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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, D.C. 20460

OFFICE OF CHEMICAL SAFETY 

AND POLLUTION PREVENTION

MEMORANDUM

Date: July 01, 2013

SUBJECT: Mancozeb. Revised Acute, Chronic, and Cancer Dietary Risk Assessments for Food and 

Drinking Water, as well as Aggregate Assessment for the Common Metabolite/Degradate 

ETU resulting from the combined uses of the EBDC Fungicides to Support the New Use of 

Mancozeb on Walnuts and the Establishment of a Tolerance on Imported Tangerines for 

Section 3 Registration. 

PC Code: 014504, 014601, and 600016 DP Barcode: D412565 and D412566

Decision No.: 457087 and 467111 Registration No.: Not Applicable

Petition No.: 1F7935 and 2E8062 Regulatory Action: Section 3 Registration

Risk Assessment Type: Not Applicable Case No.: 0643

TXR No.: Not Applicable CAS No.: 8018-01-7, 9006-42-2, and 96-45-7

MRID No.: None 40 CFR: §180.176 & §180.217

FROM: Peter Savoia, Chemist

Risk Assessment Branch V/VII

Health Effects Division (7509P)

THRU: Michael Metzger, Chief

Risk Assessment Branch V/VII

Health Effects Division (7509P)

TO: Danette, Drew, Risk Assessor

Risk Assessment Branch V/VII

Health Effects Division (7509P)

And

Heather Garvie, Risk Manager and

Tamue Gibson, Risk Manager

Fungicide Branch

And

Andrew Ertman, Biologist

Risk Integration, Minor Use and Emergency Response Branch

Registration Division (7505P)

This memorandum serves to revise the acute, chronic, and cancer aggregate dietary food and 

drinking water exposure and risk assessments to support the proposed Section 3 uses of mancozeb 

on walnuts and the establishment of a tolerance on imported tangerines (D402043 and D405277, P. 

Savoia, 04/08/2013). Mancozeb is in the class of ethylene bisdithiocarbamate fungicides (EBDCs), 

which all produce the common metabolite and environmental degradate, ethylene thiourea (ETU). 

The only other EBDC fungicide which is currently registered for use in the United States is metiram. 
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In addition to the analyses made for mancozeb, the dietary exposure and risk resulting from the 

consumption of ETU residues derived from mancozeb and from the established uses of metiram 

were also reassessed (D405592, P. Savoia, 04/08/2013).

The revision of these dietary analyses are made to incorporate the most current projected percent 

crop treated (%CT) estimates for almonds, broccoli, cabbage, lettuce, and peppers. These projected 

values are based on 2002-2008 data and are as follows:

Table 1. Updated Projected Percent Crop Treated Values reported in the BEAD September 16, 2010 

Memorandum.

Use Acute Chronic

Almond 25 18

Broccoli 6 5

Cabbage, fresh 47 42

Cabbage, processed (Chinese) 47 42

Lettuce, head 75 67

Lettuce, other (leaf) 66 62

Peppers, bell 48 44

Peppers, other 48 44

The revised dietary analysis shows very minimal change in exposure for mancozeb and for the 

exposure assessment of ETU resulting from the combined uses of the EBDC fungicides. Additional 

new revised %CT estimates for the use of mancozeb on walnuts and tangerines were recently

provided by BEAD to further refine this assessment but were not included in this revision. Because 

the revised %CT estimates for walnuts and tangerines are lower, these dietary assessments

overestimates exposures and is protective. The results for the revised dietary risk analyses are 

shown below. 

Results of Acute Dietary Exposure Analysis for Mancozeb

Acute assessments were conducted for mancozeb and ETU and are presented in Table 2. Results are 

reported at the 99.9th percentile of exposure because the assessment incorporated estimates of %CT.

Table 2. Results of Acute Dietary Risk Analysis for Mancozeb and ETU (Food Only).

Population Subgroup aPAD 

(mg/kg/day)

99.9th Percentile

Previously Reported Results

of 04/18/13 Revised Results

Exposure 

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

Mancozeb

General U.S. Population 5.0 0.014388 0.29 0.014415 0.29

All Infants (<1 year old) 0.5 0.011425 2.3 0.011425 2.3

Children 1-2 years old* 0.5 0.049471 9.9 0.049469 9.9

Children 3-5 years old 0.5 0.036223 7.2 0.035863 7.2

Children 6-12 years old 5.0 0.017499 0.35 0.017499 0.35

Youth 13-19 years old 5.0 0.009590 0.19 0.009591 0.19

Adults 20-49 years old 5.0 0.009912 0.2 0.009914 0.2

Adults 50-99 years old 5.0 0.008187 0.16 0.008235 0.16

Females 13-49 years old 0.13 0.011634 9.0 0.011640 9.0
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Table 2. Results of Acute Dietary Risk Analysis for Mancozeb and ETU (Food Only).

Population Subgroup aPAD 

(mg/kg/day)

99.9th Percentile

Previously Reported Results

of 04/18/13 Revised Results

Exposure 

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

ETU

Females 13-49 years old 0.005 0.001426 28 0.001414 28

Females 13-49 years old (Food and Water) 0.005 0.002901 58 0.002901 58

*The subpopulation with the highest risk estimates 

Results of Chronic Dietary Exposure Analysis for Mancozeb

Chronic assessments were conducted for mancozeb and ETU and are presented in Table 3 for 

mancozeb, and Table 4 for ETU.

Table 3. Results of Chronic Dietary Exposure Analysis for Mancozeb, Food Only

Population Subgroup cPAD

(mg/kg/day)

Previously Reported 

Results of 04/08/13 Revised Results

Exposure 

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

General U.S. Population 0.16 0.000107 0.1 0.000109 0.1

All Infants (< 1 year old) 0.016 0.000086 0.5 0.000086 0.5

Children 1-2 years old 0.016 0.000374 2.3 0.000375 2.3

Children 3-5 years old 0.016 0.000260 1.6 0.000262 1.6

Children 6-12 years old 0.16 0.000119 0.1 0.000120 0.1

Youth 13-19 years old 0.16 0.000064 0.0 0.000066 0.0

Adults 20-49 years old 0.16 0.000090 0.1 0.000092 0.1

Adults 50-99 years old 0.16 0.000097 0.1 0.000100 0.1

Females 13-49 years old 0.016 0.000101 0.6 0.000103 0.6
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Table 4. Results of Chronic Dietary Exposure Analysis for ETU from Mancozeb

Population 

Subgroup

cPAD

(mg/kg/day)

ETU – Food Only ETU – Food and Water

Previously 

Reported Results

of 04/08/13

Revised Results

Previously 

Reported Results

of 04/08/13

Revised Results

Exposure 

(mg/kg/day)

% 

cPAD

Exposure 

(mg/kg/day)

% 

cPAD

Exposure 

(mg/kg/day)

% 

cPAD

Exposure 

(mg/kg/day)

% 

cPAD

General U.S. 

Population 0.0018 0.000026 1.4 0.000026 1.5 0.000030 1.7 0.000031 1.7

All Infants (< 

1 year old) 0.00018 0.000034 19 0.000034 19 0.000045 25 0.000045 25

Children 1-2 

years old 0.00018 0.000086 48 0.000086 48 0.000092 51 0.000092 51

Children 3-5 

years old 0.00018 0.000057 32 0.000057 32 0.000062 35 0.000062 35

Children 6-12 

years old 0.0018 0.000029 1.6 0.000029 1.6 0.000033 1.8 0.000033 1.8

Youth 13-19 

years old 0.0018 0.000018 1.0 0.000019 1.0 0.000022 1.2 0.000022 1.2

Adults 20-49 

years old 0.0018 0.000023 1.3 0.000023 1.3 0.000027 1.5 0.000027 1.5

Adults 50-99

years old 0.0018 0.000022 1.2 0.000022 1.2 0.000026 1.5 0.000027 1.5

Females 13-

49 years old 0.00018 0.000023 13 0.000024 13 0.000028 15 0.000028 16

** The values for the highest exposed population for each type of risk assessment are bolded.

The results indicate that dietary risk estimates for mancozeb and ETU are not of concern for all

population subgroups.

Results of Cancer Dietary Exposure Analysis for Mancozeb

Exposure and risk estimates for the ETU cancer assessment are presented in Table 5. 

Table 5. Results of Cancer Dietary Exposure Analysis for ETU from Mancozeb

Population Subgroup

Previously Reported Results of 

04/08/13 Revised Results

Exposure

(mg/kg/day)

Estimated 

Cancer Risk

Exposure

(mg/kg/day)

Estimated 

Cancer Risk

General U.S. Population – Food Only 0.000026 1.6 x 10-60.000026 1.6 x 10-6

General U.S. Population – Food and Water 0.000030 1.8 x 10-60.000031 1.8 x 10-6

Results of Acute Dietary Exposure Analysis for ETU From the Combined EBDC Fungicides

The acute aggregate assessments conducted for the ETU metabolite resulting from the combined 

uses of the EBDC fungicides are presented in Table 6. Results are reported at the 99.9th percentile 

of exposure because the assessment incorporated estimates of %CT.
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Table 6. Results of Acute Dietary Exposure Analysis for ETU (Food Only & Food and Water).

Population Subgroup aPAD 

(mg/kg/day)

99.9th Percentile

Previously Reported Results

of 04/08/13 Revised Results

Exposure 

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

Females 13-49 years old 0.005 0.001433 29 0.001479 30

Females 13-49 years old (Food and water) 0.005 0.002962 59 0.003006 60

Results of Chronic Dietary Exposure Analysis for ETU from the Combined EBDC Fungicides

The chronic aggregate assessments conducted for the ETU metabolite resulting from the combined 

uses of the EBDC fungicides are presented in Table 7.

Table 7. Results of Chronic Dietary Exposure Analysis for ETU (Food Only & Food and Water).

Population 

Subgroup

cPAD

(mg/kg/day)

ETU – Food Only ETU – Food and Water

Previously 

Reported Results

of 04/08/13

Revised Results

Previously 

Reported Results

of 04/08/13

Revised Results

Exposure 

(mg/kg/day)

% 

cPAD

Exposure 

(mg/kg/day)

% 

cPAD

Exposure 

(mg/kg/day)

% 

cPAD

Exposure 

(mg/kg/day) % cPAD

General U.S. 

Population 0.0018 0.000029 1.6 0.000030 1.7 0.000034 1.9 0.000034 1.9

All Infants (< 

1 year old) 0.00018 0.000040 22 0.000040 22 0.000051 28 0.000051 28

Children 1-2 

years old 0.00018 0.000098 54 0.000097 54 0.000104 58 0.000104 58

Children 3-5 

years old 0.00018 0.000063 35 0.000063 35 0.000069 38 0.000069 38

Children 6-12 

years old 0.0018 0.000032 1.8 0.000032 1.8 0.000036 2.0 0.000036 2.0

Youth 13-19 

years old 0.0018 0.000020 1.1 0.000020 1.1 0.000023 1.3 0.000023 1.3

Adults 20-49 

years old 0.0018 0.000026 1.4 0.000026 1.5 0.000030 1.7 0.000031 1.7

Adults 50-99

years old 0.0018 0.000026 1.4 0.000026 1.4 0.000030 1.7 0.000030 1.7

Females 13-

49 years old 0.00018 0.000027 15 0.000027 14.9 0.000031 17 0.000031 17

** The values for the highest exposed population for each type of risk assessment are bolded.

The results indicate that aggregate dietary risk estimates for the ETU metabolite are not of concern 

for all population subgroups.

Results of Cancer Dietary Exposure Analysis for ETU From the Combined EBDC Fungicides

Exposure and risk estimates for the aggregate ETU cancer assessment resulting from the combined 

uses of the EBDC fungicides are presented in Table 8. 
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Table 8. Results of Cancer Dietary Exposure Analysis for ETU from Mancozeb

Population Subgroup

Previously Reported Results of 

04/08/13 Revised Results

Exposure

(mg/kg/day)

Estimated 

Cancer Risk

Exposure

(mg/kg/day)

Estimated 

Cancer Risk

General U.S. Population – Food Only 0.000029 1.8x 10-60.000030 1.8x 10-6

General U.S. Population – Food and Water 0.000034 2.0 x 10-60.000034 2.0 x 10-6