[Federal Register: October 15, 2009 (Volume 74, Number 198)]
[Notices]
[Page 52961]
[DOCID:fr15oc09-51]

-----------------------------------------------------------------------

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. PR09-33-000]

Kinder Morgan Border Pipeline LLC; Notice of Petition for Rate
Approval

October 7, 2009.
    Take notice that on September 29, 2009, Kinder Morgan Border
Pipeline LLC (KM Border) filed a petition for rate approval pursuant to
section 284.123(b)(2) of the Commission's regulation. KM Border
requests the Commission to approve the continuation of its existing
rates, which are: (1) A two part maximum firm transportation rate for
service on its Import/Export Facility consisting of a demand charge of
$2.2381 per MMBtu of reserved Maximum Daily Transportation Quantity,
and a commodity charge of $0.00 per MMBtu of gas transported; (2) a
maximum interruptible rate of $0.0736 per MMBtu of gas transported on
its Import/Export Facility; (3) a two-part maximum firm transportation
rate for service on capacity leased from other intrastate pipelines
consisting of a demand a charge $1.5208 per MMBtu of reserved Maximum
Daily Transportation Quantity and a commodity charge of $0.00 per MMBtu
of gas transported; and (4) a maximum interruptible rate of $0.05 per
MMBtu of gas transported on such leased capacity.
    KM Border further proposes to continue to retain as reimbursement
for compressor fuel varying amounts ranging from 0.57 percent to 1.55
percent, depending on the Points of Redelivery used. KM Border states
that the foregoing existing zone rates will, if approved by the
Commission, be applicable to firm and interruptible transportation
services provided by KM Border pursuant to section 311(a)(2) of the
Natural Gas Policy Act through the pipeline owned and operated by KM
Border (The Import/Export Facility), and through pipeline capacity
leased by KM Border (The Leased Capacity).
    The Import/Export Facility consist of approximately 97 mile of 24-
inch pipeline that extends from a point of interconnection in Hidalgo
County, Texas, with the pipeline facilities of PEMEX Gas and
Petroquimica Basica at the International Border between the United
States and Mexico to a point of interconnection with the intrastate
pipeline facilities of Kinder Morgan Tejas Pipeline LLC (KM Tejas)
located on the King Ranch, Kleberg County, Texas. The Leased Capacity
is capacity leased on the intrastate pipeline facilities of KM Tejas.
    Any person desiring to participate in this rate proceeding must
file a motion to intervene or to protest this filing must file in
accordance with Rules 211 and 214 of the Commission's Rules of Practice
and Procedure (18 CFR 385.211 and 385.214). Protests will be considered
by the Commission in determining the appropriate action to be taken,
but will not serve to make protestants parties to the proceeding. Any
person wishing to become a party must file a notice of intervention or
motion to intervene, as appropriate. Such notices, motions, or protests
must be filed on or before the date as indicated below. Anyone filing
an intervention or protest must serve a copy of that document on the
Applicant. Anyone filing an intervention or protest on or before the
intervention or protest date need not serve motions to intervene or
protests on persons other than the Applicant.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the ``eFiling'' link at http://
www.ferc.gov. Persons unable to file electronically should submit an
original and 14 copies of the protest or intervention to the Federal
Energy Regulatory Commission, 888 First Street, NE., Washington, DC
20426.
    This filing is accessible on-line at http://www.ferc.gov, using the
``eLibrary'' link and is available for review in the Commission's
Public Reference Room in Washington, DC. There is an ``eSubscription''
link on the Web site that enables subscribers to receive email
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please email
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For
TTY, call<PHONE_NUMBER>.
    Comment Date: 5 p.m. Eastern Time on Friday, October 16, 2009.

Kimberly D. Bose,
Secretary.
[FR Doc. E9-24798 Filed 10-14-09; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 77, Number 93 (Monday, May 14, 2012)]
[Proposed Rules]
[Pages 28343-28347]
[FR Doc No: 2012-11565]

=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF TRANSPORTATION

National Highway Traffic Safety Administration

49 CFR Part 544

[Docket No.: NHTSA-2012-0020]
RIN 2127-AL22

Insurer Reporting Requirements; List of Insurers Required To File
Reports

AGENCY: National Highway Traffic Safety Administration (NHTSA),
Department of Transportation (DOT).

ACTION: Notice of proposed rulemaking.

-----------------------------------------------------------------------

SUMMARY: This document proposes to amend appendices to NHTSA
regulations on Insurer Reporting Requirements. The appendices list
those passenger motor vehicle insurers that are required to file
reports on their motor vehicle theft loss experiences. An insurer
included in any of these appendices would be required to file three
copies of its report for the 2009 calendar year before October 25,
2012. If the passenger motor vehicle insurers remain listed, they must
submit reports by each subsequent October 25. We are proposing to add
and remove several insurers from relevant appendices.

DATES: Comments must be submitted not later than July 13, 2012.
Insurers listed in the appendices are required to submit reports on or
before October 25, 2012.

ADDRESSES: You may submit comments, identified by DOT Docket No. NHTSA-
2012-0020 by any of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov. Follow the online instructions for submitting
comments.
     Mail: Docket Management Facility: U.S. Department of
Transportation, 1200 New Jersey Avenue SE., West Building, Ground
Floor, Room W12-140, Washington, DC 20590-0001.
     Hand Delivery or Courier: West Building Ground Floor, Room
W12-140, 1200 New Jersey Avenue SE., Washington, DC, between 9 a.m. and
5 p.m. ET, Monday through Friday, except Federal holidays.
     Fax: 1-202-493-2251.
    Instructions: For detailed instructions on submitting comments and
additional information on the rulemaking process,

see the Public Participation heading of the Supplementary Information
section of this document. Note that all comments received will be
posted without change to http://www.regulations.gov, including any
personal information provided. Please see the Privacy Act heading
below.
    Privacy Act: Anyone is able to search the electronic form of all
comments received into any of our dockets by the name of the individual
submitting the comment (or signing the comment, if submitted on behalf
of an association, business, labor union, etc.). You may review DOT's
complete Privacy Act Statement in the Federal Register published on
April 11, 2000 (65 FR 19477-78) or you may visit http://DocketInfo.dot.gov.
    Docket: For access to the docket to read background documents or
comments received, go to the street address listed above. The internet
access to the docket will be at http://www.regulations.gov. Follow the
online instructions for accessing the dockets.

FOR FURTHER INFORMATION CONTACT: Carlita Ballard, Office of
International Policy, Fuel Economy and Consumer Programs, NHTSA, 1200
New Jersey Avenue SE., Washington, DC 20590, by electronic mail to
<EMAIL_ADDRESS>Ms. Ballard's telephone number is (202) 366-
0846. Her fax number is<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    Pursuant to 49 U.S.C. 33112, Insurer reports and information, NHTSA
requires certain passenger motor vehicle insurers to file an annual
report with the agency. Each insurer's report includes information
about thefts and recoveries of motor vehicles, the rating rules used by
the insurer to establish premiums for comprehensive coverage, the
actions taken by the insurer to reduce such premiums and the actions
taken by the insurer to reduce or deter theft. Under the agency's
regulation, 49 CFR part 544, the following insurers are subject to the
reporting requirements:
    (1) Issuers of motor vehicle insurance policies whose total
premiums account for 1 percent or more of the total premiums of motor
vehicle insurance issued within the United States;
    (2) Issuers of motor vehicle insurance policies whose premiums
account for 10 percent or more of total premiums written within any one
state; and
    (3) Rental and leasing companies with a fleet of 20 or more
vehicles not covered by theft insurance policies issued by insurers of
motor vehicles, other than any governmental entity.
    Pursuant to its statutory exemption authority, the agency exempted
certain passenger motor vehicle insurers from the reporting
requirements.

A. Small Insurers of Passenger Motor Vehicles

    Section 33112(f)(2) provides that the agency shall exempt small
insurers of passenger motor vehicles if NHTSA finds that such
exemptions will not significantly affect the validity or usefulness of
the information in the reports, either nationally or on a state-by-
state basis.
    The term ``small insurer'' is defined, in Section 33112(f)(1)(A)
and (B), as an insurer whose premiums for motor vehicle insurance
issued directly or through an affiliate, including pooling arrangements
established under state law or regulation for the issuance of motor
vehicle insurance, account for less than 1 percent of the total
premiums for all forms of motor vehicle insurance issued by insurers
within the United States. However, that section also stipulates that if
an insurance company satisfies this definition of a ``small insurer,''
but accounts for 10 percent or more of the total premiums for all motor
vehicle insurance issued in a particular state, the insurer must report
about its operations in that state.
    In the final rule establishing the insurer reports requirement (52
FR 59; January 2, 1987), 49 CFR Part 544, NHTSA exercised its exemption
authority by listing in Appendix A each insurer that must report
because it had at least 1 percent of the motor vehicle insurance
premiums nationally. Listing the insurers subject to reporting, instead
of each insurer exempted from reporting because it had less than 1
percent of the premiums nationally, is administratively simpler since
the former group is much smaller than the latter. In Appendix B, NHTSA
lists those insurers required to report for particular states because
each insurer had a 10 percent or greater market share of motor vehicle
premiums in those states. In the January 1987 final rule, the agency
stated that it would update Appendices A and B annually. NHTSA updates
the appendices based on data voluntarily provided by insurance
companies to A.M. Best.\1\ A.M. Best publishes in its State/Line Report
each spring. The agency uses the data to determine the insurers' market
shares nationally and in each state.
---------------------------------------------------------------------------

    \1\ A.M. Best Company is a well-recognized source of insurance
company ratings and information. 49 U.S.C. 33112(i) authorizes NHTSA
to consult with public and private organizations as necessary.
---------------------------------------------------------------------------

B. Self-Insured Rental and Leasing Companies

    In addition, upon making certain determinations, NHTSA grants
exemptions to self-insurers, i.e., any person who has a fleet of 20 or
more motor vehicles (other than any governmental entity) used for
rental or lease whose vehicles are not covered by theft insurance
policies issued by insurers of passenger motor vehicles, 49 U.S.C.
33112(b)(1) and (f). Under 49 U.S.C. 33112(e)(1) and (2), NHTSA may
exempt a self-insurer from reporting, if the agency determines:
    (1) The cost of preparing and furnishing such reports is excessive
in relation to the size of the business of the insurer; and 33112(e)(1)
and (2),
    (2) The insurer's report will not significantly contribute to
carrying out the purposes of Chapter 331.
    In a final rule published June 22, 1990 (55 FR 25606), the agency
granted a class exemption to all companies that rent or lease fewer
than 50,000 vehicles, because it believed that the largest companies'
reports sufficiently represent the theft experience of rental and
leasing companies. NHTSA concluded that smaller rental and leasing
companies' reports do not significantly contribute to carrying out
NHTSA's statutory obligations and that exempting such companies will
relieve an unnecessary burden on them. As a result of the June 1990
final rule, the agency added Appendix C, consisting of an annually
updated list of the self-insurers subject to Part 544. Following the
same approach as in Appendix A, NHTSA included, in Appendix C, each of
the self-insurers subject to reporting instead of the self-insurers
which are exempted.
    NHTSA updates Appendix C based primarily on information from
Automotive Fleet Magazine and Auto Rental News.\2\
---------------------------------------------------------------------------

    \2\ Automotive Fleet Magazine and Auto Rental News are
publications that provide information on the size of fleets and
market share of rental and leasing companies.
---------------------------------------------------------------------------

C. When a Listed Insurer Must File a Report

    Under Part 544, as long as an insurer is listed, it must file
reports on or before October 25 of each year. Thus, any insurer listed
in the appendices must file a report before October 25, and by each
succeeding October 25, absent an amendment removing the insurer's name
from the appendices.

II. Proposal

1. Insurers of Passenger Motor Vehicles

    Appendix A lists insurers that must report because each had 1
percent of the motor vehicle insurance premiums on a national basis.
The list was last amended in a final rule published on July 13, 2011
(76 FR 41138). Based on the 2009 calendar year data market shares from
A.M. Best, NHTSA proposes to remove American International Group from
Appendix A and add California State Auto Group to Appendix A.
    Each of the 17 insurers listed in Appendix A are required to file a
report before October 25, 2012, setting forth the information required
by Part 544 for each State in which it did business in the 2009
calendar year. As long as these 17 insurers remain listed, they will be
required to submit reports by each subsequent October 25 for the
calendar year ending slightly less than 3 years before.
    Appendix B lists insurers required to report for particular States
for calendar year 2009, because each insurer had a 10 percent or
greater market share of motor vehicle premiums in those States. Based
on the 2009 calendar year data for market shares from A.M. Best, we
propose to make no change to Appendix B.
    The eight remaining insurers listed in Appendix B are required to
report on their calendar year 2009 activities in every State where they
had a 10 percent or greater market share. These reports must be filed
by October 25, 2012, and set forth the information required by Part
544. As long as these eight insurers remain listed, they would be
required to submit reports on or before each subsequent October 25 for
the calendar year ending slightly less than 3 years before.

2. Rental and Leasing Companies

    Appendix C lists rental and leasing companies required to file
reports. NHTSA proposes to make no change to Appendix C.
    Each of the remaining five companies (including franchisees and
licensees) listed in Appendix C are required to file reports for
calendar year 2009 no later than October 25, 2012, and set forth the
information required by Part 544. As long as those five companies
remain listed, they would be required to submit reports before each
subsequent October 25 for the calendar year ending slightly less than 3
years before.

III. Regulatory Impacts

1. Costs and Other Impacts

    This notice has not been reviewed under Executive Order 12866.
NHTSA has considered the impact of this proposed rule and determined
that the action is not ``significant'' within the meaning of the
Department of Transportation's regulatory policies and procedures. This
proposed rule implements the agency's policy of ensuring that all
insurance companies that are statutorily eligible for exemption from
the insurer reporting requirements are in fact exempted from those
requirements. Only those companies that are not statutorily eligible
for an exemption are required to file reports.
    NHTSA does not believe that this proposed rule, reflecting current
data, affects the impacts described in the final regulatory evaluation
prepared for the final rule establishing Part 544 (52 FR 59; January 2,
1987). Accordingly, a separate regulatory evaluation has not been
prepared for this rulemaking action. The cost estimates in the 1987
final regulatory evaluation should be adjusted for inflation, using the
Bureau of Labor Statistics Consumer Price Index for 2012 (see http://www.bls.gov/cpi). The agency estimates that the cost of compliance is
$50,000 (1987 dollars) for any insurer added to Appendix A, $20,000
(1987 dollars) for any insurer added to Appendix B, and $5,770 (1987
dollars) for any insurer added to Appendix C. If this proposed rule is
made final, for Appendix A, the agency would propose to remove and add
one company, for Appendix B, the agency would propose to make no
change, and for Appendix C, the agency would propose to make no change.
The agency estimates that the net effect of this proposal, if made
final, would have no cost to insurers as a group.
    Interested persons may wish to examine the 1987 final regulatory
evaluation. Copies of that evaluation were placed in Docket No. T86-01;
Notice 2. Any interested person may obtain a copy of this evaluation by
writing to NHTSA, Technical Reference Division, 1201 New Jersey Avenue
SE., East Building, Ground Floor, Room E12-100, Washington, DC 20590,
or by calling<PHONE_NUMBER>.

2. Paperwork Reduction Act

    The information collection requirements in this proposed rule were
submitted to the Office of Management and Budget (OMB) pursuant to the
requirements of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.).
This collection of information is assigned OMB Control Number 2127-0547
(``Insurer Reporting Requirements''). This collection of information is
approved for use through April 30, 2015, and the agency will seek to
extend the approval afterwards. The existing information collection
indicates that the number of respondents for this collection is thirty,
however, the actual number of respondents fluctuate from year to year.
Therefore, because the number of respondents required to report for
this final rule does not exceed the number of respondents indicated in
the existing information collection, the agency does not believe that
an amendment to the existing information collection is necessary.

3. Regulatory Flexibility Act

    The agency also considered the effects of this rulemaking under the
Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq.). I certify that
this proposed rule will not have a significant economic impact on a
substantial number of small entities. The rationale for the
certification is that none of the companies proposed for Appendices A,
B, or C are construed to be a small entity within the definition of the
RFA. ``Small insurer'' is defined, in part under 49 U.S.C. 33112, as
any insurer whose premiums for all forms of motor vehicle insurance
account for less than 1 percent of the total premiums for all forms of
motor vehicle insurance issued by insurers within the United States, or
any insurer whose premiums within any State, account for less than 10
percent of the total premiums for all forms of motor vehicle insurance
issued by insurers within the State. This notice would exempt all
insurers meeting those criteria. Any insurer too large to meet those
criteria is not a small entity. In addition, in this rulemaking, the
agency proposes to exempt all ``self insured rental and leasing
companies'' that have fleets of fewer than 50,000 vehicles. Any self-
insured rental and leasing company too large to meet that criterion is
not a small entity.

4. Federalism

    This action has been analyzed according to the principles and
criteria contained in Executive Order 12612, and it has been determined
that the proposed rule does not have sufficient federalism implications
to warrant the preparation of a Federalism Assessment.

5. Environmental Impacts

    In accordance with the National Environmental Policy Act, NHTSA has
considered the environmental impacts of this proposed rule and
determined that it would not have a significant

impact on the quality of the human environment.

6. Regulation Identifier Number (RIN)

    The Department of Transportation assigns a regulation identifier
number (RIN) to each regulatory action listed in the Unified Agenda of
Federal Regulations. The Regulatory Information Service Center
publishes the Unified Agenda in April and October of each year. You may
use the RIN contained in the heading, at the beginning, of this
document to find this action in the Unified Agenda.

7. Plain Language

    Executive Order 12866 and the President's memorandum of June 1,
1998, require each agency to write all rules in plain language.
Application of the principles of plain language includes consideration
of the following questions:
     Have we organized the material to suit the public's needs?
     Are the requirements in the proposal clearly stated?
     Does the proposal contain technical language or jargon
that is not clear?
     Would a different format (grouping and order of sections,
use of headings, paragraphing) make the rule easier to understand?
     Would more (but shorter) sections be better?
     Could we improve clarity by adding tables, lists, or
diagrams?
     What else could we do to make the proposal easier to
understand?
    If you have any responses to these questions, you can forward them
to me several ways:
    a. Mail: Carlita Ballard, Office of International Policy, Fuel
Economy and Consumer Programs, NHTSA, 1200 New Jersey Avenue SE., (West
Building) Washington, DC 20590;
    b. Email<EMAIL_ADDRESS>or
    c. Fax:<PHONE_NUMBER>.

IV. Comments

Submission of Comments

1. How can I influence NHTSA's thinking on this proposed rule?
    In developing our rules, NHTSA tries to address the concerns of all
our stakeholders. Your comments will help us improve this rule. We
invite you to provide views on our proposal, new data, a discussion of
the effects of this proposal on you, or other relevant information. We
welcome your views on all aspects of this proposed rule. Your comments
will be most effective if you follow the suggestions below:
     Explain your views and reasoning clearly.
     Provide solid technical and cost data to support your
views.
     If you estimate potential costs, explain how you derived
the estimate.
     Provide specific examples to illustrate your concerns.
     Offer specific alternatives.
     Include the name, date and docket number with your
comments.
2. How do I prepare and submit comments?
    Your comments must be written in English. To ensure that your
comments are correctly filed in the Docket, please include the docket
number of this document in your comments.
    Your comments must not exceed 15 pages long (49 CFR 553.21). We
established this limit to encourage you to write your primary comments
concisely. You may attach necessary documents to your comments. We have
no limit on the attachments' length.
    Please submit two copies of your comments, including the
attachments, to Docket Management at the address given above under
ADDRESSES.
    Comments may also be submitted to the docket electronically by
logging onto the Federal eRulemaking Portal Web site at
http:www.regulation.gov. Follow the online instructions for submitting
comments.
3. How can I be sure that my comments were received?
    If you wish Docket Management to notify you, upon its receipt of
your comments, enclose a self-addressed, stamped postcard in the
envelope containing your comments. Upon receiving your comments, Docket
Management will mail the postcard.
4. How do I submit confidential business information?
    If you wish to submit any information under a confidentiality
claim, you should submit three copies of your complete submission,
including the information you claim as confidential business
information, to the Chief Counsel, Office of Chief Counsel, NHTSA, 1200
New Jersey Avenue SE., West Building, Washington, DC 20590. In
addition, you should submit two copies, from which you have deleted the
claimed confidential business information, to Docket Management at the
address given above under ADDRESSES. When you send a comment containing
information claimed to be confidential business information, you should
include a cover letter addressing the information specified in our
confidential business information regulation (49 CFR part 512).
5. Will the Agency consider late comments?
    NHTSA will consider all comments that Docket Management receives
before the close of business on the comment closing date indicated
above under DATES. To the extent possible, we will also consider
comments that Docket Management receives after that date. If Docket
Management receives a comment too late for us to consider, in
developing a final rule (assuming that one is issued), we will consider
that comment as an informal suggestion for future rulemaking action.
6. How can I read the comments submitted by other people?
    You may read the comments received by Docket Management at the
address given above under ADDRESSES. The hours of the Docket are
indicated above, in the same location. You may also see the comments on
the Internet. To read the comments on the Internet, log onto the
Federal eRulemaking Portal at http:www.regulation.gov.

V. Conclusion

    Based on the foregoing, we are proposing to amend Appendices B and
C of 49 CFR 544, Insurer Reporting Requirements. We are also amending
Sec.  544.5 to revise the example given the recent update to the
reporting requirements.

List of Subjects in 49 CFR Part 544

    Crime insurance, Insurance, Insurance companies, Motor vehicles,
Reporting and recordkeeping requirements.

    In consideration of the foregoing, 49 CFR part 544 is proposed to
be amended as follows:

PART 544--[AMENDED]

    1. The authority citation for part 544 continues to read as
follows:

    Authority: 49 U.S.C. 33112; delegation of authority at 49 CFR
1.50.

    2. Paragraph (a) of Sec.  544.5 is revised to read as follows:

Sec.  544.5  General requirements for reports.

    (a) Each insurer to which this part applies shall submit a report
annually before October 25, beginning on October 25, 1986. This report
shall contain the information required by Sec.  544.6 of this part for
the calendar year 3 years previous to the year in which the report is
filed (e.g., the report due by October 25, 2012, will contain the
required information for the 2009 calendar year).
* * * * *
    3. Appendix A to Part 544 is revised to read as follows:

Appendix A--Insurers of Motor Vehicle Insurance Policies Subject to the
Reporting Requirements in Each State in Which They Do Business

Allstate Insurance Group
American Family Insurance Group
Auto Club Enterprise Insurance Group
Auto-Owners Insurance Group
Berkshire Hathaway/GEICO Corporation Group
California State Auto Group \1\
---------------------------------------------------------------------------

    \1\ Indicates a newly listed company which must file a report
beginning with the report due October 25, 2012.
---------------------------------------------------------------------------

Erie Insurance Group
Farmers Insurance Group
Hartford Insurance Group
Liberty Mutual Insurance Companies
Metropolitan Life Auto & Home Group
Mercury General Group
Nationwide Group
Progressive Group
State Farm Group
Travelers Companies
USAA Group

    4. Appendix B to Part 544 is revised to read as follows:

Appendix B--Issuers of Motor Vehicle Insurance Policies Subject to the
Reporting Requirements Only in Designated States

Alfa Insurance Group (Alabama)
Auto Club (Michigan)
Commerce Group, Inc. (Massachusetts)
Kentucky Farm Bureau Group (Kentucky)
New Jersey Manufacturers Group (New Jersey)
Safety Group (Massachusetts)
Southern Farm Bureau Group (Arkansas, Mississippi)
Tennessee Farmers Companies (Tennessee)

    5. Appendix C to Part 544 is revised to read as follows:

Appendix C--Motor Vehicle Rental and Leasing Companies (Including
Licensees and Franchisees) Subject to the Reporting Requirements of
Part 544

Avis Budget Group (subsidiary of Cendant)
Dollar Thrifty Automotive Group
Enterprise Holding Inc./Enterprise Rent-A-Car Company
Hertz Rent-A-Car Division (subsidiary of The Hertz Corporation)
U-Haul International, Inc. (subsidiary of AMERCO)

    Issued on: May 8, 2012.
Christopher J. Bonanti,
Associate Administrator for Rulemaking.
[FR Doc. 2012-11565 Filed 5-11-12; 8:45 am]
BILLING CODE 4910-59-P


[Federal Register: July 10, 2009 (Volume 74, Number 131)]
[Rules and Regulations]
[Page 33159-33165]
[DOCID:fr10jy09-8]

-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2008-0271; FRL-8424-9]

Indoxacarb; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

-----------------------------------------------------------------------

SUMMARY: This regulation establishes tolerances for combined residues
of indoxacarb and its metabolites and degradates, to be determined by
measuring only indoxacarb and its R-enantiomer, in or on beet, garden,
roots; beet, garden, tops; and bushberry subgroup 13-07B. Interregional
Research Project Number 4 (IR-4) requested these tolerances under the
Federal Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective July 10, 2009. Objections and
requests for hearings must be received on or before September 8, 2009,
and must be filed in accordance with the instructions provided in 40
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: EPA has established a docket for this action under docket
identification (ID) number EPA-HQ-OPP-2008-0271. All documents in the
docket are listed in the docket index available at http://
www.regulations.gov. Although listed in the index, some information is
not publicly available, e.g., Confidential Business Information (CBI)
or other information whose disclosure is restricted by statute. Certain
other material, such as copyrighted material, is not placed on the
Internet and will be publicly available only in hard copy form.
Publicly available docket materials are available in the electronic
docket at http://www.regulations.gov, or, if only available in hard
copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac
Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The Docket
Facility is open from 8:30 a.m. to 4 p.m., Monday through Friday,
excluding legal holidays. The Docket Facility telephone number is (703)
305-5805.

FOR FURTHER INFORMATION CONTACT: Susan Stanton, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone
number:<PHONE_NUMBER>; e-mail address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
Potentially affected entities may include, but are not limited to those
engaged in the following activities:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).
    This listing is not intended to be exhaustive, but rather to
provide a guide for readers regarding entities likely to be affected by
this action. Other types of entities not listed in this unit could also
be affected. The North American Industrial Classification System
(NAICS) codes have been provided to assist you and others in
determining whether this action might apply to certain entities. If you
have any questions regarding the applicability of this action to a
particular entity, consult the person listed under FOR FURTHER
INFORMATION CONTACT.

B. How Can I Access Electronic Copies of this Document?

    In addition to accessing electronically available documents at
http://www.regulations.gov, you may access this Federal Register
document electronically through the EPA Internet under the ``Federal
Register'' listings at http://www.epa.gov/fedrgstr. You may also access
a frequently updated electronic version of EPA's tolerance regulations
at 40 CFR part 180 through the Government Printing Office's e-CFR cite
at http://www.gpoaccess.gov/ecfr. To access the OPPTS Harmonized
Guidelines referenced in this document, go directly to the guidelines
at http://www.epa.gpo/opptsfrs/home/guidelin.htm.

C. Can I File an Objection or Hearing Request?

    Under section 408(g) of FFDCA, 21 U.S.C. 346a, any person may file
an objection to any aspect of this regulation and may also request a
hearing on those objections. You must file your objection or request a
hearing on this regulation in accordance with the instructions provided
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify
docket ID number EPA-HQ-OPP-2008-0271 in the subject line on the first
page of your submission. All requests must be in writing, and must be
mailed or delivered to the Hearing Clerk as required by 40 CFR part 178
on or before September 8, 2009.
    In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing that does not contain any CBI for inclusion in the public
docket that is described in ADDRESSES. Information not marked
confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA
without prior notice. Submit this copy, identified by docket ID number
EPA-HQ-OPP-2008-0271, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the on-line instructions for submitting comments.
     Mail: Office of Pesticide Programs (OPP) Regulatory Public
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001.

     Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only
accepted during the Docket Facility's normal hours of operation (8:30
a.m. to 4 p.m., Monday through Friday, excluding legal holidays).
Special arrangements should be made for deliveries of boxed
information. The Docket Facility telephone number is<PHONE_NUMBER>.

II. Petition for Tolerance

    In the Federal Register of May 16, 2008 (73 FR 28461) (FRL-8361-6),
EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 U.S.C.
346a(d)(3), announcing the filing of a pesticide petition (PP 8E7324)
by Interregional Research Project Number 4 (IR-4), 500 College Road
East, Suite 201 W, Princeton, NJ 08540. The petition requested that 40
CFR 180.564 be amended by establishing tolerances for combined residues
of the insecticide indoxacarb, (S)-methyl 7-chloro-2,5-dihydro-2-
[[(methoxycarbonyl)[4-
(trifluoromethoxy)phenyl]amino]carbonyl]indeno[1,2-
e][1,3,4][oxadiazine-4a(3H)-carboxylate, and its R-enantiomer, (R)-
methyl 7-chloro-2,5-dihydro-2-[[(methoxycarbonyl)[4-
(trifluoromethoxy)phenyl]amino]carbonyl]indeno[1,2-
e][1,3,4][oxadiazine-4a(3H)-carboxylate, in or on beet, garden, roots
at 0.30 parts per million (ppm); beet, garden, tops at 6.0 ppm; and
bushberry subgroup 13-07B at 1.5 ppm. That notice referenced a summary
of the petition prepared on behalf of IR-4 by E.I. du Pont de Nemours
and Company, the registrant, which is available to the public in the
docket, http://www.regulations.gov. There were no comments received in
response to the notice of filing.

III. Aggregate Risk Assessment and Determination of Safety

    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a
reasonable certainty that no harm will result from aggregate exposure
to the pesticide chemical residue, including all anticipated dietary
exposures and all other exposures for which there is reliable
information.'' This includes exposure through drinking water and in
residential settings, but does not include occupational exposure.
Section 408(b)(2)(C) of FFDCA requires EPA to give special
consideration to exposure of infants and children to the pesticide
chemical residue in establishing a tolerance and to ``ensure that there
is a reasonable certainty that no harm will result to infants and
children from aggregate exposure to the pesticide chemical
residue....''
    Consistent with section 408(b)(2)(D) of FFDCA, and the factors
specified in section 408(b)(2)(D) of FFDCA, EPA has reviewed the
available scientific data and other relevant information in support of
this action. EPA has sufficient data to assess the hazards of and to
make a determination on aggregate exposure for the petitioned-for
tolerances for combined residues of indoxacarb and its metabolites and
degradates, to be determined by measuring only indoxacarb and its R-
enantiomer, on beet, garden, roots at 0.30 ppm; beet, garden, tops at
6.0 ppm; and bushberry subgroup 13-07B at 1.5 ppm. EPA's assessment of
exposures and risks associated with establishing these tolerances
follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered its
validity, completeness, and reliability as well as the relationship of
the results of the studies to human risk. EPA has also considered
available information concerning the variability of the sensitivities
of major identifiable subgroups of consumers, including infants and
children.
    Indoxacarb is the S-enantiomer of an isomeric compound containing
two enantiomers, the S-enantiomer (DPX-KN128, the insecticidally active
component) and its R-enantiomer (DPX-KN127, the insecticidally inactive
component). DPX-MP062 is an enantiomeric mixture containing the S-
enantiomer and its R-enantiomer at approximately a 75:25 ratio. DPX-
JW062 is the racemic mixture of the enantiomers at a 50:50 ratio.
    DPX-KN128, DPX-MP062 and DPX-JW062 appear to be of similar toxicity
acutely. DPX-KN128 and DPX-MP062 were moderately acutely toxic by the
oral route while DPX-JW062 was practically non-toxic due to its poor
solubility in the corn oil vehicle. However, it was equally toxic
orally, when tested using a solvent where it had a higher solubility,
such as polyethylene glycol (PEG). By the dermal route, they had low
toxicity. DPX-MP062 and DPX-JW062 had low acute inhalation toxicity.
DPX-MP062 and DPX-JW062 had moderate to low ocular irritant properties,
while DPX-KN128 was practically non-irritating to the rabbit's eyes. By
the maximization test, DPX-KN128 and DPX-MP062 were considered dermal
sensitizers, while DPX-JW062 was not a sensitizer.
    There was possible evidence of lung damage in the acute inhalation
studies with both DPX-MP062 and DPX-JW062. ``Lung noise,'' observed
with JW062, may indicate the development of acute lung injury and high
permeability pulmonary edema. This was not unexpected since an oxidant
was generated during indoxacarb metabolism. ``Hunched over back and
gasping'' were also present and suggested arterial hypoxemia that
accompanies alveolar flooding. The acute inhalation study report with
indoxacarb 70% manufacturing use product noted that a ``red nasal
discharge'' was detected for 2 days after exposure. This may be
indicative of a lung exudate, a sign of lung injury. Subchronic (28
days) inhalation toxicity of indoxacarb in rats was characterized by
increased spleen weights, increased pigmentation and hematopoiesis in
the spleen, and hematological changes.
    The toxicity profiles for DPX-KN128, DPX-MP062, and DPX-JW062 in
rats, mice, and dogs with both subchronic and chronic oral exposures
were similar. Dermal subchronic exposure in the rat also resulted in a
similar profile. The toxic signs occurred at similar doses and with a
similar magnitude of response, with females generally being more
sensitive than males. The endpoints that most frequently defined the
lowest-observed-adverse-effect-level (LOAEL) were non-specific, and
included decreased body weight, weight gain, food consumption, and food
efficiency. These compounds also affected the hematopoietic system by
decreasing the red blood cell count, hemoglobin, and hematocrit in
rats, dogs and mice. It was frequently accompanied by an increase in
reticulocytes in all three species and an increase in Heinz bodies
(dogs and mice only). None of these signs of toxicity appeared to get
worse over time. In one subchronic rat study, the parameters appeared
to return to normal levels following a four-week recovery period. High
doses in the rats and mice also sometimes caused mortality.
    There was no evidence of increased susceptibility of fetuses or
offspring from either in utero or neonatal exposure to DPX-MP062 or
DPX-JW062. There was no evidence of increased susceptibility from in
utero exposure of rats to DPX-KN128. There was no evidence of increased
susceptibility in the developmental neurotoxicity study in rats with
DPX-KN128. No evidence of teratogenicity was observed in rats and
rabbits with

DPX-MP062 or DPX-JW062. No evidence of teratogenicity was observed in
rats with DPX-KN128. There was no evidence of reproductive effects in
the 2-generation reproduction study in rats.
    Neurotoxicity was observed in both rats and mice; however, it did
not occur in the absence of other signs of toxicity. Neurotoxicity was
characterized by one or more of the following symptoms in both male and
female rats and mice: Weakness, head tilting, and abnormal gait or
mobility with inability to stand and ataxia. Acute and subchronic
neurotoxicity screening batteries were performed using DPX-MP062 in
rats. Neurotoxicity was characterized by clinical signs (depression,
abnormal gait, head shake, salivation) and functional-observation
battery (FOB) effects (circling behavior, incoordination, slow righting
reflex, decreased forelimb grip strength, decreased foot splay,
decreased motor activity). However, there was no evidence of
neurohistopathology in any study. Learning and memory parameters were
affected in the pups in the developmental neurotoxicity study in rats
with DPX-KN128.
    There was no evidence of carcinogenicity in either the rat or mouse
in acceptable studies using DPX-JW062. DPX-JW062 was not mutagenic in a
complete battery of mutagenicity studies. There was also no evidence of
mutagenicity with either DPX-KN128, or DPX-MP062.
    Both DPX-JW062 and DPX-MP062 were rapidly absorbed and eliminated
following oral administration. The absorption of DPX-JW062 was dose
dependent and appeared to be saturated at the high dose. Both urine and
feces represented major routes of excretion (35-45% and 33-47%,
respectively). The distribution pattern did not vary with dosing
regimen and overall tissue burden was limited to only 3.4-12.9% of the
administered dose. The red blood cells of rats dosed with the
trifluoromethoxyphenyl label consistently contained much greater levels
of radioactivity than did plasma. Fat tissue contained the greatest
level of radioactivity (1.76-8.76% of the administered dose) and, for
both compounds, was greater in female rats. The finding also
demonstrates a greater propensity for accumulation by female rats than
by male rats. Both DPX-MP062 and DPX-JW062 were extensively metabolized
and the metabolites were eliminated in the urine, feces, and bile. With
the exception of parent compound (DPX-JW062, which accounted for 19.2%
of a single low dose in the feces of female rats), none of the
metabolites from any source represented more than 12.3% of the
administered dose. The metabolite profile for DPX-JW062 was dose
dependent and varied quantitatively between males and females.
Differences in metabolite profiles were also observed for the different
label positions. All of the biliary metabolites appear to undergo
further biotransformation in the gut.
    Specific information on the studies received and the nature of the
adverse effects caused by indoxacarb as well as the no-observed-
adverse-effect-level (NOAEL) and the LOAEL from the toxicity studies
can be found at http://www.regulations.gov in the document Indoxacarb.
Health Effects Division (HED) Human Health Risk Assessment for
Bushberry Crop Subgroup 13-07B and Beets (Garden), page 13 in docket ID
number EPA-HQ-OPP-2008-0271.

B. Toxicological Endpoints

    For hazards that have a threshold below which there is no
appreciable risk, a toxicological point of departure (POD) is
identified as the basis for derivation of reference values for risk
assessment. The POD may be defined as the highest dose at which the
NOAEL in the toxicology study identified as appropriate for use in risk
assessment. However, if a NOAEL cannot be determined, the LOAEL or a
Benchmark Dose (BMD) approach is sometimes used for risk assessment.
Uncertainty/safety factors (UFs) are used in conjunction with the POD
to take into account uncertainties inherent in the extrapolation from
laboratory animal data to humans and in the variations in sensitivity
among members of the human population as well as other unknowns. Safety
is assessed for acute and chronic dietary risks by comparing aggregate
food and water exposure to the pesticide to the acute population
adjusted dose (aPAD) and chronic population adjusted dose (cPAD). The
aPAD and cPAD are calculated by dividing the POD by all applicable UFs.
Aggregate short-, intermediate-, and chronic-term risks are evaluated
by comparing food, water, and residential exposure to the POD to ensure
that the margin of exposure (MOE) called for by the product of all
applicable UFs is not exceeded. This latter value is referred to as the
Level of Concern (LOC).
    For non-threshold risks, the Agency assumes that any amount of
exposure will lead to some degree of risk. Thus, the Agency estimates
risk in terms of the probability of an occurrence of the adverse effect
greater than that expected in a lifetime. For more information on the
general principles EPA uses in risk characterization and a complete
description of the risk assessment process, see http://www.epa.gov/
pesticides/factsheets/riskassess.htm.
    A summary of the toxicological endpoints for indoxacarb used for
human risk assessment can be found at http://www.regulations.gov in the
document Indoxacarb. Health Effects Division (HED) Human Health Risk
Assessment for Bushberry Crop Subgroup 13-07B and Beets (Garden), page
18 in docket ID number EPA-HQ-OPP-2008-0271.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to indoxacarb, EPA considered exposure under the petitioned-
for tolerances as well as all existing indoxacarb tolerances in 40 CFR
180.564. EPA assessed dietary exposures from indoxacarb in food as
follows:
    i. Acute exposure. Quantitative acute dietary exposure and risk
assessments are performed for a food-use pesticide, if a toxicological
study has indicated the possibility of an effect of concern occurring
as a result of a 1-day or single exposure.
    In estimating acute dietary exposure, EPA used food consumption
information from the United States Department of Agriculture (USDA)
1994-1996 and 1998 Nationwide Continuing Surveys of Food Intake by
Individuals (CSFII). As to residue levels in food, for most currently
registered commodities, EPA used anticipated residues derived from
field trial data and maximum percent crop treated (PCT) estimates. EPA
assumed tolerance-level residues and 100 PCT for the new commodities
associated with this petition (garden beets and bushberries). Available
processing data for indoxacarb were used to refine anticipated residues
for apples/pears (juice), potato (dry, chips), cotton (oil), tomato
(paste and puree), peanut (oil), soybean (oil), grapes (raisin and
juice), prunes (dried), mint (oil), and other commodities where
translation was appropriate. For all other processed commodities, DEEM-
FCID\TM\ (ver. 7.81) default processing factors were assumed.
    ii. Chronic exposure. In conducting the chronic dietary exposure
assessment EPA used the food consumption data from the USDA 1994-1996
and 1998 CSFII. As to residue levels in food, EPA relied upon
anticipated residues derived from field trial data for most of the
registered and new commodities and an anticipated residue value for
milk derived from monitoring data collected by the United States
Department of Agriculture's Pesticide Data Program

(PDP). Residue estimates were further refined using average PCT data
and available processing data, as described in Unit III.C.i. EPA
assumed 100 PCT for the new commodities, garden beets and bushberries.
    iii. Cancer. Based on the results of carcinogenicity studies in
rats and mice, EPA classified indoxacarb as ``not likely'' to be
carcinogenic to humans via relevant routes of exposure. Therefore, an
exposure assessment for evaluating cancer risk is unnecessary.
    iv. Anticipated residue and percent crop treated (PCT) information.
Section 408(b)(2)(E) of FFDCA authorizes EPA to use available data and
information on the anticipated residue levels of pesticide residues in
food and the actual levels of pesticide residues that have been
measured in food. If EPA relies on such information, EPA must require
pursuant to FFDCA section 408(f)(1) that data be provided 5 years after
the tolerance is established, modified, or left in effect,
demonstrating that the levels in food are not above the levels
anticipated. For the present action, EPA will issue such data call-ins
as are required by FFDCA section 408(b)(2)(E) and authorized under
FFDCA section 408(f)(1). Data will be required to be submitted no later
than 5 years from the date of issuance of these tolerances.
    Section 408(b)(2)(F) of FFDCA states that the Agency may use data
on the actual percent of food treated for assessing chronic dietary
risk only if:
     Condition a: The data used are reliable and provide a
valid basis to show what percentage of the food derived from such crop
is likely to contain the pesticide residue.
     Condition b: The exposure estimate does not underestimate
exposure for any significant subpopulation group.
     Condition c: Data are available on pesticide use and food
consumption in a particular area, the exposure estimate does not
understate exposure for the population in such area.
In addition, the Agency must provide for periodic evaluation of any
estimates used. To provide for the periodic evaluation of the estimate
of PCT as required by FFDCA section 408(b)(2)(F), EPA may require
registrants to submit data on PCT.
    The Agency used PCT information as follows:
    Acute dietary exposure assessment: Apple 5%, broccoli 50%, cabbage
25%, cauliflower 55%, cherry 2.5%, corn (sweet) 2.5%, lettuce (head)
25%, lettuce (leaf) 11%, peach 2.5%, peanut 2.5%, pear 2.5%, pepper
15%, potato 2.5%, soybean 1%, spinach 5%, and tomato 25%.
    Chronic dietary exposure assessment: Apple 1%, broccoli 40%,
cabbage 15%, cauliflower 35%, cherry 1%, lettuce (head) 18%, lettuce
(leaf) 9%, peach 1%, peanut 1%, pear 1%, pepper 10%, potato 1%, soybean
1%, spinach 5%, and tomato 15%.
    In most cases, EPA uses available data from United States
Department of Agriculture/National Agricultural Statistics Service
(USDA/NASS), proprietary market surveys, and the National Pesticide Use
Database for the chemical/crop combination for the most recent 6 years.
EPA uses an average PCT for chronic dietary risk analysis. The average
PCT figure for each existing use is derived by combining available
public and private market survey data for that use, averaging across
all observations, and rounding to the nearest 5%, except for those
situations in which the average PCT is less than one. In those cases,
1% is used as the average PCT and 2.5% is used as the maximum PCT. EPA
uses a maximum PCT for acute dietary risk analysis. The maximum PCT
figure is the highest observed maximum value reported within the recent
6 years of available public and private market survey data for the
existing use and rounded up to the nearest multiple of 5%.
    The Agency believes that the three conditions discussed in Unit
III.C.1.iv. have been met. With respect to Condition a, PCT estimates
are derived from Federal and private market survey data, which are
reliable and have a valid basis. The Agency is reasonably certain that
the percentage of the food treated is not likely to be an
underestimation. As to Conditions b and c, regional consumption
information and consumption information for significant subpopulations
is taken into account through EPA's computer-based model for evaluating
the exposure of significant subpopulations including several regional
groups. Use of this consumption information in EPA's risk assessment
process ensures that EPA's exposure estimate does not understate
exposure for any significant subpopulation group and allows the Agency
to be reasonably certain that no regional population is exposed to
residue levels higher than those estimated by the Agency. Other than
the data available through national food consumption surveys, EPA does
not have available reliable information on the regional consumption of
food to which indoxacarb may be applied in a particular area.
    2. Dietary exposure from drinking water. The Agency used screening
level water exposure models in the dietary exposure analysis and risk
assessment for indoxacarb in drinking water. These simulation models
take into account data on the physical, chemical, and fate/transport
characteristics of indoxacarb. Further information regarding EPA
drinking water models used in pesticide exposure assessment can be
found at http://www.epa.gov/oppefed1/models/water/index.htm.
    Based on the Pesticide Root Zone Model /Exposure Analysis Modeling
System (PRZM/EXAMS) and Screening Concentration in Ground Water (SCI-
GROW) models, the estimated drinking water concentrations (EDWCs) of
indoxacarb for acute exposures are estimated to be 25.1 parts per
billion (ppb) for surface water and 0.21 ppb for ground water. The
EDWCs of indoxacarb for chronic exposures for non-cancer assessments
are estimated to be 5.37 ppb for surface water and 0.21 ppb for ground
water.
    Modeled estimates of drinking water concentrations were directly
entered into the dietary exposure model. For acute dietary risk
assessment, the water concentration value of 25.1 ppb was used to
assess the contribution to drinking water. For chronic dietary risk
assessment, the water concentration of value 5.37 ppb was used to
assess the contribution to drinking water.
    3. From non-dietary exposure. The term ``residential exposure'' is
used in this document to refer to non-occupational, non-dietary
exposure (e.g., for lawn and garden pest control, indoor pest control,
termiticides, and flea and tick control on pets).
    Indoxacarb is currently registered for several uses that could
result in residential, non-dietary exposures. Indoxacarb is registered
for use as a fire ant bait, which may be applied as a mound treatment
or as a broadcast application to lawns, golf courses, and other
recreational areas. Indoxacarb is also registered as a mole cricket
bait applied as a broadcast treatment to lawns, golf courses, parks,
recreational areas, and athletic fields. Finally, indoxacarb is
registered as a foliar or broadcast spray to control lepidopterous
larvae on landscape and recreational (including golf courses) turfgrass
and ornamentals. EPA assessed residential exposure using the following
assumptions:
    Based on the residential use patterns, commercial and private
(i.e., grower/homeowner) pesticide handlers are expected to have short-
term (1-30 days) dermal and inhalation exposures to indoxacarb.
Commercial handlers may also have intermediate-term exposures (1-6
months). The short- and intermediate-term toxicological points of
departure are the same; therefore, the

risk estimates for intermediate-term exposures are the same as those
for short-term exposures.
    There is also the potential for short- and intermediate-term
postapplication exposure of adults and children from entering areas
previously treated with indoxacarb. The postapplication exposure
scenarios assessed include: Dermal exposure from treated lawns due to
high contact lawn activities (adult and toddler); Dermal exposure from
treated turf due to golfing (adults and youths); Hand-to-mouth transfer
of pesticide residues on lawns (toddler); Episodic incidental ingestion
of granules from pesticide-treated residential areas (toddler);
Incidental ingestion of soil from pesticide-treated residential areas
(toddler); and Incidental oral object-to-mouth exposure from pesticide-
treated residential areas (toddler).
    Postapplication inhalation exposures are expected to be negligible
and, therefore, were not assessed.
    4. Cumulative effects from substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when
considering whether to establish, modify, or revoke a tolerance, the
Agency consider ``available information'' concerning the cumulative
effects of a particular pesticide's residues and ``other substances
that have a common mechanism of toxicity.''
    EPA has not found indoxacarb to share a common mechanism of
toxicity with any other substances, and indoxacarb does not appear to
produce a toxic metabolite produced by other substances. For the
purposes of this tolerance action, therefore, EPA has assumed that
indoxacarb does not have a common mechanism of toxicity with other
substances. For information regarding EPA's efforts to determine which
chemicals have a common mechanism of toxicity and to evaluate the
cumulative effects of such chemicals, see EPA's website at http://
www.epa.gov/pesticides/cumulative.

D. Safety Factor for Infants and Children

    1. In general. Section 408(b)(2)(c) of FFDCA provides that EPA
shall apply an additional tenfold (10X) margin of safety for infants
and children in the case of threshold effects to account for prenatal
and postnatal toxicity and the completeness of the database on toxicity
and exposure unless EPA determines based on reliable data that a
different margin of safety will be safe for infants and children. This
additional margin of safety is commonly referred to as the FQPA safety
factor (SF). In applying this provision, EPA either retains the default
value of 10X, or uses a different additional safety factor when
reliable data available to EPA support the choice of a different
factor.
    2. Prenatal and postnatal sensitivity. There was no quantitative or
qualitative evidence of increased prenatal or postnatal sensitivity in
the two developmental toxicity studies in rats with DPX-JW062, one
developmental toxicity study in rats with DPX-MP062 and DPX-KN128, one
developmental toxicity study in rabbits with DPX-JW062, one 2-
generation reproduction studies in rats with DPX-JW062 and a
developmental neurotoxicity (DNT) study in rats with DPX-KN128. In
these studies, developmental toxicity was observed in the presence of
maternal toxicity.
    3. Conclusion. EPA has determined that reliable data show the
safety of infants and children would be adequately protected if the
FQPA SF were reduced to 1X. That decision is based on the following
findings:
    i. With the exception of an immunotoxicity study, now mandatory
under the 40 CFR part 158 Data Requirements for Pesticides, the
toxicological database for indoxacarb is complete. The available data
do not indicate that indoxacarb is immunotoxic. In the 28-day
inhalation study in rats, increased spleen weights, pigmentation and
hematopoiesis in the spleen, and hematological changes were observed at
the highest dose tested (75.6 mg/kg/day). Increased spleen weights were
also observed in the 28-day dermal rat study at 500 mg/kg/day. The
increase in spleen weights is not considered immunological in origin
but can be considered a result of the hemolytic effects, which is the
mode of action of indoxacarb. Indoxacarb is currently regulated based
on a NOAEL of 1.5 mg/kg/day for chronic dietary exposure (protective of
hemolytic effects) and 9 mg/kg/day for acute dietary exposure. EPA does
not believe that conducting a special series 870.7800 immunotoxicity
study will result in NOAELs lower than those currently identified for
indoxacarb, and an additional uncertainty factor is not needed to
account for immunotoxicity.
    ii. EPA has determined that an additional uncertainty factor is not
needed to account for neurotoxicity. Neurotoxicity was seen in animal
studies in rats and mice but at higher doses than the hematologic
effects on which EPA's risk assessments are based. To evaluate the
potential for increased sensitivity of infants and children to
neurotoxic effects, EPA required a rat developmental neurotoxicity
(DNT) study. The study has been submitted and reviewed. There was no
evidence of increased sensitivity of offspring in the submitted study.
Clinical observations, motor activity, acoustic startle habituation,
and learning and memory testing were all comparable between the control
and treated groups. Mean brain weight, gross and microscopic
examinations, and morphometric measurements of the brain were also
comparable between the controls and treated groups.
    iii. There is no evidence that indoxacarb results in increased
susceptibility in in utero rats or rabbits in the prenatal
developmental studies or in young rats in the 2-generation reproduction
study.
    iv. There are no residual uncertainties identified in the exposure
databases. The acute and chronic dietary food exposure assessments
utilize anticipated residues that are based on reliable field trial and
monitoring data. They also utilize PCT data that have been verified by
the Agency for most existing uses. For the new uses, a conservative
estimate of 100 PCT is assumed. EPA made conservative (protective)
assumptions in the ground and surface water modeling used to assess
exposure to indoxacarb in drinking water. EPA used similarly
conservative assumptions to assess postapplication exposure of children
as well as incidental oral exposure of toddlers. These assessments will
not underestimate the exposure and risks posed by indoxacarb.

E. Aggregate Risks and Determination of Safety

    EPA determines whether acute and chronic pesticide exposures are
safe by comparing aggregate exposure estimates to the aPAD and cPAD.
The aPAD and cPAD represent the highest safe exposures, taking into
account all appropriate SFs. EPA calculates the aPAD and cPAD by
dividing the POD by all applicable UFs. For linear cancer risks, EPA
calculates the probability of additional cancer cases given the
estimated aggregate exposure. Short-, intermediate-, and chronic-term
risks are evaluated by comparing the estimated aggregate food, water,
and residential exposure to the POD to ensure that the MOE called for
by the product of all applicable UFs is not exceeded.
    1. Acute risk. An acute aggregate risk assessment takes into
account exposure estimates from acute dietary consumption of food and
drinking water. Using the exposure assumptions discussed in this unit
for acute exposure, the acute dietary exposure from food and water to
indoxacarb will

occupy 63% of the aPAD for children 3 to 5 years old, the population
group receiving the greatest exposure.
    2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that chronic exposure to
indoxacarb from food and water will utilize 6.6% of the cPAD for
children 1 to 2 years old, the population group receiving the greatest
exposure. Based on the explanation in Unit III.C.3., regarding
residential use patterns, chronic residential exposure to residues of
indoxacarb is not expected.
    3. Short- and intermediate-term risk. Short- and intermediate-term
aggregate exposures take into account short- or intermediate-term
residential exposure plus chronic exposure from food and water
(considered to be a background exposure level). Indoxacarb is currently
registered for uses that could result in short- and intermediate-term
residential exposures and the Agency has determined that it is
appropriate to aggregate chronic exposure through food and water with
short- and intermediate-term residential exposures to indoxacarb.
    Using the exposure assumptions described in this unit for short-
and intermediate-term exposures, EPA has concluded the combined short-/
intermediate-term food, water, and residential exposures aggregated
result in aggregate MOEs of 320 for adults and 102 for children
(toddlers). The aggregate MOE for adults includes dietary exposures
from food and drinking water, as well as dermal handler and
postapplication exposures from the residential use of indoxacarb on
turf for mole cricket control, the residential scenario resulting in
the highest estimated exposures. Similarly, the aggregate MOE for
toddlers includes dietary (food and drinking water) and residential
exposures. The residential exposure estimate for toddlers is also based
on the worst-case turf scenario (mole cricket control) and includes
dermal and incidental oral postapplication exposures. The highest
estimated incidental oral exposures for toddlers are from hand-to-mouth
activities on treated turf; therefore, the oral hand-to-mouth exposures
were used to calculate the aggregate MOE for toddlers.
    5. Aggregate cancer risk for U.S. population. EPA has classified
indoxacarb as ``not likely'' to be carcinogenic to humans via relevant
routes of exposure. Indoxacarb is not expected to pose a cancer risk.
    6. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
to the general population, or to infants and children from aggregate
exposure to indoxacarb residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (high-performance liquid
chromatography (HPLC)/column switching/ultraviolet (UV) method AMR
2712-93 with confirmation/specificity provided by gas chromatography
(GC)/mass-selective detector method AMR 3493-95, Supplement No. 4) is
available to enforce the tolerance expression. The method may be
requested from: Chief, Analytical Chemistry Branch, Environmental
Science Center, 701 Mapes Rd., Ft. Meade, MD 20755-5350; telephone
number:<PHONE_NUMBER>; e-mail address<EMAIL_ADDRESS>
B. International Residue Limits

    There are no established or proposed Codex, Canadian or Mexican
maximum residue limits (MRLs) for indoxacarb on bushberries or garden
beets.

C. Changes to Proposed Tolerances

    Tolerances for indoxacarb are currently expressed in terms of
``combined residues of indoxacarb, (S)-methyl 7-chloro-2,5-dihydro-2-
[[(methoxycarbonyl)[4-
(trifluoromethoxy)phenyl]amino]carbonyl]indeno[1,2-
e][1,3,4][oxadiazine-4a(3H)-carboxylate, and its R-enantiomer, (R)-
methyl 7-chloro-2,5-dihydro-2-[[(methoxycarbonyl)[4-
(trifluoromethoxy)phenyl]amino]carbonyl]indeno[1,2-
e][1,3,4][oxadiazine-4a(3H)-carboxylate.'' EPA is revising the
tolerance expression for existing tolerances and the proposed
tolerances on garden beets and bushberries to clarify the chemical
moieties that are covered by the tolerances and specify how compliance
with the tolerances is to be measured. The revised tolerance expression
makes clear that the tolerance covers ``residues of indoxacarb,
including its metabolites and degradates,'' and that compliance with
the tolerance levels will be determined by measuring only indoxacarb,
(S)-methyl 7-chloro-2,5-dihydro-2-[[(methoxycarbonyl)[4-
(trifluoromethoxy)phenyl]amino]carbonyl]indeno[1,2-
e][1,3,4][oxadiazine-4a(3H)-carboxylate, and its R-enantiomer, (R)-
methyl 7-chloro-2,5-dihydro-2-[[(methoxycarbonyl)[4-
(trifluoromethoxy)phenyl]amino]carbonyl]indeno[1,2-
e][1,3,4][oxadiazine-4a(3H)-carboxylate.
    EPA has determined that it is reasonable to make this change final
without prior proposal and opportunity for comment, because public
comment is not necessary, in that the change has no substantive effect
on the tolerance, but rather is merely intended to clarify the existing
tolerance expression.

V. Conclusion

    Therefore, tolerances are established for residues of indoxacarb,
including its metabolites and degradates, in or on beet, garden, roots
at 0.30 ppm; beet, garden, tops at 6.0 ppm; and bushberry subgroup 13-
07B at 1.5 ppm. Compliance with these tolerance levels is to be
determined by measuring only indoxacarb, (S)-methyl 7-chloro-2,5-
dihydro-2-[[(methoxycarbonyl)[4-
(trifluoromethoxy)phenyl]]amino]carbonyl]indeno[1,2-
e][1,3,4][oxadiazine-4a(3H)-carboxylate, and its R-enantiomer, (R)-
methyl 7-chloro-2,5-dihydro-2-[[(methoxycarbonyl)[4-
(trifluoromethoxy)phenyl]amino]carbonyl]indeno[1,2-
e][1,3,4][oxadiazine-4a(3H)-carboxylate.

VI. Statutory and Executive Order Reviews

    This final rule establishes tolerances under section 408(d) of
FFDCA in response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled Regulatory Planning and
Review (58 FR 51735, October 4, 1993). Because this final rule has been
exempted from review under Executive Order 12866, this final rule is
not subject to Executive Order 13211, entitled Actions Concerning
Regulations That Significantly Affect Energy Supply, Distribution, or
Use (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled
Protection of Children from Environmental Health Risks and Safety Risks
(62 FR 19885, April 23, 1997). This final rule does not contain any
information collections subject to OMB approval under the Paperwork
Reduction Act (PRA), 44 U.S.C. 3501 et seq., nor does it require any
special considerations under Executive Order 12898, entitled Federal
Actions to Address Environmental Justice in Minority Populations and
Low-Income Populations (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis
of a petition under section 408(d) of FFDCA, such as the tolerance in
this final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory

Flexibility Act (RFA) (5 U.S.C. 601 et seq.) do not apply.
    This final rule directly regulates growers, food processors, food
handlers, and food retailers, not States or tribes, nor does this
action alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of section 408(n)(4) of FFDCA. As such, the Agency has determined that
this action will not have a substantial direct effect on States or
tribal governments, on the relationship between the national government
and the States or tribal governments, or on the distribution of power
and responsibilities among the various levels of government or between
the Federal Government and Indian tribes. Thus, the Agency has
determined that Executive Order 13132, entitled Federalism (64 FR
43255, August 10, 1999) and Executive Order 13175, entitled
Consultation and Coordination with Indian Tribal Governments (65 FR
67249, November 9, 2000) do not apply to this final rule. In addition,
this final rule does not impose any enforceable duty or contain any
unfunded mandate as described under Title II of the Unfunded Mandates
Reform Act of 1995 (UMRA) (Public Law 104-4).
    This action does not involve any technical standards that would
require Agency consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272
note).

VII. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report to each House of the Congress and to
the Comptroller General of the United States. EPA will submit a report
containing this rule and other required information to the U.S. Senate,
the U.S. House of Representatives, and the Comptroller General of the
United States prior to publication of this final rule in the Federal
Register. This final rule is not a ``major rule'' as defined by 5
U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.

    Dated: July 1, 2009.
G. Jeffrey Herndon,
Acting Director, Registration Division, Office of Pesticide Programs.

0
Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

0
1. The authority citation for part 180 continues to read as follows:

    Authority: 21 U.S.C. 321(q), 346a and 371.

0
2. Section 180.564 is amended in paragraph (a) by revising the
introductory text and by alphabetically adding the following
commodities to the table to read as follows:

Sec. 180.564  Indoxacarb; tolerances for residues.

    (a) General. Tolerances are established for residues of indoxacarb,
including its metabolites and degradates, in or on the commodities in
the table below. Compliance with the tolerance levels specified below
is to be determined by measuring only indoxacarb, (S)-methyl 7-chloro-
2,5-dihydro-2-[[(methoxycarbonyl)[4-
(trifluoromethoxy)phenyl]amino]carbonyl]indeno[1,2-
e][1,3,4][oxadiazine-4a(3H)-carboxylate, and its R-enantiomer, (R)-
methyl 7-chloro-2,5-dihydro-2-[[(methoxycarbonyl)[4-
(trifluoromethoxy)phenyl]amino]carbonyl]indeno[1,2-
e][1,3,4][oxadiazine-4a(3H)-carboxylate.

------------------------------------------------------------------------
                   Commodity                        Parts per million
------------------------------------------------------------------------
                                * * * * *
Beet, garden, roots............................                     0.30
Beet, garden, tops.............................                      6.0
Bushberry subgroup 13-07B......................                      1.5
                                * * * * *
------------------------------------------------------------------------

* * * * *

[FR Doc. E9-16368 Filed 7-9-09; 8:45 am]

BILLING CODE 6560-50-S


[Federal Register Volume 79, Number 245 (Monday, December 22, 2014)]
[Rules and Regulations]
[Pages 76233-76235]
[FR Doc No: 2014-29850]

=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket No. USCG-2014-1032]
RIN 1625-AA00

Safety Zone, Elizabeth River; Portsmouth, VA

AGENCY: Coast Guard, DHS.

ACTION: Temporary Final Rule.

-----------------------------------------------------------------------

SUMMARY: The Coast Guard is establishing a safety zone on the navigable
waters of the Elizabeth River in Portsmouth, VA for 10 periods of 48
hours beginning at midnight on February 18, February 23, February 26,
March 3, March 9, April 20, April 23, April 27, April 30, and May 11,
2015. This action will restrict vessel traffic movement in the
designated area during construction of the new Midtown Tunnel. This
action is necessary to protect the life and property of the maritime
public due to the number of work vessels in the designated area and
their lack of maneuverability while engaged in construction operations.

DATES: This rule is effective from December 22, 2014 through May 11,
2015, and will be enforced for 10 periods of 48 hours in length,
beginning at midnight on February 18, February 23, February 26, March
3, March 9, April 20, April 23, April 27, April 30, and May 11, 2015.

ADDRESSES: Documents mentioned in this preamble are part of docket
[USCG-2014-1032]. To view documents mentioned in this preamble as being
available in the docket, go to http://www.regulations.gov, type the
docket number in the ``SEARCH'' box and click ``SEARCH.'' Click on Open
Docket Folder on the line associated with this rulemaking. You may also
visit the Docket Management Facility in Room W12-140 on the ground
floor of the Department of Transportation West Building, 1200 New
Jersey Avenue SE., Washington, DC 20590, between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays.

FOR FURTHER INFORMATION CONTACT: If you have questions on this rule,
call or email LCDR Gregory Knoll, Waterways Management Division Chief,
Sector Hampton Roads, Coast Guard; telephone<PHONE_NUMBER>, email
<EMAIL_ADDRESS>If you have questions on viewing or
submitting material to the docket, call Cheryl Collins, Program
Manager, Docket Operations, telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Table of Acronyms

DHS Department of Homeland Security
FR Federal Register
NPRM Notice of Proposed Rulemaking

A. Regulatory History and Information

    SKW Constructors are building a second span for the Midtown Tunnel
between Portsmouth and Norfolk, VA and will be conducting operations
that require closures of the federal channel beginning in February
2015. A Notice of Proposed Rulemaking (NPRM) was published on August
25, 2014 in the Federal Register (79 FR 50571).
    The Coast Guard received one comment on the NPRM, which is
addressed below in Section C. No request for a public meeting was
received, and no meeting was held.
    The original Temporary Final Rule, docket number [USCG-2014-0693]
was published on November 12, 2014 in the Federal Register (79 FR
67063). Due to unforeseen construction delays, the channel closure
dates had to be shifted back, prompting the issuance of the instant
Temporary Final Rule.

B. Basis and Purpose

    The legal basis for the rule is the Coast Guard's authority to
establish regulated navigation areas and other limited access areas: 33
U.S.C. 1231; 46 U.S.C. Chapter 701, 3306, 3703; 50 U.S.C. 191, 195; 33
CFR 1.05-1, 6.04-1, 6.04-6, 160.5; Pub. L. 107-295, 116 Stat. 2064;
Department of Homeland Security Delegation No. 0170.1.
    Due to increased vehicle traffic in the Hampton Roads area, SKW
Constructors, in concert with Elizabeth River Crossings and the
Virginia Department of Transportation, is constructing a second tunnel
parallel to the existing Midtown Tunnel between Portsmouth and Norfolk,
VA. The construction will involve submerging elements of the new
Midtown Tunnel. The presence of working vessels and the inability to
maneuver submerged equipment necessitate closures of the federal
channel. The closures will be in effect for 10 48-hour periods to allow
SKW Constructors to install the segments of the tunnel that overlap the
federal channel.
    The Coast Guard is establishing a safety zone in the portion of the

Elizabeth River between Elizabeth River Channel Buoy 31 (LLNR 9835) and
Elizabeth River Channel Buoy 34 (LLNR 9855). The first of the 10
scheduled closures will begin at midnight on February 18, 2015; the
final scheduled closure will begin at midnight on May 11, 2015. The
dates and hours are subject to change due to weather, scheduling
conflicts, equipment failure and other unforeseen factors. Any further
changes to these dates will be listed in the Federal Register if time
permits, and in all cases will be communicated via marine information
broadcasts.

C. Discussion of Comments, Changes, and the Final Rule

    The Coast Guard received one comment expressing concern about the
lengths of the closures and the economic impact on business operations.
The comment also requested a working group of industry members and the
Coast Guard to determine the potential impact of the closures. No
formal working group was assigned, but the Coast Guard and SKW
participated in extensive dialogues over several years with a wide
range of port partners and interested parties including, but not
limited to, the Virginia Maritime Association, Virginia Pilots
Association, Association of Virginia Docking Pilots, Independent
Docking Pilots, and U.S. Navy. In addition to being discussed at
meetings exclusively pertaining to the Midtown Tunnel, the topic has
been on the agenda at multiple Area Maritime Security Committee and
Maritime Transportation System Planning Subcommittee meetings, at which
port partners, including industry representatives, were afforded the
opportunity to discuss the potential impact of the closures.
    The decision to close the channel for 10 periods of 48 hours in
length comes as a result of these extensive and widespread discussions,
which have been occurring since the earliest proposals for the project
in 2007. Every effort has been made to reduce the length of time the
channel is closed and any adverse impacts resulting therefrom. Based on
these efforts, it was determined that 10 closures of 48 hours in length
constitutes the best available means to complete the project. Further,
10 separate closures, rather than one extended closure, will enable SKW
to complete the work while enabling traffic to flow between the closure
periods, making it the least burdensome and best available plan.
    The NPRM published on August 25, 2014 stated that the first channel
closure would begin on January 1, 2015. The first closure will actually
begin on February 18, 2015 at midnight. This change is reflected in the
instant Final Rule.
    The Captain of the Port of Hampton Roads is establishing a safety
zone in the portion of the Elizabeth River between Elizabeth River
Channel Buoy 31 (LLNR 9835) and Elizabeth River Channel Buoy 34 (LLNR
9855). The zone will be effective for 10 periods of 48 hours in length,
with each respective period beginning at midnight on February 18,
February 23, February 26, March 3, March 9, April 20, April 23, April
27, April 30, and May 11, 2015. The dates and hours are subject to
further change due to weather, scheduling conflicts, equipment failure
and other unforeseen factors. Any further changes to these dates will
be listed in the Federal Register if time permits, and in all cases
will be communicated via marine information broadcasts. No person or
vessel may enter or remain in the regulated area unless authorized by
the Captain of the Port, Hampton Roads or his designated
Representative.

D. Regulatory Analyses

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

1. Regulatory Planning and Review

    This rule is not a significant regulatory action under section 3(f)
of Executive Order 12866, Regulatory Planning and Review, as
supplemented by Executive Order 13563, Improving Regulation and
Regulatory Review, and does not require an assessment of potential
costs and benefits under section 6(a)(3) of Executive Order 12866 or
under section 1 of Executive Order 13563. The Office of Management and
Budget has not reviewed it under those orders. Although this regulation
restricts access to the safety zone, the effect of this rule will not
be significant because: (i) The safety zone will be in effect for a
limited duration; (ii) the zone is of limited size; and (iii) the Coast
Guard will make notifications via maritime advisories so mariners can
adjust their plans accordingly.

2. Impact on Small Entities

    The Regulatory Flexibility Act of 1980 (RFA), 5 U.S.C. 601-612, as
amended, requires federal agencies to consider the potential impact of
regulations on small entities during rulemaking. 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. 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. The rule may affect the following entities, some of
which might be small entities: The owners or operators of vessels
intending to transit or anchor in the specified portion of the
Elizabeth River during the specified dates and times.
    This safety zone will not have a significant economic impact on a
substantial number of small entities for the following reasons: (i) The
safety zone will only be in place for a limited duration; and (ii)
before the enforcement period, maritime advisories will be issued
allowing mariners to adjust their plans accordingly.

3. Assistance for Small Entities

    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Public Law 104-121), we want to assist small
entities in understanding this rule. If the rule would affect your
small business, organization, or governmental jurisdiction and you have
questions concerning its provisions or options for compliance, please
contact the person listed in the FOR FURTHER INFORMATION CONTACT,
above. 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). 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.

4. Collection of Information

    This rule will not call for a new collection of information under
the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

5. Federalism

    A rule has implications for federalism under Executive Order 13132,
Federalism, if it has a substantial direct effect on State or local
governments and would either preempt State law or impose a substantial
direct cost of

compliance on them. We have analyzed this rule under that Order and
have determined that it does not have implications for federalism.

6. Protest Activities

    The Coast Guard respects the First Amendment rights of protesters.
Protesters are asked to contact the person listed in the FOR FURTHER
INTFORMATION CONTACT section to coordinate protest activities so that
your message can be received without jeopardizing the safety or
security of people, places or vessels.

7. 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. Though this rule will not result in
such an expenditure, we do discuss the effects of this rule elsewhere
in this preamble.

8. Taking of Private Property

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

9. 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.

10. 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.

11. 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.

12. Energy Effects

    This action is not a ``significant energy action'' under Executive
Order 13211, Actions Concerning Regulations That Significantly Affect
Energy Supply, Distribution, or Use.

13. Technical Standards

    This rule does not use technical standards. Therefore, we did not
consider the use of voluntary consensus standards.

14. 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 determined
this action is one of a category of actions which do not individually
or cumulatively have a significant effect on the human environment.
This rule involves establishing a safety zone. This rule is
categorically excluded from further review under paragraph (34)(g) of
Figure 2-1 of the Commandant Instruction. An environmental analysis
checklist supporting this determination and a Categorical Exclusion
Determination are available in the docket where indicated under
ADDRESSES. We seek any comments or information that may lead to the
discovery of a significant environmental impact from this rule.

List of Subjects in 33 CFR Part 165

    Harbors, Marine safety, Navigation (water), Reporting and
recordkeeping requirements, Security measures, and Waterways.

    For the reasons discussed in the preamble, the Coast Guard amends
33 CFR part 165 as follows:

PART 165--REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS

0
1. The authority citation for part 165 continues to read as follows:

    Authority: 33 U.S.C. 1231; 46 U.S.C. Chapter 701; 3306, 3703; 50
U.S.C. 191, 195; 33 CFR 1.05-1, 6.04-1, 6.04-6 and 160.5; Pub. L.
107-295, 116 Stat. 2064; Department of Homeland Security Delegation
No. 0170.1.

0
2. Add Sec.  165.T05-1032 to read as follows:

Sec.  165.T05-1032  Safety Zone, Elizabeth River; Portsmouth, VA.

    (a) Definitions. For the purposes of this section, Captain of the
Port means the Commander, Sector Hampton Roads. Representative means
any Coast Guard commissioned, warrant or petty officer who has been
authorized to act on the behalf of the Captain of the Port.
    (b) Location. The following area is a safety zone: specified waters
of the Captain of the Port Sector Hampton Roads zone, as defined in 33
CFR 3.25-10: The marked channel of the Elizabeth River between
Elizabeth River Channel Buoy 31 (LLNR 9835) and Elizabeth River Channel
Buoy 34 (LLNR 9855).
    (c) Regulations. (1) In accordance with the general regulations in
Sec.  165.23 of this part, entry into this zone is prohibited unless
authorized by the Captain of the Port, Hampton Roads or his designated
Representative.
    (2) The operator of any vessel in the immediate vicinity of this
safety zone shall:
    (i) Contact on scene contracting vessels via VHF channel 13 and 16
for passage instructions.
    (ii) If on scene proceed as directed by any commissioned, warrant
or petty officer on shore or on board a vessel that is displaying a
U.S. Coast Guard Ensign.
    (3) The Captain of the Port, Hampton Roads can be reached through
the Sector Duty Officer at Sector Hampton Roads in Portsmouth, Virginia
at telephone number<PHONE_NUMBER>.
    (4) The Coast Guard Representatives enforcing the safety zone can
be contacted on VHF-FM marine band radio channel 13 (165.65Mhz) and
channel 16 (156.8 Mhz).
    (d) Enforcement period. This section will be enforced for 10
periods of 48 hours in length beginning at midnight on February 18,
February 23, February 26, March 3, March 9, April 20, April 23, April
27, April 30, and May 11, 2015. Any deviations from these times will be
communicated via marine information broadcasts.

    Dated: December 8, 2014.
Christopher S. Keane,
Captain, U.S. Coast Guard, Captain of the Port Hampton Roads.
[FR Doc. 2014-29850 Filed 12-19-14; 8:45 am]
BILLING CODE 9110-04-P


Comment Info: =================

General Comment:A 75 day period time to review the proposed regulations is insufficient. We are requesting that the review period be extended to 180 days.