Clopy

ralid Dietary Exposure and Risk Assessment PC Code: 117401/117403 DP Number: D 399390

Page 1 of 11 **UNITED STATES ENVIRONMENTAL PROTECTION AGENCY**

**WASHINGTON, D.C. 20460 OFFICE OF**  **CHEMICAL SAFETY AND POLLUTION**  **PREVENTION MEMORANDUM**  **Date: 6**  **/ 6**  **/201 2**  **SUBJECT: Cl**  **opyra li**  **d** Chronic Aggregate Dietary (Food and Drinking Water) Exposure and Risk Assessment for the Section 3 Registration Action on Apples, Teff, the Leafy Brassica Greens Subgroup (5 - B), and the Rapeseed Subgroup (20 - A) **PC Code s**  **:** 117403 (acid)

117401 (alkanolamine salts) **DP Barcode:** D3 9 9390 **Decision No.:** 4 50262 **Registration No s**  **. :**  62719 - 73, 62719 - 80, 62719 - 81, and 62719 - 84 **Petition No.**  **:** 1E 7 882 **Regulatory Action:** Section 3 Registration **Risk Assessment Type:** Dietary **Case No.:** NA **T XR No.:**  NA **CAS No.:** 1702 - 17 - 6 (acid) 57754 - 85 - 5 (monoethanolamine salt) **MRID No.:** NA **40 CFR:** 180.431 **FROM:** Douglas Dotson, Ph.D., Chemist

Risk Assessment Branch II Health Effects Division (7509P) **THROUGH:** Meheret Negussie , Chemist

Dennis McNeill y , Chem ist Dietary Exposure Science Advisory Council (DESAC) **TO:** Laura Nollen/ Barbara Madden , RM Team 5

RI MUERB Registration Division (7505P) **Executive Summary** A c hronic dietary

(food + drinking water) exposure and risk assessment w as conducted for the herbicide clop yr alid using the Dietary Exposure Evaluation Model DEEM - FCIDTM, Version 2.03Clopy

ralid Dietary Exposure and Risk Assessment PC Code: 117401/117403 DP Number: D 399390

Page 2 of 11 which use s food consumption data from the U.S. Department of Agriculture’ s Continuing Survey s of Food Intakes by Individuals (CSFII) from 1994 - 1996 and 1998. The anal ys es were performed to support Section 3 requests for the use of clop yr alid on apples, teff, the Brassica leafy greens subgroup (Subgroup 5 - B), and the rapeseed s ubgroup (Subgroup 20 - A), except gold of pleasure. The assessment is highl y conservative with regard to protecting human health. The assessment i s based on tolerance - level residues for all commodities and the assumption that 100% of all commodities with tolerances will be treated (i.e., 100% crop treated) . In addition, DEEM (Version 7.81) default processing factors were used for all processed commodities for which they were available. Modeled estimat es of clop yralid residues in drinking water were incorporated into the analy ses. The general U.S. population uses 9.3 % of the chronic population - adjusted dose (cPAD). The population subgroup Children 1 - 2 y ears old is estimated to have the highest dietary exposure to clopyralid. This subgroup uses 2 5 % of the c PAD . Generall y, HED is concerned about dietary

risk when the exposure estimate exceeds 100% of the PAD. T he combined dietary

risk from exposure to residues of clopyralid in food and drinking water are not of concern for the U.S. population or any of the population groups. There is no acute dietary

endpoint for clopy

ralid. As a result, an acute dietary exposure assessment was not conducted for the chemical. Clopy ralid is c lassified as “ n ot likely to be carcinogenic to humans . ” As a result, quantification of cancer risk is not required. **I. Introduction**  Dietary risk assessment incorporates both exposure and toxicity of a given pesticide. For acute and chronic assessments, the risk is expressed as a percentage of a maximum acceptable dose (i.e., the dose 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 uncertaint y or safet y 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 exceed s one in one million. 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 clop yr alid was conducted b y M. Dohert y (D 36 8855 , 10/27/2009 ). **II. Residue Information**  This chronic dietary

exposure assessment is based on tolerance - level residues for all commodities. Tolerances are established for residues of clop yralid in/on a wide variet y of plant commodities at levels rang ing from 0.5 ppm in/on stone fruits and the Bushberry subgroup (13 -Clopy

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Page 3 of 11 07B) to 500 ppm in/on grass forage and hay [40 CFR §180.431(a)]. Tolerances are also established for residues of clopy ralid in livestock commodities at levels ranging from 0.1 ppm in eggs to 36 ppm in meat by products, except liver, of cattle, goats, horses and sheep . There currentl y are no tolerances for inadvertent or indirect residues of clop yralid. The residue of concern for both tolerance enforcement and risk assessment is the parent compound only . The Interregional Project No. 4 (IR - 4) submitted a petition proposing the use of clop yr alid on apples, Brassica leafy

greens (Subgroup 5 - B), and rapeseed (Subgroup 20 - A) except gold of pleasure . In addition, I R - 4 intends to submit a tolerance petition for the use of clop yr alid on teff. The only study that IR - 4 submitted in support of the current petition was a combined field trial/processing study

for apples. The recommended tolerance for apple is 0.05 ppm. For the other commodities, I R - 4 is proposing that currently established tolerances be extended to the proposed commodities. A tolerance of 5.0 ppm is established for mustard greens. IR - 4 is proposing that this tolerance be extended to the B rassica leafy greens subgroup. A tolerance of 3.0 ppm is established for canola seed. IR - 4 is proposing that this tolerance be extended to rapeseed (Subgroup 20 - A) except gold of pleasure. The following tolerances are established for wheat and barley

co mmodities: 3.0 ppm for grain, 9.0 ppm for straw, 9.0 ppm for forage (wheat only), and 9.0 ppm for hay (barley onl y). IR - 4 is proposing that these tolerances be extended to teff commodities. These requested uses do not impact existing tolerances for liv estock commodities. Table 1 provides a summary of the recommended tolerances. Table 1. Recommended Tolerances

Commodity Recommended Tolerance (ppm) Apple 0.05 Leafy Brassica Greens, Subgroup 5 - B 5.0 Rapeseed, Subgroup 20 - A, Except Gold of Pleasure 3.0 Teff, Grain 3.0 **III. Percent Crop Treated Information**  The assessment is based on the assumption that 100% of all commodities with established or proposed tolerances will be treated . **IV. Drinking Water Data**  The estimated drinking water concentrations (EDWCs) used in the dietary risk assessment were provided b y the Environmental Fate and Effects Division (EFED) in the following memorandum: “ Tier I Drinking Water Assessment for Proposed New Use of Clopyralid on Apple, L eafy

Brassica Greens Subgroup 5B, and Rapeseed Subgroup 20A, except Camelina (Gold of Pleasure) ” (D 391398 , W. Shaughness y, 12/19/2011 ) and incorporated directl y into this dietary assessment. Water residues were incorporated in the DEEM - FCID into the food categories “water, direct, all sources” and “water, indirect, all sources.”Clopy

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Page 4 of 11 A m odeled estimate of the surface water concentration fr om the FQPA Index Reservoir Screening Tool ( FIRST ) M odel w as used for the assessment (Table 2 ). This v alue is 11.9 ppb. Th is estimate is greater than th at for groundwater from the Screening Concentration in Ground Water (SCI GROW) Mo del. The same value w as used in the previous dietary exposure assessment. The drinking water models and their descriptions are available at the EPA internet site: http://www.epa.gov/oppefed1/models/water/ . **Table 2**  . **Maximum Tier 1**  **Estimated Drinking Water Concentrations** Drinking Water Source Model Used and Rate EDWC (ppb) Groundwater NAWQA (Oregon) 0.2588 Surface Water (A cute) FI RST (non - food crop, one application per year @ 0.5 lb ai/A) 45 **Surface Water (Chronic)**  FI RST (non - food crop, one application per year @ 0.5 lb ai/A) **11.9 V.**  **DEEM -**  **FCIDTM Program and Consumption Information** The c lopy ralid chronic dietary

exposure assessment w as conducted using the Dietary Exposure Evaluation Model software with the Food Commodity Intake Database DEEM - FCIDTM, Version 2.03 which incorporates consumption data from USDA’s Continuing Survey s of Food Intakes by Individuals (CSFII), 1994 - 1996 and 1998. The 1994 - 96, 98 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 o r 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 p opulation subgroups, but for acute exposure assessment are retained as individual consumption events. Based on analy sis of the 1994 - 96, 98 CSFII consumption data, which took into account dietary patterns and survey

respondents, HED concluded that it is mo st appropriate to report risk for the following population subgroups: the general U.S. population, all infants (<1 y ear old), children 1 - 2, children 3 - 5, children 6 - 12, y outh 13 - 19, adults 20 - 49, females 13 - 49, and adults 50+ y ears 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 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.Clopy

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Page 5 of 11 **VI. Toxicological Information**  The toxicology

database for clopy

ralid is incomplete at this time. Based on the toxicology data requirements outlined in the recently revised 40 CFR Part 158, there are additional requirements for acute and subchronic neurotoxicity studies in the rat (§870.6200a and b), and an immunotoxicity

study (§870.7800). In addition, a 28 - day inhalation toxicity

study in the rat (§870.3465) is required. Nevertheless, HED recommends reduction of the FQPA Safet y F actor to 1x. There was no evidence of increased pre - and/or postnatal qualitative or quantitative susceptibility

in the developmental rat or rabbit studies, or the rat 2 - generation reproduction study . In the developmental rat study , no developmental effects were seen in at a dose that caused maternal toxicity . Although acute and subchronic neurotoxicity studies and an immunotoxicity

study have not been submitted and are required under the revised 40 CFR Part 158 guidelines, the available subchronic and chronic studies show no evidence of either neurotoxicity

or immunotoxicity

at doses up to or exceeding the limit dose. The endpoints selected for risk assessment ar e therefore considered adequatel y protective of pre - and/or postnatal toxicity . The endpoints selected for use in dietary risk assessment are summarized in Table 3 , below. **Table 3**  **. Toxicological Doses and Endpoints for Clopyralid for Use in**  **Dietary Human Health Risk** 

**Assessments** Exposure/ Scenario Point of

Departure Uncertainty/FQPA

Safety Factors Level of Concern for

Risk Assessment Study and Toxicological Effects Ac ute Dietary (All populations including infants and children) NA NA NA There is no effect attributable to a single dose. As a result, an acute dietary endpoint was not selected. Chronic Dietary ( All populations including infants and children) NOAEL=

15 mg/kg/day UF A= 10x

UF H = 10x SF FQPA=1 cRfD=

0.15 mg/kg/day cPAD= 0.15 mg/kg/day 2 - Year Combined Chronic

Toxicity/Carcinogenicity (oral)

– rat LOAEL = 150 mg/kg/day, based on increased epithelial hyperplasia and thickening of the limiting ridge of the stomach in both sexes. Cancer Classified as “Not likely to be carcinogenic to hum ans . ” Quantification of cancer risk is not

required. Point of Departure = 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. UF A = extrapolation from animal to human (interspecies). UF H = potential variation in sensitivity among members of the human population (intraspecies). FQPA S F = FQPA Safety Factor. c PAD = chronic population adjusted dose . RfD = reference dose. N/A = not applicable. **V II.**  **Results** As stated above, HED is concerned when dietary risk exceeds 100% of the PAD. The DEEM FCIDTM analy ses estimate the dietary expo sure of the U.S. population and various population subgroups. The results reported in Table 4 are for the general U.S. Population, all infants (<1 ye ar old), children 1 - 2, children 3 - 5, children 6 - 12, y outh 13 - 19, females 13 - 49, adults 20 - 49,Clopy

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Page 6 of 11 and adults 5 0+ years. Risk estimates are not of concern for the general U.S. population or any of the population subgroups. The general U.S. population uses 9.3 % of the cPAD. The most highl y exposed population subgroup, Children 1 - 2 y ears old, uses 2 5 % of the cPAD. Table 4 . Summary of the Combined Dietary (Food + Drinking Water) Exposure and Risk Estimates for Clopyralid Population Subgroup Ac ute Chronic Cancer Dietary Exposure (mg/kg/day) %

aPAD* Dietary Exposure

(mg/kg/day) % cPAD* Dietary Exposure (mg/kg/day) Risk General U.S. Population

NA NA 0.013895 9.3 N/A N/A All Infants (< 1 year old) 0.013726 9.2 **Children 1 -**  **2 years old 0.03**  **7039 2**  **5** Children 3 - 5 y ears old 0.033869 23 Children 6 - 12 y ears old 0.022590 15 Youth 13 - 19 years old 0.013383 8.9 Adults 20 - 49 y ears old 0.010847 7.2 Adults 50+ years old 0.009407 6.3 Fem ales 13 - 49 y ears old 0.010170 6.8 The values for the highest exposed population subgroup are bolded . **V III.**  **Characterization of Inputs/Outputs**  HED considers the chronic dietary exposure assessment to be very conservative. It is based on tolerance - level residues for all commodities. Conservative processing factors (DEEM default) were used for all processed commodities. In add ition, it is assumed that 100% of all crops with registered or proposed will be treated. The EDWCs were also conservative. As all risk estimates are not of concern, it is not necessary to make any refinements to the dietary exposure assessment. **I X**  **. Conclusions**  The exposure estimates that were generated are very conservative estimates of the actual dietary exposures that might occur. The aggregate (food + water) dietary risk estimates are below HED’s level of concern for all population subgroups. HED is confident that the dietary exposure assessment does not underestimate risk to the general U.S. population or any population subgroup. **List of Attachments** Attachment 1. Chronic Residue Input File Attachment 2. Results of C hronic D ietary E xposur e Anal ys isClopy

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Page 7 of 11 Attachment 1: Chronic Residue Input File Chronic NO A EL : 15 mg/kg bw/day Chronic PAD : 0 .15 mg/kg bw/day DEEM - FCID Program V er sion 2.03 Filename: C: \

Documents and Settings \ddotson\My Documents \Deemfcid\ Clopy ralid\ Clopy ralidChronic 2 .R98 Date created/last modified: 03 - 02 - 2012/1 6 : 56 : 18 /8

-------------------------------------------------------------------------------- EPA Crop Def Res Adj.Factors Comment Code Grp Commodity Name (ppm) #1 #2

-------- ---- ------------------------------- ---------- ------ ------ ------- 01010500 1AB Beet, garden, roots 4.000000 1.000 1.000 01010501 1AB Beet, garden, roots - babyfood 4 .000000 1.000 1.000 01010520 1A Beet, sugar 2.000000 1 . 0 00 1.000 01010521 1A Beet, sugar - babyfood 2.000000 1 . 0 00 1.000 01010530 1A Beet, sugar, molasses 10.000000 1.000 1.000 010105 31 1A Beet, sugar, molasses - babyfood 10.000000 1.000 1.000 01013880 1AB Turnip, roots 1.000000 1.000 1.000 02000510 2 Beet, garden, tops 3.000000 1.000 1.000 04013550 4A Spinach 5.000000 1.000 1.000 04013551 4A Spinach - babyfood 5.000000 1.000 1.000 04023670 4B Swiss chard 3.000000 1.000 1.000 05010610 5A Broccoli 2.000000 1.000 1 .000 05010611 5A Broccoli - babyfood 2.000000 1.000 1.000 05010620 5A Broccoli, Chinese 2.000000 1.000 1.000 05010640 5A Brussels sprouts 2.000000 1.000 1.000 05010690 5A Cabbage 2.000000 1.000 1.000 05010710 5A Cabbage, Chinese, napa 2.000000 1.000 1.000 05010720 5A Cabbage, Chinese, mustard 2.000000 1.000 1.000 05010830 5A Cauliflower 2.0000 00 1.000 1.000 05011960 5A Kohlrabi 2.000000 1.000 1.000 05020630 5B Broccoli raab 5.000000 1.000 1.000 1E7882 05020700 5B Cabbage, Chinese, bok choy 5.000000 1.000 1.000 1E7882 05021170 5B Collards 5.000000 1.000 1.000 1E7882 05021940 5B Kale 5.000000 1.000 1.000 1E7882 05022290 5B Mustard greens 5.000000 1.000 1.000 1E7882 05023180 5B Rape greens 5.000000 1.000 1.000 1E7882 05023890 5B Turnip, greens 4 .000000 1.000 1.000 1E7882 11000070 11 Apple, fruit with peel 0.050000 1.000 1.000 1E7882 11000080 11 Apple, peeled fruit 0.050000 1.000 1.000 1E7882 11000081 11 Apple, peeled fruit - babyfood 0.050000 1.000 1.000 1E7882 11000090 11 Apple, dried 0.050000 8.000 1.000 1E7882 11000091 11 Apple, dried - babyfood 0.050000 8.000 1.000 1E7882 11000100 11 Apple, juice 0.050000 1.300 1.000 1E7882 11000101 11 Apple, juice - babyfood 0.050000 1.300 1.000 1E7882 11000110 11 Apple, sauce 0.050000 1.000 1.000 1E7882 11000111 11 Apple, sauce - babyfood 0.050000 1.000 1.000 1E7882 12000120 12 Apricot 0.500000 1.000 1.000 12000121 12 Apricot - babyfood 0.500000 1.000 1.000 12000130 12 Apricot, dried 0.500000 6.000 1.000 12000140 12 Apricot, juice 0.500000 1.000 1.000 12000141 12 Apricot, juice - babyfood 0.500000 1.000 1.000 12000900 12 Cherry 0.500000 1.000 1.000 12000901 12 Cherry - babyfood 0.500000 1.000 1.000 12000910 12 Cherry, juice 0.500000 1.500 1.000Clopy

ralid Dietary Exposure and Risk Assessment PC Code: 117401/117403 DP Number: D 399390

Page 8 of 11 12000911 12 Cherry, juice - babyfood 0.500000 1.500 1.000 12002300 12 Nectarine 0.500000 1.000 1.000 12002600 12 Peach 0.500000 1.000 1.000 12002601 12 Peach - babyfood 0.500000 1.000 1.000 1 2002610 12 Peach, dried 0.500000 7.000 1.000 12002611 12 Peach, dried - babyfood 0.500000 7 .000 1.000 12002620 12 Peach, juice 0.500000 1.000 1.000 12002621 12 Peach, juice - babyf ood 0.500000 1.000 1.000 12002850 12 Plum 0.500000 1.000 1.000 12002851 12 Plum - babyfood 0.500000 1.000 1.000 12002860 12 Plum, prune, fresh 0.500000 1.000 1.000 12002861 12 Plum, prune, fresh - babyfood 0.500000 1.000 1.000 12002870 12 Plum, prune, dried 1.500000 1.000 1.000 12002871 12 Plum, prune, dried - babyfood 1.500000 1.000 1.000 12002880 12 Pl um, prune, juice 0.500000 1.400 1.000 12002881 12 Plum, prune, juice - babyfood 0.500000 1.400 1.000 13020570 13B Blueberry 0.500000 1.000 1.000 13020571 13B Blueberry - babyfood 0.500000 1.000 1.000 13021360 13B Currant 0.500000 1.000 1.000 13021490 13B Elderberry 0.500000 1.000 1.000 13021740 13B Gooseberry 0.500000 1.000 1.000 130 21910 13B Huckleberry 0.500000 1.000 1.000 15000250 15 Barley, pearled barley 12 .000000 1.000 1.000 15000251 15 Barl ey, pearled barley - babyfood 12 .000000 1.000 1.000 15000260 15 Barley, flour 3.000000 1.000 1.000 15000261 15 Barley, flour - babyfood 3.000000 1.000 1.000 15000270 15 Barley, bran 12.000000 1.000 1.000 15001200 15 Corn, field, flour 1.000000 1.000 1.000 15001201 15 Corn, field, flour - babyfood 1.000000 1.000 1.000 15001210 15 Corn, field, meal 1.000000 1.000 1.000 15001220 15 Corn, field, bran 1.000000 1.000 1.000 15001230 15 Corn, f ield, starch 1.000000 1.000 1.000 15001231 15 Corn, field, starch - babyfood 1.000000 1.000 1.000 15001240 15 Corn, field, syrup 1.000000 1.500 1.000 15001241 15 Corn, field, syrup - babyfood 1.0 00000 1.500 1.000 15001250 15 Corn, field, oil 1.000000 1.000 1.000 15001251 15 Corn, field, oil - babyfood 1.000000 1.000 1.000 15001260 15 Corn, pop 1.000000 1.000 1.000 15001270 15 Corn, sweet 1.000000 1.000 1.000 15001271 15 Corn, sweet - babyfood 1.000000 1.000 1.000 15002310 15 Oat, bran 3.000000 1.000 1.000 15002320 15 Oat, flour 3.000000 1.000 1.000 15002321 15 Oat, flour - babyfood 3.000000 1.000 1.000 15002330 15 Oat, groats/rolled oats 3.000000 1.000 1.000 15002331 15 Oat, groats/rolle d oats - babyfood 3.000000 1.000 1.000 15003810 15 Triticale, flour 3.000000 1.000 1.000 15004010 15 Wheat, grain 3.000000 1.000 1.000 15004011 15 Wheat, grain - babyfood 3.000000 1. 000 1.000 15004020 15 Wheat, flour 3.000000 1.000 1.000 15004021 15 Wheat, flour - babyfood 3.000000 1.000 1.000 15004030 15 Wheat, germ 12.000000 1.000 1.000 15004040 15 Whea t, bran 12.000000 1.000 1.000 20001630 20 Flaxseed, oil 3.000000 1.000 1.000 1E7882 20003190 20 Rapeseed, oil 3.000000 1.000 1.000 1E7882 20003191 20 Rapeseed, oil - babyfood 3.000000 1.000 1.000 1E7882 21000440 M Beef, meat 1.000000 1.000 1.000 21000441 M Beef, meat - babyfood 1.000000 1.000 1.000 21000450 M Beef, meat, dried 1.000000 1. 920 1.000 21000460 M Beef, meat byproducts 36.000000 1.000 1.000 21000461 M Beef, meat byproducts - babyfood 36.000000 1.000 1.000 21000470 M Beef, fat 1.000000 1.000 1.000 21000471 M Beef ,fat - babyfood 1.000000 1.000 1.000 21000480 M Beef, kidney 36.000000 1.000 1.000Clopy

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Page 9 of 11 21000490 M Beef, liver 3.000000 1.000 1.000 21000491 M Beef, liver - babyfood 3.000000 1.000 1.000 23001690 M Goat, meat 1.000000 1.000 1.000 23001700 M Goat, meat byproducts 36.000000 1.000 1.000 23001710 M Goat, fat 1.000000 1.000 1.000 23001720 M Goat, kidney 36.000000 1.000 1.000 23001730 M Goat, liver 3.000000 1.000 1.000 24001890 M Horse, meat 1.000000 1.000 1.000 25002900 M Pork, meat 0.200000 1.000 1.000 25002901 M Pork, meat - babyfood 0.200000 1.000 1.000 25002910 M Pork, skin 0.200000 1.000 1.000 25002920 M Pork, meat byproducts 0.200000 1. 000 1.000 25002921 M Pork, meat byproducts - babyfood 0.200000 1.000 1.000 25002930 M Pork, fat 0.200000 1.000 1.000 25002931 M Pork, fat - babyfood 0.200000 1.000 1.000 25002940 M Pork , kidney 0.200000 1.000 1.000 25002950 M Pork, liver 0.200000 1.000 1.000 26003390 M Sheep, meat 1.000000 1.000 1.000 26003391 M Sheep, meat - babyfood 1.000000 1.000 1.000 26003400 M Sheep, meat byproducts 36.000000 1.000 1.000 26003410 M Sheep, fat 1.000000 1.000 1.000 26003411 M Sheep, fat - babyfood 1.000000 1.000 1.000 26003 420 M Sheep, kidney 36.000000 1.000 1.000 26003430 M Sheep, liver 3.000000 1.000 1.000 27002220 D Milk, fat 0.200000 1.000 1.000 27002221 D Milk, fat - baby food/ infant for 0.200000 1.000 1.000 27012230 D Milk, nonfat solids 0.200000 1.000 1.000 27012231 D Milk, nonfat solids - baby food/in 0.200000 1.000 1.000 27022240 D Milk, water 0.200000 1.000 1.000 27022241 D Milk, water - babyfood/infant form 0.200000 1.000 1.000 27032251 D Milk, sugar (lactose) - baby food/ 0.200000 1.000 1.000 40000930 P Chicken, meat 0.200000 1.000 1.000 40000931 P Chicken, meat - babyfood 0.200000 1.000 1.000 40000940 P Chicken, liver 0.200000 1.000 1.000 40000950 P Chicken, meat byproducts 0.200000 1.000 1.000 40000951 P Chicken, meat byproducts - babyfoo 0.200000 1.000 1.000 40000960 P Chicken, fat 0.200000 1.000 1.000 40000961 P Chicken, fat - babyfood 0.200000 1.000 1.000 40000970 P Chicken, skin 0.200000 1.000 1.000 40 000971 P Chicken, skin - babyfood 0.200000 1.000 1.000 50003820 P Turkey, meat 0.200000 1.000 1.000 50003821 P Turkey, meat - babyfood 0.200000 1.000 1.000 50003830 P Turkey, liver 0.200000 1.000 1.000 50003831 P Turkey, liver - babyfood 0.200000 1.000 1.000 50003840 P Turkey, meat byproducts 0.200000 1.000 1.000 50003841 P Turkey, meat byproducts - babyfood 0.200000 1.00 0 1.000 50003850 P Turkey, fat 0.200000 1.000 1.000 50003851 P Turkey, fat - babyfood 0.200000 1.000 1.000 50003860 P Turkey, skin 0.200000 1.000 1.000 50003861 P Turkey , skin - babyfood 0.200000 1.000 1.000 60003010 P Poultry, other, meat 0.200000 1.000 1.000 60003020 P Poultry, other, liver 0.200000 1.000 1.000 60003030 P Poultry, other, meat byproducts 0. 200000 1.000 1.000 60003040 P Poultry, other, fat 0.200000 1.000 1.000 60003050 P Poultry, other, skin 0.200000 1.000 1.000 70001450 P Egg, whole 0.100000 1.000 1.000 7000145 1 P Egg, whole - babyfood 0.100000 1.000 1.000 70001460 P Egg, white 0.100000 1.000 1.000 70001461 P Egg, white (solids) - babyfood 0.100000 1.000 1.000 70001470 P Egg, yolk 0.100000 1.000 1.000 70001471 P Egg, yolk - babyfood 0.100000 1.000 1.000 86010000 O Water, direct, all sources 0.011900 1.000 1.000 86020000 O Water, indirect, all sources 0.011900 1.000 1. 000Clopy

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Page 10 of 11 95000190 O Asparagus 1.000000 1.000 1.000 95001300 O Cranberry 4.000000 1.000 1.000 95001301 O Cranberry - babyfood 4.000000 1.000 1.000 95001310 O Cranberry, dried 4.000000 1 .000 1.000 95001320 O Cranberry, juice 4.000000 1.100 1.000 95001321 O Cranberry, juice - babyfood 4.000000 1.100 1.000 95001880 O Hop 5.000000 1.000 1.000 95002750 O Peppermint 3.000000 1.000 1.000 95002760 O Peppermint, oil 3.000000 1.000 1.000 95003520 O Spearmint 3.000000 1. 000 1.000 95003530 O Spearmint, oil 3.000000 1.000 1.000 95003590 O Strawberry 4.000000 1.000 1.000 95003591 O Strawberry - babyfood 4.000000 1.000 1.000 95003600 O Stra wberry, juice 4.000000 1.000 1.000 95003601 O Strawberry, juice - babyfood 4.000000 1.000 1.000Clopy

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Page 11 of 11 Attachment 2: Results of Chronic Dietary Exposure Anal ys is Chronic PAD : 0 .15 mg/kg bw/day Residue file name: C: \

Documents and Settings \ ddotson\ My Documents \Deemfcid\Clopy ralid\ Clopy ralidChronic 2 .R98 Residue file dated: 03 - 02 - 2012/1 6 : 56 : 18 /8 Analy sis Date 03 - 02 - 2012/1 6 : 57 : 23

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

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

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

-------------------------------------- ------------- --------------- U.S. Population (total) 0.013895 9.3% U.S. Population (spring season) 0.014217 9.5% U.S. Population (summer s eason) 0.013855 9.2% U.S. Population (autumn season) 0.013748 9.2% U.S. Population (winter season) 0.013769 9.2% Northeast region 0.014195 9.5% Midwest region 0.014629 9.8% Southern region 0.013132 8.8% Western region 0.014052 9.4% Hispanics 0.014065 9.4% Non - hispanic whites 0.013701 9.1% Non - hispanic blacks 0.014851 9.9% Non - hisp/non - white/non - black 0.013954 9.3% All infants (< 1 year) 0.013726 9.2% Nursing infants 0.005766 3.8% Non - nursing infants 0.016748 11.2% Children 1 - 6 yrs 0.034090 22.7% Children 7 - 12 yrs 0.021466 14.3% Females 13 - 19 (not preg or nursing) 0.011665 7.8% Females 20+ (not preg or nursing) 0.009456 6.3% Females 13 - 50 yrs 0.010835 7.2% Females 13+ (preg/not nursing) 0.011582 7.7% Females 13+ (nursing) 0.012518 8.3% Males 13 - 19 yrs 0.015007 10.0% M ales 20+ yrs 0.011198 7.5% Seniors 55+ 0.009329 6.2% Children 1 - 2 y rs 0.037039 24.7% Children 3 - 5 yrs 0.033869 22.6% Children 6 - 12 yrs 0.022590 15.1% Youth 13 - 19 yrs 0.01 3383 8.9% Adults 20 - 49 yrs 0.010847 7.2% Adults 50+ yrs 0.009407 6.3% Females 13 - 49 yrs 0.010170 6.8%

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