Document ID: EPA-HQ-OPP-2007-0106-0006
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2007-09-19T04:00Z

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, D.C.  20460

OFFICE OF              

PREVENTION, PESTICIDES

AND TOXIC SUBSTANCES 

MEMORANDUM

DATE:        02/AUG/2007

SUBJECT:  Pendimethalin:  Chronic Dietary (Food and Drinking Water)
Analysis and Risk Assessment to Support the Section 3 Registration for
New Food Uses of the Herbicide on Artichoke, Asparagus, Brassica Head
and Stem Vegetables, Subgroup 5A, and Grape.

PC Code:				108501	

DP Number:			334173

Decision Numbers:			371520

Petition Numbers:			6E7129

Regulatory Citation:			40CFR §180.361

Chemical Class:			Dinitroaniline Herbicide

Trade Names:			Prowl® 3.3 EC, Prowl® H2O

EPA Registration Numbers:		241-337, 241-418

Reviewer:	Debra Rate, Ph.D., Biologist

		Alternative Risk Integration and Assessment (ARIA)

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

		Registration Division (RD) (7505P)

Through:	William Cutchin, Acting Senior Branch Scientist

		ARIA

		RIMUERB/RD (7505P)

			And

		Douglas Dotson, Ph. D., Chemist

		Amelia Acierto, Chemist

		Dietary Exposure Science Advisory Council (DESAC)

		Health Effects Division (HED) (7509P)

Through:	Dan Rosenblatt / Barbara Madden

		RIMUERB/RD (7505P)

Executive Summary

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

A chronic dietary risk assessment was conducted using the Dietary
Exposure Evaluation Model (DEEM-FCID, Version 2.03) which uses food
consumption data from the US Department of Agriculture’s Continuing
Surveys of Food Intakes by Individuals (CSFII) from 1994 to 1996, and
1998.  The analysis was performed in order to determine the exposure and
risk estimates which result from the addition of artichoke, globe;
asparagus, Brassica head and stem vegetables, subgroup 5A, and grapes to
the commodity residue list for pendimethalin.  The proposed tolerances
are associated with Section 3 requests.

The chronic dietary exposure analysis was based on the following
assumptions:  

(1) Tolerance-level residues of pendimethalin in/on all current RACs
(e-CFR 40 §180.361, Updated July 1, 2007) and proposed RACs.

(2) Empirical processing factors obtained from processing studies (when
available; including citrus commodities).  Grape processing studies were
not adequate, and tolerances for grape commodities (grape, raisin and
grape, juice) were recommended and no processing factor was used in the
dietary analysis.

(3) A processing factor of 8 for the processed commodities of wheat bran
and wheat germ and 1.4 for wheat flour.

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

(5) 100% crop treated (CT), and 

(6) 0.006 ppm pendimethalin estimated drinking water concentration
(EDWC).  

These assumptions result in conservative estimates of dietary exposure
and risk.  In calculating dietary risk estimates, ARIA has compared the
chronic population-adjusted dose (cPAD) to the estimated dietary
exposure.  Typically, ARIA has concerns regarding dietary risk when the
estimates exceed 100% of the cPAD.  Even with the conservative
assumptions noted above, risk estimates associated with dietary exposure
to pendimethalin are significantly below ARIA’s level of concern.  

In the chronic dietary assessment, the most highly exposed population
subgroup is children 1-2 years old.  The chronic exposure estimate of
0.004749 mg/kg/day corresponds to approximately 16% of the cPAD.  Risks
for the general US population were 5% of the cPAD.

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.  This is the
population adjusted dose (PAD), which ARIA has concluded will result in
no unreasonable adverse health effects.  The PAD is equivalent to point
of departure (POD, NOAEL, LOAEL, e.g.) divided by the required
uncertainty factors.  Dietary risk is expressed as a percentage of the
PAD.  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, 21/JUN/2000, web link: 
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 pendimethalin was conducted
by W. Drew (DP Num: 329175, W. Drew, 30/JUN/2006).

II.	Residue Information

Permanent and time-limited tolerances are currently established for
combined residues of the herbicide pendimethalin,
N-(1-ethylpropyl)-3,4-dimethyl-2,6-dinitrobenzenamine, and its
metabolite, 4-[(1-ethylpropyl)amino]-2-methyl-3,5-dinitrobenzyl alcohol,
in/on various plant commodities, as listed in 40CFR §180.361[a] and [b]
(e-CFR 40CFR §180.361, updated July 1, 2007).  In addition to the
current tolerances, the recommended tolerances for the proposed new uses
in/on artichoke, globe at 0.1 ppm; asparagus at 0.15 ppm; Brassica head
and stem vegetables, subgroup 5A at 0.1 ppm; grapes at 0.1 ppm; raisin
at 0.5 ppm and grape juice at 0.15 ppm (DP Num: 340343; D. Rate;
02/AUG/2007) were used in the analysis.

Tolerance-level residues of pendimethalin were utilized for all RACs,
current and proposed, with exception of grape juice and raisins which
are recommended by ARIA due to the submission of inadequate grape
processing studies.  Empirical processing factors obtained from
processing study data were utilized for processed commodities, when
available and adequate.  Wheat processing data have not been submitted,
therefore, a processing factor of 8 was used for the processed
commodities wheat germ and bran and 1.4 for wheat flour (the maximum
theoretical concentration factor for wheat, from Table 1 of OPPTS
Residue Chemistry Test Guideline 860.1520) (DP Num: 329175, W. Drew,
30/JUN/2006; personal communication R. Loranger (19/JUL/2007)).  For the
currently proposed processed commodities (grape), processing factors
could not be calculated   SEQ CHAPTER \h \r 1 because residues were
below the limit of quantitation (LOQ) in both the RAC and the processed
fractions (DP Num: 340343; D. Rate; 02/AUG/2007).  DEEM™ 7.81
processing factors were utilized for processed commodities (other than
wheat and citrus (DP Num: 238469, W. Cutchin, 21/JUL/1999)) associated
with the previously registered uses for fruiting vegetables (tomato),
pome fruit, and stone fruit (DP Num: 329175; W. Drew; 30/JUN/2006).  One
hundred %CT was assumed for all foods in this assessment.  

III.	Drinking Water Data

The drinking water residues used in this chronic dietary risk assessment
were provided by the Environmental Fate and Effects Division (EFED) in a
memorandum (D334061; J. Breithaupt; 08/MAY/2007), and incorporated
directly into the dietary assessment.  Water residues were entered into
the DEEM-FCID input file under the food categories “water, direct, all
sources” and “water, indirect, all sources.”  

The EDWC of 0.006 ppm (the 1 in 10 year annual mean concentration in
surface water, as calculated by PRZM-EXAMS modeling) was directly
entered into the exposure model to assess the contributions from
drinking water.  This EDWC (resulting from a single application of
pendimethalin to grapes (NY) at the rate of 6.0 lb ai/A) was the highest
modeling result calculated for either surface or groundwater sources of
drinking water, and is therefore conservative.

The PRZM-EXAMS Model and its description are available at the EPA
internet site (web link   HYPERLINK
"http://www.epa.gov/oppefed1/models/water/" 
http://www.epa.gov/oppefed1/models/water/ ).  

III.	DEEM-FCID Program and Consumption Information

 (DEEM-FCID™, Version 2.03), which incorporates consumption data from
USDA’s Continuing Surveys of Food Intakes by Individuals (CSFII), from
1994 to 1996, and 1998.  The 1994-96 & 1998 data are based on the
reported consumption of more than 20,000 individuals over two
non-consecutive survey days.  Foods “as consumed” (such as apple
pie) are linked to EPA-defined food commodities (such as apples, peeled
fruit - cooked, fresh/unspecified, or baked; or wheat flour - cooked,
fresh/unspecified, or 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 US population,
and within population subgroups.  Based on analysis of the 1994-96 &
1998 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 US
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 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.

IV.	Toxicological Information

Endpoints and doses for risk assessment were selected to support
previous risk assessments in 2000; evaluation of the database in
accordance with the Food Quality Protection Act (FQPA) of 1996 was also
completed in 2000.  Since that time, there have been changes in the way
the Agency has applied the FQPA Safety Factor, based on guidance issued
in 2002.  

The most recent evaluation of the toxicity database for pendimethalin is
summarized in the most recent risk assessment (DP Num: 344766, W. Drew,
23/MAR/2007).  The total uncertainty factor (UF) for dietary exposure is
based on a 3X interspecies factor, a 10X intraspecies factor, and a 10X
database UF retained pending receipt of a developmental thyroid toxicity
study.  

Doses and endpoints for dietary risk assessment are presented in Table 1
(below).  Although HED concluded that pendimethalin is a likely human
carcinogen, a nonlinear approach to cancer risk assessment was
recommended by the Cancer Assessment Review Committee (CARC).  The
chronic dietary risk assessment, based on the calculated RfD, is
considered to be protective of cancer risk arising from potential
carcinogenic effects.  In addition, no appropriate endpoint attributable
to a single dose (exposure) was identified in the available studies.  As
such, a chronic dietary analysis is required, while an acute dietary
analysis is not.  

TABLE 1	Summary of Pendimethalin Toxicological Doses and Endpoints for
Use in Dietary Exposure Assessment.  

Exposure Scenario	Dose Used in Risk Assessment, UF	FQPA SF, Level of
Concern for Risk Assessment	Study and Toxicological Effects

Acute Dietary	No appropriate endpoint attributable to a single dose
(exposure) was identified in the available studies.  

Chronic Dietary

(All populations)	NOAEL = 10 mg/kg/day

Total UF = 300X

Chronic RfD = 

NOAEL ÷ UF = 

0.03 mg/kg/day	FQPA SF = 1X

cPAD = 

Chronic RfD ÷ FQPA SF = 0.03 mg/kg/day	56-day thyroid study in rats;
14-day intra thyroid metabolism study in rats;

92-day thyroid function study in rats.  

LOAEL= 31 mg/kg/day, based on hormonal and histopathological changes in
the thyroid.  

Cancer	Pendimethalin is considered to be a possible human carcinogen. 
The chronic dietary assessment using the cPAD is considered to be
protective of cancer effects.  	2-year chronic/carcinogenicity study in
rats.  

UF = Uncertainty Factor.  

FQPA SF = FQPA Safety Factor.  

NOAEL = No Observed Adverse Effect Level.  

LOAEL = Lowest Observed Adverse Effect Level.  

PAD = Population Adjusted Dose (a = acute, c = chronic).  

RfD = Reference Dose.  

V.	Results/Discussion

As stated above, ARIA is concerned when dietary risk exceeds 100% of the
PAD.  The results of the pendimethalin chronic dietary assessment
reported in Table 2 are for the general US Population, all infants (<1
year old), children 1-2, children 3-5, children 6-12, youth 13-19,
females 13-49, adults 20-49, and adults 50+ years.  

The most highly exposed population subgroup is children 1-2 years old,
with an estimated chronic exposure of 0.004749 mg/kg/day, corresponding
to approximately 16% of the cPAD.  Exposure and risk estimates for the
general US population (0.001548 mg/kg/day, 5% of the cPAD) and all other
population subgroups were lower.

The summarized results of the chronic dietary exposure analysis are
listed in Table 2 (below).  

TABLE 2	Summary of Chronic Dietary Exposure and Risk Estimates for
Pendimethalin.  

Population Subgroup*

[Years of Age]	DEEM Chronic Dietary Analysis

	cPAD (mg/kg/day)	Exposure Estimate (mg/kg/day)	% cPAD

General US Population	0.03	0.001548	5

All Infants [<1]	0.03	0.003081	10

Children [1-2]	0.03	0.004749	16

Children [3-5]	0.03	0.003819	13

Children [6-12]	0.03	0.002304	8

Youths [13-19]	0.03	0.001417	5

Adults [20-49]	0.03	0.001166	4

Adults [50+]	0.03	0.001065	4

Females [13-49]	0.03	0.001164	4

* Values for the population with the highest risk are in bold type.  

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 pendimethalin. 

VIII.	Conclusions

Based on conservative assumptions, dietary risk estimates for
pendimethalin do not exceed ARIA’s level of concern for the general US
population, or any of the population subgroups, including those
comprised of infants and children.  

IX.	List of Attachments

Attachment 1:  Commodity Contribution List for Pendimethalin.  

Attachment 2:  Results of Pendimethalin Chronic Dietary Exposure
Analysis.  

cc:	D. Rate and W. Cutchin

ATTACHMENT 1: 

U.S. Environmental Protection Agency                                
Ver. 2.00

DEEM-FCID Chronic analysis for PENDIMETHALIN                     
1994-98 data

Residue file: E:\pendimethalin\DEEM for Secondary\FINAL\c108501 D334173
073107.R98

                                                           Adjust. #2
NOT used

Analysis Date 07-31-2007             Residue file dated:
07-31-2007/14:14:09/8

Reference dose (RfD) = 0.03  (NOEL) = 10 mg/kg bw/day

Comment:FQPA Safety Factor = 1X; DBUFs = 300X; no acute dose/endpoint

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

Food Crop                                       Residue      
Adj.Factors      Comment

EPA Code  Grp  Food Name                          (ppm)       

                                                             #1        
#2 

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

18000020 18   Alfalfa, seed                      0.100000   1.000     
1.000   

14000030 14   Almond                             0.100000   1.000     
1.000   

14000031 14   Almond-babyfood                    0.100000   1.000     
1.000   

14000040 14   Almond, oil                        0.100000   1.000     
1.000   

14000041 14   Almond, oil-babyfood               0.100000   1.000     
1.000   

11000070 11   Apple, fruit with peel             0.100000   1.000     
1.000   

11000080 11   Apple, peeled fruit                0.100000   1.000     
1.000   

11000081 11   Apple, peeled fruit-babyfood       0.100000   1.000     
1.000   

11000090 11   Apple, dried                       0.100000   8.000     
1.000   

11000091 11   Apple, dried-babyfood              0.100000   8.000     
1.000   

11000100 11   Apple, juice                       0.100000   1.300     
1.000   

11000101 11   Apple, juice-babyfood              0.100000   1.300     
1.000   

11000110 11   Apple, sauce                       0.100000   1.000     
1.000   

11000111 11   Apple, sauce-babyfood              0.100000   1.000     
1.000   

12000120 12   Apricot                            0.100000   1.000     
1.000   

12000121 12   Apricot-babyfood                   0.100000   1.000     
1.000   

12000130 12   Apricot, dried                     0.100000   6.000     
1.000   

12000140 12   Apricot, juice                     0.100000   1.000     
1.000   

12000141 12   Apricot, juice-babyfood            0.100000   1.000     
1.000   

95000160 O    Artichoke, globe                   0.100000   1.000     
1.000   PP#6E7

  Full comment: PP#6E7129

95000190 O    Asparagus                          0.150000   1.000     
1.000   PP#6E7

  Full comment: PP#6E7129

06020370 6B   Bean, lima, succulent              0.100000   1.000     
1.000   

06030380 6C   Bean, lima, seed                   0.100000   1.000     
1.000   

14000590 14   Brazil nut                         0.100000   1.000     
1.000   

05010610 5A   Broccoli                           0.100000   1.000     
1.000   PP#6E7

  Full comment: PP#6E7129

05010611 5A   Broccoli-babyfood                  0.100000   1.000     
1.000   PP#6E7

  Full comment: PP#6E7129

05010620 5A   Broccoli, Chinese                  0.100000   1.000     
1.000   PP#6E7

  Full comment: PP#6E7129

05010640 5A   Brussels sprouts                   0.100000   1.000     
1.000   PP#6E7

  Full comment: PP#6E7129

14000680 14   Butternut                          0.100000   1.000     
1.000   

05010690 5A   Cabbage                            0.100000   1.000     
1.000   PP#6E7

  Full comment: PP#6E7129

05010710 5A   Cabbage, Chinese, napa             0.100000   1.000     
1.000   PP#6E7

  Full comment: PP#6E7129

05010720 5A   Cabbage, Chinese, mustard          0.100000   1.000     
1.000   PP#6E7

  Full comment: PP#6E7129

01010780 1AB  Carrot                             0.500000   1.000     
1.000   

01010781 1AB  Carrot-babyfood                    0.500000   1.000     
1.000   

01010790 1AB  Carrot, juice                      0.500000   1.000     
1.000   

14000810 14   Cashew                             0.100000   1.000     
1.000   

05010830 5A   Cauliflower                        0.100000   1.000     
1.000   PP#6E7

  Full comment: PP#6E7129

12000900 12   Cherry                             0.100000   1.000     
1.000   

12000901 12   Cherry-babyfood                    0.100000   1.000     
1.000   

12000910 12   Cherry, juice                      0.100000   1.500     
1.000   

12000911 12   Cherry, juice-babyfood             0.100000   1.500     
1.000   

14000920 14   Chestnut                           0.100000   1.000     
1.000   

10001060 10   Citrus citron                      0.100000   1.000     
1.000   

10001070 10   Citrus hybrids                     0.100000   1.000     
1.000   

10001080 10   Citrus, oil                        0.500000   1.000     
1.000   

15001200 15   Corn, field, flour                 0.100000   1.000     
1.000   

15001201 15   Corn, field, flour-babyfood        0.100000   1.000     
1.000   

15001210 15   Corn, field, meal                  0.100000   1.000     
1.000   

15001211 15   Corn, field, meal-babyfood         0.100000   1.000     
1.000   

15001220 15   Corn, field, bran                  0.100000   1.000     
1.000   

15001230 15   Corn, field, starch                0.100000   1.000     
1.000   

15001231 15   Corn, field, starch-babyfood       0.100000   1.000     
1.000   

15001240 15   Corn, field, syrup                 0.100000   1.500     
1.000   

15001241 15   Corn, field, syrup-babyfood        0.100000   1.500     
1.000   

15001250 15   Corn, field, oil                   0.100000   1.000     
1.000   

15001251 15   Corn, field, oil-babyfood          0.100000   1.000     
1.000   

15001260 15   Corn, pop                          0.100000   1.000     
1.000   

15001270 15   Corn, sweet                        0.100000   1.000     
1.000   

15001271 15   Corn, sweet-babyfood               0.100000   1.000     
1.000   

95001280 O    Cottonseed, oil                    0.100000   1.000     
1.000   

95001281 O    Cottonseed, oil-babyfood           0.100000   1.000     
1.000   

11001290 11   Crabapple                          0.100000   1.000     
1.000   

08001480 8    Eggplant                           0.100000   1.000     
1.000   

14001550 14   Filbert                            0.100000   1.000     
1.000   

14001560 14   Filbert, oil                       0.100000   1.000     
1.000   

03001640 3    Garlic                             0.100000   1.000     
1.000   

03001650 3    Garlic, dried                      0.100000   1.000     
1.000   

03001651 3    Garlic, dried-babyfood             0.100000   1.000     
1.000   

95001750 O    Grape                              0.100000   1.000     
1.000   PP#6E7

  Full comment: PP#6E7129

95001760 O    Grape, juice                       0.150000   1.000     
1.000   PP#6E7

  Full comment: PP#6E7129

95001761 O    Grape, juice-babyfood              0.150000   1.000     
1.000   PP#6E7

  Full comment: PP#6E7129

95001770 O    Grape, leaves                      0.100000   1.000     
1.000   PP#6E7

  Full comment: PP#6E7129

95001780 O    Grape, raisin                      0.500000   1.000     
1.000   PP#6E7

  Full comment: PP#6E7129

95001790 O    Grape, wine and sherry             0.100000   1.000     
1.000   PP#6E7

  Full comment: PP#6E7129

10001800 10   Grapefruit                         0.100000   1.000     
1.000   

10001810 10   Grapefruit, juice                  0.100000   1.000     
1.000   

14001850 14   Hickory nut                        0.100000   1.000     
1.000   

05011960 5A   Kohlrabi                           0.100000   1.000     
1.000   PP#6E7

  Full comment: PP#6E7129

10001970 10   Kumquat                            0.100000   1.000     
1.000   

03001980 3    Leek                               0.200000   1.000     
1.000   

10001990 10   Lemon                              0.100000   1.000     
1.000   

10002000 10   Lemon, juice                       0.100000   1.000     
1.000   

10002001 10   Lemon, juice-babyfood              0.100000   1.000     
1.000   

10002010 10   Lemon, peel                        0.100000   1.000     
1.000   

10002060 10   Lime                               0.100000   1.000     
1.000   

10002070 10   Lime, juice                        0.100000   1.000     
1.000   

10002071 10   Lime, juice-babyfood               0.100000   1.000     
1.000   

11002100 11   Loquat                             0.100000   1.000     
1.000   

14002130 14   Macadamia nut                      0.100000   1.000     
1.000   

12002300 12   Nectarine                          0.100000   1.000     
1.000   

08002340 8    Okra                               0.100000   1.000     
1.000   

03002370 3    Onion, dry bulb                    0.100000   1.000     
1.000   

03002371 3    Onion, dry bulb-babyfood           0.100000   1.000     
1.000   

03002380 3    Onion, dry bulb, dried             0.100000   9.000     
1.000   

03002381 3    Onion, dry bulb, dried-babyfood    0.100000   9.000     
1.000   

03002390 3    Onion, green                       0.200000   1.000     
1.000   

10002400 10   Orange                             0.100000   1.000     
1.000   

10002410 10   Orange, juice                      0.100000   1.000     
1.000   

10002411 10   Orange, juice-babyfood             0.100000   1.000     
1.000   

10002420 10   Orange, peel                       0.100000   1.000     
1.000   

06022550 6B   Pea, succulent                     0.100000   1.000     
1.000   

06022551 6B   Pea, succulent-babyfood            0.100000   1.000     
1.000   

06012570 6A   Pea, edible podded, succulent      0.100000   1.000     
1.000   

06022590 6B   Pea, pigeon, succulent             0.100000   1.000     
1.000   

12002600 12   Peach                              0.100000   1.000     
1.000   

12002601 12   Peach-babyfood                     0.100000   1.000     
1.000   

12002610 12   Peach, dried                       0.100000   7.000     
1.000   

12002611 12   Peach, dried-babyfood              0.100000   7.000     
1.000   

12002620 12   Peach, juice                       0.100000   1.000     
1.000   

12002621 12   Peach, juice-babyfood              0.100000   1.000     
1.000   

95002630 O    Peanut                             0.100000   1.000     
1.000   

95002640 O    Peanut, butter                     0.100000   1.890     
1.000   

95002650 O    Peanut, oil                        0.100000   1.000     
1.000   

11002660 11   Pear                               0.100000   1.000     
1.000   

11002661 11   Pear-babyfood                      0.100000   1.000     
1.000   

11002670 11   Pear, dried                        0.100000   6.250     
1.000   

11002680 11   Pear, juice                        0.100000   1.000     
1.000   

11002681 11   Pear, juice-babyfood               0.100000   1.000     
1.000   

14002690 14   Pecan                              0.100000   1.000     
1.000   

08002700 8    Pepper, bell                       0.100000   1.000     
1.000   

08002701 8    Pepper, bell-babyfood              0.100000   1.000     
1.000   

08002710 8    Pepper, bell, dried                0.100000   1.000     
1.000   

08002711 8    Pepper, bell, dried-babyfood       0.100000   1.000     
1.000   

08002720 8    Pepper, nonbell                    0.100000   1.000     
1.000   

08002721 8    Pepper, nonbell-babyfood           0.100000   1.000     
1.000   

08002730 8    Pepper, nonbell, dried             0.100000   1.000     
1.000   

95002750 O    Peppermint                         0.200000   1.000     
1.000   

95002760 O    Peppermint, oil                    1.000000   1.000     
1.000   

14002820 14   Pistachio                          0.100000   1.000     
1.000   

12002850 12   Plum                               0.100000   1.000     
1.000   

12002851 12   Plum-babyfood                      0.100000   1.000     
1.000   

12002860 12   Plum, prune, fresh                 0.100000   1.000     
1.000   

12002861 12   Plum, prune, fresh-babyfood        0.100000   1.000     
1.000   

12002870 12   Plum, prune, dried                 0.100000   5.000     
1.000   

12002871 12   Plum, prune, dried-babyfood        0.100000   5.000     
1.000   

12002880 12   Plum, prune, juice                 0.100000   1.400     
1.000   

12002881 12   Plum, prune, juice-babyfood        0.100000   1.400     
1.000   

95002890 O    Pomegranate                        0.100000   1.000     
1.000   

01032960 1C   Potato, chips                      0.100000   1.000     
1.000   

01032970 1C   Potato, dry (granules/ flakes)     0.100000   6.500     
1.000   

01032971 1C   Potato, dry (granules/ flakes)-b   0.100000   6.500     
1.000   

01032980 1C   Potato, flour                      0.100000   6.500     
1.000   

01032981 1C   Potato, flour-babyfood             0.100000   6.500     
1.000   

01032990 1C   Potato, tuber, w/peel              0.100000   1.000     
1.000   

01032991 1C   Potato, tuber, w/peel-babyfood     0.100000   1.000     
1.000   

01033000 1C   Potato, tuber, w/o peel            0.100000   1.000     
1.000   

01033001 1C   Potato, tuber, w/o peel-babyfood   0.100000   1.000     
1.000   

10003070 10   Pummelo                            0.100000   1.000     
1.000   

11003100 11   Quince                             0.100000   1.000     
1.000   

15003230 15   Rice, white                        0.100000   1.000     
1.000   

15003231 15   Rice, white-babyfood               0.100000   1.000     
1.000   

15003240 15   Rice, brown                        0.100000   1.000     
1.000   

15003241 15   Rice, brown-babyfood               0.100000   1.000     
1.000   

15003250 15   Rice, flour                        0.100000   1.000     
1.000   

15003251 15   Rice, flour-babyfood               0.100000   1.000     
1.000   

15003260 15   Rice, bran                         0.100000   1.000     
1.000   

15003261 15   Rice, bran-babyfood                0.100000   1.000     
1.000   

03003380 3    Shallot                            0.200000   1.000     
1.000   

15003440 15   Sorghum, grain                     0.100000   1.000     
1.000   

15003450 15   Sorghum, syrup                     0.100000   1.000     
1.000   

06003470 6    Soybean, seed                      0.100000   1.000     
1.000   

06003480 6    Soybean, flour                     0.100000   1.000     
1.000   

06003481 6    Soybean, flour-babyfood            0.100000   1.000     
1.000   

06003490 6    Soybean, soy milk                  0.100000   1.000     
1.000   

06003491 6    Soybean, soy milk-babyfood or in   0.100000   1.000     
1.000   

06003500 6    Soybean, oil                       0.100000   1.000     
1.000   

06003501 6    Soybean, oil-babyfood              0.100000   1.000     
1.000   

95003520 O    Spearmint                          0.200000   1.000     
1.000   

95003530 O    Spearmint, oil                     1.000000   1.000     
1.000   

95003590 O    Strawberry                         0.100000   1.000     
1.000   

95003591 O    Strawberry-babyfood                0.100000   1.000     
1.000   

95003600 O    Strawberry, juice                  0.100000   1.000     
1.000   

95003601 O    Strawberry, juice-babyfood         0.100000   1.000     
1.000   

95003620 O    Sugarcane, sugar                   0.100000   1.000     
1.000   

95003621 O    Sugarcane, sugar-babyfood          0.100000   1.000     
1.000   

95003630 O    Sugarcane, molasses                0.100000   1.000     
1.000   

95003631 O    Sugarcane, molasses-babyfood       0.100000   1.000     
1.000   

20003640 20   Sunflower, seed                    0.100000   1.000     
1.000   

20003650 20   Sunflower, oil                     0.100000   1.000     
1.000   

20003651 20   Sunflower, oil-babyfood            0.100000   1.000     
1.000   

10003690 10   Tangerine                          0.100000   1.000     
1.000   

10003700 10   Tangerine, juice                   0.100000   1.000     
1.000   

08003740 8    Tomatillo                          0.100000   1.000     
1.000   

08003750 8    Tomato                             0.100000   1.000     
1.000   

08003751 8    Tomato-babyfood                    0.100000   1.000     
1.000   

08003760 8    Tomato, paste                      0.100000   5.400     
1.000   

08003761 8    Tomato, paste-babyfood             0.100000   5.400     
1.000   

08003770 8    Tomato, puree                      0.100000   3.300     
1.000   

08003771 8    Tomato, puree-babyfood             0.100000   3.300     
1.000   

08003780 8    Tomato, dried                      0.100000  14.300     
1.000   

08003781 8    Tomato, dried-babyfood             0.100000  14.300     
1.000   

08003790 8    Tomato, juice                      0.100000   1.500     
1.000   

14003910 14   Walnut                             0.100000   1.000     
1.000   

86010000 O    Water, direct, all sources         0.006000   1.000     
1.000   PP#6E7

  Full comment: PP#6E7129

86020000 O    Water, indirect, all sources       0.006000   1.000     
1.000   PP#6E7

  Full comment: PP#6E7129

15004010 15   Wheat, grain                       0.100000   1.000     
1.000   

15004011 15   Wheat, grain-babyfood              0.100000   1.000     
1.000   

15004020 15   Wheat, flour                       0.100000   1.400     
1.000   

15004021 15   Wheat, flour-babyfood              0.100000   1.400     
1.000   

15004030 15   Wheat, germ                        0.100000   8.000     
1.000   

15004040 15   Wheat, bran                        0.100000   8.000     
1.000   

15004050 15   Wild rice                          0.100000   1.000     
1.000   

ATACHEMNT 2:

U.S. Environmental Protection Agency                                
Ver. 2.00

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

Residue file name: E:\pendimethalin\DEEM for Secondary\FINAL\c108501
D334173 073107.R98

                                                 Adjustment factor #2
NOT used.

Analysis Date 07-31-2007/14:15:55     Residue file dated:
07-31-2007/14:14:09/8

Reference dose (RfD, Chronic) = .03 mg/kg bw/day

NOEL (Chronic) = 10 mg/kg bw/day

COMMENT 1: FQPA Safety Factor = 1X; DBUFs = 300X; no acute dose/endpoint

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

                    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)                     0.001548        6,459       
5.2%

U.S. Population (spring season)             0.001546        6,467       
5.2%

U.S. Population (summer season)             0.001528        6,544       
5.1%

U.S. Population (autumn season)             0.001545        6,474       
5.1%

U.S. Population (winter season)             0.001576        6,344       
5.3%

Northeast region                            0.001622        6,166       
5.4%

Midwest region                              0.001585        6,309       
5.3%

Southern region                             0.001440        6,944       
4.8%

Western region                              0.001615        6,192       
5.4%

Hispanics                                   0.001691        5,913       
5.6%

Non-hispanic whites                         0.001519        6,585       
5.1%

Non-hispanic blacks                         0.001521        6,574       
5.1%

Non-hisp/non-white/non-black                0.001771        5,648       
5.9%

All infants (< 1 year)                      0.003081        3,246      
10.3%

Nursing infants                             0.001503        6,653       
5.0%

Non-nursing infants                         0.003680        2,717      
12.3%

Children 1-6  yrs                           0.004001        2,500      
13.3%

Children 7-12 yrs                           0.002170        4,609       
7.2%

Females 13-19 (not preg or nursing)         0.001321        7,571       
4.4%

Females 20+ (not preg or nursing)           0.001095        9,132       
3.7%

Females 13-50 yrs                           0.001252        7,989       
4.2%

Females 13+ (preg/not nursing)              0.001343        7,448       
4.5%

Females 13+ (nursing)                       0.001469        6,807       
4.9%

Males 13-19 yrs                             0.001507        6,637       
5.0%

Males 20+ yrs                               0.001158        8,634       
3.9%

Seniors 55+                                 0.001064        9,398       
3.5%

Children 1-2 yrs                            0.004749        2,106      
15.8%

Children 3-5 yrs                            0.003819        2,618      
12.7%

Children 6-12 yrs                           0.002304        4,341       
7.7%

Youth 13-19 yrs                             0.001417        7,057       
4.7%

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

Pendimethalin	Dietary Exposure Assessment	DP Num: 	334173

PC Code:  108501			Page   PAGE  1  of   NUMPAGES  11 

DRAFT Confidential, Internal, and Deliberative Material

Pendimethalin	Dietary Exposure Assessment	DP Num: 	334173

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