### UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

MEMORANDUM


### DATE: June 19, 2013 WASHINGTON, D

.C

. 20460

OFFICE OF CHEMICAL SAFETY AND POLLUTION PREVENTION



### SUBJECT: 

### Tebuconazole: Clarification on Percent Crop Treated Values Used in Dietary Assessments. PC Code: 128997 Decision No.: 464543 Petition No.: 2E8012 Risk Assessment Type: Single ChemicaV Aggregate TXRNo.: NA MRIDNo.: NA 

### From: Barry O'Keefe, Biologist Christine Olinger, Chief DP Barcode: 412582 Registration No.: 264-752,264-748 Regulatory Action: Tolerance Petition CaseNo.: NA CAS No.: 107534-96-3 40 CFR: §180.474



### TO: Sidney Jackson/Barbara Madden, RM Team 05 Risk Integration, Minor Use and Emergency Response Branch Registration Division (7505P)
HED recently completed a human health risk assessment to support a crop group conversion (Fruiting Vegetables 8-10) as well as tolerance increases needed after submission ofcondition of registration data (B. O'Keefe, D402457, 1/31/13). Since minimal changes were needed for the dietary risk assessment, HED slightly modified an existing dietary risk assessment that relied upon percent crop treated (PCT) and percent crop treated -new (PCTn) estimates from 2006. The Registration Division has asked HED to compare the PCT values used in the assessment to the most recent estimates available (20 11) to ensure that dietary exposure is not underestimated. Note that the dietary assessment (DP408526, M. Negussie, 1129/13) is partially refined with percent crop treated estimates as well as monitoring data for a few crops, while tolerance values and field trial data were used for the remaining crops. A comparison ofthe PCT adjustments in the dietary risk assessment and the maximum and average PCT estimates from the most recent screening level usage analysis (SLUA) available (2011) are presented in Table 1
. The maximum estimates are used for acute dietary exposure assessments and the average values are used in chronic assessment. The PCT estimates for grapes, nectarines, peaches, and peanuts are based onthe 2006 SLUA, while the estimates for Page 1 of4

### apricots, apples, cherries, hops, plums and turnips are based on PCTn estima tes, since they were not registered at the time ofthe assessment. HED assumed 100% crop treated for the remaining commodities: almonds, asparagus, banana, barley, dry bean, snap bean, nuts, coffee, field com, beets, garlic, leeks, tropical fruits, pumpkin, sunflower, wheat, squash, soybean, fruiting vegetables, and livestock commodities. While there were a few crops with slight increases in PCT values (peanut and peach maxima; and grape average), HED believes that the overall exposure assessment is conservative and is likely to be an overestimate for the following reasons: i) 100% crop treated was assumed for several commodities including some with high 

### dietary consumption (e.g. soybeans, wheat), where the 2011 SLUA reflects a much lower usage ra te; and ii) PCTn values were used for several registered crops, and the 20 11 usage data indicates much lower relative usage. Furthermore, the attached critical commodity contribution analysis for children ages 1-2, the most highly exposed subgroup, demonstrates that the greatest contributors to the exposure are fruiting vegetables and drinking water. Table 1. Comparison ofPercent Crop treated (PCT) Estimates Used in the Tebuconazole Dietary Assessments Commodity Acute PCT Used Chronic PCT Used in 2011 SLUA 2011 SLUA in Assessment Assessment Maximum Average Commodities for Which PCT is based on 2006 SLUA Grapes 25 15 25 20 Nectarines 25 20 25 20 Peaches 20 15 25 15 Peanuts 45 35 50 35 Commodities for Which PCT is based on 2006 PCTn Apricots 56 43 20 

### 5 Apples 44 41 <2.5 <1 Cherries

- babyfood 42 37 45 35 Cherries

- all ot her 100 66 45 35 food forms Hops 64 64 5 N/C Plums 26 24 <5 <2.5 Sweet Com 22 14 NR NR Turnips 68 44 NR NR Commodities with Assumption of 100% CT and Included in 2011 SLUA Almond 100 100 <2.5 <1 Asparagus 100 100 10 

### 5 Barley 100 100 

### 5 5 Beans, Green 100 100 <2.5 <1 Soybeans 100 100 <2.5 <1 Wheat 100 100 

### 5 5 

### NR =No use reported

Page 2 of4

### Attachment. Critical Commodity Contribution Analysis for Children Ages 1

-2. US EPA Ver. 3
. 16, 03-08

- d DEEM-FCID Chronic ana l ysis for TEBUCONAZOLE NHANES 2003-2008 2-day Residue file name: C:\Documents and Settings\colinger\My Documents\$RAB3\Chemicals\Tebuconaz ole\Di e tary\TEBU CONAZOLEFOOD_WA TERCHRONIC20 13

_TOL

_BarleyCant WATER.R08 Adjustment factor #2 used. Anal ys i s Date 05-16-2013/20:24:2 1 Residue file dat ed: 01-17

- 2013/10:23:16 Refer ence dose (RfD, Chronic) = .029 mg/kg bw/day COMMENT 1: Food + H20 Additional data

- Barley and Cantal oupe and Crop G r oup Expansion to 8-10 Crit ical Commodity Contribution Anal ysis for Children 1

- 2 Total Exposure =.0042001 mg/kg bw/day Crop groups w ith total exposure contribution > 2% Foods/Foodforms with exposure contribution > 1% Crop group Food Foodform ----------Exposure Analysis-------- mg/kg % of Total Per cent body wt/day Exposure of RfD Crop G r oup 

### = (8) Frui t ing Vegetabl es Pepper, bell (0802270000): FoodForm N/S Tomato (0801375000) : FoodForm N/S Tomato, paste (0801376000): FoodForm N/S Tomato, pur ee (08013 77 000) : FoodForm N/S Tomat o, juice (0801379000 ) : FoodForm N /S Total for crop group Crop Group 

### = (SA) Tomato Tomato (0801375000) : FoodForm N/S Tomato, paste (0801376000): FoodForm N/S Tomato, puree (0801377000 ) : FoodForm N/S Tomato, juice (0801379000 ) : FoodForm N/S Total for crop group Crop Group = ( 8B) Bell Pepper Pepper, bell (0802270000): FoodForm N/S Total for crop group Crop Group = (15) Cereal Grains Oat, g r oats/rolled oats (1500233000) : FoodForm N/S Wheat, flour (1500402000): FoodForm N/S Total for crop group Crop Group = (86) Water Water, direct, al l sources (8601000000):0.0000494 0.0006466 0.0001165 0.0002837 0.0002507 0.00 1 38 1 2

0.0006466 0.0001165 0.0002837 0.0002507 0 .00 1 33 1 6

0.0000494 0 .0000495

0.0000832 0.0005587 0. 0007218

FoodForm N/S 0
. 0011464 Water, indirect, all sources (8602000000): FoodForm N/S 0.0006357 1.18% 0. 1 7% 1 5.39% 2
. 23%

2. 77 % 0
. 40% 6.76% 0.98% 5.97% 0.86% 32.88 % 4
. 76%

1 5
. 39% 2.23%

2. 77% 0.40% 6.76% 0.98% 5. 97% 0.86% 3 1.70% 4.59%

1.18% 0. 1 7% 1.18% 0.17%

1.98% 0.29% 13
. 30% 1.93% 17 .19% 2.49%

27.29% 3.95% 15.14% 2.19% Total for crop group 0.0017821 42.43% 6 .1 5% 

### Page 3 of4Crop group Food -- ------ -- Exposure Analysis

-------- mg/kg t of Total Percent Foodform body wt/day Exposure of RfD Crop Group 

### = (86A) Direct Water Water, direct, a ll sources ( 8601000000 ) : FoodForm N /S 0.0011464 27.29% 3.95t



## ---------- ---------- Total for crop group 0.0011464 27.29% 3.95% Crop Group = (86B) Indirect Water Water, indirect, all sources (860 2000000): FoodForm N/S 0.0006357 15.14% 2.19t



### ---------- ---------- Total for crop group 0
. 0006357 15.14% 2.19% Total for crop groups l isted abov e : 0. 003885 1 92.50% 13.4%



### Page 4 of4