Document ID: EPA-HQ-OPP-2007-0535-0005
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2008-06-11T04:00Z

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, D.C.  20460

OFFICE OF           

PREVENTION, PESTICIDES

AND TOXIC SUBSTANCES

MEMORANDUM

Date:	04/01/2008

Subject:		PP#7E7227; Bifenthrin (128825). Section 3 Registration Request
for Application of Bifenthrin to Bushberry (Crop Subgroup 13B),
Juneberry, Lingonberry, Salal, Aronia Berry, Lowbush Blueberry, Buffalo
Currant, Chilean Guava, European Barberry, Highbush Cranberry,
Honeysuckle, Jostaberry, Native Current, Sea Buckthorn, and Leaf
Petioles (Crop Subgroup 4B) and FMC Corporation’s Field Trial Data on
Head Lettuce.  Summary of Analytical Chemistry and Residue Data. 

Petition No.	7E7227	Decision No:	379758

DP No.:	342661	40 CFR:	§180.442

Chemical No.:	128825	Class:	Synthetic Pyrethroid

Trade Name:	Capture 2EC, Capture LFR, Brigade 2EC, Brigade WSB	EPA Reg.
No.: 	279-3069; 279-3313; 279-3108, 279-3302

MRIDs:	47144501, 47144502, and 47144503

From:		William D. Wassell, Chemist

		Registration Action Branch 1 (RAB1)

		Health Effects Division (HED, 7509P)

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

		RAB1/HED (7509P)

To:		Daniel Rosenblatt/Shaja Brothers (RM 05)

	Registration Division (7505P) 

This document was originally prepared under contract by Dynamac
Corporation (2275 Research Blvd, Suite 300; Rockville, MD 20850;
submitted 01/09/2008).  The document has been reviewed by the HED and
revised to reflect current Office of Pesticide Programs (OPP) policies.

Executive Summary

Bifenthrin is a broad-spectrum, non-systemic insecticide/miticide in the
class of synthetic pyrethroids.  It is registered to FMC Corporation for
use as foliar applications on a variety of field, fruit, and vegetable
crops.

The Interregional Research Project No. 4 (IR-4), on behalf of the
Agricultural Experiment Stations of FL, MI, NJ, OR, TN, and TX, has
submitted requests for Section 3 registrations for the application of
bifenthrin to leafy petiole vegetables, subgroup 4B, [celery, cardoon,
Chinese celery, celtuce, Florence fennel, rhubarb, and Swiss chard] and
bushberries, subgroup 13B [blueberry (highbush and lowbush), currant,
elderberry, gooseberry, and huckleberry].  In conjunction with this
request, the petitioner has proposed the establishment of tolerances for
bifenthrin
[(2-methyl[1,1’-biphenyl]3-yl)methyl-3-(2-chloro-3,3,3-trifluoro-1-pro
penyl)-2,2-dimethyl-cyclopropanecarboxylate)] in/on:

Bushberry subgroup 13B	2.0 ppm

Juneberry	2.0 ppm

Lingonberry	2.0 ppm

Salal	2.0 ppm

Aronia berry	2.0 ppm

Blueberry, lowbush	2.0 ppm

Buffalo currant	2.0 ppm

Chilean guava	2.0 ppm

European barberry	2.0 ppm

Highbush cranberry	2.0 ppm

Honeysuckle	2.0 ppm

Jostaberry	2.0 ppm

Native currant	2.0 ppm

Sea buckthorn	2.0 ppm

Leaf petioles subgroup 4B	3.0 ppm

Concurrently,   SEQ CHAPTER \h \r 1 IR-4 requests the amendment of the
following end-use products (EPs) containing bifenthrin as the active
ingredient (ai) in order to include new uses on leafy petiole vegetables
and bushberries:  Capture® 2 EC (emulsifiable-concentrate formulation)
Insecticide/Miticide (EPA Reg. No. 279-3069), Brigade® 2EC (EPA Reg.
No. 279-3313), Brigade® WSB (water-soluble bag, EPA Reg. No. 279-3108),
and Capture® LFR Insecticide (EPA Reg. No. 279-3302).  These EPs are
proposed for multiple broadcast foliar applications at maximum seasonal
rates of 0.5 pound (lb) ai/acre (A) using ground or aerial equipment. 
The proposed pre-harvest intervals (PHIs) are 1 day for bushberries and
7 days for leafy petiole vegetables.

This summary document also addresses the adequacy of magnitude of the
residue data for head lettuce, which was submitted by FMC Corporation in
support of a request to register the use of bifenthrin on head lettuce
grown in CA.  It is noted that adequate field trial data supporting the
use of bifenthrin on head lettuce in the U.S. except CA were previously
reviewed (PP#1F6313, D278385, M. Nelson, 8/15/03).  Based on these data,
the Agency established a 3.0 ppm tolerance for bifenthrin on head
lettuce.

Tolerances for residues of bifenthrin are currently expressed in terms
of bifenthrin per se.  Permanent tolerances are established for
bifenthrin residues in/on several food commodities under 40 CFR
§180.442(a)(1).  The established tolerances for plant and livestock
commodities, under §180.422(a)(1), range from 0.05 ppm (various plant
and poultry commodities) to 25 ppm (coriander, dried leaves).  A
tolerance of 0.05 ppm is also established for residues of bifenthrin in
food/feed handling establishments under §180.422(a)(2).  In addition,
time-limited tolerances for residues of bifenthrin have been established
under §180.422(b) in connection with Section 18 emergency exemptions;
these include tolerances for orchardgrass, forage and hay each at 0.05
ppm with a 12/31/09 expiration date.

The nature of bifenthrin residues in plants and livestock is understood
based on the previously-submitted apple, corn, cotton, potato, hen, and
goat metabolism studies.  The residue of concern is bifenthrin per se in
primary crop commodities and in livestock.

The nature of the residues in rotational crops is adequately understood.
 Based on the confined rotational crop study, HED has concluded that the
residue of concern in rotational crops is the parent compound only. 
Based on a maximum seasonal use rate of 0.5 lb ai/A for annual crops,
the confined study and the available field rotational crop study on
wheat support the current rotational crop restrictions on the labels. 
Crops having bifenthrin tolerances may be replanted at any time, and all
other crops may be replanted 30 days following the last application of
bifenthrin.  No rotational crop tolerances are required.

Adequate gas chromatography (GC)/electron-capture detection (ECD)
methods are available for enforcing tolerances of bifenthrin in plant
and livestock commodities.  The available methods for plant commodities
generally involve extraction of the sample with acetone, partitioning
with hexane, purification using a Florisil column, and analysis of
residues by GC/ECD.  The limit of quantitation (LOQ) for these methods
is 0.05 ppm.

Samples from the current field trials were analyzed for residues of
bifenthrin using FMC methods PC-2132M (blueberry and celery) and P-3694
(head lettuce) that are modifications to one of the current enforcement
methods (P-2550 M), with variations in extraction solvents and detection
methods.  For each of the above methods, the validated LOQ for
bifenthrin is 0.05 ppm, and the reported limit of detection (LOD) is
0.01 ppm.  The methods were adequately validated in conjunction with
analysis of samples from the field trials.

The Food and Drug Administration’s PESTDATA database dated 10/99
(Pesticide Analytical Manual (PAM) Vol. I, Appendix II) indicates that
bifenthrin is completely recovered using MRM Section 303 (Mills, Onley,
and Gaither Method; Protocol E, non-fatty food) and that recoveries
using Section 302 (Luke Method; Protocol D) are variable.  No
information pertaining to the recovery of bifenthrin using Section 304
(Mills Method; Protocol E, fatty food) is available.  Additional MRM
data for bifenthrin are not required.  The MRM methods are adequate for
enforcement of bifenthrin tolerances.

Analytical standards for bifenthrin are currently available in the EPA
National Pesticide Standards Repository.  

The submitted supplemental residue data for head lettuce grown in CA
(Zone 10) are adequate.  They indicate that the established tolerance of
3.0 ppm for bifenthrin residues in/on head lettuce will not be exceeded
when the 2 lb/gal EC formulation is applied according to the registered
use pattern.  There are now adequate residue data for head lettuce grown
in CA (Zone 10); therefore, the label restriction prohibiting the use of
bifenthrin on head lettuce in CA may be removed.

The submitted residue data for celery are adequate, and the trials
conducted reflect the proposed use pattern for leaf petioles subgroup
4B.  The number and locations of celery trials are in accordance with
the requirements specified in the previous petition review (PP#6E4630;
DP# 277993, 8/15/02, S. Levy).  

The submitted residue data for blueberry are adequate, and the trials
conducted reflect the proposed use pattern for bushberry subgroup
13-07B.  The number and locations of crop field trials are in accordance
with OPPTS Guideline 860.1500.

There are adequate storage stability data to validate the storage
conditions and durations of raw agricultural commodities (RAC) samples
collected from the field trials.

There are no livestock feedstuffs associated with the proposed uses on
bushberries and leafy petiole vegetables.  Therefore, data requirements
pertaining to meat, milk, poultry, and eggs are not relevant to this
tolerance petition.

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

Pending submission of a revised Section B (see requirements under
860.1200 Directions for Use), a revised Section F (see requirements
under 860.1550 Proposed Tolerances), there are no residue chemistry
issues that would preclude granting a conditional registration for use
of this insecticide on the subgroups requested or the establishment of
tolerances for bifenthrin per se as follows:

Bushberry subgroup 13-07B	1.8 ppm

Leaf petioles subgroup 4B	3.0 ppm

860.1200  Directions for Use

•	There are now adequate residue data supporting bifenthrin use on
head lettuce grown in CA.  Therefore, the petitioner may submit a
revised Section B to remove the existing restriction prohibiting use of
bifenthrin on head lettuce grown in CA.

•	Label revisions are required to remove the statement that emulsified
oil may be substituted for water for aerial applications; the submitted
crop field trials do not reflect the use of emulsified oil.

860.1550  Proposed Tolerances

•	The petitioner is required to submit a revised Section F to amend
the proposed tolerance for Bushberry subgroup 13-07B and to reflect
correct commodity definition as reflected in Table 9.

A human-health risk assessment is forthcoming.

Background

The chemical structure and nomenclature of bifenthrin are presented in
Table 1.  The physiochemical properties of the technical grade of
bifenthrin are presented in Table. 2.



Table 1.		Bifenthrin Nomenclature.

Chemical structure	

Common name	Bifenthrin

Company experimental name	FMC 54800

IUPAC name	2-methylbiphenyl-3-ylmethyl
(1RS,3RS)-3-[(Z)-2-chloro-3,3,3-trifluoroprop-1-enyl]-2,2-dimethylcyclop
ropanecarboxylate

or

(2-methyl[1,1′-biphenyl]-3-yl)methyl
(1R,3R)-rel-3-[(1Z)-2-chloro-3,3,3-trifluoro-1-propenyl]-2,2-dimethylcyc
lopropanecarboxylate

CAS registry number	82657-04-03

End-use product (EP)	2.0 lb ai/gal emulsifiable-concentrate formulation
(Capture® 2EC; EPA Reg. No. 279-3069 and Brigade® 2EC; EPA Reg. No.
279-3313)

10% wettable-powder formulation  (Brigade® WSB, EPA Reg. No. 279-3108)

1.5 lb/gal flowable-concentrate (Capture® LFR; EPA Reg. No. 279-3302)

<0.1 μg/L

	Solvent solubility	8.9 in heptane and methanol

125 in acetone, chloroform, ether, methylene chloride, and toluene 

	Vapor pressure	2.41 x 10-5

	Dissociation constant, pKa	Not applicable

	Octanol/water partition coefficient, Log(KOW)	>1 x 10 6

	UV/visible absorption spectrum	NA

	1 NA = information not available. 

860.1200  Directions for Use

The petitioner has submitted draft labels for the 2 lb/gal EC
formulations (Capture® 2EC Insecticide/Miticide; EPA Reg. No. 279-3069
and Brigade® 2EC Insectide/Miticide; EPA Reg. No. 279-3313), the 10% WP
formulation (Brigade® WSB Insectide/Miticide; EPA Reg. No. 279-3108),
and the 1.5 lb/gal FlC formulation (Capture® LFR; EPA Reg. No.
279-3302).  Information pertaining to the proposed EPs is listed in
Table 3.  A summary of the proposed use patterns is included 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

Capture®

2 EC Insecticide/

Miticide	279-3069	25.1% (equivalent to 2 lb ai/gal)
Emulsifiable-concentrate (EC)	Bushberries:  blueberry, highbush and
lowbush, currant; elderberry; gooseberry; huckleberry

Leafy petiole vegetables:  celery; cardoon; Chinese celery; celtuce;
Florence fennel; rhubarb; Swiss chard

Head lettuce	Insects controlled: aphid species, army cutworm, armyworm
species, blueberry maggot, corn earworm, crickets, cucumber beetles,
cutworm species, diamondback moth, flea beetles, fruitworms, ground
beetles, grubs, imported cabbageworm, Japanese beetle, leaf hoppers,
leaf rollers (obliquebanded, red banded, and variegated), lecanium scale
(crawlers), lettuce root aphids, loopers, Lygus Spp., plum curculio,
root maggot, salt marsh caterpillar, spanworm, stink bugs spp.,
tarnished plant bugs, thrips, tobacco budworm, whitefly, wireworm
(adults), whiteflies

Mites controlled: bank grass mite, bulb mites, carmine mite, Pacific
spider mite, two-spotted spider mite	5-11-07 draft label 

Brigade® WSB Insecticide/

Miticide	279-3108	10%	Wettable-powder

(WP)

	5-17-07 draft label

Brigade® 2EC Insecticide/

Miticide	279-3313	25.1% (equivalent to 2 lb ai/gal)	EC

	5-11-07 draft label

Capture® LFR Insecticide	279-3302	17.15% (equivalent to 1.5 lb ai/gal)
Flowable-concentrate (FlC)

	5-17-07 draft label

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

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

Foliar, Broadcast, Ground (≥10 gal/A) or aerial (≥2 gal/A)	2 lb/gal
EC

[279-3069]	0.10	Not specified

(NS)	0.5	1

	10% WP

[279-3108]	0.10	NS	0.5	1

	2 lb/gal EC

[279-3313]	0.10	NS	0.5	1

	1.5 lb/gal FlC

≥10 gal/A) or aerial (≥2 gal/A)	2 lb/gal EC

[279-3069]	0.10	NS	0.5	7

	10% WP

[279-3108]	0.10	NS	0.5	7

	2 lb/gal EC

[279-3313]	0.10	NS	0.5	7

	1.5 lb/gal FlC

[279-3302]	0.10	NS	0.5	7

	Use Directions and Limitations:  For aerial applications, 1-2 quarts of
emulsified oil may be substituted for 1-2 quarts of water in the
finished spray.  A minimum 7-day RTI is specified.  

Lettuce, head

Foliar, Broadcast, Ground (≥15 gal/A for 2 lb/gal EC and ≥20 gal/A
for 10% WP) or aerial (≥5 gal/A)	2 lb/gal EC

[279-3069]	0.10	NS	0.5	7

	10% WP

[279-3108]	0.10	NS	0.5	7

	2 lb/gal EC

[279-3313]	0.10	NS	0.5	7

	Use Directions and Limitations:  For aerial applications of the EC
formulation, 1-2 quarts of emulsified oil may be substituted for 1-2
quarts of water in the finished spray.  A minimum 7-day RTI.

At planting

Soil banded, in-furrow, or broadcast soil surface

Ground	1.5 lb/gal FlC

[279-3302]	0.08	NS	(at plant)

0.5 (at plant + foliar applications of other bifenthrin products)	NS

	Use Directions and Limitations:  Applications may be made as a 5-7 inch
band over an open furrow (T-band), in-furrow with the seed, or broadcast
over the entire acre on the soil surface.

The following rotational crop restriction is specified for the 2 lb/gal
EC, 10% WP, and 1.5 lb/gal FlC formulations:  Crops for which bifenthrin
tolerances exist may be rotated at any time.  All other crops may be
rotated 30 days following the final application of bifenthrin.  The
labels specify a restricted-entry interval (REI) of 12 hours for all
formulations.

The labels state that the products may be tank mixed with other products
approved for use on registered crops.  All restrictions and precautions
must be observed which appear on the labels of these products.  No
specific tank mix partners are specified.

The draft labels for the 2 lb/gal EC formulations prohibit use in CA. 
In addition, these labels specify that the product may be applied
through sprinkler including center pivot, lateral move, end tow, side
(wheel) roll, traveler, big gun, solid set, or hand move irrigation
systems.  The draft labels for the 10% WP and 1.5 lb/gal FlC
formulations specify that application through any type of irrigation
system is prohibited.

HED notes that the draft label for 1.5 lb/gal FlC formulation states
under Directions for Use that product is for ground application only,
and application by air is prohibited, but indicates under the specific
use directions for leafy petiole vegetables and bushberries that the
product may be applied by air.

Conclusions.  The proposed use directions are adequate to allow
evaluation of the residue data relative to the proposed use.  However,
since adequate field trial data are now available to support the use of
the 2 lb/gal EC formulation on head lettuce grown in CA (Zone 10); label
revisions are required to remove the restriction prohibiting use in CA
from the product label.  Label revisions are required for the proposed
EPs to remove the statement that emulsified oil may be substituted for
water for aerial applications; the submitted crop field trials do not
reflect the use of emulsified oil.

860.1300 Nature of the Residue – Plants and Livestock

Bifenthrin TRED; DP# 283808, 8/21/02, S. Levy

Adequate studies are available depicting the metabolism of
[14C]bifenthrin in apples, corn, and cotton.  The nature of the residue
in plants is adequately understood based on previously submitted plant
metabolism studies on corn, cotton, apple and potato.  HED has
determined that for purposes of the tolerance expression and risk
assessment, the residue of concern in cotton and apple commodities is
bifenthrin per se.  The HED Metabolism Committee in 1993 re-examined the
cotton and apple metabolism data and examined additional corn metabolism
data; the Committee determined that the residues of concern in plant
commodities for tolerance setting and risk assessment are bifenthrin per
se (Memo, M. Flood, 7/23/93).

The qualitative nature of the residue in livestock is adequately
understood based on goat and hen metabolism studies.  The HED Metabolism
Committee determined that for purposes of tolerance expression and risk
assessment, the residue of concern in livestock is bifenthrin per se
(Memo of M. Flood, 7/23/93).

860.1340 Residue Analytical Methods

Bifenthrin TRED; DP# 283808, 8/21/02, S. Levy

Adequate GC/ECD methods are available for enforcing tolerances of
bifenthrin in plant and livestock commodities.  The available methods
for plant commodities generally involve extraction of the sample with
acetone, partitioning with hexane, purification using a Florisil column,
and analysis of residues by GC/ECD.  The limit of quantitation (LOQ) for
these methods is 0.05 ppm.

Samples from the current field trials were analyzed for residues of
bifenthrin using FMC methods PC-2132M (blueberry and celery) and P-3694
(head lettuce) that are modifications to one of the current enforcement
methods (P-2550 M), with variations in extraction solvents and detection
methods.  Residues of bifenthrin in/on blueberry and celery were
determined using a GC/ECD method (FMC Report P-2132M).  For this method,
residues are extracted with hexane using the Dionex ASE-200,
concentrated, and cleaned up using a Florisil column, then analyzed by
GC/ECD.  Residues in/on head lettuce were determined using a
GC/mass-selective detection (MSD) method (FMC Report P-3694).  For this
method, a NaCl solution is added to the sample and residues are
extracted with acetone, partitioned with hexane, concentrated, and
purified on an aminopropyl solid-phase extraction (SPE) cartridge.  The
residues are eluted with hexane and analyzed by GC/MSD using the m/z 181
and m/z 165 ions for quantitation.  For each of the above methods, the
validated LOQ for bifenthrin is 0.05 ppm, and the reported LOD is 0.01
ppm.  Each of these methods was adequately validated in conjunction with
analysis of samples from the field trials.

860.1360 Multiresidue Methods

Bifenthrin TRED; DP# 283808, 8/21/02, S. Levy

The Food and Drug Administration’s PESTDATA database dated 10/99
(Pesticide Analytical Manual (PAM) Vol. I, Appendix II) indicates that
bifenthrin is completely recovered using MRM Section 303 (Mills, Onley,
and Gaither Method; Protocol E, non-fatty food) and that recoveries
using Section 302 (Luke Method; Protocol D) are variable.  No
information pertaining to the recovery of bifenthrin using Section 304
(Mills Method; Protocol E, fatty food) is available.  Additional MRM
data for bifenthrin are not required.  The MRM methods are adequate for
enforcement of bifenthrin tolerances.  

860.1380 Storage Stability

Bifenthrin TRED; DP# 283808, 8/21/02, S. Levy

HED Memo (DP# 277993, 8/15/02, S. Levy)

The maximum storage duration from harvest to analysis was 82 days (2.7
months) for blueberry, 232 days (7.6 months) for celery, and 339 days
(11.2 months) for head lettuce.  The storage durations and conditions of
samples from the crop field trials submitted to support this petition
are presented in Table 5.

Table 5.   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

Blueberry	-27 to -15	37–82 days

(1.2–2.7 months)	188 days

(6.2 months)

Celery	- 27 to -16	83-232 days

(2.7-7.6 months)	562 days

(18.5 months)

Head Lettuce	~ -18	44-339 days

(1.4-11.2 months)	36 months

No storage stability data were submitted with the subject petition. 
Storage stability data for residues of bifenthrin in/on a variety of
commodities are available.  In the Bifenthrin TRED  SEQ CHAPTER \h \r 1 
 SEQ CHAPTER \h \r 1 , HED has concluded that residues of bifenthrin are
stable during frozen storage for up to:  12 months in corn flour, meal,
oil, and starch; 18 months in/on oranges (whole) and orange dried pulp,
juice, and oil; 24 months in/on cottonseed; 34 months in/on corn grain;
36 months in/on lettuce, pecans, and potatoes; and 49 months in/on
apple, corn silage, and corn stover.  Storage stability studies
conducted concurrently with crop field trial studies indicate that
residues of bifenthrin are stable during frozen storage for up to:  147
days in/on artichoke; 196 days in/on lima beans (shelled); 142 days
in/on snap beans; 294 days in/on head and stem Brassica vegetables; 136
days in/on canola; 369 days in/on cantaloupe; 361 days in/on cucumbers;
136 days in/on eggplant; 176 days in/on grapes; 127 days in/on green and
dried hops; 300 days in/on head lettuce; 192 days in/on shelled peas;
166 days in/on bell peppers; 200 days in/on non-bell peppers; 188 days
in/on raspberries; 359 days in/on squash.  In addition, the available
storage stability data (DP# 277993, 8/15/02, S. Levy) indicate that
residues of bifenthrin are stable under frozen storage conditions for a
maximum of 562 days (18.5 months) in/on celery.  

Conclusions.  The storage conditions and durations of samples from the
blueberry, celery, and head lettuce field trials are supported by
adequate storage stability data.  Additional storage stability data are
not required.

860.1480 Meat, Milk, Poultry, and Eggs

There are no livestock feedstuffs associated with the proposed uses on
bushberries and leafy petiole vegetables.  Therefore, data requirements
pertaining to meat, milk, poultry, and eggs are not relevant to this
tolerance petition.

860.1500 Crop Field Trials

Lettuce, head

Residue Chemistry Memo, DP# 257714, 1/31/00, Y. Donovan (PP#9E6030,
9E6031, 9E6016, 9E6034)

Residue Chemistry Memo, D278385, 8/15/03, M. Nelson, PP#1F6313

DER Reference List:  47144503.der.doc

Adequate field trial data are available supporting the use of bifenthrin
on head lettuce in the U.S. (PP#1F6313, D278385, M. Nelson, 8/15/03). 
Based on these data, the Agency established a 3.0 ppm tolerance for
bifenthrin on head lettuce.  Although a Federal tolerance has been
established, FMC Corporation indicated that additional head lettuce
field trials conducted in CA were needed to obtain a state registration.
 Subsequently, additional residue data in support of a registration for
use of the 2 lb/gal EC formulation on head lettuce grown in CA/Zone 10
were submitted, pertinent parts of the Executive Summary of the study
DER are reproduced below.

FMC Corporation has submitted supplemental field trial data (MRID
47144503) for the use of bifenthrin on head lettuce.  Four field trials
were conducted in the U.S. in Zone 10 (AZ and CA) during the 2003 and
2004 growing seasons.  Each plot consisted of one untreated and one
treated plot.  At each trial site, five broadcast foliar applications of
2 lb/gal EC formulation of bifenthrin were made at 6- to 8-day
retreatment intervals (RTIs) to head lettuce at 0.10 lb
ai/A/application, for a total seasonal rate of 0.50 lb ai/A. 
Applications were made using spray equipment in ~20–21 gal/A spray
volumes without an adjuvant.

Lettuce samples were harvested at commercial maturity, 6- to 8-days
after the last application of bifenthrin.  Additional samples were
harvested from one trial at 1, 3, and 14 days after the last application
of 2 lb/gal EC formulation to evaluate decline.  Samples of head lettuce
were analyzed for residues of bifenthrin using GC/MSD method contained
in FMC Report P-3694 (MRID 46960404).  The method is adequate based on
acceptable concurrent recovery data.  

The results of the lettuce field trials are summarized in Table 6. 
Following five broadcast foliar applications of 2 lb/gal EC formulation,
at 0.1 lb ai/A/application, for a total seasonal rate of 0.5 lb ai/A,
residues of bifenthrin were <0.05-0.77 ppm and <0.05-0.41 ppm, for
lettuce with wrapper leaves and lettuce without wrapper leaves,
respectively.  Residue decline data indicate that bifenthrin residues
in/on lettuce heads decline with increasing PHIs.

Table 6.   Summary of Residue Data from Lettuce Trials with Bifenthrin.

Commodity	Total Applic. Rate

(lb ai/A)	PHI (days)	Residue Levels1 (ppm)

	n	Min.	Max.	HAFT2	Mean	Std. Dev.

Proposed Use Pattern:   Maximum Seasonal Rate of 0.5 lb ai/A with a
7-day PHI.

Lettuce w/ wrapper leaves	0.50	6-8	8	<0.05	0.77	0.76	0.29	0.30

Lettuce w/o wrapper leaves

	8	<0.05	0.41	0.40	0.20	0.14

1  For calculation of the HAFT, median, mean, and standard deviation,
the LOQ (<0.05 ppm) was used for any value reported as <LOQ or between
the LOD and LOQ in Table C.3.

2  HAFT = Highest-Average Field Trial result.

Conclusions:  The submitted supplemental residue data for head lettuce
grown in CA/Zone 10 are adequate.  They indicate that the established
tolerance 3.0 ppm for bifenthrin residues in/on head lettuce will not be
exceeded when the 2 lb/gal EC formulation is applied according to the
registered use pattern.  There are now adequate residue data for head
lettuce grown in CA/Zone 10; therefore, the label restriction
prohibiting the use of bifenthrin on head lettuce in CA may be removed.

Leafy petioles subgroup 4B

Celery

Residue Chemistry Memo, DP# 221185, 3/26/96, W. Wassell (PP#6E04630)

Residue Chemistry Memo, DP# 277993, 8/15/02, S. Levy (PP#6E04630)

DER Reference List	47144502.der.doc

IR-4 has submitted field trial data for the use of bifenthrin on celery
in response to a data gap specified in DP# 277993 (8/15/02, S. Levy). 
Four side-by-side field trials were conducted in the U. S. in Zones 3
(FL; 1 trial), 5 (OH; 1 trial), and 10 (CA; 2 trials) during the 2004
growing season.  Each trial site consisted of one untreated plot and two
treated plots.  At each treated plot, five foliar directed/broadcast
applications of either the 2 lb/gal EC or 10%WP formulation of
bifenthrin were made at 6- to 8-day RTIs to celery at 0.096-0.106 lb
ai/A/application, for a total seasonal rate of 0.497-0.515 lb ai/A. 
Applications were made using spray equipment in 35–53 gal/A spray
volumes without an adjuvant.

Celery samples were harvested at commercial maturity, 6- to 8-days after
the last application of bifenthrin.  It is noted that the above-cited
HED memo requested that all field trials should reflect a 7- and 14-day
PHIs.  Samples of celery were analyzed for residues of bifenthrin using
a modification of the GC/ECD enforcement method (FMC Corporation Method
P-2132M).  The method is adequate based on acceptable concurrent and
method validation recovery data.  

The results of the celery field trials are summarized in Table 7. 
Following five foliar direct applications of 2 lb/gal EC or 10% WP
formulation, at ~0.1 lb ai/A/application, for a total seasonal rate of
0.5 lb ai/A, residues of bifenthrin were 0.11-1.78 ppm and 0.06-1.16
ppm, respectively.

Table 7.   Summary of Residue Data from Celery Trials with Bifenthrin.

Commodity	EP	Total Applic.

Rate 

(lb ai/A)	PHI

(days)	Residue Levels (ppm)

n	Min.	Max.	HAFT1	Mean	Std. Dev.

Proposed Use Pattern:   Maximum Seasonal Rate of 0.5 lb ai/A with a
7-day PHI.

Celery	2 lb/gal EC	0.497-0.514	6-7	8	0.11	1.78	1.49	0.75	0.54

Celery	10% WP	0.499-0.515	6-7	8	0.06	1.16	1.07	0.56	0.38

1  HAFT = Highest-Average Field Trial result.

Conclusions:  The submitted residue data for celery are adequate, and
the trials conducted reflect the proposed use pattern for leaf petioles
subgroup 4B.  The number and locations of celery trials are in
accordance with the requirements specified in the previous petition
review (PP#6E04630; DP# 277993, 8/15/02, S. Levy).  

The aggregate of residue data for celery 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
appropriate tolerance levels; see Appendix I.  The tolerance spreadsheet
recommends an individual tolerance of 3.0 ppm for residues in/on celery.
 Thus, HED recommends a tolerance of 3.0 ppm for residues of bifenthrin
per se in/on leaf petiole subgroup 4B based on the residue data from
celery.  This tolerance level recommendation is identical to the level
proposed by the petitioner.

Bushberry subgroup 13

Blueberry

DER Reference List	47144501.der.doc

IR-4 has submitted field trial data for the use of bifenthrin on
blueberries.  Nine field trials were conducted in the U.S. in Zones 1
(ME; 1 trial), 2 (NC and NJ; 3 trials), 5 (MI; 3 trials), 10 (CA; 1
trial), and 12 (OR; 1 trial) during the 2004 growing season.  Trials
consisted of one untreated plot and either one (5 sites) or two (4
sites) treated plots.  At each trial site, five foliar
directed/broadcast applications of the 2 lb/gal EC formulation were made
at 4- to 8-day RTIs to blueberries at 0.093-0.106 lb ai/A/application,
for a total seasonal rate of 0.498-0.507 lb ai/A.  At four trials, a
second treated plot received five foliar direct/broadcast applications
of 10% WP at 0.096-0.102 lb ai/A/application, with 6- to 8-day RTIs, for
a total seasonal rate of 0.492-0.499 lb ai/A.  All applications were
made using spray equipment in 21-51 gal/A spray volumes without an
adjuvant.

At each trial, one control and two treated blueberry samples were
harvested at commercial maturity, 1 day after the last application of
bifenthrin.  Samples of blueberry were analyzed for residues of
bifenthrin using a modification of the GC/ECD enforcement method titled
“Analytical Method for the Determination of Bifenthrin in/on Various
Crops and Soils” (FMC Corporation Method P-2132M).  The method is
adequate based on acceptable concurrent and method validation recovery
data. 

The results of the blueberry trials are summarized in Table 8. 
Following five foliar direct applications of the 2 lb/gal EC or 10% WP
formulation, at ~0.1 lb ai/A/application, for a total seasonal rate of ~
0.5 lb ai/A, maximum residues of bifenthrin were 1.61 ppm and 1.06 ppm,
respectively.

Table 8.  Summary of Residue Data from Blueberry Field Trials with
Bifenthrin.

Commodity	Total Applic. Rate

 (lb ai/A)	PHI (days)	EP	Residue Levels  (ppm)

n	Min.	Max.	HAFT1	Mean	Std. Dev.

Proposed Use Pattern:  Maximum Seasonal Rate of 0.5 lb ai/A with a 1-day
PHI.

Blueberry	0.498-0.509	1	2 lb/gal EC	18	0.36	1.61	1.36	0.80	0.34

	0.492-0.499	1	10% WP	8	0.37	1.06	0.91	0.65	0.28

1  HAFT = Highest-Average Field Trial result.

Conclusions.  The submitted residue data for blueberry, which is the
representative commodity of bushberry subgroup 13-07B, are adequate. 
The number and locations of crop field trials are in accordance with
OPPTS Guideline 860.1500.  The trials reflect the proposed use pattern.

The residue data for blueberry 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 appropriate
tolerance levels; see Appendix I.  The tolerance spreadsheet recommends
an individual tolerance of 1.8 ppm for residues in/on blueberry.  Thus,
HED recommends a tolerance of 1.8 ppm for residues of bifenthrin per se
in/on bushberry subgroup 13-07B based on the residue data from
blueberry.  This tolerance level recommendation is lower than the level
proposed by the petitioner.

860.1520 Processed Food and Feed

HED does not require residue data for any processed commodities
associated with head lettuce, celery, or blueberry.  Therefore, data
requirements for processed food and feed are not relevant to this
tolerance petition.

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

Analytical standards for bifenthrin are currently available in the EPA
National Pesticide Standards Repository (personal communication with
Dallas Wright, ACB, 11/13/07).  Analytical reference standards of
bifenthrin 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 Frederic Siegelman 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 and 860.1900 Confined/Field Accumulation in Rotational Crops

Bifenthrin TRED; DP# 283808, 8/21/02, S. Levy

Adequate confined and field rotational crop studies are available. 
Based on the confined study, HED has concluded that the residue of
concern in rotational crops is the parent compound only.  Based on a
maximum seasonal use rate of 0.5 lb ai/A for annual crops, the confined
study and the available field rotational crop study on wheat also
support the current rotational crop restrictions on the labels.  Crops
having bifenthrin tolerances may be replanted at any time, and all other
crops may be replanted 30 days following the last application of
bifenthrin.  No rotational crop tolerances are required.

860.1550 Proposed Tolerances

Tolerances for residues of bifenthrin are currently expressed in terms
of bifenthrin per se.  Permanent tolerances are established for
bifenthrin residues in/on several food commodities under 40 CFR
§180.442(a)(1).  The established tolerances for plant and livestock
commodities, under §180.422(a)(1), range from 0.05 ppm (various plant
and poultry commodities) to 25 ppm (coriander, dried leaves).  A
tolerance of 0.05 ppm is also established for residues of bifenthrin in
food/feed handling establishments under §180.422(a)(2).  In addition,
time-limited tolerances for residues of bifenthrin have been established
under §180.422(b) in connection with Section 18 emergency exemptions;
these include tolerances for orchardgrass, forage and hay each at 0.05
ppm with a 12/31/09 expiration date.

The tolerances proposed by the petitioner in the current petition are
listed below in Table 9, along with HED’s recommended tolerance
levels.   SEQ CHAPTER \h \r 1  The petitioner must submit a revised
Section F reflecting the revised tolerances and commodity definitions
presented in Table 9.  The Agency’s Guidance for Setting Pesticide
Tolerances Based on Field Trial Data was utilized for determining
appropriate tolerance levels for bushberry (subgroup 13-07B) and leaf
petioles subgroup 4B; see Appendix I.  The Agency’s tolerance
spreadsheet was not used to determine a tolerance level for head lettuce
since the supplementary head lettuce residue data for CA   SEQ CHAPTER
\h \r 1 indicate that the established tolerance of 3 ppm will not be
exceeded.

The Agency has finalized the revision to the existing bushberry subgroup
13B (Federal Register Vol. 72, No. 235, pages 69150-69158; 12/7/07) to
include the following commodities:  aronia berry; blueberry, lowbush;
buffalo currant; Chilean guava; European barberry; cranberry, highbush;
honeysuckle, edible; jostaberry; Juneberry; lignonberry; native currant;
salal; and sea buckthorn.  Separate tolerances for these individual
commodities are no longer needed.  In addition, the final rule changes
the subgroup name from “bushberry subgroup 13B” to “bushberry
subgroup 13-07B.”

The submitted field trial data for blueberry, the representative
commodity of bushberry subgroup 13-07B are adequate.  The field trial
data for blueberry 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 appropriate
tolerance levels; see Appendix I.  The tolerance spreadsheet recommends
an individual tolerance of 1.8 ppm for blueberry which may be used to
support a tolerance for bifenthrin in/on the bushberry subgroup 13-07B. 
This tolerance level recommendation is lower than the level proposed by
the petitioner.

The submitted field trial data for celery, the representative commodity
of leaf petiole subgroup 4B are adequate.  The field trial data for
celery 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 appropriate tolerance levels; see
Appendix I.  The tolerance spreadsheet recommends an individual
tolerance of 3.0 ppm for celery which may be used to support a tolerance
for bifenthrin in/on the leaf petiole subgroup 4B.  This tolerance level
recommendation is identical to the level proposed by the petitioner.

There are currently no established Codex, Canadian, or Mexican maximum
residue limits (MRLs) for bifenthrin in/on the proposed commodities. 
Therefore, harmonization is not an issue.  An International Residue
Limit (IRL) form is appended to this Summary Document and follows this
section.



Table 9. 	Tolerance Summary for Bifenthrin

Crop Group or Commodity	Proposed Tolerance (ppm)	Recommended Tolerance
(ppm)	Comments; Correct Commodity Definition

Bushberry subgroup 13B	2.0	1.8	Bushberry subgroup 13-07B

Juneberry	2.0	Not needed	Separate tolerances for new commodities listed
in crop subgroup 13-07B are no longer required; refer to the Final Rule
published in the Federal Register 12/7/07.

Lingonberry	2.0

Salal	2.0

Aronia berry	2.0

Blueberry, lowbush	2.0

Buffalo currant	2.0

Chilean guava	2.0

European barberry	2.0

Highbush cranberry	2.0

Honeysuckle	2.0

Jostaberry	2.0

Native currant	2.0

Sea buckthorn	2.0

Leaf petioles subgroup 4B	3.0	3.0

	

References

DP#:	221185

Subject:	PP#6E04630  Bifenthrin (Brigade® WSB, EPA Reg. No. 279-3108)
in Celery.  Evaluation of Analytical Methodology and Residue Data. 
Chemical 128825.

From:	W. Wassell

To:	H. Jamerson  SEQ CHAPTER \h \r 1 

Date:	3/26/96

MRIDs:	43844101

DP#s:	257714, 257830, 257516, and 257926

Subject:	PP#9E6030, 9E6031, 9E6016, 9E6034  Bifenthrin – Proposal for
Tolerances of Residues in/on Bell and Non-bell Peppers, Lettuce (head),
Grapes, and Caneberries.  Residue Chemistry Reviews.

From:	Y. Donovan

To:	H. Jamerson  SEQ CHAPTER \h \r 1 

Date:	1/31/00

MRIDs:	44859801, 44859802, 44869601, 44869602, 448870500-448870503,
44875100, and 44875101 

DP#:	277993

Subject:	PP#6E04630  Bifenthrin in/on Leaf Petioles Subgroup 4B. 
Evaluation of Residue Data and Analytical Methods.  Chemical 128825. 
Case 287170.  Submission S603553.

From:	S. Levy

To:	G. LaRocca  SEQ CHAPTER \h \r 1 

Date:	8/15/02

MRIDs:	45286701

DP#:	283808

Subject:	Bifenthrin (PC Code:  128825).  Residue and Product Chemistry
Considerations for the Tolerance Reassessment Eligibility Decision
(TRED).  Case# 819530.  Submission# S617493.

From:	S. Levy

To:	T. Myers  SEQ CHAPTER \h \r 1 

Date:	8/21/02

MRIDs:	None

  SEQ CHAPTER \h \r 1 Attachments:  

International Residue Limit Status sheet

Appendix I - Tolerance Assessment Calculations

RDI: RAB1 Chemists:  03/05/2008

Petition Number:  7E7227

DP Number:  342661

PC Code:  128825

Template Version September 2005



INTERNATIONAL RESIDUE LIMIT STATUS

Chemical Name:   (2-methyl[1,1-biphenyl]3-yl)
methyl-3-(2-chloro-3,3,3-trifluoro-1-propenyl)-2,2-dimethyl-cyclopropane
carboxylate	Common Name:

Bifenthrin	√ Proposed tolerance

( Reevaluated tolerance

( Other	Date: 11/12/07

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#7E7227

DP#:  342661

Other Identifier:  

Residue definition (step 8/CXL):  Bifenthrin (fat-soluble)
Reviewer/Branch:  W. Wassell/RAB1

	Residue definition:  Bifenthrin per se  SEQ CHAPTER \h \r 1   SEQ
CHAPTER \h \r 1 

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

Bushberry subgroup 13B	2.0

Juneberry	2.0

Lignonberry	2.0

Salal	2.0

Aronia berry	2.0

Blueberry, lowbush	2.0

Buffalo, currant	2.0

Chilean guava	2.0

European barberry	2.0

Highbush cranberry	2.0

Honeysuckle	2.0

Jostaberry	2.0

Native currant	2.0

Sea buckthorn	2.0

Leaf petioles subgroup 4B	3.0

Limits for Canada	Limits for Mexico

√  No Limits

 No Limits for the crops requested	 No Limits

√  No Limits for the crops requested

Residue definition:  N/A	Residue definition:  Bifentrina

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

	Notes/Special Instructions:  S.Funk, 11/13/2007.

Appendix I.  Tolerance Assessment Calculations.

Bushberry (Subgroup 13-07B)

Blueberry

The dataset used to establish a tolerance for bifenthrin on bushberry
subgroup 13-07B consisted of field trial data for blueberry, the
representative of subgroup 13-07B.  The data reflect application rates
of 0.492-0.509 lb ai/A (5 applications at 0.093-0.106 lb
ai/A/application) of an EC or WP formulation with a 1-day PHI.  As
specified by the Guidance for Setting Pesticide Tolerances Based on
Field Trial Data SOP, the field trial application rates and PHIs are
within 25% of the maximum label application rate and minimum label PHI,
respectively.  The residue values used to calculate the tolerance are
provided in Table I-1.

All field trial sample results for blueberry were above the LOQ (LOQ =
0.05 ppm).

The bifenthrin-blueberry dataset was entered into the tolerance
spreadsheet.  Visual inspection of the lognormal probability plot
(Figure I-1) provided in the spreadsheet indicates that the dataset is
reasonably lognormal.  The result from the approximate Shapiro-Francia
test statistic (Figure I-2) confirmed that the assumption of
lognormality should not be rejected.

Since the field trial data for bifenthrin on blueberry represent a large
dataset (26 samples) and are reasonably lognormal, the minimum of the
95% upper confidence limit (UCL) on the 95th percentile and the point
estimate of the 99th percentile should be selected as the tolerance
value.  Using the rounding procedure as outlined in the Guidance for
Setting Pesticide Tolerances Based on Field Trial Data SOP, the 95% UCL
on the 95th percentile rounds to the value 1.8 ppm and the point
estimate of the 99th percentile rounds to the value 1.9 ppm (Figure
I-2).  Because the 1.8-ppm value was the minimum value, 1.8 ppm is the
recommended tolerance level for bifenthrin on blueberry.  A crop
subgroup tolerance is appropriate for bushberry subgroup 13-07B.  The
recommended value is 1.8 ppm, the maximum of the recommended individual
tolerance.

Table I-1.	Residue data used to calculate tolerance for bifenthrin on
bushberry subgroup 13-07B.

Regulator:	EPA

Chemical:	Bifenthrin

Crop:	Blueberry (EC and WP)

PHI:	1 Day

App. Rate:	0.492-0.509 lb ai/A

Submitter:	IR-4

MRID Citation:	MRID 47144501

	Residues of Bifenthrin (ppm)

	0.500

	0.360

	1.100

	1.610

	0.950

	0.880

	0.870

	1.430

	0.800

	0.960

	0.420

	0.540

	0.710

	0.600

	0.790

	0.890

	0.520

	0.480

	0.640

	1.030

	1.060

	0.760

	0.480

	0.390

	0.430

	0.370

Figure I-1.  Lognormal probability plot of bifenthrin field trial data
for blueberry.

Figure I-2.   Tolerance spreadsheet summary of bifenthrin field trial
data for blueberry.

Leaf petioles subgroup 4B

Celery



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application rates of 0.493-0.515 lb ai/A (5 applications at 0.096-0.106
lb ai/A/application) of an EC or WP formulation with a 6- to 8-day PHI. 
As specified by the Guidance for Setting Pesticide Tolerances Based on
Field Trial Data SOP, the field trial application rates and PHIs are
within 25% of the maximum label application rate and minimum label PHI,
respectively.  The residue values used to calculate the tolerance are
provided in Table I-2.

All field trial sample results for celery were above the LOQ (LOQ = 0.05
and 0.1 ppm).

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

Since the field trial data for bifenthrin on celery represent a large
dataset (40 samples) and are reasonably lognormal, the minimum of the
95% upper confidence limit (UCL) on the 95th percentile and the point
estimate of the 99th percentile should be selected as the tolerance
value.  Using the rounding procedure as outlined in the Guidance for
Setting Pesticide Tolerances Based on Field Trial Data SOP, the 95% UCL
on the 95th percentile and the point estimate of the 99th percentile
round to the value 3.0 ppm (Figure I-4).  Therefore, 3.0 ppm is the
recommended tolerance level for bifenthrin on celery.  A crop subgroup
tolerance is appropriate for leaf petiole subgroup 4B.  The recommended
value is 3.0 ppm, the maximum of the recommended individual tolerance.

Table I-2.	Residue data used to calculate tolerance for bifenthrin on
leaf petiole subgroup 4B.

Regulator:	EPA

Chemical:	Bifenthrin

Crop:	Celery (EC and WP)

PHI:	6-8 Days

App. Rate:	0.493-0.515 lb ai/A

Submitter:	IR-4

MRID Citation:	MRIDs 43844101, 45286701 & 47144502

	Residues of Bifenthrin (ppm)

	1.780

	1.200

	0.710

	0.650

	0.730

	0.690

	0.110

	0.150

	1.160

	0.970

	0.430

	0.470

	0.690

	0.580

	0.060

	0.130

	0.470

	0.430

	0.570

	0.190

	0.250

	0.300

	0.340

	0.280

	1.130

	1.000

	1.230

	1.260

	0.640

	0.650

	0.790

	0.760

	0.260

	0.310

	0.870

	0.910

	0.280

	0.610

	0.110

	0.220

Figure I-3.  Lognormal probability plot of bifenthrin field trial data
for celery.

Figure I-4.   Tolerance spreadsheet summary of bifenthrin field trial
data for celery.

Bifenthrin	Summary of Analytical Chemistry and Residue Data	DP#:  342661

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