Thiram Dietary Exposure and Risk Assessment DP# 427382 

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

WASHINGTON, D.C. 20460 

Office of Chemical Safety and Pollution Prevention 

MEMORANDUM 

DA TE: 21-May-2015 

SUBJECT: Thiram: Revised Acute and Chronic Dietary (Food and Drinking Water) 

Exposure and Risk Assessment to Support a Petition for the Conversion of the 

Time-Limited Banana Tolerance to Permanent and Import use on Avocado. 

PC Code: 07980 I 

Decision No.: 488085 

Petition No.: 4E8250 

Risk Assessment Type: Dietary 

TXR No.: NA 

MRJD No.: NA 

FROM : Thurston G. Morton, Chemist 

Risk Assessment Branch IV 

Health Effects Division (7509P) 

DP No.: 0427382 

Registration No.: NA 

Regulatory Action: Tolerance, no registration 

Case No.: 0122 

CAS No.: 137-26-8 

40CFR: §180.132 

<7dl'JA~c 

T HROUGH: Doug Dotson, PhD., Senio C emist 4-. /)~ Kristin Rury, Biologist i ,../~ . ~ 

Dietary Exposure Science dvisoro/' Council (MSAC) 

Health Effects Division (7509P) 

And 

Charles 

Health 

Risk Assessment 

Effects 

Smith, 

Division 

Branch 

Branch 

Chief 

(7509P) 

IV 

C-~ 

TO: Driss Benmhenol 

Rachel Holloman, Branch Chief 

Registration Division (7505P) 

Revised thiram acute and chronic dietary (food and drinking water) exposure assessments were 

conducted using the Dietary Exposure Evaluation Model software with the Food Commodity 

Intake Database DEEM-FCIDTM, 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 analyses 

were performed to evaluate the proposed new use of avocado and conversion of the time-limited 

tolerance on bananas to a permanent tolerance. 

Page I of 15 
Thi ram Dietary Exposure and Risk Assessment DP# 427382 

This memorandum was reviewed by two peer reviewers of the DESAC, per DESAC Standard 

Operating Procedure (SOP) 201 2.1. 

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

A partially refined probabilistic acute dietary-exposure assessment was performed using 100 

percent crop treated (%CT), average field trial residues or pulp residues for blended 

commodities, distributions of field trial residues, highest pulp residue, and empirical processing 

factors. Dietary risk estimates were determined considering exposures from food and drinking 

water using estimated drinking water concentrations (EDWCs) for surface water sources 

provided by the Environmental Fate and Effects Division (EFEO). 

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 population subgroups (including females 13-49 years old; aPAD of 0.014 mg/kg bw/day). 

Using DEEM-FCID, acute dietary exposure at the 95th exposure percentile is estimated at 

0.012002 mg/kg bw/day for the general U.S. population (1.9% of the aPAD) and 0.008595 

mg/kg bw/day (61 % of the aP AD) for females 13-49 years old, the population subgroup with the 

highest percent aPAO. 

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

A partially refined chronic dietary-exposure assessment was performed using tolerances, average 

field trial residues, highest pulp residue for avocado, the proposed 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 drinking water are below HED's level of 

concern (i.e., <100% of the chronic population adjusted dose; cPAD of 0.015 mg/kg bw/day) for 

the general U.S. population and all population subgroups. Using DEEM-FCID, dietary exposure 

is estimated at 0.00 1999 mg/kg bw/day for the general U.S. population ( 13% of the cPAD) and 

0.010557 mg/kg bw/day (70% of the cPAD) for children 1-2 years old, the population subgroup 

with the highest estimated chronic dietary exposure 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 PAO. 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 is concerned when estimated dietary risk 

exceeds I 00% of the PAO. References that discuss the acute and chronic risk assessments in 

more detai I are available on the EPA/pesticides web site: "Available Information on Assessing 

Exposure from Pesticides, A User's Guide," 2 l-JUN-2000, web link: 

http://www.epa.gov/fedrgstr/EPA-PEST/2000/July/Day-12/606 I .pdf; or see SOP 99.6 (20-

AUG-1999). 

The most recent dietary risk assessment for thiram was conducted by T. Morton (0423339, 

2/24/ 14). 

Page 2 of 15 
Thi ram Dietary Exposure and Risk Assessment DP# 427382 

II. RESIDUE INFORMATION 

Residue Data used for Acute and Chronic Assessments 

Established Tolerances: Tolerances for residues in/on food and feed commodities are currently 

expressed in terms ofresidues of thiram (tetramethyl thiuram disulfide) [40CFR§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 

used 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-estimates consisting of the average field-trial 

residue were used. Empirical processing factors were also used. In addition, the assessment 

assumed 100% of the crops were treated with thiram. 

Chronic Anticipated Residues 

Avocado pulp residues, and average field trial residues for apples, bananas (pulp), peaches and 

strawberries along with l 00% 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, 2009, 

and 2010. 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 registrant (F. Fort, D283996, 04/20/03). 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 used 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 chroni c 

assessments. 

Table I. 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 

Page 3of15 
Thi ram Dietary Exposure and Risk Assessment DP# 427382 

Percent Crop Treated Information 

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

Table 2. S umma ry of Anticipated R esidues for T hiram. 

Percent Croo Treated3 Residue Distribution for Chronic 

Data Processing Weighted Estimated Acute Anticipated Anticipated 

Commodity Classification 1 Used2 Factor Avg. Max Residue Residue, ppm 

Avocado NB/PB FT I 100 100 0.05 highest pulp residue 0.05 

Apple. fruit with peel B/PB FT 0.79 100 100 RDF # I 3.7 

Apple. peeled fruit 

Apples 

'Apples 

'lOOt Ct 

TOTALZ=O 

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 

Apple, peeled fruit- PB FT 0.79 100 100 RDF # I 3.7 

baby food 

Apple. dried B FT 2.4 100 100 3.72 average of field 3.7 

Apple. dried-babyfood trials 

Apple, juice PB FT 0. 12 100 100 RDF # I 3.7 

Apple, juicc-babyfood 

Apple. sauce PB FT 0. 18 100 100 RDF # I 3.7 

Apple, saucc-babyfood 

Peach NB/PB FT 0.79 100 100 RDF #2 3.2 

'Peaches 

100%CT 

TOTA.LZ= IOO 

TOTALNZ=2 1 

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 

1.9 1 

Peach. babyfood PB FT 0. 18 100 100 RDF #2 3.2 

Peach. dried B FT 2.4 100 100 3.26 average of field 3.2 

Peach. dried - babyfood trials 

Peach. juice PB FT 0. 12 100 100 RDF #2 3.2 

Peach, juice - babyfood 

Strawberry PO FT 0.42 100 100 RDF #3 New Data: 4.9 

'Strawberries 

' 100%CT 

TOTA.LZ=O 

TOTALNZ= IO 

3.45. 3. 15. 4.30. 0.05 

4, 11 .4. 5.40. 5.3, 4.2 

Page 4of15 
Thiram Dietary Exposure and Risk Assessment DP# 427382 

Table 2. Summa ry of Anticipated Residues for T hiram. 

Percent Croo Treated3 Residue Distribution for Chronic 

Data Processing Weighted Estimated Acute Anticipated Anticipated 

Commodity Classification 1 Used2 Factor Avg. Max Residue Residue, ppm 

7.65 

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

Strawberry - juice PB FT 0.12 100 100 RDF #3 4.9 

Strawberry, juice -

baby food 

Banana, peeled fruit NB/PB FT 1.0 100 100 Bananas (pulp) 0.119 

Banana, peeled fruitbabyfood 

Banana, dried B FT 

Banana, dricd-babyfood 

1 NB= Non-blended; PB = partially blended; B = blended. 

2 FT= field-trial data 

Ill. Drinking Water Data 

2.4 

0.276 max residue average 

used pulp residue 

100 100 0. 119 0. 119 

The current action will not affect the EDWCs, therefore, the previous drinking water assessment 

(J. Carleton and F. Jenkins, 12111/03) 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 

highest 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 0.0478 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 Huma n-Hea lth Risk Assessment. 

Ann ua l 

App Rate SCI GROW PRZM/EXAMS* PRZ M/EXAM S* 

(lbs concen tration Acute EDWC non-ca ncer chronic 

Crop ai/acr e/vr) (nnb) (nnb) EDWC <oob) 

Turf farm 146.6 0.84 47.8 2.5 

* Index Reservoir environment 

IV. DEEM-FCJDTM 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 linked to EPA-defined food commodities (e.g. apples, peeled fruit - cooked; fresh or N/S; 

baked; or wheat flour - cooked; fresh or N/S, baked) using publicly available recipe translation 

files developed jointly by USDA/ ARS and EPA. For chronic exposure assessment, consumption 

data are averaged for the entire U.S. population and within population subgroups, but for acute 

exposure assessment are retained as individual consumption events. Based on analysis of the 

2003-2008 WWEIA consumption data, which took into account dietary patterns and survey 

Page 5of15 
Thi ram Dietary Exposure and Risk Assessment DP# 427382 

respondents, HED concluded that it is most appropriate to report risk for the following 

population subgroups: the general U.S. population, all infants (< l 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 foodform (e.g., orange or orange juice) on the food commodity residue list is multiplied by the 

average dai ly consumption estimate for that food/food form to produce a residue intake estimate. 

The resulting residue intake estimate for each food/food form is summed with the residue intake 

estimates for all other food/food forms on the commodity residue list to arrive at the total 

average estimated exposure. Exposure is expressed in mg/kg body weight/day and as a percent 

of the cPAD. This procedure is performed for each population subgroup. 

For acute exposure assessments, individual one-day food consumption data are used on an 

individual-by-individual basis. The reported consumption amounts of each food item can be 

multiplied by a residue point estimate and summed to obtain a total daily pesticide exposure for a 

deterministic exposure assessment, or "matched" in multiple random pairings with residue values 

and then summed in a probabilistic assessment. The resulting distribution of exposures is 

expressed as a percentage of the aP AD 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 l and 2, any significant 

differences in user vs. per capita exposure and risk are specifically identified and noted in the 

risk assessment. 

V. TOXICOLOGICAL INFORMATION 

A summary of the toxicological endpoints and doses chosen for the relevant exposure scenarios 

for human risk assessment are found in Table 4. 

Page 6of15 
Thi ram Dietary Exposure and Risk Assessment DP# 427382 

Table 4. Summa rv ofToxicolo!!ical Doses a nd Endooints for Thiram for Use in Dietarv Risk Assessments. 

RID, PAD, 

Exposure/ Point of Uncertainty/FQPA LOC for Risk 

Scena rio Departure Safetv Fa ctors Assessment Studv and Toxicolo!!ical Effects 

Acute Dietary BMDL10= UFA = I Ox Acute RID = Acute Neurotoxicity Study - Rat 

(General 64.94 UFH = I Ox 0.6494 LOAEL = 150 mg/kg/day based on 

Population) mg/kg/day FQPA SF = Ix mg/kg/day FOB effects (lethargy, lower 

temperature, reduced startle 

aPAD = 0.6494 response, no tai l pinch response), 

mg/kg/day reduced motor activity, and 

reduced brain weights. 

Acute Dietary NOA EL = 1.4 UFA = I Ox Acute RID = Dev. Neurotoxicity Study - Rat 

(Females 13- mg/kg/day UFH = I Ox 0.014 LOAEL = 3.7 mg/kg/day based on 

49 years old) FQPA SF = Ix mg/kg/day increases in motor activity seen in 

female offspring on PND 17 

aPAD =0.014 

mg/kg/day 

Chronic NOAEL = 1.5 UFA = I Ox Chronic RID = Combined Chronic 

Dietary mg/kg/day UFH = I Ox 0.015 Toxicity/Carcinogenicity Study -

(All FQPA SF = Ix mg/kg/day Rat & Chronic Oral Toxicity Study 

populations) - Dog 

cPAD =0.015 LOAEL = 7.3 mg/kg/day based on 

mg/kg/day changes in hematology, c linical 

chemistry, incidences of bile 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 

dogs at 2.6 mg/kg/day 

Cancer (oral, 

dermal, "Not Likely to be Carcinogenic to Humans" 

inhalation) 

Pomt of Departure (POD) = A data pomt or an estimated pomt that 1s derived from observed dose-response data and 

used to mark the beginning of extrapolation to determine risk associated with lower environmentally relevant human 

exposures. NOAEL = no-observed adverse-effect level. LOA EL = lowest-observed adverse-effect level. UF = 

uncertainty factor. UFA= extrapolation from animal to human (intraspecies). UF1-1 = potential variation in sensitivity 

among members of the human population (interspecies). FQPA SF = FQPA Safety Factor. PAD = populationadjusted dose (a = acute, c = chronic). RID = 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 PAO. 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 (< I year old), chi ldren 1-2, children 3-5, 

children 6-12, youth 13-19, females 13-49, adults 20-49, and adults 50-99 years old. 

Page7ofl5 
Thiram Dietary Exposure and Risk Assessment DP# 427382 

Results of Acute Dietary-Exposure Analysis 

A partiall y refined probabilistic acute dietary-exposure assessment was performed using 100 

%CT, average residue of field-trial residue values for blended commodities, distribution of field 

trial residues, highest pulp residues, and empirical processing factors. Dietary risk estimates 

were determined considering exposures from food plus drinking water using 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 of0.6494 mg/kg bw/day) for the general U.S. population and 

all population subgroups (including females 13-49 years old; aP AD of 0.014 mg/kg bw/day). 

Using DEEM-FCID, acute dietary exposure at the 95ih exposure percentile is estimated at 

0.012002 mg/kg bw/day for the general U.S. population (l.9% of the aPAD) and 0.008595 

mg/kg bw/day (6 1 % of the aPAD) for females 13-49 years old, the population subgroup with the 

highest % aPAD dietary exposure to 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). 

95•h Percentile 

Population a PAD Exposure 

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

General U.S. 

Population 0.6494 0.012002 1.9 -

All Infants 

(<l year old) 0.6494 0.027 109 4.2 

Children 1-2 

years old 0.6494 0.043503 6.7 -

I Children 3-5 

years old 0.6494 0.032302 5.0 >----

Children 6-

12 years old 0.6494 0.018667 2.9 - Youth 13- 19 

years old 0.6494 0.00985 1 1.5 

Adults 20-49 

years old 0.6494 0.007907 1.2 

Adults 50-99 

years old 0.6494 0.008705 1.3 - Females 13-

49 years old 0.0 14 0.008595 61 

• 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 of concern (i.e., <100% of the cPAD of0.015 mg/kg bw/day) for the general U.S. 

population and all population subgroups. Using the DEEM-FCTD software, dietary exposure is 

estimated at 0.00 1999 mg/kg bw/day for the general U.S. population (13% of the cPAD) and 

0.0 10557 mg/kg bw/day (70% 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 

Page 8of 15 
Thiram Dietary Exposure and Risk Assessment DP# 427382 

food and drinking water are summarized in Table 6. 

Table 6. Summary of Chronic Dietary Exposure and Risk fo r T hi ram (Food + Water). 

Age Group cPAD (mg/kg/day) Exposure (mg/kg/day) %cPAD 

General U.S. Population 0.0 15 0.001999 13 

All Infants (< I year old) 0.015 0.005387 36 

Children 1-2 years old 0.0 15 0.010557 70 

Children 3-5 years old 0.015 0.006870 46 

Children 6- 12 years old 0.015 0.003359 22 

Youth 13-19 years old O.QIS 0.00 1413 9.4 

Adults 20-49 years old 0.0 15 0.001077 7.2 

Adults 50-99 years old 0.015 0.00 1421 9.5 

Females 13-49 years old 0.01 5 0.001186 7.9 

* 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. Jn 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 

underestimate risk to the general U.S. population or any population subgroup. 

VIII. LIST OF ATTACHMENTS 

Attachment 1- Residue Inputs for Acute Dietary Assessment of Thi ram 

Attachment 2 - Results of Refined Acute Dietary Analysis for Thiram 

Attachment 3- Residue Inputs for Chronic Dietary Assessment of Thiram 

Attachment 4 - Results of Partially Refined Chronic Dietary Analysis for Thi ram 

cc: T. Morton (RAB4) 

T. Morton:S I 0838:PY-S:(703)305-669 l :7509P:RAB4 

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Thi ram Dietary Exposure and Risk Assessment DP# 427382 

Attachment 1- Residue Inputs for Acute Dietary Assessment of Thi ram 

Filename: C:\Users\tmor ton\Oocuments\My Files\DEEM Files\079801 Thiram\Banana and Avocado 

Rerun\079801 Acute Food and Water.ROS 

Chemical : Thiram 

RfD(Chronic): .015 mg/kg bw/day NOEL(Chronic): O mg/kg bw/day 

RfD(Acute) : .6494 mg/kg bw/day NOEL(Acute) : O mg/kg bw/day 

Date created/last modified: 12-16-2014/11:10:41 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 F1' lOOCT.rdf 

3 6 straw New F1' lOOCT.rdf 

EPA Crop Commodity Name Def Res Adj.Factors ROLComment 

Code Grp (ppm) Ill #2 Pntr 

---------- ------------------------------- --·------- ------- 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 

1100008001 11 Apple, peeled fruit- babyfood 7.000000 0.790 1.000 1 

1100009000 11 Apple, dried 3 .720000 2.400 1 . 000 

1100009001 11 Apple, dried- babyfood 3.720000 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-baby food 6.420000 0 .180 1.000 2 

1202261000 128 Peach, dried 3.260000 2 .400 1.000 

1202261001 128 Peach , dried-babyfood 3 . 260000 2.400 1.000 

1202262000 128 Peach, juice 6.420000 0 . 120 1.000 2 

1202262001 128 Peach, juice-babyfood 6.420000 0.120 1.000 2 

1307359000 13G Strawberry ll. 400000 0.420 1.000 3 

1307359001 13G Strawberry- baby food 11.400000 0.180 1.000 3 

1307360000 13G Strawberry, juice 11.400000 0 . 120 1.000 3 

1307360001 13G Strawberry, juice-babyfood ll.400000 0.120 1. 000 3 

8601000000 86A Water, direct, all sources 0 . 047800 1.000 1.000 

8602000000 86B Water, indirect, a ll sources 0.047800 1.000 1. 000 

9500020000 0 Avocado 0.050000 1. 000 1 .000 Pulp R 

Full comment: Pulp Residues 

9500023000 0 Banana 0.276000 1.000 1.000 Pulp R 

Full comment: Pulp Residues 

9500023001 0 Banana- babyfood 0.276000 1.000 1.000 Pulp R 

Full comment: Pulp Residues 

9500024000 0 Banana, dried 0 .119000 2.400 1.000 Pulp R 

Full comment: Pulp Residues 

9500024001 0 Banana, dried-babyfood 0 .119000 2.400 1.000 Pulp R 

Full comment: Pulp Residues 

9500283000 0 Plantain 0.276000 1.000 1 .000 

9500284000 0 Plantain, dried 0 . 27600 0 2.400 1. 000 

Page 10of1 5 
Thi ram Dietary Exposure and Risk Assessment 

Residue Distribution Files (rdfs) 

RDF #1 

'Apples 

'100\- Ct 

TOTALZ=O 

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=O 

TOTALNZ=21 

3.29 

6 .4 2 

3.04 

3. 4 7 

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=O 

TOTALNZ=lO 

3.45 

3.15 

4.30 

0.05 

4 

11.4 

5.40 

5.3 

4.2 

7.65 

Page 11 of 15 

DP# 427382 
Thi ram Dietary Exposure and Risk Assessment OP# 427382 

Attachment 2 - Results of Acute Dietary Analysis for Thi ram 

us EPA Ver. 3.18, 03-08-d 

DEEM- FCI D ACUTE Analysis for THIRAM Nt!ANES 2003 - 2008 2-Day 

Residue file: 079801 Acute Food and Water.ROS Adjustment factor tt2 u sed. 

Analysis Date: 05-20-2015/08:48:47 Residue file dated: 05-20-2015/08:29:07 

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 = 10821; RNG = MS VB 

Run Comment: "" 

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

Summary calculations--per capita : 

95th Percentile 99th Percentile 99.9th Percentile 

Exposure \ a PAD Exposure \ aPAD Exposure \ aPAD 

---------- -------· ... -....... --..... - -------- ---------- -------· 

Total us Population : 

0 . 012002 l. 85 0.027461 4 . 23 0 . 063009 9.70 

All Infants: 

0 . 027109 4. 1 7 0 . 049614 7.64 0.094657 14. 58 

Children 1-2: 

0.043503 6.70 0.076468 ll. 78 0.124955 19.24 

Children 3-5 : 

0.032302 4.97 0 . 055347 8.52 0 .095417 14. 69 

Children 6-12: 

0.018667 2 . 87 0.036479 5 . 62 0.065747 10.12 

Youth 13-19: 

0.009851 l. 52 0 . 018809 2.90 0 . 0302 95 4 . 67 

Adults 20 - 49: 

0.007907 l . 22 0.015890 2. 45 0 . 029075 4.48 

Adults 50-99: 

0 . 008705 l. 34 0 .015894 2. 45 0.029378 4.52 

Female 13-49: 

0.008595 61. 39 0.016835 1 20.25 0 . 027699 197.85 

FOOD ONLY 

us EPA Ver. 3.18, 03-08-d 

DEEM-FCID ACurE Analysis for THIRAM Nt!ANES 2003-2008 2-0ay 

Residue file: 07 9801 Acute Food Only . ROB Adjustment factor ~2 used. 

Analysis Date: 05-20-2015/09:04:07 Residue file d a ted: 05-20-2015/08 : 29:32 

Acute Pop Adjusted Dose (aPAD) varies with population; see individual reports 

RAC/ FF intake summed over 24 hour s 

MC iterations = 1000 ; MC list in r e s i d ue file ; MC s eed = 10821; RNG = MS VB 

Run Comment : " " 

== ==== ======= ========== ===~••== == === ==== ~aa a= ==== === ===== =:===== === == ==== =~ ••• 

Summary calculations--per capita : 

9Sth Percentile 99th Percentile 99.9th Percentile 

Exposure \ a PAD Exposure \ aPAD Exposure \ aPAD 

---------- ........... ........... ........................... -------- .................. --... -------- Total us Population : 

0 . 010689 l . 65 0.025967 4. 00 0 . 061 0 18 9. 40 

All Infants: 

0.024158 3 . 72 0.046598 7.18 0.092802 14 .29 

Children l-2 : 

0 . 041812 6 . 44 0 . 074672 ll.50 0 .122934 18 .93 

Children 3-5: 

0.030800 4. 74 0.053764 8.28 0.092509 14.25 

Children 6-12 : 

0 . 017630 2 . 71 0.034989 5. 39 0.063454 9.77 

Youth 13 -19: 

0 . 008878 l. 37 0.017645 2 . 72 0.0293 85 4.52 

Adults 20-49: 

0.006629 l.02 0.014500 2.23 0.027338 4.21 

Adults 50-99: 

0 . 007582 l.17 0 . 0 14508 2.23 0.027807 4.28 

Female 13-4 9: 

0 . 007290 52 . 07 0 . 015458 110 . 42 0 . 026198 187.13 

Page 12of 15 
Thi ram Dietary Exposure and Risk Assessment DP# 427382 

Attachment 3- Residue Inputs for Chronic Dietary Assessment ofThiram 

Filename : C: \Users\tmorton\Documents\My Files\DEEM Files\079801 Thiram\Banana and Avocado 

Rerun\079801 Chronic Food And Water.ROS 

Chemical: Thiram 

RfD(Chronicl: .015 mg/kg bw/day NOEL(Chronic): O mg/kg bw/day 

RfD(Acute): O mg/kg bw/day NOEL(Acute): O mg/kg bw/day 

Date created/last modified: 12-16-2014 / 11:12:06 Program ver. 3.16, 03-08-d 

EPA Crop 

Code Grp Commodity Name 

1100007000 11 

1100008000 11 

1100008001 11 

1100009000 11 

1100009001 11 

1100010000 11 

1100010001 11 

1100011000 11 

1100011001 11 

1202260000 12B 

1202260001 12B 

1202261000 12B 

1202261001 12B 

1202262000 12B 

1202262001 12B 

1307359000 13G 

1307359001 13G 

1307360000 13G 

1307360001 13G 

8601000000 86A 

8602000000 86B 

9500020000 0 

Apple, fruit with peel 

Apple, peeled fruit 

Apple, peeled fruit-babyfood 

Apple, dried 

Apple, dried-babyfood 

Apple, juice 

Apple, juice-babyfood 

Apple, sauce 

Apple, sauce-babyfood 

Peach 

Peach-baby food 

Peach, dried 

Peach, dried-babyfood 

Peach, juice 

Peach, juice-babyfood 

Strawberry 

Strawberry- babyfood 

Strawberry, juice 

Strawberry, juice-babyfood 

Water, direct, all sources 

Water, indirect, all sources 

Avocado 

Full comment: Pulp Residues 

9500023000 0 Banana 

Full comment: Pulp Residues 

9500023001 O Banana-babyfood 

Full comment: Pulp Residues 

9500024000 O Banana, dried 

Full comment: Pulp Residues 

9500024001 O Banana, dried-babyfood 

Full comment: Pulp Residues 

9500283000 0 Plantain 

9500284000 0 Plantain, dried 

Def Res 

(ppm) 

Adj.Factors 

#1 112 

Comment 

3 . 720000 0 . 790 1.000 

3.720000 0 . 790 1.000 

3 . 720000 0 . 790 1.000 

3 . 720000 2.400 1 . 000 

3 . 720000 2.400 l.000 

3 . 720000 0.120 1.000 

3.720000 0 . 120 1.000 

3.720000 0 .180 1.000 

3.720000 0 . 180 1.000 

3.260000 0 .790 1.000 

3.260000 0.180 1.000 

3.260000 2.400 1.000 

3.260000 2.4 00 1.000 

3.260000 0 . 120 1.000 

3.260000 0 .120 1.000 

4.900000 0 .420 1.000 

4.900000 0.180 1 . 000 

4.900000 0 .120 1 . 000 

4.900000 0.120 1 . 000 

0 . 002500 l . 000 1.000 

0.002500 1.000 1.000 

0.050000 l . 000 1.000 Pulp R 

0.119000 1 . 000 1.000 Pulp R 

0.119000 1 . 000 1.000 Pulp R 

0.119000 2 . 400 l.000 Pulp R 

0.119000 2 . 400 1.000 Pulp R 

0 . 121000 1. 000 1.000 

0.121000 2 . 400 1.000 

Page 13of 15 
Thi ram Dietary Exposure and Risk Assessment DP# 427382 

Attachment 4 - Results of Partially Refined Chronic Dietary Analysis for Thiram 

us EPA Ver. 3 . 16 , 03-08-d 

DEEM-FCID Chronic analysis for THI RAM NHANES 2003-2008 2-day 

Residue file name: C:\Users\tmorton \ Documents\My Files\DEEM Files\079801 Thiram\Banana and 

Avocado Rerun\079801 Chronic Food And Water.ROS 

Adjustment factor #2 used. 

Analysis Date 05-20-2015/08:32:48 Residue file dated: 05 - 20-2015/08 : 30 : 29 

Reference dose (RfD, Chronic) = .015 mg /kg bw/ day 

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

Total exposure b y population subgroup 

Population 

Subgroup 

Total US Population 

Hispanic 

Non-Hisp-White 

Non-Hisp-Black 

Non-Hisp-Other 

Nursing I nfants 

Non- Nursing Infants 

Female 13+ PREG 

Children 1-6 

Children 7-12 

Male 13-19 

Female 13- 19/NP 

Male 20+ 

Female 20+/NP 

Seniors 55+ 

All Infants 

Female 13-50 

Children 1-2 

Children 3-5 

Children 6-12 

Youth 13-19 

Adults 20 - 49 

Adults 50-99 

Female 13 - 49 

Total Exposure 

mg/kg 

body wt/day 

0.001999 

0.002621 

0 . 001912 

0.001667 

0 . 002337 

0.003534 

0 . 006214 

0 . 001699 

0.007919 

0.003014 

0. 001317 

0.001 510 

0. 001119 

0.0012 99 

0 . 001459 

0 . 005387 

0.001193 

0.010557 

0 . 006870 

0 .003 359 

0.001413 

0 .001077 

0.001421 

0 . 001186 

Page 14of1 5 

Percent of 

Rfd 

13 . 3\ 

17.5\ 

12.7\ 

11.1\ 

15 .6\ 

23 .6\ 

41.4\ 

11.3\ 

52.8\ 

20 . 1\ 

8.8\ 

10 .1\ 

7 .5 \ 

8. 7\ 

9.7\ 

35.9\ 

8.0\ 

70 . 4\ 

45 . 8\ 

22 .4\ 

9 .4\ 

7.2\ 

9.5\ 

7 .9\ 
Thi ram Dietary Exposure and Risk Assessment DP# 427382 

FOOD ONLY 

us EPA Ver. 3.16, 03-08-d 

DEEM-FCID Chronic analysis for THIRAM NHANES 2003 -2008 2-day 

Residue file name: C:\Users\tmorton\Documents\My Files\DEEM Files\079801 Thiram\Banana a nd 

Avocado Rerun\079801 Chronic Food Only.ROS 

Adjustment factor #2 used. 

Analysis Date 05-20-2015/08:33:07 Residue file dated: 05-20-2015/08:31:23 

Reference dose (RfD, Chronic) = .015 mg/kg bw/day 

======================•a=n•ac ================================================== 

Total exposure by population subgroup 

Population 

Subgroup 

Total us Population 

Hispanic 

Non-Hisp-White 

Non-Hisp-Black 

Non-Hisp-Other 

Nursing Infants 

Non-Nursing Infants 

Female 13+ PREG 

Children 1 - 6 

Children 7 - 12 

Male 13-19 

Female 13-19/NP 

Male 20+ 

Female 20+/NP 

Seniors 55+ 

All Infants 

Female 13-50 

Children 1-2 

Children 3-5 

Children 6 - 12 

Youth 13-19 

Adults 20- 4 9 

Adults 50-99 

Female 13-49 

Total Exposure 

mg/kg 

body wt/day 

0.001947 

0.002571 

0 . 001858 

0.001624 

0.002276 

0.003487 

0.006040 

0.001649 

0.007852 

0.002970 

0 . 001281 

0.001470 

0.001070 

0.001244 

0.001408 

0 . 005252 

0.001141 

0.010482 

0.006807 

0.003313 

0.001375 

0 . 001025 

0.001369 

0. 001134 

Page 15of15 

Percent of 

Rfd 

13.0t 

17. lt 

12 .4\' 

10. et 

15.2\' 

23.2\' 

40.3\' 

11. Ot 

52 . 3\ 

19.8\' 

8.5\' 

9.8\' 

7. lt 

8.3\' 

9. 4\' 

35.0t 

7.6\' 

69.9\' 

45.4\' 

22. lt 

9.2\' 

6.8\' 

9.1\' 

7.6\