UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, D.C.  20460

OFFICE OF

PREVENTION, PESTICIDES

AND TOXIC SUBSTANCES

MEMORANDUM

Date:		09-MAR-2007

Subject:		PP#s:  5E6911, 5E6926 and 5E6991.  Indoxacarb.  Petitions for
Tolerances on Vegetable, Leafy, Except Brassica (Group 4), Pome Fruits
(Group 11, except pear), Tuberous and Corm Vegetables (Subgroup 1C),
Cucurbit Vegetables (Group 9), Stone Fruits (Group 12), Cranberry, Mint,
Okra, and Southern Pea.  Summary of Analytical Chemistry and Residue
Data.

DP#s:	325479, 326516, 326544, 333333 	Decision #s:	355154, 360904,
356203, 355154

PC Code:	067710	MRID#s:	46520901, 46520902, 46487001, 46487002,
46651501, 46651502, 46651503, 46651504, 46651505, 46651506, 46651507

40 CFR	180.564	Chemical Class:	Oxadiazine Insecticide

From:		Sarah J. Levy, Chemist

		Registration Action Branch (RAB1)

		Health Effects Division (HED) (7509P)

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

		RAB1/HED (7509P)

To:		Daniel Rosenblat/Barbara Madden, Risk Management (RM) Team 05

		Registration Division (RD; 7505P)

This document was originally prepared under contract by Dynamac
Corporation (1910 Sedwick Road, Building 100, Suite B; Durham, NC 27713;
submitted 09-SEP-2006).  The document has been reviewed by the HED and
revised to reflect current Office of Pesticide Programs (OPP) policies.

Executive Summary

Indoxacarb is an oxadiazine insecticide (Group 22) used for control of
lepidopteran pests on a variety of fruit, vegetable and field crops.
Permanent tolerances are established for the combined residues of
indoxacarb, (S)-methyl
7-chloro-2,5-dihydro-2-[[(methoxycarbonyl)[4-(trifluoro
methoxy)phenyl]amino]carbonyl]indeno[1,2-e][1,3,4]oxadiazine-4a(3H)-carb
oxylate, and its inactive R-enantiomer in/on various plant commodities
at levels ranging from 0.01 ppm in/on peanuts and potatoes to 50 ppm
in/on alfalfa hay [40 CFR §180.564(a)].  Tolerances are also
established for combined residues of indoxacarb + its R-enantiomer in
livestock commodities at levels ranging from 0.03 ppm in livestock meat
byproducts to 4.0 ppm in milk fat.

The Interregional Research Project No. 4 (IR-4) has submitted three
petitions proposing new uses of indoxacarb, formulated as a 30%
water-dispersible granule (WDG; DuPont Avaunt® Insecticide; EPA Reg.
No. 352-597) on following crops or crop groups:  cranberry, cucurbit
vegetables (group 9), mint, southern pea and stone fruits (group 12).
Under these petitions, IR-4 has also proposed expanding existing uses
and tolerances on apples, lettuce, peppers and potatoes to cover pome
fruits (except pear, group 11), leafy vegetables except Brassica (group
4), okra, and tuberous and corm vegetables (subgroup 1C).  The proposed
uses on leaf petiole vegetables, mint, okra, and southern pea are for up
to four broadcast foliar applications at 0.065 lb ai/A, at minimum
retreatment intervals (RTIs) of 3-5 days, for a total application rate
of 0.26 lb ai/A/crop.  The proposed uses on cranberry, leafy green
vegetables (except spinach), pome fruits, stone fruits, and tuberous and
corm vegetables are for up to four broadcast foliar applications at 0.11
lb ai/A, at minimum RTIs of 3-7 days, for a total application rate of
0.44 lb ai/A/crop.  All uses allow applications using either ground or
aerial equipment, and the proposed preharvest intervals (PHIs) range
from 3 days (for cucurbits, okra, and leafy vegetables, except Brassica,
group 4) to 30 days (for cranberries).  In conjunction with these uses,
IR-4 is proposing permanent tolerances for combined indoxacarb residues
at levels ranging from 0.01 ppm in/on for tuberous and corm vegetables
to 14 ppm in/on leafy vegetables, except Brassica, group 4.

  SEQ CHAPTER \h \r 1 Adequate studies are available depicting the
uptake and metabolism of [14C]indoxacarb following applications to
cotton, lettuce and tomatoes.  Based on these studies, HED has
determined that indoxacarb +its R-enantiomer are the residues of concern
to be used in risk assessment and the tolerance expression for plants.
Adequate studies are also available depicting the metabolism of
indoxacarb in ruminants and poultry.  Based on the livestock metabolism
and feeding studies, HED has determined that the tolerance expression
should include indoxacarb + its R-enantiomer for milk and ruminant
commodities and the combined residues of indoxacarb, its R-enantiomer
and metabolites IN-JT333, IN-KT319, IN-JU873, IN-KG433, and IN-KB687 for
poultry commodities.  For purposes of risk assessment, metabolite
IN-MP819 will also be considered for milk and 5-OH-IN-JT333 and
Metabolite F will also be considered for poultry commodities.

Issues pertaining to livestock tolerances are not addressed under these
petitions as the proposed uses will not affect the current livestock
tolerances.  The only livestock feed items associated with the proposed
uses are wet apple pomace and potato culls and processed waste.  The
impact of indoxacarb residues from these commodities on livestock diets
were previously addressed under earlier petitions for uses on apples and
potatoes.

Two high-performance liquid chromatography (HPLC)/column
switching/ultraviolet (UV) methods (AMR 2712-93 and DuPont-11978) are
available for enforcing indoxacarb tolerances on plant commodities, and
a third gas chromatography (GC)/mass-selective detector (MSD) method
(AMR 3493-95, Supplement No. 4) is available for confirmation of
residues in plants.  The limits of quantitation (LOQs) for the HPLC
methods are 0.01-0.05 ppm for a variety of plant commodities, and the
limits of detection (LODs) are 0.0025-0.006 ppm.  For the GC/MSD method,
the LOQs range from 0.2 to 1.0 ppm depending on the matrix, and the LODs
are 0.0008-0.21 ppm.  Each of these methods determines both indoxacarb +
its R-enantiomer as a single component.

Another HPLC/column switching/UV Method (AMR 3337-95) is also available
for enforcing the current tolerances on livestock commodities.  The LOQ
for this method is 0.01 ppm and the LOD is 0.002-0.003 ppm.

In the field trials and processing studies submitted with the current
petitions, combined indoxacarb residues were determined using either the
GC/MSD method (AMR 3493-95), the HPLC/UV Method (AMR 2712-93), or a
modified version of the HPLC method.  Each method was adequately
validated in conjunction with sample analyses.  The validated LOQs for
indoxacarb residues were 0.01 ppm for cantaloupes, cucumbers, southern
peas, peaches, plums and prunes, 0.02 ppm for cherries, spinach and
celery, 0.05 ppm for cranberries and mint tops, and 0.10 ppm for mint
oil.

Adequate storage stability data have been previously reviewed   SEQ
CHAPTER \h \r 1 indicating that indoxacarb residues are stable in frozen
storage for up to 6-23 months in a wide variety of plant commodities.
In addition, adequate storage stability data were provided with the new
field trials and processing studies.  These data also indicate that
indoxacarb is stable in frozen storage for at least 1.5 months in
cranberries, 5-8 months in peaches, plums, prunes, and mint tops and
oil, 10-12 months in peas, celery, spinach, cantaloupes, and squash, 15
months in cherries, and 24 months in cucumbers.  These data support the
sample storage intervals and conditions used in the submitted field
trails and processing studies.

The submitted field trials on spinach, cucurbit vegetables, stone
fruits, cranberries and mint are adequate and support the proposed use
patterns for indoxacarb (30% WDG) on these crops or crop groups.  The
number and geographic distribution of the field trials are adequate, and
the appropriate samples were collected at the proposed PHIs.  The
available field trial data on celery are adequate to support a crop
group tolerance for the crop group vegetable, leafy, except Brassica
(group 4).  The southern pea field trials are also adequate; however,
the petitioner did not specify if they wanted succulent or dry.  The
field trial data the submitted were for dry peas.  The proposed label
directions for southern peas should be amended to allow for applications
only to varieties used to produce dry seed.  If the petitioner intends
to support a generalized use on southern peas, then field trials will be
required for succulent varieties as well.  Acceptable field trial data
are also available from earlier petitions supporting uses of indoxacarb
(30% WDG) on potatoes, leaf and head lettuce, apples and peppers.  Data
on the representative crops of potatoes, lettuce, and apples will
support expanding the use of indoxacarb to cover similar uses on
tuberous and corm vegetables (subgroup 1C), vegetable, leafy, except
Brassica (group 4), and pome fruits (group 11, except pear).  The
available field trials on tomatoes and peppers will be translated to
support the same use pattern for indoxacarb (WDG) on okra, as okra is
now considered part of the “vegetable, fruiting, group 8” crop
group.

Adequate processing studies are available for mint and plums.  A
separate tolerance is not required for mint oil as residues were reduced
on average by 0.028x in mint oil.  Although residues were shown to
concentrate by 4x in prunes, a separate tolerance is not required for
prunes.  Based on the highest-average field trial (HAFT) residues for
plums (0.185 ppm) and the above processing factor, the maximum expected
residues in prunes would be 0.74 ppm, which is below the recommended
tolerance for stone fruits (0.90 ppm).  Processing studies on apples and
potatoes were previously considered under earlier petitions.  Based on
these petitions, no tolerances were required for potato processed
products and a 3.0 ppm tolerance was established for wet apple pomace.

With regards to rotational crops, an adequate confined rotational crop
study is available, and HED has concluded the residues of concern in
rotational crops are indoxacarb + its R-enantiomer.  HED has also
concluded that the 30-day rotational crop restriction, currently on the
label, is acceptable for all crops without registered indoxacarb uses.

Residue Chemistry Deficiencies

Pending submission of a revised Section B (see requirements under
Directions for Use), and a revised Section F (see requirements under
Proposed Tolerances), there are no residue chemistry issues that would
preclude granting an unconditional registration for the requested uses
of indoxacarb.  The proposed uses and the submitted data support the
following permanent tolerances for the combined residues of indoxacarb +
its R-enantiomer in/on the following raw agricultural commodities
(RACs):

Cranberry	0.90 ppm

Fruit, pome, except pear, group 11	1.0 ppm

Fruit, stone, group 12	0.90 ppm

Vegetable, leafy, except Brassica, group 4………….14 ppm

Peppermint………………………………………….. 11 ppm

Spearmint……….…………………………………..	  11 ppm

Okra	0.50 ppm

Pea, southern, seed	0.10 ppm

Vegetable, cucurbit, group 9	0.60 ppm

Vegetable, tuberous and corm, subgroup 1C	0.01 ppm

A human-health risk assessment will be prepared as a separate document.

Background

Indoxacarb is an oxadiazine insecticide (mode of action group 22) used
primarily to control larval stages of lepidopteran pests on a variety of
fruit, vegetable and field crops.  It is a reduced-risk insecticide
registered for use on various food and feed crops to E.I. du Pont de
Nemours Company as a 30% WDG (DuPont Avaunt® Insecticide; EPA Reg. No.
352-597) and a 1.25 lb/gal FlC (DuPont Steward® Insecticide; EPA Reg.
No. 352-598).  These end-use formulations contain an isometric mixture
of indoxacarb (insecticidally active S-enantiomer; DPX-KN128) + its
R-enantiomer (insecticidally inactive; IN-KN127); however, the
percentage of ai listed on the labels and the labeled use rates for each
crop are based only on the amount of indoxacarb.

Permanent tolerances are currently established for the combined residues
of indoxacarb + its inactive R-enantiomer in/on various plant
commodities at levels ranging from 0.01 ppm in/on peanuts and potatoes
to 50 ppm in/on alfalfa hay [40 CFR §180.564(a)].  Tolerances are also
established in livestock commodities at levels ranging from 0.03 ppm in
meat byproducts to 4.0 ppm in milk fat.

IR-4 has submitted petitions (PP# 5E6911, 5E6926, and 5E6991) proposing
to amend the label for DuPont’s 30% WDG to include new uses on
cranberry, cucurbit vegetables (group 9), leafy vegetables except
Brassica, mint, okra, pome fruits (group 11, except pear), southern
peas, stone fruits (group 12), and tuberous and corm vegetables
(subgroup 1C).  In conjunction with these uses, the petitioner is
proposing the following tolerances:

Cranberry	1 ppm

Fruit, pome, except pear, group 11	1.0 ppm

Fruit, stone group 12	1 ppm

Leafy vegetables except Brassica 	 14 ppm

Mint	10 ppm

Okra	0.5 ppm

Pea (southern)	0.1 ppm

Vegetable, cucurbit, group 9	0.5 ppm

Vegetable, tuberous and corm, subgroup 1C	0.01 ppm

The nomenclature and physicochemical properties of indoxacarb are
presented below in Tables 1 and 2.

Table 1.	Indoxacarb Nomenclature.

Compound

Common name	Indoxacarb

Company experimental name	DPX-KN128

IUPAC name	(S)-methyl
7-chloro-2,5-dihydro-2-[[(methoxycarbonyl)[4-(trifluoromethoxy)phenyl]am
ino]carbonyl]indeno[1,2-e][1,3,4]oxadiazine-4a(3H)-carboxylate

CAS name	  SEQ CHAPTER \h \r 1 methyl
(4aS)-7-chloro-2,5-dihydro-2-[[(methoxycarbonyl)[4-

(trifluoromethoxy)phenyl]amino]carbonyl]indeno[1,2-e][1,3,4]oxadiazine-4
a(3H)-carboxylate

CAS registry number	173584-44-6

End-use product (EP)	30% WDG (DuPont Avaunt® Insecticide; EPA Reg. No.
352-597)

Regulated Enantiomer

Company experimental name 	IN-KN127 (inactive R-enantiomer)

TABLE A.2.	Physicochemical Properties of Technical Grade Indoxacarb.

Parameter	Value	Reference

Melting point/range	140-141ºC	Memo, S. Levy, 19-JAN-2000; DP#: 244253

pH	5.32 at 25ºC

	Relative Density	1.34 at 20ºC

	Water solubility (25°C)	15.4 ± 2.3 ppb in pH 5 buffer

	Solvent solubility(25°C)	1.72 g/L in n-heptane; 14.5 g/L in 1-octanol;
103 g/L in methanol; 117 g/L in o-xylene; 139 g/L in acetonitrile; 160
g/L in ethyl acetate; and >250 g/kg in methylene chloride, acetone, and
dimethyl-formamide

	Vapor pressure (25ºC)1	2.5 x 10-8 Pa

	Dissociation constant, pKa1	Does not dissociate at pHs of 2.42-11.36

	Octanol/water partition coefficient, Log(KOW)	4.65 at pH 5

	UV/visible absorption spectrum (λmax, nm)1	Molar absorptivities at 3
maxima were affected by pH, but not over wavelengths of environmental
significance.

	1   Properties are for pure active ingredient.  These properties were
not reported for technical grade indoxacarb.

860.1200 Directions for use

IR-4 has proposed amending the label for DuPont™ Avaunt® Insecticide
(EPA Reg. No. 352-597) to include new uses on cranberry, cucurbit
vegetables (group 9), mint, southern peas, and stone fruits (group 12).
The petitioner has submitted new field trial data to support these uses.
 IR-4 has also proposed using existing field trial data, as well as some
new field trial data (for some crops), on apples, lettuce, peppers, and
potatoes to support expanding the uses on the 30% WDG to cover pome
fruits (expect pear), leafy vegetables except Brassica, okra, and
tuberous and corm vegetables.  The petitioner provided both a summary of
the proposed uses and an example label from DuPont containing the use
directions.  The proposed use directions are summarized below in Table
3.

Table 3.     Summary of Proposed Use Directions for Indoxacarb.

Applic. Timing, Type, and Equip.1	Formulation

[EPA Reg. No.]	Applic. Rate

(lb ai/A)	Max. No. Applic. per Season	Max. Seasonal Applic. Rate

(lb ai/A)	PHI

(days)	Use Directions and Limitations2

Cranberry

Broadcast foliar applications using ground or aerial equipment	30% WDG

[352-597]	0.11	4	0.44	30	Minimum RTI is 7 days.

Do not apply to flow through bogs or allow release of irrigation water
from bogs for at least 1 day following application.

Cucurbit Vegetables

Broadcast foliar applications using ground or aerial equipment	30% WDG

[352-597]	0.045-0.11	4	0.44	3	Minimum RTI is 5 days.  Make uniform
application of insecticide in 10-50 GPA of water.  For ground
application, apply using a minimum of 10 GPA of water.

Leafy Green Vegetables, except spinach

Broadcast foliar applications using ground or aerial equipment	30% WDG

[352-597]	0.045-0.11	4	0.44	3	Minimum RTI is 3 days.

Leaf Petiole Vegetables

Broadcast foliar applications using ground or aerial equipment	30% WDG

[352-597]	0.065	4	0.26	3	Minimum RTI is 3 days.

Mint

Broadcast foliar applications using ground or aerial equipment	30% WDG

[352-597]	0.065	4	0.26	7	Minimum RTI is 3 days.  Use a minimum of 20 GPA
of water for ground applications.

Okra

Broadcast foliar applications using ground or aerial equipment	30% WDG

[352-597]	0.065	4	0.26	3	Minimum RTI is 5 days.

Pome Fruits, except pears

Foliar applications using ground or aerial equipment	30% WDG

[352-597]	0.056-

0.11	4	0.44	14	Minimum RTI is 7 days.  For best results, apply a uniform
application of insecticide in 50-150 GPA of water.  Do not apply in a
dilute application of more than 200 GPA of water.

Southern Pea

Broadcast foliar applications using ground or aerial equipment	30% WDG

[352-597]	0.065	4	0.26	7	Minimum RTI is 3 days.  Make a uniform
application in approximately 20-100 GPA of water.

Spinach

Broadcast foliar applications using ground or aerial equipment	30% WDG

[352-597]	0.065	4	0.26	3	Minimum RTI is 3 days.

Stone Fruits

Foliar applications using ground or aerial equipment	30% WDG

[352-597]	0.09-

0.11	4	0.44	14	Minimum RTI is 7 days.  For best results, apply a uniform
application of insecticide in 50-150 GPA of water.  Do not apply in a
dilute application of more than 200 GPA of water.

Tuberous and Corm Vegetables

Broadcast foliar applications using ground or aerial equipment	30% WDG

[352-597]	0.045-0.11	4	0.44	7	Minimum RTI is 5 days.  For aerial
application, use a minimum of 5 GPA of water.

1	Do not apply through any type of irrigation equipment, except as
allowed by supplemental labels.

2	The label currently specifies a minimum re-entry interval (REI) of 12
hours and a rotation crop restriction of 30 days for food/feed crops not
registered for use with indoxacarb.  Unless otherwise specified, apply
aerial applications in a minimum of 5 gallons per acre (GPA) or 10 GPA
for tree and orchard crops.

RTI = retreatment interval.

  SEQ CHAPTER \h \r 1 Conclusions.  The proposed use directions
adequately reflect the use patterns used in the new or previously
reviewed field trials, with the exception of southern peas.  Based on
the available southern pea field trials, it is unclear whether the
petitioner is pursing a use on succulent or dry southern peas.  The
proposed label directions for southern peas should be amended to allow
applications only to varieties used to produce dry seed.  If the
petitioner intends to support a generalized use on southern peas, field
trials will be required for the succulent variety as well.  In addition,
the use directions for southern peas should prohibit applications to
varieties grown for livestock feed.  A revised Section B should be
submitted.

860.1300 Nature of the Residue – Plants

  SEQ CHAPTER \h \r 1 Adequate metabolism studies on cotton, lettuce,
and tomatoes were reviewed in conjunction with an earlier petition
(Memo, S. Levy, 19-JAN-2000; DP#: 244253).  Based on these studies, the
HED Metabolism Assessment Review Committee (MARC) determined that the
residue of concern in plants is indoxacarb + its R-enantiomer (Memo, S.
Levy, 10-JUL-2000; DP#: 263986).

860.1300 Nature of the Residue – Livestock

  SEQ CHAPTER \h \r 1 Adequate ruminant and poultry metabolism studies
were reviewed in conjunction with an earlier petition (Memo, S. Levy,
19-JAN-2000; DP#: 244253).  Based on these studies, the MARC has
determined that the tolerance expression for milk and ruminant
commodities will include indoxacarb + its R-enantiomer (Memo, S. Levy,
10-JUL-2000; DP#: 263986).  However, for purposes of risk assessment,
the metabolite IN-MP819 will also be considered in milk.  For poultry
commodities, HED has recommended that tolerances be established for the
combined residues of the indoxacarb + its R-enantiomer, IN-JT333,
IN-KT319, IN-JU873, IN-KG433, and IN-KB687 (Memo, S. Levy, 22-SEP-2004;
DP#: 297936).  For purposes of risk assessment, residues of concern in
poultry commodities also includes 5-OH-IN-JT333 and Metabolite F (Memo,
S. Levy, 04-OCT-2001; DP#: 277922).

860.1340 Residue Analytical Methods

A number of adequate methods are available for enforcing indoxacarb +
its R-enantiomer tolerances on plant and livestock commodities, and each
of these methods determines both indoxacarb + its R-enantiomer as a
single component.

The primary method for plant commodities is an HPLC/column switching/UV
method (Method AMR 2712-93), which was validated by HED and forwarded to
the United States Food and Drug Administration (U. S. FDA) for inclusion
in Pesticide Analytical Manual (PAM) Vol. II (Memo, S. Levy,
12-OCT-2000; DP#: 267339).  For this method, residues are extracted with
hexane-saturated acetonitrile (ACN):ACN-saturated hexane and
centrifuged.  Residues in the ACN phase are purified by solid-phase
extraction (SPE) using silica-gel and strong-anion exchange (SAX)
cartridges.  Residues are then determined by column switching HPLC/UV
(310 nm) using C18 and cyano columns, with an external standard.  The
method LOQs range from 0.01-0.05 ppm for a variety of plant commodities,
and the LOD is 0.0025 ppm.

For confirmation of residues in plant commodities, a GC/MSD method
(Method AMR 3493-95, Supplement No. 4) is available, which was also
validated by HED and forwarded to the FDA (Memo, S. Levy, 09-MAY-2002;
DP#: 282821).  For this method, residues are extracted with ethyl
acetate:water and filtered, and residues in the ethyl acetate fraction
are concentrated and purified using silica gel and carbon SPE
cartridges.  Residues are then determined by GC/MSD using an external
standard.  Residues are quantified using the m/z 527 ion, and
confirmatory analyses utilize the 218, 321 and 527 ions.  The method
LOQs range from 0.2-1.0 ppm depending on the matrix, and the LODs are
0.0008-0.21 ppm.

An additional HPLC/column switching/UV method (Method DuPont-11978;
Memo, S. Levy, 18-FEB-2005; DP#: 313518) is also available, which
combines the extraction procedures of Method AMR-3493-95 with the
cleanup and determination procedures of Method AMR 2712-93.  For this
method, residues are extracted with ethyl acetate:water, and residues in
the ethyl acetate fraction are purified by SAX SPE and determined by
column switching HPLC/UV (310 nm) using cyano and C18 columns, with an
external standard.  For grape matrices, the method LOQ is 0.01 ppm and
the LOD is 0.006 ppm.

For enforcing the current tolerances in livestock commodities, another
HPLC/column switching/UV Method (Method AMR 3337-95) is available, which
is capable of determining residues of parent and the metabolite IN-JT333
in livestock matrices.  This method has also been forwarded to the FDA
for inclusion in PAM, Vol. II (Memo, S. Levy, 12-OCT-2000; DP#: 267339).
 Depending on the matrix, residues extracted with either ACN, ACN:hexane
or ethyl acetate.  Residues are then purified by solvent partitioning
between ACN and hexane, followed by cleanup by SPE using either C18 or
silica gel cartridges.  Residues are determined by column switching
HPLC/UV (310 nm) using cyano and C18 columns, with an external standard.
 The method LOQ is 0.01 ppm and the LOD is 0.002-0.003 ppm.  Residues
can be confirmed by GC/MSD using the m/z 527 and 469 ions.

In the field trials and processing studies submitted with the current
petitions, combined indoxacarb residues were determined using one of the
plant enforcement methods or a modification of an enforcement method.
Each data collection method was adequately validated in conjunction with
the samples analyses, using control samples fortified at an appropriate
range of concentrations.  Acceptable recoveries were obtained for all
commodities.

The GC/MSD method AMR 3493-95 was used for determining residues in
spinach, celery, cranberries and mint tops and oil.  The validated
method LOQs were 0.02 ppm for spinach and celery, 0.05 ppm for
cranberries and mint tops, and 0.10 ppm for mint oil.

The HPLC/column switching/UV method AMR 2712-93 was used for determining
residues in squash, and a modified version of this method, using only a
single cyano column for analysis, was used for determining residues in
southern peas and stone fruits.  The validated method LOQs were 0.01 ppm
for southern peas, peaches, plums and prunes, and 0.02 ppm for cherries.

Another modified version of Method AMR 2712-93 was used for determining
residues in cantaloupes and cucumbers.  The method was modified by
eliminating the SPE cleanup step and using LC/MS/MS for determination of
residues.  The validated method LOQ was 0.01 ppm for both cantaloupes
and cucumbers.

Conclusions.  Adequate methods are available for enforcing the proposed
tolerances on plant commodities, and residues in the available field
trials and processing studies were determined using either an
enforcement methods or an adequate method derived from an enforcement
method.

860.1360 Multiresidue Methods

Acceptable data are available depicting the recovery of indoxacarb + its
R-enantiomer using FDA multiresidue method protocols (PAM, Vol. I) C, D,
and E.  Indoxacarb + its R-enantiomer were not evaluated through
Protocol A because it does not possess an N-methylcarbamate structure.
It was not tested through Protocol B because it does not possess a
carboxylic acid or phenolic moiety.  It was not tested through Protocol
F because indoxacarb + its R-enantiomer are not recoverable from
Florisil at a level ≥30%.  Indoxacarb + its R-enantiomer are
completely recovered through Protocol D; however, matrix enhancement
effects were seen in certain matrices.  The results of multiresidue
testing were forwarded to FDA for review (Memo, S. Levy, 03-NOV-1999;
DP#: 260955).

860.1380 Storage Stability

Storage stability data have been reviewed in   SEQ CHAPTER \h \r 1
conjunction with earlier petitions (Memos, S. Levy, 19-JAN-2000; DP#:
244253; 07-SEP-2000; DP#: 267325; and 14-APR-2004; DP#: 290172)
indicating that residues of indoxacarb + its R-enantiomer are relatively
stable in frozen storage on a wide variety of plant commodities.  These
studies indicate that indoxacarb + its R-enantiomer are stable in frozen
storage for up to 6 months in apple juice; 10-12 months in broccoli, wet
apple pomace, wet grape pomace, wine, tomatoes, peppers, and cotton
hulls, meal and refined oil; 13-15 months in pears, cabbage, lettuce,
cottonseed, and cotton gin byproducts; 18 months in apples and grapes;
and 19-23 months in corn forage, stover and ears.

In addition to the above data, storage stability studies were conducted
in conjunction with each of the new field trials and processing studies.
 In each study, control samples were fortified with indoxacarb at
0.1-1.0 ppm and placed in frozen storage with the field trial or
processing study samples.  At intervals reflecting the maximum storage
interval for treated crops, duplicate or triplicate stored samples were
analyzed along with a control sample and freshly fortified samples.
Average corrected recoveries of indoxacarb following frozen storage were
85-109% for each commodity, with the exception of spinach, which had a
recovery of 73%.  These data indicate that indoxacarb is stable in
frozen storage for at least 1.5 months in cranberries; 5-8 months in
mint tops and oil, peaches, plums and prunes; 10-12 months in peas,
celery, spinach, cantaloupes, and squash; 15 months in cherries; and 24
months in cucumbers.

Conclusions.  The available storage stability data are adequate and
support the sample storage intervals and conditions used in the field
trails and processing studies.

860.1400 Water, Fish, and Irrigated Crops

There are no aquatic uses are being proposed in the current petitions.
Although cranberry fields can be flooded for irrigation and are flooded
for harvest of fruit, the proposed PHI for cranberries is 30 days and
the label directions also prohibit releasing irrigation water from bogs
for at least 1 day following application.  Therefore, no data are
required under this guideline.

860.1460 Food Handling

This guideline requirement is not relevant to the current petition as no
food handling uses are being proposed.

860.1480 Meat, Milk, Poultry, and Eggs

The only livestock feed items associated with the proposed uses are wet
apple pomace and potato culls and processed waste, which are covered
under the proposed uses for pome fruits and tuberous and corm
vegetables.  The effects of indoxacarb residues in these commodities on
livestock diets were previously addressed under earlier petitions
supporting uses on apples and potatoes (Memos, S. Levy, 19-JAN-2000;
DP#: 244253 and 30-MAY-2002; DP#: 276516).  As the proposed uses will
not alter the dietary exposure of livestock, data requirements
pertaining to meat, milk, poultry, and eggs will not be further
addressed under the current petitions.

860.1500 Crop Field Trials

46520901.der (southern pea)	46520902.der1 (mint)	46487001.der (spinach)

46487002.der (celery)	46651501.der (cantaloupe)	46651502.der (cucumber)

46651503.der (summer squash)	46651504.der (cherry)	46651505.der (peach)

46651506.der1 (plum)	46651507.der (cranberry)

To support the proposed new uses of indoxacarb (30% WDG), IR-4 has
submitted crop field trials on cherries, plums, peaches, cucumbers,
summer squash, cantaloupes, mint, cranberry, and southern peas.    SEQ
CHAPTER \h \r 1 The results from these studies are discussed below and
summarized in Table 4.

To support the purposed uses on pome fruits (group 11, except pear),
leafy vegetables except Brassica (group 4), and tuberous and corm
vegetables (subgroup 1C), IR-4 cited the existing tolerances and field
trial data on apples, leaf and head lettuce, and potatoes.  IR-4 also
submitted new field trial data on spinach and celery to support the crop
group tolerance on leafy vegetables except Brassica (group 4).
Furthermore, IR-4 requested that the existing tolerance and residue data
on peppers be translated to support the proposed use on okra.

Table 4.	Summary of Residue Data from Field Trials on Spinach, Celery,
Cucurbit Vegetables, Southern Pea, Stone Fruits, Cranberry, and Mint
Following Application of Indoxacarb (30% WDG).

Commodity	Total Applic. Rate

(lb ai/A)	PHI (days)	Residue Levels (ppm)1

	n	Min.	Max.	HAFT2	Median	Mean	Std. Dev.

Leafy Vegetables except Brassica, group 4 (proposed maximum application
rate:  0.26 lb ai/A; PHI: 3 days)

Spinach	0.268	3	16	2.2	13.0	10.5	4.45	5.27	2.59

7	16	0.49	6.1	5.20	2.90	3.16	1.44

14	14	0.29	2.5	2.35	1.90	1.69	0.70

Celery

Untrimmed Stalks (RAC)	0.268	7	12	0.32	1.80	1.70	1.20	1.07	0.62

14	12	0.12	1.00	0.99	0.37	0.51	0.36

21	12	0.11	0.77	0.50	0.21	0.27	0.18

Celery Trimmed Stalks	0.268	3	12	0.31	1.90	1.75	0.54	0.82	0.55

7	12	0.21	0.65	0.62	0.37	0.38	0.13

14	12	0.12	0.53	0.38	0.19	0.24	0.13

Southern Peas (proposed maximum application rate:  0.26 lb ai/A; PHI: 7
days)

Mature Seed3	0.255-0.266	6-7	14	<0.01	0.067	0.065	0.014	0.021	0.021

Cucurbit Vegetables (proposed maximum application rate:  0.44 lb ai/A;
PHI: 3 days)

Cantaloupe	0.437-0.475	3-4	22	0.018	0.393	0.312	0.064	0.102	0.095

Cucumber	0.414-0.463	3	20	<0.01	0.069	0.055	0.020	0.022	0.014

Summer Squash	0.423-0.459	2-4	22	<0.01	0.120	0.102	0.024	0.032	0.033

Stone Fruits (proposed maximum application rate:  0.44 lb ai/A; PHI: 14
days)

Cherry	0.437-0.468	12-144	32	0.07	0.64	0.63	0.20	0.25	0.16

Peach	0.420-0.449	13-144	30	0.03	0.59	0.59	0.10	0.16	0.14

Plum	0.431-0.448	13-15	22	<0.01	0.19	0.185	0.020	0.045	0.050

Cranberry (proposed maximum application rate:  0.44 lb ai/A; PHI: 30
days)

Cranberry	0.438-0.451	13-15	12	0.11	0.39	0.32	0.22	0.23	0.09

28-30	12	0.086	0.69	0.63	0.15	0.22	0.20

Mint (proposed maximum application rate:  0.26 lb ai/A; PHI: 7 days)

Mint Tops	0.260-0.270	7-8	12	2.10	6.84	6.37	3.06	3.87	1.83

1       The validated LOQ is 0.01 ppm for cantaloupes, cucumbers,
squash, southern peas, peaches and plums; 0.02 ppm for spinach, celery
and cherries; and 0.05 ppm for cranberries and mint.  For samples having
residues <LOQ, ½ LOQ was used for calculating of the median, mean and
standard deviation.

2	HAFT = Highest-Average Field Trial.

3	Samples were only identified as “mature seed” and did not specify
whether samples were dry seed or succulent seed.

4	Includes samples from one cherry trial collected at 5 days after the
last application (DALA) and one peach trial at 7 DALA.  Residues in/on
samples from these earlier intervals were similar to residues in/on
samples collected at ~14 DALA.

Tuberous and Corm Vegetables (subgroup 1C).  Acceptable field trial data
are available supporting the use of indoxacarb (30% WDG) on potatoes
(Memo, S. Levy, 30-MAY-2002; DP#: 276516).  As potatoes are the
representative crop for subgroup 1C and the proposed use is identical to
the existing use on potatoes, the potato field trial data will support
the expanded use of indoxacarb (30% WDG) on tuberous and corm
vegetables.

Vegetable, Leafy, except Brassica, (group 4)

The representative commodities for the vegetable, leafy, except
Brassica, (group 4) are celery, head lettuce, leaf lettuce, and spinach.
 Acceptable field trial data are available supporting the use of
indoxacarb (30% WDG) on leaf and head lettuce (Memo, S. Levy,
19-JAN-2000; DP#: 244253).  Additional spinach and celery data have been
submitted in support of the current petition.

Spinach.  In eight field trials conducted in the growing zones 1, 2, 6,
9 and 10 during 1996-1997, indoxacarb (30% WDG) was applied to spinach
as four broadcast foliar applications during crop development at 0.0669
lb ai/A/application, at RTIs of 2-4 days, for totals of 0.268 lb ai/A
(1x rate).  All applications were made using ground equipment at 15-35
GPA, without the use of any adjuvants.  Duplicate control and treated
samples of mature spinach were harvested from each trial at 3, 7 and 14
DALA, and additional samples were collected at 0 and 20 DALA from one
site to examine residue decline.  Samples were stored frozen up to 11
months prior to extraction for analysis, an interval supported by the
available concurrent storage stability data.  Samples were analyzed for
combined indoxacarb residues using an adequate GC/MSD method
(AMR-3493-95), which has a validated LOQ was 0.02 ppm.  The LOD was not
reported.

Following four applications totaling 0.268 lb ai/A (1x rate), combined
indoxacarb residues in/on spinach were 2.2-13 ppm at 3 DALA (proposed
PHI), 0.49-6.1 ppm at 7 DALA, and 0.29-2.5 ppm at 14 DALA.  Average
residues at 3, 7 and 14 DALA were 5.27, 3.16, and 1.69 ppm,
respectively, and the HAFT residues at the same intervals were 10.5,
5.20, and 2.35 ppm.

Celery.  In seven field trials conducted during 1996 in the U.S.,
indoxacarb was applied to celery as four broadcast foliar applications
during crop development at 0.0669 lb ai/A/application, at RTIs of 3-5
days, for a total rate of  0.268 lb ai/A (1x rate).  Six field trials
used the 30% WDG formulation, and one field trial used the 15%
suspension concentrate (1.25 lb/gal FlC).  All applications were made
using ground equipment at 20-50 GPA, without the use of any adjuvants.
Duplicate control and treated samples of untrimmed celery (RAC) were
collected from each trial at 7, 14, and 21 DALA, and duplicate samples
of trimmed celery were collected from each trial at 3, 7, and 14 DALA.
In two decline studies, untrimmed celery samples were collected at 0, 7,
14, 21 and 28 DALA, and trimmed celery samples were collected at 0, 3,
7, 14, and 21 DALA.  Samples were stored frozen up to 10.5 months prior
to extraction for analysis, an interval supported by the available
concurrent storage stability data. Samples were analyzed for combined
indoxacarb residues using an adequate GC/MSD method (AMR-3493-95), which
has a validated LOQ was 0.02 ppm and a reported LOD of 0.007 ppm.

Following four broadcast foliar applications of the 30% WDG at a 1x
rate, combined residues in/on untrimmed celery (RAC) were 0.32-1.8 ppm
at 7 DALA, 0.12-1.0 ppm at 14 DALA, and 0.11-0.77 ppm at 21 DALA.
Average residues in/on untrimmed celery were 1.07, 0.51, and 0.24 ppm at
7, 14, and 21 DALA, respectively; and HAFT residues were 1.70, 0.99, and
0.50 ppm at the same intervals.  Combined residues in/on trimmed celery
samples were 0.31-1.90 ppm at 3 DALA, 0.21-0.65 ppm at 7 DALA, and
0.12-0.53 ppm at 14 DALA.  Average residues in/on trimmed celery were
0.82, 0.38, and 0.24 ppm at 3, 7, and 14 DALA, respectively; and HAFT
residues were 1.75, 0.62, and 0.38 ppm at the same intervals.  Residue
data from the field trial using the 1.25 lb/gal FlC were not included in
calculating residue ranges and averages.

Note that data are not available for untrimmed celery at the proposed
PHI of 3 days.  However, HED used the trimmed celery residue data to
estimate untrimmed celery residues as follows:  Indoxacarb residue
concentrations in trimmed and untrimmed celery were compared for 0-day,
7-day, and 14-day PHI samples.  Based on this comparison, trimmed to
untrimmed ratios were determined to be 2.32 for the 0-day PHI samples,
3.0 for the 7-day PHI samples and 2.3 for the 14-day PHI samples.  The
average residue ratio for these three sampling intervals was calculated
to be 2.5.  The 3-day trimmed celery residue data were entered into the
U.S. EPA tolerance calculator, resulting in a trimmed celery tolerance
of 3.5 ppm.  To determine an untrimmed tolerance value, the 3.5 ppm
value was multiplied by the average trimmed to untrimmed residue ratio
of 2.5, resulting in a value of ~9.0 ppm.

Cucurbit Vegetables (group 9)

Cantaloupes.  In 11 field trials conducted in the U.S. and Canada during
2003, indoxacarb (30% WDG) was applied to cantaloupes as four broadcast
foliar applications during fruit development at 0.101-0.129 lb
ai/A/application, at RTIs of 4-6 days, for a total of 0.436-0.475 lb
ai/A/season (1x rate).  All applications were made using ground
equipment at 21-45 GPA, without the use of any adjuvants.  Duplicate
control and treated samples of mature cantaloupes were harvested from 10
sites at 3-4 DALA, and at one site, samples were harvested at 1, 3, 5
and 12 DALA to assess residue decline.  Samples were stored frozen for
up to 360 days prior to extraction for analysis, an interval supported
by available concurrent storage stability data.  Samples were analyzed
for combined indoxacarb residues using an adequate LC/MS/MS method,
which is a modified version of a tolerance enforcement (HPLC/UV Method
AMR 2712-93).  The lowest limit of method validation (LLMV) was 0.01
ppm, and the calculated LOQ and LOD were 0.008 and 0.003 ppm,
respectively.

Following four applications at a total rate of 0.436-0.475 lb ai/A (1x
rate), combined residues were 0.018-0.393 ppm in/on 22 samples of
cantaloupes harvested at 3-4 DALA.  The HAFT residues were 0.312 ppm,
and average residues were 0.102 ppm.  In the residue decline trial,
average residues declined steadily from 0.126 ppm at 1 DALA to 0.044 ppm
at 12 DALA.

Cucumbers.  In ten field trials conducted in the U.S. during 2002,
indoxacarb (30% WDG) was applied to cucumbers as four broadcast foliar
applications during flowering and fruit development at 0.077-0.121 lb
ai/A/application, at RTIs of 3-6 days, for totals of 0.414-0.463 lb
ai/A/season (~1x rate).  All applications were made using ground
equipment at 20-45 GPA, without the use of any adjuvants.  Duplicate
control and treated samples of mature cucumbers were harvested from each
site at 3 DALA (proposed PHI), and additional samples were collected at
1, 6 and 12 DALA at two sites to assess residue decline.  Samples were
stored frozen up to 697 days prior to extraction for analysis, an
interval supported by available concurrent storage stability data.
Samples were analyzed for combined indoxacarb residues using an adequate
LC/MS/MS method, which is a modified version of a tolerance enforcement
(HPLC/UV Method AMR 2712-93).  The LLMV is 0.01 ppm, and the calculated
LOQ and LOD are 0.011 and 0.004 ppm, respectively.

Following four applications at a total rate of 0.414-0.463 lb ai/A (1x
rate), combined residues were <0.01-0.069 ppm in/on 20 samples of
cucumbers harvested at 3 DALA.  Average residues were 0.022 ppm, and
HAFT residues were 0.055 ppm.  In the two residue decline trials,
average residues declined steadily from 0.028 ppm at 1 DALA to <0.01 ppm
by 12 DALA.

Summer Squash.  In 12 field trials conducted in the U.S. and Canada
during 2003, indoxacarb (30% WDG) was applied to summer squash as either
four (11 trials) or five (1 trial) broadcast foliar applications during
flowering and fruit development at 0.103-0.119 lb ai/A/application, at
RTIs of 4-7 days, for total application rates of 0.423-0.459 lb ai/A (1x
rate) or 0.541 lb ai/A (1.2x rate).  All applications were made using
ground equipment at 20-41 GPA, without the use of any adjuvants.  Single
control and duplicate treated samples of mature squash were harvested
from each site at 2-4 DALA; the proposed PHI is 3 days.   Samples were
stored frozen up to 301 days prior to extraction for analysis, an
interval supported by available concurrent storage stability data.
Samples were analyzed for the combined indoxacarb residues using an
HPLC/UV method, which is a modified version of a tolerance enforcement
method (Method AMR 2712-93). The LLMV was 0.01 ppm, and the calculated
LOQ and LOD were 0.014 and 0.005 ppm, respectively.

Following four applications at a total rate of 0.423-0.459 lb ai/A the
1x rate, residues were <0.01-0.120 ppm in/on 22 samples of squash
harvested at 2-4 DALA.  The HAFT residues were 0.102 ppm and average
residues were 0.032 ppm.  For the one trial at the 1.2x rate, residues
were <0.01 ppm in/on both samples harvested at 3 DALA.

Pome fruits (group 11, except pear).  Acceptable field trial data are
available supporting the use of indoxacarb (30% WDG) on apples (Memo, S.
Levy, 19-JAN-2000; DP#: 244253).  As apple is the representative crop
for group 11 (except pear) and the proposed use is identical to the
existing use on apples, the apple field trial data will support the
expanded use of indoxacarb (30% WDG) on pome fruits, except pear.

Stone Fruits (group 12)

Cherry.  In 16 field trials conducted in the U.S. and Canada during
2002-2004, indoxacarb (30% WDG) was applied to sweet (4 trials) and tart
(12 trials) cherries as four foliar applications during fruit
development at 0.106-0.118 lb ai/A/application, at RTIs of 6-10 days,
for total application rates of 0.437-0.468 lb ai/A (1x rate).  All
applications were made using ground equipment at 80-129 GPA, without the
use of any adjuvants.  Duplicate control and treated samples of cherries
were harvested at 12-14 DALA, except in one trial where samples were
harvested at 5 DALA.   Samples were stored frozen up to 315 days prior
to extraction for analysis, an interval supported by the available
concurrent storage stability data.  Samples were analyzed for the
combined indoxacarb residues using a modified version of an HPLC/UV
method (Method AMR 2712-93). The LLMV was 0.02 ppm, and the calculated
LOQ and LOD were 0.007 and 0.002 ppm, respectively.

Following four foliar applications at a total rate of 0.437-0.468 lb
ai/A (1x rate), combined residues were 0.07-0.64 ppm in/on sweet and
tart cherries harvested at 12-14 DALA, and the two samples harvested at
5-DALA had similar residues (0.45 ppm).  The HAFT residues were 0.63 ppm
and average residues were 0.25 ppm.

Peach.  In 16 field trials conducted in the U.S. and Canada during 2003,
indoxacarb (30% WDG) was applied to peaches as four or five (1 trial)
foliar applications during fruit development at 0.105-0.113 lb
ai/A/application, at RTIs of typically 6-7 days.  Total application
rates were 0.420-0.449 lb ai/A in 15 trials (1x rate) and 0.55 lb ai/A
(1.3x rate) in one trial.  All applications were made using ground
equipment at 48-141 GPA, without the use of any adjuvants.  Duplicate
control and treated samples of peaches were harvested at 13-15 DALA,
except in one trial where samples were harvested at 7 DALA.  Samples
were stored frozen up to 119 days prior to extraction for analysis, an
interval supported by the available concurrent storage stability data.
Samples were analyzed for the combined residues of indoxacarb + its
R-enantiomer using a modified version of an HPLC/UV method (Method AMR
2712-93).  The LLMV was 0.01 ppm, and the calculated LOQ and LOD were
0.003 and 0.001 ppm, respectively.

Following four foliar applications at a total rate of 0.420-0.449 lb
ai/A (1x rate), combined residues were 0.03-0.59 ppm in/on 28 samples of
 peaches harvested at 13-14 DALA, and the two samples harvested at
7-DALA had similar residues (0.07 ppm).  The HAFT residues were 0.59 ppm
and average residues were 0.16 ppm.  For the field trial conducted at
0.55 lb ai/A/season (1.3x rate), residues at 15 DALA were similar (0.48
and 0.58 ppm) to the other trials.

Plum.  In 11 field trials conducted in the U.S. and Canada during 2003,
indoxacarb (30% WDG) was applied to plums as four foliar applications
during fruit development at 0.106-0.114 lb ai/A/application, at RTIs of
typically 6-9 days, for totals of 0.431-0.448 lb ai/A (1x rate).  All
applications were made using ground equipment at 59-141 GPA, without the
use of any adjuvants.  Duplicate control and treated samples of plums
were harvested from each trial at 13-15 DALA, and samples were stored
frozen up to 155 days prior to extraction for analysis, an interval
supported by the available concurrent storage stability data.  Samples
were analyzed for the combined indoxacarb residues using a modified
version of an HPLC/UV method (Method AMR 2712-93).  The LLMV was 0.01
ppm, and the calculated LOQ and LOD were 0.008 and 0.003 ppm,
respectively.

Following four foliar applications at a total rate of 0.431-0.448 lb
ai/A (1x rate), combined residues were <0.01-0.19 ppm in/on 22 samples
of plums harvested at 13-15 DALA.  The HAFT residues were 0.185 ppm and
average residues were 0.045 ppm.

Miscellaneous Crops

Cranberry.  In six field trials conducted in the U.S. during 2002-2003,
indoxacarb (30% WDG) was applied to cranberries as four broadcast foliar
applications during fruit development at 0.108-0.115 lb
ai/A/application, at RTIs of 6-8 days, for a total application rate of
0.436-0.451 lb ai/A (1x rate).  All applications were made using ground
equipment at 28-46 GPA, without the use of any adjuvants.  Duplicate
control and treated samples of cranberries were harvested twice from
each trial, at 13-15 and 28-30 DALA; the proposed PHI is 30 days.
Samples were stored frozen up to 45 days prior to extraction for
analysis, an interval supported by the available concurrent storage
stability data.  Samples were analyzed for combined indoxacarb residues
using an adequate GC/MSD method (AMR-3493-95).  The LLMV was 0.05 ppm,
and the calculated LOQ and LOD were 0.019 and 0.003 ppm, respectively.

Following four foliar applications at a total rate of 0.436-0.451 lb
ai/A (1x rate), combined indoxacarb residues in/on cranberries were
0.11-0.39 ppm at 13-15 DALA and 0.086-0.69 at 28-30 DALA.  Average
residues were 0.23 and 0.22 ppm at the first and second harvest
intervals, respectively; and the HAFT residues were 0.32 and 0.63 ppm.
Residue levels declined at the later harvest interval in four trials,
remained relatively unchanged in one trial, and increased in one trial.

Mint.  In six field trials conducted in the growing Zones 5 and 11
during 2002, indoxacarb (30% WDG) was applied to mint as four broadcast
foliar applications during crop development at 0.062-0.070 lb
ai/A/application, at RTIs of 2-4 days, for a total application rate of
0.260-0.270 lb ai/A (1x rate).  All applications were made using ground
equipment at 20-46 GPA, without the use of any adjuvants.  Duplicate
control and treated samples of commercially mature mint tops were
harvested from each trial at 7 or 8 DALA, and samples were stored frozen
up to 4.6 months prior to extraction for analysis, an interval supported
by the available concurrent storage stability data.  Mint samples were
analyzed for combined indoxacarb residues using an adequate GC/MSD
method (AMR-3493-95). The LLMV was 0.05 ppm, and the calculated LOQ and
LOD were 0.053 and 0.018 ppm, respectively.

Following four applications at a total rate of 0.260-0.270 (1x rate),
residues were 2.10-6.84 ppm in/on 12 samples of mint harvested at 7-8
DALA.  The HAFT residues were 6.37 ppm, and average residues were 3.87
ppm.  No residue decline trial was conducted.

Southern Pea.  In seven field trials conducted in growing Zones 2, 5 and
10 during 2002, indoxacarb (30% WDG) was applied to southern peas as
four broadcast foliar applications during pod development and maturation
at 0.063-0.067 lb ai/A/application, at RTIs of 2-4 days, for a total
rates of 0.255-0.266 lb ai/A (1x rate).  All applications were made
using ground equipment at 29-79 GPA, without the use of any adjuvants.
Duplicate control and treated samples of “mature seed” were
harvested from each trial at 6-7 DALA.  However, the study did not
indicate whether “mature seed” samples were dry seed or succulent
seed.  Samples were stored frozen up to 8.5 months prior to extraction
for analysis, an interval supported by available concurrent storage
stability data.  Samples were analyzed using a modified version of a
HPLC/UV tolerance enforcement method (Method AMR 2712-93).  The lowest
limit of method validation (LLMV) was 0.01 ppm, and the calculated LOQ
and LOD were 0.009 and 0.003 ppm, respectively.

Following four applications at total rates of 0.255-0.266 lb ai/A (1x
rate), combined indoxacarb residues were <0.01-0.067 ppm in/on 14
samples of southern pea seeds harvested at 6-7 DALA.  The HAFT residues
were 0.065 ppm and average residues were 0.021 ppm.

Okra.  Field trial data are not available for indoxacarb on okra.
However, IR-4 has requested that previously-reviewed bell and non-bell
pepper field trial data (Memo, S. Levy, 19-JAN-2000; DP#: 244253) with
the same use pattern be used to support the proposed use on okra for the
following reasons:  i) the growth habit and stage of maturity at
commercial harvest is similar for okra and non-bell type peppers, ii)
the major growing zones for peppers including the major growing zones
for okra, and iii) the proposed use pattern on okra is identical to the
existing use on peppers.

  SEQ CHAPTER \h \r 1 Conclusions.  The submitted field trial data on
spinach, cantaloupes, cucumbers, summer squash, cherries, peaches,
plums, cranberries, and mint are adequate and support the proposed use
patterns for indoxacarb (30% WDG) on these crops or crop groups.  The
number and geographic distribution of the field trials are adequate, and
the appropriate samples were collected at the proposed PHIs.  The
samples were analyzed using adequate analytical methods and the sample
storage intervals are supported by the available storage stability data.

The southern pea field trial data are also adequate; however, the
petitioner did not specify if they wanted succulent or dry.  The field
trial data submitted were for dry peas.  The proposed label directions
for southern peas should be amended to allow for applications only to
varieties used to produce dry seed.  If the petitioner intends to
support a generalized use on southern peas, then field trials will be
required for succulent varieties as well.

Acceptable field trial data are also available to support existing uses
of indoxacarb (30% WDG) on potatoes, leaf and head lettuce, apples and
peppers (Memos, S. Levy, 19-JAN-2000; DP#: 244253; and 30-MAY-2002; DP#:
276516).  These data on the representative crops of potatoes, lettuce,
and apples will support expanding the use of indoxacarb (WDG) to cover
similar uses on tuberous and corm vegetables (subgroup 1C), vegetable,
leafy, except Brassica, group 4, and pome fruit (group 11, except pear).

The residue data on tomatoes and peppers can be translated to support
the same use pattern for indoxacarb (WDG) on okra, as there is already a
crop group tolerance established on “vegetable, fruiting, group 8”
and okra is now considered part of the “vegetable, fruiting, group
8” crop group.

The available field trial data on celery (the representative crop for
subgroup 4B) would not be adequate to support a subgroup tolerance, as
only six field trials were conducted using the WDG formulation, rather
than the required eight field trials, but are adequate to support a crop
group tolerance for the crop group vegetable, leafy, except Brassica
(group 4).

860.1520 Processed Food and Feed

  SEQ CHAPTER \h \r 1

46520902.der2 (mint)

46651506.der2 (plum/prune)

Apple and Potato.  The proposed uses on pome fruits and tuberous and
corm vegetables include apples and potatoes.  Processing studies on
apples and potatoes were previously evaluated under earlier petitions
(Memos, S. Levy, 19-JAN-2000; DP# 244253 and 30-MAY-2002; DP#: 276516).
Based on these petitions, no tolerances were required for potato
processed products and a 3.0 ppm tolerance was established for wet apple
pomace.

Mint.  In two field trials conducted in 2002, indoxacarb (30% WDG) was
applied to mint as four broadcast foliar applications during crop
development at 0.062-0.067 lb ai/A/application, at RTIs of 2-4 days, for
a total of 0.260 lb ai/A (1x rate).  Applications were made using ground
equipment at 24-46 GPA, without the use of any adjuvants.  Duplicate
control and treated samples of commercially mature mint tops were
harvested from each trial at 7 or 8 DALA, along with single bulk control
and treated samples used for processing.  The bulk samples of tops were
distilled using simulated commercial procedures to yield mint oil.
Samples of mint tops and oil were stored frozen up to 5.4 months prior
to extraction for analysis, an interval supported by the available
concurrent storage stability data.  Samples of mint tops and oil were
analyzed for the combined indoxacarb residues using a GC/MSD method
(AMR-3493-95), which is an approved tolerance enforcement method.  The
LLMV was 0.05 ppm for tops and 0.1 ppm for oil.  The calculated LOQ and
LOD were respectively 0.053 and 0.018 ppm for tops, and 0.11 and 0.037
ppm for oil.

Residues averaged 2.49 and 6.06 ppm in/on fresh mint hay harvested at
7-8 DALA from the two field trials, and residues in mint oil were <0.1
ppm for both trials.  The processing factor for mint oil was 0.017x and
0.04x for the two trials and averaged 0.028x.

Plums/prunes.  In a field trial conducted during 2003 in CA, indoxacarb
(30% WDG) was applied to plum trees as four foliar applications during
fruit development at 0.109-0.111 lb ai/A/application, at RTIs of 7 days,
for a total of 0.440 lb ai/A/season (1x rate).  Single bulk samples of
control and treated plums were harvested at commercial maturity, at 14
DALA.   Following harvest, plums were dried to prunes using simulated
commercial procedures.  Prior to analysis, plums and prunes were stored
frozen up to 155 and 189 days, respectively, an interval supported by
the available concurrent storage stability data.  Samples were analyzed
for the combined indoxacarb residues using a modified version of an
HPLC/UV method (Method AMR 2712-93).   The LLMV was 0.01 ppm for both
plum and prunes.  For plums and prunes, respectively, the calculated
LOQs were 0.008 and 0.003 ppm, and the LODs were 0.003 and 0.001 ppm.

Residues were 0.01 ppm in/on plums harvested at 14 DALA, and 0.04 ppm
in/on prunes processed from fresh plums.  Residues concentrated in
prunes by 4x, which is slightly higher than the 3.5x theoretical
concentration factors based on water loss.

  SEQ CHAPTER \h \r 1 Conclusions.  The available mint and plum
processing studies are adequate.  As indoxacarb residues were reduced on
average by 0.028x in mint oil, a separate tolerance is not required for
mint oil.  Residues concentrated by 4x in prunes, which is higher than
the theoretical concentration factor of 3.5x.  However, based on HAFT
residues of 0.185 ppm for plums, the maximum expected residues in prunes
would be 0.74 ppm, which is below the recommended tolerance for stone
fruits (0.90 ppm).  Therefore a separate tolerance is not required for
prunes.

860.1650 Submittal of Analytical Reference Standards

As of AUG-2006, an analytical reference standard for indoxacarb is
available at the EPA National Pesticide Standards Repository.

860.1850/860.1900 Confined and Field Accumulation in Rotational Crops

An adequate confined rotational crop study was reviewed in conjunction
with an earlier petition (PP#8F04948, S. Levy, 19-JAN-2000; DP#:
244253), and the MARC concluded that the residues of concern in rotated
crops include parent only (Memo, S. Levy, 10-JUL-2000; DP#: 263986).
Based on the confined study, HED has also concluded that the available
data support a 30-day plant-back interval (PBI) for all non-labeled
crops (Memo, S. Levy, 07-SEP-2000; DP#: 256351).

860.1550 Proposed Tolerances

The MARC has determined that the tolerance expression for plants should
include parent only, which includes indoxacarb + its R-enantiomer.
Permanent tolerances are currently established for the combined residues
of indoxacarb + its inactive R-enantiomer in/on various plant
commodities at levels ranging from 0.01 ppm in/on peanuts and potatoes
to 50 ppm in/on alfalfa hay [40 CFR §180.564(a)].  Tolerances are also
established for livestock commodities; however, livestock tolerances are
not addressed in this petition as the proposed uses do not include any
new uses on crops having livestock feed items.   SEQ CHAPTER \h \r 1

The tolerances proposed by the petitioner are listed below in Table 5,
along with the HED’s recommended tolerance levels.    SEQ CHAPTER \h
\r 1 The recommended tolerance levels for each RAC or crop group in the
current petitions were determined using recent Agency Guidance (Guidance
for Setting Pesticide Tolerances Based on Field Trial Data SOP).  For
southern peas, the recommended tolerance was based on the observed
maximum residue value.  For those commodities for which the tolerance
spreadsheet was used to calculate the appropriate tolerance level, the
residue data used for the tolerance calculations and the supporting
spreadsheet outputs are presented in Appendix II.

For purposes of determining tolerances, adequate field trial data are
available to set individual tolerances on southern peas, cranberries,
and mint.  In addition, the available data on cantaloupes, cucumbers,
and squash will support a crop group tolerance on cucurbit vegetables,
and the available data on cherries, peaches and plums will support a
crop group tolerance on stone fruits.  As residues were highest in
cantaloupes and cherries, these data were used to set tolerances for
their respective crop groups.

Based on previously reviewed field trial data supporting the existing
tolerances on leaf and head lettuce (10 and 5.0 ppm, respectively) and
the currently-submitted spinach and celery data, a new crop group
tolerance can be established at 14 ppm for “vegetable, leafy, except
Brassica, group 4.”  As residues were highest in spinach, these data
were used to set the crop group tolerance.

Based on previously reviewed field trial data supporting the existing
tolerances on potatoes and apples, new tolerances can be established at
the same levels on tuberous and corm vegetables (subgroup 1C) and pome
fruit (group 11, except pear).  The existing pear tolerance (0.20 ppm)
can be translated to pear, oriental.  In addition, the residue data on
peppers can be translated to support the same use pattern for indoxacarb
(WDG) on okra, as okra is now considered part of the “vegetable,
fruiting, group 8” crop group.

Based on the mint and plum processing studies, separate tolerances are
not required for either mint oil or prunes.  Residues were reduced in
mint oil by 0.028x.  Although residues concentrated in prunes by 4x, the
maximum expected residues in prunes would be 0.74 ppm, which is below
the recommended tolerance for stone fruits (0.90 ppm).

  SEQ CHAPTER \h \r 1 There are no established or proposed Codex or
Canadian maximum residue limits (MRLs) for indoxacarb.  However, Mexico
has established MRLs for indoxacarb on several crops at levels ranging
from 0.5 mg/kg on tomatoes and pepper to 10 mg/kg on corn (Appendix I).
None of the proposed tolerances currently have equivalent Mexican MRLs,
therefore, there are no international harmonization issues associated
with these petitions.

Table 5.  Tolerance Summary for Indoxacarb.

Crop Commodity	Proposed or Existing Tolerance (ppm)	Recommended
Tolerance

 (ppm)	Comments

(Corrected commodity definition)

Cranberry	1	0.901	Adequate residue data are available.

Fruit, pome, except pear, group 11	1.0	1.02	The existing residue data on
apples are adequate and will support an expanded use and a tolerance on
Fruit, pome, group 11, except pear.

Pear, oriental	--	0.202	The existing pear tolerance can be translated to
set a separate Pear, oriental tolerance.

Apple	1.0	Delete	Once the tolerance is established on group 11, the
separate tolerance on apple should be deleted.

Fruit, stone group 12	1	0.901	Adequate residue data are available on
cherries, plums and peaches.  The group tolerance is based on residue
data from cherries.  Fruit, stone, group 12

Leafy vegetables except Brassica	14	141	The existing residue data on
leaf and head lettuce are adequate, as well as the currently- submitted
spinach and celery data will support a crop group tolerance for
Vegetable, Leafy, Except Brassica, Group 4.

Lettuce, head	5.0	Delete	Once the tolerance is established on Vegetable,
Leafy, except Brassica, Group 4, the separate tolerances on leaf and
head lettuce should be deleted.

Lettuce, Leaf	10.0

Mint 	10	111	Adequate residue data are available.

Separate tolerances should be established for Peppermint and Spearmint.

Okra	0.5	0.502	The existing residue data on tomatoes and  peppers will
be translated to support the same use pattern and tolerance on okra, as
okra is now considered part of the “vegetable, fruiting, group 8”
crop group.

Pea (southern)	0.1	0.101	Adequate residue data are available for dried
pea only.

Pea, southern, seed

Vegetable, cucurbit, group 9	0.5	0.601	Adequate residue data are
available on cucumbers, squash, and cantaloupes.  The tolerance is based
on residue data from cantaloupes.

Vegetable, tuberous and corm, subgroup 1C	0.01	0.012	The existing
residue data on potatoes are adequate and will support an expanded use
and a tolerance on Vegetable, tuberous and corm, subgroup 1C.

Potato	0.01	Delete	Once the tolerance is established on subgroup 1C, the
separate tolerance on potato should be deleted.

1	Tolerance was determined using tolerance calculating spread sheet (see
Appendix II).

2	Tolerance is based on translation of existing residue data.

  SEQ CHAPTER \h \r 1 Attachments

Appendix I - International Residue Limits Status

Appendix II -Tolerance Assessment Calculations

cc:  S. Levy (RAB1)

RDI:  RAB1 Chemists (21-FEB-2007), G.F. Kramer (09-MAR-2007)

S. Levy: S10953:PY-S:(703)-305-0783:7509P:RAB1

Template Version September 2005

References

DP#:	260953

Subject:	PP# 8F04948.  Multiresidue Method Testing of DPX-JW062.

From:	S. Levy

To:	F. Griffith

Dated:	03-NOV-1999

MRID#:	44477340

DP#s:	244253, 244460, 245424, 248057

Subject:	PP#8F04948. New Chemical - Indoxacarb (DPX-MP062) in/on
Brassica, Sweet Corn, Cotton, Fruiting Vegetables, Lettuce (Head and
Leaf) and Pome Fruits. Evaluation of Residue Data and Analytical
Methods.

From:	S. Levy/S. Chun

To:	D.Peacock/A. Layne

Dated:	19-JAN-2000

MRID#s:	44477101-44477112, 44477317, 44477318, 44477321-44477344,
44477401-44477417, 44583301, 44815204 44815801-44815803,
44815805-44815808, 44491704.

DP#:	263986

Subject:	Results of HED Metabolism Assessment Review Committee (MARC)
Meeting of 6/12/00.  Indoxacarb (DPX-MP062).  PP#8F04948.

From:	S. Levy/M. Copley

To:	G. Kramer

Dated:	10-JUL-2000

MRID#:	None

DP#s:	256351 and 256354

Subject:	Indoxacarb (DPX-MP062).  Additional Data to Amend HED's Residue
Data and Analytical Methods in/on Brassica, Sweet Corn, Cotton, Fruiting
Vegetables, Lettuce (Head and Leaf) and Pome Fruits Memorandum (D267325,
S. Levy, 1-Jan-2000) and Response to Petitioner’s Proposal to Lower
Plant-back Intervals for Non-Labeled Crops.

From:	S. Levy

To:	D.Peacock/A. Layne

Dated:	07-SEP-2000

MRID:	44815801-44815808

DP#:	267339

Subject:	Memo to Mark Wirtz of FDA regarding Enforcement Methods for
Plant and Animal Commodities.

From:	S. Levy

To:	M. Wirtz

Dated:	12-OCT-2000

MRID#s:	44477330-4477332, 44491704, 44477327, and 44477338

DP#:	277922

Subject:	Indoxacarb:  Results of Health Effects Division (HED)
Metabolism Assessment Review Committee (MARC) Meeting of 9/18/01. PP#:
000352-00594.

From:	S. Levy/J. Kidwell

To:	Y. Donovan

Dated:	04-OCT-2001

MRID#:	None

DP#:	282821

Subject:	Memo to Mark Wirtz of FDA regarding Enforcement Method for
Indoxacarb.

From:	S. Levy

To:	M. Wirtz

Dated:	09-MAY-2002

MRID#:	45384306

  SEQ CHAPTER \h \r 1 DP#s:	276516, 276518, 276541 and 278090

Subject:	PP# 1F06301.  Indoxacarb in/on Alfalfa, Lettuce, Peanut,
Potato, and Soybean.  Evaluation of Residue Data and Analytical Methods.

From:	S. Levy

To:	G. McCann and M. Laws

Dated:	30-MAY-2002

MRID#s:	  SEQ CHAPTER \h \r 1 45384301-45384310

  SEQ CHAPTER \h \r 1 DP#s:	290172

Subject:	Indoxacarb.  Review of Amendment Submitted in Response to
HED’s Memorandums of 19-JAN-2000 and 07

From:	S. Levy

To:	R. Kumar/D. Kenny

Dated:	14-APR-2004

MRID#s:	45795818 and 45795819  SEQ CHAPTER \h \r 1

  SEQ CHAPTER \h \r 1 DP#s:	276516, 276518, 276541 and 278090

Subject:	Indoxacarb.  Review of Amendment Submitted in Response to
HED’s Memorandum of 19-JAN-2000.

From:	S. Levy

To:	R. Kumar/D. Kenny

Dated:	22-SEP-2004

MRID#:	46114302  SEQ CHAPTER \h \r 1

  SEQ CHAPTER \h \r 1 DP#s:	290126 and 293792

Subject:	Indoxacarb in/on Grapes, Brassica Leafy Vegetables, and Turnip
Greens.  Summary of Analytical Chemistry and Residue Data.  Petition#s:
3F6576 and 2E6482.

From:	S. Levy

To:	A. Hanger

Dated:	18-FEB-2005

MRID#s:	45718701, 45718702, 45900301, and 45900303

DP#:	313518

Subject:	Memo to Mark Wirtz of FDA regarding Enforcement Methods for
Plant Commodities.

From:	S. Levy

To:	M. Wirtz

Dated:	18-FEB-2005

MRID#:	45900303

Appendix I.  International Residue Limit Status Sheet

INTERNATIONAL RESIDUE LIMIT STATUS

Chemical Name:

(S)-methyl 7-chloro-2,5-dihydro-2-[[(methoxycarbonyl)[4-(trifluoro
methoxy)phenyl]amino]carbonyl]
indeno[1,2-e][1,3,4]oxadiazine-4a(3H)-carboxylate	Common Name:
Indoxacarb

	X  Proposed tolerances

  Reevaluated tolerance

  Other	Date:  08-SEP-2006

Codex Status (Maximum Residue Limits)	U. S. Tolerances

X  No Codex proposal step 6 or above

  No Codex proposal step 6 or above for the crops requested
Petition#s:  5E6911, 5E6926, 5E6991

DP#s:  325479, 326516, 326544

Other Identifier:  DPX-MP062; DPX-JW062; DPX-KN128

Residue definition (step 8/CXL): N/A	Reviewer/Branch:  S. Levy, RAB1

	Residue definition:

Combined residues of indoxacarb + its R-enantiomer

Crop (s)	MRL (mg/kg)	Crop(s) 	Tolerance (ppm)

Cranberry	0.9

Fruit, pome, except pear, group 11	1.0

Fruit, stone, group 12	0.9

Leafy greens, except spinach, subgroup 4A	10

Leaf petioles subgroup 4B	4.5

Mint 	10

Okra	0.5

Pea, southern, seed	0.1

Spinach	14

Vegetable, cucurbit, group 9	0.6

Vegetable, tuberous and corm, subgroup 1C	0.01

Limits for Canada	Limits for Mexico

X  No Limits

  No Limits for the crops requested	  No Limits

X  No Limits for the crops requested

Residue definition:  N/A	Residue definition:  Indoxacarb

Crop(s)	MRL (mg/kg)	Crop(s)	MRL (mg/kg)

Broccoli	5

Brussels sprouts	5

Cabbage	5

Cauliflower	5

Corn	10

Cotton	2

Pepper	0.5

Tomato	0.5

Notes/Special Instructions:

Appendix II -Tolerance Assessment Calculations

The Agency’s Guidance for Setting Pesticide Tolerances Based on Field
Trial Data was utilized for determining appropriate tolerance levels on
southern peas, cucurbit vegetables, stone fruits, cranberries and mint.
Residue levels in these commodities were readily quantifiable, and with
the exception of peas, <10% of the residue values were below the LOQ.

The datasets used to establish tolerances consisted of field trial data
representing applications of the appropriate formulation (WDG) at ~1x
maximum proposed maximum use rates.  As specified by the Guidance for
Setting Pesticide Tolerances Based on Field Trial Data SOP, the field
trial application rates were within 25% of the maximum label application
rate, and the PHIs were consistent with the appropriate stage of
maturity and the proposed PHI for each commodity.  The residues values
used to calculate the tolerances are provided in Tables II-1 through
II-7.  As residues were highest in cantaloupes, cherries, and spinach,
the data on these crops were used to set tolerances for their respective
crop groups.

The datasets were entered into the tolerance spreadsheet and visual
inspection of the lognormal probability plots indicates that the
datasets are reasonably lognormal, and with the exceptions of the data
sets for southern pea and plums.  For the remaining commodities, the
results from the approximate Shapiro-Francia test statistic confirmed
that the assumption of lognormality should not be rejected.

The calculated tolerance levels are 0.60 ppm for vegetable, cucurbit,
group 9, 0.90 ppm for fruit, stone, group 12 and cranberry, 14 ppm for
vegetable, leafy, except Brassica, group 4, and 11 ppm for mint.

Table II-1.	Combined Indoxacarb Residue Data on Spinach.

Regulator:	EPA

Chemical:	Indoxacarb

Crop:	Spinach

PHI:	3 days	7 days	14 days

App. Rate:	0.268 lb ai/A

Submitter:	IR-4

MRID Citation:	MRID 46487001

	Combined Indoxacarb Residues

	7.9	4.3	2.2

	13	4.8	1.8

	2.5	2.2	1.1

	4.5	2.3	2.4

	3.7	3.0	2.2

	3.3	3.1	1.6

	5.7	4.7	0.3

	5.7	3.8	0.4

	4.7	1.2	2.2

	4.3	2.1	2.5

	4.3	2.8	2.0

	4.2	2.7	2.1

	7.2	4.3	1.3

	6.7	6.1	1.5

	2.2	0.5

4.4	2.6

Figure II-1.	Lognormal probability plot of indoxacarb (WDG) field trial
data for spinach at proposed 3-day PHI following four broadcast foliar
applications at 1x rate.

Figure II-2.	Tolerance spreadsheet summary of field trial data for
spinach at proposed 3-day PHI following four broadcast foliar
applications of indoxacarb (WDG).

Table II-2.	Combined Indoxacarb Residue Data on Celery.

Regulator:	EPA

Chemical:	Indoxacarb

Crop:	Celery (untrimmed stalks)

PHI:	7 days	14 days	21 days

App. Rate:	0.268 lb ai/A

Submitter:	IR-4

MRID Citation:	MRID 46487002

	Combined Indoxacarb Residues

	0.39	0.28	0.089

	0.38	0.14	0.055

	1.60	0.91	0.220

	1.80	1.00	0.770

	0.67	0.39	0.430

	1.60	0.37	0.340

	1.10	1.00	0.210

	1.30	0.98	0.240

	0.33	0.12	0.110

	0.32	0.15	0.190

	1.80	0.35	0.210

	1.60	0.37	0.210

Figure II-3.	Lognormal probability plot of indoxacarb (WDG) field trial
data for celery at proposed 14-day PHI following four broadcast foliar
applications at 1x rate.

Figure II-4.	Tolerance spreadsheet summary of field trial data for
celery at proposed 14-day PHI following four broadcast foliar
applications of indoxacarb (WDG).

Table II-3.	Combined Indoxacarb Residue Data on Southern Pea.

Regulator:	EPA

Chemical:	Indoxacarb

Crop:	Southern Pea

PHI:	6-7 days

App. Rate:	0.255-0.266 lb ai/A

Submitter:	IR-4

MRID Citation:	MRID 46520901

	Combined Indoxacarb Residues

	0.0052*

	0.0068*

	0.0080*

	0.0090*

	0.0670

	0.0630

	0.0130

	0.0140

	0.0110

	0.0110

	0.0330

	0.0200

	0.0150

	0.0320

* Fill-in Residues from MLE for Values = LOQ.

Figure II-5.	Lognormal probability plot of indoxacarb (WDG) field trial
data for southern peas following four broadcast foliar applications at
1x rate.

Figure II-6.	Tolerance spreadsheet summary of field trial data for
southern peas following four broadcast foliar applications of indoxacarb
(WDG).

Table II-4.	Combined Indoxacarb Residue Data on Cucurbit Vegetables.

Regulator:	EPA

Chemical:	Indoxacarb

Crop:	Cantaloupe	Cucumber	Squash

PHI:	3-4 days	3 days	2-4 days

App. Rate:	0.436-0.475 lb ai/A	0.414-0.463 lb ai/A	0.423-0.466 lb ai/A

Submitter:	IR-4	IR-4	IR-4

MRID Citation:	MRID 46651501	MRID 46651502	MRID 46651503

	Combined Indoxacarb Residues

	0.027	0.018	0.120

	0.247	0.015	0.014

	0.130	0.025	0.110

	0.393	0.025	0.040

	0.088	0.01	0.01

	0.031	0.023	0.022

	0.050	0.040	0.035

	0.036	0.031	0.012

	0.050	0.013	0.026

	0.116	0.019	0.01

	0.018	0.016	0.01

	0.064	0.020	0.084

	0.197	0.028	0.013

	0.170	0.014	0.048

	0.230	0.01	0.032

	0.068	0.022	0.01

	0.022	0.069	0.034

	0.064	0.031	0.026

	0.035	0.012	0.013

	0.052	0.018	0.028

	0.124

0.01

	0.024

0.022

Figure II-7.	Lognormal probability plot of indoxacarb (WDG) field trial
data for cantaloupes following four broadcast foliar applications at 1x
rate.

Figure II-8.	Tolerance spreadsheet summary of field trial data for
cantaloupes following four broadcast foliar applications of indoxacarb
(WDG).

Figure II-9.	Lognormal probability plot of indoxacarb (WDG) field trial
data for cucumbers following four broadcast foliar applications at 1x
rate.

Figure II-10.	Tolerance spreadsheet summary of field trial data for
cucumbers following four broadcast foliar applications of indoxacarb
(WDG).

Figure II-11.	Lognormal probability plot of indoxacarb (WDG) field
trial data for summer squash following four broadcast foliar
applications at 1x rate.

Figure II-12.	Tolerance spreadsheet summary of field trial data for
summer squash following four broadcast foliar applications of indoxacarb
(WDG).

Table II-5.	Combined Indoxacarb Residue Data on Stone Fruits.

Regulator:	EPA

Chemical:	Indoxacarb

Crop:	Cherry	Peach	Plum

PHI:	12-14 days	13-14 days	13-15 days

App. Rate:	0.437-0.456 lb ai/A	0.400-0.449 lb ai/A	0.431-0.448 lb ai/A

Submitter:	IR-4	IR-4	IR-4

MRID Citation:	MRID 46651504	MRID 46651505	MRID 46651506

	Combined Indoxacarb Residues

	0.07	0.07	0.0052*

	0.07	0.26	0.0068*

	0.15	0.13	0.02

	0.45	0.03	0.02

	0.22	0.04	0.02

	0.19	0.1	0.03

	0.15	0.09	0.07

	0.16	0.09	0.04

	0.3	0.1	0.07

	0.51	0.09	0.19

	0.24	0.3	0.02

	0.12	0.16	0.02

	0.26	0.19	0.01

	0.31	0.58	0.02

	0.13	0.07	0.02

	0.62	0.06	0.02

	0.07	0.29	0.03

	0.07	0.13	0.07

	0.15	0.04	0.04

	0.45	0.04	0.07

	0.21	0.1	0.18

	0.19	0.09	0.01

	0.15	0.1

0.15	0.1

0.32	0.09

0.51	0.3

0.28	0.16

0.15	0.2

0.26	0.59

0.32	0.07

0.13

	0.64

* Fill-in Residues from MLE for Values = LOQ.

Figure II-13.	Lognormal probability plot of indoxacarb (WDG) field
trial data for cherries following four foliar applications at 1x rate.

Figure II-14.	Tolerance spreadsheet summary of field trial data for
cherries following four foliar applications of indoxacarb (WDG).

Figure II-15.	Lognormal probability plot of indoxacarb (WDG) field
trial data for peaches following four foliar applications at 1x rate.

Figure II-16.	Tolerance spreadsheet summary of field trial data for
peaches following four foliar applications of indoxacarb (WDG).

Figure II-17.	Lognormal probability plot of indoxacarb (WDG) field
trial data for plums following four foliar applications at 1x rate.

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	preadsheet summary of field trial data for plums following four foliar
applications of indoxacarb (WDG).

Table II-6.	Combined Indoxacarb Residue Data on Cranberries.

Regulator:	EPA

Chemical:	Indoxacarb

Crop:	Cranberry

PHI:	13-15 days	28-30 days

App. Rate:	0.436-0.451 lb ai/A

Submitter:	IR-4

MRID Citation:	MRID 46651507

	Combined Indoxacarb Residues

	0.157	0.086

	0.170	0.151

	0.110	0.099

	0.360	0.190

	0.300	0.130

	0.390	0.570

	0.219	0.146

	0.213	0.149

	0.110	0.110

	0.280	0.160

	0.170	0.110

	0.230	0.690

Figure II-19.	Lognormal probability plot of indoxacarb (WDG) field
trial data for cranberries 28-30 days (proposed PHI) following four
foliar applications at 1x rate.

Figure II-20.	Tolerance spreadsheet summary of field trial data for
cranberries following four foliar applications of indoxacarb (WDG).

Table II-7.	Combined Indoxacarb Residue Data on Mint.

Regulator:	EPA

Chemical:	Indoxacarb

Crop:	Mint

PHI:	7-8 days

App. Rate:	0.26-0.27 lb ai/A

Submitter:	IR-4

MRID Citation:	MRID 46520902

	Combined Indoxacarb Residues

	6.84

	5.90

	5.30

	6.81

	3.61

	2.62

	2.24

	2.73

	2.18

	2.10

	2.75

	3.36

Figure II-21.	Lognormal probability plot of indoxacarb (WDG) field
trial data for mint following four broadcast foliar applications at 1x
rate.

Figure II-22.	Tolerance spreadsheet summary of field trial data for mint
following four broadcast foliar applications of indoxacarb (WDG).

Indoxacarb	Summary of Analytical Chemistry and Residue Data	DP#: 325479

	Page 	  PAGE  45  of   NUMPAGES  45

Page   PAGE  1 of   NUMPAGES  45


[Federal Register Volume 78, Number 39 (Wednesday, February 27, 2013)]
[Notices]
[Pages 13335-13336]
[FR Doc No: 2013-04493]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings 1

    Take notice that the Commission received the following electric
rate filings:

    Docket Numbers: ER11-2970-004.
    Applicants: Peetz Logan Interconnect, LLC.
    Description: Peetz Logan Interconnect, LLC to be effective 11/1/
2011.
    Filed Date: 2/19/13.
    Accession Number: 20130219-5184.
    Comments Due: 5 p.m. ET 3/12/13.

    Docket Numbers: ER13-957-000.
    Applicants: California Independent System Operator Corporation.
    Description: 2013-02-19 Price Consistency to be effective 5/1/2013.
    Filed Date: 2/19/13.
    Accession Number: 20130219-5175.
    Comments Due: 5 p.m. ET 3/12/13.

    Docket Numbers: ER13-958-000.
    Applicants: Sunpower Corporation.
    Description: Petition by SunPower Corporation for Limited Waiver of
certain California Independent System Operator Corporation L.L.C. Open
Access Transmission Tariff provisions of Appendix GG.
    Filed Date: 2/19/13.
    Accession Number: 20130219-5185.
    Comments Due: 5 p.m. ET 3/12/13.

    Docket Numbers: ER13-959-000.
    Applicants: Duke Energy Carolinas, LLC.
    Description: Formula Rate Filing (Various Corrections) to be
effective 7/2/2012.
    Filed Date: 2/20/13.
    Accession Number: 20130220-5025.
    Comments Due: 5 p.m. ET 3/13/13.

    Docket Numbers: ER13-960-000.
    Applicants: PJM Interconnection, L.L.C.
    Description: Notice of Cancellation of First Revised SA No. 2925 in
Docket No. ER12-520-000 to be effective 9/26/2012.
    Filed Date: 2/20/13.
    Accession Number: 20130220-5026.
    Comments Due: 5 p.m. ET 3/13/13.

    Docket Numbers: ER13-961-000.
    Applicants: PJM Interconnection, L.L.C.
    Description: Notice of Cancellation of Second Revised SA No. 2789
in Docket No. ER12-521-000 to be effective 9/26/2012.
    Filed Date: 2/20/13.
    Accession Number: 20130220-5027.
    Comments Due: 5 p.m. ET 3/13/13.

    Take notice that the Commission received the following electric
reliability filings:

    Docket Numbers: RR12-8-001.
    Applicants: North American Electric Reliability Corp.
    Description: Compliance Filing of the North American Electric
Reliability Corporation in Response to December 20, 2012 Commission
Order.
    Filed Date: 2/19/13.
    Accession Number: 20130219-5190.
    Comments Due: 5 p.m. ET 3/21/13.

    The filings are accessible in the Commission's eLibrary system by
clicking on the links or querying the docket number.
    Any person desiring to intervene or protest in any of the above
proceedings must file in accordance with Rules 211

and 214 of the Commission's Regulations (18 CFR 385.211 and 385.214) on
or before 5:00 p.m. Eastern time on the specified comment date.
Protests may be considered, but intervention is necessary to become a
party to the proceeding.
    eFiling is encouraged. More detailed information relating to filing
requirements, interventions, protests, service, and qualifying
facilities filings can be found at: http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other information, call<PHONE_NUMBER>
(toll free). For TTY, call<PHONE_NUMBER>.

    Dated: February 20, 2013.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2013-04493 Filed 2-26-13; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 86, Number 153 (Thursday, August 12, 2021)]
[Notices]
[Page 44445]
[FR Doc No: 2021-17154]

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

SECURITIES AND EXCHANGE COMMISSION

[SEC File No. 270-360, OMB Control No. 3235-0409]

Proposed Collection; Comment Request

Upon Written Request, Copies Available From: Securities and Exchange
Commission, Office of FOIA Services, 100 F Street NE, Washington, DC
20549-2736

Extension:
    Rules 17Ad-15

    Notice is hereby given that pursuant to the Paperwork Reduction Act
of 1995 (``PRA'') (44 U.S.C. 3501 et seq.), the Securities and Exchange
Commission (``Commission'') is soliciting comments on the existing
collection of information provided for in Rule 17Ad-15 (17 CFR
240.17Ad-15) (``Rule 17Ad-15'') under the Securities Exchange Act of
1934 (15 U.S.C. 78a et seq.) (``Exchange Act''). The Commission plans
to submit this existing collection of information to the Office of
Management and Budget (``OMB'') for extension and approval.
    Rule 17Ad-15 requires every registered transfer agent to establish
written standards for the acceptance of guarantees of securities
transfers from eligible guarantor institutions. Every registered
transfer agent is also required to establish procedures, including
written guidelines where appropriate, to ensure that the transfer agent
uses those standards to determine whether to accept or reject
guarantees from eligible guarantor institutions. In implementing these
requirements, the Commission's purpose is to ensure that registered
transfer agents treat eligible guarantor institutions equitably.
    Additionally, Rule 17Ad-15 requires every registered transfer agent
to make and maintain records in the event the transfer agent determines
to reject signature guarantees from eligible guarantor institutions.
Registered transfer agents' records must include, following the date of
rejection, a record of the rejected transfer, along with the reason for
rejection, the identification of the guarantor, and an indication
whether the guarantor failed to meet the transfer agent's guarantee
standards.
    Rule 17Ad-15 requires registered transfer agents to maintain these
records for a period of three years. The Commission designed these
mandatory recordkeeping requirements to assist the Commission and other
regulatory agencies with monitoring registered transfer agents and
ensuring compliance with the rule. This rule does not involve the
collection of confidential information.
    The Commission estimates that approximately 366 registered transfer
agents will spend a total of approximately 14,640 hours per year
complying with recordkeeping requirements of Rules 17Ad-15 (40 hours
per year per registered transfer agent).
    Written comments are invited on: (a) Whether the proposed
collection of information is necessary for the proper performance of
the functions of the Commission, including whether the information
shall have practical utility; (b) the accuracy of the Commission's
estimates of the burden of the proposed collection of information; (c)
ways to enhance the quality, utility, and clarity of the information
collected; and (d) ways to minimize the burden of the collection of
information on respondents, including through the use of automated
collection techniques or other forms of information technology.
Consideration will be given to comments and suggestions submitted in
writing within 60 days of this publication.
    An agency may not conduct or sponsor, and a person is not required
to respond to, a collection of information under the PRA unless it
displays a currently valid OMB control number.
    Please direct your written comments to: (ii) David Bottom,
Director/Chief Information Officer, Securities and Exchange Commission,
c/o Cynthia Roscoe, 100 F Street NE, Washington, DC 20549, or send
email to<EMAIL_ADDRESS>
    Dated: August 6, 2021.
J. Matthew DeLesDernier,
Assistant Secretary.
[FR Doc. 2021-17154 Filed 8-11-21; 8:45 am]
BILLING CODE 8011-01-P


TO:	John Bradfield, U.S. EPA/OAQPS/SPPD  -  Natural Resources Group

FROM:	Eastern Research Group, Inc.

DATE:	February 8, 2017
--------------------------------------------------------------------------------

--------------------------------------------------------------------------------
SUBJECT:	February 2, 2017 Meeting Between the EPA and AB Mauri on the Proposed Nutritional Yeast Manufacturing Risk and Technology Review, Docket ID: EPA-HQ-OAR-2015-0730

Summary
AB Mauri participated in a meeting with the EPA on February 2, 2017, to discuss the proposed rule revision of removing brew ethanol monitoring from the Nutritional Yeast NESHAP (40 CFR, part 63, subpart CCCC). This memo presents the participants, agenda, and summary of the meeting.

Participants
 John Bradfield, EPA
 Bill Schrock, EPA
 Robin Dunkins, EPA
 Nora Greenglass, EPA
 Marguerite McLamb, EPA
 James Parker, AB Mauri - VP of the Fermentation Process
 Bryan Keyt, Bryan Cave LLC - AB Mauri Counsel
 Brandon Long, ERG
 James Chesnut, ERG

Agenda
AB Mauri provided the following questions to EPA:
Brew Ethanol Monitoring
 Would EPA explain the significance of removing the previous acknowledgement that the brew ethanol monitoring represented a parametric CEMS?
 Would EPA expand on the circumstances, information and/or incidents that led to its proposal to remove brew ethanol monitoring as a compliance methodology? Two yeast manufacturers are currently using this method in various forms.
 In EPA-HQ-OAR-2015-0730-0004, would EPA explain:
 Why a brew ethanol concentration at "the higher end of the range" was used to generate data for Table 2, rather than the brew ethanol average (BAE)?
 Why the black dashed lines in Figures 1, 2 and 3 which are to represent the emissions limits for each stage, are not at the actual limits for each stage.
 Figure 1 has the dashed line at approximately 270 ppm, rather than 300 ppm.
 Figure 2 has the dashed line at approximately 175 ppm, rather than 200 ppm.
 Figure 3 has the dashed line at 85 ppm, rather than at 100 ppm.
 In the proposed rule, AB Mauri would have to purchase and install an alternative to brew ethanol monitoring at both a considerable capital and increased operating expense.
 What additional data is EPA seeking to justify the continued use of brew ethanol monitoring, and how will it affect final rule (81 Fed Reg 95828)?
 Under what circumstances would EPA continue to allow the use of brew ethanol monitoring?
 Would EPA clarify the expected capital costs detailed in Table 2-1 of EPA-HQ-OAR-2015 - 0730-0005? Does the cost estimate cover installation of CEMS for one fermenter or seven fermenters?
 Would EPA provide the actual CEMS Cost Model  -  3/07/07 used to estimate the costs detailed for AB Mauri?
 In the proposed rule, while all yeast manufacturers subject to the rule would have RATA expenses, only AB Mauri has the potential for up front capital costs and an increase in CEMS costs. As the EPA has asked for comment associated with the continued use of brew ethanol monitoring, how will EPA distinguish comments from commenters which could be given from an anti-competitive, rather than scientific or legal basis?
 In working with the ABA, it is clear that all manufacturing plants experience significant issues with their FID CEMS and some have expressed interest in changing to alternate technologies. Will EPA consider alternative monitoring devices or methods? What is the process or methodology for approval? What is the timeframe for such approval?
 Should EPA conclude that brew ethanol monitoring must be replaced with an alternative CEMS, will EPA allow additional time above the one year proposed for AB Mauri to evaluate potential monitoring equipment, test potentially viable options and then purchase, install, validate and train personnel on the chosen equipment and methodology?

Specialty Yeast
 EPA comments that it recognizes that the yeast manufacturing industry is evolving and specialty yeast production has increased.
 Does EPA intend to update the definitions of the nutritional yeast category and the exclusion for specialty yeast to ensure that local regulators are uniformly applying the exclusions to reporting to all regulated sites?

Request for Extension of Comment Period
 AB Mauri is requesting a 60-day extension of the comment period to allow for necessary and appropriate technical analysis and evaluation of the impacts of the proposed rule.

Summary
 Where applicable, EPA provided clarifications to the administrative record filed in the docket for the proposed rule.
 A revised Brew Ethanol memo (EPA-HQ-OAR-2015-0730-0004) and Cost memo (EPA-HQ-OAR-2015-0730-0005) will be posted to the docket.