Thiram Dietary Exposure and Risk Assessment DP# 412466 

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

WASHINGTON, D.C. 20460 

Office of Chemical Safety and Pollution Prevention 

MEMORANDUM 

DATE: 11-December-2013 

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

Risk Assessment to Support a Petition For an Increased Tolerance on Strawberry. 

PC Code: 079801 

Decision No.: 471074 

Petition No.: 2F8106 

Risk Assessment Type: Dietary 

TXRNo.: NA 

MRIDNo.: NA 

FROM: Thurston G. Morton, Chemist 

Risk Assessment Branch IV 

Health Effects Division (7509P) 

DP No.: 041 2466 

Registration No.: NA 

Regulatory Action: NA 

Case No.: NA 

CASNo.: 137-26-8 t/--

40 CFR: SO.J;32 -

/ 

THROUGH: Doug Dotson, Senior Chemi 

Kristin Rury, Biologist ¥-

Dietary Exposure Science Advisory 

Health Effects Division (7509P) 

And 

Susan Hummel, Senior Scientist . 'f) 

Elissa Reaves, Ph.D., Branch Chief <:!:.~ t::==,_~"'---­ Risk Assessment Branch IV 

Health Effects Division (7509P) 

TO: Shaunta Hill 

Fungicide Branch 

Registration Division (7505P) 

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

Exposure Evaluation Model software with the Food Commodity Intake Database DEEMFCIDTM, Version 3.1 6. 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 tolerance increase on strawberry from 7 ppm to 20 ppm. 

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Thiram Dietary Exposure and Risk Assessment DP# 412466 

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

Operating Procedures (SOP) 2012.1. 

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

A refined probabilistic acute dietary-exposure assessment was performed using maximum 

percent crop treated (%CD provided by BEAD, tolerance, the highest residue found during 

field-trials, distribution of field trial residues, Federal Drug Administration (FDA) monitoring 

data for apples, 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 Envirorunental Fate and 

Effects Division (EFED). 

The resulting acute dietary risk estimates for food and drinking water are below RED's level of 

concern (i.e., <100% of the acute population adjusted dose; aPAD of0.6494 m~kg bw/day) for 

the general U.S. population and all population subgroups. Using DEEM-FCID M' acute dietary 

exposure at the 99 .9th exposure percentile is estimated at 0.020104 mg/kg bw/day for the general 

U.S. population (3 .1 % of the aP AD) and 0.010887 mglkg bw/day (78% of the aP AD) for 

females 13-49 years old, the population subgroup with the highest estimated acute dietary 

exposure to thiram. 

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

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

estimated %CT. 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 RED's level of concern 

(i.e., <100% ofthe chronic population adjusted dose; cPAD of0.015 mg/kg bw/day) for the 

general U.S. population and all population subgroups. Using DEEM-FCIDTM' dietary exposure is 

estimated at 0.001384 mg/kg bw/day for the general U.S. population (9.2% of the cPAD) and 

0.008369 mg/kg bw/day (56% ofthe 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 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 is concerned when estimated dietary risk 

exceeds 100% ofthe PAD. References that 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-12/606l.pdf; or see SOP 99.6 (20-

AUG-1999). 

The most recent dietary risk assessment for thiram was conducted by T. Morton (D405397, 

09/26/12). 

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Thiram Dietary Exposure and Risk Assessment DP# 412466

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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 of residues of thiram (tetramethyl thiuram disulfide) [40 CFR §180.132] and 

are established at 0.80 ppm for bananas and 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. 

FDA monitoring data from 1992-1999 are available for the EBDC class of pesticides for the 

following commodities: apples, pears, peaches, nectarines, tomatoes, and several of the small 

berries. The FDA utilizes the EBDC analytical method, which determines thiram residues along 

with a number of other pesticides due to the common moiety analytical method. Typically HED 

does not incorporate monitoring data of this age, but since neither FDA nor the United States 

Department of Agriculture (USDA) monitors the EBDC class of pesticides anymore, these data 

were incorporated into the dietary exposure assessment. In addition, the EBDCs are not stable if 

samples are not stored frozen. Therefore, the FDA monitoring data would be more 

representative of pesticide residues in food. The FDA monitoring data would likely overestimate 

residues since thiram, ziram, ferbam, and any EBDC will be measured/detected by this method. 

Field-trial data are available for all other crops. The dietary exposure assessment incorporated 

FDA monitoring data for residues found in apples. 

For apples, BEAD provided average %CT and maximum %CT of 5% and 10%CT estimates, 

respectively. FDA monitoring data from 1992 to 1998 are available for apples for EBDCs of 

which thiram is one. There were 76 samples of apples. There were 8 detects. 

RAC #Detects/#Sampled % Detects 1⁄2 LOD (ppm) 

weighted average

Total of Detects 

(ppm)

Chronic value (ppm)

Apple 8/76 10.5 0.0015 4.71 0.062

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 (dried 

apple, dried banana, and dried peach), a point-estimate was used consisting of the average fieldtrial residue incorporating the likely maximum estimated %CT. 

Chronic Anticipated Residues

Tolerances level residues and average %CT were used for the chronic dietary exposure analysis 

for all crops except for apples. 

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.
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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). Apple processing 

factors were translated to peach and strawberry, where applicable. The table below shows the 

results of these studies and the processing factors that were used to refine the acute and chronic 

assessments. The washing/processing factors were not used to refine the apple FDA monitoring 

data. Processing factors were not used for apple commodities, with the exception of dried apple 

for which an empirical factor of 2.4 was used.

Table 1. Processing Factors.

Type Factor 

Consumer practice (strawberry) 0.42

Washing (apple) 0.79

Drying (apple) 2.4

Sauce (apple) 0.18

Juice (apple) 0.12

Percent Crop Treated Information

BEAD provided estimated %CT information for thiram in its Screening Level Usage Analysis;

SLUA, 01/12/12). For the chronic analysis, average percent crop treated was incorporated; for 

the acute analysis, the estimated maximum %CT was used. 

The following maximum %CT estimates were used in the acute dietary risk assessment for the 

following crops that are currently registered for thiram: apples: 10%; peaches: 2.5%; and 

strawberry: 30%. The following average %CT treated estimates were used in the chronic dietary 

risk assessments for the following crops that are currently registered for thiram: apples: 5%; 

peaches: 1.0%; and strawberry: 20%. 
Thiram Dietary Exposure and Risk Assessment DP# 412466

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Table 2. Summary of Anticipated Residues for Thiram.

Commodity Classification1

Data 

Used2

Processing 

Factor

Percent Crop Treated3

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 FDA 1 5 10 RDF # 1

Apples

doc APPLES FDA 

%CPTX=10

TOTALZ=68

TOTALLOD=0

LODRES=0.0015

1.92, 0.41, 0.38, 0.29,

0.34, 0.58, 0.42, 0.37

7.0

Apple, peeled fruitbabyfoodPB FDA 1 5 10 RDF #1 7.0

Apple, dried

Apple, dried-babyfood 

B FDA 1 5 10 7.0 7.0

Apple, juice 

Apple, juice-babyfood

PB FDA 1 5 10 RDF # 1 7.0

Apple, sauce

Apple, sauce-babyfood

PB FDA 1 5 10 RDF # 1 7.0

Peach NB/PB FT 0.79 <1 2.5 RDF #2

'Peaches

'2.5% CT

TOTALZ=819

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

7.0

Peach, babyfood PB FT 0.18 <1 2.5 RDF #2 7.0

Peach, dried

Peach, dried - babyfood

B FT 2.4 <1 2.5 RDF #2 7.0

Peach, juice

Peach, juice - babyfood

PB FT 0.12 <1 2.5 RDF #2 7.0

Strawberry PB FT 0.42 20 30 RDF #3 New Data:

'Strawberries

'30% CT

TOTALZ=23 

TOTALNZ=10

3.45, 3.15, 4.30, 0.05

4, 11.4, 5.40, 5.3, 4.2

7.65

20

Strawberry - babyfood PB FT 0.18 20 30 RDF #3 20

Strawberry - juice

Strawberry, juice -

babyfood

PB FT 0.12 20 30 RDF #3 20
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Table 2. Summary of Anticipated Residues for Thiram.

Commodity Classification1

Data 

Used2

Processing 

Factor

Percent Crop Treated3

Residue Distribution for 

Acute Anticipated 

Residue

Chronic 

Anticipated 

Residue, ppm

Weighted

Avg.

Estimated 

Max

Banana, peeled fruit

Banana, peeled fruitbabyfood

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 = blended.

2 FT = field-trial data. 

3 Percent Crop treated information was provided by BEAD (K. Stebbins; 10/9/08; D356575).

III. 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 crop 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-FCIDTM 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 environment 

IV. DEEM-FCIDTM PROGRAM AND CONSUMPTION INFORMATION

Thiram acute and chronic dietary exposure assessments were conducted using the DEEMFCIDTM, 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 
Thiram Dietary Exposure and Risk Assessment DP# 412466

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events. Based on analysis of the 2003-2008 WWEIA consumption data, which took into account 

dietary patterns and survey respondents, HED concluded that it is most appropriate to report risk 

for the following population subgroups: the general U.S. population, all infants (<1 year old), 

children 1-2, children 3-5, children 6-12, youth 13-19, adults 20-49, females 13-49, and adults 

50-99 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 daily consumption estimate for that food/food form to produce a residue intake estimate. 

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

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

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

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

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

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

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

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

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

expressed as a percentage of the aPAD on both a user (i.e., only those who reported eating 

relevant commodities/food forms) and a per-capita (i.e., those who reported eating the relevant 

commodities as well as those who did not) basis. In accordance with HED policy, per capita 

exposure and risk are reported for all tiers of analysis. However, for tiers 1 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.
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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 

Assessment Study and Toxicological Effects

Acute Dietary

(General

Population)

BMDL10 =

64.94

mg/kg/day

UFA = 10x

UFH = 10x

FQPA SF = 1x

Acute RfD = 

0.6494

mg/kg/day

aPAD = 0.6494

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

UFA = 10x

UFH = 10x

FQPA SF = 1x

Acute 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

UFA = 10x

UFH = 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 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, 

inhalation)

“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 environmentally relevant human 

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

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

among members of the human population (interspecies). FQPA SF = FQPA Safety Factor. PAD = populationadjusted 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. 
Thiram Dietary Exposure and Risk Assessment DP# 412466

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Results of Acute Dietary-Exposure Analysis

A refined probabilistic acute dietary-exposure assessment was performed using %CT provided 

by BEAD, highest residue of field-trial residue values, FDA monitoring data for apples 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 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-FCIDTM, acute dietary exposure at the 99.9th exposure percentile is estimated at 0.020104

mg/kg bw/day for the general U.S. population (3.1% of the aPAD) and 0.010887 mg/kg bw/day 

(78% of the aPAD) for females 13-49 years old, the population subgroup with the highest 

estimated acute dietary risk to thiram. The estimated exposures/risks for combined food and 

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)

95th Percentile 99th Percentile 99.9th Percentile

Exposure 

(mg/kg/day)

% 

aPAD

Exposure 

(mg/kg/day)

% 

aPAD

Exposure 

(mg/kg/day)

% 

aPAD

General U.S. 

Population 0.6494 0.003419 <1 0.007029 1.1 0.020104 3.1

All Infants 

(<1 year old) 0.6494 0.010016 1.5 0.016352 2.5 0.040956 6.3

Children 1-2 

years old 0.6494 0.008983 1.4 0.024980 3.9 0.064254 9.9

Children 3-5 

years old 0.6494 0.005982 <1 0.014708 2.3 0.039745 6.1

Children 6-

12 years old 0.6494 0.003733 <1 0.008783 1.4 0.021715 3.3

Youth 13-19 

years old 0.6494 0.002718 <1 0.004989 <1 0.011129 1.7

Adults 20-49 

years old 0.6494 0.003017 <1 0.004806 <1 0.010891 1.7

Adults 50-99 

years old 0.6494 0.002807 <1 0.005012 <1 0.011093 1.7

Females 13-

49 years old 0.014 0.003074 22 0.005024 36 0.010887 78

* The values for the highest risk population for each percentile are bolded.

Results of Chronic Dietary-Exposure Analysis

The chronic dietary risk estimates for food and water combined are below HED’s level of 

concern (i.e., <100% of the cPAD of 0.015 mg/kg bw/day) for the general U.S. population and 

all population subgroups. Using the DEEM-FCID software, dietary exposure is estimated at 

0.001384 mg/kg bw/day for the general U.S. population (9.2% of the cPAD) and 0.008369

mg/kg bw/day (56% 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 

combined food and water are summarized in Table 6.
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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 0.001384 9.2

All Infants (<1 year old) 0.015 0.004443 30

Children 1-2 years old 0.015 0.008369 56

Children 3-5 years old 0.015 0.004947 33

Children 6-12 years old 0.015 0.002172 15

Youth 13-19 years old 0.015 0.000877 5.8

Adults 20-49 years old 0.015 0.000716 4.8

Adults 50-99 years old 0.015 0.000947 6.3

Females 13-49 years old 0.015 0.000823 5.5

* The values for the highest exposed population is bolded.

VII. DISCUSSION OF UNCERTAINTIES

Residues in all foods but apples 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. In 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. FDA monitoring data were used for apples. 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 Thiram

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 Thiram

Attachment 5 - Quantitative Usage Analysis

cc: T. Morton (RAB4)

T. Morton:S10838:PY-S:(703)305-6691:7509P:RAB4
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Attachment 1- Residue Inputs for Acute Dietary Assessment 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.TXT

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: 06-27-2013/14:34:13 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 FDA.rdf

 2 6 peach FT.rdf

 3 6 straw New FT.rdf

 EPA Crop Commodity Name Def Res Adj.Factors RDLComment

 Code Grp (ppm) #1 #2 Pntr

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

1100009000 11 Apple, dried 7.000000 2.400 1.000 

1100009001 11 Apple, dried-babyfood 7.000000 2.400 1.000 

1100007000 11 Apple, fruit with peel 7.000000 1.000 1.000 1 

1100010000 11 Apple, juice 7.000000 0.120 1.000 1 

1100010001 11 Apple, juice-babyfood 7.000000 0.120 1.000 1 

1100008000 11 Apple, peeled fruit 7.000000 1.000 1.000 1 

1100008001 11 Apple, peeled fruit-babyfood 7.000000 1.000 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 

9500020000 O Avocado 0.050000 1.000 1.000 Pulp R

 Full comment: Pulp Residues

9500023000 O Banana 0.276000 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 

9500023001 O Banana-babyfood 0.276000 1.000 1.000 

1202260000 12B Peach 6.420000 0.790 1.000 2 

1202261000 12B Peach, dried 6.420000 2.400 0.025 

1202261001 12B Peach, dried-babyfood 6.420000 2.400 0.025 

1202262000 12B Peach, juice 6.420000 0.120 1.000 2 

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

1202260001 12B Peach-babyfood 6.420000 0.180 1.000 2 

1307359000 13G Strawberry 11.400000 0.420 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 

1307359001 13G Strawberry-babyfood 11.400000 0.180 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 
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Attachment 2 - Results of Refined 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 file: 079801 Acute Tolerance HR for Banana Strawberry and Peach RDF for FDA Apple Plus 

Strawberry Apple Peach Washing Factor %CT.R08

 Adjustment factor #2 used.

Analysis Date: 06-27-2013/14:42:24 Residue file dated: 06-27-2013/14:34:13

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:

 0.003313 0.51 0.006352 0.98 0.015300 2.36 

All Infants:

 0.009300 1.43 0.013805 2.13 0.026753 4.12 

Children 1-2:

 0.007113 1.10 0.015297 2.36 0.039137 6.03 

Children 3-5:

 0.005171 0.80 0.010660 1.64 0.027975 4.31 

Children 6-12:

 0.003472 0.53 0.007204 1.11 0.017253 2.66 

Youth 13-19:

 0.002613 0.40 0.004869 0.75 0.009770 1.50 

Adults 20-49:

 0.002984 0.46 0.004685 0.72 0.009751 1.50 

Adults 50-99:

 0.002770 0.43 0.004970 0.77 0.010716 1.65 

Female 13-49:

 0.003054 21.81 0.004789 34.21 0.009975 71.25 
Thiram Dietary Exposure and Risk Assessment DP# 412466

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Attachment 3- Residue Inputs for Chronic Dietary Assessment of Thiram

Filename: C:\Documents and Settings\tmorton\My Documents\MyFiles\DEEM Files\079801 

Thiram\Strawberry\079801 Chronic Tolerance Plus % CT Food And Water.R08

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: 06-11-2013/07:49:58 Program ver. 3.16, 03-08-d

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

 EPA Crop Def Res Adj.Factors Comment

 Code Grp Commodity Name (ppm) #1 #2 

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

1100007000 11 Apple, fruit with peel 7.000000 1.000 0.050 

1100008000 11 Apple, peeled fruit 7.000000 1.000 0.050 

1100008001 11 Apple, peeled fruit-babyfood 7.000000 1.000 0.050 

1100009000 11 Apple, dried 7.000000 8.000 0.050 

1100009001 11 Apple, dried-babyfood 7.000000 8.000 0.050 

1100010000 11 Apple, juice 7.000000 1.300 0.050 

1100010001 11 Apple, juice-babyfood 7.000000 1.300 0.050 

1100011000 11 Apple, sauce 7.000000 1.000 0.050 

1100011001 11 Apple, sauce-babyfood 7.000000 1.000 0.050 

1202260000 12B Peach 7.000000 1.000 0.010 

1202260001 12B Peach-babyfood 7.000000 1.000 0.010 

1202261000 12B Peach, dried 7.000000 7.000 0.010 

1202261001 12B Peach, dried-babyfood 7.000000 7.000 0.010 

1202262000 12B Peach, juice 7.000000 1.000 0.010 

1202262001 12B Peach, juice-babyfood 7.000000 1.000 0.010 

1307359000 13G Strawberry 20.000000 1.000 0.200 

1307359001 13G Strawberry-babyfood 20.000000 1.000 0.200 

1307360000 13G Strawberry, juice 20.000000 1.000 0.200 

1307360001 13G Strawberry, juice-babyfood 20.000000 1.000 0.200 

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 3.900 1.000 

9500024001 O Banana, dried-babyfood 0.800000 3.900 1.000 
Thiram Dietary Exposure and Risk Assessment DP# 412466

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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 Tolerance Plus % CT Food And Water.R08

 Adjustment factor #2 used.

Analysis Date 06-11-2013/07:50:26 Residue file dated: 06-11-2013/07:49:58

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 0.001384 9.2%

Hispanic 0.001674 11.2%

Non-Hisp-White 0.001355 9.0%

Non-Hisp-Black 0.001163 7.8%

Non-Hisp-Other 0.001549 10.3%

Nursing Infants 0.003012 20.1%

Non-Nursing Infants 0.005082 33.9%

Female 13+ PREG 0.001104 7.4%

Children 1-6 0.005900 39.3%

Children 7-12 0.001955 13.0%

Male 13-19 0.000791 5.3%

Female 13-19/NP 0.000965 6.4%

Male 20+ 0.000706 4.7%

Female 20+/NP 0.000901 6.0%

Seniors 55+ 0.000996 6.6%

All Infants 0.004443 29.6%

Female 13-50 0.000827 5.5%

Children 1-2 0.008369 55.8%

Children 3-5 0.004947 33.0%

Children 6-12 0.002172 14.5%

Youth 13-19 0.000877 5.8%

Adults 20-49 0.000716 4.8%

Adults 50-99 0.000947 6.3%

Female 13-49 0.000823 5.5%

-------------------------------------------------------------------------------
Thiram Dietary Exposure and Risk Assessment DP# 412466

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Attachment 5 - Quantitative Usage Analysis

Thiram (079801)

Screening Level Usage Analysis (SLUA)

Date: January 12, 2012

What is a Screening Level Usage Analysis (SLUA)?

Available estimates of pesticide usage data for a particular active ingredient that is 

used on agricultural crops in the United States.

Pesticide usage data obtained from various sources. The data are then merged, 

averaged, and rounded so that the presented information is not proprietary, business 

confidential, or trade secret. 

What does it contain?

Pesticide usage data for a single active ingredient only.

Agricultural use sites (crops) that the pesticide is reported to be used on.

Available pesticide usage information from U.S. states that produce 80% or more of a 

crop, in most cases, or less than 80%, in rare cases, depending on the scope of the 

survey and available resources.

Annual percent of crop treated (average & maximum) for each agricultural crop.

Average annual pounds of the pesticide applied for each agricultural crop (i.e., for the 

states surveyed, not for the entire United States).

What assumptions can I make about the reported data?

Average pounds of active ingredient applied - Values are calculated by merging 

pesticide usage data sources together; averaging across all observations, then 

rounding. Note: If the estimated value is less than 500, then that value is labeled 

<500. Estimated values between 500 & <1,000,000 are rounded to 1 significant 

digit. Estimated values of 1,000,000 or greater are rounded to 2 significant digits.)

Average percent of crop treated - Values are calculated by merging data sources 

together; averaging by year, averaging across all years, & rounding to the nearest 

multiple of 5. Note: If the estimated value is less than 2.5, then the value is labeled 

<2.5. If the estimated value is less than 1, then the value is labeled <1.

Maximum percent of crop treated - Value is the single maximum value reported 

across all data sources, across all years, & rounded up to the nearest multiple of 5. 

Note: If the estimated value is less than 2.5, then the value is labeled <2.5.

What are the data sources used?

USDA-NASS (United States Department of Agriculture’s National Agricultural 

Statistics Service) – pesticide usage data from 2003 to 2010.

Private pesticide market research – pesticide usage data from 2003 to 2010.

California Department of Pesticide Regulation (DPR) Pesticide Use Reporting

(PUR) data for 2003 to 2009.

What are the limitations to the data?

Additional registered uses may exist but are not included because the available 

surveys do not report usage (e.g., small acreage crops).

Lack of reported usage data for the pesticide on a crop does not imply zero usage.

Usage data on a particular site may be noted in data sources, but not quantified. In 

these instances, the site would not be reported in the SLUA.
Thiram Dietary Exposure and Risk Assessment DP# 412466

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Non-agricultural use sites (e.g., turf, post-harvest, mosquito control, etc.) are not 

reported in the SLUA. A separate request must be made to receive these estimates.

Some sites show some use, even though they are not on the label. This usage could 

be due to various factors, including, but not limited to Section 18 requests, existing 

stocks of the chemical, data collection errors, and experimental use permits (EUPs). 

 

Thursday, January 12, 2012

Screening Level Estimates of Agricultural Uses of Thiram (079801)

Sorted Alphabetically

 

Percent Crop Ttd.

Crop Lbs. A.I. Avg. Max.

1 Apples 60,000 5 10

2 Cotton (Seed Treatment) <500 <1 <2.5

3 Peaches 2,000 <1 <2.5

4 Soybeans (Seed Treatment) 20,000 <1 <2.5

5 Strawberries 50,000 20 30

6 Sugar Beets (Seed Treatment) <500 <2.5 <2.5

7 Wheat (Seed Treatment) 13,000 <2.5 <2.5

All numbers rounded.

<500 Less than 500 pounds of active ingredient

<2.5 Less than 2.5 percent of crop treated

<1 Less than 1 percent of crop treated

SLUA data sources include: 

USDA-NASS (United States Department of Agriculture's National Agricultural Statistics 

Service)

Private Pesticide Market Research

California DPR (Department of Pesticide Regulation)

These results reflect amalgamated data developed by the Agency and are releasable to the public.