Document ID: EPA-HQ-OPP-2012-0909-0004
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2013-11-19T05:00Z

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)

Executive Summary

Acute and chronic aggregate dietary (food and drinking water) exposure and risk assessments were conducted using the Dietary Exposure Evaluation Model DEEM-FCID(TM) (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 95[th] 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 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 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-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 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 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 procedure 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
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
  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

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)

  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 ug/L, respectively.  The maximum exposure estimate for ground water is 11 ug/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/.  

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-FCID(TM) 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 DEEM-FCID(TM), 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 food-form (e.g., orange or orange juice) on the food commodity residue list is multiplied by the average daily consumption estimate for that food/food form to produce a residue intake estimate.  The resulting residue intake estimate for each food/food form is summed with the residue intake estimates for all other food/food forms on the commodity residue list to arrive at the total average estimated exposure.  Exposure is expressed in mg/kg body weight/day and as a percent of the cPAD.  This procedure is performed for each population 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 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 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-FCID(TM) 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 (95[th] 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 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.

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  
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  
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  

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  
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  
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  
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 

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%

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