### Page 1 of 6 UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, D.C. 20460 OFFICE OF CHEMICAL SAFETY AND POLLUTION PREVENTION 

### MEMORANDUM 

### Date: July 01 , 20 1 3 SUBJECT: **Mancozeb .**  Revised Acute, Chronic, and Cancer Dietary Risk Assessments f or 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:** D 412565 and D 412566 **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 T **XR No.:** Not Applicable **CAS No.:** 8018
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- 7, 9006
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- 2, and 96

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- 7 **MRID No.:** None **40 CFR:** § 180.17 6 & § 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 (750 5 P)
This memorandum serves to revise the acute, chronic, and cancer ag gregate 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.

### Page 2 of 6

In addition to the anal ys es 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, 04/08/201 3)

. The revision of these dietary anal ys es 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 2 5 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

anal ysis show s 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 revise d %CT estimates for the use of mancozeb on walnuts and tangerines were recently prov ided b y 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 assessment s overestimates exposure s and is protective. The results for the revised dietary risk anal ys es 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 Manco**  **zeb and ETU (Food Only). Population Subgroup**  **aPAD (m** **g/k g/day)**  **9 9.9**  **th Percentile**  **Previously Reported Results of**  **04/18/13 Revised Results**  **Exposure (m** **g/k g/day)**  **% aPAD Exposure**  **(m g/k**  **g/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 Manco**  **zeb and ETU (Food Only). Population Subgroup**  **aPAD (m** **g/k g/day)**  **9 9.9**  **th Percentile**  **Previously Reported Results of**  **04/18/13 Revised Results**  **Exposure (m** **g/k g/day)**  **% aPAD Exposure**  **(m g/k**  **g/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 *T he 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 (m** **g/k g/day)**  **Previously Reported** 

**Results of**  **04/08/13 Revised Results**  **Exposure (m** **g/k g/day)**  **% cPAD Exposure**  **(m g/k**  **g/day) % cPAD**  General U.S. Population 0. 16 0.000107 0.1 0.000109 0.1 All Infants (< 1 year old) 0.0 16 0.000086 0.5 0.000086 0.5 **Children 1 -**  **2 years old 0.0**  **16 0.000374**  **2.3 0.000375**  **2.3** Children 3

- 5 years old 0.0 16 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 0.0 16 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**

**(m g/k**  **g/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 (m** **g/k g/day)**  **% cPAD**  **Exposure**

**(m g/k**  **g/day) %** 

**cPAD Exposure** 

**(m g/k**  **g/day) %**  **cPAD Exposure** 

**(m g/k**  **g/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 subgroup s . Results of Cancer Dietary Exposure Anal ys is 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**  **(m g/k**  **g/day) Estimated** 

**Cancer Risk Exposure**  **(m g/k**  **g/day) Estimated** 

**Cancer Risk** General U.S. Population

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

– Food and Water 0.000030 1.8 x 10 - 6 0.000031 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.

### Page 5 of 6

**Table 6**  **. Results of Acute Dietary Exposure Analysis for ETU (Food Only & Food and Water).** 

**Population Subgroup aPAD**  **(m g/k**  **g/day) 9**  **9.9 th**  **Percentile Previously Reported Results**  **of 04/08/13 Revised Results**  **Exposure (m** **g/k g/day)**  **% aPAD Exposure**  **(m g/k**  **g/day) % aPAD**  Females 13

- 49 years old 0.005 0.001433 29 0.00 1479 30 Females 13

- 49 years old (Food and water) 0.005 0.002962 59 0.00 300 6 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**

**(m g/k**  **g/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**  **(m g/k**  **g/day) %**  **cPAD Exposure** 

**(m g/k**  **g/day) %** 

**cPAD Exposure** 

**(m g/k**  **g/day) %**  **cPAD Exposure** 

**(m g/k**  **g/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 subgroup s . Results of Cancer Dietary Exposure Anal ys is 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 fun gi cides are presented in Table 8
.

### Page 6 of 6

**Table 8**  **. Results of Cancer Dietary Exposure Analysis fo r ETU from Mancozeb** 

**Population Subgroup Previously Reported Results**  **of 04/08/13**  **Revised Results Exposure**  **(m g/k**  **g/day) Estimated** 

**Cancer Risk Exposure**  **(m g/k**  **g/day) Estimated** 

**Cancer Risk** General U.S. Population

– Food Only 0.000029 1.8x 10 - 6 0.000030 1.8x 10 - 6 General U.S. Population

– Food and Water 0.000034 2.0 x 10 - 6 0.000034 2.0 x 10 - 6