[Federal Register Volume 78, Number 226 (Friday, November 22, 2013)]
[Notices]
[Pages 70085-70087]
[FR Doc No: 2013-28026]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-70894; File No. SR-CHX-2013-19]

Self-Regulatory Organizations; Chicago Stock Exchange, Inc.;
Notice of Filing and Immediate Effectiveness of Proposed Rule Change To
Correct Certain Rule Taxonomy Issues and Postpone Until December 2,
2013 the Operative Date of an Approved Proposed Rule Change

November 18, 2013.
    Pursuant to Section 19(b)(1) \1\ of the Securities Exchange Act of
1934 (the ``Act'') \2\ and Rule 19b-4 thereunder,\3\ notice is hereby
given that, on November 12, 2013, Chicago Stock Exchange, Inc. (the
``Exchange'' or ``CHX'') filed with the Securities and Exchange
Commission (the ``Commission'') the proposed rule change as described
in Items I and II below, which Items have been prepared by the self-
regulatory organization. The Commission is publishing this notice to
solicit comments on the proposed rule change from interested persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 15 U.S.C. 78a.
    \3\ 17 CFR 240.19b-4.
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    CHX proposes to amend Article 1, Rule 1 (Definitions); Article 20,
Rule 9 (Cancellation or Adjustment of Bona Fide Error Trades); Article
20, Rule 9A (Error Correction Transactions); and Article 20, Rule 11
(Cancellation or Adjustment of Stock Leg Trades) to correct certain
taxonomy issues and to adopt an operative date of December 2, 2013 for
all changes that were approved by the Securities and Exchange
Commission (the ``SEC'' or the ``Commission'') under 34-70791.
    The text of this proposed rule change is available on the
Exchange's Web site at (www.chx.com) and in the Commission's Public
Reference Room.

II. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

    In its filing with the Commission, the CHX included statements
concerning the purpose of and basis for the proposed rule changes and
discussed any comments it received on the proposed rule change. The
text of these statements may be examined at the places specified in
Item IV below. The CHX has prepared summaries, set forth in sections A,
B and C below, of the most significant aspects of such statements.

A. Self-Regulatory Organization's Statement of the Purpose of, and the
Statutory Basis for, the Proposed Rule Change

1. Purpose
    The Exchange proposes to amend Article 1, Rule 1 (Definitions);
Article 20, Rule 9 (Cancellation or Adjustment of Bona Fide Error
Trades); Article 20, Rule 9A (Error Correction Transactions); and
Article 20, Rule 11 (Cancellation or Adjustment of Stock Leg Trades) to
correct certain taxonomy issues and to adopt an operative date of
December 2, 2013 for all changes that were approved by the Commission
under 34-70791.\4\ Aside from these proposed amendments, the Exchange
does not propose any other changes to the definitions or text approved
under 34-70791.
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    \4\ See Securities Exchange Act Release No. 70791 (October 31,
2013), 78 FR 66791 (November 6, 2013) (Order Approving a Proposed
Rule Change to Adopt Standards for the Cancellation or Adjustment of
Bona Fide Error Trades, the Submission of Error Correction
Transactions, and the Cancellation or Adjustment of Stock Leg Trades
of Stock-Option or Stock-Future Orders).
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Background
    On September 4, 2013, the Exchange filed with the Commission,
pursuant to Section 19(b)(1) of the Act \5\ and Rule 19b-4
thereunder,\6\ a proposed rule change to amend CHX Article 20, Rule 9
to outline and clarify the Exchange's current requirements for the
cancellation of trades based on Bona Fide Error; to adopt CHX Article
20, Rule 9A to detail the Exchange's current requirements for Error
Correction Transactions; and to adopt CHX Article 20, Rule 11 to amend
the Exchange's current requirements for the cancellation of the stock
leg trade of a Stock-Option order, to establish new requirements for
the adjustment of the stock leg trade of a Stock-Option order, and to
allow the stock leg trade of Stock-Future orders to be cancelled or
adjusted.\7\ The proposed rule change was published for comment in the
Federal Register on September 18, 2013.\8\ The Commission received no
comments on the proposal. The

Commission approved the proposed rule change on October 31, 2013.\9\
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    \5\ 15 U.S.C. 78s(b)(1).
    \6\ 17 CFR 240.19b-4.
    \7\ The Exchange notes that SR-CHX-2013-16 does not explicitly
provide an operative date for the proposed amendments to CHX rules.
    \8\ See Securities Exchange Act Release No. 70381 (September 12,
2013), 78 FR 57431 (September 18, 2013) (SR-CHX-2013-16)
(``Notice'').
    \9\ See supra note 4.
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Taxonomy Amendments
    After SR-CHX-2013-16 was filed on September 4, 2013, the Exchange
filed SR-CHX-2013-14 on September 24, 2013,\10\ which, among other
things, adopted Article 1, Rule 1(hh) to define the term ``Customer''
as ``any person or entity other than a broker or dealer registered with
the Commission.'' However, since the Exchange had already proposed to
adopt Article 1, Rule 1(hh) to define ``Bona Fide Error'' pursuant to
SR-CHX-2013-16, when the Commission approved SR-CHX-2013-16 on October
31, 2013, Article 1, Rule 1(hh) now provided definitions for both
``Customer'' and ``Bona Fide Error.''
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    \10\ See Securities Exchange Act Release No. 70597 (October 2,
2013), 78 FR 62728 (October 22, 2013) (SR-CHX-2013-14) (``Notice of
Filing and Immediate Effectiveness of Proposed Rule Change Relating
to Registration, Qualification, Supervision, and Continuing
Education of Individuals Associated with Participant Firms'').
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    Thus, the Exchange now proposes to move the definition of ``Bona
Fide Error'' from current Article 1, Rule 1(hh) to proposed Article 1,
Rule 1(ii). Correspondingly, the Exchange proposes to amend Article 20,
Rule 9(a), Rule 9(b)(2), and Rule 9A(a)(1) to reflect that ``Bona Fide
Error'' is defined under proposed Article 1, Rule 1(ii).
    Consequently, the Exchange proposes to move the definition of
``Stock-Option'' from current Article 1, Rule 1(ii) to proposed Article
1, Rule 1(jj) and the definition of ``Stock-Future'' from current
Article 1, Rule 1(jj) to proposed Article 1, Rule 1(kk).
Correspondingly, the Exchange proposes to amend Article 20, Rule 11(a)
to reflect that ``Stock-Option'' is defined under proposed Article 1,
Rule 1(jj) and ``Stock-Future'' is defined under proposed Article 1,
Rule 1(kk).
Proposed Operative Date
    The Exchange proposes to suspend the operative date for all rule
changes that were approved under 34-70791 to December 2, 2013.\11\ The
Exchange submits that the proposed December 2, 2013 operative date is
reasonable in light of the significant changes that were approved under
34-70791.
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    \11\ See supra note 4.
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    As such, the Exchange now proposes to adopt language that provides
that certain CHX rules shall be operative as of December 2, 2013.
Specifically, directly above proposed Article 1, Rule 1(ii), the
Exchange proposes to insert language that provides that paragraphs
(ii)-(kk) shall be operative as of December 2, 2013. Also, directly
above current Article 20, Rule 9(a), the Exchange proposes to insert
language that provides that current Rule 9 shall be operative as of
December 2, 2013. In addition, directly above current Article 20, Rule
9A(a), the Exchange proposes to insert language that provides that
current Rule 9A shall be operative as of December 2, 2013. Moreover,
directly above current Article 20, Rule 11(a), the Exchange proposes to
adopt language that provides that current Rule 11 shall be operative as
of December 2, 2013.
    Moreover, since the changes approved under 34-70791 resulted in the
previous version of Article 20, Rule 9 being superseded by current
Article 20, Rule 9, the Exchange proposes to reincorporate the previous
version of Article 20, Rule 9 verbatim as a separate rule from current
Article 20, Rule 9, while inserting language to it stating that the
previous version of Article 20, Rule 9 shall be operative through
December 1, 2013. The Exchange submits that this sunset provision is
necessary to avoid confusion to our Participants and to facilitate a
smooth transition into the approved rules.
2. Statutory Basis
    The Exchange believes that the proposed rule change is consistent
with the requirements of the Act and the rules and regulations
thereunder that are applicable to a national securities exchange, and,
in particular, with the requirements of Section 6(b) of the Act.\12\
Specifically, the proposal is consistent with Section 6(b)(5) of the
Act,\13\ which requires exchange rules to promote just and equitable
principles of trade, remove impediments to, and perfect the mechanism
of, a free and open market and a national market system, and, in
general, protect investors and the public interest. The proposal is
also consistent with Section 6(b)(1) of the Act,\14\ which requires
that an exchange be so organized and has the capacity to be able to
carry out the purposes of 15 U.S.C. 78a et seq. and to comply, and to
enforce compliance by its members and persons associated with its
members, with the provisions of 15 U.S.C. 78a et seq., the rules and
regulations thereunder, and the rules of the exchange.
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    \12\ 15 U.S.C. 78f(b).
    \13\ 15 U.S.C. 78f(b)(5)
    \14\ 15 U.S.C. 78f(b)(1)
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    The Exchange believes that the proposed taxonomy corrections
fulfill these requirements because it promotes clarity of CHX rules by
ensuring that there is only one definition per citation. Similarly, the
reinsertion of previous version of Article 20, Rule 9 also fulfills
these requirements because it promotes clarity of CHX rules by
providing that the previous version of Rule 9 shall be in the effect
through December 1, 2013. Moreover, the proposed operative date of
December 2, 2013 for all rule changes approved under 34-70791 fulfill
these requirements and, in particular, Section 6(b)(1), because the
December 2, 2013 operative date will facilitate the proper
implementation of complex functionalities, which will, in turn, allow
the Exchange to better enforce compliance by its Participants of the
rules approved under 34-70791.

B. Self-Regulatory Organization's Statement on Burden on Competition

    The Exchange believes the proposal is consistent with Section
6(b)(8) of the Act \15\ in that it does not impose any burden on
competition that is not necessary or appropriate in furtherance of the
purposes of the Act. The proposed rule changes correct non-substantive
taxonomy issues and set an operative date for functionality that has
already been approved by the Commission.\16\ Accordingly, the Exchange
does not believe that the proposed rule change will have any effect on
competition.
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    \15\ 15 U.S.C. 78(f)(b)(8).
    \16\ See supra note 4.
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C. Self-Regulatory Organization's Statement on Comments on the Proposed
Rule Change Received From Members, Participants, or Others

    No written comments were either solicited or received.

III. Date of Effectiveness of the Proposed Rule Change and Timing for
Commission Action

    The Exchange has filed the proposed rule change pursuant to Section
19(b)(3)(A)(iii) of the Act \17\ and Rule 19b-4(f)(6) thereunder.\18\
Because the proposed rule change does not: (i) Significantly affect the
protection of investors or the public interest; (ii) impose any
significant burden on competition; and (iii) become operative prior to
30 days from the date on which it was filed, or such shorter time as
the Commission may designate, if consistent with the protection of
investors and the public interest, the proposed rule change has become
effective pursuant to Section 19(b)(3)(A) of the Act and Rule 19b-
4(f)(6)(iii) thereunder.
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    \17\ 15 U.S.C. 78s(b)(3)(A)(iii).
    \18\ 17 CFR 240.19b-4(f)(6).

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    A proposed rule change filed under Rule 19b-4(f)(6) \19\ normally
does not become operative prior to 30 days after the date of the
filing. However, pursuant to Rule 19b- 4(f)(6)(iii),\20\ the Commission
may designate a shorter time if such action is consistent with the
protection of investors and the public interest. The Exchange has asked
the Commission to waive the 30-day operative delay so that the proposal
may become operative immediately upon filing.
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    \19\ 17 CFR 240.19b-4(f)(6).
    \20\ 17 CFR 240.19b-4(f)(6)(iii). In addition, Rule 19b-
4(f)(6)(iii) requires the Exchange to provide the Commission with
written notice of its intent to file the proposed rule change, along
with a brief description and text of the proposed rule change, at
least five business days prior to the date of filing of the proposed
rule change, or such shorter time as designated by the Commission.
The Exchange has satisfied this requirement.
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    The Commission believes that waiving the 30-day operative delay is
consistent with the protection of investors and the public interest.
The proposed taxonomy changes and non-substantive and should make the
Exchange's rules easier to understand. The Exchange states that a
temporary delay in the operation of SR-CHX-2013-16 will facilitate the
proper implementation of complex functionalities, which in turn will
allow it to better enforce compliance with the approved rules. Based on
that representation, the Commission believes that delayed
implementation is consistent with the protection of investors and the
public interest. For these reasons, the Commission hereby waives the
30-day operative delay and designates the proposal operative upon
filing.\21\
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    \21\ For purposes only of waiving the 30-day operative delay,
the Commission has considered the proposed rule's impact on
efficiency, competition, and capital formation. See 15 U.S.C.
78c(f).
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    At any time within 60 days of the filing of such proposed rule
change, the Commission summarily may temporarily suspend such rule
change if it appears to the Commission that such action is necessary or
appropriate in the public interest, for the protection of investors, or
otherwise in furtherance of the purposes of the Act. If the Commission
takes such action, the Commission shall institute proceedings under
Section 19(b)(2)(B) \22\ of the Act to determine whether the proposed
rule change should be approved or disapproved.
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    \22\ 15 U.S.C. 78s(b)(2)(B).
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IV. Solicitation of Comments

    Interested persons are invited to submit written data, views, and
arguments concerning the foregoing, including whether the proposed rule
change is consistent with the Act. Comments may be submitted by any of
the following methods:

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to<EMAIL_ADDRESS>Please include
File No. SR-CHX-2013-19 on the subject line.

Paper Comments

     Send paper comments in triplicate to Elizabeth M. Murphy,
Secretary, Securities and Exchange Commission, 100 F Street NE.,
Washington, DC 20549-1090.

All submissions should refer to File No. SR-CHX-2013-19. This file
number should be included on the subject line if email is used. To help
the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Web site (http://www.sec.gov/rules/sro.shtml). Copies
of the submission, all subsequent amendments, all written statements
with respect to the proposed rule change that are filed with the
Commission, and all written communications relating to the proposed
rule change between the Commission and any person, other than those
that may be withheld from the public in accordance with the provisions
of 5 U.S.C. 552, will be available for Web site viewing and printing in
the Commission's Public Reference Room, 100 F Street NE., Washington,
DC 20549, on official business days between the hours of 10:00 a.m. and
3:00 p.m. Copies of such filing also will be available for inspection
and copying at the principal office of the Exchange. All comments
received will be posted without change; the Commission does not edit
personal identifying information from submissions. You should submit
only information that you wish to make available publicly. All
submissions should refer to File No. SR-CHX-2013-19 and should be
submitted on or before December 13, 2013.
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    \23\ 17 CFR 200.30-3(a)(12).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\23\
Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2013-28026 Filed 11-21-13; 8:45 am]
BILLING CODE 8011-01-P


Compliance Program Fees Briefing for OMB EPA Office of Air and Radiation Office of Transportation and Air Quality February 26, 2004 Slide  2 Briefing Summary   Review existing fee program   Review need to revise regulations   Features of fees rulemaking   Changes since proposal   Fees impact   Schedule Slide  3 Fee Program Review   Independent Offices Appropriations Act

IOAA 1982   Clean Air Act 1990   OMB Circular A 25   Fees final rule 1992   Fees modification with CAP 2000 in 1999   Fees modification in 2000 for alt. fueled vehicles   Collected $ 115 million to date  $ 11 million annually   Will collect $ 18 m annually Slide  4 Need to Revise Fees Regulation   Light duty changes since 1992  New compliance programs   Heavy duty in use program   Several new non road compliance programs   Large  diesel ( earthmovers, generators, tractors, etc.)

  Large  gas ( forklifts, air ground service equipment,

compressors)

  Utility engines handheld ( chainsaws, weed whackers,

leafblowers

  Utility engines non handheld ( lawnmowers, generators, garden tractors, tillers)

  Marine  ( boat motors, tugs, watercraft, jet skis)

  Locomotive   Recreational vehicles ( off road motorcycles, snowmobiles) Slide  5 Need to Revise Fees Regulation  continued   Laboratory upgrades for new requirements   MY2004  Tier 2   MY2004 & 2007  diesel stds   Laboratory upgrades necessary to ensure compliance with existing requirements   Increased or new testing capability for HD & NR at NVFEL   Fee equity between onroad and nonroad   Nonroad Slide  6 Features in Rulemaking   Fee Equity   All regulated industries now pay fees   Updated labor costs   Fees adjust for fluctuation in CPI and in number of certificates   Extended alt fuel converter waiver provisions Slide  7 Changes since NPRM   HD HW and NR Diesel fees decreased   Amount of in use testing reevaluated   Test cell costs prorated   Number of certificates issued recalculated   Annual fees adjustment for CPI   Annual adjustment for number of certs   Implementation schedule   Reduced Fee provision   No fees for marine SI inboard/ sterndrive Slide  8 EPA Revised Costs by Category   Fee category current: proposed: average sales:

cost (# units)

final: per unit:

  Light duty & fuel economy $ 9.7 m $ 13.4 m 13.4 m $ 0.85 15.0m   Heavy duty highway CI& SI $ 1.7 m $ 4.0 m 3.2 m $ 1.98 1.6m   Motorcycles $ 0.2 m $ 0.5 m 0.5 m $ 1.21 0.4m   Nonroad CI $ 0 $ 1.3 m 1.2 m $ 1.37 0.9m   Nonroad SI $ 0 $ 0.5 m 0.5 m $ 0.02 29.7m   Locomotives $ 0 $ 0.01m 0.01m $ 8.49 1k   Others* $ $ 0.4 0.4m   Total fees: $ 11.6m $ 20.1m $ 19.2m   Estimated Waivers: $ 1.5m $ 1.0 m $ 1.0m   Anticipated Net Collections** $ 10.1m $ 19.1 m $ 18.2m   * Includes marine engines, recreational, California only HD HW engines   * * These numbers can vary by plus or minus $ 1m as manufacturers consolidate or expand the number of engine families Slide  9 Proposed Fees ( per certificate)

Version LD LD Cal only ICI MC HDHW NR CI All Other NR HD HW Cal only HD HW Evap Current Fees $ 27,211 $ 8,956 $ 27,211 $ 840 $ 12,584 $ 0 $ 0 $ 12,584 $ 2,045 Published in NPRM August 2002 $ 33,911 $ 16,958 $ 8,394 $ 2,416 $ 30,437 $ 2,156 $ 827 $ 827 $ 827 Final Fees $ 33,883 $ 16,944 $ 8,387 $ 2,414 $ 21,578 $ 1,822 $ 826 $ 826 $ 826 Slide  10 Schedule   Need to expedite rule   New fees to be collected 60 days after publication Slide  11 EPA Contacts   Lynn Sohacki, Fees Team Leader ( 734) 214 4851   Dan Harrison, CCD Group Manager ( 734) 214 4281   Lori Stewart, CCD Deputy Director ( 202) 343 9070   Winifred Okoye, Office of General Counsel ( 202) 564 5446


[Federal Register Volume 86, Number 183 (Friday, September 24, 2021)]
[Notices]
[Page 53102]
[FR Doc No: 2021-20698]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-4524-DR; Docket ID FEMA-2021-0001]

Arizona; Amendment No. 6 to Notice of a Major Disaster
Declaration

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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SUMMARY: This notice amends the notice of a major disaster declaration
for the State of Arizona (FEMA-4524-DR), dated April 4, 2020, and
related determinations.

DATES: This amendment was issued August 5, 2021.

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: The notice of a major disaster declaration
dated April 4, 2020 for the State of Arizona is hereby amended to
include the Hazard Mitigation Grant Program.

    All areas within the State of Arizona are eligible for
assistance under the Hazard Mitigation Grant 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.

Deanne Criswell,
Administrator, Federal Emergency Management Agency.
[FR Doc. 2021-20698 Filed 9-23-21; 8:45 am]
BILLING CODE 9111-23-P


  MacroButton macIb01 i

EPA REGISTRATION DIVISION COMPANY NOTICE OF FILING FOR PESTICIDE
PETITIONS PUBLISHED IN THE FEDERAL REGISTER

EPA Registration Division contact: [Rosanna Louie-Juzwiak, (703)
308-0037]

INSTRUCTIONS:  Please utilize this outline in preparing the pesticide
petition.  In cases where the outline element does not apply, please
insert “NA-Remove” and maintain the outline. Please do not change
the margins, font, or format in your pesticide petition. Simply replace
the instructions that appear in green, i.e., “[insert company
name],” with the information specific to your action.

TEMPLATE:

[Nichino America, Inc.]

[PP #0F7791]

	EPA has received a pesticide petition [#0F7791] from [Nichino America,
Inc], [4550 New Linden Hill Rd., Suite 501, Wilmington, DE 19808]
proposing, pursuant to section 408(d) of the Federal Food, Drug, and
Cosmetic Act (FFDCA), 21 U.S.C. 346a(d), to amend 40 CFR part 180.

(Options (pick one)

	1. by establishing a tolerance for residues of

	[Tolfenpyrad (4-chloro-3-ethyl-1 –methyl-N-[4-(p-tolyloxy) benzyl]
pyrazole-

5-carboxamide )] in or on the following raw agricultural commodities:
[head lettuce at 5 ppm, leaf lettuce at 30 ppm, celery subgroup 4B, leaf
petioles at 12.5 ppm, spinach at 24 ppm, brassica head and stem crop
group 5A at 3.6 ppm, brassica leafy group 5B at 44 ppm, fruiting
vegetables crop group 8 at 0.6 ppm, potatoes at 0.04 ppm, tree nut crop
group 14 at 0.04 ppm, pistachio at 0.04 ppm, pome fruit group at 0.6
ppm, cucurbit crop group 9 at 0.8 ppm, stone fruit group 12 at 3.0 ppm,
prunes at 3 ppm, pomegranates at 3.0 ppm, persimmons at 3.0 ppm, citrus
crop group at 1.0 ppm, citrus pulp dried at 2.0 ppm, citrus oil at 16.0
ppm, grapes at 2.0 ppm, raisins at 5 ppm, apple pomace, wet, at 5.0 ppm,
cottonseed, undelinted, at 0.6 ppm, tea at 20 ppm, milk at 0.03 ppm,
fat, cattle, goat, horse, sheep at 0.01 ppm, kidney, cattle, goat,
horse, sheep at 0.3 ppm, liver, cattle, goat, horse, sheep at 0.7 ppm,
meat, cattle, goat, horse, sheep at 0.02 ppm, almond hulls at 5.0 ppm,
and cotton gin trash at 9.0 ppm.]  EPA has determined that the petition
contains data or information regarding the elements set forth in section
408 (d)(2) of  FDDCA; however, EPA has not fully evaluated the
sufficiency of the submitted data at this time or whether the data
supports granting of the petition. Additional data may be needed before
EPA rules on the petition.

A. Residue Chemistry

	1. Plant metabolism. [Nature of the Residue studies have been conducted
with tolfenpyrad labeled in both the Tolyl and Pyrazole rings in four
different crop groups (fruits - peach, fruiting vegetable - eggplant,
leafy vegetables - cabbage and root and tuber vegetables - radish).  In
all these studies unmetabolized tolfenpyrad remained as the major
residue comprising 40% to 80% of the TRR. Metabolism of tolfenpyrad in
plants is similar to animals showing the classic oxidative pathway
common to both.  When metabolism occurs, it is through systemic
oxidative hydroxylation of the exposed methyl groups followed by
conversion to the water soluble acid or by simple cleavage to the
pyrazole carboxylic acid.  Individual metabolites were detected only at
low levels and there was no evidence of accumulation of any specific
analyte.]

	2. Analytical method. [An analytical method was developed for
determination of Tolfenpyrad residues in crops.  This method involves
extraction of Tolfenpyrad residues from crop samples with methanol, then
extracts are vacuum filtered, for all matrices, except processed oils,
then combined with water prior to being cleaned-up using polymeric
solid-phase extraction cartridges. The purified extract was evaporated
to dryness and reconstituted in methanol.  Residues of tolfenpyrad are
quantified using high performance liquid chromatography with tandem mass
spectrometric detection (LC-MS/MS).  The limit of quantitation is 0.01
ppm for tolfenpyrad.  This method has been successfully validated at an
independent facility and therefore is suitable for use as the
enforcement method for the determination of residues of tolfenpyrad in
crops.]

	3. Magnitude of residues. [The magnitude of the residue studies are
submitted with this petition for apple, pear, cucumber, squash,
tomatoes, peppers, potato, head and leaf lettuce, mustard greens,
oranges, grapefruit, lemon, grapes, cotton, cauliflower, cabbage,
almonds, pecans, cherry, peach, and plum.  All studies meet EPA Test
Guidelines 860.1000, 860.1500, and 860.1520.  Residues detected are
below the tolerance proposed for the crop group or individual crop.
Residues between 0.01 and 9.0 ppm were detected in certain animal feed
commodities.]

B. Toxicological Profile

1. Acute toxicity.  [Tolfenpyrad Technical is acutely toxic with a
classification of Category II for acute oral toxicity and is a less
toxic Category III for acute dermal, inhalation, and eye irritation.
Tolfenpyrad is a Category IV for skin irritation, and is not a skin
sensitizer.]

	2. Genotoxicty. [Tolfenpyrad was non-mutagenic (negative) in: in vitro
bacterial mutation, in vitro mammalian cell gene mutation (mouse
lymphoma), in vitro cytogenetics in Chinese Hamster Lung (CHL) cells and
an in vivo mouse micronucleus (cytogenetics) assay.  A weight of
evidence evaluation demonstrates that tolfenpyrad is not genotoxic in
mammalian systems.]

	3. Reproductive and developmental toxicity.  [Neither developmental nor
reproductive endpoints were of concern.  No developmental toxicity was
observed in the rat and rabbit below maternally toxic doses.  In the rat
the maternal NOAEL was 1 mg/kg/day and the developmental NOAEL was 3
mg/kg/day.  In the rabbit, the maternal NOAEL was 6 mg/kg/day and the
developmental NOAEL was 6 mg/kg/day.  In the 2-generation reproduction
study in rats, tolfenpyrad was tested at 0.75, 1.5, and 3.0 mg/kg/day.
The parental NOAEL was 1.5 mg/kg, based on decreased body weight, body
weight gains, and decreased motor activity.  The NOAEL for offspring was
1.5 mg/kg, based on decreased pup viability and pup weights.  No
reproduction effects of concern were observed below maternally toxic
levels.]

	4. Neurotoxicity.  [In an acute neurotoxicity study Tolfenpyrad in corn
oil was administered once via gavage (5 mL/kg) to 10 Sprague-Dawley
rats/group at dose levels of 0, 20, 40, or 60 mg/kg in males and 0, 10,
20, or 40 mg/kg in females, and the animals were observed for up to 14
days post-dosing.  The neurotoxicity LOAEL was not observed. The
neurotoxicity NOAEL is 60 mg/kg in males and 40 mg/kg in females.  In a
subchronic neurotoxicity study Tolfenpyrad was administered in the diet
to 10 Sprague-Dawley rats/sex/group at dose levels of 0, 15, 40, or 80
ppm (equivalent to 0/0, 1.0/1.2, 2.7/3.2, and 5.4/6.0 mg/kg/day [M/F],
respectively) for 13 weeks. The neurotoxicity LOAEL was not observed.
The neurotoxicity NOAEL is 80 ppm (equivalent to 5.4/6.0 mg/kg/day,
M/F).  Tolfenpyrad is not neurotoxic.]

	5. Subchronic toxicity. [In a subchronic oral toxicity study
Tolfenpyrad was administered in the diet to Fischer 344 rats
(10/sex/dose) at doses of 0, 15, 80, or 160 ppm (equivalent to 0/0,
0.9/1.0, 4.8/5.2, and 9.3/9.3 mg/kg/day for males/females) for 13 weeks.
Additionally 6 rats/sex were similarly treated for 13 weeks at 0 or 160
ppm and then subsequently allowed 4 weeks of control diet (recovery
period).  The NOAEL was 15 ppm (0.9/1.0 mg/kg/day in males/females)
based on based on decreased body weights, body weight gains, and food
consumption in both sexes.  Additionally, increased relative liver and
kidney weights, hepatocellular hypertrophy, brown color change in the
liver; hyaline droplets in the kidney; brown color change in the
Harderian gland along with hypersecretion at 80 ppm.  A sub-chronic
capsule study in dogs conducted for thirteen weeks had a NOAEL of 10
mg/kg/day in male/females, based on effects observed at 30 mg/kg/day of
mortality, decreased body weights and body weight gains and food
consumption with effects noted in the liver, testes and kidney.  In a
rat 21-day dermal study, the NOAEL is 200 mg/kg/day, the highest dose
tested.  In a rat 28-day inhalation study, the NOAEL was 10 mg/m3
calculated to be 2.6 mg/kg/day, the highest dose tested.]

	6. Chronic toxicity. [In a chronic oral toxicity study Tolfenpyrad was
administered to four beagle dogs/sex/dose group daily by capsule at
doses of 0, 1, 5 or 20 mg/kg/day for at least 12 months. However, the
high dose was reduced to 10 mg/kg/day on Week 5 for the remainder of the
study because of excessive toxicity.  The LOAEL was 10 mg/kg/day, based
on mortality, vomiting, decreased body weights, body weight gains, food
consumption, increased serum alanine aminotransferase in the males, and
microscopic liver findings in males and females.  The NOAEL was 5
mg/kg/day.

In a combined chronic toxicity/carcinogenicity study 50 Fischer
(F344/DuCrj) rats/sex/dose were exposed to Tolfenpyrad over 104 weeks in
the diet at concentrations of 0, 15, 40, or 80 ppm (equivalent to 0/0,
0.561/0.686, 1.50/1.85, and 3.07/3.79 mg/kg/day in males/females). The
LOAEL was 40 ppm (equivalent to 1.50/1.85 mg/kg/day in males/females),
based on decreased body weight, body weight gain, and food consumption
of females, gross changes in the  Harderian glands of males, and
histopathological changes in the liver, kidney and mesenteric lymph
nodes of females and the kidney of males.  The NOAEL was 15 ppm
(equivalent to 0.561/0.686 mg/kg/day in males/females).  In a
carcinogenicity study Tolfenpyrad was administered in the diet to CD1
mice (50/sex/dose) for up to 18 months at doses of 0, 15 or 150 ppm
(equivalent to 0, 2.2/2.8, and 20.8/27.1 mg/kg bw/day in males/females).
 An additional group of 50 mice/sex/dose was treated similarly at a dose
of 500 ppm for Weeks 1-12, 400 ppm for Weeks 13-19, and 300 ppm for
Weeks 20-79 (60.9/75.9 mg/kg bw/day in males/females).  The dose for the
high group was adjusted twice due to observed toxicity.  The LOAEL is
150 ppm (equivalent to 21/27 mg/kg bw/day in males/females), based on
decreased body weights, body weight gains, food consumption in both
sexes, and clinical signs (increased incidence of missing ears in males
and ear sores and scabs in females).  The NOAEL is 15 ppm (equivalent to
2.2/2.8 mg/kg/day in males/females).  Tolfenpyrad was not tumorogenic in
any of the long-term studies.

	7. Animal metabolism. [In a series of oral metabolism studies in the
rat, Tolfenpyrad showed rapid absorption with maximum blood
concentrations at 2 to 6 hours post-dosing at the low dose, 4 to 12
hours at the high dose and 8 hours following multiple doses of
Tolfenpyrad.  Tolfenpyrad was rapidly excreted with over half of the
material eliminated in 24 hours and with most eliminated in 48 hours.
The majority of Tolfenpyrad was excreted in the feces, with most of the
product showing excretion via the bile.  Generally the highest
concentrations were observed in the liver, kidney, brown fat and heart.
Radioactivity concentrations dropped substantially from 12 to 168 hours
post-dosing.  Tolfenpyrad was metabolized by oxidation followed by
conjugation (glucuronide, sulfate, asparagines or taurine).  Parent
Tolfenpyrad represented a minor component of the excreted material.
Dermal penetration studies showed 13% absorption at 24 hours in the
mid-dose group.]

	8. Metabolite toxicology.  [A major metabolite (OH-PT) was evaluated in
the bacterial gene mutation assay and was negative.]

	9. Endocrine disruption. [There is no evidence to suggest that
Tolfenpyrad has any primary endocrine disruptive potential.
Reproductive and developmental findings show no evidence of enhanced
sensitivity of the young.  Nichino America, Inc. will conduct any
studies that may be required under EPA’s Endocrine Disruptor Screening
Program.]

C. Aggregate Exposure

	1. Dietary exposure. [Acute and chronic dietary risk analyses were
conducted to estimate the potential Tolfenpyrad residues in/on the
following crops: potatoes, head and leaf lettuce, spinach, leafy
petioles crop group 4B, head and stem brassica crop group 5A, leafy
brassica crop group 5B, fruiting vegetables crop group 8, cucurbit crop
group 9, citrus crop group 10,  pome fruit crop group 11, stone fruit
crop group 12, tree nut crop group 14, pistachio, cottonseed oil, milk,
and meat, grapes and cottonseed oil using LifeLineTM version 5.0.0.
Residue estimates for water consumption were based on PRZM3/EXAMS.]

	i. Food. [The acute exposure was based on the following assumptions:
residues at tolerance levels, 100% crop treated and default processing
factors for all proposed commodities. The chronic exposure was based on
the following assumptions:  100% crop treated, average crop residue as
determined by field trial residue studies, processing factors as
determined by processing studies.  Processing default factors were used
for commodities without processing studies.  Potential water and
drinking water values from acute surface water estimates from
PRZM3/EXAMS were used for both acute and chronic assessments and
represented the worst case analysis.  The Health Effects Division (HED
Decision No. 394868, June 3, 2010) determined there was no potential for
increased susceptibility to infants and children so the special FQPA
safety factor was set at 1X.  The acute dietary aPAD was set at 0.1
mg/kg/day based on the acute neurotoxicity study endpoint of systemic
toxicity.  The cPAD was determined to be 0.006 mg/kg/day based on the
NOEL from the rat chronic/oncogenicity study.  The database uncertainty
factor used to establish both the aPAD and cPAD was 100x to account for
interspecies and intraspecies variations.  No cancer assessments were
performed since Tolfenpyrad had no carcinogenic potential.  The
resulting exposure modeling estimated the acute food exposure estimate
at the 95th percentile all sub-populations was less than HED’s level
of concern (35.7% aPAD).  Children aged 1 to 2 were shown to be the most
exposed sub-population representing 74.1% of the aPAD. The chronic food
exposure estimates were also less than HED’s level of concern (US
population, 22% cPAD; children 1-2 years old were the most highly
exposed population at 46% cPAD).]

	ii. Drinking water. [Assessments for drinking water exposure were built
into the dietary assessment and have thus, already been included in the
exposure assessments.]

	2. Non-dietary exposure. [Because of potential residential uses on
ornamentals, an assessment of dermal and inhalation exposures and risks
was made.  Based on mixing/loading  application and re-entry MOEs for
occupational exposure that represent exposure over an 8 hour time frame
and exposure tasks that are unlikely  to be duplicated in a residential
setting,  it was determined that the non-dietary exposure risk was
minimal and of no concern.  Exposure to children is not expected.]

D. Cumulative Effects

	[A determination has not been made that Tolfenpyrad has a common
mechanism of toxicity with other substances. Tolfenpyrad does not appear
to produce a common toxic metabolite with other substances. A cumulative
risk assessment was, therefore, not performed for this analysis.
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.”  Unlike other pesticides for which EPA
has followed a cumulative risk approach based on a common mechanism of
toxicity, EPA has not made a common mechanism of toxicity finding as to
Tolfenpyrad and any other substances and Tolfenpyrad does not appear to
produce a toxic metabolite produced by other substances.  For the
purposes of this tolerance action, therefore, EPA has not assumed that
Tolfenpyrad has 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 the policy statements released by EPA's
OPP concerning common mechanism determinations and procedures for
cumulating effects from substances found to have a common mechanism on
EPA's web site at http://www.epa.gov/pesticides/cumulative/.]

E. Safety Determination

	1. U.S. population.

[i. Acute risk.  Using the conservative assumptions discussed above,
based on the completeness and reliability of the toxicity data, it is
concluded that aggregate exposure to the proposed uses of Tolfenpyrad
are estimated at 0.0361 mg/kg/day and will utilize 35.7 % of the acute
reference dose for the general US population. This estimate is extremely
conservative as it is based on all default assumptions.  Drinking water
and other water consumption scenarios were included in the dietary risk
assessment modeling.

ii. Chronic Risk.  [Based on the toxicology data base and available
information on anticipated residues, the chronic dietary exposure to the
U.S. Population (total) was estimated at 0.00132 mg/kg/day and was 21.9
% of the estimated chronic population adjusted dose (cPAD).  Drinking
water and other potential water consumption were included in the dietary
risk assessment modeling.  Based on these assessments, it can be
concluded that there is reasonable certainty of no harm to the U.S.
Population or any population subgroup from exposure to Tolfenpyrad.]

	2. Infants and children. [Children aged 1 to 2 were the most highly
exposed subpopulation and utilized 74.1% of the aPAD.  This estimate is
extremely conservative as it is based on all default assumptions.
Children aged 1 to 2 were the most highly exposed subpopulation and
utilized 45.7% of the cPAD.  Drinking water and other potential water
consumption were included in all dietary risk assessment modeling.
Based on these assessments, it can be concluded that there is reasonable
certainty of no harm to infants or children from exposure to
Tolfenpyrad.]

F. International Tolerances

	[No Codex Maximum Residue Levels (MRL) have been established for
residues of tolfenpyrad in raw agricultural commodities.  Tolerances
have been established in Japan for Tolfenpyrad on the following crops:
cabbage at 0.3 ppm, broccoli at 1 ppm, head and leaf lettuce 10 ppm,
tomato at 2 ppm, sweet pepper at 3 ppm, eggplant at 2 ppm, cucucmber at
1 pm, watermelon at 0.05 ppm, oranges, lemons, grapefruit  at 3 ppm,
pear at 2 ppm, peaches at 0. 2 ppm, nectarine at 5 ppm, tea at 20 ppm.]

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