![](media/image1.png){width="0.7993055555555556in" height="0.8in"}

**UNITED STATES ENVIRONMENTAL PROTECTION AGENCY**

WASHINGTON, D.C. 20460

OFFICE OF

PREVENTION, PESTICIDES

AND TOXIC SUBSTANCES

**[MEMORANDUM]{.underline}**

Date: 20/NOV/2007

Subject: Flumioxazin. Petitions for Tolerances on Alfalfa, Asparagus,
Dry Beans, Fruiting Vegetables (Group 8, including Okra), Melons
(subgroup 9A), Bushberries (subgroup 13B), and Tree Nuts (group 14), and
a Request for an Amended Use on Garlic. Summary of Analytical Chemistry
and Residue Data. PP#s: 6F7092 and 6E7151.

  ------------- -------------------- ------------- ---------------------------
  DP Number:    342963               Decision      372752
                                     Number:       

  PC Code:      129034               MRID          46889603, 46889604,
                                     Numbers::     47005101, 47005102,
                                                   47005103, 47005104,
                                                   47005105, 47005106,
                                                   47005107

  40 CFR §180.  568                                

  Chemical      N-phenylpthalimide                 
  Class:        derivative herbicide               
  ------------- -------------------- ------------- ---------------------------

From: Debra Rate

Alternative Risk Integration and Assessment (ARIA)

Risk Integration, Minor Use, and Emergency Response Branch (RIMUERB)

Registration Division (RD) (7505P)

Through: William Cutchin, Acting Senior Branch Scientist

ARIA

RIMUERB/RD (7505P)

> William T. Drew, Chemist

Registration Action Branch 2 (RAB2)

Health Effects Division (HED) (7509P)

To: Daniel Rosenblatt, Branch Chief

RIMUERB/RD (7505P)

Joanne Miller / James Stone

Herbicide Branch (HB)/RD (7505P)

This document was originally prepared under contract by Dynamac
Corporation (submitted 25/MAY/2007). The document has been reviewed by
the ARIA team of the RIMUERB/RD and revised to reflect current Office of
Pesticide Programs (OPP) policies.

# Executive Summary

Flumioxazin is an N-phenylphthalimide class herbicide (Group 14) that is
currently used for pre- and post-emergence control of susceptible weeds
in a variety of fruit, vegetable and field crops. Tolerances are
currently established for residues of flumioxazin, with CAS number
103361-09-7, and IUPAC name
*N*-(7-fluoro-3,4-dihydro-3-oxo-4-prop-2-ynyl-2*H*-1,4-benzoxazin-6-yl)cyclohex-1-ene-1,2-dicarboxamide,
in/on various plant commodities at levels ranging from 0.02 to 0.70 ppm
(40 CFR §180.568\[a\]). Additionally, temporary tolerances are
established on alfalfa forage and hay at 0.13 and 0.45 ppm, respectively
(Expiration date 31/DEC/2009).

Valent U.S.A Corporation (Valent) and Interregional Research Project No.
4 (IR-4) have submitted petitions supporting the use of flumioxazin,
formulated as two 51% water-dispersible granular (WDG) formulations, on
alfalfa, asparagus, dry beans, assorted bushberries, fruiting vegetables
(including okra), melons, and tree nuts. The proposed use on alfalfa is
for a broadcast application within 7 days after cutting at 0.125 lb
ai/A. A total of two applications are proposed per season, and a 25-day
preharvest interval (PHI) is specified. For asparagus, the proposed use
is for a single broadcast application prior to spear emergence at up to
0.375 lb ai/A, with a 14-day PHI. For fruiting vegetables and okra, the
proposed use is for up to two soil applications, directed to row middles
at up to 0.125 lb ai/A, following transplanting or seedling emergence
and again \~21 days prior to harvest, for a maximum of 0.25 lb
ai/A/season. A 21-day PHI is specified for fruiting vegetables, and
applications may include use of a crop oil concentrate (COC) at 1% v/v.
For melons, the proposed use is for up to two soil applications directed
to row middles at up to 0.125 lb ai/A; the applications are made either
preplant or preemergence and again 21-28 days later, for a maximum of
0.25 lb ai/A/season. No PHI is specified for melons. For dry beans, the
proposed use is for a single broadcast application at up to 0.093 lb
ai/A, as either a preemergence application (weed control), or as a
late-season broadcast foliar application (harvest aid). A 5-day PHI is
specified for dry beans, and the late-season use may include a COC at 1%
v/v. For tree nuts, the proposed use is for up to two soil-directed
applications at 0.375 lb ai/A at retreatment intervals (RTIs) of 60
days, for a maximum use rate of 0.75 lb ai/A/season with a PHI of 60
days. For bushberries, the proposed use is for up to two soil-directed
applications at 0.375 lb ai/A, during early spring and again during the
later stages of berry development, for a maximum use rate of 0.75 lb
ai/A/season. A 7-day PHI is specified, and only the single early season
application is allowed on lowbush blueberries. In addition to these new
uses, IR-4 is also requesting that the current use directions for garlic
be amended to increase the maximum use rate to 0.38 lb ai/A for the
preemergence application. In conjunction with the above uses, the
petitioners are proposing the following permanent tolerances for
flumioxazin:

> Alfalfa, forage 1.0 ppm
>
> Alfalfa, hay 2.0 ppm
>
> Asparagus 0.02 ppm
>
> Fruiting Vegetables, Group 8 0.02 ppm
>
> Okra 0.02 ppm
>
> Melon, subgroup 9A 0.02 ppm
>
> Bean, dry, seed 0.06 ppm
>
> Tree Nuts, Group 14 0.02 ppm
>
> Bushberry, subgroup 13B 0.02 ppm
>
> Aronia berry 0.02 ppm
>
> Blueberry, lowbush 0.02 ppm
>
> Blueberry, highbush 0.02 ppm
>
> Buffalo currant 0.02 ppm
>
> Chilean guava 0.02 ppm
>
> Currant, black 0.02 ppm
>
> Currant, red 0.02 ppm
>
> Elderberry 0.02 ppm
>
> European barberry 0.02 ppm
>
> Gooseberry 0.02 ppm
>
> Highbush cranberry 0.02 ppm
>
> Honeysuckle 0.02 ppm
>
> Jostaberry 0.02 ppm
>
> Juneberry, including Saskatoon berry 0.02 ppm
>
> Lingonberry 0.02 ppm
>
> Native currant 0.02 ppm
>
> Salal 0.02 ppm
>
> Sea buckthorn 0.02 ppm

Based on adequate corn, sugarcane, grape, hen and goat metabolism data,
the nature of flumioxazin residues in plants and animals is understood.
In primary and rotated crops, the residue of concern is only the parent
compound. For ruminants, the residues of concern are parent,
3-OH-flumioxazin, 4-OH-flumioxazin, plus Metabolites B, C, and F. For
poultry, the residues of concern are parent, 3-OH-flumioxazin,
4-OH-flumioxazin, and 4-OH-S-53482-SA.

[]{.mark}

An adequate gas chromatography/nitrogen-phosphorus detection (GC/NPD)
method is available for enforcing tolerances of flumioxazin in/on plant
commodities (Valent Method RM-30-A-1). The reported method limits of
quantitation and detection (LOQ and LOD) for flumioxazin in plant
commodities are 0.02 and 0.01 ppm, respectively. Residues of flumioxazin
in samples of raw agricultural commodities (RACs) from the current field
trials were determined using an adequate GC/NPD method (Method
RM-30A-3), which is a more recent version of the enforcement method. The
validated method LOQ for flumioxazin in/on all plant commodities is 0.02
ppm, and the LODs range from 0.005 to 0.01 ppm.

Adequate liquid chromatography with tandem mass spectroscopy detection
(LC/MS/MS) methods are also available for collecting data on residues of
flumioxazin, 3-OH-flumioxazin and 4-OH-flumioxazin in milk (Method
RM-30MK) and cattle tissues (Method RM-30T). The validated method LOQ is
0.02 ppm for each analyte in milk and tissues, and the reported LOD is
0.01 ppm.

New storage stability data were provided in conjunction with the field
trials. These studies indicate that flumioxazin is stable in frozen
storage (≤-15°C) for intervals of up to 30 months in alfalfa forage and
hay, 22 months in dry beans, 7 months in tomatoes and asparagus, 5.8
months in blueberries, and up to 4.4 months in cantaloupes and pecans.
Some apparent decline (19%) was observed in frozen peppers after 26
months of storage; however, this level of decline could not be verified
as only one storage interval was tested. In addition, any correction of
residue levels in peppers would not alter the recommended tolerance in
fruiting vegetables. Together with earlier storage stability data on a
wide variety of plant commodities, the new storage stability data
support the sample storage durations and conditions used in the
submitted field trials.

The new field trials on cantaloupes, tomatoes, peppers, dry beans,
asparagus, blueberries, and pecans are adequate, and together with the
previously submitted almond data, these field trials support the
proposed uses. An adequate number of tests were conducted on each crop
in the appropriate regions, and samples were analyzed for the residue of
concern using an adequate method.

In the eight cantaloupe field trials conducted during 2003, flumioxazin
(WDG) was applied as two soil applications directed to row middles at
0.121-0.130 lb ai/A/application, for a total use rate of 0.245-0.256 lb
ai/A (1x rate). The initial application was made either preplant or
preemergence, and the second application was made during later
vegetative development or at blooming, at RTIs of 30-47 days.
Flumioxazin residues were \<LOD (\<0.008 ppm) in/on all samples of
cantaloupes harvested at maturity, following a PHI of 36-69 days.

In the 12 tomato and 9 pepper field trials conducted during 2003,
flumioxazin (WDG) was applied as two soil applications directed to row
middles at 0.120-0.134 lb ai/A/application, for a total use rate of
0.244-0.259 lb ai/A (1x rate). The initial application was made to
seedlings or transplants during early vegetative development, and the
second application was made approximately 21 days prior to crop
maturity, for RTIs of 42-103 days. All applications included the use of
a COC as an adjuvant at 1% v/v. At crop maturity (15-21 day PHI),
flumioxazin residues were \<LOD (\<0.007 ppm) in/on all pepper samples
and \<LOQ (\<0.02 ppm) in/on all tomato samples.

In the 12 dry bean field trials conducted during 2003, flumioxazin (WDG)
was applied as a single pre-harvest, broadcast application at
0.091-0.096 lb ai/A (1x rate), and all applications included the use of
a COC at 0.6-2.5%. At normal crop maturity (4-6 day PHI), flumioxazin
residues were \<0.02-0.05 ppm in/on 26 samples of dried beans, with 22
samples having residues \<LOQ (\<0.02 ppm).

In the eight asparagus field trials conducted during 2003/2004,
flumioxazin (WDG) was applied as a single broadcast application to
dormant or recently cut asparagus at approximately 2 weeks prior to
harvest. Each test site included two plots treated at either 0.190-0.197
lb ai/A or 0.380-0.404 lb ai/A (0.5x and 1x rates). For both application
rates, flumioxazin residues were \<LOQ in/on all samples harvested at an
8-20 day PHI.

In the lowbush (1 trial) and highbush (5 trials) blueberry field trials
conducted during 2003, flumioxazin (WDG) was applied as either as single
broadcast application to dormant lowbush blueberries at 0.40 lb ai/A (1x
rate), or as two soil-directed applications to highbush blueberries at
0.370-0.405 lb ai/A/application, for a total use rate of 0.744-0.797 lb
ai/A (1x rate). The first application to highbush blueberries was made
around bud break/flowering and the second application was made 50-113
days later during fruit development. At normal crop maturity,
flumioxazin residues were \<LOD (\<0.006 ppm) in/on two samples of
lowbush blueberries (99 DAT) and \<LOQ (\<0.02 ppm) in/on 10 samples of
highbush blueberries collected at a PHI of 6-8 days.

In the four almond field trials conducted during 1999 and the five pecan
field trials conducted during 2003, flumioxazin (WDG) was applied to
trees as two soil-directed applications during nut development at rates
of 0.375 lb ai/A/application and RTIs of 58-61 days, for a total use
rate of 0.75-0.76 lb ai/A/season (1x rate). At normal nut maturity
(42-61 DAT), flumioxazin residues were \<LOQ in/on eight samples of
almonds (\<0.01 ppm) and 10 samples of pecans (\<0.02 ppm). Residues
in/on eight samples of almond hulls from the 1x application were
\<0.01-0.066 ppm.

The 12 alfalfa field trials conducted from 2003-2005 are also adequate
to support the proposed use of two applications per season. However, the
recommended tolerance will be based on the highest subset or combination
of residue data. In six trials, flumioxazin (WDG) was applied to alfalfa
as a single broadcast application within 7-9 days after the 1^st^
cutting at 0.12-0.13 lb ai/A, and in the other six trials, flumioxazin
(WDG) was applied as two broadcast applications at 0.12-0.13 lb ai/A, to
dormant alfalfa and again following the 1^st^ cutting, for a total use
rate of 0.24-0.26 lb ai/A. Applications included the use of a non-ionic
surfactant (NIS) as an adjuvant at 0.25% v/v. Although half of the
trials included an extra application to dormant alfalfa at the start of
the season, residues in/on forage and hay from the 2nd, 3rd and 4th
cutting were similar across all 12 trials. Flumioxazin residues in/on
forage and hay were respectively \<0.02-1.70 ppm and 0.06-5.50 ppm from
the 2^nd^ cutting (24-26 day PHI), \<0.02-0.19 ppm and \<0.02-0.09 ppm
from the 3^rd^ cutting (45-70 day PHI), and \<0.02-0.06 ppm and
\<0.02-0.15 ppm from the 4^th^ cutting (71-128 day PHI). Residue decline
data from one field trial also indicated that residues in/on both forage
and hay decline at longer post-treatment intervals.

In addition, the previously reviewed bulb onion field trial data will
support the requested increase in the use rate for garlic to 0.38 lb
ai/A. Following two postemergence, broadcast applications of flumioxazin
(WDG) to onions in nine tests at rates totaling 0.185-0.200 lb ai/A,
flumioxazin residues were \<LOQ (\<0.02 ppm) in/on all samples of bulb
onions harvested at a 42-49 day PHI. Although the bulb onion data were
conducted at only \~0.5x the proposed maximum use rate for garlic, the
postemergence applications to onions occurred at a much later growth
stage than allowed for garlic (preemergence), and the typical harvest
interval for garlic would be \>200 days, compared to the 45-day PHI for
bulb onions.

[]{.mark}

No processing studies were submitted with the current petitions.
Although a tomato processing study is typically required to support uses
on fruiting vegetables, the available tomato field trial data indicated
that flumioxazin residues in/on tomatoes were \<LOQ following
applications at 5x the maximum proposed use rate. Therefore, a tomato
processing study is not required, and separate tolerances are not
required for processed tomato commodities.

Based on the established and recommended tolerances for flumioxazin
residues in feedstuffs, and recent Agency guidance on calculating
reasonably balanced livestock diets, the theoretical dietary burden
(TDB) of flumioxazin residues to livestock was calculated to be 0.96 ppm
for beef cattle, 3.19 ppm for dairy cattle, 0.005 ppm for poultry and
0.004 ppm for swine.

An adequate cattle feeding study is available in which lactating dairy
cows (3/group) were dosed orally with flumioxazin at levels equivalent
to 2, 6 and 20 ppm in their diet for 28 consecutive days (0.6, 1.9 and
6.3x the TDB). Composited samples of milk were collected throughout the
study, and subsamples of milk from Day 24 were used to generate cream
and skim milk samples. Samples of liver, kidney, composited muscle, and
composited fat were also collected from each animal within 24 hours of
the final dose. Milk and tissue samples were analyzed using the adequate
data collection methods discussed above, and no supporting storage
stability data were required as all frozen samples were analyzed within
30 days of collection. For the 20 ppm dose group, residues of
flumioxazin, 3-OH-flumioxazin and 4-OH-flumioxazin were each
non-detectable (\<0.01 ppm) in all samples of milk, skim milk, cream,
and tissues from all three cows.

As residues of flumioxazin and its two hydroxy metabolites were \<LOD in
milk and tissues from cattle dosed at 6.3x TDB, quantifiable residues
are unlikely to occur in cattle commodities. Therefore, tolerances for
flumioxazin residues are not required for commodities from cattle,
goats, hogs, horses or sheep (40 CFR §180.6\[a\]\[3\]). In addition,
results from the available poultry metabolism study, in which hens were
dosed for 14 days at levels equivalent to \>1,800x TDB, indicate that
quantifiable residues are unlikely to occur in eggs or poultry tissues.
Therefore, tolerances for flumioxazin residues are also not required in
eggs or poultry tissues.

An adequate confined rotational crop study is available to support the
uses on the proposed crops that can be rotated (alfalfa, dry beans,
fruiting vegetables, melon and garlic). Based on the results of the
confined accumulation study, ARIA concludes that the current rotational
crop plant-back intervals (PBIs) are acceptable, and that field trials
for, and tolerances in, rotated crops are not necessary.

Number range CHAPTER**Regulatory Recommendations and Residue Chemistry
Deficiencies**

No major deficiencies were noted in the subject petitions that would
preclude establishing permanent tolerances for flumioxazin on the
proposed commodities; however, the petitioner should address the
deficiencies noted below. The available rNumber range CHAPTEResidue data
support Number range CHAPTERestablishing permanent tolerances for
flumioxazin residues at 0.02 ppm in/on asparagus, fruiting vegetables,
melons, okra, tree nuts and assorted bushberries, at 0.05 ppm in/on dry
beans, and at 3.0 and 8.0 ppm respectively in/on alfalfa forage and hay.
Number range CHAPTERA summary of the proposed and recommended
tolerances, along with the correct commodity definitions for the
requested commodities, are presented in Table 7.

> • Use directions for the proposed crops should be revised as indicated
> under the conclusions for the Use Directions Section.
>
> []{.mark}
>
> • Section F of both petitions should be revised to reflect the
> recommended tolerance levels and correct commodity definitions listed
> in Table 7.

**Background**

Flumioxazin is an herbicide of the N-phenylphthalimide class that is
currently used for pre- and post-emergence control of susceptible weeds
in a variety of fruit, vegetable and other field crops. Its mode of
action is as an inhibitor of protoporphyrinogen oxidase (PPO); it is
active against certain grasses, broadleaf weeds, and sedges. Tolerances
are currently established for residues of flumioxazin in/on various
plant commodities, at levels ranging from 0.02 to 0.70 ppm (40 CFR
§180.568\[a\]). Tolerances associated with a Section 18 emergency
exemption have also been established on alfalfa forage and hay at 0.13
and 0.45 ppm, respectively (40 CFR 180.568\[b\]) (Expiration date
31/DEC/2009).

Valent has submitted a petition (PP# 6F7092) proposing the use of
flumioxazin formulated as a 51% WDG on alfalfa, and IR-4 has submitted a
separate petition (PP# 6E7151) proposing new uses of flumioxazin on tree
nuts, melons, dry beans, bushberries, fruiting vegetables (including
okra), and asparagus. The nomenclature and physicochemical properties of
flumioxazin are presented below in Tables 1 and 2.

  ------------------------------------------------------------------------------------------------------------------------------------------------
  **Table 1.          
  Flumioxazin         
  Nomenclature.**     
  ------------------- ----------------------------------------------------------------------------------------------------------------------------
  Compound            ![](media/image2.wmf){width="2.209722222222222in" height="1.4979166666666666in"}

  Common name         Flumioxazin

  Company             VC-1152
  experimental name   

  IUPAC name          *N*-(7-fluoro-3,4-dihydro-3-oxo-4-prop-2-ynyl-2*H*-1,4-benzoxazin-6-yl)cyclohex-1-ene-1,2-dicarboxamide

  CAS name            2-\[7-fluoro-3,4-dihydro-3-oxo-4-(2-propynyl)-2*H*-1,4-benzoxazin-6-yl\]-4,5,6,7-tetrahydro-1*H*-isoindole-1,3(2*H*)-dione

  CAS registry number 103361-09-7

  End-use product     51% WDG, Valor Herbicide and Chateau ™ WDG Herbicide
  (EP)                
  ------------------------------------------------------------------------------------------------------------------------------------------------

+--------------------------+-------------------------+-----------------+
| **Table 2.               |                         |                 |
| Physicochemical          |                         |                 |
| Properties of            |                         |                 |
| Flumioxazin.**           |                         |                 |
+==========================+=========================+=================+
| Parameter                | Value                   | Reference       |
+--------------------------+-------------------------+-----------------+
| Melting point/range      | 202-204 °C              | EPA Pesticide   |
|                          |                         | Fact Sheet for  |
|                          |                         | flumioxazin     |
|                          |                         | issued on April |
|                          |                         | 12, 2001 for    |
|                          |                         | conditional     |
|                          |                         | registration    |
|                          |                         | (http://www     |
|                          |                         | .epa.gov/opprd0 |
|                          |                         | 01/factsheets/f |
|                          |                         | lumioxazin.pdf) |
+--------------------------+-------------------------+-----------------+
| pH                       | 7.29 at 25 °C           |                 |
+--------------------------+-------------------------+-----------------+
| Density                  | 1.51 g/ml at 20 °C      |                 |
+--------------------------+-------------------------+-----------------+
| Water solubility (25°C)  | 1079 mg/L               |                 |
+--------------------------+-------------------------+-----------------+
| Solvent solubility       | Not available           |                 |
+--------------------------+-------------------------+-----------------+
| Vapor pressure           | 2.41 x10^-6^ mm Hg      |                 |
+--------------------------+-------------------------+-----------------+
| Dissociation constant,   | None                    |                 |
| pK~a~                    |                         |                 |
+--------------------------+-------------------------+-----------------+
| Octanol/water partition  | 2.55 at 20 °C           |                 |
| coefficient, Log(K~OW~)  |                         |                 |
+--------------------------+-------------------------+-----------------+
| UV/visible absorption    | ~218~,  = 14700 (pH   |                 |
| spectrum                 | 1.9)                    |                 |
|                          |                         |                 |
|                          | ~216~,  = 43600 (pH   |                 |
|                          | 6.8)                    |                 |
|                          |                         |                 |
|                          | ~216~,  = 51200 (pH   |                 |
|                          | 10.0)                   |                 |
+--------------------------+-------------------------+-----------------+

**Directions for Use**

Valent and IR-4 are proposing Number range CHAPTERnew uses of
flumioxazin for weed control in alfalfa, dry beans, fruiting vegetables
(including okra), melons, bushberries, and asparagus and for use as a
harvest aid on dry beans. IR-4 has also proposed expanding the existing
use on almonds to include all tree nuts and amending the existing use on
garlic to increase the use rate. The formulations being proposed for
these uses include two 51% WDG formulations (VALOR^®^ Herbicide, EPA
Reg. No. 59639-99; CHATEAU^®^ WDG Herbicide, EPA Reg. No. 59639-119).
These formulations are currently registered to Valent for use on a wide
variety of fruit, vegetable and other field crops at maximum seasonal
use rates of 0.05-0.75 lb ai/A.

Valent provided example labels containing the proposed use directions
for alfalfa, and IR-4 provided example labels containing the use
directions for the other crops. IR-4 also provided summaries of the
proposed use directions in Section B of their petition. With the
exception of alfalfa, the use directions summarized in Table 3 were
obtained from the summaries provided by IR-4.

+-----------------+-------+----+------+-------+---+-----------------+
| **Table 3.      |       |    |      |       |   |                 |
| Summary of      |       |    |      |       |   |                 |
| Directions for  |       |    |      |       |   |                 |
| Use of          |       |    |      |       |   |                 |
| Flumioxazin.    |       |    |      |       |   |                 |
| ^1^**           |       |    |      |       |   |                 |
+=================+=======+====+======+=======+===+=================+
| Applic. Timing, | F     | A  | Max. | Max.  | P | Use Directions  |
| Type, and       | ormul | pp | No.  | Sea   | H | and Limitations |
| Equip.          | ation | li | App  | sonal | I | ^2^             |
|                 |       | c. | lic. | Ap    |   |                 |
|                 | \[EPA | Ra | per  | plic. | ( |                 |
|                 | Reg.  | te | Se   | Rate  | d |                 |
|                 | No.\] |    | ason |       | a |                 |
|                 |       | (  |      | (lb   | y |                 |
|                 |       | lb |      | ai/A) | s |                 |
|                 |       | a  |      |       | ) |                 |
|                 |       | i/ |      |       |   |                 |
|                 |       | A) |      |       |   |                 |
+-----------------+-------+----+------+-------+---+-----------------+
| **Alfalfa       |       |    |      |       |   |                 |
| (established    |       |    |      |       |   |                 |
| plantings)**    |       |    |      |       |   |                 |
+-----------------+-------+----+------+-------+---+-----------------+
| Broadcast       | 51%   | 0  | 2    | 0.25  | 2 | A minimum RTI   |
| foliar          | WDG   | .1 |      |       | 5 | of 60 days is   |
| application     | \[    | 25 |      |       |   | specified.      |
| within 7 days   | 59639 |    |      |       |   |                 |
| after cutting;  | -99\] |    |      |       |   | Do not apply    |
| ground or       |       |    |      |       |   | with any        |
| aerial          | \[5   |    |      |       |   | adjuvants or    |
| equipment       | 9639- |    |      |       |   | tank mix with   |
|                 | 119\] |    |      |       |   | EC              |
|                 |       |    |      |       |   | formulations.   |
|                 |       |    |      |       |   |                 |
|                 |       |    |      |       |   | Do not use on   |
|                 |       |    |      |       |   | mixed stands of |
|                 |       |    |      |       |   | alfalfa and     |
|                 |       |    |      |       |   | grass.          |
+-----------------+-------+----+------+-------+---+-----------------+
| **Dry Beans**   |       |    |      |       |   |                 |
+-----------------+-------+----+------+-------+---+-----------------+
| **Weed          | 51%   | 0  | 1    | 0.093 | N | Apply in a      |
| control**:      | WDG   | .0 |      |       | A | minimum of 10   |
| Preemergence    | \[    | 93 |      | (     |   | gal/A.          |
| broadcast       | 59639 |    |      | 0.05) |   |                 |
| application;    | -99\] | (0 |      |       |   | Use is          |
| ground          |       | .0 |      |       |   | restricted to   |
| equipment       | \[5   | 5) |      |       |   | areas west of   |
|                 | 9639- |    |      |       |   | US Hwy 83 in CO |
|                 | 119\] |    |      |       |   | and NE          |
+-----------------+-------+----+------+-------+---+-----------------+
| **Harvest       |       | 0  | 1    | 0.093 | 5 | Application may |
| aid:**          |       | .0 |      |       |   | include a COC   |
| Broadcast       |       | 93 |      | (     |   | at 1% v/v.      |
| foliar          |       |    |      | 0.05) |   |                 |
| application to  |       | (0 |      |       |   | Apply in a      |
| mature beans;   |       | .0 |      |       |   | minimum of 10   |
| ground          |       | 5) |      |       |   | gal/A (15       |
| equipment       |       |    |      |       |   | gal/A).         |
+-----------------+-------+----+------+-------+---+-----------------+
| **Fruiting      |       |    |      |       |   |                 |
| Vegetables      |       |    |      |       |   |                 |
| (including      |       |    |      |       |   |                 |
| okra)**         |       |    |      |       |   |                 |
+-----------------+-------+----+------+-------+---+-----------------+
| Directed soil   | 51%   | 0  | 2    | 0.25  | 2 | Applications    |
| applications to | WDG   | .1 |      |       | 1 | may include a   |
| row middles     | \[    | 25 | \    | (0    |   | COC at 1% v/v.  |
| after           | 59639 |    | (1\) | .096) | ( |                 |
| transplanting   | -99\] | (  |      |       | N | Apply in a      |
| or emergence    |       | 0. |      |       | S | minimum of 10   |
| and             | \[5   | 09 |      |       | ) | gal/A (15       |
| approximately   | 9639- | 6) |      |       |   | gal/A).         |
| 21 days prior   | 119\] |    |      |       |   |                 |
| to harvest;     |       |    |      |       |   | Use directed    |
| ground          |       |    |      |       |   | for shielded    |
| equipment       |       |    |      |       |   | sprayers for    |
|                 |       |    |      |       |   | all             |
|                 |       |    |      |       |   | applications.   |
+-----------------+-------+----+------+-------+---+-----------------+
| **Melons**      |       |    |      |       |   |                 |
+-----------------+-------+----+------+-------+---+-----------------+
| Directed soil   | 51%   | 0  | 2    | 0.25  | N | Minimum RTIs of |
| applications to | WDG   | .1 |      |       | S | 21-28 days.     |
| row middles,    | \[    | 25 | \    | (0    |   |                 |
| preplant or     | 59639 |    | (1\) | .096) |   | Use directed    |
| preemergence,   | -99\] | (  |      |       |   | for shielded    |
| and             |       | 0. |      |       |   | sprayers for    |
| post-emergence  | \[5   | 09 |      |       |   | all             |
| 21-28 days      | 9639- | 6) |      |       |   | applications.   |
| later; ground   | 119\] |    |      |       |   |                 |
| equipment       |       |    |      |       |   | Apply in a      |
|                 |       |    |      |       |   | minimum of 10   |
|                 |       |    |      |       |   | gal/A (15       |
|                 |       |    |      |       |   | gal/A).         |
+-----------------+-------+----+------+-------+---+-----------------+
| **Bushberries** |       |    |      |       |   |                 |
+-----------------+-------+----+------+-------+---+-----------------+
| **Lowbush       | 51%   | 0  | 1    | 0.375 | N | Apply in a      |
| blueberry:**    | WDG   | .3 |      |       | S | minimum of 20   |
| Directed soil   | \[    | 75 |      |       |   | gal/A (15       |
| application in  | 59639 |    |      |       |   | gal/A).         |
| early spring;   | -99\] |    |      |       |   |                 |
| ground          |       |    |      |       |   | The minimum RTI |
| equipment       | \[5   |    |      |       |   | is 30 days.     |
|                 | 9639- |    |      |       |   |                 |
|                 | 119\] |    |      |       |   |                 |
+-----------------+-------+----+------+-------+---+-----------------+
| **Other         |       | 0  | 2    | 0.75  | 7 |                 |
| bushberries:**  |       | .3 |      |       |   |                 |
| Directed soil   |       | 75 |      |       |   |                 |
| application in  |       |    |      |       |   |                 |
| early spring    |       |    |      |       |   |                 |
| and during the  |       |    |      |       |   |                 |
| later stages of |       |    |      |       |   |                 |
| berry           |       |    |      |       |   |                 |
| development.    |       |    |      |       |   |                 |
+-----------------+-------+----+------+-------+---+-----------------+
| **Tree Nuts     |       |    |      |       |   |                 |
| (including      |       |    |      |       |   |                 |
| pistachios)**   |       |    |      |       |   |                 |
+-----------------+-------+----+------+-------+---+-----------------+
| Soil directed   | 51%   | 0  | 2    | 0.75  | 6 | The minimum RTI |
| applications;   | WDG   | .3 |      |       | 0 | is 60 days (30  |
| ground          | \[    | 75 |      |       |   | days). Apply in |
| equipment       | 59639 |    |      |       |   | a minimum of 20 |
|                 | -99\] |    |      |       |   | gal/A (15       |
|                 |       |    |      |       |   | gal/A).         |
|                 | \[5   |    |      |       |   |                 |
|                 | 9639- |    |      |       |   |                 |
|                 | 119\] |    |      |       |   |                 |
+-----------------+-------+----+------+-------+---+-----------------+
| **Asparagus**   |       |    |      |       |   |                 |
+-----------------+-------+----+------+-------+---+-----------------+
| Broadcast soil  | 51%   | 0  | 1    | 0.375 | 1 | Apply in a      |
| application     | WDG   | .3 |      |       | 4 | minimum of 20   |
| prior to spear  | \[    | 75 |      | (0    |   | gal/A (or 15    |
| emergence       | 59639 |    |      | .255) |   | gal/A).         |
|                 | -99\] | (  |      |       |   |                 |
|                 |       | 0. |      |       |   |                 |
|                 | \[5   | 25 |      |       |   |                 |
|                 | 9639- | 5) |      |       |   |                 |
|                 | 119\] |    |      |       |   |                 |
+-----------------+-------+----+------+-------+---+-----------------+
| **Garlic**      |       |    |      |       |   |                 |
+-----------------+-------+----+------+-------+---+-----------------+
| Preemergence    | 51%   | 0. | 1    | 0.38  | N | Apply in a      |
| broadcast       | WDG   | 38 |      |       | S | minimum of 10   |
| application     | \[    |    |      |       |   | gal/A.          |
| within 3 days   | 59639 |    |      |       |   |                 |
| of planting;    | -99\] |    |      |       |   |                 |
| ground          |       |    |      |       |   |                 |
| equipment       | \[5   |    |      |       |   |                 |
|                 | 9639- |    |      |       |   |                 |
|                 | 119\] |    |      |       |   |                 |
+-----------------+-------+----+------+-------+---+-----------------+

^1^ Where there is a difference in information between the summarized
use directions and the example labels, the information from the example
labels is indicated by shading.

^2^ Rotational crop restriction: Do not plant any crop except cotton,
peanut, soybean and sugarcane earlier than 30 days after application of
flumioxazin.

NS = not specified.

***Conclusions:*** The available labels and summaries of the proposed
use directions are adequate for evaluation of the field trial data.
However, discrepancies were noted in the maximum use rates and the
minimum application volumes listed on example labels when compared to
those in the use summaries provided by IR-4. For purposes of this
review, the use summaries provided by IR-4 were considered to represent
the intended 1x use rate. For each crop, the use directions on the
proposed labels must be reconciled with the directions listed in the use
summaries, and new labels should be submitted. Based on the available
field trial data, the following revisions should also be made to the
proposed labels for the 51% WDG formulations.

> • For dry beans, the labels may specify a maximum single and seasonal
> use rate of up to 0.093 lb ai/A, including both the preemergence and
> pre-harvest uses.
>
> • For fruiting vegetables (including okra) and melons, labels may
> allow for up to two directed applications per season at up to 0.125 lb
> ai/A/application.
>
> • For melons, applications after blooming should be prohibited.
>
> • For tree nuts, the labels should specify a minimum RTI of 60 days
> rather than 30 days.
>
> • For asparagus, a maximum single application rate of up to 0.375 lb
> ai/A may be specified.

**860/1300 Nature of the Residue -- Plants**

MARC Decision Memo, DP Num: 272652, R. Loranger, 12/MAR/2001

Number range CHAPTERAdequate plant metabolism studies are available
depicting the uptake and metabolism of \[^14^C\]-flumioxazin following
pre-emergence or soil-directed applications to soybeans, peanuts, corn,
sugarcane, and grapes (DP Num: 259493, D. Dotson; 12/MAR/2001; and
45375504.der, 45888501.der, and 45375503.der, M. Doherty). Based on
these studies, the HED has determined that the parent compound only is
the residue of concern to be used in risk assessments and the tolerance
expression for primary and rotated crops. The crops and use patterns
utilized in the available metabolism studies adequately cover the
proposed uses.

**860.1300 Nature of the Residue -- Livestock**

MARC Decision Memo; DP Num: 272652; R. Loranger; 12/MAR/2001

Adequate ruminant and poultry metabolism studies are available depicting
the metabolism of flumioxazin radiolabeled in either the phenyl or
tetrahydrophthaloyl (THP) ring (DP Num: 194594, J. Garbus, 22/SEP/1994;
and DP Num: 259493, D. Dotson, 12/MAR/2001). In the ruminant studies,
dairy goats were dosed orally for 5 days with phenyl-\[^14^C\]-
flumioxazin or THP-\[^14^C\]-flumioxazin at levels equivalent to 7.2 and
11.8 ppm in the diet, which represent approximately 4.7x and 7.8x the
TDB. Levels of total radioactive residues (TRR) in tissues were similar
for the two \[^14^C\]-labels, at 0.012 to 0.028 ppm in muscle, 0.004 to
0.010 ppm in fat, 0.110 to 0.330 ppm in liver and kidney, and 0.005 to
0.055 ppm in milk.

In the poultry studies, laying hens were dosed orally for 14 days with
phenyl-\[^14^C\]- flumioxazin or THP-\[^14^C\]-flumioxazin at levels
equivalent to 9.0 and 9.9 ppm in the diet, which represent approximately
2250x and 2475x the TDB. For the phenyl-\[^14^C\]-label, TRR were 0.040
to 0.074 ppm in muscle and fat, 0.237 ppm in liver, 0.437 ppm in egg
yolks, and 0.018 ppm in egg whites. For the THP-\[^14^C\]-label, TRR
were 0.138 to 0.226 ppm in muscle and fat, 1.137 ppm in liver, 0.531 to
0.760 ppm in egg yolks (Days 9 to 14), and 0.024 to 0.041 ppm in egg
whites.

The metabolism of flumioxazin is similar in both ruminants and poultry,
involving the hydroxylation and reduction of the cyclohexene ring in the
THP moiety, hydrolytic cleavage of the imide and amide linkages, and
incorporation of sulfonic acid into the THP moiety. After reviewing the
available studies, the MARC determined that the residues of concern for
ruminants should include parent, 3-OH-flumioxazin, 4-OH-flumioxazin, and
Metabolites B, C, and F. For poultry, the residues of concern are
parent, 3-OH-flumioxazin, 4-OH-flumioxazin, and 4-OH-S-53482-SA.

**860.1340 Residue Analytical Methods**

[]{.mark}

**Plant Commodities** An adequate GC/NPD method is available for
enforcing tolerances of flumioxazin in plant commodities (MRID No.
43935509, Valent Residue Method #RM-30A-1, *Determination of Flumioxazin
Residues in Crops,* J. Garbus, 08/JAN/1996). This method has undergone a
successful independent laboratory validation (ILV) trial and a
successful petition method validation (PMV) trial by the Agency. The
reported method LOQ and LOD for flumioxazin are 0.020 and 0.010 ppm,
respectively. However, the validated LOQ was 0.010 ppm for residues in
soybean seed, forage, and hay in the PMV trial, and the LOD was 0.005
ppm.

[]{.mark}

In the crop field trials submitted in support of the current petitions,
residues of flumioxazin were determined in plant commodities using a
GC/NPD method (Valent Method RM-30A-3), which is a more recent version
of the tolerance enforcement method. For Method RM-30A-3, residues are
extracted with acetone/water (4:1, v/v) and then partitioned into DCM.
After evaporation of the DCM, residues are purified by partitioning
between hexane/ACN. The residues in the ACN phase are then concentrated,
re-dissolved in hexane/ethyl acetate, and purified using a Florisil
column eluted with hexane/ethyl acetate (2:1 v/v). Residues in the
eluate were concentrated, reconstituted in acetone, and then analyzed by
GC/NPD, using external standards.

Method RM-30A-3 was adequately validated in conjunction with the
analysis for samples from each of the field trials. The validated method
LOQ for flumioxazin in/on all plant commodities is 0.02 ppm, and the
LODs range from 0.005 ppm (asparagus) to 0.01 ppm (pecans and alfalfa).

**Livestock Commodities** As tolerances for livestock commodities are
not required, an enforcement method for livestock commodities is not
necessary. However, adequate data collection methods were submitted in
conjunction with the cattle feeding study (46889603.der, D. Rate,
10/SEP/2007). Residues of flumioxazin and its two hydroxy metabolites
(3-OH-flumioxazin and 4-OH-flumioxazin) were determined in milk and
tissues using two related LC/MS/MS methods, Valent Methods RM-30MK for
milk and RM-30T for tissues.

For Method RM-30MK, milk samples are diluted with acetone and
centrifuged. The resulting supernatant is diluted with 5% sodium
chloride solution, and residues are partitioned into DCM. Residues are
then concentrated to dryness, and re-dissolved and partitioned in
hexane/ACN. Residues in the resulting ACN phase are concentrated to
dryness, and re-dissolved in methanol/water (1:1, v/v). Residues are
determined by LC/MS/MS using a high performance liquid chromatography
(HPLC) system consisting of a C~8~ column with a mobile phase gradient
of water to methanol, each containing 0.05% formic acid. Residues were
quantified by MS/MS using external standards and the m/z 355→299
transition for parent, m/z 371→299/107 transitions for 3-OH-flumioxazin,
and the m/z 371→299/107 transitions for 4-OH-flumioxazin.

For Method RM-30T, residues in tissue samples are extracted sequentially
with ACN and ACN/water (1:1, v/v) containing 1% acetic acid. The
extracts are combined and concentrated to remove the ACN, and diluted
with 5% sodium chloride solution. Residues are then partitioned into
DCM, concentrated to dryness, and re-dissolved and partitioned in
hexane/ACN. Residues in the resulting ACN phase are concentrated to
dryness, and re-dissolved in methanol/water (1:1, v/v). Residues are
determined by LC/MS/MS using an HPLC system consisting of a C~8~ column
with a mobile phase gradient of water to methanol, each containing 0.05%
formic acid. Residues were quantified by MS/MS using external standards
and the m/z 355→299 transition for parent, m/z 371→299/107 transitions
for 3-OH-flumioxazin, and the m/z 371→299/107 transitions for
4-OH-flumioxazin.

The above methods were adequately validated in conjunction with the
analysis of the feeding study samples using control samples of milk and
tissues fortified with each analyte at 0.02 and 0.10 ppm. Recoveries
from milk, cream and skim milk averaged 84-92% (± 1-9%) for flumioxazin,
89-95% (± 8-11%) for 3-OH-flumioxazin, and 84-93% (± 6-10%) for
4-OH-flumioxazin. Recoveries from tissues averaged 77-88% (± 3-12%) for
flumioxazin, 85-102% (± 12-25%) for 3-OH-flumioxazin, and 96-102% (±
17-20%) for 4-OH-flumioxazin. For both methods, the validated LOQ is
0.02 ppm for each analyte, and the reported LOD is 0.01 ppm.

**860.1360 Multiresidue Methods**

DP Num: 259493, D. Dotson, 12/MAR/2001

Number range CHAPTERData depicting the analysis of flumioxazin through
FDA Multiresidue Protocols were submitted and will be forwarded to FDA
for review. The multiresidue method testing data indicate that
flumioxazin is not recovered through Sections 304 and 402 of PAM, Vol.
I.

**860.1380 Storage Stability**

Storage stability data for flumioxazin residues in various plant
commodities are available from several earlier petitions (DP Num:
259493, D. Dotson, 12/MAR/2001; DP Num: 298647, W. Drew, 17/FEB/2004; DP
Num: 301247, W. Drew; 23/JUL/2004; and DP Num: 310408, W. Drew;
15/MAR/2006). Data from these petitions indicate that flumioxazin is
stable in frozen (-20ºC) storage for at least the following intervals:
13 months in sugarcane; 12 months in cherries and soybean forage, hay,
and seed; 10 months in peanut forage, hay, hulls, and nutmeats; 9 to 11
months in mint tops and oil; 9 months in prunes, wet apple pomace,
potatoes, and potato processed fractions; 6 months in apple juice,
grapes, raisins, and almond nutmeats and hulls; 4 months in dry bulb
onions; 3 months in cotton seed, gin byproducts, hulls, and meal; and 2
to 3 months in grape juice, and sugarcane molasses and refined sugar.

In conjunction with each of the new field trials, concurrent storage
stability studies were also conducted using control samples of each
commodity fortified with flumioxazin at 0.10 or 0.20 ppm and stored
under conditions similar to the field trial samples (≤-15ºC). These
studies indicated that flumioxazin is stable at -20ºC for at least the
following intervals: 30 months in alfalfa forage and hay; 22 months in
dry beans; 7 months in tomatoes and asparagus; 5.8 months in
blueberries; and 4 months in cantaloupes and pecans. The actual
durations of sample storage from the new crop field trials are presented
in Table 4.

Residue decline was observed only in the pepper storage stability study.
Following 786 days (25.8 months) of frozen storage, there was an
apparent 19% decline in flumioxazin residues in peppers. However, the
validity of the decline could not be confirmed as only one storage
interval was tested. In addition, the correction of residue levels in
peppers would have no impact on the conclusions regarding the tolerance
level in fruiting vegetables. Residues were non-detectable (\<0.007 ppm)
in/on all 18 pepper samples, and even if a 19% correction factor is
applied for decline during storage, the resulting residues on peppers
(0.009 ppm) would still be well below the method LOQ of 0.02 ppm.

[]{.mark}

[]{.mark}

+--------------+--------------+-----------------+----------------------+
| **Table 4.   |              |                 |                      |
| Summary of   |              |                 |                      |
| Storage      |              |                 |                      |
| Conditions   |              |                 |                      |
| and          |              |                 |                      |
| Intervals of |              |                 |                      |
| Samples from |              |                 |                      |
| Crop Field   |              |                 |                      |
| Trials.**    |              |                 |                      |
+==============+==============+=================+======================+
| Matrix       | Storage      | Actual Storage  | Interval of          |
|              | Temperature  | Duration        | Demonstrated         |
|              | (°C)         |                 |                      |
|              |              | (Days)          | Storage Stability    |
|              |              |                 | (Days)               |
+--------------+--------------+-----------------+----------------------+
| Alfalfa      | -20          | 455             | 929                  |
| forage and   |              |                 |                      |
| hay          |              |                 |                      |
+--------------+--------------+-----------------+----------------------+
| Pecan,       | -20 to -15   | 55-97           | 135                  |
| nutmeat      |              |                 |                      |
+--------------+--------------+-----------------+----------------------+
| Cantaloupes  | -25 to -15   | 58-125          | 125                  |
+--------------+--------------+-----------------+----------------------+
| Dry Bean,    | -25 to-15    | 309             | 684                  |
| seeds        |              |                 |                      |
+--------------+--------------+-----------------+----------------------+
| Blueberries  | -25 to-15    | 128-176         | 176                  |
+--------------+--------------+-----------------+----------------------+
| Asparagus    | -25 to -15   | 29-110          | 217                  |
+--------------+--------------+-----------------+----------------------+
| Tomato       | -25 to -15   | 204             | 212                  |
+--------------+--------------+-----------------+----------------------+
| Pepper       | -25 to -15   | 807             | 786 ^1^              |
+--------------+--------------+-----------------+----------------------+

^1^ An apparent 19% decline in residues was noted in peppers after 26
months of frozen storage.

***Conclusions*** The available storage stability data are adequate and
support the sample storage durations incurred in the alfalfa, pecan,
cantaloupe, dry bean, blueberry, asparagus, tomato and pepper field
trials. As frozen samples of whole milk, cream, skim milk and tissues
from the cattle feeding study were analyzed within 30 days of
collection, no storage stability data are required to support the
feeding study.

**860.1400 Water, Fish, and Irrigated Crops**

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

**860.1460 Food Handling**

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

**860.1480 Meat, Milk, Poultry, and Eggs**

46889603.der, D. Rate, 20/JUN/2007 (Cattle Feeding Study)

The potential dietary exposure of livestock to flumioxazin residues was
previously calculated to be 0.25 ppm for beef and dairy cattle, 0.008
ppm for poultry, and 0.15 ppm for swine under an earlier petition (DP
Num: 310408, W. Drew, 15/MAR/2006). However, the addition of uses on
alfalfa will increase the potential dietary burden of flumioxazin
residues for cattle. In addition, the Agency has recently revised its
guidance on calculating potential residues in livestock diets and
updated the types and percentages of feedstuffs listed in Table 1 of
OPPTS Guideline 860.1000 (Memo, ChemSAC, OCT/25/2006). Therefore, the
potential TDB of flumioxazin residues to livestock was recalculated
using the recent guidance on constructing a reasonably balanced diet for
livestock. The dietary exposure was calculated to be 0.96 ppm for beef
cattle, 3.19 ppm for dairy cattle, 0.005 ppm for poultry and 0.004 ppm
for swine (Table 5).

[]{.mark}

  --------------------------------------------------------------------------
  **Table 5.                                                
  Calculation of                                            
  Maximum Dietary                                           
  Burdens of                                                
  Flumioxazin                                               
  Residues to                                               
  Livestock.**                                              
  --------------- -------- -------- --------- ------------- ----------------
  Feedstuff       Type     \% Dry   \% Diet   Recommended   Dietary
                           Matter             Tolerance     Contribution
                                              (ppm)         (ppm)

  **Beef Cattle                                             
  R: 15%; CC: 75                                            
  %; PC: 10%**                                              

  Alfalfa, hay    R        89       10        8.0           0.90

  Cotton, gin     R        90       5         0.6           0.034
  byproducts                                                

  Sugarcane ,     CC       75       10        0.2           0.027
  molasses                                                  

  Untreated       CC       NA       70        NA            -0-

  Soybean, seed   PC       89       5         0.02          0.001
  (meal)                                                    

  **Total**                         **100**                 **0.961**

  **Dairy Cattle                                            
  R: 45%; CC: 45                                            
  %; PC: 10%**                                              

  Alfalfa, hay    R        89       20        8.0           1.80

  Alfalfa,        R        35       15        3.0           1.29
  forage/silage                                             

  Almond, hulls   R        90       10        0.7           0.08

  Sugarcane ,     CC       75       10        0.2           0.027
  molasses                                                  

  Untreated       CC       NA       35        NA            -0-

  Cotton,         PC       90       10        0.02          0.002
  undelinted seed                                           

  **Total**                         **100**                 **3.19**

  **Poultry CC:                                             
  75-80 %; PC:                                              
  20-25%                                                    
  (normally no R,                                           
  some                                                      
  exceptions)**                                             

  Untreated       CC       NA       75        NA            -0-

  Peanut,         PC       N/A      25        0.02          0.005
  meal/soybean                                              
  seed/meal                                                 

  **Total**                         **100**                 **0.005**

  **Swine CC:                                               
  80-85 %; PC:                                              
  15-20%**                                                  

  Untreated       CC       NA       80        NA            -0-

  Peanut,         PC       N/A      20        0.02          0.004
  meal/soybean                                              
  seed/meal                                                 

  **Total**                         **100**                 **0.004**
  --------------------------------------------------------------------------

All data are based on Table 1 Feedstuffs (October 2006), a revision of
feedstuffs data found in Table 1 (OPPTS Residue Chemistry Test Guideline
180.1000). Residue levels for beef and dairy cattle are corrected for
moisture content and are determined by formula: tolerance / % dry matter
(DM) x % in diet. Residue levels for poultry and swine are considered
"as-is" and are determined by formula: tolerance x % in diet. R =
roughage; CC = carbohydrate concentrate; PC = protein concentrate.

**Cattle:** In the submitted cattle feeding study, lactating Holstein
dairy cows (3 cows/dose group) were dosed orally with flumioxazin (TGAI,
99.1% ai) via capsules at levels equivalent to 2, 6 and 20 ppm in their
diet for 28 consecutive days. These dose levels are respectively
equivalent to 0.6x, 1.9x, and 6.3x the TDB for dairy cattle. Cows were
dosed once a day following the a.m. milking, and the actual dose for
each cow was based on their average feed consumption (dry wt. basis)
during the acclimation period. Composited samples of milk were collected
from each cow on Study Days: -1 (pre-dosing), 1, 2, 4, 7, 10, 14, 17,
21, 24 and 28, and subsamples of whole milk from Day 24 were centrifuged
to obtain cream and skim milk samples. Within 24 hours of receiving the
final dose, cows were sacrificed and samples of liver, kidney,
composited muscle, and composited fat were collected from each animal
and stored at -20ºC. As all samples were analyzed within 30 days of
collection, supporting storage stability data are not required.

Residues of flumioxazin and its two hydroxy metabolites
(3-OH-flumioxazin and 4-OH-flumioxazin) were determined in milk and
tissues using two related LC/MS/MS methods, Valent Methods RM-30MK for
milk and RM-30T for tissues. These methods were adequately validated in
conjunction with the analysis of feed study samples. Recoveries from
milk, cream and skim milk averaged 84-92% (± 1-9%) for flumioxazin,
89-95% (± 8-11%) for 3-OH-flumioxazin, and 84-93% (± 6-10%) for
4-OH-flumioxazin. Recoveries from tissues averaged 77-88% (± 3-12%) for
flumioxazin, 85-102% (± 12-25%) for 3-OH-flumioxazin, and 96-102% (±
17-20%) for 4-OH-flumioxazin. For each analyte, the validated LOQ in
milk and tissues is 0.02 ppm, and the reported LOD is 0.01 ppm.

Following oral dosing with flumioxazin at a level equivalent to 20 ppm
in the diet (6.3x TDB), residues of flumioxazin, 3-OH-flumioxazin and
4-OH-flumioxazin were each non-detectable (\<0.01 ppm) in all samples of
milk, skim milk, cream, liver, kidneys, muscle and fat from all three
cows. As residues were \<LOD in the 20 ppm dose group, samples of milk
and tissues from the 2 and 6 ppm dose groups were not analyzed.

***Conclusions*** The submitted cattle feeding study is adequate. As
residues of flumioxazin and its two hydroxy metabolites were \<LOD in
all samples of milk and tissues from cattle dosed for 28 days at levels
equivalent to 20 ppm in their diet (6.3x TDB), quantifiable residues are
unlikely to occur in cattle, goats, horse, or sheep. Therefore,
tolerances for flumioxazin residues are not required in commodities from
cattle, goats, hogs, horses or sheep (40 CFR §180.6\[a\]\[3\]).

[]{.mark}

In addition, results from the available poultry metabolism study, in
which hens were dosed for 14 days at 9.0 ppm (1,800x TDB), indicate that
quantifiable residues are unlikely to occur in eggs or poultry tissues.
Therefore, tolerances for flumioxazin residues are also not required in
eggs or poultry tissues (40 CFR §180.6\[a\]\[3\]).

**860.1500 Crop Field Trials**

**45375505.der, W. Drew (Almond)**

**46133901.der, W. Drew (dry bulb onion)**

**46889604.der, D. Rate, 19/SEP/2007 (Alfalfa)**

**47005101.der, D. Rate, 10/SEP/2007 (Pecan)**

**47005102.der, D. Rate, 07/SEP/2007 (Cantaloupe)**

**47005103.der, D. Rate, 07/SEP/2007 (Dry beans)**

**47005104.der, D. Rate, 10/SEP/2007 (Blueberry)**

**47005105.der, D. Rate, 07/SEP/2007 (Asparagus)**

**47005106.der, D. Rate, 07/SEP/2007 (Tomato)**

**47005107.der, D. Rate, 07/SEP/2007 (Pepper)**

Valent has submitted new field trail data on alfalfa and IR-4 has
submitted new field trial data on pecans, cantaloupes, dry beans,
blueberries, asparagus, tomatoes and peppers. The pecan data will be
used in conjunction with data from the previously reviewed almond field
trials (DP Num: 301247, W. Drew, 23/JUL/2004) to support a use on the
tree nuts crop group. The results from these studies are discussed below
and summarized in Table 6. In addition, data from the previously
reviewed bulb onion field trials (DP Num: 301247, W. Drew, 23/JUL/2004)
will be used to evaluate the proposed label amendment for garlic. Number
range CHAPTER

<table style="width:100%;">
<colgroup>
<col style="width: 17%" />
<col style="width: 16%" />
<col style="width: 7%" />
<col style="width: 4%" />
<col style="width: 9%" />
<col style="width: 9%" />
<col style="width: 9%" />
<col style="width: 9%" />
<col style="width: 8%" />
<col style="width: 9%" />
</colgroup>
<thead>
<tr class="header">
<th colspan="10"><strong>Table 6. Summary of Residue Data from Crop
Field Trials with Flumioxazin (WDG).</strong></th>
</tr>
<tr class="odd">
<th rowspan="2">Crop matrix</th>
<th rowspan="2">Total Applic. Rate (lb ai/A)</th>
<th rowspan="2">PHI (days)</th>
<th colspan="7">Residue Levels (ppm) <sup>1</sup></th>
</tr>
<tr class="header">
<th>n</th>
<th>Min.</th>
<th>Max.</th>
<th>HAFT</th>
<th>Median</th>
<th>Mean</th>
<th>Std. Dev.</th>
</tr>
</thead>
<tbody>
<tr class="odd">
<td colspan="10"><strong>Alfalfa (proposed use = 0.25 lb ai/A total
application rate, 25-day PHI)</strong></td>
</tr>
<tr class="even">
<td rowspan="3">Forage</td>
<td rowspan="3">0.12-0.26 <sup>3</sup></td>
<td>25</td>
<td>2</td>
<td>24</td>
<td>0.02</td>
<td>0.80</td>
<td>0.80</td>
<td>0.12</td>
<td>0.18</td>
</tr>
<tr class="odd">
<td>60</td>
<td>3</td>
<td>26</td>
<td>&lt;0.01</td>
<td>0.19</td>
<td>0.14</td>
<td>0.02</td>
<td>0.03</td>
</tr>
<tr class="even">
<td>113</td>
<td>4</td>
<td>26</td>
<td>&lt;0.01</td>
<td>0.09</td>
<td>0.04</td>
<td>0.01</td>
<td>0.02</td>
</tr>
<tr class="odd">
<td rowspan="3">Hay</td>
<td rowspan="3">0.12-0.26 <sup>3</sup></td>
<td>25</td>
<td>2</td>
<td>24</td>
<td>0.06</td>
<td>1.60</td>
<td>1.50</td>
<td>0.27</td>
<td>0.48</td>
</tr>
<tr class="even">
<td>60</td>
<td>3</td>
<td>26</td>
<td>&lt;0.01</td>
<td>0.09</td>
<td>0.08</td>
<td>0.03</td>
<td>0.03</td>
</tr>
<tr class="odd">
<td>113</td>
<td>4</td>
<td>22</td>
<td>&lt;0.01</td>
<td>0.15</td>
<td>0.13</td>
<td>0.01</td>
<td>0.03</td>
</tr>
<tr class="even">
<td colspan="10"><strong>Tree nuts (proposed use = 0.75 lb ai/A total
application rate, 60-day PHI)</strong></td>
</tr>
<tr class="odd">
<td>Pecan</td>
<td>0.751-0.769</td>
<td>42-61 <sup>4</sup></td>
<td>10</td>
<td>&lt;0.02</td>
<td>&lt;0.02</td>
<td>&lt;0.02</td>
<td>0.02</td>
<td>0.02</td>
<td>--</td>
</tr>
<tr class="even">
<td>Almond</td>
<td rowspan="2">0.749-0.758</td>
<td rowspan="2">60-61</td>
<td>8</td>
<td>&lt;0.01</td>
<td>&lt;0.01</td>
<td>&lt;0.01</td>
<td>0.01</td>
<td>0.01</td>
<td>--</td>
</tr>
<tr class="odd">
<td>Almond, hulls</td>
<td>8</td>
<td>&lt;0.01</td>
<td>0.066</td>
<td>0.064</td>
<td>0.034</td>
<td>0.034</td>
<td>0.022</td>
</tr>
<tr class="even">
<td colspan="10"><strong>Melons (proposed use = 0.25 lb ai/A total
application rate, No PHI)</strong></td>
</tr>
<tr class="odd">
<td>Cantaloupe</td>
<td>0.245-0.256</td>
<td>36-69</td>
<td>16</td>
<td>&lt;0.02</td>
<td>&lt;0.02</td>
<td>&lt;0.02</td>
<td>0.02</td>
<td>0.02</td>
<td>--</td>
</tr>
<tr class="even">
<td colspan="10"><strong>Dry Beans (proposed use = 0.093 lb ai/A total
application rate, 5-day PHI)</strong></td>
</tr>
<tr class="odd">
<td>Beans, dry</td>
<td>0.091-0.096</td>
<td>4-6</td>
<td>26</td>
<td>&lt;0.02</td>
<td>0.05</td>
<td>0.05</td>
<td>0.02</td>
<td>0.02</td>
<td>0.01</td>
</tr>
<tr class="even">
<td colspan="10"><p><strong>Bushberries: Lowbush, proposed use = 0.40 lb
ai/A total application rate, No PHI</strong></p>
<p><strong>Highbush, proposed use =0.75 lb ai/A total application rate,
7-day PHI</strong></p></td>
</tr>
<tr class="odd">
<td>Blueberry, lowbush</td>
<td>0.400</td>
<td>99</td>
<td>2</td>
<td>&lt;0.02</td>
<td>&lt;0.02</td>
<td>&lt;0.02</td>
<td>0.02</td>
<td>0.02</td>
<td>--</td>
</tr>
<tr class="even">
<td>Blueberry, highbush</td>
<td>0.744-0.797</td>
<td>6-8</td>
<td>10</td>
<td>&lt;0.02</td>
<td>&lt;0.02</td>
<td>&lt;0.02</td>
<td>0.02</td>
<td>0.02</td>
<td>--</td>
</tr>
<tr class="odd">
<td colspan="10"><strong>Asparagus (proposed use =0.375 lb ai/A total
application rate, 14-day PHI)</strong></td>
</tr>
<tr class="even">
<td rowspan="2">Asparagus</td>
<td>0.190-0.197</td>
<td rowspan="2">8-20 <sup>5</sup></td>
<td>16</td>
<td>&lt;0.02</td>
<td>&lt;0.02</td>
<td>&lt;0.02</td>
<td>0.02</td>
<td>0.02</td>
<td>--</td>
</tr>
<tr class="odd">
<td>0.380-0.404</td>
<td>16</td>
<td>&lt;0.02</td>
<td>&lt;0.02</td>
<td>&lt;0.02</td>
<td>0.02</td>
<td>0.02</td>
<td>--</td>
</tr>
<tr class="even">
<td colspan="10"><strong>Fruiting vegetables, including okra (proposed
use = 0.25 lb ai/A total, 21-day PHI)</strong></td>
</tr>
<tr class="odd">
<td>Tomato</td>
<td>0.244-0.259</td>
<td>15-21 <sup>6</sup></td>
<td>24</td>
<td>&lt;0.02</td>
<td>&lt;0.02</td>
<td>&lt;0.02</td>
<td>0.02</td>
<td>0.02</td>
<td>--</td>
</tr>
<tr class="even">
<td><p>Peppers</p>
<p>(Bell and Non-Bell)</p></td>
<td>0.246-0.259</td>
<td>15-21 <sup>6</sup></td>
<td>18</td>
<td>&lt;0.02</td>
<td>&lt;0.02</td>
<td>&lt;0.02</td>
<td>0.02</td>
<td>0.02</td>
<td>--</td>
</tr>
</tbody>
</table>

^1^ With the exception of the almond field trials, the validated method
LOQ is 0.02 ppm. For almond nutmeats and hulls, the LOQ was 0.01 ppm.
For calculation of the median, mean, and standard deviation, the LOQ was
used for samples with residues \<LOQ.

^2^ HAFT = Highest Average Field Trial.

^3^ All 12 alfalfa field trials included a single application at
0.12-0.13 lb ai/A following the 1^st^ cutting, and six of the field
trials also included an earlier application to dormant alfalfa at
0.12-0.13 lb ai/A for a total of 0.24-0.26 lb ai/A.

^4^ Pecan samples were collected at a 59-61 day PHI, with the exception
of one site (42 day PHI).

^5^ Samples were collected at a 19-21 day PHI, with the exception of one
site (15 day PHI) each for tomatoes and peppers.

^6^ For asparagus, 12 out of 16 samples were harvested at a 14-15 day
PHI.

**Bulb Vegetables (Group 3)**

**Garlic** For the currently registered preemergence use of flumioxazin
on garlic, IR-4 is requesting that the use directions be amended to
increase the maximum application rate to 0.38 lb ai/A. The current use
on garlic is supported by bulb onion field trial data, which were
previously reviewed under an earlier petition (DP Num: 301247, W. Drew,
23/JUL/2004).

In 9 bulb onion trials conducted during 2001-2002 in EPA growing Regions
1, 2, 5, 6, 9, 10 and 11, flumioxazin (51% WDG) was applied to bulb
onions as a two postemergence broadcast applications at 0.09-0.10 lb
ai/A, for a total use rate of 0.185-0.200 lb ai/A. The first application
was made at the 2^nd^ leaf stage and the second application was made
during vegetative development at RTIs of 29-78 days. The applications
were made using ground equipment at spray volumes of 16-42 gal/A, and
each application included the use of NIS adjuvant at 0.25% of the spray
volume. Control and duplicate treated samples of bulb onions were
harvested at normal maturity at a 42-49 day PHI. Samples were stored
frozen up to 124 days, a duration supported by available storage
stability data.

[]{.mark}

The GC/NPD method (RM-30A-1) used for determining flumioxazin residues
in/on onions was adequately validated in conjunction with the field
trials. The validated LOQ for flumioxazin was 0.02 ppm in/on bulb
onions, and the stated LOD was 0.009 ppm.

[]{.mark}

Following two postemergence applications totaling 0.185-0.200 lb ai/A,
residues were \<0.02 ppm in/on 18 samples of bulb onions harvested at a
42-to 49-day PHI.

Although the bulb onion data are from field trials that were conducted
at only 0.5x the proposed maximum use rate for garlic, the bulb onion
data will adequately support the requested increase in the use rate for
garlic because the applications to onions occurred at a much later
growth stage than allowed for garlic, and residues in/on all onion
samples were \<LOQ. The residue data on onions reflect postemergence
applications with PHIs of 42-49 days, whereas, the use on garlic is for
a single preemergence application, and the typical planting to harvest
interval for garlic is approximately 8 months (250 days).

**Legume Vegetables (Group 6)**

**Dry Beans:** IR-4 submitted field trial data for flumioxazin on dry
beans. In 12 field trials conducted during 2003 in EPA growing Regions 1
(one trial; NY), 5 (3 trials; OH, ND), 7 (4 trials; NE, ND), 8 (2
trials; CO), 10 (one trial; CA) and 11 (one trial; ID), flumioxazin (51%
WDG) was applied to dry bean varieties as a single pre-harvest,
broadcast application at 0.091-0.096 lb ai/A (1x rate). The applications
were made using ground equipment at volumes of 10-35 gal/A, and each
application included the use of a COC at 0.6-2.5% of the spray volume.
The beans were cut at normal commercial maturity following a 4- to 6-day
PHI, and dried prior to shelling. Beans were shelled either by hand or
mechanically, and duplicate control and treated samples of dry beans
were collected. Samples were stored frozen up to 309 days, a duration
supported by available storage stability data.

[]{.mark}

The GC/NPD method (RM-30A-3) used for determining flumioxazin residues
in/on dry beans was adequately validated in conjunction with the field
trials. The average concurrent recovery of flumioxazin was 107% with a
standard deviation of 11%. The validated method LOQ for flumioxazin was
0.02 ppm in/on dry beans, and the statistically calculated LOD was 0.007
ppm.

[]{.mark}

Following a single pre-harvest broadcast application of flumioxazin
(WDG) at 0.091-0.096 lb ai/A, residues were ND-0.05 ppm in/on 26 samples
of dried beans harvested at a 4- to 6-day PHI. Residues were \<LOQ
(\<0.02 ppm) in/on 22 of the 26 samples. Average residues were 0.02 ppm
and the HAFT residues were 0.05 ppm.

**Fruiting Vegetables, except Cucurbits (Group 8)**

**Tomatoes:** IR-4 submitted field trial data for flumioxazin on the
representative crop of tomatoes. In 12 field trials conducted during the
2003 growing season in EPA growing Regions 1 (one trial; NY), 2 (one
trial; SC), 3 (2 trials; FL), 5 (one trial; WI) and 10 (7 trials; CA),
flumioxazin (51% WDG) was applied to tomatoes as two soil applications
directed to row middles at 0.120-0.134 lb ai/A/application, for a total
use rate of 0.244-0.259 lb ai/A (1x rate). The initial application was
made at seedling emergence, transplanting, or during early vegetative
development, and the second application was made approximately 21 days
prior to crop maturity, for RTIs of 45-103 days. At one field site, an
additional plot was treated at an exaggerated rate of 0.621-0.689 lb
ai/A, for a total of 1.25 lb ai/A (5x rate). Applications were made
using ground equipment at volumes of 16-32 gal/A, and each application
included the use of a COC at 1% v/v of the spray volume. Single control
and duplicate treated samples were harvested at a 19- to 21-day PHI,
with the exception of one test where samples were harvested at a 15-day
PHI due to weather conditions. Samples were stored frozen up to 204
days, a duration supported by available storage stability data.

[]{.mark}

The GC/NPD method (RM-30A-3) used for determining flumioxazin residues
in/on tomatoes was adequately validated in conjunction with the field
trials. The validated method LOQ for flumioxazin in/on tomatoes was 0.02
ppm, and the statistically calculated LOD was 0.01 ppm.

[]{.mark}

Following two soil-directed applications of flumioxazin (WDG) totaling
0.244-0.259 lb ai/A (1x rate), residues were \<LOQ in/on all samples of
tomatoes harvested at 15-21 DAT. Based on an LOQ of 0.02 ppm, average
and median residues were 0.02 ppm. Residues were also \<LOQ in/on the
two tomato samples harvested from the plot treated at 1.25 lb ai/A (5x
rate).

**Peppers:** IR-4 submitted field trial data for flumioxazin on the
representative crop of peppers. In 9 field trials conducted during 2003
growing season in EPA growing Regions 2 (2 trials; NC, GA), 3 (one
trial; FL), 6 (2 trials; TX), 8 (one trial; CO) and 10 (3 trials; CA,
NM), flumioxazin (51% WDG) was applied to bell and non-bell peppers as
two soil applications directed to row middles at 0.121-0.131 lb
ai/A/application, for a total use rate of 0.246-0.259 lb ai/A (1x rate).
The initial application was made to seedlings or transplants during
early vegetative development, and the second application was made
approximately 21 days prior to crop maturity, for RTIs of 42-82 days.
Applications were made using ground equipment at volumes of 12-26 gal/A,
and each application included the use of a COC at 1% v/v of the spray
volume. Duplicate control and treated samples were harvested at a 19- to
21-day PHI, with the exception of one test where samples were harvested
at a 15-day PHI due to fruit rot. Pepper samples were stored frozen up
to 807 days, and the storage durations are supported by the available
storage stability data.

[]{.mark}

The GC/NPD method (RM-30A-3) used for determining flumioxazin residues
in/on peppers was adequately validated in conjunction with the field
trials. The average method validation recovery of flumioxazin from
peppers was 87% with a standard deviation of 19%. The validated LOQ for
flumioxazin in/on peppers was 0.02 ppm, and the statistically calculated
LOD was 0.007 ppm.

Following two soil-directed applications of flumioxazin (WDG) to peppers
at rates totaling 0.246-0.259 lb ai/A (1x rate), residues were
non-detectable (\<0.007 ppm) for in/on all samples harvested at a 15- to
21-day PHI. Even if residues are corrected to account for a 19% decline
during storage, residues in/on all pepper samples would still be \<0.009
ppm.

**Melon (Subgroup 9A)**

**Cantaloupes:** IR-4 submitted field trial data for flumioxazin on the
representative crop cantaloupes. In eight field trials conducted during
2003 in EPA growing Regions 2 (one trial; NC), 5 (one trial; MI), 6 (2
trials; TX) and 10 (4 trials; CA, NM), flumioxazin (51% WDG) was applied
to cantaloupes as two soil applications directed to row middles at
0.121-0.130 lb ai/A/application, for a total use rate of 0.245-0.256 lb
ai/A (1x rate). The initial application was made either preplant or
preemergence, and the second application was made during later
vegetative development or at blooming, for RTIs of 30-47 days.
Applications were made using ground equipment at volumes of 20-32 gal/A,
and did not include the use of any adjuvant. Duplicate control and
treated samples were harvested following a 36- to 69-day PHI. Samples
were stored frozen up to 125 days, a duration supported by available
storage stability data.

[]{.mark}

The GC/NPD method (RM-30A-3) used for determining flumioxazin residues
in/on cantaloupes was adequately validated in conjunction with the
analysis of field trial samples. The validated LOQ for flumioxazin was
0.02 ppm, and the statistically calculated LOD was 0.008 ppm.

Following two soil-directed applications of flumioxazin (WDG) totaling
0.245-0.256 lb ai/A, residues were non-detectable (\<0.008 ppm) in/on
all 16 samples of cantaloupes harvested at 36-69 DAT. Based on an LOQ of
0.02 ppm, average and median residues were 0.02 ppm.

**Bushberries (Subgroup 13B).**

**Blueberries:** IR-4 submitted field trial data for flumioxazin on the
representative crop blueberries. A total of 6 field trials were
conducted on lowbush (1 test) and highbush (5 tests) blueberries during
2003 in EPA growing Regions 1 (one trial; ME), 2 (2 trials; NJ,NC), 5 (2
trials; MI), and 12 (one trial; OR). In the lowbush blueberry test,
flumioxazin (51% WDG) was applied to dormant plants as a single
broadcast application at 0.40 lb ai/A. In the highbush blueberry tests,
flumioxazin (51% WDG) was applied as two soil-directed applications at
0.370-0.405 lb ai/A/application, for a total use rate of 0.744-0.797 lb
ai/A (1x rate). The first application was made around bud break and
flowering and the second application was made 50-113 days later during
fruit development. Applications were made using ground equipment at
volumes of 20-32 gal/A and did not include the use of an adjuvant.
Duplicate control and treated samples of blueberries were harvested at
either a 99-day PHI in the lowbush test or at a 6- to 8-day PHI in the
highbush tests. Samples were stored frozen up to 176 days, a duration
supported by available storage stability data.

[]{.mark}

The GC/NPD method (RM-30A-3) used for determining flumioxazin residues
in/on blueberries was adequately validated in conjunction with the
analysis of field trial samples. The validated LOQ for flumioxazin in/on
blueberries was 0.02 ppm, and the statistically calculated LOD was 0.006
ppm.

Following a single broadcast application to dormant plants at 0.40 lb
ai/A, flumioxazin residues were non-detectable (ND) in/on two samples of
lowbush blueberries harvested at a 99-day PHI. Residues were \<LOQ
(\<0.02 ppm) in/on 10 samples of highbush blueberries harvested 6-8 days
after the second of two soil-directed applications totaling 0.744-0.797
lb ai/A. Average flumioxazin residues were \<0.02 ppm in/on both lowbush
and highbush blueberries.

**Tree Nuts (Group 14)**

**Almonds:** The almond field trail data were previously reviewed under
an earlier petition (DP Num: 301247, W. Drew, 23/JUL/2004). A total of 5
field trials were conducted on almonds during 1999 in CA (Zone 10). In
four tests, flumioxazin (51% WDG) was applied to almond trees as two
soil-directed applications during nut development at 0.375 lb
ai/A/application, and RTIs of 60 days, for a total use rate of 0.75 lb
ai/A/season (1x rate). In a fifth test, flumioxazin (51% WDG) was
applied similarly at rates of 0.75 lb ai/A, for a total use rate of 1.5
lb ai/A/season (2x rate). Applications were made using ground equipment
at spray volumes of 18-25 gal/A, and included the use of a COC as an
adjuvant. Control and treated samples of nuts and hulls were harvested
from four of the tests at a 60- to 61-day PHI. Samples were stored
frozen up to 185 days, a duration supported by available storage
stability data.

The GC/NPD method (RM-30A-1) used for determining flumioxazin residues
in/on almond nutmeats and hulls was adequately validated in conjunction
with the field trials. The validated LOQ for flumioxazin in/on almond
nutmeats and hulls was 0.01 ppm, and the reported LOD was 0.005 ppm.

Following two soil-directed applications of flumioxazin (WDG) during nut
development at rates totaling 0.75 lb ai/A (1x rate), flumioxazin
residues were \<LOQ (ND-0.007 ppm) in/on 8 samples of nutmeats and
ND-0.066 ppm in/on 8 samples of hulls. For the 2x-rate applications,
residues were 0.006 and 0.007 ppm in/on two nutmeat samples and 0.487
and 0.617 ppm in/on 2 hull samples.

**Pecans:** IR-4 submitted additional field trial data for flumioxazin
on pecans. In 5 field trials conducted during 2003 in EPA growing
Regions 2 (2 trials; NC), 4 (one trial; TX), 6 (one trial; LA) and 8
(one trial; NM), flumioxazin (51% WDG) was applied to pecan trees as two
soil-directed applications during nut development at rates of
0.374-0.381 lb ai/A and RTIs of 58-61 days, for a total use rate of
0.751-0.760 lb ai/A (1x rate). Applications were made using ground
equipment at volumes of 22-33 gal/A, and did not include the use of any
spray adjuvant. Duplicate control and treated samples of nuts were
harvested from four of the tests at a 59- to 61-day PHI, and from one
site at a 42-day PHI to prevent predation. Samples were stored frozen up
to 97 days, a duration supported by available storage stability data.

The GC/NPD method (RM-30A-3) used for determining flumioxazin residues
in/on pecans was adequately validated in conjunction with the field
trials. The validated LOQ for flumioxazin in/on pecans was 0.02 ppm, and
the statistically calculated LOD was 0.01 ppm.

Following two soil-directed applications of flumioxazin (WDG) during nut
development at rates totaling 0.751-0.760 lb ai/A, flumioxazin residues
were non-detectable (ND, \<0.01 ppm) in/on all samples of nutmeats
harvested at a 42-61 day PHI.

**Nongrass Animal Feeds (Group 18)**

**Alfalfa:** Valent Corporation submitted field trial data for
flumioxazin on alfalfa from 12 field trials conducted during 2003, 2004
and 2005 in EPA growing Regions 1 (one trial; PA), 2 (one trial; GA), 5
(6 trials; MO, NE, SD, OH, IL), 7 (one trial; ND), 9 (one trial; AZ), 10
(one trial; CA) and 11 (one trial; ID). In the six field trials
conducted during 2003 and 2004 (Trials A-G), flumioxazin (51% WDG) was
applied to alfalfa as two broadcast foliar applications at 0.12-0.13 lb
ai/A/application, for a total use rate of 0.24-0.26 lb ai/A. One test
site (Trial A) also include a plot using exaggerated application rates
of 0.25 lb ai/A, for a total use rate of 0.5 lb ai/A/season. The initial
application in the 2003/2004 trials was made to dormant or immature
alfalfa approximately 25 days prior to the 1^st^ cutting, and the second
application was made to stubble and new growth, 6-8 days following the
1^st^ cutting, for RTIs of 31-41 days. Owing to the excessive
phytotoxicity noted in the 2003/2004 tests, the application regime was
changed for the six field trails conducted in 2005. In these tests,
flumioxazin (51% WDG) was applied to the new growth 7-9 days after the
1^st^ cutting as a single broadcast foliar application at 0.12-0.13 lb
ai/A. Two test sites during 2005 (Trials H and J) also include plots
using an exaggerated application of 0.25 lb ai/A. All applications were
made using ground equipment at volumes of 15-26 gal/A. The initial
application in the 2003/2004 tests and the single application in the
2005 tests included the use of a non-ionic surfactant (NIS) as an
adjuvant at 0.25% v/v.

Following the application of flumioxazin to alfalfa stubble/new growth
after the 1^st^ cutting, three additional cuttings of alfalfa were
obtained from each test at normal harvest intervals. The 2^nd^, 3^rd^,
and 4^th^ cuttings were made following a 24- to 26-day PHI, 45- to
70-day PHI, and a 71- to 128-day PHI, respectively. At each of these
cuttings, single control and duplicate treated samples of forage and hay
were collected. Duplicate treated samples of forage and hay were also
collected at 3, 15, 24, 35, 65 and 107 DAT from one test in 2003 to
examine residue decline. In all tests, the forage samples were
immediately frozen after collection, and the hay samples were
field-dried for 1-9 days prior to collection. Forage and hay samples
were stored frozen for up to 455 days prior to analysis, a duration
supported by the submitted storage stability data.

The GC/NPD method (RM-30A-3) used for determining flumioxazin residues
in/on alfalfa forage and hay was adequately validated in conjunction
with the analysis of field trial samples. The validated method LOQ for
flumioxazin in/on alfalfa forage and hay was 0.02 ppm, and the reported
LOD was 0.01 ppm.

Although the 2003/2004 field trials included an extra application of
flumioxazin to dormant or emergent alfalfa, all the field trials
included an application at 0.12-0.13 lb ai/A to alfalfa approximately 7
days following the 1^st^ cutting of the season. The resulting
flumioxazin residues in/on forage and hay from the 2^nd^ cutting (\~25
day PHI), and from the subsequent 3^rd^ and 4^th^ cuttings were similar
across all tests, regardless of whether or not an early-season
application was made. Residues of flumioxazin in/on forage were
\<0.02-1.70 ppm from the 2^nd^ cutting harvested at 24-26 DAT,
\<0.02-0.19 ppm from the 3^rd^ cutting harvested at 45-70 DAT, and
\<0.02-0.06 ppm from the 4^th^ cutting harvested at 71-128 DAT. Residues
in/on hay from the three cuttings were 0.06-5.50 ppm at 24-26 DAT,
\<0.02-0.09 ppm at 45-70 DAT, and \<0.02-0.15 ppm at 71-128 DAT. Average
flumioxazin residues in/on alfalfa from the 2^nd^, 3^rd^, and 4^th^
cuttings were respectively 0.18, 0.03, and 0.02 ppm for forage and 0.48,
0.04, and 0.03 ppm for hay.

**Miscellaneous Crops**

**Asparagus:** IR-4 submitted field trial data for flumioxazin on
asparagus from 8 field trials conducted during the 2003 and 2004 growing
seasons in EPA growing Regions 2 (one trial; NJ), 5 (2 trials; MI), 10
(3 trials; CA) and 11 (2 trials; WA). In each test, flumioxazin (51%
WDG) was applied as a single broadcast application to dormant or
recently cut asparagus at approximately 14-15 days prior to the
anticipated harvest. Two plots were treated at each test site at rates
of either 0.190-0.197 lb ai/A or 0.380-0.404 lb ai/A. Applications were
made using ground equipment at volumes of 20-37 gal/A, and an adjuvant
was not used for any application. Single control and duplicate treated
samples were harvested following an 8- to 20-day PHI, with most samples
being harvested at a 14- to 15-day PHI. Samples were stored frozen up to
110 days, a duration supported by available storage stability data.

[]{.mark}

The GC/NPD method (RM-30A-3) used for determining flumioxazin residues
in/on asparagus was adequately validated in conjunction with the field
trials. The validated LOQ for flumioxazin in/on asparagus was 0.02 ppm,
and the statistically calculated LOD was 0.005 ppm.

[]{.mark}

Following a single early-season application of flumioxazin (WDG) to
dormant or freshly cut asparagus at either 0.190-0.197 lb ai/A or
0.380-0.404 lb ai/A (0.5x and 1x rates), flumioxazin residues were \<LOQ
in/on all samples of asparagus from both the low and high application
rates.

***Conclusions:*** The available almond, pecan, cantaloupe, dry bean,
blueberry, asparagus, tomato, and pepper field trials are adequate and
support the proposed use patterns. An adequate number of tests were
conducted on each crop in the appropriate geographical regions. Samples
were analyzed for the residue of concern using an adequate method, and
sample storage conditions and durations were supported by the
available/submitted storage stability data. As residues were \<LOQ (0.02
ppm) in/on all commodities, except dry beans and almond hulls, the data
support the proposed 0.02 ppm tolerances in the following commodities:
tree nuts (group 14), melons (subgroup 9A), asparagus, fruiting
vegetables (group 8), okra, and assorted types of bushberries.

Utilizing the tolerance harmonization spreadsheet, the available residue
data on dry beans does not conform to lognormality; thus, lognormality
is rejected. Based on the CA method (µ + 3σ), the residue data will
support a tolerance of 0.05 ppm.

The alfalfa field trial data are also adequate. A sufficient number of
field trials are available. However, the tolerance harmonization
spreadsheet will be used and the highest residue calculated from each
set or combination will represent the recommended tolerance. Utilizing
the tolerance harmonization spreadsheet in this way, the available
residue data on alfalfa supports tolerances of 3.0 ppm for forage and
8.0 ppm for hay.

In addition, the available bulb onion field trial data will support the
requested increase in the use rate for garlic up to 0.38 lb ai/A, and
the existing 0.02 ppm tolerance in garlic is adequate.

A revised section F will be required for both petitions to correct
commodity definitions and match the proposed tolerances with the
recommended tolerances as listed in Table 7.

**860.1520 Processed Food and Feed**

Tomato is the only crop associated with the current petitions for which
a processing study is required. No tomato processing study was submitted
with these petitions. However, in one of the tomato field trials,
flumioxazin (WDG) was applied as two soil-directed applications at
0.621-0.689 lb ai/A, for a total use rate of 1.25 lb ai/A (5x rate).
Both applications included the use of a COC at 1% v/v. Residues were
\<0.02 ppm in/on duplicate samples of tomatoes harvested at 21 DAT. As
residues were \<LOQ following applications at a 5x rate, a tomato
processing study is not required, and no tolerances are necessary in
processed tomato commodities.

Number range CHAPTER**860.1650 Submittal of Analytical Reference
Standards**

An analytical reference standard for flumioxazin has been submitted to
the EPA National Pesticide Standards Repository.

**860.1850/860.1900 Confined and Field Accumulation in Rotational
Crops**

Current label directions for both 51% WDG formulations of flumioxazin
specify the following general rotational crop restriction: do not plant
any crop except cotton, peanut, soybean and sugarcane earlier than 30
days after application of flumioxazin. In addition, the labels also
specify a variety of PBIs for different field crops depending on the
application rate. For the highest use rate on any rotated crop (0.38 lb
ai/A), the specified PBIs are 9 months for cotton, field corn, peanut,
rice, sorghum, soybean, sunflower, tobacco and wheat, and 18 months for
all other field crops.

An adequate confined rotational crop study is available reflecting
application of \[THP-^14^C\] flumioxazin at rates of 0.096 and 0.19 lb
ai/A (DP Num: 259593, D. Dotson, 12/MAR/2001).

Following an application of \[^14^C\]flumioxazin at 0.96 lb ai/A, TRRs
were 0.004-0.057 ppm in RACs from representative rotational crops
planted 30 days post-treatment (60 days for lettuce, because of
phytotoxicity). Extraction and analysis of plant samples with TRRs
\>0.01 ppm indicated that the majority of extractable ^14^C-residues
were comprised of unknown polar components each present at ≤0.015 ppm.
Low levels of flumioxazin (≤0.003 ppm) were detected in carrot tops and
wheat chaff and straw, along with trace amounts (\<0.001 ppm) of the
metabolites 482-HA, IMOXA, and 482-CA.

Following an application at 0.19 lb ai/A, TRRs were 0.003-0.072 ppm in
RACs from representative rotational crops planted 30 days post-treatment
(90 days for lettuce and 60 days for carrots, due to phytotoxicity).
Although the highest TRR values were obtained at the 120-day PBI (0.131
ppm in wheat straw), ^14^C-residues generally declined at longer PBIs.
As with the 1x-treated plant samples, the majority of extractable
^14^C-residues were comprised of unknown polar components. Flumioxazin
was detected at ≤0.009 in sample extracts from carrot tops and roots,
and wheat chaff and straw, with the exception of wheat straw (0.033 ppm)
from the 120-day PBI. Other metabolites tentatively identified included:
482-HA (≤0.002 ppm), IMOXA (\<0.001 ppm), 482-CA (\<0.001) in carrot and
wheat samples and SAT-1-OH-482 (0.008 ppm), 1-OH-HPA (0.004 ppm), THPA
(0.004 ppm), and TPA (0.0004 ppm) in wheat straw from later PBIs. Based
on the results from the confined study, HED has determined that the
residue of concern in rotational crops is parent compound.

In the current petitions, the maximum seasonal use rates on melons and
fruiting vegetables (0.25 lb ai/A) and on garlic and asparagus (0.38 lb
ai/A) are higher than utilized in the confined study. However, HED has
previously addressed the adequacy of the current rotational crop
restrictions at these higher use rates under a petition for use on
sugarcane (DP Num: 301247, W. Drew, 23/JUL/2004), which has a maximum
seasonal use rate of 0.38 lb ai/A. The Agency concluded that the higher
use rates (0.25 and 0.38 lb ai/A) are supported by the results from the
confined study conducted at 0.19 lb ai/A, and that field trials for, and
tolerances in, rotational crops are not required.

**860.1550 Proposed Tolerances**

HED determined that the tolerance expression for primary and rotational
crops should include only parent flumioxazin. Tolerances for flumioxazin
residues are currently established on plant commodities at levels
ranging from 0.02 ppm on various commodities to 0.70 ppm on almond hulls
(40 CFR §180.568\[a\]). Number range CHAPTER The tolerances currently
being proposed by Valent and IR-4 are listed below in Table 7, along
with the Agency's recommended tolerance levels.

The recommended tolerance levels for alfalfa forage and hay were
determined using Agency Guidance (*Guidance for Setting Pesticide
Tolerances Based on Field Trial Data* SOP), as all the field trials were
conducted at a \~1x rate and quantifiable residues were detected in
\>90% of the samples. The appropriate tolerances in alfalfa forage and
hay were calculated to be 3.0 and 8.0 ppm, respectively (Appendix II).

Data from the available cattle feeding study, conducted at 20 ppm (6.3x
TDB), indicate that quantifiable residues are unlikely to occur in
cattle, goats, hogs, horses, or sheep. Likewise, the data from the
available poultry metabolism studies, conducted at \>1,800x TDB,
indicate that quantifiable residues are also unlikely to occur in eggs
and poultry tissues. Therefore, tolerances for flumioxazin residues in
livestock commodities are not required for these petitions (40 CFR
§180.6\[a\]\[3\]).

Number range CHAPTERNo international harmonization issues are associated
with these petitions, as there are no established or proposed Canadian,
Mexican or Codex MRLs for residues of flumioxazin in plant commodities
(Appendix I).

+-----------------+--------------+------------+-----------------------+
| **Table 7.      |              |            |                       |
| Tolerance       |              |            |                       |
| Summary for     |              |            |                       |
| Flumioxazin.**  |              |            |                       |
+=================+==============+============+=======================+
| Commodity       | Proposed     | R          | Comments;             |
|                 | Tolerance    | ecommended |                       |
|                 | (ppm)        | Tolerance  | *Correct Commodity    |
|                 |              | (ppm)      | Definition*           |
+-----------------+--------------+------------+-----------------------+
| Alfalfa, forage | 1.0          | 3.0        | Adequate residue data |
|                 |              |            | are available, and    |
|                 |              |            | the tolerances were   |
|                 |              |            | calculated using the  |
|                 |              |            | tolerance             |
|                 |              |            | harmonization         |
|                 |              |            | spreadsheet.          |
|                 |              |            |                       |
|                 |              |            | *Alfalfa, hay*        |
|                 |              |            |                       |
|                 |              |            | *Alfalfa, forage*     |
+-----------------+--------------+------------+-----------------------+
| Alfalfa, hay    | 2.0          | 8.0        |                       |
+-----------------+--------------+------------+-----------------------+
| Tree Nut Crop   | 0.02         | 0.02       | Adequate almond and   |
| Group 14        |              |            | pecan field trial     |
|                 |              |            | data are available.   |
|                 |              |            |                       |
|                 |              |            | *Nut, tree, group 14* |
+-----------------+--------------+------------+-----------------------+
| Melon subgroup  | 0.02         | 0.02       | Adequate cantaloupe   |
| 9A              |              |            | field trial data are  |
|                 |              |            | available.            |
|                 |              |            |                       |
|                 |              |            | *Melon, subgroup 9A*  |
+-----------------+--------------+------------+-----------------------+
| Asparagus       | 0.02         | 0.02       | Adequate asparagus    |
|                 |              |            | field trial data are  |
|                 |              |            | available.            |
|                 |              |            |                       |
|                 |              |            | *Asparagus*           |
+-----------------+--------------+------------+-----------------------+
| Bean, dry, seed | 0.06         | 0.05       | Adequate dry bean     |
|                 |              |            | field trial data are  |
|                 |              |            | available. As         |
|                 |              |            | residues were \<LOQ   |
|                 |              |            | in/on 22 out of 26    |
|                 |              |            | samples, the          |
|                 |              |            | recommended tolerance |
|                 |              |            | was determined using  |
|                 |              |            | the CA method (μ +    |
|                 |              |            | 3σ).                  |
|                 |              |            |                       |
|                 |              |            | *Bean, dry, seed*     |
+-----------------+--------------+------------+-----------------------+
| Fruiting        | 0.02         | 0.02       | Adequate tomato and   |
| Vegetable Crop  |              |            | pepper field trial    |
| Group 8         |              |            | data are available.   |
|                 |              |            |                       |
|                 |              |            | *Vegetable, fruiting, |
|                 |              |            | except cucurbits,     |
|                 |              |            | group 8*              |
+-----------------+--------------+------------+-----------------------+
| Okra            | 0.02         | 0.02       | The tolerance in okra |
|                 |              |            | is supported by the   |
|                 |              |            | available tomato and  |
|                 |              |            | pepper field trial    |
|                 |              |            | data.                 |
+-----------------+--------------+------------+-----------------------+
| Bushberry       | 0.02         | 0.02       | Adequate lowbush and  |
| subgroup 13B    |              |            | highbush blueberry    |
|                 |              |            | field trial data are  |
|                 |              |            | available and support |
|                 |              |            | establishing a        |
|                 |              |            | tolerance in the      |
|                 |              |            | *Bushberry, subgroup  |
|                 |              |            | 13B.*                 |
|                 |              |            |                       |
|                 |              |            | In accordance with    |
|                 |              |            | the Agency's proposed |
|                 |              |            | revisions to the      |
|                 |              |            | Berry Crop Group,     |
|                 |              |            | separate tolerances   |
|                 |              |            | should be established |
|                 |              |            | in new members of the |
|                 |              |            | bushberry subgroup    |
|                 |              |            | 13B, until the        |
|                 |              |            | revised crop group is |
|                 |              |            | approved. However,    |
|                 |              |            | separate tolerances   |
|                 |              |            | are not required in   |
|                 |              |            | the existing members  |
|                 |              |            | of the bushberry      |
|                 |              |            | subgroup.             |
+-----------------+--------------+------------+-----------------------+
| Aronia berry    | 0.02         | 0.02       |                       |
+-----------------+--------------+------------+-----------------------+
| Blueberry,      | 0.02         | None ^1^   |                       |
| lowbush         |              |            |                       |
+-----------------+--------------+------------+-----------------------+
| Blueberry,      | 0.02         | None ^1^   |                       |
| highbush        |              |            |                       |
+-----------------+--------------+------------+-----------------------+
| Buffalo currant | 0.02         | 0.02       |                       |
+-----------------+--------------+------------+-----------------------+
| Chilean guava   | 0.02         | 0.02       |                       |
+-----------------+--------------+------------+-----------------------+
| Currant, black  | 0.02         | None ^1^   |                       |
+-----------------+--------------+------------+-----------------------+
| Currant, red    | 0.02         | None ^1^   |                       |
+-----------------+--------------+------------+-----------------------+
| Elderberry      | 0.02         | None ^1^   |                       |
+-----------------+--------------+------------+-----------------------+
| European        | 0.02         | 0.02       |                       |
| barberry        |              |            |                       |
+-----------------+--------------+------------+-----------------------+
| Gooseberry      | 0.02         | None ^1^   |                       |
+-----------------+--------------+------------+-----------------------+
| Highbush        | 0.02         | 0.02       |                       |
| cranberry       |              |            |                       |
+-----------------+--------------+------------+-----------------------+
| Honeysuckle     | 0.02         | 0.02       |                       |
+-----------------+--------------+------------+-----------------------+
| Jostaberry      | 0.02         | 0.02       |                       |
+-----------------+--------------+------------+-----------------------+
| Juneberry,      | 0.02         | 0.02       |                       |
| including       |              |            |                       |
| Saskatoon berry |              |            |                       |
+-----------------+--------------+------------+-----------------------+
| Lingonberry     | 0.02         | 0.02       |                       |
+-----------------+--------------+------------+-----------------------+
| Native currant  | 0.02         | 0.02       |                       |
+-----------------+--------------+------------+-----------------------+
| Salal           | 0.02         | 0.02       |                       |
+-----------------+--------------+------------+-----------------------+
| Sea buckthorn   | 0.02         | 0.02       |                       |
+-----------------+--------------+------------+-----------------------+

^1^ As a tolerance is being established in bushberry, subgroup 13B,
separate tolerances are not required in the existing members of this
subgroup, including: lowbush and highbush blueberries, currants,
elderberry, gooseberry, and huckleberry.

**References**

Number range CHAPTERDP Num: 194594

Subject: PP#3G4250: New Chemical EUP: V-53482, Flumioxazin on Soybeans.
Evaluation of Analytical Methods and of Residue Data.

From: J. Garbus

To: J. Miller, D. Kenny and A. Koscialski

Dated: 21/SEP/1994

MRID(s): 42884011-42884014, 42884016-42884019

Number range CHAPTERDP Num: None

Subject: PP#G4250: New Chemical EUP: Flumioxazin: Revised Tolerance
Enforcement Method.

From: J. Garbus

To: J. Miller

Dated: 08/JAN/1996

MRID(s): 43935509

Number range CHAPTERDP Num: 259493 and 268181

Subject: PP#s 7F4841 and 0F6171. Tolerance Petitions for the Use of
Flumioxazin on Peanuts, Soybeans, and Sugarcane. Evaluation of Residue
Chemistry and Analytical Methodology

From: D. Dotson

To: D. Kenny and J. Miller

Dated: 12/MAR/2001

MRID(s): 44013001, 44013002, 44295049 - 44295057

Number range CHAPTERDP Num: 272652

Subject: PP#7F4841/0F6171; Flumioxazin in/on Peanuts, Soybeans and
Sugarcane. Conclusions of the 12/20/2000 Meeting of the Metabolism
Assessment Review Committee.

From: R. Loranger

To: Y. Donovan

Dated: 12/MAR/2001

MRID(s): None

DP Number: 301247

Subject: Flumioxazin. Tolerance Petition Requesting Section 3
Registration for Food Use of the Herbicide Flumioxazin on Sugarcane,
Grape, Almond/Pistachio, Mint, Tuberous/Corm Vegetables (Crop Subgroup
1C), and Dry Bulb Onion/Garlic/Shallot. Summary of Analytical Chemistry
and Residue Data. Petitions Numbered 0F06171, 1F06296, 3E06777, 3E06779,
3E6788.

From: W. Drew

To: Joanne Miller/James Stone

Dated: 23/JUL/2004

MRID(s): 45244801, 45375503, 45375504, 45375505, 45375507, 45888501,
46109201, 46114601, 46133901

[]{.mark}

DP Num: 310408, 313783

Subject: Flumioxazin. Tolerance Petitions Requesting Section 3
Registration for Food Use of the Herbicide Flumioxazin on Pome Fruit
(Crop Group 11), Stone Fruit (Crop Group 12), and Strawberries. Summary
of Analytical Chemistry and Residue Data.

From: W. Drew

To: J. Stone, J. Miller and D. Rosenblatt,

Dated: 15/MAR/2006

MRID(s): 46229401, 46229402, 46229403, 46229404, 46229405, 46229406,
46229407, 46229408, 46292501

[]{.mark}

DP Num: None

Subject: Crop Grouping -- Part III: Analysis of the USDA IR-4 Petition
to Amend the Crop Group Regulation 40 CFR §180.41 (c)(13) and Commodity
Definitions \[40 CFR §180.1(h)\] Related to Crop Group Berry.

From: B. Schneider

To: B. Madden

Dated: 28/MAR/2006

MRID(s): None

Number range CHAPTERAttachments:

Appendix I - International Residue Limits Status

Appendix II- Tolerance Spreadsheet Calculations.

**Appendix I**

+-------------------+--------------+-------------------+--------------+
| INTERNATIONAL     |              |                   |              |
| RESIDUE LIMIT     |              |                   |              |
| STATUS            |              |                   |              |
+===================+==============+===================+==============+
| Chemical Name:    | Common Name: | X Recommended     | Date:        |
| 2-\               | Flumioxazin  | tolerance         | 08/22/07     |
| [7-fluoro-3,4-dih |              |                   |              |
| ydro-3-oxo-4-(2-p |              | ⁯Reevaluated       |              |
| ropynyl)-2*H*-1,4 |              | tolerance         |              |
| -benzoxazin-6-yl\ |              |                   |              |
| ]-4,5,6,7-tetrahy |              | ⁯Other             |              |
| dro-1*H*-isoindol |              |                   |              |
| e-1,3(2*H*)-dione |              |                   |              |
+-------------------+--------------+-------------------+--------------+
| Codex Status      |              | U. S. Tolerances  |              |
| (Maximum Residue  |              |                   |              |
| Limits)           |              |                   |              |
+-------------------+--------------+-------------------+--------------+
| √ No Codex        |              | Petition Numbers: |              |
| proposal step 6   |              | 6F7092 and 6E7151 |              |
| or above          |              |                   |              |
|                   |              | DP Numbers:       |              |
|  No Codex        |              | 342963            |              |
| proposal step 6   |              |                   |              |
| or above for the  |              | Other Identifier: |              |
| crops requested   |              | PC Code 129034    |              |
+-------------------+--------------+-------------------+--------------+
| Residue           |              | Reviewer/Branch:  |              |
| definition (step  |              | D. Rate/ RIMUERB  |              |
| 8/CXL): N/A       |              |                   |              |
+-------------------+--------------+-------------------+--------------+
|                   |              | Residue           |              |
|                   |              | definition:       |              |
|                   |              | Flumioxazin       |              |
+-------------------+--------------+-------------------+--------------+
| Crop (s)          | MRL (mg/kg)  | Crop(s)           | Tolerance    |
|                   |              |                   | (ppm)        |
+-------------------+--------------+-------------------+--------------+
|                   |              | Alfalfa, forage   | 3.0          |
+-------------------+--------------+-------------------+--------------+
|                   |              | Alfalfa, hay      | 8.0          |
+-------------------+--------------+-------------------+--------------+
|                   |              | Bean, dry seed    | 0.05         |
+-------------------+--------------+-------------------+--------------+
|                   |              | Nut, tree, group  | 0.02         |
|                   |              | 14                |              |
+-------------------+--------------+-------------------+--------------+
|                   |              | Melon, subgroup   | 0.02         |
|                   |              | 9A                |              |
+-------------------+--------------+-------------------+--------------+
|                   |              | Asparagus         | 0.02         |
+-------------------+--------------+-------------------+--------------+
|                   |              | Vegetable,        | 0.02         |
|                   |              | fruiting, group 8 |              |
+-------------------+--------------+-------------------+--------------+
|                   |              | Okra              | 0.02         |
+-------------------+--------------+-------------------+--------------+
|                   |              | Bushberry,        | 0.02         |
|                   |              | subgroup 13B      |              |
+-------------------+--------------+-------------------+--------------+
|                   |              | Aronia berry      | 0.02         |
+-------------------+--------------+-------------------+--------------+
|                   |              | Buffalo currant   | 0.02         |
+-------------------+--------------+-------------------+--------------+
|                   |              | Chilean guava     | 0.02         |
+-------------------+--------------+-------------------+--------------+
|                   |              | European barberry | 0.02         |
+-------------------+--------------+-------------------+--------------+
|                   |              | Highbush          | 0.02         |
|                   |              | cranberry         |              |
+-------------------+--------------+-------------------+--------------+
|                   |              | Honeysuckle       | 0.02         |
+-------------------+--------------+-------------------+--------------+
|                   |              | Jostaberry        | 0.02         |
+-------------------+--------------+-------------------+--------------+
|                   |              | Juneberry,        | 0.02         |
|                   |              | including         |              |
|                   |              | Saskatoon berry   |              |
+-------------------+--------------+-------------------+--------------+
|                   |              | Lingonberry       | 0.02         |
+-------------------+--------------+-------------------+--------------+
|                   |              | Native currant    | 0.02         |
+-------------------+--------------+-------------------+--------------+
|                   |              | Salal             | 0.02         |
+-------------------+--------------+-------------------+--------------+
|                   |              | Sea buckthorn     | 0.02         |
+-------------------+--------------+-------------------+--------------+
| Limits for Canada |              | Limits for Mexico |              |
+-------------------+--------------+-------------------+--------------+
| √ No Limits       |              | √ No Limits       |              |
|                   |              |                   |              |
| ⁯No Limits for the |              | ⁯No Limits for the |              |
| crops requested   |              | crops requested   |              |
+-------------------+--------------+-------------------+--------------+
| Residue           |              | Residue           |              |
| definition: N/A   |              | definition: N/A   |              |
+-------------------+--------------+-------------------+--------------+
| Crop(s)           | MRL (mg/kg)  | Crop(s)           | MRL (mg/kg)  |
+-------------------+--------------+-------------------+--------------+
|                   |              |                   |              |
+-------------------+--------------+-------------------+--------------+
|                   |              |                   |              |
+-------------------+--------------+-------------------+--------------+
|                   |              |                   |              |
+-------------------+--------------+-------------------+--------------+
| Notes/Special     |              |                   |              |
| Instructions: S.  |              |                   |              |
| Funk,09/07/2007   |              |                   |              |
+-------------------+--------------+-------------------+--------------+

**Appendix II**

  -------------- ------------ --------------- ---------- ------------- ------------- ---------------- ----------------- ------------
  **Table II-1                                                                                                          
  Data used to                                                                                                          
  Set                                                                                                                   
  Tolerances**                                                                                                          

  **Alfalfa,     **Alfalfa,   **Asparagus**   **Bean,    **Tomatos**   **Peppers**   **Canteloupe**   **Blueberries**   **Pecans**
  Hay**          Forage**                     dry seed**                                                                

  **Set 1**      **Set 1**                                                                                              

  0.36           0.800        ND              ND         ND            ND            ND               ND                ND

  0.34           0.790        0.005           ND         ND            ND            ND               ND                ND

  0.27           0.030        0.010           ND         ND            ND            ND               ND                ND

  0.27           0.020        0.010           ND         ND            ND            ND               ND                ND

  0.27           0.130        0.006           ND         ND            ND            ND               ND                ND

  0.17           0.070        0.005           ND         ND            ND            ND               ND                ND

  0.07           0.060        0.009           0.04       ND            ND            ND               ND                ND

  0.06           0.050        0.008           0.03       ND            ND            ND               ND                ND

  0.23           0.240        ND              0.04       ND            ND            ND               ND                ND

  0.18           0.220        ND              0.05       ND            ND            ND               0.008             ND

  1.1            0.140        0.005           0.012      ND            ND            ND               ND                

  1.3            0.120        ND              ND         ND            ND            ND               ND                

  1.4            0.800        ND              0.017      ND            ND            ND                                 

  1.6            0.790        ND              ND         ND            ND            ND                                 

  0.11           0.030        0.012           ND         ND            ND            ND                                 

  0.11           0.020        0.010           ND         ND            ND            ND                                 

  0.23           0.130        0.006           0.010      ND            ND                                               

  0.36           0.070        0.008           0.016      ND            ND                                               

  0.22           0.060        0.010           0.019      ND                                                             

  0.25           0.050        0.009           0.015      ND                                                             

  0.47           0.240        ND              0.016      ND                                                             

  0.45           0.220        ND              0.011      ND                                                             

  0.88           0.140        0.007           0.012      ND                                                             

  0.84           0.120        0.006           0.012      ND                                                             

  **Set 2**      **Set 2**    0.008           0.014                                                                     

  0.360          0.090        0.008           ND                                                                        

  0.340          0.120        0.010                                                                                     

  0.270          0.080        0.013                                                                                     

  0.270          0.160        ND                                                                                        

  0.270          0.120        ND                                                                                        

  0.170          0.120        0.008                                                                                     

  0.070          0.030        0.009                                                                                     

  0.060          0.030                                                                                                  

  0.230          0.090                                                                                                  

  0.180          0.110                                                                                                  

  1.100          0.430                                                                                                  

  1.300          0.350                                                                                                  

  5.500          1.700                                                                                                  

  3.000          1.100                                                                                                  

  0.940          0.260                                                                                                  

  0.510          0.020                                                                                                  

  0.360          0.090                                                                                                  

  0.340          0.120                                                                                                  

  0.270          0.080                                                                                                  
  -------------- ------------ --------------- ---------- ------------- ------------- ---------------- ----------------- ------------

ND = non detectable; LOQ for each matrix is 0.02 ppm. LOQ was used in
the calculation of tolerance when residue was ND. Set 1 = 0.125 lb ai/A;
Set 2 = 0.250 lb ai/A; Set 3 = Set 1 + Set 2.

**Tolerance assessment calculations.**

The Agency's *Guidance for Setting Pesticide Tolerances Based on Field
Trial Data* was utilized for determining appropriate tolerance levels on
alfalfa forage and hay, as less than 10% of the residue values were
below the LOQ in/on forage and hay. However, the tolerance spreadsheet
was not used to calculate tolerances in tree nuts, fruit vegetables,
melons, bushberries, asparagus, or dry beans as residues were \<LOQ
in/on \>80% of the samples from these crops.

The datasets used to establish tolerances for flumioxazin residues on
alfalfa forage and hay consisted of field trial data representing
applications of the appropriate formulations at \~1x proposed 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 application rates, and the PHIs are consistent with the
appropriate stage of maturity and the proposed PHIs for each commodity.
The residue values used to calculate the alfalfa tolerances are provided
in Table II-1.

The datasets for flumioxazin residues in alfalfa forage and hay were
entered into the tolerance spreadsheet. Visual inspection of the
lognormal probability plots indicated that the datasets are reasonably
lognormal, and results from the approximate Shapiro-Francia test
statistic (Figures II-1 and II-2) confirm this assumption. Therefore,
the Log Normal method was used to calculate tolerances of 3.0 ppm in
alfalfa forage and 8.0 ppm in alfalfa hay, based on data from Set 2.

Figure II-1. Data summary table for flumioxazin residues in/on alfalfa
forage.

![](media/image3.wmf){width="5.4319444444444445in"
height="3.997916666666667in"}

Figure II-2. Data summary table for residues of flumioxazin in/on
alfalfa hay.

![](media/image4.wmf){width="5.6in" height="3.970833333333333in"}