UNITED STATES ENVIRONMENTAL PROTECTION AGENCY



### M EM ORAND U M

DA TE: 1O-November-2015 WASHINGTON

, D.C. 20460

OHICE OF C ll O ll C. \L S ,\ FE " I \

. \:\D r ou

. rT10'\' r1 u : n : Yr10"

SUBJ E CT: 

### C lof e nt cz in e

. Chronic and Cancer Dietary (Food and Drinking Water) Exposure

Asse s sm e nt s in Supp o rt o f E s tabli s hm e nt of Permanent Tolerances and Sect i on 3 Registration for New Use on Avocado and Papaya and Crop Group / Subgroup

E xpansions fo r Pome Frnit

, Group 11-1 O; C herry Subgroup 1 2-12A ; P eac h

S ub g roup l 2-12B and Fruit , s mall

, vine climbing

, except fu zz y kiwi

, Subgroup

13-07F.



### P C Co d e: 125501 

### DP Bar co d e: D429749



### Deci s ion No.: 495217 

### R eg i s tr a tion No.: 7602-1



### P et ition No

. : NA 

### Re g ul a tory Act i on: Sect i on 3 R e g i stration



### Risk Assess m e nt Typ e : Di e tar y A s se ss ment 

### Case No.: N A



### TXR No.: NA 

### CAS No. : 95266-40-3



### MRID No.: NA 40 

### CF R: 180.446

REVIEWER: P. Y v onne B a rne s, Chemi s t

# Jf1~--;e:::>~ Risk As s essment Branch ( RABV I )

Health E ffect s Division (HED

, 7509P )

THROUGH: Jd eli z Encarnacion

,

# Chemi**~** C...----

Donald W il bur

, Chemist 

# /lJ/

Dietar y Ex p os ure Sci e nc e Ad v isor y Council (DES A C)

Health Effect s Di v isi o n (HED

, 7509P )

and

Donna 

## s

. Da v is , A cting C hief 

# n O A(\ '\

. Risk As se ssment Branch ( RAB V I )

## ~**~** H ealt h Effects Division (HE D. 7509P)

TO: Ev isabel Craig

, Toxico l ogi s t and Ri s k A ss e ss or
Risk As s essment Branch VI

Health E ffect s Di v isi o n ( HED 7509P )

and

Andrew E rtman / Barbara Madden

, RM 05

Risk I nt e grat i on
, Min o r Us e, Emergency Response Branch Regi s tration Divi s ion ( RD ; 7505P )Clofentezine Dietary Exposure Assessment DP Number: D429749

PC Code: 125501 Page 2 of 20



### Executive Summary

Chronic and cancer aggregate dietary food and drinking wate r exposure and risk assessments were conducted using the Dietary Exposure Evaluation Mode l software with the Food Commodity Intake Database ( DEEM

- FCID ) , Version 3.16

. This software uses 2003

- 2008 food consumption data from the U.S. Department of Agriculture’s (USDA’s) National Health and Nutrition Examination Survey, What We Eat in America, (NHANES/WWEIA). These analyses

were conducted in support of a human

- health risk assessmen t for the proposed Section 3 uses of

Clofentezine on a vocado and p apaya and c rop g roup/ s ubgroup e xpansions for p ome f ruit, g roup 11

- 10 ; c herry s ubgroup 12

- 12A

, p each s ubgroup 12

- 12B

, and f ruit, small, vine climbing, except fuzzy kiwi, s ubgroup 13

- 07F

. This memorandum was reviewed by two peer reviewers of the DESAC, per DESAC SOP 2012.1.

The chronic and cancer analyses incorporated anticipated residues (average residues from available field trial data) for all registered and proposed commodities and latest percent crop treated (% CT) available. The highest estimated drinking water concentr ations (EDWCs) of

clofentezine were provided by the Environmental Fate and Effects Division (EFED) and incorporated directly into the chronic and cancer assessment s . The drinking water assessment

was based on the previously registered use of clofentezine o n apples

.

Chronic Dietary (Food and Drinking Water) Exposure Results and Characterization The chronic dietary (food and water) exposure from the existing and proposed uses results in an

estimated risk of < 1% of the chronic population adjusted dose (cPAD) for the general U.S. population and all population s subgroups . Chronic risk from the dietar y (food and water)

exposure to clofentezine is not of concern (less than 100%) for the general U.S. population and any population subgroup.

Cancer Dietary (Food and Drinking Water) Exposure Results and Characterization

Clofentezine has been classified as a possible human carcinogen. Applying the Q 1 

### * of 0.0376 (mg/kg/day)

- 1 

### to the exposure value result s in a cancer risk estimate of 3

. 8 x 10

- 7



### .

I. Introduction

Clofentezine (3,6

- bis (2

- chlorophenyl)

- 1,2,4,5

- tetrazine) is an acaricide that is used in plant protection products for the control of spider mites

. It acts primarily as an ovicide, but it has some activity against early motile stages of mites. Clofentezine is formulated as a suspension

concentrate. Two end

- use products are registered: Apollo ® 

### SC Ov icide/Miticide and Clofentezine SC. There are no registered residential uses for clofentezine.

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 that HED has concluded will result in no unreasonable adverse health effects). This dose is referred to as the population

- adjusted dose (PAD). The PAD is equivalent to the point of departure (P o D, NOAEL, LOAEL , e.g.) divided by the required uncertainty or safety

factors.Clofentezine Dietary Exposure Assessment DP Number: D429749

PC Code: 125501 Page 3 of 20



### For acute and non

- cancer chronic exposures, HED is concerned when estimated dietary risk

exceeds 100% of the PAD. References that 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.re gulations.gov/#!documentDetail;D=EPA

- HQ

- OPP

- 2007

- 0780

- 0001 ; or see SOP 99.6 (20

- AUG

- 1999).

The most recent dietary risk assessment for clofentezine was c onducted by S

. Piper ( 06/06/ 2013

, D404436 ).

II. Residue Information

Clofentezine is a n insecticide/ miticide used on various crops and ornamentals. Tolerances are currently established under 40 CFR §180.446 for the residues of clofentezine on the following raw agricultural commodities (RACs): almond hulls (5.0 ppm), almonds (0.5 0 ppm), apple pomace (3.0 ppm ), apricot (1.0 ppm), walnut (0.02 ppm) and persimmon (0.02 ppm)

. Tolerances are also established for the combined residues of clofentezine and the 3

- (2

- chloro

- 4

- hydroxyphenyl)

- 6

- (2

- chlorophenyl)

- 1, 2, 4, 5

- tetrazine metabolite (calculated in parent

e quivalents) in or on the following livestock commodities: cattle, goat, hog, horse, sheep and milk. The tolerance levels are 0.05 ppm on fat, meat, and meat byproducts, 0.4 ppm on liver, and 0.01 ppm on milk. T olerances are established for clofentezine for the group/ subgroups expansions based on an existing tolerance for individual representative commodities: p ome f ruit

g roup 11

- 10 ( 0.50 ppm); c herry s ubgroup 12

- 12A ( 1.0 ppm); peach s ubgroup 12

- 12B (1.0 ppm);

and f ruit, small, vine climbing, except fuzzy k iwi s ubgroup 13

- 07F (1.0 pp m)

. No new crop

field trial data were submitted n or are any required because the existing residue data are adequate to support the petitioned actions. A tolerance summary is provide in Table 1.

IR

- 4 petitioned to translate the available data from avocado to papaya. This proposal was brought to the ChemSAC. The ChemSAC determined that the translation of avocado data to papaya was appropriate, provided the number of field trials and geographical lo cations was adequate (ChemSAC 07/30/2014). A new tolerance is proposed and recommended for avocado (0.30 ppm) and translated to papaya (0.3 0 ppm).

The residue of concern in the registered plant commodities for risk assessment purposes is the parent, clofentezine only. For ruminants , the residues of concern for risk assessment are the

combined residues of the parent, clofentezine, and the 3

- (2

- chloro

- 4

- hydroxyphenyl)

- 6

- (2

- chlorophenyl)

- 1,2,4,5

- tetrazine me tabolite

. (Memo, M. Bradley, 08/03/ 19 89; DEB Nos. 5367 and 5371). There are new ruminant feed items associated with the petition.Clofentezine Dietary Exposure Assessment DP Number: D429749

PC Code: 125501 Page 4 of 20



### Table 1. T olerance Summary for Clofentezine

Commodity Proposed

Tolerance (ppm) Recommended

Tolerance (ppm) Correct Commodity

Definition/Comments

To be established under 40 CFR §180.446 (a) General. (1) Cherry, subgroup 12

- 12A 1.0 1.0 Established tolerance for cherry (1.0 ppm) should be removed from the 40CFR and replaced by this subgroup tolerance.
Fruit, pome, group 11

- 10 0.5 0.50 Established tolerance for apple and pear (0.5 ppm) should be

removed from 40CFR and replaced by this group

tolerance. Peach, subgroup 12

- 12B 1.0 1.0 Established tolerance for peach

should be removed from the 40CFR and replaced by this group tolerance. Fruit, small, vine climbing, except fuzzy kiwifruit, Subgroup 13

- 07F 1.0 1.0 Established tolerance for grape (1 ppm) should be removed from the 40CFR and replaced by this subgroup tolerance.

Avocado 0.3 0.30 Papaya 0.3 0.30

Anticipated residues (ARs):

J. Rowell, D252865, 02/17/1999 S. Piper

, D404436, 06/06/2013



### Average crop field trial residues and secondary residues in livestock were previously calculated to support registration on several crops. The AR values for c attle, goat, horses, pork and shee p are higher than what would be calculated with current practices. Average crop field trial residues

calculated for the avocado is translated to the papaya. These values were incorporated into the

current assessment ( Table 2 )

.

Processing Factors :
J. Carroll, D296126; 09/15/2004; MRID 45080704



### Available empirical processing factors were used for register ed commodities when available

. Default DEEM  Version 7. 81 processing factors were used for all other registered process ed

commodities ( Table 2 )

.Clofentezine Dietary Exposure Assessment DP Number: D429749

PC Code: 125501 Page 5 of 20



### Table 2

Data and Residue Estimates Used in DEEM

- FCID Chronic and Cancer Dietary Analyses

Commodity Food Forms %CT 1 

### Processing Factors Anticipated Residue (AR)

Estimates 2



### Avocado all

- - AR 0.087 ppm

Papaya all

- Dried papaya = default (1.8) Papaya juice = default (1.5) AR 0.087 ppm

Almond all <5

- AR 0.09 ppm

Apple all <2.5 dried apple = default (8.0) apple juice = 0.105 AR 0.12 ppm

Apricot all <2.5 dried apricot = default (6.0) AR 0.44 ppm

Cherry all 5 cherry juice = default (1.5) AR 0.19 ppm

Livestock * 

### meat

- dried beef = default (1.92) AR 0.00004 ppm

m eat byproducts

- - AR 0.006 ppm

fat

- - AR 0.0004 ppm

kidney

- - AR 0.001 ppm

liver

- - AR 0.006 ppm

Grape all <1 raisins = 0.3 grape juice = 0.09 AR 0.14 ppm

Milk all

- - AR 0.0003 ppm

Nectarine all 5

- AR 0.12 ppm

Peach all 5 dried peach = default (7.0) AR 0.13 ppm

Pear all 5 dried pear = default (6.25) pear juice = 0.105 AR 0.15 ppm

Persimmon all 100

- AR 0.024 ppm

Walnut all 5

- 0.02 ppm

1 . %CT estimates were used for the chronic and cancer assessment.

2 . Anticipated Residues (ARs) are the average field trial residues. * Cattle, goat, horses, pork and sheep.Clofentezine Dietary Exposure Assessment DP Number: D429749

PC Code: 125501 Page 6 of 20



### III

. Percent Crop Treated Information

J. Alsadek, D424398, 12/12/2014



### T he Biological and Economics Analysis Division (BEAD) provided updated estimated % CT

information for several commodities ( Attachment 4 )

. The average percent crop treated estimates were used in the chronic and cancer dietary risk assessments for the following crops that are currently registered for clofentezine: almonds: 5 %; apples: 2.5%; apricots: 2.5%; cherries: 5%; grapes: 1%; nectarines : 5%; peaches 5%; pears 5%; and walnuts: 5%.

IV. Drinking Water Data

Reference: U.S. EPA. 2012. Clofentezine Drinking Water Assessment for Application to Almonds, Apples, Apricots, Christmas Trees, Nectarines, Containerized Plants, Peaches, Pears, Persi mmons, Pecans, and Walnuts. Environmental Fate and Effects Division. DP 404287, August 3, 2012.



### The same drinking water assessment for clofentezine conducted in 2012 is appropriate to
support new uses. This assessment was used to support new uses on papaya and avocado since

based on communication with EFED (D 423336, R. Louie

- Juzwiak, May 27, 2015) a new drinking water assessment is not needed . T he residues of concern for clofentezine in drinking

water is clofentezine

. A Tier II Estimated Drinking Water Concentrations (EDWCs) were generated to support clofentezine use on almonds, apples, Christmas trees, nectarines, containerized plants, peaches, pears, pecans, persimmons and walnuts. T he surface water

EDW Cs are based on the USEPA Pesticide Root Zone Model (PRZM) and Exposure Analysis Modeling System (EXAMS) using the EXPRESS shell , Version 1.03.02 . The highest surface water EDWCs values are 7.59 ppb (1

- in

- 10 year acute) and 0.062 ppb (1

- in

- 10 year annual

a verage). These concentration values were produced by the EFED North Carolina apple

scenario and corrected for the required 100 buffer. The SCI

- GROW groundwater concentration

is 0.04 1 ppb.

Water residues were incorporated directly in the DEEM

- FCID into the food categories “water, direct, all sources” and “water, indirect, all sources.” The model and its description are

available at the EPA internet site: http://www.epa.gov/op pefed1/models/water/.

Table 3 : Maximum Estimated Surface Water and Groundwater Concentrations for Clofentezine

Drinking Water Source Model Use rate (lbs a

. i/A/season) Acute (ppb) Chronic

(ppb)

Parent only

Surface water FIRST

0.2 6 7.59 1 0.062 2

Groundwater SCI

- GROW

-- 0.041

Note: Bolded value was used for the chronic dietary assessment.

1 Represents North Carolina apple scenario

2 Represents California grape scenarioClofentezine Dietary Exposure Assessment DP Number: D429749

PC Code: 125501 Page 7 of 20



### V. DEEM  Program and Consumption Information

Clofentezine chronic and cancer dietary exposure assessments were conducted using the DEEM

FCID, Version 3.16, which incorporates 2003

- 2008 consumption data from USDA’s NHANES/WWEIA. The data are based on the reported consumption of more than 20,000

indivi duals 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 r ecipe 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. However, for acute exposure assessment, consumption data are reta ined as individual consumption events. Based on analysis of the 2003

- 2008 WWEIA 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 subgro ups: 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

- 99 years old.

For a chronic dietary exposure assessment, an estimate of the residue level in ea ch 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 foo d/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 proced ure is performed for each population subgroup.

V I

. Toxicological Information

The HED Hazard Identification Assessment Review Committee (HIARC) met on January 0 7, 1999 to determine endpoint selection for clofentezine. At this meeting, the HIARC also evaluated the potential for increased susceptibility of infants and children from exposure to clofentezine as required by the FQPA of 1996 (TXR No. 0052497). The HED Cancer Peer Review Committee (CPRC) met in June of 1988, July of 1988 and April of 1990 an d classified clofentezine as a possible human carcinogen (classification of C). The cancer risk was quantified using a linear low dose extrapolation method based upon male rat thyroid follicular cell ade n o m a and/or carcinoma combined tumor rates . Table 4 i s a summary of the decisions made by the HIARC concerning dietary exposure assessment.Clofentezine Dietary Exposure Assessment DP Number: D429749

PC Code: 125501 Page 8 of 20

Table 4

. Summary of Clofentezine Toxicological Doses and Endpoints for Use in Human Risk Assessment 1

Exposure

Scenario Point of

Departure (PoD) (mg/kg/day) Uncertainty/FQPA

Safety Factors RfD, PAD, Level of

Concern for Risk

Assessment Study and Toxicological

Effects

Acute Dietary No appropriate endpoint was identified in oral toxicity studies including the developmental studies

in rats and rabbits for risk assessment because no adverse effects were associated with a single

clofentezine dose.

Chronic Dietary NOAEL = 1.25 UF A =10x

UF H =10x FQPA SF=1x Chronic RfD= 0.013

cPAD= 0.013 1

- year chronic dog study

LOAEL = 25 mg/kg, based on increased liver weights,

h epatocellular enlargement,

and increased serum cholesterol, triglycerides and alkaline phosphatase levels
Cancer (oral, dermal, inhalation) Classification: possible human carcinogen (classification of C), Q* using the 3⁄4 interspecies scaling

factor is 3.76 x 10

- 2 (mg/kg/day)

- 1

1 Explanation of Abbreviations: 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 en vironmentally relevant human exposures. NOAEL = no observed adverse effect level. LOAEL = lowest observed adverse effect le vel. UF = uncertainty factor. UF A = extrapolation from animal to human (interspecies). UF H = potential variation in sensitivity among members of the human population (intraspecies). FQPA SF = FQPA Safety Factor. PAD = population adjusted dose (a = acute, c = chronic). RfD = reference dose.



### V I I. Results/ Discussion

As stated above, for 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 5 are for the general U.S. Population, all infants (<1 year old), childr en 1

- 2, children 3

- 5, children 6

- 12, youth 13

- 19,

females 13

- 49, adults 20

- 49, and adults 50

- 99 years. Cancer risk is determined for the general U.S. population only.

The results of the chronic and cancer dietary exposure analyses are reported in the summ ary
T able 5.

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

Population Subgroup

cPAD (mg/kg/day) Chronic Dietary 

### Cancer

Dietary Exposure (mg/kg/day) %

cPAD 

### Dietary

Exposure (mg/kg/day) Risk

Q* = 3. 76 x 10

- 2

General U.S. Population 

### 0.00010 <1 

### 0.00 0 0 10 3

. 8 x 10

- 7

All Infants (< 1 year old) 

### 0.000029 <1Clofentezine Dietary Exposure Assessment DP Number: D429749

PC Code: 125501 Page 9 of 20

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

Population Subgroup

cPAD (mg/kg/day) Chronic Dietary 

### Cancer

Dietary Exposure (mg/kg/day) %

cPAD 

### Dietary

Exposure (mg/kg/day) Risk

Q* = 3. 76 x 10

- 2

Children 1

- 2 years old 0.013 

### 0.000039 <1

Children 3

- 5 years old 

### 0.000024 <1

Children 6

- 12 years old 

### 0.000013 <1

Youth 13

- 19 years old 

### 0.000006 <1

Adults 20

- 49 years old 

### 0.000008 <1

Adults 50

- 99 years old 

### 0.000008 <1

Females 13

- 49 years old 

### 0.000008 <1



### V I II. Characterization of Inputs/Outputs

The previous preliminary assessment of the cancer risk for the U.S. population was found to

exceed 1 .0 x 10 - 6



### . In order to further refine the cancer risk, the DEEM analysis was partially refined, incorporating % crop treated data and/or anticipated residues (ARs) for all commodities as appropriate. The ave rage field trial value from the crop field trials was used for all crops. However, only apple pomace was used to calculate the anticipated dietary burden as both of these items are regional in nature and using apple pomace result ed in higher dietary burde n. T he highest dosing levels used in the ruminant feeding study (100 ppm) corresponding to an anticipated dietary burden for beef at 0.17 ppm (588X) and dairy cattle at 0.084 ppm ( 1190X ). Based on this information, and based on the residues found in meat, meat by

- products, fat and milk, the anticipated residues in livestock commodities were determined that would be used in the chronic dietary risk assessments (Table 2)

.

The avocado AR value translated to papaya was also determine using the same method us ed to

calculate crop AR’s. The chronic and cancer assessments were refined, using ARs for all registered and proposed uses, %CT information for all registered RACs. Available empirical processing factors were used for registered commodities. Default DEEM  Version 7. 81 processing factors were used for all other registered processed commodities. A more highly refined analysis is not needed at this time, since the chronic risk estimates are well below HED’s

level of concern.Clofentezine Dietary Exposure Assessment DP Number: D429749

PC Code: 125501 Page 10 of 20



### IX

. Conclusions

R efined (using anticipated residues for all registered and proposed commodities and %CT) chronic and cancer dietary exposure assessments were conducted for the general U.S. population and various population subgroups using and DEEM

- FCID  

### (Version 3.16) whic h uses food consumption data from the NHANES/WWEIA. T he resulting chronic dietary risk estimates are not of concern ( less than 100% cPAD) for the general U.S. population and all population subgroups (<1% cPAD). Applying the Q 1 

### * of 0.0376 (mg/kg/day)

- 1 

### to t he exposure value results

in a cancer risk estimate of 3

. 8 x 10

- 7



### .

X

. List of Attachments

Attachment 1. Clofentezine Chronic and Cancer Residue Food and Water Input File.

Attachment 2. Clofentezine Chronic Food and Water Results.

Attachment 3. Clofentezine Cancer Food and Water Results. Attachment 4. Clofentezine Chronic and Cancer Food only Input File.

Attachment 5 . Clofentezine Chronic Food Only Results.

Attachment 6 . Clofentezine Cancer Food Only Results.

Attachment 7 . Perc ent Crop Treated Memos from BEAD.Clofentezine Dietary Exposure Assessment DP Number: D429749

PC Code: 125501 Page 11 of 20



### Attachment 1. Clofentezine Chronic and Cancer Residue Input File

US EPA Ver. 3.16, 03

- 08

- d

DEEM

- FCID Chronic analysis for CLOFENTEZINE

Residue file:

C: \ Users \ pbarnes \ Documents \ DEEMRESULTS \ clofentezine \ Clofentezine062015.r08 Adjust. #2 used Analysis Date 06

- 16

- 2015 Residue file dated: 06

- 16

- 2015/18:53:53
Reference dose (RfD) = 0. 013 mg/kg bw/day

Comment: FOOD & DRINKING WATER

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

---------- ---- ------------------------------- ---------- ------ ------ 1400003000 14 Almond 0.090000 1.000 0.050

1400003001 14 Almond

- babyfood 0.090000 1.00 0 0.050
1400004000 14 Almond, oil 0.090000 1.000 0.050
1400004001 14 Almond, oil

- babyfood 0.090000 1.000 0.050 1100007000 11 Apple, fruit with peel 0.120000 1.000 0.0 25 1100008000 11 Apple, peeled fruit 0.120000 1.000 0.025 1100008001 11 Apple, peeled fruit

- babyfood 0.120000 1.000 0.025 1100009000 11 Apple, dried 0.120000 8.000 0.025

1100 009001 11 Apple, dried

- babyfood 0.120000 8.000 0.025 1100010000 11 Apple, juice 0.120000 0.105 0.025 1100010001 11 Apple, juice

- babyfood 0.120000 0.105 0.025

1100011000 11 Apple, sauce 0.120000 1.000 0.025 1100011001 11 Apple, sauce

- babyfood 0.120000 1.000 0.025 1202012000 12B Apricot 0.440000 1.000 0.025 1202012001 12B Apricot

- babyfood 0.440000 1.000 0.025 1202013000 12B Apricot, dried 0.440000 6.000 0.025 1202014000 12B Apricot, juice 0.440000 1.000 0.025

1202014001 12B Apricot, juice

- babyfood 0.440000 1.000 0.025

9500020000 O Avocado 0.087000 1.000 1.000
3100044000 31 Beef, meat 0.000040 1.000 1.000

3100044001 31 Beef , meat

- babyfood 0.000040 1.000 1.000
3100045000 31 Beef, meat, dried 0.000040 1.920 1.000 3100046000 31 Beef, meat byproducts 0.006000 1.000 1.000 3100046001 31 Beef, meat byp roducts

- babyfood 0.006000 1.000 1.000
3100047000 31 Beef, fat 0.000040 1.000 1.000
3100047001 31 Beef, fat

- babyfood 0.000040 1.000 1.000 3100048000 31 Beef, kidney 0.001000 1.000 1.000
3100049000 31 Beef, liver 0.006000 1.000 1.000
3100049001 31 Beef, liver

- babyfood 0.006000 1.000 1.000 1201090000 12A Cherry 0.190000 1.000 0.050 1201090001 12A Cherry

- babyfood 0.190000 1.000 0.050 1201091000 12A Cherry, juice 0.190000 1.500 0.050 1201091001 12A Cherry, juice

- babyfood 0.190000 1.500 0.050
3200169000 32 Goat, meat 0.000040 1.000 1.000
3200171000 32 Goat, fat 0.000040 1.000 1.000 3200172000 32 Goat, kidney 0.001000 1.000 1.000
3200173000 32 Goat, liver 0.006000 1.000 1.000 1304175000 13D Grape 0.140000 1.000 0.010 1304176000 13D Grape, juice 0.140000 0.090 0.010 1304176001 13D Grape, juice

- babyfood 0.140000 0.090 0.010 9500177000 O Grape, leaves 0.140000 1.000 0.010 9500178000 O Grape, raisin 0.140000 0.300 0.010 1304179000 13D Grape, wine and sherry 0.140000 1.000 0.010
3300189000 33 Horse, meat 0.000040 1.000 1.000 3800221000 38 Meat, game 0.000040 1.000 1.000

3600222000 36 Milk, fat 0.000300 1.000 1.000Clofentezine Dietary Exposure Assessment DP Number: D429749

PC Code: 125501 Page 12 of 20

3600222001 36 Milk, fat

- baby food/infant formu 0.000300 1.000 1.000
3600223000 36 Milk, nonfat solids 0.000300 1.000 1.000

3600223001 36 Milk , nonfat solids

- baby food/in 0.000300 1.000 1.000
3600224000 36 Milk, water 0.000300 1.000 1.000
3600224001 36 Milk, water

- babyfood/infant form 0.000300 1.000 1.000
3600225001 36 Milk, sugar (l actose)

- baby food/ 0.000300 1.000 1.000

1202230000 12B Nectarine 0.120000 1.000 0.050 9500245000 O Papaya 0.087000 1.000 1.000 9500245001 O Papaya

- babyfood 0.087000 1.000 1.000 9500246000 O Papaya, dried 0.087000 1.800 1.000 9500247000 O Papaya, juice 0.087000 1.500 1.000

1202260000 12B Peach 0.130000 1.000 0.050

1202260001 12B Peach

- babyfood 0.130000 1.000 0.050
1202261000 12B Peach, dried 0.130000 7.000 0.050
1202261001 12B Peach, dried

- babyfood 0.130000 7.000 0.050 1202262000 12B Peach, juice 0.130000 1.000 0.050 1202262001 12B Peach, juice

- babyfood 0.130000 1.000 0.050

1100266000 11 Pear 0.150000 1.000 0.050

1100266001 11 Pear

- babyfood 0.150000 1.000 0.050
1100267000 11 Pear, dried 0.150000 6.250 0.050 1100268000 11 Pear, juice 0.150000 0.105 0.050 1100268001 11 Pear, juice

- babyfood 0.150000 0.105 0.050

9500277000 O Persimmon 0.024000 1.000 1.000

3400290000 34 Pork, meat 0.000040 1.000 1.000
3400290001 34 Pork, meat

- babyfood 0.000040 1.000 1.000
3400291000 34 Pork, skin 0.000040 1.000 1.000

3400292000 34 Pork , meat byproducts 0.006000 1.000 1.000 3400292001 34 Pork, meat byproducts

- babyfood 0.006000 1.000 1.000
3400293000 34 Pork, fat 0.000040 1.000 1.000
3400293001 34 Pork, fat

- baby food 0.000040 1.000 1.000 3400294000 34 Pork, kidney 0.001000 1.000 1.000
3400295000 34 Pork, liver 0.006000 1.000 1.000 3500339000 35 Sheep, meat 0.000040 1.000 1.000 3500339001 35 Sheep, meat

- babyfood 0.000040 1.000 1.000 3500340000 35 Sheep, meat byproducts 0.000040 1.000 1.000 3500341000 35 Sheep, fat 0.000040 1.000 1.000 3500341001 35 Sheep, fat

- babyfood 0.000040 1.000 1.000 3500342000 35 Sheep, kidney 0.001000 1.000 1.000 3500343000 35 Sheep, liver 0.006000 1.000 1.000

1400391000 14 Walnut 0.020000 1.000 0.050
8601000000 86A Water, direct, all sources 0.000062 1.000 1.000
8602000000 86B Water, indirect, all sources 0.000062 1.000 1.000Clofentezine Dietary Exposure Assessment DP Number: D429749

PC Code: 125501 Page 13 of 20



### Attachment 2. DEEM

- FCID Chronic R esults.

US EPA Ver. 3.16, 03

- 08

- d

DEEM

- FCID Chronic analysis for CLOFENTEZINE NHANES 2003

- 2008 2

- day

Residue file name:

C: \ Users \ pbarnes \ Documents \ DEEMRESULTS \ clofentezine \ Clofentezine062015.r08 Adjustment factor #2 used. Analysis Date 06

- 16

- 2015/18:58:20 Residue file dated: 06

- 16

- 2015/18:53:53
Reference dose (RfD, Ch ronic) = .013 mg/kg bw/day

COMMENT 1: FOOD & DRINKING WATER

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

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

Total Exposure

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

-------------------------------------- ------------- ---------------- Total US Population 0.000010 0.1% Hispanic 0.000016 0.1%

Non

- Hisp

- White 0.000009 0.1%

Non

- Hisp

- Black 0.000008 0.1%

Non

- Hisp

- Other 0.000014 0.1% Nursing Infants 0.000024 0.2%

Non

- Nursing Infants 0.000032 0.2%

Female 13+ PREG 0.000 012 0.1%

Children 1

- 6 0.000029 0.2%

Children 7

- 12 0.000012 0.1%

Male 13

- 19 0.000006 0.0%

Female 13

- 19/NP 0.000006 0.0%

Male 20+ 0.000007 0.1% Female 20+/NP 0.000009 0.1%

Seniors 55+ 0.000008 0.1%

All Infants 0.000029 0.2%

Female 13

- 50 0.000008 0.1%

Children 1

- 2 0.000039 0.3%

Chi ldren 3

- 5 0.000024 0.2%

Children 6

- 12 0.000013 0.1%

Youth 13

- 19 0.000006 0.0%

Adults 20

- 49 0.000008 0.1%

Adults 50

- 99 0.000008 0.1%

Female 13

- 49 0.000008 0.1%

---------------------------------------------------------------------- ---------Clofentezine Dietary Exposure Assessment DP Number: D429749

PC Code: 125501 Page 14 of 20



### Attachment 3. Clofentezine Cancer Results.

US EPA Ver. 3.16, 03

- 08

- d

DEEM

- FCID Chronic analysis for CLOFENTEZINE NHANES 2003

- 2008 2

- day

Residue file name: C: \ Users \ pba rnes \ Documents \ DEEMRESULTS \ clofentezine \ Clofentezine062015.r08 Adjustment factor #2 used. Analysis Date 06

- 16

- 2015/18:57:15 Residue file dated: 06

- 16

- 2015/18:53:53

Q* = 0.0376

COMMENT 1: FOOD & DRINKING WATER

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

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

Total Exposure

----------------------------------- Population mg/kg Lifetime risk Subgroup body wt/day ( Q*= .0376)

-------------------------------------- ------------- -------------- Total US Population 0.000010 3.85E

- 07

-------------------------------------------------------------------------------Clofentezine Dietary Exposure Assessment DP Number: D429749

PC Code: 125501 Page 15 of 20



### Attachment 4 . Clofentezine Chronic and Cancer Food only Input File

US EPA Ver. 3.16, 03

- 08

- d

DEEM

- FCID Chronic analysis for CLOFENTEZINE

Residue file: C: \ Users \ pbarnes \ Documents \ DEEMRESULTS \ clofentezine \ Clofentezine Food Only.R08 Adjust. #2 used Analysis Date 06

- 16

- 2015 Residue file dated: 06

- 16

- 2015/19:45:24

Reference dose (RfD) = 0.013 mg/kg bw/day

Comment:FOOD ONLY

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

---------- ---- ------------------------------- ---------- ------ ------ 1400003000 14 Almond 0.090000 1.000 0.050

1400003001 14 Almond

- babyfood 0.090000 1.000 0. 050
1400004000 14 Almond, oil 0.090000 1.000 0.050
1400004001 14 Almond, oil

- babyfood 0.090000 1.000 0.050 1100007000 11 Apple, fruit with peel 0.120000 1.000 0.025

110 0008000 11 Apple, peeled fruit 0.120000 1.000 0.025 1100008001 11 Apple, peeled fruit

- babyfood 0.120000 1.000 0.025 1100009000 11 Apple, dried 0.120000 8.000 0.025

1100009001 11 Apple, dried

- babyfood 0.120000 8.000 0.025 1100010000 11 Apple, juice 0.120000 0.105 0.025 1100010001 11 Apple, juice

- babyfood 0.120000 0.105 0.025 1100011000 11 Apple, sauce 0.120000 1.000 0.025 1100011001 11 Apple, sauce

- babyfood 0.120000 1.000 0.025 1202012000 12B Apricot 0.440000 1.000 0.025

1202012001 12B Apricot

- babyfood 0.440000 1.000 0.025 1202013000 12B Apricot, dried 0.440000 6.000 0.025 1202014000 12B Apricot, juice 0.440000 1.000 0.025 1202014001 12B Apri cot, juice

- babyfood 0.440000 1.000 0.025

9500020000 O Avocado 0.087000 1.000 1.000
3100044000 31 Beef, meat 0.000040 1.000 1.000
3100044001 31 Beef, meat

- bab yfood 0.000040 1.000 1.000
3100045000 31 Beef, meat, dried 0.000040 1.920 1.000 3100046000 31 Beef, meat byproducts 0.006000 1.000 1.000 3100046001 31 Beef, meat byproducts

- ba byfood 0.006000 1.000 1.000
3100047000 31 Beef, fat 0.000040 1.000 1.000
3100047001 31 Beef, fat

- babyfood 0.000040 1.000 1.000 3100048000 31 Beef, kidney 0.001000 1.000 1.000
3100049000 31 Beef, liver 0.006000 1.000 1.000
3100049001 31 Beef, liver

- babyfood 0.006000 1.000 1.000 1201090000 12A Cherry 0.190000 1.000 0.050 1201090001 12A Cherry

- babyfood 0.190000 1.000 0.050 1201091000 12A Cherry, juice 0.190000 1.500 0.050 1201091001 12A Cherry, juice

- babyfood 0.190000 1.500 0.050
3200169000 32 Goat, meat 0.000040 1.000 1.000
3200171000 32 Goat, fat 0.000040 1.000 1.000 3200172000 32 Goat, kidney 0.001000 1.000 1.000
3200173000 32 Goat, liver 0.006000 1.000 1.000 1304175000 13D Grape 0.140000 1.000 0.010

1304176000 13D Grape, juice 0.140000 0.090 0.010 1304176001 13D Grape, juice

- babyfood 0.140000 0.090 0.010 9500177000 O Grape, leaves 0.140000 1.000 0.010 9500178000 O Grap e, raisin 0.140000 0.300 0.010 1304179000 13D Grape, wine and sherry 0.140000 1.000 0.010
3300189000 33 Horse, meat 0.000040 1.000 1.000 3800221000 38 Meat, game 0.000040 1.000 1.000
3600222000 36 Milk, fat 0.000300 1.000 1.000Clofentezine Dietary Exposure Assessment DP Number: D429749

PC Code: 125501 Page 16 of 20

3600222001 36 Milk, fat

- baby food/infant formu 0.000300 1.000 1.000
3600223000 36 Milk, nonfat solids 0.000300 1.000 1.000
3600223001 36 Milk, nonfat solids

- baby food/in 0.000300 1.000 1.000
3600224000 36 Milk, water 0.000300 1.000 1.000
3600224001 36 Milk, water

- babyfood/infant form 0.000300 1.000 1.000 3600225001 36 Milk, sugar (lactose)

- baby food/ 0.000300 1.000 1.000

1202230000 12B Nectarine 0.120000 1.000 0.050 9500245000 O Papaya 0.087000 1.000 1.000 9500245001 O Papaya

- babyfood 0.087000 1.000 1.000 9500246000 O Papaya, dried 0.087000 1.800 1.000 9500247000 O Papaya, juice 0.087000 1.500 1.000

1202260000 12B Peach 0.130000 1.000 0.050

1202260001 12B Peach

- babyfood 0.130000 1.000 0.050
1202261000 12B Peach, dried 0.130000 7.000 0.050
1202261001 12B Peach, dried

- babyfood 0.130000 7.000 0.050 1202262000 12B Peach, juice 0.130000 1.000 0.050

1202262001 12B Peach, juice

- babyfood 0.130000 1.000 0.050

1100266000 11 Pear 0.150000 1.000 0.050

1100266001 11 Pear

- babyfood 0.150000 1.000 0.050

1100267000 11 Pear , dried 0.150000 6.250 0.050 1100268000 11 Pear, juice 0.150000 0.105 0.050 1100268001 11 Pear, juice

- babyfood 0.150000 0.105 0.050

9500277000 O Persimmon 0.024000 1.000 1.000
3400290000 34 Pork, meat 0.000040 1.000 1.000
3400290001 34 Pork, meat

- babyfood 0.000040 1.000 1.000
3400291000 34 Pork, skin 0.000040 1.000 1.000 3400292000 34 Pork, meat byproducts 0.006000 1.000 1.000 3400292001 34 Pork, meat byproducts

- babyfood 0.006000 1.000 1.000
3400293000 34 Pork, fat 0.000040 1.000 1.000
3400293001 34 Pork, fat

- babyfood 0.000040 1.000 1.000 3400294000 34 Pork, kidney 0.001000 1.000 1.000
3400295000 34 Pork, liver 0.006000 1.000 1.000 3500339000 35 Sheep, meat 0.000040 1.000 1.000 3500339001 35 Sheep, meat

- babyfood 0.000040 1.000 1.000 3500340000 35 Sheep, meat byproducts 0.000040 1.000 1.000 3500341000 35 Sheep, fat 0.000040 1.000 1.000 3500341001 35 Sheep, fat

- babyfood 0.000040 1.000 1.000 3500342000 35 Sheep, kidney 0.001000 1.000 1.000 3500343000 35 Sheep, liver 0.006000 1.000 1.000

1400391000 14 Walnut 0.020000 1.000 0.050Clofentezine Dietary Exposure Assessment DP Number: D429749

PC Code: 125501 Page 17 of 20



### Attachment 5. Clofentezine Chronic Food Only Results

US EPA Ver. 3.16, 03

- 08

- d

DEEM

- FCID Chronic analysis for CLOFENTEZINE NHANES 2003

- 2008 2

- day

Residue file name: C: \ Users \ pbarnes \ Documents \ DEEMRESULTS \ clofentezine \ Clofentezine Food Only.R08 Adjustment factor #2 used. Analysis Date 06

- 16

- 2015/19:46:23 Residue file dated: 06

- 16

- 2015/19:45:24 Reference dose (RfD, Chronic) = .013 mg/kg bw/day

COMMENT 1: FOOD ONLY

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

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

Total Exposu re

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

---------------------- ---------------- ------------- ---------------- Total US Population 0.000009 0.1% Hispanic 0.000015 0.1%

Non

- Hisp

- White 0.000008 0.1%

Non

- Hisp

- Black 0.000007 0.1%

Non

- Hisp

- Other 0.000013 0.1% Nursing Infants 0.000023 0.2%

Non

- Nursing Infants 0.000028 0.2%

Female 13+ PREG 0.000010 0.1%

Children 1

- 6 0.000028 0.2%

Children 7

- 12 0. 000011 0.1%

Male 13

- 19 0.000005 0.0%

Female 13

- 19/NP 0.000005 0.0%

Male 20+ 0.000006 0.0%

Female 20+/NP 0.000007 0.1%

Seniors 55+ 0.000007 0.1%

All Infants 0.000026 0.2%

Female 13

- 50 0.000007 0.1%

Children 1

- 2 0.000037 0.3%

Children 3

- 5 0.000023 0.2%

Children 6

- 12 0.000012 0.1%

Youth 13

- 19 0.000005 0.0%

Adults 20

- 49 0.000007 0.1%

Adults 50

- 99 0.000007 0.1%

Female 13

- 49 0.000007 0.1%

-------------------------------------------------------------------------------Clofentezine Dietary Exposure Assessment DP Number: D429749

PC Code: 125501 Page 18 of 20



### Attachment 6. Clofentezine Cancer Food Only Results

DEEM

- FCID Chronic analysis for CLOFENTEZINE NHANES 2003

- 2008 2

- day

Residue file name: C: \ Users \ pbarnes \ Documents \ DEEMRESULTS \ clofentezine \ Clofentezine Food Only.R08 Adjustment factor #2 used. Analysis Date 06

- 16

- 2015/19:47:17 Residue file dated: 06

- 1 6

- 2015/19:45:24

Q* = 0.0376

COMMENT 1: FOOD ONLY

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

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

Total Exposure

----------------------------------- Population mg/kg Lifetime risk Subgroup body wt/day (Q*= .0376)

-------------------------------------- ------------- -------------- Total US Population 0.000009 3.36E

- 07

---------------------------------------- ---------------------------------------Clofentezine Dietary Exposure Assessment DP Number: D429749

PC Code: 125501 Page 19 of 20



### Attachment 7 . Percent Crop Treated Memos from BEAD

.

Screening Level Usage Analysis (SLUA) Date: December 9, 2014 What is a Screening Level Usage Analysis (SLUA)?

• Available estimates of pesticide usage data for a particular active ingredient that is used on agricultural crops in the United States.

• Pesticide usage data obtained from various sources. The data are then merged, averaged, and rounded so that the presented information is not proprietary, business confidential, or trade secret.

What does it contain?

• Pesticide usage data for a single active ingredient only.

• Agricultural use sites (crops) that the pesticide is reported to be used on.

• Available pesticide usage information from U.S. states that p roduce 80% or more of a crop, in most cases, or less than 80%, in rare cases, depending on the scope of the survey and available resources.

• Annual percent of crop treated (average & maximum) for each agricultural crop.

• Average annual pounds of the pe sticide applied for each agricultural crop (i.e., for the states surveyed, not for the entire United States). What assumptions can I make about the reported data?

• Average pounds of active ingredient applied

- Values are calculated by merging pesticide u sage data sources together; averaging across all observations, then rounding. Note: If the estimated value is less than 500, then that value is labeled <500. Estimated values between 500 & <1,000,000 are rounded to 1 significant digit. Estimated values of 1,000,000 or greater are rounded to 2 significant digits.)

• Average percent of crop treated

- Values are calculated by merging data sources together; averaging by year, averaging across all years, & rounding to the nearest multiple of 5. Note: If the estimated value is less than 2.5, then the value is labeled <2.5. If the estimated value is less than 1,

then the value is labeled <1.

• Maximum percent of crop treated

- Value is the single maximum value reported across all data sources, across al l years, & rounded up to the nearest multiple of 5. Note: If the estimated value is less than 2. 5, then the value is labeled <2. 5.

What are the data sources used?

• USDA

- NASS (United States Department of Agriculture's National Agricultural Statistics Service) pesticide usage data from 2004 to 2012.

• Private pesticide market research

- pesticide usage data from 2004 to 2012.

• California Department of Pesticide Regu lation (DPR) Pesticide Use Reporting (PUR) data for

2004 to 2011.

What are the limitations to the data?

• Additional registered uses may exist but are not included because the available surveys do not report usage (e.g., small acreage crops).

• Lack of reported usage data for the pesticide on a crop does not imply zero usage.

• Usage data on a particular site may be noted in data sources, but not quantified. In these instances,

T he site would not be reported in the SLUA.

• Non

- agricultural use sites (e. g., turf, post

- harvest, mosquito control, etc.) are not reported in the

SLUA. A separate request must be made to receive these estimates.

• Some sites show some use, even though they are not on the label. This usage could be due to various factors, incl uding, but not limited to Section 18 requests, existing stocks of the chemical, data collection errors, and experimental use permits (EUPs ).Clofentezine Dietary Exposure Assessment DP Number: D429749

PC Code: 125501 Page 20 of 20



### Date: December 9, 2014 Screening Level Estimates of Agricultural Uses of Clofentezine (125501)

· Sorted Alphabetically
Reporting Years: 2004

- 2012

Crop

Lbs. A.I. Percent Crop Treated

Average Maximum

1 

### Almonds 4 ,000 5 10

2 

### Apples 1 ,000 <2.5 10

3 

### Apricots <500 <2.5 <2.5

4 

### Cherries 1,000 5 10

5 

### Grapes <500 

### <1 <2.5

6 

### Nectarines <500 5 10

7 

### Peaches 1,000 5 15

8 

### Pears <500 5 10

9 

### Walnuts 2,000 5 

### 10

All numbers are rounded.

<500 : less than 500 pounds of active ingredients

. <2.5: less than 2.5 percent of crop is treated. <1: less than 1 percent of crop is treated.

SLUA data sources include:

• USDA

- NASS (United States Department of Agriculture's National Agricultural Statistics Service)

• Private Pesticide Market Research

• These results reflect amalgamated data developed by the Agency and are releasable to the public.

• These results reflect amalgamated data developed by the Agency and are releasable to the public.