[Federal Register: July 6, 2007 (Volume 72, Number 129)]
[Notices]
[Page 37064-37065]
[DOCID:fr06jy07-116]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-55975; File No. SR-ISE-2007-48]

Self-Regulatory Organizations; International Securities Exchange,
LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule
Change Relating to Fee Changes

June 28, 2007.
    Pursuant to section 19(b)(1) of the Securities Exchange Act of 1934
(``Act'')\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on June 15, 2007, the International Securities Exchange, LLC (``ISE''
or ``Exchange'') filed with the Securities and Exchange Commission
(``Commission'') the proposed rule change as described in Items I, II,
and III below, which Items have been substantially prepared by ISE. ISE
filed the proposal pursuant to Section 19(b)(3)(A)(ii) of the Act \3\
and Rule 19b-4(f)(2) \4\ thereunder, as establishing or changing a due,
fee, or other charges applicable to a member, which renders the
proposed rule change effective upon filing with the Commission. 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\ 17 CFR 240.19b-4.
    \3\ 15 U.S.C. 78s(b)(3)(A)(ii).
    \4\ 17 CFR 240.19b-4(f)(2).
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    ISE is proposing to amend its Schedule of Fees to: (1) Remove the
surcharge fee for transactions in options on the iShares Russell
2000[supreg] Index Fund (``IWM''), the iShares Russell 2000[supreg]
Value Index Fund (``IWN''), the iShares Russell 2000[supreg] Growth
Index Fund (``IWO''), the iShares Russell 1000[supreg] Value Index Fund
(``IWD'') and the iShares Russell 1000[supreg] Index Fund (``IWB'');
and (2) raise the surcharge fee for transactions in options on the
Russell 1000[supreg] Index (``RUI''), the Russell 2000[supreg] Index
(``RUT''), and the Mini Russell 2000[supreg] Index (``RMN''). The text
of the proposed rule change is available at ISE, http://www.iseoptions.com
, and 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 Exchange included statements
concerning the purpose of, and basis for, the proposed rule change 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 Exchange 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
Statutory Basis for, the Proposed Rule Change

1. Purpose
    The Exchange is proposing to amend its Schedule of Fees to: (1)
Remove the surcharge fee previously adopted for transactions in options
on IWM, IWN, IWO, IWD,\5\ and IWB; \6\ and (2) raise the surcharge fee
previously adopted for transactions in options on RUI, RUT and RMN.\7\
The Exchange is proposing to remove the surcharge fee from its Schedule
of Fees because it no longer pays a license fee to the Frank Russell

Company (``Russell'') in connection with transactions in options on
IWM, IWN, IWO, IWD and IWB. Accordingly, there is no longer a need for
this surcharge fee. The Exchange will continue to charge an execution
fee and a comparison fee for transactions in options on IWM, IWN, IWO,
IWD and IWB.
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    \5\ See Securities Exchange Act Release No. 47075 (December 20,
2002), 67 FR 79673 (December 30, 2002) (SR-ISE-2002-29).
    \6\ See Securities Exchange Act Release No. 47564 (March 24,
2003), 68 FR 15256 (March 28, 2003) (SR-ISE-2003-13).
    \7\ See Securities Exchange Act Release No. 51858 (June 16,
2005), 70 FR 36218 (June 22, 2005) (SR-ISE-2005-26).
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    Additionally, pursuant to a revised license agreement between
Russell and ISE in connection with the listing and trading of options
on RUI, RUT and RMN, and to defray the increased licensing costs, the
Exchange is raising its surcharge fee from $0.10 per contract to $0.15
per contract for trading in options on RUI, RUT and RMN. The Exchange
believes charging the participants that trade this instrument is the
most equitable means of recovering the costs of the license. However,
because of competitive pressures in the industry, the Exchange proposes
to continue excluding Public Customer Orders \8\ from this surcharge
fee. Accordingly, this surcharge fee shall continue to be charged only
to Exchange members with respect to non-Public Customer Orders (e.g.,
ISE Market Maker, non-ISE Market Maker & Firm Proprietary orders) and
shall apply to certain Linkage Orders under a pilot program that is set
to expire on July 31, 2007.\9\ The Exchange will, however, continue to
charge an execution fee and a comparison fee for transactions in
options on RUI, RUT and RMN.
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    \8\ Public Customer Order is defined in Exchange Rule 100(a)(39)
as an order for the account of a Public Customer. Public Customer is
defined in Exchange Rule 100(a)(38) as a person that is not a broker
or dealer in securities.
    \9\ Linkage Orders are defined in ISE Rule 1900(10). Under a
pilot program that is set to expire on July 31, 2007, these fees
will also be charged to Principal Acting as Agent Orders and
Principal Orders (as defined in ISE Rule 1900(10)(i)-(ii)). See
Securities Exchange Act Release No. 54204 (July 25, 2006), 71 FR
43548 (August 1, 2006) (SR-ISE-2006-38).
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2. Statutory Basis
    The basis under the Act for this proposed rule change is the
requirement under Section 6(b)(4) \10\ that the rules of an exchange
provide for the equitable allocation of reasonable dues, fees, and
other charges among its members and issuers and other persons using its
facilities.
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    \10\ 15 U.S.C. 78f(b)(4).
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B. Self-Regulatory Organization's Statement on Burden on Competition

    ISE does not believe that the proposed rule change will result in
any burden on competition that is not necessary or appropriate in
furtherance of the purposes of the Act.

C. Self-Regulatory Organization's Statement on Comments on the Proposed
Rule Change Received Form Members, Participants, or Others

    The Exchange has not solicited, and does not intend to solicit,
comments on this proposed rule change. The Exchange has not received
any unsolicited written comments from members or interested parties.

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

    The foregoing proposed rule change has become effective upon filing
with the Commission pursuant to Section 19(b)(3)(A)(ii) of the Act \11\
and Rule 19b-4(f)(2) \12\ thereunder, because it establishes or changes
a due, fee, or other charge applicable only to a member.
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    \11\ 15 U.S.C. 78s(b)(3)(A)(ii).
    \12\ 17 CFR 240.19b-4(f)(2).
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    At any time within 60 days of the filing of the proposed rule
change, the Commission may summarily abrogate 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.

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 e-mail to<EMAIL_ADDRESS>Please include

File Number SR-ISE-2007-48 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-ISE-2007-48. This file
number should be included on the subject line if e-mail 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 Internet 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 inspection and
copying in the Commission's Public Reference Room, 100 F Street, NE.,
Washington, DC 20549, on official business days between the hours of 10
a.m. and 3 p.m. Copies of such filing also will be available for
inspection and copying at the principal office of ISE. 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 Number SR-ISE-2007-48 and should be
submitted on or before July 27, 2007.

    For the Commission, by the Division of Market Regulation,
pursuant to delegated authority.\13\
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    \13\ 17 CFR 200.30-3(a)(12).
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Florence E. Harmon,
Deputy Secretary.
[FR Doc. E7-13070 Filed 7-5-07; 8:45 am]

BILLING CODE 8010-01-P


[Federal Register Volume 83, Number 166 (Monday, August 27, 2018)]
[Notices]
[Page 43674]
[FR Doc No: 2018-18409]

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ENVIRONMENTAL PROTECTION AGENCY

[9982-65-OA]

Meetings of the Local Government Advisory Committee and the Small
Communities Advisory Subcommittee

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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    The Local Government Advisory Committee (LGAC) will meet in
Washington, DC, on Thursday, September 13, 2018, 9:30 a.m.-5:35 p.m.
(EDT), and Friday, September 14,, 2018, 10:45 a.m.-12:30 p.m. (EDT).
The focus of the Committee meeting will be on issues pertaining to
cooperative federalism; water and water infrastructure issues; per- and
polyfluoroalkyl substances (PFAS); superfund and brownfields; and other
issues in EPA's Strategic Plan.
    The Small Communities Advisory Subcommittee (SCAS) will meet in
Washington, DC, on Friday, September 14, 2018, 8:30 a.m.-10:00 a.m.
(EDT). The Subcommittee will discuss water infrastructure, agricultural
issues, brownfields and other issues and recommendations to the
Administrator regarding environmental issues affecting small
communities.
    These are open meetings, and all interested persons are invited to
participate. The SCAS will hear comments from the public between 9:00
a.m. and 9:10 a.m. on Friday, September 14, 2018, and the LGAC will
hear comments from the public between 10:50 a.m. and 11:00 a.m. on
Friday, September 14, 2018. Individuals or organizations wishing to
address the Subcommittee or the Committee will be allowed a maximum of
five minutes to present their point of view. Also, written comments
should be submitted electronically to [email protected]. Please
contact the Designated Federal Officer (DFO) at the number listed below
to schedule a time on the agenda. Time will be allotted on a first-come
first-serve basis, and the total period for comments may be extended if
the number of requests for appearances requires it.

ADDRESSES: The Small Communities Advisory Subcommittee meetings will be
held at the U.S. Environmental Protection Agency, Rachel Carson Great
Room (3000 WJCS), accessible from the William Jefferson Clinton South
entrance, Third Floor, 1200 Pennsylvania Ave. NW, Washington, DC 20460.
    The Local Government Advisory Committee meetings will be held at
the U.S. Environmental Protection Agency, Rachel Carson Great Room
(3000 WJCS), accessible from the William Jefferson Clinton South
entrance, Third Floor. 1200 Pennsylvania Ave. NW, Washington, DC 20460.
    Meeting summaries will be available after the meeting online at
www.epa.gov/ocir/scas_lgac/lgac_index.htm and can be obtained by
written request to the DFO.

FOR FURTHER INFORMATION CONTACT: Local Government Advisory Committee
(LGAC) and Small Communities Advisory Subcommittee (SCAS), contact
Frances Eargle, Designated Federal Officer, at<PHONE_NUMBER> or email
at [email protected].
    Information on Services for Those With Disabilities: For
information on access or services for individuals with disabilities,
please contact Frances Eargle at<PHONE_NUMBER> or email at
[email protected]. To request accommodation of a disability,
please request it 10 days prior to the meeting, to give EPA as much
time as possible to process your request.

    Dated: August 7, 2018.
Jack Bowles,
Director, State and Local Relations, EPA's Office of Congressional and
Intergovernmental Relations.
[FR Doc. 2018-18409 Filed 8-24-18; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register: December 18, 2009 (Volume 74, Number 242)]
[Rules and Regulations]
[Page 67108-67114]
[DOCID:fr18de09-12]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2008-0704; FRL-8803-4]

Fluoxastrobin; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for combined residues
of fluoxastrobin and its Z isomer in or on berry, low growing, subgroup
13-07G; corn, field, grain; corn, field, forage; corn, field, stover;
soybean, forage; soybean, hay; soybean, hulls; soybean, seed; and
aspirated grain fractions. Arysta LifeScience North America, LLC
requested these tolerances under the Federal Food, Drug, and Cosmetic
Act (FFDCA).

DATES: This regulation is effective December 18, 2009. Objections and
requests for hearings must be received on or before February 16, 2010,
and must be filed in accordance with the instructions provided in 40
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: EPA has established a docket for this action under docket
identification (ID) number EPA-HQ-OPP-2008-0704. All documents in the
docket are listed in the docket index available at http://
www.regulations.gov. Although listed in the index, some information is
not publicly available, e.g., Confidential Business Information (CBI)
or other information whose disclosure is restricted by statute. Certain
other material, such as copyrighted material, is not placed on the
Internet and will be publicly available only in hard copy form.
Publicly available docket materials are available in the electronic
docket at http://www.regulations.gov, or, if only available in hard
copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac
Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The Docket
Facility is open from 8:30 a.m. to 4 p.m., Monday through Friday,
excluding legal holidays. The Docket Facility telephone number is (703)
305-5805.

FOR FURTHER INFORMATION CONTACT: John Bazuin, Registration Division,
Office of Pesticide Programs, Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number:
(703) 305-7381; e-mail address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

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

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

    In addition to accessing electronically available documents at
http://www.regulations.gov, you may access this Federal Register
document electronically through the EPA Internet under the ``Federal
Register'' listings at http://www.epa.gov/fedrgstr. You may also access
a frequently updated electronic version of EPA's tolerance regulations
at 40 CFR part 180 through the Government Printing Office's e-CFR cite
at http://www.gpoaccess.gov/ecfr. To access the OPPTS harmonized test
guidelines referenced in this document electronically, please go to
http://www.epa.gov/oppts and select ``Test Methods & Guidelines'' on
the left-side navigation menu.

C. Can I File an Objection or Hearing Request?

    Under section 408(g) of FFDCA, 21 U.S.C. 346a, any person may file
an objection to any aspect of this regulation and may also request a
hearing on those objections. You must file your objection or request a
hearing on this regulation in accordance with the instructions provided
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify
docket ID number EPA-HQ-OPP-2008-0704 in the subject line on the first
page of your submission. All requests must be in writing, and must be
mailed or delivered to the Hearing Clerk as required by 40 CFR part 178
on or before February 16, 2010.
    In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing that does not contain any CBI for inclusion in the public
docket that is described in ADDRESSES. Information not marked
confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA
without prior notice. Submit this copy, identified by docket ID number
EPA-HQ-OPP-2008-0704, by one of the following methods:
     Federal eRulemaking Portal http://www.regulations.gov.
Follow the on-line instructions for submitting comments.
     Mail: Office of Pesticide Programs (OPP) Regulatory Public
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001.
     Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only
accepted during the Docket Facility's normal hours of operation (8:30
a.m. to 4 p.m., Monday through Friday, excluding legal holidays).
Special arrangements should be made for deliveries of boxed
information. The Docket Facility telephone number is<PHONE_NUMBER>.

II. Petition for Tolerance

    In the Federal Register of December 3, 2008 (73 FR 73640) (FRL-
8390-4), 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
8F7437) by Arysta LifeScience North America, LLC, 15401 Weston Parkway,
Suite 150, Cary, NC 27513. The petition requested that 40 CFR 180.609
be amended by establishing tolerances for combined residues of the
fungicide fluoxastrobin, (1E)-[2-[[6-(2-chlorophenoxy)-5-fluoro-4-
pyrimidinyl]oxy]phenyl](5,6-dihydro-1,4,2-dioxazin-3-yl)methanone O-
methyloxime and its Z isomer, (1Z)-[2-[[6-(2-chlorophenoxy)-5-fluoro-4-
pyrimidinyl]oxy]phenyl](5,6-dihydro-1,4,2-dioxazin-3-yl)methanone O-
methyloxime, in or on corn, field, grain at 0.02 parts per million
(ppm); corn, field, aspirated grain fractions at 0.50 ppm; corn, field,
forage at 3.0 ppm; corn, field, fodder/stover at 4.5 ppm; soybean, seed
at 0.05 ppm; soybean, aspirated grain fractions at 0.40 ppm; soybean,
forage at 9.0 ppm; soybean, hay at 1.2 ppm; and soybean, hulls at 0.40
ppm.
    Also in the Federal Register of December 3, 2008 (73 FR 73644)
(FRL-8386-9), EPA issued a notice pursuant to section 408(d)(3) of
FFDCA, 21 U.S.C. 346a(d)(3), announcing the filing of a another
pesticide petition (PP 8F7406) by Arysta LifeScience North America,
LLC. The petition requested that 40 CFR 180.609 be amended by
establishing

tolerances for the combined residues of the fungicide fluoxastrobin,
(1E)-[2-[[6-(2-chlorophenoxy)-5-fluoro-4-pyrimidinyl]oxy]phenyl](5,6-
dihydro-1,4,2-dioxazin-3-yl)methanone O-methyloxime and its Z isomer,
(1Z)-[2-[[6-(2-chlorophenoxy)-5-fluoro-4-pyrimidinyl]oxy]phenyl](5,6-
dihydro-1,4,2-dioxazin-3-yl)methanone O-methyloxime , in or on low
growing berries (crop subgroup 13-07G) at 1.9 ppm. Each notice
referenced a summary of the appropriate petition which had been
prepared by Arysta LifeScience North America, LLC, the registrant, and
is available to the public 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
corrected the commodity and subgroup names, and replaced ``corn, field,
aspirated grain fractions'' and ``soybeans, aspirated grain fractions''
with ``aspirated grain fractions.'' EPA has also substantially
increased the tolerance for aspirated grain fractions and decreased the
tolerance for soybean, hulls. The reasons for these changes are
explained in Unit IV.C.

III. Aggregate Risk Assessment and Determination of Safety

    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a
tolerance (the legal upper limit for a pesticide chemical residue in or
on a food) only if EPA determines that the tolerance is ``safe.''
Section 408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there
is a reasonable certainty that no harm will result from aggregate
exposure to the pesticide chemical residue, including all anticipated
dietary exposures and all other exposures for which there is reliable
information.'' This includes exposure through drinking water and in
residential settings, but does not include occupational exposure.
Section 408(b)(2)(C) of FFDCA requires EPA to give special
consideration to exposure of infants and children to the pesticide
chemical residue in establishing a tolerance and to ``ensure that there
is a reasonable certainty that no harm will result to infants and
children from aggregate exposure to the pesticide chemical
residue....''
    Consistent with section 408(b)(2)(D) of FFDCA, and the factors
specified in section 408(b)(2)(D) of FFDCA, EPA has reviewed the
available scientific data and other relevant information in support of
this action. EPA has sufficient data to assess the hazards of and to
make a determination on aggregate exposure for the petitioned-for
tolerances for the combined residues of fluoxastrobin and its Z isomer
in or on aspirated grain fractions at 20 ppm; berry, low growing,
subgroup 13-07G at 1.9 ppm; corn, field, forage at 3.0 ppm; corn, field
grain at 0.02 ppm; corn, field, stover at 4.5 ppm; soybean, forage at
9.0 ppm; soybean, hay at 1.2 ppm; soybean, hulls at 0.20 ppm; soybean,
seed at 0.05 ppm. EPA's assessment of exposures and risks associated
with establishing tolerances follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered its
validity, completeness, and reliability as well as the relationship of
the results of the studies to human risk. EPA has also considered
available information concerning the variability of the sensitivities
of major identifiable subgroups of consumers, including infants and
children. Fluoxastrobin shows low acute toxicity via the oral, dermal,
and inhalation routes of exposure; is a moderate eye irritant; and is
neither a dermal irritant nor a sensitizer. Following repeated
administration, fluoxastrobin has mild or low toxicity in all tested
species other than the dog which displayed adverse liver toxicity at
considerably lower doses than those noted for other testing species.
The most common finding across all testing species is decreased body
weight. In the available toxicity studies on fluoxastrobin, there is no
estrogen, androgen, and/or thyroid mediated toxicity. Fluoxastrobin
does not produce developmental toxicity in rats or rabbits. In the rat
and rabbit developmental toxicity studies and the two-generation
reproduction rat study, there is no increased susceptibility to
prenatal or postnatal exposure to fluoxastrobin and no effects on
reproduction. Fluoxastrobin is not neurotoxic following acute or
repeated dosing in the rat. Fluoxastrobin is not genotoxic, and it is
also not carcinogenic in rats or mice. Specific information on the
studies received and the nature of the adverse effects caused by
fluoxastrobin 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 September 16, 2005 (70 FR 54640) (FRL-7719-9).

B. Toxicological Endpoints

    For hazards that have a threshold below which there is no
appreciable risk, a toxicological point of departure (POD) is
identified as the basis for derivation of reference values for risk
assessment. The POD may be defined as the highest dose at which no
adverse effects are observed (the NOAEL) in the toxicology study
identified as appropriate for use in risk assessment. However, if a
NOAEL cannot be determined, the lowest dose at which adverse effects of
concern are identified (the LOAEL) or a Benchmark Dose (BMD) approach
is sometimes used for risk assessment. Uncertainty/safety factors (UFs)
are used in conjunction with the POD to take into account uncertainties
inherent in the extrapolation from laboratory animal data to humans and
in the variations in sensitivity among members of the human population
as well as other unknowns. Safety is assessed for acute and chronic
dietary risks by comparing aggregate food and water exposure to the
pesticide to the acute population adjusted dose (aPAD) and chronic
population adjusted dose (cPAD). The aPAD and cPAD are calculated by
dividing the POD by all applicable UFs. Aggregate short-, intermediate-
, and chronic-term risks are evaluated by comparing food, water, and
residential exposure to the POD to ensure that the margin of exposure
(MOE) called for by the product of all applicable UFs is not exceeded.
This latter value is referred to as the Level of Concern (LOC).
    For non-threshold risks, the Agency assumes that any amount of
exposure will lead to some degree of risk. Thus, the Agency estimates
risk in terms of the probability of an occurrence of the adverse effect
greater than that expected in a lifetime. For more information on the
general principles EPA uses in risk characterization and a complete
description of the risk assessment process, see http://www.epa.gov/
pesticides/factsheets/riskassess.htm.
    A summary of the toxicological endpoints for fluoxastrobin used for
human risk assessment can be found at http://www.regulations.gov in the
document ``Fluoxastrobin. Human Health Risk Assessment for Proposed
Uses on Field Corn, Soybean, and the Low-Growing Berry Subgroup 13-
07G,'' at page 20 in docket ID number EPA-HQ-OPP-2008-0704.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to fluoxastrobin, EPA considered exposure under the
petitioned-for tolerances as well as all existing fluoxastrobin
tolerances in 40 CFR 180.609. EPA assessed dietary exposures from
fluoxastrobin in food as follows:
    i. Acute exposure. Quantitative acute dietary exposure and risk
assessments are performed for a food-use pesticide if

a toxicological study has indicated the possibility of an effect of
concern occurring as a result of a 1-day or single exposure. No such
effects were identified in the toxicological studies for fluoxastrobin;
therefore, a quantitative acute dietary exposure assessment was not
performed.
    ii. Chronic exposure. In conducting the chronic dietary exposure
assessment EPA used the food consumption data from the United States
Department of Agriculture 1994-1996 and 1998 CSFII. As to residue
levels in food, EPA performed an unrefined dietary (food and drinking
water) exposure assessment. The assumptions of this dietary assessment
included tolerance level residues and 100% crop treated. Experimentally
derived processing factors were applied for tomato puree, potato chips,
dry potato granules/flakes, and potato flour. For all other processed
commodities, DEEM version 7.81 default processing factors were assumed.
    iii. Cancer. The Agency has concluded that fluoxastrobin is not
likely to be carcinogenic to humans. Therefore cancer risk is not of
concern for this chemical.
    iv. Anticipated residue and percent crop treated (PCT) information.
EPA did not use anticipated residue or less than 100% crop treated
information in the dietary assessment for fluoxastrobin. Tolerance
level residues and 100% CT were assumed for all food commodities.
    2. Dietary exposure from drinking water. The Agency used screening
level water exposure models in the dietary exposure analysis and risk
assessment for fluoxastrobin in drinking water. These simulation models
take into account data on the physical, chemical, and fate/transport
characteristics of fluoxastrobin. Further information regarding EPA
drinking water models used in pesticide exposure assessment can be
found at http://www.epa.gov/oppefed1/models/water/index.htm.
    Based on the FQPA Index Reservoir Screening Tool (FIRST) and
Screening Concentration in Ground Water (SCI-GROW) models, the
estimated drinking water concentrations (EDWCs) of fluoxastrobin for
chronic exposures for non-cancer assessments are estimated to be 28
parts per billion (ppb) for surface water and less than 1 ppb for
ground water. The modeled estimate of surface drinking water
concentration was directly entered into the dietary exposure model. For
chronic dietary risk assessment, a water concentration value of 28 ppb
was used to assess the contribution of drinking water.
    3. From non-dietary exposure. The term ``residential exposure'' is
used in this document to refer to non-occupational, non-dietary
exposure (e.g., for lawn and garden pest control, indoor pest control,
termite control, and flea and tick control on pets).
    Fluoxastrobin is currently registered for the following uses that
could result in postapplication residential exposures: Turf, including
lawns and golf courses. No residential handler exposure uses have been
registered because all applications to residential turf must be made by
a certified pest control operator. EPA assessed residential exposure
using the following assumptions: Maximum application rates, no
dissipation of residues after the day of application, and no
dissipation of residues because of periodic growth and recutting of the
grass. The Agency believes that the calculated risks represent
screening level estimates. Principal potential routes of exposure
include dermal and incidental oral ingestion. The Agency has assumed
that most residential use will result in short-term exposures but that
intermediate-term exposures are also possible. It should be noted that
the new fluoxastrobin uses assessed for this final rule do not include
any residential uses.
    4. Cumulative effects from substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when
considering whether to establish, modify, or revoke a tolerance, the
Agency consider ``available information'' concerning the cumulative
effects of a particular pesticide's residues and ``other substances
that have a common mechanism of toxicity.''
    EPA has not found fluoxastrobin to share a common mechanism of
toxicity with any other substances, and fluoxastrobin does not appear
to produce a toxic metabolite produced by other substances. For the
purposes of this tolerance action, therefore, EPA has assumed that
fluoxastrobin does not have a common mechanism of toxicity with other
substances. For information regarding EPA's efforts to determine which
chemicals have a common mechanism of toxicity and to evaluate the
cumulative effects of such chemicals, see EPA's website at http://
www.epa.gov/pesticides/cumulative.

D. Safety Factor for Infants and Children

    1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA
shall apply an additional tenfold (10X) margin of safety for infants
and children in the case of threshold effects to account for prenatal
and postnatal toxicity and the completeness of the database on toxicity
and exposure unless EPA determines based on reliable data that a
different margin of safety will be safe for infants and children. This
additional margin of safety is commonly referred to as the FQPA 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. The toxicity database for
fluoxastrobin, including acceptable developmental toxicity studies in
rats and rabbits, as well as a two-generation reproduction toxicity
study, provides no indication of prenatal and/or postnatal sensitivity.
    3. Conclusion. EPA has determined that reliable data show the
safety of infants and children would be adequately protected if the
FQPA SF were reduced to 1X. That decision is based on the following
findings:
    i. The toxicity database for fluoxastrobin is considered adequate
to support endpoint selection for risk assessment and FQPA evaluation.
The submitted studies are of good quality and provide sufficient
information to determine whether fluoxastrobin poses a human health
hazard. The only data deficiency that exists is the requirement for
additional information concerning the mouse subchronic immunotoxicity
study, for potential upgrade of the study. To address the
immunotoxicity data requirement as presented in 40 CFR part 158 the
Agency has examined the entire toxicity database for fluoxastrobin and
drawn the following conclusion: There is no evidence of biologically
relevant effects on the immune system that are related to fluoxastrobin
and the overall weight of the evidence indicates that this chemical
does not directly target the immune system.
    ii. There is no indication that fluoxastrobin is a neurotoxic
chemical and there is no need for a developmental neurotoxicity study
or additional UFs to account for neurotoxicity.
    iii. There is no indication of increased quantitative or
qualitative susceptibility in rats or rabbits following in utero and/or
postnatal exposure to fluoxastrobin.
    iv. There are no residual uncertainties identified in the exposure
database. The chronic dietary food exposure assessment utilizes
proposed tolerance-level residues and 100% crop treated information for
all commodities. Use of these screening-level assessment values helps
ensure that chronic exposures and risks will not be underestimated. EPA
additionally made conservative (protective) assumptions in the ground
and surface water modeling used to assess exposure to fluoxastrobin in

drinking water. EPA used similarly conservative assumptions to assess
residential post-application exposure of children as well as incidental
oral exposure of toddlers to fluoxastrobin. These assessments will not
underestimate the exposure and risks posed by fluoxastrobin.

E. Aggregate Risks and Determination of Safety

    EPA determines whether acute and chronic pesticide exposures are
safe by comparing aggregate exposure estimates to the aPAD and cPAD.
The aPAD and cPAD represent the highest safe exposures, taking into
account all appropriate SFs. EPA calculates the aPAD and cPAD by
dividing the POD by all applicable UFs. For linear cancer risks, EPA
calculates the probability of additional cancer cases given the
estimated aggregate exposure. Short-, intermediate-, and chronic-term
risks are evaluated by comparing the estimated aggregate food, water,
and residential exposure to the POD to ensure that the MOE called for
by the product of all applicable UFs is not exceeded.
    1. Acute risk. An acute aggregate risk assessment takes into
account exposure estimates from acute dietary consumption of food and
drinking water. No adverse effect resulting from a single-oral exposure
was identified and no acute dietary endpoint was selected. Therefore,
fluoxastrobin is not expected to pose an acute risk.
    2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that chronic exposure to
fluoxastrobin from food and water will utilize 38% 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
fluoxastrobin is not expected.
    3. Short- and intermediate-term risk. Fluoxastrobin is currently
registered for uses that could result in both short- and intermediate-
term residential exposure and the Agency has determined that it is
appropriate to aggregate chronic exposure through food and water with
short- and intermediate-term residential exposures to fluoxastrobin.
Short- and intermediate-term aggregate exposure assessments take into
account short- and intermediate-term residential exposure,
respectively, plus chronic exposure to food and water (considered to be
a background exposure level). Because all short- and intermediate-term
quantitative hazard estimates (via the dermal and incidental oral
routes) for fluoxastrobin are based on the same endpoint, a screening-
level, conservative aggregate risk assessment was conducted that
combined the short-term incidental oral and intermediate-term exposure
estimates (i.e., the highest exposure estimates). The Agency believes
that most residential exposure will be short-term, based on the use
pattern.
    Using the exposure assumptions described in this unit for short-
term exposures, EPA has concluded that the combined short- and
intermediate-term food, water, and residential exposures aggregated
result in aggregate MOEs of 750 for adult males, 840 for adult females,
and 160 for children 1 to 2 years old. For adult males and adult
females, residential exposure is via the oral (background) and dermal
(primary) routes. For children 1 to 2 years old, residential exposure
is via the oral (background) and incidental oral and dermal (primary)
routes.
    4. Aggregate cancer risk for the U.S. population. The Agency has
concluded that fluoxastrobin is not likely to be carcinogenic to
humans. Therefore cancer risk is not of concern for this chemical.
    5. 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 fluoxastrobin residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (liquid chromatography/mass
spectrometry/mass spectrometry method) is available to enforce the
tolerance expression. Method No. 00604 is available for plant
commodities and Method No. 00691, Modification 001, is available for
animal commodities. The methods may be requested from: Chief,
Analytical Chemistry Branch, Environmental Science Center, 701 Mapes
Rd., Ft. Meade, MD 20755-5350; telephone number:<PHONE_NUMBER>; e-mail
address<EMAIL_ADDRESS>
B. International Residue Limits

    There are currently no established Codex, Canadian, or Mexican
Maximum Residue Levels (MRLs) for fluoxastrobin for the low-growing
berry subgroup 13-07G, soybean, or field corn commodities.

C. Revisions to Petitioned-For Tolerances

    EPA converted ``corn, field, fodder/stover'' to ``corn, field,
stover'' to conform to the terminology in the current pesticide
commodity vocabulary. The Agency also replaced ``corn, field, aspirated
grain fractions'' and ``soybean, aspirated grain fractions'' with
``aspirated grain fractions'' to conform to the terminology in the
current pesticide commodity vocabulary. The proposed tolerances of 0.50
ppm in or on corn, field, aspirated grain fractions and 0.40 ppm in or
on soybean, aspirated grain fractions were changed to a tolerance of 20
ppm in or on aspirated grain fractions based on current guidance, which
recommends that the established tolerance be based on the aspirated
grain fraction that has the highest residues. In this case it is
soybean. The soybean highest available field trial (HAFT) residue of
0.031 ppm multiplied by the expected processing factor for aspirated
grain fractions of 611x produces calculated expected residues in
aspirated grain fractions of 18.9 ppm. The fluoxastrobin tolerance in/
on aspirated grain fractions was therefore set at 20 ppm. The proposed
tolerance of 0.40 ppm in/on soybean hulls was reduced to 0.20 ppm
because the HAFT residue for soybean of 0.031 ppm is expected to
concentrate 4x in soybean hulls. This produces a calculated residue of
0.124 ppm and a decision that a tolerance of 0.20 ppm is appropriate.
In addition, the establishment of tolerances on field corn commodities
requires that the tolerance for indirect and inadvertent residues for
fluoxastrobin and its Z isomer in/on grain, cereal, forage, fodder, and
straw, group 16, be modified to apply to grain, cereal, forage, fodder,
and straw, group 16, except corn instead. The tolerance expressions in
40 CFR 180.609 are also being modified to conform to new Agency
guidance on the language tolerance expressions should conform to, but
this change does not have any other effect on the existing
fluoxastrobin tolerances.

V. Conclusion

    Therefore, tolerances are established for the combined residues of
fluoxastrobin, (1E)-[2-[[6-(2-chlorophenoxy)-5-fluoro-4-
pyrimidinyl]oxy]phenyl](5,6-dihydro-1,4,2-dioxazin-3-yl)methanone O-
methyloxime and its Z isomer, (1Z)-[2-[[6-(2-chlorophenoxy)-5-fluoro-4-
pyrimidinyl]oxy]phenyl](5,6-dihydro-1,4,2-dioxazin-3-yl)methanone O-
methyloxime, in or on aspirated grain fractions at 20 ppm; berry, low
growing, subgroup 13-07G at 1.9 ppm; corn, field, forage at 3.0 ppm;
corn, field, grain at 0.02 ppm; corn, field, stover at 4.5 ppm;
soybean, forage at 9.0 ppm; soybean,

hay at 1.2 ppm; soybean, hulls at 0.20 ppm; and soybean, seed at 0.05
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) (Public Law 104-4).
    This action does not involve any technical standards that would
require Agency consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272
note).

VII. Congressional Review Act

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

List of Subjects in 40 CFR Part 180

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

    Dated: December 8, 2009.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.

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

PART 180--[AMENDED]

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

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

0
2. Section 180.609 is revised to read as follows:

Sec.  180.609  Fluoxastrobin; tolerances for residues.

    (a) General. (1) Tolerances are established for residues of
fluoxastrobin, including its metabolites and degradates, in or on the
commodities in the table below. Compliance with the tolerance levels
specified below is to be determined by measuring only fluoxastrobin,
(1E)-[2-[[6-(2-chlorophenoxy)-5-fluoro-4-pyrimidinyl]oxy]phenyl](5,6-
dihydro-1,4,2-dioxazin-3-yl)methanone O-methyloxime and its Z isomer,
(1Z)-[2-[[6-(2-chlorophenoxy)-5-fluoro-4-pyrimidinyl]oxy]phenyl](5,6-
dihydro-1,4,2-dioxazin-3-yl)methanone O-methyloxime, calculated as the
stoichiometric equivalent of fluoxastrobin.

------------------------------------------------------------------------
                                                             Parts per
                        Commodity                             million
------------------------------------------------------------------------
Aspirated grain fractions...............................              20
Berry, low growing, subgroup 13-07G.....................             1.9
Corn, field, forage.....................................             3.0
Corn, field, grain......................................            0.02
Corn, field, stover.....................................             4.5
Leaf petioles subgroup 4B...............................             4.0
Peanut..................................................           0.010
Peanut, hay.............................................            20.0
Peanut, refined oil.....................................           0.030
Soybean, forage.........................................             9.0
Soybean, hay............................................             1.2
Soybean, hulls..........................................            0.20
Soybean, seed...........................................            0.05
Tomato, paste...........................................             1.5
Vegetable, fruiting, group 8............................             1.0
Vegetable, tuberous and corm, subgroup 1C...............           0.010
------------------------------------------------------------------------

    (2) Tolerances are established for residues of fluoxastrobin,
including its metabolites and degradates, in or on the commodities in
the table below. Compliance with the tolerance levels specified below
is to be determined by measuring only fluoxastrobin, (1E)-[2-[[6-(2-
chlorophenoxy)-5-fluoro-4-pyrimidinyl]oxy]phenyl](5,6-dihydro-1,4,2-
dioxazin-3-yl)methanone O-methyloxime, its Z isomer, (1Z)-[2-[[6-(2-
chlorophenoxy)-5-fluoro-4-pyrimidinyl]oxy]phenyl](5,6-dihydro-1,4,2-
dioxazin-3-yl)methanone O-methyloxime, and its phenoxy-
hydroxypyrimidine, 6-(2-chlorophenoxy)-5-fluoro-4-pyrimidinol,
calculated as the stoichiometric equivalent of fluoxastrobin.

------------------------------------------------------------------------
                                                             Parts per
                        Commodity                             million
------------------------------------------------------------------------
Cattle, fat.............................................            0.10
Cattle, meat............................................            0.05
Cattle, meat byproducts.................................            0.10
Goat, fat...............................................            0.10
Goat, meat..............................................            0.05
Goat, meat byproducts...................................            0.10
Horse, fat..............................................            0.10
Horse, meat.............................................            0.05
Horse, meat, byproducts.................................            0.10
Milk....................................................            0.02
Milk, fat...............................................            0.50
Sheep, fat..............................................            0.10
Sheep, meat.............................................            0.05
Sheep, meat byproducts..................................            0.10
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. Tolerances are established
for the indirect or inadvertent residues of

fluoxastrobin, including its metabolites and degradates, in or on the
commodities in the table below, when present therein as a result of the
application of fluoxastrobin to the growing crops listed in paragraph
(a)(1) of this section. Compliance with the tolerance levels specified
below is to be determined by measuring only fluoxastrobin, (1E)-[2-[[6-
(2-chlorophenoxy)-5-fluoro-4-pyrimidinyl]oxy]phenyl](5,6-dihydro-1,4,2-
dioxazin-3-yl)methanone O-methyloxime and its Z isomer, (1Z)-[2-[[6-(2-
chlorophenoxy)-5-fluoro-4-pyrimidinyl]oxy]phenyl](5,6-dihydro-1,4,2-
dioxazin-3-yl)methanone O-methyloxime, calculated as the stoichiometric
equivalent of fluoxastrobin.

------------------------------------------------------------------------
                                                             Parts per
                        Commodity                             million
------------------------------------------------------------------------
Alfalfa, forage.........................................           0.050
Alfalfa, hay............................................            0.10
Cotton, gin byproducts..................................           0.020
Grain, cereal, forage, fodder, and straw, group 16,                 0.10
 except corn............................................
Grass, forage...........................................            0.10
Grass, hay..............................................            0.50
Vegetable, foliage of legume, group 7...................           0.050
------------------------------------------------------------------------

[FR Doc. E9-30039 Filed 12-17-09; 8:45 am]

BILLING CODE 6560-50-S