Document ID: EPA-HQ-OPP-2009-0139-0006
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2010-05-05T04:00Z

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, D.C.  20460

OFFICE OF           

PREVENTION, PESTICIDES

AND TOXIC SUBSTANCES

MEMORANDUM

Date:		23-September-2009

Subject:	Spirodiclofen in/on Avocado, Black Sapote, Canistel, Mamey
Sapote, Mango, Papaya, Sapodilla, and Star Apple.  Summary of Analytical
Chemistry and Residue Data.

PC Code:  124871	DP Barcode:  D363343

Decision No.:  404221	Registration No.:  264-831

Petition No.:  8F7500	Regulatory Action:  Section 3 

Risk Assessment Type:  not applicable	Case No.:  none

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

MRID Nos:  47630101	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:		John Hebert/Rita Kumar (RM 07)

		Registration Division (RD; 7505P) 

Bayer CropScience (Research Triangle Park, NC) proposed the
establishment of permanent tolerances for residues 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) in/on the
following commodities:

avocado	1.3 ppm

black sapote	1.3 ppm

canistel	1.3 ppm

mamey sapote	1.3 ppm

mango	1.3 ppm

papaya	1.3 ppm

sapodilla	1.3 ppm

star apple	1.3 ppm

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, 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
avocado, black sapote, canistel, mamey sapote, mango, papaya, sapodilla,
and star apple (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

Avocado, Black Sapote, Canistel, Mamey Sapote, Mango, Papaya, Sapodilla,
and Star Apple

foliar spray	0.28-0.31	1	2	●Excluding avocado, applications may be
made with ground equipment only (minimum spray volume of 50 gallons per
acre (GPA)); for avocado, the label states that ground (minimum spray
volume of 50 GPA) or aerial (minimum spray volume of 100 GPA)
application equipment may be used.

●Maximum seasonal application rate - 0.31 lb ai/acre.

●Label states the following pests are controlled - Avocado brown mite,
Avocado red mite, Broad mite, Carmine spider mite, Citrus red mite, Flat
mite (black and red), Mango spider mite, Papaya Leaf edgeroller mite,
Persea mite, Sixspotted mite, Texas citrus mite, and Twospotted spider
mite.

1  PHI = preharvest interval.

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
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 determined that these conclusions may be translated to the currently
requested crops.  Therefore, the residues of concern in the currently
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 the free enol metabolite (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 - Plants:  In support of the proposed
registration, five avocado field trials, conducted during 2007 and 2008
in the North American Free Trade Agreement (NAFTA) zones 3 (n=1) and 10
(n=4), 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
avocado fruit of <0.01-0.614 ppm (method and storage intervals were
adequately validated).  The geographical representation of the field
trial data conform to the data requirements specified in OPPTS 860.1500
for avocado.  Based on the avocado field trial data and the tolerance
calculator, HED concludes that an avocado tolerance of 1.0 ppm, for
residues of spirodiclofen per se, is appropriate.  Based on guidance
from the HED Chemistry Science Advisory Council (ChemSAC), HED will
translate the avocado field trial data to black sapote, canistel, mamey
sapote, mango, papaya, sapodilla, and star apple (Reviewer’s Guide and
Summary of HED ChemSAC Approvals for Amending Commodity Definitions
[40CFR § 180.1(h)] and Crop Group/Subgroups [40 CFR § 180.41]; B.
Schneider; 14-Jun-2002).  Therefore, the avocado residue data supports a
tolerance of 1.0 ppm for residues of spirodiclofen per se in/on black
sapote, canistel, mamey sapote, mango, papaya, sapodilla, and star
apple.  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 data collection method and the
tolerance enforcement method and since the tolerance enforcement method
has been validated on a fruit crop, HED concludes that the current
enforcement method is appropriate for enforcement of the tolerances
recommended as part of this petition.FDA Multiresidue Methods: 
Spirodiclofen and BAJ 2510 were screened through the FDA Multiresidue
Methods (MRM) protocols.  The petitioner indicated that since both
spirodiclofen and BAJ 2510 are not N-methylcarbamates, naturally
fluorescent, acids, phenols, or substituted ureas, Protocols A, B, and G
were not performed.  Therefore, testing was only performed for protocols
C, D, E, and F.

Protocol C modules DG1 and DG10 gave acceptable results for BAJ 2510 and
spirodiclofen, respectively (both are gas chromatograph/electron-capture
detection (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 the petitioner submits revised Sections B and
F, HED concludes that the residue chemistry database supports an
unconditional registration and establishment of the following permanent
tolerances for residues of spirodiclofen per se:  Avocado - 1.0 ppm,
Black sapote - 1.0 ppm, Canistel - 1.0 ppm, Mamey sapote - 1.0 ppm,
Mango - 1.0 ppm, Papaya - 1.0 ppm, Sapodilla - 1.0 ppm, and Star apple -
1.0 ppm.  

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, 

0μg/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 (2 lbs ai/gallon; EPA Reg. No. 264-831) to
avocado, black sapote, canistel, mamey sapote, mango, papaya, sapodilla,
and star apple. (see Table 1 for summary).  Application through
irrigation equipment and in enclosed structures is prohibited.  Although
the label does not indicate that adjuvants (crop oil concentrate,
nonionicsurfactant, 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 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 has determined that these conclusions may be translated to the
currently requested crops.  Therefore, the residues of concern in the
currently 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 the free enol metabolite (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% 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).

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

Data Collection:  The avocado field trial samples were analyzed for
residues of spirodiclfen per se using a liquid chromatograph/mass
spectrometer/mass spectrometer (LC/MS/MS) method.  Briefly, pitted
homogenized samples were extracted by blending with acetonitrile
(ACN):water (2:1; v:v) containing a small amount of aqueous 20% cysteine
hydrochloride.  Isotopically labeled internal standard were added and
the extracts were centrifuged, filtered through a nylon syringe filter,
and analyzed via LC/MS/MS.  Acceptable concurrent recoveries were
attained for samples fortified with spirodiclofen at 0.01-1.0 ppm
(93-116%).  Based on these acceptable recoveries and since the
extraction solvent employed in the data collection method is identical
to that employed in the tolerance enforcement method (see below), HED
concludes that method is acceptable for data collection purposes.  Based
on the lower limit of method validation (LLMV), the limit of
quantitation (LOQ) is 0.01 ppm.  The statistically determined limit of
detection (LOD) is 0.0017 ppm (standard deviation at 0.01 ppm multiplied
by the one-tailed 99% t-stat).  

Tolerance Enforcement:  HED forwarded Bayer analytical method 109351 to
FDA for inclusion in the PAM (D368434, T. Bloem, 23-Sep-2009).  Briefly,
the fruit samples were extracted with ACN:water (2:1; v:v) containing a
small amount of aqueous 20% cysteine hydrochloride, filtered, and an
aliquot of the filtrate was acidified with HCl.  The extracted residues
were subjected to clean up on an ENVI-carb cartridge preconditioned with
dichloromethane (DCM), methanol, and water with residues eluted out with
DCM under vacuum.  The eluted residues were 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 data collection method and the tolerance enforcement
method and since the tolerance enforcement method has been validated on
a fruit crop, HED concludes that the current enforcement method is
appropriate for enforcement of the tolerances recommended as part of the
this petition.  

860.1360 Multiresidue Methods

Spirodiclofen and BAJ 2510 were screened through the FDA MRM protocols. 
The petitioner indicated that since both spirodiclofen and BAJ 2510 are
not N-methylcarbamates, naturally fluorescent, acids, phenols, or
substituted ureas, Protocols A, B, and G were not performed.  Therefore,
testing was only performed for protocols C, D, E, and F.

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 avocado fruit samples from the field trials were stored frozen for
up to 282 days prior to analysis.  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 avocado
fruit 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

47630101.der.doc

In support of the proposed registration, five avocado field trials,
conducted during 2007 and 2008 in NAFTA zones 3 (n=1) and 10 (n=4), were
submitted (47630101.der.doc; see below).  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 avocado fruit of <0.01-0.614 ppm (method and
storage intervals were adequately vlaidated).  The geographical
representation of the field trial data conform to the data requirements
specified in OPPTS 860.1500 for avocado.  Based on the avocado field
trial data and the tolerance calculator, HED concludes that an avocado
tolerance of 1.0 ppm, for residues of spirodiclofen per se, is
appropriate (see attachment 3).  Based on guidance from the HED ChemSAC,
HED will translate the avocado field trial data to black sapote,
canistel, mamey sapote, mango, papaya, sapodilla, and star apple
(Reviewer’s Guide and Summary …..; B. Schneider; 14-Jun-2002). 
Therefore, the avocado residue data supports a tolerance of 1.0 ppm for
residues of spirodiclofen per se in/on black sapote, canistel, mamey
sapote, mango, papaya, sapodilla, and star apple.  A revised Section F
is requested.  

Avocado (47630101.der.wpd):  Bayer CropScience submitted residue data
for five avocado trials conducted during 2007 and 2008 in the North
American Free Trade Agreement (NAFTA) zones 3 (n=1) and 10 (n=4).  Each
trial consisted of one untreated plot and two treated plots.  The
treated plots received a single foliar broadcast application of a 2 lb
ai/gallon spirodiclofen SC formulation at 0.309-0.328 lb ai/acre.  The
treated plots differed in that one employed a dilute spray volume
(218-363 GPA) and the other employed and a concentrate spray volume
(46-70 GPA).  Applications were made using ground equipment and did not
include the use of any spray adjuvants.  Duplicate control and treated
avocado fruit samples were collected from each trial 2 days after
treatment.  Additional samples were collected at two of the field trials
0, 5, 7, and 10 days after application.  

The LC/MS/MS method used to determine residues of spirodiclofen per se
in avocado was adequately validated in conjunction with the analysis of
field trial samples.  Based on the LLMV, the LOQ is 0.01 ppm (residues
in controls <LOQ).  The statistically determined limit of detection
(LOD) is 0.0017 ppm (standard deviation at 0.01 ppm multiplied by the
one-tailed 99% t-stat).  The storage intervlas were also validated.  

Following a single foliar application of spirodiclofen (SC) at
0.309-0.328 lb ai/acre, residues of spirodiclofen per se were
<0.01-0.614 ppm (dilute/concrete spray volumes; see Table 4).  A paired
t-test (two-tailed) analysis of the side-by-side field trials indicates
that spirodiclofen residues were not influenced by spray volume (dilute
(218-363 GPA) -vs- concentrate (46-70 GPA)).  The residue decline data
indicate that residue of spirodiclofen per se declined as the PHI
increased from 0 to 10 days.  

Table 4:  Summary of Avocado Residue Data.

Commodity	Total App. Rate 

(lb ai/A); Spray Vol.	PHI (days)	Residue Levels  (ppm)1

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

Avocado	0.309-0.328; conc.	2	10	<0.01	0.614	0.474	0.063	0.134	0.195

	0.312-0.322; dilute	2	10	0.015	0.204	0.192	0.085	0.094	0.063

	0.309-0.328; both conc. and dilute	2	20	<0.01	0.614	0.474	0.070	0.110
0.143

1  Based on the LLMV, the LOQ = 0.01 ppm; LOD = 0.0017 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 tolerances for
residues of spirodiclofen per se.  A revised Section F should be
submitted.  There are no Codex, Canadian, or Mexican maximum residue
limits (MRLs) in/on the requested crops.  Therefore, harmonization is
not an issue for this registration.  

Table 5:  Tolerance Summary.

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

Avocado	1.3	1.0	A revised Section F, specifying the correct tolerance
value, is requested.

Black Sapote	1.3	1.0

	Canistel	1.3	1.0

	Mamey Sapote	1.3	1.0

	Mango	1.3	1.0

	Papaya	1.3	1.0

	Sapodilla	1.3	1.0

	Star Apple	1.3	1.0

	

Attachment 1:  Chemical Structures

Attachment 2:  Codex

Attachment 3:  Tolerance Calculation

  SEQ CHAPTER \h \r 1 RDI: RAB1 Chemists (29-July-2009)

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

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Chemical Structures

Chemical Name	Structure

Spirodiclofen; BAJ2740

BAJ 2510

 

3-OH-enol

 

4-OH-enol

 

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

	( Proposed tolerance

( Reevaluated tolerance

X Other - HED recommended tolerances	Date: 23-Jul-2009

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:  8F7500

DP Number:  363343

Other Identifier:

Residue definition:  N/A	Reviewer/Branch: Tom Bloem/RAB1

	Residue definition:  spirodicl0fen

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

Avocado	1.0

Black Sapote	1.0

Canistel	1.0

Mamey Sapote	1.0

Mango	1.0

Papaya	1.0

Sapodilla	1.0

Star Apple	1.0

Limits for Canada	Limits for Mexico

(  No Limits

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

$

  hOi

.5]dec-3-en-2-one, 3-(2,4-dichlorophenyl)-4-hydroxy-(9CI)	Residue
definition:  N/A

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

Notes/Special Instructions: S.Funk, 07/27/2009.

Attachment 3:  Tolerance Calculation

Spirodiclofen	Summary of Analytical Chemistry and Residue Data	D363343

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