Novaluron Summary of Analytical Chemistry and Residue Data DP#: 364237

Page 1 of 43 UNITED STATES ENVIRONMENTA L PROTECTION AGENCY

WASHINGTON, D.C. 20460 OFFICE OF PREVENTION, PESTICIDE S,

AND TOXIC SUBSTANCES MEMORANDUM Date : 0 4 - DEC - 2009 SUBJECT: Novaluron . Petition for the Establishment of Permanent Tolerances for Residues

of Novaluron in/on Vegetable , Fruiting, Group 8; Vegetable, Cucurbit, Group 9; Berry, Low - growing, Subgroup 13 - 07G ; Miscellaneous Fruiting Vegetables; Bean, Snap; Bean, Dry , Seed; and Swiss Chard . Summary of Analytical Chemistry and Res idue Data . PC Code: 124002 DP Barcode: D364237 Decision No.: 407555 Registration No. : 66222 - 35 Petition No.: 9E7546 Regulatory Action: Section 3 Registration Risk Assessment Type: NA Case No.: NA T XR No.: NA CAS No.: 116714 - 46 - 6 MRID Nos .: 47705801 - 47705808 40 CFR: §180.598 FROM : Julie L . Van Alstine , MPH, Environmental Health Scientist

Risk A ssessment B ranch 1 (RAB1) /Health Effects Division (HED) (7509P) THROUGH : George F. Kramer, Ph.D., Senior Chemist

RAB1/HED (7509P) TO: Barbara Madden/Laura Nollen (RM 05)

Registration Division (RD; 7505P) Executive Summary Novaluron, a benzoylphenyl urea compound, is a pesticide chemical belonging to the class of insecticides called insect - growth regulators (IGR). It is currentl y registered for uses on pome fruits, Brassica head and stem vegetables, tuberous and corm vegetables, cotton, tomatoes, and sugarcane. Registrations on bushberry subgroup 13 - 07B, Brassica , leaf y greens (subgroup 5B), turnip greens, and stone fruit (crop group 12) are pending. The basic producer of novaluron is Makhteshim - Agan of North America (MANA). End - use products containing novaluron as the active ingredient (ai) are formulated as an emuls ifiable concentrate (EC), suspension concentrate (SC), or water - dispersible granular (WDG). Under petition 9E7546, the Interregional Research Project Number 4 (IR - 4), on behalf of the Agricultural Experiment Stations of AR, CA, FL , GA, KY, MA, NM, NC, OK, PA, PR, SC, TN, and TX, requests the establishment of a permanent tolerance for residues of the insecticideNovaluron Summary of Analytical Chemistry and Residue Data DP#: 364237

Page 2 of 43 novaluron, 1 - [3 - chloro - 4 - (1,1,2 - trifluoro - 2 - trifluoro - methoxyethox y)phenyl] - 3 - (2,6 - difluorobenzoyl)urea, in/on:

Vegetable, fruiting, group 8 ................................ .......... 1.1 ppm Vegetable, cucurbit, group 9 ................................ ....... 0.25 ppm Berry , low growing, subgroup 13 - 07G ....................... 0.50 ppm Cocona ................................ ................................ .......... 1.1 ppm Eggplant, African ................................ .......................... 1.1 ppm Eggplant, pea ................................ ................................ . 1.1 ppm Eggplant, scarlet ................................ ............................ 1.1 ppm Goji berry ................................ ................................ ...... 1.1 ppm Huckleberry , garden ................................ ...................... 1.1 ppm Marty nia ................................ ................................ ........ 1.1 ppm Naranjilla ................................ ................................ ....... 1.1 pp m Okra ................................ ................................ ............... 1.1 ppm Roselle ................................ ................................ ........... 1.1 ppm Sunberry ................................ ................................ ........ 1.1 ppm Tomato, bush ................................ ................................ . 1.1 ppm Tom ato, currant ................................ ............................. 1.1 ppm Tomato, tree ................................ ................................ .. 1.1 ppm Bean, snap, succulent ................................ .................. 0.60 ppm Bean, dry ................................ ................................ ..... 0.2 0 ppm Swiss chard ................................ ................................ .... 12 ppm The end - use product associated with these registration requests is Rim o n ® 0.83 EC Insecti ci de (EPA Reg. No. 66222 - 35), an EC formulation containing 9.3% ai (equivalent to 0.83 lb ai/gal). Rim o n ® is proposed for application on members of the fruiting vegetable group 8 at a maximum seasonal rate of 0.23 lb ai/A with 7 - day retre atment intervals (RTI s) and a 1 - day preharvest interval (PHI). For cucurbit vegetable group 9, applications of Rimon ® at a maximum seasonal rate of 0.23 lb ai/A with 14 - day RTIs and a 1 - day

PHIis proposed. The label for cucurbits also proposes the use o f a non - ionic surfactant ; however the field trials were conducted without the use of a surfactant . There are separate use directions for strawberry and the remaining commodities in low - growing berry subgroup 13 - 07G. For strawberries, applications of Rimo n ® at a maximum seasonal rate of 0.23 lb ai/A with 14 - day RTIs and a 1 - day

PHIis proposed . For the remaining commodities in the low - growing berry s ubgroup 13 - 07G , applications of Rimon ® at a maximum seasonal rate of 0.23 lb ai/A with a 7 - day RTI and 1 - day PHI is proposed. For snap and dry

beans, applications of Rimon ® at a maximum seasonal rate of 0.23 lb ai/A with 7 - day RTIs and a 1 - day

PHI is proposed. For Swiss chard, applications of Rimon ® at a maximum seasonal rate of 0.23 lb ai/A with 7 - day RTIs and a 1 - day

PHI is proposed. The label states that no surfactants should be used with Rimon ® on snap and dry beans and Swiss chard. A revised Section B is requested which specif ies that the use of adjuvants /surfactants (including non - ionic surfactants) on fruiting vegetable group 8 , cucurbit vegetable group 9 , low - growing berry subgroup 13 - 07G , and strawberry is prohibited and include s a statement which prohibits the use of novaluron on crops grown for food in greenhouses , except tomatoes . The revised S ec tion B should also correct “lowbush berry” to “lowbush blueberry” in the low - growing berry subgroup 13 - 07G section of the label. Tolerances have been established for residues of novaluron under 40 CFR § 180. 598 . The tolerance expression for both plants and livestock is in terms of the insecticide novaluron only .Novaluron Summary of Analytical Chemistry and Residue Data DP#: 364237

Page 3 of 43 Residue tolerances have been established for novaluron in/on cotton, Brassica head and stem vegetables (subgroup 5A), pome fruit (group 11), tuberous and corm vegetables (subgroup 1C) , tomatoes, and sugarcane at levels ranging from 0.05 to 30 ppm. Tolerances are pending for bushberry subgroup 13 - 07B (7.0 ppm), Brassica leafy greens subgroup 5B (25 ppm), turnip gr eens (25 ppm), and stone fruit crop group 12 except cherries (1.9 ppm), cherries (8. 0 ppm), and dried plum (2.6 ppm). Residue tolerances for novaluron in/on livestock have been established at 20 ppm (milk fat), 11 ppm (fat of cattle, goat, horse, and sheep), 1.0 ppm (milk and kidney and liver of cattle, goat, horse, and sheep), 0. 60 ppm [ meat and meat b yproducts (except liver and kidney) of cattle, goat, horse, and sheep ] , 0.40 ppm (poultry fat), 0.05 ppm (egg and hog fat), 0.04 ppm (poultry

meat by products), 0.03 ppm (poultry meat), and 0.01 ppm (meat and meat by products of hog). A time - limited tolerance, with an expiration date of 31 - DEC - 20 11 , is established in association with a Section 18 Emergency Exemption for strawberries at 0. 50 ppm. The exemption tolerance for strawberries will be superseded b y the new proposed use on bushberry crop subgroup 13 - 07G . The nature of the residue in plants is understood based on acceptable plant metabolism studies reflecting foliar uses on apples, cabbage, cotton, and potatoes. HED has previously concluded that the residue of concern in plants is novaluron only for tolerance enforcement and risk assessment (Memo , G. Kramer et al. , 03 - FEB - 2004; D297646) . HED also previousl y concluded that the nature of the residue in livestock is adequatel y understood based on the submitted goat and poultry metabol ism studies (Memo, G. Kramer, 22 - MAR - 2004; D285474). The HED MARC determined that the residue of concern in livestock for purposes of tolerance enforcement and risk assessment is novaluron only (Memo, G. Kramer et al. , 03 - FEB - 2004; D297646). The availabl e confined rotational crop study is adequate. The HED Metabolism Assessment Review Committee (MARC) has determined that for tolerance assessment and risk assessment, parent onl y is the residue of concern (Memo , G. Kramer et al. , 03 - FEB - 2004; D297646) . Ba sed on the results of the confined rotational crop study, the appropriate plantback interval (PBI) for all non - labeled crops is 30 days. The current and proposed labels include a restriction that only registered crops may

be rotated to a treated field within 30 days of the final application, which is appropriate for this petition. There are adequate residue anal ytical methods for the enforcement of residue tolerances. F or anal ys is of crop matrices for residues of novaluron , gas chromatography/ electron - capture detection (GC/ECD) and high -performance liquid chromatography /ultraviolet (HPL C/UV) methods are available. These methods have undergone successful validation by the Anal ytical Chemistry

Branch of the Biological and Economics Analysis Division (ACB /BEAD) and have been forwarded to Food and Drug Administration (FDA) for inclusion in the Pesticide Anal ytical Method Volume II (PAM II). The GC/ECD enforcement method (with minor modifications) was used for data - collection in the anal ys is of sampl es co llected from the bell and non - bell pepper , cantalo upe, summer squash, strawberry , snap bean, dry bean , and Swiss chard field trials . The method was adequatel y validated in conjunction with the studies . Cucumber samples were anal yz ed using a method based on Py

xant Labs Inc. mass spectrometry (MS) method number METH1585 - 00.00, entitled “ Determination of Novaluron in Crop Matrices b y L C/MS/MS.” The method has not beenNovaluron Summary of Analytical Chemistry and Residue Data DP#: 364237

Page 4 of 43 previously

reviewed ; however , it is similar to the GC/ECD enforcement method . The method was adequatel y validated in conjunction with the cucumber study . The requirements for Multiresidue Methods (MRMs) testing data for novaluron are fulfilled. The available data indicate that novaluron could not be recovered through application of the multiresidue protocols. There are adequate storage stability data to validate the storage conditions and durations of samples collected from the bell pepper, cucumber, cantaloupe, summer squash, strawberry , snap bean, dry bean, and Swiss chard field trials . Previously submitted storage stability data indicate that novaluron is reasonably stable for at least 5 - 12 months under frozen storage in/on apples, broccoli, cabbage, pears, potatoes, tomatoes , blueberries, turnip greens, and peaches . In addition, con current storage stability data were submitted confirming the stability of novaluron residues in/on bell pepper for 6.7 months (204 days), cantaloupe for 7.0 months (214 day s), summer squash for 9.4 months (286 day s), strawberry for 11.7 months (355 days), snap bean pods with seeds for 8.6 months (263 day s), snap bean foliage for 8.7 months (264 day s), dry bean seed for 5.0 months (151 day s), and Swiss chard for 11.7 months (356 day s) . Concurrent storage stability data for cucumbers and non - bell peppers wer e not generated. Current A gency

regulatory

guidelines require that stability of residues for the duration of storage be shown either in the requested crop (or representative crop) or in at least five diverse crops. While freezer storage stability data have not been submitted for the duration of cucumber storage , pome fruits (apple) and fruiting vegetables (tomato ) contain relatively high water content and residues in/on these commodities are expected to have similar stability when frozen [ Organization for Economic Cooperation and Development (OECD) Guideline for the Testing of Chemicals

– Stability

of Pesticide Residues in Stored Commodities; adopted by OECD 16 October 2007 ] . As such, the freezer storage stability data on apple and tomato may be extended to cucumbers for the purpose of these residue trials. The concurrent storage stability study for bell peppers may

be translated to non - bell peppers. The submitted field trial residue data for bell and non - bell peppers, cucumbers, cantaloupe, summer squ ash, strawberries, snap beans, dry bean seed , and Swiss chard are adequate to support the establishment of the requested crop/ subgroup tolerance s . There are no processing studies associated with the current petition. Therefore, a discussion of processe d commodities is unnecessary . The field trial data were entered into the Agency ’s maximum residue l imits (MRL) tolerance spreadsheet to determine appropriate tolera nces. The maximum - likelihood estimation (MLE) spreadsheet was used for bell peppers, non - bell peppers, cantalou pe, summer squash, and dry bean seed . The output from the tolerance spreadsheet supports the IR- 4 proposed tolerance of 0.60 ppm for residues of novaluron in/on snap beans and 12 ppm for residues of novaluron in/on Swiss chard . The tolerance spreadsheet output did not support IR- 4’s proposal of 1.1 ppm for residues of novaluron in/on vegetable, fruiting, crop group 8 and miscellaneous fruiting vegetables; 0.25 ppm for vegetable, cucurbit, crop group 9; 0.50 ppm for berry , low - growin g , crop subgroup 13 - 07G; and 0.20 ppm for dry bean seed. The appropriate tolerances are 1.0 ppm for residues of novaluron in/on vegetable, fruiting, crop group 8 and miscellaneous fruiting vegetables; 0.15 ppm for vegetable, cucurbit, crop group 9; 0.45 ppm for berry , low - growing , subgroup 13 - 07G; and 0.3 0 ppm for dry bean seed.Novaluron Summary of Analytical Chemistry and Residue Data DP#: 364237

Page 5 of 43 No Codex, Canadian , or Mexican MRL s have been established for novaluron in/on the proposed commodities . Canada is currentl y in the process of reviewing the use of novaluron on strawberries, snap beans, and bell and non - bell peppers . EPA and PMRA tolerance recommendations have been harmonized at 0.45 ppm for low - growing berry subgroup 13 - 07G and 0.60 for edible -podded snap beans. The PMRA has not received petitions for the use of novaluron on fruiting vegetable group 8 and will be setting tolerances for bell and non - bell peppers at 0.80 ppm and 0.90 ppm, respectivel y (personal communic ation with Melissa Watchorn of PMRA, 30 -NOV - 2009 ) . Regulatory Recommen dations and Residue Chemistry Deficiencies Pending submission of revised Sections B and F (see requirements under Directions for Use and Proposed Tolerances) , there are no residue chemistry issues that would preclude granting an unconditional registration for the use of novaluron on the requested crops. The proposed uses and the submitted data support the following permanent tolerances for residues of the insecticide novaluron , including its metabolites and degradates, in or on the commodities in the ta

ble below. Compliance with the tolerance levels specified below is to be determined b y measuring only novaluron ( N - [[[3 - chloro - 4 - [1,1,2 - trifluoro - 2 - (trifluoromethox y)ethox y]phenyl]amino]carbonyl] - 2,6 - difluorobenzamide ) in or on the following raw agricultural commodities (RACs) : Vegetable, cucurbit, group 9 0.15 ppm Okra 1.0 ppm Vegetable, fruiting, group 8 1.0 ppm Roselle 1.0 ppm Cocona 1.0 ppm Sunberry 1.0 ppm Eggplant, African 1.0 ppm Tomato, bush 1.0 ppm Eggplant, pea 1.0 ppm Tomato, currant 1.0 ppm Eggplant, scarlet 1.0 ppm Tomato, tree 1.0 ppm Goji berry 1.0 ppm Berry, low - growing, subgroup 13 - 07G 0.45 ppm Huckleberry, garden 1.0 ppm Bean, snap, succulent 0.60 ppm Martynia 1.0 ppm Bean, dry, seed 0.30 ppm Naranjilla 1.0 ppm Swiss chard 12 ppm A human - health risk assessment is forthcoming in a separate document ( D 363988 ) . 860.1200 Directions for Use A revised Section B for petition number 9E7546 should be submitted which:

 Specifies that the use of adjuvants /surfactants (including non - ionic surfactants) on fruiting vegetable group 8, cucurbit vegetable group 9 , strawberry , and lo w - growing berry subgroup 13 - 07G is prohibited;  Corrects “lowbush berry” to “lowbush blueberry” in the low - growing berry subgrou p 13 - 07G section o f the label ; and  States that the use of novaluron on crops grown for food in greenhouses , except tomatoes, is prohibited. 860.1550 Proposed Tolerances  The proposed tolerance expression for petition number 9E7546 is written in terms of “tolerances for co mbined residues of the insecticide novaluron, 1 - [3 - chloro - 4(1,1,2 -Novaluron Summary of Analytical Chemistry and Residue Data DP#: 364237

Page 6 of 43 trifluoro - 2 - trifluoro - methoxyethox y) phenyl ] - 3 - (2,6 - difluorobenzoyl)urea . ” A revised Section F for petition number 9E7546 should be submitted to remove the word combined and cite the appropriate CAS name for novaluron:

“ Tolerances are established for residues of the insecticide novaluron , including its metabolites and degradates, in or on the commodities in the table below. Compliance with the tolerance levels specified below is to be deter mined by measuring only novaluron (

N - [[[3 - chloro - 4 - [1,1,2 - trifluoro - 2 - (trifluoromethox y)ethox y]phenyl]amino]carbonyl] - 2,6 - difluorobenzamide ) in or on the following raw agricultural commodities:”

 A revised Section F is requested which reflect s the recommen ded tolerances and commodity

definitions presented in Table 20 . Note s to RD: The currently established tomato tolerance and the time - limited tolerance for strawberry

should be removed from 40 CFR §180.598. Additionally , the pending tolerance for bushb erry subgroup 13 - 07B (7.0 ppm) should be amended to “bushberry subgroup 13 - 07B, except lowbush blueberry .” Background The chemical structure and nomenclature of novaluron is listed in Table 1. The physicochemical properties of the technical grade of novaluron are presented in Table 2. Table 1. Novaluron Nom enclature .

Chemical structure O N H N H O F

F Cl O O C F 3 F F F Common name Novaluron IUPAC name 1 - [3 - chloro - 4 - (1,1,2 - trifluoro - 2 - trifluoromethoxyethoxy)phenyl] - 3 - [2,6 - difluorobenzoyl]urea CAS name N - [[[3 - chloro - 4 - [1,1,2 - trifluoro - 2 - (trifluoromethoxy)ethoxy]phenyl]amino]carbonyl] - 2,6 - difluorobenzamide CAS registry number 116714 - 46 - 6 End - use product s (EP s ) Rimo n® 0.83 EC Insecticide (0.83 lb/gal EC; EPA Reg. No. 66222 - 35)Novaluron Summary of Analytical Chemistry and Residue Data DP#: 364237

Page 7 of 43 Table 2. Physicochemical Prop erties of Technical Grade Novaluron. Parameter Value Reference Melting range 176.5 - 178.0  C

DP# 315780, 3 -NOV - 2005, S. Levy pH 6.5 Density 1.56 g/cm3 at 22  C Water solubility 3 μg/L at 20  C Solvent solubility (at 25  C) 0.00 839 g/L in n - heptane 1. 88 g/L in xylene 14.5 g/L in methanol 198 g/L in acetone 113 g/L in ethyl acetate 0.98 g/L in n - octanol Vapor pressure (mm Hg) 1.2 x 10 - 7 Dissociation constant, pKa Not determined due to low water solubility . Octanol/water partition coefficient, Log( KOW) 4.3 at 25  C UV/visible absorption spectrum Molar absorption coefficients of at 3 maximum absorbances: 15,400 L/mol  cm

at 253 nm (neutral) 9,780 L/mol  cm at 253 nm ( acidic) 20,500 L/mol  cm

at 263 nm (basic) 860.1200 Directions for Use IR- 4 has submitted a draft label, dated 16 - MAR - 20 0 9 , for Rim o n ® 0.83 EC Insecti ci de ( EPA Reg. No. 66222 - 35) to include the proposed new use s (see Table 3) on fruiting vegetable group 8, cucurbit vegetable group 9, low - growing berry subgroup 13 - 07G, cocona, African eggplant, pea eggplant, scarlet eggplant, g oji berry , garden huckleberry , martynia, naranjilla, okra, roselle, sunberry , bush tomato, currant tomato, tree tomato, snap beans, dry bean s eed , and Swiss chard . Table 3. Summary of Directions for Use o f Novaluron. Application Equipment Form

ulation [EPA Reg. No.] Applic.

Rate (lb ai/A) Max. No.

Applic. per Season Max.

Seasonal Applic. Rate (lb ai/A) PHI

(days) Use Directions and

Limitations Fruiting Vegetables (field) [tomatoes (including bush, currant, and tree tomatoes ) , peppers, eggplants (including African, pea, and scarlet eggplants), tomatillo, groundcherry, pepino, okra, cocona, g oji berry, garden huckleberry, martynia, naranjilla, roselle, and sunberry] Groundboom/ Aerial 0.83 lb/gal

EC [66222 - 35] 0.058 -

0.078 3 - 4 1 ,2,3 0.23 1 Repeat applications as needed to protect new foliage growth, blooms, and fruit, but not less than 7 days apart. 1 - day PHI; 12 - hour REI. Low - Growing Berry Subgroup 13G [cranberry, lingonberry, muntries, partridgeberry, bear berry, bilberry , low bush berry, and cloudberry] Groundboom/ Aerial 0.83 lb/gal

EC [66222 - 35] 0.078 3 3 0.23 1 Repeat applications as needed to protect new foliage growth, blooms, and fruit, but not less than 7 days apart. 1 - day PHI; 12 - hour REI.Novaluron Summary of Analytical Chemistry and Residue Data DP#: 364237

Page 8 of 43 Table 3. Summary of Directions for Use o f Novaluron. Application Equipment Form

ulation [EPA Reg. No.] Applic.

Rate (lb ai/A) Max. No.

Applic. per Season Max.

Seasonal Applic. Rate (lb ai/A) PHI

(days) Use Directions and

Limitations Strawberry Groundboom/ Aerial 0.83 lb/gal

EC [66222 - 35] 0.058 -

0.078 3 - 4 0.23 1 Repeat applications as needed to protect new foliage growth, blooms, and fruit, but not less than 14 days apart. 1 - day PHI; 12 - hour REI. Swiss Chard

Groundboom/ Aerial 0.83 lb/gal

EC [ 66222 - 35] 0.058 -

0.078 3 - 4 3 0.23 1 Repeat applications as needed to protect new foliage growth, blooms, and fruit, but not less than 7 days apart. Do not use surfactants of any kind with Rimon® 0.83EC on this crop. 1 - day PHI; 12 - hour REI. Beans (Snap, Dry)

Groundboom/ Aerial 0.83 lb/gal

EC [66222 - 35] 0.039 -

0.078 3 - 6 2,3 0.23 1 Repeat applications as needed to protect new foliage growth, blooms, and fruit, but not less than 7 days apart. Do not use surfactants of any kind with Rimon® 0.83EC on this crop. 1 - day PHI; 12 - hour REI. Cucurbit Vegetables [balsam apple, balsam pear, chayote (fruit), cantaloupe, cucumber, Chinese cucumber, gherkin (West Indian), edible gourd, melon, citron melon, muskmelon, bittermelon, pumpkin, squash, summer squash, winter squas h, watermelon, and Chinese waxgourd]

Groundboom/ Aerial 0.83 lb/gal

EC [66222 - 35] 0.058 -

0.078 3 - 4 2,3 0.23 1 Repeat applications as needed to protect new foliage growth, blooms, and fruit, but not less than 14 days apart. Use of a non ionic surfactant to enhance coverage and penetration may improve performance. 1 - day PHI; 12 - hour REI. 1 For the Colorado potato beetle, no more than two applications should be made to a single generation and it should not be applied to successive generations. 2 No more than two applications against whiteflies or thrips per season should be used. 3 For most effective control, fields should be scouted . For ground applications to vegetables, a minimum spray volume of 10 gallons per acre (GPA) should be used. Aerial applications are to be made in 2 - 10 GPA . For orchard spraying, applications by

conventional ground sprayers should be no less than 75 GPA for tree s less than 10 feet tall, and 100 to 400 GPA on trees greater than 10 feet tall. Applications of Rim o n ® 0.83 EC may also be made through sprinkler irrigation sy stems; use of other ty pes of irrigation sy stems are prohibited. The accepted (master) label for Rim o n ® 0.83 EC Insecticide states that only registered crops may

be rotated in a treated field within 30 day s of a pplication. The currentNovaluron Summary of Analytical Chemistry and Residue Data DP#: 364237

Page 9 of 43 and proposed labels include a restriction that only registered crops may

be rotated to a treated field within 30 days of the final application. Rim o n ® may be applied alone, as a tankmix, or in rotation with other registered insecticides. The label states that no surfactants should be used with Rimon ® on snap and dry b eans and Swiss chard. A revised Section B is requested which specif ies that the use of adjuvants /surfactants (including non - ionic surfactants) on fruiting vegetable group 8, cucurbit vegetable group 9 , low - growing berry subgroup 13 - 07G , and strawberry is prohibited and include s a statement which prohibits the use of novaluron on crops grown for food in greenhouses , except tomatoes . The revised section B should also c orrect “lowbush berry” to “lowbush blueberry” in the low - growing berry subgroup 13 - 07G section of the label. Conclusions : The proposed label is adequate to allow evaluation of the residue data relative to the proposed new uses on fruiting vegetable group 8, cucurbit vegetable group 9, low - growing berry crop subgroup 13 - 07G, cocona, African eggplant, p ea eggplant, scarlet eggplant, g oji berry , garden huckleberry , martynia, naranjilla, okra, roselle, sunberry, bush tomato, currant tomato, tree tomato, sn ap beans, dry beans , and Swiss chard . A r evised Section B is requested which :  Specifies that the use of adjuvants /surfactants (including non - ionic surfactants) on fruiting vegetable group 8, cucurbit vegetable group 9 , strawberry , and low - growing berry subgroup 13 - 07G is prohibited;  Corrects “lowbush berry” to “lowbush blueberry” in the low - growing berry subgrou p 13 - 07G section of the label ; and  States that the use of novaluron on crops grown for food in greenhouses , except tomatoes, is prohibited. 860.1300 Nature of the Residue - Plants MARC Decision Memo , DP# 297646, 2/3/04, G.F. Kramer Residue Chemistry Memo, DP# 285474 , 3/22/04 , G.F. Kramer (PP#2F6430 ) HED previousl y (PP#2F6430) concluded that the nat ure of the residue in plants is adequatel y understood based on acceptable metabolism studies conducted on apples, cabbage, cotton, and potatoes using [difluorophenyl - U 14 C]novaluron and [chlorophenyl - U 14 C]novaluron as the test substances. These studies indicate that novaluron is not extensively metabolized in these crops. The parent compound, novaluron, was either the only residue component identified or was the predominant residue component in all anal yz ed plant matrices. The reviewed studies also indi cate novaluron, when foliarly applied during the vegetative growth stage, is not readil y translocated to mature apple fruit, potato tubers, or cottonseed. The HED MARC ( 0 3 - FEB 20 04) determined that the residue of concern in crops for purposes of tolerance enforcement and risk assessment is novaluron only . 860.1300 Nature of the Residue - Livestock HED also previousl y concluded that the nature of the residue in livestock is adequatel y understood based on the submitted goat and poultry metabolism studies ( Memo, G. Kramer, 22 - MAR - 2004; D285474). The HED MARC determined that the residue of concern in livestock forNovaluron Summary of Analytical Chemistry and Residue Data DP#: 364237

Page 10 of 43 purposes of tolerance enforcement and risk assessment is novaluron only (Memo, G. Kramer et al. , 03 - FEB - 2004; D297646). 860.1340 Residue Analytic al Methods Residue Chemistry Memo, DP# 285474 , 3/22/04 , G.F. Kramer (PP#2F6430 ) Residue Chemistry Memo, DP# 306998, 9/15/04 , S. Levy ( PMV Results ) Residue Chemistry Memo, DP# 307595, 9/15/04 , S. Levy ( PP#2F6430; Memo to FDA) Residue Chemistry Memo, DP#s 3 22978 & 315780 , 11/3/05 , S. Levy (PP# 4E6834 ) Residue Chemistry Memo, DP# 325183, 8/23/06 , S. Levy ( PP#4E6834; Radiovalidation) Enforcement Method

s: MANA previousl y submitted under PP#2F6430 a GC/ECD residue anal ytical method for the anal ys is of residues of novaluron in/on pome fruit, cabbage, and potato commodities. Briefl y, residues in/on homogenized crop samples are extracted with methanol/water. The filtered extracts are concentrated to aqueous and repeatedly partitioned with he xane. The resulting hexane fractions are cleaned up b y chromatography through an amino solid -phase extraction (NH 2 - SPE) cartridge, the eluate is evaporated to dry ness, and residues are redissolved in ethyl acetate or hexane for anal ys is by GC/ECD. The validated limits of quantitation (LOQs) are 0.01 ppm for residues in/on potatoes and 0.05 ppm for residues in/o n apples (including juice and wet pomace) and cabbage. A second method, HPLC/UV, was submitted for the anal ys is of novaluron residues onl y in/on c otton commodities. Similarly , samples are extracted with a cetonitrile (ACN) or ACN/water, and repeatedl y partitioned with hexane, or dichloromethane and then hexane. The resulting ACN fraction is cleaned up by gel -permeation chromatography (GPC), silica - gel chromatography, and/or NH 2 - SPE for HPL C/UV anal ys is. The validated LOQ is 0.05 ppm for undelinted cottonseed, cotton gin by products, and the processed commodities of hulls, meal , and refined oil. Successful independent laboratory validations (ILVs) o f the GC/ECD and HPL C/UV methods have been completed with apples and undelinted cottonseed, respectively . Acceptable radiovalidation data have been submitted and reviewed in D 325183 for the GC/ECD method . An interference study

was requested and a specifi c single - anal yt e confirmatory method was submitted, reviewed, and considered acceptable (Memo, J. Langsdale, 21 - OCT - 200 8; D 355574) . The ACB concluded that based upon review of the submitted method validation data, without laboratory

validation, that the G C/ECD and HPL C/UV methods appear suitable for food tolerance enforcement in plants (apples, cabbage, potatoes) and cotton. ACB recommended that the anal ytical methods do not need to be la boratory validated by

EPA (DP 306998). Both methods have been forwarded to the FDA for inclusion in the PAM II as a Letter Method (D307595). Pepper (Bell and Non -Bell) Data - Collection: Samples of peppers were analyzed for residues of novaluron using the GC/ECD enforcement method. Briefl y, homogenized pepper samples were extracted using methanol:water (70:30, v:v), filtered, partitioned into hexane, and cleaned up through a NH 2 - SPE column . Residues of novaluron were quantitated b y GC/ECD . The method was adequately validated using samples of untreated bell pepper fortifi ed with novaluron at 0.05 - 5 ppm. In addition, the method was validated concurrently with the analysis of field samples, using samples of untreated pepper (bell and non - bell) fortified with novaluronNovaluron Summary of Analytical Chemistry and Residue Data DP#: 364237

Page 11 of 43 at 0.05 ppm. The lowest level of method validation (LLM V) was 0.05 ppm for novaluron in/on bell and non - bell pepper. Cucumber Data - Collection: Samples of cucumber were anal yz ed for residues of novaluron using a high -performance liquid chromatography method with tandem mass - spectrometry detection (LC/MS/MS; Pyx ant Method METH1585.00 - 00). Method METH1585 - 00.00 has not been previousl y reviewed by the EPA; however it is similar to the GC/ECD method previously proposed for enforcement purposes . Briefl y, samples of cucumber were extracted twice using methanol:w ater (70:30, v:v). The extract was filtered and diluted with extraction solvent for LC/MS/MS analy sis. Prior to the anal ys is of field samples, the method w as validated using samples of untreated cucumber fortified with novaluron at 0.05 - 25.2 ppm. In a ddition, the method w as validated concurrently

with the analysis of field samples, using samples of untreated cucumber fortified with novaluron at 0.05 and 25 ppm . The LLMV was 0.05 ppm for novaluron residues in/on cucumber. Cantaloupe Data - Collection: Samples of cantaloupe were anal yz ed for residues of novaluron using a method similar to the GC/ECD enforcement method. Briefl y, homogenized cantaloupe samples were extracted using methanol:water (70:30, v:v), filtered, partitioned into ethyl acetate , and cleaned up through an NH 2 - SPE column . Residues of novaluron were quantitated by GC/ECD . Prior to the anal ys is of field samples, the method w as validated using samples of untreated cantaloupe fortified at 0.05 - 5.0 ppm. In addition, the method w as validat ed concurrently with the anal ys is of field samples, using samples of untreated cantaloupe fortified at 0.05 and 0.5 ppm. The LLMV was 0.05 ppm for novaluron residues in/on cantaloupe . Summer Squash Data - Collection: Samples of summer squash were anal yz ed for residues of novaluron using a method similar to the GC/ECD enforcement method. Briefly , homogenized summer squash samples were extracted using methanol:water (70:30, v:v), filtered, partitioned into ethyl acetate, and cleaned up through an NH 2 - SPE co lumn. Residues of novaluron were quantitated by

GC/ECD . Prior to the anal ys is of field samples, the method w as validated using samples of untreated summer squash fortified at 0.05 - 5.0 ppm. In addition, the method w as validated concurrentl y with the anal ys is of field samples, using samples of untreated summer squash fortified at 0.05 and 0.5 ppm. The LLMV was 0.05 ppm for novaluron residues in/on summer squash. Strawberry Data - Collection: Samples of strawberry were analyzed for residues of novaluron us ing a method similar to the GC/ECD enforcement method. Briefl y, homogenized strawberry samples were extracted using methanol:water (70:30, v:v), filtered, partitioned into ethyl acetate, and cleaned up through an NH 2 - SPE column. Residues of novaluron were quantitated by GC/ECD . Prior to the anal ys is of field samples, the method was adequatel y validated using samples of untreated strawberry

fortified with novaluron at 0.05 - 5.0 ppm. In addition, the method was validated concurrentl y with the anal ys is of f ield samples, using samples of untreated strawberry fortified with novaluron at 0.05 - 5.0 ppm. The LLMV was 0.05 ppm for novaluron in/onNovaluron Summary of Analytical Chemistry and Residue Data DP#: 364237

Page 12 of 43 strawberry . Snap Bean Data - Collection: Samples of snap bean were anal yz ed for residues of novaluron using a method similar to the GC/ECD enforcement method. Briefl y, homogenized snap bean samples were extracted using methanol:water (70:30, v:v), filtered, homogenized again using only methanol, partitioned into hexane, and the hexane extracts were evaporated using a Turbo Vap. The sample was then brought to a final volume with hexane and analyzed for residues of novaluron using GC/EC without a SPE cleanup step. Prior to the anal ys is of field samples, the method was validated using samples of untreated snap bean pods with seeds and snap bean foliage fortified with novaluron at 0.050 - 5.0 ppm. In addition, the method was validated concurrentl y with the analysis of field samples, using samples of untreated snap bean pods with seeds fortified with novaluron at 0.05 and 0 .50 ppm and untreated snap bean foliage fortified with novaluron at 0.05 - 30.0 ppm. The LLMV was 0.05 ppm for novaluron in/on both snap bean pods with seeds and snap bean foliage. Dry Bean Seed Data - Collection: Samples of dry bean seed were analyzed for residues of novaluron using the GC/ECD enforcement method. Briefl y, homogenized dry bean seed samples were extracted using methanol:water (70:30, v:v), filtered, partitioned into h exane, and cleaned up through a NH 2 - SPE column. Residues of novaluron were quantitated by GC/ECD . Prior to the anal ys is of field samples, the method was validated using samples of untreated bean seed fortified with novaluron at 0.05 - 5 ppm. In addition, the method was validated concurrentl y with the anal ys is of field samples, using samples of untreated bean seed fortified with novaluron at 0.05 and 0.5 ppm. The LLMV was 0.05 ppm for novaluron in/on dry bean . Swiss Chard Data - Collection: Samples of Swiss chard were anal yz ed for residues of novaluron using a method similar to the GC/ECD enforcement method. Briefl y, homogenized Swiss chard samples were extracted using methanol:water (70:30, v:v), filtered, partitioned into hexane, and concentrated . Residues of novaluron were quantitated by GC/ECD . Prior to the anal ys is of field samples, the method was validated using samples of untreated Swiss chard fortified with novaluron at 0.05 - 10 ppm. In addition, the method was validated concurrently

with the analysis of field samples, using samples of untreated Swiss chard fortified with novaluron at 0.05 - 5.0 ppm. The LLMV was 0.05 ppm for novaluron in/on Swiss chard. Conclusions : HED previously concluded that the submitted GC/ECD method is adequate as an enforcement method for novaluron, the terminal residue of concern in plant s (apple, cabbage, cotton, and potato). The enforcement method, with minor modifications, was used for data collection and the method s w ere adequately validated in conjunction with the bell and non - bell pepper, cucumber, cantaloupe, summer squas h, strawberry , snap bean , dry bean seed , and Swiss chard field trials associated with the new use s discussed herein. 860.1360 Multiresidue Methods Residue Chemistry Memo, DP# 322359, 10/19/2005 , S. Levy ( PP#2F6430 ) Novaluron was tested through the FDA MRM Test gui delines in PAM I, Appendix II (JAN 19 94). The results indicate that novaluron is not adequatel y recovered b y any of the MRMs.Novaluron Summary of Analytical Chemistry and Residue Data DP#: 364237

Page 13 of 43 This study

was forwarded to FDA for further evaluation and updating of PAM Vol. I , Appendix I. 860.13 80 Storage Stability Residue Chemistry Memo, DP# 285474 , 22 - MAR - 04 , G.F. Kramer (PP# 2F6430) Residue Chemistry Memo, DP# 357060, 09 - SEP - 2009, J.L. Van Alstine (PP# 8E7425) Storage stability

data for novaluron were presented in PP#2F6430. These data show that fortified residues of novaluron are reasonably stable under frozen conditions in/on pears for up to 5.2 months; broccoli, cabbage , and tomato for up to 6 months; apple and potato for up to 12 months; and apple juice for up to 3.3 months. Additional co ncurrent storage stability data was submitted for blueberries , mustard green s , and peach es in PP# 8E7425 , which demonstrate d that fortified residues of novaluron are relativel y stable under frozen conditions in/on blueberry , mustard greens, and peaches for up to 150 days , 4 64 days, and 116 day s, respectively . In conjunction with the subject bell pepper, cantaloupe, summer squash, strawberry , snap bean, dry bean seed , and Swiss chard field trial studies, concurrent storage stability data were generated whi ch demonstrate that fortified residues of novaluron are relatively stable under frozen conditions in/on bell pepper for 6.7 months ( 204 days ) , cantaloupe for 7.0 months ( 214 days ) , summer squash for 9.4 months ( 286 days ) , strawberry for 11.7 months ( 355 days ) , snap bean pods with seeds for 8.6 months ( 263 days ) , snap bean foli age for 8.7 months ( 264 days ) , dry bean seed for 5.0 months ( 151 days ) , and Swiss chard for 11.7 months ( 356 days ) . Although no 0 - day data were provided with the concurrent storage st ability data for these commodities , no additional data will be required in consideration of the stability of novaluron in/on other crop matrices. Concurrent stora g e stability data for cucumbers and non - bell peppers were not generated. Current A gency

regulatory

guidelines require that stability of residues for the duration of storage be shown either in the requested crop (or representative crop) or in at least five diverse crops. While freezer storage stability data have not been submitted for the duratio n of cucumber storage, pome fruits (apple) and fruiting vegetables (tomato) contain relatively high water content and residues in/on these commodities are expected to have similar stability when frozen [OECD Guideline for the Testing of Chemicals

– Stabili ty of Pesticide Residues in Stored Commodities; adopted by OECD 16 October 2007]. As such, the freezer storage stability data on tomato and apple may be extended to cucumbers for the purpose of these residue trials. The freezer storage stability study fo r bell peppers may be translated to non - bell peppers. The storage durations and conditions of samples from the crop field trial s tudies submitted to support this petition are presented in Table 4 . Table 4 . Summary of Storage Conditions and Durations o f Samples from Crop Field Trial s. Matrix Storage Tem perature (°C) Actual Storage

Duration Interval of Demonstrated Storage Stability Bell pepper - 29 to - 15 85 - 164 days (2.8 - 5.4 months) Up to 204 days for residues of novaluron

in/on frozen bell pepper (concurrent storage stability data). Non - bell pepper - 29 to - 15 78 - 153 days (2.6 - 5.0 months) Translated from bell pepper [ up to 204 days

for residues of novaluron in/on frozen bell pepper (concurrent storage stability data) ] .Novaluron Summary of Analytical Chemistry and Residue Data DP#: 364237

Page 14 of 43 Cucumber ≤ - 20 61 - 142 days (2.0 - 4.7 months) Translated from tomato (residues of

novaluron are stable in/on tomato stored frozen for up to 6 months 1 ). Cantaloupe - 40 to - 6 86 - 164 days 2 (2.8 - 5.4 months) Up to 214 days for residues of novaluron

in/on frozen cantaloupe (concurrent storage stability data). Summer squash - 40 to - 6 192 - 283 days 2 (6.3 - 9.3 months) Up to 286 days for residues of novaluron

in/on frozen (concurrent storage stability data). Strawberry - 40 to - 2 49 - 235 days 3 ( 1.6 - 7.7 months) Up to 355 days for residues of novaluron

in/on frozen strawberry (concurrent storage stability data). Snap bean pods with seeds - 21 ± 7 175 - 228 days 4 (5.7 - 7.5 months) Up to 263 days for residues of novaluron

in/on frozen snap bean (concurrent storage stability data). Snap bean foliage - 21 ± 7 175 - 228 days 4 (5.7 - 7.5 months) Up to 264 days for residues of novaluron

in/on frozen snap bean foliage (concurrent storage stability data). Dry bean seed - 21 ± 7 98 - 147 days 4 (3.2 - 4.8 months) Up to 151 days for residues of novaluron

in/on frozen dry bean (concurrent storage stability data). Swiss chard - 21 ± 7 54 - 242 days 5 (1.8 - 8.0 months) Up to 356 days for residues of novaluron

in/on frozen Swiss chard (concurrent storage stability data). 1 Refer to D 285474 , G. Kramer, 22 - MAR- 2004. 2 Actual storage duration from harvest to analysis. Samples were analyzed within 0 - 10 days of extraction. 3 Actual storage duration from harvest to analysis. Samples were analyzed within 1 - 16 days of extraction. 4 Actual storage duration from harvest to analysis. Samples were analyzed within 0 - 5 days of extraction. 5 Actual storage duration from harvest to analysis. Samples were extracted and analyzed on the same day . Conclusions : Inconjunction with previously submitted storage stability data for novaluron on a variety of crops, the concurrent storage stabili ty conducted with the bell pepper, cantaloupe, summer squash, strawberry , snap bean , dry bean seed , and Swiss chard field trials will support the sample conditions and durations of storage for th ese studies. The freezer storage stability data on tomato and apple may be extended to cucumbers and the bell pepper freezer storage stability data may be translated to non - bell peppers for the purpose of these residue trials. 8 60.1480 Meat, Milk, Poultry, and Eggs There are no livestock feed items associated with the proposed uses. 860.1500 Crop Field Trials Pepper (Bell and Non - Bell) DER Reference : 47705801.der.doc S ix bell pepper field trials were conducted in the U.S. in North American Free Trade Agreement (NAFTA) Growing Zones 2 (GA; 1 trial), 3 (FL; 1 trial), 5 (OH; 1 trial), 6 (TX; 1 trial), and 10 (CA; 2 trials ) and three bell pepper trials were conducted in Canada in NAFTA Growing Zones 5 (ON; 2 trials) and 5B (QC; 1 trial). Four non - bell pepper field trials were conducted in the U.S. in NAFTA Growing Zones 3 (FL; 1 trial), 5 (OH; 1 trial), 6 (TX; 1 trial), and 10 (NM; 1 trial). Each trial site consisted of one untreated plot and one or two treated plots. At each trial site, three broadcast or directed spray applications of a 0.83 lb/gal EC formulation of novaluron (Rimon ® 0.83EC; EPA Reg. No. 66222 - 35 ) were made to pepper plants at 0.077 - 0.084 lb ai/ANovaluron Summary of Analytical Chemistry and Residue Data DP#: 364237

Page 15 of 43 per application, with 6 - to 8 - day RTIs, for a total rate of 0.2 34 - 0.245 lb ai/A. At four bell pepper sites, a second plot was treated with a 0.83 lb/gal SC formulation of novaluron ( Pedestal ® Novaluron Insecticide; EPA Reg. No. 66222 - 40) in the same manner. Applications were made using ground equipment in 31 - 51 GPA spray volumes, without an adjuvant. Samples were harvested at commercial maturity, 1 day after the last application of novaluron, except for one ON trial where samples were collected 2 days after the last application. At the GA trial, additional samples were collected 4, 8, and 11 days after the last application to evaluate residue decline. The results (see Table 11 ) indicate that residues of novaluron ranged from <0.05 to 0.37 ppm in/on 18 samples of treated bell pepper and from <0.05 to 0.36 ppm in/on 8 samples of treated non - bell pepper when treated with an EC formulation at a total seasonal rate of 0.234 - 0.245 lb ai/A and harvested at a 1 - day PHI ( 2 - day PHI for 1 bell pepper sample). Following foliar treatments with the SC formulation at a total seas onal rate of 0.238 - 0.244 lb ai/A, residues of novaluron ranged from <0.05 to 0.28 ppm in/on 8 samples of treated bell pepper when harvested at a 1 - day PHI. In the residue decline trial, average residues of novaluron decreased from 0.29 ppm at the 0 - day PHIto 0.22 ppm at the 4 - day PHI , and then increased to 0.28 and 0.37 ppm at the 8 - and 11 - day PHI s, respectivel y. Overall, the residue decline trial indicated that residues generall y staye d the same with increasing PHIs for bell peppers. The side - by- sid e field trial data indicate the use of the SC formulation will yield similar residues in/on bell and non - bell pepper commodities as the use of the EC formulation. TABLE 11 . Summ ary of Residue Data fromCrop Field Trials with Novaluron (Bell and Non - Bell Peppers) . Commodity Total Applic. Rate

(lb ai/A) [g ai/ha] PHI

(days) Residue Levels 1 (ppm)

n Min. Max. HAFT 2 Median Mean Std. Dev. Treated with EC formulation Pepper, bell 0.234 - 0.244

[262.2 - 273.5] 1; 2 3 18 <0.05 0.37 0.37 0.07 0.14 0.11 Pepper, non bell 0.240 - 0.245

[269.0 - 274.6] 1 8 <0.05 0.36 0.35 0.13 0.16 0.13 Treated with SC formulation Pepper, bell 0.238 - 0.244

[266.8 - 273.5] 1 8 <0.05 0.28 0.28 0.05 0.11 0.10 1 For calculation of HAFT, median, mean , and standard deviation, the LLMV (0.05 ppm) was used for all residues report ed as below the LLMV. 2 HAFT = highest - average field trial. 3 At one trial site, samples were harvested 2 days after last application. Conclusions : The number and locations of field trials are in accordance with OPPTS Guideline 860.1500 for bell pepper, as a representative commodity for fruiting vegetable crop group 8 (excluding cucurbits) . Field trial data for tomato (the other representative crop of the fruiting vegetable crop group) have been submitted previously ( Memo, G. Kramer, 7 - FEB - 2008; D379033). For non - bell pepper s , the correct number of field trials was conducted, but no trials were conducted in the region which accounts for 50% of non - bell pepper production (Zone 8). HED notes that although no non - bell p epper field trials were conducted in Zone 8, IR - 4 did conduct one more field trial than was requested. In addition, since the maximum non - bell pepper residues are less than the maximum bell pepper residues and tomatoes drive the tolerance forNovaluron Summary of Analytical Chemistry and Residue Data DP#: 364237

Page 16 of 43 fruiting veg etable crop group 8, HED will not request field trial data for non - bell peppers in Zone 8. The field trial data reflect the proposed use rate and PHI for fruiting vegetable group 8. The field trial data for bell and non - bell pepper were entered into the Agency ’s MLE spreadsheet and then the Agency ’s MRL tolerance spreadsheet as specified b y the Guidance for Setting Pesticide Tolerances Based on Field Trial Data SOP to determine appropriate tolerance levels; see Appendix I . Tolerance values of 0.80 ppm fo r bell pepper and 0.90 ppm for non - bell pepper were calculated. However, as these values are the less than as the previously set tolerance for tomato (1.0 ppm), separate tolerances for bell and non - bell pepper will not be required and the recommended tole rance for residues of novaluron in/on fruiting vegetable group 8 is 1.0 ppm . Cucumber DER Reference: 47705802.der.doc Six cucumber field trials were conducted in NAFTA Growing Zones 2 (GA, NC; 1 trial each), 3 (FL; 1 trial), 5 (M I, OH; 1 trial each), and 6 (TX; 1 trial). Each trial site consisted of one untreated plot and one treated plot. At each trial site, three foliar applications of a 0.83 lb/gal EC formulation of novaluron (EPA Reg. No. 66222 - 35) were made at 0.075 - 0.085 lb ai/A per application, with 7 - to 10 - day RTIs, for a total rate of 0.230 - 0.249 lb ai/A. All applications were made as broadcast applications. Applications were made using ground equipment in 20 - 28 GPA spray volumes, without an adjuvant. Samples were harvested at commercial m aturity , one day after the last application of novaluron. Additional treated samples were also collected at one cucumber trial 0, 3, 5, and 7 days after the last application to evaluate residue decline. The results (see Table 12 ) indicate that followin g foliar treatments with the 0.83 lb/gal EC formulation at a total season al rate of 0.230 - 0.249 lb ai/A with a 1 - day PHI, residues of novaluron were below the LOQ (<0.05 ppm) in/on 12 samples of treated cucumber. Residues of novaluron were below the LOQ ( <0.05 ppm) in/on all cucumber samples from the decline trial. TABLE 12 . Summ ary of Residue Data fromCrop Field Trials with Novaluron (Cucumber) . Commodity Total Applic. Rate

(lb ai/A) [g ai/ha] PHI

(days) Residue Levels (ppm) 1

n Min. Max. HAFT 2 M edian Mean Std. Dev. Cucumber 0.230 - 0.237

[258 - 266] 1 12 <0.05 <0.05 <0.05 0.05 0.05 -- 1 For calculation of the HAFT, median, mean, and standard deviation, the LOQ (0.05 ppm) was used for residues reported <LOQ. Standard deviation was not calculated fo r data sets where all reported values were <LOQ. 2 HAFT = highest - average field trial. Cantaloupe DER Reference: 47705802.der.doc Eight cantaloupe trials were conducted in NAFTA Growing Zones 2 (NC; 1 trial), 5 (WI ; 1 trial), 6 (TX; 2 trials) , and 10 ( CA; 4 trials). Each trial site consisted of one untreated plot and one treated plot. At each trial site, three foliar applications of a 0.83 lb/gal EC formulation of novaluron (EPA Reg. No. 66222 - 35) were made at 0.075 - 0.085 lb ai/A per application, with 13 - to 16 - day RTI s, for a total rate of 0.230 - 0.249 lb ai/A. All applications were made as broadcast applications with the following exceptions: at the CA23 trial, all three applications were made as foliar- directed applications; and at the CA24 trial, the first application was made as a foliar-Novaluron Summary of Analytical Chemistry and Residue Data DP#: 364237

Page 17 of 43 direction application. Applications were made using ground equipment in 33 - 42 GPA spray volumes, without an adjuvant. Samples were harvested at commercial maturity , one day after the last application of novaluro n. Additional treated samples were also collected at one cantaloupe trial 4, 8, and 9 days after the last application to evaluate residue decline. The results (see Table 13 ) indicate that following foliar treatments with the 0.83 lb/gal EC formulation at a total seasonal rate of 0.230 - 0.249 lb ai/A with a 1 - day PHI, residues of novaluron ranged from <0.045 to 0.093 ppm in/on 16 samples of treated cantaloupe . It is noted that the cantaloupe trial in which all applications were made as foliar- directed applications yi elded the samples with the maximum residues. In the residue decline trials, average residues appeared to decrease slightly in/on cantaloupe with increasing sampling intervals; however, residues in/on all samples were near the LOQ. TABLE 13 . Summary of Residue Data fromCrop Field Trials with Novaluron (Cantaloupe) . Commodity Total Applic. Rate

(lb ai/A) [g ai/ha] PHI

(days) Residue Levels (ppm) 1

n Min. Max. HAFT 2 Median Mean Std. Dev. Cantaloupe 0.239 - 0.245

[268 - 275] 1 16 <0.045 0.093 0.091 0.045 0.055 0.018 1 For calculation of the HAFT, median, mean, and standard deviation, the LOQ (0.045 ppm for cantaloupe) was used for residues reported <LOQ. 2 HAFT = highest - average field trial. Summer Squash DER Reference: 47705802.der.doc Seven summer squash trials were conducted in NAFTA Growing Zones 2 (NJ, NC; 1 trial each), 3 (FL; 1 trial), 5 (WI; 1 trial), 6 (TX; 1 trial), 10 (CA; 1 trial), and 11 (WA; 1 trial). The NJ summer squash trial was conducted near the border to Zone 1. Each trial site consisted of one untreated plot and one treated plot. At each trial site, three foliar applications of a 0.83 lb/gal EC formulation of novaluron (EPA Reg. No. 66222 - 35) were made at 0.075 - 0.085 lb ai/A per application, with 12 - to 15 - day RTIs , for a total rate of 0.230 - 0.249 lb ai/A. All applications were made as broadcast applications with the following exceptions: at the CA145 trial, the first application was made as a foliar- direction application; and at the FL13 trial, the first two appl ications were made as foliar- directed applications. Applications were made using ground equipment in 32 - 45 GPA spray volumes, without an adjuvant. Samples were harvested at commercial maturity, one day after the last application of novaluron. No residue decline study was completed for summer squash. The results (see Table 14 ) indicate that following foliar treatments with the 0.83 lb/gal EC formulation at a total seasonal rate of 0.230 - 0.249 lb ai/A with a 1 - day PHI, residues of novaluron ranged from <0.039 to 0.074 ppm in/on 14 samples of treated summer squash. TABLE 14 . Summ ary of Residue Data fromCrop Field Trials with Novaluron (Summer Squash) . Commodity Total Applic. Rate

(lb ai/A) [g ai/ha] PHI

(days) Residue Levels (ppm) 1 n Min. Max. HAF T 2 Median Mean Std. Dev. Summer s quash 0.240 - 0.249

[269 - 279] 1 14 <0.039 0.074 0.071 0.039 0.044 0.012 1 For calculation of the HAFT, median, mean, and standard deviation, the LOQ (0.039 ppm) was used for residues reported <LOQ.Novaluron Summary of Analytical Chemistry and Residue Data DP#: 364237

Page 18 of 43 2 HAFT = highest - averag e field trial. Conclusions: The number and locations of field trials are in accordance with OPPTS Guideline 860.1500 for cucumber, cantaloupe, and summer squash as representative crops of cucurbit vegetable group 9 . The field trial data reflect the prop osed use rate and PHI for cucurbit vegetable group 9 . The field trial data for cantaloupe and summer squash were entered into the Agency ’s MLE spreadsheet and then the Agency ’s MRL tolerance spreadsheet as specified by the Guidance for Setting Pesticide T

olerances Based on Field Trial Data SOP to determine appropriate tolerance levels; see Appendix I . Because the cucumber residues were all below the L OQ (0.05 ppm) , the MLE and MRLspreadsheets were not used for cucumber . The tolerance spreadsheet recommended a tolerance of 0.15 ppm for cantaloupe and 0.09 ppm for summer squash. The available data support a tolerance of 0.15 ppm for residues of novaluron in/on cucurbit vegetable group 9 . Strawberry DER Reference: 4770580 5 .der.doc Ten strawberry

trials were conducted in the U.S. and Canada in NAFTA Growing Zones 1 (NY; 1 trial), 2 (NJ; 1 trial), 3 (FL ; 1 trial), 5 (ON; 1 trial), 5A (WI ; 1 trial), 5B (QC; 1 trial), 10 (CA; 3 trials), and 12 (OR; 1 trial) during the 2007 growing season. Each trial site c onsisted of one untreated plot and one treated plot. At each trial site, three broadcast or directed spray applications of a 0.83 lb/gal EC formulation of novaluron (Rimon ® 0.83EC; EPA Reg. No. 66222 - 35) were made to strawberry plants at 0.077 - 0.084 lb ai/A per application, with 7 - to 10 - day RTIs, for a total application rate of 0.238 - 0.251 lb ai/A. Applications were made using ground equipment in 50 - 125 GPA spray volumes, without an adjuvant. Samples were harvested at commercial maturity, one day after the last application of novaluron. At the ON trial, additional samples were collected 0, 3, 5, and 8 days after the last application to evaluate residue decline. The results (see Table 15 ) indicate that following foliar treatments with the 0.83 lb/gal EC formulation at a total seasonal rate of 0.238 - 0.251 ai/A, residues of novaluron ranged from <0.05 to 0.287 ppm in/on 20 samples of treated strawberry when harvested at a 1 - day PHI . In the residue decline trial, average residues of novaluron increased fro m 0.153 ppm at the 0 - day PHI to 0.174 ppm at the 1 - day PHIand then decreased at later sampling intervals, to 0.110 ppm at the 8 - day PHI. Overall, the residue decline trial indicated that residues generally stayed the same with increasing PHIs for strawberries. TABLE 15 . Summ ary of Residue Data fromCrop Field Trials with Novaluron (Strawberry) . Commodity Total Applic. Rate

(lb ai/A) [g ai/ha] PHI

(days) Residue Levels 1 (ppm)

n Min. Max. HAFT 2 Median Mean Std. Dev. Strawberry 0.238 - 0.251

[267 - 2 81] 1 20 <0.05 0.287 0.250 0.116 0.140 0.071 1 For calculation of the median, mean, and standard deviation, the LLMV (0.05 ppm) was used for residues reported as below the LLMV. 2 HAFT = highest - average field trial.Novaluron Summary of Analytical Chemistry and Residue Data DP#: 364237

Page 19 of 43 Conclusions: The number and locations of field trials are in accordance with OPPTS Guideline 860.1500 for strawberry as the representative crop of the low - growing berry subgroup 13 - 07G . The field trial data reflect the proposed use rate and PHIfor strawberry . The label contains separate us e directions for the remaining commodities in the low - growing berry subgroup 13 - 07G. The total use rates and PHI for these remaining commodities are equal to the use rates and PHIfor the strawberry

field trials ; however, the RTIis 7 day s as opposed to 1 4 days for strawberries. Although the RTIfor the remaining low - growing berry subgroup 13 - 07G commodities is less than the strawberry RTI, these commodities are covered by the strawberry field trials because the strawberry field trials were conducted usin g 7 - to 8 - day RTIs . The field trial data for strawberry were entered into the Agency ’s tolerance spreadsheet as specified b y the Guidance for Setting Pesticide Tolerances Based on Field Trial Data SOP to determine appropriate tolerance levels; see Appen dix I . The available data support a tolerance of 0.45 ppm for residues of novaluron in/on low - growing berry subgroup 13 - 07G . Snap Bean DER Reference: 4770580 6 .der.doc Fourteen snap bean trials were conducted in the U.S. and Canada in NAFTA Growing Zon es 1A (NS; 1 trial), 2 (MD, NC, NJ, and TN; 4 trials), 3 (FL ; 2 trials), 5 (ON; 2 trials), 5A (WI ; 1 trial), 5B (QC; 2 trials), 10 (CA; 1 trial), and 11 (ID; 1 trial) during the 2006 growing season. Each trial site consisted of one untreated plot and one treated plot. At each trial site, three foliar applications of a 0.83 lb/gal EC formulation of novaluron (Rimon ® 0.83EC; EPA Reg. No. 66222 - 35) were made to bean plants at 0.076 - 0.088 lb ai/A per application, with 6 - to 8 - day RTI s, for a total rate of 0.2 36 - 0.263 lb ai/A. All applications were made as broadcast applications with the following exceptions: at the CA19 trial, all three applications were made as foliar- directed applications; and at both FL trials, the first application was made as a foliardirected application. Applications were made using ground equipment in 31 - 47 GPA spray volumes, without an adjuvant. Samples of snap bean commodities were harvested at commercial maturity, 2 - 3 days after the last application of novaluron. At the NC04 tri al, additional samples were collected 1, 8, and 9 days after the last application to evaluate residue decline. Samples of snap bean, consisting of pods with seed, were collected at all of the trials. In addition, the protocol required the collection of “ foliage” samples, consisting of the entire, above - ground portion of the bean plant. This requirement was misunderstood at numerous trial locations. In seven of the trials (MD04, NC04, NS04, ON06, ON07, QC03, and QC04), foliage samples consisted of the entire above - ground portion of the plant, exclusive of the pods. In 6 of the trials, (CA19, FL11, FL12, ID04, NJ04, and WI 04), foliage samples consisted of the entire above - ground portion of the plant, but there is no indication as to whether or not the pod s were removed. In the remaining trial (TN04), the foliage sample consisted of leaves onl y. The results (see Table 16 ) indicate that following foliar treatments with the 0.83 lb/gal EC formulation at a total seasonal rate of 0.236 - 0.263 lb ai/A with a 2 - to 3 - day PHI , residues of novaluron ranged from <0.05 to 0.46 ppm in/on 28 samples of treated snap bean pods with seeds, and from 3.0 to 18 ppm in/on 28 samples of treated snap bean foliage. Residues of novaluron in/on snap bean foliage from those trials in which the pods were removed were 5.3 - 18 ppm. In the residue decline trial, residues of novaluron in/on samples of snap bean pods with seedsNovaluron Summary of Analytical Chemistry and Residue Data DP#: 364237

Page 20 of 43 remained approximately

the same and residues in/on snap bean foliage decreased slightly from the 1 - day to the 9 - day

PHI. Overall, the residue decline trial indicated that residues generall y stayed the same with increasing PHIs for snap bean pods with seeds and snap bean foliage without pods. TABLE 16 . Summ ary of Residue Data fromCrop Field Trials with Novalu ron (Snap Beans) . Commodity Total Applic. Rate (lb ai/A) [g ai/ha] PHI

(days) Residue Levels 1 (ppm) n Min. Max. HAFT 2 Median Mean Std. Dev. Snap bean pods with seeds 0.236 - 0.263 [264.4 - 295.2] 2 - 3 28 <0.05 0.46 0.43 0.16 0.18 0.11 Snap bean foliage 3 0.238 - 0.245 [266.8 - 274.6] 2 - 3 12 3.0 10 9.7 5.9 6.3 2.3 Snap bean foliage (entire above - ground portion of plants without pods) 4 0.236 - 0.263 [264.4 - 295.2] 2 - 3 14 5.3 18 17 7.8 9.1 3.8 Foliage, only leaves 5 0.240 [269.0] 3 2 8.1 10 9.1 9.1 9.1 1.3 All S nap bean foliage 6 0.236 - 0.263 [264.4 - 295.2] 2 - 3 28 3.0 18 17 7.6 7.9 3.4 1 For calculation of the median, mean, and standard deviation, the LLMV (0.05 ppm) was used for residues reported as below the calculated LLMV. 2 HAFT = highest - average field trial. 3 The study does not indicate whether or not the pods with seeds were removed from these samples (CA19; FL11; Fl12; ID04; NJ04; and WI04). 4 Snap bean foliage residue data from trials MD04, NC04, NS04, ON06, ON07, QC03, and QC04 where the above - ground portion of the plant excluding the pods was analyzed. 5 The TN04 trial analyzed the leaves only. 6 All snap bean foliage data, including data from trials where the study did not indicate whether or not the pods with seeds were removed, data from trials that analyzed the above - ground portion of the plant excluding the pods, and data from trial that only analyzed the leaves collected off the bean plants. Conclusions: The number and locations of field trials are in accordance with OPPTS Guideline 860.1500 fo r snap bean. The field trial data reflect the proposed use rate but does not reflect the proposed 1 - day PHI. The field trial PHIs for snap beans was 2 - 3 days; however given that the residue decline trial indicated that residues generally stayed the same with increasing PHIs for snap bean pods with seeds and snap bean foliage without pods, the 2 - 3 day PHIdata is acceptable for this petition. The field trial data for snap beans were entered into the Agency ’s tolerance spreadsheet as specified b y the Gu idance for Setting Pesticide Tolerances Based on Field Trial Data SOP to determine appropriate tolerance levels; see Appendix I . The available data support the proposed tolerance (0.60 ppm) for residues of novaluron in/on snap beans. Dry Bean DER Refere nce: 4770580 7 .der.doc Thirteen dry

bean trials were conducted in the U.S. in NAFTA Growing Zones 1 (NY; 1 trial), 5 (MI, OH, SD, and WI; 5 trials), 7 (ND; 2 trials), 8 (CO; 1 trial), 9 (CO; 1 trial) 10 (CA; 1 trial), and 11 (ID and WA; 1 trial each) during the 2007 growing season. Each trial site consisted of one untreated plot and one treated plot. At each trial site, three broadcast spray applications of a 0.83 lb/gal EC formulation (Rimon ® 0.83EC; EPA Reg. No. 66222 - 35) of novaluron were madeNovaluron Summary of Analytical Chemistry and Residue Data DP#: 364237

Page 21 of 43 to bean plants at 0.078 - 0.090 lb ai/A per application, with 6 - to 11 - day RTIs, for a total rate of 0.237 - 0.249 lb ai/A. At the NY08 trial, foliar - directed applications were made instead of broadcast applications. In addition, at the OH13 trial, five broadcast a pplications were made, at 0.080 - 0.081 lb ai/A per application, for a total rate of 0.402 lb ai/A, because the beans had not matured sufficiently

after three applications. Applications were made using ground equipment in 10 - 45 GPA spray

volumes, without an adjuvant. Samples were harvested one day after the last application of novaluron except for the ND09 trial where samples were collected two days after the last application. At 11 of the field sites, whole bean plants or bean pods were allowed to dry in the field and/or a greenhouse for up to 22 day s before collection of dry

bean seed. No drying was needed at two of the field sites (ND08 and WI22) and samples of dry bean seed were collected directly from the plants. The results (see Table 17 ) indicate that following foliar treatments with the 0.83 lb/gal EC formulation at a total seasonal rate of 0.237 - 0.402 lb ai/A (266 - 451 g ai/ha) with a 1 - day PHI ( 2 - day PHIfor 2 bean samples), residues of novaluron ranged from <0.05 to 0.36 ppm in/on 26 samples of treated dry

bean seed. Residues were below the LLMV in/on 21 of the 26 samples. The maximum residue (0.36 ppm) occurred at the ND09 trial where samples were collected at a 2 - day PHI. Residues in/on samples from the one trial where directed applications were made were comparable to those in/on samples treated with broadcast applications. Residues in/on samples from the OH13 trial where five broadcast applications were made were <0.05 and were comparable to other residues. No residue decline data were generated for dry bean seed. A residue decline study with snap beans was submitted separatel y (MRID 47705806). In that study , residues of novaluron in/on samples of snap bean remained approximately the same from a 1 - day

to a 9 - day

PHI. TABLE 17 . Su mmary of Residue Data fromCrop Field Trials with Novaluron (Dry Bean) . Commodity Total Applic. Rate

(lb ai/A) [g ai/ha] PHI

(days) Residue Levels (ppm) 1

n Min. Max. HAFT 2 Median Mean Std. Dev. Dry bean 0.237 - 0.249; 0.402

[266 - 279; 451] 1; 2 3 26 <0 .05 0.36 0.22 0.05 0.065 0.061 1 For calculation of the HAFT, median, mean, and standard deviation, the LLMV (0.05 ppm) was used for residues reported below the LLMV. 2 HAFT = highest - average field trial. 3 At one site (Minot, ND trial), samples were harv ested 2 days after last application. The maximum residue (0.36 ppm) was obtained from this trial. Conclusions: The number and locations of the field trials are in accordance with OPPTS Guideline 860.1500 for dry beans. The field trial data reflect the proposed use rate and PHI for dry beans. The field trial data for dry beans were entered into the Agency ’s MLE spreadsheet and then the Agency ’s MRL tolerance spreadsheet as specified by the Guidance for Setting Pesticide Tolerances Based on Field Trial D ata SOP to determine appropriate tolerance levels; see Appendix I . The available data support a tolerance of 0.30 ppm for residues of novaluron in/on dry bean seed.Novaluron Summary of Analytical Chemistry and Residue Data DP#: 364237

Page 22 of 43 Swiss Chard DER Reference: 4770580 8 .der.doc Three Swiss chard trials were conducted in the U.S. in NAFTA Growing Zones 6 (TX; 1 trial) and 10 (CA; 2 trials) during the 2007 growing season. Each trial site consisted of one untreated plot and one treated plot. At each trial site, three foliar broadcast or foliar - directed spray applications of a 0.83 lb/gal EC formulation of novaluron (Rimon ® 0.83EC; EPA Reg. No. 66222 - 35) were made to Swiss chard plants at 0.079 - 0.082 lb ai/A per application, with 6 - to 8 - day RTIs, for a total rate of 0.237 - 0.243 lb ai/A . Applications were made using groun d equipment in 22 - 58 GPA spray volumes, without an adjuvant. Samples were harvested at commercial maturity, one day after the last application of novaluron. The results (see Table 18 ) indicate that following foliar treatments with the 0.83 lb/gal EC fo rmulation at a total seasonal rate of 0.237 - 0.243 lb ai/A (266 - 272 g ai/ha) with a 1 - day PHI, residues of novaluron ranged 2.2 - 6.6 ppm in/on 6 samples of treated Swiss chard. Residues in/on samples treated with foliar- directed applications were higher (6. 4 and 6.6 ppm) than residues in/on samples treated with broadcast applications (2.2 - 4.0 ppm). No residue decline data were generated for Swiss chard. TABLE 18 . Summ ary of Residue Data fromCrop Field Trials with Novaluron (Swiss Chard) . Commodity T otal Applic. Rate

(lb ai/A) [g ai/ha] PHI

(days) Residue Levels (ppm) n Min. Max. HAFT 1 Median Mean Std. Dev. Swiss chard plant 0.237 - 0.243 [266 - 272] 1 6 2.2 6.6 6.5 3.8 4.2 1.9 1 HAFT = highest - average field trial. Conclusions: The number and locations of field trials are in accordance with OPPTS Guideline 860.1500 for Swiss chard. The field trial data reflect the proposed use rate and PHI for Swiss chard. The field trial data for Swiss chard were entered into the Agency ’s tolerance spreadsheet as specified b y the Guidance for Setting Pesticide Tolerances Based on Field Trial Data SOP to determine appropriate tolerance levels; see Appendix I . The available data support the proposed tolerance (12 ppm) for residues of novaluron in/on Swiss chard. 860.1520 Processed Food and Feed HED does not require residue data for any processed commodities associated with the proposed crops . Therefore, data requirements for processed fo od and feed are not relevant to these commodities 8 60.1650 Submittal of Analytical Reference Standards Analy tical reference standards for novaluron are currentl y available at the EPA National Pesticide Standards Repository and will expire on 22 -NOV - 2010 (personal communication with Theresa Cole, 25 - JUN - 20 09 ).Novaluron Summary of Analytical Chemistry and Residue Data DP#: 364237

Page 23 of 43 860.1850 and 860.1900 Confined and Field Accumulation in Rotational Crops The commodities associated with the current petitions may be rotated. The available confined rotational crop study is adequate. The HED MARC has determined that for tolerance assessment and risk assessment, parent only is the residue of concern (Memo, G. Kramer et al. , 03 - FEB 2004; D297646). Based on the results of the confined rotational crop study, the appropriate PBI for all non - labeled crops is 30 day s (Memo, G. Kramer, 22 - MAR - 2004; D 285474) . The current and proposed labels include a restriction that only registered crops may

be rotated to a treated field within 30 days of the final application. A previously

submitted field rotational crop study was considered inco mplete because certain rotational crop commodities (turnip tops and wheat forage, hay , and grain) were not anal yz ed or included in the study and crops were planted at only one location (Memo, G. Kramer, 07 - FEB 08; DP# 379033) . Although incomplete , the dat a did demonstrate that it is unlikely that residues of novaluron would accumulate at ≥0.05 ppm (LOQ) in/on rotated turnip roots and wheat straw planted ~ 30 , 60, or 90 days following treatment of primary crops at 0.9 - 1 X the maximum seasonal rate. No additional field rotational crop data will be required as the current and proposed labels include a restriction that only registered crops may

be rotated to a treated field within 30 days of the final application. 860.1550 Proposed Tolerances HED has determined that the residue of concern in plants for tolerance enforcement is n ovaluron only . The proposed tolerance expression for petition number 9E7546 is written in terms of “tolerances for combined residues of the insecticide novaluron, 1 - [3 - chloro - 4(1,1,2 - trifluoro - 2 - trifluoro - methoxyethox y) phenyl] - 3 - (2,6 - difluorobenzoyl)urea . ” A revised Section F should be submitted to remove the word combined and cite the appropriate CAS name for novaluron:

“ Tolerances are established for residues of the insecticide novaluron , including its metabolites and degradates, in or on the commoditi es in the table below. Compliance with the tolerance levels specified below is to be determined b y measuring onl y novaluron ( N - [[[3 - chloro - 4 - [1,1,2 - trifluoro - 2 - (trifluoromethoxy )ethoxy]phenyl]amino]carbonyl] - 2,6 - difluorobenzamide ) in or on the following r aw agricultural commodities:” A summary

of the recommended tolerances for the current petition are listed in Table 20 . A revised S ection F is requested which reflect s the recommended tolerances and commodity definitions presented in Table 20 . HED notes that cocona, African eggplant, pea eggplant, scarlet eggplant, goji berry , garden huckleberry , marty nia, naranjilla, okra, roselle, sunberry , bush tomato, currant tomato, and tree tomato residue data have not been submitted and concludes that the fruiting vegetable crop group 8 tolerance (1.0 ppm) may be translated to the proposed commodities (see Reviewer's Guide and Summary of HED ChemSAC Approvals for Amending Commodity

Definitions (40 CFR 180.1(h)) and Crop Group/Subgroups (40 CFR 180.41)). No Codex, Canadian , or Mexican MRL s have been established for novaluron in/on the proposed commodities . Canada is currentl y in the process of reviewing the use of novaluron on strawberries, snap beans, and bell and non - bell peppers. EPA and PMRA tolerance recommendations have been harmonized at 0.45 ppm for low - growing berry subgroup 13 - 07G and 0.60 for edible -podded snap beans. The PMRA has not received petitions for the use of novaluron on fruiting vegetable group 8 and will be setting tolerances for bell and non - bellNovaluron Summary of Analytical Chemistry and Residue Data DP#: 364237

Page 24 of 43 peppers at 0.80 ppm and 0.90 ppm, respectivel y (personal communication with Melissa W atchorn of PMRA, 30 -NOV - 2009). The Agency ’s Guidance for Setting Pesticide Tolerances Based on Field Trial Data was utilized for determining appropriate tolerance levels; see Appendix I for tolerance calculations. Notes to RD: The currently established tomato tolerance and the time - limited tolerance for strawberry

should be removed from 40 CFR §180.598. Additionally , the pending tolerance for bushberry subgroup 13 - 07B (7.0 ppm) should be amended to “bushberry subgroup 13 - 07B, except lowbush blueberry .” Table 20. Tolerance Summary for Novaluron. Commodity Proposed Tolerance (ppm) HED Recommended

Tolerance (ppm) Comments;

Correct Commodity Definition Vegetabl e, fruiting, group 8 1.1 1.0 Vegetable, cucurbit, group 9 0.25 0.15 Berry , low

growing, subgroup 13 - 07G 0.50 0.45 Berry , low - growing, subgroup 13 - 07G Cocona 1.1 1.0 Eggplant, African 1.1 1.0 Eggplant, pea 1.1 1.0 Eggplant, scarlet 1.1 1.0 Goji berry 1.1 1.0 Huckleberry, garden 1.1 1.0 Martynia 1.1 1.0 Naranjilla 1.1 1.0 Okra 1.1 1.0 Roselle 1.1 1.0 Sunberry 1.1 1.0 Tomato, bush 1.1 1.0 Tomato, currant 1.1 1.0 Tomato, tree 1.1 1.0 Bean, snap, succulent 0.60 0.60 Bean, dry 0.20 0.30 Bean, dry, seed Swiss chard 12 12 References MARC Decision Memo, DP# 297646, 2/3/04, G.F. Kramer DP#: 307595 Subject: PP#2F6430. Memo to FDA for Inclusion of the Nov aluron Anal ytical Methods in

PAM Vol II as a Letter Method. From: S. L evy To: M. Wirtz (FDA) Date: 09/15/04Novaluron Summary of Analytical Chemistry and Residue Data DP#: 364237

Page 25 of 43 DP# s : 285474, 287627, 297094, 297228 & 298477 Subject: PP#2F06430. Novaluron. Petition for the Establishment of Permanent

Tolerances for Use on Cotton, Pome Fruits, and Potato. Summary of Analy tical Chemistry

and Residue Data. From: G. Kramer Date: 3/22/04 DP#: 306998 Subject: PP#2F6430. Novaluron in/on Cotton, Pome Fruit, and Potato. Results of the

Petition Method Validation (PMV) of the Proposed Analy tical Enforcement Methods for Plant and Livestock Raw Agricultural Commodities (RACs). From: S. L evy Date: 09/15/04 DP#: 315890 Subject: PP#2F06430. Novaluron on Cotton, Pome Fruits, and Potato. Review of

Amendment Dated 9/28/04 Submitted in Response to HED’s Memo of 3/22/04. Submission of Additional Information for the Dairy Cattle Feeding Study . From: G. Kramer Date: 5/10/05 MRIDs: 46374101 DP# s : 322978 & 315780 Subject: Novaluron. Petitions for the Establishment of Permanent Tolerance s for Use on

Brassica , head and stem, subgroup 5A (PP#4E6834) and Label Amendment for New Use on Pome Fruit (PP#2F6430). Summary of Anal ytical Chemistry

and Residue Data. From: S. L evy Date: 11/3/05 DP#: 325183 Subject: PP#4E6834. Novaluron on Brassica , Head and Stem, Subgroup 5A. Review of

Amendment Dated 15 - Dec - 2005 Submitted in Response to HED’s Memo of 03 - NOV - 2005. Submission of Additional Plant and Livestock Radiovalidation Data. From: S. L evy Date: 08/23/06 DP# s : 340137 & 342004 Subject: Novaluron. Petition for the Establishment of Permanent Tolerances for New Uses

on Sugarcane and Tomato (PP#7E7199); and Request for Amended Use Pattern on Head and Stem Brassica Vegetables. Summary of Anal ytical Chemistry

and Residue Data. From: G. Kramer Dat e: 02/07/08Novaluron Summary of Analytical Chemistry and Residue Data DP#: 364237

Page 26 of 43 Attachments: International Residue Limit Status sheet Appendix I - Tolerance - Assessment Calculations cc : Julie L . Van Alstine (RAB1) RDI: G. Kramer ( 03 -NOV - 09 ), RAB1 Chemists ( 04 -NOV - 09) J. L.Van Alstine : S10 954 :PY - S :( 703 ) 603 - 8866 :7509P:RAB1 Template Version September 2005Novaluron Summary of Analytical Chemistry and Residue Data DP#: 364237

Page 27 of 43 

## INTERNATIONAL RESIDUE LIMIT STATUS Chemical Name: N - [[[3 - chloro - 4 - [1,1,2 - trifluoro - 2 - (trifluoromethoxy)ethoxy] phenyl]amino]carbonyl] - 2,6 - difluorobenzamide Common Name: Novaluron X Proposed tol erance  Reevaluated tolerance  Other Date: 09/18/09

Codex Status (Maximum Residue Limits) U. S. Tolerances  No Codex proposal step 6 or above  No Codex proposal step 6 or above for the crops requested Petition Numbers: 9E7546 DP#: D364237 Other Id entifier: Decision Numbers: PC Code: 124002; Decision Number: 407555 Residue definition (step 8/CXL): novaluron (fat soluble) Revie wer/Branch: J. Van Alstine/RAB1 Residue definition: Novaluron only Crop (s) MRL (mg/kg) Crop(s) Tolerance (ppm) To mato 0.02 (*) Vegetable, fruiting, group 8 1.1 Vegetable, cucurbit, group 9 0.25 Berry, low - growing , subgroup 13 - 07G 0.5 Cocona 1.1 Eggplant, African 1.1 Eggplant, pea 1.1 Eggplant, scarlet 1.1 Goji berry 1.1 Huckleberry, garden 1.1 Martynia 1.1 Naranjilla 1.1 Okra 1.1 Roselle 1.1 Sunberry 1.1 Tomato, bush 1.1 Tomato, currant 1.1 Tomato, tree 1.1 Bean, snap, succulent 0.60 Bean, dry 0.2 0 Swiss chard 12 Limits for Canada Limits for Mexico  No Limits  No Limits for the crops requested  No Limits √ No Limits for the crops requested Residue definition: N - [[[3 - chloro - 4 - [1,1,2 - trifluoro - 2 - (trifluoromethoxy) ethoxy]phenyl]amino]carbonyl] - 2,6 - difluorobenzamide Residue definition: novaluron Crop(s) M RL (mg/kg) Crop(s) MRL (mg/kg)Novaluron Summary of Analytical Chemistry and Residue Data DP#: 364237

Page 28 of 43 Notes/Special Instructions: S.Funk, 10/16/2009. * = absent at or about the limit of quantitation.Novaluron Summary of Analytical Chemistry and Residue Data DP#: 364237

Page 29 of 43 Appendix I. Tolerance - Assessment Calculations. Bell and Non -Bell Peppers ( Fruiting Vegetables C

rop Group 8

) The dataset used to establish a tolerance for novaluron in/on fruiting vegetable group 8 consisted of field trial data for the representative crop s , tomatoes (previousl y submitted ; Memo, G. Kramer, 7 - FEB - 2008; D379033 ) and bell and non - bell peppers (current petition). The bell pepper field trial data represent ed application rates of 0.234 - 0.244 lb ai/A (3 applications at 0.077 - 0.084 lb ai/A per application) with a 1 - to 2 - day PHI. The non - bell pepper field trial data represent ed application r ates of 0.2 40 - 0.245 lb ai/A (3 applications at 0.080 - 0.082 lb ai/A per application) with a 1 - day

PHI . As specified b y the Guidance for Setting Pesticide Tolerances Based on Field Trial Data (SOP), the field trial application rates and PHIs are within 25% of the maximum label application rate and minimum label PHI , respectively . The residue values that were entered into the tolerance spreadsheet are provided in Table s I.1 and I. 2 . As 3 of the 18 bell pepper field trial sample results and 4 of the 8 non - be ll pepper field trial sample results were below the LLMV of 0.05 ppm, MLE procedures were needed to impute censored values . The novaluron bell and non - bell pepper datasets were entered into the tolerance spreadsheet as specified b y the Guidance for Setting Pesticide Tolerances Based on Field Trial Data SOP . Visual inspection of the lognormal probability plot s (Figure s I.1 ; I.3 ) and the results from the approximate Shapiro - Francia test statistic s (Figure s I. 2 ; I.4 ) indicated that the dataset s w ere reason abl y lognormal. Since the field trial data for novaluron in/on bell pepper represent a large dataset (i.e., more than 15 samples) and are reasonably lognormal, the minimum of the 95% upper - confidence limit (UCL) on the 95 th percentile and the point estimate of the 99 th percentile should be selected as the tolerance value. Using the rounding procedure as outlined in the SOP, the 95% UCL on the 95 th percentile rounds to the value 0.80 ppm and the point estimate of the 99 th percentile rounds to the value 0.8 0 ppm for bell peppers (Figure I.2). Since the field trial data for novaluron in/on non - bell peppers represent a small dataset (i.e., less than 15 samples) and are reasonabl y lognormal, the minimum of the 95% UCL on the 95 th percentile and the point estim ate of the 99 th percentile should be selected as the tolerance value. Using the rounding procedure as outlined in the SOP, the median 95 th UCLrounds to 0.90 ppm for non - bell peppers . Since a dataset on tomatoes was previously submitted ( Memo, G. Kramer, 7 - FEB - 2008; D379033 ) and the recommended bell and non - bell pepper tolerances are below the tomato tolerance (1.0 ppm), the recommended tolerance for fruiting vegetable group 8 is 1.0 ppm. Table I. 1 . Residue D ata Used to Calculate T olerance for N ov aluron

in/on Bell Peppers . Regulator: EPA Chemical: Novaluron (0.83 EC Form ulation) Crop: Peppers(Bell) PHI: 1 - 2 Days App. Rate: 0.234 - 0.244 lb ai/A Submitter: IR- 4 MRID Citation: 47705801 Residues of Novaluron (ppm)Novaluron Summary of Analytical Chemistry and Residue Data DP#: 364237

Page 30 of 43 Table I. 1 . Residue D ata Used to Calculate T olerance for N ov aluron

in/on Bell Peppers . 0.05 0.05 0.13 0.14 0.07 0.07 0.28 0.29 0.07 0.07 0.21 0.22 MLE 0.031243757 MLE 0.036140742 MLE 0.040824722 0.05 0.36 0.37 Figure I. 1 . Lognorm al Probability Plot of Novaluron Field Trial Data for Bell Peppers .

Lognormal Probability Plot

99.9 99 98 95 90 80 70 50 30 20 10 5 2 1 0.1 1.0000

0.5000

0.2500

0.1250

0.0625

0.0313

0.0156 y = 0.8426x - 2.2898 R 2 = 0.9249

PercentilesConcentrations EPA Novaluron (0.83 EC Formulation) FROM MLE Calculator Peppers(Bell) 1-2 Days 0.234- 0.244 lb ai/A IR-4Novaluron Summary of Analytical Chemistry and Residue Data DP#: 364237

Page 31 of 43 Figure I . 2 . Tolerance Spreadsheet Summary of Novaluron Field Trial Data for Bell Peppers .

Table I. 2 . Residue Data Used to Calculate Tolerance for Novaluron

in/on Non - Bell Peppers . Regulator: EPA Chemical: Novaluron (0.83 EC Formulation) Crop: Non - Bell Pepper PHI: 1 - 2 Days App. Rate: 0.240 - 0.245 lb ai/A Submitter: IR- 4 MRID Citation: 47705801 Residues of Novaluron (ppm) 0.34 0.36 MLE 0.007759286 MLE 0.01495195 MLE 0.023795016 MLE 0.035102208 0.2 0.2 Regulator: EPA Chemical: Novaluron (0.83 EC Formulation) FROM MLE Calculator Crop: Peppers(Bell) PHI: 1-2 Days App. Rate: 0.234-0.244 lb ai/A Submitter: IR-4

n: 18 min: 0.03 max: 0.37 median: 0.07 average: 0.14 95th Percentile 99th Percentile 99.9th Percentile 0.35 0.45 0.60 (0.45) (0.60) (--) 0.45 0.80 1.4 (0.80) (1.8) (--) 0.50 0.50 0.40 0.9249 p-value > 0.05 : Do not reject lognormality assumption Approximate Shapiro-Francia Normality Test EU Method I Normal

UCLMedian95th 95/99 Rule EU Method II Distribution-Free Mean+3SDNovaluron Summary of Analytical Chemistry and Residue Data DP#: 364237

Page 32 of 43 Figure I. 3 . Lognorm al Probability Plot of Novaluron Field Trial Data for Non - Bell Peppers .

Figure I. 4 . Tolerance Spreadsheet Summary of Novaluron Field Trial Data for Non - Bell Peppers .

Cucumber, Cantalo upe, and Summer Squash (Cucurbit Vegetables Crop Group 9) The dataset used to establish a tolerance for novaluron in/on cucurbit v egetables crop group 9 consisted of field trial data for the representative crop s , cucumber, muskmelon, and summer squash , rep resenting application rates of 0.230 - 0.249 lb ai/A (3 applications at 0.075 - 0.085 lb ai/A per application) with a 1 - day PHI. As specified by

the Guidance for Setting Pesticide Tolerances Based on Field Trial Data (SOP), the field trial application rates a nd PHI s are within 25% of the maximum label application rate and minimum label PHI , respectively . The residue values that were entered into the tolerance spreadsheet for cantaloupe and summer squash are provided in Table s I. 3 and I. 4 . All cucumber sample s had residues below the LLMV (0.05 ppm), so the tolerance spreadsheet was not used and the recommended cucumber tolerance was 0.05 ppm. As 10 of the 16 cantaloupe field trial sample results and 11 of the 14 summer squash field trial sample results were below the LLMV of 0.05 ppm, MLE procedures were needed to impute censored values . The cantaloupe and summer squash datasets were entered into the tolerance spreadsheet as specified b y the Guidance for Setting Pesticide Tolerances Based on Field Trial D ata SOP . Regulator: EPA Chemical: Novaluron (0.83 EC Formulation)From MLE Calculator Crop: Non-Bell Pepper PHI: 1-2 Days App. Rate: 0.240-0.245 lb ai/A Submitter: IR-4

n: 8 min: 0.01 max: 0.36 median: 0.12 average: 0.15 95th Percentile 99th Percentile 99.9th Percentile 0.40 0.50 0.70 (0.70) (0.80) (--) 0.90 2.5 8.0 (9.0) (55) (--) 0.70 0.60 0.90 0.9050 p-value > 0.05 : Do not reject lognormality assumption Approximate Shapiro-Francia Normality Test EU Method I Normal

UCLMedian95th 95/99 Rule EU Method II Distribution-Free Mean+3SD Lognormal Probability Plot

99.9 99 98 95 90 80 70 50 30 20 10 5 2 1 0.1 1.0000 0.5000 0.2500 0.1250 0.0625 0.0313 0.0156 0.0078 0.0039 y = 1.5573x - 2.6836 R 2 = 0.905

PercentilesConcentrations EPA Novaluron (0.83 EC Formulation)From MLE Calculator Non-Bell Pepper 1-2 Days 0.240- 0.245 lb ai/A IR-4Novaluron Summary of Analytical Chemistry and Residue Data DP#: 364237

Page 33 of 43 Visual inspection of the lognormal probability plot s (Figure s I.5; I.7 ) and the results from the approximate Shapiro - Francia test statistic s (Figure s I .6; I.8 ) indicated that the dataset s w ere reasonabl y lognormal . Since the field trial data for novaluron in/on cantaloupe represent a large dataset (i.e., more than 15 samples) and are reasonably lognormal, the minimum of the 95% UCL on the 95 th percentile and the point estimate of the 99 th percentile should be selected as the tolerance value. Using the rounding procedure as outlined in the SOP, the 95% UCLon the 95 th percentile rounds to the value 0.15 ppm and the point estimate of the 99 th percentile rounds to the value 0.15 ppm (Figure I. 6 ). Since the field trial data for novaluron on summer s quash represent a small dataset (i.e., less than 15 samples) and are reasonabl y lognormal, the minimum of the 95% UCLon the 95 th percentile and the point estimate of the 99 th percentile should be selected as the tolerance value. Using the rounding proced ure as outlined in the SOP, the 95% UCLon the 95 th percentile rounds to the value 0.10 ppm and the point estimate of the 99 th percentile rounds to the value 0.09 ppm (Figure I. 8). The recommended tolerance for cucurbit v egetables crop group 9 is 0.15 ppm , based on the cantaloupe field trial since it is the highest tolerance for the crop group. Table I. 3 . Residue Data Used to Calculate Tolerance for Novaluron

in/on Cantaloupe . Regulator: EPA Chemical: Novaluron (0.83 EC Formulation) Crop: Cantaloupe PHI: 1 Day App. Rate: 0.239 - 0.245 lb ai/A Submitter: IR- 4 MRID Citation: 47705803 Residues of Novaluron (ppm) MLE 0.020 MLE 0.024 0.051 MLE 0.027 0.046 MLE 0.030 MLE 0.033 MLE 0.035 0.093 0.090 0.081 MLE 0.038 MLE 0.041 0.070 MLE 0.043 MLE 0.047Novaluron Summary of Analytical Chemistry and Residue Data DP#: 364237

Page 34 of 43 Figure I. 5 . Lognorm al Probability Plot of Novaluron Field Trial Data for Cantaloupe .

Figure I. 6 . Tolerance Spreadsheet Summary of Novaluron Field Trial Data for Cantaloupe .

Table I. 4 . Residue Data Used to Calculate Tolerance for Novaluron

in/on Summer Squash . Regulator: EPA Chemical: Novaluron (0.83 EC Formulation) USING MLE Crop: Summer Squash PHI: 1 Day App. Rate: 0.240 - 0.249 lb ai/A Submitter: IR- 4 MRID Citation: 47705804 Residues of Novaluron (ppm) MLE 0.021 MLE 0.024 MLE 0.027 MLE 0.029 MLE 0.031 MLE 0.033 MLE 0.035 MLE 0.038 0.074 Regulator: EPA Chemical: Novaluron (0.83 EC Formulation)USING MLE Crop: Cantaloupe PHI: 1 Day App. Rate: 0.239-0.245 lb ai/A Submitter: IR-4

n: 16 min: 0.02 max: 0.09 median: 0.04 average: 0.05 95th Percentile 99th Percentile 99.9th Percentile 0.09 0.15 0.15 (0.15) (0.15) (--) 0.10 0.15 0.20 (0.15) (0.25) (--) 0.15 0.15 0.25 0.9705 p-value > 0.05 : Do not reject lognormality assumption Approximate Shapiro-Francia Normality Test EU Method I Normal

UCLMedian95th 95/99 Rule EU Method II Distribution-Free Mean+3SD Lognormal Probability Plot

99.9 99 98 95 90 80 70 50 30 20 10 5 2 1 0.1 1.0000

0.5000

0.2500

0.1250

0.0625

0.0313

0.0156 y = 0.478x - 3.1413 R 2 = 0.9705

PercentilesConcentrations EPA Novaluron (0.83 EC Formulation)USING MLE Cantaloupe 1 Day 0.239-0.245 lb ai/A IR-4Novaluron Summary of Analytical Chemistry and Residue Data DP#: 364237

Page 35 of 43 Table I. 4 . Residue Data Used to Calculate Tolerance for Novaluron

in/on Summer Squash . 0.067 0.045 MLE 0.040 MLE 0.043 MLE 0.046 Figure I. 7 . Lognorm al Probability Plot of Novaluron Field Trial Data for Summer Squash .

Figure I. 8 . Tolerance Spreadsheet Summary of Novaluron Field Trial Data for Summer Squash .

Strawberry (

Low-growing B erry Crop Subgroup 13 - 07G ) The dataset used to establish a tolerance for novaluron in/on low - growing b erry c rop s ubgroup 13 - 07G consisted of field trial data for the representative crop, strawberry , representing application rates of 0.238 - 0.251 lb ai/A (3 applications at 0. 077 - 0.084 lb ai/A per application) with a 1 - day

PHI. As specified b y the Guidance for Setting Pesticide Tolerances Based on Field Trial Data (SOP), the field trial application rates and PHI s are within 25% of the maximum label application rate and minimum label PHI , respectively . The residue v alues that were entered into the tolerance spreadsheet are provided in Table I. 5 . The novaluron strawberry dataset was entered into the tolerance spreadsheet as specified by the Guidance for Setting Pesticide Tolerances Based on Field Trial Data SOP . All 20 field trial sample results were above the LLMV ( 0.05 ppm). Visual inspection of the lognor mal probability

plot (Figure I.9 ) and the results from the approximate Shapiro - Francia test statistic

Lognormal Probability Plot

99.9 99 98 95 90 80 70 50 30 20 10 5 2 1 0.1 1.0000

0.5000

0.2500

0.1250

0.0625

0.0313

0.0156 y = 0.3746x - 3.2952 R 2 = 0.9728

PercentilesConcentrations EPA Novaluron (0.83 EC Formulation) USING MLE Summer Squash 1 Day 0.240-0.249 lb ai/A IR-4

Regulator: EPA Chemical: Novaluron (0.83 EC Formulation) USING MLE Crop: Summer Squash PHI: 1 Day App. Rate: 0.240-0.249 lb ai/A Submitter: IR-4

n: 14 min: 0.02 max: 0.07 median: 0.04 average: 0.04 95th Percentile 99th Percentile 99.9th Percentile 0.07 0.08 0.09 (0.08) (0.10) (--) 0.07 0.09 0.15 (0.10) (0.15) (--) 0.10 0.09 0.25 0.9728 p-value > 0.05 : Do not reject lognormality assumption Approximate Shapiro-Francia Normality Test EU Method I Normal

UCLMedian95th 95/99 Rule EU Method II Distribution-Free Mean+3SDNovaluron Summary of Analytical Chemistry and Residue Data DP#: 364237

Page 36 of 43 (Figure I.10 ) indicated that the dataset was reasonably lognormal. Since the field trial data for novaluron on strawberry represent a large dataset (i.e., more than 15 samples) and are reasonably lognormal, the minimum of the 95% UCL on the 95 th percentile and the point estimate of the 99 th percentile should be s elected as the tolerance value. Using the rounding procedure as outlined in the SOP, the 95% UCLon the 95 th percentile rounds to the value 0.45 ppm and the point estimate of the 99 th percentile rounds to the value 0.45 ppm (Figure I.10 ). Therefore, 0.45 ppm is the recommended tolerance level for novaluron in/on growing b erry c rop s ubgroup 13 - 07G . Table I. 5 . Residue Data Used to Calculate Tolerance for Novaluron

in/on Strawberry . Regulator: EPA Chemical: Novaluron (0.83 EC Formulation) Crop: Straw b erry PHI: 1 Day App. Rate: 0.238 - 0.251 lb ai/A Submitter: IR- 4 MRID Citation: 47705805 Residues of Novaluron (ppm) 0.0500 0.2870 0.0685 0.1140 0.1890 0.2190 0.2380 0.2610 0.0500 0.0682 0.0737 0.1240 0.1180 0.1760 0.0970 0.1070 0.1670 0.1810 0.0948 0.1080Novaluron Summary of Analytical Chemistry and Residue Data DP#: 364237

Page 37 of 43 Figure I. 9 . Lognorm al Probability Plot of Novaluron Field Trial Data for Strawberries .

Figure I. 10 . Tolerance Spreadsheet Summary of Novaluron Field Trial Data for Strawberries .

Snap Bea ns The dataset used to establish a tolerance for novaluron in/on snap beans consisted of field trial data representing application rates of 0.236 - 0.263 lb ai/A (3 applications at 0. 076 - 0.088 lb ai/A per application) with a 2 - to 3 - day PHI . As specified by the Guidance for Setting Pesticide Tolerances Based on Field Trial Data (SOP), the field trial application rates and PHI s are within 25% of the maximum label application rate and minimum label PHI , respectively . The residue values that were entered into the tolerance spreadsheet are provided in Table I. 6 . The novaluron snap bean dataset was entered into the tolerance spreadsheet as specified b y the Guidance for Setting Pesticide Tolerances Based on Field Trial Data SOP . All 28 field trial sample results were above the LLMV ( 0.05 ppm). Visual inspection of the lognormal probability

plot (Figure I. 11 ) and the results from the approximate Shapiro - Francia test statistic (Figure I. 1 2) indicated that the dataset was reasonably lognormal. Since the field trial data for novaluron in/on snap beans represent a large dataset (i.e., more than 15 samples) and are reasonably lognormal, the minimum of the 95% UCL on the 95 th percentile and the point estimate of the 99 th percentile should be selected as the tolerance v alue. Using the rounding procedure as outlined in the SOP, the 95% UCLon the 95 th percentile rounds to the Regulator: EPA Chemical: Novaluron (0.83 EC Formulation) Crop: Strawberry PHI: 1 Day App. Rate: 0.238-0.251 lb ai/A Submitter: IR-4

n: 20 min: 0.05 max: 0.29 median: 0.12 average: 0.14 95th Percentile 99th Percentile 99.9th Percentile 0.30 0.35 0.40 (0.35) (0.40) (--) 0.30 0.45 0.70 (0.45) (0.80) (--) 0.40 0.40 0.70 0.9727 p-value > 0.05 : Do not reject lognormality assumption Approximate Shapiro-Francia Normality Test EU Method I Normal

UCLMedian95th 95/99 Rule EU Method II Distribution-Free Mean+3SD Lognormal Probability Plot

99.9 99 98 95 90 80 70 50 30 20 10 5 2 1 0.1 1.0000

0.5000

0.2500

0.1250

0.0625

0.0313 y = 0.5432x - 2.098 R 2= 0.9727

PercentilesConcentrations EPA Novaluron (0.83 EC Formulation) Strawberry 1 Day 0.238-0.251 lb ai/A IR-4Novaluron Summary of Analytical Chemistry and Residue Data DP#: 364237

Page 38 of 43 value 0.60 ppm and the point estimate of the 99 th percentile rounds to the value 0.60 ppm (Figure I. 1 2). Therefore, 0.60 ppm is the recommended to lerance level for novaluron in/on snap beans . Table I. 6 . Residue Data Used to Calculate Tolerance for Novaluron

in/on Snap Beans . Regulator: EPA Chemical: Novaluron (0.83 EC Formulation) Crop: Snap Bean PHI: 2 - 3 Days App. Rate: 0.236 - 0.263 lb ai/A Submitter: IR- 4 MRID Citation: 47705806 Residues of Novaluron (ppm) 0.400 0.460 0.088 0.160 0.160 0.170 0.160 0.180 0.096 0.120 0.240 0.400 0.310 0.320 0.050 0.050 0.096 0.160 0.094 0.120 0.170 0.180 0.160 0.180 0.140 0.140 0.090 0.100Novaluron Summary of Analytical Chemistry and Residue Data DP#: 364237

Page 39 of 43 Figure I. 11 . Lognorm al Probability Plot of Novaluron Field Trial Data for Snap Beans .

Figure I. 12 . Tolerance Spreadsheet Summary of Novaluron Field Trial Data for Snap Beans .

Swiss Chard The dataset used to establish a tolerance for novaluron in/on Swiss chard consisted of field trial data representing application rates of 0.237 - 0.243 lb ai/A (3 applications at 0. 079 - 0.082 lb ai/A per application) with a 1 - day PHI . As specified by

the Guidance for Setting Pesticide Tolerances Based on Field Trial Data (SOP), the field trial application rates and PHI s are within 25% of the maximum label application rate and minimum label PHI , respectively . The residue values that were entered into the tolerance spreadsheet are provided in Table I. 7 . The novaluron Swiss chard dataset was entered into the tolerance spreadsheet as specified b y the Guidance for Setting Pesticide Tolerances Based on Field Trial Data SOP . All 3 field trial sample results were above the LLMV ( 0.05 ppm). Visual inspection of the lognormal probability

plot (Figure I.1 3 ) and the results from the approximate Shapiro - Francia test statistic (Figure I. 1 4 ) indicated that the dataset was reasonably lognormal. Since the field trial data for novaluron in/on Swiss chard represent a small dataset (i.e., less than 15 samples) and are reasonably lognormal, the minimum of the 95% UCL on the 95 th percentile Lognormal Probability Plot

99.9 99 98 95 90 80 70 50 30 20 10 5 2 1 0.1 1.0000

0.5000

0.2500

0.1250

0.0625

0.0313 y = 0.5646x - 1.8769 R 2 = 0.9562

PercentilesConcentrations EPA Novaluron (0.83 EC Formulation) Snap Bean 2-3 Days 0.236-0.263 lb ai/A IR-4

Regulator: EPA Chemical: Novaluron (0.83 EC Formulation) Crop: Snap Bean PHI: 2-3 Days App. Rate: 0.236-0.263 lb ai/A Submitter: IR-4

n: 28 min: 0.05 max: 0.46 median: 0.16 average: 0.18 95th Percentile 99th Percentile 99.9th Percentile 0.40 0.45 0.60 (0.45) (0.60) (--) 0.40 0.60 0.90 (0.60) (0.90) (--) 0.40 0.50 0.90 0.9562 p-value > 0.05 : Do not reject lognormality assumption Approximate Shapiro-Francia Normality Test EU Method I Normal

UCLMedian95th 95/99 Rule EU Method II Distribution-Free Mean+3SDNovaluron Summary of Analytical Chemistry and Residue Data DP#: 364237

Page 40 of 43 and the point estimate of the 99 th percentile should be selected as the tolerance value. Using the rounding procedure as outlined in the SOP, the 95% UCLon the 95 th percentile rounds to the value 25 ppm and the point estimate of the 99 th percentile rounds to the value 12 ppm (Figure I. 14). Because the 12 -ppm value was the minimum value, 12 ppm is the recommended tolerance level for novaluron in/on Swiss chard . Table I. 7 . Residue Data Used to Calculate Tolerance for Novaluron

in/on Swiss Chard . Regulator: EPA Chemical: Novaluron (0.83 EC Formulatio n) Crop: Swiss Chard PHI: 1 Day App. Rate: 0.237 - 0.243 lb ai/A Submitter: IR- 4 MRID Citation: 47705808 Residues of Novaluron (ppm) 2.200 2.300 6.400 6.600 3.600 4.000 Figure I. 13 . Lognorm al Probability Plot of Novaluron Field Trial D ata for Swiss Chard . Lognormal Probability Plot

99.9 99 98 95 90 80 70 50 30 20 10 5 2 1 0.1 7.0000

3.5000

1.7500 y = 0.4978x + 1.3387 R 2 = 0.9173

PercentilesConcentrations EPA Novaluron (0.83 EC Formulation) Swiss Chard 1 Day 0.237-0.243 lb ai/A IR-4Novaluron Summary of Analytical Chemistry and Residue Data DP#: 364237

Page 41 of 43 Figure I. 14 . Tolerance Spreadsheet Summary of Novaluron Field Trial Data for Swiss Chard .

Dry Beans The dataset used to establish a tolerance for novaluron in/on dry beans consisted of field trial data representing application rates of 0.237 - 0.249 lb ai/A (3 applications at 0. 078 - 0. 090 lb ai/A per application) with a 1 - to 2 - day PHI (onl y 1 trial had a 2 - day PHI) . As specified b y the Guidance for Setting Pesticide Tolerances Based on Field Trial Data (SOP), the field trial application rates and PHIs are within 25% of the maximum label application rate and minimum label PHI, respectivel y. The residue values that were entered into the tolerance spreadsheet are provided in Tab le I. 8 . As 21 of the 26 bell pepper field trial sample results were below the LLMV of 0.05 ppm, MLE procedures were needed to impute censored values . The novaluron dry

bean dataset was entered into the tolerance spreadsheet as specified by the Guidance for Setting Pesticide Tolerances Based on Field Trial Data SOP . Visual inspection of the lognormal probability plot (Figure I. 15 ) and the results from the approximate Shapiro Francia test statistic (Figure s I. 16 ) indicated that the dataset s w ere reasonably lognormal. Since the field trial data for novaluron on dry bean represent a large dataset (i.e., more than 15 samples) and are reasonably lognormal, the minimum of the 95% UCL on the 95 th percentile and the point estimate of the 99 th percentil e should be selected as the tolerance value. Using the rounding procedure as outlined in the SOP, the 95% UCLon the 95 th percentile rounds to the value 0.30 ppm and the point estimate of the 99 th percentile rounds to the value 0.30 ppm (Figure I.16 ). Th erefore, 0.30 ppm is the recommended tolerance level for novaluron in/on dry bean . Table I. 8 . Residue Data Used to Calculate Tolerance for Novaluron

in/on Dry Beans . Regulator: EPA Chemical: Novaluron (0.83 EC Formulation) Crop: Dry Bean PHI: 1 Day (one trial -- 2 day s) App. Rate: 0.237 - 0.249 lb ai/A Submitter: IR- 4 MRID Citation: 47705807 Regulator: EPA Chemical: Novaluron (0.83 EC Formulation) Crop: Swiss Chard PHI: 1 Day App. Rate: 0.237-0.243 lb ai/A Submitter: IR-4

n: 6 min: 2.20 max: 6.60 median: 3.80 average: 4.18 95th Percentile 99th Percentile 99.9th Percentile 8.0 9.0 11 (12) (14) (--) 9.0 12 17 (25) (45) (--) 13 10 30 0.9173 p-value > 0.05 : Do not reject lognormality assumption Approximate Shapiro-Francia Normality Test EU Method I Normal

UCLMedian95th 95/99 Rule EU Method II Distribution-Free Mean+3SDNovaluron Summary of Analytical Chemistry and Residue Data DP#: 364237

Page 42 of 43 Table I. 8 . Residue Data Used to Calculate Tolerance for Novaluron

in/on Dry Beans . Residues of Novaluron (ppm) MLE 0.002 MLE 0.003 MLE 0.004 MLE 0.004 MLE 0.005 MLE 0.006 MLE 0.007 MLE 0.008 MLE 0.010 MLE 0.011 MLE 0.012 MLE 0.014 0.052 0.058 0.360 0.082 MLE 0.015 MLE 0.017 MLE 0.020 MLE 0.022 MLE 0.025 MLE 0.028 MLE 0.032 0.078 MLE 0.037 MLE 0.042 Figure I. 15 . Lognorm al Probability Plot of Novaluron Field Trial Data for Dry Beans .

Figure I. 16 . Tolerance Spreadsheet Summary of Novaluron Field Trial Data for Dry Beans . Lognormal Probability Plot

99.9 99 98 95 90 80 70 50 30 20 10 5 2 1 0.1 1.0000 0.5000 0.2500 0.1250 0.0625 0.0313 0.0156 0.0078 0.0039 0.0020 0.0010 y = 1.2308x - 4.0849 R 2= 0.9848

PercentilesConcentrations EPA Novaluron (0.83 EC Formulation)With MLE Dry Bean 1 Day (one trial--2 days) 0.237- 0.249 lb ai/A IR-4Novaluron Summary of Analytical Chemistry and Residue Data DP#: 364237

Page 43 of 43 Regulator: EPA Chemical: Novaluron (0.83 EC Formulation)With MLE Crop: Dry Bean PHI: 1 Day (one trial--2 days) App. Rate: 0.237-0.249 lb ai/A Submitter: IR-4

n: 26 min: 0.00 max: 0.36 median: 0.02 average: 0.04 95th Percentile 99th Percentile 99.9th Percentile 0.20 0.20 0.30 (0.20) (0.30) (--) 0.15 0.30 0.70 (0.30) (0.80) (--) 0.08 0.25 0.09 0.9848 p-value > 0.05 : Do not reject lognormality assumption Approximate Shapiro-Francia Normality Test EU Method I Normal

UCLMedian95th 95/99 Rule EU Method II Distribution-Free Mean+3SD