# UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D.C. 20460 MEMORANDUM Date: May20, 2016 OFFICE OF CHEMICAL SAFETY AND POLLUTION PREVENTION 

# SUBJECT: Clofentezine. Addendum to February2016 HumanHealthRiskAssessment (D423333). CancerAssessments Incorporating Typical Application Rates for Existing Grape and FloricultureUses as well as Tolerance Recommendations for Small FruitVine Climbing ExceptFuzzy Kiwifruit Subgroup 13-07F. PC Code: 125501 DecisionNo.: 495217 PetitionNo.: NA DP Barcode: D433504 RegistrationNo.: NA Regulatory Action: Section 3Registration CaseNo.: NA RiskAssessmentType:NA TXRNo.:NA MRIDNo.:NA CAS No.: 74115-24-5 40CFR:NA FROM: Evisabel Craig, Ph.D., DABT,Risk assessor 

# . e/,**~flAUA/** BridgettBobowiec, Biologist

# ~**~ ~**  

# L Q RiskAssessment BranchVI

# ~ HealthEffects Division (7509P) THROUGH: DonnaDavis, Branch Chief Risk AssessmentBranchVI HealthEffects Division (7509P) TO: Andy Ertman, Chemical ReviewManager BarbaraMadden, TeamLeader MarionJohnson, Branch Chief MinorUse andEmergency Response Branch RegistrationDivision (7505P) And WilhelmenaLivingston,Risk ManagerReviewer TomMyers, TeamLeader Kevin Costello, Branch Chief RiskManagementand ImplementationBranch IV Pesticide Re-evaluationDivision (7508P) Page 1of9

# A Section 3registration wasrequestedby the Interregional Research ProjectNo. 4 (IR-4), in cooperationwiththe registrant, MakhteshimAgan ofNorthAmerica, INC. for use oftechnical clofentezine (EPA Reg. No.74054-1) and the suspension concentrate (SC) formulation APOLLO®SC Ovicide/Miticide (EPA Reg.No.66222-47) containing42% active ingredient on avocado, andpapaya, as well as inclusionofthe crop subgroups; stone fruit (12-12A), and (12- 12B),pomefruits (11-10), and small fruit vines except fuzzy subgroup (13-07F). The mostrecent 2016 clofentezinerisk assessment (E.Craig 

# etal., D423333, 02110/2016) was based oncurrentAgency policy, and updated the dermal absorptionfactor from 1% to 10%. Occupational exposure associated with handler activities (i.e.,mixing, loading, and applying) as well as withpost-applicationactivities (i.e., re-enteringtreated areas) was included in the clofentezine noncancer as well as the clofentezine cancerassessment. Short-term (ST) 1to 30 days and intermediateterm (IT) 1to 6months durations were assessed. Long-term exposures greaterthan 6 months are not anticipated. There wereno occupational exposure risks ofconcern identified for the proposed avocado and papayaincluded in the Section 3action. However,there were dermal post applicationrisks of concern (MOE < 1 00) identified for the previously registered grape and floriculture clofentezine uses. Theregistrant agreedto mitigationmethods including label changesprohibiting grape girdling andturning activities as well as increasingthe reentrytiming for hightransfer coefficientpost 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 arequest to voluntarily cancel EPA RegistrationNo. 66222-65. This memorandum furtherrefines the latestrisk assessmentby incorporating the typical applicationrates provided by the biological and economic analysis division (BEAD) (C. Doucoure,Clofentezine Usage Datato SupportHED'sLifetime Average Daily Dose Calculations,09/20/2011) and (C. Doucoure, Clofentezine (125501) Typical ApplicationRate for Grapesto SupportHED's Occupational Risk AssessmentDP#433503 05116/2016) into the clofentezine cancer assessmentfor bothprivate and commercial occupationalhandlers as well as post-applicationworkers. Occupationalhandler exposure andrisk estimates presented in the tables include various levels ofpersonal protection equipment (PPE). These levels include baseline dermal single layer(SL) which is comprised ofa long sleeved shirt,pants, shoesplus 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), orViton® . A respiratorrequirementdoes not seemwarrantedwiththe currentuse pattern and riskestimates calculated. These three addendum tablesreplace occupational tables found inthe last RAand latest addendumto the risk assessment (E. Craig 

# etal.,D431534, 02/10/2016) as well as the exposure andrisk estimate tables (Tables 6.1.4. 6.1.5, and 9.2.2.2) found in the lastexposure assessment (B. Bobowiec,D429731 , 10/16/2015). Below the addendumtables are followed bythe original tables for comparativepurpose. Page 2 of9Addendum Table 1: Short/Intermediate Term Occupational Commercial Handler C ancer Exposure and Risk Estimates Clofentezine with 10% Dermal Absorption

at Ty pic a l Ap plication Rate s 1 Contract/Commercia l Handler Lifetime Contract/Commerc i a l Handler Co ntrac t/Com mercial Handl er Exposure Scenario Crop I Target Average Dermal Dose and Inh a l at ion Dose Lifetime Average Comb in ed Cance r Ri sk (mg / kg-day) 2 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 SLIG + DLIG +

Equipment + No-R No-R 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 1.75 E-06 3 . 15 E-07 2.48E-07 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-06 5 . 53E-07 4 . 32E-07

LIS C / EC Field crop , 1.6 2E-04 2 .78 E-05 2 . 15E-05 1 .62E-06 1 . 64E-04 2 . 94E-05 2.31 E -05 6.17E-06 I. II E-06 8.69E-07

typical Nursery and 1 . 54E-05 2 . 64E-06 2.04E-06 1 .53E-07 1 .56E-05 2 . 79E-06 2 . 19 E-06 5 . 87E-07 1.05E-07 8.23E-08

Air blast Greenho u se Orchard/Vineyard 8 . 11 E-0 5 1 .39E-05 1 .07E-05 8.08£-07 8.19E-05 1.47 E -05 1.15 E-05 3.08E-06 5.53E-07 4.32E-07 Ap(Jiicator Nursery and 1.65 E-05 3 . 39E -06 2.65E-06 7 . 15E-07 1.72 E-05 4 . 09E-06 3.37E-06 6.47E-07 1 .54E-07 1 .27E-07 Ground Greenhouse boom Orchard/Vineyard 2.90E-05 5.94E-06 4.65E-06 1.25E-06 3.02E-05 7 . 1 9 E -06 5.90E-06 1.14 E-06 2.70E-07 2.22E-07
Spray Field crop , 5.83E-05 1.1 9E-05 9.33 E -0 6 2 . 51 E-06 6.09E-05 1.44E-05 1 . 18 E-05 2.29E-06 5.41 E-07 4.44E-07

typical Nurser y 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-06 4 . 32E-06 4.02E-06

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-05 2 . 27E-05 2 . 1 2E - 05 Mixer/Loader/Applicator Nursery and Backpack Gree nhou se 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-06 1.33E-06 8.05E-07

Christmas Tree farm Manually- Greenhouse and LISC / EC pressurized Nur s ery 2.80E-04 1 . 20 E -06 1.03 E-06 8.41 E-07 2.81 E-04 2.04E-06 1 .87E-06 1 .06E-05 7 . 67E-08 7.03E-08

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-06 2.98E-06 2 . 29E-06 pressurized Christma s Tree Handgun Green hou se 2.45E-04 1.75E-04 1.12E-04 8.41 E-05 3.29E-04 2 . 59E-04 1.96 E-04 1 .24E -05 9.74E-06 7 . 37E-06

--·- - -

I C ommercia l 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 yea r s per lifetime of expos ur e I (365 days / yea r x Lifetime ex pectan cy .

3 Cancer risk es tim ates = LADD * Q, ·, where Q, · = 3 . 76 X 10 · ' (mglkg/day)''.

4 Crops are assessed at the typical rates (F l oric ultur e 0 . 076 lb a i / NO . OOI52 lb ai / ga llon , Orchard crops and grapes assessed at 0.2 lb ai/N0 . 004 l b ai / ga ll on . Formulated clofentezine product s are li quid

concentrates , so lubl e co n centra t e s, or em ul s ifiabl e co n ce nt rates (LISC /E C) .

5 Based on the " Occupational Pesticide Handler Unit Ex p os ure Surrogate Reference Table " (Sep tember , 2015) . Level of mitigation : SL!No G (Single l ayer d e rmal protection consisting of l o n g s leeve s hirt,

long pants , and socks and shoes) no g lov es; SLIG (sing l e la ye r dem1al protectim) plu s the addition of gloves , DL!G (Dou ble la yer dermal protection plu s th e addition of g l oves) , No-R (no r esp irat o r ) Page 3 of9Addendum Table 2: Occupational Private/Farmer Handler Cancer Exposure and Risk Estimates for Proposed Use of Clofentezine Registered Uses with 10% Dermal Absorption and Typical Rates 1

Private /Fa rmer Handler Lifet im e Average Private /Far mer Private /Far mer H and l er Cancer Expos ure Scenario Crop I Target Dermal Do se and Inhalation Dose Lifetime Average Comb ined Dose Ri sk 3

(mg/kg/day) mg/kg-day 2 App li cation Category SL/No G SLIG+ DLIG + SL/No G SLIG + DLIG +

Formu l a tion Equipment SL/No G SLIG D LIG No-R +No -R 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 1.55 E-05 2.79E-06 2.20E - 06 5.83E-07 1.05E-07 8.27E-08 Ground Gree nhou se boom Orchard/Vineyard 2.70E-05 4.62E-06 3.58E-06 2.69E - 07 2.73E-05 4.89E-06 3.85E-06 1.03 E-06 1 .84E- 07 1.45 E-07
LISC / EC Field crop , t yp ic a l 5.4 1 E -05 9.26E-06 7. 17 E- 06 5.38E - 07 5.46E-05 9.80E-06 7.71 E - 06 2.05E-06 3.68E-07 2.90E-07 Nursery ( 5 . 14 E -06 8.79E-07 6.80E-07 5. I I E-08 5. 1 9E - 06 9.3 IE-07 7.3 1 E -07 1.95 E-07 3.50E-08 2.75E-08

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-06 1.84E-07 1.45 E-07 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. 1 6E-07 5. I I E-08 4.2 1 E - 08 Ground Greenhouse boom Orchard/Vineyard 9.66E-06 1.98E-06 I .55E-06 4 . 1 8E-07 1. 0 I E-05 2.40E-06 1.97 E-06 3.80E-07 9.02E-08 7.4 I E-08 Field crop , typical 1.94 E-05 3.97E-06 3.1 I E-06 8.36E-07 2.03E-05 4.81 E-06 3.95E-06 7.63E-07 1 .8 1 E-07 I .49E-07

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 - 06 I .44E-06 I .34E-06

Air blast vege table s , trees ,

container stock) Orchard/Vineyard 2. 1 9E-04 I .95E -04 1.82E-04 5.79E-06 2.25E-04 2.02E-04 I .88E -04 8.46E-06 7.60E-06 7.07E-06 Mixer/Loader/Applicator Nursery a nd Backpack Greenhouse a nd I .23E-05 1.05 E- 05 5.83E-06 I .30E-06 1 .36E-05 I. I 8E-05 7 . 13 E-06 5. 11 E-07 4.44E-07 2.68E-07
Chr i stmas 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-06 2.56E-08 2 . 34E-08
LISC / EC H and wand Greenhouse Mech a nic- Orchard/Vineyard
a ll y- and Nursery and 7.99E-05 2.40E-05 1.78 E-05 2.40E-06 8.24E-05 2.64E-05 2.03E-05 3.10E-06 9.93E-07 7.63E-07

pressurized C hri stmas Tree Hand g un Greenhouse 8. 1 8E-05 5 . 84E-05 3.74E - 05 2 . 80E-05 I . IOE-04 8.64E-05 6 . 54E-05 4. 1 4E - 06 3 . 25E - 06 2.46E-06

-- Private g r owers are assessed assuming I 0 day s of exposure per year. The term " private g rCMier " means that th e growe r or one of the workers would apply the pesticides to l and owned or ope rated by the

g rower.

2 Total LADD = Total Absorbed Dose [Dermal Dos;: + Inh a l ation Dose]* Days per year of exposure X years per lifetime of exposure I (365 days / year x Lifetime expecta nc y .

3 Cancer ri sk estima te s = LADD * Q 1 ' , where Q 1 ' = 3 . 76 X I 0 · 2 (mglkg/day)" 1 .

4 Crops are assessed at the typical rates (F l or i cu l ture 0.076 lb ai / A/0.00 1 52 lb ai l gallon , Orchard crops and grapes assessed at 0.2 lb ai / A/0 . 004 lb ai / ga llon . Form ul ated clofe nt ezine produc t s are liquid

co n ce ntrate s , so luble concentrates , or emu l sifiable concentrates (LISC / EC) .

5 Based o n the " Occupational Pesticide Hand l er U nit Exposure Surrogate Reference Tab l e " (September , 2015) ; Level of mitigation: SL/No G (Sing l e l ayer dermal protection consisting of long s lee\e s hirt ,

long pants , and socks and s h oes) n o g l oves ; SL/G (s in g le layer dermal protectim) p lu s the addition of g l oves , DLIG (Do uble layer dem1al protection plus the addi t ion of gloves) , No-R (no re s pirator) , Page 4 of9Original Table: STa nd IT Term Occup a tional C omm e rcial Handler Cancer Exp osure and Ri s k Estimates C lofentezine with 10 % Dermal Absorption at Maximum Application

Rat e 1 • 6 Co ntr act/Commercia l Handler Lifetime Average Contract/Commercial Handler Co ntr act/Co mmer cia l Handler

Exposure Scenario Lifetime Average Combi ned Dose

Crop I Target Dermal Dose and Inh alat ion Dose (mg/kg / day) 5 (mg / kg-day ; 2 Cancer Ri sk (mg!kg-day?

Category 4 Formulation Application SL/No G SLIG DLIG No-R SL/No G SLIG + DLIG + SL/No G SLIG + DLIG +

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

Mixer/Loader Nursery and 0.00015 0.00003 2.0 1 E-05 1.52E-06 0.00015 2.75E-05 2. 16 E-05 5.79E-06 1.03 E-06 8.12E-07 Ground Greenhouse boom Orchard!V ineyard 0.00010 1.73E-05 1.34 E-05 1 .0 1 E-06 0.00010 1.83 E-05 1.44 E-05 3.87E-06 6.88E-07 5.41 E-07
LISC / EC Field crop , typical 0.00020 3.47E-05 2.68E-05 2.02E-06 0.00021 3.67E-05 2 . 89E-05 7.71 E-06 1 .38E-06 1 .09E -06 Nursery and 5.09E-05 8.67E-06 6.75E-06 5.09E-07 5.13E-05 9.18E-06 7 .27 E-06 1.93 E-06 3.45E-07 2 . 73E-07

Air blast Green hou se

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 3.87E-06 6.88E-07 5.41 E-07 App lic ato r Nursery and 5.46E-05 1 . 12 E-05 8.7E - 06 2.35E-06 5.68E-05 1 .35E-05 I. II E-05 2. 14 E-06 5.08E-07 4. 1 7E -0 7 Ground Greenhouse boom Orchard/Vineyard 3 . 63E-05 7.4 1 E-06 5.83E-06 1 .57E-06 0.00004 0.00001 7 . 41E-06 1 .43E -06 3.38E-07 2.79E-07
Spray Field crop , typical 7.23E-05 1 .49E-05 1 . 16 E-05 3. 1 3E-06 7.56E-05 0.00002 1 . 48E-05 2.84E-06 6.77E-07 5.56E-07

Nursery and 4.09E-04 3.67E-04 3.41 E-04 1.09E-05 4 . 20E-04 3.76E-04 3.52E-04 1 . 58E-05 1.41 E-05 1.32E-05

Air blast Greenhouse

Orchard/Vineyard 8. 1 5E-04 7 . 34E-04 6 . 82E-04 2. 1 7E-05 8 . 37E-04 7.56E-04 7.04E-04 3 . 15 E-05 2.84E-05 2 . 65E-05 Mixer/Loader/Applicator Nur s ery 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 5.08E-06 4.36E-06 2.65E -0 6

Christma s Tree farm Manually- Greenhouse and pressurized Nursery 0 . 00092 3.98E-06 3.37E-06 2 . 77E-06 0.00093 6.75E-06 6 . 1 2E-06 3.48E-05 2 . 54E-07 2 . 3E-07
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 1.16 E-05 3.7 1 E-06 2 . 84E-06

Christmas Tree farm , pressurized Field crop , typical Handgun Green h ouse 8.08E-04 5.75E-04 3.69E-04 2.77E-04 1.08E-03 8.52E-04 6.45E-04 4.06E-05 3.20E-05 2.43E-05

I C ommercia l growers are assessed assuming 30 days of expos ur e per year.

2 Total LADD = Total Absorbed Dose [Dermal Dos: + Inhalation Dose]* Days per year of expos ur e X years per lif etime of exposure I (365 days / year x L if e tim e expec t ancy.

3 C ancer risk estimates = LADD • Q 1 '

, where Q 1 ' = 3 . 76 X 1 0 · 2 (mglkg/day)"' .

4 Crops are assessed at the maximum rate of0.25 lb ai / A or 0 . 005lbs ai / gallon . Typ ical rates were not provided for proposed use .

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

6 Or i ginal Table entitled , " Table 6 . 1.4 Short/Intem1ediate Term Occur.a ti onal Commercia l Hand l er Cancer Exposure and Risk Estimate C l ofentez in e with I 0% Dermal Absorption . " D429731 I 0 / 1 6 / 20 1 5 Page 5 of9Original Table: Occupational Private/Farmer Handler Cancer Exposure and Ri s k Estimates for Proposed Use ofCiofente z ine Registered Uses with 10% Dermal Absorption at Maximum Application Rate 1 • 6

Lifetime Average Private / Farmer Private / Farmer Handler Cancer Exposure Scenario Private / Farmer H a ndl er Lifetime Average Lifetime Average Combined Dose Ri sk 3

Crop I Target Category Dermal Do se and Inhalation Dose (mg/kg / day) (mg/kg - day)2 Formulation Application SL/No G SLIG DLIG No-R SL/No G SLIG + DLIG + SL/No G SLIG + DLIG +

Equ ipment + No-R No-R No-R + 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. 1 7E-06 7.22E-06 1.93E-06 3.45£-07 2.7 1 E -07

GroundOrchard/Vineyard 3.38E-05 5.78E-06 4.47E-06 3.37£-07 3.42£-05 6.11 E-06 4.81 E-06 1.29 E-06 2.3E-07 1 .8 1 £-07
boom Field crop, typical 6.76E-05 1.16 E-05 8.95E-06 6.74E-07 6.82£-05 1 .22E-05 9.63E-06 2.56E-06 4.59£-07 3.62E-07

LISC / EC Nur se ry (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 6.43E-07 1.15 E -07 9. 1 0£-08

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 1 .29E-06 2.30£ - 07 1.81 E -07
Ap plic ato r 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 7 . 11 E-07 1.7 E-07 1 . 39E-07
boom Orchard/Vineyard 1.21 E-05 2.47E-06 1.94 E-06 5.22£-07 1 .27E-05 0.000003 2.47E-06 4.78E-07 1.13E-07 9.29E-08
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 9.48E-07 2.26£ - 07 1.8 5E -0 7

Nur se ry (ornamenta l s, vegetables , trees , container 1.36£-04 1. 22E-04 1 . 14 E-04 3.63£-06 1.40 E-04 1 .25E -04 1.17 E-04 5.26E-06 4.70£-06 4.40E-06

Air bla s t s tock) Orchard/Vineyard 2.72E-04 2 . 45E-04 2.27£-04 7 .24 £-06 2.79E-04 2 . 52£-04 2 . 35E-04 1. 05E-05 9.48£-06 8.84E-06 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 1 .69E-06 1 .46E-06 8 . 84£-07

Christ ma s Tree farmManuallypressurized Nursery and Greenhouse 3.07E-04 1 .33E-06 1 . 12 E-06 9 . 22E-07 3.09E-04 2 . 25E-06 2.04E-06 1.16E-05 8.46E-08 7.67E-08
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 3.87E-06 1.24 E-06 9.48E-07 pressurized Field crop , typical Handgun Greenhouse 2.69E-04 1.92 E-04 1.23 E-04 9.22E-05 3.61E-04 2.84£-04 2.15E-04 1 .36E-05 1 .07£ -05 8.08£-06 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 pesticides t o land ow ned or operated by th e grower.

2 Tota l LADD = Total Absorbed Dose [Dermal Dos:: + Inhal atio n Dose]* Days per year of exposure X years per lifetim e of exposure I (365 days / year x Lifetime expectancy .

3 Cancer risk es timate s = LADD * Q 1 '

, where Q 1 ' = 3.76 X 10 ·' (mglkg / day)" 1 •

4 Crops are assessed a t the maximum rate of 0 .2 5 l b ai / A or 0.005 lb s ail ga llon . Typical rates n ot provided. Formulated c l ofe nt ez ine products are liquid concentra t es , so luble co n centrates , or emulsifiab l e

co nc en trat es (LISC / EC).

5 Based o n th e " Occupational Pesticide Handler Un it E xposure Surrogate Reference Table " (September , 2015) ; Level of mitigation: SL/No G (Si n g l e layer dermal protection co n s istin g of l ong s le e..e s hirt ,

l ong pants , and socks and s hoe s) no g l oves ; SLIG (single la yer dermal protection) plus the additio n of g lov es , DLIG (Double la yer dermal protection p lu s the addition of g l oves) , No-R (no respir ato r ) .

6 Origina l e ntitl ed. " Table 6 . 1.5 Occupational Private / Farmer Handler Cance r Expos ure and Ri sk Esti mat e for Proposed Use of C lof entezi n e Registered Uses wi t h 10 % Derma l Absorption " D429731

I 0 / 1 6 / 20 15 Page 6 of9Addendum Table 3: Occupational Post-Application Cancer Risk Estimates Using the Highest Transfer Coefficients for Clofentezine Using Crop Typical Rate s Polic y Crop Typical Transfer Dermal LADD (mgfkgJdav)i Cancer Ri sk Estimate 2

Crop/Site Group Category App l ication R a te Activities Coefficie nt DFR 1

0 OAT' 0 OAT' ODAT 30 Day

lb ail A (cm 2 /hr . ) 4 Average Avocado 99 0.25 1 ,400 2.58E -04 1 .84E -04 9 .7 1 E-06 6.92E-06 Papaya Hand-Harvesting Floriculture NA 0.076 4 , 800 2.69E -04 1.92 E-04 I E-05 7E-06 Peaches (12-12) 0.17 4.51 E-04 3.22E-04 1 .70E-05 1.21 E -05 Stone Fruit Thinning Fruit 3 , 600 Apples Pome Fruits ( Il-l 0) 0.15 0.5 3 .98 E-04 2.84E-04 1 .50E-05 1 .07E-05 Grape , Wine Tying/Training, llg / cm2

H and-Harvesting , 10 , 100 1 . 49E-03 1 .06E-03 5.60E-05 3.99E-05

And Grape, Juic e Hand-Leaf Pulling

( 1 3-07F) 0.2 Tying/Training , Grape , Table H and-Harvesting, 5,500 8.11 E-04 5.79E-04 3 . 05E-05 2 . 1 8E-05
And Grape R aisin Hand-Leaf Pulling ! Dem1al LADD (mg/kg/day) = Dermal dose (mg/kg/day) x [Da ys p e r year of exposure (days/yr) + 365 days /yea r] x [Y ears per lifetime of exposure (yrs.) + Lifetime expec tanc y (y r s.)].

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

3 Cancer risk es timat e = Dermal LADD (0 DA Tor 30 day average do ses mg / k g/ d!y) x Q 1 ', where Q 1 ' = 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 Tab le: Occupational Post-Application Ca n ce r Ex posure a nd Ri sk Est imat es for Propo se d C lofentezin e Us ing Maximum S ingl e Rate 6 Policy Crop Maximum Transfer Dermal LADD (mg / kg/day) 1 Cancer Risk Estimate 2
Crop / Site Group Sing l e Use Activities Coefficie nt DFR 1

0 OAT' 30 Day ODAT 30 Day

Category Application Rate (cm 2 / hr.) 5 Average Average Avocado 99 1 , 400 2 .58 E-04 1 .84E-04 9.71 E-06 6.92E-06 Papaya Hand-Harvesting

F l oricult ur e NA 4,800 8.85E-04 6.31E-04 3 . 32E-05 2.37E-05 Stone Fruit (12- 12 ) Thinning Fruit 3 , 600 6.64E-04 4.73E-04 2.50E-05 1. 78E-05 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 7E-05 5E-05

Pulling

( 1 3 -0 7F) Gi rdlin g / Turning" 19 , 300 3.56E-03 2.54E-03 1.34 E-04 9.54E-05 Grape , Table Tying/Training , HandAnd Grape Raisin Harvesting , Hand-Leaf 5 , 500 I.OI E -0 3 7.23E-04 3.8 1 E-05 2.72E-05

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 (y r s.) + Lifetime ex p ectancy (yrs.)].

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

3 Ca n cer risk estimate = Dermal LADD (0 DAT or 30 day average doses mg / kg/d!y) x Q1' , where Q 1 ' = 3 . 76 X I o- 2 (mg / kg/dayt 1

4 These activities are now prohibit ed for table and raisin gra p e after app li cation.

5 Transfer coefficien t s shown in table are not inclusive for a ll po s t application ac tiviti es ass um ed for crops but represent the hi g he st ex po s ure .

6 Original table e ntitled , " Table 9.2.2.2. Occupational Post-Application Cancer Exposure and Risk Estimates for Proposed C l ofe ntezine Uses Us in g fle Hi g hest Transfer Coeffic iert s. "

D423333 , 02/1 0 / 20 16 . Page 7 of9

# ToleranceRecommendation Recently,the Registrantpetitioned to expand the tolerance for residues ofclofentezine in grape at 1.0ppmto the crop group fruit, small,vine climbing,exceptfuzzy kiwifruit, Subgroup 13-07F at 1.0 ppm. Atthe time themostrecentrisk assessmentwas completed (E. Craig etal., D423333, 02110/2016),HED couldnot recommend infavor ofestablishing atolerance for this crop subgroupbased onworkerrisks. Subsequently,the Registranthas revised the label. The use rate and PHI remainthe same; therefore, additional residue chemistry data are notrequired to supportthis use. Sincethere are no longerworkerrisks,HED cannowrecommend for a tolerance for residues ofclofentezine in fruit, small,vine climbing,except fuzzy kiwifruit, Subgroup 13-07F at 1.0 ppm. HED notesthat that the tolerance expressions established under40 CFR §180.446 complywiththe HEDInterim Guidance on Tolerance Expressions (S. Knizner, 05/27/2009). Additionally,the currently establishedtolerance for residues in grape should be removed from 40 CFR §180.446 since grapes are a memberofthefruit, small,vine climbing, exceptfuzzy kiwifruit, Subgroup 13-07F. A summary ofthe residue chemistry considerations can befound in Memo, Y. 

# Barnes,D429732 (10-February-2016).

Addendum Table4. ToleranceSummaryfor Clofentezine Proposed Recommended Commodity Tolerance Tolerance Correct Commodity Defmition/Comments (ppm) (ppm) To beestablished under40 CFR §180.446 (a) General. (1) Fruit, small, vine climbing, 1.0 1.0 Establishedtolerance for grape (1 

# ppm) should except fuzzy kiwifruit, be removed from the 40CFRand replaced by Subgroup 13-07F this subgroup tolerance. 

# InternationalHarmonization Therecommended US tolerance of1.0 ppm for the crop subgroup fruit, small,vine climbing, exceptfuzzy kiwifruit, 13-07F does notharmonize withthe CodexMRL of2.0ppm. There is no CanadianMRL for these commodities. The petitionerproposes to establishthe 13-07F subgroup tolerance at 1.0 ppm,whichwould leave the tolerance on grapes at 1.0ppm,the currentUS grapetolerance level,because several countries includingJapan and Korea also maintain an MRL at 1.0ppm.Therefore,HED is recommendingthat the tolerance of1.0 ppmbe established and notes thatthere are issues ofinternational harmonization created bythis approach. 

# DietaryExposure andRisk An

# updated dietary risk assessment is notrequired since the previously conducted dietary assessment included fruit, small,vine climbing,exceptfuzzy kiwifruit, Subgroup 13-07F at 1.0 ppm (Memo, Y. Barnes, D429749; 10-November-2015). Anacute dietary exposure assessment was notperformedas no appropriate endpoints were identified from the available clofentezine toxicity studies indicatingthatclofentezine does notpose an acute dietaryhazard. Partially refined chronic dietary as well as cancerdietaryexposure and risk assessments were performed that directly incorporated average field trial residues, percentcroptreated information, and modelled drinking water estimatedresidues. The estimated exposureto the highestpopulation subgroup (children 1< 2years old)resulted in an estimatedrisk of<1% ofthe chronic populationadjusted dose (cPAD). The estimated exposure to the general U.S. population Page 8 of9

# resulted inan estimatedrisk of<1% ofthe chronicpopulationadjusted dose (cPAD). Applying the 

# Q,

# *of3.76x 1 

# o-2 

# mg/kg/day to the exposurevalue resulted in a cancerrisk estimate of3.8 x 1

# o-7

# to the general U.S. population.

Page 9 of9