Final Policy Letter Describing Type-Approval Testing Methods for Ballast Water Management Systems (BWMS) That Render Organisms Nonviable in Ballast Water, 16641-16651 [2022-06201]

Agencies

• Coast Guard
• DEPARTMENT OF HOMELAND SECURITY

[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 [www.gpo.gov]
[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 
https://www.regulations.gov, 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 https://www.merriam-webster.com/dictionary/stain?src=search-dict-hed (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: 
https://www.dco.uscg.mil/OES/Viability-Policy-Letter/. 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 https://www.regulations.gov, 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 https://media.defense.gov/2020/Aug/18/2002479620/-1/-1/0/EP%20IP%20FINAL_COMBINED.PDF/EP%20IP%20FINAL_COMBINED.PDF (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 https://www.merriam-webster.com/dictionary/stain?src=search-dict-hed (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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    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: 
https://www.dco.uscg.mil/OES/Viability-Policy-Letter/. All comments 
received are also posted without change to https://www.regulations.gov. 
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