Document ID: EPA-HQ-OPP-2007-0308-0006
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2008-03-05T05:00Z

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, D.C.  20460

OFFICE OF              

PREVENTION, PESTICIDES

AND TOXIC SUBSTANCES 

MEMORANDUM

Date:  	30/OCT/2007

Subject:	Flumioxazin.  Acute and Chronic Dietary (Food and Water)
Exposure Assessments for Section 3 Registration for Tolerances in/on
Alfalfa, Asparagus, Dry Beans, Fruiting Vegetables (Group 8, including
Okra), Melon (Subgroup 9A), Bushberries (Subgroup 13B), and Tree Nuts
(Group 14).

Petition Numbers:			6F7092, 6E7151

Regulatory Citation:			40CFR §180.568

PC Code (Chemical Number):	129034

DP Number:				342753

Chemical Class:			N-phenylphthalimide Herbicide

Trade Names:			Chateau(

EPA Registration Numbers:	59639-119

From:		Debra Rate, PhD, Biologist

Alternative Risk Integration and Assessment (ARIA) Team 

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

Registration Division (7505P)

Through:	Sheila Piper, Chemist

David Soderberg, Chemist

Dietary Exposure Science Advisory Council

Health Effects Division (7509P)

		William Cutchin, Acting Senior Branch Scientist

		ARIA

		RIMUERB/RD (7505P)

To:		Daniel Rosenblatt, Branch Chief

	RIMUERB

		RD (7505P)

	Joanne Miller / James Stone

	Herbicide Branch (HB)/RD (7505P)

Executive Summary

The purpose of this memorandum is to report the results of a dietary
exposure analysis for flumioxazin.  In this analysis, the acute and
chronic dietary exposure and risk estimates resulting from food and
water intake were determined for the general U.S. population and various
population subgroups.

Acute and chronic dietary risk assessments were conducted using the
Dietary Exposure Evaluation Model (DEEM-FCID(, Version 2.03), which uses
food consumption data from the USDA’s Continuing Surveys of Food
Intakes by Individuals (CSFII) from 1994 to 1996, and 1998.  These
analyses were performed to support Section 3 requests(PP#6F7092 and
6E7151) to establish tolerances for residues of flumioxazin in/on
alfalfa, asparagus, bean, dry seed, fruiting vegetables (group 8,
including okra), melon (subgroup 9a), tree nuts (group 14) and a number
of berry crops.  

Both the acute and chronic exposure analyses were based on the following
assumptions which result in conservative estimates of dietary exposure
and risk:

Tolerance level residues of flumioxazin in/on all current RACs (e-CFR 40
§180.568, Updated Sept. 6, 2007) and recommended tolerance level
residues of proposed RACs (DP Num: 342963, D. Rate, pending).

Empirical processing factors obtained from processing studies (when
available; including tomato commodities).

DEEM 7.81 default processing factors were used for the remaining
processed commodities.

100% crop treated (CT), and

0.048 ppm flumioxazin estimated drinking water concentrations (EDWCs)
(DP Num: D336195, 342249, 331732; L. Liu; 25/SEP/2007).  

In calculating dietary risk estimates, ARIA has compared both the acute
population-adjusted dose (aPAD) and the chronic population-adjusted dose
(cPAD) to the respective estimated dietary exposures.  Typically, ARIA
has concerns regarding dietary risk when the estimates exceed 100% of
the aPAD or cPAD.  With the conservative assumptions noted above, risk
estimates associated with dietary exposure to flumioxazin are
significantly below ARIA’s level of concern.  

Acute Dietary Exposure Results and Characterization.  

The EDWCs used in the acute dietary exposure was determined to be 0.048
ppm (ground water) by the Environment Fate and Effects Division (EFED)
based on residues from flumioxazin (parent compound, 482-HA and APF)
(See Attachment 4).  An acute endpoint was selected for only one
population subgroup, females 13-49.  This subgroup had a risk estimate
below ARIA’s level of concern, utilizing 8% of the aPAD at the 95th
percentile of exposure.  

Chronic Dietary Exposure Results and Characterization.  

The EDWCs used in the chronic dietary exposure, because it was the most
conservative, was the same as that used in the acute dietary exposure
assessment (0.048 ppm (ground water)).  The general US population and
all population subgroups had risk estimates below ARIA’s level of
concern.  The most highly exposed population subgroup (all infants <1)
utilizes 18% of the cPAD, while the general US population utilizes 6%.

Cancer Exposure Results and Characterization:

Flumioxazin was classified as “Not likely to be Carcinogenic to
Humans”, therefore, no cancer assessment was performed.

I.	Introduction

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

For acute and non-cancer chronic exposures, ARIA is concerned when
estimated dietary risk exceeds 100% of the PAD.  ARIA is generally
concerned when estimated cancer risk exceeds one in one million (the
risk exceeds 1 x 10-6).  References which discuss the acute and chronic
risk assessments in more detail are available on the EPA/Pesticides web
site, Available Information on Assessing Exposure from Pesticides, A
User’s Guide, 21/JUN/2000 (the web link is
http://www.epa.gov/fedrgstr/EPA-PEST/2000/July/Day-12/6061.pdf), or see
SOP 99.6 of 20/AUG/1999.  

The most recent dietary risk assessment conducted for flumioxazin was
Flumioxazin.  Acute and Chronic Dietary Exposure Assessments for
Tolerances (Associated with Section 18 Registration) in/on Pumpkins; DP
Num: 331788; D. Rate; 22/AUG/2006.  This assessment includes pumpkin
(0.02 ppm) in the RACs used for dietary assessment.  

II.	Residue Information

Tolerances are currently established for residues of the herbicide
flumioxazin in/on various plant commodities, at levels ranging from 0.02
to 0.70 ppm (as listed in 40CFR §180.568[a]).  Previously, residue data
from field trials conducted to support the existing registrations show
that, generally, residues of flumioxazin are low, and that residues do
not concentrate into processed products; therefore, use of default
processing factors in the analysis is considered conservative and will
overestimate dietary exposure.  In conjunction with these new uses, ARIA
recommends in favor of establishing tolerances on the following
commodities at the levels listed: 

Alfalfa, forage	1.1 ppm

Alfalfa, hay	3.0 ppm

Asparagus	0.02 ppm

Fruiting Vegetables, Group 8 	0.02 ppm

Okra 	0.02 ppm

Melon, subgroup 9A	0.02 ppm

Bean, dry, seed	0.05 ppm

Tree Nuts, Group 14	0.02 ppm

Bushberry, subgroup 13B	0.02 ppm

Aronia berry	0.02 ppm

Blueberry, lowbush	0.02 ppm

Blueberry, highbush	0.02 ppm

Buffalo currant	0.02 ppm

Chilean guava	0.02 ppm

Currant, black	0.02 ppm

Currant, red	0.02 ppm

Elderberry	0.02 ppm

European barberry	0.02 ppm

Gooseberry	0.02 ppm

Highbush cranberry	0.02 ppm

Honeysuckle	0.02 ppm

Jostaberry	0.02 ppm

Juneberry, including Saskatoon berry	0.02 ppm

Lingonberry	0.02 ppm

Native currant	0.02 ppm

Salal	0.02 ppm

Sea buckthorn	0.02 ppm

The residue of concern for both the tolerance expression and risk
assessment is flumioxazin per se.  Current and recommended
tolerance-level residues were used for all RACs.  DEEM( 7.81 processing
factors were used for all processed commodities, with the exception of
tomato which used the empirical processing factor of one.  The tomato
processing factor of one is based on an exaggerated (~5x) crop field
trial study in which no residues were recovered; therefore, a processing
study is not required (47005106.der.com, D. Rate, 19/JUN/2007).  One
hundred %CT was assumed for all commodities in this assessment.  

III.	Drinking Water Data

The EDWCs for flumioxazin residues (flumioxazin, 482-HA, and APF) used
in this dietary risk assessment was obtained from EFED’s environmental
risk assessment for flumioxazin, Drinking Water Assessment for: (1) IR-4
Registration for Flumioxazin to be used on Asparagus, Dry Bean,
Bushberry Subgroup 13B, Fruiting Vegetable Subgroup 8, Melon Subgroup
9A, Okra and Tree Nut Subgroup 14; and (2) Section 3 Registration for
Use on Field Corn and Alfalfa; DP Num: D336195, 342249, 331732; L. Liu;
25/SEP/2007.  The hydrolysis study for flumioxazin indicates that
flumioxazin forms the metabolite 482-HA, which can further hydrolyze to
the metabolites APF and THPA.  The rates of the two hydrolytic reactions
are very pH dependent, but flumioxaxin (parent compound) is not very
stable at any likely environmental pH.  Data also indicates that THPA
and APF are likely to be very mobile.  Although THPA can comprise a
major portion of the total residue in water, it does not possess the
phenyl ring and is thus considered significantly less toxic than parent,
APF, and 482-HA.  Thus, THPA has not been included in the residue of
concern for drinking water.  Therefore, parent flumioxazin and the
metabolites 482-HA and APF are the residues of concern in drinking
water.  The EDWCs for flumioxazin residues (used in both the acute and
chronic dietary analyses) was 0.048 ppm, the concentration in
groundwater as estimated by the SCI-GROW model.  SCI-GROW (Screening
Concentration In GroundWater) is an empirical model for predicting
pesticide levels in groundwater; the value from SCI-GROW is considered
an upper bound concentration estimate, and thus conservative.  In order
to be conservative with the estimates, the groundwater EDWC (0.048 ppm),
greater than the surface water EDWC (0.034 ppm), was used in both
dietary analyses.  Table 1 summarizes the drinking water concentrations
provided by EFED.  The model and its description are available at the
EPA internet site:   HYPERLINK
"http://www.epa.gov/oppefed1/models/water/" 
http://www.epa.gov/oppefed1/models/water/ .

Table 1.  EDWCs for flumioxazin and its degradates in surface water and
groundwater at pH 7.

Compound	Average 56-Day Conc. in  Surface Water	Peak Conc. in Surface
Water	Conc. in Groundwater

Flumioxazin	negligible	1.03 ppb	negligible

482-HA	4.84 ppb	6.87 ppb	45.27 ppb

APF	12.85 ppb	26.46 ppb	2.66 ppb

THPA	19.50 ppb	27.67 ppb	182.28 ppb

IV.	DEEM-FCID( Program and Consumption Information

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

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

For acute exposure assessments, individual one-day food consumption data
are used on an individual-by-individual basis.  The reported consumption
amounts of each food item can be multiplied by a residue point estimate
and summed to obtain a total daily pesticide exposure for a
deterministic exposure assessment, or “matched” in multiple random
pairings with residue values and then summed in a probabilistic
assessment.  The resulting distribution of exposures is expressed as a
percentage of the aPAD on both a user (i.e., only those who reported
eating relevant commodities/food forms) and a per-capita (i.e., those
who reported eating the relevant commodities as well as those who did
not) basis.  In accordance with HED policy, per capita exposure and risk
are reported for all tiers of analysis.  However, for tiers 1 and 2, any
significant differences in user vs. per capita exposure and risk are
specifically identified and noted in the risk assessment.

V.	Toxicological Information

The findings of the flumioxazin risk assessment team, relative to
dietary exposure, are summarized in Table 2 (below).  In accordance with
the EPA Draft Guidelines for Carcinogen Risk Assessment (July, 1999),
flumioxazin was classified as “not likely to be carcinogenic to
humans.”  As such, both acute and chronic dietary analyses are
required, while a cancer dietary analysis is not.  

Table 2  Summary of Toxicological Doses and Endpoints for Use in Human
Health Dietary

Risk Assessment for Flumioxazin.  

Exposure/

Scenario	Point of Departure	Uncertainty/FQPA Safety Factors	RfD, PAD,
Level of Concern 	Study and Toxicological Effects

Acute Dietary (General Population, including Infants and Children)	No
endpoint attributable to a single dose (exposure) was identified in the
available studies, including the developmental toxicity studies in rats
and rabbits.  

Acute Dietary

(Females 13-49 years of age)	NOAEL = 3 mg/kg/day

	UFA= 10x

UFH= 10x

FQPA SF = 1X

Total UF = 100X

	Acute RfD =

NOAEL ( UF = 

0.03 mg/kg/day

aPAD = 0.03 mg/kg/day	Oral developmental and supplemental prenatal
studies in the rat.  

LOAEL = 10 mg/kg/day based on cardiovascular effects (especially
ventricular septal defects in fetuses).

Chronic Dietary (All Populations)	NOAEL = 2 mg/kg/day

	UFA= 10x

UFH= 10x

FQPA SF = 1X

Total UF = 100X

	Chronic RfD ( FQPA SF = 0.02 mg/kg/day 

cPAD = 0.02  mg/kg/day	2-year chronic/carcinogenicity study in the rat. 

LOAEL = 18 mg/kg/day based on increased chronic nephropathy in males,
and decreased hematological parameters in females (Hgb, MCV, MCH, and
MCHC).  

Cancer (oral, dermal, inhalation)   	Classification: “Not likely to be
Carcinogenic to Humans” based on the lack of carcinogenicity in a
2-year rat study, an 18-month mouse study, and a battery of mutagenic
studies.  

Point of Departure (POD) = A data point or an estimated point that is
derived from observed dose-response data and  used to mark the beginning
of extrapolation to determine risk associated with lower environmentally
relevant human exposures.  NOAEL = no observed adverse effect level. 
LOAEL = lowest observed adverse effect level.  UF = uncertainty factor. 
UFA = extrapolation from animal to human (intraspecies).  UFH =
potential variation in sensitivity among members of the human population
(interspecies).  UFL = use of a LOAEL to extrapolate a NOAEL.  UFS = use
of a short-term study for long-term risk assessment.  UFDB = to account
for the absence of key data (i.e., lack of a critical study).  FQPA SF =
FQPA Safety Factor.  PAD = population adjusted dose (a = acute, c =
chronic).  RfD = reference dose.  LOC = level of concern.  N/A = not
applicable.



VI.	Results/Discussion

As stated above, for acute or chronic dietary assessments, ARIA is
concerned when dietary risk exceeds 100% of the PAD.  The DEEM-FCID(
analyses estimate the dietary exposure of the US population and various
population subgroups.  The results reported in Table 3 (below) are for
the general US population (total), all infants <1, children 1-2,
children 3-5, children 6-12, youths 13-19, females 13-49, adults 20-49,
and adults 50+ for chronic exposure and females 13-49 for acute
exposure.  

Acute.  The analysis summarized in Table 3 (below) is based on
tolerance-level residues in all RACs (modified by DEEM( processing
factors, Version 7.81, for processed commodities, except for tomato),
and 100% CT assumptions.  Dietary exposure via drinking water was also
included in this assessment.  Even with the conservative assumptions
utilized, the risk estimate is well below ARIA’s level of concern. 
The only population subgroup analyzed is females 13-49, which has an
exposure estimate of 0.002524 mg/kg/day at the 95th percentile, and
utilizes 8% of the aPAD.

Chronic.  The analyses summarized in Table 3 (below) are based on
tolerance-level residues in all RACs (modified by DEEM( processing
factors, Version 7.81, for processed commodities, except for tomato),
and 100% CT assumptions.  Dietary exposure via drinking water was also
included in these assessments.  Even with the conservative assumptions
utilized, the risk estimates are well below ARIA’s level of concern. 
The most highly exposed population subgroup is all infants <1, which has
an exposure estimate of 0.003689 mg/kg/day, and utilizes 18% of the
cPAD.  

TABLE 3	Summary of Dietary Exposure and Risk for Flumioxazin.  

Population Subgroup 1

[Years of Age]	

DEEM Acute Dietary Analysis,

95th Percentile	

DEEM Chronic Dietary Analysis

	

aPAD (mg/kg)	

Exposure (mg/kg/day)	

% aPAD	

cPAD (mg/kg/day)	

Exposure (mg/kg/day)	

% cPAD

General US Population	

NA 2	

0.02	

0.001207	

6

All Infants [<1]

0.02	

0.003689	

18

Children [1-2]

0.02	

0.002168	

11

Children [3-5]

0.02	

0.001958	

10

Children [6-12]

0.02	

0.001299	

7

Youths [13-19]

0.02	

0.000900	

5

Adults [20-49]

0.02	

0.001076	

5

Adults [50+]

0.02	

0.001121	

6

Females [13-49]	

0.03	

0.002524	

8	

0.02	

0.001076	

5

1 Values for the population with the highest risk for each type of risk
assessment are bolded.  

2 NA = Not Applicable; no acute dietary endpoint was identified for
these population subgroups.  

VII.	Characterization of Inputs/Outputs

The assumptions made in this assessment are conservative, and are very
likely to result in exposure and risk values that considerably
overestimate actual dietary exposure to flumioxazin.  

VIII.	Conclusions

Based on conservative assumptions, dietary risk estimates for
flumioxazin do not exceed ARIA’s level of concern for the general US
population, nor any of the population subgroups, including those
comprised of infants and children.  



IX.	List of Attachments

Attachment 1:  Acute and Chronic Residue Input for Flumioxazin using
DEEM-FCID

Attachment 2:  Results of Acute Dietary Exposure Analysis

Attachment 3:  Results of Chronic Dietary Exposure Analysis

Attachment 4:  Chemical Structure of Flumioxazin and metabolites (AFP
and 482-HA)

cc:	William Cutchin and Debra Rate

Attachment 1:  Commodity Contribution List for Flumioxazin

U.S. Environmental Protection Agency                                
Ver. 2.00

DEEM-FCID Chronic analysis for FLUMIOXAZIN                       
1994-98 data

Residue file: E:\ARIA-Flumioxazin\DEEM\129034-090607.R98   Adjust. #2
NOT used

Analysis Date 09-06-2007             Residue file dated:
09-06-2007/15:02:43/8

Reference dose (RfD) = 0.02  (NOEL) = 2 mg/kg bw/day

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

Food Crop                                       Residue      
Adj.Factors      Comment

EPA Code  Grp  Food Name                          (ppm)       

                                                             #1        
#2 

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

14000030 14   Almond                             0.020000   1.000     
1.000   May 2004 new uses

14000031 14   Almond-babyfood                    0.020000   1.000     
1.000   May 2004 new uses

14000040 14   Almond, oil                        0.020000   1.000     
1.000   May 2004 new uses

14000041 14   Almond, oil-babyfood               0.020000   1.000     
1.000   May 2004 new uses

11000070 11   Apple, fruit with peel             0.020000   1.000     
1.000   

11000080 11   Apple, peeled fruit                0.020000   1.000     
1.000   

11000081 11   Apple, peeled fruit-babyfood       0.020000   1.000     
1.000   

11000090 11   Apple, dried                       0.020000   8.000     
1.000   

11000091 11   Apple, dried-babyfood              0.020000   8.000     
1.000   

11000100 11   Apple, juice                       0.020000   1.300     
1.000   

11000101 11   Apple, juice-babyfood              0.020000   1.300     
1.000   

11000110 11   Apple, sauce                       0.020000   1.000     
1.000   

11000111 11   Apple, sauce-babyfood              0.020000   1.000     
1.000   

12000120 12   Apricot                            0.020000   1.000     
1.000   

12000121 12   Apricot-babyfood                   0.020000   1.000     
1.000   

12000130 12   Apricot, dried                     0.020000   6.000     
1.000   

12000140 12   Apricot, juice                     0.020000   1.000     
1.000   

12000141 12   Apricot, juice-babyfood            0.020000   1.000     
1.000   

01030150 1CD  Arrowroot, flour                   0.020000   1.000     
1.000   May 2004 new uses

01030151 1CD  Arrowroot, flour-babyfood          0.020000   1.000     
1.000   May 2004 new uses

01030170 1CD  Artichoke, Jerusalem               0.020000   1.000     
1.000   May 2004 new uses

95000190 O    Asparagus                          0.020000   1.000     
1.000   July 2007 PP#6F7092 and 6E7151

06030300 6C   Bean, black, seed                  0.050000   1.000     
1.000   July 2007 PP#6F7092 and 6E7151

06030320 6C   Bean, broad, seed                  0.050000   1.000     
1.000   July 2007 PP#6F7092 and 6E7151

06030340 6C   Bean, cowpea, seed                 0.050000   1.000     
1.000   July 2007 PP#6F7092 and 6E7151

06030350 6C   Bean,  great northern, seed        0.050000   1.000     
1.000   July 2007 PP#6F7092 and 6E7151

06030380 6C   Bean, lima, seed                   0.050000   1.000     
1.000   July 2007 PP#6F7092 and 6E7151

06030390 6C   Bean, mung, seed                   0.050000   1.000     
1.000   July 2007 PP#6F7092 and 6E7151

06030400 6C   Bean, navy, seed                   0.050000   1.000     
1.000   July 2007 PP#6F7092 and 6E7151

06030410 6C   Bean, pink, seed                   0.050000   1.000     
1.000   July 2007 PP#6F7092 and 6E7151

06030420 6C   Bean, pinto, seed                  0.050000   1.000     
1.000   July 2007 PP#6F7092 and 6E7151

13020570 13B  Blueberry                          0.020000   1.000     
1.000   July 2007 PP#6F7092 and 6E7151

13020571 13B  Blueberry-babyfood                 0.020000   1.000     
1.000   July 2007 PP#6F7092 and 6E7151

14000590 14   Brazil nut                         0.020000   1.000     
1.000   July 2007 PP#6F7092 and 6E7151

14000680 14   Butternut                          0.020000   1.000     
1.000   July 2007 PP#6F7092 and 6E7151

09010750 9A   Cantaloupe                         0.020000   1.000     
1.000   July 2007 PP#6F7092 and 6E7151

09010800 9A   Casaba                             0.020000   1.000     
1.000   July 2007 PP#6F7092 and 6E7151

14000810 14   Cashew                             0.020000   1.000     
1.000   July 2007 PP#6F7092 and 6E7151

01030820 1CD  Cassava                            0.020000   1.000     
1.000   May 2004 new uses

01030821 1CD  Cassava-babyfood                   0.020000   1.000     
1.000   May 2004 new uses

12000900 12   Cherry                             0.020000   1.000     
1.000   

12000901 12   Cherry-babyfood                    0.020000   1.000     
1.000   

12000910 12   Cherry, juice                      0.020000   1.500     
1.000   

12000911 12   Cherry, juice-babyfood             0.020000   1.500     
1.000   

14000920 14   Chestnut                           0.020000   1.000     
1.000   July 2007 PP#6F7092 and 6E7151

95001280 O    Cottonseed, oil                    0.020000   1.000     
1.000   

95001281 O    Cottonseed, oil-babyfood           0.020000   1.000     
1.000   

11001290 11   Crabapple                          0.020000   1.000     
1.000   

13021360 13B  Currant                            0.020000   1.000     
1.000   July 2007 PP#6F7092 and 6E7151

13021370 13B  Currant, dried                     0.020000   1.000     
1.000   July 2007 PP#6F7092 and 6E7151

01031390 1CD  Dasheen, corm                      0.020000   1.000     
1.000   May 2004 new uses

08001480 8    Eggplant                           0.020000   1.000     
1.000   July 2007 PP#6F7092 and 6E7151

13021490 13B  Elderberry                         0.020000   1.000     
1.000   July 2007 PP#6F7092 and 6E7151

14001550 14   Filbert                            0.020000   1.000     
1.000   July 2007 PP#6F7092 and 6E7151

14001560 14   Filbert, oil                       0.020000   1.000     
1.000   July 2007 PP#6F7092 and 6E7151

03001640 3    Garlic                             0.020000   1.000     
1.000   May 2004 new uses

03001650 3    Garlic, dried                      0.020000   9.000     
1.000   May 2004 new uses

03001651 3    Garlic, dried-babyfood             0.020000   9.000     
1.000   May 2004 new uses

01031660 1CD  Ginger                             0.020000   1.000     
1.000   May 2004 new uses

01031661 1CD  Ginger-babyfood                    0.020000   1.000     
1.000   May 2004 new uses

01031670 1CD  Ginger, dried                      0.020000   1.000     
1.000   May 2004 new uses

13021740 13B  Gooseberry                         0.020000   1.000     
1.000   July 2007 PP#6F7092 and 6E7151

95001750 O    Grape                              0.020000   1.000     
1.000   May 2004 new uses

95001760 O    Grape, juice                       0.020000   1.200     
1.000   May 2004 new uses

95001761 O    Grape, juice-babyfood              0.020000   1.200     
1.000   May 2004 new uses

95001770 O    Grape, leaves                      0.020000   1.000     
1.000   May 2004 new uses

95001780 O    Grape, raisin                      0.020000   4.300     
1.000   May 2004 new uses

95001790 O    Grape, wine and sherry             0.020000   1.000     
1.000   May 2004 new uses

14001850 14   Hickory nut                        0.020000   1.000     
1.000   July 2007 PP#6F7092 and 6E7151

09011870 9A   Honeydew melon                     0.020000   1.000     
1.000   July 2007 PP#6F7092 and 6E7151

13021910 13B  Huckleberry                        0.020000   1.000     
1.000   July 2007 PP#6F7092 and 6E7151

11002100 11   Loquat                             0.020000   1.000     
1.000   

14002130 14   Macadamia nut                      0.020000   1.000     
1.000   July 2007 PP#6F7092 and 6E7151

12002300 12   Nectarine                          0.020000   1.000     
1.000   

08002340 8    Okra                               0.020000   1.000     
1.000   July 2007 PP#6F7092 and 6E7151

03002370 3    Onion, dry bulb                    0.020000   1.000     
1.000   May 2004 new uses

03002371 3    Onion, dry bulb-babyfood           0.020000   1.000     
1.000   May 2004 new uses

03002380 3    Onion, dry bulb, dried             0.020000   9.000     
1.000   May 2004 new uses

03002381 3    Onion, dry bulb, dried-babyfood    0.020000   9.000     
1.000   May 2004 new uses

12002600 12   Peach                              0.020000   1.000     
1.000   

12002601 12   Peach-babyfood                     0.020000   1.000     
1.000   

12002610 12   Peach, dried                       0.020000   7.000     
1.000   

12002611 12   Peach, dried-babyfood              0.020000   7.000     
1.000   

12002620 12   Peach, juice                       0.020000   1.000     
1.000   

12002621 12   Peach, juice-babyfood              0.020000   1.000     
1.000   

95002630 O    Peanut                             0.020000   1.000     
1.000   

95002640 O    Peanut, butter                     0.020000   1.890     
1.000   

95002650 O    Peanut, oil                        0.020000   1.000     
1.000   

11002660 11   Pear                               0.020000   1.000     
1.000   

11002661 11   Pear-babyfood                      0.020000   1.000     
1.000   

11002670 11   Pear, dried                        0.020000   6.250     
1.000   

11002680 11   Pear, juice                        0.020000   1.000     
1.000   

11002681 11   Pear, juice-babyfood               0.020000   1.000     
1.000   

14002690 14   Pecan                              0.020000   1.000     
1.000   July 2007 PP#6F7092 and 6E7151

08002700 8    Pepper, bell                       0.020000   1.000     
1.000   July 2007 PP#6F7092 and 6E7151

08002701 8    Pepper, bell-babyfood              0.020000   1.000     
1.000   July 2007 PP#6F7092 and 6E7151

08002710 8    Pepper, bell, dried                0.020000   1.000     
1.000   July 2007 PP#6F7092 and 6E7151

08002711 8    Pepper, bell, dried-babyfood       0.020000   1.000     
1.000   July 2007 PP#6F7092 and 6E7151

08002720 8    Pepper, nonbell                    0.020000   1.000     
1.000   July 2007 PP#6F7092 and 6E7151

08002721 8    Pepper, nonbell-babyfood           0.020000   1.000     
1.000   July 2007 PP#6F7092 and 6E7151

08002730 8    Pepper, nonbell, dried             0.020000   1.000     
1.000   July 2007 PP#6F7092 and 6E7151

95002750 O    Peppermint                         0.040000   1.000     
1.000   May 2004 new uses

95002760 O    Peppermint, oil                    0.040000   1.000     
1.000   May 2004 new uses

14002820 14   Pistachio                          0.020000   1.000     
1.000   May 2004 new uses

12002850 12   Plum                               0.020000   1.000     
1.000   

12002851 12   Plum-babyfood                      0.020000   1.000     
1.000   

12002860 12   Plum, prune, fresh                 0.020000   1.000     
1.000   

12002861 12   Plum, prune, fresh-babyfood        0.020000   1.000     
1.000   

12002870 12   Plum, prune, dried                 0.020000   5.000     
1.000   

12002871 12   Plum, prune, dried-babyfood        0.020000   5.000     
1.000   

12002880 12   Plum, prune, juice                 0.020000   1.400     
1.000   

12002881 12   Plum, prune, juice-babyfood        0.020000   1.400     
1.000   

01032960 1C   Potato, chips                      0.020000   1.000     
1.000   May 2004 new uses

01032970 1C   Potato, dry (granules/ flakes)     0.020000   6.500     
1.000   May 2004 new uses

01032971 1C   Potato, dry (granules/ flakes)-b   0.020000   6.500     
1.000   May 2004 new uses

01032980 1C   Potato, flour                      0.020000   6.500     
1.000   May 2004 new uses

01032981 1C   Potato, flour-babyfood             0.020000   6.500     
1.000   May 2004 new uses

01032990 1C   Potato, tuber, w/peel              0.020000   1.000     
1.000   May 2004 new uses

01032991 1C   Potato, tuber, w/peel-babyfood     0.020000   1.000     
1.000   May 2004 new uses

01033000 1C   Potato, tuber, w/o peel            0.020000   1.000     
1.000   May 2004 new uses

01033001 1C   Potato, tuber, w/o peel-babyfood   0.020000   1.000     
1.000   May 2004 new uses

09023080 9B   Pumpkin                            0.020000   1.000     
1.000   Section 18 Aug. 2006 PP#06IL04

09023090 9B   Pumpkin, seed                      0.020000   1.000     
1.000   Section 18 Aug. 2006 PP#06IL04

11003100 11   Quince                             0.020000   1.000     
1.000   

03003380 3    Shallot                            0.020000   1.000     
1.000   May 2004 new uses

06003470 6    Soybean, seed                      0.020000   1.000     
1.000   

06003480 6    Soybean, flour                     0.020000   1.000     
1.000   

06003481 6    Soybean, flour-babyfood            0.020000   1.000     
1.000   

06003490 6    Soybean, soy milk                  0.020000   1.000     
1.000   

06003491 6    Soybean, soy milk-babyfood or in   0.020000   1.000     
1.000   

06003500 6    Soybean, oil                       0.020000   1.000     
1.000   

06003501 6    Soybean, oil-babyfood              0.020000   1.000     
1.000   

95003520 O    Spearmint                          0.040000   1.000     
1.000   May 2004 new uses

95003530 O    Spearmint, oil                     0.040000   1.000     
1.000   May 2004 new uses

95003590 O    Strawberry                         0.070000   1.000     
1.000   

95003591 O    Strawberry-babyfood                0.070000   1.000     
1.000   

95003600 O    Strawberry, juice                  0.070000   1.000     
1.000   

95003601 O    Strawberry, juice-babyfood         0.070000   1.000     
1.000   

95003620 O    Sugarcane, sugar                   0.200000   1.000     
1.000   May 2004 new uses

95003621 O    Sugarcane, sugar-babyfood          0.200000   1.000     
1.000   May 2004 new uses

95003630 O    Sugarcane, molasses                0.200000   1.000     
1.000   May 2004 new uses

95003631 O    Sugarcane, molasses-babyfood       0.200000   1.000     
1.000   May 2004 new uses

01033660 1CD  Sweet potato                       0.020000   1.000     
1.000   

01033661 1CD  Sweet potato-babyfood              0.020000   1.000     
1.000   

01033710 1CD  Tanier, corm                       0.020000   1.000     
1.000   May 2004 new uses

08003740 8    Tomatillo                          0.020000   1.000     
1.000   July 2007 PP#6F7092 and 6E7151

08003750 8    Tomato                             0.020000   1.000     
1.000   July 2007 PP#6F7092 and 6E7151

08003751 8    Tomato-babyfood                    0.020000   1.000     
1.000   July 2007 PP#6F7092 and 6E7151

08003760 8    Tomato, paste                      0.020000   1.000     
1.000   July 2007 PP#6F7092 and 6E7151

08003761 8    Tomato, paste-babyfood             0.020000   1.000     
1.000   July 2007 PP#6F7092 and 6E7151

08003770 8    Tomato, puree                      0.020000   1.000     
1.000   July 2007 PP#6F7092 and 6E7151

08003771 8    Tomato, puree-babyfood             0.020000   1.000     
1.000   July 2007 PP#6F7092 and 6E7151

08003780 8    Tomato, dried                      0.020000   1.000     
1.000   July 2007 PP#6F7092 and 6E7151

08003781 8    Tomato, dried-babyfood             0.020000   1.000     
1.000   July 2007 PP#6F7092 and 6E7151

08003790 8    Tomato, juice                      0.020000   1.000     
1.000   July 2007 PP#6F7092 and 6E7151

01033870 1CD  Turmeric                           0.020000   1.000     
1.000   May 2004 new uses

14003910 14   Walnut                             0.020000   1.000     
1.000   July 2007 PP#6F7092 and 6E7151

86010000 O    Water, direct, all sources         0.048000   1.000     
1.000   

86020000 O    Water, indirect, all sources       0.048000   1.000     
1.000   

09013990 9A   Watermelon                         0.020000   1.000     
1.000   July 2007 PP#6F7092 and 6E7151

09014000 9A   Watermelon, juice                  0.020000   1.000     
1.000   July 2007 PP#6F7092 and 6E7151

01034060 1CD  Yam, true                          0.020000   1.000     
1.000   

01034070 1CD  Yam bean                           0.020000   1.000     
1.000   May 2004 new uses

Attachment 2: Results of Acute Dietary Exposure Analysis

U.S. Environmental Protection Agency                                 
Ver. 2.02

DEEM-FCID ACUTE Analysis for FLUMIOXAZIN                        
(1994-98 data)

Residue file: 129034-090607.R98                   Adjustment factor #2
NOT used.

Analysis Date: 09-06-2007/15:04:48    Residue file dated:
09-06-2007/15:02:43/8

NOEL (Acute) =   3.000000 mg/kg body-wt/day

Daily totals for food and foodform consumption used.

Run Comment: ""

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

Summary calculations (per capita):

      95th Percentile             99th Percentile             99.9th
Percentile

 Exposure  % aRfD     MOE    Exposure  % aRfD     MOE    Exposure  %
aRfD     MOE  

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

Females 13-49 yrs:

  0.002524    8.41    1188    0.003965   13.22     756    0.006895  
22.98     435  

Attachment 3: Results of Chronic Dietary Exposure Analysis

U.S. Environmental Protection Agency                                
Ver. 2.00

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

Residue file name: E:\ARIA-Flumioxazin\DEEM\129034-090607.R98

                                                 Adjustment factor #2
NOT used.

Analysis Date 09-06-2007/15:03:24     Residue file dated:
09-06-2007/15:02:43/8

Reference dose (RfD, Chronic) = .02 mg/kg bw/day

NOEL (Chronic) = 2 mg/kg bw/day

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

                    Total exposure by population subgroup

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

                                                    Total Exposure

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

          Population                         mg/kg       Margin of  
Percent 

           Subgroup                       body wt/day   Exposure 1/  of
RfD 

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

U.S. Population (total)                     0.001207        1,658       
6.0%

U.S. Population (spring season)             0.001203        1,663       
6.0%

U.S. Population (summer season)             0.001285        1,557       
6.4%

U.S. Population (autumn season)             0.001170        1,710       
5.8%

U.S. Population (winter season)             0.001168        1,713       
5.8%

Northeast region                            0.001118        1,790       
5.6%

Midwest region                              0.001229        1,627       
6.1%

Southern region                             0.001145        1,747       
5.7%

Western region                              0.001360        1,470       
6.8%

Hispanics                                   0.001356        1,475       
6.8%

Non-hispanic whites                         0.001181        1,693       
5.9%

Non-hispanic blacks                         0.001149        1,741       
5.7%

Non-hisp/non-white/non-black                0.001435        1,393       
7.2%

All infants (< 1 year)                      0.003689          542      
18.4%

Nursing infants                             0.001416        1,412       
7.1%

Non-nursing infants                         0.004552          439      
22.8%

Children 1-6  yrs                           0.001985        1,008       
9.9%

Children 7-12 yrs                           0.001227        1,630       
6.1%

Females 13-19 (not preg or nursing)         0.000873        2,290       
4.4%

Females 20+ (not preg or nursing)           0.001136        1,760       
5.7%

Females 13-50 yrs                           0.001128        1,774       
5.6%

Females 13+ (preg/not nursing)              0.001163        1,719       
5.8%

Females 13+ (nursing)                       0.001589        1,259       
7.9%

Males 13-19 yrs                             0.000921        2,172       
4.6%

Males 20+ yrs                               0.001039        1,925       
5.2%

Seniors 55+                                 0.001122        1,782       
5.6%

Children 1-2 yrs                            0.002168          923      
10.8%

Children 3-5 yrs                            0.001958        1,021       
9.8%

Children 6-12 yrs                           0.001299        1,540       
6.5%

Youth 13-19 yrs                             0.000900        2,221       
4.5%

Adults 20-49 yrs                            0.001076        1,858       
5.4%

Adults 50+ yrs                              0.001121        1,783       
5.6%

Females 13-49 yrs                           0.001076        1,858       
5.4%

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



Attachment 4:  Chemical Structure of Flumioxazin and metabolites (482-HA
and APF) used in the EDWCs.

Chemical Name	Structure

Flumioxazin

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

482-HA

N-[7-fluoro-3-oxo-4-(2-propynyl)- 2H-1,4-benzoxazin-6-yl]-3,4,5,6-
tetrahydrophthalamic acid

APF

6-amino-7-fluoro-4-(2-propenyl)- 2H-1,4-benzoxazin-3(4H)-one

	

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ഀFlumioxazin	Dietary Exposure Assessment	DP Num:	342753

PC Code: 129034		Page:   PAGE  14  of   NUMPAGES  14