[Federal Register Volume 77, Number 146 (Monday, July 30, 2012)]
[Rules and Regulations]
[Pages 44466-44468]
[FR Doc No: 2012-18563]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket Number USCG-2012-0431]
RIN 1625-AA00

Safety Zone, Atlantic Intracoastal Waterway; Oak Island, NC

AGENCY: Coast Guard, DHS.

ACTION: Temporary final rule.

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SUMMARY: The Coast Guard is establishing a temporary safety zone on the
waters of the Atlantic Intracoastal Waterway at Oak Island, North
Carolina. The safety zone is necessary to provide for the safety of
mariners on navigable waters during maintenance of the NC 133 Fixed
Bridge crossing the Atlantic Intracoastal Waterway, mile 311.8, at Oak
Island, North Carolina. The safety zone will temporarily restrict
vessel movement.

DATES: This rule is effective from September 12, 2012 until December
12, 2012 and will be enforced from 8 a.m. on September 12, 2012 until 8
p.m. on December 12, 2012.

ADDRESSES: Documents mentioned in this preamble are part of docket
[USCG-2012-0431]. 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 CWO4 Joseph M. Edge, U.S. Coast Guard Sector North
Carolina; telephone<PHONE_NUMBER>, email<EMAIL_ADDRESS>If you
have questions on viewing or submitting material to the docket, call
Renee V. Wright, Program Manager, Docket Operations, telephone (202)
366-9826.

SUPPLEMENTARY INFORMATION:

Table of Acronyms

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

A. Regulatory History and Information

    On June 15, 2012 a Notice of Proposed Rule Making (NPRM) was
published in 77 FR 35906. We received no comments on the proposed rule.
No public meeting was requested, and none was held.

B. Basis and Purpose

    The legal basis for this rule is 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; PubLIC LAW 107-295, 116 Stat. 2064; Department of Homeland
Security Delegation No. 0170.1. which collectively authorize the Coast
Guard to define regulatory safety zones.
    North Carolina Department of Transportation has awarded a contract
to Marine Contracting Corporation of Virginia Beach, Virginia to
perform bridge maintenance on the NC 133 Fixed Bridge crossing the
Atlantic Intracoastal Waterway, mile 311.8, at Oak Island, North
Carolina. The contract provides for replacing the fender system to
commence on September 12, 2012 with a completion date of December 12,
2012. The contractor will utilize a 140 foot deck barge with a 40 foot
beam as a work platform and for equipment staging. The safety zone will
provide a safety buffer to transiting vessels as bridge repairs present
potential hazards to mariners and property due to reduction of
horizontal clearance. During this period the Coast Guard will require a
one hour notification to the work supervisor at the NC 133 Fixed Bridge
at the Atlantic Intracoastal Waterway crossing, mile 311.8, Oak Island,
North Carolina. The notification requirement will be applicable during
the maintenance period for vessels requiring a horizontal clearance of
greater than 50 feet.

C. Discussion of Comments, Changes and the Final Rule

    We received no comments on the proposed rule. No public meeting was
requested, and none was held.
    The temporary safety zone will encompass the waters directly under
the NC 133 Fixed Bridge crossing the Atlantic Intracoastal Waterway,
mile 311.8, at Oak Island, North Carolina (33[deg]55'18'' N/
078[deg]04'22'' W). All vessels transiting this section of the waterway
requiring a horizontal clearance of greater than 50 feet will be
required to make a one hour advanced notification to the work
supervisor at the NC 133 Fixed Bridge while the safety zone is in
effect. This zone will be in effect and enforced from 8 a.m. September
12, 2012 through 8 p.m. December 12, 2012.

D. Regulatory Analyses

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

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. This rule does restrict
traffic from transiting a portion of the Atlantic Intracoastal
Waterway; it imposes a one hour notification to ensure the waterway is
clear of impediment to allow passage to vessels requiring a horizontal
clearance of greater than 50 feet.

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 Coast Guard
received no comments from the Small Business Administration on this
rule. 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. This rule would affect the following entities, some of
which may be small entities: The owners or operators of commercial tug
and barge companies, recreational and commercial fishing vessels
intending to transit the specified portion of Atlantic Intracoastal
Waterway from 8 a.m. September 12, 2012 through 8 p.m. December 12,
2012.
    This safety zone would not have a significant economic impact on a
substantial number of small entities for the following reasons.
Although the safety zone will apply to this section of the Atlantic
Intracoastal Waterway, vessel traffic will be able to request passage
by providing a one hour advanced notification. Before the

effective period, the Coast Guard will issue maritime advisories widely
available to the users of the waterway.

3. Assistance for Small Entities

    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104-121), we want to assist small
entities in understanding 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 the States, on the
relationship between the national government and the States, or on the
distribution of power and responsibilities among the various levels of
government. We have analyzed this rule under that Order and determined
that this rule 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
INFORMATION 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 cause 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
that this action is one of a category of actions that do not
individually or cumulatively have a significant effect on the human
environment. This rule involves the establishment of a temporary 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, 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, 160.5; Public Law
107-295, 116 Stat. 2064; Department of Homeland Security Delegation
No. 0170.1.

0
2. Add temporary Sec.  165.T05-0431 to read as follows:

Sec.  165.T05-0431  Safety Zone; Atlantic Intracoastal Waterway, Oak
Island, NC.

    (a) Regulated Area. The following area is a safety zone: This zone
includes the waters directly under and 100 yards either side of the NC
133 Fixed Bridge crossing the Atlantic Intracoastal Waterway, mile
311.8, at Oak Island, North Carolina (33[deg]55'18'' N/078[deg]04'22''
W).
    (b) Regulations. The general safety zone regulations found in 33
CFR 165.23 apply to the safety zone created by this temporary section,
Sec.  165.T05-0431. In addition the following regulations apply:
    (1) All vessels requiring greater than 50 feet horizontal clearance
are prohibited from entering this zone, except as authorized by the
Coast Guard Captain of the Port North Carolina. All other vessels are
required to transit the zone at no wake speeds.
    (2) All vessels requiring greater than 50 feet horizontal clearance
to safely

transit through the NC 133 Fixed Bridge crossing the Atlantic
Intracoastal Waterway, mile 311.8, at Oak Island, North Carolina must
contact the work supervisor on VHF-FM marine band radio channels 13 and
16 one hour in advance of intended transit.
    (3) All Coast Guard assets enforcing this safety zone can be
contacted on VHF-FM marine band radio channels 13 and 16.
    (4) The operator of any vessel within or in the immediate vicinity
of this safety zone shall:
    (i) Stop the vessel immediately upon being directed to do so by any
commissioned, warrant or petty officer on board a vessel displaying a
Coast Guard Ensign, and
    (ii) Proceed as directed by any commissioned, warrant or petty
officer on board a vessel displaying a Coast Guard Ensign.
    (c) Definitions. (1) Captain of the Port North Carolina means the
Commander, Coast Guard Sector North Carolina or any Coast Guard
commissioned, warrant or petty officer who has been authorized by the
Captain of the Port to act on his behalf.
    (2) Designated representative means any Coast Guard commissioned,
warrant, or petty officer who has been authorized by the Captain of the
Port North Carolina to assist in enforcing the safety zone described in
paragraph (a) of this section.
    (d) Enforcement. The U.S. Coast Guard may be assisted by Federal,
State and local agencies in the patrol and enforcement of the zone.
    (e) Enforcement period. This section will be enforced from 8 a.m.
September 12, 2012 through 8 p.m. December 12, 2012 unless cancelled
earlier by the Captain of the Port.

    Dated: July 19, 2012.
A. Popiel,
Captain, U.S. Coast Guard, Captain of the Port Sector North Carolina.
[FR Doc. 2012-18563 Filed 7-27-12; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register: June 2, 2008 (Volume 73, Number 106)]
[Rules and Regulations]
[Page 31363-31366]
[DOCID:fr02jn08-7]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket No. USCG-2008-0341]
RIN 1625-AA00

Safety Zone; Piscataqua River, Portsmouth, NH, and Kittery, ME;
Frontier Sentinel 2008

AGENCY: Coast Guard, DHS.

ACTION: Temporary final rule.

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SUMMARY: The Coast Guard is establishing temporary moving safety zones
around Coast Guard and Navy vessels as well as five fixed safety zones
off to the west and south of Gerrish Island, south of Kittery Point,
east of Jaffrey Point, and east of Odiornes Point during the Frontier
Sentinel Exercise on the Piscataqua River, a homeland security exercise
that will involve underwater equipment and operations. This rule will
establish multiple fixed and moving safety zones that will be enforced
from 8 a.m. to 5 p.m. daily on June 9, 2008 through June 12, 2008 from
the General Sullivan Bridge, U.S. Route 16 to one mile seaward of the
Red ``2KR'' buoy at the mouth of the river. This action is necessary to
protect federal, state, and local assets (including unmanned underwater
vehicles (UUV)) and others in the maritime community from the safety
hazards that may arise from this large scale exercise.

DATES: This rule is effective from 8 a.m. on June 9, 2008 through 5
p.m. on June 12, 2008.

ADDRESSES: Comments and material received from the public, as well as
documents mentioned in this preamble as being available in the docket,
are part of docket USCG-2008-0341 and are available online at
www.regulations.gov. This material is also available for inspection or
copying at two locations: the Docket Management Facility (M-30), U.S.
Department of Transportation, West Building Ground Floor, Room W12-140,
1200 New Jersey Avenue, SE., Washington, DC 20590, between 9 a.m. and 5
p.m., Monday through Friday, except Federal holidays and at U.S. Coast
Guard Sector Northern New England, 259 High Street, South Portland, ME
04106 between the hours of 8 a.m. and 4 p.m., Monday through Friday,
except Federal holidays.

FOR FURTHER INFORMATION CONTACT: LTJG Kevin Miller at<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Regulatory Information

    We did not publish a notice of proposed rulemaking (NPRM) for this
regulation. Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good
cause exists for not publishing a NPRM. In conjunction with
preparations for this exercise, the U.S. Navy and Coast Guard were not
able to finalize the exercise scope, location, and timetables until
April 23, 2008. Therefore, publishing of a proposed rule was not
feasible. Nonetheless, the temporary establishment of the safety zones
established by this rule is in the public interest.
    For the same reasons, under 5 U.S.C. 553(d)(3), the Coast Guard
finds that good cause exists for making this rule effective less than
30 days after publication in the Federal Register. Immediately
implementing this rule promotes the public interest by protecting the
maritime public and agency participants on the Piscataqua River during
Frontier Sentinel 2008.

Background and Purpose

    This rule establishes five fixed safety zones as well as moving
safety zones for the duration of the exercise. The rule is necessary to
protect the federal, state, local, and public entities on the
Piscataqua River during Frontier Sentinel 2008, a large scale mine
countermeasures exercise. The exercise area will encompass all waters
of the Piscataqua River from the General Sullivan Bridge, U.S. Route
16, seaward to one mile past the Red ``2KR'' buoy at the mouth of the
river. Within this exercise area, there will be numerous federal,
state, and local vessels participating with divers and unmanned
underwater vehicles (UUV). The UUV's will be monitored by Coast Guard,
Navy, or state patrol vessels, designated with the blue and white Alpha
(Diver Down) Flag.

Discussion of Rule

    The five fixed safety zones will be established where continuous
diving operations will take place during the hours of the exercise.
These fixed safety zones will be located near Gerrish Island, Kittery
Point, Jaffrey Point, and Odiornes Point. The five temporary fixed
safety zones will be enforced between the hours of 8 a.m. to 5 p.m. on
June 9, 2008 through June 12, 2008:
    All waters on the Piscataqua River enclosed by a box starting from
a point located south of Kittery Point at latitude 43[deg]04'41'' N,
longitude 70[deg]43'03'' W; thence to latitude 43[deg]04'36'' N,
longitude 70[deg]43'02'' W; thence to latitude 43[deg]04'40'' N,
longitude 70[deg]42'34'' W; thence to latitude 43[deg]04'45'' N,
longitude 70[deg]42'36'' W; thence to the point of beginning.
    All waters on the Piscataqua River enclosed by a box starting from
a point located east of Jaffrey Point at latitude 43[deg]03'48'' N,
longitude 70[deg]42'36'' W; thence to latitude 43[deg]03'15'' N,
longitude 70[deg]42'39'' W; thence to latitude 43[deg]03'15'' N,
longitude 70[deg]42'21'' W; thence to latitude 43[deg]03'48'' N,
longitude 70[deg]42'28'' W; thence to the point of beginning.
    All waters on the Piscataqua River enclosed by a box starting from
a point located west of Gerrish Island at latitude 43[deg]04'32'' N,
longitude 70[deg]42'09'' W; thence to latitude 43[deg]04'13'' N,
longitude 70[deg]42'05'' W; thence to latitude 43[deg]03'55'' N,
longitude 70[deg]42'04'' W; thence to latitude 43[deg]03'59'' N,
longitude 70[deg]41'53'' W; thence to latitude 43[deg]04'15'' N,
longitude 70[deg]41'56'' W; thence to the point of beginning.
    All waters on the Piscataqua River enclosed by a box starting from
a point located east of Odiornes Point at latitude 43[deg]03'05'' N,
longitude 70[deg]42'45'' W; thence to latitude 43[deg]02'32'' N,
longitude 70[deg]42'33'' W; thence to latitude 43[deg]02'40'' N,
longitude 70[deg]42'34'' W; thence to latitude 43[deg]02'40'' N,
longitude 70[deg]42'05'' W; thence to latitude

43[deg]02'53'' N, longitude 70[deg]42'19'' W; thence to the point of
beginning.
    All waters on the Piscataqua River enclosed by a box starting from
a point located south of Gerrish Island at latitude 43[deg]03'21'' N,
longitude 70[deg]41'24'' W; thence to latitude 43[deg]02'46'' N,
longitude 70[deg]41'13'' W; thence to latitude 43[deg]02'46'' N,
longitude 70[deg]39'27'' W; thence to latitude 43[deg]03'32'' N,
longitude 70[deg]40'10'' W; thence to latitude 43[deg]03'27'' N,
longitude 70[deg]40'28'' W; thence to the point of beginning.
    All coordinates for these safety zones are North American Datum
1983 (NAD 83).
    The temporary moving safety zones will be established as necessary
to encompass Coast Guard, Navy, and state patrol vessels, with a radius
of 100 yards, to ensure the safety of the maritime public from the
hazards associated with the UUV operations. There may be as many as
five simultaneous moving safety zones throughout the operation area.
The establishment and enforcement of these zones will be announced via
a Broadcast Notice to Mariners during the exercise timeframe. These
vessels and their associated UUV's will be operating in the Piscataqua
River from the General Sullivan, U.S. Route 16 bridge, seaward to the
mouth of the river near one mile past the Red ``2KR'' Buoy. The vessels
will be displaying an Alpha (Diver Down) Flag.
    Mariners wishing to transit through the moving safety zones must
contact the Captain of the Port (COTP) or the COTP's designated
representative at telephone number<PHONE_NUMBER> or contact the
designated Patrol Commander on VHF Channel 13 (156.7 MHz) or VHF
channel 16 (156.8 MHz) to seek permission to do so. If permission is
granted, all persons and vessels must comply with the instructions
provided by the COTP or the COTP's designated representative.

Regulatory Evaluation

    This rule is not a ``significant regulatory action'' under section
3(f) of Executive Order 12866, Regulatory Planning and Review, and does
not require an assessment of potential costs and benefits under section
6(a)(3) of that Order. The Office of Management and Budget has not
reviewed it under that Order. The Coast Guard expects the economic
impact of this rule to be so minimal that a full regulatory evaluation
is unnecessary. The effect of this rule will not be significant for the
following reasons: The safety zone will be of limited duration. The
event is designed to avoid, as much as practicable, deep draft,
fishing, and recreational boating traffic routes. Vessels may be
authorized to transit the zone with permission of the COTP.
Additionally, maritime advisories will be broadcast during the duration
of the effective period. Extensive outreach has been conducted through
the Area Maritime Security Committee, the Area Committee, and the Maine
and New Hampshire Port Safety Forum, as well as focused outreach to key
stakeholders.

Small Entities

    Under the Regulatory Flexibility Act (5 U.S.C. 601-612), we have
considered whether this rule would have a significant economic impact
on a substantial number of small entities. The term ``small entities''
comprises small businesses, not-for-profit organizations that are
independently owned and operated and are not dominant in their fields,
and governmental jurisdictions with populations of less than 50,000.
    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.
    This rule may affect the following entities, some of which may be
small entities: The owners or operators of vessels intending to transit
in the safety zone during this exercise. However, this rule will not
have a significant economic impact on a substantial number of small
entities due to the minimal time that vessels will be restricted from
the area, the ample space available for vessels to maneuver and
navigate around the zone, and advance notifications will be made to the
local community by marine information broadcasts.

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 temporary rule so that they can better
evaluate its effects on them and participate in the rulemaking process.
If this rule will affect your small business, organization or
governmental jurisdiction and you have questions concerning its
provisions or options for compliance, please contact LTJG Kevin Miller
at<PHONE_NUMBER>, Sector Northern New England, Waterways Management
Division.
    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.

Collection of Information

    This rule calls for no new collection of information under the
Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

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.

Unfunded Mandates Reform Act

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

Taking of Private Property

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

Civil Justice Reform

    This 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.

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.

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.

Energy Effects

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

Technical Standards

    The National Technology Transfer and Advancement Act (NTTAA) (15
U.S.C. 272 note) directs agencies to use voluntary consensus standards
in their regulatory activities unless the agency provides Congress,
through the Office of Management and Budget, with an explanation of why
using these standards would be inconsistent with applicable law or
otherwise impractical. Voluntary consensus standards are technical
standards (e.g., specifications of materials, performance, design, or
operation; test methods; sampling procedures; and related management
systems practices) that are developed or adopted by voluntary consensus
standards bodies.
    This rule does not use technical standards. Therefore, we did not
consider the use of voluntary consensus standards.

Environment

    We have analyzed this rule under Commandant Instruction M16475.lD
which guides the Coast Guard in complying with the National
Environmental Policy Act of 1969 (NEPA) (42 U.S.C. 4321-4370f), and
have concluded that there are no factors in this case that would limit
the use of a categorical exclusion under section 2.B.2 of the
Instruction. Therefore, this rule is categorically excluded, under
figure 2-1, paragraph (34)(g), of the Instruction, from further
environmental documentation. A final ``Environmental Analysis
Checklist'' and a final ``Categorical Exclusion Determination'' will be
available in the docket where indicated under ADDRESSES.

List of Subjects in 33 CFR Part 165

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

0
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. 1226, 1231; 46 U.S.C. 701; 50 U.S.C. 191,
195; 33 CFR 1.05-1, 6.04-1, 6.04-6, and 160.5; Public Law 107-295,
116 Stat. 2064; Department of Homeland Security Delegation No.
0170.1.

0
2. Add temporary Sec.  165.T01-0341 to read as follows:

Sec.  165.T01-0341  Safety Zone; Piscataqua River, Portsmouth, NH, and
Kittery, ME; Frontier Sentinel 2008.

    (a) Location. The following areas are fixed safety zones:
    (1) All waters on the Piscataqua River enclosed by a box starting
from a point located south of Kittery Point at latitude
43[deg]04[min]41[sec] N, longitude 70[deg]43[min]03[sec] W; thence to
latitude 43[deg]04[min]36[sec] N, longitude 70[deg]43[min]02[sec] W;
thence to latitude 43[deg]04[min]40[sec] N, longitude
70[deg]42[min]34[sec] W; thence to latitude 43[deg]04[min]45[sec] N,
longitude 70[deg]42[min]36[sec] W; thence to the point of beginning.
    (2) All waters on the Piscataqua River enclosed by a box starting
from a point located east of Jaffrey Point at latitude
43[deg]03[min]48[sec] N, longitude 70[deg]42[min]36[sec] W; thence to
latitude 43[deg]03[min]15[sec] N, longitude 70[deg]42[min]39[sec] W;
thence to latitude 43[deg]03[min]15[sec] N, longitude
70[deg]42[min]21[sec] W; thence to latitude 43[deg]03[min]48[sec] N,
longitude 70[deg]42[min]28[sec] W; thence to the point of beginning.
    (3) All waters on the Piscataqua River enclosed by a box starting
from a point located west of Gerrish Island at latitude
43[deg]04[min]32[sec] N, longitude 70[deg]42[min]09[sec] W; thence to
latitude 43[deg]04[min]13[sec] N, longitude 70[deg]42[min]05[sec] W;
thence to latitude 43[deg]03[min]55[sec] N, longitude
70[deg]42[min]04[sec] W; thence to latitude 43[deg]03[min]59[sec] N,
longitude 70[deg]41[min]53[sec] W; thence to latitude
43[deg]04[min]15[sec] N, longitude 70[deg]41[min]56[sec] W; thence to
the point of beginning.
    (4) All waters on the Piscataqua River enclosed by a box starting
from a point located east of Odiornes Point at latitude
43[deg]03[min]05[sec] N, longitude 70[deg]42[min]45[sec] W; thence to
latitude 43[deg]02[min]32[sec] N, longitude 70[deg]42[min]33[sec] W;
thence to latitude 43[deg]02[min]40[sec] N, longitude
70[deg]42[min]34[sec] W; thence to latitude 43[deg]02[min]40[sec] N,
longitude 70[deg]42[min]05[sec] W; thence to latitude
43[deg]02[min]53[sec] N, longitude 70[deg]42[min]19[sec] W; thence to
the point of beginning.
    (5) All waters on the Piscataqua River enclosed by a box starting
from a point located south of Gerrish Island at latitude
43[deg]03[min]21[sec] N, longitude 70[deg]41[min]24[sec] W; thence to
latitude 43[deg]02[min]46[sec] N, longitude 70[deg]41[min]13[sec] W;
thence to latitude 43[deg]02[min]46[sec] N, longitude
70[deg]39[min]27[sec] W; thence to latitude 43[deg]03[min]32[sec] N,
longitude 70[deg]40[min]10[sec] W; thence to latitude
43[deg]03[min]27[sec] N, longitude 70[deg]40[min]28[sec] W; thence to
the point of beginning.
    (6) All vessels and swimmers are restricted from entering these
areas.
    (b) Location. The following areas are moving safety zones:
    (1) All waters on the Piscataqua River in a moving 100 yard radius
surrounding United States Navy, Coast Guard, and state vessels
displaying an Alpha (Diver Down) Flag from the General Sullivan Bridge,
U.S. Route 16, to one mile past the Red ``2KR'' Buoy.
    (2) All vessels and swimmers are restricted from entering these
areas.
    (c) Effective Date. This rule is effective from 8 a.m. on June 9,
2008 through 5 p.m. June 12, 2008, and will be enforced from 8 a.m. to
5 p.m. daily during that period.
    (d) Definitions.
    (1) Designated Representative means a Coast Guard Patrol Commander,
including a Coast Guard coxswain, petty officer, or other officer
operating a Coast Guard vessel and a Federal, State, or local law
enforcement officer designated by or assisting the Captain of the Port
(COTP).
    (2) [Reserved]
    (e) Regulations.
    (1) In accordance with the general regulations in 165.23 of this
part, entry into or movement within this zone by any person or vessel
is prohibited unless authorized by the COTP, Sector Northern New
England or the COTP's designated representative.
    (2) Vessel operators desiring to enter or operate within the safety
zones may contact the COTP or the COTP's designated representative at
telephone number<PHONE_NUMBER> or designated representative on VHF
Channel 13 (156.7 MHz) or VHF channel 16 (156.8 MHz)to seek permission
to do so. If permission is granted, all persons and

vessels must comply with the instructions provided by the COTP or the
COTP's designated representative.

    Dated: May 20, 2008.
J.E. Rendon,
Captain, U.S. Coast Guard, COTP Northern New England.
 [FR Doc. E8-12175 Filed 5-30-08; 8:45 am]

BILLING CODE 4910-15-P


[Federal Register Volume 78, Number 103 (Wednesday, May 29, 2013)]
[Rules and Regulations]
[Pages 32157-32161]
[FR Doc No: 2013-12457]

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

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2012-0461; FRL-9385-9]

Methyl 5-(dimethylamino)-2-methyl-5-oxopentanoate; Exemption from
the Requirement of a Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

SUMMARY: This regulation establishes an exemption from the requirement
of a tolerance for residues of methyl 5-(dimethylamino)-2-methyl-5-
oxopentanoate (1174627-68-9) when used as an inert ingredient solvent
in

pesticide formulations applied to growing crops or to raw agricultural
commodities after harvest. SciReg, Inc. (12733 Director's Loop,
Woodbridge, VA 22192), on behalf of Rhodia Inc. (CN 7500, 8 Cedar Brook
Drive, Cranbury, NJ 08512-7500) submitted a petition to EPA under the
Federal Food, Drug, and Cosmetic Act (FFDCA), requesting establishment
of an exemption from the requirement of a tolerance. This regulation
eliminates the need to establish a maximum permissible level for
residues of methyl 5-(dimethylamino)-2-methyl-5-oxopentanoate.

DATES: This regulation is effective May 29, 2013. Objections and
requests for hearings must be received on or before July 29, 2013, 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: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPP-2012-0461. All documents in the
docket are available at http://www.regulations.gov or at the Office of
Pesticide Programs Regulatory Public Docket (OPP Docket) in the
Environmental Protection Agency Docket Center (EPA/DC), EPA West Bldg.,
Rm. 3334, 1301 Constitution Ave. NW., Washington, DC 20460-0001. The
Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through
Friday, excluding legal holidays. The telephone number for the Public
Reading Room is<PHONE_NUMBER>, and the telephone number for the OPP
Docket is<PHONE_NUMBER>. Please review the visitor instructions and
additional information about the docket available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Mark Dow, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone
number:<PHONE_NUMBER>; email 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.
The following list of North American Industrial Classification System
(NAICS) codes is not intended to be exhaustive, but rather provides a
guide to help readers determine whether this document applies to them.
Potentially affected entities may include:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).

B. How can I get electronic access to other related information?

    You may access a frequently updated electronic version of 40 CFR
part 180 through the Government Printing Office's e-CFR site at http://ecfr.gpoaccess.gov/cgi/t/text/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

C. How can I file an objection or hearing request?

    Under FFDCA section 408(g), 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-2012-0461 in the subject line on the first
page of your submission. All objections and requests for a hearing must
be in writing, and must be received by the Hearing Clerk on or before
July 29, 2013. Addresses for mail and hand delivery of objections and
hearing requests are provided in 40 CFR 178.25(b).
    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 (excluding any Confidential Business Information (CBI)) for
inclusion in the public docket. Information not marked confidential
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without
prior notice. Submit the non-CBI copy of your objection or hearing
request, identified by docket ID number EPA-HQ-OPP-2012-0461, by one of
the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the online instructions for submitting comments. Do not submit
electronically any information you consider to be CBI or other
information whose disclosure is restricted by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW., Washington, DC
20460-0001.
     Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at http://www.epa.gov/dockets/contacts.html.
    Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at  http://www.epa.gov/dockets.

II. Petition for Exemption

    In the Federal Register of August 22, 2012 (77 FR 50661) (FRL-9358-
9), EPA issued a document pursuant to FFDCA section 408, 21 U.S.C.
346a, announcing the filing of a pesticide petition (PP 2E8010) by
SciReg, Inc. (12733 Director's Loop, Woodbridge, VA 22192), on behalf
of Rhodia Inc. (CN 7500, 8 Cedar Brook Drive, Cranbury, NJ 08512-7500).
The petition requested that 40 CFR 180.910 be amended by establishing
an exemption from the requirement of a tolerance for residues of methyl
5-(dimethylamino)-2-methyl-5-oxopentanoate (1174627-68-9) when used as
an inert ingredient (solvent) in pesticide formulations applied to
growing crops or to raw agricultural commodities after harvest (40 CFR
180.910). That document referenced a summary of the petition prepared
by SciReg, Inc. (12733 Director's Loop, Woodbridge, VA 22192), on
behalf of Rhodia Inc. (CN 7500, 8 Cedar Brook Drive, Cranbury, NJ
08512-7500), the petitioner, which is available in the docket, http://www.regulations.gov. There were no comments received in response to the
notice of filing.

III. Inert Ingredient Definition

    Inert ingredients are all ingredients that are not active
ingredients as defined in 40 CFR 153.125 and include, but are not
limited to, the following types of ingredients (except when they have a
pesticidal efficacy of their own): Solvents such as alcohols, and
hydrocarbons; surfactants such as polyoxyethylene polymers, and fatty
acids; carriers such as clay, and diatomaceous earth; thickeners such
as carrageenan, and modified cellulose; wetting, spreading, and
dispersing agents; propellants in aerosol dispensers;
microencapsulating agents, and emulsifiers. The term ``inert'' is not
intended to imply nontoxicity, the ingredient may or may not be
chemically active. Generally, EPA has exempted inert ingredients from
the requirement of a tolerance based on the low toxicity of the
individual inert ingredients.

IV. Aggregate Risk Assessment and Determination of Safety

    Section 408(c)(2)(A)(i) of FFDCA allows EPA to establish an
exemption from the requirement for 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 . . . .''
    EPA establishes exemptions from the requirement of a tolerance only
in those cases where it can be clearly demonstrated that the risks from
aggregate exposure to pesticide chemical residues under reasonably
foreseeable circumstances will pose no appreciable risks to human
health. In order to determine the risks from aggregate exposure to
pesticide inert ingredients, the Agency considers the toxicity of the
inert in conjunction with possible exposure to residues of the inert
ingredient through food, drinking water, and through other exposures
that occur as a result of pesticide use in residential settings. If EPA
is able to determine that a finite tolerance is not necessary to ensure
that there is a reasonable certainty that no harm will result from
aggregate exposure to the inert ingredient, an exemption from the
requirement of a tolerance may be established.
    Consistent with FFDCA section 408(c)(2)(A), and the factors
specified in FFDCA section 408(c)(2)(B), 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 methyl 5-(dimethylamino)-2-
methyl-5-oxopentanoate, including exposure resulting from the exemption
established by this action. EPA's assessment of exposures and risks
associated with methyl 5-(dimethylamino)-2-methyl-5-oxopentanoate
follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered their
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. Specific information on the studies received and the nature
of the adverse effects caused by methyl 5-(dimethylamino)-2-methyl-5-
oxopentanoate as well as the no-observed-adverse-effect-level (NOAEL)
and the lowest-observed-adverse-effect-level (LOAEL) from the toxicity
studies are discussed in this unit.
    Methyl 5-(dimethylamino)-2-methyl-5-oxopentanoate is not acutely
toxic via the oral or dermal routes of exposure. It is not a primary
eye irritant, a primary skin irritant, or a dermal sensitizer. A repeat
dose reproduction/developmental toxicity study showed no treatment-
related effects on mating or fertility. There were no treatment-related
effects on gestation, litter size, litter growth, and development as
compared to controls. There was no evidence of any toxicity in the
parameters evaluated in this study. The NOAEL for systemic toxicity was
considered to be 1,000 milligram/kilograms body weight/day (mg/kg bw/
day), the highest dose tested; a LOAEL was not observed in this study.
A Bacterial Reverse Mutation Assay with Salmonella typhimurium
concluded methyl 5-(dimethylamino)-2-methyl-5-oxopentanoate did not
induce mutagenic activity. A Gene Mutation Assay with Chinese hamster
cells showed no reproducible dose-dependent increase in gene mutation
frequency. A Chromosome Aberration Test with Human Lymphocytes in vitro
showed no signs of cells carrying structural chromosomal aberrations.
There was no evidence of an increase in polyploidy metaphases after
treatment with methyl 5-(dimethylamino)-2-methyl-5-oxopentanoate. A
Mammalian Erythrocyte Micronucleus Test with mice revealed no
statistically significant decreases in the PCE/NCE ratio therefore,
methyl 5-(dimethylamino)-2-methyl-5-oxopentanoate, is considered to be
negative for genotoxicity. Methyl 5-(dimethylamino)-2-methyl-5-
oxopentanoate, is considered non-mutagenic, there are no known data
that directly suggest that methyl 5-(dimethylamino)-2-methyl-5-
oxopentanoate is carcinogenic. Based on the absence any toxicity at the
limit dose, lack of mutagenicity concerns, and lack of carcinogenicity
triggers in the Derek analysis, EPA concluded that methyl 5-
(dimethylamino)-2-methyl-5-oxopentanoate is unlikely to pose a cancer
risk at anticipated human exposures. Neurotoxicity was not observed in
a reproduction/developmental toxicity screening study in rats, where
neurotoxic parameters were evaluated. Immunotoxicity studies were not
available for review. However, signs of immunotoxicity were not
observed in any of the submitted studies.

B. Toxicological Points of Departure/Levels of Concern

    The available toxicity studies indicate that methyl 5-
(dimethylamino)-2-methyl-5-oxopentanoate has a very low overall
toxicity. The NOAEL is 1,000 mg/kg bw/day (limit dose). Since signs of
toxicity were not observed at the limit dose, an endpoint of concern
for risk assessment purposes was not identified. Therefore, since no
endpoint of concern was identified for the acute, and chronic dietary
exposure assessments, and short-, and intermediate-term dermal, and
inhalation exposure assessments, a quantitative risk assessment for
methyl 5-(dimethylamino)-2-methyl-5-oxopentanoate is not necessary.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to methyl 5-(dimethylamino)-2-methyl-5-oxopentanoate, EPA
considered exposure under the proposed exemption from the requirement
of a tolerance. EPA assessed dietary exposures from methyl 5-
(dimethylamino)-2-methyl-5-oxopentanoate in food as follows: Dietary
exposure to methyl 5-(dimethylamino)-2-methyl-5-oxopentanoate can occur
from eating food treated with pesticide formulations containing this
inert ingredient. In addition, food can pick up residues of methyl 5-
(dimethylamino)-2-methyl-5-oxopentanoate that has been used in
pesticide formulations applied to treat food contact surfaces, thus
resulting in indirect exposure. However, since an endpoint of concern
for risk assessment was not identified, a quantitative dietary exposure
assessment for methyl 5-(dimethylamino)-2-methyl-5-oxopentanoate was
not conducted.
    2. Dietary exposure from drinking water. Dietary exposure from
drinking water to methyl 5-(dimethylamino)-2-methyl-5-oxopentanoate can
occur by drinking water that has been contaminated by run-off from a
pesticide treated area, and from antimicrobial formulations used in
food-contact surface sanitizing solutions. Since an endpoint for risk
assessment was not identified, a quantitative dietary exposure
assessment from drinking

water for methyl 5-(dimethylamino)-2-methyl-5-oxopentanoate was not
conducted.
    3. From non-dietary exposure. The term ``residential exposure'' is
used in this document to refer to non-occupational, non-dietary
exposure (e.g., textiles (clothing and diapers), carpets, swimming
pools, and hard surface disinfection on walls, floors, tables).
    Methyl 5-(dimethylamino)-2-methyl-5-oxopentanoate may be used in
inert ingredients in pesticide products that are registered for
specific uses that may result in both indoor and outdoor residential
exposures. However, since there are no toxicological effects of concern
occurring below the limit dose of 1,000 mg/kg bw/day, it is not
necessary to conduct quantitative assessments of residential (non-
occupational) exposures and risks. There are no dermal or inhalation
toxicological endpoints of concern to the Agency, therefore,
quantitative assessments have not been conducted.
    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 methyl 5-(dimethylamino)-2-methyl-5-oxopentanoate
to share a common mechanism of toxicity with any other substances, and
methyl 5-(dimethylamino)-2-methyl-5-oxopentanoate does not appear to
produce a toxic metabolite produced by other substances. For the
purposes of this tolerance action, therefore, EPA has assumed that
methyl 5-(dimethylamino)-2-methyl-5-oxopentanoate 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 Web site 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 Food Quality Protection Act (FQPA) safety factor. 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 is no evidence of
qualitative or quantitative susceptibility of infants and children in
the available database.
    3. Conclusion. As part of its qualitative assessment, the Agency
did not use safety factors for assessing risk, and no additional safety
factor is needed for assessing risk to infants and children. The
available toxicity studies suggest low toxicity of methyl 5-
(dimethylamino)-2-methyl-5-oxopentanoate. The toxicity database for
methyl 5-(dimethylamino)-2-methyl-5-oxopentanoate contains acute oral,
dermal and inhalation toxicity studies; skin, eye, and sensitization
studies; mutagenicity studies (gene mutation, chromosomal aberrations
assay), including in vivo micronucleus assay; and reproduction/
developmental toxicity screening study in the rat. There is no
indication based upon the available data that methyl 5-(dimethylamino)-
2-methyl-5-oxopentanoate is a neurotoxic or immunotoxic chemical, or
results in increased qualitative or quantitative susceptibility in
infants or children. Based on this information, there is no concern, at
this time, for increased sensitivity to infants and children to this
chemical when used as inert ingredient in pesticides formulations.

E. Aggregate Risks and Determination of Safety

    Taking into consideration all available information on methyl 5-
(dimethylamino)-2-methyl-5-oxopentanoate, EPA has determined that there
is a reasonable certainty that no harm to any population subgroup will
result from aggregate exposure to methyl 5-(dimethylamino)-2-methyl-5-
oxopentanoate under reasonably foreseeable circumstances. Therefore,
the establishment of an exemption from tolerance under 40 CFR 180.910
for residues of methyl 5-(dimethylamino)-2-methyl-5-oxopentanoate when
used as an inert ingredient, specifically as a solvent, in pesticide
formulations applied to growing crops and to raw agricultural
commodities after harvest, is safe under FFDCA section 408.
    1. Aggregate cancer risk for U.S. population. For the reasons
stated in Unit IV.A. methyl 5-(dimethylamino)-2-methyl-5-oxopentanoate
is not expected to pose a cancer risk to humans.
    2. 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 methyl 5-(dimethylamino)-2-methyl-5-oxopentanoate residues
when used as an inert ingredient in pesticide formulations under 40 CFR
180.910.

V. Other Considerations

A. Analytical Enforcement Methodology

    An analytical method is not required for enforcement purposes since
the Agency is establishing an exemption from the requirement of a
tolerance without any numerical limitation.

B. International Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S.
tolerances with international standards whenever possible, consistent
with U.S. food safety standards and agricultural practices. EPA
considers the international maximum residue limits (MRLs) established
by the Codex Alimentarius Commission (Codex), as required by FFDCA
section 408(b)(4). The Codex Alimentarius is a joint United Nation Food
and Agriculture Organization/World Health Organization food standards
program, and it is recognized as an international food safety
standards-setting organization in trade agreements to which the United
States is a party. EPA may establish a tolerance that is different from
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain
the reasons for departing from the Codex level.
    The Codex has not established a MRL for Methyl 5-(dimethylamino)-2-
methyl-5-oxopentanoate.

VI. Conclusions

    Therefore, an exemption from the requirement of a tolerance is
established under 40 CFR 180.910 for methyl 5-(dimethylamino)-2-methyl-
5-oxopentanoate. (1174627-68-9) when used as an inert ingredient
(solvent) in pesticide formulations applied to growing crops and to raw
agricultural commodities after harvest.

VII. Statutory and Executive Order Reviews

    This final rule establishes an exemption from the requirement of a
tolerance under FFDCA section 408(d) 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 FFDCA section 408(d), 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 FFDCA section 408(n)(4). 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) (2 U.S.C. 1501 et seq.).
    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) (15 U.S.C. 272 note).

VIII. Congressional Review Act

    Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.),
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
the rule in the Federal Register. This action 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: May 20, 2013
Lois A. Rossi,
Director, Registration Division, Office of Pesticide Programs.
    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. In Sec.  180.910, alphabetically add the following inert ingredient
to the table to read as follows:

Sec.  180.910  Inert ingredients used pre- and post-harvest; exemptions
from the requirement of a tolerance.

* * * * *

------------------------------------------------------------------------
      Inert ingredients              Limits                 Uses
------------------------------------------------------------------------

                              * * * * * * *
Methyl 5-(dimethylamino)-2-   ....................  Solvent
 methyl-5-oxopentanoate
 (1174627-68-9).

                              * * * * * * *
------------------------------------------------------------------------

[FR Doc. 2013-12457 Filed 5-28-13; 8:45 am]
BILLING CODE 6560-50-P