Tolfenpyrad Dietary Exposure and Risk Assessment DP Number: D398817

PC Code: 090111

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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, 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

TXR No.: None CAS No.: 129558-76-5

MRID Nos.: 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)

Driss Benmhend/Mark Suarez (Team 13)

Insecticide Branch

Registration Division (7505P)
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Executive 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 Surveys of Food Intakes by Individuals (CSFII) from 1994-1996 and 1998. The 

analyses 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 cancer 

assessment was not conducted. Tolfenpyrad is classified as “not likely to be carcinogenic to 

humans;” therefore, there is no cancer risk associated with tolfenpyrad.

The acute assessment is a screening-level, highly conservative assessment. Inputs to the analysis 

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 95th

percentile is 0.076 mg/kg/day, which corresponds to 76% of the aPAD. Typically HED has 

concerns when exposures exceed 100% of the acute or chronic population-adjusted dose (aPAD 

or cPAD). Acute dietary risk estimates are below HED’s level of concern for all population 

subgroups.

The chronic assessment is significantly 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 analysis is not expected to underestimate dietary

exposures. The highest chronic dietary exposure estimate is 0.0041 mg/kg/day, which 

corresponds to 69% 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 

tolfenpyrad.

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 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 generally 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 Exposure 
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from Pesticides, A User’s Guide,” 21-JUN-2000, web link: http://www.epa.gov/fedrgstr/EPAPEST/2000/July/Day-12/6061.pdf; or see SOP 99.6 (20-AUG-1999).

This is the first food-use assessment for tolfenpyrad.

II. Residue Information

The Agency has received a petition requesting use of tolfenpyrad on a large number of crops. 

This is the first food-use petition for this chemical. As such, there are no tolerance entries for 

tolfenpyrad in the Code of Federal Regulation (CFR) at this time.

The toxicological and residue chemistry databases for tolfenpyrad 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-CA1(root crops only) Tolfenpyrad

Rotational Crop --

2

--

Livestock Ruminant Tolfenpyrad + PT-CA + OH-PT-CA3 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-PTCA in ruminant liver, kidney, and other meat byproducts 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. In the 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 tolfenpyrad is 0.41. A factor of 1.41 has been 

used in the input files (Attachments 1 and 2) to convert tolfenpyrad to tolfenpyrad + PT-CA for 

potato commodities (the only root crop in the current request). Similarly, in the goat metabolism 

study, tolfenpyrad + PT-CA account for 59% TRR and 63% TRR in liver and kidney, 

respectively. 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-byproduct 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 exception of 
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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. The factor of 0.03 is from the processing of 

grapes into grape juice and is the maximum juice factor in the tolfenpyrad database. Even with 

this refinement, the acute assessment should be considered a screening-level assessment and very

conservative with respect 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 

average values (Table 2) from crop field trials. For crop group commodities, a standard 

procedure1 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, D393941, 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

Tolerance Mean Translated to

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).
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Table 2. Summary of Crop Field Trial Residue Data.

Commodity

Residue, ppm

Tolerance Mean Translated to

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 Pumpkin, 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 byproducts)

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, D393941, 6 February 2012

Crop Year Market Leader Percent

Crop

Treated

PCTn for Tolfenpyrad*

Chronic (Avg.) Acute (Max.)

Oranges 2009 Petroleum Distillate 62% 40 60
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2005 Spinosad 32%

2003 S-methoprene 17%

Apples

2009 Carbaryl 51%

2007 Azinphos-methyl 62% 60 65

2005 Azinphos-methyl 63%

Table Grapes

2010

Proprietary Proprietary

65 90

2009

2008

2007

2006

2005

Spinach

2010 Permethrin 53%

2006 Spinosad 47% 50 55

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 by the Environmental Fate and Effects Division (EFED) in the following 

memorandum: “Drinking Water Exposure Assessment for Proposed New Uses of Tolfenpyrad 

on a Variety of Agricultural Crops, Nurseries, and Christmas Trees” (L. Liu, D383822, 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 based on the submitted environmental fate data and 

reported physical-chemical properties, tolfenpyrad and its transformation products are expected 

to moderately degrade in the environment. In soil, tolfenpyrad is expected to be essentially 

immobile; however, the degradates PCA and PT-CA are expected to be highly 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.

Tolfenpyrad 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 studies become available, 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 tolfenpyrad are represented by the 

use pattern of maximum tolfenpyrad exposure, nurseries and Christmas trees (Table 4). 

Maximum acute, chronic, and cancer EDWCs in surface water are 26.9, 12.2, and 4.8 μg/L, 

respectively. The maximum exposure estimate for ground water is 11 μg/L. Monitoring and 

drinking water treatment data on tolfenpyrad are not available. The model and its description are 

available at the EPA internet site: http://www.epa.gov/oppefed1/models/water/. 
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Table 4. Tolfenpyrad EDWCs in Surface Water and Ground Water for Use in Dietary Risk 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

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

Exposure Evaluation Model software with the Food Commodity Intake Database DEEMFCIDTM, Version 2.03 which incorporates consumption data from USDA’s Continuing Surveys 

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

days. Foods “as consumed” (e.g., apple pie) are linked to EPA-defined food commodities (e.g.,

apples, peeled fruit - cooked; fresh or N/S; baked; or wheat flour - cooked; fresh or N/S, baked) 

using publicly available recipe translation files developed jointly by USDA/ARS and EPA. For 

chronic exposure assessment, consumption data are averaged for the entire U.S. population and 

within population subgroups, but for acute exposure assessment are retained as individual 

consumption events. Based on analysis of the 1994-96, 98 CSFII 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 subgroups: the general U.S. population, all infants (<1 

year old), children 1-2, children 3-5, children 6-12, youth 13-19, adults 20-49, females 13-49, 

and adults 50+ years old.

For chronic dietary exposure assessment, an estimate of the residue level in each food or foodform (e.g., orange or orange juice) on the food commodity residue list is multiplied by the 

average daily consumption estimate for that food/food form to produce a residue intake estimate. 

The resulting residue intake estimate for each food/food form is summed with the residue intake 

estimates for all other food/food forms on the commodity residue list to arrive at the total 

average estimated exposure. Exposure is expressed in mg/kg body weight/day and as a percent 

of the cPAD. This procedure is performed for each population subgroup.

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

individual-by-individual basis. The reported consumption amounts of each food 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., only those who reported eating 

relevant commodities/food forms) and a per-capita (i.e., those who reported eating the relevant 
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commodities as well as those who did not) basis. In accordance with HED policy, per capita 

exposure and risk are reported for all tiers of analysis. However, for tiers 1 and 2, any significant 

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

risk assessment.

V. Toxicological Information

A variety of toxic effects were noted in the toxicology database for tolfenpyrad; however, 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 

young 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 reviewed 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

Acute Dietary 

(General 

Population, 

including Infants 

and Children)

NOAEL= 10 

mg/kg/day

UFA= 10 x

UFH=10 x

FQPA SF=1x

Acute 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

UFA= 10 x

UFH=10 x

FQPA SF=1x

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 mesenteric 

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 adequate 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 observed adverse effect level. LOAEL = lowest observed adverse effect level. UF = 

uncertainty factor. UFA = extrapolation from animal to human (interspecies). UFH = potential variation in 
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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 analyses 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

Acute (95th Percentile) Chronic Cancer

Estimated 

Exposure 

(mg/kg/day)

Estimated 

Risk, % 

aPAD

Estimated 

Exposure 

(mg/kg/day)

Estimated 

Risk, % 

cPAD

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 yrs 0.0637 64 0.00190 32

Youth 13-19 yrs 0.0559 56 0.00130 22

Adults 20-49 yrs 0.0605 61 0.00133 22

Adults 50+ yrs 0.0612 61 0.00173 29

Females 13-49 yrs 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 analysis can be characterized as highly health 

protective. While the application of the juice processing factor from grapes to other juices 

provides some refinement relative to a strict screening-level assessment, the conservatism in the 

other input parameters results in exposure estimates that are likely to overestimate actual dietary 

exposure.

As previously noted, the chronic assessment includes 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 produce 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. It is quite likely that monitoring data, 

which take these issues into account, would show significantly 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 type (table grapes). For all other crops, 

it was assumed that 100% of the planted acreage would be treated – a situation which is highly 
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unlikely. Overall, the chronic risk estimates are likely to be overestimates of actual chronic 

dietary risk.

VIII. Conclusions

Based on the results of these analyses, there are no dietary exposure considerations that would 

preclude granting the requested uses of tolfenpyrad. 

IX. List of Attachments

Attachment 1. Summary of Inputs for the Acute Dietary Risk Assessment for Tolfenpyrad.

Attachment 2. Summary of Inputs for the Chronic Dietary Risk Assessment for Tolfenpyrad.

Attachment 3. Summary of the Acute Dietary Analysis Results for Tolfenpyrad.

Attachment 4. Summary of the Chronic Dietary Analysis Results for Tolfenpyrad.

Attachment 5. Percent Crop Treated Memorandum from the Biological and Economic Analysis 

Division.
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Attachment 1. Summary of inputs for the acute dietary risk assessment for tolfenpyrad.

Filename: C:\Documents 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.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

01033001 1C Potato, tuber, 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 

08002711 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 Chayote, 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 1.000 
Tolfenpyrad 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 

09023570 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 Apple, 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 

11000110 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 Peach, 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 

12002870 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-babyfood 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 1.000 
Tolfenpyrad 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 Beef, 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 Beef, 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 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-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 1.000 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-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 

95001281 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 1.000 
Tolfenpyrad 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 tolfenpyrad.

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(Acute): .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

01033001 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, Chinese, 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 Kohlrabi 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 8.620000 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 Pepper, 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 

08003740 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-babyfood 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 Watermelon 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 

09023090 9B Pumpkin, seed 0.047000 1.000 1.000 

09023560 9B Squash, summer 0.047000 1.000 1.000 
Tolfenpyrad 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-babyfood 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 Orange, 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 

11000081 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-babyfood 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 Cherry, 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 

12002621 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-babyfood 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 Walnut 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 1.000 
Tolfenpyrad 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 Beef, 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 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 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-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 1.000 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-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 0.012200 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 Grape 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 From 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 1.000 
Tolfenpyrad Dietary Exposure and Risk Assessment DP Number: D398817

PC Code: 090111

Page 17 of 18

Attachment 3. Summary of the Acute Dietary Analysis Results for Tolfenpyrad.

U.S. Environmental Protection Agency Ver. 2.02

DEEM-FCID ACUTE Analysis 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 and 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 201.75 
Tolfenpyrad Dietary Exposure and Risk Assessment DP Number: D398817

PC Code: 090111

Page 18 of 18

Attachment 4. Summary of the Chronic Dietary Analysis Results for Tolfenpyrad.

U.S. Environmental Protection Agency Ver. 2.00

DEEM-FCID Chronic analysis for 090111 TOLFENPYRAD (1994-98 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.

Analysis 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 population 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 0.001726 28.8%

Females 13-49 yrs 0.001390 23.2%

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