Quinclorac (PC Code 128974) Dietary Exposure and Risk Assessment DP# 406419 

DMA Salt ofQuinclorac (PC Code 028974) 

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

WASHINGTON, D.C. 20460 

MEMORANDUM 

DATE: August 1, 2013 

OFFICE OF CHEMICAL SAFETY 

AND POLLUTION PREVENTION 

SUBJECT: Quinclorac and the Dimethylamine (DMA) Salt of Quinclorac. Acute and 

Chronic Aggregate Dietary (Food and Drinking Water) Exposure and Risk 

Assessments for the Proposed Tolerance with No U.S. Registration for Rapeseed 

Subgroup 20A. 

PC Codes: 128974 and 028974 

Decision Number: 464830 

Petition Number: 2E8035 

DP Barcode: D406419 

Registration Number: Not Applicable 

Regulatory Action: Tolerance with No U.S. 

Registration 

Assessment Type: Single Chemical/Aggregate Case Number: 7222 

TXR Number: Not Applicable CAS Number: 84087-01-4; 84087-48-9 

MRID Number: Not Applicable 40CFR § 180.463 

FROM: Bonnie 

Risk Assessme

Cropp-Kohl

nt Branch 

ligian, 

IV 

Envi

(RABIV), 

ronmental 

Health 

Scient~~ E~~i ision (HED) ~-(7509~ ~ \ ~ 0 

THROUGH: Thurston Morton, Chemist, Senior Scientist ·">/ ':.5<{ RABIV, HED (7509P) 

and 

DouglasDotson Ph.D. Che~· t fi.J)~ 

Kristin Rury, Biologist \L 

Dietary Exposure Science Adviso Co cil (DESAC), HED (7509P) 

TO: Maggie Rudick and Kable Davis, PM#25 

Herbicide Branch, Registration Division (7505P) 

Executive Summary 

Acute and chronic aggregate dietary (food and drinking water) exposure and risk assessments 

were conducted using the Dietary Exposure Evaluation Model DEEM-FCID, Version 3.16 which 

uses food consumption data from the U.S. Department of Agriculture's National Health and 

Page 1 of 16 
Quinclorac (PC Code 128974) Dietary Exposure and Risk Assessment DP# 406419 

DMA Salt ofQuinclorac (PC Code 028974) 

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

survey was conducted from 2003 to 2008. These analyses were performed to support the 

proposed tolerance with no U.S. registration for quinclorac in/on Rapeseed Subgroup 20A for the 

use of the DMA salt of quinclorac in Canada. All registered, pending and proposed uses of 

quinclorac and the DMA salt of quinclorac, as of the date of this memorandum, are included in 

these assessments. This memorandum was reviewed by two peer reviewers of the DESAC, per 

DESAC SOP 2012.1. 

Tolerances have been established for quinclorac (40CFR §180.463[a]) in/on barley, grain; berry, 

low growing, except strawberry, subgroup 13-07H; aspirated grain fractions; grass commodities; 

rhubarb; rice commodities; grain sorghum commodities; wheat commodities; and livestock 

commodities. 

The HED risk assessment team has determined that, for the uses under consideration, quinclorac 

and the DMA salt of quinclorac may be considered equivalent. 

Neither quinclorac nor the DMA salt of quinclorac has been considered by the HED Residues of 

Concern Knowledge base Subcommittee (ROCKS) or any of its predecessors. Now, based on 

previously submitted rice, grain sorghum, and wheat metabolism data and newly submitted 

canola metabolism data, the HED quinclorac and DMA salt of quinclorac risk assessment team 

has determined that the residues of concern for the currently registered and proposed uses of 

quinclorac or the DMA salt of quinclorac inion crops are quinclorac and its methyl ester 

metabolite for risk assessment. The residues of concern for tolerance enforcement for Rapeseed 

Subgroup 20A are parent and its methyl ester metabolite. The residue of concern for tolerance 

enforcement for all other currently registered crops is parent only. Based on previously 

submitted goat and poultry metabolism data, the residue of concern in livestock, for both 

tolerance enforcement and risk assessment, is parent only. Based on previously submitted 

environmental fate data, the residue of concern in drinking water is parent only. 

Both the acute and chronic assessments are highly conservative and incorporate 

tolerance/maximum residue level estimates based on field trial data for the residues of concern 

and assume 1 00% crop treated. Default processing factors were used and, based on empirical 

data, a processing factor of 1.5x was used for oil commodities of the Rapeseed Subgroup 20A. 

Screening-level Tier I modeling was used to estimate drinking water concentrations. 

The acute (food+ water) dietary risk estimate at the 95th percentile of exposure utilized 1.6% of 

the acute population adjusted dose (aPAD) for females age 13 to 49. This is the only population 

subgroup for which an acute endpoint was selected. 

The chronic (food + water) dietary risk estimates are less than or equal to 8.9% of the chronic 

population adjusted dose ( cP AD) for all population subgroups. All Infants < 1 year of age is the 

most highly-exposed subgroup, utilizing 8.9% of the cPAD, while the general US population 

utilizes 3.6% of the cPAD. 

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Quinclorac (PC Code 128974) Dietary Exposure and Risk Assessment DP# 406419

DMA Salt of Quinclorac (PC Code 028974) 

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Generally, the Agency is concerned when risk estimates exceed 100% of the PAD. All acute and 

chronic dietary risk estimates for quinclorac are below HED’s level of concern (LOC). 

Quinclorac was classified in 1992 by the HED Cancer Peer Review committee (CPRC) as a 

group D carcinogen - not classifiable as to human carcinogenicity- based on recommendation by 

the EPA Scientific Advisory Panel (TXR# 0010416). This classification was based on equivocal 

increase in the incidence of one type of benign tumor (pancreatic acinar cell adenomas) in only 

one sex and one species of animals (male Wistar rats). Quantification of risk using the chronic 

RfD will adequately account for all chronic effects, including carcinogenicity, that may result 

from exposure to quinclorac. There was no evidence of carcinogenicity in mice or female rats.

1. 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 which 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 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,” 21-JUN-2000, web link: 

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

AUG-1999).

The most recent dietary risk assessment for quinclorac was conducted by B. Cropp-Kohlligian

(9/24/12, DP#s 404795 and 404914).

2. Residue Information

The qualitative nature of quinclorac residues in/on crops is considered adequately understood for 

the currently registered and proposed uses, based on previously submitted rice, grain sorghum, 

and wheat metabolism studies and the newly submitted canola metabolism study. The 

qualitative nature of quinclorac residues in livestock is considered adequately understood based 

on previously submitted goat and poultry metabolism studies. In each of these studies, 

quinclorac was the major residue identified in each commodity. The methyl ester metabolite was 

reported in some grain commodities at <15% of the TRR and also identified as a major residue in 

canola seed at 37.1% of the TRR. 
Quinclorac (PC Code 128974) Dietary Exposure and Risk Assessment DP# 406419

DMA Salt of Quinclorac (PC Code 028974) 

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Based on previously submitted rice, grain sorghum, and wheat side-by-side field trial data 

comparing residue levels of quinclorac and the dimethylamine (DMA) salt of quinclorac and a 

comparative study of the dissociation behavior of quinclorac and the DMA salt of quinclorac, the 

HED risk assessment team determined that, for the existing and proposed uses under 

consideration, quinclorac and the DMA salt of quinclorac may be considered equivalent. 

Neither quinclorac nor the DMA salt of quinclorac has been considered by the HED Residues of 

Concern Knowledgebase Subcommittee (ROCKS) or any of its predecessors. Based on 

previously submitted metabolism data and the newly submitted canola metabolism data, the 

HED risk assessment team has determined that the residues of concern in plant commodities for 

risk assessment are the parent compound, quinclorac, and its methyl ester metabolite. The 

residues of concern for tolerance enforcement for Rapeseed Subgroup 20A are parent and its 

methyl ester metabolite. The residue of concern for tolerance enforcement for all other currently 

registered crops is parent only. Based on previously submitted livestock metabolism data, the 

residue of concern in livestock commodities, for both risk assessment and tolerance enforcement, 

is parent only. Based on previously submitted environmental fate data, the residue of concern in 

drinking water is parent only.

Table 1. Summary of Metabolites and Degradates to be included in the Risk Assessment and Tolerance 

Expression

Matrix Residues included in Risk 

Assessment

Residues included in 

Tolerance Expression

Plants

Rapeseed, subgroup 20A Quinclorac + its methyl ester Quinclorac + its methyl ester

Other Primary Crops Quinclorac + its methyl ester Quinclorac

Rotational Crop Quinclorac+ its methyl ester Quinclorac

Livestock

Ruminant Quinclorac Quinclorac

Poultry Quinclorac Quinclorac

Drinking Water Quinclorac Not Applicable

Previously submitted plant and livestock magnitude of the residue data were generated with data 

collection methods which included a methylation step, as do the currently acceptable 

enforcement methods. Hence, although the tolerance expression includes quinclorac only, all 

previously established tolerance levels include both quinclorac and its methyl ester metabolite

which are the residues of concern for dietary risk assessment. The newly submitted canola 

magnitude of the residue data (field and processing) were generated with data collection methods 

which determined quinclorac and its methyl ester separately.

Based on the newly submitted canola field trial data, the maximum combined residues of 

concern, parent and its methyl ester metabolite, were 1.00 ppm in/on canola seed treated at the 
Quinclorac (PC Code 128974) Dietary Exposure and Risk Assessment DP# 406419

DMA Salt of Quinclorac (PC Code 028974) 

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proposed maximum use rate. Hence, the maximum combined residues of concern in/on the raw 

agricultural commodities (RACs) of Rapeseed Subgroup 20A is estimated at 1.00 ppm. 

Based on the newly submitted canola processing data, combined residues of concern, parent and 

its methyl ester metabolite, may concentrate by 1.5x in refined canola oil. Hence, a processing 

factor of 1.5x should be applied to the oil commodities of Rapeseed Subgroup 20A to account 

for the combined residues of concern.

Under PP#2E8035, BASF Corporation is petitioning for a tolerance with no U.S. registration for 

quinclorac in/on Rapeseed Subgroup 20A for the use of the DMA salt of quinclorac in Canada

and HED is recommending the tolerance below for residues of quinclorac and its methyl ester

metabolite. 

Rapeseed Subgroup 20A..................................................................1.5 ppm

Under Registration Review of currently registered uses of quinclorac and the DMA salt of 

quinclorac, HED is recommending lowering the currently established tolerances in/on the food 

commodities below for residues of quinclorac for the purposes of harmonization. These 

recommendations have not been implemented, but HED will continue to use these lower 

tolerances in the dietary risk assessments since they are the maximum residue levels for the 

combined residues of concern.

Hog, fat .................................................................... lowered from 0.7 ppm to 0.05 ppm

Hog, meat byproducts...............................................lowered from 1.5 ppm to 0.05 ppm

Poultry, meat byproducts..........................................lowered from 0.1 ppm to 0.05 ppm

Residues in Fish

At this time, residues in fish are not deemed an important issue for quinclorac and were not 

included in the assessment. The USDA Pesticide Data Program (PDP) did not analyze for 

residues of quinclorac in catfish tested 2008-2010. No tolerances are currently established for 

residues of quinclorac in fish. However, the currently registered uses on rice and cranberry are 

aquatic crops, and HED has determined that label restrictions are needed regarding the uses of 

quinclorac-treated rice and cranberry fields for aquaculture. Alternatively, HED has suggested 

that the petitioner could determine residues of quinclorac in catfish and crayfish raised in 

quinclorac-treated fields and propose tolerances for these commodities, if necessary.

According to the Quinclorac Summary Document Registration Review: Initial Docket December 

2007, bioaccumulation in fish is not expected according to the acceptable fish accumulation 

study, which showed that after 28 days of exposure, quinclorac did not accumulate in channel 

catfish. No bioconcentration factor was reported. Furthermore, the octanol/water partition 

coefficient (KOW) of 0.266 also suggests that quinclorac has low potential to bioaccumulate. 
Quinclorac (PC Code 128974) Dietary Exposure and Risk Assessment DP# 406419

DMA Salt of Quinclorac (PC Code 028974) 

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3. Drinking Water Data

Given that the proposed new use is not domestic and that the HED quinclorac and DMA salt of 

quinclorac risk assessment team has confirmed that the residue of concern in water is parent 

only, this assessment will rely on the previous drinking water assessment.

The quinclorac drinking water estimates used in these dietary risk assessments were provided by 

EFED (DP# 397720, M. Lowit/N. Andrews, 8/9/12 and DP# 405093, M. Lowit/N.Andrews, 

9/14/12), and incorporated directly into the dietary assessments. Water residues were 

incorporated in DEEM-FCID via entry into the food categories “water, direct, all sources” and 

“water, indirect, all sources.” The estimated drinking water concentrations (EDWCs) from 

existing and proposed uses of quinclorac for both acute and chronic scenarios in ground and 

surface water are 0.029 ppm and 0.511 ppm, respectively. 

Rice (labeled for a single application of 0.5 lb a.i./A) was identified as the use resulting in the 

highest EDWCs for surface water. Because the use on rice involves flooding (for which the 

current Tier II model is not parameterized), the surface water EDWCs were assessed using a Tier 

I Rice Model, Version 1.0 (May 8, 2007). Turf grass was identified as the use resulting in the 

highest EDWCs for ground water. The EDWC in ground water was assessed using the Tier I 

Screening Concentration in Ground Water (SCI-GROW, Version 2.3) model. These models, and 

their descriptions, are available at the EPA internet website via the web link,

http://www.epa.gov/oppefed1/models/water/. No surface or ground water monitoring data were 

available for quinclorac. 

4. Percent Crop Treated Information

The acute and chronic assessments are based on the assumption that 100% of all commodities 

with tolerances will be treated.

5. DEEM-FCID Program and Consumption Information

Quinclorac acute and chronic dietary exposure assessments were conducted using the Dietary 

Exposure Evaluation Model software with the Food Commodity Intake Database DEEM-FCID, 

Version 3.16, which incorporates 2003-2008 consumption data from USDA’s National Health 

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

are based on the reported consumption of more than 20,000 individuals over two nonconsecutive 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, but for acute exposure assessment 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 
Quinclorac (PC Code 128974) Dietary Exposure and Risk Assessment DP# 406419

DMA Salt of Quinclorac (PC Code 028974) 

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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 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 acute exposure assessments, individual one-day food consumption data are used on an 

individual-by-individual basis. The reported consumption amounts of each food 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 all tiers of analysis. However, for tiers 1 and 2, any significant 

differences in user vs. per capita exposure and risk are specifically identified and noted in the 

risk assessment.

6. Toxicological Information

An appropriate endpoint attributable to a single exposure to assess dietary exposure for the 

general populations including infants and children was not available from the oral toxicity 

studies including the rat and rabbit developmental toxicity studies.

An acute dietary POD of 200 mg/kg/day (NOAEL) for the sub-population females 13-49 years 

old was selected from a rabbit developmental toxicity study based on increased rate of 

resorptions and post-implantation loss, a decrease in the number of live fetuses, and reduced fetal 

body weight seen at 600 mg/kg/day. An uncertainty factor (UF) of 100x (10x for intraspecies 

variation, 10x for interspecies extrapolation and a 1x FQPA safety factor) was applied to the 

dose to obtain an acute reference dose/population adjusted dose (aRfD/aPAD) of 2.0 mg/kg.

A chronic dietary POD of 38 mg/kg/day (NOAEL) was selected for the general population from 

a carcinogenicity study in mice based on effects on body weight. A UF of 100x (10x for 

intraspecies variation, 10x for interspecies extrapolation and a 1x FQPA factor) was applied to 

the dose to obtain a chronic reference dose/population adjusted dose (cRfD/cPAD) of 0.38

mg/kg/day.
Quinclorac (PC Code 128974) Dietary Exposure and Risk Assessment DP# 406419

DMA Salt of Quinclorac (PC Code 028974) 

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Quinclorac was classified in 1992 by the HED Cancer Peer Review committee (CPRC) as a 

group D carcinogen - not classifiable as to human carcinogenicity- based on recommendation by 

the EPA Scientific Advisory Panel (TXR# 0010416). This classification was based on equivocal 

increase in the incidence of one type of benign tumor (pancreatic acinar cell adenomas) in only 

one sex and one species of animals (male Wistar rats). Quantification of risk using the chronic 

RfD will adequately account for all chronic effects, including carcinogenicity, that may result 

from exposure to quinclorac. There was no evidence of carcinogenicity in mice or female rats.

Toxicological doses and endpoints for dietary human health risk assessments for quinclorac are 

presented below in Table 2. For detailed information, please refer to the forthcoming human 

health risk assessment. 
Quinclorac (PC Code 128974) Dietary Exposure and Risk Assessment DP# 406419

DMA Salt of Quinclorac (PC Code 028974) 

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Table 2. Summary of Quinclorac Toxicological Doses and Endpoints for Use in Dietary Human Health Risk 

Assessments.

Exposure/

Scenario

Point of 

Departure

Uncertainty/F

QPA Safety 

Factors

RfD, PAD, 

Level of 

Concern for 

Risk 

Assessment

Study and Toxicological Effects

Acute 

Dietary 

(General 

Population, 

including 

Infants and 

Children)

Not applicable. An endpoint for acute dietary exposure to the general population was not selected 

because there was no available endpoint that was appropriate for this scenario (effects observed in 

the available studies are presumed to require more than one exposure).

Acute 

Dietary

(Females 13-

49 years of 

age)

NOAEL 

(developmental) = 

200 mg/kg/day

UFA= 10x

UFH=10x

FQPA SF= 1x

aRfD = 2.0

mg/kg/day

aPAD = 2.0 

mg/kg/day

Developmental toxicity study in rabbits 

(MRID# 41063525 and 41680501) 

Developmental toxicity LOAEL = 600 

mg/kg/day based on increased early 

resorptions and post implantation loss, 

decreased live fetuses, decreased fetal 

body weight. These fetal effects are 

presumed to occur after a single dose.

Chronic 

Dietary (All 

Populations)

NOAEL= 37.5

mg/kg/day

UFA= 10x

UFH=10x

FQPA SF= 1x

cRfD = 0.38

mg/kg/day

cPAD = 0.38 

mg/kg/day

Carcinogenicity study in mice MRID # 

41063523)

LOAEL = 150 mg/kg/day based on 

decreased body weight.

Cancer (oral, 

dermal, 

inhalation)

Available carcinogenicity studies indicate that there was equivocal evidence of an increase in the 

incidence of pancreatic acinar cell adenomas in the male rat, but no treatment-associated increases 

in tumors were observed in female rats or in mice. A quantification of cancer risk is not warranted 

because the chronic RfD of 0.375 mg/kg/day is approximately 1200-fold lower than the dose (487 

mg/kg/day) that induced the benign pancreatic tumors. Thus, the chronic RfD will adequately 

account for all chronic effects, including the observed adenomas, likely to result from exposure to 

quinclorac. 

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. 
Quinclorac (PC Code 128974) Dietary Exposure and Risk Assessment DP# 406419

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7. Results/Discussion

HED is concerned when dietary risk exceeds 100% of the PAD. The DEEM-FCID analyses 

estimate the dietary exposure of the US population and various population subgroups. The 

results of the acute analysis for females 13-49 are summarized in Table 3 (below). As shown in 

Table 3, the risk estimates associated with acute dietary exposure to quinclorac are below HED’s 

LOC. 

The acute dietary risk estimate at the 95th percentile of exposure is 1.6% of the aPAD for females 

age 13 to 49. This is the only population subgroup for which an acute endpoint was selected. 

Table 3. Summary of Acute Dietary Exposure and Risk Estimates for Quinclorac Residues of Concern. 

Population Subgroup

[Years of Age]

DEEM Acute Dietary Analysis (95th Percentile)

aPAD (mg/kg/day) Exposure Estimate 

(mg/kg/day)

% aPAD

Females [13-49] 2.0 0.032207 1.6

The chronic dietary risk estimates are less than or equal to 8.9% of the chronic population

adjusted dose (cPAD) for all population subgroups as shown in Table 4 (below). All Infants 

<1year of age are the most highly-exposed subgroup, utilizing 8.9% of the cPAD, while the 

general US population utilizes 3.6% of the cPAD. 

Table 4. Summary of Chronic Dietary Exposure and Risk Estimates for Quinclorac Residues of Concern. 

Population Subgroup*

[Years of Age]

DEEM Chronic Dietary Analysis

cPAD (mg/kg/day) Exposure Estimate

(mg/kg/day)

% cPAD

General US Population 0.38 0.013768 3.6

All Infants [<1] 0.034009 8.9

Children [1-2] 0.023563 6.2

Children [3-5] 0.019358 5.1

Children [6-12] 0.013488 3.5

Youth [13-19] 0.010239 2.7

Adults [20-49] 0.013650 3.6

Adults [50-99] 0.012555 3.3

Females [13-49] 0.012935 3.4

* Values for the population subgroup with the highest risk are in bold type. 
Quinclorac (PC Code 128974) Dietary Exposure and Risk Assessment DP# 406419

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8. Characterization of Inputs/Outputs

This assessment includes all residues of concern and is based on tolerance/maximum residue 

levels in all agricultural commodities based on field trial data and assumes that 100% of all crops 

are treated at the maximum use rate. It used DEEM default processing factors and an empirical 

processing factor for oil commodities of Rapeseed Subgroup 20A. In addition, Tier I drinking 

water estimates were used. These assumptions result in highly conservative, health-protective 

estimates of dietary exposure and risk. 

9. Conclusions

Generally, the Agency is concerned when dietary risk estimates exceed 100% of the PAD. All 

acute and chronic dietary risk estimates for quinclorac are below HED’s level of concern. 

10. List of Attachments

Attachment 1. Quinclorac Residues Used for Acute and Chronic Dietary Exposure Estimates.

Attachment 2. Summary of the Acute Dietary Exposure and Risk Estimates for Quinclorac.

Attachment 3. Summary of the Chronic Dietary Exposure and Risk Estimates for Quinclorac. 
Quinclorac (PC Code 128974) Dietary Exposure and Risk Assessment DP# 406419

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Attachment 1. Quinclorac Residues Used for Acute and Chronic Dietary Exposure 

Estimates.

Filename: QUINCLORACDEEM012813INPUT.R08

Chemical: Quinclorac

RfD(Chronic): .38 mg/kg bw/day 

RfD(Acute): 2 mg/kg bw/day 

Date created/last modified: 01-14-2013/12:13:25 Program ver. 3.16, 03-08-d

Comment: Residues of concern in food for dietary risk are quinclorac plus its methyl ester 

metabolite. Currently established tolerance levels were used for all commodities except 

commodities of the Rapeseed Subgroup 20A. Currently established tolerances are based on 

magnitude of the residue data generated with a data collection method which includes a 

methylation step, so the maximum residues of the methyl ester of quinclorac, if present, are 

included in the established tolerance level. For the commodities of the Rapeseed Subgroup 20A, 

magnitude of the residue data were generated with data collection methods which determine 

quinclorac and its methyl ester separately; hence, residues in/on the seed RAC were summed to 

estimate the maximum residues of concern in/on the RACs of the Rapeseed Subgroup 20A. Based on 

canola seed processing data, residues of concern concentrate by 1.5x in the oil commodities of 

Rapeseed Subgroup 20A. DEEM default processing factors were used for cranberry juice (1.1x) and 

dried beef (1.92x).

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

 EPA Crop Def Res Adj.Factors Comment

 Code Grp Commodity Name (ppm) #1 #2 

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

1500027000 15 Barley, bran 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 

1500025000 15 Barley, pearled barley 2.000000 1.000 1.000 

1500025001 15 Barley, pearled barley-babyfood 2.000000 1.000 1.000 

3100047000 31 Beef, fat 0.700000 1.000 1.000 

3100047001 31 Beef, fat-babyfood 0.700000 1.000 1.000 

3100048000 31 Beef, kidney 1.500000 1.000 1.000 

3100049000 31 Beef, liver 1.500000 1.000 1.000 

3100049001 31 Beef, liver-babyfood 1.500000 1.000 1.000 

3100044000 31 Beef, meat 0.050000 1.000 1.000 

3100046000 31 Beef, meat byproducts 1.500000 1.000 1.000 

3100046001 31 Beef, meat byproducts-babyfood 1.500000 1.000 1.000 

3100045000 31 Beef, meat, dried 0.050000 1.920 1.000 

3100044001 31 Beef, meat-babyfood 0.050000 1.000 1.000 

1302057000 13B Blueberry 1.500000 1.000 1.000 

1302057001 13B Blueberry-babyfood 1.500000 1.000 1.000 

4000096000 40 Chicken, fat 0.050000 1.000 1.000 

4000096001 40 Chicken, fat-babyfood 0.050000 1.000 1.000 

4000094000 40 Chicken, liver 0.050000 1.000 1.000 

4000093000 40 Chicken, meat 0.050000 1.000 1.000 

4000095000 40 Chicken, meat byproducts 0.050000 1.000 1.000 

4000095001 40 Chicken, meat byproducts-babyfoo 0.050000 1.000 1.000 

4000093001 40 Chicken, meat-babyfood 0.050000 1.000 1.000 

4000097000 40 Chicken, skin 0.050000 1.000 1.000 

4000097001 40 Chicken, skin-babyfood 0.050000 1.000 1.000 

1307130000 13G Cranberry 1.500000 1.000 1.000 

1307131000 13G Cranberry, dried 1.500000 1.000 1.000 

1307132000 13G Cranberry, juice 1.500000 1.100 1.000 

1307132001 13G Cranberry, juice-babyfood 1.500000 1.100 1.000 

1307130001 13G Cranberry-babyfood 1.500000 1.000 1.000 

7000146000 70 Egg, white 0.050000 1.000 1.000 

7000146001 70 Egg, white (solids)-babyfood 0.050000 1.000 1.000 

7000145000 70 Egg, whole 0.050000 1.000 1.000 

7000145001 70 Egg, whole-babyfood 0.050000 1.000 1.000 

7000147000 70 Egg, yolk 0.050000 1.000 1.000 

7000147001 70 Egg, yolk-babyfood 0.050000 1.000 1.000 

2001163000 20A Flax seed, oil 1.000000 1.500 1.000 

3200171000 32 Goat, fat 0.700000 1.000 1.000 

3200172000 32 Goat, kidney 1.500000 1.000 1.000 

3200173000 32 Goat, liver 1.500000 1.000 1.000 
Quinclorac (PC Code 128974) Dietary Exposure and Risk Assessment DP# 406419

DMA Salt of Quinclorac (PC Code 028974) 

Page 13 of 16

3200169000 32 Goat, meat 0.050000 1.000 1.000 

3200170000 32 Goat, meat byproducts 1.500000 1.000 1.000 

3300189000 33 Horse, meat 0.050000 1.000 1.000 

3800221000 38 Meat, game 0.050000 1.000 1.000 

3600222000 36 Milk, fat 0.050000 1.000 1.000 

3600222001 36 Milk, fat-baby food/infant formu 0.050000 1.000 1.000 

3600223000 36 Milk, nonfat solids 0.050000 1.000 1.000 

3600223001 36 Milk, nonfat solids-baby food/in 0.050000 1.000 1.000 

3600225001 36 Milk, sugar (lactose)-baby food/ 0.050000 1.000 1.000 

3600224000 36 Milk, water 0.050000 1.000 1.000 

3600224001 36 Milk, water-babyfood/infant form 0.050000 1.000 1.000 

3400293000 34 Pork, fat 0.050000 1.000 1.000 

3400293001 34 Pork, fat-babyfood 0.050000 1.000 1.000 

3400294000 34 Pork, kidney 0.050000 1.000 1.000 

3400295000 34 Pork, liver 0.050000 1.000 1.000 

3400290000 34 Pork, meat 0.050000 1.000 1.000 

3400292000 34 Pork, meat byproducts 0.050000 1.000 1.000 

3400292001 34 Pork, meat byproducts-babyfood 0.050000 1.000 1.000 

3400290001 34 Pork, meat-babyfood 0.050000 1.000 1.000 

3400291000 34 Pork, skin 0.050000 1.000 1.000 

6000304000 60 Poultry, other, fat 0.050000 1.000 1.000 

6000302000 60 Poultry, other, liver 0.050000 1.000 1.000 

6000301000 60 Poultry, other, meat 0.050000 1.000 1.000 

6000303000 60 Poultry, other, meat byproducts 0.050000 1.000 1.000 

6000305000 60 Poultry, other, skin 0.050000 1.000 1.000 

3900312000 39 Rabbit, meat 0.050000 1.000 1.000 

2001319000 20A Rapeseed, oil 1.000000 1.500 1.000 

2001319001 20A Rapeseed, oil-babyfood 1.000000 1.500 1.000 

0402322000 4B Rhubarb 0.500000 1.000 1.000 

1500326000 15 Rice, bran 15.000000 1.000 1.000 

1500326001 15 Rice, bran-babyfood 15.000000 1.000 1.000 

1500324000 15 Rice, brown 5.000000 1.000 1.000 

1500324001 15 Rice, brown-babyfood 5.000000 1.000 1.000 

1500325000 15 Rice, flour 5.000000 1.000 1.000 

1500325001 15 Rice, flour-babyfood 5.000000 1.000 1.000 

1500323000 15 Rice, white 5.000000 1.000 1.000 

1500323001 15 Rice, white-babyfood 5.000000 1.000 1.000 

2001337000 20A Sesame, oil 1.000000 1.500 1.000 

2001337001 20A Sesame, oil-babyfood 1.000000 1.500 1.000 

2001336000 20A Sesame, seed 1.000000 1.000 1.000 

2001336001 20A Sesame, seed-babyfood 1.000000 1.000 1.000 

3500341000 35 Sheep, fat 0.700000 1.000 1.000 

3500341001 35 Sheep, fat-babyfood 0.700000 1.000 1.000 

3500342000 35 Sheep, kidney 1.500000 1.000 1.000 

3500343000 35 Sheep, liver 1.500000 1.000 1.000 

3500339000 35 Sheep, meat 0.050000 1.000 1.000 

3500340000 35 Sheep, meat byproducts 1.500000 1.000 1.000 

3500339001 35 Sheep, meat-babyfood 0.050000 1.000 1.000 

1500344000 15 Sorghum, grain 6.000000 1.000 1.000 

1500345000 15 Sorghum, syrup 6.000000 1.000 1.000 

1500381000 15 Triticale, flour 0.500000 1.000 1.000 

1500381001 15 Triticale, flour-babyfood 0.500000 1.000 1.000 

5000385000 50 Turkey, fat 0.050000 1.000 1.000 

5000385001 50 Turkey, fat-babyfood 0.050000 1.000 1.000 

5000383000 50 Turkey, liver 0.050000 1.000 1.000 

5000383001 50 Turkey, liver-babyfood 0.050000 1.000 1.000 

5000382000 50 Turkey, meat 0.050000 1.000 1.000 

5000384000 50 Turkey, meat byproducts 0.050000 1.000 1.000 

5000384001 50 Turkey, meat byproducts-babyfood 0.050000 1.000 1.000 

5000382001 50 Turkey, meat-babyfood 0.050000 1.000 1.000 

5000386000 50 Turkey, skin 0.050000 1.000 1.000 

5000386001 50 Turkey, skin-babyfood 0.050000 1.000 1.000 

8601000000 86A Water, direct, all sources 0.511000 1.000 1.000 

8602000000 86B Water, indirect, all sources 0.511000 1.000 1.000 

1500404000 15 Wheat, bran 0.500000 1.000 1.000 

1500402000 15 Wheat, flour 0.500000 1.000 1.000 
Quinclorac (PC Code 128974) Dietary Exposure and Risk Assessment DP# 406419

DMA Salt of Quinclorac (PC Code 028974) 

Page 14 of 16

1500402001 15 Wheat, flour-babyfood 0.500000 1.000 1.000 

1500403000 15 Wheat, germ 0.750000 1.000 1.000 

1500401000 15 Wheat, grain 0.500000 1.000 1.000 

1500401001 15 Wheat, grain-babyfood 0.500000 1.000 1.000 

1500405000 15 Wild rice 5.000000 1.000 1.000 

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Quinclorac (PC Code 128974) Dietary Exposure and Risk Assessment DP# 406419

DMA Salt of Quinclorac (PC Code 028974) 

Page 15 of 16

Attachment 2. Summary of the Acute Dietary Exposure and Risk Estimates for 

Quinclorac.

U.S. EPA Ver. 3.16, 03-08-d

DEEM-FCID ACUTE Analysis for QUINCLORAC NHANES 2003-2008 2-Day

Residue file: QUINCLORACDEEM012813INPUT.R08 Adjustment factor #2 used.

Analysis Date: 01-28-2013/13:55:55 Residue file dated: 01-28-2013/13:47:05

RAC/FF intake summed over 24 hours

Reference dose (RfD, Acute) = 2 mg/kg bw/day 

Comment: 

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

Summary calculations--per capita:

 95th Percentile 99th Percentile 99.9th Percentile

 Exposure % aRfD Exposure % aRfD Exposure % aRfD 

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

Female 13-49:

 0.032207 1.61 0.043991 2.20 0.060498 3.02 

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Quinclorac (PC Code 128974) Dietary Exposure and Risk Assessment DP# 406419

DMA Salt of Quinclorac (PC Code 028974) 

Page 16 of 16

Attachment 3. Summary of the Chronic Dietary Exposure and Risk Estimates for Quinclorac.

U.S. EPA Ver. 3.16, 03-08-d

DEEM-FCID Chronic analysis for QUINCLORAC NHANES 2003-2008 2-day

Residue file name: QUINCLORACDEEM012813INPUT.R08

 Adjustment factor #2 used.

Analysis Date 01-28-2013/13:57:25 Residue file dated: 01-28-2013/13:47:05

Reference dose (RfD, Chronic) = .38 mg/kg bw/day

Comment: 

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

 Total exposure by population subgroup

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

 Total Exposure

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

 Population mg/kg Percent of 

 Subgroup body wt/day Rfd 

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

Total US Population 0.013768 3.6%

Hispanic 0.013958 3.7%

Non-Hisp-White 0.013755 3.6%

Non-Hisp-Black 0.011721 3.1%

Non-Hisp-Other 0.018335 4.8%

Nursing Infants 0.013506 3.6%

Non-Nursing Infants 0.043167 11.4%

Female 13+ PREG 0.012459 3.3%

Children 1-6 0.020494 5.4%

Children 7-12 0.012839 3.4%

Male 13-19 0.009981 2.6%

Female 13-19/NP 0.010502 2.8%

Male 20+ 0.013121 3.5%

Female 20+/NP 0.013273 3.5%

Seniors 55+ 0.012183 3.2%

All Infants 0.034009 8.9%

Female 13-50 0.012931 3.4%

Children 1-2 0.023563 6.2%

Children 3-5 0.019358 5.1%

Children 6-12 0.013488 3.5%

Youth 13-19 0.010239 2.7%

Adults 20-49 0.013650 3.6%

Adults 50-99 0.012555 3.3%

Female 13-49 0.012935 3.4%

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