[Federal Register: June 25, 2009 (Volume 74, Number 121)]
[Rules and Regulations]
[Page 30220-30224]
[DOCID:fr25jn09-6]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 100

[Docket No. USCG-2009-0430]
RIN 1625-AA08

Special Local Regulation for Marine Events; Recurring Marine
Events in the Fifth Coast Guard District

AGENCY: Coast Guard, DHS.

ACTION: Interim final rule; request for comments.

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SUMMARY: The Coast Guard is amending the list of recurring marine
events within the Fifth Coast Guard District. These regulations make
small changes to the regulated areas of two permitted marine events
listed in the table attached to the regulation. These special local
regulations are necessary to provide for the safety of life on
navigable waters during marine events. This action will restrict vessel
traffic in portions of the Chesapeake Bay and Assateague Channel,
Virginia.

DATES: This interim final rule is effective July 27, 2009. Comments and
related material must reach the Coast Guard on or before July 10, 2009.

ADDRESSES: You may submit comments identified by docket number USCG-
2009-0430 using any one of the following methods:
    (1) Federal eRulemaking Portal: http://www.regulations.gov.
    (2) Fax:<PHONE_NUMBER>.
    (3) Mail: Docket Management Facility (M-30), U.S. Department of
Transportation, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue, SE., Washington, DC 20590-0001.
    (4) Hand delivery: Same as mail address above, between 9 a.m. and 5
p.m., Monday through Friday, except Federal holidays. The telephone
number is<PHONE_NUMBER>.
    To avoid duplication, please use only one of these four methods.
See the ``Public Participation and Request for Comments'' portion of
the SUPPLEMENTARY INFORMATION section below for instructions on
submitting comments.

FOR FURTHER INFORMATION CONTACT: If you have questions on this interim
rule, call or e-mail, Dennis Sens, Project Manager, Fifth Coast Guard
District, Prevention Division,<PHONE_NUMBER> or e-mail
<EMAIL_ADDRESS>If you have questions on viewing or submitting
material to the docket, call Renee V. Wright, Program Manager, Docket
Operations, telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Public Participation and Request for Comments

    We encourage you to participate in this rulemaking by submitting
comments and related materials. All comments received will be posted,
without change, to http://www.regulations.gov and will include any
personal information you have provided.

Submitting Comments

    If you submit a comment, please include the docket number for this
rulemaking (USCG-2009-0430), indicate the specific section of this
document to which each comment applies, and provide a reason for each
suggestion or recommendation. You may submit your comments and material
online (via http://www.regulations.gov) or by fax, mail or hand
delivery, but please use only one of these means. If you submit a
comment online via http://www.regulations.gov, it will be considered
received by the Coast Guard when you successfully transmit the comment.
If you fax, hand delivery, or mail your comment, it will be considered
as having been received by the Coast Guard when it is received at the
Docket Management Facility. We recommend that you include your name and
a mailing address, an e-mail address, or a telephone number in the body
of your document so that we can contact you if we have questions
regarding your submission.
    To submit your comment online, go to http://www.regulations.gov,
select the Advanced Docket Search option on the right side of the
screen, insert ``USCG-2009-0430'' in the Docket ID box, press Enter,
and then click on the balloon shape in the Actions column. If you
submit comments by mail or hand delivery, submit them in an unbound
format, no larger than 8\1/2\ by 11 inches, suitable for copying and
electronic filing. If you submit comments by mail and would like to
know that they reached the Facility, please enclose a stamped, self-
addressed postcard or envelope. We will consider all comments and
material received during the comment period and may change this rule
based on your comments.

Viewing Comments and Documents

    To view comments, as well as documents mentioned in this preamble
as being available in the docket, go to http://www.regulations.gov,
select the Advanced Docket Search option on the right side of the
screen, insert USCG-2009-0430 in the Docket ID box, press Enter, and
then click on the item in the Docket ID column. 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. We have an agreement with the
Department of Transportation to use the Docket Management Facility.

Privacy Act

    Anyone can search the electronic form of comments received into any
of our dockets by the name of the individual submitting the comment (or
signing the comment, if submitted on behalf of an association,
business, labor union, etc.). You may review a Privacy Act notice
regarding our public dockets in the January 17, 2008, issue of the
Federal Register (73 FR 3316).

Public Meeting

    We do not now plan to hold a public meeting. But you may submit a
request for one using one of the four methods specified under
ADDRESSES. Please explain why you believe a public meeting would be
beneficial. If we determine that one would aid this rulemaking, we will
hold one at a time and place announced by a later notice in the Federal
Register.

Regulatory Information

    The Coast Guard is issuing this interim rule without prior notice
and opportunity to comment pursuant to authority under section 4(a) of
the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This
provision authorizes an agency to issue a rule without prior notice and
opportunity to comment when the agency for good cause finds that those
procedures are ``impracticable, unnecessary, or contrary to the public
interest.'' Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good
cause exists for not publishing a notice of proposed rulemaking (NPRM)
with respect to this rule because the amendments provided make only
minor changes to the regulated area and enhance the safety of life on
navigable waters during marine events.
    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. The potential dangers posed to
event participants and protected wildlife on navigable waterways by
vessel traffic makes special local regulations necessary. Delaying the
effective date would be contrary to the public interest, since
immediate action is needed to ensure the safety of the event
participants, support vessels, spectator craft and other vessels
transiting the event area. However, advance notifications will be made
to users of the affected waterways via marine information broadcasts,
local notice to mariners, commercial radio stations and area
newspapers.

Background and Purpose

    Marine events are frequently held on the navigable waters within
the boundary of the Fifth Coast Guard District. For a description of
the geographical area of each Coast Guard Sector--Captain of the Port
Zone, please see 33 CFR 3.25.
    This regulation amends two marine events listed in 33 CFR Part
100.501, Table to Sec.  100.501. They are event No. 20, The Great
Chesapeake Bay Bridges Swim Races and Chesapeake Challenge One Mile
Swim and event No. 42, Pony Penning Swim.
    Annually, the Great Chesapeake Bay Swim, Inc. sponsors the ``The
Great Chesapeake Bay Bridges Swim Races and Chesapeake Challenge One
Mile Swim'' on the waters of the Chesapeake Bay near the William P.
Lane Jr. Memorial (Chesapeake Bay) Bridge. The regulated area is a line
that runs parallel to both the north and south spans of the bridge and
includes the waters 500 yards north of the north span and 500 yards
south of the south span of the bridge. The regulated area listed in the
Table to Sec.  100.501 for event No. 20 is amended to describe the area
as follows: The waters of the Chesapeake Bay between and adjacent to
the spans of the William P. Lane Jr. Memorial Bridge shore to shore 500
yards north of the north span of the bridge from the western shore at
latitude 39[deg]00'36'' N, longitude 076[deg]23'53'' W and the eastern
shore at latitude 38[deg]59'14'' N, longitude 076[deg]20'00'' W; and
500 yards south of the south span of the bridge from the western shore
at latitude 39[deg]00'16'' N, longitude 076[deg]24'30'' W and the
eastern shore at latitude 38[deg]58'39'' N, longitude 076[deg]20'10''
W. The regulated area as described is amended to ensure the safety of
participants and support vessels and in accordance with 33 CFR 100.501
will be enforced for the duration of the marine event. Due to the need
for vessel control during the event, vessel traffic will be temporarily
restricted in this segment of the Chesapeake Bay. Under provisions of
33 CFR 100.501, during the enforcement period, vessels may not enter
the regulated area unless they receive permission from the Coast Guard
Patrol Commander. Vessel traffic may be allowed to transit the
regulated area only when the Patrol Commander determines it is safe to
do so.
    Annually, the Chincoteague Volunteer Fire Department sponsors the
``The Pony Penning Swim'' on the waters of Assateague Channel that runs
between Chincoteague and Assateague Islands. The regulated area
includes the waters of Assateague Channel from shoreline to shoreline,
bounded to the east by a line drawn from latitude 37[deg]55'00'' N,
longitude 075[deg]22'45'' W, to latitude 37[deg]54'47'' N, longitude
075[deg]22'45'' W,

and to the south by a line drawn from latitude 37[deg]54'47'' N,
longitude 075[deg]22'45'' W, to latitude 37[deg]54'47'' N, longitude
075[deg]23'04'' W. The regulated area as described, is amended to
ensure the safety of participants, wildlife and support vessels, and in
accordance with 33 CFR 100.501 will be enforced for the duration of the
marine event. Due to the need for vessel control during the event,
vessel traffic will be temporarily restricted in this segment of
Assateague Channel. Vessels may not enter the regulated area unless
they receive permission from the Coast Guard Patrol Commander.
    Specific information on each event, including the exact dates,
times and description of the regulated area, will be provided to the
public through a Local Notice to Mariners published before the event,
as well as through Broadcast Notice to Mariners. The public will also
be notified about these marine events by local newspapers, radio and
television stations. The various methods of notification provided by
the Coast Guard and local community media outlets will facilitate
informing mariners so they can adjust their plans accordingly.

Discussion of Rule

    The regulated area for ``The Great Chesapeake Bay Bridges Swim
Races and Chesapeake Challenge One Mile Swim'' is amended to correct
two reference positions incorrectly listed in the Table to Sec.
100.501, event No. 20. Specifically, the longitude that describes the
point north of the northern bridge span near the western shoreline
should have indicated 53 minutes vice 5 minutes longitude. The latitude
and longitude that describes the point south of the southern bridge
span near the eastern shoreline should have indicated 39 minutes
latitude and 10 minutes longitude vice 38.5 minutes and 6 minutes,
respectively. This action is not considered a significant change with
regard to both size of the regulated area and impact on vessels
transiting the area during the enforcement period. This rule amends
latitude and longitude points of reference that are located at the
periphery of the regulated area. The adjustments to latitude and
longitude discussed in this rule have minimal effect on the overall
size of the regulated area, particularly where it intersects charted
navigational channels. This corrective action will further enhance
safety of event participants, support vessels and local area vessels
transiting near the regulated area.
    The regulated area for ``The Chincoteague Pony Penning Swim'' is
amended to correct the description of the regulated area incorrectly
listed in the Table to Sec.  100.501, event No. 42. The regulated area
as amended by this rule adjusts the southern boundary line by moving it
approximately 400 yards to the south along the mid-line of the channel
and adjusts the eastern boundary by moving it approximately 100 yards
to the west along the mid-line of the channel. This action is not
considered a significant change with regard to both size of the
regulated area and impact on vessels transiting the area during the
enforcement period. The regulated area encompasses a remote marsh area
with relatively light vessel traffic. This corrective action will
further enhance safety of event participants, wildlife, support vessels
and local area vessels transiting near the regulated area.

Regulatory Analyses

    We developed this interim 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.

Regulatory Planning and Review

    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.
    Although this rule prevents traffic from transiting a portion of
certain waterways during specified events, the effect of this
regulation will not be significant due to the limited duration that the
regulated area will be in effect and the extensive advance
notifications that will be made to the maritime community via marine
information broadcasts, local radio stations and area newspapers so
mariners can adjust their plans accordingly. In some cases vessel
traffic may be able to transit the regulated area when the Coast Guard
Patrol Commander deems it is safe to do so.

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 would affect the following entities, some of which
might be small entities: the owners or operators of vessels intending
to transit or anchor in the areas where marine events are being held.
This regulation will not have a significant impact on a substantial
number of small entities because it will be enforced only during marine
events that have been permitted by the Coast Guard Captain of the Port.
The Captain of the Port will ensure that small entities are able to
operate in the areas where events are occurring when it is safe to do
so. In some cases, vessels will be able to safely transit around the
regulated area at various times, and, with the permission of the Patrol
Commander, vessels may transit through the regulated area. Before the
enforcement period, the Coast Guard will issue maritime advisories so
mariners can adjust their plans accordingly.
    If you think that your business, organization, or governmental
jurisdiction qualifies as a small entity and that this rule would have
a significant economic impact on it, please submit a comment (see
ADDRESSES) explaining why you think it qualifies and how and to what
degree this rule would economically affect it.

Assistance for Small Entities

    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104-121), we offer to assist small
entities in understanding the rule so that they can better evaluate its
effects on them and participate in the rulemaking process.
    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 Department of Homeland Security
Management Directive 023-01 and Commandant Instruction M16475.lD, which
guide the Coast Guard in complying with the National Environmental
Policy Act of 1969 (NEPA) (42 U.S.C. 4321-4370f), and have concluded
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 is categorically excluded, under figure 2-1, paragraph
(34)(h), of the Instruction. This rule involves implementation of
regulations within 33 CFR Part 100 that apply to organized marine
events on the navigable waters of the United States that may have
potential for negative impact on the safety or other interest of
waterway users and shore side activities in the event area. The
category of water activities includes but is not limited to sail boat
regattas, boat parades, power boat racing, swimming events, crew
racing, and sail board racing.
    Under figure 2-1, paragraph (34)(h), of the Instruction, an
environmental analysis checklist and a categorical exclusion
determination are not required for this rule.

List of Subjects in 33 CFR Part 100

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

0
For the reasons discussed in the preamble, the Coast Guard amends 33
CFR part 100 as follows:

PART 100--SAFETY OF LIFE ON NAVIGABLE WATERS

0
1. The authority citation for part 100 continues to read as follows:

    Authority:  33 U.S.C. 1233.

0
2. In Sec.  100.501, in the Table to Sec.  100.501, revise number 20
and number 42, to read as follows:

Sec.  100.501  Special Local Regulations; Marine Events in the Fifth
Coast Guard District.

* * * * *

    Table To Sec.   100.501.--All Coordinates Listed in the Table to Sec.   100.501 Reference Datum NAD 1983.
----------------------------------------------------------------------------------------------------------------
     No.               Date                Event               Sponsor                     Location
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                                     Coast Guard Sector Baltimore--COTP Zone
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                                                 * * * * * * *
20...........  June--2nd Sunday...  The Great            Great Chesapeake     The waters of the Chesapeake Bay
                                     Chesapeake Bay       Bay Swim, Inc.       between and adjacent to the spans
                                     Bridges Swim Races                        of the William P. Lane Jr.
                                     and Chesapeake                            Memorial Bridge shore to shore
                                     Challenge One Mile                        500 yards north of the north span
                                     Swim..                                    of the bridge from the western
                                                                               shore at latitude
                                                                               39[deg]00[min]36[sec] N,
                                                                               longitude 076[deg]23[min]53[sec]
                                                                               W and the eastern shore at
                                                                               latitude 38[deg]59[min]14[sec] N,
                                                                               longitude 076[deg]20[min]00[sec]
                                                                               W, and 500 yards south of the
                                                                               south span of the bridge from the
                                                                               western shore at latitude
                                                                               39[deg]00[min]16[sec] N,
                                                                               longitude 076[deg]24[min]30[sec]
                                                                               W and the eastern shore at
                                                                               latitude 38[deg]58[min]39[sec] N,
                                                                               longitude 076[deg]20[min]10[sec]
                                                                               W.
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                                                  * * * * * * *
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                                   Coast Guard Sector Hampton Roads--COTP Zone
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                                                  * * * * * * *
42...........  July--last           Pony Penning Swim..  Chincoteague         The waters of Assateague Channel
                Wednesday and                             Volunteer Fire       from shoreline to shoreline,
                following Friday.                         Department.          bounded to the east by a line
                                                                               drawn from latitude
                                                                               37[deg]55[min]00[sec] N,
                                                                               longitude 075[deg]22[min]45[sec]
                                                                               W, to latitude
                                                                               37[deg]54[min]47[sec] N,
                                                                               longitude 075[deg]22[min]45[sec]
                                                                               W, and to the south by a line
                                                                               drawn from latitude
                                                                               37[deg]54[min]47[sec] N,
                                                                               longitude 075[deg]22[min]45[sec]
                                                                               W, to latitude
                                                                               37[deg]54[min]47[sec] N,
                                                                               longitude 075[deg]23[min]04[sec]
                                                                               W.

                                                  * * * * * * *
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    Dated: June 10, 2009.
Fred M. Rosa, Jr.,
Rear Admiral, U.S. Coast Guard, Commander, Fifth Coast Guard District.
[FR Doc. E9-15024 Filed 6-24-09; 8:45 am]

BILLING CODE 4910-15-P


[Federal Register Volume 87, Number 57 (Thursday, March 24, 2022)]
[Notices]
[Page 16725]
[FR Doc No: 2022-06231]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. TX22-3-000]

Empire II, LLC; Notice of Filing

    Take notice that on March 14, 2022, pursuant to section 211 of the
Federal Power Act,\1\ and Section 9.3.3 of the San Diego Gas & Electric
Company (SDG&E) Transmission Owner Tariff (SDG&E TO Tariff), Empire II,
LLC (Empire) filed an application requesting that the Federal Energy
Regulatory Commission (Commission) issue an order requiring SDG&E to
provide interconnection and transmission service for proposed solar
photovoltaic and battery energy storage facility under the terms and
conditions of the Transmission Control Agreement between SDG&E and the
California Independent System Operator Corporation (CAISO), the SDG&E
TO Tariff, CAISO's Fifth Replacement FERC Electric Tariff,\2\ and the
Generator Interconnection Agreement among Empire, SDG&E, and CAISO,
dated April 12, 2021, as may be in effect from time to time.
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    \1\ 16 U.S.C. 824j (2018).
    \2\ Capitalized terms that are not otherwise defined herein have
the meanings set forth in the CAISO Tariff.
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    Any person desiring 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 comment date.
Anyone filing a motion to intervene or protest must serve a copy of
that document on the Applicant. On or before the comment date, it is
not necessary to serve motions to intervene or protests on persons
other than the Applicant.
    In addition to publishing the full text of this document in the
Federal Register, the Commission provides all interested persons an
opportunity to view and/or print the contents of this document via the
internet through the Commission's Home Page (http://ferc.gov) using the
``eLibrary'' link. Enter the docket number excluding the last three
digits in the docket number field to access the document. At this time,
the Commission has suspended access to the Commission's Public
Reference Room, due to the proclamation declaring a National Emergency
concerning the Novel Coronavirus Disease (COVID-19), issued by the
President on March 13, 2020. For assistance, contact FERC at
[email protected] or call toll-free,<PHONE_NUMBER> or TYY,
(202) 502-8659.
    The Commission strongly encourages electronic filings of comments,
protests and interventions in lieu of paper using the ``eFiling'' link
at http://www.ferc.gov. Persons unable to file electronically may mail
similar pleadings to the Federal Energy Regulatory Commission, 888
First Street NE, Washington, DC 20426. Hand delivered submissions in
docketed proceedings should be delivered to Health and Human Services,
12225 Wilkins Avenue, Rockville, Maryland 20852.
    Comment Date: 5:00 p.m. Eastern Time on April 4, 2022.

    Dated: March 18, 2022.
Kimberly D. Bose,
Secretary.
[FR Doc. 2022-06231 Filed 3-23-22; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 82, Number 59 (Wednesday, March 29, 2017)]
[Notices]
[Pages 15552-15554]
[FR Doc No: 2017-06181]

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DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

[Docket No. FMCSA-2013-0124; FMCSA-2014-0103; FMCSA-2014-0106; FMCSA-
2014-0102; FMCSA-2014-0105; FMCSA-2014-0107; FMCSA-2014-1004]

Qualification of Drivers; Exemption Applications; Hearing

AGENCY: Federal Motor Carrier Safety Administration (FMCSA), DOT.

ACTION: Notice of renewal of exemptions; request for comments.

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SUMMARY: FMCSA announces its decision to renew exemptions for 31
individuals from the hearing requirement in the Federal Motor Carrier
Safety Regulations (FMCSRs) for interstate commercial motor vehicle
(CMV) drivers. The exemptions enable these hard of hearing and deaf
individuals to continue to operate CMVs in interstate commerce.

DATES: The renewed exemptions were effective on the dates stated in the
discussions below and will expire on the dates stated in the
discussions below. Comments must be received on or before April 28,
2017.

FOR FURTHER INFORMATION CONTACT: Ms. Christine A. Hydock, Chief,
Medical Programs Division,<PHONE_NUMBER><EMAIL_ADDRESS>FMCSA,
Department of Transportation, 1200 New Jersey Avenue SE., Room W64-224,
Washington, DC 20590-0001. Office hours are from 8:30 a.m. to 5 p.m.,
e.t., Monday through Friday, except Federal holidays. If you have
questions regarding viewing or submitting material to the docket,
contact Docket Services, telephone<PHONE_NUMBER>.

ADDRESSES: You may submit comments bearing the Federal Docket
Management System (FDMS) Docket No. FMCSA-2013-0124; FMCSA-2014-0103;
FMCSA-2014-0106; FMCSA-2014-0102; FMCSA-2014-0105; FMCSA-2014-0107;
FMCSA-2014-0104 using 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: West Building Ground Floor, Room W12-140,
1200 New Jersey Avenue SE., Washington, DC, between 9 a.m. and 5 p.m.
e.t., Monday through Friday, except Federal Holidays.
     Fax: 1-202-493-2251.
    Instructions: Each submission must include the Agency name and the
docket number(s) for this notice. 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
for further information.
    Docket: For access to the docket to read background documents or
comments, go to http://www.regulations.gov at any time or Room W12-140
on the ground level of the West Building, 1200 New Jersey Avenue SE.,
Washington, DC, between 9 a.m. and 5 p.m., e.t. Monday through Friday,
except Federal holidays. The FDMS is available 24 hours each day, 365
days each year. If you want acknowledgment that we received your
comments, please include a self-addressed, stamped envelope or postcard
or print the acknowledgement page that appears after submitting
comments online.
    Privacy Act: In accordance with 5 U.S.C. 553(c), DOT solicits
comments from the public to better inform its rulemaking process. DOT
posts these comments, without edit, including any personal information
the commenter provides, to http://www.regulations.gov, as described in
the system of records notice (DOT/ALL-14 FDMS), which can be reviewed
at http://www.dot.gov/privacy.

I. Background

    Under 49 U.S.C. 31136(e) and 31315, FMCSA may grant an exemption
for two years if it finds ``such exemption would likely achieve a level
of safety that is equivalent to or greater than the level that would be
achieved absent such exemption.'' The statute also allows the Agency to
renew exemptions at the end of the two-year period.
    The physical qualification standard for drivers regarding hearing
found in 49 CFR 391.41(b)(11) states that a person is physically
qualified to drive a CMV if that person:

    First perceives a forced whispered voice in the better ear at
not less than 5 feet with or without the use of a hearing aid or, if
tested by use of an audiometric device, does not have an average
hearing loss in the better ear greater than 40 decibels at 500 Hz,
1,000 Hz, and 2,000 Hz with or without a hearing aid

when the audiometric device is calibrated to American National
Standard (formerly ASA Standard) Z24.5--1951.

    49 CFR 391.41(b)(11) was adopted in 1970, with a revision in 1971
to allow drivers to be qualified under this standard while wearing a
hearing aid, 35 FR 6458, 6463 (April 22, 1970) and 36 FR 12857 (July 3,
1971).
    The 31 individuals listed in this notice have requested renewal of
their exemptions from the hearing standard in 49 CFR 391.41(b)(11), in
accordance with FMCSA procedures. Accordingly, FMCSA has evaluated
these applications for renewal on their merits and decided to extend
each exemption for a renewable two-year period.

II. Request for Comments

    Interested parties or organizations possessing information that
would otherwise show that any, or all, of these drivers are not
currently achieving the statutory level of safety should immediately
notify FMCSA. The Agency will evaluate any adverse evidence submitted
and, if safety is being compromised or if continuation of the exemption
would not be consistent with the goals and objectives of 49 U.S.C.
31136(e) and 31315, FMCSA will take immediate steps to revoke the
exemption of a driver.

III. Basis for Renewing Exemptions

    Under 49 U.S.C. 31315(b)(1), an exemption may be granted for no
longer than two years from its approval date and may be renewed upon
application. In accordance with 49 U.S.C. 31136(e) and 31315, each of
the twelve applicants has satisfied the renewal conditions for
obtaining an exemption from the hearing requirement (80 FR 57032; 80 FR
60747). In addition, for Commercial Driver's License (CDL) holders, the
Commercial Driver's License Information System (CDLIS) and the Motor
Carrier Management Information System (MCMIS) are searched for crash
and violation data. For non-CDL holders, the Agency reviews the driving
records from the State Driver's Licensing Agency (SDLA). These factors
provide an adequate basis for predicting each driver's ability to
continue to safely operate a CMV in interstate commerce.
    The 31 drivers in this notice remain in good standing with the
Agency and have not exhibited any medical issues that would compromise
their ability to safely operate a CMV during the previous two-year
exemption period. FMCSA has concluded that renewing the exemptions for
each of these applicants is likely to achieve a level of safety equal
to that existing without the exemption. Therefore, FMCSA has decided to
renew each exemption for a two-year period. In accordance with 49
U.S.C. 31136(e) and 31315, each driver has received a renewed
exemption.
    As of March 3, 2017, the following 7 individuals have satisfied the
renewal conditions for obtaining an exemption from the hearing
requirement in 49 CFR 391.41(b)(11), from driving CMVs in interstate
commerce (80 FR 60747):

Kevin Ballard (TX)
Scott Friede (NE)
Jeremiah Hoagland (CO)
Kimothy McLoed (GA)
Victor Morales (TX)
Branden Veronie (LA)
Anthony Witcher (MI)

    The drivers were included in FMCSA-2014-0106. The exemptions were
effective on March 3, 2017, and will expire on March 3, 2019.
    As of March 10, 2017, David Helgreson (WI) and Susan Helgreson (WI)
have satisfied the renewal conditions for obtaining an exemption from
the hearing requirement in 49 CFR 391.41(b)(11), from driving CMVs in
interstate commerce (80 FR 18924).
    The drivers were included in FMCSA-2014-0124. The exemptions were
effective on March 10, 2017, and will expire on March 10, 2019.
    As of March 13, 2017, the following 5 individuals have satisfied
the renewal conditions for obtaining an exemption from the hearing
requirements in 49 CFR 391.41(b)(11), from driving CMVs in interstate
commerce (80 FR 57029):

Thomas Bertling (OR)
John Huey Jr. (AZ)
Scott Putman (PA)
Christopher Warner (NY)
Paul Langois (OH)

    The drivers were included in FMCSA-2014-0107. The exemptions were
effective on March 13, 2017, and will expire on March 13, 2019.
    On March 19, 2017, Jesse Shelander (TX) has satisfied the renewal
conditions for obtaining an exemption from the hearing requirement in
49 CFR 391.41(b)(11), from driving in interstate commerce (80 FR
57032). The driver was included in FMCSA-2014-0103. The exemption was
effective on March 19, 2017, and will expire on March 19, 2019.
    As of March 29, 2017, the following 7 drivers have satisfied the
renewal conditions for obtaining an exemption from the hearing
requirement in 49 CFR 391.41(b)(11), from driving in interstate
commerce (80 FR 18924):

Richard Boggs (OH)
Conley Bowling (KY)
Kareem Douglas (OH)
Danny Fisk (CO)
Kenneth Frilando (NY)
Kenneth Harris (TX)
Victor Robinson (LA)

    The drivers were included in FMCSA-2014-0124. The exemptions were
effective on March 29, 2017, and will expire on March 29, 2019.
    As of March 29, 2017, Robert Parrish (NV) and Nathaniel Godfrey
(KY) have satisfied the renewal conditions for obtaining an exemption
from the hearing requirement in 49 CFR 391.41(b)(11), from driving in
interstate commerce (80 FR 57032). The drivers were included in FMCSA-
2014-0103. The exemptions were effective on March 29, 2017 and will
expire on March 29, 2019.
    As of March 29, 2017 Weston Arthurs (CA) and Floyd McClain (FL)
have satisfied the hearing requirements in 49 CFR 391.41(b)(11), from
driving in interstate commerce (80 FR 60741). The drivers were included
in FMCSA-2014-0106. The exemptions were effective on March 29, 2017,
and expire on March 29, 2019.
    As of March 29, 2017, Timothy Laporte (NY) has satisfied renewal
requirements for obtaining an exemption from the hearing requirement in
49 CFR 391.41(b)(11), from driving in interstate commerce (80 FR
22768). The driver was included in FMCSA-2014-0102. The exemption was
effective on March 29, 2017, and will expire March 29, 2019.
    As of March 29, 20017, Steven Levine (MN) and Bruce Walker (NY)
have satisfied the renewal requirements for obtaining an exemption from
the hearing requirement in 49 CFR 391.41(b)(11), from driving in
interstate commerce (80 FR 60735). The drivers were included in FMCSA-
2014-0105. The exemptions were effective on March 29, 2017, and expire
on March 29, 2019.
    As of March 29, 2017, Kirk Soneson (OH) has satisfied the renewal
requirements for obtaining an exemption from the hearing requirement in
49 CFR 391.41(b)(11), from driving in interstate commerce (80 FR
57029). The driver was included in FMCSA-2014-0107. The exemption was
effective on March 29, 2017, and will expire on March 29, 2019.
    As of March 29, 2017, Brandon Lango (TX) has satisfied the renewal
requirements for obtaining an exemption from the hearing requirement in
49 CFR 391.41(b)(11), from driving in interstate commerce (80 FR
60747). The driver was included in FMCSA-2014-0104. The exemption was
effective on March 29, 2017, and will expire on March 29, 2019.

IV. Conditions and Requirements

    The exemptions are extended subject to the following conditions:
(1) Each driver must report any crashes or accidents as defined in 49
CFR 390.5; and (2) report all citations and convictions for
disqualifying offenses under 49 CFR part 383 and 49 CFR 391 to FMCSA.
In addition, the driver must also have a copy of the exemption when
driving, for presentation to a duly authorized Federal, State, or local
enforcement official. The driver is prohibited from operating a
motorcoach or bus with passengers in interstate commerce. The exemption
does not exempt the individual from meeting the applicable CDL testing
requirements. Each exemption will be valid for two years unless
rescinded earlier by FMCSA. The exemption will be rescinded if: (1) The
person fails to comply with the terms and conditions of the exemption;
(2) the exemption has resulted in a lower level of safety than was
maintained before it was granted; or (3) continuation of the exemption
would not be consistent with the goals and objectives of 49 U.S.C.
31136(e) and 31315.

IV. Conclusion

    Based upon its evaluation of the 32 exemption applications, FMCSA
renews the exemptions of the aforementioned drivers from the hearing
requirement in 49 CFR 391.41(b)(11). In accordance with 49 U.S.C.
31136(e) and 31315, each exemption will be valid for two years unless
revoked earlier by FMCSA.

    Issued on: March 22, 2017.
Larry W. Minor,
Associate Administrator for Policy.
[FR Doc. 2017-06181 Filed 3-28-17; 8:45 am]
 BILLING CODE 4910-EX-P


[Federal Register Volume 79, Number 216 (Friday, November 7, 2014)]
[Rules and Regulations]
[Pages 66294-66301]
[FR Doc No: 2014-26430]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2014-0297; FRL-9918-24]

Deltamethrin; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

SUMMARY: This regulation establishes tolerances for residues of
deltamethrin in or on finfish. Center for Regulatory Services, Inc., on
behalf of PHARMAQ AS, requested these tolerances under the Federal
Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective November 7, 2014. Objections and
requests for hearings must be received on or before January 6, 2015,
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-2014-0297, is 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), West William Jefferson Clinton 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: Susan Lewis, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; main 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 EPA's
tolerance regulations at 40 CFR part 180 through

the Government Printing Office's e-CFR site at http://www.ecfr.gov/cgi-bin/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-2014-0297 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
January 6, 2015. 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-2014-0297, 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. Summary of Petitioned-For Tolerance

    In the Federal Register of May 23, 2014 (79 FR 29729) (FRL-9910-
29), EPA issued a document pursuant to FFDCA section 408(d)(3), 21
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP
3E8178) by the Center for Regulatory Services, Inc, 5200 Wolf Run
Shoals Rd., Woodbridge, VA 22192-5755, on behalf of PHARMAQ AS, P.O.
Box 267, Sk[oslash]yen, N-0213 Oslo, Norway. The petition requested
that 40 CFR 180.435 be amended by establishing tolerances for residues
of the insecticide deltamethrin, (1R, 3R)-3(2,2-dibromovinyl)-2,2-
dimethylcyclopropane-carboxylic acid (S)-alpha-cyano-3-phenoxybenzyl
ester and its major metabolites: Trans-deltamethrin, (s)-alpha-cyano-3-
phenoxybenzyl-(1R, 3S)-3-(2,2-dibromovinyl)-2,2-
dimethylcyclopropanecarboxylate, and alpha-R-deltamethrin, (R)-
alphacyano-3-phenoxybenzyl-(1R, 3R)-3-(2,2-dibromovinyl)-2,2-
dimethylcyclopropanecarboxylate, in or on finfish at 0.01 parts per
million (ppm). That document referenced a summary of the petition
prepared by PHARMAQ AS, the registrant, which is available in the
docket, http://www.regulations.gov. Comments were received on the
notice of filing. EPA's response to these comments is discussed in Unit
IV.C.
    Based upon review of the data supporting the petition, EPA has
revised the petition by correcting the commodity definition. The Agency
also revised the tolerance expression for deltamethrin. The reasons for
these changes are explained in Unit IV.D.

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 FFDCA section 408(b)(2)(D), and the factors
specified in FFDCA section 408(b)(2)(D), 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 deltamethrin including exposure
resulting from the tolerances established by this action. EPA's
assessment of exposures and risks associated with deltamethrin 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.
    Deltamethrin, a Type II pyrethroid, targets the nervous system by
disrupting the voltage-gated sodium channels, resulting in
neurotoxicity. Neurotoxicity was observed throughout the toxicity
database, and effects were seen across species, sexes, exposure
duration, and routes of administration. Clinical signs characteristic
of Type II pyrethroids, such as increased salivation, altered mobility/
gait, and tremors were the most common effects observed. Increased
sensitivity to external stimuli, abnormal vocalization, and decreased
fore- and hind-limb grip strength were also commonly observed in the
database.
    Deltamethrin is rapidly absorbed following an oral dose, and
effects are typically observed within 2 to 5 hours after dosing. For
pyrethroids, as a class, the combination of rapid absorption,
metabolism, and elimination precludes accumulation and increased
potency following repeated dosing. This is also true of deltamethrin.
No observed adverse effect levels (NOAELs) for the acute and chronic
studies are similar, and the acute endpoint is protective of the
endpoints from repeat dosing studies. The Wolansky et al. acute oral
study (2006), provides the most robust data set for extrapolating risk
from exposure to deltamethrin. The dose used for risk assessment was
determined using a benchmark dose (BMD) analysis using one standard
deviation from the control group as the benchmark response (BMR). The
study endpoint and dose were used for all exposure scenarios.
    A dermal risk assessment was not conducted based on the lack of
effects in a 21-day dermal study and low potential for dermal
absorption for deltamethrin. These findings are consistent with the
toxicology profile of many pyrethroids.

    Deltamethrin did not have any adverse effects on fetuses or
offspring in the prenatal developmental studies in rats and rabbits.
However, potential qualitative susceptibility was observed at high
doses in the developmental neurotoxicity study (DNT) and the 2-
generation reproduction study. Symptoms included vocalization,
decreased pre- and post-weaning body weight in pups of both sexes,
decreased body weight and body weight gain in maternal animals,
hyperactivity, and excessive salivation. The increased qualitative
susceptibility in the DNT and 2-generation reproduction study was
observed at doses 10- to 20-fold higher (near lethal doses) than the
current points of departure (PODs) selected for risk assessment. At
doses near the POD, no effects on parental animals or offspring were
observed in either the DNT or 2-generation reproductive studies.
Therefore, the current PODs are protective of the observed sensitivity.
    There was no evidence of immunotoxicity after deltamethrin exposure
in the toxicology database or in an immunotoxicity study in rats.
Deltamethrin is classified as ``not likely to be carcinogenic to
humans.'' There was no evidence of carcinogenicity in the combined
chronic/carcinogenicity study in rats or the carcinogenicity study in
mice. In a battery of mutagenicity studies there was no evidence of a
mutagenic effect.
    The database shows that deltamethrin has moderate to minimal acute
toxicity via the oral route, moderate acute toxicity via the inhalation
route, and minimal acute toxicity via the dermal route of exposure.
Deltamethrin is minimally irritating to the eyes, non-irritating to the
skin, and is not a skin sensitizer.
    The Agency is making best use of the extensive scientific knowledge
about the mode of action/adverse outcome pathway (MOA/AOP) on
pyrethroids in the risk assessments for this class of pesticides. A
significant portion of the scientific literature on pyrethroids
utilizes deltamethrin as the test chemical. In the on-going work by the
Council for the Advancement of Pyrethroid Human Risk Assessment
(CAPHRA), deltamethrin is one of two sentinel pyrethroids being used to
develop the initial, extensive database of in vitro and in vivo
toxicology studies and highly refined physiologically based
pharmacokinetic (PBPK) models. Pharmacokinetics (PK) can be defined as
what the body does to the chemical. The underlying PK of pyrethroids is
an important determination of their toxicity because the concentration
of pyrethroid at the sodium channel relates to the extent of toxicity;
greater pyrethroid concentration translates as increased neurotoxicity.
Age-dependent PK differences have been identified for several
pyrethroids (i.e., there are differences in the ability of adults and
juveniles to metabolize pyrethroids). The enzymes that metabolize and
detoxify pyrethroids are present in rats and humans at birth, and as a
result, both juveniles and adults are able to tolerate low doses of
pyrethroids when the internal dose, or the amount of pyrethroid at the
sodium channel, is low. However, the activity of these enzymes
increases with age, conveying in adults a greater capacity to detoxify
pyrethroids compared to juveniles and the PK contribution to the Food
Quality Protection Act Safety Factor (FQPA SF) will be 1x for adults
and children >6 years old, and 3x for children <6 years old.
    Pharmacodynamics (PD) can be defined as the changes that chemicals
cause to the body, in this case, how pyrethroids interact with the
sodium channels. In contrast to the age-related PK differences
identified for pyrethroids, PD contributions to pyrethroid toxicity are
not age-dependent. The occurrence and ontogeny of voltage-gated sodium
channels in humans are not well characterized compared to those in the
rat. The available data indicate that the rat is a highly sensitive
model and extrapolations from the rat would be protective of human
health. Based on the comparable function and distribution of sodium
channels between the species, the rat is an appropriate surrogate for
the evaluation of human PD. Based on the body of data, the Agency
concludes that juvenile rats are not more sensitive than adults with
respect to pyrethroid PD, and the PD contribution to the FQPA SF will
be 1x.
    The Wolansky et al. acute oral study (2006), in which decreased
motor activity was observed, provides the most robust data set for
extrapolating risk from exposure to deltamethrin. The dose used for
risk assessment was determined using a BMD analysis using one standard
deviation from the control group as the BMR as suggested for continuous
endpoints in the Agency's BMD guidance (EPA, 2012). The Wolansky et al.
acute study, endpoint, and dose were used for all dietary (acute), non-
occupational (incidental oral and inhalation), and occupational
exposure (inhalation) scenarios because it was the most robust data set
for extrapolating risk from deltamethrin, and there is a lack of
increased hazard from repeated/chronic exposure to deltamethrin.
    Specific information on the studies received and the nature of the
adverse effects caused by deltamethrin as well as the no-observed-
adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-
level (LOAEL) from the toxicity studies can be found at http://www.regulations.gov in the document entitled ``Deltamethrin. Human
Health Risk Assessment for the Proposed Use of Deltamethrin without
U.S. Registration on Finfish'' at p. 46 in docket ID number EPA-HQ-OPP-
2014-0297.

B. Toxicological Points of Departure/Levels of Concern

    Once a pesticide's toxicological profile is determined, EPA
identifies toxicological PODs and levels of concern to use in
evaluating the risk posed by human exposure to the pesticide. For
hazards that have a threshold below which there is no appreciable risk,
the toxicological POD is used as the basis for derivation of reference
values for risk assessment. PODs are developed based on a careful
analysis of the doses in each toxicological study to determine the dose
at which no adverse effects are observed (the NOAEL) and the lowest
dose at which adverse effects of concern are identified (the LOAEL).
Uncertainty/safety factors are used in conjunction with the POD to
calculate a safe exposure level--generally referred to as a population-
adjusted dose (PAD) or a reference dose (RfD)--and a safe margin of
exposure (MOE). 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 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 deltamethrin used for
human risk assessment is shown in Table 1 of this unit.

 Table 1--Summary of Toxicological Doses and Endpoints for Deltamethrin for Use in Human Health Risk Assessment
----------------------------------------------------------------------------------------------------------------
                                    Point of departure
        Exposure/scenario            and uncertainty/     RfD, PAD, LOC for     Study and toxicological effects
                                      safety factors       risk assessment
----------------------------------------------------------------------------------------------------------------
Acute dietary (>=6 years old)....  POD = Wolansky......  Acute RfD = 0.015    Wolansky BMDL1SD = 2.48 mg/kg
                                   BMDL1SD = 1.49 mg/kg   mg/kg                based on decreased motor
                                   UFA = 10 x..........  aPAD = 0.015 mg/kg/   activity.
                                   UFH = 10 x..........   day.
                                   FQPA SF = 1 x.......
----------------------------------------------------------------------------------------------------------------
Acute dietary (<6 years old).....  POD = Wolansky......  Acute RfD = 0.015    Wolansky BMDL1SD = 2.48 mg/kg
                                   BMDL1SD = 1.49 mg/kg   mg/kg                based on decreased motor
                                   UFA = 10 x..........  aPAD = 0.005 mg/kg/   activity.
                                   UFH = 10 x..........   day.
                                   FQPA SF = 3 x.......
----------------------------------------------------------------------------------------------------------------
Chronic Dietary..................  A chronic dietary risk assessment was not conducted because there is no
                                    apparent increase in hazard from repeated/chronic exposures to deltamethrin.
----------------------------------------------------------------------------------------------------------------
Incidental oral short-term (1 to   POD = Wolansky......  LOC for MOE = 300..  Wolansky BMDL1SD = 2.48 mg/kg
 30 days).                         BMDL1SD = 1.49 mg/kg                        based on decreased motor
                                   UFA = 10 x..........                        activity.
                                   UFH = 10 x..........
                                   FQPA SF = 3 x.......
----------------------------------------------------------------------------------------------------------------
* Inhalation short-term (1 to 30   POD = Wolansky......  LOC for MOE = 100..  Wolansky BMDL1SD = 2.48 mg/kg
 days; >=6 years old).             BMDL1SD = 1.49 mg/kg                        based on decreased motor
                                   UFA = 10 x..........                        activity.
                                   UFH = 10 x..........
                                   FQPA SF = 1 x.......
----------------------------------------------------------------------------------------------------------------
* Inhalation short-term (1 to 30   POD = Wolansky......  LOC for MOE = 300..  Wolansky BMDL1SD = 2.48 mg/kg
 days; <6 years old).              BMDL1SD = 1.49 mg/kg                        based on decreased motor
                                   UFA = 10 x..........                        activity.
                                   UFH = 10 x..........
                                   FQPA SF = 3 x.......
----------------------------------------------------------------------------------------------------------------
Cancer (oral, dermal, inhalation)  Classification: ``Not likely to be Carcinogenic to Humans'' based on the
                                    absence of treatment related tumors in two adequate rodent carcinogenicity
                                    studies.
----------------------------------------------------------------------------------------------------------------
BMDL1SD = the 95% lower confidence limit of the central estimate of the dose that results in decreased motor
  activity compared to control animals based upon one standard deviation using Benchmark Dose Analysis. FQPA SF
  = Food Quality Protection Act Safety Factor. LOC = level of concern. Mg/kg/day = milligram/kilogram/day. MOE =
  margin of exposure. PAD = population adjusted dose (a = acute, c = chronic). POD = Point of departure: A data
  point or an estimated point that is derived from observed dose-response data and used to mark the beginning of
  extrapolation to determine risk associated with lower environmentally relevant human exposures. RfD =
  reference dose. UF = uncertainty factor. UFA = extrapolation from animal to human (interspecies). UFH =
  potential variation in sensitivity among members of the human population (intraspecies).
* Inhalation toxicity is assumed to be equivalent to toxicity via the oral route.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to deltamethrin, EPA considered exposure under the petitioned-
for tolerances as well as all existing deltamethrin tolerances in 40
CFR 180.435. EPA assessed dietary exposures from deltamethrin 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. Such effects were identified
for deltamethrin. In estimating acute dietary exposure, EPA used food
consumption information from the United States Department of
Agriculture (USDA) 2003-2008 National Health and Nutrition Examination
Survey, What We Eat in America (NHANES/WWEIA). As to residue levels in
food, EPA used tolerance level residues for most commodities and
Pesticide Data Program (PDP) monitoring data for apples, apple juice,
apple sauce, cantaloupe, carrots, cereal grains, cucumbers, milk,
pears, soybeans, tomatoes, and watermelons. Maximum percent crop
treated (PCT) estimates were used for some commodities. Default
processing factors were used for some processed commodities and
empirical factors were used for others.
    ii. Chronic exposure. In conducting the chronic dietary exposure
assessment EPA used the food consumption data from the USDA 2003-2008
NHANES/WWEIA. As to residue levels in food, since deltamethrin is
registered for use in food handling establishments (FHEs), residue
values were entered for all commodities in the Dietary Exposure
Evaluation Model software-Food Commodity Intake Database (DEEM-

FCID). Tolerance level residues were used for most commodities. For
cereal grain commodities, average monitoring data values were used. For
milk, PDP monitoring data were used. For the commodities for which the
only established tolerance is the FHE tolerance, a residue value of
0.025 ppm (\1/2\ the FHE tolerance) was used. The FHE tolerance is
based on the Limit of Quantitation (LOQ), and \1/2\ the tolerance was
used as a refinement in the dietary assessment. For commodities with
tolerances for agricultural uses, average PCT estimates were generally
used. For the commodities for which \1/2\ the FHE tolerance was used,
the assumption was made that there was a 4.65% chance that a food item
consumed by a person contained deltamethrin residues as a result of
treatment at some point in an FHE.
    The chronic assessment was conducted solely for the purpose of
obtaining estimates of background levels of dietary exposure for
estimating aggregate risk.
    iii. Cancer. Based on the data summarized in Unit III.A., EPA has
concluded that deltamethrin does not pose a cancer risk to humans.
Therefore, a dietary exposure assessment for the purpose of assessing
cancer risk is unnecessary.
    iv. Anticipated residue and 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 estimated the PCT for existing uses as follows. For
acute dietary: 2.5% for apples, cantaloupes, carrots, soybeans,
tomatoes, and watermelons; 5% for cucumbers and pears. For chronic
dietary: 1% for apples, cantaloupes, carrots, cotton, potatoes (some
food forms), pumpkins, radishes, squash, tomatoes, turnips, and
watermelon; 2.5% for cucumbers, leeks, onions, pears, and sunflowers;
4.65% for the commodities for which \1/2\ the FHE tolerance was used;
5% for canola and peppers; 40% for globe artichokes; and 100% for all
other commodities for which direct treatment is allowed.
    In the chronic assessment, for the commodities for which \1/2\ the
FHE tolerance was used, the assumption was made that there was a 4.65%
chance that a food item consumed by a person contained deltamethrin
residues as a result of treatment at some point in an FHE.
    In most cases, EPA uses available data from USDA/National
Agricultural Statistics Service (NASS), proprietary market surveys, and
the National Pesticide Use Database for the chemical/crop combination
for the most recent 6-7 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 deltamethrin 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 deltamethrin in drinking water. These simulation models
take into account data on the physical, chemical, and fate/transport
characteristics of deltamethrin. 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 Screening Concentration in Ground Water (SCI-GROW)
models, the estimated drinking water concentrations (EDWCs) of
deltamethrin for acute and chronic exposures are estimated to be 0.200
parts per billion (ppb) for both surface water and ground water.
Modeled estimates of drinking water concentrations were directly
entered into the dietary exposure model.
    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).
    Deltamethrin is currently registered for the following uses that
could result in residential exposures: Residential outdoor and indoor
sites, turf, paint additives, and pet products. EPA assessed potential
exposures for residential handlers using several application methods
including handwand and backpack sprayers to treat lawns, turf, and
trees; and using shaker cans and aerosol sprays for trees and indoor
crack and crevice applications. A quantitative dermal assessment for
residential handlers was not conducted since no systemic toxicity
associated with dermal exposure to deltamethrin was observed.

MOEs were calculated for the inhalation route of exposure only. Adult
post-application exposures were not quantitatively assessed since no
dermal hazard was identified for deltamethrin and inhalation exposures
are typically negligible in outdoor settings. Furthermore, the
inhalation exposure assessment performed for residential handlers is
representative of worse case inhalation exposures and is considered
protective for post-application inhalation scenarios.
    EPA assessed post-application incidental oral exposures to children
for representative indoor/outdoor and pet incidental oral scenarios
including hand-to-mouth, object-to-mouth, soil ingestion, and episodic
granule ingestion scenarios. Further information regarding EPA standard
assumptions and generic inputs for residential exposures may be found
at http://www.epa.gov/pesticides/trac/science/trac6a05.pdf.
    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.''
    The Agency has determined that the pyrethroids and pyrethrins share
a common mechanism of toxicity: The ability to interact with voltage-
gated sodium channels ultimately leading to neurotoxicity. The
cumulative risk assessment (CRA) for the pyrethroids/pyrethrins
(published in the Federal Register of November 9, 2011 (76 FR 69726)
(FRL-8888-9), and available at http://www.regulations.gov; EPA-HQ-OPP-
2011-0746) did not identify cumulative risks of concern, allowing the
Agency to consider new uses for pyrethroids. Deltamethrin was included
in the pyrethroid/pyrethrin CRA.
    Dietary exposures make a minor contribution to the total pyrethroid
exposure. The dietary exposure assessment performed in support of the
pyrethroid CRA was much more highly refined than that performed for
deltamethrin alone. Additionally, the PODs selected for deltamethrin
are specific to deltamethrin, whereas the PODs selected for the
cumulative assessment were based on common mechanism of action data
that are appropriate for all 20 pyrethroids included in the CRA.
Dietary exposure to deltamethrin residues resulting from the proposed
import tolerance on finfish will contribute very little to the dietary
exposure to deltamethrin alone and will have an insignificant impact on
the cumulative risk assessment. No dietary, residential, or aggregate
risk estimates of concern have been identified in the single chemical
assessment.
    In the cumulative assessment, residential exposure was the greatest
contributor to the total exposure. In order to determine if the
registered deltamethrin indoor and turf uses will significantly
contribute to, or change the overall findings in the pyrethroid CRA,
the Agency performed a quantitative exposure and risk assessment. This
assessment used the deltamethrin relative potency factor (RPF) as well
as the same exposure algorithms and inputs that were used in the 2011
pyrethroid CRA. In all cases, the estimated deltamethrin MOEs using the
RPF method were higher (i.e., less of a risk concern) than those used
in the 2011 pyrethroid CRA. Thus, the Agency continues to support the
previous assessment, and concludes that the registered deltamethrin
uses will not significantly contribute to the overall findings in the
2011 pyrethroid CRA, and the proposed import tolerance for finfish will
have no impact on the residential component of the cumulative risk
estimates.
    For information regarding EPA's efforts to evaluate the risk of
exposure to this class of chemicals, refer to: http://www.epa.gov/oppsrrd1/reevaluation/pyrethroids-pyrethrins.html.

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 SF. In
applying this provision, EPA either retains the default value of 10X,
or uses a different additional SF when reliable data available to EPA
support the choice of a different factor.
    2. Prenatal and postnatal sensitivity. There were no indications of
fetal toxicity in any of the guideline studies. Evidence of increased
juvenile qualitative sensitivity was observed in the DNT and 2-
generation reproduction studies at doses that were considered to be
relatively high (i.e., near lethal doses). However, at doses near the
POD, no effects on parental animals or offspring were observed in
either the DNT or 2-generation reproduction study and, therefore, there
is no susceptibility at these doses.
    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 3x for infants and children <6 years old; and
to 1x for children >6 years old, women of child bearing age and all
adult populations. That decision is based on the following findings:
    i. The database of experimental toxicology studies available for
deltamethrin is largely complete including developmental toxicity
studies in rats and rabbits, a reproduction study in rats, and acute
neurotoxicity (ACN), subchronic neurotoxicity (SCN), and DNT studies.
The database provides a robust characterization profile for children 6
years old and older, as well as for adults. In addition to the standard
guideline studies, numerous studies from the scientific literature that
describe the PD and PK profile of the pyrethroids in general have been
considered in this assessment. Many of these studies were conducted
with deltamethrin. A 28- or 90-day inhalation study is not available,
but the Agency determined the study is not required for deltamethrin.
    ii. As with other pyrethroids, deltamethrin causes neurotoxicity
from interaction with sodium channels leading to clinical signs of
neurotoxicity. These effects are well characterized and adequately
assessed by the body of data available to the Agency.
    iii. There were no indications of fetal toxicity in any of the
guideline studies in the database, including developmental studies in
the rat and rabbit, a developmental neurotoxicity study in rats, and a
2-generation reproduction study in rats. There was evidence of
increased juvenile qualitative susceptibility at high doses observed in
both the DNT and 2-generation reproduction studies. These observations
are consistent with the findings of juvenile sensitivity in the
literature for deltamethrin. However, the observations of increased
sensitivity were at doses that were considered to be relatively high
(i.e., near lethal doses), whereas at doses near the point of
departure, no effects on parental animals or offspring were observed in
either the DNT or 2-generation reproduction study and, therefore, there
is no susceptibility at these doses. The Agency has retained a 3x
uncertainty factor to protect for exposures of

children <6 years of age based on increased quantitative susceptibility
seen in studies on pyrethroid PK (primarily conducted with
deltamethrin) and the increased quantitative juvenile susceptibility
observed in high dose guideline and literature studies with
deltamethrin and other pyrethroids. The Agency has no residual
uncertainties regarding age-related sensitivity for women of child
bearing age as well as for all adult populations and children >=6 years
of age, based on the absence of prenatal sensitivity observed in 76
guideline studies for 24 pyrethroids and the scientific literature.
Additionally, no evidence of increased quantitative or qualitative
susceptibility was seen in the pyrethroid scientific literature related
to PD.
    iv. There are no residual uncertainties with regard to dietary
exposure. The dietary exposure assessments are based on high-end
residue levels for most commodities, and that account for parent and
metabolites of concern, processing factors, and percent crop treated
assumptions. Furthermore, conservative, upper-bound assumptions were
used to determine exposure through drinking water and residential
sources, such that these exposures have not been underestimated.

E. Aggregate Risks and Determination of Safety

    EPA determines whether acute and chronic dietary pesticide
exposures are safe by comparing aggregate exposure estimates to the
acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA
calculates the lifetime probability of acquiring cancer 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 appropriate PODs to ensure that an
adequate MOE exists.
    1. Acute risk. Using the exposure assumptions discussed in this
unit for acute exposure, the acute dietary exposure from food and water
to deltamethrin will occupy 80% of the aPAD for children 3-5 years old,
the population group receiving the greatest exposure.
    2. Chronic risk. A chronic dietary risk assessment was not
conducted because there is no apparent increase in hazard from
repeated/chronic exposures to deltamethrin. Therefore, the acute
endpoint is protective of the endpoints from repeat dosing studies. A
chronic dietary exposure assessment was performed in order to generate
background exposure estimates to aggregate with residential exposure
estimates for the short-term aggregate risk assessment.
    3. Short-term risk. Short-term aggregate exposure takes into
account short-term residential exposure plus chronic exposure to food
and water (considered to be a background exposure level). Deltamethrin
is currently registered for uses that could result in short-term
residential exposure, and the Agency has determined that it is
appropriate to aggregate chronic exposure through food and water with
short-term residential exposures to deltamethrin.
    Using the exposure assumptions described in this unit for short-
term exposures, EPA has concluded the combined short-term food, water,
and residential exposures result in aggregate MOEs of 2,500 for the
general U.S. population and of 530 for children 1-2 years old, the
population group receiving the greatest exposure. Because EPA's level
of concern for deltamethrin is a MOE of 300 or below, these MOEs are
not of concern.
    4. Intermediate-term risk. Because no intermediate-term adverse
effect was identified, deltamethrin is not expected to pose an
intermediate-term risk.
    5. Aggregate cancer risk for U.S. population. Based on the lack of
evidence of carcinogenicity in two adequate rodent carcinogenicity
studies, deltamethrin is not expected to pose a cancer risk to humans.
    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 deltamethrin residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology, utilizing gas chromatography with
electron capture detection (GC/ECD), is available for enforcing
tolerances for residues of deltamethrin in plant commodities, as
described in Pesticide Analytical Manual (PAM) Volume II, Section
180.422. Another GC/ECD method (Method HRAV-22) is available for
enforcing tolerances in livestock commodities. Adequate confirmatory
method validation data have been submitted for these methods, along
with adequate independent laboratory validation (ILV) trials.
    Multi-residue methods data for cis-deltamethrin and trans-
deltamethrin were previously sent to the Food and Drug Administration
(FDA). Cis-deltamethrin is completely recovered through Methods 302 and
303, and partially recovered through Method 304. Trans-Deltamethrin is
partially recovered through Method 303, but not recovered through
Method 304.

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 Nations
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 deltamethrin in finfish.

C. Response to Comments

    One comment was received from the general public urging the Agency
to tighten regulations for pesticides tolerances and uses. The
commenter particularly addressed carcinogenic chemicals and their
effects on children's health.
    The toxicological database for deltamethrin shows that the chemical
does not pose a cancer risk to humans. Deltamethrin is classified as
``Not likely to be carcinogenic to humans'' based on the absence of
treatment related tumors in adequate rodent studies. Deltamethrin is a
Type II pyrethroid, and as with other pyrethroids, deltamethrin causes
neurotoxicity. These effects are well characterized and adequately
assessed by the body of data available to the Agency. The Agency is
confident that it has chosen endpoints, PODs, and uncertainty factors
that are protective for all populations, including infants and
children, and that have a strong scientific foundation. In addition,
there are ongoing efforts to develop data to gain more information
concerning the potential sensitivity of infants and young children to
pyrethroids as a class. EPA has addressed the variability of
sensitivities of the population to deltamethrin, including infants and
children in Unit III.D.

D. Revisions to Petitioned-For Tolerances

    Pharmaq AS requested the establishment of a permanent tolerance,
for residues of the insecticide deltamethrin in all imported
commercially farmed finfish at 0.01 ppm. Since there is no commodity
definition covering all finfish, the Agency is establishing tolerances
of 0.01 ppm in ``fish--freshwater finfish,'' ``fish--freshwater
finfish, farm raised,'' ``fish--saltwater finfish, other,'' and
``fish--saltwater finfish, tuna.''
    The Agency is revising the tolerance expression to clarify that:
    1. As provided in FFDCA section 408(a)(3), the tolerance covers
metabolites and degradates of deltamethrin not specifically mentioned.
    2. Compliance with the specified tolerance levels is to be
determined by measuring only the specific compounds mentioned in the
tolerance expression.

V. Conclusion

    Therefore, tolerances are established for residues of deltamethrin,
including its metabolites and degradates in or on fish--freshwater
finfish; fish--freshwater finfish, farm raised; fish--saltwater
finfish, other; and fish--saltwater finfish, tuna at 0.01 ppm.

VI. Statutory and Executive Order Reviews

    This final rule establishes tolerances 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).

VII. 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: October 29, 2014.
Susan Lewis,
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.  180.435:
0
a. Revise the introductory text of paragraph (a)(1).
0
b. Add alphabetically to the table in paragraph (a)(1) the following
commodities.
    The amendments read as follows:

Sec.  180.435  Deltamethrin; tolerances for residues.

    (a) General. (1) Tolerances are established for residues of
deltamethrin, including its metabolites and degradates, in or on the
commodities listed in the following table. Compliance with the
tolerance levels specified is to be determined by measuring only
deltamethrin, (1R,3R)-3-(2,2-dibromovinyl)-2,2-
dimethylcyclopropanecarboxylic acid (S)-alpha-cyano-3-phenoxybenzyl
ester, and its major metabolites, trans-deltamethrin, (S)-alpha-cyano-
m-phenoxybenzyl(1R,3S)-3-(2,2-dibromovinyl)-2,2-
dimethylcyclopropanecarboxylate, and alpha-R-deltamethrin, (R)-alpha-
cyano-m-phenoxybenzyl-(1R,3R)-3-(2,2-dibromovinyl)-2,2-
dimethylcyclopropanecarboxylate, in or on the commodity.

------------------------------------------------------------------------
                                                             Parts per
                        Commodity                             million
------------------------------------------------------------------------

                                * * * * *
Fish--freshwater finfish................................            0.01
Fish--freshwater finfish, farm raised...................            0.01
Fish--saltwater finfish, other..........................            0.01
Fish--saltwater finfish, tuna...........................            0.01

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

* * * * *
[FR Doc. 2014-26430 Filed 11-6-14; 8:45 am]
BILLING CODE 6560-50-P