Cyflufenamid Dietary Exposure and Risk Assessment DP Number: 36455 9
PC Code: 555 550

______________________________________________________________________________________

Page 1 of 13 UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, D.C. 20460

OFFICE OF
CHEMICAL SAFETY
AND POLLUTION PREVENTION

MEMORANDUM

DATE: Ju l

- 20

- 2010

SUBJECT: Cyflufenamid : Chronic Aggregate Dietary (Food and Drinking Water) Exp osure an d Risk Assessments for the F irst F ood U ses in S upport of a Section 3 Registration Action on Cucurbit Vegetables (Crop Group 9), Pome Fruit (Crop Group 11), Small Fruit Vine Climbing Except Fuzzy Kiwifruit (Subgroup 13

- 07F), and Low Growing Berry ( Subgroup 13

- 07G )

, E xcept C ranberry

.

PC Code: 555550 DP Barcode: 36455 9
Decision No.: 4 03833 Registration No. : 8033

- RNG
Petition No.: 8 F 7488 Regulatory Action: Section 3 Registration Risk Assessment Type: Single Chemical Case No.: NA

T XR No.: NA CAS No.: 180409

- 60

- 3
MRID No.: NA 40 CFR: NA

REVIEWER : Meheret Negussie, Chemist Risk Assessment Branch III (RAB3) Health Effects Division (HED, 7509P)

THROUGH : Thurston Morton , Senior Chemist

Breann Hanson, Biologist Dietary Exposure Science Advisory Council (DESAC)/HED (7509P)

and

Paula Deschamp, Branch Chief
Risk Assessment Branch III /HED (7509P)

TO: Nancy Dodd

, Chemist, Risk Assessor
Risk Assessment Branch III /HED (7509P)

and

Marc Suarez, RM#11
Insecticide Branch/Registration Division (RD

, 7505P)Cyflufenamid Dietary Exposure and Risk Assessment DP Number: 36455 9
PC Code: 555 550

______________________________________________________________________________________

Page 2 of 13 Executive Summary

C hronic aggregate dietary (food and drinking water) exposure and risk assessments were
conducted for cyflufenamid using the Dietary Exposure Evaluation Model DEEM

- FCIDTM,
Version 2.03 which use s food consumption data from the U.S. Department of Agriculture’s Continuing Surveys of Food Intakes by Individuals (CSFII) from 1994

- 1996 and 1998. The analyses were performed to support Section 3 requests on cucurbit vegetables (Crop Group 9), pome fruits (Crop Group 11), small fruit vine climbing except fuzzy kiwifruit (Subgroup 13

- 07F), and low growing berry (Subgroup 13

- 07G) , except cranberry

. Cyflufenamid is a new active i ngredient; therefore

, this is the first dietary exposure

assessment

.

Acute Dietary Exposure Results and Characterization

No toxic effects attributable to a single exposure to cyflufenamid have been identified; therefore, an acute reference dose (aRfD) has not been established and an acute dietary exposure assessment was not conducted.

Chronic Dietary Exposure Results and Characterization

A partially refined chronic dietary assessment was conducted

. T he assumptions of this dietary assessment include d average field trial residue s for all proposed crops and 100% crop treated (CT)

. Empirical processing fa ctors were used for apple juice and grape juice.

A s eparate tolerance was set for grape

, raisin; therefore, the processing factor for this commodity was set at 1. For all other processed commodities, DEEM version 7.81 default processing factors were assumed. T he ground water e stimated drinking water concentration (EDWC ) value of 4.68 ug/L was incorporated directly into the dietary

assessment ( DP# 362 954 , R. Bohaty , 05/03/2010 )

.

The non

- cancer chronic dietary (food and drinking water) exposure to cyflufenamid is below HED’s level of concern [i.e., <100% Chronic Population Adjusted Doses (cPAD)] for the general U.S. population and all population subg roups. The chronic dietary exposure
estimates are <1% of the cPAD for the general U.S. population and was 1% to all infants (<

1 year old)

, the most highly exposed population subgroup. All other subgroups showed
estimates <1% of the cPAD.

Cancer Diet ary Exposure Results and Characterization

Cyflufenamid is a likely human carcinogen and requires a quantitative cancer risk

assessment

. The unit risk, Q 1 * = 6.61 X 10 - 3

, of c yflufenamid is based upon male mouse
liver combined adenoma and carcinoma tumor rates

. T he ground water EDWC (4.68 ug/L)

was incorporated into the dietary assessment (DP# 362954 , R. Bohaty , 05/03/2010 )

. The cancer dietary (food and drinking water) exposure estimate for the general U.S. population
is 9.51 x 10 - 7

, which is below HED’s level of concern ( 1 x 10 - 6 ).Cyflufenamid Dietary Exposure and Risk Assessment DP Number: 36455 9
PC Code: 555 550

______________________________________________________________________________________

Page 3 of 13 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 do se 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 o r safety factors.

For acute and non

- cancer chronic exposures, HED is concerned when estimated dietary risk
exceeds 100% of the PAD. References which discuss the acute and chronic risk assessments in more detail are available on the EPA/pesticides web sit e: “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 DEEM

- FCIDTM analysis conducted for cyflufenamid

.

II. Residue Information

Cyflufenamid (also designated as NF

- 149) is a new fungicidal active ingredient for the control of a wide range of powdery mildews on various crops. This plant dise ase is known to develop resistance to existing fungicides quite rapidly and new mode

- of

- action fungicides are continually needed by the growers. Cyflufenamid is an amidoxime or benzenacetamide containing a fluorinated aromatic ring and a cyclopropylmethox y group. Its biochemical mode of action has not yet been defined or classified. However, it is not cross resistant to strobilurines, quinoxyfen, triazoles, morpholines, or ethirimol resistant strains of powdery mildew.

The HED Residues of Concern Knowle dge

- based Subcommittee (ROCKS ) reviewed the plant, rotational crop, and livestock metabolism studies for cyflufenamid , as well as toxicological and environmental fate data, for determinat ion of the residues of concern

. The ROCKS concluded that in primary plants , the residue of concern is cyflufenamid ( Z

isomer ) for the purposes of tolerance and risk assessment ( DP# 377139, G. Kramer

, 05/ 18 / 20 10 ). RAB3 will confirm with the petitioner that the analytical enforcement method can, in fact, separate the E

- and Z

- isomers. If this is not the case, then the E

- isomer should be added to the tolerance expression.

The only livestock feedstuff associated with the proposed crop uses in this action is apple
wet pomace

. Based on t he results of the goat metabolism stud y and the calculated dietary burden there is no reasonable expectation of finite cyflufenamid residues in meat, milk, poultry and eggs as a result of the proposed uses. The residues of concern in ruminants is cyflufenamid ( Z

- isomer ), 2,3

- difluoro

- 6

- triflu oromethyl

- benzamidine (149

- F1), 2,3

- difluoro

- 6

- trifluoromethylbenzamide (149

- F6) , and cyclopropane carboxylic acid (CPCA)
for the purposes of risk assessments (ROCKS memo DP# 377139, 05/ 18 /2010 )

. Tolerances for ruminant commodities are not required at th is time. The re no poultry or swine feed items associated with the proposed uses.Cyflufenamid Dietary Exposure and Risk Assessment DP Number: 36455 9
PC Code: 555 550

______________________________________________________________________________________

Page 4 of 13 Residue information for the proposed food commodities included in the present analyses
was taken from the cyflufenamid residue chemistry memo (D P# 3 64556

, M. Negussie

, 07/ 01 / 2010 ).

T he chronic dietary analysis assumed average field trial residues for all proposed crops and
100% CT. Field trial data were translated from the representative commodities to the non

representative commodities according to HED SOP 2000.1:”Gui dance for Translation of Field Trial Data from Representative Commodities in the Crop Group Regulation to other Commodities in Each Crop Group/Subgroup.” Empirical processing factors for apple juice and g r ape juice were used. A s eparate tolerance was set for grape

, raisin; therefore, the processing factor for this commodity was set at 1. For all other processed commodities,
DEEM version 7.81 default processing factors were assumed.

Table 1 summarizes the cyflufenamid residue levels and processing fact ors for the proposed crops used in the chronic dietary assessments.

Table 1. Residue Data and Processing Factors used for C hronic Dietary Risk Assessment

. Commodity Residues (Average; ppm ) Processing Factors

Fruit, pome, group 11 Apple

- 0. 014

Pear

- 0.024 Apple, juice = 0.3

Vegetable, cucurbit, group 9 Cucumber

- 0.014 Cantaloupe

- 0.016 Squash Summer

0.02 2

Fruit, small vine climbing, subgroup 13

- 07F, except fuzzy kiwifruit Grape

- 0.037 Grape, juice = 0.2

Berry, low growing, subgroup 13

- 07G Str awberry

- 0.072 Grape, raisin 0.30 1 Grape, raisin = 1

1 Tolerance determined using processing study (HAFT

- highest average field trial residue x 3.6 (processing factor )

III. Drinking Water Data

The drinking water residues used in the dietary risk asses sment were provided by the Environmental Fate and Effects Division (EFED ; D P# 362954, R. Bohaty, 05/ 03/2 010 )

. Based on the modeling analysis performed for the proposed new uses, the estimated surface
water concentrations are 0.03 ug/L and 0.01 ug/L ( chro nic and cancer assessment, respectively ) and ground water concentration is not expected to be >4.68 ug/L. Typically

, HED uses the higher of the surface or groundwater estimates when assessing dietary risk ; therefore

, the ground water EDWC (4.68 ug/L) was used in the dietary assessment. W ater
residues were directly incorporated in the DEEM

- FCID into the food categories “water, direct, all sources” and “water, indirect, all sources.”

This drinking water assessment ( DWA ) takes into account cyflufenamid

, its isomer 149

- ( E )

- FB [( E )

- N

- (α

- Cyclopropylmethoxyimino

- 2,3

- difluoro

- 6

- trifluoromethylbenzyl)

- 2

- phenylacetamide], and four known degradation products of equal toxicological concern,
149

- F [ N

- Cyclopropylmethoxy

- 2,3

- difluoro

- 6

- trifluoro

- methylbenzamidine], 149

- F1 [2,3

-Cyflufenamid Dietary Exposure and Risk Assessment DP Number: 36455 9
PC Code: 555 550

______________________________________________________________________________________

Page 5 of 13 Difluoro

- 6

- triflu oromethylbenzamidine], 149

- F11 [( Z )

- N

- (α

- Cyclopropylmethoxyimino

2,3

- difluoro

- 6

- trifluoromethylbenzyl)carbamoyl acetic acid], and 149

- F6 [2,3

- Difluoro

- 6

- trifluoromethyl

- benzamide]. These compounds are referred to collectively as total toxic cyflufenamid r esidues.

Surface Water : Tier II EDWCs in surface water resulting from th e proposed uses of cyflufenamid on cucurbit vegetables, low growing berries, pome fruit, outdoor landscape and outdoor nursery ornamentals, and small fruit vines are calculated usin g PRZM ( P esticide R oot Z one M odel ) and EXAMS ( E x posure A nalysis M odeling S ystem,) models. Cyflufenamid applications to North Carolina apples provide the most conservative Tier II
EDWCs for total toxic residues

. Since the petitioner voluntarily withdrew the use on
cranberr ies

, the drinking water assessment conducted for cranberr ies was not included.

Tier II EDWCs for total toxic cyflufenamid residues on North Carolina apples are not expected to exceed 1.14 μg/L for the 1 in 10 year peak concentration, 0 .03 μg/L for the 1 in 10 year annual average concentration, and 0.01 μg/L for the 30 year annual average

, as summari z ed in Table 2

.

Table 2: Tier II PCA Corrected Surface Water EDWCs of Total Toxic Cyflufenamid Residues From the Proposed New Uses on C ucurbit Vegetables, Low Growing Berries, Ornamentals, Pome Fruit, and Small Climbing Fruit Vines and Tier I Surface Water EDWCs of Total Toxic Cyflufenamid Residues From the Proposed Use on Cranberry. Crop Scenario [application date (DD/MM)] Peak EDWC

μg /L (ppb) Yearly Mean μg/L 1
(ppb) Average of Yearly

Means 1

(ppb)

Pome Fruit Tier II: NC Apples (01/08) 1.14 0.03 0.01

Ground Water : Tier I groundwater EDWCs are estimated using S CI

- GROW ( S creening

C oncentration i n Gro und w ater ) for the proposed cyfluf enamid uses. Cyflufenamid application to low growing berries, ornamentals, pome fruits, and small fruit vines are not expected to result in groundwater concentrations > 4.68 μg/L for total toxic residues as

shown in Table 3 . Applications to cucurbit vege tables are expected to be lower than the
aforementioned uses.

Table 3: Tier I Groundwater EDWCs for Total Toxic Cyflufenamid Residues From the Proposed New Uses on Cucurbit Vegetables, Low Growing Berries, Ornamentals, Pome Fruit, and Small Climbing Fru it Vines. Crop Peak (ug/L)

Cucurbit Vegetables 2.34

Low Growing Berry, Ornamentals, Pome Fruit, and Small Climbing Fruit Vine 4.68 1

1 Bold font indicates highest value

IV. DEEM

- FCIDTM Program and Consumption Information

Cyflufenamid chronic dietary exposure assessment w as conducted using the DEEM

FCIDTM version 2.03 modeling software. It uses food consumption data from the U.S

.Cyflufenamid Dietary Exposure and Risk Assessment DP Number: 36455 9
PC Code: 555 550

______________________________________________________________________________________

Page 6 of 13 Department of Agriculture ( USDA ) CSFII 1994

- 1996 and 1998 food intake surveys

. 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. ap ples, 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. Based on analysis of the 1994

- 96, 98 CSFII consumption data, which took into account dietary patterns of survey respondents, HED concluded that it is most appropriate to report risk for the followin g 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 s , an estimate of the res idue 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 estim ate 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 c RfD . 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 b y 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
distributio n 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. I n 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 assessmen t.

V. Toxicological Information

HED evaluated the toxicology database for cyflufenamid and established the chronic
reference dose on 05/19/2 010

. To provide an overview of the toxicological profile, a summary of the doses and endpoints selected for the re le vant dietary exposure scenarios are provided in Table 4

.Cyflufenamid Dietary Exposure and Risk Assessment DP Number: 36455 9
PC Code: 555 550

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Page 7 of 13 Table 4 . Summary of Toxicological Doses and Endpoints for Cyflufenamid for Use in Dietary Human Health

Risk Assessments

.

Exposure/
Scenario Point of Departure Uncertainty/FQPA Safety Factor s RfD, PAD,
Level of
Concern for

Risk

Assessment Study and Toxicological Effects

Acute Dietary (General Population

, including

Infants and Children) N/A No hazard was identified.

N o o bserved effects were attribut able to a single dose.

Acute Dietary ( Females 13

- 49 years of age) N/A No hazard was identified.
No observed effects were attributable to a single dose.

Chronic Dietary (All Populations) NOAEL=

4.4 mg/kg/day UF A = 10x

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

= 0.044 mg/kg/day

cPAD =

0.044 mg/kg/d ay Combined Chronic Toxicity/ Carcinogenicity Study in Rats LOAEL = 22 mg/kg/day based on decreased body weight gain; increased thyroid/parathyroid weight, increased liver weight and centrilobular hepatocytic hypertrophy

. Cancer (oral, dermal, inhalation) Classification: Likely to be carcinogenic to humans Q 1 * = 6.61 x 10 - 3 (mg/kg/day) - 1

UF = uncertainty factor, UF A = extrapolation from animal to human (interspecies). UF H = potential variation in sensitivity among members of the human population (intras pecies ). FQPA SF = Special FQPA safety factor, NO A EL = no observed adverse effect level, LOAEL = lowest observed adverse effect level, cPAD = chronic population adjusted dose, Rfd = reference dose, N/A = not applicable.

VI. Results/Discussion

As stated above, for c hronic 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 5 are for the general U.S. Popula tion, 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.

Results of Chronic Dietary (Food and Drinking Water) Exposure Analysis

C hronic dietary risk a nalys e s were condu cted with the DEEM

- FCIDTM model to form a partially refined evaluation of exposure for cyflufenamid

. All chronic analys e s yield ed risk
estimates well below the 100% of the c PA D threshold level of concern for each population subgroup. For the general U

. S

. population , ch ronic aggregate dietary risk w as calculated at

<1 % of the cPA D with an exposure level of 0.00 0 144 mg/kg/day. For the subgroup with the highest calculated exposure, all infants (< 1 year old)

, chronic aggregate dietary risk occupied 1 % of the c PA D with an exposure of 0.0 0 0 423 mg/kg/day. The cancer dietary (food and drinking water) exposure estimate for the general U.S. population is 9.51 x 10 - 7

, which is below HED’s level of concern. An overview summarizing the results of theCyflufenamid Dietary Exposure and Risk Assessment DP Number: 36455 9
PC Code: 555 550

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Page 8 of 13 chronic dietary assessment

, w ith the population subgroup having the highest exposure being noted in bold

, is presented in Table 5

.

Table 5 . Summary of Dietary (Food and Drinking Water) Exposure and Risk for Cyflufenamid.

Population Subgroup

cPAD (mg/kg/day) Chronic Dietary Cancer

Dietary Exposure (mg/kg/day) %
cPAD Dietary Exposure (mg/kg/day) Risk

Q* = 6.61 x 10 - 3

General U.S. Population 0.2 0.000 144 <1 0.000 1 44 9.51 x 10 - 7

All Infants (< 1 year old) 0.2 0.000 423 1 1

NA 2 NA Children 1

- 2 years old 0.2 0.000330 <1

Childr en 3

- 5 years old 0.2 0.0002 71 <1

Children 6

- 12 years old 0.2 0.000 157 <1

Youth 13

- 19 years old 0.2 0.000 097 <1

Adults 20

- 49 years old 0.2 0.000 121 <1

Adults 50+ years old 0.2 0.000 136 <1

Females 13

- 49 years old 0.2 0.000 123 <1

1 The population subgroup with the highest estimated chronic dietary (food + drinking water) exposure and risk is indicated by bold text.

2 NA = not applicable

VII. Characterization of Inputs/Outputs

The chronic dietary assessment for cyflufenamid is a partiall y refined analysis

. The analysis assumed average field trial residues

, default/e mpirical processing factors (apples and grapes)

, 100% crop treated

, and conservative EDWCs derived through EFED modeling
which are unlikely to underestimate the concentration of cyflufenamid in drinking water
were utilized

. ( Refinements were made to upper bound exposure estimates specifically for
use in the cancer assessment ). For these reasons, it can be concluded that the DEEM

FCIDTM analysis does not underestimate risk from chronic exposure to cyflufenamid for the general U.S. population and all its subgroups. Additional refinements may include %CT
estimates and processing factors ; however, the refinements are not necessar y at this time.

VIII. Conclusions

The partially refined chronic dietary risk assessment indicates that exposures to cyflufenamid are below HED’s level of concern. The non

- cancer chronic dietary (food and drinking water) exposure estimates are <1% of th e cPAD for the general U.S. population
and was 1% to all infants (< 1 year old) , the most highly exposed population subgroup. All other subgroups showed estimates <1% of the cPAD.

The cancer dietary (food and drinking water) exposure estimate for the gen eral U.S.Cyflufenamid Dietary Exposure and Risk Assessment DP Number: 36455 9
PC Code: 555 550

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Page 9 of 13 population is 9.51 x 10 - 7

, which is below HED’s level of concern. Therefore , HED is not concerned that the proposed new uses of cyflufenamid could result in unacceptable risk through the potential chronic dietary exposure from food and water sou rces.

IX. List of Attachments

Attachment 1

. Cyflufenamid Chronic /Cancer Dietary Analysis Input File

- Food & Water

. Attachment 2

. Cyflufenamid Chronic Dietary Analysis Results

- Food & Water

. Attachment 3

. Cyflufenamid Cancer Dietary Analysis Resul ts

- Food & WaterCyflufenamid Dietary Exposure and Risk Assessment DP Number: 36455 9
PC Code: 555 550

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Page 10 of 13 Attachment 1

. Cyflufenamid Chronic /Cancer Dietary Analysis Input File

- Food &

Water

.

U.S. Environmental Protection Agency Ver. 2.00

DEEM

- FCID Chronic analysis for CY FLUFENAMID 1994

- 98 data
Residue file: C: \ Documents and Settings \ MNEGUSSI \ My

Documents \ DEEMFCID \ Cyflufenamid \ CancerCyflufenamid_avggroundwater.R98 Adjust. #2 NOT used Analysis Date 07

- 20

- 2010 Residue file dated: 07

- 20

- 2010/09:32:48/8 Reference dose (RfD) = 0.044 mg/kg bw/day Comment:cancer; ground water; avg, Cucrbit Vegetables (9), Avf apple/grape inc PF Pome Fruits (11), Small Fruit Vine ex fuzzy kiwi (13

- 07F), Low Growing Berries (13

- G)

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

-------- ---- ------------------------------- ---------- ------ ------ ------- 11000070 11 Apple, fruit with peel 0.014000 1.000 1.000 AVG FT

Full c omment: AVG FT MRID 47638213 11000080 11 Apple, peeled fruit 0.014000 1.000 1.000 AVG FT

Full comment: AVG FT MRID 47638213 11000081 11 Apple, peeled fruit

- babyfood 0.014000 1.000 1.000 AVG FT

Full comment: AV G FT MRID 47638213 11000090 11 Apple, dried 0.014000 8.000 1.000 AVG FT

Full comment: AVG FT MRID 47638213 11000091 11 Apple, dried

- babyfood 0.014000 8.000 1.000 AVG FT

Full comment: AVG FT MRID 47638213 11000100 11 Apple, juice 0.014000 0.300 1.000 AVG FT

Full comment: AVG FT MRID 47638213 11000101 11 Apple, juice

- babyfood 0.014000 0.300 1.000 AVG FT

Full comment: AVG FT MRID 47638213

1 1000110 11 Apple, sauce 0.014000 1.000 1.000 AVG FT

Full comment: AVG FT MRID 47638213 11000111 11 Apple, sauce

- babyfood 0.014000 1.000 1.000 AVG FT

Full comment: AVG FT MRID 47638213

09020210 9B Balsam pear 0.014000 1.000 1.000 AVG MR

Full comment: AVG MRID 47620816 13020570 13B Blueberry 0.072000 1.000 1.000 AVG MR

Full comment: AVG MRID 47620818 13020571 13B Blueberry

- bab yfood 0.072000 1.000 1.000 AVG MR

Full comment: AVG MRID 47620818 09010750 9A Cantaloupe 0.016000 1.000 1.000 AVG MR

Full comment: AVG MRID 47620816

09010800 9A Casaba 0.016000 1.000 1.000 AVG MR

Full comment: AVG MRID 47620816 09020880 9B Chayote, fruit 0.022000 1.000 1.000 AVG MR

Full comment: AVG MRID 47620816 09021020 9B Chinese waxgourd 0.014000 1.000 1.000 AVG MR

Full comment: AVG MRID 47620816 11001290 11 Crabapple 0.014000 1.000 1.000 AVG FT

Full comment: AVG FT MRID 47638213

09021350 9B Cucumber 0.014000 1.000 1 .000 AVG MR

Full comment: AVG MRID 47620816 95001750 O Grape 0.037000 1.000 1.000 AVG FT

Full comment: AVG FT MRID 47620817 95001760 O Grape, juice 0.037000 0.200 1.000 AVG FT

Full comment: AVG FT MRID 47620817 95001761 O Grape, juice

- babyfood 0.037000 0.200 1.000 AVG FT

Full comment: AVG FT MRID 47620817 95001770 O Grape, leaves 0.037000 1.000 1.000 AVG FT

Full co mment: AVG FT MRID 47620817 95001780 O Grape, raisin 0.300000 1.000 1.000 FT MRI

Full comment: FT MRID 47620817 95001790 O Grape, wine and sherry 0.037000 1.000 1.000 FT MRI

Full comment: FT MRID 47620817 09011870 9A Honeydew melon 0.016000 1.000 1.000 AVG MR

Full comment: AVG MRID 47620816Cyflufenamid Dietary Exposure and Risk Assessment DP Number: 36455 9
PC Code: 555 550

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Page 11 of 13 11002100 11 Loquat 0.024000 1.000 1.000 AVG FT

Full comment: AVG FT MRID 47638213

110 02660 11 Pear 0.024000 1.000 1.000 AVG FT

Full comment: AVG FT MRID 47638213

11002661 11 Pear

- babyfood 0.024000 1.000 1.000 AVG FT

Full comment: AVG FT MRID 47638213

11002670 11 Pear, dried 0.024000 6.250 1.000 AVG FT

Full comment: AVG FT MRID 47638213 11002680 11 Pear, juice 0.024000 1.000 1.000 AVG FT

Full comment: AVG FT MRID 47638213 11002681 11 Pear, jui ce

- babyfood 0.024000 1.000 1.000 AVG FT

Full comment: AVG FT MRID 47638213 09023080 9B Pumpkin 0.022000 1.000 1.000 AVG MR

Full comment: AVG MRID 47620816 09023090 9B Pumpkin, seed 0.022000 1.000 1.000 AVG MR

Full comment: AVG MRID 47620816 11003100 11 Quince 0.024000 1.000 1.000 09023560 9B Squash, summer 0.022000 1.000 1.000 AVG MR

Full comment: AVG MRID 47620816 09023561 9B Squash, summer

- babyfood 0.022000 1.000 1.000 AVG MR

Full comment: AVG MRID 47620816 09023570 9B Squash, winter 0.022000 1.000 1.000 AVG MR

Full comment: AVG MR ID 47620816 09023571 9B Squash, winter

- babyfood 0.022000 1.000 1.000 AVG MR

Full comment: AVG MRID 47620816 95003590 O Strawberry 0.072000 1.000 1.000 AVG MR

Full comment: AVG MRID 47620818

9500 3591 O Strawberry

- babyfood 0.072000 1.000 1.000 AVG MR

Full comment: AVG MRID 47620818 95003600 O Strawberry, juice 0.072000 1.000 1.000 AVG MR

Full comment: AVG MRID 47620818

95003601 O Strawb erry, juice

- babyfood 0.072000 1.000 1.000 AVG MR

Full comment: AVG MRID 47620818 86010000 O Water, direct, all sources 0.004680 1.000 1.000 86020000 O Water, indirect, all sources 0.004680 1.000 1.000

09013990 9A Watermelon 0.016000 1.000 1.000 AVG MR

Full comment: AVG MRID 47620816 09014000 9A Watermelon, juice 0.016000 1.000 1.000 AVG MR

Full comment: AVG MRID 47620816Cyflufenamid Dietary Exposure and Risk Assessment DP Number: 36455 9
PC Code: 555 550

______________________________________________________________________________________

Page 12 of 13 Attachment 2

. Cyflufenamid Chronic Dietary Analysis Results File

- Food &

Water

.

U.S. Environmental Protection Agency Ver. 2.00

DEEM

- FCID Chronic analysis for CYFLUFENAMID (1994

- 98 data)
Resi due file name: C: \ Documents and Settings \ MNEGUSSI \ My

Documents \ DEEMFCID \ Cyflufenamid \ CancerCyflufenamid_avggroundwater.R98 Adjustment factor #2 NOT used. Analysis Date 07

- 20

- 2010/09:42:00 Residue file da ted: 07

- 20

- 2010/09:32:48/8 Reference dose (RfD, Chronic) = .044 mg/kg bw/day COMMENT 1: cancer; ground water; avg, Cucrbit Vegetables (9), Avf apple/grape inc PF Pome Fruits (11), Small Fruit Vine ex fuzzy kiwi (13

- 07F), Low Growing Berries (13

- G)

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

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

Total Exposure

----------------------------------- Population mg/kg Percent of

Subgroup body wt/day Rfd

--- ----------------------------------- ------------- --------------- U.S. Population (total) 0.000144 0.3%

U.S. Population (spring season) 0.000146 0.3% U.S. Population (summer season) 0.000158 0.4% U.S. Population (autumn season) 0.000137 0.3% U.S. Population (winter season) 0.000136 0.3%

Northeast region 0.000140 0.3% Midwest region 0.000145 0.3% Southern region 0.000132 0.3% Western region 0.000167 0.4%

Hispanics 0.000152 0.3%

Non

- hispanic whites 0.000145 0.3%

Non

- hispanic blacks 0.000125 0.3%

Non

- hisp/non

- white/non

- bla ck 0.000170 0.4%

All infants (< 1 year) 0.000423 1.0% Nursing infants 0.000184 0.4%

Non

- nursing infants 0.000514 1.2%
Children 1

- 6 yrs 0.000281 0.6%
Children 7

- 12 yrs 0.000148 0.3%

Females 13

- 19 (not preg or nursing) 0.000095 0.2% Females 20+ (not p reg or nursing) 0.000134 0.3%

Females 13

- 50 yrs 0.000129 0.3% Females 13+ (preg/not nursing) 0.000132 0.3% Females 13+ (nursing) 0.000190 0.4%

Males 13

- 19 yrs 0.000099 0.2% Males 20+ yrs 0.000117 0.3%
Seniors 55+ 0.000137 0.3%

Children 1

- 2 yrs 0.000330 0.8%
Children 3

- 5 yrs 0.000271 0.6%
Children 6

- 12 yrs 0.000157 0.4%

Youth 13

- 19 yrs 0.000097 0.2%

Adults 20

- 49 yrs 0.000121 0.3% Adults 50+ yrs 0.000136 0.3%

Females 13

- 49 yrs 0.000123 0.3%

--- ----------------------------------------------------------------------------Cyflufenamid Dietary Exposure and Risk Assessment DP Number: 36455 9
PC Code: 555 550

______________________________________________________________________________________

Page 13 of 13 Attachment 3

. Cyflufenamid C ancer Dietary Analysis Results File

- Food &

Water

. U.S. Environmental Protection Agency Ver. 2.00

DEEM

- FCID Chron ic analysis for CYFLUFENAMID (1994

- 98 data)
Residue file name: C: \ Documents and Settings \ MNEGUSSI \ My

Documents \ DEEMFCID \ Cyflufenamid \ CancerCyflufenamid_avggroundwater.R98 Adjustment facto r #2 NOT used. Analysis Date 07

- 20

- 2010/09:34:05 Residue file dated: 07

- 20

- 2010/09:32:48/8
Q* = 0.0066 COMMENT 1: cancer; ground water; avg, Cucrbit Vegetables (9), Avf apple/grape inc PF Pome Fruits (11), Small Fruit Vine ex fuzzy kiwi (13

- 07F), Low Growing Berries (13

- G)

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

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

Total Exposure

----------------------------------- Population mg/kg Lifetime risk

Subgroup body wt/day (Q*= .0066)

-------------------------------------- ------------- ------------- U.S. Population (total) 0.000144 9.51E

- 07