Trinexapac

- ethyl Dietar y Exposure Assessment DP Barcode: 394830



### Page 1 of 12 UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, D.C. 20460

OFFICE OF CHEMICAL SAFETY AND

POLLUTION PREVENTION



### MEMORANDUM

D ATE : September 13, 2011

SUBJECT: Trinexapac

- ethyl : Acute and Chronic Dietary Exposure and Risk

Assessment for the Proposed Uses on Cereal Grains, Sugarcane

and Grasses Grown for Seed

.

PC Code: 112602 DP Barcode: D 394830

Decision No.: 432768 and

433096 Registration No. : 100

- 727 , 100

- 949, and 100

- 1241
Petition No.: 0F7719 and

0F7720 Regulatory Action: Section 3

First Food Use R egistration Risk Assessment Type: Dietary Case No.: NA

T XR No.: NA CAS No.: 95266

- 40

- 3

MRID No.: NA 40 CFR: NA



### FROM: Sheila Piper, Chemist

Risk Assessment Branch VI Health Effects Division (7509P)

THROUGH: Douglas Dotson, Ph.D., Chemist

Julie Van Alstine, MPH, Environmental Health Scientist Dietary Exposure SAC (7509P)

and Felecia Fort, Branch Chief

Risk Assessment Branch VI Health Effects Division (7509P)

TO: Bethany Benbow, Risk Manager Reviewer

Kathryn Montague, Risk Manager

Herbicide Branch Registration Division (7505P)Trinexapac

- ethyl Dietar y Exposure Assessment DP Barcode: 394830



### Page 2 of 12 Executive Summary

At the request of the Registration Division, a n a cute and chronic dietary risk assessment

for trinexapac

- ethyl was conducted using the Dietary Exposure Evaluation Model (DEEM

- FCID TM , Version 2.03)

. The analyses were performed to support petition s (PP#0F7719 and 0F7720 ) for the establishment of tolerances includ ing free and conjugated residues of both the parent and its acid metabolite, trinexapac

. Th ese analyses

w ere performed to estimate acute and chronic dietary (food and drinking water) risk resulting from use of trinexapac

- ethyl on cereal grains, sugarcane, and grasses grown for

seed

.

Acute Dietary ( Food and Drink ing Water) Exposure Results and Characterization

An unrefined, acute dietary exposure assessment using the recommended tolerance level s and assuming 100% crop treated (CT) for the proposed commodities was conducted for the general U.S. population and vario us population subgroups. The estimated drinking water concentration (EDWC) of trinexapac

- ethyl was provided by the Environmental Fate and Effects Division (EFED) and incorporated directly into the acute assessment. The drinking

water estimate w as based on the use of trinexapac

- ethyl on sugarcane in LA. The acute drinking water concentration in surface water is 10.92 ppb.

For food and drinking water

, the acute dietary risk estimate is below HED’s level of

concern ( <100% of the acute population adjusted dose (aPAD) ) at the 9 5 th 

### percentile of

exposure. The acute dietary exposure was estimated for females 13

- 49 years old only

, since an acute endpoint of concern was not identified for the general U.S. population

. The acute dietary exposure estimate for fem ales 13

- 49 years old is 0. 014310 mg/kg/day ( 2 % of the aPAD).

Chronic Dietary (Food and Drinking Water) Exposure Results and Characterization

The chronic dietary exposure and risk estimates are conservative since they assume that 100% of crops are trea ted and that the residues are present at the recommended tolerance

level s . T he chronic surface water E DW C for trinexapac

- ethyl is 0.98 ppb. C ombined chronic dietary exposure estimates for food and drinking water are well below HED’s level

of concern. Usi ng the DEEM

- FCID software, dietary exposure is estimated at

0. 00 7871 mg /kg/day for the general U.S. population , which is equivalent to 2 .5 % of the chronic Population Adjusted Dose (cPAD)

, and 0. 0 19478 mg/kg/day , equivalent to 6 % of

the cPAD for children 1

- 2 years old , the population subgroup with the highest estimated chronic dietary exposure to trinexapac

- ethyl

.

Cancer Dietary (Food and Drinking Water) Exposure Results and Characterization

Trinexapac

- ethyl is classified as a “ n ot likely to be carcinogenic to human s

. ” Therefore,

a cancer dietary exposure analysis is not required

.Trinexapac

- ethyl Dietar y Exposure Assessment DP Barcode: 394830



### Page 3 of 12 I. Introduction

Dietary risk assessment incorporates both exposure and toxicity of a given pesticide. For acute and chronic assessments, the risk is expressed as a percentage of a maximum acceptable dose. This is the population adjusted dose (PAD), which HED has conclud ed

will result in no unreasonable adverse health effects. The PAD is the Reference Dose (RfD) divided by the FQPA Safety Factor. Dietary risk is expressed as a percentage of

the PAD. For acute and non

- cancer chronic exposures, HED is concerned when

esti mated dietary risk exceeds 100% of the PAD. References which discuss the acute and chronic risk assessments in more detail are available on the EPA/pesticides web site: “Available Information on Assessing Exposure from Pesticides, A User’s Guide”,

6/21/2 000, web link: http://www.epa.gov/fedrgstr/EPA

- PEST/2000/July/Day

- 12/6061.pdf ; or see SOP 99.6 (8/20/99).

Th is is the first dietary assessment c onducted for trinexapac

- ethyl

.

II. Residue Information

Trinexapac

- ethyl is a new unclassified plant growth regulator being proposed by Syngenta Crop Protection for use on grasses grown for seed , cereal grain and sugarcane throughout the U.S. Trinexapac

- ethyl inhibits internodal elongation and growth in cereal grains, grasses and several dicotyledonous species. It is registered in numerous European

countries and several Asian and Latin American countries for use on cereal grains and sugarcane. In the U.S., trinexapac

- ethyl ( 1 and 2 lb/gal EC formulations ) are currently regis tered for use on perennial ryegrass grown for seed in Idaho, Oregon and Washington. No tolerances have been established for trinexapac

- ethyl residues on any

food or feed commodities.

The nature of trinexapac

- ethyl residues in grass, cereal grain, and s ugarcane commodities

and ruminants is understood based on the available grass, rice, poultry and goat

metabolism studies

. The residues of concern in plants and livestock for tolerance

enforcement and risk assessment purposes include free and conjugated re sidues of both parent and its acid metabolite, trinexapac ( Residues of Concern Knowledgebase Subcommittee (ROCKS), D390121, 7/ 12 /11)

.

The proposed use directions would allow for a single or split application of trinexapac

ethyl to grasses grown for seed d uring stem elongation and floral development, at a

maximum rate of 0.5 lb ai/A

, a 35

- day preharvest interval (PHI) for ma ture grass, and a

49

- day PHI for regrowth of forage and hay following harvest. Syngenta has also proposed label amendments and tolerances for the use of the 1 and 2 lb/gal EC products

to include cereal grains ( barley, oats, triticale, and wheat ) and sugarcane . A maximum

seasonal rate of 0. 11 lb ai/A and a 4 5

- day PHI for cereal gra ins and a maximum seasonal

rate of 0. 31 lb ai/A and a 28

- day PHI for sugarcane are proposedTrinexapac

- ethyl Dietar y Exposure Assessment DP Barcode: 394830



### Page 4 of 12 Table 1: Tolerance Summary for Trinexapac

- ethyl.
Commodity Recommended Tolerance (ppm) Comments

Cattle, fat 0.02

Cattle, meat 0.02

Cattle, meat byproducts 0.04 Based on highest residue in cattle kidney
Cattle, kidney Not needed Based on the recommended tolerance for “cattle, meat byproducts” an individual tolerance for kidney is not
needed.

Goat, fat 0.02

Goat, meat 0.02

Goat, meat byproducts 0.04 Based on highest residue in cattle kidney
Hog, fat 0.02

Hog, meat 0.02
Hog, meat byproducts 0.03

Horse, fat 0.02

Horse, meat 0.02
Horse, meat byproducts 0.04 Based on highest residue in cattle kidney
Sheep, fat 0.02
Sheep, meat 0.02
Sheep, meat byproducts 0.04 Based on highest residue in cattle kidney
Barley, grain 2.0 Data translated from wheat grain
Barley bran 2.5
Oat, grain 4.0 Data translated from wheat grain

Sugarcane, cane 0.8
Sugarcane, molasses 2.5

Wheat, grain 4.0

Wheat bran 6.0
Wheat middling 10.5



### III. Drinking Water Data

Reference s : Tier II Drinking Water Assessment for the First Food Use Registration of Trinexapac

- Ethyl on Cereals (Wheat, Barley, Oats) and Sugarcane ; D377936 ; Christopher Koper ; 0 9 / 09 /201 1

.Trinexapac

- ethyl Dietar y Exposure Assessment DP Barcode: 394830



### Page 5 of 12 A Tier II screening

- level drinking water assessment was conducted to support the human health risk assessment for the proposed first food use registration for trinexapac

- ethyl. Modeled application rates represent the maximum applicatio n rates from the proposed labels (Palisade® EC, EPA Reg. No. 100

- 949 and Palisade® 2EC EPA Reg. No. 100

- 1241) for use on cereals (wheat, barley, and oats) and sugarcane. For cereals, the proposed maximum application rate is 0.11 lbs. a.i./acre (1 applicat ion at 0.11 lbs. a.i./acre). For sugarcane, the proposed maximum application rate is 0.31 lbs. a.i./acre (1 application at 0.31 lbs. a.i./acre). Both of these commodities have split applications; however, neither crop exceeds the proposed maximum applica tion rates listed above. In addition, aerial and ground foliar spray applications and chemigation techniques are the proposed application methods.

Based on the ROCKS memorandum (D390121 , 7/12/11) , the parent ester including its

free acid CGA

- 17950 0, CGA

- 313458, an open chain cyclohexane ring and an unidentified hydroproduct M3 should be included in a Total Toxic Residue (TTR) approach for the drinking water assessment.

Water residues were incorporated in the DEEM

- FCID into the food categories “water, direct, all sources” and “water, indirect, all sources.” The groundwater value was generated using the Screening Concentration in Groundwater (SCI

- GROW) Model and the surface water values were generated using a Tier 2 sugarcane model. The surfac e water estimates were used for the acute (10.92 ppb) and chronic (0.98 ppb) assessments because this value was higher than the groundwater value. Table 2 provides a summary
of the Tier 2 modeled drinking water concentrations. The model and its descriptio n are available at the EPA internet site: http://www.epa.gov/oppefed1/models/water/

.

Table 2. Recommended Estimated Drinking Water Concentrations (EDWCs) 1 for Surface Water
and Ground Water

.
Drinking

Water
Source Model

Scenario Method 2 Maximum Application Rate (interval between applications) 1

- in

- 10

year
acute
( 

### μg/L ) 1

- in

- 10

year chronic
( 

### μg/L ) 30

- year

average ( 

### μg/L )

Surface

Water PRZM/EXAMS

LA Sugarcane ( December 03

– foliar) A 1 app @ 0.31 lb a.i./acre 10.92 0.98 0.59

Ground

Water SCI

- GROW

Sugarcane -- 1 app @ 0.31 lb a.i./acre 0.001 0.001 0.001

1 For surface water (PRZM/EXAMS), EDWC values adjusted with a Percent Cropped Area (PCA) factor of 0.87. For ground water (SCI

- GROW), no PCA adjustment was utilized.

2 A = aerial application

Bolded values were used in the dietary exposure assessment.



### IV

. DEEM

- FCID  Program and Consumption Information

Trinexapac

- ethyl acute dietary exposure assessments were conducted using the Dietary Exposure Evaluation Model software with the Food Commodity Intake DatabaseTrinexapac

- ethyl Dietar y Exposure Assessment DP Barcode: 394830



### Page 6 of 12 (DEEM

- FCID  , Version 2. 03 ), which incorporates consumption data from USDA’s Continuing Surveys of Food Intakes by Individuals (CSFII), 1994

- 1996 and 1998. The

1994

- 96, 98 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

- cooked; fresh or N/S, baked) using publicly available recipe translation files developed jointly by USDA/ARS and EPA. Consumption data are averaged for the entire U.S. population and within population subgroups for chronic exposure assessment, but are retained as individual consumption events for acute exposure assessment.

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 multiplied 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 v alues and then summed in a probabilistic (Tier 3/4) assessment. The resulting distribution of exposures is expressed as a percentage of the aPAD on both a user (i.e., 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

, significant differences in user vs. per capita exposure and ri sk

are identified and noted in the risk assessment.

V. Toxicological Information

On September 30

, 2011 , HED’s ToxSAC met to consider the endpoints of toxicological concern for acute and chronic dietary exposure as well as for occupational and residential exposure pursuant to the Food Quality Protection Act (FQPA) of 1996. No acute dietary toxicity endpoints were identi fied for the general population, and the route and duration of exposure are appropriate for only females 13

- 49 years old. Trinexapac

- ethyl is classified as “Not likely to be carcinogenic to humans

, ” and therefore, quantification of

cancer risk is not neces sary. Table 3 provides a summary of the toxicological doses and endpoints for trinexapac

- ethyl for use in the dietary exposure assessment.

Table 3 . Summary of Toxicological Doses and Endpoints for Trinexapac

- ethyl for use in Human Health
Risk Assessments

. 

### Exposure/
Scenario Point of

Departure Uncertainty/

FQPA Safety
Factors RfD, PAD, Level

of Concern for
Risk Assessment Study and Toxicological

Effects

Acute Dietary (General Population, including

Infants and Children) No appropriate endpoint for the general population including infants and childrenTrinexapac

- ethyl Dietar y Exposure Assessment DP Barcode: 394830



### Page 7 of 12 Table 3 . Summary of Toxicological Doses and Endpoints for Trinexapac

- ethyl for use in Human Health
Risk Assessments

. 

### Exposure/

Scenario Point of

Departure Uncertainty/

FQPA Safety

Factors RfD, PAD, Level

of Concern for
Risk Assessment Study and Toxicological

Effects

Acute Dietary (Females 13

- 49 years of age) NOAEL = 60

mg/kg UF A = 10x

UF H = 10x FQPA SF= 1x Acute RfD = 0.6

mg/kg

aPAD = 0.6 mg/kg Developmental rabbit study

MRID 41869524

LOAEL = 360 mg/kg, based

on a decrease in mean number

of fetuses/litter and an increase in post

- implantation loss

Chronic Dietary (All Populations) NOAEL= 31.6

mg/kg/day UF A = 10x

UF H = 10x FQPA SF= 1x Chronic RfD =

0.32 mg/kg/day

cPAD = 0.32 mg/kg/day C

hronic oral toxicity study

– dog

MRID 42779402/ 42779401

LOAEL = 357 mg/kg/day,

based on elevated serum cholesterol values in females,

mucoid feces in females and bloody feces in both sexes, and minimal, focal vacuolation of the dorsal medial hippocampus

and/or lateral midbrain in both

sexes Cancer (oral, dermal, inhalation) Classification: “Not likely to be Carcinogenic to Humans”

Point of Departure (POD) = A data point or an estimated point that is derived from observed dose

response data and used to mark the beginning of extrapolation to determine risk associated with

l ower 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 (interspecies). UF H = potential variation in sensi tivity among members of the human population (intraspecies). FQPA SF = FQPA Safety Factor. PAD = population adjusted dose (a = acute, c = chronic). RfD = reference dose.



### V I

. Results/Discussion

As stated above, for dietary assessments, HED is concerned when dietary risk estimates

exceed 100% of the PAD. The DEEM

- FCID  analyses estimate the dietary exposure of the U.S. population and 26 population subgroups. T he results are reported in Table 4 for the general U.S. Population, all infants (<1 y ear old), children 1

- 2, children 3

- 5, children

6

- 12, youth 13

- 19, females 13

- 49, adults 20

- 49, and adults 50+ years.

For food and drinking water, the acute dietary risk estimate i s below HED’s level of

concern at the 95 th 

### percentile of exposure. The acute dietary exposure was estimated for

females 13

- 49 years old only since an acute endpoint of concern was not identified for the general U.S. population

. The acute dietary exposure estimate for females 13

- 49 years old is 0

. 014310 mg/kg/day (2% of the aPAD).

C hronic dietary risk estimates for food and drinking water are well below HED’s level of

concern. Using the DEEM

- FCID software, dietary exposure is estimated at 0. 00 7871Trinexapac

- ethyl Dietar y Exposure Assessment DP Barcode: 394830



### Page 8 of 12 mg /kg/day for the general U.S. population eq uivalent to 2 .5 % of the cPAD and 0. 0 19478 mg/kg/day , equivalent to 6 % of the cPAD for children 1

- 2 years old, the population subgroup with the highest estimated chronic dietary exposure to trinexapac

- ethyl.

Table 4 . Summary of Dietary (Food Only) Exposure and Risk for Trinexapac

- ethyl

Population Subgroup Acute Dietary 1

(95 th % Percentile) Chronic Dietary Cancer 2

Dietary Exposure (mg/kg/day) %

aPAD Dietary

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

General U.S. Population 0.00 787 1 2.5

N/A N/A All Infants (< 1 year old) 0.00 5464 2

Children 1

- 2 years old 0.0 194 78 6

Children 3

- 5 years old 0.0 1927 2 6

Children 6

- 12 years old 0.0 1319 0 4

Youth 13

- 19 years old 0.0 0764 6 2

Adults 20

- 49 years old 0.0 06272 2

Adults 50+ years old 0.00 522 4 2

Females 13

- 49 years

old 1 0. 01431 0 2 0.00 588 4 2

1 aPAD=0.6 mg/kg/day for females 13

- 49 only (no appropriate endpoint for general US population including infants and children) cPAD=0.32 mg/kg/day

2 Not likely to be Carcinogenic to Humans



### VI I

. Discussion of Uncertainties

HED considers the acute and chronic assessment s to be very conservative. The

assessment s are based on recommended tolerance level residues for all commodities. In addition, it is assumed that 100% of all crops are treated. Further refinement to the analy se s could be made through the use of anticipated residues, incorporation of percentages of crops treated with trinexapac ethyl , and/or monitoring data that better

reflect residues at the ti me of consumption. Since risk estimates are well below HED ’s level of concern, a more highly refined analysis is not needed at this time.Trinexapac

- ethyl Dietar y Exposure Assessment DP Barcode: 394830



### Page 9 of 12 VIII. Conclusions

This highly conservative, unrefined analysis demonstrates that the requested uses for trinexapac ethyl will not result in acute and chronic dietary risk estimates that exceed

HED ’s level of concern for any of the regulated population subgroups, including those comprised of infants and children. The acute dietary exposure was estimated for females

13

- 49 years old only (2% of the aPAD) since an acute endpoint of concern was not identified for the general U.S. population

. The chronic dietary exposure estimate for the general U.S. population is 2 .5 % of the cPAD and 6 % of the cPAD for children 1

- 2 years old

.

IX

. Appendix: List of Attachments

· Attachment 1: Trinexapac

- ethyl Acute Residue Input File

- Food + Water

· Attachment 2: Trinexapac

- ethyl Acute Result File

- Food + Water

· Attachment 3: Trinexapac

- ethyl Chronic Residue Input File

- Food + Water

· Attachment 4: Trinexapac

- ethyl Chronic Result File

- Food + Water

CC: S.Piper S.Piper: S

- 10216 : Potomac Yard1 (PYI): 703

- 308

- 2717: 7509P: RABVI



### Attachment 1: Trinexapac

- ethyl Acute Residue Input File

- Food + Water

U.S. Environmental Protection Agency Ver. 2.02

DEEM

- FCID Acute analysis for TRINEXAPAC

- ETHYL

Residue file name: C: \ Deemfcid \ Trinexapac \ Trinexapac.R98 Analysis Date 09

- 22

- 2011 Residue file dated: 09

- 21

- 2011/15:10:23/8 Reference dose: aRfD = 0.6 mg/kg bw/day NOEL = 6 mg/kg bw/day Comment: food + drinking water

-------------------------------------------------------------------------------- EPA Crop Def Res Adj.Factors Comment Code Grp Food Name (ppm) #1 #2

-------- ---- ------------------------------- ---------- ------ ------ ------- 15000250 15 Barley, pearled barley 2.000000 1.000 1.000 15000251 15 Barley, pearle d barley

- babyfood 2.000000 1.000 1.000 15000260 15 Barley, flour 2.000000 1.000 1.000 15000261 15 Barley, flour

- babyfood 2.000000 1.000 1.000 15000270 15 Barley, bran 2.500000 1.000 1.000 21000440 M Beef, meat 0.020000 1.000 1.000 21000441 M Beef, meat

- babyfood 0.020000 1.000 1.000 21000450 M Beef, meat, dried 0.020000 1.920 1.000 21000460 M Beef, meat bypr oducts 0.040000 1.000 1.000 21000461 M Beef, meat byproducts

- babyfood 0.040000 1.000 1.000 21000470 M Beef, fat 0.020000 1.000 1.000 21000471 M Beef,fat

- babyfood 0.020000 1.000 1.000 21000480 M Beef, kidney 0.040000 1.000 1.000 21000490 M Beef, liver 0.040000 1.000 1.000 21000491 M Beef, liver

- babyfood 0.040000 1.000 1.000 23001690 M Goat, meat 0.020000 1.000 1.000 23001700 M Goat, meat byproducts 0.040000 1.000 1.000Trinexapac

- ethyl Dietar y Exposure Assessment DP Barcode: 394830



### Page 10 of 12 23001710 M Goat, fat 0.020000 1.000 1.000 23001720 M Goat, kidney 0.040000 1.000 1.000 23001730 M Goat, liver 0.040000 1.000 1.000 24001890 M Horse, meat 0.020000 1.000 1.000 15002310 15 Oat, bran 6.100000 1.000 1.000 15002320 15 Oat, flour 4.000000 1.000 1.000 15002321 15 Oat, flour

- babyfood 4.000000 1.000 1.000 15002330 15 Oat, groats/rolled oats 4.000000 1.000 1.000 15002331 15 Oat, groats/rolled oats

- babyfood 4.000000 1.000 1.000 25002900 M Pork, meat 0.020000 1.000 1.000 25002901 M Pork, meat

- babyfood 0.020000 1.000 1.000 25002910 M Pork, skin 0.030000 1.000 1.000 25002920 M Pork, meat byproducts 0.030000 1.000 1.000 25002921 M Pork, meat byproducts

- babyfood 0.030000 1.000 1.000 25002930 M Pork, fat 0.020000 1.000 1.000 25002931 M Pork, fat

- babyfood 0.020000 1. 000 1.000 25002940 M Pork, kidney 0.030000 1.000 1.000 25002950 M Pork, liver 0.030000 1.000 1.000 26003390 M Sheep, meat 0.020000 1.000 1.000 26003391 M Sheep, meat

- babyfood 0.020000 1.000 1.000 26003400 M Sheep, meat byproducts 0.040000 1.000 1.000 26003410 M Sheep, fat 0.020000 1.000 1.000 26003411 M Sheep, fat

- babyfood 0.020000 1.0 00 1.000 26003420 M Sheep, kidney 0.040000 1.000 1.000 26003430 M Sheep, liver 0.040000 1.000 1.000 95003620 O Sugarcane, sugar 0.800000 1.000 1.000 95003621 O Sugarcane, su gar

- babyfood 0.800000 1.000 1.000 95003630 O Sugarcane, molasses 2.500000 1.000 1.000 95003631 O Sugarcane, molasses

- babyfood 2.500000 1.000 1.000 15003810 15 Triticale, flour 4.000000 1.00 0 1.000 15003811 15 Triticale, flour

- babyfood 4.000000 1.000 1.000 86010000 O Water, direct, all sources 0.010920 1.000 1.000 86020000 O Water, indirect, all sources 0.010920 1.000 1.000 15004010 15 Wheat, grain 4.000000 1.000 1.000 15004011 15 Wheat, grain

- babyfood 4.000000 1.000 1.000 15004020 15 Wheat, flour 4.000000 1.000 1.000 15004021 15 Wheat, flour

- babyfood 4.000000 1.000 1.000 15004030 15 Wheat, germ 4.000000 1.000 1.000 15004040 15 Wheat, bran 6.000000 1.000 1.000



### Attachment 2: Trinexapac

- ethyl Acute Result File

- Food + Water

U.S. Environmental Protection Agency Ver. 2.02

DEEM

- FCID ACUTE Analysis for TRINEXAPAC

- ETHYL (1994

- 98 data) Residue file: Trinexapac.R98 Adjustment factor #2 NOT used. Analysis Date: 09

- 22

- 2011/14:16:30 Residue file dated: 09

- 21

- 2011/15:10:23/8 NOEL (Acute) = 6.000000 mg/kg body

- wt/day Daily totals for food and foodform consumption used. Run Comment: "food + drinking water"

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

Summary calc ulations (per capita):

95th Percentile 99th Percentile 99.9th Percentile Exposure % aRfD MOE Exposure % aRfD MOE Exposure % aRfD MOE

---------- ------- -------- ---------- ------- -------- ---------- ------- -------- Females 13

- 49 yrs:

0.014310 2.38 419 0.019946 3.32 300 0.028086 4.68 213



### Attachment 3: Trinexapac

- ethyl Chronic Residue Input File

- Food + Water

U.S. Environmental Protection Agency Ver. 2.00

DEEM

- FCID Chronic analysis for TRINEXAPAC

- ETHYL 1994

- 98 data

Residue file: C: \ Deemfcid \ Trinexapac \ Trinexapac_chronic.R98Adjust. #2 NOT usedTrinexapac

- ethyl Dietar y Exposure Assessment DP Barcode: 394830



### Page 11 of 12 Analysis Date 09

- 22

- 2011 Residue file dated: 09

- 22

- 2011/14:20:38/8 Reference dose (RfD) = 0.32 mg/kg bw/day Comment:food + drinking water

-------------------------------------------------------------------------------- Food Crop Residue Adj.Factors Comment EPA Code Grp Fo od Name (ppm)
#1 #2

-------- ---- ------------------------------- ---------- ------ ------ ------- 15000250 15 Barley, pearled barley 2.000000 1.000 1.000 15000251 15 Barley, pearled barley

- babyfood 2.000000 1.000 1.000 15000260 15 Barley, flour 2.000000 1.000 1.000 15000261 15 Barley, flour

- babyfood 2.000000 1.0 00 1.000 15000270 15 Barley, bran 2.500000 1.000 1.000 21000440 M Beef, meat 0.020000 1.000 1.000 21000441 M Beef, meat

- babyfood 0.020000 1.000 1.000 21000450 M Beef, meat, dried 0.020000 1.920 1.000 21000460 M Beef, meat byproducts 0.040000 1.000 1.000 21000461 M Beef, meat byproducts

- babyfood 0.040000 1.000 1.000

21000470 M B eef, fat 0.020000 1.000 1.000 21000471 M Beef,fat

- babyfood 0.020000 1.000 1.000 21000480 M Beef, kidney 0.040000 1.000 1.000 21000490 M Beef, liver 0.040000 1.000 1.000 21000491 M Beef, liver

- babyfood 0.040000 1.000 1.000 23001690 M Goat, meat 0.020000 1.000 1.000 23001700 M Goat, meat byproducts 0.040000 1.000 1.000 23001710 M Goat, fat 0.020000 1.000 1.000 23001720 M Goat, kidney 0.040000 1.000 1.000 23001730 M Goat, liver 0.040000 1.0 00 1.000 24001890 M Horse, meat 0.020000 1.000 1.000 15002310 15 Oat, bran 6.100000 1.000 1.000 15002320 15 Oat, flour 4.000000 1.000 1.000 15002321 15 Oat, flour

- babyfood 4.000000 1.000 1.000 15002330 15 Oat, groats/rolled oats 4.000000 1.000 1.000 15002331 15 Oat, groats/rolled oats

- babyfood 4.000000 1.000 1.000

25002900 M P ork, meat 0.020000 1.000 1.000 25002901 M Pork, meat

- babyfood 0.020000 1.000 1.000 25002910 M Pork, skin 0.030000 1.000 1.000 25002920 M Pork, meat byprod ucts 0.030000 1.000 1.000 25002921 M Pork, meat byproducts

- babyfood 0.030000 1.000 1.000 25002930 M Pork, fat 0.020000 1.000 1.000 25002931 M Pork, fat

- babyfood 0.020000 1.000 1.000 25002940 M Pork, kidney 0.030000 1.000 1.000 25002950 M Pork, liver 0.030000 1.000 1.000 26003390 M Sheep, meat 0.020000 1.0 00 1.000 26003391 M Sheep, meat

- babyfood 0.020000 1.000 1.000 26003400 M Sheep, meat byproducts 0.040000 1.000 1.000 26003410 M Sheep, fat 0.020000 1.000 1.000 26003411 M Sheep, fat

- babyfood 0.020000 1.000 1.000 26003420 M Sheep, kidney 0.040000 1.000 1.000 26003430 M Sheep, liver 0.040000 1.000 1.000

95003620 O S ugarcane, sugar 0.800000 1.000 1.000 95003621 O Sugarcane, sugar

- babyfood 0.800000 1.000 1.000 95003630 O Sugarcane, molasses 2.500000 1.000 1.000 95003631 O Sugarcane, molass es

- babyfood 2.500000 1.000 1.000 15003810 15 Triticale, flour 4.000000 1.000 1.000 15003811 15 Triticale, flour

- babyfood 4.000000 1.000 1.000 86010000 O Water, direct, all sources 0.000980 1.000 1.000 86020000 O Water, indirect, all sources 0.000980 1.000 1.000 15004010 15 Wheat, grain 4.000000 1.000 1.000 15004011 15 Wheat, grain

- babyfood 4.000000 1.000 1.000 15004020 15 Wheat, flour 4.000000 1.000 1.000 15004021 15 Wheat, flour

- babyfood 4.000000 1.000 1.000

15004030 15 Wh eat, germ 4.000000 1.000 1.000 15004040 15 Wheat, bran 6.000000 1.000 1.000



### Attachment 4: Trinexapac

- ethyl Chronic Result File

- Food + WaterTrinexapac

- ethyl Dietar y Exposure Assessment DP Barcode: 394830



### Page 12 of 12 U.S. Environmental Protection Agency Ver. 2.00

DEEM

- FCID Chronic analysis for TRINEXAPAC

- ETHYL (1994

- 98 data)

Residue file name: C: \ Deemfcid \ Trinexapac \ Trinexapac_chronic.R98 Adjustment factor #2 NOT use d. Analysis Date 09

- 22

- 2011/14:21:10 Residue file dated: 09

- 22

- 2011/14:20:38/8 Reference dose (RfD, Chronic) = .32 mg/kg bw/day COMMENT 1: food + drinking water

=============================================================================== Total exposure by population subgroup

-------------------------------------------------------------------------------

Total Exposure

-------------------- --------------- Population mg/kg Percent of Subgroup body wt/day Rfd

-------------------------------------- ------------- --------------- U.S. Population (total) 0.007871 2.5%

U.S. Population (spring season) 0.007976 2.5% U.S. Population (summer season) 0.007598 2.4% U.S. Population (autumn season) 0.007924 2.5% U.S. Population (winter season) 0.007998 2.5%

Northeast region 0.008330 2.6% Midwest region 0.008367 2. 6% Southern region 0.007336 2.3% Western region 0.007780 2.4%

Hispanics 0.007156 2.2%

Non

- hispanic whites 0.008093 2.5%

Non

- hispanic blacks 0.007394 2.3%

Non

- hisp/non

- white/non

- black 0.007303 2.3%

All infants (< 1 year) 0.005464 1.7% Nursing infants 0.003066 1.0%

Non

- nursing infants 0.006375 2.0%

Children 1

- 6 yrs 0.018960 5.9%

Children 7

- 12 yrs 0.012508 3.9%

Females 13

- 19 (not preg or nursing) 0.006776 2.1% Females 20+ (not preg or nursing) 0.005372 1.7%

Females 13

- 50 yrs 0.006125 1.9% Females 13+ (preg/not nursing) 0.006438 2.0% Females 13+ (nursing) 0.007433 2.3%

Males 13

- 19 yrs 0.008456 2.6% Males 20+ yrs 0.006416 2.0%

Seniors 55+ 0.005182 1.6%

Children 1

- 2 yrs 0.019478 6.1%

Children 3

- 5 yrs 0.01 9272 6.0%

Children 6

- 12 yrs 0.013190 4.1%

Youth 13

- 19 yrs 0.007646 2.4%

Adults 20

- 49 yrs 0.006272 2.0%

Adults 5 0+ yrs 0.005224 1.6%

Females 13

- 49 yrs 0.005884 1.8%

-------------------------------------------------------------------------------