Thiram Dietary Exposure and Risk Assessment DP # 418045



### UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, 

### D.C. 20460

Office of Chemical Safety and Pollution Prevention



### MEMORANDUM

DATE: 11 -February-2014

SUBJECT: Thiram: Revised Acute and Chronic Dietary (Food and Drinkin g Water) Exposu re and Risk Assessment to Support a Petition For an Increased Tolerance

on Strawberry and the Conversion of the Time-Limited Banana To lerance to Permanent.

PC Code: 07980 I Decision No.: 471074 Petition No.: 2F8 106 Risk Assessment Type: Dietary TXRNo.: NA MRIDNo.: NA DP No.: D 418045 Registration No

. : NA Regulatory Action: NA Case No.: NA CAS No.: 137-26-8 40 CFR : §180.132



### FROM: Thurston G. Morton, Chemist 

## /?_

· /}

# ~r- Risk Assessment Branch IV

## ~/ - / Health Effects Division (7509P)



### THROUGH: Doug Dotson, PhD

., Senio Kristin Rury

, Biologist Dietary Exposure Science Advis Health Effects Division (7509P)

And



### Susan Humm e l

, Senior Scie nti st Elissa Reaves

, Ph.D., Branch C hie f Risk Assessment Branch IV Health Effects Division (7509P)



### TO: Shaunta Hill Fungicide Branch Registration Division (7505P)

Revised thiram ac u te and chronic dietary (food and drinking water) exposure assessments were conducted using the Dietary Exposure Evaluation Model software with the Food Co mmodity Intak e Database DEEM

- FCIDTM, Version 3.16. This software u ses 2003-2008 food consumption data from the U

. S. Department of Agriculture's (USDA ' s) National Health and Nutr ition Examination Survey, What We Eat in America

, (NHANESIWWEIA). The analyses

P age I of 14Thiram Dietary Exposure and Risk Assessment DP# 418045



### were performed to evaluate the proposed tolerance increase on strawberry from 7 ppm to 20 ppm and to convert the time-l i mited tolerance on bananas to a permanent tolerance.

This memorandum was reviewed by two peer reviewers of the DESAC, per DESAC Standard Operating Procedure (SOP) 2012.1.

Acute Dietary (Food and Drinking Water) Exposure Results and Cha racteri za tion

A partially refined probabilistic acute dietary-exposur e assessment was perform ed using I 

### 00 percent crop treated (%CT), tolerance, the highest residue found during field-trials

, distributions of field trial residues, and empirical processing factors. Dietary risk es timate s were determin ed considering exposures from food and drinking water u s ing estimated drinking water concentrations (EDWCs) for surface water sources provided by the Env irorunental Fate and Effects Division (EFED).

T h e acute dietary risk estimates for food and drinking water combined are b e lo w HED' s level of

concern (i.e., < 1 00% of the aPAD of0.6494 mg/kg bw / day) for th e gene ral U.S. popu l ation and all population subg roups ( including females 13-49 years old; aPAD of0.014 mg/kg bw / day). Using DEEM-FCID, acute dietary exposure at the 95 111 

### exposure percenti le is esti mated at 0.012053 m g/kg bw/day for the genera l U.S. population (1.9% of the aPAD) and 0.008637 mg/kg bw / day (62% of the aPAD) for fema l es 13-49 years old, the population subgro up with the highest percent aP AD dietary exposure to thiram.

Chro nic Dietary (Food and Drinking Water) Exposure Results and C haracteri zation

A partially refmed c hroni c dietary-exposure assessment was performed usin g tolerances, average field trial re si due s, banana tolerance, and empirical processing factors. Dietary risk estimates

were determined considering exposures from food and drinking water using EDWCs for surface

water sources provided by EFED. The resulting chronic dietary risk estimates for food and water combined are below HED ' s level of concern (i.e.

, < 100 % ofthe chro nic population adjusted do se; cPAD of0.015 m g!kg bw / day) for the general U.S. population and all population

s ubgroups. Using DEEM-FCID, dietary exposure i s estimated at 0.002257 mg/kg bw/day for the general U.S. popu l ation (15% ofthe cPAD) and 0.012007 mg/kg bw/day (80% of the cPAD) for children 1-2 years o ld

, the population subg roup with the highest estimated chronic dietary
expos ure to thiram.



### I. INTRODUCTION

Dietary risk assessment incorporates both exposure and toxicity of a given pesticide. For acute and chronic assessments
, the risk is expressed as a percentage of a maximum acceptable dose (i.e., the dose that HED has concluded will result in no unreasonable adverse health effects). This dose is referred to as the 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 , HED i s concerned when estimated dietary risk exceeds 100% of the PAD. References that discuss the acute and chronic risk assessments in

more detail are availab le on the EPA/pesticides web site: "Available Information on Assessing Exposure from Pesticides, A Use r 's Guide," 21-JUN-2000, web link :

Page 2 of 14Thi ram Dietary Exposure and Risk Assessment DP # 418045

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Page 3 of 14 

### 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 thiram was conducted by T

. Morton ( D 4 12466

, 12 / 10 / 1 3 ).

II. RESIDUE INFORMATION

Residue Data used fo r Acute and Chronic Assessments

Established Tolerances: Tolerances for residues in/on food and feed commodities are currently expressed in terms of residues of thiram (tetramethyl thiuram disulfide) [40 CFR §180.132] are established at 7.0 ppm for apples, strawberries, and peaches. A time

- limited import tolerance is also established for thiram on bananas at 0.80 ppm. Thiram is also the residue of concern in plants for dietary risk assessment purposes.

Acute Anticipated Residues

For the probabilistic acute dietary

- exposure analysis, the entire distribution of field

- trial data was

u sed to generate residue

- distribution files (RDFs) for commodities that are not considered blended or partially blended (see Table 2). For commodities that were considered blended ( i.e. dried apple, dried banana, and dried peach), point

- estimate s consistin g of the average field

- trial residue were used

. Empirical processing factors were used. In addition 100% crop treated was used.

Chronic Anticipated Residues

Tolerances level residues for banana and average field trial residues for apples, peaches and

s trawberries along with 100% crop treated were used for the chronic dietary exposure analysis for all crops. Empirical processing factors were also used.

The USDA Pesticide Data Program (PDP) monitored pesticide residues in catfish in 2008. PDP did not analyze catfish samples for thiram residues. As a result, residues in fish were not included in the assessment.

Processing Factors

Processing factors were obtained from strawberry washing and apple processing studies submitted to the Agency by the regi strant (F. Fort, D283996, 0 4/20/03 ). The strawberry washing factor was used for strawberries only. The apple washing factor was used for peaches and apples. The apple drying factor was used for apples, peaches, and bananas. The apple sauce factor was u sed for apple sauce, peach babyfood, and strawberry babyfood. Finally, the apple juice factor was used for apple, peaches, and strawberries. The table below shows the results of these studies and the processing factors that were used to refine the acute and chronic
assessments.Thi ram Dietary Exposure and Risk Assessment DP # 418045

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Page 4 of 14 Table 1. Processing Factors. Type Factor Consumer practice (strawberry) 0.42 Washing (apple) 0.79 Drying (apple) 2.4 used for all dried commodities Sauce (apple) 0.18 used also for baby food commodities Juice (apple) 0.12



### Percent Crop Treated Information

Percent crop treated was set at 100 % for the acute and chronic dietary exposure analyses.

Table 2. Summary of Anticipated Residues for Thiram.

Commodity Classification 1 Data Used 2 Processing

Factor Percent Crop Treated 3 Residue Distribution for Acute Anticipated Residue Chronic

Anticipated Residue, ppm Weighted Avg

. Estimated

Max
Avocado NB/PB FT 1 100 100 0.05 pulp residue 0.05

Apple, fruit with peel Apple, peeled fruit NB/PB FT 0.79 100 100 RDF # 1

A pples 'Apples '100% Ct TOTALZ=0 TOTALNZ=20 0.95 , 2.09 , 0.91 , 1.41 , 4.22 , 0.86 , 8.65 , 5.18 , 6.75 , 4.56 , 2.93 , 3.98 , 4.24 , 4.69 , 5.60 , 5.97 , 6.53 , 1.62 , 1.72 , 1.72 3.7

Apple, peeled fruit

babyfood PB FT 0.79 100 100 RDF #1 3.7

Apple, drie d Apple, dried

- babyfood B FT 2.4 100 100 7.0 3.7

Apple, juice Apple, juice

- babyfood PB FT 0.12 100 100 RDF # 1 3.7

Apple, sauce Apple, sauce

- babyfood PB FT 0.18 100 100 RDF # 1 3.7

Peach NB/PB FT 0.79 100 100 RDF #2

'Peaches
100 % CT
TOTALZ= 100
TOTAL NZ=21
3.29

, 6.42

, 3.04

, 3.47
4.54

, 5.93

, 2.19

, 2.61
2.98

, 1.47

, 1.90

, 3.17
2.49

, 1.90

, 3.10

, 3.37
5.38

, 3.95

, 2.24

, 1.73
1.91 3.2

Peach, babyfood PB FT 0.18 100 100 RDF #2 3.2

Peach, dried Peach, dried

- babyfood B FT 2.4 100 100 6.42 3.2Thi ram Dietary Exposure and Risk Assessment DP # 418045

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Page 5 of 14 Table 2. Summary of Anticipated Residues for Thiram.

Commodity Classification 1 Data Used 2 Processing

Factor Percent Crop Treated 3 Residue Distribution for Acute Anticipated Residue Chronic

Anticipated Residue, ppm Weighted Avg

. Estimated

Max Peach, juice P each, juice

- babyfood PB FT 0.12 100 100 RDF #2 3.2

Strawberry PB FT 0.42 100 100 RDF #3 New Data: 'Strawberries

' 10 0% CT
TOTALZ= 0
TOTALNZ=10
3.45

, 3.15

, 4.30

, 0.05
4

, 11.4

, 5.40

, 5.3

, 4.2
7.65 4.9

Strawberry

- babyfood PB FT 0.18 100 100 RDF #3 4.9 Strawberry

- juice Strawberry, juice

- babyfood PB FT 0.12 100 100 RDF #3 4.9

Banana, peeled fruit Banana, peeled fruit

babyfood NB/PB FT 1.0 100 100 Bananas ( pulp ) 0.112

, 0.125

, 0.127

, 0.135

, 0.236

, 0.276

, 0.225

, 0.222

, 0.211

, 0.186

, 0.135

, 0.178 0.0745

, 0.0718

, 0.0608 0.0618

, 0.0334

, 0.0435 0.0452

, 0.0442

, 0.0705 0.0662

, 0.138

, 0.118 0.0951

, 0.101

, 0.0640 0.0780 0 .80

Banana , dried Banana, dried

- babyfood B FT 2.4 100 100 0.276 0. 80

1 NB = Non

- blended; PB = partially blended; B = ble nded. 2 FT = field

- trial data.



### I II. Drinking Water Data

The current action will not affect the EDWCs, therefore, the previous drinking water assessment (J. Carleton and F. Jenkins

, 12/11/03 ) is still applicable . Because monitoring data are unavailable

, estimates of thiram concentrations were made only with mathematical models. EDWC values were generated by the PRZM (Pesticide Root Zone Model)

- EXAMS (Exposure Analysis Modeling System) for the turf application scenario, since this scenario yielded the h ighest EDWC values. Ground water sources were not included, as the EDWCs for this water source are minimal in comparison to those for surface water. Water residues ( surface water EDWC of 0.047 8 ppm for acute and 0.0025 ppm for chronic ) were incorporated in DEEM

- FCID into the food categories “water, direct, all sources” and “water, indirect, all sources” for the dietary assessments.

Table 3

. EDWCs for Use in the Human

- Health Risk Assessment.

Crop Annual

App Rate (lbs ai/acre/yr) SCIGROW

concentration (ppb) PRZM/EXAMS*

Acute EDWC (ppb) PRZM/EXAMS*

non - cancer chronic EDWC (ppb)
Turf farm 146.6 0.84 47.8 2.5
* Index Reservoir environmentThi ram Dietary Exposure and Risk Assessment DP # 418045

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Page 6 of 14 

### IV. DEEM

- FCIDTM PROGRAM AND CONSUMPTION INFORMATION

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

- FCID, Version 3.16

. This software uses 2003

- 2008 food consumption data from the U.S. Department of Agriculture’s (USDA’ s) National Health and Nutrition Examination Survey, What We Eat in America, (NHANES/WWEIA). The 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 li nked to EPA

- defined food commodities (e.g. apples, peeled fruit

- cooked; fresh or N/S; baked; or wheat flour

- cooked; fresh or N/S, baked) using publicly available recipe translation files developed jointly by USDA/ARS and EPA. For chronic exposure asse ssment, 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 2003

- 2008 WWEIA consumption data, which took in to 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

- 99 years old.

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

form (e.g., orange or orange juice) on the food commodity residue list is multiplied by the
averag e 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 lis t 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 consumpti on 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 “matc hed” in multiple random pairings with residue values and then summed in a probabilistic assessment. The resulting distribution of exposures is expressed as a percentage of the aPAD on both a user (i.e., only those who reported eating relevant commodities/ food forms) and a per

- capita (i.e., those who reported eating the relevant commodities as well as those who did not) basis. In accordance with HED policy, per capita exposure and risk are reported for all tiers of analysis. However, for tiers 1 and 2, an y significant differences in user vs. per capita exposure and risk are specifically identified and noted in the risk assessment.

V. TOXICOLOGICAL INFORMATION

A summary of the toxicological endpoints and doses chosen for the relevant exposure scenarios fo r human risk assessment are found in Table 4.Thi ram Dietary Exposure and Risk Assessment DP # 418045

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Page 7 of 14 Table 4 . Summary of Toxicological Doses and Endpoints for Thiram for Use in Dietary Risk Assessments.

Exposure/ Scenario Point of

Departure Uncertainty/FQPA

Safety Factors RfD, PAD,

LOC for Risk Assess ment Study and Toxicological Effects Acute Dietary ( General Population ) BMDL 10 =

64.94 mg/kg /day UF A = 10x

UF H = 10x FQPA SF = 1x Acute RfD = 0. 64 94 mg/kg/day

aPAD = 0. 64 94 mg/kg/day Acute Neurotoxicity Study

- Rat

LOAEL = 150 mg/kg/day based on FOB effects (lethargy, lower temperature, reduced startle response, no tail pinch response), reduced motor activity, and reduced brain weights. Acute Dietary (Females 13

- 49 years old ) NOAEL = 1.4

mg/kg /day UF A = 10x

UF H = 10x FQPA SF = 1x Acut e RfD = 0.014 mg/kg/day

aPAD =0.014 mg/kg/day Dev. Neurotoxicity Study

- Rat

LOAEL = 3.7 mg/kg/day based on increases in motor activity seen in female offspring on PND 17

Chronic Dietary (All populations) NOAEL = 1.5

mg/kg /day UF A = 10x

UF H = 10x FQPA SF = 1x Chronic RfD = 0.015 mg/kg/day

cPAD =0.015 mg/kg/day Combined Chronic

Toxicity/Carcinogenicity Study

- Rat & Chronic Oral Toxicity Study

- Dog LOAEL = 7.3 mg/kg/day based on changes in hematology, clinical chemistry, incidences of b ile duct hyperplasia, and reduction in mean body weight gain seen at 7.9 mg/kg/day in conjunction with elevated cholesterol levels and increased liver weights reported in the chronic oral toxicity study in dog s at 2.6 mg/kg/day Cancer (oral, dermal, inhal ation) “Not Likely to be Carcinogenic to Humans”

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 enviro nmentally 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

amon g members of the human population (interspecies). FQPA SF = FQPA Safety Factor. PAD = population

adjusted dose (a = acute, c = chronic). RfD = reference dose.



### VI. RESULTS/DISCUSSION AND CONCLUSIONS

As stated above, for acute and chronic assessments , HED is generally concerned when dietary risk exceeds 100% of the PAD. The DEEM

- FCID analyses estimate the dietary exposure of the general U.S. population and various population subgroups. The results reported in Tables 5 and 6 are for the general U.S. 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

- 99 years old

.Thi ram Dietary Exposure and Risk Assessment DP # 418045

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Page 8 of 14 

### Results of Acute Dietary

- Exposure Analysis

A partially refined probabilistic acute dietary

- exposu re assessment was performed using 100 %CT

, highest residue of field

- trial residue values, distribution of field trial residues, and empirical processing factors . Dietary risk estimates were determined considering exposures from food plus drinking water us ing EDWCs for surface water sources provided by EFED.

The acute dietary risk estimates for food and drinking water combined are below HED’s level of concern ( i.e. , <100% of the aPAD of 0.6494 mg/kg bw/day) for the general U.S. population and all populat ion subgroups (including females 13

- 49 years old ; aPAD of 0.014 mg/kg bw/day). Using DEEM

- FCID, acute dietary exposure at the 95 th 

### exposure percentile is estimated at 0.0 1205 3 mg/kg bw /day for the general U.S. population ( 1.9 % of the aPAD) and 0.0 0863 7
mg /kg bw /day ( 62 % of the aPAD) for females 13

- 49 years old , the population subgroup with the highest % aPAD dietary exposure t o thiram. The estimated exposures/risks for food and drinking water are summarized in Table 5.

Table 5. Results of Acute Dietary Exposure and Risk Analysis for Thiram (Food + Water )

.

Population Subgroup aPAD

(mg/kg/day) 95 th Percentile

Exposure (mg/kg/day) % aPAD
General U.S. Population 0.6494 0. 01205 3 1.9
All Infants (<1 year old) 0.6494 0. 02718 9 4.2
Children 1

- 2 years old 0 .6494 0.0 435 72 6.7
Children 3

- 5 years old 0.6494 0.0 3229 5 5.0
Children 6

- 12 years old 0.6494 0.0 188 13 2.9
Youth 13

- 19 years old 0.6494 0.0 09850 1.5
Adults 20

- 49 years old 0.6494 0.00 795 9 1.2
Adults 50

- 99 years old 0.6494 0.00 87 60 1.4
Females 13

- 49 ye ars old 0.014 0.0 0863 7 6 2 * The values for the highest risk population for each percentile are bolded.



### Results of Chronic Dietary

- Exposure Analysis

The partially refined chronic dietary risk estimates for food and water combined are below HED’s level o f concern ( i.e. , <100% of the cPAD of 0.015 mg/kg bw/day) for the genera l U.S. population and all population subgroups. Using the DEEM

- FCID software, dietary exposure is estimated at 0.00 22 57 mg/kg bw /day for the general U.S. population ( 15 % of the cPAD) and 0.0 119 43 mg/kg bw /day ( 80 % of the cPAD) for children 1

- 2 years old , the population subgroup with the highest estimated chronic dietary exposure to thiram. The estimated exposures/risks for food and drinking water are summarized in Table 6.Thi ram Dietary Exposure and Risk Assessment DP # 418045

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Page 9 of 14 Table 6

. Summary of Chronic Dietary Exposure and Risk for Thiram (Food + Water )

. Age Group cPAD (mg/kg/day) Exposure (mg/kg/day) % cPAD General U.S. Population 0.015 0.00 22 57 15 All Infants (<1 year old) 0.015 0.00 66 69 4 5

Children 1

- 2 years old 0.015 0.0 1 2007 80
Children 3

- 5 years old 0.015 0.00 75 75 5 1
Children 6

- 12 years old 0.015 0.00 36 33 24

Youth 13

- 19 years old 0.015 0.00 15 23 10
Adults 20

- 49 years old 0.015 0.00 12 25 8. 2
Adults 50

- 99 years old 0.015 0.00 16 53 11
Females 13

- 49 years old 0.015 0.00 1 3 35 8. 9 * The values for the highest exposed population is bolded.



### VII. DISCUSSION OF UNCERTAINTIES

Residues in all foods were based on the results of field trials

. Field

- trial residues should exceed the residue levels found on food commodities at the time of consumption. When field trials are performed, the maximum allowable application rate is used and crops are harvested at the minimum pre

- harvest interval ( PHI ) . Samples are stored frozen until analysis to ensure minimal degradation of residues. I n actual practice, however, growers will not usually use the maximum application rates for economic reasons. In addition, most crops are not harvested and immediately stored frozen. For these reasons, HED is confident that this analysis does not underest imate risk to the general U.S. population or any population subgroup.

VIII. LIST OF ATTACHMENTS

Attachment 1

- Residue Inputs for Acute Dietary Assessment of Thiram Attachment 2

- Results of Refined Acute Dietary Analysis for Thiram Attachment 3

- Resid ue Inputs for Chronic Dietary Assessment of Thiram Attachment 4

- Results of Partially Refined Chronic Dietary Analysis for Thiram

cc: T. Morton (RAB 4 ) T. Morton : S10 838 : PY

- S :(703)305

- 6691 :7509 P :RAB 4Thi ram Dietary Exposure and Risk Assessment DP # 418045

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Page 10 of 14 

### Attachment 1

- Residue Inputs for Acute Dietary Asse ssment of Thiram

Filename: C: \ Documents and Settings \ tmorton \ My Documents \ MyFiles \ DEEM Files \ 079801 Thiram \ Strawberry \ 079801 Acute Tolerance HR for Banana Strawberry and Peach RDF for FDA Apple Plus Strawberry Apple Peach Washing Factor %CT Apple FT Apple Washing All 100CT.R08 Chemical: Thiram RfD(Chronic): .015 mg/kg bw/day NOEL(Chronic): 0 mg/kg bw/day RfD(Acute): .6494 mg/kg bw/day NOEL(Acute): 0 mg/kg bw/day Date created/last modified: 01

- 30

- 2014/14:49:36 Program ver. 3.16, 03

- 08

- d

---------- ------------------------------------------------------------------------- RDL indices and parameters for Monte Carlo Analysis: Index Dist Parameter #1 Param #2 Param #3 Comment # Code

----- ---- ------------ -------- -------- ------- 1 6 apple 100 CT.rdf 2 6 peach FT 100CT.rdf 3 6 straw New FT 100CT.rdf

EPA Crop Commodity Name Def Res Adj.Factors RDLComment Code Grp (ppm) #1 #2 P ntr

---------- ---- ------------------------------- ---------- ------ ------ --- ------- 1100007000 11 Apple, fruit with peel 7.000000 0.790 1.000 1 1100008000 11 Apple, peeled fruit 7.000000 0.790 1.000 1 11 00008001 11 Apple, peeled fruit

- babyfood 7.000000 0.790 1.000 1 1100009000 11 Apple, dried 7.000000 2.400 1.000 1100009001 11 Apple, dried

- babyfood 7.000000 2.400 1.000 1100010000 11 Apple, juice 7.000000 0.120 1.000 1 1100010001 11 Apple, juice

- babyfood 7.000000 0.120 1.000 1 1100011000 11 Apple, sauce 7.000000 0.180 1.000 1 1100011001 11 Apple, sauce

- babyfood 7.000000 0.180 1.000 1 1202260000 12B Peach 6.420000 0.790 1.000 2 1202260001 12B Peach

- babyfood 6.420000 0.180 1.000 2 1202261000 12B Peach, dried 6.420000 2.400 1.000 1202261001 12B Peach, dried

- babyfood 6.420000 2.400 1.000 1202262000 12B Peach, juice 6.420000 0.120 1.000 2 1202262001 12B Peach, juice

- babyfood 6.4 20000 0.120 1.000 2 1307359000 13G Strawberry 11.400000 0.420 1.000 3 1307359001 13G Strawberry

- babyfood 11.400000 0.180 1.000 3 1307360000 13G Strawberry, juice 11.400000 0.120 1.000 3 1307360001 13G Strawberry, juice

- babyfood 11.400000 0.120 1.000 3 8601000000 86A Water, direct, all sources 0.047800 1.000 1.000 8602000000 86B Water, indirect, all sources 0.047800 1.000 1.000 9500020000 O Avocado 0.050000 1.000 1.000 Pulp R Full comment: Pulp Residues 9500023000 O Banana 0.276000 1.000 1.000 9500023001 O Banana

- babyfood 0.27 6000 1.000 1.000 9500024000 O Banana, dried 0.276000 2.400 1.000 9500024001 O Banana, dried

- babyfood 0.276000 2.400 1.000 9500283000 O Plantain 0.276000 1.000 1.000 9500284000 O Plantain, dried 0.276000 2.400 1.000Thi ram Dietary Exposure and Risk Assessment DP # 418045

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Page 11 of 14 

### Residue Distribution Files (rdfs)

RDF #1 'Apples '100% Ct TOTALZ=0 TOTALNZ=20 0.95 2.09 0.91 1.41 4.22 0.86 8.65 5.18 6.75 4.56 2.93 3.98 4.24 4.69 5.60 5.97 6.53 1.62 1.72 1.72

RDF #2
'Peaches '100% CT TOTALZ=0 TOTALNZ=21

3.29 6.42 3.04 3.47 4.54 5.93 2.19 2.61 2.98 1.47 1.90 3.17 2.49 1.90 3.10 3.37 5.38 3.95 2.24 1.73 1.91

RDF #3 'Strawberries '100% CT TOTALZ=0 TOTALNZ=10

3.45 3.15 4.30 0.05
4 11.4 5.40 5.3 4.2 7.65Thi ram Dietary Exposure and Risk Assessment DP # 418045

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Page 12 of 14 

### Attachment 2

- Results of Acute Dietary Analysis for Thiram

U.S. EPA Ver. 3.16, 03

- 08

- d
DEEM

- FCID ACUTE Analysis for THIRAM NHANES 2003

- 2008 2

- Day Residue fil e: 079801 Acute Tolerance HR for Banana Strawberry and Peach RDF for FDA Apple Plus Strawberry Apple Peach Washing Factor %CT Apple FT Apple Washing All 100CT.R08 Adjustment factor #2 used. Analysis Date: 02

- 12

- 2014/11:45:48 Residue file dated: 02

- 12

- 2014/11:35:14 Acute Pop Adjusted Dose (aPAD) varies with population; see individual reports RAC/FF intake summed over 24 hours MC iterations = 1000; MC list in residue file; MC seed = 10281; RNG = MS VB
Run Comment: ""

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

Summary calculations

-- per capita:

95th Percentile 99th Percentile 99.9th Percentile Exposure % aPAD Exposure % aPAD Exposure % aPAD

---------- -------- ---------- -------- ---------- -------- Total US Population: 0.012053 1.86 0.027646 4.26 0.063099 9.72 All Infants: 0.027189 4.19 0.049979 7.70 0.099471 15. 32 Children 1

- 2: 0.043572 6.71 0.076449 11.77 0.124100 19.11 Children 3

- 5: 0.032295 4.97 0.055511 8.55 0.095302 14.68 Children 6

- 12: 0.018813 2.90 0.0365 79 5.63 0.065496 10.09 Youth 13

- 19: 0.009850 1.52 0.018822 2.90 0.030655 4.72 Adults 20

- 49: 0.007959 1.23 0.015938 2.45 0.029974 4.62 Adults 50

- 99: 0.008760 1.35 0.015938 2.45 0.029573 4.55 Female 13

- 49: 0.008637 61.69 0.016868 120.48 0.027960 199.71Thi ram Dietary Exposure and Risk Assessment DP # 418045

____________________________________________________________________________________________________________________

Page 13 of 14 

### Attachment 3

- Residue Inputs for Chronic Dietary Assessment of Thiram

File name: C: \ Documents and Settings \ tmorton \ My Documents \ MyFiles \ DEEM Files \ 079801 Thiram \ Thiram on Avocado \ 079801 Chronic Avg FT.TXT Chemical: Thiram RfD(Chronic): .015 mg/kg bw/day NOEL(Chronic): 0 mg/kg bw/day RfD(Acute): 0 mg/kg bw/day NOEL(Acute): 0 mg /kg bw/day Date created/last modified: 02

- 10

- 2014/09:53:01 Program ver. 3.16, 03

- 08

- d

----------------------------------------------------------------------------------- EPA Crop Def Res Adj.Factors Comm ent Code Grp Commodity Name (ppm) #1 #2

---------- ---- ------------------------------- ---------- ------ ------ ------- 1100007000 11 Apple, fruit with peel 3.7 3 0000 0.790 1.000 1100008000 11 Apple, peeled fruit 3.7 3 0000 0.790 1.000 1100008001 11 Apple, peeled fruit

- babyfood 3.7 3 0000 0.790 1.000 1100009000 11 Apple, dried 3.7 3 0000 2.400 1.000 1100009001 11 Apple, dried

- babyfood 3.7 3 0000 2.400 1.000 1100010000 11 Apple, juice 3.7 3 0000 0.120 1.000 1100010001 11 Apple, juice

- babyfood 3.7 3 0000 0.120 1.000 1100011000 11 Apple, sauce 3.7 3 0000 0.18 0 1.000 1100011001 11 Apple, sauce

- babyfood 3.7 3 0000 0.180 1.000 1202260000 12B Peach 3.200000 0.790 1.000 1202260001 12B Peach

- babyfood 3.200000 0.180 1.000 1202261000 12B Peach, dried 3.200000 2.400 1.000 1202261001 12B Peach, dried

- babyfood 3.200000 2.400 1.000 1202262000 12B Peach, juice 3.200000 0.120 1.000 1202262001 12B Peach, juice

- babyfood 3.200000 0.120 1.000 1307359000 13G Strawberry 4.900000 0.420 1.000 1307359001 13G Strawberry

- babyfood 4.900000 0.180 1.000 1307360000 13G Strawberry, juice 4.900000 0. 120 1.000 1307360001 13G Strawberry, juice

- babyfood 4.900000 0.120 1.000 8601000000 86A Water, direct, all sources 0.002500 1.000 1.000 8602000000 86B Water, indirect, all sources 0.002500 1.000 1.000 9500020000 O Avocado 0.050000 1.000 1.000 Pulp R

Full comment: Pulp Residues 9500023000 O Banana 0.800000 1.000 1.000 9500023001 O Banana

- babyfood 0.800000 1.000 1.000 9500024000 O Banana, dried 0.800000 2.400 1.000 9500024001 O Banana, dried

- babyfood 0.800000 2.400 1.000 9500283000 O Plantain 0.800000 1.000 1.000 9500284000 O Plantain, dried 0.800000 2.400 1.000Thi ram Dietary Exposure and Risk Assessment DP # 418045

____________________________________________________________________________________________________________________

Page 14 of 14 

### Attachment 4

- Results of Partially Refined Chronic Dietary Analysis for Thiram

U.S. EPA Ver. 3.16, 03

- 08

- d
DEEM

- FCID Chronic analysis for THIRAM NHANES 2003

- 2008 2

- day Residue file name: C: \ Documents and Settings \ tmorton \ My Documents \ MyFiles \ DEEM Files \ 079801 Thiram \ Strawberry \ 079801 Chronic Average FT 100PCT Washing Studies Food And Water.R08 Adjustment factor #2 used. Analysis Date 02

- 12

- 2014/13:17:16 Residue file dated: 02

- 12

- 2014/13:15:36 Reference dose (RfD, Chronic) = .015 mg/kg bw/day

===================================================== ========================== Total exposure by population subgroup

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

Total Exposure

----------------------------------- Population mg/kg Percent of Subgroup body wt/day Rfd

-------------------------------------- ------- ------ ---------------- Total US Population 0.002257 15.0% Hispanic 0.003026 20.2%
Non

- Hisp

- White 0.002150 14.3%
Non

- Hisp

- Black 0.001847 12.3%
Non

- Hisp

- Other 0.002652 17.7% Nursing Infants 0.004460 29.7%
Non

- Nursing Infants 0.007655 51.0% Female 13+ PREG 0.001931 12.9% Children 1

- 6 0.008836 58.9% Children 7

- 12 0.003265 21.8 % Male 13

- 19 0.001428 9.5% Female 13

- 19/NP 0.001621 10.8% Male 20+ 0.001289 8.6% Female 20+/NP 0.001492 9.9% Seniors 55+ 0.001697 11.3% All Infants 0.006669 44.5% Female 13

- 50 0.001346 9.0% Children 1

- 2 0.012007 80.0% Children 3

- 5 0.007575 50.5% Children 6

- 12 0.003633 24.2% Youth 13

- 19 0.001523 10.2% Adults 20

- 49 0.001225 8.2% Adults 50

- 99 0.001653 11.0% Female 13

- 49 0.001335 8.9%

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