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

DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 151

46 CFR Part 162

[Docket No. USCG-2001-10486]

RIN 1625-AA32

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

AGENCY:

Coast Guard, DHS.

ACTION:

Final rule.

SUMMARY:

The Coast Guard is amending its regulations on ballast water management by establishing a standard for the allowable concentration of living organisms in ships' ballast water discharged in waters of the United States. The Coast Guard is also amending its regulations for engineering equipment by establishing an approval process for ballast water management systems. These new regulations will aid in controlling the introduction and spread of nonindigenous species from ships' ballast water in waters of the United States.

DATES:

This final rule is effective June 21, 2012 except for 33 CFR 151.1513 and 151.2036 which contains information collection requirements that OMB has not approved. The Coast Guard will publish a document in the

Federal Register

announcing the effective date. Comments sent to the Office of Management and Budget (OMB) on collection of information must reach OMB on or before May 22, 2012. The incorporation by reference of certain publications listed in the rule is approved by the Director of the Federal Register on June 21, 2012.

ADDRESSES:

Comments and material received from the public, as well as documents mentioned in this preamble as being available in the docket, are part of docket USCG-2001-10486 and are available for inspection or copying at the Docket Management Facility (M-30), U.S. Department of Transportation, West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue SE., Washington, DC 20590, between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. You may also find this docket on the Internet by going to

http://www.regulations.gov,

inserting USCG-2001-10486 in the “Keyword” box, and then clicking “Search.”

Collection of Information Comments.

If you have comments on the collection of information discussed in section VII.D of this final rule, you must send comments to the Office of Information and Regulatory Affairs (OIRA), OMB. To ensure that OIRA receives your comments on time, you should submit your comments through the preferred methods of email to

oira_submission@omb.eop.gov

(include the docket number and “Attention: Desk Officer for Coast Guard, DHS” in the subject line of the email) or fax at 202-395-6566. An alternate, though slower, method is by U.S. mail to the OIRA, OMB, 725 17th Street NW., Washington, DC 20503, Attn: Desk Officer, U.S. Coast Guard.

Viewing incorporation by reference material.

You may inspect the material incorporated by reference at U.S. Coast Guard Headquarters, 2100 2nd St. SW., Washington, DC 20593 between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The telephone number is 202-372-1433. Copies of the material are available as indicated in the “Incorporation by Reference” section of this preamble.

FOR FURTHER INFORMATION CONTACT:

If you have questions on this rule, call or email Mr. John Morris, Project Manager, U.S. Coast Guard; telephone 202-372-1433, email

John.C.Morris@uscg.mil.

If you have questions on viewing or submitting material to the docket, call Renee V. Wright, Program Manager, Docket Operations, telephone 202-366-9826.

SUPPLEMENTARY INFORMATION:

Table of Contents for Preamble

I. Abbreviations

II. Regulatory History

III. Basis and Purpose

IV. Background

V. Discussion of Comments and Changes

A. Summary of Changes From the NPRM

1. Deferral of Phase-Two Standard

2. Practicability Reviews

3. Applicability

4. COTP Zone Exemption

5. Removal of Ballast Water Reporting Form From CFR

6. Adoption of ETV Protocol

7. Alternate Management Systems and Foreign Approvals

8. Delay of Compliance Date for New Vessels

9. Other Changes

B. Discussion of Comments

1. Applicability

2. Ballast Water Discharge Standard

3. Ballast Water Management Systems

4. Type-Approval Protocols

5. Legal

6. Regulatory Analysis and Initial Regulatory Flexibility Analysis

7. Draft Programmatic Environmental Impact Statement

8. Beyond the Scope

VI. Incorporation by Reference

VII. Regulatory Analyses

A. Regulatory Planning and Review

B. Small Entities

C. Assistance for Small Entities

D. Collection of Information

E. Federalism

F. Unfunded Mandates Reform Act

G. Taking of Private Property

H. Civil Justice Reform

I. Protection of Children

J. Indian Tribal Governments

K. Energy Effects

L. Technical Standards

M. Environment

I. Abbreviations

APA Administrative Procedure Act

APHIS U.S. Department of Agriculture's Animal and Plant Health Inspection Service

AMS alternate management system

BWDS ballast water discharge standard(s)

BWE ballast water exchange

BWM ballast water management

BWMS ballast water management system(s)

cfu colony forming unit(s)

COTP Captain of the Port

CSLC California State Lands Commission

DPEIS Draft Programmatic Environmental Impact Statement

DSA Danish Shipowners' Association

EEZ U.S. Exclusive Economic Zone

EIS Environmental Impact Statement

EPA U.S. Environmental Protection Agency

ESA Endangered Species Act

ETV Environmental Technology Verification

FIFRA Federal Insecticide, Fungicide, and Rodenticide Act

FPEIS Final Programmatic Environmental Impact Statement

FR final rule

GRT gross register tons

GSI Great Ships Initiative

GT gross tons

IEC International Electrotechnical Commission

IL Independent Laboratory

IMO International Maritime Organization

IRFA Initial Regulatory Flexibility Analysis

ISO International Organization for Standardization

ITC International Convention on Tonnage Measurement of Ships, 1969

MSC Marine Safety Center

NANPCA Nonindigenous Aquatic Nuisance Prevention and Control Act of 1990

NARA National Archives and Records Administration

NBIC National Ballast Information Clearinghouse

NEPA National Environmental Policy Act

NFPA National Fire Protection Association

NIS nonindigenous species

NISA National Invasive Species Act of 1996

NPDES National Pollutant Discharge Elimination System

NPRM notice of proposed rulemaking

NRC National Research Council

OPA Oil Pollution Act of 1990, as amended

OMB Office of Management and Budget

PEIS Programmatic Environmental Impact Statement

PVA population viability analysis

PSU practical salinity unit

PWS RCAC Prince William Sound Regional Citizens' Advisory Council

RA Regulatory Analysis

ROS reduced operating status

SAB Science Advisory Board

SBA Small Business Administration

SNPRM supplemental notice of proposed rulemaking

STEP Shipboard Technology Evaluation Program

UV ultraviolet radiation

VGP Vessel General Permit

VHS Viral Hemorrhagic Septicemia

II. Regulatory History

On August 28, 2009, the Coast Guard published a notice of proposed rulemaking (NPRM) entitled “Standards for Living Organisms in Ships' Ballast Water Discharged in U.S. Waters” in the

Federal Register

(74 FR 44632). In response, we received 662 letters to the docket for the rulemaking, which contained 2,214 individual comments on the NPRM. We summarize these comments in the preamble of this final rule (

see

V.B. Discussion of Comments).

We held six public meetings on the NPRM in the following locations: Seattle, WA; New Orleans, LA; Chicago, IL; Washington, DC; Oakland, CA; and New York, NY. Comments received at those meetings, both written and oral, are also summarized in this preamble (

see

V.B. Discussion of Comments).

III. Basis and Purpose

The Nonindigenous Aquatic Nuisance Prevention and Control Act of 1990 (NANPCA), as amended by the National Invasive Species Act of 1996 (NISA), requires the Secretary of Homeland Security to ensure to the maximum extent practicable that aquatic nuisance species are not discharged into waters of the United States from vessels. 16 U.S.C. 4711(c)(2)(A). The statutes further stipulate that the Secretary may approve the use of certain alternative ballast water management (BWM) methods if she determines that those alternative methods are at least as effective as ballast water exchange (BWE) in preventing and controlling infestations of aquatic nuisance species. 16 U.S.C. 4711(c)(2)(D)(iii). The Secretary is further required to direct vessels to carry out management practices necessary to reduce the probability of unintentional discharges resulting from ship operations other than ballast water discharge. 16 U.S.C. 4711(c)(2)(E).

NISA also requires the Secretary to assess and, if dictated by that assessment, to revise the Department's BWM regulations not less than every 3 years based on the best scientific information available to her at the time of that review, and potentially to the exclusion of some of the BWM methods listed at 16 U.S.C. 4711(c)(2)(D). 16 U.S.C. 4711(e). The Commandant of the Coast Guard carries out these functions and authorities for the Secretary pursuant to a delegation of authority charging the Coast Guard with establishing and enforcing regulations to prevent the introduction and spread of aquatic nuisance species in the waters of the United States through the ballast water of vessels. Department of Homeland Security Delegation No. 0170.1(II.)(57).

Determining whether an alternative method of BWM is as effective as BWE is not an easy task. Results from several studies have shown the effectiveness of BWE varies considerably and is dependent on vessel type (design), exchange method, ballasting system configuration, exchange location, and method of study. These variables make comparing the effectiveness of an alternative BWM method to the effectiveness of BWE extremely difficult. Some studies suggest that the efficacy of BWE in reducing organism concentration is 80 to 99 percent per event (Hines and Ruiz 2000; Rigby and Hallegraeff 1993; Smith et al. 1996; Taylor and Bruce 2000; Zhang and Dickman 1999) although lower efficacies have been reported (e.g., Dickman and Zhang 1999). Other studies demonstrate that the volumetric efficiency of BWE ranges from 50 to 90 percent (Battelle 2003; USCG 2001; Zhang and Dickman 1999).

1

Thus, vessels with very large starting concentrations of organisms in their ballast tanks might still have large concentrations of organisms after BWE. In addition, a significant number of vessels are constrained by design or route from conducting BWE in compliance with existing regulations prior to their arrival into waters of the United States.

1

Copies of these studies are available in Docket No. USCG-2001-10486, and were available during the comment period following publication of the NPRM for this rulemaking. Please see

ADDRESSES

section of this rulemaking for accessibility information.

For these reasons, BWE is not well-suited as the basis for the protective BWM programmatic regimen envisioned by NISA, even though it has been a useful interim management practice and was a logical place to start. We have concluded that, as an alternative method to using BWE as the benchmark, establishing a standard for the concentration of living organisms that can be discharged in ballast water will advance the protective intent of NISA and simplify the process for Coast Guard approval of ballast water management systems (BWMS). We have found no other reasonable benchmarking approach.

We have further concluded, through analysis of BWMS on vessels enrolled or being reviewed for the Coast Guard Shipboard Technology Evaluation Program (STEP) and other information before the Coast Guard which is in the docket for this rulemaking, in accordance with the factors set forth in 151.1511(c) and 151.2030(c) of this final rule, that the specific ballast water discharge standard (BWDS) set forth in this rule is practicable.

Setting a BWDS promotes the development of innovative BWM technologies, facilitates enforcement of the BWM regulations, and assists in evaluating the effectiveness of the BWM program. Therefore, in this rule, we amend 33 CFR part 151 by establishing a BWDS. We also amend 46 CFR part 162 by adding an approval process for BWMS intended for use onboard vessels to meet the BWDS.

As part of that approval process, the Coast Guard will require the use of Independent Laboratories (ILs) to perform the testing to be used to support applications for approval. The Coast Guard has a long history of recognizing the qualifications of ILs working under our oversight. In 1979, the Coast Guard promulgated 46 CFR part 159, establishing procedures and standards for accepting ILs for witnessing or performing certain tests and conducting inspections for certain equipment and materials requiring Coast Guard approval. 44 FR 73038 (December 17, 1979). The Coast Guard promulgated 46 CFR part 159 under the authority in 46 U.S.C. 391a (1976) (Vessels carrying certain cargoes in bulk).

2

In 1983, Congress revised and recodified the maritime laws of the United States and moved the relevant authority for 46 CFR

part 159 to new 46 U.S.C. 3306.

3

Public Law 98-89 Partial Revision of Title 45, U.S.C. “Shipping”; House Report No. 98-338 (August 1, 1983), 1983 U.S.C.C.A.N. 924, 952-53.

2

46 U.S.C. 391a stated “(3) Rules and regulations[.] In order to secure effective provision (A) for vessel safety, and (B) for protection of the marine environment, the Secretary of the department in which the Coast Guard is operating * * * shall establish for the vessels to which this section applies such additional rules and regulations as may be necessary with respect to the design and construction, alteration, repair, and maintenance of such vessels, including, * * * equipment * * * .” The Coast Guard determined that the use of ILs for witnessing or performing certain tests was “necessary” to carry out its responsibilities under this statutory section. In the NPRM proposing 46 CFR part 159, the Coast Guard explained that “the Coast Guard's marine inspection responsibilities increased while the number of personnel available to perform these inspections has not increased at a comparable rate.” (43 FR 49440, Oct. 23, 1978). The Coast Guard promulgated part 159 to “free some of the Coast Guard's limited field personnel for other duties with no change in the quality of the approved equipment or material.”

Id.; see

also 44 FR 73038 (December 17, 1979) (Final rule document promulgating part 159).

3

Section 3306 directs “the Secretary shall prescribe necessary regulations to ensure proper execution of, and to carry out, this part [addressing inspection and regulation of vessels] in the most effective manner for (1) The design, construction, alteration, repair, and operation of those vessels [subject to inspection] * * *; (2) lifesaving equipment and its use; (3) firefighting equipment, its use, and precautionary measures to guard against fire; (4) inspections and tests related to paragraphs (1), (2), and (3) of this subsection; and (5) the use of vessel stores and other supplies of a dangerous nature * * *.”

The authority for current 46 CFR part 159 is 46 U.S.C. 3306, which “contains broad authority to prescribe regulations for proper inspection and certification of vessels,” (House Report No. 98-338 (August 1, 1983), 1983 U.S.C.C.A.N. 924, 954-53), including the specific requirement to prescribe regulations to carry out the statutory requirements “in the most effective manner,” (46 U.S.C. 3306(a)). The Coast Guard still finds the use of ILs in the Coast Guard's approval process to be “the most effective manner” of executing and carrying out its obligations under section 3306.

IV. Background

A full discussion of the legislative and regulatory history of the Coast Guard's actions to implement both NANPCA and NISA may be found in the NPRM for this rule, published on August 28, 2009. 74 FR 44632, 44633.

Vessels subject to today's final rule are also subject to the U.S. Environmental Protection Agency (EPA) Vessel General Permit (VGP) issued under section 402 of the Clean Water Act. The Coast Guard and EPA continue to work closely together in the development of ballast water discharge standards and to harmonize requirements, to the extent feasible and appropriate, under their respective statutory mandates. Under the CWA, EPA proposed the new draft VGP for public comment on November 30, 2011, with a proposed effective date of December 2013.

The draft EPA VGP contains discharge limits for a number of discharges incidental to the normal operation of vessels operating in a capacity as a means of transportation, including numeric limits for ballast water discharges. The Coast Guard notes that the draft VGP proposes to apply numeric treatment limits for ballast water discharges to a broader class of vessels than this final rule. Like the 2008 VGP, the draft 2013 VGP proposes some requirements that are broader in applicability, require additional management requirements, and require differing monitoring or other quality control requirements from today's rulemaking. The 2008 VGP applied requirements to tankers in the coastwise trade and required ballast water exchange for vessels engaged in Pacific nearshore voyages, among other ballast water requirements that differed from the Coast Guard regulation in effect in 2008. The Coast Guard notes that EPA must consider the information in its record, as well as the requirements of the Clean Water Act, as it finalizes the VGP. Therefore, it is possible that the final VGP will contain requirements that differ from those found in our rulemaking today.

For more information on EPA's current VGP or its next draft VGP, visit the EPA's Web site at:

http://www.epa.gov/npdes/vessels.

Nothing in this final rule is intended to limit, in any way, actions the EPA may take in the future with respect to regulation of ballast water discharge in the EPA VGP under its Clean Water Act authorities.

See, e.g.,

16 U.S.C. 4711(b)(2)(C) and 4711(c)(2)(J).

V. Discussion of Comments and Changes

A. Summary of Changes From the NPRM

This final rule contains a number of changes from the rule proposed by the NPRM (74 FR 44632 (August 28, 2009)). While we list in this section all changes made to the rule since the NPRM, we are highlighting several of these changes not only because they are important, but also because a vast majority of the comments received in the docket addressed at least one of these topics. Most of the changes discussed below were made directly in response to those comments. A full discussion of comments and Coast Guard responses is found in section V.B. Discussion of Comments.

1. Deferral of Phase-Two Standard

Most notably, this final rule does not include the NPRM's proposed phase-two standard. This reflects a decision to move forward with the phase-one standard while the Coast Guard continues to assess the practicability of implementing a phase-two standard, gathers additional data on technology available to meet the phase-two standard for various vessel types, and develops a subsequent rule with an economic and environmental analysis to support a phase-two standard. The decision to remove this more stringent standard from this final rule should not be interpreted as a sign that the Coast Guard is not committed to its statutory responsibility to continually review the BWDS to increase the protectiveness of the BWDS.

Significantly, after this final rule was drafted, the EPA requested its Science Advisory Board (SAB) to review and provide advice regarding whether existing shipboard treatment technologies can reach specified concentrations of organisms in vessel ballast water, how these technologies might be improved in the future, and how to overcome limitations in existing data (EPA SAB 2011). Information was identified on 51 existing or developmental ballast water treatment technologies, although detailed data were available for only 15 specific BWMS. The SAB used this information as the source material for its assessment of ballast water treatment performance and, as requested by the EPA, used proposed ballast water discharge standards as the performance benchmarks. Based on its evaluation of the available data, the SAB concluded that the performance standards for discharge quality proposed by IMO and the Coast Guard are currently measurable, based on data from land-based and shipboard testing. However, current methods (and associated detection limits) prevent testing of BWMS to any standard more stringent than D-2/Phase 1 and make it impracticable for verifying a standard 100 or 1,000 times more stringent. New or improved methods will be required to increase detection limits sufficiently to statistically evaluate a standard 10 times more stringent than IMO D-2/Phase 1; such methods may be available in the near future. The SAB concluded that establishment of a ballast water discharge limit at the proposed Coast Guard Phase I/IMO discharge standard will result in a substantial reduction in the concentration of living organisms in the vast majority of ballast water discharges, compared to discharges of ballast water managed by mid-ocean exchange or discharges of unexchanged ballast water. The numeric limitations in today's final rule represent the most stringent standards that BWMS currently safely, effectively, credibly, and reliably meet (US EPA SAB, 2011.)

The cost, benefit, and environmental impact analyses included in the NPRM could not specifically assess all impacts related to the phase-two standard (although the analyses did include an evaluation of standards that are more stringent than the standard proposed herein as practicable). Many commenters addressed this issue, noting that the lack of analyses made it

impossible for them to comment on the phase-two standard in any meaningful manner.

To provide the public with as much information as possible on which to base comments, the Coast Guard will develop additional analyses regarding the potential costs, benefits, and environmental impacts of the proposed phase-two standard or any standard higher than phase-one. When these analyses are completed, the Coast Guard will make them available for public comment, either via a notice of availability or in conjunction with a subsequent rulemaking published in the

Federal Register

.

The Coast Guard still fully intends to issue a later rule that will establish a more stringent phase-two discharge standard once the additional research and analysis necessary to support this more stringent standard has been completed. To demonstrate our commitment, in the final rule text we are reserving the regulatory provisions where the phase-two standard will be found, to show that the Coast Guard does not view publication of this rule as completing the agency's work in controlling the introduction and spread of NIS from ships' ballast water.

2. Practicability Reviews

The NPRM proposed an initial practicability review to be published at least 3 years prior to the first compliance date under the BWDS implementation schedule, with a subsequent review no later than 2 years after the initial review. Because we have removed the phase-two standard from this final rule, we have also removed the recurring practicability reviews that were included in the NPRM. This final rule establishes clearer guidelines and criteria considered for the practicability review. Additionally, because the final rule defers establishing a phase-two standard, we wanted to prevent the scenario in which a finalized phase-two standard believed to be practicable when established should not be implemented according to the established timelines, either because it can be implemented sooner or because it cannot be implemented by the deadline established. To accomplish this, NISA requires regular reviews and strengthening of standards when determined practicable, so completing a review will be part of any future rulemaking. See 16 U.S.C. 4711(e).

This final rule does include one practicability review provision, which requires the Coast Guard to complete and publish the results of its practicability review no later than January 1, 2016. This review will draw a significant component of its information from the BWMS approval application packages that the Coast Guard expects to evaluate between the publication date of this final rule and the initial implementation date. The Coast Guard's practicability review will look at a variety of factors, including but not limited to economic factors and the efficacy and environmental safety of available BWMS technology. While we have listed a number of these factors in this final rule, we have also included a provision allowing us to consider additional factors. This is to ensure that the Coast Guard is not foreclosed from considering any unforeseen issues.

Some commenters argued against considering any factor other than best available technology. Whether the commenters meant “best available technology” as a term of art under the Clean Water Act or merely the best technology available in the marketplace, the Coast Guard acknowledges the importance of technology. However, the Coast Guard's authority does not limit the matters of concern to technology. Congress established a practicability standard in NISA; that standard requires that the Coast Guard consider more than just technology. A standard based solely on technology would be inconsistent with the statute.

3. Applicability

In the NPRM, we proposed requiring vessels discharging ballast water into waters of the United States to comply with the BWDS. This included vessels operating solely in coastwise trade and on the internal waters of the United States. Those vessels are not required to conduct a BWE under the existing Coast Guard regulations, and, as such, the proposal was seen as an expansion of those regulations. A large number of commenters questioned this expansion.

Commenters raised a number of issues regarding the applicability of the NPRM. These issues included uncertainty as to whether any of the currently available BWMS could be successfully installed on non-seagoing vessels, the cost of installation of BWMS on these industries, and the benefit of requiring these vessels to install a BWMS.

As a result of these comments, this final rule applies to two groups of vessels discharging ballast water into waters of the United States. The first group is comprised of those vessels currently required to conduct BWE. The second group, which previously was not required to conduct BWE, is comprised of seagoing vessels that do not operate beyond the U.S. Exclusive Economic Zone (EEZ), that take on and discharge ballast water in more than one Captain of the Port (COTP) Zone, and are greater than 1,600 gross register tons (GRT) (3,000 gross tons (GT) International Tonnage Convention (ITC)).

The Coast Guard fully intends to expand the applicability of the BWDS to all vessels not legislatively exempted that operate in U.S. navigable waters or territorial sea, as we proposed in the NPRM, but we have determined that additional analysis is necessary to support this expansion. We also intend to conduct additional research as necessary. We expect that this expansion will be part of the notice or other rulemaking document that addresses the phase-two standard, and that vessels covered by the expanded applicability will be required to install a BWMS that meets at least the phase-one standard.

In addition to the comments on applicability mentioned above, we also received comments questioning why we proposed using the presence of ballast tanks as the main applicability factor for BWMS installation, instead of the actual discharge of ballast water. We agree an important factor in deciding whether a vessel is required to have a BWMS onboard should be the threat that vessel presents to contributing to the threat of aquatic NIS. Vessels that pose a low level of risk, either because they do not discharge ballast water at all, discharge only to shoreside facilities, or discharge only water that presents little threat (public drinking water), should not be required to install a BWMS. For this reason, we revised 33 CFR 151.1510 and 151.2025 to (1) clarify that discharge of ballast water into waters of the U.S. is a threshold requirement for installation of a BWMS, and (2) include an additional BWM option for use of water from a U.S. public water supply meeting certain EPA drinking water standards. We have also slightly revised the applicability section in 33 CFR part 151 subpart C (Ballast Water Management for Control of Nonindigenous Species in the Great Lakes and Hudson River). We inserted a provision to clearly state that all vessels subject to subpart C are also subject to 33 CFR part 151 subpart D (Ballast Water Management for Control of Nonindigenous Species in Waters of the United States). This does not reflect an actual change to the regulations, as the general applicability provision in subpart D already applies to vessels subject to subpart C. Subpart D requires that these vessels comply with additional NIS reduction practices and the reporting and recordkeeping requirements. We are adding the clarifying statement to subpart C in order to ensure there is no confusion about the applicability of subparts C and

D. We made other slight modifications to align the applicability section of subpart C with that of subpart D, but these revisions do not change the substantive requirements of either subpart.

4. COTP Zone Exemption

Existing BWM regulations include a provision that exempts owners and operators of vessels operating in only one COTP Zone from reporting and recordkeeping requirements. 33 CFR 151.2010(b)(1). In the NPRM, we intended to remove this exemption from the reporting and recordkeeping requirements, but include an exemption from the BWDS for owners and operators of these vessels (those operating in only one COTP Zone). We explained this exemption by stating that “it is unlikely that vessels operating in only one COTP Zone would introduce invasive species (from outside of that COTP Zone) into the waters of the COTP Zone.” 74 FR 44634.

Unfortunately, the proposed regulatory text included erroneous cross references, did not actually exempt these vessels from the intended provisions, and did not remove the current reporting and recordkeeping exemption. This error confused many commenters. Other commenters based their comments on our intentions as stated in the preamble, and noted that COTP Zones are purely administrative in nature, not established based on any ecological or biological bases, and therefore are not appropriate boundaries to be used when addressing invasive species.

Because we have revised the applicability of this final rule, as discussed above, the BWDS will not apply to vessels operating within only one COTP Zone. However, we do intend to expand the applicability of the BWM requirement to include all vessels operating in waters of the United States that are not legislatively exempted, but have determined that additional analysis is necessary to support such an expansion. We also intend to conduct additional research as necessary. The issue of whether there are distinct zones or areas where it might be appropriate to include an exemption for vessels that do not leave that zone or area is still open to consideration as part of a subsequent notice or other rulemaking document.

Many commenters supported the concept of geographic exemptions; however, some objected to using COTP Zones as the basis for the exemption. For this reason, the Coast Guard will investigate other possible ways to create an exemption like this, using suggestions from commenters and our Federal agency partners.

We are also keeping intact the current exemption from recordkeeping and reporting requirements for these vessels which operate exclusively in one COTP Zone. We will, in the future, begin a separate rulemaking project addressing BWM recordkeeping and reporting requirements, and any changes to this exemption will be addressed in that project.

5. Removal of Ballast Water Reporting Form From CFR

We have removed the Ballast Water Reporting Form (Office of Management and Budget (OMB) Control No. 1625-0069) from the appendix to 33 CFR part 151 subpart D. This form is still the proper form to satisfy the reporting requirements in 33 CFR 151.2070. We have revised § 151.2070 to reference the National Ballast Information Clearinghouse (NBIC) Web site as the form's location. This change will not have any effect on the public, as the form will still be available and the requirement for filing the form is not being revised.

We have removed this form from the CFR in order to streamline future changes to the form. Any changes would need to comply with provisions of the Paperwork Reduction Act (44 U.S.C. 3501

et seq.

), which include providing notice to the public and opportunity for comment. Additionally, the form is part of an OMB-approved collection of information that must be renewed on a regular basis. These renewals also include an opportunity for public notice and comment on the form and the associated collection of information.

6. Adoption of Environmental Technology Verification (ETV) Protocol

In the NPRM, we noted that our proposed BWMS approval process was based, in part, on the draft Generic Protocol for the Verification of Ballast Water Treatment Technologies developed under EPA's ETV Program. 74 FR 44640 (Aug. 28, 2009). Since the publication of the NPRM, EPA has completed its development of this protocol, a process that included laboratory testing, stakeholder reviews, and public comment. The protocol may be found on the EPA Web site, under Research and Development, Risk Management Research Publications.

4

The Coast Guard and EPA have been formal partners in the process of developing this protocol. It has always been our intention to incorporate the final ETV Protocol into our BWMS approval process, which we are doing via this final rule.

4

EPA/600/R-10/146, version 5.1 (September 2010). Available at

http://www.epa.gov/nrmrl/pubs/600r10146/600r10146.pdf

.

While this incorporation was not part of the proposal included in the NPRM, we noted that the procedures in the NPRM were based on a preliminary version of the ETV Protocol (74 FR 44634, 44640). While the final ETV Protocol differs from earlier versions, the differences are due both to consensus revisions during finalization of the protocol, and to subsequent peer review and public comments. Some of the comments we received on the NPRM specifically suggested that we use the final ETV Protocol.

For all of these reasons, the Coast Guard has determined that incorporating the final ETV Protocol into this final rule is a logical outgrowth of what was proposed in the NPRM, and that further notice and comment on incorporating it by reference is not required.

5

We have revised the approval process regulations to incorporate the final ETV Protocol, and have removed those portions of the regulation that were made redundant by this incorporation.

5

See Int'l Union, United Mine Workers of Amer.

v.

Mine Safety and Health Admin.,

626 F.3d 84, 95 (D.C. Cir. 2010) (“a final rule will be deemed to be the logical outgrowth of a proposed rule if a new round of notice and comment would not provide commenters with their first occasion to offer new and different criticisms which the agency might find convincing.”) (internal citations omitted).

7. Alternate Management System(s) (AMS) and Foreign Approvals

The NPRM included a provision to allow foreign type-approved BWMS to receive U.S. type approval subject to an equivalency determination. We have removed that provision in this final rule; however, we still allow manufacturers to use testing done to obtain type approval from a foreign administration, and the data from that testing, to satisfy the U.S. type-approval testing and application requirements if the Coast Guard determines the testing to be equivalent to what is required by our regulation. The language in 46 CFR 162.060-12 was revised; we have included more detail as to what a manufacturer with a foreign-approved BWMS must show in order to use their prior testing to satisfy our approval requirements, rather than vaguely calling for the manufacturer to show equivalency. Despite these revisions, the intent and effect of the changes are substantially similar to what appeared in the NPRM. As such, we view these changes as logical outgrowths of the

NPRM, and thus further notice and comment is not required.

Despite the provision discussed in the previous paragraph, we are aware that many foreign-approved BWMS will require additional testing in addition to analysis under applicable U.S. environmental laws, such as the National Environmental Policy Act (NEPA) and the Endangered Species Act (ESA). This is due to differences between the international approval regime and the approval protocol adopted in the final rule. This will extend the amount of time required for foreign-approved systems to gain U.S. approval, although the process to secure U.S. approval should still be shorter than if the manufacturer were required to repeat all testing already completed for obtaining type approval from a foreign administration.

Implementing the U.S. approval process will likely take at least 3 years. We do not anticipate having U.S. approved systems that have satisfied the testing protocols required in 46 CFR subpart 162.060 prior to 2015.

To ensure there are BWMS available for vessel installation and use without having to delay the implementation schedule, and also to provide an incentive for the early installation and use of BWMS instead of relying exclusively on BWE, we have added a provision to 33 CFR 151.1510(a)(1), 151.2025(a)(3), and included a new provision (§ 151.2026) and definition (§ 151.1504) to allow for the temporary acceptance of foreign-approved BWMS, providing the Coast Guard determines that the BWMS is at least as effective as BWE. These alternate management systems (AMS) must be approved by foreign governments under the standards set forth in the International Convention for the Control and Management of Ships Ballast Water and Sediments (IMO BWM Convention), after it enters into force, or consistent with relevant guidelines developed by the IMO. This provision for AMS will also allow vessels with BWMS installed to meet requirements of other administrations and/or the standards set forth in the IMO BWM Convention to use such BWMS while operating in waters of the United States. We further note that pursuant to § 151.2025(e) of this final rule, any vessel using an AMS must comply with the terms and conditions of the VGP when operating in U.S. waters, including any applicable discharge limitations.

As with the process for U.S. approval of foreign-approved BWMS, these temporary acceptance determinations will be subjected to reviews under NEPA, ESA, and other environmental policy laws. However, we expect the AMS process will require less time than the more extensive type approval process, which will allow vessel owners to install BWMS prior to the implementation dates contained in the regulation. These earlier installations should result, at the earliest possible date, in a reduction of the risk of ballast water introducing or spreading NIS, as those vessels currently unable to conduct BWE due to safety concerns or voyage constraints will instead be subjecting their ballast water to some type of treatment before discharging it into the waters of the United States.

Use of an AMS will be allowed for up to 5 years after the vessel is required to comply with the BWDS. The 5-year period should provide the manufacturer or vendor with sufficient time to obtain U.S. approval, either using the data from the tests already completed, or by undergoing new tests designed specifically to comply with 46 CFR part 162.060.

8. Delay of Compliance Date for New Vessels

Even with the provision for acceptance of foreign type approvals, a process that is expected to be quicker than completing the full schedule of land-based and shipboard tests, we anticipate there will not be an adequate number of approved BWMS to allow vessel owners to meet the NPRM's proposed compliance date for new vessels. For this reason, we have pushed back the compliance date for new vessels to install Coast Guard-approved BWMS from January 1, 2012, to December 1, 2013. Additionally, the December 1st date will align the compliance date with the proposed effective date for the 2013 EPA VGP. We estimate this deferral could delay the compliance date for up to 600 newly constructed vessels.

We have also added a provision to both 33 CFR part 151 subparts C and D that will allow individual vessel owners to request that the Coast Guard extend their compliance date if, despite the owner's efforts, he or she cannot meet the published compliance dates. This change is in response to commenters who argued that the compliance timelines included in the NPRM were too aggressive.

9. Other Changes

The Coast Guard made additional changes in response to comments, and some of those changes warrant a summary here. The remaining changes are listed at the end of this section and discussed further in section V.B. Discussion of Comments.

First, we are adding a requirement to 33 CFR 151.2075 for sampling ports on each of the vessel's overboard ballast water discharge pipes. This change is a response to commenters who requested stronger enforcement and commenters who asked how enforcement would be achieved. Without the inclusion of sampling ports, Coast Guard inspectors would not be able to sample a vessel's ballast water without potentially delaying the vessel for significant periods of time. Sampling is necessary in order to determine if the BWMS is operating properly to produce ballast water that meets the BWDS. The inclusion of sampling ports is logical outgrowth of the NPRM because the Coast Guard must have means to ensure compliance, and the NPRM included a provision requiring vessel owners and operators to provide access to the Coast Guard for sampling. Also, commenters asked how enforcement would be achieved. Inclusion of this requirement improves Coast Guard enforcement and responds to both groups of these commenters.

Secondly, we received questions from commenters asking who should operate the BWMS during the shipboard testing. We have clarified in 46 CFR 162.060-28 that it should be the vessel crew operating the BWMS. This is most appropriate because the crewmembers are the ones who will need to operate the BWMS after it receives U.S. type approval. Additionally, having the crew operate the BWMS ensures that vendors and manufacturers, who have a stake in the success of the BWMS, are not able to influence the test results. This provision is a logical outgrowth of the NPRM because the NPRM listed the vessel crew as one of two groups that should operate the BWMS during testing. This change is a clarification to show which of those listed entities should operate the BWMS during land-based testing, and which should operate the BWMS during shipboard testing.

Finally, in response to comments, we reduced the time period required for shipboard testing from 12 months to 6 months, removed the requirement for testing to be in three distinct geographic regions, and reduced the number of required, valid test cycles. Several commenters requested these changes, noting that our proposed requirements were unnecessary and too burdensome. We agree that the suggested changes will still provide for adequate shipboard testing of BWMS, therefore, we have made these changes to reduce the burden associated with shipboard testing.

The remaining changes made in response to comments were replacing

the term “build date” with “constructed”, in order to better align with the IMO BWM Convention and updating the civil penalty amounts to reflect their adjustment in a recent Coast Guard final rule.

The Coast Guard made several changes during the drafting of this final rule to eliminate redundancy and streamline the regulatory text. We revised the definitions section in 33 CFR part 151 subpart D by removing those definitions that are already defined in part 151 subpart C, as well as definitions for terms not used in part 151 subpart D. We added definitions for several terms that were used in 46 CFR subpart 162.060, and we updated the incorporation by reference section in that subpart to more clearly indicate those standards being incorporated into this regulation.

We deleted 33 CFR 151.2075(c), which referred to an assessment of vessel compliance with the now obsolete voluntary national program. That assessment has been completed for several years; therefore, it is no longer necessary to refer to it in the regulations.

We revised § 151.1510(a)(1) to clarify when BWE must be conducted. We also revised paragraphs (a)(3) and (d) of that section to improve readability and clarify requirements. Similar revisions were made in § 151.2025, also to improve readability and clarify requirements.

We corrected the BWDS in both subparts C and D to align with the IMO BWM Convention.

We removed proposed 33 CFR 151.2045 “Safety exceptions,” as we determined that those provisions were largely repetitive to what was proposed in 33 CFR 151.2040, entitled “Discharge of ballast water in extraordinary circumstances.” We moved the one non-repetitive provision to § 151.2040. As a result, § 151.2040 now includes the provision noting that nothing in the regulations relieves the master, owner, agent, or person in charge of the vessel from any responsibility, including the safety and stability of the vessel and the safety of the crew and passengers.

Throughout the regulatory text, we updated addresses for the Coast Guard Marine Safety Center, also adding in an email address option. We updated cross-references where necessary, and made changes to remove passive tense from the requirements. These changes improve the readability of the regulation, and clarify requirements.

We made a number of non-substantive changes to the approval procedures found in 46 CFR subpart 162.060. Like many of the changes we are making, these changes improve the readability of the regulation, and clarify requirements. We also revised the regulatory text that was proposed in 46 CFR 162.060-40. In the NPRM, that section included all requirements for ILs. In this final rule, we have split those requirements into two sections (46 CFR 162.060-40 and 162.060-42). The first section includes requirements for ILs applying for Coast Guard designation; the second section now contains the responsibilities imposed on ILs once they are designated by the Coast Guard.

These changes result in more easily understandable regulations, but do not make substantive changes. For this reason, the Coast Guard has determined that further notice and comment on the changes is unnecessary, pursuant to 5 U.S.C. 553(b).

B. Discussion of Comments

We received 662 comment letters on our NPRM, which contained 2,214 individual comments. We have divided our discussion of these comments into subject matter topics, and our responses are laid out in the following sections.

1. Applicability

One hundred and thirty four commenters addressed the applicability of the proposed regulations. Of these, 39 requested an exemption based on the segment of industry in which their vessel is engaged. These industry segments include: towing vessels and barges; offshore energy services support vessels; commercial fishing vessels; passenger vessels; offshore floating platforms; and vessels operating solely in the Great Lakes.

Many commenters generally criticized the application of the BWDS to their specific type of vessel. Forty eight commenters stated that various aspects of the design or operation of their vessels make it infeasible for them to practicably install a BWMS. The cited constraints include lack of space, lack of ballast piping, insufficient power available onboard, independent pumps and piping for each tank, insufficient BW holding times and pumping capacities in excess of current BWMS capabilities.

As we have discussed in this preamble, we have revised the applicability of this final rule so that the BWM requirements primarily apply to vessels with ballast tanks operating in waters of the United States after having operated outside of the EEZ (

see

V.B. Summary of Changes from the NPRM). Certain other vessels that operate exclusively in the EEZ and in more than one COTP Zone, and that meet certain size thresholds that make them similar to vessels operating on international routes are also required to comply. The Coast Guard, however, intends to expand this applicability in the near future after further study and will keep these commenters' requests in mind. We have also added, as discussed above, a provision for vessel owners who are required to comply with the BWDS but cannot do so for good reason (such as design and operating conditions or unavailability of systems) to request a delay in their compliance date.

Vessels Operating Solely in the Great Lakes

Twenty one commenters asked that vessels operating solely in the Great Lakes be treated differently from seagoing vessels due to the constraints cited above. Those commenters also requested that they be allowed to continue the best management practices currently in place instead of being required to install BWMS.

Conversely, 35 commenters urged the Coast Guard to regulate vessels operating solely in the Great Lakes. Five commenters asked the Coast Guard to hold vessels operating solely in the Great Lakes to the most stringent BWDS possible. One of these commenters submitted a petition with 8,905 individual signatures in support of stronger regulation of vessels that operate exclusively in the Great Lakes.

One commenter supported regulating vessels operating solely in the Great Lakes but felt the regulatory priority should be on preventing introductions of aquatic NIS by oceangoing vessels. Two commenters supported expanded regulation of vessels operating solely in the Great Lakes, but asked that the regulations take into account the unique design and operating characteristics of these vessels. Twenty seven additional commenters supported regulating this vessel population without providing a specific reason.

For the reasons we have discussed in this preamble, we are not requiring vessels that operate exclusively in the Great Lakes to comply with the BWDS in this final rule (

see

V.B. Summary of Changes from the NPRM). The Coast Guard intends to re-examine this decision in the near future, and will keep these commenters' requests in mind when developing subsequent rulemakings.

Municipal Water as Ballast

Twenty commenters urged the Coast Guard to exempt vessels from having to treat their ballast water if the water was obtained from a municipal water supply, as they believe this poses little risk of introducing or spreading NIS in

waters of the United States. The commenters stated that this is a common practice for inland towing vessels and/or barges, offshore energy services, and small business interests, and is authorized under existing Coast Guard policy.

Fifteen commenters proposed that vessels should be allowed to use municipal or potable water for ballast water. These commenters also proposed that vessels should be permitted to discharge that water into waters of the United States without having to use a Coast Guard-approved BWMS or to meet the BWDS.

The Coast Guard agrees that, in some situations, ballast water does not pose a significant threat of introducing or spreading NIS. We have some concerns about the variable quality of municipal water sources, but believe that water that satisfies the standards of the Safe Drinking Water Act (42 U.S.C. 300f-300j) should be acceptable for use as ballast water without posing a significant threat of introducing or spreading NIS. As a result, we have revised the regulation to allow for use of water from a U.S. public water system (PWS) meeting the requirements of the Safe Drinking Water Act as an alternative to installing a BWMS meeting the BWDS. We note, however, that with the exception of PWS water used under extraordinary circumstances in accordance with 33 CFR 151.1515, a vessel must exclusively use PWS water as ballast. Any mixture of water obtained from a source other than a facility meeting the requirements of the Safe Drinking Water Act will negate acceptability of water from a PWS as discharged ballast water. This change is found in 33 CFR 151.1510(a)(4) and 151.2025(a)(2).

COTP Zones

Seven commenters urged the Coast Guard to not grant regulatory exemptions for vessels operating exclusively in a single COTP Zone. They noted that these zones are not ecologically meaningful subdivisions and asked that any boundaries be based on scientific analysis of the risk of transferring invasive NIS.

Conversely, 17 commenters urged the Coast Guard to provide exemptions for vessels that operate exclusively in a single COTP Zone or conduct all ballast operations in a single COTP Zone. They argued that these practices would pose minimal environmental risk.

Four commenters requested a correction to the regulatory text to ensure that the proposed exemption for vessels operating exclusively in one COTP Zone (33 CFR 151.2015) extends to the BWM requirements (33 CFR 151.2025), consistent with the description of this provision in the preamble to the NPRM. One commenter called for the Coast Guard to continue to exclude vessels operating exclusively within one COTP Zone from the requirement to meet the BWDS.

For the reasons discussed earlier in this preamble, the BWM provisions of this final rule will not apply to vessels operating exclusively in a single COTP Zone (

see

V.A. Summary of Changes from the NPRM). The issue of whether there are distinct zones or areas other than COTP Zones where it might be appropriate to include an exemption for vessels that do not leave that zone or area remains open to consideration. The Coast Guard will investigate other possible ways to craft a geographic exemption, using suggestions from commenters and our Federal agency partners. The Coast Guard has determined that, for now, this is the best applicability delineation for the regulation based upon the available information and the Coast Guard's needs in effectively administering the ballast water program. The Coast Guard intends to re-examine this decision in the near future, and we will keep these commenters' requests in mind as we develop subsequent rules.

This rulemaking project has highlighted the need for additional research and analysis for ballast water regulatory efforts. A primary source of data for this research and analysis is the Ballast Water Reporting Form (available on the NBIC Web site at

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

), which vessels operating exclusively within a single COTP Zone are currently exempted from completing. In the future, the Coast Guard may initiate a separate rulemaking to expand the number of vessels submitting ballast water reports so that we can meet the statutory requirements for maintaining a clearinghouse on national ballast water data, and to collect additional data for use both in future regulations, and in future practicability reviews.

Great Lakes and Gulf of Mexico Ecosystems

Twenty two commenters urged the Coast Guard to designate the waters of the Ninth Coast Guard District as a single COTP Zone and exempt vessels operating exclusively in that zone from BWM requirements. In support of this position, the commenters noted that a ballast water bill passed by the U.S. House of Representatives in 2008 determined that the Great Lakes were an “enclosed aquatic ecosystem” and exempted vessels that confine their operations to those waters from installing BWMS.

Ten commenters suggested that vessels operating exclusively in the Gulf of Mexico be exempt from BWM requirements. In support of this position, the commenters noted a high level of connectedness between different areas of the Gulf of Mexico and the fact that the National Oceanic and Atmospheric Administration considers the Gulf of Mexico to be a single “Large Marine Ecosystem” based on ecological criteria.

The Coast Guard acknowledges the issues raised in these comments and will continue to work with the scientific community and regulatory agencies to investigate the bases for establishing more ecologically meaningful geographic zones for regulating ballast water operations.

Other Applicability

Two commenters urged the Coast Guard to consider the use of land-based or vessel/barge-based reception/treatment facilities. The Coast Guard agrees that use of shore-based or barge-based treatment might become a valid option for some vessels and has provided for this in the final rule. We have done so by revising the language in the regulations to make it clear that the BWDS only applies to those vessels falling within the rule's applicability thresholds (vessels that also discharge ballast water into waters of the United States). Those vessels discharging to land-based or vessel/barge-based reception/treatment facilities would not fall within this defined group, and therefore would not be required to install a BWMS that meets the BWDS. Any reception/treatment facilities used under this option would be subject to applicable state and local laws, as well as NPDES permitting if the treated water is discharged to waters of U.S.

Four commenters requested that the Coast Guard exempt any vessel that does not discharge ballast water in waters of the United States. Three additional commenters argued that vessels not discharging ballast water into the waters of the United States should not be subject to the requirement to install BWMS.

It was never the intention of the Coast Guard to require vessels to install a BWMS if they do not discharge ballast water into waters of the United States. We have clarified in this final rule that vessels not discharging ballast water into the waters of the United States are not required to install a BWMS. However, unless exempted, vessels are still required to report their BWM

practices on their Ballast Water Reporting Form.

One commenter suggested that applicability be based on a vessel's ballast water capacity. The Coast Guard notes that applicability of the rule is based, in part, on vessel ballast water capacity. While the discharge standard does not vary by vessel type, the dates at which vessels must meet the ballast water discharge standard if using a BWMS are based on vessel ballast water capacity.

As we move forward with expanding the applicability of this rule, however, we will continue to consider multiple factors, including ballast water capacity.

One commenter recommended exempting offshore floating platforms from the regulations, as these facilities rarely move. The Coast Guard does not believe that a categorical exemption is warranted. Under this final rule, an offshore floating platform would be exempted as long as it conducts ballast operations exclusively within a single COTP Zone. Additionally, we believe there are operational practices (e.g., offload to a reception vessel) that will allow an offshore floating platform to comply with the BWM regulations without having to install a BWMS.

One commenter suggested exempting reduced operating status (ROS) vessels that spend the majority of their time in layup or reduced crew status and are activated for short times (Maritime Administration Ready Reserve or Military Sealift Command vessels). The Coast Guard believes that if a vessel is not operating, it should not be discharging ballast water and there would be no requirements to meet when in ROS. In addition, in the event an ROS vessel meets the definition of a vessel of the Armed Forces under Section 312 of the Federal Water Pollution Control Act (33 U.S.C. 1322), it would be exempt from this final rule by section 151.2015(a)(191).

One commenter asked that exemptions and exceptions in the rule be consistent with the IMO BWM Convention. The Coast Guard believes that the commenter was referring to exemptions to the requirement to meet a BWDS that nation states could grant under the IMO BWM Convention once it enters into force. It is the Coast Guard's position that all vessels should take all practicable measures to ensure NIS are not discharged into the waters of the United States from vessels through ballast water; however, we note that we have included exemptions and exceptions in this final rule that are consistent with both our statutory mandate under NANPCA, as amended by NISA, and international law, including but not limited to the IMO BWM Convention (which has not yet entered into force). We will continue to develop our regulations and work with other countries to protect our environment.

2. BWDS

General Concern

Eighteen commenters submitted general concerns on the BWDS. Seven commenters stated their general opposition to the NPRM and three commenters stated their general support. Two commenters believed there was insufficient scientific and technical support in the record for the proposed regulation.

Four commenters stated that the BWDS and implementation schedule must be protective of the Great Lakes and one commenter expressed this concern for all waters of the United States. One commenter requested that the final regulations reflect reasonable and balanced programs that harmonize the commercial importance and environmental value of the Great Lakes.

The Coast Guard acknowledges these general concerns. Many of these concerns are echoed in more specific comments that we received, and those are summarized and addressed previously in this preamble and in the text that follows.

Support Concept

Twelve commenters supported the concept of a numeric, concentration-based BWDS, and three commenters said that such a BWDS will create the necessary market conditions to encourage investment in and development of technologies capable of achieving the objective of this rule. The Coast Guard agrees with these comments, and believes that setting a numeric, concentration-based BWDS in this final rule is the best approach to reducing the threat of the introduction and spread of NIS into the waters of the United States.

Stringency of Standard

One commenter supported the idea of a U.S. BWDS that at least meets the IMO BWM Convention Regulation D-2 discharge standard (IMO discharge standard) and any subsequent standard improvements. Another commenter stated that although they support the development of a BWDS like the phase-two standard, they also believe that starting with the achievable, measurable, and protective phase-one standard poses a much lower risk to the environment than starting with a stricter standard that is unachievable and immeasurable.

Six commenters supported establishing a discharge standard that is more stringent than the proposed phase-one standard, two of which also said the implementation schedule would not be protective as quickly as needed. Six commenters supported the proposed phase-two standard that is equivalent to the most stringent State standards, currently 1,000 times more stringent than the IMO discharge standard. One commenter said that the standard should be alternative 5 of the Draft Programmatic Environmental Impact Statement (DPEIS), which is essentially sterilization of ballast water.

One commenter stated that they did not support the adoption of a standard more stringent than the IMO discharge standard due to the impracticability of performing the necessary measurements to approve BWMS and test compliance.

One commenter stated that no technology developers with whom they have discussed treatment efficacy have been willing to provide assurances that their BWMS could reliably meet the phase-two standard, which is 1,000 times more stringent than the IMO discharge standard. This commenter further disagreed with the California State Lands Commission's (CSLC) conclusion that several BWMS have demonstrated the potential to comply with California's performance standards for the discharge of ballast water, and called for the Federal Government to perform its own analysis when conducting the practicability review prior to full implementation of the phase-two standard.

One commenter noted that the Great Lakes are a drinking water source and an irreplaceable freshwater natural resource. This commenter stressed the importance of implementing strong environmental regulations to protect such waters from the introduction of new NIS as well as from the establishment of new populations of NIS that currently exist within these waters.

Two commenters noted what they termed a lack of sufficient scientific and technical support in the record for the proposed regulation.

As we have noted in this preamble, this final rule is implementing the phase-one standard, which is equivalent to the IMO discharge standard, and deferring action on the phase-two standard until we can complete more analyses and research into practicability (

see

V.A. Summary of Changes from the NPRM).

The EPA SAB study (EPA SAB 2010), issued after publication of the NPRM for this rulemaking, provides support for our conclusion that technology to

achieve the IMO discharge standard represents the limit of current practicability. The SAB found that “* * * five of 34 categories of assessed BWMS achieved reductions in organism concentrations sufficient to comply with the first standard proposed by the USCG (i.e., the `Phase 1' standard).” Further, the SAB also concluded that “ * * * current test methods and detection limits preclude a complete statistical assessment of whether a BWMS meets any standard more stringent than Phase 1” (U.S. EPA SAB, 2011). We agree with the commenter who stated that implementing a less stringent, attainable standard that provides at least as much protection as BWE as soon as possible provides more protection than establishing a stricter standard and continually postponing it or deferring enforcement until it is achievable. We note the findings and recommendations of the National Research Council's (NRC) Committee on Assessing Numeric Limits for Living Organisms, which concluded that “The current state of science does not allow a quantitative evaluation of the relative merits of various discharge standards in terms of invasion probability.” The Committee further recommended that “(a)s a logical first step, a benchmark discharge standard should be established that clearly reduces concentrations of coastal organisms below current levels resulting from ballast water exchange (such as the IMO D-2 standard).”

While the Coast Guard agrees that it is necessary to have a protective standard in place as quickly as possible, we have delayed the initial implementation dates for newly constructed vessels to allow for the implementation of the U.S. type-approval process. The Coast Guard does not believe that it is possible to implement this process any faster, and that such a deferral is inevitable.

The Coast Guard disagrees with the commenters who stated there was an insufficient record for the NPRM as a whole. While we have already acknowledged that more analysis on the impacts of the phase-two standard should be completed, both the economic and environmental analyses that accompanied the NPRM contained information that, when combined with our discussion of the proposed rule in the NPRM preamble, provided reasonable justification for the NPRM.

Zero Discharge

Fifteen commenters advocated for the establishment of a zero-discharge standard, and said there should be no living organisms allowed in ships' ballast water. Four commenters said that NISA requires the Coast Guard to establish such a zero-discharge standard.

Conversely, three commenters opposed setting a zero-discharge standard, which they claimed would be operationally and practically unachievable. One commenter stated that the current knowledge of invasion biology seems to be insufficient to define no-risk discharge criteria.

Two commenters stated that the long-term goal should be zero discharge of live organisms.

The Coast Guard disagrees that NISA requires a zero-discharge standard. NISA requires the Coast Guard to develop regulations that prevent the introduction and spread of NIS to the maximum extent practicable, and we have no data that support setting a zero-discharge standard as being practicable. However, the Coast Guard is committed to implementing the most stringent BWDS that can practicably be achieved. As evidence of this, the Coast Guard has already indicated in this preamble that in a subsequent publication, after additional analysis and research, we intend to finalize the proposed phase-two standard or any standard higher than phase-one, as well as the recurring practicability reviews that were included in the NPRM, with the goal of determining and achieving the most protective BWDS practicable (

see

V.A. Summary of Changes From the NPRM).

Phase-One Standard

Fourteen commenters stated their support for the phase-one standard that is equivalent to the IMO discharge standard. One commenter requested that the phase-one standard become the permanent standard for the United States.

The Coast Guard agrees with the commenters who supported the phase-one standard, as we believe this standard is practicable, achievable, and provides a level of protection that is at least as effective as BWE. However, the Coast Guard also believes that future work, such as that suggested by the EPA SAB (EPA SAB 2011) and the NRC Committee (NAS 2011), may result in a better understanding of the need for more stringent standards and the development of improved technologies for treating ballast water on vessels, and will continue to work toward improving protective requirements in accordance with the directions and authorities in NANPCA 90.

Thirteen commenters opposed the phase-one standard on the grounds that it was not sufficiently protective. One commenter proposed that the phase-one standard be set at 10 times more stringent than the IMO discharge standard, 5 commenters proposed that the phase-one standard be set at 100 times more stringent than the IMO discharge standard, and 4 commenters proposed that the phase-one standard be set at 1,000 times more stringent than the IMO discharge standard, which would be the equivalent of the proposed phase-two standard.

One commenter suggested dropping the phase-one standard and immediately undertaking a practicability review of the phase-two standard, which the commenter believed would result in an indefinite deferral of the phase-two standard as non-practicable. One commenter opposed the phase-one standard proposed in the NPRM without giving specific reasons.

The Coast Guard has found, based on the best scientific information available to the Coast Guard (including the previously referenced EPA SAB study on technologies and systems to minimize the impacts of invasive species in vessel ballast water discharge (EPA SAB 2011)), that there are currently no BWMS that have demonstrated the capability to meet a standard more stringent than the phase-one standard. Additionally, there are no available, standardized testing protocols that can be used to demonstrate that a BWMS can meet a standard 100 or 1,000 times more stringent than the phase-one standard.

Implementing both the phase-one and a more stringent but unachievable standard in a single rulemaking would result in foregoing the near-term protection this rulemaking provides. The Coast Guard believes ensuring this near-term protection now is in line with our statutory mandate from NANPCA, as amended by NISA. As we explained in this preamble, we are not abandoning the phase-two standard (

see

V.A. Summary of Changes from the NPRM). We are committed to implementing a standard that provides the most protection that can practicably be achieved.

One commenter opposed the phase-one standard on the grounds that it would be difficult to assess and therefore enforce. The Coast Guard disagrees. The EPA has already issued its ETV Protocol, which is incorporated by reference into this final rule and will be used to assess a BWMS' success in meeting the BWDS. The Coast Guard's type-approval process provides a strong means of verifying whether a BWMS can likely achieve the BWDS when installed and operating. Finally, Coast Guard port-state control officers will provide the final enforcement check to

ensure that a BWMS is operating as it should to meet the BWDS.

One commenter requested a modification to the phase-one standard to account for organisms less than 10 micrometers in size. The Coast Guard disagrees that this is necessary for the phase-one standard, as the IMO discharge standard did not include this size category. We may consider additional size categories for the phase-two standard.

Two commenters requested that the phase-one standard be aligned with the IMO discharge standard and other provisions of the IMO BWM Convention. The Coast Guard believes that we have made the phase-one standard as consistent as possible with the IMO discharge standard. We have made a slight adjustment in our implementation schedule to allow for practical realities involved in implementing a U.S. type-approval program, but we have also included a provision to allow for BWMS that have been approved by foreign administrations under the IMO BWM Convention to be accepted on an interim basis (

see

discussion in V.A. Summary of Changes from the NPRM).

Phase-Two Standard

Thirteen commenters supported the phase-two standard as proposed in the NPRM. One commenter stated that vessels would benefit by having to install a BWMS only once at a potentially more protective standard. One commented that adopting the phase-two standard would encourage manufacturers to modify existing BWMS components and develop new technologies that could meet multiple stringency standards.

Conversely, 47 commenters opposed the phase-two standard as being counterproductive on the grounds that there are no accepted test protocols or BWMS that have been proven to meet any limits more stringent than phase-one. Two commenters opposed the phase-two standard because BWMS manufacturers have focused their research, development, and certification efforts on the IMO discharge standard, and may not have the resources to start over.

One commenter requested that a size category for organisms less than 10 micrometers be added to the phase-two standard. Two commenters requested removing the phase-two standard for viruses due to the impracticability of treating for viruses and the difficulty of testing virus viability. One commenter stated there are no technologies, scientific methods, or protocols to differentiate between active versus inactive virus-like particles, which would make it impossible to measure the efficacy of BWMS in achieving the proposed phase-two standard for viruses.

Two commenters said that the phase-two standard should only allow for use of less stringent standards under temporary special exemption cases (e.g., vessel types or discharge characteristics) as determined by a technology review. One commenter suggested an interim measure like Michigan's BWM regulation, which identified specific treatment processes. The commenter believed that such an approach could be implemented across the Great Lakes more quickly than the proposed standards.

Three commenters stated that the phase-two standard should be delayed until instrumentation and methods are available to measure the capability of BWMS to meet the standard. One commenter stated that the phase-two standard is unnecessarily stringent for vessels that operate in the Great Lakes. One commenter stated that the phase-two standard should not have a defined value before the results of the practicability review are known.

One commenter opposed the phase-two standard for vessels that operate solely on the Great Lakes, arguing that the large volumes of treated water being discharged would essentially distill the Great Lakes of essential organisms necessary for aquatic health.

One commenter stated that one BWMS could meet multiple stringency standards by adjustment of its operational parameters, although this may depend on the treatment methodology of a particular system.

One commenter recommended that phase-two technologies should be based on conversions of the existing phase-one platforms.

As we have discussed in this preamble, this final rule only contains implementation requirements for the phase-one standard (

see

V.A. Summary of Changes from the NPRM). We are taking all of the comments we received on the phase-two standard into consideration as we begin the process of completing economic and environmental analyses for the phase-two standard, and will continue to consider these comments as we draft a notice or other rulemaking document addressing the phase-two standard.

Grandfather Period

Seven commenters opposed any grandfather period. Two of these commenters argued that vessels that install a phase-one system should not be exempt from the phase-two standard. One of these commenters requested that best available technology be required at all times, which would eliminate the use of a grandfather period.

One commenter stated that the grandfather period should be decreased from 5 to 3 years, whereas two commenters argued that 5 years was an appropriate grandfather period.

Fifteen commenters stated that 5 years was not long enough for a grandfather period. Twelve commenters stated that an installed BWMS should be grandfathered for the useful life of the vessel, and 10 commenters stated that BWMS should be grandfathered for the effective life of the system. Fourteen commenters stated that an installed BWMS should be grandfathered for the life of either the vessel or BWMS, whichever ends first.

One commenter stated that the grandfather period should be increased from 5 years to 10 years or the lifetime of the vessel, one commenter stated that it should be increased to 15 years, two commenters stated that it should be increased to 15 years or the life of the vessel, and one commenter stated that vessels should be given a specific date by which to upgrade once a phase-two standard is established.

As discussed in this preamble in V.A. Summary of Changes from the NPRM, the Coast Guard is not including the phase-two standard in this final rule. Because the final rule only includes the phase-one standard, we have omitted the grandfather provision that we proposed in the NPRM. We expect to reconsider the grandfather provision when we address the proposed phase-two standard or any standard higher than phase-one in a notice or other rulemaking document. We will keep these comments in mind as we develop that proposal.

Practicability Review

Thirty nine commenters supported a practicability review that is sufficiently robust and comprehensive to determine whether a BWDS more stringent than the phase-one standard is achievable. One of these commenters said that the review should be limited to the testing and certification requirements of the IMO BWM convention and guidelines. Six commenters recommended that the practicability review ensure that any phase-two standard is effective, measurable, technologically feasible, commercially available, safe, and cost-effective for use with the characteristics of the vessel.

One commenter said the regulation should contain an express statement that the Coast Guard will not make upward revisions of the treatment

standard unless it is economically reasonable to do so, and that we should include criteria for that determination. Another commenter said that if and when a BWMS can achieve the phase-two standard of 1,000 times more stringent than the IMO discharge standard, no further practicability reviews should be conducted with regard to achieving even higher standards.

Ten commenters said that a practicability review should be conducted for the phase-one standard as well. Twenty three commenters said that the reviews must verify there are BWMS that are suited to the volumes, flow rates, and engine room specifications of Great Lakes vessels before imposing the phase-one standard on these vessels.

Six commenters agreed with the proposed 3-year cycle for practicability reviews, seven recommended that the reviews be conducted on a continuous basis, three recommended that the reviews be conducted every year, one suggested a 3- to 5-year cycle, and three recommended a 5-year cycle.

Six commenters wanted a firm deadline for practicability reviews. Six others stated that the timing and scope should be accelerated from 2010 to 2012 to inform both the phase-two standard and the 2013 renewal of the EPA VGP.

Conversely, 19 commenters opposed any practicability review that could indefinitely delay implementation of the final standard, calling it a “loophole.” Eight of these commenters requested an electronic docket and public comment period before any final determinations based on practicability reviews are made. One commenter stated that moving the practicability review would not allow time for vessels with a 2014 compliance date to implement technology that meets the phase-two standard. Two commenters said there is no evidence presented in the NPRM or DPEIS to justify claims that the phase-two standard is not currently achievable, and therefore the practicability review is not necessary.

Three commenters requested a definition for “practicability” and for the inclusion of specific content and format of the review. One commenter said the rule should place an upper limit on how long the implementation date can be extended at any given time. One commenter stated that there should be a practicability review for vessels based on the type of vessel and the geographic route(s) it serves, (i.e., ocean-going service, inland waters, Great Lakes, near coastal, etc.).

As discussed in this preamble in V.A. Summary of Changes from the NPRM, because we have removed the phase-two standard from this final rule, we have also removed the recurring practicability reviews that were included in the NPRM. We expect that regular assessments, per NISA's “[p]eriodic review and revision” provisions, codified at 16 U.S.C. 4711(e), will be part of any future rulemaking process. This will address the scenario in which a finalized phase-two standard either cannot be implemented according to the established timelines, or can be implemented more quickly than the established timeline.

There is one practicability review provision included in this final rule that requires the Coast Guard to complete and publically publish the results of a practicability review no later than January 1, 2016. This review will draw a significant component of its information from the type-approval application packages that the Coast Guard expects to evaluate between this final rule's publication date and the initial implementation date. Further, the findings and recommendations of the EPA SAB study (EPA SAB 2011) will usefully inform the development of the practicability review. The Coast Guard will look at a variety of factors, including but not limited to the efficacy and environmental safety of available technology, and economic factors. While we have listed a number of these factors in the rule, there is a provision allowing for consideration of additional factors. We included this provision because of the possibility that the Coast Guard may discover additional factors that would be relevant to a decision on whether or not it is practicable to increase the stringency of the BWDS.

These changes address some of the comments summarized previously. We will continue to keep comments related to the recurring practicability reviews in mind as we develop a notice or other rulemaking document implementing the phase-two standard. While we have not included a practicability review prior to the implementation of the phase-one standard, we have included a provision to allow vessel owners and operators to request an extension of their compliance date if they cannot practicably comply with the compliance date otherwise applicable to their vessel. Summary information concerning all extension decisions, including the name of the vessel and vessel owner, the term of the extension, and the basis for the extension will be promptly posted on the U.S. Coast Guard Maritime Information Exchange Web site (CGMIX), currently located at [

http://cgmix.uscg.mil/Default.aspx

].

Implementation Schedule

One commenter was opposed to extending the phase-two deadline unless a future public comment period establishes that such an extension is necessary to allow for practicable implementation of the phase-two standard. Four commenters agreed with the proposed schedule for implementation of both the phase-one and the phase-two standards.

Eighty one commenters requested that the implementation schedule be changed in some way. Eleven commenters stated that a BWDS should take effect immediately, and one commenter said it should be implemented in 1 year. One commenter said the phase-two standard should take effect immediately, while another said that 3 to 5 years is plenty of time. Three commenters stated that the phase-two standard should take effect by 2012 and one said it should take effect by 2016. Three commenters opposed reliance on drydocking schedules in favor of hard deadlines for compliance, unless justified by vessel-specific engineering constraints or lack of availability.

One commenter stated that existing vessels should be required to schedule their first drydocking by 2012, and to comply with the phase-one standard by 2014 unless the practicability review deems that deadline unattainable. One commenter suggested installation at the first dry dock after 2014. Two others suggested that a more appropriate timeline for all new and existing vessels would be 2012 or 2014, respectively.

Thirty three commenters said that the phase-one standard should be implemented by 2012 and the phase-two standard by 2016. Another commenter agreed with this schedule but with a more stringent phase-one standard. One commenter supported a phase-one standard 100 times more stringent than the Coast Guard's proposal by 2012 and a phase-two standard 1,000 times more stringent than phase one by 2016.

Two commenters considered the schedule for implementation of the proposed regulations to be too protracted, and called for implementation of the phase-two standard at an earlier date than proposed. These organizations did not support allowing shipowners so much time between the implementation date and their first scheduled drydock.

Conversely, 26 commenters requested that the implementation schedule be lengthened or allow more flexibility for vessel types or specific geographic areas. Thirteen commenters said that the dates should be delayed until

compatible BWMS are commercially available for their vessels and to accommodate standard drydocking cycles of twice in 5 years. One commenter said that vessels traveling to specific areas such as the Great Lakes could comply with the 2014 date, but did not think this was a realistic option to apply to vessels in all waters of the United States.

One commenter stated that the proposed schedule does not allow enough time for vendors to develop BWMS capable of meeting the phase-two standard, particularly since methods and facilities capable of testing to the phase-two standard will need to be available in order to develop such systems.

One commenter stated that vessels confined to the Great Lakes will not have sufficient shipyard availability to install equipment to meet the BWDS on the proposed schedule. Four commenters stated that some vessels operating in the Great Lakes have very short voyages (on the order of hours). If BWMS available for such vessels are limited to chemical systems with required minimum treatment times longer than the voyages, then significant delays will occur in the transportation chain. Two industry associations commented that the proposed schedule was not feasible due to a lack of available BWMS and a shortage of shipyard capacity for installation.

The Coast Guard considered these comments. First, to accommodate the implementation of the final rule in relation to delays encountered in the rulemaking process, the Coast Guard has revised the implementation schedule for the phase-one standard at 33 CFR 151.1512(b) and 151.2035(b) to provide new vessels the 2 years for implementation as presented in the 2009 proposed rule. Addressing concerns with the schedule more generally, while we agree with those commenters who would like to see a requirement that BWMS be installed on vessels as soon as possible, it is important to consider several factors that impact the timeline during which approved BWMS can be expected to be installed. These include the time required for the United States to implement a BWMS approval process, for manufacturers to establish production capacity, and for vessel owners to acquire and install BWMS within their vessels' normal operational and maintenance schedules. As a result, there will likely not be an adequate number of approved BWMS to allow for acceleration of the implementation schedule in the 2009 proposed rule. Phase-two and its implementation schedule are not addressed in this final rule. As discussed in the “Summary of Changes from the NPRM” section above, the Coast Guard will develop additional analyses regarding the potential costs, benefits, and environmental impacts of the proposed phase-two standard or any standard higher than phase-one and intends to address the issue in subsequent rulemaking document.

Language Clarification/Technical Change

One commenter requested that the proposed BWDS include language necessary for differentiation between living and nonliving organisms. Another said that the standard should allow for the presence of nonliving organisms since some treatment technologies act to kill living organisms without necessarily removing them from the ballast water.

The Coast Guard acknowledges that the proposed BWDS is slightly different in this respect from the IMO discharge standard, which uses the term “viable” instead of “living.” It is important to note that, while the text of the IMO BWM Convention refers to “viable” organisms, the G8 guidelines define “viable” as “living.” Therefore, the Coast Guard has decided that this issue is best addressed in the BWMS approval process, and will not alter the standard as suggested by these commenters. We note that the standard and approval process do allow for the presence of nonliving organisms. Additionally, we corrected a technical error present in the NPRM, which mistakenly omitted the term “living” from the proposed 33 CFR 151.1511(a). This final rule corrects that omission.

One commenter requested an addition to the BWM requirements in 33 CFR 151.2025(a)(1) that would read “(i) Unless 151.2040(b) allows otherwise, the BWMS must be used prior to any discharge of ballast water to waters of the U.S. (ii) All treatment must be conducted in accordance with the BWMS manufacturer's instructions and standard of performance approved by the Coast Guard.”

The Coast Guard disagrees that this addition is necessary. Vessel owners/operators must comply with the BWDS for all ballast water discharged following treatment with a BWMS, and follow the manufacturer's Operation, Maintenance, and Safety Manual to maintain their systems in proper working order.

One commenter asked that a definition be provided for “regular” and “regularly,” as those terms are used in 33 CFR 151.2050, which requires vessels owners or operators to clean their ballast tanks regularly to remove sediments and to remove fouling organisms from hull, piping, and tanks on a regular basis. The Coast Guard disagrees, and believes that there should be some flexibility to schedule these activities according to a vessel's specific circumstances.

One commenter believes that portions of 33 CFR 151.2050 (additional requirements) are intended to be discretionary rather than mandatory, and should be separate categories. The Coast Guard disagrees. The Coast Guard included the term “minimize or avoid” in 33 CFR 151.2050(b) to ensure that vessel owners and operators always consider these additional requirements, while allowing some flexibility according to a vessel's specific circumstances.

One commenter suggested adding a definition for “test report” at 46 CFR 162.060-3, as the term is used in multiple places. The Coast Guard disagrees, as the Test Report is described in 46 CFR 162.060-34.

One commenter suggested revising the proposed definition for “hazardous location” found in 46 CFR 162.060-3. The Coast Guard agrees and revised the definition.

One commenter suggested requiring contact information, in addition to manufacturer's name, in 46 CFR 162.060-10(a)(1). This commenter also suggested that the phrase “Name and type of BWMS” in 46 CFR 162.060-10(a)(3) be revised to also require the mode of action or other information. The Coast Guard partially agrees; we have added a requirement for point of contact information for the manufacturer to 46 CFR 162.060-10. However, we have not made the requested change to 46 CFR 162.060-10(a)(3), as we believe this is already reflected in the existing text.

One commenter asked that the phrase “novel processes” in 46 CFR 162.060-10(e) be defined. The Coast Guard disagrees, because it does not wish to preclude any innovative approaches in BWMS.

One commenter asked whether the IL or manufacturer is required to submit the Test Report to the Coast Guard Marine Safety Center (MSC) as part of the approval process. The Coast Guard approval process places responsibility on the manufacturer to submit all necessary materials to the MSC, however, it is acceptable if the IL submits the report directly to the MSC.

One commenter was unsure what types of approvals are required under 46 CFR 162.060-14(a)(7), such as those from U.S. agencies, foreign administrations, classification societies,

and other organizations. The Coast Guard's response is that 46 CFR 162.060-14(a)(7) pertains to approval of BWMS using active substances, and that manufacturers are responsible for obtaining all required approvals external to the Coast Guard's approval process. We anticipate issuing guidance documents to aid manufacturers in complying with the approval process.

One commenter noted what appeared to be conflicting information as to exactly which vessels this rule would apply to and whether all vessels would be required to install BWMS. The Coast Guard responds that these are separate but related questions. First, 33 CFR 151.1502 in the existing regulations and 33 CFR 151.2010 (Applicability) of this final rule describe which vessels will be required to comply with 33 CFR part 151 subparts C and D, or subsections of them. This is a broad description, as many vessels not required to install a BWMS will need to comply with other requirements in 33 CFR part 151 subpart D, such as recordkeeping requirements. Several groups of vessels are exempted from BWM requirements under § 151.2015.

Secondly, 33 CFR 151.2025 (BWM requirements) of the final rule identifies which vessels must install a BWMS that complies with the BWDS, or manage their ballast water in another one of the methods listed in that section.

One commenter requested clarification of the requirement “Records any bypass of the BWMS” at 46 CFR 162.060-20(b)(5). The commenter noted that not all BWMS will be able to do this, as some bypasses may be achievable using systems or components that are outside of the BWMS. The Coast Guard agrees and has removed this provision.

Management Requirements

Two commenters suggested that the practicability of on-shore or vessel/barge-based ballast water treatment be explored. The Coast Guard encourages the development of alternative treatment methods that would allow some vessels to manage their ballast water without having to install a BWMS. The phase-one standard in this final rule will only apply to vessels that discharge ballast water into waters of the United States. Vessel owner/operators discharging ballast water to a facility onshore or to another vessel must ensure that all vessel piping and supporting infrastructure up to the last manifold or valve immediately before the dock manifold connection of the receiving facility or similar appurtenance on a reception vessel prevents untreated ballast water from being discharged into waters of the U.S.

Once Ballast water is pumped to an on shore treatment facility or a treatment vessel it would not be subject to 33 CFR part 151 subpart C or D. However, under the CWA any resulting discharges from these on-shore treatment facilities or treatment vessels are subject to the National Pollutant Discharge Elimination System (NPDES) program. Companies that intend to provide these services will be responsible for complying with these and other local, state, and Federal laws and regulations.

One commenter suggested requiring BWMS in addition to, rather than instead of, existing BWE requirements for ocean going vessels entering the Great Lakes-St. Lawrence Seaway system. The Coast Guard disagrees. Requiring both BWE and BWMS for oceangoing vessels entering the Great Lakes was not proposed in the NPRM and therefore beyond the scope of this rulemaking.

One commenter stated that the allowance of BWE under the phase-one standard is inconsistent with the goal of minimizing NIS introductions and should be eliminated as an option. The Coast Guard agrees that BWE should be eliminated as an option as soon as possible. The primary purpose of NANPCA, as amended by NISA, is to “prevent the unintentional introduction and dispersal of nonindigenous species into waters of the United States through ballast water management and other requirements.” 16 U.S.C. 4701(b). Permitting BWE to remain as a permissible management technique in light of other, more protective methods, would frustrate this clearly articulated statutory purpose and lead to an absurd result.

See Griffin

v.

Oceanic Contractors, Inc.,

458 U.S. 564, 575, 102 S.Ct. 3245 (1982) (statutory interpretations “which would produce absurd results are to be avoided if alternative interpretations consistent with the legislative purpose are available.”) The Coast Guard is thus phasing out BWE as a BWM method in favor of more protective methods to best prevent the introduction and spread of NIS into waters of the U.S. consistent with this statutory purpose.

We also believe that existing vessels should be given a reasonable period of time to come into compliance with the phase-one standard, and that BWE should continue as a viable BWM alternative for a vessel until the phase-one standard applies to that vessel. However, we note that once a vessel is required to comply with the phase-one standard, BWE will no longer be an acceptable routine management method.

One commenter noted the U.S. Administration's goal of expanding coastwise or short-sea shipping, and requested that BWE be added as a management option for these vessels. The Coast Guard notes that its existing regulations do not require coastwise vessels to conduct BWE unless their voyage takes them more than 200 nautical miles from any shore. For the final rule, we have revised 33 CFR 151.2015 to exempt certain vessels from the BWM requirements and 33 CFR 151.2025 to provide additional BWM options besides installing BWMS. These changes are discussed above under the heading “Applicability.”

One commenter suggested retaining BWE for all vessels when practicable, requiring a combination of best available technology and BWE to improve BWMS performance, and requiring BWE as a minimal treatment in case the BWMS fails. Another suggested the addition of rules requiring BWE 50 nautical miles outside the continental baseline for vessels conducting coastal voyages, implementation of a BWE verification system, and allowance of BWE within 200 nautical miles when a safety exemption would otherwise allow un-exchanged water to be discharged at a State port. The Coast Guard disagrees, and believes that phasing out BWE in favor of the BWM requirements in this final rule will be at least as effective as BWE to prevent the introduction of NIS into the waters of the United States. The Coast Guard notes that under 33 CFR 151.2040(b), the COTP may allow the vessel to conduct BWE as a management option if the BWMS fails to operate or the vessel's BWM method is unexpectedly unavailable.

Preamble Text

One commenter disagreed with the statement in the NPRM that “The effectiveness of BWE is highly variable, largely depending on the specific vessel and voyage” (74 FR 44663). The commenter added that the Great Lakes Seaway Ballast Water Working Group's strict enforcement of BWE requirements in the St. Lawrence Seaway is the main reason that there have been no reports of the establishment of invasive species on the Great Lakes since 2006.

The Coast Guard acknowledges the bi-national success in achieving high rates of regulatory compliance with existing BWE requirements. However, we do not have evidence that this successful enforcement necessarily proves the effectiveness of BWE, as there are also other regulations and requirements

being enforced for vessels entering the St. Lawrence Seaway.

Enforcement

Seventeen submitters commented on how the Coast Guard intends to enforce the BWDS.

Three commenters said there should be significant financial penalties to provide incentives for industry to meet implementation deadlines. The Coast Guard notes that the existing civil and criminal penalties for 33 CFR part 151 subparts C and D are established by statute and were not changed in the NPRM. They may now be found at 33 CFR 151.2080 of the final rule. After publication of the NPRM, in a separate action, the Coast Guard made an adjustment to the civil penalty tables found at 33 CFR 27.3. (75 FR 36273, 36278 (June 25, 2010)).

Five commenters stated that the numeric discharge standard would impose significant problems for compliance enforcement, particularly when results need to be legally acceptable, because sufficient techniques or equipment are not currently available to test ballast water on the spot. The Coast Guard disagrees, and believes that setting a practicable, numeric BWDS such as this final rule's BWDS, combined with type approval of BWMS, will facilitate compliance enforcement.

Another commenter said that a phase-two standard 1,000 times more stringent than the phase-one standard will be virtually impossible to enforce, and will significantly increase enforcement costs, and possibly increase downtime for inspected vessels. The Coast Guard agrees that implementation of the phase-two standard at this time could be impracticable for several reasons, including enforcement, as suggested by the commenter.

Two commenters requested that a rigorous enforcement, inspection, and monitoring program be developed to determine compliance, similar to that currently being performed by the bi-national Great Lakes Seaway Ballast Water Working Group for all vessels entering the St. Lawrence Seaway. Three commenters requested routine or random testing of the contents of a vessel's ballast tanks and ballast water discharge. One commenter said this testing would be especially important for oceangoing vessels that would discharge treated ballast water into freshwater. Two commenters suggested testing for total residual oxidants in ballast water as a way to determine the completion of chemical treatment, and installing onboard sensors in vessels' ballast tanks to measure chemical levels.

Four commenters asked about port state control requirements. One commenter requested that a limit of once in any calendar year must be imposed on the number of times that a vessel can be tested to determine whether its BWMS is working properly, and that onboard sensor data or the captain's signed and sworn certification transmitted to the port state authority should be sufficient. Another commenter said that vessel-based BWMS would not enable the port state authority to monitor ballast water. Two commenters stated that proper and effective sampling and test protocols, as well as required facilities and proficiency, still need to be established. One commenter requested specific information indicating how the BWDS will be enforced after implementation.

The Coast Guard believes that the approval process for BWMS, found in 46 CFR part 162.060 of this final rule, will provide a strong basis from which enforcement actions can proceed based on review of the records required to be kept on the vessel. These reviews will occur during port and flag state control exams. We acknowledge that compliance exam procedures for BWMS will be an important component of enforcement, and such procedures are under development. As discussed in the Summary of Changes section above, we have added a provision requiring sampling ports in order to facilitate enforcement of the BWDS.

Reporting and Recordkeeping

One commenter requested that the Ballast Water Reporting Form and reporting and recordkeeping requirements be revised to accommodate all of the proposed BWM methods in advance of the phase-one standard taking effect. The Coast Guard agrees, and will propose revisions to the Ballast Water Reporting Form and instructions either through a separate rulemaking project or in conjunction with the next scheduled renewal of the collection by OMB.

One commenter said the NBIC should be given regular dates for reporting information that they obtain from submitted reports. The Coast Guard notes that the NBIC already provides database information to the public through its Web site. As more vessels use electronic reporting, the NBIC is reducing delays in updating that Web site.

3. BWMS

General

Two commenters addressed the safety exception in 33 CFR 151.2045. The first commenter recommended that “vessel design limitations” should not be considered an “extraordinary condition” under which a master or person in charge of a vessel would be exempt from the requirement to use a BWM practice, including BWE, under certain circumstances. The second commenter supported the inclusion of the exception and interpreted it as allowing the discharge of ballast water that fails to meet the BWDS under emergency circumstances.

The Coast Guard believes that they may have misunderstood this provision. Under NISA, masters or persons in charge of vessels are not required to conduct BWE if the practice would be unsafe due to weather or vessel design. 16 U.S.C. 4701(k)(1). We have included this provision in the regulation, and it is an allowable exception to BWE only as long as a vessel is allowed to use BWE. Additionally, we have removed proposed 33 CFR 151.2045 Safety exceptions, as we determined that it was largely repetitive to what was proposed in 33 CFR 151.2040 Discharge of ballast water in extraordinary circumstances. We moved the one non-repetitive provision to § 151.2040. As a result, § 151.2040 now includes the provision noting that nothing in the regulations relieves the master, owner, agent, or person in charge of the vessel from any responsibility, including the safety and stability of the vessel and the safety of the crew and passengers.

Once a vessel is required to meet the BWDS, the general safety provision in § 151.2040 no longer applies. If the master or person in charge of the vessel determines that operation of the BWMS would endanger the vessel for some reason, the master or person in charge must inform the COTP, prior to the vessel's arrival, that BWM has not been conducted due to safety reasons. The COTP will evaluate the situation and direct the vessel accordingly.

One commenter considered the BWMS design and construction requirements to be onerous and likely to result in systems being overly complicated and expensive. The commenter called for the Coast Guard to approve the use of very simple approaches, such as manually pouring additives into tanks. The Coast Guard disagrees, and believes that all BWMS must be carefully designed, constructed, and approved to protect the vessel, the crew and passengers, and the environment. With respect to the example, treatment of ballast water using chemicals designed to kill organisms has the potential to adversely affect the safety of the vessel, the crew and passengers, and the environment if

the chemicals and the manner of their use are not carefully evaluated in advance and controlled and managed during use of the system.

Seven commenters stated that there were serious constraints on the feasibility of installing BWMS that require electrical service on tank barges and tank ships. Several commenters cited Coast Guard regulations for electrical equipment as an impediment to such installation (46 CFR 111.105-31(1)). Likewise, six vessel owners asserted that safety and regulatory requirements prohibit the installation on tank barges of BWMS that use electricity.

The Coast Guard agrees that electrical requirements included in 46 CFR subpart 162.060 may make installation of BWMS more complicated on certain vessels. However, if these requirements make it impossible for a vessel owner to safely install a BWMS, they should qualify for an extension of the compliance date, per 33 CFR 151.1513 or 151.2036. An extension would provide additional time to determine how BWMS can be safely installed. An extension would postpone installation costs for affected vessels. Data is unavailable on the number of vessels that would require extensions. We have not estimated the quantitative impacts of extensions.

One commenter proposed that the Coast Guard should require best available technology and BWE as an interim measure if compliant BWMS are not available by the implementation dates. The Coast Guard disagrees that best available technology and BWE together should be considered the de facto acceptable method of compliance. The Coast Guard considers establishing a practicable and protective BWDS to be the best approach for preventing the introduction of NIS by the wide array of vessels that must discharge ballast water for safe operation.

The Coast Guard believes that BWMS meeting the phase-one BWDS will generally be available in time for vessel owners and operators to comply with the implementation schedule in this final rule. For those cases where this is not so, we have provided a provision in the regulation that allows a master, owner, operator, agent, or person in charge of a vessel to apply for an extension of the compliance date.

One commenter asserted that BWE is sufficiently protective in preventing introductions of invasive species. This commenter also suggested that BWE should be an acceptable method of BWM if a vessel can demonstrate through sampling and analysis that BWE can meet the BWDS. Two commenters asserted that BWE is sufficiently protective in preventing invasive species introductions to the Great Lakes. These commenters further suggested that BWE should be an acceptable method of BWM for vessels entering the Great Lakes.

The Coast Guard disagrees that BWE is sufficiently protective against introductions of invasive species. Vessels are not always able to conduct BWE. While BWE has undoubtedly reduced the risk of introductions compared to no BWM at all, the inherent variability in the efficacy of BWE among vessels and even within vessels argues for the consistent application of more effective BWM practices. Additionally, as vessels on coastwise voyages are not required to conduct BWE under Coast Guard regulations, a BWMS is also necessary to ensure the prevention of the spread, and not just the introduction, of NIS.

One commenter questioned whether BWMS will effectively remove all contaminants in ballast water and asserted that onboard treatment will not be a viable option until that is the case. The commenter suggested that, as an alternative, vessels could use multiple systems to address all contaminants. The Coast Guard appreciates the commenter's concerns, but disagrees that a BWMS required under this rule will have to remove all potential contaminants in ballast water. NANPCA, as amended by NISA, requires the Coast Guard to ensure, to the maximum extent practicable, introductions of NIS are not discharged into the waters of the United States from vessels, and does not pertain to vessel discharges outside of that threat. The statute also requires that certain methods of BWM used instead of BWE must be environmentally sound. By requiring such systems to meet applicable EPA requirements related to treatment chemicals and their disinfection by-products prior to discharge, the Coast Guard will help ensure that treatment of ballast water does not result in adverse environmental consequences. The issue of non-organism contaminants in ballast water is also addressed under the EPA VGP. By requiring BWMS to meet all applicable EPA requirements prior to type approval, the Coast Guard will help ensure that treatment of ballast water does not create adverse consequences.

One commenter questioned whether onboard treatment is the best approach, given that IMO approval of BWMS is proceeding slowly. The Coast Guard disagrees that the pace of BWMS type approval under the IMO BWM Convention is proceeding slowly. In fact, we note that foreign type-approved systems are available.

One commenter questioned whether onboard systems were the best approach for preventing the discharge of organisms and noted that, unless a vessel is fitted with a backup system, the failure of the onboard treatment system could result in the discharge of untreated ballast. The Coast Guard notes that the rule has been revised to clarify that vessel owners and operators have a range of options for BWM, including use of BWMS, retention onboard, discharge to a shoreside treatment facility, or use of a U.S. PWS meeting Safe Drinking Water Act standards. We also note that the regulation requires BWMS to signal an alert if there is a failure and for vessel owners to report failures of the BWMS to the COTP at their place of destination. In such a situation, the COTP may require the vessel to perform alternative BWM practices before allowing the discharge of the ballast water.

Active Substances or Chemicals

One commenter asserted that many currently available BWMS use chemicals, and that these BWMS may result in contamination of ballasted fish holds. The commenter further stated that the proposed regulation must include exemptions for this circumstance. The Coast Guard agrees that chemical contamination of ballasted fish holds may be a problem with the use of a chemically-based BWMS. However, the Coast Guard is aware of several systems that do not use chemicals, and believes that owners and operators of fishing vessels will have sufficient options for meeting the BWDS (e.g., ultraviolet/filtration). For those fishing vessels that cannot install a BWMS onboard, we have provided a provision in the regulation that allows a master, owner, operator, agent, or person in charge of a vessel to apply for an extension of the compliance date if they can document that, despite all efforts to meet the BWDS requirements, compliance by that deadline is not possible.

Three commenters called for clarification as to how the regulations proposed in the NPRM would prevent the discharge of harmful active substances resulting from the use of BWMS. The Coast Guard agrees that the use of chemicals such as biocides to treat ballast water creates the potential for unwanted discharges of such chemicals. All systems using chemicals must be registered by EPA under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), as applicable, prior to consideration by the Coast

Guard for type approval. Discharges from vessels with systems using non-pesticide chemicals (or pesticides that are generated solely by the use of a device onboard the same vessel as the ballast water to be treated) will be covered under the EPA VGP, which contains requirements to meet discharge limits established by EPA for residuals and by-products of chemicals used in ballast water treatment. All chemicals used in BWMS requiring FIFRA registration will be registered with EPA prior to applying for Coast Guard type-approval of the BWMS. One commenter encouraged the Coast Guard to allow treatment of ballast water with biocides to address specific species on specific routes within the Great Lakes as an alternative method of compliance. The Coast Guard appreciates this commenter's input, but disagrees with the proposed approach. The identification, with appropriate specificity, of the location and identity of every infestation within the Great Lakes is not feasible, nor is the identification of the appropriate biocide for each specific species. The Coast Guard has determined that the most protective approach is to require the uniform treatment of ballast water to reduce concentrations of all organisms prior to discharge.

Alternatives to BWMS

Thirteen commenters disagreed with the requirement for all applicable vessels to install BWMS, and called for the Coast Guard to allow vessels the flexibility to use other approaches, such as discharging to receiving vessels or to shoreside facilities. The Coast Guard agrees. As discussed previously regarding the comments dealing with applicability, we have revised our regulation to clarify that only vessels discharging ballast water into waters of the United States are required to comply with the BWDS requirements at 33 CFR 151.1510 and 151.2025 of this final rule. However, the dependence of the vessel on the availability of appropriate reception facilities must be identified in the vessel's BWM plan, along with the alternative management practices that will be used if and when discharge to a reception facility is not possible. Further, the lack of availability of adequate reception facilities is not an acceptable reason for discharge of ballast water that does not meet the BWDS into the waters of the United States, and such a discharge will constitute a violation of this regulation.

One commenter stated that vessels should be required to discharge to a shore-side treatment facility prior to entering the Great Lakes. The Coast Guard disagrees that vessels should be required to discharge to a shore-side facility. The Coast Guard believes it is important that vessels have the flexibility to select the BWM practice that makes the most sense for their specific circumstances. If vessel owners and operators want to have the option of discharging to shore and sufficient market exists for such an option, then it is likely that such facilities will be created.

One commenter stated that it may not be technically or economically feasible for a vessel owner to retrofit existing vessels with an approved BWMS, and recommended that the Coast Guard allow other BWM options under such circumstances. As described in 33 CFR 151.2025 and 151.2026, ballast water management practices other than use of a Coast Guard-approved BWMS will be allowed.

Additionally, vessels will have the options of discharging to a shoreside treatment facility or receiving vessel, if available, or retaining ballast water onboard. The Coast Guard will evaluate claims that BWMS and other allowed BWM practices are not available for specific vessels and potentially extend the compliance date for those vessels.

Foreign Type Approvals

Eleven commenters discussed the Coast Guard's proposed provision for the acceptance of foreign type approvals of BWMS. Four of the commenters supported the Coast Guard's proposal that such acceptance should be granted only when the foreign procedures are equivalent to those of the Coast Guard. Conversely, six of the commenters stated that the Coast Guard should accept foreign type-approvals without verifying equivalency of testing protocols.

The Coast Guard's approval process is intended to provide a level of assurance that a BWMS is likely to work consistently, effectively (i.e., meet the BWDS), and safely under shipboard conditions. Testing conducted with insufficient rigor or under substantially less challenging conditions will not provide that assurance. The Coast Guard retains the prerogative to verify the equivalency of foreign type-approval procedures before accepting such approvals.

One commenter stated that since the phase-one BWDS is equivalent to the IMO discharge standard, the Coast Guard must consider the protocol in the G8 guidelines to be sufficiently strict. The Coast Guard disagrees, and will assess each foreign administration's type-approval procedures, including test protocols and quality assurance practices, to determine whether the performance assessment conducted by the foreign administration is equivalent to that of the Coast Guard and complies with applicable U.S. domestic laws. We will evaluate, in accordance with the standards in the revised 46 CFR 162.060, the data and supporting information in approval applications submitted by manufacturers whose BWMS have received foreign type approval. We will not grant U.S. type approval to BWMS approved by foreign administrations based on approval procedures that are substantively less rigorous than the U.S. approval testing without additional testing as necessary and appropriate for the specific circumstance.

The Coast Guard recognizes some time will elapse between the publication of this final rule and the availability of U.S. approved BWMS. The Coast Guard believes that ballast water discharged into waters of the United States should undergo some type of treatment designed to reduce the risk of ballast water spreading NIS at the earliest possible date, particularly for those vessels currently unable to conduct BWE, as we believe this will provide greater reduction in the risk of NIS being introduced or spread via ballast water. Therefore, we have added a provision to the final rule to allow for a temporary acceptance of a foreign administration's approval if it can be shown that the foreign-approved BWMS is at least as effective as BWE. This temporary acceptance will be granted for 5 years from the date when the vessel on which the BWMS is installed is required to comply with the BWDS.

Two commenters requested that the rule include more details about the procedures the Coast Guard will follow to make determinations regarding the acceptance of foreign type approvals. The Coast Guard agrees and has made changes to 46 CFR 162.060-12, which are discussed in the Summary of Changes section above. The Coast Guard expects to examine each foreign administration's type-approval report, which should include the testing protocols used and the testing results, and then make a determination as to whether the procedures and criteria used were essentially equivalent in rigor and challenge to those of the Coast Guard. Additionally, in order to grant U.S. type approval or the temporary acceptance (as an AMS), the Coast Guard must comply with NEPA and other applicable environmental laws.

One of the commenters suggested that the Coast Guard use an advisory panel of independent scientists and agency representatives to conduct the

equivalency determinations for foreign administration's type-approval programs. The Coast Guard will make use of appropriate expertise in reviewing proposals for acceptance of foreign type approvals, including, when necessary, consultation with other agencies and outside experts.

One commenter referenced the text in the NPRM preamble that states: “Under today's proposal, foreign vessels equipped with and operating a BWMS that has been approved by a foreign administration would be allowed to use the BWMS for discharging ballast water into U.S. waters if the Coast Guard determines that the foreign administration's approval process is equivalent to the Coast Guard's approval process, the BWMS otherwise meets the requirements of this proposed rule, and the resulting discharge into waters of the U.S. meets the applicable (i.e., phase-one or phase-two) proposed discharge standard.” The commenter suggested that this text be changed to replace “foreign vessel” with “vessel,” so that U.S.-flagged ships which currently have installed BWMS that have been type approved by a foreign administration under the specified conditions would be acceptable.

The Coast Guard has clarified the procedures in 46 CFR 162.060-12 which allow manufacturers of foreign type-approved BWMS to submit data developed during the foreign type-approval testing to support the submission of an application pursuant to 46 CFR 162.060-14. The Coast Guard will evaluate the application and determine if U.S. type approval will be granted. If U.S. type approval is granted, the BWMS can be installed and used on U.S. and foreign flagged vessels.

Availability of BWMS

One commenter stated that it is unlikely that any systems have documented test results to demonstrate compliance with a standard that is 100 or 1,000 times stricter than phase-one. The Coast Guard agrees that no sufficiently credible documentation exists of BWMS able to meet concentrations 100 or 1,000 times more stringent than the proposed phase-one standard. The Coast Guard notes that the EPA SAB came to the same conclusion in its recent report (EPA SAB 2011).

Two commenters stated that BWMS that can meet the Coast Guard's proposed BWDS are available now. The Coast Guard agrees that technologies capable of meeting the phase-one BWDS will be available for installation on applicable vessels on the required implementation schedule. We do not, however, agree that there is a currently available BWMS that has been shown to meet the phase-two BWDS.

In response to the Coast Guard's question, “Are there technology systems that can be scalable or modified to meet multiple stringency standards after being installed?” one commenter stated that technology is available, pending adjustments, for “Lakers,” vessels operating solely on the Great Lakes. The Coast Guard notes that our question specifically asked for quantitative information on technologies, necessary modifications, costs, and sources of such information. The comment did not include quantitative information. Therefore, we are unable to validate this claim.

One State government agency stated that the availability of technology that meets the phase-two standard is demonstrated by the findings of the CSLC report on BWM technologies. This report concluded that at least seven commercially available BWMS had demonstrated the capability to comply with California's performance standards.

The Coast Guard disagrees. In the CSLC 2010 report on the availability of technology to meet California requirements, the State Lands Commission acknowledged the limitations of testing data and clarified that the Commission's analysis determines whether or not systems have demonstrated the potential to comply with California's standards. (CSLC Sept 2010). The “potential to comply” determination was based on whether the reported efficacy data for the systems examined indicated that at least one test (averaged across replicates) met California's standards for every testable organism size class during either land-based or shipboard testing.

It is important to recognize that California's phase 2 discharge standard for organisms greater than 50 micrometers (one millionth of a meter, μm) is “no detectable living organisms,” and is not defined by a specific volumetric concentration (i.e., California's phase 2 discharge standard is not equivalent to a concentration 1,000 times smaller than the IMO standard, or to any other standard expressed as a concentration). In its report, the Commission concluded “Thus, California's standard for this organism size class is not directly comparable to the IMO or standards proposed by other entities evaluated by these reports.”

Because of the difficulties of testing treatment technologies to meet standards more stringent than the IMO's, the Commission convened its Ballast Water Treatment Technology Technical Advisory Panel, which recommended that the best option for California was to maintain the “no detectable organisms” standard for larger organisms, and develop and adopt compliance verification protocols. At this point, it is not known what those protocols, or their detection limits, will be, but is instructive that the EPA SAB concluded that “* * * current test methods and detection limits preclude a complete statistical assessment of whether a BWMS meets any standard more stringent than Phase 1.”

One commenter questioned whether a BWMS will be available to allow the industry to meet the BWM requirements on the schedule proposed in the NPRM. As discussed elsewhere in this preamble, the Coast Guard has made changes to the applicability in order to address this very question. We have also delayed the initial compliance date for new vessels by 2 years to provide time for the U.S. type-approval process to be implemented. It is our belief that there will be suitable BWMS on the market for those vessels required to comply with the BWDS in this final rule. The companies bringing BWMS to the market include many with international supply and service networks. Further, existing information indicates that not all BWMS will need to be installed in drydock or even while the vessel is out of service. However, to address the situation where, through no fault of their own, a vessel owner cannot install a BWMS on time, we have also included a provision allowing the Coast Guard to extend that particular vessel's compliance date.

One commenter stated that treatment technology is not available for barges with large ballast water capacity. The Coast Guard neither agrees nor disagrees with this comment. We recognize that some vessels will present challenges due to the specific nature of their design and operations. We have made adjustments to this final rule's applicability and implementation timeline to allow the Coast Guard to deal with these challenges either on a one-on-one basis (as with a request for an extension of compliance) or up front en masse (as with the removal of certain vessels from the BWDS applicability).

One commenter stated that the design of some vessels is not appropriate for current approaches to BWM and proposed that technical feasibility be taken into account. The commenter specifically referenced the lack of electrical power and personnel available to operate BWMS onboard unmanned, unpowered barges. The Coast Guard agrees that technical feasibility is an

important consideration, and has included it as one of many factors that must be considered during the Coast Guard's practicability review. Two commenters asserted that the installation of BWMS on their vessels would not be economically feasible, but did not provide any additional data. Given the issues raised by these and other commenters, the Coast Guard has revised the applicability of the BWDS rule. The Coast Guard is publishing this final rule to apply the phase-one BWDS only to the following vessels discharging ballast water into water of the United States: vessels entering waters of the United States from outside the EEZ, and those seagoing vessels that operate in more than one COTP Zone and are greater than 1,600 GRT (3,000 GT (ITC)). The Coast Guard has determined that additional analysis is needed before expanding the applicability in this final rule.

Additionally, the Coast Guard has decided the BWM requirements will not include vessels that operate solely in inland waters. The Coast Guard fully intends to expand the BWDS rule to all vessels, as noted in the final rule preamble section V.A. Summary of Changes from the NPRM, but has determined that additional analysis is necessary to support this expansion. We also intend to conduct additional research as necessary.

Eight commenters stated that they were unaware of any available BWMS designed for vessels operating exclusively in freshwater. The Coast Guard disagrees, as there are several BWMS currently on the market or advancing through approval procedures in other countries that are based on treatment processes that function independently of salinity, such as filtration and ultraviolet radiation (UV). Many BWMS using active substances, particularly electrolytic chlorination, can work effectively in freshwater if provided an appropriate source of ions such as seawater or brine held in a tank. While it still remains for these systems to be approved by the Coast Guard, the fact that they are being approved by other countries in accordance with the standards set forth in the IMO BWM Convention for use in meeting a standard equivalent to the phase-one standard indicates there are likely to be BWMS that will be effective when used on vessels that operate exclusively in freshwater.

One commenter stated that BWMS are available that are capable of treating small volumes and flow rates and would fit in vessels with low space availability. The Coast Guard notes this information.

Funding Issues

One commenter stated that it is incumbent on the Coast Guard and Canadian agencies to cooperatively assist companies to design and market BWMS that may need to be unique to the Great Lakes. The Coast Guard disagrees that the government of the United States, either alone or in cooperation with Canada, must assist companies to design and market BWMS beyond encouraging such actions through the establishment a BWDS.

Two commenters asserted that provision of adequate funding is necessary to facilitate the development of technology for treating ballast water and for implementation of the proposed regulation. The availability of funding for either development of technology or implementation of this final rule is outside the scope of this rule.

Four commenters stated that this regulation should include provisions for BWMS testing and application fees to support testing and review processes within Federal agencies and ILs. One submitter commented that there is a need for increased research and development funding for testing and development of BWM technologies. The Coast Guard disagrees that the rule should specify fees for testing and application review. Costs of testing will be determined by the ILs.

Specific BWMS Requirements

One commenter stated that the requirement for the BWMS to retain records of operation for 24 months is excessive and will result in significant additional costs. The commenter proposed instead that the period of record retention in the BWMS be reduced to 6 months, and that data older than that be acceptable if retained on disks. The Coast Guard agrees this would be more efficient and has clarified requirements for record retention to allow for electronic data collection in lieu of a hard copy by revising 46 CFR 162.060-20(b)(5) and (b)(6), and added 33 CFR 151.2070(d).

One commenter stated the Coast Guard should not automatically decertify a formerly approved BWMS when the manufacturer goes out of business or ceases to support a type-approved system. The Coast Guard agrees with the commenter that the issue of concern should be whether or not the BWMS is capable of being operated properly and effectively. The provision for de-certification is included to allow the Coast Guard to suspend approval of BWMS that cannot be properly maintained as a consequence of business decisions by the manufacturer.

One commenter stated the use of an operational, type-approved BWMS should be sufficient for compliance, and that vessel masters should not be held to discharge standards that they cannot themselves measure or understand without specialized scientific or engineering training. The Coast Guard disagrees with the commenter. The intent of NANPCA, as amended by NISA, is to prevent the introduction and spread of unwanted organisms in vessels' ballast water. For this reason, the Coast Guard has proposed a BWDS that we believe is practicable to implement. Type approval alone cannot ensure that vessel discharges meet the BWDS; it can only increase the probability that systems used to meet the BWDS will be effective. It is the vessel owner or operator's responsibility to meet the discharge requirement.

One commenter stated that failure to use an approved BWMS as required should be a violation, even when another allowable practice is used. The Coast Guard believes that the regulations as drafted in the final rule clarify as to whether a violation has in fact occurred would depend on the particular circumstances. Vessels with an inoperable BWMS will be required to inform the appropriate COTP prior to arrival. The COTP will evaluate the circumstances and inform the vessel of required alternatives, as well any finding of a violation that would result in an enforcement action.

Independent Laboratories (IL)

Three commenters questioned whether sufficient numbers of ILs will exist that can perform the required testing of BWMS for type approval. The Coast Guard acknowledges the key role that ILs will play in the type-approval process. The Coast Guard is aware of several organizations in the United States and abroad that have stated their intention to serve as ILs and that have taken steps to create the infrastructure and organizational capacities to perform the functions. The Coast Guard will not know definitively whether enough organizations capable of conducting the test procedures exist until such time as organizations apply for designation by the Coast Guard and are determined to meet the requirements for ILs testing BWMS. The Coast Guard will move quickly to announce its availability to accept applications for designation.

Five commenters discussed the importance of having a sufficient availability of qualified ILs for effective and timely implementation of the proposed rule. The Coast Guard agrees

that, as with other installed vessel equipment, ILs will play a critical role in ensuring that marketed technologies are highly likely to meet the regulatory requirements for which they are intended. It is our belief that the publication of this final rule, as well as our stated intent to follow up with a subsequent rule implementing a more stringent standard after additional analysis and research, will provide incentive for the creation of additional ILs.

Two commenters stated that the Coast Guard should audit ILs to ensure the integrity of the testing process. The Coast Guard agrees; audits are a standard component of the Coast Guard's oversight of ILs (46 CFR subpart 159.010).

Four commenters discussed ILs in reference to existing test facilities. Three advised that existing facilities that conduct tests of BWMS, particularly the Great Ships Initiative (GSI), should be utilized as ILs. One commenter advised the Coast Guard to work closely with established programs and other appropriate experts to develop testing procedures. The Coast Guard is aware of most, if not all, existing test facilities in the United States and internationally, including GSI, and would welcome IL applications from any qualified organization once the procedures for certification of ILs are implemented. The Coast Guard has worked with most of the existing test facilities in the United States in the development of standard test procedures for BWMS under the EPA ETV Protocol and will continue to do so.

One commenter stated that the timeframe for designation of ILs should be specified. The Coast Guard disagrees that specification of the time frame for designation of ILs should be part of the regulation. There are too many unknowns prior to receiving the applications to be able to set a deadline. Additionally, there should be no limit on a facility's opportunity to apply to become an IL after the initial round of applications and approvals are completed.

Three commenters requested, respectively, that academic institutions, classification societies, and agencies of foreign governments be eligible for consideration as ILs. The Coast Guard agrees with the commenters. We consider the existing specifications for ILs in 46 CFR 162.060-3 and 162.060-40 to be inclusive of the types of organizations identified by these commenters.

Three commenters called for the Coast Guard to approve a specific list of entities that could be accepted as ILs. The Coast Guard disagrees with the recommendation. Listing specific entities in the regulation could serve as a disincentive to other entities who could also meet all of the requirements to become an IL. The Coast Guard will make publicly available a list of accepted ILs on the Coast Guard Maritime Information Exchange (CGMIX) Web site,

http://cgmix.uscg.mil/.

Three commenters recommended that the Coast Guard include provisions for adequate funding for its Federal activities and the activities of the ILs in this regulation. Two of the commenters specifically suggested setting fees for application review and testing. The Coast Guard clarifies that type-approval applicants must handle all IL testing costs through individual contracts for services with ILs. The Coast Guard currently does not have express authority to charge fees for implementing these BWM requirements.

Two commenters urged the Coast Guard to presumptively accept certified IL test results without conducting substantial additional reviews, in the interest of streamlining the type-approval process and avoiding unnecessary delays in making approved systems available. The Coast Guard agrees that delays should be minimized. The point of designation and regular oversight of ILs via audits is to avoid the need for time-consuming reviews of individual test reports. However, the Coast Guard must assess each individual test report for the BWMS being tested, and make an independent determination of the BWMS. This obligation cannot be delegated to the ILs. Additionally, the Coast Guard's type-approval determination is a Federal agency action that must be analyzed under NEPA and other applicable U.S. environmental laws.

Two commenters specifically supported the Coast Guard's proposed use of ILs to conduct testing associated with type-approval determinations.

One commenter recommended that a manufacturer or vendor should be allowed to use multiple ILs as necessary and efficient during the different phases of approval testing. The Coast Guard agrees that a BWMS vendor may use the services of more than one entity to most effectively conduct the required tests, and there are provisions in this final rule that allow for this. However, in the interest of organizational and administrative efficiency, the Coast Guard requires that one IL coordinates and oversees all testing and reporting for each type-approval application.

Changes to Specific Sections

Two commenters stated that all uses of “should” in 33 CFR 151.2050 need to be changed to “must” to reflect the fact that the previously voluntary provisions are now requirements. The Coast Guard agrees. We have revised 33 CFR 151.2050 accordingly.

One commenter requested that the definition of “major conversion” be consistent with the definition of the term in the IMO BWM Convention. The Coast Guard disagrees; we did not propose any changes to the “major conversion” definition in the NPRM, and do not believe any change is necessary at this time.

One commenter recommended changing the text in 33 CFR 151.2005(b) to revise the definition of “empty/refill exchange” to replace the word “should” with the word “must.” The Coast Guard agrees that the wording needs to reflect the mandatory nature of the requirement, thus we have revised the text accordingly.

One commenter called for the Coast Guard to revise the text of 33 CFR 151.2040(a) to read that a vessel retains “all of its ballast water,” instead of “its ballast water,” as currently written. The Coast Guard disagrees that the change is necessary, as the existing text is already inclusive.

Two commenters requested that the text in 33 CFR 151.2040 and 151.2045 clearly state that the responsibility to meet the legal requirements of the regulation still applies to vessels that claim extraordinary circumstances or invoke the safety exemption. The commenters presumed that while the infraction would exist, fines or penalties would be mitigated to reflect the circumstances. The Coast Guard agrees with the commenters' presumption. Vessels unable to meet the BWM requirements will be required to inform the COTP prior to arrival. The COTP will evaluate the circumstances and direct the vessel accordingly, which may include the imposition of fines or penalties.

One commenter recommended that the introductory paragraphs of the appendix to subpart D of 33 CFR part 151—Ballast Water Reporting Form and Instructions for Ballast Water Reporting Form introductory paragraph be revised to change the word “should” to the word “must.” The Coast Guard does not believe this change is necessary, as the legal requirement to submit amendments is clearly laid out in 33 CFR 151.2060(c). Additionally, as discussed earlier in this preamble, we are removing the Ballast Water Reporting Form from the CFR (

see

V.A.

Summary of Changes from the NPRM). We will keep the comment in mind, however, and reevaluate it when we update the OMB approved collection as part of our next regularly scheduled renewal package.

One commenter recommended revising 46 CFR 162.060-32 by changing “appropriate dosages” to “appropriate dosages over all applicable temperatures” to reflect the fact that chemical and biological processes are temperature dependent. The Coast Guard agrees and has included the clarifying language in the final rule text.

One commenter stated that because some types of treatment processes, such as UV, may act to make organisms unviable or unable to reproduce rather than killing them outright, the Coast Guard should include viability as a criterion for determination of BWMS efficacy. The Coast Guard disagrees. This issue has been the point of much discussion both in the United States and internationally in association with the IMO BWM Convention. The Coast Guard has decided to use live/dead rather than viable/unviable, because the latter designations would require culturing potentially large numbers of different kinds of organisms to determine whether they were capable of reproduction. This would be made even more problematic by the fact that scientists are not able to culture many of the organisms in question. Finally, it is more conservative, and thus more protective, to base efficacy decision on the basis of live/dead, rather than viable/unviable.

One commenter stated, in reference to 46 CFR 162.060-20(b)(5), that a BWMS should not have to record all by-passes of the BWMS. Rather, the commenter thought that such recording should be allowable either through electronic or hand entry in the logbook. The Coast Guard agrees and has revised the provision accordingly.

One commenter stated that a strong, environmentally protective, concentration-based, numerical, national BWDS is a critical and necessary component of the nation's invasive species program. The Coast Guard agrees.

One commenter requested a definition of the term “Test Plan” as it is used in the approval text in 46 CFR 162.060-10(d). The Test Plan is a document that describes the procedures for conducting a test or study according to protocol requirements for a specific BWMS at a particular test site. At a minimum, the Test Plan includes detailed instructions for test procedures, sample and data collection, sample handling and preservation, precision, accuracy, goals, quality assurance, and quality control procedures relevant to the particular site. We have not included a definition of Test Plan, but we have detailed the necessary requirements in 46 CFR 162.060-24. These details were included in the NPRM, as well.

One commenter asked the Coast Guard to clarify the definition of “change in design” in 46 CFR 162.060-16(a), and recommended following the same approach we used in defining “major conversion” as applied to a vessel. Another commenter stated the Coast Guard should better define what is meant by a “design change” in 46 CFR 162.060-16.

The Coast Guard disagrees that additional explanation is necessary. The language is the same as for other pollution prevention equipment subject to Coast Guard-approval. With the language as it is written, any change in the design of an approved BWMS must be submitted to the Coast Guard for review.

One commenter stated that the wording in 46 CFR 162.060-20(h) is too inflexible, and that the paragraph's goals could be achieved through assessments of individual systems. The Coast Guard disagrees. The requirements in 46 CFR 162.060-20(h) are important for the safe and effective operation of BWMS. If a developer considers that the requirements may be best met through other than “equipped with a means to * * *”, then the developer may discuss alternatives with the Coast Guard.

Responses to Questions Posed in NPRM

One commenter stated, in response to the NPRM preamble question on costs, that it is not possible to estimate costs for BWMS capable of meeting higher stringency standards because such systems do not exist. The Coast Guard is currently undertaking additional studies to estimate the costs of BWMS capable of meeting more stringent standards.

One commenter stated, in response to another NPRM preamble question, that it is not feasible to assess whether BWMS are sufficiently scalable to be able to meet multiple stringency standards until methods and facilities capable of testing to the more stringent standards are available. The Coast Guard agrees that more exacting methods and improved facilities are needed to test to the more stringent standards.

One commenter responded to a specific question on industry readiness to implement the phase-two standard by stating that ILs and vendors are ready to implement the phase-two standard in 2014 (in place of phase-one). The Coast Guard disagrees with this comment. To date, there are no ILs (as defined in this rule), nor to the knowledge of the Coast Guard are there test facilities or vendors that have demonstrated their readiness to implement the phase-two standard in 2014. We again note the conclusion of the EPA SAB that test methods are not available to determine whether a BWMS meets any standard more stringent than the IMO's.

4. Approval Protocols

General

Two commenters said that they would accept a greater chance of type two statistical errors in determining whether BWMS were working effectively. The Coast Guard disagrees. A type two statistical error is when one accepts a null hypothesis (a hypothesis that is false) as true. In the case of approving BWMS, this would mean increasing the probability of approving a BWMS when it does not actually meet the BWDS.

Five submitters commented on the make-up of test organisms in challenge water, and on the use of cultured organisms. Two commenters recommended that specific concentrations of organisms be required in challenge conditions. One advocated requiring challenge water to have 100 times the threshold concentrations in the BWDS (for example, 1,000 organisms larger than 50 micrometers per m

3

for phase one and 1 organism larger than 50 micrometers per m

3

for the phase-two standard). The other commenter stated that the Coast Guard should establish minimum test conditions of 50,000 organisms larger than 50 micrometers per m

3

of water for all trials, with at least three trials having more than 100,000 organisms per m

3

of water; 1,000 organisms per m

3

of water for organisms between 10 and 50 micrometers in all replicate trials, with at least three trials having more than 2,000 organisms per m

3

of water; 10,000 colony forming units (cfu) of heterotrophic bacteria per mL of water; total suspended solids of 25 mg per L; dissolved organic carbon of 5 mg per L, and particulate organic carbon of 5 mg per L.

The Coast Guard disagrees and will not make these specific changes. The Coast Guard based the approval challenge conditions on those in the ETV Protocol, which is the product of a consensus process based on input from numerous experts from a wide range of scientific and engineering disciplines. As such, the ETV Protocol constitutes the best available validated procedure for evaluating BWMS. The issues raised by the commenters were

considered in the development of the ETV Protocol.

Two commenters called for publication of the testing protocols and procedures used by ILs prior to implementation of the phase-one standard in order to ensure transparency. The Coast Guard agrees with this comment. This final rule, as well as the NPRM before it, describes, in detail, the procedures and protocols for use by ILs in testing BWMS for purposes of type approval (

see

46 CFR part 162.060).

One commenter stated the Coast Guard should review and revise the protocols for assessing biological and operational performance and environmental soundness of systems annually. The commenter further stated the reviews should be based on findings from type approvals, compliance tests, and independent research, and that these findings should be made publicly available in a database maintained by the Coast Guard and the EPA.

The Coast Guard agrees that the protocols should be reviewed regularly and that the performance data for BWMS should be publicly available, consistent with applicable privileges covering commercially sensitive information.

The Coast Guard disagrees that review and revision should occur annually and that performance data should necessarily be made available through a database. Under NISA, the Coast Guard must assess and as appropriate revise our ballast water regulations at least every 3 years. It remains to be seen what the most efficient and practicable method will be for making performance data available to the public. As the U.S. approval process evolves, we will evaluate the most efficient means for making information available to the public, as well as the appropriate time frame for conducting reviews.

Two commenters stated that the Coast Guard should base the approval testing and certification procedures on those laid out in the G8 guidelines and Procedure for Approval of Ballast Water Management Systems that make use of Active Substances (G9) (G9 procedure), which were developed to assist implementation of the IMO BWM Convention. The Coast Guard agrees with these commenters to a certain extent. The Coast Guard attempted to harmonize our type-approval procedures with these references to the extent practicable, and the proposed type-approval procedures do not conflict with those under the IMO BWM Convention. However, the G8 guidelines in particular are very unspecific on important details, subject to interpretation by individual administrations, and do not wholly reflect advances in ballast water science and technology that have occurred since the adoption of the G8 guidelines in 2005. The G9 procedure addresses the acceptability of chemicals used to treat ballast water. The closest parallel to the G9 procedure in the United States is the registration of biocides under FIFRA, which is administered by the EPA, not the Coast Guard.

Three submitters addressed the need for the Coast Guard's approval application review process to be completed in a timely fashion. Two of these three called for the Coast Guard to specify, in the regulations, the timeframes for review and approval of BWMS. The Coast Guard disagrees that the timeframe for review and decision should be specified in the regulation. A number of the components of the approval process, including environmental reviews and reviews to be completed by other Federal agencies, are inherently not amenable to pre-set timeframes. The Coast Guard appreciates the importance of minimizing the time required for review of applications, and will make efforts to do so.

EPA ETV Protocol

Six commenters urged the Coast Guard to release a final version of the EPA ETV Protocol for verification of BWMS. We agree that the final ETV Protocol is a key component to this rule and, as discussed previously, we have incorporated it by reference into our final rule at 46 CFR 162.060-5. We note that EPA released the ETV protocol in September 2010, and that it is available on the ETV web page (

http://www.epa.gov/nrmrl/std/etv/vp.html#wqpc

).

Two commenters urged the Coast Guard to use the EPA ETV Protocol as the basis for the approval tests to assess performance of BWMS in meeting the BWDS. Conversely, one commenter did not support the use of the revised ETV Protocol as the basis of the approval test procedures. The Coast Guard has adopted the ETV Protocol. The ETV Protocol is the product of a consensus process based on input from numerous experts from a wide range of scientific and engineering disciplines. As such, the ETV Protocol constitutes the best available validated procedure for evaluating BWMS.

The Coast Guard will work with EPA and other stakeholders to update the ETV Protocol as necessary and appropriate in the future. If future updates are made, we would update our rules and policies as necessary to reflect the ETV Protocol to be used in the U.S. approval process.

Two commenters called for the Coast Guard to define protocols and methods for approval testing that are clear and practicable. One commenter requested that Coast Guard do this prior to the implementation of the approval process. In this final rule, the Coast Guard has established procedures to be followed for shipboard testing as well as adopting the ETV Protocol. We believe these regulations are clear, but also anticipate issuing guidance to help manufacturers and vendors work their way through the U.S. approval process.

One commenter considered the proposed requirements for type approval to be thorough and well done. The Coast Guard notes their submission and endorsement of the protocols.

Land-Based Testing

One commenter stated that the land-based test protocols should include a requirement that the concentration of organisms in the discharge from control tanks be at least ten times the discharge limit set by the BWDS.

One commenter recommended the Coast Guard should consider requiring three short-term tests (18-24 hrs) and five 3-5 day tests at each of the required test facilities to enhance certainty that treatment systems will be effective over a range of voyage durations.

One commenter stated that required holding times for land-based tests should be 5 days, but that longer or shorter periods should be added as warranted by specific BWMS.

The Coast Guard disagrees and will not make these specific changes. The Coast Guard based the approval requirements for land-based testing on those in the ETV Protocol, which is the product of a consensus process based on input from numerous experts from a wide range of scientific and engineering disciplines. As such, the ETV Protocol constitutes the best available validated procedure for evaluating BWMS. The issues raised were considered in the development of the ETV Protocol.

One commenter stated that test tanks should be the unit of repl

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