UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

WASHINGTON, D.C. 20460 

MEMORANDUM 

Date: February I 0, 201 6 

OFFICE OF CHEMICAL SAFETY 

AND POLLUTION PREVENTION 

SUBJECT: Clofentezine. Label revisions to existing grape and tloriculture uses following a 

Section 3 Registration Request to Add New Uses on Avocado and Papaya, and 

New Uses for Pome Fruit Group 11 - 10, Cherry sub-group I 2-I 2A, Peach subgroup I 2-I 2B, and Small Fruit Vine Climbing except Fuzzy Kiwifruit Subgroup 

13-07F. 

PC Code: 125501 

Decision No.: 495217 

Petition No.: NA 

DP Barcode: D43 l 534 

Registration No.: NA 

Regulatory Action: Section 3 Registration 

Risk Assessment Type: NA Case No.: NA 

TXR No.: NA CAS No.: 74115-24-5 

MRID No.: NA 40 CFR: NA 

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Risk Assessment Branch VI 

Health Effects Division (7509P) 

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

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

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

APOLLO-it SC Ovicide/Miticide (EPA Reg. No. 66222-47) 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 (11-10), and small fruit vi nes except fuzzy subgroup ( 13-07F). 

Non-cancer dermal and dermal cancer post-application assessments were completed assuming 

the maximum registered label application rates and chemical-specific dislodgeable foliar residue 

(DFR) data (MRJD 43898901) at a rate of0.25 lbs ai/A. 

The crop expansion action prompted an updated review of the toxicology database and an 

occupational exposure reassessment of the existing grape uses associated with the product 

APOLLO® SC Ovicide/Miticide (EPA Reg. No. 66222-47) and existing flori culture uses from 

label Clofentezine SC (EPA Reg. No. 66222-65). Based on current policy, the dermal absorption 

factor for clofentezine was updated from I% to l 0%, which led to the identification of dermal 

post application risks of concern (MOE < I 00) for the grape and floriculture uses. However, the 

two product labels have since been modified to address the risks of concern. Product APOLLO® 

SC Ovicide/Miticide (EPA Reg. No. 66222-47) now prohibits grape girdling and turning 

activities. In addition the label prohibits the following post-application activities; hand 

tying/training. hand harvesting and hand leaf pulling, prior lo 14 days after application for table 

and raisin grapes and 30 days after application for wine and grape juice grapes. Existing 

floriculture uses on label Clofentezine SC (EPA Reg. No. 66222-65) now prohibits hand 

harvesting until after day 3 of application. These label changes are reflected in the following 

updated occupational non-cancer and cancer post-application tables below. These tables replace 

those found in the last occupational assessment (B. Bobowiec. 0429731 l 0/ 16/2015). The acute 

toxicity categories for this chemical require a 12-hour restricted entry interval (REI) under the 

Worker Protection Standard. The 12-hour REI which appears on the proposed label is adequate 

to protect agricultural workers from post-application exposures to clofentezine. 

Page 2 of 4 
Addendum Table 6.2.2. 1 Short-Term Occupational Post-application Dermal Non-Ca ncer Exposure and Risk Estimates for Proposed Clofentezine Uses 

Usine the Hiehest T r a nsfer Coeffi cients. 

Policy Transfer Demial Dose MOE3 

Crop/Site Crop Activities Coefficient DFR1 (mg/lrn./da ,)2 

Group (cm2

/hr.) 0 DAT4 3DAT 7 DAT 15 DAT 30 DAT 0 DAT 3 DAT 7 DAT 15 DAT 30 DAT Category 

Avocado 

99 Hand- 1,400 0.007 0.006 0.006 0.005 0.003 290 310 340 410 590 Papaya 

Floriculture NA Harvesting 4,800 0.024 0.022 0.02 0.017 0.011 84 90 99 120 170 

Stone Fruit ( 12-12) 

Po me Thinning Fruit 3,600 0.018 0.17 0.015 0.13 0.009 110 120 130 160 230 

Fruits ( 11-10) 

Grape, Tying/Training, 0.5 

Wine Hand- ug/cm2 

And Harvesting, 10, 100 0.051 0.047 0.043 0.035 0.025 40 43 47 57 82 

Grape, Hand-Leaf 

Juice ( I 3-07F) Pulling 

Grape, Tying/Training, 

Table HandAnd Harvesting, 5,500 0.028 0.026 0.023 0.019 0.013 73 78 86 100 150 

Grape Hand-Leaf 

Raisin Pulling 

I. DFR = MRID (43898901) 13rady, S.: Kelly, I. (1991) Dissipation of Clofentezinc Foliar Dislodgcable Residlcs Following Application of /\polio SC to Ai:plcs Grown in Washington State, 1989: I.ab 

Project Number: R 152.03.89: 1322-89-101-05-0213-01: 38292,38293. Unpublished stud)' prepared by Northwest /\gricultural Rcseard1. lnc.: l.nndis International. Inc.: and Analytical Oio-Chcmistry 

Labs. Inc. 65 p MRID (43898901) 13rady, S.: Kelly, I. (1991) Dissipntion ofClofentczinc l·oliar Dislodgcablc Residues Following Application of /\polio SC to /\pplcs (i~wn in Washington Stole. 1989. 

2 Daily Dermal Dose = [DFR (~t g/c111 ) x Transfer Coefficient x 0.00 I g/~t g x 8 hrs/day >< dermal absorption ( 10%)] + 13W (80 kg). 

3 MOE= POD (2.0 mg/kg/day) I Daily Denna! Do;l;. 

4. Day after treatment (DAT) 

5 .Boldcd number are risk estimates that exceed concern. 

Page 3 of 4 
Addend um Table 9.2.2.2. Occupational Post-Application Cancer Exposure and Risk Estimates for Proposed New Clofentezine Uses for Avocado a nd 

Papaya Usin2 the Hi2hest Tra nsfer Coefficients. 

Policy Crop 

Transfer Dermal LADD (mg/kg/day)1 Cancer Risk Estimate2 

Crop/Site Activities Coefficient DFR1 30 Day Group Category (cm2/hr.) ODAT 30 Day Average ODAT Average 

Avocado 99 1,400 2.58E-04 l .84E-04 9.7 1 E-06 6.92E-06 Papaya Hand-Harvesting 

Flori culture NA 4,800 0.000883 0.000629777 3.32E-05 2.37E-05 

Stone Fruit ( 12-1 2) Thinning Fruit 3,600 6.64E-04 4.73E-04 2.50E-05 l.78E-05 

Pome Fruits ( 11 - 10) 0.5 

Grape, Wine Tyingfrraining, Hand- ~tg/cm 2 

And 

Grape, Harvesting, Hand-Leaf 10, 100 0.0019 0.0013 7E-05 SE-05 

Juice ( 13-07F) 

Pulling 

Grape, Table Tyingfrraining, I landAnd Harvesting, Hand-Leaf 5,500 0.0010 0.0007 4E-05 3E-05 

Grape Raisin Pulling 

I Denna! I.ADD (mg/kg/day)= Dcrnml dose (mg/kg/duy) x !Days per year of exposure (daysf)r) ._ 365 days/year I x [Years per lifetime of exposure (yis) + Lifetime cxpccrancy ()rs)]. 

2 Daily Dose (mg/kg/day)= DFR (11g/c1112) x 0.00 I mg/ug x Tc (cm21hr) x DA ( I 0%) x ET (8 hr/day)/80 kg 

3 Cancer risk estimate = Dem1al LADD (0 DAT or 30 day a\•cragc doses mg/kg/dl)) x Q1 ·.where Q1 • = 3.76 X 10·1 (mg/kg/day)' 

Page 4 of 4