Document ID: EPA-HQ-OPP-2007-0604-0005
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2008-08-27T04:00Z

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, D.C. 20460      

	OFFICE OF PREVENTION, PESTICIDESs

                                                                        
                   AND TOXIC SUBSTANCES

	

MEMORANDUM

Date:  	20/MAY/2008

Subject:	Dichlobenil Acute and Chronic Aggregate Dietary (Food and
Drinking Water) Exposure and Risk Assessments for the Section 3
Registration Action for New Uses on Rhubarb, Caneberry, Subgroup 13-07A,
and Bushberry, Subgroup 13-07B.

PC Code:  027401	DP Barcode:  346388

Decision No.:  380110	Registration No.:  400-168

Petition No.:  7E7230	Regulatory Action:  Section 3

Risk Assessment Type:  Acute and Chronic Aggregate Dietary	Case No.: 
None

TXR No.:  None	CAS No.:  1194-65-6

MRID No.:  None	40 CFR: 180.231 

FROM:	Debra Rate, Ph.D., Biologist

Alternative Risk Integration and Assessment (ARIA) Team 

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

Registration Division (7505P)

THROUGH:	P. Yvonne Barnes, Chemist

Mohsen Sahafeyan, Chemist

Dietary Exposure Science Advisory Council (DESAC)

Health Effects Division (7509P)

and

		William Cutchin, Acting Senior Branch Scientist

		ARIA

		RIMUERB/RD (7505P)

TO:		Debra Rate, Ph.D., Biologist

		ARIA

		RIMUERB/RD (7505P)

and

		Dan Rosenblatt, Branch Chief / Susan Stanton, Environmental Specialist

	RIMUERB/RD (7505P)

Executive Summary

Acute and chronic aggregate dietary (food and drinking water) exposure
and risk assessments were conducted using the Dietary Exposure
Evaluation Model DEEM-FCID™, 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.  The
analyses were performed to support Section 3 requests for uses on
rhubarb, caneberry subgroup (13-07A), and bushberry subgroup (13-07B). 
Dichlobenil is listed as a possible human carcinogen and an RfD approach
should be used for quantification of human cancer risk.  The
quantification of cancer risk using the RfD approach is identical to the
assessment for chronic effects; no separate carcinogenic risk assessment
is necessary. 

The tolerance expression for dichlobenil includes dichlobenil (parent)
and the major metabolite, 2,6-dichlorobenzamide (BAM).  BAM is a
metabolite of two chemicals, fluopicolide and dichlobenil.  BAM and
dichlobenil have been assessed with different toxicological endpoints. 
Residues from drinking water have also been assessed separately for
dichlobenil (parent only) and BAM.  Therefore, this dietary assessment
will refer to dichlobenil (parent only) unless otherwise indicated.  A
separate assessment (DP Num: 340366, N. Dodd, 21/NOV/2007) has been
conducted for the major metabolite, BAM, and was updated (DP Num:
349722, S. Piper, 19/MAR/2008) to include all of the requested berry
commodities.  

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

The acute exposure analysis was performed using the following
assumptions.  As no dichlobenil residues were reported above the lowest
level of method validation (LLMV) on raw agricultural commodities (RACs)
in the submitted studies, these assumptions will result in conservative
estimates of dietary exposure and risk:

Dichlobenil contributions to the recommended or established tolerance
(tolerance level residues minus maximum BAM residues) were used in the
dietary analysis for all existing and proposed RACs (see Table 1);

DEEM 7.81 default processing factors for all processed commodities;

100% crop treated (CT); and

0.298 ppm for the dichlobenil acute estimated drinking water
concentration (EDWC) (DP Num: 322919; J. Angier; 01/NOV/2005).

An acute endpoint was selected for only one population subgroup, females
13-49 years.  Typically, the Agency has concerns regarding dietary risk
when the estimates exceed 100% of the acute population-adjusted dose
(aPAD).  This subgroup had a risk estimate below the Agency’s level of
concern utilizing 33% of the aPAD at the 95th percentile of exposure.

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

The chronic exposure analysis was performed using the following
assumptions.  As discussed above, these assumptions will result in
conservative estimates of dietary exposure and risk:

Dichlobenil contributions to the established or recommended tolerance
(tolerance level residues minus maximum BAM residues) were used in the
dietary analysis for all existing and proposed RACs (see Table 1);

DEEM 7.81 default processing factors for all processed commodities;

100% crop treated (CT); and

0.0046 ppm for the dichlobenil chronic EDWC (DP Num: 322919; J. Angier;
01/NOV/2005).  

Typically, the Agency has concerns regarding dietary risk when the
estimates exceed 100% of the chronic population-adjusted dose (cPAD). 
The dietary risk for the general U.S. population and all population
subgroups were not of concern to the Agency.  The most highly exposed
population subgroup (children 1-2 years) utilizes 30% of the cPAD.  The
general U.S. population utilizes 5% of the cPAD. 

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, the Agency is concerned when
estimated dietary risk exceeds 100% of the PAD.  The Agency 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, 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 (20-AUG-1999).  

The most recent dietary risk assessment for dichlobenil was addressed in
the revised HED chapter of the Reregistration Eligibility Decision (RED)
(July 31, 1996; K. Boyle; Dietary Risk Evaluation System (DRES)).  

II.	Residue Information



Tolerances are established for residues of the herbicide dichlobenil and
BAM in/on various plant commodities, at levels ranging from 0.1 to 0.5
ppm (as listed in 40CFR §180.231[a]).  In conjunction with the proposed
uses, ARIA has recommended in favor of establishing tolerances on
rhubarb, caneberries and bushberries (DP Num: 315266, W. Cutchin,
22/FEB/2006; DP Num: 349398, D. Rate, 12/MAR/2008).  Existing and
recommended tolerances for dichlobenil are listed in Table 1.

Table 1.  Summary of Tolerances and Residue Contribution for Dietary
Analysis from Dichlobenil and BAM.

Commodity	Tolerance (Existing/ Recommended)	Contribution from BAM1
(Dietary Risk)	Contribution from Dichlobenil2 (Dietary Risk)

Apples	0.5	 0.271	 0.229

Cranberry	0.1	0.03	0.07

Grapes	 0.15	0.09	0.06

Fruit, stone, Crop Group 12	 0.53	0.46	0.04

Filbert	0.1	0.02	0.08

Pear	0.5	 0.271	 0.229

Rhubarb	 0.06	0.01	0.05

Caneberry, Subgroup 13-07A	0.1	0.01	0.09

Bushberry, Subgroup 13-07B	 0.15	0.06	0.09

1  The BAM contribution to tolerance in Table 1 is based on maximum
residues from field trial data following the application of dichlobenil
(DP Num: 340366, N. Dodd, 21/NOV/2007; DP Num: 439722, S. Piper,
19/MAR/2008).

2  Dichlobenil contribution to tolerance is calculated by subtracting
the BAM contribution from the existing or recommended tolerance.

3  Although the current established tolerance remains at 0.15 ppm, HED
recommended a tolerance of 0.5 ppm to cover stone fruit crop group based
on limited studies submitted on plums (July 31, 1996; K. Boyle; Dietary
Risk Evaluation System (DRES) )(MRID No. 42452804 and 42452801).

Both the acute and chronic dietary analyses used calculated contribution
values from the dichlobenil contribution column (Table 1) for all
represented commodities.  Previously, residue data from field trials
conducted to support the existing registrations show that, generally,
residues of dichlobenil and metabolites are low, and the use of default
processing factors in the analysis is considered conservative and will
overestimate dietary exposure.  

III.	Drinking Water Data

The EDWCs for dichlobenil residues used in this dietary risk assessment
were obtained from the Environmental Fate and Effects Division (EFED) in
the following memorandum: Drinking Water Assessment for New Use of
Dichlobenil on Rhubarb (DP Num: 322919; J. Angier; 01/NOV/2005) 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.”  Dichlobenil is predicted to volatilize from most surface
waters; therefore, its persistence in the surface water environment will
depend primarily on the environmental factors which control volatility
rates (temperature, wind speed, humidity, etc.).  The EDWCs for
dichlobenil residues used in the acute and the chronic dietary analyses
were 0.298 ppm and 0.0046 ppm, respectively, the concentration estimated
by the Pesticide Root Zone Mode/Exposure Analysis Modeling System
(PRZM/EXAMS) models.  PRZM/EXAMS is an empirical model for predicting
pesticide levels in surface water; the values from PRZM/EXAMS are
considered conservative.  Table 2 summarizes the drinking water
concentrations of dichlbenil 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 2.  EDWCs for Dichlobenil in surface water.

Model Scenario	Peak (acute) Conc. in  Surface Water	1 in 10 Year Annual
Mean (Chronic) Conc. in Surface Water	30 Year Overall (Cancer) Conc. in
Surface Water

OR apple	108.75 ppb	3.724 ppb	1.953 ppb

FL turf	298.3 ppb	4.615 ppb	1.145 ppb

PA turf	78.5 ppb	2.907 ppb	1.159 ppb

IV.	DEEM-FCID( Program and Consumption Information

Dichlobenil 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/Agricultural Research
Service (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 levels of analysis.  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 dichlobenil risk assessment team, relative to
dietary exposure, are summarized in Table 3 (below) (R. Mitkus, updated
24/AUG/2007).

HED determined that the 10X FQPA SF be retained for prechronic oral
exposure scenarios.  This is due to the incompleteness of the database
with regard to the potential of dichlobenil to induce olfactory toxicity
following prechronic oral exposure.  

Table 3.  Summary of Toxicological Doses and Endpoints for Dichlobenil
for Use in Dietary, Residential, and Occupational Human Health Risk
Assessments

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

Acute Dietary (General population, including infants and children)	N/A
N/A	N/A	An endpoint of concern (effect) attributable to a single dose
was not identified in the database. Quantification of acute risk to
general population, including infants and children, is not required.

Acute Dietary (Females 13-49 years of age)	NOAEL = 45

mg/kg/day	UFA = 10X

UFH = 10X

FQPA SF4 = 10X

(includes UFDB = 10X)

(UF = 1000)	aRfD= NOAEL

               UF

aRfD = aPAD = 0.045 mg/kg/day

	Developmental toxicity (rabbit) Offspring LOAEL = 135 mg/kg/day based
on increased incidences of total resorptions/dam, post-implantation
loss, and fetal external, visceral, and skeletal anomalies

Chronic Dietary (All populations)	NOAEL = 1

mg/kg/day	UFA = 10X

UFH = 10X

FQPA SF = 1X

(UF = 100)	cRfD= NOAEL

               UF

cRfD = cPAD = 0.01 mg/kg/day	Chronic toxicity (dog) LOAEL = 6 mg/kg/day
based on increased liver weights and increased serum cholesterol,
triglycerides, phospholipids, and alkaline phosphatase (M&F) and
increased serum -GT and periportal hypertrophy of hepatocytes (M);
olfactory histopathology was assayed and not observed in this study

Cancer	Classification: Group C, possible human carcinogen; RfD approach
should be used for quantification of human risk (2nd Carcinogenicity
Peer Review, 1995)

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.  MOE = margin of exposure.  LOC = level
of concern.  N/A = not applicable.

VI.	Results/Discussion

As discussed above, for acute or chronic dietary assessments, the Agency
is concerned when dietary risk exceeds 100% of the PAD.  The DEEM-FCID(
analyses estimate the dietary exposure of the U.S. population and
various population subgroups.  The results reported in Table 3 (below)
are for the general U.S. 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+ years for chronic exposure and females 13-49 years
for acute exposure.  

Results of Acute Dietary (Food and Drinking Water) Exposure Analysis

The analyses summarized in Tables 4 (below) are based on residue levels
contributed by dichlobenil (Table 1) in all RACs (modified by DEEM(
processing factors, Version 7.81, for processed commodities), and 100%
CT assumptions.  With these assumptions utilized, the risk estimates are
below the Agency’s level of concern.  The only population subgroup
analyzed for acute exposure is females 13-49 years.  Females 13-49 years
have an exposure estimate of 0.014744 mg/kg/day at the 95th percentile,
and utilize 33% of the aPAD.

Results of Chronic Dietary (Food and Drinking Water) Exposure Analysis

The analyses summarized in Table 4 (below) are based on residue levels
contributed by dichlobenil (Table 1) in all RACs (modified by DEEM(
processing factors, Version 7.81, for processed commodities), and 100%
CT assumptions.  With the assumptions utilized, the risk estimates are
well below the Agency’s level of concern.  The most highly exposed
population subgroup is children 1-2 years.  In the analysis, children
1-2 years have an exposure estimate of 0.003000 and utilize 30% of the
cPAD.  

Table 4. Results of Acute and Chronic Dietary (Food + Water) Exposure
and Risk Estimates for Dichlobenil (Parent Only).

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 U.S. Population	

NA 2 	

0.01	

0.000484	

5

All Infants [<1]

0.01	

0.002425	

24

Children [1-2]

0.01	

0.003000	

30

Children [3-5]

0.01	

0.001815	

18

Children [6-12]

0.01	

0.000657	

7

Youths [13-19]

0.01	

0.000270	

3

Adults [20-49]

0.01	

0.000235	

2

Adults [50+]

0.01	

0.000270	

3

Females [13-49]	

0.045	

0.014744	

33	

0.01	

0.000258	

3

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.  

Results of Cancer Dietary (Food and Drinking Water) Exposure Analysis

Dichlobenil is classified as “Group C, possible human carcinogen”
with the RfD approach utilized for quantification of human risk.  The
quantification of cancer risk using the RfD approach is identical to the
assessment for chronic effects; no separate carcinogenic risk assessment
is necessary. 

VII.	Characterization of Inputs/Outputs

Conservative acute and chronic dietary (food and drinking water)
exposure assessments were conducted.  Tolerance level residues and/or
residues contributed by dichlobenil (see Table 1) were used in both
analyses.  Default processing factors (DEEM( version 7.81) were used for
processed commodities.  The assessment assumed 100% of the crops were
treated.  Although not needed at this time, the exposure and risk
estimates could be refined with the following information: 1) projected
market share/percent crop treated data; and 2) anticipated residue data.

VIII.	Conclusions

Acute and chronic dietary (food and drinking water) exposure assessments
were conducted for the proposed uses on rhubarb, caneberry (subgroup
13-07A) and bushberry (subgroup 13-07B).  A conservative assessment was
conducted based on dichlobenil contribution to tolerance level residues
(Table 1), default processing factors and 100% CT.

The acute dietary (food and drinking water) exposure to dichlobenil is
below the Agency’s level of concern for females 13-49 years.  The
acute dietary exposure estimate is 33% of the aPAD.

The chronic dietary (food and drinking water) exposure to dichlobenil is
below the Agency’s level of concern for the general U.S. population
and all population subgroups.  The chronic dietary exposure estimates
are 5% cPAD for the general U.S. population and 30% cPAD for children
1-2 years old, the most highly exposed subgroup.



IX.	List of Attachments

Attachment 1:  Acute Residue Input for Dichlobenil using DEEM-FCID

Attachment 2:  Results of Acute Dietary Exposure Analysis

Attachment 3:  Chronic Residue Input for Dichlobenil using DEEM-FCID

Attachment 4:  Results of Chronic Dietary Exposure Analysis

cc:	William Cutchin and Debra Rate

Attachment 1:  Acute Residue Input for Dichlobenil using DEEM-FCID

U.S. Environmental Protection Agency                                
Ver. 2.02

DEEM-FCID Acute analysis for DICHLOBENIL

Residue file name: E:\dichlobenil\acute
dichlobenil041608-Dichlobenil.R98

Analysis Date 04-16-2008             Residue file dated:
04-16-2008/14:21:50/8

Reference dose: aRfD = 0.045 mg/kg bw/day  NOEL = 45 mg/kg bw/day

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

  EPA    Crop                                   Def Res     Adj.Factors 
 Comment

  Code    Grp  Food Name                         (ppm)       #1    #2   

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

11000070 11   Apple, fruit with peel             0.229000   1.000  1.000

11000080 11   Apple, peeled fruit                0.229000   1.000  1.000

11000081 11   Apple, peeled fruit-babyfood       0.229000   1.000  1.000

11000090 11   Apple, dried                       0.229000   8.000  1.000

11000091 11   Apple, dried-babyfood              0.229000   8.000  1.000

11000100 11   Apple, juice                       0.229000   1.300  1.000

11000101 11   Apple, juice-babyfood              0.229000   1.300  1.000

11000110 11   Apple, sauce                       0.229000   1.000  1.000

11000111 11   Apple, sauce-babyfood              0.229000   1.000  1.000

12000120 12   Apricot                            0.040000   1.000  1.000

12000121 12   Apricot-babyfood                   0.040000   1.000  1.000

12000130 12   Apricot, dried                     0.040000   6.000  1.000

12000140 12   Apricot, juice                     0.040000   1.000  1.000

12000141 12   Apricot, juice-babyfood            0.040000   1.000  1.000

13010550 13A  Blackberry                         0.090000   1.000  1.000

13010560 13A  Blackberry, juice

                 110-Uncooked; Fresh or N/S; Cook Meth N/S

                                                 0.090000   1.000  1.000
 

                 120-Uncooked; Frozen; Cook Meth N/S

                                                 0.090000   1.000  1.000
 

13010561 13A  Blackberry, juice-babyfood         0.090000   1.000  1.000

13020570 13B  Blueberry                          0.090000   1.000  1.000

13020571 13B  Blueberry-babyfood                 0.090000   1.000  1.000

13010580 13A  Boysenberry                        0.090000   1.000  1.000

12000900 12   Cherry                             0.040000   1.000  1.000

12000901 12   Cherry-babyfood                    0.040000   1.000  1.000

12000910 12   Cherry, juice                      0.040000   1.500  1.000

12000911 12   Cherry, juice-babyfood             0.040000   1.500  1.000

11001290 11   Crabapple                          0.229000   1.000  1.000

95001300 O    Cranberry                          0.070000   1.000  1.000

95001301 O    Cranberry-babyfood                 0.070000   1.000  1.000

95001310 O    Cranberry, dried                   0.070000   1.000  1.000

95001320 O    Cranberry, juice                   0.070000   1.100  1.000

95001321 O    Cranberry, juice-babyfood          0.070000   1.100  1.000

13021360 13B  Currant                            0.090000   1.000  1.000

13021370 13B  Currant, dried                     0.090000   1.000  1.000

13011420 13A  Dewberry                           0.090000   1.000  1.000

13021490 13B  Elderberry                         0.090000   1.000  1.000

14001550 14   Filbert                            0.080000   1.000  1.000

14001560 14   Filbert, oil                       0.080000   1.000  1.000

13021740 13B  Gooseberry                         0.090000   1.000  1.000

95001750 O    Grape                              0.060000   1.000  1.000

95001760 O    Grape, juice                       0.060000   1.200  1.000

95001761 O    Grape, juice-babyfood              0.060000   1.200  1.000

95001770 O    Grape, leaves                      0.060000   1.000  1.000

95001780 O    Grape, raisin                      0.060000   4.300  1.000

95001790 O    Grape, wine and sherry             0.060000   1.000  1.000

13021910 13B  Huckleberry                        0.090000   1.000  1.000

13012080 13A  Loganberry                         0.090000   1.000  1.000

12002300 12   Nectarine                          0.040000   1.000  1.000

12002600 12   Peach                              0.040000   1.000  1.000

12002601 12   Peach-babyfood                     0.040000   1.000  1.000

12002610 12   Peach, dried                       0.040000   7.000  1.000

12002611 12   Peach, dried-babyfood              0.040000   7.000  1.000

12002620 12   Peach, juice                       0.040000   1.000  1.000

12002621 12   Peach, juice-babyfood              0.040000   1.000  1.000

11002660 11   Pear                               0.229000   1.000  1.000

11002661 11   Pear-babyfood                      0.229000   1.000  1.000

11002670 11   Pear, dried                        0.229000   6.250  1.000

11002680 11   Pear, juice                        0.229000   1.000  1.000

11002681 11   Pear, juice-babyfood               0.229000   1.000  1.000

12002850 12   Plum                               0.040000   1.000  1.000

12002851 12   Plum-babyfood                      0.040000   1.000  1.000

12002860 12   Plum, prune, fresh                 0.040000   1.000  1.000

12002861 12   Plum, prune, fresh-babyfood        0.040000   1.000  1.000

12002870 12   Plum, prune, dried                 0.040000   5.000  1.000

12002871 12   Plum, prune, dried-babyfood        0.040000   5.000  1.000

12002880 12   Plum, prune, juice                 0.040000   1.400  1.000

12002881 12   Plum, prune, juice-babyfood        0.040000   1.400  1.000

13013200 13A  Raspberry                          0.090000   1.000  1.000

13013201 13A  Raspberry-babyfood                 0.090000   1.000  1.000

13013210 13A  Raspberry, juice                   0.090000   1.000  1.000

13013211 13A  Raspberry, juice-babyfood          0.090000   1.000  1.000

04023220 4B   Rhubarb                            0.050000   1.000  1.000

86010000 O    Water, direct, all sources         0.298000   1.000  1.000

86020000 O    Water, indirect, all sources       0.298000   1.000  1.000

Attachment 2:  Results of Acute Dietary Exposure Analysis

U.S. Environmental Protection Agency                                 
Ver. 2.02

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

Residue file: acute dichlobenil041608-Dichlobenil.R98

Adjustment factor #2 NOT used.

Analysis Date: 04-16-2008/14:29:29    Residue file dated:
04-16-2008/14:21:50/8

NOEL (Acute) =  45.000000 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:

  0.014744   32.76    3052    0.023372   51.94    1925    0.041395  
91.99    1087  



Attachment 3: Chronic Residue Input for Dichlobenil using DEEM-FCID

U.S. Environmental Protection Agency                                
Ver. 2.00

DEEM-FCID Chronic analysis for DICHLOBENIL                       
1994-98 data

Residue file: E:\dichlobenil\chronic dichlobenil041608-Dichlobenil.R98

                                                               Adjust.
#2 used

Analysis Date 04-16-2008             Residue file dated:
04-16-2008/14:23:34/8

Reference dose (RfD) = 0.01  (NOEL) = 1 mg/kg bw/day

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

Food Crop                                       Residue      
Adj.Factors      Comment

EPA Code  Grp  Food Name                          (ppm)       

                                                             #1        
#2 

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

11000070 11   Apple, fruit with peel             0.229000   1.000     
1.000   

11000080 11   Apple, peeled fruit                0.229000   1.000     
1.000   

11000081 11   Apple, peeled fruit-babyfood       0.229000   1.000     
1.000   

11000090 11   Apple, dried                       0.229000   8.000     
1.000   

11000091 11   Apple, dried-babyfood              0.229000   8.000     
1.000   

11000100 11   Apple, juice                       0.229000   1.300     
1.000   

11000101 11   Apple, juice-babyfood              0.229000   1.300     
1.000   

11000110 11   Apple, sauce                       0.229000   1.000     
1.000   

11000111 11   Apple, sauce-babyfood              0.229000   1.000     
1.000   

12000120 12   Apricot                            0.040000   1.000     
1.000   

12000121 12   Apricot-babyfood                   0.040000   1.000     
1.000   

12000130 12   Apricot, dried                     0.040000   6.000     
1.000   

12000140 12   Apricot, juice                     0.040000   1.000     
1.000   

12000141 12   Apricot, juice-babyfood            0.040000   1.000     
1.000   

13010550 13A  Blackberry                         0.090000   1.000     
1.000   

13010560 13A  Blackberry, juice

                110-Uncooked; Fresh or N/S; Cook Meth N/S

                                                 0.090000   1.000     
1.000   

                120-Uncooked; Frozen; Cook Meth N/S

                                                 0.090000   1.000     
1.000   

13010561 13A  Blackberry, juice-babyfood         0.090000   1.000     
1.000   

13020570 13B  Blueberry                          0.090000   1.000     
1.000   

13020571 13B  Blueberry-babyfood                 0.090000   1.000     
1.000   

13010580 13A  Boysenberry                        0.090000   1.000     
1.000   

12000900 12   Cherry                             0.040000   1.000     
1.000   

12000901 12   Cherry-babyfood                    0.040000   1.000     
1.000   

12000910 12   Cherry, juice                      0.040000   1.500     
1.000   

12000911 12   Cherry, juice-babyfood             0.040000   1.500     
1.000   

11001290 11   Crabapple                          0.229000   1.000     
1.000   

95001300 O    Cranberry                          0.070000   1.000     
1.000   

95001301 O    Cranberry-babyfood                 0.070000   1.000     
1.000   

95001310 O    Cranberry, dried                   0.070000   1.000     
1.000   

95001320 O    Cranberry, juice                   0.070000   1.100     
1.000   

95001321 O    Cranberry, juice-babyfood          0.070000   1.100     
1.000   

13021360 13B  Currant                            0.090000   1.000     
1.000   

13021370 13B  Currant, dried                     0.090000   1.000     
1.000   

13011420 13A  Dewberry                           0.090000   1.000     
1.000   

13021490 13B  Elderberry                         0.090000   1.000     
1.000   

14001550 14   Filbert                            0.080000   1.000     
1.000   

14001560 14   Filbert, oil                       0.080000   1.000     
1.000   

13021740 13B  Gooseberry                         0.090000   1.000     
1.000   

95001750 O    Grape                              0.060000   1.000     
1.000   

95001760 O    Grape, juice                       0.060000   1.200     
1.000   

95001761 O    Grape, juice-babyfood              0.060000   1.200     
1.000   

95001770 O    Grape, leaves                      0.060000   1.000     
1.000   

95001780 O    Grape, raisin                      0.060000   4.300     
1.000   

95001790 O    Grape, wine and sherry             0.060000   1.000     
1.000   

13021910 13B  Huckleberry                        0.090000   1.000     
1.000   

13012080 13A  Loganberry                         0.090000   1.000     
1.000   

12002300 12   Nectarine                          0.040000   1.000     
1.000   

12002600 12   Peach                              0.040000   1.000     
1.000   

12002601 12   Peach-babyfood                     0.040000   1.000     
1.000   

12002610 12   Peach, dried                       0.040000   7.000     
1.000   

12002611 12   Peach, dried-babyfood              0.040000   7.000     
1.000   

12002620 12   Peach, juice                       0.040000   1.000     
1.000   

12002621 12   Peach, juice-babyfood              0.040000   1.000     
1.000   

11002660 11   Pear                               0.229000   1.000     
1.000   

11002661 11   Pear-babyfood                      0.229000   1.000     
1.000   

11002670 11   Pear, dried                        0.229000   6.250     
1.000   

11002680 11   Pear, juice                        0.229000   1.000     
1.000   

11002681 11   Pear, juice-babyfood               0.229000   1.000     
1.000   

12002850 12   Plum                               0.040000   1.000     
1.000   

12002851 12   Plum-babyfood                      0.040000   1.000     
1.000   

12002860 12   Plum, prune, fresh                 0.040000   1.000     
1.000   

12002861 12   Plum, prune, fresh-babyfood        0.040000   1.000     
1.000   

12002870 12   Plum, prune, dried                 0.040000   5.000     
1.000   

12002871 12   Plum, prune, dried-babyfood        0.040000   5.000     
1.000   

12002880 12   Plum, prune, juice                 0.040000   1.400     
1.000   

12002881 12   Plum, prune, juice-babyfood        0.040000   1.400     
1.000   

13013200 13A  Raspberry                          0.090000   1.000     
1.000   

13013201 13A  Raspberry-babyfood                 0.090000   1.000     
1.000   

13013210 13A  Raspberry, juice                   0.090000   1.000     
1.000   

13013211 13A  Raspberry, juice-babyfood          0.090000   1.000     
1.000   

04023220 4B   Rhubarb                            0.050000   1.000     
1.000   

86010000 O    Water, direct, all sources         0.004600   1.000     
1.000   

86020000 O    Water, indirect, all sources       0.004600   1.000     
1.000   

Attachment 4: Results of Chronic Dietary Exposure Analysis

U.S. Environmental Protection Agency                                
Ver. 2.00

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

Residue file name: E:\dichlobenil\chronic
dichlobenil041608-Dichlobenil.R98

                                                     Adjustment factor
#2 used.

Analysis Date 04-16-2008/14:24:30     Residue file dated:
04-16-2008/14:23:34/8

Reference dose (RfD, Chronic) = .01 mg/kg bw/day

NOEL (Chronic) = 1 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)                     0.000484        2,066       
4.8%

U.S. Population (spring season)             0.000474        2,108       
4.7%

U.S. Population (summer season)             0.000457        2,188       
4.6%

U.S. Population (autumn season)             0.000509        1,965       
5.1%

U.S. Population (winter season)             0.000495        2,020       
5.0%

Northeast region                            0.000547        1,827       
5.5%

Midwest region                              0.000480        2,082       
4.8%

Southern region                             0.000422        2,372       
4.2%

Western region                              0.000530        1,885       
5.3%

Hispanics                                   0.000545        1,833       
5.5%

Non-hispanic whites                         0.000471        2,122       
4.7%

Non-hispanic blacks                         0.000478        2,092       
4.8%

Non-hisp/non-white/non-black                0.000562        1,780       
5.6%

All infants (< 1 year)                      0.002425          412      
24.2%

Nursing infants                             0.001289          776      
12.9%

Non-nursing infants                         0.002856          350      
28.6%

Children 1-6  yrs                           0.002089          479      
20.9%

Children 7-12 yrs                           0.000578        1,731       
5.8%

Females 13-19 (not preg or nursing)         0.000297        3,364       
3.0%

Females 20+ (not preg or nursing)           0.000256        3,903       
2.6%

Females 13-50 yrs                           0.000302        3,311       
3.0%

Females 13+ (preg/not nursing)              0.000428        2,337       
4.3%

Females 13+ (nursing)                       0.000396        2,526       
4.0%

Males 13-19 yrs                             0.000243        4,122       
2.4%

Males 20+ yrs                               0.000233        4,297       
2.3%

Seniors 55+                                 0.000277        3,610       
2.8%

Children 1-2 yrs                            0.003000          333      
30.0%

Children 3-5 yrs                            0.001815          551      
18.2%

态ú萏֠萑褐葞֠葠褐

됂逃$愂Ĥ摧㩰§

瑹幭[T欀

	

 

%

(

瑹幭[Ԁ(

)

*

+

,

p

²

Ò

Ü

ß

ì

î

õ

ö

@

A

B

J

U

V

g

h

i

hÜ

h’

, 

7

p

´

Ò

Ó

ö

A

U

h

i

  h’

਀&䘋

态ú摧扑É਀&䘋

Q

h`

h`

愀Ĥ摧âÈ

愀Ĥ摧âÈ

愀Ĥ摧âÈ

@

 h’

 h’

\

&

@

 h’

,

@

 h’

 0.000270        3,710        2.7%

Females 13-49 yrs                           0.000258        3,872       
2.6%

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

	

Dichlobenil	Dietary Exposure Assessment	DP Num:	346388

PC Code: 027401		Page:   PAGE  14  of   NUMPAGES  14