Document ID: EPA-HQ-OPP-2009-0273-0006
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2010-01-27T05:00Z

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, D.C.  20460

	OFFICE OF PREVENTION, PESTICIDES,

	AND TOXIC SUBSTANCES

  SEQ CHAPTER \h \r 1 MEMORANDUM

Date:		04-DEC-2009

SUBJECT:	Novaluron.  Petition for the Establishment of Permanent
Tolerances for Residues of Novaluron in/on Vegetable, Fruiting, Group 8;
Vegetable, Cucurbit, Group 9; Berry, Low-growing, Subgroup 13-07G;
Miscellaneous Fruiting Vegetables; Bean, Snap; Bean, Dry, Seed; and
Swiss Chard.  Summary of Analytical Chemistry and Residue Data.

PC Code:  124002	DP Barcode:  D364237 

Decision No.:  407555  	Registration No.:  66222-35

Petition No.:  9E7546	Regulatory Action:  Section 3 Registration

Risk Assessment Type:  NA	Case No.:  NA

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

MRID Nos.:  47705801 - 47705808	40 CFR:  §180.598

  SEQ CHAPTER \h \r 1 From:	Julie L. Van Alstine, MPH, Environmental
Health Scientist

		Risk Assessment Branch 1 (RAB1)/Health Effects Division (HED) (7509P)

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

		RAB1/HED (7509P)

TO:		Barbara Madden/Laura Nollen (RM 05)  SEQ CHAPTER \h \r 1   SEQ
CHAPTER \h \r 1 

		Registration Division (RD; 7505P)

Executive Summary

Novaluron, a benzoylphenyl urea compound, is a pesticide chemical
belonging to the class of insecticides called insect-growth regulators
(IGR).  It is currently registered for uses on pome fruits, Brassica
head and stem vegetables, tuberous and corm vegetables, cotton,
tomatoes, and sugarcane.  Registrations on bushberry subgroup 13-07B,
Brassica, leafy greens (subgroup 5B), turnip greens, and stone fruit
(crop group 12) are pending.  The basic producer of novaluron is
Makhteshim-Agan of North America (MANA).  End-use products containing
novaluron as the active ingredient (ai) are formulated as an
emulsifiable concentrate (EC), suspension concentrate (SC), or
water-dispersible granular (WDG).

Under petition 9E7546, the Interregional Research Project Number 4
(IR-4), on behalf of the Agricultural Experiment Stations of AR, CA, FL,
GA, KY, MA, NM, NC, OK, PA, PR, SC, TN, and TX, requests the
establishment of a permanent tolerance for residues of the insecticide
novaluron,
1-[3-chloro-4-(1,1,2-trifluoro-2-trifluoro-methoxyethoxy)phenyl]-3-(2,6-
difluorobenzoyl)urea, in/on:

Vegetable, fruiting, group 8	1.1 ppm

Vegetable, cucurbit, group 9	0.25 ppm

Berry, low growing, subgroup 13-07G	0.50 ppm

Cocona	1.1 ppm

Eggplant, African	1.1 ppm

Eggplant, pea	1.1 ppm

Eggplant, scarlet	1.1 ppm

Goji berry	1.1 ppm

Huckleberry, garden	1.1 ppm

Martynia	1.1 ppm

Naranjilla	1.1 ppm

Okra	1.1 ppm

Roselle	1.1 ppm

Sunberry	1.1 ppm

Tomato, bush	1.1 ppm

Tomato, currant	1.1 ppm

Tomato, tree	1.1 ppm

Bean, snap, succulent	0.60 ppm

Bean, dry	0.20 ppm

Swiss chard	12 ppm

The end-use product associated with these registration requests is
Rimon® 0.83 EC Insecticide (EPA Reg. No. 66222-35), an EC formulation
containing 9.3% ai (equivalent to 0.83 lb ai/gal).  Rimon® is proposed
for application on members of the fruiting vegetable group 8 at a
maximum seasonal rate of 0.23 lb ai/A with 7-day retreatment intervals
(RTIs) and a 1-day preharvest interval (PHI).  For cucurbit vegetable
group 9, applications of Rimon® at a maximum seasonal rate of 0.23 lb
ai/A with 14-day RTIs and a 1-day PHI is proposed.  The label for
cucurbits also proposes the use of a non-ionic surfactant; however the
field trials were conducted without the use of a surfactant.  There are
separate use directions for strawberry and the remaining commodities in
low-growing berry subgroup 13-07G.  For strawberries, applications of
Rimon® at a maximum seasonal rate of 0.23 lb ai/A with 14-day RTIs and
a 1-day PHI is proposed.  For the remaining commodities in the
low-growing berry subgroup 13-07G, applications of Rimon® at a maximum
seasonal rate of 0.23 lb ai/A with a 7-day RTI and 1-day PHI is
proposed.  For snap and dry beans, applications of Rimon® at a maximum
seasonal rate of 0.23 lb ai/A with 7-day RTIs and a 1-day PHI is
proposed.  For Swiss chard, applications of Rimon® at a maximum
seasonal rate of 0.23 lb ai/A with 7-day RTIs and a 1-day PHI is
proposed.  The label states that no surfactants should be used with
Rimon® on snap and dry beans and Swiss chard.  A revised Section B is
requested which specifies that the use of adjuvants/surfactants
(including non-ionic surfactants) on fruiting vegetable group 8,
cucurbit vegetable group 9, low-growing berry subgroup 13-07G, and
strawberry is prohibited and includes a statement which prohibits the
use of novaluron on crops grown for food in greenhouses, except
tomatoes.  The revised Section B should also correct “lowbush berry”
to “lowbush blueberry” in the low-growing berry subgroup 13-07G
section of the label.  

Tolerances have been established for residues of novaluron under 40 CFR
§180.598.  The tolerance expression for both plants and livestock is in
terms of the insecticide novaluron only.  Residue tolerances have been
established for novaluron in/on cotton, Brassica head and stem
vegetables (subgroup 5A), pome fruit (group 11), tuberous and corm
vegetables (subgroup 1C), tomatoes, and sugarcane at levels ranging from
0.05 to 30 ppm.  Tolerances are pending for bushberry subgroup 13-07B
(7.0 ppm), Brassica leafy greens subgroup 5B (25 ppm), turnip greens (25
ppm), and stone fruit crop group 12 except cherries (1.9 ppm), cherries
(8.0 ppm), and dried plum (2.6 ppm).  Residue tolerances for novaluron
in/on livestock have been established at 20 ppm (milk fat), 11 ppm (fat
of cattle, goat, horse, and sheep), 1.0 ppm (milk and kidney and liver
of cattle, goat, horse, and sheep), 0.60 ppm [meat and meat byproducts
(except liver and kidney) of cattle, goat, horse, and sheep], 0.40 ppm
(poultry fat), 0.05 ppm (egg and hog fat), 0.04 ppm (poultry meat
byproducts), 0.03 ppm (poultry meat), and 0.01 ppm (meat and meat
byproducts of hog).  A time-limited tolerance, with an expiration date
of 31-DEC-2011, is established in association with a Section 18
Emergency Exemption for strawberries at 0.50 ppm.  The exemption
tolerance for strawberries will be superseded by the new proposed use on
bushberry crop subgroup 13-07G.  

The nature of the residue in plants is understood based on acceptable
plant metabolism studies reflecting foliar uses on apples, cabbage,
cotton, and potatoes.  HED has previously concluded that the residue of
concern in plants is novaluron only for tolerance enforcement and risk
assessment (Memo, G. Kramer et al., 03-FEB-2004; D297646).

HED also previously concluded that the nature of the residue in
livestock is adequately understood based on the submitted goat and
poultry metabolism studies (Memo, G. Kramer, 22-MAR-2004; D285474).  The
HED MARC determined that the residue of concern in livestock for
purposes of tolerance enforcement and risk assessment is novaluron only
(Memo, G. Kramer et al., 03-FEB-2004; D297646).

The available confined rotational crop study is adequate.  The HED
Metabolism Assessment Review Committee (MARC) has determined that for
tolerance assessment and risk assessment, parent only is the residue of
concern (Memo, G. Kramer et al., 03-FEB-2004; D297646).  Based on the
results of the confined rotational crop study, the appropriate plantback
interval (PBI) for all non-labeled crops is 30 days.  The current and
proposed labels include a restriction that only registered crops may be
rotated to a treated field within 30 days of the final application,
which is appropriate for this petition.  

There are adequate residue analytical methods for the enforcement of
residue tolerances.  For analysis of crop matrices for residues of
novaluron, gas chromatography/electron-capture detection (GC/ECD) and
high-performance liquid chromatography/ultraviolet (HPLC/UV) methods are
available.  These methods have undergone successful validation by the
Analytical Chemistry Branch of the Biological and Economics Analysis
Division (ACB/BEAD) and have been forwarded to Food and Drug
Administration (FDA) for inclusion in the Pesticide Analytical Method
Volume II (PAM II).  

The GC/ECD enforcement method (with minor modifications) was used for
data-collection in the analysis of samples collected from the bell and
non-bell pepper, cantaloupe, summer squash, strawberry, snap bean, dry
bean, and Swiss chard field trials.  The method was adequately validated
in conjunction with the studies.  Cucumber samples were analyzed using a
method based on Pyxant Labs Inc. mass spectrometry (MS) method number
METH1585-00.00, entitled “Determination of Novaluron in Crop Matrices
by LC/MS/MS.”  The method has not been previously reviewed; however,
it is similar to the GC/ECD enforcement method.  The method was
adequately validated in conjunction with the cucumber study.  

The requirements for Multiresidue Methods (MRMs) testing data for
novaluron are fulfilled.  The available data indicate that novaluron
could not be recovered through application of the multiresidue
protocols.  

There are adequate storage stability data to validate the storage
conditions and durations of samples collected from the bell pepper,
cucumber, cantaloupe, summer squash, strawberry, snap bean, dry bean,
and Swiss chard field trials.  Previously submitted storage stability
data indicate that novaluron is reasonably stable for at least 5-12
months under frozen storage in/on apples, broccoli, cabbage, pears,
potatoes, tomatoes, blueberries, turnip greens, and peaches.  In
addition, concurrent storage stability data were submitted confirming
the stability of novaluron residues in/on bell pepper for 6.7 months
(204 days), cantaloupe for 7.0 months (214 days), summer squash for 9.4
months (286 days), strawberry for 11.7 months (355 days), snap bean pods
with seeds for 8.6 months (263 days), snap bean foliage for 8.7 months
(264 days), dry bean seed for 5.0 months (151 days), and Swiss chard for
11.7 months (356 days).

Concurrent storage stability data for cucumbers and non-bell peppers
were not generated.  Current Agency regulatory guidelines require that
stability of residues for the duration of storage be shown either in the
requested crop (or representative crop) or in at least five diverse
crops.  While freezer storage stability data have not been submitted for
the duration of cucumber storage, pome fruits (apple) and fruiting
vegetables (tomato) contain relatively high water content and residues
in/on these commodities are expected to have similar stability when
frozen [Organization for Economic Cooperation and Development (OECD)
Guideline for the Testing of Chemicals – Stability of Pesticide
Residues in Stored Commodities; adopted by OECD 16 October 2007].  As
such, the freezer storage stability data on apple and tomato may be
extended to cucumbers for the purpose of these residue trials.  The
concurrent storage stability study for bell peppers may be translated to
non-bell peppers.  

The submitted field trial residue data for bell and non-bell peppers,
cucumbers, cantaloupe, summer squash, strawberries, snap beans, dry bean
seed, and Swiss chard are adequate to support the establishment of the
requested crop/subgroup tolerances.  

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

The field trial data were entered into the Agency’s maximum residue
limits (MRL) tolerance spreadsheet to determine appropriate tolerances. 
The maximum-likelihood estimation (MLE) spreadsheet was used for bell
peppers, non-bell peppers, cantaloupe, summer squash, and dry bean seed.
 The output from the tolerance spreadsheet supports the IR-4 proposed
tolerance of 0.60 ppm for residues of novaluron in/on snap beans and 12
ppm for residues of novaluron in/on Swiss chard.  The tolerance
spreadsheet output did not support IR-4’s proposal of 1.1 ppm for
residues of novaluron in/on vegetable, fruiting, crop group 8 and
miscellaneous fruiting vegetables; 0.25 ppm for vegetable, cucurbit,
crop group 9; 0.50 ppm for berry, low-growing, crop subgroup 13-07G; and
0.20 ppm for dry bean seed.  The appropriate tolerances are 1.0 ppm for
residues of novaluron in/on vegetable, fruiting, crop group 8 and
miscellaneous fruiting vegetables; 0.15 ppm for vegetable, cucurbit,
crop group 9; 0.45 ppm for berry, low-growing, subgroup 13-07G; and 0.30
ppm for dry bean seed.  

No Codex, Canadian, or Mexican MRLs have been established for novaluron
in/on the proposed commodities.  Canada is currently in the process of
reviewing the use of novaluron on strawberries, snap beans, and bell and
non-bell peppers.  EPA and PMRA tolerance recommendations have been
harmonized at 0.45 ppm for low-growing berry subgroup 13-07G and 0.60
for edible-podded snap beans.  The PMRA has not received petitions for
the use of novaluron on fruiting vegetable group 8 and will be setting
tolerances for bell and non-bell peppers at 0.80 ppm and 0.90 ppm,
respectively (personal communication with Melissa Watchorn of PMRA,
30-NOV-2009).  

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

Pending submission of revised Sections B and F (see requirements under
Directions for Use and Proposed Tolerances), there are no residue
chemistry issues that would preclude granting an unconditional
registration for the use of novaluron on the requested crops.  

The proposed uses and the submitted data support the following permanent
tolerances for residues of the insecticide novaluron, including its
metabolites and degradates, in or on the commodities in the table below.
 Compliance with the tolerance levels specified below is to be
determined by measuring only novaluron
(N-[[[3-chloro-4-[1,1,2-trifluoro-2-(trifluoromethoxy)ethoxy]phenyl]amin
o]carbonyl]-2,6-difluorobenzamide) in or on the following raw
agricultural commodities (RACs):

Vegetable, cucurbit, group 9	0.15 ppm

	Okra	1.0 ppm

Vegetable, fruiting, group 8	1.0 ppm

	Roselle	1.0 ppm

Cocona		1.0 ppm

	Sunberry	1.0 ppm

Eggplant, African	1.0 ppm

	Tomato, bush	1.0 ppm

Eggplant, pea	1.0 ppm

	Tomato, currant	1.0 ppm

Eggplant, scarlet	1.0 ppm

	Tomato, tree	1.0 ppm

Goji berry	1.0 ppm

	Berry, low-growing, subgroup 13-07G	0.45 ppm

Huckleberry, garden	1.0 ppm

	Bean, snap, succulent	0.60 ppm

Martynia	1.0 ppm

	Bean, dry, seed	0.30 ppm

Naranjilla	1.0 ppm

	Swiss chard	12 ppm

A human-health risk assessment is forthcoming in a separate document
(D363988).

860.1200 Directions for Use

A revised Section B for petition number 9E7546 should be submitted
which:

Specifies that the use of adjuvants/surfactants (including non-ionic
surfactants) on fruiting vegetable group 8, cucurbit vegetable group 9,
strawberry, and low-growing berry subgroup 13-07G is prohibited;

Corrects “lowbush berry” to “lowbush blueberry” in the
low-growing berry subgroup 13-07G section of the label; and

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

860.1550 Proposed Tolerances

The proposed tolerance expression for petition number 9E7546 is written
in terms of “tolerances for combined residues of the insecticide
novaluron,
1-[3-chloro-4(1,1,2-trifluoro-2-trifluoro-methoxyethoxy)phenyl]-3-(2,6-d
ifluorobenzoyl)urea.”  A revised Section F for petition number 9E7546
should be submitted to remove the word combined and cite the appropriate
CAS name for novaluron:

“Tolerances are established for residues of the insecticide novaluron,
including its metabolites and degradates, in or on the commodities in
the table below.  Compliance with the tolerance levels specified below
is to be determined by measuring only novaluron
(N-[[[3-chloro-4-[1,1,2-trifluoro-2-(trifluoromethoxy)ethoxy]phenyl]amin
o]carbonyl]-2,6-difluorobenzamide) in or on the following raw
agricultural commodities:”

A revised Section F is requested which reflects the recommended
tolerances and commodity definitions presented in Table 20.  

Notes to RD:  The currently established tomato tolerance and the
time-limited tolerance for strawberry should be removed from 40 CFR
§180.598.  Additionally, the pending tolerance for bushberry subgroup
13-07B (7.0 ppm) should be amended to “bushberry subgroup 13-07B,
except lowbush blueberry.”

Background

  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® 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, 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

	UV/visible absorption spectrum	Molar absorption coefficients of at 3
maximum absorbances:

15,400 L/mol ( cm at 253 nm (neutral)

9,780 L/mol ( cm at 253 nm (acidic)

20,500 L/mol ( cm at 263 nm (basic)

	

860.1200  Directions for Use

IR-4 has submitted a draft label, dated 16-MAR-2009, for Rimon® 0.83 EC
Insecticide (EPA Reg. No. 66222-35) to include the proposed new uses
(see Table 3) on fruiting vegetable group 8, cucurbit vegetable group 9,
low-growing berry subgroup 13-07G, cocona, African eggplant, pea
eggplant, scarlet eggplant, goji berry, garden huckleberry, martynia,
naranjilla, okra, roselle, sunberry, bush tomato, currant tomato, tree
tomato, snap beans, dry bean seed, and Swiss chard.  

Table 3.  Summary of Directions for Use of Novaluron.

Application Equipment	Formulation

[EPA Reg. No.]	Applic. Rate 

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

(lb ai/A)	PHI

(days)	Use Directions and Limitations

Fruiting Vegetables (field) [tomatoes (including bush, currant, and tree
tomatoes), peppers, eggplants (including African, pea, and scarlet
eggplants), tomatillo, groundcherry, pepino, okra, cocona, goji berry,
garden huckleberry, martynia, naranjilla, roselle, and sunberry]

Groundboom/Aerial	0.83 lb/gal EC

[66222-35]	0.058-0.078	3-41,2,3	0.23	1	Repeat applications as needed to
protect new foliage growth, blooms, and fruit, but not less than 7 days
apart.  1-day PHI; 12-hour REI.

Low-Growing Berry Subgroup 13G [cranberry, lingonberry, muntries,
partridgeberry, bearberry, bilberry, lowbush berry, and cloudberry]

Groundboom/Aerial	0.83 lb/gal EC

[66222-35]	0.078	33	0.23	1	Repeat applications as needed to protect new
foliage growth, blooms, and fruit, but not less than 7 days apart. 
1-day PHI; 12-hour REI.

Strawberry

Groundboom/Aerial	0.83 lb/gal EC

[66222-35]	0.058-0.078	3-4	0.23	1	Repeat applications as needed to
protect new foliage growth, blooms, and fruit, but not less than 14 days
apart.  1-day PHI; 12-hour REI.

Swiss Chard

Groundboom/Aerial	0.83 lb/gal EC

[66222-35]	0.058-0.078	3-43	0.23	1	Repeat applications as needed to
protect new foliage growth, blooms, and fruit, but not less than 7 days
apart.  Do not use surfactants of any kind with Rimon® 0.83EC on this
crop.  1-day PHI; 12-hour REI.

Beans (Snap, Dry)

Groundboom/Aerial	0.83 lb/gal EC

[66222-35]	0.039-0.078	3-62,3	0.23	1	Repeat applications as needed to
protect new foliage growth, blooms, and fruit, but not less than 7 days
apart.  Do not use surfactants of any kind with Rimon® 0.83EC on this
crop.  1-day PHI; 12-hour REI.

Cucurbit Vegetables [balsam apple, balsam pear, chayote (fruit),
cantaloupe, cucumber, Chinese cucumber, gherkin (West Indian), edible
gourd, melon, citron melon, muskmelon, bittermelon, pumpkin, squash,
summer squash, winter squash, watermelon, and Chinese waxgourd]

Groundboom/Aerial	0.83 lb/gal EC

[66222-35]	0.058-0.078	3-42,3	0.23	1	Repeat applications as needed to
protect new foliage growth, blooms, and fruit, but not less than 14 days
apart.  Use of a non-ionic surfactant to enhance coverage and
penetration may improve performance.  1-day PHI; 12-hour REI.

1 For the Colorado potato beetle, no more than two applications should
be made to a single generation and it should not be applied to
successive generations.  

2 No more than two applications against whiteflies or thrips per season
should be used.  

3 For most effective control, fields should be scouted.

For ground applications to vegetables, a minimum spray volume of 10
gallons per acre (GPA) should be used.  Aerial applications are to be
made in 2-10 GPA.  For orchard spraying, applications by conventional
ground sprayers should be no less than 75 GPA for trees less than 10
feet tall, and 100 to 400 GPA on trees greater than 10 feet tall. 
Applications of Rimon® 0.83 EC may also be made through sprinkler
irrigation systems; use of other types of irrigation systems are
prohibited.  The accepted (master) label for Rimon® 0.83 EC Insecticide
states that only registered crops may be rotated in a treated field
within 30 days of application.  The current and proposed labels include
a restriction that only registered crops may be rotated to a treated
field within 30 days of the final application.  Rimon® may be applied
alone, as a tankmix, or in rotation with other registered insecticides. 
The label states that no surfactants should be used with Rimon® on snap
and dry beans and Swiss chard.  A revised Section B is requested which
specifies that the use of adjuvants/surfactants (including non-ionic
surfactants) on fruiting vegetable group 8, cucurbit vegetable group 9,
low-growing berry subgroup 13-07G, and strawberry is prohibited and
includes a statement which prohibits the use of novaluron on crops grown
for food in greenhouses, except tomatoes.  The revised section B should
also correct “lowbush berry” to “lowbush blueberry” in the
low-growing berry subgroup 13-07G section of the label.  

 

Conclusions:  The proposed label is adequate to allow evaluation of the
residue data relative to the proposed new uses on fruiting vegetable
group 8, cucurbit vegetable group 9, low-growing berry crop subgroup
13-07G, cocona, African eggplant, pea eggplant, scarlet eggplant, goji
berry, garden huckleberry, martynia, naranjilla, okra, roselle,
sunberry, bush tomato, currant tomato, tree tomato, snap beans, dry
beans, and Swiss chard.  A revised Section B is requested which:  

Specifies that the use of adjuvants/surfactants (including non-ionic
surfactants) on fruiting vegetable group 8, cucurbit vegetable group 9,
strawberry, and low-growing berry subgroup 13-07G is prohibited;

Corrects “lowbush berry” to “lowbush blueberry” in the
low-growing berry subgroup 13-07G section of the label; and

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

860.1300 Nature of the Residue - Plants

  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 (03-FEB-2004) determined that the residue of concern in crops
for purposes of tolerance enforcement and risk assessment is novaluron
only.

860.1300 Nature of the Residue - Livestock

HED also previously concluded that the nature of the residue in
livestock is adequately understood based on the submitted goat and
poultry metabolism studies (Memo, G. Kramer, 22-MAR-2004; D285474).  The
HED MARC determined that the residue of concern in livestock for
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:    SEQ CHAPTER \h \r 1 MANA previously submitted
under PP#2F6430 a GC/ECD residue analytical method for the analysis of
residues of novaluron in/on pome fruit, cabbage, and potato commodities.
 Briefly, residues in/on homogenized crop samples are extracted with
methanol/water.  The filtered extracts are concentrated to aqueous and
repeatedly partitioned with hexane.  The resulting hexane fractions are
cleaned up by chromatography through an amino solid-phase extraction
(NH2-SPE) cartridge, the eluate is evaporated to dryness, and residues
are redissolved in ethyl acetate or hexane for analysis by GC/ECD.  The
validated limits of quantitation (LOQs) are 0.01 ppm for residues in/on
potatoes and 0.05 ppm for residues in/on apples (including juice and wet
pomace) and cabbage.

A second method, HPLC/UV, was submitted for the analysis of novaluron
residues only in/on cotton commodities.  Similarly, samples are
extracted with acetonitrile (ACN) or ACN/water, and repeatedly
partitioned with hexane, or dichloromethane and then hexane.  The
resulting ACN fraction is cleaned up by gel-permeation chromatography
(GPC), silica-gel chromatography, and/or NH2-SPE for HPLC/UV analysis. 
The validated LOQ is 0.05 ppm for undelinted cottonseed, cotton gin
byproducts, and the processed commodities of hulls, meal, and refined
oil.

Successful independent laboratory validations (ILVs) of the GC/ECD and
HPLC/UV methods have been completed with apples and undelinted
cottonseed, respectively.  Acceptable radiovalidation data have been
submitted and reviewed in D325183 for the GC/ECD method.  An
interference study was requested and a specific single-analyte
confirmatory method was submitted, reviewed, and considered acceptable
(Memo, J. Langsdale, 21-OCT-2008; D355574).

The ACB concluded that based upon review of the submitted method
validation data, without laboratory validation, that the GC/ECD and
HPLC/UV methods appear suitable for food tolerance enforcement in plants
(apples, cabbage, potatoes) and cotton.  ACB recommended that the
analytical methods do not need to be laboratory validated by EPA
(DP306998).  Both methods have been forwarded to the FDA for inclusion
in the PAM II as a Letter Method (D307595).

Pepper (Bell and Non-Bell) Data-Collection:  Samples of peppers were
analyzed for residues of novaluron using the GC/ECD enforcement method. 
Briefly, homogenized pepper samples were extracted using methanol:water
(70:30, v:v), filtered, partitioned into hexane, and cleaned up through
a NH2-SPE column.  Residues of novaluron were quantitated by GC/ECD.

The method was adequately validated using samples of untreated bell
pepper fortified with novaluron at 0.05-5 ppm.  In addition, the method
was validated concurrently with the analysis of field samples, using
samples of untreated pepper (bell and non-bell) fortified with novaluron
at 0.05 ppm.  The lowest level of method validation (LLMV) was 0.05 ppm
for novaluron in/on bell and non-bell pepper.  

Cucumber Data-Collection:  Samples of cucumber were analyzed for
residues of novaluron using a high-performance liquid chromatography
method with tandem mass-spectrometry detection (LC/MS/MS; Pyxant Method
METH1585.00-00).  Method METH1585-00.00 has not been previously reviewed
by the EPA; however it is similar to the GC/ECD method previously
proposed for enforcement purposes.  Briefly, samples of cucumber were
extracted twice using methanol:water (70:30, v:v).  The extract was
filtered and diluted with extraction solvent for LC/MS/MS analysis.  

Prior to the analysis of field samples, the method was validated using
samples of untreated cucumber fortified with novaluron at 0.05-25.2 ppm.
 In addition, the method was validated concurrently with the analysis of
field samples, using samples of untreated cucumber fortified with
novaluron at 0.05 and 25 ppm.  The LLMV was 0.05 ppm for novaluron
residues in/on cucumber.

Cantaloupe Data-Collection:  Samples of cantaloupe were analyzed for
residues of novaluron using a method similar to the GC/ECD enforcement
method.  Briefly, homogenized cantaloupe samples were extracted using
methanol:water (70:30, v:v), filtered, partitioned into ethyl acetate,
and cleaned up through an NH2-SPE column.  Residues of novaluron were
quantitated by GC/ECD.

Prior to the analysis of field samples, the method was validated using
samples of untreated cantaloupe fortified at 0.05-5.0 ppm.  In addition,
the method was validated concurrently with the analysis of field
samples, using samples of untreated cantaloupe fortified at 0.05 and 0.5
ppm.  The LLMV was 0.05 ppm for novaluron residues in/on cantaloupe.

Summer Squash Data-Collection:  Samples of summer squash were analyzed
for residues of novaluron using a method similar to the GC/ECD
enforcement method.  Briefly, homogenized summer squash samples were
extracted using methanol:water (70:30, v:v), filtered, partitioned into
ethyl acetate, and cleaned up through an NH2-SPE column.  Residues of
novaluron were quantitated by GC/ECD.

Prior to the analysis of field samples, the method was validated using
samples of untreated summer squash fortified at 0.05-5.0 ppm.  In
addition, the method was validated concurrently with the analysis of
field samples, using samples of untreated summer squash fortified at
0.05 and 0.5 ppm.  The LLMV was 0.05 ppm for novaluron residues in/on
summer squash.

Strawberry Data-Collection:  Samples of strawberry were analyzed for
residues of novaluron using a method similar to the GC/ECD enforcement
method.  Briefly, homogenized strawberry samples were extracted using
methanol:water (70:30, v:v), filtered, partitioned into ethyl acetate,
and cleaned up through an NH2-SPE column.  Residues of novaluron were
quantitated by GC/ECD.

Prior to the analysis of field samples, the method was adequately
validated using samples of untreated strawberry fortified with novaluron
at 0.05-5.0 ppm.  In addition, the method was validated concurrently
with the analysis of field samples, using samples of untreated
strawberry fortified with novaluron at 0.05-5.0 ppm.  The LLMV was 0.05
ppm for novaluron in/on strawberry.  

Snap Bean Data-Collection:  Samples of snap bean were analyzed for
residues of novaluron using a method similar to the GC/ECD enforcement
method.  Briefly, homogenized snap bean samples were extracted using
methanol:water (70:30, v:v), filtered, homogenized again using only
methanol, partitioned into hexane, and the hexane extracts were
evaporated using a Turbo Vap.  The sample was then brought to a final
volume with hexane and analyzed for residues of novaluron using GC/EC
without a SPE cleanup step.  

Prior to the analysis of field samples, the method was validated using
samples of untreated snap bean pods with seeds and snap bean foliage
fortified with novaluron at 0.050-5.0 ppm.  In addition, the method was
validated concurrently with the analysis of field samples, using samples
of untreated snap bean pods with seeds fortified with novaluron at 0.05
and 0.50 ppm and untreated snap bean foliage fortified with novaluron at
0.05-30.0 ppm.  The LLMV was 0.05 ppm for novaluron in/on both snap bean
pods with seeds and snap bean foliage.

Dry Bean Seed Data-Collection:  Samples of dry bean seed were analyzed
for residues of novaluron using the GC/ECD enforcement method.  Briefly,
homogenized dry bean seed samples were extracted using methanol:water
(70:30, v:v), filtered, partitioned into hexane, and cleaned up through
a NH2-SPE column.  Residues of novaluron were quantitated by GC/ECD.  

Prior to the analysis of field samples, the method was validated using
samples of untreated bean seed fortified with novaluron at 0.05-5 ppm. 
In addition, the method was validated concurrently with the analysis of
field samples, using samples of untreated bean seed fortified with
novaluron at 0.05 and 0.5 ppm.  The LLMV was 0.05 ppm for novaluron
in/on dry bean.

Swiss Chard Data-Collection:  Samples of Swiss chard were analyzed for
residues of novaluron using a method similar to the GC/ECD enforcement
method.  Briefly, homogenized Swiss chard samples were extracted using
methanol:water (70:30, v:v), filtered, partitioned into hexane, and
concentrated.  Residues of novaluron were quantitated by GC/ECD.  

Prior to the analysis of field samples, the method was validated using
samples of untreated Swiss chard fortified with novaluron at 0.05-10
ppm.  In addition, the method was validated concurrently with the
analysis of field samples, using samples of untreated Swiss chard
fortified with novaluron at 0.05-5.0 ppm.  The LLMV was 0.05 ppm for
novaluron in/on Swiss chard.  

Conclusions:  HED previously concluded that the submitted GC/ECD method
is adequate as an enforcement method for novaluron, the terminal residue
of concern in plants (apple, cabbage, cotton, and potato).  The
enforcement method, with minor modifications, was used for data
collection and the methods were adequately validated in conjunction with
the bell and non-bell pepper, cucumber, cantaloupe, summer squash,
strawberry, snap bean, dry bean seed, and Swiss chard field trials
associated with the new uses discussed herein.  

 

860.1360 Multiresidue Methods

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

  SEQ CHAPTER \h \r 1 Novaluron was tested through the FDA MRM Test
guidelines in PAM I, Appendix II (JAN-1994).  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)

Storage stability data for novaluron were presented in PP#2F6430.  These
data show that fortified residues of novaluron are reasonably stable
under frozen conditions in/on pears for up to 5.2 months; broccoli,
cabbage, and tomato for up to 6 months; apple and potato for up to 12
months; and apple juice for up to 3.3 months.  Additional concurrent
storage stability data was submitted for blueberries, mustard greens,
and peaches in PP#8E7425, which demonstrated that fortified residues of
novaluron are relatively stable under frozen conditions in/on blueberry,
mustard greens, and peaches for up to 150 days, 464 days, and 116 days,
respectively.  

In conjunction with the subject bell pepper, cantaloupe, summer squash,
strawberry, snap bean, dry bean seed, and Swiss chard field trial
studies, concurrent storage stability data were generated which
demonstrate that fortified residues of novaluron are relatively stable
under frozen conditions in/on bell pepper for 6.7 months (204 days),
cantaloupe for 7.0 months (214 days), summer squash for 9.4 months (286
days), strawberry for 11.7 months (355 days), snap bean pods with seeds
for 8.6 months (263 days), snap bean foliage for 8.7 months (264 days),
dry bean seed for 5.0 months (151 days), and Swiss chard for 11.7 months
(356 days).  Although no 0-day data were provided with the concurrent
storage stability data for these commodities, no additional data will be
required in consideration of the stability of novaluron in/on other crop
matrices.

Concurrent storage stability data for cucumbers and non-bell peppers
were not generated.  Current Agency regulatory guidelines require that
stability of residues for the duration of storage be shown either in the
requested crop (or representative crop) or in at least five diverse
crops.  While freezer storage stability data have not been submitted for
the duration of cucumber storage, pome fruits (apple) and fruiting
vegetables (tomato) contain relatively high water content and residues
in/on these commodities are expected to have similar stability when
frozen [OECD Guideline for the Testing of Chemicals – Stability of
Pesticide Residues in Stored Commodities; adopted by OECD 16 October
2007].  As such, the freezer storage stability data on tomato and apple
may be extended to cucumbers for the purpose of these residue trials. 
The freezer storage stability study for bell peppers may be translated
to non-bell peppers.  

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

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

Matrix 	Storage Temperature (°C)	Actual Storage Duration	Interval of
Demonstrated Storage Stability

Bell pepper	-29 to -15	85-164 days

(2.8-5.4 months)	Up to 204 days for residues of novaluron in/on frozen
bell pepper (concurrent storage stability data).

Non-bell pepper	-29 to -15	78-153 days

≤-20	61-142 days

(2.0-4.7 months)	Translated from tomato (residues of novaluron are
stable in/on tomato stored frozen for up to 6 months1).

Cantaloupe	-40 to -6	86-164 days2

(2.8-5.4 months)	Up to 214 days for residues of novaluron in/on frozen
cantaloupe (concurrent storage stability data).

Summer squash	-40 to -6	192-283 days2

(6.3-9.3 months)	Up to 286 days for residues of novaluron in/on frozen
(concurrent storage stability data).

Strawberry	-40 to -2	49-235 days3

(1.6-7.7 months)	Up to 355 days for residues of novaluron in/on frozen
strawberry (concurrent storage stability data).

Snap bean pods with seeds	-21 ± 7	175-228 days4

(5.7-7.5 months)	Up to 263 days for residues of novaluron in/on frozen
snap bean (concurrent storage stability data).

Snap bean foliage	-21 ± 7	175-228 days4

(5.7-7.5 months)	Up to 264 days for residues of novaluron in/on frozen
snap bean foliage (concurrent storage stability data).

Dry bean seed	-21 ± 7	98-147 days4

(3.2-4.8 months)	Up to 151 days for residues of novaluron in/on frozen
dry bean (concurrent storage stability data).

Swiss chard	-21 ± 7	54-242 days5

(1.8-8.0 months)	Up to 356 days for residues of novaluron in/on frozen
Swiss chard (concurrent storage stability data).

1 Refer to D285474, G. Kramer, 22-MAR-2004.

  SEQ CHAPTER \h \r 1 2 Actual storage duration from harvest to
analysis.  Samples were analyzed within 0-10 days of extraction.

3 Actual storage duration from harvest to analysis.  Samples were
analyzed within 1-16 days of extraction. 

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

5 Actual storage duration from harvest to analysis.  Samples were
extracted and analyzed on the same day. 

Conclusions:  In conjunction with previously submitted storage stability
data for novaluron on a variety of crops, the concurrent storage
stability conducted with the bell pepper, cantaloupe, summer squash,
strawberry, snap bean, dry bean seed, and Swiss chard field trials will
support the sample conditions and durations of storage for these
studies.  The freezer storage stability data on tomato and apple may be
extended to cucumbers and the bell pepper freezer storage stability data
may be translated to non-bell peppers for the purpose of these residue
trials.  

860.1480 Meat, Milk, Poultry, and Eggs

There are no livestock feed items associated with the proposed uses.

860.1500 Crop Field Trials

Pepper (Bell and Non-Bell)

DER Reference:  47705801.der.doc

Six bell pepper field trials were conducted in the U.S. in North
American Free Trade Agreement (NAFTA) Growing Zones 2 (GA; 1 trial), 3
(FL; 1 trial), 5 (OH; 1 trial), 6 (TX; 1 trial), and 10 (CA; 2 trials)
and three bell pepper trials were conducted in Canada in NAFTA Growing
Zones 5 (ON; 2 trials) and 5B (QC; 1 trial).  Four non-bell pepper field
trials were conducted in the U.S. in NAFTA Growing Zones 3 (FL; 1
trial), 5 (OH; 1 trial), 6 (TX; 1 trial), and 10 (NM; 1 trial).

Each trial site consisted of one untreated plot and one or two treated
plots.  At each trial site, three broadcast or directed spray
applications of a 0.83 lb/gal EC formulation of novaluron (Rimon®
0.83EC; EPA Reg. No. 66222-35) were made to pepper plants at 0.077-0.084
lb ai/A per application, with 6- to 8-day RTIs, for a total rate of
0.234-0.245 lb ai/A.  At four bell pepper sites, a second plot was
treated with a 0.83 lb/gal SC formulation of novaluron (Pedestal®
Novaluron Insecticide; EPA Reg. No. 66222-40) in the same manner. 
Applications were made using ground equipment in 31-51 GPA spray
volumes, without an adjuvant.

Samples were harvested at commercial maturity, 1 day after the last
application of novaluron, except for one ON trial where samples were
collected 2 days after the last application.  At the GA trial,
additional samples were collected 4, 8, and 11 days after the last
application to evaluate residue decline.

The results (see Table 11) indicate that residues of novaluron ranged
from <0.05 to 0.37 ppm in/on 18 samples of treated bell pepper and from
<0.05 to 0.36 ppm in/on 8 samples of treated non-bell pepper when
treated with an EC formulation at a total seasonal rate of 0.234-0.245
lb ai/A and harvested at a 1-day PHI (2-day PHI for 1 bell pepper
sample).  Following foliar treatments with the SC formulation at a total
seasonal rate of 0.238-0.244 lb ai/A, residues of novaluron ranged from
<0.05 to 0.28 ppm in/on 8 samples of treated bell pepper when harvested
at a 1-day PHI.  

In the residue decline trial, average residues of novaluron decreased
from 0.29 ppm at the 0-day PHI to 0.22 ppm at the 4-day PHI, and then
increased to 0.28 and 0.37 ppm at the 8- and 11-day PHIs, respectively. 
Overall, the residue decline trial indicated that residues generally
stayed the same with increasing PHIs for bell peppers.  The side-by-side
field trial data indicate the use of the SC formulation will yield
similar residues in/on bell and non-bell pepper commodities as the use
of the EC formulation.

TABLE 11.  Summary of Residue Data from Crop Field Trials with Novaluron
(Bell and Non-Bell Peppers).

Commodity	Total Applic. Rate

 (lb ai/A)

 [g ai/ha]	PHI (days)	Residue Levels1 (ppm)

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

Treated with EC formulation

Pepper, bell	0.234-0.244

[262.2-273.5]	1; 23	18	<0.05	0.37	0.37	0.07	0.14	0.11

Pepper, non-bell	0.240-0.245

[269.0-274.6]	1	8	<0.05	0.36	0.35	0.13	0.16	0.13

Treated with SC formulation

Pepper, bell	0.238-0.244

[266.8-273.5]	1	8	<0.05	0.28	0.28	0.05	0.11	0.10

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

2 HAFT = highest-average field trial.

3 At one trial site, samples were harvested 2 days after last
application.

Conclusions:  The number and locations of field trials are in accordance
with OPPTS Guideline 860.1500 for bell pepper, as a representative
commodity for fruiting vegetable crop group 8 (excluding cucurbits). 
Field trial data for tomato (the other representative crop of the
fruiting vegetable crop group) have been submitted previously (Memo, G.
Kramer, 7-FEB-2008; D379033).  For non-bell peppers, the correct number
of field trials was conducted, but no trials were conducted in the
region which accounts for 50% of non-bell pepper production (Zone 8). 
HED notes that although no non-bell pepper field trials were conducted
in Zone 8, IR-4 did conduct one more field trial than was requested.  In
addition, since the maximum non-bell pepper residues are less than the
maximum bell pepper residues and tomatoes drive the tolerance for
fruiting vegetable crop group 8, HED will not request field trial data
for non-bell peppers in Zone 8.  The field trial data reflect the
proposed use rate and PHI for fruiting vegetable group 8.

The field trial data for bell and non-bell pepper were entered into the
Agency’s MLE spreadsheet and then the Agency’s MRL tolerance
spreadsheet as specified by the Guidance for Setting Pesticide
Tolerances Based on Field Trial Data SOP to determine appropriate
tolerance levels; see Appendix I.  Tolerance values of 0.80 ppm for bell
pepper and 0.90 ppm for non-bell pepper were calculated.  However, as
these values are the less than as the previously set tolerance for
tomato (1.0 ppm), separate tolerances for bell and non-bell pepper will
not be required and the recommended tolerance for residues of novaluron
in/on fruiting vegetable group 8 is 1.0 ppm.

Cucumber

DER Reference:  47705802.der.doc

Six cucumber field trials were conducted in NAFTA Growing Zones 2 (GA,
NC; 1 trial each), 3 (FL; 1 trial), 5 (MI, OH; 1 trial each), and 6 (TX;
1 trial).  Each trial site consisted of one untreated plot and one
treated plot.  At each trial site, three foliar applications of a 0.83
lb/gal EC formulation of novaluron (EPA Reg. No. 66222-35) were made at
0.075-0.085 lb ai/A per application, with 7- to 10-day RTIs, for a total
rate of 0.230-0.249 lb ai/A.  All applications were made as broadcast
applications.  Applications were made using ground equipment in 20-28
GPA spray volumes, without an adjuvant.  Samples were harvested at
commercial maturity, one day after the last application of novaluron. 
Additional treated samples were also collected at one cucumber trial 0,
3, 5, and 7 days after the last application to evaluate residue decline.
 

The results (see Table 12) indicate that following foliar treatments
with the 0.83 lb/gal EC formulation at a total seasonal rate of
0.230-0.249 lb ai/A with a 1-day PHI, residues of novaluron were below
the LOQ (<0.05 ppm) in/on 12 samples of treated cucumber.  Residues of
novaluron were below the LOQ (<0.05 ppm) in/on all cucumber samples from
the decline trial.  

TABLE 12.  Summary of Residue Data from Crop Field Trials with Novaluron
(Cucumber).

Commodity	Total Applic. Rate

(lb ai/A)

[g ai/ha]	PHI (days)	Residue Levels (ppm)1

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

Cucumber	0.230-0.237

[258-266]	1	12	<0.05	<0.05	<0.05	0.05	0.05	--

1 For calculation of the HAFT, median, mean, and standard deviation, the
LOQ (0.05 ppm) was used for residues reported <LOQ.  Standard deviation
was not calculated for data sets where all reported values were <LOQ.

2 HAFT = highest-average field trial.

Cantaloupe

DER Reference:  47705802.der.doc

Eight cantaloupe trials were conducted in NAFTA Growing Zones 2 (NC; 1
trial), 5 (WI; 1 trial), 6 (TX; 2 trials), and 10 (CA; 4 trials).  Each
trial site consisted of one untreated plot and one treated plot.  At
each trial site, three foliar applications of a 0.83 lb/gal EC
formulation of novaluron (EPA Reg. No. 66222-35) were made at
0.075-0.085 lb ai/A per application, with 13- to 16-day RTIs, for a
total rate of 0.230-0.249 lb ai/A.  All applications were made as
broadcast applications with the following exceptions:  at the CA23
trial, all three applications were made as foliar-directed applications;
and at the CA24 trial, the first application was made as a
foliar-direction application.  Applications were made using ground
equipment in 33-42 GPA spray volumes, without an adjuvant.  Samples were
harvested at commercial maturity, one day after the last application of
novaluron.  Additional treated samples were also collected at one
cantaloupe trial 4, 8, and 9 days after the last application to evaluate
residue decline.  

The results (see Table 13) indicate that following foliar treatments
with the 0.83 lb/gal EC formulation at a total seasonal rate of
0.230-0.249 lb ai/A with a 1-day PHI, residues of novaluron ranged from
<0.045 to 0.093 ppm in/on 16 samples of treated cantaloupe.  It is noted
that the cantaloupe trial in which all applications were made as
foliar-directed applications yielded the samples with the maximum
residues.  In the residue decline trials, average residues appeared to
decrease slightly in/on cantaloupe with increasing sampling intervals;
however, residues in/on all samples were near the LOQ.  

TABLE 13.	Summary of Residue Data from Crop Field Trials with Novaluron
(Cantaloupe).

Commodity	Total Applic. Rate

(lb ai/A)

[g ai/ha]	PHI (days)	Residue Levels (ppm)1

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

Cantaloupe	0.239-0.245

[268-275]	1	16	<0.045	0.093	0.091	0.045	0.055	0.018

1 For calculation of the HAFT, median, mean, and standard deviation, the
LOQ (0.045 ppm for cantaloupe) was used for residues reported <LOQ.  

2 HAFT = highest-average field trial.

Summer Squash

DER Reference:  47705802.der.doc

Seven summer squash trials were conducted in NAFTA Growing Zones 2 (NJ,
NC; 1 trial each), 3 (FL; 1 trial), 5 (WI; 1 trial), 6 (TX; 1 trial), 10
(CA; 1 trial), and 11 (WA; 1 trial).  The NJ summer squash trial was
conducted near the border to Zone 1.  Each trial site consisted of one
untreated plot and one treated plot.  At each trial site, three foliar
applications of a 0.83 lb/gal EC formulation of novaluron (EPA Reg. No.
66222-35) were made at 0.075-0.085 lb ai/A per application, with 12- to
15-day RTIs, for a total rate of 0.230-0.249 lb ai/A.  All applications
were made as broadcast applications with the following exceptions:  at
the CA145 trial, the first application was made as a foliar-direction
application; and at the FL13 trial, the first two applications were made
as foliar-directed applications.  Applications were made using ground
equipment in 32-45 GPA spray volumes, without an adjuvant.  Samples were
harvested at commercial maturity, one day after the last application of
novaluron.  No residue decline study was completed for summer squash.  

The results (see Table 14) indicate that following foliar treatments
with the 0.83 lb/gal EC formulation at a total seasonal rate of
0.230-0.249 lb ai/A with a 1-day PHI, residues of novaluron ranged from
<0.039 to 0.074 ppm in/on 14 samples of treated summer squash.  

TABLE 14.  Summary of Residue Data from Crop Field Trials with Novaluron
(Summer Squash).

Commodity	Total Applic. Rate

(lb ai/A)

[g ai/ha]	PHI (days)	Residue Levels (ppm)1

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

Summer squash	0.240-0.249

[269-279]	1	14	<0.039	0.074	0.071	0.039	0.044	0.012

1 For calculation of the HAFT, median, mean, and standard deviation, the
LOQ (0.039 ppm) was used for residues reported <LOQ.

2 HAFT = highest-average field trial.

Conclusions:  The number and locations of field trials are in accordance
with OPPTS Guideline 860.1500 for cucumber, cantaloupe, and summer
squash as representative crops of cucurbit vegetable group 9.  The field
trial data reflect the proposed use rate and PHI for cucurbit vegetable
group 9.

The field trial data for cantaloupe and summer squash were entered into
the Agency’s MLE spreadsheet and then the Agency’s MRL tolerance
spreadsheet as specified by the Guidance for Setting Pesticide
Tolerances Based on Field Trial Data SOP to determine appropriate
tolerance levels; see Appendix I.  Because the cucumber residues were
all below the LOQ (0.05 ppm), the MLE and MRL spreadsheets were not used
for cucumber.  The tolerance spreadsheet recommended a tolerance of 0.15
ppm for cantaloupe and 0.09 ppm for summer squash.  The available data
support a tolerance of 0.15 ppm for residues of novaluron in/on cucurbit
vegetable group 9.

Strawberry

DER Reference:  47705805.der.doc

Ten strawberry trials were conducted in the U.S. and Canada in NAFTA
Growing Zones 1 (NY; 1 trial), 2 (NJ; 1 trial), 3 (FL; 1 trial), 5 (ON;
1 trial), 5A (WI; 1 trial), 5B (QC; 1 trial), 10 (CA; 3 trials), and 12
(OR; 1 trial) during the 2007 growing season.  Each trial site consisted
of one untreated plot and one treated plot.  At each trial site, three
broadcast or directed spray applications of a 0.83 lb/gal EC formulation
of novaluron (Rimon® 0.83EC; EPA Reg. No. 66222-35) were made to
strawberry plants at 0.077-0.084 lb ai/A per application, with 7- to
10-day RTIs, for a total application rate of 0.238-0.251 lb ai/A. 
Applications were made using ground equipment in 50-125 GPA spray
volumes, without an adjuvant.

Samples were harvested at commercial maturity, one day after the last
application of novaluron.  At the ON trial, additional samples were
collected 0, 3, 5, and 8 days after the last application to evaluate
residue decline.

The results (see Table 15) indicate that following foliar treatments
with the 0.83 lb/gal EC formulation at a total seasonal rate of
0.238-0.251 ai/A, residues of novaluron ranged from <0.05 to 0.287 ppm
in/on 20 samples of treated strawberry when harvested at a 1-day PHI. 
In the residue decline trial, average residues of novaluron increased
from 0.153 ppm at the 0-day PHI to 0.174 ppm at the 1-day PHI and then
decreased at later sampling intervals, to 0.110 ppm at the 8-day PHI. 
Overall, the residue decline trial indicated that residues generally
stayed the same with increasing PHIs for strawberries.  

TABLE 15.  Summary of Residue Data from Crop Field Trials with Novaluron
(Strawberry).

Commodity	Total Applic. Rate

 (lb ai/A)

 [g ai/ha]	PHI (days)	Residue Levels1 (ppm)

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

Strawberry	0.238-0.251

[267-281]	1	20	<0.05	0.287	0.250	0.116	0.140	0.071

1 For calculation of the median, mean, and standard deviation, the LLMV
(0.05 ppm) was used for residues reported as below the LLMV.

2 HAFT = highest-average field trial.

Conclusions:  The number and locations of field trials are in accordance
with OPPTS Guideline 860.1500 for strawberry as the representative crop
of the low-growing berry subgroup 13-07G.  The field trial data reflect
the proposed use rate and PHI for strawberry.  The label contains
separate use directions for the remaining commodities in the low-growing
berry subgroup 13-07G.  The total use rates and PHI for these remaining
commodities are equal to the use rates and PHI for the strawberry field
trials; however, the RTI is 7 days as opposed to 14 days for
strawberries.  Although the RTI for the remaining low-growing berry
subgroup 13-07G commodities is less than the strawberry RTI, these
commodities are covered by the strawberry field trials because the
strawberry field trials were conducted using 7- to 8-day RTIs.  

The field trial data for strawberry were entered into the Agency’s
tolerance spreadsheet as specified by the Guidance for Setting Pesticide
Tolerances Based on Field Trial Data SOP to determine appropriate
tolerance levels; see Appendix I.  The available data support a
tolerance of 0.45 ppm for residues of novaluron in/on low-growing berry
subgroup 13-07G.

Snap Bean

DER Reference:  47705806.der.doc

Fourteen snap bean trials were conducted in the U.S. and Canada in NAFTA
Growing Zones 1A (NS; 1 trial), 2 (MD, NC, NJ, and TN; 4 trials), 3 (FL;
2 trials), 5 (ON; 2 trials), 5A (WI; 1 trial), 5B (QC; 2 trials), 10
(CA; 1 trial), and 11 (ID; 1 trial) during the 2006 growing season. 
Each trial site consisted of one untreated plot and one treated plot. 
At each trial site, three foliar applications of a 0.83 lb/gal EC
formulation of novaluron (Rimon® 0.83EC; EPA Reg. No. 66222-35) were
made to bean plants at 0.076-0.088 lb ai/A per application, with 6- to
8-day RTIs, for a total rate of 0.236-0.263 lb ai/A.  All applications
were made as broadcast applications with the following exceptions:  at
the CA19 trial, all three applications were made as foliar-directed
applications; and at both FL trials, the first application was made as a
foliar-directed application.  Applications were made using ground
equipment in 31-47 GPA spray volumes, without an adjuvant.

Samples of snap bean commodities were harvested at commercial maturity,
2-3 days after the last application of novaluron.  At the NC04 trial,
additional samples were collected 1, 8, and 9 days after the last
application to evaluate residue decline.  Samples of snap bean,
consisting of pods with seed, were collected at all of the trials.  In
addition, the protocol required the collection of “foliage” samples,
consisting of the entire, above-ground portion of the bean plant.  This
requirement was misunderstood at numerous trial locations.  In seven of
the trials (MD04, NC04, NS04, ON06, ON07, QC03, and QC04), foliage
samples consisted of the entire above-ground portion of the plant,
exclusive of the pods.  In 6 of the trials, (CA19, FL11, FL12, ID04,
NJ04, and WI04), foliage samples consisted of the entire above-ground
portion of the plant, but there is no indication as to whether or not
the pods were removed.  In the remaining trial (TN04), the foliage
sample consisted of leaves only.

The results (see Table 16) indicate that following foliar treatments
with the 0.83 lb/gal EC formulation at a total seasonal rate of
0.236-0.263 lb ai/A with a 2- to 3-day PHI, residues of novaluron ranged
from <0.05 to 0.46 ppm in/on 28 samples of treated snap bean pods with
seeds, and from 3.0 to 18 ppm in/on 28 samples of treated snap bean
foliage.  Residues of novaluron in/on snap bean foliage from those
trials in which the pods were removed were 5.3-18 ppm.  In the residue
decline trial, residues of novaluron in/on samples of snap bean pods
with seeds remained approximately the same and residues in/on snap bean
foliage decreased slightly from the 1-day to the 9-day PHI.  Overall,
the residue decline trial indicated that residues generally stayed the
same with increasing PHIs for snap bean pods with seeds and snap bean
foliage without pods.   

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

Commodity	Total Applic. Rate

 (lb ai/A)

 [g ai/ha]	PHI (days)	Residue Levels1 (ppm)

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

Snap bean pods with seeds	0.236-0.263

[264.4-295.2]	2-3	28	<0.05	0.46	0.43	0.16	0.18	0.11

Snap bean foliage3	0.238-0.245

[266.8-274.6]	2-3	12	3.0	10	9.7	5.9	6.3	2.3

Snap bean foliage (entire above-ground portion of plants without pods)4
0.236-0.263

[264.4-295.2]	2-3	14	5.3	18	17	7.8	9.1	3.8

Foliage, only leaves5	0.240

[269.0]	3	2	8.1	10	9.1	9.1	9.1	1.3

All Snap bean foliage6	0.236-0.263

[264.4-295.2]	2-3	28	3.0	18	17	7.6	7.9	3.4

1 For calculation of the median, mean, and standard deviation, the LLMV
(0.05 ppm) was used for residues reported as below the calculated LLMV.

2 HAFT = highest-average field trial.

3 The study does not indicate whether or not the pods with seeds were
removed from these samples (CA19; FL11; Fl12; ID04; NJ04; and WI04).

4 Snap bean foliage residue data from trials MD04, NC04, NS04, ON06,
ON07, QC03, and QC04 where the above-ground portion of the plant
excluding the pods was analyzed.

5 The TN04 trial analyzed the leaves only.  

6 All snap bean foliage data, including data from trials where the study
did not indicate whether or not the pods with seeds were removed, data
from trials that analyzed the above-ground portion of the plant
excluding the pods, and data from trial that only analyzed the leaves
collected off the bean plants.  

Conclusions:  The number and locations of field trials are in accordance
with OPPTS Guideline 860.1500 for snap bean.  The field trial data
reflect the proposed use rate but does not reflect the proposed 1-day
PHI.  The field trial PHIs for snap beans was 2-3 days; however given
that the residue decline trial indicated that residues generally stayed
the same with increasing PHIs for snap bean pods with seeds and snap
bean foliage without pods, the 2-3 day PHI data is acceptable for this
petition.   

The field trial data for snap beans were entered into the Agency’s
tolerance spreadsheet as specified by the Guidance for Setting Pesticide
Tolerances Based on Field Trial Data SOP to determine appropriate
tolerance levels; see Appendix I.  The available data support the
proposed tolerance (0.60 ppm) for residues of novaluron in/on snap
beans.

Dry Bean

DER Reference:  47705807.der.doc

Thirteen dry bean trials were conducted in the U.S. in NAFTA Growing
Zones 1 (NY; 1 trial), 5 (MI, OH, SD, and WI; 5 trials), 7 (ND; 2
trials), 8 (CO; 1 trial), 9 (CO; 1 trial) 10 (CA; 1 trial), and 11 (ID
and WA; 1 trial each) during the 2007 growing season.  Each trial site
consisted of one untreated plot and one treated plot.  At each trial
site, three broadcast spray applications of a 0.83 lb/gal EC formulation
(Rimon® 0.83EC; EPA Reg. No. 66222-35) of novaluron were made to bean
plants at 0.078-0.090 lb ai/A per application, with 6- to 11-day RTIs,
for a total rate of 0.237-0.249 lb ai/A.  At the NY08 trial,
foliar-directed applications were made instead of broadcast
applications.  In addition, at the OH13 trial, five broadcast
applications were made, at 0.080-0.081 lb ai/A per application, for a
total rate of 0.402 lb ai/A, because the beans had not matured
sufficiently after three applications.  Applications were made using
ground equipment in 10-45 GPA spray volumes, without an adjuvant.

Samples were harvested one day after the last application of novaluron
except for the ND09 trial where samples were collected two days after
the last application.  At 11 of the field sites, whole bean plants or
bean pods were allowed to dry in the field and/or a greenhouse for up to
22 days before collection of dry bean seed.  No drying was needed at two
of the field sites (ND08 and WI22) and samples of dry bean seed were
collected directly from the plants.  

The results (see Table 17) indicate that following foliar treatments
with the 0.83 lb/gal EC formulation at a total seasonal rate of
0.237-0.402 lb ai/A (266-451 g ai/ha) with a 1-day PHI (2-day PHI for 2
bean samples), residues of novaluron ranged from <0.05 to 0.36 ppm in/on
26 samples of treated dry bean seed.  Residues were below the LLMV in/on
21 of the 26 samples.  The maximum residue (0.36 ppm) occurred at the
ND09 trial where samples were collected at a 2-day PHI.  Residues in/on
samples from the one trial where directed applications were made were
comparable to those in/on samples treated with broadcast applications. 
Residues in/on samples from the OH13 trial where five broadcast
applications were made were <0.05 and were comparable to other residues.
 

No residue decline data were generated for dry bean seed.  A residue
decline study with snap beans was submitted separately (MRID 47705806). 
In that study, residues of novaluron in/on samples of snap bean remained
approximately the same from a 1-day to a 9-day PHI.   

TABLE 17.  Summary of Residue Data from Crop Field Trials with Novaluron
(Dry Bean).

Commodity	Total Applic. Rate

 (lb ai/A)

 [g ai/ha]	PHI (days)	Residue Levels (ppm)1

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

Dry bean	0.237-0.249; 0.402

[266-279; 451]	1; 23	26	<0.05	0.36	0.22	0.05	0.065	0.061

1 For calculation of the HAFT, median, mean, and standard deviation, the
LLMV (0.05 ppm) was used for residues reported below the LLMV.

2 HAFT = highest-average field trial.

3 At one site (Minot, ND trial), samples were harvested 2 days after
last application.  The maximum residue (0.36 ppm) was obtained from this
trial.

Conclusions:  The number and locations of the field trials are in
accordance with OPPTS Guideline 860.1500 for dry beans.  The field trial
data reflect the proposed use rate and PHI for dry beans.

The field trial data for dry beans were entered into the Agency’s MLE
spreadsheet and then the Agency’s MRL tolerance spreadsheet as
specified by the Guidance for Setting Pesticide Tolerances Based on
Field Trial Data SOP to determine appropriate tolerance levels; see
Appendix I.  The available data support a tolerance of 0.30 ppm for
residues of novaluron in/on dry bean seed.

Swiss Chard

DER Reference:  47705808.der.doc

Three Swiss chard trials were conducted in the U.S. in NAFTA Growing
Zones 6 (TX; 1 trial) and 10 (CA; 2 trials) during the 2007 growing
season.  Each trial site consisted of one untreated plot and one treated
plot.  At each trial site, three foliar broadcast or foliar-directed
spray applications of a 0.83 lb/gal EC formulation of novaluron (Rimon®
0.83EC; EPA Reg. No. 66222-35) were made to Swiss chard plants at
0.079-0.082 lb ai/A per application, with 6- to 8-day RTIs, for a total
rate of 0.237-0.243 lb ai/A.  Applications were made using ground
equipment in 22-58 GPA spray volumes, without an adjuvant.  Samples were
harvested at commercial maturity, one day after the last application of
novaluron.  

The results (see Table 18) indicate that following foliar treatments
with the 0.83 lb/gal EC formulation at a total seasonal rate of
0.237-0.243 lb ai/A (266-272 g ai/ha) with a 1-day PHI, residues of
novaluron ranged 2.2-6.6 ppm in/on 6 samples of treated Swiss chard. 
Residues in/on samples treated with foliar-directed applications were
higher (6.4 and 6.6 ppm) than residues in/on samples treated with
broadcast applications (2.2-4.0 ppm).  No residue decline data were
generated for Swiss chard.    

TABLE 18.  Summary of Residue Data from Crop Field Trials with Novaluron
(Swiss Chard).

Commodity	Total Applic. Rate (lb ai/A) [g ai/ha]	PHI (days)	Residue
Levels (ppm)

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

Swiss chard plant	0.237-0.243

[266-272]	1	6	2.2	6.6	6.5	3.8	4.2	1.9

1 HAFT = highest-average field trial.

Conclusions:  The number and locations of field trials are in accordance
with OPPTS Guideline 860.1500 for Swiss chard.  The field trial data
reflect the proposed use rate and PHI for Swiss chard.  

The field trial data for Swiss chard were entered into the Agency’s
tolerance spreadsheet as specified by the Guidance for Setting Pesticide
Tolerances Based on Field Trial Data SOP to determine appropriate
tolerance levels; see Appendix I.  The available data support the
proposed tolerance (12 ppm) for residues of novaluron in/on Swiss chard.

860.1520 Processed Food and Feed

HED does not require residue data for any processed commodities
associated with the proposed crops.  Therefore, data requirements for
processed food and feed are not relevant to these commodities

  SEQ CHAPTER \h \r 1 860.1650 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 HED MARC
has determined that for tolerance assessment and risk assessment, parent
only is the residue of concern (Memo, G. Kramer et al., 03-FEB-2004;
D297646).  Based on the results of the confined rotational crop study,
the appropriate PBI for all non-labeled crops is 30 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.  

 accumulate at ≥0.05 ppm (LOQ) in/on rotated turnip roots and wheat
straw planted ~30, 60, or 90 days following treatment of primary crops
at 0.9-1X the maximum seasonal rate.  No additional field rotational
crop data will be required as the current and proposed labels include a
restriction that only registered crops may be rotated to a treated field
within 30 days of the final application.

860.1550 Proposed Tolerances

HED has determined that the residue of concern in plants for tolerance
enforcement is novaluron only.  The proposed tolerance expression for
petition number 9E7546 is written in terms of “tolerances for combined
residues of the insecticide novaluron,
1-[3-chloro-4(1,1,2-trifluoro-2-trifluoro-methoxyethoxy)phenyl]-3-(2,6-d
ifluorobenzoyl)urea.”  A revised Section F should be submitted to
remove the word combined and cite the appropriate CAS name for
novaluron:

“Tolerances are established for residues of the insecticide novaluron,
including its metabolites and degradates, in or on the commodities in
the table below.  Compliance with the tolerance levels specified below
is to be determined by measuring only novaluron
(N-[[[3-chloro-4-[1,1,2-trifluoro-2-(trifluoromethoxy)ethoxy]phenyl]amin
o]carbonyl]-2,6-difluorobenzamide) in or on the following raw
agricultural commodities:”

A summary of the recommended tolerances for the current petition are
listed in Table 20.  A revised Section F is requested which reflects the
recommended tolerances and commodity definitions presented in Table 20. 
HED notes that cocona, African eggplant, pea eggplant, scarlet eggplant,
goji berry, garden huckleberry, martynia, naranjilla, okra, roselle,
sunberry, bush tomato, currant tomato, and tree tomato residue data have
not been submitted and concludes that the fruiting vegetable crop group
8 tolerance (1.0 ppm) may be translated to the proposed commodities (see
Reviewer's Guide and Summary of HED ChemSAC Approvals for Amending
Commodity Definitions (40 CFR 180.1(h)) and Crop Group/Subgroups (40 CFR
180.41)).  

No Codex, Canadian, or Mexican MRLs have been established for novaluron
in/on the proposed commodities.  Canada is currently in the process of
reviewing the use of novaluron on strawberries, snap beans, and bell and
non-bell peppers.  EPA and PMRA tolerance recommendations have been
harmonized at 0.45 ppm for low-growing berry subgroup 13-07G and 0.60
for edible-podded snap beans.  The PMRA has not received petitions for
the use of novaluron on fruiting vegetable group 8 and will be setting
tolerances for bell and non-bell peppers at 0.80 ppm and 0.90 ppm,
respectively (personal communication with Melissa Watchorn of PMRA,
30-NOV-2009).

The Agency’s Guidance for Setting Pesticide Tolerances Based on Field
Trial Data was utilized for determining appropriate tolerance levels;
see Appendix I for tolerance calculations.

Notes to RD:  The currently established tomato tolerance and the
time-limited tolerance for strawberry should be removed from 40 CFR
§180.598.  Additionally, the pending tolerance for bushberry subgroup
13-07B (7.0 ppm) should be amended to “bushberry subgroup 13-07B,
except lowbush blueberry.”

Table 20.  Tolerance Summary for Novaluron.

Commodity	Proposed Tolerance (ppm)	HED Recommended Tolerance (ppm)
Comments; 

Correct Commodity Definition

Vegetable, fruiting, group 8	1.1	1.0  

	Vegetable, cucurbit, group 9	0.25	0.15  

	Berry, low growing, subgroup 13-07G	0.50	0.45  	Berry, low-growing,
subgroup 13-07G

Cocona		1.1	1.0  

	Eggplant, African		1.1	1.0  

	Eggplant, pea		1.1	1.0  

	Eggplant, scarlet	1.1	1.0  

	Goji berry		1.1	1.0  

	Huckleberry, garden		1.1	1.0  

	Martynia		1.1	1.0  

	Naranjilla	1.1	1.0  

	Okra		1.1	1.0  

	Roselle		1.1	1.0  

	Sunberry	1.1	1.0  

	Tomato, bush	1.1	1.0  

	Tomato, currant	1.1	1.0  

	Tomato, tree	1.1	1.0  

	Bean, snap, succulent		0.60	0.60  

	Bean, dry	0.20	0.30  	Bean, dry, seed

Swiss chard		12	12  

	

References

  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

DP#s:		285474, 287627, 297094, 297228 & 298477

Subject:	PP#2F06430.  Novaluron.  Petition for the Establishment of
Permanent Tolerances for Use on Cotton, Pome Fruits, and Potato. 
Summary of Analytical Chemistry and Residue Data.

From:	G. Kramer

Date:	3/22/04

DP#:		306998

Subject:	PP#2F6430.  Novaluron in/on Cotton, Pome Fruit, and Potato. 
Results of the Petition Method Validation (PMV) of the Proposed
Analytical Enforcement Methods for Plant and Livestock Raw Agricultural
Commodities (RACs).

From:	S. Levy

Date:	09/15/04

DP#:		315890

Subject:	PP#2F06430.  Novaluron on Cotton, Pome Fruits, and Potato. 
Review of Amendment Dated 9/28/04 Submitted in Response to HED’s Memo
of 3/22/04.  Submission of Additional Information for the Dairy Cattle
Feeding Study. 

From:	G. Kramer

Date:	5/10/05

MRIDs:	46374101

DP#s:		322978 & 315780

Subject:	Novaluron.  Petitions for the Establishment of Permanent
Tolerances for Use on Brassica, head and stem, subgroup 5A (PP#4E6834)
and Label Amendment for New Use on Pome Fruit (PP#2F6430).  Summary of
Analytical Chemistry and Residue Data.

From:	S. Levy

Date:	11/3/05

DP#:		325183

Subject:	PP#4E6834.  Novaluron on Brassica, Head and Stem, Subgroup 5A. 
Review of Amendment Dated 15-Dec-2005 Submitted in Response to HED’s
Memo of 03-NOV-2005.  Submission of Additional Plant and Livestock
Radiovalidation Data.

From:	S. Levy

Date:	08/23/06

DP#s:		340137 & 342004

Subject:	Novaluron.  Petition for the Establishment of Permanent
Tolerances for New Uses on Sugarcane and Tomato (PP#7E7199); and Request
for Amended Use Pattern on Head and Stem Brassica Vegetables.  Summary
of Analytical Chemistry and Residue Data.

From:	G. Kramer

Date:	02/07/08

  SEQ CHAPTER \h \r 1 Attachments:  

International Residue Limit Status sheet

Appendix I - Tolerance-Assessment Calculations

cc:  Julie L. Van Alstine (RAB1) 

RDI:  G. Kramer (03-NOV-09), RAB1 Chemists (04-NOV-09)

J.L.Van Alstine:S10954:PY-S:(703)603-8866:7509P:RAB1

Template Version September 2005



INTERNATIONAL RESIDUE LIMIT STATUS

Chemical Name: 

N-[[[3-chloro-4-[1,1,2-trifluoro-2-(trifluoromethoxy)ethoxy]phenyl]amino
]carbonyl]-2,6-difluorobenzamide	Common Name:

Novaluron

	X Proposed tolerance

 Reevaluated tolerance

 Other	Date:  09/18/09

Codex Status (Maximum Residue Limits)	U. S. Tolerances

 No Codex proposal step 6 or above

 No Codex proposal step 6 or above for the crops requested	Petition
Numbers:  9E7546

DP#:  D364237

Other Identifier: Decision Numbers:  PC Code:  124002; Decision Number: 
407555

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

	Residue definition:  Novaluron only

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

Tomato	0.02 (*)	Vegetable, fruiting, group 8	1.1

Vegetable, cucurbit, group 9	0.25

Berry, low-growing, subgroup 13-07G	0.5

Cocona	1.1

Eggplant, African	1.1

Eggplant, pea	1.1

Eggplant, scarlet	1.1

Goji berry	1.1

Huckleberry, garden	1.1

Martynia	1.1

Naranjilla	1.1

Okra	1.1

Roselle	1.1

Sunberry	1.1

Tomato, bush	1.1

Tomato, currant	1.1

Tomato, tree	1.1

Bean, snap, succulent	0.60

Bean, dry	0.20

Swiss chard	12

Limits for Canada	Limits for Mexico

 No Limits

 No Limits for the crops requested	 No Limits

√  No Limits for the crops requested

Residue definition: 

N-[[[3-chloro-4-[1,1,2-trifluoro-2-(trifluoromethoxy)
ethoxy]phenyl]amino]carbonyl]-2,6-difluorobenzamide

	Residue definition:  novaluron

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

	Notes/Special Instructions:  

S.Funk, 10/16/2009.

* = absent at or about the limit of quantitation.

Appendix I.  Tolerance-Assessment Calculations.

Bell and Non-Bell Peppers (Fruiting Vegetables Crop Group 8)

The dataset used to establish a tolerance for novaluron in/on fruiting
vegetable group 8 consisted of field trial data for the representative
crops, tomatoes (previously submitted; Memo, G. Kramer, 7-FEB-2008;
D379033) and bell and non-bell peppers (current petition).  The bell
pepper field trial data represented application rates of 0.234-0.244 lb
ai/A (3 applications at 0.077-0.084 lb ai/A per application) with a 1-
to 2-day PHI.  The non-bell pepper field trial data represented
application rates of 0.240-0.245 lb ai/A (3 applications at 0.080-0.082
lb ai/A per application) with a 1-day PHI.  As specified by the Guidance
for Setting Pesticide Tolerances Based on Field Trial Data (SOP), the
field trial application rates and PHIs are within 25% of the maximum
label application rate and minimum label PHI, respectively.  The residue
values that were entered into the tolerance spreadsheet are provided in
Tables I.1 and I.2.

As 3 of the 18 bell pepper field trial sample results and 4 of the 8
non-bell pepper field trial sample results were below the LLMV of 0.05
ppm, MLE procedures were needed to impute censored values.  

The novaluron bell and non-bell pepper datasets were entered into the
tolerance spreadsheet as specified by the Guidance for Setting Pesticide
Tolerances Based on Field Trial Data SOP.  Visual inspection of the
lognormal probability plots (Figures I.1; I.3) and the results from the
approximate Shapiro-Francia test statistics (Figures I.2; I.4) indicated
that the datasets were reasonably lognormal.

Since the field trial data for novaluron in/on bell pepper represent a
large dataset (i.e., more than 15 samples) and are reasonably lognormal,
the minimum of the 95% upper-confidence limit (UCL) on the 95th
percentile and the point estimate of the 99th percentile should be
selected as the tolerance value.  Using the rounding procedure as
outlined in the SOP, the 95% UCL on the 95th percentile rounds to the
value 0.80 ppm and the point estimate of the 99th percentile rounds to
the value 0.80 ppm for bell peppers (Figure I.2).  Since the field trial
data for novaluron in/on non-bell peppers represent a small dataset
(i.e., less than 15 samples) and are reasonably lognormal, the minimum
of the 95% UCL on the 95th percentile and the point estimate of the 99th
percentile should be selected as the tolerance value.  Using the
rounding procedure as outlined in the SOP, the median 95th UCL rounds to
0.90 ppm for non-bell peppers.  

Since a dataset on tomatoes was previously submitted (Memo, G. Kramer,
7-FEB-2008; D379033) and the recommended bell and non-bell pepper
tolerances are below the tomato tolerance (1.0 ppm), the recommended
tolerance for fruiting vegetable group 8 is 1.0 ppm.    

Table I.1.  Residue Data Used to Calculate Tolerance for Novaluron in/on
Bell Peppers.

Regulator:	EPA

Chemical:	Novaluron (0.83 EC Formulation) 

Crop:	Peppers(Bell)

PHI:	1-2 Days

App. Rate:	0.234-0.244 lb ai/A

Submitter:	IR-4

MRID Citation:	47705801

	Residues of Novaluron (ppm)

	0.05

	0.05

	0.13

	0.14

	0.07

	0.07

	0.28

	0.29

	0.07

	0.07

	0.21

	0.22

MLE	0.031243757

MLE	0.036140742

MLE	0.040824722

	0.05

	0.36

	0.37

Figure I.1.  Lognormal Probability Plot of Novaluron Field Trial Data
for Bell Peppers.

 

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

 

Table I.2.  Residue Data Used to Calculate Tolerance for Novaluron in/on
Non-Bell Peppers.

Regulator:	EPA

Chemical:	Novaluron (0.83 EC Formulation)

Crop:	Non-Bell Pepper

PHI:	1-2 Days

App. Rate:	0.240-0.245 lb ai/A

Submitter:	IR-4

MRID Citation:	47705801

	Residues of Novaluron (ppm)

	0.34

	0.36

MLE	0.007759286

MLE	0.01495195

MLE	0.023795016

MLE	0.035102208

	0.2

	0.2

Figure I.3.  Lognormal Probability Plot of Novaluron Field Trial Data
for Non-Bell Peppers.

 

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

 

Cucumber, Cantaloupe, and Summer Squash (Cucurbit Vegetables Crop Group
9)

The dataset used to establish a tolerance for novaluron in/on cucurbit
vegetables crop group 9 consisted of field trial data for the
representative crops, cucumber, muskmelon, and summer squash,
representing application rates of 0.230-0.249 lb ai/A (3 applications at
0.075-0.085 lb ai/A per application) with a 1-day PHI.  As specified by
the Guidance for Setting Pesticide Tolerances Based on Field Trial Data
(SOP), the field trial application rates and PHIs are within 25% of the
maximum label application rate and minimum label PHI, respectively.  The
residue values that were entered into the tolerance spreadsheet for
cantaloupe and summer squash are provided in Tables I.3 and I.4.  All
cucumber samples had residues below the LLMV (0.05 ppm), so the
tolerance spreadsheet was not used and the recommended cucumber
tolerance was 0.05 ppm.  

As 10 of the 16 cantaloupe field trial sample results and 11 of the 14
summer squash field trial sample results were below the LLMV of 0.05
ppm, MLE procedures were needed to impute censored values.  

The cantaloupe and summer squash datasets were entered into the
tolerance spreadsheet as specified by the Guidance for Setting Pesticide
Tolerances Based on Field Trial Data SOP.  Visual inspection of the
lognormal probability plots (Figures I.5; I.7) and the results from the
approximate Shapiro-Francia test statistics (Figures I.6; I.8) indicated
that the datasets were reasonably lognormal.

Since the field trial data for novaluron in/on cantaloupe represent a
large dataset (i.e., more than 15 samples) and are reasonably lognormal,
the minimum of the 95% UCL on the 95th percentile and the point estimate
of the 99th percentile should be selected as the tolerance value.  Using
the rounding procedure as outlined in the SOP, the 95% UCL on the 95th
percentile rounds to the value 0.15 ppm and the point estimate of the
99th percentile rounds to the value 0.15 ppm (Figure I.6).  Since the
field trial data for novaluron on summer squash represent a small
dataset (i.e., less than 15 samples) and are reasonably lognormal, the
minimum of the 95% UCL on the 95th percentile and the point estimate of
the 99th percentile should be selected as the tolerance value.  Using
the rounding procedure as outlined in the SOP, the 95% UCL on the 95th
percentile rounds to the value 0.10 ppm and the point estimate of the
99th percentile rounds to the value 0.09 ppm (Figure I.8).  The
recommended tolerance for cucurbit vegetables crop group 9 is 0.15 ppm,
based on the cantaloupe field trial since it is the highest tolerance
for the crop group.  

Table I.3.  Residue Data Used to Calculate Tolerance for Novaluron in/on
Cantaloupe.

Regulator:	EPA

Chemical:	Novaluron (0.83 EC Formulation)

Crop:	Cantaloupe

PHI:	1 Day

App. Rate:	0.239-0.245 lb ai/A

Submitter:	IR-4

MRID Citation:	47705803

	Residues of Novaluron (ppm)

MLE	0.020

MLE	0.024

	0.051

MLE	0.027

	0.046

MLE	0.030

MLE	0.033

MLE	0.035

	0.093

	0.090

	0.081

MLE	0.038

MLE	0.041

	0.070

MLE	0.043

MLE	0.047

Figure I.5.  Lognormal Probability Plot of Novaluron Field Trial Data
for Cantaloupe.

 

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

 

Table I.4.  Residue Data Used to Calculate Tolerance for Novaluron in/on
Summer Squash.

Regulator:	EPA

Chemical:	Novaluron (0.83 EC Formulation) USING MLE

Crop:	Summer Squash

PHI:	1 Day

App. Rate:	0.240-0.249 lb ai/A

Submitter:	IR-4

MRID Citation:	47705804

	Residues of Novaluron (ppm)

MLE	0.021

MLE	0.024

MLE	0.027

MLE	0.029

MLE	0.031

MLE	0.033

MLE	0.035

MLE	0.038

	0.074

	0.067

	0.045

MLE	0.040

MLE	0.043

MLE	0.046

Figure I.7.  Lognormal Probability Plot of Novaluron Field Trial Data
for Summer Squash.

 

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

 

Strawberry (Low-growing Berry Crop Subgroup 13-07G)

The dataset used to establish a tolerance for novaluron in/on
low-growing berry crop subgroup 13-07G consisted of field trial data for
the representative crop, strawberry, representing application rates of
0.238-0.251 lb ai/A (3 applications at 0.077-0.084 lb ai/A per
application) with a 1-day PHI.  As specified by the Guidance for Setting
Pesticide Tolerances Based on Field Trial Data (SOP), the field trial
application rates and PHIs are within 25% of the maximum label
application rate and minimum label PHI, respectively.  The residue
values that were entered into the tolerance spreadsheet are provided in
Table I.5.

The novaluron strawberry dataset was entered into the tolerance
spreadsheet as specified by the Guidance for Setting Pesticide
Tolerances Based on Field Trial Data SOP.  All 20 field trial sample
results were above the LLMV (0.05 ppm).  Visual inspection of the
lognormal probability plot (Figure I.9) and the results from the
approximate Shapiro-Francia test statistic (Figure I.10) indicated that
the dataset was reasonably lognormal.

Since the field trial data for novaluron on strawberry represent a large
dataset (i.e., more than 15 samples) and are reasonably lognormal, the
minimum of the 95% UCL on the 95th percentile and the point estimate of
the 99th percentile should be selected as the tolerance value.  Using
the rounding procedure as outlined in the SOP, the 95% UCL on the 95th
percentile rounds to the value 0.45 ppm and the point estimate of the
99th percentile rounds to the value 0.45 ppm (Figure I.10).  Therefore,
0.45 ppm is the recommended tolerance level for novaluron in/on growing
berry crop subgroup 13-07G.  

Table I.5.  Residue Data Used to Calculate Tolerance for Novaluron in/on
Strawberry.

Regulator:	EPA

Chemical:	Novaluron (0.83 EC Formulation)

Crop:	Strawberry

PHI:	1 Day

App. Rate:	0.238-0.251 lb ai/A

Submitter:	IR-4

MRID Citation:	47705805

	Residues of Novaluron (ppm)

	0.0500

	0.2870

	0.0685

	0.1140

	0.1890

	0.2190

	0.2380

	0.2610

	0.0500

	0.0682

	0.0737

	0.1240

	0.1180

	0.1760

	0.0970

	0.1070

	0.1670

	0.1810

	0.0948

	0.1080

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

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

Snap Beans

The dataset used to establish a tolerance for novaluron in/on snap beans
consisted of field trial data representing application rates of
0.236-0.263 lb ai/A (3 applications at 0.076-0.088 lb ai/A per
application) with a 2- to 3-day PHI.  As specified by the Guidance for
Setting Pesticide Tolerances Based on Field Trial Data (SOP), the field
trial application rates and PHIs are within 25% of the maximum label
application rate and minimum label PHI, respectively.  The residue
values that were entered into the tolerance spreadsheet are provided in
Table I.6.

The novaluron snap bean dataset was entered into the tolerance
spreadsheet as specified by the Guidance for Setting Pesticide
Tolerances Based on Field Trial Data SOP.  All 28 field trial sample
results were above the LLMV (0.05 ppm).  Visual inspection of the
lognormal probability plot (Figure I.11) and the results from the
approximate Shapiro-Francia test statistic (Figure I.12) indicated that
the dataset was reasonably lognormal.

Since the field trial data for novaluron in/on snap beans represent a
large dataset (i.e., more than 15 samples) and are reasonably lognormal,
the minimum of the 95% UCL on the 95th percentile and the point estimate
of the 99th percentile should be selected as the tolerance value.  Using
the rounding procedure as outlined in the SOP, the 95% UCL on the 95th
percentile rounds to the value 0.60 ppm and the point estimate of the
99th percentile rounds to the value 0.60 ppm (Figure I.12).  Therefore,
0.60 ppm is the recommended tolerance level for novaluron in/on snap
beans.  

Table I.6.  Residue Data Used to Calculate Tolerance for Novaluron in/on
Snap Beans.

Regulator:	EPA

Chemical:	Novaluron (0.83 EC Formulation)

Crop:	Snap Bean

PHI:	2-3 Days

App. Rate:	0.236-0.263 lb ai/A

Submitter:	IR-4

MRID Citation:	47705806

	Residues of Novaluron (ppm)

	0.400

	0.460

	0.088

	0.160

	0.160

	0.170

	0.160

	0.180

	0.096

	0.120

	0.240

	0.400

	0.310

	0.320

	0.050

	0.050

	0.096

	0.160

	0.094

	0.120

	0.170

	0.180

	0.160

	0.180

	0.140

	0.140

	0.090

	0.100

Figure I.11.  Lognormal Probability Plot of Novaluron Field Trial Data
for Snap Beans.

 

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

 

Swiss Chard

The dataset used to establish a tolerance for novaluron in/on Swiss
chard consisted of field trial data representing application rates of
0.237-0.243 lb ai/A (3 applications at 0.079-0.082 lb ai/A per
application) with a 1-day PHI.  As specified by the Guidance for Setting
Pesticide Tolerances Based on Field Trial Data (SOP), the field trial
application rates and PHIs are within 25% of the maximum label
application rate and minimum label PHI, respectively.  The residue
values that were entered into the tolerance spreadsheet are provided in
Table I.7.

The novaluron Swiss chard dataset was entered into the tolerance
spreadsheet as specified by the Guidance for Setting Pesticide
Tolerances Based on Field Trial Data SOP.  All 3 field trial sample
results were above the LLMV (0.05 ppm).  Visual inspection of the
lognormal probability plot (Figure I.13) and the results from the
approximate Shapiro-Francia test statistic (Figure I.14) indicated that
the dataset was reasonably lognormal.

Since the field trial data for novaluron in/on Swiss chard represent a
small dataset (i.e., less than 15 samples) and are reasonably lognormal,
the minimum of the 95% UCL on the 95th percentile and the point estimate
of the 99th percentile should be selected as the tolerance value.  Using
the rounding procedure as outlined in the SOP, the 95% UCL on the 95th
percentile rounds to the value 25 ppm and the point estimate of the 99th
percentile rounds to the value 12 ppm (Figure I.14).  Because the 12-ppm
value was the minimum value, 12 ppm is the recommended tolerance level
for novaluron in/on Swiss chard.  

Table I.7.  Residue Data Used to Calculate Tolerance for Novaluron in/on
Swiss Chard.

Regulator:	EPA

Chemical:	Novaluron (0.83 EC Formulation)

Crop:	Swiss Chard

PHI:	1 Day

App. Rate:	0.237-0.243 lb ai/A

Submitter:	IR-4

MRID Citation:	47705808

	Residues of Novaluron (ppm)

	2.200

	2.300

	6.400

	6.600

	3.600

	4.000

 

Figure I.13.  Lognormal Probability Plot of Novaluron Field Trial Data
for Swiss Chard.

 

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

 

Dry Beans

The dataset used to establish a tolerance for novaluron in/on dry beans
consisted of field trial data representing application rates of
0.237-0.249 lb ai/A (3 applications at 0.078-0.090 lb ai/A per
application) with a 1- to 2-day PHI (only 1 trial had a 2-day PHI).  As
specified by the Guidance for Setting Pesticide Tolerances Based on
Field Trial Data (SOP), the field trial application rates and PHIs are
within 25% of the maximum label application rate and minimum label PHI,
respectively.  The residue values that were entered into the tolerance
spreadsheet are provided in Table I.8.

As 21 of the 26 bell pepper field trial sample results were below the
LLMV of 0.05 ppm, MLE procedures were needed to impute censored values. 

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Since the field trial data for novaluron on dry bean represent a large
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minimum of the 95% UCL on the 95th percentile and the point estimate of
the 99th percentile should be selected as the tolerance value.  Using
the rounding procedure as outlined in the SOP, the 95% UCL on the 95th
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99th percentile rounds to the value 0.30 ppm (Figure I.16).  Therefore,
0.30 ppm is the recommended tolerance level for novaluron in/on dry
bean.  

Table I.8.  Residue Data Used to Calculate Tolerance for Novaluron in/on
Dry Beans.

Regulator:	EPA

Chemical:	Novaluron (0.83 EC Formulation)

Crop:	Dry Bean

PHI:	1 Day (one trial--2 days)

App. Rate:	0.237-0.249 lb ai/A

Submitter:	IR-4

MRID Citation:	47705807

	Residues of Novaluron (ppm)

MLE	0.002

MLE	0.003

MLE	0.004

MLE	0.004

MLE	0.005

MLE	0.006

MLE	0.007

MLE	0.008

MLE	0.010

MLE	0.011

MLE	0.012

MLE	0.014

	0.052

	0.058

	0.360

	0.082

MLE	0.015

MLE	0.017

MLE	0.020

MLE	0.022

MLE	0.025

MLE	0.028

MLE	0.032

	0.078

MLE	0.037

MLE	0.042

Figure I.15.  Lognormal Probability Plot of Novaluron Field Trial Data
for Dry Beans.

 

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

 

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

 PAGE   

Page   PAGE  24  of   NUMPAGES  43