Flumioxazin Summary of Analytical Chemistry and Residue Data DP# : 391781



### 2 o f 40 MRID Summary Table

MRID No. Study Type Comments

48510505 860.1500 and 860.1520 Wheat (Foliar) New DER; 48510505. DER and 48510505. DER2

48510506 860.1500 Wheat (Pre

- plant) New DER; 48510506

. DER



### This document was origin ally prepared under contract by Versar, Inc. (6850 Versar Center, Springfield, VA 22151; submitted 1/2/12). The DER has been reviewed by the Health Effects Division (HED) and revised to reflect current Office of Pesticide Programs (O PP) policies.

Executive Summary

Flumioxazin belongs to the N

- phenylphthalimide class of herbicide s (Group 14) . It is a light

dependent peroxidizing herbicide (LDPH) which acts by blocking heme and chlorophyll biosynthesis

, resulting in an endogenous acc umulation of porphyrins which are known to have a phototoxic mode of action in plants and possibly in fish. Flumioxazin is currently registered for

pre

- and post

- emergence applications on a variety of fruit, vegetable, and field crops for the

control of s usceptible weeds

.

Valent U.S.A Corporation is seeking the registration of flumioxazin on field pea, flax, lentils, sunflower, safflower, and wheat . The end

- use product s (E U P s ) relevant to this registration
request are ValorTM Herbicide (EPA Reg. No. 59639

- 99) and Chateau TM Herbicide (EPA Reg.

No. 59639

- 119) . Both products are water

- dispersible granular (W G) formulation s containing

51% flumioxazin

. The 51% WG formulations are proposed for preplant/preemergence /post

plant ing applications to field pea and wheat at 0.0 64 lb ai/A

. In addition, harves t aid foliar use is proposed on wheat at 0.096 lb ai/A with a 10

- day preharvest interval (PHI) and on field pea, flax, lentil, sunflower, and safflower, at 0.096 lb ai/A , with a 5

- day PHI

.

Concurrently, Valent is request ing the establishment of permanent tolerances for residues of the

herbicide flumioxazin , 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

, in/on the following commodities:

Dried shelled pea and bean (except soybean), Crop Subgroup 6C, seed

..... 0.1 ppm Rapeseed, Crop Subgroup 20A, seed

................................ ........................... 0.35 ppm Rapeseed Crop Subgroup 20A, meal

................................ ........................... 0.04 ppm Rapeseed Crop Subgroup 20A, refined oil

................................ .................. 0.02 ppm Sunflower, Crop Su bgroup 20B, seed

................................ .......................... 0.5 ppm Sunflower, Crop Subgroup 20B, meal

................................ ......................... 0.03 ppm Sunflower, Crop Subgroup 20B, refined oil

................................ ................ 0.02 ppm Wheat, forage

................................ ................................ ............................... 0.02 ppm Wheat, hay

................................ ................................ ................................ ... 0.02 ppm Wheat, grain

................................ ................................ ................................ . 0.35 ppm Wheat, straw

................................ ................................ ................................ 5 ppm Wheat, aspirated grain fraction

................................ ................................ 110 ppm Wheat, bran

................................ ................................ ................................ .. 0.35 ppm Wheat, flour

................................ ................................ ................................ . 0.0 5 ppm Wheat, germ

................................ ................................ ................................ . 0. 35 ppmFlumioxazin Summary of Analytical Chemistry and Residue Data DP# : 391781



### 3 of 40 Wheat, middlings

................................ ................................ ......................... 0.0 8 ppm Wheat, shorts

................................ ................................ ................................ 0. 11 ppm

Flumioxazin t olerances are established under 40 CFR §180.568. Tolerances for residues in/on plant commodities are listed in 40 CFR §180.568[a] and are ex pressed in terms of residues of flumioxazin, including its metabolites and degradates, to be determined by measuring only

flumioxazin

. Tolerances rang e from 0.02 to 8.0 ppm on a wide variety of fruits, vegetables, and field crops. A tolerance for combined residues of flumioxazin and metabolites 482

- HA and APF

in freshwater fish is established at 1.5 ppm. No livestock tolerances have been established. Based on the submitted data, no tolerances for indirect or inadvertent residues are required for

flumioxa zin

.

The nature of flumioxazin residues in plants and animals is adequately understood b ased on

a cceptable soybean, peanut, corn, sugarcane, grape, hen

, and goat metabolism studies. The nature of the residue in rotational crops is also understood based on studies conducted on carrots, lettuce, and wheat. 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.

An adequate gas chromatography/nitrogen

- phosphorus detection (GC/NPD) method , Valent

Method RM30

- A

- 1, is available for enforcing tolerances f or resid ues of flumioxazin in /on plant commodities. The reported method limits of quantitation and detection (LOQ and LOD) for

flumioxazin in /on plant commodities are 0.02 and 0.01 ppm, respectively. The data collection

method used to analyze samples collected f rom the crop field trial and processing studies was

Method RM

- 30A

- 3, a more r ecent version of the enforcement method that us es GC/NPD or GC

with mass selective detection (GC/MS D ). The validated LOQ (determined as the lowest level of method validation; LLM V ) was 0.02 ppm for flumioxazin in/on all matrices. The method was adequate for data collection based on acceptabl e concurrent method recoveries, and the fortification levels used in concurrent method recovery were adequate to bracket expected

residue lev els (within an order of magnitude for canola seed).

Th e requirements for multiresidue methods testing data for flumioxazin are fulfilled. The available data indicate that flumioxazin could not be recovered through application of the multiresidue protocol s.

HED has previously concluded that there is no reasonable expectation of quantifiable residues of flumioxazin in livestock commodities [40 CFR §180.6(a)(3)] from the uses associated with previous flumioxazin petitions. The uses proposed herein will not result in a significant increase in the dietary burden to ruminants ; therefore, no tolerances are required for ruminant commodities. Likewise, despite an increase in the dietary burden for swine , tolerances are not required for hog commodities.

Adequa te storage stability data are available to support the storage conditions and intervals of samples from the submitted crop field trials and processing stud ies

.Flumioxazin Summary of Analytical Chemistry and Residue Data DP# : 391781



### 4 of 40 Acceptable field trial data on canola, field pea, sunflower, and wheat were submitted reflectin g the proposed use patterns for the 51% WG formulation s ; the submitted field pea data will support the proposed use on lentil . Spray adjuvants, including methylated seed oil s (MSO s ), non

- ionic

surfactant s (NIS s ), and/or crop oil concentrates (COC s ) were u sed in all trials. The maximum per trial average residues of flumioxazin were 0.25 ppm in/on canola, 0.056 ppm in/on dried pea, 0.29 ppm in/on sunflower seed, and 0.31 and 3.71 ppm in/on wheat grain and straw (foliar,

harvest

- aid use pattern); r esidues of flumioxazin were below the LOQ (<0.02 ppm) in/on all samples wheat forage and hay (pre

- plant use pattern). T he available data are sufficient for establishing tolerance s o f 0.4 0 ppm for rapeseed subgroup 20A, 0.5 0 ppm for sunflower subgroup 20B, 0.4 0 ppm for wheat grain, 6.0 ppm for wheat straw, and 0.02 ppm for wheat forage and hay . The submitted dried pea data together with the available dried bean data are sufficient for establishing a tolerance of 0.07 ppm for pea and bean, dried shelled, except soybe an, subgroup 6C

. HED believes difference in proposed and recommended tolerances may be attributed to the petitioner’s used the NAFTA tolerance calculation procedures for determining the tolerance and HED ’ s having used the OECD tolerance calculation proced ures.

T he submitted canola, sunflower, and wheat processing stud ies

, reflecting application at ~5 x the maximum proposed seasonal application rate s are adequate

. The data indicate that residues of

flumioxazin do not concentrate canola oil or meal, sunfl ower oil or meal, or wheat bran, flour, middlings, shorts, or germ. F lumioxazin may concentrate in wheat aspirated grain fractions (AGF), with a processing factor of 308x. T he available data indicate that tolerances are not needed for the regulated commod ities of canola, sunflower

, and wheat; however a tolerance is needed for grain, aspirated fractions at 100 ppm.

The previously submitted confined rotational crop study is adequate for the proposed uses on the requested crops . Based on the results of the confined accumulation study, HED concludes that the existing rotational crop plantback intervals (PBIs) are acceptable, and that field trials and tolerances are not necessary.

There are no Codex, Canadian or Mexican MRLs established for residues of flumi oxazin on commodities associated with this petition.

Regulatory Recommendations and Residue Chemistry Deficiencies

HED has examined the residue chemistry database for flumioxazin

. Pending submission of a

revised Section B and Secti on F and updated certificate ( s ) of analysis or new analytical reference

standard ( s ) as specified below, t here are no residue chemistry issues that would preclude g ranting

conditional registration for the requested use of flumioxazin o n field pea, flax, len tils, sunflower, safflower, and wheat

. The proposed use and the submitted data support the following tolerances for residues of flumioxazin in/on the following commodities:

Pea and bean, dried shelled, except soybean, subgroup 6C

......................... 0. 07 ppm Rapeseed subgro up 20A

................................ ................................ ............... 0.4 0 ppm Sunflower subgroup 20B

................................ ................................ ............. 0. 5 0 ppm Wheat, forage

................................ ................................ ............................... 0.02 ppm Wheat, hay

................................ ................................ ................................ ... 0.02 ppm Wheat, grain

................................ ................................ ................................ . 0.4 0 ppmFlumioxazin Summary of Analytical Chemistry and Residue Data DP# : 391781



### 5 of 40 Wheat, straw

................................ ................................ ................................ 6.0 ppm Grain, aspirated fraction s

................................ ................................ ............... . 10 0 ppm

A human health risk assessment for flumioxazin is forthcoming.

860.1200 Directions for Use

The following label revisions/clarifications are required: The general label instructions regarding feeding/grazing restrictions should be omitted

from the label : Except for alf alfa, field corn, and almond hulls do not graze treated fields

or fe ed treated forage or hay to livestock. EPA OPPTS 860.1000 guideline states that there are only three cases where a label restriction should be allowed: peanut hay, soybean forage, and soybean hay. The stated preplanting interval of “[7] 14 days” for prepl ant weed control in wheat should

be clarified . The submitted data will support a minimum preplanting interval of 7 days.

OPPTS 860.1550 Proposed Tolerances

The petitioner should submit a revised Section F reflecting the recommended tolerances

and comm odity d efinitions presented in Table 12

.

OPPTS 860.1650 Submittal of Analytical Reference Standards

T he standard for flumioxazin has expire d on 4/1/2012 . An updated certificate of analysis or a new analytical reference standard must be provided to the EPA National Pesticide Standards Repository.Flumioxazin Summary of Analytical Chemistry and Residue Data DP# : 391781



### 6 of 40 Background

The nomenclature and physicochemical properties of flumioxazin are presented below in Tables

1 and 2. The chemical names and structures of flumioxazin residues of concern are presented in Appendi x I.

Table 1. Flumioxazin Nomenclature. Compound

Common name Flumioxazin Company experimental name VC

- 1152

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

- dihyd ro

- 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 s (EP s) ValorTM Herbicide (EPA Reg. No 59639

- 99) and ChateauTM Herbicide (EPA Reg. No 59639

- 119) . Both products are WG formulations containing 51%

flumioxazin

.

Table 2. Physicochemical Properties of Flumioxazin.

Parameter Value Reference Melting point/range 202

- 204 °C EPA Fact Sheet for Flumioxazin issued April 12, 2001. 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, pK

a None Octanol/water partition coefficient, Log(K OW ) 2.55 at 20 °C

UV/visible absorption spectrum λ 218 λ 216 λ 216 MRID No. 44295004



### 860.1200 Directions for Use

Valent is proposing new uses of flumioxazin for weed control in field pea and wheat and for use

as a harvest aid on field pea, flax, lentils, sunflower, safflower, and wheat . The formulations being proposed for these uses include two 51% W G formulations (V ALOR ® 

### Herbicide, EPA Reg. No. 59639

- 99 and CHATEAU ® 

### WDG Herbicide, EPA Reg. No. 59639

- 119).

In sup port of the proposed uses, Valent has provided example labels containing the proposed use directions. A summary of the proposed use direction s is presented in Table 3.Flumioxazin Summary of Analytical Chemistry and Residue Data DP# : 391781



### 7 of 40 Table 3. Summary of Proposed Use Pattern of Flumioxazin.

Applic. Timing, Type, and Equip. Formulation

[EPA Reg. No.] Applic.

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

Season Max.

Seasonal Applic.

Rate (lb ai/A) PHI

(days) Use Directions and Limitations 1

Field Pea
Preplant or

preemergence, Broadcast,

G round 51% WG

[59639

- 99

and

59639

- 119 ] 0.0 64 Not

specified (NS) 0.064 NS For w eed c ontrol : Apply prior to planting or within 2 days after planting. For use in ID, MT, OR, and WA only. May be t ank

mix ed with other labeled herbicide s for broad spectrum weed control.

Postemergence, Broadcast,

G rou nd (15

- 30 gal/A) 0.048

- 0.096 NS 0.096 5 As a h arvest a id : Apply when crop is physiologically mature and a minimum of 80% of the pods are yellow to tan in color and 20% are y ellow in color. Use of a spray adjuvant (MSO at 1 qt/A) is required. Tank mixing with glyphosate is

recommended.

Flax

Postemergence, Broadcast,

G round (15

- 30 gal/A) 51% WG

[59639

- 99

and 59639

- 119] 0.048

-

0.096 NS 0.096 5 As a harvest aid : Apply when crop is physiologically mature and at least 75%

of the bolls are brown in color.

Use of a spray adjuvant (MSO at 1 qt/A) is required.

Lentils

Postemergence, Broadcast,

G round (15

- 30 gal/A) 51% WG

[59639

- 99

and 59639

- 119] 0.048

-

0.096 NS 0.096 5 As a harvest aid : Apply when crop is physiologically mature and a minimum of 80% of the pods a re yellow to tan in color and 20% are yellow in color. Use of a spray adjuvant (MSO at 1 qt/A) is required.

Sunflower and Safflower

Postemergence, Broadcast,

G round (15

- 30 gal/A) 51% WG

[59639

- 99

and 59639

- 119] 0.048

-

0.096 NS 0.096 5 As a harvest aid : Apply when crop is

mature (35% moisture or less). Use of a spray adjuvant (MSO at 1 qt/A) is required.

Wheat

Preplant or postplant

, Broadcast,

Ground 51% WDG

[59639

- 99

and 59639

- 119] 0.064 NS 0.064 NS For weed control : Apply at least [7] 14 [ sic. ] day s prior to planting or up to 2 days after planting.

U se only on no

- till or minimum tillage fields where last year’s crop residue has not been incorporated into the soil. Do not graze until wheat has reached 5 inches in height.

Postemergence, Broadcast,

G round ( min. 10 gal/A ) and

aerial (min. 5 gal/A) 0.064 NS 0.064 10 As a harvest aid : Apply when crop reaches the hard dough stage and grain

has no more than 30% moisture. Use of a spray adjuvant (MSO at 1 qt/A) is required. Tank mixing with glyphosate is

recommended.Flumioxazin Summary of Analytical Chemistry and Residue Data DP# : 391781



### 8 of 40 1 The general label instructions state: Except for alfalfa , field corn, and almond hulls do not graze treated fields or feed treated forage or hay to livestock. MSO = Methylated soybean oil.



### Burndown Application ( Preplant to Crop ) : F lum ioxazin may be used in fall and spring burndown program s in AZ, CA, and HI only, in sunflower and wheat at 0.032

- 0.064 lb ai/A

. Applications must be made at least 30 days prior to planting

. Flumioxazin may also be used in fall burndown programs in AZ, CA , and HI only in fields to be planted to field pea, flax, lentil, safflower, sunflower, and spring wheat at 0.064

- 0.128 lb ai/A

. Applications are to be made at

recomme n ded rotational intervals prior to planting. Use of a spray adjuvant (COC, MSO, or NIS at 0.25% v/v) is required for all burndown applications

. Applications are to be made in spray

volumes of 15

- 60 gal/A

.

Rotational crop restriction s : C urrent label directions for both 51% WG formulations include the following statement: Do not plant any c rop except cotton, peanut, soybean and sugarcane earlier than 30 days after application of flumioxazin. In addition, the labels 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 12

- 18 months for all other crops not listed

.

Conclusions

. The use directions are adequate to allow evaluation o f the field trial data for

canola

, field pea, sunflower, and wheat relative to the proposed use s

. Although no use directions

were submitted for canola , and flax are members o f rapeseed subgroup 20A ; therefore, the use directions for flax are adequate to a llow evaluation of the field trial data for canola

. The submitted field trial data for field pea will support use on lentil.

The submitted canola, dried pea, sunflower, and wheat crop field trials were conducted according to the maximum proposed use pa ttern and reflected the use of an MSO, NIS, and /or COC spray adjuvant s either in side

- by

- side plots or in separate trials

. In general, there were no major differences between applications made with an MSO and those made with an NIS or COC , and no single adjuvant yielded consistently higher residues in any crop

. HED believes the submitted data are sufficient to support use of the 51% WG formulations with an MSO

, NIS

, or COC adjuvant.

In consideration of the proposed uses and submitted data, t he follow ing label

revisions/c l arifications are required: The general label instructions regarding feeding/grazing restrictions should be omitted

from the label : Except for alfalfa, field corn, and almond hulls do not graze treated fields or feed treated forage or hay to livestock

. EPA OPPTS 860.1000 guideline states that there are only three cases where a label restriction should be allowed: peanut hay, soybean forage, and soybean hay. The stated preplanting interval of “[7] 14 days” for preplant weed control in wheat should

be clarified . The submitted data will support a minimum preplanting interval of 7 days.Flumioxazin Summary of Analytical Chemistry and Residue Data DP# : 391781



### 9 of 40 860

. 1300 Nature of the Residue

– Plants.

Residue Chemistry Memo DP# 301247, 7/23/04, W. Drew

MARC Decision Memo D P# 272652, 3/ 12 /01, R. Loranger

Residu e Chemistry Memo D P# 259493 , 3/ 12/01, D. Dotson



### Adequate plant metabolism studies are available depicting the uptake and metabolism of
[ 14 

### C]flumioxazin following applications to soybean (preemergence) , peanut (preemergence) , corn ( preemergence) , sugarcane (directed to the lower 3 feet of plants) , and grape s (directed to soil surface surrounding vines)

. Based on these studies, HED determined that the parent compound only is the residue of concern to be used in risk assessments and t he tolerance expression for primary and rotated crops. The available data are adequate to support the uses proposed herein.

860.1300 Nature of the Residue

– Livestock.

MARC Decision Memo D P # 272652

, 3/ 12/01

, R. Loranger Residue Chemistry Memo DP# 259 493, 3/12/01, D. Dotson Residue Chemistry Memo DP # 194594, 9/ 21 /94, J. Garbus



### Adequate ruminant and poultry metabolism studies are available depicting the metabolism of flumioxazin radiolabeled in either the phenyl or tetrahydrophthaloyl (THP) ring. Th e 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. HED has 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.

Residue Chemistry Memo DP# 259493, 3/12/01, D. Dotson Residue Chemistry Memo DP# 342963, 11/20/07, D. Rate Residue Chemistry Memo No DP#

, 1/8/96

, J. Garbus



### Plant commodities

Enforcement method: An ade quate GC/NPD method is available for enforcing tolerances f or residues of flumioxazin in /on plant commodities (MRID 43935509, Valent Residue Method

#RM

- 30A

- 1, Determination of Flumioxazin Residues in Crops ; No DP#, 1/8/96, J. Garbus).

This method has unde rgone 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.

Data collection method : Samples of canola, dried pea, sunflower, and wheat raw agricultural and processed commodities from the submitted crop field trial and processing studies were analyzed

for residues of flumioxazin using a GC/NPD /MSD method entitled “Determination ofFlumioxazin Summary of Analytical Chemistry and Residue Data DP# : 391781



### 10 of 40 Flumioxazin Residues in Crops: Residue Method RM

- 30A

- 3 .” This method is a more recent

version of Method RM

- 30A

- 1.

Briefly, residues w ere extracted with acetone : water (4:1, v:v) and then partitioned into dichloromethane ( DCM ) . After evaporation of the DCM, residues were purified by partitioning

between hexane/ acetonitrile (ACN) . The residues in the ACN phase were 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 or GC/MS D , using an external standard.

T he methods were adequately validated in conjunction with the analysis of samples from the

field trial and processing studies. The fortification levels used in concurrent method recovery were adequate to bracket expected residue levels (within an order of magnitude for canola seed). The validated method LOQ (determined as the LLMV) for flumioxazin was 0.02 ppm, and the

LOD was 0.01 ppm , for all matrices

.

Livestock commodities

A dequate data collection methods were submitted in conjunction with the cattl e feeding study ( DP # 342963) . 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. The 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 0.1 ppm. For both methods, the validated LOQ is 0.02 ppm for each analyte , and the reported LOD is 0.01 ppm.

Conclusions. The available and submitted residue analytical methods data for plant

commodities are adequate to satisfy data requirements for this petition. Adequate methods are available for tolerance enforcement p urposes for the residues of concern in plant commoditie s, and s amples of canola, dried pea, sunflower, and wheat commodities from the submitted crop field trial and processing studies were analyzed for residues of flumioxazin using adequate data

collection methods.

No additional residue analytical methods data for livestock commodities are required at this time.

860.1360 Multiresidue Methods

Residue Chemistry Memo DP # 259493, 12 / MAR / 20 01

, D. Dotson Residue Chemistry Memo DP # 397086

, 22 / FEB / 20 1 2, W

. T. D rew



### Data depicting the analysis of flumioxazin and degradates 482

- HA and APF through FDA Multiresidue Protocols were submitted to FDA for review. The multiresidue method testing data indicate that flumioxazin is not recovered throug h Sections 304 and 402 of PAM, Vol. I. Additionally, the PAM extraction method for fatty commodities (304 E1) does not work for 482

- FIA or APF

.Flumioxazin Summary of Analytical Chemistry and Residue Data DP# : 391781



### 11 of 40 860.1380 Storage Stability

Residue Chemistry Memo DP# 342413, 1/31/08, D. Rate Residue Chemistry Memo DP# 34 2963, 11/20/07, D. Rate Residue Chemistry Memo DP#310408, 3/15/06, W. Drew Residue Chemistry Memo DP# 301247, 7/23/04, W. Drew Residue Chemistry Memo DP# 298647, 2/17/04, W. Drew Residue Chemistry Memo DP# 259493, 3/12/01, D. Dotson Residue Chemistry M emo DP# 194594, 5/21/94, J. Garbus



### Storage stability data for flumioxazin residues in various plant commodities are available from several earlier petitions. These data indicate that flumioxazin is reasonably stable under frozen
storage (

- 20 oC) 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

- 11 months in mint tops and oil; 9 months in prunes, wet apple pomace, potatoes, and pot ato 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; 2 to 3 months in grape juice, and sugar cane molasses and refined sugar; 30 months in alfalfa forage and hay; 22 months in dry beans; 7 months in tomatoes and asparagus; 5.8 months in blueberries; 4 months in cantaloupes and pecans; 6 months in corn forage ; and 13.3 months in corn grain and

stover.

For the wheat processing st udy, HED has concluded that, in consideration of the nature of the processing procedures for wheat commodities (i.e., fractions are not heated or chemically treated during processing and are generally physically similar to whole grain), and the large amoun t of storage stability data available indicating that residues of flumioxazin are stable in/on a wide variety of raw agricultural and processed commodities, the available representative storage stability data may be translated to the processed wheat commod ities for purposes of this petition.

Sample storage intervals and conditions

Samples collected from the field trial and processing studies were stored frozen prior to residue analysis. S torage durations and conditions of samples are presented in Table 4

.

T able 4

. Summary of Storage Conditions and Intervals of Samples from Field Corn Field Trials.

Matrix Storage

Temperature (°C) Actual Storage Duration (days) 1 Interval of Demonstrated Storage Stability (days)

Crop Field Trial Studies

Canola see d

- 20 134

- 417 days (4.4

- 13.7 months) 12 months in/on soybean seed 2
684 days (22.5 months) in/on dry bean seed 3

Dried pea 61

- 134 days (2.0

- 4.4 months) 684 days (22.5 months) in/on dry bean seed 3

Sunflower seed 277

- 342 days (9.1

- 11.3 months) 12 month s in/on soybean seed 2

Wheat grain 329

- 501 days (10.8

- 16.5 months) 404 days (13.3 months) in/on corn grain 4
684 days (22.5 months) in/on dry bean seed 3

Wheat straw 374

- 515 days (12.3

- 16.9 months) 404 days (13.3 months) in/on corn stover 4
929 days (3 0.6 months) in/on alfalfa hay

. 3

Wheat forage 6

- 28 days (0.2

- 0.9 months) 417 days (13.7 months) in/on corn forage 4

Wheat hay 39

- 74 days (1.3

- 2.4 months) 929 days (30.6 months) in/on alfalfa hay 3Flumioxazin Summary of Analytical Chemistry and Residue Data DP# : 391781



### 12 of 40 T able 4

. Summary of Storage Conditions and Intervals of Samples from Field Corn Field Trials.

Matrix Storage

Temperature (°C) Actual Storage Duration (days) 1 Interval of Demonstrated Storage Stability (days)

Processing Studies

Canola seed ( RAC) - 20 273 days (9.0 months) 12 months in/on soybean seed 2

Canola Oil 170 days (5.6 months) 267 days (8.8 months) in mint oil 5

Canola Meal 175 days (5.8 months) 93 days (3.1 months) in cotton meal 6 ; 300 days (10 months) in peanut nutmeats 7 ; 186 days (6 months) in alm ond nutmeats 5

Sunflower seed (RAC) 320

- 323 days (10.5

- 10.6 months) 12 months in/on soybean seed 2

Sunflower Oil 228 days (7.5 months) 267 days (8.8 months) in mint oil 5

Sunflower Meal 230

- 238 days (7.6

- 7.8 months) 93 days (3.1 months) in cotton meal 6 ; 300 days (10 months) in peanut nutmeats 7 ; 186 days (6 months) in almond nutmeats 5

Wheat grain (RAC) 436 days (14.3 months) 404 days (13.3 months) in/on corn grain 4
684 days (22.5 months) in/on dry bean seed 3

Bran 269 days (8.8 months) T he avail able storage stability data

summarized above for a wide variety of raw agricultural and processed commodities may be translated to the processed wheat

commodities. Flour 287 days (9.4 months)

Middlings 280 days (9.2 months)

Shorts 280 days (9.2 mo nths)

Germ 336 days (11.1 months)

AGF 370 days (12.2 months)

1 Interval from harvest or processing to analysis. Samples were analyzed within 1

- 32 days of extraction. Processing was completed within 85

- 115 days of harvest. At three canola trials, canola was swath cut and allowed to dry in the field for 6

- 16 days prior to collection.

2 DP# 194594, 5/21/94, J. Garbus (soybean seed)

3 DP# 3429 63, 11/ 2 0/ 0 7, D. Rate (dry bean, alfalfa hay)

4 DP# 342413, 1/31/08, D. Rate (corn gr ain, stover, and forage)

5 DP# 301247, 7/23/04, W. Drew (mint oil, almond nutmeats)

6 DP# 298647, 2/17/04, W. Drew (cotton meal)

7 DP# 259493, 3/12/01, D. Dotson (peanut nutmeats)



### Conclusions

. The available storage stability data are adequate and supp ort the sample storage

durations for in canola seed

, dried pea, sunflower seed , and wheat forage, hay, grain, and straw samples and canola

, sunflower , and wheat process ed fraction samples

. The data indicate that there are no storage stability issues, and n o corrections for decline on storage are needed for these

matrices

.

860.1400 Water, Fish, and Irrigated Crops

There are no proposed uses in the current petition that are relevant to this guideline topic.

860.1460 Food Handling

There are no proposed u ses in the current petition that are relevant to this guideline topic.

860.1480 Meat, Milk, Poultry, and EggsFlumioxazin Summary of Analytical Chemistry and Residue Data DP# : 391781



### 13 of 40 DP# 342963, 11/20/ 07, D. Rate (Feeding study; alfalfa residues)

DP# 342413, 1/31/08, D. Rate (Dietary burden calculation)

DP#s 259493 and 268181 , 3/12/01, D. Rate (Poultry metabolism study)



### The following livestock feedstuffs are associated with the proposed uses in this petition: field pea vines/silage and hay; flax meal; sunflower and safflower meal; wheat forage, hay, grain, and

straw ; and asp irated grain fractions.

T he theoretical dietary burdens of flumioxazin were most recently calculated under PP#7E7243

, reflecting use on field corn (DP# 342413) . The calculated dietary burdens were 0.96 ppm for beef cattle, 3.19 ppm for dairy cattle, an d 0.02 ppm for both poultry and swine

. The dietary burdens were evaluated in conjunction with the cattle feeding study and the poultry metabolism study , and the Agency concluded that the proposed use would not alter HED’s previous

determination that a 40 CFR §180.6[a][3] situation exist ed for livestock commodities (DP# 342963)

.

The addition of uses on sunflower, safflower, and wheat, will have a n impact on the dietary

burdens to ruminants, poultry, and swine

.

The maximum reasonable dietary burden (MR DB) calculations reflecting the addition of the

feedstuffs listed above are presented in Table 5. The current MRDBs of flumioxazin are estimated at 2.23 7 and 1.25 2 ppm for beef and dairy cattle, 0.168 ppm for poultry, and 0.142 ppm for swine.

Table 5. Ca lculation of Dietary Burdens of Flumioxazin Residues to Livestock.

Feedstuff Type 1 % Dry

Matter 2 % Diet 2 Expected Residue Dietary

Contribution (ppm) 3 ppm Value used

Beef Cattle [80% CC, 5% PC, 15% R]

Alfalfa, hay R 89 5 1.60 HAFT 0.090

Wheat, st raw R 88 10 3.71 HAFT 0.422

Corn, field, grain CC 88 5 0.02 Median 0.001

Wheat, aspirated grain

fractions CC 85 5 27.72 Median x PF 1.631

Sugarcane, molasses CC 75 10 0.20 Tolerance 0.027

Wheat, grain CC 89 20 0. 09 Median 0.0 2 0

Wheat, milled byproduct s CC 88 40 0. 09 Median 0.0 41

Sunflower, meal PC 92 5 0. 1 0 Median 0.00 5

TOTAL BURDEN

-- -- 100

-- -- 2.2 37

Dairy Cattle [45% CC, 10% PC, 45% R]

Alfalfa, h ay (meal) R 89 20 1.60 HAFT 0.360

Alfalfa

, silage (forage) R 40 20 0. 91 HAFT 0.4 57

Wheat, straw R 88 5 3.71 HAFT 0.211

Wheat, grain CC 89 15 0. 09 Median 0.01 5

Wheat, milled byproducts CC 88 30 0. 09 Median 0.03 1

Alfalfa, meal PC 90 10 1.60 HAFT 0.1 78

TOTAL BURDEN

-- -- 100

-- -- 1. 2 52Flumioxazin Summary of Analytical Chemistry and Residue Data DP# : 391781



### 14 of 40 Table 5. Ca lculation of Dietary Burdens of Flumioxazin Residues to Livestock.

Feedstuff Type 1 % Dry

Matter 2 % Diet 2 Expected Residue Dietary

Contribution (ppm) 3 ppm Value used

Poultry [75% CC, 25% PC]

Wheat, grain CC 89 75 0. 09 Median 0.0 68

Alfalfa, meal PC 89 5 1.60 HAFT 0.080

Sunflower, meal PC 92 2 0 0.10 Median 0.0 2

TOTAL BURDEN

-- -- 100

-- -- 0. 168

Swine [85% CC, 15% PC]

Corn, field, grain CC 85 35 0.02 Median 0.007

Wheat, milled byproducts CC 88 50 0.09 Median 0.0 4 5

Alfalfa, m eal PC 89 5 1.60 HAFT 0.080

Sunflower, meal PC 92 10 0.10 Median 0.01 0

TOTAL BURDEN

-- -- 100

-- -- 0.1 42

1 R: Roughage; CC: Carbohydrate concentrate ; PC: Protein concentrates

. 2 OPPTS 860.1000 Table 1 Feedstuffs (June 2008).

3 Contribution = ([tol erance /% DM] X % diet) for beef and dairy cattle; contribution = ([tolerance] X % diet) for poultry and swine.



### Cattle Acceptable cattle feeding study with flumioxazin was previously reviewed (DP# 342963). Three groups of dairy cattle (3 cows per group) were dosed orally with capsules containing flumioxazin at levels equivalent to 2, 6 and 20 ppm in the diet for 28 consecutive days. Only samples from

the 20

- ppm dose group were analyzed; this dosing level corresponds to 8.9 x the current MRDB

for beef cat tle of 2.236 ppm

. In the 20

- ppm dose group, residues of flumioxazin and its

metabolites 3

- OH

- flumioxazin and 4

- OH

- flumioxazin were each non

- detectable (<0.01 ppm; combined residues <0.03 ppm) in all samples of milk, skim milk, cream, liver, kidneys, muscl e, and fat from all three cows.

The current MRDBs for beef and dairy cattle of 2.23 7 and 1.25 2 ppm are comparable to those previously calculated reflecting use on field corn (DP# 342413) . We note that changes in the residue values that HED uses to gene rate the dietary burden (i.e., use of HAFT residues for most feedstuffs, median residues for blended feeds, and median residues x processing factor for AGF, instead of tolerances) resulted in an MRDB for ruminants that is slightly lower than that previousl y calculated despite an increase in uses on significant livestock feedstuffs and the addition of foliar use on wheat. Based on the available cattle feeding study, HED concludes that

a 40 CFR §180.6[a][3] situation still exists for ruminant commodities.

Swine For swine, the 20

- ppm dosing level used in the cattle feeding study corresponds to 141 x the current MRDB. Conversion of the expected residues of flumioxazin, 3

- OH

- flumioxazin, and 4

- OH

- flumioxazin in ruminant tissues (<0.03 ppm) to a 10x feeding l evel, results in expected

residues of 0.00 2 ppm, well below the method LOQ.

Poultry A poultry feeding study has not been submitted for flumioxazin. In the poultry metabolism study (DP#s 259493 and 268181 , 3/12/2001 ) , hens were dosed for 14 days at 9.0 1 ppm. This dose rateFlumioxazin Summary of Analytical Chemistry and Residue Data DP# : 391781



### 15 of 40 corresponds to ~ 54 x the current MRDB of 0.142 . HED previously concluded that the residues of concern in poultry commodities are flumioxazin, 3

- OH

- flumioxazin, 4

- OH

- flumioxazin, and 4

- OH

- S

- 53482

- SA.

Presuming a method LOQ of 0.02 p pm for each analyte in poultry matrices (combined LOQ of 0.08 ppm) , if the maximum combined residues of flumioxazin, 3

- OH

- flumioxazin, 4

- OH

flumioxazin, and 4

- OH

- S

- 53482

- SA in egg yolk and liver from the metabolism study are converted to a 10x dosing level , expected residues in egg yolk are still below the LOQ (see Table 6). HED believes that based on the calculated expected residue levels, a poultry feeding study is

not warranted at this time.

Table 6. Summary of Residues of Concern Identified in Eggs an d Tissues from Laying Hens Dosed

with THP

- [ 14 C]Flumioxazin at a Feeding Level Equivalent to 9.01 ppm in the Diet for 14 Consecutive Days.

Residue Component Egg yolk, Day 13 (TRR = 0.630 ppm) Liver (TRR = 1.137 pm)

Flumioxazin 0.053 0.079

3

- OH

- Flumioxazi n 0.025 0.079

4

- OH

- Flumioxazin 0.037 0.121

4

- OH

- S

- 53482

- SA 0.299 0.068

Combined Residues 0.414 0.347

Expected Residues at 1x Dosing level 0.008 1 0.006

Expected Residues at 10x Dosing Level 0.077 0. 065

1 Based on combined residues (0.414)/poultry feed ing level (9.01) * dietary burden (0.168)



### Conclusions. The available ruminant feeding study is acceptable to support the proposed new uses of flumioxazin on field pea, flax, sunflower and safflower, and wheat. Based on the current dietary burden to rum inants , HED concludes that tolerances are not required for ruminant

commodities.

The available ruminant feeding study and the current MRDB for swine and poultry indicate that tolerances are not required (40 CFR §180.6[a][3]) despite the increase in MRDB

.

860.1500 Crop Field Trials

DER References: 48510501. DER1 ( C anola )

48510502

. DER ( Dried pe a, includes review of MRID 48510503 )

48510504. DER1 ( S unflower )

48510505. DER1 ( W heat; foliar application )

48510506

. DER ( W heat; pre

- plant application )

Resi due Chemistry Memo DP# 342963, D. Rate 11/20/07 ( Dried bean)



### Canola

Valent U.S.A. Corporation has submitted field trial data for flumioxazin on canola

. Eight field trials were conducted in the United States during the 2009 growing season in the North Am erican Free Trade Agreement (NAFTA) Growing Zones 2 (GA; 1 trial), 5 (MN; 1 trial), 7 (ND and MT;Flumioxazin Summary of Analytical Chemistry and Residue Data DP# : 391781



### 16 of 40 3 trials), and 11 (ID and WA; 3 trials).

Each trial consisted of one untreated plot and one or two treated plots. At each trial location, one treated plot received one foliar application of a 51% WG formulation of flumioxazin ( Valor SX 51 WDG) at 0.092

- 0.101 lb ai/A (~1x the maximum proposed seasonal application rate) . At two trial sites (Norwich, ND, and Payette, ID), a second plot was treated at a 2x rat e of 0.190

- 0.194 lb ai/A to evaluate the effect of application rate on residue levels. Applications were made using ground equipment in spray volumes of 15.1

- 21.5 gal/A. Adjuvants were added to each spray mixture, with five trials using a n MSO and three trials using an MSO and a n NIS in side

- by

- side treated plots. Samples of canola seed were harvested at maturity from all trials at a PHI of 4

- 5 days. At one trial (Campbell, MN)

, additional samples were collected at PHIs of 1

, 3

, 5 , and 8 days to assess residue decline. In three trials, the canola was swath cut and allowed to dry in the

field for 6

- 16 days prior to collection.

Samples were analyzed for residues of flumioxazin using a n acceptable GC/NPD or GC/MS method, Valent method RM

- 30A

- 3

. The study is supported by adequate storage stability data.

The results of the canola field trials are presented in Table 7

. In samples of canola seed

harvested 4

- 5 days following a single foliar application of the 51% WG formulation of

flumioxazin at 0.092

- 0.10 1 lb ai/ A with an NIS or MSO adjuvant

, residues of flumioxazin (and per trial averages) were: 0. 04

- 0.30 ( 0. 04

- 0.25) ppm in/on canola seed following applications made with an MSO; and 0. 02

- 0.12 ( 0. 03

- 0.07) ppm in/on canola seed following applications

made with an NIS. Overall residues (and per trial averages) for applications made with either adjuvant were 0.02

- 0.30 (0.0 3

- 0.25) ppm. Side

- by

- side comparison of residues following applications with NIS and MSO adjuvants suggested that residues in seed were s lightly higher following applications made with an MSO.

Following application of flumioxazin at a 2x rate of 0.190

- 0.194 lb ai/A with an MSO adjuvant

, residues of flumioxazin (and per trial averages) in/on canola seed were 0. 09

- 0.16 ( 0. 10

- 0.16)

ppm. T here was a proportional increase in residues due to the application rate.

In the residue decline trial, residues of flumioxazin in/on canola seed remained constant at the 1

- , 3

- , and 5

- day PHIs (average of 0.16 ppm each), and decreased at the 8

- day PHI (a verage of 0.04 ppm). The petitioner indicated that a rain event (0.59”) which occurred between the Day

- 5 and Day

- 8 samplings may have accounted for the decline in residues.

Table 7 . Summary of Residue Data from Canola Field Trials with Flumioxazin.

C ommodity Adjuvant Total

Rate (lb ai/A) PHI

(days) Residue Levels (ppm) 1

n Sample

Min. Sample

Max. LAFT 2 HAFT 2 Median Mean Std.

Dev.

FLAX (proposed use = 0.096 lb ai/A total application rate, 5

- day PHI)

1x Rate

Canola seed NIS 0.092

- 0.098 4

- 5 3 0.02 0.12 0.03 0.07 0.04 0.05 0.02

MSO 0.094

- 0.101 4

- 5 8 0.04 0.30 0.04 0.25 0.06 0.09 0.08

NIS/MSO 0.092

- 0.101 4

- 5 11 0.02 0.30 0.03 0.25 0.05 0.08 0.07

2x RateFlumioxazin Summary of Analytical Chemistry and Residue Data DP# : 391781



### 17 of 40 Table 7 . Summary of Residue Data from Canola Field Trials with Flumioxazin.

C ommodity Adjuvant Total

Rate (lb ai/A) PHI

(days) Residue Levels (ppm) 1

n Sample

Min. Sample

Max. LAFT 2 HAFT 2 Median Mean Std.

Dev.

Canola seed MSO 0.190

- 0.194 4

- 5 2 0.09 0.16 0.10 0.16 0.13 0.13 0.04

1 Except for sample m in/max, values reflect per trial averages; n = no. of field trials ; for the combined results for NIS and MSO,

side

- by

- side trials were counted as separate trials.

2 LAFT = lowest average field trial; HAFT = highest average field trial.



### Conclusions. The s ubmitted canola crop field trial data are acceptable. T he maximum use pattern for canola has not been provided; however, the study reflects the maximum proposed harvest aid use pattern for flax , a member of rapeseed subgroup 20A . T he number and locations

of the field trials are i n accordance with OCSPP 860.1500. An acceptable method was used for residue quantitation, and the data are supported by adequate storage stability data.

T he submitted data for canola are sufficient fo r establishing tolerances of 0. 4 0 ppm associated with the requested registration of the 51% WG formulation s on flax

. The tolerance calculations are presented in Appendix I I

.

Dried Pea

Valent U.S.A. Corporation has submitted field trial data for flumioxazin on dried pea

. Thirteen

field trials were conducted in Canada and the United States during the 2009 growing season in

the NAFTA Growing Zones 5 (ND; 2 trials), 7 (ND; 2 trials), 11 (OR and ID; 2 trials) and 14 (MB and SK; 7 trials).

Each trial consisted of one untreated plot and one or two treated plots. At each trial location, one treated plot received one fo liar application of a 51% WG formulation of flumioxazin ( Valor SX 51 WDG) at 0.093

- 0.100 lb ai/A (104.9

- 112.0 g ai/ha) (~1x the maximum proposed seasonal application rate)

. At two trial sites (Norwich, ND, and Payette, ID), a second plot was treated at

a 2x rate of 0. 193 lb ai/A (216.0

- 216.5 g ai/ha) to evaluate the effect of application rate on residue levels. Applications were made using ground equipment in spray volumes of 15.0

- 21.5 gal/A (140.3

- 201.0 L/ha). Adjuvants were added to each spray mixture, with seven trials using

a n MSO, three trials using a COC, one trial using a n NIS, and two trials using both MSO and

NIS in side

- by

- side treated plots. Samples of dried pe a were harvested at maturity from all trials at a preharvest interval (PHI) of 4

- 6 days. At one trial (in ND), additional samples were collected at PHIs of 1, 3, 5, and 7 days to assess residue decline.

Samples were analyzed for residues of flumioxazin using a n acceptable GC/NPD method, Valent

method RM

- 30A

- 3

. The study is supported by adequate storage stability data.

The results of the dried pea field trials are presented in Table 8

. In samples of dried pea

harvested 4

- 6 days following a single fo liar application of the 51% WG formulation of

flumioxazin at 0.093

- 0.100 lb ai/A (104.9

- 112.0 g ai/ha) with a COC, NIS or MSO adjuvant, residues of flumioxazin (and per trial averages) were: <0.02

- 0.033 (<0.02

- <0.027) ppm in/on dried pea following applica tions made with a COC; <0.02

- 0.037 (<0.02

- 0.030) ppm in/on dried pea following applications made with an NIS; and <0.02

- 0.065 (<0.02

- 0.056) ppm in/on dried pea following applications made with an MSO. Overall residues (and per trial averages) forFlumioxazin Summary of Analytical Chemistry and Residue Data DP# : 391781



### 18 of 40 applicat ions made with any adjuvant were <0.02

- 0.065 (0.02

- 0.056) ppm. We note that the highest residues were observed in the Payette, ID trial (V

- 32857

- F; MSO adjuvant), in which the petitioner reported that peas had been harvested after normal harvest and were drier than normal (7% moisture content). No differences were observed in s ide

- by

- side comparison of residues following applications made with NIS and MSO adjuvants.

Following application of flumioxazin at a 2x rate of 0.193 lb ai/A (216.0

- 216.5 g ai/ha ) with an MSO adjuvant, residues of flumioxazin (and per trial averages) in/on dried pea were <0.02

- 0.092 (<0.02

- 0.079) ppm. The trials showed no effect on residues due to application rate.

In the residue decline trial, results for flumioxazin in dried p ea were inconclusive because residues were near or below the LOQ at all harvest intervals.

Table 8 . Summa ry of Residue Data from Dried P ea Field Trials with Flumioxazin.

Commodity Adjuvant Total

Rate

lb ai/A (g ai/ha) PHI

(days) Residue Levels (ppm) 1

n Sample

Min. Sample

Max. LAFT 2 HAFT 2 Median Mean Std.

Dev.

FIELD PEA (proposed use = 0.096 lb ai/A total application rate, 5

- day PHI)

1x Rate
Dried pea

seed COC 0.096

- 0.098 (107.6

- 110.5) 6 3 <0.02 0.033 0.02 0.027 0.020 0.022 0.004

NIS 0.096

- 0. 100

(107.3

- 112.0) 4

- 5 3 <0.02 0.037 0.02 0.030 0.021 0.024 0.006

MSO 0.093

- 0.098

(104.9

- 110.5) 4

- 6 9 <0.02 0.065 0.02 0.056 0.020 0.024 0.012

COC/NIS/MSO 0.093

- 0.100

(104.9

- 112.0) 4

- 6 15 <0.02 0.065 0.02 0.056 0.020 0.024 0.009

2x Rate

Dried pea

seed MSO 0.193 (216.0

- 216.5) 4

- 5 2 <0.02 0.092 0.02 0.079 0.050 0.050 0.042

1 Except for sample min/max, values reflect per trial averages; n = no. of field trials ; for the combined results for COC, NIS and MSO, side

- by

- side trials were counted as separate t rials.

2 LAFT = lowest average field trial; HAFT = highest average field trial.



### Conclusions. The submitted dried pea crop field trial data are acceptable

. The studies reflect the maximum proposed use pattern for field pea , and the number and locations of the field trials are

in accordance with OCSPP 860.1500. An acceptable method was used for residue quantitation, and the data are supported by adequate storage stability data. The submitted data will support

use on lentil. The submitted data for dried pea are sufficient for establishing a tolerance of 0.07 ppm associated with the requested registration of the 51% WG formulations on dried pea seed

. The tolerance calculations are presented in Appendix I I

.

Dr ied Bean

The Interregional Research Project No. 4 (IR

- 4) previously submitted acceptable field trial data

for flumioxazin on dried beans (DP# 342963 ) reflecting application of a 51% WG formulation of

f lumioxazin to dried bean varieties as a single preharvest, broadcast a pplication at 0.091

- 0.096 lbFlumioxazin Summary of Analytical Chemistry and Residue Data DP# : 391781



### 19 of 40 ai/A , with a COC added to the spray mixture

. Beans were harvested at a 4

- to 6

- day PHI, and dried prior to shelling.

Following a single preharvest broadcast application of flumioxazin at 0.091

- 0.096 lb ai/A,

residues were ND

- 0.05 ppm in/on 26 samples o f dried beans harvested at a 4

- to 6

- day PHI ;

r esidues were <LOQ (<0.02 ppm) in/on 22 of the se 26 samples. Based on the submitted data, a tolerance was established for bean, dry seed at 0.05 ppm.

Sunflower

Valent U.S.A. Corporation has submitted field t rial data for flumioxazin on sunflower

. Eight field trials were conducted in the United States during the 2009 growing season in the NAFTA Growing Zones 5 (KS, MN, and ND; 3 trials), 7 (MT, ND, and NE; 4 trials), and 8 (OK; 1 trial).

Each trial consisted of one untreated plot and one or two treated plots. At each trial location, one treated plot received one foliar application of a 51% WG formulation of flumioxazin ( Valor SX 51 WDG) at 0.094

- 0.099 lb ai/A (~1x the maximum proposed seasonal application ra te) . At two trial sites (Stafford, KS and Norwich, ND), a second plot was treated at a 2x rate of 0.193

- 0.195 lb ai/A to evaluate the effect of application rate on residue levels. Applications were made using ground equipment in spray volumes of 15.4

- 22. 1 gal/A. Adjuvants were added to each spray mixture, with four tria ls using a n MSO , one trial using a n NIS, and three trials using both in side

by

- side treated plots. Samples of sunflower seed were harvested at maturity from all trials at a

PHI of 4

- 5 da ys. At one trial (in MN)

, additional samples were collected at PHIs of 1

, 3

, 5 , and 7 days to assess residue decline. In one trial (NE), the sunflower heads were collected and dried indoors for 1 day prior to collection.

Samples were analyzed for residu es of flumioxazin using a n acceptable GC/NPD or GC/MS method, Valent method RM

- 30A

- 3

. The study is supported by adequate storage stability data.

The results of the sunflower field trials are presented in Table 9

. In samples of sunflower seed

harvested 4

- 5 days following a single foliar application of the 51% WG formulation of

flumioxazin at 0.094

- 0.099 lb ai/ A with an NIS or MSO adjuvant

, residues of flumioxazin (and per trial averages) were: 0. 03

- 0.34 ( 0. 03

- 0.29) ppm in/on sunflower seed following app lications made with an MSO; and 0. 03

- 0.18 ( 0. 04

- 0.18) ppm in/on sunflower seed following applications

made with an NIS. Overall residues (and per trial averages) for applications made with either adjuvant were 0.0 3

- 0. 34 (0.0 3

- 0.2 9 ) ppm. In the s ide

- by

- si de trials with NIS and MSO, residues were much higher following application with NIS in one set of trials (average residues of 0.18 ppm for the NIS vs. 0.06 ppm for the MSO); however, differences in the other two trials were slight, and a consistent patter n of higher residues was not observed for either adjuvant.

Following application of flumioxazin at a 2x rate of 0.193

- 0.195 lb ai/A with an MSO adjuvant

, residues of flumioxazin (and per trial averages) in/on sunflower seed were 0. 14

- 0.20 ( 0. 14

- 0.17)

ppm

. There was not a proportional increase in residues due to the application rate.

In the residue decline trial, residues of flumioxazin in sunflower seed generally decreased with increasing PHIs

.Flumioxazin Summary of Analytical Chemistry and Residue Data DP# : 391781



### 20 of 40 Table 9

. Summary of Residue Data from Sunflower Field Tr ials with Flumioxazin.

Commodity Adjuvant Total

Rate (lb ai/A) PHI

(days) Residue Levels (ppm) 1

n Sample

Min. Sample

Max. LAFT 2 HAFT 2 Median Mean Std.

Dev.
Sunflower subgroup 20B (proposed use = 0.096 lb ai/A total application rate, 5

- day PHI)

1x R ate

Sunflower

seed NIS 0.097

- 0.098 5 4 0.03 0.18 0.04 0.18 0.13 0.12 0.06

MSO 0.094

- 0.099 4

- 5 7 0.03 0.34 0.03 0.29 0.06 0.11 0.10

NIS/MSO 0.094

- 0.099 4

- 5 11 0.03 0.34 0.03 0.29 0.10 0.11 0.08

2x Rate

Sunflower

seed MSO 0.193

- 0.195 5 2 0.14 0.20 0.1 4 0.17 0.16 0.16 0.02

1 Except for sample min/max, values reflect per trial averages; n = no. of field trials ; for the combined results for NIS and MSO,

side

- by

- side trials were counted as separate trials.

2 LAFT = lowest

- average

- field

- trial; HAFT = hig hest

- average

- field

- trial.



### Conclusions. The submitted sunflower crop field trial data are acceptable

. The stud y reflect s the maximum proposed use pattern for sunflower and safflower , and the number and locations of the

field trials are in accordance with OCSPP 860.1500. An acceptable method was used for residue quantitation, and the data are supported by adequate storage stability data.

The submitted data for sunflower are sufficient for establishing a tolerance of 0. 5 0 ppm associated with the requested registration of the 51% WG formulation s on sunflower

. The tolerance calculations are presented in Appendix I I

.

Wheat

Valent has submitted two wheat field trial studies, one reflecting the proposed pre

- plant weed control use pattern and the collection of wheat forage and hay samples (3 trials) , and one reflecting the foliar harvest aid use pattern and collection of wheat grain and straw samples (26 trials)

. The results of the wheat field trials are presented in Table 10

.

The study design for the wheat fi eld trials was in accordance with EP A recommendations

, resulting from a meeting between R. Loranger (HED) and S. Shen (Valent) on 7/13/09, and subsequent e

- mail correspondence from 7/21/09 to 7/24/09 . The revised meeting minutes ( dated 7/22/09) and e

- mail communication are provided in Appendix 10 of MRID 48510506. The EPA

recommendations are summarized below :

Study design for preplant / preemergence weed control use: Three field trials conducted using the weed control (pre

- plant) use pattern. At each tri al, two plots to be

established : one with a 1x application rate and a 14

- day pre

- plant interval (PPI) , and one with a 2x application rate and a 7

- day PPI

. Forage to be harvested when the 

### plants

reach 5 ” in height (with a corresponding grazing restriction added to the label) ; hay to be collected at the normal harvest timing (early flower (boot) to soft dough stage)

. If residues of flumioxazin in forage and in hay are < LOQ for the samples from the 2x /7

- day PPI application, tolerances for forage and hay wi ll be set at the method LOQ. If residues in either the forage or hay are greater than the LOQ for samples from the 2x/7

- day PPI application

, tolerances will be established based on residue results from the 1x/ 14

- dayFlumioxazin Summary of Analytical Chemistry and Residue Data DP# : 391781



### 21 of 40 PPI application, providing residues are not much higher , and the label will need to be revised to reflect a PPI of 14 days. If residues are significantly above the LOQ from the

1x/14

- day PPI trials, additional trials will likely be required. On the product labels, grazing

should be allowed ba sed on wheat height (5 inches) instead of an interval in days.



### Study design in support of harvest aid (dessication) use: 20 field trials conducted in the regions designated OCSPP 860.1500. Product to be applied 10 days before

harvest . Both spring and winter wheat scenarios to be covered by a wide range of application timing from late May to late September 2009. The residue profile to be used to establish tolerances for straw and grain.

Table 10 . Summary of Residue Data from Wheat Field Trials wit h Flumioxazin.

Commodity Adjuvant Total

Rate (lb ai/A) PHI 3

(days) Residue Levels (ppm) 1

n Sample

Min. Sample

Max. LAFT 2 HAFT 2 Median Mean Std.

Dev.
WHEAT (proposed pre

- plant weed control use = 0.064 lb ai/A total application rate; PHI not specifie d 4 )

1x Rate (7

- 14 days pre

- plant)

Wheat forage NIS 0.062

- 0.064 71

- 129 3 <0.02 <0.02 0.02 0.02 0.02 0.02 N/A

Wheat hay NIS 0.126

- 0.128 172

- 262 3 <0.02 <0.02 0.02 0.02 0.02 0.02 N/A

2x Rate (7 days pre

- plant)

Wheat forage NIS 0.062

- 0.064 64

- 129 3 <0.02 <0.02 0.02 0.02 0.02 0.02 N/A

Wheat hay NIS 0.126

- 0.128 172

- 255 3 <0.02 <0.02 0.02 0.02 0.02 0.02 N/A

WHEAT (proposed harvest aid use = 0.064 lb ai/A total application rate, 10

- day PHI)

1x Rate
Wheat grain NIS 0.062

- 0.066 9

- 11 12 0.03 0.31 0.04 0.31 0. 11 0.12 0.08

MSO 0.063

- 0.064 9

- 11 14 0.03 0.19 0.04 0.16 0.08 0.08 0.03

NIS/

MSO 0.062

- 0.066 9

- 11 26 0.03 0.31 0.04 0.31 0.09 0.10 0.06

Wheat straw NIS 0.062

- 0.066 9

- 11 12 0.21 3.63 0.23 3.22 1.52 1.61 0.88

MSO 0.063

- 0.064 9

- 11 14 0.66 3.95 0.76 3.7 1 1.83 2.09 0.85

NIS/

MSO 0.062

- 0.066 9

- 11 26 0.21 3.95 0.23 3.71 1.73 1.86 0.88

2x Rate

Wheat grain MSO 0.127

- 0.130 9

- 10 3 0.03 0.24 0.04 0.23 0.14 0.14 0.10

Wheat straw 2.11 4.21 2.37 3.63 3.35 3.12 0.66

1 Except for sample min/max, values ref lect per trial averages; n = no. of field trials ; for the combined results for NIS and MSO,

side

- by

- side trials were counted as separate trials.

2 LAFT = lowest average field trial; HAFT = highest average field trial.

3 Wheat forage was harvested at ~5 i n. tall and hay was harvested at early flower (boot) to soft dough stage.

4 The labels include the following grazing restriction: Do not graze until wheat has reached 5 inches in height

.



### Pre

- Plant Application Valent U.S.A. Corporation has submitted fiel d trial data for flumioxazin on wheat

. Three field trials were conducted in the United States during the 2009

- 2010 growing season in the North American Free Trade Agreement (NAFTA) Growing Zones 4 (MS; 1 trial) and 8 (KS and TX; 2 trials).Flumioxazin Summary of Analytical Chemistry and Residue Data DP# : 391781



### 22 of 40 Each trial c onsisted of one untreated plot and two treated plots. At each trial location, one treated plot received a single soil broadcast application of a 51% WG formulation of flumioxazin ( Valor SX 51 WDG) at 0.062

- 0.064 lb ai/A (~1x the maximum proposed seasonal application rate) made 7

- 14 days pre

- planting . A second plot received one application at a 2x rate of 0 .126

- 0.128 lb ai/A made 7 days pre

- planting to evaluate the effect of application rate on residue levels. We note that the target preplanting intervals for the low and high application rates were 14 and 7 days , respectively; however, based on planting and application dates, both plots in the MS trial were treated 7 days pre

- planting. Applications were made using ground equipment in spray

volumes of 19.5

- 20.1 gal/A. An adjuvant (NIS) was added to each spray mixture. Samples of wheat forage were harvested when the wheat plants were ~5 inches tall, at a 64

- to 129

- day PHI; samples of hay were harvested at the early flower (boot) to soft dough stage (172

- to 262

- day PHI) and were allowed to dry in the field for 4

- 5 days prior to collection.

Samples were analyzed for residues of flumioxazin using a n acceptable GC/NPD or GC/MS method, Valent method RM

- 30A

- 3

. The study is supported by adequate storage stabil ity data.

The results of the wheat field trials are presented in Table 10

. Residues of flumioxazin were below the LOQ (<0.02 ppm) in/on all samples of wheat forage and hay harvested 64

- 129 and

172

- 262 days, respectively, following a single soil broadca st application of the 51% WG

formulation of flumioxazin at 0.062

- 0.064 lb ai/A made 7

- 14 days pre

- planting or at a 2x rate of

0.126

- 0.128 lb ai/A made 7 days pre

- planting.

No residue decline data were submitted with the study; these data are not needed to support the

pre

- planting use pattern.

Foliar Application Valent U.S.A. Corporation has submitted field trial data for flumioxazin on wheat for the harvest aid use pattern. Twenty field trials were conducted in the United States during the 2009 growi ng season in the North American Free Trade Agreement (NAFTA) Growing Zones 2 (GA; 1 trial), 4 (MS; 1 trial), 5 (IA, IL, IN, MO, and NE; 5 trials), 7 (MT, ND, and NE; 5 trials), 8 (TX, KS, and OK; 7 trials), and 11 (ID; 1 trial). The two OK trials and two of the NE trials were conducted at

the same trial locations. Careful examination of the field trial records indicates that the two OK trials differed from each other only in the crop variety used, a 1

- day off

- set in initiation, and the

tank mixes used for application. HED has concluded that these trials constitute a single trial with replicate samples for purposes of 860.1500 data requirements. Examination of the field trial records for the NE trials indicates that although the trials reflected the same variety, there were sufficient differences between the trials, including an 11

- day off

- set in initiation, that each trial constitutes a separate trial for purposes of 860.1500 data requirements. The adjustment in trial

numbers results in a total of 19 fie ld trials, with 5 trials conducted in NAFTA Zone 8.

Each trial consisted of one untreated plot and one or two treated plots. At each trial location, one treated plot received one foliar application of a 51% WG formulation of flumioxazin ( Valor SX 51 WDG) at 0.062

- 0.066 lb ai/A (~1x the maximum proposed seasonal application rate). At three trial sites (Carlyle, IL, Norwich, ND, and Wellington, TX), a second plot was treated at a 2x

rate of 0.127

- 0.130 lb ai/A to evaluate the effect of application rate on residue levels. Applications were made using ground equipment in spray volumes of 14.8

- 22.7 gal/A. Adjuvants were added to each spray mixture, with seven trials using a MSO, five trials using aFlumioxazin Summary of Analytical Chemistry and Residue Data DP# : 391781



### 23 of 40 NIS, and seven trials using both in side

- by

- side treated plo ts. Samples of wheat grain and straw were harvested at maturity from all trials at a PHI of 9

- 11 days. At two trials (in MS and OK), additional samples were collected at PHIs of 3

- 4, 7, 10, and 13 days to assess residue decline. Samples of wheat forage and hay were not collected from any trial.

Samples were analyzed for residues of flumioxazin using an acceptable GC/NPD method, Valent

method RM

- 30A

- 3. The study is supported by adequate storage stability data.

The results of the wheat field trials ar e presented in Table 10 . In samples of wheat grain and

straw harvested 9

- 11 days following a single foliar application of the 51% WG formulation of

flumioxazin at 0.062

- 0.066 lb ai/A with an NIS or MSO adjuvant, residues of flumioxazin (and per trial aver ages) were: 0.03

- 0.31 (0.04

- 0.31) and 0.21

- 3.63 (0.23

- 3.22) ppm in/on wheat grain and straw, respectively, following applications made with an NIS; and 0.03

- 0.19 ppm (0.04

- 0.16 ppm) and 0.66

- 3.95 ppm (0.76

- 3.71 ppm) in/on wheat grain and straw, respective ly, following applications made with an MSO. Overall residues (and per trial averages) for applications made with either adjuvant were 0.03

- 0.31 ppm (0.04

- 0.31 ppm) for wheat grain and 0.21

- 3.95 ppm (0.23

- 3.71 ppm) for wheat straw. Side

- by

- side compariso n of residues following applications with NIS and MSO adjuvants suggested that residues in grain were more often slightly higher following applications made with an NIS, while residues in straw were more often higher or slightly higher following applicatio ns made with an MSO.

Following application of flumioxazin at a 2x rate of 0.127

- 0.130 lb ai/A with an MSO adjuvant, residues of flumioxazin (and per trial averages) in/on wheat grain and straw, respectively, were

0.03

- 0.24 (0.04

- 0.23) and 2.11

- 4.21 (2.3 7

- 3.63) ppm. In the straw samples, there was a proportional increase in residues due to the application rate; the grain trials showed no effect on residues due to application rate.

In the residue decline trials, residues of flumioxazin increased in grain from the 10

- day to the 13

- day PHI in one trial (average residues of 0.07 and 0.18 ppm, respectively), but decreased slightly in the second trial (average residues of 0.11 and 0.09 ppm, respectively). In wheat straw,

residues declined or did not increase from the 10

- to the 13

- day PHI.

Conclusions. The submitted wheat crop field trial data are acceptable and reflect HED’s recommendations for support ing pre

- plant and harvest aid uses of flumioxazin on wheat

. For the preplant trials, the stud y reflect s t hree trials conducted at the maximum proposed use pattern , and

the application and sampling timing are in accordance with Agency recommendations. For the harvest aid trials, t he stud y reflect s the maximum proposed use pattern

, and the number and

locations of the field trials are in accordance with OCSPP 860.1500. An acceptable method was used for residue quantitation, and the data are supported by adequate storage stability data.

The submitted data for wheat reflecting application at ~0.064 lb ai/A (foli ar and pre

- plant applications) are sufficient for establishing tolerances for wheat commodities associated with the requested registration of the 51% WG formulations on wheat: the data will support tolerances at the LOQ of 0.02 ppm for forage and hay , and tolerances of 0.4 0 and 6 .0 ppm for wheat grain and

straw. The tolerance calculations for wheat grain and straw are presented in Appendix I I.Flumioxazin Summary of Analytical Chemistry and Residue Data DP# : 391781



### 24 of 40 860.1520 Processed Food and Feed

DER References: 48510501.de2 ( C anola )

48510504.de2 ( S unflower )

48510505.de 2 ( W heat)



### There are no processed commodities associated with the proposed use on field pea. Valent Corporation has submitted processing data for canola, sunflower, and what. The processing

factors are summarized in Table 1 1

.

Table 11 Summary of Proces sing Factors for Flumioxazin

RAC Processed

Commodity Total Rate

lb ai/A ( maximum proposed

seasonal application rate) PHI

(days) Flumioxazin

(ppm) Processing

Factor Theoretical

Maximum

Concentration

Factor 1

Canola Canola 0.483 (

~ 5 ) 5 0. 5

- - -- Oil 0 .0 2 <0.04x 3.0x

Meal 0.0 6 0.1x 1.9x

Sunflower Sunflower seed 0.486 (

~ 5) 5 2.31

- - -- Oil <0.02 <0.01x 2.5x

Meal 0.15 0.06x 4.5x

Wheat Grain 0.307 (~5) 10 0.36

- - -- Bran 0.34 0.9x 7.7x

Flour 0.05 0.1x 1.4x Middlings 0.08 0.2x

-- Shorts 0.11 0.3x 8.3x

Germ 0.37 1.0x

-- AGF 111 308x

-- 1 Based on OCSPP Guidelines 860.1520, Table 3.



### Canola

Valent U.S.A. Corporation has submitted a processing study for flumioxazin on canola. In one trial conducted in WA, a 51% WG form ulation of flumioxazin ( Valor SX 51 WDG) was applied as a single foliar application to canola at an exaggerated rate of 0.483 lb ai/A (~5x the maximum proposed seasonal application rate) in a spray volume of 20.1 gal/A. A n adjuvant (MSO) was added to the spray mixture . Canola seed was harvested at a 5

- day PHI and was dried in the field for 9 days, after which it was processed into oil and meal using simulated commercial procedures. Processing was conducted by GLP Technologies, Inc. (Navasota, TX). Adequ ate descriptions were provided of the processing procedures, including material balance summaries.

Samples were analyzed for residues of flumioxazin using a n acceptable GC/NPD method, Valent

method RM

- 30A

- 3

. The study is supported by adequate storage sta bility data.

The processing factors for canola are summarized in Table 1 1

. Average residues of flumioxazin

were 0.51 ppm in/on canola and 0.06 ppm in meal; residues were below the LOQ (<0.02 ppm) inFlumioxazin Summary of Analytical Chemistry and Residue Data DP# : 391781



### 25 of 40 oil. The processing data indicate that residues of f lumioxazin do not concentrate in oil or meal (processing factors of <0.04x and 0.1x, respectively).

T he processing factors calculated in this study were less than the maximum theoretical

concentration factor s for canola of 1.9 x for meal and 3.0x for oil ( based on separation into
components ; OCSPP 860.1520, Table 3 ).

Conclusions . The submitted processing study is adequate. The data indicate that flumioxazin

does not concentrate in oil or meal f ollowing processing of canola seed bearing quantifiable

res idues following application of Flumioxazin at 5x the maximum proposed seasonal application

rate

.

T he available data indicate that tolerances are not needed for the regulated commodities of canola

oil and meal.

Sunflower

Valent U.S.A. Corporation has submitted a processing study for flumioxazin on sunflower. In one trial conducted in OK, a 51% WG formulation of flumioxazin ( Valor SX 51 WDG) was applied as a single foliar application to sunflower at an exaggerated rate of 0.486 lb ai/A (~5x the

maximu m proposed seasonal application rate) in a spray volume of 15.3 gal/A. A n adjuvant (MSO) was added to the spray mixture . Sunflower seed was harvested at a 5

- day PHI and was processed into oil and meal using simulated commercial procedures . Processing wa s conducted by GLP Technologies, Inc. (Navasota, TX) . Adequate descriptions were provided of the processing procedures, including material balance summaries

.

Samples were analyzed for residues of flumioxazin using a n acceptable GC/NPD or GC/MS method, Va lent method RM

- 30A

- 3

. The study is supported by adequate storage stability data.

The processing factors for sunflower are summarized in Table 1 1

. Average residues of flumioxazin were 2.31 ppm in/on sunflower seed and 0.15 ppm in meal; residues were be low the LOQ (<0.02 ppm) in oil. The processing data indicate that residues of flumioxazin do not concentrate in oil and meal (processing factors of <0.01x and 0.06x, respectively).

T he processing factors calculated in this study were less than the maxi mum theoretical

concentration factor s for sunflower of 4.5 x for meal and 2.5x for oil ( based on separation into
components ; O CSPP 860.1520, Table 3 ).

Conclusions . The submitted sunflower processing study is adequate. The data indicate that

flumioxazin d oes not concentrate in oil or meal f ollowing processing of sunflower seed bearing quantifiable residues following application of Flumioxazin at 5x the maximum proposed seasonal application rate

.

T he available data indicate that tolerances are not needed for the regulated commodities of

sunflower oil and meal.

WheatFlumioxazin Summary of Analytical Chemistry and Residue Data DP# : 391781



### 26 of 40 Valent U.S.A. Corporation has submitted a processing study for flumioxazin on wheat. In one trial conducted in OK, a 51% WG formulation of flumioxazin ( Valor SX 51 WDG) was applied

as a si ngle foliar application to wheat at an exaggerated rate of 0.307 lb ai/A (~5x the maximum proposed seasonal application rate) in a spray volume of 16.2 gal/A. A n adjuvant (MSO) was added to the spray mixture . Wheat grain was harvested at a 10

- day PHI and was processed into bran, flour, middlings, shorts, germ, and AGF using simulated commercial procedures

. Processing was conducted by GLP Technologies, Inc. (Navasota, TX) . Adequate descriptions were provided of the processing procedures, including materi al balance summaries

.

Samples were analyzed for residues of flumioxazin using a n acceptable GC/NPD method, Valent

method RM

- 30A

- 3

. The study is supported by adequate storage stability data.

The processing factors for wheat are summarized in Table 1 1

. Average residues of flumioxazin were 0.36 ppm in wheat grain, 0.34 ppm in bran, 0.05 ppm in flour, 0.08 ppm in middlings, 0.11 ppm in shorts, 0.37 ppm in germ, and 111 ppm in AGF. The processing data indicate that residues of flumioxazin may concentrate in AGF (308x), but do not concentrate in bran, flour, middlings, shorts, or germ (processing factors of 0.9x, 0.1x, 0.2x, 0.3x, and 1.0x, respectively).

T he processing factors calculated in this study were less than the maximum theoretical

concentration factor s for wheat of 7.7 x for bran, 1.4x for flour, and 8.3x for shorts ( based on separation into components ; OCSPP 860.1520, Table 3 ).

Conclusions . The submitted wheat processing study is adequate

. The data indicate that

flumioxazin may concentrate in AGF (308x), but does not concentrate in bran, flour, middlings, shorts, or germ.

T he available data indicate that tolerances are not needed for the regulated commodities of wheat bran, flour, middlings, shorts, or germ. Based the 308x processing factor for AGF and the HAFT residue of 0.31 ppm for wheat grain, the maximum expected residues in AGF are 96 ppm. A

tolerance of 100 ppm is needed for grain, aspirated fractions.

860.1650 Submittal of Analytical Reference Standards

Analyt ical reference standards for flumioxazin and metabolites are currently available at the EPA National Pesticide Standards Repository (personal communication with T. Cole, ACB, 1/3/12) as follows: flumioxazin (expiration 4/1/2012 ), f lumioxazin metabolite 482

- HA (expiration 10/13/2013), and f

lumioxazin metabolite APF (expiration 10/12/2013).

Because the standard s for flumioxazin is due to expire, the registrant must either recertify the lot in the repository and send in an updated certificate of analysis (C OA), or submit a new standard (different lot #) if the previous lots will not be recertified.

If a new COA is being submitted, it should be faxed to the repository at 410

- 305

- 2999. I f new standards are being submitted, they should be sent to the Analy tical Chemistry Lab, which is located at Fort Meade, Maryland. They can be sent to the attention of either Theresa Cole or Thuy Nguyen at the address listed below. The full 9

- digit zip code is mandatory or the mail will be returned to the registrant.Flumioxazin Summary of Analytical Chemistry and Residue Data DP# : 391781



### 27 of 40 US EPA National Pesticide Standards Repository/Analytical Chemistry Branch/OPP 701 Mapes Road Fort George G. Meade, MD 20755

- 5350

The letter of transmittal should include the assay of the standards, names of the analytical methods used, a statement of princ ipal impurities, purification procedures employed, storage requirements, and special precautions for safe handling. Replacement of standards may be required periodically if supplies are exhausted or if decomposition occurs during storage. Material Safety Data Sheets (MSDSs) must accompany all analytical standards as specified by Occupational Safety and Health Administration (OSHA) in 29 CFR 1910.1200.

860.1850/860.1900 Confined and Field Accumulation in Rotational Crops

Residue Chemistry Memo D P # 259493

, 3/12/01 , D. Dotson Residue Chemistry Memo D P # 272652, 3/12/01 , R. Loranger



### The previously submitted confined rotational crop study is adequate for the proposed uses on the requested commodities

. HED has concluded that the residue of concern in rotation al crops is the parent compound only. Based on the results of the confined accumulation study, HED conclude d

that the existing rotational crop plantback intervals (PBIs) are acceptable, and that field trials and

tolerances in rotated crops are not necessa ry.

Current label directions for both 51% WG formulations include the following statement: Do not plant any crop except cotton, peanut, soybean and sugarcane earlier than 30 days after application of flumioxazin. In addition, the labels specify a variet y 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 12

- 18 months for all other crops not listed.

860.1550 Proposed Tolerance s

Tolerances for plant commodities are established under 40 CFR §180.568(a) for residues of

flumioxazin per se

. The tolerance expression proposed by the petitioner is appropriate.

Th e proposed and recommended tolerance for flumioxazin resulting from the subject action are

listed in Table 1 2

.

Adequate field trial data reflecting the proposed use patterns are available for purposes of establishing tolerances for p ea and bean, dried she lled, except soybean, subgroup 6C; r apeseed subgroup 20A; sunflower subgroup 20B; and wheat grain, straw, forage, and hay.

Residues in/on wheat forage and hay were below the LOQ; the available data will support the proposed tolerances at the LOQ of 0.02 p pm for these commodities.

Residues of flumioxazin were quantifiable in/on canola seed, dried pea, sunflower, and wheat grain and straw; therefore, the OECD tolerance calculation procedures were utilized inFlumioxazin Summary of Analytical Chemistry and Residue Data DP# : 391781



### 28 of 40 determining an appropriate tolerance level for th ese commodities

. The tolerance calculations are presented in Appendix II

. Using the OECD tolerance calculation procedures, the recommended

tolerances are : 0.07 ppm dried pea , 0.40 ppm for rapeseed subgroup 20A

, 0.50 for sunflower subgroup 20 B, 0.40 ppm for wheat grain, and 6.0 ppm for wheat straw. Although we were unable to confirm the means by which the petitioner established their proposed tolerances, HED believes the difference in the proposed and recommended tolerances for dried pea
, rapeseed subgr oup 20A, and wheat grain and straw are due to the petitioner’s having used the NAFTA tolerance calculation procedures in determining the proposed tolerance.

The petitioner is proposing a tolerance on p ea and bean, dried shelled, except soybean, subgroup

6C

. Adequate field trial data are available reflecting the established/proposed use patterns on

dried bean (maximum residues 0.05 ppm) and dried pea seed (maximum residues 0.065 ppm)

. A tolerance of 0.05 ppm is currently established for dry bean ; the rec ommended tolerance for dried

pea is 0.07 ppm

. Because the maximum residues in dried bean and dried pea differ by < 5x, a

crop sub group tolerance is appropriate for p ea and bean, dried shelled, except soybean, subgroup

6C at the maximum recommended toleranc e level of 0.07 ppm

.

Adequate canola, sunflower, and wheat processing data have been submitted. The data indicate that tolerances are not needed for canola, sunflower, or wheat processed commodities . However,

a tolerance of 100 ppm is now needed for g rain, aspirated fractions based on the concentration factor of 308x for AGF and the HAFT residue of 0.31 ppm for wheat grain

.

There are no Codex, Canadian or Mexican MRLs for flumioxazin ; therefore, there are no issues

of international harmonization raise d by this action. An International Residue Limit Status Sheet (IRLS) follows the references in this document.

Table 1 2

. Tolerance Summary for Flumioxazin.

Commodity Established/ Proposed Tolerance (ppm) Recommended

Tolerance (ppm) Comments;

Correct Com modity Definition

Dried shelled pea and bean (except soybean), Crop Subgroup 6C, seed 0.1 0.07 Pea and bean, dried shelled, except soybean, subgroup 6C

Bean, dry seed 0. 05 Remove

Rapeseed, Crop Subgroup 20A, seed 0.35 0.4 0 Rapeseed subgroup 20A

Rapes eed Crop Subgroup 20A, meal 0.04

-- Residues in canola meal and oil will be covered by the recommended tolerance for rapeseed subgroup 20A. Rapeseed Crop Subgroup 20A, refined oil 0.02

--

Sunflower, Crop Subgroup 20B, seed 0.5 0.5 0 Sunflower subgroup 20 B

Sunflower, Crop Subgroup 20B, meal 0.03

-- Residues in sunflower meal and oil will be covered by the recommended tolerance for rapeseed subgroup 20A. Sunflower, Crop Subgroup 20B, refined oil 0.02

--

Wheat, forage 0.02 0.02

Wheat, hay 0.02 0.02

W heat, grain 0.35 0.4 0Flumioxazin Summary of Analytical Chemistry and Residue Data DP# : 391781



### 29 of 40 Table 1 2

. Tolerance Summary for Flumioxazin.

Commodity Established/ Proposed Tolerance (ppm) Recommended

Tolerance (ppm) Comments;

Correct Com modity Definition

Wheat, straw 5 6 .0

Grain, aspirated fraction 110 100 Grain, aspirated fractions

Wheat, bran 0.35

-- Residues in wheat bran, flour, germ, middlings, and shorts will be covered by the recommended tolerance for wheat grain. Wheat, flour 0.05

-- Wheat, germ 0.35

-- Wheat, middlings 0.08

-- Wheat, shorts 0.11

--



### References

DP# : 194594 Subject: PP# 3G4250: New Chemical EUP: V

- 53482, Flumioxazin on Soybeans.

Evaluation of Analytical Methods and of Res idue Data.

From: J. Garbus

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

Dated: 9/ 21/1994 MRID(s): 42884011

- 42884014, 42884016

- 42884019

DP# : None Subject: PP# 3 G4250: New Chemical EUP: Flumioxazin: Revised Tolerance

Enforcement Met hod.

From: J. Garbus

To: J. Miller

Dated: 1/ 08 / 19 96 MRID(s): 43935509

DP#s : 259493 and 268181 Subject: PP#s 7F4841 and 0F6171. Tolerance Petitions for the Use of Flumioxazin on

Peanuts, Soybeans, and Sugarcane. Evaluation of Re sidue Chemistry and Analytical Methodology

From: D. Dotson

To: D. Kenny and J. Miller

Dated: 3/ 12 / 20 01 MRID(s): 44013001, 44013002, 44295049

- 44295057

DP# : 272652 Subject: PP# 7F4841/0F6171; Flumioxazin in/on Peanuts, Soybeans a nd Sugarcane.

Conclusions of the 12/20/2000 Meeting of the Metabolism Assessment Review

Committee.

From: R. Loranger

To: Y. Donovan

Dated: 3/ 12 / 20 01 MRID(s): NoneFlumioxazin Summary of Analytical Chemistry and Residue Data DP# : 391781



### 30 of 40 DP# : 298647 Subject: Flumioxazin. Tolerance Petition Requesting Section 3 Registration for Food Use

of Flumioxazin on Cotton. Summary of Analytical Chemistry and Residue Data.

Petition Number 1F06296.

From: W. Drew

To: J. Miller

Dated: 2/ 17 / 20 04 MRID(s): 45375506

DP# : 301247 Subject: Flumio xazin. 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 Chemi stry and Residue Data. Petitions Numbered 0F06171, 1F06296, 3E06777, 3E06779, 3E6788.

From: W. Drew

To: Joanne Miller/James Stone

Dated: 7/ 23/2004 MRID(s): 45244801, 45375503, 45375504, 45375505, 45375507, 45888501, 46109201,

46114601, 46133901

DP#s : 310408 and 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 Res idue

Data.

From: W. Drew

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

Dated: 3/ 15 / 20 06 MRID(s): 46229401, 46229402, 46229403, 46229404, 46229405, 46229406, 46229407,

46229408, 46292501

DP# : 342963 Subject: Flumioxazin. Petitions for Tolerances on Alf alfa, 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: 6F7 092 and

6E7151.

From: D. Rate

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

Dated: 11/2 0/2007 MRID(s): 46889603, 46889604, 47005101, 47005102, 47005103, 47005104, 47005105,

47005106, 47005107Flumioxazin Summary of Analytical Chemistry and Residue Data DP# : 391781



### 31 of 40 DP# : 342413 Subject: Flumioxazin. Petition for the Establishment of Permanent Tolerances on Field

Corn Commodities. Summary of Analytical Chemistry and Residue Data.

PP#7E7243.

From: D. Rate

To: B. Hanson

Dated: 1/31/2008 MRID(s): 47184801

Attachments:

International Residue Limit Status she et Appendix I

- Chemical Names and Structures of Flumioxazin Residues of Concern. Appendix II

- Tolerance Assessment CalculationsFlumioxazin Summary of Analytical Chemistry and Residue Data DP# : 391781



### 32 of 40 

## International Residue Limits

Flumioxazin (129034; 1/9/12)

Summary of US and International Tolerances and Maximum Residue L imits Residue Definition :
US Canada Mexico 2 Codex 3



### 40 CFR 180.568:

Plant: flumioxazin, 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, including its metabolites and degradates.

Compliance with the tolerance levels is to be determined by measuring only flumioxazin.



### Livestock: N/A 

### None None



### Commodity 1 

### Tolerance (ppm) /Maximum Residue Limit (mg/kg)

US Canada Mexico 2 

### Codex 3



### Pea and bean, dried shelled, except soybean, subgroup 6 C 0.07

Rapeseed subgroup 20A 0.4 0 Sunflower subgroup 20B 0.5 0 Wheat, forage 0.02 Wheat, hay 0.02 Wheat, grain 0.4 0
Wheat, straw 6.0
Grain, aspirated fraction s 10 0

Completed:

1 Includes only c ommodities of interest for this action. Tolerance values should be the HED recommendations and not those proposed by the applicant.

2 Mexico adopts US tolerances and/or Codex MRLs for its export purposes.

3 * = absent at the limit of quantitation; Po = p ostharvest treatment, such as treatment of stored grains. PoP = processed postharvest treated commodity, such as processing of treated stored wheat. (fat) = to be measured on the fat portion of the sample. MRLs indicated as proposed have not been finalize d by the CCPR and the CAC.Flumioxazin Summary of Analytical Chemistry and Residue Data DP# : 391781



### 33 of 40 Appendix I. Chemical N ames and Structures of Flumioxazin Residues of Concern.

Common name Chemical name Chemical structure

Flumioxazin 2

- [7

- fluoro

- 3,4

- dihydro

- 3

- oxo

- 4

- (2

- propynyl)

- 2 H

- 1,4

- benzoxazin

- 6

- yl]

- 4,5,6,7

- tetrahy dro

- 1H

- isoindole

- 1,3(2H)

- dione

3

- OH

- Flumioxazin 7

- fluoro

- 6

- (3

- hydroxy

- 3,4,5,6

- tetrahydrophthalimido)

- 4

- (2

- propynyl)

- 2H

- 1,4

- benzoxazin

- 3(4H)

- one

4

- OH

- Flumioxazin 7

- fluoro

- 6

- (4

- hydroxy

- 3,4,5,6

- tetrahydrophthalimido)

- 4

- (2

- propynyl)

- 2H

- 1,4

- benzoxazin

- 3(4H)

- one

Metabolite B , F Not available

Metabolite C Not availableFlumioxazin Summary of Analytical Chemistry and Residue Data DP# : 391781



### 34 of 40 Common name Chemical name Chemical structure

4

- OH

- S

- 53482

- SA 7

- fluoro

- 6

- (1

- sulfo

- 4

- hydroxy

- 1,2

- cyclohexa nedicarboximido)

- 4

- (2

- propynyl)

- 2H

- 1,4

- benzoxazin

- 3(4H)

-

one

482

- HA [Fish] N

- (7

- fluoro

- 3,4

- dihdyro

- 3

- oxo

- 4

- prop

- 2

- ynyl

- 2H

- 1,4

- benzoxazin

- 6

- yl)cyclohex

- 1

- ene

- 1

- carboxamide

- 2

- carboxylic acid

APF [Fish ] 3

- oxo

- 4

- prop

- 2ynyl

- 6

- amino

- 7

- fluoro

3,4

- dihydro

- 1,4

- benzoxazin

Metabolite B, C, & F structures are not fully characterized (with Metabolite B & Metabolite F associated with Goat milk, liver, & kidney; and Metabolite C associated with Goat milk, kidney, and muscle).Flumioxazin Summary of Analytical Chemistry and Residue Data DP# : 391781



### 35 of 40 Appendix II. Tolerance Assessment Calculations

.

T he OECD tolerance calculation procedures (March 2011 version), were used for calculating

recommended tolerances for canola, dried pea, sunflower, wheat grain, and whe at straw. The statistical goal of the OECD tolerance calculation procedures is to produce an MRL proposal in the region of the 95 th 

### percentile of the underlying residues distribution. The average residue values used to calculate the tolerances are provid ed in Table I

- 1.

Table I

- 1. Residue data used to calculate tolerances for flumioxazin

. Regulator: EPA

Chemical: F lumioxazin

Crop: Canola Dried Pea Sunflower Wheat Grain Wheat Straw

PHI: 4

- 5 4

- 6 5 10

- 11 10

App. Rate: 0.096 0.096 0.096 0.064 0.064

S ubmitter: Valent U.S.A.

Corporation Valent U.S.A.

Corporation Valent U.S.A.

Corporation Valent U.S.A.

Corporation Valent U.S.A.

Corporation

MRID

Citations: 48510501 48510502 and

48510503 48510504 48510505 48510505

Flumioxazin (ppm)

0.04 0.0 19 0.04 0.0 4 1.82

0.05 0.026 0.03 0.05 3.71

0.16 0.02* 0.04 0.11 2.55

0.06 0.02* 0.05 0.08 0.76

0.03 0.02* 0.1 0 0.05 0.94

0.04 0.02* 0.14 0.04 1.83

0.07 5 0.02* 0.18 0.11 1.46

0.25 5 0.02* 0.18 0.08 1.26

0.04 0.02* 0.06 0.13 1.84

0.07 0.02* 0.12 0.11 2.35

0.06 0.02* 0.29 0.23 0.85

0.021 0.16 1.59

0.021 0.12 3.22

0.03 0.09 3.4 0

0.056 0.06 1.57

0.135 0.06 1.74

0.0125 0.07 3.2 0

0.09 1.06

0.1 0 1.55

0.31 3.19

0.13 1.71

0.05 1.83

0.1 0 0.23

0.06 1.8 8

0.1 1.57

0.05 1.37

*censored valuesFlumioxazin Summary of Analytical Chemistry and Residue Data DP# : 391781



### 36 of 40 MSO= methylated seed oils ; NIS= non

- ionic surfactants, COC= crop oil concentrates



### Canola

The dataset used to establish a tolerance for flumioxazin on canola consisted of field trial data representing ap plication rates of 0.092

- 0.101 lb ai/A lb ai/A flumioxazin with a 4

- to 5

- day PHI. The field trial application rates and PHI are within 25% of the maximum label application rate and minimum label PHI. The average residue values used to calculate the tole rance are provided

in Table I

- 1. R esidues of flumioxazin were quantifiable (LOQ = 0.02 ppm) in/on samples from

all trials

. Data reflecting applications made with both the NIS and MSO adjuvants were

combined for the tolerance calculation. Using the OECD tolerance calculation procedures, the

recommended tolerance is 0.4 0 ppm for residues of flumioxazin in/on canola.

Flumioxazin

Canola

USA

0.096 lb ai/A, 5

- day PHI

Total number of data (n) 11

Percentage of censor ed data 0%

Number of non

- censored data 11

Lowest residue 0.030

Highest residue 0.25 5

Median residue 0.06 0

Mean 0.0 80

Standard deviation (SD) 0.06 8

Correction factor for censoring (CF) 1.000

Proposed MRL esti mate

- Highest residue 0.250

- Mean + 4 SD 0.346

- CF x 3 Mean 0.235

Unrounded MRL 0.346

Rounded MRL 0.4Flumioxazin Summary of Analytical Chemistry and Residue Data DP# : 391781



### 37 of 40 Dried Pea

The dataset used to establish a tolerance for flumioxazin on dried pea consisted of field trial data representing application rates of 0.093

- 0.100 lb ai/A lb ai/A flumioxazin with a 4

- to 6

- day PHI. The field trial application rates and PHI are within 25% of the maximum label application rate

and minimum label PHI. The average residue values used to calculate the tolerance are provided

in Table I

- 1. R esidues of flumioxazin were quantifiable (LOQ = 0.02 ppm) in/on samples from 6

of 15 trials

. Data reflecting applications made with both the NIS and MSO adjuvant s were combined for the tolerance calculation. Using the OECD tolerance calculation procedures, the

recommended tolerance is 0.07 ppm for residues of flumioxazin in/on dried pea

.

Flumioxazin

Dried Pea

USA

0.096 lb ai/A, 5

- day PH I

Total number of data (n) 15

Percentage of censored data 60%

Number of non

- censored data 6

Lowest residue 0.020

Highest residue 0.056

Median residue 0.020

Mean 0.024

Standard deviation (SD) 0.009

Corre ction factor for censoring (CF) 0.600

Proposed MRL estimate

- Highest residue 0.056

- Mean + 4 SD 0.061

- CF x 3 Mean 0.043

Unrounded MRL 0.061

Rounded MRL 0.07

High uncertainty of M RL estimate.

[High level of censoring]Flumioxazin Summary of Analytical Chemistry and Residue Data DP# : 391781



### 38 of 40 Sunflower

The dataset used to establish a tolerance for flumioxazin on sunflower consisted of field trial data representing application rates of 0.094

- 0.099 lb ai/A lb ai/A flumioxazin with a 4

- t o 5

- day PHI. The field trial application rates and PHI are within 25% of the maximum label application rate and minimum label PHI. The average residue values used to calculate the tolerance are provided

in Table I

- 1. R esidues of flumioxazin were quantif iable (LOQ = 0.02 ppm) in/on samples from

all trials

. Data reflecting applications made with both the NIS and MSO adjuvants were

combined for the tolerance calculation. Using the OECD tolerance calculation procedures, the

recommended tolerance is 0.5 0 pp m for residues of flumioxazin in/on sunflower.

Flumioxazin

Sunflower

USA

0.096 lb ai/A, 5

- day PHI

Total number of data (n) 11

Percentage of censored data 0%

Number of non

- censored data 11

Lowest resid ue 0.030

Highest residue 0.290

Median residue 0.100

Mean 0.112

Standard deviation (SD) 0.081

Correction factor for censoring (CF) 1.000

Proposed MRL estimate

- Highest residue 0.290

- Mean + 4 SD 0.436

- CF x 3 Mean 0.335

Unrounded MRL 0.436

Rounded MRL 0.5Flumioxazin Summary of Analytical Chemistry and Residue Data DP# : 391781



### 39 of 40 Wheat

The dataset used to establish a tolerance for flumioxazin on wheat grain and straw consisted of field trial data representing application rates of 0.062

- 0.066 lb ai/A lb ai/A flumioxazin with a 9

- to 11

- day PHI. The field trial application rates and PHI are within 25% of the maximum label application rate and minimum label PHI. The average residue values used to calculate the tolerance are provided in Table I

- 1. R esidues of flumioxazin were quantifiable (LOQ = 0.02 ppm) in/on samples from all trials

. Data reflecting applications made with both the NIS and MSO adjuvants were combined for the tolerance calculation. Using the O ECD tolerance calculation procedures, the recommended tolerance s are 0.4 0 and 6.0 ppm for residues of flumioxazin in/on wheat grain and straw, respectively

. No detectable residues of flumioxazin (<0.01 ppm) were found in wheat forage and hay samples.

Flumioxazin

Wheat Grain

USA

0.064 lb ai/A

Total number of data (n) 26

Percentage of censored data 0%

Number of non

- censored data 26

Lowest residue 0.040

Highest residue 0.310

Median residue 0.0 90

Mean 0.099

Standard deviation (SD) 0.060

Correction factor for censoring (CF) 1.000

Proposed MRL estimate

- Highest residue 0.310

- Mean + 4 SD 0.341

- CF x 3 Mean 0.298

Unrounded MRL 0.341

Rounded MRL 0.4Flumioxazin Summary of Analytical Chemistry and Residue Data DP# : 391781



### 40 of 40 Flumioxazin

Wheat straw

USA

0.064 lb ai/A, 10

- day PHI

Total number of data (n) 26

Percentage of censored data 0%

Number of non

- censored data 26

Lowest residue 0.230

Highest residue 3.710

Median residue 1.725

Mean 1.865

Standard deviation (SD) 0.882

Correction factor for censoring (CF) 1.000

Proposed MRL estimate

- Highest residue 3.710

- Mean + 4 SD 5.391

- CF x 3 Mean 5.594

Unrounded MRL 5.594

Rounded MRL 6