  SEQ CHAPTER \h \r 1 

	UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, D.C.  20460

OFFICE OF           

PREVENTION, PESTICIDES

AND TOXIC SUBSTANCES

MEMORANDUM

Date:		27-May-2009

Subject:	Spinosad.  Application of Spinosad to Date, Pomegranate, Tree
Nuts (crop group 14), and Pistachio.  Summary of Analytical Chemistry
and Residue Data.  

PC Code:  110003	DP Barcode:  D358163

Decision No.:  400738	Registration Nos.:  62719-282; 62719-292

Petition No.:  8E7445	Regulatory Action:  Section 3 Registration and
Label Amendment

Risk Assessment Type:  not applicable	Case No.:  not applicable

TXR No.:  not applicable	CAS Nos.:  131929-60-7 and 131929-63-0

MRID No:  47554001	40 CFR:  180.495



From:		Tom Bloem, Chemist

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

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

			HED/RAB1 (7509P)

	

To:			Daniel Rosenblatt (RM 05)

			Registration Division (7505P) 

The Interregional Research Project Number 4 (IR-4) requested a Section 3
registration for application of spinosad to date and pomegranate and a
label amendment for tree nuts (crop group 14) and pistachio.  The
petitioner is also proposing the establishment of the following
tolerances for the combined residues of spinosyn A and D:  almond, hulls
- 9.0 ppm; nut, tree, group 14 - 0.08 ppm; pistachio - 0.08 ppm; date -
0.1 ppm; and pomegranate - 0.3 ppm.  

Executive Summary

Background:  Spinosad is a fermentation product of Saccharopolyspora
spinosa, a naturally occurring soil organism.  The product consists of
two related active ingredients:  spinosyn A and spinosyn D.  The two
active ingredients differ by one methyl group and are typically present
at an 85:15 ratio (A:D).  The registrant indicated that the exact mode
of action is not known but is characterized by excitation of the insect
nervous system, leading to involuntary muscle contractions, prostration
with tremors, and paralysis (effects are consistent with excitation of
the nicotinic acetylcholine receptors).  Spinosad is currently
registered for application to numerous crops with tolerances for the
combined residues of spinosyn A and D ranging from 0.01-200 ppm (40 CFR
180.495).  

Application Scenarios:  The petitioner submitted supplemental labeling
for Entrust® (WP (wettable powder); 80% ai; EPA Reg. No. 62719-282) and
Success® (SC (suspension concentrate); 2 lb ai/gal; EPA Reg. No.
62719-292).  Table 3 is a summary of the proposed application scenarios.
 The petitioner should submit a revised Section B specifying a 7-day
retreatment interval (RTI) for dates.  

Nature of the Residue - Plant/Livestock:  The nature of the residue in
plants and livestock is adequately understood based on metabolism
studies conducted with apples, cabbage, cotton, tomatoes, turnips,
ruminants (oral and dermal), and poultry (oral).  HED concluded that the
residue of concern in plants and livestock, for risk assessment and
tolerance enforcement purposes, are spinosyns A and D (D243816, G.
Herndon, 3-Mar-1998; D264984, W. Donovan, 14-Jun-2002).

Magnitude of the Residue - Crops:  The petitioner proposed translating
the spinosad plum residue data to dates and the spinosad avocado
tolerance to pomegranate.  The HED Chemistry Science Advisory Council
(ChemSAC) reviewed and approved these translations (see minutes of
16-Jul-2008 and 27-Aug-2008).  Therefore, HED concludes that the
following tolerance for the combined residues of spinosyn A and D are
appropriate:  pomegranate - of 0.30 ppm and date  - 0.10 ppm.  A revised
Section F is requested.  

In support of the proposed reduction in the preharvest interval (PHI)
for tree nuts and pistachio from 14 days to 1 day, the petitioner
submitted almond (nutmeat and hull; n=5) residue data conducted using
the proposed application scenario.  Combined residues of spinosyn A and
D were as follows:  almond nutmeat - <0.040-0.067 and almond hull -
0.292-5.11.  The petitioner also referenced spinetoram almond (nutmeat
and hull; n=1) and pecan (nutmeat; n=1) field trial data conducted using
the proposed spinosad application scenario.  Combined residues of
XDE-175-J, XDE-175-L, N-demethyl-175-J, and N-formyl-175-J were as
follows (see attachment 2 for structures):  almond nutmeat - <0.040;
almond hull - 1.593 and 1.712; and pecan - <0.040 and <0.041.  Note that
spinetoram is a compound which is structurally similar to spinosad and
HED has previously concluded that spinosad data may be translated to
spinetoram (D325387, T. Bloem, 12-Sep-2007).

at - ≤0.008 ppm; n=4) field trials conducted using the
currently-registered rate yielded similar residues (D237752, G. Herndon,
2-Mar-1998; D277485, G. Herndon, 6-Aug-2001).  

Based on the almond field trial data and the North American Free Trade
Act (NAFTA) Maximum Residue Limit (MRL) Spreadsheet, the tree nut crop
group and the almond hull tolerances should be increased to 0.10 ppm and
19 ppm, respectively.  HED notes that pistachio residue data have not
been submitted and concludes that the tree nut crop group tolerance may
be translated to pistachio (see Reviewer's Guide and Summary of HED
ChemSAC Approvals for Amending Commodity Definitions (40 CFR 180.1(h))
and Crop Group/Subgroups (40 CFR 180.41)).  A revised Section F is
requested.  

Magnitude of the Residue - Livestock:  Based on the revised Table 1
feedstuffs (OPPTS 860.1000), the only feed item associated with the
current petition is almond hulls which are fed to only dairy cattle
(roughage; 10% of the diet; 90% dry matter).  The previously-calculated
dairy cattle maximum dietary burden was 46.354 ppm (D347514, T. Bloem,
24-Apr-2008) with the roughage component of this diet consisting of
nongrass forage (21 ppm; 22% dry matter; 40% of the diet).  Based on the
roughage component of the previously calculated diary cattle diet, HED
concludes that the increase in the almond hull tolerance from 2.0 ppm to
19 ppm will not necessitate an increase in the ruminant tolerances.  

Analytical Enforcement Method:    SEQ CHAPTER \h \r 1 Method RES 94025
(GRM 94.02; cottonseed) has been successfully subjected to an
independent laboratory validation (ILV) as well as an EPA laboratory
validation.  It has been forwarded to Food and Drug Administration (FDA)
for inclusion in the Pesticide Analytical Manual (PAM) II (G. Herndon,
2-Mar-1998).  The following methods have also been submitted to the FDA
for inclusion in PAM II:  GRM 95.17 (leafy vegetables); GRM 96.09
(citrus); GRM 96.14 (tree nuts); GRM 95.04 (fruiting vegetables); GRM
94.02.S1 (cotton gin byproducts); and an immunoassay method which was
validated on 17 different crop matrices (G. Herndon, 18-Feb-1998).  HED
concludes that these methods are sufficient to enforce the tolerances
associated with the current petition.    

Recommendations:  Provided the petitioner submits revised Sections B and
F, HED concludes that the residue chemistry database supports an
unconditional registration and establishment of the following tolerances
for the combined residues of spinosyn A and D (a human-health risk
assessment will prepared as a separate document):  almond, hulls - 19
ppm; nut, tree, group 14 - 0.10 ppm; pistachio - 0.10 ppm; date - 0.10
ppm; and pomegranate - 0.30 ppm.  

Summary of Residue Chemistry Deficiencies

(Revised Section B.

(Revised Section F.

Detailed Considerations 

Background

Spinosad is a fermentation product of Saccharopolyspora spinosa, a
naturally-occurring soil organism.  The product consists of two related
active ingredients:  Spinosyn A and Spinosyn D.  The two active
ingredients differ by one methyl group and are typically present at an
85:15 ratio (A:D).  The registrant indicated that the exact mode of
action is not known but is characterized by excitation of the insect
nervous system, leading to involuntary muscle contractions, prostration
with tremors, and paralysis (effects are consistent with excitation of
the nicotinic acetylcholine receptors).  Spinosad is used for the
control of many foliage feeding pests including lepidopterous larvae,
leafminers, and thrips.  Table 1 is a summary of the spinosad
nomenclature; Table 2 is a summary of the physical chemical properties
for spinosad.  

Table 1:  Test Compound Nomenclature.

Chemical Structure	



Common name	Spinosad

Company experimental name	XDE-105

IUPAC name	Spinosyn A: 
(2R,3aS,5aR,5bS,9S,13S,14R,16aS,16bR)-2-(6-deoxy-2,3,4-tri-O-methyl-αa-
L-mannopyranosyloxy)-13-(4-dimethylamino-2,3,4,6-tetradeoxy-βß-D-eryth
ropyranosyloxy)-9-ethyl-2,3,3a,5a,5b,6,7,9,10,11,12,13,14,15,16a,16b-hex
adecahydro-14-methyl-1H-8-oxacyclododeca[b]as-indacene-7,15-dione;
Spinosyn D:  (2S,3aR,5aS,5bS,9S,13S,14R,16aS,
16bR)-2-(6-deoxy-2,3,4-tri-O-methyl-αa-L-mannopyranosyloxy)-13-(4-dimet
hylamino-2,3,4,6-tetradeoxy-βß-D-erythropyranosyloxy)-9-ethyl-2,3,3a,5
a,5b,6,7,9,10,11,12,13,14,
15,16a,16b-hexadecahydro-4,14-dimethyl-1H-8-oxacyclododeca[b]as-indacene
-7,15-dione

CAS name	Spinosyn A: 
2-[(6-deoxy-2,3,4-tri-O-methyl-α-L-manno-pyranosyl)oxy]-13-[[5-(dimethy
lamino)-tetrahydro-6-methyl-2H-pyran-2-yl]oxy]-9-ethyl-2,3,3a,5a,5b,6,9,
10,11,
12,13,14,16a,16b-tetradecahydro-14-methyl-1H-as-Indaceno[3,2-d]oxacyclod
odecin-7,15-dione; Spinosyn D: 
2-[(6-deoxy-2,3,4-tri-O-methyl-α-L-manno-pyranosyl)oxy]-13-[[5-(dimethy
lamino)-tetrahydro-6-methyl-2H-pyran-2-yl]oxy]-9-ethyl-2,3,3a,5a,5b,6,9,
10,
11,12,13,14,16a,16b-tetradecahydro-4,14-methyl-1H-as-Indaceno[3,2-d]oxac
yclododecin-7,15-dione

CAS #	Spinosyn A:  131929-60-7; Spinosyn D:  131929-63-0



Table 2:  Physicochemical Properties of the Technical Grade Test
Compound.

Melting ranges	Spinosyn A: 84-99.5°C; Spinosyn D: 161.5-170°C	EPA Fact
Sheet



pH (10% slurry of spinosad in water)	7.74

	Density at 20°C	0.512

	Water solubility (ppm)	Spinosyn A: 89.4; Spinosyn D: 0.495

	Vapor pressure at 25°C (kPa)	Spinosyn A: 3.0 x 10-11; Spinosyn D: 2.0
x 10-11

	Dissociation constant (pKa)	not available

	Octanol/water partition coefficient Log(KOW)	Spinosyn A:  2.8 (pH 5);
4.0 (pH 7); 5.2 (pH 9)

Spinosyn D:  3.2 (pH 5); 4.5 (pH 7); 5.2 (pH 9)

	UV/visible absorption spectrum	not available

	OPPTS GLN 860.1200  Directions for Use

The petitioner submitted supplemental labeling for Entrust® (WP; 80%
ai; EPA Reg. No. 62719-282) and Success® (SC; 2 lb ai/gal; EPA Reg. No.
62719-292).  Table 3 is a summary of the proposed application scenarios.
 The petitioner should submit a revised Section B specifying a 7-day RTI
for dates.  

Table 3:  Proposed Application Scenarios.

Formulation	Rate

(lb ai/acre)	No. Apps.	Max. Sea. Rate (lb ai/acre)	PHI (days)	Comments

tree nuts and pistachio

Entrust® (WP; 80% ai; EPA Reg. No. 62719-282) Success® (SC; 2 lb
ai/gal; EPA Reg. No. 62719-292)	0.062-0.156	not indicated	0.45	1	-7-day
RTI

-dilute and concentrate sprays are permitted

-crop oils may be added to the spray solution

pomegranate

Entrust® (WP; 80% ai; EPA Reg. No. 62719-282)	0.062-0.125	not indicated
0.45	7	-10-14-day RTI

-dilute and concentrate sprays are permitted

-spray adjuvants may be adder to the spray solution

date

Entrust® (WP; 80% ai; EPA Reg. No. 62719-282)	0.125	not indicated	0.45
7	-RTI not indicated

-dilute and concentrate sprays are permitted

-crop oils may be added to the spray solution

1  PHI = preharvest interval; RTI = retreatment interval.  

860.1300 Nature of the Residue - Plants and Livestock

The nature of the residue in plants and livestock is adequately
understood based on metabolism studies conducted with apples, cabbage,
cotton, tomatoes, turnips, ruminants (oral and dermal), and poultry
(oral).  HED concluded that the residue of concern in plants and
livestock, for risk assessment and tolerance enforcement purposes, are
spinosyns A and D (D243816, G. Herndon, 3-Mar-1998; D264984, W. Donovan,
14-Jun-2002).

OPPTS GLN 860.1340 Residue Analytical Methods

47554001.der.doc

Tolerance Enforcement:  Adequate plant methods are available for
enforcement of the tolerance associated with the current petition. 
These methods are listed below.

Method RES 94025 (GRM 94.02) is an high-performance liquid chromatograph
with ultraviolet detection (HPLC/UV) method which was originally
submitted for the determination of spinosad residues of concern in/on
cottonseed and related commodities.  The method has been successfully
subjected to an ILV as well as an EPA laboratory validation.  It has
been forwarded to FDA for inclusion in PAM II as Method I (Memorandum,
G. Herndon, 2-Mar-1998).

The following additional methods have been submitted for other crop
matrices:  GRM 95.17 for leafy vegetables; GRM 96.09 for citrus; GRM
96.14 for tree nuts; GRM 95.04 for fruiting vegetables; and GRM 94.02.S1
for cotton gin byproducts.  All of these methods are essentially similar
to GRM 94.02 and have been submitted to FDA for inclusion in PAM II as
‘letter’ methods (D242940, G. Herndon, 18-Feb-1998).

In conjunction with PP#8F5002, another petitioner (Dow AgroSciences) has
proposed the immunochemical methods GRM 96.10.S1 (cereal grain
commodities, cucurbits, and legumes), GRM 96.11.S1 (stone fruits), and
GRM 97.05 (sorghum fodder) for tolerance enforcement.  These methods all
employ the extraction methods of the HPLC enforcement methods previously
accepted by the Agency.  The immunoassay methods typically require less
sample cleanup than their HPLC counterparts; thus, transfer of extracted
residues into the final extract should be equal to or greater than that
which occurs with the HPLC methods.  Both GRM 96.11.S1 and GRM 97.05
have undergone successful independent laboratory validation.  A number
of HPLC/UV and HPLC/MS (mass spectrometry) methods are available for
confirmation (e.g., GRM 96.09, GRM 97.06).

Data Collection:  In support of the current petition, spinosad almond
nutmeat and hull field trial data were submitted.  The samples from this
study were analyzed for residues of spinosyn A and D using Dow
AgroSciences method GRM 96.14; as indicated above, Method GRM 96.14 is a
valid tolerance enforcement method.  Based on the acceptable recoveries
provided as part of the field trial study and since the method is
approved for tolerance enforcement, HED concludes that the method is
adequate for data collection.

OPPTS GLN 860.1360 Multiresidue Methods

Data pertaining to multiresidue methods testing of spinosyns A, D, B,
and K and N-demethyl spinosyn D were forwarded to the FDA for review (S.
Willett, 23-Jan-1997; G. Herndon, 1-May-1996).  

OPPTS GLN 860.1380 Storage Stability

47554001.der.doc

The almond nutmeat and hull samples were stored frozen for ≤554 days
prior to analysis.  In conjunction with the field trial data, storage
stability data were submitted which indicated that residues of spinosyn
A and D are stable in almond nutmeat and hull when stored frozen for 572
days and 601 days, respectively.  Therefore, the sample storage
intervals are supported by the available storage stability data.  

OPPTS GLN 860.1480 Meat, Milk, Poultry, and Eggs

Based on the revised Table 1 feedstuffs (OPPTS 860.1000), the only feed
item associated with the current petition is almond hulls which are fed
to only dairy cattle (roughage; 10% of the diet; 90% dry matter).  The
previously-calculated dairy cattle maximum dietary burden was 46.354 ppm
(D347514, T. Bloem, 24-Apr-2008) with the roughage component of this
diet consisting of nongrass forage (21 ppm; 22% dry matter; 40% of the
diet).  Based on the roughage component of the previously calculated
diary cattle diet, HED concludes that the increase in the almond hull
tolerance from 2.0 ppm to 19 ppm will not necessitate an increase in the
ruminant tolerances.  

860.1500 Crop Field Trials

47554001.der.doc

HED notes that a reduced spinosad residue data set for numerous crops
and translation of spinosad residue data for certain crops were
considered acceptable due to spinosad’s low toxicity and residue
chemistry profile (i.e., low use rates, incorporation of spinosad
metabolites into the general carbon pool, etc; D252416, G. Herndon,
1999-Feb-23).  Currently, spinosad is registered for application to
nearly all of the crop groups with the most recent human-health risk
assessment yielding exposures less than HED's level of concern while
assuming 100% crop treated for all food crop commodities (D354053, T.
Bloem, 26-Jun-2008).  The following are HED's conclusion concerning the
magnitude of spinosad residues as a result of the proposed application
scenarios.  

Date:  The petitioner proposed translating the previously-reviewed
Californian spinosad plum/prune residue data to date (for plum/prune
data see D249374 (M. Doherty, 24-Jun-1999)).  The plum field trials
employed four applications at 0.062-0.134 lb ai/acre (0.5-1.1x; final
two applications at 1.1x) for a total application rate of 0.45 lb
ai/acre (1.0x; RTI = 7 days).  The prune field trials employed four
applications at 0.219-0.468 lb ai/acre (1.8-3.7x; final two applications
at 3.7x) for a total application rate of 1.56 lb ai/acre (3.5x; RTI = 7
days).  Samples were harvested 7 days after the final application and
analyzed for spinosad residues using an adequately-validated
immunochemical method (Method GRM 96.11; limit of quantitation (LOQ) =
0.018 ppm).  Spinosad residues were as follows:  plum (n=12) - <0.018,
prune (fresh; n=8) - 0.04-0.08 ppm; and prune (dried; n=8) - 0.03-0.08
ppm.  

The petitioner sent a request directly to the ChemSAC concerning
translation of the plum residue data to dates.  Based on the identical
application scenarios and since California is the major growing region
in the U.S. for dates, the ChemSAC approved the translation of the
Californian plum data to dates (see minutes of 27-Aug-2008 meeting). 
HED concludes that use of the NAFTA MRL tolerance calculator is not
appropriate as the application scenario for plum and prune were not
consistent; based on the available data, HED concludes that a date
tolerance for the combined residues of spinosyn A and D of 0.10 ppm is
appropriate.  A revised Section F is requested.  

Pomegranate:  The petitioner proposed translating the spinosad avocado
tolerance (0.3 ppm) to pomegranate.  HED notes that the spinosad avocado
tolerance was translated from the citrus, stone fruit, and apple residue
data (1x the proposed pomegranate application rate; RTI = 6-7 days; PHI
= 1 day for citrus and 7 days for apple and stone fruit; for discussion
concerning this translation see D252416 (G. Herndon, 23-Feb-1999)). 
Based on the similar use patterns, the ChemSAC approved the translation
of the avocado tolerance to pomegranate (see minutes of 16-Jul-2008
meeting).  Therefore, HED concludes that a pomegranate tolerance for the
combined residues of spinosyn A and D of 0.30 ppm is appropriate.  A
revised Section F is requested

Pistachio and Tree Nuts:  Tolerances for the combined residues of
spinosyn A and D in/on pistachio, tree nuts, and almond hulls are
currently established at 0.020 ppm, 0.02 ppm, and 2.0 ppm, respectively.
 The petitioner is proposing a reduction in the PHI for pistachio and
tree nuts from 14 days to 1 day.  In support of this request, the
petitioner submitted almond (nutmeat and hull) field trial data (n=5)
data conducted using the proposed application scenario (SC (2 lb
ai/gallon); 3 x 0.154-0.158 lb ai/acre; RTI = 6-7 days; PHI = 1 day). 
Combined residues of spinosyn A and D were as follows (see below for
complete summary):  almond nutmeat - <0.040-0.067 and almond hull -
0.292-5.11.  The petitioner also referenced spinetoram almond (nutmeat
and hull; n=1) and pecan (nutmeat; n=1) field trial data conducted using
the proposed spinosad application scenario (WDG (water dispersible
granule; 25%); 4 x 0.104-0.129 lb ai/acre; RTI = 6-8 days; PHI = 1 day).
 Combined residues of XDE-175-J, XDE-175-L, N-demethyl-175-J, and
N-formyl-175-J were as follows (see 47468301.der.doc; see attachment 3
for structures):  almond nutmeat - <0.040; almond hull - 1.593 and
1.712; and pecan - <0.040 and <0.041.  Note that spinetoram is a
compound which is structurally similar to spinosad and HED has
previously concluded that spinosad data may be translated to spinetoram
(D325387, T. Bloem, 12-Sep-2007).

HED generally requests the submission of 5 almond (nutmeat and hull) and
5 pecan field trials for establishment of a tree nut crop group
tolerance.  The petitioner has fulfilled the almond field trial
requirements but has submitted only one pecan residue trial.  HED
concludes that additional pecan residue data are unnecessary for the
following reasons:  (1) spinosad has low toxicity; (2) spinosad is
currently registered for application to nearly all crop groups with the
most recent human-health risk assessment yielding exposures less than
HED's level of concern while assuming 100% crop treated for food
commodities (D354053, T. Bloem, 26-Jun-2008); (3) the spinetroam pecan
(n=1) and spinosad almond (n=5) field trials conducted at the proposed
rate yielded similar residues; and (4) the almond (nutmeat - <0.009 ppm;
n=6) and pecan (nutmeat - ≤0.008 ppm; n=4) field trials conducted
using the currently-registered rate yielded similar residues (D237752,
G. Herndon, 2-Mar-1998; D277485, G. Herndon, 6-Aug-2001).  

Based on the almond field trial data and the NAFTA MRL Spreadsheet, the
tree nut crop group and the almond hull tolerances should be increased
to 0.10 ppm and 19 ppm, respectively (see attachment 2).  The MLE
calculator was used to calculate tree nut crop group tolerance as the
residue >LOQ appeared to be log normally distributed.  HED notes that
pistachio residue data have not been submitted and concludes that the
tree nut crop group tolerance may be translated to pistachio (see
Reviewer's Guide and Summary of HED ChemSAC Approvals for Amending
Commodity Definitions (40 CFR 180.1(h)) and Crop Group/Subgroups (40 CFR
180.41)).  A revised Section F is requested.

47554001.der.doc:  Residue data for five spinosad almond field trials
conducted in Zone 10 (CA (n=5)) were submitted.  The treated plot at
each trial received three broadcast foliar applications of Success® 2SC
(suspension concentrate; 2 lb ai/gallon) at 0.154-0.158 lb ai/acre (RTI
= 6-7 days).  Almond nutmeat and hull samples were collected 1 and 3
days after the final application.  The harvested samples were analyzed
for residues of spinosyn A and D using an adequately validated method
(storage intervals were also validated).  Based on the lower limt of
method validation (LLMV), the LOQ for all relevant analyte/matrices is
0.02 ppm.  Combined residues of spinosyn A and D in/on almond nutmeat
and hull were as follows:  almond nutmeat:  <0.040-0.067 (PHI = 1 day)
and <0.040-0.062 ppm (PHI = 3 days) and  almond hull:  0.292-5.11 (PHI =
1 day) and 0.152-4.60 ppm (PHI = 3 days).  Table 4 is a summary of the
almond field trial data.

Table 4:  Summary of Residue Data from Crop Field Trials with
Flutriafol. 

Commodity	Analytes	Total App. Rate (lb ai/acre)	PHI (days)	n	Residue
(ppm)1





	Min.	Max.	HAFT2	Median	Mean	Std. Dev.

almond nutmeat	spinosyn A and D	0.464-0.469	1	10	<0.040	0.067	0.062
0.046	0.050	0.011

	spinosyn A and D

3-4	10	<0.040	0.062	0.061	0.040	0.045	0.009

almond 

hull	spinosyn A and D

1	10	0.292	5.11	4.79	2.94	2.70	1.86

	spinosyn A and D

3-4	10	0.152	4.60	4.41	2.67	2.45	1.86

1  For the determination of the HAFT, median, mean, and standard
deviation, the LOQ (0.02 ppm) was assumed for residues reported as <LOQ.

2  HAFT = highest-average field trial.

OPPTS 860.1520 Processed Food and Feed

Based on Table 1 of OPPTS 860.1000, there are no processed commodities
associated with pistachio, tree nuts, and pomegranate; therefore
processing studies are unnecessary for these crops.  For date, Table 1
of OPPTS 860.1000 indicates that dried date is a processed commodity for
date.  Based on the dried prune processing data (0.74-0.96x; D249374, M.
Doherty, 24-Jun-1999), a separate tolerance in/on dried date is
unnecessary.  

OPPTS 860.1850/1900 Confined/Field Accumulation in Rotational Crops

Since date, pomegranate, pistachio, and tree nuts are not rotated, a
discussion concerning the nature/magnitude of the residue in rotational
crops is unnecessary.  

860.1550 Proposed Tolerances

Table 5 is a summary of the proposed and HED-recommended tolerances for
the combined residues of spinosyn A and D (a revised Section F is
requested).  There are currently-established Codex almond hull (2 ppm)
and nutmeat (0.01 ppm) MRLs (spinosyn A and D) and a Mexican walnut (2
ppm) MRL (spinosad).  HED concludes that harmonization with these
tolerance is not possible as the HED recommended tolerance are either
significantly greater or lower than those currently established by Codex
and in Mexico. 

Table 5:  Tolerance Summary.

Proposed	HED-Recommended 

Commodity Definition	Tolerance (ppm)1	Commodity Definition	Tolerance
(ppm)1

almond, hulls	9.0	almond, hulls	19

nut, tree, group 14	0.08	nut, tree, group 14	0.10

pistachio	0.08	pistachio	0.10

date	0.1	date	0.10

pomegranate	0.3	pomegranate	0.30

1  Proposed and recommended tolerance expression for the combined
residues of spinosyn A and spinosyn D.  

Attachment 1:  IRLS Sheet.

Attachment 2:  Structures.

Attachment 3:  NAFTA MRL Calculations.

  SEQ CHAPTER \h \r 1 RDI: RAB1 Chemists (13-May-2009)

T. Bloem:S10945:Potomac Yard 1:703-605-0217:7509P:RAB1

Attachment 1:  IRLS Sheet.

INTERNATIONAL RESIDUE LIMIT STATUS

Chemical Name: 

Spinosyn
A:(2R,3aS,5aR,5bS,9S,13S,14R,16aS,16bR)-2-(6-deoxy-2,3,4-tri-O-methyl-α
a-L-mannopyranosyloxy)-13-(4-dimethylamino-2,3,4,6-tetradeoxy-βß-D-ery
thropyranosyloxy)-9-ethyl-2,3,3a,5a,5b,6,7,9,10,11,12,13,14,15,16a,
16b-hexadecahydro-14-methyl-1H-8-oxacyclododeca[b]as-indacene-7,15-dione

Spinosyn D:
(2S,3aR,5aS,5bS,9S,13S,14R,16aS,16bR)-2-(6-deoxy-2,3,4-tri-O-methyl-αa-
L-mannopyranosyloxy)-13-(4-dimethylamino-2,3,4,6-tetradeoxy-βß-D-eryth
ropyranosyloxy)-9-ethyl-2,3,3a,5a,5b,6,7,9,10,11,12,13,14,15,16a,
16b-hexadecahydro-4,14-dimethyl-1H-8-oxacyclododeca[b]as-indacene-7,15-d
ione	Common Name:

spinosad	X Proposed tolerance

(Reevaluated tolerance

( Other - recommended tolerances	Date: 

29-Apr-2009

Codex Status (MRLs)	U. S. Tolerances

( No Codex proposal step 6 or above

( No Codex proposal step 6 or above for the crops requested	Petition
Number: 8E7445

DP Barcode:  358163

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nut, tree, group 14	0.08



pistachio	0.08



date	0.1



pomegranate	0.3

Limits for Canada	Limits for Mexico

X No Limits

(  No Limits for the crops requested	( No Limits

( No Limits for the crops requested

Residue definition: 	Residue definition:  spinosad

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



Walnut	2.

Notes/Special Instructions:  S.Funk, 04/29/2009.



Attachment 2:  Structures.

 

N-demethyl-175-J



N-formyl-175-J



Spinosyn A

-methyl-α-L-mannopyranosyl)oxy]-13-[[(2R,5S,6R
)-5-(dimethylamino)tetrahydro-6-methyl-2H-pyran-2-yl]oxy]-9-ethyl-2,3,3a
,5a,5b,6,9,10,11,12,13,14,16a,16b-tetradecahydro-14-methyl-1H-as-indacen
o[3,2-d]oxacyclododecin-7,15-dione

	

Spinosyn D

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Attachment 3:  NAFTA MRL Calculations.

Spinosad	Summary of Analytical Chemistry and Residue Data	D358163

page   PAGE  1  of   NUMPAGES  13 

