Document ID: EPA-HQ-OPP-2008-0885-0006
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2010-02-24T05:00Z

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, D.C.  20460

OFFICE OF

 PREVENTION, PESTICIDES

AND TOXIC SUBSTANCES

MEMORANDUM

DATE:  	8/11/09 

SUBJECT:	Flumioxazin.  Acute and Chronic Dietary (Food and Water)
Exposure Assessments for the Petition Proposing Tolerances for Residues
of Flumioxazin on Fish, Cucurbit Vegetables, Leaf Petioles, and Hops.  

Petition #	8F7438 & 8E7462	Decision Number:	402046

DP Number:	367978	MRID No.:	NA

PC Code:	129034	Chemical Class:	N-phenylpthalimide derivative herbicide

40 CFR 180.	568	CAS No.:  	103361-09-7

Regulatory Action:	Section 3 Registration	EPA Reg. No.:  	Clipper(
Herbicide (59639-161), Valor™ Herbicide (59639-99), and Chateau™
Herbicide (59639-119)

REVIEWER:	W. Cutchin, Acting Senior Branch Scientist 

Alternative Risk Integration and Assessment (ARIA) Team

Risk Integration Minor Use and Emergency Response Branch 			
(RIMUERB)/Registration Division (RD; 7505P)

THROUGH:	D. Rate, Biologist

D. Hrdy, Biologist

DESAC

Health Effects Division (HED; 7505P)

TO:		W. Cutchin, Acting Senior Branch Scientist 

ARIA Team

RIMUERB/RD (7505P)

	and

	J. Miller/ D. Rosenblatt

	RIMUERB/RD (7505P)

Executive Summary

The purpose of this memorandum is to report the results of a dietary
(food + drinking water) exposure analysis for the herbicide 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.

D™, Version 2.03) which uses food consumption data from the U.S.
Department of Agriculture’s Continuing Surveys of Food Intakes by
Individuals (CSFII) from 1994-1996 and 1998.  These analyses were
performed to support a Section 3 requests (PP#s: 8F7438 & 8E7462) to
establish tolerances for residues of flumioxazin on fish, cucurbit
vegetables, leaf petioles, and hops.

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.

Both the acute and chronic exposure analyses were performed assuming
tolerance-level residues of flumioxazin for all commodities with
existing and ARIA recommended tolerances, empirical processing factors
obtained from processing studies (tomatoes) along with DEEM 7.81 default
processing factors for the remaining processed commodities, 100% crop
treated (CT) and an estimated drinking water concentration (EDWC) of
0.048 ppm for flumioxazin.  

 Acute Dietary (Food + Drinking Water) Exposure Results and
Characterization

There were no appropriate toxicological effects attributable to a single
exposure (dose) for the general population or any other population
subgroups except females 13-49 years old; therefore, these population
subgroups were not included in this assessment.  An acute dietary
assessment was conducted only for the population subgroup females 13-49
years old.  For food and drinking water, the exposure to females 13-49
years old utilized 9% of the aPAD at the 95th percentile of exposure
distribution.  The acute dietary risk assessment for flumioxazin shows
that for all included commodities, the acute dietary risk estimates are
below ARIA’s level of concern (i.e. <100% aPAD).  

Chronic Dietary (Food + Drinking Water) Exposure Results and
Characterization

A chronic dietary assessment was conducted for the general U.S.
population and all population subgroups.  For the general U.S.
population the exposure for food and drinking water utilized 7% of the
cPAD.  The chronic dietary risk estimate for the highest reported
exposed population subgroup, all infants (<1 year old), is 19% of the
cPAD.

The chronic dietary risk assessment shows that for all included
commodities, the chronic dietary risk estimates are below ARIA’s level
of concern (i.e. <100% chronic population adjusted doses (cPAD).  

Cancer Exposure Results and Characterization

Flumioxazin was classified as “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; therefore, no
cancer assessment was performed.

I.	Introduction

Dietary risk assessment incorporates both exposure and toxicity of a
given pesticide.  For acute and chronic assessments, the risk is
expressed as a percentage of a maximum acceptable dose (i.e., the dose
which ARIA 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 (i.e.,
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,” 6/21/2000, web link:     
HYPERLINK
"http://www.epa.gov/fedrgstr/EPA-PEST/2000/July/Day-12/6061.pdf" 
http://www.epa.gov/fedrgstr/EPA-PEST/2000/July/Day-12/6061.pdf  ; or see
SOP 99.6 (8/20/99).

The most recent dietary risk assessment for flumioxazin was conducted by
B. Hanson (PP#7F7243, DP#: 342414, 3/5/08).

II.	Residue Information

Tolerances:  Tolerances are currently established for residues of the
herbicide flumioxazin in/on various plant commodities, at levels ranging
from 0.02 to 8.0 ppm (as listed in e-CFR 40 §180.568[a], Updated June
1, 2009).  

Residue of Concern:  The residue of concern for both the tolerance
expression and risk assessment in plants is flumioxazin per se.  The
residue of concern for both the tolerance expression and risk assessment
in fish is flumioxazin and its metabolites APF
(3-oxo-4-prop-2ynyl-6-amino-7-fluoro-3,4-dihydro-1,4-benzoxazin) and
482-HA
(N-(7-fluoro-3,4-dihdyro-3-oxo-4-prop-2-ynyl-2H-1,4-benzoxazin-6-yl)cycl
ohex-1-ene-1-carboxamide-2-carboxylic acid), each expressed as parent
equivalents.

Residue Data Used for Dietary Assessments:  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.

Current and ARIA recommended tolerance-level residues were used for all
raw agricultural commodities (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.  A tomato processing factor
of 1 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, 6/19/07).  100%CT was assumed for all
commodities in this assessment.  

As part of the current petition, ARIA recommends establishing
tolerances: 

Fish, fresh water	1.5 ppm

Cucurbit vegetables group 9	0.03 ppm

Leaf petioles subgroup 4B	0.02 ppm

Hops, dried cones	0.05 ppm

Because the aquatic applications of flumioxazin are prohibited to
flowing water, intertidal or estuarine areas and to water used for
crawfish farming, residue data and tolerances are not required for
shellfish or saltwater fishes.

III.	Drinking Water Data

The drinking water residues used in the dietary risk assessment were
provided by EFED in the following memorandum: “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#: D336195, 342249,
331732; L. Liu; 9/25/07) and incorporated directly into this dietary
assessment.  Water residues were incorporated in the DEEM-FCID into the
food categories “water, direct, all sources” and “water, indirect,
all sources.” 

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 flumioxazin (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 Screening Concentration In GroundWater (SCI-GROW) model. 
SCI-GROW 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 7.1

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

1 Total EDWC = Flumioxazin + 482-HA + APF

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

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.”  

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.  

Results of Acute Dietary Exposure Analysis

Flumioxazin acute dietary (food + water) exposure estimates using the
DEEM-FCID™ software are below ARIA’s level of concern for females
13-49.  The acute dietary exposure for the females, 13-49 years old,
utilized 9% of the aPAD.

Results of Chronic Dietary Exposure Analysis

Flumioxazin chronic dietary (food + water) exposure estimates using the
DEEM-FCID™ software are below ARIA’s level of concern for the U.S.
population and each of the population subgroups.  Chronic dietary
exposure utilized 7% of the cPAD for the U.S. population.  The chronic
dietary exposure for the highest reported exposed population subgroup,
all infants (<1 year old), was 19% of the cPAD.

The results of the acute and chronic dietary exposure analyses are
reported in the Summary Table (Table 3, below).

TABLE 3.  Summary of Dietary Exposure and Risk for Flumioxazin.  

Population Subgroup1	

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 U.S. Population	

NA 2	0.02	0.001307	7

All Infants (< 1 year old)

0.02	0.003761	19

Children 1-2 years old

0.02	0.002289	11

Children 3-5 years old

0.02	0.002120	11

Children 6-12 years old

0.02	0.001433	7

Youth 13-19 years old

0.02	0.000980	5

Adults 20-49 years old

0.02	0.001165	6

Adults 50+ years old

0.02	0.001225	6

Females 13-49 years old	0.03	0.002734	9	0.02	0.001165	6

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.  Although not
needed at this time, the analyses could be further refined through the
use of average residues based on field trial data, percent crop treated
data and/or preparation/cooking factors.  Since risk estimates are below
ARIA’s level of concern, a more highly refined analysis is not needed
at this time.

VIII.	Conclusions

Based on conservative assumptions, dietary risk estimates for
flumioxazin do not exceed ARIA’s level of concern for the general U.S.
population, nor did any of the population subgroups, including those
comprised of infants and children.  For the acute analysis, there were
no differences between user vs. per capita exposure and risk.

IX.	List of Attachments

Attachment 1:  Food plus Water Residue Input File

Attachment 2:  Acute Results File

Attachment 3:  Chronic Results File

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

Attachment 1:  Food plus Water Residue Input File

U.S. Environmental Protection Agency                                
Ver. 2.00

DEEM-FCID Chronic analysis for FLUMIOXAZIN                       
1994-98 data

Residue file: G:\129034c.r98                               Adjust. #2
NOT used

Analysis Date 06-04-2009             Residue file dated:
06-04-2009/10:40:15/8

Reference dose (RfD) = 0.02 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   

14000031 14   Almond-babyfood                    0.020000   1.000     
1.000   

14000040 14   Almond, oil                        0.020000   1.000     
1.000   

14000041 14   Almond, oil-babyfood               0.020000   1.000     
1.000   

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   

01030151 1CD  Arrowroot, flour-babyfood          0.020000   1.000     
1.000   

01030170 1CD  Artichoke, Jerusalem               0.020000   1.000     
1.000   

95000190 O    Asparagus                          0.020000   1.000     
1.000   

09020210 9B   Balsam pear                        0.030000   1.000     
1.000   

06030300 6C   Bean, black, seed                  0.050000   1.000     
1.000   

06030320 6C   Bean, broad, seed                  0.050000   1.000     
1.000   

06030340 6C   Bean, cowpea, seed                 0.050000   1.000     
1.000   

06030350 6C   Bean,  great northern, seed        0.050000   1.000     
1.000   

06030360 6C   Bean, kidney, seed                 0.050000   1.000     
1.000   

06030380 6C   Bean, lima, seed                   0.050000   1.000     
1.000   

06030390 6C   Bean, mung, seed                   0.050000   1.000     
1.000   

06030400 6C   Bean, navy, seed                   0.050000   1.000     
1.000   

06030410 6C   Bean, pink, seed                   0.050000   1.000     
1.000   

06030420 6C   Bean, pinto, seed                  0.050000   1.000     
1.000   

13020570 13B  Blueberry                          0.020000   1.000     
1.000   

13020571 13B  Blueberry-babyfood                 0.020000   1.000     
1.000   

14000590 14   Brazil nut                         0.020000   1.000     
1.000   

14000680 14   Butternut                          0.020000   1.000     
1.000   

09010750 9A   Cantaloupe                         0.030000   1.000     
1.000   

04020760 4B   Cardoon                            0.020000   1.000     
1.000   

09010800 9A   Casaba                             0.030000   1.000     
1.000   

14000810 14   Cashew                             0.020000   1.000     
1.000   

01030820 1CD  Cassava                            0.020000   1.000     
1.000   

01030821 1CD  Cassava-babyfood                   0.020000   1.000     
1.000   

04020850 4B   Celery                             0.020000   1.000     
1.000   

04020851 4B   Celery-babyfood                    0.020000   1.000     
1.000   

04020860 4B   Celery, juice                      0.020000   1.000     
1.000   

04020870 4B   Celtuce                            0.020000   1.000     
1.000   

09020880 9B   Chayote, fruit                     0.030000   1.000     
1.000   

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   

09021020 9B   Chinese waxgourd                   0.030000   1.000     
1.000   

15001200 15   Corn, field, flour                 0.020000   1.000     
1.000   

15001201 15   Corn, field, flour-babyfood        0.020000   1.000     
1.000   

15001210 15   Corn, field, meal                  0.020000   1.000     
1.000   

15001211 15   Corn, field, meal-babyfood         0.020000   1.000     
1.000   

15001220 15   Corn, field, bran                  0.020000   1.000     
1.000   

15001230 15   Corn, field, starch                0.020000   1.000     
1.000   

15001231 15   Corn, field, starch-babyfood       0.020000   1.000     
1.000   

15001240 15   Corn, field, syrup                 0.020000   1.500     
1.000   

15001241 15   Corn, field, syrup-babyfood        0.020000   1.500     
1.000   

15001250 15   Corn, field, oil                   0.020000   1.000     
1.000   

15001251 15   Corn, field, oil-babyfood          0.020000   1.000     
1.000   

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   

95001300 O    Cranberry                          0.020000   1.000     
1.000   

95001301 O    Cranberry-babyfood                 0.020000   1.000     
1.000   

95001310 O    Cranberry, dried                   0.020000   1.000     
1.000   

95001320 O    Cranberry, juice                   0.020000   1.100     
1.000   

95001321 O    Cranberry, juice-babyfood          0.020000   1.100     
1.000   

09021350 9B   Cucumber                           0.030000   1.000     
1.000   

13021360 13B  Currant                            0.020000   1.000     
1.000   

13021370 13B  Currant, dried                     0.020000   1.000     
1.000   

01031390 1CD  Dasheen, corm                      0.020000   1.000     
1.000   

08001480 8    Eggplant                           0.020000   1.000     
1.000   

13021490 13B  Elderberry                         0.020000   1.000     
1.000   

04021520 4B   Fennel, Florence                   0.020000   1.000     
1.000   

14001550 14   Filbert                            0.020000   1.000     
1.000   

14001560 14   Filbert, oil                       0.020000   1.000     
1.000   

80001570 F    Fish-freshwater finfish            1.500000   1.000     
1.000   

80001580 F    Fish-freshwater finfish, farm ra   1.500000   1.000     
1.000   

03001640 3    Garlic                             0.020000   1.000     
1.000   

03001650 3    Garlic, dried                      0.020000   1.000     
1.000   

03001651 3    Garlic, dried-babyfood             0.020000   1.000     
1.000   

01031660 1CD  Ginger                             0.020000   1.000     
1.000   

01031661 1CD  Ginger-babyfood                    0.020000   1.000     
1.000   

01031670 1CD  Ginger, dried                      0.020000   1.000     
1.000   

13021740 13B  Gooseberry                         0.020000   1.000     
1.000   

95001750 O    Grape                              0.020000   1.000     
1.000   

95001760 O    Grape, juice                       0.020000   1.200     
1.000   

95001761 O    Grape, juice-babyfood              0.020000   1.200     
1.000   

95001770 O    Grape, leaves                      0.020000   1.000     
1.000   

95001780 O    Grape, raisin                      0.020000   4.300     
1.000   

95001790 O    Grape, wine and sherry             0.020000   1.000     
1.000   

14001850 14   Hickory nut                        0.020000   1.000     
1.000   

09011870 9A   Honeydew melon                     0.030000   1.000     
1.000   

95001880 O    Hop                                0.050000   1.000     
1.000   

13021910 13B  Huckleberry                        0.020000   1.000     
1.000   

11002100 11   Loquat                             0.020000   1.000     
1.000   

14002130 14   Macadamia nut                      0.020000   1.000     
1.000   

12002300 12   Nectarine                          0.020000   1.000     
1.000   

08002340 8    Okra                               0.020000   1.000     
1.000   

03002370 3    Onion, dry bulb                    0.020000   1.000     
1.000   

03002371 3    Onion, dry bulb-babyfood           0.020000   1.000     
1.000   

03002380 3    Onion, dry bulb, dried             0.020000   9.000     
1.000   

03002381 3    Onion, dry bulb, dried-babyfood    0.020000   9.000     
1.000   

03002390 3    Onion, green                       0.020000   1.000     
1.000   

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   

08002700 8    Pepper, bell                       0.020000   1.000     
1.000   

08002701 8    Pepper, bell-babyfood              0.020000   1.000     
1.000   

08002710 8    Pepper, bell, dried                0.020000   1.000     
1.000   

08002711 8    Pepper, bell, dried-babyfood       0.020000   1.000     
1.000   

08002720 8    Pepper, nonbell                    0.020000   1.000     
1.000   

08002721 8    Pepper, nonbell-babyfood           0.020000   1.000     
1.000   

08002730 8    Pepper, nonbell, dried             0.020000   1.000     
1.000   

95002750 O    Peppermint                         0.040000   1.000     
1.000   

14002820 14   Pistachio                          0.020000   1.000     
1.000   

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   

01032970 1C   Potato, dry (granules/ flakes)     0.020000   6.500     
1.000   

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

01032980 1C   Potato, flour                      0.020000   6.500     
1.000   

01032981 1C   Potato, flour-babyfood             0.020000   6.500     
1.000   

01032990 1C   Potato, tuber, w/peel              0.020000   1.000     
1.000   

01032991 1C   Potato, tuber, w/peel-babyfood     0.020000   1.000     
1.000   

01033000 1C   Potato, tuber, w/o peel            0.020000   1.000     
1.000   

01033001 1C   Potato, tuber, w/o peel-babyfood   0.020000   1.000     
1.000   

09023080 9B   Pumpkin                            0.030000   1.000     
1.000   

09023090 9B   Pumpkin, seed                      0.030000   1.000     
1.000   

11003100 11   Quince                             0.020000   1.000     
1.000   

04023220 4B   Rhubarb                            0.020000   1.000     
1.000   

03003380 3    Shallot                            0.020000   1.000     
1.000   

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   

09023560 9B   Squash, summer                     0.030000   1.000     
1.000   

09023561 9B   Squash, summer-babyfood            0.030000   1.000     
1.000   

09023570 9B   Squash, winter                     0.030000   1.000     
1.000   

09023571 9B   Squash, winter-babyfood            0.030000   1.000     
1.000   

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   

95003621 O    Sugarcane, sugar-babyfood          0.200000   1.000     
1.000   

95003630 O    Sugarcane, molasses                0.200000   1.000     
1.000   

95003631 O    Sugarcane, molasses-babyfood       0.200000   1.000     
1.000   

01033660 1CD  Sweet potato                       0.020000   1.000     
1.000   

01033661 1CD  Sweet potato-babyfood              0.020000   1.000     
1.000   

04023670 4B   Swiss chard                        0.020000   1.000     
1.000   

01033710 1CD  Tanier, corm                       0.020000   1.000     
1.000   

08003740 8    Tomatillo                          0.020000   1.000     
1.000   

08003750 8    Tomato                             0.020000   1.000     
1.000   

08003751 8    Tomato-babyfood                    0.020000   1.000     
1.000   

08003760 8    Tomato, paste                      0.020000   1.000     
1.000   

08003761 8    Tomato, paste-babyfood             0.020000   1.000     
1.000   

08003770 8    Tomato, puree                      0.020000   1.000     
1.000   

08003771 8    Tomato, puree-babyfood             0.020000   1.000     
1.000   

08003780 8    Tomato, dried                      0.020000   1.000     
1.000   

08003781 8    Tomato, dried-babyfood             0.020000   1.000     
1.000   

08003790 8    Tomato, juice                      0.020000   1.000     
1.000   

01033870 1CD  Turmeric                           0.020000   1.000     
1.000   

14003910 14   Walnut                             0.020000   1.000     
1.000   

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                         0.030000   1.000     
1.000   

09014000 9A   Watermelon, juice                  0.030000   1.000     
1.000   

01034060 1CD  Yam, true                          0.020000   1.000     
1.000   

01034070 1CD  Yam bean                           0.020000   1.000     
1.000   

Attachment 2:  Acute Results File

U.S. Environmental Protection Agency                                 
Ver. 2.02

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

Residue file: 129034c.r98                         Adjustment factor #2
NOT used.

Analysis Date: 06-04-2009/11:46:48    Residue file dated:
06-04-2009/10:40:15/8

Daily totals for food and foodform consumption used.

Run Comment: ""

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

Summary calculations (per capita):

                    95th Percentile      99th Percentile      99.9th
Percentile

                   Exposure   % aRfD    Exposure   % aRfD    Exposure  
% aRfD 

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

Females 13-49 yrs:

                    0.002734     9.11    0.004778    15.93    0.009800  
 32.67 

U.S. Environmental Protection Agency                                 
Ver. 2.02

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

Residue file: 129034c.r98                         Adjustment factor #2
NOT used.

Analysis Date: 06-04-2009/11:46:48    Residue file dated:
06-04-2009/10:40:15/8

Acute Reference Dose (aRfD) =   0.030000 mg/kg body-wt/day

Daily totals for food and foodform consumption used.

Run Comment: ""

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

Females 13-49 yrs                  Daily Exposure Analysis  /a

-----------------                  (mg/kg body-weight/day) 

                                    per Capita    per User 

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

            Mean                      0.001165     0.001165

            Standard Deviation        0.000950     0.000950

            Standard Error of mean    0.000012     0.000012

            Percent of aRfD               3.88         3.88

       Percent of Person-Days that are User-Days =  99.99%

 

Attachment 3:  Chronic Results File

U.S. Environmental Protection Agency                                
Ver. 2.00

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

Residue file name: G:\129034c.r98                Adjustment factor #2
NOT used.

Analysis Date 06-04-2009/11:44:53     Residue file dated:
06-04-2009/10:40:15/8

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

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

                    Total exposure by population subgroup

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

                                                    Total Exposure

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

          Population                         mg/kg             Percent
of   

           Subgroup                       body wt/day             Rfd   
   

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

U.S. Population (total)                     0.001307                
6.5%

U.S. Population (spring season)             0.001306                
6.5%

U.S. Population (summer season)             0.001393                
7.0%

U.S. Population (autumn season)             0.001271                
6.4%

U.S. Population (winter season)             0.001255                
6.3%

Northeast region                            0.001194                
6.0%

Midwest region                              0.001322                
6.6%

Southern region                             0.001251                
6.3%

Western region                              0.001481                
7.4%

Hispanics                                   0.001452                
7.3%

Non-hispanic whites                         0.001271                
6.4%

Non-hispanic blacks                         0.001280                
6.4%

Non-hisp/non-white/non-black                0.001631                
8.2%

All infants (< 1 year)                      0.003761               
18.8%

Nursing infants                             0.001448                
7.2%

Non-nursing infants                         0.004639               
23.2%

Children 1-6  yrs                           0.002130               
10.6%

Children 7-12 yrs                           0.001361                
6.8%

Females 13-19 (not preg or nursing)         0.000944                
4.7%

Females 20+ (not preg or nursing)           0.001229                
6.1%

Females 13-50 yrs                           0.001216                
6.1%

Females 13+ (preg/not nursing)              0.001211                
6.1%

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Females 13+ (nursing)                       0.001684                
8.4%

Males 13-19 yrs                             0.001010                
5.0%

Males 20+ yrs                               0.001135                
5.7%

Seniors 55+                                 0.001229                
6.1%

Children 1-2 yrs                            0.002289               
11.4%

Children 3-5 yrs                            0.002120               
10.6%

Children 6-12 yrs                           0.001433                
7.2%

Youth 13-19 yrs                             0.000980                
4.9%

Adults 20-49 yrs                            0.001165                
5.8%

Adults 50+ yrs                              0.001225                
6.1%

Females 13-49 yrs                           0.001165                
5.8%

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

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

Flumioxazin	Dietary Exposure and Risk Assessment	DP Number: 367978	

PC Code: 129034	

________________________________________________________________________
______________

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