Tolfenpyrad Dietary Exposure and Risk Assessment DP Number: D398817

PC Code: 090111



### Page 1 of 18



### UNITED STA**TES ENVIRONMENTA L PROTECTION A** **GENCY**

**WA SHINGTON, D.C. 20460**  **OFFICE OF CHEMICAL SAFETY AND POLLUTION PREVENTION** 



### MEMORANDUM **Date:** 6 February 2012 **SUBJECT: Tolfenpyrad**  Acute and Chronic Aggregate Dietary Exposure and Risk Assessments PC Code: 090111 DP Barcode: D398817 Decision No.: 440578 Registration No. : 71711 - 31, 71711 - GA Petition No.: 0F7791 Regulatory Action: Section 3 Assessment Type: Single Chemical Registration Case No.: NA T XR No.: None CAS No.: 129558 - 76 - 5 MRID No s .: None 40 CFR 180. none (first food use request) 

### FROM **:** Michael A. Doherty, Ph.D., Senior Chemist

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

Julie VanAlstine, Environmental Health Scientist Dietary Exposure Science Advisory Council (DESAC) Health Effects Division (7509P) Christina Swartz, Branch Chief Risk Assessment Branch II Health Effects Division (7509P) **TO:** Michael A. Doherty, Ph.D., Senior Chemist

Risk Assessment Branch II Health Effects Division (7509P) Dris s B enmhend/Mark Suarez (Team 13) Insecticide Branch Registration Division (7505P)Tolfenpyrad Dietary Exposure and Risk Assessment DP Number: D398817

PC Code: 090111



### Page 2 of 18 

### Exe **cutive Summary** Acute and chronic aggregate dietary (food and drinking water) exposure and risk assessments were conducted using the Dietary Exposure Evaluation Model DEEM - FCIDTM (v. 2.03). This model uses food consumption data from the U.S. Department of Agriculture’s (USDA’s) Continuing Survey s of Food Intakes by Individuals (CSFII) from 1994 - 1996 and 1998. The anal ys es were performed to support a Section 3 registration request on the following fourteen crops or crop groups: potato; leafy vegetables, except Brassica ; Brassica leafy vegetables; fruiting vegetables; cucurbit vegetables; citrus fruits; pome fruits; stone fruits ; persimmon ; pomegranate; grape; tree nuts (including pistachio ) ; cotton; and tea . A quantitative cance r assessment was not conducted. Tolfenp yr ad is classified as “not likely to be carcinogenic to humans;” therefore, there is no cancer risk associated with tolfenpy rad. The acute assessment is a screening - level, highly conservative assessment. Inputs to the anal ys is are tolerance - level residues for the above - listed foods and modeled estimates of residues in drinking water. The acute assessment assumes that all crops with proposed uses are treated (i.e., 100% crop treated). For the acute assessment, the highest estimated exposure at the 95 th 

### percentile is 0.076 mg/kg/day , which corresponds to 76 % of the aPAD . Ty pically HED has concerns when exposures exceed 100% of the acute or chronic population - adjusted dose (aPAD or cPAD). Acute dietary risk estimate s are below HED’s level of concern for all population subgroups. The chronic assessment is significantl y refined. Inputs to the chronic assessment include average residue levels from crop field trials ; use of percent crop treated estimates for foods which were shown to have a high contribution to the overall dietary exposure ; liberal translation of juice processing factors; and reduction of residues from removal of head lettuce and cabbage wrapper leaves . Although refined, the chronic dietary analysi s is not expected to underestimate dietary exposures. The highest chronic dietary exposure estimate is 0.004 1 mg/kg/day , which corresponds to 6 9 % of the cPAD. As with the acute assessment, the chronic estimates are below HED’s level of concern for all population subgroups. There are no dietary

exposure considerations that would preclude granting the requested uses of tolfenpy rad. **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 eq uivalent to point of departure (POD, NOAEL , LOAEL, e.g.) divided by the required uncertainty

or safety factors. For acute and non - cancer chronic exposures, HED is concerned when estimated dietary risk exceeds 100% of the PAD. HED is generall y concerned when estimated cancer risk exceeds 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 ExposureTolfenpyrad Dietary Exposure and Risk Assessment DP Number: D398817

PC Code: 090111



### Page 3 of 18 

### 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). This is the first food - use assessment for tolfenp yr ad . **II. Residue Information**  The Agency

has received a petition requesting use of tolfenpy rad on a large number of crops. This is the first food - use petition for this chemical. As such, there are no tolerance entries for tolfenpy rad in the Code of Federal Regulation (CFR) at this time. The toxicological and residue chemistry databases for tolfenpy

rad have been examined to determine residue definitions for tolerance - setting and risk - assessment purposes. The residue definitions are summarized in Table 1 and are in keeping with the recommendations of the Residues of Concern Knowledgebase Subcommittee (ROCKS; D395592, 18 January 2012). Table 1. Residue Definitions for Tolfenpyrad. Matrix Risk Assessment Tolerance Expression Plants Primary Crop Tolfenpyrad + PT - CA 1 (root crops only) Tolfenpyrad

Rotational Crop -- 2

-- Livestock Ruminant Tolfenpyrad + PT - CA + OH - PT - CA 3 Tolfenpyrad + PT - CA

Poultry Tolfenpyrad + PT - CA + PCA Tolfenpyrad + PT - CA Drinking Water Tolfenpyrad + PT - CA + PCA + PAM + PT(A) - 4 - OH Not Applicable 1 The metabolite abbreviations used here (i.e. "PCA" and "PAM") are specific for the metabolites depicted in the residue chemistry summary document ( M. Doherty, D384995, 12 April 2012 ). These abbreviations are not intended to represent other chemicals with similar, but not identical, structures using similar abbreviations. 2 Residues of concern in rotational crops are not expected as a result of the proposed use patterns. 3 OH - PT - CA should be limited to ruminant liver, kidney , and other meat byproducts. 

### The crop field trials and cattle feeding study did not measure all of the residues of concern for risk assessment purposes. Therefore, residues of PT - CA in root crops and residues of OH - PT CA in ruminant liver, kidney , and oth er meat b yproducts are accounted for by using ratios of these residues relative to the measured residues (parent in crops, parent + PT - CA in cattle) from the crop and livestock metabolism studies. Inthe crop metabolism studies, radish root is representative of root crops. Residues of tolfenpyrad in radish root accounted for 54% of the total radioactive residue (TRR); residues of PT - CA in this commodity accounted for 22% of the TRR. Therefore, the relative ratio of PT - CA to tolfenpy rad is 0.41. A factor of 1.41 has been used in the input files (Attachments 1 and 2) to convert tolfenp yrad to tolfenpy rad + PT - CA for potato commodities (the only root crop in the current request) . Similarl y, in the goat metabolism study , tolfenp yr ad + PT - CA account for 59% TRR and 63% TRR in liver and kidney , respectivel y. The metabolite OH - PT - CA made up 28% TRR and 19% TRR in these tissues, giving ratios of 0.47 in liver and 0.30 in kidney . A factor of 1.47, incorporating the greater of these two ratios, was used for all livestock liver, kidney , and meat - by product entries in the assessments. Acute Assessment : With the exception of juices, the acute assessment assumes tolerance - level residues in all crops with requested uses (i.e., 100% crop treated). Also with the excep tion ofTolfenpyrad Dietary Exposure and Risk Assessment DP Number: D398817

PC Code: 090111



### Page 4 of 18 

### juices, default processing factors from DEEM 7. 81 were used for processed commodities when empirical data were not available. For juices, a processing factor of 0.03 was used unless a lower empirical value was available for a particular juice. Th e factor of 0.03 is from the processing of grapes into grape juice and is the maximum juice factor in the tolfenp yr ad database. Even with this refinement, the acute assessment should be considered a screening - level assessment and very conservative with re spect to protecting human health. Chronic Assessment : While still protective of human health, the chronic assessment incorporates three refinements that are not used in the acute assessment. First, the chronic assessment uses averag e values (Table 2 ) from crop field trials. For crop group commodities, a standard procedure 1 

### was used to parse residue data from representative crops to other crops in the crop group. Second , the chronic assessment incorporates new - use percent crop treated estimates (PCTn) for oranges, apples, table grapes, and spinach (Table 3 ). These estimates were provided by the Biological and Economic Analysis Division ( S. Haddad, D 393941, 6 February 2012 ). Third , the chronic assessment includes a factor of 0.08 to reflect the reduction in residues for cabbage and head lettuce when the wrapper leaves are removed prior to marketing and consumption. The chronic assessment uses the same processing factors as those described for the acute assessment. Table 2. Summary of Crop Field Trial Residue Data. Commodity Residue, ppm Translated to Tolerance Mean Potato (Input file includes factor of 1.41 to account for PT - CA metabolite) Potato Tuber 0.01 0.01 -- Potato Processed Commodities (Processing Factor = 1) -- 0.01 -- Leafy Vegetables Crop Group 4 Leaf Lettuce 30 5.45 -- Head Lettuce (w

/ wrapper leaves) 30 1.59 -- Celery 30 2.71 Cardoon, Celtuce, Florence Fennel, Rhubarb , Swiss Chard Spinach 30 9.88 Head and Stem Brassica Vegetables Crop Subgroup 5A Cauliflower 5 0.199 Broccoli, Chinese Broccoli , Chinese Mustard Cabbage Cabbage w/ wrapper leaves 5 1.43 Brussels Sprouts, Chinese Napa Cabbage, Kohlrabi Leafy Brassica Vegetables Crop Subgroup 5B Mustard Greens 40 8.62 Broccoli Raab, Bok Choy, Collards, Kale, Rape Greens, Turnip Greens Fruiting Vegetables Crop Group 8 - 10 Tomato 0.7 0.124 Groundcherry, Pepino, Tomatillo , Tree Tomato Tomato Puree (Processing Factor = 0.3) -- 0.124 -- Tomato Paste (Processing Factor = 1.02) -- 0.124 -- Bell Pepper 0.7 0.09 Eggplant Non -bell Pepper 0.7 0.233 Okra Cucurbit Vegetables Crop Group 9 1 HED SOP 2000.1: Guidance for Translation of Field Trial Data from Representative Commodities in the Crop Group Regulation to Other Commodities in Each Crop Group/Subgroup (9/12/2000) .Tolfenpyrad Dietary Exposure and Risk Assessment DP Number: D398817

PC Code: 090111



### Page 5 of 18 Table 2. Summary of Crop Field Trial Residue Data. Commodity Residue, ppm Translated to Tolerance Mean Cucumber 0.7 0.12 Waxgourd, Balsam Pear, Bitter Melon Cantaloupe 0.7 0.23 Citron Melon, Watermelon , Casaba, Honeydew Melon Summer Squash 0.7 0.047 Pum pkin, Winter Squash, Chayote Citrus Fruits Crop Group 10 - 10 Orange 1.5 0.409 Citrus Citron, Tangerine , Kumquat Grapefruit 1.5 0.217 Pummelo Lemon 1.5 0.437 Lime Orange Juice (Processing Factor = 0.02) -- See Above Grapefruit Juice, Lemon Juice,

Lime Juice, Tangerine Juice Citrus Oil (Processing Factor = 82) 70 0.409 -- Pome Fruits Crop Group 11 - 10 Apple 0.7 0.206 Crabapple Apple Juice (Processing Factor = <0.01) -- 0.206 Processing factor applied to pear juice Pear 0.7 0.199 Loquat, Quince Stone Fruit Crop Group 12 Sweet Cherry 2 0.551 Persimmon, Pomegranate Peach 2 0.362 Apricot, Nectarine Plum 2 0.402 -- Plum, Dried (Processing Factor = 2.9) 3 0.402 -- Tree Nuts Crop Group 14 Almond Nutmeat 0.05 0.013 Chestnut, Pistachio Pecan Nutmeat 0.05 0.01 Brazil Nut, Butternut, Cashew, Filbert, Hickory Nut, Macadamia Nut, Walnut Other Cotton, Undelinted Seed 0.7 0.172 -- Cotton, refined oil (Processing Factor = 0.05) -- 0.172 -- Grape 2 0.53 -- Grape Juice (Processing Factor = 0.03) -- 0.53 Processing factor applied to all juices not otherwise listed. Grape, Raisins (Processing Factor = 3.7) 6 0.53 -- Tea 30 7.06 -- Livestock (Cattle, Horses, Goats, and Sheep; Input file includes factor of 1.47 to account for OH - PT - CA metabolite in kidney, liver, and meat by products) Meat 0.01 -- -- Fat 0.01 -- -- Kidney 0.35 -- -- Liver 0.35 -- -- Meat Byproducts 0.35 -- -- Milk 0.03 -- -- Table 3 . PCTn for Tolfenpyrad Based on Insecticide Market Leaders . From S. Haddad, D 393941, 6 February 2012 Crop Year Market Leader Percent Crop Treated PCTn for Tolfenpyrad*

Chronic (Avg.) Ac ute (Max.) Oranges 2009 Petroleum Distillate 62% 40 60Tolfenpyrad Dietary Exposure and Risk Assessment DP Number: D398817

PC Code: 090111



### Page 6 of 18

2005 Spinosad 32% 2003 S - methoprene 17% Apples 2009 Carbaryl 51% 60 65

2007 Azinphos - methyl 62% 2005 Azinphos - methyl 63% Table Grapes 2010 Proprietary Proprietary 65 90

2009 2008 2007 2006 2005 Spinach 2010 Permethrin 53% 50 55

2006 Spinosad 47% 2004 Spinosad 49% * all numbers rounded Source : USDA NASS Agricultural Chemical Usage - Fruit Summary (2003, 2005, 2007, 2009), Vegetable Summary (2004, 2006, 2010) 

### III. **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: “ Drinking Water Exposure Assessment for Proposed New Uses of Tolfenpy rad on a Variety of Agricultural Crops, Nurseries, an d Christmas Trees ” ( L. Liu , D 383822 , 23 January 2012 ) and incorporated directly 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.” The drinking water assessment notes that b ased on the submitted environmental fate data and reported phys ical - chemical properties, tolfenpy rad and its transformation products are expected to moderatel y degrade in the environment. In soil, tolfenpyrad is expected to be essentiall y immobile ; however, the degradates PCA and PT - CA are expected to be highl y mobile . A total residue approach was used to model residues in drinking water, with the residues of concern being PCA, PT - CA, PT(A) - 4OH, and PAM . Tolfenp yrad was modeled in this assessment as stable to metabolism and degradation because only limited studies were submitted by the registrant. As a result, the metabolic half - lives used in modeling were multiplied by 3. If additional metabolism studie s become av ailable, EECs could be lowered. Assessment modeling relied on maximum labeled use patterns and a default national percent cropped area value (87%) . Where actual use patterns are less than the labeled maximum and location - specific PCAs are less than assumed in this assessment, actual environmental exposures may be lower. Drinking water exposure estimates for the proposed uses of tolfenp yr ad are represented by the use pattern of maximum tolfenpy rad exposure, nurseries and Christmas trees ( Table 4 ). Maximum acute, chronic, and cancer EDWCs in surface water are 2 6.9 , 1 2.2 , and 4.8 μg/L, respectivel y. The maximum exposure estimate for ground water is 11 μg/L . Monitoring and drinking water treatment data on tolfenp yr ad are not available . The model and its description are available at the EPA internet site: http://www.epa.gov/oppefed1/models/water/ .Tolfenpyrad Dietary Exposure and Risk Assessment DP Number: D398817

PC Code: 090111



### Page 7 of 18 Table 4 . Tolfenpyrad EDWCs in Surface Water and Ground Water for Use in Dietary Ri sk Assessment Based on the Use Pattern of Maximum Exposure, Nurseries and Christmas Trees. * Use (maximum rate) Source Cropped Area, % 1 - in - 10 - year

Peak (Acute) Conc., ppb 1 - in - 10 - year Annual

Mean (Chronic) Conc., ppb 30 - year Daily

Average (Cancer) Conc., ppb Ornamental plants and Christmas trees (2.72 lbs a.i./A/year) Surface water 87 26.9 12.2 4.8 Ornamental plants and Christmas trees (2.72 lbs a.i./A/year) Ground water N/A 11.0

* EDWCs were calculated based on total residues of concern (a summation of tolfenpyrad, PAM, PT - CA, PCA and PT(A) - 4OH) and a percent cropped area of 87%. 

### IV. **DEEM -**  **FCIDTM Program and Consumption Information** Tolfenp yrad acute and chronic dietary exposure assessments were 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 b y 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 days. Foods “as consumed” (e.g., apple pie) are linked to EPA - defined food comm odities (e.g. , apples, peeled fruit - cooked; fresh or N/S; baked; or wheat flour - cooked; fresh or N/S, baked) using publicly

available recipe translation files developed jointly by USDA/ARS and EPA. For chronic exposure assessment, consumption data are averaged for the entire U.S. population and within population subgroups, but for acute exposure assessment are retained as individual consumption events. Based on anal ys is of the 1994 - 96, 98 CSFII consumption data, which took into account dietary

pattern s and survey

respondents, HED concluded that it is most appropriate to report risk for the following population subgroups: the general U.S. population, all infants (<1 ye ar old), children 1 - 2, children 3 - 5, children 6 - 12, youth 13 - 19, adults 20 - 49, females 13 - 49, and adults 50+ 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 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. For acute exposure assessments, individual one - day food consumption data are used on an indiv idual - by- individual basis. The reported consumption amounts of each food item can be multiplied by

a residue point estimate and summed to obtain a total daily pesticide exposure for a deterministic exposure assessment, or “matched” in multiple random pairings with residue values and then summed in a probabilistic assessment. The resulting distribution of exposures is expressed as a percentage of the aPAD on both a user (i.e., onl y those who reported eating relevant commodities/food forms) and a per- capita (i.e., those who reported eating the relevantTolfenpyrad Dietary Exposure and Risk Assessment DP Number: D398817

PC Code: 090111



### Page 8 of 18 

### commodities as well as those who did not) basis. In accordance with HED policy, per capita exposure and risk are reported for all tiers of 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. **V. Toxicological Information**  A variety of toxic effects were noted in the toxicology database for tolfenp yrad ; h owever, the most consistent finding across species and studies was effects on body weight and body

weight gain. Decreases in body

weight and/or body

weight gain were observed in adults of all species (rat, mice, rabbit, and dog) in the majority of the subchronic oral and dermal toxicity studies, and all chronic toxicity

studies. The toxicological database is complete for the purpose of FQPA assessment. Additionally, there are no concerns for increased quantitative and qualitative susceptibility or residual uncertainties for pre - and postnatal toxicity . Although increased qualitative susceptibility was seen in the yo ung in the developmental immunotoxicity study (DIT) in rats, considering the overall toxicity profile and the doses and endpoints selected for risk assessment the concern for the effects observed is low. Furthermore, there is no concern for neurotoxicity , and a developmental neurotoxicity

study (DNT) is not required at this time. HED recommends that the 10x FQPA safety factor be reduced to 1x. The risk assessment team has revi ewed the available data and has selected the doses and endpoints for risk assessment summarized in Table 5. Table 5. Summary of Toxicological Doses and Endpoints for Tolfenpyrad for Use in Dietary Human Health Risk Assessments. Exposure/ Scenario Point of

Departure Uncertainty/

FQPA Safety Factors RfD, PAD, Level

of Concern for Risk Assessment Study and Toxicological Effects Ac ute Dietary (General Population, including Infants and Children) NOAEL= 10

mg/kg/day UF A= 10 x

UF H=10 x FQPA SF=1x Ac ute RfD = 0.1

mg/kg/day aPAD = 0.1 mg/kg/day LOAEL=20 mg/kg/day from an acute

neurotoxicity study in rats, based on decreased body weight body weight gain and food consumption. Chronic Dietary (All Populations) NOAEL= 0.6

mg/kg/day UF A= 10 x

UF H=10 x FQPA SF=1 x Chronic RfD =

0.006 mg/kg/day cPAD = 0.006 mg/kg/day LOAEL = 1.5 mg/kg/day from a

combined chronic/carcinogenicity in rats, based on decreased body weight, body weight gain, and food consumption of females, gross changes in the Harderian glands of males, and histopathological changes in the liver, kidney , and me senteric lymph nodes of females and the kidney of males. Cancer Classification: “Not likely to be Carcinogenic to Humans” based on the absence of significant

tumor increases in two adequat e rodent carcinogenicity studies. 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 inTolfenpyrad Dietary Exposure and Risk Assessment DP Number: D398817

PC Code: 090111



### Page 9 of 18 sensitivity among members of the human population (intraspecies). FQPA SF = FQPA Safety Factor. PAD = population - adjusted dose (a = acute, c = chronic). RfD = reference dose. 

### VI. **Results/Discussion** As stated above, for acute and chronic assessments, HED is concerned when dietary risk exceeds 100% of the PAD. The DEEM - FCIDTM anal ys es estimate the dietary exposure of the U.S. population and various population subgroups. The results reported in Table 6 are for the general U.S. Population, all infants (<1 year old), children 1 - 2, children 3 - 5, children 6 - 12, youth 13 - 19, females 13 - 49, adults 20 - 49, and adults 50+ years. Table 6. Summary of Acute and Chronic Dietary Exposure Analyses for Tolfenpyrad. Population Subgroup Ac ute (95 th Percentile) Chronic Cancer Estimated Exposure (mg/kg/day) Estimated

Risk, % aPAD E stimated

E xposure (mg/kg/day) Estimated

Risk, % c PAD Exposure

(mg/kg/day) Estimated

Risk U.S. Population 0.0618 62 0.00169 28 Not Applicable All infants 0.0397 40 0.00309 52 **Children 1 -**  **2 yrs** 0.0727 73 **0.00413 69**  **Children 3 -**  **5 yrs 0.0757**  **76** 0.00328 55 Children 6 - 12 y

rs 0.0637 64 0.00190 32 Youth 13 - 19 y

rs 0.0559 56 0.00130 22 Adults 20 - 49 y

rs 0.0605 61 0.00133 22 Adults 50+ y

rs 0.0612 61 0.00173 29 Females 13 - 49 y

rs 0.0648 65 0.00139 23 Entries with the highest acute and chronic risk estimates are **bolded** . 

### Acute and chronic risk estimates are below HED’s level of concern for all population subgroups, including those of infants and children. **VII. Characterization of Inputs/Outputs**  For the acute assessment, the inputs to the analy sis can be characterized as highl y health protective. While the application of the juice processing factor from grapes to other juices prov ides some refinement relative to a strict screening - level assessment, the conservatism in the other input parameters results in exposure estimates that are likel y to overestimate actual dietary exposure. As previously

noted, the chronic assessment include s significant refinements. Nevertheless , the overall chronic exposure estimates still retain a rather high level of conservatism due to the source and scope of the refinements . The average residue values are from field trials which are designed to produc e worst - case residue levels (maximum application rate, shortest PHI) . The residue levels make no allowance for lower applications rate, longer PHI, or dissipation of residues during storage and transportation to market. Itis quite likel y that monitoring data, which take these issues into account, would show significantl y lower residues than those used in this assessment. Furthermore, the use of percent of crop treated estimates was limited to only a few crops and, in the case of grapes, to only a particular ty

pe (table grapes) . For all other crops, it was assumed that 100% of the planted acreage would be treated

– a situation which is highl yTolfenpyrad Dietary Exposure and Risk Assessment DP Number: D398817

PC Code: 090111



### Page 10 of 18 

### unlikely . Overall, the chronic risk estimates are likely to be overestimates of actual chronic dietary risk. **VIII. Conclusions**  Based on the results of these anal ys es, there are no dietary exposure considerations that would preclude granting the requested uses of tolfenp yr ad. **IX. List of Attachments**  Attachment 1. Summary of Inputs for the A cute D ietary Risk A ssessment for T olfenp yr ad. Attachment 2. Summary of Inputs for the C hronic D ietary Risk A ssessment for T olfenp yr ad. Attachment 3. Summary of the Acute Dietary

Anal ys is Results for Tolfenp yr ad. Attachment 4. Summary of the Chronic Dietary

Anal ys is Results for Tolfenp yr ad. Attachment 5. Percent Crop Treated Memorandum from the Biological and Economic Analysis

Division.Tolfenpyrad Dietary Exposure and Risk Assessment DP Number: D398817

PC Code: 090111



### Page 11 of 18 

### Attachment 1. Summary of inputs for the acute dietary risk assessment for tolfenpy rad. Filename: C: \ Docu ments and Settings \ mdoherty \ My Documents \ Chemistry Reviews \ !DEEM Runs \ Tolfenpyrad \ 090111 Tolfenpyrad Acute Tol Juice PF 27ppb .R98 Chemical: 090111 Tolfenpyrad RfD(Chronic): .006 mg/kg bw/day NOEL(Chronic): 0 mg/kg bw/day RfD(Acute): .1 mg/kg bw/day NOEL(Acute): 0 mg/kg bw/day Date created/last modified: 02 - 16 - 2012/11:56:35/8 Program ver. 2.03

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

-------- ---- ------------------------------- ---------- ------ ------ ------- 01032960 1C Potato, chips 0.010000 1.410 1.000 Factor 1 to ac count for PT - CA 01032970 1C Potato, dry (granules/ flakes) 0.010000 1.410 1.000 Factor 1 to account for PT - CA 01032971 1C Potato, dry (granules/ flakes) - b 0.010000 1.410 1.000 Factor 1 to account for PT - CA 01032980 1C Potato, flour 0.010000 1.410 1.000 Factor 1 to account for PT - CA 01032981 1C Potato, flour - babyfood 0.010000 1.410 1.000 Factor 1 to account for PT - CA 01032990 1C Potato, tuber, w/peel 0.010000 1.410 1.000 Factor 1 to account for PT - CA 01032991 1C Potato, tuber, w/peel - babyfood 0.010000 1.410 1.000 Factor 1 to account for PT - CA 01033000 1C Potato, tuber, w/o peel 0.010000 1.410 1.000 Factor 1 to account for PT - CA 01033001 1C Potato, tu ber, w/o peel - babyfood 0.010000 1.410 1.000 Factor 1 to account for PT - CA 04012040 4A Lettuce, head 30.000000 1.000 1.000 04012050 4A Lettuce, leaf 30.000000 1.000 1.000 04013550 4A Spinach 30.000000 1.000 1.000 04013551 4A Spinach - babyfood 30.000000 1.000 1.000 04020760 4B Cardoon 30.000000 1.000 1.000 04020850 4B Celery 30.000000 1.000 1.000 04020851 4B Celery - babyfood 30.000000 1.000 1.000 04020860 4B Celery, juice 30.000000 0.030 1.000 04020870 4B Celtuce 30.000000 1.000 1.000 04021520 4B Fennel, Florence 30.000000 1.000 1.000 04023220 4B Rhubarb 30.000000 1.000 1.000 04023670 4B Swiss chard 30.000000 1.000 1.000 05010610 5A Broccoli 5.000000 1.000 1.000 05010611 5A Broccoli - babyfood 5.000000 1.000 1.000 05010620 5A Broccoli, Chinese 5.000000 1.000 1.000 05010640 5A Brussels sprouts 5.000000 1.000 1.000 05010690 5A Cabbage 5.000000 1.000 1.000 05010710 5A Cabbage, Chinese, napa 5.000000 1.000 1.000 05010720 5A Cabbage, Chinese, mustard 5.000000 1.000 1.000 05010830 5A Cauliflower 5.000000 1.000 1.000 05011960 5A Kohlrabi 5.000000 1.000 1.000 05020630 5B Broccoli raab 40.000000 1.000 1.000 05020700 5B Cabbage, Chinese, bok choy 40.000000 1. 000 1.000 05021170 5B Collards 40.000000 1.000 1.000 05021940 5B Kale 40.000000 1.000 1.000 05022290 5B Mustard greens 40.000000 1.000 1.000 05023180 5B Rape greens 40.000000 1.000 1.000 05023890 5B Turnip, greens 40.000000 1.000 1.000 08001480 8 Eggplant 0.700000 1.000 1.000 08002340 8 Okra 0.700000 1.000 1.000 08002700 8 Pepper, bell 0.700000 1.000 1.000 08002701 8 Pepper, bell - babyfood 0.700000 1.000 1.000 08002710 8 Pepper, bell, dried 0.700000 1.000 1.000 08002 711 8 Pepper, bell, dried - babyfood 0.700000 1.000 1.000 08002720 8 Pepper, nonbell 0.700000 1.000 1.000 08002721 8 Pepper, nonbell - babyfood 0.700000 1.000 1.000 08002730 8 Pepper, nonbell, dried 0.700000 1.000 1.000 08003740 8 Tomatillo 0.700000 1.000 1.000 08003750 8 Tomato 0.700000 1.000 1.000 08003751 8 Tomato - babyfood 0.700000 1.000 1.000 08003760 8 Tomato, paste 0.700000 1.020 1.000 08003761 8 Tomato, paste - babyfood 0.700000 1.020 1.000 08003770 8 Tomato, puree 0.700000 0.300 1.000 08003771 8 Tomato, puree - babyfood 0.700000 0.300 1.000 08003780 8 Tomato, dried 0.700000 14.300 1.000 08003781 8 Tomato, dried - babyfood 0.700000 14.300 1.000 08003790 8 Tomato, juice 0.700000 0.030 1.000 09010750 9A Cantaloupe 0.700000 1.000 1.000 09010800 9A Casaba 0.700000 1.000 1.000 09011870 9A Honeydew melon 0.700000 1. 000 1.000 09013990 9A Watermelon 0.700000 1.000 1.000 09014000 9A Watermelon, juice 0.700000 0.030 1.000 09020210 9B Balsam pear 0.700000 1.000 1.000 09020880 9B Chay ote, fruit 0.700000 1.000 1.000 09021020 9B Chinese waxgourd 0.700000 1.000 1.000 09021350 9B Cucumber 0.700000 1.000 1.000 09023080 9B Pumpkin 0.700000 1.000 1.000 09023090 9B Pumpkin, seed 0.700000 1.000 1.000 09023560 9B Squash, summer 0.700000 1.000 1.000Tolfenpyrad Dietary Exposure and Risk Assessment DP Number: D398817

PC Code: 090111



### Page 12 of 18 09023561 9B Squash, summer - babyfood 0.700000 1.000 1.000 09023 570 9B Squash, winter 0.700000 1.000 1.000 09023571 9B Squash, winter - babyfood 0.700000 1.000 1.000 10001060 10 Citrus citron 1.500000 1.000 1.000 10001070 10 Citrus hybrids 1.500000 1.000 1.000 10001080 10 Citrus, oil 70.000000 1.000 1.000 10001800 10 Grapefruit 1.500000 1.000 1.000 10001810 10 Grapefruit, juice 1.500000 0.020 1.000 10001970 10 Kumquat 1.500000 1.000 1.000 10001990 10 Lemon 1.500000 1.000 1.000 10002000 10 Lemon, juice 1.500000 0.020 1.000 10002001 10 Lemon, juice - babyfood 1.500000 0.020 1.000 10002010 10 Lemon, peel 1.500000 1.000 1.000 10002060 10 Lime 1.500000 1.000 1.000 10002070 10 Lime, juice 1.500000 0.020 1.000 10002071 10 Lime, juice - babyfood 1.500000 0.020 1.000 10002400 10 Orange 1.500000 1.000 1.000 10002410 10 Orange, juice 1.500000 0.020 1.000 10002411 10 Orange, juice - babyfood 1.500000 0.020 1.000 10002420 10 Orange, peel 1.500000 1. 000 1.000 10003070 10 Pummelo 1.500000 1.000 1.000 10003690 10 Tangerine 1.500000 1.000 1.000 10003700 10 Tangerine, juice 1.500000 0.020 1.000 11000070 11 Appl e, fruit with peel 0.700000 1.000 1.000 11000080 11 Apple, peeled fruit 0.700000 1.000 1.000 11000081 11 Apple, peeled fruit - babyfood 0.700000 1.000 1.000 11000090 11 Apple, dried 0.700000 8.000 1.000 11000091 11 Apple, dried - babyfood 0.700000 8.000 1.000 11000100 11 Apple, juice 0.700000 0.010 1.000 11000101 11 Apple, juice - babyfood 0.700000 0.010 1.000 11000 110 11 Apple, sauce 0.700000 1.000 1.000 11000111 11 Apple, sauce - babyfood 0.700000 1.000 1.000 11001290 11 Crabapple 0.700000 1.000 1.000 11002100 11 Loquat 0.700000 1.000 1.000 11002660 11 Pear 0.700000 1.000 1.000 11002661 11 Pear - babyfood 0.700000 1.000 1.000 11002670 11 Pear, dried 0.700000 6.250 1.000 11002680 11 Pear, juice 0.700000 0.010 1.000 11002681 11 Pear, juice - babyfood 0.700000 0.010 1.000 11003100 11 Quince 0.700000 1.000 1.000 12000120 12 Apricot 2.000000 1.000 1.000 12000121 12 Apricot - babyfood 2.000000 1.000 1.000 12000130 12 Apricot, dried 2.000000 6.000 1.000 12000140 12 Apricot, juice 2.000000 0.030 1.000 12000141 12 Apricot, juice - babyfood 2.000000 0.030 1.000 12000900 12 Cherry 2.000000 1.000 1.000 12000901 12 Cherry - babyfood 2.000000 1.000 1.000 12000910 12 Cherry, juice 2.000000 0.030 1.000 12000911 12 Cherry, juice - babyfood 2.000000 0.030 1.000 12002300 12 Nectarine 2.000000 1. 000 1.000 12002600 12 Peach 2.000000 1.000 1.000 12002601 12 Peach - babyfood 2.000000 1.000 1.000 12002610 12 Peach, dried 2.000000 7.000 1.000 12002611 12 Peac h, dried - babyfood 2.000000 7.000 1.000 12002620 12 Peach, juice 2.000000 0.030 1.000 12002621 12 Peach, juice - babyfood 2.000000 0.030 1.000 12002850 12 Plum 2.000000 1.000 1.000 12002851 12 Plum - babyfood 2.000000 1.000 1.000 12002860 12 Plum, prune, fresh 2.000000 1.000 1.000 12002861 12 Plum, prune, fresh - babyfood 2.000000 1.000 1.000 12002 870 12 Plum, prune, dried 3.000000 1.000 1.000 12002871 12 Plum, prune, dried - babyfood 3.000000 1.000 1.000 12002880 12 Plum, prune, juice 2.000000 0.030 1.000 12002881 12 Plum, prune, juice - bab yfood 2.000000 0.030 1.000 14000030 14 Almond 0.050000 1.000 1.000 14000031 14 Almond - babyfood 0.050000 1.000 1.000 14000040 14 Almond, oil 0.050000 1.000 1.000 14000041 14 Almond, oil - babyfood 0.050000 1.000 1.000 14000590 14 Brazil nut 0.050000 1.000 1.000 14000680 14 Butternut 0.050000 1.000 1.000 14000810 14 Cashew 0.050000 1.000 1.000 14000920 14 Chestnut 0.050000 1.000 1.000 14001550 14 Filbert 0.050000 1.000 1.000 14001560 14 Filbert, oil 0.050000 1.000 1.000 14001850 14 Hickory nut 0.050000 1.000 1.000 14002130 14 Macadamia nut 0.050000 1.000 1.000 14002690 14 Pecan 0.050000 1. 000 1.000 14002820 14 Pistachio 0.050000 1.000 1.000 14003910 14 Walnut 0.050000 1.000 1.000 21000440 M Beef, meat 0.010000 1.000 1.000 21000441 M Beef , meat - babyfood 0.010000 1.000 1.000Tolfenpyrad Dietary Exposure and Risk Assessment DP Number: D398817

PC Code: 090111



### Page 13 of 18 21000450 M Beef, meat, dried 0.010000 1.920 1.000 21000460 M Beef, meat byproducts 0.350000 1.470 1.000 Factor 1 to account for OH - PT - CA 21000461 M Bee f, meat byproducts - babyfood 0.350000 1.470 1.000 Factor 1 to account for OH - PT - CA 21000470 M Beef, fat 0.010000 1.000 1.000 21000471 M Beef,fat - babyfood 0.010000 1.000 1.000 21000480 M Be ef, kidney 0.350000 1.470 1.000 Factor 1 to account for OH - PT - CA 21000490 M Beef, liver 0.350000 1.470 1.000 Factor 1 to account for OH - PT - CA 21000491 M Beef, liver - babyfood 0.350000 1.470 1.000 Factor 1 to account for OH - PT - CA 23001690 M Goat, meat 0.010000 1.000 1.000 23001700 M Goat, meat byproducts 0.350000 1.470 1.000 Factor 1 to account for OH - PT - CA 23001710 M Goat, fat 0.010000 1.000 1.000 23001720 M Goat, kidney 0.350000 1.470 1.000 Factor 1 to account for OH - PT - CA 23001730 M Goat, liver 0.350000 1.470 1.000 Factor 1 to account for O H - PT - CA 24001890 M Horse, meat 0.010000 1.000 1.000 26003390 M Sheep, meat 0.010000 1.000 1.000 26003391 M Sheep, meat - babyfood 0.010000 1.000 1.000 26003400 M Sheep, me at byproducts 0.350000 1.470 1.000 Factor 1 to account for OH - PT - CA 26003410 M Sheep, fat 0.010000 1.000 1.000 26003411 M Sheep, fat - babyfood 0.010000 1.000 1.000 26003420 M Sheep, kidney 0.350000 1.470 1.000 Factor 1 to account for OH - PT - CA 26003430 M Sheep, liver 0.350000 1.470 1.000 Factor 1 to account for OH - PT - CA 27002220 D Milk, fat 0.030000 1.0 00 1.000 27002221 D Milk, fat - baby food/infant for 0.030000 1.000 1.000 27012230 D Milk, nonfat solids 0.030000 1.000 1.000 27012231 D Milk, nonfat solids - baby food/in 0.030000 1.000 1.000 27022240 D Milk, water 0.030000 1.000 1.000 27022241 D Milk, water - babyfood/infant form 0.030000 1.000 1.000 27032251 D Milk, sugar (lactose) - baby food/ 0.030000 1.000 1.000 29003120 M Rabbit, meat 0 .010000 1.000 1.000 86010000 O Water, direct, all sources 0.026900 1.000 1.000 86020000 O Water, indirect, all sources 0.026900 1.000 1.000 95001280 O Cottonseed, oil 0.700000 0.050 1.000 950012 81 O Cottonseed, oil - babyfood 0.700000 0.050 1.000 95001750 O Grape 2.000000 1.000 1.000 95001760 O Grape, juice 2.000000 0.030 1.000 95001761 O Grape, juice - babyfood 2.000000 0.030 1.000 95001770 O Grape, leaves 2.000000 1.000 1.000 95001780 O Grape, raisin 6.000000 1.000 1.000 95001790 O Grape, wine and sherry 2.000000 0.030 1 .000 95002770 O Persimmon 2.000000 1.000 1.000 From Stone Fruit 95002890 O Pomegranate 2.000000 1.000 1.000 From Stone Fruit 95003720 O Tea, dried 30.000000 1.000 1.000 95003730 O Tea, instant 30.000000 1.000 1.000 95003800 O Tomato, Tree 0.700000 1.000 1.000Tolfenpyrad Dietary Exposure and Risk Assessment DP Number: D398817

PC Code: 090111



### Page 14 of 18 

### Attachment 2. Summary of inputs for the chronic dietary risk assessment for tolfenp yrad. Filename: C: \ Documents and Settings \ mdoherty \ My Documents \ Chemistry Reviews \ !DEEM Runs \ Tolfenpyrad \ 090111 Tolfenpyrad Chronic Average Juice PF 12ppb PCTn.R98 Chemical: 090111 Tolfenpyrad RfD(Chronic): .006 mg/kg bw/day NOEL(Chronic): 0 mg/kg bw/day RfD(Ac ute): .1 mg/kg bw/day NOEL(Acute): 0 mg/kg bw/day Date created/last modified: 02 - 16 - 2012/11:57:03/8 Program ver. 2.03

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

-------- ---- ------------------------------- ---------- ------ ------ ------- 01032960 1C Potato, chips 0.010000 1.410 1.000 Factor 1 to account for PT - CA 01032970 1C Potato, dry (granules/ flakes) 0.010000 1.410 1.000 Factor 1 to account for PT - CA 01032971 1C Potato, dry (granules/ flakes) - b 0.010000 1.410 1.000 Factor 1 to account for PT - CA 01032980 1C Potato, flour 0.010000 1.410 1.000 Factor 1 to account for PT - CA 01032981 1C Potato, flour - babyfood 0.010000 1.410 1.000 Factor 1 to account for PT - CA 01032990 1C Potato, tuber, w/peel 0.010000 1.410 1.000 Factor 1 to account for PT - CA 01032991 1C Potato, tuber, w/peel - babyfood 0.010000 1.410 1.000 Factor 1 to account for PT - CA 01033000 1C Potato, tuber, w/o peel 0.010000 1.410 1.000 Factor 1 to account for PT - CA 0 1033001 1C Potato, tuber, w/o peel - babyfood 0.010000 1.410 1.000 Factor 1 to account for PT - CA 04012040 4A Lettuce, head 1.590000 0.080 1.000 Factor for removal of wrapper leaves 04012050 4A Lettuce, leaf 5.450000 1.000 1.000 04013550 4A Spinach 9.880000 1.000 0.500 04013551 4A Spinach - babyfood 9.880000 1.000 0.500 04020760 4B Cardoon 2.710000 1.000 1.000 04020850 4B Celery 2.710000 1.000 1.000 04020851 4B Celery - babyfood 2.710000 1.000 1.000 04020860 4B Celery, juice 2.710000 0.030 1.000 04020870 4B Celtuce 2.710000 1.000 1.000 04021520 4B Fennel, Florence 2.710000 1.000 1.000 04023220 4B Rhubarb 2.710000 1.000 1.000 04023670 4B Swiss chard 2.710000 1.000 1.000 05010610 5A Broccoli 0.199000 1.000 1.000 05010611 5A Broccoli - babyfood 0.199000 1.000 1.000 05010620 5A Broccoli, Chinese 0.199000 1.000 1.000 05010640 5A Brussels sprouts 1.430000 1.000 1.000 05010690 5A Cabbage 1.430000 0.080 1.000 Factor for removal of wrapper leaves 05010710 5A Cabbage, Chi nese, napa 1.430000 0.080 1.000 Factor for removal of wrapper leaves 05010720 5A Cabbage, Chinese, mustard 0.199000 1.000 1.000 05010830 5A Cauliflower 0.199000 1.000 1.000 05011960 5A Kohlrab i 1.430000 1.000 1.000 05020630 5B Broccoli raab 8.620000 1.000 1.000 05020700 5B Cabbage, Chinese, bok choy 8.620000 1.000 1.000 05021170 5B Collards 8.6 20000 1.000 1.000 05021940 5B Kale 8.620000 1.000 1.000 05022290 5B Mustard greens 8.620000 1.000 1.000 05023180 5B Rape greens 8.620000 1.000 1.000 05023890 5B Turnip, greens 8.620000 1.000 1.000 08001480 8 Eggplant 0.090000 1.000 1.000 08002340 8 Okra 0.233000 1.000 1.000 From non - bell pepper 08002700 8 Peppe r, bell 0.090000 1.000 1.000 08002701 8 Pepper, bell - babyfood 0.090000 1.000 1.000 08002710 8 Pepper, bell, dried 0.090000 1.000 1.000 08002711 8 Pepper, bell, dried - babyfood 0 .090000 1.000 1.000 08002720 8 Pepper, nonbell 0.233000 1.000 1.000 08002721 8 Pepper, nonbell - babyfood 0.233000 1.000 1.000 08002730 8 Pepper, nonbell, dried 0.233000 1.000 1.000 080037 40 8 Tomatillo 0.124000 1.000 1.000 08003750 8 Tomato 0.124000 1.000 1.000 08003751 8 Tomato - babyfood 0.124000 1.000 1.000 08003760 8 Tomato, paste 0.124000 1.020 1.000 08003761 8 Tomato, paste - babyfood 0.124000 1.020 1.000 08003770 8 Tomato, puree 0.124000 0.300 1.000 08003771 8 Tomato, puree - bab yfood 0.124000 0.300 1.000 08003780 8 Tomato, dried 0.124000 14.300 1.000 08003781 8 Tomato, dried - babyfood 0.124000 14.300 1.000 08003790 8 Tomato, juice 0.124000 0. 030 1.000 09010750 9A Cantaloupe 0.230000 1.000 1.000 09010800 9A Casaba 0.230000 1.000 1.000 09011870 9A Honeydew melon 0.230000 1.000 1.000 09013990 9A Wate rmelon 0.230000 1.000 1.000 09014000 9A Watermelon, juice 0.230000 0.030 1.000 09020210 9B Balsam pear 0.120000 1.000 1.000 09020880 9B Chayote, fruit 0.047000 1.000 1.000 09021020 9B Chinese waxgourd 0.120000 1.000 1.000 09021350 9B Cucumber 0.120000 1.000 1.000 09023080 9B Pumpkin 0.047000 1.000 1.000 09023 090 9B Pumpkin, seed 0.047000 1.000 1.000 09023560 9B Squash, summer 0.047000 1.000 1.000Tolfenpyrad Dietary Exposure and Risk Assessment DP Number: D398817

PC Code: 090111



### Page 15 of 18 09023561 9B Squash, summer - babyfood 0.047000 1.000 1.000 09023570 9B Squash, winter 0.047000 1.000 1.000 09023571 9B Squash, winter - babyfood 0.047000 1.000 1.000 10001060 10 Citrus citron 0.409000 1.000 1.000 10001070 10 Citrus hybrids 0.409000 1.000 1.000 10001080 10 Citrus, oil 0.409000 82.000 1.000 10001800 10 Grapefruit 0.217000 1.000 1.000 10001810 10 Grapefruit, juice 0.217000 0.020 1.000 10001970 10 Kumquat 0.409000 1.000 1.000 10001990 10 Lemon 0.437000 1.000 1.000 10002000 10 Lemon, juice 0.437000 0.020 1.000 10002001 10 Lemon, juice - baby food 0.437000 0.020 1.000 10002010 10 Lemon, peel 0.437000 1.000 1.000 10002060 10 Lime 0.437000 1.000 1.000 10002070 10 Lime, juice 0.437000 0. 020 1.000 10002071 10 Lime, juice - babyfood 0.437000 0.020 1.000 10002400 10 Orange 0.409000 1.000 0.400 10002410 10 Orange, juice 0.409000 0.020 0.400 10002411 10 Oran ge, juice - babyfood 0.409000 0.020 0.400 10002420 10 Orange, peel 0.409000 1.000 0.400 10003070 10 Pummelo 0.217000 1.000 1.000 10003690 10 Tangerine 0.409000 1.000 1.000 10003700 10 Tangerine, juice 0.409000 0.020 1.000 11000070 11 Apple, fruit with peel 0.206000 1.000 0.600 11000080 11 Apple, peeled fruit 0.206000 1.000 0.600 11000 081 11 Apple, peeled fruit - babyfood 0.206000 1.000 0.600 11000090 11 Apple, dried 0.206000 8.000 0.600 11000091 11 Apple, dried - babyfood 0.206000 8.000 0.600 11000100 11 Apple, juice 0.206000 0.010 0.600 11000101 11 Apple, juice - babyfood 0.206000 0.010 0.600 11000110 11 Apple, sauce 0.206000 1.000 0.600 11000111 11 Apple, sauce - babyfood 0.206000 1.000 0.600 11001290 11 Crabapple 0.206000 1.000 1.000 11002100 11 Loquat 0.199000 1.000 1.000 11002660 11 Pear 0.199000 1.000 1.000 11002661 11 Pear - baby food 0.199000 1.000 1.000 11002670 11 Pear, dried 0.199000 6.250 1.000 11002680 11 Pear, juice 0.199000 0.010 1.000 11002681 11 Pear, juice - babyfood 0.199000 0.010 1.000 11003100 11 Quince 0.199000 1.000 1.000 12000120 12 Apricot 0.362000 1.000 1.000 12000121 12 Apricot - babyfood 0.362000 1.000 1.000 12000130 12 Apricot, dried 0.362000 6.000 1.000 12000140 12 Apricot, juice 0.362000 0.030 1.000 12000141 12 Apricot, juice - babyfood 0.362000 0. 030 1.000 12000900 12 Cherry 0.551000 1.000 1.000 12000901 12 Cherry - babyfood 0.551000 1.000 1.000 12000910 12 Cherry, juice 0.551000 0.030 1.000 12000911 12 Cher ry, juice - babyfood 0.551000 0.030 1.000 12002300 12 Nectarine 0.362000 1.000 1.000 12002600 12 Peach 0.362000 1.000 1.000 12002601 12 Peach - babyfood 0.362000 1.000 1.000 12002610 12 Peach, dried 0.362000 7.000 1.000 12002611 12 Peach, dried - babyfood 0.362000 7.000 1.000 12002620 12 Peach, juice 0.362000 0.030 1.000 12002 621 12 Peach, juice - babyfood 0.362000 0.030 1.000 12002850 12 Plum 0.402000 1.000 1.000 12002851 12 Plum - babyfood 0.402000 1.000 1.000 12002860 12 Plum, prune, fresh 0.402000 1.000 1.000 12002861 12 Plum, prune, fresh - babyfood 0.402000 1.000 1.000 12002870 12 Plum, prune, dried 0.402000 2.900 1.000 12002871 12 Plum, prune, dried - babyfood 0.402000 2.900 1.000 12002880 12 Plum, prune, juice 0.402000 0.030 1.000 12002881 12 Plum, prune, juice - babyfood 0.402000 0.030 1.000 14000030 14 Almond 0.013000 1.000 1.000 14000031 14 Almond - ba byfood 0.013000 1.000 1.000 14000040 14 Almond, oil 0.013000 1.000 1.000 14000041 14 Almond, oil - babyfood 0.013000 1.000 1.000 14000590 14 Brazil nut 0.010000 1.000 1.000 14000680 14 Butternut 0.010000 1.000 1.000 14000810 14 Cashew 0.010000 1.000 1.000 14000920 14 Chestnut 0.013000 1.000 1.000 14001550 14 Filbert 0.010000 1.000 1.000 14001560 14 Filbert, oil 0.010000 1.000 1.000 14001850 14 Hickory nut 0.010000 1. 000 1.000 14002130 14 Macadamia nut 0.010000 1.000 1.000 14002690 14 Pecan 0.010000 1.000 1.000 14002820 14 Pistachio 0.013000 1.000 1.000 14003910 14 Waln ut 0.010000 1.000 1.000 21000440 M Beef, meat 0.010000 1.000 1.000 21000441 M Beef, meat - babyfood 0.010000 1.000 1.000Tolfenpyrad Dietary Exposure and Risk Assessment DP Number: D398817

PC Code: 090111



### Page 16 of 18 21000450 M Beef, meat, dried 0.010000 1.920 1.000 21000460 M Beef, meat byproducts 0.350000 1.470 1.000 Factor 1 to account for OH - PT - CA 21000461 M Beef, meat byproducts - babyfood 0.350000 1.470 1.000 Factor 1 to account for OH - PT - CA 21000470 M Be ef, fat 0.010000 1.000 1.000 21000471 M Beef,fat - babyfood 0.010000 1.000 1.000 21000480 M Beef, kidney 0.350000 1.470 1.000 Factor 1 to account for OH - PT - CA 21000490 M B eef, liver 0.350000 1.470 1.000 Factor 1 to account for OH - PT - CA 21000491 M Beef, liver - babyfood 0.350000 1.470 1.000 Factor 1 to account for OH - PT - CA 23001690 M Goat, meat 0.010000 1.000 1.000 23001700 M Goat, meat byproducts 0.350000 1.470 1.000 Factor 1 to account for OH - PT - CA 23001710 M Goat, fat 0.010000 1.000 1.000 23001720 M Goat, kidney 0.35000 0 1.470 1.000 Factor 1 to account for OH - PT - CA 23001730 M Goat, liver 0.350000 1.470 1.000 Factor 1 to account for OH - PT - CA 24001890 M Horse, meat 0.010000 1.000 1.000 26003390 M Sheep, meat 0.010000 1.000 1.000 26003391 M Sheep, meat - babyfood 0.010000 1.000 1.000 26003400 M Sheep, meat byproducts 0.350000 1.470 1.000 Factor 1 to account for OH - PT - CA 26003410 M Sheep, fat 0.010000 1.000 1.000 26003411 M Sheep, fat - babyfood 0.010000 1.000 1.000 26003420 M Sheep, kidney 0.350000 1.470 1.000 Factor 1 to account for OH - PT - C A 26003430 M Sheep, liver 0.350000 1.470 1.000 Factor 1 to account for OH - PT - CA 27002220 D Milk, fat 0.030000 1.000 1.000 27002221 D Milk, fat - baby food/infant for 0.030000 1.000 1.000 27012230 D Milk, nonfat solids 0.030000 1.000 1.000 27012231 D Milk, nonfat solids - baby food/in 0.030000 1.000 1.000 27022240 D Milk, water 0.030000 1.000 1.000 27022241 D Milk, water - ba byfood/infant form 0.030000 1.000 1.000 27032251 D Milk, sugar (lactose) - baby food/ 0.030000 1.000 1.000 29003120 M Rabbit, meat 0.010000 1.000 1.000 86010000 O Water, direct, all sources 0.012200 1.000 1.000 86020000 O Water, indirect, all sources 0.012200 1.000 1.000 95001280 O Cottonseed, oil 0.172000 0.050 1.000 95001281 O Cottonseed, oil - babyfood 0.172000 0.050 1.000 95001750 O G rape 0.530000 1.000 0.650 95001760 O Grape, juice 0.530000 0.030 1.000 95001761 O Grape, juice - babyfood 0.530000 0.030 1.000 95001770 O Grape, leaves 0.530000 1.000 1.000 95001780 O Grape, raisin 0.530000 3.700 1.000 95001790 O Grape, wine and sherry 0.530000 0.030 1.000 95002770 O Persimmon 0.551000 1.000 1.000 Fro m Cherry 95002890 O Pomegranate 0.551000 1.000 1.000 From Cherry 95003720 O Tea, dried 7.060000 1.000 1.000 95003730 O Tea, instant 7.060000 1.000 1.000 95003800 O Tomato, Tree 0.124000 1.000 1.000Tolfenpyrad Dietary Exposure and Risk Assessment DP Number: D398817

PC Code: 090111



### Page 17 of 18 

### Attachment 3. Summary of the Acute Dietary Analy sis Results for Tolfenpy rad. U.S. Environmental Protection Agency Ver. 2.02 DEEM - FCID ACUTE Analy sis for 090111 TOLFENPYRAD (1994 - 98 data) Residue file: 090111 Tolfenpyrad Acute Tol Juice PF 27ppb .R98 Adjustment factor #2 NOT used. Analysis Date: 02 - 16 - 2012/11:59:27 Residue file dated: 02 - 16 - 2012/11:56:35/8 Daily totals for food a nd foodform consumption used. Run Comment: ""

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

---------- -------- ---------- -------- ---------- -------- U.S. Population: 0.061772 61.77 0.115917 115.92 0.245781 245.78 All infants : 0.039670 39.67 0.215898 215.90 0.563094 563.09 Children 1 - 2 yrs: 0.072680 72.68 0.186896 186.90 0.543704 543.70 Children 3 - 5 yrs: 0.075748 75.75 0.169428 169. 43 0.445338 445.34 Children 6 - 12 yrs: 0.063718 63.72 0.108496 108.50 0.259444 259.44 Youth 13 - 19 yrs: 0.055872 55.87 0.108933 108.93 0.171462 171.46 Adults 20 - 49 yrs: 0.060546 60.55 0.111102 111.10 0.194507 194.51 Adults 50+ yrs: 0.061222 61.22 0.112822 112.82 0.191438 191.44 Females 13 - 49 yrs: 0.064780 64.78 0.111422 111.42 0.201754 201.75Tolfenpyrad Dietary Exposure and Risk Assessment DP Number: D398817

PC Code: 090111



### Page 18 of 18 

### Attachment 4. Summary of the Chronic Dietary Analy sis Results for Tolfenpy rad. U.S. Environmental Protection Agency Ver. 2.00 DEEM - FCID Chronic analysis for 090111 TOLFENPYRAD (1994 - 9 8 data) Residue file name: C: \ Documents and Settings \ mdoherty \ My Documents \ Chemistry Reviews \ !DEEM Runs \ Tolfenpyrad \ 090111 Tolfenpyrad Chronic Average Juice PF 12ppb PCTn.R98 Adjustment factor #2 used. A nalysis Date 02 - 16 - 2012/11:58:40 Residue file dated: 02 - 16 - 2012/11:57:03/8 Reference dose (RfD, Chronic) = .006 mg/kg bw/day

=============================================================================== Total exposure by populatio n subgroup

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

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

-------------------------------------- ------------- --------------- U.S. Population (total) 0 .001694 28.2% U.S. Population (spring season) 0.001669 27.8% U.S. Population (summer season) 0.001761 29.4% U.S. Population (autumn season) 0.001680 28.0% U.S. Population (winter season) 0.001664 27.7% Northeast region 0.001734 28.9% Midwest region 0.001548 25.8% Southern region 0.001654 27.6% Western region 0.001877 31.3% Hispanics 0.001564 26.1% Non - hispanic whites 0.001524 25 .4% Non - hispanic blacks 0.002345 39.1% Non - hisp/non - white/non - black 0.002942 49.0% All infants (< 1 year) 0.003092 51.5% Nursing infants 0.001440 24.0% Non - nursing infants 0.003718 62.0% Children 1 - 6 yrs 0.003439 57.3% Children 7 - 12 yrs 0.001788 29.8% Females 13 - 19 (not preg or nursing) 0.001141 19.0% Females 20+ (not preg or nursing) 0.001588 26.5% Females 13 - 50 yrs 0.001434 23.9% Females 13+ (preg/not nursing) 0.001360 22.7% Females 13+ (nursing) 0.001641 27.3% Males 13 - 19 yrs 0.001445 24.1% Males 20+ yrs 0.001358 22.6% Seniors 55+ 0.001755 29.2% Children 1 - 2 yrs 0.004127 68.8% Children 3 - 5 yrs 0.003277 54.6% Children 6 - 12 yrs 0.001904 31.7% Youth 13 - 19 yrs 0.001297 21.6% Adults 20 - 49 yrs 0.001334 22.2% Adults 50+ yrs 0.00 1726 28.8% Females 13 - 49 yrs 0.001390 23.2%

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