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

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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, D.C. 20460

OFFICE OF PREVENTION, PESTICIDES,

AND TOXIC SUBSTANCES

MEMORANDUM

Date: 04-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 Residue 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

TXR 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 Assessment Branch 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 currently 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, leafy 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 emulsifiable 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 insecticide 
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novaluron, 1-[3-chloro-4-(1,1,2-trifluoro-2-trifluoro-methoxyethoxy)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

Martynia........................................................................1.1 ppm

Naranjilla.......................................................................1.1 ppm

Okra...............................................................................1.1 ppm

Roselle...........................................................................1.1 ppm

Sunberry........................................................................1.1 ppm

Tomato, bush.................................................................1.1 ppm

Tomato, currant.............................................................1.1 ppm

Tomato, tree ..................................................................1.1 ppm

Bean, snap, succulent..................................................0.60 ppm

Bean, dry.....................................................................0.20 ppm

Swiss chard ....................................................................12 ppm

The end-use product associated with these registration requests is Rimon

®

0.83 EC Insecticide 

(EPA Reg. No. 66222-35), an EC formulation containing 9.3% ai (equivalent to 0.83 lb ai/gal). 

Rimon

®

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 retreatment intervals (RTIs) 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 PHI is proposed. The label for cucurbits also 

proposes the use of 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 Rimon

®

at a maximum seasonal rate of 0.23 lb ai/A with 14-day RTIs and a 1-day PHI is proposed. For 

the remaining commodities in the low-growing berry subgroup 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 specifies 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 includes a statement which prohibits the use 

of novaluron on crops grown for food in greenhouses, except tomatoes. The revised Section 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. 
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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 

greens (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 byproducts (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 byproducts), 0.03 ppm (poultry meat), and 0.01 ppm (meat and meat 

byproducts of hog). A time-limited tolerance, with an expiration date of 31-DEC-2011, is 

established in association with a Section 18 Emergency Exemption for strawberries at 0.50 ppm. 

The exemption tolerance for strawberries will be superseded by 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 previously concluded that the nature of the residue in livestock is adequately 

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 for 

purposes of tolerance enforcement and risk assessment is novaluron only (Memo, G. Kramer et 

al., 03-FEB-2004; D297646).

The available confined rotational crop study is adequate. The HED Metabolism Assessment 

Review Committee (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 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 analytical methods for the enforcement of residue tolerances. For 

analysis of crop matrices for residues of novaluron, gas chromatography/electron-capture 

detection (GC/ECD) and high-performance liquid chromatography/ultraviolet (HPLC/UV) 

methods are available. These methods have undergone successful validation by the Analytical 

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 Analytical 

Method Volume II (PAM II). 

The GC/ECD enforcement method (with minor modifications) was used for data-collection in 

the analysis of samples collected from the bell and non-bell pepper, cantaloupe, summer squash, 

strawberry, snap bean, dry bean, and Swiss chard field trials. The method was adequately 

validated in conjunction with the studies. Cucumber samples were analyzed using a method 

based on Pyxant Labs Inc. mass spectrometry (MS) method number METH1585-00.00, entitled 

“Determination of Novaluron in Crop Matrices by LC/MS/MS.” The method has not been 
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previously reviewed; however, it is similar to the GC/ECD enforcement method. The method 

was adequately 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, concurrent 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 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 foliage for 8.7 months (264 days), dry

bean seed for 5.0 months (151 days), and Swiss chard for 11.7 months (356 days).

Concurrent storage stability data for cucumbers and non-bell peppers were not generated. 

Current Agency 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 squash, strawberries, snap beans, dry bean seed, and Swiss chard are adequate to support 

the establishment of the requested crop/subgroup tolerances. 

There are no processing studies associated with the current petition. Therefore, a discussion of 

processed commodities is unnecessary. 

The field trial data were entered into the Agency’s maximum residue limits (MRL) tolerance 

spreadsheet to determine appropriate tolerances. The maximum-likelihood estimation (MLE) 

spreadsheet was used for bell peppers, non-bell peppers, cantaloupe, 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-growing, 

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 0.30 ppm for dry bean seed. 
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No Codex, Canadian, or Mexican MRLs have been established for novaluron in/on the proposed 

commodities. Canada is currently 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, respectively (personal communication with Melissa 

Watchorn of PMRA, 30-NOV-2009). 

Regulatory Recommendations 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 table below. Compliance with the tolerance levels specified below is to be 

determined by measuring only novaluron (N-[[[3-chloro-4-[1,1,2-trifluoro-2-

(trifluoromethoxy)ethoxy]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 (D363988).

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 low-growing 

berry subgroup 13-07G is prohibited;

 Corrects “lowbush berry” to “lowbush blueberry” in the low-growing berry subgroup 13-

07G section of the label; and

 States that the use of novaluron on crops grown for food in greenhouses, except tomatoes,

is prohibited. 

860.1550 Proposed Tolerances

 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-
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trifluoro-2-trifluoro-methoxyethoxy)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 determined by measuring only

novaluron (N-[[[3-chloro-4-[1,1,2-trifluoro-2-

(trifluoromethoxy)ethoxy]phenyl]amino]carbonyl]-2,6-difluorobenzamide) in or on 

the following raw agricultural commodities:”

 A revised Section F is requested which reflects the recommended tolerances and 

commodity definitions presented in Table 20. 

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.”

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 Nomenclature.

Chemical structure

O

N

H

N

H

O

F

F

Cl

O

O

CF3

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 products (EPs) Rimon

®

0.83 EC Insecticide (0.83 lb/gal EC; EPA Reg. No. 66222-35)
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Table 2. Physicochemical Properties 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/cm3at 22C

Water solubility 3 μg/L at 20C

Solvent solubility (at 25C)

0.00839 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-2009, for Rimon

®

0.83 EC Insecticide (EPA 

Reg. No. 66222-35) to include the proposed new uses (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, goji berry, garden huckleberry, martynia, naranjilla, okra, roselle, 

sunberry, bush tomato, currant tomato, tree tomato, snap beans, dry bean seed, and Swiss chard. 

Table 3. Summary of Directions for Use of Novaluron.

Application 

Equipment

Formulation

[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, goji 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, bearberry, bilberry, 

lowbush 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.
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Table 3. Summary of Directions for Use of Novaluron.

Application 

Equipment

Formulation

[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 squash, 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 nonionic 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 trees less than 

10 feet tall, and 100 to 400 GPA on trees greater than 10 feet tall. Applications of Rimon

®

0.83 

EC may also be made through sprinkler irrigation systems; use of other types of irrigation 

systems are prohibited. The accepted (master) label for Rimon

®

0.83 EC Insecticide states that 

only registered crops may be rotated in a treated field within 30 days of application. The current 
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and proposed labels include a restriction that only registered crops may be rotated to a treated 

field within 30 days of the final application. Rimon

® 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 beans and Swiss chard. A revised 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, low-growing berry subgroup 13-07G, and 

strawberry is prohibited and includes a statement which prohibits the use of novaluron on crops 

grown for food in greenhouses, except tomatoes. The revised section B should also correct

“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, pea eggplant, scarlet eggplant, goji 

berry, garden huckleberry, martynia, naranjilla, okra, roselle, sunberry, bush tomato, currant 

tomato, tree tomato, snap beans, dry beans, and Swiss chard. A revised 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 subgroup 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 previously (PP#2F6430) concluded that the nature of the residue in plants is adequately 

understood based on acceptable metabolism studies conducted on apples, cabbage, cotton, and 

potatoes using [difluorophenyl-U14C]novaluron and [chlorophenyl-U14C]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 analyzed plant matrices. The reviewed studies also 

indicate novaluron, when foliarly applied during the vegetative growth stage, is not readily 

translocated to mature apple fruit, potato tubers, or cottonseed. The HED MARC (03-FEB2004) 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 previously concluded that the nature of the residue in livestock is adequately 

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 for 
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purposes of tolerance enforcement and risk assessment is novaluron only (Memo, G. Kramer et 

al., 03-FEB-2004; D297646).

860.1340 Residue Analytical 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 322978 & 315780, 11/3/05, S. Levy (PP#4E6834)

Residue Chemistry Memo, DP# 325183, 8/23/06, S. Levy (PP#4E6834; Radiovalidation)

Enforcement Methods: MANA previously submitted under PP#2F6430 a GC/ECD residue 

analytical method for the analysis of residues of novaluron in/on pome fruit, cabbage, and potato 

commodities. Briefly, residues in/on homogenized crop samples are extracted with 

methanol/water. The filtered extracts are concentrated to aqueous and repeatedly partitioned 

with hexane. The resulting hexane fractions are cleaned up by chromatography through an 

amino solid-phase extraction (NH2-SPE) cartridge, the eluate is evaporated to dryness, and 

residues are redissolved in ethyl acetate or hexane for analysis 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/on 

apples (including juice and wet pomace) and cabbage.

A second method, HPLC/UV, was submitted for the analysis of novaluron residues only in/on 

cotton commodities. Similarly, samples are extracted with acetonitrile (ACN) or ACN/water, 

and repeatedly 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 NH2-SPE for HPLC/UV analysis. The validated LOQ is 0.05 ppm for 

undelinted cottonseed, cotton gin byproducts, and the processed commodities of hulls, meal, and 

refined oil.

Successful independent laboratory validations (ILVs) of the GC/ECD and HPLC/UV methods 

have been completed with apples and undelinted cottonseed, respectively. Acceptable 

radiovalidation data have been submitted and reviewed in D325183 for the GC/ECD method. 

An interference study was requested and a specific single-analyte confirmatory method was 

submitted, reviewed, and considered acceptable (Memo, J. Langsdale, 21-OCT-2008; D355574).

The ACB concluded that based upon review of the submitted method validation data, without 

laboratory validation, that the GC/ECD and HPLC/UV methods appear suitable for food 

tolerance enforcement in plants (apples, cabbage, potatoes) and cotton. ACB recommended that 

the analytical methods do not need to be laboratory validated by EPA (DP306998). 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. Briefly, homogenized pepper samples were

extracted using methanol:water (70:30, v:v), filtered, partitioned into hexane, and cleaned up 

through a NH2-SPE column. Residues of novaluron were quantitated by GC/ECD.

The method was adequately validated using samples of untreated bell pepper fortified 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 novaluron 
Novaluron Summary of Analytical Chemistry and Residue Data DP#: 364237

Page 11 of 43

at 0.05 ppm. The lowest level of method validation (LLMV) was 0.05 ppm for novaluron in/on 

bell and non-bell pepper. 

Cucumber Data-Collection: Samples of cucumber were analyzed for residues of novaluron 

using a high-performance liquid chromatography method with tandem mass-spectrometry

detection (LC/MS/MS; Pyxant Method METH1585.00-00). Method METH1585-00.00 has not 

been previously reviewed by the EPA; however it is similar to the GC/ECD method previously

proposed for enforcement purposes. Briefly, samples of cucumber were extracted twice using 

methanol:water (70:30, v:v). The extract was filtered and diluted with extraction solvent for 

LC/MS/MS analysis. 

Prior to the analysis of field samples, the method was validated using samples of untreated 

cucumber fortified with novaluron at 0.05-25.2 ppm. In addition, the method was 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 analyzed for residues of novaluron 

using a method similar to the GC/ECD enforcement method. Briefly, homogenized cantaloupe 

samples were extracted using methanol:water (70:30, v:v), filtered, partitioned into ethyl acetate, 

and cleaned up through an NH2-SPE column. Residues of novaluron were quantitated by 

GC/ECD.

Prior to the analysis of field samples, the method was validated using samples of untreated 

cantaloupe fortified at 0.05-5.0 ppm. In addition, the method was validated concurrently with 

the analysis 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 analyzed 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 NH2-SPE column. Residues of novaluron were 

quantitated by GC/ECD.

Prior to the analysis of field samples, the method was validated using samples of untreated 

summer squash fortified at 0.05-5.0 ppm. In addition, the method was validated concurrently 

with the analysis 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 

using a method similar to the GC/ECD enforcement method. Briefly, homogenized strawberry

samples were extracted using methanol:water (70:30, v:v), filtered, partitioned into ethyl acetate, 

and cleaned up through an NH2-SPE column. Residues of novaluron were quantitated by

GC/ECD.

Prior to the analysis of field samples, the method was adequately validated using samples of 

untreated strawberry fortified with novaluron at 0.05-5.0 ppm. In addition, the method was 

validated concurrently with the analysis of field samples, using samples of untreated strawberry

fortified with novaluron at 0.05-5.0 ppm. The LLMV was 0.05 ppm for novaluron in/on 
Novaluron Summary of Analytical Chemistry and Residue Data DP#: 364237

Page 12 of 43

strawberry. 

Snap Bean Data-Collection: Samples of snap bean were analyzed for residues of novaluron 

using a method similar to the GC/ECD enforcement method. Briefly, 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 analysis 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 concurrently 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. Briefly, homogenized dry bean seed

samples were extracted using methanol:water (70:30, v:v), filtered, partitioned into hexane, and 

cleaned up through a NH2-SPE column. Residues of novaluron were quantitated by GC/ECD. 

Prior to the analysis 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 concurrently 

with the analysis 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 analyzed for residues of novaluron 

using a method similar to the GC/ECD enforcement method. Briefly, 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 analysis 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 plants (apple, cabbage, 

cotton, and potato). The enforcement method, with minor modifications, was used for data 

collection and the methods were adequately validated in conjunction with the bell and non-bell 

pepper, cucumber, cantaloupe, summer squash, strawberry, snap bean, dry bean seed, and Swiss 

chard field trials associated with the new uses 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 guidelines in PAM I, Appendix II (JAN1994). The results indicate that novaluron is not adequately recovered by 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.

860.1380 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 concurrent storage stability data was 

submitted for blueberries, mustard greens, and peaches in PP#8E7425, which demonstrated that 

fortified residues of novaluron are relatively stable under frozen conditions in/on blueberry, 

mustard greens, and peaches for up to 150 days, 464 days, and 116 days, 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 which 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 foliage 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 stability data for these commodities, no 

additional data will be required in consideration of the stability of novaluron in/on other crop 

matrices.

Concurrent storage stability data for cucumbers and non-bell peppers were not generated. 

Current Agency 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 

[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 tomato and apple may be extended to cucumbers for the purpose of these residue trials. The 

freezer storage stability study for bell peppers may be translated to non-bell peppers. 

The storage durations and conditions of samples from the crop field trial studies submitted to 

support this petition are presented in Table 4.

Table 4. Summary of Storage Conditions and Durations of Samples from Crop Field Trials. 

Matrix Storage 

Temperature (°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 months1).

Cantaloupe -40 to -6

86-164 days2

(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 days2

(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 days3

(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 days4

(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 days4

(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 days4

(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 days5

(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 D285474, 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: In conjunction with previously submitted storage stability data for novaluron on a 

variety of crops, the concurrent storage stability 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 these 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. 

860.1480 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

Six 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/A 
Novaluron 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 0.234-0.245 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 seasonal 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

PHI to 0.22 ppm at the 4-day PHI, and then increased to 0.28 and 0.37 ppm at the 8- and 11-day

PHIs, respectively. Overall, the residue decline trial indicated that residues generally stayed the 

same with increasing PHIs for bell peppers. The side-by-side 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. Summary of Residue Data from Crop Field Trials with Novaluron (Bell and Non-Bell Peppers).

Commodity

Total Applic. Rate

(lb ai/A)

[g ai/ha]

PHI 

(days)

Residue Levels1(ppm)

n Min. Max. HAFT2 Median Mean Std. Dev.

Treated with EC formulation

Pepper, bell 0.234-0.244

[262.2-273.5] 1; 23

18 <0.05 0.37 0.37 0.07 0.14 0.11

Pepper, nonbell0.240-0.245

[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 reported 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 peppers, 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 pepper 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 for 
Novaluron Summary of Analytical Chemistry and Residue Data DP#: 364237

Page 16 of 43

fruiting vegetable 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 by 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 for 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 tolerance 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 (MI, 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 maturity, 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 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 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. Summary of Residue Data from Crop Field Trials with Novaluron (Cucumber).

Commodity

Total Applic. Rate

(lb ai/A)

[g ai/ha]

PHI 

(days)

Residue Levels (ppm)1

n Min. Max. HAFT2 Median 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 for 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 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 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 novaluron. 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 

yielded 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 from Crop Field Trials with Novaluron (Cantaloupe).

Commodity

Total Applic. Rate

(lb ai/A)

[g ai/ha]

PHI 

(days)

Residue Levels (ppm)1

n Min. Max. HAFT2 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 

applications 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. Summary of Residue Data from Crop 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. HAFT

2 Median Mean Std. Dev.

Summer squash 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-average 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 proposed 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 Tolerances Based on Field Trial Data SOP to determine appropriate tolerance 

levels; see Appendix I. Because the cucumber residues were all below the LOQ (0.05 ppm), the 

MLE and MRL spreadsheets 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: 47705805.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 consisted 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 from 0.153 ppm at the 0-day PHI 

to 0.174 ppm at the 1-day PHI and 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. Summary of Residue Data from Crop Field Trials with Novaluron (Strawberry).

Commodity

Total Applic. Rate

(lb ai/A)

[g ai/ha]

PHI 

(days)

Residue Levels1(ppm)

n Min. Max. HAFT2 Median Mean Std. Dev.

Strawberry 0.238-0.251

[267-281] 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 PHI for strawberry. The label contains 

separate use 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 

PHI for the strawberry field trials; however, the RTI is 7 days as opposed to 14 days for 

strawberries. Although the RTI for 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 using 7- to 8-day RTIs. 

The field trial data for strawberry were entered into the Agency’s tolerance spreadsheet as 

specified by the Guidance for Setting Pesticide Tolerances Based on Field Trial Data SOP to 

determine appropriate tolerance levels; see Appendix 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: 47705806.der.doc

Fourteen snap bean trials were conducted in the U.S. and Canada in NAFTA Growing Zones 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

RTIs, for a total rate of 0.236-0.263 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 trial, 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 WI04), foliage samples consisted of the entire above-ground portion of the plant, but there is 

no indication as to whether or not the pods were removed. In the remaining trial (TN04), the 

foliage sample consisted of leaves only.

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 seeds 
Novaluron 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 generally 

stayed the same with increasing PHIs for snap bean pods with seeds and snap bean foliage 

without pods. 

TABLE 16. Summary of Residue Data from Crop Field Trials with Novaluron (Snap Beans).

Commodity

Total Applic. 

Rate

(lb ai/A)

[g ai/ha]

PHI 

(days)

Residue Levels1(ppm)

n Min. Max. HAFT2 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 foliage3 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 leaves5 0.240

[269.0] 3 2 8.1 10 9.1 9.1 9.1 1.3

All Snap bean foliage6 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 for 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 PHI data is 

acceptable for this petition. 

The field trial data for snap beans were entered into the Agency’s tolerance spreadsheet as 

specified by 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 (0.60 ppm) for residues of novaluron in/on snap beans.

Dry Bean

DER Reference: 47705807.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 made 
Novaluron 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 applications 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 days 

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 PHI for 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 separately (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. Summary of Residue Data from Crop 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. HAFT2 Median Mean Std. Dev.

Dry bean 0.237-0.249; 0.402

[266-279; 451] 1; 23

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 harvested 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 Data 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: 47705808.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 ground 

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 

formulation 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. Summary of Residue Data from Crop Field Trials with Novaluron (Swiss Chard).

Commodity Total Applic. Rate 

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

PHI 

(days)

Residue Levels (ppm)

n Min. Max. HAFT1 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 by 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 food and feed are not relevant to these 

commodities

860.1650 Submittal of Analytical Reference Standards

Analytical reference standards for novaluron are currently available at the EPA National 

Pesticide Standards Repository and will expire on 22-NOV-2010 (personal communication with 

Theresa Cole, 25-JUN-2009). 
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-FEB2004; D297646). Based on the results of the confined rotational crop study, the appropriate PBI 

for all non-labeled crops is 30 days (Memo, G. Kramer, 22-MAR-2004; D285474). 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 incomplete because certain 

rotational crop commodities (turnip tops and wheat forage, hay, and grain) were not analyzed or 

included in the study and crops were planted at only one location (Memo, G. Kramer, 07-FEB08; DP# 379033). Although incomplete, the data 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 0.9-1X 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 novaluron

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-methoxyethoxy)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 commodities in the table below. Compliance with the tolerance 

levels specified below is to be determined by measuring only novaluron (N-[[[3-chloro-4-[1,1,2-

trifluoro-2-(trifluoromethoxy)ethoxy]phenyl]amino]carbonyl]-2,6-difluorobenzamide) in or on 

the following raw agricultural commodities:”

A summary of the recommended tolerances for the current petition are listed in Table 20. A 

revised Section F is requested which reflects the recommended tolerances and commodity

definitions presented in Table 20. HED notes that cocona, African eggplant, pea eggplant, 

scarlet eggplant, goji berry, garden huckleberry, martynia, 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 MRLs have been established for novaluron in/on the proposed 

commodities. Canada is currently 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 
Novaluron Summary of Analytical Chemistry and Residue Data DP#: 364237

Page 24 of 43

peppers at 0.80 ppm and 0.90 ppm, respectively (personal communication with Melissa 

Watchorn 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

Vegetable, 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 Novaluron Analytical Methods in 

PAM Vol II as a Letter Method.

From: S. Levy

To: M. Wirtz (FDA)

Date: 09/15/04
Novaluron 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 Analytical 

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 Analytical Enforcement 

Methods for Plant and Livestock Raw Agricultural Commodities (RACs).

From: S. Levy

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 Tolerances for Use on 

Brassica, head and stem, subgroup 5A (PP#4E6834) and Label Amendment for 

New Use on Pome Fruit (PP#2F6430). Summary of Analytical Chemistry and 

Residue Data.

From: S. Levy

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. Levy

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 Analytical Chemistry and 

Residue Data.

From: G. Kramer

Date: 02/07/08
Novaluron 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:S10954:PY-S:(703)603-8866:7509P:RAB1

Template Version September 2005
Novaluron 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 tolerance

 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 Identifier: Decision Numbers: PC Code: 124002; 

Decision Number: 407555

Residue definition (step 8/CXL): novaluron (fat soluble) Reviewer/Branch: J. Van Alstine/RAB1

Residue definition: Novaluron only

Crop (s) MRL (mg/kg) Crop(s) Tolerance (ppm)

Tomato 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 0.20

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) MRL (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 Crop 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 crops, tomatoes (previously submitted; Memo, G. 

Kramer, 7-FEB-2008; D379033) and bell and non-bell peppers (current petition). The bell 

pepper field trial data represented 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

represented application rates of 0.240-0.245 lb ai/A (3 applications at 0.080-0.082 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 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 Tables I.1 and I.2.

As 3 of the 18 bell pepper field trial sample results and 4 of the 8 non-bell 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 by the Guidance for Setting Pesticide Tolerances Based on Field Trial Data SOP. 

Visual inspection of the lognormal probability plots (Figures I.1; I.3) and the results from the 

approximate Shapiro-Francia test statistics (Figures I.2; I.4) indicated that the datasets were

reasonably 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 95th percentile and the point estimate of the 99th percentile should be selected as 

the tolerance value. Using the rounding procedure as outlined in the SOP, the 95% UCL on the 

95th percentile rounds to the value 0.80 ppm and the point estimate of the 99th percentile rounds 

to the value 0.80 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 reasonably 

lognormal, the minimum of the 95% UCL on the 95th percentile and the point estimate of the 99th

percentile should be selected as the tolerance value. Using the rounding procedure as outlined in 

the SOP, the median 95th UCL rounds 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 Data Used to Calculate Tolerance for Novaluron 

in/on Bell Peppers.

Regulator: EPA

Chemical: Novaluron (0.83 EC Formulation) 

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 Data Used to Calculate Tolerance for Novaluron 

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. Lognormal Probability Plot of Novaluron Field Trial Data for Bell Peppers.

Lognormal Probability Plot

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

1.0000

0.5000

0.2500

0.1250

0.0625

0.0313

0.0156

y = 0.8426x - 2.2898

R

2

 = 0.9249

Percentiles

Concentrations EPA Novaluron (0.83 EC Formulation) FROM MLE Calculator Peppers(Bell) 1-2 Days 0.234-

0.244 lb ai/A IR-4
Novaluron 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+3SD
Novaluron Summary of Analytical Chemistry and Residue Data DP#: 364237

Page 32 of 43

Figure I.3. Lognormal 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, Cantaloupe, and Summer Squash (Cucurbit Vegetables Crop Group 9)

The dataset used to establish a tolerance for novaluron in/on cucurbit vegetables crop group 9 

consisted of field trial data for the representative crops, cucumber, muskmelon, and summer 

squash, representing 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 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 for cantaloupe and summer squash are 

provided in Tables I.3 and I.4. All cucumber samples 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 by the Guidance for Setting Pesticide Tolerances Based on Field Trial Data 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

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

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

Percentiles

Concentrations

EPA Novaluron (0.83 EC Formulation)From MLE Calculator Non-Bell Pepper 1-2 Days 0.240-

0.245 lb ai/A IR-4
Novaluron Summary of Analytical Chemistry and Residue Data DP#: 364237

Page 33 of 43

Visual inspection of the lognormal probability plots (Figures I.5; I.7) and the results from the 

approximate Shapiro-Francia test statistics (Figures I.6; I.8) indicated that the datasets were

reasonably 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 95th percentile 

and the point estimate of the 99th percentile should be selected as the tolerance value. Using the 

rounding procedure as outlined in the SOP, the 95% UCL on the 95th percentile rounds to the 

value 0.15 ppm and the point estimate of the 99th percentile rounds to the value 0.15 ppm (Figure 

I.6). Since the field trial data for novaluron on summer squash represent a small dataset (i.e., less

than 15 samples) and are reasonably lognormal, the minimum of the 95% UCL on the 95th

percentile and the point estimate of the 99th percentile should be selected as the tolerance value. 

Using the rounding procedure as outlined in the SOP, the 95% UCL on the 95th percentile rounds 

to the value 0.10 ppm and the point estimate of the 99th percentile rounds to the value 0.09 ppm 

(Figure I.8). The recommended tolerance for cucurbit vegetables 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 0.047
Novaluron Summary of Analytical Chemistry and Residue Data DP#: 364237

Page 34 of 43

Figure I.5. Lognormal 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

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

1.0000

0.5000

0.2500

0.1250

0.0625

0.0313

0.0156

y = 0.478x - 3.1413

R

2

 = 0.9705

Percentiles

Concentrations

EPA Novaluron (0.83 EC Formulation)USING MLE Cantaloupe 1 Day 0.239-0.245 lb ai/A IR-4
Novaluron 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. Lognormal 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 Berry Crop Subgroup 13-07G)

The dataset used to establish a tolerance for novaluron in/on low-growing berry crop subgroup 

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 by 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 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 lognormal 

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

Lognormal Probability Plot

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

1.0000

0.5000

0.2500

0.1250

0.0625

0.0313

0.0156

y = 0.3746x - 3.2952

R

2

 = 0.9728

Percentiles

Concentrations 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+3SD
Novaluron 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 95th percentile and 

the point estimate of the 99th percentile should be selected as the tolerance value. Using the 

rounding procedure as outlined in the SOP, the 95% UCL on the 95th percentile rounds to the 

value 0.45 ppm and the point estimate of the 99th 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 

berry crop subgroup 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: Strawberry

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

0.1080
Novaluron Summary of Analytical Chemistry and Residue Data DP#: 364237

Page 37 of 43

Figure I.9. Lognormal Probability Plot of Novaluron Field Trial Data for Strawberries.

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

Snap Beans

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 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 I.6.

The novaluron snap bean dataset was entered into the tolerance spreadsheet as specified by 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.12) 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 95th percentile 

and the point estimate of the 99th percentile should be selected as the tolerance value. Using the 

rounding procedure as outlined in the SOP, the 95% UCL on the 95th 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

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

1.0000

0.5000

0.2500

0.1250

0.0625

0.0313

y = 0.5432x - 2.098

R

2

 = 0.9727

Percentiles

Concentrations

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

Page 38 of 43

value 0.60 ppm and the point estimate of the 99th percentile rounds to the value 0.60 ppm (Figure 

I.12). Therefore, 0.60 ppm is the recommended tolerance 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

0.100
Novaluron Summary of Analytical Chemistry and Residue Data DP#: 364237

Page 39 of 43

Figure I.11. Lognormal 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 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 I.7.

The novaluron Swiss chard dataset was entered into the tolerance spreadsheet as specified by 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.13) and the results from the approximate Shapiro-Francia test statistic 

(Figure I.14) 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 95th percentile 

Lognormal Probability Plot

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

1.0000

0.5000

0.2500

0.1250

0.0625

0.0313

y = 0.5646x - 1.8769

R

2

 = 0.9562

Percentiles

Concentrations

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+3SD
Novaluron Summary of Analytical Chemistry and Residue Data DP#: 364237

Page 40 of 43

and the point estimate of the 99th percentile should be selected as the tolerance value. Using the 

rounding procedure as outlined in the SOP, the 95% UCL on the 95th percentile rounds to the 

value 25 ppm and the point estimate of the 99th 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 Formulation)

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. Lognormal Probability Plot of Novaluron Field Trial Data for Swiss Chard.

Lognormal Probability Plot

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

7.0000

3.5000

1.7500

y = 0.4978x + 1.3387

R

2

 = 0.9173

Percentiles

Concentrations

EPA Novaluron (0.83 EC Formulation) Swiss Chard 1 Day 0.237-0.243 lb ai/A IR-4
Novaluron 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 (only 1 trial had a 2-day PHI). As specified by 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 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 ShapiroFrancia test statistic (Figures I.16) indicated that the datasets were 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 95th percentile and 

the point estimate of the 99th percentile should be selected as the tolerance value. Using the 

rounding procedure as outlined in the SOP, the 95% UCL on the 95th percentile rounds to the 

value 0.30 ppm and the point estimate of the 99th percentile rounds to the value 0.30 ppm (Figure 

I.16). Therefore, 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 days)

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+3SD
Novaluron 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. Lognormal 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

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

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

Percentiles

Concentrations EPA Novaluron (0.83 EC Formulation)With MLE Dry Bean 1 Day (one trial--2 days) 0.237-

0.249 lb ai/A IR-4
Novaluron 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