[Federal Register: August 28, 2009 (Volume 74, Number 166)]
[Proposed Rules]
[Page 44631-44672]
[DOCID:fr28au09-27]

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Part IV

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; Draft Programmatic Environmental Impact Statement;
Proposed Rule and Notice

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 151

46 CFR Part 162

[USCG-2001-10486]
RIN 1625-AA32

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

AGENCY: Coast Guard, DHS.

ACTION: Notice of proposed rulemaking.

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SUMMARY: The Coast Guard proposes to amend its regulations on ballast
water management by establishing standards for the allowable
concentration of living organisms in ships' ballast water discharged in
U.S. waters. The Coast Guard also proposes to amend its regulations for
approving engineering equipment by establishing an approval process for
ballast water management systems. These new regulations would aid in
controlling the introduction and spread of nonindigenous species from
ships discharging ballast water in U.S. waters.

DATES: Comments and related material must either be submitted to our
online docket via http://www.regulations.gov on or before November 27,
2009 or reach the Docket Management Facility by that date.

ADDRESSES: You may submit comments identified by Coast Guard docket
number USCG-2001-10486 to the Docket Management Facility at the U.S.
Department of Transportation. To avoid duplication, please use only one
of the following methods:
    (1) Federal eRulemaking Portal: http://www.regulations.gov.
    (2) Mail: Docket Management Facility (M-30), U.S. Department of
Transportation, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue, SE., Washington, DC 20590-0001.
    (3) Hand delivery: 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. The telephone
number is<PHONE_NUMBER>.
    (4) Fax:<PHONE_NUMBER>.
    To avoid duplication, please use only one of these four methods.
See the ``Public Participation and Request for Comments'' portion of
the SUPPLEMENTARY INFORMATION section below for instructions on
submitting comments.
    You may inspect the material proposed for incorporation by
reference at Room 1601, Environmental Standards Division, U.S. Coast
Guard Headquarters, 2100 Second Street, SW., Washington, DC 20593
between 9 a.m. and 5 p.m., Monday through Friday, except Federal
holidays. The telephone number is<PHONE_NUMBER>. 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 proposed
rulemaking, call or e-mail Mr. John Morris, Project Manager,
Environmental Standards Division, U.S. Coast Guard Headquarters,
telephone<PHONE_NUMBER>, e-mail<EMAIL_ADDRESS>If you have
questions on viewing or submitting material to the docket, call Ms.
Renee Wright, Chief, Dockets, Department of Transportation, telephone
202-366-9826.

SUPPLEMENTARY INFORMATION:

Table of Contents

I. Public Participation and Request for Comments
    A. Submitting Comments
    B. Viewing Comments and Documents
    C. Privacy Act
    D. Public Meeting
II. Table of Abbreviations
III. Legislative and Regulatory History
IV. Background and Purpose
V. Discussion of Proposed Rule
VI. Incorporation by Reference
VII. Regulatory Analysis
    A. Executive Order 12866
    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. Public Participation and Request for Comments

    We encourage you to participate in this rulemaking by submitting
comments and related materials. All comments received will be posted,
without change, to http://www.regulations.gov and will include any
personal information you have provided.

A. Submitting Comments

    If you submit a comment, please include the docket number for this
rulemaking (USCG-2001-10486), indicate the specific section of this
document to which each comment applies, and provide a reason for each
suggestion or recommendation. You may submit your comments and material
online or by fax, mail, or hand delivery, but please use only one of
these means. We recommend that you include your name and a mailing
address, an e-mail address, or a phone number in the body of your
document so that we can contact you if we have questions regarding your
submission.
    To submit your comment online, go to http://www.regulations.gov and
click on the ``submit a comment'' box, which will then become
highlighted in blue. Insert ``USCG-2001-10486'' in the Keyword box,
click ``Search'', and then click on the balloon shape in the Actions
column. If you submit your comments by mail or hand delivery, submit
them in an unbound format, no larger than 8[frac12] by 11 inches,
suitable for copying and electronic filing. If you submit comments by
mail and would like to know that they reached the Facility, please
enclose a stamped, self-addressed postcard or envelope.
    We will consider all comments and material received during the
comment period and may change this proposed rule based on your
comments.

B. Viewing Comments and Documents

    To view comments, as well as documents mentioned in this preamble
as being available in the docket, go to http://www.regulations.gov at
any time. Enter the docket number for this rulemaking (USCG-2001-10486)
in the Keyword box, and click ``Search''. You may also visit the Docket
Management Facility in Room W12-140 on the ground floor of the DOT West
Building, 1200 New Jersey Avenue, SE., Washington, DC 20590, between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays. We
have an agreement with the Department of Transportation to use the
Docket Management Facility.

C. Privacy Act

    Anyone can search the electronic form of all comments received into
any of our dockets by the name of the individual submitting the comment
(or signing the comment, if submitted on behalf of an association,
business, labor union, etc.). You may review a Privacy Act notice
regarding our public dockets in the January 17, 2008, issue of the
Federal Register (73 FR 3316).

D. Public Meeting

    We have determined that public meetings would aid this rulemaking.
Consequently, we plan to hold public

meetings at times and places to be announced by separate notices in the
Federal Register.

II. Table of Abbreviations

BWDS ballast water discharge standard(s)
BWE ballast water exchange
BWM ballast water management
BWMS ballast water management system(s)
cfu colony forming unit
CZMA Coastal Zone Management Act
DPEIS Draft Programmatic Environmental Impact Statement
EEZ U.S. Exclusive Economic Zone
EFH essential fish habitat
EPA Environmental Protection Agency
ESA Endangered Species Act
ETV Environmental Technology Verification
HAB Harmful algal blooms
IL Independent Laboratory
IMO International Maritime Organization
MARAD U.S. Maritime Administration
MEPC Marine Environment Protection Committee (of the IMO)
NANPCA Nonindigenous Aquatic Nuisance Prevention and Control Act of
1990
NARA National Archives and Records Administration
NBIC National Ballast Information Clearinghouse
NIS nonindigenous species
NISA National Invasive Species Act of 1996
NMFS National Marine Fisheries Service
OMSM Operation, Maintenance, and Safety Manual
ppt parts per thousand
SERC Smithsonian Environmental Research Center
STEP Shipboard Technology Evaluation Program

III. Legislative and Regulatory History

    Congress enacted the Nonindigenous Aquatic Nuisance Prevention and
Control Act of 1990 (NANPCA), 16 U.S.C. 4711 et seq., on November 29,
1990, and established the Coast Guard's regulatory jurisdiction over
ballast water management (BWM). To fulfill the directives of NANPCA,
the Coast Guard published a final rule in the Federal Register on April
8, 1993, titled ``Ballast Water Management for Vessels Entering the
Great Lakes''. 58 FR 18330. On December 30, 1994, we published another
final rule in the Federal Register titled ``Ballast Water Management
for Vessels Entering the Hudson River''. 59 FR 67632. These rules added
a new subpart C to 33 CFR part 151, ``Ballast Water Management for
Control of Nonindigenous Species in the Great Lakes and Hudson River'',
which established mandatory BWM procedures for vessels entering the
Great Lakes and Hudson River.
    Congress enacted the National Invasive Species Act (NISA) on
October 26, 1996, reauthorizing and amending NANPCA. 16 U.S.C. 4711 et
seq. Through NISA, Congress reemphasized the significant role the
discharge of ships' ballast water plays in the spread of nonindigenous
species (NIS), defined as any species or other viable biological
material that enters an ecosystem beyond its historic range, including
any such organism transferred from one country into another, in U.S.
waters and directed the Coast Guard to develop a voluntary national BWM
program. On May 17, 1999, the Coast Guard published an interim rule in
the Federal Register on this voluntary program titled ``Implementation
of the National Invasive Species Act of 1996 (NISA)''. 64 FR 26672. The
interim rule added a new Subpart D to 33 CFR part 151 titled ``Ballast
Water Management for Control of Nonindigenous Species in Waters of the
United States''. We published the final rule in the Federal Register on
November 21, 2001. 66 FR 58381.
    Through NISA, Congress also directed the Secretary of the
Department in which the Coast Guard is operating to submit a report to
Congress evaluating the effectiveness of the voluntary BWM program. In
the June 3, 2002, report to Congress, the Secretary of the Department
of Transportation \1\ concluded that low participation in the voluntary
program resulted in insufficient data for an accurate assessment of its
effectiveness. This finding triggered the requirement in NISA that the
voluntary BWM program become mandatory. A copy of the report to
Congress can be found in docket (USCG-2002-13147) at http://
www.regulations.gov.
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    \1\ The Coast Guard moved from the Department of Transportation
to the Department of Homeland Security on March 1, 2003. Homeland
Security Act of 2002, Pub. L. 107-296 (November 25, 2002), Title
VIII, Subtitle H, Section 888.
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    On July 28, 2004, we published a final rule in the Federal Register
titled, ``Mandatory Ballast Water Management Program for U.S. Waters''.
69 FR 44952. This final rule changed the national voluntary BWM program
to a mandatory one, requiring all vessels equipped with ballast water
tanks and bound for ports or places of the United States to conduct a
mid-ocean ballast water exchange (BWE), retain their ballast water
onboard, or use an alternative environmentally sound BWM method
approved by the Coast Guard.
    Also, on June 14, 2004, the Coast Guard published a final rule in
the Federal Register titled ``Penalties for Non-submission of Ballast
Water Management Reports''. 69 FR 32864. In this final rule, we
established penalties for failure to comply with the reporting
requirements located in 33 CFR part 151 and broadened the applicability
of the reporting and recordkeeping requirements to a majority of
vessels bound for ports or places of the United States.
    On August 31, 2005, we published a notice of policy in the Federal
Register titled ``Ballast Water Management for Vessels Entering the
Great Lakes that Declare No Ballast Onboard''. 70 FR 51831. Through
this policy, we established the best management practices for vessels
entering the Great Lakes that have residual ballast water and ballast
tank sediment.

IV. Background and Purpose

    Under the legislative mandate in NISA, the Coast Guard must approve
any alternative methods of ballast water management (BWM) that are used
in lieu of mid-ocean ballast water exchange (BWE) required under NISA.
16 U.S.C. 4711(c)(2)(D)(iii). NISA further stipulates that such
alternative methods must be at least as effective as BWE in preventing
or reducing the introduction of nonindigenous species into U.S. waters.
16 U.S.C. 4711(c)(2)(D)(iii). Finally, NISA requires the Coast Guard to
review and revise its BWM regulations not less than every three years
based on the best scientific information available to the Coast Guard
at the time of that review, and potentially to the exclusion of the BWM
methods listed at 16 U.S.C. 4711(c)(2)(D). 16 U.S.C. 4711(e).
    Determining whether an alternative method is as effective as BWE is
not an easy task. The effectiveness of BWE is highly variable, largely
depending on the specific vessel and voyage. These variables make
comparing the effectiveness of an alternative BWM method to BWE
extremely difficult. In addition, a majority of vessels are constrained
by design or route from practicing BWE effectively. This is supported
by BWE results which show a proportional reduction in abundance of
organisms, so every vessel then has a different allowable concentration
of organisms in its discharge. Thus, vessels with very large starting
concentrations of organisms in their ballast tanks might still have
large concentrations of organisms after BWE. Results from several
studies have shown the effectiveness of BWE varies considerably and are
dependent upon

vessel type (design), exchange method, ballasting system configuration,
exchange location, and method of study. One group of studies suggests
that the efficacy of ballast water exchange is 80-99 percent per event
(Dickman and Zhang 1999; Hines and Ruiz 2000; Rigby and Hallegraeff
1993; Smith et al. 1996; Taylor and Bruce 2000; Zhang and Dickman
1999). Other studies demonstrate that the volumetric efficiency of BWE
ranges from 50-90 percent (Battelle 2003; USCG 2001; Zhang and Dickman
1999).
    For these reasons, BWE is not well suited as the basis for a
protective programmatic regimen, even though it has been a useful
``interim'' management practice. We have concluded that, as an
alternative to using BWE as the benchmark, establishing a standard for
the concentration of living organisms that can be discharged in ballast
water would advance the protective intent of NISA and simplify the
process for Coast Guard approval of ballast water management systems
(BWMS). Additionally, setting a discharge standard would promote the
development of innovative BWM technologies, be used for enforcement of
the BWM regulations, and assist in evaluating the effectiveness of the
BWM program.
    Therefore, in this rulemaking, we would amend 33 CFR part 151 by
establishing two ballast water discharge standards (BWDS), which are
discussed below. We also propose amending 46 CFR part 162 by adding an
approval process for BWMS intended for use on board vessels to meet the
proposed discharge standard.
    Vessels that would be subject to today's proposed rulemaking would
also be subject to the December 2008 Environmental Protection Agency
(EPA) Vessel General Permit (VGP) issued under section 402 of the Clean
Water Act. That VGP contains discharge limits for a number of
discharges incidental to the normal operation of vessels, including
ballast water, and applies to vessels being used as a means of
transportation with incidental discharges into inland navigable waters
and the three mile U.S. territorial sea. For more information on the
VGP, visit EPA's Web site at: http://www.epa.gov/npdes/vessels. Nothing
in today's proposal is intended to affect in any way action EPA may
take in the future with respect to regulation of ballast water
discharges in the vessel general permit 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 Proposed Rule

A. Phase-One Ballast Water Discharge Standard (BWDS)

    This NPRM would require that all vessels that operate in U.S.
waters, are bound for ports or places in the U.S., and are equipped
with ballast tanks, install and operate a Coast Guard approved ballast
water management system (BWMS) before discharging ballast water into
U.S. waters. This would include vessels bound for offshore ports or
places. It would not include vessels that operate exclusively in one
Captain of the Port (COTP) Zone, as it is unlikely that vessels
operating only within one COTP Zone would introduce invasive species
(from outside of that COTP Zone) into the waters of their COTP Zone.
Whether the vessel traveled 200 nautical miles offshore would no longer
be a factor in determining applicability. This means that some vessels
that operated exclusively in the coastwise trade, which were previously
exempt from having to perform ballast water exchange (BWE), would now
be required to meet the BWDS. This requirement is intended to meet the
directives under NISA that requires the Coast Guard to ensure to the
maximum extent practicable that nonindigenous species (NIS) are not
introduced and spread into U.S. waters and that they apply to all
vessels equipped with ballast tanks that operate in U.S. waters. 16
U.S.C. 4711(c)(1), (c)(2)A, (e) and (f).
    The proposed rule includes a phase-in schedule for complying with
both the phase-one and phase-two proposed BWDS based on each vessel's
ballast capacity and build date. During the phase-in period for the
phase-one standard, ballast water exchange (BWE) would remain as a
ballast water management (BWM) option for vessels not yet required to
meet the BWDS. At the end of the phase-one phase-in schedule, the
option of using BWE would be eliminated. From that date forward, all
vessels would be required to manage their ballast water through a Coast
Guard approved BWMS and meet either the proposed phase-one or phase-two
discharge standard, as applicable, or retain their ballast water
onboard.
    The phase-one BWDS proposed in this notice is the same standard
adopted by the International Maritime Organization (IMO) in 2004,
``International Convention for the Control and Management of Ships'
Ballast Water and Sediments'' (BWM Convention). The USCG leads the U.S.
government delegation to the IMO, the organization responsible for
improving maritime safety and preventing pollution from vessels. In
September 1995, the IMO identified NIS as a major issue confronting the
international maritime community. To address the issue, in 1997, the
IMO adopted voluntary guidelines, ``International Guidelines for
Preventing the Introduction of Unwanted Aquatic Organisms and Pathogens
from Ships' Ballast Water and Sediment Discharges.'' In February 2004,
the IMO adopted the BWM Convention, which establishes BWM procedures
and includes an international standard for BWD. The USCG coordinated
U.S. participation in this effort with the Environmental Protection
Agency, the National Oceanic and Atmospheric Administration, the U.S.
Department of Defense, the U.S. Maritime Administration, the U.S.
Department of Justice, and the U.S. Department of State. The BWM
Convention opened for ratification in February 2004, and under its
terms does not enter into force until one year after ratification by 30
countries representing not less than 35 percent of the gross tonnage of
the world's merchant shipping. To date, the BWM Convention is not in
force.
    The Draft Programmatic Environmental Impact Statement (DPEIS)
(available in the docket for this rule where indicated under ADDRESSES)
states that the phase-one proposed BWDS should markedly decrease the
risks of vessel-mediated introductions of NIS into U.S. waters,
relative to the status quo. We also consider that this BWDS, which has
become the de facto international efficacy target for developers of
BWMS, will be practicable to implement in the near term. Currently,
numerous technology developers are submitting BWMS designed to meet
this standard to several foreign governments for testing in accordance
with the IMO guidelines for approval of BWMS. All indications are that
there will soon be technologies available on the market to allow
vessels to meet this standard. As of July 2009, there have been 15 BWMS
given IMO basic approval and of those 15, eight have been given IMO
final approval. Further, six BWMS have received type approval
certifications under the requirements of the convention from foreign
administrations (Liberia, Germany, Norway, and United Kingdom). Some of
the manufacturers of BWMS that have been given type approval have
received orders from vessel owners to purchase those BWMSs.

B. Phase-Two Ballast Water Discharge Standard (BWDS)

    While the proposed phase-one BWDS is practicable to achieve in the
near term and will considerably advance environmental protection over
the current exchange-based regime, we also recognize that it should not
be the ultimate endpoint for protection of U.S. waters. We note that a
number of states have already adopted BWDS using more stringent
standards. We have considered information concerning whether technology
to achieve this standard can practicably be implemented now or by the
compliance dates under consideration. Although some technologies may be
capable of achieving the phase-two standard, we believe there is not
now a testing protocol capable of establishing that a technology
achieves the phase-two standard and testing results under existing
protocols do not provide sufficient statistical confidence to establish
that technologies consistently meet the phase-two standard.
    The purpose of NISA, as already noted, is to ensure to the maximum
extent practicable that NIS are not introduced and spread into U.S.
waters. Our phase-two standard represents a standard that is
potentially 1,000 times more stringent than the phase-one standard. We
believe that setting this more stringent standard and establishing
implementation dates for the phase-two BWDS will encourage technology
vendors to develop technologies capable of meeting the phase-two
standard. In addition, we expect to continue cooperative work to
establish testing protocols that can establish that technologies meet
the standard with adequate statistical confidence.
    We propose incorporating a practicability review into the phase-in
schedule for the phase-two BWDS. The purpose of the review is to
determine whether technology to achieve the performance standard can
practicably be implemented, in whole or in part, by the applicable
compliance dates. This includes more than just looking at whether there
is technology available to achieve the phase-two standard, as we
discuss later in this preamble. The initial review would be completed
in early 2013 and, in the event that some or all of the phase-two
standard is found to be not practicable, the compliance date for those
elements found not to be practicable would be extended in accordance
with the findings of the practicability review. At the same time, a
date for the next practicability review would be established, no later
than two years after the completion of the first practicability review
(i.e., no later than 2015). In establishing this time frame we are
attempting to balance our intent to implement the phase-two standards
as expeditiously as practicable with a consideration of how quickly
progress in developing and testing technology may be likely to occur.
We seek comment on whether one year or three years would be a more
appropriate time limit for further practicability review, should one or
more be needed.
    The Coast Guard will seek public input in preparing the
practicability review, and any decision to extend the compliance date
of elements of the phase-two standards found not to be practicable
would be subject to the requirements of the Administrative Procedure
Act.
    We've also left open the possibility that the practicability review
might reveal that a more stringent standard between the proposed phase-
one and the phase-two BWDS is achievable. We also allow for the
possibility that technology might be capable of achieving a standard
that is even more stringent than what we have proposed as the phase-two
BWDS. In these cases, we would propose amending either the
implementation timeline or the phase-two standard, or both, at the time
that we publicize the results of our practicability review. Once the
phase two standards are fully implemented, the Coast Guard would
continue to review the standards every three years, as required by
NISA, to ensure that they continue to ensure, to the maximum extent
practicable, that aquatic nuisance species are not introduced and
spread into U.S. waters.
    In addition to the comments we receive from the public, we also
will use the technical information gained from the rigorous testing of
BWMS here and in other countries to determine whether it is practicable
to meet the phase-two BWDS on the timeline we have proposed in this
NPRM. The testing conducted for purposes of type approval in the U.S.
and abroad, as well as testing for other purposes (such as the Coast
Guard's Shipboard Technology Evaluation Program and the U.S.
Environmental Protection Agency's (EPA) Environmental Technology
Verification Program, discussed later in this preamble), will provide
credible and standardized data on the performance characteristics of
BWMS. We will use technical information from these testing activities
and any other information to complete the practicability review
proposed in this NPRM. This practicability review could entail more
than determining whether there exists one system that is capable of
meeting the phase-two standard. It could also include additional
parameters, such as the capability of the vendor(s) to make the
system(s) available, and the ship building and repair industry to
install, systems in a timely and practicable manner given the large
number of vessels that would require such system(s), and the cost
impact of the system(s) on the regulated industry. We request comment
on the appropriate scope of the practicability review and, in
particular, how and to what extent costs should be considered in the
review.
    Practicability could also include consideration of scientific
factors beyond technology. For example, it could include the likely
effect of a particular decrease in the threshold concentration on the
probability of introduced organisms successfully establishing
populations in U.S. waters. Currently, the scientific understanding of
the quantitative relationships between the frequency and magnitude of
introductions and the probability of successful establishment is not
well understood for aquatic species. Given that such information will
help to improve our ability to evaluate appropriate prevention
measures, we will work to elevate the priority of this topic for
research by the Coast Guard, resource agencies and others funding
environmental science. We request comment on whether and how such
factors should be considered in the practicability review.

C. Applicability

    The Coast Guard proposes that the ballast water discharge standard
apply to all vessels discharging ballast water into U.S. waters. In
accordance with NISA, certain vessels would be exempt from the
requirements to install and operate a Coast Guard approved BWMS,
including:
     Crude oil tankers engaged in coastwise trade (16 U.S.C.
4711(c)(2)(L));
     Any vessel of the U.S. Armed Forces as defined in the
Federal Water Pollution Control Act (33 U.S.C. 1322(a)) that is subject
to the Uniformed National Discharge Standards for Vessels of the Armed
Forces (33 U.S.C. 1322(n)) (16 U.S.C. 4711(c)(2)(J)); and
     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 (consistent with IMO BWM Convention,
Article 3; 1982 United Nations Convention on the Law of the Sea,
Article 236).

    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 program,
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 Coast Guard initiated a BWMS research program on January 7,
2004, called the Shipboard Technology Evaluation Program (STEP). 69 FR
1082. STEP is intended to facilitate research, development, and
shipboard testing of effective BWMS. Vessels participating in STEP
would be granted equivalencies to the BWMS approval requirements of the
proposed rule. In the event that information learned during STEP on any
experimental BWMS leads the Coast Guard to conclude that there is a
risk to the environment, vessel, and/or human health, testing of the
BWMS would be stopped and acceptance to STEP would be withdrawn. This
would mean that the equivalency determination would also be withdrawn,
and that the vessel would be required to use a different Coast Guard
approved BWMS to meet the requirements of the proposed rulemaking. More
information on STEP can be found at: http://www.uscg.mil/
environmental_standards/.
    The Coast Guard would consider, on a case-by-case basis, making
equivalency determinations for vessels participating in similar
research programs conducted by Foreign Administrations or State
governments. In such cases, the vessel owner or operator would request
an equivalency determination from the Coast Guard. If a vessel granted
an equivalency determination is later removed from one of these
programs, the vessel would be required to install a different Coast
Guard approved BWMS to meet the requirements of the proposed rule.

D. Proposed Discharge Standards

    The current BWM regulations in 33 CFR part 151 are split into two
regulatory regimens--the Great Lakes Ballast Water Management Program
and the U.S. Ballast Water Management Program. These regulations are
found in 33 CFR part 151 subparts C and D, respectively. In this
proposed rule, we would establish a phase-one and phase-two discharge
standard for all vessels that discharge ballast water into U.S. waters.
However, we would keep subparts C and D separate to retain some pre-
existing regulations that are specific to the Great Lakes. We are
retaining these pre-existing regulations, specific to the Great Lakes,
because we want to be consistent with the Department of
Transportation's Saint Lawrence Seaway Development Corporation's BWM
regulations and Canadian (Transport Canada) BWM regulations. Also, the
uniqueness of vessel traffic patterns into the Great Lakes warrants
special treatment, as reflected in the pre-existing regulations.
    Invasive species have proven to be a significant and costly problem
in the Great Lakes. NISA explicitly recognized that some areas might
require special protections by providing that ballast water management
regulations may be regional in scope. The Coast Guard thus requests
comment on the appropriateness of the proposed rule for control of
invasive species from ballast waters discharged into the Great Lakes or
other areas. More specifically, are there characteristics of the Great
Lakes ecosystem or other ecosystems that would justify more stringent
standards or earlier compliance dates for ships operating in the Lakes
or other areas than for ships in other U.S. waters, keeping in mind
that NISA also requires that such regulations should be practicable?
Should the regulations include provisions that apply only to the Great
Lakes or other areas? What provisions of the proposed rule might be
changed in light of the identified special circumstances in the Great
Lakes or other locations (e.g.: Compliance schedules, treatment
levels)? In addition, are there practices or technologies not addressed
in the proposed rule that might be practicably applied specifically to
protection of the Great Lakes or other ecosystems (e.g.: On-shore
treatment or prior to entering freshwater or limitations on access to
the Lakes or other areas for vessels that pose a special risk of
discharge of new invasive species, and if so, how would those special
risks be assessed in a practicable manner)? Please provide explicit
information on the practicability of any such proposed approaches,
including costs and resources required to implement and maintain such
requirements.
    The proposed phase-one standard for allowable concentrations of
living organisms in ships' ballast water is:
    (1) For organisms larger than 50 microns in minimum dimension:
Discharge less than 10 organisms per cubic meter of ballast water.
    (2) For organisms equal to or smaller than 50 microns and larger
than 10 microns: Discharge less than 10 organisms per milliliter (ml)
of ballast water.
    (3) Indicator microorganisms must not exceed:
    (a) For toxicogenic Vibrio cholerae (serotypes O1 and O139): A
concentration of <1 colony forming unit (cfu) per 100 ml;
    (b) For Escherichia coli: A concentration of <250 cfu per 100 ml;
and
    (c) For intestinal enterococci: a concentration of <100 cfu per 100
ml.
    The Coast Guard has determined that the proposed phase-one standard
for ballast water discharge would provide a greater degree of
protection than BWE and will help reduce the risk of NIS introductions.
In our study of five alternative ballast water discharge standards,
detailed in the Draft Programmatic Environmental Impact Statement
(DPEIS), we estimated that ballast water treatment to achieve the
phase-one standard proposed in this rulemaking would be up to 60% more
effective than BWE and 80% more effective than unmanaged ballast water
discharge in preventing the probability of biological invasions.
    As described and discussed in Section 4 (Environmental
Consequences) of the DPEIS, the alternative ballast water discharge
standards compared in the NEPA assessment can be expressed in terms of
the proportion of organisms in different size classes that will be
prevented from being introduced. Table 1 describes the alternative
BWDS.

                                 Table 1--Allowable Concentration of Organisms in BWD, by Size, for Alternatives 2-4 \2\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Bacteria
                                                          Small organisms >10 --------------------------------------------------------------------------
                                    Large organisms >50   and <=50 microns in    Toxigenic Vibrio
                                      microns in size            size            cholerae (O1 and           E. coli            Intestinal enterococci
                                                                                O139)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Alternative 2....................  <10 per m\3\........  <10 per ml..........  <1 cfu per 100 ml...  <250 cfu per 100 ml.  <100 cfu per 100 ml.

Alternative 3....................  <1 per m\3\.........  <1 per ml...........  <1 cfu per 100 ml...  <126 cfu per 100 ml.  <33 cfu per 100 ml.
Alternative 4....................  <0.1 per m\3\.......  <0.1 per ml.........  <1 cfu per 100 ml...  <126 cfu per 100 ml.  <33 cfu per 100 ml.
--------------------------------------------------------------------------------------------------------------------------------------------------------

    In addition to the alternatives shown in the table above,
Alternative 5 (which is essentially sterilization) would require the
removal or inactivation of all living membrane-bound organisms
(including bacteria and some viruses) larger than 0.1 micron. The
mathematical modeling approach that we used in the DPEIS provides an
assessment of the relative effectiveness in increasing extinction
probability, by taxonomic group, of a particular alternative ballast
water discharge standard. Relative effectiveness is measured by the
proportional increase in theoretical extinction probability over the
`no management' option (No Action Alternative).
---------------------------------------------------------------------------

    \2\ Note, for ease of comparison within the Table, the
alternatives have all been standardized to numbers of organisms per
standard unit of volume. For organisms larger than 50 microns, the
unit volume is one cubic meter. For organisms less than or equal to
50 microns, but greater than 10 microns, the unit volume is 1
milliliter. Note also that if expressed in terms of whole numbers of
organisms in a volume, alternative 4 would be equal to less than 1
organism per 10 cubic meters or 10 milliliters of water (depending
on size class) and the phase two standard would be less than 1
organism per 100 cubic meters or 100 milliliters of water (depending
on size class).
---------------------------------------------------------------------------

    This mathematical or analytical approach can be used to compare the
alternatives in relative terms, but not in absolute terms. For example,
Alternative 5 in the DPEIS results in no introduction of nonindigenous
species via ballast water, whereas Alternatives 2, 3, and 4 increase
extinction probability, and thus decrease the probability of successful
invasions by different factors when compared to the No Action
Alternative. The comparison is relative, rather than absolute, because
the analysis was done using a specific and highly limited, but
reasonable, set of estimates for the controlling variables. These
variables include initial population size, threshold population size
for extinction, population growth rate, and population variability
around the mean growth rate. It is important to understand that these
predictions relate to relative, not absolute, differences in risk
reduction. Table 2 illustrates the potential impacts to the various
environments in relation to vessels treating their ballast water to the
alternative BWDS.

                                                           Table 2--Comparison of Alternatives
--------------------------------------------------------------------------------------------------------------------------------------------------------
             Resource                  Alternative 1         Alternative 2         Alternative 3        Alternative 4              Alternative 5
--------------------------------------------------------------------------------------------------------------------------------------------------------
Marine Ecosystems................  Current impacts       Minor to moderate     Moderate reduction    Moderate to major    Unquantified. Impacts would
                                    would continue--      reduction in NIS      in NIS                reduction in NIS     likely be greatly reduced
                                    trophic               introductions,        introductions,        introductions,       compared to the other
                                    interactions,\1\      resulting in fewer    resulting in fewer    resulting in fewer   alternatives.
                                    changing community    negative changes to   negative changes to   negative changes
                                    structures,\2\        natural community     natural community     to natural
                                    harmful algal         structures, fewer     structures, fewer     community
                                    blooms (HAB),         HAB.                  HAB.                  structures, fewer
                                    effects on                                                        HAB.
                                    ecosystem
                                    services.\3\
Estuarine Ecosystems.............  Current impacts       Minor to moderate     Moderate reduction    Moderate to major    Unquantified. Impacts would
                                    would continue --     reduction in NIS      in NIS                reduction in NIS     likely be greatly reduced
                                    erosion, turbidity,   introductions,        introductions,        introductions,       compared to the other
                                    trophic               resulting in less     resulting in less     resulting in less    alternatives.
                                    interactions,         erosion, fewer        erosion, fewer        erosion, fewer
                                    changing community    negative changes to   negative changes to   negative changes
                                    structures, HAB,      natural community     natural community     to natural
                                    effects on            structure, fewer      structure, fewer      community
                                    ecosystem services.   HAB, lessened         HAB, lessened         structure, fewer
                                                          negative impacts on   negative impacts on   HAB, lessened
                                                          ecosystem services.   ecosystem services.   negative impacts
                                                                                on ecosystem
                                                                                services.
Freshwater Ecosystems............  Current impacts       Minor to moderate     Moderate reduction    Moderate to major    Unquantified. Impacts would
                                    would continue--      reduction in NIS      in NIS                reduction in NIS     likely be greatly reduced
                                    erosion, trophic      introductions,        introductions,        introductions,       compared to the other
                                    interactions,         resulting in less     resulting in less     resulting in less    alternatives.
                                    changing community    erosion, fewer        erosion, fewer        erosion, fewer
                                    structures, effects   negative changes to   negative changes to   negative changes
                                    on ecosystem          natural community     natural community     to natural
                                    services.             structure, fewer      structure, fewer      community
                                                          HAB, lessened         HAB, lessened         structure, fewer
                                                          negative impacts on   negative impacts on   HAB, lessened
                                                          ecosystem services.   ecosystem services.   negative impacts
                                                                                on ecosystem
                                                                                services.

Threatened and Endangered Species  Current impacts       Minor to moderate     Moderate reduction    Moderate to major    Unquantified. Impacts would
                                    would continue,       reduction in NIS      in NIS                reduction in NIS     likely be greatly reduced
                                    trophic               introductions,        introductions,        introductions,       compared to the other
                                    interactions,         resulting in fewer    resulting in fewer    resulting in fewer   alternatives.
                                    changing community    negative changes to   negative changes to   negative changes
                                    structures, HAB,      natural community     natural community     to natural
                                    disruption of food    structure, fewer      structure, fewer      community
                                    sources, effects on   HAB, less             HAB, less             structure, fewer
                                    ecosystem services.   disruption of food    disruption of food    HAB, less
                                                          sources, lessened     sources, lessened     disruption of food
                                                          negative impacts on   negative impacts on   sources, lessened
                                                          ecosystem services.   ecosystem services.   negative impacts
                                                                                on ecosystem
                                                                                services.
Essential Fish Habitat...........  Current impacts       Minor to moderate     Moderate reduction    Moderate to major    Unquantified. Impacts would
                                    would continue,       reduction in NIS      in NIS                reduction in NIS     likely be greatly reduced
                                    trophic               introductions,        introductions,        introductions,       compared to the other
                                    interactions,         resulting in fewer    resulting in fewer    resulting in fewer   alternatives.
                                    changing community    negative changes to   negative changes to   negative changes
                                    structures, HAB,      natural community     natural community     to natural
                                    degradation of        structure, fewer      structure, fewer      community
                                    habitat.              HAB, less             HAB, less             structure, fewer
                                                          degradation of        degradation of        HAB, less
                                                          habitat.              habitat.              degradation of
                                                                                habitat.
Socioeconomics...................  Disruptions of        Minor to moderate     Moderate reduction    Moderate to major    Unquantified. Impacts would
                                    fisheries, fouling    reduction in NIS      in NIS                reduction in NIS     likely be greatly reduced
                                    of environment,       introductions,        introductions,        introductions,       compared to the other
                                    reduction in          resulting in less     resulting in less     resulting in less    alternatives.
                                    tourism due to        fouling of the        fouling of the        fouling of the
                                    fouling, higher       environment, fewer    environment, fewer    environment, fewer
                                    costs from NIS        fishery               fishery               fishery
                                    impacts & responses   disruptions, and      disruptions, and      disruptions, and
                                    to them.              less revenue lost     less revenue lost     less revenue lost
                                                          from a decrease in    from a decrease in    from a decrease in
                                                          tourism due to NIS    tourism due to NIS    tourism due to NIS
                                                          impacts on the        impacts on the        impacts on the
                                                          environment.          environment.          environment.
--------------------------------------------------------------------------------------------------------------------------------------------------------
Resources listed are from Chapter 3, Affected Environment. Reduction amounts, and therefore environmental impacts, are based on the modeling results
  described in Chapter 4, Environmental Consequences. Further descriptions of the environmental impacts are found in Chapter 4, Environmental
  Consequences. Alternatives 2-5 are compared to the No Action Alternative (both BWE and no BWM) as a baseline.
Notes: 1. Trophic interactions pertain to the feeding relationships between organisms in a food web.
2. Community structure refers to the physical structure and composition, as well as energy flows, of a community of organisms.
3. Ecosystem services are those resources and processes that are performed by natural systems for which there is human demand and benefit.

                        Table 3--Comparison of the Relative Effectiveness of Alternatives
----------------------------------------------------------------------------------------------------------------
                                                                          Ne = 1                 Ne = 100
                                                                 -----------------------------------------------
                           Alternative                              No BWM        BWE       No BWM        BWE
                                                                   (percent)   (percent)   (percent)   (percent)
----------------------------------------------------------------------------------------------------------------
2...............................................................          52          37          78          63
3...............................................................          73          64          94          90
4...............................................................          88          85         100         100
----------------------------------------------------------------------------------------------------------------
Ne is the extinction threshold of the population in the model.

    Alternative 3 could be 64% more effective than BWE and 94% more
effective than unmanaged ballast water discharge and Alternative 4
could be 85% more effective than BWE and 100% more effective than
unmanaged ballast water discharge in preventing the probability of
biological invasions as shown in Table 3.
    As noted above, this proposed rule would remove the option of
conducting BWE as a ballast water management method per the compliance
dates of the implementation schedule, which detail the timeframe that
vessels would be required to install and operate a Coast Guard approved
BWMS.
    The proposed phase-two standard for allowable concentrations of
living organisms in ships' ballast water is:
    (1) For organisms larger than 50 microns in minimum dimension:
Discharge less than 1 per 100 cubic meter of ballast water;
    (2) For organisms equal to or smaller than 50 microns and larger
than 10 microns: Discharge less than 1 organism per 100 milliliter (ml)
of ballast water;
    (3) For organisms less than 10 microns in minimum dimension:
    (i) Discharge less than 10\3\ living bacterial cells per 100 ml of
ballast water; and
    (ii) Discharge less than 10\4\ viruses or viral-like particles per
100 ml of ballast water; and
    (4) Indicator microorganisms must not exceed:
    (i) For Toxicogenic Vibrio cholerae (serotypes O1 and O139): A
concentration of <1 colony forming unit (cfu) per 100 ml;
    (ii) For Escherichia coli: A concentration of <126 cfu per 100 ml;
and

    (iii) For intestinal enterococci: A concentration of <33 cfu per
100 ml.
    This phase-two standard largely mirrors the standard proposed by
the U.S. during negotiations for the IMO BWM convention and the more
stringent standard established by several states, either under the
states' authority or as state conditions to the Environmental
Protection Agency (EPA) Vessel General Permit (VGP).
3. Proposed Implementation Schedule
    The proposed implementation schedule for meeting the proposed
phase-one ballast water discharge standard is shown in Table 4. The
proposed implementation schedule for meeting the proposed phase-two
ballast water discharge standard is shown in Table 5. Our proposed
implementation schedule would provide vessel owners and operators
sufficient time to install the necessary equipment needed to comply
with the phase-one discharge standard, without causing significant
disruptions to vessels operations and maritime commerce. Our phase-one
implementation schedule is similar to the implementation schedule for
the IMO Convention as they are both based on build date and ballast
water capacity. An implementation schedule using build dates and
ballast water capacities was determined by the Coast Guard and IMO to
be an appropriate mechanism for giving both vessel owners and BWMS
manufacturers enough time to have BWMS approved and installed while
avoiding long delays at shipyards where these installations would take
place. As there are limited numbers of shipyards around the world,
vessel owners must schedule BWMS installations well in advance. An
implementation schedule calling for faster installation would likely
make it difficult for vessel owners to comply with the requirements in
time. However, we are requesting comment specifically on whether it
would be possible for vessel owners to comply with a phase-one BWDS
implementation schedule that called for all existing vessels to install
an approved BWMS on their vessel by 2014.
    We also request comment on whether there are any facilities ready
to meet the requirements of becoming an Independent Lab (IL), and any
technology vendors ready to submit their system(s) to the proposed
protocols as soon as a facility is recognized as an IL, such that the
initial practicability review, now scheduled for January 2013, could be
moved to January 2012. If the IL and vendors were ready, would moving
the practicability review allow time for vessels with a 2014 compliance
date to implement technology meeting phase two standards in place of
technology meeting only phase one standards?

   Table 4--Proposed Implementation Schedule for the Phase-One Ballast
                        Water Management Program
------------------------------------------------------------------------
   Vessel's ballast water
  capacity  (cubic meters,          Vessel's         Vessel's compliance
            m\3\)               construction date           date
------------------------------------------------------------------------
New vessels: All............  On or after January   On Delivery.
                               1, 2012.
Existing vessels:
    Less than 1500..........  Before January 1,     First drydocking
                               2012.                 after January 1,
                                                     2016.
    1500-5000...............  Before January 1,     First drydocking
                               2012.                 after January 1,
                                                     2014.
    Greater than 5000.......  Before January 1,     First drydocking
                               2012.                 after January 1,
                                                     2016.
------------------------------------------------------------------------

   Table 5--Proposed Implementation Schedule for the Phase-Two Ballast
                        Water Management Program
------------------------------------------------------------------------
   Vessel's ballast water
  capacity  (cubic meters,          Vessel's         Vessel's compliance
            m\3\)               construction date           date
------------------------------------------------------------------------
New vessels: All............  On or after January   On Delivery.
                               1, 2016.
Existing vessels: All.......  Before January 1,     First drydocking
                               2016.                 after January 1,
                                                     2016, UNLESS the
                                                     vessel installed a
                                                     BWMS meeting the
                                                     phase-one standard
                                                     before January 1,
                                                     2016, then 5 years
                                                     after installation
                                                     of the BWMS meeting
                                                     the phase-one
                                                     standard.
------------------------------------------------------------------------

    Note that the phase-two standard implementation date for all
existing vessels that have not installed a BWMS meeting the phase-one
standard by January 1, 2016 is the same compliance date regardless of
the vessel's ballast water capacity. The only exception for this would
be for those vessels that have already installed a BWMS type approved
as meeting the phase-one standard. (These vessels would be allowed
additional time to comply with the phase-two standards, as discussed
below.) This is because we would be publishing the results of a
practicability review in early 2013 to determine whether it will be
practicable to meet the phase-two standard in the proposed timeline.
If, at that time, we determine that it is practicable, these vessels
would have enough time to plan for installation of a system capable of
meeting the phase-two standard and should be required to do so. If,
however, our practicability review indicates that it will not be
possible to implement the phase-two standard on our proposed timeline,
those vessels would still be required to install a system capable of
meeting the phase-one standard in accordance with the schedule in Table
4.
    The phase-two standard also includes a grandfather clause for those
vessels that install technology that has been type approved as meeting
the phase-one BWDS prior to January 1, 2016. We seek comment on whether
such a grandfather clause is necessary, and if so, whether the proposed
five-year period is enough time, more than enough time, or not long
enough. We specifically request information pertaining to the impacts,
cost and otherwise, of the grandfather clause as it is proposed, as
well as not having a grandfather clause (i.e., requiring all vessels to
install a phase-two technology at their first dry dock after January 1,
2016). Assuming a grandfather period is necessary, what is the
appropriate period, and why?
4. Practicability Review
    We are proposing to require a practicability review, to be
published three years prior to the first implementation date for the
phase-two BWDS, in order to determine whether the technology to achieve
and verify compliance with the phase-two

performance standard can practicably be implemented, in whole or in
part, by the applicable compliance date.
    This review would seek to determine first whether there was any
technology with the verified ability to achieve the phase-two standard.
It would examine whether that technology could be practicably made
available in time to meet the implementation schedule. This review
would then be used to determine whether to allow the phase-two
implementation schedule to come into effect, to delay the schedule by
some period of time, or to amend the standard and/or schedule to
reflect the practicability review conclusions on what performance
standards existing or emerging technologies could meet. Any proposed
amendments to the standard or the schedule would be done through rule
making and could also include consideration of grandfather periods for
owners of vessels that have already complied with an earlier standard.
    The practicability review would also consider, among other factors,
whether testing protocols are available to verify that treatment
technologies can be expected to comply with the phase-two performance
standard. Development of protocols capable of determining compliance
with the phase-two is a high priority for the Coast Guard. Other
factors to be considered could include cost of compliant treatment
technologies, and whether any amendments have been made to the IMO
Ballast Water Management Convention.
    We've also left open the possibility that the practicability review
might reveal that a more stringent standard between the proposed phase-
one and the phase-two BWDS is achievable. We also allow for the
possibility that technology might be capable of achieving a standard
that is more stringent than what we have proposed as the phase-two
BWDS. In the event the IMO BWM Convention standard is subsequently
raised, we would expect at least a matching increase in the domestic
standard. In these cases, we would propose to revise this regulation to
amend either the implementation timeline or the phase-two standard, or
both, at the time that we publicize the results of our practicability
review.
5. Other Proposed Amendments to 33 CFR Part 151
    In subpart C, we would add relevant definitions. In subpart D, we
would add definitions, revise the provision allowing for discharge of
ballast water in extraordinary circumstance (previously known as the
``safety'' exemption), and add a requirement for the vessel owner or
operator to maintain the BWMS certificate of approval onboard the
vessel. Additionally, we would reorganize subpart D and revise all
section headings to remove the current question-and-answer format.

B. Approval Program

    The Coast Guard proposes to add requirements for the approval of
BWMS. These requirements would be added to 46 CFR Subchapter Q, by
creating a new subpart 162.060, ``Ballast Water Management Systems''.
In this new subpart, we would establish an approval program, including
requirements for designing, installing, operating, and testing BWMS to
ensure these systems meet required safety and performance standards.
These proposed approval requirements use information from the IMO G8
Guidelines for type approval of BWMS under the BWM Convention, the
Protocols for Verification of Ballast Water Treatment Systems developed
under EPA's Environmental Technology Verification (ETV) Program, and
existing Coast Guard approval requirements for equipment installed
onboard vessels.
1. Section-by-Section Summary of Changes to 46 CFR Subchapter Q Part
162
    In proposed Sec.  162.060-1, we describe the purpose and scope of
the approval requirements.
    In proposed Sec.  162.060-3, we define the terms used in the
subpart.
    In proposed Sec.  162.060-5, we list those standards which we
propose to incorporate by reference into the regulations.
    In proposed Sec.  162.060-10, we describe the content requirements
for a manufacturer submitting a Letter of Intent to the Coast Guard
stating that the manufacturer intends to begin testing of its BWMS in
order to obtain Coast Guard approval. We also describe the specific
procedures for obtaining approval of a BWMS.
    In proposed Sec.  162.060-12, we provide equivalent approval
procedures. First, a manufacturer whose BWMS has been approved by a
Foreign Administration may request a written determination from the
Coast Guard's Marine Safety Center that such approval by a Foreign
Administration is equivalent to a Coast Guard approval.
    Second, we recognize the importance of experimental shipboard
testing of prototype BWMS, and further recognize that shipboard testing
programs of prototype systems may be more intensive than the
requirements proposed in this subpart. We do not want to create
redundant requirements for BWMS already entered into recognized
national or international shipboard testing programs, as this would
constitute a disincentive for participation in these programs.
Therefore, this section allows for a manufacturer whose BWMS is
undergoing such shipboard testing under a recognized national program
to request an equivalency for the shipboard testing requirements. In
this case, the manufacturer would request an equivalency determination
from the Coast Guard's Marine Safety Center by submitting a description
of the BWMS, the specific information on the vessel where the shipboard
testing would occur, the testing protocols, and information about the
goals and expected results of the testing project, as well as a full
description of the recognized program under which the testing is taking
place. If a manufacturer is removed from one of these programs, the
manufacturer would need to make the appropriate arrangements in order
to comply with the requirements of proposed Sec.  162.060-28.
    Finally, if a manufacturer has already conducted a substantial
amount of land-based and/or shipboard testing independent of the
requirements of this subpart, the Coast Guard's Marine Safety Center
may make an equivalency determination. The manufacturer would submit a
written request for such a determination to the Coast Guard's Marine
Safety Center.
    In proposed Sec.  162.060-14, we describe the content requirements
of an application for Coast Guard approval of a BWMS. This section
states that each item requiring approval would be the subject of a
separate application.
    In proposed Sec.  162.060-16, we describe the procedures that would
be followed if the design or conditions of the original approval
changes, if a manufacturer wishes to change the design or conditions of
an approved system, or if the Coast Guard determines that an approval
or conditions of approval are no longer valid under the provisions of
proposed Sec.  162.060-14.
    In proposed Sec.  162.060-18, we state that the Coast Guard may
suspend, withdraw, or terminate approval of a BWMS if it is:
     Not in compliance with the requirements of approval;
     Unsuitable for its intended purpose;
     Not in compliance with the requirements of other
applicable laws, rules, and/or regulations;
     No longer being manufactured or supported; or
     Under an approval that expires.
    In proposed Sec.  162.060-20, we describe design and construction
requirements for BWMS. The IMO's

Marine Environment Protection Committee (MEPC) Technical Specifications
in section 4 of MEPC 125(53), ``Guidelines for Approval of Ballast
Water Management Systems'' provide a basis for the proposed
requirements. The proposed requirements also refer to the applicable
design and material requirements in the Coast Guard marine and
electrical engineering regulations found in 46 CFR subchapters F and J,
respectively.
    In proposed Sec.  162.060-22, we outline the marking requirements
for an approved BWMS.
    In proposed Sec.  162.060-24, we describe the requirements and
format of the test plans that would be required to be prepared prior to
conducting each test required by this subpart.
    In proposed Sec.  162.060-26, we describe the land-based testing
and evaluation requirements for BWMS approval. MEPC 125(53),
``Guidelines for Approval of Ballast Water Management Systems''
provides a basis for the proposed requirements. The proposed
requirements also incorporate findings from the draft Environmental
Technology Verification (ETV) protocols of the EPA's ETV Program. These
tests are designed to assess the ability of a BWMS to meet the BWDS
proposed in 33 CFR part 151 subparts C and D, evaluate the suitability
of the system for shipboard installation, and validate the operating
and maintenance parameters presented by the manufacturer.
    In proposed Sec.  162.060-28, we describe the shipboard testing
requirements that would have to be completed in addition to the land-
based testing requirements for Coast Guard approval of a BWMS.
    In proposed Sec.  162.060-30, we describe tests that would be
conducted on all electrical components submitted for approval as part
of the complete BWMS. These tests assess whether BWMS components would
operate properly for an extended period of time under harsh shipboard
operating and environmental conditions. The Independent Laboratory (IL)
would conduct all approval tests and evaluations under this subpart for
the applicant. The results of these tests must be included in the final
Test Report.
    In proposed Sec.  162.060-32, we describe the requirements for any
BWMS that utilizes or generates an active substance or preparation.
    In proposed Sec.  162.060-34, we describe the required contents of
the Test Report, format of the Test Report, and the IL's
responsibilities for completing the Test Report and submitting all
required information to the Coast Guard.
    In proposed Sec.  162.060-36, we describe the requirements of the
Quality Assurance Project Plans that the IL would develop and be
required to follow.
    In proposed Sec.  162.060-38, we describe the requirements for an
Operation, Maintenance, and Safety Manual (OMSM) that the manufacturer
would prepare and submit along with the application for approval
specified in this subpart. This OMSM would need to be kept onboard each
vessel with an approved BWMS.
    In proposed Sec.  162.060-40, we describe how ILs would obtain
recognition by the Coast Guard.
2. Discussion of Previous Comments on the Approval Program
    On August 5, 2004, the Coast Guard published a notice in the
Federal Register with a request for comments regarding, among other
things, whether proposing an approval program alongside a BWDS would be
necessary. 69 FR 47453. The Coast Guard further asked commenters to
identify, if they supported an approval program, what type of testing
procedures should be developed and what issues should be addressed;
such as water resources, water quality conditions, and any other
environmental conditions. We received 8 comments related to the
establishment of an approval program and discuss them below.
    Two commenters stated the Coast Guard should not require shipboard
testing. Both commenters stated that the Coast Guard has a long history
of providing onshore testing of equipment for Coast Guard approval, and
they saw no reason to depart from the practice. One commenter also
disagreed with shipboard testing due to logistical difficulty, time
delay, and expense.
    The Coast Guard disagrees. Land-based testing alone does not always
simulate long-term shipboard conditions. Moreover, the BWM Convention
G8 type-approval guidelines employ both land-based and ship-based
testing of BWMS. Therefore, the Coast Guard has proposed shipboard
testing requirements in this rulemaking.
    One commenter stated that on-shore testing will need to be
adaptable because various technologies may require their own
individualized regimen of tests.
    The Coast Guard agrees that test facilities must be adaptable for
different types of technologies, but we disagree that each technology
will require its own individualized regimen of tests during land-based
testing. To the greatest degree possible, test facilities must employ
standard test protocols to ensure that different technologies, tested
at different facilities and times, undergo the same level of testing.
Through the EPA's ETV program, stakeholder reviews, and partnerships
with the Naval Research Laboratory, we developed the standard protocols
for land-based tests found in this regulation. The basic parameters we
would incorporate for shipboard testing, however, allow the IL to
design tests that address specific needs of varying BWMS employing
different technologies.
    Two commenters recommended the Coast Guard use ILs to perform
approval tests. The Coast Guard agrees with these commenters and has
incorporated ILs into the proposed approval process.
    One commenter stated the Coast Guard should use its own expertise
with the additional resources available from classification societies
and EPA to make appropriate decisions, which consider the safety of the
vessel and crew as well as the harsh seafaring environment.
    The Coast Guard agrees and notes that we developed the BWDS and
approval requirements proposed in this notice utilizing existing Coast
Guard design and safety requirements, an extensive stakeholder review
process within the EPA's ETV program, and guidelines developed by the
IMO with input from classification societies.
    One commenter stated that whatever testing procedures are
ultimately adopted, it is essential that a sufficient number of
laboratories be established so that a given manufacturer's equipment
may be evaluated and approved no more than six to eight weeks after its
submission to the Coast Guard.
    The Coast Guard agrees that a sufficient number of laboratories
should be established; however, we disagree with the six to eight week
time period for approval after submission. Land based tests conducted
by the IL and the statutorily required environmental assessments
conducted by the Coast Guard during the approval process would
necessitate more than six to eight weeks for complete approval. It is
important to note that Coast Guard type approval of a BWMS does not
require each individual BWMS to be tested and evaluated. Under the
proposed process, a representative system would undergo the rigorous
tests for Coast Guard approval, and subsequent BWMS built to the same
design and within the rated capacity parameters would only require
installation surveys.

C. Enforcement and Compliance

    The Coast Guard would conduct enforcement and compliance activities
for the BWM program as part of the overall BWM enforcement and
compliance program. This program would continue to be conducted as part
of regularly scheduled Port State and Flag State exams and inspections,
as well as other continued compliance verification and outreach
efforts. All Coast Guard offices involved with BWM compliance would
maintain a local training and qualification program for its inspections
consistent with guidance provided by Office of Vessel Activities (CG-
543), Environmental Standards Division (CG-5224), Areas, Sectors, and
Districts.

VI. Incorporation by Reference

    Material proposed for incorporation by reference appears in 46 CFR
162.060-5. 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 Sec.  162.060-5.
    Before publishing a binding rule, we will submit this material to
the Director of the Federal Register for approval of the incorporation
by reference.

VII. Regulatory Analysis

    We developed this proposed rule after considering numerous statutes
and executive orders related to rulemaking. Below we summarize our
analysis based on 13 of these statutes or executive orders.

A. Executive Order 12866

    This proposed rule is a ``significant regulatory action'' under
section 3(f) of Executive Order 12866, Regulatory Planning and Review.
The Office of Management and Budget has reviewed it under that Order.
It requires an assessment of potential costs and benefits under section
6(a)(3) of that Order. A preliminary assessment (``Regulatory
Analysis'') is available in the docket where indicated under the
``Public Participation and Request for Comments'' section of this
preamble. A summary of the Regulatory Analysis (RA) follows:
    The RA provides an evaluation of the economic impacts associated
with the implementation of standards limiting the quantities of living
organisms in ships' ballast water discharged in U.S. waters. The focus
of this assessment is to analyze the costs and benefits of implementing
the phase one BWDS, which is the same standard adopted by the IMO in
2004.\3\
---------------------------------------------------------------------------

    \3\ International Convention for the Control and Management of
Ship's Ballast Water and Sediments (BWM Convention).
---------------------------------------------------------------------------

    While the proposed phase one BWDS is practicable to achieve in the
near term and will considerably advance environmental protection over
the current exchange-based regime, we also recognize that it is not the
ultimate endpoint for protection of U.S. waters. We note that a number
of states have already adopted BWDS using more stringent standards. The
purpose of NISA, as already noted, is to ensure, to the maximum extent
practicable, that NIS are not introduced and spread into U.S. waters.
Hence, the Coast Guard is proposing today the adoption of a more
stringent standard (phase-two standard) to take effect in 2016. The
phase-two standard represents a standard that is potentially 1,000
times more stringent than the phase-one standard. We wish to solicit
comments with respect to the following questions (when providing
comments, please explain the reasoning underlying your comment and
provide citations to and copies of any relevant studies, reports and
other sources of information on which you rely):
    1. What are the acquisition, installation, operation/maintenance
and replacement costs of technological systems that are able to meet
more stringent standards? Please provide quantitative cost data
specifying complete data sources, type of technology and testing
status, and the stringency (at 10x, 100x, and 1000x the IMO standard
and for sterilization).
    2. Are there technology systems that can be scalable or modified to
meet multiple stringency standards after being installed? Please
provide quantitative data specifying the technology, necessary
modifications (to go to a more stringent standard), costs, and sources
of the information.
    3. What are the additional costs for vessels compliant with the
phase-one standard to go to the phase- two standard? Please provide
quantitative cost data specifying complete data sources, type of
technology, and possible phase-two stringencies (at 10x, 100x, and
1000x the IMO standard and for sterilization).
    4. What are the technology alternatives and costs for smaller
coastwise vessel types? Please provide quantitative data specifying the
technology and stringency, costs, and sources of the information.
    5. What are the additional avoided environmental and social damages
and economic benefits of ballast water discharge standards at more
stringent standards? Please provide quantitative data and sources for
all information.
    6. In light of the potentially severe nature of such damages, does
the proposed rule ensure to the maximum extent practicable that aquatic
nuisance species are not discharged into waters of the United States
from vessels, as required by NISA? Would an approach that bypassed
phase-one and went directly to the phase-two standards be practicable
and provide greater protection of the aquatic environment? Please
provide quantitative data and sources to support your response.
    For more details on phase one and two BWDS, see the ``Discussion of
Proposed Rule'' section.
    For additional details on other alternatives considered for this
rulemaking, see the Draft Programmatic Environmental Impact Statement
(DPEIS) available on the docket.
    Population Affected:
    This proposed rule would affect vessels operating in U.S. waters
that are equipped with ballast tanks. These vessels would be required
to install and operate a Coast Guard approved ballast water management
system (BWMS) before discharging ballast water into U.S. waters. This
would include vessels bound for offshore ports or places. Additionally,
whether the vessel traveled 200 nautical miles offshore would not be a
factor in determining applicability. This means that some vessels that
operated exclusively in the coastwise trade, within the U.S. Exclusive
Economic Zone (EEZ), which were previously exempt from having to
perform ballast water exchange (BWE), would now be required to meet the
ballast water discharge standard (BWDS). See the ``Discussion of
Proposed Rule'' section of the NPRM for applicability of the rule
regarding vessel operation.
    The primary source of data used in this analysis is the Marine
Information for Safety and Law Enforcement (MISLE) system and Ballast
Water Reporting Forms for 2007 submitted to the National Ballast
Information Clearinghouse (NBIC), which maintains the reporting and
database. MISLE is the Coast Guard database system for information on
vessel characteristics, arrivals, casualties, and inspections. The NBIC
database provides information on the amount of ballast water discharged
in U.S. ports for the range of vessel types calling on U.S. waters.
Since October 2004, all vessels, U.S. and foreign, operating in U.S.
waters and bound for U.S. ports or places, have been required to submit
reports of their

BWM practices to the NBIC database. 33 CFR 151.2041.
    Approximately 7,575 vessels from the current vessel population, of
which 2,616 are U.S. vessels, would be required to meet the BWDS. We
propose that full implementation for the phase one BWDS would be
required by 2016. The installation requirements would be phased-in for
new and existing vessels over the 2012 through 2016 period.
    As previously mentioned, the BWDS analyzed in the RA is the same
standard as in the 2004 IMO BWM Convention (see the ``Discussion of
Proposed Rule'' section for more information on the ratification of the
Convention). For the purposes of the RA, we consider the costs of this
rulemaking to involve U.S. vessels.\4\ Nevertheless, we anticipate that
the development of treatment technology would involve the world fleet,
not the U.S. fleet alone. In order to estimate the cost associated with
BWMS on the U.S. fleet, we needed to develop the range of technologies
that may be available and the unit costs of these technologies. We
assume that there will be a broad market for the new BWMS that includes
both U.S. and foreign vessels, thus improving the range of technologies
available and the cost efficiencies of production.
---------------------------------------------------------------------------

    \4\ The RA presents cost estimates for foreign flag vessels
projected to call in U.S. waters.
---------------------------------------------------------------------------

    Costs:
    The IMO Convention has spurred development of BWMS designed to meet
the IMO discharge standard (phase-one BWDS). Various technologies are
being evaluated. Shipboard trials are being conducted for some of these
technologies, others are undergoing land-based laboratory testing,
while yet others have received type-approval from foreign
administrations.
    Not all systems are appropriate for all vessel types. Variation in
the operational costs relate, in part, to the use of chemicals or other
agents in the BWMS and are also due to the treatment of certain
discharges not required under current regulations. The BWMS on ships is
a new process for which there is minimal operating practical
experience, any discussion of the treatment technologies,
effectiveness, costs, and operating issues is provisional.
    Approximately 4,758 BWMS installations for the U.S. vessels would
be required by 2021 because of projected fleet growth. We expect
highest annual costs in the period between 2012 and 2016, as the bulk
of the existing fleet of vessels must meet the standards according to
the phase-in schedule proposed by this rulemaking (see Table 6). The
primary cost driver of this rulemaking is the installation costs for
all existing vessels. After installation, we estimate operating costs
to be substantially less.

                          Table 6--Costs to U.S. Vessels To Comply With Phase-One BWDS*
----------------------------------------------------------------------------------------------------------------
                                                                   Installation   Operating cost    Total cost
                              Year                                  cost ($Mil)       ($Mil)          ($Mil)
----------------------------------------------------------------------------------------------------------------
2012............................................................         $238.42           $0.18         $238.61
2013............................................................          223.91            0.34          224.25
2014............................................................          219.63            0.48          220.11
2015............................................................          171.40            0.59          171.99
2016............................................................          161.15            0.68          161.84
2017............................................................           33.82            0.66           34.47
2018............................................................           32.51            0.63           33.14
2019............................................................           31.24            0.61           31.85
2020............................................................           30.03            0.58           30.62
2021............................................................           28.87            0.56           29.44
                                                                 -----------------------------------------------
    Total.......................................................        1,171.00            5.32        1,176.31
    Annualized..................................................          166.72            0.76          167.48
----------------------------------------------------------------------------------------------------------------
* Present value costs discounted at 7 percent. See RA for additional discount factors. The period of analysis is
  10 years (2012-2021). Discounting begins in 2012.

    We estimate the first-year cost of this rulemaking to be $239
million based on a 7 percent discount rate. The total costs over the
phase-in period (2012-2016) range between $162 million to about $239
million depending on the year. Over the 10-year period of analysis
(2012-2021), the total cost of the phase-one BWDS for the U.S. vessels
is approximately $1.18 billion using the 7 percent discount rate. Our
cost assessment includes existing and new vessels.
    Because development and testing of technology to meet the phase-two
standards has not progressed as far as for technology to meet the
phase-one standards, we are not including cost data for the phase-two
standards at this time. In addition to requesting data from the public
through this notice (see above), the Coast Guard will seek data from
vendors and other sources on the costs of achieving the phase-two
standard prior to promulgation of the final rule.
    Economic Costs of Invasions of Nonindigenous Species (NIS):
    NIS introductions contribute to the loss of marine biodiversity and
have associated significant social, economic, and biological impacts.
NIS introductions in U.S. waters are occurring at increasingly rapid
rates. Avoided costs associated with future NIS invasions represent one
of the benefits of ballast water management (BWM). Economic costs from
invasions of NIS range in the billions of dollars annually. Evaluation
of these impacts was difficult because of limited knowledge of the
patterns and basic processes that influence marine biodiversity. The
most extensive review to date on the economic costs of introduced
species in the U.S. includes estimates for many types of NIS, and is
reflected in Table 7.

   Table 7--Estimated Annual Costs Associated to Aquatic Nonindigenous
                Species Introduction in the U.S. ($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 costs in
the billions of dollars per year.
    Benefits of Ballast Water Discharge Standards (BWDS):
    The benefits of BWDS are difficult to quantify because of the
complexity of the ecosystem and a lack of understanding about the
probabilities of invasions based on prescribed levels of organisms in
ballast water. However, evaluation of costs associated with previous
invasions (described above) allows a comparison of the cost of
discharge standards versus the costs avoided. Because the amount of
shipping traffic and the number of incidents of invasions per year are
both increasing, historical data provide a lower bound for the basis of
benefit evaluation.
    We assessed the functional benefits prior to comparing monetary
benefit measures. The primary functional benefits of this rulemaking
are:
     A reduction in the concentration of all organisms leading
to lower numbers of these organisms being introduced per discharge; and
     The elimination of the exemptions in the BWM regulations
leading to the discharge of unmanaged ballast water (e.g., safety
concerns during exchange, deviation/delay of voyage required to travel
to acceptable mid-ocean exchange location).
    This overall strategy should reduce the number of new invasions
because the likelihood of establishment decreases with reduced numbers
of organisms introduced per discharge or inoculation.
    We calculate potential benefits of the BWDS by estimating the
number of invasions reduced and the range of economic damage avoided.
We use information on the invasion rate of invertebrates from shipping
reported by Ruiz et al. (2000) to project the number of future shipping
invasions per year. We then estimate the number of fish and aquatic
plant invasions based on historical relationships of fish and plant
invasions to invertebrate invasions. We then adjust the projected
invasions to account for the fraction of invasions that are
attributable to ballast water and the fraction of invasions that cause
severe economic damage. The resulting projection of the number of
ballast water invasions that will cause harm is displayed in Table 8.

                      Table 8--Estimated Number of Ballast Water Invasions That Cause Harm
----------------------------------------------------------------------------------------------------------------
                              Year                                 Invertebrate        Fish        Aquatic plant
----------------------------------------------------------------------------------------------------------------
2012............................................................           0.372           0.074           0.149
2013............................................................           0.381           0.076           0.152
2014............................................................           0.390           0.078           0.156
2015............................................................           0.399           0.080           0.160
2016............................................................           0.409           0.082           0.164
2017............................................................           0.419           0.084           0.168
2018............................................................           0.429           0.086           0.172
2019............................................................           0.439           0.088           0.176
2020............................................................           0.450           0.090           0.180
2021............................................................           0.461           0.092           0.184
                                                                 -----------------------------------------------
Total...........................................................           4.149           0.830           1.659
----------------------------------------------------------------------------------------------------------------

    To estimate the potential economic harm that may be caused by these
invasions, we assign a cost per invasion based on the available data on
the range of costs and damages incurred by past invasions. As no
comprehensive estimate is available on the costs from past invasions,
we do not try to develop a composite cost estimate for all invasions,
but instead select a low and high estimate for fish, aquatic plants and
invertebrates based on representative species. We then calculate a mid-
point for the range and calculate costs for future invasions using all
three values. The resulting ranges of costs per invasions are
summarized in Table 9.

                    Table 9--Range of Annual Costs Associated With Selected NIS Introductions
                                                [$Million; $2007]
----------------------------------------------------------------------------------------------------------------
                                                                     Low range       Mid-range      High range
----------------------------------------------------------------------------------------------------------------
Fish............................................................           $15.8          $160.6          $305.3
Invertebrates...................................................            19.5           539.8           1,060
Aquatic Plants..................................................             4.5           214.6           424.7
----------------------------------------------------------------------------------------------------------------
Note: The RA contains additional details and source information.

    We assume that once an invasion is established, it will continue to
generate costs and/or damages for each year subsequent to the invasion.
Thus, an invasion that occurs in the first year of our analysis (2012)
will incur costs/damages in each of the next 10 years (through 2021).
Based on the cumulative impacts of invasions, we have calculated a mid-
range estimate of annual costs for all harmful ballast water-introduced
invasions over the 10 year period of 2012 to 2021 at $2.016 billion at
7 percent discount rate. These estimates assume no BWM.

    The Draft Programmatic Environmental Impact Statement (DPEIS) has
estimated the reduction in the mean rate of successful introductions of
various alternative standards. In comparison with the existing practice
of ballast water exchange, the proposed phase-one BWDS (Alternative 2
in the DPEIS) is between 37 percent and 63 percent more effective in
preventing invasions when fully implemented (see the DPEIS for further
details on effectiveness). We use these estimates of the reduction in
the rate of invasions to estimate the economic cost/damage avoided as a
result of a BWDS.
    As discussed earlier, the implementation of the phase-one BWDS
would be phased-in over several years. During the phase-in period of
2012-2016, there is considerable uncertainty as to how effective the
measures will be in preventing invasions if only a subset of ships have
implemented ballast water management. There is also uncertainty as to
the availability and effectiveness of ballast water management
technologies. Proper operation of these new technologies may require
training and experience on the part of vessel operators. For these
reasons we assume that no invasions will be avoided during the period
of 2012-2015, which may lead to an underestimate of potential benefits.
    The resulting damages avoided for the phase-one BWDS range from a
minimum of $6 million and the maximum is $553 million with a mid-range
estimate of $165-$282 million per year at a 7 percent discount rate
(Table 10).

                              Table 10--Benefits (Costs Avoided) for Phase-One BWDS
                                                   [$Millions]
----------------------------------------------------------------------------------------------------------------
                                            Low effectiveness--37%                High effectiveness--63%
               Year                -----------------------------------------------------------------------------
                                        Low          Mid          High         Low          Mid          High
----------------------------------------------------------------------------------------------------------------
2012..............................           $0           $0           $0           $0           $0           $0
2013..............................            0            0            0            0            0            0
2014..............................            0            0            0            0            0            0
2015..............................            0            0            0            0            0            0
2016..............................            2           66          130            4          113          222
2017..............................            5          125          246            8          214          419
2018..............................            7          178          349           11          303          595
2019..............................            8          225          441           14          382          750
2020..............................           10          266          521           17          452          887
2021..............................           11          301          592           19          513        1,008
                                   -----------------------------------------------------------------------------
    Total.........................           43        1,161        2,279           74        1,977        3,881
                                   -----------------------------------------------------------------------------
    Annualized....................            6          165          325           10          282          553
----------------------------------------------------------------------------------------------------------------
Note: Present value costs discounted at 7 percent.

    The annualized cost for domestic vessels over the 10-year period of
2012-2021 for the phase one BWDS is estimated at $167 million at a 7
percent discount rate. Thus, quantified benefits are roughly equal to
estimated costs for the mid-point cost estimate of the phase one BWDS
``Low Effectiveness''.

B. Small Entities

    Under the Regulatory Flexibility Act (5 U.S.C. 601-612), we have
considered whether this proposed 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.
    An Initial Regulatory Flexibility Analysis (IRFA) discussing the
impact of this proposed rule on small entities is available in the
docket where indicated under the ``Public Participation and Request for
Comments'' section of this preamble.
    Based on available data, we determined that about 57 percent of the
businesses affected are small by the Small Business Administration
(SBA) size standards. We discovered that these businesses operate
almost entirely in coastwise trade and are not involved with larger
scale trans-ocean shipping.
    Based on our assessment of the impacts from the phase-one BWDS, we
determined that some coastwise businesses would incur a significant
economic impact (more than 1 percent impact on revenue) during the
installation and phase-in period based. After installation, however,
most small businesses would not incur a significant impact from the
estimated annual recurring operating costs. We have determined that
this proposed rule would have a significant economic impact on a
substantial number of small entities under section 605(b) of the
Regulatory Flexibility Act.

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 consult Mr. John Morris, Project Manager, telephone
202-372-1433. The Coast Guard will not retaliate against small entities
that question or complain about this proposed 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 proposed rule would call for no new collection of information
under the Paperwork Reduction Act (PRA) of 1995 (44 U.S.C. 3501-3520).
    Our research indicates that there are 25-30 manufacturers
developing BWMS for installation onboard vessels.\5\ We expect to
receive less than 10 system approval requests per year. This figure is
less than the threshold of 10 per twelve-month period for collection of
information reporting purposes under the PRA of 1995.
---------------------------------------------------------------------------

    \5\ 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.
---------------------------------------------------------------------------

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 proposed rule under that Order and have
determined that it does not have implications for federalism. NANPCA,
as reauthorized and 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. It also requires that ``all 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 of
aquatic nuisance species into U.S. waters from ships' ballast tanks.
This makes it unlikely that preemption, which would necessitate
consultation with the States under Executive Order 13132, would occur.
If, at some later point in the rulemaking process, we determine that
preemption may become an issue, we would develop a plan for
consultation with affected States/localities.

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 or more in any
one year. This proposed rule would result in such an expenditure, and
we have included an ``Unfunded Reform Act Statement'' in the Regulatory
Assessment (Section 7), located in the docket where indicated under the
``Public Participation and Request for Comments'' section of this
preamble.

G. Taking of Private Property

    This proposed rule would not effect 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 proposed 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 proposed rule under Executive Order 13045,
Protection of Children from Environmental Health Risks and Safety
Risks. Though this proposed rule is economically significant, it would
not create an environmental risk to health or risk to safety that might
disproportionately affect children.

J. Indian Tribal Governments

    This proposed rule does not have tribal implications under
Executive Order 13175, Consultation and Coordination with Indian Tribal
Governments, because it would 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 proposed 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 (NTTAA) (15
U.S.C. 272) directs agencies to use voluntary consensus standards in
their regulatory activities unless the agency provides Congress,
through the Office of Management and Budget, 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 proposed rule would incorporate a number of technical
standards, all of which are voluntary consensus standards. These may be
found in the proposed approval program amendments to 46 CFR part 162.
Additionally, the proposed phase-one ballast water discharge standard
is also, at least for the time being, a voluntary consensus standard.
While the IMO BWM Convention has been adopted, it has not been ratified
by enough countries to bring it into force as an international
requirement. The phase-two standard is not a voluntary consensus
standard, but it is a standard that has been adopted by a number of
states.

M. Environment

    We have analyzed this proposed rule under Department of Homeland
Security Management Directive 023-01 and Commandant Instruction
M16475.lD, which guide the Coast Guard in complying with the National
Environmental Policy Act of 1969 (NEPA) (42 U.S.C. 4321-4370f), and
have made a determination that this action may have a significant
effect on the human environment. A Draft Programmatic Environmental
Impact Statement (DPEIS) is available in the docket where indicated
under the Public Participation and Request for Comments section of this
preamble. We encourage the public to submit comments on the DPEIS.
    On October 27, 2006, we initiated informal consultation with the
U.S. Fish and Wildlife Service and the National Marine Fisheries
Service (NMFS) regarding this proposed rule in accordance with Section
7 of the Endangered Species Act of 1973 (ESA) (Pub. L. 93-205, 81 Stat.
884, as amended; 16 U.S.C. 1531 et seq.) to

ensure that our actions are not likely to jeopardize the continued
existence of listed and proposed endangered and threatened species or
result in the destruction or adverse modification of critical habitat.
The consultation and determinations will be reflected in the Final
Programmatic Environmental Impact Statement (FPEIS).
    We initiated informal consultation with NMFS regarding this
proposed rule in accordance with the Magnuson-Stevens Act (Pub. L. 94-
265, as amended; 16 U.S.C. 1801 et seq.) to demonstrate that our
actions are not likely to affect essential fish habitat (EFH). The
DPEIS addresses the potential effects the proposed rule would have on
EFH and the FPEIS will contain a written assessment describing the
effects of our actions on EFH (50 CFR 600.920(e)(1)).
    We will seek Federal Consistency Determinations for 29 States and 5
U.S. Territories regarding this proposed rule as required by the
Coastal Zone Management Act (CZMA) of 1972 (16 U.S.C.A. Sec.  1451-
1465). Each Federal consistency determination letter will explain to
each State and U.S. Territories that the USCG's action is consistent,
to the maximum extent practicable, with the enforceable polices of each
State's and U.S. Territories approved CZM plan.
    As previously discussed in Section V.A.2. of this preamble, the
DPEIS includes a number of alternative discharge standards, with
Alternatives 3 and 4 establishing more stringent limits on
concentrations of living organisms in ships' ballast water than today's
proposed phase-one BWDS, and Alternative 5 requiring the removal or
inactivation of all living membrane-bound organisms (including bacteria
and some viruses) larger than 0.1 micron (this is essentially
sterilization). We recognize, however, that there is uncertainty
regarding the data used to complete the analysis for these more
stringent standards. We specifically request public comment on these
and other alternatives (e.g., standards proposed or adopted by various
states in their legislation or via the states' certification under
EPA's VGP, our proposed phase-two standard). While we welcome comment
on all aspects of alternative BWDS, we particularly wish to solicit
comment with respect to the following matters. When providing comments,
please explain the reasoning underlying your comment and provide
citations to and copies of any relevant studies, reports, or scientific
literature on which you rely.
    1. What BWDS is sufficient to adequately safeguard against the
introduction of species into U.S. waters via ships' ballast water?
Should the standard provide for zero risk of spreading invasive species
via ballast water (e.g. zero living organisms), or should the standard
be one that substantially mitigates any risk, but may not eliminate the
possibility of species being introduced?
    2. For any BWDS identified in response to (1), what is the evidence
that the systems can meet either of the BWDS proposed in this NPRM, and
what are the timeframes by which such BWDS can be achieved and what
technologies are, or will be, available to meet such BWDS?
    3. For any BWDS identified in response to (1), what are the costs
of such systems for various classes of ships and under differing
operating conditions? Additionally, what are power requirements on
board those vessels and what additional chemical storage requirements
and other space requirements are needed on board those vessels?
    4. Any studies that exist on the effects of propagule pressure on
successful establishment of a NIS in aquatic ecosystems.
    5. What are the advantages and disadvantages of a ballast water
discharge standard that is more stringent than the IMO standard? Please
provide quantitative data and sources of the information.

List of Subjects

33 CFR Part 151

    Administrative practice and procedure, Ballast water management,
Oil pollution, Penalties, Reporting and recordkeeping requirements,
Water pollution control, Ballast water management.

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 proposes
to amend 33 CFR part 151 and 46 CFR part 162 as follows:

Title 33--Navigation and Navigable Waters

CHAPTER I--COAST GUARD, DEPARTMENT OF HOMELAND SECURITY

Subchapter O--Pollution

PART 151--VESSELS CARRYING OIL, NOXIOUS LIQUID SUBSTANCES, GARBAGE,
MUNICIPAL OR COMMERCIAL WASTE, AND BALLAST WATER

Subpart C--Ballast Water Management for Control of Nonindigenous
Species in the Great Lakes and Hudson River

    1. The authority citation for subpart C continues to read as
follows:

    Authority: 16 U.S.C. 4711; Department of Homeland Security
Delegation No. 0170.1.

    2. In Sec.  151.1504, add, in alphabetical order, definitions for
the terms ``Ballast Water Management System (BWMS)'' and ``Build date''
to read as follows:

Sec.  151.1504  Definitions.

* * * * *
    Ballast Water Management System (BWMS) means any system which
processes ballast water to kill or remove organisms. The BWMS includes
all ballast water treatment equipment and all associated control and
monitoring equipment.
* * * * *
    Build date means the date when construction identifiable with the
specific vessel begins; or assembly of the vessel has commenced
comprising at least 50 tons or 1 percent of the estimated mass of all
structural material, whichever is less; or the ship undergoes a major
conversion.
* * * * *
    3. Add 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.
    4. Revise Sec.  151.1510(a)(1) and (3) to read as follows:

Sec.  151.1510  Ballast water management.

    (a) * * *
    (1) Carry out an exchange of ballast water on the waters beyond the
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, prior
to entry into the Snell Lock, at Massena, New York, or prior to
navigating on the Hudson River, north of the George Washington Bridge,
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 implement an approved BWMS per the
schedule found in Sec.  151.1512 of this subpart.
* * * * *
    (3) Use a ballast water management system (BWMS) that has been
approved by the Coast Guard. Requests for approval of BWMS must be
submitted to the Commanding Officer, U.S. Coast Guard Marine Safety
Center, Jemal Building, JR 10-0525, 2100 Second Street, SW.,
Washington, DC 20593.
    (i) Requirements for approval of BWMS are found in 46 CFR 162.060-
10.
    (ii) 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, at all times of discharge
into the waters of the United States, meet the applicable ballast water
discharge standard (BWDS) found in Sec.  151.1511 of this subpart.
* * * * *
    5. Add Sec.  151.1511 to read as follows:

Sec.  151.1511  Ballast water discharge standard (BWDS).

    (a) Vessels employing a Coast Guard approved BWMS must meet the
following phase-one BWDS by the date listed in Table 151.1512(b) in
section 151.1512 of this subpart:
    (1) For organisms larger than 50 microns in minimum dimension:
Discharge less than 10 per cubic meter of ballast water;
    (2) For organisms equal to or smaller than 50 microns and larger
than 10 microns: Discharge less than 10 per milliliter (ml) of ballast
water; and
    (3) Indicator microorganisms must not exceed:
    (i) For Toxicogenic Vibrio cholerae (serotypes O1 and O139): A
concentration of <1 colony forming unit (cfu) per 100 ml;
    (ii) For Escherichia coli: A concentration of <250 cfu per 100 ml;
and
    (iii) For intestinal enterococci: A concentration of <100 cfu per
100 ml.
    (b) Vessels employing a Coast Guard approved BWDS must meet the
following phase-two BWDS by the date listed in Table 151.1512(c) in
section 151.1512 of this subpart:
    (1) For organisms larger than 50 microns in minimum dimension:
discharge less than 1 per 100 cubic meter of ballast water;
    (2) For organisms equal to or smaller than 50 microns and larger
than 10 microns: Discharge less than 1 organism per 100 milliliter (ml)
of ballast water;
    (3) For organisms less than 10 microns in minimum dimension:
    (i) Discharge less than 103 living bacterial cells per 100 ml of
ballast water; and
    (ii) Discharge less than 104 viruses or viral-like particles per
100 ml of ballast water; and
    (4) Indicator microorganisms must not exceed:
    (i) For Toxicogenic Vibrio cholerae (serotypes O1 and O139): A
concentration of <1 colony forming unit (cfu) per 100 ml;
    (ii) For Escherichia coli: A concentration of <126 cfu per 100 ml;
and
    (iii) For intestinal enterococci: A concentration of <33 cfu per
100 ml.
    (c)(1) The Coast Guard shall, at least three years prior to the
first compliance date set forth in Table 151.1512(c) in section
151.1512 of this subpart, publish the results of a practicability
review to determine whether--
    (i) Technology to comply with the performance standard required
under paragraph (b) of this section can practicably be implemented, in
whole or in part, by the applicable compliance dates; and
    (ii) Testing protocols that can assure accurate measurement of
compliance with the performance standard required under paragraph (b)
of this section can practicably be implemented.
    (2) If the Coast Guard cannot make a determination under paragraph
(c)(1) of this section for some or all elements of the performance
standard listed in paragraph (b) of this section, the Coast Guard
shall, at the same time that it publishes the results of the
practicability review, extend the initial compliance date, in
accordance with the Administrative Procedure Act, in Table 151.1512(c)
for the applicable elements of the performance standard, taking into
consideration the findings of the practicability review.
    (3) If the Coast Guard cannot make a determination under paragraph
(c)(1) of this section for some or all elements of the performance
standard under paragraph (b) of this section, the Coast Guard shall
update the practicability review, consistent with the requirements of
paragraph (c)(1) of this section, as appropriate, but at least every
two years, until the performance standard under paragraph (b) of this
section is fully implemented.
    (4) If the Coast Guard finds, as a result of a practicability
review under either paragraphs (c)(1) or (c)(3) of this section, that
technology to achieve a significant improvement in treatment efficacy,
either greater or less than the efficacy of the performance standards
in paragraph (b) of this section can practicably be implemented, as
outlined in paragraph (c)(1) of this section, the Coast Guard shall
report this finding in the practicability review and propose an
appropriate revision to the applicable requirements of this subpart.
    6. Redesignate Sec.  151.1512 as Sec.  151.1513, and add a new
Sec.  151.1512 to read as follows:

Sec.  151.1512  Implementation schedule.

    (a) The master, owner, operator, agent, or person-in-charge of the
vessel subject to this subpart and wishing to discharge ballast within
U.S. waters must install and operate a Ballast Water Management System
(BWMS) approved by the Coast Guard under 46 CFR part 162 in accordance
with Table 151.1512(b) ``Implementation Schedule for the Phase-One
Ballast Water Management Program'' of this section and Table
151.1512(c) ``Implementation Schedule for the Phase-Two Ballast Water
Management Program'' of this section, as applicable. 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.
    (b) Table 151.1512(b) Implementation Schedule for the Phase-One
Ballast Water Management Program

----------------------------------------------------------------------------------------------------------------
  Vessel's  ballast water  capacity     Vessel's  construction    Vessel's compliance
         (cubic meters, m\3\)                    date                     date
----------------------------------------------------------------------------------------
New vessels..........................  All....................  On or after January 1,   On delivery.
                                                                 2012.
Existing vessels.....................  Less than 1500.........  Before January 1, 2012.  First drydocking after
                                                                                January 1, 2016.
                                       1500-5000..............  Before January 1, 2012.  First drydocking after
                                                                                January 1, 2014.
                                       Greater than 5000......  Before January 1, 2012.  First drydocking after
                                                                                January 1, 2016.
----------------------------------------------------------------------------------------------------------------

    (c) Table 151.1512(c) Implementation Schedule for the Phase-Two
Ballast Water Management Program

----------------------------------------------------------------------------------------------------------------
  Vessel's  ballast water  capacity     Vessel's  construction    Vessel's compliance
         (cubic meters, m\3\)                    date                     date
----------------------------------------------------------------------------------------
New vessels..........................  All....................  On or after January 1,   On delivery.
                                                                 2016.
Existing vessels.....................  All....................  Before January 1, 2016.  First drydocking after
                                                                                January 1, 2016,
                                                                                UNLESS the vessel
                                                                                installed a BWMS
                                                                                meeting the phase-one
                                                                                standard before
                                                                                January 1, 2016, then
                                                                                5 years after
                                                                                installation of the
                                                                                BWMS meeting the phase-
                                                                                one standard.
----------------------------------------------------------------------------------------------------------------

    7. 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, the following information, in
written form, to the COTP.
* * * * *
    8. Revise Subpart D 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.
151.2030 Ballast water discharge standard (BWDS).
151.2035 Implementation schedule for approved ballast water
management system (BWMS).
151.2040 Discharge of ballast water in extraordinary circumstances.
151.2045 Safety exception.
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