Rule2022-06201
Final Policy Letter Describing Type-Approval Testing Methods for Ballast Water Management Systems (BWMS) That Render Organisms Nonviable in Ballast Water
Primary source
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Published
March 24, 2022
Issuing agencies
Homeland Security DepartmentCoast Guard
Abstract
The Coast Guard announces the availability of the final policy letter that describes type-approval testing methods, and the acceptance process for such methods, for ballast water management systems (BWMS) that render organisms nonviable in ballast water. At this time, the Coast Guard does not accept any type-approval testing methods for ballast water management systems that render organisms in ballast water nonviable (meaning "permanently incapable of reproduction"). In consideration of public comments on the draft policy letter, this final policy letter establishes the mechanism for reviewing and integrating viability testing methods into the existing Coast Guard type-approval testing program. The Coast Guard invites submissions of viability testing methods in accordance with the policy letter at any time following publication. The Coast Guard will review any provided information responsive to the policy letter and enclosure. This final policy letter is subject to revision, in coordination with the Environmental Protection Agency, contingent on any Coast Guard determination that a viability testing method is acceptable.
Full Text
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<title>Federal Register, Volume 87 Issue 57 (Thursday, March 24, 2022)</title>
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[Federal Register Volume 87, Number 57 (Thursday, March 24, 2022)]
[Rules and Regulations]
[Pages 16641-16651]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-06201]
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DEPARTMENT OF HOMELAND SECURITY
Coast Guard
46 CFR Part 162
RIN 1625-ZA42
[Docket No. USCG-2019-0477]
Final Policy Letter Describing Type-Approval Testing Methods for
Ballast Water Management Systems (BWMS) That Render Organisms Nonviable
in Ballast Water
AGENCY: Coast Guard, DHS.
ACTION: Final policy; notification.
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SUMMARY: The Coast Guard announces the availability of the final policy
letter that describes type-approval testing methods, and the acceptance
process for such methods, for ballast water management systems (BWMS)
that render organisms nonviable in ballast water. At this time, the
Coast Guard does not accept any type-approval testing methods for
ballast water management systems that render organisms in ballast water
nonviable (meaning ``permanently incapable of reproduction''). In
consideration of public comments on the draft policy letter, this final
policy letter establishes the mechanism for reviewing and integrating
viability testing methods into the existing Coast Guard type-approval
testing program. The Coast Guard invites submissions of viability
testing methods in accordance with the policy letter at any time
following publication. The Coast Guard will review any provided
information responsive to the policy letter and enclosure. This final
policy letter is subject to revision, in coordination with the
Environmental Protection Agency, contingent on any Coast Guard
determination that a viability testing method is acceptable.
DATES: The final policy letter announced in this notification is issued
as of February 28, 2022.
ADDRESSES: To view the final policy letter, as well as comments
mentioned in this notice as being available in the docket, go to
<a href="https://www.regulations.gov">https://www.regulations.gov</a>, type ``USCG-2019-0477,'' and click
``Search.'' To see the final policy letter, click on this notice in the
search results, and then click ``View More Documents.'' To see
comments, click on the July 2019 Draft Policy Letter notice in the
search results, and then click ``View Related Comments.''
FOR FURTHER INFORMATION CONTACT: Mr. Matthew Reudelhuber, Environmental
Standards Division, 202-372-1432.
SUPPLEMENTARY INFORMATION:
Table of Contents for Preamble
I. Abbreviations
II. Background
III. Summary of Changes From the Draft Policy Letter to the Final
Policy Letter
IV. Response to Comments
V. Periodic Review of Viability Testing Methods
VI. Environmental Aspect and Impact Considerations
VII. Paperwork Reduction Act
VIII. Public Availability of the Final Policy Letter
I. Abbreviations
BWMS Ballast Water Management System
CFR Code of Federal Regulations
DHS Department of Homeland Security
ETV Environmental Technology Verification Program
FR Federal Register
IL Independent Laboratory
IMO International Maritime Organization
MPN Most Probable Number
NEPA National Environmental Policy Act
U.S.C. United States Code
USCG U.S. Coast Guard
VIDA Vessel Incidental Discharge Act of 2018
II. Background
The Vessel Incidental Discharge Act of 2018 (VIDA) found at Title
IX of the Frank LoBiondo Coast Guard Authorization Act of 2018, Public
Law 115-282, amended Section 312(p) of the Federal Water Pollution
Control Act (33 U.S.C. 1322). Pursuant to 33 U.S.C. 1322(p)(6)(D)(ii),
the Coast Guard published a draft policy letter in the Federal Register
on July 31, 2019 (84 FR 37330), receiving 38 submissions to the docket.
The final policy letter is issued pursuant to 33 U.S.C.
1322(p)(6)(D)(iv))which requires the
[[Page 16642]]
Coast Guard \1\ to describe type-approval testing methods, if any, for
ballast water management systems (BWMS) that render organisms nonviable
in ballast water and may be used in addition to the methods established
in title 46 Code of Federal Regulations (CFR) subpart 162.060. As more
fully discussed below, we do not describe any type-approval testing
methods for BWMS that render organisms nonviable in ballast water in
this policy letter. Rather, this policy letter establishes the
categories of information the Coast Guard deems necessary for the
evaluation of viability testing methods on the basis of best available
science and describes implementation of any accepted methods. The Coast
Guard will take into consideration any method that uses organism grow-
out and most probable number statistical analysis to determine the
concentration of organisms in ballast water that are capable of
reproduction. The Coast Guard will not take into consideration any
method that relies on a staining method to measure the concentration of
organisms greater than or equal to 10 micrometers and organisms less
than or equal to 50 micrometers. The term ``stain'' is undefined in
VIDA and is not consistently used in science to describe a specific
scientific procedure. A ``stain'' is defined by Merriam Webster's
dictionary \2\ in relevant part as a dye or mixture of dyes used in
microscopy to make visible minute and transparent structures, to
differentiate tissue elements or to produce specific chemical
reactions. According to this definition, a ``stain'' acts by suffusing
with color; coloring by processes affecting chemically or otherwise the
material itself. The Coast Guard will assess any evaluated type-
approval testing method to determine if it utilizes a stain.
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\1\ In DHS delegation 0170.1, the Commandant of the Coast Guard
is delegated the authority to carry out the functions in section 312
of the Federal Water Pollution Control Act (33 U.S.C. 1321, et seq.)
as amended by the Oil Pollution Act of 1990 (August 18, 1990; Pub.
L. 101-380; 104 Stat. 484).
\2\ Available at <a href="https://www.merriam-webster.com/dictionary/stain?src=search-dict-hed">https://www.merriam-webster.com/dictionary/stain?src=search-dict-hed</a> (last accessed 01/31/2022).
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In accordance with 33 U.S.C. 1322(p)(6)(D)(iv), and 46 CFR subpart
162.060, accepted viability testing methods outlined in this policy
letter or in future revisions are an alternative to testing procedures
in 46 CFR subpart 162.060, including the EPA/600/R-10/146,
Environmental Technology Verification (ETV) Program Generic Protocol
for the Verification of Ballast Water Treatment Technologies (ETV
Protocol).\3\
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\3\ Available at Generic Protocol for the Verification of
Ballast Water Treatment Technology [verbar] Science Inventory
[verbar] U.S. EPA (last accessed 03/31/2021).
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III. Summary of Changes From the Draft Policy Letter to the Final
Policy Letter
A. Summary of Changes
The final policy letter contains a number of changes from the draft
policy letter. This section lists all of the changes made to the draft
policy letter. Most of the changes discussed below are being made as a
direct response to submitted comments. A full discussion of the
comments and Coast Guard responses is available at Section IV below.
1. Administrative Process
As discussed in greater detail below, several comments focused on
the Coast Guard's administrative process in issuing the draft policy
letter. In Section 8 of the final policy letter, titled ``Process for
acceptance and use of new protocols,'' the Coast Guard added additional
details regarding the specific steps the Coast Guard will undertake in
fulfilling the administrative procedural requirements associated with
accepting a type-approval testing method.
2. Coast Guard Awareness of Available Testing Methods
As discussed in greater detail below, many comments were directed
at the Coast Guard's statement in the draft policy letter that, ``[a]t
the time of [publication of the draft policy letter], the Coast Guard
does not know of any type-approval testing protocols for BWMS that
render organisms nonviable in ballast water that are based on best
available science.'' In light of those comments, in the final policy
letter the Coast Guard clarifies that it is not that we are unaware of
viability testing methods; rather we are unaware of viability testing
methods that are based on best available science. As more fully
explained below, the acceptability of viability testing methods is
predicated on these methods being based on best available science,
which requires the ability to access and evaluate the supporting
scientific information.
3. Acceptance of Facility or Site-Specific Versus Generally Applied
Testing Methods
In the draft policy letter, the Coast Guard did not address the
potential to accept facility or site-specific viability testing
methods. This topic has been added to the final policy letter, along
with an explanation below of the circumstances in which information on
facility or site-specific viability testing methods would be assessed.
4. Scope and Applicability of ``Permanently''
In the draft policy letter, the Coast Guard described the
applicability of an accepted viability testing method within the
existing type-approval testing protocol. In this final policy letter,
the Coast Guard describes in detail a limitation on the applicability
of the term ``permanently'' to those viability testing methods
addressed by the final policy letter, not to any testing methods in the
existing requirements in 46 CFR subpart 162.060.
5. Opportunity To Submit Viability Testing Methods
The Coast Guard's draft policy letter explained the process for our
evaluation of any data and information that we may receive for
assessing a type-approval method. However, the draft policy letter
focused on establishing the type of information and material that the
public and stakeholders should provide to the Coast Guard in the form
of proposals for specific viability testing methods. We have revised
the final policy letter to clarify that the Coast Guard assumes the
burden for assessing information regarding available viability testing
methods. In this policy letter, the Coast Guard provides an explanation
of the best available science decision-making process. Further details
can be found below in the relevant responses to comments, as well as in
the final policy letter, and the Enclosure to the final policy letter.
6. Requirement to Consider Most Probable Number (MPN)
The legislative requirement in 33 U.S.C. 1322(p)(6)(D)(v) to
consider MPN was not explicitly addressed in the draft policy letter.
In the final policy letter, we make clear that the Coast Guard will
take MPN-based methods into consideration.
7. Requirement for Minimum Precision and Accuracy
The Coast Guard's initial position in the draft policy letter
stated that viability testing methods would need to include statistical
data demonstrating a stated minimum for precision and accuracy data. In
response to comments, Coast Guard deleted references to such standards
in the final policy letter and clarified the requirement to state that
information on method risk and uncertainty, including precision and
[[Page 16643]]
accuracy, is important to consider as part of the best available
science assessment, but that there are no criteria for specific values
to be met.
8. Requirement for Specific Number and Locations of Field Tests
The Coast Guard's initial position in the draft policy letter was
that viability testing methods would need to include validation data
from a specific number of tests from specific locations. In response to
comments, we have deleted references to minimum testing requirements in
the final policy letter and clarified the basis for requesting
information regarding the degree to which methods have been validated
over a range of geographic locations and conditions.
9. Definition of Best Available Science
The definition of best available science was not addressed in the
draft policy letter. In response to public comments, the Coast Guard
added new text to the final policy letter to define the term.
10. Best Available Science Evaluation in Assessing Viability Testing
Methods
In the draft policy letter, the Coast Guard did not address the
best available science evaluation of available information in assessing
viability testing methods. In the final policy letter, the Coast Guard
describes the general approach to evaluating information.
12. Equivalency to Existing Organism Enumeration Methods in ETV
Protocol as a Requirement for Viability Testing Method
In response to comments, the Coast Guard significantly modified
what was written in the draft policy letter regarding equivalency with
several testing method parameters in the ETV Protocol. In the draft
policy letter, the Coast Guard stated that the existing regulation
including the ETV Protocol ``set the standard for rigor, documentation
and transparency required of any BWMS type-approval testing protocol
submitted to the Coast Guard for acceptance. BWMS type-approval testing
for systems that render organisms nonviable will incorporate protocols
based on viability and will be subject to the same level of rigor
currently used for type-approval.'' The Coast Guard changed the final
policy letter to focus on evaluating best available science, not
adherence to a standard established by the ETV Protocol. The
requirement for equivalency was removed from the final policy letter
and the basis for the requested information is further explained in the
relevant sections below.
13. Existing Testing Method as Applied to Viability Testing
In the draft policy, the Coast Guard did not describe the use of
the existing testing method to test organism viability. However, in
response to comments expressing confusion on this issue, in the final
policy letter the Coast Guard elaborates on the VIDA provision
prohibiting the use of stains to test viability and how that relates to
accepting a viability testing method for use within the existing type-
approval program.
IV. Response to Comments
A. Overview of Responses
We appreciate the public's comments to the draft policy letter. The
draft policy letter remains available on the Coast Guard website at:
<a href="https://www.dco.uscg.mil/OES/Viability-Policy-Letter/">https://www.dco.uscg.mil/OES/Viability-Policy-Letter/</a>. Documents
related to the draft policy letter mentioned in this notice and all
public comments to the draft policy letter are available in our online
docket at <a href="https://www.regulations.gov">https://www.regulations.gov</a>, under Docket USCG-2019-0477, and
can be viewed by following that website's instructions. For more
information about privacy and submissions in response to this document,
see DHS's Correspondence System of Records notice (84 FR 48645,
September 26, 2018).
The Coast Guard received 39 submissions to the docket, one in
duplicate. In the following section, we respond to 38 separate
submissions. Each of the 38 submissions contains multiple comments on
the draft policy letter. In the discussion below, we distinguish
between submissions to the docket and the individual comments contained
in those submissions. The comments raised the following issues,
addressed below.
B. IMO Alignment
1. General Alignment
The Coast Guard received four comments relating to general
alignment between U.S. and International Maritime Organization (IMO)
test requirements. One comment asserted that nonconformity between U.S.
and IMO test requirements increases both ballast water management
system (BWMS) operational complexity and opportunities for
noncompliance. One commenter stated that the Coast Guard should accept
testing protocols that align with IMO accepted testing protocols
because doing so will avoid confusion that could result in wrongful
discharges; increase the efficiency of ships by removing a need to
operate with increased power; and decrease discharges of Greenhouse
gases due to less power being used on ships. Another comment requested
that the Coast Guard align testing protocols and type-approval
certificate limitations with international standards. One comment
stated that the Coast Guard is blocking the intent of VIDA, which the
commenter asserts is to adopt international BWMS MPN testing data, as a
basis for Coast Guard BWMS type-approval.
The Coast Guard notes that nothing in VIDA nor its legislative
history indicates Congressional intent to align domestic BWMS
regulations with the IMO Ballast Water Management Convention. When
adopting testing protocols, the Coast Guard is required to follow the
evaluation criteria and factors for consideration that are articulated
in VIDA. Under VIDA, the Coast Guard does not have the authority to
accept viability testing methods on any basis other than an evaluation
of best available science. Adopting a particular viability testing
method on the basis that it would provide greater alignment with IMO or
other international standards is not authorized under VIDA. Our
interpretation on this issue is more fully addressed in the section
immediately below.
2. Coast Guard Alignment With IMO Approach to MPN
The Coast Guard received eight comments relating to Coast Guard
alignment with the IMO's approach to the use of MPN statistical
analysis-based methods. Two comments questioned why the Coast Guard
does not follow IMO by recognizing both the vital stain method and the
MPN method for 10-50 um size range. Two comments suggested that the
Coast Guard has tacitly accepted the use of MPN by not objecting to or
abstaining from the IMO approval process. Three comments stated that
the Coast Guard should align domestic BWMS type-approval with IMO type-
approval under the Ballast Water Management Convention. One comment
noted the objectives of the IMO BWM Convention.
The U.S. is not a signatory to the 2004 IMO Ballast Water
Management Convention, and thus the U.S. Coast Guard is not bound by
acts taken pursuant to that convention. The Coast Guard cannot elect to
adopt a viability testing method simply because it is on the list of
methods recognized under the IMO Convention. According to 33 U.S.C.
1322(p)(6)(D)(ii), the Coast Guard must base its decision on the best
[[Page 16644]]
available science. Widely adopted methods, including those employed by
IMO Member States, can only be adopted by the Coast Guard if they can
be determined to be based on the best available science for measuring
viable organisms. However, the Coast Guard does not yet have the data
and information necessary for making that determination, and therefore
has not conducted the relevant evaluation. The Coast Guard will conduct
an evaluation of available information, including the information
identified and sought in the Enclosure, and make a determination, on
the basis of best available science, whether to accept one or more
specific methods. The Coast Guard's evaluation of information will be
guided by the definition of best available science contained in the
final policy letter.
C. Administrative Process
Six comments asserted that the Coast Guard did not follow proper
administrative processes by failing to conduct an impact study and by
violating the Administrative Procedure Act's (APA) requirement to
provide a reasoned basis for its policy letter.
Two commenters stated that the Coast Guard violated the APA by not
providing a reasoned basis for its best available science
determination. One comment noted that the Coast Guard has not done any
impact studies for the VIDA draft policy letter. Two comments stated
that the Coast Guard disregarded statutory requirements by not
accepting MPN to type-approve UV BWMS. One comment requested that the
Coast Guard take environmental impacts and opportunity for
noncompliance into account when accepting a testing protocol.
In developing the draft policy letter, the Coast Guard attempted to
provide concise guidance, responsive to the statutory directive in
VIDA. This guidance sought to anticipate questions and areas of
concern. However, some public comments provided the Coast Guard with
specific concerns requiring more attention and clarification. The Coast
Guard made changes in the final policy letter in consideration and as a
direct result of public commentary on the draft policy letter. Our
responses to comments provide the underlying reasoning for making
specific policy decisions. In specific response, please note the
discussion below in section D.1 providing the reasoned basis for the
Coast Guard's determination that, at the time of publication,
evaluation of best available science was impossible.
The Coast Guard did not engage in a rulemaking, due to a specific
mandate from Congress to issue a policy letter, not a rule. The APA
requirements for notice and comment do not apply to general statements
of policy pursuant to 5 U.S.C. 553(b)(A). Moreover, neither the draft
policy letter nor this final policy letter imposes legally binding
obligations or prohibitions on regulated parties. This is consistent
with statements of policy.
Taking into account that 33. U.S.C. 1322(p)(6)(D) requires the
publication of a policy letter, the Coast Guard determined that the
action falls under a categorical exclusion (CATEX) pursuant to
Department of Homeland Security Management Directive 023-01, Rev. 1,
associated implementing instructions, and U.S. Coast Guard
Environmental Planning Policy COMDTINST 5090.1, which guide the Coast
Guard in complying with NEPA (42 U.S.C. 4321 et seq.). CATEX A3 applies
to the promulgation of rules, issuances of rulings or interpretations,
and the development and publication of policies, orders, directives,
notices, procedures, manuals, advisory circulars, and other guidance
documents that are strictly administrative or procedural in nature or
that implement, without substantive change, statutory or regulatory
requirements. The action of publishing this policy letter is
categorically excluded under NEPA because it involves the publication
of a policy that is strictly administrative or procedural and because
it implements, without substantive change, statutory or regulatory
requirements.\4\ Furthermore, there are no extraordinary circumstances
present that prevent the application of the CATEX.
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\4\ Environmental Planning Implementing Procedures for CI 5090.1
Environmental Planning Policy, available at <a href="https://media.defense.gov/2020/Aug/18/2002479620/-1/-1/0/EP%20IP%20FINAL_COMBINED.PDF/EP%20IP%20FINAL_COMBINED.PDF">https://media.defense.gov/2020/Aug/18/2002479620/-1/-1/0/EP%20IP%20FINAL_COMBINED.PDF/EP%20IP%20FINAL_COMBINED.PDF</a> (last
accessed 10/07/2021).
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Two categories of actions that are not discussed in this letter
are: (1) Acceptance of viability testing method(s), and (2) type-
approval for proposed BWMS. The Coast Guard will issue subsequent
policy letters for the acceptance of viability testing methods pursuant
to 33 U.S.C. 1322(p)(6)(D)(iv)(III). The Coast Guard has provided
additional information about the basis for its best available science
decisionmaking in Section H. The Coast Guard further notes that these
administrative actions will require comprehensive environmental review
under NEPA, the preparation of a NEPA document such as an Environmental
Assessment or an Environmental Impact Statement, and compliance with
other environmental laws. For the purposes of NEPA, the USCG may choose
to use a programmatic approach, resulting in one initial NEPA document
that could assess potential environmental impacts of multiple testing
methods and type-approvals. A programmatic NEPA document could
alleviate the need for NEPA analyses on individual testing methods and
type-approvals, or at a minimum, would narrow the scope of such NEPA
reviews. Environmental reviews of actions following development of a
programmatic NEPA document would be undertaken to comply with NEPA (42
U.S.C. 4321 et seq.), Department of Homeland Security Management
Directive 023-01, Rev. 1, associated implementing instructions, and
U.S. Coast Guard Environmental Planning Policy COMDTINST 5090.1, and
all other applicable environmental mandates.
D. Assessment and Acceptance of Viability Testing Methods
1. Coast Guard Awareness of Available Testing Methods
From the 38 submissions to the docket, the Coast Guard received 45
comments concerning its statement that it was unaware of available
testing methods. Twenty-two comments interpreted the draft policy
letter to mean that the Coast Guard has previously evaluated viability
testing methods and determined that there were no acceptable viability
testing methods based on best available science. Eight comments noted
the availability of specific documentation regarding viability
assessment and stated that the Coast Guard is aware (or should be
aware) of the information. Eight other comments expressed skepticism
about the Coast Guard's evaluation of the available information
regarding methods for assessing the viability of organisms in ballast
water and associated determination that none are acceptable. One
comment stated that the Coast Guard must have assessed and excluded MPN
as a testing method and concluded that doing so effectively excludes
UV-based BWMS treatment. Three comments asserted that the Coast Guard
assessed and rejected MPN. One comment stated that the Coast Guard
needs to explain ``why [the Coast Guard] effectively dismissed an
otherwise unchallenged body of best available science.'' One comment
stated that the Coast Guard disregarded scientific support for MPN and
specific MPN protocols that may meet Coast Guard requirements. One
comment stated that a U.S. delegation was present at the IMO's Working
Group on Ballast Water Management, so the Coast Guard is aware of type-
approval testing methods
[[Page 16645]]
and protocols for BWMS that render organisms in ballast water
nonviable.
The forty-five comments described above all concluded, for various
reasons, that the Coast Guard had already evaluated information and
methods, including MPN, and determined that none were acceptable. The
draft policy letter apparently gave many readers the misimpression that
it is the Coast Guard's position that we have no awareness of viability
testing methods, generally. We wish to clear up that misimpression by
clarifying that it is not that we are unaware of viability testing
methods but that we are unaware of a viability testing method that is
based on best available science. At the time the draft policy letter
was made available for public comment, the Coast Guard did not have the
data and information needed for a best available science evaluation.
Accordingly, the draft policy letter set out the Coast Guard's approach
for collecting and evaluating information and the supporting science
during a ``best available science'' evaluation. Thus, in addition to
answering the VIDA mandates, one purpose of the draft policy letter was
to receive public comment on the proposed process for acceptance and
use of new testing methods--an approach that would entail assessing
information regarding viability testing methods within a best available
science evaluative framework. The Coast Guard could not undertake the
described best available science evaluation until we considered and
responded to public comment.
In completing the final policy letter, we considered all of the
public comments on the best available science evaluation that we
proposed in the draft policy letter as well as the specific information
that was described in the draft policy letter's Enclosure that would be
used in assessing available viability testing methods. A key purpose of
the final policy letter, therefore, is to finalize the Coast Guard's
best available science evaluative approach.
2. Acceptance of Facility or Site-Specific Versus Generally Applied
Testing Methods
The Coast Guard received three comments regarding the acceptance of
facility-specific methods versus generally applied testing methods. One
comment urged the Coast Guard to consider the pros and cons of standard
methods compared to facility-specific procedures. One comment stated
that the Coast Guard should adopt an approach to viability testing
methods that would allow each test facility to develop its own specific
MPN-based method(s). One comment asserted that specific media and
culture conditions used in grow-out during viability testing should be
left to the discretion of individual test facilities.
The Coast Guard will consider a viability testing method that is
intended for facility or site-specific use. In order to consider such
methods, the Coast Guard requires information on a viability testing
method's risks or uncertainties when used in a facility or site-
specific manner, within the global context of type-approval testing.
Such risks and uncertainties may possibly be mitigated through facility
or site-specific validations during use and adjustment of method
details based on facility or site-specific conditions.
E. VIDA Mandates
1. Scope and Applicability of ``Permanently''
The Coast Guard received six comments about the scope and
applicability of the term ``permanently.'' One comment touched on the
technical aspect of the FDA/CMFDA + motility method in the ETV Protocol
and its ability to characterize treated organisms as permanently dead.
One comment requested that the Coast Guard explain whether viability
assessment methods can be practicably applied to all organisms
regulated by BWM regulations. One comment stated that the Coast Guard
cannot conduct type-approval testing using the existing stain method
because it cannot meet the new statutory definition of ``permanently
incapable of reproduction.'' One comment requested that the Coast Guard
ensure that the accepted viability-based BWMS testing protocol
demonstrate permanent incapability to reproduce. One comment asserted
that the Coast Guard should exempt testing methods from VIDA's
requirement to demonstrate that organisms have been rendered
permanently incapable of reproduction because this VIDA requirement was
not applied to methods in the ETV protocol. One commenter explained
that a BWMS that merely renders organisms temporarily nonviable is
insufficient to ensure the protection of the Great Lakes and,
therefore, it is vitally important that a BWMS that is not based on a
live/dead standard, must be able to render organisms permanently
nonviable.
The Coast Guard notes that ``permanently'' applies to organism
reproduction under the 33 U.S.C. 1322(p)(6)(D)(i) definition of
``live'' and ``living.'' As such, the term has not been previously
considered in the context of the ballast water discharge standard
regulations contained in 46 CFR subpart 162.060. Additionally, the
statute defines the term ``render nonviable'' in 33 U.S.C.
1322(p)(1)(U) to mean ``the action of a ballast water management system
that renders the organism permanently incapable of reproduction
following treatment.'' The Coast Guard recognizes that the new
definitions in VIDA could be interpreted to impact the existing type-
approval program, but, this is not the case based on the plain meaning
of 33 U.S.C. 1322(p)(6)(D)(ii)(II) which states that an approved type-
approval testing method that renders organisms nonviable may be used in
addition to the methods established under 46 CFR subpart 162.060. The
Coast Guard will evaluate the scope of any methods considered for
acceptance to determine whether the method would be acceptable for
enumeration of all organisms in ballast water, or only a specific
subset. The Coast Guard will also assess the degree to which any
viability testing methods enumerate organisms that have been
permanently incapable of reproduction, i.e., are not capable of repair
and recovery of reproductive ability. Finally, the Coast Guard is not
authorized to ``exempt'' methods from the statutory requirement to
enumerate organisms that have been rendered permanently incapable of
reproduction.
2. Definition of ``Viable''
The Coast Guard received one comment suggesting a definition for
the term ``viable'' to mean an organism that is ``capable of growth and
replication and hence survival.'' The Coast Guard notes that VIDA does
not define the individual terms ``viable'' or ``nonviable.'' However,
VIDA does define the term ``render nonviable'' (in 33 U.S.C.
1322(p)(1)(U)) thus: ``The term `render nonviable', with respect to an
organism in ballast water, means the action of a ballast water
management system that renders the organism permanently incapable of
reproduction following treatment.'' Accordingly, the Coast Guard
determines that the definition of ``viable'' is capable of
reproduction.
3. Coast Guard Latitude in Considering Viability Testing Methods
The Coast Guard received four comments speaking to the agency's
latitude in considering viability testing methods. One comment stated a
preference for the VIDA standard to be based on live/dead status of
organisms, not viability. One comment requested that the Coast Guard
evaluate risks posed by the introduction of living but nonviable
organisms. One comment
[[Page 16646]]
asserted that requiring BWMS to kill organisms rather than render them
nonviable provides no additional disinfection benefit. One comment
requested that the Coast Guard recognize a viability assessment in
approving BWMS.
These comments seem to assert that either the Coast Guard should
consider a viability standard or not consider it; or at least not
consider it until the Coast Guard first evaluates the risks posed by
introduction of living but nonviable organisms. The Coast Guard has no
discretion in this area. The legislation in 33 U.S.C. 1322(p)(6)(D)
requires that we consider viability testing protocols.
4. Opportunity To Submit Viability Testing Methods
The Coast Guard received two Comments regarding the request for the
public and stakeholders to submit viability testing methods. One
comment stated that, contrary to Congressional intent, the Coast Guard
shifted the burden of validating BWMS testing protocols onto
manufacturers instead of the agency. One comment interpreted the draft
policy letter's proposed procedure to mean that BWMS manufacturers
would submit methods as part of type-approval testing.
These comments suggest that the Coast Guard is not fulfilling its
Congressional mandate to assess viability testing methods. This is not
the case. The statute requires a viability testing method to be based
on best available science. In order to meet this requirement, we have
determined that the most efficient and cost effective method of
collecting relevant information on best available science is to first
describe that information in detail in the Enclosure to the policy
letter. The final policy letter sets forth the mechanism for
stakeholders to submit viability testing methods and associated
supporting information such as documentation of validation studies, the
scientific basis for the method, and assumptions or requirements, as
described in the Enclosure to the policy letter. The Coast Guard cannot
accept a viability testing method without assessing several critical
aspects of information, namely method scope, details, and validation.
In evaluating best available science, the Coast Guard may assess
publically available information in addition to that submitted, to
ensure all aspects of the best available science definition above are
fully and accurately described. At the time that a viability testing
method is accepted, the Coast Guard will revise the final policy letter
in accordance with 33 U.S.C. 1322(p)(6)(D)(iv)(III).
5. Applicability of the Qualifier ``If Any''
The Coast Guard received one comment asserting that the term ``if
any'' in 33 U.S.C. 1322 (p)(6)(D)(ii) refers to BWMS, not type-approval
testing methods and protocols.
The Coast Guard notes that the statute's location of the qualifier
``if any'' differs between the draft policy letter and the final policy
letter. However, based on the plain reading of the statute pertaining
to the final policy letter (33 U.S.C. 1322(p)(6)(D)(iv)(I), we believe
the ``if any'' language applies to type-approval testing methods.
Therefore, the Coast Guard determines that the statute's different
location of the qualifying ``if any'' language does not affect the need
to evaluate the science supporting a viability testing method within a
best available science evaluative framework.
6. Requirements To Issue Policy ``in Coordination With'' the EPA
The Coast Guard received one comment questioning whether the Coast
Guard had coordinated with EPA in concluding that no methods were
available. We appreciate the question and would again like to emphasize
that we did not mean to suggest or imply in the draft policy letter
that there are no available viability testing methods, but rather that
we have not evaluated the science supporting any viability testing
methods within a best available science evaluative framework. We
discuss this point in Section D.1.under the paragraph header ``Coast
Guard awareness of available testing methods.'' Second, the Coast Guard
received EPA's input on the draft policy letter and integrated that
input into the draft policy letter prior to its publication in the
Federal Register.
7. Determination of No Acceptable Viability Testing Methods
The Coast Guard received eight comments on the determination of no
acceptable viability testing methods. One comment disagreed with the
Coast Guard's determination not to accept any testing method that uses
grow-out for organisms greater than or equal to 10 micrometers and less
than or equal to 50 micrometers because the existing type-approval
testing method for bacteria relies on organism grow-out. Six comments
requested that the final policy letter identify one or more accepted
methods, and further assert that the Coast Guard does not have
discretion to determine that none are acceptable. One comment asserted
that Congress's clear intent was for the final policy letter to be a
final action incorporating the best MPN or similar method(s), not the
starting point for a new method evaluation using a pre-existing
regulatory process.
The Coast Guard disagrees with the equivalency between the existing
testing method for bacteria and acceptance of a testing method that
uses grow-out for organisms greater than or equal to 10 micrometers and
less than or equal to 50 micrometers. The Coast Guard notes that
utilizing selective media to enumerate specific organisms is
fundamentally different from enumerating mixed assemblages of
organisms. Further, at the time of the ETV Protocol development, those
specific methods for bacteria existed as fully validated standard
methods.
In response to comments asserting that the Coast Guard was required
to describe in the draft policy letter, one or more viability testing
methods, Congress provided the Coast Guard with the discretion to
determine ``if any'' type-approval testing methods are acceptable. The
Coast Guard disagrees with the assertion that we were required to
accept a testing method from those currently available. The statute
does not require us to accept currently available viability testing
methods but to accept viability testing methods that are based on best
available science. As explained above, the Coast Guard's acceptance of
viability testing methods must result from assessing information
regarding viability testing methods within a best available science
evaluative framework.
The Coast Guard disagrees that the final policy letter is required
to be a final action with no ongoing assessment of viability testing
methods. Nor do we agree that we have made the policy letter ``the
starting point for a new method evaluation using a pre-existing
regulatory process.'' Under 33 U.S.C. 1322(p)(6)(D)(iv)(III), Congress
expressly contemplates an ongoing assessment of viability testing
methods by directing the Coast Guard to incorporate accepted viability
testing methods into future revisions of the final policy letter. We
have determined that a revision of the policy letter will require
several steps prior to completing the action of accepting a viability
testing method. We must collect relevant information about viability
testing methods, assess that information, and comply with any
implicated legal authorities such as NEPA. Consequently, any
prospective acceptance of a viability testing method will require
comprehensive environmental review under NEPA, the preparation of a
NEPA document such as an Environmental Assessment or an Environmental
Impact Statement, and
[[Page 16647]]
compliance with other environmental laws. VIDA did not waive, and we
cannot choose to ignore, these requirements. The Coast Guard must
adhere to these procedural requirements and, together with the
assessment of the information necessary to accept a type-approval
testing method, it was not possible to accept a type-approval testing
method within the 180 day timeframe that the statute provided with
respect to the final policy letter.
The Coast Guard published a draft policy letter that sought public
comment on the process for acceptance and use of new protocols. This
process, incorporated in the final policy letter, will help the Coast
Guard assess viability testing methods based on best available science.
At the time that the Coast Guard accepts a viability testing method
using the criteria established in the policy letter, we will revise the
policy letter to reflect the Coast Guard's acceptance in accordance
with 33 U.S.C. 1322(p)(6)(D)(iv)(III).
8. Applicability of ``Best Available Science'' Requirement
The Coast Guard received three comments asserting that the Coast
Guard did not base its draft policy letter on best available science.
Of these three comments that generally assert that the draft policy
letter was not based on the best available science, one commenter
specifically asserted that the Coast Guard misinterpreted the statutory
directive because the Coast Guard ``issue[d] a draft policy letter that
is not based on best available science [nor did it] discuss what best
available science is or what it shows.'' The commenter goes on to say
that, ``instead USCG appears to have interpreted the statutory
directive to ask USCG to determine whether there are any type-approval
methods that are themselves based on best available science.''
With respect to the draft policy letter, 33 U.S.C.
1322(p)(6)(D)(ii), requires the Coast Guard to, ``publish a draft
policy letter, based on the best available science, describing type-
approval testing methods and protocols for BWMS, if any . . .''
(Emphasis added). With respect to the final policy, 33 U.S.C.
1322(p)(6)(D)(iv) requires the Coast Guard to, ``publish a final policy
letter describing type-approval testing methods, if any, for ballast
water management systems that render nonviable organisms in ballast
water . . . [that] shall be evaluated by measuring the concentration of
organisms in ballast water that are capable of reproduction based on
the best available science that may be used in addition to the methods
established under subpart 162.060 of title 46, Code of Federal
Regulations (or successor regulations).'' (Emphasis added). Though the
wording in 33 U.S.C. 1322(p)(6)(D)(ii) and (iv) differs slightly, we
interpret their meaning to be the same--the Coast Guard's acceptance of
viability testing methods must result from assessing information
regarding viability testing methods within a best available science
evaluative framework. Consequently, one purpose of the draft policy
letter was to receive public comment on the proposed process for
acceptance and use of new testing methods--an approach that would
entail assessing information regarding viability testing methods within
a best available science evaluative framework.
9. Requirements To Consider MPN
The Coast Guard received eight comments regarding the requirement
to consider MPN. Four comments asserted that VIDA requires the Coast
Guard to adopt the MPN method. Two comments asserted that VIDA requires
the Coast Guard to consider MPN in the draft policy letter. One comment
stated that Coast Guard must accept a culture-based viability testing
protocol because that is the only way to determine if an organism is
permanently incapable of reproduction. One comment stated that the
``MPN method'' is intended to be added to the Coast Guard BWMS type-
approval testing requirements.
VIDA requires that, in developing the final policy letter, the
Coast Guard ``take into consideration a testing method that uses
organism grow-out and most probable number statistical analysis.'' The
Coast Guard's final policy letter reflects the requirement to consider
such testing methods. We note that the requirement to consider organism
grow-out and most probable number statistical analysis were not
included in the VIDA mandate for the draft policy letter; consequently,
we did not address it.
The Coast Guard does not consider the term ``MPN'' to refer to any
specific method intended to determine the concentration of viable
organisms in ballast water. MPN is a general procedure that uses serial
dilutions and statistical calculations to estimate concentrations of
organisms in original samples and the organism grow-out is used to
identify viable organisms. There can be many different specific methods
that incorporate MPN or grow-out to identify numbers of viable
organisms. Different methods may target specific organisms or broad
assemblages of organisms depending on the selection of growth media and
conditions. The Coast Guard is required to assess the permanency of an
organism's inability to reproduce and will do so under a best available
science evaluative framework.
F. Equivalency to ETV Protocol as a Requirement for Viability Testing
Method
1. Requirement for Minimum Precision and Accuracy
The Coast Guard received two comments directed at the requirement
in the draft policy letter enclosure for the precision and accuracy of
viability testing methods to be at least equivalent to the precision
and accuracy of methods accepted in existing regulations. The first
comment points out that because VIDA does not require an equivalent
level of precision and accuracy, the Coast Guard should remove this
requirement. We agree that the ETV Protocol's precision and accuracy
are not benchmarks for a viability testing method. However, we must
assess the precision and accuracy for two reasons. First, we must
evaluate the scientific information supporting a testing method in a
manner that maximizes the quality, objectivity, and integrity of
information, including statistical information. Second, we must
evaluate the scientific information that supports a testing method in a
manner that clearly documents and communicates risks and uncertainties
in the scientific basis. Therefore, we are considering those categories
of information.
The other comment noted that lesser precision and accuracy of best
available methods for evaluating nonviable organisms, compared to
existing methods for dead organisms, should not disqualify a proposed
method.
We acknowledge that the existing testing method under 46 CFR
subpart 162.060 was never evaluated on the basis of best available
science. However, VIDA included a best available science criteria
relating to viability testing methods. As stated above, we have
determined that a best available science evaluation requires the Coast
Guard to collect information, including that regarding precision,
accuracy and associated statistical calculations for any potential
viability testing method.
2. Requirement for Specific Number and Locations of Field Tests
The Coast Guard received one comment disagreeing with requirements
in the draft policy letter's enclosure regarding the validation of
viability testing methods be conducted at a specific number of
locations in the U.S.
[[Page 16648]]
because organisms in the U.S. are not aquatic nuisance species.
The Coast Guard agrees that there should not be a requirement for a
specific number or geographic range of validation locations.
Accordingly, in the final policy letter, the Coast Guard changed the
requirement such that the focus is on demonstrating the viability
testing method's capability to effectively quantify organisms over the
geographic range of its intended use, not on meeting a specific number
of test locations.
3. Requirement for General Consistency With the Existing Testing Method
The Coast Guard received eight comments relating to the requirement
for consistency with the ETV Protocol when it comes to viability
testing methods. Three comments disagreed with requirements specified
in the draft policy letter's enclosure as being inconsistent with or
exceeding the ETV Protocol's requirements. Another comment stated that
the ETV Protocol cannot be used as the standard for scientific rigor in
assessing viability testing methods. One comment requested the Coast
Guard describe the level of scientific rigor applied in accepting the
existing testing method. One comment asserted that the Coast Guard's
acceptance of the existing testing method created the comparative level
of scientific rigor that must be considered when assessing viability
testing methods. One comment stated that a significant flaw in the
existing type-approval testing method is that it does not incorporate
an incubation period and therefore does not test the ability of
organisms to repair after a measurement of dead status. One comment
stated that the use of a vital stain is not an accurate assessment of
living organisms.
The Coast Guard agrees with the commenters' statements that the ETV
Protocol should not establish the standard for acceptance of type-
approval testing protocols. The Coast Guard acknowledges that the ETV
Protocol is not ``perfect science'' and that the acceptance of testing
methods under that protocol does not set a requirement for acceptance
under VIDA. In establishing a best available science evaluative
framework, we have determined that the categories and types of
information described in the Enclosure to the policy letter are
appropriate and necessary in assessing viability testing methods.
G. Identification of BWMS That Are Type-Approved on the Basis of
Viability
The Coast Guard received three comments on the requirement that
BWMS type-approval certificates be annotated to differentiate between
BWMSs approved on the basis of viability and those that are approved
based on rendering organisms dead.
In response to these comments, the Coast Guard refers to 33 U.S.C.
1322(p)(6)(D)(ii)(II)(bb) which includes the explanation that a testing
method is used ``to certify the performance of each ballast water
management system [that renders organisms nonviable in ballast
water].'' To carry out this requirement, the Coast Guard determined
that BWMS tested to a viability standard must be certified as such.
Consequently, the final policy letter retains the requirement to
annotate a BWMS type-approval certificate to reflect the basis for
approval. The Coast Guard notes that in addition to Congressional
direction regarding certification of viability-based BWMS, annotation
is necessary to help avoid confusion regarding the intended effect of a
specific BWMS model. Under 46 CFR 162.060-10(g), the approval
certificate will list conditions of approval applicable to the BWMS. We
believe that an annotation to the type-approval certificate is the
easiest method of avoiding confusion.
H. Best Available Science
1. Definition of Best Available Science
The Coast Guard received twenty-one comments about the definition
of best available science. Ten of these comments assert that the Coast
Guard should adopt an MPN method as representing the best available
science because it is accepted for use under the IMO Ballast Water
Management Convention. Three comments assert that the Coast Guard's
interpretation of best available science improperly requires ``perfect
science.'' Five comments requested that the Coast Guard provide its
reason for not following guidance from the legal and scientific
community on interpreting the term ``best available science.'' Three
comments asserted that submissions to the docket in response to the
draft policy letter provide a best available science basis for
accepting the MPN method. In response to these comments, we point out
that VIDA does not define ``best available science.'' Therefore, the
Coast Guard must use its discretion in determining what constitutes
``best available science.'' The Coast Guard notes a cogent definition
for the term is found in the immediately preceding section of the
Federal Water Pollution Control Act (FWPCA), 33 U.S.C. 1321(a)(27)
which states: ``the term `best available science' means science that--
maximizes the quality, objectivity, and integrity of information,
including statistical information; uses peer-reviewed and publicly
available data; and clearly documents and communicates risks and
uncertainties in the scientific basis for such projects.'' Although not
intended to apply to other sections of the FWPCA, the Coast Guard notes
that the definition in section 1321 aligns with our general
understanding of other working definitions for the term ``best
available science'' when used in federal legislation. The definition in
section 1321 is concise and informative, providing three elements that
can be generically applied to the evaluation of scientific information.
This definition is a congressionally defined term within the same Act
as the legislative requirements we are required to implement in 33
U.S.C. 1322. The Coast Guard notes that while applying this definition
to the evaluation of type-approval testing methods is different from
the way that the definition is applied in Section 1321, the definition
speaks to the general concept of assessing scientific information,
independent of the topic of that science.
2. Best Available Science Evaluation in Assessing Viability Testing
Methods
The Coast Guard received eight comments about the best available
science evaluation for assessing viability testing methods. One comment
stated that the draft policy letter does not establish any specific
process by which a viability-based methodology could be approved. One
comment stated that it is critical that a best available science
determination be based on an up-to-date understanding of the relevant
science. Three comments asserted that the Coast Guard must describe a
detailed process for evaluating viability testing methods, taking into
consideration the best available science--including one comment seeking
details on the determination of whether organisms are ``permanently
non-viable.'' Two comments asserted that the Coast Guard should
research best available science before developing a process. One
comment requested that the Coast Guard work with various stakeholders
in developing and accepting viability-based BWMS type-approval
protocols.
The Coast Guard will assess the most current data and information
available that supports viability testing methods on the basis of best
available science pursuant to the approach outlined in the final policy
letter. The Coast Guard has not yet conducted an assessment of
supporting information and data for
[[Page 16649]]
viability testing methods for the reasons discussed in Section D. 1.
Once we complete this assessment and make a determination on
acceptability, we will describe the basis for our acceptance,
recognizing that the best available science evaluation itself does not
result in a conclusory determination of acceptability.
I. Existing Type-Approval Testing Requirements
1. Existing Type-Approval Program Maintained in Effect
The Coast Guard received five comments about the existing type-
approval program remaining in effect. One comment agreed with the Coast
Guard's conclusion that accepted viability methods would be used as
part of the ETV protocol process. One comment noted that the existing
type-approval testing method will remain in place until Coast Guard
accepts a viability-based type-approval testing method. One comment
supported a type-approval testing protocol that combined live/dead and
viability assays. One comment agreed with the Coast Guard decision to
add viability testing methods to the existing type-approval testing
methods. One comment asserted that the final viability policy letter
should not address how viability testing methods would be incorporated
into the type-approval testing procedures specified in regulation.
Any accepted method will be used in addition to existing type-
approval testing methods per 33 U.S.C. 1322 (p)(6)(D)(iv)(II). At the
time that one or more viability testing methods are accepted, viability
testing methods will only be added to the discrete sections of the
type-approval test requirements for which the specific viability
testing method applies. Sections 5.4.6.4 and .5 of the ETV Protocol
address enumeration of organisms in ballast water. Accepted viability
testing methods for organisms greater than 50 um in size would be
accepted for use under Section 5.4.6.4, and viability testing methods
for organisms in the 10-50 um size group would be accepted for use
under 5.4.6.5. An accepted viability testing method may describe
alternative procedures relating to aspects of the ETV Protocol beyond
those described above. The specifications for such alternatives will
then be described in a revision to the final policy letter and must
directly relate to measuring the concentration of organisms in ballast
water that are capable of reproduction. Under VIDA, the Coast Guard
will not assess any method that enumerates living organisms (i.e., not
dead). If no viability testing methods are accepted for a specific size
class or type of organism for which testing is required, then existing
test methods identified in the ETV Protocol remain in effect and must
be used.
2. Existing Testing Method as Applied to Viability Testing
The Coast Guard received five comments about the existing testing
method as applied to viability testing. One comment states that the ETV
Protocol utilizes vital stain to determine organism viability. Three
comments noted that vital stain does not assess viability. Another
comment claimed that testing organisms with MPN gives a better
viability result than vital stains.
The existing testing method specified in the ETV Protocol does not
assess organism viability, meaning the ability to reproduce, and will
not be used for that purpose. Additionally, 33 U.S.C.
1322(p)(6)(D)(v)(II) prohibits the Coast Guard from considering a
testing method that relies on a staining method to measure the
concentration of organisms greater than or equal to 10 micrometers and
less than or equal to 50 micrometers. The term ``stain'' is undefined
in VIDA and is not consistently used in science to describe a specific
scientific procedure. A ``stain'' is defined by Merriam Webster's
dictionary \5\ in relevant part as a dye or mixture of dyes used in
microscopy to make visible minute and transparent structures, to
differentiate tissue elements or to produce specific chemical
reactions. According to this definition, a ``stain'' acts by suffusing
with color; coloring by processes affecting chemically or otherwise the
material itself. The Coast Guard will assess any submitted type-
approval testing method information to determine if it utilizes a
stain.
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\5\ Available at <a href="https://www.merriam-webster.com/dictionary/stain?src=search-dict-hed">https://www.merriam-webster.com/dictionary/stain?src=search-dict-hed</a> (last accessed 01/31/2022).
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J. Topics Outside the Scope of the Draft Policy Letter
1. Information Provided in Support of a General or Specific Method
Seventy-five comments offered support for viability testing
methods. Fifty comments expressed support, either generally or for one
or more specific viability testing methods. Eighteen comments cited to
specific supporting information for one or more specific viability
testing methods. Seven comments noted scientific information supporting
MPN usage in water treatment.
The Coast Guard did not solicit information regarding potential
viability testing methods in the Federal Register notice requesting
comments on the draft policy letter. Therefore, comments proposing or
supporting the acceptance of specific methods are outside the scope of
the draft policy letter. Going forward, submissions in response to the
final policy letter or its enclosure may include, by reference,
information previously submitted to the docket in response to the draft
policy letter, to avoid duplication of effort, if desired. However, the
Coast Guard cautions that, when submitting information responsive to
the final policy letter or its enclosure, care should be taken to
ensure that any submitted viability testing method and associated
scientific information and data responds to the specific categories of
information identified in the final policy letter or its enclosure.
2. General Support for VIDA
The Coast Guard received five comments offering general support for
VIDA. One comment agreed with VIDA's definition of ``live'' and
``living.'' Two comments generally supported the use of viability-based
BWMS type-approval testing. One comment stated support for the
discharge of nonviable organisms in ballast water as effective in
preventing the spread of invasive species. One comment supported the
use of best available science in assessing ballast water treatment
options. One comment noted the importance of determining permanent
nonviability.
While the Coast Guard appreciates these commenters' concern
regarding ballast water treatment, we consider these six comments to be
outside the scope of the draft policy letter. As discussed above, the
draft policy letter sought public comment on the process for accepting
type-approval testing methods and protocols for BWMS, if any, that
render organisms nonviable in ballast water and may be used in addition
to the existing testing methods.
3. 2012 BWDS Rule Requirements
The Coast Guard received ten comments relating to the 2012 BWDS
rule. One comment noted that in the 2012 BWDS rulemaking, the Coast
Guard noted differences in the Coast Guard's 2012 BWDS and the IMO BWM
convention. One comment claimed that existing regulations are designed
to ensure ballast water sterilization. One comment claimed that Coast
Guard regulations do not address the technical aspects of quantifying
organisms in ballast water and that Coast Guard
[[Page 16650]]
regulations do not touch on the methods available to treat BW to reach
the thresholds (discharge standards). Six comments recommended changes
to the 2012 BWDS rule, including amending BWM requirements, the BWDS,
the type-approval testing protocol incorporated by reference, and
adoption of emerging technologies. One comment stated that in the
preamble discussion of the 2012 BWDS rule, the Coast Guard proposed to
align with IMO regarding the use of viability testing methods for BWMS
approvals.
While the Coast Guard appreciates these commenters' concern
regarding ballast water treatment, we consider these ten comments
outside the scope of the draft policy letter. As discussed above, the
draft policy letter sought public comment on the process for accepting
type-approval testing methods and protocols for BWMS, if any, that
render organisms in ballast water nonviable and that may be used
addition to the existing testing methods.
4. BWMS Protocols for the Great Lakes
The Coast Guard received one comment requesting that the Coast
Guard require the use of BWMS on all ships traversing the Great Lakes,
whether land based or onboard.
This comment is out of scope as it relates to use of BWMS for
vessels on the Great Lakes, instead of the testing method that could be
used to test BWMS. The Coast Guard acknowledges the comment and notes
that VIDA addresses applicability of ballast water regulation in the
Great Lakes under other provisions.
5. Agency Decisions Made Prior to VIDA Enactment
The Coast Guard received five comments discussing Coast Guard
decisions made prior to the enactment of VIDA. One comment asserted
that the Coast Guard made multiple scientific errors in 2016 when the
Coast Guard denied an appeal to an earlier Coast Guard decision that
rejected the use of MPN. One comment stated that the Coast Guard
switched rationales for not accepting MPN, asserting that the USCG
rejected MPN in 2015 because it did not meet the BWDS established in
the 2012 rule. Now, the commenter asserts we are rejecting MPN on the
basis that MPN is not based on the best available science. One comment
questioned why the Coast Guard allows culture-based methods for
bacteria but not for 10-50 um organisms. Two comments objected to the
Coast Guard's rejection of the MPN method for enumeration of viable
microorganisms that was published in the 2015 Maritime Commons.
Prior to the enactment of VIDA, the Coast Guard made decisions
under other legal authorities. Under VIDA, the Coast Guard is required
to evaluate the acceptability of viability testing methods, on the
basis of best available science, giving consideration to any MPN-based
methods. Consequently, comments pertaining to assessment of VIDA
requirements through the lens of other authorities are not relevant to
the evaluation of type-approval testing method on the basis of best
available science required under VIDA.
6. Factors for Consideration in Assessing BWMS Technology Type
The Coast Guard received fourteen comments relating to factors that
Coast Guard would consider in assessing viability testing methods based
on the impacts of BWMS technology type. One comment provided an opinion
on the associated environmental benefits or drawbacks of particular BWM
technologies. One comment requested that the Coast Guard evaluate
environmental risks of technologies designed to render organisms living
but nonviable. One comment mentioned that a filter and UV based BWMS
requires more than three times the power consumption if designed
according to results from CMFDA testing. The comment further noted that
such design will not be optimal, and sometimes impossible to retrofit
on-board ships in our main target market segments. The comment
requested the Coast Guard consider energy usage in assessing acceptable
viability-based type-approval testing methods. One comment provided an
opinion on water quality impacts of UVC radiation versus other BWM
treatment technologies. One comment stated that the Coast Guard's BWMS
testing requirements result in UV based system having to be
significantly overpowered, causing the systems to have larger
footprints and consume more energy than necessary to be effective. Two
comments claimed that the Coast Guard, in not accepting viability
assays, is not allowing the use of UV technology. One comment stated
that the Coast Guard is biased against UV-based BWMS technologies and
that the Coast Guard's rejection of low-energy UV BWMS that render
certain microorganisms is contrary to the National Invasive Species Act
(NISA) and international norms. One comment asserted that the Coast
Guard should recognize low-dose UV as a preferred BWMS technology
because it is an effective and economical treatment option for the
maritime industry. One comment supported type-approval testing methods
that are tailored to specific treatment technologies. One commenter
recommends grow-out methods for measuring the response of all
treatments because both inactivated and killed cells will not grow out.
One comment supported the use of appropriate viability testing methods
for type-approving UV BWMS. One comment noted there are limitations of
UV-based treatment that, in some situations, will make UV-based
processes not the process of choice. One comment asserts that the Coast
Guard is concerned that UV-based methods may not render organisms
permanently nonviable.
Our response to these comments is that we interpret VIDA to be
``technology neutral'' when it comes to the acceptance of type-approval
protocols. The Coast Guard determines that Congress did not express an
intent to either disadvantage or create preference for any specific
BWMS technologies. In other words, VIDA does not address BWMS treatment
technology types beyond the general qualification that they render
organisms nonviable, and the acceptance of viability testing methods is
based on best available science.
V. Review of Viability Testing Methods
The Coast Guard will revise the final policy letter once any
viability testing methods are accepted. The Coast Guard invites
voluntary submission of viability testing methods and associated
scientific information and data responsive to the specific categories
of information identified in the final policy letter or its enclosure.
Upon receipt of a submission, the Coast Guard will evaluate the
submitted viability testing method, and associated scientific
information and data, on the basis of best available science.
Afterwards, the Coast Guard will conduct NEPA-compliant environmental
analysis on any potentially acceptable viability testing methods, to
include any required public involvement. If, pursuant to these
analyses, the Coast Guard determines that a viability testing method is
acceptable, we will publish a revision of the final viability policy
letter to include any accepted viability testing methods.
Revisions to the final policy letter, if any, may also occur during
the 5 year review of standards of performance, pursuant to 33 U.S.C.
1322(p)(D)(iv)(III). Reviewing testing methods, immediately following
any changes to standards of performance and associated type-approval
requirements, will allow the Coast Guard to expedite the inclusion of
changes to the type-approval regulations, including methods
[[Page 16651]]
for testing viability, responsive to any new standards of performance.
We are mindful of the potential pitfalls associated with reviewing
proposed methods submitted at any time. We note that significant
resources are required to conduct the best available science evaluation
of viability testing methods. Once the Coast Guard initiates review of
a viability testing method, subsequent submissions will be reviewed in
the order received.
In addition to participating in the revision process described
above, states may petition for changes to the policy establishing the
review and acceptance process, pursuant to 33 U.S.C. 1322(p)(7). Such
changes would pertain to the substance of the policy letter, which
establishes the process for accepting and implementing viability
testing methods, and would not be for the purpose of revising the
policy letter to accept a specific viability testing method. This is
due to the phrasing of 33 U.S.C. 1322(p)(7), which allows for petitions
to review a policy if there exists new information that could
reasonably result in a change to the standard of performance,
regulation, or policy or to a determination on which the policy was
based.
VI. Environmental Aspect and Impact Considerations
a. The development of the final policy letter and the general
policies contained within it have been thoroughly reviewed by the Coast
Guard. Pursuant to NEPA (42 U.S.C. 4321 et seq.), Department of
Homeland Security Management Directive 023-01, Rev. 1, associated
implementing instructions, and U.S. Coast Guard Environmental Planning
Policy COMDTINST 5090.1, we have determined that publishing the final
policy letter, which does not accept a testing method, is categorically
excluded under CATEX A3 listed in Appendix A, Table 1 of the Department
of Homeland Security Instruction 023-01-001-01, Rev. 1.\6\ We have also
determined that no extraordinary circumstances exist which prevent the
application of the CATEX.
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\6\ <a href="https://www.dhs.gov/sites/default/files/publications/DHS_Instruction%20Manual%20023-01-001-01%20Rev%2001_508%20Admin%20Rev.pdf">https://www.dhs.gov/sites/default/files/publications/DHS_Instruction%20Manual%20023-01-001-01%20Rev%2001_508%20Admin%20Rev.pdf</a>.
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CATEX A3 pertains to the promulgation of rules, issuance of rulings
or interpretations, and the development and publication of policies,
orders, directives, notices, procedures, manuals, advisory circulars,
and other guidance documents, such as ``those of a strictly
administrative or procedural nature,'' or ``those [implementing],
without substantive change, statutory or regulatory requirements.''
b. The final policy letter will not have any of the following:
Significant cumulative impacts on the human environment; substantial
controversy or substantial change to existing environmental conditions;
or inconsistencies with any Federal, State, or local laws or
administrative determinations relating to the environment. All future
specific actions resulting from the general policy in the final policy
letter must be individually evaluated for compliance with NEPA (42
U.S.C. 4321 et seq.), Department of Homeland Security Management
Directive 023-01, Rev. 1 and associated implementing instructions, U.S.
Coast Guard Environmental Planning Policy COMDTINST 5090.1, Executive
Order 12114 Environmental Effects Abroad of Major Federal Actions, and
compliance with all other applicable environmental mandates.
VII. Paperwork Reduction Act
The Coast Guard determines the final policy does not require a new
collection of information under the Paperwork Reduction Act of 1995, 44
U.S.C. 3501.
VIII. Public Availability of the Final Policy Letter
The Coast Guard developed the final policy letter in coordination
with the EPA pursuant to 33 U.S.C. 1322(p)(6)(D)(iv). The final policy
letter is available in the docket and on the following USCG website:
<a href="https://www.dco.uscg.mil/OES/Viability-Policy-Letter/">https://www.dco.uscg.mil/OES/Viability-Policy-Letter/</a>. All comments
received are also posted without change to <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
For instructions on locating the docket, see the ADDRESSES portion of
this Federal Register document.
Dated: March 15, 2022.
Jeffrey G. Lantz,
Director of Commercial Regulations and Standards, Office of the
Commandant, U.S. Coast Guard.
[FR Doc. 2022-06201 Filed 3-23-22; 8:45 am]
BILLING CODE 9110-04-P
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</html>Indexed from Federal Register on March 24, 2022.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.