Novaluron Summary of Analytical Chemistry and Residue Data DP#: 374420

Page 1 of 24

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, D.C. 20460

OFFICE OF PREVENTION, PESTICIDES,

AND TOXIC SUBSTANCES

MEMORANDUM

Date: 23-FEB-2010

SUBJECT: Novaluron. Petition for the Establishment of Permanent Tolerances for Residues 

of Novaluron in/on Grain Sorghum. Summary of Analytical Chemistry and 

Residue Data.

PC Code: 124002 DP Barcode: D374420

Decision No.: 407899 Registration No.: 66222-35

Petition No.: 9F7547 Regulatory Action: Amended Section 3

Risk Assessment Type: NA Case No.: NA

TXR No.: NA CAS No.: 116714-46-6

MRID No.: 47727201 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: John Hebert (RM 07)/ Jennifer Gaines

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, 

sugarcane, bushberry subgroup 13-07B, Brassica, leafy greens (subgroup 5B), turnip greens, and 

stone fruit (crop group 12). Registrations are pending for fruiting vegetables group 8, cucurbit 

vegetable group 9, low growing berry subgroup 13-07G (except lowbush blueberry), 

miscellaneous fruiting vegetables, snap bean, dry bean seed, and Swiss chard. 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), a suspension concentrate (SC), or a water-dispersible granular (WDG).
Novaluron Summary of Analytical Chemistry and Residue Data DP#: 374420

Page 2 of 24

Under petition 9F7547, MANA requests the establishment of a permanent tolerances for residues 

of the insecticide novaluron, N-[[[3-chloro-4-[1,1,2-trifluoro-2-

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

Grain sorghum, grain .......................................................3 ppm

Grain sorghum, aspirated grain fractions.......................25 ppm

Grain sorghum, forage .....................................................6 ppm

Grain sorghum, stover....................................................40 ppm

To support the submission for permanent tolerances for residues of novaluron in/on grain 

sorghum grain, forage, stover, and aspirated grain fractions (AGF), MANA proposes tolerance 

increases for residues of the insecticide novaluron, N-[[[3-chloro-4-[1,1,2-trifluoro-2-

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

commodities as follows:

Hog muscle .................................................................0.07 ppm

Hog liver .....................................................................0.15 ppm

Hog kidney..................................................................0.15 ppm

Hog fat ..........................................................................1.5 ppm 

Poultry muscle ..............................................................0.4 ppm

Poultry liver ..................................................................0.8 ppm

Poultry kidney...............................................................0.8 ppm

Poultry fat......................................................................7.0 ppm

Eggs...............................................................................1.5 ppm

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

®

0.83EC Insecticide 

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

The sorghum label proposes a maximum seasonal Rimon®application rate of 0.23 lb ai/A (0.058 

to 0.078 lb ai/A/application) with 7- to 14-day retreatment intervals (RTIs) and a 14-day

preharvest interval (PHI). The field trial data supports PHIs of 7 days for forage and 14 days for 

grain and stover, as well as the application rates for grain sorghum specified in the label. A 

revised Section B is requested which specifies that the use of adjuvants/surfactants on grain 

sorghum 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 for petition 9F7547 

should also specify that the label is for “grain sorghum” as opposed to “sorghum” and specify

separate PHIs for grain sorghum forage (7 days), grain (14 days), and stover (14 days). 

The nature of the residue in plants is understood based on acceptable plant metabolism studies 

reflecting foliar uses on apples, cabbage, cotton, and potatoes. The HED Metabolism 

Assessment Review Committee (MARC) concluded that the residue of concern in plants is 

novaluron only for tolerance enforcement and risk assessment purposes (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 hen 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).
Novaluron Summary of Analytical Chemistry and Residue Data DP#: 374420

Page 3 of 24

The available confined rotational crop study is adequate. The HED MARC has determined that 

for tolerance assessment and risk assessment, parent only is the residue of concern (Memo, G. 

Kramer et al., 03-FEB-2004; D297646). Based on the results of the confined rotational crop 

study, the appropriate 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; Memo, S. Levy, 15-SEP-2004; D307595). 

Samples of grain sorghum forage, grain, stover, aspirated grain fractions (AGF), and flour from 

the field trials and processing studies were analyzed for residues of novaluron using a liquid 

chromatography method with tandem mass-spectrometric detection (LC/MS/MS) method that is 

similar to the GC/ECD enforcement method. Acceptable method validation and concurrent 

method recovery data were submitted with the petition. 

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 (Memo, S. Levy, 19-OCT-2005; D322359). 

Concurrent storage stability data for grain sorghum forage, grain, AGF, flour, and stover were 

not generated. No suitable freezer storage stability data have been submitted to support the grain 

sorghum forage, grain, AGF, flour, and stover frozen storage intervals for the submitted study. 

Therefore, the data for grain sorghum are classified as scientifically acceptable pending 

submission of freezer storage stability data for residues of novaluron in/on grain sorghum forage, 

grain, AGF, and stover. 

The submitted field trial residue data for grain sorghum forage, grain, and stover are adequate to 

support the establishment of the requested tolerances, pending the submission of storage stability

data. 

An acceptable processing study was submitted. The maximum residues of novaluron were 1.20 

ppm in/on the sorghum grain raw agricultural commodity (RAC), 16.0 ppm in/on the sorghum 

AGF, and 0.795 ppm in/on the sorghum flour, indicating processing factors of 13X for the 

sorghum AGF and 0.66X for sorghum flour. 

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

spreadsheet to determine appropriate tolerances. The output from the tolerance spreadsheet 

supports the MANA proposed tolerances of 3.0 ppm for grain sorghum, grain; 25 ppm for AGF; 

6.0 ppm for grain sorghum, forage; and 40 ppm for grain sorghum, stover. New reasonably 

balanced dietary burdens (RBDBs) were constructed based on the proposed new use on sorghum 

and support MANA’s proposed increases in the tolerances for poultry, fat to 7.0 ppm; poultry, 

meat to 0.40 ppm; poultry, liver to 0.80 ppm; poultry, kidney to 0.80 ppm; egg to 1.5 ppm; hog, 

meat to 0.07 ppm; and hog, fat to 1.5 ppm. The appropriate tolerance for both hog liver and hog 
Novaluron Summary of Analytical Chemistry and Residue Data DP#: 374420

Page 4 of 24

kidney is 0.10 ppm. Tolerances of 0.80 ppm and 0.10 ppm are also required for poultry, meat 

byproducts and hog, meat byproducts, respectively. 

No Codex, Canadian, or Mexican MRLs have been established for novaluron in/on grain 

sorghum forage, stover, grain, and AGF. 

Regulatory Recommendations and Residue Chemistry Deficiencies

Pending submission of revised Sections B and F (see requirements under Directions for Use, 

Storage Stability Data, and Proposed Tolerances), there are no residue chemistry issues that 

would preclude granting a conditional registration for the use of novaluron on grain sorghum. 

The proposed uses and the submitted data support the permanent tolerances for residues of the 

insecticide novaluron, including its metabolites and degradates, in or on the commodities listed

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 RACs:

Grain, aspirated fractions 25 ppm Poultry, fat 7.0 ppm

Sorghum, grain, grain 3.0 ppm Egg 1.5 ppm

Sorghum, grain, forage 6.0 ppm Hog, meat 0.07 ppm

Sorghum, grain, stover 40 ppm Hog, liver 0.10 ppm

Poultry, meat 0.40 ppm Hog, kidney 0.10 ppm

Poultry, liver 0.80 ppm Hog, meat byproducts 0.10 ppm

Poultry, kidney 0.80 ppm Hog, fat 1.5 ppm

Poultry, meat byproducts 0.80 ppm

A human-health risk assessment is forthcoming in a separate document (D364307). The residue 

chemistry database will support unconditional registration upon submission of data/information 

which adequately addresses the following issues: 

860.1200 Directions for Use

A revised Section B for petition number 9F7547 should be submitted which:

 Specifies that the use of adjuvants/surfactants on grain sorghum is prohibited;

 Specifies that the label is for “grain sorghum” as opposed to “sorghum;” 

 Specifies separate PHIs for grain sorghum forage (7 days), grain (14 days), and stover (14 

days); and

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

is prohibited. 

860.1380 Storage Stability Data

Storage stability data on grain sorghum forage, grain, AGF, and stover for up to 275, 253, 237,

and 245 days, respectively, are required. 

860.1550 Proposed Tolerances

 A revised Section F for petition number 9F7547 should be submitted which cites the 

appropriate CAS name for novaluron:
Novaluron Summary of Analytical Chemistry and Residue Data DP#: 374420

Page 5 of 24

“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 12. 

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

®

0.83EC Insecticide (0.83 lb/gal EC; EPA Reg. No. 66222-35)

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/cm3

at 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
Novaluron Summary of Analytical Chemistry and Residue Data DP#: 374420

Page 6 of 24

Table 2. Physicochemical Properties of Technical Grade Novaluron.

Parameter Value Reference

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

MANA submitted a draft label for Rimon

®

0.83EC Insecticide (EPA Reg. No. 66222-35) to 

include the proposed new use (see Table 3) on grain sorghum.

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

Grain Sorghum

Aerial/ 

Groundboom

0.83 lb/gal 

EC

[66222-35]

0.058-

0.078 3 0.23 14

A 7 to 14 day RTI is 

specified to protect new

growth. For the most 

effective control, fields 

should be scouted twice 

weekly. 

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. Applications of Rimon

®

0.83EC may also be made through sprinkler irrigation systems; use of other types of irrigation 

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

®

0.83EC Insecticide states that 

only registered crops may be rotated in a treated field within 30 days of application. 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 revised Section B is requested which specifies 

that the use of adjuvants/surfactants on grain sorghum 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 for petition 9F7547 should also specify that the label is for “grain 

sorghum” as opposed to “sorghum” and specify separate PHIs for grain sorghum forage (7 days), 

grain (14 days), and stover (14 days). 

Conclusions: The proposed label is adequate to allow evaluation of the residue data relative to 

the proposed new use on grain sorghum; however, a revised Section B is requested which: 

 specifies that the use of adjuvants/surfactants on grain sorghum is prohibited;

 specifies that the label is for “grain sorghum” as opposed to “sorghum;” 

 specifies separate PHIs for grain sorghum forage (7 days), grain (14 days), and stover (14 

days); and

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

is prohibited. 
Novaluron Summary of Analytical Chemistry and Residue Data DP#: 374420

Page 7 of 24

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 (Memo, G. Kramer, 22-MAR-2004; D285474). 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 (Memo, G. Kramer, 22-MAR-2004; D285474). The HED MARC determined that 

the residue of concern in crops for purposes of tolerance enforcement and risk assessment is 

novaluron only (Memo, G. Kramer et al., 03-FEB-2004; D297646). 

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 hen 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).

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.
Novaluron Summary of Analytical Chemistry and Residue Data DP#: 374420

Page 8 of 24

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).

Grain Sorghum Data-Collection: Samples of grain sorghum forage, grain, stover, AGF, and 

flour were analyzed for residues of novaluron using a method similar to the GC/ECD 

enforcement method. Briefly, homogenized samples of grain sorghum forage, grain, stover,

AGF, and flour were extracted twice with ACN and the extracts were isolated by centrifugation, 

combined, and diluted with ACN. Residues of novaluron were quantitated using LC/MS/MS. 

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

sorghum forage, grain, and stover fortified with novaluron at 0.05-2.5 ppm. The method was 

also validated concurrently with the analysis of field samples, using samples of untreated forage, 

grain, and stover fortified with novaluron at 0.05-5.0, 00.05-2.5, and 0.05-20 ppm, respectively. 

The validated LOQ for novaluron was 0.05 ppm in each sorghum matrix. 

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 method was adequately validated in conjunction with the grain sorghum field 

trials associated with the new use 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. 

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)

Residue Chemistry Memo, DP# 364237, 04-DEC-2009, J.L. Van Alstine (PP#9E7546)

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 
Novaluron Summary of Analytical Chemistry and Residue Data DP#: 374420

Page 9 of 24

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. 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 4.9 months, 15.3 months, and 3.8 months, respectively. Storage 

stability data have also been submitted which demonstrate that fortified residues of novaluron are 

relatively stable under frozen conditions in/on bell pepper for 6.7 months, cantaloupe for 7.0 

months, summer squash for 9.4 months, strawberry for 11.7 months, snap bean pods with seeds 

for 8.6 months, snap bean foliage for 8.7 months, dry bean seed for 5.0 months, and Swiss chard 

for 11.7 months. 

Concurrent storage stability data for sorghum forage, grain, AGF, flour, and stover were not 

generated. No suitable freezer storage stability data have been submitted to support the sorghum 

forage, grain, AGF, flour, and stover frozen storage intervals for the submitted study. Therefore, 

the data for grain sorghum are classified as scientifically acceptable pending submission of 

freezer storage stability data for residues of novaluron in/on grain sorghum forage, grain, AGF, 

and stover. 

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

Grain sorghum, forage -20 ± 5 185-275 days1

(6.1-9.0 months) None.

Grain sorghum, grain -20 ± 5 163-253 days1

(5.4-8.3 months) None.

Grain sorghum, stover -20 ± 5 168-245 days1

(5.5-8.1 months) None.

Grain sorghum, grain (RAC) Stored at ambient 

temperatures at the 

field site until 

delivered to 

processor within 

one day of harvest.

Stored frozen 

(temperature 

unspecified) at the 

processing facility.

Stored frozen (-20 

± 5 oC) at the 

analytical facility.

247 days2

(8.1 months) None.

Grain sorghum, AGF 237 days2

(7.8 months) None.

Grain sorghum, flour 246 days2

(8.1 months) None.

1 Actual storage duration from harvest to analysis. Samples were analyzed within 0-5 days of extraction.

2 Actual storage duration from collection/processing to analysis; samples were processed within 8-17 days of harvest and 

analyzed within 1 day of extraction.

Conclusions: The data for grain sorghum are classified as scientifically acceptable pending 

submission of freezer storage stability data for residues of novaluron in/on grain sorghum forage, 

grain, AGF, and stover for up to 275, 253, 237, and 245 days, respectively. Although this is a 

deficiency, HED recommends a conditional registration for the use of novaluron on grain 

sorghum. This decision is based on previously submitted storage stability data for various 

commodities which demonstrates the stability of novaluron in/on food commodities for up to 

15.3 months, which exceeds the longest storage time (9.0 months for grain sorghum forage) of 

the grain sorghum commodities in the field trials. The residue chemistry database will support 

an unconditional registration upon submission of adequate storage stability data along with 
Novaluron Summary of Analytical Chemistry and Residue Data DP#: 374420

Page 10 of 24

revised Sections B and F. 

860.1480 Meat, Milk, Poultry, and Eggs

Livestock dietary burdens

Residue Chemistry Memo, DP# 285474, 3/22/2004, G.F. Kramer (PP#2F6430)

Residue Chemistry Memo, DP# 315890, 5/10/2005, G.F. Kramer (PP#2F6430)

Residue Chemistry Memo, DP# 336897, 1/31/2008, S. J. Levy (PP#2F06430)

Residue Chemistry Memo, DP# 340137, 2/07/2008, G.F. Kramer (PP# 7E7199)

The potential for secondary transfer of novaluron residues of concern in meat, milk, and eggs 

exists because there are livestock feedstuffs associated with the proposed/registered novaluron 

uses. The livestock dietary burdens of novaluron are presented in Table 5 and reflect the most 

recent guidance from HED (Table 1, 6/08) concerning revisions of feedstuff percentages and 

constructing RBDBs. 

Table 5. Calculation of Dietary Burdens of Novaluron Residues to Livestock1.

Feedstuff Type2 % Dry 

Matter2 % Diet3 Recommended Tolerance (ppm)

Dietary Contribution 

(ppm)

4

Beef Cattle

Sorghum, grain, stover R 88 15 40.0 6.82

Sorghum, grain, grain CC 86 35 3.0 1.22

Sugarcane, molasses CC 75 5 0.5 0.033

Grains, aspirated fractions CC 85 5 25 1.47

Untreated CC -- 35 -- --

Cottonseed, meal PC 89 5 0.60 0.034

TOTAL BURDEN -- -- 100 -- 9.6

Dairy Cattle5

Sorghum, grain, forage R 35 40 6.0 6.86

Sorghum, grain, stover R 88 5 40.0 2.27

Sorghum, grain, grain CC 86 35 3.0 1.22

Apple, wet pomace CC 40 10 8.0 2.0

Cotton, undelinted seed PC 88 10 0.60 0.068

TOTAL BURDEN -- -- 100 -- 12.4

Poultry

Sorghum, grain, grain CC 86 75 3.0 2.25

Cottonseed, meal PC 89 20 0.60 0.12

Untreated PC -- 5 -- --

TOTAL BURDEN -- -- 100 -- 2.4

Swine

Sorghum, grain, grain CC 86 80 3.0 2.4

Untreated CC -- 5 -- --

Cottonseed, meal PC 89 15 0.60 0.09

TOTAL BURDEN -- -- 100 -- 2.5

1 Table prepared by Jerry Stokes; 29-OCT-2009.

2 R: roughage; CC: carbohydrate concentrate; PC: protein concentrate.

3 OPPTS 860.1000 Table 1 Feedstuffs (June 2008). 
Novaluron Summary of Analytical Chemistry and Residue Data DP#: 374420

Page 11 of 24

4 Contribution = ([tolerance /% DM] X % diet) for beef and dairy cattle; contribution = ([tolerance] X % diet) for poultry and 

swine.

5

Petition 8E7425 (Memo, J. Van Alstine, 09-SEP-2009; D357060) included a request for the use of novaluron on turnip greens; 

HED requested that the petitioner submit a new label which prohibits the use of novaluron on turnips harvested for the root and 

prohibits the feeding of turnip tops to livestock.

Expected secondary residues in ruminant meat and milk

To determine the need for revisions to the tolerances for novaluron residues of concern in milk 

and tissues, the anticipated secondary residues in cattle matrices were estimated using average 

transfer coefficients calculated from the maximum residues of novaluron observed at the 3.9-, 

12.6-, and 42.8-ppm dose levels (PP#2F6430). The transfer coefficients (calculated as residuelevel-to-feed ratios) are presented in Table 6. The transfer coefficient for each matrix was then 

used to calculate the expected secondary residues by multiplying the average transfer coefficient 

by the calculated dietary burden (Tables 7 and 8). 

Table 6. Residue-Level-to-Feed Ratios (Transfer Coefficients) in Dairy Cattle Milk and Tissues.

Matrix Maximum Residues 

(ppm)

Feeding Levels 

(ppm)

Transfer Coefficients (Average)

Whole milk 0.17, 0.43, 2.07

3.9, 12.6, 42.8

0.044, 0.034, 0.048, (0.042)

Muscle 0.09, 0.34, 0.56 0.023, 0.027, 0.013, (0.021)

Kidney 0.14, 0.35, 1.20 0.036, 0.028, 0.028, (0.031)

Liver 0.14, 0.41, 1.36 0.036, 0.033, 0.032, (0.034)

Fat (peritoneal) 2.25, 6.83, 12.89 0.577, 0.542, 0.301, (0.473)

Table 7. Expected Secondary Residues in Cattle Meat and Milk.

Matrix Dietary burden 

(ppm)

Secondary Residues 

(ppm)

1

Established Tolerance 

(ppm)

Recommended 

Tolerance (ppm)

Whole milk

12.4

0.52 1.0 1.0

Muscle 0.26 0.60 0.60

Kidney 0.38 1.0 1.0

Liver 0.41 1.0 1.0

Fat (peritoneal) 5.87 11 11

1 Calculated from dietary burden x average transfer coefficient from Table 6. 

Table 8. Expected Secondary Residues in Hog Meat.

Matrix Dietary burden 

(ppm)

Secondary Residues 

(ppm)

1

Established Tolerance 

(ppm)

Recommended 

Tolerance (ppm)

Muscle

2.5

0.05 0.01 0.07

Kidney 0.08 0.0120.10

Liver 0.08 0.0120.10

Fat (peritoneal) 1.2 0.05 1.5

1 Calculated from dietary burden x average transfer coefficient from Table 6.

2

In 40 CFR §180.598, the tolerance is for hog, meat byproducts. 

Expected secondary residues in poultry meat and eggs

To determine the need for tolerances for novaluron residues of concern in poultry meat and eggs, 

the anticipated secondary residues in poultry matrices were estimated using average transfer 

coefficients calculated from the maximum residues of novaluron observed in the hen metabolism 

study (0.12-, 0.36-, 1.2-ppm dose levels; PP#2F06430). The transfer coefficients (calculated as 

residue-level-to-feed ratios) are presented in Table 9. The transfer coefficient for each matrix 
Novaluron Summary of Analytical Chemistry and Residue Data DP#: 374420

Page 12 of 24

was then used to calculate the expected secondary residues by multiplying the average transfer 

coefficient by the calculated dietary burden (Table 10). 

Table 9. Residue-Level-to-Feed Ratios (Transfer Coefficients) in Poultry Eggs and Tissues.

Matrix Maximum 

Residues (ppm) Feeding Levels (ppm) Transfer Coefficients (Average)

Eggs (day 54) 0.063, 0.181, 0.702

0.12, 0.36, 1.2

0.52, 0.50, 0.58, (0.53)

Muscle 0.014, 0.031, 0.160 0.12, 0.086, 0.13, (0.11)

Liver 0.034, 0.096, 0.364 0.28, 0.27, 0.30, (0.28)

Kidney 0.039, 0.089, 0.368 0.32, 0.25, 0.31, (0.29)

Fat (abdominal) 0.323, 0.988, 3.011 2.7, 2.7, 2.5, (2.6)

Table 10. Expected Secondary Residues in Poultry Meat and Eggs.

Matrix Dietary burden 

(ppm)

Secondary Residues

(ppm)

1

Established Tolerance 

(ppm)

Recommended 

Tolerance (ppm)

Eggs (day 54)

2.4

1.3 0.05 1.5

Muscle 0.27 0.03 0.40

Liver 0.68 0.042

0.80

Kidney 0.70 0.042

0.80

Fat (abdominal) 6.4 0.40 7.0

1 Calculated from dietary burden x average transfer coefficient from Table 9.

2

In 40 CFR §180.598, the tolerance is for hog, meat byproducts. 

Conclusions: The currently established livestock tolerances are based on the following RBDBs 

for novaluron: 5.9 ppm for beef cattle, 2.3 ppm for dairy cattle, 0.12 for poultry, and 0.09 for 

swine (Memo G. Kramer, 07-FEB-2008; D340137). Based on the proposed/registered uses, the 

revised RBDBs for novaluron are 9.6 ppm for beef cattle, 12.4 ppm for dairy cattle, 2.4 for 

poultry, and 2.5 for swine. This increase in the RBDBs necessitates an increase in the tolerances

for secondary residues in/on poultry and hog commodities; however, no changes are necessary

for the tolerances for secondary residues in/on cattle, goat, horse, and sheep. The revised

tolerances for residues of novaluron in hog and poultry are as follows: 0.07 ppm in hog meat; 

0.10 ppm in hog liver, kidney, and meat byproducts; 1.5 ppm in hog fat; 1.5 ppm in eggs; 0.40 

ppm in poultry meat; 0.80 ppm in poultry liver, kidney, and meat byproducts; and 7.0 ppm in 

poultry fat. The petitioner is requested to submit a revised Section F reflecting these 

tolerances.

860.1500 Crop Field Trials

Grain Sorghum

DER Reference: 47727201.de1.doc

Twelve grain sorghum field trials were conducted in the U.S. during the 2007 growing season. 

Trials were conducted in North American Free Trade Agreement (NAFTA) Growing Zones 2 

(NC; 1 trial), 4 (AR; 1 trial), 5 (IL, KS, and NE; 4 trials), 6 (OK and TX; 1 trial each), 7 (NE, 1 

trial), and 8 (KS, OK, and TX; 1 trial each).

Each trial site consisted of one untreated plot and one treated plot. The treated plots received 

three broadcast spray applications of a 0.83 lb/gal EC formulation of novaluron (EPA Reg. No. 
Novaluron Summary of Analytical Chemistry and Residue Data DP#: 374420

Page 13 of 24

66222-35) at 0.076-0.081 lb ai/A per application, with 7- to 15-day RTIs, for a total rate of 

0.232-0.239 lb ai/A; forage samples were harvested after only two applications, for a total rate of 

0.156-0.160 lb ai/A. Applications were made using ground equipment in approximately 20-34 

GPA spray volumes, without an adjuvant. Samples of grain sorghum forage, grain, and stover 

were taken at normal harvest times, 6 to 7 days after the second application for forage and 13 to 

14 days after the last application for grain and stover. At the OK2 trial, cattle destroyed the crop 

after the second application and no grain or stover samples could be harvested. To evaluate 

residue decline, additional treated samples were also collected at the NE2 trial 1, 3, 10, and 14 

days after the second application (forage) and 10, 14, 17, and 21 days after the last application 

(grain and stover).

The results (see Table 11) indicate that residues of novaluron ranged from 0.620 to 4.82 ppm 

in/on 24 samples of treated sorghum forage harvested 6-7 days following foliar treatments with 

the 0.83 lb/gal EC formulation at a total rate of 0.156-0.160 lb ai/A. Novaluron residues ranged 

from 0.586 to 1.96 ppm in/on 22 samples of treated sorghum grain, and from 3.62 to 26.0 ppm 

in/on 22 samples of treated sorghum stover (adjusted to 88% dry matter) harvested 13-14 days 

following foliar treatments at a total rate of 0.232-0.239 lb ai/A.

In the residue decline trial, average residues of novaluron generally decreased in/on forage, from 

4.0 ppm at the 1-day PHI to 2.0 ppm at the 14-day PHI, and stover, from 6.7 ppm at the 7-day

PHI to 3.8 ppm at the 21-day PHI; average residues in/on grain were approximately the same at 

all sampling intervals.

Table 11. Summary of Residue Data from Crop Field Trials with Novaluron (Grain Sorghum).

Commodity Total Applic. 

Rate (lb ai/A)

PHI 

(days)

Residue Levels (ppm)

n Min. Max. HAFT1 Median Mean Std. Dev.

Sorghum forage 0.156-0.160 6-7 24 0.620 4.82 4.24 2.56 2.68 1.10

Sorghum grain

0.232-0.239

13-14 22 0.586 1.96 1.84 1.16 1.23 0.43

Sorghum stover213-14 22 3.62 26.0 24.0 10.7 12.6 6.23

1 HAFT = highest-average field trial.

2 The residues for grain sorghum stover have been adjusted to 88% dry matter. 

Conclusions: The number and locations of field trials are in accordance with OPPTS Guideline 

860.1500 for grain sorghum; however, as described above, grain and stover were not collected 

from one of the trials because cattle destroyed the crop after the second novaluron application. 

The field trial data reflect the proposed use rate and PHI for grain sorghum. 

The field trial data for grain sorghum forage, grain, and stover (adjusted to 88% dry matter) were 

entered into the Agency’s tolerance spreadsheet as specified by the Guidance for Setting 

Pesticide Tolerances Based on Field Trial Data Standard Operating Procedure (SOP) to 

determine appropriate tolerance levels; see Appendix I. The available data support the proposed 

tolerances of 6.0 ppm, 3.0 ppm, and 40 ppm for residues of novaluron in/on grain sorghum 

forage, grain, and stover, respectively.

860.1520 Processed Food and Feed

There are processed commodities associated with grain sorghum and a processing study on grain 

sorghum AGF and flour was submitted.
Novaluron Summary of Analytical Chemistry and Residue Data DP#: 374420

Page 14 of 24

Grain Sorghum AGF and Flour

DER Reference: 47727201.de2.doc

To determine the potential for residues of novaluron to concentrate in/on grain sorghum AGF 

and flour, sorghum plants at a single trial conducted in TX (NAFTA Growing Zone 6) during the 

2007 growing season received three foliar broadcast applications of a 0.83 lb/gal EC formulation 

of novaluron (EPA Reg. No. 66222-35) at 0.078 lb ai/A/application, with 9- to 11-day RTIs, for 

a total rate of 0.234 lb ai/A. Applications were made using ground equipment in ~29 GPA spray

volumes, without an adjuvant. Bulk samples of sorghum grain RAC were harvested 13 days 

following the last application and processed using simulated commercial procedures into AGF 

and flour. 

Residues of novaluron in/on grain were 1.20 ppm and residues were 16.0 and 0.795 ppm, 

respectively, in AGF and flour. These data indicate that residues of novaluron concentrate in 

AGF (13X) but do not concentrate in flour (processing factor of 0.66X). Sorghum flour is not 

considered to be a human food item in the U.S.

Conclusions: For grain sorghum AGF, the processed food data are classified as scientifically

acceptable pending submission of freezer storage stability data for grain sorghum grain and 

AGF. A tolerance value of 25 ppm [i.e., 1.84 ppm (HAFT) x 13 = 24 ppm] was calculated for 

AGF. 

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). 

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 commodities associated with the current petitions may be 

rotated. The available confined rotational crop study is adequate (Memo, G. Kramer, 22-MAR2004; D285474). In the submitted confined rotational crop study, the application rate (~0.089 lb 

ai/A) of the test substance was equivalent to 0.3X the maximum proposed seasonal rate of

application (0.27 lb ai/A) for cotton and potatoes. HED generally requires that the confined 

rotational crop study be conducted at 1.0X the proposed maximum seasonal rate for annual crops 

(or crops which can be rotated). However, as the total radioactive residue (TRR) was <0.005 

ppm in all of the rotated crop commodities, it is unlikely that significant residues would be 

present at 1X. 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. The HED MARC has determined that for tolerance 

assessment and risk assessment, parent only is the residue of concern (Memo, G. Kramer et al., 

03-FEB-2004; D297646). 

An additional field rotational crop study was submitted and considered incomplete because 

certain rotational crop commodities (turnip tops and wheat forage, hay, and grain) were not 
Novaluron Summary of Analytical Chemistry and Residue Data DP#: 374420

Page 15 of 24

analyzed or included in the study and crops were planted at only one location (Memo, G. 

Kramer, 07-FEB-08; D379033). 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. A summary of HED’s recommended tolerances for the current petition are listed in Table 

12. A revised Section F is requested which reflects HED’s recommended tolerances and 

commodity definitions presented in Table 12. 

No Codex, Canadian, or Mexican MRLs have been established for novaluron in/on grain 

sorghum. 

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.

Table 12. Tolerance Summary for Novaluron.

Commodity Proposed 

Tolerance (ppm)

HED-Recommended 

Tolerance (ppm)

Comments; 

Correct Commodity Definition

Grain sorghum, grain 3 3.0 Sorghum, grain, grain

Grain sorghum, aspirated 

grain fractions 25 25 Grain, aspirated fractions

Grain sorghum, forage 6 6.0 Sorghum, grain, forage

Grain sorghum, stover 40 40 Sorghum, grain, stover

Poultry, fat 7.0 7.0 

Poultry, muscle 0.4 0.40 Poultry, meat

Poultry, liver 0.8 0.80 

Poultry, kidney 0.8 0.80 

-- -- 0.80 Poultry, meat byproducts

Hog, fat 1.5 1.5 

Hog, muscle 0.07 0.07 Hog, meat

Hog, liver 0.15 0.10 

Hog, kidney 0.15 0.10 

-- -- 0.10 Hog, meat byproducts

Eggs 1.5 1.5 Egg

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 
Novaluron Summary of Analytical Chemistry and Residue Data DP#: 374420

Page 16 of 24

PAM Vol II as a Letter Method.

From: S. Levy

To: M. Wirtz (FDA)

Date: 09/15/04

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
Novaluron Summary of Analytical Chemistry and Residue Data DP#: 374420

Page 17 of 24

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

DP#: D357060

Subject: Novaluron. Petition for the Establishment of Permanent Tolerances for Residues 

of Novaluron in/on Bushberry Subgroup 13-07B; Brassica, Leafy Greens, 

Subgroup 5B; Turnip, Greens; and Fruit, Stone, Group 12. Summary of 

Analytical Chemistry and Residue Data.

From: J. L. Van Alstine

To: D. Rosenblatt /L. Nollen

Date: 09/09/09

DP#: D364237

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.

From: J. L. Van Alstine

To: B. Madden/L. Nollen

Date: 12/04/09

Attachments: 

International Residue Limit Status sheet

Appendix I - Tolerance-Assessment Calculations

cc: Julie L. Van Alstine (RAB1) 

RDI: G. Kramer (25-JAN-10), RAB1 Chemists (27-JAN-10)

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#: 374420

Page 18 of 24

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: 

DP#: 

Other Identifier: Decision Numbers: 

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)

Grain sorghum, grain 3

Grain sorghum, aspirated grain 

fractions 25

Grain sorghum, forage 6

Grain sorghum, stover 40

Poultry, fat 7.0

Poultry meat 0.01 (*)(fat) Poultry, meat 0.4

Poultry, edible offal of 0.01 (*) Poultry, liver 0.8

Poultry, kidney 0.8

Hog, fat 1.5

Meat (mammalian other 

than marine)

10 (fat) Hog, meat 0.07

Hog, liver 0.15

Hog, kidney 0.15

Eggs 0.01 (*) Eggs 1.5

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)

Meat of hogs 0.01

Meat byproducts of hogs 0.01

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#: 374420

Page 19 of 24

Appendix I. Tolerance-Assessment Calculations.

Grain Sorghum Forage, Grain, and Stover

The dataset used to establish a tolerance for novaluron on grain sorghum consisted of field trial 

data for forage, grain, and stover. The forage field trial data represented application rates of 

0.156-0.160 lb ai/A (2 applications at 0.077-0.081 lb ai/A per application) with a 6- to 7-day

PHI. The grain and stover field trial data represented application rates of 0.232-0.239 lb ai/A (3

applications at 0.076-0.080 lb ai/A per application) with 13- to 14-day PHIs. 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, I.2, and I.3.

The grain sorghum forage, grain, and stover datasets were entered into the tolerance spreadsheet 

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

Grain sorghum stover residues were adjusted to 88% dry matter. All field trial sample results for 

forage, grain, and stover were above the LOQ (lowest level of method validation (LLMV) = 0.05 

ppm). Visual inspection of the lognormal probability plots (Figures I.3; I.5) and the results from 

the approximate Shapiro-Francia test statistic (Figure; I.4; I.6) indicated that the dataset was 

reasonably lognormal for grain sorghum grain and stover. Visual inspection of the lognormal 

probability plot (Figure I.1) and the Shapiro-Francia test statistic (Figure I.2) for sorghum forage 

indicated that the lognormality assumption should be rejected for grain sorghum forage. 

Since the field trial data for novaluron on grain sorghum grain and stover 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 values 3.0 ppm and 40 ppm and the point 

estimate of the 99th percentile rounds to the values 3.0 ppm and 40 ppm for grain sorghum grain 

and stover, respectively (Figures I.4; I.6). For grain sorghum forage, the mean + 3 SD rounds to 

6.0 ppm (Figure I.2). Therefore, 6.0 ppm, 3.0 ppm, and 40 ppm are the recommended tolerance 

levels for novaluron in/on grain sorghum forage, grain, and stover. 

Table I.1. Residue Data Used to Calculate Tolerance for Novaluron 

in/on Sorghum, Grain, Forage.

Regulator: EPA

Chemical: Novaluron (0.83EC Formulation)

Crop: Sorghum, Grain, Forage

PHI: 6-7 Days

App. Rate: 0.156-0.160 lb ai/A

Submitter: MANA/Chemtura

MRID Citation: 47727201

Residues of Novaluron (ppm)

3.4

4.58

1.78

1.84

2.68

2.85
Novaluron Summary of Analytical Chemistry and Residue Data DP#: 374420

Page 20 of 24

Table I.1. Residue Data Used to Calculate Tolerance for Novaluron 

in/on Sorghum, Grain, Forage.

2.18

2.5

2.7

4.18

2.06

2.36

2.82

4.18

2.62

3.82

1.51

2.21

0.62

0.848

2.02

2.12

3.65

4.82

Figure I.1. Lognormal Probability Plot of Novaluron Field Trial Data for Sorghum, Grain, Forage.

Lognormal Probability Plot

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

5.0000

2.5000

1.2500

0.6250

0.3125

y = 0.4805x + 0.8883

R

2

 = 0.9055

Percentiles

Concentrations

EPA Novaluron (0.83 EC Formulation) Sorghum Grain, FORAGE 6-7 Days 0.156-0.160 lb ai/A

MANA/Chemtura
Novaluron Summary of Analytical Chemistry and Residue Data DP#: 374420

Page 21 of 24

Figure I.2. Tolerance Spreadsheet Summary of Novaluron Field Trial Data for Sorghum, Grain, Forage.

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

in/on Sorghum, Grain, Grain.

Regulator: EPA

Chemical: Novaluron (0.83EC Formulation)

Crop: Sorghum, Grain, Grain.

PHI: 13-14 Days

App. Rate: 0.232-0.239 lb ai/A

Submitter: MANA/Chemtura

MRID Citation: 47727201

Residues of Novaluron (ppm)

0.586

0.624

0.638

0.719

0.91

1.47

1.74

1.94

0.997

1.05

1.32

1.55

1.05

1.07

0.935

1.26

1.07

1.25

1.69

1.85

1.42

1.96

Regulator: EPA

Chemical: Novaluron (0.83 EC Formulation)

Crop: Sorghum Grain, FORAGE

PHI: 6-7 Days

App. Rate: 0.156-0.160 lb ai/A

Submitter: MANA/Chemtura

n: 24

min: 0.62

max: 4.82

median: 2.56

average: 2.68

95th Percentile 99th Percentile 99.9th Percentile

4.5 6.0 7.0

(6.0) (7.0) (--)

6.0 8.0 12

(8.0) (12) (--)

8.0

6.0

14

0.9055

0.05 >= p-value > 0.01 : 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#: 374420

Page 22 of 24

Figure I.3. Lognormal Probability Plot of Novaluron Field Trial Data for Sorghum, Grain, Grain.

Figure I.4. Tolerance Spreadsheet Summary of Novaluron Field Trial Data for Sorghum, Grain, Grain.

Table I.3. Residue Data Used to Calculate Tolerance for Novaluron 

in/on Sorghum, Grain, Stover.

Regulator: EPA

Chemical: Novaluron (0.83EC Formulation)

Crop: Sorghum, Grain, Stover (Adjusted to 88% dry matter)

PHI: 13-14 days

App. Rate: 0.232-0.239 lb ai/A

Submitter: MANA/Chemtura

MRID Citation: 47727201

Residues of Novaluron (ppm)

22.07

25.96

8.20

9.78

14.80

15.21

9.06

Regulator: EPA

Chemical: Novaluron (0.83 EC Formulation)

Crop: Sorghum Grain, GRAIN

PHI: 13-14 Days

App. Rate: 0.232-0.239 lb ai/A

Submitter: MANA/Chemtura

n: 22

min: 0.59

max: 1.96

median: 1.16

average: 1.23

95th Percentile 99th Percentile 99.9th Percentile

2.0 2.5 3.0

(2.5) (3.0) (--)

2.5 3.0 4.0

(3.0) (4.0) (--)

3.5

3.0

7.0

0.9617

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

2.0000

1.0000

0.5000

y = 0.3755x + 0.1463

R

2

 = 0.9617

Percentiles

Concentrations

EPA Novaluron (0.83 EC Formulation) Sorghum Grain, GRAIN 13-14 Days 0.232-0.239 lb ai/A

MANA/Chemtura
Novaluron Summary of Analytical Chemistry and Residue Data DP#: 374420

Page 23 of 24

Table I.3. Residue Data Used to Calculate Tolerance for Novaluron 

in/on Sorghum, Grain, Stover.

12.46

11.49

16.66

4.42

5.39

16.70

18.99

3.62

9.05

6.61

7.19

8.61

9.93

19.90

20.71

Figure I.5. Lognormal Probability Plot of Novaluron Field Trial Data for Sorghum, Grain, Stover.

Lognormal Probability Plot

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

26.0000

13.0000

6.5000

3.2500

y = 0.551x + 2.4037

R

2

 = 0.9761

Percentiles

Concentrations EPA Novaluron (0.83 EC Formulation) Sorghum Grain, STOVER--Adjusted to 88% dry matter

13-14 days 0.232-0.239 lb ai/A MANA/Chemtura
Novaluron Summary of Analytical Chemistry and Residue Data DP#: 374420

Page 24 of 24

Figure I.6. Tolerance Spreadsheet Summary of Novaluron Field Trial Data for Sorghum, Grain, Stover.

Regulator: EPA

Chemical: Novaluron (0.83 EC Formulation)

Crop: Sorghum Grain, STOVER--Adjusted to 88% dry matter

PHI: 13-14 days

App. Rate: 0.232-0.239 lb ai/A

Submitter: MANA/Chemtura

n: 22

min: 3.62

max: 25.96

median: 10.71

average: 12.58

95th Percentile 99th Percentile 99.9th Percentile

25 30 35

(30) (35) (--)

30 40 60

(40) (65) (--)

35

35

60

0.9761

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