[Federal Register Volume 83, Number 63 (Monday, April 2, 2018)]
[Proposed Rules]
[Pages 13885-13888]
[FR Doc No: 2018-06590]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2018-0168; Product Identifier 2017-NM-135-AD]
RIN 2120-AA64

Airworthiness Directives; Airbus Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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SUMMARY: We propose to adopt a new airworthiness directive (AD) for
certain Airbus Model A318, A319, and A320 series airplanes, and Model
A321-111, -112, -131, -211, -212, -213, -231, -232, -251N, -253N, and -
271N airplanes. This proposed AD was prompted by a revision of an
airworthiness limitations document that specifies more restrictive
maintenance requirements and airworthiness limitations. This proposed
AD would require revising the maintenance or inspection program, as
applicable, to

incorporate the specified maintenance requirements and airworthiness
limitations. We are proposing this AD to address the unsafe condition
on these products.

DATES: We must receive comments on this proposed AD by May 17, 2018.

ADDRESSES: You may send comments, using the procedures found in 14 CFR
11.43 and 11.45, by any of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov. Follow the instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE, Washington, DC 20590.
     Hand Delivery: Deliver to Mail address above between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays.
    For service information identified in this NPRM, contact Airbus,
Airworthiness Office--EIAS, 1 Rond Point Maurice Bellonte, 31707
Blagnac Cedex, France; telephone +33 5 61 93 36 96; fax +33 5 61 93 44
51; email [email protected]; internet http://www.airbus.com. You may view this service information at the FAA,
Transport Standards Branch, 2200 South 216th St., Des Moines, WA. For
information on the availability of this material at the FAA, call 206-
231-3195.

Examining the AD Docket

    You may examine the AD docket on the internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2018-
0168; or in person at the Docket Management Facility between 9 a.m. and
5 p.m., Monday through Friday, except Federal holidays. The AD docket
contains this NPRM, the regulatory evaluation, any comments received,
and other information. The street address for the Docket Operations
office (telephone<PHONE_NUMBER>) is in the ADDRESSES section. Comments
will be available in the AD docket shortly after receipt.

FOR FURTHER INFORMATION CONTACT: Sanjay Ralhan, Aerospace Engineer,
International Section, Transport Standards Branch, FAA, 2200 South
216th St., Des Moines, WA 98198; telephone and fax<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Comments Invited

    We invite you to send any written relevant data, views, or
arguments about this proposed AD. Send your comments to an address
listed under the ADDRESSES section. Include ``Docket No. FAA-2018-0168;
Product Identifier 2017-NM-135-AD'' at the beginning of your comments.
We specifically invite comments on the overall regulatory, economic,
environmental, and energy aspects of this NPRM. We will consider all
comments received by the closing date and may amend this NPRM based on
those comments.
    We will post all comments we receive, without change, to http://www.regulations.gov, including any personal information you provide. We
will also post a report summarizing each substantive verbal contact we
receive about this NPRM.

Discussion

    The European Aviation Safety Agency (EASA), which is the Technical
Agent for the Member States of the European Union, has issued EASA
Airworthiness Directive 2017-0170, dated September 7, 2017 (referred to
after this as the Mandatory Continuing Airworthiness Information, or
``the MCAI''), to correct an unsafe condition for all Airbus Model
A318, A319, and A320 series airplanes, and Model A321-111, -112, -131,
-211, -212, -213, -231, -232, -251N, -253N, and -271N airplanes. The
MCAI states:

    The System Equipment Maintenance Requirements (SEMR) for Airbus
A320 family aeroplanes, which are approved by EASA, are currently
defined and published in the Airbus A318/A319/A320/A321
Airworthiness Limitations Section (ALS) Part 4 document. These
instructions have been identified as mandatory for continued
airworthiness.
    Failure to accomplish these instructions could result in an
unsafe condition.
    Previously, EASA issued AD 2016-0093 [which corresponds to FAA
AD 2017-19-24, Amendment 39-19054 (82 FR 44900, September 27, 2017)
(``AD 2017-19-24'')] to require accomplishment of all maintenance
tasks as described in ALS Part 4 at Revision 03. ALS Part 4 Revision
04 was not mandated because no significant changes were introduced
with this Revision. The new ALS Part 4 Revision 05 (hereafter
referred to as `the ALS' in this [EASA] AD) includes new and/or more
restrictive requirements and extends the applicability to model
A320-251N, A320-271N, A321-251N, A321-253N and A321-271N aeroplanes.
    For the reason described above, this [EASA] AD retains the
requirements of EASA AD 2016-0093, which is superseded, and requires
accomplishment of all tasks as described in the ALS.

    You may examine the MCAI in the AD docket on the internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2018-
0168.

Relationship of Proposed AD to AD 2017-19-24

    This NPRM would not supersede AD 2017-19-24. Rather, we have
determined that a stand-alone AD would be more appropriate to address
the changes in the MCAI. This NPRM would require revising the
maintenance or inspection program to incorporate the new maintenance
requirements and airworthiness limitations. Accomplishment of the
proposed actions would then terminate all of the requirements of AD
2017-19-24.

Related Service Information Under 1 CFR Part 51

    Airbus has issued Airbus A318/A319/A320/A321 Airworthiness
Limitations Section (ALS) Part 4, ``System Equipment Maintenance
Requirements (SEMR),'' Revision 05, dated April 6, 2017. This service
information describes preventive maintenance requirements and includes
updated inspections and intervals to be incorporated into the
maintenance or inspection program. This service information is
reasonably available because the interested parties have access to it
through their normal course of business or by the means identified in
the ADDRESSES section.

FAA's Determination and Requirements of This Proposed AD

    This product has been approved by the aviation authority of another
country, and is approved for operation in the United States. Pursuant
to our bilateral agreement with the State of Design Authority, we have
been notified of the unsafe condition described in the MCAI and service
information referenced above. We are proposing this AD because we
evaluated all pertinent information and determined an unsafe condition
exists and is likely to exist or develop on other products of these
same type designs.
    This proposed AD would require revisions to certain operator
maintenance documents to include new actions (e.g., inspections).
Compliance with these actions is required by 14 CFR 91.403(c). For
airplanes that have been previously modified, altered, or repaired in
the areas addressed by this proposed AD, the operator may not be able
to accomplish the actions described in the revisions. In this
situation, to comply with 14 CFR 91.403(c), the operator must request
approval for an alternative method of compliance according to paragraph
(j)(1) of this proposed AD. The request should include a description of
changes to the required actions that will ensure the continued
operational safety of the airplane.

Differences Between This Proposed AD and the MCAI or Service
Information

    The MCAI specifies that if there are findings from the ALS
inspection tasks, corrective actions must be accomplished in accordance
with Airbus maintenance documentation. However, this proposed AD does
not include that requirement. Operators of U.S.-registered airplanes
are required by general airworthiness and operational regulations to
perform maintenance using methods that are acceptable to the FAA. We
consider those methods to be adequate to address any corrective actions
necessitated by the findings of ALS inspections required by this
proposed AD.

Airworthiness Limitations Based on Type Design

    The FAA recently became aware of an issue related to the
applicability of ADs that require incorporation of an ALS revision into
an operator's maintenance or inspection program.
    Typically, when these types of ADs are issued by civil aviation
authorities of other countries, they apply to all airplanes covered
under an identified type certificate (TC). The corresponding FAA AD
typically retains applicability to all of those airplanes.
    In addition, U.S. operators must operate their airplanes in an
airworthy condition, in accordance with 14 CFR 91.7(a). Included in
this obligation is the requirement to perform any maintenance or
inspections specified in the ALS, and in accordance with the ALS as
specified in 14 CFR 43.16 and 91.403(c), unless an alternative has been
approved by the FAA.
    When a type certificate is issued for a type design, the specific
ALS, including revisions, is a part of that type design, as specified
in 14 CFR 21.31(c).
    The sum effect of these operational and maintenance requirements is
an obligation to comply with the ALS defined in the type design
referenced in the manufacturer's conformity statement. This obligation
may introduce a conflict with an AD that requires a specific ALS
revision if new airplanes are delivered with a later revision as part
of their type design.
    To address this conflict, the FAA has approved alternative methods
of compliance (AMOCs) that allow operators to incorporate the most
recent ALS revision into their maintenance/inspection programs, in lieu
of the ALS revision required by the AD. This eliminates the conflict
and enables the operator to comply with both the AD and the type
design.
    However, compliance with AMOCs is normally optional, and we
recently became aware that some operators choose to retain the AD-
mandated ALS revision in their fleet-wide maintenance/inspection
programs, including those for new airplanes delivered with later ALS
revisions, to help standardize the maintenance of the fleet. To ensure
that operators comply with the applicable ALS revision for newly
delivered airplanes containing a later revision than that specified in
an AD, we plan to limit the applicability of ADs that mandate ALS
revisions to those airplanes that are subject to an earlier revision of
the ALS, either as part of the type design or as mandated by an earlier
AD. This proposed AD therefore would apply to Airbus Model A318, A319,
and A320 series airplanes, and Model A321-111, -112, -131, -211, -212,
-213, -231, -232, -251N, -253N, and -271N airplanes with an original
certificate of airworthiness or original export certificate of
airworthiness that was issued on or before the date of approval of the
ALS revision identified in this proposed AD. Operators of airplanes
with an original certificate of airworthiness or original export
certificate of airworthiness issued after that date must comply with
the airworthiness limitations specified as part of the approved type
design and referenced on the type certificate data sheet.

Costs of Compliance

    We estimate that this proposed AD affects 1,133 airplanes of U.S.
registry.
    We estimate the following costs to comply with this proposed AD:
    We have determined that revising the maintenance or inspection
program takes an average of 90 work-hours per operator, although this
figure may vary from operator to operator. In the past, we have
estimated that this action takes 1 work-hour per airplane. Since
operators incorporate maintenance or inspection program changes for
their affected fleet(s), we have determined that a per-operator
estimate is more accurate than a per-airplane estimate. Therefore, we
estimate the total cost per operator to be $7,650 (90 work-hours x $85
per work-hour).

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. Subtitle I, section 106, describes the
authority of the FAA Administrator. ``Subtitle VII: Aviation
Programs,'' describes in more detail the scope of the Agency's
authority.
    We are issuing this rulemaking under the authority described in
``Subtitle VII, Part A, Subpart III, Section 44701: General
requirements.'' Under that section, Congress charges the FAA with
promoting safe flight of civil aircraft in air commerce by prescribing
regulations for practices, methods, and procedures the Administrator
finds necessary for safety in air commerce. This regulation is within
the scope of that authority because it addresses an unsafe condition
that is likely to exist or develop on products identified in this
rulemaking action.
    This proposed AD is issued in accordance with authority delegated
by the Executive Director, Aircraft Certification Service, as
authorized by FAA Order 8000.51C. In accordance with that order,
issuance of ADs is normally a function of the Compliance and
Airworthiness Division, but during this transition period, the
Executive Director has delegated the authority to issue ADs applicable
to transport category airplanes to the Director of the System Oversight
Division.

Regulatory Findings

    We determined that this proposed AD would not have federalism
implications under Executive Order 13132. This proposed AD would not
have a substantial direct effect on the States, on the relationship
between the national Government and the States, or on the distribution
of power and responsibilities among the various levels of government.
    For the reasons discussed above, I certify this proposed
regulation:
    1. Is not a ``significant regulatory action'' under Executive Order
12866;
    2. Is not a ``significant rule'' under the DOT Regulatory Policies
and Procedures (44 FR 11034, February 26, 1979);
    3. Will not affect intrastate aviation in Alaska; and
    4. Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.

List of Subjects in 14 CFR Part 39

    Air transportation, Aircraft, Aviation safety, Incorporation by
reference, Safety.

The Proposed Amendment

    Accordingly, under the authority delegated to me by the
Administrator, the FAA proposes to amend 14 CFR part 39 as follows:

PART 39--AIRWORTHINESS DIRECTIVES

0
1. The authority citation for part 39 continues to read as follows:

    Authority:  49 U.S.C. 106(g), 40113, 44701.

Sec.  39.13  [Amended]

0
2. The FAA amends Sec.  39.13 by adding the following new airworthiness
directive (AD):

Airbus: Docket No. FAA-2018-0168; Product Identifier 2017-NM-135-AD.

(a) Comments Due Date

    We must receive comments by May 17, 2018.

(b) Affected ADs

    This AD affects AD 2017-19-24, Amendment 39-19054 (82 FR 44900,
September 27, 2017) (``AD 2017-19-24'').

(c) Applicability

    This AD applies to the Airbus airplanes identified in paragraphs
(c)(1) through (c)(4) of this AD, certificated in any category, with
an original certificate of airworthiness or original export
certificate of airworthiness issued on or before April 6, 2017.
    (1) Model A318-111, -112, -121, and -122 airplanes.
    (2) Model A319-111, -112, -113, -114, -115, -131, -132, and -133
airplanes.
    (3) Model A320-211, -212, -214, -216, -231, -232, -233, -251N,
and -271N airplanes.
    (4) Model A321-111, -112, -131, -211, -212, -213, -231, -232, -
251N, -253N, and -271N airplanes.

(d) Subject

    Air Transport Association (ATA) of America Code 05, Time Limits/
Maintenance Checks.

(e) Reason

    This AD was prompted by a revision of an airworthiness
limitations document that specifies more restrictive maintenance
requirements and airworthiness limitations. We are issuing this AD
to mitigate the risks associated with the effects of aging on
airplane systems. Such effects could change system characteristics,
leading to an increased potential for failure of certain life-
limited parts, and reduced structural integrity or controllability
of the airplane.

(f) Compliance

    Comply with this AD within the compliance times specified,
unless already done.

(g) Revision of Maintenance or Inspection Program

    Within 90 days after the effective date of this AD, revise the
maintenance or inspection program, as applicable, to incorporate
Airbus A318/A319/A320/A321 Airworthiness Limitations Section (ALS)
Part 4, ``System Equipment Maintenance Requirements (SEMR),''
Revision 05, dated April 6, 2017. The initial compliance time for
doing the revised actions is at the applicable time specified in
Airbus A318/A319/A320/A321 Airworthiness Limitations Section (ALS)
Part 4, ``System Equipment Maintenance Requirements (SEMR),''
Revision 05, dated April 6, 2017.

(h) No Alternative Actions or Intervals

    After the maintenance or inspection program has been revised as
required by paragraph (g) of this AD, no alternative actions (e.g.,
inspections) or intervals may be used unless the actions and
intervals are approved as an alternative method of compliance (AMOC)
in accordance with the procedures specified in paragraph (j)(1) of
this AD.

(i) Terminating Action for AD 2017-19-24

    Accomplishing the actions required by this AD terminates all
requirements of AD 2017-19-24.

(j) Other FAA AD Provisions

    The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager,
International Section, Transport Standards Branch, FAA, has the
authority to approve AMOCs for this AD, if requested using the
procedures found in 14 CFR 39.19. In accordance with 14 CFR 39.19,
send your request to your principal inspector or local Flight
Standards District Office, as appropriate. If sending information
directly to the International Section, send it to the attention of
the person identified in paragraph (k)(2) of this AD. Information
may be emailed to: [email protected]. Before using any
approved AMOC, notify your appropriate principal inspector, or
lacking a principal inspector, the manager of the local flight
standards district office/certificate holding district office.
    (2) Contacting the Manufacturer: For any requirement in this AD
to obtain corrective actions from a manufacturer, the action must be
accomplished using a method approved by the Manager, International
Section, Transport Standards Branch, FAA; or the European Aviation
Safety Agency (EASA); or Airbus's EASA Design Organization Approval
(DOA). If approved by the DOA, the approval must include the DOA-
authorized signature.

(k) Related Information

    (1) Refer to Mandatory Continuing Airworthiness Information
(MCAI) EASA Airworthiness Directive 2017-0170, dated September 7,
2017, for related information. This MCAI may be found in the AD
docket on the internet at http://www.regulations.gov by searching
for and locating Docket No. FAA-2018-0168.
    (2) For more information about this AD, contact Sanjay Ralhan,
Aerospace Engineer, International Section, Transport Standards
Branch, FAA, 2200 South 216th St., Des Moines, WA 98198; telephone
and fax<PHONE_NUMBER>.
    (3) For service information identified in this AD, contact
Airbus, Airworthiness Office--EIAS, 1 Rond Point Maurice Bellonte,
31707 Blagnac Cedex, France; telephone +33 5 61 93 36 96; fax +33 5
61 93 44 51; email [email protected]; internet http://www.airbus.com. You may view this service information at the FAA,
Transport Standards Branch, 2200 South 216th St., Des Moines, WA.
For information on the availability of this material at the FAA,
call<PHONE_NUMBER>.

    Issued in Des Moines, Washington, on March 22, 2018.
Michael Kaszycki,
Acting Director, System Oversight Division, Aircraft Certification
Service.
[FR Doc. 2018-06590 Filed 3-30-18; 8:45 am]
 BILLING CODE 4910-13-P


[Federal Register Volume 76, Number 159 (Wednesday, August 17, 2011)]
[Rules and Regulations]
[Pages 50904-50913]
[FR Doc No: 2011-20839]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2011-0481; FRL-8874-9]

Thiamethoxam; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of
thiamethoxam in or on peanut; peanut, hay; peanut, meal; alfalfa,
forage; alfalfa, hay; and in food/feed commodities in food/feed
handling establishments. Syngenta Crop Protection, Inc. requested these
tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective August 17, 2011. Objections and
requests for hearings must be received on or before October 17, 2011,
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: This final rule addresses three petitions for tolerances.
EPA has established a docket under docket identification (ID) number
EPA-HQ-OPP-2011-0481 which contains only this final rule and is a
summary docket used to lead the user to the individual docket
established for each of the three petitions for tolerances addressed in
this final rule: EPA-HQ-OPP-2010-0041 (peanut), EPA-HQ-OPP-2010-0324
(alfalfa), EPA-HQ-OPP-2010-0602 (food/feed commodities in food/feed
handling establishments). The user should look in the individual
dockets to view the previous Federal Register publications and
supporting documents for each tolerance petition. All documents in the
docket are listed in the docket index available at http://www.regulations.gov. Although listed in the index, some information is
not publicly available, e.g., Confidential Business Information (CBI)
or other information whose disclosure is restricted by statute. Certain
other material, such as copyrighted material, is not placed on the
Internet and will be publicly available only in hard copy form.
Publicly available docket materials are available in the electronic
docket at http://www.regulations.gov, or, if only available in hard
copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac
Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The Docket
Facility is open from 8:30 a.m. to 4 p.m., Monday through Friday,
excluding legal holidays. The Docket

Facility telephone number is<PHONE_NUMBER>.

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

I. General Information

A. Does this action apply to me?

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

B. How can I 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 http://ecfr.gpoaccess.gov/cgi/t/text/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

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

    Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an
objection to any aspect of this regulation and may also request a
hearing on those objections. You must file your objection or request a
hearing on this regulation in accordance with the instructions provided
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify
docket ID number EPA-HQ-OPP-2011-0481 (summary docket) or the
individual docket for a specific new use: EPA-HQ-OPP-2010-0041
(peanut), EPA-HQ-OPP-2010-0324 (alfalfa), or EPA-HQ-OPP-2010-0602
(food/feed commodities in food/feed handling establishments) 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 October 17, 2011. 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 that does not contain any 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 a copy of
your non-CBI objection or hearing request, identified by docket ID
number EPA-HQ-OPP-2011-0481 (summary docket) or the individual docket
for a specific new use: EPA-HQ-OPP-2010-0041 (peanut), EPA-HQ-OPP-2010-
0324 (alfalfa), -HQ-OPP-2010-0602 (food/feed commodities in food/feed
handling establishments) by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the online instructions for submitting comments.
     Mail: Office of Pesticide Programs (OPP) Regulatory Public
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001.
     Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only
accepted during the Docket Facility's normal hours of operation (8:30
a.m. to 4 p.m., Monday through Friday, excluding legal holidays).
Special arrangements should be made for deliveries of boxed
information. The Docket Facility telephone number is<PHONE_NUMBER>.

II. Summary of Petitioned-For Tolerance

    This final rule addresses three petitions for tolerances.
    1. Peanut. In the Federal Register of March 24, 2010 (75 FR 14154)
(FRL-8815-6), EPA issued a notice pursuant to section 408(d)(3) of
FFDCA, 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide
petition (PP 9F7657) by Syngenta Crop Protection, Inc., P.O. Box 18300,
Greensboro, NC 27419. The petition requested that 40 CFR 180.565 be
amended by establishing tolerances for residues of the insecticide
thiamethoxam, 3-[(2-chloro-5-thiazolyl)methyl]tetrahydro-5-methyl-N-
nitro-4H-1,3,5-oxadiazin-4-imine and its metabolite, N-(2-chloro-
thiazol-5-ylmethyl)-N'-methyl-N'-nitro-guanidine, in or on peanut at
0.05 parts per million (ppm) and peanut hay at 0.25 ppm. That notice
referenced a summary of the petition prepared by Syngenta Crop
Protection, Inc., the registrant, which is available in the docket,
http://www.regulations.gov. There were no comments received in response
to the notice of filing.
    Based upon review of the data supporting the petition, EPA has
determined that a tolerance must also be established for peanut meal at
0.15 ppm. The reasons for this change are explained in Unit IV.D.
    2. Alfalfa. In the Federal Register of June 8, 2010 (75 FR 32463)
(FRL-8827-5), EPA issued a notice pursuant to section 408(d)(3) of
FFDCA, 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide
petition (PP 0F7707) by Syngenta Crop Protection, Inc., P.O. Box 18300,
Greensboro, NC 27419. The petition requested that 40 CFR 180.565 be
amended by establishing tolerances for residues of the insecticide
thiamethoxam, 3-[(2-chloro-5-thiazolyl)methyl]tetrahydro-5-methyl-N-
nitro-4H-1,3,5-oxadiazin-4-imine and its metabolite, N-(2-chloro-
thiazol-5-ylmethyl)-N'-methyl-N'-nitro-guanidine, in or on alfalfa,
forage at 0.05 ppm and alfalfa, hay at 0.12 ppm. That notice referenced
a summary of the petition prepared by Syngenta Crop Protection, Inc.,
the registrant, which is available in the docket, http://www.regulations.gov. One comment was received from a private citizen
who opposes any pesticide that leaves a residue on food. The Agency has
received this same comment from this commenter on numerous previous
occasions and rejects it for reasons previously stated. 70 FR 1349,
1354 (January 7, 2005).
    3. Food/feed commodities in food/feed handling establishments. In
the Federal Register of June 22, 2011 (76 FR 36479) (FRL-8878-1), EPA
issued a notice pursuant to section 408(d)(3) of FFDCA, 21 U.S.C.
346a(d)(3), announcing the filing of a pesticide petition (PP 0F7734)
by Syngenta Crop Protection, Inc., P.O. Box 18300, Greensboro, NC
27419. The petition requested that 40 CFR 180.565 be amended by
establishing tolerances for residues of the insecticide thiamethoxam,
3-[(2-chloro-5-thiazolyl)methyl]tetrahydro-5-methyl-N-nitro-4H-1,3,5-
oxadiazin-4-imine and its metabolite, N-(2-chloro-thiazol-5-ylmethyl)-
N'-methyl-N'-nitro-guanidine, in or on food commodities and feed

commodities (other than those covered by a higher tolerance as a result
of use on growing crops) in food/feed handling establishments at 0.01
ppm. That notice referenced a summary of the petition prepared by
Syngenta Crop Protection, Inc., the registrant, which is available in
the docket, http://www.regulations.gov. One comment was received from a
private citizen who opposes any pesticide that leaves a residue on
food. The Agency has received this same comment from this commenter on
numerous previous occasions and rejects it for reasons previously
stated. 70 FR 1349, 1354 (January 7, 2005).
    Based upon review of the data supporting the petition, EPA has
determined that the tolerance for food commodities and feed commodities
(other than those covered by a higher tolerance as a result of use on
growing crops) in food/feed handling establishments be raised to 0.02
ppm. The reasons for this change 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 section 408(b)(2)(D) of FFDCA, and the factors
specified in section 408(b)(2)(D) of FFDCA, EPA has reviewed the
available scientific data and other relevant information in support of
this action. EPA has sufficient data to assess the hazards of and to
make a determination on aggregate exposure for thiamethoxam including
exposure resulting from the tolerances established by this action.
EPA's assessment of exposures and risks associated with thiamethoxam
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.
    Thiamethoxam shows toxicological effects primarily in the liver,
kidney, testes, and hematopoietic system. In addition, developmental
neurological effects were observed in rats. This developmental effect
is being used to assess risks associated with acute exposures to
thiamethoxam, and the liver and testicular effects are the bases for
assessing longer term exposures. Although thiamethoxam causes liver
tumors in mice, the Agency has classified thiamethoxam as ``not likely
to be carcinogenic to humans'' based on convincing evidence that a non-
genotoxic mode of action for liver tumors was established in the mouse
and that the carcinogenic effects are a result of a mode of action
dependent on sufficient amounts of a hepatotoxic metabolite produced
persistently. The non-cancer (chronic) assessment is sufficiently
protective of the key events (perturbation of liver metabolism,
hepatotoxicity/regenerative proliferation) in the animal mode of action
for cancer. Refer to the Federal Register of June 22, 2007 (72 FR
34401) (FRL-8133-6) for more information regarding the cancer
classification of thiamethoxam.
    Thiamethoxam produces a metabolite known as CGA-322704 (referred to
in the remainder of this rule as clothianidin). Clothianidin is also
registered as a pesticide. While some of the toxic effects observed
following testing with the thiamethoxam and clothianidin are similar,
the available information indicates that thiamethoxam and clothianidin
have different toxicological effects in mammals and should be assessed
separately. A separate risk assessment of clothianidin has been
completed in conjunction with the registration of clothianidin. The
most recent assessments, which provide details regarding the toxicology
of clothianidin, are available in the docket EPA-HQ-OPP-2008-0945, at
http:///www.regulations.gov. Refer to the documents ``Clothianidin:
Human Health Risk Assessment for Proposed Uses on Berries (Group 13-
07H), Brassica Vegetables (Group 5), Cotton, Cucurbit Vegetables (Group
9), Fig, Fruiting Vegetables (Group 8), Leafy Green Vegetables (Group
4A), Peach, Pomegranate, Soybean, Tree Nuts (Group 14), and Tuberous
and Corm Vegetables (Group 1C)''; and ``Clothianidin: Human Health Risk
Assessment for Proposed Seed Treatment Uses on Root and Tuber
Vegetables (Group 1), Bulb Vegetables (Group 3), Leafy Green Vegetables
(Group 4A), Brassica Leafy Vegetables (Group 5), Fruiting Vegetables
(Group 8), Cucurbit Vegetables (Group 9), and Cereal Grains (Group 15,
except rice).''
    Specific information on the studies received and the nature of the
adverse effects caused by thiamethoxam as well as the no-observed-
adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-
level (LOAEL) from the toxicity studies are discussed in the final rule
published in the Federal Register of June 22, 2007.

B. Toxicological Points of Departure/Levels of Concern

    Once a pesticide's toxicological profile is determined, EPA
identifies toxicological points of departure (POD) 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 thiamethoxam used for
human risk assessment is discussed in Unit III.B. of the final rule
published in the Federal Register of June 22, 2007.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to thiamethoxam, EPA considered exposure under the petitioned-
for tolerances as well as all existing thiamethoxam tolerances in 40
CFR 180.565. EPA assessed dietary exposures from thiamethoxam in food
as follows.
    For both acute and chronic exposure assessments for thiamethoxam,
EPA combined residues of clothianidin coming from thiamethoxam with
residues of thiamethoxam per se. As discussed in this unit,
thiamethoxam's major metabolite is CGA-322704, which is also the
registered active ingredient clothianidin. Available information
indicates that thiamethoxam and clothianidin have different
toxicological effects in mammals and should be assessed separately;
however, these exposure assessments for this action incorporated the
total residue of thiamethoxam and clothianidin from use of thiamethoxam
because the total residue for each commodity for which thiamethoxam has
a tolerance has not been separated between thiamethoxam and its
clothianidin metabolite. The combining of these residues, as was done
in this assessment, results in highly conservative estimates of dietary
exposure and risk. A separate assessment was done for clothianidin.
    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 thiamethoxam. In estimating acute
dietary exposure, EPA used food consumption information from the United
States Department of Agriculture (USDA) 1994-1996 and 1998 Nationwide
Continuing Surveys of Food Intake by Individuals (CSFII). As to residue
levels in food, EPA assumed tolerance-level residues of thiamethoxam
and clothianidin. It was also assumed that 100% of crops with
registered or requested uses of thiamethoxam and 100% of crops with
registered or requested uses of clothianidin are treated.
    ii. Chronic exposure. In conducting the chronic dietary exposure
assessment EPA used the food consumption data from the USDA 1994-1996
and 1998 CSFII. As to residue levels in food, EPA assumed tolerance
level and/or anticipated residues from thiamethoxam field trials. It
was also assumed that 100% of crops with registered or requested uses
of thiamethoxam and 100% of crops with registered or requested uses of
clothianidin are treated.
    A complete listing of the inputs used in these assessments can be
found in the following documents: ``Thiamethoxam. Acute and Chronic
Aggregate Dietary (Food and Drinking Water) Exposure and Risk
Assessments for the Section 3 Registration as a Seed Treatment for
Alfalfa and Peanuts, and for Use in Food Handling Establishments,''
available in the dockets EPA-HQ-OPP-2009-0041, EPA-HQ-OPP-2010-0324,
and EPA-HQ-OPP-2010-0602, at http://www.regulations.gov; and
``Clothianidin Acute and Chronic Aggregate Dietary (Food and Drinking
Water) Exposure and Risk Assessments,'' available in the docket EPA-HQ-
OPP-2008-0771, at http://www.regulations.gov.
    iii. Cancer. EPA concluded that thiamethoxam is ``not likely to be
carcinogenic to humans'' based on convincing evidence that a non-
genotoxic mode of action for liver tumors was established in the mouse,
and that the carcinogenic effects are a result of a mode of action
dependent on sufficient amounts of a hepatotoxic metabolite produced
persistently. The non-cancer (chronic) assessment is sufficiently
protective of the key events (perturbation of liver metabolism,
hepatotoxicity/regenerative proliferation) in the animal mode of action
for cancer and thus a separate exposure assessment pertaining to cancer
risk is not necessary. Because clothianidin is not expected to pose a
cancer risk, a quantitative dietary exposure assessment for the
purposes of assessing cancer risk was not conducted.
    iv. Anticipated residue and percent crop treated (PCT) information.
Section 408(b)(2)(E) of FFDCA authorizes EPA to use available data and
information on the anticipated residue levels of pesticide residues in
food and the actual levels of pesticide residues that have been
measured in food. If EPA relies on such information, EPA must require
pursuant to FFDCA section 408(f)(1) that data be provided 5 years after
the tolerance is established, modified, or left in effect,
demonstrating that the levels in food are not above the levels
anticipated. For the present action, EPA will issue such data call-ins
as are required by FFDCA section 408(b)(2)(E) and authorized under
FFDCA section 408(f)(1). Data will be required to be submitted no later
than 5 years from the date of issuance of these tolerances.
    2. Dietary exposure from drinking water. Thiamethoxam is expected
to be persistent and mobile in terrestrial and aquatic environments.
These fate properties suggest that thiamethoxam has a potential to move
into surface water and shallow ground water. The Agency lacks
sufficient monitoring data to complete a comprehensive dietary exposure
analysis and risk assessment for thiamethoxam in drinking water.
Because the Agency does not have comprehensive monitoring data, the
Agency used screening level water exposure models in the dietary
exposure analysis and risk assessment for thiamethoxam in drinking
water. These simulation models take into account data on the physical,
chemical, and fate/transport characteristics of thiamethoxam. 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.
    For surface water, the estimated drinking water concentrations
(EDWCs) are based on thiamethoxam concentrations in water from rice
paddies and cranberry bogs that drains into adjacent surface water
bodies (often referred to as ``tail water''). Because the uses on rice
and cranberries involve flooding, for which Pesticide Root Zone Model/
Exposure/Analysis Modeling System (PRZM/EXAMS) is not currently
parameterized, these uses were assessed using the modified Tier I Rice
Model and the Provisional Cranberry Model. Exposure estimates were
refined with a default percent cropped area factor of 87%. The Tier I
Rice Model is expected to generate conservative EDWCs that exceed peak
measured concentrations of pesticides in water bodies well downstream
of rice paddies by less than one order of magnitude to multiple orders
of magnitude.
    For ground water, the EDWCs are based on thiamethoxam
concentrations resulting from use on dry bulb onions. Exposure in
ground water due to leaching was assessed with the Screening
Concentration in Groundwater (SCI-GROW) models.
    Based on the Tier I Rice Model and SCI-GROW models, the EDWCs of
thiamethoxam for acute exposures are 131.77 parts per billion (ppb) for
tail water (i.e. surface water) and 4.66 ppb for ground water. The
EDWCs for chronic exposures for non-cancer assessments are 11.31 ppb
for tail water and 4.66 ppb for ground water. Modeled estimates of
drinking water concentrations were directly entered into the dietary
exposure model. The most conservative EDWCs in both the acute and
chronic exposure scenarios were for rice tail water, and represent
worst case scenarios. Therefore, for the acute dietary risk assessments
for

thiamethoxam, the upper-bound EDWC value of 131.77 ppb was used to
assess the contribution to drinking water. For the chronic dietary risk
assessments for thiamethoxam, the upper-bound EDWC value of 11.31 ppb
was used to assess the contribution to drinking water.
    The registrant has conducted small-scale prospective ground water
studies in several locations in the United States to investigate the
mobility of thiamethoxam in a vulnerable hydrogeological setting. A
review of those data show that generally, residues of thiamethoxam, as
well as clothianidin, are below the limit of quantification (0.05 ppb).
When quantifiable residues are found, they are sporadic and at low
levels. The maximum observed residue levels from any monitoring well
were 1.0 ppb for thiamethoxam and 0.73 ppb for clothianidin. These
values are well below the modeled estimates summarized in this unit,
indicating that the modeled estimates are, in fact, protective of what
actual exposures are likely to be.
    Clothianidin is not a significant degradate of thiamethoxam in
surface or ground water sources of drinking water and, therefore, was
not included in the EDWCs used in the thiamethoxam dietary assessments.
For the clothianidin assessments, the acute EDWC value of 7.29 ppb for
clothianidin was incorporated into the acute dietary assessment and the
chronic EDWC value of 5.88 ppb for clothianidin was incorporated into
the chronic dietary assessment.
    A complete listing of the inputs used in these assessments can be
found in the following documents: ``Thiamethoxam. Acute and Chronic
Aggregate Dietary (Food and Drinking Water) Exposure and Risk
Assessments for the Section 3 Registration as a Seed Treatment for
Alfalfa and Peanuts, and for Use in Food Handling Establishments,''
available in the dockets EPA-HQ-OPP-2009-0041, EPA-HQ-OPP-2010-0324,
and EPA-HQ-OPP-2010-0602, at http://www.regulations.gov; and
``Clothianidin Acute and Chronic Aggregate Dietary (Food and Drinking
Water) Exposure and Risk Assessments,'' available in the docket EPA-HQ-
OPP- 2008-0771, at http://www.regulations.gov.
    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).
    Thiamethoxam is currently registered for the following uses that
could result in residential exposures: Turfgrass on golf courses,
residential lawns, commercial grounds, parks, playgrounds, athletic
fields, landscapes, interiorscapes, and sod farms; indoor crack and
crevice or spot treatments to control insects in residential settings.
EPA assessed residential exposure using the following assumptions:
Thiamethoxam is registered for use on turfgrass (on golf courses,
residential lawns, commercial grounds, parks, playgrounds, athletic
fields, landscapes, interiorscapes and sod farms) and for indoor use to
control insects in residential settings. Thiamethoxam is applied by
commercial applicators only. Therefore, exposures resulting to
homeowners from applying thiamethoxam were not assessed. However,
entering areas previously treated with thiamethoxam could lead to
exposures for adults and children. As a result, risk assessments have
been completed for postapplication scenarios.
    Short-term exposures (1 to 30 days of continuous exposure) may
occur as a result of activities on treated turf. Short-term and
intermediate-term exposures (30 to 90 days of continuous exposure) may
occur as a result of entering indoor areas previously treated with a
thiamethoxam indoor crack and crevice product. The difference between
short-and intermediate-term aggregate risk is the frequency of hand-to-
mouth events for children. For short-term exposure there are 20 events
per hour and for intermediate-term exposure there are 9.5 events per
hour. The doses and end-points for short- and intermediate-term
aggregate risk are the same.
    EPA combined all non-dietary sources of post application exposure
to obtain an estimate of potential combined exposure. These scenarios
consisted of adult and toddler dermal postapplication exposure and oral
(hand-to-mouth) exposures for toddlers. Since postapplication scenarios
for turf occur outdoors, the potential for inhalation exposure is
negligible and therefore does not require an inhalation exposure
assessment. Since thiamethoxam has a very low vapor pressure (6.6 x
10-9 Pa @ 25 [deg]C), inhalation exposure is also expected
to be negligible as a result of indoor crack and crevice use.
Therefore, a quantitative postapplication inhalation exposure
assessment was not performed.
    A complete listing of the inputs used in these assessments can be
found in the following documents: ``Thiamethoxam: Occupational and
Residential Exposure/Risk Assessment for Proposed Section 3
Registration for Seed Treatment Use on Peanut and Alfalfa'' available
in the dockets EPA-HQ-OPP-2010-0041 and EPA-HQ-OPP-2010-0324 at http://www.regulations.gov; and ``Thiamethoxam: Occupational and Residential
Exposure/Risk Assessment for Proposed Section 3 Registration for Use in
Food/Feed Handling Establishments'' available in the docket EPA-HQ-OPP-
2010-0602 at http://www.regulations.gov.
    Thiamethoxam use on turf or as an indoor crack and crevice or spot
treatment does not result in significant residues of clothianidin. In
addition, clothianidin residential and aggregate risks are not of
concern. For further details, refer to the documents ``Clothianidin:
Human Health Risk Assessment for Proposed Uses on Berries (Group 13-
07H), Brassica Vegetables (Group 5), Cotton, Cucurbit Vegetables (Group
9), Fig, Fruiting Vegetables (Group 8), Leafy Green Vegetables (Group
4A), Peach, Pomegranate, Soybean, Tree Nuts (Group 14), and Tuberous
and Corm Vegetables (Group 1C)''; and ``Clothianidin: Human Health Risk
Assessment for Proposed Seed Treatment Uses on Root and Tuber
Vegetables (Group 1), Bulb Vegetables (Group 3), Leafy Green Vegetables
(Group 4A), Brassica Leafy Vegetables (Group 5), Fruiting Vegetables
(Group 8), Cucurbit Vegetables (Group 9), and Cereal Grains (Group 15,
except rice),'' available in the docket EPA-HQ-OPP- 2008-0945, at
http://www.regulations.gov.
    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.''
    Thiamethoxam is a member of the neonicotinoid class of pesticides
and produces, as a metabolite, another neonicotinoid, clothianidin.
Structural similarities or common effects do not constitute a common
mechanism of toxicity. Evidence is needed to establish that the
chemicals operate by the same, or essentially the same sequence of
major biochemical events (EPA, 2002). Although clothianidin and
thiamethoxam bind selectively to insect nicotinic acetylcholine
receptors (nAChR), the specific binding site(s)/receptor(s) for
clothianidin,

thiamethoxam, and the other neonicotinoids are unknown at this time.
Additionally, the commonality of the binding activity itself is
uncertain, as preliminary evidence suggests that clothianidin operates
by direct competitive inhibition, while thiamethoxam is a non-
competitive inhibitor. Furthermore, even if future research shows that
neonicotinoids share a common binding activity to a specific site on
insect nicotinic acetylcholine receptors, there is not necessarily a
relationship between this pesticidal action and a mechanism of toxicity
in mammals. Structural variations between the insect and mammalian
nAChRs produce quantitative differences in the binding affinity of the
neonicotinoids towards these receptors, which, in turn, confers the
notably greater selective toxicity of this class towards insects,
including aphids and leafhoppers, compared to mammals. While the
insecticidal action of the neonicotinoids is neurotoxic, the most
sensitive regulatory endpoint for thiamethoxam is based on unrelated
effects in mammals, including effects on the liver, kidney, testes, and
hematopoietic system.
    Additionally, the most sensitive toxicological effect in mammals
differs across the neonicotinoids (e.g., testicular tubular atrophy
with thiamethoxam; mineralized particles in thyroid colloid with
imidacloprid).
    Thus, EPA has not found thiamethoxam or clothianidin to share a
common mechanism of toxicity with any other substances. For the
purposes of this tolerance action, therefore, EPA has assumed that
thiamethoxam and clothianidin do not have a common mechanism of
toxicity with other substances. For information regarding EPA's efforts
to determine which chemicals have a common mechanism of toxicity and to
evaluate the cumulative effects of such chemicals, see EPA's Web site
at http://www.epa.gov/pesticides/cumulative.

D. Safety Factor for Infants and Children

    1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA
shall apply an additional tenfold (10X) margin of safety for infants
and children in the case of threshold effects to account for prenatal
and postnatal toxicity and the completeness of the database on toxicity
and exposure unless EPA determines based on reliable data that a
different margin of safety will be safe for infants and children. This
additional margin of safety is commonly referred to as the FQPA Safety
Factor (SF). In applying this provision, EPA either retains the default
value of 10X, or uses a different additional safety factor when
reliable data available to EPA support the choice of a different
factor.
    2. Prenatal and postnatal sensitivity. In the developmental
studies, there is no evidence of increased quantitative or qualitative
susceptibility of rat or rabbit fetuses to in utero exposure to
thiamethoxam. The developmental NOAELs are either higher than or equal
to the maternal NOAELs. The toxicological effects in fetuses do not
appear to be any more severe than those in the dams or does. In the rat
DNT study, there was no quantitative evidence of increased
susceptibility.
    There is evidence of increased quantitative susceptibility for male
pups in two 2-generation reproductive studies. In one study, there are
no toxicological effects in the dams whereas for the pups, reduced
bodyweights are observed at the highest dose level, starting on day 14
of lactation. This contributes to an overall decrease in bodyweight
gain during the entire lactation period. Additionally, reproductive
effects in males appear in the F1 generation in the form of increased
incidence and severity of testicular tubular atrophy. These data are
considered to be evidence of increased quantitative susceptibility for
male pups (increased incidence of testicular tubular atrophy at 1.8
milligrams/kilogram/day (mg/kg/day)) when compared to the parents
(hyaline changes in renal tubules at 61 mg/kg/day; NOAEL is 1.8 mg/kg/
day).
    In a more recent 2-generation reproduction study, the most
sensitive effect was sperm abnormalities at 3 mg/kg/day (the NOAEL is
1.2 mg/kg/day) in the F1 males. This study also indicates increased
susceptibility for the offspring for this effect.
    Although there is evidence of increased quantitative susceptibility
for male pups in both reproductive studies, NOAELs and LOAELs were
established in these studies and the Agency selected the NOAEL for
testicular effects in F1 pups as the basis for risk assessment. The
Agency has confidence that the NOAEL selected for risk assessment is
protective of the most sensitive effect (testicular effects) for the
most sensitive subgroup (pups) observed in the toxicological database.
    3. Conclusion. i. In the final rule published in the Federal
Register of January 5, 2005 (70 FR 708) (FRL-7689-7), EPA had
previously determined that the FQPA SF should be retained at 10X for
thiamethoxam, based on the following factors: Effects on endocrine
organs observed across species; significant decrease in alanine amino
transferase levels in companion animal studies and in dog studies; the
mode of action of this chemical in insects (interferes with the
nicotinic acetylcholine receptors of the insect's nervous system); the
transient clinical signs of neurotoxicity in several studies across
species; and the suggestive evidence of increased quantitative
susceptibility in the rat reproduction study. Since that determination,
EPA has received and reviewed a city DNT study in rats, and an
additional reproduction study in rats.
    Taking the results of these studies into account, as well as the
rest of the data on thiamethoxam, EPA has determined that reliable data
show the safety of infants and children would be adequately protected
if the FQPA SF were reduced to 1X (June 23, 2010, 75 FR 35653; FRL-
8830-4); (June 22, 2007, 72 FR 34401). That decision is based on the
following findings:
    a. The toxicity database for thiamethoxam is largely complete,
including acceptable/guideline developmental toxicity, 2-generation
reproduction, and DNT studies designed to detect adverse effects on the
developing organism, which could result from the mechanism that may
have produced the decreased alanine amino transferase levels.
    The registrant must now submit, as a condition of registration, an
immunotoxicity study.
    This study is now required under 40 CFR part 158.
    The available data for thiamethoxam show the potential for
immunotoxic effects. In the subchronic dog study, leukopenia (decreased
white blood cells) was observed in females only, at the highest dose
tested (HDT) of 50 mg/kg/day; the NOAEL for this effect was 34 mg/kg/
day. The overall study NOAEL was 9.3 mg/kg/day in females (8.2 mg/kg/
day in males) based on hematology and other clinical chemistry findings
at the LOAEL of 34 mg/kg/day (32 mg/kg/day in males). In the subchronic
mouse study, decreased spleen weights were observed in females at 626
mg/kg/day; the NOAEL for this effect was the next lowest dose of 231
mg/kg/day. The overall study NOAEL was 1.4 mg/kg/day (males) based on
increased hepatocyte hypertrophy observed at the LOAEL of 14.3 mg/kg/
day. The decreased absolute spleen weights were considered to be
treatment related, but were not statistically significant at 626 mg/kg/
day or at the HDT of 1,163 mg/kg/day. Since spleen weights were not
decreased relative to body weights, the absolute decreases may have
been related to the

decreases in body weight gain observed at higher doses.
    Overall, the Agency has a low concern for the potential for
immunotoxicity related to these effects for the following reasons: In
general, the Agency does not consider alterations in hematology
parameters alone to be a significant indication of potential
immunotoxicity. In the case of thiamethoxam, high-dose females in the
subchronic dog study had slight microcytic anemia as well as leukopenia
characterized by reductions in neutrophils, lymphocytes and monocytes;
the leukopenia was considered to be related to the anemic response to
exposure. Further, endpoints and doses selected for risk assessment are
protective of the observed effects on hematology. Spleen weight
decreases, while considered treatment-related, were associated with
decreases in body weight gain, and were not statistically significant.
In addition, spleen weight changes occurred only at very high doses,
more than 70 times higher than the doses selected for risk assessment.
Therefore, an additional 10X safety factor is not warranted for
thiamethoxam at this time.
    b. For the reasons discussed in Unit III.D.2., there is low concern
for an increased susceptibility in the young.
    c. Although there is evidence of neurotoxicity after acute exposure
to thiamethoxam at doses of 500 mg/kg/day including drooped palpebral
closure, decrease in rectal temperature and locomotor activity and
increase in forelimb grip strength, no evidence of neuropathology was
observed. These effects occurred at doses at least fourteen-fold and
416-fold higher than the doses used for the acute, and chronic risk
assessments, respectively; thus, there is low concern for these effects
since it is expected that the doses used for regulatory purposes would
be protective of the effects noted at much higher doses.
    In the DNT study, there was no evidence of neurotoxicity in the
dams exposed up to 298.7 mg/kg/day; a dose that was associated with
decreases in body weight gain and food consumption. In pups exposed to
298.7 mg/kg/day, there were significant reductions in absolute brain
weight and size (i.e., length and width of the cerebellum was less in
males on day 12, and there were significant decreases in Level 3-5
measurements in males and in Level 4-5 measurements in females on day
63). However, there is low concern for this increased qualitative
susceptibility observed in the DNT study because the doses and
endpoints selected for risk assessment are protective of the effects in
the offspring. As noted previously, the Agency selected the NOAEL for
testicular effects in F1 pups based on two reproductive toxicity
studies for risk assessment to be protective of all sensitive
subpopulations.
    d. There are no residual uncertainties identified in the exposure
databases. The dietary food exposure assessments were performed using
tolerance-level and/or anticipated residues that are based on reliable
field trial data observed in the thiamethoxam field trials. Although
there is available information indicating that thiamethoxam and
clothianidin have different toxicological effects in mammals and should
be assessed separately, the residues of each have been combined in
these assessments to ensure that the estimated exposures of
thiamethoxam do not underestimate actual potential thiamethoxam
exposures. An assumption of 100 PCT was made for all foods evaluated in
the assessments. For the acute and chronic assessments, the EDWCs of
131.77 ppb and 11.3 ppb, respectively, were used to estimate exposure
via drinking water. Compared to the results from small scale
prospective ground water studies where the maximum observed residue
levels from any monitoring well were 1.0 ppb for thiamethoxam and 0.73
ppb for clothianidin, the modeled estimates are protective of what
actual exposures are likely to be. Similarly conservative residential
standards of procedures, as well as a chemical specific turf transfer
residue (TTR) study were used to assess postapplication exposure to
children and incidental oral exposure of toddlers. These assessments
will not underestimate the exposure and risks posed by thiamethoxam.
    ii. In the final rule published in the Federal Register of February
6, 2008 (73 FR 6851) (FRL-8346-9), EPA had previously determined that
the FQPA SF for clothianidin should be retained at 10X because EPA had
required the submission of a DNT study to address the combination of
evidence of decreased absolute and adjusted organ weights of the thymus
and spleen in multiple studies in the clothianidin database, and
evidence showing that juvenile rats in the 2-generation reproduction
study appear to be more susceptible to these potential immunotoxic
effects. In the absence of a DNT study, EPA concluded that there was
sufficient uncertainty regarding immunotoxic effects in the young that
the 10X FQPA factor should be retained as a database uncertainty
factor.
    Since that determination, EPA has received and reviewed an
acceptable/guideline DNT study, which demonstrated no treatment-related
effects. Taking the results of this study into account, as well as the
rest of the data on clothianidin, EPA has determined that reliable data
show the safety of infants and children would be adequately protected
if the FQPA SF for clothianidin were reduced to 1X (February 11, 2011,
76 FR 7712) (FRL-8858-3). That decision is based on the following
findings:
    a. The toxicity database for clothianidin is complete. As noted,
the prior data gap concerning developmental immunotoxicity has been
addressed by the submission of an acceptable DNT study.
    b. A rat DNT study is available and shows evidence of increased
quantitative susceptibility of offspring. However, EPA considers the
degree of concern for the DNT study to be low for prenatal and
postnatal toxicity because the NOAEL and LOAEL were well characterized,
and the doses and endpoints selected for risk assessment are protective
of the observed susceptibility; therefore, there are no residual
concerns regarding effects in the young.
    c. While the rat multi-generation reproduction study showed
evidence of increased quantitative susceptibility of offspring compared
to adults, the degree of concern is low because the study NOAEL and
LOAEL have been selected for risk assessment purposes for relevant
exposure routes and durations. In addition, the potential immunotoxic
effects observed in the study have been further characterized with the
submission of a DNT study that showed no evidence of susceptibility. As
a result, there are no concerns or residual uncertainties for prenatal
and postnatal toxicity after establishing toxicity endpoints and
traditional UFs to be used in the risk assessment for clothianidin.
    d. There are no residual uncertainties identified in the exposure
databases. The dietary food exposure assessments were performed based
on assumptions that were judged to be highly conservative and health-
protective for all durations and population subgroups, including
tolerance-level residues, adjustment factors from metabolite data,
empirical processing factors, and 100 PCT for all commodities.
Additionally, EPA made conservative (protective) assumptions in the
ground water and surface water modeling used to assess exposure to
clothianidin in drinking water. EPA used similarly conservative
assumptions to assess post-application exposure of children and adults
as well as incidental oral exposure of toddlers. These assessments will
not

underestimate the exposure and risks posed by clothianidin.

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 thiamethoxam will occupy 9.5% of the aPAD for all infants (<1 year),
the population group receiving the greatest exposure. Acute dietary
exposure from food and water to clothianidin is estimated to occupy 23%
of the aPAD for children 1 to 2 years old, the population group
receiving the greatest exposure.
    2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that chronic exposure to
thiamethoxam from food and water will utilize 43% of the cPAD for
children 1 to 2 years old, the population group receiving the greatest
exposure. Chronic exposure to clothianidin from food and water will
utilize 19% of the cPAD for children 1 to 2 years old, the population
group receiving the greatest exposure.
    Based on the explanation in Unit III.C.3., regarding residential
use patterns, chronic residential exposure to residues of thiamethoxam
and clothianidin is not expected.
    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).
    Thiamethoxam 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 thiamethoxam. Using the
exposure assumptions described in this unit for short-term exposures,
EPA has concluded the combined short-term food, water, and residential
exposures for thiamethoxam result in aggregate MOEs of: 370 for the
general U.S. population; 490 for all infants (<1 year); 440 for
children 1 to 2 years; 450 for children 3-5 years; 370 for children 6-
12 years; 380 for youth 13-19 years, adults 20-49 years, adults 50+
years, and females 13-49 years. Because EPA's level of concern for
thiamethoxam is a MOE of 100 or below, these MOEs are not of concern.
    Using the exposure assumptions described in this unit for short-
term exposures, EPA has concluded the combined short-term food, water,
and residential exposures for clothianidin result in aggregate MOEs of:
1,700 for the general U.S. population; 480 for all infants (<1 year);
380 for children 1 to 2 years; 500 for children 3-5 years; 1,400 for
children 6-12 years; 2,200 for youth 13-19 years, adults 20-49 years,
and females 13-49 years; 2,100 for adults 50+ years. Because EPA's
level of concern for clothianidin is a MOE of 100 or below, these MOEs
are not of concern.
    4. Intermediate-term risk. Intermediate-term aggregate exposure
takes into account intermediate-term residential exposure plus chronic
exposure to food and water (considered to be a background exposure
level).
    Thiamethoxam is currently registered for uses that could result in
intermediate-term residential exposure, and the Agency has determined
that it is appropriate to aggregate chronic exposure through food and
water with intermediate-term residential exposures to thiamethoxam.
    Using the exposure assumptions described in this unit for
intermediate-term exposures, EPA has concluded that the combined
intermediate-term food, water, and residential exposures result in
aggregate MOEs of 370 for the general U.S. population; 540 for all
infants (<1 year); 470 for children 1 to 2 years; 490 for children 3-5
years; 370 for children 6-12 years; 380 for youth 13-19 years, adults
20-49 years, adults 50+ years, and females 13-49 years. Because EPA's
level of concern for thiamethoxam is a MOE of 100 or below, these MOEs
are not of concern.
    Using the exposure assumptions described in this unit for
intermediate exposures, EPA has concluded the combined intermediate
food, water, and residential exposures for clothianidin result in
aggregate MOEs of 1,700 for the general U.S. population; 480 for all
infants (<1 year); 380 for children 1 to 2 years; 500 for children 3-5
years; 1,400 for children 6-12 years; 2,200 for youth 13-19 years,
adults 20-49 years, and females 13-49 years; 2,100 for adults 50+
years. Because EPA's level of concern for clothianidin is a MOE of 100
or below, these MOEs are not of concern.
    5. Aggregate cancer risk for U.S. population. The Agency has
classified thiamethoxam as not likely to be a human carcinogen based on
convincing evidence that a non-genotoxic mode of action for liver
tumors was established in the mouse and that the carcinogenic effects
are a result of a mode of action dependent on sufficient amounts of a
hepatotoxic metabolite produced persistently. Therefore, thiamethoxam
is not expected to pose a cancer risk.
    6. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
to the general population, or to infants and children from aggregate
exposure to thiamethoxam or clothianidin residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (high-performance liquid
chromatography/ultraviolet (HPLC/UV) or mass spectrometry (MS)) is
available to enforce the tolerance expression. The method may be
requested from: Chief, Analytical Chemistry Branch, Environmental
Science Center, 701 Mapes Rd., Ft. Meade, MD 20755-5350; telephone
number:<PHONE_NUMBER>; e-mail address<EMAIL_ADDRESS>    For further details, refer to the document ``Thiamethoxam--Human
Health Risk Assessment for New Seed Treatment Uses on Alfalfa and
Peanuts, and Use in Food Handling Establishments'' in the dockets EPA-
HQ-2010-0041, EPA-HQ-OPP-2010-0324, EPA-HQ-OPP-2010-0602, at http://www.regulations.gov and ``Thiamethoxam. Petition to Establish a
Permanent Tolerance for Residues of the Insecticide Resulting from
Food/Feed Use as a Seed Treatment on Bulb Onions. Response to Data Gaps
from Conditional Registration of Various Food/Feed Crops (as Specified
in HED Memo D281702; M. Doherty; 17 April 2007). Summary of Analytical
Chemistry and Residue Data,'' available in the docket EPA-HQ-OPP-2009-
0737, at http://www.regulations.gov.

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 U.N. 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 thiamethoxam.

C. Response to Comments

    Comments were received in dockets EPA-HQ-OPP-2010-0324 and EPA-HQ-
OPP-2010-0602 from a private citizen who opposes any pesticide that
leaves a residue on food. The Agency has received these same comments
from this commenter on numerous previous occasions and rejects them for
reasons previously stated. 70 FR 1349, 1354 (January 7, 2005).

D. Revisions to Petitioned-For Tolerances

    EPA made two revisions to the tolerances as proposed: The addition
of a tolerance for peanut meal and an increase in the proposed
tolerance for food commodities and feed commodities (other than those
covered by a higher tolerance as a result of use on growing crops) in
food/feed handling establishments.
    In addition to the two requested raw agricultural commodity
tolerances for peanut and peanut hay, EPA considered the residues on
processed peanut commodities. The processed commodities associated with
the proposed use on peanuts are peanut meal and refined oil. Two peanut
field trials were conducted in the U.S. during the 1999 growing season
in which peanut seeds treated at an exaggerated (roughly 6-6.5X) rate
were grown for processing into peanut meal and refined oil.
Thiamethoxam residues were not detected in the nutmeat nor processed
fractions of peanuts grown from peanut seeds treated at the 6-6.5X
rate. Residues were not detected in any of the peanut oil samples upon
processing. Residues were observed in the nutmeat and meal of peanuts,
grown from peanut seeds treated at roughly a 2X rate, from both field
trials. The theoretical concentration factor for peanut meal (EPA
Residue Chemistry Test Guideline 860.1520, Table 3) is 2.2X. The
empirical concentration factors for thiamethoxam in meal (range 2.0-
3.1X, average 2.6X) conform well to the theoretical value. A tolerance
is not required in peanut oil. However, based on the highest average
field trial combined residues of 0.05 ppm (0.09 ppm at a 2X rate) in
peanut nutmeat, and the theoretical concentration factor for peanut
meal of 2.2X, EPA is setting a tolerance of 0.15 ppm in peanut meal.
    The submitted data for thiamethoxam use in food handling areas are
acceptable and support the proposed use (spot, void, and crack and
crevice treatment) in food handling establishments. An adequate variety
of food commodities were exposed to thiamethoxam, in two different
types of food handling establishments, at 1X the maximum proposed rate.
Maximum thiamethoxam and clothianidin residues were each <0.01 ppm in
food commodities exposed to 1X treatment in food handling areas (with
the vast majority of samples containing non-detectable residues). The
registrants proposed tolerance had failed to add these two sources
together. EPA is setting a tolerance of 0.02 ppm in food commodities
and feed commodities (other than those covered by a higher tolerance as
a result of use on growing crops) in food/feed handling establishments
based on the presence of detectable residues of thiamethoxam added to
detectable residues of the metabolite clothianidin in various samples.

 V. Conclusion

    Therefore, tolerances are established for residues of thiamethoxam,
3-[(2-chloro-5-thiazolyl)methyl]tetrahydro-5-methyl-N-nitro-4H-1,3,5-
oxadiazin-4-imine and its metabolite, N-(2-chloro-thiazol-5-ylmethyl)-
N'-methyl-N'-nitro-guanidine, in or on peanut at 0.05 ppm; peanut hay
at 0.25 ppm; peanut meal at 0.15 ppm; alfalfa, forage at 0.05 ppm;
alfalfa, hay at 0.12 ppm; and food commodities and feed commodities
(other than those covered by a higher tolerance as a result of use on
growing crops) in food/feed handling establishments at 0.02 ppm.

VI. Statutory and Executive Order Reviews

    This final rule establishes tolerances under section 408(d) of
FFDCA in response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled Regulatory Planning and
Review (58 FR 51735, October 4, 1993). Because this final rule has been
exempted from review under Executive Order 12866, this final rule is
not subject to Executive Order 13211, entitled Actions Concerning
Regulations That Significantly Affect Energy Supply, Distribution, or
Use (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled
Protection of Children from Environmental Health Risks and Safety Risks
(62 FR 19885, April 23, 1997). This final rule does not contain any
information collections subject to OMB approval under the Paperwork
Reduction Act (PRA), 44 U.S.C. 3501 et seq., nor does it require any
special considerations under Executive Order 12898, entitled Federal
Actions to Address Environmental Justice in Minority Populations and
Low-Income Populations (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis
of a petition under section 408(d) of FFDCA, such as the tolerance in
this final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.) do not apply.
    This final rule directly regulates growers, food processors, food
handlers, and food retailers, not States or tribes, nor does this
action alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of section 408(n)(4) of FFDCA. As such, the Agency has determined that
this action will not have a substantial direct effect on States or
tribal governments, on the relationship between the national government
and the States or tribal governments, or on the distribution of power
and responsibilities among the various levels of government or between
the Federal Government and Indian tribes. Thus, the Agency has
determined that Executive Order 13132, entitled Federalism (64 FR
43255, August 10, 1999) and Executive Order 13175, entitled
Consultation and Coordination with Indian Tribal Governments (65 FR
67249, November 9, 2000) do not apply to this final rule. In addition,
this final rule does not impose any enforceable duty or contain any
unfunded mandate as described under Title II of the Unfunded Mandates
Reform Act of 1995 (UMRA) (Pub. L. 104-4).
    This action does not involve any technical standards that would
require Agency consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272
note).

VII. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report to each House of the Congress and to
the Comptroller General of the United States. EPA will submit a report
containing this rule and

other required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of this final rule in the Federal Register. This final
rule is not a ``major rule'' as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

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

    Dated: August 5, 2011.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

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

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

0
2. Section 180.565 is amended by alphabetically adding the following
commodities to the table in paragraph (a) to read as follows:

Sec.  180.565  Thiamethoxam; tolerances for residues.

    (a) * * *

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
Alfalfa, forage............................................         0.05
Alfalfa, hay...............................................         0.12

                              * * * * * * *
Food commodities and feed commodities (other than those             0.02
 covered by a higher tolerance as a result of use on
 growing crops) in food/feed handling establishments.......

                              * * * * * * *
Peanut.....................................................         0.05
Peanut, hay................................................         0.25
Peanut, meal...............................................         0.15

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

* * * * *

[FR Doc. 2011-20839 Filed 8-16-11; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 78, Number 97 (Monday, May 20, 2013)]
[Notices]
[Page 29398]
[FR Doc No: 2013-11894]

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SECURITIES AND EXCHANGE COMMISSION

Proposed Collection; Comment Request

Upon Written Request Copies Available From: Securities and Exchange
Commission, Office of Investor Education and Advocacy, Washington, DC
20549-0213.

Extension:
    Rule 477. OMB Control No. 3235-0550, SEC File No. 270-493.

    Notice is hereby given that, pursuant to the Paperwork Reduction
Act of 1995 (44 U.S.C. 3501 et seq.), the Securities and Exchange
Commission (``Commission'') is soliciting comments on the collection of
information summarized below. The Commission plans to submit this
existing collection of information to the Office of Management and
Budget for extension and approval.
    Rule 477 (17 CFR 230.477) under the Securities Act of 1933 (15
U.S.C. 77a et seq.) sets forth procedures for withdrawing a
registration statement, including any amendments or exhibits to the
registration statement. The rule provides that if an issuer intends to
rely on the safe harbor contained in Securities Act Rule 155 to conduct
an unregistered private offering of securities, the issuer must
affirmatively state in the withdrawal application that it plans to
undertake a subsequent private offering of its securities. Without this
statement, the Commission would not be able to monitor a company's
reliance on, and compliance with, Securities Act Rule 155(c). We
estimate that approximately 300 issuers will file Securities Act Rule
477 submissions annually at an estimated one hour per response for a
total annual burden of approximately 300 hours.
    Written comments are invited on: (a) Whether this proposed
collection of information is necessary for the proper performance of
the functions of the agency, including whether the information will
have practical utility; (b) the accuracy of the agency's estimate of
the burden imposed by the collection of information; (c) ways to
enhance the quality, utility, and clarity of the information collected;
and (d) ways to minimize the burden of the collection of information on
respondents, including through the use of automated collection
techniques or other forms of information technology. Consideration will
be given to comments and suggestions submitted in writing within 60
days of this publication.
    An agency may not conduct or sponsor, and a person is not required
to respond to, a collection of information unless it displays a
currently valid control number.
    Please direct your written comments to Thomas Bayer, Director/Chief
Information Officer, Securities and Exchange Commission, c/o Remi
Pavlik-Simon, 6432 General Green Way, Alexandria, VA 22312; or send an
email to<EMAIL_ADDRESS>
    Dated: May 14, 2013.
Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2013-11894 Filed 5-17-13; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register: November 28, 2007 (Volume 72, Number 228)]
[Notices]
[Page 67290-67291]
[DOCID:fr28no07-35]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket Nos. ER07-1317-000, ER07-1317-001, ER07-1318-000, ER07-1318-
001]

Citizens Electric Company of Lewisburg, PA, Wellsboro Electric
Company; Notice of Issuance of Order

November 20, 2007.
    Citizens Electric Company of Lewisburg, PA (Citizens) and Wellsboro
Electric Company (Wellsboro) filed an application for market-based rate
authority, with an accompanying rate tariff. The proposed market-based
rate tariff provides for the sale of energy and capacity at market-
based rates. Citizens and Wellsboro also requested waivers of various
Commission regulations. In particular, Citizens and Wellsboro requested
that the Commission grant blanket approval under 18 CFR part 34 of all
future issuances of securities and assumptions of liability by Citizens
and Wellsboro.

    On November 16, 2007, pursuant to delegated authority, the
Director, Division of Tariffs and Market Development--West, granted the
requests for blanket approval under part 34 (Director's Order). The
Director's Order also stated that the Commission would publish a
separate notice in the Federal Register establishing a period of time
for the filing of protests. Accordingly, any person desiring to be
heard concerning the blanket approvals of issuances of securities or
assumptions of liability by Citizens and Wellsboro, should file a
protest with the Federal Energy Regulatory Commission, 888 First
Street, NE., Washington, DC 20426, in accordance with Rules 211 and 214
of the Commission's Rules of Practice and Procedure. 18 CFR 385.211,
385.214 (2004).
    Notice is hereby given that the deadline for filing protests is
December 17, 2007.
    Absent a request to be heard in opposition to such blanket
approvals by the deadline above, Citizens and Wellsboro are authorized
to issue securities and assume obligations or liabilities as a
guarantor, indorser, surety, or otherwise in respect of any security of
another person; provided that such issuance or assumption is for some
lawful object within the corporate purposes of Citizens and Wellsboro,
compatible with the public interest, and is reasonably necessary or
appropriate for such purposes.
    The Commission reserves the right to require a further showing that
neither public nor private interests will be adversely affected by
continued approvals of Citizen's and Wellsboro's issuance of securities
or assumptions of liability.
    Copies of the full text of the Director's Order are available from
the Commission's Public Reference Room, 888 First Street, NE.,
Washington, DC 20426. The Order may also be viewed on the Commission's
Web site at http://www.ferc.gov, using the eLibrary link. Enter the
docket number excluding the last three digits in the docket number
filed to access the document. Comments, protests, and interventions may
be filed electronically via the internet in lieu of paper. See, 18 CFR
385.2001(a)(1)(iii) and the instructions on the Commission's Web site
under the ``e-Filing'' link. The Commission strongly encourages
electronic filings.

Kimberly D. Bose,
Secretary.
 [FR Doc. E7-23069 Filed 11-27-07; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 83, Number 188 (Thursday, September 27, 2018)]
[Notices]
[Page 48841]
[FR Doc No: 2018-21028]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-3404-EM; Docket ID FEMA-2018-0001]

Hawaii; Emergency and Related Determinations

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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SUMMARY: This is a notice of the Presidential declaration of an
emergency for the State of Hawaii (FEMA-3404-EM), dated September 12,
2018, and related determinations.

DATES: The declaration was issued September 12, 2018.

FOR FURTHER INFORMATION CONTACT: Dean Webster, Office of Response and
Recovery, Federal Emergency Management Agency, 500 C Street SW,
Washington, DC 20472,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: Notice is hereby given that, in a letter
dated September 12, 2018, the President issued an emergency declaration
under the authority of the Robert T. Stafford Disaster Relief and
Emergency Assistance Act, 42 U.S.C. 5121-5207 (the Stafford Act), as
follows:

    I have determined that the emergency conditions in certain areas
of the State of Hawaii resulting from Tropical Storm Olivia
beginning on September 9, 2018, and continuing, are of sufficient
severity and magnitude to warrant an emergency declaration under the
Robert T. Stafford Disaster Relief and Emergency Assistance Act, 42
U.S.C. 5121 et seq. (``the Stafford Act''). Therefore, I declare
that such an emergency exists in the State of Hawaii.
    You are authorized to provide appropriate assistance for
required emergency measures, authorized under Title V of the
Stafford Act, to save lives and to protect property and public
health and safety, and to lessen or avert the threat of a
catastrophe in the designated areas. Specifically, you are
authorized to provide assistance for emergency protective measures
(Category B), limited to direct Federal assistance, under the Public
Assistance program.
    Consistent with the requirement that Federal assistance be
supplemental, any Federal funds provided under the Stafford Act for
Public Assistance will be limited to 75 percent of the total
eligible costs. In order to provide Federal assistance, you are
hereby authorized to allocate from funds available for these
purposes such amounts as you find necessary for Federal emergency
assistance and administrative expenses.
    Further, you are authorized to make changes to this declaration
for the approved assistance to the extent allowable under the
Stafford Act.

    The Federal Emergency Management Agency (FEMA) hereby gives notice
that pursuant to the authority vested in the Administrator, Department
of Homeland Security, under Executive Order 12148, as amended, Dolph A.
Diemont, of FEMA is appointed to act as the Federal Coordinating
Officer for this declared emergency.
    The following areas of the State of Hawaii have been designated as
adversely affected by this declared emergency:

    Hawaii, Maui, and Kauai Counties and the City and County of
Honolulu for emergency protective measures (Category B), limited to
direct Federal assistance, under the Public Assistance program.

    The following Catalog of Federal Domestic Assistance Numbers
(CFDA) are to be used for reporting and drawing funds: 97.030,
Community Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis
Counseling; 97.033, Disaster Legal Services; 97.034, Disaster
Unemployment Assistance (DUA); 97.046, Fire Management Assistance
Grant; 97.048, Disaster Housing Assistance to Individuals and
Households In Presidentially Declared Disaster Areas; 97.049,
Presidentially Declared Disaster Assistance--Disaster Housing
Operations for Individuals and Households; 97.050, Presidentially
Declared Disaster Assistance to Individuals and Households--Other
Needs; 97.036, Disaster Grants--Public Assistance (Presidentially
Declared Disasters); 97.039, Hazard Mitigation Grant.

Brock Long,
Administrator, Federal Emergency Management Agency.
[FR Doc. 2018-21028 Filed 9-26-18; 8:45 am]
BILLING CODE 9111-11-P