                 UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
                         WASHINGTON, D.C. 20460

                                                 	OFFICE OF CHEMICAL SAFETY AND
                                                                                POLLUTION PREVENTION

MEMORANDUM

Date:		30-NOV-2011

SUBJECT:	Acequinocyl.  Petition for Use on Succulent Soybean Vegetable; Succulent Shelled Beans; Cowpea Forage; Caneberry Subgroup 13-07A; Melon Subgroup 9A; Cucumber, Cherry; Low-Growing Berry Subgroup 13-07G; and Small Fruit Vine Climbing, Except Fuzzy Kiwifruit, Subgroup 13-07F.  Summary of Analytical Chemistry and Residue Data.

PC Code:  006329
DP Barcode:  D389989
Decision No.:  448205
Registration No.:  66330-38
Petition No.:  1E7864
Regulatory Action:  Section 3
Risk Assessment Type:  NA
Case No.:  7621
TXR No.:  NA
CAS No.:  57960-19-7
MRID Nos.:  484629-01 thru -05
40 CFR:  §180.599

FROM:	Sarah J. Levy, Chemist
		Risk Assessment Branch 1 (RAB1)
		Health Effects Division (HED; 7509P)

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

TO:		Barbara Madden, RM Team 05
		Registration Division (RD; 7505P)

Executive Summary

Acequinocyl is a quinoline-type miticide registered for use in the U.S. on a number of raw agricultural commodities (RACs) for the control of various phytophagous mite species.  Acequinocyl is currently registered to Arysta Lifescience North America Corporation as a 15% suspension-concentrate (SC) formulation.  Note that the cucumber and caneberry field trial data were a joint-review with Canada.

Under PP#1E7864, the Interregional Research Project No.4 (IR-4), on behalf of the Agricultural Experiment Station of TX, CA, OR, PA, GA, NM, OK, TN, UT, MI, FL, and AZ, is requesting for the establishment of tolerances for combined residues of the insecticide acequinocyl, 2-(acetyloxy)-3-dodecyl-1,4-naphthalenedione, and its metabolite, 2-dodecyl-3-hydroxy-1,4-naphthoquinone (acequinocyl-OH), expressed as acequinocyl equivalents in/on the following commodities:

   Soybean, vegetable, succulent	0.25 ppm
   Low growing berry subgroup 13-07G	0.4 ppm
   Small fruit vine climbing subgroup 13-07F, except fuzzy kiwifruit	1.6 ppm
   Bean, succulent shelled	0.15 ppm
   Cowpea, forage	9.0 ppm
   Caneberry subgroup 13-07A	4.5 ppm
   Melon subgroup 9A	0.06 ppm
   Cucumber	0.15 ppm
   Cherry	0.8 ppm

No new data were submitted to support tolerances on succulent soybean vegetables, low-growing berry 13-07G crop subgroup, or small fruit vine climbing subgroup 13-07F, except fuzzy kiwifruit.  The petitioner has requested that existing tolerances be expanded to their respective crops or crop groups.

The end-use product proposed for use on the aforementioned proposed crops is Kanemite(TM) 15 SC Miticide, a 1.25 lb/gal soluble concentrate (SC) formulation (alternate brand names:  Shuttle(TM) 15 SC Miticide, and Shuttle(TM) O Miticide).  Up to two foliar, postemergence, ground applications are proposed for a maximum seasonal rate of 0.6 lb ai/A, with a 1-day preharvest interval (PHI), except for succulent shelled beans and cherries for which a 7-day PHI is proposed.

Tolerances are currently established under 40 CFR §180.599(a) for the combined residues of acequinocyl and its metabolite, 2-dodecyl-3-hydroxy-1,4-naphthoquinone, expressed as acequinocyl equivalents, in/on a number of plant and livestock commodities.  Tolerances for plant commodities range from 0.02 ppm (tree nuts and pistachios) to 30 ppm (citrus oil), and tolerances for livestock commodities are established at 0.02 ppm in the fat and liver of cattle, goat, horse, and sheep.

The nature of acequinocyl residues in apples, oranges, and eggplants is understood based on the previously reviewed metabolism studies.  In these crops, the metabolism of acequinocyl involves the loss of the acetyloxy moiety to form acequinocyl-OH, the opening of the quinone ring to form AKM-18, and the subsequent degradation of the quinone ring to yield polar metabolites that degrade to phthalic acid.  For purposes of risk assessment and the tolerance expression, HED has determined that the residues of concern in these commodities include parent and acequinocyl-OH (Memo, S. Levy, 07-JAN-2004; DP# 297872).  These data are considered sufficient for the currently requested crops.

There are adequate residue analytical methods for enforcing tolerances for acequinocyl residues of concern in/on the proposed/registered commodities.  These methods include two high-performance liquid chromatography methods with tandem mass-spectroscopy detection (HPLC/MS/MS) for determining residues in/on plant commodities (Morse Methods Meth-135 and #Meth-133, revision #3).  For each of these methods, residues are extracted with hexane or acetonitrile (ACN)/water and cleaned up by solvent partitioning, gel-permeation chromatography (GPC) and/or silica-gel solid-phase extraction (SPE).  In the current field trials, residues of acequinocyl and acequinocyl-OH were determined using a modified version of Morse Method #Meth-133, revision #3.  The method limit of quantitation (LOQ; based on the lowest level of method validation (LLMV)) for succulent shelled beans was 0.02 ppm for each analyte.  The LOQ (based on the LLMV) for cantaloupe was 0.015 ppm for acequinocyl and 0.01 ppm for acequinocyl-OH.  For cherries, cucumbers, and caneberries, the LOQ (based on the LLMV) was 0.01 for each analyte.  The method was adequately validated in conjunction with the analysis of field trial samples.

Based on the potential dietary exposure of livestock to acequinocyl residues from the current and proposed uses, the dietary burden was re-evaluated.  The re-evaluated dietary burden indicates that the currently established tolerance level of 0.02 ppm for residues in cattle, goat, horse, and sheep fat are appropriate.  The established 0.02-ppm residue level in cattle, goat, horse, and sheep liver is appropriate; however, the commodity definition should be changed to "meat byproducts" rather than "liver."  With the establishment of the cattle, goat, horse, and sheep tolerance in meat byproducts, RD should remove the tolerance (40 CFR §180.599) for liver.  Furthermore, the meat byproducts tolerance of 0.02 ppm is adequate to cover residues in the kidney of cattle, goats, horses, and sheep.  A revised Section F should be submitted.

The data requirements for multiresidue (MRM) methods are fulfilled.  Certain MRM protocols resulted in acceptable recoveries.  The MRM testing data have been forwarded to the U.S. Food and Drug Administration (FDA) for further evaluation (Memo, S. Levy, 18-FEB-2004; DP# 298917).

The submitted concurrent storage stability data for the subject crops are adequate to support the storage intervals and conditions incurred by the field trial studies.

IR-4 submitted adequate field trial data in support of the proposed uses on succulent shelled beans, caneberry, cantaloupe, cherry, and cucumber.  The field trials reflect the proposed use patterns and an adequate number of field trials were conducted in major crop growing regions.  The submitted field trial data reflect applications made without the use of a spray adjuvant.  A revised Section B should be submitted prohibiting the addition of adjuvants to the spray solution.  The Organization for Economic Co-operation and Development (OECD) maximum residue limit (MRL) Calculator was used to determine the appropriate tolerance levels.  The field trial data will support tolerances of:  0.30 ppm for residues in/on bean, succulent shelled; 6.0 ppm for residues in/on cowpea, forage; 18 ppm for residues in/on cowpea, hay; 4.0 ppm for residues in/on caneberry subgroup 13-07A; 0.15 ppm for residues in/on melon subgroup 9A; 1.0 ppm for residues in/on cherry, tart; 0.50 ppm for residues in/on cherry, sweet; and 0.15 ppm for residues in/on cucumber.  A revised Section F should be submitted.

No new data were submitted to support tolerances on succulent soybean vegetables, low-growing berry 13-07G crop subgroup, or small fruit climbing vine subgroup 13-07F, except fuzzy kiwifruit.  However, existing established tolerances in 40 CFR §180.599 should be extended to support these crop group tolerances.  HED recommends that that the tolerance for residues in/on edible-podded beans should be extended to soybean, vegetable, succulent; the tolerance for residues in/on strawberries should be extended to the low-growing berry 13-07G subgroup; and the tolerance for residues in/on grapes should be extended to small fruit vine climbing subgroup 13-07F, except fuzzy kiwifruit (See Table 10 for details).

There are no processed food/feed items associated with the proposed uses.  Therefore, data requirements for this guideline are not relevant to this tolerance petition.

The proposed uses under this petition include the following typically rotated crops:  succulent soybeans, berries (subgroup 13-07G), succulent shelled beans, cowpea forage, cucumbers, and melons (subgroup 9A).  An adequate confined rotational crop study was submitted and reviewed with a previous petition.  The available data support a 30-day plantback interval (PBI) for all non-labeled crops, which is reflected on the proposed label.

Regulatory Recommendations and Residue Chemistry Deficiencies

Pending submission of revised Sections B (see requirements under Directions for Use) and F (see requirements under Proposed Tolerances) there are no residue chemistry issues that would preclude granting a permanent registration for the requested uses of acequinocyl or establishment of tolerances for residues of acequinocyl and acequinocyl-OH as follows: "tolerances are established for residues of acequinocyl, 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 the sum of acequinocyl [2-(acetyloxy)-3-dodecyl-1,4-naphthalenedione] and its metabolite, 2-dodecyl-3-hydroxy-1,4-naphthoquinone, calculated as the stoichiometric equivalent of acequinocyl, in or on the commodity."

Soybean, vegetable, succulent .......................................................
0.25 ppm
Low growing berry subgroup 13-07G[1] ..............................................
0.50 ppm
Small fruit vine climbing subgroup 13-07F, except fuzzy kiwifruit[1] ...
1.6 ppm
Bean, succulent shelled.................................................................................
0.30 ppm
Cowpea, forage...........................................................................
6.0 ppm
Cowpea, hay.................................................................................
18 ppm
Caneberry subgroup 13-07A............................................................
4.0 ppm
Melon subgroup 9A........................................................................
0.15 ppm
Cucumber......................................................................................
0.15 ppm
Cherry, tart.................................................................................
1.0 ppm
Cherry, sweet..............................................................................
0.50 ppm
Meat byproducts of cattle, goat, horse and sheep[1] ...........................
0.02 ppm
[1]  Note to RD:  With the establishment of these tolerances, the following tolerances should be removed:  strawberry; grape; and liver of cattle, goat, horse, and sheep.

A human-health risk assessment is forthcoming (DP# 389519).

860.1200 Directions for Use
   * The submitted field trial data reflect applications made without the use of a spray adjuvant.  A revised Section B should be submitted incorporating an adjuvant - use restriction.

860.1550 Proposed Tolerances
   * A revised Section F is required to amend the tolerances as specified in Table 10, as well as the tolerance expression (see Conclusions section under Table 10 for details).

Background

The chemical structure and nomenclature of acequinocyl and its regulated metabolite are presented in Table 1, and the physicochemical properties of acequinocyl are presented in Table 2.

Table 1.  Nomenclature of Test Compound and Metabolites.
Compound
                               \s \* MERGEFORMAT
Common name
Acequinocyl
Company experimental names
TM-41301 or AKD-2023
IUPAC name
3-dodecyl-1,4-dihydro-1,4-dioxo-2-naphthyl acetate
CAS name
2-(acetyloxy)-3-dodecyl-1,4-naphthalenedione
CAS #
57960-19-7
End-use products/EP
Kanemite(TM) 15 SC (1.25 lb ai/gal; EPA Reg. No. 66330-38)
Compound
                               \s \* MERGEFORMAT
Common name
Acequinocyl-OH
Company experimental names
R1
IUPAC name
2-dodecyl-3-hydroxy-1,4-napthoquinone
CAS name
2-dodecyl-3-hydroxy-1,4-naphthalenedione
CAS #
57960-31-3

Table 2.  Physicochemical Properties.
Parameter
Value
Reference (MRID)
Melting point
59.6 C
45434906
pH
6.94
45434904
Density
1.13 g/cm[3]
45434904
Water solubility (20°C)
6.69 ug/L
45434906
Solvent solubility (mg/L at 20°C)
1,2-dichloroethane: >250
acetone: >250
ethyl acetate: >250
xylene: >250
methanol: 6.1
n-heptane: 36
n-octanol: 29.2
45434904
Vapor pressure at 25°C
1.69 x 10[-9] pascals
45434905
Dissociation constant (pKa)
no measurable pKa
45434905
Octanol/water partition coefficient Log(KOW)
>6.2
45434906
UV/visible absorption spectrum
(max, nm)
neutral pH: 242, 248, 262, 270, 335
acid pH: 242, 248, 265, 270, 330
basic pH: 232, 245, 255, 275, 362
45434905

860.1200 Directions for Use

The petitioner provided a draft label for Kanemite(TM) 15 SC Miticide (EPA Reg. No. 66330-38), a 1.25 lb/gal SC formulation of acequinocyl.  This acequinocyl formulation is currently registered for use on several fruit and nut crops, fruiting vegetables, okra, edible-podded beans, and hops.  The proposed uses are summarized below in Table 3.

Table 3.  Summary of Proposed Directions for Use of Acequinocyl.
Applic. Timing, Type, and Equip.
                                  Formulation
                                [EPA Reg. No.]
                                 Applic. Rate
                                   (lb ai/A)
                          Max. No. Applic. per Season
                          Max. Seasonal Applic. Rate
                                   (lb ai/A)
                                      PHI
                                    (days)
                       Use Directions and Limitations[1]
                            Bean, succulent shelled
Postemergence, foliar;
Ground only
                                1.25 lb/gal SC
                                  [66330-38]
                                      0.3
                                       2
                                      0.6
                                       7
Minimum spray volume of 30 gal/A; minimum RTI of 14 days.  Do not allow grazing on cowpea forage within 7 days of last treatment.
                           Caneberry subgroup 13-07A
Postemergence, foliar;
Ground only
                                1.25 lb/gal SC
                                  [66330-38]
                                      0.3
                                       2
                                      0.6
                                       1
Minimum spray volume of 50 gal/A; minimum RTI of 21 days.
                               Melon subgroup 9A
Postemergence, foliar;
Ground only
                                1.25 lb/gal SC
                                  [66330-38]
                                      0.3
                                       2
                                      0.6
                                       1
Minimum spray volume of 30 gal/A; minimum RTI of 21 days.
                                   Cucumber
Postemergence, foliar;
Ground only
                                1.25 lb/gal SC
                                  [66330-38]
                                      0.3
                                       2
                                      0.6
                                       1
Minimum spray volume of 100 gal/A; minimum RTI of 21 days.  The use of an adjuvant or surfactant is prohibited.
                                    Cherry
Postemergence, foliar;
Ground only
                                1.25 lb/gal SC
                                  [66330-38]
                                      0.3
                                       2
                                      0.6
                                       7
Minimum spray volume of 40 gal/A; for optimal control, use a minimum of 150 gal/A; minimum RTI of 14 days.  Do not use in alternate row middle applications.
[1]  RTI = retreatment interval.

General label restrictions include:  (i) do not apply through any type of irrigation system; (ii) do not apply by air; (iii) do not apply within 75 feet of aquatic areas; and (iv) not for indoor residential use.  The product may be combined with most commonly used pesticides with the exception of strongly alkaline material, which can reduce activity; combination with Phos-ethyl (fosetyl) is prohibited.  Broad-spectrum insect control may be obtained by tank-mixing the SC acequinocyl product with other miticide/insecticide products; a spray mix compatibility and phytotoxicity trial under local conditions should first be conducted.

Rotational crop restrictions are as follows:  food and feed crops not listed on the proposed label must not be planted within 30 days of the last Kanemite(TM) 15 SC application.

Conclusions:  The proposed use directions are adequate to allow for evaluation of the submitted residue data relative to the proposed uses.  The proposed uses are supported by the submitted field trial data.

Furthermore, the submitted field trial data reflect applications made without the use of a spray adjuvant.  A revised Section B should be submitted incorporating an adjuvant - use restriction.

An adequate confined rotational crop study was previously submitted, reflecting the maximum proposed use pattern for rotated crops.  The available data support a 30-day PBI for all non-labeled crops, which is reflected on the proposed label.

860.1300 Nature of the Residue  -  Plants/Livestock

The qualitative nature of acequinocyl residues in fruit and nut crops is understood based on the available apple, orange, and eggplant metabolism studies (Memo, S. Levy, 10-MAR-2004; DP# 284757).  Residues in/on both the fruit and foliage were characterized in these metabolism studies.  The data indicate that the metabolism of acequinocyl in these crops involves the loss of the acetyloxy moiety to form acequinocyl-OH, opening of the quinone ring to form AKM-18, and subsequent degradation of the quinone ring to yield polar metabolites that degrade to phthalic acid.

Based on the structural similarity of acequinocyl-OH to parent and the presence of acequinocyl-OH at quantifiable levels in crops, the HED Metabolism Assessment Review Committee (MARC) concluded that parent and acequinocyl-OH are the residues of concern for risk assessment and tolerance expression in apples, oranges, and eggplant commodities (Memo, S. Levy, 07-JAN-2004; DP# 297872).  For purposes of this petition, HED is willing to translate these results to caneberries, cantaloupe, cherry, and cucumber as these are fruit crops and succulent shelled beans is a low-consumption food item.  However, if in the future, the petitioner requests new uses where apple, orange, and eggplant metabolism data cannot be translated, then HED may ask for additional plant metabolism data.

The qualitative nature of acequinocyl residues in ruminants is understood based on an adequate goat metabolism study (Memo, S. Levy, 10-MAR-2004; DP# 284757).  The metabolism of acequinocyl in goats appears to involve the loss of the acetyloxyl moiety to form acequinocyl-OH and partial cleavage of the dodecyl side chain to form AKM-15.  Opening and degradation of the quinone ring was also evidenced by the presence of AKM-18 and phthalic acid.  The MARC concluded that for tolerance expression, the residues of concern in livestock commodities include parent and acequinocyl-OH.  For risk assessment purposes, the residues of concern in livestock commodities are parent and acequinocyl-OH (for liver and kidney, metabolite AKM-15 is to be included as well (Memo, S. Levy, et al., 07-JAN-2004; DP# 297872).

Metabolism data on poultry are not required at the present time as none of the proposed or existing uses of acequinocyl are on crops having regulated poultry feedstuffs.

860.1340 Residue Analytical Methods

Enforcement methods:  Adequate analytical methods are available for enforcing acequinocyl tolerances in/on the proposed/registered plant commodities (Memo, D. Soderberg 23-MAY-2006; DP# 321753; Memo, S. Levy, 25-JUN-2008; DP#s 351336 & 353313).  These methods include two HPLC/MS/MS methods for determining acequinocyl and acequinocyl-OH residues in fruit crops (Morse Method #Meth-133, revision #3) and nut crops (Morse Method #Meth-135).  The three methods were forwarded by HED to Biological and Economical Analysis Division's (BEAD's) Analytical Chemistry Branch (ACB) for a petition method validation (PMV).  In lieu of a PMV, ACB completed a desk audit (Memo, P. Golden, 04-APR-2006; ACB# B04-13) in which ACB recommended that the petitioner revise methods # Meth-133, Revision #3 (including the modification for orange oil), # Meth-135, and # Meth-139 Revision #2 to address deficiencies.  The petitioner adequately addressed the modifications requested by ACB (Memo, P. Golden, 04-APR-2006; ACB# B04-13).  Methods #Meth-135, Revision #3, #Meth-133, Revision #4, and #Meth-139, Revision #3 are suitable enforcement methods for the subject crop and livestock matrices and no additional data concerning these methods are necessary (Memo, S. Levy, 25-AUG-2010; DP# 380302).

Data-gathering methods:  Samples of crop commodities that were collected from the magnitude of the residue studies were analyzed for residues of acequinocyl and acequinocyl-OH using modifications of the enforcement methods.  Samples from all submitted field trials were analyzed using a modified version of Method Meth-133.  A summary is given below.

Briefly, 10-g samples were extracted with ACN.  Extra water was added to insure that a minimum amount of water was available for adequate analyte extraction.  Following extraction, the water was salted out, and an aliquot of the resulting ACN phase was extracted with hexane to separate the analytes from the undesirable ACN-soluble co-extracted materials.  A final purification, incorporating silica SPE cartridge cleanup, was conducted.  The purified extract was concentrated and then submitted to HPLC/MS/MS analysis.

The LLMV for succulent shelled beans was 0.02 ppm for each analyte.  The LLMV for cantaloupe was 0.015 ppm for acequinocyl and 0.01 ppm for acequinocyl-OH.  For cherries, cucumbers, and caneberries, the LLMV was 0.01 for each analyte.

Conclusions:  An adequate HPLC/MS/MS method (Morse Method #Meth-133, revision #3) is available for enforcing the proposed tolerances, and the residue data from the field trials were determined using an adequate modification of this.  The method LOQ (based on the LLMV) for succulent shelled beans was 0.02 ppm for each analyte.  The LOQ (based on the LLMV) for cantaloupe was 0.015 ppm for acequinocyl and 0.01 ppm for acequinocyl-OH.  For cherries, cucumbers, and caneberries, the LOQ (based on the LLMV) was 0.01 for each analyte.

860.1360 Multiresidue Methods

Acceptable MRM method testing data were submitted for acequinocyl and acequinocyl-OH, and these data were forwarded to the U.S. FDA for further evaluation (Memo, S. Levy, 18-FEB-2004; DP# 298917).  Acequinocyl was adequately recovered from fortified apples using Method 302, E1 + C1 with GC/electron-capture detector (ECD), but was not recovered using Method 303 or 304 due to poor recoveries from the Florisil cleanup.  Acequinocyl-OH was completely recovered from fortified apples using Method 402, E1, or E2 + C1 with GC/ECD, but was not recovered using Methods 302, 303, or 304.

860.1380 Storage Stability

A summary of storage stability data are given below for each newly proposed crop.

Succulent beans
Samples of succulent bean seeds without pods were stored frozen for up to 824 days prior to analysis and 802 days for bean plants with pods.  The freezer storage stability of acequinocyl and acequinocyl-OH was assessed concurrently in this study, with samples spiked at 0.1 ppm.  Results from the concurrent storage stability study indicate that residues of acequinocyl and acequinocyl-OH are stable for up to 781 days in/on bean plants with pods (seed removed) and that residues of acequinocyl-OH are stable for up to 757 days in/on succulent bean seeds without pods and that acequinocyl residues decline ~50% during this interval in/on succulent bean seeds.  Residues were adjusted to account for the decline during storage.

Caneberry
Treated caneberry samples were stored frozen for up to 719 days prior to extraction.  All samples were analyzed within 1 day of extraction.  The freezer storage stability of acequinocyl and acequinocyl-OH residues in/on caneberries was assessed concurrently in this study, with samples spiked at 0.1 ppm.  The mean corrected residue recoveries (corrected for concurrent recoveries from freshly spiked samples) of acequinocyl and acequinocyl in samples stored frozen for 685 days were 84% (n=3, SD=5 %) and 80% (n=3, SD=3%), respectively.  As such, there are no concerns with the stability of acequinocyl and acequinocyl-OH over time in/on caneberry samples from this study.

Cantaloupe
Treated cantaloupe samples were stored frozen for up to 751 days prior to extraction.  Cantaloupe fruit storage stability samples were fortified with acequinocyl and acequinocyl-OH, each at 0.1 ppm.  Storage stability samples were analyzed 712 days after fortification.  Storage stability cantaloupe fruit samples averaged 66 +- 2% (n=3) for acequinocyl and 77 +- 3% (n=3) for acequinocyl-OH.  Concurrent storage stability recovery spikes averaged 98 +- 3% for acequinocyl and 84 +- 4% for acequinocyl-OH.  Results from the concurrent storage stability study indicate that residues of acequinocyl and acequinocyl-OH are stable for up to 712 days in/on cantaloupe and that acequinocyl residues decline to ~67% during this interval.  Residues were adjusted to account for the decline during storage.

Cherry
Treated cherry samples were stored frozen for up to 874 days (~29 months).  Results from the concurrent storage stability study indicate that residues of acequinocyl and acequinocyl-OH are stable for up to 874 days in/on cherries.  The mean corrected residue recoveries (corrected for concurrent recoveries from freshly spiked samples) of acequinocyl-OH in samples stored frozen for 874 days were 80% (n=3, SD=7).  There are no concerns with the stability of acequinocyl over time in/on cucumber samples from this study.

Cucumbers
Treated cucumber samples were stored frozen for up to 799 days prior to extraction.  The freezer storage stability of acequinocyl and acequinocyl-OH residues in/on cucumbers was assessed concurrently in this study, with samples spiked at 0.1 ppm.  The mean corrected residue recoveries (corrected for concurrent recoveries from freshly spiked samples) of acequinocyl and acequinocyl-OH in samples stored frozen for 741 days were 59% (n=3, SD=6 %) and 116% (n=3, SD=5%), respectively.  There are no concerns with the stability of acequinocyl-OH over time in/on cucumber samples from this study.  However, residues of acequinocyl in/on cucumbers declined significantly over a period of 741 days.  As such, residues of acequinocyl in/on treated cucumber samples were corrected for storage dissipation.

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

Table 4.  Summary of Storage Conditions and Durations of Samples from Crop Field Trial Studies.
Matrix
                                    Storage
                               Temperature (°C)
                                Actual Storage
                                   Duration
                  Interval of Demonstrated Storage Stability
Succulent bean seeds without pods
                                    <-20
                                   802 days
                                 (26.4 months)
Results from the concurrent storage stability study indicate that residues of acequinocyl-OH are stable for up to 757 days and that acequinocyl residues decline ~50% during this interval.
Succulent bean plants with pods

                                   824 days
                                 (26.4 months)
Results from the concurrent storage stability study indicate that residues of acequinocyl and acequinocyl-OH are stable for up to 781 days.
Caneberries
                                      -20
                                   719 days
                                 (23.6 months)
Results from the concurrent storage stability study indicate that residues of acequinocyl and acequinocyl-OH were stable for up to 685 days.
Cantaloupe
                                    <-20
                                    751days
                               (<=26.4 months)
Results from the concurrent storage stability study indicate that residues of acequinocyl-OH are stable for up to 712 days and that acequinocyl residues decline to ~67% during this interval.
Cherry
                                    <-20
                                   874 days
                               (<=28.7 months)
Results from the concurrent storage stability study conducted on cherries indicate that residues are stable for up to 874 days.
Cucumbers
                                      -20
                                      799
Corrected recoveries of acequinocyl residues from cucumbers stored frozen for up to 741 days ranged from 53 - 64% (mean +- SD = 59 +- 6%) indicating dissipation of residues.  Results from the concurrent storage stability study indicate that residues of acequinocyl-OH were stable for up to 741 days.

Conclusions:  The submitted concurrent storage stability data for the above-listed crops is adequate to support the storage intervals and conditions incurred by the field trial studies.

860.1480 Meat, Milk, Poultry, and Eggs

Based on the available goat and poultry metabolism data and the previously calculated dietary exposures of livestock to acequinocyl residues, HED previously set livestock commodities on cattle, goat, horse, and sheep fat and liver at 0.02 ppm (for more details, see:  S. Levy, 10-MAR-2004; D284757; and 05-SEP-2007; D330439).  Exposure of poultry and hog to acequinocyl is not expected, as there are no established or proposed tolerances on poultry or hog feedstuffs.  The maximum reasonable dietary burdens (MRDBs) of livestock to acequinocyl residues were previously calculated to be 0.72 ppm for beef cattle and 0.47 ppm for dairy cattle.

As cowpea forage and hay are significant feedstuff for livestock (dairy cattle only), the MRDB of acequinocyl was recalculated for this petition using the Agency's most recent guidance on constructing reasonably balanced livestock diets (Science Advisory Council for Chemistry (ChemSAC) memo, 30-JUN-2008).  The beef cattle MRDBs did not need to be recalculated as cowpea forage and hay are not beef feed items.  The recalculated MRDB for dairy cattle is 1.73 ppm (Table 5).

Table 5.  Calculation of Dietary Burdens of Acequinocyl Residues for Livestock.
Feedstuff
                               Dietary Component
                                % Dry Matter[1]
                                   % Diet[1]
                                   Residues
                                   (ppm)[2]
                         Dietary Contribution (ppm)[3]
Dairy Cattle
  Cowpea, forage
                                       R
                                      30
                                      20
                                     2.59
                                     1.73
  Apple, wet pomace
                                      CC
                                      40
                                      10
                                     0.01
                                    0.0025
TOTAL BURDEN
                                      100

                                     1.73
[1]	Potential dietary burdens for livestock were determined using recent Agency guidance on calculating reasonably balanced diets for livestock (memo, 30-JUN-2008).
[2]	The tolerance level for wet apple pomace was used and the HAFT was used for cowpea forage.
[3]	Contribution = ([tolerance (or HAFT)/% DM] X % diet) for dairy cattle.

Dairy cattle feeding study (previously reviewed: 45651610.de2)

In a ruminant feeding study, three groups of lactating dairy cows (4/group) were dosed orally twice a day for 28 consecutive days with gelatin capsules containing acequinocyl at target doses equivalent to 5, 15, and 50 ppm (5 DG, 15 DG, and 50 DG) in the feed on a dry weight basis.  Based on the average daily dietary intake, the actual dose levels were equivalent to 4.9, 14.9, and 48.6 ppm of acequinocyl in the diet.

The LOQ for combined acequinocyl residues is 0.02 ppm in milk and all tissues.  The limits of detection (LODs) for both analytes were not reported.  However, the LODs for each analyte have been estimated to be 0.001 ppm in milk, 0.002 ppm in muscle and fat, and 0.005 ppm in liver and kidneys.  With the exception of two fat samples, residues of acequinocyl were <LOD in all samples of milk and tissues from all three dose groups.  Acequinocyl residues above the LOD were found in samples of milk and tissues from each dose group, with the exceptions of kidney and muscle samples from the low dose group, which had residues <LOD.  In milk, the combined residues of acequinocyl and acequinocyl-OH (expressed in parent equivalents) were <0.002-0.003 ppm for the 5 ppm DG, <0.001-<0.005 ppm for the 15 ppm DG, and <0.003-0.013 ppm for the 50 ppm DG.  Residues appeared to plateau by Study Day 4.  Combined residues were <LOQ in all milk samples.  In liver, combined residues were <0.014-<0.032 ppm for the 5 ppm DG, <0.022-<0.037 ppm for the 15 ppm DG, and <0.059-<0.089 ppm for the 50 ppm DG.  In kidneys, combined residues were <0.01 ppm for the 5 ppm DG, <0.010-<0.014 ppm for the 15 ppm DG, and <0.019-<0.040 ppm for the 50 ppm DG.  In muscle, combined residues were <0.004 ppm for the 5 ppm DG, <0.004-<0.006 ppm for the 15 ppm DG, and <0.007-<0.008 ppm for the 50 ppm DG.  In fat, combined residues were <0.006-<0.013 ppm for the 5 ppm DG, <0.018-<0.030 ppm for the 15 ppm DG, and <0.044-<0.113 ppm for the 50 ppm DG.

For the 5, 15 and 50 DGs, the average combined residues were respectively <0.002, <0.003, and <0.006 ppm in milk; <0.023, <0.030, and <0.070 ppm in liver; <0.010, <0.012, and <0.034 ppm in kidneys; <0.004, <0.005, and <0.007 ppm in muscle; and <0.009, <0.022, and <0.075 ppm fat.  The combined acequinocyl residues increased linearly with increased feeding level in liver and fat, but there was no linear relationship between feeding level and residues in the other tissues and milk.

Considering only the LOQ (0.01 ppm) for the two analytes, the combined residues were <LOQ (<0.02 ppm) in milk and muscle samples from all three dose groups, the kidney samples from the 5 and 15 ppm DG and fat samples from the 5 DG.  Residues above the combined LOQ were found in liver at all three dose groups, fat samples from the 15 and 50 DG, and in kidney from the 50 ppm DG.

Table 6.	 Summary of Milk and Tissue Residue Data from Ruminant Feeding Study with Acequinocyl.
Matrix
                              Feeding Level (ppm)
                                 Study Days[1]
                 Combined Acequinocyl Residue Levels (ppm)[2]

                                       n
                                     Min.
                                     Max.
                                     Mean
                                   Std. Dev.
Milk
                                       5
                           4, 8, 12, 16, 20, 24, 28
                                      28
                                   <0.002
                                   <0.003
                                   <0.002
                                    0.0003

                                      15
                           4, 8, 12, 16, 20, 24, 28
                                      28
                                   <0.002
                                   <0.005
                                   <0.003
                                    0.0009

                                      50
                           4, 8, 12, 16, 20, 24, 28
                                      28
                                   <0.002
                                     0.013
                                   <0.006
                                    0.0021
Liver
                                       5
                                      28
                                       4
                                   <0.014
                                   <0.032
                                   <0.023
                                     0.007

                                      15
                                      28
                                       4
                                   <0.022
                                   <0.037
                                   <0.030
                                     0.006

                                      50
                                      28
                                       4
                                   <0.059
                                   <0.089
                                   <0.070
                                     0.014
Kidney
                                       5
                                      28
                                       4
                                   <0.010
                                   <0.010
                                   <0.010
                                       0

                                      15
                                      28
                                       4
                                   <0.010
                                   <0.014
                                   <0.012
                                     0.002

                                      50
                                      28
                                       4
                                   <0.019
                                   <0.040
                                   <0.034
                                     0.009
Muscle
                                       5
                                      28
                                       4
                                   <0.004
                                   <0.004
                                   <0.004
                                       0

                                      15
                                      28
                                       4
                                   <0.004
                                   <0.006
                                   <0.005
                                     0.001

                                      50
                                      28
                                       4
                                   <0.007
                                   <0.008
                                   <0.007
                                    0.0005
Fat
                                       5
                                      28
                                       3
                                   <0.006
                                   <0.013
                                   <0.009
                                     0.004

                                      15
                                      28
                                       4
                                   <0.018
                                     0.030
                                   <0.022
                                     0.005

                                      50
                                      28
                                       4
                                   <0.044
                                   <0.113
                                   <0.075
                                     0.033
[1]	As residues in milk appeared to plateau by Study Day 4, collected samples from Days 4-28 were used to calculate average residues.  Tissue samples were collected from animal sacrificed within 24 hours of receiving the final dose.
[2]	The LOQ for combined acequinocyl residues (expressed in parent equivalents) is 0.02 ppm in all matrices; the combined LOD was estimated by the reviewer to be 0.004 ppm in fat and muscle, and 0.010 ppm in liver and kidney.  Values proceeded by a "<" indicate that residues of one or more of the analytes were below the LOD.

Expected secondary residues in meat and milk

To determine the need for tolerances for acequinocyl residues in tissues, the anticipated secondary residues in cattle matrices were estimated using transfer coefficient factors calculated from the maximum residues of acequinocyl observed in the ruminant feeding study.  Only the tissue matrices with detectable residues (>0.02 ppm) are shown below in Table 7.  The transfer coefficients (calculated as residue-level-to-feed ratios) are also show in Table 7.  The transfer coefficient for each matrix was then used to calculate the expected secondary residues by multiplying the transfer coefficient by the calculated dietary burden (Table 8).

Table 7.  Residue-Level-to-Feed Ratios (Transfer Coefficients) in Dairy Tissues.
Matrix
                             Maximum Residue (ppm)
                              Feeding Level, ppm
                            Transfer Coefficient[1]
Liver
                                   <0.032
                                       5
                                  <0.0064
                               Ave. = <0.003

                                   <0.037
                                      15
                                   <0.002

                                   <0.089
                                      50
                                  <0.0018

Kidney
                                   <0.040
                                      50
                                  <0.0008
Fat
                                     0.030
                                      15
                                     0.002
                               Ave. = <0.002

                                   <0.113
                                      50
                                  <0.0023

[1]  Calculated from the maximum residues divided by the dose level.

Table 8.  Expected Secondary Residues in Meat.
Matrix
                             Dietary burden (ppm)
                          Secondary Residues (ppm)[1]
                            Established Tolerance
                                     (ppm)
                          HED-Recommended Tolerance
                                     (ppm)
                                  Notes to RD
Liver
                                     1.73
                                    0.0052
                                    0.02[2]
                                      --
A new tolerance of 0.02 ppm in/on cattle, goat, horse, and sheep meat byproducts should be established to cover residues in liver and kidney.
Kidney

                                    0.0014
                                       -
                                    0.02[1]

Fat

                                    0.0035
                                     0.02
                                     0.02
The currently-established tolerance is adequate.
[1]  Calculated from dietary burden x average transfer coefficient from Table 7.
[2]  The established liver tolerance should be removed in 40 CFR §180.599 with the establishment of a new meat byproducts tolerance.

Conclusions:  The feeding study data indicate that the currently established tolerance level at 0.02 ppm for residues in cattle, goat, horse, and sheep fat are appropriate.  The established 0.02-ppm residue level in cattle, goat, horse, and sheep liver are appropriate; however, the commodity definition should be changed to "meat byproducts" rather than "liver."  With the establishment of the cattle, goat, horse, and sheep tolerance in meat byproducts, RD should remove the tolerance for liver.  Furthermore, the meat byproducts tolerance of 0.02 ppm is adequate to cover residues in the kidney of cattle, goats, horses, and sheep.  A revised Section F should be submitted.

860.1500 Crop Field Trials

DER References:	48462901.der (bean, succulent shelled)
		48462902.der (caneberry)
		48462903.der (cantaloupe)
		48462904.der (cherry)
		48462905.der (cucumber)

No new data were submitted to support tolerances on succulent soybean vegetables, low-growing berry 13-07G crop subgroup, or small fruit vine climbing subgroup 13-07F, except fuzzy kiwifruit.  A summary of the data submitted for the proposed new crops can be found below.

Succulent soybean vegetable
No new data were submitted for this crop; however, an edible-podded bean tolerance is established in 40 CFR §180.599 at 0.25 ppm.  IR-4 has requested that this tolerance be extended to support a succulent soybean vegetable tolerance.

Conclusion:  HED recommends that a tolerance at 0.25 ppm in/on edible-podded beans should be extended to soybean, vegetable, succulent.

Low-growing berry subgroup 13-07G
No new data were submitted for this crop subgroup; however, a strawberry tolerance is established in 40 CFR §180.599 at 0.40 ppm.  IR-4 has requested that this tolerance be extended to support a low-growing berry 13-07G subgroup crop tolerance.

Conclusions:  HED recommends that the established strawberry tolerance be extended to the low-growing berry 13-07G crop subgroup.  The OECD Calculator shows that the data support a tolerance of 0.40 ppm for the low-growing berry subgroup 13-07G (which includes strawberries).  Canada has a MRL of 0.5 ppm in/on strawberries.  In order to harmonize with Canada, HED recommends establishing a tolerance of 0.50 ppm for this subgroup.  A revised Section F should be submitted.  With establishment of this crop subgroup, the strawberry tolerance in 40 CFR §180.599 should be removed.

Small fruit vine climbing subgroup 13-07F, except fuzzy kiwifruit

No new data were submitted for this crop subgroup; however, a grape tolerance is established in 40 CFR §180.599 at 1.6 ppm.  IR-4 has requested that this tolerance be extended to support small fruit vine climbing subgroup 13-07F, except fuzzy kiwifruit tolerance.

Conclusions:  HED recommends that the established grape tolerance be extended to small fruit vine climbing subgroup 13-07F, except fuzzy kiwifruit at 1.6 ppm.  With establishment of this crop subgroup, the grape tolerance in 40 CFR §180.599 should be removed.

IR-4 submitted field trial data in support of the proposed uses on succulent shelled beans, caneberry, cantaloupe, cherry, and cucumber.  The results of the field trials are summarized in Table 9.

Table 9.  Summary of Residue Data from Crop Field Trials with Acequinocyl.
Commodity
                              Total Applic. Rate
                                   (lb ai/A)
                                  PHI (days)
              Total Acequinocyl and Acequinocyl-OH Residues (ppm)

                                       n
                                     Min.
                                     Max.
                                    LAFT[1]
                                    HAFT[1]
                                    Median
                                     Mean
                                   Std. Dev.
BEAN, SUCCULENT SHELLED (proposed use = 0.6 lb ai/A total application rate, 7-day PHI)[2]
Bean seeds without pods
                                  0.610-0.911
                                      6-8
                                      14
                                   <0.06
                                   <0.125
                                   <0.06
                                   <0.173
                                     0.06
                                     0.081
                                     0.04
Bean plants with pods
                                  0.610-0.911
                                      6-9
                                      14
                                   <0.34
                                     3.03
                                   <0.345
                                     2.59
                                     1.69
                                     1.58
                                     0.96
CANEBERRY, SUBGROUP 13-07A (proposed use = 0.6 lb ai/A total application rate, 1-day PHI)[3]
Raspberry
                                  0.584-0.606
                                       1
                                       5
                                   <0.13
                                     2.28
                                   <0.28
                                     1.91
                                     0.801
                                     0.958
                                     0.711
Blackberry
                                  0.607-0.612
                                       1
                                       2
                                     0.564
                                     0.785
                                     0.606
                                     0.675
                                     0.606
                                     0.640
                                      --
MELON SUBGROUP 9A (proposed use = 0.6 lb ai/A total application rate, 1-day PHI)[4]
Cantaloupe
                                  0.602-0.833
                                       1
                                      16
                                   <0.025
                                   <0.122
                                   <0.027
                                   <0.089
                                   <0.039
                                     0.040
                                     0.01
   CHERRY (proposed use = 0.6 lb ai/A total application rate, 7-day PHI)[5]
Cherry, tart
                                 0.6042-0.6211
                                      6-7
                                      12
                                   <0.160
                                   <0.481
                                   <0.170
                                   <0.461
                                     0.290
                                     0.319
                                     0.115
Cherry, sweet
                                 0.5836-0.6204
                                      6-7
                                      12
                                   <0.060
                                   <0.216
                                   <0.062
                                   <0.216
                                     0.135
                                     0.140
                                     0.054
  CUCUMBER (proposed use = 0.6 lb ai/A total application rate, 1-day PHI)[6]
Cucumber, field
                                  0.567-0.625
                                       1
                                       8
                                   <0.02
                                   <0.069
                                   <0.02
                                   <0.061
                                     0.044
                                     0.042
                                     0.018
Cucumber, greenhouse
                                  0.597-0.604
                                       1
                                       2
                                   <0.029
                                   <0.093
                                   <0.030
                                   <0.069
                                     0.037
                                     0.049
                                       -
[1]  LAFT = lowest-average-field-trial; HAFT = highest-average-field-trial.
[2]  Total residues = Acequinocyl (corrected for storage decline where applicable) + Acequinocyl-OH.  LOQ = 0.02 ppm for each analyte.
[3]  Total residues = Acequinocyl + Acequinocyl-OH (corrected for concurrent recovery where applicable).  LOQ = 0.01 ppm for each analyte.
[4]  Total residues = Acequinocyl (corrected for storage decline where applicable) + Acequinocyl-OH.  LOQ = 0.015 ppm for acequinocyl; 0.01 for acequinocyl-OH.
[5]  Total residues = Acequinocyl + Acequinocyl-OH.  LOQ = 0.01 ppm for each analyte.
[6]  Total residues = Acequinocyl (corrected for storage dissipation) + Acequinocyl-OH.  LOQ = 0.01 ppm for each analyte.

Bean, Succulent Shelled

IR-4 has submitted field trial data for acequinocyl on succulent shelled beans and bean plant with the pod (seed removed).  Seven bean field trials were conducted in North American Free Trade Agreement (NAFTA) Growing Zone 10 (CA; 2 trials), Zone 2 (GA, 2 trials), Zone 5 (OH; 1 trial), Zone 2 (SC; 1 trial), and Zone 11 (WA; 1 trial) during the 2006 growing season.

At each site, a 1.25 lb/gal SC formulation of acequinocyl was applied to beans as two foliar-directed applications at rates of 0.302-0.378 lb ai/A/application, with a 14- to 15- day RTI, for a total rate of 0.610-0.680 lb ai/A (except in the case of one CA trial where a third application was made for a total rate of 0.911 lb ai/A).  Applications were made using ground equipment in spray volumes of 36-72 gal/A, without a spray adjuvant.  Applications were timed so that commercially mature succulent bean seed without pods could be collected at a 6- to 8-day PHI and commercially mature bean plants with pods (seed removed) could be collected at a 6- to 9-day PHI.  A residue-decline study was not conducted.

Total combined residues of acequinocyl (corrected for decline during storage) and acequinocyl-OH in/on bean seeds without pods ranged from <0.06-<0.125 ppm, harvested 6-8 days following foliar applications of the SC formulation for a total rate of 0.610-0.911 lb ai/A.  Total combined residues of acequinocyl and acequinocyl-OH in/on bean plants with pods ranged from <0.34-3.03 ppm, harvested 6-9 days following foliar applications of the SC formulation for a total rate of 0.610-0.911 lb ai/A (see Table 9).

Conclusions:  The submitted succulent bean field trial data are acceptable and reflect the use of the acequinocyl 1.25 lb/gal SC formulation as two foliar applications for a total rate of 0.610-0.911 lb ai/A (trial 06-CA*28 reflected three applications of approximately 0.303 lb ai/A, for a total of 0.909 lb ai/A), with a 6- to 8-day PHI.

Total combined residues of acequinocyl (corrected for decline during storage) and acequinocyl-OH in/on bean seeds without pods ranged from <0.06-<0.125 ppm, harvested 6-8 days following foliar applications of the SC formulation for a total rate of 0.610-0.911 lb ai/A.  Total combined residues of acequinocyl and acequinocyl-OH in/on bean plants with pods ranged from <0.34-3.03 ppm, harvested 6-9 days following foliar applications of the SC formulation for a total rate of 0.610-0.911 lb ai/A.

The residue data for bean seeds without pods and bean plants with pods were entered separately into the OECD MRL Calculator.  Based on the results of these trials, the appropriate tolerance for residues of acequinocyl and acequinocyl-OH in/on bean, succulent shelled is 0.30 ppm and cowpea, forage is 6.0 ppm.  Typically, forage is harvested before the plant has bloomed.  However, the label does not specify at what plant stage the product can be applied.  The plants were harvested and analyzed after the plants were blooming/fruiting.  Therefore, HED deems it necessary to establish a tolerance on cowpea, hay as well.  There is typically a 3-fold drying factor between forage and hay.  As HED is recommending for a tolerance for residues in/on cowpea, forage at 6.0 ppm, a tolerance for residues of acequinocyl and acequinocyl-OH in/on cowpea, hay at 18 ppm should be established.  A revised Section F should be submitted.

Caneberries

The IR-4 has submitted field trial data for acequinocyl in/on caneberries.  Five supervised crop field trials for acequinocyl in/on raspberries and two supervised crop field trials for acequinocyl in/on blackberries were conducted in the U.S. and Canada during the 2007 growing season encompassing NAFTA Growing Zones 2 (1 raspberry trial in NJ), 5A (1 raspberry trial in MI), 10 (1 blackberry trial in CA), and 12 (1 raspberry trial in BC, 1 raspberry trial in OR, and 1 blackberry trial in OR).  At each trial site, acequinocyl (formulated as Kanemite(TM) 15 SC) was applied to caneberries as 2 foliar directed or broadcast applications at rates of 0.289-0.313 pounds ai/A, with RTIs of 15-23 days, for a total seasonal application rate of 0.584-0.612 pounds ai/A.  Applications were made in spray volumes ranging from 51-111 gallons/A.  No adjuvants were used in any of the spray mixtures.  Commercially mature berries were harvested at a PHI of 1 day.  At the QC03 trial site, mature berries were harvested at additional PHIs of 0, 4, 6, and 11 days to assess residue-decline behavior.

Total residues of acequinocyl and acequinocyl-OH (corrected for concurrent recoveries) in/on raspberries treated at total rates of 0.584-0.606 pounds ai/A/season and harvested at a PHI of 1 day ranged from <0.13-2.28 ppm.  Total residues of acequinocyl and acequinocyl-OH (corrected for concurrent recoveries) in/on blackberries treated at total rates of 0.607-0.612 pounds ai/A/season and harvested at a PHI of 1 day ranged from 0.564-0.785 ppm (Table 9).  Residue-decline data indicated that total residues of acequinocyl and acequinocyl-OH in/on raspberries declined with increasing PHIs.

Conclusions:  The supervised crop field trials for acequinocyl in/on caneberries are considered scientifically valid.  Kanemite(TM) 15 SC was applied to raspberries and blackberries as 2 foliar applications at rates total rates of 0.584-0.612 pounds ai/A/season and harvested commercially mature caneberries at a PHI of 1 day.  Total residues of acequinocyl and acequinocyl-OH (corrected for concurrent recoveries) in/on raspberries ranged from <0.13-2.28 ppm.  Total residues of acequinocyl and acequinocyl-OH (corrected for concurrent recoveries) in/on blackberries ranged from 0.564-0.785 ppm.  Residue-decline data in/on raspberries indicated that total residues of acequinocyl and acequinocyl-OH in/on raspberries declined with increasing PHIs.

The residue data for raspberries were entered into the OECD MRL Calculator (although field trial data were submitted for blackberries, there were not enough data to input into the OECD calculator).  Note that for caneberries, crop subgroup 13-07A, the representative crop is either raspberry or blackberry.  A minimum of five trials is required on any one blackberry or any one raspberry if a tolerance is sought on "caneberries."  Based on the results of these trials, the appropriate tolerance for residues of acequinocyl and acequinocyl-OH in/on "caneberry subgroup 13-07A" is 4.0 ppm.  A revised Section F is requested.

Cantaloupe

IR-4 has submitted field trial data for acequinocyl on cantaloupe.  Six cantaloupe trials were conducted in NAFTA Growing Zone 2 (SC; 1 trial), Zone 5 (OH, 1 trial), Zone 6 (TX; 1 trial), and Zone 10 (NM, AZ, and CA; 3 trials) during the 2007 growing season.

At the trial sites, a 1.25 lb/gal SC formulation of acequinocyl was applied to cantaloupe as two broadcast foliar application at rates of 0.299-0.307 lb ai/A/application for a total rate of 0.600-0.609 lb ai/A (except in the case of one OH trial where a third application was made for a total rate of 0.833 lb ai/A).  Applications were made at 20- to 21-day RTIs except for the OH trial, where the second application was made at a 15-day RTI.  Applications were made using ground equipment in spray volumes of 33-49 gal/A, without a spray adjuvant.  Applications were timed so that the cantaloupe could be collected at a 1-day PHI.  A residue-decline study was conducted at the NM trial where sampling was conducted at a 0-, 1-, 3-, 6-, and 9- day PHIs.

Total combined residues of acequinocyl (corrected for decline during storage) and acequinocyl-OH (calculated in parent equivalents) in/on cantaloupe ranged from <0.025-<0.122 ppm, harvested 1 day following foliar applications of the SC formulation for a total rate of 0.602-0.833 lb ai/A (Table 9).  The residue-decline trial (PHI = 0, 1, 3, 6, and 9 day) showed that residues declined from 0-3 days, then remained <LLMV.

Conclusions:  The submitted cantaloupe field trial data are acceptable and reflect the use of the acequinocyl 1.25 lb/gal SC formulation as two broadcast foliar applications for a total rate of 0.600-0.609 lb ai/A (trial -OH*01 reflected three applications for a total of 0.833 lb ai/A), with a 1-day PHI.  .

Total combined residues of acequinocyl (corrected for decline during storage) and acequinocyl-OH in/on cantaloupe ranged from <0.025-<0.122 ppm, harvested 1 day following foliar applications of the SC formulation for a total rate of 0.602-0.833 lb ai/A.  The residue-decline trial (PHI = 0, 1, 3, 6, and 9 day) showed that residues declined from 0-3 days, then remained <LLMV.

The residue data for cantaloupe were entered into the OECD MRL Calculator.  Based on the results of these trials, the appropriate tolerance for residues of acequinocyl and acequinocyl-OH in/on cantaloupe is 0.15 ppm.  As cantaloupe is the representative commodity for melon subgroup 9A, the tolerance can be expanded to this subgroup.  A revised Section F is requested.

Cherry

IR-4 has submitted data from 12 cherry field trials on acequinocyl during the 2006 growing season.  Six tart cherry field trials were conducted in NAFTA Growing Zone 1 (NY; 1 trial), Zone 5 (MI, 4 trials), and Zone 9 (CO; 1 trial).  Six sweet cherry field trials were conducted in NAFTA Growing Zone 5 (MI; 2 trials), Zone 10 (CA, 2 trials), and Zone 11 (WA; 2 trials).

At the trial sites, a 1.25 lb ai/gal SC formulation of acequinocyl was applied as two foliar directed applications at a rate of ~0.303 lb ai/A each, for a total of 0.5836-0.6211 lb ai/A.  The applications were made at 13- to 15-day RTIs and timed so that marketable pitted cherries could be collected at an approximately 7-day PHI after the second application.  Additional samples for decline determination were collected from the MI08 (tart) and CA29 (sweet) trials at 2- or 3-, 10-, and 14-day PHIs.  Applications were made using ground equipment in spray volumes of ~40-315 gal/A, without a spray adjuvant.

Total combined residues of acequinocyl and acequinocyl-OH (and per-trial averages) in/on tart cherries ranged from <0.160-<0.481 ppm (<0.170-<0.461 ppm), harvested 6-7 days following foliar directed applications of the SC formulation for a total rate of 0.6042-0.6211 lb ai/A.  Total combined residues of acequinocyl and acequinocyl-OH (and per-trial averages) in/on sweet cherries ranged from <0.060-<0.216 ppm (<0.062-<0.216 ppm), harvested 6-7 days following foliar applications of the SC formulation for a total rate of 0.5836-0.6204 lb ai/A (Table 9).  In general, residues were higher in tart cherries than in sweet cherries.  Both the tart and sweet cherry residue-decline trials (PHI = 0, 2 or 3, 6 or 7, 10, and 14 day) showed that residues increased slightly at the first interval, and then declined.

Conclusions:  The submitted cherry field trial data (6 trials on tart cherries, 6 trials on sweet cherries) are acceptable and reflect the use of the acequinocyl 1.25 lb ai/gal SC formulation as two foliar directed applications for a total rate of 0.5836-0.6211 lb ai/A, with a 6-7-day PHI.  Additional samples for decline determination were collected from two trials at 2 or 3, 6 or 7, 10, and 14 days.

Total combined residues of acequinocyl and acequinocyl-OH (and per-trial averages) in/on tart cherries ranged from <0.160-<0.481 ppm (<0.170-<0.461 ppm), harvested 6-7 days following foliar directed applications of the SC formulation for a total rate of 0.6042-0.6211 lb ai/A.  Total combined residues of acequinocyl and acequinocyl-OH (and per-trial averages) in/on sweet cherries ranged from <0.060-<0.216 ppm (<0.062-<0.216 ppm), harvested 6-7 days following foliar applications of the SC formulation for a total rate of 0.5836-0.6204 lb ai/A.  In general, residues were higher in tart cherries than in sweet cherries.  Both the tart and sweet cherry residue-decline trials (PHI = 0, 2 or 3, 6 or 7, 10, and 14 day) showed that residues increased slightly at the first interval, and then declined.

The residue data for tart and sweet cherries were separately entered into the OECD MRL Calculator.  Based on the results of these trials, the appropriate tolerances for residues of acequinocyl and acequinocyl-OH are 1.0 ppm in/on cherry, tart and 0.50 ppm in/on cherry, sweet.  A revised Section F is requested.

Cucumbers

IR-4 has submitted field trial and greenhouse data for acequinocyl in/on cucumbers.  Nine supervised crop field trials in/on field cucumbers (pickling and slicing varieties) were conducted in the U.S. during the 2007 growing season encompassing NAFTA Growing Zones 2 (2 trials in GA, 1 trial in NC), 5 (2 trials in OH), 6 (1 trial in TX) and 10 (2 trials in CA).  At each trial site, acequinocyl [formulated as Kanemite(TM) 15 SC] was applied to field cucumbers as 2 foliar broadcast or foliar directed applications at rates of 0.263-0.325 pounds ai/A, at RTIs of 19-23 days, for a total rate of 0.567-0.636 pounds ai/A/season.  The applications were made in spray volumes ranging from 32-77 gallons/A.  No adjuvants were used in any of the spray mixtures.  Commercially mature field cucumbers were harvested at a PHI of 1 day.  At the GA*15 trial site, field cucumbers were harvested at additional PHIs of 0, 4, 7, and 9 days to assess residue-decline behavior.

In addition, two greenhouse cucumber trials were conducted in the U.S. and Canada during the 2007 growing season encompassing NAFTA Growing Zones 2 (1 trial in NJ) and 5 (1 trial in ON).  At each trial site, acequinocyl (formulated as Kanemite(TM) 15 SC) was applied to greenhouse cucumbers as two foliar-directed applications at rates of 0.296-0.303 pounds ai/A, at RTIs of 19-20 days, for a total rate of 0.597-0.604 pounds/A/season.  The applications were made in spray volumes ranging from 53-188 gallons/A.  No adjuvants were used in any of the spray mixtures.  Commercially mature greenhouse cucumbers were harvested at a PHI of 1 day.  At the ON01 trial site, greenhouse cucumbers were harvested at additional PHIs of 0, 3, 7, and 9 days to assess residue-decline behavior.

Total residues of acequinocyl (corrected for storage dissipation) and acequinocyl-OH in/on field cucumbers treated at total rates of 0.567-0.625 pounds ai/A/season (636-701 g ai/ha/season) and harvested at a PHI of 1 day ranged from <0.02-<0.069 ppm (Table 9).  Residue-decline data indicated that total residues of acequinocyl and acequinocyl-OH in/on field cucumbers declined with increasing PHIs.

Total residues of acequinocyl (corrected for storage dissipation) and acequinocyl-OH in/on greenhouse cucumbers treated at total rates of 0.597-0.604 pounds ai/A/season (669-677 g ai/ha/season) and harvested at a PHI of 1 day ranged from <0.029-<0.093 ppm (Table 9).  Residue-decline data indicated that total residues of acequinocyl and acequinocyl-OH in/on greenhouse cucumbers declined with increasing PHIs.

Conclusions:  The submitted crop field trials for acequinocyl in/on field cucumbers and greenhouse cucumbers are considered scientifically valid.  Kanemite(TM) 15 SC was applied to field cucumbers as two foliar (broadcast or directed) applications at rates total rates of 0.567-0.625 lbs ai/A and mature field cucumbers were harvested at a PHI of 1 day.  Total residues of acequinocyl (corrected for storage dissipation) and acequinocyl-OH in/on field cucumbers ranged from <0.02-<0.069 ppm.  Residue decline data indicated that total residues of acequinocyl and acequinocyl-OH in/on field cucumbers declined with increasing PHIs.  Kanemite(TM) 15 SC was also applied to greenhouse cucumbers as two foliar (broadcast or directed) applications at total rates of 0.597-0.604 lbs ai/A and mature greenhouse cucumbers were harvested at a PHI of 1 day.  Total residues of acequinocyl (corrected for storage dissipation) and acequinocyl-OH in/on greenhouse cucumbers ranged from <0.029-<0.093 ppm.  Residue decline data indicated that total residues of acequinocyl and acequinocyl-OH in/on greenhouse cucumbers declined with increasing PHIs.

The residue data for field and greenhouse cucumbers were entered into the OECD MRL Calculator (see ChemSAC minutes, 19-OCT-2011).  Running the OECD MRL Calculator both with and without the greenhouse cucumber data resulted in the same tolerance level of 0.15 ppm.  Based on the results of these trials, the appropriate tolerance for residues of acequinocyl and acequinocyl-OH is 0.15 ppm in/on cucumber.

860.1520 Processed Food and Feed

There are no processed food/feed items associated with the proposed uses.  Therefore, data requirements for this guideline are not relevant to this tolerance petition.

860.1650 Submittal of Analytical Reference Standards

Analytical reference standards for acequinocyl and acequinocyl-OH are currently available at the EPA National Pesticide Standards Repository (electronic communication with Theresa Cole, 31-OCT-2011) with expiration dates of June, 2012.

860.1850/1900 Confined and Field Accumulation in Rotational Crops

The proposed uses under this petition include succulent soybeans, berries (subgroup 13-07G), succulent shelled beans, cowpea forage, cucumbers, and melons (subgroup 9A) which are typically rotated crops.  An acceptable confined rotational crop study was previously submitted (Memo, S. Levy, 25-JUN-2008; DP#s 351336 & 353313) in support of uses on strawberries.  The study results (47332501.der) showed the extent and nature of the residue uptake by crops (lettuce, turnip and wheat) planted 30-, 120- and 365-days post-application in soil treated with [14]C-acequinocyl at 0.60 lb ai/A (1x maximum registered/proposed seasonal application rate to rotated crops).  The available data support a 30-day PBI for all non-labeled crops, which is reflected on the proposed label.

860.1550 Proposed Tolerances

Tolerances are currently established under 40 CFR §180.599(a) for the combined residues of acequinocyl and its metabolite, 2-dodecyl-3-hydroxy-1,4-naphthoquinone, expressed as acequinocyl equivalents, in/on a number of plant and livestock commodities.  Tolerances for plant commodities range from 0.02 ppm (tree nuts and pistachios) to 30 ppm (citrus oil), and tolerances for livestock commodities are established at 0.02 ppm in the fat and liver of cattle, goat, horse, and sheep.  Compliance with the tolerance levels specified below in Table 10 is to be determined by measuring acequinocyl and its metabolite, 2-dodecyl-3-hydroxy-1,4-naphthoquinone, expressed as acequinocyl equivalents.

There are currently no established Codex, Canadian, or Mexican MRLs for acequinocyl residues in/on cucumbers or caneberries.  Data for these crops were jointly reviewed by the U.S. and Canada.  The data support tolerance levels of 0.15 ppm and 0.40 ppm, respectively.  These levels are harmonized between the U.S. and Canada.

Canada has a MRL of 0.5 ppm for residues in/on strawberries.  The OECD Calculator shows that the data support a tolerance of 0.40 ppm for residues in/on the low-growing berry subgroup 13-07G (which includes strawberries); however, in order to harmonize with Canada, HED recommends establishing a tolerance of 0.50 ppm for residues in this subgroup.  Canada also has a MRL for residues of 0.02 ppm in/on meat byproducts of cattle, goat, horse, and sheep. HED is recommending for the same tolerance level as Canada; therefore, harmonization will not be an issue.

Table 10.  Tolerance Summary for Acequinocyl.
Commodity
                           Proposed Tolerance (ppm)
                        HED-Recommended Tolerance (ppm)
Comments;
Correct Commodity Definition
Soybean, vegetable, succulent
                                     0.25
                                     0.25
Established edible-podded bean tolerance extended to soybean, vegetable, succulent.
Low-growing berry subgroup
13-07G
                                      0.4
                                     0.50
Established strawberry tolerance extended for a subgroup tolerance.  With establishment of this subgroup tolerance, the strawberry tolerance should be removed.
Small fruit vine climbing subgroup 13-07F, except fuzzy kiwifruit
                                      1.6
                                      1.6
Established grape tolerance extended for a subgroup tolerance.  With establishment of this subgroup tolerance, the grape tolerance should be removed.
Bean, succulent shelled
                                     0.15
                                     0.30

Cowpea, forage
                                      9.0
                                      6.0

Cowpea, hay
                                      --
                                      18

Caneberry subgroup 13-07A
                                      4.5
                                      4.0

Melon subgroup 9A
                                     0.06
                                     0.15

Cucumber
                                     0.15
                                     0.15

Cherry
                                      0.8
                                      1.0
Cherry, tart

                                      --
                                     0.50
Cherry, sweet
Liver of cattle, goat, horse, and sheep[1]
                                      --
                                     0.02
Meat byproducts of cattle, goat, horse and sheep
[1]  A tolerance of 0.02 ppm is already established under 40 CFR §180.599; however, the commodity definition should be changed to meat byproducts to cover residues in liver and kidney.

Conclusions:  The petitioner should submit a revised Section F with the appropriate commodity definitions and/or HED-recommended tolerance levels listed in Table 15.  Furthermore, the Section F should state the following (as it appears in 40 CFR §180.599):  "Tolerances are established for residues of acequinocyl, 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 the sum of acequinocyl [2-(acetyloxy)-3-dodecyl-1,4-naphthalenedione] and its metabolite, 2-dodecyl-3-hydroxy-1,4-naphthoquinone, calculated as the stoichiometric equivalent of acequinocyl, in or on the commodity."  A revised Section F should be submitted.

References

DP#:		297872
Subject:	Acequinocyl.  Report of the Metabolism Assessment Review Committee (MARC).  Meeting Date:  17-DEC-2003.
From:		S. Levy/P. Terse
Dated:	07-JAN-2004
MRID:		None

DP#:		298917
From:		S. Levy
Dated:		18-FEB-2004
MRID:		45651603

DP#s:		284757, 290204, 286425
Subject:	Acequinocyl.  Registration for Use on Pome Fruits, Citrus, Almonds, Pistachios, and Strawberry.  Summary of Analytical Chemistry and Residue Data.
From:		S. Levy
Dated:		10-MAR-2004
MRID(s):	46602001-46602003

DP#:		321753
Subject:	Acequinocyl.  Response to Submission of MRID#s 46602001, 46602002 and 46602003 by Morse Laboratories Addressing a Need for Confirmation of Acequinocyl in Fruits, Almonds and Livestock Tissues.
From:		D. Soderberg and S. Levy
Dated:		23-MAY-2006
MRID(s):	46602001-46602003

DP#s:		330439, 337218, 337472
Subject:	Acequinocyl.  Petitions for Uses on Tree Nuts and Grapes.  Summary of Analytical Chemistry and Residue Data.
From:		S. Levy
Dated:		05-SEP-2007
MRID(s):	46776602, 47032402, & 46952301

DP#s:		351336 & 353313
Subject:	Acequinocyl; Review of Petitioner's Amendment Dated 28-JUN-2008 Submitted in Response to the Health Effects Division (HED) Memoranda, DP# 284757 (dated 10-MAR-2004).
From:		S. Levy
Dated:		25-JUN-2008
MRID:	47332501

DP#:		380302
Subject:	Acequinocyl; Response to the Health Effects Division (HED) Review of 25-JUN-2008 (Memoranda, DP#s D351336 & D353313).
From:		S. Levy
Dated:		25-AUG-2010
MRID(s):	48016603-48016605

Attachments:
International Residue Limit Status (IRLS) Sheet.
Appendix I -Tolerance Assessment Calculations.

RDI:  G. Kramer (02-NOV-2011); RAB1 Chemists (09-NOV-2011)
S. Levy:S-10953:PY1:(703)305-0783:7509P
IRLS Sheet.
                   Acequinocyl (PC Code 006329; 10/28/2011)
Summary of U.S. and International Tolerances and Maximum Residue Limits
Residue Definition:
U.S.
Canada
Mexico[2]
Codex[3]
40 CFR 180.599
Plants/Livestock: sum of acequinocyl [2-(acetyloxy)-3-dodecyl-1,4-naphthalenedione] and its metabolite, 2-dodecyl-3-hydroxy-1,4-naphthoquinone, calculated as the stoichiometric equivalent of acequinocyl
2-(acetyloxy)-3-dodecyl-1,4-naphthalenedione, including the metabolite 2-dodecyl-3-hydroxy-1,4-naphthalenedione

None
Commodity[1]
Tolerance (ppm) /Maximum Residue Limit (mg/kg)

                                     U.S.
Canada
Mexico[2]
Codex[3]
Soybean, vegetable, succulent
                                     0.25

Low-growing berry subgroup
13-07G
                                     0.40
0.5 strawberries

Small fruit vine climbing subgroup 13-07F, except fuzzy kiwifruit
                                      1.6

Bean, succulent shelled
                                     0.30

Cowpea, forage
                                      6.0

Cowpea, hay
                                      18

Caneberry subgroup 13-07A
                                      4.0

Melon subgroup 9A
                                     0.15

Cucumber
                                     0.15

Cherry, sweet
                                     0.50

Cherry, tart
                                      1.0

Meat byproducts of cattle, goat, horse, and sheep
                                     0.02
0.02 Meat byproducts of cattle, goat, horse, and sheep

Completed:  M. Negussie; 10/31/2011
[1] Includes only commodities of interest for this action.  Tolerance values should be the HED recommendations and not those proposed by the applicant.
2 Mexico adopts U.S. tolerances and/or Codex MRLs for its export purposes.
3 * = absent at the limit of quantitation; Po = postharvest treatment, such as treatment of stored grains.  PoP = processed postharvest treated commodity, such as processing of treated stored wheat. (fat) = to be measured on the fat portion of the sample. MRLs indicated as proposed have not been finalized by the CCPR and the CAC.

Appendix I.  Tolerance Assessment Calculations.

Succulent Shelled Beans

The submitted U.S. residue data for succulent shelled beans (seeds without pods) and succulent bean plants with pods (7 data points each) were entered into the OECD MRL Calculator in order to determine appropriate tolerance levels.

Compound
Crop

Region / Country
GAP

Total number of data (n)

Percentage of censored data
Number of non-censored data

Lowest residue
Highest residue
Median residue

Mean
Standard deviation (SD)

Correction factor for censoring (CF)

Proposed MRL estimate

- Highest residue
- Mean + 4 SD
- CF x 3 Mean
Unrounded MRL

Rounded MRL

                                  Acequinocyl
                           Bean, succulent shelled
                              (seeds w/out pods )

                                      USA
                                  0.610-0.911

                                       7

                                      0%
                                       7

                                     0.060
                                     0.173
                                     0.060

                                     0.081
                                     0.043

                                     1.000

                                     0.173
                                     0.251
                                     0.243
                                     0.251

                                      0.3

Residues (mg/kg)
                                     0.060

                                     0.060

                                     0.173

                                     0.095

                                     0.060

                                     0.060

                                     0.060

Compound
Crop

Region / Country
GAP

Total number of data (n)

Percentage of censored data
Number of non-censored data

Lowest residue
Highest residue
Median residue

Mean
Standard deviation (SD)

Correction factor for censoring (CF)

Proposed MRL estimate

- Highest residue
- Mean + 4 SD
- CF x 3 Mean
Unrounded MRL

Rounded MRL

Residues (mg/kg)
                                     0.527
                                     1.690
                                     2.590
                                     2.460
                                     0.952
                                     0.345
                                     2.510

                                  Acequinocyl
                                 Cowpea forage
                             (bean plants w/pods)

                                      USA
                                  0.610-0.911

                                       7

                                      0%
                                       7

                                     0.345
                                     2.590
                                     1.690

                                     1.582
                                     0.975

                                     1.000

                                     2.590
                                     5.481
                                     4.746
                                     5.481

                                       6

Caneberry Subgroup 13-07A

The submitted U.S. residue data for raspberry (5 data points) and blackberry (2 data points) were entered into the OECD MRL Calculator in order to determine an appropriate crop group tolerance level.

Compound
Crop

Region / Country
GAP

Total number of data (n)

Percentage of censored data
Number of non-censored data

Lowest residue
Highest residue
Median residue

Mean
Standard deviation (SD)

Correction factor for censoring (CF)

Proposed MRL estimate

- Highest residue
- Mean + 4 SD
- CF x 3 Mean
Unrounded MRL

Residues (mg/kg)
                                     0.280
                                     1.910
                                     1.474
                                     0.325
                                     0.801

                                  Acequinocyl
                                  Raspberries

                                      USA
                                  0.584-0.612

                                       5

                                      0%
                                       5

                                     0.280
                                     1.910
                                     0.801

                                     0.958
                                     0.717

                                     1.000

                                     1.910
                                     3.827
                                     2.874
                                     3.827

                                       4

Melon Subgroup 9A
The submitted U.S. residue data for cantaloupe (8 data points) were entered into the OECD MRL Calculator in order to determine an appropriate crop group tolerance level.

Compound
Crop

Region / Country
GAP

Total number of data (n)

Percentage of censored data
Number of non-censored data

Lowest residue
Highest residue
Median residue

Mean
Standard deviation (SD)

Correction factor for censoring (CF)

Proposed MRL estimate

- Highest residue
- Mean + 4 SD
- CF x 3 Mean
Unrounded MRL

Residues (mg/kg)
                                     0.027
                                     0.047
                                     0.039
                                     0.039
                                     0.061
                                     0.027
                                     0.030
                                     0.035

                                  Acequinocyl
                               Melon subgroup 9A
                                 (cantaloupe)

                                      USA
                                  0.602-0.833

                                       8

                                      0%
                                       8

                                     0.027
                                     0.061
                                     0.037

                                     0.038
                                     0.012

                                     1.000

                                     0.061
                                     0.084
                                     0.114
                                     0.114

                                     0.15

Cucumber
The submitted U.S. residue data for field (8 data points) cucumbers were entered into the OECD MRL Calculator in order to determine an appropriate tolerance level.

Compound
Crop

Region / Country
GAP

Total number of data (n)

Percentage of censored data
Number of non-censored data

Lowest residue
Highest residue
Median residue

Mean
Standard deviation (SD)

Correction factor for censoring (CF)

Proposed MRL estimate

- Highest residue
- Mean + 4 SD
- CF x 3 Mean
Unrounded MRL

Residues (mg/kg)
                                     0.020
                                     0.031
                                     0.060
                                     0.058
                                     0.020
                                     0.061
                                     0.056
                                     0.031
                                     0.069
                                     0.030

                                  Acequinocyl
                                  Cucumbers
  (field and greenhouse)

                                      USA
                                  0.567-0.625

                                      10

                                      0%
                                      10

                                     0.020
                                     0.069
                                     0.044

                                     0.044
                                     0.019

                                     1.000

                                     0.069
                                     0.119
                                     0.131
                                     0.131

                                     0.15

Cherry
The submitted U.S. residue data for sweet (6 data points) and tart (6 data points) cherries were entered into the OECD MRL Calculator in order to determine appropriate tolerance levels.

Compound
Crop

Region / Country
GAP

Total number of data (n)

Percentage of censored data
Number of non-censored data

Lowest residue
Highest residue
Median residue

Mean
Standard deviation (SD)

Correction factor for censoring (CF)

Proposed MRL estimate

- Highest residue
- Mean + 4 SD
- CF x 3 Mean
Unrounded MRL

Residues (mg/kg)
                                     0.118
                                     0.151
                                     0.192
                                     0.216
                                     0.105
                                     0.062

                                  Acequinocyl
                                 Cherry, sweet

                                      USA
                                 0.5836-0.6204

                                       6

                                      0%
                                       6

                                     0.062
                                     0.216
                                     0.135

                                     0.141
                                     0.057

                                     1.000

                                     0.216
                                     0.370
                                     0.422
                                     0.422

                                      0.5

Compound
Crop

Region / Country
GAP

Total number of data (n)

Percentage of censored data
Number of non-censored data

Lowest residue
Highest residue
Median residue

Mean
Standard deviation (SD)

Correction factor for censoring (CF)

Proposed MRL estimate

- Highest residue
- Mean + 4 SD
- CF x 3 Mean
Unrounded MRL

Residues (mg/kg)
                                     0.315
                                     0.460
                                     0.461
                                     0.170
                                     0.270
                                     0.240

                                  Acequinocyl
                                 Cherry, tart

                                      USA
                                 0.6024-0.6211

                                       6

                                      0%
                                       6

                                     0.170
                                     0.461
                                     0.293

                                     0.319
                                     0.119

                                     1.000

                                     0.461
                                     0.796
                                     0.958
                                     0.958

                                       1


August 30, 2005 Mr. Larry Wallace USEPA Mail Code ( C504 02) Research Triangle Park, North Carolina 27711 Dear Mr. Wallace:

Listed below are the Oklahoma Department of Environmental Quality's comments on the " Staff Work Paper on the Use of Air Quality Data Related to Exceptional and Natural Events for the Particulate Matter Standards" and recommendations for modifications to the proposed language for the rule.

1. Ozone  The State and Territorial Air Pollution Program Administrators and the Association of Local Air Pollution Control Officials ( STAPPA/ ALAPCO) briefing on July 27, 2005 included a discussion of the pollutants to be included in the rule and specified that ozone is to be included. The staff work paper needs to be clear that the rule will apply not only to particulate matter ( PM), but also to ozone.

2. Public Hearings  States should hold public hearings if there is sufficient public input but a hearing should not be mandated for all Exceptional Event/ Natural Event ( EE/ NE) requests. If a hearing must be held within the 60 day request timeline, an extension may be necessary. Many states have requirements that they must give a 30 day notice of any public hearing, which makes holding the hearing within the 60 day request timeline almost impossible.

3. Website Tracking  EPA should develop a website that contains all the information for EE/ NEs, all requests and concurrences, and provides examples for states to quickly determine what is expected. We also suggest that this website provide resources such as links to relevant websites and documents. This would expedite the process of searching for sources of data when working under a tight deadline.

4. Request Deadline  The 60 day EE/ NE request deadline should be extended. The Oklahoma Department of Environmental Quality as well as many other agencies and tribes contract with outside labs to perform the PM2.5 filter analysis. This process often requires 50 to 70 days, or longer, to receive the data from the lab. Even adding a 30 day extension request would make the timeframe very tight. To make a PM2.5 EE/ NE request feasible, we suggest increasing the deadline to 90 days. Mr. Larry Wallace August 30, 2005 Page 2 5. Modeling Time Frame  Listed on pages 6 and 7 of the staff work paper is the idea that modeling is one of the means that we are allowed to use as the basis of our request. If a state wishes to use modeling of an event, additional time will be necessary to complete the modeling. There may need to be an additional mechanism set up for the state and region to agree to additional time required to perform modeling.

6. Tribal Monitors  There are many monitors located on tribal lands that must be shown the same consideration as those located on state and federal land. However, many tribes may lack the resources to make an EE/ NE request or to develop an EEMAP. Will the Region or the State take this responsibility for them, or will they be provided with some form of assistance?

7. Inversions and Stagnation Events  While routine or even yearly meteorological events should not be discounted, there should be some mechanism for addressing truly exceptional inversions or stagnation events. Under this current version, none of this would qualify as exceptional. We believe that inversions and/ or stagnation events should qualify under the policy if states can convincingly prove that the event occurs with less than a specified frequency that is indicative of a rare or abnormal occurrence.

8. PM2.5 Standard  Compared to the form of the ozone standard, which averages the 4th highest values over 3 years, the form of the PM2.5 24 hour standard, which averages values at the 98th percentile over 3 years, is not very forgiving. Many of the PM2.5 sites run every 6 days, having 65 to 66 sample days a year with 100% data capture. If the sample number were reduced as a result of all the sample collection/ data problems normally encountered in a year, the average sample number would range from 55 to 60 days. The 98th percentile, for any site yielding less than 50 samples per year, is the highest value. For sites yielding less than 100 samples per year, the 98th percentile is the 2nd highest value. For the year 2004, Oklahoma had 19 sites, one of which had less than 50 samples and 9 other sites that had less than 100 samples. Therefore, for most of our sites the 2nd highest value each year is critical and even a small impact from an event that lasts more than 5 days has the potential to force the site into non attainment. Given the sensitivity of the form of the PM2.5 standard to EE/ NEs, and the probability that the standard will be changed to a much tighter value when the review of the standard has been completed, it is critical that the guidance not be over complicated and or burdensome for either EPA or the States and Tribes. Many events that were ignored in the past will now threaten the attainment status of an area and must be worked as an EE/ NE.

We appreciate the opportunity for input. Should you have any questions or need additional information, please feel free to contact Scott Thomas at 405 702 4100.

Sincerely,

Eddie Terrill, Director Air Quality Division ET: nlm: hlb


[Federal Register Volume 78, Number 124 (Thursday, June 27, 2013)]
[Notices]
[Pages 38798-38799]
[FR Doc No: 2013-15401]

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DEPARTMENT OF TRANSPORTATION

National Highway Traffic Safety Administration

[Docket No. DOT-NHTSA-2013-0028]

Request for Comments on a New Information Collection

ACTION: Notice and request for comments.

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SUMMARY: In compliance with the Paperwork Reduction Act of 1995 (44
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FOR FURTHER INFORMATION CONTACT: Mr. Patrick Hallan,<PHONE_NUMBER>,
NHTSA, U.S. Department of Transportation, 1200 New Jersey Avenue SE.,
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SUPPLEMENTARY INFORMATION:
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    OMB Control Number: 2127-0521.
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Transportation, 725 17th Street NW., Washington, DC 20503, Attention
NHTSA Desk Officer or to the Docket Management System, Docket Number
NHTSA-2013-0028 at http://www.regulations.gov/.
    Comments are invited on: Whether the proposed collection of
information is necessary for the proper performance of the functions of
the Department, including whether the information will have practical
utility; the accuracy of the Department's estimate of the burden of the
proposed information collection; ways to enhance the quality, utility
and

clarity of the information to be collected; and ways to minimize the
burden of the collection of information on respondents, including the
use of automated collection techniques or other forms of information
technology.

    Authority:  The Paperwork Reduction Act of 1995; 44 U.S.C.
Chapter 35, as amended; and 49 CFR 1:48.

    Issued on: June 21, 2013.
Christopher J. Bonanti
Associate Administrator for Rulemaking.
[FR Doc. 2013-15401 Filed 6-26-13; 8:45 am]
BILLING CODE 4910-59-P