Document ID: USCG-2001-10486-0476
Agency: uscg
Document Type: Rule
Title: FR:  Standards for Living Organisms in Ships' Ballast Water Discharged in U.S. Waters (Federal Register Publication)
Posted Date: 2012-03-23T04:00Z

[Federal Register Volume 77, Number 57 (Friday, March 23, 2012)]
[Rules and Regulations]
[Pages 17254-17320]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-6579]

[[Page 17253]]

Vol. 77

Friday,

No. 57

March 23, 2012

Part V

Department of Homeland Security

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Coast Guard

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33 CFR Part 151

46 CFR Part 162

 Standards for Living Organisms in Ships' Ballast Water Discharged in 
U.S. Waters; Final Rule

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

[[Page 17254]]

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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.

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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

[[Page 17255]]

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.
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    \1\ Copies 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.
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    For these reasons, BWE is not well-suited 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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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.
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    \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).
    \3\ Section 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 * * *.''
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    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 
phase-two 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 
land-based 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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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 phase-one 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

[[Page 17258]]

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 
Sec.  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.
---------------------------------------------------------------------------

    \4\ EPA/600/R-10/146, version 5.1 (September 2010). Available at 
http://www.epa.gov/nrmrl/pubs/600r10146/600r10146.pdf.
---------------------------------------------------------------------------

    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.
---------------------------------------------------------------------------

    \5\ See 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).
---------------------------------------------------------------------------

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

[[Page 17259]]

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 (Sec.  
151.2026) and definition (Sec.  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 Sec.  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 land-based 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

[[Page 17260]]

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 Sec.  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 Sec.  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 non-repetitive 
provision to Sec.  151.2040. As a result, Sec.  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 cross-references 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

[[Page 17261]]

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 barge-based 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

[[Page 17262]]

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, 
concentration-based 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 
phase-two 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 phase-one 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

[[Page 17263]]

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. type-approval 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 long-term 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 zero-discharge 
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 phase-two 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 phase-
one 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 phase-one 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 phase-one 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

[[Page 17264]]

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 phase-two 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 phase-one. 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 phase-two 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 phase-two standard 
should not have a defined value before the results of the 
practicability review are known.
    One commenter opposed the phase-two 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 phase-two 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 phase-two 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 cost-effective 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

[[Page 17265]]

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 phase-two 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 phase-two 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., 
ocean-going 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 phase-two 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 phase-two 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

[[Page 17266]]

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 phase-
two 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,

[[Page 17267]]

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 Sec.  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 phase-one 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 un-exchanged 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 bi-national 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

[[Page 17268]]

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 phase-two 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 phase-two 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 bi-national 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 Sec.  151.2040. As a result, Sec.  
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 Sec.  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

[[Page 17269]]

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

[[Page 17270]]

Guard for type approval. Discharges from vessels with systems using 
non-pesticide 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 type-approval 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

[[Page 17271]]

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 type-approved BWMS to submit data 
developed during the foreign type-approval 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 land-based 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, [mu]m) 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

[[Page 17272]]

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 type-approved 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

[[Page 17273]]

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 type-approval 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.

[[Page 17274]]

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 m\3\ for phase one and 1 
organism larger than 50 micrometers per m\3\ 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 m\3\ of water for all trials, with at least three 
trials having more than 100,000 organisms per m\3\ of water; 1,000 
organisms per m\3\ 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 m\3\ 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

[[Page 17275]]

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 land-based 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 m\3\ 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

[[Page 17276]]

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 
in-tank (batch) treatments, and specifically proposed that a maximum of 
10 m\3\ of water would be sufficient. The Coast Guard disagrees. The 
requirement for a minimum of 200 m\3\ 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 type-approval 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 land-based 
testing.
    Two submitters commented generally on the inclusion of a 
requirement for

[[Page 17277]]

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

[[Page 17278]]

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 case-by-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 re-certification 
is necessary. The Coast Guard disagrees. Under the existing process for 
type approvals, all changes to the design or construction of type-
approved equipment must be submitted to the Coast Guard for review.
    One commenter recommended that documentation submitted for type

[[Page 17279]]

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 type-
approved 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

[[Page 17280]]

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

[[Page 17281]]

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 phase-
two 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.

[[Page 17282]]

    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 court-
ordered 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 
phase-two 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 phase-two 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.

[[Page 17283]]

    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 non-commercial 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

[[Page 17284]]

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. flagged-vessels 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 
phase-two 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

[[Page 17285]]

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 m\3\ and 1,500 m\3\ 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

[[Page 17286]]

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

[[Page 17287]]

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 single-species 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

[[Page 17288]]

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 phase-one 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

[[Page 17289]]

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 all-inclusive. 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

[[Page 17290]]

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 well-known and others can easily be determined 
experimentally. The second

[[Page 17291]]

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,

[[Page 17292]]

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 
over-inclusive (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

[[Page 17293]]

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 no-action 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

[[Page 17294]]

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. type-approved BWMS intended 
for use onboard vessels that can practicably and safely achieve 
complete sterilization of ballast water. Although difficult, the Coast 
Guard made a scientifically-founded 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 long-term 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 phase-one 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

[[Page 17295]]

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

[[Page 17296]]

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 m\3\ 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

[[Page 17297]]

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 foreign-flagged 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 mid-ocean 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

[[Page 17298]]

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-to-Know 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 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. 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.

[[Page 17299]]

    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 phase-two 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 vessel-mediated 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

[[Page 17300]]

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           Oceangoing vessels
                               discharging ballast   and some coastwise
                               water into U.S.       vessels (>1,600 GT)
                               waters.               discharging ballast
                                                     water in U.S.
                                                     waters.
Compliance Start Date.......  Beginning 2012......  Revised, beginning
                                                     2013.
Number of BWMS Installations  4,758...............  3,046.
 on Vessels (10-year period
 of analysis).
Costs ($ millions,7 percent   $167 (annualized)...  $92 (annualized).
 discount rate).              $1,176 (10-year)....  $649 (10-year).
Benefits ($ millions,7        $165-$282             $141-$240
 percent discount rate).       (annualized).         (annualized)
                              $1,161-$1,977 (10-    $989-$1,684 (10-
                               year)..               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 foreign-
flagged vessels are expected to comply pursuant to the IMO BWM 
Convention, which is the phase-one BWDS.\7\
---------------------------------------------------------------------------

    \6\ This 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.
    \7\ Foreign 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.
---------------------------------------------------------------------------

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.
---------------------------------------------------------------------------

    \8\ Cost 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.
---------------------------------------------------------------------------

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.

[[Page 17301]]

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.
---------------------------------------------------------------------------

    \9\ 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.
---------------------------------------------------------------------------

    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.

[[Page 17302]]

    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.
---------------------------------------------------------------------------

    \10\ Sources: 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.
---------------------------------------------------------------------------

    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 
Sec.  151.2030.
    Any extension request must be made no later than 12 months before 
the scheduled implementation date listed in Sec.  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 x 8 hours for completing and submitting the extension 
documentation). The total burden cost is $141,328, calculated by (a) + 
(b):
---------------------------------------------------------------------------

    \11\ This 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.

    (a) Assuming someone at a management level (equivalent to GS-12 
(out-of-government 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 x 6 
hrs x 292 vessels = $120,888.
---------------------------------------------------------------------------

    \12\ Wage 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).
---------------------------------------------------------------------------

    (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 x 2hrs x 292 vessels = 
$20,440.
---------------------------------------------------------------------------

    \13\ Wage rate obtained from Enclosure (2) to COMDTINST 7310.1M 
and validated based on the Bureau of Labor Statistics (BLS) 
subcategory First-line Supervisor of office and Administrative 
Support Worker (Occupation Code 43-1011).

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

[[Page 17303]]

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).
---------------------------------------------------------------------------

    \14\ The 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/).
---------------------------------------------------------------------------

    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:

[[Page 17304]]

    (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

0
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.

0
2. Revise Sec.  151.1502 to read as follows:

Sec.  151.1502  Applicability.

    This subpart applies to all non-recreational 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.

0
3. In Sec.  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:

Sec.  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.
* * * * *

0
4. Add new Sec.  151.1505 to read as follows:

Sec.  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.

0
5. In Sec.  151.1510--
0
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:

Sec.  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 Sec.  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 Sec.  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 Sec.  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 Sec.  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.

[[Page 17305]]

    (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 Sec.  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 Sec.  151.1511 of this subpart, at 
all times of ballast water discharge into the waters of the United 
States.

0
6. Add new Sec.  151.1511 to read as follows:

Sec.  151.1511  Ballast water discharge standard (BWDS).

    (a) Vessels employing a Coast Guard-approved ballast water 
management system (BWMS) must meet the following BWDS by the date in 
Sec.  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.

Sec.  151.1512 and 151.1514   [Redesignated as Sec. Sec.  151.1514 and 
151.1515]

0
7. Redesignate Sec. Sec.  151.1512 and 151.1514 as Sec. Sec.  151.1514 
and 151.1515, respectively.

0
8. Add a new Sec.  151.1512 to read as follows:

Sec.  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 Sec.  151.1510 of this subpart must either 
ensure that the ballast water meets the ballast water discharge 
standard as defined in Sec.  151.1511(a), use an AMS as provided for 
under Sec.  151.1510(a)(1) or ballast exclusively with water from a 
U.S. public water system, as described in Sec.  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 USCG-

[[Page 17306]]

approved BWMS and comply with the discharge standard, or employ an 
approved alternative ballast water management method per Sec.  
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    On delivery.
                                                              1, 2013.
Existing vessels...................  Less than 1500 m\3\...  Before December 1,      First scheduled drydocking
                                                              2013.                   after January 1, 2016.
                                     1500-5000 m\3\........  Before December 1,      First scheduled drydocking
                                                              2013.                   after January 1, 2014.
                                     Greater than 5000 m\3\  Before December 1,      First scheduled drydocking
                                                              2013.                   after January 1, 2016.
----------------------------------------------------------------------------------------------------------------

0
9. Add new Sec.  151.1513 to read as follows:

Sec.  151.1513  Extension of Compliance Date.

    The Coast Guard may grant an extension to the implementation 
schedule in Sec.  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 Sec.  151.1510 is not possible. 
Any extension request must be made no later than 12 months before the 
scheduled implementation date listed in Sec.  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 Sec.  
151.1510.

0
10. Revise newly redesignated Sec.  151.1515 as follows:

Sec.  151.1515  Ballast water management alternatives under 
extraordinary conditions.

    (a) As long as ballast water exchange (BWE) remains an option under 
the schedule in Sec.  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 Sec.  
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.

0
11. Revise Sec.  151.1516(a) to read as follows:

Sec.  151.1516  Compliance Monitoring.

    (a) The master of each vessel equipped with ballast tanks must 
provide, as detailed in Sec.  151.2070 of this part, the following 
information, in written form, to the Captain of the Port (COTP):
* * * * *

0
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

Sec.  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.

Sec.  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

[[Page 17307]]

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.

Sec.  151.2010  Applicability.

    This subpart applies to all non-recreational 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 Sec. Sec.  
151.2015 or 151.2020 of this subpart.

Sec.  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.

Sec.  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 
non-commercial 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 
Sec. Sec.  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 
Sec.  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.

Sec.  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.

Sec.  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 Sec.  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 Sec.  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 Sec.  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 
Sec.  151.2035(b) of this subpart. An alternate management system (AMS) 
that meets the requirements of Sec.  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 
Sec.  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

[[Page 17308]]

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 Sec.  
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 Sec. Sec.  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.

Sec.  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 Sec.  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 
Sec.  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.

Sec.  151.2030  Ballast water discharge standard (BWDS).

    (a) Vessels employing a Coast Guard-approved ballast water 
management system (BWMS) must meet the following BWDS by the date 
listed in Sec.  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

[[Page 17309]]

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.

Sec.  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 Sec.  151.2025 of this subpart must either ensure that the 
ballast water meets the ballast water discharge standard as defined in 
Sec.  151.2030(a), use an AMS as described in Sec.  151.2025(a)(3) or 
ballast with water from a U.S. public water system, as described in 
Sec.  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 USCG-approved BWMS and 
comply with the discharge standard, use PWS per Sec.  151.2025(a)(2), 
or use a previously installed AMS per Sec.  151.2025(a)(3).

            Table 151.2035(b)--Implementation Schedule for Approved Ballast Water Management Methods
----------------------------------------------------------------------------------------------------------------
                                       Vessel's ballast  water                             Vessel's compliance
                                               capacity             Date constructed               date
----------------------------------------------------------------------------------------------------------------
New vessels..........................  All....................  On or after December 1,  On delivery.
                                                                 2013.
Existing vessels.....................  Less than 1500 m\3\....  Before December 1, 2013  First scheduled
                                                                                          drydocking after
                                                                                          January 1, 2016.
                                       1500-5000 m\3\.........  Before December 1, 2013  First scheduled
                                                                                          drydocking after
                                                                                          January 1, 2014.
                                       Greater than 5000 m\3\.  Before December 1, 2013  First scheduled
                                                                                          drydocking after
                                                                                          January 1, 2016.
----------------------------------------------------------------------------------------------------------------

Sec.  151.2036  Extension of compliance date.

    The Coast Guard may grant an extension to the implementation 
schedule listed in Sec.  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 Sec.  
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 Sec.  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 Sec.  151.2030.

Sec.  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 Sec.  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 Sec.  
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

[[Page 17310]]

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 Sec.  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 Sec.  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.

Sec.  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 bottom-dwelling 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.

Sec.  151.2055  Deviation from planned voyage.

    As long as ballast water exchange (BWE) is an allowable ballast 
water management option under Sec. Sec.  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 Sec.  151.2040(b) of this 
subpart.

Sec.  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 Sec.  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 Sec.  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.

[[Page 17311]]

    (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.

Sec.  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 Sec.  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 
Sec.  151.2060 of this subpart; and
    (b) Compliance with Sec.  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.

Sec.  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 Sec.  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 (m\3\), 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 
Sec.  151.2025(c) of this subpart and 33 CFR part 151 subpart C.

Sec.  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 Sec.  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.

Sec.  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]

0
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

0
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.

[[Page 17312]]

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

Sec.  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.

Sec.  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-for-profit 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.

Sec.  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.

[[Page 17313]]

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 Sec.  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 Sec.  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 Sec.  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 Sec. Sec.  162.060-26 and 162.060-28 (ETV 
Protocol).
    (2) [Reserved]

Sec.  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 Sec. Sec.  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 Sec.  162.060-14 of this subpart.
    (d) Upon receipt of an application completed in compliance with 
Sec.  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 Sec.  
162.060-20 of this subpart;
    (2) It is evaluated, inspected, and tested under land-based and 
shipboard conditions in accordance with Sec. Sec.  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 Sec.  162.060-30 of this subpart;
    (4) The BWMS meets the requirements of Sec.  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.

Sec.  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 Sec.  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 Sec.  162.060-
10(a) of this subpart for testing that has already occurred; or with 
the requirements that

[[Page 17314]]

all evaluation, inspection, and testing of the BWMS is conducted by an 
independent laboratory, previously accepted by the Coast Guard, under 
Sec.  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 Sec.  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 Sec.  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.

Sec.  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 Sec.  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 Sec.  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.

Sec.  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.

Sec.  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.

Sec.  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[deg], and when 
the vessel is inclined under dynamic, rolling conditions at any angle 
of list up to and including 22.5[deg] and, simultaneously, at any angle 
of trim (pitching) up to and including 7.5[deg] 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

[[Page 17315]]

considering how the BWMS is to be operated. These deviations must be 
included on the certificate issued in accordance with Sec.  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 self-monitoring 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 non-hazardous 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 Sec.  
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.

Sec.  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.

Sec.  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 Sec. Sec.  
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

[[Page 17316]]

requirements; and any issues related to the disposal of treated ballast 
water, by-products, 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 
Sec.  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 Sec.  162.060-36 of this subpart.
    (12) Environmental, health, and safety plans.
    (13) Applicable references.

Sec.  162.060-26  Land-based testing requirements.

    (a) Each ballast water management system (BWMS) must undergo land-
based tests and evaluations that meet the requirements of the ETV 
Protocol (incorporated by reference, see Sec.  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 m\3\/hr;
    (2) Treatment of a minimum of 200 m\3\ of challenge water with the 
BWMS;
    (3) Pumping of a minimum of 200 m\3\ 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 Sec.  
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 m\3\/h must not be downscaled.
    (ii) Treatment equipment with a TRC greater than 200 m\3\/h but 
less than 1,000 m\3\/h may be downscaled to a maximum of 1:5 scale, but 
must not be less than 200 m\3\/h.
    (iii) Treatment equipment with a TRC equal to or greater than 1,000 
m\3\/h may be downscaled to a maximum of 1:100 scale, but must not be 
less than 200 m\3\/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 Sec.  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.

Sec.  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

[[Page 17317]]

to or exceed those used during land-based 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 Sec.  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 by-products.
    (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.

Sec.  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

[[Page 17318]]

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[deg] C and a high 
temperature test of 55[deg] 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[deg] C and a high temperature test at 
55[deg] 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[deg] 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 Sec.  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[deg] either way under static conditions and 22.5[deg] under dynamic, 
rolling conditions either way and simultaneously inclined dynamically 
(pitching) 7.5[deg] 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 Sec.  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.

Sec.  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.

Sec.  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 
Sec.  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 land-based, 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 Sec.  162.060-38 of this subpart;
    (3) Data generated during testing and evaluations;
    (4) Quality Assurance and Quality Control records;
    (5) Maintenance logs;

[[Page 17319]]

    (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 Sec.  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.

Sec.  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 Sec.  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.

Sec.  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;

[[Page 17320]]

    (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.

Sec.  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.

Sec.  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 
Sec.  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 Sec.  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 Sec.  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 Sec.  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