### Pyrimethanil Dietary Exposure and Risk Assessment DP# 38998 6

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## I. Introduction

Dietary risk assessment incorporates both exposure and toxicity of a given pesticide. For acute

and chronic (non

- cancer) assessments, the risk is expressed as a percentage of a maximum

acceptable dose ( i.e., the dose which HED has concluded will result in no

- unreasonable

- adverse

health

– effects, NOAEL). This dose is referred to as the PAD. The PAD is equivalent to the

point of departure (POD, NOAEL, LOAEL) divided by the required uncertainty factors (UFs).

For acute and chronic (n on

- cancer) exposures, HED is concerned when estimated dietary risk

exceeds 100% of the PAD for acute and non

- cancer chronic assessment. 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

s ee SOP 99.6 (20

- AUG

- 1999).

II. Residue Information

Pyrimethanil tolerances are published in 40 CFR §180.518

.

Residues of Concern in Plants and Livestock: Table 1 is a summary of the HED Metabolism

Assessment Review Committee (MARC) decisions concerning the residues of concern in plants,

ruminants, and milk for tolerance expression and risk assessment purposes ( D P# 248001, J.

Morales, 1/12/04).

Table 1. Residues of Concern in Plants and Ruminants.

Matrix Residues of Concern

For Risk Assessment For Tolerance Expression

Plants Parent Only Parent Only

Ruminant Parent + AEC614276 Parent + AEC614276

Milk Parent + AEC614277 Parent + AEC614277



## Recommended Tolerances : Interregional Research Project No. 4 (IR

- 4) has proposed new

tolerances for residues of pyrimethanil

. As part of the current petition, HED recommends

establishing the following tolerances :

Ginseng

................................ ................................ ................................ ........... 1.5 ppm

Onion, bulb subgroup 3

- 07A

................................ ................................ ......... 0. 2 0 ppm

Onion, green subgroup 3

- 07B

................................ ................................ ........ 3 .0 ppm

Fruit, small, vine climbing, subgroup 13

- 07F, except fuzzy kiwifruit

........... 5.0 ppm

Low growing berry subgroup 13

- 07G

................................ ............................ 3.0 ppm

No new data were submitted to support tolerances on onion, bulb, subgroup 3

- 07A ; onion, green,

subgroup 3

- 07B; low

- growing berry 13

- 07G crop subgroup; or small fruit vine climbing

subgroup 13

- 07F, except fuzzy kiwifruit. The petitioner has requested that existing tolerances be

expanded to their respective crops or crop groups.

### Pyrimethanil Dietary Exposure and Risk Assessment DP# 38998 6

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## Food R esidues and processing factors used in the Acute and Chronic Analysis: The acute and

chronic analyses assumed DEEM (ver. 7.81) default processing factors (as necessary),

empirical processing factors for orange and apple juice, tolerance

- level residues, a nd 100% CT

for all commodities. The empirical processing factors for orange juice (0.007) and apple juice

(0.35) can be found in D P# 248001 ( PP #s 2F6439 & 2F6480

, J. Morales , 1/12/04 ).

III. Drinking Water Data

Environment Fate and Effects Division (EFED) studies indicated that pyrimethanil is expected to

be moderately persistent in the environment. Aerobic metabolism is expected to be the major

route of degradation for pyrimethanil in the environment. The only major degradate is 2

- amino

4,6

- dimethylpyri midine (degradate 1). Although it may be less toxic than the parent, degradate 1

is expected to be more mobile and more persistent in the environment than the parent. MARC

recommended that parent and degradate 1 are the residues of concern for drinking w ater.

EFED provided Tier 1 EDWC s for ground water (SCI

- GROW), and Tier 2 EDWCs for surface

water (PRZM/EXAMS) for pyrimethanil and its major metabolite (2

- amino

- 4,6

- dimethylpyrimidine), for use in the human

- health risk assessment. The models and their

descriptions are available at the EPA internet site: http://www.epa.gov/oppefed1/models/water/

.

EFED reassessed pyrimethanil for the proposed new uses presented in this memo (D P# 389925

, J. Wolf

, 9/ 2 6 / 11 ) . Tier I SCI

- GROW screening concentration of combined total residues

( p yrimethanil + 2

- a mino

- 4,6

- dimethylpyrimidine) in ground water for uses on small berries

(caneberries and bushberries) are not expected to exceed 4.8 μg/L for previously estimated uses

based on the registered seasonal application rate of 2.1 lb ai/A on strawberry in Florida (DP#

283999 and 290313, 10/22/03; D P# 353180, 01/08/09 ).

Tier II PRZM

- EXAMS screening drinking water concentrations for combined resi dues of

pyrimethanil (parent + 2

- amino

- 4,6

- dimethylpyrimidine) in raw surface source water are not

expected to exceed 86

. 5 μg/L for the peak 1

- in

- 10

- year concentration; 2 9. 4 μg/L for the 1

- in

- 10

- year annual mean concentration; and, 1 7.9 μg/L for the 30

- yea r annual average concentration.

These EDWC s correspond to the FL/strawberries (acute) and NY/grapes (chronic) scenarios

.

Table 2

. Estimated Drinking Water Concentrations for Combined Total Residues, Parent (Pyrimethanil)

Plus Major Degradate (2

- amino

- 4, 6

- dimethylpyrimidine).

Chemical Acute (peak)

Surface Water

Concentration

(ppb) Annual Average

Surface Water

Concentration

1

- in

- 10

- yr (ppb) Average of

Annual Average

Surface Water

Concentration

(ppb) Ground Water

Concentration

(ppb)

Pyrimethanil plus

2

- amino

- 4,6

- dimethylpyrimidine. 86.5 29.4 17.9 4.8



## In this assessment, the annual average surface water concentration ( 29.4 ppb) and the acute peak

surface water concentrations ( 86.5 ppb) were used for chronic and acute dietary exposure

assessments, respectively.

### Pyrimethanil Dietary Exposure and Risk Assessment DP# 38998 6

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## IV. DEEM

- FCID Program and Consumption Information

Pyrimethanil acute and chronic dietary exposure assessments were conducted using the DEEM

FCID (ver. 2.03), which incorporates consumption data from USDA’s CSFII (1994

- 1996 and

1998). The 1994

- 96 and 98 data are based on the reported consumption of more than 20,000

individuals over two non

- consecutive survey days. Foods “as consumed” ( i.e.

, apple pie) are

linked to EPA

- defined food commodities ( i.e.

, 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 years

old, children 3

- 5 years old, children 6

- 12 years old, youth 13

- 19 years old, adults 20

- 49 years

old, females 13

- 49 years old, and adults 50+ years old.

For the chronic dietary exposure assessment, an estimate of the residue level in each food or

food

- form ( i.e.

, orange o r 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 expo sure 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 exposur e 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.

, t hose 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 leve ls ( tiers ) of analysis. However, for unrefined and

partially refined assessments ( Tiers 1 and 2 ) , significant differences in user vs. per capita

exposure and risk are identified and noted in the risk assessment.

V. Toxicological Information

The HIARC met on April 24, 2003 to determine endpoint selection for pyrimethanil. At this

meeting, the HIARC also evaluated the potential for increased susceptibility of infants and

children from exposure to pyrimethanil as required by the Food Quality Pr otection Act (FQPA)

of 1996 (TXR No. 0052257, 12/2/03). The Cancer Peer Review Committee (CPRC) evaluated

the data on pyrimethanil on 5/29/96 and concluded that pyrimethanil should be classified as

Group C

- possible human carcinogen

- and recommended tha t MOE methodology be used for

the estimation of human risk (TXR # 0050189, 2/11/97). However, newly submitted toxicology

data have resulted a change in cancer classification to “not likely to be carcinogenic to humans”

### Pyrimethanil Dietary Exposure and Risk Assessment DP# 38998 6

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## (Memo, J. Tyler et al. , D 389923 ). T able 3 is a summary of the decisions made by the HIARC

concerning dietary exposure assessment.

Based on toxicological considerations (evaluated by HIARC) and the residue assumptions used

in the dietary analyses (evaluated by the risk assessment team; RA B1/HED), it was concluded

that the FQPA Safety Factor should be reduced to 1x when assessing dietary exposure to

pyrimethanil.

Table 3. Summary of Toxicological Doses and Endpoints for Pyrimethanil for Use in Dietary Exposure Risk

Assessments.

Exposure/

Scenario Point of

Departure Uncertainty/FQPA

Safety Factors RfD, PAD, Level of

Concern Study and Toxicological Effects

Acute Dietary

(Females 13

- 49 years of

age) NOAEL =

45

mg/kg/day UF A 

### = 10x

UF H 

### = 10x

FQPA SF = 1x Acute RfD = 0.45

mg/kg/day

aPAD = 0.45

mg/kg/day Developmental Toxicity

- Rabbit :

LOAEL = 300 mg/kg/day based on

increases in fetuses with 13 thoracic

vertebrae and 13 pairs of ribs.

Acute Dietary

(General

Population

, including

Infants and

Children) NOAEL =

100

mg/kg/day UF A 

### = 10x

UF H 

### = 10x

FQPA SF = 1x Acute RfD = 1

mg/kg/day Acute Neurotoxicity

- Rat:

LOAEL = 1000 mg/kg/day based on

decreased motor activity, ataxia,

decreased body temperature, hind

limb grip strength, and dilated pupils.

Chronic

Dietary (All

Populations) NOAEL =

17

mg/kg/day UF A 

### = 10x

UF H 

### = 10x

FQPA SF = 1x Chronic RfD = 0.17

mg/kg/day

cPAD = 0.17

mg/kg/day Chronic Toxicity

- Rat:

LOAEL = 221 mg/kg/day based on

decreased body weight gains;

increased serum cholesterol and GGT,

increased relative liver/bo dy weight

ratios, necropsy and histopathological

findings in the liver and thyroid.

Cancer (oral, dermal,

inhalation) In accordance with the EPA’s Final Guidelines for Carcinogen Risk Assessment

(March 2005), the CARC classified pyrimethanil as “ Not Likely To Be Carcinogenic

To Humans At Doses That Do Not Alter Rat Thyroid Hormone Homeostasis”

(TXR#0056151, J. Rowland, 12/ 23 / 12).

Point of Departure (POD) = A data point or an estimated point that is derived from observed dose

- response data and

used t o 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. UF A 

### = extrapolation from animal to human (intraspecies). UF H 

### = potential variation in

sensitivity among members of the human population (interspecies ). FQPA SF = FQPA Safety Factor. PAD =

population

- adjusted dose (a = acute, c = chronic). RfD = reference dose. MOE = mar gin of exposure.



## VI. Results/Discussion

As stated above, for acute and chronic assessments, HED is concerned when dietary risk exceeds

100% of the aPAD or cPAD, respectively. The following paragraphs are summaries of the

DEEM

- FCID (ver. 2.03) acute and chronic exposure analyses.

Acute and chronic aggregate (food + water) analyses were performed using DEEM

- FCID

estimating the dietary exposure of the U.S. population and various population subgroups. The

results are summarized in Tables 4 and 5 below for acute and chronic analyses respectively.

The resulting acute food and drinking water risk estimates are not of concern to HED (<100%

aPAD) at the 95 th 

## percentile of the exposure distribution for the U

. S

. general population and all

### Pyrimethanil Dietary Exposure and Risk Assessment DP# 38998 6

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Page 7 of 20 

## population subgroups (≤35 % aPAD) ; the most highly exposed population subgroup is all infants

<1 year old. The resulting chronic food and drinking water risk estimates are not of concern to

HED (<100% cPAD) for U.S. general population and all population subgroups (≤6 4 % cPAD) ;

the most highly exposed population subgroup is children 1

- 2 years old.

Table 4. Summary of Acute Dietary Exposure & Risk for Pyrimethanil at the95 th 

### Percentile.

Population Subgroup aPAD (mg/kg/day) Exposure (mg/kg/day) %aPAD

General U.S. Population

1.0 0.098872 9.9

All Infants (< 1 year old) 0.349561 3 5

Children 1

- 2 years old 0.349561 3 4

Children 3

- 5 years old 0.246781 2 5

Children 6

- 12 years old 0.129627 1 3

Youth 13

- 19 years old 0.061678 6

. 2

Adults 20

- 49 years old 0.054748 5 .5

Adults 50+ years old 0.064706 6 .5

Females 13

- 49 years old 0.45 0.059322 1 3

*Population subgroup with the highest exposure and risk is in bold type

.

Table 5. Summary of Chronic Dietary Exposure and Risk for Pyrimethanil.

Population Subgroup cPAD (mg/kg/day) Exposure (mg/kg/day) %cPAD

General U.S. Population

0.17 0.023155 1 4

All Infants (<1 year old) 0.092221 54

Children 1

- 2 years old 0.108087 6 4

Children 3

- 5 years old 0.074796 44

Children 6

- 12 years old 0.034198 20

Youth 13

- 19 years old 0.013698 8

. 1

Adults 20

- 49 years old 0.012575 7 .4

Adults 50+ years old 0.017041 10

Females 13

- 49 years old 0.013724 8 .1

*Population subgroup with the highest exposure and risk is in bold type

.



## VII. Characterization of Inputs/Outputs

These chronic dietary exposure and risk estimates are conservative since they assume that 100%

of crops are treated with pyrimethanil and that residues are present at tolerance levels. In

addition, drinking water exposure estimates were based on screening level estimates generated

by the PRZM/EXAMS water model . Dietary exposure estimates could be refined through the

use of anticipated residues and percent crop treated data, as well as refined estimated drinking

water concentrations. However, since estimated exposures and risks using conservative

assumptions are well below HED ’s level of concern, such refinement is not warranted.

VIII. Conclusions

Th e unrefined dietary exposure a ssessment using DEEM

- FCID TM 

## indicates that both acute and

chronic dietary food + drinking water exposure s to pyrimetha n il are below HED ’s level of

concern for this pesticide. The resulting acute food and drinking water risk estimates are <100%

### Pyrimethanil Dietary Exposure and Risk Assessment DP# 38998 6

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Page 8 of 20 

## aPAD at the 95 th 

## percentile of the exposure distribution for the U

. S

. general population and all

population subgroups (≤35% aPAD) ; the most highly exposed population subgroup is all infants

<1 year old. The chronic food and drinking water risk estimates are <100% cPAD for U.S.

general population and all population subgroups (≤64% cPAD) ; the most highly exposed

population subgroup is children 1

- 2 years old.

IX. List of Attachments

Attachment 1: Acute Food plus Water Residue Input File

Attachment 2: Acute Results File

Attachment 3 : Chronic Food plus Water Residue Input File

Attachment 4 : Chronic Results File

cc: G. Kramer

G.F. Kramer:S10957:PY

- S:(703)305

- 5079:7509P:RAB1

### Pyrimethanil Dietary Exposure and Risk Assessment DP# 38998 6

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## Attachment 1: DEEM

- FCID Acute Residue File

Filename: C: \ Documents and Settings \ gkramer \ My Documents \ Gk \ #Pyrimethanil \ 288201a.R98

Chemical: Pyrimethanil

RfD(Chronic): .17 mg/kg bw/day NOEL(Chronic): 17 mg/kg bw/day

RfD(Acute): 1 mg/kg bw/day NOEL(Acute): 100 mg/kg bw/day

Date created/last modified: 04

- 26

- 2012/15:13:32/8 Program ver. 2.03

Comment: FQPA SF 1X for all endpoints; cPAD for all populations is 0.17 mg/kg/day

------------------------------- ------------------------------------------------- EPA Crop Def Res Adj.Factors Comment

Code Grp Commodity Name (ppm) #1 #2

-------- ---- ------------------------------- ---------- ------ ------ ------- 01011680 1AB Ginseng, dried 1.500000 1.000 1.000

01030150 1CD Arrowroot, flour 0.050000 1.000 1.000 D28400

Full comment: D284001

01030151 1CD Arrowroot, flour

- ba byfood 0.050000 1.000 1.000 D28400

Full comment: D284001

01030170 1CD Artichoke, Jerusalem 0.050000 1.000 1.000 D28400

Full comment: D284001

01030820 1CD Cassava 0.050000 1.0 00 1.000 D28400

Full comment: D284001

01030821 1CD Cassava

- babyfood 0.050000 1.000 1.000 D28400

Full comment: D284001

01031390 1CD Dasheen, corm 0.050000 1.000 1.000 D28400

Fu ll comment: D284001

01031660 1CD Ginger 0.050000 1.000 1.000 D28400

Full comment: D284001

01031661 1CD Ginger

- babyfood 0.050000 1.000 1.000 D28400

Full comment: D284001

01031670 1 CD Ginger, dried 0.050000 1.000 1.000 D28400

Full comment: D284001

01032960 1C Potato, chips 0.050000 1.000 1.000 D28400

Full comment: D284001

01032970 1C Potato, dry (granules/ fla kes) 0.050000 6.500 1.000 D28400

Full comment: D284001

01032971 1C Potato, dry (granules/ flakes)

- b 0.050000 6.500 1.000 D28400

Full comment: D284001

01032980 1C Potato, flour 0.050000 1.000 1.0 00 D28400

Full comment: D284001

01032981 1C Potato, flour

- babyfood 0.050000 1.000 1.000 D28400

Full comment: D284001

01032990 1C Potato, tuber, w/peel 0.050000 1.000 1.000 D28400

Full comment: D284001

01032991 1C Potato, tuber, w/peel

- babyfood 0.050000 1.000 1.000 D28400

Full comment: D284001

01033000 1C Potato, tuber, w/o peel 0.050000 1.000 1.000 D28400

Full comment: D28400 1

01033001 1C Potato, tuber, w/o peel

- babyfood 0.050000 1.000 1.000 D28400

Full comment: D284001

01033660 1CD Sweet potato 0.050000 1.000 1.000 D28400

Full comment: D284001

01033661 1CD Sweet potato

- b abyfood 0.050000 1.000 1.000 D28400

Full comment: D284001

01033710 1CD Tanier, corm 0.050000 1.000 1.000 D28400

Full comment: D284001

01033870 1CD Turmeric 0.050000 1.000 1.000 D28400

Full comment: D284001

01034060 1CD Yam, true 0.050000 1.000 1.000 D28400

Full comment: D284001

01034070 1CD Yam bean 0.050000 1.000 1.000 D28400

Full comment: D284001

03001640 3 Garlic 0.200000 1.000 1.000

03001650 3 Garlic, dried 0.200000 1.000 1.000

03001651 3 Garlic, dried

- babyfood 0.200000 1.000 1.000

030019 80 3 Leek 3.000000 1.000 1.000

03002370 3 Onion, dry bulb 0.200000 1.000 1.000 D28400

Full comment: D284001

03002371 3 Onion, dry bulb

- babyfood 0.200000 1.000 1.000 D28400

Full comment: D284001

03002380 3 Onion, dry bulb, dried 0.200000 9.000 1.000 D28400

### Pyrimethanil Dietary Exposure and Risk Assessment DP# 38998 6

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Page 10 of 20 Full comment: D284001

03002381 3 Onion, dry bulb, dried

- babyfood 0.200000 9.000 1.000 D28400

Full comment: D284001

03002390 3 Onion, green 3.000000 1.000 1.000 D28400

Full comment: D284001

03003380 3 Shallot 3.000000 1.000 1.000

08003750 8 Tomato 0.500000 1.000 1.000 D28400

Full comment: D284001

08003751 8 Tomato

- babyfood 0.500000 1.000 1.000 D28400

Full comment: D284001

08003760 8 Tomato, paste 0.500000 5.400 1.000 D28400

Full comment: D284001

08003761 8 Tomato, paste

- babyfood 0.500000 5.400 1.000 D28400

Full comment: D284001

08003770 8 Tomato, puree 0.500000 3.300 1.000 D28400

Full comment: D284001

080037 71 8 Tomato, puree

- babyfood 0.500000 3.300 1.000 D28400

Full comment: D284001

08003780 8 Tomato, dried 0.500000 14.300 1.000 D28400

Full comment: D284001

08003781 8 Tomato, dried

- babyfood 0.500000 14.300 1.000 D28400

Full comment: D284001

08003790 8 Tomato, juice 0.500000 1.500 1.000 D28400

Full comment: D284001

10001060 10 Citrus citron 10.000000 1.000 1.000 D28400

Full comment: D284001

10001070 10 Citrus hybrids 10.000000 1.000 1.000 D28400

Full comment: D284001

10001080 10 Citrus, oil 150.000000 1.000 1.000 D28400

Full comment: D284001

10001800 10 Grapefruit 10.000000 1.000 1.000 D28400

Full comment: D284001

10001810 10 Grapefruit, juice 10.000000 2.100 1.000 D28400

Full comment: D28400 1

10001970 10 Kumquat 10.000000 1.000 1.000 D28400

Full comment: D284001

10001990 10 Lemon 11.000000 1.000 1.000 8E7353

Full comment: 8E7353 Proposed Tolerance 2009

10002 000 10 Lemon, juice 11.000000 2.000 1.000 8E7353

Full comment: 8E7353 Proposed Tolerance 2009

10002001 10 Lemon, juice

- babyfood 11.000000 2.000 1.000 8E7353

Full comment: 8E7353 Proposed Tole rance 2009

10002010 10 Lemon, peel 11.000000 1.000 1.000 8E7353

Full comment: 8E7353 Proposed Tolerance 2009

10002060 10 Lime 10.000000 1.000 1.000 D28400

Full comment: D284 001

10002070 10 Lime, juice 10.000000 2.000 1.000 D28400

Full comment: D284001

10002071 10 Lime, juice

- babyfood 10.000000 2.000 1.000 D28400

Full comment: D284001

10002400 10 Orange 10.000000 1.000 1.000 D28400

Full comment: D284001

10002410 10 Orange, juice 10.000000 0.007 1.000 D28400

Full comment: D284001

10002411 10 Orange, juice

- babyfood 10.00000 0 0.007 1.000 D28400

Full comment: D284001

10002420 10 Orange, peel 10.000000 1.000 1.000 D28400

Full comment: D284001

10003070 10 Pummelo 10.000000 1.000 1.000 D28400

Full comment: D284001

10003690 10 Tangerine 10.000000 1.000 1.000 D28400

Full comment: D284001

10003700 10 Tangerine, juice 10.000000 2.300 1.000 D28400

Full comment: D28400 1

11000070 11 Apple, fruit with peel 14.000000 1.000 1.000 DP# 34

Full comment: DP# 347248

11000080 11 Apple, peeled fruit 14.000000 1.000 1.000 DP# 34

Full comment: DP# 347248

11000081 11 Apple, peeled fruit

- babyfood 14.000000 1.000 1.000 DP# 34

Full comment: DP# 347248

11000090 11 Apple, dried 14.000000 8.000 1.000 DP# 34

### Pyrimethanil Dietary Exposure and Risk Assessment DP# 38998 6

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Page 11 of 20 Full comment: DP# 347248

11000091 11 Apple, dried

- babyfood 14.000000 8.000 1.000 DP# 34

Full comment: DP# 347248

11000100 11 Apple, juice 14.000000 0.350 1.000 DP# 34

Full comment: DP# 347248

11000101 11 Apple, juice

- babyfood 14.000000 0.35 0 1.000 DP# 34

Full comment: DP# 347248

11000110 11 Apple, sauce 14.000000 1.000 1.000 DP# 34

Full comment: DP# 347248

11000111 11 Apple, sauce

- babyfood 14.000000 1.000 1.000 DP# 34

Full comment: DP# 347248

11001290 11 Crabapple 14.000000 1.000 1.000 DP# 34

Full comment: DP# 347248

11002100 11 Loquat 14.000000 1.000 1.000 DP# 34

Full comment: DP# 347248

11002660 11 Pear 14.000000 1.000 1.000 DP# 34

Full comment: DP# 347248

11002661 11 Pear

- babyfood 14.000000 1.000 1.000 DP# 34

Full comment : DP# 347248

11002670 11 Pear, dried 14.000000 6.250 1.000 DP# 34

Full comment: DP# 347248

11002680 11 Pear, juice 14.000000 1.000 1.000 DP# 34

Full comment: DP# 347248

11002681 11 Pear, juice

- babyfood 14.000000 1.000 1.000 DP# 34

Full comment: DP# 347248

11003100 11 Quince 14.000000 1.000 1.000 DP# 34

Full comment: DP# 347248

12000120 12 Apricot 10.000000 1.000 1.000 8E7353

Full comment: 8E7353 Proposed Tolerance 2009

12000121 12 Apricot

- babyfood 10.000000 1.000 1.000 8E7353

Full comment: 8E7353 Proposed Tolerance 2009

12000130 12 Apricot, dried 10.000000 6.000 1.000 8E7353

Full comment: 8E7353 Proposed Tolerance 2009

12000140 12 Apricot, juice 10.000000 1.000 1.000 8E7353

Full comment: 8E7353 Proposed Tolerance 200 9

12000141 12 Apricot, juice

- babyfood 10.000000 1.000 1.000 8E7353

Full comment: 8E7353 Proposed Tolerance 2009

12000900 12 Cherry 10.000000 1.000 1.000 8E7353

Full comment: 8E7353 Propos ed Tolerance 2009

12000901 12 Cherry

- babyfood 10.000000 1.000 1.000 8E7353

Full comment: 8E7353 Proposed Tolerance 2009

12000910 12 Cherry, juice 10.000000 1.500 1.000 8E7353

Full comment: 8E7353 Proposed Tolerance 2009

12000911 12 Cherry, juice

- babyfood 10.000000 1.500 1.000 8E7353

Full comment: 8E7353 Proposed Tolerance 2009

12002300 12 Nectarine 10.000000 1.000 1.000 8E7353

Full comment: 8E7353 Proposed Tolerance 2009

12002600 12 Peach 10.000000 1.000 1.000 8E7353

Full comment: 8E7353 Proposed Tolerance 2009

12002601 12 Peach

- babyfood 1 0.000000 1.000 1.000 8E7353

Full comment: 8E7353 Proposed Tolerance 2009

12002610 12 Peach, dried 10.000000 7.000 1.000 8E7353

Full comment: 8E7353 Proposed Tolerance 2009

12002611 12 Peach, dried

- babyfo od 10.000000 7.000 1.000 8E7353

Full comment: 8E7353 Proposed Tolerance 2009

12002620 12 Peach, juice 10.000000 1.000 1.000 8E7353

Full comment: 8E7353 Proposed Tolerance 2009

12002621 12 Pea ch, juice

- babyfood 10.000000 1.000 1.000 8E7353

Full comment: 8E7353 Proposed Tolerance 2009

12002850 12 Plum 10.000000 1.000 1.000 8E7353

Full comment: 8E7353 Proposed Tolerance 2009

1 2002851 12 Plum

- babyfood 10.000000 1.000 1.000 8E7353

Full comment: 8E7353 Proposed Tolerance 2009

12002860 12 Plum, prune, fresh 10.000000 1.000 1.000 8E7353

Full comment: 8E7353 Proposed Tolerance 2009

12002861 12 Plum, prune, fresh

- babyfood 10.000000 1.000 1.000 8E7353

Full comment: 8E7353 Proposed Tolerance 2009

12002870 12 Plum, prune, dried 10.000000 5.000 1.000 8E7353

Full comment: 8E7353 Proposed Tolerance 2009

12002871 12 Plum, prune, dried

- babyfood 10.000000 5.000 1.000 8E7353

Full comment: 8E7353 Proposed Tolerance 2009

### Pyrimethanil Dietary Exposure and Risk Assessment DP# 38998 6

_____________________________________________________________________________________________

Page 12 of 20 12002880 12 Plum, prune, juice 10.000000 1.400 1.000 8E7353

Full comment: 8E7353 Proposed Tolerance 2009

12002881 12 Plum, prune, juice

- babyfood 10.000000 1.400 1.000 8E7353

Full comment: 8E7353 Proposed Tolerance 2009

13010550 13A Blackberry 12.000000 1.000 1.000

13010560 13A Blackberry, juice 12.000000 1.000 1.000

13010561 13A Blackberry, juice

- babyfood 12.000000 1.000 1.000

13010580 13A Boysenberry 12.000000 1.000 1.000

13011420 13A Dewberr y 12.000000 1.000 1.000

13012080 13A Loganberry 12.000000 1.000 1.000

13013200 13A Raspberry 12.000000 1.000 1.000

13013201 13A Raspberry

- babyfood 12.0 00000 1.000 1.000

13013210 13A Raspberry, juice 12.000000 1.000 1.000

13013211 13A Raspberry, juice

- babyfood 12.000000 1.000 1.000

13020570 13B Blueberry 6.000000 1.000 1.000

13020571 13B Blueberry

- babyfood 6.000000 1.000 1.000

13021360 13B Currant 6.000000 1.000 1.000

13021370 13B Currant, dried 6.000000 1.000 1.000

13021490 13B Elderberry 6.000000 1.000 1.000

13021740 13B Gooseberry 6.000000 1.000 1.000

13021910 13B Huckleberry 6.000000 1.000 1.000

14000030 14 Almond 0.200000 1.000 1.0 00 D28400

Full comment: D284001

14000031 14 Almond

- babyfood 0.200000 1.000 1.000 D28400

Full comment: D284001

14000040 14 Almond, oil 0.200000 1.000 1.000 D28400

Full comm ent: D284001

14000041 14 Almond, oil

- babyfood 0.200000 1.000 1.000 D28400

Full comment: D284001

14002820 14 Pistachio 0.200000 1.000 1.000

21000440 M Beef, meat 0.010000 1.000 1.000 D28400

Full comment: D284001

21000441 M Beef, meat

- babyfood 0.010000 1.000 1.000 D28400

Full comment: D284001

21000450 M Beef, meat, dried 0.010000 1.920 1.000 D2840 0

Full comment: D284001

21000460 M Beef, meat byproducts 0.010000 1.000 1.000 D28400

Full comment: D284001

21000461 M Beef, meat byproducts

- babyfood 0.010000 1.000 1.000 D28400

Full comment: D284 001

21000470 M Beef, fat 0.010000 1.000 1.000 D28400

Full comment: D284001

21000471 M Beef,fat

- babyfood 0.010000 1.000 1.000 D28400

Full comment: D284001

21000480 M Beef, kidney 2.500000 1.000 1.000 DP# 34

Full comment: DP# 347248

21000490 M Beef, liver 0.010000 1.000 1.000 D28400

Full comment: D284001

21000491 M Beef, liver

- babyfood 0.01 0000 1.000 1.000 D28400

Full comment: D284001

23001690 M Goat, meat 0.010000 1.000 1.000 D28400

Full comment: D284001

23001700 M Goat, meat byproducts 0.010000 1.000 1.000 D28400

Full comment: D284001

23001710 M Goat, fat 0.010000 1.000 1.000 D28400

Full comment: D284001

23001720 M Goat, kidney 2.500000 1.000 1.000 DP# 34

Full comment: DP# 3472 48

23001730 M Goat, liver 0.010000 1.000 1.000 D28400

Full comment: D284001

24001890 M Horse, meat 0.010000 1.000 1.000 D28400

Full comment: D284001

26003390 M Sheep, meat 0.010000 1.000 1.000 D28400

Full comment: D284001

26003391 M Sheep, meat

- babyfood 0.010000 1.000 1.000 D28400

Full comment: D284001

26003400 M Sheep, meat byproducts 0.010000 1.000 1.000 D28400

Full comment: D284001

26003410 M Sheep, fat 0.010000 1.000 1.000 D28400

Full comment: D284001

26003411 M Sheep, fat

- babyfood 0.010000 1.000 1.000 D28400

### Pyrimethanil Dietary Exposure and Risk Assessment DP# 38998 6

_____________________________________________________________________________________________

Page 13 of 20 Full comment: D284001

26003420 M Sheep, kidney 2.500000 1.000 1.000 DP# 34

Full comment: DP# 347248

26003430 M Sheep, liver 0.010000 1.000 1.000 D28400

Full comment: D284001

2 7002220 D Milk, fat 0.050000 1.000 1.000 DP# 34

Full comment: DP# 347248

27002221 D Milk, fat

- baby food/infant for 0.050000 1.000 1.000 DP# 34

Full comment: DP# 347248

27012230 D Milk, nonfa t solids 0.050000 1.000 1.000 DP# 34

Full comment: DP# 347248

27012231 D Milk, nonfat solids

- baby food/in 0.050000 1.000 1.000 DP# 34

Full comment: DP# 347248

27022240 D Milk, water 0.050000 1.000 1.000 DP# 34

Full comment: DP# 347248

27022241 D Milk, water

- babyfood/infant form 0.050000 1.000 1.000 DP# 34

Full comment: DP# 347248

27032251 D Milk, sugar (lactose)

- baby food/ 0.050000 1.000 1.000 DP# 34

Full comment: DP# 347248

86010000 O Water, direct, all sources 0.086500 1.000 1.000 USEPA

Full comment: USEPA EFED memo 9

- 26

- 2011

86020000 O Water, indirect, all sources 0.086500 1.000 1.000 USEPA

Full comment: USEPA EFED memo 9

- 26

- 2011

95000230 O Banana 0.100000 1.000 1.000

95000231 O Banana

- babyfood 0.100000 1.000 1.000

95000240 O Banana, dried 0.100000 3.900 1.000

95000241 O Banana, dried

- babyfood 0.100000 3.900 1.000

95001300 O Cranberry 3.000000 1.000 1.000

95001301 O Cranberry

- babyfood 3.000000 1.000 1.000

95001310 O Cranberry, dried 3.000000 1.000 1.000

95001320 O Cranberry, juice 3.000000 1.000 1.000

95001321 O Cranberry, juice

- babyfood 3.000000 1.000 1.000

95001750 O Grape 5.000000 1.000 1.000 D28400

Full comment: D284001

95001760 O Grape, juice 5.000000 1.200 1.000 D28400

Full comment: D284001

95001761 O Grape, juice

- babyfood 5.000000 1.200 1.000 D28400

Full comment: D284001

95001770 O Grape, leaves 5.000000 1.000 1.000 D28400

Full comment: D284001

95001780 O Grape, raisin 8.000000 1.000 1.000 D28400

Full comment: D284001

95001790 O Grape, wine and sherry 5.000000 1.000 1.000 D28400

Full comment: D284001

95002830 O Plantain 0.100000 1.000 1.000

95002840 O Plantain, dried 0.100000 3.900 1.000

95003590 O Strawberry 3.000000 1.000 1.000 D28400

Full comment: D284001

95003591 O Strawberry

- babyfood 3.000000 1.000 1 .000 D28400

Full comment: D284001

95003600 O Strawberry, juice 3.000000 1.000 1.000 D28400

Full comment: D284001

95003601 O Strawberry, juice

- babyfood 3.000000 1.000 1.000 D28400

Full co mment: D284001

### Pyrimethanil Dietary Exposure and Risk Assessment DP# 38998 6

_____________________________________________________________________________________________

Page 14 of 20 

## Attachment 2: DEEM

- FCID Acute Exposure Estimates

U.S. Environmental Protection Agency Ver. 2.02

DEEM

- FCID ACUTE Analysis for PYRIMETHANIL (1994

- 98 data)

Residue file: 288201a.R98 Adjustment factor #2 used.

Analysis Date: 05

- 02

- 2012/13:51:47 Residue file dated: 04

- 26

- 2012/15:13:32/8

NOEL (Acute) = 100.000000 mg/kg body

- wt/day

Daily totals for food and foodform consumption used.

Run Comment: "FQPA SF 1X for all endpoints; cPAD for all populations is 0.17 m

g/kg/day"

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

Summary calculations (per capita):

95th Percentile 99th Percentile 99.9th Percentile

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

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

U.S. Pop ulation:

0.098872 9.89 1011 0.233604 23.36 428 0.483225 48.32 206

All infants:

0.349561 34.96 286 0.613137 61.31 163 1.467904 146.79 68

Children 1

- 2 yrs:

0.337659 33.77 296 0.533403 53.34 187 0.844637 84.46 118

Children 3

- 5 yrs:

0.246781 24.68 405 0.374940 37.49 266 0.609225 60.92 164

Children 6

- 12 yrs:

0.129627 12.96 771 0.222356 22.24 449 0.365146 36.51 273

Youth 13

- 1 9 yrs:

0.061678 6.17 1621 0.111304 11.13 898 0.210156 21.02 475

Adults 20

- 49 yrs:

0.054748 5.47 1826 0.092573 9.26 1080 0.188615 18.86 530

Adults 50+ yrs:

0.064706 6.47 1545 0.113199 11.3 2 883 0.219612 21.96 455

Females 13

- 49 yrs:

0.059322 5.93 1685 0.100600 10.06 994 0.167568 16.76 596

### Pyrimethanil Dietary Exposure and Risk Assessment DP# 38998 6

_____________________________________________________________________________________________

Page 15 of 20 

## Attachment 3: DEEM

- FCID Chronic Residue File

Filename: C: \ Documents and Settings \ gkramer \ My Documents \ Gk \ #Pyrimethanil \ 288201c.R98

Chemical: Pyrimethanil

RfD(Chronic): .17 mg/kg bw/day NOEL(Chronic): 17 mg/kg bw/day

RfD(Acute): 1 mg/kg bw/day NOEL(Acute): 100 mg/kg bw/day

Date created/last modified: 04

- 26

- 2012/15:27:50/8 Program ver. 2.03

Comment: FQPA SF 1X for all endpoints; cPAD for all populations is 0.17 mg/kg/day

-------------------------------------------------------------------------------- EPA Crop Def Res Adj.Factors Comment

Code Grp Commodity Name (ppm) #1 #2

-------- ---- ------------------------------- ---------- ------ ------ ------- 01011680 1AB Ginseng, dried 1.500000 1.000 1.000

01030150 1CD Arrowroot, flour 0.050000 1.000 1.000 D28400

Full comment: D284001

01030151 1CD Arrowroot, flour

- babyfood 0.050000 1.000 1.000 D28400

Full comment: D284001

01030170 1CD Artichoke, Jerusalem 0.050000 1. 000 1.000 D28400

Full comment: D284001

01030820 1CD Cassava 0.050000 1.000 1.000 D28400

Full comment: D284001

01030821 1CD Cassava

- babyfood 0.050000 1.000 1.000 D28400

F ull comment: D284001

01031390 1CD Dasheen, corm 0.050000 1.000 1.000 D28400

Full comment: D284001

01031660 1CD Ginger 0.050000 1.000 1.000 D28400

Full comment: D284001

01031661 1CD Ginger

- babyfood 0.050000 1.000 1.000 D28400

Full comment: D284001

01031670 1CD Ginger, dried 0.050000 1.000 1.000 D28400

Full comment: D284001

01032960 1C Potato, chips 0.050000 1.000 1.000 D28400

Full comment: D284001

01032970 1C Potato, dry (granules/ flakes) 0.050000 6.500 1.000 D28400

Full comment: D284001

01032971 1C Potato, dry (granules/ flakes)

- b 0.050000 6.500 1. 000 D28400

Full comment: D284001

01032980 1C Potato, flour 0.050000 1.000 1.000 D28400

Full comment: D284001

01032981 1C Potato, flour

- babyfood 0.050000 1.000 1.000 D28400

Full com ment: D284001

01032990 1C Potato, tuber, w/peel 0.050000 1.000 1.000 D28400

Full comment: D284001

01032991 1C Potato, tuber, w/peel

- babyfood 0.050000 1.000 1.000 D28400

Full comment: D284001

01033000 1C Po tato, tuber, w/o peel 0.050000 1.000 1.000 D28400

Full comment: D284001

01033001 1C Potato, tuber, w/o peel

- babyfood 0.050000 1.000 1.000 D28400

Full comment: D284001

01033660 1CD Sweet potato 0.050000 1.000 1.000 D28400

Full comment: D284001

01033661 1CD Sweet potato

- babyfood 0.050000 1.000 1.000 D28400

Full comment: D284001

01033710 1CD Tanier, corm 0.050000 1.000 1.000 D2 8400

Full comment: D284001

01033870 1CD Turmeric 0.050000 1.000 1.000 D28400

Full comment: D284001

01034060 1CD Yam, true 0.050000 1.000 1.000 D28400

Full comment: D284001

01034070 1CD Yam bean 0.050000 1.000 1.000 D28400

Full comment: D284001

03001640 3 Garlic 0.200000 1.000 1.000

03001650 3 Garlic, dried 0.200000 1.000 1.000

03001651 3 Garlic, dried

- babyfood 0.200000 1.000 1.000

03001980 3 Leek 3.000000 1.000 1.000

03002370 3 Onion, dry bulb 0.200000 1.000 1.000 D28400

Full comment: D284001

03002371 3 Onion, dry bulb

- babyfood 0.200000 1.000 1.000 D28400

Full comment: D284001

03002380 3 Onion, dry bulb, dried 0.200000 9.000 1.000 D28400

### Pyrimethanil Dietary Exposure and Risk Assessment DP# 38998 6

_____________________________________________________________________________________________

Page 16 of 20 Full c omment: D284001

03002381 3 Onion, dry bulb, dried

- babyfood 0.200000 9.000 1.000 D28400

Full comment: D284001

03002390 3 Onion, green 3.000000 1.000 1.000 D28400

Full comment: D284001

03003380 3 Shallot 3.000000 1.000 1.000

08003750 8 Tomato 0.500000 1.000 1.000 D28400

Full comment: D284001

08003751 8 Tomato

- babyfood 0.500000 1.000 1.000 D28400

Full comment: D284001

08003760 8 Tomato, paste 0.500000 5.400 1.000 D28400

Full comment: D284001

08003761 8 Tomato, paste

- babyfood 0.500000 5.400 1.000 D28400

Full comment: D284001

08003770 8 Tomato, puree 0.500000 3.300 1.000 D28400

Full comment: D284001

08003771 8 Tomato, puree

- babyfood 0.500000 3.300 1.000 D28400

Full comment: D284001

08003780 8 Tomato, dried 0.500000 14.300 1.000 D28400

Full comment: D284001

08003781 8 Tomato, dried

- babyfood 0.500000 14.300 1.000 D28400

Full comment: D284001

08003790 8 Tomato, juice 0.500000 1.500 1.000 D28400

Full comment: D284001

10001060 10 Citrus citron 10.000000 1.000 1.000 D28400

Full comment: D284001

10001070 10 Citrus hybrids 10.000000 1.000 1.000 D28400

Full comment: D284001

10001080 10 Citrus, oil 150.000000 1.000 1.000 D28400

Full comment: D284001

10001800 10 Grapefruit 10.000000 1.000 1.000 D28400

Full comment: D284001

100018 10 10 Grapefruit, juice 10.000000 2.100 1.000 D28400

Full comment: D284001

10001970 10 Kumquat 10.000000 1.000 1.000 D28400

Full comment: D284001

10001990 10 Lemon 11.000000 1.000 1.000 8E7353

Full comment: 8E7353 Proposed Tolerance 2009

10002000 10 Lemon, juice 11.000000 2.000 1.000 8E7353

Full comment: 8E7353 Proposed Tolerance 2009

10002001 10 Lemon, juice

- babyfood 11.000000 2.000 1.000 8E7353

Full comment: 8E7353 Proposed Tolerance 2009

10002010 10 Lemon, peel 11.000000 1.000 1.000 8E7353

Full comment: 8E7353 Proposed Tolerance 2009

1000 2060 10 Lime 10.000000 1.000 1.000 D28400

Full comment: D284001

10002070 10 Lime, juice 10.000000 2.000 1.000 D28400

Full comment: D284001

10002071 10 Lime, juice

- babyfood 10.000000 2.000 1.000 D28400

Full comment: D284001

10002400 10 Orange 10.000000 1.000 1.000 D28400

Full comment: D284001

10002410 10 Orange, juice 10.000000 0.00 7 1.000 D28400

Full comment: D284001

10002411 10 Orange, juice

- babyfood 10.000000 0.007 1.000 D28400

Full comment: D284001

10002420 10 Orange, peel 10.000000 1.000 1.000 D28400

Ful l comment: D284001

10003070 10 Pummelo 10.000000 1.000 1.000 D28400

Full comment: D284001

10003690 10 Tangerine 10.000000 1.000 1.000 D28400

Full comment: D284001

10003700 10 Tangerine, juice 10.000000 2.300 1.000 D28400

Full comment: D284001

11000070 11 Apple, fruit with peel 14.000000 1.000 1.000 DP# 34

Full comment: DP# 347248

11000080 11 Apple, peeled fruit 14.000000 1.000 1.000 DP# 34

Full comment: DP# 347248

11000081 11 Apple, peeled fruit

- babyfood 14.000000 1.000 1.000 DP# 34

Full comment: DP# 347248

11000090 11 Apple, dried 14.000000 8.000 1.000 DP# 34

### Pyrimethanil Dietary Exposure and Risk Assessment DP# 38998 6

_____________________________________________________________________________________________

Page 17 of 20 Full comment: DP# 347248

11000091 11 Apple, dried

- babyfood 14.000000 8.000 1.000 DP# 34

Full comment: DP# 347248

11000100 11 Apple, juice 14.000000 0.350 1.000 DP# 34

Full comment: DP# 347248

11000101 11 Apple, juice

- babyfood 14.000000 0.350 1.000 DP# 34

Full comment: DP# 347248

11000110 11 Apple, sauce 14.000000 1.000 1.000 DP# 34

Full comment : DP# 347248

11000111 11 Apple, sauce

- babyfood 14.000000 1.000 1.000 DP# 34

Full comment: DP# 347248

11001290 11 Crabapple 14.000000 1.000 1.000 DP# 34

Full comment: DP# 347248

11002100 11 Loquat 14.000000 1.000 1.000 DP# 34

Full comment: DP# 347248

11002660 11 Pear 14.000000 1.000 1.000 DP# 34

Full comment: DP# 347248

11002661 11 Pear

- babyfood 14.000000 1.000 1.000 DP# 34

Full comment: DP# 347248

11002670 11 Pear, dried 14.000000 6.250 1.000 DP# 34

Full comment: DP# 347248

11002680 11 Pear, juice 14.0 00000 1.000 1.000 DP# 34

Full comment: DP# 347248

11002681 11 Pear, juice

- babyfood 14.000000 1.000 1.000 DP# 34

Full comment: DP# 347248

11003100 11 Quince 14.000000 1.000 1.000 DP# 34

Full comment: DP# 347248

12000120 12 Apricot 10.000000 1.000 1.000 8E7353

Full comment: 8E7353 Proposed Tolerance 2009

12000121 12 Apricot

- babyfood 10.000000 1.000 1.000 8E7 353

Full comment: 8E7353 Proposed Tolerance 2009

12000130 12 Apricot, dried 10.000000 6.000 1.000 8E7353

Full comment: 8E7353 Proposed Tolerance 2009

12000140 12 Apricot, juice 10.000000 1 .000 1.000 8E7353

Full comment: 8E7353 Proposed Tolerance 2009

12000141 12 Apricot, juice

- babyfood 10.000000 1.000 1.000 8E7353

Full comment: 8E7353 Proposed Tolerance 2009

12000900 12 Cherry 10.000000 1.000 1.000 8E7353

Full comment: 8E7353 Proposed Tolerance 2009

12000901 12 Cherry

- babyfood 10.000000 1.000 1.000 8E7353

Full comment: 8E7353 Proposed Tolerance 2009

12000910 12 Cherry, juice 10.000000 1.500 1.000 8E7353

Full comment: 8E7353 Proposed Tolerance 2009

12000911 12 Cherry, juice

- babyfood 10.000000 1.500 1.000 8E7353

Full comment: 8E7353 Proposed Tolerance 2009

12002300 12 Nectarine 10.000000 1.000 1.000 8E7353

Full comment: 8E7353 Proposed Tolerance 2009

12002600 12 Peach 10.000000 1.000 1.000 8E7353

Full comment: 8E7353 Proposed Tolerance 20 09

12002601 12 Peach

- babyfood 10.000000 1.000 1.000 8E7353

Full comment: 8E7353 Proposed Tolerance 2009

12002610 12 Peach, dried 10.000000 7.000 1.000 8E7353

Full comment: 8E7353 Proposed Tolerance 2009

12002611 12 Peach, dried

- babyfood 10.000000 7.000 1.000 8E7353

Full comment: 8E7353 Proposed Tolerance 2009

12002620 12 Peach, juice 10.000000 1.000 1.000 8E7353

Full comment: 8E7353 Proposed Tolerance 2009

12002621 12 Peach, juice

- babyfood 10.000000 1.000 1.000 8E7353

Full comment: 8E7353 Proposed Tolerance 2009

12002850 12 Plum 1 0.000000 1.000 1.000 8E7353

Full comment: 8E7353 Proposed Tolerance 2009

12002851 12 Plum

- babyfood 10.000000 1.000 1.000 8E7353

Full comment: 8E7353 Proposed Tolerance 2009

12002860 12 Plum, prune, fresh 10.000000 1.000 1.000 8E7353

Full comment: 8E7353 Proposed Tolerance 2009

12002861 12 Plum, prune, fresh

- babyfood 10.000000 1.000 1.000 8E7353

Full comment: 8E7353 Proposed Tolerance 2009

12002870 12 Plu m, prune, dried 10.000000 5.000 1.000 8E7353

Full comment: 8E7353 Proposed Tolerance 2009

12002871 12 Plum, prune, dried

- babyfood 10.000000 5.000 1.000 8E7353

Full comment: 8E7353 Proposed Tolerance 2009

### Pyrimethanil Dietary Exposure and Risk Assessment DP# 38998 6

_____________________________________________________________________________________________

Page 18 of 20 1 2002880 12 Plum, prune, juice 10.000000 1.400 1.000 8E7353

Full comment: 8E7353 Proposed Tolerance 2009

12002881 12 Plum, prune, juice

- babyfood 10.000000 1.400 1.000 8E7353

Full comment: 8E7353 Proposed Tolerance 2009

13010550 13A Blackberry 12.000000 1.000 1.000

13010560 13A Blackberry, juice 12.000000 1.000 1.000

13010561 13A Blackberry, juice

- babyfood 12.000000 1.000 1.000

13010580 13A Boysenberry 12.000000 1.000 1.000

13011420 13A Dewberry 12.000000 1.000 1.000

13012080 13A Loganberry 12.000000 1.000 1.000

13013200 13A Raspberry 12.000000 1.000 1.000

13013201 13A Raspberry

- babyfood 12.000000 1.000 1.000

13013210 13A Raspberry, juice 12.000000 1.000 1.000

13013211 13A Raspberry, juice

- babyfood 12.000000 1. 000 1.000

13020570 13B Blueberry 6.000000 1.000 1.000

13020571 13B Blueberry

- babyfood 6.000000 1.000 1.000

13021360 13B Currant 6.000000 1.000 1.000

13021370 13B Curr ant, dried 6.000000 1.000 1.000

13021490 13B Elderberry 6.000000 1.000 1.000

13021740 13B Gooseberry 6.000000 1.000 1.000

13021910 13B Huckleberry 6.000000 1.000 1.000

14000030 14 Almond 0.200000 1.000 1.000 D28400

Full comment: D284001

14000031 14 Almond

- babyfood 0.200000 1.000 1.000 D28400

Full comment: D284001

1400 0040 14 Almond, oil 0.200000 1.000 1.000 D28400

Full comment: D284001

14000041 14 Almond, oil

- babyfood 0.200000 1.000 1.000 D28400

Full comment: D284001

14002820 14 Pistachio 0.200000 1.000 1.000

21000440 M Beef, meat 0.010000 1.000 1.000 D28400

Full comment: D284001

21000441 M Beef, meat

- babyfood 0.010000 1.000 1.000 D28400

Full comment: D284001

21000450 M Beef, meat, dried 0.010000 1.920 1.000 D28400

Full comment: D284001

21000460 M Beef, meat byproducts 0.010000 1.000 1.000 D28400

Full comment: D28400 1

21000461 M Beef, meat byproducts

- babyfood 0.010000 1.000 1.000 D28400

Full comment: D284001

21000470 M Beef, fat 0.010000 1.000 1.000 D28400

Full comment: D284001

21000471 M Beef,fat

- babyf ood 0.010000 1.000 1.000 D28400

Full comment: D284001

21000480 M Beef, kidney 2.500000 1.000 1.000 DP# 34

Full comment: DP# 347248

21000490 M Beef, liver 0.0100 00 1.000 1.000 D28400

Full comment: D284001

21000491 M Beef, liver

- babyfood 0.010000 1.000 1.000 D28400

Full comment: D284001

23001690 M Goat, meat 0.010000 1.000 1.000 D28400

Full comment: D284001

23001700 M Goat, meat byproducts 0.010000 1.000 1.000 D28400

Full comment: D284001

23001710 M Goat, fat 0.010000 1.000 1.000 D28400

Full comment: D284001

23 001720 M Goat, kidney 2.500000 1.000 1.000 DP# 34

Full comment: DP# 347248

23001730 M Goat, liver 0.010000 1.000 1.000 D28400

Full comment: D284001

24001890 M Horse, meat 0.010000 1.000 1.000 D28400

Full comment: D284001

26003390 M Sheep, meat 0.010000 1.000 1.000 D28400

Full comment: D284001

26003391 M Sheep, meat

- babyfood 0.010000 1.000 1.000 D28400

Full comment: D284001

26003400 M Sheep, meat byproducts 0.010000 1.000 1.000 D28400

Full comment: D284001

26003410 M Sheep, fat 0.010000 1.000 1.000 D28400

Full comment: D284001

26003411 M Sheep, fat

- babyfood 0.010000 1.000 1.000 D28400

### Pyrimethanil Dietary Exposure and Risk Assessment DP# 38998 6

_____________________________________________________________________________________________

Page 19 of 20 Full comment: D284001

26003420 M Sheep, kidney 2.500000 1.000 1.000 DP# 34

Full comment: DP# 347248

260 03430 M Sheep, liver 0.010000 1.000 1.000 D28400

Full comment: D284001

27002220 D Milk, fat 0.050000 1.000 1.000 DP# 34

Full comment: DP# 347248

27002221 D Milk, fat

- baby food/infant for 0.050000 1.000 1.000 DP# 34

Full comment: DP# 347248

27012230 D Milk, nonfat solids 0.050000 1.000 1.000 DP# 34

Full comment: DP# 347248

27012231 D Milk, nonfat solids

- baby food/in 0.050 000 1.000 1.000 DP# 34

Full comment: DP# 347248

27022240 D Milk, water 0.050000 1.000 1.000 DP# 34

Full comment: DP# 347248

27022241 D Milk, water

- babyfood/infant form 0.050000 1.000 1.000 DP# 34

Full comment: DP# 347248

27032251 D Milk, sugar (lactose)

- baby food/ 0.050000 1.000 1.000 DP# 34

Full comment: DP# 347248

86010000 O Water, direct, all sources 0.029400 1.000 1.000 USEPA

Full comment: USEPA EFED memo 9

- 26

- 2011

86020000 O Water, indirect, all sources 0.029400 1.000 1.000 USEPA

Full comment: USEPA EFED memo 9

- 26

- 2011

95000230 O Banana 0.100000 1.000 1.000

95000231 O Banana

- babyfood 0.100000 1.000 1.000

95000240 O Banana, dried 0.100000 3.900 1.000

95000241 O Banana, dried

- babyfood 0.100000 3.900 1.000

95001300 O Cranberry 3.000000 1.000 1.000

95001301 O Cranberry

- babyfood 3.000000 1.000 1.000

95001310 O Cranberry, dried 3.000000 1.000 1.000

95001320 O Cranberry, juice 3.000000 1. 000 1.000

95001321 O Cranberry, juice

- babyfood 3.000000 1.000 1.000

95001750 O Grape 5.000000 1.000 1.000 D28400

Full comment: D284001

95001760 O Grape, juice 5.0000 00 1.200 1.000 D28400

Full comment: D284001

95001761 O Grape, juice

- babyfood 5.000000 1.200 1.000 D28400

Full comment: D284001

95001770 O Grape, leaves 5.000000 1.000 1.000 D28400

Full comment: D284001

95001780 O Grape, raisin 8.000000 1.000 1.000 D28400

Full comment: D284001

95001790 O Grape, wine and sherry 5.000000 1.000 1.000 D28400

Full comment: D284001

95002830 O Plantain 0.100000 1.000 1.000

95002840 O Plantain, dried 0.100000 3.900 1.000

95003590 O Strawberry 3.000000 1.000 1.000 D28400

Full comment: D 284001

95003591 O Strawberry

- babyfood 3.000000 1.000 1.000 D28400

Full comment: D284001

95003600 O Strawberry, juice 3.000000 1.000 1.000 D28400

Full comment: D284001

95003601 O Strawberr y, juice

- babyfood 3.000000 1.000 1.000 D28400

Full comment: D284001

### Pyrimethanil Dietary Exposure and Risk Assessment DP# 38998 6

_____________________________________________________________________________________________

Page 20 of 20 

## Attachment 4: DEEM

- FCID Chronic Exposure Estimates

U.S. Environmental Protection Agency Ver. 2.00

DEEM

- FCID Chronic analysis for PYRIMETHANIL (1994

- 98 data)

Residue file name: C: \ Documents and Settings \ gkramer \ My

Documents \ Gk \ #Pyrimethanil \ 288201c.R98

Adjustment factor #2 used.

Analysis Date 05

- 02

- 2012/13:40:00 Residue file dated: 04

- 26

- 2012/15:27:50/8

Reference dose (RfD, Chronic) = .17 mg/kg bw/day

COMMENT 1: FQPA SF 1X for all endpoints; cPAD for all populations is 0.17 mg/kg/day

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

Total exposure by population subgroup

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

Total Exposure

----- ------------------------------ Population mg/kg Percent of

Subgroup body wt/day Rfd

-------------------------------------- ------------- --------------- U.S. Population (total) 0.023155 13.6%

U.S. Population (spring season) 0.023684 13.9%

U.S. Population (summer season) 0.021689 12.8%

U.S. Population ( autumn season) 0.023173 13.6%

U.S. Population (winter season) 0.024156 14.2%

Northeast region 0.025876 15.2%

Midwest region 0.0232 07 13.7%

Southern region 0.019507 11.5%

Western region 0.026447 15.6%

Hispanics 0.026178 15.4%

Non

- hispa nic whites 0.022902 13.5%

Non

- hispanic blacks 0.020961 12.3%

Non

- hisp/non

- white/non

- black 0.026304 15.5%

All infants (< 1 year) 0.092221 54.2%

Nursing infants 0.054451 32.0%

Non

- nursing infants 0.106559 62.7%

Children 1

- 6 yrs 0.081784 48.1%

Ch ildren 7

- 12 yrs 0.031322 18.4%

Females 13

- 19 (not preg or nursing) 0.014399 8.5%

Females 20+ (not preg or nursing) 0.015086 8.9%

Females 13

- 50 yrs 0.015832 9.3%

Females 13+ (preg/not nursing) 0.019759 11.6%

Females 13+ (nursing) 0.020096 11.8%

Males 13

- 19 yrs 0.013026 7.7%

Males 20+ yrs 0.013059 7.7%

Seniors 55+ 0.017637 10.4%

Children 1

- 2 yrs 0.108087 63.6%

Children 3

- 5 yrs 0.074796 44.0%

Children 6

- 12 yrs 0.034198 20.1%

Youth 13

- 19 yrs 0.013698 8.1%

Adults 20

- 49 yrs 0.012575 7.4%

Adults 50+ yrs 0.017041 10.0%

Females 13

- 49 yrs 0.013724 8.1%

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