17254 Federal Register / Vol. 77, No. 57 / Friday, March 23, 2012 / Rules and Regulations 

DEPARTMENT OF HOMELAND 

SECURITY 

Coast Guard 

33 CFR Part 151 

46 CFR Part 162 

[Docket No. USCG–2001–10486] 

RIN 1625–AA32 

Standards for Living Organisms in 

Ships’ Ballast Water Discharged in 

U.S. Waters 

AGENCY: Coast Guard, DHS. 

ACTION: Final rule. 

SUMMARY: The Coast Guard is amending 

its regulations on ballast water 

management by establishing a standard 

for the allowable concentration of living 

organisms in ships’ ballast water 

discharged in waters of the United 

States. The Coast Guard is also 

amending its regulations for engineering 

equipment by establishing an approval 

process for ballast water management 

systems. These new regulations will aid 

in controlling the introduction and 

spread of nonindigenous species from 

ships’ ballast water in waters of the 

United States. 

DATES: This final rule is effective June 

21, 2012 except for 33 CFR 151.1513 

and 151.2036 which contains 

information collection requirements that 

OMB has not approved. The Coast 

Guard will publish a document in the 

Federal Register announcing the 

effective date. Comments sent to the 

Office of Management and Budget 

(OMB) on collection of information 

must reach OMB on or before May 22, 

2012. The incorporation by reference of 

certain publications listed in the rule is 

approved by the Director of the Federal 

Register on June 21, 2012. 

ADDRESSES: Comments and material 

received from the public, as well as 

documents mentioned in this preamble 

as being available in the docket, are part 

of docket USCG–2001–10486 and are 

available for inspection or copying at 

the Docket Management Facility (M–30), 

U.S. Department of Transportation, 

West Building Ground Floor, Room 

W12–140, 1200 New Jersey Avenue SE., 

Washington, DC 20590, between 9 a.m. 

and 5 p.m., Monday through Friday, 

except Federal holidays. You may also 

find this docket on the Internet by going 

to http://www.regulations.gov, inserting 

USCG–2001–10486 in the ‘‘Keyword’’ 

box, and then clicking ‘‘Search.’’ 

Collection of Information Comments. 

If you have comments on the collection 

of information discussed in section 

VII.D of this final rule, you must send 

comments to the Office of Information 

and Regulatory Affairs (OIRA), OMB. To 

ensure that OIRA receives your 

comments on time, you should submit 

your comments through the preferred 

methods of email to 

oira_submission@omb.eop.gov (include 

the docket number and ‘‘Attention: Desk 

Officer for Coast Guard, DHS’’ in the 

subject line of the email) or fax at 202– 

395–6566. An alternate, though slower, 

method is by U.S. mail to the OIRA, 

OMB, 725 17th Street NW., Washington, 

DC 20503, Attn: Desk Officer, U.S. Coast 

Guard. 

Viewing incorporation by reference 

material. You may inspect the material 

incorporated by reference at U.S. Coast 

Guard Headquarters, 2100 2nd St. SW., 

Washington, DC 20593 between 9 a.m. 

and 5 p.m., Monday through Friday, 

except Federal holidays. The telephone 

number is 202–372–1433. Copies of the 

material are available as indicated in the 

‘‘Incorporation by Reference’’ section of 

this preamble. 

FOR FURTHER INFORMATION CONTACT: If 

you have questions on this rule, call or 

email Mr. John Morris, Project Manager, 

U.S. Coast Guard; telephone 202–372– 

1433, email John.C.Morris@uscg.mil. If 

you have questions on viewing or 

submitting material to the docket, call 

Renee V. Wright, Program Manager, 

Docket Operations, telephone 202–366– 

9826. 

SUPPLEMENTARY INFORMATION: 

Table of Contents for Preamble 

I. Abbreviations 

II. Regulatory History 

III. Basis and Purpose 

IV. Background 

V. Discussion of Comments and Changes 

A. Summary of Changes From the NPRM 

1. Deferral of Phase-Two Standard 

2. Practicability Reviews 

3. Applicability 

4. COTP Zone Exemption 

5. Removal of Ballast Water Reporting 

Form From CFR 

6. Adoption of ETV Protocol 

7. Alternate Management Systems and 

Foreign Approvals 

8. Delay of Compliance Date for New 

Vessels 

9. Other Changes 

B. Discussion of Comments 

1. Applicability 

2. Ballast Water Discharge Standard 

3. Ballast Water Management Systems 

4. Type-Approval Protocols 

5. Legal 

6. Regulatory Analysis and Initial 

Regulatory Flexibility Analysis 

7. Draft Programmatic Environmental 

Impact Statement 

8. Beyond the Scope 

VI. Incorporation by Reference 

VII. Regulatory Analyses 

A. Regulatory Planning and Review 

B. Small Entities 

C. Assistance for Small Entities 

D. Collection of Information 

E. Federalism 

F. Unfunded Mandates Reform Act 

G. Taking of Private Property 

H. Civil Justice Reform 

I. Protection of Children 

J. Indian Tribal Governments 

K. Energy Effects 

L. Technical Standards 

M. Environment 

I. Abbreviations 

APA Administrative Procedure Act 

APHIS U.S. Department of Agriculture’s 

Animal and Plant Health Inspection 

Service 

AMS alternate management system 

BWDS ballast water discharge standard(s) 

BWE ballast water exchange 

BWM ballast water management 

BWMS ballast water management system(s) 

cfu colony forming unit(s) 

COTP Captain of the Port 

CSLC California State Lands Commission 

DPEIS Draft Programmatic Environmental 

Impact Statement 

DSA Danish Shipowners’ Association 

EEZ U.S. Exclusive Economic Zone 

EIS Environmental Impact Statement 

EPA U.S. Environmental Protection Agency 

ESA Endangered Species Act 

ETV Environmental Technology 

Verification 

FIFRA Federal Insecticide, Fungicide, and 

Rodenticide Act 

FPEIS Final Programmatic Environmental 

Impact Statement 

FR final rule 

GRT gross register tons 

GSI Great Ships Initiative 

GT gross tons 

IEC International Electrotechnical 

Commission 

IL Independent Laboratory 

IMO International Maritime Organization 

IRFA Initial Regulatory Flexibility Analysis 

ISO International Organization for 

Standardization 

ITC International Convention on Tonnage 

Measurement of Ships, 1969 

MSC Marine Safety Center 

NANPCA Nonindigenous Aquatic Nuisance 

Prevention and Control Act of 1990 

NARA National Archives and Records 

Administration 

NBIC National Ballast Information 

Clearinghouse 

NEPA National Environmental Policy Act 

NFPA National Fire Protection Association 

NIS nonindigenous species 

NISA National Invasive Species Act of 1996 

NPDES National Pollutant Discharge 

Elimination System 

NPRM notice of proposed rulemaking 

NRC National Research Council 

OPA Oil Pollution Act of 1990, as amended 

OMB Office of Management and Budget 

PEIS Programmatic Environmental Impact 

Statement 

PVA population viability analysis 

PSU practical salinity unit 

PWS RCAC Prince William Sound Regional 

Citizens’ Advisory Council 

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Federal Register / Vol. 77, No. 57 / Friday, March 23, 2012 / Rules and Regulations 17255 

1Copies of these studies are available in Docket 

No. USCG–2001–10486, and were available during 

the comment period following publication of the 

NPRM for this rulemaking. Please see ADDRESSES

section of this rulemaking for accessibility 

information. 

2 46 U.S.C. 391a stated ‘‘(3) Rules and 

regulations[.] In order to secure effective provision 

(A) for vessel safety, and (B) for protection of the 

marine environment, the Secretary of the 

department in which the Coast Guard is operating 

* * * shall establish for the vessels to which this 

section applies such additional rules and 

regulations as may be necessary with respect to the 

design and construction, alteration, repair, and 

maintenance of such vessels, including, * * * 

equipment * * * .’’ The Coast Guard determined 

that the use of ILs for witnessing or performing 

certain tests was ‘‘necessary’’ to carry out its 

responsibilities under this statutory section. In the 

NPRM proposing 46 CFR part 159, the Coast Guard 

explained that ‘‘the Coast Guard’s marine 

inspection responsibilities increased while the 

number of personnel available to perform these 

inspections has not increased at a comparable rate.’’ 

(43 FR 49440, Oct. 23, 1978). The Coast Guard 

promulgated part 159 to ‘‘free some of the Coast 

Guard’s limited field personnel for other duties 

with no change in the quality of the approved 

equipment or material.’’ Id.; see also 44 FR 73038 

(December 17, 1979) (Final rule document 

promulgating part 159). 

RA Regulatory Analysis 

ROS reduced operating status 

SAB Science Advisory Board 

SBA Small Business Administration 

SNPRM supplemental notice of proposed 

rulemaking 

STEP Shipboard Technology Evaluation 

Program 

UV ultraviolet radiation 

VGP Vessel General Permit 

VHS Viral Hemorrhagic Septicemia 

II. Regulatory History 

On August 28, 2009, the Coast Guard 

published a notice of proposed 

rulemaking (NPRM) entitled ‘‘Standards 

for Living Organisms in Ships’ Ballast 

Water Discharged in U.S. Waters’’ in the 

Federal Register (74 FR 44632). In 

response, we received 662 letters to the 

docket for the rulemaking, which 

contained 2,214 individual comments 

on the NPRM. We summarize these 

comments in the preamble of this final 

rule (see V.B. Discussion of Comments). 

We held six public meetings on the 

NPRM in the following locations: 

Seattle, WA; New Orleans, LA; Chicago, 

IL; Washington, DC; Oakland, CA; and 

New York, NY. Comments received at 

those meetings, both written and oral, 

are also summarized in this preamble 

(see V.B. Discussion of Comments). 

III. Basis and Purpose 

The Nonindigenous Aquatic Nuisance 

Prevention and Control Act of 1990 

(NANPCA), as amended by the National 

Invasive Species Act of 1996 (NISA), 

requires the Secretary of Homeland 

Security to ensure to the maximum 

extent practicable that aquatic nuisance 

species are not discharged into waters of 

the United States from vessels. 16 U.S.C. 

4711(c)(2)(A). The statutes further 

stipulate that the Secretary may approve 

the use of certain alternative ballast 

water management (BWM) methods if 

she determines that those alternative 

methods are at least as effective as 

ballast water exchange (BWE) in 

preventing and controlling infestations 

of aquatic nuisance species. 16 U.S.C. 

4711(c)(2)(D)(iii). The Secretary is 

further required to direct vessels to 

carry out management practices 

necessary to reduce the probability of 

unintentional discharges resulting from 

ship operations other than ballast water 

discharge. 16 U.S.C. 4711(c)(2)(E). 

NISA also requires the Secretary to 

assess and, if dictated by that 

assessment, to revise the Department’s 

BWM regulations not less than every 3 

years based on the best scientific 

information available to her at the time 

of that review, and potentially to the 

exclusion of some of the BWM methods 

listed at 16 U.S.C. 4711(c)(2)(D). 16 

U.S.C. 4711(e). The Commandant of the 

Coast Guard carries out these functions 

and authorities for the Secretary 

pursuant to a delegation of authority 

charging the Coast Guard with 

establishing and enforcing regulations to 

prevent the introduction and spread of 

aquatic nuisance species in the waters 

of the United States through the ballast 

water of vessels. Department of 

Homeland Security Delegation No. 

0170.1(II.)(57). 

Determining whether an alternative 

method of BWM is as effective as BWE 

is not an easy task. Results from several 

studies have shown the effectiveness of 

BWE varies considerably and is 

dependent on vessel type (design), 

exchange method, ballasting system 

configuration, exchange location, and 

method of study. These variables make 

comparing the effectiveness of an 

alternative BWM method to the 

effectiveness of BWE extremely 

difficult. Some studies suggest that the 

efficacy of BWE in reducing organism 

concentration is 80 to 99 percent per 

event (Hines and Ruiz 2000; Rigby and 

Hallegraeff 1993; Smith et al. 1996; 

Taylor and Bruce 2000; Zhang and 

Dickman 1999) although lower 

efficacies have been reported (e.g., 

Dickman and Zhang 1999). Other 

studies demonstrate that the volumetric 

efficiency of BWE ranges from 50 to 90 

percent (Battelle 2003; USCG 2001; 

Zhang and Dickman 1999).1 Thus, 

vessels with very large starting 

concentrations of organisms in their 

ballast tanks might still have large 

concentrations of organisms after BWE. 

In addition, a significant number of 

vessels are constrained by design or 

route from conducting BWE in 

compliance with existing regulations 

prior to their arrival into waters of the 

United States. 

For these reasons, BWE is not wellsuited as the basis for the protective 

BWM programmatic regimen envisioned 

by NISA, even though it has been a 

useful interim management practice and 

was a logical place to start. We have 

concluded that, as an alternative 

method to using BWE as the benchmark, 

establishing a standard for the 

concentration of living organisms that 

can be discharged in ballast water will 

advance the protective intent of NISA 

and simplify the process for Coast 

Guard approval of ballast water 

management systems (BWMS). We have 

found no other reasonable 

benchmarking approach. 

We have further concluded, through 

analysis of BWMS on vessels enrolled or 

being reviewed for the Coast Guard 

Shipboard Technology Evaluation 

Program (STEP) and other information 

before the Coast Guard which is in the 

docket for this rulemaking, in 

accordance with the factors set forth in 

151.1511(c) and 151.2030(c) of this final 

rule, that the specific ballast water 

discharge standard (BWDS) set forth in 

this rule is practicable. 

Setting a BWDS promotes the 

development of innovative BWM 

technologies, facilitates enforcement of 

the BWM regulations, and assists in 

evaluating the effectiveness of the BWM 

program. Therefore, in this rule, we 

amend 33 CFR part 151 by establishing 

a BWDS. We also amend 46 CFR part 

162 by adding an approval process for 

BWMS intended for use onboard vessels 

to meet the BWDS. 

As part of that approval process, the 

Coast Guard will require the use of 

Independent Laboratories (ILs) to 

perform the testing to be used to support 

applications for approval. The Coast 

Guard has a long history of recognizing 

the qualifications of ILs working under 

our oversight. In 1979, the Coast Guard 

promulgated 46 CFR part 159, 

establishing procedures and standards 

for accepting ILs for witnessing or 

performing certain tests and conducting 

inspections for certain equipment and 

materials requiring Coast Guard 

approval. 44 FR 73038 (December 17, 

1979). The Coast Guard promulgated 46 

CFR part 159 under the authority in 46 

U.S.C. 391a (1976) (Vessels carrying 

certain cargoes in bulk).2 In 1983, 

Congress revised and recodified the 

maritime laws of the United States and 

moved the relevant authority for 46 CFR 

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17256 Federal Register / Vol. 77, No. 57 / Friday, March 23, 2012 / Rules and Regulations 

3Section 3306 directs ‘‘the Secretary shall 

prescribe necessary regulations to ensure proper 

execution of, and to carry out, this part [addressing 

inspection and regulation of vessels] in the most 

effective manner for (1) The design, construction, 

alteration, repair, and operation of those vessels 

[subject to inspection] * * *; (2) lifesaving 

equipment and its use; (3) firefighting equipment, 

its use, and precautionary measures to guard against 

fire; (4) inspections and tests related to paragraphs 

(1), (2), and (3) of this subsection; and (5) the use 

of vessel stores and other supplies of a dangerous 

nature * * *.’’ 

part 159 to new 46 U.S.C. 3306.3 Public 

Law 98–89 Partial Revision of Title 45, 

U.S.C. ‘‘Shipping’’; House Report No. 

98–338 (August 1, 1983), 1983 

U.S.C.C.A.N. 924, 952–53. 

The authority for current 46 CFR part 

159 is 46 U.S.C. 3306, which ‘‘contains 

broad authority to prescribe regulations 

for proper inspection and certification 

of vessels,’’ (House Report No. 98–338 

(August 1, 1983), 1983 U.S.C.C.A.N. 

924, 954–53), including the specific 

requirement to prescribe regulations to 

carry out the statutory requirements ‘‘in 

the most effective manner,’’ (46 U.S.C. 

3306(a)). The Coast Guard still finds the 

use of ILs in the Coast Guard’s approval 

process to be ‘‘the most effective 

manner’’ of executing and carrying out 

its obligations under section 3306. 

IV. Background 

A full discussion of the legislative and 

regulatory history of the Coast Guard’s 

actions to implement both NANPCA 

and NISA may be found in the NPRM 

for this rule, published on August 28, 

2009. 74 FR 44632, 44633. 

Vessels subject to today’s final rule 

are also subject to the U.S. 

Environmental Protection Agency (EPA) 

Vessel General Permit (VGP) issued 

under section 402 of the Clean Water 

Act. The Coast Guard and EPA continue 

to work closely together in the 

development of ballast water discharge 

standards and to harmonize 

requirements, to the extent feasible and 

appropriate, under their respective 

statutory mandates. Under the CWA, 

EPA proposed the new draft VGP for 

public comment on November 30, 2011, 

with a proposed effective date of 

December 2013. 

The draft EPA VGP contains discharge 

limits for a number of discharges 

incidental to the normal operation of 

vessels operating in a capacity as a 

means of transportation, including 

numeric limits for ballast water 

discharges. The Coast Guard notes that 

the draft VGP proposes to apply 

numeric treatment limits for ballast 

water discharges to a broader class of 

vessels than this final rule. Like the 

2008 VGP, the draft 2013 VGP proposes 

some requirements that are broader in 

applicability, require additional 

management requirements, and require 

differing monitoring or other quality 

control requirements from today’s 

rulemaking. The 2008 VGP applied 

requirements to tankers in the coastwise 

trade and required ballast water 

exchange for vessels engaged in Pacific 

nearshore voyages, among other ballast 

water requirements that differed from 

the Coast Guard regulation in effect in 

2008. The Coast Guard notes that EPA 

must consider the information in its 

record, as well as the requirements of 

the Clean Water Act, as it finalizes the 

VGP. Therefore, it is possible that the 

final VGP will contain requirements that 

differ from those found in our 

rulemaking today. 

For more information on EPA’s 

current VGP or its next draft VGP, visit 

the EPA’s Web site at: http:// 

www.epa.gov/npdes/vessels. Nothing in 

this final rule is intended to limit, in 

any way, actions the EPA may take in 

the future with respect to regulation of 

ballast water discharge in the EPA VGP 

under its Clean Water Act authorities. 

See, e.g., 16 U.S.C. 4711(b)(2)(C) and 

4711(c)(2)(J). 

V. Discussion of Comments and 

Changes 

A. Summary of Changes From the 

NPRM 

This final rule contains a number of 

changes from the rule proposed by the 

NPRM (74 FR 44632 (August 28, 2009)). 

While we list in this section all changes 

made to the rule since the NPRM, we 

are highlighting several of these changes 

not only because they are important, but 

also because a vast majority of the 

comments received in the docket 

addressed at least one of these topics. 

Most of the changes discussed below 

were made directly in response to those 

comments. A full discussion of 

comments and Coast Guard responses is 

found in section V.B. Discussion of 

Comments. 

1. Deferral of Phase-Two Standard 

Most notably, this final rule does not 

include the NPRM’s proposed phasetwo standard. This reflects a decision to 

move forward with the phase-one 

standard while the Coast Guard 

continues to assess the practicability of 

implementing a phase-two standard, 

gathers additional data on technology 

available to meet the phase-two 

standard for various vessel types, and 

develops a subsequent rule with an 

economic and environmental analysis to 

support a phase-two standard. The 

decision to remove this more stringent 

standard from this final rule should not 

be interpreted as a sign that the Coast 

Guard is not committed to its statutory 

responsibility to continually review the 

BWDS to increase the protectiveness of 

the BWDS. 

Significantly, after this final rule was 

drafted, the EPA requested its Science 

Advisory Board (SAB) to review and 

provide advice regarding whether 

existing shipboard treatment 

technologies can reach specified 

concentrations of organisms in vessel 

ballast water, how these technologies 

might be improved in the future, and 

how to overcome limitations in existing 

data (EPA SAB 2011). Information was 

identified on 51 existing or 

developmental ballast water treatment 

technologies, although detailed data 

were available for only 15 specific 

BWMS. The SAB used this information 

as the source material for its assessment 

of ballast water treatment performance 

and, as requested by the EPA, used 

proposed ballast water discharge 

standards as the performance 

benchmarks. Based on its evaluation of 

the available data, the SAB concluded 

that the performance standards for 

discharge quality proposed by IMO and 

the Coast Guard are currently 

measurable, based on data from landbased and shipboard testing. However, 

current methods (and associated 

detection limits) prevent testing of 

BWMS to any standard more stringent 

than D–2/Phase 1 and make it 

impracticable for verifying a standard 

100 or 1,000 times more stringent. New 

or improved methods will be required to 

increase detection limits sufficiently to 

statistically evaluate a standard 10 times 

more stringent than IMO D–2/Phase 1; 

such methods may be available in the 

near future. The SAB concluded that 

establishment of a ballast water 

discharge limit at the proposed Coast 

Guard Phase I/IMO discharge standard 

will result in a substantial reduction in 

the concentration of living organisms in 

the vast majority of ballast water 

discharges, compared to discharges of 

ballast water managed by mid-ocean 

exchange or discharges of unexchanged 

ballast water. The numeric limitations 

in today’s final rule represent the most 

stringent standards that BWMS 

currently safely, effectively, credibly, 

and reliably meet (US EPA SAB, 2011.) 

The cost, benefit, and environmental 

impact analyses included in the NPRM 

could not specifically assess all impacts 

related to the phase-two standard 

(although the analyses did include an 

evaluation of standards that are more 

stringent than the standard proposed 

herein as practicable). Many 

commenters addressed this issue, noting 

that the lack of analyses made it 

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Federal Register / Vol. 77, No. 57 / Friday, March 23, 2012 / Rules and Regulations 17257 

impossible for them to comment on the 

phase-two standard in any meaningful 

manner. 

To provide the public with as much 

information as possible on which to 

base comments, the Coast Guard will 

develop additional analyses regarding 

the potential costs, benefits, and 

environmental impacts of the proposed 

phase-two standard or any standard 

higher than phase-one. When these 

analyses are completed, the Coast Guard 

will make them available for public 

comment, either via a notice of 

availability or in conjunction with a 

subsequent rulemaking published in the 

Federal Register. 

The Coast Guard still fully intends to 

issue a later rule that will establish a 

more stringent phase-two discharge 

standard once the additional research 

and analysis necessary to support this 

more stringent standard has been 

completed. To demonstrate our 

commitment, in the final rule text we 

are reserving the regulatory provisions 

where the phase-two standard will be 

found, to show that the Coast Guard 

does not view publication of this rule as 

completing the agency’s work in 

controlling the introduction and spread 

of NIS from ships’ ballast water. 

2. Practicability Reviews 

The NPRM proposed an initial 

practicability review to be published at 

least 3 years prior to the first 

compliance date under the BWDS 

implementation schedule, with a 

subsequent review no later than 2 years 

after the initial review. Because we have 

removed the phase-two standard from 

this final rule, we have also removed the 

recurring practicability reviews that 

were included in the NPRM. This final 

rule establishes clearer guidelines and 

criteria considered for the practicability 

review. Additionally, because the final 

rule defers establishing a phase-two 

standard, we wanted to prevent the 

scenario in which a finalized phase-two 

standard believed to be practicable 

when established should not be 

implemented according to the 

established timelines, either because it 

can be implemented sooner or because 

it cannot be implemented by the 

deadline established. To accomplish 

this, NISA requires regular reviews and 

strengthening of standards when 

determined practicable, so completing a 

review will be part of any future 

rulemaking. See 16 U.S.C. 4711(e). 

This final rule does include one 

practicability review provision, which 

requires the Coast Guard to complete 

and publish the results of its 

practicability review no later than 

January 1, 2016. This review will draw 

a significant component of its 

information from the BWMS approval 

application packages that the Coast 

Guard expects to evaluate between the 

publication date of this final rule and 

the initial implementation date. The 

Coast Guard’s practicability review will 

look at a variety of factors, including but 

not limited to economic factors and the 

efficacy and environmental safety of 

available BWMS technology. While we 

have listed a number of these factors in 

this final rule, we have also included a 

provision allowing us to consider 

additional factors. This is to ensure that 

the Coast Guard is not foreclosed from 

considering any unforeseen issues. 

Some commenters argued against 

considering any factor other than best 

available technology. Whether the 

commenters meant ‘‘best available 

technology’’ as a term of art under the 

Clean Water Act or merely the best 

technology available in the marketplace, 

the Coast Guard acknowledges the 

importance of technology. However, the 

Coast Guard’s authority does not limit 

the matters of concern to technology. 

Congress established a practicability 

standard in NISA; that standard requires 

that the Coast Guard consider more than 

just technology. A standard based solely 

on technology would be inconsistent 

with the statute. 

3. Applicability 

In the NPRM, we proposed requiring 

vessels discharging ballast water into 

waters of the United States to comply 

with the BWDS. This included vessels 

operating solely in coastwise trade and 

on the internal waters of the United 

States. Those vessels are not required to 

conduct a BWE under the existing Coast 

Guard regulations, and, as such, the 

proposal was seen as an expansion of 

those regulations. A large number of 

commenters questioned this expansion. 

Commenters raised a number of issues 

regarding the applicability of the NPRM. 

These issues included uncertainty as to 

whether any of the currently available 

BWMS could be successfully installed 

on non-seagoing vessels, the cost of 

installation of BWMS on these 

industries, and the benefit of requiring 

these vessels to install a BWMS. 

As a result of these comments, this 

final rule applies to two groups of 

vessels discharging ballast water into 

waters of the United States. The first 

group is comprised of those vessels 

currently required to conduct BWE. The 

second group, which previously was not 

required to conduct BWE, is comprised 

of seagoing vessels that do not operate 

beyond the U.S. Exclusive Economic 

Zone (EEZ), that take on and discharge 

ballast water in more than one Captain 

of the Port (COTP) Zone, and are greater 

than 1,600 gross register tons (GRT) 

(3,000 gross tons (GT) International 

Tonnage Convention (ITC)). 

The Coast Guard fully intends to 

expand the applicability of the BWDS to 

all vessels not legislatively exempted 

that operate in U.S. navigable waters or 

territorial sea, as we proposed in the 

NPRM, but we have determined that 

additional analysis is necessary to 

support this expansion. We also intend 

to conduct additional research as 

necessary. We expect that this 

expansion will be part of the notice or 

other rulemaking document that 

addresses the phase-two standard, and 

that vessels covered by the expanded 

applicability will be required to install 

a BWMS that meets at least the phaseone standard. 

In addition to the comments on 

applicability mentioned above, we also 

received comments questioning why we 

proposed using the presence of ballast 

tanks as the main applicability factor for 

BWMS installation, instead of the actual 

discharge of ballast water. We agree an 

important factor in deciding whether a 

vessel is required to have a BWMS 

onboard should be the threat that vessel 

presents to contributing to the threat of 

aquatic NIS. Vessels that pose a low 

level of risk, either because they do not 

discharge ballast water at all, discharge 

only to shoreside facilities, or discharge 

only water that presents little threat 

(public drinking water), should not be 

required to install a BWMS. For this 

reason, we revised 33 CFR 151.1510 and 

151.2025 to (1) clarify that discharge of 

ballast water into waters of the U.S. is 

a threshold requirement for installation 

of a BWMS, and (2) include an 

additional BWM option for use of water 

from a U.S. public water supply meeting 

certain EPA drinking water standards. 

We have also slightly revised the 

applicability section in 33 CFR part 151 

subpart C (Ballast Water Management 

for Control of Nonindigenous Species in 

the Great Lakes and Hudson River). We 

inserted a provision to clearly state that 

all vessels subject to subpart C are also 

subject to 33 CFR part 151 subpart D 

(Ballast Water Management for Control 

of Nonindigenous Species in Waters of 

the United States). This does not reflect 

an actual change to the regulations, as 

the general applicability provision in 

subpart D already applies to vessels 

subject to subpart C. Subpart D requires 

that these vessels comply with 

additional NIS reduction practices and 

the reporting and recordkeeping 

requirements. We are adding the 

clarifying statement to subpart C in 

order to ensure there is no confusion 

about the applicability of subparts C and 

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17258 Federal Register / Vol. 77, No. 57 / Friday, March 23, 2012 / Rules and Regulations 

4EPA/600/R–10/146, version 5.1 (September 

2010). Available at http://www.epa.gov/nrmrl/pubs/ 

600r10146/600r10146.pdf. 

5See Int’l Union, United Mine Workers of Amer. 

v. Mine Safety and Health Admin., 626 F.3d 84, 95 

(D.C. Cir. 2010) (‘‘a final rule will be deemed to be 

the logical outgrowth of a proposed rule if a new 

round of notice and comment would not provide 

commenters with their first occasion to offer new 

and different criticisms which the agency might 

find convincing.’’) (internal citations omitted). 

D. We made other slight modifications 

to align the applicability section of 

subpart C with that of subpart D, but 

these revisions do not change the 

substantive requirements of either 

subpart. 

4. COTP Zone Exemption 

Existing BWM regulations include a 

provision that exempts owners and 

operators of vessels operating in only 

one COTP Zone from reporting and 

recordkeeping requirements. 33 CFR 

151.2010(b)(1). In the NPRM, we 

intended to remove this exemption from 

the reporting and recordkeeping 

requirements, but include an exemption 

from the BWDS for owners and 

operators of these vessels (those 

operating in only one COTP Zone). We 

explained this exemption by stating that 

‘‘it is unlikely that vessels operating in 

only one COTP Zone would introduce 

invasive species (from outside of that 

COTP Zone) into the waters of the COTP 

Zone.’’ 74 FR 44634. 

Unfortunately, the proposed 

regulatory text included erroneous cross 

references, did not actually exempt 

these vessels from the intended 

provisions, and did not remove the 

current reporting and recordkeeping 

exemption. This error confused many 

commenters. Other commenters based 

their comments on our intentions as 

stated in the preamble, and noted that 

COTP Zones are purely administrative 

in nature, not established based on any 

ecological or biological bases, and 

therefore are not appropriate boundaries 

to be used when addressing invasive 

species. 

Because we have revised the 

applicability of this final rule, as 

discussed above, the BWDS will not 

apply to vessels operating within only 

one COTP Zone. However, we do intend 

to expand the applicability of the BWM 

requirement to include all vessels 

operating in waters of the United States 

that are not legislatively exempted, but 

have determined that additional 

analysis is necessary to support such an 

expansion. We also intend to conduct 

additional research as necessary. The 

issue of whether there are distinct zones 

or areas where it might be appropriate 

to include an exemption for vessels that 

do not leave that zone or area is still 

open to consideration as part of a 

subsequent notice or other rulemaking 

document. 

Many commenters supported the 

concept of geographic exemptions; 

however, some objected to using COTP 

Zones as the basis for the exemption. 

For this reason, the Coast Guard will 

investigate other possible ways to create 

an exemption like this, using 

suggestions from commenters and our 

Federal agency partners. 

We are also keeping intact the current 

exemption from recordkeeping and 

reporting requirements for these vessels 

which operate exclusively in one COTP 

Zone. We will, in the future, begin a 

separate rulemaking project addressing 

BWM recordkeeping and reporting 

requirements, and any changes to this 

exemption will be addressed in that 

project. 

5. Removal of Ballast Water Reporting 

Form From CFR 

We have removed the Ballast Water 

Reporting Form (Office of Management 

and Budget (OMB) Control No. 1625– 

0069) from the appendix to 33 CFR part 

151 subpart D. This form is still the 

proper form to satisfy the reporting 

requirements in 33 CFR 151.2070. We 

have revised § 151.2070 to reference the 

National Ballast Information 

Clearinghouse (NBIC) Web site as the 

form’s location. This change will not 

have any effect on the public, as the 

form will still be available and the 

requirement for filing the form is not 

being revised. 

We have removed this form from the 

CFR in order to streamline future 

changes to the form. Any changes would 

need to comply with provisions of the 

Paperwork Reduction Act (44 U.S.C. 

3501 et seq.), which include providing 

notice to the public and opportunity for 

comment. Additionally, the form is part 

of an OMB-approved collection of 

information that must be renewed on a 

regular basis. These renewals also 

include an opportunity for public notice 

and comment on the form and the 

associated collection of information. 

6. Adoption of Environmental 

Technology Verification (ETV) Protocol 

In the NPRM, we noted that our 

proposed BWMS approval process was 

based, in part, on the draft Generic 

Protocol for the Verification of Ballast 

Water Treatment Technologies 

developed under EPA’s ETV Program. 

74 FR 44640 (Aug. 28, 2009). Since the 

publication of the NPRM, EPA has 

completed its development of this 

protocol, a process that included 

laboratory testing, stakeholder reviews, 

and public comment. The protocol may 

be found on the EPA Web site, under 

Research and Development, Risk 

Management Research Publications.4

The Coast Guard and EPA have been 

formal partners in the process of 

developing this protocol. It has always 

been our intention to incorporate the 

final ETV Protocol into our BWMS 

approval process, which we are doing 

via this final rule. 

While this incorporation was not part 

of the proposal included in the NPRM, 

we noted that the procedures in the 

NPRM were based on a preliminary 

version of the ETV Protocol (74 FR 

44634, 44640). While the final ETV 

Protocol differs from earlier versions, 

the differences are due both to 

consensus revisions during finalization 

of the protocol, and to subsequent peer 

review and public comments. Some of 

the comments we received on the NPRM 

specifically suggested that we use the 

final ETV Protocol. 

For all of these reasons, the Coast 

Guard has determined that 

incorporating the final ETV Protocol 

into this final rule is a logical outgrowth 

of what was proposed in the NPRM, and 

that further notice and comment on 

incorporating it by reference is not 

required.5 We have revised the approval 

process regulations to incorporate the 

final ETV Protocol, and have removed 

those portions of the regulation that 

were made redundant by this 

incorporation. 

7. Alternate Management System(s) 

(AMS) and Foreign Approvals 

The NPRM included a provision to 

allow foreign type-approved BWMS to 

receive U.S. type approval subject to an 

equivalency determination. We have 

removed that provision in this final 

rule; however, we still allow 

manufacturers to use testing done to 

obtain type approval from a foreign 

administration, and the data from that 

testing, to satisfy the U.S. type-approval 

testing and application requirements if 

the Coast Guard determines the testing 

to be equivalent to what is required by 

our regulation. The language in 46 CFR 

162.060–12 was revised; we have 

included more detail as to what a 

manufacturer with a foreign-approved 

BWMS must show in order to use their 

prior testing to satisfy our approval 

requirements, rather than vaguely 

calling for the manufacturer to show 

equivalency. Despite these revisions, the 

intent and effect of the changes are 

substantially similar to what appeared 

in the NPRM. As such, we view these 

changes as logical outgrowths of the 

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NPRM, and thus further notice and 

comment is not required. 

Despite the provision discussed in the 

previous paragraph, we are aware that 

many foreign-approved BWMS will 

require additional testing in addition to 

analysis under applicable U.S. 

environmental laws, such as the 

National Environmental Policy Act 

(NEPA) and the Endangered Species Act 

(ESA). This is due to differences 

between the international approval 

regime and the approval protocol 

adopted in the final rule. This will 

extend the amount of time required for 

foreign-approved systems to gain U.S. 

approval, although the process to secure 

U.S. approval should still be shorter 

than if the manufacturer were required 

to repeat all testing already completed 

for obtaining type approval from a 

foreign administration. 

Implementing the U.S. approval 

process will likely take at least 3 years. 

We do not anticipate having U.S. 

approved systems that have satisfied the 

testing protocols required in 46 CFR 

subpart 162.060 prior to 2015. 

To ensure there are BWMS available 

for vessel installation and use without 

having to delay the implementation 

schedule, and also to provide an 

incentive for the early installation and 

use of BWMS instead of relying 

exclusively on BWE, we have added a 

provision to 33 CFR 151.1510(a)(1), 

151.2025(a)(3), and included a new 

provision (§ 151.2026) and definition 

(§ 151.1504) to allow for the temporary 

acceptance of foreign-approved BWMS, 

providing the Coast Guard determines 

that the BWMS is at least as effective as 

BWE. These alternate management 

systems (AMS) must be approved by 

foreign governments under the 

standards set forth in the International 

Convention for the Control and 

Management of Ships Ballast Water and 

Sediments (IMO BWM Convention), 

after it enters into force, or consistent 

with relevant guidelines developed by 

the IMO. This provision for AMS will 

also allow vessels with BWMS installed 

to meet requirements of other 

administrations and/or the standards set 

forth in the IMO BWM Convention to 

use such BWMS while operating in 

waters of the United States. We further 

note that pursuant to § 151.2025(e) of 

this final rule, any vessel using an AMS 

must comply with the terms and 

conditions of the VGP when operating 

in U.S. waters, including any applicable 

discharge limitations. 

As with the process for U.S. approval 

of foreign-approved BWMS, these 

temporary acceptance determinations 

will be subjected to reviews under 

NEPA, ESA, and other environmental 

policy laws. However, we expect the 

AMS process will require less time than 

the more extensive type approval 

process, which will allow vessel owners 

to install BWMS prior to the 

implementation dates contained in the 

regulation. These earlier installations 

should result, at the earliest possible 

date, in a reduction of the risk of ballast 

water introducing or spreading NIS, as 

those vessels currently unable to 

conduct BWE due to safety concerns or 

voyage constraints will instead be 

subjecting their ballast water to some 

type of treatment before discharging it 

into the waters of the United States. 

Use of an AMS will be allowed for up 

to 5 years after the vessel is required to 

comply with the BWDS. The 5-year 

period should provide the manufacturer 

or vendor with sufficient time to obtain 

U.S. approval, either using the data from 

the tests already completed, or by 

undergoing new tests designed 

specifically to comply with 46 CFR part 

162.060. 

8. Delay of Compliance Date for New 

Vessels 

Even with the provision for 

acceptance of foreign type approvals, a 

process that is expected to be quicker 

than completing the full schedule of 

land-based and shipboard tests, we 

anticipate there will not be an adequate 

number of approved BWMS to allow 

vessel owners to meet the NPRM’s 

proposed compliance date for new 

vessels. For this reason, we have pushed 

back the compliance date for new 

vessels to install Coast Guard-approved 

BWMS from January 1, 2012, to 

December 1, 2013. Additionally, the 

December 1st date will align the 

compliance date with the proposed 

effective date for the 2013 EPA VGP. We 

estimate this deferral could delay the 

compliance date for up to 600 newly 

constructed vessels. 

We have also added a provision to 

both 33 CFR part 151 subparts C and D 

that will allow individual vessel owners 

to request that the Coast Guard extend 

their compliance date if, despite the 

owner’s efforts, he or she cannot meet 

the published compliance dates. This 

change is in response to commenters 

who argued that the compliance 

timelines included in the NPRM were 

too aggressive. 

9. Other Changes 

The Coast Guard made additional 

changes in response to comments, and 

some of those changes warrant a 

summary here. The remaining changes 

are listed at the end of this section and 

discussed further in section V.B. 

Discussion of Comments. 

First, we are adding a requirement to 

33 CFR 151.2075 for sampling ports on 

each of the vessel’s overboard ballast 

water discharge pipes. This change is a 

response to commenters who requested 

stronger enforcement and commenters 

who asked how enforcement would be 

achieved. Without the inclusion of 

sampling ports, Coast Guard inspectors 

would not be able to sample a vessel’s 

ballast water without potentially 

delaying the vessel for significant 

periods of time. Sampling is necessary 

in order to determine if the BWMS is 

operating properly to produce ballast 

water that meets the BWDS. The 

inclusion of sampling ports is logical 

outgrowth of the NPRM because the 

Coast Guard must have means to ensure 

compliance, and the NPRM included a 

provision requiring vessel owners and 

operators to provide access to the Coast 

Guard for sampling. Also, commenters 

asked how enforcement would be 

achieved. Inclusion of this requirement 

improves Coast Guard enforcement and 

responds to both groups of these 

commenters. 

Secondly, we received questions from 

commenters asking who should operate 

the BWMS during the shipboard testing. 

We have clarified in 46 CFR 162.060–28 

that it should be the vessel crew 

operating the BWMS. This is most 

appropriate because the crewmembers 

are the ones who will need to operate 

the BWMS after it receives U.S. type 

approval. Additionally, having the crew 

operate the BWMS ensures that vendors 

and manufacturers, who have a stake in 

the success of the BWMS, are not able 

to influence the test results. This 

provision is a logical outgrowth of the 

NPRM because the NPRM listed the 

vessel crew as one of two groups that 

should operate the BWMS during 

testing. This change is a clarification to 

show which of those listed entities 

should operate the BWMS during landbased testing, and which should operate 

the BWMS during shipboard testing. 

Finally, in response to comments, we 

reduced the time period required for 

shipboard testing from 12 months to 6 

months, removed the requirement for 

testing to be in three distinct geographic 

regions, and reduced the number of 

required, valid test cycles. Several 

commenters requested these changes, 

noting that our proposed requirements 

were unnecessary and too burdensome. 

We agree that the suggested changes 

will still provide for adequate shipboard 

testing of BWMS, therefore, we have 

made these changes to reduce the 

burden associated with shipboard 

testing. 

The remaining changes made in 

response to comments were replacing 

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the term ‘‘build date’’ with 

‘‘constructed’’, in order to better align 

with the IMO BWM Convention and 

updating the civil penalty amounts to 

reflect their adjustment in a recent Coast 

Guard final rule. 

The Coast Guard made several 

changes during the drafting of this final 

rule to eliminate redundancy and 

streamline the regulatory text. We 

revised the definitions section in 33 

CFR part 151 subpart D by removing 

those definitions that are already 

defined in part 151 subpart C, as well 

as definitions for terms not used in part 

151 subpart D. We added definitions for 

several terms that were used in 46 CFR 

subpart 162.060, and we updated the 

incorporation by reference section in 

that subpart to more clearly indicate 

those standards being incorporated into 

this regulation. 

We deleted 33 CFR 151.2075(c), 

which referred to an assessment of 

vessel compliance with the now 

obsolete voluntary national program. 

That assessment has been completed for 

several years; therefore, it is no longer 

necessary to refer to it in the 

regulations. 

We revised § 151.1510(a)(1) to clarify 

when BWE must be conducted. We also 

revised paragraphs (a)(3) and (d) of that 

section to improve readability and 

clarify requirements. Similar revisions 

were made in § 151.2025, also to 

improve readability and clarify 

requirements. 

We corrected the BWDS in both 

subparts C and D to align with the IMO 

BWM Convention. 

We removed proposed 33 CFR 

151.2045 ‘‘Safety exceptions,’’ as we 

determined that those provisions were 

largely repetitive to what was proposed 

in 33 CFR 151.2040, entitled ‘‘Discharge 

of ballast water in extraordinary 

circumstances.’’ We moved the one nonrepetitive provision to § 151.2040. As a 

result, § 151.2040 now includes the 

provision noting that nothing in the 

regulations relieves the master, owner, 

agent, or person in charge of the vessel 

from any responsibility, including the 

safety and stability of the vessel and the 

safety of the crew and passengers. 

Throughout the regulatory text, we 

updated addresses for the Coast Guard 

Marine Safety Center, also adding in an 

email address option. We updated crossreferences where necessary, and made 

changes to remove passive tense from 

the requirements. These changes 

improve the readability of the 

regulation, and clarify requirements. 

We made a number of non-substantive 

changes to the approval procedures 

found in 46 CFR subpart 162.060. Like 

many of the changes we are making, 

these changes improve the readability of 

the regulation, and clarify requirements. 

We also revised the regulatory text that 

was proposed in 46 CFR 162.060–40. In 

the NPRM, that section included all 

requirements for ILs. In this final rule, 

we have split those requirements into 

two sections (46 CFR 162.060–40 and 

162.060–42). The first section includes 

requirements for ILs applying for Coast 

Guard designation; the second section 

now contains the responsibilities 

imposed on ILs once they are designated 

by the Coast Guard. 

These changes result in more easily 

understandable regulations, but do not 

make substantive changes. For this 

reason, the Coast Guard has determined 

that further notice and comment on the 

changes is unnecessary, pursuant to 

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

B. Discussion of Comments 

We received 662 comment letters on 

our NPRM, which contained 2,214 

individual comments. We have divided 

our discussion of these comments into 

subject matter topics, and our responses 

are laid out in the following sections. 

1. Applicability 

One hundred and thirty four 

commenters addressed the applicability 

of the proposed regulations. Of these, 39 

requested an exemption based on the 

segment of industry in which their 

vessel is engaged. These industry 

segments include: towing vessels and 

barges; offshore energy services support 

vessels; commercial fishing vessels; 

passenger vessels; offshore floating 

platforms; and vessels operating solely 

in the Great Lakes. 

Many commenters generally criticized 

the application of the BWDS to their 

specific type of vessel. Forty eight 

commenters stated that various aspects 

of the design or operation of their 

vessels make it infeasible for them to 

practicably install a BWMS. The cited 

constraints include lack of space, lack of 

ballast piping, insufficient power 

available onboard, independent pumps 

and piping for each tank, insufficient 

BW holding times and pumping 

capacities in excess of current BWMS 

capabilities. 

As we have discussed in this 

preamble, we have revised the 

applicability of this final rule so that the 

BWM requirements primarily apply to 

vessels with ballast tanks operating in 

waters of the United States after having 

operated outside of the EEZ (see V.B. 

Summary of Changes from the NPRM). 

Certain other vessels that operate 

exclusively in the EEZ and in more than 

one COTP Zone, and that meet certain 

size thresholds that make them similar 

to vessels operating on international 

routes are also required to comply. The 

Coast Guard, however, intends to 

expand this applicability in the near 

future after further study and will keep 

these commenters’ requests in mind. We 

have also added, as discussed above, a 

provision for vessel owners who are 

required to comply with the BWDS but 

cannot do so for good reason (such as 

design and operating conditions or 

unavailability of systems) to request a 

delay in their compliance date. 

Vessels Operating Solely in the Great 

Lakes 

Twenty one commenters asked that 

vessels operating solely in the Great 

Lakes be treated differently from 

seagoing vessels due to the constraints 

cited above. Those commenters also 

requested that they be allowed to 

continue the best management practices 

currently in place instead of being 

required to install BWMS. 

Conversely, 35 commenters urged the 

Coast Guard to regulate vessels 

operating solely in the Great Lakes. Five 

commenters asked the Coast Guard to 

hold vessels operating solely in the 

Great Lakes to the most stringent BWDS 

possible. One of these commenters 

submitted a petition with 8,905 

individual signatures in support of 

stronger regulation of vessels that 

operate exclusively in the Great Lakes. 

One commenter supported regulating 

vessels operating solely in the Great 

Lakes but felt the regulatory priority 

should be on preventing introductions 

of aquatic NIS by oceangoing vessels. 

Two commenters supported expanded 

regulation of vessels operating solely in 

the Great Lakes, but asked that the 

regulations take into account the unique 

design and operating characteristics of 

these vessels. Twenty seven additional 

commenters supported regulating this 

vessel population without providing a 

specific reason. 

For the reasons we have discussed in 

this preamble, we are not requiring 

vessels that operate exclusively in the 

Great Lakes to comply with the BWDS 

in this final rule (see V.B. Summary of 

Changes from the NPRM). The Coast 

Guard intends to re-examine this 

decision in the near future, and will 

keep these commenters’ requests in 

mind when developing subsequent 

rulemakings. 

Municipal Water as Ballast 

Twenty commenters urged the Coast 

Guard to exempt vessels from having to 

treat their ballast water if the water was 

obtained from a municipal water 

supply, as they believe this poses little 

risk of introducing or spreading NIS in 

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waters of the United States. The 

commenters stated that this is a 

common practice for inland towing 

vessels and/or barges, offshore energy 

services, and small business interests, 

and is authorized under existing Coast 

Guard policy. 

Fifteen commenters proposed that 

vessels should be allowed to use 

municipal or potable water for ballast 

water. These commenters also proposed 

that vessels should be permitted to 

discharge that water into waters of the 

United States without having to use a 

Coast Guard-approved BWMS or to meet 

the BWDS. 

The Coast Guard agrees that, in some 

situations, ballast water does not pose a 

significant threat of introducing or 

spreading NIS. We have some concerns 

about the variable quality of municipal 

water sources, but believe that water 

that satisfies the standards of the Safe 

Drinking Water Act (42 U.S.C. 300f– 

300j) should be acceptable for use as 

ballast water without posing a 

significant threat of introducing or 

spreading NIS. As a result, we have 

revised the regulation to allow for use 

of water from a U.S. public water system 

(PWS) meeting the requirements of the 

Safe Drinking Water Act as an 

alternative to installing a BWMS 

meeting the BWDS. We note, however, 

that with the exception of PWS water 

used under extraordinary circumstances 

in accordance with 33 CFR 151.1515, a 

vessel must exclusively use PWS water 

as ballast. Any mixture of water 

obtained from a source other than a 

facility meeting the requirements of the 

Safe Drinking Water Act will negate 

acceptability of water from a PWS as 

discharged ballast water. This change is 

found in 33 CFR 151.1510(a)(4) and 

151.2025(a)(2). 

COTP Zones 

Seven commenters urged the Coast 

Guard to not grant regulatory 

exemptions for vessels operating 

exclusively in a single COTP Zone. 

They noted that these zones are not 

ecologically meaningful subdivisions 

and asked that any boundaries be based 

on scientific analysis of the risk of 

transferring invasive NIS. 

Conversely, 17 commenters urged the 

Coast Guard to provide exemptions for 

vessels that operate exclusively in a 

single COTP Zone or conduct all ballast 

operations in a single COTP Zone. They 

argued that these practices would pose 

minimal environmental risk. 

Four commenters requested a 

correction to the regulatory text to 

ensure that the proposed exemption for 

vessels operating exclusively in one 

COTP Zone (33 CFR 151.2015) extends 

to the BWM requirements (33 CFR 

151.2025), consistent with the 

description of this provision in the 

preamble to the NPRM. One commenter 

called for the Coast Guard to continue 

to exclude vessels operating exclusively 

within one COTP Zone from the 

requirement to meet the BWDS. 

For the reasons discussed earlier in 

this preamble, the BWM provisions of 

this final rule will not apply to vessels 

operating exclusively in a single COTP 

Zone (see V.A. Summary of Changes 

from the NPRM). The issue of whether 

there are distinct zones or areas other 

than COTP Zones where it might be 

appropriate to include an exemption for 

vessels that do not leave that zone or 

area remains open to consideration. The 

Coast Guard will investigate other 

possible ways to craft a geographic 

exemption, using suggestions from 

commenters and our Federal agency 

partners. The Coast Guard has 

determined that, for now, this is the best 

applicability delineation for the 

regulation based upon the available 

information and the Coast Guard’s 

needs in effectively administering the 

ballast water program. The Coast Guard 

intends to re-examine this decision in 

the near future, and we will keep these 

commenters’ requests in mind as we 

develop subsequent rules. 

This rulemaking project has 

highlighted the need for additional 

research and analysis for ballast water 

regulatory efforts. A primary source of 

data for this research and analysis is the 

Ballast Water Reporting Form (available 

on the NBIC Web site at http:// 

invasions.si.edu/nbic/submit.html), 

which vessels operating exclusively 

within a single COTP Zone are currently 

exempted from completing. In the 

future, the Coast Guard may initiate a 

separate rulemaking to expand the 

number of vessels submitting ballast 

water reports so that we can meet the 

statutory requirements for maintaining a 

clearinghouse on national ballast water 

data, and to collect additional data for 

use both in future regulations, and in 

future practicability reviews. 

Great Lakes and Gulf of Mexico 

Ecosystems 

Twenty two commenters urged the 

Coast Guard to designate the waters of 

the Ninth Coast Guard District as a 

single COTP Zone and exempt vessels 

operating exclusively in that zone from 

BWM requirements. In support of this 

position, the commenters noted that a 

ballast water bill passed by the U.S. 

House of Representatives in 2008 

determined that the Great Lakes were an 

‘‘enclosed aquatic ecosystem’’ and 

exempted vessels that confine their 

operations to those waters from 

installing BWMS. 

Ten commenters suggested that 

vessels operating exclusively in the Gulf 

of Mexico be exempt from BWM 

requirements. In support of this 

position, the commenters noted a high 

level of connectedness between 

different areas of the Gulf of Mexico and 

the fact that the National Oceanic and 

Atmospheric Administration considers 

the Gulf of Mexico to be a single ‘‘Large 

Marine Ecosystem’’ based on ecological 

criteria. 

The Coast Guard acknowledges the 

issues raised in these comments and 

will continue to work with the scientific 

community and regulatory agencies to 

investigate the bases for establishing 

more ecologically meaningful 

geographic zones for regulating ballast 

water operations. 

Other Applicability 

Two commenters urged the Coast 

Guard to consider the use of land-based 

or vessel/barge-based reception/ 

treatment facilities. The Coast Guard 

agrees that use of shore-based or bargebased treatment might become a valid 

option for some vessels and has 

provided for this in the final rule. We 

have done so by revising the language 

in the regulations to make it clear that 

the BWDS only applies to those vessels 

falling within the rule’s applicability 

thresholds (vessels that also discharge 

ballast water into waters of the United 

States). Those vessels discharging to 

land-based or vessel/barge-based 

reception/treatment facilities would not 

fall within this defined group, and 

therefore would not be required to 

install a BWMS that meets the BWDS. 

Any reception/treatment facilities used 

under this option would be subject to 

applicable state and local laws, as well 

as NPDES permitting if the treated water 

is discharged to waters of U.S. 

Four commenters requested that the 

Coast Guard exempt any vessel that 

does not discharge ballast water in 

waters of the United States. Three 

additional commenters argued that 

vessels not discharging ballast water 

into the waters of the United States 

should not be subject to the requirement 

to install BWMS. 

It was never the intention of the Coast 

Guard to require vessels to install a 

BWMS if they do not discharge ballast 

water into waters of the United States. 

We have clarified in this final rule that 

vessels not discharging ballast water 

into the waters of the United States are 

not required to install a BWMS. 

However, unless exempted, vessels are 

still required to report their BWM 

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17262 Federal Register / Vol. 77, No. 57 / Friday, March 23, 2012 / Rules and Regulations 

practices on their Ballast Water 

Reporting Form. 

One commenter suggested that 

applicability be based on a vessel’s 

ballast water capacity. The Coast Guard 

notes that applicability of the rule is 

based, in part, on vessel ballast water 

capacity. While the discharge standard 

does not vary by vessel type, the dates 

at which vessels must meet the ballast 

water discharge standard if using a 

BWMS are based on vessel ballast water 

capacity. 

As we move forward with expanding 

the applicability of this rule, however, 

we will continue to consider multiple 

factors, including ballast water capacity. 

One commenter recommended 

exempting offshore floating platforms 

from the regulations, as these facilities 

rarely move. The Coast Guard does not 

believe that a categorical exemption is 

warranted. Under this final rule, an 

offshore floating platform would be 

exempted as long as it conducts ballast 

operations exclusively within a single 

COTP Zone. Additionally, we believe 

there are operational practices (e.g., 

offload to a reception vessel) that will 

allow an offshore floating platform to 

comply with the BWM regulations 

without having to install a BWMS. 

One commenter suggested exempting 

reduced operating status (ROS) vessels 

that spend the majority of their time in 

layup or reduced crew status and are 

activated for short times (Maritime 

Administration Ready Reserve or 

Military Sealift Command vessels). The 

Coast Guard believes that if a vessel is 

not operating, it should not be 

discharging ballast water and there 

would be no requirements to meet when 

in ROS. In addition, in the event an ROS 

vessel meets the definition of a vessel of 

the Armed Forces under Section 312 of 

the Federal Water Pollution Control Act 

(33 U.S.C. 1322), it would be exempt 

from this final rule by section 

151.2015(a)(191). 

One commenter asked that 

exemptions and exceptions in the rule 

be consistent with the IMO BWM 

Convention. The Coast Guard believes 

that the commenter was referring to 

exemptions to the requirement to meet 

a BWDS that nation states could grant 

under the IMO BWM Convention once 

it enters into force. It is the Coast 

Guard’s position that all vessels should 

take all practicable measures to ensure 

NIS are not discharged into the waters 

of the United States from vessels 

through ballast water; however, we note 

that we have included exemptions and 

exceptions in this final rule that are 

consistent with both our statutory 

mandate under NANPCA, as amended 

by NISA, and international law, 

including but not limited to the IMO 

BWM Convention (which has not yet 

entered into force). We will continue to 

develop our regulations and work with 

other countries to protect our 

environment. 

2. BWDS 

General Concern 

Eighteen commenters submitted 

general concerns on the BWDS. Seven 

commenters stated their general 

opposition to the NPRM and three 

commenters stated their general 

support. Two commenters believed 

there was insufficient scientific and 

technical support in the record for the 

proposed regulation. 

Four commenters stated that the 

BWDS and implementation schedule 

must be protective of the Great Lakes 

and one commenter expressed this 

concern for all waters of the United 

States. One commenter requested that 

the final regulations reflect reasonable 

and balanced programs that harmonize 

the commercial importance and 

environmental value of the Great Lakes. 

The Coast Guard acknowledges these 

general concerns. Many of these 

concerns are echoed in more specific 

comments that we received, and those 

are summarized and addressed 

previously in this preamble and in the 

text that follows. 

Support Concept 

Twelve commenters supported the 

concept of a numeric, concentrationbased BWDS, and three commenters 

said that such a BWDS will create the 

necessary market conditions to 

encourage investment in and 

development of technologies capable of 

achieving the objective of this rule. The 

Coast Guard agrees with these 

comments, and believes that setting a 

numeric, concentration-based BWDS in 

this final rule is the best approach to 

reducing the threat of the introduction 

and spread of NIS into the waters of the 

United States. 

Stringency of Standard 

One commenter supported the idea of 

a U.S. BWDS that at least meets the IMO 

BWM Convention Regulation D–2 

discharge standard (IMO discharge 

standard) and any subsequent standard 

improvements. Another commenter 

stated that although they support the 

development of a BWDS like the phasetwo standard, they also believe that 

starting with the achievable, 

measurable, and protective phase-one 

standard poses a much lower risk to the 

environment than starting with a stricter 

standard that is unachievable and 

immeasurable. 

Six commenters supported 

establishing a discharge standard that is 

more stringent than the proposed phaseone standard, two of which also said the 

implementation schedule would not be 

protective as quickly as needed. Six 

commenters supported the proposed 

phase-two standard that is equivalent to 

the most stringent State standards, 

currently 1,000 times more stringent 

than the IMO discharge standard. One 

commenter said that the standard 

should be alternative 5 of the Draft 

Programmatic Environmental Impact 

Statement (DPEIS), which is essentially 

sterilization of ballast water. 

One commenter stated that they did 

not support the adoption of a standard 

more stringent than the IMO discharge 

standard due to the impracticability of 

performing the necessary measurements 

to approve BWMS and test compliance. 

One commenter stated that no 

technology developers with whom they 

have discussed treatment efficacy have 

been willing to provide assurances that 

their BWMS could reliably meet the 

phase-two standard, which is 1,000 

times more stringent than the IMO 

discharge standard. This commenter 

further disagreed with the California 

State Lands Commission’s (CSLC) 

conclusion that several BWMS have 

demonstrated the potential to comply 

with California’s performance standards 

for the discharge of ballast water, and 

called for the Federal Government to 

perform its own analysis when 

conducting the practicability review 

prior to full implementation of the 

phase-two standard. 

One commenter noted that the Great 

Lakes are a drinking water source and 

an irreplaceable freshwater natural 

resource. This commenter stressed the 

importance of implementing strong 

environmental regulations to protect 

such waters from the introduction of 

new NIS as well as from the 

establishment of new populations of 

NIS that currently exist within these 

waters. 

Two commenters noted what they 

termed a lack of sufficient scientific and 

technical support in the record for the 

proposed regulation. 

As we have noted in this preamble, 

this final rule is implementing the 

phase-one standard, which is equivalent 

to the IMO discharge standard, and 

deferring action on the phase-two 

standard until we can complete more 

analyses and research into practicability 

(see V.A. Summary of Changes from the 

NPRM). 

The EPA SAB study (EPA SAB 2010), 

issued after publication of the NPRM for 

this rulemaking, provides support for 

our conclusion that technology to 

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achieve the IMO discharge standard 

represents the limit of current 

practicability. The SAB found that 

‘‘* * * five of 34 categories of assessed 

BWMS achieved reductions in organism 

concentrations sufficient to comply with 

the first standard proposed by the USCG 

(i.e., the ‘Phase 1’ standard).’’ Further, 

the SAB also concluded that ‘‘ * * * 

current test methods and detection 

limits preclude a complete statistical 

assessment of whether a BWMS meets 

any standard more stringent than Phase 

1’’ (U.S. EPA SAB, 2011). We agree with 

the commenter who stated that 

implementing a less stringent, attainable 

standard that provides at least as much 

protection as BWE as soon as possible 

provides more protection than 

establishing a stricter standard and 

continually postponing it or deferring 

enforcement until it is achievable. We 

note the findings and recommendations 

of the National Research Council’s 

(NRC) Committee on Assessing Numeric 

Limits for Living Organisms, which 

concluded that ‘‘The current state of 

science does not allow a quantitative 

evaluation of the relative merits of 

various discharge standards in terms of 

invasion probability.’’ The Committee 

further recommended that ‘‘(a)s a logical 

first step, a benchmark discharge 

standard should be established that 

clearly reduces concentrations of coastal 

organisms below current levels resulting 

from ballast water exchange (such as the 

IMO D–2 standard).’’ 

While the Coast Guard agrees that it 

is necessary to have a protective 

standard in place as quickly as possible, 

we have delayed the initial 

implementation dates for newly 

constructed vessels to allow for the 

implementation of the U.S. typeapproval process. The Coast Guard does 

not believe that it is possible to 

implement this process any faster, and 

that such a deferral is inevitable. 

The Coast Guard disagrees with the 

commenters who stated there was an 

insufficient record for the NPRM as a 

whole. While we have already 

acknowledged that more analysis on the 

impacts of the phase-two standard 

should be completed, both the economic 

and environmental analyses that 

accompanied the NPRM contained 

information that, when combined with 

our discussion of the proposed rule in 

the NPRM preamble, provided 

reasonable justification for the NPRM. 

Zero Discharge 

Fifteen commenters advocated for the 

establishment of a zero-discharge 

standard, and said there should be no 

living organisms allowed in ships’ 

ballast water. Four commenters said that 

NISA requires the Coast Guard to 

establish such a zero-discharge 

standard. 

Conversely, three commenters 

opposed setting a zero-discharge 

standard, which they claimed would be 

operationally and practically 

unachievable. One commenter stated 

that the current knowledge of invasion 

biology seems to be insufficient to 

define no-risk discharge criteria. 

Two commenters stated that the longterm goal should be zero discharge of 

live organisms. 

The Coast Guard disagrees that NISA 

requires a zero-discharge standard. 

NISA requires the Coast Guard to 

develop regulations that prevent the 

introduction and spread of NIS to the 

maximum extent practicable, and we 

have no data that support setting a zerodischarge standard as being practicable. 

However, the Coast Guard is committed 

to implementing the most stringent 

BWDS that can practicably be achieved. 

As evidence of this, the Coast Guard has 

already indicated in this preamble that 

in a subsequent publication, after 

additional analysis and research, we 

intend to finalize the proposed phasetwo standard or any standard higher 

than phase-one, as well as the recurring 

practicability reviews that were 

included in the NPRM, with the goal of 

determining and achieving the most 

protective BWDS practicable (see V.A. 

Summary of Changes From the NPRM). 

Phase-One Standard 

Fourteen commenters stated their 

support for the phase-one standard that 

is equivalent to the IMO discharge 

standard. One commenter requested that 

the phase-one standard become the 

permanent standard for the United 

States. 

The Coast Guard agrees with the 

commenters who supported the phaseone standard, as we believe this 

standard is practicable, achievable, and 

provides a level of protection that is at 

least as effective as BWE. However, the 

Coast Guard also believes that future 

work, such as that suggested by the EPA 

SAB (EPA SAB 2011) and the NRC 

Committee (NAS 2011), may result in a 

better understanding of the need for 

more stringent standards and the 

development of improved technologies 

for treating ballast water on vessels, and 

will continue to work toward improving 

protective requirements in accordance 

with the directions and authorities in 

NANPCA 90. 

Thirteen commenters opposed the 

phase-one standard on the grounds that 

it was not sufficiently protective. One 

commenter proposed that the phase-one 

standard be set at 10 times more 

stringent than the IMO discharge 

standard, 5 commenters proposed that 

the phase-one standard be set at 100 

times more stringent than the IMO 

discharge standard, and 4 commenters 

proposed that the phase-one standard be 

set at 1,000 times more stringent than 

the IMO discharge standard, which 

would be the equivalent of the proposed 

phase-two standard. 

One commenter suggested dropping 

the phase-one standard and 

immediately undertaking a 

practicability review of the phase-two 

standard, which the commenter 

believed would result in an indefinite 

deferral of the phase-two standard as 

non-practicable. One commenter 

opposed the phase-one standard 

proposed in the NPRM without giving 

specific reasons. 

The Coast Guard has found, based on 

the best scientific information available 

to the Coast Guard (including the 

previously referenced EPA SAB study 

on technologies and systems to 

minimize the impacts of invasive 

species in vessel ballast water discharge 

(EPA SAB 2011)), that there are 

currently no BWMS that have 

demonstrated the capability to meet a 

standard more stringent than the phaseone standard. Additionally, there are no 

available, standardized testing protocols 

that can be used to demonstrate that a 

BWMS can meet a standard 100 or 1,000 

times more stringent than the phase-one 

standard. 

Implementing both the phase-one and 

a more stringent but unachievable 

standard in a single rulemaking would 

result in foregoing the near-term 

protection this rulemaking provides. 

The Coast Guard believes ensuring this 

near-term protection now is in line with 

our statutory mandate from NANPCA, 

as amended by NISA. As we explained 

in this preamble, we are not abandoning 

the phase-two standard (see V.A. 

Summary of Changes from the NPRM). 

We are committed to implementing a 

standard that provides the most 

protection that can practicably be 

achieved. 

One commenter opposed the phaseone standard on the grounds that it 

would be difficult to assess and 

therefore enforce. The Coast Guard 

disagrees. The EPA has already issued 

its ETV Protocol, which is incorporated 

by reference into this final rule and will 

be used to assess a BWMS’ success in 

meeting the BWDS. The Coast Guard’s 

type-approval process provides a strong 

means of verifying whether a BWMS 

can likely achieve the BWDS when 

installed and operating. Finally, Coast 

Guard port-state control officers will 

provide the final enforcement check to 

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ensure that a BWMS is operating as it 

should to meet the BWDS. 

One commenter requested a 

modification to the phase-one standard 

to account for organisms less than 10 

micrometers in size. The Coast Guard 

disagrees that this is necessary for the 

phase-one standard, as the IMO 

discharge standard did not include this 

size category. We may consider 

additional size categories for the phasetwo standard. 

Two commenters requested that the 

phase-one standard be aligned with the 

IMO discharge standard and other 

provisions of the IMO BWM 

Convention. The Coast Guard believes 

that we have made the phase-one 

standard as consistent as possible with 

the IMO discharge standard. We have 

made a slight adjustment in our 

implementation schedule to allow for 

practical realities involved in 

implementing a U.S. type-approval 

program, but we have also included a 

provision to allow for BWMS that have 

been approved by foreign 

administrations under the IMO BWM 

Convention to be accepted on an interim 

basis (see discussion in V.A. Summary 

of Changes from the NPRM). 

Phase-Two Standard 

Thirteen commenters supported the 

phase-two standard as proposed in the 

NPRM. One commenter stated that 

vessels would benefit by having to 

install a BWMS only once at a 

potentially more protective standard. 

One commented that adopting the 

phase-two standard would encourage 

manufacturers to modify existing 

BWMS components and develop new 

technologies that could meet multiple 

stringency standards. 

Conversely, 47 commenters opposed 

the phase-two standard as being 

counterproductive on the grounds that 

there are no accepted test protocols or 

BWMS that have been proven to meet 

any limits more stringent than phaseone. Two commenters opposed the 

phase-two standard because BWMS 

manufacturers have focused their 

research, development, and certification 

efforts on the IMO discharge standard, 

and may not have the resources to start 

over. 

One commenter requested that a size 

category for organisms less than 10 

micrometers be added to the phase-two 

standard. Two commenters requested 

removing the phase-two standard for 

viruses due to the impracticability of 

treating for viruses and the difficulty of 

testing virus viability. One commenter 

stated there are no technologies, 

scientific methods, or protocols to 

differentiate between active versus 

inactive virus-like particles, which 

would make it impossible to measure 

the efficacy of BWMS in achieving the 

proposed phase-two standard for 

viruses. 

Two commenters said that the phasetwo standard should only allow for use 

of less stringent standards under 

temporary special exemption cases (e.g., 

vessel types or discharge characteristics) 

as determined by a technology review. 

One commenter suggested an interim 

measure like Michigan’s BWM 

regulation, which identified specific 

treatment processes. The commenter 

believed that such an approach could be 

implemented across the Great Lakes 

more quickly than the proposed 

standards. 

Three commenters stated that the 

phase-two standard should be delayed 

until instrumentation and methods are 

available to measure the capability of 

BWMS to meet the standard. One 

commenter stated that the phase-two 

standard is unnecessarily stringent for 

vessels that operate in the Great Lakes. 

One commenter stated that the phasetwo standard should not have a defined 

value before the results of the 

practicability review are known. 

One commenter opposed the phasetwo standard for vessels that operate 

solely on the Great Lakes, arguing that 

the large volumes of treated water being 

discharged would essentially distill the 

Great Lakes of essential organisms 

necessary for aquatic health. 

One commenter stated that one 

BWMS could meet multiple stringency 

standards by adjustment of its 

operational parameters, although this 

may depend on the treatment 

methodology of a particular system. 

One commenter recommended that 

phase-two technologies should be based 

on conversions of the existing phase-one 

platforms. 

As we have discussed in this 

preamble, this final rule only contains 

implementation requirements for the 

phase-one standard (see V.A. Summary 

of Changes from the NPRM). We are 

taking all of the comments we received 

on the phase-two standard into 

consideration as we begin the process of 

completing economic and 

environmental analyses for the phasetwo standard, and will continue to 

consider these comments as we draft a 

notice or other rulemaking document 

addressing the phase-two standard. 

Grandfather Period 

Seven commenters opposed any 

grandfather period. Two of these 

commenters argued that vessels that 

install a phase-one system should not be 

exempt from the phase-two standard. 

One of these commenters requested that 

best available technology be required at 

all times, which would eliminate the 

use of a grandfather period. 

One commenter stated that the 

grandfather period should be decreased 

from 5 to 3 years, whereas two 

commenters argued that 5 years was an 

appropriate grandfather period. 

Fifteen commenters stated that 5 years 

was not long enough for a grandfather 

period. Twelve commenters stated that 

an installed BWMS should be 

grandfathered for the useful life of the 

vessel, and 10 commenters stated that 

BWMS should be grandfathered for the 

effective life of the system. Fourteen 

commenters stated that an installed 

BWMS should be grandfathered for the 

life of either the vessel or BWMS, 

whichever ends first. 

One commenter stated that the 

grandfather period should be increased 

from 5 years to 10 years or the lifetime 

of the vessel, one commenter stated that 

it should be increased to 15 years, two 

commenters stated that it should be 

increased to 15 years or the life of the 

vessel, and one commenter stated that 

vessels should be given a specific date 

by which to upgrade once a phase-two 

standard is established. 

As discussed in this preamble in V.A. 

Summary of Changes from the NPRM, 

the Coast Guard is not including the 

phase-two standard in this final rule. 

Because the final rule only includes the 

phase-one standard, we have omitted 

the grandfather provision that we 

proposed in the NPRM. We expect to 

reconsider the grandfather provision 

when we address the proposed phasetwo standard or any standard higher 

than phase-one in a notice or other 

rulemaking document. We will keep 

these comments in mind as we develop 

that proposal. 

Practicability Review 

Thirty nine commenters supported a 

practicability review that is sufficiently 

robust and comprehensive to determine 

whether a BWDS more stringent than 

the phase-one standard is achievable. 

One of these commenters said that the 

review should be limited to the testing 

and certification requirements of the 

IMO BWM convention and guidelines. 

Six commenters recommended that the 

practicability review ensure that any 

phase-two standard is effective, 

measurable, technologically feasible, 

commercially available, safe, and costeffective for use with the characteristics 

of the vessel. 

One commenter said the regulation 

should contain an express statement 

that the Coast Guard will not make 

upward revisions of the treatment 

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standard unless it is economically 

reasonable to do so, and that we should 

include criteria for that determination. 

Another commenter said that if and 

when a BWMS can achieve the phasetwo standard of 1,000 times more 

stringent than the IMO discharge 

standard, no further practicability 

reviews should be conducted with 

regard to achieving even higher 

standards. 

Ten commenters said that a 

practicability review should be 

conducted for the phase-one standard as 

well. Twenty three commenters said 

that the reviews must verify there are 

BWMS that are suited to the volumes, 

flow rates, and engine room 

specifications of Great Lakes vessels 

before imposing the phase-one standard 

on these vessels. 

Six commenters agreed with the 

proposed 3-year cycle for practicability 

reviews, seven recommended that the 

reviews be conducted on a continuous 

basis, three recommended that the 

reviews be conducted every year, one 

suggested a 3- to 5-year cycle, and three 

recommended a 5-year cycle. 

Six commenters wanted a firm 

deadline for practicability reviews. Six 

others stated that the timing and scope 

should be accelerated from 2010 to 2012 

to inform both the phase-two standard 

and the 2013 renewal of the EPA VGP. 

Conversely, 19 commenters opposed 

any practicability review that could 

indefinitely delay implementation of the 

final standard, calling it a ‘‘loophole.’’ 

Eight of these commenters requested an 

electronic docket and public comment 

period before any final determinations 

based on practicability reviews are 

made. One commenter stated that 

moving the practicability review would 

not allow time for vessels with a 2014 

compliance date to implement 

technology that meets the phase-two 

standard. Two commenters said there is 

no evidence presented in the NPRM or 

DPEIS to justify claims that the phasetwo standard is not currently 

achievable, and therefore the 

practicability review is not necessary. 

Three commenters requested a 

definition for ‘‘practicability’’ and for 

the inclusion of specific content and 

format of the review. One commenter 

said the rule should place an upper 

limit on how long the implementation 

date can be extended at any given time. 

One commenter stated that there should 

be a practicability review for vessels 

based on the type of vessel and the 

geographic route(s) it serves, (i.e., oceangoing service, inland waters, Great 

Lakes, near coastal, etc.). 

As discussed in this preamble in V.A. 

Summary of Changes from the NPRM, 

because we have removed the phase-two 

standard from this final rule, we have 

also removed the recurring 

practicability reviews that were 

included in the NPRM. We expect that 

regular assessments, per NISA’s 

‘‘[p]eriodic review and revision’’ 

provisions, codified at 16 U.S.C. 

4711(e), will be part of any future 

rulemaking process. This will address 

the scenario in which a finalized phasetwo standard either cannot be 

implemented according to the 

established timelines, or can be 

implemented more quickly than the 

established timeline. 

There is one practicability review 

provision included in this final rule that 

requires the Coast Guard to complete 

and publically publish the results of a 

practicability review no later than 

January 1, 2016. This review will draw 

a significant component of its 

information from the type-approval 

application packages that the Coast 

Guard expects to evaluate between this 

final rule’s publication date and the 

initial implementation date. Further, the 

findings and recommendations of the 

EPA SAB study (EPA SAB 2011) will 

usefully inform the development of the 

practicability review. The Coast Guard 

will look at a variety of factors, 

including but not limited to the efficacy 

and environmental safety of available 

technology, and economic factors. 

While we have listed a number of these 

factors in the rule, there is a provision 

allowing for consideration of additional 

factors. We included this provision 

because of the possibility that the Coast 

Guard may discover additional factors 

that would be relevant to a decision on 

whether or not it is practicable to 

increase the stringency of the BWDS. 

These changes address some of the 

comments summarized previously. We 

will continue to keep comments related 

to the recurring practicability reviews in 

mind as we develop a notice or other 

rulemaking document implementing the 

phase-two standard. While we have not 

included a practicability review prior to 

the implementation of the phase-one 

standard, we have included a provision 

to allow vessel owners and operators to 

request an extension of their compliance 

date if they cannot practicably comply 

with the compliance date otherwise 

applicable to their vessel. Summary 

information concerning all extension 

decisions, including the name of the 

vessel and vessel owner, the term of the 

extension, and the basis for the 

extension will be promptly posted on 

the U.S. Coast Guard Maritime 

Information Exchange Web site 

(CGMIX), currently located at [http:// 

cgmix.uscg.mil/Default.aspx]. 

Implementation Schedule 

One commenter was opposed to 

extending the phase-two deadline 

unless a future public comment period 

establishes that such an extension is 

necessary to allow for practicable 

implementation of the phase-two 

standard. Four commenters agreed with 

the proposed schedule for 

implementation of both the phase-one 

and the phase-two standards. 

Eighty one commenters requested that 

the implementation schedule be 

changed in some way. Eleven 

commenters stated that a BWDS should 

take effect immediately, and one 

commenter said it should be 

implemented in 1 year. One commenter 

said the phase-two standard should take 

effect immediately, while another said 

that 3 to 5 years is plenty of time. Three 

commenters stated that the phase-two 

standard should take effect by 2012 and 

one said it should take effect by 2016. 

Three commenters opposed reliance on 

drydocking schedules in favor of hard 

deadlines for compliance, unless 

justified by vessel-specific engineering 

constraints or lack of availability. 

One commenter stated that existing 

vessels should be required to schedule 

their first drydocking by 2012, and to 

comply with the phase-one standard by 

2014 unless the practicability review 

deems that deadline unattainable. One 

commenter suggested installation at the 

first dry dock after 2014. Two others 

suggested that a more appropriate 

timeline for all new and existing vessels 

would be 2012 or 2014, respectively. 

Thirty three commenters said that the 

phase-one standard should be 

implemented by 2012 and the phasetwo standard by 2016. Another 

commenter agreed with this schedule 

but with a more stringent phase-one 

standard. One commenter supported a 

phase-one standard 100 times more 

stringent than the Coast Guard’s 

proposal by 2012 and a phase-two 

standard 1,000 times more stringent 

than phase one by 2016. 

Two commenters considered the 

schedule for implementation of the 

proposed regulations to be too 

protracted, and called for 

implementation of the phase-two 

standard at an earlier date than 

proposed. These organizations did not 

support allowing shipowners so much 

time between the implementation date 

and their first scheduled drydock. 

Conversely, 26 commenters requested 

that the implementation schedule be 

lengthened or allow more flexibility for 

vessel types or specific geographic 

areas. Thirteen commenters said that the 

dates should be delayed until 

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compatible BWMS are commercially 

available for their vessels and to 

accommodate standard drydocking 

cycles of twice in 5 years. One 

commenter said that vessels traveling to 

specific areas such as the Great Lakes 

could comply with the 2014 date, but 

did not think this was a realistic option 

to apply to vessels in all waters of the 

United States. 

One commenter stated that the 

proposed schedule does not allow 

enough time for vendors to develop 

BWMS capable of meeting the phasetwo standard, particularly since 

methods and facilities capable of testing 

to the phase-two standard will need to 

be available in order to develop such 

systems. 

One commenter stated that vessels 

confined to the Great Lakes will not 

have sufficient shipyard availability to 

install equipment to meet the BWDS on 

the proposed schedule. Four 

commenters stated that some vessels 

operating in the Great Lakes have very 

short voyages (on the order of hours). If 

BWMS available for such vessels are 

limited to chemical systems with 

required minimum treatment times 

longer than the voyages, then significant 

delays will occur in the transportation 

chain. Two industry associations 

commented that the proposed schedule 

was not feasible due to a lack of 

available BWMS and a shortage of 

shipyard capacity for installation. 

The Coast Guard considered these 

comments. First, to accommodate the 

implementation of the final rule in 

relation to delays encountered in the 

rulemaking process, the Coast Guard has 

revised the implementation schedule for 

the phase-one standard at 33 CFR 

151.1512(b) and 151.2035(b) to provide 

new vessels the 2 years for 

implementation as presented in the 

2009 proposed rule. Addressing 

concerns with the schedule more 

generally, while we agree with those 

commenters who would like to see a 

requirement that BWMS be installed on 

vessels as soon as possible, it is 

important to consider several factors 

that impact the timeline during which 

approved BWMS can be expected to be 

installed. These include the time 

required for the United States to 

implement a BWMS approval process, 

for manufacturers to establish 

production capacity, and for vessel 

owners to acquire and install BWMS 

within their vessels’ normal operational 

and maintenance schedules. As a result, 

there will likely not be an adequate 

number of approved BWMS to allow for 

acceleration of the implementation 

schedule in the 2009 proposed rule. 

Phase-two and its implementation 

schedule are not addressed in this final 

rule. As discussed in the ‘‘Summary of 

Changes from the NPRM’’ section above, 

the Coast Guard will develop additional 

analyses regarding the potential costs, 

benefits, and environmental impacts of 

the proposed phase-two standard or any 

standard higher than phase-one and 

intends to address the issue in 

subsequent rulemaking document. 

Language Clarification/Technical 

Change 

One commenter requested that the 

proposed BWDS include language 

necessary for differentiation between 

living and nonliving organisms. Another 

said that the standard should allow for 

the presence of nonliving organisms 

since some treatment technologies act to 

kill living organisms without 

necessarily removing them from the 

ballast water. 

The Coast Guard acknowledges that 

the proposed BWDS is slightly different 

in this respect from the IMO discharge 

standard, which uses the term ‘‘viable’’ 

instead of ‘‘living.’’ It is important to 

note that, while the text of the IMO 

BWM Convention refers to ‘‘viable’’ 

organisms, the G8 guidelines define 

‘‘viable’’ as ‘‘living.’’ Therefore, the 

Coast Guard has decided that this issue 

is best addressed in the BWMS approval 

process, and will not alter the standard 

as suggested by these commenters. We 

note that the standard and approval 

process do allow for the presence of 

nonliving organisms. Additionally, we 

corrected a technical error present in the 

NPRM, which mistakenly omitted the 

term ‘‘living’’ from the proposed 33 CFR 

151.1511(a). This final rule corrects that 

omission. 

One commenter requested an addition 

to the BWM requirements in 33 CFR 

151.2025(a)(1) that would read ‘‘(i) 

Unless 151.2040(b) allows otherwise, 

the BWMS must be used prior to any 

discharge of ballast water to waters of 

the U.S. (ii) All treatment must be 

conducted in accordance with the 

BWMS manufacturer’s instructions and 

standard of performance approved by 

the Coast Guard.’’ 

The Coast Guard disagrees that this 

addition is necessary. Vessel owners/ 

operators must comply with the BWDS 

for all ballast water discharged 

following treatment with a BWMS, and 

follow the manufacturer’s Operation, 

Maintenance, and Safety Manual to 

maintain their systems in proper 

working order. 

One commenter asked that a 

definition be provided for ‘‘regular’’ and 

‘‘regularly,’’ as those terms are used in 

33 CFR 151.2050, which requires 

vessels owners or operators to clean 

their ballast tanks regularly to remove 

sediments and to remove fouling 

organisms from hull, piping, and tanks 

on a regular basis. The Coast Guard 

disagrees, and believes that there should 

be some flexibility to schedule these 

activities according to a vessel’s specific 

circumstances. 

One commenter believes that portions 

of 33 CFR 151.2050 (additional 

requirements) are intended to be 

discretionary rather than mandatory, 

and should be separate categories. The 

Coast Guard disagrees. The Coast Guard 

included the term ‘‘minimize or avoid’’ 

in 33 CFR 151.2050(b) to ensure that 

vessel owners and operators always 

consider these additional requirements, 

while allowing some flexibility 

according to a vessel’s specific 

circumstances. 

One commenter suggested adding a 

definition for ‘‘test report’’ at 46 CFR 

162.060–3, as the term is used in 

multiple places. The Coast Guard 

disagrees, as the Test Report is 

described in 46 CFR 162.060–34. 

One commenter suggested revising 

the proposed definition for ‘‘hazardous 

location’’ found in 46 CFR 162.060–3. 

The Coast Guard agrees and revised the 

definition. 

One commenter suggested requiring 

contact information, in addition to 

manufacturer’s name, in 46 CFR 

162.060–10(a)(1). This commenter also 

suggested that the phrase ‘‘Name and 

type of BWMS’’ in 46 CFR 162.060– 

10(a)(3) be revised to also require the 

mode of action or other information. 

The Coast Guard partially agrees; we 

have added a requirement for point of 

contact information for the 

manufacturer to 46 CFR 162.060–10. 

However, we have not made the 

requested change to 46 CFR 162.060– 

10(a)(3), as we believe this is already 

reflected in the existing text. 

One commenter asked that the phrase 

‘‘novel processes’’ in 46 CFR 162.060– 

10(e) be defined. The Coast Guard 

disagrees, because it does not wish to 

preclude any innovative approaches in 

BWMS. 

One commenter asked whether the IL 

or manufacturer is required to submit 

the Test Report to the Coast Guard 

Marine Safety Center (MSC) as part of 

the approval process. The Coast Guard 

approval process places responsibility 

on the manufacturer to submit all 

necessary materials to the MSC, 

however, it is acceptable if the IL 

submits the report directly to the MSC. 

One commenter was unsure what 

types of approvals are required under 46 

CFR 162.060–14(a)(7), such as those 

from U.S. agencies, foreign 

administrations, classification societies, 

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and other organizations. The Coast 

Guard’s response is that 46 CFR 

162.060–14(a)(7) pertains to approval of 

BWMS using active substances, and that 

manufacturers are responsible for 

obtaining all required approvals 

external to the Coast Guard’s approval 

process. We anticipate issuing guidance 

documents to aid manufacturers in 

complying with the approval process. 

One commenter noted what appeared 

to be conflicting information as to 

exactly which vessels this rule would 

apply to and whether all vessels would 

be required to install BWMS. The Coast 

Guard responds that these are separate 

but related questions. First, 33 CFR 

151.1502 in the existing regulations and 

33 CFR 151.2010 (Applicability) of this 

final rule describe which vessels will be 

required to comply with 33 CFR part 

151 subparts C and D, or subsections of 

them. This is a broad description, as 

many vessels not required to install a 

BWMS will need to comply with other 

requirements in 33 CFR part 151 subpart 

D, such as recordkeeping requirements. 

Several groups of vessels are exempted 

from BWM requirements under 

§ 151.2015. 

Secondly, 33 CFR 151.2025 (BWM 

requirements) of the final rule identifies 

which vessels must install a BWMS that 

complies with the BWDS, or manage 

their ballast water in another one of the 

methods listed in that section. 

One commenter requested 

clarification of the requirement 

‘‘Records any bypass of the BWMS’’ at 

46 CFR 162.060–20(b)(5). The 

commenter noted that not all BWMS 

will be able to do this, as some bypasses 

may be achievable using systems or 

components that are outside of the 

BWMS. The Coast Guard agrees and has 

removed this provision. 

Management Requirements 

Two commenters suggested that the 

practicability of on-shore or vessel/ 

barge-based ballast water treatment be 

explored. The Coast Guard encourages 

the development of alternative 

treatment methods that would allow 

some vessels to manage their ballast 

water without having to install a 

BWMS. The phase-one standard in this 

final rule will only apply to vessels that 

discharge ballast water into waters of 

the United States. Vessel owner/ 

operators discharging ballast water to a 

facility onshore or to another vessel 

must ensure that all vessel piping and 

supporting infrastructure up to the last 

manifold or valve immediately before 

the dock manifold connection of the 

receiving facility or similar 

appurtenance on a reception vessel 

prevents untreated ballast water from 

being discharged into waters of the U.S. 

Once Ballast water is pumped to an 

on shore treatment facility or a 

treatment vessel it would not be subject 

to 33 CFR part 151 subpart C or D. 

However, under the CWA any resulting 

discharges from these on-shore 

treatment facilities or treatment vessels 

are subject to the National Pollutant 

Discharge Elimination System (NPDES) 

program. Companies that intend to 

provide these services will be 

responsible for complying with these 

and other local, state, and Federal laws 

and regulations. 

One commenter suggested requiring 

BWMS in addition to, rather than 

instead of, existing BWE requirements 

for ocean going vessels entering the 

Great Lakes-St. Lawrence Seaway 

system. The Coast Guard disagrees. 

Requiring both BWE and BWMS for 

oceangoing vessels entering the Great 

Lakes was not proposed in the NPRM 

and therefore beyond the scope of this 

rulemaking. 

One commenter stated that the 

allowance of BWE under the phase-one 

standard is inconsistent with the goal of 

minimizing NIS introductions and 

should be eliminated as an option. The 

Coast Guard agrees that BWE should be 

eliminated as an option as soon as 

possible. The primary purpose of 

NANPCA, as amended by NISA, is to 

‘‘prevent the unintentional introduction 

and dispersal of nonindigenous species 

into waters of the United States through 

ballast water management and other 

requirements.’’ 16 U.S.C. 4701(b). 

Permitting BWE to remain as a 

permissible management technique in 

light of other, more protective methods, 

would frustrate this clearly articulated 

statutory purpose and lead to an absurd 

result. See Griffin v. Oceanic 

Contractors, Inc., 458 U.S. 564, 575, 102 

S.Ct. 3245 (1982) (statutory 

interpretations ‘‘which would produce 

absurd results are to be avoided if 

alternative interpretations consistent 

with the legislative purpose are 

available.’’) The Coast Guard is thus 

phasing out BWE as a BWM method in 

favor of more protective methods to best 

prevent the introduction and spread of 

NIS into waters of the U.S. consistent 

with this statutory purpose. 

We also believe that existing vessels 

should be given a reasonable period of 

time to come into compliance with the 

phase-one standard, and that BWE 

should continue as a viable BWM 

alternative for a vessel until the phaseone standard applies to that vessel. 

However, we note that once a vessel is 

required to comply with the phase-one 

standard, BWE will no longer be an 

acceptable routine management method. 

One commenter noted the U.S. 

Administration’s goal of expanding 

coastwise or short-sea shipping, and 

requested that BWE be added as a 

management option for these vessels. 

The Coast Guard notes that its existing 

regulations do not require coastwise 

vessels to conduct BWE unless their 

voyage takes them more than 200 

nautical miles from any shore. For the 

final rule, we have revised 33 CFR 

151.2015 to exempt certain vessels from 

the BWM requirements and 33 CFR 

151.2025 to provide additional BWM 

options besides installing BWMS. These 

changes are discussed above under the 

heading ‘‘Applicability.’’ 

One commenter suggested retaining 

BWE for all vessels when practicable, 

requiring a combination of best 

available technology and BWE to 

improve BWMS performance, and 

requiring BWE as a minimal treatment 

in case the BWMS fails. Another 

suggested the addition of rules requiring 

BWE 50 nautical miles outside the 

continental baseline for vessels 

conducting coastal voyages, 

implementation of a BWE verification 

system, and allowance of BWE within 

200 nautical miles when a safety 

exemption would otherwise allow unexchanged water to be discharged at a 

State port. The Coast Guard disagrees, 

and believes that phasing out BWE in 

favor of the BWM requirements in this 

final rule will be at least as effective as 

BWE to prevent the introduction of NIS 

into the waters of the United States. The 

Coast Guard notes that under 33 CFR 

151.2040(b), the COTP may allow the 

vessel to conduct BWE as a management 

option if the BWMS fails to operate or 

the vessel’s BWM method is 

unexpectedly unavailable. 

Preamble Text 

One commenter disagreed with the 

statement in the NPRM that ‘‘The 

effectiveness of BWE is highly variable, 

largely depending on the specific vessel 

and voyage’’ (74 FR 44663). The 

commenter added that the Great Lakes 

Seaway Ballast Water Working Group’s 

strict enforcement of BWE requirements 

in the St. Lawrence Seaway is the main 

reason that there have been no reports 

of the establishment of invasive species 

on the Great Lakes since 2006. 

The Coast Guard acknowledges the binational success in achieving high rates 

of regulatory compliance with existing 

BWE requirements. However, we do not 

have evidence that this successful 

enforcement necessarily proves the 

effectiveness of BWE, as there are also 

other regulations and requirements 

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being enforced for vessels entering the 

St. Lawrence Seaway. 

Enforcement 

Seventeen submitters commented on 

how the Coast Guard intends to enforce 

the BWDS. 

Three commenters said there should 

be significant financial penalties to 

provide incentives for industry to meet 

implementation deadlines. The Coast 

Guard notes that the existing civil and 

criminal penalties for 33 CFR part 151 

subparts C and D are established by 

statute and were not changed in the 

NPRM. They may now be found at 33 

CFR 151.2080 of the final rule. After 

publication of the NPRM, in a separate 

action, the Coast Guard made an 

adjustment to the civil penalty tables 

found at 33 CFR 27.3. (75 FR 36273, 

36278 (June 25, 2010)). 

Five commenters stated that the 

numeric discharge standard would 

impose significant problems for 

compliance enforcement, particularly 

when results need to be legally 

acceptable, because sufficient 

techniques or equipment are not 

currently available to test ballast water 

on the spot. The Coast Guard disagrees, 

and believes that setting a practicable, 

numeric BWDS such as this final rule’s 

BWDS, combined with type approval of 

BWMS, will facilitate compliance 

enforcement. 

Another commenter said that a phasetwo standard 1,000 times more stringent 

than the phase-one standard will be 

virtually impossible to enforce, and will 

significantly increase enforcement costs, 

and possibly increase downtime for 

inspected vessels. The Coast Guard 

agrees that implementation of the phasetwo standard at this time could be 

impracticable for several reasons, 

including enforcement, as suggested by 

the commenter. 

Two commenters requested that a 

rigorous enforcement, inspection, and 

monitoring program be developed to 

determine compliance, similar to that 

currently being performed by the binational Great Lakes Seaway Ballast 

Water Working Group for all vessels 

entering the St. Lawrence Seaway. 

Three commenters requested routine or 

random testing of the contents of a 

vessel’s ballast tanks and ballast water 

discharge. One commenter said this 

testing would be especially important 

for oceangoing vessels that would 

discharge treated ballast water into 

freshwater. Two commenters suggested 

testing for total residual oxidants in 

ballast water as a way to determine the 

completion of chemical treatment, and 

installing onboard sensors in vessels’ 

ballast tanks to measure chemical levels. 

Four commenters asked about port 

state control requirements. One 

commenter requested that a limit of 

once in any calendar year must be 

imposed on the number of times that a 

vessel can be tested to determine 

whether its BWMS is working properly, 

and that onboard sensor data or the 

captain’s signed and sworn certification 

transmitted to the port state authority 

should be sufficient. Another 

commenter said that vessel-based 

BWMS would not enable the port state 

authority to monitor ballast water. Two 

commenters stated that proper and 

effective sampling and test protocols, as 

well as required facilities and 

proficiency, still need to be established. 

One commenter requested specific 

information indicating how the BWDS 

will be enforced after implementation. 

The Coast Guard believes that the 

approval process for BWMS, found in 

46 CFR part 162.060 of this final rule, 

will provide a strong basis from which 

enforcement actions can proceed based 

on review of the records required to be 

kept on the vessel. These reviews will 

occur during port and flag state control 

exams. We acknowledge that 

compliance exam procedures for BWMS 

will be an important component of 

enforcement, and such procedures are 

under development. As discussed in the 

Summary of Changes section above, we 

have added a provision requiring 

sampling ports in order to facilitate 

enforcement of the BWDS. 

Reporting and Recordkeeping 

One commenter requested that the 

Ballast Water Reporting Form and 

reporting and recordkeeping 

requirements be revised to 

accommodate all of the proposed BWM 

methods in advance of the phase-one 

standard taking effect. The Coast Guard 

agrees, and will propose revisions to the 

Ballast Water Reporting Form and 

instructions either through a separate 

rulemaking project or in conjunction 

with the next scheduled renewal of the 

collection by OMB. 

One commenter said the NBIC should 

be given regular dates for reporting 

information that they obtain from 

submitted reports. The Coast Guard 

notes that the NBIC already provides 

database information to the public 

through its Web site. As more vessels 

use electronic reporting, the NBIC is 

reducing delays in updating that Web 

site. 

3. BWMS 

General 

Two commenters addressed the safety 

exception in 33 CFR 151.2045. The first 

commenter recommended that ‘‘vessel 

design limitations’’ should not be 

considered an ‘‘extraordinary 

condition’’ under which a master or 

person in charge of a vessel would be 

exempt from the requirement to use a 

BWM practice, including BWE, under 

certain circumstances. The second 

commenter supported the inclusion of 

the exception and interpreted it as 

allowing the discharge of ballast water 

that fails to meet the BWDS under 

emergency circumstances. 

The Coast Guard believes that they 

may have misunderstood this provision. 

Under NISA, masters or persons in 

charge of vessels are not required to 

conduct BWE if the practice would be 

unsafe due to weather or vessel design. 

16 U.S.C. 4701(k)(1). We have included 

this provision in the regulation, and it 

is an allowable exception to BWE only 

as long as a vessel is allowed to use 

BWE. Additionally, we have removed 

proposed 33 CFR 151.2045 Safety 

exceptions, as we determined that it was 

largely repetitive to what was proposed 

in 33 CFR 151.2040 Discharge of ballast 

water in extraordinary circumstances. 

We moved the one non-repetitive 

provision to § 151.2040. As a result, 

§ 151.2040 now includes the provision 

noting that nothing in the regulations 

relieves the master, owner, agent, or 

person in charge of the vessel from any 

responsibility, including the safety and 

stability of the vessel and the safety of 

the crew and passengers. 

Once a vessel is required to meet the 

BWDS, the general safety provision in 

§ 151.2040 no longer applies. If the 

master or person in charge of the vessel 

determines that operation of the BWMS 

would endanger the vessel for some 

reason, the master or person in charge 

must inform the COTP, prior to the 

vessel’s arrival, that BWM has not been 

conducted due to safety reasons. The 

COTP will evaluate the situation and 

direct the vessel accordingly. 

One commenter considered the 

BWMS design and construction 

requirements to be onerous and likely to 

result in systems being overly 

complicated and expensive. The 

commenter called for the Coast Guard to 

approve the use of very simple 

approaches, such as manually pouring 

additives into tanks. The Coast Guard 

disagrees, and believes that all BWMS 

must be carefully designed, constructed, 

and approved to protect the vessel, the 

crew and passengers, and the 

environment. With respect to the 

example, treatment of ballast water 

using chemicals designed to kill 

organisms has the potential to adversely 

affect the safety of the vessel, the crew 

and passengers, and the environment if 

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the chemicals and the manner of their 

use are not carefully evaluated in 

advance and controlled and managed 

during use of the system. 

Seven commenters stated that there 

were serious constraints on the 

feasibility of installing BWMS that 

require electrical service on tank barges 

and tank ships. Several commenters 

cited Coast Guard regulations for 

electrical equipment as an impediment 

to such installation (46 CFR 111.105– 

31(1)). Likewise, six vessel owners 

asserted that safety and regulatory 

requirements prohibit the installation 

on tank barges of BWMS that use 

electricity. 

The Coast Guard agrees that electrical 

requirements included in 46 CFR 

subpart 162.060 may make installation 

of BWMS more complicated on certain 

vessels. However, if these requirements 

make it impossible for a vessel owner to 

safely install a BWMS, they should 

qualify for an extension of the 

compliance date, per 33 CFR 151.1513 

or 151.2036. An extension would 

provide additional time to determine 

how BWMS can be safely installed. An 

extension would postpone installation 

costs for affected vessels. Data is 

unavailable on the number of vessels 

that would require extensions. We have 

not estimated the quantitative impacts 

of extensions. 

One commenter proposed that the 

Coast Guard should require best 

available technology and BWE as an 

interim measure if compliant BWMS are 

not available by the implementation 

dates. The Coast Guard disagrees that 

best available technology and BWE 

together should be considered the de 

facto acceptable method of compliance. 

The Coast Guard considers establishing 

a practicable and protective BWDS to be 

the best approach for preventing the 

introduction of NIS by the wide array of 

vessels that must discharge ballast water 

for safe operation. 

The Coast Guard believes that BWMS 

meeting the phase-one BWDS will 

generally be available in time for vessel 

owners and operators to comply with 

the implementation schedule in this 

final rule. For those cases where this is 

not so, we have provided a provision in 

the regulation that allows a master, 

owner, operator, agent, or person in 

charge of a vessel to apply for an 

extension of the compliance date. 

One commenter asserted that BWE is 

sufficiently protective in preventing 

introductions of invasive species. This 

commenter also suggested that BWE 

should be an acceptable method of 

BWM if a vessel can demonstrate 

through sampling and analysis that 

BWE can meet the BWDS. Two 

commenters asserted that BWE is 

sufficiently protective in preventing 

invasive species introductions to the 

Great Lakes. These commenters further 

suggested that BWE should be an 

acceptable method of BWM for vessels 

entering the Great Lakes. 

The Coast Guard disagrees that BWE 

is sufficiently protective against 

introductions of invasive species. 

Vessels are not always able to conduct 

BWE. While BWE has undoubtedly 

reduced the risk of introductions 

compared to no BWM at all, the 

inherent variability in the efficacy of 

BWE among vessels and even within 

vessels argues for the consistent 

application of more effective BWM 

practices. Additionally, as vessels on 

coastwise voyages are not required to 

conduct BWE under Coast Guard 

regulations, a BWMS is also necessary 

to ensure the prevention of the spread, 

and not just the introduction, of NIS. 

One commenter questioned whether 

BWMS will effectively remove all 

contaminants in ballast water and 

asserted that onboard treatment will not 

be a viable option until that is the case. 

The commenter suggested that, as an 

alternative, vessels could use multiple 

systems to address all contaminants. 

The Coast Guard appreciates the 

commenter’s concerns, but disagrees 

that a BWMS required under this rule 

will have to remove all potential 

contaminants in ballast water. 

NANPCA, as amended by NISA, 

requires the Coast Guard to ensure, to 

the maximum extent practicable, 

introductions of NIS are not discharged 

into the waters of the United States from 

vessels, and does not pertain to vessel 

discharges outside of that threat. The 

statute also requires that certain 

methods of BWM used instead of BWE 

must be environmentally sound. By 

requiring such systems to meet 

applicable EPA requirements related to 

treatment chemicals and their 

disinfection by-products prior to 

discharge, the Coast Guard will help 

ensure that treatment of ballast water 

does not result in adverse 

environmental consequences. The issue 

of non-organism contaminants in ballast 

water is also addressed under the EPA 

VGP. By requiring BWMS to meet all 

applicable EPA requirements prior to 

type approval, the Coast Guard will help 

ensure that treatment of ballast water 

does not create adverse consequences. 

One commenter questioned whether 

onboard treatment is the best approach, 

given that IMO approval of BWMS is 

proceeding slowly. The Coast Guard 

disagrees that the pace of BWMS type 

approval under the IMO BWM 

Convention is proceeding slowly. In 

fact, we note that foreign type-approved 

systems are available. 

One commenter questioned whether 

onboard systems were the best approach 

for preventing the discharge of 

organisms and noted that, unless a 

vessel is fitted with a backup system, 

the failure of the onboard treatment 

system could result in the discharge of 

untreated ballast. The Coast Guard notes 

that the rule has been revised to clarify 

that vessel owners and operators have a 

range of options for BWM, including use 

of BWMS, retention onboard, discharge 

to a shoreside treatment facility, or use 

of a U.S. PWS meeting Safe Drinking 

Water Act standards. We also note that 

the regulation requires BWMS to signal 

an alert if there is a failure and for vessel 

owners to report failures of the BWMS 

to the COTP at their place of 

destination. In such a situation, the 

COTP may require the vessel to perform 

alternative BWM practices before 

allowing the discharge of the ballast 

water. 

Active Substances or Chemicals 

One commenter asserted that many 

currently available BWMS use 

chemicals, and that these BWMS may 

result in contamination of ballasted fish 

holds. The commenter further stated 

that the proposed regulation must 

include exemptions for this 

circumstance. The Coast Guard agrees 

that chemical contamination of 

ballasted fish holds may be a problem 

with the use of a chemically-based 

BWMS. However, the Coast Guard is 

aware of several systems that do not use 

chemicals, and believes that owners and 

operators of fishing vessels will have 

sufficient options for meeting the BWDS 

(e.g., ultraviolet/filtration). For those 

fishing vessels that cannot install a 

BWMS onboard, we have provided a 

provision in the regulation that allows 

a master, owner, operator, agent, or 

person in charge of a vessel to apply for 

an extension of the compliance date if 

they can document that, despite all 

efforts to meet the BWDS requirements, 

compliance by that deadline is not 

possible. 

Three commenters called for 

clarification as to how the regulations 

proposed in the NPRM would prevent 

the discharge of harmful active 

substances resulting from the use of 

BWMS. The Coast Guard agrees that the 

use of chemicals such as biocides to 

treat ballast water creates the potential 

for unwanted discharges of such 

chemicals. All systems using chemicals 

must be registered by EPA under the 

Federal Insecticide, Fungicide, and 

Rodenticide Act (FIFRA), as applicable, 

prior to consideration by the Coast 

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17270 Federal Register / Vol. 77, No. 57 / Friday, March 23, 2012 / Rules and Regulations 

Guard for type approval. Discharges 

from vessels with systems using nonpesticide chemicals (or pesticides that 

are generated solely by the use of a 

device onboard the same vessel as the 

ballast water to be treated) will be 

covered under the EPA VGP, which 

contains requirements to meet discharge 

limits established by EPA for residuals 

and by-products of chemicals used in 

ballast water treatment. All chemicals 

used in BWMS requiring FIFRA 

registration will be registered with EPA 

prior to applying for Coast Guard typeapproval of the BWMS. One commenter 

encouraged the Coast Guard to allow 

treatment of ballast water with biocides 

to address specific species on specific 

routes within the Great Lakes as an 

alternative method of compliance. The 

Coast Guard appreciates this 

commenter’s input, but disagrees with 

the proposed approach. The 

identification, with appropriate 

specificity, of the location and identity 

of every infestation within the Great 

Lakes is not feasible, nor is the 

identification of the appropriate biocide 

for each specific species. The Coast 

Guard has determined that the most 

protective approach is to require the 

uniform treatment of ballast water to 

reduce concentrations of all organisms 

prior to discharge. 

Alternatives to BWMS 

Thirteen commenters disagreed with 

the requirement for all applicable 

vessels to install BWMS, and called for 

the Coast Guard to allow vessels the 

flexibility to use other approaches, such 

as discharging to receiving vessels or to 

shoreside facilities. The Coast Guard 

agrees. As discussed previously 

regarding the comments dealing with 

applicability, we have revised our 

regulation to clarify that only vessels 

discharging ballast water into waters of 

the United States are required to comply 

with the BWDS requirements at 33 CFR 

151.1510 and 151.2025 of this final rule. 

However, the dependence of the vessel 

on the availability of appropriate 

reception facilities must be identified in 

the vessel’s BWM plan, along with the 

alternative management practices that 

will be used if and when discharge to 

a reception facility is not possible. 

Further, the lack of availability of 

adequate reception facilities is not an 

acceptable reason for discharge of 

ballast water that does not meet the 

BWDS into the waters of the United 

States, and such a discharge will 

constitute a violation of this regulation. 

One commenter stated that vessels 

should be required to discharge to a 

shore-side treatment facility prior to 

entering the Great Lakes. The Coast 

Guard disagrees that vessels should be 

required to discharge to a shore-side 

facility. The Coast Guard believes it is 

important that vessels have the 

flexibility to select the BWM practice 

that makes the most sense for their 

specific circumstances. If vessel owners 

and operators want to have the option 

of discharging to shore and sufficient 

market exists for such an option, then it 

is likely that such facilities will be 

created. 

One commenter stated that it may not 

be technically or economically feasible 

for a vessel owner to retrofit existing 

vessels with an approved BWMS, and 

recommended that the Coast Guard 

allow other BWM options under such 

circumstances. As described in 33 CFR 

151.2025 and 151.2026, ballast water 

management practices other than use of 

a Coast Guard-approved BWMS will be 

allowed. 

Additionally, vessels will have the 

options of discharging to a shoreside 

treatment facility or receiving vessel, if 

available, or retaining ballast water 

onboard. The Coast Guard will evaluate 

claims that BWMS and other allowed 

BWM practices are not available for 

specific vessels and potentially extend 

the compliance date for those vessels. 

Foreign Type Approvals 

Eleven commenters discussed the 

Coast Guard’s proposed provision for 

the acceptance of foreign type approvals 

of BWMS. Four of the commenters 

supported the Coast Guard’s proposal 

that such acceptance should be granted 

only when the foreign procedures are 

equivalent to those of the Coast Guard. 

Conversely, six of the commenters 

stated that the Coast Guard should 

accept foreign type-approvals without 

verifying equivalency of testing 

protocols. 

The Coast Guard’s approval process is 

intended to provide a level of assurance 

that a BWMS is likely to work 

consistently, effectively (i.e., meet the 

BWDS), and safely under shipboard 

conditions. Testing conducted with 

insufficient rigor or under substantially 

less challenging conditions will not 

provide that assurance. The Coast Guard 

retains the prerogative to verify the 

equivalency of foreign type-approval 

procedures before accepting such 

approvals. 

One commenter stated that since the 

phase-one BWDS is equivalent to the 

IMO discharge standard, the Coast 

Guard must consider the protocol in the 

G8 guidelines to be sufficiently strict. 

The Coast Guard disagrees, and will 

assess each foreign administration’s 

type-approval procedures, including test 

protocols and quality assurance 

practices, to determine whether the 

performance assessment conducted by 

the foreign administration is equivalent 

to that of the Coast Guard and complies 

with applicable U.S. domestic laws. We 

will evaluate, in accordance with the 

standards in the revised 46 CFR 

162.060, the data and supporting 

information in approval applications 

submitted by manufacturers whose 

BWMS have received foreign type 

approval. We will not grant U.S. type 

approval to BWMS approved by foreign 

administrations based on approval 

procedures that are substantively less 

rigorous than the U.S. approval testing 

without additional testing as necessary 

and appropriate for the specific 

circumstance. 

The Coast Guard recognizes some 

time will elapse between the 

publication of this final rule and the 

availability of U.S. approved BWMS. 

The Coast Guard believes that ballast 

water discharged into waters of the 

United States should undergo some type 

of treatment designed to reduce the risk 

of ballast water spreading NIS at the 

earliest possible date, particularly for 

those vessels currently unable to 

conduct BWE, as we believe this will 

provide greater reduction in the risk of 

NIS being introduced or spread via 

ballast water. Therefore, we have added 

a provision to the final rule to allow for 

a temporary acceptance of a foreign 

administration’s approval if it can be 

shown that the foreign-approved BWMS 

is at least as effective as BWE. This 

temporary acceptance will be granted 

for 5 years from the date when the 

vessel on which the BWMS is installed 

is required to comply with the BWDS. 

Two commenters requested that the 

rule include more details about the 

procedures the Coast Guard will follow 

to make determinations regarding the 

acceptance of foreign type approvals. 

The Coast Guard agrees and has made 

changes to 46 CFR 162.060–12, which 

are discussed in the Summary of 

Changes section above. The Coast Guard 

expects to examine each foreign 

administration’s type-approval report, 

which should include the testing 

protocols used and the testing results, 

and then make a determination as to 

whether the procedures and criteria 

used were essentially equivalent in rigor 

and challenge to those of the Coast 

Guard. Additionally, in order to grant 

U.S. type approval or the temporary 

acceptance (as an AMS), the Coast 

Guard must comply with NEPA and 

other applicable environmental laws. 

One of the commenters suggested that 

the Coast Guard use an advisory panel 

of independent scientists and agency 

representatives to conduct the 

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equivalency determinations for foreign 

administration’s type-approval 

programs. The Coast Guard will make 

use of appropriate expertise in 

reviewing proposals for acceptance of 

foreign type approvals, including, when 

necessary, consultation with other 

agencies and outside experts. 

One commenter referenced the text in 

the NPRM preamble that states: ‘‘Under 

today’s proposal, foreign vessels 

equipped with and operating a BWMS 

that has been approved by a foreign 

administration would be allowed to use 

the BWMS for discharging ballast water 

into U.S. waters if the Coast Guard 

determines that the foreign 

administration’s approval process is 

equivalent to the Coast Guard’s approval 

process, the BWMS otherwise meets the 

requirements of this proposed rule, and 

the resulting discharge into waters of 

the U.S. meets the applicable (i.e., 

phase-one or phase-two) proposed 

discharge standard.’’ The commenter 

suggested that this text be changed to 

replace ‘‘foreign vessel’’ with ‘‘vessel,’’ 

so that U.S.-flagged ships which 

currently have installed BWMS that 

have been type approved by a foreign 

administration under the specified 

conditions would be acceptable. 

The Coast Guard has clarified the 

procedures in 46 CFR 162.060–12 which 

allow manufacturers of foreign typeapproved BWMS to submit data 

developed during the foreign typeapproval testing to support the 

submission of an application pursuant 

to 46 CFR 162.060–14. The Coast Guard 

will evaluate the application and 

determine if U.S. type approval will be 

granted. If U.S. type approval is granted, 

the BWMS can be installed and used on 

U.S. and foreign flagged vessels. 

Availability of BWMS 

One commenter stated that it is 

unlikely that any systems have 

documented test results to demonstrate 

compliance with a standard that is 100 

or 1,000 times stricter than phase-one. 

The Coast Guard agrees that no 

sufficiently credible documentation 

exists of BWMS able to meet 

concentrations 100 or 1,000 times more 

stringent than the proposed phase-one 

standard. The Coast Guard notes that 

the EPA SAB came to the same 

conclusion in its recent report (EPA 

SAB 2011). 

Two commenters stated that BWMS 

that can meet the Coast Guard’s 

proposed BWDS are available now. The 

Coast Guard agrees that technologies 

capable of meeting the phase-one BWDS 

will be available for installation on 

applicable vessels on the required 

implementation schedule. We do not, 

however, agree that there is a currently 

available BWMS that has been shown to 

meet the phase-two BWDS. 

In response to the Coast Guard’s 

question, ‘‘Are there technology systems 

that can be scalable or modified to meet 

multiple stringency standards after 

being installed?’’ one commenter stated 

that technology is available, pending 

adjustments, for ‘‘Lakers,’’ vessels 

operating solely on the Great Lakes. The 

Coast Guard notes that our question 

specifically asked for quantitative 

information on technologies, necessary 

modifications, costs, and sources of 

such information. The comment did not 

include quantitative information. 

Therefore, we are unable to validate this 

claim. 

One State government agency stated 

that the availability of technology that 

meets the phase-two standard is 

demonstrated by the findings of the 

CSLC report on BWM technologies. This 

report concluded that at least seven 

commercially available BWMS had 

demonstrated the capability to comply 

with California’s performance 

standards. 

The Coast Guard disagrees. In the 

CSLC 2010 report on the availability of 

technology to meet California 

requirements, the State Lands 

Commission acknowledged the 

limitations of testing data and clarified 

that the Commission’s analysis 

determines whether or not systems have 

demonstrated the potential to comply 

with California’s standards. (CSLC Sept 

2010). The ‘‘potential to comply’’ 

determination was based on whether the 

reported efficacy data for the systems 

examined indicated that at least one test 

(averaged across replicates) met 

California’s standards for every testable 

organism size class during either landbased or shipboard testing. 

It is important to recognize that 

California’s phase 2 discharge standard 

for organisms greater than 50 

micrometers (one millionth of a meter, 

mm) is ‘‘no detectable living organisms,’’ 

and is not defined by a specific 

volumetric concentration (i.e., 

California’s phase 2 discharge standard 

is not equivalent to a concentration 

1,000 times smaller than the IMO 

standard, or to any other standard 

expressed as a concentration). In its 

report, the Commission concluded 

‘‘Thus, California’s standard for this 

organism size class is not directly 

comparable to the IMO or standards 

proposed by other entities evaluated by 

these reports.’’ 

Because of the difficulties of testing 

treatment technologies to meet 

standards more stringent than the 

IMO’s, the Commission convened its 

Ballast Water Treatment Technology 

Technical Advisory Panel, which 

recommended that the best option for 

California was to maintain the ‘‘no 

detectable organisms’’ standard for 

larger organisms, and develop and adopt 

compliance verification protocols. At 

this point, it is not known what those 

protocols, or their detection limits, will 

be, but is instructive that the EPA SAB 

concluded that ‘‘* * * current test 

methods and detection limits preclude a 

complete statistical assessment of 

whether a BWMS meets any standard 

more stringent than Phase 1.’’ 

One commenter questioned whether a 

BWMS will be available to allow the 

industry to meet the BWM requirements 

on the schedule proposed in the NPRM. 

As discussed elsewhere in this 

preamble, the Coast Guard has made 

changes to the applicability in order to 

address this very question. We have also 

delayed the initial compliance date for 

new vessels by 2 years to provide time 

for the U.S. type-approval process to be 

implemented. It is our belief that there 

will be suitable BWMS on the market 

for those vessels required to comply 

with the BWDS in this final rule. The 

companies bringing BWMS to the 

market include many with international 

supply and service networks. Further, 

existing information indicates that not 

all BWMS will need to be installed in 

drydock or even while the vessel is out 

of service. However, to address the 

situation where, through no fault of 

their own, a vessel owner cannot install 

a BWMS on time, we have also included 

a provision allowing the Coast Guard to 

extend that particular vessel’s 

compliance date. 

One commenter stated that treatment 

technology is not available for barges 

with large ballast water capacity. The 

Coast Guard neither agrees nor disagrees 

with this comment. We recognize that 

some vessels will present challenges 

due to the specific nature of their design 

and operations. We have made 

adjustments to this final rule’s 

applicability and implementation 

timeline to allow the Coast Guard to 

deal with these challenges either on a 

one-on-one basis (as with a request for 

an extension of compliance) or up front 

en masse (as with the removal of certain 

vessels from the BWDS applicability). 

One commenter stated that the design 

of some vessels is not appropriate for 

current approaches to BWM and 

proposed that technical feasibility be 

taken into account. The commenter 

specifically referenced the lack of 

electrical power and personnel available 

to operate BWMS onboard unmanned, 

unpowered barges. The Coast Guard 

agrees that technical feasibility is an 

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important consideration, and has 

included it as one of many factors that 

must be considered during the Coast 

Guard’s practicability review. Two 

commenters asserted that the 

installation of BWMS on their vessels 

would not be economically feasible, but 

did not provide any additional data. 

Given the issues raised by these and 

other commenters, the Coast Guard has 

revised the applicability of the BWDS 

rule. The Coast Guard is publishing this 

final rule to apply the phase-one BWDS 

only to the following vessels 

discharging ballast water into water of 

the United States: vessels entering 

waters of the United States from outside 

the EEZ, and those seagoing vessels that 

operate in more than one COTP Zone 

and are greater than 1,600 GRT (3,000 

GT (ITC)). The Coast Guard has 

determined that additional analysis is 

needed before expanding the 

applicability in this final rule. 

Additionally, the Coast Guard has 

decided the BWM requirements will not 

include vessels that operate solely in 

inland waters. The Coast Guard fully 

intends to expand the BWDS rule to all 

vessels, as noted in the final rule 

preamble section V.A. Summary of 

Changes from the NPRM, but has 

determined that additional analysis is 

necessary to support this expansion. We 

also intend to conduct additional 

research as necessary. 

Eight commenters stated that they 

were unaware of any available BWMS 

designed for vessels operating 

exclusively in freshwater. The Coast 

Guard disagrees, as there are several 

BWMS currently on the market or 

advancing through approval procedures 

in other countries that are based on 

treatment processes that function 

independently of salinity, such as 

filtration and ultraviolet radiation (UV). 

Many BWMS using active substances, 

particularly electrolytic chlorination, 

can work effectively in freshwater if 

provided an appropriate source of ions 

such as seawater or brine held in a tank. 

While it still remains for these systems 

to be approved by the Coast Guard, the 

fact that they are being approved by 

other countries in accordance with the 

standards set forth in the IMO BWM 

Convention for use in meeting a 

standard equivalent to the phase-one 

standard indicates there are likely to be 

BWMS that will be effective when used 

on vessels that operate exclusively in 

freshwater. 

One commenter stated that BWMS are 

available that are capable of treating 

small volumes and flow rates and would 

fit in vessels with low space availability. 

The Coast Guard notes this information. 

Funding Issues 

One commenter stated that it is 

incumbent on the Coast Guard and 

Canadian agencies to cooperatively 

assist companies to design and market 

BWMS that may need to be unique to 

the Great Lakes. The Coast Guard 

disagrees that the government of the 

United States, either alone or in 

cooperation with Canada, must assist 

companies to design and market BWMS 

beyond encouraging such actions 

through the establishment a BWDS. 

Two commenters asserted that 

provision of adequate funding is 

necessary to facilitate the development 

of technology for treating ballast water 

and for implementation of the proposed 

regulation. The availability of funding 

for either development of technology or 

implementation of this final rule is 

outside the scope of this rule. 

Four commenters stated that this 

regulation should include provisions for 

BWMS testing and application fees to 

support testing and review processes 

within Federal agencies and ILs. One 

submitter commented that there is a 

need for increased research and 

development funding for testing and 

development of BWM technologies. The 

Coast Guard disagrees that the rule 

should specify fees for testing and 

application review. Costs of testing will 

be determined by the ILs. 

Specific BWMS Requirements 

One commenter stated that the 

requirement for the BWMS to retain 

records of operation for 24 months is 

excessive and will result in significant 

additional costs. The commenter 

proposed instead that the period of 

record retention in the BWMS be 

reduced to 6 months, and that data older 

than that be acceptable if retained on 

disks. The Coast Guard agrees this 

would be more efficient and has 

clarified requirements for record 

retention to allow for electronic data 

collection in lieu of a hard copy by 

revising 46 CFR 162.060–20(b)(5) and 

(b)(6), and added 33 CFR 151.2070(d). 

One commenter stated the Coast 

Guard should not automatically 

decertify a formerly approved BWMS 

when the manufacturer goes out of 

business or ceases to support a typeapproved system. The Coast Guard 

agrees with the commenter that the 

issue of concern should be whether or 

not the BWMS is capable of being 

operated properly and effectively. The 

provision for de-certification is included 

to allow the Coast Guard to suspend 

approval of BWMS that cannot be 

properly maintained as a consequence 

of business decisions by the 

manufacturer. 

One commenter stated the use of an 

operational, type-approved BWMS 

should be sufficient for compliance, and 

that vessel masters should not be held 

to discharge standards that they cannot 

themselves measure or understand 

without specialized scientific or 

engineering training. The Coast Guard 

disagrees with the commenter. The 

intent of NANPCA, as amended by 

NISA, is to prevent the introduction and 

spread of unwanted organisms in 

vessels’ ballast water. For this reason, 

the Coast Guard has proposed a BWDS 

that we believe is practicable to 

implement. Type approval alone cannot 

ensure that vessel discharges meet the 

BWDS; it can only increase the 

probability that systems used to meet 

the BWDS will be effective. It is the 

vessel owner or operator’s responsibility 

to meet the discharge requirement. 

One commenter stated that failure to 

use an approved BWMS as required 

should be a violation, even when 

another allowable practice is used. The 

Coast Guard believes that the 

regulations as drafted in the final rule 

clarify as to whether a violation has in 

fact occurred would depend on the 

particular circumstances. Vessels with 

an inoperable BWMS will be required to 

inform the appropriate COTP prior to 

arrival. The COTP will evaluate the 

circumstances and inform the vessel of 

required alternatives, as well any 

finding of a violation that would result 

in an enforcement action. 

Independent Laboratories (IL) 

Three commenters questioned 

whether sufficient numbers of ILs will 

exist that can perform the required 

testing of BWMS for type approval. The 

Coast Guard acknowledges the key role 

that ILs will play in the type-approval 

process. The Coast Guard is aware of 

several organizations in the United 

States and abroad that have stated their 

intention to serve as ILs and that have 

taken steps to create the infrastructure 

and organizational capacities to perform 

the functions. The Coast Guard will not 

know definitively whether enough 

organizations capable of conducting the 

test procedures exist until such time as 

organizations apply for designation by 

the Coast Guard and are determined to 

meet the requirements for ILs testing 

BWMS. The Coast Guard will move 

quickly to announce its availability to 

accept applications for designation. 

Five commenters discussed the 

importance of having a sufficient 

availability of qualified ILs for effective 

and timely implementation of the 

proposed rule. The Coast Guard agrees 

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that, as with other installed vessel 

equipment, ILs will play a critical role 

in ensuring that marketed technologies 

are highly likely to meet the regulatory 

requirements for which they are 

intended. It is our belief that the 

publication of this final rule, as well as 

our stated intent to follow up with a 

subsequent rule implementing a more 

stringent standard after additional 

analysis and research, will provide 

incentive for the creation of additional 

ILs. 

Two commenters stated that the Coast 

Guard should audit ILs to ensure the 

integrity of the testing process. The 

Coast Guard agrees; audits are a 

standard component of the Coast 

Guard’s oversight of ILs (46 CFR subpart 

159.010). 

Four commenters discussed ILs in 

reference to existing test facilities. Three 

advised that existing facilities that 

conduct tests of BWMS, particularly the 

Great Ships Initiative (GSI), should be 

utilized as ILs. One commenter advised 

the Coast Guard to work closely with 

established programs and other 

appropriate experts to develop testing 

procedures. The Coast Guard is aware of 

most, if not all, existing test facilities in 

the United States and internationally, 

including GSI, and would welcome IL 

applications from any qualified 

organization once the procedures for 

certification of ILs are implemented. 

The Coast Guard has worked with most 

of the existing test facilities in the 

United States in the development of 

standard test procedures for BWMS 

under the EPA ETV Protocol and will 

continue to do so. 

One commenter stated that the 

timeframe for designation of ILs should 

be specified. The Coast Guard disagrees 

that specification of the time frame for 

designation of ILs should be part of the 

regulation. There are too many 

unknowns prior to receiving the 

applications to be able to set a deadline. 

Additionally, there should be no limit 

on a facility’s opportunity to apply to 

become an IL after the initial round of 

applications and approvals are 

completed. 

Three commenters requested, 

respectively, that academic institutions, 

classification societies, and agencies of 

foreign governments be eligible for 

consideration as ILs. The Coast Guard 

agrees with the commenters. We 

consider the existing specifications for 

ILs in 46 CFR 162.060–3 and 162.060– 

40 to be inclusive of the types of 

organizations identified by these 

commenters. 

Three commenters called for the Coast 

Guard to approve a specific list of 

entities that could be accepted as ILs. 

The Coast Guard disagrees with the 

recommendation. Listing specific 

entities in the regulation could serve as 

a disincentive to other entities who 

could also meet all of the requirements 

to become an IL. The Coast Guard will 

make publicly available a list of 

accepted ILs on the Coast Guard 

Maritime Information Exchange 

(CGMIX) Web site, http:// 

cgmix.uscg.mil/. 

Three commenters recommended that 

the Coast Guard include provisions for 

adequate funding for its Federal 

activities and the activities of the ILs in 

this regulation. Two of the commenters 

specifically suggested setting fees for 

application review and testing. The 

Coast Guard clarifies that type-approval 

applicants must handle all IL testing 

costs through individual contracts for 

services with ILs. The Coast Guard 

currently does not have express 

authority to charge fees for 

implementing these BWM requirements. 

Two commenters urged the Coast 

Guard to presumptively accept certified 

IL test results without conducting 

substantial additional reviews, in the 

interest of streamlining the typeapproval process and avoiding 

unnecessary delays in making approved 

systems available. The Coast Guard 

agrees that delays should be minimized. 

The point of designation and regular 

oversight of ILs via audits is to avoid the 

need for time-consuming reviews of 

individual test reports. However, the 

Coast Guard must assess each 

individual test report for the BWMS 

being tested, and make an independent 

determination of the BWMS. This 

obligation cannot be delegated to the 

ILs. Additionally, the Coast Guard’s 

type-approval determination is a 

Federal agency action that must be 

analyzed under NEPA and other 

applicable U.S. environmental laws. 

Two commenters specifically 

supported the Coast Guard’s proposed 

use of ILs to conduct testing associated 

with type-approval determinations. 

One commenter recommended that a 

manufacturer or vendor should be 

allowed to use multiple ILs as necessary 

and efficient during the different phases 

of approval testing. The Coast Guard 

agrees that a BWMS vendor may use the 

services of more than one entity to most 

effectively conduct the required tests, 

and there are provisions in this final 

rule that allow for this. However, in the 

interest of organizational and 

administrative efficiency, the Coast 

Guard requires that one IL coordinates 

and oversees all testing and reporting 

for each type-approval application. 

Changes to Specific Sections 

Two commenters stated that all uses 

of ‘‘should’’ in 33 CFR 151.2050 need to 

be changed to ‘‘must’’ to reflect the fact 

that the previously voluntary provisions 

are now requirements. The Coast Guard 

agrees. We have revised 33 CFR 

151.2050 accordingly. 

One commenter requested that the 

definition of ‘‘major conversion’’ be 

consistent with the definition of the 

term in the IMO BWM Convention. The 

Coast Guard disagrees; we did not 

propose any changes to the ‘‘major 

conversion’’ definition in the NPRM, 

and do not believe any change is 

necessary at this time. 

One commenter recommended 

changing the text in 33 CFR 151.2005(b) 

to revise the definition of ‘‘empty/refill 

exchange’’ to replace the word ‘‘should’’ 

with the word ‘‘must.’’ The Coast Guard 

agrees that the wording needs to reflect 

the mandatory nature of the 

requirement, thus we have revised the 

text accordingly. 

One commenter called for the Coast 

Guard to revise the text of 33 CFR 

151.2040(a) to read that a vessel retains 

‘‘all of its ballast water,’’ instead of ‘‘its 

ballast water,’’ as currently written. The 

Coast Guard disagrees that the change is 

necessary, as the existing text is already 

inclusive. 

Two commenters requested that the 

text in 33 CFR 151.2040 and 151.2045 

clearly state that the responsibility to 

meet the legal requirements of the 

regulation still applies to vessels that 

claim extraordinary circumstances or 

invoke the safety exemption. The 

commenters presumed that while the 

infraction would exist, fines or penalties 

would be mitigated to reflect the 

circumstances. The Coast Guard agrees 

with the commenters’ presumption. 

Vessels unable to meet the BWM 

requirements will be required to inform 

the COTP prior to arrival. The COTP 

will evaluate the circumstances and 

direct the vessel accordingly, which 

may include the imposition of fines or 

penalties. 

One commenter recommended that 

the introductory paragraphs of the 

appendix to subpart D of 33 CFR part 

151—Ballast Water Reporting Form and 

Instructions for Ballast Water Reporting 

Form introductory paragraph be revised 

to change the word ‘‘should’’ to the 

word ‘‘must.’’ The Coast Guard does not 

believe this change is necessary, as the 

legal requirement to submit 

amendments is clearly laid out in 33 

CFR 151.2060(c). Additionally, as 

discussed earlier in this preamble, we 

are removing the Ballast Water 

Reporting Form from the CFR (see V.A. 

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Summary of Changes from the NPRM). 

We will keep the comment in mind, 

however, and reevaluate it when we 

update the OMB approved collection as 

part of our next regularly scheduled 

renewal package. 

One commenter recommended 

revising 46 CFR 162.060–32 by changing 

‘‘appropriate dosages’’ to ‘‘appropriate 

dosages over all applicable 

temperatures’’ to reflect the fact that 

chemical and biological processes are 

temperature dependent. The Coast 

Guard agrees and has included the 

clarifying language in the final rule text. 

One commenter stated that because 

some types of treatment processes, such 

as UV, may act to make organisms 

unviable or unable to reproduce rather 

than killing them outright, the Coast 

Guard should include viability as a 

criterion for determination of BWMS 

efficacy. The Coast Guard disagrees. 

This issue has been the point of much 

discussion both in the United States and 

internationally in association with the 

IMO BWM Convention. The Coast 

Guard has decided to use live/dead 

rather than viable/unviable, because the 

latter designations would require 

culturing potentially large numbers of 

different kinds of organisms to 

determine whether they were capable of 

reproduction. This would be made even 

more problematic by the fact that 

scientists are not able to culture many 

of the organisms in question. Finally, it 

is more conservative, and thus more 

protective, to base efficacy decision on 

the basis of live/dead, rather than 

viable/unviable. 

One commenter stated, in reference to 

46 CFR 162.060–20(b)(5), that a BWMS 

should not have to record all by-passes 

of the BWMS. Rather, the commenter 

thought that such recording should be 

allowable either through electronic or 

hand entry in the logbook. The Coast 

Guard agrees and has revised the 

provision accordingly. 

One commenter stated that a strong, 

environmentally protective, 

concentration-based, numerical, 

national BWDS is a critical and 

necessary component of the nation’s 

invasive species program. The Coast 

Guard agrees. 

One commenter requested a definition 

of the term ‘‘Test Plan’’ as it is used in 

the approval text in 46 CFR 162.060– 

10(d). The Test Plan is a document that 

describes the procedures for conducting 

a test or study according to protocol 

requirements for a specific BWMS at a 

particular test site. At a minimum, the 

Test Plan includes detailed instructions 

for test procedures, sample and data 

collection, sample handling and 

preservation, precision, accuracy, goals, 

quality assurance, and quality control 

procedures relevant to the particular 

site. We have not included a definition 

of Test Plan, but we have detailed the 

necessary requirements in 46 CFR 

162.060–24. These details were 

included in the NPRM, as well. 

One commenter asked the Coast 

Guard to clarify the definition of 

‘‘change in design’’ in 46 CFR 162.060– 

16(a), and recommended following the 

same approach we used in defining 

‘‘major conversion’’ as applied to a 

vessel. Another commenter stated the 

Coast Guard should better define what 

is meant by a ‘‘design change’’ in 46 

CFR 162.060–16. 

The Coast Guard disagrees that 

additional explanation is necessary. The 

language is the same as for other 

pollution prevention equipment subject 

to Coast Guard-approval. With the 

language as it is written, any change in 

the design of an approved BWMS must 

be submitted to the Coast Guard for 

review. 

One commenter stated that the 

wording in 46 CFR 162.060–20(h) is too 

inflexible, and that the paragraph’s goals 

could be achieved through assessments 

of individual systems. The Coast Guard 

disagrees. The requirements in 46 CFR 

162.060–20(h) are important for the safe 

and effective operation of BWMS. If a 

developer considers that the 

requirements may be best met through 

other than ‘‘equipped with a means to 

* * *’’, then the developer may discuss 

alternatives with the Coast Guard. 

Responses to Questions Posed in NPRM 

One commenter stated, in response to 

the NPRM preamble question on costs, 

that it is not possible to estimate costs 

for BWMS capable of meeting higher 

stringency standards because such 

systems do not exist. The Coast Guard 

is currently undertaking additional 

studies to estimate the costs of BWMS 

capable of meeting more stringent 

standards. 

One commenter stated, in response to 

another NPRM preamble question, that 

it is not feasible to assess whether 

BWMS are sufficiently scalable to be 

able to meet multiple stringency 

standards until methods and facilities 

capable of testing to the more stringent 

standards are available. The Coast 

Guard agrees that more exacting 

methods and improved facilities are 

needed to test to the more stringent 

standards. 

One commenter responded to a 

specific question on industry readiness 

to implement the phase-two standard by 

stating that ILs and vendors are ready to 

implement the phase-two standard in 

2014 (in place of phase-one). The Coast 

Guard disagrees with this comment. To 

date, there are no ILs (as defined in this 

rule), nor to the knowledge of the Coast 

Guard are there test facilities or vendors 

that have demonstrated their readiness 

to implement the phase-two standard in 

2014. We again note the conclusion of 

the EPA SAB that test methods are not 

available to determine whether a BWMS 

meets any standard more stringent than 

the IMO’s. 

4. Approval Protocols 

General 

Two commenters said that they would 

accept a greater chance of type two 

statistical errors in determining whether 

BWMS were working effectively. The 

Coast Guard disagrees. A type two 

statistical error is when one accepts a 

null hypothesis (a hypothesis that is 

false) as true. In the case of approving 

BWMS, this would mean increasing the 

probability of approving a BWMS when 

it does not actually meet the BWDS. 

Five submitters commented on the 

make-up of test organisms in challenge 

water, and on the use of cultured 

organisms. Two commenters 

recommended that specific 

concentrations of organisms be required 

in challenge conditions. One advocated 

requiring challenge water to have 100 

times the threshold concentrations in 

the BWDS (for example, 1,000 

organisms larger than 50 micrometers 

per m3 for phase one and 1 organism 

larger than 50 micrometers per m3 for 

the phase-two standard). The other 

commenter stated that the Coast Guard 

should establish minimum test 

conditions of 50,000 organisms larger 

than 50 micrometers per m3 of water for 

all trials, with at least three trials having 

more than 100,000 organisms per m3 of 

water; 1,000 organisms per m3 of water 

for organisms between 10 and 50 

micrometers in all replicate trials, with 

at least three trials having more than 

2,000 organisms per m3 of water; 10,000 

colony forming units (cfu) of 

heterotrophic bacteria per mL of water; 

total suspended solids of 25 mg per L; 

dissolved organic carbon of 5 mg per L, 

and particulate organic carbon of 5 mg 

per L. 

The Coast Guard disagrees and will 

not make these specific changes. The 

Coast Guard based the approval 

challenge conditions on those in the 

ETV Protocol, which is the product of 

a consensus process based on input 

from numerous experts from a wide 

range of scientific and engineering 

disciplines. As such, the ETV Protocol 

constitutes the best available validated 

procedure for evaluating BWMS. The 

issues raised by the commenters were 

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considered in the development of the 

ETV Protocol. 

Two commenters called for 

publication of the testing protocols and 

procedures used by ILs prior to 

implementation of the phase-one 

standard in order to ensure 

transparency. The Coast Guard agrees 

with this comment. This final rule, as 

well as the NPRM before it, describes, 

in detail, the procedures and protocols 

for use by ILs in testing BWMS for 

purposes of type approval (see 46 CFR 

part 162.060). 

One commenter stated the Coast 

Guard should review and revise the 

protocols for assessing biological and 

operational performance and 

environmental soundness of systems 

annually. The commenter further stated 

the reviews should be based on findings 

from type approvals, compliance tests, 

and independent research, and that 

these findings should be made publicly 

available in a database maintained by 

the Coast Guard and the EPA. 

The Coast Guard agrees that the 

protocols should be reviewed regularly 

and that the performance data for 

BWMS should be publicly available, 

consistent with applicable privileges 

covering commercially sensitive 

information. 

The Coast Guard disagrees that review 

and revision should occur annually and 

that performance data should 

necessarily be made available through a 

database. Under NISA, the Coast Guard 

must assess and as appropriate revise 

our ballast water regulations at least 

every 3 years. It remains to be seen what 

the most efficient and practicable 

method will be for making performance 

data available to the public. As the U.S. 

approval process evolves, we will 

evaluate the most efficient means for 

making information available to the 

public, as well as the appropriate time 

frame for conducting reviews. 

Two commenters stated that the Coast 

Guard should base the approval testing 

and certification procedures on those 

laid out in the G8 guidelines and 

Procedure for Approval of Ballast Water 

Management Systems that make use of 

Active Substances (G9) (G9 procedure), 

which were developed to assist 

implementation of the IMO BWM 

Convention. The Coast Guard agrees 

with these commenters to a certain 

extent. The Coast Guard attempted to 

harmonize our type-approval 

procedures with these references to the 

extent practicable, and the proposed 

type-approval procedures do not 

conflict with those under the IMO BWM 

Convention. However, the G8 guidelines 

in particular are very unspecific on 

important details, subject to 

interpretation by individual 

administrations, and do not wholly 

reflect advances in ballast water science 

and technology that have occurred since 

the adoption of the G8 guidelines in 

2005. The G9 procedure addresses the 

acceptability of chemicals used to treat 

ballast water. The closest parallel to the 

G9 procedure in the United States is the 

registration of biocides under FIFRA, 

which is administered by the EPA, not 

the Coast Guard. 

Three submitters addressed the need 

for the Coast Guard’s approval 

application review process to be 

completed in a timely fashion. Two of 

these three called for the Coast Guard to 

specify, in the regulations, the 

timeframes for review and approval of 

BWMS. The Coast Guard disagrees that 

the timeframe for review and decision 

should be specified in the regulation. A 

number of the components of the 

approval process, including 

environmental reviews and reviews to 

be completed by other Federal agencies, 

are inherently not amenable to pre-set 

timeframes. The Coast Guard 

appreciates the importance of 

minimizing the time required for review 

of applications, and will make efforts to 

do so. 

EPA ETV Protocol 

Six commenters urged the Coast 

Guard to release a final version of the 

EPA ETV Protocol for verification of 

BWMS. We agree that the final ETV 

Protocol is a key component to this rule 

and, as discussed previously, we have 

incorporated it by reference into our 

final rule at 46 CFR 162.060–5. We note 

that EPA released the ETV protocol in 

September 2010, and that it is available 

on the ETV web page (http:// 

www.epa.gov/nrmrl/std/etv/ 

vp.html#wqpc). 

Two commenters urged the Coast 

Guard to use the EPA ETV Protocol as 

the basis for the approval tests to assess 

performance of BWMS in meeting the 

BWDS. Conversely, one commenter did 

not support the use of the revised ETV 

Protocol as the basis of the approval test 

procedures. The Coast Guard has 

adopted the ETV Protocol. The ETV 

Protocol is the product of a consensus 

process based on input from numerous 

experts from a wide range of scientific 

and engineering disciplines. As such, 

the ETV Protocol constitutes the best 

available validated procedure for 

evaluating BWMS. 

The Coast Guard will work with EPA 

and other stakeholders to update the 

ETV Protocol as necessary and 

appropriate in the future. If future 

updates are made, we would update our 

rules and policies as necessary to reflect 

the ETV Protocol to be used in the U.S. 

approval process. 

Two commenters called for the Coast 

Guard to define protocols and methods 

for approval testing that are clear and 

practicable. One commenter requested 

that Coast Guard do this prior to the 

implementation of the approval process. 

In this final rule, the Coast Guard has 

established procedures to be followed 

for shipboard testing as well as adopting 

the ETV Protocol. We believe these 

regulations are clear, but also anticipate 

issuing guidance to help manufacturers 

and vendors work their way through the 

U.S. approval process. 

One commenter considered the 

proposed requirements for type 

approval to be thorough and well done. 

The Coast Guard notes their submission 

and endorsement of the protocols. 

Land-Based Testing 

One commenter stated that the landbased test protocols should include a 

requirement that the concentration of 

organisms in the discharge from control 

tanks be at least ten times the discharge 

limit set by the BWDS. 

One commenter recommended the 

Coast Guard should consider requiring 

three short-term tests (18–24 hrs) and 

five 3–5 day tests at each of the required 

test facilities to enhance certainty that 

treatment systems will be effective over 

a range of voyage durations. 

One commenter stated that required 

holding times for land-based tests 

should be 5 days, but that longer or 

shorter periods should be added as 

warranted by specific BWMS. 

The Coast Guard disagrees and will 

not make these specific changes. The 

Coast Guard based the approval 

requirements for land-based testing on 

those in the ETV Protocol, which is the 

product of a consensus process based on 

input from numerous experts from a 

wide range of scientific and engineering 

disciplines. As such, the ETV Protocol 

constitutes the best available validated 

procedure for evaluating BWMS. The 

issues raised were considered in the 

development of the ETV Protocol. 

One commenter stated that test tanks 

should be the unit of replication and 

that inline integrated samples of at least 

5 m3 for organisms larger than 50 

micrometers, 5 L for both organisms 10– 

50 micrometers and bacteria, and 

indicator microbes should be collected 

for analysis. The Coast Guard disagrees 

that test tanks should be the unit of 

replication. Requiring multiple 

operations of the BWMS provides a 

useful test of the system’s ability to 

work consistently. The Coast Guard also 

disagrees that the recommended 

minimum volumes for sample sizes 

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should be established in the regulation. 

The ETV Protocol addresses how to 

determine the necessary sample 

volumes for a test. 

One commenter disagreed with the 

proposed requirements for testing intank (batch) treatments, and specifically 

proposed that a maximum of 10 m3 of 

water would be sufficient. The Coast 

Guard disagrees. The requirement for a 

minimum of 200 m3 of water reflects the 

importance of testing BWMS at a scale 

relevant to their intended use. Testing a 

BWMS intended for use on vessels 

using hundreds, if not tens of 

thousands, of cubic meters of ballast 

water by only using the BWMS to treat 

a few cubic meters would not 

adequately allow a determination of 

whether the system would work 

effectively to provide the necessary dose 

to the entire volume requiring 

treatment. 

Three commenters discussed the 

difficulties of making determinations of 

live/dead status of organisms as part of 

approval testing, particularly for 

organisms in the 10–50 micrometers 

size range. The Coast Guard 

acknowledges the identified difficulties. 

The Coast Guard points out that the ETV 

Protocol, incorporated by reference in 

this final rule, on which the approval 

testing requirements are based, includes 

a multi-stain process because of these 

difficulties. 

One commenter stated that methods 

for testing to the phase-two standard are 

not necessary, and that ‘‘interim 

enforcement standards’’ such as the use 

of a system approved as achieving some 

measurable concentration, would 

suffice. 

As discussed in this preamble, this 

final rule only contains requirements for 

the phase-one standard (see V.A. 

Summary of Changes from the NPRM). 

We will consider all of the comments 

that we received on the phase-two 

standard as we draft a notice or other 

rulemaking document that addresses the 

phase-two standard. 

Two commenters stated that 

simultaneous filling of treatment and 

control tanks during land-based testing 

should be required to assure 

comparability between the two, saying 

that sequential fills could result in 

different compositions and 

concentrations. The Coast Guard 

disagrees with the recommendation. 

Either simultaneous or sequential filling 

is allowed. The purpose of the control 

tanks is not to compare directly with 

treatment tanks, but to control for 

unexplained sources of mortality. One 

may accomplish this through 

comparisons of relative change rather 

than specific changes in abundance and 

composition. 

One commenter stated that the Coast 

Guard should require five consecutive 

successful trials during land-based 

testing. The commenter specified that 

such successes must demonstrate 

below-threshold concentrations of living 

organisms, acceptable discharge 

toxicity, and absence of mechanical 

failures. The commenter added that 

more than two failures of any kind 

during testing should result in the Coast 

Guard requiring the BWMS to be 

removed from the test facility for 

refinement. 

The Coast Guard notes that the NPRM 

did require five consecutive successful 

trials, a requirement that is retained in 

this final rule. The issue of when to 

cease testing on the basis of failures is 

a contractual issue between the 

manufacturer and the IL. It is important 

to note that the Coast Guard typeapproval procedures require the results 

of all testing, including failures, be 

included in the Test Report. 

One commenter stated that land-based 

test protocols should be updated 

regularly, and that approval results 

should be correlated with subsequent 

performance on vessels (as revealed by 

compliance assessments). The Coast 

Guard agrees with the commenter. 

Testing protocols used for type approval 

will be reviewed regularly, based on 

information developed by ILs, 

researchers, and the Coast Guard during 

enforcement actions. However, the 

Coast Guard has no plans to establish a 

specific review period or process within 

this rule. 

Shipboard Testing 

One commenter stated that BWMS 

should demonstrate that they are 

capable of meeting the discharge 

standard under a range of ballast flow 

rates, as a vessel would experience 

during cargo operations. The Coast 

Guard agrees. Shipboard testing is 

included as part of the approval 

requirements, and was included in the 

NPRM, to evaluate system efficacy 

under a range of operating conditions, 

including variable flow rates. 

One commenter asked how long the 

ballast water must be held onboard 

vessels during shipboard testing. The 

Coast Guard has revised the shipboard 

testing protocol to clearly state that hold 

times are to be at least for the minimum 

time necessary to achieve full treatment 

and an acceptable discharge water 

quality, and for the time necessary for 

the vessel to conduct its normal BWM 

procedures from uptake to discharge. 

The Coast Guard has not required 

vessels conducting approval tests to 

hold treated water for specific periods of 

time. 

One commenter stated that the Coast 

Guard should rely entirely on shipboard 

testing for BWMS type approval rather 

than requiring land-based testing. The 

Coast Guard disagrees. Land-based tests 

provide an important degree of control 

that is not possible under shipboard 

conditions. A comprehensive test 

regime that integrates land-based and 

shipboard testing provides the best 

evidence that a BWMS will likely 

perform satisfactorily once it is installed 

on a wide range of ships and operated 

under a wide range of challenging 

conditions. 

Eleven commenters stated the 

proposed duration for shipboard testing 

(12 months, ten test cycles, or both) 

would be onerous and unnecessary. 

Three of the commenters specifically 

recommended the Coast Guard use the 

6 month requirement of the G8 

guidelines. The Coast Guard agrees with 

these comments and has revised the 

regulation accordingly. 

Six commenters stated that the 

shipboard testing requirement of three 

geographic regions is too difficult to 

achieve on many vessels. Two 

commenters further recommended the 

Coast Guard follow the IMO or 

Shipboard Technology Evaluation 

Program (STEP) approaches for 

shipboard testing. The Coast Guard 

agrees and the shipboard testing 

protocols have been revised 

accordingly. 

One commenter recommended that 

shipboard testing procedures 

incorporate sampling and analysis 

procedures similar to those used for 

land-based testing, to the degree 

possible and appropriate. The Coast 

Guard agrees with the general point. 

The shipboard testing procedures have 

been developed to make use of the same 

procedures as land-based to the degree 

appropriate. 

One commenter recommended the 

Coast Guard allow systems to be tested 

on multiple vessels. The Coast Guard 

neither prohibits nor requires testing on 

multiple vessels. 

Two commenters stated that 

shipboard testing should focus on 

operational performance parameters, 

rather than repeating the experimental 

testing performed on land. The Coast 

Guard notes that the shipboard testing 

requirements include assessing 

operational parameters as well as testing 

system efficacy in meeting the BWDS, 

but do not require the same level of 

experimental control as for the landbased testing. 

Two submitters commented generally 

on the inclusion of a requirement for 

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shipboard testing. One considered the 

requirement to be unnecessary, given 

land-based testing is also required, 

while the other considered the 

requirement for shipboard testing to be 

completely appropriate. The Coast 

Guard agrees with the commenter who 

supported the inclusion of shipboard 

testing. Shipboard tests are intended to 

assess system performance under 

operational conditions, over a period of 

extended use. As such, shipboard tests 

are not repetitions of land-based tests 

and are necessary for effective approval 

evaluation. 

One commenter recommended that 

safety and operational reliability aspects 

of approval testing should be dropped. 

The commenter believed that vessel 

owners and their consultants are 

capable of assessing these issues on 

their own. The Coast Guard disagrees; 

assessment of the suitability of 

equipment for shipboard circumstances 

is a fundamental aspect of the approval 

process. 

Phase-Two Testing 

Seven commenters involved in 

developing or testing BWM technologies 

stated that no methods appropriate for 

measuring BWMS’ capability to meet 

the phase-two standard are currently 

available. The Coast Guard agrees that 

more developed methods and improved 

facilities are needed to more effectively 

test to the more stringent standards. 

This is one of the reasons we have 

deferred issuance of a more stringent 

phase-two standard. 

One State commenter asserted that 

initial data from technology developers 

indicate that laboratories can test 

BWMS’ ability to meet the phase-two 

standard. The Coast Guard disagrees 

with this interpretation of the available 

data. The Coast Guard has not seen 

quantitative validation that any 

laboratories can currently measure the 

ability of BWMS to meet the phase-two 

standard. 

Salinity Classes 

One commenter stated that BWMS 

should be tested for type approval in at 

least two of three salinity classes, but 

that the proposed 10 practical salinity 

unit (PSU) difference between salinity 

classes should not be required. Two 

commenters stated that the Coast Guard 

should require land-based testing of 

BWMS at three locations with different 

salinities. 

The Coast Guard agrees that BWMS 

should be approved for the salinity 

regimes in which they will be used, and 

we have written the approval 

procedures to allow the manufacturer or 

vendor to determine in which salinity 

class(es) they will test their BWMS. The 

U.S. type approval will only apply to 

the salinity class for which the BWMS 

passed testing. This will allow some 

manufacturers to forego the cost of 

testing in freshwater, for example, if 

they do not expect to find a market in 

that salinity class. 

Six submitters commented on the 

requirements for BWMS approved for 

freshwater use, and stated that such 

systems should be required to undergo 

testing in a land-based facility with 

natural freshwater challenge water. One 

of these commenters also stated that 

BWMS approved for use in the Great 

Lakes should be tested in the Great 

Lakes. 

The Coast Guard agrees that systems 

type approved for use in freshwater 

should be tested in freshwater, and has 

clarified the requirements accordingly. 

The Coast Guard disagrees that we 

should require such freshwater BWMS 

testing in the Great Lakes. In many 

cases, BWMS treating ballast water that 

will be discharged in the Great Lakes 

will be doing so with water taken on 

outside the Great Lakes. 

Sampling 

One commenter stated that 

approaches for statistically-sound 

sampling to identify with confidence 

when a BWMS can meet phase-one 

limits in land-based and shipboard 

testing still require some refinement. 

The commenter identified number and 

volume of samples as two specific areas 

of concern. The Coast Guard agrees, and 

has incorporated additional 

requirements on sampling design in the 

testing protocol. 

One commenter requested a different 

definition of ‘‘representativeness’’ in 46 

CFR 162.060–3. The Coast Guard agrees 

that this definition needed refining, and 

we have replaced it with the term 

‘‘representative sample,’’ which has a 

new definition. With respect to samples 

obtained in testing, a representative 

sample is a random sample in which 

every individual of interest in the larger 

population (organisms, molecules, etc.) 

has an unbiased chance of appearing in 

the sample. 

Test Organisms 

One commenter stated the Coast 

Guard should identify a list of microbes 

and appropriate microbial 

concentrations in challenge water for 

use in BWMS approval tests and then 

authorize vendors to add these 

organisms into the vessels’ ballast water 

during shipboard tests. The Coast Guard 

disagrees. The use of added organisms 

in shipboard tests could, besides being 

extremely complicated and difficult, 

result in the risk of NIS introductions. 

One commenter asked why the Coast 

Guard does not provide a list of specific 

test microbes for use in testing the 

efficacy of BWMS. The Coast Guard 

notes that, while standard test 

organisms are widely used in drinking 

and wastewater regulations, several 

constraints prevent them from being 

deemed appropriate for testing BWMS. 

First, there is no agreed list of organisms 

that would adequately represent all of 

the different kinds of organisms found 

in ballast water. Secondly, even for 

those organisms that have been 

identified as potential candidates for 

such use, there are concerns about 

difficulties associated with culturing the 

numbers needed for full-scale testing. 

Another concern is the potential for 

release of such organisms into the 

environment, given that the specific 

organisms would not be native in many 

places where testing would occur. 

One commenter recommended that 

the Coast Guard develop a list of the 

conditions necessary for each BWMS to 

kill or inactivate the most resistant 

organisms representative of ballast 

water composition. The commenter 

cited work by NSF International, Old 

Dominion University, and University of 

Washington that identifies several 

candidate organisms for such use. The 

Coast Guard is aware of the cited work, 

which was conducted in support of the 

joint Coast Guard and EPA ETV Protocol 

efforts to identify appropriate standard 

test organisms for land-based BWMS 

tests. The Coast Guard disagrees that 

these organisms should be used as part 

of shipboard testing. We do not believe 

that using these organisms as part of 

shipboard testing would be practicable 

to develop a comprehensive 

understanding of the conditions 

necessary for each BWMS to kill or 

remove organisms. 

Acceptance of Already-Tested BWMS 

Two commenters proposed, as a way 

to avoid delays in the availability of 

approved BWMS, that the Coast Guard 

grant type approval to BWMS that have 

undergone prior testing by a variety of 

U.S. government-sponsored research 

programs or by independent 

researchers. The Coast Guard partly 

agrees. The Coast Guard shares the 

commenters’ concerns about avoiding 

delays. We have included a provision 

under which U.S. type approval can be 

based on testing performed under 

protocols other than those specified in 

this final rule, provided that the testing 

determined to be equivalent to the U.S. 

type approval procedures. If BWMS 

developers have conducted substantive 

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testing prior to the availability of ILs, 

the developers can request a review and 

determination of equivalency by the 

Coast Guard. This review will be 

conducted in the same fashion as the 

assessment of foreign approval 

programs. 

Two commenters stated that the Coast 

Guard should accept any testing 

protocol or procedure established or 

accepted by a number of different U.S. 

and foreign entities as equivalent to the 

proposed approval testing. The Coast 

Guard disagrees. The Coast Guard will 

evaluate the degree to which other 

testing protocols are equivalent to those 

implemented under this rule on a caseby-case basis, and will make decisions 

about equivalencies accordingly. 

One commenter asserted that the 

Coast Guard should not require retesting 

of previously approved BWMS when 

new test methods are established. The 

Coast Guard agrees that retesting should 

not be automatically required of all 

BWMS approved under previous testing 

requirements. However, the Coast Guard 

will retain the right to require retesting 

of specific BWMS if subsequent 

information indicates the previously 

approved systems may not, in fact, 

effectively reduce the concentrations of 

organisms in vessels’ ballast water. 

One commenter stated that vessels 

enrolled in STEP should be 

grandfathered and not subjected to 

further equivalency evaluations under 

the approval process, since a BWMS 

accepted into STEP has been vigorously 

reviewed by the Coast Guard and will 

continue to be evaluated through the 

period of STEP participation. The 

commenter offered the opinion that 

requiring companies that have gone 

through the STEP process to meet 

additional requirements will constitute 

a punishment for acting proactively. 

The Coast Guard agrees that vessels 

accepted into STEP should not be 

subjected to additional requirements 

associated with the use of type 

approved BWMS. However, the Coast 

Guard clarifies that STEP applies to 

vessels, not to BWMS. Thus, a vessel 

with a specific BWMS accepted into 

STEP is allowed to use that system as 

long as the vessel remains in good 

standing within STEP, regardless of 

whether the BWMS is granted type 

approval. Under this provision, it is use 

of the BWMS that constitutes meeting 

BWM requirements, not meeting the 

BWDS. The Coast Guard considers a 

vessel in STEP to be in Good Standing 

if the vessel has met reporting 

requirements, has or is engaged in 

testing the system in accordance with 

the accepted test plan, and is using the 

BWMS to treat all ballast water 

discharged to waters of the U.S. 

One commenter proposed that 

information submitted for acceptance 

into STEP should be considered to meet 

the requirements for an approval 

application, saying that an applicant for 

type approval should be able to simply 

reference information previously 

submitted in a STEP application. The 

Coast Guard disagrees. Applicants for 

approval may submit copies of materials 

previously submitted for acceptance to 

STEP, providing that the approval 

application adequately references the 

pertinent sections of the STEP 

application materials. To do this, the 

applicant must include copies of any 

referenced STEP materials in the 

approval application. The applicant is 

responsible for submitting a complete 

approval application to the specified 

Coast Guard office. 

One commenter proposed that a safety 

certification by any recognized ship 

classification society or flag state 

member of IMO should be considered 

conclusive proof that the so-certified 

BWMS is safe for use in vessels at sea. 

The Coast Guard disagrees. The Coast 

Guard has proposed a provision for 

acceptance of type approvals by foreign 

administrations, and will evaluate the 

procedures and criteria used in such 

approvals prior to accepting them as 

equivalent to Coast Guard requirements. 

Importantly, biocides may also require 

registration by the EPA under FIFRA 

and other statutes and must meet 

discharge limits established under 

EPA’s Vessel General Permit. 

Environmental Analyses of BWMS 

Four commenters expressed concern 

that Coast Guard NEPA and ESA 

evaluations and EPA FIFRA evaluations 

will significantly delay the approval 

process, and hence the rate at which 

type-approved technologies can be 

brought to the market. The commenters 

made specific recommendations to 

minimize delays, including taking a 

programmatic approach to NEPA 

assessments for approval decisions, 

starting NEPA assessments at the time a 

developer first approaches the Coast 

Guard, maintaining a publicly available 

database of releasable NEPA assessment 

information that can be used in 

subsequent assessments, and integrating 

Coast Guard and EPA data and analysis 

requirements that stem from different 

programs. 

The Coast Guard agrees that the 

analyses identified by the commenters 

could take a significant amount of time 

to complete. The Coast Guard already 

makes use of existing NEPA 

documentation to the degree 

appropriate when conducting the 

required assessments. We also conduct 

programmatic assessments, when 

appropriate, to avoid redundancies. The 

Coast Guard and EPA will seek to 

integrate or harmonize the analysis 

conducted under their separate statutory 

requirements to the maximum extent 

practicable. The Coast Guard and EPA 

are coordinating closely to identify 

opportunities to avoid or limit 

redundancies in our respective 

programs. 

One commenter, a Federal agency, 

recommended that the Coast Guard 

explicitly state that national-level 

environmental analyses, including U.S. 

Fish and Wildlife and National Marine 

Fisheries Service review and response 

times, will most likely take months or 

years. The Coast Guard agrees that these 

reviews could take a significant amount 

of time, but we are working closely with 

our Federal agency partners to 

streamline these review and approval 

processes. 

Miscellaneous Comments on the 

Approval Process 

Two BWMS developers stated that the 

Coast Guard must clarify that type 

approval will apply to a specific BWMS, 

not to a specific manufacturer, and 

further stated that it should be the 

approval holder’s responsibility to 

ensure that BWMS production units 

meet quality control specifications. The 

Coast Guard agrees that type approval 

applies to a specific BWMS rather than 

manufacturers, and reviewed the 

regulatory text to ensure it was clear on 

this point. We did not see a need to 

make any changes to the regulation in 

order to clarify this. The Coast Guard 

disagrees that type approval should not 

include examination of BWMS 

production unit manufacturers. The 

Coast Guard’s approval procedures for 

other marine equipment include 

examinations of a manufacturers’ ability 

to fabricate production units that 

conform to the design and specifications 

of the type-approved unit. This will be 

a fundamental component of the Coast 

Guard’s BWMS approval process. 

One commenter stated that 

classification societies, such as the 

American Bureau of Shipping or Bureau 

Veritas, should be able to review 

changes to approved BWMS and 

determine whether or not recertification is necessary. The Coast 

Guard disagrees. Under the existing 

process for type approvals, all changes 

to the design or construction of typeapproved equipment must be submitted 

to the Coast Guard for review. 

One commenter recommended that 

documentation submitted for type 

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approval in accordance with the IMO 

BWM Convention should be accepted as 

meeting the requirements for Test 

Reports in 46 CFR 162.060–34(b)–(f). 

The Coast Guard agrees that documents 

prepared in accordance with approval 

requirements under the IMO BWM 

Convention may be used in an 

application for type approval under the 

Coast Guard’s regulation. However, 

these documents must demonstrate that 

the tested BWMS meets the BWDS and 

that the test protocols used are 

equivalent to the U.S. approval process. 

Such documents must be included in 

the approval application package and all 

references to data or other information 

in the documents submitted for IMO 

approval must refer to specific sections 

and pages. 

One commenter asserted that the 

proposed approval procedures will 

guarantee a government-created, 

shortage of available technology. The 

Coast Guard disagrees with this 

perspective. By type approving 

treatment technologies in accordance 

with rigorous and credible test 

procedures and requirements, the Coast 

Guard will create a class of treatment 

options in which vessel owners and 

operators can have a high degree of 

confidence. Without sufficient testing 

requirements, vessel owners and 

operators would have no means beyond 

vendors’ claims of assessing whether a 

BWMS on the market is likely to be 

effective or not. 

One commenter requested that the 

Coast Guard clarify whether BWMS 

undergoing type approval will need to 

demonstrate efficacy in meeting both 

the phase-one and phase-two standards. 

The Coast Guard clarifies that type 

approval under the final rule will focus 

on assessing the efficacy of the BWMS 

in meeting the phase one standard. The 

data generated from these tests may or 

may not provide information on the 

ability of the BWMS to meet more 

stringent standards. 

One commenter recommended that 

the Coast Guard require that BWMS 

approval testing involve full-production 

units with full installation, operation, 

and maintenance manuals, and be 

operated by test facility staff or the 

vessel crew during tests to ensure that 

generally installed systems have a high 

probability of working effectively. The 

Coast Guard agrees. The approval 

requirements have been revised to 

clarify that tests must be conducted on 

production units installed in the 

manner intended for normal shipboard 

operation and that systems must be 

operated by ILs during land-based 

testing and vessel crews during 

shipboard testing. 

One commenter stated that the 

approval procedures should incorporate 

BWMS type approval for a rated 

capacity range, similar to that contained 

in the G8 guidelines. The Coast Guard 

agrees with the recommendation, and 

has revised the approval procedure 

accordingly. 

One commenter disagreed with the 

Coast Guard’s proposal in 46 CFR 

162.060–18 that type approval could be 

suspended or withdrawn if the BWMS 

is no longer manufactured or supported 

by the manufacturer. The commenter 

stated their belief that this would be 

unreasonably punitive to shipowners, 

and that properly maintained and 

operating systems should be acceptable 

regardless of the manufacturer’s status. 

The Coast Guard takes this 

opportunity to clarify that a typeapproved system no longer 

manufactured or supported by the 

manufacturer would not automatically 

lose its type approval. However, use of 

parts or materials not specified for the 

originally type-approved system may 

trigger a design change review under 46 

CFR 162.060–16. 

One commenter stated that the 

proposed requirements for testing and 

approving BWMS were excessively 

complex, expensive, unnecessary for the 

purpose of proving effectiveness or 

vessel safety, and likely to delay 

installation of certified equipment. The 

Coast Guard disagrees. The general 

process of land-based and shipboard 

testing for approval of BWMS has been 

widely discussed and accepted 

internationally. The Coast Guard has 

reconsidered alternatives to specific 

sections of the approval process and the 

determinations and resolutions of these 

considerations are described in this 

preamble in section V.B. Discussion of 

Comments. 

One commenter called for IL Test 

Reports submitted in association with a 

request for approval of a BWMS to be 

made electronically available to the 

public immediately after they are 

submitted to the Coast Guard. The Coast 

Guard disagrees that test data should be 

made publicly available immediately 

upon application, as such data may 

include confidential business 

information and other privileged 

information, which is not subject to 

public release under the Freedom of 

Information Act (5 U.S.C. 522). Test 

Reports, or appropriate portions thereof, 

will be made public as part of the 

approval procedure when the Coast 

Guard announces a proposed decision 

on an application. 

5. Legal 

Preemption of State Action 

Twelve commenters directly 

requested that the Coast Guard preempt 

all State ballast water treatment 

standards and requirements in favor of 

a uniform, national, water quality-based 

treatment standard. One commenter 

argued that numerous States are already 

unconstitutionally burdening interstate 

commerce with conflicting State BWM 

regulations. The commenter noted that 

interstate shipping will quickly become 

impossible if the Coast Guard fails to 

preempt all State treatment regulations 

and likened the patchwork of State 

regulations to a ‘‘destructive economic 

balkanization.’’ Another commenter 

agreed with this sentiment, stating that 

without preemption, BWM regulations 

on a State-by-State basis create the 

potential to restrict trade and severely 

impact the economies of ‘‘nearly every 

State which relies on waterborne 

commerce.’’ 

Another of the commenters requesting 

Federal preemption of BWM regulation 

noted that different rules for different 

States or regions within the United 

States will create confusion and delays 

in the primary objective of eliminating 

aquatic NIS invasions. Two of the 

commenters quoted a resolution passed 

by the Great Lakes Commission in May 

of 2007 which urged a Federal ballast 

water treatment regime that would 

preempt States. One commenter called 

the idea of preemption by the Coast 

Guard ‘‘a very positive step.’’ 

One of the commenters requesting 

Federal preemption noted that Federal 

standardization of the methodology and 

technological requirements of BWM is 

integral to the future success of any 

ballast water treatment regime. Another 

commenter argued that the varying State 

standards have already created a 

patchwork of requirements that are 

economically inefficient, highly 

cumbersome to implement, and 

unproven in regards to prevention of 

aquatic NIS invasions. 

Three commenters approved of and 

agreed with our determination to not 

preempt State BWM standards. One of 

these commenters noted that the Federal 

regulations should set a minimum 

compliance standard applicable to all 

waters of the United States but allow the 

States to enact stronger water quality 

standards applicable to their own 

waters. Another noted that States only 

began implementing their own 

standards after what they called 

‘‘decades of delay and inaction at the 

Federal level.’’ 

One commenter agreed that lack of 

Federal action in regard to 

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implementing a BWDS caused States to 

step in and begin regulating. This 

commenter, however, also urged for 

Federal preemption of even those 

already implemented State standards. 

One commenter urged the Coast 

Guard to seek passage of a single 

Federal law which would preempt all 

State and any other Federal laws. 

Another commenter urged the Coast 

Guard to advocate to Congress the need 

to preempt States’ BWM laws and to 

coordinate U.S. standards with 

international standards. 

As we noted in the NPRM and again 

in section VII.E. Federalism of this 

preamble, NANPCA, as amended by 

NISA, contains a ‘‘savings provision’’ 

that saves to the States their authority to 

‘‘adopt or enforce control measures for 

aquatic nuisance species, [and nothing 

in the Act would] diminish or affect the 

jurisdiction of any States over species of 

fish and wildlife.’’ 16 U.S.C. 4725. In 

light of this provision, the Coast Guard 

cannot legally preempt State action to 

regulate discharges of ballast water 

within State waters. 

One commenter noted the statutory 

restriction, but urged the Coast Guard to 

work with States to harmonize BWDS, 

noting that regulatory consistency 

between State, Federal, and 

international requirements is a critical 

component to moving forward in the 

field of BWM. Two other commenters 

also urged the Coast Guard to work with 

individual States, but argued for Federal 

preemption as well. 

The Coast Guard agrees that we must 

work with the States, as our statutory 

authority clearly envisions a Federal/ 

State partnership. We have been in 

frequent contact with representatives 

from all of the States which have 

already implemented their own BWDS. 

We will continue to work with these 

contacts in an attempt to harmonize 

BWDS as much as we can. 

Unified Federal Action 

Two commenters urged the 

Administration to assert that these 

regulations supersede any action by the 

EPA or by States under any provision of 

the Clean Water Act. Another 

questioned whether these regulations 

would be consistent with the existing 

EPA VGP, and sought clarification. This 

commenter noted that the Coast Guard 

and EPA must be in accord in regards 

to the proper standard to apply to the 

treatment of ballast water. One 

commenter requested that the preamble 

to the NPRM be revised to include a 

discussion of the EPA VGP, and also 

urged the Coast Guard to ‘‘outline and 

cross-reference’’ the regulations with the 

EPA VGP. 

The Coast Guard agrees that, to the 

extent possible and appropriate, there 

should be consistency between Coast 

Guard and EPA ballast water 

requirements. We maintain a very close 

working relationship with EPA. We 

consulted with them on matters relating 

to the EPA VGP and we also sought 

their comments on both the NPRM and 

this final rule. NANPCA, as amended by 

NISA, and the Clean Water Act provide 

both the Coast Guard and EPA, 

respectively, with the authority to 

regulate discharge of ballast water from 

vessels. However, these statutes contain 

different language and we will continue 

to work with the EPA to ensure that, to 

the greatest extent possible, given our 

separate statutory authorities, each 

agency’s actions are consistent and do 

not work at cross-purposes to the other 

agency’s actions. 

We note that the NPRM preamble did 

briefly discuss the EPA’s 2008 VGP (74 

FR 44634), including the address for an 

EPA Web site where the reader could 

find more information. As we move 

forward and implement today’s final 

rule, we will work closely with EPA to 

try and provide a type of ‘‘crosswalk’’ 

guidance between Coast Guard 

regulations on ballast water discharge 

and EPA’s VGP. 

Thirty-one commenters supported 

establishing a uniform, protective, 

national standard for ballast water 

discharge from vessels calling at U.S. 

ports. Six commenters also said that it 

is vital that international shipping 

regulations, including those for ballast 

water, are standardized globally. 

However, both NANPCA, as amended 

by NISA, and the Clean Water Act allow 

for concurrent State regulatory action 

with regard to ballast water discharge. 

Compliance With NISA 

One commenter argued that the 

proposed phase-one BWDS would 

violate NISA, as it would not be at least 

as effective as BWE at preventing or 

reducing the introduction of NIS into 

waters of the United States. The 

commenter cited 16 U.S.C. 

4711(c)(D)(iii). The Coast Guard 

disagrees. As we noted in both the 

NPRM and the DPEIS, the effectiveness 

of BWE varies widely, not only from 

vessel to vessel but also on individual 

vessels from voyage to voyage. Given 

the wide range of effectiveness of BWE 

moving from a scheme where you might 

get a poor BWE or none at all, if the 

vessel faced safety hazards, to one 

where all technologies would be tested 

and certified as meeting the BWDS, 

provides a level of protectiveness that is 

not only at least as effective as BWE, but 

in many cases much better than BWE. 

Two commenters argued that legal 

precedent interpreting the phrase 

‘‘maximum extent practicable’’ limits 

the proposed practicability review to 

considering one factor: Technological 

feasibility. These commenters cited 

several Federal court cases to bolster 

their argument. (Biodiversity Legal 

Foundation v. Babbit, 146 F.3d 1249 

(10th Cir. 1998); Fund for Animals v. 

Babbitt, 903 F. Supp. 96, D.D.C. 1995); 

Wyoming v. United States, 279 F.3d 

1214 (10th Cir. 2002)). 

The Coast Guard disagrees with the 

commenters’ interpretation of the cited 

cases. In each of these cases, the 

deciding court noted that the phrase ‘‘to 

the maximum extent practicable’’ 

certainly limits agency discretion. 

However, the United States Court of 

Appeals for the Tenth Circuit noted in 

the Biodiversity decision that the phrase 

itself is ‘‘facially ambiguous.’’ 

(Biodiversity, 146 F.3d 1249 at 1254.) In 

such a scenario, where the statutory 

mandate is ambiguous, courts must 

defer to an agency’s interpretation so 

long as that interpretation is 

permissible. See Chevron U.S.A., Inc. v. 

Natural Resources Defense Council, 

Inc., 467 U.S. 837, 842–43 (1984). 

Interpreting ‘‘maximum extent 

practicable’’ to include factors other 

than technological feasibility is 

permissible. If Congress had wanted to 

limit the Coast Guard’s review to 

technological feasibility alone, it 

certainly could have done so but did 

not. 

‘‘Practicable’’ is defined as ‘‘that 

which is performable, feasible, [or] 

possible.’’ Biodiversity at 1254, citing 

Black’s Law Dictionary 1172 (6th ed. 

1991). In order to determine whether a 

proposed phase-two standard or any 

standard higher than phase-one is 

performable, feasible, and/or possible, it 

will be necessary to look at more than 

just technological feasibility. Whether a 

standard is practicable could also 

require, among other factors, a 

determination as to whether the 

technology is effective, can be 

implemented by vessels required to 

meet the BWDS, which necessarily 

includes a review of whether that 

technology can be produced in large 

enough quantities to be installed on 

those vessels, the probable duration of 

that installation period, whether vessel 

owners can afford to install the 

technologies, and, if they cannot, what 

the potential ramification on the 

national transportation system might be 

if vessel owners opt to go out of 

business instead. 

Two commenters argued that the 

language from NANPCA directing 

regulation of vessels entering the Great 

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Lakes from outside of the EEZ (16 U.S.C. 

4711(b)) does not allow for the proposed 

practicability review because this 

paragraph of NANPCA does not contain 

the same ‘‘maximum extent practicable’’ 

language later added by NISA for 

vessels entering waters of the United 

States in general. The Coast Guard 

disagrees. NISA was enacted to build 

upon the requirements of NANPCA; 

therefore it is proper to apply the 

practicability review to the Great Lakes 

as well. 

One commenter requested that we 

revise the preamble to the NPRM to 

explicitly state that NISA establishes the 

objective of a zero-discharge standard. 

We agree that the objective of NISA is 

to prevent the introduction and spread 

of NIS in waters of the United States, 

with caveats for doing so to the 

maximum extent practicable. We 

believe this response is consistent with 

the Coast Guard’s legal requirements 

and should satisfy the commenter’s 

concern. 

APA Concerns 

One commenter argued that the 

NPRM violated the APA because while 

the IMO Treaty (presumably the 

commenter intended to reference the 

IMO BWM Convention) allows ratifying 

countries to impose more stringent 

treatment standards if they find it a 

necessity for public health or the 

environment, the NPRM made no such 

finding. The Coast Guard disagrees with 

this comment. First, the Coast Guard is 

implementing NISA and not the IMO 

BWM Convention. While the Coast 

Guard supports international efforts for 

the prevention and control of NIS from 

ships’ ballast water, the Coast Guard is 

not under an obligation at this time to 

implement the IMO BWM Convention 

as the United States is not a Party to the 

IMO BWM Convention and there is no 

enacted domestic legislation 

implementing the IMO BWM 

Convention. Thus, the Coast Guard must 

comply with its mandate under NISA 

and applicable U.S. laws on issuing 

regulations, which we have done. 

Moreover, the BWM Convention has not 

entered into force at this time for any 

countries, even those that have ratified 

it. The Coast Guard also disagrees with 

the commenter’s characterization of the 

IMO BWM Convention’s provisions 

regarding Parties’ implementation of 

more stringent measures than those 

contained in the IMO BWM Convention. 

The IMO BWM Convention clearly 

states that: ‘‘Nothing in this Convention 

shall be interpreted as preventing a 

Party from taking * * * more stringent 

measures with respect to the prevention, 

reduction or elimination of the transfer 

of Harmful Aquatic Organisms and 

Pathogens through the control and 

management of ships’ Ballast Water and 

Sediments, consistent with international 

law’’. 

Three commenters argued that the 

regulation, particularly the 

practicability reviews, should include 

more detail in order to prevent legal 

challenges. The Coast Guard agrees that 

the regulations must not be overly vague 

in order to avoid a finding that they are 

arbitrary and capricious under the APA. 

We drafted the NPRM and have drafted 

this rule in a manner that is intended to 

eliminate vagueness. In regards to the 

practicability review, we have included 

more specific details of what the Coast 

Guard will consider; however, the 

regulation does allow for the 

consideration of additional criteria not 

listed. This is to ensure that the Coast 

Guard is not foreclosed from 

considering an issue that cannot be 

foreseen today. 

Eight commenters argued that the 

NPRM violated the APA by not 

explaining the rationale for including 

vessels that are not currently required to 

conduct BWE in the requirement to 

comply with the BWDS in the NPRM. 

They argued that the NPRM is based on 

‘‘inaccurate assumptions’’ and 

‘‘incomplete research’’ and also that the 

DPEIS and NPRM RA lacked sufficient 

rationale to justify applying the NPRM’s 

proposed requirements to vessels 

operating only on the Great Lakes or to 

barges and towing vessels operating in 

the U.S. domestic trade. 

As we have noted in this preamble, 

we have revised the applicability of this 

rule such that most vessels operating in 

the waters of the United States without 

having entered waters of the United 

States from outside the EEZ will not be 

required to comply with the BWDS in 

this rule (see V.A. Summary of Changes 

from the NPRM). In the future, and after 

further analysis, we do intend to extend 

this applicability to vessels operating in 

waters of the United States, whether or 

not they ever operate outside of the EEZ. 

We also intend to conduct additional 

research on this issue as necessary. We 

will reconsider the commenters’ 

arguments at that time and ensure that 

the public is allowed to comment on our 

information, rationale, and data before 

that extension is implemented. 

Seven commenters argued that the 

inclusion of a phase-two standard 

violated the APA, as it was arbitrary and 

capricious ‘‘on its face’’. They cited the 

lack of any factual or scientific rationale 

for its inclusion, as well as the lack of 

any discussion relevant to the phasetwo standard in either the NPRM RA or 

the DPEIS. 

Four commenters stated that the 

phase-two standard was not properly 

promulgated for appropriate scrutiny 

within the regulatory process and also 

requested the necessary economic and 

environmental analyses for other 

alternatives as part of a separate 

rulemaking that would give 

stakeholders an opportunity to provide 

meaningful comments. 

As noted in preamble section V.A. 

Summary of Changes from the NPRM, 

we are only moving forward with the 

phase-one BWDS at this time. We fully 

intend to issue regulations in the future 

that will include a more stringent 

standard, after completing additional 

research and analysis. Those future 

regulations will be supported by all 

legally required environmental and 

economic analyses, which will be made 

available to the public for comment as 

required by applicable laws related to 

Federal rulemaking. We will keep the 

commenters’ concerns in mind as we 

draft those regulations and analyses. 

Authority To Issue Regulations 

Twenty-one commenters argued that 

the Coast Guard does not have the 

authority to require vessels to comply 

with a BWDS if those vessels do not 

enter the waters of the United States 

from outside the EEZ. These 

commenters all cited the provision in 16 

U.S.C. 4711(c)(2)(D) which specifically 

allows the Coast Guard to direct a vessel 

to conduct a BWE or alternative BWM 

method if that vessel operated beyond 

the EEZ. They argued that this specific 

authority must be read to limit the 

broader grants of authority in 16 U.S.C. 

(c)(1), (c)(2)(A), (e), and (f). 

The Coast Guard disagrees that we do 

not have the statutory authority under 

NISA to regulate ballast water on vessels 

that do not operate outside of the EEZ. 

NISA requires that the Coast Guard 

‘‘ensure to the maximum extent 

practicable that aquatic nuisance 

species are not discharged into waters of 

the United States from vessels * * *.’’ 

16 U.S.C. 4711(c)(2)(A). This mandate 

includes promulgating standards for 

vessels that do not operate outside of 

the EEZ, as 16 U.S.C. 4711(c)(2)(B) 

makes NISA applicable to ‘‘all vessels 

equipped with ballast water tanks that 

operate in waters of the United States’’ 

without regard to whether those vessels 

ever operate outside of the EEZ. This is 

supported by other language in NISA, 

which is clear that ‘‘discharge,’’ in this 

context, is not limited to the 

introduction of NIS into waters of the 

United States from waters outside of the 

EEZ but also covers the internal spread 

of NIS. 

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The Coast Guard disagrees with the 

commenters’ reading of NISA, including 

their arguments that the statutory 

authority found in subparagraphs 

(c)(2)(A) and (c)(2)(B) of 16 U.S.C. 4711 

are ‘‘broad’’ grants limited by ‘‘specific’’ 

grants of other subparagraphs of 16 

U.S.C. 4711(c). The mandate included 

in 16 U.S.C. 4711(c)(2)(A) is also a 

‘‘specific’’ requirement and cannot be 

deemed a nullity by the existence of 16 

U.S.C. 4711(c)(2)(D). Subparagraph (D) 

of 16 U.S.C. 4711(c)(2) merely sets forth 

the initial ballast water requirements for 

a certain subset of vessels. Ultimately, 

the Coast Guard must read the statute as 

a whole and follow all of the paragraphs 

and subparagraphs of 16 U.S.C. 4711 

when we promulgate our BWDS under 

NISA. 

Two additional commenters noted 

that NISA requires the Coast Guard to 

take into account a variety of factors, 

including vessel types and differing 

operating conditions, when issuing 

regulations. The commenters cited 16 

U.S.C. 4711(c)(2)(H). They argued that 

by proposing a ‘‘one size fits all’’ BWDS, 

the Coast Guard violated the authority 

to regulate provided within NISA. 

The Coast Guard disagrees with the 

allegation that its BWDS violates NISA, 

but agrees that it must comply with 16 

U.S.C. 4711(c)(2)(H), just as it must 

comply with the other subparagraphs in 

16 U.S.C. 4711. A ‘‘one size fits all’’ 

BWDS would not take into proper 

consideration all of the elements of 16 

U.S.C. 4711(c)(2)(H), including the 

possibility that BWMS may not 

currently be available for all vessel 

types in all operating conditions. As 

such, the NPRM included exceptions 

and alternatives to using a BWMS for 

extraordinary circumstances, such as 

heavy weather or BWMS failure, and 

those exceptions and alternatives are 

retained in the final rule. We have also 

revised 33 CFR 151.1510 and 151.2025 

to include alternatives to using a 

BWMS. 

Tribal Impacts 

We received one comment that cited 

tribal concerns, however, the 

commenter did not raise any issues that 

would require consultation under 

Executive Order 13175, Consultation 

and Coordination with Indian Tribal 

Governments. Rather, the commenter 

noted that invasions of aquatic NIS into 

the waters of certain Great Lakes could 

cause substantial hardships to tribal 

commercial and subsistence fisheries, 

which might in turn require a 

reconsideration of a Federal courtordered Consent Decree between several 

tribes, the Federal Government, and the 

State of Michigan. 

We do not disagree with this 

assessment. We are issuing this rule in 

order to prevent NIS invasions, and the 

very hardships that the commenter 

relays. 

Technical Issues 

Two commenters questioned our use 

of the term ‘‘U.S. waters’’ in several 

sections, instead of the term ‘‘waters of 

the United States,’’ which we explicitly 

defined in the NPRM. We agree that the 

proper term should be ‘‘waters of the 

United States’’ and have revised 33 CFR 

151.1512, 151.2005, 151.2025, and 

151.2035 to use this term. 

One commenter suggested that the 

definition for the term ‘‘ballast water’’ 

be revised to state explicitly that it does 

not include water sealed in ballast 

tanks, water permanently ballasted and 

changed only in connection with 

drydocking, and water taken into ballast 

tanks from commercial or municipal 

freshwater sources. 

The Coast Guard agrees with the 

commenter and believes the final rule 

addresses the concern. The regulation, 

as written, already accomplishes the 

requested relief for the first two 

categories by allowing vessels subject to 

the requirements of 33 CFR subpart C to 

‘‘retain the ballast water onboard the 

vessel’’ (33 CFR 151.1510(a)(2)). For 

vessels subject to the requirements of 33 

CFR subpart D, we have clarified 33 

CFR 151.2025(a) to require only those 

vessels discharging ballast water into 

the waters of the United States to 

employ one of the required ballast water 

management methods. The suggestions 

pertaining to ballast water purchased 

from commercial or municipal sources 

have also been incorporated into 33 CFR 

151.1510(a)(4) and 151.2025(a)(2), by 

allowing for the use of water meeting 

Safe Drinking Water Act requirements 

as an alternative to requiring installation 

of a BWMS. 

One commenter questioned whether 

revisions made to the proposed phasetwo standard, after the practicability 

review from proposed 33 CFR 

151.1511(c), would include an 

opportunity for public comment. While 

neither those revisions nor the phasetwo standard are included in this final 

rule, we had always anticipated that any 

changes to an effective rulemaking 

would be subject to the notice and 

comment provisions of the APA unless 

the change fell within one of the narrow 

exemptions included within the APA. 

See 5 U.S.C. 553(b). Likewise, any 

changes made to this rule, including 

reinsertion of a phase-two standard, will 

need to comply with the APA. 

One commenter argued that proposed 

33 CFR 151.2045(b)(1) contained a cross 

reference to a section (33 CFR 151.1514) 

that does not exist. We believe the 

commenter was confused; 33 CFR 

151.1514 does exist in the CFR, but we 

did not propose any amendments to that 

section, therefore it did not appear in 

the NPRM. We have not made any 

revisions in response to this comment. 

One commenter argued that penalty 

provisions were too low. The penalty 

provisions included in proposed 33 CFR 

151.2080 have been adjusted for 

inflation per the civil penalty 

adjustment table in 33 CFR 27.3. See 

75 FR 36278 (June 25, 2010). Our 

statutory authority sets the maximum 

penalty that we may levy, with the 

allowance that penalties may be 

readjusted for inflation. 

Two commenters urged that the Coast 

Guard assign accountability for BWDS 

compliance to the vessel owner of 

record, instead of to ‘‘the owner, 

operator, agent, or person in charge,’’ as 

we proposed. We disagree with this 

suggestion. Persons at every level of 

authority, whether owner, lessee, or 

operator, may be held responsible for 

the failure of a vessel to follow the 

BWM practices required by this 

regulation, including use of an approved 

BWMS. 

One commenter agreed with our 

proposal to keep ballast water 

regulations for the Great Lakes separate 

from ballast water regulations for waters 

of the United States in general, citing 

the distinction also found in NISA. This 

final rule carries that distinction 

forward. 

One commenter noted that we define 

the term ‘‘build date’’ in proposed 

33 CFR 151.2005, but never use the 

term. Instead, proposed 33 CFR 

151.2035 used the term ‘‘vessel’s 

construction date.’’ The commenter 

recommended that we use the latter, 

and add a definition for it to replace the 

one for ‘‘build date.’’ Other commenters 

recommended that we use the same 

definition for ‘‘build date’’ as the IMO 

used for ‘‘constructed’’ in the IMO BWM 

Convention. 

We agree that the term used in the 

regulation should be the same as that 

defined. We have revised 33 CFR 

151.2005 to define the term 

‘‘constructed,’’ and have revised the 

tables in 33 CFR 151.1512 and 151.2035 

to use this term. We chose the term 

‘‘constructed,’’ as suggested by the 

second commenter, because this is the 

term used in the IMO BWM Convention. 

Thus, we have also revised the actual 

definition for ‘‘constructed’’ to mirror 

the definition from the IMO BWM 

Convention. This change in terminology 

does not reflect a substantive change 

from the NPRM. 

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One commenter requested that we 

remove the word ‘‘foreign’’ from 

proposed 33 CFR 151.2020, which 

provides an exemption for vessels in 

‘‘innocent passage.’’ They argued that it 

is possible, if rare, for a U.S. vessel to 

operate in waters of the United States on 

a route where it does not call on a U.S. 

port. The Coast Guard disagrees that the 

‘‘innocent passage’’ exclusion should 

apply to U.S. vessels, as this concept 

concerns foreign-flagged vessels 

operating in a coastal state’s territorial 

sea, and therefore has retained the 

‘‘foreign’’ vessel distinction in 33 CFR 

151.2020. 

One commenter asked for an 

explanation of proposed 33 CFR 

151.1505 and 151.2013 (Severability). 

These provisions are included in order 

to protect as much of the regulations as 

possible, in the event that their 

promulgation is subjected to a legal 

challenge. In short, they direct a 

reviewing court, upon a determination 

that portions of the regulations are 

invalid, to invalidate only those 

portions and leave the remaining 

provisions intact. 

One commenter requested we add a 

reference to 33 CFR 151.2015 

(Exemptions) in 33 CFR 151.2010 

(Applicability). The Coast Guard agrees 

with this suggestion and has made the 

requested edit. 

One commenter requested that we 

add a reference in 33 CFR 151.2015(b) 

(Exemptions) to the statutory exemption 

for crude oil tankers found at 16 U.S.C. 

4711(c)(3)(L). The Coast Guard has not 

made this change; the authority citation 

for 33 CFR part 151 subpart D already 

lists 16 U.S.C. 4711, therefore, adding a 

specific citation into the regulatory 

section would be redundant. 

One commenter requested that we 

amend the NPRM preamble to add a 

discussion of additional provisions of 

NANPCA and NISA exempting crude oil 

tankers in the coastwise trade from 

complying with BWM, specifically 

citing provisions regarding the 

statutorily required ‘‘Crude oil Tanker 

Ballast Facility Study’’ (16 U.S.C. 

4711(k)(3)). The commenter also 

requested that a discussion of the 

referenced study be added to the 

preamble of the NPRM. 

The Coast Guard has added the 

referenced report to the docket for this 

rule, as the commenter noted their 

inability to locate it. However, the Coast 

Guard disagrees with including a 

discussion of the study in the preamble 

to this final rule, as the report is not 

pertinent to the BWDS. To address the 

commenter’s recommendation to 

remove the exemption for crude oil 

tankers in the coastwise trade from the 

regulation, the Coast Guard notes that 

NISA’s statutory exemption precludes 

such action at this time (16 U.S.C. 

4711(c)(3)(L)). The Coast Guard notes, 

however, that the statutory exemption 

for crude oil tankers engaged in 

Coastwise trade found in NISA is not 

found in the CWA; therefore, these 

vessels must comply with all CWA 

requirements. 

One commenter requested that we 

include the specific zone demarcations 

in our definition of COTP. The Coast 

Guard has not made the requested 

change; the definition points to 33 CFR 

part 3, which already contains the 

specific delineations requested by the 

commenter. 

One commenter questioned the 

exemption for warships, naval 

auxiliaries, or other government vessels 

found in proposed 33 CFR 151.2015(a) 

and requested more information as to 

why that exemption was added. 

Our regulation is designed to be 

consistent with international law and 

practice, and international agreements 

relating to the protection and 

preservation of the marine environment 

routinely state expressly that they do 

not apply to any warship, naval 

auxiliary, or other vessels owned or 

operated by a nation and used, for the 

time being, only on government noncommercial service. However, this does 

not exonerate such vessels from 

implementing environmentally sound 

practices. Under such agreements, 

nations generally must ensure that such 

vessels act in a manner consistent, so far 

as reasonable and practicable, with the 

provisions of the agreements. 

One commenter requested that we 

specifically note that the Snell and 

Eisenhower Locks fall within the 

definition of ‘‘ports or places in the 

United States.’’ Another commenter 

requested the addition of a definition of 

the phrase ‘‘port or place of the United 

States.’’ The Coast Guard has not made 

these changes; the current definitions 

for ‘‘port or place of destination,’’ 

‘‘United States,’’ and ‘‘waters of the 

United States,’’ when read together, 

provide a definition for the phrase ‘‘port 

or place of the United States,’’ which 

would include the specified Locks. 

Adding a specific reference to only 

these two Locks into the regulation 

would inevitably lead to questions as to 

whether other Locks, waterways, or 

other places were also meant to be 

included in the regulation, adding 

unnecessary ambiguity. 

One commenter pointed out that the 

headers in the tables in 33 CFR 

151.1512 were improperly aligned with 

the information presented in the table. 

The Coast Guard has corrected this 

problem in this final rule. 

One commenter requested we either 

add definitions for the following terms 

or change the terms used to clarify their 

meaning. The terms (and locations in 

the proposed regulation) were: 

‘‘discharge port’’ (as used in 33 CFR 

151.1516), ‘‘crew’’ (as used in 33 CFR 

151.2050), and ‘‘jurisdiction of the 

United States’’ (as used in 33 CFR 

151.2070). 

The Coast Guard agrees, in part. These 

terms are used but not defined in the 

referenced sections; however, they are 

terms that have existed in regulation for 

many years. The Coast Guard has not 

received any indication that the use of 

these terms is confusing to the regulated 

industry or public in general. In light of 

this fact, we are not adding the 

requested definitions. 

Other Legal Issues 

One commenter requested 

consultation with the Prince William 

Sound Regional Citizens’ Advisory 

Council (PWS RCAC), citing the Oil 

Pollution Act of 1990 (OPA) 

requirement to do so. However, the 

applicable portion of OPA reads ‘‘[E]ach 

Federal department, agency, or other 

instrumentality shall, with respect to all 

permits, site-specific regulations, and 

other matters governing the activities of 

and actions of the terminal facilities 

which affect or may affect the vicinity 

of the terminal facilities, consult with 

the [PWS RCAC] prior to taking 

substantive action.’’ OPA sec. 5002(g). 

This final rule is not site-specific, nor is 

it governing activities of a terminal 

facility. It is regulating vessel activity. 

As such, the OPA consultation 

requirement does not apply to this rule. 

One commenter noted that the Great 

Lakes States have repeatedly urged 

Congress to pass comprehensive 

legislation to prevent the introduction 

and spread of NIS from all sources. This 

is beyond the scope of this rule, as it 

concerns a request for legislative relief 

and is not a comment on the NPRM. 

One commenter requested that the 

NPRM be revised to remove what the 

commenter called a ‘‘presumption’’ in 

the proposed practicability review 

which the commenter felt favored delay 

of the phase-two compliance date. As 

we have noted in this preamble, we 

have removed the phase-two standard, 

as well as its compliance dates, from 

this final rule (see V.A. Summary of 

Changes from the NPRM). We will keep 

the commenter’s concern in mind as we 

work to issue a subsequent rule that 

addresses a phase-two standard, as that 

rulemaking would most likely include a 

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recurring practicability review 

provision. 

One commenter stated that the 

applicability of the rule is confusing and 

needs to be specifically defined and 

consistent. As noted in preamble section 

V.A. Summary of Changes from the 

NPRM, the applicability of the final rule 

has changed from what was included in 

the NPRM. We have carefully 

constructed the applicability section in 

order to make it less confusing. 

One commenter urged that the 

implementation of the proposed rule be 

delayed in order to allow time for 

further research, which could then be 

used to encourage the development of 

one uniform, nationwide BWDS. The 

Coast Guard fully supports all research 

efforts into the subject of BWM and 

treatment; however, it would not be 

prudent to delay implementation of the 

phase-one standard at this time. As 

noted earlier in this section, the 

legislative authority for this rule does 

not allow the Coast Guard to preempt 

State actions to implement a more 

stringent BWDS. 

Additional BWM Requirements 

Nine commenters asked that the 

regulations be more specific in how 

other vessel-related vectors for invasive 

NIS movements (anchors, anchor 

chains, hulls) would be managed and 

enforced. 

The Coast Guard agrees that 

protecting the environment from 

invasive NIS requires addressing these 

other vessel-related vectors and will 

continue to explore how to accomplish 

this. Aside from clarifying where 

cleaning of ballast tanks should take 

place, the final rule continues the 

applicable requirements from 33 CFR 

151.2035 and moves them to 33 CFR 

151.2050. The Coast Guard is acting 

under the legislative mandate in 

NANPCA, as amended by NISA to direct 

vessels to carry out management 

practices necessary to reduce the 

probability of unintentional discharges 

resulting from ship operations other 

than ballast water discharge. 16 U.S.C. 

4711(c)(2)(E). 

One commenter urged the Coast 

Guard to expand the language in 33 CFR 

151.2050 to specifically address 

ballasting activities that could affect 

units of the National Park Service. 

The Coast Guard believes the existing 

regulatory language appropriately 

captures the units of the National Park 

Service. 

6. Regulatory Assessment (RA) and 

Initial Regulatory Flexibility Act (IRFA) 

Affected Population 

Two commenters noted that the 

NPRM RA addressed only the impact on 

U.S.-flagged vessels. One of these 

commenters stated that it is illogical and 

incorrect to ignore the costs that this 

rule would impose on foreign-flagged 

vessels calling at U.S. ports. 

The Coast Guard estimated cost 

impacts for foreign-flagged vessels in 

the NPRM RA (see Appendix C) and the 

final rule RA (see Appendix D). As 

previously discussed, we have also 

made the phase-one standard as 

consistent as possible with the IMO 

BWM Convention’s discharge standard. 

We assume foreign governments that 

become a party to the IMO BWM 

Convention and the foreign-flagged 

vessels they administer to be 

responsible for the implementation and 

compliance with the IMO BWM 

Convention once it comes into force. We 

assume these foreign government 

administrations and the foreign-flagged 

vessels they administer to be 

responsible for the costs associated with 

the implementation and compliance of 

the IMO BWM Convention. 

Therefore, in the analyses of the 

NPRM and this final rule, our primary 

cost estimate of the phase-one standard 

rule includes costs to U.S. flaggedvessels only. Historically, Coast Guard’s 

assessment of impacts from regulations 

related to international conventions 

have taken into account the costs 

incurred by U.S. vessels and owners and 

operators only (e.g., regulations related 

to The Standards of Training, 

Certification & Watchkeeping 

Convention (STCW) and regulations 

related to the International Convention 

for the Prevention of Pollution From 

Ships (MARPOL)). 

The Coast Guard received a total of 98 

comments related to inland, Great 

Lakes, and coastwise industries. The 

breakdown of the comments was 35 

comments related to the Great Lakes and 

63 related to inland and coastwise 

vessels. The inland and coastwise 

industry comments mentioned the 

following vessel types: towing vessels, 

barges, and offshore supply vessels. The 

commenters raised many different 

issues related to the ballast water 

operations from these industries, such 

as the use of municipal/potable water, 

technology cost and its potential impact 

on the industry, size limitations, and 

benefits. The majority of the comments 

were related to the underestimation of 

the affected population in the NPRM 

RA, which did not account for inland 

vessels, and issues pertaining to the 

Great Lakes vessels and operations. 

Given the issues raised by these and 

other commenters, the Coast Guard has 

revised the applicability of the BWDS 

rule. The Coast Guard is publishing this 

final rule to apply the phase-one BWDS 

only to the following vessels intending 

to discharge ballast water into waters of 

the United States: vessels entering 

waters of the United States from outside 

the EEZ, and those seagoing vessels that 

operate in waters of the United States in 

more than one COTP Zone and are 

greater than 1,600 GRT (3,000 GT (ITC)). 

The Coast Guard is conducting 

additional feasibility analysis needed 

before expanding the applicability in 

this final rule. 

Additionally as noted above, the 

Coast Guard has decided at this time to 

exempt vessels that operate solely in 

inland waters from the phase-one 

BWDS. The Coast Guard fully intends to 

expand the BWDS rule to such vessels, 

as noted in the final rule preamble 

section V.A. Summary of Changes from 

the NPRM, but has determined that 

additional analysis is necessary to 

support this expansion. We also intend 

to conduct additional research as 

necessary. 

Regarding the comments about 

underestimation of affected population, 

the Coast Guard acknowledges that 

some inland vessels, towing vessels, and 

crew boats were not included in the 

NPRM RA due to their lack of ballasting 

operations or non-traditional ballast 

water operations. Detailed justification 

for not including these vessels is 

presented on chapter 2, page 37 of the 

NPRM RA (available in the docket). 

Phase-Two Standard 

Four commenters expressed concern 

that the cost estimates for the proposed 

phase-two standard were not included 

in any of the supporting documentation 

or analysis. 

One commenter argued that skipping 

phase-one in favor of adopting phasetwo is unrealistic for many reasons, 

including: (a) An onerous cost of 

research and development would result 

to the technology industry, which has 

already borne the expense of 

development to the international 

standards with no appreciable return on 

investment due to the slow pace of 

implementation; and (b) the maritime 

industry would be asked to invest, at a 

higher cost, in technology that does not 

have a validated environmental benefit 

over that resulting from use of systems 

compliant with other standards. 

The Coast Guard acknowledges the 

comments which stated that the 

analyses included in the NPRM did not 

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address the phase-two standard 

specifically. The Coast Guard has 

determined that additional analysis is 

needed, and has already begun 

development of these analyses. The 

Coast Guard has decided to move 

forward with the phase-one standard 

with the publication of this final rule 

that does not include the phase-two 

standard. The Coast Guard will work on 

developing the economic and 

environmental analyses to support the 

evaluation of the phase-two standard. 

Phase-One Cost 

Five commenters provided statements 

on the costs of BWMS. One commenter 

provided cost information for 

purchasing BWMS ranging between 

$400,000 and $580,000. Based on this 

information, this commenter argued that 

the installation BWMS costs presented 

in the NPRM are very optimistic. 

Another commenter provided costs 

comparisons with the 2009 CSLC 

Report, ‘‘Assessment of Efficacy, 

Availability and Environmental Impacts 

of Ballast Water Treatment Systems for 

Use in California Waters,’’ and a study 

from the Danish Shipowners’ 

Association (DSA) from June 2009. The 

commenter noted that the reports 

present the following acquisition costs 

ranges: from $150,000 to $2,300,000 and 

$640,000 to $1,670,000 per system, from 

the CSLC and the DSA reports, 

respectively. This commenter also 

argued that cost to industry could be 

higher for the phase-two standard, 

depending on the practicability review. 

One commenter also cited the 2009 

CSLC report presenting estimates of 

BWMS of 1 to 2 percent of the total cost 

of a vessel. 

Another commenter provided 

acquisition and installation costs for 

systems currently being tested from 

$250,000 to over $2,000,000, depending 

on the methods used to treat the ballast 

water. This commenter argued that, 

although a number of vendors have 

provided cost estimates to potential 

customers, these estimates are not based 

on actual shipboard installations and 

consequently do not reflect real world 

issues. This commenter also argued that 

costs associated with systems which 

could meet the more stringent standards 

are expected to be significantly higher. 

Another commenter argued that there 

are insufficient data available related to 

the actual operation/maintenance costs 

for use of any system due to the fact that 

many systems are yet only at the stage 

of testing to determine efficacy. This 

commenter also stated that anticipated 

acquisition and installation costs for 

systems designed to meet the more 

stringent phase-two standard are 

expected to be considerably higher than 

for the currently available systems. 

The Coast Guard acknowledges these 

comments and has incorporated 

additional data provided by the 

commenters in the cost analysis of the 

final rule RA. The Coast Guard notes 

that these additional data are within the 

range of estimates presented in the 

NPRM RA available on the docket. In 

the NPRM RA, chapter 3 (table 3.4) 

presents costs for installation of the 

BWMS ranging from $250,000 to 

approximately $2,500,000, depending 

on the type of the system and the ballast 

water pumping capacity. Commenters 

provided estimates ranging from 

$250,000 to $2,300,000. Thus, the Coast 

Guard disagrees with the comment that 

the costs in the NPRM are very 

optimistic, as the cost ranges provided 

by the commenters are within the range 

of the Coast Guard estimates. 

Because this type of specialized 

equipment cannot be independently 

priced, the cost estimated in the NPRM 

relied largely on manufacturer-provided 

data. Manufacturers supplied data for 

acquisition, installation, operation, and 

maintenance costs of BWMS. The Coast 

Guard’s cost estimates are based on the 

best data available at the time of the 

analysis. The Coast Guard’s estimates 

are consistent with other notable cost 

estimates such as those made by Lloyds’ 

Register ($145,000 to $2,000,000) and 

the Congressional Budget Office 

($300,000 to $1,000,000). 

The Coast Guard is continuously 

monitoring BWMS technologies for new 

developments and changes in costs. 

Contrary to the assertion made by a 

commenter, the Coast Guard has not 

estimated the BWMS costs based on 

vessel values. The Coast Guard 

acknowledges the comment that 

achieving higher standards might 

represent higher BWMS cost. The Coast 

Guard is working with the industry to 

identify the potential costs of more 

stringent standards. 

One commenter argued that the 

installation costs for phase-one 

approved systems were underestimated 

in the NPRM RA by three to four times 

due to the fact that the cost estimates for 

BWMS uses the smallest system size 

(system flow) as an average system size. 

The commenter also provided data 

based on Shipbuilding Market Forecast. 

According to the commenter, the data 

show that the average system size 

processes between 1,200 m3 and 1,500 

m3 of water per hour, depending on 

assumptions regarding relation between 

dead weight tonnage, total ballast water 

capacity, and flow. The commenter 

argued that the cost for such a system 

could easily be $600,000–$700,000, to 

which an installation cost of another 25 

to 75 percent has to be added depending 

on whether the vessel is a new build or 

retrofitted. 

The Coast Guard disagrees with the 

argument that the cost estimates for 

BWMS in the NPRM RA were based on 

the smallest BWMS cost. The Coast 

Guard developed low and high 

installation cost estimates for BWMS to 

various vessel types and ballast water 

capacities. The Coast Guard estimated 

the BWMS installation costs based on 

the average costs for each available 

BWMS. The low costs are related to the 

least expensive treatment available for 

different types of vessel with different 

ballast water pump capacities. The 

Coast Guard recognizes that not all 

systems are appropriate for all vessel 

types. Chapters 3 and 4 of the NPRM 

RA, available on the docket, present a 

detailed description on costs estimates. 

Benefits 

One commenter proposed that the 

Coast Guard should represent the 

invasive species’ environmental harm in 

addition to economic harm estimates 

presented in table 8 of the NPRM. 

Table 8 of the NPRM presents 

estimates of the number of NIS that may 

cause severe economic damages. The 

derivation of these estimates is more 

fully detailed in chapter 5, section 5.5 

of the NPRM RA available on the 

docket. The purpose of chapter 5 of the 

NPRM RA is to estimate the value of the 

economic harm caused by NIS in order 

to estimate monetary benefits from the 

proposed rule to compare against cost 

estimates. Chapter 5 presents the total 

number of NIS invasions due to ballast 

water in table 5.6, which includes all 

invasions that cause environmental 

harm, economic harm or cause no harm. 

The Coast Guard then limits the further 

analysis of benefits to those invasions 

that cause economic damage that can be 

expressed in monetary terms. The Coast 

Guard believes that this approach was 

appropriate for use in the NPRM RA. 

The Coast Guard recognizes that some 

NIS invasions may cause environmental 

harm that cannot be easily monetized. 

The Final Programmatic EIS (FPEIS), 

available in the docket for this rule, 

further describes the potential 

environmental harm of invasive NIS. 

One commenter suggested that the 

costs associated with introduced 

invasive NIS considered during 

practicability reviews should not be 

limited to a 10-year time frame but 

should, instead, be considered 

permanent costs, since NIS 

introductions are difficult to fully 

eradicate and long-term control or 

containment is often necessary. The 

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commenter argued that projected costs 

would likely outweigh the costs of 

technology development, installation, 

and maintenance over the long run. 

The Coast Guard recognizes that the 

rule will continue to accrue benefits 

beyond the time-frame of the NPRM RA. 

The Coast Guard has added analysis of 

additional timeframes to the final rule 

RA representing potential benefits of the 

rule beyond the 10-year period. 

One commenter asked what the 

additional avoided environmental and 

social damages and economic benefits of 

a BWDS would be at more stringent 

standards. 

The Coast Guard included the 

evaluation of potential benefits from 

standards that are more stringent than 

the phase-one standard in the NPRM 

RA, section 5.7 (available on the 

docket). The benefits evaluation was 

based on the mathematical model 

developed for the DPEIS, which 

estimated the reduction in the mean rate 

of successful introductions of various 

alternatives standards. The mid-range of 

benefits for more stringent standards 

varies from $286 million to $447 

million. 

One commenter argued that ‘‘while 

the initial costs to implement the 

proposed standard would likely be 

several million dollars annually for the 

first five years, subsequent costs would 

be significantly lower, likely by an order 

of magnitude. Vessel owners can 

generally choose whether/how to spread 

out such costs over time, since 

installation costs are usually capital 

costs that can be amortized over several 

years. The actual cost for an individual 

vessel to install and maintain 

appropriate technology would vary 

depending on vessel type and size. 

Therefore, a cost benefit comparison 

reveals the potential for a significant 

economic benefit resulting from the 

relatively small investment by vessel 

owners.’’ 

The Coast Guard agrees that there are 

potential significant economic and 

environmental benefits from this final 

rule. 

Regulatory Flexibility Analysis 

One commenter noted that the Coast 

Guard did not take into account the 

cumulative impact of other Coast Guard 

regulations on small businesses. The 

commenter argued that the BWDS rule 

will impose more costs on top of the 

other regulations for affected passenger 

vessel operations. 

For the proposed rule, the Coast 

Guard completed an Initial Regulatory 

Flexibility Analysis (IRFA). The specific 

statutory requirements of an IRFA can 

be found at 5 U.S.C. 603(b). Under these 

statutory requirements, we did not 

consider the cumulative impact of other 

Coast Guard regulations on small 

businesses or affected passenger vessel 

operations. The Coast Guard 

acknowledges that other Coast Guard 

regulations have imposed additional 

costs on vessel owners and operators 

subject to this rule, which contains 

revised applicability that excludes most 

vessels operating solely in coastwise 

trade as previously discussed. 

Many of these published regulations 

implement international agreements 

such as the International Convention for 

the Prevention of Pollution from Ships 

(MARPOL) and the International 

Convention for the Safety of Life at Sea 

(SOLAS). The United States is obligated 

to implement and comply with these 

international agreements to which the 

United States is a party, and to do so, 

under U.S. law the Coast Guard usually 

must promulgate regulations that are 

consistent with these agreements. If U.S. 

vessels on foreign voyages are not in 

compliance with applicable 

international law, it could reduce their 

ability to engage in commerce and trade. 

This rule generally aligns with the 

standards adopted in the International 

Convention for the Control and 

Management of Ships Ballast Water and 

Sediments, 2004 (IMO BWM 

Convention), which has not entered into 

force at this time and which seeks to 

establish global minimum ballast water 

discharge standards. 

Additionally, for this rule, the Coast 

Guard is acting under the legislative 

mandates in NANPCA, as amended by 

NISA, to authorize the use of any 

alternative methods of BWM that are 

used in lieu of mid-ocean BWE. As 

previously discussed, these mandates 

require the Secretary of Homeland 

Security to ensure to the maximum 

extent practicable that aquatic nuisance 

species are not discharged into waters of 

the United States from vessels. 16 U.S.C. 

4711(c)(2)(A). In addition, NISA 

requires the Secretary to assess and 

revise the Department’s BWM 

regulations not less than every 3 years 

based on the best scientific information 

available to her at the time of that 

review, and potentially to the exclusion 

of some of the BWM methods listed at 

16 U.S.C. 4711(c)(2)(D). 16 U.S.C. 

4711(e). The Coast Guard is publishing 

this final rule based on these mandates. 

Two commenters argued that, as a 

part of the financial burden, it is 

important for vessel companies to note 

the amount of employees/mariners they 

have. 

The Coast Guard agrees with the 

commenters and would like to note that 

the number of employees is taken into 

consideration in the IRFA. The IRFA is 

in chapter 7 of the NPRM RA available 

on the docket. The IRFA’s goal is to 

assess the proposed rule’s impact on 

small entities. Company revenue and 

number of employees (as well as 

number of vessels) are variables used in 

the estimation of potential economic 

impacts to small businesses. 

Small Business Administration (SBA)— 

Office of Advocacy 

The Coast Guard received comments 

from the SBA Office of Advocacy 

regarding the impact that the proposed 

rule would have on small entities. The 

comments provided by the SBA focused 

on small businesses within the tugboat, 

towing vessel, and supply barge 

industries. According to the SBA letter, 

these small businesses are concerned 

that the Coast Guard’s economic 

analysis does not account for a 

significant number of vessels operated 

by small businesses. These businesses 

also contend that installing the required 

BWMS will not be economically feasible 

for the large number of vessels that 

discharge relatively small amounts of 

ballast water. The SBA also expressed 

concern about the cumulative effect of 

the proposed regulations should the 

phase-two standard be implemented 

without a longer grandfather period 

than the 5-year period proposed. 

The SBA made the following 

suggestions to improve the Coast Guard 

small entities analysis: 

(a) Expand the scope of regulatory 

flexibility analysis to include more 

vessels (vessels less than 100 feet in 

length, tugboats, towing and supply 

vessels). 

(b) Consider additional regulatory 

alternatives to increase flexibility for 

small business (such as exemption for 

vessels with relatively low-volume 

ballast tanks). 

(c) Include a grandfather provision in 

the phase-two standard. 

The Coast Guard acknowledges the 

SBA concerns related to the vessels 

mentioned previously and is studying 

the BWM options for small vessels and 

vessels less than 1,600 GT that operate 

solely in coastwise trade and inland 

waters of the United States. The Coast 

Guard has received numerous 

comments from these industries and has 

revised the applicability of the rule. As 

noted earlier in this preamble, the 

BWDS in this final rule applies only to 

vessels entering waters of the United 

States from outside the EEZ, to 

coastwise vessels that are more than 

1,600 GT, and to certain other seagoing 

vessels meeting specific size thresholds 

(see V.A. Summary of Changes from the 

NPRM). The Coast Guard fully intends 

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to expand the BWDS rule to all vessels, 

as proposed in the NPRM, but has 

determined that additional analysis is 

necessary to support this expansion and 

to consider issues related to 

grandfathering for the phase-two 

standard. We also intend to conduct 

additional research as necessary. 

Other 

One commenter stated that our use of 

certain terms such as ‘‘uncertain’’ and 

‘‘potential’’ does not ‘‘inspire 

confidence in your justification for the 

broad scope of the proposed rule.’’ 

The Coast Guard notes that within the 

regulatory assessment process, the 

presence of uncertainty is common as 

information and data are sometimes 

only partially available or not available 

at all due to a variety of factors, such as 

the stages of technologies in research 

and development. The language used in 

the NPRM RA correctly reflects the 

uncertainty inherent in the state of 

available information and technology. 

The Coast Guard is monitoring the 

development of technology and 

analyzing papers on aquatic NIS for 

additional data. 

Economic Comments Raised in the 

Context of the DPEIS 

The Coast Guard received several 

comments on the BWDS DPEIS that 

concerned issues related to economics. 

One commenter stated that the range 

of quantified benefits and annual costs 

needs to be presented for alternatives 3 

to 5 to allow comparison among the 

alternatives. Another commenter asked 

if the benefits of ballast water treatment 

were only evaluated for alternative 2 

and further adds that there are few 

details provided on these cost-benefit 

numbers and methods. One commenter 

stated that further discussion and 

analysis of costs vs. benefits, addressing 

all of the alternatives considered, would 

be useful. 

In the NPRM RA (available on the 

docket), chapter 5 (table 5.12), the Coast 

Guard presents the total potential 

benefit from different proposed 

alternatives. The values presented in 

this table enable the comparison of the 

benefits of alternatives 2, 3, and 4. Data 

to support the analysis of alternative 5 

is not yet available. In addition, the 

Coast Guard is further investigating 

costs and benefits of more stringent 

standards. 

One commenter inquired as to what 

are the additional avoided 

environmental and social damages and 

economic benefits of BWDSs at more 

stringent standards and asked that the 

Coast Guard provide quantitative data 

and sources for all information. The 

commenter suggested that a study be 

done on the environmental benefits of 

marine transportation, especially in 

terms of higher energy efficiency. The 

requested study on the benefits of 

marine transportation is beyond the 

scope of this rule. 

7. DPEIS 

Adequacy of Document 

One commenter stated that the DPEIS 

does not provide scientific data to show 

that alternatives 2 through 4 will ensure 

that the residual NIS population will 

not survive, persist, spread, or 

proliferate in the receiving waters. The 

Coast Guard agrees with this 

assessment, but notes that our 

scientifically-based analytical approach 

is not intended to show that any of these 

alternatives will specifically ensure that 

the residual NIS population will not 

survive, persist, spread, or proliferate, 

but rather to evaluate the probabilities 

of decreased introductions and 

spreading of NIS among the different 

alternatives. The NRC report ‘‘Assessing 

the Relationship Between Propagule 

Pressure and Invasion Risk in Ballast 

Water’’ states that ‘‘The available 

methods for determining a numeric 

discharge standard for ballast water are 

limited by a profound lack of data and 

information to develop and validate 

models of risk-release relationship. 

Therefore, it was not possible with any 

certainty to determine the risk of 

nonindigenous species establishment 

under existing discharge limits [* * *]’’ 

Chapter 4 of the NRC report discusses 

in detail the risk-release relationship 

and a wide range of models related to 

invasion risk as a function of the 

probability of a species establishment. 

The NRC recommendations included: 

‘‘In short-term, mechanistic singlespecies models are recommended to 

examine risk-release relationships for 

best case (for invasion)-scenario 

species.’’ 

One commenter stated that the DPEIS 

alternatives rely on indicator 

microorganisms to prevent bacterial 

invasion, yet the selection of Vibrio 

cholera, E. coli, and Enterococci for this 

purpose is not well supported and the 

presence or abundance of these bacteria 

does not verify the composition or 

abundance of other potential invasive 

microbes in the ballast water. 

The Coast Guard disagrees with this 

comment. We developed the DPEIS 

alternatives through a rigorous process 

including three separate expert panel 

workshops, public scoping meetings, 

and cooperating agency participation. 

The presence or abundance of the 

selected indicator organisms is not 

intended to verify the composition or 

abundance of other potential invasive 

microbes in the ballast water but, rather, 

their purpose is to indicate their 

presence. 

One commenter stated that the DPEIS 

requires further refinement at all levels 

because some information is out-of-date, 

that many of the existing data are not 

properly cited, and that there are issues 

with grammar, punctuation, and clarity. 

The Coast Guard disagrees with this 

comment. The DPEIS was reviewed by 

scientific experts and cooperating 

agencies, and is sufficiently current to 

describe the affected environment and 

evaluate the impacts of the discharge 

standard alternatives. In order to ensure 

future environmental analysis 

documents are of the highest quality, 

the Coast Guard made typographical 

changes in the Final PEIS (FPEIS), as 

appropriate. 

One commenter requested that the 

phase-one and phase-two standards 

listed in the proposed rule should 

clearly refer back to the alternatives 

analyzed in the DPEIS. The Coast Guard 

identified alternative 2 of the DPEIS as 

its preferred alternative, and this is now 

the phase-one standard. The phase-two 

standard was removed from the final 

rule and will be part of a supplemental 

environmental analysis, which will be 

issued either with a notice or other 

rulemaking document. 

One commenter suggested changing 

DPEIS page breaks so table and figures 

are not broken up, and not confusing the 

labeling between tables and figures. The 

Coast Guard agrees that this can make 

comprehension of a document difficult, 

and made changes in the FPEIS, as 

appropriate. 

One commenter suggested defining 

the term ‘‘microorganism,’’ updating the 

IMO BWM Convention status and data 

on States’ expenditures for bioinvasion 

mitigation and NIS management, adding 

a cited reference to Literature Cited, 

correcting other cites, and providing 

additional references. The Coast Guard 

reviewed the indicated DPEIS sections 

and made changes in the FPEIS, as 

appropriate. 

One commenter stated that a sentence 

in a discussion of the crab Hemigrapsus 

sanguineus in the DPEIS was incorrectly 

attributed to the United States 

Geological Survey and gave an alternate 

citation. The Coast Guard verified the 

citation in the DPEIS is correct and the 

Coast Guard was not able to readily 

locate the relevant information in the 

alternate citation provided by the 

commenter. 

One commenter stated that the DPEIS 

fails to make the case for applying 

requirements that may be appropriate 

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17288 Federal Register / Vol. 77, No. 57 / Friday, March 23, 2012 / Rules and Regulations 

for oceangoing vessels to Great Lakes 

vessels. As we have discussed in this 

preamble, the Coast Guard has the 

authority to regulate Great Lakes vessels 

in this way, and is charged with 

minimizing introduction and spread of 

NIS in waters of the United States to the 

maximum extent practicable (see V.B.5 

Discussion of Comments: Legal). We 

note, however, that this final rule does 

not require Great Lakes vessels to 

comply with the BWDS at this time, and 

we must take into consideration the 

factors identified in 16 U.S.C. 

4711(c)(2)(H). We will keep this 

comment in mind in our evaluation of 

the practicability of expanding the 

BWDS applicability to all vessels 

discharging ballast water in waters of 

the U.S. 

One commenter stated concern that 

current Coast Guard staffing levels will 

not be adequate to enforce the criteria 

during land-based and shipboard 

reviews of independent certification 

facilities, or ILs, and that needs to be 

discussed in the FPEIS. Staffing 

decisions and needs of Federal agencies 

are beyond the scope of this rule. 

However, we note that the Coast Guard 

has been conducting oversight of ILs for 

several decades. 

The PWS RCAC requested that a copy 

of the Crude Oil Tanker Ballast Facility 

Study be included in the FPEIS for this 

rule and that the 1997 analysis for 

technology available for current onshore 

water treatment be updated to 2009 

data. PWS RCAC further stated that the 

proposed rule and DPEIS should be 

revised and reissued for a second public 

comment review to ensure that 

comments and concerns were accurately 

reflected and included to improve both 

products. 

The Coast Guard acknowledges this 

comment. The Crude Oil Tanker Ballast 

Facility Study is now available to the 

public in the docket for this rule. 

Finally, while we are not subjecting the 

NPRM and DPEIS to a second round of 

comments, we anticipate that we will 

open another comment period when 

addressing the phase-two standard and 

an expanded applicability. 

Adequacy of Standard 

One commenter stated that the FPEIS 

must provide a sound scientific basis to 

support alternative 2 thresholds as 

means for eliminating or substantially 

mitigating NIS invasion, not just simply 

selecting NIS reduction thresholds that 

are two or three orders of magnitude 

lower than what arrives in ballast water 

today. The commenter further stated 

that the DPEIS does not provide a sound 

scientific basis for its size distinction 

and that, empirically, the threat posed 

by NIS is not a function of organism 

size. 

The Coast Guard disagrees with this 

comment. The goal of a BWDS, as stated 

in the DPEIS, is reduction or prevention 

of NIS introductions and associated 

impacts. We developed the DPEIS 

alternatives through a rigorous process 

including three separate expert panel 

workshops, public scoping meetings, 

and cooperating agency participation. 

The Coast Guard based the resulting 

standards on an allowable concentration 

of organisms larger than a specified size 

criterion, providing a balance between 

protection and practicability and taking 

into account the expected capabilities of 

technology. The BWDS alternatives do 

not represent the minimum viable 

populations for all taxonomic groups. 

One commenter stated that the 

proposed E. coli and intestinal 

enterococci standards are not strong 

enough in that they are less stringent 

than the EPA’s criteria for recreational 

water contact. The Coast Guard 

acknowledges that the standards in the 

BWDS may appear to be less stringent 

than EPA standards for water quality. 

However, the water quality standards 

are for ambient conditions, not 

discharge standards. 

One commenter pointed out that the 

concept of indicator organisms as 

surrogates for pathogens has served the 

drinking water supply industry well 

since its establishment of presence/ 

absence testing that is now routinely 

used. The Coast Guard agrees with this 

comment, and notes that the DPEIS 

included indicator organisms in some of 

the alternatives. 

One commenter stated that, based on 

scientific reports from both the United 

States and Canada, the current BWM 

measures in place in the St. Lawrence 

Seaway and the Great Lakes (BWE and 

salt-water flushing for no ballast 

onboard vessels) protect the waters of 

the Great Lakes, making the proposed 

BWDS unnecessary. The commenter 

further stated that the proposed phaseone BWDS, according to available 

science, will ensure that aquatic NIS are 

not discharged into waters of the United 

States from vessels. The commenter 

added that the approach discussed in 

the NPRM that would bypass phase one 

and go directly to the phase-two 

standard is not practicable and it is 

doubtful that it would provide greater 

protection of the aquatic environment. 

The Coast Guard acknowledges that 

there have been no new reports of 

introductions of invasive NIS into the 

Great Lakes since implementation of the 

BWM measures mentioned by the 

commenter. While the lack of reports of 

new introductions into the Great Lakes 

is promising and there is a reason to be 

optimistic that current BWM methods 

are having an effect, there are 

continuing reasons to be concerned and 

not to accept these findings as 

definitive. For instance, the lack of 

comprehensive sampling may mean that 

some events have not been detected. 

Other possibilities are that there have 

been introductions, but that there have 

been lags in species establishment. Also, 

we note that the practicability review 

process referenced by the commenter 

was designed to ensure that any bypass 

of phase one to phase two would only 

occur if it could be practicably 

achieved. 

Consideration of Treatment Method 

Impacts 

Two commenters pointed out that the 

DPEIS does not address the impacts of 

specific BWMS. 

Another commenter said that the 

statement in the DPEIS that alternatives 

2 through 5 would not have additional 

adverse impacts on environmental and 

socioeconomic resources might not be 

an acceptable assumption for some 

treatment options (such as chemical 

disinfectants). 

Two commenters recommended that 

the Coast Guard explicitly consider the 

environmental impacts of approaches to 

meet BWDS. The first commenter 

focused on methods that could involve 

active substances at high concentrations 

that could be persistent, toxic, or both. 

The second commenter recommended 

that the Coast Guard assess treatment 

technologies in coordination with the 

EPA by conducting a FPEIS in 

conjunction with the practicability 

review and include the impacts of both 

biocide residuals and treatment 

byproducts, cumulative impacts 

(multiple discharging ships and 

multiple types of active substances), and 

to ensure that discharges are consistent 

with Clean Water Act requirements. 

One commenter stated that the DPEIS 

does not analyze the effects of potential 

technologies and methods for achieving 

BWDS, including chemical residuals, 

reaction by-products, thermal pollution, 

energy use, and dockside impacts, and 

that until those are evaluated, impacts 

on ESA listed species cannot be 

assessed. The commenter stated that the 

agency understands that the ‘‘action’’ is 

establishing standards, and continues to 

support the process for establishing the 

standards. 

The Coast Guard acknowledges these 

comments and clarifies that ballast 

water treatment systems were not 

included in the DPEIS. However 

Appendix F of the FPEIS does include 

an analysis of ballast water treatment 

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technologies in use by vessels enrolled 

or being reviewed by STEP as a means 

to show the practicability of the BWDS 

set forth in this rule. This information 

is not meant to be detailed or allinclusive. Methods to achieve the 

standard will be evaluated in separate 

environmental analyses as part of the 

approval process. All appropriate 

actions, resources, and impacts will be 

taken into account. 

One commenter inquired about a 

statement in the DPEIS under the 

description of chlorine as a biocide that 

impact to ships’ ballast tanks from the 

corrosion is a concern, asking whether 

it is a Coast Guard or a maritime 

industry concern, and why. The Coast 

Guard is concerned with any potential 

corrosion issues that could affect the 

safety or life of a vessel. Any BWMS 

that is going to require additional 

maintenance or shorten the life of the 

vessel has the potential to cause ripple 

effects through the maritime 

transportation system. 

One commenter stated that it is very 

difficult, given the current stage of 

scientific evidence and BWMS, to 

discuss the merits of more stringent 

standards than those imposed by IMO, 

especially as extreme an alternative as 

sterilization. The commenter further 

stated that sterilization of ballast water 

would task the maritime industry with 

an unwarranted standard and would 

probably be impossible to achieve. The 

Coast Guard agrees that the total 

sterilization of ballast water, specifically 

in regards to microbiological organisms, 

is challenging, if not impossible to 

achieve. The preferred alternative was 

developed taking into consideration 

environmental protection and 

practicability, including the economic 

and technical aspects of implementing 

BWDSs. 

One commenter stated that 

destruction of spore-like phases of 

marine life may be impracticable 

without actually distilling ballast water 

and, even so, any residue may well have 

to be treated as toxic waste. Another 

commenter stated that BWM will 

prevent organisms from reproducing 

and releasing larvae into the 

environment. 

The Coast Guard does not agree or 

disagree with these comments, as they 

relate to specific types of BWMS. As 

noted earlier, specific BWMS were not 

included in the DPEIS. These specific 

BWMS will be evaluated in separate 

environmental analysis as part of the 

approval process. All appropriate 

actions, resources, and impacts will be 

taken into account in that process. 

Two commenters stated that the 

foundation for setting any BWDS under 

NEPA is the ability to conduct a cost/ 

benefit assessment, but that it cannot be 

done because there is no way to predict 

or quantify the environmental benefit 

(measurement of invasions which did 

not occur) of the treatment alternatives. 

The commenter explained that a 

reasonable cost/efficacy ratio and 

measurable reduction of introduced 

organisms are needed, and without a 

reasonable, scientifically-based metric 

to show continual improvement, the 

perceived benefit may not meet 

measured benefit, leading to more 

stringent regulation and additional 

implementation costs. 

The Coast Guard disagrees with these 

comments. As we have discussed, 

specific BWMS were not included in the 

DPEIS, but the FPEIS does include an 

analysis of STEP vessels with ballast 

water treatment technologies as a means 

to show the practicability of the BWDS 

set forth in this rule. Methods to achieve 

the BWDS will be evaluated in separate 

environmental analyses during the 

approval process for each BWMS. 

Additionally, the Coast Guard did 

conduct a scientifically based analysis 

to predict the relative probability of NIS 

establishment for the discharge standard 

alternatives in the DPEIS. For purposes 

of complying with NEPA, the Council 

on Environmental Quality regulations 

state that weighing of the merits and 

drawbacks of the various alternatives 

need not be displayed in a monetary 

cost-benefit analysis and should not be 

when there are important qualitative 

considerations. 

DPEIS Modeling Comments 

One commenter stated that treating a 

lack of current science as meeting the 

‘‘best available science’’ requirement of 

NISA may be a practical necessity in 

order to adopt an environmentally 

protective and economically rational 

standard in the near future. The 

commenter did not think it is reasonable 

to assess in advance the biological 

effectiveness of this ‘‘first established 

standard,’’ as there would be no other 

numeric standard to compare to. The 

commenter also stated that the 

relationship between the frequency and 

magnitude of introductions and the 

probability of successful NIS 

establishment should be a priority for 

future research to establish a baseline 

for future adjustments to discharge 

standards. 

The Coast Guard disagrees with this 

comment. First, the statutory 

requirement from NANPCA, as 

amended by NISA, is that we use ‘‘best 

scientific information available,’’ not 

‘‘best available science.’’ Second, 

although the amount of scientific 

information available on aquatic NIS is 

not ideal, the Coast Guard conducted a 

scientifically-based analysis to predict 

the relative probability of NIS 

establishment for the BWDS alternatives 

in the DPEIS. New information on the 

probability of aquatic NIS establishment 

will be considered for future evaluation 

of discharge standards. 

Two commenters stated that the Coast 

Guard argues convincingly that 

population viability analysis (PVA) is 

the most suitable analytical 

methodology to use for the NEPA 

analysis, and that we should consider 

revisiting the approach if new 

information becomes available in 

intervening years. The Coast Guard 

agrees with the comment. New 

information on the probability of 

aquatic NIS establishment will be 

considered for future evaluation of 

discharge standards. 

One commenter asked whether there 

is precedent for using PVA for the type 

of NIS application that the DPEIS 

addresses. Another commenter 

expressed concern that the Coast Guard 

has not provided sufficient 

documentation to support the use of 

PVA ‘‘in a marine or aquatic situation 

with invertebrates and/or 

microorganisms.’’ 

As the Coast Guard noted in the 

DPEIS, the application of PVA to marine 

and aquatic invertebrates and 

microorganisms is novel. However, this 

does not affect the underlying scientific 

logic of this approach (e.g., Andersen 

2005). PVA has been applied to 

terrestrial invertebrates (e.g., Schultz 

and Hammond 2003). The diffusion 

model on which the PVA in the report 

is based has been applied to microbial 

populations (e.g., Ponciano et al 2005). 

One commenter stated that an 

evaluation of extinction probability 

needs to consider cumulative ballast 

discharges from multiple ships rather 

than just individual discharges from 

single ships, and examine the 

assumption that an initial population 

released from an individual ship is 

completely separate and isolated from 

other organisms released in the same 

area, since several discharges in the 

same area may build a population to 

viability before extinction can occur. 

The Coast Guard acknowledges this 

comment and will take this opportunity 

to clarify. Based on available data, the 

analysis focused explicitly on a single 

discharge. In order to address the 

broader question of the effect of the 

proposed BWM measures on the rate of 

species introductions from multiple 

discharges, the Coast Guard would 

require information about the number, 

magnitude, and timing of the multiple 

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discharges and about the species present 

in each discharge. As identified in the 

NRC report, there are data gaps (‘‘a 

profound lack of data and information’’) 

and therefore, there is no presently 

available information on multiple 

discharges. As recommended by NRC, 

models need to be developed to assess 

these risks and to link to new 

information as they become available. 

The Coast Guard will consider models 

that may be available during their 

practicability review under NISA. This 

may provide additional information to 

address the risk associated with 

multiple ballast discharges. 

One commenter claimed that the 

analysis assumes that ‘‘a percentage 

reduction in abundance is directly and 

linearly related to reduction in 

successful invasion probability.’’ The 

Coast Guard disagrees with this 

comment. The relationship between a 

percentage reduction in abundance and 

the probability of successful invasion is 

not assumed, it is based on the 

underlying diffusion model for 

population growth. Furthermore, the 

relationship is not specifically linear for 

this model; reducing initial abundance 

by a factor f increases the probability of 

extinction (i.e., unsuccessful invasion) 

by a factor f¥c where the parameter c 

depends on the parameters of the 

population model. 

A commenter stated that it would be 

helpful for the DPEIS to give at least 

some consideration to organisms 10 

micrometers and smaller, given the 

potential for pathogenic microorganisms 

to be transported in ballast water, using 

the framework adopted in Appendix A 

for larger organisms. Another 

commenter was concerned that the 

technical approach in the DPEIS does 

not adequately consider pathogens in 

the analysis. The Coast Guard disagrees 

with these comments. Microorganisms 

and pathogens were considered 

throughout development of the BWDS 

alternatives and are included in the 

BWDS in the form of indicator species. 

The PVA analysis in Appendix A was 

not applied to microorganisms because, 

for smaller organisms, the lower bound 

of the mean density range is already 

below the limits of alternatives 2 

through 4 and that the Coast Guard was 

not aware of any basis for a scientific, 

defensible, and enforceable discharge 

standard for microorganisms. 

One commenter stated that the 

technical approach to justify the 

proposed standards needs to include the 

transportation of bacterial and viral NIS 

pathogens, including the fish-killing 

Viral Hemorrhagic Septicemia (VHS) 

virus, by larger NIS that are infected. 

The commenter said that ballast water 

discharge containing infected organisms 

could transmit the pathogens, whether 

the host is alive or dead. 

The Coast Guard agrees with this 

comment. Microorganisms and 

pathogens were considered throughout 

development of the BWDS alternatives 

and are included in the standards 

themselves in the form of indicator 

species. The analysis’ technical 

approach addressed the two larger size 

classes of organisms in alternatives 2 

through 4, not microorganisms, given 

that for smaller organisms, the lower 

bound of the mean density range is 

already below the limits of alternatives 

2 through 4. The Coast Guard was not 

aware of any basis for a scientific, 

defensible, and enforceable discharge 

standard for microorganisms. 

One commenter stated that the DPEIS 

assumption for the PVA model, that N(t) 

follows geometric Brownian Motion, 

should be better clarified and defined, 

and is probably inappropriate for larger 

organisms than the smaller than 50 

micrometer class, since larger organisms 

move based on several variables such as 

habitat and water temperature (which 

could also affect motion of organisms 

smaller than 50 micrometers). 

The Coast Guard disagrees with the 

comment. The diffusion model does not 

assume that individuals do not move in 

response to environmental factors. It is 

possible that the commenter confused 

the population model—which is called 

Brownian motion—with a model of the 

same name of the movement of 

individuals. 

One commenter stated that the 

complexity of predicting the 

introduction and establishment of NIS 

and the lack of the necessary detailed 

information do not justify the Coast 

Guard’s use of a ‘‘generic data-poor 

approach’’ to analysis. The commenter 

also questioned whether PVA is 

appropriate or useful for an unknown, 

large number of different species with 

differing characteristics and dynamics 

that may be present within a ballast 

tank, since the Coast Guard states ‘‘PVA 

is typically used to assess the status of 

a particular population and therefore 

typically involves the development of a 

model of each population of interest 

separately,’’ and is ‘‘a routine tool for 

assessing the dynamics and extinction 

properties of a single population.’’ 

The Coast Guard notes that the 

commenter’s acknowledgment of the 

lack of detailed information implies that 

any approach will be ‘‘data-poor.’’ The 

diffusion model PVA approach used in 

the DPEIS is the best available to 

science that is appropriate for this 

purpose. The application of PVA to ‘‘an 

unknown (but large) number of different 

species’’ was necessitated by the 

problem at hand: namely, to evaluate 

alternative national standards for BWM. 

The diffusion model used here is quite 

general and applicable to different 

populations. The values of the 

parameters of this model are likely to 

vary from species to species and 

environment to environment. To 

account for this, the analysis considered 

a reasonable range of parameter values. 

As discussed in the NRC report, the 

PVA model is acknowledged as one of 

a group of models that can assess the 

relationship between invasion risk and 

propagule pressure. The NRC report 

goes on to conclude that ‘‘models of any 

kind are only as informative as their 

input data. In the case of ballast water, 

both invasion risk and organisms 

density discharged from ballast water 

are characterized by considerable and 

largely unquantified, uncertainty.’’ 

One commenter stated that there are 

gaps in the knowledge of invasion 

biology required to assess the impacts of 

a treatment standard and the relative 

degree of added benefit as compared to 

BWE. The Coast Guard acknowledges 

this comment. Although the abundance 

of scientific information on aquatic NIS 

is not ideal, the Coast Guard conducted 

a scientifically based analysis to predict 

the relative probability of NIS 

establishment for the discharge standard 

alternatives in the DPEIS. 

One commenter suggested that the 

statement from DPEIS Appendix A that 

‘‘considerable uncertainty attaches to 

the estimate of the extinction 

probability factor and the mean rate of 

successful introductions relative to the 

baseline’’ needs to be included as a 

disclaimer in the main body of the PEIS. 

The Coast Guard agrees and made that 

addition in the FPEIS. 

One commenter stated that separate 

risk analysis and assumptions are 

needed for the freshwater environment 

on the Great Lakes and offered general 

information and references on salinity 

toxicity effects, expected number of 

future invasions, and BWE 

effectiveness. The Coast Guard disagrees 

with this comment. Given that the PEIS 

is programmatic to apply to the wide 

variety of ecosystems in the affected 

environment and the generic nature of 

the PVA diffusion model, the analysis is 

applicable over the range of the 

impacted area. 

Two commenters questioned the 

assumed range of 0.001 to 0.1 of for the 

values of c, the biological population 

parameter. The first commenter stated 

that the instantaneous growth rates for 

many planktonic organisms are wellknown and others can easily be 

determined experimentally. The second 

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commenter stated that there is no 

justification for the selection of this 

range, and no discussion of whether 

populations might typically tend 

towards either end. The first commenter 

further stated that the values for the 

statistical representation of the 

estimated total initial number of 

organisms released in a single ballast 

water discharge is extremely variable 

and questioned how the values can give 

a good representation of the number of 

organisms discharged from a typical 

ballast tank. 

The Coast Guard neither agrees nor 

disagrees with these comments. As we 

explained in Appendix A of the DPEIS, 

we chose this range to reflect the best 

available estimates of the extinction 

probability for species introduced 

through ballast water discharge. The 

paper by Calbet and Landry (2004) 

provides daily growth rates for 

planktonic organisms in their native 

habitats. A central issue regarding NIS 

is the fate of organisms introduced into 

habitats that are not their native ones. 

Furthermore, the critical parameter c 

depends not only on the growth rate of 

a population, but also on its variability. 

The values characterizing the initial 

number of organisms are based on the 

work of Minton et al. (2005) and provide 

the best available representation of 

variability in the number of organisms 

released in a single ballast water 

discharge. 

One commenter stated that the 

assumptions that the ballast water of a 

single vessel contains 12 ‘‘new’’ species, 

that the most abundant is 50 percent of 

the total abundance, and that the 

ordered relative abundances follow the 

geometric model is an ‘‘extremely huge’’ 

set of assumptions to make and there is 

lack of reasoning behind them. 

Furthermore, the commenter was 

concerned that a large number of 

species may have been missed, since the 

12 value comes from a study evaluating 

organisms of a different size class than 

the alternatives, and was concerned that 

there is no presentation of variation 

around the mean for 12 new species. 

The Coast Guard disagrees with this 

comment. We provided the rationale for 

each assumption in Appendix A of the 

DPEIS, which states that the assumed 

values were based on the paper by 

Smith, et al. (1999). Despite its 

limitations, this study reflects the best 

available information on the species 

composition of ballast water. The 

application of the PVA diffusion model 

was conducted by experts in the 

biological and statistical fields and 

reviewed by others, including 

cooperating agencies. The PVA 

diffusion model provided a generic, 

non-species-specific model that, in 

conjunction with other information, was 

used to provide insight into the 

potential relative impacts of the 

alternatives, based on probability of NIS 

establishment. 

One commenter stated that there 

should be more consistent use of lower 

and upper case letters for variables/ 

parameters in the DPEIS, and that the 

clarity of the extinction probability 

equation would be improved by 

indicating the baseline extinction 

probability with a different term/ 

subscript, providing more information 

on its derivation, and correcting the 

relationship to read fe = f¥c fe = f¥c. The 

commenter also suggested that q(m) (the 

probability that at least one species is 

successfully introduced) should be 

defined in the DPEIS body text and that 

Ne (the percent increase in q(m) over 

the baseline scenarios) should be 

defined. 

The Coast Guard disagrees with the 

comment regarding the extinction 

probability equation. The equation 

follows from simple algebraic 

substitution and no further details 

should be needed. On the notation for 

baseline extinction probability, 

Appendix A already distinguishes 

between baseline extinction probability 

and extinction probability when initial 

abundance is reduced by a factor f. The 

Coast Guard agrees the correct 

relationship is fe = f¥c fe = f¥c and 

changed the FPEIS from ‘‘extinction 

probability factor fe = f¥c fe = f¥c’’ to 

‘‘extinction probability factor fe = f¥c fe

= f¥c’’, as in Equation (7). The Coast 

Guard acknowledges the comment 

regarding the terms q(m) and Ne and 

made changes in the FPEIS, as 

appropriate. 

One commenter stated that there is no 

sensitivity analysis or quantification of 

model error with which to evaluate the 

PVA model used in the DPEIS. The 

Coast Guard disagrees with this 

comment. Throughout the DPEIS, 

results are given for alternative values of 

key parameters. 

One commenter stated that discussion 

in the DPEIS on the importance of 

default values for multiple species is 

incomplete, and that examples of 

predictions for probability of at least 

one introduction in multiple species 

scenarios could convey a false sense of 

security. The commenter also stated that 

using a default value of only twice the 

median number of organisms released 

results in a nonzero, albeit small, 

probability of at least one species being 

introduced in the alternative 4 scenario 

and that this sensitivity issue should be 

discussed in the DPEIS. 

The Coast Guard disagrees with the 

comment. We provided the rationale for 

these default values in Appendix A of 

the DPEIS. The commenter’s own 

calculation of the effect of doubling the 

default of the total number of organisms 

in a discharge event shows that these 

results are not highly sensitive to 

changes in the default values. 

One commenter stated that the 

modeling results for multiple species 

support the conclusion that more 

stringent treatment alternatives will 

substantially reduce the likelihood of 

new NIS introductions via ballast water. 

The Coast Guard acknowledges this 

comment, but notes that the correctness 

of this statement depends on the 

definition of ‘‘substantially.’’ 

One commenter responded to a 

question in the NPRM asking for any 

studies on the effects of propagule 

pressure on successful establishment of 

a NIS in aquatic ecosystems by referring 

to the research being performed by the 

Canadian Aquatic Invasive Species 

Network in relation to shipping mode 

and route, and factors affecting 

establishment success. The Coast Guard 

may use this information in a future 

evaluation of discharge standards. The 

Coast Guard will continue to follow the 

relevant literature in this area. 

One commenter stated that it seems, 

from the relative effectiveness results of 

the analysis of BWDS alternatives, that 

the approach assumes that discharges in 

compliance with the different 

alternatives contain the stated number 

of organisms in the respective groups, 

and that the proposed phase-one 

standard is equivalent to the IMO 

discharge standard. The Coast Guard 

agrees with the comment. 

One commenter cited an error in 

Appendix A, table 5–8. For the scenario 

with Ne = 100, c = 0.00008 and 

alternative 3, q(m) should be 0.00025, 

not 0.0025. The Coast Guard agrees with 

this comment and made this correction 

in the FPEIS. Ne is the percent increase 

in q(m) over the baseline scenarios, q(m) 

is the probability that at least one 

species is successfully introduced, and 

c is the biological population parameter. 

One commenter stated there is no 

evidence to suggest that the standards 

outlined in alternatives 1 through 4 are 

biological thresholds that represent 

minimum viable populations for all 

taxonomic groups. The Coast Guard 

agrees with this comment, however, this 

is not relevant to the analysis. The 

BWDS alternatives do not represent the 

minimum viable populations for all 

taxonomic groups. We developed these 

alternatives through a rigorous process 

including three separate expert panel 

workshops, public scoping meetings, 

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and cooperating agency participation, 

and the Coast Guard based the BWDS 

alternatives on an allowable 

concentration of organisms larger than a 

specified size criterion, providing a 

balance between protection and 

practicability and taking into account 

the expected capabilities of technology. 

DPEIS Affected Environment Comments 

One commenter suggested that the 

Coast Guard expand the scope of the 

DPEIS to encompass the ‘‘big picture’’ 

by including other adjacent, 

interconnected water bodies, such as the 

Canadian waters of the Great Lakes, and 

including other interacting programs 

such as U.S. Department of 

Agriculture’s Animal and Plant Health 

Inspection Service (APHIS). The 

commenter also suggested including 

information in the DPEIS from an 

authority on VHS and Federal agency 

publications on treatment methods. 

The Coast Guard disagrees with this 

comment. The DPEIS is a programmatic 

document, and areas were addressed at 

the national and ecosystem level, 

including a freshwater ecosystems 

section. APHIS participated in the 

preparation of the DPEIS as a 

cooperating agency in accordance with 

40 CFR 1501.6. BWMS were not 

included in the DPEIS and methods to 

achieve the standard will be evaluated 

in separate environmental analysis as 

part of the approval process. Vessels 

with BWMS enrolled in STEP are 

included in the FPEIS as a means 

evidence the practicability of the BWDS 

proposed in this rule. 

Another commenter suggested 

including a major western freshwater 

system under the DPEIS section on 

freshwater ecosystems and cited the 

Columbia River and its watershed as 

very significant. The Coast Guard agrees 

with this comment, and added the 

Columbia River as an additional 

example in the FPEIS. 

One commenter suggested separating 

public health and shipping safety, and 

expanding the latter in the Affected 

Environment chapter of the DPEIS. The 

Coast Guard agrees and made these 

changes in the FPEIS. 

One commenter stated that the 

proposed rule and DPEIS are both overinclusive (too many vessels and areas) 

and under-inclusive (some remedies not 

considered, such as using other water or 

other ballasting methods). The Coast 

Guard made changes to the final rule, 

including revised applicability to 

include additional exemptions and 

clarification of other water and 

ballasting methods, which address the 

examples given as evidence that the 

NPRM and DPEIS were both over- and 

under-inclusive. These changes are 

summarized in this preamble in V.A. 

Summary of Changes from the NPRM. 

One commenter explained that the 

physical environment of the Great Lakes 

is more susceptible to ecosystem 

damage due to isolation and slow 

flushing rates as compared with 

estuarine and ocean coastal areas. The 

Coast Guard notes this comment, but 

did not include Great Lakes flushing 

rates in the FPEIS because it analyzed 

the BWDS alternatives from a 

nationwide scope, not by specific 

geographic area. 

One commenter stated that since the 

Great Lakes are one of the primary 

freshwater resources affected by BWDS, 

the DPEIS could include additional 

Great Lakes-specific information and 

references. The commenter further 

suggested that it may be useful to 

highlight Lake Superior as a less 

stressed system than the other Great 

Lakes and discuss the Great Lakes 

Fishery Commission’s fishery 

management objectives pertaining to 

habitat in the Great Lakes. The Coast 

Guard disagrees with this comment. The 

Great Lakes were addressed as a whole 

in the DPEIS, not individually. 

Two commenters stated that the Coast 

Guard recognizes the environmental 

damage caused by NIS, and they 

explained that the rapid spread of 

freshwater invaders from the Great 

Lakes illustrates that protecting the 

Great Lakes from ballast-mediated 

invasions protects freshwater 

ecosystems across North America. The 

Coast Guard acknowledges these 

comments. 

One commenter suggested adding 

Asian clams to the DPEIS discussion of 

the round goby and updating the 

analysis to include costs of the second 

underwater electric barrier. The same 

commenter suggested modifying the 

statement about the abundance of 

Diporeia in Lakes Michigan and Huron 

from non-existent to vastly declined, 

and highlighting additional examples of 

food web changes related to NIS. The 

Coast Guard disagrees with the first 

comment. The round goby was cited as 

an example and does not need 

elaboration. The remaining changes 

were made, as appropriate. 

One commenter suggested that waters 

within many National Park units may 

represent the best available examples of 

healthy marine ecosystems, and should 

be recognized explicitly in the DPEIS 

and NPRM via a clear prohibition of 

ballast water discharge within their 

boundaries. The Coast Guard disagrees 

with the recommendation for a blanket 

prohibition of ballast water discharge 

within National Park waters. We note, 

however, that 33 CFR 151.2050 requires 

vessel owners to avoid ballast water 

discharge in marine sanctuaries, marine 

preserves, marine parks, or coral reefs. 

One commenter stated that habitat 

destruction and loss should be included 

as a stressor impacting marine, 

estuarine, and freshwater environments, 

being that it has been implicated as the 

greatest threat to imperiled species and 

gave a reference. The commenter also 

stated that the other stressors and 

examples in the DPEIS need to have 

citations for the references used. The 

Coast Guard disagrees with the 

comment. Habitat destruction and loss 

already are mentioned and cited in 

several places in the DPEIS. 

One commenter stated that the DPEIS 

doesn’t quantify some of the worst NIS, 

such as zebra mussels. The commenter 

also takes issue with the apparent focus 

on populated aquatic environments that 

are already compromised by NIS at the 

expense of protecting all aquatic 

environments, from the pristine to the 

heavily used. The commenter said that 

when all the economic benefits of 

protecting environments from NIS are 

evaluated, a preventative mode is more 

cost effective than mitigating undesired 

effects. 

The Coast Guard disagrees with this 

comment. The effects of zebra mussels 

and other NIS are mentioned in several 

places in the DPEIS. A BWDS under 

NANPCA/NISA is intended as a 

practicable standard that significantly 

reduces the risk of invasions in all 

aquatic environments. 

One commenter suggested that the 

Coast Guard define ‘‘dead zones,’’ or use 

the terms ‘‘anoxia’’ or ‘‘hypoxia’’ to 

better describe the situation. The Coast 

Guard agrees with this comment, and 

made the changes in the FPEIS to clarify 

that there will be fewer introductions 

and spreading of NIS in comparison to 

a scenario without a BWDS. 

One commenter pointed out an 

apparent inconsistency where the DPEIS 

states two different numbers of NIS 

reportedly established in San Francisco 

Bay. The Coast Guard made the changes 

in the FPEIS. 

One commenter suggested that the 

Coast Guard explain what is meant by 

‘‘increased competition’’ in the DPEIS 

description of impacts on bird health. 

The Coast Guard made the changes in 

the FPEIS. 

One commenter suggested that the 

Coast Guard update all of the economic 

information in the DPEIS Economic 

Status section to reflect the recent 

downturn in the economy. The 

commenter specified that they believed 

the statement that tourism and 

recreation have provided all of the job 

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growth to the U.S. ocean economy 

within the last decade was outdated and 

not accurately cited. The Coast Guard 

disagrees with this comment, as the 

socioeconomic information in the DPEIS 

is intended to represent a longer term, 

e.g., a decade or more. We verified the 

citation and the statement is accurately 

cited. 

One commenter pointed out that 

billions of dollars are spent and 

anticipated for dealing with NIS. The 

commenter also felt that the value of 

Michigan’s extensive water resources 

and their uses must be taken into 

account, and that the cost of not 

pursuing a more rigorous standard for 

the Great Lakes is billions of dollars 

annually and will result in incalculable 

natural resource losses. The Coast Guard 

neither agrees nor disagrees with this 

comment, however, the PEIS is a 

programmatic document, and areas, 

including socioeconomic impacts such 

as water resources, were addressed at 

the national and ecosystem level not the 

State level. 

PEIS Alternatives Comments 

One commenter expressed general 

support of the DPEIS, stating their 

appreciation of the use of the best 

available science and models to justify 

the numeric discharge standard. The 

Coast Guard notes that the standard 

from NANPCA, as amended by NISA, is 

for the Coast Guard to use ‘‘best 

scientific information available,’’ not 

‘‘best available science.’’ 

One commenter stated that the sizes 

range for the alternative standards 

should extend to below 0.01 

micrometers, to incorporate most 

pathogenic viruses, including the VHS 

fish virus. The commenter also said that 

the possibility of man-made pathogens 

or fragments of viruses which could be 

used to contaminate freshwater city 

water supplies on the Great Lakes and 

deserve special treatment due to their 

risk of adversely affecting most native 

fisheries in the Great Lakes and adjacent 

waters. 

The Coast Guard disagrees with this 

comment. Three separate expert panel 

workshops, public scoping meetings, 

and cooperating agency participation 

contributed to progressive development 

of the BWDS alternatives. As a result, 

the Coast Guard decided that pathogenic 

microorganisms, which include viruses, 

would be represented in terms of 

indicator bacteria. The BWDS 

alternatives do not apply by specific 

area. 

One commenter recommended that 

the PEIS define organism size classes for 

BWDS alternatives in more detail by 

specifying where on the organism the 

measurement is done and to use 

organism taxa in the categorization. The 

commenter also recommended 

clarification on whether chain forming 

algae should be classified by size of 

individual cells or size of colonies. The 

commenter stressed that the Coast 

Guard must keep in mind the ultimate 

goals of reducing or eliminating the risk 

of invasive species when classifying 

organisms by size. The Coast Guard 

reviewed the information provided but 

did not make changes in the FPEIS, as 

we believe there is sufficient 

information in the FPEIS as it stands. 

One commenter stated that he or she 

does not support a no-action alternative. 

The Coast Guard appreciates the 

commenter’s input, however, the noaction alternative is used as a baseline 

in the environmental analysis, not as an 

action alternative. Council on 

Environmental Quality regulations 

require the Coast Guard to evaluate the 

no-action alternative. 40 CFR 

1502.14(d). 

One commenter stated that the 

discussion of the no-action alternative 

should include that a vessel-by-vessel 

approach is not practical, and that using 

BWE as the benchmark for system 

effectiveness is not sufficiently 

protective of the waters of the United 

States. The Coast Guard disagrees with 

this comment. Council on 

Environmental Quality regulations 

require the Coast Guard to evaluate the 

no-action alternative; it is used as a 

baseline in the environmental analysis, 

not as an action alternative. Id. 

One commenter stated that ballast 

water retention, part of the no-action 

alternative, would eliminate the 

introduction of species via ballast water 

discharge, thus it is not appropriate for 

the DPEIS to state that the no-action 

alternative will not eliminate the 

introduction and spread of NIS. The 

commenter further stated that the DPEIS 

should make it clear that, while a BWDS 

is more protective than BWE, ballast 

water retention is more protective than 

a BWDS, and that many vessels do not 

have to take any BWM actions under 

current regulations and can release 

untreated coastal ballast water. 

The Coast Guard disagrees with the 

comment. The no-action alternative is 

intended to reflect a set of options, any 

of which a vessel may use or not use, 

due to preferences or capabilities. Thus 

the no-action alternative as a whole will 

not eliminate the introduction and 

spread of NIS. The Coast Guard 

acknowledges in the DPEIS that some 

vessels may not be able to conduct BWE 

depending on vessel design, age, load, 

sea conditions, and safety concerns. 

One commenter stated that it is 

confusing to include ballast water 

treatment under the no-action 

alternative, and wondered if the Coast 

Guard intended to state that treatment 

that is equal to or better than BWE, 

without the development of a BWDS, is 

part of the no-action alternative. The 

Coast Guard disagrees with this 

comment. The no-action alternative 

reflects the baseline of current BWM 

requirements, which includes the 

option of using an approved treatment 

that is equal to or better than BWE. The 

no-action alternative is intended to 

reflect a set of options, any of which a 

vessel may use or not use, due to 

preferences or capabilities. 

A commenter stated that the DPEIS 

overstates the difficulty of achieving 

alternative 5 because a number of 

sterilization options listed in Appendix 

F, including gaseous chlorine, which is 

widely used at municipal water 

treatment facilities, essentially sterilize 

drinking water. This commenter also 

said that the DPEIS further overstates 

alternative 5’s difficulty by asserting 

that alternative 5 is the same as 

elimination of ballast water discharge. 

The Coast Guard disagrees with this 

comment. Specific BWMS were not 

included in the DPEIS and the BWMS 

analyzed in Appendix F of the FPEIS is 

limited to providing a rational basis of 

the practicability of a proposed 

alternative. Methods to achieve the 

standard will be evaluated in separate 

environmental analysis. The DPEIS did 

not state that alternative 5 is the same 

as elimination of ballast water discharge 

but, rather, that the most feasible 

approach for achieving it is through the 

elimination of ballast water discharge. 

Two commenters stated that, in 1997, 

Congress required the Coast Guard to 

examine the feasibility of modifying the 

Valdez Marine Terminal to prevent the 

introduction of NIS, and suggested that 

such a study be included in the docket 

and examined in the PEIS. They further 

suggested that the PEIS should include 

an alternative that examines whether a 

NIS treatment option can be accelerated 

at the Valdez Marine Terminal ahead of 

the proposed phase-one and phase-two 

schedules. The commenters also stated 

there are onshore treatment solutions for 

vessels, including crude oil carriers. 

The Coast Guard disagrees with this 

comment. Vessels discharging ballast 

water to shore or vessel/barge-based 

treatment facilities essentially achieve 

alternative 5 (near sterilization) by not 

discharging to the waters of the United 

States. It would not be practicable to 

develop a PEIS alternative involving 

shoreside facilities, as there are not 

currently any available that are designed 

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to remove living organisms from ballast 

water. They can be viewed as one of the 

potential options available to vessels. 

One commenter stated that ballast 

water treatment must ensure that ballast 

does not contain NIS of sufficient 

quantity to allow survival and 

inoculation, and that DPEIS alternatives 

2 through 4 do not assure this standard 

can be met, but that alterative 5 does. 

This commenter and one other stated 

that the alternative 2 standard is not 

appropriate for the entire United States, 

because site-specific treatment options 

may be able to achieve treatment that 

exceeds the alternative 2 standard. The 

first commenter stated that alternative 5 

should be the goal, with reduced 

standards allowed only when it is 

proven technically infeasible to meet 

this goal. 

The Coast Guard disagrees with these 

comments. The DPEIS evaluated the 

BWDS alternatives, not the means of 

meeting them. Any methods to achieve 

the standard, including ballast water 

treatment, will be evaluated in a 

separate environmental analysis as part 

of the approval process. However, as 

stated previously, the FPEIS does 

analyze STEP vessels with BWMS to 

determine the practicability of the 

BWDS set forth in this rule. The goal of 

a BWDS, as stated in the DPEIS, is the 

reduction of NIS introductions and 

spread and associated impacts. 

One commenter stated that the Coast 

Guard should attempt to implement the 

most protective alternative available in 

the absence of detailed environmental 

data to determine the population level 

at which an introduced species will 

survive. The commenter also noted the 

difficulty in comparing the effectiveness 

of alternatives 1 through 4, and 

acknowledged that alternative 5 will not 

remove the risk of all NIS introductions. 

The commenter further recommended 

that alternative treatment systems, such 

as onshore facilities, be considered in 

more detail during the practicability 

review. 

The Coast Guard disagrees with this 

comment. NEPA does not require a 

Federal agency to select the most 

environmentally protective alternative. 

Currently, there are no U.S. typeapproved BWMS intended for use 

onboard vessels that can practicably and 

safely achieve complete sterilization of 

ballast water. Although difficult, the 

Coast Guard made a scientificallyfounded evaluation of the alternatives. 

The preferred alternative was developed 

taking into consideration environmental 

protection and practicability, including 

economic and technical aspects. 

The Coast Guard also disagrees with 

the commenter’s suggestion to take 

onshore facilities into account during 

practicability reviews. The purpose of 

the practicability review is not to 

establish that there are alternatives to 

shipboard BWMS capable of meeting 

the applicable BWDS, but to determine 

specifically whether such shipboard 

BWMS are practicably available. The 

presence of onshore facilities will not 

factor into that analysis. 

One commenter requested that the 

DPEIS be revised to provide a complete 

quantitative analysis of alternative 5, as 

required by NEPA. The Coast Guard 

disagrees with this comment. NEPA 

does not require a quantitative analysis 

of each alternative, but rather ‘‘to 

document and define changes in the 

natural environment, including the 

plant and animal systems, and to 

accumulate necessary data and other 

information for a continuing analysis of 

these changes or trends and an 

interpretation of their underlying 

causes.’’ Since alternative 5 is the only 

alternative that assures that no living 

organisms larger than 0.1 micrometer 

are released via ballast water the 

impacts on environmental resources are 

expected to be minimal. 

One commenter stated that the Coast 

Guard’s preferred alternative does not 

achieve a sufficient reduction in the 

predicted mean rate of successful NIS 

introductions. The Coast Guard 

disagrees with this comment. Under 

NISA, Congress authorized the use of 

environmentally sound alternative 

BWM methods that are at least as 

effective as BWE in preventing and 

controlling infestations of aquatic NIS. 

The preferred alternative achieves that 

requirement. 

One commenter provided the 

information that over 80 percent of 

vessels arriving in California retain all 

ballast onboard, to refute the DPEIS 

statement that few vessels have the 

ability to retain ballast onboard. The 

commenter further stated that vessels 

may conduct internal ballast transfers or 

alter cargo handling operations to 

reduce the need to de-ballast. 

The Coast Guard disagrees with the 

comment. The Coast Guard does not 

believe that such retention percentages 

are applicable to many vessels calling at 

U.S. ports. Ballasting operations depend 

on whether vessels are offloading or 

loading cargo, on vessels’ ability to carry 

near-maximum cargo loads on all legs of 

a voyage, and on the design and 

configuration of the vessel (e.g., bulk 

carriers cannot retain ballast water, 

whereas container vessels may have the 

physical capacity to do so). 

One commenter stated that the PEIS 

should note that the existing BWM 

strategy (mid-ocean BWE) is not 

enforceable to any degree of accuracy. 

This comment is beyond the scope of 

the DPEIS. We note, however, that the 

Coast Guard enforces the BWE 

requirement during both port state 

control boardings and annual 

inspections of vessels, and that there 

have been a variety of civil penalty 

actions which directly contradict the 

commenter’s assertion. 

One commenter stated that since 

alternative 2 is not the most 

environmentally protective one, the 

Coast Guard must further discuss why 

this alternative is preferred. The Coast 

Guard’s environmental and 

socioeconomic rationale for selecting 

alternative 2 as the preferred alternative 

is stated in the FPEIS. 

One commenter pointed out that the 

DPEIS states that a 2001 workshop in 

Oakland, CA recommended, as a longterm proposal, the complete removal or 

inactivity in ballast water for the first 

two functional groups (coastal 

holoplankton-meroplankton-demersals 

and phytoplankton-cysts-algal 

propagules). The commenter wanted to 

know why this is not considered as a 

long term goal, even if it were to be a 

protracted implementation. 

The Coast Guard used information 

from the 2001 workshop and from other 

expert panel workshops, public scoping 

meetings, cooperating agency 

participation, and other sources in 

developing the proposed BWDS. The 

goal of a BWDS is prevention of NIS 

introductions and spread and associated 

impacts. The phase-two standard 

proposed in the NPRM was based on the 

most stringent quantitative standards 

currently in place in a state. However, 

under NANPCA/NISA, any proposal of 

a standard must consider practicability, 

which accounts for the non-inclusion of 

a no living organism standard. 

PEIS Environmental Consequences 

One commenter stated that the phaseone standard is less effective than BWE. 

The Coast Guard disagrees with this 

comment. Chapter 4 and appendix A of 

the PEIS show that alternatives 2 and 3 

are more effective than the no-action 

alternative. 

One commenter stated that nektonic 

organisms were not included in chapter 

4 of the DPEIS. The Coast Guard 

disagrees with this comment. Nektonic 

organisms (e.g. fish), though not directly 

addressed as a group, are indirectly 

addressed throughout the FPEIS. 

One commenter suggested that ballast 

water discharge is one of the key vectors 

for viral transmission, especially VHS. 

The commenter said that, with no 

special regulation for Great Lakes 

vessels, viruses (such as VHS) could 

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spread through Lake Superior and 

possibly move into other waterways. 

The Coast Guard has not identified 

any studies that directly identify ballast 

water as a documented VHS vector in 

the Great Lakes. There is a need for 

further information on possible vectors, 

including ballast water, vessel fouling, 

and live and dead fish. The Coast Guard 

notes that the BWDS alternatives do not 

generally apply by specific geographic 

area, but rather are nationwide in scope. 

However, we will keep this comment in 

mind as we conduct more research into 

the effects of implementing a BWDS in 

the Great Lakes, as well as nationwide. 

One commenter stated that impacts of 

a BWDS need to be clarified as far as it 

would affect ecology, the economy, 

industry, and society, among other 

aspects. The Coast Guard believes that 

the DPEIS addressed those issues at the 

programmatic level. 

One commenter suggested that the 

sentence ‘‘Economic sectors dependent 

on the health of aquatic and coastal 

resources would benefit from overall 

healthier ecosystems with fewer 

invasive species’’ in chapter 4 was 

misleading because a BWDS will not 

result in fewer existing invasive NIS, 

but fewer introductions in the future. 

The Coast Guard agrees with this 

comment and changed the sentence in 

the FPEIS to clarify that there will be 

fewer introductions and spreading of 

NIS in comparison to a scenario without 

a BWDS. 

One commenter stated that vessels 

may be able to meet the preferred 

alternative for organisms larger than 50 

micrometers without BWE or treatment. 

The Coast Guard neither agrees nor 

disagrees with this statement, but notes 

that the BWDS is to be used for 

measuring the effectiveness of BWMS 

during the approval process in addition 

to measuring compliance from vessels at 

the point of discharge. It is not intended 

that vessels be allowed to assert their 

non-BWMS method of dealing with 

ballast water meets the BWDS. 

One commenter stated that 

heterotrophic bacteria may also bloom 

within a ballast tank as a result of the 

increased substrate. The Coast Guard 

agrees with this comment, but saw no 

need to make changes to the FPEIS. 

One commenter suggested that hull 

fouling is a larger factor than ballast 

water for NIS introductions from 

vessels. The Coast Guard acknowledges 

that biofouling is mentioned in the 

DPEIS, however, this comment is 

beyond the scope of this rule. We note 

that 33 CFR 151.2050 does include some 

provisions for preventing hull fouling. 

One commenter stated that a cited 

author never intended to create a link 

between the economics of development 

of a BWDS and an increase in hull 

fouling. The Coast Guard has reviewed 

the use of this author’s work and 

removed that text from the FPEIS. 

One commenter noted that the threat 

of species introductions comes not only 

from foreign vessels, but also from 

vessels operating in the coastal waters of 

the United States. The Coast Guard 

agrees with this statement, and notes 

that the NPRM proposed requiring all 

vessels to comply with the BWDS. For 

reasons discussed elsewhere in this 

document, some of those requirements 

are being reevaluated. The PEIS does 

not intend to imply that NIS 

introductions come only from foreign 

vessels. 

One commenter pointed out that the 

impacts of seawater should be 

considered regarding ballast water 

discharge. This comment is beyond the 

scope of this rule, which evaluates the 

impacts of NIS, but not the seawater in 

the discharge. 

One commenter observed that the 

analyses of BWDS efficacy relative to 

BWE fails to account for the differences 

in potential risk associated with species 

that are sourced from different 

biogeographical habitats. The Coast 

Guard disagrees with this comment. The 

impacts of NIS invasions necessarily 

evaluate species that are transferred 

from one biogeographical area to a 

different one, and the effects, including 

risk, are described in the DPEIS. 

One commenter stated that the Coast 

Guard should fully consider the 

economic input required for the 

alternatives. The Coast Guard agrees 

with this comment, and notes that the 

preferred alternative was developed 

taking into consideration environmental 

protection and practicability, including 

but not limited to economic and 

technical considerations. 

One commenter stated that the 

evaluation of extinction probability 

applies only to individual ballast 

discharges from single ships without 

considering cumulative discharges from 

multiple ships, which could 

substantially increase the initial 

population of released organisms. The 

Coast Guard acknowledges that the PVA 

diffusion model provided a generic, non 

species-specific model that we used, in 

conjunction with other information, to 

provide insight into the potential 

relative impacts of the alternatives, i.e., 

the focus was on relative comparison of 

alternatives in terms of probability of 

NIS establishment. Cumulative impacts 

at the macro level are addressed in the 

FPEIS. 

One commenter suggested that the 

Coast Guard insert the phrase ‘‘with the 

implementation of a federal BWDS’’ into 

page 4–23, line 34, of the DPEIS, where 

it states, ‘‘Thus, if the volume of 

shipping remains at the same level, 

ballast-mediated invasions are likely to 

be reduced.’’ The Coast Guard disagrees 

with this comment. The sentence in the 

Cumulative Impacts section that the 

commenter referred to, as well as the 

following sentence, set the context for 

the last sentence in that paragraph, 

‘‘Thus, a BWDS would be expected to 

decrease NIS introductions from distinct 

[ballast water] discharge events, but the 

total number of introductions could still 

increase due to increases in global 

trade.’’ The commenter’s suggested 

change would alter the intended 

meaning. 

One commenter noted that if 

alternatives 2 through 4 can provide 

minor to major reductions, then 

alternative 5 should provide at least 

moderate to major reductions. The Coast 

Guard agrees with this comment. The 

DPEIS states that the impacts of NIS on 

the environment under alternative 5 

would likely be greatly reduced 

compared to the other alternatives. 

One commenter stated that there was 

vague language in specific sentences in 

the section on impacts of alternatives on 

listed species and habitat and in the 

cumulative impacts section of the 

Environmental Consequences, chapter 4 

of the DPEIS. The Coast Guard reviewed 

and corrected the cited sentences and 

made changes in the FPEIS, as 

appropriate. 

One commenter observed that the 8 

percent reduction of NIS between 10 

and 50 micrometers noted in the 

preferred alternative was not 

worthwhile given the effort. The Coast 

Guard disagrees with this comment. The 

preferred alternative was developed 

taking into consideration environmental 

protection and practicability, including 

economic and technical aspects. 

One commenter stated that the Coast 

Guard must send a consistency 

determination to the State of New York. 

The Coast Guard agrees with this 

comment. We submitted Initial Coastal 

Zone Management Consistency 

determinations to the 34 coastal states 

and territories, including New York, in 

March 2010. 

One commenter noted that the DPEIS 

failed to account for the differences in 

potential risk associated with species 

that are sourced from, and discharged 

into, low salinity habitats. The 

commenter also stated that Washington 

and Oregon will require a higher BWDS. 

The Coast Guard prepared a PEIS 

because a BWDS would impact a large 

geographic area and a wide variety of 

U.S. ecosystems. The PEIS does not 

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evaluate specific areas or ecosystems. 

Additionally, we note that the final rule 

does not preempt the States from setting 

more stringent standards. 

Two commenters stated that the Coast 

Guard’s own modeling in the NPRM and 

associated DPEIS shows that only the 

degree of NIS infestation of the Great 

Lakes from ballast water discharge 

changes with the various scenarios of 

implementation dates for the phased 

BWDS. The Coast Guard acknowledges 

this comment, but does not feel that any 

action is necessary. 

One commenter stated that the Coast 

Guard should perform additional 

scientific research to assess the 

effectiveness of current BWM efforts for 

coastal waters. The Coast Guard 

disagrees. The DPEIS sufficiently 

analyzed this issue for purposes of the 

rule. 

One commenter stated that the Coast 

Guard did not discuss details of 

enforcement or compare the 

enforceability of different alternatives in 

the DPEIS. The Coast Guard does not 

believe that the PEIS is the appropriate 

place to discuss enforcement details. 

One commenter stated that the Coast 

Guard should conduct a phase-one 

practicability review of the technical 

and economic barriers related to 

implementation of a BWDS for vessels 

operating primarily in the Great Lakes 

and St. Lawrence Seaway system. 

Another commenter stated that the 

precise risk of NIS introductions by 

domestic commercial vessels, 

particularly the domestic Great Lakes 

trade, requires further research. The 

commenter said that, therefore, 

application of the proposed rule to the 

ships in the domestic Great Lakes trade 

is inappropriate. 

The Coast Guard agrees with the 

intent of these comments. We note that, 

in general, a phase-one practicability 

review is effectively taking place 

through the type approval of systems to 

meet the IMO discharge standard, which 

is indicative of BWMS being available. 

However, as discussed in this preamble 

in V.A. Summary of Changes from the 

NPRM, we have revised the 

applicability in this final rule such that 

non-seagoing vessels; vessels that take 

on and discharge ballast exclusively in 

one COTP Zone; and seagoing vessels 

that operate in more than one COTP 

Zone and do not operate outside of the 

Exclusive Economic Zone (EEZ), and are 

less than or equal to 1,600 gross register 

tons or less than or equal to 3,000 gross 

tons (International Convention on 

Tonnage Measurement of Ships, 1969) 

will not need to comply with the BWDS 

at this time. We are continuing to 

analyze the practicability of 

implementing any BWDS to these 

vessels. We also intend to conduct 

additional research, as necessary. The 

results of which will be included in a 

notice or other rulemaking document. 

Miscellaneous Comments on the DPEIS 

Six commenters pointed out that the 

DPEIS contains no evidence to suggest 

that ballast water discharged by towing 

vessels and barges operating only on the 

U.S. inland waterways has resulted in or 

contributed to the introduction or 

spread of NIS. Five of these commenters 

further stated that the same comment 

also applies to towing vessels and 

barges operating within the same coastal 

ecosystem, and that they are not aware 

of a Coast Guard effort to analyze NBIC 

data to determine the role of vessels, 

particularly domestic towing vessels, in 

the introduction and spread of invasive 

NIS. 

An additional commenter pointed out 

that there is no evidence of NIS 

introduction or spread by towing vessels 

and barges operating primarily in U.S. 

coastal zones. Two commenters stated 

that it is unfair to regulate domestic 

towing vessels and barges with much 

smaller ballast water capacity than 

crude oil tankers in the U.S. coastwise 

trade which NISA exempts from BWM 

requirements. 

One commenter stated that requiring 

the installation of very expensive 

BWMS on thousands of towing vessels 

and barges with very limited ballast 

water capacity is cost-prohibitive or not 

cost-effective. The commenter argued 

that costs must be considered both in 

absolute terms and against lack of 

evidence that towing vessels or barges 

operating primarily in U.S. coastal 

zones have contributed to the 

introduction or spread of invasive 

species, their smaller volumes of ballast 

water, and technological and 

operational impediments to the 

installation of BWMS. 

These comments are not directly 

relevant to the DPEIS; they are instead 

comments on the NPRM itself. The 

Coast Guard has addressed the issue of 

applicability to towing vessels in our 

responses in this preamble in V.B.1 

Discussion of Comments: Applicability. 

One commenter recommended a 

study of species-by-species NIS risk 

analysis on the Great Lakes to focus the 

need for regulatory efforts on specific 

routes, where reducing the risk of 

species transfer would have the greatest 

benefit. The Coast Guard disagrees with 

this recommendation. It would not be 

practicable to develop risk profiles of 

specific routes, because risk profiles 

change as functions of the 

environmental characteristics of the 

locations, the traffic between them, and 

the introduction of new species by 

vessels and multiple non-ship vectors. 

One commenter stated that onshore 

ballast water treatment facility options 

must be examined by the Coast Guard 

in the PEIS since there are proven, 

technically-feasible onshore treatment 

solutions for vessels with dedicated 

trade routes. They suggested that the 

Valdez Marine Terminal could be 

retrofitted with NIS control to treat 

crude oil vessels engaged in foreign 

trade regulated under the proposed rule 

and crude oil vessels engaged in 

coastwise trade regulated under the 

Clean Water Act. 

The Coast Guard disagrees with this 

comment. The scope of the PEIS 

encompasses the standard for discharges 

from vessels, not an analysis of the 

means to achieve the standard. While 

discharge to shore is an option for 

vessels under the NPRM, provided there 

are facilities available, it is beyond the 

Coast Guard’s authority to require 

shoreside facilities in all ports. 

NANPCA, as amended by NISA, grants 

Coast Guard the authority to regulate 

vessel BWM practices, and this 

authority does not extend to onshore 

ballast water treatment facilities. 16 

U.S.C 4711. Ballast water discharged to 

a shore-side facility is not subject to the 

Coast Guard’s proposed BWDS as it 

would not be a discharge into waters of 

the United States from a vessel. 

Discharges to waters of the United 

States from such shoreside treatment 

facilities would be subject to regulation 

under the CWA NPDES permit program. 

One commenter stated that the 

proposed phase-one standard is 

biologically inadequate and inconsistent 

with the United States’ initial position 

in discussions during the development 

of the IMO discharge standard. This 

initial U.S. position was for a more 

stringent standard (less than 0.01 per m3

of water as the concentration standard 

for Zooplankton and less than 0.01 per 

mL for smaller organisms). 

The Coast Guard disagrees that the 

phase-one standard is ‘‘biologically 

inadequate’’. As described in the DPEIS, 

the standard will be more effective than 

BWE. The initial U.S. negotiating 

position on the IMO ballast water 

discharge standard in 2004 is beyond 

the scope of this rulemaking; however, 

as stated in section V.A.1 of the 

preamble, it is our intention to work 

toward a more stringent standard. 

One commenter stated that 

information about the resulting damages 

avoided by implementing alternatives 3 

through 5 needs to be presented in the 

DPEIS on page H–10, paragraph 3, so 

that all alternatives can be compared on 

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equal footing. The NPRM RA (available 

on the docket for this rule) presents the 

total potential benefit from different 

proposed BWDS alternatives in chapter 

5 (table 5.12). The values presented in 

this table enable the comparison of the 

benefits of alternatives 2, 3, and 4. 

One commenter stated that the 

production and retrofitting of any heavy 

equipment onboard the world fleet 

would add not only cost, but also 

additional energy requirements and 

emissions. One commenter stated that 

in addition to the economic burden 

imposed by the additional power and 

gear requirements to operate BWMS, 

there will also be an associated increase 

in air pollutants and greenhouse gas 

emissions from additional fuel 

combustion. 

We expect that our environmental 

analysis of individual BWMS, as part of 

the approval process, would indicate 

whether that specific BWMS might 

increase vessel energy requirements and 

emissions, which would be taken into 

consideration before U.S. type approval 

is granted. 

One commenter stated that the DPEIS 

fails to provide a set of criteria or rubric 

for how the Coast Guard compared each 

of the alternatives in order to arrive at 

alternative 2 as the preferred alternative. 

The commenter also stated that there is 

a lack of references for key facts and 

insufficient cost data to support the 

argument that alternatives 3 and 4 are 

prohibitively expensive. 

The Coast Guard acknowledges the 

comment that the analyses included in 

the DPEIS (and NPRM) did not present 

a detailed cost analysis of more 

stringent BWDS. There are very limited 

cost data available for technologies that 

would meet more stringent standards. 

The Coast Guard used the best 

information available at the time of the 

analysis to evaluate alternatives 3 and 4. 

Therefore, we have determined that 

additional analysis is needed, and have 

already begun its development. As 

noted in this preamble in V.A. Summary 

of Changes from the NPRM, as we 

complete this work, the Coast Guard has 

decided to move forward with the 

proposed phase-one standard (or 

alternative 2) with this final rule, which 

does not include a more stringent 

BWDS. 

One commenter asked whether the 

costs that appear in Appendix H of the 

DPEIS are based on installation of 

treatment systems on U.S.-flagged 

vessels only or if it includes all vessels 

that will be discharging in the waters of 

the United States. The costs of 

installation that the Coast Guard 

presented in Appendix H—table H–3, 

‘‘Costs to the U.S. vessels to comply 

with IMO BWM Convention 

(Alternative 2) BWD Standard ($Mil)’’— 

are for U.S. vessels only. Appendix C of 

the NPRM RA (available in the docket), 

presents cost estimates for the foreignflagged vessels. 

One commenter stated that the 

argument that capital and operation 

costs will double and quadruple for 

alternative 3 and alternative 4, 

respectively, is not accurate based on 

data presented in Lloyd’s Register 

(2008) and Dobroski et al. (2009). A 

second commenter requested that the 

Coast Guard provide some basis for why 

it believes that the costs for alternative 

3 would double those of alternative 2 

and that the costs for alternative 4 

would quadruple those for alternative 2. 

This commenter echoed the belief that 

cost data presented in recent reports by 

Lloyd’s Register (2008) and the CSLC 

(Dobroski et al. 2009) do not agree with 

Coast Guard estimates. The commenter 

added that up-to-date facts and figures 

are needed to clearly demonstrate that 

such an increase in costs will be 

observed in the event that these 

alternatives are implemented. 

As the Coast Guard noted previously 

in our discussion of the comments 

received on the NPRM RA, cost 

estimates presented in Lloyd’s Report 

and in the CLSC ‘‘Assessment of 

Efficacy, Availability and 

Environmental Impacts of Ballast Water 

Treatment Systems for Use in California 

Waters’’ (Dobroski, Scianni, Gehringer 

and Falkner, 2009) are related to 

systems that meet the current IMO 

discharge standard only and are 

consistent with the Coast Guard’s cost 

estimates ($258,000 to $2,525,000) and 

the Congressional Budget Office 

($300,000 to $1,000,000). 

Nevertheless, the Coast Guard 

acknowledges that the NPRM, DPEIS, 

and the NPRM RA did not present a 

detailed cost analysis of more stringent 

standards. There are very limited cost 

data available for technologies that 

would meet more stringent standards. 

Therefore, the Coast Guard has 

determined that additional analysis is 

needed, and has already begun its 

development. Noted in preamble section 

V.A. Summary of Changes from the 

NPRM, as we complete this work, the 

Coast Guard has decided to move 

forward with the proposed phase-one 

standard (or alternative 2) with this final 

rule, which does not include a more 

stringent standard. 

One commenter requested that 

sources and dates be provided for the 

cost estimate data for installation and 

operation of the BWMS. One commenter 

requested the Coast Guard provide a 

source for the estimate that BWMS cost 

two to four times the cost of using midocean BWE. 

In Chapter 3 of the NPRM RA 

(available on the docket), the Coast 

Guard presented the data sources and 

timeframe used for the cost data. In 

Chapter 1 of the NPRM RA, the Coast 

Guard also mentioned the timeframe 

used for the estimates. The Coast 

Guard’s cost estimates in the NPRM and 

DPEIS relied on manufacturer-provided 

data. Manufacturers supplied costs for 

equipment and installation. Data 

collection started in 2005/2006 and 

costs were updated in 2007/2008. 

The Coast Guard’s estimates are 

consistent with other notable cost 

estimates such as those made by Lloyds’ 

Register (2008) ($145,000 to $2,000,000) 

and the Congressional Budget Office 

($300,000 to $1,000,000). The Coast 

Guard is continuously monitoring 

BWMS technologies for new 

developments and changes in costs. 

Section 6.3 and Appendix B of the 

NPRM RA provided a comparison of 

BWDS and BWE. The BWE cost was 

based on the framework used in the 

2004 BWM RA adjusted for recently 

collected NBIC data. We did not find the 

BWMS cost to be two to four times the 

cost of using mid-ocean BWE. We 

estimated the annualized costs for BWE 

to be less than .01 percent of the 

annualized costs of the phase-one 

standard. 

One commenter asked whether the 

conclusions presented in page H–7, 

paragraph 1 of the DPEIS still hold, 

given the recent economic downturn, 

and if there is any evidence to show that 

costs won’t be passed on to consumers. 

The Coast Guard did not analyze the 

impact of the recent economic 

downturn and the potential impact on 

the consumers. We did include a 

discussion on the uncertainties related 

to the cost estimates (NPRM RA, section 

3.6) and compared the costs of 

implementing Alternative 2 for BWDS 

(the alternative proposed in the NPRM) 

to shipping revenues and consumer 

retail prices for goods typically 

transported by vessels. We compared 

amortized installation costs to long-term 

charter rates (NPRM RA, section 4.5). 

The NPRM costs typically represent less 

than one percent of charter rates 

suggesting reduced impact on 

consumers. Costs to the consumer are 

further reduced because maritime 

transportation costs generally represent 

only one to two percent of the retail cost 

of goods. 

One commenter stated that the 

calculations to determine the number of 

invasions and amount of economic 

damage that would be reduced seem 

excessively convoluted and 

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inappropriate. The commenter also 

stated that the shipping-based invasion 

rates of invertebrates are projected into 

the future and are used to estimate the 

number of plant and fish invasions 

based on historical relationships 

between the three groups (even though 

there is no mention whether the 

relationships used take into account that 

the shipping-based invertebrate 

invasions are only a portion of the 

overall invertebrate invasions). The 

commenter added that these values are 

then adjusted back to account for only 

those invasions that are attributable to 

ballast water (even though this type of 

data involve a great deal of uncertainty, 

see Fofonoff et al., 2003) and that these 

values are then adjusted again to 

account for those invasions that cause 

economic harm. 

The Coast Guard acknowledges that 

the calculations to determine the 

number of invasions and economic 

damage that could be reduced by the 

proposed BWMS are complicated and 

subject to uncertainty. However, the 

Coast Guard believes that each of the 

steps is appropriate and necessary in 

order to narrow the number of invasions 

considered to only those that could be 

reduced specifically by BWMS. In 

addition, as these calculations were 

used to develop monetized estimates of 

benefits, we also needed to limit the 

analysis to those invasions that cause 

economic harm. 

One commenter asked what damages 

are likely to result from the 

implementation of alternatives 3 

through 5. In the NPRM RA (available 

on the docket), chapter 5 (table 5.12), 

the Coast Guard presents the total 

potential benefit from different 

proposed BWDS alternatives. The 

values presented in this table enable the 

comparison of the benefits of 

alternatives 2, 3, and 4. As stated in the 

DPEIS, it is assumed that the 

implementation of alternatives 2 

through 5 would not have additional 

adverse impacts on environmental and 

socioeconomic resources. Based on this 

assumption, the alternatives considered 

in the DPEIS differ only in their 

potential to reduce the probability of 

NIS threatening the ecological stability 

of infested waters or other resources 

dependent on such waters. The impact 

of implementing the BWDS defined 

under each alternative is determined by 

the respective reduction in the number 

of living organisms that are introduced. 

One commenter stated their concern 

about the completeness and accuracy of 

the information used in the DPEIS. The 

commenter added that the economic 

and environmental benefits of effective 

controls on ballast water discharge are 

grossly underestimated in chapters 3 

and 4 of the DPEIS. The commenter 

recommended that, if it is determined 

that additional work on the cost/benefit 

analysis is warranted, the Coast Guard 

should work closely with the States to 

gather the latest economic information 

on the actual and potential impacts NIS 

have on our water resources. 

The Coast Guard used the best data 

available at the time of the research; we 

reviewed peer-reviewed papers on 

invasion-related costs and benefits. 

These papers included some local 

(regional) data as well as national. The 

Coast Guard will continue to monitor 

peer-reviewed literature to incorporate 

new studies and estimates as they 

become available. 

One commenter stated that it was 

unclear in the DPEIS whether the cost 

associated with failure to achieve the 

objectives (e.g., habitat loss or 

modification, lost productivity of 

commercially viable native species, lost 

value of existing mitigation/restoration 

actions) was addressed for each of the 

alternatives. The commenter further 

states that the true cost of implementing 

an alternative should include the cost to 

the environment associated with NIS 

introductions under that alternative. 

The Coast Guard acknowledges that 

some environmental costs of invasions 

cannot be easily monetized. The Coast 

Guard used the best data available at the 

time of the research; we reviewed peer 

reviewed papers on invasion-related 

costs and benefits. In addition to the 

DPEIS, chapter 5 of the NPRM RA 

presents an estimate of the value of the 

economic harm caused by invasive NIS. 

We calculated these values in order to 

estimate the range of monetary benefits 

from the proposed rule to compare 

against cost estimates. 

One commenter stated that the 

benefits presented for alternative 2 

should also be presented for alternatives 

3 through 5. In the NPRM RA (available 

on the docket), chapter 5 (table 5.12), 

the Coast Guard presents the total 

potential benefits from different 

proposed alternatives. The values 

presented in this table enable the 

comparison of the benefits of 

alternatives 2, 3, and 4. In addition, the 

Coast Guard is now further investigating 

costs and benefits of more stringent 

standards. 

One commenter requested that the 3 

and 7 percent discount rates be 

explained in the DPEIS, as they are not 

commonly understood by individuals 

outside of finance. The Coast Guard 

followed the guidelines from OMB 

Circular A–4, which provides guidance 

to Federal agencies on the development 

of regulatory analysis as required under 

paragraph 6(a)(3)(c) of Executive Order 

12866, ‘‘Regulatory Planning and 

Review,’’ also the Regulatory Right-toKnow Act, and a variety of related 

authorities. According to OMB Circular 

A–4 (page 34), the RA should provide 

costs and benefits estimates using both 

3 and 7 percent discount rates. For more 

detailed explanation on the use of 

discount rates for regulatory analysis see 

OMB Circular A–4, pages 31 to 34. 

One commenter stated that the 

proposed rule and the DPEIS are 

deficient in providing accurate costs, 

and thus justification on a cost/benefit 

basis for implementation of the rule as 

proposed. The commenter also states 

that NPRM provides much information 

relative to the compliance costs for U.S.- 

flagged vessels but little more than a 

passing comment on compliance costs 

for foreign-flagged vessels (74 FR 

22643). 

The Coast Guard estimated cost 

impacts for foreign-flagged vessels in 

the NPRM RA (see Appendix C) and the 

final rule RA (see Appendix D). As 

previously discussed, we have also 

made the phase-one standard as 

consistent as possible with the IMO 

BWM Convention’s discharge standard. 

We assume foreign government 

administrations that adopt the IMO 

BWM Convention and the foreignflagged vessels they administer to be 

responsible for the implementation and 

compliance with the IMO BWM 

Convention once it comes into force. We 

assume these foreign government 

administrations and the foreign-flagged 

vessels they administer to be 

responsible for the costs associated with 

the implementation and compliance of 

the IMO BWM Convention. Therefore, 

in the analyses of the NPRM and this 

final rule, our primary cost estimate of 

the phase-one standard rule includes 

costs to U.S. flagged-vessels only. This 

is similar to Coast Guard’s assessment of 

impacts from regulations related to 

other international conventions, which 

take into account the costs incurred by 

U.S. vessels and owners and operators 

only (e.g., regulations related to The 

Standards of Training, Certification & 

Watchkeeping Convention (STCW) and 

regulations related to the International 

Convention for the Prevention of 

Pollution From Ships (MARPOL)). 

Nonetheless, the Coast Guard 

estimated the foreign vessel costs of this 

rule in order to illustrate the potential 

economic impact to foreign-flagged 

vessel owners operating in the waters of 

the United States. The detailed 

description of the economic impact on 

foreign vessels is presented in the 

NPRM RA (Appendix C), available on 

the docket. 

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One commenter suggested adding a 

column to the DPEIS’ ‘‘Estimated 

Number of Ballast Water Invasions that 

Cause Harm’’ table for diseases, viruses, 

etc., and an ‘‘Other’’ column for fish, 

plants, and invertebrates. The 

commenter cited VHS in particular, 

stating that while it is uncertain that 

ballast water was the mechanism for 

introduction of VHS, it is the likely 

cause, and that State and Federal agency 

costs to address VHS infection will 

continue to rise as the disease spreads 

throughout the Great Lakes and inland 

waters. The Coast Guard disagrees with 

this comment and believes there is 

sufficient information in the FPEIS as it 

stands. 

One commenter stated that while the 

proposed rule uses the words 

‘‘introduction’’ and ‘‘spread’’ in relation 

to ballast water, the solution makes no 

distinction between these vastly 

different issues. The commenter said 

that the DPEIS fails to calculate the 

costs and benefits of BWMS regarding 

the introduction to or spread within an 

ecosystem separately which the 

commenter believes is counter to the 

conclusions of the Great Lakes Regional 

Collaboration that the most appropriate 

response to NIS was to require BWMS 

on ocean-going vessels and Best 

Management Practices on Great Lakes 

vessels. The Coast Guard disagrees with 

this comment, as we believe the BWDS 

must be used to combat both the 

introduction and spread of NIS in 

waters of the United States. 

Modal Shift Comments on the DPEIS 

Two commenters stated that it is 

important to consider the potentially 

devastating environmental impacts of a 

large-scale modal shift in their region, 

which already has a high volume of 

truck traffic to facilitate border trade 

and the North American Free Trade 

Agreement corridor. Another 

commenter raised the possibility that 

the cost of retrofitting vessels for BWMS 

could result in a modal shift of cargoes 

to surface transportation, resulting in 

the ‘‘unintended consequences’’ of less 

carbon-efficient transportation, 

increased air emissions, more severely 

crowded roadways and increased 

infrastructure costs. 

As previously discussed in the NPRM 

RA, we compared the costs of 

implementing the BWDS to shipping 

revenues and consumer retail prices for 

good typically transported by vessels. 

We have also compared amortized 

installation costs to long-term charter 

rates. These costs typically represent 

less than one percent of long-term 

charter rates. Although the overall cost 

of implementing this rule is significant, 

the cost will have minimal impact on 

the costs of goods and services. In 

addition, there are only a few 

substitutes for the maritime 

transportation of goods from overseas 

and producers. The Coast Guard did not 

find information or data indicating that 

there will be large modal shifts. 

Phase-Two Comments 

Twenty commenters addressed the 

phase-two standard in one way or 

another. Additionally, nine commenters 

stated that the NPRM and DPEIS do not 

evaluate the phase-two standard and 

that they are incomplete without an 

assessment of the environmental 

impacts of this standard. One of these 

commenters also stated that the DPEIS 

should clarify that alternative 5 

(elimination of all living organisms 

larger than 0.1 micrometer) does not 

correspond to the proposed phase-two 

standard. 

As we discussed in this preamble in 

V.A. Summary of Changes from the 

NPRM, the Coast Guard has removed 

the proposed phase-two standard from 

this final rule. However, after additional 

analysis and research we intend to issue 

a rule addressing the proposed phasetwo standard or any standard higher 

than phase-one, and will keep these 

comments in mind as we develop that 

rule. 

One commenter recommended that 

the standard 1,000 times more stringent 

than phase one be included in the PEIS, 

as well as a zero-discharge alternative 

that also restricts ocean vessel access to 

the Great Lakes. The Coast Guard partly 

agrees with this comment. We 

acknowledge that the PEIS must include 

the proposed phase-two standard. We 

have already begun this process, and 

expect to issue a revised PEIS when we 

address the proposed phase-two 

standard or any standard higher than 

phase-one. However, the PEIS evaluates 

a BWDS that applies to the entire 

United States, and not by individual 

geographic areas. 

8. Beyond the Scope 

We received many comments that 

were beyond the scope of this rule. 

Below, we summarize these comments, 

and respond to those that though 

beyond the scope, do have some 

relevance to this rule. 

Two commenters encouraged the 

United States to ratify the IMO BWM 

Convention. One commenter 

recommended conducting a 

multinational risk assessment of vesselmediated invasions of Arctic areas. One 

commenter suggested methods of 

funding the eradication of existing 

aquatic nuisance species. Another 

commenter expressed concerns about 

the Coast Guard directing sufficient 

funding to the implementation of the 

regulations. One commenter 

recommended that the Coast Guard 

revise 33 CFR 151.2050(c) to more 

accurately reflect when local, State, or 

Federal regulations apply to sediment 

disposal, such as under controlled 

arrangements at port or drydock. These 

comments are beyond the scope of this 

rule. 

One commenter suggested the Coast 

Guard enter into a Memorandum of 

Understanding with the Department of 

the Interior to address invasive species 

concerns. 

The Coast Guard strives to work 

closely and collaboratively with all 

Federal agencies on matters of mutual 

interest. More formal arrangements will 

be pursued when necessary. 

One commenter recommended that 

STEP permit the enrollment of vessel 

fleets as an incentive for participation. 

Another commenter recommended 

providing incentives to companies that 

could lead to the development of 

freshwater BWDS. 

The STEP processes and development 

of ballast water treatment technologies 

are beyond the scope of this rule. The 

comments will be forwarded to the 

STEP managers and appropriate Coast 

Guard office for consideration. 

One commenter questioned whether 

treated ballast water would be subject to 

the EPA VGP or be considered an 

industrial discharge and therefore 

require a separate NPDES permit. 

We consulted EPA and confirmed that 

ballast water treated and discharged in 

waters of the United States, as that term 

is defined in the Clean Water Act, by a 

vessel under this regulation would be 

subject to the EPA VGP. 

One commenter stated that a rapid 

response program to mitigate 

infestations of invasive NIS should be a 

guiding principle of the regulations. 

Rapid response to invasions is beyond 

the scope of the rule, which focuses on 

preventing the introduction of new 

invasions. However, as a member of the 

Aquatic Nuisance Species Task Force, 

the Coast Guard works with other 

Federal and State agencies to improve 

the nation’s invasive species response 

capabilities. 

Fifty-four commenters urged the Coast 

Guard to work closely with the EPA, the 

States, Canada and the IMO in 

developing a coordinated Federal ballast 

water program. One commenter urged 

the administration to consider NISA as 

the sole standard for ballast water 

discharge by ocean-going vessels. 

Conversely, one commenter asked that 

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6This 10-year period of analysis was used to 

estimate costs and benefits in the NPRM. See the 

NPRM RA and the final rule RA for additional 

discussion and detail on costs and benefits over 

various periods of time. 

7Foreign government administrations signing on 

to the IMO Convention and the foreign-flagged 

vessels they administer will be responsible for 

compliance with the IMO Convention once it comes 

into force. The final rule RA presents supplemental 

cost estimates for foreign-flagged vessels projected 

to call in waters of the United States. 

8Cost and benefit estimates discussed in this final 

rule are based on a 7 percent discount rate. See the 

final rule RA in the docket for additional discussion 

and estimates using other discount rates. 

ballast water regulation of vessels in the 

offshore energy services be left to States. 

These comments are beyond the scope 

of this rule, however, we note that we 

have worked and will continue to work 

closely with Federal, international, and 

State partners to develop a consistent, 

coordinated ballast water program. 

Four commenters provided 

suggestions on implementation and 

enforcement of the BWM program and 

information sharing among 

governmental agencies and the public. 

While they did not address any 

proposals from the NPRM, these 

comments had merit and will be kept in 

mind as the Coast Guard continues to 

refine its BWM program. 

Seven commenters urged the removal 

of the exemption for crude oil tankers 

engaged in coastwise trade under NISA. 

While we appreciate the commenters’ 

intent, the Coast Guard lacks the 

authority for the requested action, 

therefore this request is outside of the 

scope of this rule. 16 U.S.C. 

4711(c)(2)(L). However, crude oil 

tankers engaged in coastwise trade will 

be subject to all other applicable U.S. 

laws, such as the CWA, which does not 

contain an exemption. 

VI. Incorporation by Reference 

The Director of the Federal Register 

has approved the material in 46 CFR 

162.060–5 for incorporation by 

reference under 5 U.S.C. 552 and 1 CFR 

part 51. You may inspect this material 

at U.S. Coast Guard Headquarters where 

indicated under ADDRESSES. Copies of 

the material are available from the 

sources listed in 46 CFR 162.060–5. 

VII. Regulatory Analyses 

We developed this final rule after 

considering numerous statutes and 

executive orders related to rulemaking. 

Below we summarize our analyses 

based on 14 of these statutes or 

executive orders. 

A. Regulatory Planning and Review 

This final rule is an economically 

significant regulatory action under 

section 3(f) of Executive Order 12866, 

Regulatory Planning and Review, as 

supplemented by Executive Order 

13563, Improving Regulation and 

Regulatory Review. OMB has reviewed 

it under those Orders. It requires an 

assessment of potential costs and 

benefits under section 6(a)(3) of 

Executive Order 12866. We have revised 

the estimates from the NPRM 

Preliminary Regulatory Analysis 

(‘‘NPRM RA’’) to reflect the changes 

described in this preamble under V. 

Discussion of Comments and Changes. 

A final rule Regulatory Analysis (‘‘Final 

Rule RA’’) with revised impact 

estimates of the phase-one BWDS is 

available in the docket as indicated 

under ADDRESSES. A summary of the 

findings follows. 

The final rule RA provides an 

evaluation of the economic impacts 

associated with this final rule, which is 

the implementation of the phase-one 

BWDS. 

Table 1 provides a comparison of 

regulatory impacts resulting from 

changes between the NPRM and the 

final rule. 

TABLE 1—COMPARISON OF REGULATORY IMPACTS RESULTING FROM CHANGES BETWEEN THE NPRM AND FINAL RULE

Category NPRM Final rule 

Applicability ......................................................... All vessels discharging ballast water into U.S. 

waters.

Oceangoing vessels and some coastwise vessels (>1,600 GT) discharging ballast water 

in U.S. waters. 

Compliance Start Date ....................................... Beginning 2012 ................................................ Revised, beginning 2013. 

Number of BWMS Installations on Vessels (10- 

year period of analysis).

4,758 ................................................................ 3,046. 

Costs ($ millions,7 percent discount rate) .......... $167 (annualized) ............................................

$1,176 (10-year). 

$92 (annualized). 

$649 (10-year). 

Benefits ($ millions,7 percent discount rate) ...... $165–$282 (annualized) ..................................

$1,161–$1,977 (10-year). 

$141–$240 (annualized) 

$989–$1,684 (10-year). 

Note: The Regulatory Analysis in the docket for this rulemaking presents additional discussion of calculations and ranges for costs and 

benefits. 

Based on data from the Marine 

Information for Safety and Law 

Enforcement system and the NBIC, we 

estimate that approximately 3,046 

existing and new U.S. vessels will 

potentially be required to install and 

operate approved BWMS over a 10-year 

period of analysis.6 As originally 

discussed in the NPRM, we consider the 

phase-one BWDS regulatory costs of this 

rule to involve U.S. vessels, as foreignflagged vessels are expected to comply 

pursuant to the IMO BWM Convention, 

which is the phase-one BWDS.7

Costs 

The primary cost drivers of this rule 

are installation related costs. We 

estimate operation and maintenance 

costs to be substantially less. Costs vary 

by year based on the implementation 

schedule of this rule. Over a 10-year 

period of analysis, the total discounted 

present value cost for U.S. vessels is 

approximately $649 million at a 7 

percent discount rate (rounded primary 

estimate).8 We estimate the annualized 

cost over the same period of analysis to 

be about $92 million at a 7 percent 

discount rate. Our cost assessment 

includes existing and new vessels. 

Benefits 

NIS introductions contribute to the 

loss of marine biodiversity and have 

significant social, economic, and 

environmental impacts. Avoided costs 

associated with future initial NIS 

invasions and secondary spread of 

invasions (which may result from the 

initial invasion) represent the primary 

benefits of BWM. Economic costs 

(damages) from invasions of NIS range 

in the billions of dollars annually. The 

most extensive review to date on the 

economic costs of introduced species in 

the United States includes estimates for 

many types of NIS and is summarized 

in Table 2. 

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Federal Register / Vol. 77, No. 57 / Friday, March 23, 2012 / Rules and Regulations 17301 

9Estimates discussed in this final rule are based 

on a 7 percent discount rate. See the final rule RA 

in the docket for additional discussion and 

estimates using other discount rates. 

TABLE 2—ESTIMATED ANNUAL COSTS

ASSOCIATED WITH AQUATIC NIS INTRODUCTION IN THE UNITED STATES

[$ in 2007] 

Species Costs 

Fish ..................................... $5.7 billion. 

Zebra and Quagga Mussels $1.06 billion. 

Asiatic Clam ........................ $1.06 billion. 

Aquatic Weeds ................... $117 million. 

Green Crab ......................... $47 million. 

Source: Pimentel, D. et al., 2005. ‘‘Update 

on the environmental and economic costs associated with alien-invasive species in the 

United States,’’ Ecological Economics. 

52:273–288. 

Though a particular invasion may 

have small direct economic impacts, the 

accumulation of these events may cost 

in the billions of dollars every year. 

Only a few invasions to date have led 

to quantified cost estimates in the 

billions of dollars per year. 

The benefits of BWDS are difficult to 

quantify because of the complexity of 

ecosystems and a lack of information to 

estimate the probabilities of invasions 

based on prescribed levels of organisms 

in ballast water. However, evaluation of 

costs associated with previous invasions 

(described previously) allows a 

comparison of the costs of BWDS versus 

the costs of avoided damages. 

The primary benefit of this rule comes 

from a reduction in the concentration of 

all organisms, leading to lower numbers 

of these organisms being introduced per 

discharge. This further reduces the 

number of new invasions because the 

likelihood of establishment decreases 

with reduced numbers of organisms 

introduced per discharge. 

The quantified benefits have 

decreased between the NPRM and the 

final rule due to the longer phase-in 

period (see Table 1 this section). We use 

the same benefits model for the final 

rule as we did for the NPRM. This 

model quantifies benefits resulting from 

the reduction in ‘‘initial invasions’’ from 

vessels engaged in ocean-going trade. 

We have not found complete data or 

identified appropriate models to 

quantify the possible benefits associated 

with reducing the secondary spread of 

invasions. Therefore, we do not expect 

the exemption of inland vessels to 

reduce the estimate of quantified 

benefits given data and modeling 

limitations. See the Benefits chapter of 

the final rule RA for more discussion on 

the data and modeling framework used 

for this rulemaking. 

We calculate potential benefits of the 

phase-one BWDS by estimating the 

number of initial invasions reduced and 

the range of economic damage avoided. 

The FPEIS estimates the reduction in 

the mean rate of successful 

introductions for the phase-one 

standard. In comparison with the 

existing practice of BWE, the proposed 

phase-one BWDS is between 37 percent 

and 63 percent more effective in 

preventing invasions when fully 

implemented (see the FPEIS for further 

details on effectiveness). We use these 

estimates of the reduction in the rate of 

invasions to estimate the economic costs 

avoided (or benefits) as a result of a 

BWDS. 

Over a 10-year period of analysis, we 

estimate the total discounted present 

value benefits of the phase-one BWDS to 

be $0.989 billion to $1.684 billion 

(rounded primary estimate).9 We 

estimate the annualized benefits over 

the same period of analysis to be $141 

million to $240 million per year. 

As previously discussed, the 

annualized cost for domestic vessels 

over the period of analysis for the 

phase-one BWDS is estimated at about 

$92 million. Thus, quantified average 

benefits exceed quantified average costs 

for the phase-one BWDS. We also expect 

quantified benefits to increase as 

technology is developed to achieve 

more stringent discharge standards than 

the phase-one BWDS. 

B. Small Entities 

Under the Regulatory Flexibility Act 

(5 U.S.C. 601–612), we have considered 

whether this final rule would have a 

significant economic impact on a 

substantial number of small entities. 

The term ‘‘small entities’’ comprises 

small businesses, not-for-profit 

organizations that are independently 

owned and operated and are not 

dominant in their fields, and 

governmental jurisdictions with 

populations of less than 50,000. 

A Final Regulatory Flexibility 

Analysis discussing the impact of this 

final rule on small entities is available 

in the docket where indicated under 

ADDRESSES. 

Based on available data, we estimate 

that about 29 percent of entities affected 

by the final rule requirements are small 

under the Regulatory Flexibility Act and 

the SBA size standards (compared to the 

57 percent of entities affected by the 

NPRM provisions). This is due to the 

changes in the applicability (detailed 

explanation of applicability changes on 

section V.B.3 of this final rule). Based 

on our assessment of the impacts from 

the phase-one BWDS, we determined 

that small entities would incur a 

significant economic impact (more than 

1 percent impact on revenue) during 

installation. After installation, however, 

we found most small businesses would 

not incur a significant economic impact 

from annual recurring operating costs. 

We have determined that this final rule 

will have a significant economic impact 

on a substantial number of small 

entities. 

C. Assistance for Small Entities 

Under section 213(a) of the Small 

Business Regulatory Enforcement 

Fairness Act of 1996 (Pub. L. 104–121), 

we want to assist small entities in 

understanding the rule so that they can 

better evaluate its effects on them and 

participate in the rulemaking. If the rule 

would affect your small business, 

organization, or governmental 

jurisdiction and you have questions 

concerning its provisions or options for 

compliance, please call or email Mr. 

John Morris, Project Manager, U.S. Coast 

Guard, telephone 202–372–1433, email 

John.C.Morris@uscg.mil. The Coast 

Guard will not retaliate against small 

entities that question or complain about 

this final rule or any policy or action of 

the Coast Guard. 

Small businesses may send comments 

on the actions of Federal employees 

who enforce, or otherwise determine 

compliance with, Federal regulations to 

the Small Business and Agriculture 

Regulatory Enforcement Ombudsman 

and the Regional Small Business 

Regulatory Fairness Boards. The 

Ombudsman evaluates these actions 

annually and rates each agency’s 

responsiveness to small business. If you 

wish to comment on actions by 

employees of the Coast Guard, call 1– 

888–REG–FAIR (1–888–734–3247). 

D. Collection of Information 

This final rule calls for new collection 

of information under the Paperwork 

Reduction Act (PRA) of 1995 (44 U.S.C. 

3501–3520). As defined in 5 CFR 

1320.3(c), ‘‘collection of information’’ 

comprises reporting, recordkeeping, 

monitoring, posting, labeling, and other, 

similar actions. The title and 

description of the information 

collections, a description of those who 

must collect the information, and an 

estimate of the total annual burden 

follow. The estimate covers the time for 

reviewing instructions, searching 

existing sources of data, gathering and 

maintaining the data needed, and 

completing and reviewing the 

collection. This new collection of 

information is due to the final rule 

provision that allows vessel owners and 

operators to request a compliance 

extension. 

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10Sources: Lloyds Register Report, Ballast Water 

Treatment Technology-Current Status, September 

2008; and California State Lands Commission 

Report, Assessment of the Efficacy, Availability, 

and Environmental Impacts of Ballast Water 

Treatment Systems in California Waters, January 

2009. 

11This estimate is based on an existing collection 

of information (OMB Control Number 1625–0095) 

for requests of exemption and alternatives for Oil 

and Hazardous Materials Pollution and Safety 

Records Equivalent. 

12Wage rate obtained from Enclosure (2) to 

COMDTINST 7310.1M and validated based on the 

Bureau of Labor Statistics (BLS) subcategory 

Managers (Occupation Code 11–9199). 

13Wage rate obtained from Enclosure (2) to 

COMDTINST 7310.1M and validated based on the 

Bureau of Labor Statistics (BLS) subcategory Firstline Supervisor of office and Administrative 

Support Worker (Occupation Code 43–1011). 

In the NPRM, we found that there was 

no new collection of information for 

BWMS approval. This finding was 

based on the fact that our research 

indicated that there are 25–30 

manufacturers developing BWMS for 

installation onboard vessels.10 We 

expect to receive less than 10 BWMS 

approval requests per year. This figure 

is less than the threshold of 10 per 12- 

month period for collection of 

information reporting purposes under 

the PRA of 1995. 

The final rule’s new collection of 

information is a result of public 

comments received in the NPRM. In this 

final rule, we have included a 

paperwork provision to allow vessel 

owners and operators to request an 

extension of their compliance date if 

they cannot practicably comply with the 

compliance date otherwise applicable to 

their vessel. This extension provision 

will give flexibility to vessel owners and 

operators to comply with this rule. 

Summary information concerning all 

extension decisions, including the name 

of the vessel and vessel owner, the term 

of the extension, and the basis for the 

extension will be promptly posted on 

the U.S. Coast Guard Maritime 

Information Exchange Web site 

(CGMIX), currently located at [http:// 

cgmix.uscg.mil/Default.aspx]. 

The Coast Guard is amending the 

existing collection of information (OMB 

Control Number: 1625–0069) to add the 

above mentioned requests for extension. 

Title: Ballast Water Management for 

Vessels with Ballast Tanks Entering U.S. 

Waters. 

Summary of the Collection of 

Information: The information is needed 

to carry out the requirements of 16 

U.S.C. 4711 regarding the management 

of ballast water, to prevent the 

introduction and spread of aquatic 

nuisance species into U.S. waters. 

Respondents are owners and operators 

of certain vessels. The Coast Guard is 

amending the existing collection of 

information to include application for 

extensions as established in this final 

rule (33 CFR 151.1513 or 151.2036). 

Need for Information: The Coast 

Guard may grant an extension to the 

implementation schedule only in those 

cases where the master, owner, operator, 

agent, or person in charge of a vessel 

subject to this subpart can document 

that, despite all efforts, compliance with 

the requirements of this final rule is not 

possible, giving flexibility to vessel 

owners and operators to comply with 

this final rule. 

Extension evaluations will be on a 

per-vessel basis. Summary information 

concerning all extension decisions, 

including the name of the vessel and 

vessel owner, the term of the extension, 

and the basis for the extension will be 

promptly posted on the Internet. 

Extensions will be for no longer than the 

minimum time needed, as determined 

by the Coast Guard, for the vessel to 

comply with the requirements of 

§ 151.2030. 

Any extension request must be made 

no later than 12 months before the 

scheduled implementation date listed in 

§ 151.1512(b) of this subpart and 

submitted in writing to the 

Commandant (CG–522), U.S. Coast 

Guard Office of Operating and 

Environmental Standards, 2100 2nd St. 

SW., Stop 7126, Washington, DC 20593– 

7126. 

Proposed Use of Information: The 

Coast Guard will use the information 

provided in the extension request to 

evaluate whether to grant extension and 

for what period of time, and to keep 

records of vessels not meeting the 

established compliance date. The 

compliance extension provides 

additional time to determine how 

BWMS can be safely installed. An 

extension postpones installation costs 

for affected vessels. 

Description of the Respondents: 

Vessel owners and operators subject to 

the requirements of this final rule (see 

section V.A.3. Applicability). 

Number of Respondents: We do not 

have information on the potential 

number of vessel owners and operators 

that will take advantage of the 

compliance extension at this time. We 

estimate that between 10 and 30 percent 

of owners and operators of U.S. vessels 

affected by this final rule might request 

the extension based on preliminary 

information from industry, BWMS 

vendors and Coast Guard experts. We 

anticipate that extension requests will 

be based on issues related to safety and 

regulatory requirements of electrical 

equipment, vessel capacity to 

accommodate BWMS, vessel age, 

shipyard availability, and other reasons. 

At this time, we do not have the data to 

determine the potential number of 

requests for extension. We expect to 

obtain this information as we process 

the requests. We will revise this 

collection of information as we post the 

requests on the Web site or as needed. 

We estimate that owners and 

operators of approximately 146 to 438 

vessels (estimated total U.S. vessel 

affected by this rule is 1,459) might 

request compliance extensions for the 

reasons listed above. We estimate the 

total average number of vessels that will 

submit a request for extension to be 292. 

Frequency of the Response: Vessel 

owners and operators will submit a 

compliance extension request once. 

Burden of Response: We estimate that 

there could be an average of 292 existing 

vessels that could request an extension 

for installing a BWMS. The 292 is the 

total number of vessels estimated to 

request the extension. We estimate that 

the average time burden to prepare and 

submit a request is approximately 8 

hours (6 hours management and 2 hours 

clerical) 11 but burden may vary 

depending on type of vessel and reason 

for the extension request. The total 

average burden hours of vessels 

requesting an extension is 

approximately 2,336 hours (292 vessels 

× 8 hours for completing and submitting 

the extension documentation). The total 

burden cost is $141,328, calculated by 

(a) + (b): 

(a) Assuming someone at a management 

level (equivalent to GS–12 (out-ofgovernment rate)) prepares the submission to 

the Coast Guard, the applicable wage rate is 

$69/hour.12 Therefore, the total management 

cost for preparing the extension request is 

$69 × 6 hrs × 292 vessels = $120,888. 

(b) Assuming someone at the clerical level 

(equivalent to GS–5 (out-of-government rate)) 

files the copies, then the applicable wage rate 

is $35/hour.13 Therefore, the total 

management cost for preparing the extension 

request is $35 × 2hrs × 292 vessels = $20,440. 

The estimated cost per vessel is $484 

($141,328/292 vessels). The final cost of 

the final rule does not change given the 

amount of this paperwork requirement. 

Estimate of Total Annual Burden: At 

this time, we do not have information 

on how many vessel owners and 

operators will be requesting compliance 

extension per year. We expect to obtain 

this information as we process the 

requests. If we assume that 10 percent 

of the estimated owners of 292 vessels 

(see ‘‘Burden of Response,’’ above) will 

be applying to an extension every year, 

then the annual burden will be equal to 

approximately 234 hours (29.2 vessels × 

8 hrs or 10 percent of 2,336 hours). The 

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Federal Register / Vol. 77, No. 57 / Friday, March 23, 2012 / Rules and Regulations 17303 

14The value equivalent to $100,000,000 in 

calendar year 1995 adjusted for inflation to calendar 

year 2009 is about $140,800,000 (rounded to the 

nearest 100,000) using the Consumer Price Index for 

All Urban Consumers (CPI–U) as published by the 

Bureau of Labor Statistics, series CUUR0000SA0, 

http://www.bls.gov/data/top20.htm (accessed 4/26/ 

2010). Calendar year 2009 is the latest complete 

year for the annual CPI–U data series. This 

adjustment is based on recent Department of 

Transportation guidance on adjustments to the 

annual threshold (see http://regs.dot.gov/). 

annual cost will be approximately 

$14,132 (10 percent of $141,328). 

As required by the Paperwork 

Reduction Act of 1995 (44 U.S.C. 

3507(d)), we will submit a copy of this 

rule to the Office of Management and 

Budget (OMB) for its review of the 

collection of information. 

We ask for public comment on the 

proposed collection of information to 

help us determine how useful the 

information is; whether it can help us 

perform our functions better; whether it 

is readily available elsewhere; how 

accurate our estimate of the burden of 

collection is; how valid our methods for 

determining burden are; how we can 

improve the quality, usefulness, and 

clarity of the information; and how we 

can minimize the burden of collection. 

If you submit comments on the 

collection of information, submit them 

both to OMB and to the Docket 

Management Facility where indicated 

under ADDRESSES, by the date under 

DATES. 

You need not respond to a collection 

of information unless it displays a 

currently valid control number from 

OMB. Before the Coast Guard could 

enforce the collection of information 

requirements in this rule, OMB would 

need to approve the Coast Guard’s 

request to collect this information. 

E. Federalism 

A rule has implications for federalism 

under Executive Order 13132, 

Federalism, if it has a substantial direct 

effect on State or local governments and 

would either preempt State law or 

impose a substantial direct cost of 

compliance on them. 

We have analyzed this rule under that 

Order and have determined that it does 

not have implications for federalism. 

NANPCA, as amended by NISA, 

contains a ‘‘savings provision’’ that 

saves to the States their authority to 

‘‘adopt or enforce control measures for 

aquatic nuisance species, [and nothing 

in the Act would] diminish or affect the 

jurisdiction of any State over species of 

fish and wildlife.’’ 16 U.S.C. 4725. It 

also requires that ‘‘[a]ll actions taken by 

Federal agencies in implementing the 

provisions of [the Act] be consistent 

with all applicable Federal, State and 

local environmental laws.’’ Thus, the 

congressional mandate is clearly for a 

Federal-State cooperative regime in 

combating the introduction and spread 

of NIS into the waters of the United 

States from ships’ ballast water. This 

makes it unlikely that preemption, 

which would necessitate consultation 

with the States under Executive Order 

13132, would occur. 

We received a number of comments, 

from organizations, individuals, and 

States, on the issue of preemption. 

These comments are summarized and 

addressed in this preamble in V.B.6. 

Legal. 

F. Unfunded Mandates Reform Act 

The Unfunded Mandates Reform Act 

of 1995 (2 U.S.C. 1531–1538) requires 

Federal agencies to assess the effects of 

their discretionary regulatory actions. In 

particular, the Act addresses actions 

that may result in the expenditure by a 

State, local, or tribal government, in the 

aggregate or by the private sector, of 

$100,000,000 (adjusted for inflation 

with a base year of 1995) or more in any 

1 year (2 U.S.C. 1532). The Coast Guard 

currently uses an inflation-adjusted 

value of about $140.8 million in lieu of 

$100 million.14 The private sector will 

incur costs exceeding the $140.8 million 

threshold during the third and fourth 

years of the rule implementation period 

(see Regulatory Analysis in the docket 

for additional details). 

In accordance with 2 U.S.C. 

1532(a)(1), this rule generally would be 

promulgated under the authority of 46 

U.S.C. Chapter 45 and also under the 

authority of the statutes, Executive 

Orders, and delegations cited in the 

‘‘Authority’’ lines of the specific Code of 

Federal Regulations parts we propose to 

amend. We include the assessments and 

estimates that would be required by 2 

U.S.C. 1532(a)(2) through (a)(4) in the 

Regulatory Analysis report available in 

the docket as indicated under the 

ADDRESSES section of this preamble. 

G. Taking of Private Property 

This rule will not cause a taking of 

private property or otherwise have 

taking implications under Executive 

Order 12630, Governmental Actions and 

Interference with Constitutionally 

Protected Property Rights. 

H. Civil Justice Reform 

This rule meets applicable standards 

in sections 3(a) and 3(b)(2) of Executive 

Order 12988, Civil Justice Reform, to 

minimize litigation, eliminate 

ambiguity, and reduce burden. 

I. Protection of Children 

We have analyzed this rule under 

Executive Order 13045, Protection of 

Children from Environmental Health 

Risks and Safety Risks. Though this rule 

is economically significant, it does not 

create an environmental risk to health or 

risk to safety that may 

disproportionately affect children. 

J. Indian Tribal Governments 

This rule does not have tribal 

implications under Executive Order 

13175, Consultation and Coordination 

with Indian Tribal Governments, 

because it does not have a substantial 

direct effect on one or more Indian 

tribes, on the relationship between the 

Federal Government and Indian tribes, 

or on the distribution of power and 

responsibilities between the Federal 

Government and Indian tribes. 

K. Energy Effects 

We have analyzed this rule under 

Executive Order 13211, Actions 

Concerning Regulations That 

Significantly Affect Energy Supply, 

Distribution, or Use. We have 

determined that it is not a ‘‘significant 

energy action’’ under that order. Though 

it is a ‘‘significant regulatory action’’ 

under Executive Order 12866, it is not 

likely to have a significant adverse effect 

on the supply, distribution, or use of 

energy. The Administrator of the Office 

of Information and Regulatory Affairs 

has not designated it as a significant 

energy action. Therefore, it does not 

require a Statement of Energy Effects 

under Executive Order 13211. 

L. Technical Standards 

The National Technology Transfer 

and Advancement Act (15 U.S.C. 272 

note) directs agencies to use voluntary 

consensus standards in their regulatory 

activities unless the agency provides 

Congress, through OMB, with an 

explanation of why using these 

standards would be inconsistent with 

applicable law or otherwise impractical. 

Voluntary consensus standards are 

technical standards (e.g., specifications 

of materials, performance, design, or 

operation; test methods; sampling 

procedures; and related management 

systems practices) that are developed or 

adopted by voluntary consensus 

standards bodies. 

This rule uses a number of technical 

standards, all of which are voluntary 

consensus standards. These may be 

found in the technology approval 

program amendments to 46 CFR part 

162 and are listed below. 

The voluntary consensus standards 

used by this rule are: 

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17304 Federal Register / Vol. 77, No. 57 / Friday, March 23, 2012 / Rules and Regulations 

(1) International Electrotechnical 

Commission (IEC), 529, Degrees of 

Protection Provided by Enclosures, 

1989; 

(2) International Organization for 

Standardization (ISO) and the IEC, ISO/ 

IEC 17025, General Requirements for the 

Competence of Calibration and Testing 

Laboratories, 2005; and 

(4) Environmental Protection 

Agency’s Environmental Technology 

Verification (ETV) Program Generic 

Protocol for the Verification of Ballast 

Water Treatment Technologies. 

M. Environment 

We have analyzed this rule under 

Department of Homeland Security 

Management Directive 023–01 and 

Commandant Instruction M16475.lD, 

which guide the Coast Guard in 

complying with NEPA (42 U.S.C. 4321– 

4370f), and have concluded that this 

action may have a significant effect on 

the human environment. A Final 

Programmatic Environmental Impact 

Statement and Record of Decision are 

available in the docket where indicated 

under ADDRESSES, and include a 

summary of our actions to comply with 

NEPA. 

List of Subjects 

33 CFR Part 151 

Administrative practice and 

procedure, Ballast water management, 

Oil pollution, Penalties, Reporting and 

recordkeeping requirements, Water 

pollution control. 

46 CFR Part 162 

Ballast water management, Fire 

prevention, Incorporation by reference, 

Marine safety, Oil pollution, Reporting 

and recordkeeping requirements. 

For the reasons discussed in the 

preamble, the Coast Guard amends 33 

CFR part 151 and 46 CFR part 162 as 

follows: 

Title 33—Navigation and Navigable 

Waters 

CHAPTER I—COAST GUARD 

Subchapter O—Pollution 

PART 151—VESSELS CARRYING OIL, 

NOXIOUS LIQUID SUBSTANCES, 

GARBAGE, MUNICIPAL OR 

COMMERCIAL WASTE, AND BALLAST 

WATER 

Subpart C—Ballast Water Management 

for Control of Nonindigenous Species 

in the Great Lakes and Hudson River 

■ 1. The authority citation for subpart C 

continues to read as follows: 

Authority: 16 U.S.C. 4711; Department of 

Homeland Security Delegation No. 0170.1. 

■ 2. Revise § 151.1502 to read as 

follows: 

§ 151.1502 Applicability. 

This subpart applies to all nonrecreational vessels, U.S. and foreign, 

that are equipped with ballast tanks 

that, after operating on the waters 

beyond the Exclusive Economic Zone 

during any part of its voyage, enter the 

Snell Lock at Massena, New York, or 

navigates north of the George 

Washington Bridge on the Hudson 

River, regardless of other port calls in 

the United States or Canada during that 

voyage, except as expressly provided in 

33 CFR 151.2015(a). All vessels subject 

to this subpart are also required to 

comply with the applicable 

requirements of 33 CFR 151.2050, 

151.2060, and 151.2070. 

■ 3. In § 151.1504, add, in alphabetical 

order, definitions for the terms 

‘‘Alternate management system (AMS)’’, 

‘‘Ballast water management system 

(BWMS)’’, ‘‘Constructed’’, and ‘‘Waters 

of the United States’’ to read as follows: 

§ 151.1504 Definitions. 

* * * * * 

Alternate management system (AMS) 

means a ballast water management 

system approved by a foreign 

administration pursuant to the 

standards set forth in the International 

Maritime Organization’s International 

BWM Convention, and meeting all 

applicable requirements of U.S. law, 

and which is used in lieu of ballast 

water exchange. 

* * * * * 

Ballast water management system 

(BWMS) means any system which 

processes ballast water to kill, render 

harmless, or remove organisms. The 

BWMS includes all ballast water 

treatment equipment and all associated 

control and monitoring equipment. 

* * * * * 

Constructed in respect to a vessel 

means a stage of construction when— 

(1) The keel of a vessel is laid; 

(2) Construction identifiable with the 

specific vessel begins; 

(3) Assembly of the vessel has 

commenced and comprises at least 50 

tons or 1 percent of the estimated mass 

of all structural material, whichever is 

less; or 

(4) The vessel undergoes a major 

conversion. 

* * * * * 

Waters of the United States means 

waters subject to the jurisdiction of the 

United States as defined in 33 CFR 2.38, 

including the navigable waters of the 

United States. For 33 CFR part 151, 

subparts C and D, the navigable waters 

include the territorial sea as extended to 

12 nautical miles from the baseline, 

pursuant to Presidential Proclamation 

No. 5928 of December 27, 1988. 

* * * * * 

■ 4. Add new § 151.1505 to read as 

follows: 

§ 151.1505 Severability. 

If a court finds any portion of this 

subpart to have been promulgated 

without proper authority, the remainder 

of this subpart will remain in full effect. 

■ 5. In § 151.1510— 

■ a. Revise the section heading; b. 

Revise paragraphs (a)(1) and (a)(3) and 

add new paragraph (a)(4); c. Add new 

paragraph (d). 

The revisions and additions read as 

follows: 

§ 151.1510 Ballast water management 

requirements. 

(a) * * * 

(1) Carry out an exchange of ballast 

water on the waters beyond the U.S. 

Exclusive Economic Zone (EEZ), from 

an area more than 200 nautical miles 

from any shore, and in waters more than 

2,000 meters (6,560 feet, 1,093 fathoms) 

deep, such that, at the conclusion of the 

exchange, any tank from which ballast 

water will be discharged contains water 

with a minimum salinity level of 30 

parts per thousand, unless the vessel is 

required to employ an approved ballast 

water management system (BWMS) per 

the schedule in § 151.1512(b) of this 

subpart. This exchange must occur prior 

to entry into the Snell Lock at Massena, 

NY, or navigating on the Hudson River, 

north of the George Washington Bridge. 

An alternative management system 

(AMS) that meets the requirements of 33 

CFR 151.2026 may also be used, so long 

as it was installed on the vessel prior to 

the date that the vessel is required to 

comply with the ballast water discharge 

standard in accordance with 

§ 151.1512(b) of this subpart. If using an 

AMS, the master, owner, operator, 

agent, or person in charge of the vessel 

subject to this subpart may employ the 

AMS for no longer than 5 years from the 

date they would otherwise be required 

to comply with the ballast water 

discharge standard in accordance with 

§ 151.1512(b) of this subpart. 

* * * * * 

(3) Install and operate a BWMS that 

has been approved by the Coast Guard 

under 46 CFR part 162, in accordance 

with § 151.1512(b) of this subpart. 

Following installation of a BWMS, the 

master, owner, operator, agent, or 

person in charge of the vessel must 

maintain the BWMS in accordance with 

all manufacturer specifications. 

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(i) Requirements for approval of 

BWMS are found in 46 CFR part 

162.060. 

(ii) Requests for approval of BWMS 

must be submitted to the Commanding 

Officer (Marine Safety Center), U.S. 

Coast Guard Marine Safety Center, 2100 

2nd St. SW., Stop 7102, Washington, DC 

20593–7102, or by email to 

msc@uscg.mil. 

(4) Use only water from a U.S. public 

water system (PWS), as defined in 40 

CFR 141.2 and that meets the 

requirements of 40 CFR parts 141 and 

143, as ballast water. Vessels using 

water from a PWS as ballast must 

maintain a record of which PWS they 

received the water and a receipt, 

invoice, or other documentation from 

the PWS indicating that water came 

from that system. Furthermore, they 

must certify that they have met the 

conditions in paragraphs (a)(4)(i) or (ii) 

of this section, as applicable. Vessels 

using water from a PWS must use such 

water exclusively for all ballast water 

unless the usage is in accordance with 

§ 151.1515 of this subpart. Vessels using 

PWS water as ballast must have either— 

(i) Previously cleaned the ballast 

tanks (including removing all residual 

sediments) and not subsequently 

introduced ambient water; or 

(ii) Never introduced ambient water to 

those tanks and supply lines. 

* * * * * 

(d) Unless otherwise expressly 

provided for in this subpart, the master, 

owner, operator, agent, or person in 

charge of vessels employing a Coast 

Guard-approved BWMS must meet the 

applicable ballast water discharge 

standard, found in § 151.1511 of this 

subpart, at all times of ballast water 

discharge into the waters of the United 

States. 

■ 6. Add new § 151.1511 to read as 

follows: 

§ 151.1511 Ballast water discharge 

standard (BWDS). 

(a) Vessels employing a Coast Guardapproved ballast water management 

system (BWMS) must meet the 

following BWDS by the date in 

§ 151.1512(b) of this subpart: 

(1) For organisms greater than or 

equal to 50 micrometers in minimum 

dimension: discharge must include 

fewer than 10 living organisms per 

cubic meter of ballast water. 

(2) For organisms less than 50 

micrometers and greater than or equal to 

10 micrometers: discharge must include 

fewer than 10 living organisms per 

milliliter (mL) of ballast water. 

(3) Indicator microorganisms must not 

exceed: 

(i) For Toxicogenic Vibrio cholerae 

(serotypes O1 and O139): a 

concentration of less than 1 colony 

forming unit (cfu) per 100 mL. 

(ii) For Escherichia coli: a 

concentration of fewer than 250 cfu per 

100 mL. 

(iii) For intestinal enterococci: a 

concentration of fewer than 100 cfu per 

100 mL. 

(b) [Reserved] 

(c) The Coast Guard will conduct a 

practicability review as follows: 

(1) No later than January 1, 2016, the 

Coast Guard will publish the results of 

a practicability review to determine— 

(i) Whether technology to comply 

with a performance standard more 

stringent than that required by 

paragraph (a) of this section can be 

practicably implemented, in whole or in 

part, and, if so, the Coast Guard will 

schedule a rulemaking to implement the 

more stringent standard; and 

(ii) Whether testing protocols that can 

accurately measure efficacy of treatment 

against a performance standard more 

stringent than that required by 

paragraph (a) of this section can be 

practicably implemented. 

(2) If the Coast Guard determines on 

the basis of a practicability review 

conducted under paragraph (c)(1) of this 

section that technology to achieve a 

significant improvement in ballast water 

treatment efficacy could be practicably 

implemented, the Coast Guard will 

report this finding and will, no later 

than January 1, 2017, initiate a 

rulemaking that would establish 

performance standards and other 

requirements or conditions to ensure to 

the maximum extent practicable that 

aquatic nuisance species are not 

discharged into waters of the United 

States from vessels. If the Coast Guard 

subsequently finds that it is not able to 

meet this schedule, the Coast Guard will 

publish a notice in the Federal Register 

so informing the public, along with an 

explanation of the reason for the delay, 

and a revised schedule for rule making 

that shall be as expeditious as 

practicable. 

(3) When conducting the 

practicability review as required by 

paragraph (c)(1) of this section, the 

Coast Guard will consider— 

(i) The capability of any identified 

technology to achieve a more stringent 

ballast water discharge standard, in 

whole or in part; 

(ii) The effectiveness of any identified 

technology in the shipboard 

environment; 

(iii) The compatibility of any 

identified technology with vessel design 

and operation; 

(iv) The safety of any identified 

technology; 

(v) Whether the use of any identified 

technology may have an adverse impact 

on the environment; 

(vi) The cost of any identified 

technology; 

(vii) The economic impact of any 

identified technology, including the 

impact on shipping, small businesses, 

and other uses of the aquatic 

environment; 

(viii) The availability, accuracy, 

precision, and cost of methods and 

technologies for measuring the 

concentrations of organisms, treatment 

chemicals, or other pertinent parameters 

in treated ballast water as would be 

required under any alternative discharge 

standards; 

(ix) Any requirements for the 

management of ballast water included 

in the most current version of the U.S. 

Environmental Protection Agency’s 

Vessel General Permit and any 

documentation available from the EPA 

regarding the basis for these 

requirements; and 

(x) Any other factor that the Coast 

Guard considers appropriate that is 

related to the determination of whether 

identified technology is performable, 

practicable, and/or may possibly 

prevent the introduction and spread of 

non-indigenous aquatic invasive 

species. 

§ 151.1512 and 151.1514 [Redesignated as 

§§ 151.1514 and 151.1515] 

■ 7. Redesignate §§ 151.1512 and 

151.1514 as §§ 151.1514 and 151.1515, 

respectively. 

■ 8. Add a new § 151.1512 to read as 

follows: 

§ 151.1512 Implementation schedule for 

approved ballast water management 

methods. 

(a) In order to discharge ballast water 

into the waters of the United States, the 

master, owner, operator, agent, or 

person in charge of a vessel subject to 

§ 151.1510 of this subpart must either 

ensure that the ballast water meets the 

ballast water discharge standard as 

defined in § 151.1511(a), use an AMS as 

provided for under § 151.1510(a)(1) or 

ballast exclusively with water from a 

U.S. public water system, as described 

in § 151.1510(a)(4), according to the 

schedule in paragraph (b) of this 

section. 

(b) Implementation Schedule for the 

Ballast Water Management Discharge 

Standard for vessels using a Coast 

Guard approved BWMS to manage 

ballast water discharged to U.S. waters. 

After the dates listed in Table 

151.1512(b), vessels may use a USCGmstockstill on DSK4VPTVN1PROD with RULES4

17306 Federal Register / Vol. 77, No. 57 / Friday, March 23, 2012 / Rules and Regulations 

approved BWMS and comply with the 

discharge standard, or employ an 

approved alternative ballast water 

management method per 

§ 151.1510(a)(1) and (4). 

TABLE 151.1512(b)—IMPLEMENTATION SCHEDULE FOR BALLAST WATER MANAGEMENT DISCHARGE STANDARDS FOR

VESSELS USING COAST GUARD APPROVED BALLAST WATER MANAGEMENT SYSTEMS

Vessel’s ballast 

water capacity Date constructed Vessel’s compliance date 

New vessels ........................ All ....................................... On or after December 1, 

2013.

On delivery. 

Existing vessels ................... Less than 1500 m3 ............ Before December 1, 2013 First scheduled drydocking after January 1, 2016. 

1500–5000 m3 ................... Before December 1, 2013 First scheduled drydocking after January 1, 2014. 

Greater than 5000 m3 ....... Before December 1, 2013 First scheduled drydocking after January 1, 2016. 

■ 9. Add new § 151.1513 to read as 

follows: 

§ 151.1513 Extension of Compliance Date. 

The Coast Guard may grant an 

extension to the implementation 

schedule in § 151.1512(b) of this subpart 

only in those cases where the master, 

owner, operator, agent, or person in 

charge of a vessel subject to this subpart 

can document that, despite all efforts, 

compliance with the requirement under 

§ 151.1510 is not possible. Any 

extension request must be made no later 

than 12 months before the scheduled 

implementation date listed in 

§ 151.1512(b) of this subpart and 

submitted in writing to the 

Commandant (CG–522), U.S. Coast 

Guard Office of Operating and 

Environmental Standards, 2100 2nd St. 

SW., Stop 7126, Washington, DC 20593– 

7126. Summary information concerning 

all extension decisions, including the 

name of the vessel and vessel owner, the 

term of the extension, and the basis for 

the extension will be promptly posted 

on the Internet. Extensions will be for 

no longer than the minimum time 

needed, as determined by the Coast 

Guard, for the vessel to comply with the 

requirements of § 151.1510. 

■ 10. Revise newly redesignated 

§ 151.1515 as follows: 

§ 151.1515 Ballast water management 

alternatives under extraordinary conditions. 

(a) As long as ballast water exchange 

(BWE) remains an option under the 

schedule in § 151.1512(b) of this 

subpart, the master of any vessel subject 

to this subpart who uses BWE to meet 

the requirements of this subpart and, 

due to weather, equipment failure, or 

other extraordinary conditions, is 

unable to effect a BWE before entering 

the U.S. Exclusive Economic Zone, and 

intends to discharge ballast water into 

the waters of the United States, must 

request permission from the Captain of 

the Port (COTP) to exchange the vessel’s 

ballast water within an area agreed to by 

the COTP at the time of the request and 

then discharge the vessel’s ballast water 

within that designated area. 

(b) Once BWE is no longer an option 

under the schedule in § 151.1512(b) of 

this subpart, if the ballast water 

management system required by this 

subpart stops operating properly during 

a voyage or the vessel’s BWM method is 

unexpectedly unavailable, the master, 

owner, operator, agent, or person in 

charge of the vessel must ensure that the 

problem is reported to the COTP as soon 

as practicable. The vessel may continue 

to the next port of call, subject to the 

directions of the COTP or the Ninth 

District Commander, as provided by 33 

CFR part 160. 

■ 11. Revise § 151.1516(a) to read as 

follows: 

§ 151.1516 Compliance Monitoring. 

(a) The master of each vessel 

equipped with ballast tanks must 

provide, as detailed in § 151.2070 of this 

part, the following information, in 

written form, to the Captain of the Port 

(COTP): 

* * * * * 

■ 12. Revise subpart D of part 151 to 

read as follows: 

Subpart D—Ballast Water Management for 

Control of Nonindigenous Species in 

Waters of the United States 

Sec. 

151.2000 Purpose and scope. 

151.2005 Definitions. 

151.2010 Applicability. 

151.2013 Severability. 

151.2015 Exemptions. 

151.2020 Vessels in innocent passage. 

151.2025 Ballast water management 

requirements. 

151.2026 Alternate management systems. 

151.2030 Ballast water discharge standard 

(BWDS). 

151.2035 Implementation schedule for 

approved ballast water management 

methods. 

151.2036 Extension of compliance date. 

151.2040 Discharge of ballast water in 

extraordinary circumstances. 

151.2050 Additional requirements— 

nonindigenous species reduction 

practices. 

151.2055 Deviation from planned voyage. 

151.2060 Reporting requirements. 

151.2065 Equivalent reporting methods for 

vessels other than those entering the 

Great Lakes or Hudson River after 

operating outside the U.S. Exclusive 

Economic Zone or Canadian equivalent. 

151.2070 Recordkeeping requirements. 

151.2075 Enforcement and compliance. 

151.2080 Penalties. 

Authority: 16 U.S.C. 4711; Department of 

Homeland Security Delegation No. 0170.1. 

Subpart D—Ballast Water Management 

for Control of Nonindigenous Species 

in Waters of the United States 

§ 151.2000 Purpose and scope. 

This subpart implements the 

provisions of the Nonindigenous 

Aquatic Nuisance Prevention and 

Control Act of 1990 (16 U.S.C. 4701– 

4751), as amended by the National 

Invasive Species Act of 1996. 

§ 151.2005 Definitions. 

(a) Unless otherwise stated in this 

section, the definitions in 33 CFR 

151.1504, 33 CFR 160.204, and the 

United Nations Convention on the Law 

of the Sea apply to this subpart. 

(b) As used in this subpart: 

Captain of the Port (COTP) means the 

Coast Guard officer designated by the 

Commandant to command a COTP Zone 

as described in part 3 of this chapter. 

Constructed in respect of a vessel 

means a stage of construction when— 

(1) The keel of a vessel is laid; 

(2) Construction identifiable with the 

specific vessel begins; 

(3) Assembly of the vessel has 

commenced and comprises at least 50 

tons or 1 percent of the estimated mass 

of all structural material, whichever is 

less; or 

(4) The vessel undergoes a major 

conversion. 

Exchange means to replace the water 

in a ballast tank using one of the 

following methods: 

(1) Flow-through exchange means to 

flush out ballast water by pumping in 

mid-ocean water at the bottom of the 

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tank and continuously overflowing the 

tank from the top until three full 

volumes of water has been changed to 

minimize the number of original 

organisms remaining in the tank. 

(2) Empty/refill exchange means to 

pump out the ballast water taken on in 

ports, estuarine, or territorial waters 

until the pump(s) lose suction, then 

refilling it with mid-ocean water. 

International Maritime Organization 

(IMO) ballast water management 

guidelines mean the Guidelines for the 

Control and Management of Ships’ 

Ballast Water to Minimize the Transfer 

of Harmful Aquatic Organisms and 

Pathogens (IMO Resolution A.868 (20), 

adopted November 1997). 

National Ballast Information 

Clearinghouse (NBIC) means the 

National Ballast Information 

Clearinghouse operated by the Coast 

Guard and the Smithsonian 

Environmental Research Center as 

mandated under the National Invasive 

Species Act of 1996. 

Port or place of departure means any 

port or place in which a vessel is 

anchored or moored. 

Port or place of destination means any 

port or place to which a vessel is bound 

to anchor or moor. 

Seagoing vessel means a vessel in 

commercial service that operates 

beyond the boundary line established by 

46 CFR part 7. It does not include a 

vessel that navigates exclusively on 

inland waters. 

Shipboard Technology Evaluation 

Program (STEP) means a Coast Guard 

research program intended to facilitate 

research, development, and shipboard 

testing of effective BWMS. STEP 

requirements are located at: http:// 

www.uscg.mil/ 

environmental_standards/. 

United States means the States, the 

District of Columbia, Guam, American 

Samoa, the Virgin Islands, the 

Commonwealth of Puerto Rico, the 

Commonwealth of the Northern Mariana 

Islands, and any other territory or 

possession over which the United States 

exercises sovereignty. 

Voyage means any transit by a vessel 

destined for any United States port or 

place. 

§ 151.2010 Applicability. 

This subpart applies to all nonrecreational vessels, U.S. and foreign, 

that are equipped with ballast tanks and 

operate in the waters of the United 

States, except as expressly provided in 

§§ 151.2015 or 151.2020 of this subpart. 

§ 151.2013 Severability. 

If a court finds any portion of this 

subpart to have been promulgated 

without proper authority, the remainder 

of this subpart will remain in full effect. 

§ 151.2015 Exemptions. 

(a) The following vessels are exempt 

from all of the requirements of this 

subpart: 

(1) Any Department of Defense or 

Coast Guard vessel subject to the 

requirements of section 1103 of the 

Nonindigenous Aquatic Nuisance 

Prevention and Control Act, as amended 

by the National Invasive Species Act; or 

any vessel of the Armed Forces, as 

defined in the Federal Water Pollution 

Control Act (33 U.S.C. 1322(a)), that is 

subject to the ‘‘Uniform National 

Discharge Standards for Vessels of the 

Armed Forces’’ (33 U.S.C. 1322(n)). 

(2) Any warship, naval auxiliary, or 

other vessel owned or operated by a 

foreign state and used, for the time 

being, only on government noncommercial service. However, such 

vessels should act in a manner 

consistent, so far as is reasonable and 

practicable, with this subpart. 

(b) The following vessels are exempt 

from the requirements of §§ 151.2025 

(ballast water management (BWM) 

requirements), 151.2060 (reporting), and 

151.2070 (recordkeeping) of this 

subpart: 

(1) Crude oil tankers engaged in 

coastwise trade. 

(2) Vessels that operate exclusively 

within one Captain of the Port (COTP) 

Zone. 

(c) The following vessels are exempt 

only from the requirements of 

§ 151.2025 (BWM requirements) of this 

subpart: 

(1) Seagoing vessels that operate in 

more than one COTP Zone, do not 

operate outside of the Exclusive 

Economic Zone (EEZ), and are less than 

or equal to 1,600 gross register tons or 

less than or equal to 3,000 gross tons 

(International Convention on Tonnage 

Measurement of Ships, 1969). 

(2) Non-seagoing vessels. 

(3) Vessels that take on and discharge 

ballast water exclusively in one COTP 

Zone. 

§ 151.2020 Vessels in innocent passage. 

A foreign vessel that is merely 

traversing the territorial sea of the 

United States (unless bound for, 

entering or departing a U.S. port or 

navigating the internal waters of the 

U.S.) does not fall within the 

applicability of this subpart. 

§ 151.2025 Ballast water management 

requirements. 

(a) The master, owner, operator, agent, 

or person in charge of a vessel equipped 

with ballast tanks that operates in the 

waters of the United States must employ 

one of the following ballast water 

management methods: 

(1) Install and operate a ballast water 

management system (BWMS) that has 

been approved by the Coast Guard 

under 46 CFR part 162. The BWMS 

must be installed in accordance with 

§ 151.2035(b) of this subpart. Following 

installation, the master, owner, operator, 

agent, or person in charge of the vessel 

subject to this subpart must properly 

maintain the BWMS in accordance with 

all manufacturer specifications. Unless 

otherwise expressly provided for in this 

subpart, the master, owner, operator, 

agent, or person in charge of vessels 

employing a Coast Guard-approved 

BWMS must meet the applicable ballast 

water discharge standard (BWDS), 

found in § 151.2030 of this subpart, at 

all times of discharge into the waters of 

the United States. 

(2) Use only water from a U.S. public 

water system (PWS), as defined in 40 

CFR 141.2, that meets the requirements 

of 40 CFR parts 141 and 143 as ballast 

water. Vessels using water from a PWS 

as ballast must maintain a record of 

which PWS they received the water 

from as well as a receipt, invoice, or 

other documentation from the PWS 

indicating that water came from that 

system. Furthermore, they must certify 

that they have met the conditions in 

paragraphs (a)(2)(i) or (ii) of this section, 

as applicable, and describe in the BWM 

plan the procedures to be used to ensure 

compliance with those conditions, and 

thereafter document such compliance in 

the BW record book. Vessels using water 

from a PWS must use such water 

exclusively unless the usage is in 

accordance with § 151.2040 of this 

subpart. Vessels using PWS water as 

ballast must have either— 

(i) Previously cleaned the ballast 

tanks (including removing all residual 

sediments) and not subsequently 

introduced ambient water; or 

(ii) Never introduced ambient water to 

those tanks and supply lines. 

(3) Perform complete ballast water 

exchange in an area 200 nautical miles 

from any shore prior to discharging 

ballast water, unless the vessel is 

required to employ an approved BWMS 

per the schedule found in § 151.2035(b) 

of this subpart. An alternate 

management system (AMS) that meets 

the requirements of § 151.2026 of this 

subpart may also be used, so long as it 

was installed on the vessel prior to the 

date that the vessel is required to 

comply with the BWDS in accordance 

with § 151.2035(b) of this subpart. If 

using an AMS, the master, owner, 

operator, agent, or person in charge of 

the vessel subject to this subpart may 

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employ the AMS for no longer than 5 

years from the date they would 

otherwise be required to comply with 

the BWDS in accordance with 

§ 151.2035(b) of this subpart; 

(4) Do not discharge ballast water into 

waters of the United States. 

(5) Discharge to a facility onshore or 

to another vessel for purposes of 

treatment. Any vessel owner/operator 

discharging ballast water to a facility 

onshore or to another vessel must 

ensure that all vessel piping and 

supporting infrastructure up to the last 

manifold or valve immediately before 

the dock manifold connection of the 

receiving facility or similar 

appurtenance on a reception vessel 

prevents untreated ballast water from 

being discharged into waters of the 

United States. 

(b) Requests for approval of BWMS 

must be submitted to the Commanding 

Officer (Marine Safety Center), U.S. 

Coast Guard Marine Safety Center, 2100 

2nd St. SW., Stop 7102, Washington, DC 

20593–7102, or by email to 

msc@uscg.mil, in accordance with 46 

CFR part 162. 

(c) A vessel engaged in the foreign 

export of Alaskan North Slope Crude 

Oil must comply with §§ 151.2060 and 

151.2070 of this subpart, as well as with 

the provisions of 15 CFR 754.2(j)(1)(iii). 

Section 15 CFR 754.2(j)(1)(iii) requires a 

mandatory program of deep water 

ballast exchange unless doing so would 

endanger the safety of the vessel or 

crew. 

(d) This subpart does not authorize 

the discharge of oil or noxious liquid 

substances (NLS) in a manner 

prohibited by United States or 

international laws or regulations. Ballast 

water carried in any tank containing a 

residue of oil, NLS, or any other 

pollutant must be discharged in 

accordance with applicable laws and 

regulations. 

(e) This subpart does not affect or 

supersede any requirement or 

prohibition pertaining to the discharge 

of ballast water into the waters of the 

United States under the Federal Water 

Pollution Control Act (33 U.S.C. 1251 to 

1376). 

(f) This subpart does not affect or 

supersede any requirement or 

prohibition pertaining to the discharge 

of ballast water into the waters of the 

United States under the National Marine 

Sanctuaries Act (16 U.S.C. 1431 et seq.). 

(g) Vessels with installed BWMS for 

testing and evaluation by an 

Independent Laboratory in accordance 

with the requirements of 46 CFR 

162.060–10 and 46 CFR 162.060–28 will 

be deemed to be in compliance with 

paragraph (a)(1) of this section. 

§ 151.2026 Alternate management 

systems. 

(a) A manufacturer whose ballast 

water management system (BWMS) has 

been approved by a foreign 

administration pursuant to the 

standards set forth in the International 

Convention for the Control and 

Management of Ships’ Ballast Water and 

Sediments, 2004, may request in 

writing, for the Coast Guard to make a 

determination that their BWMS is an 

alternate management system (AMS). 

Requests for determinations under this 

section must include: 

(1) The type-approval certificate for 

the BWMS. 

(2) Name, point of contact, address, 

and phone number of the authority 

overseeing the program; 

(3) Final test results and findings, 

including the full analytical procedures 

and methods, results, interpretations of 

the results, and full description and 

documentation of the Quality Assurance 

procedures (i.e., sample chain of 

custody forms, calibration records, etc.); 

(4) A description of any modifications 

made to the system after completion of 

the testing for which a determination is 

requested; and 

(5) A type approval application as 

described under 46 CFR 162.060–12. 

(i) Once ballast water management 

systems are type approved by the Coast 

Guard and available for a given class, 

type of vessels, or specific vessel, those 

vessels will no longer be able to install 

AMS in lieu of type approved systems. 

(ii) [Reserved] 

(b) Requests for determinations must 

be submitted in writing to the 

Commanding Officer, U.S. Coast Guard 

Marine Safety Center, 2100 2nd St. SW., 

Stop 7102, Washington, DC 20593– 

7102. 

(c) If using an AMS that was installed 

on the vessel prior to the date that the 

vessel is required to comply with the 

ballast water discharge standard in 

accordance with § 151.2035(b), the 

master, owner, operator, agent, or 

person in charge of the vessel subject to 

this subpart may employ such AMS for 

no longer than 5 years from the date 

they would otherwise be required to 

comply with the ballast water discharge 

standard in accordance with the 

implementation schedule in § 151.2035 

(b) of this subpart. To ensure the safe 

and effective management and operation 

of the AMS equipment, the master, 

owner, operator, agent or person in 

charge of the vessel must ensure the 

AMS is maintained and operated in 

conformity with the system 

specifications. 

(d) An AMS determination issued 

under this section may be suspended, 

withdrawn, or terminated in accordance 

with the procedures contained in 46 

CFR 162.060–18. 

§ 151.2030 Ballast water discharge 

standard (BWDS). 

(a) Vessels employing a Coast Guardapproved ballast water management 

system (BWMS) must meet the 

following BWDS by the date listed in 

§ 151.2035(b) of this subpart: 

(1) For organisms greater than or 

equal to 50 micrometers in minimum 

dimension: Discharge must include 

fewer than 10 organisms per cubic meter 

of ballast water. 

(2) For organisms less than 50 

micrometers and greater than or equal to 

10 micrometers: Discharge must include 

fewer than 10 organisms per milliliter 

(mL) of ballast water. 

(3) Indicator microorganisms must not 

exceed: 

(i) For toxicogenic Vibrio cholerae 

(serotypes O1 and O139): A 

concentration of less than 1 colony 

forming unit (cfu) per 100 mL. 

(ii) For Escherichia coli: a 

concentration of fewer than 250 cfu per 

100 mL. 

(iii) For intestinal enterococci: A 

concentration of fewer than 100 cfu per 

100 mL. 

(b) [Reserved] 

(c) The Coast Guard will conduct a 

practicability review as follows: 

(1) No later than January 1, 2016, the 

Coast Guard will publish the results of 

a practicability review to determine— 

(i) Whether technology to comply 

with a performance standard more 

stringent than that required by 

paragraph (a) of this section can be 

practicably implemented, in whole or in 

part, and, if so, the Coast Guard will 

schedule a rulemaking to implement the 

more stringent standard; and 

(ii) Whether testing protocols that can 

assure accurate measurement of 

compliance with a performance 

standard more stringent than that 

required by paragraph (a) of this section 

can be practicably implemented. 

(2) If the Coast Guard determines on 

the basis of a practicability review 

conducted under paragraph (c)(1) of this 

section that technology to achieve a 

significant improvement in ballast water 

treatment efficacy could be practicably 

implemented, the Coast Guard will 

report this finding and will, no later 

than January 1, 2017, initiate a 

rulemaking that would establish 

performance standards and other 

requirements or conditions to ensure to 

the maximum extent practicable that 

aquatic nuisance species are not 

discharged into waters of the United 

States from vessels. If the Coast Guard 

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subsequently finds that it is not able to 

meet this schedule, the Coast Guard will 

publish a notice in the Federal Register 

so informing the public, along with an 

explanation of the reason for the delay, 

and a revised schedule for rule making 

that shall be as expeditious as 

practicable. 

(3) When conducting the 

practicability review as described in 

paragraph (c)(1) of this section, the 

Coast Guard will consider— 

(i) The capability of any identified 

technology to achieve a more stringent 

BWDS, in whole or in part; 

(ii) The effectiveness of any identified 

technology in the shipboard 

environment; 

(iii) The compatibility of any 

identified technology with vessel design 

and operation; 

(iv) The safety of any identified 

technology; 

(v) Whether the use of any identified 

technology may have an adverse impact 

on the environment; 

(vi) The cost of any identified 

technology; 

(vii) The economic impact of any 

identified technology, including the 

impact on shipping, small businesses, 

and other uses of the aquatic 

environment; 

(viii) The availability, accuracy, 

precision, and cost of methods and 

technologies for measuring the 

concentrations of organisms, treatment 

chemicals, or other pertinent parameters 

in treated ballast water as would be 

required under any alternative discharge 

standards; 

(ix) Any requirements for the 

management of ballast water included 

in the most current version of the 

Environmental Protection Agency’s 

Vessel General Permit and any 

documentation available from the EPA 

regarding the basis for these 

requirements; and 

(x) Any other factor that the Coast 

Guard considers appropriate that is 

related to the determination of whether 

identified technology is performable, 

practicable, and/or may possibly 

prevent the introduction and spread of 

non-indigenous aquatic invasive 

species. 

§ 151.2035 Implementation schedule for 

approved ballast water management 

methods. 

(a) To discharge ballast water into 

waters of the United States, the master, 

owner, operator, agent, or person in 

charge of a vessel subject to § 151.2025 

of this subpart must either ensure that 

the ballast water meets the ballast water 

discharge standard as defined in 

§ 151.2030(a), use an AMS as described 

in § 151.2025(a)(3) or ballast with water 

from a U.S. public water system, as 

described in § 151.2025(a)(2), according 

to the schedule in paragraph (b) of this 

section. 

(b) Implementation Schedule for the 

Ballast Water Management Discharge 

Standard for vessels using a Coast 

Guard approved BWMS to manage 

ballast water discharged to waters of the 

U.S. After the dates listed in Table 

151.2035(b), vessels may use a USCGapproved BWMS and comply with the 

discharge standard, use PWS per 

§ 151.2025(a)(2), or use a previously 

installed AMS per § 151.2025(a)(3). 

TABLE 151.2035(b)—IMPLEMENTATION SCHEDULE FOR APPROVED BALLAST WATER MANAGEMENT METHODS

Vessel’s ballast 

water capacity Date constructed Vessel’s compliance date 

New vessels ........................ All ....................................... On or after December 1, 2013 ................ On delivery. 

Existing vessels ................... Less than 1500 m3 ............ Before December 1, 2013 ....................... First scheduled drydocking after January 

1, 2016. 

1500–5000 m3 ................... Before December 1, 2013 ....................... First scheduled drydocking after January 

1, 2014. 

Greater than 5000 m3 ....... Before December 1, 2013 ....................... First scheduled drydocking after January 

1, 2016. 

§ 151.2036 Extension of compliance date. 

The Coast Guard may grant an 

extension to the implementation 

schedule listed in § 151.2035(b) of this 

subpart only in those cases where the 

master, owner, operator, agent, or 

person in charge of a vessel subject to 

this subpart can document that despite 

all efforts to meet the ballast water 

discharge standard requirements in 

§ 151.2030 of this subpart, compliance 

is not possible. Any extension request 

must be made no later than 12 months 

before the scheduled implementation 

date listed in § 151.2035(b) of this 

subpart and submitted in writing to the 

Commandant (CG–522), U.S. Coast 

Guard Office of Operating and 

Environmental Standards, 2100 2nd St. 

SW., Stop 7126, Washington, DC 20593– 

7126. Summary information concerning 

all extension decisions, including the 

name of the vessel and vessel owner, the 

term of the extension, and the basis for 

the extension will be promptly posted 

on the Internet. Extensions will be for 

no longer than the minimum time 

needed, as determined by the Coast 

Guard, for the vessel to comply with the 

requirements of § 151.2030. 

§ 151.2040 Discharge of ballast water in 

extraordinary circumstances. 

(a) The Coast Guard will allow the 

master, owner, operator, agent, or 

person in charge of a vessel that cannot 

practicably meet the requirements of 

§ 151.2025(a) of this subpart, either 

because its voyage does not take it into 

waters 200 nautical miles or greater 

from any shore for a sufficient length of 

time and the vessel retains ballast water 

onboard or because the master of the 

vessel has identified safety or stability 

concerns, to discharge ballast water in 

areas other than the Great Lakes and the 

Hudson River north of the George 

Washington Bridge. 

(1) The Coast Guard will not allow 

such a discharge if the vessel is required 

to have a Coast Guard-approved ballast 

water management system (BWMS) per 

the implementation schedule found in 

§ 151.2035(b) of this subpart. 

(2) If the Coast Guard allows the 

discharge of ballast water as described 

in paragraph (a) of this section, the 

master, owner, operator, agent, or 

person in charge of the vessel must 

discharge only that amount of ballast 

water operationally necessary to ensure 

the safety of the vessel for cargo 

operations. 

(3) Ballast water records must be 

made available to the local Captain of 

the Port (COTP) upon request. 

(4) Vessels on a voyage to the Great 

Lakes or the Hudson River north of the 

George Washington Bridge must comply 

with the requirements of 33 CFR 

151.1515. 

(b) If the installed BWMS required by 

this subpart stops operating properly 

during a voyage, or the vessel’s BWM 

method is unexpectedly unavailable, the 

person directing the movement of the 

vessel must ensure that the problem is 

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reported to the nearest COTP or District 

Commander as soon as practicable. The 

vessel may continue to the next port of 

call, subject to the directions of the 

COTP or District Commander, as 

provided by part 160 of this chapter. 

(1) The Coast Guard will normally 

allow a vessel that cannot practicably 

meet the requirements of 

§ 151.2025(a)(1) of this subpart because 

its installed BWMS is inoperable, or the 

vessel’s BWM method is unexpectedly 

unavailable, to employ one of the other 

ballast water management (BWM) 

methods listed in § 151.2025(a) of this 

subpart. 

(2) If the master of the vessel 

determines that the vessel cannot 

employ other BWM methods due to the 

voyage or safety concerns listed in 

paragraph (a) of this section, the Coast 

Guard will normally allow the vessel to 

discharge ballast water in areas other 

than the Great Lakes and the Hudson 

River north of the George Washington 

Bridge. 

(3) If the Coast Guard approves such 

an allowance, the vessel must discharge 

only that amount of ballast water 

operationally necessary to ensure the 

safety and stability of the vessel for 

cargo operations. Ballast water records 

must be made available to the local 

COTP upon request. 

(c) Nothing in this subpart relieves the 

master, owner, operator, agent, or 

person in charge of a vessel of any 

responsibility, including ensuring the 

safety and stability of the vessel and the 

safety of the crew and passengers. 

§ 151.2050 Additional requirements— 

nonindigenous species reduction practices. 

The master, owner, operator, agent, or 

person in charge of any vessel equipped 

with ballast water tanks that operates in 

the waters of the United States must 

follow these practices: 

(a) Avoid the discharge or uptake of 

ballast water in areas within, or that 

may directly affect, marine sanctuaries, 

marine preserves, marine parks, or coral 

reefs. 

(b) Minimize or avoid uptake of 

ballast water in the following areas and 

situations: 

(1) Areas known to have infestations 

or populations of harmful organisms 

and pathogens (e.g., toxic algal blooms). 

(2) Areas near sewage outfalls. 

(3) Areas near dredging operations. 

(4) Areas where tidal flushing is 

known to be poor or times when a tidal 

stream is known to be turbid. 

(5) In darkness, when bottomdwelling organisms may rise up in the 

water column. 

(6) Where propellers may stir up the 

sediment. 

(7) Areas with pods of whales, 

convergence zones, and boundaries of 

major currents. 

(c) Clean the ballast tanks regularly to 

remove sediments. Sediments must be 

disposed of in accordance with local, 

State, and Federal regulations. 

(d) Discharge only the minimal 

amount of ballast water essential for 

vessel operations while in the waters of 

the United States. 

(e) Rinse anchors and anchor chains 

when the anchor is retrieved to remove 

organisms and sediments at their places 

of origin. 

(f) Remove fouling organisms from the 

vessel’s hull, piping, and tanks on a 

regular basis and dispose of any 

removed substances in accordance with 

local, State and Federal regulations. 

(g) Maintain a ballast water 

management (BWM) plan that has been 

developed specifically for the vessel and 

that will allow those responsible for the 

plan’s implementation to understand 

and follow the vessel’s BWM strategy 

and comply with the requirements of 

this subpart. The plan must include— 

(1) Detailed safety procedures; 

(2) Actions for implementing the 

mandatory BWM requirements and 

practices; 

(3) Detailed fouling maintenance and 

sediment removal procedures; 

(4) Procedures for coordinating the 

shipboard BWM strategy with Coast 

Guard authorities; 

(5) Identification of the designated 

officer(s) in charge of ensuring that the 

plan is properly implemented; 

(6) Detailed reporting requirements 

and procedures for ports and places in 

the United States where the vessel may 

visit; and 

(7) A translation of the plan into 

English, French, or Spanish if the 

vessel’s working language is another 

language. 

(h) Train the master, operator, person 

in charge, and crew on the application 

of ballast water and sediment 

management and treatment procedures. 

(i) When discharging ballast water to 

a reception facility in the United States, 

discharge only to reception facilities 

that have an NPDES permit to discharge 

ballast water. 

§ 151.2055 Deviation from planned voyage. 

As long as ballast water exchange 

(BWE) is an allowable ballast water 

management option under §§ 151.2025 

and 151.2035 of this subpart, the Coast 

Guard will not require a vessel to 

deviate from its voyage or delay the 

voyage in order to conduct BWE. A 

vessel may be required to deviate from 

its voyage or delay the voyage if BWE 

is directed by a Captain of the Port 

pursuant to § 151.2040(b) of this 

subpart. 

§ 151.2060 Reporting requirements. 

(a) Ballast water reporting 

requirements exist for each vessel 

subject to this subpart bound for ports 

or places of the United States regardless 

of whether a vessel operated outside of 

the Exclusive Economic Zone (EEZ), 

unless exempted in § 151.2015 of this 

subpart. 

(b) The master, owner, operator, 

agent, or person in charge of a vessel 

subject to this subpart and this section 

must provide the information required 

by § 151.2070 of this subpart in 

electronic or written form to the 

Commandant, U.S. Coast Guard or the 

appropriate Captain of the Port (COTP). 

The Ballast Water Reporting Form 

(Office of Management and Budget form 

Control No. 1625–0069) and the 

instructions for completing it are 

available on the National Ballast 

Information Clearinghouse’s Web site at 

http://invasions.si.edu/nbic/ 

submit.html. Information must be 

submitted as follows: 

(1) For any vessel bound for the Great 

Lakes from outside the EEZ: 

(i) Fax the required information at 

least 24 hours before the vessel arrives 

in Montreal, Quebec to the U.S. Coast 

Guard (USCG) COTP, Buffalo, Massena 

Detachment (315–769–5032). 

(ii) Non-U.S. and non-Canadian flag 

vessels may complete the ballast water 

information section of the form required 

by the St. Lawrence Seaway, ‘‘Pre-entry 

Information from Foreign Flagged 

Vessels Form,’’ and submit it in 

accordance with the applicable Seaway 

notice as an alternative to this 

requirement. 

(2) For any vessel bound for the 

Hudson River north of the George 

Washington Bridge entering from 

outside the EEZ: Fax the required 

information to the USCG COTP, New 

York (718–354–4249) at least 24 hours 

before the vessel enters New York, NY. 

(3) For any vessel that is equipped 

with ballast water tanks and bound for 

ports or places in the United States and 

not addressed in paragraphs (b)(1) and 

(b)(2) of this section: If a vessel’s voyage 

is less than 24 hours, report the required 

information before departing the port or 

place of departure. If a voyage exceeds 

24 hours, report the required 

information at least 24 hours before 

arrival at the port or place of 

destination. The information must be 

sent to the National Ballast Information 

Clearinghouse using only one of the 

following means: 

(i) Via the Internet at http:// 

invasions.si.edu/nbic/submit.html. 

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(ii) Email to NBIC@BallastReport.org. 

(iii) Fax to 301–261–4319. 

(iv) Mail to U.S. Coast Guard, c/o 

Smithsonian Environmental Research 

Center, P.O. Box 28, Edgewater, MD 

21037–0028. 

(c) If the information submitted in 

accordance with this section changes, 

the master, owner, operator, agent, or 

person in charge of the vessel must 

submit an amended report before the 

vessel departs the waters of the United 

States. 

§ 151.2065 Equivalent reporting methods 

for vessels other than those entering the 

Great Lakes or Hudson River after 

operating outside the U.S. Exclusive 

Economic Zone or Canadian equivalent. 

For vessels required to report under 

§ 151.2060(b)(3) of this subpart, the 

Chief, Environmental Standards 

Division (CG–5224), acting for the 

Assistant Commandant for Marine 

Safety, Security, and Stewardship (CG– 

5), may, upon receipt of a written 

request, consider and approve 

alternative methods of reporting if— 

(a) Such methods are at least as 

effective as those required by § 151.2060 

of this subpart; and 

(b) Compliance with § 151.2060 of 

this subpart is economically or 

physically impractical. The Chief, 

Environmental Standards Division (CG– 

5224), will approve or disapprove a 

request submitted in accordance with 

this section within 30 days of receipt of 

the request. 

§ 151.2070 Recordkeeping requirements. 

(a) The master, owner, operator, agent, 

or person in charge of a vessel bound for 

a port or place in the United States, 

unless specifically exempted by 

§ 151.2015 of this subpart, must ensure 

the maintenance of written records that 

include the following information: 

(1) Vessel information. This includes 

the name, International Maritime 

Organization (IMO) number (official 

number if IMO number is not issued), 

vessel type, owner or operator, gross 

tonnage, call sign, and State of registry 

(flag). 

(2) Voyage information. This includes 

the date and port of arrival, vessel agent, 

last port and country of call, and next 

port and country of call. 

(3) Total ballast water information. 

This includes the total ballast water 

capacity, total volume of ballast water 

onboard, total number of ballast water 

tanks, and total number of ballast water 

tanks in ballast. Use units of 

measurements such as metric tons (MT), 

cubic meters (m3), long tons (LT), and 

short tons (ST). 

(4) Ballast water management (BWM). 

This includes the total number of ballast 

tanks/holds that are to be discharged 

into the waters of the United States or 

to a reception facility. 

(i) If the vessel uses an alternative 

BWM method, note the number of tanks 

that are managed using an alternative 

method, as well as the type of method 

used. 

(ii) Indicate whether the vessel has a 

BWM plan and IMO ballast water 

management guidelines onboard, and 

whether the BWM plan is used. 

(5) Information on ballast water tanks 

that are to be discharged into the waters 

of the United States or to a reception 

facility. Include the following: 

(i) The origin of ballast water. This 

includes date(s), location(s), volume(s) 

and temperature(s). If a tank has 

undergone ballast water exchange 

(BWE), list the loading port of the 

ballast water that was discharged during 

the exchange. 

(ii) The date(s), location(s), volume(s), 

method, thoroughness (percentage 

exchanged, if BWE conducted), and sea 

height at time of exchange of any ballast 

water exchanged or otherwise managed. 

(iii) The expected date, location, 

volume, and salinity of any ballast water 

to be discharged into the waters of the 

United States or to a reception facility. 

(6) Discharge of sediment. Include the 

name and location of the facility where 

sediment disposal will take place, if 

sediment is to be discharged within the 

jurisdiction of the United States. 

(7) Certification of accurate 

information. Include the master, owner, 

operator, agent, person in charge, or 

responsible officer’s printed name, title, 

and signature attesting to the accuracy 

of the information provided and 

certifying compliance with the 

requirements of this subpart. 

(b) The master, owner, operator, 

agent, or person in charge of a vessel 

subject to this section must retain a 

signed copy of this information onboard 

the vessel for 2 years. 

(c) Two alternative ways to meet the 

requirements of this section are— 

(1) Completing and retaining the 

Ballast Water Reporting Form contained 

in the IMO ballast water management 

guidelines; or 

(2) Completing the ballast water 

information section of the form required 

by the St. Lawrence Seaway Pre-entry 

Information from Foreign Flagged 

Vessels. 

(d) The master, owner, operator, 

agent, or person in charge of a vessel 

subject to this section must retain the 

monitoring records required in 46 CFR 

162.060–20(b) for 2 years. These records 

may be stored on digital media but must 

be viewable for Coast Guard inspection. 

(e) The information required by this 

subpart may be used to satisfy the 

ballast water recordkeeping 

requirements for vessels subject to 

§ 151.2025(c) of this subpart and 33 CFR 

part 151 subpart C. 

§ 151.2075 Enforcement and compliance. 

(a) The master, owner, operator, agent, 

or person in charge of a vessel must 

provide the Captain of the Port (COTP) 

with access to the vessel in order to take 

samples of ballast water and sediment, 

examine documents, and make other 

appropriate inquiries to assess the 

compliance of any vessel subject to this 

subpart. 

(b) The master, owner, operator, 

agent, or person in charge of a vessel 

subject to this section must provide the 

records to the COTP upon request, as 

required by § 151.2070 of this subpart. 

(c) Vessels with installed ballast water 

management systems are subject to 

Coast Guard inspection. Every vessel 

must have a sampling port(s) designed 

and installed in accordance with 46 CFR 

162.060–28(f) and (f)(2) at each 

overboard discharge point. 

(d) In this subpart, wherever multiple 

entities are responsible for compliance 

with any requirement of the rule, each 

entity is jointly liable for a violation of 

such requirement. 

§ 151.2080 Penalties. 

(a) A person who violates this subpart 

is liable for a civil penalty not to exceed 

$35,000. Each day of a continuing 

violation constitutes a separate 

violation. A vessel operated in violation 

of the regulations is liable in rem for any 

civil penalty assessed under this subpart 

for that violation. 

(b) A person who knowingly violates 

the regulations of this subpart is guilty 

of a class C felony. 

Appendix to Subpart D of Part 151 

[Removed] 

Appendix to Subpart D [Removed] 

■ 13. Remove the Appendix to subpart 

D of part 151. 

Title 46—Shipping 

CHAPTER I—COAST GUARD 

Subchapter Q—Equipment, Construction, 

and Materials: Specifications and Approval 

PART 162—ENGINEERING 

EQUIPMENT 

■ 14. Add subpart 162.060 to part 162 

to read as follows: 

Subpart 162.060—Ballast Water 

Management Systems 

Sec. 

162.060–1 Purpose and scope. 

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17312 Federal Register / Vol. 77, No. 57 / Friday, March 23, 2012 / Rules and Regulations 

162.060–3 Definitions. 

162.060–5 Incorporation by reference. 

162.060–10 Approval procedures. 

162.060–12 Use and acceptance of existing 

test data. 

162.060–14 Information requirements for 

the ballast water management system 

(BWMS) application. 

162.060–16 Changes to an approved ballast 

water management system (BWMS). 

162.060–18 Suspension, withdrawal or 

termination of approval. 

162.060–20 Design and construction 

requirements. 

162.060–22 Marking requirements. 

162.060–24 Test Plan requirements. 

162.060–26 Land-based testing 

requirements. 

162.060–28 Shipboard testing requirements. 

162.060–30 Testing requirements for ballast 

water management system (BWMS) 

components. 

162.060–32 Testing and evaluation 

requirements for active substances, 

preparations, and relevant chemicals. 

162.060–34 Test Report requirements. 

162.060–36 Quality Assurance Project Plan 

(QAPP) requirements. 

162.060–38 Operation, Maintenance, and 

Safety Manual (OMSM). 

162.060–40 Requirements for independent 

laboratories (ILs). 

162.060–42 Responsibilities for 

independent laboratories (ILs). 

Authority: 16 U.S.C. 4711; Department of 

Homeland Security Delegation No. 0170.1. 

Subpart 162.060—Ballast Water 

Management Systems 

§ 162.060–1 Purpose and scope. 

This subpart contains procedures and 

requirements for approval of complete 

ballast water management systems to be 

installed onboard vessels for the 

purpose of complying with the ballast 

water discharge standard of 33 CFR part 

151, subparts C and D. 

§ 162.060–3 Definitions. 

As used in this subpart— 

Active substance means a chemical or 

an organism, including a virus or a 

fungus, that has a general or specific 

action on or against nonindigenous 

species. 

Administration means the 

government of the nation/State under 

whose authority a vessel is operating. 

Ballast water means any water and 

suspended matter taken onboard a 

vessel to control or maintain trim, 

draught, stability, or stresses of the 

vessel, regardless of how it is carried. 

Ballast water management system 

(BWMS) means any system which 

processes ballast water to kill, render 

harmless, or remove organisms. The 

BWMS includes all ballast water 

treatment equipment and all associated 

control and monitoring equipment. 

Ballast water system means the tanks, 

piping, valves, pumps, sea chests, and 

any other associated equipment that the 

vessel uses for the purposes of 

ballasting. 

Ballast water treatment equipment 

means that part of the BWMS that 

mechanically, physically, chemically, or 

biologically processes ballast water, 

either singularly or in combination, to 

kill, render harmless, or remove 

organisms within ballast water and 

sediments. 

Challenge water means water just 

prior to treatment. In land-based tests, 

source water may be augmented to 

achieve required challenge water 

conditions. 

Control and monitoring equipment 

means that part of the BWMS required 

to operate, control, and assess the 

effective operation of the ballast water 

treatment equipment. 

Hazardous location means areas 

where fire or explosion hazards may 

exist due to the presence of flammable 

gases/vapors, flammable liquids, 

combustible dust, or ignitable fibers, as 

determined in accordance with the 

standards of construction applicable to 

the vessel on which the BWMS is to be 

installed. 

Hazardous materials means 

hazardous materials as defined in 49 

CFR 171.8; hazardous substances 

designated under 40 CFR part 116.4; 

reportable quantities as defined under 

40 CFR 117.1; materials that meet the 

criteria for hazard classes and divisions 

in 49 CFR part 173; materials under 46 

CFR 153.40 determined by the Coast 

Guard to be hazardous when 

transported in bulk; flammable liquids 

defined in 46 CFR 30.10–22; 

combustible liquids as defined in 46 

CFR 30.10–15; materials listed in Table 

46 CFR 151.05, Table 1 of 46 CFR 153, 

or Table 4 of 46 CFR part 154; or any 

liquid, liquefied gas, or compressed gas 

listed in 49 CFR 172.101. 

Independent laboratory means an 

organization that meets the 

requirements in 46 CFR 159.010–3. In 

addition to commercial testing 

laboratories, which may include not-forprofit organizations, the Commandant 

may also accept classification societies 

and agencies of governments (including 

State and Federal agencies of the United 

States) that are involved in the 

evaluation, inspection, and testing of 

BWMS. 

In-line treatment means a treatment 

system or technology used to treat 

ballast water during normal flow of 

ballast uptake, discharge, or both. 

In-tank treatment means a treatment 

system or technology used to treat 

ballast water during the time that it 

resides in the ballast tanks. 

Pesticide means any substance or 

mixture of substances intended for 

preventing, destroying, repelling, or 

mitigating any pest as defined under the 

Federal Insecticide, Fungicide, and 

Rodenticide Act (7 U.S.C. 136 et.seq.) 

and 40 CFR 152.3. 

Preparation means any commercial 

formulation containing one or more 

active substances, including any 

additives. This definition also includes 

any active substances generated onboard 

a vessel for the purpose of ballast water 

management to comply with the ballast 

water discharge standard codified in 33 

CFR part 151 subpart C or D. 

Quality Assurance Project Plan 

(QAPP) means a project-specific 

technical document reflecting the 

implementation of Quality Assurance 

and Quality Control activities, including 

specifics of the BWMS to be tested, the 

independent laboratory, and other 

conditions affecting the actual design 

and implementation of the required 

tests and evaluations. 

Relevant chemical means any 

transformation or reaction product that 

is produced during the treatment 

process or in the receiving environment 

and which may be of concern to the 

aquatic environment and human health 

when discharged. 

Representative sample means a 

random sample, in which every item of 

interest (organisms, molecules, etc.) in 

the larger population has an unbiased 

chance of appearing. 

Sampling port means the equipment 

installed in the ballast water piping 

through which representative samples 

of the ballast water being discharged are 

extracted. This is equivalent to the term 

‘‘sampling facility’’ under the 

International Maritime Organization 

(IMO) Guidelines for Ballast Water 

Sampling (G2), published as IMO 

Resolution MEPC.173(58) on October 

10, 2008. 

Source water means the body of water 

from which water is drawn for either 

land-based or shipboard testing. 

Test facility means the location where 

the independent laboratory conducts 

land-based, component, active 

substance, and relevant chemical testing 

and evaluations, as required by this 

subpart. 

§ 162.060–5 Incorporation by reference. 

(a) Certain material is incorporated by 

reference into this part with the 

approval of the Director of the Federal 

Register under 5 U.S.C. 552(a) and 1 

CFR part 51. To enforce any edition 

other than that specified in this section, 

the Coast Guard must publish notice of 

change in the Federal Register and the 

material must be available to the public. 

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All approved material is available for 

inspection at the National Archives and 

Records Administration (NARA). For 

information on the availability of this 

material at NARA, call 202–741–6030 or 

go to http://www.archives.gov/federal_

register/code_of_federal_regulations/

ibr_locations.html. Also, it is available 

for inspection from the Commandant 

(CG–52), Commercial Regulations and 

Standards Directorate, U.S. Coast Guard, 

2100 2nd St. SW., Stop 7126, 

Washington, DC 20593–7126, and is 

available from the sources listed below. 

(b) International Electrotechnical 

Commission (IEC), 3 rue Varembe, P.O. 

Box 131, 1211 Geneva 20, Switzerland. 

(1) IEC 60529, Classification of 

Degrees of Protection by Enclosures (IP 

Code), Edition 2.1 consolidated with 

amendment 1:1999 (dated February, 

2001), IBR approved for § 162.060–30. 

(2) [Reserved] 

(c) International Organization for 

Standardization (ISO), ISO Central 

Secretariat, 1, ch. de la Voie-Creuse, 

Case postale 56 CH–1211 Geneva 20, 

Switzerland. 

(1) ISO/IEC 17025:2005(E), General 

Requirements for the Competence of 

Calibration and Testing Laboratories, 

Second Edition (dated May 15, 2005), 

IBR approved for § 162.060–36. 

(2) ISO/IEC 17025:2005/Cor.1:2006(E), 

General Requirements for the 

Competence of Testing and Calibration 

Laboratories, Technical Corrigendum 1, 

(dated August 15, 2006), IBR approved 

for § 162.060–36. 

(d) U.S. Environmental Protection 

Agency (EPA), Environmental 

Technology Verification Program, 

National Risk Management Research 

Laboratory Office of Research and 

Development, U.S. Environmental 

Protection Agency, 2890 Woodbridge 

Avenue (MS–104), Edison, New Jersey 

08837. 

(1) EPA/600/R–10/146, Generic 

Protocol for the Verification of Ballast 

Water Treatment Technologies, version 

5.1, (dated September 2010), IBR 

approved for §§ 162.060–26 and 

162.060–28 (ETV Protocol). 

(2) [Reserved] 

§ 162.060–10 Approval procedures. 

(a) Not less than 30 days before 

initiating any testing of a ballast water 

management system (BWMS), the 

results of which are intended for use in 

an application for type approval, the 

manufacturer must submit a Letter of 

Intent (LOI) providing as much of the 

following information as possible to the 

Commanding Officer, U.S. Coast Guard 

Marine Safety Center (MSC), 2100 2nd 

St. SW., Stop 7102, Washington, DC 

20593–7102, or by email to 

msc@uscg.mil: 

(1) Manufacturer’s name, address, and 

point of contact, with telephone number 

or email address. 

(2) Name and location of independent 

laboratory and associated test facilities 

and subcontractors, plus expected dates 

and locations for actual testing. 

(3) Model name, model number, and 

type of BWMS. 

(4) Expected date of submission of full 

application package to the Coast Guard. 

(5) Name, type of vessel, and expected 

geographic locations for shipboard 

testing. 

(b) The manufacturer must ensure 

evaluation, inspection, and testing of 

the BWMS is conducted by an 

independent laboratory, accepted by the 

Coast Guard, in accordance with 

§§ 162.060–20 through 162.060–40 of 

this subpart. Testing may begin 30 days 

after submission of the LOI unless 

otherwise directed by the Coast Guard. 

(1) If an evaluation, inspection, or test 

required by this section is not 

practicable or applicable, a 

manufacturer may submit a written 

request to the Commanding Officer, U.S. 

Coast Guard MSC, 2100 2nd St. SW., 

Stop 7102, Washington, DC 20593– 

7102, or by email to msc@uscg.mil, for 

approval of alternatives as equivalent to 

the requirements in this section. The 

request must include the manufacturer’s 

justification for any proposed changes 

and contain full descriptions of any 

proposed alternative tests. 

(2) The Coast Guard will notify the 

manufacturer of its determination under 

paragraph (b)(1) of this section. Any 

limitations imposed by the BWMS on 

testing procedures and all approved 

deviations from any evaluation, 

inspection, or testing required by this 

subpart must be duly noted in the 

Experimental Design section of the Test 

Plan. 

(c) The manufacturer must submit an 

application for approval in accordance 

with § 162.060–14 of this subpart. 

(d) Upon receipt of an application 

completed in compliance with 

§ 162.060–14 of this subpart, the MSC 

will evaluate the application and either 

approve, disapprove, or return it to the 

manufacturer for further revision. 

(e) In addition to tests and evaluations 

required by this subpart, the Coast 

Guard will independently conduct 

environmental analyses of each system 

in accordance with the National 

Environmental Policy Act, the 

Endangered Species Act, and/or other 

environmental statutes. The Coast 

Guard advises applicants that 

applications containing novel processes 

or active substances may encounter 

significantly longer reviews during 

these environmental evaluations. 

(f) A BWMS is eligible for approval 

if— 

(1) It meets the design and 

construction requirements in § 162.060– 

20 of this subpart; 

(2) It is evaluated, inspected, and 

tested under land-based and shipboard 

conditions in accordance with 

§§ 162.060–26 and 162.060–28 of this 

subpart, respectively, and thereby 

demonstrates that it consistently meets 

the ballast water discharge standard in 

33 CFR part 151, subparts C and D; 

(3) All applicable components of the 

BWMS meet the component testing 

requirements of § 162.060–30 of this 

subpart; 

(4) The BWMS meets the 

requirements of § 162.060–32 of this 

subpart if the BWMS uses an active 

substance or preparation; and 

(5) The ballast water discharge, 

preparation, active substance, or 

relevant chemical are not found to be 

persistent, bioaccumulative, or toxic 

when discharged. 

(g) After evaluation of an application, 

the Coast Guard will advise the 

applicant in accordance with 46 CFR 

159.005–13 whether the BWMS is 

approved. If the BWMS is approved, a 

certification number will be issued and 

an approval certificate sent to the 

applicant in accordance with 46 CFR 

2.75–5. The approval certificate will list 

conditions of approval applicable to the 

BWMS. 

§ 162.060–12 Use and acceptance of 

existing test data. 

(a) A manufacturer whose ballast 

water management system (BWMS) has 

completed approval testing for a foreign 

administration in accordance with the 

International Maritime Organization’s 

Guidelines for Approval of Ballast 

Water Management Systems (G8) may 

use the data and information developed 

during such approval testing to support 

the submission of an application 

pursuant to § 162.060–14 of this 

subpart. The applicant must submit the 

data and other information developed 

during approval testing and evaluation 

for another administration, and include 

a concise but thorough explanation of 

how the submission meets or exceeds 

the requirements of this subpart in 

respect to design, material and 

manufacture, and ability to meet the 

BWDS requirements. 

(b) Applications under paragraph (a) 

of this section will not need to comply 

with the requirements for advance 

notice under § 162.060–10(a) of this 

subpart for testing that has already 

occurred; or with the requirements that 

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17314 Federal Register / Vol. 77, No. 57 / Friday, March 23, 2012 / Rules and Regulations 

all evaluation, inspection, and testing of 

the BWMS is conducted by an 

independent laboratory, previously 

accepted by the Coast Guard, under 

§ 162.060–10(b) of this subpart. 

However— 

(1) If the applicant determines, prior 

to submission of an application, that 

one or more aspects of the Coast Guard’s 

requirements for approval of a BWMS 

are not satisfied by the data and 

information developed for approval by 

another administration, and that 

additional testing and evaluation is 

required, the applicant will notify the 

Coast Guard of the intent to conduct the 

new testing in accordance with the 

requirements of § 162.060–10(a) and 

(b)(1) of this subpart. 

(2) While laboratories and test 

facilities that conducted the test and 

evaluation for approval by another 

administration are not required to have 

been designated as independent 

laboratories under the requirements of 

this subpart at the time of such work, as 

would otherwise be required under 

§ 162.060–10(b) of this subpart, all 

laboratories and test facilities must have 

met the requirements under 46 CFR 

159.010–3 and 159.010–5(a) at the time 

of such work. It is the responsibility of 

the applicant to ensure that the 

satisfaction of this requirement is 

adequately documented in the 

application. 

§ 162.060–14 Information requirements for 

the ballast water management system 

(BWMS) application. 

(a) A complete BWMS application 

must contain all of the following 

information: 

(1) The name and location of the 

independent laboratory conducting 

approval tests and evaluations. 

(2) Two sets of plans describing the 

BWMS, as specified in 46 CFR 159.005– 

12. 

(3) An Operation, Maintenance, and 

Safety Manual for the BWMS that meets 

the requirements in § 162.060–38 of this 

subpart. 

(4) A bill of materials showing all 

components and specifications of the 

BWMS. 

(5) A list of any systems or 

components of the BWMS that may 

require certification as marine portable 

tanks. 

(6) A list of any pressure vessels used 

as a part of the BWMS, along with a 

description of the pressure vessel 

building standard, or code, or why the 

pressure vessel should be considered 

exempt from any requirements. 

Manufacturers must also submit 

detailed pressure vessel plans if they 

intend to fabricate pressure vessels, heat 

exchangers, evaporators, and similar 

appurtenances. 

(7) Documentation of all necessary 

approvals, registrations, and other 

documents or certifications required for 

any active substances, preparations, or 

relevant chemicals used by the BWMS. 

The documentation must include the 

following: 

(i) A list of any active substances, 

preparations, or relevant chemicals that 

are used, produced, generated as a 

byproduct, and/or discharged in 

association with the operation of the 

BWMS. 

(ii) A list of all limitations or 

restrictions that must be complied with 

during the approval testing and 

evaluations, including any water quality 

limits established by the Environmental 

Protection Agency, States, or tribes, 

under the Clean Water Act. 

(8) A detailed description of Quality 

Control procedures, in-process and final 

inspections, tests followed in 

manufacturing the item, and 

construction and sales record keeping 

systems. 

(9) The completed Test Report 

required by § 162.060–34 of this subpart 

prepared and submitted by the IL. 

(b) The completed application must 

be sent by the manufacturer to the 

Commanding Officer, U.S. Coast Guard 

Marine Safety Center, 2100 2nd St. SW., 

Stop 7102, Washington, DC 20593– 

7102. 

(c) If examination of the application 

reveals that it is incomplete, the Coast 

Guard will return it to the applicant 

with an explanation. 

(d) Additional information, including 

electronic submission criteria, is 

available at http://homeport.uscg.mil/ 

msc. 

§ 162.060–16 Changes to an approved 

ballast water management system (BWMS). 

(a) The manufacturer of a BWMS that 

is approved by the Coast Guard must 

notify the Commanding Officer, U.S. 

Coast Guard Marine Safety Center 

(MSC), in writing of any change in 

design or intended operational 

conditions of the BWMS. 

(b) The notification required by 

paragraph (a) of this section must 

include— 

(1) A description of the change and its 

advantages; and 

(2) An indication of whether or not 

the original BWMS will be 

discontinued. 

(c) After receipt of the notice and 

information, the Coast Guard will notify 

the manufacturer, in writing, of any 

tests or evaluations that must be 

conducted, and then determine if 

BWMS recertification and/or 

modification is required. The 

manufacturer may appeal this 

determination to the Commandant (CG– 

52), Commercial Regulations and 

Standards Directorate, U.S. Coast Guard, 

2100 2nd St. SW., Stop 7126, 

Washington, DC 20593–7126. 

§ 162.060–18 Suspension, withdrawal, or 

termination of approval. 

The Coast Guard may suspend an 

approval issued under this subpart or 

alternate management system (AMS) 

determination issued under 33 CFR 

151.2026(d) of a ballast water 

management system (BWMS) in 

accordance with 46 CFR 2.75–40, 

withdraw an approval or AMS 

determination in accordance with 46 

CFR 2.75–50(a), or terminate an 

approval or AMS determination in 

accordance with 46 CFR 2.75–50(b) if 

the BWMS or AMS, as manufactured— 

(a) Is found non-compliant with the 

conditions of approval; 

(b) Is unsuitable for the purpose 

intended by the manufacturer; 

(c) Does not meet the requirements of 

applicable laws, rules, and regulations, 

and other Federal requirements when 

installed and operated as intended by 

the manufacturer; or 

(d) Cannot be maintained to operate 

as designed, due to lack of parts or 

necessary support services. 

§ 162.060–20 Design and construction 

requirements. 

(a) Unless otherwise authorized by the 

Commandant, each ballast water 

management system (BWMS) must be 

designed and constructed in a manner 

that— 

(1) Ensures simple and effective 

means for its operation; 

(2) Allows operation to be initiated, 

controlled, and monitored by a single 

individual, with minimal interaction or 

attention once normal operation is 

initiated; 

(3) Is robust and suitable for working 

in the shipboard environment and 

adequate for its intended service; 

(4) Meets recognized national or 

international standards for all related 

marine engineering and electrical 

engineering applications; and 

(5) Operates when the vessel is 

upright, inclined under static conditions 

at any angle of list up to and including 

15°, and when the vessel is inclined 

under dynamic, rolling conditions at 

any angle of list up to and including 

22.5° and, simultaneously, at any angle 

of trim (pitching) up to and including 

7.5° by bow or stern. The Coast Guard 

may permit deviations from these angles 

of inclination by considering the type, 

size, and service of intended vessels and 

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considering how the BWMS is to be 

operated. These deviations must be 

included on the certificate issued in 

accordance with § 162.060–10(g) of this 

subpart. 

(b) Each BWMS must have control 

and monitoring equipment that— 

(1) Automatically monitors and 

adjusts necessary treatment dosages, 

intensities, or other aspects required for 

proper operation; 

(2) Incorporates a continuous selfmonitoring function during the period 

in which the BWMS is in operation; 

(3) Records proper functioning and 

failures of the BWMS; 

(4) Records all events in which an 

alarm is activated for the purposes of 

cleaning, calibration, or repair; 

(5) Is able to store data for at least 6 

months and to display or print a record 

for official inspections as required; and 

(6) In the event that the control and 

monitoring equipment is replaced, 

actions must be taken to ensure the data 

recorded prior to replacement remain 

available onboard for a minimum of 24 

months. 

(c) Each BWMS must be designed and 

constructed with the following 

operating and emergency controls: 

(1) Visual means of indicating (both 

on the BWMS and in a normally 

manned space) when the BWMS is 

operating, including a visual alarm 

activated whenever the BWMS is in 

operation for the purpose of cleaning, 

calibration, or repair. 

(2) Audio and visual alarm signals in 

all stations from which ballast water 

operations are controlled in case of any 

failure(s) compromising the proper 

operation of the BWMS. 

(3) Means to activate stop valves, as 

applicable, if the BWMS fails. 

(4) Suitable manual by-passes or 

overrides to protect the safety of the 

vessel and personnel in the event of an 

emergency. 

(5) Means that compensate for a 

momentary loss of power during 

operation of the BWMS so that 

unintentional discharges do not occur. 

(6) Means of automatic operation for 

BWMS installed in unoccupied 

machinery spaces, from the time placed 

on-line until the time secured. 

(7) Adequate alarms for the 

unintentional release of active 

substances, preparations, relevant 

chemicals, or hazardous materials used 

in or produced by the BWMS. 

(d) A BWMS must comply with the 

relevant requirements for use in a 

hazardous location, as defined in 46 

CFR subpart 111.105, or its foreign 

equivalent, if it is intended to be fitted 

in a hazardous location. Any electrical 

equipment that is a component of the 

BWMS must be installed in a nonhazardous location unless certified as 

safe for use in a hazardous location. Any 

moving parts which are fitted in 

hazardous locations must be arranged in 

a manner that avoids the formation of 

static electricity. Certificates issued 

under § 162.060–10(g) for systems 

approved for installation in hazardous 

locations must be so noted. 

(e) To ensure continued operational 

performance of the BWMS without 

interference, the following conditions 

must be incorporated into the design: 

(1) Each part of the BWMS that the 

manufacturer’s instructions require to 

be serviced routinely or that is liable to 

wear or damage must be readily 

accessible in the installed position(s) 

recommended by the manufacturer. 

(2) To avoid interference with the 

BWMS, every access of the BWMS 

beyond the essential requirements, as 

determined by the manufacturer, must 

require the breaking of a seal, and, 

where possible for the purpose of 

maintenance, activate an alarm. 

(3) Simple means must be provided 

aboard the vessel to identify drift and 

repeatability fluctuations and re-zero 

measuring devices that are part of the 

control and monitoring equipment. 

(f) Each BWMS must be designed so 

that it does not rely in whole or in part 

on dilution of ballast water as a means 

of achieving the ballast water discharge 

standard as required in 33 CFR part 151, 

subparts C or D. 

(g) Adequate arrangements for storage, 

application, mitigation, monitoring 

(including alarms), and safe handling 

must be made for all BWMS that 

incorporate the use of, produce, 

generate, or discharge a hazardous 

material, active substance, preparation 

and/or pesticide in accordance with 

Coast Guard regulations on handling/ 

storage of hazardous materials (33 CFR 

part 126) and any other applicable 

Federal, State, and local requirements. 

(h) For any BWMS that incorporates 

the use of or generates active 

substances, preparations, or chemicals, 

the BWMS must be equipped with each 

of the following, as applicable: 

(1) A means of indicating the amount 

and concentration of any chemical in 

the BWMS that is necessary for its 

effective operation. 

(2) A means of indicating when 

chemicals must be added for the proper 

continued operation of the BWMS. 

(3) Sensors and alarms in all spaces 

that may be impacted by a malfunction 

of the BWMS. 

(4) A means of monitoring all active 

substances and preparations and 

relevant chemicals in the treated 

discharge. 

(5) A means to ensure that any 

maximum dosage or maximum 

allowable discharge concentration of 

active substances and preparations is 

not exceeded at any time. 

(6) Proper storage of each chemical 

defined as a hazardous material in 49 

CFR 171.8 that is specified or provided 

by the manufacturer for use in the 

operation of a BWMS. Each such 

chemical that is stowed onboard must 

be labeled and stowed in accordance 

with the procedures in 46 CFR part 147. 

§ 162.060–22 Marking requirements. 

(a) Each ballast water management 

system (BWMS) manufactured for Coast 

Guard approval must have a nameplate 

which is securely fastened to the BWMS 

and plainly marked by the manufacturer 

with the information listed in paragraph 

(b) of this section. 

(b) Each nameplate must include the 

following information: 

(1) Coast Guard approval number 

assigned to the BWMS in the certificate 

of approval. 

(2) Name of the manufacturer. 

(3) Name and model number of the 

BWMS. 

(4) The manufacturer’s serial number 

for the BWMS. 

(5) The month and year of 

manufacture completion. 

(6) The maximum allowable working 

pressure for the BWMS. 

(c) The information required by 

paragraph (b) of this section must 

appear on a nameplate attached to, or in 

lettering on, the BWMS. The nameplate 

or lettering must be capable of 

withstanding the combined effects of 

normal wear and tear and exposure to 

water, salt spray, direct sunlight, heat, 

cold, and any substance used in the 

normal operation and maintenance of 

the BWMS without loss of readability. 

The nameplate must not be obscured by 

paint, corrosion, or other materials that 

would hinder readability. 

§ 162.060–24 Test Plan requirements. 

(a) The Coast Guard requires Test 

Plans for land-based, shipboard, and 

component testing conducted to meet 

the requirements of §§ 162.060–26, 

162.060–28 and 162.060–30 of this 

subpart, respectively. Test Plans must 

include an examination of all the 

manufacturer’s stated requirements and 

procedures for installation, calibration, 

maintenance, and operations that will 

be used by the ballast water 

management system (BWMS) during 

each test, as appropriate for the specific 

test. 

(b) Test Plans must also include 

potential environmental, health, and 

safety issues; unusual operating 

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17316 Federal Register / Vol. 77, No. 57 / Friday, March 23, 2012 / Rules and Regulations 

requirements; and any issues related to 

the disposal of treated ballast water, byproducts, or waste streams. 

(c) For land-based testing, a Test Plan 

prepared under the ETV Protocol may 

be submitted (ETV Protocol 

incorporated by reference, see 

§ 162.060–5). Otherwise, each Test Plan 

must be in the following format: 

(1) Title page, including all project 

participants. 

(2) Table of contents. 

(3) Project description and treatment 

performance objectives. 

(4) Project organization and personnel 

responsibilities. 

(5) Description of the independent 

laboratory and all test facilities and 

subcontractors. 

(6) BWMS description. 

(7) Experimental design (including 

installation/start-up plan for tested 

equipment). 

(8) Challenge conditions and 

preparation (including the test facility’s 

standard operating procedures for 

achieving such conditions). 

(9) Sampling, data acquisition, and 

analysis plan, including all necessary 

procedures. 

(10) Data management, analysis, and 

reporting. 

(11) Quality Assurance Project Plan, 

in accordance with the requirements of 

§ 162.060–36 of this subpart. 

(12) Environmental, health, and safety 

plans. 

(13) Applicable references. 

§ 162.060–26 Land-based testing 

requirements. 

(a) Each ballast water management 

system (BWMS) must undergo landbased tests and evaluations that meet 

the requirements of the ETV Protocol 

(incorporated by reference, see 

§ 162.060–5). The land-based testing 

will determine if the biological efficacy 

of the BWMS under consideration for 

approval is sufficient to meet the 

applicable ballast water discharge 

standard (BWDS) and validate those 

aspects of the operating and 

maintenance parameters presented by 

the manufacturer that are appropriate 

for assessment under the relatively 

short-term, but well-controlled, 

circumstances of a land-based test. 

(b) The test set up must operate as 

described in the ETV Protocol Test Plan 

requirements during at least five 

consecutive, valid, and successful 

replicate test cycles. No adjustments to 

the BWMS are permitted unless 

specifically detailed in the Operation, 

Maintenance and Safety Manual. The 

BWMS must be operated by 

independent laboratory or independent 

laboratory subcontractor personnel. 

(c) Each valid test cycle must 

include— 

(1) Uptake of source water by 

pumping at a minimum of 200 m3/hr; 

(2) Treatment of a minimum of 200 

m3 of challenge water with the BWMS; 

(3) Pumping of a minimum of 200 m3

of control water through the test facility 

in a manner that is in all ways identical 

to paragraph (c)(2) of this section, 

except that the BWMS is not used to 

treat the water; 

(4) Retention of the treated and 

control water in separate tanks for a 

minimum of 24 hours; and 

(5) Discharge of the treated and 

control water by pumping. 

(d) The BWMS must be tested in 

water conditions for which it will be 

approved. For each set of test cycles, a 

salinity range must be chosen. With 

respect to the salinity of water bodies 

where the BWMS is intended to be 

used, the challenge water used in the 

test set-up must have dissolved and 

particulate content as described in the 

ETV Protocol. 

(e) The approval certificate issued in 

accordance with § 162.060–10(g) will 

list the salinity ranges for which the 

BWMS is approved. 

(f) The BWMS must be tested at its 

rated capacity or as specified in 

paragraph (f)(1) of this section for each 

test cycle and must function to the 

manufacturer’s specifications during the 

test. 

(1) Treatment equipment may be 

downsized for land-based testing, but 

only when the following criteria are 

met: 

(i) Treatment equipment with a 

treatment rated capacity (TRC) equal to 

or less than 200 m3/h must not be 

downscaled. 

(ii) Treatment equipment with a TRC 

greater than 200 m3/h but less than 

1,000 m3/h may be downscaled to a 

maximum of 1:5 scale, but must not be 

less than 200 m3/h. 

(iii) Treatment equipment with a TRC 

equal to or greater than 1,000 m3/h may 

be downscaled to a maximum of 1:100 

scale, but must not be less than 200 m3/ 

h. 

(iv) The manufacturer of the BWMS 

must demonstrate by using 

mathematical modeling, computational 

fluid dynamics modeling, and/or by 

calculations, that any downscaling will 

not affect the ultimate functioning and 

effectiveness onboard a vessel of the 

type and size for which the BWMS will 

be approved. 

(2) Greater scaling may be applied and 

lower flow rates used other than those 

described in paragraph (f)(1) of this 

section if the manufacturer can provide 

evidence from full-scale shipboard 

testing, in accordance with paragraph 

(f)(1)(iv) of this section, that greater 

scaling and lower flow rates will not 

adversely affect the testing’s ability to 

predict full-scale compliance with the 

BWDS. The procedures of § 162.060– 

10(b)(1) of this subpart must be followed 

before scaling of flow rates other than 

those provided in paragraph (f)(1) of this 

section may be used. 

(g) The test set-up, TRC, and scaling 

of all tests (including mathematical and 

computational fluid dynamics 

modeling) must be clearly identified in 

the Experimental Design section of the 

Test Plan. 

§ 162.060–28 Shipboard testing 

requirements. 

(a) The ballast water management 

system (BWMS) manufacturer is 

responsible for making all arrangements 

for a vessel on which to conduct 

shipboard tests, including the provision 

and installation of a BWMS. 

(b) Shipboard tests must be conducted 

throughout a period of operation of at 

least 6 months. During the period of 

testing, all ballast water discharged to 

waters of the United States must be 

treated by the BWMS. 

(c) BWMS approved under this 

subpart must undergo shipboard tests 

and evaluations that meet the 

requirements of this section. The 

shipboard testing will verify— 

(1) That the BWMS under 

consideration for approval, when 

installed and operated in the vessel in 

a location and configuration consistent 

with its final intended use on operating 

vessels (e.g., in the engine room or 

pump room), consistently results in the 

routine discharge of ballast water that 

meets the ballast water discharge 

standard (BWDS) requirements of 33 

CFR part 151, subparts C and D; and 

(2) That the operating and 

maintenance parameters identified by 

the manufacturer in the Operation, 

Maintenance, and Safety Manual 

(OMSM) are consistently achieved. 

(d) The BWMS to be tested must be 

installed and operated in the vessel in 

a location and configuration consistent 

with its final intended use on operating 

vessels. Vessel crew must operate the 

BWMS during testing. 

(e) The vessel used as a platform for 

shipboard testing under this section 

must be selected to meet the following 

criteria: 

(1) The volumes and rates of ballast 

water used and treated are 

representative of the upper end of the 

treatment rated capacity for which the 

BWMS is intended to be used. Vessel 

tank size and flow rates must be equal 

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to or exceed those used during landbased tests. 

(2) The circumstances of the vessel’s 

operation during the period of 

shipboard testing provide an acceptable 

range of geographic and seasonal 

variability conditions. 

(i) The source water used for testing 

is representative of harbor or coastal 

waters. Testing must include temperate, 

semi-tropical, or tropical locations with 

ambient organism concentrations that 

will provide a significant challenge to 

the efficacy of the BWMS. 

(ii) Concentrations of organisms 

greater than or equal to 50 micrometers, 

and organisms less than 50 micrometers 

and greater than or equal to 10 

micrometers in the source water must 

exceed 10 times the maximum 

permitted values in the BWDS. 

(3) The ports that the vessel visits 

provide adequate availability of 

transportation and scientific support 

needed to accomplish the necessary 

sampling and analytical procedures 

during the shipboard tests. 

(f) The vessel’s ballast water system 

must be provided with sampling ports 

arranged in order to collect 

representative samples of the vessel’s 

ballast water. In addition to the 

sampling ports designed and installed 

in accordance with the specifications in 

the ETV Protocol (incorporated by 

reference, see § 162.060–5), sampling 

ports must be located— 

(1) As close as practicable to the 

BWMS prior to treatment to determine 

concentrations of living organisms upon 

uptake; 

(2) As close as practicable to the 

BWMS overboard outlet prior to the 

discharge point to determine 

concentrations of living organisms prior 

to discharge; and 

(3) Elsewhere as necessary to 

ascertain the proper functioning of the 

BWMS. 

(g) All test results must be reported in 

accordance with paragraph (i) of this 

section. The efficacy of the BWMS must 

be confirmed during at least five 

consecutive valid test cycles. 

(1) A test cycle entails— 

(i) The uptake of ballast water by the 

vessel; 

(ii) The storage of ballast water on the 

vessel; 

(iii) Treatment of the ballast water by 

the BWMS, except in control tanks, if 

used, with no fine-tuning or adjustment 

of the system except as specifically 

detailed in the OMSM; and 

(iv) The discharge of ballast water 

from the vessel. 

(2) All test cycles must include 

quantification of the water quality 

parameters on uptake. 

(3) All test cycles must include 

discharge tests and quantification of the 

concentration of living organisms in the 

treated ballast water on discharge. 

Sampling and analysis for living 

organisms will be in accordance with 

the ETV Protocol. 

(4) A test cycle must meet the 

following criteria in order to be 

considered valid: 

(i) The uptake of the source water 

must be conducted in accordance with 

paragraph (e)(2)(i) of this section. 

(ii) Source waters must be analyzed 

for organisms greater than or equal to 50 

micrometers and organisms less than 50 

micrometers and greater than or equal to 

10 micrometers. To simplify the testing 

program, these source water samples 

need only be collected and properly 

preserved and transported for counting 

by trained microscopists in land-based 

laboratories. The reported data by taxa 

(to the lowest reasonably identifiable 

taxonomic grouping) will be used to 

characterize the source water biological 

test conditions. 

(iii) The BWMS must operate 

successfully as designed, maintaining 

control of all set points and treatment 

processes, including any pre-discharge 

conditioning to remove or neutralize 

residual treatment chemicals or byproducts. 

(iv) All design or required water 

quality parameters must be met for the 

discharged water. 

(v) Whole effluent toxicity testing 

must be conducted in accordance with 

the December 2008 Environmental 

Protection Agency (EPA) Vessel General 

Permit (VGP) requirements (VGP 

Section 5.8; available at http:// 

www.epa.gov/npdes/pubs/ 

vessel_vgp_permit.pdf). 

(5) The source water for all test cycles 

must be characterized by measurement 

of water quality parameters as follows: 

(i) For all BWMS tests, salinity, 

temperature, and turbidity must be 

measured either continuously during or 

at the beginning, middle, and end of the 

period of ballast water uptake, as 

appropriate and practicable for the 

parameters to be measured. 

(ii) Water quality parameters (e.g., 

dissolved and particulate organic 

material, pH, etc.) that may affect the 

efficacy of BWMS that make use of 

active substances or other processes, or 

water quality parameters identified by 

the manufacturer and/or the 

independent laboratory as being critical, 

must be measured either continuously 

during or at the beginning, middle, and 

end of the period of ballast water 

uptake, as appropriate and practicable 

for the parameters to be measured. 

(h) Samples of ballast water must be 

collected from in-line sampling ports in 

accordance with the sampling 

specifications in the ETV Protocol. 

(i) The following information must be 

documented during the entire period of 

BWMS testing operations conducted on 

the vessel: 

(1) All ballast water operations, 

including volumes and locations of 

uptake and discharge. 

(2) All test cycles, even those in 

which the BWMS failed to meet the 

BWDS, must be documented. The 

possible reasons for an unsuccessful test 

cycle must be investigated and included 

in the Test Report. 

(3) All weather conditions and 

resultant effects on vessel orientation 

and vibration. 

(4) Scheduled maintenance performed 

on the BWMS. 

(5) Unscheduled maintenance and 

repair performed on the BWMS. 

(6) Data for all engineering parameters 

monitored as appropriate to the specific 

BWMS. 

(7) Consumption of all solutions, 

preparations, or other consumables 

necessary for the effective operation of 

the BWMS. 

(8) All parameters necessary for 

tracking the functioning of the control 

and monitoring equipment. 

(9) All instrument calibration 

methods and frequency of calibration. 

(j) All measurements for numbers and 

viability of organisms, water quality 

parameters, engineering performance 

parameters, and environmental 

conditions must be conducted in 

accordance with the ETV Protocol. 

Where alternative methods are 

necessary, given constraints of the 

BWMS and/or the vessel, standard 

methods from recognized bodies such as 

EPA (in 40 CFR part 136), the 

International Standards Organization, or 

others accepted by the scientific 

community must be used, and must be 

accepted in advance by the Coast Guard. 

(k) Test vessels discharging treated 

ballast water into the waters of the 

United States must be enrolled in the 

U.S. Coast Guard’s Shipboard 

Technology Evaluation Program. Test 

vessels discharging treated ballast water 

into waters of other countries must 

secure all necessary approvals and 

permits required for discharges of 

treated ballast water. 

§ 162.060–30 Testing requirements for 

ballast water management system (BWMS) 

components. 

(a) The electrical and electronic 

components, including each alarm and 

control and monitoring device of the 

BWMS, must be subjected to the 

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following environmental tests when in 

the standard production configuration: 

(1) A resonance search vertically up 

and down, horizontally from side to 

side, and horizontally from end to end, 

at a rate sufficiently low as to permit 

resonance detection made over the 

following ranges of oscillation 

frequency and amplitude: 

(i) At 2 to 13.3 Hz with a vibration 

amplitude of +/¥1 mm. 

(ii) At 13.2 to 80 Hz with an 

acceleration amplitude of +/¥ 0.7 g. 

(2) The components must be vibrated 

in the planes specified in paragraph 

(a)(1) of this section at each major 

resonant frequency for a period of 4 

hours. 

(3) In the absence of any resonant 

frequency, the components must be 

vibrated in each of the planes specified 

in paragraph (a)(1) of this section at 30 

Hz with an acceleration of +/¥ 0.7 g for 

a period of 4 hours. 

(4) Components that may be installed 

in exposed areas on the open deck or in 

enclosed spaces not environmentally 

controlled must be subjected to a low 

temperature test of ¥25° C and a high 

temperature test of 55° C for a period of 

2 hours at each temperature. At the end 

of each test, the components are to be 

switched on and must function 

normally under the test conditions. 

(5) Components that may be installed 

in enclosed spaces that are 

environmentally controlled, including 

an engine room, must be subjected to a 

low temperature test at 0° C and a high 

temperature test at 55° C, for a period 

of 2 hours at each temperature. At the 

end of each test, the components are to 

be switched on and must function 

normally under the test conditions. 

(6) Components must be switched off 

for a period of 2 hours at a temperature 

of 55° C in an atmosphere with a 

relative humidity of 90 percent. At the 

end of this period, the components must 

be switched on and must operate 

satisfactorily for 1 hour under the test 

conditions. 

(7) Components that may be installed 

in exposed areas on the open deck must 

be subjected to tests for protection 

against heavy seas in accordance with IP 

56 of publication IEC 60529 

(incorporated by reference, see 

§ 162.060–5) or its equivalent. 

(8) Components must operate 

satisfactorily with a voltage variation of 

+/¥ 10 percent together with a 

simultaneous frequency variation of +/ 

¥ 5 percent, and a transient voltage of 

+/¥ 20 percent together with a 

simultaneous transient frequency of +/ 

¥ 10 percent and transient recovery 

time of 3 seconds. 

(9) The components of a BWMS must 

be designed to operate when the vessel 

is upright and inclined at any angle of 

list up to and including 15° either way 

under static conditions and 22.5° under 

dynamic, rolling conditions either way 

and simultaneously inclined 

dynamically (pitching) 7.5° by bow or 

stern. Deviation from these angles may 

be permitted only upon approval of a 

written waiver submitted to the Coast 

Guard in accordance with § 162.060– 

10(b)(1) of this subpart, taking into 

consideration the type, size, and service 

conditions and locations of the vessels 

and operational functioning of the 

equipment for where the system will be 

used. Any deviation permitted must be 

documented in the type-approval 

certificate. 

(10) The same component(s) must be 

used for each test required by this 

section and testing must be conducted 

in the order in which the tests are 

described, unless otherwise authorized 

by the Coast Guard. 

(b) There must be no cracking, 

softening, deterioration, displacement, 

breakage, leakage, or damage of 

components or materials that affect the 

operation or safety of the BWMS after 

each test. The components must remain 

operable after all tests. 

§ 162.060–32 Testing and evaluation 

requirements for active substances, 

preparations, and relevant chemicals. 

(a) A ballast water management 

system (BWMS) may not use an active 

substance or preparation that is a 

pesticide unless the sale and 

distribution of such pesticide is 

authorized under the Federal 

Insecticide, Fungicide, and Rodenticide 

Act (FIFRA) for use in ballast water 

treatment prior to submission to the 

Coast Guard for approval of the BWMS. 

This requirement does not apply to the 

use of active substances or preparations 

generated solely by the use of a device 

(as defined under FIFRA) onboard the 

same vessel as the ballast water to be 

treated. 

(b) The manufacturer of a BWMS that 

uses an active substance or preparation 

that is not a pesticide, or that uses a 

pesticide that is generated solely by the 

use of a device (as defined under 

FIFRA) onboard the same vessel as the 

ballast water to be treated, must prepare 

an assessment demonstrating the 

effectiveness of the BWMS for its 

intended use, appropriate dosages over 

all applicable temperatures, hazards of 

the BWMS, and means for protection of 

the environment, and public health. 

This assessment must accompany the 

application package submitted to the 

Coast Guard. 

§ 162.060–34 Test Report requirements. 

The Test Report prepared and 

submitted by an independent laboratory 

must be formatted as set out below. The 

Test Report must include, in addition to 

the information required by 46 CFR 

159.005–11, information as follows: 

(a) Summary statement with the 

following information: 

(1) Name of the independent 

laboratory (IL) and all test facilities, 

subcontractors, and test organizations 

involved in testing the ballast water 

management system (BWMS). 

(2) Name of manufacturer. 

(3) BWMS model name. 

(4) The IL’s assessment that the 

BWMS— 

(i) Has demonstrated, under the 

procedures and conditions specified in 

this subpart for both land-based and 

shipboard testing, that it meets the 

ballast water discharge standard 

requirements of 33 CFR part 151, 

subparts C and D; 

(ii) Is designed and constructed 

according to the requirements of 

§ 162.060–20 of this subpart; 

(iii) Is in compliance with all 

applicable U.S. Environmental 

Protection Agency (EPA) requirements; 

(iv) Operates at the rated capacity, 

performance, and reliability as specified 

by the manufacturer; 

(v) Contains control and monitoring 

equipment that operates correctly; 

(vi) Was installed in accordance with 

the technical installation specification 

of the manufacturer for all tests; and 

(vii) Was used to treat volumes and 

flow rates of ballast water during the 

shipboard tests consistent with the 

normal ballast operations of the vessel. 

(b) Executive summary. 

(c) Introduction and background. 

(d) Description of the BWMS. 

(e) For each test conducted, summary 

descriptions of— 

(1) Test conditions; 

(2) Experimental design; 

(3) Methods and procedures; and 

(4) Results and discussion. 

(f) Appendices, including— 

(1) Complete Test Plans for landbased, shipboard, and component tests, 

for which an EPA Environmental 

Technology Verification (ETV) 

Verification Report produced in 

accordance with the ETV Protocol can 

substitute for the land-based test plan; 

(2) Manufacturer supplied Operation, 

Maintenance, and Safety Manual that 

meets the requirements of § 162.060–38 

of this subpart; 

(3) Data generated during testing and 

evaluations; 

(4) Quality Assurance and Quality 

Control records; 

(5) Maintenance logs; 

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(6) Relevant records and tests results 

maintained or created during testing; 

(7) Information on hazardous 

materials, active substances, relevant 

chemicals, and pesticides as detailed in 

paragraph (g) of this section; and 

(8) Permits, registrations, restrictions, 

and regulatory limitations on use. 

(g) The Test Report for a BWMS that 

may incorporate, use, produce, generate 

as a by-product and/or discharge 

hazardous materials, active substances, 

relevant chemicals and/or pesticides 

during its operation must include the 

following information in the appendix 

of the Test Report: 

(1) A list of each active substance or 

preparation used in the BWMS. For 

each active substance or preparation 

that is a pesticide and is not generated 

solely by the use of a device onboard the 

same vessel as the ballast water to be 

treated, the appendix must also include 

documentation that the sale or 

distribution of the pesticide is 

authorized under the Federal 

Insecticide, Fungicide, and Rodenticide 

Act for use for ballast water treatment. 

For all other active substances or 

preparations, the appendix must 

include documentation of the 

assessment specified in § 162.060–32(b) 

of this subpart. 

(2) A list of all hazardous materials, 

including the applicable hazard classes, 

proper shipping names, reportable 

quantities as designated by 40 CFR 

117.1, and chemical names of all 

components. 

§ 162.060–36 Quality Assurance Project 

Plan (QAPP) requirements. 

The approval testing and evaluation 

process must contain a rigorous Quality 

Assurance and Quality Control program 

consisting of a QAPP developed in 

accordance with ISO/IEC 17025:2005(E), 

as amended ISO/IEC 17025:2005/ 

Cor.1:2006(E) (incorporated by 

reference, see § 162.060–5). The 

independent laboratory performing 

approval tests and evaluations is 

responsible for ensuring the appropriate 

Quality Assurance and Quality Control 

procedures are implemented. 

§ 162.060–38 Operation, Maintenance, and 

Safety Manual (OMSM). 

(a) Each OMSM must include the 

following sections: 

(1) Table of contents. 

(2) Manufacturer’s information. 

(3) Principles of ballast water 

management system (BWMS) operation, 

including— 

(i) A complete description of the 

BWMS, methods and type(s) of 

technologies used in each treatment 

stage of the BWMS; 

(ii) The theory of the BWMS’ 

operation; 

(iii) Any process or technology 

limitations of the BWMS; 

(iv) Performance ranges and 

expectations of the system; and 

(v) A description of the locations and 

conditions for which the BWMS is 

intended. 

(4) Major system components and 

shipboard application, including— 

(i) A general description of the 

materials used for construction and 

installation of the BWMS; 

(ii) A list of each major component 

that may be fitted differently in different 

vessels with a general description of the 

different arrangements schemes; 

(iii) Any vessel type(s), services, or 

locations where the BWMS is not 

intended to be used; 

(iv) Maximum and minimum flow 

and volume capacities of the BWMS; 

(v) The dimensions and weight of the 

complete BWMS and required 

connection and flange sizes for all major 

components; 

(vi) A description of all actual or 

potential effects of the BWMS on the 

vessel’s ballast water, ballast water 

tanks, and ballast water piping and 

pumping systems; 

(vii) A list of all active substances, 

relevant chemicals, and pesticides 

generated or stored onboard the vessel 

to be used by the BWMS; and 

(viii) Information on whether the 

BWMS is designed to be used in 

hazardous locations. 

(5) System and major system 

component drawings as applicable, 

including— 

(i) Process flow diagram(s) of the 

BWMS showing the main treatment 

processes, chemicals, and monitoring 

and control devices for the BWMS; 

(ii) Footprint(s), drawings, and system 

schematics showing all major 

components and arrangements; 

(iii) Drawings, containing a bill of 

materials, for the pumping and piping 

arrangements, and all related equipment 

provided with the BWMS; 

(iv) All treatment application points, 

waste or recycling streams, and all 

sampling points integral to the BWMS; 

(v) All locations and the sizes of all 

piping and utility connections for 

power, water, compressed air or other 

utilities as required by the BWMS; 

(vi) Electrical wiring diagrams that 

include the location and electrical rating 

of power supply panels and BWMS 

control and monitoring equipment; 

(vii) Unit(s), construction materials, 

standards, and labels on all drawings of 

equipment, piping, instruments, and 

appurtenances; and 

(viii) An index of all drawings and 

diagrams. 

(6) A description of the BWMS’s 

control and monitoring equipment and 

how it will be integrated with the 

existing shipboard ballast system, 

including— 

(i) Power demand; 

(ii) Main and local control panels; 

(iii) Power distribution system; 

(iv) Power quality equipment; 

(v) Instrumentation and control 

system architecture; 

(vi) Process control description; 

(vii) Operational set points, control 

loops, control algorithms, and alarm 

settings for routine maintenance, and 

emergency operations; and 

(viii) All devices required for 

measuring appropriate parameters, such 

as pressure, temperature, flow rate, 

water quality, power, and chemical 

residuals. 

(7) A description of all relevant 

standard operating procedures 

including, but not limited to— 

(i) BWMS start-up and shutdown 

procedures and times; 

(ii) Emergency shutdown and system 

by-pass procedures; 

(iii) Requirements to achieve 

treatment objectives (e. g., time 

following initial treatment, critical 

dosages, residual concentrations, etc); 

(iv) Operating, safety, and emergency 

procedures; 

(v) BWMS limitations, precautions, 

and set points; 

(vi) Detailed instructions on 

operation, calibration and zeroing of 

each monitoring device used with the 

BWMS; and 

(vii) Personnel requirements for the 

BWMS, including number and types of 

personnel needed, labor burden, and 

operator training or specialty 

certification requirements. 

(8) A description of the preventive 

and corrective maintenance 

requirements of the BWMS, including— 

(i) Inspection and adjustment 

procedures; 

(ii) Troubleshooting procedures; 

(iii) An illustrated list of parts and 

spare parts; 

(iv) A list of recommended spare parts 

to have during installation and 

operation of the BWMS; 

(v) Use of tools and test equipment in 

accordance with the maintenance 

procedures; and 

(vi) Point(s) of contact for technical 

assistance. 

(9) A description of the health and 

safety risks to the personnel associated 

with the installation, operation, and 

maintenance of the BWMS including, 

but not limited to— 

(i) The storage, handling, and disposal 

of any hazardous wastes; 

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(ii) Any health and safety 

certification/training requirements for 

personnel operating the BWMS; and 

(iii) All material safety data sheets for 

hazardous or relevant chemicals used, 

stored, or generated by or for the system. 

(b) If any information in the OMSM 

changes as a result of approval testing 

and evaluations, a new OMSM must be 

submitted. 

§ 162.060–40 Requirements for 

Independent Laboratories (ILs). 

(a) For designation by the Coast Guard 

as an independent laboratory for the 

evaluation, inspection, and testing of 

BWMS, an independent laboratory must 

demonstrate compliance with 46 CFR 

159.010–3, 46 CFR 159.010–5, and 46 

CFR 159.010–11 through 159.010–19. 

(b) Each request for designation as an 

independent laboratory authorized 

under paragraph (a) of this section must 

be delivered to the Commandant (CG– 

521), Office of Design and Engineering 

Standards, U.S. Coast Guard, 2nd St. 

SW., Stop 7126, Washington, DC 20593– 

7126, in a written or electronic format. 

(c) A list of independent laboratories 

designated by the Coast Guard under 

paragraph (b) of this section may be 

found at http://cgmix.uscg.mil/, or may 

be obtained by contacting the 

Commandant (CG–521), Office of Design 

and Engineering Standards, U.S. Coast 

Guard, 2100 2nd St. SW., Stop 7126, 

Washington, DC 20593–7126. 

§ 162.060–42 Responsibilities for 

Independent Laboratories (ILs). 

(a) Upon receipt of a request from a 

manufacturer for approval testing of a 

ballast water management system 

(BWMS), the independent laboratory 

will conduct a readiness evaluation and 

determine the acceptability of the 

BWMS for testing. 

(1) The readiness evaluation will 

examine the design and construction of 

the BWMS to determine whether there 

are any fundamental problems that 

might constrain the ability of the BWMS 

to manage ballast water as proposed by 

the manufacturer or to operate it safely 

onboard vessels. This evaluation must 

determine that the BWMS— 

(i) Is designed and constructed 

according to the requirements of 

§ 162.060–20 of this subpart; 

(ii) Meets all existing safety and 

environmental regulatory requirements 

for all locations and conditions where 

the system will be operated during the 

testing and evaluation period; and 

(iii) Meets the definition of a complete 

BWMS, as defined in this subpart, to 

include both ballast water treatment 

equipment and control and monitoring 

equipment. Only complete systems in 

the configurations in which they are 

intended for sale and use will be 

accepted for type-approval testing. 

(2) The independent laboratory has 

the right to reject a proposed BWMS for 

type-approval testing if it does not 

satisfy the requirements in paragraph (b) 

of this section, is not deemed ready for 

approval testing or if, for technical or 

logistical reasons, that independent 

laboratory does not have the capability 

to accommodate the BWMS for testing 

or evaluation. 

(3) Upon determination that the 

BWMS is ready for testing, the 

independent laboratory will notify the 

Commandant (CG–52), Commercial 

Regulations and Standards Directorate, 

2100 2nd St. SW., Stop 7126, 

Washington, DC 20593–7126, and 

provide the estimated date for 

commencement of type-approval 

testing. 

(b) The independent laboratory must 

prepare a written Test Plan for each 

approval test to be completed, in 

accordance with § 162.060–24 of this 

subpart. 

(c) Prior to land-based testing, the 

independent laboratory must ensure 

that the BWMS supplied by the 

manufacturer is set up in accordance 

with the BWMS’ Operation, 

Maintenance, and Safety Manual 

(OMSM). 

(d) Prior to shipboard testing, the 

independent laboratory must ensure 

that the BWMS supplied by the 

manufacturer is installed in a vessel in 

accordance with the OMSM and the 

vessel’s administration’s requirements 

and can be tested in accordance with 

§ 162.060–28 of this subpart. 

(e) Prior to commencing land-based or 

shipboard testing required under this 

subpart, the independent laboratory 

must require the BWMS manufacturer to 

sign a written statement to attest that the 

system was properly assembled and 

installed at the test facility or onboard 

the test vessel. 

(f) The independent laboratory or its 

subcontractor(s) must conduct all 

approval testing and evaluations in 

accordance with testing requirements of 

this subpart and within the range or 

rated capacity of the BWMS. 

(g) Upon completion of all approval 

tests and evaluations, the independent 

laboratory must follow the requirements 

of § 162.060–34 of this subpart and 

forward a complete Test Report to the 

Commanding Officer, U.S. Coast Guard 

Marine Safety Center, 2100 2nd St. SW., 

Stop 7102, Washington, DC 20593– 

7102, or by email to msc@uscg.mil. 

Dated: March 9, 2012. 

Robert J. Papp Jr., 

Admiral, U.S. Coast Guard, Commandant. 

[FR Doc. 2012–6579 Filed 3–16–12; 11:15 am] 

BILLING CODE 9110–04–P 

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