UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, D.C.  20460

OFFICE OF

PREVENTION, PESTICIDES

AND TOXIC SUBSTANCES

MEMORANDUM

Date:  12/14/2007

Subject:		PP#6E7167; Bifenazate; (000586).  Petition for Establishment
of Tolerances for Uses on Caneberry (Crop Subgroup Group 13A); Wild
Raspberry; Edible-podded Legume Vegetable (Crop Subgroup 6A);
Succulent-shelled Pea and Bean (Crop Subgroup 6B); Soybean,
Succulent-shelled; and Various Tropical Fruits Including Papaya, Star
Apple, Black Sapote, Mango, Sapodilla, Canistel, Mamey Sapote, Lychee,
Longan, Spanish Lime, Rambutan, Pulasan, Guava, Feijoa, Jaboticaba, Wax
Jambu, Starfruit, Passionfruit, and Acerola.  Summary of Analytical
Chemistry and Residue Data.

DP No.:	337530	Decision No:	373262

PC Code:	000586	MRID Nos.:	47016701, 47016702, 47016703, 47016704,
47016705, 47016706, 47016707, 47016708

40 CFR §180.	572

Chemical Class:	Miticide/Insecticide

From:		William D. Wassell, Chemist

		Registration Action Branch 1 (RAB1)

		Health Effects Division (HED, 7509P)

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

		RAB1/HED (7509P)

To:		Daniel Rosenblatt, RM 05

	Registration Division (7505P)

This document was originally prepared under contract by Dynamac
Corporation (2275 Research Blvd, Suite 300; Rockville, MD 20850;
submitted 08/15/2007.  The document has been reviewed by the HED and
revised to reflect current Office of Pesticide Programs (OPP) policies.

Executive Summary

Bifenazate is a selective miticide/insecticide which controls the motile
stage of mites either by direct contact or through contact with foliar
residues.  Bifenazate blocks or closes the GABA-(gamma-aminobutyric
acid) activated-chloride channels of susceptible pests resulting in
over-excitation of the peripheral nervous system.

The Interregional Research Project No. 4 (IR-4), on behalf of the
Agricultural Experiment Stations of AR, CA, DE, FL, MI, NC, OR, PA, TN,
and WA, has submitted a petition, PP#6E7167, proposing the establishment
of permanent tolerances for residues of the insecticide bifenazate
(1-methylethyl 2-(4-methoxy[1,1’-biphenyl]-3-yl) hydrazinecarboxylate)
and its metabolite D3598 [diazinecarboxylic acid,
2-(4-methoxy-[1,1’-biphenyl]-3-yl, 1-methylethyl ester] (expressed as
bifenazate) in/on the following raw agricultural commodities:

Papaya	6.0 ppm

Star apple	6.0 ppm

Black sapote	6.0 ppm

Mango	6.0 ppm

Sapodilla	6.0 ppm

Canistel	6.0 ppm

Mamey sapote	6.0 ppm

Lychee	4.0 ppm

Longan	4.0 ppm

Spanish lime	4.0 ppm

Rambutan	4.0 ppm

Pulasan	4.0 ppm

Guava	0.9 ppm

Feijoa	0.9 ppm

Jaboticaba	0.9 ppm

Wax jambu	0.9 ppm

Starfruit	0.9 ppm

Passionfruit	0.9 ppm

Acerola	0.9 ppm

Caneberry subgroup 13A	6.0 ppm

Wild raspberry	6.0 ppm

Vegetable, legume, edible-podded, subgroup 6A	4.0 ppm

Pea and bean, succulent-shelled, subgroup 6B*	0.3 ppm

Soybean, succulent-shelled	0.3 ppm

* -IR-4 previously submitted a relevant bifenazate petition (PP#5E6992;
DP# 324430, 7/19/06, T. Bloem) proposing uses on garden peas (succulent
and shelled pea) and edible-podded peas.

Concurrently,   SEQ CHAPTER \h \r 1 IR-4 requests the amendment of the
end-use product labels for Acramite®-50 WS (EPA Reg. No. 400-503), a
50% wettable-powder (WP) formulation, to include new uses on caneberry
subgroup 13A; wild raspberry; and the tropical fruits:  papaya, star
apple, black sapote, mango, sapodilla, canistel, mamey sapote, lychee,
longan, Spanish lime, rambutan, pulasan, guava, feijo, jaboticaba, wax
jambu, starfruit, passionfruit, and acerola.  IR-4 has also requested to
amend the registration of Acramite®-4SC (EPA Reg. No. 400-514), a 4
lb/gal soluble-concentrate (SC) formulation [equivalent to a flowable
concentrate (FlC)], to include new uses on succulent legume vegetables
subgroup 6A; succulent-shelled beans, subgroup 6B; succulent-shelled
soybean; and succulent pea including succulent-shelled, edible-podded,
and pigeon.  Both products are proposed for one foliar spray application
on the crops listed above using ground or aerial equipment at a maximum
seasonal rate of 0.5 lb ai/A.  The proposed pre-harvest intervals (PHIs)
range from 1 to 3 days.

Tolerances are established for residues of bifenazate (40 CFR
§180.572(a)(1)) and are expressed in terms of the combined residues of
bifenazate and D3598 (expressed as bifenazate).  The established
tolerances for residues in/on plant commodities and livestock fat, under
40 CFR §180.572(a)(1), range from 0.10 ppm (tuberous and corm
vegetables, subgroup 1C and fat of cattle, goat, hog, horse, and sheep)
to 35 ppm (cotton gin byproducts).  Tolerances are established (40 CFR
§180.572(a)(2)) for residues in milk, and meat and meat byproducts of
cattle, goat, hog, horse, and sheep at 0.02 ppm and are expressed in
terms of the combined residues of bifenazate, D3598 (expressed as
bifenazate), A1530, and A1530-sulfate (expressed as A1530).  In
addition, time-limited tolerances for residues of bifenazate and D3598
are established under 40 CFR §180.572(b) in connection with Section 18
Emergency Exemptions; these include tolerances for  residues in/on
potato at 0.05 ppm with a 12/31/06 expiration date; tart cherry at 5.0
ppm, soybean hulls at 20 ppm, soybean meal at 3.5 ppm, soybean refined
oil at 20 ppm, and soybean seed at 1.5 ppm with a 12/31/09 expiration
date; and timothy forage at 50 ppm and timothy hay at 150 ppm with a
12/31/07 expiration date.

The nature of the residue in plants is adequately understood based on
acceptable studies with radish, apple, orange, and cotton.  The
metabolic routes in all crops were found to be similar and proceeded via
oxidation of the hydrazine moiety of bifenazate to form the metabolite
D3598 which is further degraded to D1989, D9963, D4642, and/or A1530 and
to bound residues by reaction with natural products.  For purposes of
tolerance expression and risk assessment, the HED Metabolism Assessment
Review Committee (MARC) has previously determined that the residues of
concern in plants are bifenazate and its metabolite D3598.

The nature of the residue in livestock is adequately understood based on
studies with lactating goats and laying hens.  The HED MARC has
determined that for tolerance expression and risk assessment purposes,
the residues of concern in livestock tissue (excluding fat), eggs, and
milk are bifenazate and the metabolites D3598 (expressed as bifenazate),
A1530, and A1530-sulfate (expressed as A1530).  The residues of concern
for tolerance expression and risk assessment purposes in fat are
bifenazate and D3598 (expressed as bifenazate).  Based on the ruminant
metabolism (goat; 10 ppm dietary burden) and the dairy cow feeding study
(1 ppm, 3 ppm, and 10 ppm dietary burdens), the HED MARC determined that
for tolerance expression and risk assessment purposes the residues of
concern in milk are bifenazate, D3598 (expressed as bifenazate), A1530,
and A1530-sulfate (expressed as A1530; D276801, T. Bloem, 16-Aug-2001).
A milk tolerance of 0.02 ppm (LOQ tolerance) is currently established
and is based on the 6.99 ppm dairy cattle dietary burden (D290053, T.
Bloem, 29-May-2003; D324430, T. Bloem, 19-July-2006) and the dairy cow
feeding study which resulted in residues of bifenazate/D3598 and
A1530/A1530-sulfate of <0.01 ppm in all of the whole milk samples
(D277089, T. Bloem, 16-Aug-2001; analytical method does not distinguish
between D3598 and bifenazate nor A1530 and A1530-sulfate).

Subsequent to the MARC decision, the petitioner submitted a
radiovalidation study for the livestock enforcement method.  In order to
generate samples for this study, a goat was dosed with radiolabeled
bifenazate (20 ppm dietary burden; 46691301.der.wpd).  Milk, fat, and
liver samples were collected and analyzed.  Contrary to the ruminant
metabolism study which indicated that A1530-sulfate was the major
residue in milk (41% TRR; D9569 was a minor residue), the
radiovalidation study indicated that D9569 was the major residue (24%
TRR; A1530-sulfate was a minor residue); no differences in the fat and
liver metabolic profile were indicated.  The petitioner has submitted
data confirming the identify of A1530-sulfate in the ruminant metabolism
study (isolated peak degraded to A1530 upon treatment with
glucuronidase/sulfatase) and confirming the identify of D9569 in the
radiovalidation study (D9569 identified using two methods; MRID
47058901).  Therefore, the milk samples from the metabolism and
radiovalidation studies resulted in different major residues.  The
petitioner proposed that this difference arose from the difference in
the dosing levels.

Based on the currently available information, the dairy cow feeding
study should have monitored for bifenazate, D3598, A1530, A1530-sulfate,
and D9569 in milk (monitoring for bifenazate, D3598, A1530, and
A1530-sulfate in tissues is acceptable).  Based on the procedure
outlined below for estimation of residues in milk and since the ruminant
metabolism study resulted in TRRs in milk of 0.047 ppm following a 10
ppm dietary burden, HED will not request a ruminant feeding study
monitoring for residues of D9569 in milk until the dietary burden is >10
ppm (highest dietary burden level in the dairy cow feeding study).
Pending the submission of these data, potential A1530-sulfate and/or
D9569 residues in milk will be estimated using the combined
bifenazate/D3598 residues from the feeding study and the 4.6x
A1530-sulfate to bifenazate/D3598 residue ratio from the metabolism
study.  HED notes that this procedure was performed for the most recent
bifenazate dietary exposure analysis (D330587, T. Bloem, 19-Jul-2006).

The metabolic routes in goats and hens were similar and proceeded via
oxidation of the hydrazine moiety of bifenazate to form D3598 which is
further degraded to D1989, D9569, A1530, and/or A1530-sulfate and to
bound residues by reaction with natural products.

There are adequate residue analytical methods for tolerance enforcement
and data collection.  High-performance liquid chromatography (HPLC)
Method UCC-D2341 is available as a primary enforcement method for
determination of the combined residues of bifenazate and its metabolite
D3598 in/or crop matrices.  The method has undergone a successful
petition method validation and has been forwarded to the Food & Drug
Administration (FDA) for inclusion in the Pesticide Analytical Manual
(PAM) Volume II as a Roman numeral method.  The limit of quantification
(LOQ) and limit of detection (LOD) of Method UCC-D2341 are 0.01 and
0.005 ppm, respectively.  In addition, a method utilizing liquid
chromatographic system with tandem mass spectrometers (LC/MS/MS) was
recently submitted as a confirmatory method (Method NCL ME 245) and has
been forwarded to FDA.

The data-collection methods used in the storage stability and magnitude
of the residue studies associated with this petition are HPLC methods
with oxidative coulometric electrochemical detection (ECD).  The
procedures of these methods are similar to the primary enforcement
method, and adequate concurrent recoveries were attained in the
magnitude of the residue studies.

There are also adequate HPLC (primary) and LC/MS/MS (confirmatory)
methods for the enforcement of tolerances for residues of bifenazate and
its regulated metabolites in livestock matrices.  Recently submitted
radiovalidation data showed inconsistent results, and the petitioner has
been requested (Memo, 7/19/06, T. Bloem, DP# 313261) to confirm the
identification of metabolite D9569 as the major residue in milk.

The requirements for Multireresidue Methods (MRMs) testing data are
fulfilled.  Bifenazate and the metabolites D3598, A1530, and
A1530-sulfate are not quantitatively recovered through the FDA MRMs.

The durations and storage conditions of samples collected from the field
trials conducted on caneberry, guava, papaya, succulent-shelled peas and
beans, and edible-podded beans are supported by adequate storage
stability data.  Since the samples of lychee fruit from the field trials
were stored frozen for up to ~10 months and residues were found to
decline in the fruit after 2 months, residues were corrected for
approximately 30% decline during storage.

An adequate dairy cattle feeding study is available.  Data from this
study indicate that the existing tolerances for milk, fat, meat, and
meat byproducts of cattle, goat, hog, horse, and sheep remain adequate
to support the expected dietary exposure from residues of bifenazate
residues in/on livestock feedstuffs resulting from the proposed uses.
Maximum theoretical dietary burdens (MTDB) of 2.8 ppm for beef cattle,
1.9 ppm for dairy cattle, and 0.30 ppm for swine were determined.  The
calculations reflect the most recent guidance from HED concerning
revisions of Table 1 Feedstuffs (October 2006).  Based on a dietary
burden of 0.38 ppm for poultry and the residues identified in the
poultry metabolism study, the proposed uses of bifenazate on the crops
addressed in this document are not expected to alter the Agency’s
previous determination that there is no reasonable expectation of finite
residues [Category 180.6(a)(3)] in poultry commodities.  Thus,
tolerances are not needed for secondary residues in poultry and eggs.

The submitted field trial data for edible-podded beans and peas
(representatives of crop subgroup 6A, edible-podded legume vegetables)
and succulent-shelled beans and lima beans (representatives of crop
subgroup 6B, succulent, shelled pea and bean) are adequate for the
purposes of tolerances in conjunction with a conditional registration
while additional residue data are generated.

No residue data were submitted to support the proposed use on
succulent-shelled soybean.  The available data from succulent pea and
bean subgroup 6B may be translated to succulent-shelled soybean.
According to an HED memorandum (B. Schneider, 11/4/04), until the
Federal Register Notice is issued revising the Crop Group Regulations to
establish the revised succulent pea and bean subgroup 6B, the tolerance
for residues in succulent-shelled soybean will be listed separately at
the same tolerance level.

The submitted field trial data for raspberry and blackberry, the
representatives of caneberry (crop subgroup 13A), are adequate.  The
available field trial data may be used to support the proposed tolerance
for residues in/on the subgroup.

No residue data were submitted to support the proposed use on wild
raspberry.  The available field trial data for Caneberry Subgroup 13A
will be translated to wild raspberry.  According to the Reviewer’s
Guide and Summary of HED ChemSAC Approvals for Amending Crop
Group/Subgroups [40 CFR §180.41] and Commodity Definitions [40 CFR
§180.1(h)], dated 6/14/06, a separate tolerance for residues in/on wild
raspberry should be listed in the appropriate section of the CFR entry
until the new crop group regulation for the Caneberry Subgroup 13A is
published.

The submitted field trial data for guava, lychee, and papaya are
adequate.  The available data may be used to support the requested uses
on guava, lychee, and papaya.  The guava data may be translated to
support the proposed uses on feijoa, jaboticaba, wax jambu, starfruit,
passionfruit, and acerola.  The lychee data may be translated to support
the proposed uses on longan, Spanish lime, rambutan, and pulasan.  The
papaya data may be translated to support the proposed uses on black
sapote, canistel, mamey sapote, mango, sapodilla, and star apple.

An adequate confined rotational crop study is available; a
limited/extensive field rotational crop study with bifenazate has not
been submitted.  HED review of the confined rotational crop study
concluded that a 30-day rotational crop restriction is appropriate for
the following reasons:  (1) application was made to bare soil; (2) total
radioactive residues (TRRs) in mature carrot planted 30 days after
treatment at 0.50 lb ai/A were <0.01 ppm (0.007 ppm); (3) TRRs in mature
lettuce planted 30 days after treatment at 0.50 lb ai/A were 0.014 ppm;
however, upon analysis, no residue >0.01 ppm was identified; and (4)
TRRs in wheat forage, wheat hay, wheat chaff, and wheat grain planted 30
days after treatment at 0.50 lb ai/A were 0.038 ppm, 0.117 ppm, 0.031
ppm, and 0.016 ppm, respectively; however, upon analysis, no residues
>0.01 ppm were identified.  Appropriate rotational crop restrictions
appear on the product label for the 50% WP (Acramite®-50WS)
formulation.  However, the product label for the 4 lb/gal FlC
formulation (Acramite®-4SC) does not specify any rotational crop
restrictions and must be revised to specify a 30-day plantback interval
(PBI).

Analytical reference standards of bifenazate and its metabolite D3598
are available at the EPA National Pesticide Standards Repository.

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

HED has examined the residue chemistry database for bifenazate.  Pending
submission of revised Sections B and F, there are no residue chemistry
issues that would preclude granting a conditional registration for use
of this miticide/insecticide on the crops/subgroup requested or the
establishment of tolerances for combined residues of bifenazate and
D3598, expressed as bifenazate, as follows:

Papaya	7.0 ppm

Star apple	7.0 ppm

Black sapote	7.0 ppm

Mango	7.0 ppm

Sapodilla	7.0 ppm

Canistel	7.0 ppm

Mamey sapote	7.0 ppm

Lychee	5.0 ppm

Longan	5.0 ppm

Spanish lime	5.0 ppm

Rambutan	5.0 ppm

Pulasan	5.0 ppm

Guava	0.90 ppm

Feijoa	0.90 ppm

Jaboticaba	0.90 ppm

Wax jambu	0.90 ppm

Starfruit	0.90 ppm

Passionfruit	0.90 ppm

Acerola	0.90 ppm

Caneberry subgroup 13A	5.0 ppm

Wild raspberry	5.0 ppm

Vegetable, legume, edible-podded, subgroup 6A	6.0 ppm

Pea and bean, succulent-shelled, subgroup 6B	0.70 ppm

Soybean, succulent-shelled	0.70 ppm

As a condition of registration, the petitioner should be required to
submit crop field trial data for the representative commodities of
edible-podded legume vegetables, subgroup 6a, (9 trials) and
succulent-shelled pea and bean, subgroup 6b, (12 trials).  The field
trials should be conducted according to the proposed use directions of
this petition (not at an exaggerated rate) and residue decline data
should be generated.

860.1200  Directions for Use

•	Label revisions are required to remove members of Legume Vegetables
and to list only members of Subgroups 6A and 6B on the proposed end-use
products.

•	The product label for the 4 lb/gal FlC formulation (Acramite®-4SC)
does not specify any rotational crop restrictions and must be revised to
specify a 30-day PBI.

860.1500 Crop Field Trials

Edible-podded Legume Vegetables (Subgroup 6A) and Succulent-shelled Pea
and Bean (Subgroup 6B):  As a condition of registration the petitioner
should be required to submit crop field trial data for the
representative commodities of edible-podded legume vegetables, subgroup
6a, (9 trials) and succulent-shelled pea and bean, subgroup 6b, (12
trials).  The field trials should be conducted according to the proposed
use directions of this petition (not at an exaggerated rate) and residue
decline data should be generated.

860.1550  Proposed Tolerances

•	The petitioner should submit a revised Section F reflecting the
recommended tolerances presented in Table 14.

A human-health risk assessment is forthcoming as a separate document.

Background

The chemical structure and nomenclature of bifenazate and its metabolite
(D3598) are presented in Table 1, and the physicochemical properties of
the technical grade of bifenazate are presented in Table 2.

-(4-methoxy[1,1′-biphenyl]-3-yl)hydrazinecarboxylate

CAS registry number	149877-41-8

End-use products (EPs)	Acramite®-50WS (50% WP; EPA Reg. No. 400-503)

Acramite®-4SC (4 lb/gal FlC; EPA Reg. No. 400-514)

Compound

Common name	None

Company experimental name	D3598

IUPAC name
isopropyl-(4-methoxy-[1,1’-biphenyl]-3-yl)diazenecarboxylate

CAS name	diazenecarboxylic acid, 2-(4-methoxy-[1,1’-biphenyl]-3-yl),
1-methylethyl ester

CAS registry number	149878-40-8

Table 2.  Physicochemical Properties of the Technical Grade of
Bifenazate.

Melting range	124-125 ºC	MRID 46064101

pH	6.78

	Density	1.19 g/cm3

	Water solubility	2.1 mg/L (20 °C)

	Solvent solubility	102 mg/mL ethyl acetate (20 °C)

	Vapor pressure	<1 x 10-8 atm M3/mole (25 °C)

	Dissociation constant, pKa	12.94 at 23 °C

	Octanol/water partition coefficient, Log(KOW)	3.4

	UV/visible absorption spectrum	Max 264 nm in water

860.1200  Directions for Use

The petitioner has submitted undated draft labels for the 50% WP
formulation (Acramite®-50 WS; EPA Reg. No. 400-503) and the 4 lb/gal
FlC formulation (Acramite®-4SC; EPA Reg. No. 400-514).  Information
pertaining to the proposed end-use products are listed in Table 3.  A
summary of the proposed use patterns is detailed in Table 4.

Table 3.   Summary of Proposed End-Use Products.

Trade Name	Reg. No.	ai (% of formulation)	Formulation Type	Target Crops
Target Pests	Label Date

Acramite®-50WS	400-503	50%	Wettable powder (WP)	Caneberry Subgroup 13A,
Wild Raspberry;

Tropical fruit:  Papaya, Star Apple, Black Sapote, Mango, Sapodilla,
Canistel, Mamey Sapote, Lychee, Longan, Spanish Lime, Rambutan, Pulasan,
Guava, Feijo, Jaboticaba, Wax Jambu, Starfruit, Passionfruit, Acerola
Mites controlled:  Bankgrass, Brown almond, Clover, European red,
McDaniel, Pacific spider, Pecan leaf scorch, Strawberry spider,
Willamette, and Two-spotted spider	undated draft label

Acramite®-4SC	400-514	43.2% (equivalent to 4 lb ai/gal)	Flowable
concentrate (FlC)	Legume Vegetables Subgroup 6A, succulent;

Beans, Subgroup 6B; Succulent-shelled soybean;

Succulent pea including succulent-shelled, edible-podded, and pigeon
Mites controlled:  Bankgrass, Brown almond, Clover, European red,
McDaniel, Pacific spider, Pecan leaf scorch, Strawberry spider,
Willamette, and Two-spotted spider	undated draft label

Table 4.  Summary of Proposed Directions for Use of Bifenazate.

Applic. Timing, Type, and Equip.	Formulation

[EPA Reg. No.]	Max. Single Applic. Rate

(lb ai/A)	Max. No. Applic. per Season	Max. Seasonal Applic. Rate

(lb ai/A)	PHI

(days)

Caneberry Subgroup 13A including:  Blackberry, Loganberry, Red and Black
Raspberry, and cultivars and/or hybrids of these

Wild Raspberry

Foliar spray

Ground	50% WP

[400-503]	0.38-0.50	1	0.50

(implied)	1

	Use Directions and Restrictions:  Application is to be made in a
minimum of 50 gal/A using ground equipment.  Application through any
type of irrigation system is prohibited.

Tropical fruit including:  Papaya, Star Apple, Black Sapote, Mango,
Sapodilla, Canistel, Mamey Sapote, Lychee, Longan, Spanish Lime,
Rambutan, Pulasan, Guava, Feijo, Jaboticaba, Wax Jambu, Starfruit,
Passionfruit, and Acerola

Foliar spray

Ground	50% WP

[400-503]	0.38-0.50	1	0.50

(implied)	1

	Use Directions and Restrictions:  Application is to be made in a
minimum of 50 gal/A using ground equipment.  Application through any
type of irrigation system is prohibited.

Legume Vegetables Subgroup 6A (succulent)

Beans Subgroup 6B

Succulent-shelled soybean

Including Bean (Lupinous) (includes grain lupin, sweet lupin, white
lupin, and white sweet lupin), Bean (Phaseolus) (includes field bean,
kidney bean, lima bean, navy bean, pinto bean, runner bean, snap bean,
tepary bean, wax bean); Bean (Vigna) (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; Lentil; Pea (Pisum) (includes dwarf pea, edible-podded pea,
English pea, field pea, garden pea, green pea, snow pea, sugar snap
pea); Pigeon pea; Soybean; Soybean (immature seed); Sword bean

Foliar spray

Ground and aerial	4 lb/gal FlC

[400-514]	0.38-0.50	1	0.50

(implied)	3

	Use Directions and Restrictions:  Application is to be made in a
minimum of 20 gal/A using ground equipment and 5 gal/A using aerial
equipment.  Application through any type of irrigation system is
prohibited.

Succulent Pea (Pea, Succulent-shelled; Pea, Edible-podded; and Pea,
Pigeon)

Including Sugar pea, Chinese pea, Pois mange tout, Snap pea, Ming pea,
Podded pea, Snow pea, China pea, Chicharo, Shi Hia wandou, Saya-endo,
Sugar snap pea, Congo pea, No-eye pea, Red gram, Arher, Grandul,
Gandules, Dhal, Toor, Gunds pea, Porto Rico pea, Urher Gandul, Guandu,
Pois-d’angole, Gungo pea

Foliar spray

Ground and aerial	4 lb/gal FlC

[400-514]	0.38-0.50	1	0.50

(implied)	3

	Use Directions and Restrictions:  Application is to be made in a
minimum of 20 gal/A using ground equipment and 5 gal/A using aerial
equipment.  Application through any type of irrigation system is
prohibited.

The following rotational crop restriction is specified for the 50% WP
formulation:  Do not plant another crop within 30 days after last
Acramite®-50WS application due to chances of bifenazate residues
showing up in rotational crops.  Rotational crop restrictions do not
appear on the 4 lb/gal FlC formulation (Acramite®-4SC).

Conclusions.  The proposed use directions are adequate to allow
evaluation of the residue data relative to the proposed use.  However,
label revisions are required to remove members of Legume Vegetables and
to list only members of Subgroups 6A and 6B on the proposed end-use
products.  Additionally, the product label for the 4 lb/gal FlC
formulation (Acramite®-4SC) does not specify any rotational crop
restrictions and must be revised to specify a 30-day PBI.

860.1300 Nature of the Residue - Plants

Residue Chemistry Memo; DP# 324430, 7/19/06, T. Bloem (Discussion of
Radish Metabolism Study)

Residue Chemistry Memo; DP# 276801, 8/16/01, T. Bloem (HED MARC Memo of
Residues of Concern)

Residue Chemistry Memo; DP# 276623, 7/31/01, T. Bloem (MARC Briefing
Document)

The qualitative nature of the residue in plants is adequately understood
based on acceptable studies with apple, orange, and cotton.  A briefing
document, summarizing the salient features of these studies, was
presented to the MARC. The MARC concluded that for tolerance expression
and risk assessment purposes, the residues of concern in crops are
bifenazate and its metabolite D3598.

The metabolic routes in all crops were similar with major residues being
comprised of bifenazate and D3598.  The metabolic route in tested plants
proceeded via oxidation of the hydrazine moiety of bifenazate to form
D3598 which is further degraded to D1989, D9963, D4642, and/or A1530 and
to bound residues by reaction with natural products.  The HED MARC
discussed the possible formation of hydrazine in plants and concluded
that formation of hydrazine is unlikely due to the oxidation of the
parent to the conjugated diazene.  The MARC suggested that if the
petitioner submits additional metabolism studies, the presence of
biphenyl hydrazine should be monitored as a confirmatory measure.

Subsequent to the MARC decision, a radish metabolism study was
submitted.  Radish plants were treated with single spray application of
bifenazate at 0.375 or 0.75 lb ai/A (soil was added to cover exposed
root prior to application), and mature root and top samples were
harvested 7 days after application (TRRs; top - 13.0 ppm (0.375 lb ai/A)
and 26.4 ppm (0.75 lb ai/A); root - 0.0023 ppm (0.375 lb ai/A) and
0.0043 ppm (0.75 lb ai/A)).  No further analytical work was performed
in/on the radish root samples since the TRRs were <0.01 ppm.  Analysis
of the radish tops indicated that bifenazate and D3598 were the major
residues.  Hydroxylated D3598 and D2303 were also identified; biphenyl
hydrazine was included as a reference standard but was not identified.

860.1300 Nature of the Residue - Livestock

Residue Chemistry Memo; DP# 276801, 8/16/01, T. Bloem (HED MARC Memo of
Residues of Concern)

The nature of the residue in livestock is adequately understood based on
studies with lactating goats and laying hens.  The HED MARC has
determined that for tolerance expression and risk assessment purposes,
the residues of concern in livestock tissue (excluding fat), eggs, and
milk are bifenazate and the metabolites D3598 (expressed as bifenazate),
A1530, and A1530-sulfate (expressed as A1530).  The residues of concern
for tolerance expression and risk assessment purposes in fat are
bifenazate and D3598 (expressed as bifenazate).  Based on the ruminant
metabolism (goat; 10 ppm dietary burden) and the dairy cow feeding study
(1 ppm, 3 ppm, and 10 ppm dietary burdens), the HED MARC determined that
for the tolerance expression and risk assessment purposes the residues
of concern in milk are bifenazate, D3598 (expressed as bifenazate),
A1530, and A1530-sulfate (expressed as A1530; D276801, T. Bloem,
16-Aug-2001).  A milk tolerance of 0.02 ppm (LOQ tolerance) is currently
established and is based on the 6.99 ppm dairy cattle dietary burden
(D290053, T. Bloem, 29-May-2003; D324430, T. Bloem, 19-July-2006) and
the dairy cow feeding study which resulted in residues of
bifenazate/D3598 and A1530/A1530-sulfate of <0.01 ppm in all of the
whole milk samples (D277089, T. Bloem, 16-Aug-2001; analytical method
does not distinguish between D3598 and bifenazate nor A1530 and
A1530-sulfate).

Subsequent to the MARC decision, the petitioner submitted a
radiovalidation study for the livestock enforcement method.  In order to
generate samples for this study, a goat was dosed with radiolabeled
bifenazate (20 ppm dietary burden; 46691301.der.wpd).  Milk, fat, and
liver samples were collected and analyzed.  Contrary to the ruminant
metabolism study which indicated that A1530-sulfate was the major
residue in milk (41% TRR; D9569 was a minor residue), the
radiovalidation study indicated that D9569 was the major residue (24%
TRR; A1530-sulfate was a minor residue); no differences in the fat and
liver metabolic profile were indicated.  The petitioner has submitted
data confirming the identify of A1530-sulfate in the ruminant metabolism
study (isolated peak degraded to A1530 upon treatment with
glucuronidase/sulfatase) and confirming the identify of D9569 in the
radiovalidation study (D9569 identified using two methods; MRID
47058901).  Therefore, the milk samples from the metabolism and
radiovalidation studies resulted in different major residues.  The
petitioner proposed that this difference arose from the difference in
the dosing levels.

Based on the currently available information, the dairy cow feeding
study should have monitored for bifenazate, D3598, A1530, A1530-sulfate,
and D9569 in milk (monitoring for bifenazate, D3598, A1530, and
A1530-sulfate in tissues is acceptable).  Based on the procedure
outlined below for estimation of residues in milk and since the ruminant
metabolism study resulted in TRRs in milk of 0.047 ppm following a 10
ppm dietary burden, HED will not request a ruminant feeding study
monitoring for residues of D9569 in milk until the dietary burden is >10
ppm (highest dietary burden level in the dairy cow feeding study).
Pending the submission of these data, potential A1530-sulfate and/or
D9569 residues in milk will be estimated using the combined
bifenazate/D3598 residues from the feeding study and the 4.6x
A1530-sulfate to bifenazate/D3598 residue ratio from the metabolism
study.  HED notes that this procedure was performed for the most recent
bifenazate dietary exposure analysis (D330587, T. Bloem, 19-Jul-2006).

The metabolic routes in goats and hens were similar and proceeded via
oxidation of the hydrazine moiety of bifenazate to form D3598 which is
further degraded to D1989, D9569, A1530, and/or A1530-sulfate and to
bound residues by reaction with natural products.

860.1340 Residue Analytical Methods

Plant Commodities

DER Reference:	47016703.der.doc (lychee).

Residue Chemistry Memo; DP# 313261, 7/19/06, T. Bloem (Confirmatory
enforcement method).

Residue Chemistry Memo; DP# 328814, 5/17/06, T. Bloem (Letter to FDA for
inclusion of confirmatory

enforcement method in PAM Volume II).

Residue Chemistry Memo; DP# 281973, 8/29/02, T. Bloem (Letter to FDA for
inclusion of primary enforcement

method in PAM Volume II).

Residue Chemistry Memo; DP# 277089, 8/16/01, T. Bloem (Primary
enforcement method).

Enforcement methods:  HPLC Method UCC-D2341 is available as a primary
enforcement method for the combined residues of bifenazate and its
metabolite D3598 in/or plant matrices.  The method has undergone a
successful petition method validation (PMV) and has been forwarded to
FDA for inclusion in PAM Volume II as a Roman Numeral method.  The LOQ
and LOD of Method UCC-D2341 are 0.01 and 0.005 ppm, respectively.  In
addition, LC/MS/MS Method NCL ME 245 was recently submitted as a
confirmatory method and has been forwarded to FDA.  The LC/MS/MS method
includes instructions for monitoring two transitional ions (primary
transition for quantitation and a secondary transition ion for
confirmation).

Data-collection methods:  The data-collection methods used for the
analysis of samples taken from supporting storage stability and
magnitude of the residue studies are HPLC/ECD methods.  Descriptions and
validation data for a working HPLC method were submitted (MRID
47016703), and the Executive Summary of the DER is appended below.

IR-4 has submitted a method entitled, “Determination of Combined
Bifenazate and D3598 Residues in Lychee.”  This method was used to
determine combined residues of bifenazate and its metabolite D3598 in/on
samples of lychee from the storage stability and crop field trial
studies associated with the subject petition.  Briefly, homogenized
samples were extracted twice using acetonitrile (ACN) containing 0.1%
acetic acid.  The combined extracts were filtered, brought up to volume
with ACN, and partitioned with methylene chloride and 2% aqueous sodium
sulfate.  The methylene chloride phase was evaporated to near dryness,
reconstituted in ACN and cleaned up using an amino propyl extraction
column.  The resulting eluate was evaporated to near dryness, and
residues were reconstituted in HPLC mobile phase (ACN/sodium acetate pH
4 buffer/acetic acid) with 0.1% ascorbic acid to convert residues of
metabolite D3598 to bifenazate.  After at least 2 hours of incubation,
the samples were quantitated as bifenazate by reversed-phase HPLC/ECD.
The LOD and validated LOQ are 0.005 and 0.01 ppm, respectively, for both
analytes in/on samples of lychee.

Method validation data for the HPLC working method demonstrated adequate
method recoveries of residues of bifenazate and D3598 from lychee.
Following fortification of samples with each analyte at 0.010 ppm, 0.1
ppm, and 1.0 ppm, the ranges of recoveries (and CVs) of bifenazate and
metabolite D3598 were 75.8-117 % (13%) and 77.06-117.3% (17%),
respectively, for lychee.    SEQ CHAPTER \h \r 1 The fortification
levels used in method validation were not adequate to bracket expected
residue levels; however, additional method validation at 3 ppm was
performed for the analysis of the lychee crop field trial data (refer to
DER for MRID 47016701).  Adequate recoveries of bifenazate and D3598
were obtained from lychee fortified with each analyte at 3.0 ppm.

Conclusions:  The methods used in the magnitude of the residue studies
were adequately validated and are appropriate for data collection
purposes.  These methods are similar to the current analytical
enforcement method which does not distinguish between bifenazate and
metabolite D3598.  Since the procedures are similar and adequate
concurrent recoveries were attained in the magnitude of the residue
studies, HED concludes that the current enforcement method is
appropriate for enforcement of the tolerances associated with this
petition.

Livestock Commodities

Residue Chemistry Memo; DP# 313261, 7/19/06, T. Bloem (Radiovalidation
and confirmatory enforcement method)

Residue Chemistry Memo; DP# 281973, 8/29/02, T. Bloem (Letter to FDA for
inclusion of primary enforcement

method in PAM Volume II).

Residue Chemistry Memo; DP# 277089, 8/16/01, T. Bloem (Primary
enforcement method)

HPLC methods with fluorescence detection or oxidative coulometric
electrochemical detection are available as primary methods for the
enforcement of tolerances for residues of bifenazate and its regulated
metabolites in livestock matrices.  The methods have undergone a
successful PMV and have been forwarded to FDA for inclusion in PAM
Volume II.  In addition, the LC/MS/MS Method NCL ME 259 was recently
submitted as a confirmatory method, and this method was also forwarded
to FDA.  The LC/MS/MS method includes instructions for monitoring two
transitional ions (primary transition for quantitation and a secondary
transition ion for confirmation).

860.1360 Multiresidue Methods

Residue Chemistry Memo; PP#5E6992; DP# 324430, 7/19/06, T. Bloem.

HED previously reviewed MRM data for bifenazate, D3598, A1530, and
A1530-sulfate the data were submitted to the FDA.  These data indicate
that bifenazate, D3598, A1530, and A1530-sulfate are not quantitatively
recovered through the FDA MRMs.

860.1380 Storage Stability

DER Reference:	47016702.der.doc (lychee).

Residue Chemistry Memo; DP# 324430, 7/19/06, T. Bloem.

Residue Chemistry Memo; DP#s 297604 and 318105, 7/12/06, T. Bloem.

Residue Chemistry Memo; DP# 290053, 5/29/03, T. Bloem.

Residue Chemistry Memo; DP# 277089, 8/16/01, T. Bloem.

Residue Chemistry Memo; DP# 276801, 8/16/01, T. Bloem.

Residue Chemistry Memo; DP# 276623, 7/31/01, T. Bloem.

Table 5 is a summary of the currently available storage stability data.
Some of the previous storage stability studies were conducted for only
bifenazate (bifenazate and D3598 are the residues of concern for risk
assessment and tolerance enforcement).  D3598 was not a major residue
identified in the plant metabolism studies ((6% TRR) and was included as
a residue of concern only because the analytical method does not
distinguish between bifenazate and D3598.

Table 5.   Storage Stability Data.

Crop	Residue	Interval	Reference

Cantaloupe	Bifenazate	2 months	DP#s 297604 and 318105, T. Bloem, 7/12/06

Tomato	Bifenazate	5 months

	Tomato paste	Bifenazate	1 month

	Tomato puree	Bifenazate	1 month

	Mint foliage	Bifenazate	2.5 months

	Pepper	Bifenazate	5 months

	Apple	Bifenazate and D3598	42 days	DP# 277089, T. Bloem, 8/16/01

Grape	Bifenazate and D3598	7 days

	Peach	Bifenazate and D3598	56 days - bifenazate

14 days - D3598

	Cottonseed	Bifenazate and D3598	<21 days1

	Cotton gin byproducts	Bifenazate and D3598	<44 days1

	Cottonseed hulls	Bifenazate and D3598	52 days

	Cottonseed oil	Bifenazate and D3598	28 days

	Cottonseed meal	Bifenazate and D3598	43 days - bifenazate

<43 days - D35981

	Potato	Bifenazate	<7 days	DP# 324430, T. Bloem, 7/19/06

Lychee	Bifenazate	<2 months	47016702.der.doc

1  shortest interval tested

In conjunction with the current petition, IR-4 has submitted the results
of a storage stability study (MRID 47016702) with residues of bifenazate
in/on lychee fruits.  Untreated samples of lychee fruits were fortified
with bifenazate at 0.1 ppm.  Samples were placed in frozen storage at
-19.2 to -27.0 ºC and analyzed at storage intervals of 0, 0.25, 1, 2,
5, 8, and 10 months.  The results indicate that under these conditions,
residues of bifenazate generally declined in lychee fruit beginning at 2
months of storage and leveled out at ~30% decline after 8-10 months of
storage.  Samples of lychee fruit were analyzed for residues of
bifenazate using an HPLC/ECD method.  This method is adequate for data
collection based on acceptable method recoveries.  The reported LOD and
validated LOQ are 0.005 and 0.01 ppm, respectively, for bifenazate in/on
samples of lychee.

Sample storage conditions and durations

The storage durations and conditions of samples from the crop field
trials submitted to support this petition are presented in Table 6.

Table 6.   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

Bean, Succulent-shelled

(lima bean)	-29.3 to -4.7	6-11 days (<1 month)	The available storage
stability data indicate the bifenazate and/or D3598 are not stable in/on
some matrices when stored frozen for intervals of <30 days (DP# 277089,
T. Bloem, 8/16/01).  Since the maximum storage interval for these
samples is 11 days, storage stability data are not required to cover
this interval.

Bean, Succulent-shelled	-26.0 to -16.6	6-9 days (<1 month)

	Bean, Edible-podded	-26.0 to -16.6	5-10 days

(<1 month)

	Caneberry	-28.9 to -18.7	5-13 days

(<1.0 month)	The available storage stability data (refer to PP#0F6108;
DP# 277089, 8/16/01, T. Bloem),   SEQ CHAPTER \h \r 1 demonstrate that
residues of bifenazate and D3598 are stable in/on frozen whole peach for
up to 56 days and 14 days, respectively, and that residues of bifenazate
and D3598 are relatively stable in peach homogenate stored frozen for up
to 42 days.

In addition, storage stability data (refer to DER for MRID 47016702)
indicate that residues of bifenazate declined on lychee fruit after 2
months of storage and leveled out ~30% decline after 8-10 months.  Since
the maximum storage interval for these samples is 23 days, storage
stability data are not required to cover this interval.

Guava	-26.8 to -19.0	16-23 days

(<1.0 month)

	Papaya	-30.4 to -15.8	8-11 days

(<1.0 month)

	Lychee fruit	-28.9 to -19.9	297-308 days

(9.8-10.1 months)	Storage stability data (refer to DER for MRID
47016702) indicate that residues of bifenazate declined on lychee fruit
after 2 months of storage and leveled out ~30% decline after 8-10
months.

Conclusions.  The storage conditions and durations of samples from the
caneberry, guava, and papaya field trials are supported by adequate
storage stability data.  Since the samples of lychee fruit from the
field trials were stored frozen for up to ~10 months, residues were
corrected for approximately 30% decline during storage.  The maximum
storage interval samples from the succulent-shelled and edible-podded
bean field trials was 11 days.  As samples were stored <30 days, storage
stability data are not required to cover this interval.

860.1480 Meat, Milk, Poultry, and Eggs

Residue Chemistry Memo; DP# 277089, 8/16/01, T. Bloem, (PP#0F06108)

Residue Chemistry Memo, DP# 324430, 7/19/06, T. Bloem, (PP#5E6992)

A tolerance of 0.1 ppm has been established for the combined residues of
bifenazate and D3598 (expressed as bifenazate) in the fat of cattle,
goat, hog, horse, and sheep [40 CFR §180.572(a)(1)].  A tolerance of
0.02 ppm has been established for the combined residues of bifenazate,
D3598 (expressed as bifenazate), A1530, and A1530-sulfate (expressed as
A1530) in the milk, and meat and meat byproducts of cattle, goat, hog,
horse, and sheep [40 CFR §180.572(a)(2)].

Livestock dietary burdens

There are livestock feedstuffs associated with the proposed uses in this
petition.  These feedstuffs include soybean commodities derived from the
proposed use on succulent-shelled soybean.  In addition, feedstuffs are
associated with previously approved uses of bifenazate on cotton, apple,
and potato.  The maximum theoretical dietary burdens of bifenazate to
livestock are calculated in Table 7, and the calculations made reflect
the most recent guidance from HED concerning revisions of feedstuff
percentages in Table 1.  However, HED notes that the diets should be
consider worst-case in terms of residue exposure and may not be
nutritionally sound for livestock.  The dietary burdens are 2.8 ppm for
beef cattle, 1.9 ppm for dairy cattle, 0.30 ppm for swine, and 0.38 ppm
for poultry.

Table 7.   Livestock Dietary Burdens for Bifenazate to Livestock.

Feedstuff	% Dry Matter 1	% Diet1	Reassessed Tolerance (ppm)	Dietary
Contribution (ppm)2

Beef Cattle

Cotton gin byproducts	90	5	20	1.11

Cotton hulls	90	15	0.50	0.083

Cotton seed	15	25	0.50	0.14

Wet apple pomace	40	20	1.2	1.20

Soybean seed3	89	15	1.5	0.25

Untreated	NA	20	NA	--

  TOTAL BURDEN	--	100	--	2.8

Dairy Cattle

Cotton seed	88	25	0.50	0.14

Cotton hulls	90	15	0.50	0.083

Cotton meal	89	15	0.50	0.084

Wet apple pomace	40	10	1.2	0.30

Almond hulls	90	5	15	0.83

Soybean seed	89	15	1.5	0.25

Untreated	NA	15	NA	--

  TOTAL BURDEN

100	--	1.9

Swine

Untreated	NA	80	NA	--

Soybean meal	92	20	1.5	0.30

  TOTAL BURDEN	--	100

0.30

Poultry

Untreated	NA	75	NA	--

Soybean meal	92	25	1.5	0.375

  TOTAL BURDEN	--	100

0.38

1  Revision of feedstuffs in OPPTS 860.1000 Table 1 referenced as
“Table 1 Feedstuffs (October 2006)”

2  Contribution = ([tolerance /% DM] X % diet) for beef and dairy
cattle; contribution = ([tolerance] X % diet) for poultry and swine.

3  Tolerance-level for residues in soybean seed is as per the
established tolerance in conjunction with a Section 18 Emergency
Exemption (40 CFR §180.572(b).

Livestock Feeding Studies

Residue Chemistry Memo, DP# 277089, T. Bloem, 8/16/01 (PP#0F06108)

  SEQ CHAPTER \h \r 1 A dairy cattle feeding study was reviewed in
PP#0F06108.  Cattle were fed 1, 3, and 10 ppm bifenazate in the diet for
28 consecutive days.  The results are shown below in Table 8.

Table 8.   Bifenazate Residues in Dairy Cattle Commodities Following
Oral Administration of Bifenazate.

Matrix	Dosing Group	Residues (ppm)

Bifenazate/D35981	A1530/A15301

Milk	10 ppm (day 1-28) 2	<0.01	<0.01

Butter fat	10 ppm (day 20)	0.01	<0.01

	10 ppm (day 28)	0.03	<0.01

	3 ppm (day 20)	<0.01	<0.01

	3 ppm (day 28)	<0.01	<0.01

Skim milk	10 ppm (day 20)	<0.01	<0.01

	10 ppm (day 28)	<0.01	<0.01

Loin muscle	10 ppm	<0.01	<0.01

Round muscle	10 ppm	<0.01	<0.01

Liver	10 ppm	<0.01	<0.01

Kidney	10 ppm	0.01	<0.01

Omental fat 3	10 ppm	0.07	<0.01

	3 ppm	0.02	<0.01

	1 ppm	<0.01	<0.01

Perirenal fat 3	10 ppm	0.10	<0.01

	3 ppm	0.03	<0.01

	1 ppm	<0.01	<0.01

1  Combined bifenazate/D3598 expressed as bifenazate; combined
A1530/A1530-S expressed as A1530.

2  Only 10 ppm milk samples were analyzed and all were <LOQ (LOQ = 0.01
ppm).

3  Fat samples were not analyzed for A1530-sulfate.

Conclusions:  Based on the dietary exposure levels and the residue data
from an available ruminant feeding study, the existing bifenazate
tolerances for milk, fat, meat, and meat byproducts of ruminants are
adequate to support the proposed uses.  Based on a dietary burden of
0.38 ppm for poultry and the residues identified in the poultry
metabolism study, HED concludes that the proposed uses of bifenazate on
the crops 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.  Thus, tolerances are not
required for residues in/on poultry and eggs.

860.1500 Crop Field Trials

Edible-podded Legume Vegetables (Subgroup 6A) and

Succulent-shelled Pea and Bean (Subgroup 6B)

DER Reference:	47016705.der.doc (edible-podded and succulent-shelled
beans)

DER Reference:	47016706.der.doc (lima bean)

Residue Chemistry Memo; DP# 324430, 7/19/06, T. Bloem

IR-4 submitted field trial data for bifenazate on edible-podded beans, a
representative of crop subgroup 6A (edible-podded legume vegetables) and
succulent-shelled beans, a representative of crop subgroup 6B
(succulent, shelled pea and bean).  Eleven bean field trials were
conducted in the U.S. during the 2002 growing season.

Each field trial consisted of one untreated plot and one treated plot.
Two foliar directed or broadcast applications of the 4 lb/gal SC
formulation [equivalent to a FlC formulation] of bifenazate was made to
beans at ~0.75 lb ai/A/application, with 13- to 15-day RTIs, for a total
rate of ~1.5 lb ai/A (3x the maximum proposed seasonal rate of 0.5 lb
ai/A).  All applications were made using ground equipment in 20-42
gal/A.  An adjuvant was not added to the spray mixture for any
applications.  Mature beans were harvested 2-4 days after the second
application.

The succulent-shelled and edible-podded bean samples were analyzed for
combined residues of bifenazate and its metabolite D3598 using a
HPLC/ECD method.  The validated LOQ was 0.01 ppm for both analytes.  The
calculated LOD was 0.005 ppm for bifenazate and D3598 in/on samples of
beans.  This method is adequate for data collection based on acceptable
method validation and concurrent method recoveries from beans fortified
at 0.01-5.0 ppm.

A summary of residue data from the edible-podded bean and
succulent-shelled bean field trials is presented in Table 9.    SEQ
CHAPTER \h \r 1 The maximum combined residue of bifenazate and D3598 was
0.178 ppm in/on succulent-shelled beans and 1.989 ppm in/on
edible-podded beans harvested 2-4 days after the second application.

No residue decline data were generated with the study.

Succulent-Shelled Bean (Lima Bean)

IR-4 submitted field trial data for bifenazate on lima beans, a
representative of crop subgroup 6B (succulent, shelled pea and bean).
Two field trials were conducted on lima beans in Zone 2 (GA and MD) in
the U.S. during the 2003 growing season.

Each field trial consisted of one untreated plot and one treated plot.
Two foliar directed applications of the 4 lb ai/gal SC formulation
[equivalent to a flowable concentrate (FlC) formulation] of bifenazate
was made to lima beans at ~0.75 lb ai/A/application, with 8- to 16-day
RTIs, for a total rate of ~1.5 lb ai/A (3x the maximum proposed seasonal
rate of 0.5 lb ai/A).  All applications were made using ground equipment
in 34-49 gal/A.  An adjuvant was not added to the spray mixture for any
applications.  Mature lima beans were harvested 2-3 days after the
second application.

The lima bean samples were analyzed for combined residues of bifenazate
and its metabolite D3598 using a HPLC/ECD method.  The validated LOQ was
0.01 ppm for each analyte.  The LOD was 0.005 ppm for both analytes.
This method is adequate for data collection based on acceptable method
validation and concurrent method recoveries from beans fortified at
0.01-5.0 ppm.

A summary of residue data from the succulent-shelled bean (lima bean)
field trials is presented in Table 9.    SEQ CHAPTER \h \r 1 The maximum
combined residue of bifenazate and D3598 was 0.262 ppm in/on lima beans
harvested 2-3 days after the second application.

No residue decline data were generated with the study.

Table 9.   Summary of Residue Data from Edible-Podded and
Succulent-Shelled Bean and Pea Field Trials with Bifenazate.

Commodity

(MRID)	Total Applic. Rate

lb ai/A	PHI (days)	Combined Bifenazate/D3598 Residue Levels (ppm) 1

	n	Min.	Max.	HAFT2	Mean	Std. Dev.

Proposed Use Pattern:  Single foliar spray of the 4 lb/gal FlC
formulation at 0.38-0.50 lb ai/A, 3-day PHI.

Edible-Podded Bean and Pea

Edible-podded bean (47016705)	1.483-1.537	2-4	12	0.152	1.989	1.789	1.010
0.632

Edible-podded pea (46651703) 3	2 x 0.75	2-4	10	0.91	3.74	3.08	1.99	0.99

Succulent-Shelled Bean and Pea

Succulent-shelled bean

(47016705)	1.480-1.513	2-4	9	0.017	0.178	0.145	0.088	0.059

Succulent-shelled lima bean

(47016706)	1.508-1.518	2-3	4	0.046	0.262	0.222	0.141	0.10

Succulent-shelled pea

(46651703) 3	2 x 0.75	2-4	12	0.028	0.173	0.132	0.060	0.043

1  Residues were quantitated/reported as bifenazate equivalents.

2  HAFT = Highest-Average Field Trial.

3  Edible-podded and succulent-shelled pea data reviewed in conjunction
with PP#5E6992 (refer to DP# 324430, 7/19/06, T. Bloem).

Conclusions.  The submitted residue data for succulent-shelled bean and
pea and edible-podded bean and pea are inadequate because the field
trials do not reflect the proposed use pattern (trials were conducted at
an exaggerated rate, 3x the maximum proposed seasonal rate).
Additionally, residue decline data were not submitted.  IR-4 has
previously submitted residue data for bifenazate on edible-podded pea
and succulent-shelled pea in PP#5E6992 (Memo, 7/19/2006, T. Bloem, DP#
324430).  These studies were also conducted with application rates 1.5x
the single application rate and 3x the seasonal application rate.
Therefore, these data are not indicative of the magnitude of the residue
following application at the proposed rate.  It is noted that the
previous petition (PP#5E6992) required a full set of succulent-shelled
pea and edible-podded pea field trial data conducted at the proposed 1x
rate (Memo, 7/19/06, T. Bloem, DP#324430).

HED will use the submitted data to establish tolerances in conjunction
with a conditional registration while additional residue data are
generated.  HED concludes that there are no residue chemistry issues
that would preclude the establishment of tolerances for combined
residues of bifenazate and D3598 in/on succulent garden-pea and
edible-podded pea at 0.20 ppm and 4.0 ppm, respectively, in conjunction
with a conditional registration while additional residue chemistry data
are generated.  The residue data for edible-podded bean and
succulent-shelled bean 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.

Currently, the established tolerance is 4.0 ppm for residues in/on
edible-podded succulent pea; the tolerance spreadsheet recommends a
tolerance for residues at 6.0 ppm in/on edible-podded bean.  The
bifenazate residues do not vary by a factor of 5x between edible-podded
bean and edible-podded pea.  HED concludes there are no residue
chemistry issues that preclude the establishment of tolerances for
combined residues of bifenazate and D3598 in/on edible-podded beans,
subgroup 6A, in conjunction with a conditional registration while
additional residue data at the proposed 1x rate are generated.  This
tolerance level recommendation is higher than the level (4.0 ppm)
proposed by the petitioner.  Thus, a revised Section F is required.

Currently, the established tolerance is 0.20 ppm for combined residues
in/on succulent garden pea; the tolerance spreadsheet recommends a
tolerance of 0.70 ppm for residues in/on succulent-shelled bean.  The
bifenazate residues do not vary by a factor of 5x between
succulent-shelled bean and pea.  HED concludes there are no residue
chemistry data requirements that would preclude the establishment of a
tolerance for residues of bifenazate and D3598 in/on subgroup 6B at 0.70
ppm based on the residue data from succulent-shelled bean, in
conjunction with a conditional registration while additional residue
data at the proposed 1x rate are generated.  This tolerance level
recommendation is higher than the level (0.3 ppm) proposed by the
petitioner.  Thus, a revised Section F is required.

The issue of using exaggerated rate data for bifenazate was taken to the
HED Chemistry Advisory Council (ChemSAC).  The following are the
ChemSAC’s conclusions (Minutes of 31-October-2007 meeting, dated:
14-November-2007)

From the above data, the SAC concluded that residues in the crops at
harvest from the earlier application can not be dismissed as negligible.
 While the submitted data represent an overestimate of the residues
expected from the proposed single application, the degree of
exaggeration can not be determined.  The use of the proportionality
concept to adjust residues downward is not considered appropriate since
the data include more applications than the desired use.  The SAC
recommends that the data as generated be used to determine the tolerance
levels in spite of that data exaggerating the expected residues.  The
team should provide characterization of the exaggeration in their
assessment.  Provided that a safety finding can be made to establish the
tolerances, the SAC further recommends that the registration of these
uses be conditioned upon submission of field trials reflecting the
proposed single application.  Such data are likely to show that the
tolerances will need to be lowered.  A major factor in the
recommendation for the additional data is the risk situation for
bifenazate.  The last risk assessment showed 94% of the chronic PAD with
a fair degree of refinement (average % crop treated for many crops;
average field trial residues for high consumption commodities such as
peaches, tomatoes, and soybeans).

As a condition of registration the petitioner should be required to
submit crop field trial data for the representative commodities of
edible-podded legume vegetables, subgroup 6a, (9 trials) and
succulent-shelled pea and bean, subgroup 6b, (12 trials).  The field
trials should be conducted according to the proposed use directions of
this petition (not at an exaggerated rate) and residue decline data
should be generated.

The current chronic dietary exposure analysis (Memo, pending, W.D.
Wassell) shows that (47% of the cPAD is utilized for children 1 to 2
years of age (the most highly exposed population).  This analysis is
partially refined with anticipated residue estimates (ARs) utilized for
squash (winter and summer), peach, tomato and milk.  Based upon a
critical-commodity analysis conducted in Dietary Exposure Evaluation
Model - Food Consumption Intake Database (DEEM-FCID(, ver. 2.03), the
major contributors to the risk for children 1 to 2 years old were
succulent-shelled peas and beans, succulent or dried-legume vegetables,
milk, and edible-pod legume vegetables.

Soybean, Succulent-Shelled

No residue data were submitted to support the proposed use on
succulent-shelled soybean.  The available data from succulent pea and
bean subgroup 6B may be translated to succulent-shelled soybean.
According to an HED memorandum from B. Schneider, dated 11/4/04 until
the Crop Group Regulations are revised, a tolerance for residues in/on
succulent-shelled soybean will be listed separately at the same
tolerance level of subgroup 6B.  HED is recommending a tolerance of 0.7
ppm for residues of bifenazate in/on subgroup 6B based on the residue
data from succulent-shelled bean.  This tolerance level recommendation
is higher than the level (0.3 ppm) proposed by the petitioner.  Thus, a
revised Section F is required.

Caneberry (Subgroup 13A)

DER Reference:	47016704.der.doc (caneberry)

IR-4 has submitted field trial data for bifenazate on raspberry and
blackberry, the representatives of caneberry (crop subgroup 13A).  Eight
field trials were conducted on caneberry in the U.S. and Canada during
the 2004-2005 growing season.  Six raspberry trials were conducted in
Zones 2 (NJ; 1 trial), 10 (CA; 2 trials), 12 (BC; 2 trials), and 5B (QC;
1 trial).  Two blackberry trials were conducted in Zone 12 (OR; 2
trials).

Each field trial consisted of one untreated plot and one treated plot.
Two foliar-directed applications of a 50% WP formulation of bifenazate
was made to caneberry at ~0.5 lb ai/A/application, with 29- to 35-day
RTIs, for a total rate of ~1.0 lb ai/A (2x the maximum proposed seasonal
rate of 0.5 lb ai/A).  All applications were made using ground equipment
in ~21-84 gal/A.  A crop oil concentrate was added to the spray mixture
with the exception of one trial.  Mature raspberry and blackberry were
harvested on the day of the second application, after the test substance
had dried.

The harvested caneberry samples were analyzed for combined residues of
bifenazate and its metabolite D3598 using an HPLC/ECD method.  The
validated LOQ was 0.01 ppm for each analyte.  The LOD was 0.005 ppm for
both analytes in/on samples of caneberry.  This method is adequate for
data collection based on acceptable method validation and concurrent
method recoveries from caneberry fortified at 0.01-5.0 ppm.

A summary of residue data from the caneberry field trials is presented
in Table 10.    SEQ CHAPTER \h \r 1 The maximum combined residues of
bifenazate and D3598 were 4.625 ppm in/on caneberry harvested on the day
of the second application, after the test substance had dried.

Table 10.   Summary of Residue Data from Caneberry Field Trials with
Bifenazate.

Crop matrix	Total Applic. Rate

(lb ai/A)	PHI (days)	Combined Bifenazate/D3598 Residue Levels (ppm) 1

	n	Min.	Max.	HAFT2	Mean	Std. Dev.

Proposed Use Pattern:  Single foliar spray of the 50% WP formulation at
0.38-0.50 lb ai/A, 1-day PHI

Caneberry	0.99-1.06	0	16	1.248	4.625	3.553	2.165	0.918

1  Residues were quantitated/reported as bifenazate equivalents.

2  HAFT = Highest-Average field trial result.

No residue decline data were generated with the study.

Conclusions.  The submitted residue data for caneberry are adequate even
though the trials were conducted at an exaggerated rate.  While the
submitted data for caneberries represent an overestimate of the residues
expected from the proposed single application, the degree of
exaggeration is less than that of the bean and peas field trials.  In
the caneberry trials, the application just prior to harvest was at the
proposed 1x rate and for the beans and peas trials the application just
prior to harvest was 1.5x the proposed rate.  Additionally, caneberries
do not contribute significantly to the dietary risk, the submitted data
will be used to support the proposed tolerance and additional field
trial data will not be required for caneberries.  Although the locations
of the field trials conducted for caneberries (blackberry and raspberry)
are not in strict accordance with OPPTS Guideline 860.1500, the total
number of field trials is in accordance with the guideline.

The field trial data for caneberries 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.  The tolerance spreadsheet recommends
an individual tolerance of 5.0 ppm for residues in/on caneberry.  HED
concludes there are no residue chemistry data requirements that would
preclude the establishment of a tolerance for residues of bifenazate and
D3598 in/on caneberries , subgroup 13A at 5.0 ppm.  The recommended
tolerance level is slightly lower than the level (6.0 ppm) proposed by
the petitioner.  Thus, a revised Section F is required that reflects
this determination.

Wild Raspberry

No residue data were submitted to support the proposed use on wild
raspberry.  Wild raspberry was listed by the petitioner in its proposed
label with the caneberry subgroup 13A.  According to the Reviewer’s
Guide and Summary of HED ChemSAC Approvals for Amending Crop
Group/Subgroups [40 CFR 180.41] and Commodity Definitions [40 CFR
180.1(h)], dated 6/14/06, a separate tolerance for wild raspberry should
be listed in the appropriate section of the CFR entry until the new crop
group regulation for the caneberry subgroup 13A is published.

The available field trial data for the caneberry subgroup 13A will be
translated to wild raspberry. HED is recommending a tolerance of 5.0 ppm
for combined residues of bifenazate and D3598 in/on subgroup 13A based
on residue data from blackberry and raspberry.  This recommendation is
slightly lower than the level (6.0 ppm) proposed by the petitioner.
Thus, the petitioner is required to submit a revised Section F to
reflect this determination.

Tropical Fruit

Guava

DER Reference:	47016707.der.doc (guava)

IR-4 submitted field trial data for bifenazate on guava.  Three field
trials were conducted on guava in Zone 3 (FL) in the U.S. during the
2004 growing season.

Each field trial consisted of one untreated plot and one treated plot.
Two foliar directed applications of a 50% WP formulation of bifenazate
were made to guava at ~0.5 lb ai/A/application, with 21- to 27-day RTIs,
for a total rate of ~1.0 lb ai/A (2x the maximum proposed seasonal rate
of 0.5 lb ai/A).  All applications were made using ground equipment in
~142 gal/A.  An adjuvant was added to the spray mixture for all
applications.  Mature guava samples were harvested 1 day after the
second application.

The guava samples were analyzed for combined residues of bifenazate and
its metabolite D3598 using an HPLC/ECD method.  The validated LOQ was
0.01 ppm for each analyte.  The LOD was 0.005 ppm for each analyte.
This method is adequate for data collection based on acceptable method
validation and concurrent method recoveries from guava fortified at
0.01-1.0 ppm.

A summary of residue data from the guava field trials is presented in
Table 11.    SEQ CHAPTER \h \r 1   SEQ CHAPTER \h \r 1 The maximum
combined residue of bifenazate and D3598 was 0.299 ppm in/on guava
harvested 1 day after the second application.

Table 11.   Summary of Residue Data from Guava Field Trials with
Bifenazate.

Crop matrix	Total Applic. Rate

(lb ai/A)	PHI (days)	Combined Bifenazate/D3598 Residue Levels (ppm)1

	n	Min.	Max.	HAFT2	Mean	Std. Dev.

Proposed Use Pattern:  Single foliar spray of the 50% WP formulation at
0.38-0.50 lb ai/A, 1-day PHI

Guava	1.04	1	6	0.039	0.299	0.279	0.188	0.092

1  Residues were quantitated/reported as bifenazate equivalents.

2  HAFT = Highest-Average field trial result.

Conclusions.  The submitted residue data for guava are adequate even
though the trials were conducted at an exaggerated rate (2x).  While the
submitted data for guava represent an overestimate of the residues
expected from the proposed single application, the degree of
exaggeration is less than that of the bean and peas field trials.  In
the guava trials, the application just prior to harvest was at the
proposed rate (1x) and for the beans and peas trials the application
just prior to harvest was 1.5x the proposed rate.  Additionally, guava
(and feijoa, jaboticaba, wax jambu, starfruit, passionfruit, and
acerola) do not contribute significantly to the dietary risk, the
submitted data will be used to support the proposed tolerance and
additional field trial data will not be required for guava.  Although
the locations of the field trials conducted for guava are not in strict
accordance with OPPTS Guideline 860.1500, the total number of field
trials is in accordance with the guideline

The field trial data for guava 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.  The tolerance spreadsheet recommends
an individual tolerance of 0.90 ppm for residues in/on guava which is
identical to that proposed by the petitioner.

According to the Reviewer’s Guide and Summary of HED ChemSAC Approvals
for Amending Crop Group/Subgroups [40 CFR 180.41] and Commodity
Definitions [40 CFR 180.1(h)], dated 6/14/06, the available data for
guava may be translated to support the proposed uses on feijoa,
jaboticaba, wax jambu, starfruit, passionfruit, and acerola.

Lychee

DER Reference:	47016702.der.doc (lychee)

IR-4 submitted field trial data for bifenazate on lychee.  Three field
trials were conducted on lychee fruit in the U.S. during the 2004
growing season in Zone 3 (FL).

Each field trial consisted of one untreated plot and one treated plot.
Two foliar directed applications of a 50% WP formulation of bifenazate
were made to lychee fruit at ~0.5 lb ai/A/application, with 20- to
21-day RTIs, for a total rate of ~1.0 lb ai/A (2x the maximum proposed
seasonal rate of 0.5 lb ai/A).  All applications were made using ground
equipment in 126-129 gal/A.  An adjuvant was added to the spray mixture
for all applications.  Mature lychee fruit samples were harvested 1 day
after the last application.

The lychee samples were analyzed for combined residues of bifenazate and
its metabolite D3598 using an HPLC/ECD method.  The validated LOQ in
this study was 0.01 ppm for each analyte.  The LOD is 0.005 ppm for both
analytes in/on samples of lychee.  This method is adequate for data
collection based on acceptable method validation and concurrent method
recoveries from lychee fortified at 0.01-3.0 ppm.

Samples were stored frozen (-28.9 to -19.9(C) prior to analysis.  The
maximum storage duration from harvest to analysis was 308 days (10.1
months) for lychee.  The available storage stability data (refer to DER
for MRID 4606702) indicate that residues of bifenazate are reasonably
stable under frozen storage conditions for 2 months (64 days) but
generally decline beginning at 2 months and level out at ~30% decline
after 8-10 months of storage.

A summary of residue data from the lychee field trials is presented in
Table 12.    SEQ CHAPTER \h \r 1 The maximum uncorrected combined
residues of bifenazate and D3598 were 2.594 ppm in/on lychee fruit
harvested 1 day following the last application.  After correcting for
approximately 30% decline during storage, maximum corrected combined
residues of bifenazate and D3598 were 3.706 ppm. No residue decline data
were included with the submitted field trial data, however, none are
required since the required number of lychee field trials is <3 trials.

Table 12.    Summary of Residue Data from Lychee Field Trials with
Bifenazate.

Commodity	Total Applic. Rate

 (lb ai/A)	PHI (days)	Combined Bifenazate/D3598 Residue Levels (ppm)1

	N	Min.	Max.	HAFT2	Mean	Std. Dev.

Proposed Use Pattern:  Single foliar spray of the 50% WP formulation at
0.38-0.50 lb ai/A, 1-day PHI

Bifenazate (uncorrected for decline)

Lychee 	1.01-1.02	1	6	1.545	2.594	2.574	2.155	0.403

Bifenazate (corrected for decline)

Lychee 	1.01-1.02	1	6	2.207	3.706	3.677	3.078	0.575

1  Residues were quantitated/reported as bifenazate equivalents.

2  HAFT = Highest-Average Field Trial.

Conclusions.  The submitted residue data for lychee are adequate even
though the trials were conducted at an exaggerated rate (2x).  While the
submitted data for lychee represent an overestimate of the residues
expected from the proposed single application, the degree of
exaggeration is less than that of the bean and peas field trials.  In
the lychee trials, the application just prior to harvest was at the
proposed rate (1x) and for the beans and peas trials the application
just prior to harvest was 1.5x the proposed rate.  Additionally, lychee
(longan, Spanish lime, rambutan, and pulasan) do not contribute
significantly to the dietary risk, the submitted data will be used to
support the proposed tolerance and additional field trial data will not
be required for lychee.  Although the locations of the field trials
conducted for guava are not in strict accordance with OPPTS Guideline
860.1500, the total number of field trials is in accordance with the
guideline.

The field trial data (corrected for decline) for lychee 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.  The tolerance
spreadsheet recommends an individual tolerance of 5.0 ppm for residues
in/on lychee.  This tolerance level recommendation is higher than the
level (4.0 ppm) proposed by the petitioner.  Thus, the petitioner is
required to submit a revised Section F to reflect this determination.

According to the Reviewer’s Guide and Summary of HED ChemSAC Approvals
for Amending Crop Group/Subgroups [40 CFR 180.41] and Commodity
Definitions [40 CFR 180.1(h)], dated s/14/06, the available data for
lychee may be translated to support the proposed uses on longan, Spanish
lime, rambutan, and pulasan.

Papaya

DER Reference:	47016708.der.doc (papaya)

IR-4 submitted field trial data for bifenazate on papaya.  Three field
trials were conducted on papaya in Zone 13 (FL and HI; 3 trials) in the
U.S. during the 2004 growing season.

Each field trial consisted of one untreated plot and one treated plot.
Two foliar directed applications of a 50% WP formulation of bifenazate
were made to papaya at ~0.5 lb ai/A/application, with 21- to 22-day
RTIs, for a total rate of ~1.0 lb ai/A (2x the maximum proposed seasonal
rate of 0.5 lb ai/A).  All applications were made using ground equipment
in 50-150 gal/A.  An adjuvant was added to the spray mixture for all
applications.  Mature to half ripe papaya samples were harvested 1 day
after the second application.

The papaya samples were analyzed for combined residues of bifenazate and
its metabolite D3598 using a HPLC/ECD method.  The validated LOQ was
0.01 ppm for each analyte.  The LOD was 0.005 ppm for both analytes
in/on samples of papaya.  This method is adequate for data collection
based on acceptable method validation and concurrent method recoveries
from papaya fortified at 0.01-2.0 ppm.

A summary of residue data from the papaya field trials is presented in
Table 13.    SEQ CHAPTER \h \r 1 The maximum combined residue of
bifenazate and D3598 was 1.887 ppm in/on papaya harvested 1 day after
the second application.

Table 13.   Summary of Residue Data from Papaya Field Trials with
Bifenazate.

Crop matrix	Total Applic. Rate

(lb ai/A)	PHI (days)	Combined Bifenazate/D3598 Residue Levels (ppm)1

	n	Min.	Max.	HAFT2	Mean	Std. Dev.

Proposed Use Pattern:  Single foliar spray of the 50% WP formulation at
0.38-0.50 lb ai/A, 1-day PHI

Papaya	1.02-1.04	1	6	0.108	1.887	1.253	0.720	0.647

1  Residues were quantitated/reported as bifenazate equivalents.

2  HAFT = Highest-Average field trial result.

Conclusions.  The submitted residue data for papaya are adequate even
though the trials were conducted at an exaggerated rate (2x).  While the
submitted data for papaya represent an overestimate of the residues
expected from the proposed single application, the degree of
exaggeration is less than that of the bean and peas field trials.  In
the papaya trials, the application just prior to harvest was at the
proposed rate (1x) and for the beans and peas trials, the application
just prior to harvest was 1.5x the proposed rate.  Additionally, papaya
(and black sapote, canistel, mamey sapote, mango, sapodilla, and star
apple) do not contribute significantly to the dietary risk, the
submitted data will be used to support the proposed tolerance and
additional field trial data will not be required for papaya.  The number
and locations of field trials are in accordance with OPPTS Guideline
860.1500 for papaya.

The field trial data for papaya 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.  The tolerance spreadsheet recommends
an individual tolerance of 7.0 ppm for residues in/on papaya.  This
tolerance level recommendation is higher than the level (6.0 ppm)
proposed by the petitioner.  Thus, the petitioner is required to submit
a revised Section F to reflect this determination.

According to the Reviewer’s Guide and Summary of HED ChemSAC Approvals
for Amending Crop Group/Subgroups [40 CFR 180.41] and Commodity
Definitions [40 CFR 180.1(h)], dated 6/14/06, the available data for
papaya may be translated to support the proposed uses on black sapote,
canistel, mamey sapote, mango, sapodilla, and star apple.

860.1520 Processed Food and Feed

HED does not require residue data for any processed commodities
associated with papaya, star apple, black sapote, mango, sapodilla,
canistel, mamey sapote, lychee, longan, Spanish lime, rambutan, pulasan,
guava, feijoa, jaboticaba, wax jambu, starfruit, passionfruit, acerola,
caneberry, wild raspberry, edible-podded legume vegetables,
succulent-shelled beans and peas, and succulent soybeans.

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

Analytical standards for bifenazate, with an expiration date of
4/1/2009,and its metabolite D3598, with an expiration date of 5/1/2008,
are currently available in the EPA National Pesticide Standards
Repository (personal communication with Dallas Wright, ACB, 5/15/07).
Analytical reference standards of bifenazate and its metabolite D3598
must be supplied, and supplies replenished as requested by the
Repository.  The reference standards should be sent to the Analytical
Chemistry Lab, which is located at Fort Meade, to the attention of
either Theresa Cole or William Chism at the following address:

	USEPA

	National Pesticide Standards Repository/Analytical Chemistry Branch/OPP

	701 Mapes Road

	Fort George G. Meade, MD  20755-5350

(Note that the mail will be returned if the extended zip code is not
used.)

860.1850 Confined Accumulation in Rotational Crops

Residue Chemistry Memo; DP# 324430, 7/19/06, T. Bloem

Residue Chemistry Memo DP# 277089, 8/16/01, T. Bloem

A confined accumulation study in rotational crops was previously
submitted and reviewed (Memo, 8/16/2001, T. Bloem, DP# 277089).
[14C]Bifenazate was applied to bare soil in pots at a rate equivalent to
0.5 lb ai/A or 5.0 lb ai/A.  The soil was aged for 30, 125, and 365 days
and was planted with carrot, lettuce, and wheat (soil aged for 365 days
was only planted with wheat).

The MARC reviewed the confined rotational crop study and concluded that
the residues of concern in/on rotational crops could not be determined
from the available data (Memo, 8/16/2001, T. Bloem, DP# 276801).  It was
concluded that a 30-day rotational crop restriction is appropriate for
the following reasons:  (1) application was made to bare soil; (2) TRRs
in mature carrot planted 30 days after treatment at 0.50 lb ai/A were
<0.01 ppm (0.007 ppm); (3) TRRs in mature lettuce planted 30 days after
treatment at 0.50 lb ai/A were 0.014 ppm; however, upon analysis, no
residues >0.01 ppm were identified; and (4) TRRs in wheat forage, wheat
hay, wheat chaff, and wheat grain planted 30 days after treatment at
0.50 lb ai/A were 0.038 ppm, 0.117 ppm, 0.031 ppm, and 0.016 ppm,
respectively; however, upon analysis, no residues >0.01 ppm were
identified.

860.1900 Field Accumulation in Rotational Crops

  SEQ CHAPTER \h \r 1 No field rotational crop data have been submitted.
 The following rotational crop restriction is specified for the 50% WP
(Acramite®-50WS) formulation:  “Do not plant another crop within 30
days after last Acramite®-50WS application due to chances of bifenazate
residues showing up in rotational crops”.  The product label for the 4
lb/gal FlC formulation (Acramite®-4SC) does not specify any rotational
crop restrictions and should be revised to specify a 30-day plantback
interval.

860.1550 Proposed Tolerances

In the subject petition, the proposed tolerance expression is in terms
of the combined residues of bifenazate (1-methylethyl
2-(4-methoxy[1,1’-biphenyl]3-yl)hydrazinecarboxylate) and
diazinecarboxylic acid, 2-(4-methoxy-[1,1’-biphenyl]-3-yl,
1-methylethyl ester (expressed as bifenazate).  The proposed tolerance
expression is consistent with the bifenazate tolerances established in
40 CFR §180.572(a)(1) and reflect the residues of concern as determined
by HED MARC.

Pending submission of revised Sections B and F, the available crop field
trial data support the proposed tolerances on edible-podded legume
vegetable, subgroup 6A and succulent-shelled pea and bean, subgroup 6B
in conjunction with a conditional registration while additional data are
submitted.  Pending submission of a revised Section F, the submitted
crop field trial data for caneberry, guava, lychee, papaya, are to set
tolerances.

HED has recently concluded that succulent-shelled soybean will be added
to the pea and bean, succulent-shelled, subgroup 6B.  Until the
regulations have been finalized in the Federal Register, a separate
tolerance is needed for this commodity, at the same level as the pea and
bean, succulent-shelled, subgroup 6B tolerance, 0.70 ppm; the proposed
tolerance for soybean, succulent-shelled must be increased. A revised
Section F to reflect these changes are required.

HED has recently concluded that wild raspberry will be added to the
caneberry subgroup 13A.  Until the regulations have been finalized in
the Federal Register, a separate tolerance is needed for residues in/on
this commodity, at the same level as the caneberry tolerance, 5.0 ppm;
the proposed tolerance for wild raspberry must be decreased.  A revised
Section F to reflect this change is required.

HED is in the process of revising the Commodity Definitions listed under
40 CFR §180.1(h) to include the tropical and subtropical fruit papaya,
guava, and lychee as general commodities.  The specific commodities
included in the definition are as follows:  (i) Papaya; black sapote;
canistel; mamey sapote; mango; sapodilla; and star apple; (ii) Guava;
feijoa; jaboticaba; wax jambu; starfruit; passionfruit; and acerola; and
(iii) Lychee; longan; Spanish lime; rambutan; and pulasan.  Until the
regulations have been finalized in the Federal Register, separate
tolerances are needed for each specific commodity, at the same level as
the respective general commodity tolerance.  The proposed tolerance for
guava is adequate, but increased tolerances are needed for residues
in/on papaya at 7.0 ppm and lychee at 5.0 ppm.  Therefore, proposed
tolerances for:  guava; feijoa; jaboticaba; wax jambu; starfruit;
passionfruit; and acerola will stay at the same level; and proposed
tolerances for:  papaya; black sapote; canistel; mamey sapote; mango;
sapodilla; and star apple and lychee; longan; Spanish lime; rambutan;
and pulasan will increase.

There are currently no established Codex, Canadian, or Mexican maximum
residue limits (MRLs) for bifenazate in/on the proposed commodities.
Therefore, harmonization is not an issue.

A summary of tolerance assessments, following HED review of submitted
field studies, is presented in Table 14.  The Agency’s Guidance for
Setting Pesticide Tolerances Based on Field Trial Data was utilized for
determining appropriate tolerance levels for edible-podded legume
vegetables (subgroup 6A), succulent-shelled pea and bean (subgroup 6B),
caneberry (subgroup 13A), guava, lychee, and papaya; see Appendix I for
tolerance calculations.  The combined residue levels of bifenazate/D3598
(in bifenazate equivalents) in/on these commodities were readily
quantifiable; no values were below the LOQ.  The available field trial
data indicate that the proposed tolerance for residues in/on guava is
adequate, but that increased tolerances are needed in/on papaya at 7.0
ppm; lychee at 5.0 ppm; edible-podded legume vegetables (subgroup 6A) at
6.0 ppm; and succulent-shelled pea and bean (subgroup 6B) at 0.7 ppm.
The proposed tolerance for caneberry subgroup 13A is too high; the
available data indicate that a tolerance of 5.0 ppm is appropriate.

Table 14.   Tolerance Summary for Bifenazate

Commodity	Proposed Tolerance (ppm)	Recommended Tolerance (ppm)	Comments;
Correct Commodity Definition

Papaya	6.0	7.0

	Star apple	6.0	7.0	Data translated from papaya.

Black sapote	6.0	7.0

	Mango	6.0	7.0

	Sapodilla	6.0	7.0

	Canistel	6.0	7.0

	Mamey sapote	6.0	7.0

	Lychee	4.0	5.0

	Longan	4.0	5.0	Data translated from lychee

Spanish lime	4.0	5.0

	Rambutan	4.0	5.0

	Pulasan	4.0	5.0

	Guava	0.9	0.90

	Feijoa	0.9	0.90	Data translated from guava

Jaboticaba	0.9	0.90

	Wax jambu	0.9	0.90

	Starfruit	0.9	0.90

	Passionfruit	0.9	0.90

	Acerola	0.9	0.90

	Caneberry subgroup 13A	6.0	5.0

	Wild raspberry	6.0	5.0	Data translated from Caneberry subgroup 13A

Vegetable, legume, edible-podded, subgroup 6A	4.0 1	6.0	Concomitantly,
the established tolerance for pea, edible-podded, succulent should be
removed.

Pea and bean, succulent-shelled, subgroup 6B	0.3 1	0.70	Concomitantly,
the established tolerance for pea, garden, succulent should be removed.

Soybean, succulent-shelled	0.3 2	0.70	Data translated from
succulent-shelled pea and bean, subgroup 6B

1  IR-4 had previously submitted a petition for bifenazate on garden pea
(succulent-shelled pea) and edible-podded pea (PP#5E6992; MRID
46651703).

2  A separate tolerance for succulent-shelled soybean is requested based
on the recommendations made by B. Schneider in an HED memorandum, dated
11/4/04 that a succulent-shelled soybean tolerance be established at the
same level as succulent-shelled beans.

References

DP#:		324430

Subject:	Bifenazate (PC Code 000586).  Section 3 Registration for
Application of Bifenazate to Tuberous and Corm Vegetable (crop subgroup
1c) and Succulent Pea.  Summary of Residue Chemistry Data.

From:		T. Bloem

To:		D. Rosenblatt/S. Jackson

Dated:		7/19/06

MRID(s):	46651701, 46651703, and 46651702

DP#:		313261

Subject:	Bifenazate (PC Code 000586).  Section 3 Registration for
Application of Bifenazate to Apple, Apricot, Cotton, Grape, Hops,
Nectarines, Peach, Pear, Plum (Prune), and Strawberry.  Petitioners
Response to Deficiencies Identified in HED’s Residue Chemistry Reviews
(D277089, T. Bloem, 16-Aug-2001 and D288660, T. Bloem, 20-Mar-2003).

From:		T. Bloem

To:		D. Kenny/S. Oonithan

Dated:		7/19/06

MRID(s):	46061401, 46064102, 46069801-46069804, 46176601, 46180601,
46691301

DP#:		297604

Subject:	Bifenazate (PC Code 000586).  Section 3 Registration for
Application of Bifenazate to Fruiting Vegetable (Crop Group 8), Cucurbit
Vegetables (Crop Group 9), Tree Nuts (Crop Group 14), Okra, and Mint.
Review of Amendment Submitted in Response to Residue Chemistry
Deficiencies Identified D286170 (T. Bloem, 20-April-2004)

From:		T. Bloem

To:		D. Rosenblatt/B. Madden

Dated:		7/12/06

MRID(s):	45941701, 46024201, 46024202, 46024203, and 46555001

DP#:		328814

Subject:	Letter to FDA for inclusion of confirmatory enforcement method
in PAM Volume II

From:		T. Bloem

To:

Dated:		5/17/06

MRID(s):	None

DP#:		None

Subject:	Reviewer’s Guide and Summary of HED ChemSAC Approvals for
Amending Crop Group/Subgroup [40 CFR 180.41] and Commodity Definitions
[40 CFR 180.1(h)]

From:		B. Schneider

To:		B. Madden

Dated:		6/14/06

MRID(s):	None

DP#:		290053

Subject:	Bifenazate (PC Code 000586).  Section 3 Registration for
Application of Bifenazate to Fruiting Vegetable (Crop Group 8), Cucurbit
Vegetables (Crop Group 9), Tree Nuts (Crop Group 14), Okra, and Mint.
Summary of Residue Chemistry Data.  ID#:  3E06517

From:		T. Bloem

To:		M. Laws/S. Oonnithan

Dated:		5/29/03

MRID(s):	45772001-45772010, and 45802801

DP#:		281979

Subject:	Letter to Mark Wirtz, Chemist, at Food and Drug Administration
enclosing the Petition Method Validation Reports

From:		T. Bloem

Dated:		8/29/02

MRID(s):	None

DP#:		281973

Subject:	ID# 0F06108 – Application of Bifenazate to Cotton, Grapes,
Hops, Pome Fruit, Stone Fruit, and Strawberry.  Results of Petition
Method Validation.  Chemical 000586.  Case 292702.  Submission S575895.

From:		T. Bloem

To:		A. Layne/R. Gebken

Dated:		8/29/02

MRID(s):	None

DP#:		276801

Subject:	MARC Decision

From:		T. Bloem

To:

Dated:		8/16/01

MRID(s):	None

DP#:		277089

Subject:	ID# 0F06108 - Bifenazate in/on Apple, Apricot, Cotton, Grape,
Hops, Nectarine, Peach, Pear, Plum (Prune), and Strawberry.  Evaluation
of Residue Data and Analytical Methods.  Chemical 000586.  Case 292702.
Submission S575895.

From:		T. Bloem

To:		T. Levine/S. Oonnithan

Dated:		8/16/01

MRID(s):	44237801, 45052224, 45052225, 45076505, 45052301-45052304,
45052311-			45052328

DP#:		276623

Subject:	ID# 0F06108 – Bifenazate in/on Apple, Apricot, Cotton,
Grapes, Hops, Nectarines, Peaches, Pear, Plums (Prunes), and
Strawberries.  Metabolism Assessment Review Committee (MARC) Briefing
Document.

From:		T. Bloem and W. Dykstra, HED and P. Jennings, EFED

To:		Y. Donovan

Dated:		7/31/01

MRID(s):	None

  SEQ CHAPTER \h \r 1 Attachments:

International Residue Limit Status sheet

Appendix I - Tolerance Assessment Calculations

Template Version September 2005

INTERNATIONAL RESIDUE LIMIT STATUS

Chemical Name:  hydrazine carboxylic acid,
2-(4-methoxy-[1,1’-biphenyl]-3-yl), 1-methylethyl ester	Common Name:

Bifenazate	X Proposed tolerance

( Reevaluated tolerance

( Other	Date: 5/14/07

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#6E7167

DP#:  337530

Other Identifier:

Residue definition (step 8/CXL):   sum of bifenazate and
bifenazate-diazene, expressed as bifenazate.	Reviewer/Branch:  William
Wassell, RAB1

	Residue definition:  Combined residues of bifenazate and D3598
(diazinecarboxylic acid, 2-(4-methoxy-[1,1’-biphenyl]-3-yl),
1-methylethyl ester) expressed as bifenazate  SEQ CHAPTER \h \r 1   SEQ
CHAPTER \h \r 1

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

Papaya	6.0

Star apple	6.0

Black sapote	6.0

Mango	6.0

Sapodilla	6.0

Canistel	6.0

Mamey sapote	6.0

Lychee	4.0

Longan	4.0

Spanish lime	4.0

Rambutan	4.0

Pulasan	4.0

Guava	0.90

Feijoa	0.90

Jaboticaba	0.90

Wax jambu	0.90

Starfruit	0.90

Passionfruit	0.90

Acerola	0.90

Caneberry subgroup 13A	6.0

Wild raspberry	6.0

Vegetable, legume, edible-podded subgroup 6A	4.0

Pea and bean, succulent-shelled, subgroup 6B	0.30

Soybean, succulent-shelled	0.30

Limits for Canada	Limits for Mexico

X   No Limits

   No Limits for the crops requested	X   No Limits

   No Limits for the crops requested

Residue definition  N/A.  Registered uses for greenhouse tomato,
cucumber, and pepper; and for apple and grapes, but no MRLs	Residue
definition:  N/A

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

	Notes/Special Instructions:  S. Funk, 05/16/2007.

Appendix I.  Tolerance Assessment Calculations.

Edible-Podded Legume Vegetables (Subgroup 6A)

Edible-Podded Bean and Pea

The dataset used to establish a tolerance for bifenazate on
edible-podded legume vegetables consisted of field trial data
representing application rates of 1.48-1.54 lb ai/A (2 applications at
0.739-0.772 lb ai/A/application) with a 2- to 4-day PHI.  Although the
field trial application rates and PHIs are not within 25% of the maximum
label application rate, as specified by the Guidance for Setting
Pesticide Tolerances Based on Field Trial Data SOP, the submitted data
were entered into the Agency’s tolerance spreadsheet.  The
representative commodities of the edible-podded legume vegetable
subgroup are any one succulent cultivar of edible-podded bean (Phaseolus
spp.) and any one succulent cultivar of edible-podded pea (Pisum spp.).

Data were previously submitted and reviewed for edible-podded pea (MRID
46651703); refer to PP#5E6992; DP# 324430, T. Bloem, 7/19/06.  As a
result, an individual tolerance has been established under 40 CFR
§180.572(a)(1) for the combined residues of bifenazate and D3598
(expressed as bifenazate) at 4.0 ppm in/on pea, edible-podded,
succulent.  Data for edible-podded bean were submitted in the subject
petition (MRID 47016705), and the residue values used to calculate the
tolerance are provided in Table II-1.

All 12 field trial sample results were above the LOQ. 1 Since there were
no values reported below the LOQ, maximum likelihood estimation (MLE)
procedures were not needed to impute censored values.

The bifenazate-bean (edible-podded) dataset was entered 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 bifenazate on edible-podded bean
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,
point estimate of the 99th percentile rounds to the value 6.0 ppm
(Figure II-2).  Because this value was the minimum value, 6.0 ppm is the
recommended tolerance level for bifenazate on edible-podded bean if an
individual tolerance is to be established.

In summary, the established individual tolerance is 4.0 ppm for pea,
edible-podded, succulent and the tolerance spreadsheet recommends an
individual tolerance of 6.0 ppm for edible-podded bean.  The bifenazate
residues do not vary by a factor of 5x between edible-podded bean and
edible-podded pea.  HED recommends a tolerance of 6.0 ppm for residues
of bifenazate in/on Subgroup 6A based on the residue data from
edible-podded bean.  This tolerance level recommendation is higher than
the level (4.0 ppm) proposed by the petitioner.

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

Regulator:	EPA

Chemical:	Bifenazate

Crop:	Bean, edible-podded

PHI:	2-4 Days

App. Rate:	2 at 0.739-0.772 lb ai/A/application

Submitter:	IR-4

MRID Citation:	MRID 47016705

	Combined Residues of Bifenazate/D3598 (ppm)

	1.786

	1.792

	1.446

	1.989

	0.152

	0.242

	0.541

	0.575

	0.643

	0.701

	0.996

	1.257

Figure II- 1.  Lognormal probability plot of bifenazate field trial data
for edible-podded bean.

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

Succulent-Shelled Pea and Bean (Subgroup 6B)

Succulent-Shelled Bean and Pea

The dataset used to establish a tolerance for bifenazate on
succulent-shelled bean and pea consisted of field trial data
representing application rates of 1.48-1.51 lb ai/A (2 applications at
0.735-0.783 lb ai/A/application) with a 2- to 4-day PHI.  Although the
field trial application rates and PHIs are not within 25% of the maximum
label application rate, as specified by the Guidance for Setting
Pesticide Tolerances Based on Field Trial Data SOP, the submitted data
were entered into the Agency’s tolerance spreadsheet.  Two
representative commodities of the succulent-shelled subgroup are:  (i)
any succulent-shelled cultivar of bean (Phaseolus spp.); or (ii)
immature soybean seed (Glycine max); or (iii) any Vigna spp. and garden
pea (Pisum spp.).

Data were previously submitted and reviewed for succulent-shelled pea
(MRID 46651703); refer to PP#5E6992; DP# 324430, T. Bloem, 7/19/06.  As
a result, an individual tolerance has been established under 40 CFR
§180.572(a)(1) for the combined residues of bifenazate and D3598
(expressed as bifenazate) at 0.20 ppm in/on pea, garden, succulent.
Data for succulent-shelled bean were submitted in the subject petition
(MRIDs 47016705 and 47016706), and the residue values used to calculate
the tolerance are provided in Table II-2.

All 13 field trial sample results were above the LOQ.  Since there were
no values reported below the LOQ, MLE procedures were not needed to
impute censored values.

The bifenazate-bean (succulent-shelled) 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 bifenazate on succulent-shelled bean
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%
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, point estimate of
the 99th percentile rounds to the value 0.70 ppm (Figure II-4).  Because
this value was the minimum value, 0.70 ppm is the recommended tolerance
level for bifenazate on succulent-shelled bean if an individual
tolerance is to be established.

In summary, the established individual tolerance is 0.2 ppm for pea,
garden, succulent and the tolerance spreadsheet recommends an individual
tolerance of 0.70 ppm for succulent-shelled bean.  The bifenazate
residues do not vary by a factor of 5x between succulent-shelled bean
and pea.  HED recommends a tolerance of 0.70 ppm for residues of
bifenazate in/on Subgroup 6B based on the residue data from
succulent-shelled bean.  This tolerance level recommendation is higher
than the level (0.3 ppm) proposed by the petitioner.

Table II-2.	Residue data used to calculate tolerance for bifenazate on
succulent-shelled bean.

Regulator:	EPA

Chemical:	Bifenazate

Crop:	Bean, succulent-shelled

PHI:	2-4 Days

App. Rate:	2 at 0.735-0.783 lb ai/A/application

Submitter:	IR-4

MRID Citation:	MRIDs 47016705 and 47016706

	Combined Residues of Bifenazate and D3598 (ppm)

	0.111

	0.178

	0.129

	0.017

	0.020

	0.058

	0.152

	0.136

	0.088

	0.046

	0.072

	0.182

	0.262

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

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

Caneberry (Subgroup 13A)

The dataset used to establish a tolerance for bifenazate on caneberries
consisted of field trial data representing application rates of
0.99-1.06 lb ai/A (2 applications at 0.49-0.56 lb ai/A/application) with
a 0-day PHI.  Although the field trial application rates and PHIs are
not within 25% of the maximum label application rate and minimum label
PHI, respectively, as specified by the Guidance for Setting Pesticide
Tolerances Based on Field Trial Data SOP, the submitted data were
entered into the Agency’s tolerance spreadsheet.  The residues values
used to calculate the tolerance are provided in Table II-3.

All 16 field trial sample results were above the LOQ.  Since there were
no values reported below the LOQ, MLE procedures were not needed to
impute censored values.

The bifenazate-caneberry dataset was entered into the tolerance
spreadsheet.  Visual inspection of the lognormal probability plot
(Figure II-5) provided in the spreadsheet indicates that the dataset is
reasonably lognormal.  The result from the approximate Shapiro-Francia
test statistic (Figure II-6) confirmed that the assumption of
lognormality should not be rejected.

Since the field trial data for bifenazate on caneberry represent a large
dataset (i.e., more than 15 samples) and are reasonably lognormal, the
minimum of the 95% 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 5.0 ppm (Figure II-6).  Because this
value was the minimum value, 5.0 ppm is the recommended tolerance level
for bifenazate on caneberry.

Table II-3.	Residue data used to calculate tolerance for bifenazate on
caneberry.

Regulator:	EPA

Chemical:	Bifenazate

Crop:	Caneberry

PHI:	0 Day

App. Rate:	2 at 0.49-0.56 lb ai/A/application

Submitter:	IR-4

MRID Citation:	MRID 47016704

	Combined Residues of Bifenazate and D3598 (ppm)

	1.615

	2.201

	3.151

	3.252

	1.423

	1.748

	1.379

	1.531

	1.374

	2.639

	1.248

	1.412

	2.263

	2.291

	2.480

	4.625

Figure II- 5.  Lognormal probability plot of bifenazate field trial data
for caneberry.

Figure II- 6.   Tolerance spreadsheet summary of bifenazate field trial
data for caneberry.

Guava

The dataset used to establish a tolerance for bifenazate on guava
consisted of field trial data representing application rates of 1.04 lb
ai/A (2 applications at 0.52 lb ai/A/application) with a 1-day PHI.
Although the field trial application rates are not within 25% of the
maximum label application rate, as specified by the Guidance for Setting
Pesticide Tolerances Based on Field Trial Data SOP, the submitted data
were entered into the Agency’s tolerance spreadsheet.  The residues
values used to calculate the tolerance are provided in Table II-4.

All 6 field trial sample results were above the LOQ.  Since there were
no values reported below the LOQ, MLE procedures were not needed to
impute censored values.

The bifenazate-guava dataset was entered into the tolerance spreadsheet.
 Visual inspection of the lognormal probability plot (Figure II-7)
provided in the spreadsheet indicates that the dataset is reasonably
lognormal.  The result from the approximate Shapiro-Francia test
statistic (Figure II-8) confirmed that the assumption of lognormality
should not be rejected.

Since the field trial data for bifenazate on guava 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% 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, point estimate of the 99th percentile rounds to the
value 0.90 ppm (Figure II-8).  Because this value was the minimum value,
0.90 ppm is the recommended tolerance level for bifenazate on guava.

Table II-4.	Residue data used to calculate tolerance for bifenazate on
guava.

Regulator:	EPA

Chemical:	Bifenazate

Crop:	Guava

PHI:	1 Day

App. Rate:	2 at 0.52 lb ai/A/application

Submitter:	IR-4

MRID Citation:	MRID 47016707

	Combined Residues of Bifenazate and D3598 (ppm)

	0.258

	0.299

	0.039

	0.184

	0.140

	0.210

Figure II- 7.  Lognormal probability plot of bifenazate field trial data
for guava.

Figure II- 8.   Tolerance spreadsheet summary of bifenazate field trial
data for guava.

Lychee

The dataset used to establish a tolerance for bifenazate on lychee
consisted of field trial data representing application rates of
1.01-1.02 lb ai/A (2 applications at 0.50-0.51 lb ai/A/application) with
a 1-day PHI.  Although the field trial application rates are not within
25% of the maximum label application rate, as specified by the Guidance
for Setting Pesticide Tolerances Based on Field Trial Data SOP, the
submitted data (corrected for decline) were entered into the Agency’s
tolerance spreadsheet.  The residues values used to calculate the
tolerance are provided in Table II-5.

All 6 field trial sample results were above the LOQ.  Since there were
no values reported below the LOQ, MLE procedures were not needed to
impute censored values.

The bifenazate-lychee dataset was entered into the tolerance
spreadsheet.  Visual inspection of the lognormal probability plot
(Figure II-9) provided in the spreadsheet indicates that the dataset is
reasonably lognormal.  The result from the approximate Shapiro-Francia
test statistic (Figure II-10) confirmed that the assumption of
lognormality should not be rejected.

Since the field trial data for bifenazate on lychee 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% 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, point estimate of the 99th percentile rounds to the
value 5.0 ppm (Figure II-10).  Because this value was the minimum value,
5.0 ppm is the recommended tolerance level for bifenazate on lychee.

Table II-5.	Residue data used to calculate tolerance for bifenazate on
lychee.

Regulator:	EPA

Chemical:	Bifenazate

Crop:	Lychee

PHI:	1 Day

App. Rate:	2 at 0.50-0.51 lb ai/A/application

Submitter:	IR-4

MRID Citation:	MRID 47016701

	Combined Residues of Bifenazate and D3598 (ppm)

	2.780

	2.854

	3.647

	3.706

	2.207

	3.273

Figure II- 9.  Lognormal probability plot of bifenazate field trial data
for lychee.

Figure II- 10.   Tolerance spreadsheet summary of bifenazate field trial
data for lychee.

Papaya

The dataset used to establish a tolerance for bifenazate on papaya
consisted of field trial data representing application rates of
1.02-1.04 lb ai/A (2 applications at 0.51-0.52 lb ai/A/application) with
a 1-day PHI.  Although the field trial application rates are not within
25% of the maximum label application rate, as specified by the Guidance
for Setting Pesticide Tolerances Based on Field Trial Data SOP, the
submitted data were entered into the Agency’s tolerance spreadsheet.
The residues values used to calculate the tolerance are provided in
Table II-6.

All 6 field trial sample results were above the LOQ.  Since there were
no values reported below the LOQ, MLE procedures were not needed to
impute censored values.

The bifenazate-papaya dataset was entered into the tolerance
spreadsheet.  Visual inspection of the lognormal probability plot
(Figure II-11) provided in the spreadsheet indicates that the dataset is
reasonably lognormal.  The result from the approximate Shapiro-Francia
test statistic (Figure II-12) confirmed that the assumption of
lognormality should not be rejected.

Since the field trial data for bifenazate on papaya represent a small
dataset (i.e., less than 15 samples) and are reasonably lognormal, the
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=Table II-6.	Residue data used to calculate tolerance for bifenazate on
papaya.

Regulator:	EPA

Chemical:	Bifenazate

Crop:	Papaya

PHI:	1 Day

App. Rate:	2 at 0.51-0.52 lb ai/A/application

Submitter:	IR-4

MRID Citation:	MRID 47016708

	Combined Residues of Bifenazate and D3598 (ppm)

	0.108

	0.137

	0.619

	1.887

	0.763

	0.805

Figure II- 11.  Lognormal probability plot of bifenazate field trial
data for papaya.

Figure II- 12.   Tolerance spreadsheet summary of bifenazate field trial
data for papaya.

Bifenazate (000586)	Summary of Analytical Chemistry and Residue Data	DP
No.:  337530

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