### UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHIN G TON , D.C. 2 04 60



### MEM O RAND UM 

### Da t e: Febru a ry 

### I 0 , 2 01 6 OFF I CE OF C H E MI CAL SAFE T Y A N D POL L U TI O N P REVE N T I ON



### SU BJ E C T: C l o fe n t e z in e. Labe l re vi s io ns to ex is tin g g rape and tl o ri c ulture u ses followin g a Sec t ion 3 R eg is tration R eque s t to Add Ne w Uses on Avo c ado and P apaya , and Ne w Uses fo r Pome Frui t Gro up 11

- 10 , Cherry sub-gro up I 

### 2

- I 

### 2A , Peach s ubg ro u p I 

### 2

- I 

### 2 B , and S mall Frui t Vi ne C limb ing e xc ept F uzzy Kiw ifru i t Subgroup 1 3 -0 7 F
. 

### PC Co d e : 1 25501 

### Deci s io n N o. : 4952 1 7 

### Pet i t io n N o. : NA 

### DP B a rco d e : D 43 l 

### 53 4 

### R e gi s t r ati on No .: NA 

### Re g ul atory Actio n : Sec ti o n 3 Reg is tration 

### Case N o.: NA 

### R is k A ss ess me n t T y p e : NA 

### T XR No
. : N A 

### C AS No.: 74115

- 24- 5 4 0 

### CF R : NA MRID 

### No
. : NA
F R OM: Ev i sabc l Crai g , Ph.D
. , DABT , Ri sk assesso r

# ~ ·

# ~**~** Brid ge tt Bo bow ie c , B io log is t

# ~**~** 

# <J Ri s k Assess me nt Bran c h VI 

### Hea lth Effec ts D iv is ion ( 7 509 P ) 

### T HR O UG H : D onn a D av is , B ra nch Ch i e f R is k A ssess me nt Bra nch V I H ea lth Effec t s Di v is ion (7 5 0 9 P ) 

### TO : A nd y E rtm an , C he mic a l Rev iew Ma nage r B a r ba r a Ma dd e n, T e am Lead er M arion J o hn so n, Branch C hi ef Min o r Us e and Em er ge ncy Res po nse Bran c h R eg is trati o n Di v is ion (750 5 P) And W il he lm e na Li v in gs ton , Ri sk M anage r R ev ie w er To m My ers . Tea m Lead er K

ev in C o s te ll o . Bran c h C hi ef Ri sk Ma nage m e nt a n d Impl e me nt at io n Branc h IV Pes ti cid e Re - eva lu ation Di v is io n (750 8P ) Pa ge 1 

### o f 4A Section 3 reg istration was reque s ted by th e Inte rregional R esearch Project No. 4 (IR-4), in cooperation with the registrant , Makhteshim Agan of North America, INC. for use of technica l clofentezine (EPA R eg. No. 74054 -l ) and the suspension concentrate (SC) formulation APOLLO -it SC Ovicide/Miticide (E PA Reg. No. 66222-47) containing 42% active ingredient on avocado , and papaya, as well as inclusion of th e crop s ub groups: stone fruit (12- 1 2A) , and ( 1 2- 12B), pome fruits (11-10), and small fruit vi n es except fuzzy s ub group ( 13-07F). Non-cancer dermal and dermal cancer post-application assessments were completed assuming the maximum registered label app lic ation rates and chemical-specific di slodgeab le foliar residue (DFR) data (M RJD 43898901) at a rate of0.25 lbs ai/A. The crop expansio n action prompted an updated review of the toxicology databa se and an occupationa l exposure r eassess ment of th e ex i s ting grape u ses associated with the product APOLLO ® SC Ovicide / Miti cide (EPA R eg. No. 66222-47) and ex i st in g flori c ulture use s 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 app li cation risks of concern (MOE < I 00) for the grape and floriculture uses. However, the two product label s have s in ce been modifi ed to address the ri sks of concern. Product APOLLO ® SC Ovicid e/Mi ticide (E PA R eg. No. 66222-47) now prohibits grape girdling a nd 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 ra i sin grapes and 30 days after app l ication for wine and grape juice grapes. Existin g floriculture uses on label Clofentez ine 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-appl ication table s below. These tables replac e those found in the last occupationa l assessment ( B. Bobowi ec. 0429731 l 0 / 16 / 2015)
. The acute toxicity categories for this chemical require a 12-hour restricted e ntr y int erval (REI) under the Worker Protection Standard. The 1 2 -h our 

### REI w hich appears on the proposed label is adequate to protect agricultural workers from post-application exposures to clofentezine.

Pa ge 2 of 4Addendum Tab l e 6.2.2
. 1 S h o rt-T e rm Occupati o nal Po s t-applicati o n D e rma l No n- Ca n ce r Exposure and Ri s k Est im ates for Prop ose d C l ofentez in e Uses Us in e the Hieh est T r a n s fer Coe ffi c ie nts. Poli cy Tran sfer Demial Do se MOE3 C rop/ S ite C r op Activ it ies Coefficient DFR 1 (mg/ lrn

./ da , ) 2 Group (cm 2 / hr. ) 0 DAT4 3DAT 7 DAT 1 5 DAT 30 DA T 0 DAT 3 D AT 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 Papa ya Floricultur e NA Harve s ting 4 , 800 0.024 0.022 0.02 0.017 0.011 84 9 0 99 120 170 Stone Fruit ( 12-12) Po m e Thinning Fruit 3,600 0.018 0.17 0.015 0.13 0.009 1 10 120 130 160 23 0 Fruit s ( 11-10) Grape, Tying/Training, 0.5 Win e Hand- u g/ cm 2 And Harv es ting , 10 , 100 0.051 0.047 0.043 0.035 0.025 40 4 3 4 7 57 82 Grape , Hand-L ea f Juice ( I 3-07F) Pulling Grape , T y in g / T r a inin g, Table HandAnd Harve s ting , 5,500 0.028 0.026 0.023 0.019 0.013 73 78 86 100 1 50 Grape Hand-L eaf Rai s in Pullin g I
. DFR = MRID (4 3 898901) 13rad y, S.: Ke ll y , I. ( 1 99 1 ) Diss ip ati o n o f C lofe ntezin c Foliar Dis lo dgcable Re s idlc s Foll o wing Ap plicat ion o f /\poli o SC t o A i:plc s G r own in Washington Sta te , 19 89: I.ab Project N umber : R 152 .03. 89 : 1322-89- 10 1-05

- 02 13- 01: 38292,38293. U npublished stud) ' pr epared by N orthwe s t /\ g ri c ultural Rcseard1
. ln c.: l.nndi s Internati o nal
. In c .: and Anal y tical Oio-Chcmi stry Labs. Inc
. 65 p MRID (43 89890 1) 13rady , S
. : Kelly , I. ( 199 1 ) Dis s ipntion ofClofentcz in c l·o liar Dis lodgcablc Residu es Following Application o f /\po li o SC t o /\pplc s**(i~w n**  in Washington Stole
. 1 989
. 2 Dai l y Dermal Dose = [DFR**(~t g/** **c111 )**  x Transfer Coefficient x 0
. 00 I**g/ ~t** **g** x 8 hrs/ da y >< dermal absorp ti on ( 10%) ] + 13W (80 k g). 3 MO E= POD (2
.0 mg/kg/da y) I Dail y Denna! Do;l;. 4. Day after treatment ( DAT ) 5
. B oldcd number are ri sk e stimate s that exceed co ncern .



### Page 3 of 4Ad d e n d um Tabl e 9.2.2
. 2. Occupational Post-App l ication Ca n ce r Ex p os ur e and Ri s k Es tim ates for Propo se d New C lo f e n tezine Uses for A voca do a n d Papa ya U s in 2 t h e Hi2h est Tr a n s fer Coeffic ie nt s. Polic y C r o p Tra n sfe r D e rmal LADD (mg/kg/day) 1 Ca nc e r Ri s k Es timat e 2 Crop/ Site Activities Coeffic i en t DFR 1 30 Day Group Category (c m 2 /hr.) ODAT 30 Da y Average ODAT Average Avocado 99 1,400 2.5 8E

- 04 l .84E-04 9.7 1 E

- 06 6.92E

- 06 Papaya H a nd

- Harv es tin g 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-0 5 l. 78E-05 Pom e Fru it s ( 11

- 1 0) 0.5 Grape , Wine T y ingfrraining , H and-**~tg/cm 2**  And Grape, Harvesting, H and-Leaf 10 , 100 0.0019 0.0013 7E-05 SE-05 Jui ce ( 13-07F) Pullin g Grape, Table Tyingfrraining, I l and

And Harv es tin g, Hand-Leaf 5,500 0.0010 0.0007 4E -05 3E -05 Grape Rai s in Pullin g I Denna ! I.ADD (mg/kg/ day)= Dcrnm l dose (mg/kg/duy) x !Days per year of exposure ( daysf)r) ._ 365 day s/year I x [Years per lifetim e of ex p osu re (yis) + L ifetime cxpccrancy ()rs) ]

. 2 Dail y D ose (mg/kg/day)= DFR ( 11 g/c 1112 ) x 0.00 I m g/u g x Tc (c m 21 hr ) x DA ( I 0%) x ET (8 hr / da y) / 80 kg 3 Ca n ce r risk estimate = Dem1al LA DD (0 DAT or 30 da y a\ • cragc d oses m g/kg/ dl )) x Q 1 ·.where Q 1 • = 3

. 76 X 10· 1 ( m g/kg/day)'



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