Quinclorac (PC Cod e 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 POLLUTIO N PREVE NT IO N



### 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 Rape seed Subgroup 20A.

PC Codes: 128974 and 028974 Decision Number: 464830 Pet ition Number: 2E8035 DP Barcode: D406419 Registration Number: Not App li cable Regulatory Action: Tolerance with No U.S. Registration Assessment Type: Single Chemical/Aggregate Case Number: 7222 TXR N umber: Not Applica ble CAS Number: 84087-0 1- 4; 84087-48-9 MRID Number: Not Applicable 40CFR 

### § 180.463

FROM: Bonnie Cropp

- Kohl l igian, Envi r onme n tal

# Scient~~**~- ~**  \

# ~ Risk Assessme nt Branch IV (RABIV), Health

## 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 Davi s, PM#25 Herbicide Branch, Registrat i on Division (7505P)

Executive Summary

Ac ut e and chronic aggregate dietary ( food and drinking water) exposure and risk assessments

were conducted using the Dietary Ex posure Evaluation Model DEEM-FCID

, Vers ion 3.16 which

uses food consumption data from the U.S. Department of Agriculture's Nationa l Health and Page 1 of 16Quinclorac (PC Code 128974) Dietary Exposure and Risk Assessment DP# 406419 DMA Salt ofQuinclorac (PC Code 028974)

Nu trition Examination Survey, What We Eat in America, (NHANES/WWEIA). Thi s dietary
survey was conducted from 2003 to 2008. These analyses were performed to s upport t he proposed tolerance with no U.S. registrat io n 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 qu i nclorac, as of the date of this memorandum, are included in th ese assessments. This memorandum was reviewed b y 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 use s under consideration, quinclorac and the DMA sa l t of quinclorac may be considered equivalent.

Neither quinclorac nor the DMA sa l t of quinclorac has been considered by the HED Residues of Concern Knowledge base Subcommittee (ROCKS) or any of its predecessors. Now, based on previously subm itted rice, grain sorghum, and wheat metabolism data and newly submitted

cano l a metaboli sm data, the HED quinclorac and DMA salt of quinclorac risk assessment team has determined that th e residues of concern for the currently registered and proposed uses of quinclorac or the DMA salt of quinclorac inion crops are quinclorac and its meth y l ester metabolite for risk assessment. The residues of concern for tolerance enforcement for Rapesee d Subgroup 20A are parent and its me thy l 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 li vestock, for both tolerance enforcement and risk assessment, is parent only. Based on previously sub mitted 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 l evel 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 modelin g was used to estima t e 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 end point was selected.

The chronic (food + water) dietary risk estimates are less than or e qual 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-expo sed s ubgroup

, utilizing 8.9% of the cPAD, while the general US population utilize s 3.6% of the cPAD.
Page 2 of 16Quinclorac (PC Code 128974) Dietary Exposure and Risk Assessment DP# 406419

DMA Salt of Quinclorac (PC Code 028974)



### Page 3 of 16 Generally, the Agency is concerned when risk estimates exceed 100% of the PAD . A ll 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

- b ased on recommendation by th e 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

. Intro duction

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 unreasona ble 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 chroni c 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 f

rom 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 r isk 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 pr oposed 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 a s 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)



### Page 4 of 16 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 stud y 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 ha s been considered by the HED Residues of Concern Knowledgebase Subcommittee (ROCKS) or any of its predecessors. B ased on previously submitted metabolism data and the newly submitted canola metabolism dat a, 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 R apeseed S ubgroup 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, t he residue of concern in livestock commodities, for both risk assessment and tolerance enforcement, is p arent only. Based on previously submitted environmental fate data, t he residue of concern in drinking water is parent only.

Table 1. Summary of Metabolites and Degradates to be includ ed 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
pr eviously 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 wit h 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 theQuinclorac (PC Code 128974) Dietary Exposure and Risk Assessment DP# 406419

DMA Salt of Quinclorac (PC Code 028974)



### Page 5 of 16 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 res id u es of concern, parent and its methyl ester metabolite, may concentrat e 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 S ubgroup 20A

................................ ................................ .. 1

. 5 ppm

Under R egist ration R eview 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 assess ments since they are the maximum residue levels for the combined residues of concern.

Hog, f at

................................ ................................ .... lowered from 0.7 ppm to 0.05 ppm Hog, m eat byproducts

................................ ............... lowered from 1.5 ppm to 0.05 ppm Poultry, m eat 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. T he USDA Pesticide Data Program (PDP) did not analyze for residues of quinclorac in catfish tested 2008

- 2010. N o tolerances are currently established for residues of quinclorac in fish . However, the currently registered use s on r ice and c ranberry are aquatic crop s , and HED has determined that label restriction s are needed regarding the use s of quinclorac

- treated rice and cranberr y fields for aquaculture. Alternatively, HED has suggested that the petitioner c ould 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, b ioaccumulation 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 chann el catfish. No bioconcentration factor was reported. Furthermore, the octanol/water partition coefficient (K OW 

### ) 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)



### Page 6 of 16 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 the se dietary risk assessment s w ere provided by EFED ( D P# 397720, M. Lowit/N. Andrews, 8/9/12 and DP# 405093, M. Lowit/N.Andrews, 9/14/12 )

, and incorporated directly into th e dietary assessment s . Water residues were incorporated in DEEM

- FCID via entry into t he food categories “water, direct, all sources” and “water, indirect, all sources.” The estimated drinking water concentration s (EDWC s ) from existing and proposed uses of quinclorac for both acute and chronic scenarios in ground and surface water are 0.0 2 9 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 involve s flooding ( for which the current Tier II model is no t 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 EDWC s 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

. Th e s e model s, and their description s, are available at the EPA internet web site 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

Q uinclorac acute and chronic dietary exposure asses sments 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 non

c onsecutive 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 fi les 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. Bas ed on analysis of the 2003

- 2008 WWEIA consumption data, which took into account dietary patterns and survey respondents, HEDQuinclorac (PC Code 128974) Dietary Exposure and Risk Assessment DP# 406419

DMA Salt of Quinclorac (PC Code 028974)



### Page 7 of 16 concluded that it is most appropriate to report risk for the following population subgroups: the general U.S. population, all infan ts (<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 food

form (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 subgrou p.

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 pest icide 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 rep orted 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
g eneral p opulations including i nfants and c hildren 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 resorption s 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 10 0x ( 1 0x for intraspecies variation, 10 x for interspecies extrapolation and a 1x FQPA safety factor ) was applied to the dose to obtain an acute reference dose / population adjusted dose ( a RfD/ a PAD) of 2.0 mg/kg

.

A chronic dietary POD of 3 8 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 10 0x ( 1 0x for intraspecies variation, 10 x 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)



### Page 8 of 16 Quinclorac was classified in 1992 by the HED Cancer Peer Review committee (CPRC) as a
g roup 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 aci nar 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 w as 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 ri sk assessment.Quinclorac (PC Code 128974) Dietary Exposure and Risk Assessment DP# 406419

DMA Salt of Quinclorac (PC Code 028974)



### Page 9 of 16 T able 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 UF A = 10x

UF H =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= 3 7.5

mg/kg/day UF A = 10x

UF H =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

- fol d 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 ob served adverse effect level. LOAEL = lowest observed adverse effect level. UF = uncertainty factor. UF A = extrapolation from animal to human (interspecies). UF H = potential variation in 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

DMA Salt of Quinclorac (PC Code 028974)



### Page 10 of 16 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 analysi s for females 13

- 49 are summarized in Table 3 (below) . As shown in Table 3 , the risk estimates associated with acute dietary exposure to q uinclorac are below HED’s LOC

.

T he acute dietary risk estimate at the 95 th 

### 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.

T able 3

. Summary of Acute Dietary Exposure and Risk Estimates for Q uinclorac Residues of Concern

. Population Subgroup [Years of Age] DEEM Acute Dietary Analysis (95 th Percentile) aPAD (mg/kg/day) Exposure Estimate (mg/kg/day) % aPAD

Females [13

- 49] 2.0 0.032 207 1.6



### The c hronic 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 <1 year of age are the most highly

- exposed subgroup, utilizing 8.9 % of the cPA D, while the general US population utilizes 3 .6 % of the cPAD.

T able 4

. Summary of Chronic Dietary Exposure and Risk Estimates for Q uinclorac 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 0.0 137 68 3 .6 All Infants [<1] 0.0 3 4009 8.9 Children [1

- 2] 0.0 235 63 6.2 Children [3

- 5] 0.0 19 358 5.1 Children [6

- 12] 0.0134 8 8 3.5 Youth [13

- 19] 0.0 10 239 2.7 Adults [20

- 49] 0.0 136 5 0 3 .6 Adults [50

- 99 ] 0.0 125 55 3 .3 Females [13

- 49] 0.0 12 93 5 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

DMA Salt of Quinclorac (PC Code 028974)



### Page 11 of 16 8

. Characterization of Inputs/Outputs

This assessment includes all residues of concern and is based on tolerance /maximum residue levels i n 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 . A ll 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

. S ummary 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

DMA Salt of Quinclorac (PC Code 028974)



### Page 12 of 16 Attachment 1. Quinclorac Residues Used for Acute and Chronic Dietary Exposure Estimates.

F ilename: 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 t he 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 inc luded 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 see d 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 process ing factors were used for cranberry juice (1.1x) and dried beef (1.9 2x)

.

----------------------------------------------------------------------------------- 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 31000490 00 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 byprod ucts 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 0.05000 0 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 400009 6001 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, wh ole

- 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 1.00 0Quinclorac (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 1.00 0 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 1.0 00 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 1.000Quinclorac (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

------------------------ -------------------------------------------------------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 Q UINCLORAC 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

-------------------------------------------------------------------------------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 Qu inclorac

.

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 Residu e 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%

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