[Federal Register Volume 78, Number 236 (Monday, December 9, 2013)]
[Notices]
[Pages 73912-73914]
[FR Doc No: 2013-29258]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-70967; File No. SR-ISE-2013-62]

Self-Regulatory Organizations; International Securities Exchange,
LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule
Change To Extend the Pilot Program That Eliminated the Position and
Exercise Limits for Options on SPDR S&P 500 ETF

December 3, 2013.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(the ``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given
that on November 20, 2013, the International Securities Exchange, LLC
(the ``Exchange'' or the ``ISE'') filed with the Securities and
Exchange 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\ 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

    The ISE proposes to amend its rules to extend the pilot program
that eliminated position and exercise limits for physically-settled
options on the SPDR S&P ETF Trust (``SPY'') (``SPY Pilot Program'').
The text of the proposed rule change is available on the

Exchange's Web site www.ise.com, at the principal office of the
Exchange, and at 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 self-regulatory organization
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 self-regulatory organization
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
    ISE proposes to amend Supplementary Material .01 to ISE Rule 412
and Supplementary Material .01 of ISE Rule 414 to extend the time
period of the SPY Pilot Program, which is scheduled to expire on
December 5, 2013,\3\ through February 5, 2015. This filing is based on
a filing recently submitted by NYSE MKT LLC, which extends the SPY
Pilot Program for an additional fourteen months on that exchange.\4\
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    \3\ See Exchange Act Release No. 68000 (October 5, 2012), 77 FR
62300 (October 12, 2012) (SR-ISE-2012-81).
    \4\ See Securities Exchange Act Release No. 70734 (October 22,
2013), 78 FR 64255 (October 28, 2013) (SR-NYSEMKT-2013-83).
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    This filing does not propose any substantive changes to the SPY
Pilot Program. In proposing to extend the SPY Pilot Program, the
Exchange reaffirms its consideration of several factors that supported
the original proposal of the SPY Pilot Program, including (1) the
liquidity of the option and the underlying security, (2) the market
capitalization of the underlying security and the related index, (3)
the reporting of large positions and requirements surrounding margin,
and (4) financial requirements imposed by ISE and the Commission.
    In the original proposal to establish the SPY Pilot Program, the
Exchange stated that if it were to propose an extension, permanent
approval or termination of the program, the Exchange would submit,
along with any filing proposing such amendments to the program, a
report providing an analysis of the SPY Pilot Program covering the
first twelve (12) months during which the SPY Pilot Program was in
effect (the ``Pilot Report'').\5\ However, because not all self-
regulatory organizations (``SROs'') have adopted similar rules
eliminating position limits on SPY and market participants that are
members of such SROs are required to comply with the more restrictive
SPY position limits, no market participants have availed themselves of
the SPY Pilot Program. As a result, there is no meaningful data
available to compile the Pilot Report at this time and therefore the
Exchange is not filing a Pilot Report with this extension request. The
Exchange believes it is appropriate to extend the SPY Pilot Program to
provide time for other SROs to adopt similar rules eliminating position
limits on SPY so that the Exchange can prepare a meaningful Pilot
Report if it were to propose any further extension, permanent approval
or termination of the program.
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    \5\ See Exchange Act Release No. 68000 (October 5, 2012), 77 FR
62300 (October 12, 2012) (SR-ISE-2012-81).
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    As with the original proposal to establish the SPY Pilot Program,
the Exchange represents that the Pilot Report will be submitted within
thirty (30) days of the end of the first twelve (12) months of the
extended SPY Pilot Program time period and will cover the twelve months
just ended. The Pilot Report will detail the size and different types
of strategies employed with respect to positions established as a
result of the elimination of position limits in SPY. In addition, the
Pilot Report will note whether any problems resulted due to the no
limit approach and any other information that may be useful in
evaluating the effectiveness of the SPY Pilot Program. The Pilot Report
will compare the impact of the SPY Pilot Program, if any, on the
volumes of SPY options and the volatility in the price of the
underlying SPY shares, particularly at expiration. In preparing the
report the Exchange will utilize various data elements such as volume
and open interest. In addition the Exchange will make available to
Commission staff data elements relating to the effectiveness of the SPY
Pilot Program.
    The Exchange also proposes to adopt rule text to codify that the
SPY Pilot Program is subject to a pilot period that ends on February 5,
2015.
2. Statutory Basis
    The Exchange believes that the proposed rule change is consistent
with the Securities Exchange Act of 1934 \6\ (the ``Act'') in general,
and furthers the objectives of Section 6(b)(5) of the Act \7\ in
particular, in that it is designed to prevent fraudulent and
manipulative acts and practices, to promote just and equitable
principles of trade, to foster cooperation and coordination with
persons engaged in facilitating transactions in securities, to remove
impediments to and perfect the mechanism of a free and open market and
a national market system, and, in general to protect investors and the
public interest. The Exchange believes that extending the SPY Pilot
Program promotes just and equitable principles of trade by permitting
market participants, including market makers, institutional investors
and retail investors, to establish greater positions when pursuing
their investment goals and needs.
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    \6\ 15 U.S.C. 78f(b).
    \7\ 15 U.S.C. 78f(b)(5).
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B. Self-Regulatory Organization's Statement on Burden on Competition

    The Exchange does not believe that the proposed rule change will
impose any burden on competition not necessary or appropriate in
furtherance of the purposes of the Act. The proposed rule change is not
designed to address any aspect of competition, whether between the
Exchange and its competitors, or among market participants. Instead,
the proposed rule change is designed to allow the SPY Pilot Program to
continue while other SROs adopt similar provisions and meaningful data
can be compiled into a Pilot Report.

C. Self-Regulatory Organization's Statement on Comments on the Proposed
Rule Change Received From 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 written comments from members or other interested parties.

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

    Because the foregoing proposed rule change does not significantly
affect the protection of investors or the public interest, does not
impose any significant burden on competition, and, by its terms, does
not become operative for 30 days from the date on which it was filed,
or such shorter time as the Commission may designate, it has become
effective pursuant to Section

19(b)(3)(A) of the Act \8\ and Rule 19b-4(f)(6) thereunder.\9\ The
Exchange provided 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 the proposed rule change as required by Rule 19b-
4(f)(6).
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    \8\ 15 U.S.C. 78s(b)(3)(A).
    \9\ 17 CFR 240.19b-4(f)(6).
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    A proposed rule change filed under Rule 19b-4(f)(6) \10\ normally
does not become operative prior to 30 days after the date of the
filing. However, pursuant to Rule 19b-4(f)(6)(iii),\11\ 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. The Exchange
believes that waiver of the 30-day operative delay is consistent with
the protection of investors and the public interest because it will
benefit market participants as it will allow the SPY Pilot Program to
continue uninterrupted. The Commission believes that waiving the 30-day
operative delay is consistent with the protection of investors and the
public interest. Therefore, the Commission hereby waives the 30-day
operative delay and designates the proposal operative upon filing.\12\
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    \10\ 17 CFR 240.19b-4(f)(6).
    \11\ 17 CFR 240.19b-4(f)(6)(iii).
    \12\ 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 to
determine whether the proposed rule should be approved or disapproved.

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 Number SR-ISE-2013-62 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 Number SR-ISE-2013-62. 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 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 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 the 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 Number SR-ISE-2013-62 and should be
submitted on or before December 30, 2013.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\13\
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    \13\ 17 CFR 200.30-3(a)(12).
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Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2013-29258 Filed 12-6-13; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 81, Number 32 (Thursday, February 18, 2016)]
[Notices]
[Pages 8291-8294]
[FR Doc No: 2016-03267]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-77111; File No. SR-NYSEARCA-2016-29]

Self-Regulatory Organizations; NYSE Arca, Inc.; Notice of Filing
and Immediate Effectiveness of Proposed Rule Change Modifying the Arca
Options Deep Market Data Product

February 11, 2016.
    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 February 4, 2016, NYSE Arca, Inc. (the ``Exchange'' or
``NYSE Arca'') 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

    The Exchange proposes to modify the Arca Options Deep market data
product. The proposed rule change is available on the Exchange's Web
site at www.nyse.com, at the principal office of the Exchange, and at
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 self-regulatory organization
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 those 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 parts 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 modify the Arca Options Deep market data
product.
    The Exchange currently offers the following real-time options
market data feeds: ``Arca Options Top,'' ``Arca Options Deep,'' and
``Arca Options Complex'' (the ``Arca Options Products''). ``Arca
Options Top'' is a single market data product that combines last sale
data, best bids and offers (``BBO''), order imbalance information and
series status and underlying status messages (collectively called
security status messages). ``Arca Options Deep'' is also a single
market data product that provides subscribers NYSE Arca Options quotes
and orders at the first three price levels in each series on a real-
time basis. ``Arca Options Complex,'' also a single market data
product, provides subscribers NYSE Arca Options quote and trade
information (including orders/quotes, requests for responses, and
trades) for the complex order book on a real-time basis.\4\
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    \4\ See Rule 6.62(e), which defines complex orders.
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    The Exchange charges a single fee for Arca Options Top and
subscribers of Arca Options Top receive all three data feeds described
above. The Exchange charges a separate fee for Arca Options Complex for
subscribers that seek to obtain this data feed on a standalone
basis.\5\
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    \5\ See Securities Exchange Act Release No. 68005 (Oct. 9,
2012), 77 FR 63362 (Oct. 16, 2012) (SR-NYSEArca-2012-106)
(establishing fees for certain proprietary options market data
products). See also Securities Exchange Act Release Nos. 69523 (May
6, 2013), 78 FR 27452 (May 10, 2013) (SR-NYSEArca-2013-41)
(establishing a schedule of NYSE Arca Options proprietary market
data fees); 69554 (May 10, 2013), 78 FR 28917 (May 16, 2013) (SR-
NYSEArca-2013-47) (establishing non-display usage fees and amending
the professional end-user fees); 71933 (April 11, 2014), 79 FR 21821
(April 17, 2014) (SR-NYSEArca-2014-34) (amending the professional
user fees); 73010 (Sept. 5, 2014), 79 FR 54307 (Sept. 11, 2014) (SR-
NYSEArca-2014-94) (amending fees for non-display use); 73588 (Nov.
13, 2014), 79 FR 68922 (Nov. 19, 2014) (SR-NYSEArca-2014-129)
(establishing fees for the complex order book feed); and 76023
(September 29, 2015), 80 FR 60208 (October 5, 2015) (modifying
certain proprietary options data products).

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    The Exchange proposes to modify the Arca Options Deep data feed. As
proposed, Arca Options Deep will also include security status messages,
the same data that is currently provided as part of Arca Options Top.
The proposed modification to the Arca Options Deep data feed will allow
subscribers who currently obtain depth of market data to also receive
security status messages in a single data feed. Currently, these
subscribers are required to process two data feeds to get the depth of
market data and security status information. Offering a data product
that combines, in one market data product, depth of market data and
security status messages would provide greater efficiencies and better
sequencing for vendors and subscribers that currently choose to
integrate the data after receiving it from the Exchange. As with Arca
Options Top, Arca Options Deep would provide depth of market and series
status information on a real-time basis as reported to the Options
Price Reporting Authority (``OPRA'') and disseminated on a consolidated
basis under the OPRA Plan.\6\
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    \6\ The OPRA Plan is a national market system plan approved by
the Securities and Exchange Commission (``Commission'') pursuant to
Section 11A of the Securities Exchange Act of 1934 (the ``Act'') and
Rule 608 thereunder (formerly Rule 11Aa3-2). See Securities Exchange
Act Release No. 17638 (March 18, 1981), 22 S.E.C. Docket 484 (March
31, 1981). The full text of the OPRA Plan is available at http://www.opradata.com. The OPRA Plan provides for the collection and
dissemination of last sale and quotation information on options that
are traded on the participant exchanges. Section 5.2(c) of the OPRA
Plan also permits OPRA Plan participants to disseminate
unconsolidated market information to certain of their members under
certain circumstances. The manner in which the Exchange proposes to
disseminate the products would comply with Section 5.2(c) of the
OPRA Plan, pursuant to which the Exchange may not disseminate the
products ``on any more timely basis than the same information is
furnished to the OPRA System for inclusion in OPRA's consolidated
dissemination of Options Information.''
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    The Arca Options Products would continue to be distributed in their
current format, to maintain the format of the Arca Options Products
with that of other market data products offered by the Exchange.
    The Exchange does not propose to make any changes to the fees. The
single fee charged for the Arca Options Product that comprise [sic] the
Arca Options Top, Arca Options Deep and Arca Options Complex would
continue to apply. The separate fee that now applies to Arca Options
Complex, would likewise continue to apply to the Arca Options Complex
market data product.\7\
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    \7\ The Exchange has not attached an Exhibit 5 with this
proposed rule change because the Exchange is not proposing to make
any fee changes associated with the proposed modification to the
Arca Options Deep market data product.
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    Each of the Arca Options Products would continue to be offered
through the Exchange's Liquidity Center Network (``LCN''), a local area
network in the Exchange's Mahwah, New Jersey data center that is
available to users of the Exchange's co-location services. The Exchange
would also continue to offer the products through the Exchange's Secure
Financial Transaction Infrastructure (``SFTI'') network, through which
all other users and member organizations access the Exchange's trading
and execution systems and other proprietary market data products.
    The Exchange will announce the date that the Arca Options Deep
market data product will begin to include security status messages
through a NYSE Market Data Notice.
    The proposed change is not intended to address any issues other
than those described herein, and the Exchange is not aware of any
problems that vendors or subscribers would have in complying with the
proposed change.
2. Statutory Basis
    The proposed rule change is consistent with Section 6(b) \8\ of the
Act, in general, and furthers the objectives of Section 6(b)(5) \9\ of
the Act, in particular, in that it is designed to prevent fraudulent
and manipulative acts and practices, to promote just and equitable
principles of trade, to foster cooperation and coordination with
persons engaged in facilitating transactions in securities, to remove
impediments to and perfect the mechanism of a free and open market and
a national market system and, in general, to protect investors and the
public interest, and it is not designed to permit unfair discrimination
among customers, brokers, or dealers.
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    \8\ 15 U.S.C. 78f(b).
    \9\ 15 U.S.C. 78f(b)(5).
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    The Exchange also believes this proposal is consistent with Section
6(b)(5) of the Act because it protects investors and the public
interest and promotes just and equitable principles of trade by
providing investors with improved options for receiving market data.
The proposed rule changes would benefit investors by facilitating their
prompt access to the additional real-time information contained in a
modified Arca Options Deep market data product.
    In particular, the Exchange believes that combining depth of market
data with security status messages in the Arca Options Deep product is
reasonable because it would provide greater efficiencies for vendors
and subscribers that currently choose to integrate the data after
receiving it from the Exchange. In addition, the change to the Arca
Options Deep product reflects the interests and needs of subscribers
and vendors who will no longer have to subscribe to multiple data feeds
to obtain the information they want. The Exchange believes the proposed
changes are reasonable because they would provide vendors and
subscribers with higher quality market data products.
    In adopting Regulation NMS, the Commission granted self-regulatory
organizations and broker-dealers increased authority and flexibility to
offer new and unique market data to consumers of such data. It was
believed that this authority would expand the amount of data available
to users and consumers of such data and also spur innovation and
competition for the provision of market data. The Exchange believes
that the options data product changes proposed herein are precisely the
sort of market data product evolutions that the Commission envisioned
when it adopted Regulation NMS. The Commission concluded that
Regulation NMS--by lessening regulation of the market in proprietary
data--would itself further the Act's goals of facilitating efficiency
and competition:

    [E]fficiency is promoted when broker-dealers who do not need the
data beyond the prices, sizes, market center identifications of the
NBBO and consolidated last sale information are not required to
receive (and pay for) such data. The Commission also believes that
efficiency is promoted when broker-dealers may choose to receive
(and pay for) additional market data based on their own internal
analysis of the need for such data.\10\
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    \10\ See Securities Exchange Act Release No. 51808 (June 9,
2005), 70 FR 37496 (June 29, 2005).

    By removing ``unnecessary regulatory restrictions'' on the ability
of exchanges to sell their own data, Regulation NMS advanced the goals
of the Act and the principles reflected in its legislative history.
    The Exchange further notes that the existence of alternatives to
the Exchange's products, including real-

time consolidated data, free delayed consolidated data, and proprietary
data from other sources, ensures that the Exchange is not unreasonably
discriminatory because vendors and subscribers can elect these
alternatives.
    The proposed options data products will help to protect a free and
open market by providing additional data to the marketplace and give
investors greater choices. In addition, the proposal would not permit
unfair discrimination because the products will be available to all of
the Exchange's customers and broker-dealers through both the LCN and
SFTI.

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

    In accordance with Section 6(b)(8) of the Act,\11\ the Exchange
does not believe that the proposed rule change will impose any burden
on competition that is not necessary or appropriate in furtherance of
the purposes of the Act. The market for proprietary data products is
currently competitive and inherently contestable because there is
fierce competition for the inputs necessary to the creation of
proprietary data. Numerous exchanges compete with each other for
listings, trades, and market data itself, providing virtually limitless
opportunities for entrepreneurs who wish to produce and distribute
their own market data. This proprietary data is produced by each
individual exchange, as well as other entities (such as internalizing
broker-dealers and various forms of alternative trading systems,
including dark pools and electronic communication networks), in a
vigorously competitive market. It is common for market participants to
further and exploit this competition by sending their order flow and
transaction reports to multiple markets, rather than providing them all
to a single market.
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    \11\ 15 U.S.C. 78f(b)(8).
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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 solicited or received with respect to the
proposed rule change.

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 \12\ and Rule 19b-4(f)(6) thereunder.\13\
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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    \12\ 15 U.S.C. 78s(b)(3)(A)(iii).
    \13\ 17 CFR 240.19b-4(f)(6). As required under Rule 19b-
4(f)(6)(iii), the Exchange provided the Commission with written
notice of its intent to file the proposed rule change, along with a
brief description and the 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.
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    A proposed rule change filed under Rule 19b-4(f)(6) \14\ normally
does not become operative prior to 30 days after the date of the
filing. However, pursuant to Rule 19b4-(f)(6)(iii),\15\ 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. The Commission believes
that waiver of the operative delay is consistent with investor
protection and the public interest because the proposal would allow the
Exchange to offer currently available market data in a streamlined
format that would enhance the quality of market data available to
investors and would enable investors to better monitor trading activity
on the Exchange. Accordingly, the Commission hereby waives the 30-day
operative delay and designates the proposal operative upon filing.\16\
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    \14\ 17 CFR 240.19b-4(f)(6).
    \15\ 17 CFR 240.19b-4(f)(6)(iii).
    \16\ 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. 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) \17\ of the Act to determine whether the proposed
rule change should be approved or disapproved.
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    \17\ 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 Number SR-NYSEARCA-2016-29 on the subject line.

Paper Comments

     Send paper comments in triplicate to Brent J. Fields,
Secretary, Securities and Exchange Commission, 100 F Street NE.,
Washington, DC 20549-1090.

All submissions should refer to File Number SR-NYSEARCA-2016-29. 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 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 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 the 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 Number SR-NYSEARCA-2016-29 and should
be submitted on or before March 10, 2016.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\18\
Robert W. Errett,
Deputy Secretary.
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    \18\ 17 CFR 200.30-3(a)(12).
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[FR Doc. 2016-03267 Filed 2-17-16; 8:45 am]
BILLING CODE 8011-01-P


  SEQ CHAPTER \h \r 1 Primary Evaluator

Date:  14-SEP-2006

	George F. Kramer, Ph.D., Senior Chemist

Registration Action Branch (RAB1)

Health Effects Division (HED) (7509C)

	Approved by

Date:  14-SEP-2006

	P.V. Shah, Ph.D. Branch Senior Scientist

RAB1/HED (7509C)

  SEQ CHAPTER \h \r 1 This DER was originally prepared under contract by Dynamac Corporation (1910 Sedwick Rd., Building 100, Durham, NC 27713; submitted 06/23/2006).  The DER has been reviewed by HED and revised to reflect current Office of Pesticide Programs (OPP) policies.

STUDY REPORT:

46609501.  Corley, J. (2005) Diflubenzuron:  Magnitude of the Residue on Small Grain.  Lab Project Number:  08024.02-PTR01.  Unpublished study prepared by Interregional Research Project No. 4 (IR-4).  800 p.

EXECUTIVE SUMMARY:

In a field trial conducted during the 2002 growing season in WA, diflubenzuron (2 lb/gal flowable concentrate (FlC)) was applied to a wheat crop (pre-booting growth stage) as one broadcast foliar application at rates of 0.066 or 0.646 lb ai/A.  Single bulk samples of control and treated wheat grain were harvested at commercial maturity, 83 days after treatment (DAT).  Wheat grain was processed into aspirated grain, germ, bran, flour, shorts and middlings using simulated commercial procedures.  Prior to analysis, wheat grain and processed products were stored frozen for up to 90-113 days, and one wheat germ sample was stored for up 321 days prior to analysis of diflubenzuron.  The storage conditions and intervals of processed samples are partially supported by adequate storage stability data.  The available storage stability data for rice bran may be translated to wheat bran; however, additional storage stability data for wheat flour, middlings, shorts, and germ are required.

Samples of wheat grain and its processed commodities were analyzed for residues of diflubenzuron, 4-chlorophenylurea (CPU), and 4-chloroaniline (PCA), using high-performance liquid chromatography (HPLC)/ultraviolet (UV), gas chromatography/mass spectroscopy (GC/MS), and GC/MS with selected-ion monitoring (SIM), respectively.  These methods, which are similar or based on method submissions previously deemed acceptable by the Agency, were adequately validated in conjunction with the field sample analyses.  The lowest limit of method validations (LLMVs) are 0.05 ppm for diflubenzuron and 0.005 ppm for CPU and PCA in all wheat matrices.

The results show that following one application of the test formulation at 0.066 lb ai/A (1x), individual residues of diflubenzuron, CPU, and PCA were each below the respective LOQ in/on the raw agricultural commodity (RAC) (wheat grain) for a combined total of <0.06 ppm.  The combined residues were <0.06 ppm in shorts, middlings, flour, bran, and germ, and were <2.104 ppm in aspirated grain fractions.  These data indicate that the combined residues did not concentrate in all processed fractions of wheat but did concentrate in aspirated grain fractions.  The calculated processing factor for wheat aspirated grain fraction following processing of 1x-treated wheat grain is >35.1x.

Following one application of the test formulation at 0.646 lb ai/A (10x), individual residues of diflubenzuron, CPU, and PCA were 0.147 ppm, <0.005 ppm, and <0.005 ppm, respectively in/on the RAC (wheat grain) for a combined total of <0.157 ppm.  The combined residues were <0.085 ppm in shorts, <0.06 ppm in middlings, <0.06 ppm in flour, <0.104 ppm in bran, <0.061 ppm in germ, and <28.069 ppm in aspirated grain fractions.  These data also indicate that the combined residues did not concentrate in all processed fractions of wheat but did concentrate in aspirated grain fractions.  The calculated processing factor for wheat aspirated grain fraction following processing of 10x-treated wheat grain is 180x.

STUDY/WAIVER ACCEPTABILITY/DEFICIENCIES/CLARIFICATIONS:

Under the conditions and parameters used in the study, the wheat processing data are classified as scientifically acceptable, pending submission of additional supporting storage stability data for wheat processed commodities.  Storage stability data are required demonstrating the stability of diflubenzuron, CPU, and PCA residues in all wheat processed commodities, except bran, over the storage duration of the samples from the subject processing study.  The acceptability of this study for regulatory purposes is addressed in the forthcoming U.S. EPA Residue Chemistry Summary Document, DP# 321623.

COMPLIANCE:

Signed and dated Good Laboratory Practice (GLP), Quality Assurance and Data Confidentiality statements were provided.  The study authors noted numerous minor deviations from GLP compliance at the trial site, including the collection of weather data and descriptions of the field plot.  However, these deviations do not impact the validity of the study.

A.	BACKGROUND INFORMATION

Diflubenzuron is an insecticide/acaricide (insect growth regulator) that behaves as a chitin inhibitor to suppress the growth of many leaf-eating larvae, mosquito larvae, aquatic midges, rust mite, boll weevil, and flies.  Diflubenzuron was first registered in the United States in 1979 for use as an insecticide.  The Agency issued a Registration Standard for diflubenzuron in September, 1985, (NTIS #PB86-176500).  Diflubenzuron was also the subject of a Residue Chemistry Chapter dated 11/16/84, an Addendum to the Registration Standard dated 12/4/84, and a Reregistration Standard Update dated 6/21/91.  The Reregistration Eligibility Decision (RED) for diflubenzuron was issued in August, 1997 (EPA 738-R-97-008).  Tolerances for residues of diflubenzuron are established under 40 CFR §180.377.

TABLE A.1.	Diflubenzuron Nomenclature.

Compound

Common Name	Diflubenzuron

Trade and other Names	Dimilin, Vigilante, Micromite, Adept

IUPAC Name	1-(4-chlorophenyl)-3-(2,6-difluorobenzoyl)urea

CAS Name	N-[[(4-chlorophenyl)amino]carbonyl]-2,6-difluorobenzamide

CAS Registry Number	35367-38-5

End-Use Product (EP)	2 lb/gal FlC formulation; DIMILIN® 2L (EPA Reg. No. 400-461)

Regulated Metabolite

Common name	4-chlorophenylurea (CPU)

Regulated Metabolite

Common name	4-chloroaniline (PCA)

TABLE A.2.	Physicochemical Properties of Diflubenzuron.

Parameter	Value	Reference

Melting range	230-232 °C	  HYPERLINK "http://www.arsusda.gov/acsl/services/ppdb/textfiles/DIFLUBENZURON"  http://www.arsusda.gov/acsl/services/ppdb/textfiles/DIFLUBENZURON

pH	Not available

	Density	Not available

	Water solubility (25°C)	0.08 ppm

	Solvent solubility (25°C) (ppm)	6.5 x 103     Acetone

2 x 103        Acetonitrile

2.4 x 104     Dioxane

1.04 x 105   Dimethylformamide

1.2 x 105     Dimethylsulfoxide

1 x 103        Methanol

6 x 102        Dichloromethane

	Vapor pressure (25°C)	1.2 x 10- 4 mPa

	Dissociation constant, pKa	Not available

	Octanol/water partition coefficient, Log(KOW)	3.89

	UV/visible absorption spectrum	Not available

B.	EXPERIMENTAL DESIGN

B.1.	Application and Crop Information

TABLE B.1.1.	Trial Site Conditions.

Location:

City, State; Year (Trial ID)

EP1	Application

Tank Mix/ Adjuvants

Method; Timing

Volume2	Single Rate

(lb ai/A)	RTI3

(days)	Total Rate

(lb ai/A)

	Prosser, WA; 2002 (WA41)	2 lb/gal FlC	One broadcast foliar application:  Pre-boot stage	13.66	0.066	NA	0.066	None

One broadcast foliar application:  Pre-boot stage	13.66	0.646	NA	0.646

	1 EP = End-use Product; DIMILIN® 2L

2 Gallons per acre

3 RTI = Retreatment Interval; not applicable (NA) because a single application was made at each treated plot.

B.2.	Sample Handling and Processing Procedures

Single bulk samples of control and treated wheat grain were harvested at normal crop maturity, 83 DAT.  Samples were shipped frozen to the processing facility (Texas A&M University, Bryan, TX), where samples were processed into aspirated grain, germ, bran, flour, shorts and middlings using simulated commercial procedures.  After processing, samples were collected, placed in frozen storage, and shipped frozen to the analytical laboratory (PTRL West, Inc., Hercules, CA) for analysis.

B.3.	Analytical Methodology

The wheat samples were analyzed for diflubenzuron, CPU, and PCA using a separate PTRL method for each analyte.  The methods are described in “Dimilin 25W, Dimilin 80WG, and Dimilin 2L in Almonds:  Magnitude of Residue Study, J. Rose dated September 1999."

For analysis of diflubenzuron, samples are extracted twice with acetonitrile (ACN) and centrifuged.  The supernatants are combined and partitioned with hexane.  The ACN layer is concentrated to dryness, redissolved in ACN and water, and sequentially cleaned up on a C18 solid-phase extraction (SPE) column and silica-gel SPE column.  After clean up, residues are analyzed by HPLC on a C8 or C18 column with UV detection.  The diflubenzuron limits of detection (LODs) for wheat grain and bran were calculated to be 0.012 ppm and 0.023 ppm, respectively, and the calculated limits of quantitation (LOQs) were 0.037 ppm and 0.070 ppm, respectively.  The LLMV for diflubenzuron was 0.05 ppm for each commodity.

For analysis of CPU, samples are dried with sodium sulfate and extracted with ethyl acetate.  Residues are evaporated to dryness, redissolved in acetone and petroleum ether and cleaned up on a silica-gel SPE column.  Again, residues are evaporated to dryness and redissolved in acetonitrile.  The sample is filtered and derivatized in a glass tube with heptafluorobutyric anhydride for 10 minutes.  Residues are then analyzed by GC/MS.  For wheat grain, the LOD for CPU was calculated to be 0.002 ppm and the calculated LOQ was 0.006 ppm.  The LLMV for CPU was 0.005 ppm for each commodity.

For analysis of PCA, residues are acidified with HCl and sonicated for 30 minutes at 60 °C.  NaOH and NaCl are added, and residues are extracted three times with hexane.  Residues are then partitioned with 0.1 N HCl, neutralized, and extracted with hexane.  Extracts are dried and cleaned up with a Florisil column, derivatized with heptafluorobutyric acid for 10 minutes, after which water, sodium carbonate and hexane are added.  Residues in the hexane layer are analyzed by GC/MS with SIM.  The LOD for PCA in each wheat matrix was calculated to be 0.001 ppm and the calculated LOQ was either 0.003 or 0.004 ppm.  The LLMV for PCA was 0.005 ppm for each commodity.

In conjunction with the analysis of processing samples, the above methods were validated using control samples of wheat matrices fortified with diflubenzuron, CPU or CPA at 0.005-0.5 ppm.

C.	RESULTS AND DISCUSSION

The analytical methods used to determine residues of diflubenzuron, CPU, and PCA in/on wheat grain and its processed commodities were adequately validated in conjunction with the sample analyses.  Method recoveries from concurrent analysis of samples as well as from additional method verification (see Table C.1) were generally within the acceptable range of 70-120%.  Three low recoveries (58-68%) were obtained for diflubenzuron in bran and germ, and for CPU in grain, but overall mean recoveries were acceptable.  Apparent residues of diflubenzuron, CPU, and PCA were each <LOQ in/on the untreated samples of wheat grain, shorts, middlings, flour, bran, germ, and aspirated grain fractions.  Adequate sample calculations and example chromatograms were provided.

Prior to analysis, wheat grain and processed products were stored frozen for up to 90-113 days, and one wheat germ sample was stored 321 days prior to analysis for diflubenzuron (Table C.2.1).  A concurrent freezer storage stability study was conducted with the associated wheat field trials to validate sample storage conditions and intervals of the RAC (wheat grain).  The results (Table C.2.2) show that residues of diflubenzuron are reasonably stable in/on frozen wheat grain (average corrected stored recovery of 105%) for up to 296 days.  Residues of CPU were also found to be stable in frozen wheat grain (average corrected stored recovery of 85%) for up to 348 days.  However, residues of PCA were unstable (average corrected stored recovery of 32%) after 293 days of storage.  These data support the storage conditions of samples of wheat grain and aspirated grain fractions from the wheat processing study.

No supporting storage stability data were conducted for the wheat processed commodities.  The available storage stability data (DP# 244487, G. Kramer, 2/17/1999) for processed rice bran indicate that   SEQ CHAPTER \h \r 1 diflubenzuron and CPU are stable over a ~12-month period, but that PCA is unstable in rice bran, degrading significantly after 1 month.  These data may be translated to wheat bran.

The results suggest that residues of PCA should be corrected in order to determine the residue levels that were present at the time of sample collection.  However, HED has determined that correction of PCA residues for degradation during storage would not have a significant effect on the results of this processing study because individual residues of PCA in/on wheat grain and bran were all below <0.005 ppm.

The results of the wheat processing study show that following one application of the test formulation at 0.066 lb ai/A (1x), individual residues of diflubenzuron, CPU, and PCA were each below the respective LLMV in/on the RAC (wheat grain) for a combined total of <0.06 ppm.  When the 1x-treated samples of wheat grain were processesed, the combined residues were <0.06 ppm in shorts, middlings, flour, bran, and germ and were <2.104 ppm in aspirated grain fractions.  These data indicate that the combined residues did not concentrate in all processed fractions of wheat but did concentrate in aspirated grain fractions.  The calculated processing factor for wheat aspirated grain fraction following processing of 1x-treated wheat grain is >35.1x.

Following one application of the test formulation at 0.646 lb ai/A (1x), individual residues of diflubenzuron, CPU, and PCA were 0.147 ppm, <0.005 ppm, and <0.005 ppm, respectively in/on the RAC (wheat grain) for a combined total of <0.157 ppm.  When the 10x-treated samples of wheat grain were processesed, the combined residues were <0.085 ppm in shorts, <0.06 ppm in middlings, <0.06 ppm in flour, <0.104 ppm in bran, <0.061 ppm in germ, and <28.069 ppm in aspirated grain fractions.  These data also indicate that the combined residues did not concentrate in all processed fractions of wheat but did concentrate in aspirated grain fractions.  The calculated processing factor for wheat aspirated grain fraction following processing of 10x-treated wheat grain is 180x.

TABLE C.1.	Summary of Method Recoveries of Diflubenzuron from Wheat.

Analyte

Matrix	Spike level (ppm)

Sample Size(n)

Recoveries (%)	Mean ± Std Dev (%)

Concurrent

Diflubenzuron	Grain	0.05-0.10	6	94, 95, 100, 106, 108, 116	103 (  8

CPU

0.005	6	80, 80, 80, 100, 100, 100	90 ( 11

PCA

0.005	8	86, 94, 102, 104, 106, 106, 106, 110	102 ( 8

Diflubenzuron	Bran	0.05	2	68, 98	83

CPU

0.01	2	90, 100	95

PCA

0.005	2	96, 114	105

Diflubenzuron	Flour	0.50	2	99, 99	99

CPU

0.01	2	70, 90	80

PCA

0.005	2	96, 102	99

Diflubenzuron	Germ	0.05	2	86, 86	86

CPU

0.01	2	70, 80	75

PCA

0.005	2	96, 98	97

Diflubenzuron	Middlings	0.05	2	88, 100	94

CPU

0.01	2	110, 120	115

PCA

0.005	2	92, 96	94

Method validation

Diflubenzuron	Grain	0.05-0.50	6	87, 94, 94, 96, 98, 101	95 ( 5

CPU

0.005-0.05	6	58, 72, 80, 80, 100, 120	85 ( 22

PCA

0.005-0.10	9	112, 112, 112, 114, 116, 117, 117, 119, 119	115 ( 3

Diflubenzuron	Bran	0.05-0.50	6	70, 74, 82, 84, 85, 91	81 ± 8

CPU

0.005-0.05	6	82, 84, 94, 100, 100, 100	93 ± 8

PCA

0.005-0.05	6	100, 102, 104, 105, 105, 107	104 ± 2

Diflubenzuron	Flour	0.05-0.50	6	84, 96, 98, 98, 98, 102	97 ± 7

CPU

0.005-0.05	6	80, 100, 100, 102, 102, 108	99 ± 10

PCA

0.005-0.05	6	100, 100, 100, 101, 104, 112	103 ± 5

Diflubenzuron	Germ	0.05-0.50	6	62, 70, 75, 83, 83, 84	76 ± 9

CPU

0.005-0.05	6	80, 80, 80, 94, 100, 106	90 ± 12

PCA

0.005-0.05	6	100, 102, 103, 104, 107, 110	104 ± 4

TABLE C.2.1	Summary of Storage Conditions.

Analyte

Matrix	Storage Temperature

(°C)	Actual Storage Duration (days)	Interval of Demonstrated Storage Stability (Days)

Diflubenzuron	Wheat, grain	<0	105	296 in/on wheat grain

	Aspirated Grain

98

Shorts

113	None available

	Middlings

113

Flour

106

Germ

321

Bran

98	365 in/on rice bran

CPU	Wheat, grain	<0	100	348 in/on wheat grain

	Aspirated Grain

96

Shorts

101	None available

	Middlings

101

Flour

111

Germ

111

Bran

96	338 in/on rice bran

PCA	Wheat, grain	<0	100	293 in/on wheat grain

	Aspirated Grain

92

Shorts

90	None available

	Middlings

90

Flour

96

Germ

96

Bran

92	336 in/on rice bran with degradation (>45%) after 27 days

1  Storage from processing date to analysis date.  Extracts were stored 1-4 days from extraction to analysis

TABLE C.2.2	Stability of Diflubenzuron and its Metabolites in Frozen Wheat Matrices.

Matrix

Analyte

Spike Level

(ppm)

Storage Interval (Days)	Freshly Fortified Recoveries (%)

[Average]

Stored Sample Recoveries (%)

[Average]

Average Corrected Stored Recoveries (%)

Grain	Diflubenzuron	0.5	296	86, 86

[86]	93, 88

[91]	105

	CPU

348	80, 80

[80]	59, 77

[68]	85

	PCA

293	106, 102

[104]	31, 35

[33]	32

TABLE C.3.	Residue Data from Wheat Processing Study with Diflubenzuron.

RAC	Processed Commodity	Total Rate

(lb ai/A) 	PHI

(days)	Diflubenzuron + CPU + PCA =

Combined Residues (ppm)	Processing Factor

(Combined Residues)

Grain	RAC	0.066	83	<0.05 + <0.005 + <0.005 = <0.06	--

	Shorts

	<0.05 + <0.005 + <0.005 = <0.06	1x

	Middlings

	<0.05 + <0.005 + <0.005 = <0.06	1x

	Flour

	<0.05 + <0.005 + <0.005 = <0.06	1x

	Bran

	<0.05 + <0.005 + <0.005 = <0.06	1x

	Germ

	<0.05 + <0.005 + <0.005 = <0.06	1x

	Aspirated grain

	2.094 + <0.005 + <0.005 = <2.104	>35.1

Grain	RAC	0.646	83	0.147 + <0.005 + <0.005 = <0.157	--

	Shorts

	0.075 + <0.005 + <0.005 = <0.085	0.54x

	Middlings

	<0.05 + <0.005 + <0.005 = <0.06	0.38x

	Flour

	<0.05 + <0.005 + <0.005 = <0.06	0.38x

	Bran

	0.094 + <0.005 + <0.005 = <0.104	0.66x

	Germ

	0.051 + <0.005 + <0.005 = <0.061	0.42x

	Aspirated grain

	27.920 + 0.144 + <0.005 = <28.069	180x

D.	CONCLUSION

The wheat processing study is acceptable pending submission of additional storage stability data for wheat processed commodities.  The combined residues of diflubenzuron and its CPU and PCA metabolites do not appear to concentrate in shorts, middlings, flour, bran, and germ processed from wheat grain treated at 1x and 10x the field rate.  The combined residues, however, concentrated >35.1x and 180x in aspirated grain fractions processed from wheat grain treated at 1x and 10x, respectively.

E.	REFERENCES

DP Barcodes:	  SEQ CHAPTER \h \r 1 D253043, D253041, D244487, D251221 and D251609

Subject:	  SEQ CHAPTER \h \r 1 PP#8F4925.  Diflubenzuron (Dimilin® 2L, EPA Reg #400-461) on Rice.

Amendments of 8/19/98, 11/20/98, 12/3/98, 1/21/99, 1/27/99 & 2/3/99.

Analytical Method for Metabolites, Revised Label, Additional Residue, Storage

Stability and Rotational Crop Data.

From:		G. Kramer

To:		M. Johnson/A. Sibold

Dated:		2/17/1999

MRIDs	44577601, 44689701-02, 44699201, 44692701, 44692703,<PHONE_NUMBER>, and 44707401

F.	DOCUMENT TRACKING

RDI:  RAB1 Chemists (8/23/06)

Petition Number(s):  PP#5E6965

DP#:  321623

PC Code:  108201

Template Version June 2005

	[Name of Active/Active Code/PC Code/Company/Company Code]

	DACO 7.4.5/OPPTS 860.1520/OECD IIA 6.5.4 and IIIA 8.5

	Processed Food and Feed - [matrices]

	Diflubenzuron/PC Code 108201/IR-4

	DACO 7.4.5/OPPTS 860.1520/OECD IIA 6.5.4 and IIIA 8.5

	Processed Food and Feed – Wheat

PMRA Submission No.     /DP Barcode  D######     /MRID No.

 of    NUMPAGES \* arabic \* MERGEFORMAT  9

DP# 321623/MRID No. 46609501					Page   PAGE  1  of   NUMPAGES  9


Comment Info: =================

General Comment:Visit the manufacturing facilities assocociated with the production of refractory brick and gather information in preparation for hazardous air pollutants (HAP) emissions testings of the curing ovens and periodic (bell) kilns at this plant.


[Federal Register: March 4, 2009 (Volume 74, Number 41)]
[Rules and Regulations]
[Page 9358-9365]
[DOCID:fr04mr09-7]

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

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2007-1192; FRL-8400-9]

Famoxadone; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

SUMMARY: This regulation establishes tolerances for residues of
famoxadone in or on caneberry subgroup 13-07A; cilantro, leaves; onion,
bulb, subgroup 3-07A; onion, green, subgroup 3-07B; spinach; and
vegetable, leafy, except Brassica, group 4, except spinach. It also
removes existing tolerances on lettuce, head; and caneberry, subgroup
13A that are superseded by the new tolerances on vegetable, leafy,
except Brassica, group 4, except spinach; and caneberry subgroup 13-
07A. Interregional Research Project Number 4 (IR-4) requested these
amendments under the Federal Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective March 4, 2009. Objections and
requests for hearings must be received on or before May 4, 2009, 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-2007-1192. 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: Susan Stanton, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200

Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number:
(703) 305-5218; 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 site
at http://www.gpoaccess.gov/ecfr.

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-2007-1192 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 May 4, 2009.
    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-2007-1192, 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 March 12, 2008 (73 FR 13225) (FRL-8354-
6), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21
U.S.C. 346a(d)(3), announcing the filing of pesticide petitions (PP
7E7280 and 7E7281) by Interregional Research Project Number 4 (IR-4),
500 College Road East, Suite 201 W, Princeton, NJ 08540. The petitions
requested that 40 CFR 180.587 be amended by establishing tolerances for
residues of the fungicide, famoxadone, 3-anilino-5-methyl-5-(4-
phenoxyphenyl)-1,3-oxazolidine-2,4-dione, in or on leaf petioles,
subgroup 4B at 25 parts per million (ppm) (PP 7E7280); leafy greens,
subgroup 4A and cilantro at 50 ppm; bulb vegetables, group 3-07 at 40
ppm; and caneberry, subgroup 13-07A at 10 ppm (all in PP 7E7281). IR-4
also proposed in petition 7E7281 to remove the existing tolerances in
40 CFR 180.587 for residues of the fungicide famoxadone in or on the
food commodities lettuce, head; and caneberry, subgroup 13A, which
would be superseded by the tolerances on leafy, greens, subgroup 4A;
and caneberry, subgroup 13-07A. That notice referenced a summary of the
petition prepared on behalf of IR-4 by E.I. du Pont de Nemours and
Company, the registrant, which is available to the public in the
docket, http://www.regulations.gov. Comments were received on the
notice of filing. EPA's response to these comments is discussed in Unit
IV.C.
    Based upon review of the data supporting the petition, EPA has
determined that separate tolerances at different levels are needed for
the bulb and green onion subgroups of bulb vegetables group 3-07. EPA
has also determined that tolerances should be established on
``vegetable, leafy, except Brassica, group 4, except spinach'' at 25
ppm with a separate tolerance of 50 ppm on spinach, rather than the
proposed tolerances on subgroups 4A at 50 ppm and 4B at 25 ppm. The
reasons for these changes are explained in Unit IV.D.

III. Aggregate Risk Assessment and Determination of Safety

    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a
reasonable certainty that no harm will result from aggregate exposure
to the pesticide chemical residue, including all anticipated dietary
exposures and all other exposures for which there is reliable
information.'' This includes exposure through drinking water and in
residential settings, but does not include occupational exposure.
Section 408(b)(2)(C) of FFDCA requires EPA to give special
consideration to exposure of infants and children to the pesticide
chemical residue in establishing a tolerance and to ``ensure that there
is a reasonable certainty that no harm will result to infants and
children from aggregate exposure to the pesticide chemical residue. . .
.''
    Consistent with 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 residues of famoxadone on caneberry subgroup 13-07A at
10 ppm; cilantro, leaves at 25.0 ppm; onion, bulb, subgroup 3-07A at
0.45 ppm; onion, green, subgroup 3-07B at 40 ppm; spinach at 50 ppm;
and vegetable, leafy, except Brassica, group 4, except spinach at 25
ppm. EPA's

assessment of exposures and risks associated with establishing these
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.
    Famoxadone has low acute toxicity by the oral, dermal and
inhalation routes of exposure. It is a moderate eye and skin irritant
but is not a dermal sensitizer. In subchronic and chronic feeding
studies in rats, mice, dogs and cynomolgus monkeys, famoxadone
generally caused decreased body weights and body weight gains, often
accompanied by decreased food consumption and food efficiency. A mild
regenerative hemolytic anemia was also regularly observed in these
animals as evidenced by decreased erythrocyte counts, hemoglobin and/or
hematocrit, increased reticulocytes, and other related changes in
hematologic parameters. Famoxadone also induced a mild hepatotoxicity
in treated animals characterized by elevated levels of clinical
chemistry enzymes indicative of liver damage (increased alkaline
phosphatase, alanine aminotransferase, aspartate aminotransferase, and/
or sorbitol dehydrogenase) and by histopathological lesions in the
liver (single cell or focal necrosis, hepatocellular degeneration,
diffuse fatty change, foci of eosinophilic cellular alteration,
apoptosis and increased mitotic figures). Both the anemia and the
hepatotoxicity were mild and did not significantly compromise the
overall health status of the treated animals. In repeated dose studies
the anemia, which occurred early in the studies, often appeared to be
fully compensated for in the latter stages of the studies. Although the
hepatotoxicity persisted throughout the duration of the studies, it was
mild or moderate in intensity and not severe or life-threatening.
    Additional treatment-related effects were observed in dogs that
were not observed in other species. In a 13-week feeding study,
clinical signs of neurotoxicity (myotonic twitches) were observed in
male and female dogs at the highest dose tested throughout the duration
of the study. These twitches were not observed, however, at lower doses
in the same study or in a 1-year feeding study in dogs. Also, in both
male and female dogs, famoxadone induced treatment-related cataracts in
the lens of the eye in the 13-week feeding study and in the 1-year
feeding study. The eye effects were observed at dose levels below those
at which any other effects were observed in any other species and
served as the basis for many of the risk assessments in humans.
    There was no indication of increased quantitative or qualitative
susceptibility of fetuses or offspring to famoxadone exposure in the
developmental toxicity studies in rats and rabbits or the 2-generation
reproduction toxicity study in rats. In a developmental toxicity study
in rats, no developmental toxicity was observed in the fetuses at the
highest dose tested. Transient decreases in body weight gain and food
consumption were noted in the dams in this study. In a developmental
toxicity study in rabbits, an increased incidence of abortions was
observed. The does which aborted had markedly decreased body weight,
body weight gain and food consumption. There was also an equivocal
increase in percent postimplantation loss and mean number of
resorptions per doe in this study. In the reproduction toxicity study
in rats, offspring toxicity (decreased body weights for F1 and F2 pups
throughout lactation) was noted at a dose that also resulted in
parental toxicity (decreased body weight, body weight gain, and food
consumption; and hepatotoxicity). No reproductive toxicity was observed
in this study at the highest dose tested.
    In an acute neurotoxicity study in rats, there was equivocal
evidence of a possible slight neurotoxic effect at the limit dose. In
this study, an increased incidence of palpebral (eyelid) closure was
observed, but only in males and only on day one. Other than this
equivocal evidence and the clinical observations in the 13-week feeding
study in dogs of myotonic twitching in the high dose male and female
animals, there was no evidence of treatment-related neurotoxicity in
the toxicity studies on famoxadone, including a subchronic
neurotoxicity study in rats.
    In 28-day immunotoxicity studies in rats and mice, there was no
evidence of immunotoxicity following exposure to famoxadone.
    In carcinogenicity studies in male and female rats and mice,
famoxadone did not demonstrate any biologically significant evidence of
carcinogenic potential. Famoxadone is classified as ``not likely to be
carcinogenic to humans.''
     Specific information on the studies received and the nature of the
adverse effects caused by famoxadone as well as the no-observed-
adverse-effect-level and the lowest-observed-adverse-effect-level from
the toxicity studies can be found at http://www.regulations.gov in the
document Famoxadone. Human Health Risk Assessment for the Proposed Food
Use of Famoxadone on Bulb Vegetables, Crop Group 3; Leafy Greens,
Subgroup 4A; Leaf Petioles, Subgroup 4B; and Cilantro at page 54 in
docket ID number EPA-HQ-OPP-2007-1192.

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-term,
intermediate-term, 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 famoxadone used for
human risk assessment can be found at http://www.regulations.gov in the
document Famoxadone. Human Health Risk Assessment for the Proposed Food

Use of Famoxadone on Bulb Vegetables, Crop Group 3; Leafy Greens,
Subgroup 4A; Leaf Petioles, Subgroup 4B; and Cilantro at page 31 in
docket ID number EPA-HQ-OPP-2007-1192.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to famoxadone, EPA considered exposure under the petitioned-
for tolerances as well as all existing famoxadone tolerances in 40 CFR
180.587. EPA assessed dietary exposures from famoxadone 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 famoxadone; therefore, a
quantitative acute dietary exposure assessment is unnecessary.
    ii. Chronic exposure. In conducting the chronic dietary exposure
assessment EPA used the food consumption data from the U.S. Department
of Agriculture (USDA) 1994-1996, and 1998 Continuing Surveys of Food
Intakes by Individuals (CSFII). As to residue levels in food, EPA used
average residues from field trials for most plant commodities and
anticipated residues based on the anticipated dietary burdens of
livestock for animal commodities. Empirical processing factors were
used to refine the residue estimates of processed tomato, pepper,
potato and grape commodities. For leafy vegetables, empirically-derived
reduction factors were applied to account for reduction of residues
from washing and removal of outer leaves. Percent crop treated (PCT)
and projected PCT estimates were used to further refine exposure
estimates for many of the existing and new uses of famoxadone.
    iii. Cancer. Based on the results of carcinogenicity studies in
rats and mice, EPA classified famoxadone as ``not likely to be
carcinogenic to humans;'' therefore, an exposure assessment for
evaluating cancer risk is not needed for this chemical.
    iv. Anticipated residue and percent crop treated (PCT) information.
Section 408(b)(2)(E) of FFDCA authorizes EPA to use available data and
information on the anticipated residue levels of pesticide residues in
food and the actual levels of pesticide residues that have been
measured in food. If EPA relies on such information, EPA must require
pursuant to FFDCA section 408(f)(1) that data be provided 5 years after
the tolerance is established, modified, or left in effect,
demonstrating that the levels in food are not above the levels
anticipated. For the present action, EPA will issue such Data Call-Ins
as are required by FFDCA section 408(b)(2)(E) and authorized under
FFDCA section 408(f)(1). Data will be required to be submitted no later
than 5 years from the date of issuance of these tolerances.
    Section 408(b)(2)(F) of FFDCA states that the Agency may use data
on the actual percent of food treated for assessing chronic dietary
risk only if:
     Condition a: The data used are reliable and provide a
valid basis to show what percentage of the food derived from such crop
is likely to contain the pesticide residue.
     Condition b: The exposure estimate does not underestimate
exposure for any significant subpopulation group.
     Condition c: Data are available on pesticide use and food
consumption in a particular area, the exposure estimate does not
understate exposure for the population in such area.
In addition, the Agency must provide for periodic evaluation of any
estimates used. To provide for the periodic evaluation of the estimate
of PCT as required by FFDCA section 408(b)(2)(F), EPA may require
registrants to submit data on PCT.
    The Agency used PCT information as follows:
    Cucumbers 5%, peppers 5%, potatoes 5%, pumpkins 5%, squash 1%,
tomatoes 10% and watermelons 1%.
    In most cases, EPA uses available data from U.S. Department of
Agriculture/National Agricultural Statistics Service (USDA/NASS),
proprietary market surveys, and the National Pesticide Use Database for
the chemical/crop combination for the most recent 6 years. EPA uses an
average PCT for chronic dietary risk analysis. The average PCT figure
for each existing use is derived by combining available public and
private market survey data for that use, averaging across all
observations, and rounding to the nearest 5%, except for those
situations in which the average PCT is less than one. In those cases,
1% is used as the average PCT and 2.5% is used as the maximum PCT. EPA
uses a maximum PCT for acute dietary risk analysis. The maximum PCT
figure is the highest observed maximum value reported within the recent
6 years of available public and private market survey data for the
existing use and rounded up to the nearest multiple of 5%.
    The Agency used projected percent crop treated (PPCT) information
for certain new crops (celery, lettuce, and spinach) as well as the
currently registered crop, grapes. Since famoxadone has only been
registered on grapes for 1 year, PCT estimates based on actual usage
data were not deemed sufficient indicators of potential usage on
grapes. The following PPCT estimates were used in the chronic dietary
exposure assessment: Celery 39%, grapes (wine and table) 5%, grape
(juice) 50%, lettuce (head) 67%, lettuce (other) 62%, and spinach 39%.
    EPA estimates PPCT for a new pesticide use by assuming that the
percent crop treated (PCT) during the pesticide's initial 5 years of
use on a specific use site will not exceed the average PCT of the
dominant pesticide (i.e., the one with the greatest PCT) on that site
over the three most recent surveys. Comparisons are only made among
pesticides of the same pesticide type (i.e., the dominant fungicide on
the use site is selected for comparison with a new fungicide). The PCTs
included in the average may be each for the same pesticide or for
different pesticides since the same or different pesticides may
dominate for each year selected. Typically, EPA uses USDA/NASS data as
the source for raw PCT data because it is publicly available and does
not have to be calculated from other available data. When a specific
use site is not surveyed by USDA/NASS, EPA uses proprietary data and
calculates the estimated PCT.
    This estimated PPCT, based on the average PCT of the market leader,
is appropriate for use in the chronic dietary risk assessment. This
method of estimating a PPCT for a new use of a registered pesticide or
a new pesticide produces a high-end estimate that is unlikely, in most
cases, to be exceeded during the initial 5 years of actual use.
    The predominant factors that bear on whether the estimated PPCT
could be exceeded are whether the new pesticide use is more efficacious
or controls a broader spectrum of pests than the dominant pesticide(s),
whether there are concerns with pest pressures as indicated in
emergency exemption requests (http://www.epa.gov/opprd001/section18/)
or other readily available information, and/or other factors based on
analysis of additional information. All information readily available
has been considered for famoxadone on celery, lettuce and spinach, and
it is the opinion of EPA that it is unlikely that actual PCTs for
famoxadone on these sites will exceed the corresponding estimated PPCTs
during the next 5 years.
     A discussion of the factors considered in making this
determination can be found in the document PPCT for the Use of
Fungicide Famoxadone (PC 113202)

on celery (DP 357845), lettuce and spinach (DP 357847), and grapes (no
BEAN). Additional Factors Revised in this Memorandum. The referenced
document is available at www.regulations.gov in docket ID number EPA-
HQ-OPP-2007-1192.
    The Agency believes that the three conditions discussed in Unit
III.C.1.iv. have been met. With respect to Condition a, PCT estimates
are derived from Federal and private market survey data, which are
reliable and have a valid basis. The Agency is reasonably certain that
the percentage of the food treated is not likely to be an
underestimation. As to Conditions b and c, regional consumption
information and consumption information for significant subpopulations
is taken into account through EPA's computer-based model for evaluating
the exposure of significant subpopulations including several regional
groups. Use of this consumption information in EPA's risk assessment
process ensures that EPA's exposure estimate does not understate
exposure for any significant subpopulation group and allows the Agency
to be reasonably certain that no regional population is exposed to
residue levels higher than those estimated by the Agency. Other than
the data available through national food consumption surveys, EPA does
not have available reliable information on the regional consumption of
food to which famoxadone may be applied in a particular area.
    2. Dietary exposure from drinking water. The Agency used screening
level water exposure models in the dietary exposure analysis and risk
assessment for famoxadone in drinking water. These simulation models
take into account data on the physical, chemical, and fate/transport
characteristics of famoxadone. 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 Pesticide Root Zone Model/Exposure Analysis Modeling
System (PRZM/EXAMS) and Screening Concentration in Ground Water (SCI-
GROW) models, the estimated drinking water concentrations (EDWCs) of
famoxadone for acute exposures are estimated to be 6.2 parts per
billion (ppb) for surface water and 0.01 ppb for ground water. EDWCs of
famoxadone for chronic exposures for non-cancer assessments are
estimated to be 0.189 ppb for surface water and 0.01 ppb for ground
water.
    Modeled estimates of drinking water concentrations were directly
entered into the dietary exposure model. For chronic dietary risk
assessment, the water concentration of value 0.189 ppb was used to
assess the contribution to drinking water. As explained in Unit
III.C.1.i. an acute dietary risk assessment for famoxadone is
unnecessary.
    3. From non-dietary exposure. The term ``residential exposure'' is
used in this document to refer to non-occupational, non-dietary
exposure (e.g., for lawn and garden pest control, indoor pest control,
termiticides, and flea and tick control on pets). Famoxadone is not
registered for any specific use patterns that would result in
residential exposure.
    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 famoxadone to share a common mechanism of
toxicity with any other substances, and famoxadone does not appear to
produce a toxic metabolite produced by other substances. For the
purposes of this tolerance action, therefore, EPA has assumed that
famoxadone 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 safety
factor (SF). In applying this provision, EPA either retains the default
value of 10X, or uses a different additional safety factor when
reliable data available to EPA support the choice of a different
factor.
    2. Prenatal and postnatal sensitivity. The prenatal and postnatal
toxicity database for famoxadone includes rat and rabbit developmental
toxicity studies and a 2-generation reproduction toxicity study in
rats. There was no evidence of increased quantitative or qualitative
susceptibility of in utero rats or rabbits in the developmental
toxicity studies or of offspring in the rat reproduction study.
    3. Conclusion. EPA has determined that the FQPA safety factor of
10X must be retained as a database uncertainty factor for the chronic
dietary exposure assessment. That decision is based on the following
findings:
    i. Although the toxicity database for famoxadone is complete, there
is uncertainty related to the 13-week feeding study in dogs that was
selected to assess chronic dietary exposures to famoxadone. EPA has
determined that the 10X FQPA safety factor must be retained to account
for the uncertainty arising due to the lack of a NOAEL in this study
and extrapolation from a subchronic to chronic exposure duration. A 10X
uncertainty factor is considered to provide an adequate margin of
safety during development, based on several considerations. First, the
LOAEL appeared to be a threshold effect level based on the minimal
findings observed. The endpoint (microscopic lens lesions, cataracts,
in the eyes of female dogs) was of minimal severity at the lowest dose
tested (1.4 milligrams/kilogram/day (mg/kg/day)). This finding would
probably have very little effect on vision, and no evidence of
cataracts was observed in the ophthalmologic examination. Second,
although the microscopic data in the chronic dog study were not
considered acceptable due to fixation artifact, there was no evidence
of cataracts in the ophthalmologic examination at a similar dose (1.2
mg/kg/day), suggesting that progression with time was minimal at that
dose. Finally, there was no evidence of cataracts in monkeys
administered famoxadone for 1-year at doses up to 1,000 mg/kg/day. The
lack of cataracts in a primate species provides suggestive evidence
that humans may be less sensitive than dogs for this effect.
    ii. There was equivocal evidence of a slight neurotoxic effect
(eyelid closure) at the limit dose in the acute neurotoxicity study in
rats, and myotonic twitching was noted at the high dose in male and
female dogs in the 13-week feeding study. In this same study, one
female dog in the high dose group also had convulsions and ataxia on
day 34. Since there was no evidence of treatment-related neurotoxicity
at lower doses in these studies or in any other famoxadone toxicity
studies, including a subchronic neurotoxicity study in rats and the 1-
year feeding study in dogs, EPA has concluded that

there is not a concern for neurotoxicity from exposure to famoxadone,
and there is no need for a developmental neurotoxicity study or
additional UFs to account for neurotoxicity.
    iii. There is no evidence that famoxadone results in increased
susceptibility in in utero rats or rabbits in the prenatal
developmental studies or in young rats in the 2-generation reproduction
study.
    iv. There are no residual uncertainties identified in the exposure
databases. The dietary food exposure assessments were refined for most
commodities using reliable PCT/PPCT information and anticipated residue
values calculated from valid field trial data. EPA made conservative
(protective) assumptions in the ground and surface water modeling used
to assess exposure to famoxadone in drinking water. Residential
exposure to famoxadone is not expected. These assessments will not
underestimate the exposure and risks posed by famoxadone.

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-term, intermediate-term, 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,
famoxadone 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
famoxadone from food and water will utilize 65% of the cPAD for adult
males, 20 years and older, the population group receiving the greatest
exposure. There are no residential uses for famoxadone.
    3. Short-term risk. Short-term aggregate exposure takes into
account short-term residential exposure plus chronic exposure to food
and water (considered to be a background exposure level). Famoxadone is
not registered for any use patterns that would result in residential
exposure. Therefore, the short-term aggregate risk is the sum of the
risk from exposure to famoxadone through food and water and will not be
greater than the chronic aggregate risk.
    4. Intermediate-term risk. Intermediate-term aggregate exposure
takes into account intermediate-term residential exposure plus chronic
exposure to food and water (considered to be a background exposure
level). Famoxadone is not registered for any use patterns that would
result in intermediate-term residential exposure. Therefore, the
intermediate-term aggregate risk is the sum of the risk from exposure
to famoxadone through food and water, which has already been addressed,
and will not be greater than the chronic aggregate risk.
    5. Aggregate cancer risk for U.S. population. Famoxadone is
classified as ``not likely to be carcinogenic to humans'' and is,
therefore, not expected to pose a cancer risk.
    6. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
to the general population, or to infants and children from aggregate
exposure to famoxadone residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (Gas Chromatography with Nitrogen
Phosphorus Detection (GC/NPD)) is available to enforce the tolerance
expression. The method may be requested from: Chief, Analytical
Chemistry Branch, Environmental Science Center, 701 Mapes Rd., Ft.
Meade, MD 20755-5350; telephone number:<PHONE_NUMBER>; e-mail address:
<EMAIL_ADDRESS>
B. International Residue Limits

    There are no CODEX maximum residue limits (MRLS) established for
famoxadone on the commodities associated with these petitions.

C. Response to Comments

    Comments were received from a private citizen objecting to EPA's
reliance on animal toxicity testing on the basis that it is inhumane
and not indicative of the potential for pesticides to cause toxicity in
humans. The Agency disagrees with the commenter's claims regarding
animal testing. Since humans and animals have complex organ systems and
mechanisms for the distribution of chemicals in the body, as well as
processes for eliminating toxic substances from their systems, EPA
relies on laboratory animals such as rats and mice to mimic the
complexity of human and higher-order animal physiological responses
when exposed to a pesticide. EPA is committed, however, to reducing the
use of animals whenever possible. EPA-required studies include animals
only when the requirements of sound toxicological science make the use
of an animal absolutely necessary. The Agency's goal is to be able to
predict the potential of pesticides to cause harmful effects to humans
and wildlife by using fewer laboratory animals as models and EPA has
been accepting data from alternative (to animals) test methods for
several years. As progress is made on finding or developing non-animal
test models that reliably predict the potential for harm to humans or
the environment, EPA expects that it will need fewer animal studies to
make safety determinations. Finally, because the commenter has not
provided the Agency with a specific rationale (including supporting
information) as to why the Agency's action is inconsistent with the
legal standards in section 408 of FFDCA, EPA can not provide any more
detailed response to the commenter's disagreement with the Agency's
decision.

D. Revisions to Petitioned-For Tolerances

    IR-4 proposed a tolerance of 40 ppm on the crop group ``vegetable,
bulb, group 3.'' Based on the results of field trials showing a greater
than 5-fold difference in residues on bulb and green onions, EPA
determined that separate tolerances are required for these subgroups.
Therefore, EPA is establishing tolerances of 0.45 ppm on onion, bulb,
subgroup 3-07A and 40 ppm on onion, green, subgroup 3-07B. EPA
determined the appropriate tolerance levels for bulb and green onions
based on analyses of the residue field trial data using the Agency's
Tolerance Spreadsheet in accordance with the Agency's Guidance for
Setting Pesticide Tolerances Based on Field Trial Data.
    IR-4 proposed tolerances on leaf petioles, subgroup 4B at 25 ppm
and on leafy greens, subgroup 4A and cilantro, leaves at 50 ppm. Based
on the results of field trial data indicating higher residues in
spinach than the other members of subgroup 4A, EPA determined that a
tolerance of 25 ppm would be adequate for members of the entire crop
group 4 (including

subgroups 4A and 4B), except spinach, and cilantro leaves. Therefore,
EPA is establishing tolerances of 25 ppm on vegetable, leafy, except
Brassica, group 4, except spinach; 25 ppm on cilantro, leaves; and 50
ppm on spinach.

V. Conclusion

    Therefore, tolerances are established for residues of famoxadone,
3-anilino-5-methyl-5-(4-phenoxyphenyl)-1,3-oxazolidine-2,4-dione, in or
on caneberry subgroup 13-07A at 10 ppm; cilantro, leaves at 25.0 ppm;
onion, bulb, subgroup 3-07A at 0.45 ppm; onion, green, subgroup 3-07B
at 40 ppm; spinach at 50 ppm; and vegetable, leafy, except Brassica,
group 4, except spinach at 25 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 tolerances 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: February 12, 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 180.587 is amended by removing the tolerances for Caneberry,
Subgroup 13A and Lettuce, head; and alphabetically adding the following
commodities to the table in paragraph (a) to read as follows:

Sec.  180.587  Famoxadone; tolerances for residues.

    (a) * * *

------------------------------------------------------------------------
                   Commodity                        Parts per million
------------------------------------------------------------------------
Caneberry subgroup 13-07A......................                       10
                                * * * * *
Cilantro, leaves...............................                       25
                                * * * * *
Onion, bulb, subgroup 3-07A....................                     0.45
Onion, green, subgroup 3-07B...................                       40
                                * * * * *
Spinach........................................                       50
                                * * * * *
Vegetable, leafy, except Brassica, group 4,                           25
 except spinach................................
------------------------------------------------------------------------

* * * * *
[FR Doc. E9-4357 Filed 3-3-09; 8:45 am]

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