Thiram Dietary Exposure and Risk Assessment 

### D P# 412466



### UNITED STATES ENV IRONM ENTAL PROTECTION AGENCY WASHINGTON, D.C. 20460

Office of Chemical Safety and Pollution Prevention



### MEMORANDUM

DATE: 11-December-2013



### SUBJECT: Thiram: Ac ut e and Chronic Dietary (Foo d and Drinking Water) Exposure and

Risk Assessment to Support a Petit i on For an Increa se d Tolerance on Strawberry.

PC Code : 07980 1

Dec i s ion No. : 471074

Petition No.: 2 F8 106

Risk Assessment Type: Dietary

TXRNo.: NA

MRIDNo.: NA



### FROM: T hurston G. Morton, Chemist

Risk Assessment Branch IV

Health Effects Divis i on (7509P) DP No

. : 041 2466 Registration No. : NA Regulatory Action: NA

Case No

. : NA



### CASNo.: 1 37-26

- 8 

# t/--

40 CFR : 

## SO.J;32

-**/**

THROUGH: Doug Dotson

, Senior Chemi

Krist in Rury, Biologist 

# ¥-

Dietary Ex posure Scie n ce Adv i so r y Health Effects Division (75 09P )

And



### Susan Hummel, Se nior Scientist

. 'f)



### E li ssa R eaves, Ph.D., Branch Chief

# <:!:.~**t::==,_~"'---­** Risk Assessment Branch IV

Health Effe cts Div ision (7509P)

TO: Sha u nta Hill Fungicide Branch Registration Division (750 5P)

Thiram acute and chronic dietary exposure assessments were co ndu cted using th e D i etary

Ex posure Eva lu at i o n Mode l software with the Food Commod ity Intake Database DEEMFC IDTM

, Versio n 3 .1 6. This software uses 2003-2008 food consump t ion data from the U.S. Depart m en t of Agriculture's (USDA's) Na tion al Healt h and N utr it i on Exami nati on Survey

, Wha t We Ea t in 

### America, (NHANES/WWE IA). The analyses we r e performed to ev aluate the proposed tolerance increase on st r awberry from 7 ppm to 20 ppm.

P age I of 16Thiram Dietary Exposure and Ri sk Assessment D P# 412466



### This memorandum was reviewed by two peer reviewers of the DESAC

, per DESAC Standard Operating Procedures (SOP) 20 12 .1.

Acute Dietary (Food and Drinking Water) Expos ure Re sults and Characterization

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

percent c r op treated (%CD provided by BEAD, toleranc e, the highest residue found during
field-trials, distribution of field trial residues

, Federal Drug Administ ra

tion (FDA) monitoring

data for apples, and empirical processing factors

. Dietary ri s k estimates were determined considering exposures from food and drinking water using estimate d drinking water
concentrations (EDWCs ) for surface water sources pro vided by the Envi rorun enta l Fa te and

Effects Division (EFED).

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

concern (i.e.

, < 100% of the acute popu l ation adjusted dose ; aPAD of0.6494**m~kg** 

### bw / day) for

the general U.S. population and all population su bgroups. Us ing DEEM-F CID M' acute dietary

exposure at the 99 .9th expos ur e 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 mglk g bw / day (78% of the 

### aP AD) for

females 13-49 years old

, the population subgrou p w it h the highest estimated acute dietary

exposure to thiram.

Chronic Dietary (Food and Drinking Water) E xposu r e Resu l ts and Characterization

A refined chronic dietar y-exposure assessment was per formed u sing tolerances and average estimated %CT

. Dietary risk est im ates were determined considering exposures from food and drinking water using EDWCs for surface water so urces provided by EFED. The resul t ing

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 populati on subgroups. Using DEEM-FCID TM' d i etary exposure is

estimated at 0.001384 mg/kg bw / day for th e gener al U.S. popu l at ion (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 high es t estimated chronic dietary exposure to thiram.



### I. INTRODUCTION

Dietary risk assessment in corporates both expos ure and toxicity o f a given pest i c ide. For acute

and chronic assessments

, the risk is expressed as a percent age of a maximum acceptable dose (i.e.

, the dose that HED has concluded will re s ult in no unreasonable adver se health effects).

This dos e is referred to as the PAD. The PAD is equivalent to point of departure (POD,

NO AEL

, LOAEL, e.g.) divided by the required uncertainty or safety factors.

Fo r acute and non-cancer chronic exposures
, HED is concerned whe n estimated di e tary risk

exceeds 100% ofthe PAD. References that discuss the acute and chronic risk assessments in

more detail are ava il able on the E PA/pesticid es web s it e: "Availa ble Information on Assessing Exposure from Pesticides

, A User's Guide," 2 1-J UN-2000, web link: http: //www .ep a. gov/ fedr gstr /EPA -PEST/2000/J u ly / D ay

- 12 / 6 06 l.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).

Page 2 ofl6Thiram Dietary Exposure and Risk Assessment DP # 412466

____________________________________________________________________________________________________________________

Page 3 of 16 

### 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

expre ssed 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 banan as 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 (U SDA) 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 asses sment 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 0.0 01 5 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 field

trial 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, resi dues in fish were not

included in the assessment.Thiram Dietary Exposure and Risk Assessment DP # 412466

____________________________________________________________________________________________________________________

Page 4 of 16 

### Processing Factors

Processing factors were obtained from strawberry washing and apple processing studies submitted to the Agency by the registrant (F. Fort, D283996, 0 4/20/03 ). 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 t he apple FDA monitoring

data. P rocessing 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

Washi ng (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, 0 1/12/12 ) . For the chronic analysis, average pe rcent 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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Page 5 of 16 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

. Est imated

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 fruit

babyfood PB 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

Peac h 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 20Thiram Dietary Exposure and Risk Assessment DP # 412466

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Page 6 of 16 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

. Est imated

Max

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 = blended.

2 FT = field

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



### I II. Drinking Water Data

The current action will not affect the EDWCs, the refore, 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 co mparison 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 TM 

### 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 conduct ed using the 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 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

- coo ked; 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 consumptionThiram Dietary Exposure and Risk Assessment DP # 412466

____________________________________________________________________________________________________________________

Page 7 of 16 

### 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 th e 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 average daily consumption estimate for that food/food form to produce a residue intake estimate. The resulting residue i ntake 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 perce nt 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

m ultiplied 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

ris k 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.Thiram Dietary Exposure and Risk Assessment DP # 412466

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Page 8 of 16 Table 4 . Summary of Toxicological Doses and Endpo ints 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 ) 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 Acute RfD =

0.014 mg/kg/day

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

- Rat

LOAEL = 3.7 mg/kg/day bas ed 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 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 dog s 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 estimat ed 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. UF A = extrapolation from animal to human (intraspecies). UF H = potential variation in sensitivity among members of the human population (interspecies). FQPA SF = FQPA Safety Factor. PAD = population

adju sted 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 estima te 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

____________________________________________________________________________________________________________________

Page 9 of 16 

### 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 monit oring 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 wat er 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 TM 

### , acute dietary exposure at the 99.9 th 

### exposure percentile is estimated at 0.0 20104 mg/kg bw /day for the general U.S. population ( 3. 1 % of the aPAD) and 0.0 10887 mg/kg bw /day ( 78 % of the aPAD) for females 13

- 49 years old , the population subgroup with the h ighest 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) 95 th Percentile 99 th Percentile 99.9 th Percentile

Exposure (mg/kg/day) %

aPAD Exposure

(mg/kg/day) %

aPAD Exposure

(mg/kg/day) %

aPAD

General U.S. Population 0.6494 0.00 3 419 <1 0.00 7 029 1. 1 0.0 20104 3. 1

All Infants (<1 year old) 0.6494 0.0 100 16 1

. 5 0.01 6352 2. 5 0.0 40 956 6. 3

Children 1

- 2 years old 0.6494 0.0 08983 1. 4 0.0 2 4980 3.9 0.0 64254 9 .9

Children 3

- 5 years old 0.6494 0.00 5982 <1 0.0 14 708 2. 3 0.0 39745 6.1

Children 6

- 12 years old 0.6494 0.00 3733 <1 0.00 8783 1. 4 0.0 21715 3.3

Youth 13

- 19

years old 0.6494 0.002 718 <1 0.00 4989 <1 0.0 11129 1

. 7

Adults 20

- 49 years old 0.6494 0.00 3 017 <1 0.00 4806 <1 0.0 10891 1. 7

Adults 50

- 99 years old 0.6494 0.00 2807 <1 0.00 5 012 <1 0.0 1 1 093 1. 7

Females 13

- 49 years old 0.014 0.00 3 074 2 2 0.00 5 024 3 6 0.0 10887 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 genera l U.S. population and all population subgroups. Using the DEEM

- FCID software, dietary exposure is estimated at

0.00 1384 mg/kg bw /day for the general U.S. population ( 9.2 % of the cPAD) and 0.00 8369 mg/kg bw /day ( 5 6 % of the cPAD) fo r 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.Thiram Dietary Exposure and Risk Assessment DP # 412466

____________________________________________________________________________________________________________________

Page 10 of 16 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 1384 9.2

All Infants (<1 year old) 0.015 0.00 4443 30

Children 1

- 2 years old 0.015 0.00 8369 5 6

Children 3

- 5 years old 0.015 0.00 49 47 33

Children 6

- 12 years old 0.015 0.00 2172 15

Youth 13

- 19 years old 0.015 0.00 0 877 5.8

Adults 20

- 49 years old 0.015 0.000 716 4.8

Adults 50

- 99 years old 0.015 0.00 0 947 6.3

Females 13

- 49 years old 0.015 0.00 0 823 5.5 * The values for the highest expos ed 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, grow ers 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 n ot 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

Attachme nt 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 (RAB 4 )

T. Morton : S10 838 : PY

- S :(703)305

- 6691 :7509 P :RAB 4Thiram Dietary Exposure and Risk Assessment DP # 412466

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Page 11 of 16 

### 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 Str awberry 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, s auce

- 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 1 2B 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, ju ice 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 1 1.400000 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 1.000Thiram Dietary Exposure and Risk Assessment DP # 412466

____________________________________________________________________________________________________________________

Page 12 of 16 

### Attachment 2

- Results of Refined Acute Dietary Analysis for Th iram

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 P lus 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 summe d over 24 hours
MC iterations = 1000; MC list in residue file; MC seed = 10281; RNG = MS VB

Run Comment: ""

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

Summary calculations

-- per capita:

95th Percenti le 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 0.009 770 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 71.25Thiram Dietary Exposure and Risk Assessment DP # 412466

____________________________________________________________________________________________________________________

Page 13 of 16 

### 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 To lerance 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 fr uit

- 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 7.0000 00 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

12022 60000 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

- b abyfood 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 20.00 0000 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

860 1000000 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 comme nt: 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

9500024 001 O Banana, dried

- babyfood 0.800000 3.900 1.000Thiram Dietary Exposure and Risk Assessment DP # 412466

____________________________________________________________________________________________________________________

Page 14 of 16 

### Attachment 4

- Results of Partially Refined Chronic Dietary Analysis for Thiram

U.S. EPA Ver. 3.16, 03

- 08

- d

DEEM

- FCID Chronic ana lysis 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

____________________________________________________________________________________________________________________

Page 15 of 16 

### Attachment 5

- Quantitative Usage Analysis

Thiram (079801) Screening Level Usage Analysis (SLUA)

Date: January 12, 2012

What is a Screening Level Usage Analysis (SL UA)?

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 pr esented 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 pestici de 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 ar e 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 s ignificant 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 nea rest 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 a ll 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 Agr icultural Statistics Service)

– pesticide usage data from 200 3 to 20 10

. Private pesticide market research

– pesticide usage data from 200 3 to 20 10

. California Department of Pesticide Regulation (DPR) Pesticide Use Reporting (PUR) data for 200 3 to 200 9.

Wha t 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

____________________________________________________________________________________________________________________

Page 16 of 16 

### 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, da ta 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 6 0,000 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 5 0,000 2 0 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 Nati onal Agricultural Statistics Service)

Private Pest icide Market Research California DPR (Department of Pesticide Regulation)

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