UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

MEMORANDUM 

DA TE: 1O-November-2015 

WASHINGTON, D.C. 20460 

OHICE OF Cll O llC.\L S,\FE"I \ 

.\:\D rou.rT10'\' r1u:n :Yr10" 

SUBJECT: Clofentczine. Chronic and Cancer Dietary (Food and Drinking Water) Exposure 

Assessments in Support of Establishment of Permanent Tolerances and Section 3 

Registration for New Use on Avocado and Papaya and Crop Group/Subgroup 

Expansions for Pome Frnit, Group 11-1 O; Cherry Subgroup 12-12A; Peach 

Subgroup l 2-12B and Fruit, small, vine climbing, except fuzzy kiwi, Subgroup 

13-07F. 

PC Code: 125501 DP Barcode: D429749 

Decision No.: 495217 Registration No.: 7602-1 

Petition No.: NA Regulatory Action: Section 3 Registration 

Risk Assessment Type: Dietary Assessment Case No.: NA 

TXR No.: NA CAS No.: 95266-40-3 

MRID No.: NA 40 CFR: 180.446 

REVIEWER: P. Yvonne Barnes, Chemist Jf1~--;e:::>~ Risk Assessment Branch (RABVI) 

Health Effects Division (HED, 7509P) 

THROUGH: Jdeliz Encarnacion, Chemi ~ C...----

Donald Wilbur, Chemist /lJ/ 

Dietary Exposure Science Advisory Council (DESAC) 

Health Effects Division (HED, 7509P) 

and 

Donna s. Davis, Acting Chief n OA(\'\ . Risk 

Healt

As

h Effects 

sessment 

Division 

Branch 

(HE

(RAB 

D. 7509P) 

VI) ~ ~ 

TO: Evisabel Craig, Toxicologist and Risk Assessor 

Risk Assessment Branch VI 

Health Effects Division (HED 7509P) 

and 

Andrew Ertman/Barbara Madden, RM 05 

Risk Integration, Minor Use, Emergency Response Branch 

Registration Division (RD; 7505P) 
Clofentezine Dietary Exposure Assessment DP Number: D429749

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Executive Summary

Chronic and cancer aggregate dietary food and drinking water exposure and risk assessments 

were conducted using the Dietary Exposure Evaluation Model 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 assessment for the proposed Section 3 uses of 

Clofentezine on avocado and papaya and crop group/subgroup expansions for pome fruit, group 

11-10; cherry subgroup 12-12A, peach subgroup 12-12B, and fruit, small, vine climbing, except 

fuzzy kiwi, subgroup 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 concentrations (EDWCs) of 

clofentezine were provided by the Environmental Fate and Effects Division (EFED) and 

incorporated directly into the chronic and cancer assessments. The drinking water assessment 

was based on the previously registered use of clofentezine on 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 populations subgroups. Chronic risk from the dietary (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 Q1* of 0.0376 

(mg/kg/day)-1to the exposure value results 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 Ovicide/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 (PoD, NOAEL, LOAEL, e.g.) divided by the required uncertainty or safety 

factors.
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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.regulations.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 conducted by S. Piper (06/06/2013, 

D404436).

II. Residue Information

Clofentezine is an 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 (0.50 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 

equivalents) 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. Tolerances are established for clofentezine for the group/ subgroups 

expansions based on an existing tolerance for individual representative commodities: pome fruit 

group 11-10 (0.50 ppm); cherry subgroup 12-12A (1.0 ppm); peach subgroup 12-12B (1.0 ppm);

and fruit, small, vine climbing, except fuzzy kiwi subgroup 13-07F (1.0 ppm). No new crop 

field trial data were submitted nor 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 locations was

adequate (ChemSAC 07/30/2014). A new tolerance is proposed and recommended for avocado 

(0.30 ppm) and translated to papaya (0.30 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 metabolite. (Memo, M. Bradley, 08/03/1989; DEB Nos. 5367 

and 5371). There are new ruminant feed items associated with the petition.
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Table 1. Tolerance 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 cattle, goat, horses, pork and sheep 

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 registered commodities when available. 

Default DEEM Version 7.81 processing factors were used for all other registered processed 

commodities (Table 2).
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Table 2

Data and Residue Estimates Used in DEEM-FCID Chronic and Cancer Dietary Analyses

Commodity Food Forms %CT1 Processing Factors

Anticipated 

Residue (AR) 

Estimates2 

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

meat 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.
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III. Percent Crop Treated Information

J. Alsadek, D424398, 12/12/2014

The 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, Persimmons, 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 (D423336, R. Louie-Juzwiak, May 27, 2015) a new 

drinking water assessment is not needed. The 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. The surface water 

EDWCs 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 

average). 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 0.041 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/oppefed1/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

0.26

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 scenario
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V. DEEM Program and Consumption Information

Clofentezine chronic and cancer dietary exposure assessments were conducted using the DEEMFCID, 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 

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. However, for 

acute exposure assessment, consumption data are retained 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 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 50-99

years old.

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

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

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

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

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

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

VI. Toxicological Information

The HED Hazard Identification Assessment Review Committee (HIARC) met on January 07,

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 and 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 adenoma 

and/or carcinoma combined tumor rates. Table 4 is a summary of the decisions made by the 

HIARC concerning dietary exposure assessment.
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Table 4. Summary of Clofentezine Toxicological Doses and Endpoints for Use in Human Risk Assessment1

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

UFA=10x

UFH=10x

FQPA SF=1x

Chronic RfD= 0.013

cPAD= 0.013

1-year chronic dog studyLOAEL = 25 mg/kg, based on 

increased liver weights, 

hepatocellular 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 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. 

VII. Results/Discussion

As stated above, for chronic assessments, HED is concerned when dietary risk exceeds 100% of 

the PAD. The DEEM-FCIDTM analyses estimate the dietary exposure of the U.S. population and 

various population subgroups. The results reported in Table 5 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 50-99 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 summary 

Table 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 0.000010 3.8 x 10-7

All Infants (< 1 year old) 0.000029 <1
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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

VIII. 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 average 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 resulted in higher dietary burden. The 

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 used 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.
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IX. Conclusions

Refined (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) which uses food 

consumption data from the NHANES/WWEIA. The 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 Q1* of 0.0376 (mg/kg/day)-1to the 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. Percent Crop Treated Memos from BEAD.
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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 1.000 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 

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 

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 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 byproducts-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 1.000 
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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 0.050 

8601000000 86A Water, direct, all sources 0.000062 1.000 1.000 

8602000000 86B Water, indirect, all sources 0.000062 1.000 1.000 
Clofentezine Dietary Exposure Assessment DP Number: D429749

PC Code: 125501 Page 13 of 20

Attachment 2. DEEM-FCID Chronic 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\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, Chronic) = .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 0.000012 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%

Children 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\pbarnes\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 

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 

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 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 byproducts-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 1.000 
Clofentezine 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 0.050 
Clofentezine 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 Exposure

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

 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: 06-16-2015/19:45:24

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 produce 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 pesticide 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 usage

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 all 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 Regulation (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,

The 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, including, 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.