Document ID: EPA-HQ-OPP-2007-0331-0006
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2008-03-12T04:00Z

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, D.C.  20460

OFFICE OF           

PREVENTION, PESTICIDES

AND TOXIC SUBSTANCES

MEMORANDUM

	Date:	05/DEC/2007

	Subject:	Spiromesifen.  Petition for the Establishment of Permanent
Tolerances on Beans (Dry Shelled, Succulent Shelled, and Edible Podded)
and Cowpea Forage and Reassessment of Existing Tolerances on Livestock
Commodities - PP#7E7195.  Summary of Analytical Chemistry and Residue
Data.

DP Number:	345985	Decision Number:	377056

PC Code:	024875	MRID No.:	47083501

40 CFR 180.	607

Chemical Class:	Insecticide/Miticide

      From:	Debra Rate, Ph.D., Biologist

Alternative Risk Integration and Assessment (ARIA) Team

Risk Integration, Minor Use and Emergency Response Branch (RIMUERB)

	Registration Division (RD) (7505P)

	Through:	William Cutchin, Acting Senior Branch Scientist

		ARIA

		RIMUERB/RD (7505P)

		

		George Kramer, Branch Senior Chemist

		Registration Action Branch 1 (RAB1)

		Health Effects Division (HED) (7509P)

	To:	Breann Hanson, Biologist

		ARIA

		RIMUERB/RD (7505P)

  SEQ CHAPTER \h \r 1 This document was originally prepared under
contract by Dynamac Corporation (submitted 30/AUG/2007).  The DER has
been reviewed by ARIA of the Registration Division (RD) and revised to
reflect current Office of Pesticide Programs (OPP) policies.

Executive Summary

Spiromesifen is a tetronic acid insecticide/miticide used for control of
a broad spectrum of mite pests and whiteflies in corn, cotton,
strawberries, and various vegetable crops.  Spiromesifen acts as a lipid
biosynthesis inhibitor by blocking the proper synthesis of fatty acids
and their biochemical derivatives.

The Interregional Research Project No. 4 (IR-4), on behalf of the
Agricultural Experiment Stations of CA, DE, GA, ID, NC, and TX, proposes
to amend the product label for Oberon® 2SC Insecticide/Miticide (EPA
Reg. No. 264-719) to include new uses of spiromesifin on beans (dry
shelled, succulent shelled, and edible podded).  Oberon® 2SC is a
suspension concentrate (SC; equivalent to a flowable concentrate; FlC)
formulation containing 23.1% active ingredient (2 lb ai/gal).  It is
proposed for use on beans at a maximum of three foliar applications,
with a minimum retreatment interval of 7 days, for a total seasonal rate
of 0.57 lb ai/A.  The proposed preharvest intervals (PHI) are 1 day for
succulent shelled and edible podded beans and 10 days for dry shelled
beans.

In conjunction with the proposed new use, IR-4 has proposed (PP#7E7195)
the establishment of permanent tolerances for the combined residues of
spiromesifen
(2-oxo-3-(2,4,6-trimethylphenyl)-1-oxaspiro[4.4]non-3-en-4-yl
3,3-dimethylbutanoate) and its enol metabolite
(4-hydroxy-3-(2,4,6-trimethylphenyl)-1-oxaspiro[4.4]non-3-en-2-one),
calculated as the parent compound equivalents, in/on the following raw
agricultural commodities (RACs):

	Bean, dry	0.02 ppm

	Bean, succulent	0.10 ppm

	Bean, edible podded	1.4 ppm

	Cowpea, forage	35 ppm

In addition, to account for the potential increase in dietary exposure
resulting from the proposed tolerance on cowpea forage which is a
livestock feedstuff, IR-4 has proposed the establishment of permanent
tolerances for the combined residues spiromesifen and its metabolites
containing the enol
(4-hydroxy-3-(2,4,6-trimethylphenyl)-1-oxaspiro[4.4]non-3-en-2-one] and
4-hydroxymethyl
(4-hydroxy-3-[4-(hydroxymethyl)-2,6-dimethylphenyl]-1-oxaspiro[4.4]non-3
-en-2-one) moieties, calculated as the parent compound equivalents,
in/on the following livestock commodities:

	Cattle, fat	0.20 ppm

	Cattle, meat	0.01 ppm

	Cattle, meat byproducts	0.30 ppm

	Goat, fat	0.20 ppm

	Goat, meat	0.01 ppm

	Goat, meat byproducts	0.30 ppm

	Hog, fat	0.20 ppm

	Hog, meat	0.01 ppm

	Hog, meat byproducts	0.30 ppm

	Horse, fat	0.20 ppm

	Horse, meat	0.01 ppm

	Horse, meat byproducts	0.30 ppm

	Milk	0.01 ppm

	Sheep, fat	0.20 ppm

	Sheep, meat	0.01 ppm

	Sheep, meat byproducts	0.30 ppm

Tolerances have been established under 40CFR§180.607(a)(1) for the
combined residues of spiromesifen and its enol metabolite, calculated as
the parent compound equivalents, in/on primary crop commodities
including field corn, cotton, strawberry, and various vegetable
commodities.  The established tolerances for primary crop commodities
range from 0.02 ppm (field corn grain and tuberous and corm vegetables,
subgroup 1C) to 15 ppm (cotton gin byproducts).  Tolerances have been
established under 40 CFR §180.607(a)(2) for the combined residues of
spiromesifen and its metabolites containing the enol and 4-hydroxymethyl
(4-hydroxy-3-[4-(hydroxymethyl)-2,6-dimethylphenyl]-1-oxaspiro[4.4]non-3
-en-2-one) moieties, expressed as parent equivalents, at 0.05 ppm in the
fat and meat byproducts of cattle, goat, horse, and sheep, and at 0.10
ppm in milk fat.  Under 40 CFR §180.607(d), tolerances for the
inadvertent or indirect combined residues of spiromesifen, its enol
metabolite, and its metabolites containing the 4-hydroxymethyl moiety,
calculated as the parent compound equivalents, have been established
in/on rotational crops alfalfa, barley, sugar beet, oat, and wheat
commodities at 0.03-3.0 ppm.

The nature of the residue in plant commodities is adequately understood
based on acceptable metabolism studies conducted on lettuce, cotton,
tomato, and confined rotational crops.  The metabolic pathways in all
RACs are very similar.  Spiromesifen is metabolized by the loss of the
dimethylbutyric acid group to yield BSN 2060-enol followed by
hydroxylation and conjugation.  The reviewed studies also indicate that
spiromesifen, when foliarly applied during the vegetative growth stage,
is not readily translocated.  Residues in crops with late-season
applications are mostly on the surface.  Spiromesifen and BSN 2060-enol
are the residues of concern in crops for purposes of tolerance
enforcement and risk assessment.  Additionally, BSN 2060-4-hydroxymethyl
(free and conjugated) is a residue of concern in leafy vegetables (risk
assessment only) and rotational crops (tolerance enforcement and risk
assessment). 

The nature of the residue in livestock commodities is adequately
understood based on metabolism studies conducted with lactating goats
and laying hens.  Based on these studies, spiromesifen is metabolized by
the loss of the dimethylbutyric acid group to yield BSN 2060-enol. 
Further metabolism can include hydroxylation of BSN 2060-enol to yield
BSN 2060-2-hydroxymethyl or BSN 2060-4-hydroxymethyl; hydroxylation of
BSN 2060-enol to yield BSN 2060-3-pentanol; oxidation of BSN
2060-3-pentanol or BSN 2060-2- or -4-hydroxymethyl to give BSN 2060-2-
or -4-hydroxymethyl-3-pentanol; oxidation of BSN 2060-4-hydroxymethyl to
give BSN 2060-pentanone or BSN 2060-4-aldehyde; oxidation of BSN 2060-2-
or 4-hydroxymethyl-3-pentanol to give BSN 2060-hydroxy-4-carboxy; and
further hydroxylation of BSN 2060-4-hydroxymethyl-3-pentanol or BSN
2060-hydroxy-4-carboxy to give BSN 2060-dihydroxy-4-carboxy. 
Spiromesifen and BSN 2060-enol are the residues of concern in livestock
for purposes of tolerance enforcement and risk assessment. 
Additionally, BSN 2060-4-hydroxymethyl (free and conjugated) is a
residue of concern in ruminant commodities (tolerance enforcement and
risk assessment).

A high-performance liquid chromatography (HPLC)/mass-spectrometry
(MS/MS) method (Method 00631/M001) was submitted previously for the
enforcement of tolerances for residues of spiromesifen, BSN 2060-enol,
and BSN 2060 4-hydroxymethyl in/on plant commodities.  The previously
validated limit of quantitation (LOQ) is 0.01 ppm for each analyte.  The
proposed enforcement methodology was submitted for a petition method
validation (PMV) by the Analytical Chemistry Laboratory/Biological and
Economics Analysis Division (ACL/BEAD).  The proposed method was
evaluated and accepted with recommendations (DP Num: 305721,
15/NOV/2007, E. Kolbe).  Samples of beans (dry shelled, succulent
shelled, and edible podded) from the crop field trials submitted in
support of this petition were analyzed for residues of spiromesifen and
BSN 2060-enol using a variation of Method 00631/M001.  The concurrent
method recoveries demonstrated that the method is adequate for data
collection.  The lowest level of method validation (LLMV) for this
method for each spiromesifen and BSN 2060-enol was 0.01 ppm for dry
shelled bean seed and 0.05 ppm for succulent shelled bean seed, edible
podded bean, and bean foliage.  Liquid chromatography (LC)/MS/MS Method
110878 was also submitted for determination of spiromesifin residues of
concern in livestock tissues and milk.  Validation data, including
independent laboratory validation and radiovalidation studies have been
submitted.  Method 110878 has been evaluated by ACL/BEAD for a PMV and
accepted with recommendations (DP Num: 305721, 15/NOV/2007, E. Kolbe).

Adequate multiresidue method data for spiromesifen, BSN 2060-enol, and
BSN 2060 4-hydroxymethyl were previously submitted.  Spiromesifen was
completely recovered using multiresidue method Protocols D, E and F, for
the analysis of nonoily and fatty commodities.  The methods were not
found to be suitable for the determination of BSN 2060-enol and BSN 2060
4-hydroxymethyl. Thus, the MRM are not adequate for enforcement of
tolerances which include residues of spiromesifen and BSN 2060-enol.

There are adequate storage stability data to support the storage
conditions and durations of samples collected from the bean field
trials.  There are no storage stability issues or corrections that may
need to be applied to the submitted residue studies on beans.

An adequate cattle feeding study is available to support the livestock
dietary burdens resulting from the proposed uses.  Dietary burdens of
~22 ppm were calculated for beef and dairy cattle, and ~0.3 ppm for
poultry, and ~0.04 ppm for swine.  The calculations reflect the most
recent guidance from HED concerning revisions of feedstuff percentages
in OPPTS 860.1000 Table 1 (October 2006) and constructing reasonably
balanced livestock diets.  Based on these dietary exposure levels and
the residue data from the ruminant feeding study, the data indicate that
a tolerance (0.02 ppm) is needed in the meat of cattle, goats, horses,
and sheep; a tolerance increase (0.15 ppm) is required for meat
byproducts of cattle, goats, horses, and sheep; a tolerance increase
(0.10 ppm) is required for the fat of cattle, goats, horses and sheep; a
tolerance increase (0.20 ppm) for milk, fat and a tolerance for milk
(0.01 ppm).  Based on the transfer coefficients for livestock tissues
and the relatively low dietary burden for swine, spiromesifen tolerances
in hogs are not required.  A revised Section F will be required to
request the tolerance increase for milk, fat and to adjust the proposed
tolerance levels to match the recommended tolerances (Table 10).  

Based on a dietary burden of 0.3 ppm for poultry and the residues
identified in the poultry metabolism study, the proposed use of
spiromesifen on cowpea addressed in this document is not expected to
alter the Agency’s previous determination that there is no reasonable
expectation of finite residues [40CFR§180.6(a)(3)] in poultry
commodities, and therefore, no tolerances are needed in poultry and
eggs.  If in the future, the petitioner proposes a use which increases
the dietary burdens of poultry, then the Category 3 situation will be
re-evaluated. 

The submitted field trial data for dry shelled, succulent shelled and
edible-podded beans are adequate.  There is sufficient geographic
representation of residue data, and the field trials were conducted
according to the proposed use pattern for Oberon® 2SC
Insecticide/Miticide (EPA Reg. No. 264-719).  Residues for dry bean and
succulent bean were all below the combined LLMV for both the parent and
metabolite; therefore, the recommended tolerances are 0.02 ppm in bean,
dry and 0.10 ppm in bean, succulent.  Recommended tolerances for bean,
edible podded and cowpea forage were calculated using the maximum
residue limit (MRL)/maximum likelihood estimation (MLE) tolerance
spreadsheets.  The calculated tolerances for bean, edible podded and
cowpea, forage are 0.80 ppm and 30 ppm, respectively.  A revised Section
F must be submitted to change the requested tolerance in bean, edible
podded to 0.80 ppm, and the requested tolerance in cowpea, forage to 30
ppm.

The submitted data for succulent shelled bean foliage was used to
establish a tolerance in cowpea forage.  However, no residue data were
submitted for cowpea hay.  For the purpose of this petition, ARIA will
recommend a tolerance for cowpea hay calculated from the recommended
tolerance for cowpea forage and adjusting for percentages of dry matter
between cowpea hay and cowpea forage.  A revised Section F must be
submitted for the addition of cowpea, hay at a level of 86 ppm.  If the
petitioner does not agree with the magnitude of the recommended
tolerance for cowpea, hay, residue data for cowpea, hay would need to be
submitted.  A minimum of three trials are required. These trials must be
conducted in EPA growing Regions 2 (1 trial), 4 (1 trial), and 6 (1
trial) as per Table 5 of OPPTS 860.1500.

There are adequate field rotational crop data to support the established
tolerances for the inadvertant or indirect combined residues of
spiromesifen, its enol metabolite, and its metabolites containing the
4-hydroxymethyl moiety in/on the rotational crop commodities of alfalfa,
barley, sugar beet, oat, and wheat.  The proposed rotational crop
restrictions (a 30-day plantback interval (PBI) for alfalfa, barley,
oat, sugar beets, and wheat; and a 12-month PBI for all other crops) are
consistent with what were previously deemed acceptable and are supported
by adequate data.

Analytical standards for spiromesifen and one metabolite, spiromesifen
glycol are currently available in the EPA National Pesticide Standards
Repository.  In addition, very small amounts of deuterated standards of
the parent and other metabolites that are used for internal standards
for a specific MS analysis that was submitted by the registrant are
available.

No Codex, Canadian, or Mexican maximum residue limits (MRLs) have been
established for residues of spiromesifen and its metabolites.

  SEQ CHAPTER \h \r 1 Regulatory Recommendations and Residue Chemistry
Deficiencies

Pending the submission of a revised Section F and resolution of data
gaps specified below, there are no residue chemistry issues that would
preclude granting a registration for the requested uses of spiromesifin
on beans (dry shelled, succulent shelled, and edible podded).  The
proposed uses and the submitted and/or translated data support the
following tolerances for the combined residues of spiromesifen and its
enol metabolite (BSN 2060-enol), calculated as parent compound
equivalents, in/on the following primary crop commodities:

	Bean, dry	0.02 ppm

	Bean, succulent	0.10 ppm

	Bean, edible podded	0.80 ppm

	Cowpea, forage	30 ppm

	Cowpea, hay	86 ppm

The proposed uses and the submitted data support the following
tolerances for the combined residues of spiromesifen and its metabolites
BSN 2060-enol and BSN 2060-4-hydroxymethyl (free and conjugated),
calculated as parent compound equivalents, in the following animal
commodities:

	Cattle, fat	0.10 ppm

	Cattle, meat	0.02 ppm

	Cattle, meat byproducts	0.15 ppm

	Goat, fat	0.10 ppm

	Goat, meat	0.02 ppm

	Goat, meat byproducts	0.15 ppm

	Horse, fat	0.10 ppm

	Horse, meat	0.02 ppm

	Horse, meat byproducts	0.15 ppm

	Sheep, fat	0.10 ppm

	Sheep, meat	0.02 ppm

	Sheep, meat byproducts	0.15 ppm

	Milk	0.01 ppm

	Milk, fat	0.20 ppm

A list of the residue chemistry deficiencies is presented below.

860.1340 Residue Analytical Methods

The petitioner should submit revised methods of enforcement to the
Agency, incorporating the recommendations by the analytical chemistry
branch (ACB)(DP Num: 305721, 15/NOV/2007, E. Kolbe).

860.1550 Proposed Tolerances

The petitioner should submit a revised Section F reflecting the
recommended tolerances and commodity definitions presented in Table 10.

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

Background

The chemical structure and nomenclature of spiromesifen and its enol
metabolite are presented in Table 1.  The physicochemical properties of
the technical grade of spiromesifen are presented in Table 2.

Table 1.	   Spiromesifen Nomenclature.

Chemical structure	

Common name	Spiromesifen

Company experimental name	BSN 2060

IUPAC name	3-mesityl-2-oxo-1-oxaspiro[4.4]non-3-en-4-yl
3,3-dimethylbutyrate

CAS name	2-oxo-3-(2,4,6-trimethylphenyl)-1-oxaspiro[4.4]non-3-en-4-yl
3,3-dimethylbutanoate

CAS registry number	283594-90-1

End-use product (EP)	2 lb/gal FlC formulation (Oberon® 2SC; EPA Reg.
No. 264-719)

Chemical structure of BSN 2060-enol metabolite	

4-hydroxy-3-(2,4,6-trimethylphenyl)-1-oxaspiro[4.4]non-3-en-2-one

Chemical structure of BSN 2060-4-hydroxymethyl metabolite	

4-hydroxy-3-[4-(hydroxymethyl)-2,6-dimethylphenyl]-1-oxaspiro[4.4]non-3-
en-2-one

Table 2.	Physicochemical Properties of Spiromesifen.

Parameter	Value	Reference

Melting point/range	96.7 - 98.7°C	DPNum: 298191, 4/29/04, S. Malak;
MRID 45854501

pH	5.19 (2% suspension in 0.1% NaCl)

	Density	1.13 g/mL

	Water solubility (20°C)	0.13 mg/L (constant from pH 4 to pH 9)

	Solvent solubility (20°C)	Acetone: >250 g/L 

Acetonitrile: >250 g/L 

Ethyl Acetate: >250 g/L 

Dichloromethane: >250 g/L 

n-Heptane: 23 g/L

1-Octanol: 60 g/L

2-Propanol: 110 g/L

Xylene: >250 g/L

	Vapor pressure at 25°C	1 x 10-5 Pa

	Dissociation constant, pKa	No acid or base properties between pH 2 and
pH 12

	Octanol/water partition coefficient, Log(KOW)	4.55 at 20°C

	UV/visible absorption spectrum	Molar absorption coefficient 23,360
L/mol cm at 214 nm (neutral)

	

Directions for Use

IR-4 has submitted a copy of the proposed use directions for the 2
lb/gal FlC formulation of spiromesifen (Oberon® 2SC; EPA Reg. No.
264-719) on beans.  The proposed use directions are presented in Table 3
below.  

Table 3.  Summary of Directions for Use of Spiromesifen.

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)

Succulent Shelled, Edible-Podded, and Dry Shelled Beans

[Lupinus spp., includes grain lupin, sweet lupin, white lupin, and white
sweet lupin;

Haseolus spp., includes field bean, kidney bean, lima bean, navy bean,
pinto bean, runner bean, snap bean, tepary bean, wax bean;

Vigna spp., includes adzuki bean, asparagus bean, blackeyed pea,
catjang, Chinese longbean, cowpea, Crowder pea, moth bean, mung bean,
rice bean, southern pea, urd bean, yardlong bean, broad bean (fava),
chickpea (garbanzo bean), guar, jackbean, lablab bean (hyacinth bean),
lentil, soybean (immature seed), sword bean]

Foliar spray

Ground or aerial	2 lb/gal FlC

[264-719]	0.11-0.19	3

(implied)	0.57	1 (for succulent and edible-podded beans)

10 (for dry shelled beans)

	Use Directions and Limitations:  Good coverage of the foliage is
necessary for optimal control; an adjuvant may be used.  A minimum 7-day
RTI is specified.  Applications may be made in a minimum of 10 gal/A
using ground equipment and 5 gal/A using aerial equipment.  Forage from
treated crops may be used for animal consumption.

The following rotational crop restrictions are specified:  (i) immediate
(0 day) PBI for cotton, field corn, fruiting vegetables, leafy
vegetables, cucurbits, tuber vegetables (potatoes), and strawberry; (ii)
30-day PBI for alfalfa, barley, oat, sugar beets, and wheat; (iii)
12-month PBI for all other crops.  Cover crops for soil building or
erosion control may be planted at any time, but do not graze or harvest
for food or feed.

Conclusions.  The proposed use directions are adequate to allow
evaluation of the residue data relative to the proposed use.  

860.1300 Nature of the Residue – Plants

Residue Chemistry Memo DP Num: 308837, 18/FEB/2005, G. Kramer, et al.

Residue Chemistry Memo DP Num: 300469, 17/FEB/2005, K. Martin, et al.

The nature of the residue in plant commodities is adequately understood
based on metabolism studies conducted with lettuce, cotton, tomato and
confined rotational crops (DP Num: 308837, 18/FEB/2005, G. Kramer, et
al.).  The results of these studies showed that spiromesifen is
metabolized in all RACs by the loss of the dimethylbutyric acid group to
yield BSN 2060-enol.  Further metabolism can include:  hydroxylation of
BSN 2060-enol to yield BSN 2060-2-hydroxymethyl or BSN
2060-4-hydroxymethyl; hydroxylation of BSN 2060-enol to yield BSN
2060-3-pentanol; oxidation of BSN 2060-3-pentanol or BSN 2060-2- or
-4-hydroxymethyl to give BSN 2060-2- or -4-hydroxymethyl-3-pentanol;
oxidation of BSN 2060-4-hydroxymethyl to give BSN 2060-pentanone or BSN
2060-4-aldehyde; oxidation of BSN 2060-2- or 4-hydroxymethyl-3-pentanol
to give BSN 2060-hydroxy-4-carboxy; and further hydroxylation of BSN
2060-4-hydroxymethyl-3-pentanol or BSN 2060-hydroxy-4-carboxy to give
BSN 2060-dihydroxy-4-carboxy.  The reviewed plant studies also indicate
that spiromesifen, when foliarly applied during the vegetative growth
stage, is not readily translocated.  

Spiromesifen and BSN 2060-enol are the residues of concern in crop
commodities for purposes of tolerance enforcement and risk assessment
(DP Num: 300469, 17/FEB/2005, K. Martin, et al.).  Additionally, BSN
2060-4-hydroxymethyl (free and conjugated) is a residue of concern in
leafy vegetables (risk assessment only) and rotational crops (tolerance
enforcement and risk assessment).

860.1300 Nature of the Residue - Livestock

DP Num: 308837, 18/FEB/2005, G. Kramer, et al.

DP Num: 300469, 17/FEB/2005, K. Martin, et al.

The nature of the residue in livestock commodities is adequately
understood based on metabolism studies conducted with lactating goats
and laying hens (DP Num: 308837, 18/FEB/2005, G. Kramer, et al.).  Based
on these studies, spiromesifen is metabolized in all RACs by the loss of
the dimethylbutyric acid group to yield BSN 2060-enol.  Further
metabolism can include hydroxylation of BSN 2060-enol to yield BSN
2060-2-hydroxymethyl or BSN 2060-4-hydroxymethyl; hydroxylation of BSN
2060-enol to yield BSN 2060-3-pentanol; oxidation of BSN 2060-3-pentanol
or BSN 2060-2- or -4-hydroxymethyl to give BSN 2060-2- or
-4-hydroxymethyl-3-pentanol; oxidation of BSN 2060-4-hydroxymethyl to
give BSN 2060-pentanone or BSN 2060-4-aldehyde; oxidation of BSN 2060-2-
or 4-hydroxymethyl-3-pentanol to give BSN 2060-hydroxy-4-carboxy; and
further hydroxylation of BSN 2060-4-hydroxymethyl-3-pentanol or BSN
2060-hydroxy-4-carboxy to give BSN 2060-dihydroxy-4-carboxy.  

Spiromesifen and BSN 2060-enol are the residues of concern in livestock
for purposes of tolerance enforcement and risk assessment (DP Num:
300469, 17/FEB/2005, K. Martin, et al.).  Additionally, BSN
2060-4-hydroxymethyl (free and conjugated) is a residue of concern in
ruminant commodities (tolerance enforcement and risk assessment).

860.1340 Residue Analytical Methods

DP Num: 308837, 18/FEB/2005, G. Kramer, et al.

DP Num: 305152, 14/JUL/2004, J. Tyler

DP Num: 305721, 15/NOV/2007, E. Kolbe

Enforcement methods:  An HPLC/MS/MS method, Method 00631/M001, was
submitted for the enforcement of tolerances for residues of
spiromesifen, BSN 2060-enol, and BSN 2060 4-hydroxymethyl in/on plant
commodities (DP Num: 308837, 18/FEB/2005, G. Kramer, et al.).  The
validated LOQ is 0.01 ppm for each analyte.  An LC/MS/MS Method 110878
was also submitted for determination of spiromesifin residues of concern
in livestock tissues and milk.  Validation data, including an
independent laboratory validation (ILV) and radiovalidation studies have
been submitted.  Both methods were submitted for PMV by ACB (DP Num:
305152, 14/JUL/2004, J. Tyler).  ACB recommended that each of the
methods (Plant Commodity, Rotational Plant Commodity and Livestock
Commodity) 1) appear to meet OPPTS 860.1340 Residue Chemistry Test
Guidelines for acceptable enforcement methods; 2) do not need to be
validated by an Agency Laboratory; and 3) have been independently
validated with recommendations for modifications (DP Num: 305721,
15/NOV/2007, E. Kolbe).

Data-collection method:  Samples of bean (dry shelled, succulent
shelled, and edible podded) seed and foliage from the submitted field
trials were analyzed for residues of spiromesifen and its enol
metabolite (BSN 2060-enol) using a variation of HPLC/MS/MS Method
00631/M001, which is essentially the same as the proposed enforcement
method for plants.  The LLMV for this method for each spiromesifen and
BSN 2060-enol was 0.01 ppm for dry shelled bean seed and 0.05 ppm for
succulent shelled bean seed, edible podded bean, and bean foliage. 
Acceptable method validation and concurrent method recoveries were
achieved with bean seed and foliage fortified with spiromesifen or BSN
2060-enol at 0.01-20 ppm.

Conclusions.  The modified HPLC/MS/MS Method 00631/M001 is adequate for
data collection.  The proposed enforcement methods, HPLC/MS/MS Method
00631/M001 for plants and LC/MS/MS Method 110878 for animals will be
forwarded to FDA for inclusion in PAM Vol. II, once the petitioner has
submitted a revised method incorporating the recommendations by ACB (DP
Num: 305721, 15/NOV/2007, E. Kolbe).

860.1360 Multiresidue Methods

DP Num: 308837, 18/FEB/2005, G. Kramer, et al.

Multiresidue method data for spiromesifen, BSN 2060-enol, and BSN 2060
4-hydroxymethyl were previously submitted (DP Num: 308837, 18/FEB/2005,
G. Kramer, et al.).  Spiromesifen was completely recovered using
multiresidue method Protocols D, E and F, for the analysis of nonoily
and fatty commodities.  The methods were not found to be suitable for
the determination of BSN 2060-enol and BSN 2060 4-hydroxymethyl.  Thus,
the MRM are not adequate for enforcement of tolerances which include
residues of spiromesifen and BSN 2060-enol.

860.1380 Storage Stability

47083501.der.doc, 15/NOV/2007, D. Rate (bean, dry shelled,
edible-podded, and succulent-shelled)

There are adequate storage stability data to support the storage
conditions and durations of samples collected from the bean field
trials.  A concurrent storage stability study was conducted with each
matrix for 355 days for dry shelled beans, 386 days for succulent
shelled beans, 442 days for edible podded beans, and 482 days for bean
foliage.  The results indicate that residues of spiromesifen and its
metabolite BSN 2060-enol are relatively stable in/on fortified samples
of dry shelled beans stored frozen for up to 355 days; however, residues
of spiromesifen appeared to degrade in/on fortified succulent shelled
beans, edible podded beans, and bean foliage at 386, 442, and 482 days,
respectively, while residues of BSN 2060-enol appeared to increase at
these storage durations.  The petitioner stated that minor degradation
occurred but the overall results demonstrated stability.  It is noted
that the storage stability testing period was slightly less than the
actual storage duration of samples.  The difference between the maximum
storage duration and the duration of demonstrated storage stability was
13-55 days.

The storage durations and conditions of samples from the crop field
trials 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

Dry shelled bean seeds	<-20	304-346 days 

(10-11.4 months)	Residues of spiromesifen and its metabolite BSN
2060-enol are relatively stable in/on dry shelled bean seeds for up to
355 days.

Succulent shelled beans seeds	<-20	332-399 days

(10.9-13.1 months)	Residues of spiromesifen are not stable in/on
succulent shelled bean seeds and dissipate when samples are stored for
up to 386 days.  However, residues of BSN 2060-enol increase in/on
succulent shelled bean seed samples when they are stored for up to 386
days.

Edible podded bean seeds	<-20	328-497 days

(10.8-16.3 months)	Residues of spiromesifen are not stable in/on edible
podded bean seeds and dissipate when samples are stored for up to 442
days.  However, residues of BSN 2060-enol increase in/on edible podded
bean seed samples when they are stored for up to 442 days.

Bean foliage	<-20	361-516 days

(11.9-17.0 months)	Residues of spiromesifen are not stable in/on bean
foliage and dissipate when samples are stored for up to 482 days. 
However, residues of BSN 2060-enol increase in/on bean foliage samples
when they are stored for up to 482 days.

Conclusions.  A storage stability study was conducted concurrently with
the magnitude of the residue study for beans.  The results indicate that
residues of spiromesifen and its metabolite BSN 2060-enol are relatively
stable in/on fortified samples of dry shelled beans stored frozen for up
to 355 days; however, residues of spiromesifen appeared to degrade in/on
fortified succulent shelled beans, edible podded beans, and bean foliage
at 386, 442, and 482 days, respectively, while residues of BSN 2060-enol
appeared to increase at these storage durations.  Since the
corresponding decrease of spiromesifen in some bean matrices is
accompanied by an increase in BSN 2060-enol, ARIA concludes that storage
stability is not an issue for the purpose of this petition and that the
observation is consistent with the biotransformation of residues
reported in the plant metabolism studies.

860.1400 Water, Fish, and Irrigated Crops

There are no proposed uses that are relevant to this guideline topic.

860.1460 Food Handling

There are no proposed uses that are relevant to this guideline topic.

860.1480 Meat, Milk, Poultry, and Eggs

DP Num: 308837, 18/FEB/2005, G. Kramer, et al.

Tolerances have been established [40 CFR §180.607(a)(2)] for the
combined residues of spiromesifen, its enol metabolite (BSN 2060-enol),
and its metabolites containing the 4-hydroxymethyl moiety (free and
conjugated), expressed as spiromesifen equivalents, at 0.05 ppm in the
fat and meat byproducts of cattle, goat, horse, and sheep and at 0.10
ppm in milk fat.

Livestock dietary burdens

There are livestock feedstuffs associated with the proposed uses in this
petition.  These feedstuffs include cowpea seed, cowpea forage, and
cowpea hay derived from the proposed use on succulent-shelled bean.  In
addition, feedstuffs associated with a previous spiromesifen petitions
include alfalfa (forage, hay, meal, and silage), barley (grain, hay, and
straw), corn (grain, forage, stover, aspirated grain fractions, milled
byproducts), cotton (seed, gin byproducts, meal, and hulls), oat (grain,
forage, hay, and straw), potato (culls and processed potato waste),
sugar beet (dried pulp and molasses), and wheat (grain, forage, hay,
straw, aspirated grain fractions, and milled byproducts).  Taking into
account these livestock feedstuffs and current agricultural practices,
the dietary burdens of spiromesifen to livestock are calculated in Table
5.  The calculations reflect the most recent guidance from HED
concerning revisions in OPPTS 860.1000 Table 1 Feedstuffs (October 2006)
and constructing reasonably balanced livestock diets (RBDs).  The
dietary burdens are 22 ppm for beef cattle, 22 ppm for dairy cattle,
0.04 ppm for swine, and 0.3 ppm for poultry.

Table 5.   Calculation of Dietary Burdens of Spiromesifen Residues to
Livestock. a, b

Feedstuff	Type	% Dry Matter	% Diet	Recommended Tolerance (ppm)	Dietary
Contribution (ppm)

Beef Cattle

cowpea, hay	R	86	20	86	20

corn, forage	R	40	15	3	1.13

cotton gin byproducts	R	90	5	15	0.83

corn, grain	CC	88	35	0.020	0.0008

beet, sugar, molasses/pulp	CC	75	10	0.030	0.004

cottonseed, meal	PC	89	15	0.50	0.084

Total	--	--	100	--	22

Dairy Cattle

corn, forage	R	40	25	3	1.88

cowpea, hay	R	86	20	86.0	20.0

corn, grain	CC	88	30	0.020	0.007

beet, sugar, molasses/pulp	CC	75	10	0.030	0.004

cottonseed, meal	PC	89	15	0.50	0.084

Total	--	--	100	--	22

Poultry

corn, grain	CC	89	70	0.02	0.014

wheat/barley/oat grain	CC	89	5	0.03	0.0015

alfalfa meal	R/PC	89	5	3.0	0.15

cottonseed,  meal	PC	89	20	0.5	0.1

Total	--	--	100	--	0.3

Swine

corn, grain	CC	88	80	0.02	0.016

wheat/barley/oat grain	CC	89	5	0.03	0.0015

cowpea seed	PC	88	10	0.2	0.02

Total	--	--	100	--	0.04

a  All data are based on Table 1 Feedstuffs (October 2006), a revision
of feedstuffs data found in Table 1 (180.1000 OPPTS Test Guidelines). 
Residue levels for beef and dairy are corrected for moisture content and
are determined by formula: tolerance / %DM  x  % in diet.  Residue
levels for poultry and swine are considered “as-is” and are
determined by formula: tolerance  x   % in diet.  R: roughage; CC:
carbohydrate concentrate;  PC:  protein concentrate.

b  For typical compositions of daily rations for the animals of choice
for Table 1 data see Appendix II. 

Dairy Cattle Feeding Study

DP Num: 308837, 18/FEB/2005, G. Kramer, et al.

  SEQ CHAPTER \h \r 1 A dairy cattle feeding study was reviewed in
PP#3F6537 (DP Num: 308837, 18/FEB/2005, G. Kramer, et al.)  Cattle were
fed 5, 15, and 50 ppm spiromesifen in the daily diet for 29 consecutive
days.  A summary of residue data from the ruminant feeding study with
spiromesifen is re-presented in Table 6.

Table 6.   Summary of Residue Data from Dairy Cow Feeding Study with
Spiromesifen.

Matrix	Feeding Level (ppm)	Residue Levels (ppm) 1

n	Minimum	Maximum	Median	Mean	Standard Deviation

Total Residues

Milk/Days 4-28	50	30	<0.005	0.017	0.008	0.008	0.003

Milk/Day 28	5 and 15	6	<0.005	<0.005	<0.005	<0.005	0

Skim Milk/Day 26	50	3	<0.010	<0.010	<0.010	<0.010	0

Cream/Day 26	50	3	0.021	0.036	0.024	0.027	0.008

Liver/Sacrifice	5	3	<0.050	<0.050	<0.050	<0.050	0

	15	3	<0.050	<0.050	<0.050	<0.050	0

	50	3	<0.050	0.074	<0.050	0.058	0.014

Kidney/Sacrifice	5	5	<0.050	<0.050	<0.050	<0.050	0

	15	3	<0.050	0.097	<0.050	0.066	0.027

	50	3	0.102	0.252	0.113	0.156	0.084

Muscle/Sacrifice	5	3	<0.010	<0.010	<0.010	<0.010	0

	15	3	<0.010	<0.010	<0.010	<0.010	0

	50	3	<0.010	0.011	<0.010	<0.010	0.001

Fat/Sacrifice	5	3	<0.010	<0.010	<0.010	0.010	0

	15	3	0.022	0.045	0.023	0.030	0.013

	50	3	0.055	0.118	0.110	0.094	0.034

1  All residues were reported in parent equivalents.  Total and average
residue values were extracted from the study report (MRID 45819412). 
Total residue values were calculated by addition of the measured residue
level for each analyte, including values below the LOD and LOQ.  

Residues of spiromesifen in skim milk, cream, and tissues are detected
as BSN 2060-enol.

The reported LOQ for total residues was equivalent to the LOQ for the
individual analytes in each matrix.

LOD=0.001 ppm for each analyte in milk.

LOD=0.002 ppm for each analyte in muscle, fat, skim milk, and cream

LOD=0.010 ppm for each analyte in kidney and liver.

LOQ=0.005 ppm for each analyte in milk. 

LOQ=0.010 ppm for each analyte in muscle, fat, skim milk, and cream

LOQ=0.050 ppm for each analyte in kidney and liver.

Expected secondary residues in meat and milk

In reassessing the established animal tolerances for the purpose of this
petition, the anticipated secondary residues in cattle matrices were
estimated using transfer coefficient factors calculated from the maximum
residues of spiromesifen observed at the dose level closest to the
reasonably balanced dietary burden (RBDB) in the dairy cattle feeding
study.  The transfer coefficients (calculated as residue level to feed
level ratios) are presented 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.  The expected residues of spiromesifen and the recommended
tolerances based on expected residues are presented in Table 8.

Table 7.   Residue-Level-to-Feed Ratios (Transfer Coefficients) in Dairy
Cattle Milk and Tissues.

Matrix	Maximum Total Residue of Spiromesifen (ppm)	Feeding Level

(ppm)	Transfer

Coefficient 1

Milk, whole	0.005	15	0.00033

Liver	0.050	15	0.0033

Kidney	0.097	15	0.0065

Muscle	0.010	15	0.0007

Fat	0.045	15	0.003

1  Calculated from the maximum residues observed at the dose level
closest to the RBDB divided by the dose level.

Table 8.   Expected Secondary Residues of Spiromesifen in Meat and Milk.

Matrix	Dietary Burden

(ppm)	Secondary Residues 1

(ppm)	Recommended Tolerance

(ppm)

Dairy Cattle

Milk, whole	22	0.007	0.01

Milk fat 2	22	0.175	0.20

Liver	22	0.07	0.15

Kidney	22	0.143

	Muscle	22	0.015	0.02

Fat	22	0.07	0.10

Swine

Liver	0.04	0.00013	NR3

Kidney	0.04	0.00026	NR

Muscle	0.04	0.00003	NR

Fat	0.04	0.00012	NR

1  Calculated from dietary burden x transfer coefficient from Table 7.

2  In the previous review, the milk fat residue was calculated by
multiplying the secondary residue in whole milk by 25 (maximum
concentration factor for milk fat).

3  NR = Not Required

Conclusions.  Based on the dietary exposure levels and the residue data
from an available ruminant feeding study, data indicate that a tolerance
of 0.01 ppm is recommended in milk, whole, 0.20 ppm in milk, fat, 0.02
ppm is needed for residues of spiromesifen in the meat of cattle, goats,
horses, and sheep, 0.15 ppm in meat, byproducts, of cattle, goats,
horses, and sheep, and 0.10 in the fat of cattle, goats, horses, and
sheep.  Based on the transfer coefficients for livestock tissues and the
relatively low dietary burden for swine of 0.04 ppm for spiromesifen,
tolerances in hogs are not needed.  A revised Section F is required for
the proposed tolerance increases in fat, meat and meat byproducts of
livestock commodities (cattle, goat, horse and sheep), as well as a
proposed tolerance in milk, and increased tolerance in milk, fat.  

Poultry

Based on a dietary burden of 0.3 ppm for poultry and the residues
identified in the poultry metabolism study, ARIA concludes that the
proposed use of spiromesifen on cowpea addressed in this document is not
expected to alter the Agency’s previous conclusion that there is no
reasonable expectation of finite residues in poultry commodities.  No
tolerances are needed in poultry and eggs.

860.1500 Crop Field Trials

Dry shelled, succulent shelled, and edible podded bean

47083501.der.doc, 15/NOV/2007, D. Rate (bean, dry shelled,
edible-podded, and succulent-shelled)

IR-4 submitted field trial data for spiromesifen on dry shelled,
succulent shelled, and edible podded bean.  Twenty-five bean field
trials were conducted during the 2005 growing season.  Ten trials were
performed on dry shelled bean in EPA growing Regions 5 (ND and WI; 4
trials), 7 (ND; 2 trials), 8 (CO; 2 trials), 10 (CA; 1 trial), and 11
(ID; 1 trial).  Seven trials were performed on succulent shelled bean in
EPA growing Regions 2 (MD, NC, and NJ; 3 trials), 5 (OH and WI; 2
trials), 10 (CA; 1 trial), and 11 (WA; 1 trial).  Eight trials were
performed on edible podded bean in EPA growing Regions 1 (NY and OH; 3
trials), 2 (GA, MD, and SC; 3 trials), 3 (FL; 1 trial), and 11 (WA; 1
trial).  

At each trial location, except for two trials, three foliar broadcast
spray applications of the 2 lb/gal flowable concentrate (FlC)
formulation of spiromesifen were made to beans at ~0.19 lb
ai/A/application, with a 6- to 8-day retreatment interval (RTI), for a
total seasonal rate of ~0.57 lb ai/A (1x the proposed maximum seasonal
rate).  At one trial, the crops received four applications and at a
second trial the crops received five applications to allow the crops to
reach maturity.  At six trials, the RTI was 10-14 days due to wet
conditions, oversights, or to allow the crop to mature.  Applications
were made in spray volumes of ~12-86 gal/A, without an adjuvant.  Dry
shelled bean seeds were harvested 9-10 days after the last application
(DALA) and succulent shelled and edible podded seeds and foliage were
harvested 1 DALA.  Additional samples were collected from one edible
podded bean trial (MD) at 1, 3, 7, 10, and 14 DALA to evaluate residue
decline.  

Samples of bean seed and foliage were analyzed for residues of
spiromesifen and its metabolite BSN 2060-enol using a variation of a
LC/MS/MS Method 00631.  The LLMV for this method for each spiromesifen
and BSN 2060-enol was 0.01 ppm for dry shelled bean seed and 0.05 ppm
for succulent shelled bean seed, edible podded bean, and bean foliage. 
The petitioner used the LLMV as the LOQ for reporting residue results.

This method is adequate for data collection based on overall method
recoveries.  Method validation and concurrent recoveries of spiromesifen
were generally within the acceptable range of 70-120%, with several low
method validation recoveries from edible podded bean seed (7 recoveries
of 63-69%, at 0.05 to 5.0 ppm) and bean foliage (5 recoveries of 57-67%
at 0.05-0.10 ppm).  Several concurrent recoveries were low from dry
shelled bean seed (6 recoveries of 51-67% at 0.01 ppm), succulent
shelled bean seed (2 recoveries of 61-64% at 0.05 ppm), edible podded
bean seed (5 recoveries of 48-68% at 0.05 ppm), and bean foliage (8
recoveries of 49-68% at 0.05-20.0 ppm).  Method validation and
concurrent recoveries of metabolite BSN 206-enol were all within the
acceptable range of 70-120%.  Adequate sample calculations and
chromatograms were provided.

The maximum storage durations of samples from harvest to analysis were
346 days (11.4 months) for dry shelled bean seed, 399 days (13.1 months)
for succulent shelled bean seed, 497 days (16.3 months) for edible
podded bean, and 516 days (17.0 months) for bean foliage.  Samples were
analyzed within 4 days of extraction.  To support the frozen storage
durations for the bean samples, a frozen storage stability study was
conducted concurrently with the field trials; see “860.1380 Storage
Stability” section for results.

A summary of residue data from the dry shelled, succulent shelled, and
edible podded bean field trials is presented in Table 9.  Maximum
residues of spiromesifen and its metabolite BSN 2060-enol were each
below the LLMV, (<0.01 ppm per analyte and <0.02 ppm for combined
residues) in/on dry shelled bean seed harvested 9-10 days after the
third, or for one trial, a fourth broadcast foliar application of the 2
lb/gal FlC formulation at total rates of 0.57-0.81 lb ai/A.  Maximum
residues of spiromesifen and BSN 2060-enol were each below the LLMV
(<0.50 ppm per analyte and <0.10 ppm for combined residues) in/on
succulent shelled bean seed harvested one day after a third broadcast
foliar application of the 2 lb/gal FlC formulation of spiromesifen at
total rates of 0.57-0.58 lb ai/A.  Maximum residues of spiromesifen and
BSN 2060-enol in/on edible podded bean harvested one day after receiving
a third or, for one trial, a fifth application of the 2 lb/gal FlC
formulation of spiromesifen at total rates of 0.57-0.95 lb ai/A were
0.39 ppm and 0.08 ppm, respectively and maximum total residues were 0.47
ppm.  Maximum residues of spiromesifen and BSN 2060-enol were 14.9 ppm
and 1.14 ppm, respectively, in/on succulent shelled and edible podded
bean foliage harvested one day after receiving a third or, for one
trial, a fifth application of the 2 lb/gal FlC formulation of
spiromesifen at total rates of 0.57-0.95 lb ai/A; maximum total residues
were 15.99 ppm in/on bean foliage.

Table 9.   Summary of Residue Data from Crop Field Trials with
Spiromesifen.

Commodity	Total Applic. Rate 

(lb ai/A)	Analyte	PHI (days)	Residue Levels (ppm)1

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

Proposed use = 0.57 lb ai/A total application rate,

1-day PHI for succulent and edible podded bean and 10-day PHI for dry
shelled bean

Dry shelled bean seeds	0.566-0.648	Spiromesifen	9-10	18	<0.01	<0.01
<0.01	0.01	0.01	--

BSN 2060-enol

18	<0.01	<0.01	<0.01	0.01	0.01	--

Total 

18	<0.02	<0.02	<0.02	0.02	0.02	--

	0.805	Spiromesifen	10	2	<0.01	<0.01	<0.01	0.01	0.01

	BSN 2060-enol

2	<0.01	<0.01	<0.01	0.01	0.01

	Total 

2	<0.02	<0.02	<0.02	0.02	0.02

	Succulent shelled bean seeds	0.568-0.579	Spiromesifen	1	14	<0.05	<0.05
<0.05	0.05	0.05	--

BSN 2060-enol

14	<0.05	<0.05	<0.05	0.05	0.05	--

Total

14	<0.10	<0.10	<0.10	0.10	0.10	--

Edible podded bean seeds	0.568-0.590	Spiromesifen	1	14	<0.05	0.39	0.33
0.11	0.14	0.11

BSN 2060-enol

14	<0.05	0.08	0.08	0.05	0.06	0.01

Total

14	<0.10	0.47	0.41	0.16	0.20	0.11

	0.949	Spiromesifen	1	2	<0.05	0.06	0.043	0.043	0.043

	BSN 2060-enol

2	<0.05	<0.05	<0.05	0.05	0.05

	Total 

2	<0.10	<0.11	<0.10	<0.10	<0.10

	Bean foliage

(succulent shelled)	0.568-0.579	Spiromesifen	1	14	0.51	10.9	10.6	3.57
4.28	3.24

BSN 2060-enol

14	0.15	0.65	0.64	0.38	0.40	0.17

Total

14	0.66	11.55	11.24	3.95	4.68	3.41

Bean foliage

(edible podded)	0.568-0.590	Spiromesifen	1	14	0.77	14.9	14.8	2.55	4.33
3.24

BSN 2060-enol

14	0.26	1.14	1.12	0.42	0.52	0.27

Total

14	1.03	15.99	15.92	3.56	5.34	4.91

	0.949	Spiromesifen

2	7.46	9.10	8.28	8.28	8.28

	BSN 2060-enol

2	0.62	0.73	0.68	0.68	0.68

	Total 

2	7.08	9.83	8.96	8.96	8.96

	Bean foliage

(succulent shelled and edible podded)	0.568-0.590	Spiromesifen	1	28	0.51
14.9	14.8	3.54	4.57	3.99

BSN 2060-enol

28	0.15	1.14	1.12	0.41	0.47	0.23

Total

28	0.66	15.99	15.92	3.94	5.03	4.21

	0.949	Spiromesifen

2	7.46	9.10	8.28	8.28	8.28

	BSN 2060-enol

2	0.62	0.73	0.68	0.68	0.68

	Total 

2	8.08	9.83	8.96	8.96	8.96

	1  For the calculation of total residues and determination of the HAFT,
median, mean, and standard deviation values, the LLMV (0.01 ppm for each
spiromesifen and its metabolite BSN 2060-enol in/on dry shelled bean
seeds and 0.05 ppm for each spiromesifen and its metabolite BSN
2060-enol in/on succulent shelled bean seeds and edible podded bean
seeds, and bean foliage) was used for residues reported as <LLMV.

2  HAFT = Highest Average Field Trial.

The submitted residue decline data indicated that total spiromesifen
residues (spiromesifen and its metabolite BSN 2060-enol) generally
declined or did not increase in edible podded bean with increasing
harvest intervals following the one day PHI used in the field trials.

Conclusions.  The submitted residue data are adequate to support the
proposed use of the of the FlC formulation on dry shelled, succulent
shelled, and edible podded beans.  Although the locations of the field
trials conducted for dried shelled bean and edible podded bean are not
in strict accordance with OPPTS Guideline 860.1500, the total number of
field trials is in accordance with OPPTS Guideline 860.1500, Table 4 for
dry shelled, succulent shelled, and edible podded beans as
representative commodities of the crop “group” Beans listed in 40
CFR 180.1(h).  Since the petitioner is proposing separate tolerances for
dry bean, succulent bean, and edible podded bean and these tolerances
vary by >5x this guidance may not be appropriate.  However, the number
of field trials would be in accordance with OPPTS Guideline 860.1500,
Tables 1 and 5 for minimum number of field trials for tolerances on
individual crops: dry shelled beans (9 trials) and succulent shelled
beans (6 trials) because a 25 percent reduction in the number of field
trials is possible due to the pesticidal use resulting in no
quantifiable residues in bean seed and the number would be in accordance
with OPPTS Guideline 860.1500, Table 1 for edible podded beans (8
trials).

The residue data for the dried shelled bean and succulent shelled bean
seed were not entered into the Agency’s tolerance spreadsheet because
all treated samples bore residues of spiromesifen and its metabolite BSN
2060-enol below the LLMV.  ARIA recommends tolerances of 0.02 ppm in/on
dry bean and 0.10 ppm in/on succulent bean for the combined residues of
spiromesifen and its metabolite BSN 2060-enol.  These recommendations
are identical to the levels proposed by the petitioner.

The residue data for edible-podded bean seed were entered into the
Agency’s tolerance spreadsheet as specified by the Guidance for
Setting Pesticide Tolerances Based on Field Trial Data SOP to determine
an appropriate tolerance level; see Appendix I.  Although the field
trial application rate for one edible podded bean trial is ~66% higher
the maximum label application rate, the submitted data from this trial
were also entered into the Agency’s tolerance spreadsheet since the
residue values for this field trial were within the range of residues of
the trials conducted at 1x.  The tolerance spreadsheet recommends an
individual tolerance of 0.80 ppm for edible podded bean which is lower
than that proposed by the petitioner.  A revised Section F is required
for the tolerance amendment.

The submitted data for bean foliage (succulent shelled and edible
podded) may be used to support a tolerance for cowpea forage.  According
to Table 1 of OPPTS 860.1000, cowpea is the only bean crop considered
for livestock feeding and is listed as a commodity for the succulent
shelled and dried shelled pea and bean subgroups, 6B and 6C,
respectively.  Since cowpea is not listed in the edible podded legume
vegetable subgroup 6A, only the residue data for succulent shelled bean
foliage were entered into the Agency’s tolerance spreadsheet as
specified by the Guidance for Setting Pesticide Tolerances Based on
Field Trial Data SOP to determine an appropriate tolerance level for
cowpea forage; see Appendix I.  The tolerance spreadsheet recommends an
individual tolerance of 30 ppm for cowpea forage which is lower than
that proposed by the petitioner.  A revised Section F is required for
the tolerance amendment.

No residue data were submitted for cowpea hay.  For the purpose of this
petition, ARIA will recommend a tolerance of 86 ppm for cowpea hay which
was calculated from the recommended tolerance for cowpea forage (30 ppm)
multiplied by the conversion factor (2.9x) derived when percentages of
dry matter (86% for cowpea hay and 30% for cowpea forage) are taken into
consideration.  A revised Section F is required to add a request for a
tolerance in cowpea, hay.

860.1520 Processed Food and Feed

HED does not require residue data for any processed commodities
associated with bean (dry shelled, edible-podded, and
succulent-shelled).  Hence, there are no proposed uses that are relevant
to this guideline topic.

  SEQ CHAPTER \h \r 1 860.1650 Submittal of Analytical Reference
Standards

Analytical standards for spiromesifen and one metabolite, spiromesifen
glycol are currently available in the EPA National Pesticide Standards
Repository.  In addition, very small amounts of deuterated standards of
the parent and other metabolites that are used for internal standards
for a specific MS analysis that was submitted by the registrant are
available (personal communication with Dallas Wright, ACB, 20/AUG/2007).
 

860.1850 Confined Accumulation in Rotational Crops

DP Num: 308837, 18/FEB/2005, G. Kramer, et al.

DP Num: 300469, 17/FEB/2005, K. Martin, et al.

A confined accumulation study in rotational crops has previously been
submitted and reviewed by HED (DP Num: 308837, 18/FEB/2005, G. Kramer,
et al.).  Spiromesifen (labeled at the 3-dihydrofuranone position) was
applied to soil at a rate equivalent to 0.714 lb ai/A (~1.25x the
proposed maximum seasonal use rate for beans).  The rotational crops
spring wheat, spinach, and turnips were sown at a number of time
intervals posttreatment (DALA):  30, 120-187, and 365 DALA and grown to
maturity.  Spring wheat from each aging period was sampled as forage
(approximately eight weeks after sowing), as wheat hay, and at mature
harvest, separated into straw and grain.  Spinach and turnip (root and
foliage separately) were sampled at mature harvest only.  Spiromesifen
is initially metabolized by hydrolysis of the dimethylbutyl carboxylic
ester group to form the ketoenol, BSN 2060-enol.  BSN 2060-enol is then
metabolized by hydroxylation of the methyl groups or cyclopentyl ring. 
BSN 2060-4-hydroxymethyl is the major residue that is conjugated with
glucose to form BSN 2060-4-hydroxymethyl-glucoside in varying
proportions, depending on the crop type.  Natural incorporation of
radioactivity into the starch and polymeric constituents of the plant
cell matrix is observed.

The residues of concern in rotational crops for purposes of tolerance
enforcement and risk assessment are parent plus BSN2060-enol and BSN
2060-4-hydroxymethyl (DP Num: 300469, 17/FEB/2005, K. Martin, et al.). 
Based on the levels of these residues found in the confined accumulation
study, a 365-day PBI is appropriate for all unregistered crops.  Limited
field accumulation in rotational crop studies are required to support
shorter PBIs.

860.1900 Field Accumulation in Rotational Crops

DP Num: 308837, 18/FEB/2005, G. Kramer, et al.

DP Num: 365026 and 366487, 04/AUG/2006, G. Kramer

No field rotational crop data have been submitted in the current
petition.  Field rotational crop data for alfalfa, barley, sugar beets,
and wheat have previously been submitted and reviewed by HED (DP Num:
308837, 18/FEB/2005, G. Kramer, et al.).  As a result, a conditional
registration and permanent tolerances for the inadvertant or indirect
combined residues of spiromesifen, its enol metabolite, and its
metabolites containing the 4-hydroxymethyl moiety were established on
the following rotational crop commodities:  alfalfa (forage and hay),
barley (grain, hay, and straw), sugar beet (roots and tops), and wheat
(forage, grain, hay, and straw).  HED recommended that conversion of
conditional registration to unconditional registration may be considered
provided that additional storage stability data are submitted for the
commodities analyzed in the Field Accumulation in Rotational Crops
studies in order to validate the 22-month storage intervals.  

In conjunction with a previous petition (PP#6F7039; DP Num: 328205 and
328206, 04/AUG/2006, G. Kramer) to amend the use pattern for the 2
lb/gal FlC formulation of spiromesifen (Oberon® 2SC; EPA Reg. No.
264-719) to allow oats to be planted as a rotational crop with a 30-day
PBI and to establish rotational crop tolerances for oat commodities, the
petitioner requested that field rotational crop data for alfalfa,
barley, sugar beets, and wheat be translated to oats.  HED concluded
that there were no residue chemistry deficiencies that would preclude
granting a 30-day PBI for spiromesifen on oats and required a revised
Section F to specify rotational crop tolerances for oat commodities.  

The following rotational crop restrictions are specified for the 2
lb/gal FlC formulation of spiromesifen (Oberon® 2SC; EPA Reg. No.
264-719):  (i) immediate PBI for cotton, field corn, fruiting
vegetables, leafy vegetables, cucurbits, tuber vegetables (potatoes),
and strawberry; (ii) 30-day PBI for alfalfa, barley, sugar beets, and
wheat; (iii) 12-month PBI for all other crops.  Cover crops for soil
building or erosion control may be planted at any time, but do not graze
or harvest for food or feed.

860.1550 Proposed Tolerances

HED has previously determined that the residues of concern in:  (i)
plant and livestock (except ruminant) commodities are spiromesifen and
its enol metabolite (BSN 2060-enol), expressed as spiromesifen
equivalents and (ii) ruminant and rotational crop commodities are
spiromesifen, its enol metabolite (BSN 2060-enol), and its metabolites
containing the 4-hydroxymethyl moiety (free and conjugated), expressed
as spiromesifen equivalents.  The proposed tolerance expression is
consistent with the spiromesifen tolerances established in 40 CFR
§180.607(a)(1) and (a)(2).

Pending submission of a revised Section F, the submitted crop field
trial data for dry shelled, succulent shelled, and edible podded beans
are adequate to set tolerances.

The residue data for the dried shelled bean and succulent shelled bean
seed were not entered into the spreadsheet because all of the respective
treated samples bore residues of spiromefisen and its metabolite BSN
2060-enol each below the LLMV.  ARIA recommends tolerances of 0.02 ppm
in/on dry bean and 0.10 ppm in/on succulent bean for the combined
residues of spiromefisen and its metabolite BSN 2060-enol.  These
recommendations are identical to the levels proposed by the petitioner.

The residue data for edible-podded bean seed were entered into the
Agency’s tolerance spreadsheet as specified by the Guidance for
Setting Pesticide Tolerances Based on Field Trial Data SOP to determine
an appropriate tolerance level; see Appendix I.  Although the field
trial application rate for one edible podded bean trial is ~66% higher
the maximum label application rate, the submitted data from this trial
were also entered into the Agency’s tolerance spreadsheet since the
residue values for this field trial were within the range of residues of
the trials conducted at 1x.  The tolerance spreadsheet recommends an
individual tolerance of 0.80 ppm for edible podded bean which is lower
than that proposed by the petitioner.

The submitted data for bean foliage (succulent shelled and edible
podded) may be used to support a tolerance for cowpea forage.  According
to Table 1 of OPPTS 860.1000, cowpea is the only bean crop considered
for livestock feeding and is listed as a commodity for the succulent
shelled and dried shelled pea and bean subgroups, 6B and 6C,
respectively.  Since cowpea is not listed in the edible podded legume
vegetable subgroup 6A, only the residue data for succulent shelled bean
foliage were entered into the Agency’s tolerance spreadsheet as
specified by the Guidance for Setting Pesticide Tolerances Based on
Field Trial Data SOP to determine an appropriate tolerance level for
cowpea forage; see Appendix I.  The tolerance spreadsheet recommends an
individual tolerance of 30 ppm for cowpea forage which is lower than
that proposed by the petitioner.

For the purpose of this petition, ARIA will recommend a tolerance of 86
ppm for cowpea hay which was calculated from the recommended tolerance
for cowpea, forage (30 ppm) multiplied by the conversion factor (2.9x)
derived when percentages of dry matter (86% for cowpea, hay and 30% for
cowpea, forage) are taken into consideration.  

Based on the dietary exposure levels and the residue data from an
available ruminant feeding study, data indicate that a tolerance of 0.01
ppm is recommended in milk, whole, 0.20 ppm in milk, fat, 0.02 ppm is
needed for residues of spiromesifen in the meat of cattle, goats,
horses, and sheep, 0.15 ppm in meat, byproducts, of cattle, goats,
horses, and sheep, and 0.10 in the fat of cattle, goats, horses, and
sheep.  Based on the transfer coefficients for livestock tissues and the
relatively low dietary burden for swine of 0.04 ppm for spiromesifen,
tolerances in hogs are not needed.  A revised Section F is required for
the proposed tolerance increases in fat, meat and meat byproducts of
livestock commodities (cattle, goat, horse and sheep), as well as a
proposed tolerance in milk, and increased tolerance in milk, fat.  

Tolerances in eggs and poultry are not needed at this time based on a
dietary burden of 0.3 ppm for poultry and the residues identified in the
poultry metabolism study, ARIA concludes that the proposed use of
spiromesifen on cowpea addressed in this document are not expected to
alter the Agency’s previous conclusion that there is no reasonable
expectation of finite residues in poultry commodities.

No Codex, Canadian, or Mexican maximum residue limits (MRLs) have been
established for residues of spiromesifen and its metabolites.  An
International Residue Limit status sheet is attached.

A summary of the recommended tolerances for the crop commodities
discussed in this Summary Document is presented in Table 10.  The
petitioner should submit a revised Section F reflecting the recommended
tolerances presented in Table 10.

Table 10.   Tolerance Summary for Spiromesifen.

Commodity	Established Tolerance

(ppm)	Proposed Tolerance (ppm)	Recommended Tolerance (ppm)	Comments;

Correct Commodity Definition

Amends 40 CFR §180.607(a)(1):  Primary Crops

Bean, dry	None	0.02	0.02

	Bean, succulent	None	0.10	0.10

	Bean, edible podded 1	None	1.4	0.80

	Cowpea, forage	None	35	30

	Additional Tolerance on Primary Crop Commodities That Needs to be
Proposed/Established

Cowpea, hay	None	None	86 2

	Amends 40 CFR §180.607(a)(2):  Livestock Commodities

Cattle, fat	0.05	0.20	0.10

	Cattle, meat	None	0.01	0.02

	Cattle, meat byproducts	0.05	0.30	0.15	.

Goat, fat	0.05	0.20	0.10

	Goat, meat	None	0.01	0.02

	Goat, meat byproducts	0.05	0.30	0.15

	Hog, fat	None	0.20	Not required	Based on the transfer coefficients for
livestock tissues and a relatively low dietary burden for swine of 0.04
ppm for spiromesifen, tolerances for swine are not needed

Hog, meat	None	0.01	Not required

	Hog, meat byproducts	None	0.30	Not required

	Horse, fat	0.05	0.20	0.10	.

Horse, meat	None	0.01	0.02

	Horse, meat byproducts	0.05	0.30	0.15

	Milk	None	0.01	0.01

	Milk, fat	0.10	None	0.20 

	Sheep, fat	0.05	0.20	0.10

	Sheep, meat	None	0.01	0.02

	Sheep, meat byproducts	0.05	0.30	0.15

	1  According to the Food Feed Commodity Vocabulary edible podded bean
is not listed as a preferred term, however, in an email correspondence
between B. Schneider and the petitioner, dated 09/JAN/2007, B. Schneider
indicated that bean, edible podded is the correct tolerance term.

2   Calculated from the recommended tolerance for cowpea forage (30 ppm)
multiplied by the conversion factor (2.9x) derived when percentages of
dry matter (86% for cowpea hay and 30% for cowpea forage) are taken into
consideration.

References

DP Num:	305721

Subject:	Review of Residue Analytical Method Data Submitted to Support
Food Tolerances for Spiromesifen (BSN 2060) on Various Raw Agricultural
and Livestock Commodities. 

From:		E. Kolbe,

To:		D. Vogel

Dated:		15/NOV/2007

MRID(s):	45854504, 45819421, 45854503, 45819413, 45819422, 45819416,
45819423

DP Num:	308837

Subject:	Spiromesifen in/on Strawberry, Tuberous and Corm Vegetables,
Brassica Vegetables, Leafy Greens Vegetables (except brassica), Fruiting
Vegetables, Cucurbit Vegetables, Field Corn and Cotton.  PP#3F6537. 
Summary of Analytical Chemistry and Residue Data.

From:		G. Kramer, et al.

To:		J. Hebert

Dated:		18/FEB/2005

MRID(s):	45819404-31, 45819501-06, 45890301, 45932401

DP Num:	300469

Subject:	Spiromesifen.  Human Health Risk Assessment for Proposed Uses
on Alfalfa; Barley; Corn; Cotton; Strawberry; Sugarbeet; Tomato;
Vegetable (Brassica, head and stem subgroup; Brassica, leafy subgroup;
cucurbit group; fruiting group; leafy greens subgroup (except Brassica);
tuberous and corm subgroup; wheat.  PC Code:  024875.  PP#3F6537.

From:		K. Martin, et al.

To:		J. Hebert/T. Harris

Dated:		17/FEB/2005

MRID(s):	None

DP Num:	305152

Subject:	Spiromesifen (BSN 2060) on Various Raw Agricultural and
Livestock Commodities.  Request Petition Method Validation (PMV).

From:		J. Tyler

To:		F. Siegelman

Dated:		14/JUL/2004

MRID(s):	45854504, 45819413, 45819416, 45819421, 45819422, 45819423

  SEQ CHAPTER \h \r 1 Attachments:  

International Residue Limit Status sheet

Appendix I - Tolerance Assessment Calculations

Appendix II – Livestock Diets and Dietary Burden Comments



√  Proposed tolerance

√  Reevaluated tolerance

( Other	Date:  08/15/07

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:  PP#7E7195

DP#:  TBD

Other Identifier: Decision No.

Residue definition (step 8/CXL): N/A	Reviewer/Branch:  C. Swartz and J.
Redden/RAB2 and ARIA [RAB1 chemical]

	Residue definition for primary crop commodities:  combined residues of
spiromesifen and its enol metabolite
[4-hydroxy-3-(2,4,6-trimethylphenyl)-1-oxaspiro[4.4]non-3-en-2-one],
expressed as spiromesifen equivalents

√  No Limits

( No Limits for the crops requested	√  No Limits

( No Limits for the crops requested

Residue definition:  N/A

	Residue definition:  N/A

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

	Notes/Special Instructions:  

S.Funk, 08/17/2007.

Appendix I.  Tolerance Assessment Calculations

Bean seed (dried shelled, succulent shelled, and edible podded)

The residue data for the dried shelled bean and succulent shelled bean
seed were not entered into the spreadsheet because >15% of the
respective treated samples bore residues below the LOQ.  Only the
residue data for edible podded bean seed were entered into the tolerance
spreadsheet.  The dataset used to establish a tolerance for spiromesifen
on edible podded bean seed consisted of field trial data representing
application rates of 0.568-0.949 lb ai/A (3 or 5 applications at
0.186-0.201 lb ai/A/application) with a 1-day PHI.  As specified by the
Guidance for Setting Pesticide Tolerances Based on Field Trial Data SOP,
the field trial application rates and PHIs are within 25% of the maximum
label application rate and minimum label PHI, respectively, with the
exception of one trial.  Although the field trial application rate for
one trial is ~66% higher the maximum label application rate, the
submitted data were entered into the Agency’s tolerance spreadsheet
since the residue values for this field trial were within the range of
residues of the trials conducted at 1x.  The residues values used to
calculate the tolerance are provided in Table II-1.

Since >30% (5 of 16 samples) of the field trial sample results for
edible podded bean seed were below the LOQ, maximum likelihood
estimation (MLE) procedures were needed to impute censored values.  The
residue data for edible podded bean seed were first entered into the MLE
spreadsheet to obtain the censored values and the spiromesifen-edible
podded bean seed (MLE) dataset was then entered into the tolerance
spreadsheet.  

After entering the spiromesifen-edible podded bean seed (MLE) dataset
into the tolerance spreadsheet, visual inspection of the lognormal
probability plot (Figure II-1) provided in the spreadsheet indicates
that the dataset is reasonably lognormal.  The result from the
approximate Shapiro-Francia test statistic (Figure II-2) confirmed that
the assumption of lognormality should not be rejected.

Since the field trial data for spiromesifen on edible podded bean seed
represent a large dataset (i.e., more than 15 samples) and are
reasonably lognormal, the minimum of the 95% upper confidence limit
(UCL) on the 95th percentile and the point estimate of the 99th
percentile should be selected as the tolerance value.  Using the
rounding procedure as outlined in the Guidance for Setting Pesticide
Tolerances Based on Field Trial Data SOP, the point estimate of the 99th
percentile rounds to the value 0.80 ppm (Figure II-2).  Because the
0.80-ppm value was the minimum value, 0.80 ppm is the recommended
tolerance level for spiromesifen on edible podded bean seed.

Table II-1.	Residue data used to calculate tolerance for spiromesifen on
edible podded bean seed.

Regulator:	EPA

Chemical:	Spiromesifen

Crop:	Edible podded bean seed (MLE)

PHI:	1 Day

App. Rate:	0.568-0.949 lb ai/A (3 or 5 at 0.186-0.201 lb
ai/A/application)

Submitter:	IR-4

MRID Citation:	MRID 47083501

	Combined Residues of Spiromesifen and BSN 2060-enol (ppm)

	0.120

	0.110

	0.340

	0.470

	0.210

	0.230

	0.190

	0.320

	0.045

	0.058

	0.069

	0.080

	0.320

	0.240

	0.110

	0.090

Figure II-   SEQ Figure_II- \* ARABIC  1 .  Lognormal probability plot
of spiromesifen field trial data for edible podded bean seed.

Figure II- 2.   Tolerance spreadsheet summary of spiromesifen field
trial data for edible podded bean seed.

Bean, foliage

In the current submission, data were collected on bean foliage
(succulent shelled and edible podded).  According to Table 1 of OPPTS
860.1000, cowpea is the only bean crop considered for livestock feeding
and is listed as a commodity for the succulent shelled and dried shelled
pea and bean subgroups, 6B and 6C, respectively.  Since cowpea is not
listed in the edible podded legume vegetable subgroup 6A, only the
residue data for succulent shelled bean foliage were entered into the
tolerance spreadsheet.   

The dataset used to establish a tolerance for spiromefisen on cowpea
forage consisted of succulent shelled bean foliage field trial data
representing application rates of 0.568-0.579 lb ai/A (3 applications at
0.187-0.196 lb ai/A/application) with a 1-day PHI.  As specified by the
Guidance for Setting Pesticide Tolerances Based on Field Trial Data SOP,
the field trial application rates and PHIs are within 25% of the maximum
label application rate and minimum label PHI, respectively.  The
residues values used to calculate the tolerance are provided in Table
II-2.

All 14 field trial sample results were above the LOQ.  Since there were
no values reported below the LOQ, maximum likelihood estimation (MLE)
procedures were not needed to impute censored values. 

The spiromesifen-succulent shelled bean foliage dataset was entered into
the tolerance spreadsheet.  Visual inspection of the lognormal
probability plot (Figure II-3) provided in the spreadsheet indicates
that the dataset is reasonably lognormal.  The result from the
approximate Shapiro-Francia test statistic (Figure II-4) confirmed that
the assumption of lognormality should not be rejected.

Since the field trial data for spiromesifen on succulent shelled bean
foliage represent a small dataset (i.e., less than 15 samples) and are
reasonably lognormal, the upper bound estimate of the 95th percentile
based on the median residue value was compared to the minimum of the 95%
upper confidence limit (UCL) on the 95th percentile and the point
estimate of the 99th percentile, and the minimum value was selected as
the tolerance value.  Using the rounding procedure as outlined in the
Guidance for Setting Pesticide Tolerances Based on Field Trial Data SOP,
the upper bound estimate of the 95th percentile based on median and the
point estimate of the 99th percentile both round to the value 30 ppm
(Figure II-4).  Because this value was the minimum value, 30 ppm is the
recommended tolerance level for spiromesifen on cowpea forage.

Table II-2.	Residue data used to calculate tolerance for spiromesifen on
cowpea forage.

Regulator:	EPA

Chemical:	Spiromesifen

Crop:	Succulent shelled bean foliage

PHI:	1 Day

App. Rate:	0.568-0.579 lb ai/A (3 at 0.187-0.196 lb ai/A/application)

Submitter:	IR-4

MRID Citation:	MRID 47083501

	Combined Residues of Spiromesifen and BSN 2060-enol (ppm)

	3.31

	2.01

	0.80

	0.66

	3.85

	4.08

	1.84

	2.89

	6.64

	7.24

	11.52

	10.85

	5.44

	4.39

Figure II- 3.  Lognormal probability plot of spiromesifen field trial
data for succulent shelled bean foliage.

Figure II- 4.   Tolerance spreadsheet summary of spiromesifen field
trial data for succulent shelled bean foliage.

Appendix II.  Livestock Diets and Dietary Burden Comments:

Compositions of daily rations for the animals of choice:

Cattle

Feedlot beef  have a daily ration of 15-40 %  R, 45-80 %  CC, and 10-15
%  PC.  As the slaughter time (last 3 months) gets closer, then the beef
cattle are fed higher amounts of CC (up to 80 %), and lower amounts of 
R (15-20 %) and PC (5-10 %).  The average life span for feedlot beef is
16-18 months.  Most of feedlot beef are slaughtered in 4 major centers
located in the Midwest and the processed meat is “boxed” and shipped
to distributors for sale to local grocers.  Commercial ground beef
(75-93 % lean) is produced from the combination of feedlot beef (60-70 %
lean) and other lean meat sources, i.e., beef cows and bulls from
cow-calf operations, imported lean meat trimmings, and replacement
non-lactating dairy cows. 

Dairy Cattle

High volume milk-producing lactating dairy cows have a daily ration of
45 % R, 40-45 % CC, and 10-15 % PC.  Dairy cows usually produce 2-3
calves before slaughter. The average life span of the lactating dairy
cow is 3-4 years.  Upon slaughter, much of the meat is used in ground
beef and processed foods e.g., deli meats, soups, frozen
dinners/entrees.

Poultry

A laying hen that will give a steady egg production is fed 75-80 % CC
and 20-25 % PC.   The life span can be up to 18 months.  In general,
laying hens are not processed and marketed as whole or cut-up chickens.
Much of the layer meat is used in processed food products, e.g., deli
meats, soups, canned chicken, etc.  (Note:  The laying hen is the animal
of choice.  Frying and rotisserie chickens come from the broiler, a fast
food chicken, weighing 3.5-4.0 lb.), and an animal that is raised in a
very short time.  The average life span is 38-42 days.  The broiler diet
contains 85-90 % CC and 10-15 % PC.    

Swine

A marketable hog diet that will give steady growth would have 80-85 % CC
and 15-20 % PC.  Most of the US hog production is confined to “mega”
operations.  Animals are born in in-house nurseries, and simply moved to
connecting buildings as the animal grows until slaughter (250 lb
finished animal in 6 months). These animals provide meat for the
“fresh pork” market.

Comments:

1.  Tolerances are established for residues of spiromesifen and its
metabolites in/on following feedstuff commodities:  corn, field, forage;
corn, field, grain; corn, field, stover; cotton, gin byproducts; cotton,
undelinted seed.   Tolerances are also established for indirect or
inadvertent residues of the same in/on alfalfa, forage; alfalfa hay;
barley/ oat/wheat, grain; barley/ oat/wheat, hay; barley/ oat/wheat,
straw; beet, sugar, root; beet, sugar, tops..  The proposed new crops
are beans which include cowpeas; thus, tolerances are proposed for
cowpea, forage and cowpea, hay.  The proposed tolerance for bean, dry
would apply to cowpea, seed.  

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2.   The following table lists comments for the above feedstuffs and
their consideration in the proposed diets burden for each animal class.

3.  Estimated dietary burdens are rounded.  Inclusion/exchange of the
feedstuffs listed in comment 1 will not affect the rounded numbers. 

4.  Cowpea hay is included in the diet, but would be available to a very
small number of dairy cows, mainly in the states of TX, Fl, MO, and OK. 
Estimated annual production is 6000 tons.  Potential residues from
feeding cowpeas hay would be in these selected areas only.  Thus, it may
be possible that cowpea hay could be replaced with corn forage or
alfalfa hay and not affect the potential risk.

Page   PAGE  34  of   NUMPAGES  34 

Spiromesifen	Summary of Analytical Chemistry and Residue Data	DP Num:
345985