Document ID: EPA-HQ-OPP-2012-0628-0011
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2013-07-24T04:00Z

\* MERGEFORMAT
                 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.  
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)
                              99.9[th] 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
                                      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

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[-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.

Table 6.  Results of Acute Dietary Exposure Analysis for ETU (Food Only & Food and Water).
                              Population Subgroup
                                aPAD (mg/kg/day)
                              99.9[th] 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.  

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[-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]