trainers can rapidly support a broader
reach, rapid dissemination, and
increased sustainability among AI/AN
communities. Empowering participants
from within and reflective of the
communities served to take part in
designing and implementing programs
can expand proper identification and
address specific needs, rather than
following top-down, prescriptive
approaches. This cascade effect can
effectively eliminate barriers and
enhance engagement.
This is not a formal request for
application. Assistance will only be
provided to the 12 Native Connections
grant recipients funded in FY 2022
under the Tribal Behavioral Health
Grant Program, NOFO (SM–21–011)
based on the receipt of a satisfactory
application and associated budget that
is approved by a review group.
Date: August 15, 2024.
Ann Ferrero,
Public Health Analyst.
[FR Doc. 2024–18638 Filed 8–20–24; 8:45 am]
17:17 Aug 20, 2024
Coast Guard
[Docket No. USCG–2024–0501]
Consideration for Acceptance of One
or More Viability Testing Methods for
Type Approval of Ballast Water
Management Systems
Coast Guard, DHS.
Notice of intent to prepare a
Programmatic Environmental Impact
Statement; notice of virtual scoping
meetings; and request for comments.
AGENCY:
ACTION:
The Coast Guard, as the lead
agency, announces its intent to prepare
the Viability Testing Method
Consideration for Acceptance
Programmatic Environmental Impact
Statement. Through this document, we
will evaluate the potential
environmental impact of the Coast
Guard’s Proposed Action to use the best
available science to evaluate one or
more viability testing methods
submitted for consideration. Through
this document, we will also evaluate,
and potentially accept, methods that
demonstrate that ballast water discharge
meets U.S. ballast water discharge
performance standards currently under
development by the Environmental
Protection Agency.
DATES: Comments must be submitted
orally at one of the public meetings or
in writing the online docket via https://
www.regulations.gov on or before
October 7, 2024. Virtual public meetings
regarding this notice of intent will be
held Thursday, September 5, 2024, at 12
p.m. EST, Tuesday, September 10, 2024
at 4 p.m. EST, and Wednesday,
September 11, 2024 at 7 p.m. EST.
ADDRESSES: You may submit comments
identified by docket number USCG–
2024–0501 using the Federal DecisionMaking Portal at https://
www.regulations.gov. See the ‘‘Public
Participation and Request for
Comments’’ portion of the
SUPPLEMENTARY INFORMATION section for
further instructions on submitting
comments.
SUMMARY:
For
information about this document, call or
email Commander Andrew Murphy,
Coast Guard; telephone 202–372–1430;
email CG-OES@uscg.mil.
SUPPLEMENTARY INFORMATION:
FOR FURTHER INFORMATION CONTACT:
Public Participation and Request for
Comments
We encourage you to submit
comments and related material on
preliminary alternatives to help the
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SECURITY
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Coast Guard identify reasonable
alternatives. We will consider all
submissions and may adjust our final
action based on your comments. If you
submit a comment, please include the
docket number for this notice, indicate
the specific item 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–2024–0501 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 your material
cannot be submitted using https://
www.regulations.gov, contact the person
in the FOR FURTHER INFORMATION
CONTACT section of this document for
alternate instructions.
Viewing material in docket. Public
comments will be placed in our online
docket and can be viewed by following
instructions on the https://
www.regulations.gov Frequently Asked
Questions web page. We review all
comments received, but 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 in response to this
document, see DHS’s eRulemaking
System of Records notice (85 FR 14226,
March 11, 2020).
Public Meeting
We plan to hold three virtual public
scoping meetings to solicit feedback. At
these meetings, the Coast Guard will
present an overview of the Proposed
Action and the environmental review
process, followed by a period of
listening to oral comments from the
public. The Coast Guard will record all
oral comments and respond to them in
the Draft PEIS. The public meetings will
be held virtually in Microsoft Teams at
the following dates below. The public
meetings can be accessed by either
Microsoft Teams or by telephone.
Thursday, September 5, 2024
12:00 p.m. EST (4:00 p.m. UTC)
Meeting Link: https://tinyurl.com/
CGVIDAVT1
Meeting ID: 242 571 871 890
Passcode: DD7bEW
Phone-in: +1 202–660–1181
Phone conference ID: 925 558 1#
Tuesday, September 10, 2024
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Federal Register / Vol. 89, No. 162 / Wednesday, August 21, 2024 / Notices
4:00 p.m. EST (8:00 p.m. UTC)
Meeting Link: https://tinyurl.com/
CGVIDAVT2
Meeting ID: 294 512 529 402
Passcode: 8wzmy4
Phone-in: +1 202–660–1181
Phone conference ID: 567 920 777#
Wednesday, September 11, 2024
7:00 p.m. EST (11:00 p.m. UTC)
Meeting Link: https://tinyurl.com/
CGVIDAVT3
Meeting ID: 265 269 415 521
Passcode: jhEUSk
Phone-in: +1 202–660–1181
Phone conference ID: 125 105 712#
For information on facilities or
services for individuals with disabilities
or to request special assistance at the
public meeting, contact the person
named in the FOR FURTHER INFORMATION
CONTACT section, above.
Abbreviations
ANS Aquatic nuisance species
ATP Adenosine triphosphate
BWMS Ballast Water Management System
CDNA Complementary DNA
CEQ Council on Environmental Quality
CMFDA 5-chloromethylfluorescein
diacetate
CFR Code of Federal Regulations
DHS Department of Homeland Security
EIS Environmental Impact Statement
EPA Environmental Protection Agency
ETV Environmental Technology
Verification
FDA Fluorescein diacetate
IMO International Maritime Organization
mm Micrometer
MPN Most probable number
NEPA National Environmental Policy Act
NOI Notice of Intent
PCR Polymerase chain reaction
PEIS Programmatic Environmental Impact
Statement
qPCR Quantitative polymerase chain
reaction
SDC–MPN Serial dilution culture most
probable number
U.S.C. United States Code
USEPA United States Environmental
Protection Agency
VIDA Vessel Incidental Discharge Act
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Background
Currently, Coast Guard type approval
is granted for ballast water management
systems (BWMSs) that meet the live/
dead standard under protocols
described in title 46 of the Code of
Federal Regulations (CFR) and the
Environmental Protection Agency’s
(EPA’s) Environmental Technology
Verification (ETV) Program (EPA 2010),
which include the use of cell tracing
stains (such as fluorescein diacetate or
(FDA) 5-chloromethylfluorescein
diacetate (CMFDA), and do not include
the use of viability tests. The Vessel
Incidental Discharge Act (VIDA) of
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2018 1 allows the Coast Guard to
consider the use of viability tests for the
type approval of BWMS and directs the
Coast Guard to not consider methods for
viability that rely on staining to measure
the concentrations of organisms that are
between (or equivalent to) 10 and 50
micrometers (mm).
This Notice of Intent (NOI) is
intended to solicit feedback on the
scope of the Programmatic
Environmental Impact Statement (PEIS).
The Coast Guard intends to host three
virtual scoping meetings to provide
additional information to the public and
to solicit input on potential issues,
concerns, and reasonable alternatives
that should be considered in the PEIS.
Discussion
Congress, through enacting VIDA
required the Coast Guard to consider
adding ‘‘viability’’ of organisms as a way
of testing compliance with ballast water
discharge standards.
Ballast water is taken on by a vessel
to increase the draft, change the trim,
regulate the stability, or maintain stress
loads within acceptable operational
limits. Introduction of nonindigenous
invasive species, also known as aquatic
nuisance species (ANS), through ballast
water discharge is a global concern.
Ballast water discharge may contain
water-borne organisms taken up at the
last (or several recent) ballasting
locations as well as water-borne
organisms (especially eggs or larvae)
that were produced by adult individuals
in the ballast tank. Viable organisms
that are discharged and become
established in waters outside their
native range may have adverse effects
on native species and ecosystems,
infrastructure, human health,
socioeconomics, and other resources.
Current regulation of ballast water
(EPA’s ETV protocol; 2 USCG’s 33 CFR
part 151 subparts C and D) uses a live/
dead metric to measure the
concentration of living organisms in
ballast water after treatment by a
BWMS.
VIDA defines a BWMS as rendering
organisms ‘‘nonviable’’ if the organisms
are ‘‘permanently incapable of
reproduction following treatment.’’
(VIDA 2018, Clean Water Act section
312(p)(1)(U)). By adding ‘‘viability’’ of
organisms as a way of testing
compliance with ballast water discharge
standards, this change broadened how
compliance with ballast water discharge
1 132
Stat. 4192, Public Law 115–282, Dec. 4,
2018. See Sec. 903, Standards for Discharges
Incidental to Normal Operation of Vessels.
2 Generic Protocol for the Verification of Ballast
Water Treatment Technology, available in this
docket.
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67647
standards can be measured. In addition
to counting whether organisms in
ballast water discharge are alive, VIDA
allows the possibility for a BWMS to
meet EPA’s ballast water standard by
not counting organisms that are still
alive but not reproductively viable.
The definitions in Title 33 of the
United States Code section 1322 (33
U.S.C. 1322) of ‘‘live’’ and ‘‘living’’ as
applied to current Coast Guard BWMS
regulations do not address the instance
of organisms that are alive but incapable
of reproducing; thus, reproductively
nonviable organisms count the same as
viable living organisms. VIDA allows
the Coast Guard to consider type
approving BWMS that meet the
standard by counting organisms that are
alive but permanently nonviable the
same as dead organisms, and in doing
so to accept one or more viability test
methods for use in type approving
BWMS. EPA’s final rule setting
performance standards for ballast water
has not been published yet 3, but VIDA
stipulates that the Coast Guard consider
viability as applied to the Coast Guard’s
current ballast water standard as well as
EPA’s future ballast water standard
under VIDA.4
The Coast Guard has determined that
a PEIS is appropriate due to the wide
geographic applicability, the various
elements of uncertainty, and the
potential for significant impacts of the
Proposed Action. As such, we
encourage you to comment upon the
Proposed Action as a whole and provide
information specifically on these four
aspects: (1) the geographic areas that
should be focused upon; (2) the
uncertainties within the known viability
test methods; (3) the ways to evaluate
viability test methods; and (4) any
viability test methods themselves that
we may not have considered.
The Coast Guard’s Proposed Action
would have the potential to affect all
navigable waters of the United States,
including marine, estuarine, and
freshwater environments. The scope of
this action would include navigable
waterways of the United States where
discharge of ballast water is allowed,
and waterways and adjacent areas that
could be affected by such discharge. The
following areas of uncertainty have been
identified to date:
• No independently validated
viability testing method exists that can
accurately and precisely document the
3 EPA’s VIDA SNPRM was published October 18,
2023, 88 FR 71788. Federal Register: Vessel
Incidental Discharge National Standards of
Performance.
4 See Sec. 903 of VIDA (https://www.govinfo.gov/
content/pkg/PLAW-115publ282/pdf/PLAW115publ282.pdf) at 132 Stat. 4338.
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concentration of viable organisms in
ballast water discharged under typical
operational conditions throughout the
Action Area;
• Innumerable organisms in ballast
water discharge have not been identified
or cultured in laboratories; and
• No BWMS has been proven to
render all ANS discharged in ballast
water as permanently nonviable.
Currently, no specific viability test
method has been submitted to Coast
Guard for evaluation; therefore, this
PEIS will analyze the impacts of a
reasonable range of potential viability
testing methods that may be submitted
for Coast Guard review, based upon
testing methods gathered from the
applicable scientific literature.
The PEIS is intended to be broad
enough to represent the range of
viability testing methods known to the
Coast Guard at this time or likely to be
submitted for Coast Guard review and
acceptance. If a testing method that is
not covered in the PEIS is submitted to
the Coast Guard later, the Coast Guard
may determine that additional National
Environmental Policy Act (NEPA)
analysis is warranted.
This NOI briefly summarizes the
purpose and need for the Proposed
Action, the Proposed Action itself, and
the No Action Alternative. As required
by NEPA and its implementing
regulations (40 CFR 1502.3), a Federal
agency must prepare an EIS if it is
proposing a major Federal action with
the potential for significant impacts.
The NEPA process is designed to
identify and consider reasonably
foreseeable environmental effects of the
proposed action and all reasonable
alternatives, including the Proposed
Action, and to receive public input on
that analysis to inform the agency’s
decision.
Purpose and Need for the Proposed
Action
The Coast Guard’s Proposed Action is
to potentially accept one or more
viability testing method submitted to
the Coast Guard. Using best available
science, the Coast Guard would evaluate
each proposed method and accept
methods (if any) that can demonstrate
that ballast water discharge treated by a
U.S. type approved BWMS meets
applicable U.S. ballast water discharge
performance standards for viable
organisms.
To evaluate each submitted viability
testing method, the Coast Guard would
accept or reject a submitted Viability
Testing Method based upon best
available science, as described in the
Final Policy Letter, Type-Approval
Testing Protocols for Ballast Water
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Management Systems That Render
Organisms in Ballast Water Nonviable
(87 FR 16641, March 24, 2022).5 In
order to be accepted, a viability testing
method would have to accurately
quantify the concentration of viable
organisms in a targeted size class
remaining after the BWMS had either
removed, killed, or rendered
permanently nonviable other organisms
in the ballast water discharge. The
ultimate purpose of an accepted
viability testing method is to reduce the
probability that populations of ANS
released in ballast water discharge
become established in U.S. waters.
Proposed Action and Alternative
The Coast Guard has identified a
Proposed Action and a No Action
Alternative. Under the Proposed Action,
Coast Guard would consider, evaluate,
and accept one or more viability testing
methods submitted by a third party for
use in type approval of one or more
ballast water management systems. If a
viability test method is accepted and
used to type approve one or more ballast
water management systems, living
organisms that are deemed
‘‘permanently nonviable’’ would not
count in measuring living organisms
that are allowed to be discharged.
Typically, the No Action Alternative
assumes that current conditions
(without the Proposed Action) would be
maintained. However, VIDA stipulates
that existing EPA and Coast Guard
ballast water regulations will remain in
effect only until the EPA establishes
new performance standards and the
Coast Guard develops implementing
regulations, which must occur as soon
as practicable, but not later than 2 years
of EPA’s final rule.
Under the No Action Alternative, the
Coast Guard would consider, evaluate,
but not accept, any viability testing
method, and thus the Coast Guard
would continue to use the live/dead
method of measuring compliance with
the standard for type approval of
BWMS.
In the case of accepting a viability test
method, a ballast water discharge
sample containing 30 individuals per
mL (in the 10–50 micrometer (mm) size
class) would be deemed compliant with
the 10 individuals/mL discharge
performance standard if 20 of the 30
individuals were deemed ‘‘permanently
nonviable.’’ In this example, any
uncertainty associated with the
identification of an individual as
5 The final policy letter was effective February 28,
2022. A draft policy letter and request for comments
were published on July 31, 2019 (84 FR 37330). The
final policy letter is available in the docket.
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‘‘permanently nonviable’’ represents a
potential exceedance of the standard.
The U.S. Coast Guard currently uses the
3 methods described in EPA’s ETV
Protocol for US type approval of BWMS.
One of these methods uses staining, and
while that would still be used for live/
dead test methods, staining would not
be allowed under VIDA for viability test
methods.
Culture methods used to measure
viability in the three regulated bacteria
would continue: United States
Environmental Protection Agency
(USEPA) Method 1603 for E. coli;
modified version of USEPA Method
1106.1 for Enterococcus spp.; and a
DNA colony blot hybridization method
for V. cholera.
Under the No Action Alternative,
living organisms in the 10–50 mm size
class would continue to be detected
using manual epifluorescence
microscopy and staining; unstained but
motile organisms would be counted as
live. This test does not measure
reproductive viability; all living
organisms are presumed viable.
Under current testing methods for
heterotrophic organisms greater than or
equal to 50 mm, organisms are
determined to be living based on
motility analysis under magnification
(at least 10 seconds observation, with
prodding by the observer if necessary).
All organisms classified as living would
be assumed viable. Note that this test
does not measure actual reproductive
viability.
Proposed Action
VIDA explicitly requires that the
Coast Guard ‘‘take into consideration a
testing method that uses organism growout and MPN statistical analysis to
determine the concentration of
organisms in ballast water that are
capable of reproduction’’ 6 and prohibits
consideration of viability testing
methods that rely on staining methods
to measure the concentration of
organisms in the 10–50 mm size class.
Any accepted method will be used in
land-based or shipboard testing (or
both), so the method must be
appropriate for type approval tests.
Under the Proposed Action, the Coast
Guard would use a Decision Framework
to determine whether a proposed
viability testing method were acceptable
to use in type approving a BWMS. The
Decision Framework was designed to
meet the directive in VIDA that Coast
Guard use best available science (BAS)
to evaluate and accept any viability
6 132 Stat. 4338, Public Law 115–282, Dec. 4,
2018. See Sec. 903, Standards for Discharges
Incidental to Normal Operation of Vessels.
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testing methods that can measure
concentrations of organisms rendered
permanently incapable of reproduction
by the operation of a BWMS. All
available information, if relevant to the
intended output of a complete,
standardized viability testing method to
support BWMS type approval, will be
assessed pursuant to the Coast Guard
Decision Framework.
Table 2 lists viability testing methods
that the Coast Guard is aware of from
peer-reviewed published literature,
International Maritime Organization
(IMO) documents, public notices
prepared by proponents or developers,
or other indicators of potential use in
measuring concentrations of viable
organisms in ballast water discharge.
For instance, several methods
developed for or used in monitoring
pathogens in drinking water have
features that may make them suitable
(with or without modification) for
measuring viability of organisms in
ballast water discharge.
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Viability testing methods to be
evaluated in this PEIS represent three
stages of research and development for
use in testing treated ballast water
against U.S. or IMO D–2 standards: 7
1. Currently in use by Coast Guard or
IMO;
2. Suggested in the peer-reviewed
literature as potentially suitable; or
3. Under active research and
development, with early results
suggesting potential utility.
TABLE 1—POTENTIAL VIABILITY TESTING METHODS FOR COAST GUARD EVALUATION
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Viability test method
Target organisms
Brief description
Serial dilution culture most probable number (SDC–
MPN) assay 1.
10–50 μm size class (Autotrophs)
Most Probable Number Dilution Culture + Motility 1 ...
10–50 μm size (Heterotrophs) ......
Microscopy 2 (Standard, Epifluorescence, Variable
fluorescence, Chlorophyll a fluorescence, Raman
spectroscopy, Confocal Raman spectroscopy with
near infrared excitation).
10–50 μm and greater than or
equal to 50 μm size classes.
Motility and fluorescence assay 3 ................................
10–50 μm and greater than or
equal to 50 μm size classes.
Adenosine triphosphate (ATP) assay 3 .......................
10–50 μm size class .....................
7 IMO (2004) International convention for the
control and management of ships’ ballast water and
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SDC–MPN is a growth-based method that relies on
the use of serial dilutions to track population
growth over time, particularly in organisms with
defined growth characteristics, like microalgae.
The MPN culturing technique for protists was
adapted from food microbiology laboratories for
use in evaluating phytoplankton communities. It
uses a 14-day grow-out period to quantify reproductively viable phytoplankton.
The Heterotroph Method uses epifluorescence microscopy to identify and exclude from enumeration organisms that display the red fluorescence
of chlorophyll, a diagnostic of photosynthetic
autotrophs. The remaining organisms—those
without detectable chlorophyll—are defined as
heterotrophs. Heterotrophs that are observed to
move are classified as living.
Direct observation of ballast water samples under
magnification using stereo or compound microscopes. Specific types of microscopies use various light sources and sensors to enhance detection of cells and cell processes. Several indicative
tests using variable fluorescence are commercially available.
Automated system that counts motile and fluorescent organisms; indicative tests are available and
under development.
1st Generation methods measure active ATP in the
presence of luciferase enzyme. 2nd Generation
ATP test method measures all living bacteria,
culturable and non-culturable as well as
autotrophs and heterotrophs. ATP assays are
commercially available for indicative shipboard
commissioning testing using the IMO D–2 standard.
sediments. International Maritime Organization,
London.
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TABLE 1—POTENTIAL VIABILITY TESTING METHODS FOR COAST GUARD EVALUATION—Continued
Viability test method
Target organisms
Brief description
Polymerase chain reaction (PCR) 3 ............................
........................................................
mRNA 3 ........................................................................
bacteria (less than 10 μm size
class) and.
mRNA 3 ........................................................................
10–50 μm and greater than or
equal to 50 μm size classes.
Several kinds of molecular methods based on PCR
are used to detect live cells, including a molecular
activity test and viability PCR, Messenger ribonucleic acid (mRNA) is a type of single-stranded
RNA involved in protein synthesis. Because
mRNA is synthesized by living cells during the
process of transcription, the MVT measures
changes in concentration of mRNA as an indicator of the cell’s vitality.
Reverse transcription PCR allows the use of RNA
as a template to generate complementary
deoxyribonucleic acid (cDNA). Using the reverse
transcriptase enzyme, a single-stranded copy of
cDNA is generated. This can then be amplified by
a DNA polymerase, generating double-stranded
cDNA, feeding into a standard PCR-based amplification process.
Quantitative PCR (qPCR) is used to detect unwanted microbes (e.g., pathogens) and to identify
DNA sequences used to classify the organisms in
real time; qPCR methods generally use a fluorescent probe to quantify the DNA.
Viable bacteria can be identified through mRNA,
which exists only in molecularly active organisms.
This tool is used in conjunction with reverse
transcriptase PCR to reduce the time required to
culture bacteria in food products.
In principle, an mRNA primer can be created for
any organism for which adequate genetic Information is available, including chordates such as
tunicates.
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Notes:
1 Test may be used for IMO type approval of all BWMS technologies (BWM.2/Circ.61/Rev.1 Annex).
2 Various types of microscopies are currently used to identify living organisms in these size classes; reproductive viability cannot be determined
through microscopy alone.
3 Theoretically suitable for viability testing method; research and development are ongoing.
Summary of Expected Impacts
NEPA requires the identification and
evaluation of impacts to the human
environment that are reasonably
foreseeable because of the agency’s
Proposed Action. The analysis of
potential impacts is based on potential
changes in the concentrations of living
ANS released in ballast water discharge
in U.S. waters. Impacts of the Proposed
Action would be manifested through the
acceptance of a viability testing method
and its use by the Coast Guard to type
approve BWMS, and then the
subsequent discharge from those BWMS
into the Action Area.
The extent to which potential impacts
would affect a given resource in a
specific part of the Action Area would
be influenced by complex interrelated
variables independent of the Proposed
Action. For example, impacts of ANS to
U.S. ecosystems would be determined
by the specific viable organisms
released in specific locations under
specific conditions that favor
population establishment and growth;
all these variables are dynamic and
cannot be predicted quantitatively.
Nevertheless, the Coast Guard can
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assign relative probabilities of
occurrence of various impacts to
resources in selected locations in the
Action Area. Assumptions based on
historical and current data on ballast
water discharge volumes and locations,
presence of ANS in ballast tanks under
various conditions, known
physiological responses of organisms to
common BWMS, types of chemicals
released in ballast water discharge, and
other factors relevant to each resource
will be considered in the PEIS.
The potential impacts of the Proposed
Action could occur throughout the
Action Area. The set of human and
natural resources potentially affected by
the Proposed Action is known as the
affected environment. Resources that
have some reasonably foreseeable
chance of being affected by the
Proposed Action somewhere in the
Action Area, that may include
ecosystems, socioeconomic factors,
essential fish habitat, and managed
species, Endangered Species Act-listed
species, marine protected areas, water
quality, air quality, cultural resources,
migratory birds, human health, and the
Coastal Zone Management Act.
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Anticipated Permits and Authorizations
The Coast Guard will comply with all
applicable Federal, State, and local
laws. This includes, but is not limited
to, the following:
• The Coastal Zone Management Act
(16 U.S.C. 1451 et seq.)
• The Marine Mammal Protection Act
(16 U.S.C 1361 et seq.)
• The Endangered Species Act (16
U.S.C. 1531 et seq.)
• Clean Water Act (33 U.S.C. 1251, et
seq.)
• The National Historic Preservation
Act (16 U.S.C. 470, et seq.)
• Clean Air Act (42 U.S.C. 7401, et seq.)
In addition, Coast Guard will
complete Consultation with all affected
Federally Recognized Tribes on a
Government-to-Government basis in
accordance with Executive Order 13175
(Consultation and Coordination with
Indian Tribal Governments).
Schedule for the Decision-Making
Process
Following the scoping period
announced in this NOI, and after
consideration of all comments received
during the 45-day scoping period, the
E:\FR\FM\21AUN1.SGM
21AUN1
Federal Register / Vol. 89, No. 162 / Wednesday, August 21, 2024 / Notices
lotter on DSK11XQN23PROD with NOTICES1
Coast Guard will prepare a draft PEIS
for the Proposed Action to accept one or
more viability testing methods for use in
type approval of BWMSs. Once the draft
PEIS is completed, it will be made
available for a 45-day public review and
comment period.
The Coast Guard will announce the
availability of the draft PEIS in the
Federal Register and other media
outlets. The Coast Guard expects the
draft PEIS will be available for public
review and comment in 2024. In
meeting the Council on Environmental
Quality (CEQ) regulations generally
requiring EISs to be completed within 2
years, the Coast Guard anticipates the
final PEIS would be available in 2026.
The final PEIS will respond to all
comments received on the draft PEIS
within the draft PEIS comment period.
And we will publish a notice of
availability in the Federal Register
when we issue the PEIS. Should new
information become available after the
completion of the draft or final PEIS,
supplemental NEPA documentation
may be prepared in support of new
information or changes in the Proposed
Action considered under the PEIS.
Public Scoping Process
This NOI initiates the scoping
process, which guides development of
the PEIS. The Coast Guard is seeking
comments on the reasonably foreseeable
environmental impacts that may result
from the Proposed Action, accepting
one or more viability test methods that
would ultimately be used for type
approval of BWMS. The Coast Guard is
also seeking input on relevant
information, studies, or analyses of any
kind concerning impacts potentially
affecting the quality of human health or
the environment because of the
Proposed Action and alternatives.
NEPA requires Federal agencies to
consider environmental impacts that
may result from a Proposed Action, to
inform the public of potential impacts
and alternatives, and to facilitate public
involvement in the assessment process.
The PEIS will include, among other
topics, discussions of the purpose and
need for the Proposed Action, a
description of alternatives, a description
of the affected environment, and an
evaluation of the environmental impact
of the Proposed Action and alternatives.
The Coast Guard intends to follow the
CEQ regulations (40 CFR 1500 et. seq.),
Department of Homeland Security
(DHS) Directive Number 023–01, Rev.
01, and Instruction 023–001–01, Rev.
01; and Coast Guard Commandant
Instruction (COMDTINST) 5090.1, U.S.
Coast Guard Environmental Planning
Policy, by scoping through public
VerDate Sep<11>2014
17:17 Aug 20, 2024
Jkt 262001
comments. Scoping, which is integral to
the process for implementing NEPA,
provides a process to ensure that (1)
issues are identified early and properly
studied; (2) issues of little significance
do not consume substantial time and
effort; (3) the draft PEIS is thorough and
balanced; and (4) delays caused by an
inadequate PEIS are avoided.
Scope consists of the range and
breadth of actions, alternatives, and
effects to considered in an
environmental impact statement or
environmental assessment. The scoping
process begins with publication of this
NOI. The Coast Guard seeks to do the
following during the scoping process:
• Invite the participation of Federal,
State, and local agencies, any affected
Federally Recognized Tribes, and other
interested persons;
• Consult with affected Federally
Recognized Tribes on a Government-toGovernment basis in accordance with
Executive Order 13175 and other
policies. Concerns of Federally
Recognized Tribes, including potential
impacts on Treaty rights, Indian trust
assets, and cultural resources, will be
given appropriate consideration;
• Determine the scope and the issues
to be analyzed in depth in the PEIS;
• Identify any related environmental
assessments or environmental impact
statements that are not part of the PEIS;
and,
• Identify other relevant
environmental review and consultation
requirements, such as CZMA
consistency evaluations, and threatened
and endangered species and habitat
impacts.
In accordance with the U.S. Coast
Guard Environmental Planning
Procedures,8 the Coast Guard will reach
out to relevant agencies with
jurisdiction by law or special expertise
with respect to environmental issues in
the project area.
Pursuant to the CEQ regulations,
Coast Guard invites public participation
in the NEPA process. This NOI requests
public participation in the scoping
process, establishes a public comment
period, and provides information on
how to participate.
The public will be provided with an
opportunity to review and comment on
the draft PEIS. Comments received
during the draft PEIS review period will
be available in the public docket (where
indicated under the Public Participation
and Request for Comments portion of
this notice) and made available in the
final PEIS.
8 Environmental Planning COMDTINST 5090.1
(series).
PO 00000
Frm 00065
Fmt 4703
Sfmt 4703
67651
The 45-day public scoping period
begins August 21, 2024 and ends
October 7, 2024. Comments and related
material submitted to the online docket
via https://www.regulations.gov/ must
be received by the Coast Guard on or
before October 7, 2024. Comments may
also be provided at one of the public
meetings referenced in the Public
Participation and Request for Comments
portion of the SUPPLEMENTARY
INFORMATION section of this notice.
We request your comments on
environmental concerns that you may
have related to the PEIS. This includes
suggesting analyses and methodologies
for use in the PEIS or possible sources
of data or information not included in
the draft PEIS. Your comments will be
considered in preparing the final PEIS.
This notice is issued under authority
of 42 U.S.C. 4332.
Dated: August 6, 2024.
W.R. Arguin,
Rear Admiral, U.S. Coast Guard, Assistant
Commandant for Prevention Policy.
[FR Doc. 2024–18597 Filed 8–20–24; 8:45 am]
BILLING CODE 9110–04–P
DEPARTMENT OF THE INTERIOR
Bureau of Indian Affairs
[245A2100DD/AAKC001030/
A0A501010.999900; OMB Control Number
1076–0149, 1076–0152, 1076–0158, 1076–
0172]
Agency Information Collection
Activities; Submission to the Office of
Management and Budget for Review
and Approval; Request for Comment
on 25 CFR 290–293 Expirations Under
the Paperwork Reduction Act
Bureau of Indian Affairs,
Interior.
ACTION: Notice of information collection;
request for comment.
AGENCY:
In accordance with the
Paperwork Reduction Act of 1995, we,
Indian Affairs, are proposing to renew
four (4) information collections. We are
seeking comments from the public, and
other Federal agencies, as part of our
continuing effort to minimize burdens
and enhance the quality, utility, and
clarity of the information to be
collected.
SUMMARY:
Interested persons are invited to
submit comments on or before
September 20, 2024.
ADDRESSES: Written comments and
recommendations for each proposed
information collection request (ICR)
should be sent within 30 days of
publication of this notice to the Office
DATES:
E:\FR\FM\21AUN1.SGM
21AUN1
]]>Agencies
[Federal Register Volume 89, Number 162 (Wednesday, August 21, 2024)]
[Notices]
[Pages 67646-67651]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-18597]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HOMELAND SECURITY
Coast Guard
[Docket No. USCG-2024-0501]
Consideration for Acceptance of One or More Viability Testing
Methods for Type Approval of Ballast Water Management Systems
AGENCY: Coast Guard, DHS.
ACTION: Notice of intent to prepare a Programmatic Environmental Impact
Statement; notice of virtual scoping meetings; and request for
comments.
-----------------------------------------------------------------------
SUMMARY: The Coast Guard, as the lead agency, announces its intent to
prepare the Viability Testing Method Consideration for Acceptance
Programmatic Environmental Impact Statement. Through this document, we
will evaluate the potential environmental impact of the Coast Guard's
Proposed Action to use the best available science to evaluate one or
more viability testing methods submitted for consideration. Through
this document, we will also evaluate, and potentially accept, methods
that demonstrate that ballast water discharge meets U.S. ballast water
discharge performance standards currently under development by the
Environmental Protection Agency.
DATES: Comments must be submitted orally at one of the public meetings
or in writing the online docket via https://www.regulations.gov on or
before October 7, 2024. Virtual public meetings regarding this notice
of intent will be held Thursday, September 5, 2024, at 12 p.m. EST,
Tuesday, September 10, 2024 at 4 p.m. EST, and Wednesday, September 11,
2024 at 7 p.m. EST.
ADDRESSES: You may submit comments identified by docket number USCG-
2024-0501 using the Federal Decision-Making Portal at https://www.regulations.gov. See the ``Public Participation and Request for
Comments'' portion of the SUPPLEMENTARY INFORMATION section for further
instructions on submitting comments.
FOR FURTHER INFORMATION CONTACT: For information about this document,
call or email Commander Andrew Murphy, Coast Guard; telephone 202-372-
1430; email [email protected].
SUPPLEMENTARY INFORMATION:
Public Participation and Request for Comments
We encourage you to submit comments and related material on
preliminary alternatives to help the Coast Guard identify reasonable
alternatives. We will consider all submissions and may adjust our final
action based on your comments. If you submit a comment, please include
the docket number for this notice, indicate the specific item 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-2024-0501 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 your material cannot be submitted using https://www.regulations.gov, contact the person in the FOR FURTHER INFORMATION
CONTACT section of this document for alternate instructions.
Viewing material in docket. Public comments will be placed in our
online docket and can be viewed by following instructions on the
https://www.regulations.gov Frequently Asked Questions web page. We
review all comments received, but 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
in response to this document, see DHS's eRulemaking System of Records
notice (85 FR 14226, March 11, 2020).
Public Meeting
We plan to hold three virtual public scoping meetings to solicit
feedback. At these meetings, the Coast Guard will present an overview
of the Proposed Action and the environmental review process, followed
by a period of listening to oral comments from the public. The Coast
Guard will record all oral comments and respond to them in the Draft
PEIS. The public meetings will be held virtually in Microsoft Teams at
the following dates below. The public meetings can be accessed by
either Microsoft Teams or by telephone.
Thursday, September 5, 2024
12:00 p.m. EST (4:00 p.m. UTC)
Meeting Link: https://tinyurl.com/CGVIDAVT1
Meeting ID: 242 571 871 890
Passcode: DD7bEW
Phone-in: +1 202-660-1181
Phone conference ID: 925 558 1#
Tuesday, September 10, 2024
[[Page 67647]]
4:00 p.m. EST (8:00 p.m. UTC)
Meeting Link: https://tinyurl.com/CGVIDAVT2
Meeting ID: 294 512 529 402
Passcode: 8wzmy4
Phone-in: +1 202-660-1181
Phone conference ID: 567 920 777#
Wednesday, September 11, 2024
7:00 p.m. EST (11:00 p.m. UTC)
Meeting Link: https://tinyurl.com/CGVIDAVT3
Meeting ID: 265 269 415 521
Passcode: jhEUSk
Phone-in: +1 202-660-1181
Phone conference ID: 125 105 712#
For information on facilities or services for individuals with
disabilities or to request special assistance at the public meeting,
contact the person named in the FOR FURTHER INFORMATION CONTACT
section, above.
Abbreviations
ANS Aquatic nuisance species
ATP Adenosine triphosphate
BWMS Ballast Water Management System
CDNA Complementary DNA
CEQ Council on Environmental Quality
CMFDA 5-chloromethylfluorescein diacetate
CFR Code of Federal Regulations
DHS Department of Homeland Security
EIS Environmental Impact Statement
EPA Environmental Protection Agency
ETV Environmental Technology Verification
FDA Fluorescein diacetate
IMO International Maritime Organization
[micro]m Micrometer
MPN Most probable number
NEPA National Environmental Policy Act
NOI Notice of Intent
PCR Polymerase chain reaction
PEIS Programmatic Environmental Impact Statement
qPCR Quantitative polymerase chain reaction
SDC-MPN Serial dilution culture most probable number
U.S.C. United States Code
USEPA United States Environmental Protection Agency
VIDA Vessel Incidental Discharge Act
Background
Currently, Coast Guard type approval is granted for ballast water
management systems (BWMSs) that meet the live/dead standard under
protocols described in title 46 of the Code of Federal Regulations
(CFR) and the Environmental Protection Agency's (EPA's) Environmental
Technology Verification (ETV) Program (EPA 2010), which include the use
of cell tracing stains (such as fluorescein diacetate or (FDA) 5-
chloromethylfluorescein diacetate (CMFDA), and do not include the use
of viability tests. The Vessel Incidental Discharge Act (VIDA) of 2018
\1\ allows the Coast Guard to consider the use of viability tests for
the type approval of BWMS and directs the Coast Guard to not consider
methods for viability that rely on staining to measure the
concentrations of organisms that are between (or equivalent to) 10 and
50 micrometers ([micro]m).
---------------------------------------------------------------------------
\1\ 132 Stat. 4192, Public Law 115-282, Dec. 4, 2018. See Sec.
903, Standards for Discharges Incidental to Normal Operation of
Vessels.
---------------------------------------------------------------------------
This Notice of Intent (NOI) is intended to solicit feedback on the
scope of the Programmatic Environmental Impact Statement (PEIS). The
Coast Guard intends to host three virtual scoping meetings to provide
additional information to the public and to solicit input on potential
issues, concerns, and reasonable alternatives that should be considered
in the PEIS.
Discussion
Congress, through enacting VIDA required the Coast Guard to
consider adding ``viability'' of organisms as a way of testing
compliance with ballast water discharge standards.
Ballast water is taken on by a vessel to increase the draft, change
the trim, regulate the stability, or maintain stress loads within
acceptable operational limits. Introduction of nonindigenous invasive
species, also known as aquatic nuisance species (ANS), through ballast
water discharge is a global concern. Ballast water discharge may
contain water-borne organisms taken up at the last (or several recent)
ballasting locations as well as water-borne organisms (especially eggs
or larvae) that were produced by adult individuals in the ballast tank.
Viable organisms that are discharged and become established in waters
outside their native range may have adverse effects on native species
and ecosystems, infrastructure, human health, socioeconomics, and other
resources. Current regulation of ballast water (EPA's ETV protocol; \2\
USCG's 33 CFR part 151 subparts C and D) uses a live/dead metric to
measure the concentration of living organisms in ballast water after
treatment by a BWMS.
---------------------------------------------------------------------------
\2\ Generic Protocol for the Verification of Ballast Water
Treatment Technology, available in this docket.
---------------------------------------------------------------------------
VIDA defines a BWMS as rendering organisms ``nonviable'' if the
organisms are ``permanently incapable of reproduction following
treatment.'' (VIDA 2018, Clean Water Act section 312(p)(1)(U)). By
adding ``viability'' of organisms as a way of testing compliance with
ballast water discharge standards, this change broadened how compliance
with ballast water discharge standards can be measured. In addition to
counting whether organisms in ballast water discharge are alive, VIDA
allows the possibility for a BWMS to meet EPA's ballast water standard
by not counting organisms that are still alive but not reproductively
viable.
The definitions in Title 33 of the United States Code section 1322
(33 U.S.C. 1322) of ``live'' and ``living'' as applied to current Coast
Guard BWMS regulations do not address the instance of organisms that
are alive but incapable of reproducing; thus, reproductively nonviable
organisms count the same as viable living organisms. VIDA allows the
Coast Guard to consider type approving BWMS that meet the standard by
counting organisms that are alive but permanently nonviable the same as
dead organisms, and in doing so to accept one or more viability test
methods for use in type approving BWMS. EPA's final rule setting
performance standards for ballast water has not been published yet \3\,
but VIDA stipulates that the Coast Guard consider viability as applied
to the Coast Guard's current ballast water standard as well as EPA's
future ballast water standard under VIDA.\4\
---------------------------------------------------------------------------
\3\ EPA's VIDA SNPRM was published October 18, 2023, 88 FR
71788. Federal Register: Vessel Incidental Discharge National
Standards of Performance.
\4\ See Sec. 903 of VIDA (https://www.govinfo.gov/content/pkg/PLAW-115publ282/pdf/PLAW-115publ282.pdf) at 132 Stat. 4338.
---------------------------------------------------------------------------
The Coast Guard has determined that a PEIS is appropriate due to
the wide geographic applicability, the various elements of uncertainty,
and the potential for significant impacts of the Proposed Action. As
such, we encourage you to comment upon the Proposed Action as a whole
and provide information specifically on these four aspects: (1) the
geographic areas that should be focused upon; (2) the uncertainties
within the known viability test methods; (3) the ways to evaluate
viability test methods; and (4) any viability test methods themselves
that we may not have considered.
The Coast Guard's Proposed Action would have the potential to
affect all navigable waters of the United States, including marine,
estuarine, and freshwater environments. The scope of this action would
include navigable waterways of the United States where discharge of
ballast water is allowed, and waterways and adjacent areas that could
be affected by such discharge. The following areas of uncertainty have
been identified to date:
No independently validated viability testing method exists
that can accurately and precisely document the
[[Page 67648]]
concentration of viable organisms in ballast water discharged under
typical operational conditions throughout the Action Area;
Innumerable organisms in ballast water discharge have not
been identified or cultured in laboratories; and
No BWMS has been proven to render all ANS discharged in
ballast water as permanently nonviable.
Currently, no specific viability test method has been submitted to
Coast Guard for evaluation; therefore, this PEIS will analyze the
impacts of a reasonable range of potential viability testing methods
that may be submitted for Coast Guard review, based upon testing
methods gathered from the applicable scientific literature.
The PEIS is intended to be broad enough to represent the range of
viability testing methods known to the Coast Guard at this time or
likely to be submitted for Coast Guard review and acceptance. If a
testing method that is not covered in the PEIS is submitted to the
Coast Guard later, the Coast Guard may determine that additional
National Environmental Policy Act (NEPA) analysis is warranted.
This NOI briefly summarizes the purpose and need for the Proposed
Action, the Proposed Action itself, and the No Action Alternative. As
required by NEPA and its implementing regulations (40 CFR 1502.3), a
Federal agency must prepare an EIS if it is proposing a major Federal
action with the potential for significant impacts. The NEPA process is
designed to identify and consider reasonably foreseeable environmental
effects of the proposed action and all reasonable alternatives,
including the Proposed Action, and to receive public input on that
analysis to inform the agency's decision.
Purpose and Need for the Proposed Action
The Coast Guard's Proposed Action is to potentially accept one or
more viability testing method submitted to the Coast Guard. Using best
available science, the Coast Guard would evaluate each proposed method
and accept methods (if any) that can demonstrate that ballast water
discharge treated by a U.S. type approved BWMS meets applicable U.S.
ballast water discharge performance standards for viable organisms.
To evaluate each submitted viability testing method, the Coast
Guard would accept or reject a submitted Viability Testing Method based
upon best available science, as described in the Final Policy Letter,
Type-Approval Testing Protocols for Ballast Water Management Systems
That Render Organisms in Ballast Water Nonviable (87 FR 16641, March
24, 2022).\5\ In order to be accepted, a viability testing method would
have to accurately quantify the concentration of viable organisms in a
targeted size class remaining after the BWMS had either removed,
killed, or rendered permanently nonviable other organisms in the
ballast water discharge. The ultimate purpose of an accepted viability
testing method is to reduce the probability that populations of ANS
released in ballast water discharge become established in U.S. waters.
---------------------------------------------------------------------------
\5\ The final policy letter was effective February 28, 2022. A
draft policy letter and request for comments were published on July
31, 2019 (84 FR 37330). The final policy letter is available in the
docket.
---------------------------------------------------------------------------
Proposed Action and Alternative
The Coast Guard has identified a Proposed Action and a No Action
Alternative. Under the Proposed Action, Coast Guard would consider,
evaluate, and accept one or more viability testing methods submitted by
a third party for use in type approval of one or more ballast water
management systems. If a viability test method is accepted and used to
type approve one or more ballast water management systems, living
organisms that are deemed ``permanently nonviable'' would not count in
measuring living organisms that are allowed to be discharged.
Typically, the No Action Alternative assumes that current
conditions (without the Proposed Action) would be maintained. However,
VIDA stipulates that existing EPA and Coast Guard ballast water
regulations will remain in effect only until the EPA establishes new
performance standards and the Coast Guard develops implementing
regulations, which must occur as soon as practicable, but not later
than 2 years of EPA's final rule.
Under the No Action Alternative, the Coast Guard would consider,
evaluate, but not accept, any viability testing method, and thus the
Coast Guard would continue to use the live/dead method of measuring
compliance with the standard for type approval of BWMS.
In the case of accepting a viability test method, a ballast water
discharge sample containing 30 individuals per mL (in the 10-50
micrometer ([micro]m) size class) would be deemed compliant with the 10
individuals/mL discharge performance standard if 20 of the 30
individuals were deemed ``permanently nonviable.'' In this example, any
uncertainty associated with the identification of an individual as
``permanently nonviable'' represents a potential exceedance of the
standard. The U.S. Coast Guard currently uses the 3 methods described
in EPA's ETV Protocol for US type approval of BWMS. One of these
methods uses staining, and while that would still be used for live/dead
test methods, staining would not be allowed under VIDA for viability
test methods.
Culture methods used to measure viability in the three regulated
bacteria would continue: United States Environmental Protection Agency
(USEPA) Method 1603 for E. coli; modified version of USEPA Method
1106.1 for Enterococcus spp.; and a DNA colony blot hybridization
method for V. cholera.
Under the No Action Alternative, living organisms in the 10-50
[micro]m size class would continue to be detected using manual
epifluorescence microscopy and staining; unstained but motile organisms
would be counted as live. This test does not measure reproductive
viability; all living organisms are presumed viable.
Under current testing methods for heterotrophic organisms greater
than or equal to 50 [micro]m, organisms are determined to be living
based on motility analysis under magnification (at least 10 seconds
observation, with prodding by the observer if necessary). All organisms
classified as living would be assumed viable. Note that this test does
not measure actual reproductive viability.
Proposed Action
VIDA explicitly requires that the Coast Guard ``take into
consideration a testing method that uses organism grow-out and MPN
statistical analysis to determine the concentration of organisms in
ballast water that are capable of reproduction'' \6\ and prohibits
consideration of viability testing methods that rely on staining
methods to measure the concentration of organisms in the 10-50 [micro]m
size class. Any accepted method will be used in land-based or shipboard
testing (or both), so the method must be appropriate for type approval
tests.
---------------------------------------------------------------------------
\6\ 132 Stat. 4338, Public Law 115-282, Dec. 4, 2018. See Sec.
903, Standards for Discharges Incidental to Normal Operation of
Vessels.
---------------------------------------------------------------------------
Under the Proposed Action, the Coast Guard would use a Decision
Framework to determine whether a proposed viability testing method were
acceptable to use in type approving a BWMS. The Decision Framework was
designed to meet the directive in VIDA that Coast Guard use best
available science (BAS) to evaluate and accept any viability
[[Page 67649]]
testing methods that can measure concentrations of organisms rendered
permanently incapable of reproduction by the operation of a BWMS. All
available information, if relevant to the intended output of a
complete, standardized viability testing method to support BWMS type
approval, will be assessed pursuant to the Coast Guard Decision
Framework.
Table 2 lists viability testing methods that the Coast Guard is
aware of from peer-reviewed published literature, International
Maritime Organization (IMO) documents, public notices prepared by
proponents or developers, or other indicators of potential use in
measuring concentrations of viable organisms in ballast water
discharge. For instance, several methods developed for or used in
monitoring pathogens in drinking water have features that may make them
suitable (with or without modification) for measuring viability of
organisms in ballast water discharge.
Viability testing methods to be evaluated in this PEIS represent
three stages of research and development for use in testing treated
ballast water against U.S. or IMO D-2 standards: \7\
---------------------------------------------------------------------------
\7\ IMO (2004) International convention for the control and
management of ships' ballast water and sediments. International
Maritime Organization, London.
---------------------------------------------------------------------------
1. Currently in use by Coast Guard or IMO;
2. Suggested in the peer-reviewed literature as potentially
suitable; or
3. Under active research and development, with early results
suggesting potential utility.
Table 1--Potential Viability Testing Methods for Coast Guard Evaluation
------------------------------------------------------------------------
Viability test method Target organisms Brief description
------------------------------------------------------------------------
Serial dilution culture most 10-50 [micro]m SDC-MPN is a
probable number (SDC-MPN) assay size class growth-based
\1\. (Autotrophs). method that
relies on the use
of serial
dilutions to
track population
growth over time,
particularly in
organisms with
defined growth
characteristics,
like microalgae.
The MPN culturing
technique for
protists was
adapted from food
microbiology
laboratories for
use in evaluating
phytoplankton
communities. It
uses a 14-day
grow-out period
to quantify
reproductively
viable
phytoplankton.
Most Probable Number Dilution 10-50 [micro]m The Heterotroph
Culture + Motility \1\. size Method uses
(Heterotrophs). epifluorescence
microscopy to
identify and
exclude from
enumeration
organisms that
display the red
fluorescence of
chlorophyll, a
diagnostic of
photosynthetic
autotrophs. The
remaining
organisms--those
without
detectable
chlorophyll--are
defined as
heterotrophs.
Heterotrophs that
are observed to
move are
classified as
living.
Microscopy \2\ (Standard, 10-50 [micro]m and Direct observation
Epifluorescence, Variable greater than or of ballast water
fluorescence, Chlorophyll a equal to 50 samples under
fluorescence, Raman [micro]m size magnification
spectroscopy, Confocal Raman classes. using stereo or
spectroscopy with near infrared compound
excitation). microscopes.
Specific types of
microscopies use
various light
sources and
sensors to
enhance detection
of cells and cell
processes.
Several
indicative tests
using variable
fluorescence are
commercially
available.
Motility and fluorescence assay 10-50 [micro]m and Automated system
\3\. greater than or that counts
equal to 50 motile and
[micro]m size fluorescent
classes. organisms;
indicative tests
are available and
under
development.
Adenosine triphosphate (ATP) 10-50 [micro]m 1st Generation
assay \3\. size class. methods measure
active ATP in the
presence of
luciferase
enzyme. 2nd
Generation ATP
test method
measures all
living bacteria,
culturable and
non-culturable as
well as
autotrophs and
heterotrophs. ATP
assays are
commercially
available for
indicative
shipboard
commissioning
testing using the
IMO D-2 standard.
[[Page 67650]]
Polymerase chain reaction (PCR) .................. Several kinds of
\3\. molecular methods
based on PCR are
used to detect
live cells,
including a
molecular
activity test and
viability PCR,
Messenger
ribonucleic acid
(mRNA) is a type
of single-
stranded RNA
involved in
protein
synthesis.
Because mRNA is
synthesized by
living cells
during the
process of
transcription,
the MVT measures
changes in
concentration of
mRNA as an
indicator of the
cell's vitality.
Reverse
transcription PCR
allows the use of
RNA as a template
to generate
complementary
deoxyribonucleic
acid (cDNA).
Using the reverse
transcriptase
enzyme, a single-
stranded copy of
cDNA is
generated. This
can then be
amplified by a
DNA polymerase,
generating double-
stranded cDNA,
feeding into a
standard PCR-
based
amplification
process.
Quantitative PCR
(qPCR) is used to
detect unwanted
microbes (e.g.,
pathogens) and to
identify DNA
sequences used to
classify the
organisms in real
time; qPCR
methods generally
use a fluorescent
probe to quantify
the DNA.
mRNA \3\........................ bacteria (less Viable bacteria
than 10 [micro]m can be identified
size class) and. through mRNA,
which exists only
in molecularly
active organisms.
This tool is used
in conjunction
with reverse
transcriptase PCR
to reduce the
time required to
culture bacteria
in food products.
mRNA \3\........................ 10-50 [micro]m and In principle, an
greater than or mRNA primer can
equal to 50 be created for
[micro]m size any organism for
classes. which adequate
genetic
Information is
available,
including
chordates such as
tunicates.
------------------------------------------------------------------------
Notes:
\1\ Test may be used for IMO type approval of all BWMS technologies
(BWM.2/Circ.61/Rev.1 Annex).
\2\ Various types of microscopies are currently used to identify living
organisms in these size classes; reproductive viability cannot be
determined through microscopy alone.
\3\ Theoretically suitable for viability testing method; research and
development are ongoing.
Summary of Expected Impacts
NEPA requires the identification and evaluation of impacts to the
human environment that are reasonably foreseeable because of the
agency's Proposed Action. The analysis of potential impacts is based on
potential changes in the concentrations of living ANS released in
ballast water discharge in U.S. waters. Impacts of the Proposed Action
would be manifested through the acceptance of a viability testing
method and its use by the Coast Guard to type approve BWMS, and then
the subsequent discharge from those BWMS into the Action Area.
The extent to which potential impacts would affect a given resource
in a specific part of the Action Area would be influenced by complex
interrelated variables independent of the Proposed Action. For example,
impacts of ANS to U.S. ecosystems would be determined by the specific
viable organisms released in specific locations under specific
conditions that favor population establishment and growth; all these
variables are dynamic and cannot be predicted quantitatively.
Nevertheless, the Coast Guard can assign relative probabilities of
occurrence of various impacts to resources in selected locations in the
Action Area. Assumptions based on historical and current data on
ballast water discharge volumes and locations, presence of ANS in
ballast tanks under various conditions, known physiological responses
of organisms to common BWMS, types of chemicals released in ballast
water discharge, and other factors relevant to each resource will be
considered in the PEIS.
The potential impacts of the Proposed Action could occur throughout
the Action Area. The set of human and natural resources potentially
affected by the Proposed Action is known as the affected environment.
Resources that have some reasonably foreseeable chance of being
affected by the Proposed Action somewhere in the Action Area, that may
include ecosystems, socioeconomic factors, essential fish habitat, and
managed species, Endangered Species Act-listed species, marine
protected areas, water quality, air quality, cultural resources,
migratory birds, human health, and the Coastal Zone Management Act.
Anticipated Permits and Authorizations
The Coast Guard will comply with all applicable Federal, State, and
local laws. This includes, but is not limited to, the following:
The Coastal Zone Management Act (16 U.S.C. 1451 et seq.)
The Marine Mammal Protection Act (16 U.S.C 1361 et seq.)
The Endangered Species Act (16 U.S.C. 1531 et seq.)
Clean Water Act (33 U.S.C. 1251, et seq.)
The National Historic Preservation Act (16 U.S.C. 470, et
seq.)
Clean Air Act (42 U.S.C. 7401, et seq.)
In addition, Coast Guard will complete Consultation with all
affected Federally Recognized Tribes on a Government-to-Government
basis in accordance with Executive Order 13175 (Consultation and
Coordination with Indian Tribal Governments).
Schedule for the Decision-Making Process
Following the scoping period announced in this NOI, and after
consideration of all comments received during the 45-day scoping
period, the
[[Page 67651]]
Coast Guard will prepare a draft PEIS for the Proposed Action to accept
one or more viability testing methods for use in type approval of
BWMSs. Once the draft PEIS is completed, it will be made available for
a 45-day public review and comment period.
The Coast Guard will announce the availability of the draft PEIS in
the Federal Register and other media outlets. The Coast Guard expects
the draft PEIS will be available for public review and comment in 2024.
In meeting the Council on Environmental Quality (CEQ) regulations
generally requiring EISs to be completed within 2 years, the Coast
Guard anticipates the final PEIS would be available in 2026. The final
PEIS will respond to all comments received on the draft PEIS within the
draft PEIS comment period. And we will publish a notice of availability
in the Federal Register when we issue the PEIS. Should new information
become available after the completion of the draft or final PEIS,
supplemental NEPA documentation may be prepared in support of new
information or changes in the Proposed Action considered under the
PEIS.
Public Scoping Process
This NOI initiates the scoping process, which guides development of
the PEIS. The Coast Guard is seeking comments on the reasonably
foreseeable environmental impacts that may result from the Proposed
Action, accepting one or more viability test methods that would
ultimately be used for type approval of BWMS. The Coast Guard is also
seeking input on relevant information, studies, or analyses of any kind
concerning impacts potentially affecting the quality of human health or
the environment because of the Proposed Action and alternatives.
NEPA requires Federal agencies to consider environmental impacts
that may result from a Proposed Action, to inform the public of
potential impacts and alternatives, and to facilitate public
involvement in the assessment process. The PEIS will include, among
other topics, discussions of the purpose and need for the Proposed
Action, a description of alternatives, a description of the affected
environment, and an evaluation of the environmental impact of the
Proposed Action and alternatives.
The Coast Guard intends to follow the CEQ regulations (40 CFR 1500
et. seq.), Department of Homeland Security (DHS) Directive Number 023-
01, Rev. 01, and Instruction 023-001-01, Rev. 01; and Coast Guard
Commandant Instruction (COMDTINST) 5090.1, U.S. Coast Guard
Environmental Planning Policy, by scoping through public comments.
Scoping, which is integral to the process for implementing NEPA,
provides a process to ensure that (1) issues are identified early and
properly studied; (2) issues of little significance do not consume
substantial time and effort; (3) the draft PEIS is thorough and
balanced; and (4) delays caused by an inadequate PEIS are avoided.
Scope consists of the range and breadth of actions, alternatives,
and effects to considered in an environmental impact statement or
environmental assessment. The scoping process begins with publication
of this NOI. The Coast Guard seeks to do the following during the
scoping process:
Invite the participation of Federal, State, and local
agencies, any affected Federally Recognized Tribes, and other
interested persons;
Consult with affected Federally Recognized Tribes on a
Government-to-Government basis in accordance with Executive Order 13175
and other policies. Concerns of Federally Recognized Tribes, including
potential impacts on Treaty rights, Indian trust assets, and cultural
resources, will be given appropriate consideration;
Determine the scope and the issues to be analyzed in depth
in the PEIS;
Identify any related environmental assessments or
environmental impact statements that are not part of the PEIS; and,
Identify other relevant environmental review and
consultation requirements, such as CZMA consistency evaluations, and
threatened and endangered species and habitat impacts.
In accordance with the U.S. Coast Guard Environmental Planning
Procedures,\8\ the Coast Guard will reach out to relevant agencies with
jurisdiction by law or special expertise with respect to environmental
issues in the project area.
---------------------------------------------------------------------------
\8\ Environmental Planning COMDTINST 5090.1 (series).
---------------------------------------------------------------------------
Pursuant to the CEQ regulations, Coast Guard invites public
participation in the NEPA process. This NOI requests public
participation in the scoping process, establishes a public comment
period, and provides information on how to participate.
The public will be provided with an opportunity to review and
comment on the draft PEIS. Comments received during the draft PEIS
review period will be available in the public docket (where indicated
under the Public Participation and Request for Comments portion of this
notice) and made available in the final PEIS.
The 45-day public scoping period begins August 21, 2024 and ends
October 7, 2024. Comments and related material submitted to the online
docket via https://www.regulations.gov/ must be received by the Coast
Guard on or before October 7, 2024. Comments may also be provided at
one of the public meetings referenced in the Public Participation and
Request for Comments portion of the SUPPLEMENTARY INFORMATION section
of this notice.
We request your comments on environmental concerns that you may
have related to the PEIS. This includes suggesting analyses and
methodologies for use in the PEIS or possible sources of data or
information not included in the draft PEIS. Your comments will be
considered in preparing the final PEIS.
This notice is issued under authority of 42 U.S.C. 4332.
Dated: August 6, 2024.
W.R. Arguin,
Rear Admiral, U.S. Coast Guard, Assistant Commandant for Prevention
Policy.
[FR Doc. 2024-18597 Filed 8-20-24; 8:45 am]
BILLING CODE 9110-04-P
