Document ID: EPA-HQ-OPP-2008-0769-0007
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2009-12-09T05:00Z

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, D.C.  20460

	OFFICE OF PREVENTION, PESTICIDES,

	AND TOXIC SUBSTANCES

  SEQ CHAPTER \h \r 1 MEMORANDUM

Date:		09-SEP-2009

SUBJECT:	Novaluron.  Petition for the Establishment of Permanent
Tolerances for Residues of Novaluron in/on Bushberry Subgroup 13-07B;
Brassica, Leafy Greens, Subgroup 5B; Turnip, Greens; and Fruit, Stone,
Group 12.  Summary of Analytical Chemistry and Residue Data.

PC Code:  124002	DP Barcode:  D357060

Decision No.:  399484 	Registration No.:  66222-35

Petition No.:  8E7425	Regulatory Action:  Amended Section 3

Risk Assessment Type:  NA	Case No.:  NA

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

MRID Nos.:  47526901; 47526902; 47526903; 47526904; 47526905	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:		Daniel Rosenblatt/Laura Nollen (RM 05)  SEQ CHAPTER \h \r 1   SEQ
CHAPTER \h \r 1 

		Registration Division (RD; 7505P)

  SEQ CHAPTER \h \r 1 This document was originally prepared under
contract by Dynamac Corporation (2275 Research Boulevard, Suite 300;
Rockville, MD 20850).  The document has been reviewed by HED and revised
to reflect current Office of Pesticide Programs (OPP) policies.

Executive Summary

Novaluron, a benzoylphenyl urea compound, is a pesticide chemical
belonging to the class of insecticides called insect-growth regulators
(IGR).  It is currently registered for uses on pome fruits, Brassica
head and stem vegetables, tuberous and corm vegetables, cotton,
tomatoes, and sugarcane.  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).

The Interregional Research Project No. 4 (IR-4), on behalf of the
Agricultural Experiment Stations of FL, ME, MI, NJ, OR, PA, and WA,
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:

Bushberry subgroup 13-07B	7.0 ppm

Concurrently, IR-4, on behalf of the Agricultural Experiment Stations of
CA, DE, FL, GA, MI, MS, NJ, NC, OK, OR, PA, SC, TN, UT, and WA, 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:

Brassica, leafy greens, subgroup 5B	25 ppm

Turnip, greens	25 ppm

Fruit, stone, group 12	8.0 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 three foliar spray applications on members of the bushberry subgroup
13-07B at a maximum seasonal rate of 0.58 lb ai/A with an 8-day
preharvest interval (PHI) using ground or aerial equipment.  For
Brassica, leafy greens, subgroup 5B and turnip greens, three
applications of Rimon® at a seasonal rate of 0.23 lb ai/A with a 7-day
PHI using ground or aerial equipment is proposed.  Three applications of
Rimon® is proposed for fruit, stone, group 12, at a maximum seasonal
rate of 0.97 lb ai/A with an 14-day PHI with ground equipment.  A
revised Section B is requested which prohibits the use of novaluron on
turnips harvested for the root and prohibits the feeding of turnip tops
to livestock.  

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.  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 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).

Turnip varieties which produce a harvestable root are members of crop
group 2, for which tolerances are neither established nor proposed.  A
revised Section B is thus requested which specifies that the use of
novaluron on dual purpose turnip cultivars or varieties which produce a
harvestable root is prohibited.  Based on the most recent Table 1 of
OPPTS Test Guideline 860.1000 [Memo, Chemistry Science Advisory Council
(ChemSAC), 30-Jun-2008], and provided a revised Section B is submitted,
there are no feed commodities associated with the current petition. 
Therefore, a discussion of the nature of the residue in livestock is
unnecessary.  

Bushberries and stone fruit are typically not rotated; however, Brassica
leafy greens and turnip greens may be rotated.  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 blueberry,
mustard greens, and peach field studies.  The method was adequately
validated in conjunction with the blueberry, mustard greens, and peach
studies; the validated limits of quantitation (LOQs) were 0.05 ppm, 0.03
ppm, and 0.058 ppm, respectively.  Cherry samples were analyzed using a
method based on Pyxant Labs Inc. mass spectrometry (MS) method number
METH1585-00.00, entitled “Magnitude of the Residue of Novaluron in
Crop Matrices by LC/MS/MS.”  Fresh and dried plum samples were
analyzed using Pyxant Labs Inc. analytical method number STM1585.01,
“Analytical Method for the Determination of Novaluron in Crop Matrices
by LC/MS/MS,” a method which is similar to the method used to analyze
the cherry samples.  Neither method has been previously reviewed;
however, the methods are similar to the GC/ECD enforcement method.  The
method was adequately validated in conjunction with the cherry and plum
studies.  The LOQs for cherries and fresh and dried plums were 0.05 ppm,
0.03 ppm, and 0.05 ppm, respectively.  

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 blueberry,
mustard greens, and peach field trial studies.  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, and tomatoes.  In addition, concurrent storage
stability data were submitted confirming the stability of novaluron
residues in/on blueberry stored frozen for up to 150 days, mustard
greens stored frozen for up to 464 days, and peaches stored frozen for
up to 116 days.  

Concurrent storage stability data for cherries and fresh and dried plums
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 cherry and fresh plum storage, pome fruits (apple),
fruiting vegetables (tomato), and stone fruits all 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 tomato and apple may be extended to cherries and fresh
plums for the purpose of these residue trials.  There are no concerns
with the stability of residues in cherries and fresh plums for these
studies; however, no suitable freezer storage stability data have been
submitted to support the frozen storage interval of dried plums in this
study.  Therefore, the processed food data for dried plums are
classified as scientifically acceptable pending submission of freezer
storage stability data for residues in/on dried plums.  

The submitted field trial residue data for blueberry, mustard greens,
cherries, peaches, and plums are adequate to support the establishment
of the requested crop/subgroup tolerance.  The number and locations of
field trials are in accordance with OPPTS Guideline 860.1500 for
blueberry, mustard greens, and peaches, plums, and cherries, as the
representative crops of the bushberry subgroup 13-07B, Brassica, leafy
greens, subgroup 5B, and fruit, stone, group 12, respectively.  The
trials conducted reflect the proposed maximum seasonal rate and PHI. 
The maximum residue of novaluron was 3.81 ppm in/on 18 samples of
blueberry harvested 6 to 8 days following the last of three foliar spray
treatments with Rimon® 0.83 EC Insecticide at a total rate of
0.547-0.577 lb ai/A (~1x the proposed maximum seasonal rate).  For
mustard greens, the maximum residue of novaluron was 14.56 ppm in/on 22
samples of mustard greens harvested at 3 to 4 days following the last of
three foliar applications of Rimon® 0.83 EC without a crop oil
concentrate (COC) at a total rate of 0.233-0.251 lb ai/A (~1x the
proposed maximum seasonal rate).  For mustard greens treated with three
applications of Rimon® 0.83 EC and a COC at a total rate of 0.239-0.242
lb ai/A (~1x the proposed maximum seasonal rate), the maximum residue
was 18.54 ppm in/on 6 samples of mustard greens harvested 3 days after
the last application of novaluron.  For peaches, the maximum residue of
novaluron was 2.10 ppm in/on 30 samples harvested 6 to 7 days following
the last of three foliar applications of Rimon® 0.83 EC Insecticide at
a total rate of 0.98 to 1.04 lb ai/A (~1x the proposed maximum seasonal
rate).  The maximum residue of novaluron was 4.08 ppm in/on 14 samples
of cherries harvested 7 days after the third and final application of
Novaluron 10EC which was applied at rates of 1.00 to 1.02 lb ai/A (~1x
the proposed maximum seasonal rate).  For fresh plums, the maximum
residue of novaluron was 0.803 ppm in/on 20 samples harvested 6 to 8
days following the last of three foliar applications of Rimon® 0.83 EC
Insecticide at a total rate of 1.00 to 1.02 lb ai/A (~1x the proposed
maximum seasonal rate).  

For the plum processing study, the maximum residue of novaluron was
0.410 ppm in/on 2 samples harvested 8 days following the last of three
foliar applications of Rimon® 0.83 EC Insecticide at a total rate of
1.00 to 1.02 lb ai/A (~1x the proposed maximum seasonal rate).  Dried
plum samples were collected after the weight of the plums had declined
by a factor of ~2.8 (fresh weight/2.8).  No detectable residues were
found in/on treated dry plums from the CA17 trial.  It was reported that
possible mislabeling of sample bags may have occurred in the CA17 trial.
 Therefore given the uncertainty regarding samples taken from trial
CA17, results from this trial are deemed invalid.  Residues of novaluron
in/on treated dry plums were 1.39 ppm in the CA14 trial, indicating a
concentration factor of 3.39x for this processed commodity.  The maximum
theoretical concentration factor for the processing of fresh plums to
dry plums is 5.0x.

The field trial data were entered into the Agency’s tolerance
spreadsheet to determine an appropriate tolerance level.  The output
from the spreadsheet supports the IR-4 proposed tolerance of 7.0 ppm for
residues of novaluron in/on bushberry subgroup 13-07B and 25 ppm for
residues of novaluron in/on Brassica, leafy greens, subgroup 5B and
turnip, greens.  The tolerance spreadsheet output did not support
IR-4’s proposal for 8.0 ppm for residues of novaluron in/on fruit,
stone, group 12; the appropriate tolerances are 8.0 ppm for cherry, 1.9
ppm for fruit, stone, group 12, except cherry, and 2.6 ppm for dried
plums.  

No Codex, Canadian, or Mexican maximum residue limits (MRLs) have been
established for novaluron on bushberries, Brassica, leafy greens, turnip
greens, and stone fruit.  Canada is currently in the process of
reviewing the use of novaluron on Brassica, leafy greens, subgroup 5B
and fruit, stone, group 12.  EPA and PMRA tolerance recommendations have
been harmonized at 7.0 ppm for Brassica, leafy greens, subgroup 5B, 1.9
ppm for fruit, stone, group 12, except cherry, 8.0 ppm for cherry, and
2.6 ppm for dried plums (personal communication with Monica Le of PMRA,
28-AUG-2009).  

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

Pending submission of revised Sections B and F, there are no residue
chemistry issues that would preclude granting an unconditional
registration for the requested use of novaluron on bushberries,
Brassica, leafy greens, and turnip greens, or the establishment of the
tolerances for novaluron residues listed below:    SEQ CHAPTER \h \r 1 

Bushberry subgroup 13-07B	7.0 ppm

Brassica, leafy greens, subgroup 5B	25 ppm

Turnip, greens	25 ppm

Fruit, stone, group 12, except cherry	1.9 ppm

Cherry	8.0 ppm

Plum, prune, dried	2.6 ppm

Additional storage stability data needs to be submitted before the
residue chemistry database will support an unconditional registration
for the requested use of novaluron on stone fruit.  

A human-health risk assessment is forthcoming in a separate document
(D357078).

860.1200 Directions for Use

A revised section B should be submitted which:

specifies a PHI for the use of novaluron on “Peach Twig Borers”;

updates “chines (bok choy)” to “Chinese (bok choy)” in the
foliar feeding insects controlled by Rimon® on “Leafy Brassica
Greens” section; 

prohibits the use of novaluron on turnips harvested for the root and
prohibits the feeding of turnip tops to livestock; and

includes a statement in the “Stone Fruit,” “Bushberries,”
“Leafy Brassica Greens,” and “Turnip Greens” sections which
states that the use of adjuvants on these commodities is prohibited.

860.1380 Storage Stability Data

Storage stability data on dried plums for up to 243 days (~8 months) are
required.  

860.1550 Proposed Tolerances

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:”

In addition, the proposed tolerances should be revised to reflect the
correct commodity definitions and the HED recommend tolerances as
specified in Table 10.

Note to RD:  40 CFR §180.598 should also be amended to correct the
commodity “Vegetables, tuberous and corn, subgroup 1C” to
“Vegetable, tuberous and corm, subgroup 1C.”  Also, the existing
tolerance for residues of novaluron in/on eggs should be increased from
0.05 ppm to 0.07 ppm (Memo, S. Levy, 31-JAN-08; DP# 340137).

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)

 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 19-SEP-2008, for Rimon® 0.83 EC
Insecticide (EPA Reg. No. 66222-35) to include the proposed new use (see
Table 3) on the bushberry subgroup, Brassica, leafy greens subgroup,
turnip greens, and stone fruit group.

Table 3.  Summary of Directions for Use of Novaluron.

Applic. Timing, Type, and Equip.	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

Bushberries [Bushberry Subgroup:  Aronia berry; blueberry, highbush;
blueberry, lowbush; buffalo currant; Chilean guava; cranberry, highbush;
currant, black; currant, red; elderberry; European barberry; gooseberry;
honeysuckle, edible; huckleberry; jostaberry; Juneberry (Saskatoon
berry); ligonberry; native currant; salal; sea buckthorn; cultivars,
varieties, and/or hybrids of these]

Foliar;

Ground/aerial	0.83 lb/gal EC

[66222-35]	0.13-0.19	3	0.58	8	Reapplication may be made with a minimum
10-day interval.  

Brassica, Leafy Greens [Brassica, Leafy Greens Subgroup: broccoli raab,
cabbage, Chinese (bok choy), collards, kale, mizuna, mustard greens,
mustard spinach, and rape greens]

Foliar; Ground/aerial	0.83 lb/gal EC

[66222-35]	0.04-0.08	3	0.23	7	Reapplication may be made with a minimum
7-day interval.

Turnip Greens

Foliar; Ground/aerial	0.83 lb/gal EC

[66222-35]	0.04-0.08	3	0.23	7	Reapplication may be made with a minimum
7-day interval.

Stone Fruit

Conventional ground sprayers	0.83 lb/gal EC

[66222-35]	0.13-0.32 (Eastern USA)

0.19-0.32 (Western USA)	3	0.97	81; 142	Reapplication may be made with a
minimum 14-day interval for oriental fruit moth.   Reapplication may be
made with a minimum 10-day interval for oliquebanded leafroller,
fruittree leafroller, omnivorus leafroller.  

1 For oliquebanded leafroller, fruittree leafroller, omnivorus
leafroller on stone fruit.

2 For oriental fruit moth on stone fruit.

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.  Rimon® may be applied alone, as a
tankmix, or in rotation with other registered insecticides.  COC should
not be used as an additive for the Brassica, leafy greens subgroup and
turnip greens.  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.

Conclusions:  The proposed label is adequate to allow evaluation of the
residue data relative to the proposed new uses on bushberry subgroup
13-07B, Brassica, leafy greens, subgroup 5B, turnip, greens, and fruit,
stone, group 12.  However, a revised section B needs to be submitted
which:  specifies a PHI for the use of novaluron on “Peach Twig
Borers”; updates “chines (bok choy)” to “Chinese (bok choy)”
in the foliar feeding insects controlled by Rimon® on “Leafy Brassica
Greens” section; prohibits the use of novaluron on turnips harvested
for the root and prohibits the feeding of turnip tops to livestock; and
includes a statement in the “Stone Fruit,” “Bushberries,”
“Leafy Brassica Greens,” and “Turnip Greens” sections which
states that the use of adjuvants on these commodities 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 (3-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

Based on the most recent Table 1 of OPPTS Test Guidelines 860.1000
[Memo, ChemSAC, 30-JUN-2008], and provided a revised Section B is
submitted which prohibits the use of novaluron on turnips harvested for
the root and prohibits the feeding of turnip tops to livestock, there
are no feed commodities associated with the current petition. 
Therefore, a discussion of the nature of the residue in livestock is
unnecessary.    

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 a NH2-SPE (solid-phase extraction)
cartridge, the eluate is evaporated to dryness, and residues are
redissolved in ethyl acetate or hexane for analysis by GC/ECD.  The
validated LOQs are 0.01 ppm 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 DP# 325183 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 (DP#
306998).  Both methods have been forwarded to the FDA for inclusion in
the PAM II as a Letter Method (DP# 307595).

Blueberry Data-collection:  Samples of blueberry from the field trial
studies were analyzed for residues of novaluron using the GC/ECD
enforcement method.  Briefly, blueberries were extracted with
methanol:water (70:30, v:v), filtered and partitioned into ethyl acetate
followed by cleanup through a NH2-SPE column.  Residues of novaluron
were quantitated by GC/ECD.

Adequate method verification and concurrent method recovery data were
provided in conjunction with the submitted blueberry field trials. 
Fortification levels (0.05-5.0 ppm) in the method validation adequately
encompassed the expected residues in/on blueberry.  The lowest level of
method validation (LLMV) was 0.05 ppm for residues in/on blueberry.

Mustard Green Data-collection:  Samples of mustard greens from the field
trial studies were analyzed for residues of novaluron using the GC/ECD
enforcement method.  Briefly, mustard greens were extracted with
methanol:water (70:30, v:v), filtered and partitioned into hexane
followed by cleanup through a NH2-SPE column.  Residues of novaluron
were quantitated by GC.

Adequate method verification and concurrent method recovery data were
provided in conjunction with the submitted mustard green field trials. 
Fortification levels (0.05-20.0 ppm) in the method validation adequately
encompassed the expected residues in/on mustard greens.  The LLMV was
0.05 ppm for residues in/on mustard greens.

Peach Data-collection:  Samples of peach from the field trial studies
were analyzed for residues of novaluron using the GC/ECD method
“Residue Analysis of Novaluron on Peach by GC/EC Detection, Version
#1” which is similar to the GC/ECD enforcement method.  Briefly,
peaches were homogenized with methanol:water (70:30, v:v), filtered and
partitioned into hexane followed by cleanup through a NH2-SPE column. 
Residues of novaluron were quantitated by GC/ECD.

Adequate method verification and concurrent method recovery data were
provided in conjunction with the submitted mustard green field trials. 
Fortification levels (0.05-5.0 ppm) in the method validation adequately
encompassed the expected residues in/on peaches.  The LLMV was 0.05 ppm
for residues in/on peaches.

Plum Data-collection:  Samples of fresh and dried plums from the field
trial studies were analyzed for residues of novaluron using Pyxant Labs
Inc. analytical method number STM1585.01, “Analytical Method for the
Determination of Novaluron in Crop Matrices by LC/MS/MS
(liquid-chromatography with tandem mass-spectrometric detection),” a
method very similar to the enforcement method, Pyxant Labs Inc.
analytical method number METH1585-00.00, used to analyze residues of
novaluron in cherries.  Neither method has been previously reviewed,
however the methods are similar to the GC/ECD method previously proposed
for enforcement purposes.  Briefly, fresh and dried plum samples were
macerated with a homogenizer in the presence of methanol:water (70:30,
v:v), filtered and then the extract was diluted with methanol:water
(70:30, v:v).  Residues of novaluron were quantitated by LC/MS/MS.

Adequate method verification and concurrent method recovery data were
provided in conjunction with the submitted plum field trials. 
Fortification levels (0.05-5.0 ppm) in the method validation adequately
encompassed the expected residues in/on plums.  The LLMV was 0.05 ppm
for residues in/on fresh and dried plums.

Cherry Data-collection:  Samples of cherries from the field trial
studies were analyzed for residues of novaluron using Pyxant Labs Inc.
analytical method number METH1585-00.00, entitled “Magnitude of the
Residue of Novaluron in Crop Matrices by LC/MS/MS.”  The method has
not been previously reviewed, however it is similar to the GC/ECD method
previously proposed for enforcement purposes.  Briefly, cherry samples
were macerated with a homogenizer in the presence of methanol:water
(70:30, v:v), filtered, dried, and then the extract was diluted with
methanol:water (70:30, v:v).  Residues of novaluron were quantitated by
LC/MS/MS.

Adequate method verification and concurrent method recovery data were
provided in conjunction with the submitted cherry field trials. 
Fortification levels (0.05-5.0 ppm) in the method validation adequately
encompassed the expected residues in/on cherries.  The LLMV was 0.05 ppm
for residues in/on cherries.

Conclusions:  HED previously concluded that the submitted GC/ECD method
is adequate as an enforcement method for novaluron, the terminal residue
of concern in plants (apple, cabbage, cotton, and potato).  The
enforcement method, with minor modifications, was used for data
collection and the method was adequately validated in conjunction with
the blueberry, mustard green, and peach field trials associated with the
new use discussed herein.  A method similar to the enforcement method
was used for data collection for the plum and cherry field trials and
the method was adequately validated in conjunction with the field
trials.

 

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, 3/22/04, G.F. Kramer (PP#2F6430)

Storage stability data for novaluron were presented in PP#2F6430.  These
data show that fortified residues of novaluron are reasonably stable
under frozen conditions in/on pears for up to 5.2 months; broccoli,
cabbage, and tomato for up to 6 months; apple and potato for up to 12
months; and apple juice for up to 3.3 months.

In conjunction with the subject blueberry, mustard green, and peach
field trial studies, concurrent storage stability data were generated
which further demonstrate 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.  Although no 0-day data were provided with the concurrent
storage stability data, no additional data will be required in
consideration of the stability of novaluron in/on other crop matrices.

Concurrent freezer storage stability data were not generated for the
cherry and fresh plum residue trials.  Current Agency regulatory
guidelines require that stability of residues for the duration of
storage be shown either in the requested crops (or representative crops)
or in at least five diverse crops.  While freezer storage stability data
are not on file for any representative stone fruit for the duration of
cherry or fresh plum storage or five diverse crops, pome fruits (apple),
fruiting vegetables (tomato), and stone fruits all 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 cherries and fresh
plums for the purpose of these residue trials.  While there are no
concerns with the stability of residues in/on cherries and fresh plums,
there are no suitable freezer storage stability data on file to support
the frozen storage interval of dried plums.  For dried plums, the
processed food data are classified as scientifically acceptable pending
submission of freezer storage stability data for dried plums.

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

Blueberry	-38 to -0.2	87-145 days

(2.9-4.8 months)	Up to 150 days for residues of novaluron in/on frozen
blueberries (concurrent storage stability data).

Mustard Greens	<-5	464 days 

(15.3 months)	Up to 464 days for residues of novaluron in/on frozen
mustard greens (concurrent storage stability data).

Peaches	-21 ± 7	116 days

≤ -20	5071 

(16.7 months)	Freezer storage stability data for novaluron are on file
for tomato and apple (PMRA# 883983, PMRA# 889382; reviewed with
S2002-1795).  The studies indicated that these residues are stable in/on
these matrices when stored at -18oC for 12 months in both apples and
tomatoes.  This storage stability data may be extended to fresh plums.  

Dried Plums	≤ -20	209-243 days

(6.9-8.0 months)	None.

Cherries	-30 to -9	287-363 days

(9.4-11.9 months)	Freezer storage stability data for novaluron are on
file for tomato and apple (PMRA# 883983, PMRA# 889382; reviewed with
S2002-1795).  The studies indicated that these residues are stable in/on
these matrices when stored at -18oC for 12 months in both apples and
tomatoes.  This storage stability data may be extended to cherries.  

1 Except for plum samples from the CA18 trial, all samples were analyzed
within 1 year of the sampling date.

Conclusions:  In conjunction with previously submitted storage stability
data for novaluron on a variety of crops, the concurrent storage
stability conducted with the blueberry, mustard green, and peach 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 cherries and fresh plums for the purpose of these
residue trials.  Freezer storage stability data on dried plums is
required.  

860.1480 Meat, Milk, Poultry, and Eggs

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

860.1500 Crop Field Trials

Blueberry

DER References:  47526901.der.doc

Nine blueberry trials were conducted in the U.S. in North American Free
Trade Agreement (NAFTA) Growing Zones 1 (ME; 1 trial), 2 (GA, NJ, NC; 4
trials), 5 (MI; 3 trials), and 12 (OR; 1 trial) during the 2005 growing
season.  Each trial site consisted of one untreated plot and one treated
plot.  The test formulation used in the trials was Rimon® 0.83 EC
Insecticide (EPA Reg. No. 66222-35), an EC formulation of novaluron
containing the equivalent of 0.83 lb ai/gal.  Blueberry plants were
treated with three broadcast/directed foliar applications of Rimon® at
~0.187 lb ai/A per application, with 13- to 15- day retreatment
intervals (RTIs), for a total rate of 0.547-0.577 lb ai/A (~1x the
maximum proposed seasonal rate).  Applications were made when the crops
were at the blooming and fruiting stages using ground equipment in 40-62
gal/A spray volumes; the spray mixtures did not include the use of an
adjuvant.  Mature blueberries were harvested 6 to 8 days after the last
application (DALA).  Additional samples were harvested from one MI trial
at 1, 4, and 10 DALA to evaluate residue decline.

The harvested samples were analyzed for residues of novaluron using a
GC/ECD working method based on the method entitled “Magnitude of the
Residue of Novaluron in Pome Fruit Raw Agricultural and Processed
Commodities,” the enforcement method for plants (PP#2F6430; DP#
285474, 3/22/04, G. Kramer).  The adequacy of the method for data
collection was verified by fortifying untreated samples of blueberry
with novaluron at 0.05, 0.5, and 5.0 ppm followed by analysis of the
fortified samples.  Overall method recoveries range from 98% to 119%.

The results (see Table 5) indicate that maximum residues of novaluron
were 3.81 ppm in/on 18 samples of blueberry harvested 6 to 8 days
following the last of three treatments with Rimon® 0.83 EC Insecticide
at a total rate of 0.547-0.577 lb ai/A.  In the residue decline trial,
average residues of novaluron were observed to increase from 2.09 ppm at
the 0-day PHI to 3.11 and 3.19 ppm at the 7- and 10-day PHIs,
respectively.

Table 5.  Summary of Residue Data from Blueberry Field Trials with
Novaluron.

Crop matrix	Total Applic. Rate

 (lb ai/A)	PHI (days)	Residue Levels (ppm)

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

Bushberry, subgroup 13-07B (proposed use = 0.58 lb ai/A total
application rate, 8-day PHI)

Blueberry	0.547-0.577	6-8	18	0.607	3.81	3.36	1.83	1.97	1.05

1  HAFT = highest-average field trial result.

Conclusions:  Geographic representation of residue data is in accordance
with OPPTS Test Guideline 860.1500 for blueberry as the representative
crop of the bushberry subgroup 13-07B.  The field trial data reflect the
proposed use rate and PHI for the bushberry subgroup.

The field trial data for blueberry 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 (7.0 ppm) for residues of novaluron in/on bushberry
subgroup 13-07B.

Mustard Greens

DER References:  47526902.der.doc

Eleven trials were conducted in the U.S. and Canada encompassing NAFTA
Growing Zones 2 (MD, NC, NJ; 1 trial), 3 (FL; 1 trial), 4 (TN; 1 trial),
5 (ON; 2 trials), 6 (TX; 1 trial), 10 (CA; 2 trials), and 12 (BC; 1
trial) during the 2004 growing season.  At each trial location,
novaluron (formulated as Novaluron 0.83 EC) was applied to mustard
greens in three foliar applications of 0.077-0.085 lb ai/A/application
at 6-8 day RTIs, for a total seasonal rate of 0.233-0.251 lb ai/A.  The
CA*43, FL19, and NC07 trials had an additional treated plot that
included an adjuvant (0.25% COC) in the spray mixture for all
applications.  The first application in the TX*14, ON09, and ON10 trials
included the adjuvant, but the remaining two applications in these
trials were made without the COC.  All crops in the residue trials were
harvested 3-4 DALA, with additional PHIs of 7, 9, and 13 days for the
residue decline trial (MD07).

The harvested samples were analyzed for residues of novaluron using a
GC/ECD working method based on the method entitled “Magnitude of the
Residue of Novaluron in Pome Fruit Raw Agricultural and Processed
Commodities,” the enforcement method for plants (PP#2F6430; DP#
285474, 3/22/04, G. Kramer).  The LLMV for mustard greens was 0.05 ppm
for novaluron.  The calculated limit of detection (LOD) and LOQ for the
method was 0.01 ppm and 0.03 ppm, respectively.  The method was
adequately validated in mustard greens, with recoveries ranging from
75.6 to 84.8% in samples spiked the LLMV.  Concurrent recoveries when
spiked at the LLMV ranged from 71.0 to 77.6%. 

The data indicated that total residues of novaluron in/on mustard greens
(leaves) when treated without COC at rates of 0.233-0.251 lb ai/A/season
ranged from 1.39 to 14.56 ppm, when harvested at PHIs of 3-4 days.  For
mustard greens treated with COC and novaluron at rates of 0.239-0.242 lb
ai/A/season and harvested at 3-day PHIs, residues ranged from 2.04 to
18.54 ppm.  As the COC appeared to result in increased residues in one
of the three side-by-side trials, a general conclusion about the effects
of COC use on novaluron residues in/on mustard greens cannot be made
from these data.  The residue decline trial indicated that residues
declined with increasing PHIs in/on mustard greens.

TABLE C.5.	Summary of Residue Data from Crop Field Trials with
Novaluron.

Commodity	Total Applic. Rate

 g a.i./ha 

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

	n	Min.	Max.	HAFT1	Median2	Mean2	Std. Dev.

Mustard Greens (Leaves) without crop oil concentrate from all trials
261-275

(0.233-0.245)	3-4	16	1.39	14.56	11.05	3.98	5.33	3.98

7	2	8.53	10.05	9.29	--	--	--

9	2	7.13	7.95	7.54	--	--	--

13	2	6.85	7.00	6.93	--	--	--

Mustard Greens (Leaves) with crop oil concentrate in the first
application only3	271-281

(0.242-0.251)	3-4	6	1.90	3.24	3.03	2.49	2.47	0.50

Side-by-side trials comparing the effect of crop oil concentrate
(adjuvant)

Mustard Greens (Leaves) with crop oil concentrate, in side-by-side
adjuvant trials	268-271

(0.239-0.242)	3	6	2.04	18.54	18.32	4.75	8.53	7.66

Mustard Greens (Leaves) without crop oil concentrate, in side-by-side
adjuvant trials	265-275

(0.236-0.245)	3	6	2.09	14.56	11.05	4.55	5.98	4.68

1 HAFT = highest-average field trial.

2 Not calculated for n<3.  

3 Not side-by-side trials.  However, in the two ON trials and at the
TX14 trial site, COC (0.25%) was added to the tank mix for the first
application only.  Initially all trials were to include COC, however the
protocol was changed due to phytotoxicity observed in the TX*14 trial. 
For the two ON trials, the COC was erroneously added for the first
applications at each trial location.  

Conclusions:  Geographic representation of residue data is in accordance
with OPPTS Test Guideline 860.1500 for mustard greens as the
representative crop of the Brassica, leafy greens, subgroup 5B.  The
majority of the field trial data reflects the proposed use rate and PHI
for Brassica, leafy greens, subgroup 5B.

Since the use of crop oil concentrate on mustard greens was inconclusive
and is prohibited on the label, the data from crops which had any crop
oil concentrate applied were not included in the tolerance calculation. 
This includes the side-by-side trials at CA*43, FL19, and NC07 where COC
was used for all three applications, and the ON09, ON10, and TX14
trials, where COC was included in the first Rimon® applications.  The
remaining field trial data for mustard greens 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 (25 ppm) for residues of novaluron in/on
Brassica, leafy greens, subgroup 5B.  The available data will be
translated to turnip greens and support the proposed tolerance of 25 ppm
for turnip, greens.   

Peach

DER References:  47526903.der.doc

Sixteen supervised trials were conducted in the U.S. and Canada
encompassing NAFTA Growing Zones 1 (NY; 1 trial), 2 (NC, NJ; 2 trials),
5 (ON; 4 trials), 6 (TX; 1 trial), 10 (CA; 4 trials), and 11 (BC; 1
trial) during the 2005 growing season.  Three foliar-directed spray
applications of novaluron (formulated as Rimon® 0.83 EC) were made in
each trial, except in the Texas trial (TX31) where the slow growth of
the peaches resulted in the addition of two more applications for a
total of five applications.  The application rates ranged from
0.322-0.348 lb ai/A/application with 10-14 day RTIs, for a total
seasonal rate ranging from 0.98-1.04 lb ai/A for the trials with three
applications.  In the Texas trial, the five applications resulted in a
total seasonal rate of 1.66 lb ai/A.  Applications were made in spray
volumes ranging 55-116 gallons per acre (GPA).  All crops in the residue
trials were harvested at 6-7 days DALA.  Additionally, at the CA166
trial, samples were collected at 1, 4, and 10 DALA for the residue
decline trial.  No adjuvants were included in any of the spray mixes. 

Peach samples were analyzed using the working method titled “Residue
Analysis of Novaluron on Peach by GC/EC Detection, Version #1.”  This
method is similar to the enforcement method for plants entitled
“Magnitude of the Residue of Novaluron in Pome Fruit Raw Agricultural
and Processed Commodities” (PP#2F6430; DP# 285474, 3/22/04, G.
Kramer).  The LLMV for peach was 0.05 ppm for novaluron. The LOD and LOQ
for the method were calculated to be 0.019 ppm and 0.058 ppm,
respectively.  Method suitability was evaluated both prior to sample
analysis and concurrently with sample analysis.  The method was
adequately validated in peaches, with recoveries ranging from 92% to
120% when spiked with novaluron at the LLMV.  Concurrent recoveries when
spiked with novaluron at the LLMV ranged from 92% to 140%.

The data indicated that total residues of novaluron in/on peaches when
treated at rates of 0.98-1.04 lb ai/A/season and at spray volumes
ranging from 55 to 116 GPA ranged from 0.18 to 2.10 ppm, when harvested
at PHIs of 6 to 7 days.  In peaches treated at a total rate of 1.66 lb
ai/A/season and harvested at a PHI of 6 days, residues in/on the two
samples analyzed were 2.40 ppm.  The residue decline trial indicated
that residues declined from a PHI of 1 to 4 days (mean residues were
0.75 ppm to 0.57 ppm, respectively), but increased from 4 to 8 days
(mean residues were 0.57 ppm and 0.80 ppm, respectively).

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

Crop matrix	Total Applic. Rate (lb ai/A)	PHI (days)	Residue Levels (ppm)

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

(proposed use = 0.32 lb ai/A total application rate, 8-day PHI)

Peach	0.98 -1.04	6-7	30	0.18	2.10	1.55	0.50	0.61	0.38

	1.663	6	2	2.40	2.40	2.40	--2	--2	--2

1 HAFT = highest-average field trial.

2 Not calculated if n <3.  

3 Due to the slow growth of the peaches, 5 applications were used at the
TX31 field trial.

Plum

DER References:  47526904.der.doc

Eleven supervised residue trials were conducted in the U.S. and Canada
encompassing NAFTA Growing Zones 1A (NS; 1 trial), 5 (ON; 3 trials), 10
(CA; 5 trials), 11 (BC; 1 trial), and 12 (OR; 1 trial) during the 2006
growing season.  At ten trial locations, novaluron (formulated as
Rimon® 0.83 EC) was applied to plums as 3 foliar-directed applications
of 0.331-0.342 lb ai/A/application at 10-14 day RTIs, for a total
seasonal rate of 1.0-1.02 lb ai/A.  A fourth application, for a total
seasonal rate of 1.35 lb ai/A, was made to the CA 18 trial because the
plums were not mature enough for harvest after three applications.  All
plum samples in the residue trials were harvested at PHIs of 6 to 8
days, with additional PHIs of 1, 4, and 10 days for the residue decline
trial (ON10).  Applications were made in spray volumes ranging from
58-106 GPA.  No adjuvants were included in any of the spray mixes.

The plum samples were analyzed using Pyxant Labs Inc. analytical method
number STM1585.01, “Analytical Method for the Determination of
Novaluron in Crop Matrices by LC/MS/MS,” a method very similar to the
enforcement method, Pyxant Labs Inc. analytical method number
METH1585-00.00, entitled “Magnitude of the Residue of Novaluron in
Crop Matrices by LC/MS/MS” which was used to analyze residues of
novaluron in cherries.  Neither method has been previously reviewed;
however, the methods are similar to the GC/ECD method previously
proposed for enforcement purposes.  The LLMV for plum was 0.05 ppm for
novaluron.  The LOD for the method on fresh plums was calculated to be
0.01 ppm and the LOQ was calculated to be 0.03 ppm.  Method suitability
was evaluated both prior to sample analysis and concurrently with sample
analysis.  The method validation recoveries were in the range of 96-102%
for fresh plums spiked with novaluron at the LLMV.  Concurrent
recoveries obtained during sample analysis in samples spiked with
novaluron at the LLMV were in the range of 83-109% for fresh plums.

The data indicated that total residues of novaluron in/on fresh plums
ranged from 0.078-0.803 ppm when plums were treated at total seasonal
application rates of 1.0-1.02 lb ai/A/season for the ten trials which
received three applications, and at a total seasonal rate of 1.35 lb
ai/A for the trial which received four applications, and harvested at 6
to 8 day PHIs.  Applications were made in spray volumes ranging from 58
to 106 GPA.  The residue decline trial indicated that residues declined
slightly with increasing PHIs in fresh plums.

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

Crop matrix	Total Applic. Rate (lb ai/A)	PHI (days)	Residue Levels (ppm)

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

(proposed use = 0.32 lb ai/A total application rate, 8-day PHI)

Fresh Plums	1.00-1.02	1	2	0.578	0.734	0.656	--	--	--

4	2	0.715	0.764	0.740	--	--	--

6-8	20	0.078	0.803	0.769	0.378	0.403	0.234

10	2	0.480	0.516	0.498	--	--	--

	1511 (1.35)3	7	2	0.102	0.114	0.108	--	--	--

1 HAFT = highest-average field trial.

2 Not calculated if n <3.

3 A fourth application was made to the CA18 trial because the plums were
not mature enough for harvest after three applications.  

Cherry

DER References:  47526905.der.doc

Seven supervised residue trials were conducted in the U.S. and Canada
encompassing NAFTA Growing Zones 1 (NY; 1 trial, tart), 5 (MI; 2 trials,
1 sweet, 1 tart; ON; 1 trial, tart), 10 (CA; 1 trial, sweet), and 11
(OR; 1 trial, sweet; WA; 1 trial, tart) during the 2006 growing season. 
At each trial location, three applications of Novaluron 10EC (an EC)
were made at rates of 0.332-0.349 lb ai/A/application at 10-14 day RTIs,
for a total seasonal rate of 1.00-1.02 lb ai/A.  Applications were made
in spray volumes ranging from 77.3 to 97.7 GPA.  All crops in the
residue trials were harvested 7 DALA, with additional PHIs of 0, 3, 10,
and 14 days for the residue decline trial (MI1).  No adjuvants were
included in any of the spray mixes.

Cherry samples were analyzed using a method based on Pyxant Labs Inc.
analytical method number METH1585-00.00, entitled “Magnitude of the
Residue of Novaluron in Crop Matrices by LC/MS/MS.”  The method has
not been previously reviewed, however it is similar to the GC/ECD method
previously proposed for enforcement purposes.  Based on the LLMV, the
LOQ was 0.05 ppm and the LOD was set at 0.015 ppm (30% of the LOQ). 
Method suitability was evaluated both prior to sample analysis and
concurrently with sample analysis.  The method validation recoveries
were in the range of 109-116% for cherries spiked with novaluron at the
LOQ.  Concurrent recoveries obtained during sample analysis in samples
spiked with novaluron at the LOQ were in the range of 91-98% for
cherries.

The data indicated that total residues of novaluron in/on cherries when
treated at total rates of 1.00-1.02 lb ai/A/season and spray volumes
ranging from 77.3 to 97.7 GPA ranged from 1.97 ppm to 2.68 ppm, when
harvested at a PHI of 7 days.  The residue decline trial indicated that
residues were similar at PHIs ranging from 0 to 14 days. 

Table 9.  Summary of Residue Data from Cherry Field Trials with
Novaluron.

Crop matrix	Total Applic. Rate (lb ai/A)	PHI (days)	Residue Levels (ppm)

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

(proposed use = 0.32 lb ai/A total application rate, 8-day PHI)

Cherry	1.00	0	2	2.27	2.50	2.39	--2	--	--

	1.00	3	2	1.97	2.68	2.33	--	--	--

	1.00-1.02	7	14	0.739	4.08	3.71	2.04	2.17	1.18

	1.00	10	2	2.03	2.28	2.16	--	--	--

	1.00	14	2	2.43	2.97	2.70	--	--	--

1 HAFT = highest-average field trial.

2 Not calculated if n <3.  

Conclusions:  Geographic representation of residue data is in accordance
with OPPTS Test Guideline 860.1500 for peaches, plums, and cherries as
representative commodities of the fruit, stone, group 12 crop group. 
With the exception of the TX31 peach field trial and the CA18 plum field
trial, the field trial data reflect the proposed use rate and PHI for
stone fruit.  Because the TX31 peach field trial and the CA18 plum field
trial data did not reflect the label use directions, they were excluded
from tolerance calculations.  The TX31 trial was excluded because the
trial did not follow the label in regards to spray volume, number of
applications, and type of application equipment (i.e., use of a
compressed-air backpack mist blower as opposed to a conventional ground
sprayer).  An additional peach field trial is not being requested
because representation of all other regions is adequate.  The CA18 plum
field trial was also excluded from the calculations for determining the
appropriate tolerances.  This trial was conducted at an exaggerated rate
and was stored for a longer time period (~16 months) than storage
stability data for novaluron is available (12 months).  Additional field
trials are not being requested because the geographic representation is
adequate for both the peach and plum trials.

The field trial data for peaches, plums, and cherries 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
supports tolerances of 1.9 ppm for residues of novaluron in/on fruit,
stone, group 12, except cherry and 8.0 ppm in/on cherry.  

860.1520 Processed Food and Feed

HED does not require residue data for any processed commodities
associated with bushberry subgroup 13-07B or Brassica, leafy greens,
subgroup 5B.  Therefore, data requirements for processed food and feed
are not relevant to these commodities.  There are, however, processed
commodities associated with fruit, stone, group 12 and a processing
study on plums was submitted.

Dried Plums

DER References:  47526904.der.doc

To determine the potential for residues of novaluron to concentrate
in/on dried plums, novaluron (formulated as Rimon® 0.83 EC) was applied
to plums as 3 foliar applications of 0.335-0.341 lb ai/A, with 10-14 day
RTIs.  The total application rate corresponded to 1.01-1.02 lb
ai/A/season and applications were made in spray volumes ranging from 58
to 106 GPA.  Mature plums were harvested 8 DALA.  No adjuvants were
added to any of the spray mixes.  In trial CA14, fresh plum samples were
placed in a forced-air dryer on Teflon-coated pizza trays.  Dried plum
samples were collected after the weight of the plums had declined by a
factor of ~2.8 (fresh weight/2.8).  In trial CA17, fresh plum samples
were placed on metal drying trays lined with newspaper and held in
dryers for two days at ~60oC.

The plum samples were analyzed using Pyxant Labs Inc. analytical method
number STM1585.01, “Analytical Method for the Determination of
Novaluron in Crop Matrices by LC/MS/MS,” a method similar to the
enforcement method, Pyxant Labs Inc. analytical method number
METH1585-00.00, entitled “Magnitude of the Residue of Novaluron in
Crop Matrices by LC/MS/MS” which was used to analyze residues of
novaluron in cherries.  Neither method has been previously reviewed,
however the methods are similar to the GC/ECD method previously proposed
for enforcement purposes.  The LLMV for plum (fresh and dry) was 0.05
ppm for novaluron.  The LOD for the method on fresh plums was calculated
to be 0.01 ppm and the LOQ was calculated to be 0.03 ppm.  The LOD for
the method for dry plums was calculated to be 0.02 ppm and the LOQ was
calculated to be 0.05 ppm.  Method suitability was evaluated both prior
to sample analysis and concurrently with sample analysis.  The method
validation recoveries were in the ranges 96-102% for fresh plums spiked
with novaluron at the LLMV.  Concurrent recoveries obtained during
sample analysis in/on samples spiked with novaluron at the LLMV were in
the range 83-109% for fresh plums.  For dry plums spiked at the LLMV,
method validation recoveries ranged from 91-94% and concurrent
recoveries ranged from 93-108%.

Residues of novaluron in/on treated fresh plums were 0.410 ppm and 0.320
ppm in the CA14 and CA17 trial, respectively.  No detectable residues
were found in/on treated dry plums from the CA17 trial.  It was reported
that possible mislabeling of sample bags may have occurred in the CA17
trial.  Therefore given the uncertainty regarding samples taken from
trial CA17, results from this trial are deemed invalid.  Residues of
novaluron in/on treated dry plums were 1.39 ppm in the CA14 trial,
indicating a concentration factor of 3.39x for this processed commodity.
 The maximum theoretical concentration factor for the processing of
fresh plums to dry plums is 5.0x.

Conclusions:  For dried plums, the processed food data are classified as
scientifically acceptable pending submission of freezer storage
stability data for dried plums.  The available data support a tolerance
of 2.6 ppm for residues of novaluron in/on dried plums.

  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

Bushberries and stone fruit are typically not rotated; however, Brassica
leafy greens and turnip greens 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.  Based on the results of the confined rotational crop study,
the appropriate PBI for all non-labeled crops is 30 days.  The current
and proposed labels include a restriction that only registered crops may
be rotated to a treated field within 30 days of the final application.  

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

860.1550 Proposed Tolerances

HED has determined that the residue of concern in plants for tolerance
enforcement is novaluron only.  The proposed tolerance expression 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:”

The available field trial data for blueberry, mustard greens, peaches,
fresh plums, and cherries 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 tolerance spreadsheet recommends
a tolerance of 7.0 ppm for blueberry, the representative crop of the
bushberry subgroup 13-07B and 25 ppm for mustard greens, the
representative crop for Brassica, leafy greens, subgroup 5B.  For
peaches, fresh plums, and cherries, the representative crops of the
fruit, stone, group 12 crop group, the tolerance spreadsheet recommends
tolerances of 1.8 ppm, 1.9 ppm, and 8.0 ppm, respectively.  Therefore,
the recommended tolerances are 1.9 ppm is for fruit, stone, group 12,
except cherry and 8.0 ppm for cherry.  The tolerance for dried plums
(prunes) was calculated to be 2.6 ppm.    

No Codex, Canadian, or Mexican MRLs have been established for novaluron
on bushberries, Brassica, leafy greens, turnip greens, and stone fruit. 
Canada is currently in the process of reviewing the use of novaluron on
Brassica, leafy greens, subgroup 5B and fruit, stone, group 12.  EPA and
PMRA tolerance recommendations have been harmonized at 7.0 ppm for
Brassica, leafy greens, subgroup 5B, 1.9 ppm for fruit, stone, group 12,
except cherry, 8.0 ppm for cherry, and 2.6 ppm for dried plums (personal
communication with Monica Le of PMRA, 28-AUG-2009).  

A summary of HED’s recommended tolerances for the current petition is
presented in Table 10.  The proposed tolerance should be revised to
reflect the correct commodity definition as specified in Table 10.

Table 10.  Tolerance Summary for Novaluron.

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

Correct Commodity Definition

Bushberry subgroup 13-07B	7.0	7.0

	Brassica, leafy greens, subgroup 5B	25	25	Brassica, leafy greens,
subgroup 5B

Turnip, greens	25	25

	Fruit, stone, group 12	8.0	1.9	Fruit, stone, group 12, except cherry

Cherry	-	8.0	Cherry

Plum, prune, dried	-	2.6	Plum, prune, dried

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 (9/9/09), RAB1 Chemists (6/3/09)

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:  04/28/09

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:  8E7425; 8E7426

DP#:  D357060; D357078

 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, 04/29/2009.

Appendix I.  Tolerance-Assessment Calculations.

Blueberries

The dataset used to establish a tolerance for novaluron on bushberry
subgroup 13-07B consisted of field trial data for the representative
crop, blueberry, representing application rates of 0.547-0.577 lb ai/A
(3 applications at 0.180-0.198 lb ai/A per application) with a 6- to
8-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.1.

All 18 field trial sample results were above the LOQ (LLMV = 0.05 ppm). 
Visual inspection of the lognormal probability plot (Figure I.1) and the
results from the approximate Shapiro-Francia test statistic (Figure I.2)
indicated that the dataset was reasonably lognormal.

Since the field trial data for novaluron on blueberry 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 8.0 ppm and the
point estimate of the 99th percentile rounds to the value 7.0 ppm
(Figure I.2).  Because the 7.0-ppm value was the minimum value, 7.0 ppm
is the recommended tolerance level for novaluron in/on blueberry
(bushberry subgroup 13-07B).  

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

Regulator:	EPA

Chemical:	Novaluron

Crop:	Blueberry

PHI:	6 to 8 Days

App. Rate:	0.547-0.577 lb ai/A

Submitter:	IR-4

MRID Citation:	47526901

	Residues of Novaluron (ppm)

	2.900

	3.810

	1.410

	2.030

	0.693

	0.993

	0.625

	1.090

	0.607

	1.040

	3.040

	3.170

	3.000

	3.490

	1.620

	2.130

	1.610

	2.280

Figure I.  SEQ Figure_II- \* ARABIC  1 .  Lognormal Probability Plot of
Novaluron Field Trial Data for Blueberries.

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

Mustard Greens

The dataset used to establish a tolerance for novaluron on Brassica,
leafy greens, subgroup 5B consisted of field trial data for the
representative crop, mustard greens, representing application rates of
0.233-0.251 lb ai/A (3 applications at 0.077-0.085 lb ai/A per
application) with a 3- to 4-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.2.

All 22 field trial sample results were above the LOQ (0.03 ppm).  Visual
inspection of the lognormal probability plot (Figure I.3) and the
results from the approximate Shapiro-Francia test statistic (Figure I.4)
indicated that the dataset was reasonably lognormal.

Since the field trial data for novaluron on mustard greens represent a
large dataset (i.e., more than 15 samples) and are reasonably lognormal,
the point estimate of the 99th percentile should be selected as the
tolerance value.  Using the rounding procedure as outlined in the SOP,
the point estimate of the 99th percentile rounds to the value 25 ppm
(Figure I.4).  Therefore, 25 ppm is the recommended tolerance level for
novaluron in/on mustard greens (Brassica, leafy greens, subgroup 5B).   



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

Regulator:	EPA

Chemical:	Novaluron

Crop:	Mustard Greens

PHI:	3 to 4 Days

App. Rate:	0.233-0.251 lb ai/A

Submitter:	IR-4

MRID Citation:	47526902

	Residues

	4.46

	5.22

	3.22

	4.38

	5.77

	3.3

	14.56

	7.53

	14.2

	7.83

	2.63

	2.09

	2.11

	1.39

	3.58

	3



Figure I.3.  Lognormal Probability Plot of Novaluron Field Trial Data
for Mustard Greens.

 

Figure I.4.  Tolerance Spreadsheet Summary of Novaluron Field Trial Data
for Mustard Greens.

 

Peaches

The dataset used to establish a tolerance for novaluron on fruit, stone,
group 12 consisted of field trial data for the representative crops:
peaches, plums, and cherries.  For peaches, the field trial data
represented application rates of 0.98-1.04 lb ai/A (3 applications at
0.322-0.348 lb ai/A/application) with a 6- to 7-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.3.

All 30 field trial sample results were above the LOQ (0.058 ppm). 
Visual inspection of the lognormal probability plot (Figure I.5) and the
results from the approximate Shapiro-Francia test statistic (Figure I.6)
indicated that the dataset was reasonably lognormal.

Since the field trial data for novaluron on peaches 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 1.8 ppm and the
point estimate of the 99th percentile rounds to the value 2.0 ppm
(Figure I.6).  Because the 1.8-ppm value was the minimum value, 1.8 ppm
is the recommended tolerance level for novaluron in/on peaches.  

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

Regulator:	EPA

Chemical:	Novaluron

Crop:	Peaches without TX31 Trial

PHI:	6 to 7 Days

App. Rate:	0.98-1.04 lb a.i./A

Submitter:	IR-4

MRID Citation:	47526903

	Residues

	0.440

	0.660

	0.410

	0.380

	0.250

	0.200

	0.800

	0.510

	0.900

	0.720

	2.100

	1.000

	0.420

	0.340

	1.000

	0.980

	1.000

	0.770

	0.200

	0.180

	0.490

	0.580

	0.470

	0.490

	0.520

	0.580

	0.420

	0.270

	0.700

	0.380

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

 

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

 

Plums

The dataset used to establish a tolerance for novaluron on fruit, stone,
group 12 consisted of field trial data for the representative crops:
peaches, plums, and cherries.  For plums, the field trial data
represented application rates of 1.00-1.02 lb ai/A (3 applications at
0.321-0.342 lb ai/A/application) with a 6- to 8-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.4.

All 20 field trial sample results were above the LOQ (0.03 ppm).  Visual
inspection of the lognormal probability plot (Figure I.7) and the
results from the approximate Shapiro-Francia test statistic (Figure I.8)
indicated that the dataset was reasonably lognormal.

Since the field trial data for novaluron on plums 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 2.0 ppm and the
point estimate of the 99th percentile rounds to the value 1.9 ppm
(Figure I.8).  Because the 1.9-ppm value was the minimum value, 1.9 ppm
is the recommended tolerance level for novaluron in/on plums.  



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

Regulator:	EPA

Chemical:	Novaluron

Crop:	Plums without CA18 Trial

PHI:	6 to 8 Days

App. Rate:	1.00-1.02 lb a.i./A

Submitter:	IR-4

MRID Citation:	47526904

	Residues

	0.465

	0.420

	0.192

	0.260

	0.082

	0.078

	0.348

	0.315

	0.094

	0.161

	0.803

	0.735

	0.788

	0.628

	0.615

	0.624

	0.482

	0.408

	0.327

	0.241

Figure I.7.  Lognormal Probability Plot of Novaluron Field Trial Data
for Fresh Plums.

 

Figure I.8.  Tolerance Spreadsheet Summary of Novaluron Field Trial Data
for Fresh Plums.

 

Cherries

ഀࣆȀỰ⒐싁摧噧Ð

H

 

,

-

2

U

R

š

›

Ì

ß

à

m

n

o

‚

 U

Y

Z

d

e

k

l

s

›

¢

£

½

Ä

Ó

Ö

à

ã

å

l

m

o

€

 h3

%€

‚

hM

 hÛ

h

h

h

h…

gdI~

 hI~

h…

 hI~

hI~

m

 h

h

h

 hh

 hh

kd

hI~

愀Ĥ摧略¡

愀Ĥ摧⌭

愀Ĥ摧啮ë

hI~

摧淓z

ഀ׆Ā褐㄀Ĥ摧繉

hI~

/

㓿ۖĀ̊&☃昀Ĵ瑹၈ñ

愀Ĥ摧၈ñ

愀Ĥ摧၈ñ

愀Ĥ摧၈ñ

愀Ĥ摧၈ñ

h†K

愀Ĥ摧ẏÀ

愀Ĥ摧ẏÀ

愀Ĥ摧ẏÀ

愀Ĥ摧ẏÀ

h

hÏ

혈\ᴄ琀㘑괙耤圆

眆

혈\ᴄ琀㘑괙耤圆

w

w

w

w

:

B

Ù

ß

ç

í

ö

û



Ò

Ú

Ù

ç

õ

ö

	

 h$ 

 h$ 

 h$ 

 h$ 

 h$ 

kd

kd

 hòI

 hòI

kd

 h|

  h|

h|

 h|

h|

h|

h|

  h|

h|

h|

 h|

h|

 h|

  h|

kd2

kdî

kdf

a$gd|

a$gd|

a$gd|

a$gd|

a$gd|

a$gd|

a$gd|

a$gd|

a$gd|

a$gd|

a$gd|

a$gd|

a$gd|

a$gd|

a$gd|

a$gd|

a$gd|

a$gd|

a$gd|

h|

  h|

ᔚ籨

h|

h|

h|

h|

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.

All 14 field trial sample results were above the LOQ (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 cherries represent a small
dataset (i.e., less 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 10 ppm and the
point estimate of the 99th percentile rounds to the value 8.0 ppm
(Figure I.10).  Because the 8.0-ppm value was the minimum value, 8.0 ppm
is the recommended tolerance level for novaluron in/on cherries.  

Table I.5.  Residue Data Used to Calculate Tolerance for Novaluron on
Sweet and Tart Cherries.

Regulator:	EPA

Chemical:	Novaluron

Crop:	Sweet and Tart Cherries

PHI:	7 Days

App. Rate:	1.00-1.02 lb ai/A

Submitter:	IR-4

MRID Citation:	47526905

	Residues of Novaluron (ppm)

	2.240

	1.950

	1.980

	1.410

	4.080

	3.340

	3.540

	3.880

	0.802

	0.966

	2.660

	2.090

	0.759

	0.739

Figure I.9.  Lognormal Probability Plot of Novaluron Field Trial Data
for Sweet and Tart Cherries.

 

Figure I.10.  Tolerance Spreadsheet Summary of Novaluron Field Trial
Data for Sweet and Tart Cherries.

 

Novaluron	Summary of Analytical Chemistry and Residue Data	DP#:  D357060

 PAGE   

Page   PAGE  5  of   NUMPAGES  36