Document ID: EPA-HQ-OPP-2014-0232-0008
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2015-07-22T04:00Z

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
                               WASHINGTON, D.C.  20460
                                       
                                                                     	OFFICE OF
                                                            CHEMICAL SAFETY AND
                                                           POLLUTION PREVENTION

MEMORANDUM

Date:		16-JUN-2015

SUBJECT:	Novaluron.  Petition for the Establishment of Permanent Tolerances for Residues of Novaluron in/on Avocado; Carrot; Bean, Succulent; Crop Group Conversion to Vegetable, Fruiting, Crop Group 8-10; Fruit, Pome, Crop Group 11-10; Cherry Subgroup 12-12A; Peach Subgroup 12-12B; and Plum Subgroup 12-12C; and Revisions to the Label to Include Uses on Greenhouse-Grown Cucumber.  Summary of Analytical Chemistry and Residue Data.

PC Code:  124002
DP Barcodes:  D418739; D390527; D382524
Decision Nos.:  487502; 449929; 
                          437876
Registration Nos.:  66222-35; 11678-57
Petition No.:  4E8241
Regulatory Action:  Section 3
Risk Assessment Type:  NA
Case No.:  7615
TXR No.:  NA
CAS No.:  116714-46-6
MRID Nos.:  48482701; 48156601; 49303201-49303204
40 CFR:  §180.598

FROM:	Julie L. Van Alstine, MPH, Environmental Health Scientist
		Risk Assessment Branch 1 (RAB1)/Health Effects Division (HED; 7509P)

THROUGH:	George F. Kramer, Ph.D., Senior Chemist
		RAB1/HED (7509P)

      And

		Douglas Dotson, Ph.D., Chemist
		Peter Savoia, Chemist
		Chemistry Science Advisory Council (ChemSAC; HED; 7509P)	

TO:		Barbara Madden (RM 05)/Laura Nollen/Sidney Jackson
		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 (IGRs).  It is currently registered for use on various fruit and vegetable crops.  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 PP#4E8241, the Interregional Research Project No. 4 (IR-4) requests the establishment of 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:
         
         Avocado	0.60 ppm
         Carrot	0.05 ppm
         Bean	 0.60 ppm
         Vegetable, fruiting, group 8-10	1.0 ppm
         Fruit, pome, group 11-10	2.0 ppm
         Cherry subgroup 12-12A	8.0 ppm
         Peach subgroup 12-12B	1.9 ppm
         Plum subgroup 12-12C	1.9 ppm

The end-use product associated with these registration requests is Rimon[(R)] 0.83EC Insecticide (EPA Reg. No. 66222-35) which contains 9.3% ai by weight [equivalent to 0.83 pound (lb) ai/gallon (gal)].  No new data were submitted to support tolerances on fruiting vegetable group 8-10, pome fruit group 11-10, cherry subgroup 12-12A, peach subgroup 12-12B, and plum subgroup 12-12C.  For these registrations, the petitioner has requested that existing tolerances be expanded to their updated crop group commodity definitions.  A tolerance has already been established for residues of novaluron in/on cucurbit vegetable group 9; however, use of Rimon[(R)] 0.83EC on greenhouse-grown cucumbers is excluded.  The petitioner has provided field trial data to expand the use pattern to include greenhouse-grown cucumbers.    

The proposed new uses, as summarized in Section B of the petition, are as follows:  1) Avocado:  a maximum application rate of 0.375 lb ai/acre (up to 3 applications of 0.125 lb ai/A) with a 14-day retreatment interval (RTI) and a 1-day preharvest interval (PHI); 2) Succulent and Dry Beans:  a maximum application rate of 0.233 lb ai/acre (up to 3 applications of 0.039-0.078 lb ai/A) with a 7-day RTI and a 1-day PHI;  and 3) Carrots:  a maximum application rate of 0.239 lb ai/acre (up to 3 applications of 0.079 lb ai/A) with a 7-day RTI and a 3-day PHI.  There are no proposed application-rate changes for cucurbits, fruiting vegetables, pome fruit, and stone fruit.  A revised Section B is required that updates the pear application-rate information so that the maximum seasonal application rate and maximum numbers of applications are concordant and indicates that the product may be used on "beans, succulent" and "beans, dry" instead of the proposed "beans."    

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 proposed label includes 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 the residue tolerances associated with this petition.  For novaluron residue analysis in crop matrices, 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 avocado, carrot, cucumber, and lima bean were analyzed for residues of novaluron using a GC/ECD method that is similar to the enforcement method.  Acceptable concurrent method recovery and validation 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 were submitted for avocado, carrot, cucumber, and lima bean.  These data demonstrate that residues of novaluron were stable for the durations for which the field trial samples were frozen.  HED previously requested storage stability data on dried plums and on grain sorghum forage, grain, aspirated grain fractions (AGF), and stover.  Acceptable dried plum and sorghum grain and forage storage stability data have been submitted; therefore, these deficiencies are now resolved.

The submitted field trial residue data for avocado, carrot, cucumber, and lima bean are adequate to support the establishment of the requested tolerances.  Although only five independent lima bean field trials were submitted, an additional field trial is not being required since HED does not expect that the submission of an additional lima bean field trial would result in a higher recommended tolerance for residues of novaluron in/on succulent beans.  The remaining proposed tolerances pertain to updates to the crop group/subgroup commodity definitions.  Since the proposed application rates are identical to or lower than the rates previously reviewed, no residue data were submitted and none are required.  

There are no processed commodities associated with avocado, carrot, cucumber, and lima bean.  Although there are processed commodities associated with fruiting vegetables, pome fruit, and stone fruit, processing studies were not required since the petitioner has requested updates to the crop group commodity definitions which are supported with previously submitted data, including processing studies.  

The field trial data for avocado, greenhouse-grown cucumber, and lima bean were entered into the Organization for Economic Cooperation and Development (OECD) tolerance calculator to determine the appropriate tolerance level.  The OECD tolerance calculation procedures were not used for carrot because all of the residues were less than the lowest level of method validation (LLMV; 0.05 ppm).  The output from the tolerance calculator and the submitted field trial data support the HED-recommended tolerances outlined in Table 1.  

Carrot culls, a carbohydrate concentrate, are the only livestock feed item associated with the current petition.  The incorporation of carrot culls into the reasonably balanced dietary burden (RBDB) calculations did not result in increased livestock dietary burdens.  As a result, revised RBDBs and livestock tolerances were not required.  

No Canadian, Codex, or Mexican MRLs have been established for residues of novaluron in/on avocado and carrot.  Codex has established the following MRLs for residues of novaluron: 0.7 ppm on common bean (pods and/or immature seeds); 0.7 ppm on fruiting vegetables other than cucurbits; 3 ppm on pome fruit; 3 ppm on prunes; 7 ppm on stone fruits; and 0.2 ppm on fruiting vegetables and cucurbits.  Canada has established the following MRLs for residues of novaluron:  0.6 ppm on edible-podded snap beans; 0.8 ppm on bell peppers; 0.9 ppm on non-bell peppers; 2 ppm on apples, Asian pears, crabapples, loquats, mayhaws, pears, and quinces; 2.6 ppm on plum, prune, dried; 8 ppm on sweet and tart cherries; and 1.9 ppm on apricots, fresh prune plums, nectarines, peaches, plumcots, and plums.  HED is recommending to harmonize residues with Codex for the following commodities and crop groups: bean, succulent (0.70 ppm); vegetable, cucurbit, group 9 (0.20 ppm); fruit, pome, group 11-10 (3.0 ppm); and plum, prune, dried (3.0 ppm).  

Regulatory Recommendations and Residue Chemistry Deficiencies

Pending submission of revised Sections B and F, there are no residue chemistry issues that would preclude granting a registration for the requested uses of Rimon[(R)] 0.83EC Insecticide and the following permanent tolerances, as outlined in Table 1, under 40 CFR §180.598(a).  

Table 1.  Tolerance Summary for Novaluron.
Commodity
                           Proposed Tolerance (ppm)
                        HED-Recommended Tolerance (ppm)
Comments; 
Correct Commodity Definition
Avocado
                                     0.60
                                     0.60

Carrot
                                     0.05
                                     0.05

Bean
                                     0.60
                                     0.70
Harmonize with Codex MRL 
Bean, succulent[1]
Vegetable, fruiting, group 8-10[2]
                                      1.0
                                      1.0

Fruit, pome, group 11-10[3]
                                      2.0
                                      3.0
Harmonize with Codex MRL 
Cherry subgroup 12-12A[4]
                                      8.0
                                      8.0

Peach subgroup 12-12B[5]
                                      1.9
                                      1.9

Plum subgroup 12-12C[5]
                                      1.9
                                      1.9

Vegetable, cucurbit, group 9
                                      --
                                     0.20
Harmonize with Codex MRL 
Plum, prune, dried
                                      --
                                      3.0
Harmonize with Codex MRL 
[1] This tolerance will replace the existing tolerance of 0.60 ppm on bean, succulent, snap.  The dry bean tolerance will not be impacted.  
[2] This tolerance will replace the existing tolerances of 1.0 ppm on vegetable, fruiting, group 8, and also cocona, African eggplant, pea eggplant, scarlet eggplant, goji berry, garden huckleberry, martynia, naranjilla, okra, roselle, sunberry, bush tomato, currant tomato, and tree tomato. 
[3] This tolerance will replace the existing tolerance of 2.0 ppm on fruit, pome, group 11. 
[4] This tolerance will replace the existing tolerance of 8.0 ppm on cherry. 
[5] These tolerances will replace the existing tolerance of 1.9 ppm on fruit, stone, group 12, except cherry.
            
Note to RD:  With the establishment of these tolerances, the following tolerances should be removed from 40 CFR §180.598(a):  bean, succulent, snap; vegetable, fruiting, group 8; cocona; African eggplant; pea eggplant; scarlet eggplant; goji berry; garden huckleberry; martynia; naranjilla; okra; roselle; sunberry; bush tomato; currant tomato; tree tomato; fruit, pome, group 11; cherry; and fruit, stone, group 12, except cherry.

A human health risk assessment is forthcoming in a separate document (D426068).

860.1200  Directions for Use
A revised Section B for PP#4E8241 should be submitted which:
   * Updates the pear application-rate information so that the maximum seasonal application rate and maximum numbers of applications are concordant.  The proposed label implies that up to two 32-ounce applications may be made per season, which would result in a maximum seasonal rate of 64 ounces (~0.4 lb ai/A/season); however, the label specifically indicates that the maximum seasonal application rate is 96 ounces (~0.6 lb ai/A/season; equivalent to 3 applications).  The field trial data support a maximum seasonal application rate of 0.97 lb ai/A.
   * Indicates that the product may be used on "beans, succulent" and "beans, dry" instead of the proposed "beans."  

860.1550 Proposed Tolerances
A revised Section F for PP#4E8241 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]amino]carbonyl]-2,6-difluorobenzamide) in or on the following raw agricultural commodities:"; and

   * Reflects the recommended tolerances and commodity definitions presented in Table 1.  

860.1650 Submittal of Analytical Reference Standards
An analytical standard for novaluron is currently available in the National Pesticide Standards Repository (electronic communication from T. Cole to J. Van Alstine, 29-JAN-2015).  However, the standard has an expiration date of 07-MAR-2015.  A new reference standard should be sent to the Analytical Chemistry Lab, which is located at Fort Meade, to the attention of either Theresa Cole or Thuy Nygen at the following address:

	USEPA
	National Pesticide Standards Repository/Analytical Chemistry Branch/OPP
	701 Mapes Road
	Fort George G. Meade, MD  20755-5350

(Note that the mail will be returned if the extended zip code is not used.)

Background

Novaluron, N-[[[3-chloro-4-[1,1,2-trifluoro-2-(trifluoromethoxy)ethoxy]phenyl]amino] carbonyl]- 2,6-difluorobenzamide, is a pesticide chemical belonging to the IGR class of insecticides.  IGRs kill the insects over a period of a few days by disrupting the normal growth and development of immature insects.  Novaluron acts as an insecticide mainly by ingestion, but has some contact activity.  The chemical structure and nomenclature of novaluron are listed in Table 2.  The physicochemical properties of the technical grade of novaluron are presented in Table 3.

Table 2.  Novaluron Nomenclature.
Chemical structure
                                       
Common name
Novaluron
IUPAC name
1-[3-chloro-4-(1,1,2-trifluoro-2-trifluoromethoxyethoxy)phenyl]-3-[2,6-difluorobenzoyl]urea
CAS name
N-[[[3-chloro-4-[1,1,2-trifluoro-2-(trifluoromethoxy)ethoxy]phenyl]amino]carbonyl]-2,6-difluorobenzamide
CAS registry number
116714-46-6
End-use products (EPs)
Rimon[(R)] 0.83EC Insecticide (0.83 lb/gal EC; EPA Reg. No. 66222-35)

Table 3.  Physicochemical Properties of Technical Grade Novaluron.
Parameter
Value
Reference
Melting range
176.5 - 178.0C
DP# 315780, 3-NOV-2005, S. Levy
pH
6.5

Density
1.56 g/cm[3] at 22C

Water solubility
3 μg/L at 20C

Solvent solubility (at 25C)
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 25C

UV/visible absorption spectrum
Molar absorption coefficients 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

Table 4.  Summary of Directions for Proposed Use of Novaluron.
                     Applic. Timing, Type, and Equip.[†]
                          Formulation [EPA Reg. No.]
                          Max Applic. Rate (lb ai/A)
                          Max. No. Applic. per Season
                    Max. Seasonal Applic. Rate (lb ai/A)[1]
                                  PHI (days)
                        Use Directions and Limitations
                                 Proposed Uses
                                    Avocado
                               Aerial, Airblast
                           Emulsifiable Concentrate
                                  [66222-35]
                                     0.125
                         3 (at max. single appl. rate)
                                    0.375 
                                       1
Use a minimum spray volume of 100 GPA
RTI:  14 days
                                    Carrot
                                Aerial, Ground
                           Emulsifiable Concentrate
                                  [66222-35]
                                     0.080
                         3 (at max. single appl. rate)
                                     0.240
                                       3
Use a minimum spray volume of 20 GPA
RTI: 7 days
                      Greenhouse Cucumbers              
                                  Ground, or
                           Handheld spray equipment
                           Emulsifiable Concentrate
                                  [66222-35]
                                0.059  -  0.078
                              Or 0.0008 lb ai/gal
                         3 (at max. single appl. rate)
                                     0.234
                                       1
The use of novaluron on crops grown for food in greenhouses, except tomatoes and cucumbers, is prohibited. 
Tomato RTI: 7 days 
Cucumber RTI: 14 days.  
Proposed Crop Group Expansion (Same Application Scenario that is Currently Registered)
                              Bean, Succulent[2]
                                Aerial, Ground
                           Emulsifiable Concentrate
                                  [66222-35]
                                 0.039 - 0.078
                         3 (at max. single appl. rate)
                                     0.234
                                       1
RTI:  7 days
Proposed Crop Group Commodity Updates (Same Application Scenarios that are Currently Registered)
                     Pears (Group 11-10 pear; Asian pear)
                                Aerial, Ground
                           Emulsifiable Concentrate
                                  [66222-35]
0.13  -  0.21
                      2 or 3 (at max. single appl. rate)
                                0.42 or 0.63[3]
                                      14
For use only in Colorado, Michigan, New York, Pennsylvania, Washington and Oregon.
Not registered in California
RTI:  10 days
Fruit, Pome, Group 11-10 Except Pears (Apple; azarole; crabapple; loquat; mayhaw; medlar; quince; Chinese quince; Japanese quince; tejocote; cultivars, varieties, and/or hybrids of these )
                                Aerial, Ground
                           Emulsifiable Concentrate
                                  [66222-35]
                                0.097  -  0.32
                         3 (at max. single appl. rate)
                                     0.97
                                      14
Not registered in California.
RTI:  10 days
 Stone Fruit (capulin; black cherry; Nanking cherry; sweet cherry; tart cherry; cultivars, varieties, and/or hybrids of these;  nectarine; peach; cultivars, varieties, and/or hybrids of these: apricot; Japanese apricot; Chinese jujube; plum; American plum; beach plum; Canada plum; cherry plum; Chickasaw plum; Damson plum; Japanese plum; Klamath plum; prune plum; plumcot; sloe; cultivars, varieties, and/or hybrids of these)
                                Aerial, Ground
                           Emulsifiable Concentrate
                                  [66222-35]
                                0.129  -  0.32
                       3 (at max. single appl. rate)[1]
                                     0.97
                                       8
Not registered in California.
RTI: 7 days
Vegetable, Fruiting, Group 8-10 [tomatoes (including bush, currant, and tree tomatoes), peppers, eggplants (including African, pea, and scarlet eggplants), tomatillo, groundcherry, pepino, okra, cocona, goji berry, garden huckleberry, martynia, naranjilla, roselle, and sunberry]
                                  Ground, or
                           Handheld spray equipment
                           Emulsifiable Concentrate
                                  [66222-35]
                                0.059  -  0.078
                              Or 0.0008 lb ai/gal
                         3 (at max. single appl. rate)
                                     0.233
                                       1
The use of novaluron on crops grown for food in greenhouses, except tomatoes and cucumbers, is prohibited. 
RTI: 7 days 
1 Maximum seasonal rates may not match the maximum application rate times the maximum number of applications due to rounding.
[2] Novaluron is already registered for use on succulent snap beans and dry beans.  Based on the submitted lima bean data, HED is recommending for a tolerance to be established in beans, succulent.  This will replace the succulent snap bean tolerance, but will not impact dry beans.  The use pattern is the same as what was previously registered.   
[3] It is not clear from the current label whether two applications or three applications may be made per season.  The label implies that two applications may be made; however, the maximum seasonal application rate is for three applications.  A revised label is required.  

Applications of Rimon[(R)] 0.83EC may also be made using aerial or ground equipment or through sprinkler irrigation systems; use of other types of irrigation systems is prohibited.  The accepted (master) label for Rimon[(R)] 0.83EC Insecticide states that only registered crops may be rotated in a treated field within 30 days of application.  The proposed label includes a restriction that only registered crops may be rotated to a treated field within 30 days of the final application and to prohibit the use of novaluron on crops grown for food in greenhouses, except tomatoes and cucumbers.  
 
Conclusions:  Novaluron is currently registered for use on vegetable, fruiting, group 8, cocona, African eggplant, pea eggplant, scarlet eggplant, goji berry, garden huckleberry, martynia, naranjilla, okra, roselle, sunberry, bush tomato, currant tomato, and tree tomato; fruit, pome, group 11; fruit, stone, group 12, except cherry; cherry; and plum, prune, dried.  The petitioner has requested that existing uses be expanded to fruiting vegetable group 8-10, pome fruit group 11-10, cherry subgroup 12-12A, peach subgroup 12-12B, and plum subgroup 12-12C, and the addition of greenhouse-grown cucumbers to the label.  The existing directions for use for these crops is unchanged other than the additional crops covered by the updated groups/subgroups.  Detailed reviews of the directions for use for these crops can be found in previous HED reviews (Memo, G. Kramer, 7-FEB-2008, D340137; Memo, J. Van Alstine, 04-DEC-2009; D364237; Memo, S. Levy, 03-NOV-2005, D322978; Memo, J. Van Alstine, 09-SEP-2009, D357060).

The proposed labels are adequate to allow evaluation of the residue data relative to the proposed new uses on avocado, carrot, all succulent beans, greenhouse-grown cucumbers, and the proposed updated crop groupings.  It is not clear from the proposed label whether two applications or three applications may be made to pears per season.  The label implies that two applications may be made; however, the maximum seasonal application rate corresponds to three applications.  The label should be updated so that the maximum seasonal application rate and maximum numbers of applications are concordant.  Additionally, the label should be revised to indicate that the product may be used on "beans, snap, succulent" and "beans, dry" instead of the proposed "beans."  A revised Section B is required.

860.1300 Nature of the Residue - Plants

MARC Decision Memo, DP# 297646, 3-FEB-2004, G. Kramer
Residue Chemistry Memo, DP# 285474, 22-MAR-2004, G. Kramer (PP#2F6430)

HED previously (PP#2F6430) concluded that the nature of the residue in plants is adequately understood based on acceptable metabolism studies conducted on apples, cabbage, cotton, and potatoes using [difluorophenyl-U-[14]C]novaluron and [chlorophenyl-U-[14]C]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 that 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, 22-MAR-2004, G. Kramer (PP#2F6430)
Residue Chemistry Memo, DP# 306998, 15-SEP-2004, S. Levy (PMV Results)
Residue Chemistry Memo, DP# 307595, 15-SEP-2004, S. Levy (PP#2F6430; Letter to FDA)
Residue Chemistry Memo, DP#s 322978 & 315780, 3-NOV-2005, S. Levy (PP#4E6834)
Residue Chemistry Memo, DP# 325183, 23-AUG-2006, S. Levy (PP#4E6834; Radiovalidation)

Enforcement Methods
MANA previously submitted under PP#2F6430 a GC/ECD residue analytical method for the analysis of residues of novaluron in/on pome fruit, cabbage, and potato commodities.  Briefly, residues in/on homogenized crop samples are extracted with methanol/water.  The filtered extracts are concentrated 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, and potatoes) and cotton, respectively.  ACB determined that the analytical methods do not need to be laboratory validated by EPA (Memo, S. Levy, 15-SEP-2004; DP306998).  Both methods have been forwarded to the FDA for inclusion in the PAM II as a Letter Method (Letter, S. Levy to the FDA), 15-SEP-2004; D307595).

Data Collection Methods
Avocado:  Residues of novaluron in/on avocado were quantitated by GC/ECD using the method entitled, "Magnitude of the Residue on Novaluron in Pome Fruit Raw Agricultural and Processed Commodities," with minor modifications.  For method validation, control samples of avocado were fortified with novaluron at 0.050-5.0 ppm.  Recoveries from avocado were 68-97% (84 +- 8%, n = 9).  Concurrent recoveries from control avocado samples fortified at 0.05-0.50 ppm were 70-100% (79 +- 7%, n = 8).  The lowest level of method validation (LLMV) for residues of novaluron in/on avocado samples was 0.050 ppm.  The calculated limit of detection (LOD) and LOQ were 0.00839 ppm and 0.0252 ppm, respectively.  

Carrot:  Residues of novaluron in/on carrot were quantitated by GC/ECD using the method entitled, "Magnitude of the Residue on Novaluron in Pome Fruit Raw Agricultural and Processed Commodities," with minor modifications.  For method validation, control samples of carrot were fortified with novaluron at 0.050-5.0 ppm.  Recoveries from carrot were 72-94% (82 +- 6%, n = 9).  Concurrent recoveries from control carrot samples fortified at 0.050-0.50 ppm were 74-102% (82 +- 8%, n = 8).  The LLMV for residues of novaluron in/on carrot samples was 0.050 ppm.  The calculated LOD and LOQ were 0.0175 ppm and 0.0524 ppm, respectively.  

Greenhouse-Grown Cucumbers:  Residues of novaluron in/on cucumber were quantitated by GC/ECD using the method entitled, "Magnitude of the Residue on Novaluron in Pome Fruit Raw Agricultural and Processed Commodities," with minor modifications.  For method validation, control samples of cucumber were fortified with novaluron at 0.050-5.0 ppm.  Method validation recoveries were in the range 90-110% (99 +- 6%, n = 9).  Concurrent recoveries from control samples fortified at 0.050-0.50 ppm and analyzed with the treated samples were in the range 95-109% (100 +- 5%, n = 6).  The LLMV for residues of novaluron in/on cucumber samples was 0.050 ppm.  The calculated LOD and LOQ were 0.0091 ppm and 0.027 ppm, respectively.

Lima Beans:  Residues of novaluron in/on lima beans were quantitated by GC/ECD using the method entitled, "Magnitude of the Residue on Novaluron in Pome Fruit Raw Agricultural and Processed Commodities," with minor modifications.  For method validation, control samples of lima bean were fortified with novaluron at 0.050-5.0 ppm.  Recoveries from lima beans were 87-104% (102 +- 5, n = 9).  Concurrent recoveries from control lima bean samples fortified at 0.050-0.50 ppm were 90-115% (100 +- 9, n = 6).  The LLMV for residues of novaluron in/on lima bean samples was 0.050 ppm.  The calculated LOD and LOQ were 0.013 ppm and 0.039 ppm, respectively.

Conclusions:  HED previously concluded that the submitted GC/ECD and HPLC/UV methods are adequate as an enforcement methods for novaluron, the terminal residue of concern in plants.  GC/ECD methods that are similar to the enforcement method were used for data collection, and the methods were adequately validated in conjunction with the avocado, carrot, greenhouse cucumber, and lima bean field trials.  

860.1360 Multiresidue Methods

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

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-2004, G. Kramer (PP#2F6430)
Residue Chemistry Memo, DP# 357060, 09-SEP-2009, J. Van Alstine (PP#8E7425)
Residue Chemistry Memo, DP# 364237, 04-DEC-2009, J. Van Alstine (PP#9E7546)

Storage stability data for novaluron were previously 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 were 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, Swiss chard for 11.7 months, and sweet corn kernel plus cob with husks removed (K+CWHR), forage, and stover for approximately 26 months.  

The avocado, carrot, cucumber, and lima bean samples were placed in frozen storage shortly after collection and remained frozen until analysis.  The maximum storage interval from harvest to extraction for analysis of the field-treated avocado raw agricultural commodity (RAC) samples in this study was 948 days.  A storage stability study on novaluron residues in/on frozen avocado was conducted in conjunction with the avocado magnitude of the residue study.  Storage stability samples fortified with novaluron at 0.50 ppm and held in frozen storage for 956 days under similar conditions to the field generated samples had corrected recoveries of 89-115%.

The maximum storage interval from harvest to extraction for analysis of the field-treated carrot RAC samples in this study was 816 days.  A storage stability study on novaluron residues in/on frozen carrot was conducted in conjunction with the carrot magnitude of the residue study.  Storage stability samples fortified with novaluron at 0.50 ppm and held in frozen storage for 824 days under similar conditions to the field generated samples had corrected recoveries of 83-89%.

The maximum storage interval from harvest to extraction during analysis of the greenhouse-grown cucumber RAC samples in this study was 445 days.  A storage stability study on novaluron residues in/on frozen cucumber was conducted in conjunction with the cucumber magnitude of the residue study.  Storage stability samples fortified with novaluron at 0.50 ppm and held in frozen storage for 454 days under similar conditions to the greenhouse-generated samples had corrected recoveries of 137-141%.

The maximum storage interval from harvest to extraction for analysis of the field-treated lima bean RAC samples in this study was 387 days.  A storage stability study on novaluron residues in/on frozen lima bean was conducted in conjunction with the lima bean magnitude of the residue study.  Storage stability samples fortified with novaluron at 0.50 ppm and held in frozen storage for 397 days under similar conditions to the field generated samples had corrected recoveries of 95-108%.

Table 5.  Summary of Storage Conditions.
                                 Matrix (RAC)
                                    Analyte
                         Storage Temperature (°C)[1]
                        Actual Storage Duration (days)
               Interval of Demonstrated Storage Stability (days)
                       Fresh Fortification Recovery (%)
                    Apparent Recovery in Stored Sample (%)
                    Corrected Recovery in Stored Sample (%)
                                    Carrot
                                   Novaluron
                                Generally <0
                                      816
                                      824
                                      92
                                  76, 82, 82
                                  83, 89, 89
                                   Lima Bean
                             (succulent bean seeds
                                 without pods)
                                       
                                    <-3
                                      387
                                      397
                                      87
                                  83, 87, 94
                                 95, 100, 108
                                    Avocado
                                       
                                   -38 to -1
                                      948
                                      956
                                      93
                                  83, 90, 107
                                  89, 97, 115
                                   Cucumber
                                       
                                  -37 to -11
                                      445
                                      454
                                      75
                                 103, 105, 106
                                 137, 140, 141
[1] On 10/13/09, the air temperature rose above 0 [o]C (at one time as high as +5 [o]C) for approximately one hour.  Samples remained frozen and there was no adverse impact on the study.

HED previously requested storage stability data on dried plums for up to 243 days (Memo, J. Van Alstine, 09-SEP-2009; D357078) and on grain sorghum forage, grain, AGF, and stover for up to 275, 253, 237, and 245 days, respectively (Memo, J. Van Alstine, 23-FEB-2010; D364307).  Acceptable storage stability data for these commodities have been submitted to the Agency and these deficiencies are now resolved (Dried Plum MRID 48482701; Sorghum MRID 48156601).  A summary of the submitted studies can be found in Appendix II.  

The fortified dried plums were analyzed for novaluron recoveries after storage periods of 0 days, 125 days, and 244 days.  Concurrent recoveries were 115% at 0 days, 71% at 125 days, and 76% and 104% at 244 days.  Since there is a large body of data indicating that residues of novaluron are typically stable during freezer storage, it was determined that the concurrent recovery value of 76% could be used to correct the recoveries of the samples stored 244 days.  The corrected recoveries for the storage stability samples were in the ranges of 95-97% at 0 days, 115-148% at 125 days, and 68-105% at 244 days.  These data indicate that novaluron is stable under the frozen storage conditions for up to 125 days, and then decline (but can still be recovered) when stored up to 244 days.  The dried plum storage stability deficiency has been resolved.  

The fortified, sorghum forage and grain samples were analyzed for novaluron recoveries after storage periods of 0 days, 193/194 days, and 277/278 days.  Mean concurrent recoveries were 101 +- 9% for sorghum forage and 105 +- 8% for sorghum grain.  The corrected recoveries for the storage stability samples were in the ranges of 89-93% at 193 days and 103-108% at 277 days for sorghum forage and 89-90% at 194 days and 100-104% at 278 days for sorghum grain.  These data indicate that novaluron is stable under the frozen storage conditions for up to 277 and 288 days in sorghum forage and grain, respectively.  HED requested data on grain sorghum forage, grain, AGF, and stover.  The submitted storage stability data on sorghum forage may be translated to sorghum stover and the sorghum grain data may be translated to sorghum AGF; therefore, the sorghum storage stability deficiencies are resolved.  

Table 6.  Summary of Storage Conditions for Dried Plum and Sorghum Forage and Grain.
                                 Matrix (RAC)
                                    Analyte
                              Storage Temp. (°C)
                        Actual Storage Duration (days)
               Interval of Demonstrated Storage Stability (days)
                       Fresh Fortification Recovery (%)
                    Apparent Recovery in Stored Sample (%)
                    Corrected Recovery in Stored Sample (%)
                                  Dried Plum
                                   Novaluron
                                   -31 to -1
                                      244
                                      244
                                     76[1]
                                  80, 65, 52
                                  105, 86, 68
                                Sorghum Forage
                                       
                                   -20 +- 5
                                      277
                                      277
                                90, 90 (90)[2]
                                    97, 93
                                   108, 103
                                 Sorghum Grain
                                       
                                       
                                      278
                                      278
                                97, 93 (95)[2]
                                    95, 98
                                   100, 103
[1] Two concurrent recovery samples were analyzed with the samples stored for 244 days.  The recoveries were 76% for the sample spiked at 0.05 ppm and 104% for the sample spiked at 0.501 ppm.  Since there is a large body of data indicating that residues of novaluron are typically stable during freezer storage, it was determined that the concurrent recovery value of 76% could be used to correct the recoveries of the stored samples.   
[2] Two concurrent procedural recovery samples (spiked at 0.5 ppm) were analyzed with the 277-day storage stability samples.  The average concurrent recovery values were used to correct the recoveries of the stored samples.

Conclusions:  Concurrent storage stability data were submitted for avocado, carrot, cucumber, and lima bean.  These data demonstrate that residues of novaluron were stable for the durations for which the field trial samples were frozen.  Although the corrected recoveries for cucumber were >120%, since storage stability data are available which demonstrate that fortified residues of novaluron are relatively stable under frozen conditions for a wide variety of crops, additional cucumber storage stability data are not required.  Acceptable storage stability data for dried plum and sorghum forage and grain that demonstrate that residues of novaluron were stable in these commodities for the duration that the field trial samples were stored have been submitted to the Agency; therefore, these deficiencies are now resolved.  Revised grain sorghum tolerances are not required based on the submitted sorghum forage and grain storage stability data.  The submitted storage stability data for dried plum do not impact the established tolerance; however, a revised tolerance is being recommended for dried plum in order to harmonize with Codex.

860.1480 Meat, Milk, Poultry, and Eggs

Livestock dietary burdens

Residue Chemistry Memo, DP# 285474, 22-MAR-2004, G. Kramer (PP#2F6430)
Residue Chemistry Memo, DP# 315890, 10-MAY-2005, G. Kramer (PP#2F6430)
Residue Chemistry Memo, DP# 336897, 31-JAN-2008, S. Levy (PP#2F06430)
Residue Chemistry Memo, DP# 340137, 7-FEB-2008, G. Kramer (PP# 7E7199) 
Residue Chemistry Memo, DP#s 378631 and 378635, 15-SEP-2011, J. Van Alstine (PP#s 0E7723 and 0F7708)

The potential for secondary transfer of novaluron residues of concern in meat, milk, and eggs exists because there are livestock feedstuffs associated with the registered uses of novaluron.  Carrot culls, a carbohydrate concentrate, are the only livestock feed item associated with the current petition.  Carrot culls may be fed to dairy cattle, but are not fed to beef cattle, poultry, or swine.  The most recently updated livestock dietary burden includes grain sorghum grain and apple wet pomace as carbohydrate concentrate feed items for dairy cattle (Memo, J. Van Alstine, 15-SEP-2011; D378631).  The incorporation of carrot culls into the dairy cattle livestock diet will not result in higher livestock dietary burdens; therefore, revised livestock dietary burdens are not required at this time.  No changes are necessary for the tolerances for secondary residues of novaluron in/on cattle, goat, horse, sheep, poultry, and swine commodities.  

860.1500 Crop Field Trials

Avocado

DER Reference:  49303201.der.docx

Six field trials were conducted in the United States during the 2009 and 2010 growing seasons.  Trials were conducted in North American Free Trade Agreement (NAFTA) Growing Zones 10 (CA, 4 trials) and 3 (FL, 2 trials).

Each trial site consisted of one untreated plot and one treated plot.  At each trial location, three foliar applications of the test substance (Rimon(R) 0.83 EC) were made 13-15 days apart to the treated plots, at rates of 0.118-0.127 lb ai/A per application for a total rate of 0.364-0.378 lb ai/A per season.  Applications were made in a spray volume of 95-116 gal/A, and included a non-ionic surfactant in the spray mixture.  Avocado RAC samples were harvested one day after the last application.  A residue-decline study was conducted at the CA48 trial where duplicate samples were collected on the day of the last application and 4, 8, and 10 days after the last application.  The number and geographical distribution of the supervised crop field trials on avocado are adequate.  Three of the field trials were conducted at the same location in 2009 in Irvine, CA.  Although these trials were in the same location, the initial application dates (26-MAR-2009, 12-MAY-2009, 24-JUN-2009) are more than 30 days apart, so the trials can be considered independent.

Novaluron residues in/on avocado ranged from 0.125 ppm to 0.327 ppm in samples taken one day after the last application.  In the residue-decline trial, samples taken at intervals from 0-10 days after the last application did not show a consistent decline in residues.
  
Table 7.  Summary of Residue Data from Crop Field Trials with Novaluron.
                                Commodity (RAC)
                         Total Applic. Rate (lb ai/A)
                                  PHI (days)
                       Novaluron Residue Levels (ppm)[1]

                                       n
                                     Min.
                                     Max.
                                     LAFT
                                     HAFT
                                    Median
                                     Mean
                                   Std. Dev.
                           Avocado fruit without pit
                                  0.364-0.378
                                       1
                                       6
                                     0.125
                                     0.327
                                    0.1305
                                     0.280
                                     0.185
                                     0.192
                                     0.055
[1] LAFT = lowest average field trial; HAFT = highest average field trial.  Except for sample min/max, values reflect per-trial averages; n = no. of field trials.

Conclusions:  The field trial data reflect the proposed use rate and PHI for avocado.  The number and locations of field trials are in accordance with OCSPP Guideline 860.1500.  Although three of the trials were in the same location in 2009, the initial application dates are more than 30 days apart, so the trials can be considered independent.  The field trial data for avocado were entered into the OECD tolerance calculator to determine the appropriate tolerance level (see Appendix III).  The available data support a tolerance of 0.60 ppm for residues of novaluron in/on avocado.  
 
Carrot

DER Reference:  49303202.der.docx

Eight field trials were conducted in the United States during the 2009 and 2010 growing seasons.  Trials were conducted in NAFTA Growing Zones 10 (CA, 4 trials), 2 (GA, 1 trial), 5 (OH, 1 trial), 6 (TX, 1 trial), and 11 (WA, 1 trial).

Each trial site consisted of one untreated plot and one treated plot.  At each test location, three foliar broadcast or directed applications of the test substance (Rimon(R) 0.83 EC) were made 6-9 days apart to the treated plots at rates of 0.078-0.083 lb ai/A per application for a total rate of 0.235-0.245 lb ai/A per season.  Applications were made in a spray volume of 24-58 gal/A, and included a non-ionic surfactant in the spray mixture.  Carrot RAC samples were harvested 2-4 days and 6-8 days after the last application.  In the GA*07 trial, samples were collected only at 8 days after the last application.  The number and geographical distribution of the supervised crop field trials on carrot satisfy the OCSPP 860.1500 data requirements.  Two of the field trials were conducted in Salinas, CA in 2009.  Although these trials were <20 miles apart, they are considered separate trials since the planting and initial application dates are more than 30 days apart (the CA*55 carrots were planted on 28-MAY-2009, with applications starting on 18-JUL-2009 and the CA*54 carrots were planted on 05-AUG-2009, with applications starting on 07-OCT-2009).  It is noted that the GA*7 field trial was conducted in Tifton, GA which is located in NAFTA Growing Zone 2, but is near the border of NAFTA Growing Zone 3.

The results from these trials showed that novaluron residues in/on carrot were <0.050 ppm in/on all carrot samples harvested 2-4 days or 6-8 days after the last application of novaluron at the rate of 0.078-0.083 lb ai/A per application.  A PHI proposed in the label is 3 days.  No residue-decline studies were submitted. 
  
Table 8.  Summary of Residue Data from Crop Field Trials with Novaluron.
                                   Commodity
                         Total Applic. Rate (lb ai/A)
                                  PHI (days)
                            Residue Levels (ppm)[1]
                                       
                                       
                                       
                                       n
                                     Min.
                                     Max.
                                     LAFT
                                     HAFT
                                    Median
                                     Mean
                                   Std. Dev.
                                    Carrot
                                  0.235-0.245
                                      2-4
                                     7[2]
                                   <0.050
                                   <0.050
                                   <0.050
                                   <0.050
                                   <0.050
                                   <0.050
                                       -
                                       
                                       
                                      6-8
                                       8
                                   <0.050
                                   <0.050
                                   <0.050
                                   <0.050
                                   <0.050
                                   <0.050
                                       -
[1] LAFT = lowest average field trial; HAFT = highest average field trial; n = no. of field trials.
[2] In the GA*07 trial, samples were collected only at 8 days after the last application.  

Conclusions:  The field trial data reflect the proposed use rate and PHI for carrot.  The number and locations of field trials are in accordance with OCSPP Guideline 860.1500.  Although two of the trials were in the same location in 2009, the initial application planting and application dates are more than 30 days apart, so the trials can be considered independent.  Additionally, although a field trial was not conducted in NAFTA Growing Zone 3, as recommended, a trial is available for carrots grown in NAFTA Growing Zone 2 near the border of Zone 3, so an additional trial is not needed.  Since all residues of novaluron in/on carrot were less than the LLMV (0.05 ppm), the recommended tolerance for carrot is 0.05 ppm.  

Cucumber

DER Reference:  49303204.der.docx

Four greenhouse trials were conducted in the United States and Canada during the 2009 and 2010 growing seasons.  Trials were conducted in NAFTA Growing Zones 5 (BC, 1 trial), 6 (CO, 1 trial), 9 (TX, 1 trial), and 12 (ON, 1 trial).

Each greenhouse trial site consisted of one untreated plot and one treated plot.  At each trial location, three foliar applications of the test substance Pedestal (Rimon(R) 10 EC with a nominal concentration of 0.83 lb ai/gal) were made 13-15 days apart to the treated plots at rates of 0.079-0.085 lb ai/A per application for a total rate range of 0.241-0.250 lb ai/A per season.  Applications were made in a spray volume of 35-43 gal/A, and included a non-ionic surfactant in the spray mixture.  Cucumber RAC samples were harvested on the day of the last application, after the spray had dried.  A residue-decline study was conducted at the ON12 trial where additional duplicate samples were collected 1, 3, 6, and 8 days after the last application.  The number of the supervised crop field trials on cucumber is adequate.

Novaluron residues in/on cucumber were in the range <0.050 (LOQ) to 0.0677 ppm in samples collected on the day of the last application.  In the residue-decline trial, samples taken at intervals from 0 to 8 days after the last application showed comparable residues. 

Table 9.  Summary of Residue Data from Greenhouse Cucumber Trials with Novaluron.
                                   Commodity
                         Total Applic. Rate (lb ai/A)
                                      PHI
                                    (days)
                       Novaluron Residue Levels (ppm)[1]
                                       
                                       
                                       
                                       n
                                     Min.
                                     Max.
                                     LAFT
                                     HAFT
                                    Median
                                    Mean[2]
                                   Std. Dev.
                           Greenhouse-Grown Cucumber
                                  0.241-0.250
                                       0
                                       4
                                   <0.050
                                    0.0677
                                   <0.050
                                    0.0666
                                     0.050
                                    0.0542
                                    0.0083
[1] LAFT = lowest average field trial; HAFT = highest average field trial.  Except for sample min/max, values reflect per-trial averages; n = no. of field trials.  The calculations use a value of 0.050 ppm for residues <0.050 ppm.  

Conclusions:  The field trial data reflect the proposed use rate and PHI for greenhouse-grown cucumbers.  The proposed use pattern for greenhouse-grown cucumbers is the same as the registered use pattern for cucurbits (Memo, J. Van Alstine, 04-DEC-2009; D364237).  The number of field trials is in accordance with OCSPP Guideline 860.1500.  The field trial data for greenhouse-grown cucumbers were entered into the OECD tolerance calculator to determine the appropriate tolerance level (see Appendix III).  The available data support a tolerance of 0.15 ppm for residues of novaluron in/on greenhouse-grown cucumber.  A tolerance is currently established for residues of novaluron in/on vegetable, cucurbit, group 9 at 0.15 ppm.  The established Codex tolerance for fruiting vegetable cucurbits is 0.2 ppm; therefore, HED is recommending that the tolerance be revised to 0.20 ppm in order to harmonize with Codex.

Lima Beans

DER Reference:  49303203.der.docx

Five trials were conducted in the United States NAFTA Growing Zones 10 (CA, 1 trial), 2 (MD and NC, 2 trials), 5 (OH, 1 trial), and 11 (ID, 1 trial) during the 2009 growing season.  It is noted that MD11 and MD12 trials have the same sprayer nozzle, plant date, and application dates.  Although the varieties are different, it is not immediately apparent that independent tank mixes were made for each trial; therefore, the trials are not considered independent (the above field trial distribution considers this conclusion).

Each trial site consisted of one untreated plot and one treated plot.  At each trial location, three foliar broadcast or directed applications of the test substance (Rimon(R) 0.83 EC) were made 6-8 days apart to the treated plots at rates of 0.088-0.099 lb ai/A per application for a total rate of 0.267-0.283 lb ai/A per season.  Applications were made in a spray volume of 30-50 gal/A, and included a non-ionic surfactant in the spray mixture.  Lima bean RAC samples were harvested 2-4 days after the last application.  

Novaluron residues in/on lima bean were <0.050 ppm in/on all lima bean  samples harvested 2-4 days after the last application of novaluron at the rate of 0.088-0.095 lb ai/A per application, except for one treated sample from ID08 trial, which had a residue of 0.0523 ppm.  No residue-decline studies were submitted. 
  
Table 10.  Summary of Residue Data from Crop Field Trials with Novaluron.
                                   Commodity
                              Total Applic. Rate
                                   (lb ai/A)
                                  PHI (days)
                                       
                       Novaluron Residue Levels (ppm)[1]

                                       n
                                     Min.
                                     Max.
                                     LAFT
                                     HAFT
                                    Median
                                    Mean[2]
                                   Std. Dev.
Lima Bean
                                  0.267-0.283
                                      2-4
                                       5
                                   <0.05
                                    0.0523
                                   <0.05
                                    0.05115
                                     0.05
                                    0.0502
                                    0.0005
[1] LAFT = lowest average field trial; HAFT = highest average field trial.  Except for sample min/max, values reflect per-trial averages; n = no. of field trials.  The calculations use a value of 0.050 ppm for residues <0.050 ppm.  

Conclusions:  The proposed use pattern for lima beans is the same as the registered use pattern for snap and dry beans.  The field trial data reflect the proposed use rate for beans, but not the proposed 1-day PHI.  Although residue decline data were not submitted for lima beans, residue decline data are available for snap beans that indicate that residues of novaluron generally stayed the same with increasing PHIs for snap bean pods with seeds and snap bean foliage without pods.  Given that the use patterns are the same and that residues remained stable in the snap beans with increasing PHIs, the 2-4 day PHI lima bean data are acceptable for this petition.  

A total of 12 field trials (6 edible-podded bean field trials and 6 succulent-shelled bean field trials) are required to establish a tolerance for residues in succulent beans (OCSPP Guideline 860.1500).  HED previously reviewed data for 14 snap bean field trials and a tolerance was established for residues of novaluron in/on bean, snap, succulent at 0.60 ppm (Memo, J. Van Alstine, 04-DEC-2009; D364237).  There is sufficient data to recommend for a tolerance for residues of novaluron in/on beans, succulent based on the available snap bean and lima bean data.  Although only five independent lima bean field trials were submitted, an additional field trial is not being required since HED does not expect that the submission of an additional lima bean field trial would result in a higher recommended tolerance for residues of novaluron in/on succulent beans.  

The field trial data for lima beans were entered into the OECD tolerance calculator to determine the appropriate tolerance level (see Appendix III).  The available data support a tolerance of 0.07 ppm for residues of novaluron in/on lima beans.  A tolerance is currently established for residues of novaluron in/on bean, snap, succulent at 0.60 ppm.  The established Codex tolerance for common beans (pods and/or immature seeds) is 0.7 ppm; therefore, HED is recommending for the establishment of a tolerance value of 0.70 ppm for residues of novaluron in/on beans, succulent in order to harmonize with Codex.  This recommendation will not impact the tolerance established for residues in/on dry beans.  Additionally, the tolerance for residues in/on bean, snap, succulent should be deleted.  

Vegetable, fruiting, group 8-10

No new fruiting vegetable crop field trial data were submitted.  Tolerances for residues of novaluron in/on vegetable, fruiting, group 8, cocona, African eggplant, pea eggplant, scarlet eggplant, goji berry, garden huckleberry, martynia, naranjilla, okra, roselle, sunberry, bush tomato, currant tomato, and tree tomato have been established at 1.0 ppm [40 CFR §180.598(a)].  IR-4 has proposed to convert the established tolerances to a crop group 8-10 tolerance at the same level.  Field trial data are available for tomatoes, bell peppers, and non-bell peppers (Memo, G. Kramer, 7-FEB-2008, D340137; Memo, J. Van Alstine, 04-DEC-2009, D364237). The 1.0 ppm tolerance was derived based on greenhouse-grown tomato data (Memo, G. Kramer, 07-FEB-2008, D340137).  The memo states, in part, "The recommended tolerance is 0.45 ppm for field-grown tomatoes and 1.0 ppm for greenhouse-grown tomatoes; therefore, the higher tolerance of 1.0 ppm is recommended for novaluron on tomato."   

As the proposed use on vegetable, fruiting, group 8-10 is identical to the existing uses on vegetable, fruiting, group 8, cocona, African eggplant, pea eggplant, scarlet eggplant, goji berry, garden huckleberry, martynia, naranjilla, okra, roselle, sunberry, bush tomato, currant tomato, and tree tomato on the product label for Rimon[(R)] 0.83 EC Insecticide (0.83 lb/gal EC; EPA Reg. No. 66222-35), the existing tolerances can be translated to vegetable, fruiting, group 8-10.  Tolerances for residues of novaluron in/on fruiting vegetables other than cucurbits (except sweet corn) are established by Codex at 0.7 ppm.  Additionally, Canada has established tolerances for residues of novaluron in/on bell peppers at 0.8 ppm and non-bell peppers at 0.9 ppm.  HED does not recommend to lower the tolerances for vegetable, fruiting, group 8-10 to harmonize with Codex and Canada since the current U.S. tolerance is based on greenhouse-grown tomato data that support a tolerance value of 1.0 ppm.  

Pome fruit group 11-10

No new pome fruit field trial data were submitted.  A tolerance for residues of novaluron in/on pome fruit group has been established at 2.0 ppm [40 CFR §180.598(a)].  IR-4 has proposed to convert the pome fruit tolerance to a crop group 11-10 tolerance at the same level.  The representative commodities of the pome fruit group 11-10 are apple and pear.  Field trial data are available for apple and pear (Memo, S. Levy, 03-NOV-2005; D322978).  

As the proposed uses on pears (group 11-10) and pome fruit group 11-10, except pears are identical to the existing uses on pome fruit on the product label for Rimon[(R)] 0.83 EC Insecticide (0.83 lb/gal EC; EPA Reg. No. 66222-35), the existing pome fruit group tolerance can be translated to fruit, pome, group 11-10.  However, in order to harmonize with Codex, HED recommends that the U.S. tolerance be increased from 2.0 to 3.0 ppm.  

Cherry subgroup 12-12A, Peach subgroup 12-12B, and Plum subgroup 12-12C

No new stone fruit field trial data were submitted.  The following tolerances for residues of novaluron in/on stone fruit have been established:  cherry at 8.0 ppm; fruit, stone, group 12, except cherry at 1.9 ppm; and plum, prune, dried at 2.6 ppm [40 CFR §180.598(a)].  IR-4 has proposed to convert these established tolerances to cherry subgroup 12-12A, peach subgroup 12-12B, and plum subgroup 12-12C tolerances at the same level.  A proposal was not made to change the plum, prune, dried tolerance.  The representative commodities of the stone fruit group 12-12 are sweet cherry or tart cherry, peach, and plum or prune plum.  Field trial data are available for cherry, peach, and plum (Memo, J. Van Alstine, 09-SEP-2009; D357060).  

As the proposed uses on cherry subgroup 12-12A, peach subgroup 12-12B, and plum subgroup 12-12C are identical to the existing use on stone fruit on the product label for Rimon[(R)] 0.83 EC Insecticide (0.83 lb/gal EC; EPA Reg. No. 66222-35), the existing tolerances for stone fruit can be translated to cherry subgroup 12-12A (8.0 ppm), peach subgroup 12-12B (1.9 ppm), and plum subgroup 12-12C (1.9 ppm).  The stone fruit tolerances are harmonized with Canada (8.0 ppm for cherry, 1.9 ppm for fruit, stone, group 12, except cherry, and 2.6 ppm for plum, prune, dried); however they are not harmonized with Codex (7 ppm for stone fruit and 3 ppm for prunes).  HED recommends for harmonization of the plum, prune, dried tolerance with Codex (3.0 ppm).  

860.1520 Processed Food and Feed

There are no processed commodities associated with avocado, carrot, cucumber, and lima bean.  Although there are processed commodities associated with fruiting vegetables, pome fruit, and stone fruit, processing studies were not required since the petitioner has requested updates to the crop group commodity definitions which are supported with previously submitted data, including processing studies.

860.1650 Submittal of Analytical Reference Standards

An analytical standard for novaluron is currently available in the National Pesticide Standards Repository (electronic communication from T. Cole to J. Van Alstine, 29-JAN-2015).  However, the standard has an expiration date of 07-MAR-2015.  A new reference standard should be sent to the Analytical Chemistry Lab, which is located at Fort Meade, to the attention of either Theresa Cole or Thuy Nygen at the following address:

	USEPA
	National Pesticide Standards Repository/Analytical Chemistry Branch/OPP
	701 Mapes Road
	Fort George G. Meade, MD  20755-5350

(Note that the mail will be returned if the extended zip code is not used.)

860.1850 and 860.1900 Confined and Field Accumulation in Rotational Crops

The carrot, cucumber, and bean commodities associated with the current petitions may be rotated.  Avocados, pome fruit, and stone fruit are not 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 0.4X the maximum proposed seasonal application rates [0.239 lb ai/A (carrot), 0.234 lb ai/A (cucumber), 0.234 lb ai/A (beans)] for carrot, cucumber, and bean commodities.  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.  Future uses that have significantly higher application rates will require confined rotational crop studies at higher rates using chlorophenyl-labeled novaluron.  Based on the results of the confined rotational crop study, the appropriate PBI for all non-labeled crops is 30 days.  The current and proposed labels include 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 in rotational crops (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; D340137).  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 1.  A revised Section F is requested which reflects HED's recommended tolerances and commodity definitions presented in Table 1.  

No Canadian, Codex, or Mexican MRLs have been established for residues of novaluron in/on avocado and carrot.  Codex has established the following MRLs for residues of novaluron: 0.7 ppm common bean (pods and/or immature seeds); 0.7 ppm on fruiting vegetables other than cucurbits; 3 ppm in pome fruit; 3 ppm in prunes; 7 ppm in stone fruits; and 0.2 ppm in fruiting vegetables cucurbits.  Canada has established the following MRLs for residues of novaluron: 0.6 ppm in edible-podded snap beans; 0.8 ppm in bell peppers; 0.9 ppm in non-bell peppers; 2 ppm in apples, Asian pears, crabapples, loquats, mayhaws, pears, and quinces; 2.6 ppm in plum, prune, dried; 8 ppm in sweet and tart cherries; and 1.9 ppm in apricots, fresh prune plums, nectarines, peaches, plumcots, and plums.  HED is recommending to harmonize residues with Codex for the following commodities and crop groups: bean, succulent (0.70 ppm); vegetable, cucurbit, group 9 (0.20 ppm); fruit, pome, group 11-10 (3.0 ppm); and plum, prune, dried (3.0 ppm).  HED does not recommend to lower the tolerances for vegetable, fruiting, group 8-10 to harmonize with Codex and Canada since the current U.S. tolerance is based on greenhouse-grown tomato data that support a tolerance value of 1.0 ppm.  

The OECD tolerance calculation procedures were utilized for determining appropriate tolerance levels; see Appendix III for tolerance calculations.

ChemSAC Reference

This memorandum was reviewed by two members of the Chemistry Science Advisory Council (ChemSAC) and has been revised to reflect their recommendations.

References

MARC Decision Memo, DP# 297646, 2/3/04, G.F. Kramer 

DP#:		307595
Subject:	PP#2F6430.  Memo to FDA for Inclusion of the Novaluron Analytical Methods in 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

DP#:		D374420		
Subject:	Novaluron.  Petition for the Establishment of Permanent Tolerances for Residues of Novaluron in/on Grain Sorghum.  Summary of Analytical Chemistry and Residue Data.
From:	J. L. Van Alstine
To:	John Hebert (RM 07)/ Jennifer Gaines
Date:		02/23/2010

Appendices:  
Appendix I:  International Residue Limit Status sheet
Appendix II - Tolerance-Assessment Calculations

cc:  Julie L. Van Alstine (RAB1) 
RDI:  G. Kramer (20-MAR-2015), RAB1 Chemists (25-FEB-2015)
J.L.Van Alstine:S10951:PY-S:(703)603-8866:7509P:RAB1

Template Version September 2005
Appendix I:  International Residue Limit Status Sheet.
                        Novaluron (124002; 08-26-2014)
Summary of US and International Tolerances and Maximum Residue Limits. 
Residue Definition:
US
Canada
Mexico[2]
Codex[3]
40 CFR §180.598:
Plant and Livestock:  N-[[[3-chloro-4-[1,1,2-trifluoro-2- (trifluoromethoxy)ethoxy]phenyl]amino]carbonyl]-2,6-difluorobenzamide

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

Novaluron (fat soluble)
Commodity
Tolerance (ppm) /Maximum Residue Limit (mg/kg)

                                      US
Canada
Mexico[2]
Codex[3]
Avocado
0.60

Carrot
0.05

Bean, succulent
0.70

0.1 beans (dry)
0.7 common bean (pods and/or immature seeds)
0.01 (*) soybean (immature seeds)
Vegetable, fruiting, group 8-10
1.0
0.8 bell peppers

0.9 non-bell peppers

0.7 fruiting vegetables other than cucurbits
Fruit, pome, group 11-10
3.0
2 apples, Asian pears,  crabapples, loquats, mayhaws,  pears, quinces

3
Cherry subgroup 12-12A
8.0
8 sweet cherries, tart cherries

7 stone fruits

Peach subgroup 12-12B
1.9
1.9 nectarines, peaches

Plum subgroup 12-12C
1.9
1.9 apricots, fresh prune plums, plumcots, plums

7 stone fruits
3 prunes
Plum, prune, dried
3.0
2.6

3 prunes
Completed by: M. Negussie; 09/08/14
Appendix II.  Dried Plum and Sorghum Forage and Grain Storage Stability Data

HED previously requested storage stability data on dried plums for up to 243 days (Memo, J. Van Alstine, 09-SEP-2009; D357078) and on grain sorghum forage, grain, AGF, and stover for up to 275, 253, 237, and 245 days, respectively (Memo, J. Van Alstine, 23-FEB-2010; D364307).  Acceptable storage stability data for these commodities have been submitted to the Agency and these deficiencies are now resolved (dried plum MRID 48482701; sorghum MRID 48156601).  The results are summarized below.  

Dried plums were purchased and placed in the freezer.  The frozen dried plums were processed by chopping with dry ice.  The samples were returned to the freezer to allow the ice to sublimate.  Subsamples (10 g) were then taken and placed into Mason jars.  The subsamples were fortified with novaluron at approximately 0.5 ppm on 20-APR-2010, 13-MAY-2010, and 27-MAY-2010.  The samples were analyzed using a method that is similar to the reference method, "Magnitude of the Residue on Novaluron in Pome Fruit Raw Agricultural and Processed Commodities."  The calculated LOD was 0.028 ppm and the calculated LOQ was 0.084 ppm.  The fortified dried plums were analyzed for novaluron recoveries after storage periods of 0 days, 125 days, and 244 days.  Concurrent recoveries were 115% at 0 days, 71% at 125 days, and 76 and 104% at 244 days.  Since there is a large body of data indicating that residues of novaluron are typically stable during freezer storage, it was determined that the concurrent recovery value of 76% could be used to correct the recoveries of the samples stored 244 days.  The corrected recoveries for the storage stability samples were in the ranges of 95-97% at 0 days, 115-148% at 125 days, and 68-105% at 244 days.  These data indicate that novaluron is stable under the frozen storage conditions for up to 125 days, and then decline (but can still be recovered) when stored up to 244 days.  The dried plum storage stability deficiency has been resolved.  

Table A.2.1.  Summary of Recoveries of Novaluron from Dried Plum.
                                    Matrix
                                  Spike Level
                                     (ppm)
                                  Sample Size
                                      (n)
                                  Recoveries
                                      (%)
                                Mean +- std dev
                                      (%)
                               Method Validation
                                  Dried Plum
                                     0.050
                                       6
                           86, 86, 82, 72, 112, 120
                                   93 +- 19
                                       
                                     0.50
                                       3
                                  100, 95, 99
                                    98 +- 3
                                       
                                     1.00
                                       3
                                  85, 91, 82
                                    86 +- 5
                                       
                                    Overall
                                      12
                                      --
                                   93 +- 14
                     Storage Stability Concurrent Recovery
                                  Dried Plum
                                     0.050
                                       1
                                      76
                                      --
                                       
                                      0.5
                                       3
                                 115, 71, 104
                                   97 +- 23
                                       
                                    Overall
                                       4
                                      --
                                   92 +- 22

Table A.2.2.  Summary of Storage Conditions for Dried Plum.
                                 Matrix (RAC)
                                    Analyte
                           Storage Temperature (°C)
                        Actual Storage Duration (days)
               Interval of Demonstrated Storage Stability (days)
                       Fresh Fortification Recovery (%)
                    Apparent Recovery in Stored Sample (%)
                    Corrected Recovery in Stored Sample (%)
                                  Dried Plum
                                   Novaluron
                                   -31 to -1
                                       0
                                       0
                                      115
                                 112, 108, 109
                                  97, 94, 95
                                       
                                       
                                       
                                      125
                                      125
                                      71
                                 82, 102, 105
                                 115, 144, 148
                                       
                                       
                                       
                                      244
                                      244
                                     76[1]
                                  80, 65, 52
                                  105, 86, 68
[1] Two concurrent recovery samples were analyzed with the samples stored for 244 days.  The recoveries were 76% for the sample spiked at 0.05 ppm and 104% for the sample spiked at 0.501 ppm.  Since there is a large body of data indicating that residues of novaluron are typically stable during freezer storage, it was determined that the concurrent recovery value of 76% could be used to correct the recoveries of the stored samples.   

The sorghum forage and grain samples were transferred from Study AA070701 (MRID 47727201).  The original sample identifications were maintained; however, additional designations such as "control," "fortified control," "procedural fortified control," or "stability fortified control" were added to identify the function of each sample.  The samples were analyzed using Makhteshim Chemical Works Ltd. analytical method from Study No. MAK/668, an HPLC/MS/MS method entitled, "Development and Validation of Methodology for the Post-Registration Monitoring of Residues of Novaluron in Apples and Potatoes."  The LOQ was 0.05 ppm.  The fortified sorghum forage and grain samples were analyzed for novaluron recoveries after storage periods of 0 days, 193/194 days, and 277/278 days.  Mean concurrent recoveries were 101 +- 9% for sorghum forage and 105 +- 8% for sorghum grain.  The corrected recoveries for the storage stability samples were in the ranges of 89-93% at 193 days and 103-108% at 277 days for sorghum forage and 89-90% at 194 days and 100-104% at 278 days for sorghum grain.  These data indicate that novaluron is stable under the frozen storage conditions for up 277 days in sorghum forage and grain.  HED requested data on grain sorghum forage, grain, AGF, and stover.  The submitted storage stability data on sorghum forage may be translated to stover and the sorghum grain data may be translated to AGF; therefore, the sorghum storage stability deficiencies are resolved.  

Table A.2.3.  Summary of Recoveries of Novaluron from Sorghum.
                                    Matrix
                                  Spike Level
                                     (ppm)
                                  Sample Size
                                      (n)
                                  Recoveries
                                      (%)
                                Mean +- std dev
                                      (%)
                       Concurrent Procedural Recoveries
                                Sorghum Forage
                                      0.5
                                       7
                        109, 100, 101, 108, 111, 90, 90
                                   101 +- 9
                                 Sorghum Grain
                                      0.5
                                       7
                        106, 103, 108, 115, 115, 97, 93
                                   105 +- 8

Table A.2.4.  Summary of Storage Conditions for Sorghum Forage and Grain.
                                 Matrix (RAC)
                                    Analyte
                           Storage Temperature (°C)
                        Actual Storage Duration (days)
               Interval of Demonstrated Storage Stability (days)
                 Fresh Fortification Recovery (%) (Average %)
                    Apparent Recovery in Stored Sample (%)
                  Corrected Recovery in Stored Sample (%)[1]
                                Sorghum Forage
                                   Novaluron
                                   -20 +- 5
                                       0
                                       0
                                      --
                               109, 100, 101[2]
                                     [--]
                                       
                                       
                                       
                                      193
                                      193
                                108, 111 (110)
                                    98, 102
                                    89, 93
                                       
                                       
                                       
                                      277
                                      277
                                  90, 90 (90)
                                    97, 93
                                   108, 103
                                 Sorghum Grain
                                       
                                       
                                       0
                                       0
                                      --
                               106, 103, 108[2]
                                     [--]
                                       
                                       
                                       
                                      194
                                      194
                                115, 115 (115)
                                   102, 103
                                    89, 90
                                       
                                       
                                       
                                      278
                                      278
                                  97, 93 (95)
                                    95, 98
                                   100, 103
[1] Two concurrent procedural recovery samples (spiked at 0.5 ppm) were analyzed with the 193- and 277-day storage stability samples.  The average concurrent recovery values were used to correct the recoveries of the stored samples (except for 0-day samples).
[2] Data for 0-day from method validation phase (0.5-ppm fortifications only) of Study AA070701.

Appendix III.  Tolerance-Assessment Calculations.

                                   Novaluron
                                    Avocado
                                      US
                                      GAP
 
 
Total number of data (n)
                                       6
Percentage of censored data
                                      0%
Number of non-censored data
                                       6
Lowest residue
                                     0.131
Highest residue
                                     0.280
Median residue
                                     0.185
Mean
                                     0.192
Standard deviation (SD)
                                     0.055
Correction factor for censoring (CF)
                                     1.000
 
                                       
Proposed MRL estimate
 
 
                                       
- Highest residue
                                     0.280
- Mean + 4 SD
                                     0.413
- CF x 3 Mean
                                     0.575
Unrounded MRL
                                     0.575
 
                                       
Rounded MRL
                                      0.6
 
                                       
 High uncertainty of MRL estimate.
[Small dataset]

                               Residues (mg/kg)
                                       n
                                    0.1305
                                       1
                                    0.1425
                                       1
                                    0.1825
                                       1
                                    0.1875
                                       1
                                    0.2265
                                       1
                                     0.28
                                       1

                                   Novaluron
                           Greenhouse-Grown Cucumber
                                      US
                                      GAP
 
 
Total number of data (n)
                                       4
Percentage of censored data
                                      50%
Number of non-censored data
                                       2
Lowest residue
                                     0.050
Highest residue
                                     0.067
Median residue
                                     0.050
Mean
                                     0.054
Standard deviation (SD)
                                     0.008
Correction factor for censoring (CF)
                                     0.667
 
                                       
Proposed MRL estimate
 
 
                                       
- Highest residue
                                     0.067
- Mean + 4 SD
                                     0.087
- CF x 3 Mean
                                     0.108
Unrounded MRL
                                     0.108
 
                                       
Rounded MRL
                                     0.15
 
                                       
 High uncertainty of MRL estimate.
[Small dataset]

                               Residues (mg/kg)
                                       n
                                   <0.05 
                                       2
                                    0.05005
                                       1
                                    0.0666
                                       1

                                   Novaluron
                                   Lima Bean
                                      US
                                      GAP
 
 
Total number of data (n)
                                       5
Percentage of censored data
                                      80%
Number of non-censored data
                                       1
Lowest residue
                                     0.050
Highest residue
                                     0.051
Median residue
                                     0.050
Mean
                                     0.050
Standard deviation (SD)
                                     0.001
Correction factor for censoring (CF)
                                     0.467
 
                                       
Proposed MRL estimate
 
 
                                       
- Highest residue
                                     0.051
- Mean + 4 SD
                                     0.052
- CF x 3 Mean
                                     0.070
Unrounded MRL
                                     0.070
 
                                       
Rounded MRL
                                     0.07
 
                                       
 High uncertainty of MRL estimate.
[Small dataset and high level of censoring]

                               Residues (mg/kg)
                                       n
                                   < .05 
                                       4
                                    0.05115
                                       1