Document ID: EPA-HQ-OPP-2007-0438-0007
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2008-12-10T05:00Z

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, D.C.  20460

OFFICE OF           

PREVENTION, PESTICIDES

AND TOXIC SUBSTANCES

MEMORANDUM

Date:		07-FEB-2008

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.

DP#s:	340137 & 342004	Decision #s:	379033 & 380280

PC Code:	124002	MRID #s:	46819601, 47094901, 

47180501 and 47180502

40 CFR §180.	598

Chemical Class:	benzoylphenyl urea

From:	George F. Kramer, Ph.D., Senior Chemist

	Registration Action Branch (RAB1)

		Health Effects Division (HED) (7509P)

Through:		P.V. Shah, Ph.D., Branch Senior Scientist

		RAB1/HED (7509P)

To:		Daniel Rosenblatt, PM Team 05

		Kable Davis/John Hebert, PM Team 07

		Registration Division (RD) (7505P)

This document was originally prepared under contract by Dynamac
Corporation (2275 Research Blvd, Suite 300; Rockville, MD 20850;
submitted 11/14/2007).  The document has been reviewed by HED and
revised to reflect current Office of Pesticide Programs (OPP) policies.

Executive Summary

Novaluron, a benzoylphenyl urea compound, is a pesticide chemical
belonging to the class of insecticides called insect-growth regulators
(IGR).  IGRs slowly kill the insects over a period of a few days by
disrupting the normal growth and development of immature insects. 
Novaluron acts as an insecticide mainly by ingestion, but has some
contact activity.  It is currently registered for uses on pome fruits,
Brassica head and stem vegetables, tuberous and corm vegetables, and
cotton.  The basic producer of novaluron is Makhteshim-Agan of North
America (MANA).  End-use products containing novaluron as the active
ingredient (a.i.) are formulated as an emulsifiable concentrate (EC),
suspension concentrate (SC), or water-dispersible granular (WDG).  These
formulations may be applied on registered food/feed crops as foliar
spray treatments using aerial and ground equipment.

Under PP#7E7199, the Interregional Research Project No. 4 (IR-4) on
behalf of the Agricultural Experiment Stations of CA, FL, LA, and TN
requests the establishment of permanent tolerances for residues of the
insecticide novaluron,
1-[3-chloro-4-(1,1,2-trifluoro-2-trifluoro-methoxyethoxy)phenyl]-3-(2,6-
difluorobenzoyl)urea, in/on the following raw agricultural and processed
commodities:

Tomato	0.40 ppm

Tomato, paste	0.80 ppm

Sugarcane, cane	0.50 ppm

Concurrently, IR-4 wishes to amend the product label for Rimon® 0.83 EC
Insecticide (EPA Reg. No. 66222-35), an EC formulation containing 9.3%
a.i. (0.83 lb/gal) novaluron to add new uses on tomato (field and
greenhouse) and sugarcane, and for Rimon® 10SC Insecticide (EPA Reg.
No. 66222-40), a SC (equivalent to a flowable concentrate; FlC)
formulation containing 10% a.i. (0.83 lb/gal) novaluron to add a new use
on greenhouse tomato.  Foliar applications are to be made at maximum
seasonal rates of 0.23 lb a.i./A for tomato (field- and
greenhouse-grown) and 0.39 lb a.i./A for sugarcane.  Applications may be
made using ground or aerial equipment.  The proposed preharvest
intervals (PHIs) are 2 days for tomato and 14 days for sugarcane. 

Separately, MANA, Inc. has submitted a request to amend the product
label for Rimon® 0.83 EC Insectide (EPA Reg. No. 66222-35) in order to
revise the registered use pattern for head and stem Brassica vegetables
(subgroup 5A) by increasing the maximum seasonal rate from 0.16 lb
a.i./A to 0.23 lb a.i./A, and by reducing the PHI from 14 to 7 days.

Tolerances have been established for residues of novaluron under 40 CFR
§180.598.  The tolerance expression is in terms of the insecticide
novaluron, per se.  Plant tolerances have been established for the raw
agricultural commodities (RACs) of cotton, Brassica head and stem
vegetables (subgroup 5A), pome fruit (group 11), and tuberous and corm
vegetables (subgroup 1C) at levels ranging from 0.05 to 30 ppm. 
Livestock tolerances have been established at 20 ppm (milk fat), 11 ppm
(fat of cattle, goat, hog, 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), or 0.01 ppm (meat and meat
byproducts of hog).  A time-limited tolerance, with an expiration date
of 12/31/09, is established in association with a Section 18 Emergency
Exemption for sugarcane at 0.15 ppm.

The nature of the residue in plants and livestock is understood based on
acceptable plant metabolism studies reflecting foliar uses on apples,
cabbage, cotton and potatoes, and livestock metabolism studies on goats
and hens.  HED has previously concluded that the residue of concern for
tolerance enforcement and risk assessment is novaluron per se in plants
and livestock.

There are adequate residue analytical methods for tolerance enforcement.
 For analysis of crop matrices for residues of novaluron per se, gas
chromatography/electron-capture detection (GC/ECD) and high-performance
liquid chromatography/ultraviolet (HPLC/UV) methods are available. 
These methods have undergone successful evaluation 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).  It
is, however, noted that a previous novaluron petition, PP#4E6834 (DP#
325183, 8/23/06, S. Levy), required an interference study or
confirmatory method as a condition for registration.  To date, this
requirement has not been fulfilled.  The GC/ECD enforcement method (or
similar versions of the method) was used for data-collection in the
analysis of samples collected from the crop field, field rotational, and
processing studies discussed in this document.  The method was
adequately validated in conjunction with the subject studies; the
validated limit of quantitation (LOQ) was 0.05 ppm for all matrices. 
Pending submission of the requested validation data, HED concludes that
the current enforcement methods are adequate to enforce the tolerances
associated with the current petition.

For analysis of livestock commodities for residues of novaluron, a
similar GC/ECD method and liquid chromatography (LC)/mass spectrometry
(MS)/MS method have undergone evaluation by the ACB/BEAD.  The LC/MS/MS
method has been forwarded to FDA for inclusion in PAM II, and the GC/ECD
method was submitted as a confirmatory method.

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 crop field trial,
field rotational crop, and processing studies addressed herein except
for wheat straw.  Previously submitted storage stability data indicate
novaluron is reasonably stable for at least 5-12 months under frozen
storage in/on apples, broccoli, cabbage, pears, potatoes, and tomatoes. 
In addition, concurrent storage stability data were submitted confirming
the stability of novaluron residues in/on tomatoes stored frozen for up
to 146 days, and demonstrating the stability of novaluron residues in
tomato processed commodities stored frozen for up to 121 days.

Adequate cattle feeding studies are available to support the livestock
dietary burdens resulting from the proposed uses; no new poultry or
swine feedstuffs are associated with the proposed use on sugarcane and
tomato.  Using the most recent guidance concerning revisions of
feedstuff percentages in Table 1 (October 2006) and constructing
reasonably balanced livestock diets, the livestock dietary burdens of
novaluron are 5.9 ppm for beef cattle, 2.3 ppm for dairy cattle, 0.12
ppm for poultry, and 0.09 ppm for swine.  The existing novaluron
tolerances are adequate to support the proposed new use on sugarcane,
for which there is a ruminant feedstuff (sugarcane molasses).

The submitted field trial data for sugarcane are adequate and will
support the establishment of a tolerance of 0.50 ppm for residues of
novaluron in/on sugarcane.  The submitted residue data for tomatoes are
adequate to support the requested use of the EC formulation on
field-grown tomatoes and of the FlC formulation on greenhouse-grown
tomatoes.  However, additional data are required to support the
requested use of the EC formulation on greenhouse-grown tomatoes.  The
submitted data show that maximum residues of novaluron from the outdoor
field trials in which tomatoes were harvested 1-2 days following foliar
treatments at 1x were 0.126 ppm in/on large-fruit variety tomatoes and
0.275 ppm in/on small-fruit variety tomatoes.  Maximum residues of
novaluron from the greenhouse trials in which tomatoes were harvested
1-2 days following foliar treatments at 1x were 0.200 ppm in/on
large-fruit variety tomatoes and 0.470 ppm in/on small-fruit variety
tomatoes.  The available data will support the establishment of a
tolerance of 1.0 ppm for residues of novaluron in/on tomato.

The submitted field trial data for cabbage are inadequate to support the
request to amend the use directions for Brassica head and stem
vegetables (subgroup 5A) because no data were submitted broccoli or
cauliflower, the other representative crops of subgroup 5A.  Maximum
residues of novaluron were 1.108 ppm in/on cabbage samples harvested 7
days following foliar treatment with the 0.83 lb/gal EC at 0.23 lb
a.i./A (1x).  The submitted data thus demonstrate that the established
tolerance for subgroup 5A (0.50 ppm) is not adequate to support the
proposed new use.  HED will determine the appropriate tolerance for
subgroup 5A when the requested data for broccoli or cauliflower are
submitted.

The submitted sugarcane processing data are inadequate because the study
has not demonstrated that residues of novaluron will not concentrate in
the processed commodities of sugarcane following processing of the RAC
treated at an appropriate exaggerated rate or at the theoretical maximum
concentration factors (11.8x for refined sugar or 20x for molasses).  In
the submitted processing study, residues of novaluron were below the
method LOQ in/on the RAC treated at 2x; residues in samples of molasses
and refined sugar, which were processed from 2x-treated sugarcane, were
also below the LOQ.  A new sugarcane processing study is required using
a minimum exaggerated application rate of 5x.  It is noted that
quantifiable residues of novaluron were obtained in several of the
respective field trials conducted at the 1x nominal field rate (0.39 lb
a.i./A).

The submitted tomato processing data are adequate to satisfy data
requirements.  The data indicate that residues of novaluron are not
likely to concentrate above the LOQ in purée, but may concentrate
slightly in paste.  The expected residues of novaluron resulting in
tomato paste with processing do not exceed the recommended tolerance for
tomato; therefore, no tolerances for tomato processed commodities are
needed.  

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.  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.

 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.

No Canadian or Mexican maximum residue limits (MRLs) have been
established for novaluron on the requested crops.  A Codex MRL (step
8/CXL) is established for novaluron (fat soluble) on tomato at 0.02 ppm.
 

  SEQ CHAPTER \h \r 1 Regulatory Recommendations and Residue Chemistry
Deficiencies

Pending submission of revised Sections B and F (see requirement under
Proposed Tolerances), there are no residue chemistry issues that would
preclude granting a conditional registration for the requested uses of
novaluron on sugarcane and tomatoes, or establishment of permanent
tolerances for novaluron residues as follows:  SEQ CHAPTER \h \r 1 

Sugarcane, cane	0.50 ppm

Tomato	1.0 ppm

Data pertaining to additional field trial and processing studies and
additional analytical method data and should be submitted before the
residue chemistry database will support an unconditional registration.

HED cannot favorably recommend for MANA’s request to revise the
registered use pattern for head and stem Brassica vegetables (subgroup
5A) until the requested data for broccoli or cauliflower are submitted
and evaluated.

A human-health risk assessment is forthcoming in a separate document.

Note to RD:  The preferred chemical name for novaluron is
N-[[[3-chloro-4-[1,1,2-trifluoro-2-(trifluoromethoxy)ethoxy]phenyl]amino
]carbonyl]-2,6-difluorobenzamide.  40 CFR §180.598 should be revised
accordingly.  It is also noted that 40 CFR 180.598 should be amended to
correct the commodity “Vegetables, tuberous and corn, subgroup 1C”
to “Vegetable, tuberous and corm, subgroup 1C.”

860.1200 Directions for Use (tomato and sugarcane)

The requested use for greenhouse-grown tomatoes on the EC formulation
label should be removed until additional residue data are provided to
support this use.  Also, a reapplication interval of at least 8 days
should be specified for sugarcane.

860.1340 Residue Analytical Methods

As initially requested in PP#4E6834 (DP# 325183, 8/23/06, S. Levy), an
interference study for the plant method is required to determine whether
other pesticides registered on the same commodities interfere with the
determination of novaluron; an interference study may be waived if a
specific single-analyte confirmatory method is submitted.  

860.1500 Crop Field Trials

For tomatoes, additional data are required to support the requested use
of EC formulation on greenhouse-grown tomatoes.  

To support the proposed amendment to the use directions for Brassica
head and stem vegetables (subgroup 5A), two additional field trials are
required for cabbage in Zones 1 and 5 (one each) and 6 trials are
required for broccoli or cauliflower in the recommended locations for
the chosen crop.  All field trials should reflect the proposed maximum
use pattern.  

860.1520 Processed Food and Feed

A sugarcane processing study conducted at an exaggerated rate (up to 5x)
is required in attempts to achieve quantifiable residues in the RAC and
to demonstrate the possible potential for concentration with processing.

860.1550 Proposed Tolerances

The proposed tolerance for tomato should be revised from 0.40 ppm to 1.0
ppm.

The proposed tolerance for tomato paste should be removed.

Background

  SEQ CHAPTER \h \r 1 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	

Common name	Novaluron

IUPAC name
1-[3-chloro-4-(1,1,2-trifluoro-2-trifluoromethoxyethoxy)phenyl]-3-[2,6-d
ifluorobenzoyl]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® 10SC Insecticide (0.83 lb/gal FlC; EPA
Reg. No. 66222-40)

Rimon® 0.83 EC 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, 11/3/2005, 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)	8.39 mg/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

A summary of the proposed use directions addressed in this document is
presented in Table 3.

IR-4 has submitted the proposed labels for Rimon® 0.83 EC Insecictide
(0.83 lb/gal EC; EPA Reg. No. 66222-35), adding new uses on tomato
(field and greenhouse) and sugarcane; and Rimon® 10SC Insecticide (0.83
lb/gal FlC; EPA Reg. No. 66222-40), adding uses on greenhouse tomato.

MANA has submitted a supplemental label for the Rimon® 0.83 EC
Insecticide (EPA Reg. No. 66222-35) to revise the registered use pattern
for head and stem Brassica vegetables by increasing the maximum seasonal
rate from 0.16 lb a.i./A to 0.23 lb a.i./A, and by reducing the PHI from
14 to 7 days.

Table 3.  Summary of Directions for Use of Novaluron.

Applic. Timing, Type, and Equip.	Formulation

[EPA Reg. No.]	Applic. Rate 

(lb a.i./A)	Max. No. Applic. per Season	Max. Seasonal Applic. Rate

(lb a.i./A)	PHI

(days)	Use Directions and Limitations

Head and Stem Brassica Vegetables

(including:  broccoli, Chinese broccoli, Brussels sprouts, cabbage,
cavalo broccolo, cauliflower, Chinese broccoli (gai loi), Chinese
cabbage (Napa), Chinese mustard (gai choy), and kohlrabi)

Foliar;

Ground/aerial	0.83 lb/gal EC

[66222-35]	0.039-0.078	3	0.23	7	Apply in a minimum of 10 gal/A (GPA) for
ground applications and 2 GPA for aerial applications.  Reapplication
may be made with a minimum 7-day interval.  

Sugarcane

Foliar;

Ground/aerial	0.83 lb/gal EC

[66222-35]	0.058-0.078	5	0.39	14	Apply in a minimum of 10 GPA using
ground equipment or 2 GPA using aerial equipment.  Repeat applications
when threshold levels are again exceeded.  Use of a non-ionic surfactant
is recommended.  No reapplication interval is specified.  

Tomato (field and greenhouse)

Foliar;

Ground/aerial	0.83 lb/gal EC

[66222-35]	0.058-0.078	3	0.23	2	Apply in a minimum of 10 GPA using
ground equipment or 2 GPA using aerial equipment.  Reapplication may be
made with a minimum 7-day interval.  

For greenhouses, use 9-12 oz (0.058-0.078 lb a.i.) in 100 gal/water. 

Tomato (greenhouse)

Foliar;

Ground	0.83 lb/gal FlC

[66222-40]	0.058-0.078	3	0.23	2	Direct to foliage using uniform spray
coverage (consult local agricultural specialist for spray volumes). 
Reapplication may be made with a minimum 7-day interval.  

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.  Rimon® may be applied alone, as a tankmix, or in
rotation with other registered insecticides.

Conclusions.  Provided a reapplication interval of at least 8 days is
specified for sugarcane, the proposed labels are adequate to allow
evaluation of the residue data relative to the proposed new uses on
sugarcane and tomatoes and the proposed amended use pattern for head and
stem Brassica vegetables (subgroup 5A).  However, the requested use for
greenhouse-grown tomatoes on the EC formulation label should be removed
until additional residue data are provided to support this use.  In
addition, HED cannot favorably recommend for MANA’s request to revise
the registered use pattern for head and stem Brassica vegetables
(subgroup 5A) until the requested residue data are submitted and
evaluated.

860.1300 Nature of the Residue - Plants

  SEQ CHAPTER \h \r 1 MARC Decision Memo, DP# 297646, 2/3/04, G.F.
Kramer

Residue Chemistry Memo, DP# 285474, 3/22/04, G.F. Kramer (PP#2F6430)

  SEQ CHAPTER \h \r 1 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-U-14C]novaluron and
[chlorophenyl-U-14C]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 (2/3/04) determined that the residue of concern in crops for
purposes of tolerance enforcement and risk assessment is novaluron per
se.

860.1300 Nature of the Residue - Livestock

  SEQ CHAPTER \h \r 1 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
livestock is adequately understood based on the submitted goat and
poultry metabolism studies with [difluorophenyl-U-14C]novaluron and/or
[chlorophenyl-U-14C]novaluron (goats only).  The studies indicate that
novaluron is primarily excreted and not extensively metabolized in
livestock.  A small amount of novaluron was metabolized in ruminants
yielding low levels of 2,6-difluorobenzoic acid in urine and kidney, and
1-[3-chloro-4-(1,1,2-trifluoro-2-trifluoromethoxyethoxy)phenyl]urea in
feces and liver.  The HED MARC (2/3/04) determined that the residue of
concern in livestock for purposes of tolerance enforcement and risk
assessment is novaluron per se.

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)

Plants

Enforcement Methods:    SEQ CHAPTER \h \r 1 MANA previously submitted
under PP#2F6430 a GC/ECD residue analytical method for the analysis of
residues of novaluron per se 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 a NH2-SPE
(solid-phase extraction) cartridge, the eluate is evaporated to dryness,
and residues are redissolved in ethyl acetate or hexane for analysis by
GC/ECD.  The validated LOQs are 0.01 ppm in potatoes and 0.05 ppm in
apples (including juice and wet pomace) and cabbage.

A second method, HPLC/UV, was submitted for the analysis of novaluron
residues per se in/on cotton commodities.  Similarly, samples are
extracted with 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 DP# 325183 for the GC/ECD method, and both
methods were forwarded to the EPA ACB for petition method validation
(PMV).  An interference study was required.

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 (DP# 306998). 
Both methods have been forwarded to FDA for inclusion in the PAM II as a
Letter Method (DP# 307595).

Data-collection:  Samples of cabbage, mustard greens, turnip, sugarcane,
tomato, and wheat matrices from the field trial and limited field
rotational crop studies and samples of sugarcane molasses and refined
oil, and tomato purée and paste from the processing studies were
analyzed for residues of novaluron per se using the GC/ECD method (with
minor modifications) previously proposed for enforcement purposes.

Adequate method verification and/or concurrent method recovery data were
provided for each of the subject matrices in conjunction with the
submitted field trial, limited field rotational crop and processing
studies.  Fortification levels in the method validation adequately
encompassed the expected residues in/on cabbage, sugarcane, tomato,
sugar cane molasses and refined sugar, tomato purée and paste, and
rotated turnip roots and wheat straw.  The fortification levels of the
concurrent method validation for mustard greens (primary crop) analyzed
in the field rotational crop study did not encompass observed residues,
but the available method validation data for cabbage will cover the
mustard greens residue levels.  The validated LOQ was 0.05 ppm for each
of the subject matrices.

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, or similar versions of this method, was used for
data collection in the crop field trial, field rotational crop, and
processing studies.  The method was adequately validated in conjunction
with the submitted cabbage, sugarcane and tomato field trial and
processing studies, and limited field rotational crop study associated
with the new and amended uses discussed herein.  An interference study
is still required to determine whether other pesticides registered on
the same commodities interfere with the determination of novaluron; an
interference study may be waived if a specific single-analyte
confirmatory method is submitted.  Pending submission of the requested
validation data, HED concludes that the current enforcement methods are
adequate to enforce the tolerances associated with the current petition.

Livestock

Enforcement Methods:   SEQ CHAPTER \h \r 1    SEQ CHAPTER \h \r 1 A
GC/ECD method, which is similar in principles to the GC/ECD method
submitted for plant commodities, was previously submitted for analysis
of residues of novaluron per se in livestock commodities (eggs, milk,
and ruminant tissues).  The validated LOQ is 0.01 ppm for fat, kidney,
liver, muscle, milk, and egg.  In addition, a HPLC/MS/MS method
(MAK/670-01R) was also previously submitted and proposed as the
enforcement method.

HPLC/MS/MS Method MAK/670-01R was successfully validated by an
independent laboratory using milk, muscle, and liver; the validated LOQs
were 0.02 ppm for milk and muscle, and 0.05 ppm for liver.  Acceptable
radiovalidation data using poultry tissues and eggs were submitted for
the GC/ECD method (DP# 325183); radiovalidation data were not required
for the HPLC/MS/MS method, as both methods use similar extraction and
cleanup procedures.  HED concluded that the LC/MS/MS method may be used
for tolerance enforcement with the GC/ECD method available as a
confirmatory method.  The methods were forwarded to ACB for laboratory
validation.

ACB concluded that based upon review of the submitted method validation
data, without laboratory validation, the GC/ECD and LC/MS/MS residue
analytical methods appear to be suitable for food tolerance enforcement
in bovine tissues (fat, kidney, liver, and muscle), milk, and eggs.  ACB
recommended that the analytical methods do not need to be laboratory
validated by EPA (DP# 306998).  The HPLC/MS/MS method was sent to FDA to
be published in PAM II as a Letter Method (DP# 307595).

860.1360 Multiresidue Methods

Residue Chemistry Memo, DP# 322359, 10/19/2005, S. Levy (PP#2F6430)

  SEQ CHAPTER \h \r 1 Novaluron was tested through the FDA MRM Test
guidelines in PAM I, Appendix II (1/94).  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

DER References:  47094901.de1.doc (tomato concurrent storage stability
data)

		 47094901.de2.doc (tomato processed matrices concurrent storage
stability data)

Residue Chemistry Memo, DP# 285474, 3/22/04, G.F. Kramer (PP#2F6430)

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 in apple juice for up to 3.3 months.

In conjunction with the subject tomato field trial and processing
studies, concurrent storage stability data were generated which further
demonstrate that fortified residues of novaluron are relatively stable
under frozen conditions in/on tomatoes for up to 146 days and in tomato
purée and paste for up to 121 days.  Although no 0-day data were
provided with the concurrent storage stability data, no additional data
will be required in consideration of the stability of novaluron in/on
other crop matrices.

The storage durations and conditions of samples from the crop field
trial, field rotational crop, and processing studies submitted to
support this petition are presented in Table 4.

Table 4.  Summary of Storage Conditions and Durations of Samples from
Crop Field Trial, Processing, and Field Rotational Crop Studies.  

Matrix 	Temperature

 (°C)	Actual Storage

Duration	Interval of Demonstrated Storage Stability

Cabbage, heads with wrapper leaves	<0	43-92 days

(1.4-3.0 months)	Residues of novaluron are relatively stable in/on
various crop matrices including cabbage stored frozen for up to 6
months.

Mustard greens (primary crop from rotational crop study)	<0	126 days 

(4.1 months)	Residues of novaluron are relatively stable in various crop
matrices including cabbage stored frozen for up to 6 months.

Sugarcane

(field trials)	<0	14-123 days 

(<1-4.0 months)	Residues of novaluron are relatively stable in/on
various crop matrices including apples, broccoli, cabbage, pears,
potatoes, and tomatoes stored frozen for 5-12 months.

Sugarcane

(processing study)	<0	114 days 

(3.7 months)

	Sugarcane, molasses	<0	10 days 

(<1.0 month) 	None required; analyzed within 30 days of collection.

Sugarcane, refined sugar	<0	10 days 

(<1.0 month)

	Tomato

(field trials)	<-5	16-145 days 

(<1–4.8 months)	Up to 146 days for residues of novaluron in/on frozen
tomatoes (concurrent storage stability data).

Tomato 

(processing study)	<-5	74-127 days 

(2.4 -4.2 months)

	Tomato, purée	<-5	28-119 days 

(<1.0-3.9 months)	Up to 121 days for residues of novaluron in/on frozen
tomato processed commodities (purée and paste; concurrent storage
stability data).

Tomato, paste	<-5	28-119 days 

(<1.0-3.9 months)

	Turnip, root 

(rotated crop)	<0	20 days 

(0.7 months)	Residues of novaluron are relatively stable in various crop
matrices including potato stored frozen for up to 12 months.

Wheat, straw

(rotated crop)	<0	64 days 

(2.1 months)	None available.

Conclusions.  The available storage stability data for apples, broccoli,
cabbage, pears, potatoes, and tomatoes are adequate to support the
storage conditions and durations of samples of cabbage, mustard greens,
sugarcane, and turnip roots from the crop field trial and field
rotational crop studies associated with this petition.  The concurrent
storage stability conducted with the tomato field trial and processing
studies will support the sample conditions and durations of tomato
fruit, purée and paste from those studies.  No supporting storage
stability data are required for the processed commodities of sugarcane,
as analyses were conducted within 30 days of collection or for wheat
straw as the field rotational crop study is not necessary to support the
proposed PBIs.

860.1480 Meat, Milk, Poultry, and Eggs

Residue Chemistry Memo, DP# 285474, 3/22/04, G.F. Kramer (PP#2F6430)

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

The only livestock feedstuff associated with the proposed new uses
addressed in this document is sugarcane molasses.  Using the most recent
guidance concerning revisions of feedstuff percentages in Table 1
(October 2006) and constructing reasonably balanced livestock diets, the
livestock dietary burdens of novaluron are presented in Table 5.  The
calculated dietary burdens of novaluron are 5.9 ppm for beef cattle, 2.3
ppm for dairy cattle, 0.12 ppm for poultry, and 0.09 ppm for swine.  The
dietary burdens for beef and dairy cattle using reasonably balance diets
were reduced from the maximum theoretical dietary burdens previously
calculated in PP# 2F6430.

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

Feedstuff	Type1	% Dry Matter2	% Diet2	Established/

Recommended Tolerance (ppm)	Dietary Contribution (ppm)3

Beef Cattle

Cotton, gin byproducts	R	90	5	30	1.7

Other R, not treated	R	--	15	--	0

Apple, wet pomace	CC	40	20	8.0	4.0

Sugarcane, molasses	CC	75	10	0.5	0.07

Other CC, not treated	CC	--	35	--	0

Cotton, undelinted seed	PC	88	15	0.60	0.10

TOTAL BURDEN	--	--	100	--	5.9

Dairy Cattle

Cotton, hulls	R	90	15	0.60	0.10

Other R, not treated	R	--	30	--	0

Apple, wet pomace	CC	40	10	8.0	2.0

Sugarcane, molasses	CC	75	10	0.5	0.07

Other CC, not treated	CC	--	20	--	0

Cotton, undelinted seed	PC	88	15	0.60	0.1

TOTAL BURDEN	--	--	100	--	2.3

Poultry

CC feedstuffs, not treated	CC	--	80	--	0

Cotton, meal	PC	--	20	0.60	0.12

TOTAL BURDEN	--	--	100	--	0.12

Swine

CC feedstuffs, not treated	CC	--	85	--	0

Cotton, meal	PC	--	15	0.60	0.09

TOTAL BURDEN	--	--	100	--	0.09

1  R:  Roughage; CC:  Carbohydrate concentrate; PC:  Protein
concentrate.

2  OPPTS 860.1000 Table 1 Feedstuffs (October 2006).  

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

An adequate ruminant feeding study with novaluron was previously
submitted and reviewed in PP#2F6430.  In the dairy cattle feeding study,
the dosing levels were 0.44, 3.9, 12.6, and 42.8 ppm.  These dosing
levels are equivalent to 0.1x, 0.7x, 2.1x, and 7.3x the recalculated
dietary burden of 5.9 ppm for beef cattle and 0.2x, 1.7x, 5.6x, and 19x
the recalculated burden of 2.3 ppm for dairy cattle (see Table 5).  A
summary of the residues of novaluron in dairy cattle matrices following
the oral administration of the test substance over the 42-44 consecutive
days is presented in Table 6.

Table 6.  Summary of Novaluron Residues in Dairy Cattle Matrices
Following the Oral Administration of the Test Substance at 0.44, 3.9,
12.6, and 42.8 ppm over 42-44 Consecutive Days.

Matrix	Maximum Novaluron Residue Levels (ppm) by Feeding Level

	0.44 mg/kg in diet	3.9 mg/kg in diet	12.6 mg/kg in diet	42.8 mg/kg in
diet

Whole milk	0.06	0.17	0.43	2.07

Cream	1.12	3.06	7.66	20.90

Skimmed milk	<0.01	0.02	0.04	0.14

Muscle	0.05	0.09	0.34	0.56

Kidney	0.06	0.14	0.35	1.20

Liver	0.05	0.14	0.41	1.36

Subcutaneous Fat	0.43	1.24	4.36	8.21

Peritoneal fat	0.56	2.25	6.83	12.89

Conclusions.  The addition of sugarcane molasses does not significantly
alter the dietary burdens of novaluron to ruminants, and the existing
tolerances for ruminant commodities will not be exceeded with the new
use on sugarcane.  There are no poultry feedstuffs associated with the
new proposed uses on sugarcane and tomatoes, and the dietary burden to
poultry did not change for registered uses of novaluron using a
reasonably balanced diet.

860.1500 Crop Field Trials

PP#7E7199

DER References:  46819601.de1.doc (sugarcane)

		 47094901.de1.doc (tomato)

Table 7.  Summary of Residue Data from Crop Field Trials with Novaluron.

Commodity	Total 

Applic. Rate

(lb a.i./A)	PHI (days)	Residue Levels (ppm)1

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

SUGARCANE (proposed use = 0.39 lb a.i./A total application rate, 14-day
PHI)

Sugarcane 	0.390-0.399	10-14	14	<0.05	0.311	0.293	0.071	0.125	0.098

TOMATO (field and greenhouse proposed use = 0.23 lb a.i./A total
application rate, 2-day PHI)

Field (Outdoor) Trials with 0.83 EC Treatment

Tomato fruit

(large-fruit variety)	0.237-0.248	1-2	24	<0.05	0.126	0.125	0.060	0.072
0.028

Tomato fruit 

(small-fruited variety)	0.239-0.242	1-2	6	0.190	0.275	0.270	0.250	0.243
0.031

Overall (small- & large-fruit varieties)	0.237-0.248	1-2	30	<0.05	0.275
0.270	0.065	0.107	0.075

Greenhouse Trials with 0.83 FlC Treatment

Tomato fruit

(large-fruit variety)	0.242-0.254	1-2	6	<0.05	0.200	0.170	0.057	0.092
0.063

Tomato fruit 

(small-fruited variety)	0.249	1	2	0.260	0.470	0.365	0.365	0.365	NA3

Overall (small- & large-fruit varieties)	0.242-0.254	1-2	8	<0.05	0.470
0.365	0.102	0.161	0.148

Side-by-side field trials comparing treatments of 0.83 EC with or
without crop oil concentrate (COC)

Tomato fruit (w/COC)	0.237-0.243	1-2	6	<0.05	0.230	0.210	0.079	0.113
0.078

Tomato fruit 

(w/o COC)	0.239-0.243	1-2	6	<0.05	0.200	0.180	0.055	0.095	0.067

1  For calculation of HAFT, median, mean and standard deviation, the LOQ
(0.05 ppm) was used for all residues reported as ND or below the LOQ.

2  HAFT = Highest-Average Field Trial.

3  NA = not applicable; standard deviation is applicable only for groups
of ≥3 samples.

Sugarcane

MANA, in co-sponsorship with Chemtura Corporation, submitted field trial
data for novaluron on sugarcane.  Eight field trials were conducted in
the U.S. in Zones 3 (FL; 3 trials), 4 (LA; 3 trials), 6 (TX; 1 trial),
and 13 (HI; 1 trial) during the 2005 growing season.  Crops at one of
the trials conducted in FL were destroyed by Hurricane Wilma; therefore,
data were only provided for 7 trials.

Each field trial consisted of one untreated plot and one treated plot. 
Five broadcast foliar applications of a 0.83 lb/gal EC formulation of
novaluron were made to sugarcane at ~0.078 lb a.i./A/application, with
8- to 12-day retreatment intervals, for a total application rate of
~0.39 lb a.i./A (1x the proposed maximum seasonal rate).  All
applications were made using ground equipment in 20-40 gal/acre spray
volumes, with an adjuvant (non-ionic surfactant) added to the spray
mixture.

Sugarcane samples were harvested 10-14 days after the last application. 
Additional samples were collected from 1 trial site 0, 7, 21, and 28
days following the last application to generate residue decline data.

The sugarcane samples were analyzed for residues of novaluron per se
using a GC/ECD method previously submitted as the enforcement method for
plants.  This method is adequate for data collection based on acceptable
method validation and concurrent method recoveries.  The reported limit
of detection (LOD) was 0.005 ppm, and the validated LOQ is 0.05 ppm for
sugarcane.

The sample storage conditions and durations are summarized in Table 4. 
Samples were stored frozen for a maximum of 123 days (4 months) from
harvest to analysis.  Sample storage conditions and durations are
supported by previously submitted storage stability data for various
crops.

The results of the sugarcane field trials are presented in Table 7.   
SEQ CHAPTER \h \r 1 Maximum residues of novaluron were 0.311 ppm in/on
sugarcane harvested 10-14 days following foliar treatments with the 0.83
lb/gal EC for a seasonal rate of 0.39-0.40 lb a.i./A.  Residue decline
data demonstrate that novaluron residues generally decreased in/on
sugarcane with increasing sampling intervals.

Conclusions.  Geographic representation of residue data submitted for
sugarcane is not in full compliance with the guideline.  According to
Table 1 of OPPTS 860.1500, a total of 8 field trials are required to
establish a tolerance for sugarcane; only 7 field trials were
successfully carried out as one FL trial was destroyed by a hurricane. 
However, an additional field trial will not be required as data from an
additional treated plot were submitted with the processing study. 
Novaluron residues were <LOQ at a 2X rate in this trial.  Samples from
the two trials conducted in Zone 3 were harvested early (10-day PHI
instead of the proposed 14-day PHI) because of an impending hurricane. 
Because the residue decline data for sugarcane showed a half-life of >28
days, the early harvest of these samples is not expected to
significantly impact the study results.

The field trial data for sugarcane 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 (0.50 ppm) for residues of novaluron in/on sugarcane.

Tomato

IR-4 submitted field trial data for novaluron on tomatoes.  Nineteen
tomato trials (15 field and 4 greenhouse) were conducted in the U.S. and
Canada on tomatoes in Zones 1 (NY; 1 trial), 2 (NC and NJ; 2 trials), 3
(FL; 2 trials), 5 (ON and WI; 2 trials), 6 (TX; 1 trial), 8 (CO; 1
trial), and 10 (CA and NM; 10 trials) during the 2004 growing season. 
Small-fruited varieties were included in both the greenhouse (n=1) and
outdoor (n=3) field trials.

Each trial site consisted of one untreated plot and one treated plot. 
Tomatoes were treated with three broadcast/directed foliar applications
at ~0.08 lb a.i./A/application, with 6- to 9-day retreatment intervals,
for a total application rate of ~0.24 lb a.i./A (1x the proposed maximum
seasonal rate).  Applications were made at the field trial sites using
the 0.83 lb/gal EC formulation of novaluron, while the 0.83 lb/gal SC
(equivalent to a FlC) formulation of novaluron was used for the
greenhouse trials; all applications were made using ground equipment in
24-100 gal/acre with an adjuvant (COC) added to the spray mixture.  No
adjuvant was added for the first two applications at one field trial and
for all applications at the greenhouse trials.  

Three of the field trials included a second treated plot, in which
applications were made with the same rates and manner, but without COC
added to the spray mixture to compare results with and without the
addition of the adjuvant.  Mature tomatoes were harvested from all plots
1-2 days after the last application.

Samples of tomato were analyzed for residues of novaluron per se using a
GC/ECD method similar to the previously submitted enforcement method for
plants.  This method is adequate for data collection based on acceptable
method validation and concurrent method recoveries.  The lowest level of
method validation (LLMV) was 0.05 ppm.  The calculated LOD and LOQ were
0.026 and 0.077 ppm, respectively, for tomato.

The sample storage conditions and durations are summarized in Table 4. 
Samples were stored frozen for a maximum of 145 days (4.8 months) from
harvest to analysis.  The sample storage conditions and durations for
tomato samples are supported by concurrent storage stability data
conducted with the study.

The results of the tomato field trials are presented in Table 7.    SEQ
CHAPTER \h \r 1 Maximum residues of novaluron from the field trials in
which tomatoes were harvested 1-2 days following foliar treatment with
the 0.83 lb/gal EC for a total rate of 0.237-0.248 lb a.i./A, were 0.126
ppm in/on large-fruit variety tomatoes and 0.275 ppm in/on small-fruit
variety tomatoes; overall maximum residues were 0.275 ppm in/on tomatoes
from the field (outdoor) trials.

Maximum residues of novaluron from the greenhouse trials in which
tomatoes were harvested 1-2 days following foliar treatment with the
0.83 lb/gal FlC for a total rate of 0.242-0.254 lb a.i./A, were 0.200
ppm in/on large-fruit variety tomatoes and 0.470 ppm in/on small-fruit
variety tomatoes; overall maximum residues were 0.470 ppm in/on tomatoes
from the greenhouse trials.

As expected, novaluron residues in/on small-fruit variety tomatoes were
typically higher than those in the large-fruit varieties, and residues
in/on greenhouse-grown tomatoes were typically higher than those in/on
field-grown tomatoes.  The results of the side-by-side trials with and
without COC added to the application sprays, demonstrate that similar
residues were observed in/on tomatoes treated with the adjuvant. 
Residues of novaluron averaged 0.078 and 0.067 ppm in/on tomatoes
treated with or without the COC, respectively.

Conclusions.  Geographic representation of the submitted residue data
for tomato is adequate.  There are sufficient data to support the
requested use of the EC formulation on field-grown tomatoes and of FlC
formulation on greenhouse-grown tomatoes.  However, additional data are
required to support the requested use of the EC formulation on
greenhouse-grown tomatoes.

The available field trial data for field- and greenhouse-grown tomatoes
were separately 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 recommended tolerance is 0.45 ppm for field-grown
tomatoes and 1.0 ppm for greenhouse-grown tomatoes; therefore, the
higher tolerance of 1.0 ppm is recommended for novaluron on tomato.  A
revised Section F is requested to increase the proposed tolerance for
tomato from 0.40 ppm to 1.0 ppm.

Amended Uses

DER Reference:  47180501.der.doc (cabbage)

The petitioner has proposed to amend the product label for Rimon® 0.83
EC Insectide in order to increase the maximum seasonal rate from 0.16 lb
a.i./A to 0.23 lb a.i./A and to reduce the PHI from 14 to 7 days for
Brassica head and stem vegetables, subgroup 5A.

Table 8.  Summary of Residue Data from Crop Field Trials with Novaluron.

Commodity	Total Applic. Rate 

(lb a.i./A)	PHI

(days)	Residues (ppm)

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

BRASSICA HEAD & STEM, SUBGROUP 5A (proposed use = 0.23 lb a.i./A total
application rate, 7-day PHI) 

Cabbage heads

w/wrapper leaves	0.231-0.233

with COC	7	8	0.063	1.108	1.045	0.321	0.471	0.396

	0.230-0.232

w/out COC	7	8	0.067	0.931	0.864	0.216	0.359	0.328

1  HAFT = Highest-Average Field Trial.

Brassica head and stem, subgroup 5A (cabbage)

MANA, Inc. has submitted a field trial study sponsored by Chemtura
Corporation for novaluron on cabbage.  Four field trials were conducted
in the U. S. in EPA Zones 3 (FL; 1 trial), 6 (TX; 1 trial) and 10 (CA; 2
trials) during the 2004 growing season.

Each field trial consisted of one untreated plot and two treated plots. 
Each treated plot received three broadcast foliar applications of a 0.83
lb/gal 10EC formulation of novaluron, with 13- to 14-day retreatment
intervals, at ~0.08 lb a.i./A/application for a total application rate
of ~0.24 lb a.i./A (1x the proposed maximum seasonal rate). 
Applications to one treated plot were made with a 0.25% COC, while the
second treated plot did not include use of the COC.  Applications were
made using ground equipment in ~20-21 gal/A spray volumes.  Mature
cabbage heads were harvested 7 days after the last application (the
proposed PHI).

The cabbage samples were analyzed for residues of novaluron per se using
a GC/ECD method previously submitted as the enforcement method for
plants.  This method is adequate for data collection based on acceptable
method validation and concurrent method recoveries.  The validated LOQ
is 0.05 ppm for cabbage.  

The sample storage conditions and durations are summarized in Table 4. 
Samples were stored frozen for a maximum of 92 days (3 months) from
harvest to analysis.  The sample storage conditions and durations are
supported by previously submitted storage stability data for cabbage.

The results of the cabbage field trials are presented in Table 8. 
Maximum residues of novaluron were 1.108 ppm in/on cabbage (head with
wrapper leaves) samples harvested 7 days following foliar treatment with
the 0.83 lb/gal EC with COC at 0.23 lb a.i./A (1x).  Following foliar
treatment without the COC, maximum residues of novaluron were 0.931 ppm
in/on cabbage samples.  The data indicate that cabbage samples treated
with novaluron with a COC in the spray mixture result in slightly higher
residues than cabbage samples treated with novaluron without the COC in
the spray mixture.

Conclusions.  Geographic representation of residue data submitted for
Brassica head and stem vegetables, subgroup 5A is not in compliance with
the guidelines.  According to Table 3 of OPPTS 860.1500, a total of 6
field trials are required for cabbage, and 6 field trials are required
for broccoli or cauliflower as the representative crops of the Brassica
head and stem vegetables, subgroup 5A; only 4 cabbage field trials were
conducted.  Although the cabbage field trial data reflect the amended
use on Brassica head and stem vegetables, subgroup 5A, two additional
field trials are required for cabbage in Zones 1 and 5 (one each) and 6
trials are required for broccoli or cauliflower in the recommended
locations for the chosen crop; all field trials should reflect the
proposed maximum amended use pattern for novaluron on Brassica head and
stem vegetables, subgroup 5A.

The submitted data demonstrate that the established tolerance for
subgroup 5A (0.50 ppm) is not adequate to support the proposed new use. 
HED will determine the appropriate tolerance for subgroup 5A when the
requested data for broccoli or cauliflower are submitted.

860.1520 Processed Food and Feed

DER References:  46819601.de2.doc (sugarcane)

		 47094901.de2.doc (tomato)

Sugarcane

MANA, in co-sponsorship with Chemtura Corporation, submitted a
processing study for novaluron on sugarcane.  In one trial conducted in
LA, sugarcane was harvested 14 days after the last of five broadcast
foliar applications of a 0.83 lb/gal EC formulation of novaluron, at
~0.16 lb a.i./A/application with 9- to 11-day retreatment intervals, for
a total seasonal rate of 0.79 lb a.i./A (~2x the proposed maximum
seasonal rate).  Harvested sugarcane samples were processed into
molasses and refined sugar using commercial processing procedures.

Samples of sugarcane and its processed commodities were analyzed for
residues of novaluron per se using a GC/ECD method previously submitted
as the enforcement method for plants.  This method is adequate for data
collection based on acceptable concurrent method recoveries.  The
reported LOD was 0.005 ppm and the validated LOQ is 0.05 ppm for
sugarcane, molasses and refined sugar.

The sample storage conditions and durations are summarized in Table 4. 
Samples were stored frozen from harvest/collection to analysis for a
maximum of 114 days (3.7 months) for sugarcane, and 10 days for molasses
and refined sugar.  The sample storage conditions and durations for the
RAC are supported by previously submitted storage stability data for
various crops.  No supporting storage stability data will be required
for the processed commodities because they were analyzed within <30 days
after processing.

Residues of novaluron were less than the LOQ (<0.05 ppm) in/on sugarcane
(RAC) harvested 14 days after foliar treatment with the 0.83 lb/gal EC
for a total rate of 0.791 lb a.i./A.  Processing factors for molasses
and refined sugar could not be calculated because residues of novaluron
were below the method LOQ (<0.05 ppm) in/on both the RAC and the
processed commodities. 

According to Tables 3 and 4 of OPPTS 860.1520, the theoretical
concentration factor for refined sugar is 11.8x and the maximum observed
(experimental) concentration factor for molasses is 20x.  

Tomato

IR-4 has submitted a processing study with tomato.  In two trials
conducted in CA and NY, tomatoes were harvested 1 day after the last of
three broadcast foliar applications of the 0.83 lb/gal EC formulation of
novaluron, at ~0.08 lb a.i./A/application, with 6- to 9-day retreatment
intervals, for a total application rate of ~0.24 lb a.i./A (1x the
maximum proposed seasonal rate).  Harvested tomato samples were
processed into purée and paste using commercial processing procedures.

Samples of tomato and its processed commodities were analyzed for
residues of novaluron per se using a GC/ECD method similar to the
previously submitted enforcement method for plants.  This method is
adequate for data collection based on acceptable concurrent method
recoveries.  It is noted that a minor modification of the method was
used for analysis of the paste samples from one of the studies (NY) to
improve recoveries at the LLMV.  The calculated LOD and LOQ were,
respectively, 0.026 and 0.077 ppm in/on samples of tomatoes (RAC), 0.013
and 0.038 ppm in/on tomato purée, and 0.009 and 0.026 ppm in/on tomato
paste; the LLMV was 0.05 ppm for tomato, purée and paste.

The sample storage conditions and durations are summarized in Table 4. 
Samples were stored frozen from harvest/collection to analysis for a
maximum of 127 days (4.2 months) for tomato, and 119 days (3.9 months)
for tomato purée and paste.  The sample storage conditions and
durations for the RAC and processed commodities are supported by
concurrent storage stability data conducted with the study.

Residues of novaluron were 0.068 ppm in/on tomato fruit (RAC) from the
CA trial and below the LLMV (<0.05 ppm) in/on tomato fruit (RAC) from
the NY trial harvested 1 day following foliar treatment with the 0.83
lb/gal EC for a total rate of 0.25 lb a.i./A.  Based on the residues in
the processed commodities, residues of novaluron appear to concentrate
slightly in paste (1.1x processing factor from the CA trial), but do not
appear to concentrate in purée (<0.7x processing factor from the CA
trial).  A reliable processing factor for purée from the NY trial could
not be calculated because residues were below the LLMV in/on both the
RAC and processed purée. 

According to Table 2 of OPPTS 860.1520, the theoretical concentration
factor is 5.5x for tomato paste and 1.4x.for tomato purée; the observed
processing factors did not exceed the theoretical concentration factors.

The processing factors for novaluron in sugarcane and tomato are
summarized in Table 9.  

  SEQ CHAPTER \h \r 1 Table 9.  Summary of Processing Factors for
Novaluron.

RAC	Processed Commodity	Processing Factor

Sugarcane	molasses	NC1

	refined sugar	NC1

Tomato2	Purée	<0.7x

	Paste	1.1x

1 NC = not calculated because residues were below the method LOQ in both
the RAC and processed commodity.

2 Data from trial in which RAC bore quantifiable residues.

Conclusions.  The submitted tomato processing data are adequate to
satisfy data requirements.  The data indicate that residues of novaluron
are not likely to concentrate in purée, but may concentrate slightly in
paste.  Based on the processing factor (1.1x) for paste and the HAFT of
0.365 ppm from the tomato field and greenhouse trials (greenhouse tomato
trials yielded the highest HAFT), expected residues in tomato paste
would be 0.40 ppm.  The expected residues of novaluron resulting in
tomato paste with processing (0.40 ppm) do not exceed the recommended
tolerance for tomato RAC (1.0 ppm); therefore, no tolerances for tomato
processed commodities are needed.  A revised Section F should be
submitted to remove the proposed tolerance on tomato paste.  

The submitted sugarcane processing data are inadequate because the study
has not convincingly demonstrated that residues of novaluron will not
concentrate (and tolerances not needed) in the processed commodities of
sugarcane following processing of the RAC treated at an appropriate
exaggerated rate or at the theoretical maximum concentration factors
(11.8x for refined sugar or 20x for molasses).  In the submitted
processing study, residues of novaluron were below the method LOQ in/on
the RAC treated at 2x; residues in samples of molasses and refined
sugar, which were processed from 2x-treated sugarcane, were also below
the LOQ.  A new sugarcane processing study is required using a minimum
exaggerated application rate of 5x.  It is noted that quantifiable
residues of novaluron were obtained in several of the respective field
trials conducted at the 1x nominal field rate (0.39 lb a.i./A).

  SEQ CHAPTER \h \r 1 860.1650 Submittal of Analytical Reference
Standards

An analytical standard for novaluron is currently available in the EPA
National Pesticide Standards Repository (personal communication with
Dallas Wright, ACB, 10/04/07).  

860.1850 Confined Accumulation in Rotational Crops

Residue Chemistry Memo,DP# 285474, 3/22/04, G.F. Kramer (PP#2F6430)

  SEQ CHAPTER \h \r 1 In a previously submitted confined rotational crop
study (PP#2F6430), the test substance was applied at only 0.3x the
maximum proposed seasonal rate for rotatable crops (cotton and potato). 
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 TRR was <0.005 ppm in
all of the rotated crop commodities, it is unlikely that significant
residues would be present at 1x.  HED thus concluded that the results of
the study were applicable to that petition.  Because the maximum
proposed use for tomato and proposed amended use for Brassica head &
stem, subgroup 5A, which each may be rotated, is less than that for
cotton the results of the available confined rotational crop study will
also be considered applicable to the subject petition/label amendment.

The available confined rotational crop study is adequate to satisfy the
confined rotational crop data requirements.  MARC concluded that for
tolerance assessment and risk assessment, parent only is the residue of
concern.  A confined rotational crop study conducted with
[difluorophenyl-14C(U)]novaluron will not be required as the
difluorophenyl-derived metabolites are expected to be significantly less
toxic than the chlorophenyl metabolites.  However, future uses that have
significantly higher application rates will require confined rotational
crop studies at higher rates using chlorophenyl-labeled novaluron.  

Based on the results of the confined rotational crop study,, the
appropriate PBI for all non-labeled crops is 30 days.  The current and
proposed labels include restriction that only registered crops may be
rotated to a treated field within 30 days of the final application.

860.1900 Field Accumulation in Rotational Crops

DER Reference:  47180502.der.doc

Residue Chemistry Memo,DP# 285474, 3/22/04, G.F. Kramer (PP#2F6430)

Previously, HED concluded that if the   SEQ CHAPTER \h \r 1 label
indicates that only registered crops may be rotated to a treated field
within 30 days of the final application, a field accumulation study
would not be required for those petitions.  However, in association with
the proposed amended use for Brassica head and stem, subgroup 5A, MANA
has submitted the results of a field rotational crop study for
novaluron.

A single field rotational crop trial was conducted in the U.S. in Zone 6
(TX) during the 2004-2005 growing season.  Three foliar broadcast
applications of the 0.83 lb/gal EC formulation of novaluron were made to
the primary crop, mustard greens, at a target rate of 0.08 lb
a.i./A/application, with 14-day retreatment intervals, for a total
application rate of ~0.24 lb a.i./A.   Mustard greens were harvested
(and collected for analysis) 7 days after the last application and the
remainder of the primary crop was destroyed by disking the plot.  The
ground was prepared for planting according to area-typical agricultural
practices and the rotational crops, turnips and wheat, were planted at
29-, 57-, and 89-day PBIs.

Samples of turnip root were collected at maturity (88-151 days after
planting; DAP) and samples of wheat straw were collected at the early to
mature growth stage (162-207 DAP); these were the only RACs of rotated
turnip and wheat collected.

Samples of the rotated crops (turnip roots and wheat straw) as well as
the primary crop (mustard greens) were analyzed for residues of
novaluron using a GC/ECD method previously submitted as the enforcement
method for plants.  This method is adequate for data collection based on
acceptable concurrent method recoveries.  It is noted, however, that the
fortification levels of the validation samples did not encompass the
residues quantitated in/on the primary crop.  The reported LOD was 0.005
ppm and the validated LOQ is 0.05 ppm for all matrices.

The sample storage conditions and durations are summarized in Table 4. 
Samples were stored frozen from harvest/collection to analysis for a
maximum of 126 days (4.1 months) for mustard greens, 20 days (0.7
months) for turnip root, and 64 days (2.1 months) for wheat straw.  The
sample storage conditions and durations for mustard greens and turnip
roots are supported by previously submitted storage stability data for
various crops including cabbage and potato.  No storage stability data
are available for a similar field/grain crop to support the storage
duration of the wheat straw samples from the field rotational crop
study. 

The maximum residue of novaluron was 1.796 ppm in/on the primary crop,
mustard greens, harvested 7 days after foliar treatment with the 0.83 lb
a.i./gal EC for a total rate of 0.23 lb a.i./A.  Residues of novaluron
were below the LOQ (<0.05 ppm) in all rotated turnip root and wheat
straw samples from the 29-, 57-, and 89-day PBIs.

s 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 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 for tolerance enforcement
in plant and livestock commodities is novaluron per se.  The proposed
tolerance expression is adequate; however, the Section F for PP#7E7199
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-d
ifluorobenzoyl)urea.”  A revised Section F should be submitted to
remove the word combined and cite the appropriate CAS name for
novaluron,
“N-[[[3-chloro-4-[1,1,2-trifluoro-2-(trifluoromethoxy)ethoxy]phenyl]am
ino]carbonyl]-2,6-difluorobenzamide.”  HED also notes that the
chemical name under 40 CFR 180.598 should be amended as well.

It is also noted that 40 CFR 180.598 should be amended to correct the
commodity “Vegetables, tuberous and corn, subgroup 1C” to
“Vegetable, tuberous and corm, subgroup 1C.”

The available field trial data for sugarcane and tomato were entered
into the Agency’s tolerance spreadsheet (using maximum likelihood
estimation (MLE) procedures to impute censored values) as specified by
the Guidance for Setting Pesticide Tolerances Based on Field Trial Data
SOP to determine appropriate tolerance levels; see Appendix I.  The
tolerance spreadsheet recommends tolerances of 0.50 ppm for sugarcane,
0.45 ppm for field-grown tomatoes and 1.0 ppm for greenhouse-grown
tomatoes; the higher tolerance of 1.0 ppm will be appropriate as the
interim tolerance for tomato.  A revised Section F is required to
increase the proposed tolerance for tomato from 0.40 ppm to 1.0 ppm.

The submitted field trial data for cabbage are inadequate to support the
request to amend the use directions for Brassica head and stem
vegetables (subgroup 5A) because no data were submitted for broccoli or
cauliflower, the other representative crops of subgroup 5A.  The
submitted data demonstrate that the established tolerance for subgroup
5A (0.50 ppm) is not adequate to support the proposed new use.  HED will
determine the appropriate tolerance for subgroup 5A when the requested
data for broccoli or cauliflower are submitted.

The submitted sugarcane processing data are inadequate because the study
has not convincingly demonstrated that residues of novaluron will not
concentrate (and tolerances not needed) in the processed commodities of
sugarcane following processing of the RAC treated at an appropriate
exaggerated rate or at the theoretical maximum concentration factors
(11.8x for refined sugar or 20x for molasses).  In the submitted
processing study, residues of novaluron were below the method LOQ in/on
the RAC treated at 2x; residues in samples of molasses and refined
sugar, which were processed from 2x-treated sugarcane, were also below
the LOQ.  A new sugarcane processing study is required using a minimum
exaggerated application rate of 5x.  It is noted that quantifiable
residues of novaluron were obtained in several of the respective field
trials conducted at the 1x nominal field rate (0.39 lb a.i./A).

The submitted tomato processing data are adequate to satisfy data
requirements.  The data indicate that residues of novaluron are not
likely to concentrate above the LOQ in purée, but may concentrate
slightly in paste.  The expected residues of novaluron resulting in
tomato paste with processing do not exceed the recommended tolerance for
tomato RAC; therefore, no tolerances for tomato processed commodities
are needed.  

The existing livestock tolerances for novaluron are adequate to support
the new uses on sugarcane.  Sugarcane molasses is the only livestock
feedstuff associated with this petition, and the dietary burdens are not
expected to significantly increase with the addition of this commodity.

No Canadian or Mexican MRLs have been established for novaluron on the
requested crops.  A Codex (step 8/CXL) is established for novaluron (fat
soluble) on tomato at 0.02 ppm.  

A summary of the recommended tolerances for the current petition is
presented in Table 10.  The proposed tolerances should be revised to
reflect the recommended tolerance levels and correct commodity
definitions as specified in Table 10.  

Table 10.  Tolerance Summary for Novaluron.

Commodity	Established

Tolerance 

(ppm)	Proposed

Tolerance

(ppm)	Recommended 

Tolerance

(ppm)	Comments; 

Correct Commodity Definition

Brassica, head and stem, subgroup 5A	0.50	--	TBD	Additional field trial
data must be submitted before the tolerance level can be reassessed for
an increased use rate and shorter PHI.

Tomato	--	0.40	1.0

	Tomato, paste	--	0.80	Remove	Not needed; residues will be covered by
the RAC tolerance

Sugarcane, cane	0.15

(Section 18)	0.50	0.50

	

References

  SEQ CHAPTER \h \r 1 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

MRIDs:	None

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

MRIDs:	45638226-27, 45638301-08, 45638311-12, 45638412, 45638420,
45771801-03, 45785804, 45789202, 46141001, 46082701 and 46185801

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

MRIDs:	45638304-06 and 45638308

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

MRIDs:	46257301 and 46512101

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

MRIDs:	46714901 and 46714902

  SEQ CHAPTER \h \r 1 Attachments:  

International Residue Limit Status sheet

Appendix I - Tolerance Assessment Calculations

cc:  G. Kramer (RAB1)

RDI:  RAB1 Chemists (12/19/07)

G.F. Kramer:S10781:PY-S:(703)305-5079:7509P:RAB1

Template Version September 2005



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:  10/04/07

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
Number:  PP#7E7199

DP#:  340137

Other Identifier: Decision # 379033  

Residue definition (step 8/CXL): novaluron (fat soluble)
Reviewer/Branch:  G. Kramer/RAB1

	Residue definition:  Novaluron per se

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

Tomato	0.02 (*)	Tomato	0.40

Tomato, paste	0.80

Sugarcane, cane	0.50

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)

	Notes/Special Instructions:  S. Funk, 10/16/2007.

Appendix I.  Tolerance-Assessment Calculations.

Sugarcane

The dataset used to establish a tolerance for novaluron on sugarcane
consisted of field trial data representing application rates of
0.39-0.40 lb a.i./A (5 applications at ~0.78 lb a.i./A/application) with
a 10- to 14-day PHI.  As specified by the Guidance for Setting Pesticide
Tolerances Based on Field Trial Data SOP, the field trial application
rates are within 25% of the maximum label application rate and the PHIs
reflected the minimum label PHI, except for two trials in which samples
were harvested early (10-day PHI) due to an impending hurricane. 
Because the residue decline data for sugarcane showed a half-life of >28
days, the early harvest of these samples is not expected to
significantly impact the study results.  The residues values used to
calculate the tolerance are provided in Table I-1.

Because 3 of 14 field trial sample results were below LOQ (LOQ = 0.05
ppm), maximum likelihood estimation (MLE) procedures were needed to
impute censored values. 

The novaluron-sugarcane dataset was entered into the tolerance
spreadsheet.  Visual inspection of the lognormal probability plot
(Figure I-1) provided in the spreadsheet indicates that the dataset is
reasonably lognormal.  The result from the approximate Shapiro-Francia
test statistic (Figure I-2) confirmed that the assumption of
lognormality should not be rejected.  

Since the field trial data for novaluron on sugarcane represent a small
dataset (i.e., less than 15 samples) and are reasonably lognormal, the
upper bound estimate of the 95th percentile based on the median residue
value was compared to the minimum of the 95% upper confidence limit
(UCL) on the 95th percentile and the point estimate of the 99th
percentile, and the minimum value was selected as the tolerance value. 
Using the rounding procedure as outlined in the Guidance for Setting
Pesticide Tolerances Based on Field Trial Data SOP, the 95% UCL on the
95th percentile rounds to the value 0.50 ppm (Figure I-2).  The
recommended tolerance level for novaluron on sugarcane is 0.50 ppm.

Table I-1.	Residue data used to calculate tolerance for novaluron on
sugarcane.

Regulator:	EPA

Chemical:	Novaluron

Crop:	Sugarcane (MLE)

PHI:	10-14 Days

App. Rate:	0.39-0.40 lb a.i./A

Submitter:	MANA

MRID Citation:	MRID 46819601

	Residues of Novaluron (ppm)

	0.2740

	0.3110

	0.2120

	0.2850

	0.0681

	0.0838

	0.0252

	0.0676

	0.0615

	0.0674

	0.0342

	0.0422

	0.0745

	0.0960

Figure I-   SEQ Figure_II- \* ARABIC  1 .  Lognormal probability plot of
Novaluron field trial data for Sugarcane.

Figure I- 2.  Tolerance spreadsheet summary of Novaluron field trial
data for Sugarcane.

Tomato

The dataset used to establish a tolerance for novaluron on tomatoes
consisted of field trial data representing application rates of
0.24-0.25 lb a.i./A (3 applications at ~0.8 lb a.i./A/application) with
a 1- to 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 datasets were separated for
field-grown and greenhouse-grown tomatoes; the residues values used to
calculate the tolerance are provided in Table I-2.

Because 8 of 30 field trial sample results and 3 of 8 greenhouse trial
sample results were below the LOQ (LOQ = 0.05 ppm), MLE procedures were
needed to impute censored values. 

The novaluron-tomato datasets were entered into the tolerance
spreadsheet.  Visual inspection of the lognormal probability plot
(Figures I-3 and I-5) provided in the spreadsheet indicates that the
datasets are reasonably lognormal.  The result from the approximate
Shapiro-Francia test statistic (Figures I-4 and I-6) confirmed that the
assumption of lognormality should not be rejected.  

Since the field trial data for novaluron on tomato 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
Guidance for Setting Pesticide Tolerances Based on Field Trial Data 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-4).  

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1imit (UCL) on the 95th percentile and the point estimate of the 99th
percentile, and the minimum value was selected as the tolerance value. 
Using the rounding procedure as outlined in the Guidance for Setting
Pesticide Tolerances Based on Field Trial Data SOP, the 95% UCL on the
95th percentile rounds to the value 1.0 ppm (Figure I-6). 

The recommended tolerance is 0.45 ppm for field-grown tomatoes and 1.0
ppm for greenhouse-grown tomatoes, therefore, the higher tolerance of
1.0 ppm is recommended for novaluron on tomato.

Table I-2.  Residue data used to calculate tolerance for novaluron on
tomato.

Regulator:	EPA

Chemical:	Novaluron

Crop:	Tomato(MLE)

PHI:	1-2 Days

App. Rate:	0.24-0.25 lb a.i./A

Submitter:	IR-4

MRID Citation:	MRID 47094901

	Residues of Novaluron (ppm)

	Field-grown tomatoes	Greenhouse-grown Tomatoes

	0.0182	0.0157

	0.0233	0.0260

	0.0650	0.1400

	0.0800	0.2000

	0.0273	0.0371

	0.0600	0.0640

	0.1900	0.2600

	0.2300	0.4700

	0.1240

0.1260

0.0500

0.1000

0.2400

0.2600

0.0343

0.0640

0.2650

0.2750

0.0580

0.1000

0.0375

0.0406

0.0580

0.0840

0.0600

0.0650

0.1180

0.1250

0.0437

0.0469

	

Figure I- 3.  Lognormal probability plot of Novaluron field trial data
for Field-grown Tomato.

Figure I-4.  Tolerance spreadsheet summary of Novaluron field trial
data for Field-grown Tomato.

Figure I- 5.  Lognormal probability plot of Novaluron field trial data
for Greenhouse-grown Tomato.

Figure I-6.  Tolerance spreadsheet summary of Novaluron field trial
data for Greenhouse-grown Tomato.

Novaluron	Summary of Analytical Chemistry and Residue Data	DP# 340137 &
342004

Page   PAGE  28  of   NUMPAGES  34