[Federal Register Volume 78, Number 124 (Thursday, June 27, 2013)]
[Notices]
[Pages 38764-38765]
[FR Doc No: 2013-15368]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-69819; File No. SR-NYSE-2013-44]

Self-Regulatory Organizations; New York Stock Exchange LLC;
Notice of Filing and Immediate Effectiveness of Proposed Rule Change
Extending the Operation of Its Supplemental Liquidity Providers Pilot,
Until the Earlier of the Securities and Exchange Commission's Approval
To Make Such Pilot Permanent or January 31, 2014

June 21, 2013.
    Pursuant to Section 19(b)(1) \1\ of the Securities Exchange Act of
1934 (the ``Act'') \2\ and Rule 19b-4 thereunder,\3\ notice is hereby
given that on June 17, 2013, New York Stock Exchange LLC (``NYSE'' or
``Exchange'') filed with the Securities and Exchange Commission
(``Commission'') the proposed rule change as described in Items I and
II below, which Items have been prepared by the Exchange. 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 proposes to [sic] extend the operation of
its Supplemental Liquidity Providers Pilot (``SLP Pilot'' or ``Pilot'')
(See Rule 107B), currently scheduled to expire on July 31, 2013, until
the earlier of the Securities and Exchange Commission's
(``Commission'') approval to make such Pilot permanent or January 31,
2014. The text of 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
Statutory Basis for, the Proposed Rule Change

1. Purpose
    The Exchange proposes to extend the operation of its SLP Pilot,\4\
currently scheduled to expire on July 31, 2013, until the earlier of
Commission approval to make such Pilot permanent or January 31, 2014.
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    \4\ See Securities Exchange Act Release No. 58877 (October 29,
2008), 73 FR 65904 (November 5, 2008) (SR-NYSE-2008-108)
(establishing the SLP Pilot). See also Securities Exchange Act
Release Nos. 59869 (May 6, 2009), 74 FR 22796 (May 14, 2009) (SR-
NYSE-2009-46) (extending the operation of the SLP Pilot to October
1, 2009); 60756 (October 1, 2009), 74 FR 51628 (October 7, 2009)
(SR-NYSE-2009-100) (extending the operation of the NMM and the SLP
Pilots to November 30, 2009); 61075 (November 30, 2009), 74 FR 64112
(December 7, 2009) (SR-NYSE-2009-119) (extending the operation of
the SLP Pilot to March 30, 2010); 61840 (April 5, 2010), 75 FR 18563
(April 12, 2010) (SR-NYSE-2010-28) (extending the operation of the
SLP Pilot to September 30, 2010); 62813 (September 1, 2010), 75 FR
54686 (September 8, 2010) (SR-NYSE-2010-62) (extending the operation
of the SLP Pilot to January 31, 2011); 63616 (December 29, 2010), 76
FR 612 (January 5, 2011) (SR-NYSE-2010-86) (extending the operation
of the SLP Pilot to August 1, 2011); 64762 (June 28, 2011), 76 FR
39145 (July 5, 2011) (SR-NYSE-2011-30) (extending the operation of
the SLP Pilot to January 31, 2012); 66045 (December 23, 2011), 76 FR
82342 (December 30, 2011) (SR-NYSE-2011-66) (extending the operation
of the SLP Pilot to July 31, 2012); 67493 (July 25, 2012), 77 FR
45388 (July 31, 2012) (SR-NYSE-2012-27) (extending the operation of
the SLP Pilot to January 31, 2013); and 68560 (January 2, 2013), 78
FR 1280 (January 8, 2013) (SR-NYSE-2012-76) (extending the operation
of the SLP Pilot to July 31, 2013).
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Background \5\
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    \5\ The information contained herein is a summary of the NMM
Pilot and the SLP Pilot. See supra note 4 for a fuller description
of those pilots.
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    In October 2008, the NYSE implemented significant changes to its
market rules, execution technology and the rights and obligations of
its market participants all of which were designed to improve execution
quality on the Exchange. These changes are all elements of the
Exchange's enhanced market model referred to as the ``New Market
Model'' (``NMM Pilot'').\6\ The SLP Pilot was launched in coordination
with the NMM Pilot (see Rule 107B).
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    \6\ See Securities Exchange Act Release No. 58845 (October 24,
2008), 73 FR 64379 (October 29, 2008) (SR-NYSE-2008-46).
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    As part of the NMM Pilot, NYSE eliminated the function of
specialists on the Exchange creating a new category of market
participant, the Designated Market Maker or DMM.\7\ Separately, the
NYSE established the SLP Pilot, which established SLPs as a new class
of market participants to supplement the liquidity provided by DMMs.\8\
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    \7\ See NYSE Rule 103.
    \8\ See NYSE Rule 107B. The Exchange amended the monthly volume
requirements to an ADV that is a specified percentage of NYSE CADV.
See Securities Exchange Act Release No. 67759 (August 30, 2012), 77
FR 54939 (September 6, 2012) (SR-NYSE-2012-38).
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    The SLP Pilot is scheduled to end operation on July 31, 2013 or
such earlier time as the Commission may determine to make the rules
permanent. The Exchange is currently preparing a rule filing seeking
permission to make the SLP Pilot permanent, but does not expect that
filing to be completed and approved by the Commission before July 31,
2013.\9\
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    \9\ The NMM Pilot was scheduled to expire on July 31, 2013. On
June 14, 2013 the Exchange filed to extend the NMM Pilot until
January 31, 2014. See (SR-NYSE-2013-42). See also Securities
Exchange Act Release Nos. 78 FR 1288 (January 8, 2013) (SR-NYSE-
2012-75) (extending the operation of the NMM Pilot to July 31,
2013), 67494 (July 25, 2012), 77 FR 45408 (July 31, 2012) (SR-NYSE-
2012-26) (extending the operation of the NMM Pilot to January 31,
2013); 66046 (December 23, 2011), 76 FR 82340 (December 30, 2011)
(SR-NYSE-2011-65) (extending the operation of the NMM Pilot to July
31, 2012); 64761 (June 28, 2011) 76 FR 39147 (July 5, 2011) (SR-
NYSE-2011-29) (extending the operation of the NMM Pilot to January
31, 2012); 63618 (December 29, 2010) 76 FR 617 (January 5, 2011)
(SR-NYSE-2010-85) (extending the operation of the NMM Pilot to
August 1, 2011); 62819 (September 1, 2010), 75 FR 54937 (September
9, 2010) (SR-NYSE-2010-61) (extending the operation of the NMM Pilot
to January 31, 2011); 61724 (March 17, 2010), 75 FR 14221 (SR-NYSE-
2010-25) (extending the operation of the NMM Pilot to September 30,
2010); and 61031 (November 19, 2009), 74 FR 62368 (SR-NYSE-2009-113)
(extending the operation of the NMM Pilot to March 30, 2010).
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Proposal To Extend the Operation of the SLP Pilot
    The NYSE established the SLP Pilot to provide incentives for
quoting, to enhance competition among the existing group of liquidity
providers, including the DMMs, and add new competitive market
participants. The Exchange believes that the SLP Pilot, in

coordination with the NMM Pilot, allows the Exchange to provide its
market participants with a trading venue that utilizes an enhanced
market structure to encourage the addition of liquidity, facilitate the
trading of larger orders more efficiently and operates to reward
aggressive liquidity providers. As such, the Exchange believes that the
rules governing the SLP Pilot (Rule 107B) should be made permanent.
Through this filing the Exchange seeks to extend the current operation
of the SLP Pilot until January 31, 2014, in order to allow the Exchange
to formally submit a filing to the Commission to convert the Pilot rule
to a permanent rule.\10\
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    \10\ The NYSE MKT SLP Pilot (NYSE MKT Rule 107B--Equities) is
also being extended until January 31, 2014 or until the Commission
approves it as permanent (See SR-NYSEMKT-2013-52).
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2. Statutory Basis
    The basis under the Securities Exchange Act of 1934 (the ``Act'')
for this proposed rule change is the requirement under Section 6(b)(5)
that an exchange have rules that are designed to promote just and
equitable principles of trade, 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 the instant filing is consistent with these principles
because the SLP Pilot provides its market participants with a trading
venue that utilizes an enhanced market structure to encourage the
addition of liquidity and operates to reward aggressive liquidity
providers. Moreover, the instant filing requesting an extension of the
SLP Pilot will permit adequate time for: (i) the Exchange to prepare
and submit a filing to make the rules governing the SLP Pilot
permanent; (ii) public notice and comment; and (iii) completion of the
19b-4 approval process.

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 that is not necessary or appropriate
in furtherance of the purposes of the Act. The Exchange believes that
extending the operation of the SLP Pilot will enhance competition among
liquidity providers and thereby improve execution quality on the
Exchange.

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 \11\ and Rule 19b-4(f)(6) thereunder.\12\
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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    \11\ 15 U.S.C. 78s(b)(3)(A)(iii).
    \12\ 17 CFR 240.19b-4(f)(6). In addition, Rule 19b-4(f)(6)
requires the Exchange to give the Commission written notice of the
Exchange's intent to file the proposed rule change, along with a
brief description and text of the proposed rule change, at least
five business days prior to the date of filing of the proposed rule
change, or such shorter time as designated by the Commission. The
Exchange has satisfied this requirement.
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    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.

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-NYSE-2013-44 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-NYSE-2013-44. 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 such filing also will be available
for inspection and copying at the principal office of the Exchange. All
comments received will be posted without change; the Commission does
not edit personal identifying information from submissions. You should
submit only information that you wish to make publicly available. All
submissions should refer to File Number SR-NYSE-2013-44 and should be
submitted on or before July 18, 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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Jill M. Peterson,
Assistant Secretary.
[FR Doc. 2013-15368 Filed 6-26-13; 8:45 am]
BILLING CODE 8011-01-P


  SEQ CHAPTER \h \r 1

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, D.C.  20460

                                                                                OFFICE OF

PREVENTION, PESTICIDES

AND TOXIC SUBSTANCES

MEMORANDUM

DATE:   	6-Apr-07

SUBJECT:	Cymoxanil: Revised Chronic Aggregate Dietary (Food and Drinking Water) Exposure Assessment for the Proposed IR-4 Uses on Grapes, Hops (PP # 5E7000) and Caneberries (PP # 6E7100).

PC Code:	129106			Decision Number: 361987

DP Num: 	338733

REVIEWER:	Susan L. Stanton, Environmental Scientist

		Reregistration Branch III

		Health Effects Division (7509P)

THROUGH:	Amelia Acierto, Chemist

		Thurston Morton, Chemist

Dietary Exposure Science Advisory Council (DESAC)

Health Effects Division (7509P); and

Danette Drew, Senior Scientist

Reregistration Branch III

Health Effects Division (7509P)

TO:		Shaja Brothers

		Risk Integration, Minor Use and Emergency Response Branch

Registration Division (7505P)

On December 5, 2006, the Registration Division ARIA team completed acute and chronic aggregate dietary risk assessments to support proposed new uses of cymoxanil on grapes, hops and caneberries (Eugenia McAndrew; DP Num: 333189; 12/05/06).  The acute assessment was an unrefined, tier 1 assessment.  The partially refined chronic assessment was conducted using average field trial residues for lettuce and tolerance level residues for all other commodities.  Chronic exposure estimates were further refined using screening-level percent crop treated (%CT) data for several registered commodities and projected %CT data for grapes.  Concerns have been raised by the Office of General Council regarding the projected %CT estimate for grapes.  To alleviate these concerns, the chronic dietary risk assessment has been revised.  In the revised assessment, the exposure estimates for grapes are based on average field trial residues with no further adjustment for percent crop treated.  Processing factors of 1.4x and 1x are applied to grape juice and raisins, based on the results of a grape processing study.  Average field trial residues are also being used for hops in the revised assessment.  No other changes have been made.  Only the revised chronic dietary risk assessment for cymoxanil is presented in this memorandum.  The acute dietary risk assessment described in the Debember, 2006 memorandum remains valid.

Executive Summary

M-FCID™), Version 2.03, which uses food consumption data from the U.S. Department of Agriculture’s Continuing Surveys of  Food Intakes by Individuals (CSFII) from 1994-1996 and 1998.  The analysis was performed to support the proposed IR-4 tolerance petitions for the use of cymoxanil on grapes, hops and caneberries.

The partially refined chronic analysis was conducted for the general U.S. population and all population subgroups using tolerance level residues for all commodities except lettuce, hops and grapes.  Average residues from field trials were used for lettuce, hops and grapes.  DEEM default processing factors were used for all commodities except grapes.  Processing factors for grape juice (1.4x) and raisins (1x) were derived from grape processing data.  Exposure estimates were further refined using screening-level percent crop treated (% CT) data for several registered commodities.  For all other commodities, including the proposed new uses, 100%CT was assumed.

Drinking water was incorporated directly into the dietary assessment using the chronic estimated drinking water concentration of 0.0001 ppm generated using the FIRST (version 1.0) model for surface water.

Chronic Dietary Exposure Results

Chronic dietary exposure estimates for food and drinking water combined are below HED’s level of concern.  Using the DEEM-FCID™ software, dietary exposure is estimated at 0.000271 mg/kg/day for the general U.S. population (34% of the chronic Population Adjusted Dose (cPAD)) and 0.000405 mg/kg/day (51% of the cPAD) for children 1 to 2 years old, the population subgroup with the highest estimated chronic dietary exposure to cymoxanil.

I.	Introduction

Dietary risk assessment incorporates both exposure and toxicity of a given pesticide.  For acute and chronic assessments, the risk is expressed as a percentage of a maximum acceptable dose (i.e., the dose which HED has concluded will result in no unreasonable adverse health effects).  This dose is referred to as the population adjusted dose (PAD).  The PAD is equivalent to the point of departure (POD; e.g., NOAEL, LOAEL) divided by the appropriate uncertainty or safety factors.

For non-cancer chronic exposures, HED is concerned when estimated dietary risk exceeds 100% of the PAD.  References which discuss the chronic risk assessment in more detail are available on the EPA/pesticides web site:  “Available Information on Assessing Exposure from Pesticides, A User’s Guide,” 6/21/2000, web link:      HYPERLINK "http://www.epa.gov/fedrgstr/EPA-PEST/2000/July/Day-12/6061.pdf"  http://www.epa.gov/fedrgstr/EPA-PEST/2000/July/Day-12/6061.pdf  ; or see SOP 99.6 (8/20/99).

The most recent HED dietary risk assessment for cymoxanil (S. Levy, DP Num: 276292, 04/DEC/2002) was conducted to support the FIFRA §3 food uses on hops, lychee, fruiting vegetables, head lettuce and cucurbits.

Food Residue Information

A. Tolerance Expression and Residues of Concern for the Registered/Proposed Crops

An ad hoc MARC met on 21/JAN/1998 and decided that parent only is of regulatory concern (G. Kramer, et. al., DP Num: 242321, 26/JAN/1998) in tomatoes, potatoes, grapes, livestock, rotational crops and drinking water.  Subsequent to the initial MARC meeting, the petitioner submitted a lettuce metabolism study (MRID 44944605).  Metabolites IN-KQ960 and IN-KP533 are present in the lettuce metabolism study which were not present in the tomato, grape, potato or rat metabolism studies.  The lettuce metabolism results were presented to the HED MARC to assess the toxicological significance of these metabolites and to determine which additional residues, if any, to regulate in lettuce.

The MARC concluded (S. Levy, DP Num: 276796, 30/AUG/2001) that for the tolerance expression the residue of concern in/on hops is cymoxanil per se.  For risk assessment purposes for hops and lettuce, the metabolite IN-KQ960 must be included, along with the parent, based on the ratio of IN-KQ960 to the parent in the lettuce 14C metabolism study.  For any future petitions for tolerance on leafy vegetables, the petitioner was instructed to include residue data for IN-KQ960.  The final decision concerning the tolerance expression in lettuce and other leafy vegetables is deferred pending results of the residue studies.

Tolerances are currently established under 40 CFR 180.503 for grape (0.1 ppm, imports only), hop, dried cones (1.0 ppm), lettuce, head (4.0 ppm), lychee (1.0 ppm), potato, (0.05 ppm), vegetable, cucurbit, group 9 (0.05 ppm) and vegetable, fruiting, group 8 (0.2 ppm).  IR-4 has proposed adding caneberries (4 ppm) and increasing the grape tolerance to 1 ppm and the dried hop tolerance to 5 ppm.  The increased tolerance for grapes is being requested to support domestic use of cymoxanil on grapes.  The increased tolerance for dried hop is being requested to support a different formulation which results in higher field trial residues.  RD’s ARIA team has reviewed the residue chemistry data associated with the current request.  These data do not support increasing the tolerance for grapes from 0.1 to 1.0 ppm.  The data indicate that the tolerance for hop should be increased from 1.0 to 7.0 ppm.  ARIA concludes that the following tolerances for residues of cymoxanil are appropriate (D. Rate; DP Num: 324447; 02/06/07):

Grape 			0.1 ppm

Hop, dried cones	7.0 ppm

Caneberries		4.0 ppm

There are no livestock feedstuffs associated with the proposed uses on grapes, hops and caneberries; therefore, tolerances for livestock commodities are not required.

B. Residue Data used in the Chronic Dietary Analysis

The partially refined chronic analysis was conducted using tolerance level residues for all commodities except lettuce, hops and grapes.  Average residues from field trials conducted at maximum application rates were used for lettuce (MRID 44946430; S. Levy, 11/20/02) and hops (MRID 44670201; D. Rate; 11/06/06).  Separate field trials were conducted to support the existing import tolerance on grapes and the proposed domestic use on grapes.  Slightly higher residues were found in the imported grape field trials, most likely due to the shorter PHI in the imported trials (14 vs. 28 days).  A conservative anticipated residue for grapes was calculated by taking the average of grape residues from the imported grape field trials (MRID 43616533; G. Kramer; 04/25/1996), incorporating ½ the Limit of Detection for non-detectable residues.  This value was used for all grapes in the chronic assessment, including domestically grown grapes.

Exposure estimates were further refined based on screening-level percent crop treated (% CT) data provided by BEAD for cucumbers, lettuce, peppers, potatoes, pumpkins, squash, tomatoes and watermelons [Cymoxanil Screening- level Usage Analysis (SLUA),  J. Carter, 11/02/06].  For all other registered and proposed commodities, 100%CT was assumed.

DEEM ver. 7.81 default processing factors were used for all processed food commodities except grape juice and raisins.  A concentration factor of 1.4x was applied to grape juice based on the results of the grape processing study (MRID 43616534; G. Kramer; 04/25/96).  The processing factor for raisins was set to 1x based on the results of this same study.

The residue data, %CT estimates and processing factors used in the chronic assessment are summarized in Table 1.

Table # 1.  Residue Data used in the Chronic Dietary Analysis for Cymoxanil

Commodity	Residue	Percent Crop Treated	Processing Factors

Grape	0.0285 ppm

(average field trial)	             100	Juice (1.4x)

Raisins (1x)

MRID 43616534

Hop, dried cones1	9.4 ppm

(average field trial  + metabolite)	            100	1x

Lettuce, head2	 3.15 ppm

(average field trial + metabolite)	              10	1x

Lychee	 1.0   ppm (tolerance)	             100	Dried  1.85

Potato	 0.05 ppm (tolerance)	               10	Dried  6.5

Cucurbit Vegetables (Group 9)	 0.05 ppm (tolerance)	Cucumber       10

Pumpkin           1

Squash              1

Watermelon      1

All others      100	1x

Fruiting vegetables

(Group 8)	 0.2  ppm (tolerance)	Tomatoes        10

Peppers           10

All others      100

	Tomato paste  5.4

Tomato puree 3.3

Tomato dried 14.3

Tomato juice  1.5

Caneberries

(Subgroup 13A)	  4.0 ppm (tolerance)	              100	1x

1 Average residue from imported hop field trials + (3.5 x average FT residue) = 2.09 ppm + ( 3.5 x 2.09) = 9.4 ppm

2 Average FT + (3.5 x Average FT) = 0.7 ppm + (3.5 x 0.7 ppm) = 3.15 ppm

 Drinking Water Data

References: IR-4 Tolerance Petition for Cymoxanil (Tanos) Use on Grapes, Hops: DW Assessment; D.Young and T. Steeger, 20/SEPT/2006, DP Num: 323681 and IR-4 Tolerance Petition for Cymoxanil (Tanos) Use on Caneberries: DW Assessment; D.Young and T. Steeger,  21/SEPT/2006, DP Num: 331978

The Environmental Fate and Effects Division (EFED) calculated screening level surface water and ground water estimates for cymoxanil using FIRST (version 1.0) model and the SCI-GROW model, respectively. The drinking water models and their descriptions are available at the EPA internet site:   HYPERLINK "http://www.epa.gov/oppefed1/models/water/"  http://www.epa.gov/oppefed1/models/water/ .  The newly proposed application rates for use on grapes and hops are higher than the rates evaluated in the previous Section 3 registration for the use of cymoxanil on potatoes (DP Num: 233366) and for the initial IR-4 tolerance petition for use of cymoxanil (Curzate 60 DF) on hops (DP Num: 271572).  Therefore new drinking water concentrations were determined for the proposed uses. Tier 1 drinking water concentrations (EDWCs) based on the newly proposed application rate for grapes appear in Table 2 as follows:

Table #2.  Estimated drinking water concentrations for Cymoxanil1

	Acute  (ppm)	Chronic  (ppm)

Groundwater	0.000003	0.000003

Surface Water	0.019	0.0001

1 Concentrations determined from the grape application (0.25 lbs per acre, 10 times), which was the highest application rate reported for the new proposed uses.

The higher chronic EDWC for surface water (0.0001 ppm) was used in this dietary exposure assessment. The drinking water EDWC was incorporated directly as a point estimate in the DEEM analysis under the food categories “water, direct, all sources” and “water, indirect, all sources.”

IV.	DEEM-FCID™ Program and Consumption Information

A cymoxanil chronic dietary exposure assessment was conducted using the Dietary Exposure Evaluation Model software with the Food Commodity Intake Database (DEEM-FCID™, Version 2.03), which incorporates consumption data from USDA’s Continuing Surveys of Food Intakes by Individuals (CSFII), 1994-1996 and 1998.  The 1994-96, 98 data are based on the reported consumption of more than 20,000 individuals over two non-consecutive survey days.  Foods “as consumed” (e.g., apple pie) are linked to EPA-defined food commodities (e.g. apples, peeled fruit - cooked; fresh or N/S; baked; or wheat flour - cooked; fresh or N/S, baked) using publicly available recipe translation files developed jointly by USDA/ARS and EPA.  For chronic exposure assessment, consumption data are averaged for the entire U.S. population and within population subgroups, but for acute exposure assessment are retained as individual consumption events.  Based on analysis of the 1994-96, 98 CSFII consumption data, which took into account dietary patterns and survey respondents, HED concluded that it is most appropriate to report risk for the following population subgroups: the general U.S. population, all infants (<1 year old), children 1-2, children 3-5, children 6-12, youth 13-19, adults 20-49, females 13-49, and adults 50+ years old.

For chronic dietary exposure assessments, an estimate of the residue level in each food or food-form (e.g., orange or orange juice) on the food commodity residue list is multiplied by the average daily consumption estimate for that food/food form to produce a residue intake estimate.  The resulting residue intake estimate for each food/food form is summed with the residue intake estimates for all other food/food forms on the commodity residue list to arrive at the total average estimated exposure.  Exposure is expressed in mg/kg body weight/day and as a percent of the cPAD.  This procedure is performed for each population subgroup.

Toxicological Information

The toxicological endpoints and doses chosen for dietary risk assessment are summarized below in Table 3.

Table # 3.  Summary of Cymoxanil Toxicological Doses and Endpoints for Dietary Risk Assessment

Exposure

Scenario

Dose Used in Risk Assessment, UF

Special FQPA SF* and Level of Concern for Risk Assessment

Study and Toxicological Effects

Acute Dietary

(Females 13-50 years of age)

NOAEL = 4 mg/kg

UF = 100

Acute RfD = 0.04 mg/kg

FQPA SF = 1X

aPAD = acute RfD

              FQPA SF

= 0.04 mg/kg

Developmental Toxicity (rabbit)

Offspring LOAEL = 8 mg/kg/day  based on increased skeletal malformations of he cervical and thoracic vertebrae and ribs

Acute Dietary

(General population including infants and children)

NOAEL = NA

UF = NA

Acute RfD = NA

FQPA SF =  NA

aPAD = acute RfD

              FQPA SF

= NA

Not Required.  An endpoint of concern (effect) attributable to a single dose was not identified in the database.

Chronic Dietary

(All populations)

NOAEL< 0.8 mg/kg/day

UF = 100

Chronic RfD = 0.008

 mg/kg/day

FQPA SF1 = 10X

(includes UFL =  10X

cPAD = chronic RfD

               FQPA SF

= 0.0008 mg/kg/day

Chronic toxicity (dog; 2003)

LOAEL = 1.3/0.8 mg/kg/day (M/F), based on decreased absolute and relative thymus weights and histopathology of the thymus (thymic atrophy/involution) in males and decreased thymus weights in females

UF = uncertainty factor, FQPA SF = Special FQPA safety factor, NOAEL = no-observed-adverse-effect-level, LOAEL = lowest-observed-adverse-effect-level, PAD = population adjusted dose (a = acute, c = chronic) RfD = reference dose, NA = Not Applicable

1  The 10X FQPA SF has been retained in the form of UFL to account for the use of a LOAEL to extrapolate a NOAEL.

VI.	Results/Discussion

concerned when dietary risk exceeds 100% of the PAD.  The DEEM-FCID™ analyses estimate the dietary exposure of the U.S. population and various population subgroups.  The chronic exposure results reported in Table # 4 are for the general U.S. Population, all infants (<1 year old), children 1-2, children 3-5, children 6-12, youth 13-19, females 13-49, adults 20-49, and adults 50+ years.

Results of Chronic Dietary Exposure Analysis

FCID™ software are below HED’s level of concern for the general U.S. population and each of the population subgroups.  Dietary exposure was estimated at 0.000271 mg/kg/day for the U.S. population         (34% of the cPAD) and 0.000405 mg/kg/day (51% of the cPAD) for the most highly exposed population subgroup (children, 1-2 years old).  The estimated exposures/risks for food and water combined are summarized in Table # 4 for all populations.

Table # 4.  Results of Chronic Dietary Exposure Analysis for Cymoxanil1

Population Subgroup

cPAD

(mg/kg/day)

Exposure (mg/kg/day)

% cPAD

General U.S. Population	0.0008	0.000271	34

All Infants (< 1 year old)	0.0008	0.000147	18

Children 1-2 years old	.0008	0.000405	51

Children 3-5 years old	0.0008	0.000389	49

Children 6-12 years old	0.0008	0.000263	33

Youth 13-19 years old	0.0008	0.000202	25

Adults 20-49 years old	0.0008	0.000293	37

Females 13-49 years old	0.0008	0.000233	29

Adults 50+ years old	0.0008	0.000219	27

1The population subgroup with the highest estimated chronic dietary (food + drinking water) exposure and risk is indicated by bold text.

VII.	Characterization of Inputs/Outputs

This chronic dietary exposure assessment for cymoxanil is a partially refined assessment which incorporates average field trial residues for lettuce, hops and grapes as well as screening level % CT data for several registered commodities.  Dietary exposure estimates could be further refined through the use of additional anticipated residues as well as refined EDWCs.  Since the estimated exposures using the current assumptions are below HED’s level of concern, additional refinements are not warranted at this time.

VIII.	Conclusions

ID™ indicates that dietary exposures to cymoxanil from food and drinking water are below HED’s level of concern for this pesticide.  Estimated chronic dietary exposures are less than or equal to 51% of the cPAD for the general U.S. population and all population subgroups.

IX.		List of Attachments

Chronic Food + Drinking Water Input File

Chronic Food + Drinking Water Results File

Chronic Food + Water Input File

U.S. Environmental Protection Agency                                 Ver. 2.00

DEEM-FCID Chronic analysis for CYMOXANIL                          1994-98 data

Residue file: C:\Documents and Settings\sstanton\My Documents\DEEM-FCID Files\cymoxanil\chronic food + water.R98

                                                               Adjust. #2 used

Analysis Date 04-05-2007             Residue file dated: 04-05-2007/13:35:08/8

Reference dose (RfD) = 0.0008 mg/kg bw/day

Comment:Cymoxanil chronic food + water using mean FT for lettuce, grape & hop; SLUA %CT for registered uses.

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

Food Crop                                       Residue       Adj.Factors      Comment

EPA Code  Grp  Food Name                          (ppm)

                                                             #1         #2

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

09020210 9B   Balsam pear                        0.050000   1.000      1.000

13010550 13A  Blackberry                         4.000000   1.000      1.000

13010560 13A  Blackberry, juice                  4.000000   1.000      1.000

13010561 13A  Blackberry, juice-babyfood         4.000000   1.000      1.000

13010580 13A  Boysenberry                        4.000000   1.000      1.000

09010750 9A   Cantaloupe                         0.050000   1.000      1.000

09010800 9A   Casaba                             0.050000   1.000      1.000

09020880 9B   Chayote, fruit                     0.050000   1.000      1.000

09021020 9B   Chinese waxgourd                   0.050000   1.000      1.000

09021350 9B   Cucumber                           0.050000   1.000      0.100

13011420 13A  Dewberry                           4.000000   1.000      1.000

08001480 8    Eggplant                           0.200000   1.000      1.000

95001750 O    Grape                              0.028500   1.000      1.000

95001760 O    Grape, juice                       0.028500   1.400      1.000

95001761 O    Grape, juice-babyfood              0.028500   1.400      1.000

95001770 O    Grape, leaves                      0.028500   1.000      1.000

95001780 O    Grape, raisin                      0.028500   1.000      1.000

95001790 O    Grape, wine and sherry             0.028500   1.000      1.000

09011870 9A   Honeydew melon                     0.050000   1.000      1.000

95001880 O    Hop                                9.400000   1.000      1.000

04012040 4A   Lettuce, head                      3.150000   1.000      0.100

13012080 13A  Loganberry                         4.000000   1.000      1.000

95002110 O    Lychee                             1.000000   1.000      1.000

95002120 O    Lychee, dried                      1.000000   1.850      1.000

08002340 8    Okra                               0.200000   1.000      1.000

08002700 8    Pepper, bell                       0.200000   1.000      0.100

08002701 8    Pepper, bell-babyfood              0.200000   1.000      0.100

08002710 8    Pepper, bell, dried                0.200000   1.000      0.100

08002711 8    Pepper, bell, dried-babyfood       0.200000   1.000      0.100

08002720 8    Pepper, nonbell                    0.200000   1.000      0.100

08002721 8    Pepper, nonbell-babyfood           0.200000   1.000      0.100

08002730 8    Pepper, nonbell, dried             0.200000   1.000      0.100

01032960 1C   Potato, chips                      0.050000   1.000      0.100

01032970 1C   Potato, dry (granules/ flakes)     0.050000   6.500      0.100

01032971 1C   Potato, dry (granules/ flakes)-b   0.050000   6.500      0.100

01032980 1C   Potato, flour                      0.050000   1.000      0.100

01032981 1C   Potato, flour-babyfood             0.050000   1.000      0.100

01032990 1C   Potato, tuber, w/peel              0.050000   1.000      0.100

01032991 1C   Potato, tuber, w/peel-babyfood     0.050000   1.000      0.100

01033000 1C   Potato, tuber, w/o peel            0.050000   1.000      0.100

01033001 1C   Potato, tuber, w/o peel-babyfood   0.050000   1.000      0.100

09023080 9B   Pumpkin                            0.050000   1.000      0.010

09023090 9B   Pumpkin, seed                      0.050000   1.000      0.010

13013200 13A  Raspberry                          4.000000   1.000      1.000

13013201 13A  Raspberry-babyfood                 4.000000   1.000      1.000

13013210 13A  Raspberry, juice                   4.000000   1.000      1.000

13013211 13A  Raspberry, juice-babyfood          4.000000   1.000      1.000

09023560 9B   Squash, summer                     0.050000   1.000      0.010

09023561 9B   Squash, summer-babyfood            0.050000   1.000      0.010

09023570 9B   Squash, winter                     0.050000   1.000      0.010

09023571 9B   Squash, winter-babyfood            0.050000   1.000      0.010

08003740 8    Tomatillo                          0.200000   1.000      1.000

08003750 8    Tomato                             0.200000   1.000      0.100

08003751 8    Tomato-babyfood                    0.200000   1.000      0.100

08003760 8    Tomato, paste                      0.200000   5.400      0.100

08003761 8    Tomato, paste-babyfood             0.200000   5.400      0.100

08003770 8    Tomato, puree                      0.200000   3.300      0.100

08003771 8    Tomato, puree-babyfood             0.200000   3.300      0.100

08003780 8    Tomato, dried                      0.200000  14.300      0.100

08003781 8    Tomato, dried-babyfood             0.200000  14.300      0.100

08003790 8    Tomato, juice                      0.200000   1.500      0.100

86010000 O    Water, direct, all sources         0.000100   1.000      1.000

86020000 O    Water, indirect, all sources       0.000100   1.000      1.000

09013990 9A   Watermelon                         0.050000   1.000      0.010

09014000 9A   Watermelon, juice                  0.050000   1.000      0.010

Chronic Food + Water Results File

U.S. Environmental Protection Agency                                 Ver. 2.00

DEEM-FCID Chronic analysis for CYMOXANIL                        (1994-98 data)

Residue file name: C:\Documents and Settings\sstanton\My Documents\DEEM-FCID Files\cymoxanil\chronic food + water.R98

                                                     Adjustment factor #2 used.

Analysis Date 04-05-2007/13:36:53     Residue file dated: 04-05-2007/13:35:08/8

Reference dose (RfD, Chronic) = .0008 mg/kg bw/day

COMMENT 1: Cymoxanil chronic food + water using mean FT for lettuce, grape & hop; SLUA %CT for registered uses.

======================================================================== =======

                    Total exposure by population subgroup

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

                                                    Total Exposure

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

          Population                         mg/kg             Percent of

           Subgroup                       body wt/day             Rfd

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

U.S. Population (total)                     0.000271                33.9%

U.S. Population (spring season)             0.000282                35.2%

U.S. Population (summer season)             0.000307                38.4%

U.S. Population (autumn season)             0.000249                31.2%

U.S. Population (winter season)             0.000247                30.9%

Northeast region                            0.000255                31.8%

Midwest region                              0.000287                35.9%

Southern region                             0.000229                28.6%

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Hispanics                                   0.000244                30.5%

Non-hispanic whites                         0.000295                36.8%

Non-hispanic blacks                         0.000174                21.8%

Non-hisp/non-white/non-black                0.000232                29.0%

All infants (< 1 year)                      0.000147                18.3%

Nursing infants                             0.000090                11.3%

Non-nursing infants                         0.000168                21.0%

Children 1-6  yrs                           0.000387                48.4%

Children 7-12 yrs                           0.000248                31.0%

Females 13-19 (not preg or nursing)         0.000174                21.7%

Females 20+ (not preg or nursing)           0.000223                27.9%

Females 13-50 yrs                           0.000227                28.4%

Females 13+ (preg/not nursing)              0.000153                19.1%

Females 13+ (nursing)                       0.000203                25.3%

Males 13-19 yrs                             0.000229                28.6%

Males 20+ yrs                               0.000325                40.6%

Seniors 55+                                 0.000212                26.5%

Children 1-2 yrs                            0.000405                50.6%

Children 3-5 yrs                            0.000389                48.6%

Children 6-12 yrs                           0.000263                32.9%

Youth 13-19 yrs                             0.000202                25.2%

Adults 20-49 yrs                            0.000293                36.7%

Adults 50+ yrs                              0.000233                29.1%

Females 13-49 yrs                           0.000219                27.4%

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

Cymoxanil                       Dietary Exposure Assessment                         DP Num: 338733               PC Code: 129106

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