UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

WASHINGTON, D.C. 20460 

MEMORANDUM 

Date: May 20, 2016 

OFFICE OF CHEMICAL SAFETY 

AND POLLUTION PREVENTION 

SUBJECT: Clofentezine. Addendum to February 2016 Human Health Risk Assessment 

(D423333). Cancer Assessments Incorporating Typical Application Rates for 

Existing Grape and Floriculture Uses as well as Tolerance Recommendations for 

Small Fruit Vine Climbing Except Fuzzy Kiwifruit Subgroup 13-07F. 

PC Code: 125501 

Decision No.: 495217 

Petition No.: NA 

DP Barcode: D433504 

Registration No.: NA 

Regulatory Action: Section 3 Registration 

Risk Assessment Type: NA Case No.: NA 

TXRNo.:NA 

MRIDNo.:NA 

CAS No.: 74115-24-5 

40CFR:NA 

FROM: Evisabel Craig, Ph.D., DABT, Risk assessor .e/ , ~flAUA/ Bridgett Bobowiec, Biologist ~ ~ ~ L Q 

Risk 

Health 

Assessment 

Effects Division 

Branch 

(7509P) 

VI ~ 

THROUGH: Donna Davis, Branch Chief 

Risk Assessment Branch VI 

Health Effects Division (7509P) 

TO: Andy Ertman, Chemical Review Manager 

Barbara Madden, Team Leader 

Marion Johnson, Branch Chief 

Minor Use and Emergency Response Branch 

Registration Division (7505P) 

And 

Wilhelmena Livingston, Risk Manager Reviewer 

Tom Myers, Team Leader 

Kevin Costello, Branch Chief 

Risk Management and Implementation Branch IV 

Pesticide Re-evaluation Division (7508P) 

Page 1 of9 
A Section 3 registration was requested by the Interregional Research Project No. 4 (IR-4), in 

cooperation with the registrant, Makhteshim Agan ofNorth America, INC. for use of technical 

clofentezine (EPA Reg. No.74054-1) and the suspension concentrate (SC) formulation 

APOLLO® SC Ovicide/Miticide (EPA Reg. No. 66222-4 7) containing 42% active ingredient on 

avocado, and papaya, as well as inclusion of the crop subgroups; stone fruit (12-12A), and (12-

12B), pome fruits ( 11-1 0), and small fruit vines except fuzzy subgroup ( 13-07F). 

The most recent 2016 clofentezine risk assessment (E. Craig et al., D423333, 02110/2016) was 

based on current Agency policy, and updated the dermal absorption factor from 1% to 10%. 

Occupational exposure associated with handler activities (i.e., mixing, loading, and applying) as 

well as with post-application activities (i.e., re-entering treated areas) was included in the 

clofentezine noncancer as well as the clofentezine cancer assessment. Short-term (ST) 1 to 30 

days and intermediate term (IT) 1 to 6 months durations were assessed. Long-term exposures 

greater than 6 months are not anticipated. 

There were no occupational exposure risks of concern identified for the proposed avocado and 

papaya included in the Section 3 action. However, there were dermal post application risks of 

concern (MOE < 1 00) identified for the previously registered grape and floriculture clofentezine 

uses. The registrant agreed to mitigation methods including label changes prohibiting grape 

girdling and turning activities as well as increasing the reentry timing for high transfer 

coefficient post application activities such as hand harvesting. These label changes are 

incorporated into HED's addendum assessment (E. Craig et al., D431534, 02/1 0/2016). In 

addition, the registrant submitted a request to voluntarily cancel EPA Registration No. 66222-65. 

This memorandum further refines the latest risk assessment by incorporating the typical 

application rates provided by the biological and economic analysis division (BEAD) (C. 

Doucoure, Clofentezine Usage Data to Support HED's Lifetime Average Daily Dose 

Calculations, 09/20/2011) and (C. Doucoure, Clofentezine (125501) Typical Application Rate 

for Grapes to Support HED's Occupational Risk Assessment DP#433503 05116/2016) into the 

clofentezine cancer assessment for both private and commercial occupational handlers as well as 

post-application workers. Occupational handler exposure and risk estimates presented in the 

tables include various levels of personal protection equipment (PPE). These levels include 

baseline dermal single layer (SL) which is comprised of a long sleeved shirt, pants, shoes plus 

socks, dermal single layer with gloves (SL/G), and double dermal layer (coveralls over SL) with 

gloves (DLIG), and no respirator (No-R). HED recommends all clofentezine labels require 

baseline dermal (long sleeved shirt, long pants, shoes plus socks) as well chemical resistant 

gloves (i.e., such as barrier laminate, butyl rubber, neoprene rubber, poly-vinyl chloride (PVC), 

or Viton®. A respirator requirement does not seem warranted with the current use pattern and 

risk estimates calculated. 

These three addendum tables replace occupational tables found in the last RA and latest 

addendum to the risk assessment (E. Craig et al. , D431534, 02/10/20 16) as well as the exposure 

and risk estimate tables (Tables 6.1.4. 6.1.5, and 9.2.2.2) found in the last exposure assessment 

(B. Bobowiec, D429731 , 10/16/20 15). Below the addendum tables are followed by the original 

tables for comparative purpose. 

Page 2 of9 
Addendum Table 1: Short/Intermediate Term Occupational Commercial Handler 

Cancer Exposure and Risk Estimates Clofentezine with 

at Typica l Application Rates1 

Contract/Commercial Handler Lifetime Contract/Commercial Handler Contra

Exposure Scenario Crop I Target Average Dermal Dose and Inhalation Dose Lifetime Average Combined Cancer 

Category (mg/kg/day) Dose (mg/kg-dayf 

Formulation Application SL/No G SLIG DLIG No-R SL/No G SLIG + DLIG + SL/No G 

Equipment + No-R No-R No-R + No-R 

Mixer/Loader 

Nursery and 4.61 E-05 7.89E-06 6.12E-06 4.61 E-07 4.65E-05 8.37E-06 6.60E-06 1.75E-0

Ground 

Greenhouse 

boom Orchard/Vineyard 8.11 E-05 1.39E-05 1.07E-05 8.08E-07 8.19E-05 1.47E-05 1.15E-05 3.08E-0

LIS

C/EC Field crop, 1.62E-04 2.78E-05 2. 15E-05 1.62E-06 1.64E-04 2.94E-05 2.31 

E-05 6.17E-0

typical 

Nursery and 1.54E-05 2.64E-06 2.04E-06 1.53E-07 1.56E-05 2.79E-06 2. 19E-06 5.87E-0

Air blast Greenhouse 

Orchard/Vineyard 8.11 E-05 1.39E-05 1.07E-05 8.08£-07 8.19E-05 1.47

E-05 1.15E-05 3.08E-0

Ap(Jiicator 

Nursery and 1.65E-05 3.39E-06 2.65E-06 7.15E-07 1.72E-05 4.09E-06 3.37E-06 6.47E-0

Ground Greenhouse 

boom Orchard/Vineyard 2.90E-05 5.94E-06 4.65E-06 1.25E-06 3.02E-05 7. 19E-06 5.90E-06 1.14E-0

Spray Field crop, 5.83E-05 1.1 9E-05 9.33

E-06 2.51 E-06 6.09E-05 1.44E-05 1.18E-05 2.29E-0

typical 

Nursery and 1.24E-04 1.12E-04 1.04E-04 3.30E-06 1.27E-04 1.15

E-04 1.07E-04 4.78E-0

Air blast Greenhouse 

Orchard/Vineyard 6.56E-04 5.86

E-04 5.46

E-04 1.74E-05 6.75E-04 6.05

E-04 5.64E-04 2.54E-0

Mixer/Loader/Applicator 

Nursery and 

Backpack Greenhouse and 3.69E-05 3. 14

E-05 1.75E-05 3.91 E-06 4.09E-05 3.53E-05 2.1 4E-05 1.54E-0

Christmas Tree 

farm 

Manually- Greenhouse and 

LISC/EC pressurized Nursery 2.80E-04 1.20

E-06 1.03E-06 8.41 E-07 2.81 E-04 2.04E-06 1.87E-06 1.06E-0

Hand wand 

Mechanic- Orchard/Vineyard 

ally- Nursery, and 2.40E-04 7.19E-05 5.35E-05 7. 19£-06 2.47E-04 7.93E-05 6.09E-05 9.29E-0

pressurized Christmas Tree 

Handgun Greenhouse 2.45E-04 1.75E-04 1.12E-04 8.41 E-05 3.29E-04 2.59E-04 1.96E-04 1.24E-0

--·- - -

I Commercial growers are assessed assuming 30 days of exposure per year. 

2 Total LADD = Total Absorbed Dose [Dermal Do~ + Inhalation Dose]* Days per year of exposure X years per lifetime of exposure I (365 days/year x Lifetime e

3 Cancer risk estimates = LADD * Q,·, where Q,· = 3.76 X 10 ·' (mglkg/day)''. 

4 Crops are assessed at the typical rates (Floriculture 0.076 lb ai/NO.OOI52 lb ai/gallon, Orchard crops and grapes assessed at 0.2 lb ai/N0.004 lb ai/gallon. Formula

concentrates, soluble concentrates, or emulsifiable concentrates (LISC/EC). 

5 Based on the "Occupational Pesticide Handler Unit Exposure Surrogate Reference Table" (September, 2015). Level of mitigation: SL!No G (Single layer dermal p

long pants, and socks and shoes) no gloves; SLIG (single layer dem1al protectim) plus the addition of gloves, DL!G (Double layer dermal protection plus the addi

Page 3 of9 
Addendum Table 2: Occupational Private/Farmer Handler Cancer Exposure and Risk Estimates for Proposed Use of Clofentezine Registere

Dermal Absorption and Typical Rates 1 

Private/Farmer Handler Lifetime Average Private/Farmer Private

Exposure Scenario Crop I Target Dermal Dose and Inhalation Dose Lifetime Average Combined Dose 

(mg/kg/day) mg/kg-day 2 

Application Category SL/No G SLIG+ DLIG + SL/No G 

Formulation Equipment SL/No G SLIG 

DLIG No-R +No-R No-R No-R +No-R 

Mixer/Loader 

Nursery and I .54E-05 2.63E-06 2.04E-06 1.54E-07 1.55E-05 2.79E-06 2.20E-06 5.83E-0

Ground Greenhouse 

boom Orchard/Vineyard 2.70E-05 4.62E-06 3.58E-06 2.69E-07 2.73E-05 4.89E-06 3.85E-06 1.03E-0

LISC/EC Field crop, typ ical 5.4 1 E-05 9.26E-06 7. 17E-06 5.38E-07 5.46E-05 9.80E-06 7.71 

E-06 2.05E-0

Nursery ( 5. 14

E-06 8.79E-07 6.80E-07 5. I I E-08 5. 19E-06 9.3 IE-07 7.3 1 E-07 1.95E-0

Air blast 

Orchard/Vineyard 2.70E-05 4.62E-06 3.58E-06 2.69E-07 2.73E-05 4.89E-06 3.85E-06 1.03E-0

Applicator 

Nursery and 5.5 I E-06 1.13

E-06 8.84E-07 2.38E-07 5.74E-06 1.36E-06 I. I 2E-06 2. 16E-0

Ground Greenhouse 

boom Orchard/Vineyard 9.66E-06 1.98E-06 I .55E-06 4. 18E-07 1.0 I E-05 2.40E-06 1.97E-06 3.80E-0

Field crop, typical 1.94E-05 3.97E-06 3.1 I E-06 8.36E-07 2.03E-05 4.81 E-06 3.95E-06 7.63E-0

Spray Nursery 

(ornamentals, 4.13E-05 3.72E-05 3.45E-05 1.1 OE-06 4.24E-05 3.84E-05 3.57E-05 1.59E-0

Air blast vegetables, trees, 

container stock) 

Orchard/Vineyard 2. 19E-04 I .95E-04 1.82E-04 5.79E-06 2.25E-04 2.02E-04 I .88E-04 8.46E-0

Mixer/Loader/Applicator 

Nursery and 

Backpack Greenhouse and I .23E-05 1.05E-05 5.83E-06 I .30E-06 1.36E-05 I. I 8E-05 7. 13 E-06 5. 11 E-0

Christmas Tree 

Manually- Nursery and pressurized 9.34E-05 4.01E-07 3.42E-07 2.80E-07 9.37E-05 6.81E-07 6.22E-07 3.52E-0

LISC/EC 

Hand wand Greenhouse 

Mechanic- Orchard/Vineyard 

ally- and Nursery and 7.99E-05 2.40E-05 1.78E-05 2.40E-06 8.24E-05 2.64E-05 2.03E-05 3.10E-0

pressurized 

Christmas Tree 

Handgun Greenhouse 8. 18E-05 5.84E-05 3.74E-05 2.80E-05 I. IOE-04 8.64E-05 6.54E-05 4. 14E-0

--

Private growers are assessed assuming I 0 days of exposure per year. The term "private grCMier" means that the grower or one of the workers would apply the pestic

grower. 

2 Total LADD = Total Absorbed Dose [Dermal Dos;: + Inhalation Dose]* Days per year of exposure X years per lifetime of exposure I (365 days/year x Lifetime exp

3 Cancer risk estimates = LADD * Q1' , where 

Q1' = 3.76 X I 0 ·2 (mglkg/day)" 1. 

4 Crops are assessed at the typical rates (Floriculture 0.076 lb ai/A/0.00 152 lb ail gallon, Orchard crops and grapes assessed at 0.2 lb ai/A/0.004 lb ai/gallon. Formul ate

concentrates, soluble concentrates, or emulsifiable concentrates (LISC/EC). 

5 Based on the "Occupational Pesticide Handler 

Unit Exposure Surrogate Reference Table" (September, 2015); Level of mitigation: SL/No G (Single layer dermal pr

long pants, and socks and shoes) no gloves; SL/G (single layer dermal protectim) plus the addition of gloves, DLIG (Double layer dem1al protection plus the additio

Page 4 of9 
Original Table: STand IT Term Occupational Commercial Handler Cancer Exposure and Risk Estimates Clofentezine with 10 % Dermal Absorp

Rate1•6 

Contract/Commercial Handler Lifetime Average Contract/Commercial Handler 

Exposure Scenario Lifetime Average Combined Dose Crop I Target Dermal Dose and Inhalation Dose (mg/kg/day)5 (mg/kg-day;2 C

Category4 

Formulation Application SL/No G SLIG DLIG No-R SL/No G SLIG + DLIG + S

Equipment + No-R No-R No-R +

Mixer/Loader 

Nursery and 0.00015 0.00003 2.0 1E-05 1.52E-06 0.00015 2.75E-05 2. 16E-05 

Ground Greenhouse 

boom Orchard!V ineyard 0.00010 1.73E-05 1.34E-05 1.0 1 E-06 0.00010 1.83 E-05 1.44E-05 

LISC/EC Field crop, typical 0.00020 3.47E-05 2.68E-05 2.02E-06 0.00021 3.67E-05 2.89E-05 

Nursery and 5.09E-05 8.67E-06 6.75E-06 5.09E-07 5.13E-05 9.18E-06 7.27E-06 

Air blast Greenhouse 

Orchard/Vineyard 1.01 E-04 1.73E-05 1.34E-05 1.0 I E-06 1.03E-04 1.83E-05 1.44E-05 

App licator 

Nursery and 5.46E-05 1.12E-05 8.7E-06 2.35E-06 5.68E-05 1.35E-05 I. II E-05 

Ground Greenhouse 

boom Orchard/Vineyard 3.63E-05 7.4 1E-06 5.83E-06 1.57E-06 0.00004 0.00001 7.41E-06 

Spray Field crop, typical 7.23E-05 1.49E-05 1. 16E-05 3. 13E-06 7.56E-05 0.00002 1.48E-05 

Nursery and 4.09E-04 3.67E-04 3.41 E-04 1.09E-05 4.20E-04 3.76E-04 3.52E-04 

Air blast Greenhouse 

Orchard/Vineyard 8. 15E-04 7.34E-04 6.82E-04 2. 17E-05 8.37E-04 7.56E-04 7.04E-04 

Mixer/Loader/Applicator 

Nursery and 

Backpack Greenhouse and 1.22E-04 1.03E-04 5.75E-05 1.29E-05 1.35E-04 1.16E-04 7.04E-05 

Christmas Tree farm 

Manually- Greenhouse and pressurized Nursery 0.00092 3.98E-06 3.37E-06 2.77E-06 0.00093 6.75E-06 6. 12E-06 

L/SC/EC Hand wand 

Mechanical Orchard/Vineyard 

ly- Nursery, and 0.0003 0.00009 6.68E-05 0.00001 0.0003 1 9.88E-05 7.56E-05 

Christmas Tree farm, pressurized Field crop, typical Handgun Greenhouse 8.08E-04 5.75E-04 3.69E-04 2.77E-04 1.08E-03 8.52E-04 6.45E-04 

I Commercial growers are assessed assuming 30 days of exposure per year. 

2 Total LADD = Total Absorbed Dose [Dermal Dos: + Inhalation Dose]* Days per year of exposure X years per lifetime of exposure I (365 days/year x Lifetime e

3 Cancer risk estimates = LADD • Q1' , where Q1' = 3.76 X 10 ·2 (mglkg/day)"' . 

4 Crops are assessed at the maximum rate of0.25 lb ai/A or 0.005lbs ai/gallon . Typical rates were not provided for proposed use. 

5 Based on the "Occupational Pesticide Handler Unit Exposure Surrogate Reference Table" (September, 201 5) 

6 Original Table entitled, "Table 6.1.4 Short/Intem1ediate Term Occur.ational Commercial Handler Cancer Exposure and Risk Estimate Clofentezine with I 0% Der

Page 5 of9 
Original Table: Occupational Private/Farmer Handler Cancer Exposure and Risk Estimates for Proposed Use ofCiofentezine Registered Uses with 

Maximum Application Rate1•6 

Lifetime Average Private/Farmer 

Exposure Scenario Private/Farmer Handler Lifetime Average Lifetime Average Combined Dose 

Crop I Target Category Dermal Dose and Inhalation Dose (mg/kg/day) (mg/kg-day)2 

Formulation Application SL/No G SLIG DLIG No-R SL/No G SLIG + DLIG + 

Equipment + No-R No-R No-R 

Mixer/Loader 

Nursery and Greenhouse 5.08E-05 8.67E-06 6.7 1 E-06 5.05E-07 5.13E-05 9. 17E-06 7.22E-06 

Ground 

Orchard/Vineyard 3.38E-05 5.78E-06 4.47E-06 3.37£-07 3.42£-05 6.11 E-06 4.81 E-06 

boom 

Field crop, typical 6.76E-05 1.16E-05 8.95E-06 6.74E-07 6.82£-05 1.22E-05 9.63E-06 

LISC/EC Nursery (ornamentals, 

vegetables, trees, container 1.70E-05 2.89E-06 2.25E-06 1.70£-07 1.71 E-05 3.06E-06 2.42E-06 

Air blast stock) 

Orchard/Vineyard 3.38E-05 5.78E-06 4.47E-06 3.37E-07 3.42E-05 6.IIE-06 4.8 1 E-06 

Applicator 

Ground Nursery and Greenhouse 1.82E-05 3.72E-06 2.9E-06 7.84£-07 1.89E-05 4.51 E-06 3.69E-06 

boom Orchard/Vineyard 1.21 E-05 2.47E-06 1.94E-06 5.22£-07 1.27E-05 0.000003 2.47E-06 

Spray Field crop, typical 2.41 E-05 4.95E-06 3.87E-06 1.04£-06 2.52E-05 0.000006 4.92E-06 

Nursery (ornamentals, 

vegetables, trees, container 1.36£-04 1.22E-04 1.14E-04 3.63£-06 1.40E-04 1.25E-04 1.17E-04 

Air blast stock) 

Orchard/Vineyard 2.72E-04 2.45E-04 2.27£-04 7.24£-06 2.79E-04 2.52£-04 2.35E-04 

Mixer/Loader/Applicator 

Backpack Nursery and Greenhouse and 4.06£-05 3.44£-05 1.92£-05 4.30E-06 4.49E-05 3.87E-05 2.35E-05 

Christmas Tree farm 

Manuallypressurized Nursery and Greenhouse 3.07E-04 1.33E-06 1.12E-06 9.22E-07 3.09E-04 2.25E-06 2.04E-06 

LISC/EC Hand wand 

Mechanical Orchard/Vineyard and Nursery 

ly- and Christmas Tree Farm and 9.99E-05 3.00E-05 2.23£-05 3.00E-06 1.03E-04 3.29E-05 2.52E-05 

pressurized Field crop, typical 

Handgun Greenhouse 2.69E-04 1.92E-04 1.23E-04 9.22E-05 3.61E-04 2.84£-04 2.15E-04 

Private growers are assessed assuming 10 days of exposure per year. The term "private gr(Mier" means that the grower or one of the workers would apply the pestic

grower. 

2 Total LADD = Total Absorbed Dose [Dermal Dos:: + Inhal ation Dose]* Days per year of exposure X years per lifetime of exposure I (365 days/year x Lifetime exp

3 Cancer risk estimates = LADD * Q1' , where Q1' = 3.76 X 10 ·' (mglkg/day)" 1• 

4 Crops are assessed at the maximum rate of 0.25 lb ai/A or 0.005 lbs ail gallon. Typical rates not provided. Formulated clofentezine products are liquid concentrates, s

concentrates (LISC/EC). 

5 Based on the "Occupational Pesticide Handler Un it Exposure Surrogate Reference Table" (September, 2015); Level of mitigation: SL/No G (Single layer dermal pro

long pants, and socks and shoes) no gloves; SLIG (single layer dermal protection) plus the addition of gloves, DLIG (Double layer dermal protection plus the additio

6 Original entitl ed. "Table 6. 1.5 Occupational Private/Farmer Handler Cancer Exposure and Risk Estimate for Proposed Use of Clofentezine Registered Uses with 10% 

I 0/ 16/20 15 

Page 6 of9 
Addendum Table 3: Occupational Post-Application Cancer Risk Estimates Using the Highest Transfer Coefficients for Clofentezine Using 

Policy Crop Typical Transfer Dermal LADD (mgfkgJdav)i 

Crop/Site Group Category Application 

Rate Activities Coefficient DFR1 0 OAT' 0 OAT' 

lb ail A (cm2/hr.)4 

Avocado 99 0.25 1,400 2.58E-04 1.84E-04 9

Papaya Hand-Harvesting 

Floriculture NA 0.076 4,800 2.69E-04 1.92E-04 

Peaches (12-12) 0.17 4.51 E-04 3.22E-04 1

Stone Fruit Thinning Fruit 3,600 

Apples Pome Fruits ( Il-l 0) 0.15 0.5 3.98E-04 2.84E-04 1

Grape, Wine Tying/Training, llg/cm2 

Hand-Harvesting, 10, 100 1.49E-03 1.06E-03 5

And Grape, Juice Hand-Leaf Pulling ( 13-07F) 0.2 Tying/Training, Grape, Table 

Hand-Harvesting, 5,500 8.11 E-04 5.79E-04 3

And Grape 

Raisin Hand-Leaf Pulling 

Dem1al LADD (mg/kg/day) = Dermal dose (mg/kg/day) x [Days per year of exposure (days/yr) + 365 days/year] x [Years per lifetime of exposure (yrs.) + 

2 Daily Dose (mg/kg/day)= DFR (llg/cm2) x 0.00 I mg/ug x Tc (cm2/hr.) x DA (I 0%) x ET (8 hr./day)/80 kg 

3 Cancer risk estimate = Dermal LADD (0 DA Tor 30 day average doses mg/kg/d!y) x Q1', where 

Q1' = 3.76 X I o-' (mg/kg/day) 

4 Transfer coefficients shown in table are not inclusive for all post application activities assumed for crops but represent the highest exposure. 

Original Table: Occupational Post-Application Cancer Exposure a nd Risk Estimates for Proposed C lofentezine Using Maximum Single R

Policy Crop Maximum Transfer Dermal LADD (mg/kg/day) 1 

Crop/Site Group Single Use Activities Coefficient DFR1 0 OAT' 30 Day 

Category Application Rate (cm2/hr.)5 Average 

Avocado 99 1,400 2.58E-04 1.84E-04 

Papaya Hand-Harvesting 

Floriculture NA 4,800 8.85E-04 6.31E-04 

Stone Fruit (12- 12) Thinning Fruit 3,600 6.64E-04 4.73E-04 

Pome Fruits ( Il-l 0) 

Grape, Wine 0.25 lb ail A Tying/Training, Hand- 0.5 

And Grape, Juice Harvesting, Hand-Leaf 10, 100 llg/cm2 1.86E-03 1.33E-03 

Pulling 

( 13-07F) Girdling/ Turning" 19,300 3.56E-03 2.54E-03 

Grape, Table Tying/Training, HandAnd Grape Raisin Harvesting, Hand-Leaf 5,500 I.OI

E-03 7.23E-04 

Pulling 

I Dermal LADD (mglkg/day) = Dermal dose (mg/kg/day) x [Days per year of exposure (days/yr) + 365 days/year] x [Years per lifetime of exposure (yrs.) + 

2 Daily Dose (mglkg/day)= DFR (llg/cm2) x 0.00 I mg/ug x Tc (cm2/hr.) x DA (I 0%) x ET (8 hr./day)/80 kg 

3 Cancer risk estimate = Dermal LADD (0 DAT or 30 day average doses mg/kg/d!y) x Q1', where 

Q1' = 3. 76 X I o-2 (mg/kg/dayt1 

4 These activities are now prohibited for table and raisin grape after application. 

5 Transfer coefficients shown in table are not inclusive for all post application activities assumed for crops but represent the highest exposure. 

6 Original table entitled, "Table 9.2.2.2. Occupational Post-Application Cancer Exposure and Risk Estimates for Proposed 

Clofentezine Uses Using fle Highe

D423333, 02/1 0/20 16. 

Page 7 of9 
Tolerance Recommendation 

Recently, the Registrant petitioned to expand the tolerance for residues of clofentezine in grape 

at 1.0 ppm to the crop group fruit, small, vine climbing, except fuzzy kiwifruit, Subgroup 13-07F 

at 1.0 ppm. At the time the most recent risk assessment was completed (E. Craig et al., 

D423333, 02110/20 16), HED could not recommend in favor of establishing a tolerance for this 

crop subgroup based on worker risks. Subsequently, the Registrant has revised the label. The 

use rate and PHI remain the same; therefore, additional residue chemistry data are not required to 

support this use. Since there are no longer worker risks, HED can now recommend for a 

tolerance for residues of clofentezine in fruit, small, vine climbing, except fuzzy kiwifruit, 

Subgroup 13-07F at 1.0 ppm. HED notes that that the tolerance expressions established under 40 

CFR § 180.446 comply with the HED Interim Guidance on Tolerance Expressions (S. Knizner, 

05/27/2009). Additionally, the currently established tolerance for residues in grape should be 

removed from 40 CFR §180.446 since grapes are a member ofthe fruit, small, vine climbing, 

except fuzzy kiwifruit, Subgroup 13-07F. A summary of the residue chemistry considerations 

can be found in Memo, Y. Barnes, D429732 (10-February-2016). 

Addendum Table 4. Tolerance Summary for Clofentezine 

Proposed Recommended 

Commodity Tolerance Tolerance Correct Commodity Defmition/Comments 

(ppm) (ppm) 

To be established under 40 CFR §180.446 (a) General. (1) 

Fruit, small, vine climbing, 1.0 1.0 Established tolerance for grape (1 ppm) should 

except fuzzy kiwifruit, be removed from the 40CFR and replaced by 

Subgroup 13-07F this subgroup tolerance. 

International Harmonization 

The recommended US tolerance of 1.0 ppm for the crop subgroup fruit, small, vine climbing, 

except fuzzy kiwifruit, 13-07F does not harmonize with the Codex MRL of2.0 ppm. There is no 

Canadian MRL for these commodities. The petitioner proposes to establish the 13-07F subgroup 

tolerance at 1.0 ppm, which would leave the tolerance on grapes at 1.0 ppm, the current US 

grape tolerance level, because several countries including Japan and Korea also maintain an 

MRL at 1.0 ppm. Therefore, HED is recommending that the tolerance of 1.0 ppm be established 

and notes that there are issues of international harmonization created by this approach. 

Dietary Exposure and Risk 

An updated dietary risk assessment is not required since the previously conducted dietary 

assessment included fruit, small, vine climbing, except fuzzy kiwifruit, Subgroup 13-07F at 1.0 

ppm (Memo, Y. Barnes, D429749; 10-November-2015). An acute dietary exposure assessment 

was not performed as no appropriate endpoints were identified from the available clofentezine 

toxicity studies indicating that clofentezine does not pose an acute dietary hazard. Partially 

refined chronic dietary as well as cancer dietary exposure and risk assessments were performed 

that directly incorporated average field trial residues, percent crop treated information, and 

modelled drinking water estimated residues. The estimated exposure to the highest population 

subgroup (children 1 < 2 years old) resulted in an estimated risk of <1% of the chronic 

population adjusted dose (cPAD). The estimated exposure to the general U.S. population 

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resulted in an estimated risk of <1% of the chronic population adjusted dose ( cP AD). Applying 

the Q, * of 3.76 x 1 o-2 mg/kg/day to the exposure value resulted in a cancer risk estimate of 3.8 x 

1 o-7 to the general U.S. population. 

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