Federal Register / Vol. 87, No. 57 / Thursday, March 24, 2022 / Rules and Regulations 16641 

(86 FR 8727) and responded to the 

comments received in response to the 

NPRM in the September 23rd final rule, 

so the provision of another comment 

period was an error in EPA’s final 

action. This document corrects the 

erroneous language. This document has 

no impact on West Virginia’s 

incorporation by reference of the 

NAAQS or the Clean Air Act (CAA) 

requirements applicable to West 

Virginia, only the effective date. 

Need for Correction 

As published, the September 23, 2021 

final rule opens another comment 

period instead of setting an effective 

date. 

Section 553 of the Administrative 

Procedure Act, 5 U.S.C. 553(b)(B), 

provides that, when an agency for good 

cause finds that notice and public 

procedure are impracticable, 

unnecessary, or contrary to the public 

interest, the agency may issue a rule 

without providing notice and an 

opportunity for public comment. EPA 

has determined that there is good cause 

for making this rule final without 

another prior proposal and opportunity 

for comment because, as explained here 

and in the explanation above, the 

change to the rule is a minor correction, 

it is noncontroversial in nature, and 

does not substantively change the 

requirements of West Virginia’s 

incorporation by reference of the 

NAAQS. Rather, the change sets the 

necessary effective date of this 

previously approved SIP revision. Thus, 

notice and opportunity for public 

comment are unnecessary. EPA finds 

that this constitutes good cause under 5 

U.S.C. 553(b)(B). 

Petitions for Judicial Review 

Under section 307(b)(1) of the CAA, 

petitions for judicial review of this 

action must be filed in the United States 

Court of Appeals for the appropriate 

circuit by May 23, 2022. Filing a 

petition for reconsideration by the 

Administrator of this final rule does not 

affect the finality of this action for the 

purposes of judicial review nor does it 

extend the time within which a petition 

for judicial review may be filed, and 

shall not postpone the effectiveness of 

such rule or action. 

This action, approving a correction to 

the West Virginia SIP revision 

incorporating by reference the NAAQS 

that previously appeared in the Federal 

Register on September 23, 2021 (86 FR 

52837), may not be challenged later in 

proceedings to enforce its requirements. 

(See section 307(b)(2).) 

List of Subjects in 40 CFR Part 52 

Environmental protection, Air 

pollution control, Incorporation by 

reference, Intergovernmental relations, 

Ozone, Reporting and recordkeeping 

requirements, Volatile organic 

compounds. 

Correction 

In the Federal Register of September 

23, 2021, 86 FR 52837, correct the DATES

to read: DATES: This final rule is 

effective on October 25, 2021. 

Dated: March 8, 2022. 

Diana Esher, 

Acting Regional Administrator, Region III. 

[FR Doc. 2022–06127 Filed 3–23–22; 8:45 am] 

BILLING CODE 6560–50–P 

DEPARTMENT OF HOMELAND 

SECURITY 

Coast Guard 

46 CFR Part 162 

RIN 1625–ZA42 

[Docket No. USCG–2019–0477] 

Final Policy Letter Describing TypeApproval Testing Methods for Ballast 

Water Management Systems (BWMS) 

That Render Organisms Nonviable in 

Ballast Water 

AGENCY: Coast Guard, DHS. 

ACTION: Final policy; notification. 

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 typeapproval 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 


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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). 

2Available at https://www.merriam-webster.com/ 

dictionary/stain?src=search-dict-hed (last accessed 

01/31/2022). 

3Available at Generic Protocol for the 

Verification of Ballast Water Treatment Technology 

| Science Inventory | U.S. EPA (last accessed 03/31/ 

2021). 

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. 

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

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 SiteSpecific 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 


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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 typeapproval 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-PolicyLetter/. 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 typeapproval 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 typeapproval. 

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 


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4Environmental 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). 

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. 

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 typeapprovals. 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 UVbased 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 


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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 SiteSpecific 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 sitespecific 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 typeapproval 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 


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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 typeapproval 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 preexisting 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’’ typeapproval 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 


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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 typeapproval 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 typeapproval 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 growout 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. 


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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 typeapproval 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 typeapproval 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 typeapproval 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 typeapproval 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 viabilitybased 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 


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5Available at https://www.merriam-webster.com/ 

dictionary/stain?src=search-dict-hed (last accessed 

01/31/2022). 

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 typeapproval 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 typeapproval 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 typeapproval 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. 

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 


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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 onboard 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 lowenergy 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 NEPAcompliant 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 typeapproval regulations, including methods 


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Federal Register / Vol. 87, No. 57 / Thursday, March 24, 2022 / Rules and Regulations 16651 

6https://www.dhs.gov/sites/default/files/ 

publications/DHS_Instruction%20Manual%20023- 

01-001-01%20Rev%2001_

508%20Admin%20Rev.pdf. 

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. 

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-PolicyLetter/. 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 


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