Document ID: EPA-HQ-OPP-2013-0411-0004
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2014-06-11T04:00Z

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, D.C.  20460

OFFICE OF CHEMICAL SAFETY AND

POLLUTION PREVENTION

MEMORANDUM

Date:		28-July-2010

Subject:	Spirodiclofen in/on the Bushberry Subgroup 13-07B.  Summary of
Analytical Chemistry and Residue Data.

PC Code:  124871	DP Barcode:  D371643

Decision No.:  421907	Registration No.:  264-831

Petition No.:  9E7632	Regulatory Action:  Section 3 

Risk Assessment Type:  not applicable	Case No.:  7443

TXR No.:  not applicable	CAS No.:  148477-71-8

MRID Nos:  47886201	40 CFR:  180.608

From:		Tom Bloem, Chemist

Risk Assessment Branch I, Health Effects Division (RABI/HED; 7509C)

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

		HED/RABI (7509P)

To:		Barbara Madden/Laura Nollen (RM 05)

		Registration Division (RD; 7505P) 

Interregional Research Project Number 4 (IR-4; Princeton, NJ) proposed a
Section 3 registration for application of spirodiclofen
(3-(2,4-dichlorophenyl)-2-oxo-1-oxaspiro[4.5]dec-3-en-4-yl
2,2-dimethylbutanoate; see attachment 1 for structure) to the bushberry
subgroup 13-07B for the control of blueberry budmite.  In conjunction
with the request, the petitioner proposed the establishment of a 4.0 ppm
tolerance for residues of spirodiclofen per se in/on the bushberry
subgroup 13-07B.  

Executive Summary

Background:  Spirodiclofen is a tetronic acid with acaricidal action
(group 23).  It acts by interfering with mite development and controls
such pests as Panonychus spp., Phyllocoptruta spp., Brevipalpus spp.,
and Aculus and Tetranychus species.  The petitioner stated that
spirodiclofen is active by contact to mite eggs, all nymphal stages, and
adult females (adult males are not effected).  Spirodiclofen is
currently registered for application to citrus fruit, grape, pome fruit,
stone fruit, tree nuts, avocado, black sapote, canistel, mamey sapote,
mango, papaya, sapodilla, star apple, and hops with tolerances for
residues of spirodiclofen per se of 0.10-30 ppm; milk and ruminant meat,
meat byproducts, and fat tolerance for the combined residues of
spirodiclofen and BAJ 2510 are also established (0.02-0.1 ppm).   

Proposed Application Scenarios:  The petitioner provided proposed use
directions for application of Envidor® 2 SC Miticide
(suspension-concentrate; 2 lbs ai/gallon; EPA Reg. No. 264-831) to the
bushberry subgroup 13-07B for the control of blueberry budmite (see
Table 1 for summary).  Application through irrigation equipment and in
enclosed structures is prohibited.  Although the label does not indicate
that adjuvants (e. g.; crop-oil concentrate, nonionic surfactant,
methylated seed oil) should be added to the spray solution, it does not
prohibit the inclusion of adjuvants.  Since the field trial data
submitted in support of the proposed action did not include adjuvants,
HED requests a revised Section B prohibiting the addition of adjuvants
to the spray solution.  

Table 1:  Summary of Proposed Application Scenarios.

Applic. Type	Max. Single Applic. Rate (lb ai/acre)	Max. No. Applic. per
Season	PHI1 (days)	Comments

bushberry subgroup 13-07B (aronia berry, highbush blueberry, lowbush
blueberry, Buffalo currant, Chilean guava, 

●Minimum spray volume of 30 gallons per acre.

●Maximum seasonal application rate - 0.28 lb ai/acre.

1  PHI = preharvest interval.

Nature of the Residue - Primary Crops:  Based on the results of
previously submitted apple and grape processing studies and citrus,
grape, and apple metabolism studies (D285249, T. Bloem, 18-Apr-2005;
D341847, T. Bloem, 25-Oct-2007; D359773, T. Bloem, 24-Jun-2009), HED
concluded the following:  (1) citrus fruit, pome fruit, stone fruit, and
tree nut - the residue of concern for risk assessment and tolerance
enforcement is spirodiclofen per se and (2) grape - the residue of
concern for tolerance enforcement is spirodiclofen per se and residues
of concern for risk assessment are spirodiclofen and BAJ 2510.  Since
the grape processing study demonstrated degradation of spirodiclofen to
BAJ 2510, HED is requesting that the petitioner submit an orange
processing study monitoring for residues of spirodiclofen, BAJ 2510,
3-OH-enol, and 4-OH-enol (apple processing study did not demonstrate
this degradation).  Pending the submission of the orange processing
data, human-health risk assessments should assume default processing
factors for all processed commodities excluding the processed
commodities for apple and grape.  

HED is willing to translate these conclusions to the proposed crops. 
Therefore, the residue of concern in the requested crops is
spirodiclofen per se.  The following is a summary of the
currently-available plant metabolism data.  

The apple, citrus, and grape metabolism studies indicate that the
metabolism of spirodiclofen in fruit crops involves the following steps:
 cleavage of the ester linkage to form BAJ 2510; hydroxylation of BAJ
2510 on the cyclohexyl ring to form 3-OH-enol and 4-OH-enol metabolites;
and cleavage of the enol ring structure to form 2,4-dichloro-mandelic
acid-cyclohexylester, which undergoes hydroxylation/conjugation and
further degradation to yield 2,4-dichloro-mandelic acid (free and
conjugated).  The grape processing study indicates that residues of
spirodiclofen degrade to BAJ 2510 during processing of grapes to juice,
juice concentrate, jelly, and raisin (apple processing study did not
demonstrate this).  

The majority of the residues in/on fruit were surface residues or were
associated with the peel with nearly all these being comprised of parent
compound.  Overall, spirodiclofen accounted for 34-99% of the total
radioactive residues (TRR).  Minor amounts of the following compounds
were also identified:  BAJ 2510 (≤2% TRR), 3-OH-enol (≤3% TRR),
4-OH-enol (<1% TRR), 2,4-dichloro-mandelic acid-cyclohexylester
compounds (free and conjugated; ≤9% TRR), and 2,4-dichloro-mandelic
acid (free and conjugate; ≤12% TRR).

Magnitude of the Residue - Primary Crops:  In support of the proposed
registration, six lowbush (North American Free Trade Agreement (NAFTA)
growing zones 1 (n=4) and 5 (n=2)) and six highbush (n=6; NAFTA growing
zones 2 (n=3), 5 (n=1), and 12 (n=2)) blueberry field trials were
submitted.  Provided a revised Section B is submitted, the application
scenario employed in the field trials supports the proposed application
scenario and resulted in spirodiclofen per se residues in/on highbush
and lowbush blueberry of 0.362-1.069 ppm and  0.100-2.333 ppm,
respectively.  Based on these data, the Agency's tolerance calculator
recommended for highbush and lowbush blueberry tolerances for residues
of spirodiclofen per se of 1.4 ppm and 3.5 ppm, respectively.  

The representative commodity for the bushberry subgroup 13-07B is
highbush blueberry with lowbush blueberry included in the subgroup.  HED
notes that additional trials in zones 1 (n=1) and 5 (n=2) are needed to
fulfill the geographical distribution specified in OPPTS 860.1500 for
highbush blueberry.  Since the petitioner submitted six lowbush
blueberry field trials and the data for these trials indicates that
residues are higher in/on lowbush blueberry as compared to highbush
blueberry, HED concludes that additional data are unnecessary.  Based on
the submitted data, HED concludes that a tolerance of 3.5 ppm for
residues of spirodiclofen per se in/on the bushberry subgroup 13-07B is
appropriate.  A revised Section F is requested.  

Analytical Enforcement Method:  HED determined that the Bayer analytical
method 109351 was appropriate for enforcement of the hop, citrus, grape,
pome fruit, stone fruit, and tree nut tolerances and forwarded this
method to Food and Drug Administration (FDA) for inclusion in the
Pesticide Analytical Manual (PAM; D368434, T. Bloem, 23-Sep-2009). 
Based on the similarities of the tolerance enforcement and the
adequately validated data collection methods, HED concludes that the
current enforcement method is appropriate for enforcement of the
tolerances recommended as part of the current petition.  

FDA Multiresidue Methods:  Spirodiclofen and BAJ 2510 were screened
through the FDA MRM protocols.  Since both spirodiclofen and BAJ 2510
are not N-methylcarbamates, naturally fluorescent, acids, phenols, or
substituted ureas, testing through protocols A, B, and G is unnecessary.
 Protocol C modules DG1 and DG10 gave acceptable results for BAJ 2510
and spirodiclofen, respectively (both are GC/ECD systems).  Using
fortified orange samples, acceptable recoveries of spirodiclofen were
attained through Protocols D (80-103%) and E (54-77%).  Using fortified
ground beef samples, unacceptable recoveries of spirodiclofen were
attained through protocol F (16-30%).  BAJ 2510 was not recovered
through the florisil clean-up column, and therefore, gave unacceptable
recoveries for Protocol D (fortified orange samples) and F (fortified
ground beef samples).  Since BAJ 2510 was not recovered through Protocol
D, Protocol E was not tested.  These data have been forwarded to FDA
(D308565, T. Bloem, 29-Sep-2004).

Nature/Magnitude of the Residue - Livestock:  Based on the revised Table
1 feedstuffs (OPPTS 860.1000), none of the proposed crops have feed
commodities; therefore a discussion concerning the nature/magnitude of
the residue in livestock is unnecessary.  

Nature/Magnitude of the Residue - Rotational Crops:  Since all of the
requested crops are perennials, a discussion concerning the
nature/magnitude of the residue in rotational crops is unnecessary.   

Recommendations:  Provided revised Sections B and F are submitted, HED
concludes that the residue chemistry database supports an unconditional
registration for application of spirodiclofen to the bushberry subgroup
13-07B and establishment of the following permanent tolerance for
residues of only spirodiclofen (180.608(a)(1)):  Bushberry subgroup
13-07B - 3.5 ppm.  A human-health risk assessment will be prepared as a
separate document.  

In accordance with the most recent guidance concerning tolerance
expressions, HED recommends that the tolerance expression for
180.608(a)(1) and 180.6(a)(2) be changed as indicated below.  HED notes
that this alteration in the tolerance expression does not necessitate a
change in the currently established or recommended tolerance levels.  A
revised Section F specifying the new tolerance expression, the currently
established commodity/tolerance levels, and the HED-recommended
bushberry subgroup 13-07B tolerance should be submitted.  

180.608(a)(1):  Tolerances are established for residues of
spirodiclofen, including its metabolites and degradates, in or on the
commodities listed below.  Compliance with the following tolerance
levels is to be determined by measuring only spirodiclofen
(3-(2,4-dichlorophenyl)-2-oxo-1-oxaspiro[4.5]dec-3-en-4-yl
2,2-dimethylbutanoate.

180.608(a)(2):  Tolerances are established for residues of
spirodiclofen, including its metabolites and degradates, in or on the
commodities listed below.  Compliance with the following tolerance
levels is to be determined by measuring only spirodiclofen
(3-(2,4-dichlorophenyl)-2-oxo-1-oxaspiro[4.5]dec-3-en-4-yl
2,2-dimethylbutanoate) and its metabolite
3-(2,4-dichlorophenyl)-4-hydroxy-1-oxaspiro[4,5] dec-3-en-2-one.

Summary of Residue Chemistry Deficiencies:

(Revised Section B

(Revised Section F

Detailed Considerations

Background

Spirodiclofen is a tetronic acid with acaricidal action (group 23).  It
acts by interfering with mite development, and controls such pests as
Panonychus spp., Phyllocoptruta spp., Brevipalpus spp., and Aculus and
Tetranychus species.  The petitioner stated that spirodiclofen is active
by contact to mite eggs, all nymphal stages, and adult females (adult
males are not effected).  Tables 2 and 3 are summaries of spirodiclofen
nomenclature and physical chemical properties, respectively.

Common name	Spirodiclofen

Company experimental name	BAJ2740

IUPAC name	3-(2,4-dichlorophenyl)-2-oxo-1-oxaspiro[4,5]dec-3-en-4-yl
2,2-dimethylbutyrate

CAS name	3-(2,4-dichlorophenyl)-2-oxo-1-oxaspiro[4,5]dec-3-en-4-yl
2,2-dimethylbutanoate

CAS registry number	148477-71-8

End-use product (EP)	2 lb/gal FlC (ENVIDOR® 2 SC Miticide; EPA Reg. No.
264-831)

Table 3:  Physicochemical Properties of Spirodiclofen.

Melting point	94.8ºC	D315459, S. Mathur, 

50μg/L

	Solvent solubility (g/L at 20°C)	n-heptane  

xylene  

dichloromethane 

2-propanol

1-octanol

polyethylene glycol

acetone

ethyl acetate

acetonitrile

dimethylsulfoxide	20

>250

>250

47

44

24

>250

>250

>250

75

	Vapor pressure (20ºC)	3 x 10-7 Pa

	Dissociation constant, pKa	Not determinable due to the instability in
aqueous solutions at >pH 4

	Log(KOW) at pH 4 and 20ºC	5.83

	UV/visible absorption spectrum	λmax = 201 nm:  Not expected to absorb
UV at λ >350 nm

	

860.1200  Directions for Use

The petitioner provided proposed use directions for application of
Envidor® 2 SC Miticide (suspension-concentrate; 2 lbs ai/gallon; EPA
Reg. No. 264-831) to the bushberry subgroup 13-07B for the control of
blueberry budmite (see Table 1 for summary).  Application through
irrigation equipment and in enclosed structures is prohibited.  Although
the label does not indicate that adjuvants (e. g.; crop-oil concentrate,
nonionic surfactant, methylated seed oil) should be added to the spray
solution, it does not prohibit the inclusion of adjuvants.  Since the
field trial data submitted in support of the proposed action did not
include adjuvants, HED requests a revised Section B prohibiting the
addition of adjuvants to the spray solution.  

860.1300 Nature of the Residue - Plants

Based on the results of previously submitted apple and grape processing
studies and citrus, grape, and apple metabolism studies (D285249, T.
Bloem, 18-Apr-2005; D341847, T. Bloem, 25-Oct-2007; D359773, T. Bloem,
24-Jun-2009), HED concluded the residue of concern in the proposed crops
is spirodiclofen per se (see Executive Summary for more information).  

860.1300 Nature of the Residue - Livestock

Based on the revised Table 1 feedstuffs (OPPTS 860.1000), none of the
proposed crops have feed commodities; therefore a discussion concerning
the nature of the residue in livestock is unnecessary.  

860.1340 Residue Analytical Methods

Tolerance Enforcement:  HED forwarded Bayer analytical method 109351 to
FDA for inclusion in the PAM (D368434, T. Bloem, 23-Sep-2009).  Briefly,
fruit samples are extracted with acetonitrile:water (2:1; v:v)
containing a small amount of aqueous 20% cysteine hydrochloride,
filtered, and acidified with HCl.  The extract is subjected to clean up
on an ENVI-carb cartridge preconditioned with DCM, methanol, and water
with residues eluted with DCM under vacuum.  The resulting eluent is
concentrated to dryness and reconstituted in ACN and water for analysis
by LC/MS/MS.  The LOQ was reported to be 0.01 ppm (LOD ranged from
0.001-0.006 ppm).  Based on the similarities of the tolerance
enforcement and the adequately validated data collection methods, HED
concludes that the current enforcement method is appropriate for
enforcement of the tolerances recommended as part of the current
petition.  

Data Collection:  The blueberry field trial samples were analyzed for
residues of spirodiclofen per se using an adequately validated liquid
chromatograph/mass spectrometer/mass spectrometer (LC/MS/MS) method. 
Briefly, homogenized samples were extracted by blending with
acetonitrile:water (2:1; v:v) and 20% cysteine hydrochloride.  Samples
were filtered, acidified with 1.2N HCl, and partitioned with
dichloromethane (DCM) prior to analysis by LC/MS/MS.  The submitted
method validation and concurrent recovery data were adequate.  Based on
the LLMV, the LOQ was 0.0102 ppm.  The study indicated that the
statistically determined LOQ and LOD were 0.1644 ppm and 0.0548 ppm,
respectively (standard deviation at LLMV multiplied by the one-tailed
99% t-stat).  However, HED found an error in the calculation and
recalculated the LOQ and LOD as 0.008 ppm and 0.003 ppm respectively
(calculation used a value of 0.102 ppm rather than 0.0102 ppm). 

860.1360 Multiresidue Methods

Spirodiclofen and BAJ 2510 were screened through the FDA MRM protocols. 
Since both spirodiclofen and BAJ 2510 are not N-methylcarbamates,
naturally fluorescent, acids, phenols, or substituted ureas, testing
through protocols A, B, and G is unnecessary.  Protocol C modules DG1
and DG10 gave acceptable results for BAJ 2510 and spirodiclofen,
respectively (both are GC/ECD systems).  Using fortified orange samples,
acceptable recoveries of spirodiclofen were attained through Protocols D
(80-103%) and E (54-77%).  Using fortified ground beef samples,
unacceptable recoveries of spirodiclofen were attained through protocol
F (16-30%).  BAJ 2510 was not recovered through the florisil clean-up
column, and therefore, gave unacceptable recoveries for Protocol D
(fortified orange samples) and F (fortified ground beef samples).  Since
BAJ 2510 was not recovered through Protocol D, Protocol E was not
tested.  These data have been forwarded to FDA (D308565, T. Bloem,
29-Sep-2004).

860.1380 Storage Stability

The blueberry samples from the field trials were stored frozen for up to
327 days prior to analysis. As part of the current study, the petitioner
submitted storage stability which indicate that residues of
spirodiclofen per se are stable in/on blueberry when stored frozen for
352 days.  HED notes that these data did not include a zero day analysis
as requested in the OPPTS 860.1380 guidelines. The petitioner previously
submitted storage stability data which indicated that residues of
spirodiclofen per se are stable when stored frozen for the following
crop/intervals (D285249, T. Bloem, 18-Apr-2005):  391 days (grape), 231
days (raisin), 226 days (grape juice concentrate), 231 days (apple juice
concentrate), 231 days (dried apple), 391 days (peaches), 306 days
(prunes), 410 days (almond nutmeat), and 305 days (almond hulls).  The
almond hull data indicated a 26% reduction in residues for samples
stored 410 days.  These data support the storage intervals and
conditions for the blueberry samples collected as part of the current
study.

860.1480 Meat, Milk, Poultry, and Eggs

Based on the revised Table 1 feedstuffs (OPPTS 860.1000), none of the
proposed crops have feed commodities; therefore a discussion concerning
the magnitude of the residue in livestock is unnecessary.  

860.1500 Crop Field Trials

47886201.der.doc

In support of the proposed registration, six lowbush (NAFTA growing
zones 1 (n=4) and 5 (n=2)) and six highbush (n=6; NAFTA growing zones 2
(n=3), 5 (n=1), and 12 (n=2)) blueberry field trials were submitted. 
Provided a revised Section B is submitted, the application scenario
employed in the field trials supports the proposed application scenario
and resulted in spirodiclofen per se residues in/on highbush and lowbush
blueberry of 0.362-1.069 ppm and  0.100-2.333 ppm, respectively (see
below for summary).  Based on these data, the Agency's tolerance
calculator recommended for highbush and lowbush blueberry tolerances for
residues of spirodiclofen per se of 1.4 ppm and 3.5 ppm, respectively
(see attachment 3).  

The representative commodity for the bushberry subgroup 13-07B is
highbush blueberry with lowbush blueberry included in the subgroup.  HED
notes that additional trials in zones 1 (n=1) and 5 (n=2) are needed to
fulfill the geographical distribution specified in OPPTS 860.1500 for
highbush blueberry.  Since the petitioner submitted six lowbush
blueberry field trials and the data for these trials indicates that
residues are higher in/on lowbush blueberry as compared to highbush
blueberry, HED concludes that additional data are unnecessary.  Based on
the submitted data, HED concludes that a tolerance of 3.5 ppm for
residues of spirodiclofen per se in/on the bushberry subgroup 13-07B is
appropriate.  A revised Section F is requested.  

Blueberry (47886201.der.wpd):  IR-4 submitted six lowbush blueberry
(NAFTA growing zones 1 (n=4) and 5 (n=2)) and six highbush blueberry
(NAFTA growing zones 2 (n=3), 5 (n=1), and 12 (n=2)) field trials
conducted during 2006.  Each trial consisted of one untreated plot and
one treated plot with the treated plots receiving a single
foliar-directed (highbush blueberry) or foliar-broadcast (lowbush
blueberry) application of spirodiclofen (SC; 2 lb ai/gal) at 0.271-0.307
lb ai/acre (19-66 GPA; no adjuvant).  Single control and duplicate
treated blueberry samples were harvested 6-8 days after application. 
Additional samples were collected at one of the highbush blueberry and
lowbush blueberry field trials at 1, 3, 10, and 14 days after
application.  

The harvested samples were analyzed for residues of spirodiclofen per se
using an adequately validated LC/MS/MS method (storage interval has also
been validated).  Residues of spirodiclofen per se in/on highbush
blueberry harvested 6-8 days after a single foliar-directed application
of spirodiclofen (SC) at 0.278-0.288 lb ai/acre were 0.362-1.069 ppm
(see Table 4).  Residues of spirodiclofen per se in/on lowbush blueberry
harvested 6-7 days after a single broadcast-foliar application of
spirodiclofen (SC) at 0.271-0.307 lb ai/acre were 0.100-2.333 ppm (see
Table 4).  The highbush blueberry and lowbush blueberry residue decline
data indicate that residue of spirodiclofen per se declined as the PHI
increased from 1 to 14 days.  

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

Commodity	Total App. Rate 

(lb ai/acre)	PHI (days)	Residue Levels  (ppm)1

	n	Min.	Max.	HAFT2	Median	Mean	Std. Dev.

Highbush blueberry	0.278-0.288	6-8	12	0.362	1.069	1.054	0.551	0.621
0.237

Lowbush blueberry	0.271-0.307	6-7	12	0.100	2.333	2.296	1.282	1.305	0.624

1  Based on the LLMV, the LOQ = 0.01 ppm.

2  HAFT = highest-average field trial.

860.1520 Processed Food and Feed

Based on Table 1 of OPPTS 860.1000, there are not processed commodities
associated with the proposed crops.  

860.1850/860.1900 Confined and Field Accumulation in Rotational Crops

Since all of the requested crops are perennials, a discussion concerning
the nature/magnitude of the residue in rotational crops is unnecessary. 
 

860.1550 Proposed/Recommended Tolerances

Table 5 is a summary of the proposed and recommended tolerance for
residues of spirodiclofen per se.  There are no Canadian maximum residue
limits (MRLs) in/on the requested crops.  Codex does have a MRL for
residues of spirodiclofen per se in/on black/red currant at 1 ppm; since
the Codex tolerance is lower than the maximum residues form the
submitted field trials, harmonization is not possible.   

In accordance with the most recent guidance concerning tolerance
expressions, HED recommends that the tolerance expression for
180.608(a)(1) and 180.6(a)(2) be changed as indicated below.  HED notes
that this alteration in the tolerance expression does not necessitate a
change in the currently established or recommended tolerance levels.  A
revised Section F specifying the new tolerance expression, the currently
established commodity/tolerance levels, and the HED-recommended
bushberry subgroup 13-07B tolerance should be submitted.  

180.608(a)(1):  Tolerances are established for residues of
spirodiclofen, including its metabolites and degradates, in or on the
commodities listed below.  Compliance with the following tolerance
levels is to be determined by measuring only spirodiclofen
(3-(2,4-dichlorophenyl)-2-oxo-1-oxaspiro[4.5]dec-3-en-4-yl
2,2-dimethylbutanoate.

180.608(a)(2):  Tolerances are established for residues of
spirodiclofen, including its metabolites and degradates, in or on the
commodities listed below.  Compliance with the following tolerance
levels is to be determined by measuring only spirodiclofen
(3-(2,4-dichlorophenyl)-2-oxo-1-oxaspiro[4.5]dec-3-en-4-yl
2,2-dimethylbutanoate) and its metabolite
3-(2,4-dichlorophenyl)-4-hydroxy-1-oxaspiro[4,5] dec-3-en-2-one.

Table 5:  Tolerance Summary.

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

Bushberry subgroup 13-07B	4.0	3.5	A revised Section F, specifying the
correct tolerance value and tolerance expression is requested.

Attachment 1:  Chemical Structures

Attachment 2:  Codex

Attachment 3:  Tolerance Calculation

  SEQ CHAPTER \h \r 1 RDI: RAB1 Chemists (16-June-2010)

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

Attachment 1:  Chemical Structures

Chemical Name	Structure

Spirodiclofen; BAJ2740

3-(2,4-dichlorophenyl)-2-oxo-1-oxaspiro[4,5]dec-3-en-4-yl
2,2-dimethylbutanoate	

BAJ 2510

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Attachment 2:  International residue Limit Status

INTERNATIONAL RESIDUE LIMIT STATUS

Chemical Name: 

3-(2,4-dichlorophenyl)-2-oxo-1-oxaspiro[4,5]dec-3-en-4-yl
2,2-dimethylbutanoate	Common Name:

spirodiclofen	X Proposed tolerance

( Reevaluated tolerance

( Other - HED recommended tolerances	Date: 4-May-2010

Codex Status (Maximum Residue Limits)	U. S. Tolerances

(No Codex proposal step 6 or above

(No Codex proposal step 6 or above for the crops requested	Petition
Number:  9E7632

DP Number:  371469

Other Identifier:

Residue definition: spirodiclofen	Reviewer/Branch: Tom Bloem/RAB1

	Residue definition:  spirodiclofen

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

Currants, black, red, white	1	bushberry subgroup 13-07B	4.0

Limits for Canada	Limits for Mexico

(  No Limits

√  No Limits for the crops requested	(   No Limits (no information
after 2004)

(   No Limits for the crops requested

Residue definition: 3-(2,4-
dichlorophenyl)-2-oxo-1-oxaspiro[4.5]dec-3-en-4-yl
2,2-dimethylbutanoate.	Residue definition: Mexico adopts Codex and/or US
MRLs/tolerances for its export purposes.

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

	Notes/Special Instructions: S.Funk, M. Negussie/05/06/2010

Attachment 3:  Tolerance Calculation

Spirodiclofen	Summary of Analytical Chemistry and Residue Data	D371643

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