UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

WASHINGTON, D.C. 20460 

OFFICE OF CHEMICAL SAFETY AND 

POLLUTION PREVENTION 

MEMORANDUM 

Date: February 11, 20 l 5 

SUBJECT: Trinexapac-ethyl: Acute and Chronic Aggregate Dietary and Drinking Water 

Exposure and Risk Assessments to Support new use on Rice and Rye. 

PC Code: 112602 

Decision No.: 488373 

Petition No.: NA 

DP Barcode: D4j 4893 

Registration No.: NA 

Regulatory Action: Registration Review 

Risk Assessment Type: Dietary Case No.: NA 

TXRNo.: NA CAS No.: 95266-40-3 

MRIDNo.:NA 40 CFR: §180.662 

FROM: 

THROUGH: 

TO: 

Sumitra Bose Biswas, Chemist 

Risk Assessment Branch VI 

Health Effects Division (7509P) 

Sheila 

ldeliz Negron-Encarnacion

Piper, Chemis~~, Chemist ~ .::;./,, L'~-----

Dietary Exposure Science Advisory Counc (DESAC) 

And ' 

Donna 

Risk Assessment 

S. Davis, Acting 

Branch 

Branch 

VI, HED 

Chief 

(7509P) 

~ 

Bethany Benbow, Risk Manager Reviewer 

Kathryn Montague, Risk Manager 

Dan Kenny, Branch Chief 

Risk Management and Implementation Branch 3 

Pesticide Re-Evaluation Division (7508P) 

Page I of 12 
Trinexapac-ethyl Dietary Exposure and Risk Assessment DP Number: D424893

Page 2 of 12

Executive Summary

Acute and chronic aggregate dietary food and drinking water exposure and risk assessments for 

trinexapac-ethyl were conducted using the Dietary Exposure Evaluation Model software with the 

Food Commodity Intake Database (DEEM-FCID) Version 3.16. This software uses 2003-2008 

food consumption data from the U.S. Department of Agriculture’s (USDA’s) National Health and 

Nutrition Examination Survey, What We Eat in America, (NHANES/WWEIA). This dietary 

analysis is updated to reflect the new uses on rice and rye. This memorandum was reviewed by 

two peer reviewers of the DESAC per the current DESAC Standard Operating Procedure (SOP).

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

An unrefined, acute dietary exposure assessment using tolerance-level residues, default DEEM 

processing factors, and assuming 100% crop treated (CT) for the registered commodities was 

conducted. 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 Tier I Rice Model was used to generate EDWCs for residues of trinexapac-ethyl 

on surface water which were obtained modeling the rice use. The acute drinking water 

concentration in surface water is 31.68 ppb.

There were no appropriate toxicological effects attributable to a single exposure (dose) for the 

general population or any other population subgroups except females 13-49 years old; therefore,

these population subgroups were not included in this assessment. 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 95th percentile of exposure. The acute dietary exposure estimate for 

females 13-49 years old is 0.014667 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 tolerance level

residues, default DEEM processing factors, and 100% CT. The chronic EDWC in surface water 

for trinexapac-ethyl is 31.68 ppb. 

Combined chronic dietary exposure estimates for food and drinking water are well below HED’s 

level of concern. Using the DEEM-FCID software, dietary exposure is estimated at 0.008293

mg/kg/day for the U.S. population which is equivalent to 3% of the chronic Population Adjusted 

Dose (cPAD), and 0.020596 mg/kg/day, equivalent to 6% of the cPAD for children 1-2 years old, 

the population with highest estimated chronic dietary exposure to trinexapac-ethyl.

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

Trinexapac-ethyl is classified as “not likely to be carcinogenic to humans.” Therefore, a cancer 

dietary exposure analysis is not required.
Trinexapac-ethyl Dietary Exposure and Risk Assessment DP Number: D424893

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 

(i.e., the dose that HED has concluded will result in no unreasonable adverse health effects). 

This dose is referred to as the population adjusted dose (PAD). The PAD is equivalent to the 

point of departure (POD, NOAEL, LOAEL, e.g.) divided by the required uncertainty or safety 

factors.

For acute and non-cancer chronic exposures, HED is concerned when estimated dietary risk 

exceeds 100% of the PAD. References that 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,” 21-JUN-2000, web link: 

http://www.epa.gov/fedrgstr/EPA-PEST/2000/July/Day-12/6061.pdf; or see SOP 99.6 (20-AUG1999).

The most recent dietary risk assessment for trinexapac-ethyl was conducted by S. Piper

(09/12/2013, D413986).

II. Residue Information

Trinexapac-ethyl is a plant growth regulator being proposed by Syngenta Crop Protection for 

use on rice and rye. Trinexapac-ethyl inhibits internodal elongation and growth in cereal grains, 

grasses and several dicotyledonous species. Tolerances are currently established for residues of 

the plant growth inhibitor, trinexapac-ethyl in/on various plant and animal commodities, at levels 

ranging from 0.02 to 40.0 ppm as listed in the CFR 40 §180.662. 

The residues of concern in plants and livestock for tolerance enforcement and risk assessment 

purposes include free and conjugated residues of both parent and its acid metabolite, trinexapac 

(Residues of Concern Knowledgebase Subcommittee (ROCKS), D390121, 7/12/11).

Residue Data used for the Acute & Chronic Dietary Assessment:

An unrefined, acute dietary exposure assessment using tolerance level residues, default DEEM 

processing factors, and assuming 100% CT for the registered commodities. See Table 1.

Table 1: Tolerance Summary for Trinexapac-ethyl.

Commodity HED-Recommended 

Tolerance (ppm)

Comments 

Rice, grain 0.4 NA
Trinexapac-ethyl Dietary Exposure and Risk Assessment DP Number: D424893

Page 4 of 12

Rice, straw 0.07 NA

Rice, bran 1.7 NA

Rice, wild, grain 0.4 NA

Rye, bran 2.5

Extrapolation from the existing 

tolerances established for small cereal 

grains.

Rye, grain 4.0

Rye, hay 1.5

Rye, straw 0.9

III. Percent Crop Treated Information

The acute and chronic dietary analyses were performed assuming 100% of each crop was treated 

with trinexapac-ethyl.

IV. Drinking Water Data

References: Drinking Water Assessment for Trinexapac-Ethyl new use on rice and rye, D421848, 

Christopher M. Koper, 10/01/2014.

A Tier I rice model for drinking water assessment was conducted to support the human health 

risk assessment for the new food use registration for trinexapac ethyl on rice and rye. Rye, a 

cereal will not be modeled in this assessment since application rates are the same as previously 

assessed rates on cereals (D377936; 08-09-11). The recommended estimated drinking water 

concentrations (EDWCs) for the human health risk assessment are based on highest predicted 

values for surface water and ground water. For surface water, application (1 application at 

0.045 lb a.i./acre) to rice yielded the highest EDWCs. The acute and chronic concentrations 

were estimated to be 31.68 ppb. For ground water, based on the proposed highest annual use 

rate for turf (8 applications at 0.34 lb a.i./acre), the PRZM-GW (v.1.07) model estimated an 

acute concentration of 0.116 ppb and 30-year average (chronic) concentration of 0.054 ppb.

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

acid CGA-179500, 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.” Table 2 provides a summary of the Tier 2 

modeled drinking water concentrations. The model and its description are available at the EPA 

internet site: http://www.epa.gov/oppefed1/models/water/. 

Table 2. Recommended Trinexapac-Ethyl Estimated Drinking Water Concentrations

(EDWCs) for Surface Water and Ground Water based on selected Crop Scenarios
Trinexapac-ethyl Dietary Exposure and Risk Assessment DP Number: D424893

Page 5 of 12

Proposed

Label Use

Model Method

1 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

Rice Tier 1 Rice Model NA 1 app @ 0.045 lb a.i./acre

31.68

(12.61)

2

31.68

(1.56)

31.68

(1.04)

Ground Water

Turf PRZM-GW G 8 app @ 0.34 lb a.i./acre

0.116

(0.009)

NA 0.054

(0.009)

1 G = foliar, ground application, NA = Not Applicable.

2

Italicized values generated from turf scenario (parent D377936; sub D395601)

Bold numbers denote maximum EDWC values. Italicized numbers denote maximum EDWC values from previous 

drinking water assessment (parent D377936; Sub D395601; 10-28-11).

V. DEEM-FCID Program and Consumption Information

Trinexapac-ethyl acute and chronic dietary exposure assessments were conducted using the 

DEEM-FCID, Version 3.16, which incorporates 2003-2008 consumption data from USDA’s 

NHANES/WWEIA. The 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. For chronic exposure assessment, consumption data 

are averaged for the entire U.S. population and within population subgroups. However, for acute 

exposure assessment, consumption data are retained as individual consumption events. Based on 

analysis of the 2003-2008 WWEIA consumption data, which took into account dietary patterns 

and survey respondents, HED concluded that it is most appropriate to report risk for the 

following population subgroups: the general U.S. population, all infants (<1 year old), children 

1-2, children 3-5, children 6-12, youth 13-19, adults 20-49, females 13-49, and adults 50-99

years old.

For a chronic dietary exposure assessment, an estimate of the residue level in each food or foodform (e.g., orange or orange juice) on the food commodity residue list is multiplied by the 

average daily consumption estimate for that food/food form to produce a residue intake estimate. 

The resulting residue intake estimate for each food/food form is summed with the residue intake 

estimates for all other food/food forms on the commodity residue list to arrive at the total 

average estimated exposure. Exposure is expressed in mg/kg body weight/day and as a percent 

of the cPAD. This procedure is performed for each population subgroup.

For an acute exposure assessment, 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 
Trinexapac-ethyl Dietary Exposure and Risk Assessment DP Number: D424893

Page 6 of 12

deterministic exposure assessment, or “matched” in multiple random pairings with residue values 

and then summed in a probabilistic assessment. The resulting distribution of exposures is 

expressed as a percentage of the aPAD on both a user (i.e., only 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 analyses performed at all levels of refinement. However, for 

deterministic assessments, any significant differences in user vs. per capita exposure and risk are 

specifically identified and noted in the risk assessment.

VI. Toxicological Information

HED’s ToxSAC met (09/30/2011) 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 

identified 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 necessary. 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 children was available

Acute Dietary

(Females 13-49 

years of age)

NOAEL = 60 

mg/kg

UFA= 10x

UFH = 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

and early resorptions. 
Trinexapac-ethyl Dietary Exposure and Risk Assessment DP Number: D424893

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

Chronic Dietary

(All Populations)

NOAEL= 31.6 

mg/kg/day

UFA= 10x

UFH = 10x

FQPA SF= 

1x

Chronic RfD = 

0.32

mg/kg/day

cPAD = 0.32 

mg/kg/day

Chronic 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 lower environmentally relevant human exposures. NOAEL = no observed adverse effect 

level. LOAEL = lowest observed adverse effect level. UF = uncertainty factor. UFA = 

extrapolation from animal to human (interspecies). UFH = potential variation in sensitivity 

among members of the human population (intraspecies). FQPA SF = FQPA Safety Factor. 

PAD = population adjusted dose (a = acute, c = chronic). RfD = reference dose. 

VII. Results/Discussion 

As stated above, for acute and chronic assessments, HED is concerned when dietary risk exceeds 

100% of the PAD. The DEEM-FCID analyses estimate the dietary exposure of the U.S. 

population and various population subgroups. The results reported in Table 4 are for the general 

U.S. Population, all infants (<1 year old), children 1-2, children 3-5, children 6-12, youth 13-19, 

females 13-49, adults 20-49, and adults 50-99 years. 

For food and drinking water, the acute dietary risk estimate is 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 0.014667

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

Chronic 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 0.008293

mg/kg/day for the general U.S. population equivalent to 3% of the cPAD and 0.020596

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. 
Trinexapac-ethyl Dietary Exposure and Risk Assessment DP Number: D424893

Page 8 of 12

Table 4. Summary of Dietary (Food and Drinking Water) Exposure and Risk for Trinexapac-ethyl

Population Subgroup

Acute Dietary1

(95th% Percentile) Chronic Dietary Cancer

Dietary Exposure 

(mg/kg/day)

% 

aPAD

Dietary 

Exposure

(mg/kg/day)

% 

cPAD

Dietary 

Exposure

(mg/kg/day)

Risk

General U.S. 

Population

N/A N/A

0.008293 2.6

N/A N/A

All Infants (< 1 year 

old) 0.008387 2.6

Children 1-2 years 

old 0.020596 6.4

Children 3-5 years 

old 0.019487 6.1

Children 6-12 years 

old 0.013981 4.4

Youth 13-19 years 

old 0.008238 2.6

Adults 20-49 years 

old 0.006853 2.1

Adults 50-99+ years 

old 0.005861 1.8

Females 13-49 years 

old1

0.014667 2.4 0.006466 2.0

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. Not likely to be carcinogenic to humans.

VIII. Characterization of Inputs/Outputs

The assumptions made in this acute and chronic dietary assessment are conservative; including 

tolerance-level residues and assuming 100% crop treated. A refined analysis incorporating 

additional refinements, including % crop treated data, is not warranted at this time since the risk 

estimates are below HED’s level of concern.
Trinexapac-ethyl Dietary Exposure and Risk Assessment DP Number: D424893

Page 9 of 12

IX. Conclusions

These highly conservative, unrefined analyses demonstrate 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. 

HED is confident that the assessment does not underestimate risk to the general U.S. population 

or any population subgroup. 

X. List of Attachments

Attachment 1: Acute Residue Input File

Attachment 2: Acute Results File

Attachment 3: Chronic Residue Input File

Attachment 4: Chronic Results File

Attachment 1: Acute Residue Input File

US EPA Ver. 3.18, 03-08-d

DEEM-FCID Acute analysis for TRINEXAPAC-ETHYL

Residue file name: C:\DEEM\Trinex\Trinexapac_acute2.r08

Analysis Date 02-04-2015 Residue file dated: 02-04-2015/11:00:00

Reference dose: aRfD = 0.6 mg/kg bw/day NOEL = 60 mg/kg bw/day

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

 EPA Crop Def Res Adj.Factors Comment

 Code Grp Food Name (ppm) #1 #2 

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

1500025000 15 Barley, pearled barley 2.000000 1.000 1.000

1500025001 15 Barley, pearled barley-babyfood 2.000000 1.000 1.000

1500026000 15 Barley, flour 2.000000 1.000 1.000

1500026001 15 Barley, flour-babyfood 2.000000 1.000 1.000

1500027000 15 Barley, bran 2.500000 1.000 1.000

3100044000 31 Beef, meat 0.020000 1.000 1.000

3100044001 31 Beef, meat-babyfood 0.020000 1.000 1.000

3100045000 31 Beef, meat, dried 0.020000 1.920 1.000

3100046000 31 Beef, meat byproducts 0.040000 1.000 1.000

3100046001 31 Beef, meat byproducts-babyfood 0.040000 1.000 1.000

3100047000 31 Beef, fat 0.020000 1.000 1.000

3100047001 31 Beef, fat-babyfood 0.020000 1.000 1.000

3100048000 31 Beef, kidney 0.040000 1.000 1.000

3100049000 31 Beef, liver 0.040000 1.000 1.000

3100049001 31 Beef, liver-babyfood 0.040000 1.000 1.000

3200169000 32 Goat, meat 0.020000 1.000 1.000

3200170000 32 Goat, meat byproducts 0.040000 1.000 1.000

3200171000 32 Goat, fat 0.020000 1.000 1.000

3200172000 32 Goat, kidney 0.040000 1.000 1.000

3200173000 32 Goat, liver 0.040000 1.000 1.000

3300189000 33 Horse, meat 0.020000 1.000 1.000

1500231000 15 Oat, bran 6.000000 1.000 1.000

1500232000 15 Oat, flour 4.000000 1.000 1.000

1500232001 15 Oat, flour-babyfood 4.000000 1.000 1.000

1500233000 15 Oat, groats/rolled oats 4.000000 1.000 1.000
Trinexapac-ethyl Dietary Exposure and Risk Assessment DP Number: D424893

Page 10 of 12

1500233001 15 Oat, groats/rolled oats-babyfood 4.000000 1.000 1.000

3400290000 34 Pork, meat 0.020000 1.000 1.000

3400290001 34 Pork, meat-babyfood 0.020000 1.000 1.000

3400291000 34 Pork, skin 0.030000 1.000 1.000

3400292000 34 Pork, meat byproducts 0.030000 1.000 1.000

3400292001 34 Pork, meat byproducts-babyfood 0.030000 1.000 1.000

3400293000 34 Pork, fat 0.020000 1.000 1.000

3400293001 34 Pork, fat-babyfood 0.020000 1.000 1.000

3400294000 34 Pork, kidney 0.030000 1.000 1.000

3400295000 34 Pork, liver 0.030000 1.000 1.000

1500323000 15 Rice, white 0.400000 1.000 1.000

1500323001 15 Rice, white-babyfood 0.400000 1.000 1.000

1500324000 15 Rice, brown 0.400000 1.000 1.000

1500324001 15 Rice, brown-babyfood 0.400000 1.000 1.000

1500325000 15 Rice, flour 0.400000 1.000 1.000

1500325001 15 Rice, flour-babyfood 0.400000 1.000 1.000

1500326000 15 Rice, bran 1.500000 1.000 1.000

1500326001 15 Rice, bran-babyfood 1.500000 1.000 1.000

1500328000 15 Rye, grain 4.000000 1.000 1.000

1500329000 15 Rye, flour 4.000000 1.000 1.000

3500339000 35 Sheep, meat 0.020000 1.000 1.000

3500339001 35 Sheep, meat-babyfood 0.020000 1.000 1.000

3500340000 35 Sheep, meat byproducts 0.040000 1.000 1.000

3500341000 35 Sheep, fat 0.020000 1.000 1.000

3500341001 35 Sheep, fat-babyfood 0.020000 1.000 1.000

3500342000 35 Sheep, kidney 0.040000 1.000 1.000

3500343000 35 Sheep, liver 0.040000 1.000 1.000

9500362000 O Sugarcane, sugar 0.800000 1.000 1.000

9500362001 O Sugarcane, sugar-babyfood 0.800000 1.000 1.000

9500363000 O Sugarcane, molasses 2.500000 1.000 1.000

9500363001 O Sugarcane, molasses-babyfood 2.500000 1.000 1.000

8601000000 86A Water, direct, all sources 0.031680 1.000 1.000

8602000000 86B Water, indirect, all sources 0.031680 1.000 1.000

1500401000 15 Wheat, grain 4.000000 1.000 1.000

1500401001 15 Wheat, grain-babyfood 4.000000 1.000 1.000

1500402000 15 Wheat, flour 4.000000 1.000 1.000

1500402001 15 Wheat, flour-babyfood 4.000000 1.000 1.000

1500403000 15 Wheat, germ 4.000000 1.000 1.000

1500404000 15 Wheat, bran 6.000000 1.000 1.000

Attachment 2: Acute Results File

US EPA Ver. 3.18, 03-08-d

DEEM-FCID ACUTE Analysis for TRINEXAPAC-ETHYL NHANES 2003-2008 2-Day

Residue file: Trinexapac_acute2.r08 Adjustment factor #2 NOT used.

Analysis Date: 02-04-2015/11:10:17 Residue file dated: 02-04-2015/11:00:00

NOEL (Acute) = 60.000000 mg/kg body-wt/day

RAC/FF intake summed over 24 hours

Run Comment: ""

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

Summary calculations--per capita:

--- 95th Percentile---- --- 99th Percentile---- ---99.9th Percentile----

Exposure % aRfD MOE Exposure % aRfD MOE Exposure % aRfD MOE 

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

Female 13-49:

 0.014667 2.44 4090 0.022173 3.70 2706 0.032025 5.34 1873 
Trinexapac-ethyl Dietary Exposure and Risk Assessment DP Number: D424893

Page 11 of 12

Attachment 3: Chronic Residue Input File

US EPA Ver. 3.16, 03-08-d

DEEM-FCID Chronic analysis for TRINEXAPAC-ETHYL

Residue file: C:\DEEM\Trinex\Trinexapac_chronic2.r08 Adjust. #2 NOT used

Analysis Date 02-04-2015 Residue file dated: 02-04-2015/10:59:06

Reference dose (RfD) = 0.32 (NOEL) = 31.6 mg/kg bw/day

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

Food Crop Residue Adj.Factors

EPA Code Grp Food Name (ppm) #1 #2 

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

1500025000 15 Barley, pearled barley 2.000000 1.000 1.000 

1500025001 15 Barley, pearled barley-babyfood 2.000000 1.000 1.000 

1500026000 15 Barley, flour 2.000000 1.000 1.000 

1500026001 15 Barley, flour-babyfood 2.000000 1.000 1.000 

1500027000 15 Barley, bran 2.500000 1.000 1.000 

3100044000 31 Beef, meat 0.020000 1.000 1.000 

3100044001 31 Beef, meat-babyfood 0.020000 1.000 1.000 

3100045000 31 Beef, meat, dried 0.020000 1.920 1.000 

3100046000 31 Beef, meat byproducts 0.040000 1.000 1.000 

3100046001 31 Beef, meat byproducts-babyfood 0.040000 1.000 1.000 

3100047000 31 Beef, fat 0.020000 1.000 1.000 

3100047001 31 Beef, fat-babyfood 0.020000 1.000 1.000 

3100048000 31 Beef, kidney 0.040000 1.000 1.000 

3100049000 31 Beef, liver 0.040000 1.000 1.000 

3100049001 31 Beef, liver-babyfood 0.040000 1.000 1.000 

3200169000 32 Goat, meat 0.020000 1.000 1.000 

3200170000 32 Goat, meat byproducts 0.040000 1.000 1.000 

3200171000 32 Goat, fat 0.020000 1.000 1.000 

3200172000 32 Goat, kidney 0.040000 1.000 1.000 

3200173000 32 Goat, liver 0.040000 1.000 1.000 

3300189000 33 Horse, meat 0.020000 1.000 1.000 

1500231000 15 Oat, bran 6.000000 1.000 1.000 

1500232000 15 Oat, flour 4.000000 1.000 1.000 

1500232001 15 Oat, flour-babyfood 4.000000 1.000 1.000 

1500233000 15 Oat, groats/rolled oats 4.000000 1.000 1.000 

1500233001 15 Oat, groats/rolled oats-babyfood 4.000000 1.000 1.000 

3400290000 34 Pork, meat 0.020000 1.000 1.000 

3400290001 34 Pork, meat-babyfood 0.020000 1.000 1.000 

3400291000 34 Pork, skin 0.030000 1.000 1.000 

3400292000 34 Pork, meat byproducts 0.030000 1.000 1.000 

3400292001 34 Pork, meat byproducts-babyfood 0.030000 1.000 1.000 

3400293000 34 Pork, fat 0.020000 1.000 1.000 

3400293001 34 Pork, fat-babyfood 0.020000 1.000 1.000 

3400294000 34 Pork, kidney 0.030000 1.000 1.000 

3400295000 34 Pork, liver 0.030000 1.000 1.000 

1500323000 15 Rice, white 0.400000 1.000 1.000 

1500323001 15 Rice, white-babyfood 0.400000 1.000 1.000 

1500324000 15 Rice, brown 0.400000 1.000 1.000 

1500324001 15 Rice, brown-babyfood 0.400000 1.000 1.000 

1500325000 15 Rice, flour 0.400000 1.000 1.000 

1500325001 15 Rice, flour-babyfood 0.400000 1.000 1.000 

1500326000 15 Rice, bran 1.500000 1.000 1.000 

1500326001 15 Rice, bran-babyfood 1.500000 1.000 1.000 

1500328000 15 Rye, grain 4.000000 1.000 1.000 

1500329000 15 Rye, flour 4.000000 1.000 1.000 

3500339000 35 Sheep, meat 0.020000 1.000 1.000 

3500339001 35 Sheep, meat-babyfood 0.020000 1.000 1.000 

3500340000 35 Sheep, meat byproducts 0.040000 1.000 1.000 

3500341000 35 Sheep, fat 0.020000 1.000 1.000 

3500341001 35 Sheep, fat-babyfood 0.020000 1.000 1.000 
Trinexapac-ethyl Dietary Exposure and Risk Assessment DP Number: D424893

Page 12 of 12

3500342000 35 Sheep, kidney 0.040000 1.000 1.000 

3500343000 35 Sheep, liver 0.040000 1.000 1.000 

9500362000 O Sugarcane, sugar 0.800000 1.000 1.000 

9500362001 O Sugarcane, sugar-babyfood 0.800000 1.000 1.000 

9500363000 O Sugarcane, molasses 2.500000 1.000 1.000 

9500363001 O Sugarcane, molasses-babyfood 2.500000 1.000 1.000 

8601000000 86A Water, direct, all sources 0.031680 1.000 1.000 

8602000000 86B Water, indirect, all sources 0.031680 1.000 1.000 

1500401000 15 Wheat, grain 4.000000 1.000 1.000 

1500401001 15 Wheat, grain-babyfood 4.000000 1.000 1.000 

1500402000 15 Wheat, flour 4.000000 1.000 1.000 

1500402001 15 Wheat, flour-babyfood 4.000000 1.000 1.000 

1500403000 15 Wheat, germ 4.000000 1.000 1.000 

1500404000 15 Wheat, bran 6.000000 1.000 1.000 

Attachment 4: Chronic Results File

US EPA Ver. 3.16, 03-08-d

DEEM-FCID Chronic analysis for TRINEXAPAC-ETHYL NHANES 2003-2008 2-day

Residue file name: C:\DEEM\Trinex\Trinexapac_chronic2.r08

 Adjustment factor #2 NOT used.

Analysis Date 02-04-2015/11:00:27 Residue file dated: 02-04-2015/10:59:06

Reference dose (RfD, Chronic) = .32 mg/kg bw/day

NOEL (Chronic) = 31.6 mg/kg bw/day

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

 Total exposure by population subgroup

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

 Total Exposure

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

 Population mg/kg Margin of Percent 

 Subgroup body wt/day Exposure of RfD 

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

Total US Population 0.008293 3,811 2.6%

Hispanic 0.008242 3,834 2.6%

Non-Hisp-White 0.008420 3,753 2.6%

Non-Hisp-Black 0.007520 4,202 2.4%

Non-Hisp-Other 0.008555 3,694 2.7%

Nursing Infants 0.005042 6,268 1.6%

Non-Nursing Infants 0.009880 3,198 3.1%

Female 13+ PREG 0.006940 4,553 2.2%

Children 1-6 0.019833 1,593 6.2%

Children 7-12 0.013088 2,414 4.1%

Male 13-19 0.008971 3,522 2.8%

Female 13-19/NP 0.007540 4,191 2.4%

Male 20+ 0.007001 4,513 2.2%

Female 20+/NP 0.005903 5,354 1.8%

Seniors 55+ 0.005766 5,481 1.8%

All Infants 0.008387 3,768 2.6%

Female 13-50 0.006434 4,911 2.0%

Children 1-2 0.020596 1,534 6.4%

Children 3-5 0.019487 1,622 6.1%

Children 6-12 0.013981 2,260 4.4%

Youth 13-19 0.008238 3,836 2.6%

Adults 20-49 0.006853 4,611 2.1%

Adults 50-99 0.005861 5,391 1.8%

Female 13-49 0.006466 4,887 2.0%