Document ID: EPA-HQ-OPP-2009-0273-0011
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2010-05-26T04:00Z

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, D.C.  20460

	OFFICE OF PREVENTION, PESTICIDES,

	AND TOXIC SUBSTANCES

  SEQ CHAPTER \h \r 1 MEMORANDUM

Date:		23-FEB-2010

SUBJECT:	Novaluron.  Petition for the Establishment of Permanent
Tolerances for Residues of Novaluron in/on Grain Sorghum.  Summary of
Analytical Chemistry and Residue Data.

PC Code:  124002	DP Barcode:  D374420

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

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

Risk Assessment Type:  NA	Case No.:  NA

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

MRID No.:  47727201	40 CFR:  §180.598

  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:		John Hebert (RM 07)/ Jennifer Gaines  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, sugarcane, bushberry subgroup 13-07B, Brassica, leafy greens
(subgroup 5B), turnip greens, and stone fruit (crop group 12). 
Registrations are pending for fruiting vegetables group 8, cucurbit
vegetable group 9, low growing berry subgroup 13-07G (except lowbush
blueberry), miscellaneous fruiting vegetables, snap bean, dry bean seed,
and Swiss chard.  The basic producer of novaluron is Makhteshim-Agan of
North America (MANA).  End-use products containing novaluron as the
active ingredient (ai) are formulated as an emulsifiable concentrate
(EC), a suspension concentrate (SC), or a water-dispersible granular
(WDG).

Under petition 9F7547, MANA requests the establishment of a permanent
tolerances for residues of the insecticide novaluron,
N-[[[3-chloro-4-[1,1,2-trifluoro-2-(trifluoromethoxy)ethoxy]phenyl]amino
]carbonyl]-2,6-difluorobenzamide, in/on:

Grain sorghum, grain	3 ppm

Grain sorghum, aspirated grain fractions	25 ppm

Grain sorghum, forage	6 ppm

Grain sorghum, stover	40 ppm

To support the submission for permanent tolerances for residues of
novaluron in/on grain sorghum grain, forage, stover, and aspirated grain
fractions (AGF), MANA proposes tolerance increases for residues of the
insecticide novaluron,
N-[[[3-chloro-4-[1,1,2-trifluoro-2-(trifluoromethoxy)ethoxy]phenyl]amino
]carbonyl]-2,6-difluorobenzamide, in/on livestock commodities as
follows:

Hog muscle	0.07 ppm

Hog liver	0.15 ppm

Hog kidney	0.15 ppm

Hog fat	1.5 ppm 

Poultry muscle	0.4 ppm

Poultry liver	0.8 ppm

Poultry kidney	0.8 ppm

Poultry fat	7.0 ppm

Eggs	1.5 ppm

The end-use product associated with these registration requests is
Rimon® 0.83EC Insecticide (EPA Reg. No. 66222-35), an EC formulation
containing 9.3% ai (equivalent to 0.83 lb ai/gal).  The sorghum label
proposes a maximum seasonal Rimon® application rate of 0.23 lb ai/A
(0.058 to 0.078 lb ai/A/application) with 7- to 14-day retreatment
intervals (RTIs) and a 14-day preharvest interval (PHI).  The field
trial data supports PHIs of 7 days for forage and 14 days for grain and
stover, as well as the application rates for grain sorghum specified in
the label.  A revised Section B is requested which specifies that the
use of adjuvants/surfactants on grain sorghum is prohibited and includes
a statement which prohibits the use of novaluron on crops grown for food
in greenhouses, except tomatoes.  The revised Section B for petition
9F7547 should also specify that the label is for “grain sorghum” as
opposed to “sorghum” and specify separate PHIs for grain sorghum
forage (7 days), grain (14 days), and stover (14 days).  

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

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

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

There are adequate residue analytical methods for the enforcement of
residue tolerances.  For analysis of crop matrices for residues of
novaluron, gas chromatography/electron-capture detection (GC/ECD) and
high-performance liquid chromatography/ultraviolet (HPLC/UV) methods are
available.  These methods have undergone successful validation by the
Analytical Chemistry Branch of the Biological and Economics Analysis
Division (ACB/BEAD) and have been forwarded to Food and Drug
Administration (FDA) for inclusion in the Pesticide Analytical Method
Volume II (PAM II; Memo, S. Levy, 15-SEP-2004; D307595).   

Samples of grain sorghum forage, grain, stover, aspirated grain
fractions (AGF), and flour from the field trials and processing studies
were analyzed for residues of novaluron using a liquid chromatography
method with tandem mass-spectrometric detection (LC/MS/MS) method that
is similar to the GC/ECD enforcement method.  Acceptable method
validation and concurrent method recovery data were submitted with the
petition.  

The requirements for Multiresidue Methods (MRMs) testing data for
novaluron are fulfilled.  The available data indicate that novaluron
could not be recovered through application of the multiresidue protocols
(Memo, S. Levy, 19-OCT-2005; D322359).  

Concurrent storage stability data for grain sorghum forage, grain, AGF,
flour, and stover were not generated.  No suitable freezer storage
stability data have been submitted to support the grain sorghum forage,
grain, AGF, flour, and stover frozen storage intervals for the submitted
study.  Therefore, the data for grain sorghum are classified as
scientifically acceptable pending submission of freezer storage
stability data for residues of novaluron in/on grain sorghum forage,
grain, AGF, and stover.  

The submitted field trial residue data for grain sorghum forage, grain,
and stover are adequate to support the establishment of the requested
tolerances, pending the submission of storage stability data.  

An acceptable processing study was submitted.  The maximum residues of
novaluron were 1.20 ppm in/on the sorghum grain raw agricultural
commodity (RAC), 16.0 ppm in/on the sorghum AGF, and 0.795 ppm in/on the
sorghum flour, indicating processing factors of 13X for the sorghum AGF
and 0.66X for sorghum flour.  

The field trial data were entered into the Agency’s maximum residue
limits (MRL) tolerance spreadsheet to determine appropriate tolerances. 
The output from the tolerance spreadsheet supports the MANA proposed
tolerances of 3.0 ppm for grain sorghum, grain; 25 ppm for AGF; 6.0 ppm
for grain sorghum, forage; and 40 ppm for grain sorghum, stover.  New
reasonably balanced dietary burdens (RBDBs) were constructed based on
the proposed new use on sorghum and support MANA’s proposed increases
in the tolerances for poultry, fat to 7.0 ppm; poultry, meat to 0.40
ppm; poultry, liver to 0.80 ppm; poultry, kidney to 0.80 ppm; egg to 1.5
ppm; hog, meat to 0.07 ppm; and hog, fat to 1.5 ppm.  The appropriate
tolerance for both hog liver and hog kidney is 0.10 ppm.  Tolerances of
0.80 ppm and 0.10 ppm are also required for poultry, meat byproducts and
hog, meat byproducts, respectively.   

No Codex, Canadian, or Mexican MRLs have been established for novaluron
in/on grain sorghum forage, stover, grain, and AGF.  

  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, Storage Stability Data, and Proposed Tolerances),
there are no residue chemistry issues that would preclude granting a
conditional registration for the use of novaluron on grain sorghum.  

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

Grain, aspirated fractions	25 ppm

	Poultry, fat	7.0 ppm

Sorghum, grain, grain	3.0 ppm

	Egg		1.5 ppm

Sorghum, grain, forage	6.0 ppm

	Hog, meat	0.07 ppm

Sorghum, grain, stover	40 ppm

	Hog, liver	0.10 ppm

Poultry, meat	0.40 ppm

	Hog, kidney	0.10 ppm

Poultry, liver	0.80 ppm

	Hog, meat byproducts	0.10 ppm

Poultry, kidney	0.80 ppm

	Hog, fat		1.5 ppm

Poultry, meat byproducts	0.80 ppm

A human-health risk assessment is forthcoming in a separate document
(D364307).  The residue chemistry database will support unconditional
registration upon submission of data/information which adequately
addresses the following issues:  

860.1200 Directions for Use

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

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

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

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

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

860.1380 Storage Stability Data

Storage stability data on grain sorghum forage, grain, AGF, and stover
for up to 275, 253, 237, and 245 days, respectively, are required.  

860.1550 Proposed Tolerances

A revised Section F for petition number 9F7547 should be submitted which
cites the appropriate CAS name for novaluron:

“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 12.  

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

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

MANA submitted a draft label for Rimon® 0.83EC Insecticide (EPA Reg.
No. 66222-35) to include the proposed new use (see Table 3) on grain
sorghum.

Table 3.  Summary of Directions for Use of Novaluron.

Application Equipment	Formulation

[EPA Reg. No.]	Applic. Rate 

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

(lb ai/A)	PHI

(days)	Use Directions and Limitations

Grain Sorghum

Aerial/ Groundboom	0.83 lb/gal EC

[66222-35]	0.058-0.078	3	0.23	14	A 7 to 14 day RTI is specified to
protect new growth.  For the most effective control, fields should be
scouted twice weekly.  

For ground applications to vegetables, a minimum spray volume of 10
gallons per acre (GPA) should be used.  Aerial applications are to be
made in 2-10 GPA.  Applications of Rimon® 0.83EC may also be made
through sprinkler irrigation systems; use of other types of irrigation
systems is prohibited.  The accepted (master) label for Rimon® 0.83EC
Insecticide states that only registered crops may be rotated in a
treated field within 30 days of application.  The current and proposed
labels include a restriction that only registered crops may be rotated
to a treated field within 30 days of the final application.  A revised
Section B is requested which specifies that the use of
adjuvants/surfactants on grain sorghum is prohibited and includes a
statement which prohibits the use of novaluron on crops grown for food
in greenhouses, except tomatoes.  The revised Section B for petition
9F7547 should also specify that the label is for “grain sorghum” as
opposed to “sorghum” and specify separate PHIs for grain sorghum
forage (7 days), grain (14 days), and stover (14 days).  

 

Conclusions:  The proposed label is adequate to allow evaluation of the
residue data relative to the proposed new use on grain sorghum; however,
a revised Section B is requested which:  

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

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

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

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

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 (Memo, G. Kramer,
22-MAR-2004; D285474).  These studies indicate that novaluron is not
extensively metabolized in these crops.  The parent compound, novaluron,
was either the only residue component identified or was the predominant
residue component in all analyzed plant matrices.  The reviewed studies
also indicate novaluron, when foliarly applied during the vegetative
growth stage, is not readily translocated to mature apple fruit, potato
tubers, or cottonseed (Memo, G. Kramer, 22-MAR-2004; D285474).  The HED
MARC determined that the residue of concern in crops for purposes of
tolerance enforcement and risk assessment is novaluron only (Memo, G.
Kramer et al., 03-FEB-2004; D297646).  

860.1300 Nature of the Residue - Livestock

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

860.1340 Residue Analytical Methods

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

Residue Chemistry Memo, DP# 306998, 9/15/04, S. Levy (PMV Results)

Residue Chemistry Memo, DP# 307595, 9/15/04, S. Levy (PP#2F6430; Memo to
FDA)

Residue Chemistry Memo, DP#s 322978 & 315780, 11/3/05, S. Levy
(PP#4E6834)

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

Enforcement Methods:    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).

Grain Sorghum Data-Collection:   Samples of grain sorghum forage, grain,
stover, AGF, and flour were analyzed for residues of novaluron using a
method similar to the GC/ECD enforcement method.  Briefly, homogenized
samples of grain sorghum forage, grain, stover, AGF, and flour were
extracted twice with ACN and the extracts were isolated by
centrifugation, combined, and diluted with ACN.  Residues of novaluron
were quantitated using LC/MS/MS.  

Prior to the analysis of field samples, the method was validated using
samples of untreated grain sorghum forage, grain, and stover fortified
with novaluron at 0.05-2.5 ppm.  The method was also validated
concurrently with the analysis of field samples, using samples of
untreated forage, grain, and stover fortified with novaluron at
0.05-5.0, 00.05-2.5, and 0.05-20 ppm, respectively.  The validated LOQ
for novaluron was 0.05 ppm in each sorghum matrix.  

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

860.1360 Multiresidue Methods

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

  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)

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

Storage stability data for novaluron were presented in PP#2F6430.  These
data show that fortified residues of novaluron are reasonably stable
under frozen conditions in/on pears for up to 5.2 months; broccoli,
cabbage, and tomato for up to 6 months; apple and potato for up to 12
months; and apple juice for up to 3.3 months.  Concurrent storage
stability data was submitted for blueberries, mustard greens, and
peaches in PP#8E7425, which demonstrated that fortified residues of
novaluron are relatively stable under frozen conditions in/on blueberry,
mustard greens, and peaches for up to 4.9 months, 15.3 months, and 3.8
months, respectively.  Storage stability data have also been submitted
which demonstrate that fortified residues of novaluron are relatively
stable under frozen conditions in/on bell pepper for 6.7 months,
cantaloupe for 7.0 months, summer squash for 9.4 months, strawberry for
11.7 months, snap bean pods with seeds for 8.6 months, snap bean foliage
for 8.7 months, dry bean seed for 5.0 months, and Swiss chard for 11.7
months.  

Concurrent storage stability data for sorghum forage, grain, AGF, flour,
and stover were not generated.  No suitable freezer storage stability
data have been submitted to support the sorghum forage, grain, AGF,
flour, and stover frozen storage intervals for the submitted study. 
Therefore, the data for grain sorghum are classified as scientifically
acceptable pending submission of freezer storage stability data for
residues of novaluron in/on grain sorghum forage, grain, AGF, and
stover.  

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

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

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

 (6.1-9.0 months)	None.

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

(5.4-8.3 months)	None.

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

 (5.5-8.1 months)	None.

Grain sorghum, grain (RAC)	Stored at ambient temperatures at the field
site until delivered to processor within one day of harvest.

Stored frozen (temperature unspecified) at the processing facility.

Stored frozen (-20 ± 5 ºC) at the analytical facility.	247 days2

 (8.1 months)	None.

Grain sorghum, AGF

237 days2

(7.8 months)	None.

Grain sorghum, flour

246 days2

(8.1 months)	None.

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

  SEQ CHAPTER \h \r 1 2 Actual storage duration from
collection/processing to analysis; samples were processed within 8-17
days of harvest and analyzed within 1 day of extraction.

Conclusions:  The data for grain sorghum are classified as
scientifically acceptable pending submission of freezer storage
stability data for residues of novaluron in/on grain sorghum forage,
grain, AGF, and stover for up to 275, 253, 237, and 245 days,
respectively.  Although this is a deficiency, HED recommends a
conditional registration for the use of novaluron on grain sorghum. 
This decision is based on previously submitted storage stability data
for various commodities which demonstrates the stability of novaluron
in/on food commodities for up to 15.3 months, which exceeds the longest
storage time (9.0 months for grain sorghum forage) of the grain sorghum
commodities in the field trials.  The residue chemistry database will
support an unconditional registration upon submission of adequate
storage stability data along with revised Sections B and F.    

860.1480 Meat, Milk, Poultry, and Eggs

Livestock dietary burdens

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

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

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

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

The potential for secondary transfer of novaluron residues of concern in
meat, milk, and eggs exists because there are livestock feedstuffs
associated with the proposed/registered novaluron uses.  The livestock
dietary burdens of novaluron are presented in Table 5 and reflect the
most recent guidance from HED (Table 1, 6/08) concerning revisions of
feedstuff percentages and constructing RBDBs.  

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

Feedstuff	Type2	% Dry Matter2	% Diet3	Recommended Tolerance (ppm)
Dietary Contribution (ppm)4

Beef Cattle

Sorghum, grain, stover	R	88	15	40.0	6.82

Sorghum, grain, grain	CC	86	35	3.0	1.22

Sugarcane, molasses	CC	75	5	0.5	0.033

Grains, aspirated fractions	CC	85	5	25	1.47

Untreated	CC	--	35	--	--

Cottonseed, meal    	PC	89	5	0.60	0.034

TOTAL BURDEN	--	--	100	--	9.6

Dairy Cattle5

Sorghum, grain, forage	R	35	40	6.0	6.86

Sorghum, grain, stover	R	88	5	40.0	2.27

Sorghum, grain, grain	CC	86	35	3.0	1.22

Apple, wet pomace	CC	40	10	8.0	2.0

Cotton, undelinted seed	PC	88	10	0.60	0.068

TOTAL BURDEN	--	--	100	--	12.4

Poultry

Sorghum, grain, grain	CC	86	75	3.0	2.25

Cottonseed, meal 	PC	89	20	0.60	0.12

Untreated	PC	--	5	--	--

TOTAL BURDEN	--	--	100	--	2.4

Swine

Sorghum, grain, grain	CC	86	80	3.0	2.4

Untreated	CC	--	5	--	--

Cottonseed, meal 	PC	89	15	0.60	0.09

TOTAL BURDEN	--	--	100	--	2.5

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

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

3 OPPTS 860.1000 Table 1 Feedstuffs (June 2008).  

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

5 Petition 8E7425 (Memo, J. Van Alstine, 09-SEP-2009; D357060) included
a request for the use of novaluron on turnip greens; HED requested that
the petitioner submit a new label which prohibits the use of novaluron
on turnips harvested for the root and prohibits the feeding of turnip
tops to livestock.

Expected secondary residues in ruminant meat and milk

To determine the need for revisions to the tolerances for novaluron
residues of concern in milk and tissues, the anticipated secondary
residues in cattle matrices were estimated using average transfer
coefficients calculated from the maximum residues of novaluron observed
at the 3.9-, 12.6-, and 42.8-ppm dose levels (PP#2F6430).  The transfer
coefficients (calculated as residue-level-to-feed ratios) are presented
in Table 6.  The transfer coefficient for each matrix was then used to
calculate the expected secondary residues by multiplying the average
transfer coefficient by the calculated dietary burden (Tables 7 and 8). 

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

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

Whole milk	0.17, 0.43, 2.07	3.9, 12.6, 42.8

	0.044, 0.034, 0.048, (0.042)

Muscle	0.09, 0.34, 0.56

0.023, 0.027, 0.013, (0.021)

Kidney	0.14, 0.35, 1.20

0.036, 0.028, 0.028, (0.031)

Liver	0.14, 0.41, 1.36

0.036, 0.033, 0.032, (0.034)

Fat (peritoneal)	2.25, 6.83, 12.89

0.577, 0.542, 0.301, (0.473)

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

Matrix	Dietary burden (ppm)	Secondary Residues (ppm)1	Established
Tolerance (ppm)	Recommended Tolerance (ppm)

Whole milk	12.4	0.52	1.0	1.0

Muscle

0.26	0.60	0.60

Kidney

0.38	1.0	1.0

Liver

0.41	1.0	1.0

Fat (peritoneal)

5.87	11	11

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

Table 8.  Expected Secondary Residues in Hog Meat.

Matrix	Dietary burden (ppm)	Secondary Residues (ppm)1	Established
Tolerance (ppm)	Recommended Tolerance (ppm)

Muscle	2.5	0.05	0.01	0.07

Kidney

0.08	0.012	0.10

Liver

0.08	0.012	0.10

Fat (peritoneal)

1.2	0.05	1.5

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

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

Expected secondary residues in poultry meat and eggs

To determine the need for tolerances for novaluron residues of concern
in poultry meat and eggs, the anticipated secondary residues in poultry
matrices were estimated using average transfer coefficients calculated
from the maximum residues of novaluron observed in the hen metabolism
study (0.12-, 0.36-, 1.2-ppm dose levels; PP#2F06430).  The transfer
coefficients (calculated as residue-level-to-feed ratios) are presented
in Table 9.  The transfer coefficient for each matrix was then used to
calculate the expected secondary residues by multiplying the average
transfer coefficient by the calculated dietary burden (Table 10).  

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

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

Eggs (day 54)	0.063, 0.181, 0.702	0.12, 0.36, 1.2	0.52, 0.50, 0.58,
(0.53)

Muscle	0.014, 0.031, 0.160

0.12, 0.086, 0.13, (0.11)

Liver	0.034, 0.096, 0.364

0.28, 0.27, 0.30, (0.28)

Kidney	0.039, 0.089, 0.368

0.32, 0.25, 0.31, (0.29)

Fat (abdominal)	0.323, 0.988, 3.011

2.7, 2.7, 2.5, (2.6)

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

Matrix	Dietary burden (ppm)	Secondary Residues (ppm)1	Established
Tolerance (ppm)	Recommended Tolerance (ppm)

Eggs (day 54)	2.4	1.3	0.05	1.5

Muscle

0.27	0.03	0.40

Liver

0.68	0.042	0.80

Kidney

0.70	0.042	0.80

Fat (abdominal)

6.4	0.40	7.0

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

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

Conclusions:  The currently established livestock tolerances are based
on the following RBDBs for novaluron:  5.9 ppm for beef cattle, 2.3 ppm
for dairy cattle, 0.12 for poultry, and 0.09 for swine (Memo G. Kramer,
07-FEB-2008; D340137).  Based on the proposed/registered uses, the
revised RBDBs for novaluron are 9.6 ppm for beef cattle, 12.4 ppm for
dairy cattle, 2.4 for poultry, and 2.5 for swine.  This increase in the
RBDBs necessitates an increase in the tolerances for secondary residues
in/on poultry and hog commodities; however, no changes are necessary for
the tolerances for secondary residues in/on cattle, goat, horse, and
sheep.  The revised tolerances for residues of novaluron in hog and
poultry are as follows:  0.07 ppm in hog meat; 0.10 ppm in hog liver,
kidney, and meat byproducts; 1.5 ppm in hog fat; 1.5 ppm in eggs; 0.40
ppm in poultry meat; 0.80 ppm in poultry liver, kidney, and meat
byproducts; and 7.0 ppm in poultry fat.  The petitioner is requested to
submit a revised Section F reflecting these tolerances.

860.1500 Crop Field Trials

Grain Sorghum

DER Reference:  47727201.de1.doc

Twelve grain sorghum field trials were conducted in the U.S. during the
2007 growing season.  Trials were conducted in North American Free Trade
Agreement (NAFTA) Growing Zones 2 (NC; 1 trial), 4 (AR; 1 trial), 5 (IL,
KS, and NE; 4 trials), 6 (OK and TX; 1 trial each), 7 (NE, 1 trial), and
8 (KS, OK, and TX; 1 trial each).

Each trial site consisted of one untreated plot and one treated plot. 
The treated plots received three broadcast spray applications of a 0.83
lb/gal EC formulation of novaluron (EPA Reg. No. 66222-35) at
0.076-0.081 lb ai/A per application, with 7- to 15-day RTIs, for a total
rate of 0.232-0.239 lb ai/A; forage samples were harvested after only
two applications, for a total rate of 0.156-0.160 lb ai/A.  Applications
were made using ground equipment in approximately 20-34 GPA spray
volumes, without an adjuvant.  Samples of grain sorghum forage, grain,
and stover were taken at normal harvest times, 6 to 7 days after the
second application for forage and 13 to 14 days after the last
application for grain and stover.  At the OK2 trial, cattle destroyed
the crop after the second application and no grain or stover samples
could be harvested.  To evaluate residue decline, additional treated
samples were also collected at the NE2 trial 1, 3, 10, and 14 days after
the second application (forage) and 10, 14, 17, and 21 days after the
last application (grain and stover).

The results (see Table 11) indicate that residues of novaluron ranged
from 0.620 to 4.82 ppm in/on 24 samples of treated sorghum forage
harvested 6-7 days following foliar treatments with the 0.83 lb/gal EC
formulation at a total rate of 0.156-0.160 lb ai/A.  Novaluron residues
ranged from 0.586 to 1.96 ppm in/on 22 samples of treated sorghum grain,
and from 3.62 to 26.0 ppm in/on 22 samples of treated sorghum stover
(adjusted to 88% dry matter) harvested 13-14 days following foliar
treatments at a total rate of 0.232-0.239 lb ai/A.

In the residue decline trial, average residues of novaluron generally
decreased in/on forage, from 4.0 ppm at the 1-day PHI to 2.0 ppm at the
14-day PHI, and stover, from 6.7 ppm at the 7-day PHI to 3.8 ppm at the
21-day PHI; average residues in/on grain were approximately the same at
all sampling intervals.

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

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

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

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

Sorghum grain	0.232-0.239	13-14	22	0.586	1.96	1.84	1.16	1.23	0.43

Sorghum stover2

13-14	22	3.62	26.0	24.0	10.7	12.6	6.23

1 HAFT = highest-average field trial.

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

Conclusions:  The number and locations of field trials are in accordance
with OPPTS Guideline 860.1500 for grain sorghum; however, as described
above, grain and stover were not collected from one of the trials
because cattle destroyed the crop after the second novaluron
application.  The field trial data reflect the proposed use rate and PHI
for grain sorghum.  

The field trial data for grain sorghum forage, grain, and stover
(adjusted to 88% dry matter) were entered into the Agency’s tolerance
spreadsheet as specified by the Guidance for Setting Pesticide
Tolerances Based on Field Trial Data Standard Operating Procedure (SOP)
to determine appropriate tolerance levels; see Appendix I.  The
available data support the proposed tolerances of 6.0 ppm, 3.0 ppm, and
40 ppm for residues of novaluron in/on grain sorghum forage, grain, and
stover, respectively.

860.1520 Processed Food and Feed

There are processed commodities associated with grain sorghum and a
processing study on grain sorghum AGF and flour was submitted.

Grain Sorghum AGF and Flour

DER Reference:  47727201.de2.doc

To determine the potential for residues of novaluron to concentrate
in/on grain sorghum AGF and flour, sorghum plants at a single trial
conducted in TX (NAFTA Growing Zone 6) during the 2007 growing season
received three foliar broadcast applications of a 0.83 lb/gal EC
formulation of novaluron (EPA Reg. No. 66222-35) at 0.078 lb
ai/A/application, with 9- to 11-day RTIs, for a total rate of 0.234 lb
ai/A.  Applications were made using ground equipment in ~29 GPA spray
volumes, without an adjuvant.  Bulk samples of sorghum grain RAC were
harvested 13 days following the last application and processed using
simulated commercial procedures into AGF and flour.  

Residues of novaluron in/on grain were 1.20 ppm and residues were 16.0
and 0.795 ppm, respectively, in AGF and flour.  These data indicate that
residues of novaluron concentrate in AGF (13X) but do not concentrate in
flour (processing factor of 0.66X).  Sorghum flour is not considered to
be a human food item in the U.S.

Conclusions:  For grain sorghum AGF, the processed food data are
classified as scientifically acceptable pending submission of freezer
storage stability data for grain sorghum grain and AGF.  A tolerance
value of 25 ppm [i.e., 1.84 ppm (HAFT) x 13 = 24 ppm] was calculated for
AGF.  

  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
commodities associated with the current petitions may be rotated.  The
available confined rotational crop study is adequate (Memo, G. Kramer,
22-MAR-2004; D285474).  In the submitted confined rotational crop study,
the application rate (~0.089 lb ai/A) of the test substance was
equivalent to 0.3X the maximum proposed seasonal rate of application
(0.27 lb ai/A) for cotton and potatoes.  HED generally requires that the
confined rotational crop study be conducted at 1.0X the proposed maximum
seasonal rate for annual crops (or crops which can be rotated). 
However, as the total radioactive residue (TRR) was <0.005 ppm in all of
the rotated crop commodities, it is unlikely that significant residues
would be present at 1X.  Based on the results of the confined rotational
crop study, the appropriate PBI for all non-labeled crops is 30 days
(Memo, G. Kramer, 22-MAR-2004; D285474).  The current and proposed
labels include a restriction that only registered crops may be rotated
to a treated field within 30 days of the final application.  The HED
MARC has determined that for tolerance assessment and risk assessment,
parent only is the residue of concern (Memo, G. Kramer et al.,
03-FEB-2004; D297646).  

An additional field rotational crop study was submitted and considered
incomplete because certain rotational crop commodities (turnip tops and
wheat forage, hay, and grain) were not analyzed or included in the study
and crops were planted at only one location (Memo, G. Kramer, 07-FEB-08;
D379033).  Although incomplete, the data did demonstrate that it is
unlikely that residues of novaluron would accumulate at ≥0.05 ppm
(LOQ) in/on rotated turnip roots and wheat straw planted ~30, 60, or 90
days following treatment of primary crops at 0.9-1X the maximum seasonal
rate.  No additional field rotational crop data will be required as the
current and proposed labels include a restriction that only registered
crops may be rotated to a treated field within 30 days of the final
application.

860.1550 Proposed Tolerances

HED has determined that the residue of concern in plants for tolerance
enforcement is novaluron only.  A summary of HED’s recommended
tolerances for the current petition are listed in Table 12.  A revised
Section F is requested which reflects HED’s recommended tolerances and
commodity definitions presented in Table 12.  

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

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

Table 12.  Tolerance Summary for Novaluron.

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

Correct Commodity Definition

Grain sorghum, grain		3  	3.0  	Sorghum, grain, grain

Grain sorghum, aspirated grain fractions	25	25  	Grain, aspirated
fractions

Grain sorghum, forage		6	6.0  	Sorghum, grain, forage

Grain sorghum, stover		40  	40  	Sorghum, grain, stover

Poultry, fat		7.0	7.0  

	Poultry, muscle	0.4	0.40  	Poultry, meat	

Poultry, liver	0.8	0.80  

	Poultry, kidney		0.8	0.80  

	--	--	0.80  	Poultry, meat byproducts

Hog, fat		1.5	1.5  

	Hog, muscle	0.07	0.07  	Hog, meat	

Hog, liver		0.15	0.10  

	Hog, kidney		0.15	0.10  

	--	--	0.10	Hog, meat byproducts

Eggs	1.5	1.5  	Egg	

References

  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

DP#:		D357060

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

From:	J. L. Van Alstine

To:	D. Rosenblatt /L. Nollen	

Date:	09/09/09

DP#:		D364237		

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

From:	J. L. Van Alstine

To:	B. Madden/L. Nollen	

Date:		12/04/09

  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 (25-JAN-10), RAB1 Chemists (27-JAN-10)

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:  

DP#:  

Other Identifier: Decision Numbers: 

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

	Residue definition:  Novaluron only

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

Grain sorghum, grain	3

Grain sorghum, aspirated grain fractions	25

Grain sorghum, forage	6

Grain sorghum, stover	40

Poultry, fat	7.0

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

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

Poultry, kidney	0.8

Hog, fat	1.5

Meat (mammalian other than marine)	10 (fat)	Hog, meat	0.07

Hog, liver	0.15

Hog, kidney	0.15

Eggs	0.01 (*)	Eggs	1.5

Limits for Canada	Limits for Mexico

 No Limits

 No Limits for the crops requested	 No Limits

√  No Limits for the crops requested

Residue definition: 

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

	Residue definition:  novaluron

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

Meat of hogs	0.01

Meat byproducts of hogs	0.01

	Notes/Special Instructions:  

S.Funk, 10/16/2009.

* = absent at or about the limit of quantitation.

Appendix I.  Tolerance-Assessment Calculations.

Grain Sorghum Forage, Grain, and Stover

The dataset used to establish a tolerance for novaluron on grain sorghum
consisted of field trial data for forage, grain, and stover.  The forage
field trial data represented application rates of 0.156-0.160 lb ai/A (2
applications at 0.077-0.081 lb ai/A per application) with a 6- to 7-day
PHI.  The grain and stover field trial data represented application
rates of 0.232-0.239 lb ai/A (3 applications at 0.076-0.080 lb ai/A per
application) with 13- to 14-day PHIs.  As specified by the Guidance for
Setting Pesticide Tolerances Based on Field Trial Data (SOP), the field
trial application rates and PHIs are within 25% of the maximum label
application rate and minimum label PHI, respectively.  The residue
values that were entered into the tolerance spreadsheet are provided in
Tables I.1, I.2, and I.3.

The grain sorghum forage, grain, and stover datasets were entered into
the tolerance spreadsheet as specified by the Guidance for Setting
Pesticide Tolerances Based on Field Trial Data SOP.  Grain sorghum
stover residues were adjusted to 88% dry matter.  All field trial sample
results for forage, grain, and stover were above the LOQ (lowest level
of method validation (LLMV) = 0.05 ppm).  Visual inspection of the
lognormal probability plots (Figures I.3; I.5) and the results from the
approximate Shapiro-Francia test statistic (Figure; I.4; I.6) indicated
that the dataset was reasonably lognormal for grain sorghum grain and
stover.  Visual inspection of the lognormal probability plot (Figure
I.1) and the Shapiro-Francia test statistic (Figure I.2) for sorghum
forage indicated that the lognormality assumption should be rejected for
grain sorghum forage.  

Since the field trial data for novaluron on grain sorghum grain and
stover represent a large dataset (i.e., more than 15 samples) and are
reasonably lognormal, the minimum of the 95% upper-confidence limit
(UCL) on the 95th percentile and the point estimate of the 99th
percentile should be selected as the tolerance value.  Using the
rounding procedure as outlined in the SOP, the 95% UCL on the 95th
percentile rounds to the values 3.0 ppm and 40 ppm and the point
estimate of the 99th percentile rounds to the values 3.0 ppm and 40 ppm
for grain sorghum grain and stover, respectively (Figures I.4; I.6). 
For grain sorghum forage, the mean + 3 SD rounds to 6.0 ppm (Figure
I.2).  Therefore, 6.0 ppm, 3.0 ppm, and 40 ppm are the recommended
tolerance levels for novaluron in/on grain sorghum forage, grain, and
stover.  

Table I.1.  Residue Data Used to Calculate Tolerance for Novaluron in/on
Sorghum, Grain, Forage.

Regulator:	EPA

Chemical:	Novaluron (0.83EC Formulation)

Crop:	Sorghum, Grain, Forage

PHI:	6-7 Days

App. Rate:	0.156-0.160 lb ai/A

Submitter:	MANA/Chemtura

MRID Citation:	47727201

	Residues of Novaluron (ppm)

	3.4

	4.58

	1.78

	1.84

	2.68

	2.85

	2.18

	2.5

	2.7

	4.18

	2.06

	2.36

	2.82

	4.18

	2.62

	3.82

	1.51

	2.21

	0.62

	0.848

	2.02

	2.12

	3.65

	4.82

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

 

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

 

Table I.2.  Residue Data Used to Calculate Tolerance for Novaluron in/on
Sorghum, Grain, Grain.

Regulator:	EPA

Chemical:	Novaluron (0.83EC Formulation)

Crop:	Sorghum, Grain, Grain.

PHI:	13-14 Days

App. Rate:	0.232-0.239 lb ai/A

Submitter:	MANA/Chemtura

MRID Citation:	47727201

	Residues of Novaluron (ppm)

	0.586

	0.624

	0.638

	0.719

	0.91

	1.47

	1.74

	1.94

	0.997

	1.05

	1.32

	1.55

	1.05

	1.07

	0.935

	1.26

	1.07

	1.25

	1.69

	1.85

	1.42

	1.96

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

 

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

 

Table I.3.  Residue Data Used to Calculate Tolerance for Novaluron in/on
Sorghum, Grain, Stover.

Regulator:	EPA

Chemical:	Novaluron (0.83EC Formulation)

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

PHI:	13-14 days

App. Rate:	0.232-0.239 lb ai/A

Submitter:	MANA/Chemtura

MRID Citation:	47727201

	Residues of Novaluron (ppm)

	22.07

	25.96

	8.20

	9.78

	14.80

	15.21

	9.06

	12.46

	11.49

	16.66

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	5.39

	16.70

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	3.62

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	7.19

	8.61

	9.93

	19.90

	20.71

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

 

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

 

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

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