UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

WASHINGTON, D.C. 20460 

OFFICE OF CHEMICAL SAFETY AND 

POLLUTION PREVENTION 

MEMORANDUM 

Date: September 12, 2013 

SUBJECT: Trinexapac-ethyl: Acute and Chronic Aggregate Dietary (Food and Drinking 

Water) Exposure and Risk Assessments to Support Registration Review. 

PC Code: 112602 

Decision No.: 481872 

Petition No.: NA 

DP Barcode: D413986 

Registration No.: NA 

Regulatory Action: Registration Review 

Risk Assessment Type: Dietary CaseNo.: NA 

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

MRIDNo.: NA 40 CFR: §180.662 

FROM: 

THROUGH: 

TO: 

Sheila 

Risk Assessment 

Piper, Chemist 

Branch 

0heJa_; 

VI 

~ 

Health Effects Division (7509P) 

Nancy Dodd, Chemist "/' ~ ~~· ( 

Ideliz Negron Encarnacion, Cfiemist 

Dietary Exposure Science Advisory Coun fll C?£SAC) 

F eleci:;:rt, Branch Chief 1» (/( ()r J c:J;;{ 

Risk Assessment Branch VI, tbf'r{(7509P) 

Kaitlin Keller, Chemical Review Manager 

Risk Management and Implementation Branch 3 

Pesticide Re-Evaluation Division (7508P) 

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 

Page 1 of 12 
Trinexapac-ethyl Dietary Exposure and Risk Assessment DP Number: 413986

Page 2 of 12

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

dietary analysis is updated to reflect the latest consumption data and to support registration 

review. 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 drinking water estimate was based on the use of trinexapac-ethyl on 

turf in PA. The acute drinking water concentration in surface water is 12.61 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 0.014057 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 1.56 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 0.007535 

mg/kg/day for the U.S. population which is equivalent to 2% of the chronic Population Adjusted 

Dose (cPAD), and 0.019416 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.

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 
Trinexapac-ethyl Dietary Exposure and Risk Assessment DP Number: 413986

Page 3 of 12

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

(10/28/2011, D394830).

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 throughout the U.S. 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 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.
Trinexapac-ethyl Dietary Exposure and Risk Assessment DP Number: 413986

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Table 1: Tolerance Summary for Trinexapac-ethyl.

Commodity Established 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. Percent Crop Treated Information

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

with trinexapac-ethyl.
Trinexapac-ethyl Dietary Exposure and Risk Assessment DP Number: 413986

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IV. Drinking Water Data

References: Trinexapac-Ethyl Drinking Water Assessment to Support Registration Review,

D409833, Christopher M. Koper, 03/11/2013.

A Tier II screening-level drinking water assessment was conducted to support the human 

health risk assessment for the first food use registration for trinexapac-ethyl on cereals (wheat, 

barley, oats) and sugarcane. Since there are no recent actions, the estimated drinking water 

concentrations (EDWCs) generated for turf use still hold precedence. For surface water, a 

foliar ground application to Pennsylvania turf yielded the highest EDWCs. The 1-in-10 yr 

annual peak (acute) concentration was 12.61 μg/L, the 1-in-10 yr annual mean (chronic) 

concentration was 1.56 μg/L and the 30-year annual mean (cancer chronic) concentration was 

1.04 μg/L. For groundwater, based on the proposed highest annual use rate for turf, the SCIGROW model estimated the trinexapac ethyl concentration at 0.009 μg/L. 

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. Trinexapac-Ethyl Estimated Drinking Water Concentrations (EDWCs)1for 

Surface Water and Ground Water based on selected Crop Scenarios

Label Use

PRZM/EXAMS

Scenario1

(first app date)

Method2

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)

Primo® WSB

Surface Water

Turf 

FL Turf

(Feb 15 – foliar) G 8 app @ 0.34 lb a.i./acre 10.16 1.22 0.84

PA Turf

(April 15 – foliar) G 8 app @ 0.34 lb a.i./acre 12.61 1.56 1.04

Ground Water

SCIGROW Turf -- 8 app @ 0.34 lb a.i./acre 0.009 0.009 0.009

1 For surface water (PRZM/EXAMS), EDWC values adjusted with a Percent Cropped Area (PCA) factor of 1.0. For 

ground water (SCI-GROW), no PCA adjustment was utilized. 

2 G = ground application.

Bold numbers denote maximum EDWC values. 
Trinexapac-ethyl Dietary Exposure and Risk Assessment DP Number: 413986

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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 

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 
Trinexapac-ethyl Dietary Exposure and Risk Assessment DP Number: 413986

Page 7 of 12

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

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

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 
Trinexapac-ethyl Dietary Exposure and Risk Assessment DP Number: 413986

Page 8 of 12

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 95th 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 0.014057

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 0.007535

mg/kg/day for the general U.S. population equivalent to 2% of the cPAD and 0.019416

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 and Drinking Water) Exposure and Risk for Trinexapacethyl

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 0.007535 2.4

N/A N/A

All Infants (< 1 year 

old) 0.006360 2.0

Children 1-2 years old 0.019416 6.1

Children 3-5 years old 0.018520 5.8

Children 6-12 years old 0.013294 4.2

Youth 13-19 years old 0.007701 2.4

Adults 20-49 years old 0.006093 1.9

Adults 50-99+ years old 0.005137 1.6

Females 13-49 years 

old1

0.014057 2

0.005741 1.8

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.
Trinexapac-ethyl Dietary Exposure and Risk Assessment DP Number: 413986

Page 9 of 12

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.

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

Filename: C:\Deemfcid\Trinexapac\Trinexapac_acute.r08Chemical: Trinexapac-ethyl

RfD(Chronic): .32 mg/kg bw/day NOEL(Chronic): 31.6 mg/kg bw/day

RfD(Acute): .6 mg/kg bw/day NOEL(Acute): 60 mg/kg bw/day

Date created/last modified: 08-10-2013/13:23:12 Program ver. 3.16, 03-08-d

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

 EPA Crop Def Res Adj.Factors Comment

 Code Grp Commodity Name (ppm) #1 #2 

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

9500363000 O Sugarcane, molasses 2.500000 1.000 1.000 

9500363001 O Sugarcane, molasses-babyfood 2.500000 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 

1500027000 15 Barley, bran 2.500000 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 

1500025000 15 Barley, pearled barley 2.000000 1.000 1.000 

1500025001 15 Barley, pearled barley-babyfood 2.000000 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 

1500404000 15 Wheat, bran 6.000000 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 

1500401000 15 Wheat, grain 4.000000 1.000 1.000 

1500401001 15 Wheat, grain-babyfood 4.000000 1.000 1.000 
Trinexapac-ethyl Dietary Exposure and Risk Assessment DP Number: 413986

Page 10 of 12

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 

3100044000 31 Beef, meat 0.020000 1.000 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 

3100045000 31 Beef, meat, dried 0.020000 1.920 1.000 

3100044001 31 Beef, meat-babyfood 0.020000 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 

3200169000 32 Goat, meat 0.020000 1.000 1.000 

3200170000 32 Goat, meat byproducts 0.040000 1.000 1.000 

3300189000 33 Horse, meat 0.020000 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 

3400290000 34 Pork, meat 0.020000 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 

3400290001 34 Pork, meat-babyfood 0.020000 1.000 1.000 

3400291000 34 Pork, skin 0.030000 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 

3500339000 35 Sheep, meat 0.020000 1.000 1.000 

3500340000 35 Sheep, meat byproducts 0.040000 1.000 1.000 

3500339001 35 Sheep, meat-babyfood 0.020000 1.000 1.000 

8601000000 86A Water, direct, all sources 0.012610 1.000 1.000 

8602000000 86B Water, indirect, all sources 0.012610 1.000 1.000 

Attachment 2: Acute Results File

US EPA Ver. 3.16, 03-08-d

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

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

Analysis Date: 08-10-2013/13:27:18 Residue file dated: 08-10-2013/13:23:12

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:

 0.014057 2.34 4268 0.021466 3.58 2795 0.031711 5.29 1892

Attachment 3: Chronic Residue Input File

Filename: C:\Deemfcid\Trinexapac\Trinexapac_chronic.r08

Chemical: Trinexapac-ethyl

RfD(Chronic): .32 mg/kg bw/day NOEL(Chronic): 31.6 mg/kg bw/day

RfD(Acute): .6 mg/kg bw/day NOEL(Acute): 60 mg/kg bw/day

Date created/last modified: 08-10-2013/13:29:36 Program ver. 3.16, 03-08-d

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

 EPA Crop Def Res Adj.Factors Comment

 Code Grp Commodity Name (ppm) #1 #2 
Trinexapac-ethyl Dietary Exposure and Risk Assessment DP Number: 413986

Page 11 of 12

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

9500363000 O Sugarcane, molasses 2.500000 1.000 1.000 

9500363001 O Sugarcane, molasses-babyfood 2.500000 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 

1500027000 15 Barley, bran 2.500000 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 

1500025000 15 Barley, pearled barley 2.000000 1.000 1.000 

1500025001 15 Barley, pearled barley-babyfood 2.000000 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 

1500404000 15 Wheat, bran 6.000000 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 

1500401000 15 Wheat, grain 4.000000 1.000 1.000 

1500401001 15 Wheat, grain-babyfood 4.000000 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 

3100044000 31 Beef, meat 0.020000 1.000 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 

3100045000 31 Beef, meat, dried 0.020000 1.920 1.000 

3100044001 31 Beef, meat-babyfood 0.020000 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 

3200169000 32 Goat, meat 0.020000 1.000 1.000 

3200170000 32 Goat, meat byproducts 0.040000 1.000 1.000 

3300189000 33 Horse, meat 0.020000 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 

3400290000 34 Pork, meat 0.020000 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 

3400290001 34 Pork, meat-babyfood 0.020000 1.000 1.000 

3400291000 34 Pork, skin 0.030000 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 

3500339000 35 Sheep, meat 0.020000 1.000 1.000 

3500340000 35 Sheep, meat byproducts 0.040000 1.000 1.000 

3500339001 35 Sheep, meat-babyfood 0.020000 1.000 1.000 

8601000000 86A Water, direct, all sources 0.001560 1.000 1.000 

8602000000 86B Water, indirect, all sources 0.001560 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:\Deemfcid\Trinexapac\Trinexapac_chronic.r08

 Adjustment factor #2 NOT used.

Analysis Date 08-10-2013/13:30:05 Residue file dated: 08-10-2013/13:29:36
Trinexapac-ethyl Dietary Exposure and Risk Assessment DP Number: 413986

Page 12 of 12

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

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 Total exposure by population subgroup

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 Total Exposure

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

 Population mg/kg Percent of 

 Subgroup body wt/day Rfd 

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

Total US Population 0.007535 2.4%

Hispanic 0.007478 2.3%

Non-Hisp-White 0.007665 2.4%

Non-Hisp-Black 0.006890 2.2%

Non-Hisp-Other 0.007472 2.3%

Nursing Infants 0.004211 1.3%

Non-Nursing Infants 0.007319 2.3%

Female 13+ PREG 0.006240 1.9%

Children 1-6 0.018809 5.9%

Children 7-12 0.012430 3.9%

Male 13-19 0.008464 2.6%

Female 13-19/NP 0.006973 2.2%

Male 20+ 0.006271 2.0%

Female 20+/NP 0.005144 1.6%

Seniors 55+ 0.005062 1.6%

All Infants 0.006360 2.0%

Female 13-50 0.005709 1.8%

Children 1-2 0.019416 6.1%

Children 3-5 0.018520 5.8%

Children 6-12 0.013294 4.2%

Youth 13-19 0.007701 2.4%

Adults 20-49 0.006093 1.9%

Adults 50-99 0.005137 1.6%

Female 13-49 0.005741 1.8%

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