Part IV

As Enacted ( Federal Register)

Cited authorities 12

Cited in

Federal Register: August 28, 2009 (Volume 74, Number 166)

Proposed Rules

Page 44631-44672

From the Federal Register Online via GPO Access [wais.access.gpo.gov]

DOCID:fr28au09-27

Page 44631

Part IV

Department of Homeland Security

Coast Guard

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

Page 44632

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.

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 202-366-9329.

(4) Fax: 202-493-2251.

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 202-372-1433. Copies of the material are available as indicated in the ``Incorporation by Reference'' section of this preamble.

FOR FURTHER INFORMATION CONTACT: If you have questions on this proposed rulemaking, call or e-mail Mr. John Morris, Project Manager,

Environmental Standards Division, U.S. Coast Guard Headquarters, telephone 202-372-1433, e-mail John.C.Morris@uscg.mil. 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

Submitting Comments
Viewing Comments and Documents
Privacy Act
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
Executive Order 12866
Small Entities
Assistance for Small Entities
Collection of Information
Federalism
Unfunded Mandates Reform Act
Taking of Private Property
Civil Justice Reform

I. Protection of Children
Indian Tribal Governments
Energy Effects

L. Technical Standards
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.
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.
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.
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).
Public Meeting

We have determined that public meetings would aid this rulemaking.

Consequently, we plan to hold public

Page 44633

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.

\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.

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

Page 44634

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
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.

Page 44635
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.
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).

Page 44636

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.
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 10 --------------------------------------------------------------------------

Large organisms >50 and 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

Page 44641

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.

Page 44642
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.
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

Page 44643

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.

Page 44644

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.

Page 44645

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''.
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.
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).

Page 44646
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.
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.
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.
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.
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.
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.
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.
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

Page 44647

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

Page 44648

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 iso, which can be derived as follows:

GRAPHIC

TIFF OMITTED TP28AU09.085

Where:

DMis the diameter of the main pipe from which samples are to be extracted;

QMis the flow rate in the main pipe; and

Qisois the desired sample flow rate.

(ii) The sample port size must be based on the combination of maximum sample flow rate and minimum main-pipe flow rate that yields the largest isokinetic diameter.

(iii) Samples must be drawn from a straight pipe section on the centerline of the main flow, looking into the flow.

(iv) The sample taken should be drawn from the main pipe at a location where the flowing stream at the sample point is representative of the contents of the flow in the main pipe. The sample port should be located at a point where the flow in the main pipe is as close to fully mixed and fully developed as practicable.

(v) Ball valves must be used for shutting off the flow.

(vi) Smooth transition flow controls, like flexible venturi, must be used to control flow rates.

(viii) Piping and fittings from the sample port to the sample collection vessel must be minimized.

(t) Samples should be collected for:

(1) Organisms of greater than or equal to 50 micrometers in size from at least 20 liters of influent water and 1,000 liters of treated water, in triplicate, respectively. If samples are concentrated for enumeration, the samples should be concentrated using a sieve no greater than 50 micrometer mesh in the diagonal dimension;

(2) Organisms greater than or equal to 10 micrometers and less than 50 micrometers in size from at least 1 liter of influent water and at least 10 liters of treated water, in triplicate, respectively. If samples are concentrated for enumeration, the samples should be concentrated using a sieve no greater than 10 micrometers mesh in the diagonal dimension; and

(3) Escherichia coli, enterococci, Vibrio cholerae, and heterotrophic bacteria from at least 500 milliliters of influent and treated water collected in sterile bottles, in triplicate, respectively.

(u) All applicable environmental parameters such as pH, temperature, salinity, DO, TSS, DOC, POC, and turbidity must be measured at the same time samples are taken.

(v) The control and treatment test cycles may be run simultaneously or sequentially. Control samples are to be taken in the same manner as treatment samples, upon influent and discharge.

(w) The samples must be analyzed in such a way so that post collection mortality is minimized and proper analyses can be performed to determine the number of living organisms relative to the specifications of the discharge standard. Validation of the methods used must be made in the Test Plan required under Sec. 162.060-24 of this subpart.

(x) Efficacy testing and sample analysis is meant to determine the number of living organisms in the samples both before and after treatment. The methods for the collection, handling, storage, and analysis of samples must be clearly cited and described in the Test

Plan, and they must include detection, enumeration, and identification of test organisms used for determining viability. When standard methods are not available for particular organisms or taxonomic groups, methods that are developed for use must also be described in detail in the Test

Plan and include any experiments conducted to validate the use of the methods. At a minimum--

(1) The efficacy of a proposed BWMS must be tested by means of standard scientific methodology in the form of controlled experiments;

(2) The efficacy of the BWMS must be determined by comparing the concentration of organisms in the treated discharge with the values of the BWDS specified in 33 CFR part 151, subparts C and D;

(3) Any statistical analyses of BWMS performance must include power analyses to evaluate the ability of the tests to detect differences;

(4) If, in any test cycle, the average organism concentration in challenge water is less than 10 times the maximum permissible values of the BWDS required in 33 CFR part 151, subparts C and D, the test cycle is invalid;

(5) If, in any test cycle, the average organism concentration in discharged control water is less than the maximum permissible values of the BWDS required in 33 CFR part 151, subparts C and D, the test cycle is invalid; and

(6) Different samples may be taken for determination of the concentration and viability of organisms in the different groups specified in the BWDS required in 33 CFR part 151, subparts C and D.

(y) Live/dead judgment must be determined by appropriate industry or government standards or methods approved by the Coast Guard, including, but not limited to morphological change, mobility, reaction to stimulus, or staining using vital dyes or molecular techniques.

(z) All replicate samples collected within a valid set of test cycles must meet the BWDS required in 33 CFR part 151, subparts C and

D.

Sec. 162.060-28 Shipboard testing requirements.

(a) The BWMS manufacturer is responsible for making all arrangements

Page 44668

for a vessel on which to conduct shipboard tests.

(b) In addition to the land-based tests required in Sec. 162.060- 26 of this subpart, each BWMS approved under this subpart must undergo shipboard tests and evaluations that meet the requirements of this section. The shipboard testing will verify:

(1) That the BWMS under consideration for approval consistently results in the routine discharge of ballast water that meets the BWDS requirements of part 151, subparts C and D; and

(2) That the operating and maintenance parameters identified by the manufacturer in the Operation, Maintenance, and Safety Manual are consistently achieved.

(c) The vessel used as a platform for shipboard testing under this section must be selected so that:

(1) The volumes and rates of ballast water used and treated are representative of the upper end of the treatment rated capacity for which the BWMS is intended to be used;

(2) The circumstances of the vessel's operation during the period of shipboard testing provide an acceptable range of geographic and seasonal variability conditions.

(i) During testing, the ballast water used by the vessel and treated by the BWMS for the purposes of the shipboard tests must come from at least 3 different geographic locations that lie in non- neighboring marine biogeographical provinces (e.g., the IUCN Marine

Ecoregions of the World, as published in the journal BioScience, 2007,

Vol. 57 No. 7; or the Briggs and Eckman bioprovinces, as published in

Briggs, J.C., 1995, Global biogeography. Developments in paleontology and stratigraphy, Elsevier Science, Amsterdam.)

(ii) Shipboard tests must be conducted throughout a 12 month period.

(3) The ports visited by the vessel provide adequate availability of transportation and scientific support needed to accomplish the necessary sampling and analytical procedures during the shipboard tests.

(d) The vessel's ballast water system must be provided with sampling ports arranged in order to collect representative samples of the ship's ballast water.

(1) In addition to the sampling ports requirements found in 162.060-26, sampling ports must be located:

(i) As close as practicable to the BWMS prior to testing and prior to the discharge point after testing to determine concentrations of living organisms upon uptake and prior to discharge; and

(ii) Elsewhere as necessary to ascertain the proper functioning of the BWMS;

(2) As close to the overboard outlet as possible.

(e) The efficacy of the BWMS must be tested during at least ten valid test cycles.

(1) A test cycle entails:

(i) The uptake of ballast water of the ship; the storage of ballast water on the ship;

(ii) Treatment of the ballast water by the BWMS, except in control tanks; and

(iii) The discharge of ballast water from the ship.

(2) All test cycles will include quantification of the water quality parameters on uptake;

(3) Three test cycles will entail full experimental tests and consist of quantification of the concentration of living organisms in the ballast water on uptake and at discharge from the treatment and control tanks;

(4) Seven test cycles will consist of discharge tests and of quantification of the concentration of living organisms in the treated ballast water on discharge. No control tanks are required;

(5) Valid test cycles are as follows:

(i) For full experimental test cycles, uptake water for both the control tank and ballast water to be treated must have living organism concentrations exceeding ten times the threshold values of BWDS required in 33 CFR part 151, subparts C and D, and control tank living organism concentrations must exceed the values of the BWDS on discharge;

(ii) For full experimental test cycles and discharge test cycles, the BWMS must operate successfully as designed, maintaining control of all set points and treatment processes, including any pre-discharge conditioning to remove or neutralize residual treatment chemicals or by-products; and

(iii) For full experimental test cycles and discharge test cycles, all design or required water quality parameters must be met for the discharged water;

(6) The source water for all test cycles must be characterized by measurement of water quality parameters as follows:

(i) For all BWMS tests, salinity, temperature, and turbidity must be measured at the beginning, middle, and end of the period of ballast water uptake; and

(ii) BWMS that make use of active substances or other processes that are affected by specific water quality parameters (e.g., dissolved and particulate organic material, pH, etc.), or water quality parameters identified by the manufacturer and/or the IL as being critical must be measured at the beginning, middle, and end of the period of ballast water uptake.

(f) Samples of ballast water must be collected from in-line sampling ports in either of two ways:

(1) Three replicate samples of water, collected at three discrete periods of time over the entire period of uptake or discharge (e.g. beginning, middle, end) as appropriate; or

(2) One flow averaged sample of at least 1 cubic meter collected over the entire period of uptake or discharge.

(g) The following information must be documented during all BWMS testing operations conducted on the vessel:

(1) All ballast water operations, including volumes and locations of uptake and discharge;

(2) All weather conditions and resultant effects on vessel orientation and vibration;

(3) Temperature of the BWMS;

(4) Scheduled maintenance performed on the system;

(5) Unscheduled maintenance and repair performed on the system;

(6) Data for all engineering parameters monitored as appropriate to the specific system;

(7) Consumption of all solutions, preparations, or other consumables necessary for the effective operation of the BWMS; and

(8) All parameters necessary for tracking the functioning of the control and monitoring equipment.

(h) All measurements for numbers and viability of organisms, water quality parameters, engineering performance parameters, and environmental conditions must be conducted:

(1) As described in Sec. 162.060-26 (w) and (x) of this subpart, using standard methods from recognized bodies such as EPA (in 40 CFR part 136), the International Standards Organization, or others accepted by the scientific community, or

(2) Using validated methods approved in advance by the Coast Guard.

The possible reasons for the occurrence of an unsuccessful test cycle due to obvious mechanical or process failure or a test cycle discharge failing the discharge standard should be investigated and reported.

Sec. 162.060-30 Testing requirements for ballast water management system (BWMS) components.

(a) The electrical and electronic components, including each alarm and control and monitoring device of the BWMS, must be subjected to the following environmental tests when in the standard production configuration:

Page 44669

(1) A resonance search vertically up and down, horizontally from side to side, and horizontally from end to end, at a rate sufficiently low to permit resonance detection made over the following ranges of oscillation frequency and amplitude:

(i) 2 to 13.3 Hz with a vibration amplitude of 1 mm;

(ii) 13.2 to 80 Hz with an acceleration amplitude of 0.7 g;

(2) The components must be vibrated in the above mentioned planes at each major resonant frequency for a period of 4 hours.

(3) In the absence of any resonant frequency, the components must be vibrated in each of the planes at 30 Hz with an acceleration of 0.7 g for a period of 4 hours.

(4) Components that may be installed in exposed areas on the open deck or in enclosed spaces not environmentally controlled must be subjected to a low temperature test of -25 [deg]C and a high temperature test of 55 [deg]C for a period of two hours.

(5) Components that may be installed in enclosed spaces that are environmentally controlled, including an engine-room, must be subjected to a low temperature test at 0 [deg]C and a high temperature test at 55

deg

C, for a period of two hours. At the end of each test, the components are to be switched on and must function normally under the test conditions.

(6) Components should be switched off for a period of two hours at a temperature of 55 [deg]C in an atmosphere with a relative humidity of 90%. At the end of this period, the components should be switched on and should operate satisfactorily for one hour under the test conditions.

(7) Components that may be installed in exposed areas on the open deck must be subjected to tests for protection against heavy seas in accordance with IP 56 of publication IEC 529 (incorporated by reference; see Sec. 162.060-5) or its equivalent.

(8) Components must operate satisfactorily with a voltage variation of 10% together with a simultaneous frequency variation of 5%, and a transient voltage of 20% together with a simultaneous transient frequency of 10% and transient recovery time of 3 seconds.

(9) The components of a BWMS must be designed to operate when the ship is upright and inclined at any angle of list up to and including 15[deg] either way under static conditions and 22.5[deg] under dynamic, rolling conditions either way and simultaneously inclined dynamically

(pitching) 7.5[deg] by bow or stern. Deviation from these angles may be permitted only upon approval of a written waiver submitted to the Coast

Guard in accordance with 162.060-10(h), taking into consideration the type, size and service conditions and locations of the ships and operational functioning of the equipment for where the system will be used. Any deviation permitted must be documented in the Type Approval

Certificate.

(10) The same component(s) must be used for each test required by this section, and testing must be conducted in the order in which the tests are described, unless otherwise authorized by the Coast Guard.

(b) There shall be no cracking, softening, deterioration, displacement, breakage, leakage, or damage of components or materials that affects the operation or safety of the BWMS after each test. The components must remain operable after all tests.

Sec. 162.060-32 Testing and evaluation requirements for Active

Substances, Preparations, and Relevant chemicals.

(a) A BWMS may not use an active substance or preparation that is a pesticide unless the sale and distribution of such pesticide is authorized under the Federal Insecticide, Fungicide, and Rodenticide

Act (FIFRA) for use in ballast water treatment, prior to submission to the Coast Guard for approval of the BWMS. This requirement does not apply to the use of active substances or preparations generated solely by the use of a device (as defined under FIFRA) on board the same vessel as the ballast water to be treated.

(b) A BWMS that uses an active substance or preparation that is not a pesticide, or that uses a pesticide that is generated solely by the use of a device (as defined under FIFRA) on board the same vessel as the ballast water to be treated, must prepare an assessment demonstrating the effectiveness of the BWMS for its intended use, appropriate dosage, hazards of the BWMS, and means for protection of the environment, and public health. This assessment must accompany the application package submitted to the Coast Guard.

Sec. 162.060-34 Test Report requirements.

(a) The final results of all approval tests and evaluations must be presented in a Test Report prepared by the Independent Laboratory (IL).

(b) The Test Report must include all data regarding test conditions, quality control measures, results of all approval tests and evaluations, and all data or information supplied by the manufacturer regarding the performance of the system. The Test Report must contain all information required by 46 CFR 159.005-11 and include applicable sections for all land-based, shipboard, component, active substance, preparations and relevant chemical tests, and evaluations.

(c) The Test Report must include a summary statement that presents the IL's assessment based on the tests and evaluations conducted. The summary statement should state if the BWMS--

(i) Has been shown under the procedures and conditions specified in this subpart to meet the Ballast Water Discharge Standard requirements of 33 part 151, subparts C and D;

(ii) Is designed and constructed according to the requirements of

Sec. 162.060-20 of this subpart;

(iii) Is in compliance with all applicable U.S. Environmental

Protection Agency (EPA) regulations; and

(iv) Operates at the rated capacity, performance, and reliability as specified by the manufacturer.

(d) The Test Report for a BWMS that may incorporate, use, produce, generate as a by-product and/or discharge hazardous materials, active substances, relevant chemicals and/or pesticides during its operation must include the following information in the appendix of the Test

Report:

(1) A list of each active substance or preparation used in the

BWMS. For each active substance or preparation that is a pesticide and is not generated solely by the use of a device on board the same vessel as the ballast water to be treated, the appendix must also include documentation that the sale or distribution of the pesticide is authorized under FIFRA for use for ballast water treatment. For all other active substances or preparations, the appendix must include documentation of the assessment specified at Section 162.060-32(b);

(2) A list of all active substances, preparations, and relevant chemicals, along with the results of all tests conducted; and

(3) A list of all hazardous materials, including the applicable hazard classes, proper shipping names, reportable quantities as designated by 40 CFR 117.1, and chemical names of all components.

(e) The Test Report must contain the following documentation:

(1) The Operation, Maintenance, and Safety Manual meeting the requirements of Sec. 162.060-38 for the BWMS specific to the vessel where testing was conducted, with a technical description of the BWMS, operational and maintenance procedures, backup

Page 44670

procedures in case of equipment malfunction, installation specifications, installation commissioning procedures, and any initial calibration procedures.

(2) Verification that--

(i) The BWMS installation has been carried out in accordance with the technical installation specification;

(ii) Any operational inlets and outlets are located in the positions indicated on the drawing of the pumping and piping arrangements;

(iii) The workmanship of the installation is satisfactory and, in particular, that any bulkhead penetrations or penetrations of the ballast system piping are to the relevant approved standards;

(iv) The control and monitoring equipment operates correctly;

(v) The BWMS's capacity is within the range of the Treatment Rated

Capacity for which it is intended; and

(vi) The amount of ballast water treated in the test cycle is consistent with the normal ballast operations of the ship, and that the

BWMS was operated at the Treatment Rated Capacity for which it is intended to be approved.

(f) The Test Report must contain the following information:

(1) Summary Statement;

(2) Executive Summary;

(3) Introduction and Background;

(4) Description of the BWMS;

(5) For each test conducted--

(i) Description of the test conditions;

(ii) Experimental design;

(iii) Methods and procedures; and

(iv) Results and discussion;

(6) Appendices, including--

(i) Test Plans;

(ii) Manufacturer supplied Operation, Maintenance and Safety Manual meeting the requirements of Sec. 162.060-38;

(iii) Data generated during testing & evaluations;

(iv) Quality assurance and controls records;

(v) Maintenance logs;

(vi) Relevant records and tests results maintained or created during testing;

(vii) Information on hazardous materials, active substances, and relevant chemicals and pesticides; and

(viii) Permits, registrations, restrictions, and regulatory limitations on use.

Sec. 162.060-36 Quality Assurance Project Plan (QAPP) requirements.

The approval testing and evaluation process must contain a rigorous quality control and assurance program consisting of a Quality Assurance

Project Plan (QAPP) developed in accordance with ISO/IEC 17025, General

Requirements for the Competence of Calibration and Testing

Laboratories. The Independent Laboratory performing approval tests and evaluations is responsible for ensuring the appropriate quality assurance and quality control procedures are implemented.

Sec. 162.060-38 Operation, Maintenance, and Safety Manual (OMSM).

(a) Each BWMS submitted for approval must include an Operation,

Maintenance, and Safety Manual (OMSM), which includes a complete description of the BWMS, information on the treatment process[es], design criteria, physical configuration, electrical, instrumentation, control systems, operating instructions, maintenance requirements, and all health and safety issues.

(b) Each OMSM must include the following sections:

(1) Table of contents.

(2) Manufacturer's information.

(3) Principles of system operation including--

(i) A complete description of the BWMS, methods and type[s] of technologies used in each treatment stage of the BWMS;

(ii) The theory of operation;

(iii) Any process or technology limitations;

(iv) Performance ranges and expectations of the system; and

(v) A description of the locations and conditions for which the

BWMS is intended.

(4) Major system components and shipboard application including--

(i) A general description of the materials used when constructing and installing the BWMS;

(ii) A detailed description of the onboard physical configuration of the BWMS and how it will be physically integrated with shipboard ballast systems at all stages of ballast water treatment; general arrangement of installed equipment; utility connections such as power, water, and air; interfaces with shipboard systems; and required connections to a vessel's piping systems and foundations;

(iii) A list of each major component that may be fitted differently in different vessels with a general description of the different arrangements schemes;

(iv) The range of vessel sizes, classes, and operations for which it is intended;

(v) Any vessel type[s], services or locations where the system is not intended to be used;

(vi) Maximum and minimum flow and volume capacities of the system;

(vii) The dimensions and weight of the complete system and required connection and flange sizes for all major components;

(viii) A description of all actual or potential effects of the BWMS on the vessel's ballast water, ballast water tanks, and ballast water piping and pumping systems;

(ix) A list of all active substances, relevant chemicals, and pesticides generated or stored onboard the vessel to be used by the

BWMS; and

(x) Information on whether the BWMS is designed to be used in hazardous locations as defined in the NEC (incorporated by reference; see Sec. 162.060-5) and in IEC 79-0 (incorporated by reference; see

Sec. 162.060-5).

(5) System and major system component drawings as applicable under 46 CFR Sec. 56.01-10(b), including--

(i) Process flow diagram(s) of the BWMS showing the main treatment processes, chemicals, and monitoring and control devices for the BWMS;

(ii) Footprint(s), drawings, and system schematics showing all major components and arrangements;

(iii) Drawings of the pumping and piping arrangements, power panels, and all equipment provided with the BWMS;

(iv) All treatment application points, waste or recycling streams, and all sampling points integral to the specific BWMS;

(v) All locations and the sizes of all piping and utility connections for power, water, compressed air or other utilities as required by the BWMS;

(vi) Detailed electrical plans of each relevant component of the

BWMS as described in 46 CFR 110.25-1 and electrical/electronic wiring diagrams that include the location and electrical rating of power supply panels and BWMS control and monitoring equipment;

(vii) Unit(s), construction materials, standards and labels on all drawings of equipment, piping, instruments, and appurtenances; and

(viii) An index of all drawings and diagrams.

(6) A description of the BWMS's control and monitoring equipment and how it will be integrated with the existing shipboard ballast system, including--

(i) Power demand;

(ii) Main and local control panels;

(iii) Power distribution system;

(iv) Power quality equipment;

(v) Instrumentation and control system architecture;

(vi) Process control description;

(vii) Operational set points, control loops, control algorithms, and alarm settings for routine, maintenance, and emergency operations; and

Page 44671

(viii) All devices required for measuring appropriate parameters such as: Pressure, temperature, flow rate, water quality, power, and chemical residuals.

(7) A description of all relevant standard operating procedures including, but not limited to:

(i) System start-up and system shutdown procedures and times;

(ii) Emergency shutdown and system by-pass procedures;

(iii) Requirements to achieve treatment objectives (e.g., time following initial treatment, critical dosages, residual concentrations, etc);

(iv) Operating, safety, and emergency procedures;

(v) System limitations, precautions, and set points;

(vi) Detailed instructions on operation, calibration and zeroing of each monitoring device used with the system;

(vii) Personnel requirements for the BWMS including number and types of personnel needed, labor burden, and operator training or specialty certification requirements.

(8) A description of the preventive and corrective maintenance requirements of the BWMS, including:

(i) Inspection and adjustment procedures;

(ii) Troubleshooting procedures;

(iii) An illustrated list of parts and spare parts;

(iv) A list of recommended spare parts to have during installation and operation of the BWMS;

(v) Use of tools and test equipment in accordance with the maintenance procedures; and

(vi) Point[s] of contact for technical assistance.

(9) A description of the health and safety risks to the personnel associated with the installation, operation, and maintenance of the

BWMS including, but not limited to:

(i) The storage, handling, and disposal of any hazardous wastes;

(ii) Any health and safety certification/training requirements for personnel operating the BWMS; and

(iii) All material safety data sheets for hazardous or relevant chemicals used, stored or generated by or for the system.

(c) If any information in the OMSM changes as a result of approval testing and evaluations, a new OMSM must be submitted.

Sec. 162.060-40 Requirements of Independent Laboratories (IL).

(a) Each request for designation as an Independent Laboratory (IL) authorized to perform approval tests must either be delivered by visitors or through the mail to the Commandant (CG-521), Office of

Design and Engineering Standards, 2nd Street, SW., Washington, DC 20593, in a written or electronic format.

(b) Each request must include the following:

(1) Name and address of the IL;

(2) Each type of equipment the IL proposes to test; and

(3) A description of the IL's capability to perform approval tests including detailed information on the following:

(i) Management organization, including personnel qualifications;

(ii) Equipment available for conducting sample analysis;

(iii) Materials available for approval testing;

(iv) Each of the IL's test rigs; and

(v) Disposal procedures for all treated and control water.

(c) The Coast Guard will review each request submitted to determine whether the IL meets the requirements of this section.

(d) To obtain authorization to conduct approval tests--

(1) An IL must have the management organization, equipment for conducting sample analysis, and the materials necessary to perform the tests;

(2) The loss or award of a specific contract to test equipment must not be a substantial factor in the IL's financial well being; and

(3) The IL must be free of influence and control of the manufacturers and suppliers of the equipment.

(e) Each test and evaluation must be performed by the IL and accepted by the Coast Guard. A list of independent laboratories accepted by the Coast Guard may be found at http://cgmix.uscg.mil/, or may be obtained by contacting the Commandant (CG-521), 2100 2nd Street,

SW., Washington, DC 20593. ILs may not be subcontracted by an IL for

BWMS approval testing unless previously authorized by the Coast Guard.

If the IL identified in the application requests authorization to subcontract approval tests or evaluations, the Coast Guard must evaluate the suitability of each identified IL prior to conducting any tests or evaluations required under this subpart. A request for authorization to subcontract must be sent to the Commandant (CG-521), 2100 2nd Street, SW., Washington, DC 20593.

(f) Upon receipt of the approval application, the IL will conduct a readiness evaluation and determine the acceptability for testing.

(g) The readiness evaluation will examine the design and construction of the BWMS to determine whether there are any fundamental problems that might constrain the ability of the BWMS to manage ballast water as proposed by the manufacturer or to operate it safely onboard vessels. This evaluation must consider the following:

(1) The health and safety of the crew, including potential long term effects as determined by the EPA;

(2) Any potential adverse environmental effects as determined by the EPA;

(3) Interactions with vessel systems and cargo and the potential impacts to a vessel, including effects on corrosion in the ballast water system and other spaces;

(h) To be approved for testing and evaluations, a BWMS must:

(1) Be designed and constructed according to the requirements of

Sec. 162.060-20;

(2) Meet the definition of a complete BWMS, as defined in this subpart, to include both ballast water treatment equipment and control and monitoring equipment. Only complete systems in the configurations in which they are intended for sale and use will be accepted for approval testing. The Coast Guard will not separately approve treatment, control, or monitoring components; and

(3) Meet all existing safety and environmental regulatory requirements for all locations and conditions where the system will be operated during the testing and evaluation period.

(i) The IL has the right to reject a proposed BWMS for testing and evaluation if it does not satisfy the requirements in (h), is not deemed ready for approval testing and evaluations, or, if for technical or logistical reasons, that IL does not have the capabilities to accommodate the BWMS for testing or evaluation.

(j) For each approval test to be completed, the IL must prepare a written test plan in accordance with Sec. 162.060-24.

(k) Upon notification by the IL that the BWMS is acceptable for testing, the manufacturer must provide a complete BWMS for testing and evaluation to the IL.

(l) For all land-based tests, the BWMS must be set up in accordance with the BWMS Operation, Maintenance and Safety Manual, with respect to mounting water supply and discharge fittings.

(m) Prior to commencing land-based or shipboard testing required under this subpart, the manufacturer must sign a written statement to attest that the system was properly assembled and installed at the IL or onboard the test vessel.

(n) All approval testing and evaluations must be conducted in

Page 44672

accordance with testing requirements of this subpart and within the range or rated capacity of the BWMS.

(o) Upon completion of all approval tests and evaluations, the IL must follow the requirements of 46 CFR 159.005-9(a)(5) and ensure a complete Test Report is forwarded to the Commanding Officer, U.S. Coast

Guard Marine Safety Center, Jemal Building, JR 10-0525, 2100 Second

Street, SW., Washington, DC 20593.

Dated: August 17, 2009.

Thad W. Allen,

Admiral, U.S. Coast Guard, Commandant.

FR Doc. E9-20312 Filed 8-27-09; 8:45 am

BILLING CODE 4910-15-P

Subscribers can access the reported version of this case.

You can sign up for a trial and make the most of our service including these benefits.

Request your trial

Why Sign-up to vLex?

Over 100 Countries

Search over 120 million documents from over 100 countries including primary and secondary collections of legislation, case law, regulations, practical law, news, forms and contracts, books, journals, and more.
Thousands of Data Sources

Updated daily, vLex brings together legal information from over 750 publishing partners, providing access to over 2,500 legal and news sources from the world’s leading publishers.
Find What You Need, Quickly

Advanced A.I. technology developed exclusively by vLex editorially enriches legal information to make it accessible, with instant translation into 14 languages for enhanced discoverability and comparative research.
Over 2 million registered users

Founded over 20 years ago, vLex provides a first-class and comprehensive service for lawyers, law firms, government departments, and law schools around the world.

Subscribers are able to see a list of all the cited cases and legislation of a document.

You can sign up for a trial and make the most of our service including these benefits.

Request your trial

Why Sign-up to vLex?

Over 100 Countries

Search over 120 million documents from over 100 countries including primary and secondary collections of legislation, case law, regulations, practical law, news, forms and contracts, books, journals, and more.
Thousands of Data Sources

Updated daily, vLex brings together legal information from over 750 publishing partners, providing access to over 2,500 legal and news sources from the world’s leading publishers.
Find What You Need, Quickly

Advanced A.I. technology developed exclusively by vLex editorially enriches legal information to make it accessible, with instant translation into 14 languages for enhanced discoverability and comparative research.
Over 2 million registered users

Founded over 20 years ago, vLex provides a first-class and comprehensive service for lawyers, law firms, government departments, and law schools around the world.

Subscribers are able to see a list of all the documents that have cited the case.

You can sign up for a trial and make the most of our service including these benefits.

Request your trial

Why Sign-up to vLex?

Over 100 Countries

Search over 120 million documents from over 100 countries including primary and secondary collections of legislation, case law, regulations, practical law, news, forms and contracts, books, journals, and more.
Thousands of Data Sources

Updated daily, vLex brings together legal information from over 750 publishing partners, providing access to over 2,500 legal and news sources from the world’s leading publishers.
Find What You Need, Quickly

Advanced A.I. technology developed exclusively by vLex editorially enriches legal information to make it accessible, with instant translation into 14 languages for enhanced discoverability and comparative research.
Over 2 million registered users

Founded over 20 years ago, vLex provides a first-class and comprehensive service for lawyers, law firms, government departments, and law schools around the world.

Subscribers are able to see the revised versions of legislation with amendments.

You can sign up for a trial and make the most of our service including these benefits.

Request your trial

Why Sign-up to vLex?

Over 100 Countries

Search over 120 million documents from over 100 countries including primary and secondary collections of legislation, case law, regulations, practical law, news, forms and contracts, books, journals, and more.
Thousands of Data Sources

Updated daily, vLex brings together legal information from over 750 publishing partners, providing access to over 2,500 legal and news sources from the world’s leading publishers.
Find What You Need, Quickly

Advanced A.I. technology developed exclusively by vLex editorially enriches legal information to make it accessible, with instant translation into 14 languages for enhanced discoverability and comparative research.
Over 2 million registered users

Founded over 20 years ago, vLex provides a first-class and comprehensive service for lawyers, law firms, government departments, and law schools around the world.

Subscribers are able to see any amendments made to the case.

You can sign up for a trial and make the most of our service including these benefits.

Request your trial

Why Sign-up to vLex?

Over 100 Countries

Search over 120 million documents from over 100 countries including primary and secondary collections of legislation, case law, regulations, practical law, news, forms and contracts, books, journals, and more.
Thousands of Data Sources

Updated daily, vLex brings together legal information from over 750 publishing partners, providing access to over 2,500 legal and news sources from the world’s leading publishers.
Find What You Need, Quickly

Advanced A.I. technology developed exclusively by vLex editorially enriches legal information to make it accessible, with instant translation into 14 languages for enhanced discoverability and comparative research.
Over 2 million registered users

Founded over 20 years ago, vLex provides a first-class and comprehensive service for lawyers, law firms, government departments, and law schools around the world.

Subscribers are able to see a visualisation of a case and its relationships to other cases. An alternative to lists of cases, the Precedent Map makes it easier to establish which ones may be of most relevance to your research and prioritise further reading. You also get a useful overview of how the case was received.

Request your trial

Why Sign-up to vLex?

Over 100 Countries

Search over 120 million documents from over 100 countries including primary and secondary collections of legislation, case law, regulations, practical law, news, forms and contracts, books, journals, and more.
Thousands of Data Sources

Updated daily, vLex brings together legal information from over 750 publishing partners, providing access to over 2,500 legal and news sources from the world’s leading publishers.
Find What You Need, Quickly

Advanced A.I. technology developed exclusively by vLex editorially enriches legal information to make it accessible, with instant translation into 14 languages for enhanced discoverability and comparative research.
Over 2 million registered users

Founded over 20 years ago, vLex provides a first-class and comprehensive service for lawyers, law firms, government departments, and law schools around the world.

Subscribers are able to see the list of results connected to your document through the topics and citations Vincent found.

You can sign up for a trial and make the most of our service including these benefits.

Request your trial

Why Sign-up to vLex?

Over 100 Countries

Search over 120 million documents from over 100 countries including primary and secondary collections of legislation, case law, regulations, practical law, news, forms and contracts, books, journals, and more.
Thousands of Data Sources

Updated daily, vLex brings together legal information from over 750 publishing partners, providing access to over 2,500 legal and news sources from the world’s leading publishers.
Find What You Need, Quickly

Advanced A.I. technology developed exclusively by vLex editorially enriches legal information to make it accessible, with instant translation into 14 languages for enhanced discoverability and comparative research.
Over 2 million registered users

Founded over 20 years ago, vLex provides a first-class and comprehensive service for lawyers, law firms, government departments, and law schools around the world.

Part IV

You can sign up for a trial and make the most of our service including these benefits.

Why Sign-up to vLex?

Over 100 Countries

Thousands of Data Sources

Find What You Need, Quickly

Over 2 million registered users

You can sign up for a trial and make the most of our service including these benefits.

Why Sign-up to vLex?

Over 100 Countries

Thousands of Data Sources

Find What You Need, Quickly

Over 2 million registered users

You can sign up for a trial and make the most of our service including these benefits.

Why Sign-up to vLex?

Over 100 Countries

Thousands of Data Sources

Find What You Need, Quickly

Over 2 million registered users

You can sign up for a trial and make the most of our service including these benefits.

Why Sign-up to vLex?

Over 100 Countries

Thousands of Data Sources

Find What You Need, Quickly

Over 2 million registered users

You can sign up for a trial and make the most of our service including these benefits.

Why Sign-up to vLex?

Over 100 Countries

Thousands of Data Sources

Find What You Need, Quickly

Over 2 million registered users

Why Sign-up to vLex?

Over 100 Countries

Thousands of Data Sources

Find What You Need, Quickly

Over 2 million registered users

You can sign up for a trial and make the most of our service including these benefits.

Why Sign-up to vLex?

Over 100 Countries

Thousands of Data Sources

Find What You Need, Quickly

Over 2 million registered users