Quinclorac (PC Code 128974) Dietary Exposure and Risk Assessment DP#s 404795 and 404914

DMA Salt of Quinclorac (PC Code 028974)

Page 1 of 14 **UNITED STATES ENVIRONMENTAL PROTECTION AGENCY**

**WASHINGTON, D.C. 20460 OFFICE OF**  **CHEMICAL SAFETY AND POLLUTION PREVENTION**  **MEMORANDUM DATE:**  **September 24 ,**  **2012 SUBJECT:**  **Quinclorac and**  **the Dimethylamine (DMA) Salt of Quinclorac**  **.** Acute and

Chronic Aggregate Dietary (Food and Drinking Water) Exposure and Risk Assessments for the Section 3 Registration Action o n Rhubarb and Low Growing Berry except Strawberry , Subgroup 13 - 07H and the Registration Review Action . **PC Code:** 128974 and 028974 **DP Barcode s:**  D404795 and D404914 **Decision Number s**  **:** 459055 and 468877 **Registration Number :**  42750 - 169 **Petition N umber**  **:** 1E7957 **Regulatory Action:** Section 3 and Registration Review **Assessment Type:** Single Chemical/Aggregate **Case N um**  **ber :**  7222 **T XR Number:**  N ot Applicable **CAS Number:** 84087 - 01 - 4 **MRID N um**  **ber :**  N ot Applicable **40CFR** §180. 463 **FROM:** Bonnie Cropp - Kohlligian, Environmental Scientist

Risk Assessment Branch IV , Health Effects Division ( HED) ( 7509P) **THROUGH:** Thurston Morton , Chemist, Senior Scientist

Risk Assessment Branch IV , H ED (7509P) and Douglas Dotson, Ph.D., Chemist Id eliz Negrón - Encarnación, Ph.D., Chemist Dietary Exposure Science Advisory Council (DESAC), HED (7509P) **TO:** S idney

Jackson and Barbara Madden, PM#5 RIMUERB, Registration Division (RD) (7505P) and Erik Kraft and Kable Davis, PM#25 Herbicide Branch, RD (7505P) and Wilhelmina L ivingston , RM#60 Pesticide Reevaluation Division (PRD) (7508P)Quinclorac (PC Code 128974) Dietary Exposure and Risk Assessment DP#s 404795 and 404914

DMA Salt of Quinclorac (PC Code 028974)

Page 2 of 14 **Executive Summary** Acute and chronic aggregate dietary ( food and drinking water) exposure and risk assessments were conducted using the Dietary Exposure Evalu ation Model DEEM - FCID, Version 3.16 which uses food consumption data from the U.S. Department of Agriculture’s National Health and Nutrition Examination Survey , What We Eat in America, (NHANES/WWEIA). This dietary survey was conducted from 2003 to 2008. These anal ys es were performed to support the Section 3 request for quinclorac use s on rhubarb and low growing berry , except strawberry , subgroup 13 - 07H and to support Re gistration R eview for quinclorac and the dimethylamine (DMA) salt of quinclorac . 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. Tolerances have been established for quinclorac (40CFR §180.463 [a] ) i n livestock and cereal grain commodities. HED has determined that the use of the DMA salt of quinclorac on cereal grains will not affect the established tolerances for quinclorac on rice, grain sorghum, and wheat. The residue of concern ( ROC ) , for both tolerance enforcement and risk assessment , is the parent compound, quinclorac . Both the acute and chronic assessments are highl y conservative, and assume 100% crop treated (%CT), along with tolerance - level residues for all agricultural commodities. Default processing factors from DEEM 7.81 were used (for dried beef and cranberry juice) in the analy ses. Screening - level Tier I modeling was used to estimate drinking water concentrations. T he acute (food + water) dietary risk estimate at the 95 th percentile of exposure is 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 c hronic (food + water) dietary risk estimates are less than or equal to 8.9 % of the chronic population adjusted dose (cPAD) 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. Generally , the Agency

is concerned whe n risk estimates exceed 100% of the PAD . A ll acute and chronic dietary

risk estimates for quinclorac are below HED’s level of concern. 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 b y th e EPA Scientific Advisory Panel (TXR# 0010416 ). This classification was based on equivocal increase in the incidence of one ty pe of benign tumor (pancreatic acinar cell adenomas) in on ly one sex and one species of animals (male Wistar rats). A quantification of cancer risk is not warranted because the chronic RfD will adequately account for all chronic effects, including the observed adenomas, likely to result from exposure to quinclorac.Quinclorac (PC Code 128974) Dietary Exposure and Risk Assessment DP#s 404795 and 404914

DMA Salt of Quinclorac (PC Code 028974)

Page 3 of 14 **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 point of departure (POD, NOAEL , LOAEL, e.g.) divided by the required uncertainty

or s afety factors. For acute and non - cancer chronic exposures, HED is concerned when estimated dietary risk exceeds 100% of the PAD. HED is generall y concerned when estimated cancer risk exceeds one in one million. References which discuss the acute and chro nic 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 W. Drew (6/2/09, DP# 363872). **2 .**  **Residue Information** Reference Memo: DP# s 397 719, 404569, 404569; 9/6/12; S. Hummel (Residue Chemistry Summary Document) Reference : Quinclorac Summary Document Registration Review: Initial Docket December 2007 (bioaccumulation) The qualitative nature of quinclorac residues in plants is considered adequately understood for the currently

registered and proposed uses, based on rice, grain sorghum, and wheat metabolism studies . The qualitative nature of quinclorac residues in livestock is considered adequatel y understood based on goat and poultry metabolism studies. Ineach of these studies, quinclorac was the major residue identified in each commodity . Ba sed on the above studies, HED has concluded that parent is the only residue of concern in plant and livestock commodities for purposes of the tolerance expression and risk assessment. Permanent t olerances have been established for quinclorac (40CFR §180.463 [a] ) in/on livestock and cereal grain commodities . A time - limited tolerance for a Section 18 emergency exemption has been established for quinclorac (40CFR §180.463[ b ]) in/in cranberry at 15.0 ppm (expiration/revocation date 12/31/12). Based on rice, grain sorghum , and wheat side - by- side field trial dat a comparing residue level s 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 , HED determined that the use of the DMA salt of quinclorac on cereal grains will not affect the established tolerances for quinclorac on rice, grain sorghum, and wheat (DP#s 378709 and 378710, J. Stokes, 3/25/11). Under PP#1 E7957 , Interregional Research Project Number 4 (IR - 4) is proposing new use s for quinclorac on rhubarb and low growing berry , except strawberry , crop subgroup 13 - 07H . InQuinclorac (PC Code 128974) Dietary Exposure and Risk Assessment DP#s 404795 and 404914

DMA Salt of Quinclorac (PC Code 028974)

Page 4 of 14 conjunction with th ese uses , HED is recommending the tolerance s below for residues of quinclorac , including its metabolites and degradates . Rhubarb ................................ ................................ ............................ 0.5 ppm Low growing berry , except strawberry , crop subgroup 13 - 07H ...... 1.5 ppm Cranberry

is the representative commodity for low growing berry , except strawberry , crop subgroup 13 - 07H. Since the proposed Section 3 use on low growing berry , except strawberry , crop subgroup 13 - 07H is essentially the same as the Section 18 use on cranberry , HED is recommending for the revocation of the currentl y established time - limited tolerance for residues of quinclorac in/on cranberry (15.0 ppm). Under Registration Review of currently registered uses of quin clorac and the DMA salt of quinclorac, HED is recommending no changes to the currently established tolerance s in/on the food commodities below for residues of quinclorac , including its metabolites and degradates . Barley , grain ................................ ................................ ..................... 2.0 ppm Rice, bran ................................ ................................ ....................... 1 5 . 0 ppm Rice, grain ................................ ................................ ........................ 5.0 ppm Sorghum, grain, grain ................................ ................................ ...... 6.0 ppm Wheat, germ ................................ ................................ ..................... 0.75 ppm Wheat, grain ................................ ................................ ..................... 0.5 ppm Egg ................................ ................................ ................................ ... 0.05 ppm Fat of Cattle, Goat, Horse, Sheep ................................ .................... 0.7 ppm Fat of Poultry ................................ ................................ ................... 0.05 ppm Meat of Cattle, Goat, Hog, Horse, Poultry , Sheep ........................... 0.05 ppm Meat by products of Cattle, Goat, Horse, Sheep ............................... 1 . 5 ppm Milk ................................ ................................ ................................ .. 0.05 ppm Under Registration Review of currently registered uses of quinclorac and the DMA salt of quinclorac, HED is recommending lowering the currentl y established tolerances in/on the food commodities below for residues of quinclorac , including its metabolites and degradates for the purposes of harmonization . Hog, f at ................................ ................................ .... lowered from 0.7 ppm to 0.05 ppm Hog, m eat by

products ................................ ............... lowered from 1.5 ppm to 0.05 ppm Poultry , m eat b yproducts ................................ .......... lowered from 0.1 ppm to 0.05 ppmQuinclorac (PC Code 128974) Dietary Exposure and Risk Assessment DP#s 404795 and 404914

DMA Salt of Quinclorac (PC Code 028974)

Page 5 of 14 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. N o tolerances are currently established for residues of quinclorac in fish . However, the currently registered

/proposed use s on rice and c ranberry are aquatic crop s , and HED has determine d that label restriction s are needed regarding the use s of quinclorac - treated rice and cranberry fields for aquaculture. Alternativel y, 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 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. **3. Drinking Water Data**  The quinclorac drinking water estimates used in the se dietary risk assessment s w ere provided by EFED ( D P# 39772 0, 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 the 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 ar e 0.0 2 9 ppm and 0.511 ppm, respectively . Rice (labeled for a single application of 0.5 lb ai/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 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 EDWC s for ground water. The EDWC in ground water was as sessed 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.Quinclorac (PC Code 128974) Dietary Exposure and Risk Assessment DP#s 404795 and 404914

DMA Salt of Quinclorac (PC Code 028974)

Page 6 of 14 **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 consumption data from USDA’s National Health and Nutrition Examination Survey , What We Eat in America, (NHANES/WWEIA). This dietary survey was conducted from 2003 to 2008. The data are based on the reported consumption of more than 20,000 individuals over two non - consecutive survey day s. 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 publicl y 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 anal ys is 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 sub groups: the general U.S. population, all infants (<1 ye ar old), children 1 - 2, children 3 - 5, children 6 - 12, youth 13 - 19, adults 20 - 49, females 13 - 49, and adults 50 - 99 ye ars 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 dail y consumption estimate for that food/food form to produce a residue intake estimate. The resulting residue intake estimate for each f ood/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 pro cedure 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 e stimate 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 e xpressed as a percentage of the aPAD on both a user (i.e., onl y 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 H ED policy , per capita exposure and risk are reported for all tiers of anal ysis. However, for tiers 1 and 2, any significant differences in user vs. per capita exposure and risk are specificall y identified and noted in the risk assessment.Quinclorac (PC Code 128974) Dietary Exposure and Risk Assessment DP#s 404795 and 404914

DMA Salt of Quinclorac (PC Code 028974)

Page 7 of 14 **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 (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 . A UF 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 ( aRfD/ aPAD) 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 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 was classified in 1992 by the HED Cancer Peer Review committe e (CPRC) as a group D carcinogen - not classifiable as to human carcinogenicity- based on recommendation b y the EPA Scientific Advisory Panel (TXR# 0010416 ). This classification was based on equivocal increase in the incidence of one ty pe of benign tumor (pancreatic acinar cell adenomas) in only one sex and one species of animals (male Wistar rats). A quantification of cancer risk is not warranted because the chronic RfD will adequately account for all chronic effects, including the observed adenomas, likely to result from exposure to quinclorac. There was no evidence o f carcinogenicity

in mice or female rats . Toxicological doses and endpoints for dietary human health risk assessments for quinclorac are presented below in Table 1. For detailed information, please refer to the forthcoming human health risk assessment.Quinclorac (PC Code 128974) Dietary Exposure and Risk Assessment DP#s 404795 and 404914

DMA Salt of Quinclorac (PC Code 028974)

Page 8 of 14 **T ABLE**  **1. Summary of Quinclorac Toxicological Doses and Endpoints for Use in Dietary Hum**  **an 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)**  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**  **(Fem ales 13**  **- 49 years of**  **age)** NOAEL

(develo pmental) = 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 postimplantation 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, derm**  **al, 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 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#s 404795 and 404914

DMA Salt of Quinclorac (PC Code 028974)

Page 9 of 14 **7 .**  **Results/Discussion** HED is concerned when dietary risk exceeds 100% of the PAD. The DEEM - FCID anal ys es estimate the dietary exposure of the US population and various population subgroups. The results of the acute anal ysi s for females 13 - 49 are summarized in Table 2 (below) . As shown in Table 2 , the risk estimates associated with acute dietary exposure to quinclorac 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. **TABLE 2 .**  **Summary of Acute Dietary Exposure**  **and Risk Estim ates for Q**  **uinclorac .**  **Population Subgroup [Years of Age]**  **DEEM Acute Dietary Analysis (95**  **th Percentile)**  **aPAD (m g/kg/day)**  **Exposure Estimate (m**  **g/kg/day) % aPAD**  **Fem ales [13**  **- 49]**  **2.0 0.032108**  **1.6** ***** NA = Not Applicable . An appropriate acute endpoint was not identified for these population subgroups. 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 3 (below). All Infants <1 ye ar 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 3**  **. Summary of Chronic Dietary Exposure and Risk Estimates for**  **Q uinclorac**  **. Population**  **Subgroup*** **[Years of Age] DEEM**  **Chronic Dietary Analysis**  **cPAD (m g/kg/day)**  **Exposure Estimate**  **(m g/kg/day)**  **% cPAD** General US Population 0.38 0.0 13728 3 .6 **All Infants [<1] 0.0**  **33999 8.9**  Children [1 - 2] 0.0 23500 6.2 Children [3 - 5] 0.0 19280 5.1 Children [6 - 12] 0.013431 3.5 Youth [13 - 19] 0.0 10195 2.7 Adults [20 - 49] 0.0 13614 3 .6 Adults [50 - 99 ] 0.0 12525 3 .3 Females [13 - 49] 0.0 12893 3 .4 ***** Values for the population subgroup with the highest risk are in **bold** ty pe .Quinclorac (PC Code 128974) Dietary Exposure and Risk Assessment DP#s 404795 and 404914

DMA Salt of Quinclorac (PC Code 028974)

Page 10 of 14 **8 .**  **Characterization of Inputs/Outputs**  This assessment is based on tolerance level residues in all agricultural commodities , assumes that all crops with existing or proposed tolerances are treated to a level of 100% and makes use of DEEM default processing factors . 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#s 404795 and 404914

DMA Salt of Quinclorac (PC Code 028974)

Page 11 of 14 **Attachment 1. Quinclorac**  **Residues Used for Acute and Chronic**  **Dietary Exposure Estimates.**  U.S. EPA Ver. 3.16, 03 - 08 - d DEEM - FCID Acute and Chronic analysis for QUINCLORAC Residue file name : QUINCLORACDEEM092412INPUT.R08 Adjust. #2 used Analysis Date 09 - 24 - 2012 Residue file dated: 09 - 24 - 2012/10:44:12 Acute Reference dose (RfD) = 2.0 mg/kg bw/day (Females 13 - 49 only) Chronic Reference dose (RfD) = 0.38 mg/kg bw/day Comment: Tolerances Used for Acute and Chronic Analyses

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

---------- ---- ------------------------------- -------- -- ------ ------ 1500025000 15 Barley, pearled barley 2.000000 1.000 1.000 1500025001 15 Barley, pearled barley - babyfood 2.000000 1.000 1.000 1500026000 15 Barley, flour 2.000000 1.000 1.000 1500026001 15 Barley, flour - babyfood 2.000000 1.000 1.000 1500027000 15 Barley, bran 2.000000 1.000 1.000 3100044000 31 Beef, meat 0.050000 1.000 1.000 3100044001 31 Beef, meat - babyfood 0.050000 1.000 1.000 3100045000 31 Beef, meat, dried 0.050000 1.920 1.000 3100046000 31 Beef, meat byproducts 1.500000 1.000 1.000 310004600 1 31 Beef, meat byproducts - babyfood 1.500000 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 Bee f, 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 1302057000 13B Blueberry 1.500000 1.000 1.000 1302057001 13B Blueberry - babyfood 1.500000 1.000 1.000 4000093000 40 Chicken, meat 0.050000 1.000 1.000 4000093001 40 Chicken, meat - babyf ood 0.050000 1.000 1.000 4000094000 40 Chicken, liver 0.050000 1.000 1.000 4000095000 40 Chicken, meat byproducts 0.050000 1.000 1.000 4000095001 40 Chicken, meat byproducts - baby foo 0.050000 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 4000097000 40 Chicken, skin 0.05 0000 1.000 1.000 4000097001 40 Chicken, skin - babyfood 0.050000 1.000 1.000 1307130000 13G Cranberry 1.500000 1.000 1.000 1307130001 13G Cranberry - babyfood 1.500000 1.0 00 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 7000145000 70 Egg, whole 0.050000 1.000 1.000 7000145001 70 Egg, whole - babyfood 0.050000 1.000 1.000 7000146000 70 Egg, white 0.050000 1.000 1.000 700 0146001 70 Egg, white (solids) - 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 3200169000 32 Goat, meat 0.050000 1.000 1.000 3200170000 32 Goat, meat byproducts 1.500000 1.000 1.000 3200171000 32 Goat, fat 0.700000 1.000 1.000 3200172000 32 Goat, k idney 1.500000 1.000 1.000 3200173000 32 Goat, liver 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 3600224000 36 Milk, water 0.050000 1.000 1.000 3600224001 36 Milk , water - babyfood/infant form 0.050000 1.000 1.000Quinclorac (PC Code 128974) Dietary Exposure and Risk Assessment DP#s 404795 and 404914

DMA Salt of Quinclorac (PC Code 028974)

Page 12 of 14 3600225001 36 Milk, sugar (lactose) - baby food/ 0.050000 1.000 1.000 3400290000 34 Pork, meat 0.050000 1.000 1.000 3400290001 34 Pork, meat - bab yfood 0.050000 1.000 1.000 3400291000 34 Pork, skin 0.050000 1.000 1.000 3400292000 34 Pork, meat byproducts 0.050000 1.000 1.000 3400292001 34 Pork, meat byproducts - ba byfood 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 6000301000 60 Poultry, other, meat 0.050000 1.000 1.000 6000302000 60 Poultry, other, liver 0.050000 1.000 1.000 6000303000 60 Poultry, other, meat byproducts 0.050000 1.000 1.000 6000304000 60 Poultry, other, fat 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 0402322000 4B Rhubarb 0.500000 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 1500324000 15 Rice, brown 5.000000 1.000 1.000 1500324001 15 Rice, brown - babyfood 5.000000 1.000 1.000 15003250 00 15 Rice, flour 5.000000 1.000 1.000 1500325001 15 Rice, flour - babyfood 5.000000 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 3500339000 35 Sheep, meat 0.050000 1.000 1.000 3500339001 35 Sheep, meat - babyfood 0.050000 1.000 1.000 3500340000 35 Sheep, mea t byproducts 1.500000 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 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 5000382000 50 Turkey, meat 0.050 000 1.000 1.000 5000382001 50 Turkey, meat - babyfood 0.050000 1.000 1.000 5000383000 50 Turkey, liver 0.050000 1.000 1.000 5000383001 50 Turkey, liver - babyfood 0.050000 1.00 0 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 5000385000 50 Turkey, fat 0.050000 1.000 1.0 00 5000385001 50 Turkey, fat - 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 8601 000000 86A Water, direct, all sources 0.511000 1.000 1.000 8602000000 86B Water, indirect, all sources 0.511000 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 1500402000 15 Wheat, flour 0.500000 1.000 1.000 1500402001 15 Wheat, flour - babyfood 0.500000 1.000 1.000 1500403000 15 Wheat, germ 0.750000 1.000 1.000 1500404000 15 Wheat, bran 0.500000 1.000 1.000 1500405000 15 Wild rice 5.000000 1.000 1.000Quinclorac (PC Code 128974) Dietary Exposure and Risk Assessment DP#s 404795 and 404914

DMA Salt of Quinclorac (PC Code 028974)

Page 13 of 14 **Attachme nt 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 na me : QUINCLORACDEEM092412INPUT.R08 Adjustment factor #2 used. Analysis Date: 09 - 24 - 2012/10:46:50 Residue file dated: 09 - 24 - 2012/10:44:12 RAC/FF intake summed over 24 hours Run Comment: Acute is for Females 13 - 49 only.

========================== ===================================================== Summary calculations -- per capita: 95th Percentile 99th Percentile 99.9th Percentile Exposure % aRfD Exposure % aRfD Exposure % aRfD

---------- -------- ---------- -------- ---------- -------- Female 13 - 49: 0.032108 1.61 0.043819 2.19 0.060306 3.02Quinclorac (PC Code 128974) Dietary Exposure and Risk Assessment DP#s 404795 and 404914

DMA Salt of Quinclorac (PC Code 028974)

Page 14 of 14 **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: Q UINCLORACDEEM092412INPUT.R08 Adjustment factor #2 used. Analysis Date 09 - 24 - 2012/10:45:30 Residue file dated: 09 - 24 - 2012/10:44:12 Reference dose (RfD, Chronic) = .38 mg/kg bw/day COMMENT 1:

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

------------------------------------------------------------------------------- Total Exposure

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

-------------------------------------- ------------- - --------------- Total US Population 0.013728 3.6% Hispanic 0.013922 3.7% Non - Hisp - White 0.013714 3.6% Non - Hisp - Black 0.011683 3.1% Non - Hisp - Other 0.018298 4.8% Nursing Infants 0.013500 3.6% Non - Nursing Infants 0.043154 11.4% Female 13+ PREG 0.012415 3.3% Children 1 - 6 0.020422 5.4% Children 7 - 12 0.012785 3.4% Male 13 - 19 0.009941 2.6% Female 13 - 19/NP 0.010453 2.8% Male 20+ 0.013090 3.4% Female 20+/NP 0. 013237 3.5% Seniors 55+ 0.012155 3.2% All Infants 0.033999 8.9% Female 13 - 50 0.012889 3.4% Childr en 1 - 2 0.023500 6.2% Children 3 - 5 0.019280 5.1% Children 6 - 12 0.013431 3.5% Youth 13 - 19 0.010195 2.7% Adults 20 - 49 0.013614 3.6% Adults 50 - 99 0.012525 3.3% Female 13 - 49 0.012893 3.4%

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