[Federal Register Volume 80, Number 230 (Tuesday, December 1, 2015)]
[Notices]
[Pages 75093-75094]
[FR Doc No: 2015-30424]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice Of Filings #2

    Take notice that the Commission received the following electric
rate filings:
    Docket Numbers: ER15-527-003.
    Applicants: PJM Interconnection, L.L.C.
    Description: Compliance filing: Compliance Filing per 9/24/15 Order
in Docket No. ER15-527 to be effective 5/15/2015.
    Filed Date: 11/23/15.
    Accession Number: 20151123-5190.
    Comments Due: 5 p.m. ET 12/14/15.

    Docket Numbers: ER16-95-001.
    Applicants: Midcontinent Independent System Operator, Inc.
    Description: Tariff Amendment: 2015-11-23_SA 2834 Amended ATC-NSPW
Design and Construction Agreement to be effective 12/15/2015.
    Filed Date: 11/23/15.
    Accession Number: 20151123-5151.
    Comments Due: 5 p.m. ET 12/14/15.

    Docket Numbers: ER16-128-001.
    Applicants: Midcontinent Independent System Operator, Inc.
    Description: Tariff Amendment: 2015-11-23_SA 2855 Amended ATC-
Manitowoc Relocation Agreement to be effective 12/20/2015.
    Filed Date: 11/23/15.
    Accession Number: 20151123-5160.
    Comments Due: 5 p.m. ET 12/14/15.

    Docket Numbers: ER16-375-000.
    Applicants: PJM Interconnection, L.L.C.
    Description: Tariff Cancellation: Notice of Cancellation of WMPA SA
No. 3740, Queue No. X1-110 to be effective 11/23/2015.
    Filed Date: 11/23/15.
    Accession Number: 20151123-5113.
    Comments Due: 5 p.m. ET 12/14/15.

    Docket Numbers: ER16-376-000.
    Applicants: West Chicago Battery Storage LLC.
    Description: Sec.  205(d) Rate Filing: Revised Market-Based Rate
Tariff to be effective 1/23/2016.
    Filed Date: 11/23/15.
    Accession Number: 20151123-5116.
    Comments Due: 5 p.m. ET 12/14/15.

    Docket Numbers: ER16-377-000.
    Applicants: Joliet Battery Storage LLC.
    Description: Sec.  205(d) Rate Filing: Revised Market-Based Rate
Tariff to be effective 1/23/2016.
    Filed Date: 11/23/15.
    Accession Number: 20151123-5119.
    Comments Due: 5 p.m. ET 12/14/15.

    Docket Numbers: ER16-378-000.
    Applicants: NorthWestern Corporation.
    Description: Compliance filing: Revised Market-Based Rate Tariff to
be effective 10/1/2015.
    Filed Date: 11/23/15.
    Accession Number: 20151123-5148.
    Comments Due: 5 p.m. ET 12/14/15.

    Docket Numbers: ER16-379-000.
    Applicants: Battery Utility of Ohio, LLC.
    Description: Sec.  205(d) Rate Filing: Revised Market-Based Rate
Tariff to be effective 1/23/2016.

    Filed Date: 11/23/15.
    Accession Number: 20151123-5180.
    Comments Due: 5 p.m. ET 12/14/15.

    Docket Numbers: ER16-380-000.
    Applicants: NorthWestern Corporation.
    Description: Sec.  205(d) Rate Filing: SA 290 Sixth Rev--NITSA with
Oldcastle Materials Cement Holdings to be effective 1/1/2016.
    Filed Date: 11/23/15.
    Accession Number: 20151123-5197.
    Comments Due: 5 p.m. ET 12/14/15.

    Take notice that the Commission received the following electric
reliability filings
    Docket Numbers: RD16-2-000.
    Applicants: North American Electric Reliability Corporation.
    Description: Petition of the North American Electric Reliability
Corporation for Approval of Proposed Reliability Standard PRC-005-6.
    Filed Date: 11/13/15.
    Accession Number: 20151113-5283.
    Comments Due: 5 p.m. ET 12/8/15.

    The filings are accessible in the Commission's eLibrary system by
clicking on the links or querying the docket number.
    Any person desiring to intervene or protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00
p.m. Eastern time on the specified comment date. Protests may be
considered, but intervention is necessary to become a party to the
proceeding.
    eFiling is encouraged. More detailed information relating to filing
requirements, interventions, protests, service, and qualifying
facilities filings can be found at: http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other information, call<PHONE_NUMBER>
(toll free). For TTY, call<PHONE_NUMBER>.

    Dated: November 23, 2015
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2015-30424 Filed 11-30-15; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 77, Number 154 (Thursday, August 9, 2012)]
[Rules and Regulations]
[Pages 47544-47552]
[FR Doc No: 2012-19376]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

46 CFR Part 2

[Docket No. USCG-2007-27668]
RIN 1625-AB35

Approval of Classification Societies

AGENCY: Coast Guard, DHS.

ACTION: Final rule.

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SUMMARY: Federal law requires that classification societies conducting
certain work in the United States be approved by the Coast Guard. In
this rule, we finalize application procedures and performance standards
that classification societies must meet in order to obtain approval by
the Coast Guard. Through this final rule, we seek to improve marine
safety and environmental protection by assuring the consistency and
quality of work conducted by classification societies that review,
examine, survey, or certify the construction, repair, or alteration of
a vessel in the United States.

DATES: This final rule is effective September 10, 2012.
    The incorporation by reference of certain publications listed in
the rule is approved by the Director of the Federal Register on
September 10, 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-2007-27668 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-2007-27668 in the ``Keyword'' box, and then clicking
``Search.''

FOR FURTHER INFORMATION CONTACT: If you have questions on this rule,
call or email LT Alfred Giordano, Office of Design and Engineering
Standards (CG-ENG-1), Coast Guard; telephone<PHONE_NUMBER>, email
<EMAIL_ADDRESS>If you have questions on viewing the
docket, call Renee V. Wright, Program Manager, Docket Operations,
telephone<PHONE_NUMBER>.

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. Comments Received After Reopening the Comment Period
    B. Changes Made to Address the 2010 Act
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

ABS American Bureau of Shipping
CFR Code of Federal Regulations
DHS Department of Homeland Security
FR Federal Register
IACS International Association of Classification Societies
ICLL International Convention on Load Lines, 1966
IMO International Maritime Organization
ISO International Organization for Standardization
MARPOL 73/78 International Convention for the Prevention of
Pollution from Ships, 1973, as modified by the Protocol of 1978
relating thereto
MOU Memorandum of Understanding
NARA National Archives and Records Administration
NAICS North American Industry Classification System
NEPA National Environmental Policy Act of 1969
NPRM Notice of Proposed Rulemaking
NTTAA National Technology Transfer and Advancement Act
OMB Office of Management and Budget
RO Recognized Organization
SBA Small Business Administration
SOLAS International Convention for the Safety of Life at Sea, 1974,
as amended
U.S.C. United States Code

II. Regulatory History

    We published a notice of policy and a request for comments that
outlined the procedures by which classification societies could apply
for approval with the Coast Guard. See 69 FR 63548 (November 2, 2004).
This notice of policy was based on the August 9, 2004 enactment of
Section 413 of the Coast Guard and Maritime Transportation Act of 2004
(``the 2004 Act'') (Pub. L. 108-293). The 2004 Act amended 46 U.S.C.
3316 by adding paragraph (c), which prohibits certain activities on a
vessel in the United States by classification societies that have not
been approved by the Coast Guard. The 2004 Act mandated that, after
December 31, 2004, a classification society, including an employee or
agent of that society, may not review, examine, survey, or certify the
construction, repair, or alteration of a vessel in the United States
unless the classification society is either approved by the Coast Guard
or is a full member of the International Association of Classification
Societies (IACS).
    After publication of the notice of policy, we received two
questions from the public that were addressed in a Notice of Proposed
Rulemaking (NPRM) published in the Federal Register on April 23, 2010.
The NPRM, entitled ``Approval of Classification Societies'' (75 FR
21212), outlined the procedures and criteria we would use to evaluate
classification societies. The comment period closed on July 22, 2010,
and we received no comments on the proposed rule. No public meeting was
requested and none was held.
    On October 15, 2010, the enactment of section 622 of the Coast
Guard Authorization Act of 2010 (the ``2010 Act'') (Pub. L. 111-281)
amended 46 U.S.C. 3316(c). The 2010 Act changed the provision's
applicability to require all classification societies, including IACS
members, to be approved by the Coast Guard prior to conducting any work
on a vessel in the United States. Because of the 2010 Act's
applicability changes, we reopened the comment period to allow for any
additional or updated comments from the public on our plan to remove
the proposed rule's exemption for IACS members, and apply the proposed
rule to all classification societies seeking Coast Guard approval,
including IACS members. See 76 FR 47531 (August 5, 2011). The comment
period closed on September 6, 2011, and 4 commenters with 11 comments
responded to the revised proposal. No public meeting was requested and
none was held.

III. Basis and Purpose

    This final rule codifies into Title 46 of the Code of Federal
Regulations (CFR) the procedures and criteria to evaluate
classification societies in accordance with 46 U.S.C. 3316(c) in order
to have a specific, consistent, and enforceable basis for approval
determinations.

IV. Background

    To incorporate the requirements of 46 U.S.C. 3316(c) into
regulations, we deem the International Maritime Organization (IMO)
Resolution A.739(18), ``Guidelines for the Authorization of
Organizations Acting on Behalf of the Administration,'' to provide a
sound and internationally recognized standard on which to base our
classification society review and approval program.
    The IMO acknowledges that a classification society often acts as a
Recognized Organization (RO) under authority delegated by a flag state
administration when it performs technical and survey work on behalf of
that administration. Recognizing this relationship, IMO Resolution
A.739(18) adopted guidelines for minimum competency standards for ROs
that act on behalf of flag state administrations to conduct vessel
examinations, issue international certificates, perform surveys and
certifications, and determine vessel tonnage in accordance with
applicable international requirements. In addition, the IMO guidelines
are consistent with our minimum standards for a classification society
to qualify as a Coast Guard-recognized organization in accordance with
46 CFR part 8, ``Vessel Inspection Alternatives.''
    To perform work on behalf of a flag state administration that uses
the IMO guidelines, an RO must sufficiently demonstrate that its
business practices meet or exceed the performance standards described
in IMO Resolution A.739(18). For example, the RO must show that it--
     Publishes and systematically maintains rules for the
design, construction, and certification of vessels;

     Is professionally staffed with strategically placed
resources for geographic coverage;
     Maintains a high level of professional ethics;
     Is competent;
     Provides timely and quality services; and
     Maintains an internal quality system no less effective
than the International Organization for Standardization (ISO) 9000
series certification. (For information on these standards or on ISO,
see www.iso.ch.)
    When an RO demonstrates these competencies to the satisfaction of
the flag state administration, its authorization is documented by that
administration in a formal written agreement under the recommendations
of IMO Resolution A.739(18).
    Similarly, all classification societies must meet the following
requirements for approval under the provisions of 46 U.S.C. 3316(c):
     Vessels surveyed by the classification society must have
an adequate safety record.
     The classification society must have an adequate program
to--
    [cir] Develop and implement safety standards for the vessels it
surveys;
    [cir] Make its safety records available in an electronic format;
    [cir] Make the safety records of a vessel survey available to other
classification societies; and
    [cir] Request safety records from other classification societies
that previously surveyed a vessel for the purpose of a specific vessel
survey.
    To better assess classification societies, we evaluate how these
societies implement safety standards for vessels by examining worldwide
port state control statistics for each society and the vessels it
surveys. These data normally appear in annual reports published by the
world's regional port state control organizations. Some of these annual
reports are not available online. These organizations include, but are
not limited to, the following organizations created under regional
memoranda of understanding (MOU):
     Paris Memorandum of Understanding on Port State Control
(Paris MOU: www.parismou.org).
     Memorandum of Understanding on Port State Control in the
Asian-Pacific Region (Tokyo MOU: www.tokyo-mou.org).
     Mediterranean Memorandum of Understanding on Port State
Control (Med MOU: www.medmou.org).
     Black Sea Memorandum of Understanding on Port State
Control (Black Sea MOU: www.bsmou.org).
     The Latin American Agreement on Port State Control of
Vessels (Vina del Mar MOU: www.acuerdolatino.int.ar).
     West and Central Africa Memorandum of Understanding on
Port State Control (Abuja MOU: www.abujamou.org).
     Riyadh Memorandum of Understanding on Port State Control
in the Gulf Region (Riyadh MOU: www.riyadhmou.org).
     Indian Ocean Memorandum on Port State Control (Indian
Ocean MOU: www.iomou.org).
     Caribbean Memorandum of Understanding on Port State
Control (Caribbean MOU: www.caribbeanmou.org).
    These MOU are regional agreements among countries to share port
state control inspection results with the aim of eliminating the
operation of substandard ships. Typically, MOU are managed by
secretariats that maintain databases of inspection activities and
results and often compile the data into annual reports. The annual
reports normally compiled by the MOU secretariats are available to the
public and identify, among other things--
     Vessel names and particulars;
     Inspection dates and locations;
     Classification societies;
     Deficiencies noted;
     Detentions imposed;
     Detained vessels; and
     Banned and targeted vessels.
    For information on U.S. port state control results and the regional
MOUs, see www.uscg.mil/hq/g-m/pscweb/index.htm. A copy of the most
recent annual report from the United States and the regional
organizations can be found in this docket.
    We can evaluate the performance of a particular classification
society by scrutinizing the port state control history of the vessels
it surveys. For example, an annual report from a major MOU secretariat
typically includes 3 years of data showing the performance of all ships
listed by administration and RO. The RO is usually a classification
society.
    These shared port state control data are indispensable in
evaluating the safety performance of flag state administrations and
classification societies. Not only can we check performance from the
data in the annual reports, we can also track trends from year to year.

V. Discussion of Comments and Changes

    We received no comments from the NPRM published on April 23, 2010.
Since the publication of the NPRM, the 2010 Act required all
classification societies, without exemption, to seek Coast Guard
approval prior to working on a vessel located in the United States.
Accordingly, we reopened the comment period (76 FR 47531).

A. Comments Received After Reopening the Comment Period

    We received 11 comments from 4 commenters in response to the NPRM
after the reopening of the comment period.
    Two commenters requested that a classification society that has
qualified as a Coast Guard-recognized organization under 46 CFR part 8
to conduct work on behalf of the Coast Guard on U.S. flagged vessels be
exempted from the proposed rule. We have determined that we lack the
authority to grant wholesale exemptions to the requirement in 46 U.S.C.
3316(c)(1) that every classification society ``appl[y] for approval
under this subsection,'' and that section 3316(c)(2) requires us to
``review[] and approve[] that society'' under that subsection.
    However, we will deem compliance with the application procedures in
46 CFR part 8 to satisfy the new application procedures under new 46
CFR subpart 2.45 promulgated by this rule. Consistent with the statute,
we are requiring any Coast Guard-RO seeking approval as a
classification society under this rule to explicitly request that the
Coast Guard evaluate their 46 CFR part 8 application materials under
this rule as well. Upon receiving such notice, we will treat the part 8
application materials as an application under this subpart. If we need
additional information to perform our review, we will take the
appropriate action to notify the classification society and give them
an opportunity to submit the information to us.
    One commenter requested that his or her organization be
automatically approved under 46 U.S.C. 3316(c)(1) and under the
proposed rule. The commenter argued that such approval was justified
because the organization is identified in 46 U.S.C. 3316(a) by name as
an agent on behalf of the U.S. Government in classifying vessels owned
by the Government. Also, the organization is recognized by the Coast
Guard and authorized as a recognized organization of the Coast Guard
pursuant to the requirements of Coast Guard regulations in 46 CFR part
8 pursuant to 46 U.S.C. 3316(b)(1).
    We agree with the commenter that the organization is identified as
the sole classification society for U.S. Government-owned vessels.
However, based on the reasoning previously stated, we cannot
automatically approve

any organization as a classification society. Section 3316(c)(1) of 46
U.S.C. requires that every classification society make application to
the Coast Guard for approval and that the Coast Guard assess the
conduct of the classification society under 46 U.S.C. 3316(c)(2). An
automatic approval would violate both the application requirement and
the assessment requirement. As stated above, however, we will deem
compliance with the application procedures in 46 CFR part 8 to satisfy
the new application procedures under new 46 CFR subpart 2.45, provided
each applicant submits indication that they all wish to be assessed
under the new regulations in 46 CFR subpart 2.45 to become an approved
classification society.
    Additionally, the same commenter asked that we clarify in the final
rule whether the detention rate is based on all vessel detentions or
specifically RO-related detentions. We agree that clarification is
necessary. An RO detention occurs when a vessel is detained due to a
deficiency which is the result of an activity by an RO. Therefore, we
will amend the regulatory text to specify that the detention rate is
based specifically on RO-related detentions.
    One commenter felt that the final rule does not list clear or
specific criteria for annually reevaluating the records of
classification societies to ensure they continue to meet the conditions
for approval. The same commenter also stated that if the re-evaluation
criteria include data from global port state control regimes, then some
previously approved classification societies would have poorer records
than some classification societies that are not approved. The same
commenter expressed the hope that the requirement in Sec.  2.45-15
would not amount to annual auditing of classification societies
performance processes.
    We agree that the proposed rule did not explicitly list the
criteria for annually reevaluating the performance of a classification
society. However, as stated in the NPRM (see 75 FR page 21215), we will
``annually reevaluate the records of approved classification societies
to ensure they continue to meet the conditions for approval.'' It was
and remains our intention to use the approval requirements listed in
Sec.  2.45-15 to annually reevaluate the performance of approved
classification societies. We also agree that it is possible for us to
find during a re-evaluation that an approved classification society has
a poor performance record based on data collected from global port
state control regimes. If we determine that a previously approved
classification society no longer meets the requirements in Sec.  2.45-
15, then we will take corrective action per Sec.  2.45-20.
    While we appreciate the commenter's concern, annual review of a
classification society's performance is necessary to ensure that the
classification society is in compliance with the requirements set forth
in the regulations.
    One commenter had six comments, discussed as follows.
    The commenter asked that we clarify the scope of ``repair'' in
light of the fact that repairs to the hull, equipment, and machinery
can be made at any time as a result of an accident or survey work.
Repair includes, but is not limited to, any work done to the hull,
equipment, or machinery that restores the item to its original design
or intended operating condition.
    The commenter requested that we clarify whether a classification
society would be allowed to conduct surveys ``whether they be
periodical (annual, intermediate and renewal) or occasional and to
issue certificates even if they are not approved by the Coast Guard.''
A classification society that is not approved by the Coast Guard would
be permitted to conduct surveys and issue certificates to a vessel if
that vessel is not undergoing or has not completed any construction,
repair, or alteration in the United States.
    Next, the commenter took issue with the requirement proposed in
Sec.  2.45-15(a)(6)(i) that a classification society must use a system
to make its safety records available to the Coast Guard. The commenter
believes the provision does not define or sufficiently clarify the
scope of information to be provided as part of a vessel's safety
records, thereby risking the disclosure of commercially sensitive and
confidential information of ship owners to parties who should not be
privy to that information.
    We appreciate the commenter's concern; however, to determine
whether the vessels surveyed by a classification society have an
adequate safety record, the classification society would be required to
provide all records we formally request. We would request only those
records that are necessary to adequately determine the performance of a
classification society with respect to safety and, except as required
by law, would not disclose those records to any parties with competing
interests.
    The same commenter stated that Sec.  2.45-15(a)(6)(ii), which
requires a classification society to have in place a system to provide
its safety records to other classification societies when requested, is
redundant because of existing procedures for sharing data. We
appreciate the commenter's concern; however, 46 U.S.C.
3316(c)(2)(B)(iii) mandates that the Coast Guard require classification
societies to make their safety records available to all relevant
parties.
    Next, the commenter was concerned with the proposed requirement in
Sec.  2.45-15(5) that requires that a country for which a
classification society is an RO must be a signatory to the
International Convention for the Safety of Life at Sea, 1974, as
amended, (SOLAS); the International Convention for the Prevention of
Pollution from Ships, 1973, as modified by the Protocol of 1978
relating thereto (MARPOL); and the International Convention on Load
Lines, 1966 (ICLL). The commenter felt that this requirement may cause
an adverse situation because a flag state would be compelled to ratify
the aforementioned international conventions simply to have its RO meet
the Coast Guard's requirement. We disagree that this requirement would
create an adverse situation. By ratifying the SOLAS, MARPOL, and ICLL
conventions, a flag state would join the majority of flag states that
have ratified these conventions and help ensure that their vessels
improve their safety record.
    Finally, the commenter requested we clarify whether all countries
for which a classification society is an RO must be a signatory to each
of the SOLAS, MARPOL, and ICLL conventions. The commenter was concerned
because classification societies usually are ROs of many countries,
including ones that have not ratified some of the international
conventions. In response, we point out that the regulatory text in
Sec.  2.45-15(a)(4) clearly states that the classification society must
have received approval to act as an RO by at least one country that is
a signatory to the SOLAS, MARPOL, and ICLL conventions. Therefore, at
least one country would have to be a signatory to these conventions.

B. Changes Made To Address the 2010 Act

    In this final rule, we made changes to several sections from the
proposed rule based on changes in applicability as required by the
enactment of the 2010 Act, which amended 46 U.S.C. 3316(c), and to
improve clarity and ensure accuracy of the information presented in
this final rule.
    We amended Sec. Sec.  2.45-10(a), 2.45-15(a), and 2.45-30 by
deleting any references to exemptions for IACS members in accordance
with the 2010

Act, which requires all classification societies, without exemption, to
seek Coast Guard approval prior to working on a vessel located in the
United States.
    We amended Sec.  2.45-25 by adding new paragraph (c), which states
that an application submitted to become a Coast Guard-RO under 46 CFR
part 8, subpart B satisfies the application requirements to become an
approved classification society as long as the RO's status has not been
revoked, it submits a request to become an approved classification
society, and it certifies that the application information submitted
under 46 CFR part 8, subpart B remains valid. This change, in response
to commenters seeking an exemption or automatic approval based on RO
status, avoids requiring organizations to resubmit information they
have previously provided as part of an application under 46 CFR part 8,
subpart B. This change permits such organizations to submit a minimal
application, as long as the Coast Guard has the necessary information
evidenced by continuing RO status and the certification that the
previously submitted information is still valid.
    We amended Sec.  2.45-15(a)(1) to clarify we will review the
detention records of a classification society for vessels it surveys
during the past 3 years.
    We also amended Sec.  2.45-15(a)(5) to clarify that the country for
which the classification society is an RO refers to the same country
referenced in Sec.  2.45-15(a)(4).
    We amended Sec.  2.45-15(a)(5)(ii) by rewording the language of the
proposed text to clarify that the one country for which the class
society meets the requirement of Sec.  2.45-15(a)(4) cannot be
identified as a flag state targeted for additional port state control
action by the Coast Guard.
    We also made minor changes to the regulatory text. First, the final
rule deletes the authority citation for 46 CFR 2.45, as this section
was removed from the CFR on September 30, 1997. See 62 FR 51195.
Second, the final rule makes minor formatting changes to improve
clarity, such as adding paragraph designations within some sections.
Finally, throughout the rule we changed the Coast Guard office
designator ``CG-521'' to CG-ENG'' to reflect a recent Coast Guard
organizational change.

VI. Incorporation by Reference

    The Director of the Federal Register has approved the material in
Sec.  2.45-5 for incorporation by reference under 5 U.S.C. 552 and 1
CFR part 51. Copies of the material are available from the sources
listed in that section.

VII. Regulatory Analyses

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

A. Regulatory Planning and Review

    This rule is not a significant regulatory action under section 3(f)
of Executive Order 12866, as amended by Executive Order 13563,
Regulatory Planning and Review, and does not require an assessment of
potential costs and benefits under section 6(a)(3) of that Order.
Accordingly, the Office of Management and Budget (OMB) has not reviewed
it under that Order.
    As previously discussed in section ``V. Discussion of Comments and
Changes,'' the applicability provision was changed to reflect an
amendment to the legal authority made by the Coast Guard
Reauthorization Act of 2010. In summary, the total cost for this rule
will involve only one-time costs for applications for the initial
approval, and we estimate the total will be $5,429. Below, we present
the basis for our estimate of the costs for this final rule that
accounts for this amendment and the current status of classification
societies active in the United States.
    We previously approved six classification societies under the
policy announced in 2004 based on the 2004 Act. Of the six, these two
are IACS members: Indian Register of Shipping and Polish Register of
Shipping. The other four that are not IACS members are: Bulgarian
Register of Shipping, China Corporation Register of Shipping, Hellenic
Register of Shipping, and International Naval Surveys Bureau. In the
NPRM, we stated that approved classification societies would not need
to take additional actions and would not occur any additional costs. We
are not aware of any information, either from the comments or other
sources, to alter that assessment. Thus, these six organizations would
not have any cost burden associated with this rulemaking.
    We identified the remaining members of IACS as the population
affected by the 2010 Act amendments, which changed the applicability of
46 U.S.C. 3316(c) to include IACS members in the application and review
procedures. Table 2 lists these classification societies and indicates
whether they currently have RO status with the Coast Guard under 46 CFR
part 8.

      Table 1--IACS Members Without Classification Society Approval
------------------------------------------------------------------------
          Class society                Abbreviation            RO?
------------------------------------------------------------------------
American Bureau of Shipping......  ABS.................  Yes.
Bureau Veritas...................  BV..................  Yes.
China Classification Society.....  CCS.................  No.
Croatian Register of Shipping....  CRS.................  No.
Det Norske Veritas...............  DNV.................  Yes.
Germanischer Lloyd...............  GL..................  Yes.
Korean Register of Shipping......  KRS.................  No.
Lloyd's Register of Shipping.....  LR..................  Yes.
Nippon Kaiji Kyokai..............  NK..................  Yes.
Registro Italiano Navale.........  RINA................  Yes.
Russian Maritime Register of       RS..................  No.
 Shipping.
------------------------------------------------------------------------

    As the table shows, there are seven class societies that are not
approved but currently have RO status (ABS, BV, DNV, GL, LR, NK, and
RINA). We assume that they will take advantage of Sec.  2.45-25(c) and
will submit an application to become approved classification societies.
    Coast Guard subject matter experts in the Naval Architecture
Division provided estimates of time to process one of these
applications submitted in accordance with new Sec.  2.45-25(c). The
classification society will require 1 hour for a junior manager to
draft the application letter and 0.5 hour for a senior manager to
review it. Coast Guard processing will require 2 hours for a senior
staff member or junior manager to review the application, verify the
data,

and draft the approval letter, and 0.25 hour for a senior manager to
review it. Table 2 presents the complete calculations of the unit cost
for this application, with the same wage rates used in the NPRM,
``Approval of Classification Societies'' (75 FR 21212).

                   Table 2--Unit Cost of Application for Classification Society With RO Status
----------------------------------------------------------------------------------------------------------------
            Sector                  Position           Hours        Wage  rate     Position cost   Sector  cost
----------------------------------------------------------------------------------------------------------------
Industry......................  Junior Manager..            1.00             $67             $67  ..............
                                Senior Manager..            0.50              88              44  ..............
                                                 ---------------------------------------------------------------
    Industry Total............  ................            1.50  ..............  ..............            $111
                                                 ---------------------------------------------------------------
Government....................  Junior Officer..            2.00              67             134  ..............
                                Senior Officer..            0.25              88              22  ..............
                                                 ---------------------------------------------------------------
    Government Total..........  ................            2.25  ..............  ..............             156
                                                 ---------------------------------------------------------------
        Total Unit Cost.......  ................            3.75  ..............  ..............             267
----------------------------------------------------------------------------------------------------------------

    The total cost for these applications is $1,869 and Table 3
displays the calculations.

      Table 3--Application Costs for Class Societies With RO Status
------------------------------------------------------------------------
                                                           Unit    Total
                     Sector                        Count   cost    cost
------------------------------------------------------------------------
Industry........................................       7    $111    $777
Government......................................       7     156   1,092
                                                 -----------------------
  Total.........................................       7     267   1,869
------------------------------------------------------------------------

    We anticipate that the other four classification societies that
currently are not ROs (CCS, CRS, KRS, and RS) will also apply to become
approved classification societies. They will need to prepare a complete
application per the requirements of Sec.  2.45-25(b). In the NPRM, we
estimated the total unit cost for one of these applications at $890
($712 for industry and $178 for government). We received no additional
information from either the comments or other sources to cause us to
modify this estimate. The total cost for these four applications is
$3,560, and Table 4 presents the calculations.

    Table 4--Application Costs for Class Societies Without RO Status
------------------------------------------------------------------------
                                                       Unit      Total
                   Sector                      Count   cost      cost
------------------------------------------------------------------------
Industry....................................       4    $712      $2,848
Government..................................       4     178         712
                                             ---------------------------
  Total.....................................       4     890       3,560
------------------------------------------------------------------------

    In the NPRM, we stated that based on the historical record, we
anticipate that the approved classification societies will remain in
good standing in the foreseeable future. We received no contrary
information since then. With that assumption, we anticipate that there
will be no costs associated with suspensions or reapprovals. As stated
earlier, we also anticipate that only current IACS members will apply
for approval.
    With these assumptions, the total costs for this rule will involve
only one-time costs for applications for the initial approval, and we
estimate the total will be $5,429. Table 5 summarizes these application
costs, as previously described.

                                        Table 5--Total Application Costs
----------------------------------------------------------------------------------------------------------------
                                                                     Industry       Government
                    RO Status                          Count           costs           costs       Total  costs
----------------------------------------------------------------------------------------------------------------
Currently RO....................................               7            $777          $1,092          $1,869
Not RO..........................................               4           2,848             712           3,560
                                                 ---------------------------------------------------------------
  Total.........................................              11           3,625           1,804           5,429
----------------------------------------------------------------------------------------------------------------

    The benefits of this rule derive from incorporating the amendments
from the Coast Guard Authorization Act of 2004 and the Coast Guard
Authorization Act of 2010 and incorporating the standards from IMO
Resolution A.739(18), ``Guidelines for the Authorization of
Organizations Acting on Behalf of the Administration,'' to provide a
sound and internationally recognized standard on which to base our
review and approval program.

B. Small Entities

    Under the Regulatory Flexibility Act (5 U.S.C. 601-612), we have
considered whether this rule would have a significant economic impact
on a substantial number of small entities. The term ``small entities''
comprises small businesses, not-for-profit organizations that are
independently owned and operated and are not dominant in their fields,
and governmental jurisdictions with populations of less than 50,000.
    For-profit classification societies affected by this rule may be
classified under one of the following North American Industry
Classification System (NAICS) 6-digit codes for water transportation:
488330--Navigation Services to Shipping or 488390--Other Support
Activities for Water Transportation. According to the Small Business
Administration's (SBA) size standards, a U.S. company classified under
these NAICS codes with annual revenues of less than $7 million is
considered a small entity.
    The only predominant U.S. classification society is the American
Bureau of Shipping (ABS), which is a non-profit organization. We do not
consider the ABS to be a small entity under the Regulatory Flexibility
Act. In addition, the costs that we described in the previous section
are so minimal, we

do not believe they rise to the level of being a significant economic
impact. Therefore, the Coast Guard certifies under 5 U.S.C. 605(b) that
this rule will not have a significant economic impact on a substantial
number of small entities.

C. Assistance for Small Entities

    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104-121), we offered to assist small
entities in understanding the rule so that they could better evaluate
its effects on them and participate in the rulemaking. The Coast Guard
will not retaliate against small entities that question or complain
about this rule or any policy or action of the Coast Guard.
    Small businesses may send comments on the actions of Federal
employees who enforce, or otherwise determine compliance with, Federal
regulations to the Small Business and Agriculture Regulatory
Enforcement Ombudsman and the Regional Small Business Regulatory
Fairness Boards. The Ombudsman evaluates these actions annually and
rates each agency's responsiveness to small business. If you wish to
comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR
(1-888-734-3247).

D. Collection of Information

    This rule calls for no new collection of information under the
Paperwork Reduction Act (PRA) of 1995 (44 U.S.C. 3501-3520).
    This rule comprises application procedures classification societies
must meet for approval. As stated in Section VII.A, we expect four new
approvals in the first year after the rule becomes effective. In the
NPRM, we forecasted that there would be no or very few applications in
the near future. We received no comments or additional information to
indicate that there would be 10 or more approvals after the first year.
Thus, we expect to receive less than 10 approval requests per year.
This figure is less than the threshold of 10 per 12-month period for
collection of information reporting purposes under the PRA.
    This rule specifies a separate approval process for classification
societies that are currently ROs. These ROs will only need to send the
Coast Guard a letter requesting that we use previously collected data
as the basis for their approval.
    As stated in Section VII.A, we expect the seven current ROs to use
this method to apply for approval the first year the rule becomes
effective. This process does not require any new information and the
affected population is less than the threshold of 10 per 12-month
period for collection of information reporting purposes under the PRA.

E. Federalism

    A rule has implications for federalism under Executive Order 13132,
Federalism, if it has a substantial direct effect on the States, on the
relationship between the national government and the States, or on the
distribution of power and responsibilities among the various levels of
government. We have analyzed this rule under that Order and have
determined that it does not have implications for federalism.

F. Unfunded Mandates Reform Act

    The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538)
requires Federal agencies to assess the effects of their discretionary
regulatory actions. In particular, the Act addresses actions that may
result in the expenditure by a State, local, or tribal government, in
the aggregate, or by the private sector of $100,000,000 (adjusted for
inflation) or more in any one year. Although this rule will not result
in such an expenditure, we do discuss the effects of this rule
elsewhere in this preamble.

G. Taking of Private Property

    This rule will not cause a taking of private property or otherwise
have taking implications under Executive Order 12630, Governmental
Actions and Interference with Constitutionally Protected Property
Rights.

H. Civil Justice Reform

    This rule meets applicable standards in sections 3(a) and 3(b)(2)
of Executive Order 12988, Civil Justice Reform, to minimize litigation,
eliminate ambiguity, and reduce burden.

I. Protection of Children

    We have analyzed this rule under Executive Order 13045, Protection
of Children from Environmental Health Risks and Safety Risks. This rule
is not an economically significant rule and does not create an
environmental risk to health or risk to safety that may
disproportionately affect children.

J. Indian Tribal Governments

    This rule does not have tribal implications under Executive Order
13175, Consultation and Coordination with Indian Tribal Governments,
because it does not have a substantial direct effect on one or more
Indian tribes, on the relationship between the Federal Government and
Indian tribes, or on the distribution of power and responsibilities
between the Federal Government and Indian tribes.

K. Energy Effects

    We have analyzed this rule under Executive Order 13211, Actions
Concerning Regulations That Significantly Affect Energy Supply,
Distribution, or Use. We have determined that it is not a ``significant
energy action'' under that order because it is not a ``significant
regulatory action'' under Executive Order 12866 and is not likely to
have a significant adverse effect on the supply, distribution, or use
of energy. The Administrator of the Office of Information and
Regulatory Affairs has not designated it as a significant energy
action. Therefore, it does not require a Statement of Energy Effects
under Executive Order 13211.

L. Technical Standards

    The National Technology Transfer and Advancement Act (NTTAA) (15
U.S.C. 272 note) directs agencies to use voluntary consensus standards
in their regulatory activities unless the agency provides Congress,
through the Office of Management and Budget, with an explanation of why
using these standards would be inconsistent with applicable law or
otherwise impractical. Voluntary consensus standards are technical
standards (e.g., specifications of materials, performance, design, or
operation; test methods; sampling procedures; and related management
systems practices) that are developed or adopted by voluntary consensus
standards bodies.
    This rule uses the following voluntary consensus standards: IMO
Resolution A.739(18), ``Guidelines for the Authorization of
Organizations Acting on Behalf of the Administration.'' The section
that references this standard and the location where this standard is
available is listed in 46 CFR 2.45-5.

M. Environment

    We have analyzed this rule under Department of Homeland Security
Management Directive 023-01 and Commandant Instruction M16475.lD, which
guide the Coast Guard in complying with the National Environmental
Policy Act of 1969 (NEPA) (42 U.S.C. 4321-4370f), and have concluded
that this action is one of a category of actions that do not
individually or cumulatively have a significant effect on the human
environment. This rule is categorically excluded under section 2.B.2,
figure 2-1, paragraphs (34)(b) and (d) of the Instruction. This rule
involves regulations concerning internal agency functions and
regulations concerning

manning, documentation, admeasurement, inspection, and equipping of
vessels. An environmental analysis checklist and a categorical
exclusion determination are available in the docket where indicated
under ADDRESSES.

List of Subjects in 46 CFR Part 2

    Incorporation by reference, Marine safety, Reporting and
recordkeeping requirements, Vessels.

    For the reasons discussed in the preamble, the Coast Guard amends
46 CFR part 2 as follows:

PART 2--VESSEL INSPECTIONS

0
1. The authority citation for part 2 is revised to read as follows:

    Authority:  Sec. 622, Pub. L. 111-281; 33 U.S.C. 1903; 43 U.S.C.
1333; 46 U.S.C. 2110, 3103, 3205, 3306, 3307, 3703; 46 U.S.C.
Chapter 701; E.O. 12234, 45 FR 58801, 3 CFR, 1980 Comp., p. 277;
Department of Homeland Security Delegation No. 0170.1.

0
2. Add subpart 2.45 to read as follows:
Subpart 2.45--Classification Society Activities
Sec.
2.45-1 Definitions.
2.45-5 Incorporation by reference.
2.45-10 General.
2.45-15 Approval requirements.
2.45-20 Probation, suspension, and revocation.
2.45-25 Application for approval.
2.45-30 Penalties.

Subpart 2.45--Classification Society Activities

Sec.  2.45-1  Definitions.

    The following definitions apply to this subpart:
    Administration means the Government of the State whose flag the
ship is entitled to fly.
    Classification society means an organization that, at a minimum,
verifies that a vessel meets requirements embodying the technical
rules, regulations, standards, guidelines and associated surveys, and
inspections covering the design, construction, and/or through life
compliance of a ship's structure and essential engineering and
electrical systems.
    Recognized Organization (RO) means an organization authorized to
act on behalf of an Administration.
    Regional port state control secretariat means an organization
established to collect and maintain port state control inspection data
in addition to other functions under a regional agreement among
countries.

Sec.  2.45-5  Incorporation by reference.

    (a) Certain material is incorporated by reference into this part
with the approval of the Director of the Federal Register under 5
U.S.C. 552(a) and 1 CFR part 51. To enforce any edition other than that
specified in this section, the Coast Guard must publish notice of
change in the Federal Register and the material must be available to
the public. All approved material is available for inspection at the
National Archives and Records Administration (NARA). For information on
the availability of this material at NARA, call<PHONE_NUMBER> or go to
http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html. Also, it is available for inspection
at the Coast Guard's Office of Design and Engineering Systems (CG-ENG),
2100 Second Street SW., Washington, DC 20593-0001, and is available
from the sources indicated in this section.
    (b) International Maritime Organization, 4 Albert Embankment,
London SE1 7SR, U.K. +44 (0)20 7735 7611, http://www.imo.org/.
    (1) IMO Resolution A.739(18), Guidelines for the Authorization of
Organizations Acting on Behalf of the Administration, adopted 4
November 1993, incorporation by reference approved for Sec.  2.45-15.
    (2) [Reserved]

Sec.  2.45-10  General.

    (a) A classification society (including an employee or agent of
that society) must not review, examine, survey, or certify the
construction, repair, or alteration of a vessel in the United States
unless it is approved under the provisions of this subpart.
    (b) This subpart applies to a recognized organization that meets
the definition of a classification society provided in Sec.  2.45-1 of
this subpart.

Sec.  2.45-15  Approval requirements.

    (a) A classification society may be approved for purpose of Sec.
2.45-10 if the following conditions are met:
    (1) Vessels surveyed by the classification society must have a
worldwide port state control detention rate of less than 2 percent
based on the number of Recognized Organization (RO)-related detentions
divided by the number of vessel inspections for at least 40 port state
control inspections for the past 3 years;
    (2) The classification society must not be identified in the most
recent publication of ``Port State Control in the United States'' as a
Priority I and as having more than one RO-related detention for the
past 3 years;
    (3) The classification society must comply with the minimum
standards for an RO recommended in IMO Resolution A.739(18), Appendix 1
(incorporated by reference, see Sec.  2.45-5.);
    (4) The classification society must be an RO for at least one
country under a formal written agreement that includes all of the
elements described in IMO Resolution A.739(18), Appendix 2
(incorporated by reference, see Sec.  2.45-5.);
    (5) The referenced country that is cited for satisfaction of the
requirement of paragraph (a)(4) of this section for which the
classification society is an RO--
    (i) Must be signatory to each of the following: The International
Safety of Life at Sea Convention (SOLAS), the International Convention
on the Prevention of Pollution from Ships (MARPOL 73/78), the
International Convention on Load Lines (ICLL), 1966, and the Protocol
of 1988 relating to the ICLL, 1966; and
    (ii) Must not be identified as a flag state targeted for additional
port state control action by the Coast Guard or any regional port state
control secretariat.
    (6) The classification society must use a system to--
    (i) Make its safety records and those of persons acting on behalf
of the classification society available to the Coast Guard in
electronic format;
    (ii) Provide its safety records and those of persons acting on
behalf of the classification society to another classification society
that requests those records for the purpose of conducting surveys of
vessels; and
    (iii) Request the safety records of a vessel to be surveyed from
any other classification society that previously surveyed that vessel.
    (b) Where sufficient performance records are not available from a
regional port state control secretariat, the Coast Guard may consider
an equivalent safety performance indicator proposed by the
classification society seeking approval.

Sec.  2.45-20  Probation, suspension, and revocation.

    (a) A classification society approved for the purpose of this
subpart must maintain the minimum requirements for approval set forth
in Sec.  2.45-15.
    (b) If an approved classification society fails to maintain
compliance with paragraph (a) of this section, the Coast Guard may
place the classification society approval on probation, or suspend or
revoke the classification society's approval, as appropriate.
    (c) Probation. A classification society on probation is approved
for the

purpose of this subpart. The probation continues until the next review
of the classification society's compliance with paragraph (a) of this
section.
    (1) If the review shows that compliance with paragraph (a) of this
section is achieved, the probation may end.
    (2) If the review shows significant improvement but compliance with
paragraph (a) of this section is not achieved, the probation may be
extended.
    (3) If the review does not show significant improvement, and
compliance with paragraph (a) of this section is not achieved, the
approval may be suspended.
    (d) Suspension. A classification society whose approval is
suspended is not approved for the purpose of this subpart. Suspension
will continue until the next review of the classification society's
compliance with paragraph (a) of this section.
    (1) If the review shows compliance with paragraph (a) of this
section, the classification society's approval may be restored.
    (2) If the review shows significant improvement toward compliance
with paragraph (a) of this section, the suspension may be extended.
    (3) If the review does not show significant improvement and
compliance with paragraph (a) of this section, the classification
society's approval may be revoked.
    (e) Revocation. A classification society whose approval is revoked
is not approved for the purpose of this subpart. The classification
society may reapply for approval when the requirements of Sec.  2.45-15
are met.
    (f) The Coast Guard's Office of Design and Engineering Standards
(CG-ENG) administers probations, suspensions, and revocations and makes
all related notifications to affected classification societies.

Sec.  2.45-25  Application for approval.

    (a) An application for approval must be made in writing and in the
English language to U.S. Coast Guard, Commandant (CG-ENG), Office of
Design and Engineering Standards, 2100 Second Street SW. Stop 7126,
Washington DC 20593-7126.
    (b) The application must--
    (1) Indicate the type of work the classification society intends to
perform on vessels in the United States;
    (2) Include documentation demonstrating that the classification
society complies with Sec.  2.45-15;
    (3) Contain a list of the vessels surveyed by the classification
society over the previous 3 calendar years. The list must include
vessel names, flags, and IMO numbers, as well as initial vessel
inspections and detentions; and
    (4) Provide a summary of the safety records of vessels the
classification society surveys for each of the previous 3 calendar
years, including initial vessel inspections and detentions for all data
contained in regional port state control Memoranda of Understanding
(MOU) and other port state control data sources, including the U.S.
Coast Guard.
    (c) An application submitted in accordance with 46 CFR part 8,
subpart B satisfies the application requirements of paragraph (a) of
this section, provided the applicant:
    (1) Has been notified in writing by the Commandant that it met the
criteria to be a recognized classification society, and its recognized
status has not been revoked, under 46 CFR part 8, subpart B;
    (2) Submits in writing and in the English language to the address
in paragraph (a) of this section a statement that the applicant is
applying for approval under this subpart; and
    (3) Certifies in the submission under paragraph (c)(2) of this
section that the information in the application submitted under 46 CFR
part 8, subpart B remains valid.

Sec.  2.45-30  Penalties.

    The owner, charterer, managing operator, agent, master, or
individual in charge of a vessel that employs a classification society
to review, examine, survey, or certify the construction, repair, or
alteration of a vessel in the United States is subject to civil
penalties in accordance with Title 46 U.S.C. 3318 if the classification
society is not approved by the Coast Guard under this subpart.

    Dated: July 26, 2012.
J.G. Lantz,
Director of Commercial Regulations and Standards, U. S. Coast Guard.
[FR Doc. 2012-19376 Filed 8-8-12; 8:45 am]
BILLING CODE 9110-04-P


Rich To: pvoytek@ crosslink. net Leukroth/ DC/ USEPAIU cc: Rob Dewoskin/ RTP/ USEPA'US © EPA, Michel S@ EPA Stevens/ RTP/ USEPNUS@ EPA, Paul CampanellalDC/ USEPA/ US © EPA John 02/ 28/ 2003 10: 38 AM Schaeffer/ DC/ USEPA/ US © EPA Subject: TOE Technical Oonsult Mtg EPA requests a technical consultation meeting with the HAP Task Force to discuss progress on the Tier I Program Review for the l, l, 2~ trichloroethane ( TOE) enforceable consent agreement ( ECA) . Since most of the scientist involved will be attending the Society of Toxicology ( SOT) meeting in Salt Lake, UT I suggest that we could meet on Wednesday, March 12th following the last afternoon SOT session ( 4: 30  6: 00 pm).

Attached is a tentative agenda, overview of the EPA preliminary findings, and a discription of discussion topics relevant to the TCE alternative testing program.

Please let me know if this is acceptable to the HAP Task Force and who D will be attending the meeting. 3l2O3TCEJCmtgAgenda. wpd OPPT 2002 0056 0064 RECEIVED OPPT NCIC 2003 JUN24 8: 05AM Technical Consultation Meeting on 1,1,2 Trichloroethane ( TCE) EPA Tier I Program Review Update DATE / TIME: February 12, 2003 4: 30p. m.  6: 00p. m.

LOCATION:

PURPOSE: Society of Toxicology Meeting, Salt Lake City, UT EPA will describe preliminary findings on the Tier I Program Review activity for 1,1, 2 trichioroethane and engage in scientistto scientist discussions with the HAP Task Force on clarifying questions and the nature and scope of Tier II testing under the Enforceable Consent Agreement for 1,1 ,2 Trichloroethane.

I. Introductions TENTATIVE AGENDA Rich Leukroth / Peter Voytek II. Overview of the ORD Program Review Activity III. Discussion Topics Rob Dewoskin ( see attachment)

IV. Next Steps Meeting Handout February 12, 2003 Technical Consultation Meeting for 1,1,2 Trichioroethane Tier I Program Review Overview ofORD Preliminary Findings EPA's Tier I Program Review for 1,1,2 trichioroethane ( TCE) is focused on four reports submitted by the HAP Task Force in accordance with the Enforceable Consent Agreement ( ECA) for TCE. The on going Program Review notes that the PKIMECH data and Tier I toxicity studies appear to have been conducted in accordance with the protocols and specifications as described in the ECA. The available study records are sufficient to allow an evaluation ofthe quality ofthe studies and the data. The TCE PBPK model is chemical specific, and is based on the current understanding of the kinetics ofTCE. The species, dose level, exposure regimens, and vehicles used are relevant for the toxicity data that are the object of the Tier II extrapolations. The Tier I Program Review PK! MECH data demonstrated that periodicity was achieved in the studies that support the model. The EPA preliminary review identified five topics for discussion at a technical consultation meeting with the HAP Task Force.

Technical Consultation Discussion Topics 1) Characterizing variability and uncertainty in the kinetic data and the model simulations EPA Preliminary Finding: An acceptable PBPK model report must include adequate discussion of the variability in the kinetic data used to develop the model, and the variability and uncertainty in the model with respect to the " fit" of the simulations to the kinetic data. A more thorough discussion is needed to support scientifically defensible arguments for use ofthe PBPK model in each of the proposed route to route extrapolation. Examples of criteria for characterizing " fit" include percent match for AUC, or simulation curves that fall within ± " x" number of standard deviations of the mean.

Preliminary Recommendation: The HAP Task Force can provide this information as an addendum to their report.

1 Meeting Handout February 12, 2003 2) Quality review of the pharmacokinetic and PBPK data and reports.

EPA Preliminary Finding: Overall, PK, and PBPK modeling studies submitted by the HAP Task Force under this ECA appear to have been well conducted with excellent documentation. However, EPA's preliminary review of the study records identified a few reporting errors. For example: a) in the PK report, Table B 2, 30 mm andi hour reported average dose values appear to be incorrect; and b) in the PBPK model parameters there is an apparent difference between the value reported in the PK report for the spleen : air partition coefficient ( page 43) and the value used in the PBPK model ( page 53).

Part VIII. D. of the ECA agreement states that " all testing required by this ECA shall be conducted in accordance with the EPA Good Laboaratory Practice ( GLP) Standards contained in 40 CFR part 792. EPA does not have specific GLP guidelines available for pharmacokinetic ( PK) and PBPK model studies. Some of the GLP requirements ( e. g., retention of records) are also not applicable to this work. Nonetheless, the GLPs provide for noncompliance with specific requirements as long as a statement ( signed by the sponsor and study director) describing the differences between the practices used in the study and those required by part 792 is included in the submission ( see 792.12  Statement of compliance or non compliance).

Preliminary Recommendation: To ensure the quality of the PK and PBPK model data and reports submitted to EPA, the data records and reports should undergo a quality assurance review. A signed QA statement documenting the review as well as a signed GLP compliance statement should be appended to the report.

3a) Choice of dose metrics and dosing regimens EPA Preliminary Finding: The PBPK model report provides a good example ofthe potential use ofthe model for a route to route extrapolation, in this case, for a drinking water exposure to an inhalation exposure using amount metabolized as the dose metric. Views that additional examples of study specific route to route extrapolation curves are needed to adequately review how the PBPK model will perform for the specific studies and dose metrics called for in the Tier II route to route extrapolations. The utility of the model for each application depends, in part, on the choice of the dose metric and the dose regimen used in the simulation ( e. g., the dose pattern used to simulate a drinking water exposure). Such route toroute extrapolation curves could readily be developed specific to each of the extant Tier II studies for which extant data is available ( immunotoxicity and carcinogenicity). These curves will provide comparisons among different dose metrics and exposure patterns, and will support a more scientifically defensible evaluation of the utility of the PBPK model for each application. Meeting Handout February 12, 2003 3a) Continued Preliminary Recommendation: The HAP Task Force is encouraged to proceed with these reporting activities as a means to further support the TCE model even though they are listed as Tier II ECA activities.

3b) EPA notes that similar route to route extrapolation curves could also be generated based for the dose regimens of the new Tier II studies ( neuro, developmental, and reproductive toxicity) prior to the conduct of the studies. Such simulations could include considerations for different dose metrics. Based upon the results of the Tier I Program Review Testing, simulation runs prior to the conduct of the new Tier II studies could lead to further improvements in the model and the study protocols.

Preliminary Recommendation: ( discussion at the technical consultation meeting)

4) Support for inclusion of suicide inhibition in the model EPA Preliminary Finding: The HAP Task Force has incorporated a suicide enzyme inhibition component into the PBPK model as a means to explain why the model, as originally conceived, could not predict differences observed between female and male mice. The PBPK report lacks adequate data to support this hypothesis.

Preliminary Recommendation: The hypothesis of suicide enzyme inhibition in female mice ( and not in male mice) needs additional support. A study to consider would be an in vitro microsomal assay for P450 inhibition.

5a) Route specific considerations of the nasal toxicity observed in the inhalation studies for toxicity.

EPA Preliminary Finding: EPA notes that the nasal toxicity observed in the inhalation studies performed under Tier I testing may not be adequately addressed for route specific toxicity. The relevance of the olfactory cytotoxicity to humans needs to be discussed, as well as the impact that nasal toxicity might have on study outcomes for the endpoints of interest in Tier II, in contrast to an oral exposure without nasal toxicity.

Preliminary Recommendation: ( discussion at the technical consultation meeting)

3 Meeting Handout February 12, 2003 Sb) Route specific considerations of the nasal toxicity observed in the inhalation studies on the kinetics.

EPA Preliminaiy Finding: The nasal toxicity may not be adequately addressed for route specific effects on the kinetics including first pass effects and delivery of parent compound to the brain compartment ( i. e., peak concentrations or time above a given concentration). First pass effects can be evaluated using the model ( i. e., comparison of bioavailability for different exposure routes).

Preliminary Recommendation: ( discussion at the technical consultation meeting)

4


Memo to File

From:  Ryan Albert
Date:  6/20/12

On June 20, 2012 EPA attended a listening session with a representative from the Canadian Ship Owners Association (CSA).

Attendees are the following:

Name			Affiliation
Bruce Bowie		CSA
Ryan Albert		EPA
Kathryn Kelley	EPA

The following topics were raised by the representative from CSA:

 The feasibility of ballast water treatment for CSA vessels.
 The designation of "Confined Lakers."
 The availability of technology and type approval process for ballast water treatment.
 Coordination between EPA and the U.S. Coast Guard on dates for implementation.


[Federal Register: November 21, 2008 (Volume 73, Number 226)]
[Notices]
[Page 70696-70697]
[DOCID:fr21no08-112]

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DEPARTMENT OF TRANSPORTATION

Pipeline and Hazardous Materials Safety Administration

Office of Hazardous Materials Safety; Notice of Application for
Special Permits

AGENCY: Pipeline and Hazardous Materials Safety Administration (PHMSA),
DOT.

ACTION: List of Applications for Special Permits.

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SUMMARY: In accordance with the procedures governing the application
for, and the processing of, special permits from the Department of
Transportation's Hazardous Material Regulations (49 CFR Part 107,
Subpart B), notice is hereby given that the Office of Hazardous
Materials Safety has received the application described herein. Each
mode of transportation for which a particular special permit is
requested is indicated by a number in the ``Nature of Application''
portion of the table below as follows: 1--Motor vehicle, 2--Rail
freight, 3--Cargo vessel, 4--Cargo aircraft only, 5--Passenger-carrying
aircraft.

DATES: Comments must be received on or before December 22, 2008.
    Address Comments to: Record Center, Pipeline and Hazardous
Materials Safety Administration, U.S. Department of Transportation,
Washington, DC 20590.
    Comments should refer to the application number and be submitted in
triplicate. If confirmation of receipt of comments is desired, include
a self-addressed stamped postcard showing the special permit number.

FOR FURTHER INFORMATION CONTACT: Copies of the applications are
available for inspection in the Records Center, East Building, PHH-30,
1200 New Jersey Avenue, Southeast, Washington DC or at http://
dms.dot.gov.
    This notice of receipt of applications for special permit is
published in accordance with Part 107 of the Federal hazardous
materials transportation law (49 U.S.C. 5117(b); 49 CFR 1.53(b)).

    Issued in Washington, DC on November 10 2008.
Delmer F. Billings,
Director, Office of Hazardous Materials, Special Permits and Approvals.

                                               New Special Permits
----------------------------------------------------------------------------------------------------------------
                                                                        Regulation(s)        Nature of special
        Application No.            Docket No.         Applicant            affected           permits thereof
----------------------------------------------------------------------------------------------------------------
14782-N.......................  ................  Southern States,  49 CFR 173.304a......  To authorize the
                                                   LLC, Atlanta,                            transportation in
                                                   GA.                                      commerce of large
                                                                                pieces of electrical
                                                                                equipment containing
                                                                                a chamber which
                                                                                holds sulfur
                                                                                hexafluoride in
                                                                                alternative
                                                                                packaging. (modes 1,
                                                                                2, 3).
14784-N.......................  ................  Weldship          49 CFR 180.209(a) and  To authorize the
                                                   Corporation,      (b).                   requalification of
                                                   Bethlehem, PA.                           certain DOT-
                                                                                Specification
                                                                                Cylinders containing
                                                                                Division 2.1 and 2.2
                                                                                gases every ten
                                                                                years. (modes 1, 2,
                                                                                3).

14786-N.......................  ................  Fruit of the      49 CFR                 To authorize the
                                                   Earth, Inc.,      173.306(a)(3)(v).      transportation in
                                                   Fort Worth, TX.                          commerce of certain
                                                                                non-refillable
                                                                                aluminum cylindrical
                                                                                containers that are
                                                                                leak tested by an
                                                                                automated in-line
                                                                                pressure check in
                                                                                lieu of the required
                                                                                hot water bath.
                                                                                (modes 1, 2, 3, 4,
                                                                                5).
14787-N.......................  ................  Flexcon           49 CFR 173.306(g)....  To authorize the
                                                   Industries,                              transportation in
                                                   Randolph, MA.                            commerce of certain
                                                                                fiber reinforced
                                                                                plastic composite
                                                                                cylinders containing
                                                                                compressed air under
                                                                                the exception in 49
                                                                                CFR 173.306(g).
                                                                                (modes 1, 2, 3).
14789-N.......................  ................  Blasting          49 CFR 177.835(g)....  To authorize the
                                                   Solutions,                               transportation in
                                                   Inc., Syracuse,                          commerce of certain
                                                   UT.                                      detonator assemblies
                                                                                on the same motor
                                                                                vehicle with any
                                                                                other Class I
                                                                                explosives when they
                                                                                are in separate and
                                                                                isolated cargo-
                                                                                carrying
                                                                                compartments powered
                                                                                by the same tractor,
                                                                                (mode 1).
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 [FR Doc. E8-27595 Filed 11-20-08; 8:45 am]

BILLING CODE 4910-60-M