Document ID: EPA-HQ-OPP-2007-0234-0006
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2007-10-24T04:00Z

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, D.C.  20460

OFFICE OF

PREVENTION, PESTICIDES

AND TOXIC SUBSTANCES

MEMORANDUM

Date:		22 August 2007

Subject:	Fluazinam.  Tolerance Petitions   SEQ CHAPTER \h \r 1
Requesting the Establishment of Permanent 		Tolerances (Associated with
Section 3 Registration) for Food Use of the Herbicide 	on Edible-Podded
Beans (Subgroup 6-A, Except Peas), Shelled 	Succulent Beans 	(Subgroup
6-B, Except Peas), Shelled Dried Beans (Subgroup 6-C, Except Peas), 
Brassica (Cole) Vegetables (Group 5), Bushberries (Subgroup 13-B), and
Ginseng.  	Summary of Analytical Chemistry and Residue Data.  

		Petition Numbers:		6E7137, 6E7139

		PC Code:			129098

		DP Number:			335640

		Decision Numbers:		372193, 372348

		Regulatory Citation:		40CFR §180.574

		Chemical Class:		Phenyl-pyridinamine Fungicide

		Trade Name:			Omega 500F

		MRID Numbers:		46986701 & -02, 46986705 to -07, 

						46990501 to -03, 46996601 & -02

From:		William T. Drew, Chemist

		Registration Action Branch 2

		Health Effects Division (7509P)

Through:	Douglas Dotson, PhD, Chemist

		Richard A. Loranger, PhD, Senior Scientist

		Registration Action Branch 2

		Health Effects Division (7509P)

To:		Daniel Rosenblatt/Shaja Brothers, RM Team 5

		Risk Integration, Minor Use, and Emergency Response Branch

		Registration Division (7505P)

Executive Summary

	Fluazinam (with CAS registry number 79622-59-6, and CAS name
3-chloro-N-[3-chloro-2,6-dinitro-4-(trifluoromethyl)phenyl]-5-(trifluoro
methyl)-2-pyridinamine) is a non-systemic phenyl-pyridinamine fungicide
currently registered for use on peanuts and potatoes.  There is also a
tolerance established for fluazinam in imported wine grapes (without US
registration).  Permanent tolerances are established for residues of
fluazinam in peanuts and potatoes at 0.02 ppm (40CFR §180.574[a][1]),
and in imported wine grapes at 3.0 ppm (40CFR §180.574[a][2]). 

	Interregional Research Project #4 (IR-4) has submitted petitions
(PPs#6E7137, 6E7139) proposing the use of a formulation containing 4.17
pounds per gallon (lb/gal) of fluazinam (Omega 500F Agricultural
Fungicide; EPA Registration #71512-1) on various crops.  This end-use
product (EP) is formulated as a flowable-suspension (F) concentrate. 
ISK Biosciences Corporation is the data submitter and registrant for the
active ingredient (ai), fluazinam, in the US.  

	In PP#6E7139, IR-4 has requested registration of fluazinam for use on
shelled succulent beans (Subgroup 6-B, except peas), shelled dried beans
(Subgroup 6-C, except peas), and ginseng.  In conjunction with these
uses, IR-4 and ISK Biosciences have proposed the establishment of
permanent tolerances for fluazinam in various crops, as listed below.  

Ginseng								3.00 ppm

Bean, dry								0.01 ppm

Succulent-shelled legume vegetables subgroup 6-B, except peas	0.02 ppm

	In PP#6E7137, IR-4 has requested registration of fluazinam for use on
edible-podded beans (Subgroup 6-A, except peas), Brassica vegetables
(Group 5), and bushberries (Subgroup 13-B).  In conjunction with these
uses, IR-4 and ISK Biosciences have proposed the establishment of
permanent tolerances for fluazinam in various crops, as listed below. 
Individual tolerances were also requested for fluazinam in turnip
leaves, a future member of the leafy Brassica greens subgroup 5-B, and
for fluazinam in the future members of the bushberries subgroup 13-B, as
approved by ChemSAC.  

Edible-podded legume vegetables subgroup 6-A, except peas	0.15 ppm

Leafy Brassica greens subgroup					0.02 ppm

Turnip, leaves						0.02 ppm

Head and stem Brassica subgroup					0.01 ppm

Bushberry subgroup 13-B						  4.5 ppm

Aronia berry						  4.5 ppm

Blueberry, lowbush					  4.5 ppm

Buffalo currant					  4.5 ppm

Chilean guava						  4.5 ppm

European barberry					  4.5 ppm

Highbush cranberry					  4.5 ppm

Honeysuckle						  4.5 ppm

Jostaberry						  4.5 ppm

Juneberry						  4.5 ppm

Lingonberry						  4.5 ppm

Native currant						  4.5 ppm

Salal							  4.5 ppm

Sea buckthorn						  4.5 ppm

	  SEQ CHAPTER \h \r 1 The nature of the residue in plants has been
adequately delineated, based on acceptable potato, peanut, and grape
metabolism studies reviewed previously (D257115; William Cutchin;
5/21/2001), along with an acceptable apple metabolism study submitted
recently (MRID #46991301).  At a meeting held on 11/28/2000, HED
concluded that the residue of concern (ROC) in potatoes and peanuts (for
both tolerance expression and dietary risk assessment purposes) was the
parent compound only (D272624; William Cutchin; 4/23/2001).  In wine
grapes, both parent and AMGT were included in the ROC for tolerance
expression and risk assessment.  Additionally, HED determined that data
generated for potential new uses on other crops (with the exception of
root and tuber, and bulb vegetables) should include analyses for both
parent and AMGT.  

	The nature of the residue in livestock is also understood, based on
adequate goat and hen metabolism studies (D257115; William Cutchin;
5/21/2001).  The fluazinam residues of regulatory interest in animals
were determined by HED to be parent plus the metabolites AMPA and DAPA,
and their sulfamate conjugates.  

	The submitted gas chromatography with electron-capture detection
(GC/ECD) methods (modifications of the tolerance-enforcement method) are
adequate for collecting data and enforcing tolerances for residues of
fluazinam per se in the various crop commodities associated with this
petition.  The lowest level of method validation (LLMV) and/or limit of
quantitation (LOQ) for residues of fluazinam per se were 0.010 ppm in
all plant matrices except snap beans and lima beans, in which the
LLMV/LOQ were 0.020 ppm.  The tolerance-enforcement method, Fluazinam: 
Method for the Analysis in Peanut Nut Meat (MRID #43521016), was
adequately radiovalidated, and underwent a successful independent
laboratory validation (ILV) trial.  The method was forwarded to BEAD’s
Analytical Chemistry Branch (ACB) for a petition method validation (PMV)
trial, and was subsequently determined to be suitable as a
tolerance-enforcement method (D266802; Paul Golden; 6/22/2001).  

	The submitted high performance liquid chromatography with ultraviolet
detection (HPLC/UV) method (a working method based on Method Evaluation
for the Analysis of AMGT in Grapes, MRID #45593101) is adequate for
collecting data and enforcing tolerances for AMGT residues in
blueberries.  The LLMV, limit of detection (LOD), and LOQ were 0.020,
0.013, and 0.038 ppm, respectively, for residues of AMGT in blueberries.
 HED has previously determined that residues of AMGT are to be regulated
in wine grapes (D272624; William Cutchin; 4/23/2001).  The Agency
therefore requested that this method undergo an ILV trial, and,
potentially, a PMV trial by the ACB.  An ILV study has not yet been
submitted.  

	The multiresidue method (MRM) testing data indicate that fluazinam is
partially recovered through Sections 302, 303, and 304 of PAM Volume I,
with its recovery being dependent on which Florisil elution system is
used.  The MRMs can serve as a confirmatory procedure for residues of
fluazinam.  Data should also be provided for the metabolite AMGT, since
it is included in the tolerance expression for grapes.  

	Adequate storage stability data were collected indicating that   SEQ
CHAPTER \h \r 1 fluazinam residues were stable under frozen storage in
blueberries, snap beans, and broccoli for the storage durations and
conditions of the samples from the respective crop field trials.  In
blueberries, AMGT residues were stable under frozen storage for the
storage durations and conditions of the samples from the blueberry field
trials.  However, storage stability studies indicated that there was
significant dissipation of fluazinam residues under frozen storage in
ginseng, lima beans, dried beans, cabbage, and mustard greens. 
Correction factors were therefore incorporated into the recommended
tolerances for fluazinam in ginseng, shelled succulent beans, and
shelled dried beans to account for dissipation during storage.  A
correction factor was not utilized when setting the recommended
tolerance in Brassica leafy vegetables, because fluazinam applications
made to cabbage and mustard greens were essentially identical to the
treatment of broccoli (which had acceptable storage stability), and all
residues in treated samples from the Brassica field trials were ≤LOQ
(≤0.010 ppm).  

	The available crop field trial data are adequate, and support the
proposed uses.  Following treatment with fluazinam (F) at total seasonal
rates ranging from 3.83 to 4.22 pounds ai per acre (lb ai/A), residues
of fluazinam in treated blueberry samples ranged from 0.064 to 2.0 ppm,
and residues of AMGT ranged from 0.025 to 0.13 ppm (with combined
residues of 0.166-2.094 ppm) at the target pre-harvest interval (PHI) of
30 days (23-32 days).  Following treatment with fluazinam (F) at total
seasonal rates ranging from 0.881 to 0.921 lb ai/A, residues of
fluazinam in treated snap bean samples ranged from <0.020 to 0.109 ppm
at the target PHI of 14 days (11-15 days).  Residues of fluazinam were
either less than or equal to the LLMV/LOQ (0.010 ppm) in all samples of
broccoli, cabbage, or mustard greens harvested at PHIs ranging from 22
to 113 days after a single root-drench application of fluazinam (F) at a
rate of 0.055 lb ai per 1000 plants.  Following treatment with fluazinam
(F) at total seasonal rates ranging from 3.13 to 3.39 lb ai/A, residues
of fluazinam in treated ginseng samples ranged from 0.28 to 1.4 ppm at
the target PHI of 30 days (29-31 days).  Following treatment with
fluazinam (F) at total seasonal rates ranging from 0.871 to 0.960 lb
ai/A, residues of fluazinam in treated dried bean samples ranged from
<0.010 to 0.011 ppm at the target PHI of 30 days (31-57 days). 
Following treatment with fluazinam (F) at total seasonal rates ranging
from 0.885 to 0.912  lb ai/A, residues of fluazinam in treated lima bean
samples were all less than the LLMV (0.020 ppm) at the target PHI of 30
days (28-71 days).  However, it was noted that residue data for AMGT
were provided only for blueberries; AMGT data should also have been
included with the field trial studies for edible-podded beans, shelled
succulent and dried beans, and Brassica vegetables.  

	There are no processed commodities for which residue data are required
associated with the proposed uses on the crops requested in the subject
petitions under review.  

	There are no significant livestock feed items associated with the
proposed uses on the crops requested in the subject petitions under
review.  

	Regulatory requirements pertaining to fluazinam residues in rotational
crops have been fulfilled, and the rotational crop restrictions on the
proposed label are adequate.  

  SEQ CHAPTER \h \r 1 There are no established or proposed Canadian or
Codex Maximum Residue Limits (MRLs) for residues of fluazinam in plant
or animal commodities.  There are Mexican MRLs established for residues
of fluazinam in potato at 0.05 ppm, and in beans at 0.1 ppm.  The
International Residue Limit Status sheet is shown in Appendix 1.  

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

	No major deficiencies were noted in the subject petition that would
preclude the establishment of permanent tolerances for fluazinam
residues in the requested crops.  Revised Sections F should be
submitted, so that the proposed tolerances reflect the recommended
tolerance levels, and correct commodity definitions, as specified in
Table 12.  Issues pertaining to residue chemistry deficiencies should be
resolved (see below).  

As a condition of registration, results of an ILV trial for the AMGT
analytical method (with wine grapes) should be submitted by the
registrant.  If the registrant agrees with the modifications made by
Ricerca to the original method (in MRID #45593101), these modifications
should be incorporated into a revised method for the ILV.  Sample sets
should include, at the minimum, 2 control (untreated) samples of wine
grapes, 2 samples fortified at the tolerance level (3.0 ppm), and 2
samples fortified at the LOQ (0.010 ppm).  

As a condition of registration, MRM recovery data should be provided for
the metabolite AMGT, since it is included in the tolerance expression
for wine grapes.  

The product label for Omega 500F should be amended to include a
restriction, stating that turnip roots from turnip plants treated with
this EP must not be used for human nor livestock consumption.  

The Agency has previously determined, and the registrant is hereby
advised again, that residue data for AMGT should be provided in the crop
field trial studies for all future requested plant commodities, except
root and tuber, and bulb vegetables.  

HED recommends in favor of establishing permanent tolerances for
fluazinam in the requested crops, at the levels specified in Table 12.  

Background

	  SEQ CHAPTER \h \r 1 Fluazinam (Omega 500F Agricultural Fungicide) is
a non-systemic, preventive, contact fungicide of the phenyl-pyridinamine
class, with a multi-site mode of action.  It disrupts the production of
energy at several metabolic sites within the fungal cell.  Fluazinam is
a protectant fungicide; when applied to plants, it remains primarily on
the plant surface, is not taken up to any extent by the plant, and is
not translocated within the plant.

	Fluazinam is currently registered for use on peanuts and potatoes. 
There is also a tolerance established for fluazinam in imported wine
grapes (without US registration).  Permanent tolerances have been
established for residues of fluazinam in peanuts and potatoes at 0.02
ppm, and in imported wine grapes at 3.0 ppm. 

	IR-4 has submitted petitions (PPs#6E7137, 6E7139) proposing the use of
a formulation containing 4.17 lb/gal of fluazinam (Omega 500F
Agricultural Fungicide; EPA Registration #71512-1) on various crops. 
This EP is formulated as a flowable suspension concentrate.  ISK
Biosciences Corporation is the data submitter and registrant for the ai,
fluazinam, in the US.  The nomenclature of fluazinam is summarized in
Table 1 (below), and the physicochemical properties of fluazinam are
summarized in Table 2 (below).  

  SEQ CHAPTER \h \r 1 TABLE 1.	Test Compound Nomenclature.

Compound	Chemical Structure

                              

Empirical Formula	

C13H4Cl2F6N4O4

Molecular Weight	465.1

Common Name	Fluazinam

Company Experimental Names	Fluazinam, IKF-1216

IUPAC Name
3-chloro-N-(3-chloro-5-trifluoromethyl-2-pyridyl)-α,α,α-trifluoro-2,6
-dinitro-p-toluidine

CAS Name
3-chloro-N-[3-chloro-2,6-dinitro-4-(trifluoromethyl)phenyl]-5-(trifluoro
methyl)-2-pyridinamine

CAS Number	79622-59-6

End-use Product/(EP)	Omega® 500F (USA); Allegro® 500F (Canada)

  SEQ CHAPTER \h \r 1 TABLE 2.	Physicochemical Properties of Fluazinam

Parameter	Value	Reference

Melting Point/Range	115-117°C	The e-Pesticide Manual (13th Edition)
Version 3.1

pH	5.85	MRID #43521001

Density (25°C)	1.02 g/cm3*	LSS 2000_1973_2LS_rev

Water Solubility (25°C)	(pH buffered to 5) 0.131 mg/L

(pH buffered to 7) 0.157 mg/L

(pH buffered to 9) 3.384 mg/L	LSS 2000_1973_2LS_rev

Solvent Solubility (25°C)	Solvent

	Solubility (mg/mL)	LSS 2000_1973_2LS_rev

	acetone

dichloromethane

ethyl acetate

ethyl ether

hexane

methanol

octanol

toluene	853

675

722

231

8

192

41

451

	Vapor Pressure 	Temp (°C)	Vap. Press. (Pa)	LSS 2000_1973_2LS_rev

	25

35

45	2.3 x 10-5

1.3 x 10-4

λmax (nm)	Regulatory Note REG2003-12

	5

7

>10	238

239, 342

260, 343, 482

	  SEQ CHAPTER \h \r 1 *REG2003-12 states the relative density as 1.76
g/cm3, temperature not stated.  

860.1200	Directions for Use

	IR-4 and ISK Biosciences are proposing the use of a flowable-suspension
concentrate formulation containing 4.17 lb/gal of fluazinam (Omega 500F
Agricultural Fungicide; EPA Registration #71512-1) on various crops. 
Copies of the proposed labels were provided, and the proposed uses on
the requested crops are summarized in Table 3 (below).  

	In PP#6E7139, IR-4 has requested registration of fluazinam for use on
shelled succulent beans (Subgroup 6-B, except peas), shelled dried beans
(Subgroup 6-C, except peas), and ginseng.  The proposed use pattern for
Omega 500F to control white mold (Sclerotinia sclerotiorum) and gray
mold (Botrytis cinerea) in shelled succulent and dried beans is up to
two foliar applications (with the first made when 10-30% of plants have
at least one open bloom) at rates of 0.26-0.45 lb ai/A per application
(in water volume adequate to provide coverage of foliage and flowers). 
If need be, a second application may be made at a 7- to 10-day
re-treatment interval (RTI), for a maximum total seasonal application
rate of 0.90 lb ai/A, with a minimum PHI of 30 days.  The proposed use
pattern to control Rhizoctonia root rot (Rhizoctonia solani) in ginseng
is up to 6 broadcast applications (with the first made at transplant) at
a rate of 0.52 lb ai/A, with subsequent applications repeated at 14-day
RTIs.  The proposed use pattern to control alternaria blight (Alternaria
panax), botrytis blight (Botrytis cinerea), and white mold (Sclerotinia
spp.) in ginseng is up to 4-6 broadcast applications (with the first
made when disease first appears, or when conditions are favorable for
disease development) at rates of 0.52-0.78 lb ai/A, with subsequent
applications repeated (as needed) at 7- to 14-day RTIs.  Applications
should be made in a minimum spray volume of 100 gal/A.  The proposed
maximum total seasonal use rate is 3.1 lb ai/A, and the proposed minimum
PHI is 30 days.  

	In PP#6E7137, IR-4 has requested registration of fluazinam for use on
edible-podded beans (Subgroup 6-A, except peas), Brassica vegetables
(Group 5), and bushberries (Subgroup 13-B).  The proposed use pattern
for Omega 500F to control white mold (Sclerotinia sclerotiorum) and gray
mold (Botrytis cinerea) in edible-podded beans is up to two foliar
applications (with the first made when 10-30% of plants have at least
one open bloom) at rates of 0.26-0.45 lb ai/A per application (in water
volume adequate to provide coverage of foliage and flowers).  If need
be, a second application may be made at a 7- to 10-day RTI, for a
maximum total seasonal application rate of 0.90 lb ai/A, with a minimum
PHI of 14 days.  The proposed use pattern to control clubroot
(Plasmodiophora Brassicae) in Crop Group 5, Brassica (Cole) leafy
vegetables, is either:  

a single soil-drench application (immediately after transplanting
seedlings), made at a rate of 0.055 lb ai/1000 plants, prepared as a
solution of 6.45 fluid ounces of the EP in 100 gal of water, with 3.4
fluid ounces (100 mL) of solution applied per plant; or 

if desired, and for soil with low infiltration rates, a single
soil-incorporation application (immediately prior to transplanting
seedlings), made at a rate of 1.35 lb ai/A in a minimum bandwidth of 9
inches along the planting row, and incorporated to a soil depth of 6-8
inches, in a minimum water volume of 50 gal/A.  If planting into a bed,
a broadcast application may be made prior to forming the bed.  

The proposed maximum total seasonal use rate is 2.0 lb ai/A, and the
proposed minimum PHI is 20 days for leafy greens, and 50 days for
heading vegetables.  The proposed use pattern to control twig
blight/fruit rot (Phomopsis vaccinii), anthracnose ripe rot
(Colletotrichum acutatum and Colletotrichum gloeosporiaoides), and
botrytis fruit rot (Botrytis cinerea) in bushberries is up to 6 foliar
applications at a rate of 0.65 lb ai/A per application (in water volume
adequate to provide coverage of foliage, flowers, and fruit).  The first
application should be made at the green tip stage, with subsequent
applications repeated at 7- to 10-day RTIs (roughly corresponding to
applications at pink tip, early bloom, full bloom, blossom drop, and
small green fruit to some blue fruit).  The proposed maximum total
seasonal use rate is 3.9 lb ai/A, and the proposed minimum PHI is 30
days.  

	Applications of Omega 500F are to be made using ground equipment or
chemigation (application via irrigation equipment) only.  Aerial
application of this EP is prohibited.  

Table 3.	Summary of Directions for Use of Fluazinam.

Application Timing; Type; and Equipment 1	Form-ulation 2

	Use Rate

(lb ai/A)	Maximum # of Uses per Season	Maximum Seasonal Use Rate (lb
ai/A)	PHI

(Days)	Use Directions and Limitations

Shelled Succulent and Dried Beans

At 10-30% bloom; foliar; spray.	Omega 500F

≥9”, soil depth 6-8”. Spray volume ≥ 50 gal/A.

Prior to forming bed; broadcast; spray.

2.0

Spray volume ≥ 50 gal/A.

Bushberries

1Green tip, 2pink tip, 3early bloom, 4full bloom, 5blossom drop, 6small
green fruit/some blue fruit; foliar; spray.	Omega 500F	0.65	6	3.9	30	RTI
= 7-10 days.  Volume adequate to cover foliage, flowers, and fruit.

1. Applications of Omega 500F are to be made using ground equipment or
chemigation (application via irrigation 	equipment) only.  Aerial
application of this EP is prohibited.  

2. Omega 500F is a flowable suspension concentrate containing 4.17
lb/gal of fluazinam.  

3. PHI = 20 days for Brassica leafy greens, and 50 days for Brassica
heading vegetables.  

	Conclusion:  The proposed label directions are adequate, and are
supported by the available field trial data.  The product label for
Omega 500F should be amended to include a restriction, stating that
turnip roots from turnip plants treated with this EP must not be used
for human nor livestock consumption.  

860.1300	Nature of the Residue – Plants

	  SEQ CHAPTER \h \r 1 MARC Decision Memo D272624; William Cutchin;
4/23/2001

	Residue Chemistry Memo D257115; William Cutchin; 5/21/2001

	  SEQ CHAPTER \h \r 1 The nature of the residue in plants has been
adequately delineated, based on acceptable potato, peanut, and grape
metabolism studies reviewed previously (D257115; William Cutchin;
5/21/2001), along with an acceptable apple metabolism study submitted
recently (MRID #46991301).  The metabolism of fluazinam appears to be
similar in potatoes, peanuts, grapes, and apples.  Fluazinam undergoes
reduction of one of the nitro groups to an amine, forming AMPA.  AMPA
may then be conjugated with glutathione, with subsequent degradation of
the glutathione moiety to cysteine.  The AMPA-cysteine conjugate then
undergoes transamination, reduction, and conjugation with glucose to
form AMGT.  In addition, both rings of fluazinam appear to be labile to
ring cleavage, and subsequent degradation of the rings into small
fragments that may then be incorporated into a variety of natural plant
components.  At a meeting held on 11/28/2000, HED concluded that the ROC
in potatoes and peanuts (for both tolerance expression and dietary risk
assessment purposes) was the parent compound only (D272624; William
Cutchin; 4/23/2001).  In wine grapes, both parent and AMGT were included
in the ROC for tolerance expression and risk assessment.  Additionally,
HED determined that data generated for potential new uses on other crops
(with the exception of root and tuber, and bulb vegetables) should
include analyses for both parent and AMGT.  

860.1300	Nature of the Residue - Livestock

	  SEQ CHAPTER \h \r 1 MARC Decision Memo D272624; William Cutchin;
4/23/2001

	Residue Chemistry Memo D257115; William Cutchin; 5/21/2001

	The nature of the residue in livestock is also understood, based on
adequate goat and hen metabolism studies (D257115; William Cutchin;
5/21/2001).  The metabolism of [14C]-fluazinam in ruminants and poultry
is similar, and involves reduction of one or both nitro groups on the
phenyl ring to form AMPA, MAPA, or DAPA.  Fluazinam also undergoes
dehalogenation and hydroxylation of the chlorine on the phenyl ring to
form HYPA.  These compounds may then undergo conjugation with
glutathione, and subsequent degradation of the glutathione component
yields a variety of polar compounds.  Although the ring structure of the
parent molecule remains intact, fluazinam per se was only a minor
component (≤2.7% TRR) of the [14C]-residues in poultry tissues and
eggs, and was not detected in ruminant tissues or milk.  The fluazinam
residues of regulatory interest in animals were determined by HED to be
parent plus the metabolites AMPA and DAPA, and their sulfamate
conjugates.  

 

860.1340	Residue Analytical Methods – Plants

	PMV Results Memo D266802; Paul Golden; 6/22/2001

	Fluazinam:  The tolerance-enforcement method, Fluazinam:  Method for
the Analysis in Peanut Nut Meat (MRID #43521016), was adequately
radiovalidated.  This GC/ECD method for determining residues of
fluazinam per se was originally reviewed in conjunction with the
time-limited tolerance petition for peanuts (D177127 and D177137; George
Herndon; 6/19/1992).  In brief, residues of fluazinam are extracted from
crop samples with MeOH/acetic acid (HOAc) (50:1, v/v), filtered,
acidified with 0.2N HCl, and partitioned into hexane.  Residues are then
partitioned into 0.5N NaOH, the aqueous phase is acidified, and residues
are partitioned back into hexane.  The resulting hexane fraction is
concentrated, and residues are purified using a Florisil column, then
analyzed by GC/ECD.  The petitioner achieved adequate recoveries of
fluazinam from peanut nutmeat samples fortified with fluazinam at
0.010-1.00 ppm.  

	This method has undergone a successful ILV trial (D212612, D216941, and
D217467; George Herndon; 9/5/1995) using peanut nutmeats fortified with
fluazinam at 0.010, 0.020, and 0.050 ppm.  Recoveries at the 0.010 ppm
level were low (56% and 68%) owing to an interference peak; therefore,
the validated LOQ would be 0.020 ppm.  However, the independent
laboratory noted that the method could possibly be improved in the
Florisil clean-up step.  The method was forwarded to ACB for a PMV
trial, and was subsequently determined to be suitable as a
tolerance-enforcement method (D266802; Paul Golden; 6/22/2001).  

	The submitted GC/ECD methods (modifications of the
tolerance-enforcement method) are adequate for collecting data on
residues of fluazinam per se in the various crop commodities associated
with this petition.  The LLMV and/or LOQ for residues of fluazinam per
se were 0.010 ppm in all plant matrices except snap beans and lima
beans, in which the LLMV and LOQ were 0.020 ppm.  

	AMGT:  The submitted HPLC/UV method (a working method based on Method
Evaluation for the Analysis of AMGT in Grapes, MRID #45593101) is
adequate for collecting data on AMGT residues in blueberries. 
Blueberries were blended with acetonitrile (ACN)/water (4:1, v:v), and
filtered.  The filter paper with contents was extracted a second time. 
The combined solvent extract was then concentrated by evaporation.  The
sample was partitioned with 2% aqueous Na2SO4 and methylene chloride. 
The aqueous layer was acidified to a pH of <1 with 6N HCl, then
partitioned twice with EtOAc, and the organic phase was evaporated to
dryness.  The aqueous sample was applied to a C18 SPE column, and AMGT
was eluted with ACN/water (3:7; v:v).  After evaporation to dryness, the
sample was taken up in ACN/H2O/HOAc, and filtered through a 0.45 µm
PTFE disc prior to analysis by HPLC/UV at 256 nm.  The LLMV, LOD, and
LOQ were 0.020, 0.013, and 0.038 ppm, respectively, for residues of AMGT
in blueberries.  HED has previously determined that residues of AMGT are
to be regulated in wine grapes (D272624; William Cutchin; 4/23/2001). 
The Agency therefore requested that this method undergo an ILV trial,
and, potentially, a PMV trial by the ACB.  An ILV study has not yet been
submitted.  

	Conclusion:  The CG/ECD methods, based on the tolerance-enforcement
method, are adequate for collecting data and enforcing tolerances for
fluazinam residues in the various crop commodities associated with this
petition.  The submitted HPLC/UV method is adequate for collecting data
and enforcing tolerances for AMGT residues in blueberries.  As a
condition of registration, an ILV for the AMGT analytical method (with
wine grapes) should be submitted by the registrant.  If the registrant
agrees with the modifications made by Ricerca to the original method (in
MRID #45593101), these modifications should be incorporated into a
revised method for the ILV.  Sample sets should include, at minimum, 2
control (untreated) samples of wine grapes, 2 samples fortified at the
tolerance level (3.0 ppm), and 2 samples fortified at the LOQ (0.010
ppm).  

860.1340	Residue Analytical Methods – Livestock

	As there are currently no tolerances established in livestock
commodities, and none are needed as a result of the requested uses,
residue analytical methods for livestock commodities are not required.  

860.1360	Multiresidue Methods

	Data depicting the analysis of fluazinam through FDA MRM Protocols were
submitted, and have been forwarded to FDA for review (Letter from
William Cutchin to Mark Wirtz; 8/16/2000).  The MRM testing data
indicate that fluazinam is partially recovered through Sections 302,
303, and 304 of PAM Volume I, with its recovery being dependent on which
Florisil elution system is used.  The MRMs can serve as a confirmatory
procedure for residues of fluazinam.  As a condition of registration,
MRM data should also be provided for the metabolite AMGT, since it is
included in the tolerance expression for grapes.  

860.1380	Storage Stability

≤LOQ (≤0.010 ppm).  At the time of submission, the freezer storage
stability analyses were not completed for the AAFC cabbage field trial. 
A final report is expected shortly.  Pending submission of the final
report for AAFC Project AAFC03-066R, the storage stability data
generated for IR-4 Project 08796 are adequate to support the storage
conditions and durations of the cabbage samples from the AAFC field
trial.  

TABLE 4.	Summary of Storage Conditions.

Crop [Matrix]	Analyte	Storage Temperature (°C)	Actual Storage Duration
(Days)	Interval of Demonstrated Storage Stability (Days)

Blueberry [Berry]	Fluazinam	-21 ± 7	162	203

	AMGT

229	251

TABLE 5.	Summary of Storage Conditions. 

Crop [Matrix]	Storage Temperature (°C)	Actual Storage Duration (Days)
Interval of Demonstrated Storage Stability (Days)

Snap Bean [Succulent Seed with Pod]	-38 to -1 1	377	377

Broccoli [Flower Head & Stem]

(IR-4 Project 08795)	-21 ± 7	146	205

Broccoli [Flower Head & Stem]

(AAFC Project AAFC03-018)	-26.3 to -10.2	179	232

Cabbage [Head with Wrapper Leaves]

(IR-4 Project 08796)	-23 to -4	560	560 2

Cabbage [Head with Wrapper Leaves]

(AAFC Project AAFC03-066R)	<-16.7	180	Interim report only; refer to SS
data for IR-4 Project 08796.

Mustard Greens [Leaves]

(IR-4 Project 08797)	-23 to -4	621	580 3

Ginseng [Dried Root]	-21 ± 7	332	347 4

Dried Bean [Shelled Dried Seed]	-38 to –1	245	307 5

Lima Bean [Shelled Succulent Seed]	-38 to -1	254	455 6

1. Except for one 6-hour period at 6ºC, owing to compressor failure.  

2. Results from the concurrent freezer storage stability studies
indicated that significant dissipation of residues 	occurred (~70%)
during the storage interval.

3. Results from the concurrent freezer storage stability studies
indicated that significant dissipation of residues 	occurred (~55%)
during the storage interval.

4. Results from the concurrent freezer storage stability studies
indicated that significant dissipation of residues 	occurred (~30%)
during the storage interval.

5. Results from the concurrent freezer storage stability studies
indicated that significant dissipation of residues 	occurred (~45%)
during the storage interval.

6. Results from the concurrent freezer storage stability studies
indicated that significant dissipation of residues 	occurred (~40%)
during the storage interval.

	Conclusion:  The available data adequately support the storage
durations and conditions for the current blueberry, snap bean, and
Brassica field trials.  To account for dissipation during frozen
storage, correction factors have been incorporated into the recommended
tolerances for fluazinam residues in ginseng, shelled succulent beans,
and shelled dried beans.  

860.1400	Water, Fish, and Irrigated Crops

	This guideline requirement is not relevant to the current petitions, as
the proposed uses are non-aquatic.  

860.1460	Food Handling

	This guideline requirement is not relevant to the current petitions, as
no uses are being proposed for food/feed handling establishments.  

860.1480	Meat, Milk, Poultry, and Eggs

	This guideline requirement is not relevant to the current petitions, as
there are currently no tolerances established in livestock commodities,
and there are no significant livestock feed items associated with the
proposed uses.  

860.1500	Crop Field Trials

	DER for MRID #46986701 (Blueberry)

	Blueberry:  Thirteen magnitude of the residue trials were conducted in
Canadian and US growing regions (in 2003-2004) for fluazinam on
blueberries.  Four trials were located in Canada in Region 1A (2 in
Prince Edward Island, 1 in Nova Scotia), and Region 5A (1 in Quebec). 
Nine trials were located in the US in Region 1 (1 in Maine), Region 2 (2
in New Jersey, 1 in North Carolina), Region 5 (US)/5A (Canada) (3 in
Michigan), Region 11 (1 in Washington), and Region 12 (1 in Oregon). 
Fluazinam was applied as six foliar applications (at rates of 0.62 to
0.72 lb ai/A per application) to blueberries with RTIs of 3-9 days, for
total seasonal use rates ranging from 3.83 to 4.05 lb ai/A.  There were
2 treated plots at each site (except in NS), with the applications in
one plot timed to harvest at a 30-day PHI, and the applications in the
second plot timed to harvest at a 50-day PHI.  At the NS trial, only the
30-day PHI regime was conducted.  Applications were made using ground
equipment, in spray volumes of 30.2 to 61.4 gallons per acre (GPA);
spray adjuvants were not used at any of the trial sites.  

	Residue analysis for fluazinam in blueberries was conducted using an
analytical method entitled Fluazinam:  Method for the Analysis in Peanut
Nut Meat (MRID #43521016).  Residue analysis for the metabolite AMGT was
conducted using Method Evaluation for the Analysis of AMGT in Grapes
(MRID #45593101).  Concurrent recoveries were measured in samples
fortified with fluazinam at 0.010 ppm, 0.100 ppm, 1.00 ppm, and 3.00 ppm
(1X, 10X, 100X, and 300X the LLMV), and in samples fortified with AMGT
at 0.020 ppm, 0.100 ppm, 0.200 ppm, and 1.00 ppm (1X, 5X, 10X, and 50X
the LLMV).  Individual recoveries of fluazinam (n = 31) ranged from
60-140% across all spike levels, while recoveries of AMGT (n = 35)
ranged from 58-125%.  At each fortification level, average recoveries
were within the generally recognized acceptable range (70-120%) except
for 4 samples spiked with 0.010 ppm fluazinam (140, 60, 66, and 140%
recovery), 1 sample spiked with 1.00 ppm fluazinam (140% recovery), 2
samples spiked with 0.020 ppm AMGT (125 and 65% recovery), and 3 samples
spiked with 0.100 ppm AMGT (58, 68, and 68% recovery).  Overall, peaks
were well-defined and symmetrical in all chromatograms.  Untreated
control sample chromatograms for fluazinam were free from interference
above the chromatographic background.  Three untreated control samples
showed identifiable peaks at or near the retention time for AMGT
(ranging from 0.0333 to 0.1307 ppm).  Treated sample chromatograms
showed analyte peaks within the area of analytical interest; no
carryover was observed in control samples.  Detector linearity for
fluazinam was demonstrated across the range of residues (r2 >0.9834). 
Calibration curves were not provided for AMGT.  

	The number and geographical distribution of the blueberry field trials
were in accordance with OPPTS Residue Chemistry Test Guideline 860.1500.
 Since the petitioner is also seeking registration of fluazinam for use
on bushberries in Canada, additional field trials were conducted in the
Canadian provinces of Prince Edward Island, Nova Scotia, and Quebec.  

	Treated and control blueberry samples were stored frozen (at -21 ±
7°C) for durations of up to 162 days (fluazinam) and 229 days (AMGT). 
A concurrent freezer storage stability study was conducted in blueberry
samples fortified with fluazinam (at 0.10 ppm) and AMGT (at 0.15 ppm). 
Residues in the concurrent freezer storage stability samples remained
stable for intervals of 203 days (fluazinam) and 251 days (AMGT). 
Therefore, there are no concerns with the stability of residues over
time in this study.  

	Residues of fluazinam (summarized in Table 6, below) in treated
blueberry samples ranged from 0.064 to 2.0 ppm, and residues of AMGT
ranged from 0.025 to 0.13 ppm (with combined residues of 0.166-2.094
ppm) at the target PHI of 30 days (23-32 days).  Residues of fluazinam
ranged from 0.017-1.1 ppm, and residues of AMGT ranged from <0.020-0.12
ppm (with combined residues of 0.054-1.164 ppm) at the target PHI of 50
days (43-51 days).  At three of the trial sites, residue behaviour was
also assessed 7 or 8 days after the initial samples were harvested (PHI
of 38 or 39 days).  At two of the three sites (03-NJ32, 03-NJ33),
residues declined with longer PHIs, but residues increased with the
longer PHI at the third site (03-MI34). 

TABLE 6.	Summary of Residue Data from Blueberry Field Trials with
Fluazinam.

Crop [Matrix]	Total Use Rate 

(lb ai/A)	PHI (Days)	Residue Levels (ppm)

	n	Min.	Max.	HAFT 1	Median	Mean	Std. Dev.

Fluazinam

Blueberry [Berry]	3.79-4.07	23-32	23 2	0.064	2.0	1.8	0.55	0.740	0.61

	3.83-4.22	38-39	6	0.22	0.42	0.38	0.28	0.30	0.070

	3.83-4.03	43-51	23	0.017	1.1	0.98	0.16	0.272	0.279

AMGT

Blueberry [Berry]	3.79-4.07	23-32	23 2	0.025	0.13	0.125	0.084	0.08	0.032

	3.83-4.22	38-39	6	0.032	0.17	0.165	0.04	0.080	0.066

	3.83-4.03	43-51	23	<0.020 3	0.12	0.11	0.056	0.055	0.030

Combined Residues (Fluazinam and AMGT)

Blueberry [Berry]	3.79-4.07	23-32	23 2	0.166	2.094	1.902	0.622	0.820
0.600

	3.83-4.22	38-39	6	0.296	0.463	0.42	0.379	0.380	0.069

	3.83-4.03	43-51	23	0.054	1.164	1.047	0.214	0.327	0.284

1. HAFT = Highest Average Field Trial.  

2. Values from NS01 trial were not included because the application rate
was 1.5X the target rate.  

3. Residue results of <LOQ were assigned a value of the LOQ for the
purpose of calculating the mean, median, and 	standard deviation.

	DER for MRID #46986702 (Snap Bean)

	Snap Bean:  Eleven supervised magnitude of the residue trials were
conducted with fluazinam on snap beans in Canada and the US during the
2003 and 2004 growing seasons.  Beans were grown and harvested according
to common agricultural practices.  Details of trial site history and
plot maintenance were provided.  Each trial site consisted of two
treated plots.  The first treated plot received a single foliar
application of fluazinam, formulated as a flowable suspension
concentrate, at rates of 0.444 to 0.495 lb ai/A, and mature beans were
harvested at PHIs ranging from 14-28 days.  The second treated plot
received two foliar applications at 2- to 6-day RTIs, at rates of 0.422
to 0.469 lb ai/A per application, for total seasonal use rates of 0.881
to 0.921 lb ai/A.  Mature beans from these plots were harvested at PHIs
of 10-22 days.  At two trial sites, samples were harvested at two
additional PHIs around the target PHI of 14 days (10-11 days and 20
days).  Applications were made using ground equipment, in spray volumes
of 19.8 to 46.7 GPA; spray adjuvants were not used at any of the field
trial sites.  

	It was noted that at one trial site (03-NY18), the second treatment
protocol (involving two applications) was discontinued, as the second
application was made well beyond the study protocol target.  No further
details were provided.  According to IR-4 Protocol #07602, “timing for
application in this study is critical and is based on % plants with open
blooms.”  The protocol specified that, for a single treatment,
application was to occur “at first bloom to 30% bloom,” while for
two treatments, the first application was to occur “at first bloom to
10% bloom,” and the second application 4-7 days later, but “no later
than 50% bloom.”  Field data summaries provided for the trial sites
(specifically 03-MI39, 03-MI40, 03-WA20, and 03-QC12) indicated that
several applications were not conducted according to this timing
protocol.  However, as the majority of these trials had mature samples
harvested at or near the target PHI of 14 days, with residue results
consistent with those from other trials which were treated according to
the study protocol, the reviewer concluded that these discrepancies in
application timing did not affect the residue results reported.  

ntative chromatograms were provided for fluazinam over the range of
0.0010 to 0.0100 μg/mL.  The detector response was linear, with r2
values reported as 0.972 or greater.  

	The number and geographical distribution of the snap bean field trials
were in accordance with OPPTS Residue Chemistry Test Guideline 860.1500.
 Since the petitioner is also seeking registration of fluazinam for use
on edible-podded beans in Canada, additional field trials were conducted
in the Canadian provinces of Prince Edward Island and Quebec.  

	 Harvested beans were stored frozen for a maximum duration of 377 days
prior to extraction and analysis.  A concurrent freezer storage
stability study was conducted with snap beans fortified with fluazinam
at 1.00 ppm.  Uncorrected recoveries in these samples ranged from 58% to
69% after 377 days storage (n = 3; mean recovery 62%).  When recoveries
were corrected for concurrent recovery (75%; n = 1), the mean recovery
was 83% (77% to 92%), indicating that residues of fluazinam in snap
beans did not decline significantly over the storage interval. 
Therefore, there are no concerns associated with the stability of
fluazinam residues over time in this study.  

	Residues of fluazinam determined in snap beans are summarized in Table
7 (below).  The maximum residue observed in snap beans treated with a
single application of fluazinam at 0.444 to 0.495 lb ai/A, and harvested
at PHIs of 14-28 days, was 0.029 ppm, detected in a single sample.  All
remaining samples had residues below the LOQ (<0.020 ppm).  The maximum
residue observed in snap beans treated with two applications of
fluazinam, at total application rates of 0.881 to 0.921 lb ai/A, and
harvested at PHIs of 10-22 days, was 0.109 ppm.  At two trial sites,
samples were harvested at two additional PHIs surrounding the target PHI
of 14 days (10-11 days and 20 days).  Results from these trials
indicated that residues of fluazinam in snap beans decreased with
increasing PHIs, reaching levels <LOQ (<0.020 ppm) by 20 days.  

TABLE 7.	Summary of Residue Data from Snap Bean Field Trials with
Fluazinam

Crop [Matrix]	Total Use Rate

(lb ai/A)	PHI (Days)	Residue Levels 1 (ppm)

	n	Min.	Max.	HAFT 2	Median	Mean	Std. Dev.

Snap Bean [Succulent Seed with Pod]	0.444-0.495	14-17	8	<0.020	0.029
0.025	0.020	0.021	0.003

18-28	14	<0.020	<0.020	<0.020	<0.020	<0.020	0

	0.881-0.921	10	2	0.046	0.072	0.059	0.059	0.059	--

11-15	16	<0.020	0.109	0.080	0.021	0.038	0.030

20-22	10	<0.020	<0.020	<0.020	<0.020	<0.020	0

1. Residue results of <LOQ were assigned a value of the LOQ for the
purpose of calculating the mean, median, and 	standard deviation.

2. HAFT = Highest Average Field Trial.

	DER for MRIDs #46996601 & -02, 46986705 to -07 (Broccoli, Cabbage,
Mustard Greens)

	Broccoli, Cabbage, Mustard Greens, Turnip Leaves:  Thirteen supervised
magnitude of the residue trials were conducted with fluazinam on
broccoli, 12 trials were conducted with fluazinam on cabbage, and 11
trials were conducted with fluazinam on mustard greens in Canada and the
US during the 2003, 2004, and 2005 growing seasons.  As discussed below,
it was not necessary to conduct field trials with turnip leaves. 
Brassica crops were grown and harvested according to common agricultural
practices.  Details of trial site history and plot maintenance were
provided.  Each trial site consisted of a single untreated (control)
plot, and a single treated plot.  Broccoli, cabbage, and mustard green
transplants were treated with a single root-drench application of
fluazinam, formulated as a flowable suspension concentrate, at a rate of
0.055 lb ai per 1000 plants, and mature crops were harvested at PHIs
ranging from 50-113 days (broccoli), 58-104 days (cabbage), and 22-78
days (mustard greens).  

	Residues of fluazinam from all field trials were determined using
working methods based on the GC/ECD Ricerca method Fluazinam:  Method
for the Analysis in Peanut Nut Meat (MRID #43521016).  Minor
modifications were made to the method to improve method performance. 
These modifications did not appear to affect the validity of the
analytical method.  The LLMVs (IR-4 studies) and LOQs (AAFC studies)
were reported as 0.010 ppm fluazinam in all matrices.  In the IR-4
studies, LODs were calculated based on the recoveries observed in crop
samples fortified with fluazinam at the method LLMV.  LODs were reported
as 0.0038 ppm for broccoli, 0.0033 ppm for cabbage, and 0.0037 ppm for
mustard greens.  LODs in the AAFC trials were reported as 0.003 ppm for
broccoli, and ~0.005 ppm for cabbage.  LOQs in these studies (calculated
as 3x the LODs) were reported as ~0.010 ppm fluazinam in all matrices. 
For all studies, representative chromatograms for standards, untreated
(control), treated, and fortification samples were provided in the
accompanying analytical reports.  Standard peaks were generally
symmetrical and well-defined.  Little or no interference was noted in
control samples.  Standard curves were provided for all studies
demonstrating linearity (all r2 values were ≥0.9674 for broccoli,
≥0.9710 for cabbage, and ≥0.9690 for mustard greens).  

	The number and geographical distribution of the Brassica field trials
were in accordance with OPPTS Residue Chemistry Test Guideline 860.1500.
 Since the petitioner is also seeking registration of fluazinam for use
on Brassica vegetables in Canada, additional field trials were conducted
in the Canadian provinces of Ontario, British Columbia, and Quebec.  

ncurrent recoveries ranged from 62% to 90% across both studies.  As
recoveries were usually within the generally recognized acceptable range
of 70% to 120%, and all SDs were ≤20%, the working methods are
considered reliable for the determination of fluazinam residues in
broccoli. 

	In IR-4 Study #08795, poor recoveries were initially obtained in method
validation samples fortified with 0.100 ppm fluazinam.  According to the
study report, it was thought that poor recoveries at this fortification
level were due to a matrix “quenching” effect.  When samples were
diluted 10-fold, recoveries improved on average by 26%.  Subsequently,
all 0.100 ppm fortified samples in this trial (method validation and
concurrent validation samples) were diluted prior to extraction and
analysis.  

	Treated broccoli samples were stored frozen for durations of up to 146
days in the IR-4 trials, and 179 days in the AAFC trials.  Freezer
storage stability of residues in broccoli was determined concurrently in
both trials, using samples fortified with fluazinam at 0.100 ppm.  In
IR-4 Study #08795, initial analysis of the storage stability samples
(182 days after storage) indicated that residues had significantly
dissipated during storage (recoveries ranged from 20% to 34%).  However,
it was also noted that concurrent recoveries for these analyses were not
acceptable (≤49%).  Following approval from the study director, the
storage stability samples were diluted 10-fold, which significantly
improved concurrent recoveries.  The storage stability samples were
reanalyzed following dilution, and recoveries ranged from 39% to 68%. 
When corrected for mean concurrent recoveries (74% and 81% across both
days of analysis), freezer storage stability recoveries ranged from 53%
to 84%, indicating that residues of fluazinam did not degrade
significantly throughout the storage interval (205 days after initial
storage).  Storage stability samples from the AAFC trial were analyzed
232 days after initial storage.  Recoveries in these samples were low,
ranging from 50% to 52%.  Concurrent recoveries were also below the
generally recognized acceptable range of 70% (67%), but were considered
valid because recoveries within this range were also noted with treated
samples.  When adjusted for concurrent recoveries, storage stability
recoveries were acceptable (74% to 76%), indicating that residues of
fluazinam did not degrade significantly throughout the storage interval.
 Therefore, there are no concerns with the stability of residues of
fluazinam in broccoli throughout these trials.  

	Residues of fluazinam determined in broccoli are summarized in Table 8
(below).  No quantifiable (<LOQ; <0.010 ppm) or detectable (<LOD; <0.003
ppm) residues of fluazinam were reported in any broccoli sample
harvested 50 to 113 days after a single root-drench application of
fluazinam at the time of transplant, at a rate of 0.055 lb ai per 1000
plants.  Residue decline was not assessed in these trials.  

rom 76% to 113%, with all SDs ≤6.  Concurrent recoveries ranged from
78% to 103% in samples fortified at 0.010 ppm (IR-4, n = 11, SD = 16). 
Concurrent recoveries at additional fortification levels (0.050 ppm and
0.100 ppm) ranged from 66% to 125% across both studies.  As recoveries
were usually within the generally recognized acceptable range of 70% to
120%, and all SDs were ≤20%, the working methods are considered
reliable for the determination of fluazinam residues in cabbage.  

Treated cabbage samples were stored frozen for maximum durations of 560
days (IR-4 trials), and 180 days (AAFC trials).  The freezer storage
stability of residues in cabbage was determined concurrently in both
trials, using samples fortified with fluazinam at 0.100 ppm.  In IR-4
Study #08796, storage stability samples analyzed 560 days after initial
storage had recoveries ranging from 26% to 33%.  When corrected for
concurrent recovery (81%), recoveries ranged from 32% to 40%, indicating
that residues had dissipated significantly within the noted storage
interval.  At the time of submission, the freezer storage stability
analyses were not completed for the AAFC trial.  A final report is
expected shortly.  Pending submission of the final report for AAFC
Project AAFC03-066R, the storage stability data generated for IR-4
Project 08796 are adequate to support the storage conditions and
durations of the cabbage samples from the AAFC field trial.  

	Residues of fluazinam determined in cabbage are summarized in Table 8
(below).  No quantifiable (<LOQ; <0.010 ppm) or detectable (<LOD; <0.005
ppm) residues of fluazinam were reported in any cabbage sample harvested
58 to 104 days after a single root-drench application of fluazinam at
the time of transplant, at a rate of 0.055 lb ai per 1000 plants. 
Residue decline was not assessed in these trials.  

from 71% to 118% in samples fortified at 0.100 ppm.  As recoveries were
usually within the generally recognized acceptable range of 70% to 120%,
and all SDs were ≤20%, the working method is considered reliable for
the determination of fluazinam residues in mustard greens.  

	Treated mustard green samples were stored frozen for durations of up to
621 days.  The freezer storage stability of residues in mustard greens
was determined concurrently, in samples fortified with fluazinam at
0.100 ppm.  After 580 days, the storage stability samples showed
recoveries ranging from 40 to 52%.  Concurrent recoveries for the
freezer storage stability analyses were ~100%, so no correction was
applied to the freezer storage stability recoveries.  The low recoveries
in the freezer storage stability samples indicate that residues of
fluazinam degraded over the storage interval of the study.  While the
analysis interval (580 days) is somewhat shorter than the actual storage
duration for treated samples (621 days), it is within ±7% of the
maximum duration, and it is not expected that significantly greater
dissipation will have occurred during the additional ~40 days.  

	Residues of fluazinam determined in mustard greens are summarized in
Table 8 (below).  No residues above the LLMV (the maximum residue
observed was 0.010 ppm) were reported in any mustard greens sample
harvested 22 to 78 days after a single root-drench application of
fluazinam at the time of transplant, at a rate of 0.055 lb ai per 1000
plants.  Residue decline was not assessed in these trials.  

	Turnip Leaves:  Turnip field trials were not conducted because the
Agency will be including turnip leaves with the Brassica leafy
vegetables group in the near future.  Field trial data were submitted
for all the representative commodities of this group.  Therefore, field
trial data are not needed for turnip leaves.  

TABLE 8.	Summary of Residue Data from Brassica Vegetable Field Trials
with Fluazinam.

Crop [Matrix]	Total Use Rate

(lb ai/1000 plants)	PHI (Days)	Residue Levels 1  (ppm)

	n	Min.	Max.	HAFT 2	Median	Mean	Std. Dev.

Broccoli [Flower Head & Stem]	0.055	55-113	26	<0.010	<0.010	<0.010	0.010
0.010	0

Cabbage [Head + Wrapper Leaves]	0.055-0.056	60-104	24	<0.010	<0.010
<0.010	0.010	0.010	0

Mustard Greens [Leaves]	0.055	22-78	22	<0.010	0.010	0.010	0.010	0.010	0

1. Residues of fluazinam from the AAFC trials in broccoli and cabbage
were reported as <LOD (0.003 ppm in 	broccoli, and 0.005 ppm in
cabbage).  However, these residue results, along with those of <0.010
ppm from 	all other trials, were assigned a value of the LOQ (0.010 ppm
in all crops) for the purpose of calculating 	the mean, median, and
standard deviation.  

2. HAFT = Highest Average Field Trial.  

	DER for MRID #46990501 (Ginseng)

	Ginseng:  Four magnitude of the residue trials were conducted for
fluazinam on ginseng during the 2003 growing season.  The trials were
conducted in Michigan and Wisconsin (Region 5).  Each trial consisted of
one untreated control plot, and one treated plot.  At each trial, four
broadcast applications of fluazinam, formulated as a flowable suspension
concentrate, were made, with an RTI of 9-14 days.  The 1X rates ranged
from 0.756 to 0.936 lb ai/A per application, for total seasonal use
rates of 3.13 to 3.39 lb ai/A.  All 1X applications were made using
appropriate ground equipment in spray volumes of 175-251 GPA; spray
adjuvants were not used at any of the field trial sites.  The 2X rates
ranged from 1.58 to 1.73 lb ai/A per application, for a total seasonal
use rate of 6.61 lb ai/A.  All 2X applications were made using
appropriate ground equipment in spray volumes of 177-194 GPA; spray
adjuvants were not used.  At all field trials, mature ginseng was
harvested at a PHI of 29-31 days.  

Four applications of fluazinam were made, instead of the maximum of six
as allowed by the supplemental label use directions.  Although the
number of applications performed in the field trials was two fewer than
the supplemental label allowed, the proposed label’s maximum total
seasonal rate was applied.  

The samples were analyzed using a Cornell Analytical Laboratory Method,
entitled Residue Analysis of Fluazinam on Ginseng by GCEC Detection. 
Version #2.  This method is very similar to the Ricerca method
Fluazinam:  Method for the Analysis in Peanut Nut Meat (MRID #43521016).
 Minor modifications were made to improve the performance of the method.
 The validated LOQ was 0.009 ppm.  This method is adequate for data
collection, based on acceptable method recoveries.  Overall method
validation recoveries ranged from 62-110% from ginseng fortified with
fluazinam at 0.010-2.00 ppm.  Recoveries of samples fortified at the
LLMV (0.010 ppm) averaged 99% with a standard deviation of 10% (n = 9). 
One recovery spike at the LLMV of 0.010 ppm was 150%, and was considered
a statistical outlier after performing a “Q” Test (statistical
rejection of values test), and discussions with the Study Director. 
Recoveries of method validation samples fortified at 0.050 ppm averaged
69% with a standard deviation of 6% (n = 9), and one sample spiked at
0.050 ppm had a concurrent recovery result of 64%.  The low recoveries
of the 0.050 ppm fortifications might be due to some quenching of the
fluazinam by the matrix.  Detector linearity was satisfactory. 
Chromatograms of control (untreated) ginseng samples were
uncontaminated, and free from interferences (baseline detector response
was flat) at the retention time for fluazinam.  

The total number of field trials exceeded EPA recommendations; four
trials were performed, whereas only 3 are recommended.  All 4 trials
were performed in Region 5.  OPPTS Residue Test Chemistry Guideline
860.1500 does not specify where the trials should be performed.  

	Fluazinam residues were relatively unstable in ginseng over the storage
durations of the field trial studies.  Storage stability samples were
extracted and analyzed after intervals of up to 339 days of freezer
storage.  The fluazinam recoveries from the storage stability samples
ranged from 42% to 49%.  After correction for concurrent recoveries,
these storage stability recoveries ranged from 65% to 72%.  Ginseng
samples from the field trials were stored for a maximum duration of 332
days.  

A summary of the residue data for ginseng is presented in Table 9
(below).  In the trials performed at the 1X and 2X application rates,
the residues of fluazinam in ginseng ranged from 0.28 to 1.4 ppm, and
2.1 to 2.2 ppm, respectively.  The storage stability study, however,
raises the possibility that actual residues in ginseng (at harvest) were
up to 50% greater than the quantitated results, based on in-storage
dissipation of fluazinam.  

TABLE 9.	Summary of Residue Data from Ginseng Field Trials with
Fluazinam.

Crop [Matrix]	Total Use Rate

(lb ai/A)	PHI (Days)	Residue Levels  (ppm)

	n	Min.	Max.	HAFT*	Mean	Std. Dev.

Ginseng [Dried Root]	3.13-3.39	29-31	8	0.28	1.4	1.3	0.82	0.38

	6.61	29	2	2.1	2.2	2.15	2.2	0.071

* HAFT = Highest Average Field Trial.  

	DER for MRID #46990502 (Dried Beans)

	Dried Beans:  Thirteen magnitude of the residue trials were conducted
for fluazinam on dried beans, 12 during the 2003 growing season, and 1
during the 2004 growing season.  The trials were conducted in Region 1
(New York), Region 5 (MI, WI, SD, ND) Region 7 (ND), Region 8 (CO),
Region 9 (CO), Region 10 (CA), and Region 11 (ID and WA).  At each
trial, one foliar application of fluazinam, formulated as a flowable
suspension concentrate, was made at early bloom, and a second
application was made about 14 days later.  The applications were made at
rates of 0.432-0.481 lb ai/A per application, for total seasonal use
rates of 0.871-0.960 lb ai/A.  Applications were made using ground
equipment, in spray volumes of 18-35 GPA; spray adjuvants were not used
at any of the field trial sites.  Mature dried beans were harvested at a
PHI of 31-57 days.  

Samples were analyzed for fluazinam using a procedure derived from the
Ricerca method (MRID #43521016), Fluazinam:  Method for the Analysis in
Peanut Nut Meat.  Minor modifications were made to improve the
performance of the method.  The validated LOQ was 0.009 ppm.  This
method is adequate for data collection, based on acceptable method
recoveries.  Overall recoveries ranged 71-108% from dried beans
fortified with fluazinam at 0.010-1.04 ppm.  Recoveries at the LLMV
(0.010 ppm) averaged 84% with a standard deviation of 11% (n = 16). 
Recoveries at fortifications of 0.010-1.04 ppm averaged 88% with a
standard deviation of 11% (n = 23).  Detector linearity was
satisfactory.  Chromatograms of control (untreated) dried bean samples
were uncontaminated, and free from interferences (baseline detector
response was flat) at the retention time for fluazinam.  

The total number of field trials exceeded EPA recommendations, but the
geographical distribution of the dried bean field trials was,
technically, not in accordance with the guidance (OPPTS Residue Test
Chemistry Guideline 860.1500).  One additional dried bean field trial
was performed in both Regions 5 and 11, but one fewer trial was
performed in Region 7 than recommended by the Guidelines.  

Fluazinam residues were relatively unstable in dried beans over the
storage durations of the field trial studies.  After a storage interval
of 307 days, fluazinam residues in fortified dried bean samples declined
to 52% of the fortification level.  Recoveries from method validation
and concurrent recovery samples averaged 88%.  Dried bean samples from
the field trials were stored for a maximum duration of 245 days.  

A summary of residue data for dried beans is presented in Table 10
(below).  Fluazinam residues were less than the LLMV (<0.010 ppm) in all
dried bean samples from the field trials, except for one sample at
0.0114 ppm.  The storage stability study, however, raises the
possibility that actual residues in dried beans (at harvest) were up to
50% greater than the quantitated results, based on in-storage
dissipation of fluazinam.  

TABLE 10.	Summary of Residue Data from Dried Bean Field Trials with
Fluazinam.

Crop [Matrix]	Total Use Rate

(lb ai/A)	PHI (Days)	Residue Levels (ppm)

	n	Min.	Max.	HAFT*	Median	Mean	Std. Dev.

Bean [Shelled Dried Seed]	0.871-0.960	31-57	26	<0.010	0.0114	0.0107
0.010	0.0101	0.00027

* HAFT = Highest Average Field Trial.

	DER for MRID #46990503 (Lima Bean)

	Lima Bean:  Seven magnitude of the residue trials were conducted for
fluazinam on lima beans during the 2003 and 2004 growing seasons.  The
trials were conducted in New Jersey, Maryland, and Georgia (Region 2),
California (Region 10; 2 trials), and Idaho (Region 11; 2 trials).  Each
trial consisted of one control (untreated) plot, and one treated plot. 
At each trial, two foliar applications of fluazinam, formulated as a
flowable suspension concentrate, were made.  The first application was
made at first bloom to 10% bloom, and the second was made about 3-7 days
later, but no later than 55% bloom.  Applications were made at rates of
0.441-0.459 lb ai/A per application, for total seasonal use rates of
0.885-0.912 lb ai/A.  All applications were made using ground equipment,
in spray volumes of 19.7-48.9 GPA; spray adjuvants were not used at any
of the field trial sites.  Mature lima beans were harvested at a PHI of
28-71 days.  

Samples were analyzed for fluazinam using a procedure derived from the
Ricerca method (MRID #43521016), Fluazinam:  Method for the Analysis in
Peanut Nut Meat.  Minor modifications were made to improve the
performance of the method.  The validated LOQ was 0.020 ppm.  This
method is adequate for data collection, based on acceptable method
validation and concurrent recoveries.  

Overall recoveries ranged 71-107% from lima beans fortified with
fluazinam at 0.020-1.00 ppm.  Recoveries from samples fortified at the
LLMV (0.020 ppm) averaged 83% with a standard deviation of 13% (n = 11).
 The average recovery of all fortifications was 82% with a standard
deviation of 11% (n = 18).  Detector linearity was satisfactory. 
Chromatograms of control (untreated) lima bean samples were
uncontaminated, and free from interferences (baseline detector response
was flat) at the retention time for fluazinam.  

The total number of field trials exceeded EPA recommendations, but the
geographical distribution of the lima bean field trials was,
technically, not in accordance with the guidance (OPPTS Residue Test
Chemistry Guideline 860.1500).  One additional lima bean field trial was
performed in both Regions 10 and 11, but one fewer trial was performed
in Region 5 than recommended by the Guidelines.  

Fluazinam residues were relatively unstable in lima beans over the
storage durations of the field trial studies.  After a storage interval
of 455 days, fluazinam residues in fortified lima bean samples had been
reduced to 51% of the fortification level.  Recoveries from method
validation and concurrent recovery samples averaged 82%.  Lima bean
samples from the field trials were stored for a maximum duration of 254
days.  

	A summary of residue data for lima beans is presented in Table 11
(below).  Fluazinam residues were less than the LOQ (<0.020 ppm) in all
lima bean samples from the field trials.  The storage stability study,
however, raises the possibility that actual residues in lima beans (at
harvest) were up to 50% greater than the quantitated results, based on
in-storage dissipation of fluazinam.  

TABLE 11.	Summary of Residue Data from Lima Bean Field Trials with
Fluazinam.

Crop [Matrix]	Total Use Rate

(lb ai/A)	PHI (Days)	Residue Levels (ppm)

	n	Min.	Max.	HAFT*	Median	Mean	Std. Dev.

Lima Bean [Shelled Succulent Seed]	0.885–0.912	28-71	14	<0.020	<0.020
<0.020	<0.020	<0.020	0

* HAFT = Highest Average Field Trial.

	Conclusions:  The field trial data are adequate, and support the
proposed use patterns.  Adequate numbers of trials were conducted in the
appropriate geographical regions, and samples were analyzed for the ROC
using adequate methods.  The sample storage conditions and durations are
supported by the available storage stability data.  However, residue
data for AMGT were provided only for blueberries; AMGT data should also
have been included with the field trial studies for edible-podded beans,
shelled succulent and dried beans, and Brassica vegetables.  The Agency
has previously determined, and the registrant is hereby advised again,
that residue data for AMGT should be provided in the crop field trial
studies for all future requested plant commodities, except root and
tuber, and bulb vegetables.  

860.1520	Processed Food and Feed

	This guideline requirement is not relevant to the current petitions, as
there are no processed commodities for which residue data are required
associated with the proposed uses on the crops requested in the subject
petitions under review.  

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

	An analytical reference standard for fluazinam is available (as of
7/2/2007) in the inventory at the EPA National Pesticide Standards
Repository.  However, the certificate of analysis (COA) expired on
4/17/2007.  NPSR will request another fluazinam standard, or request a
new COA (for the current standard) from the manufacturer.  

860.1850	Confined Accumulation in Rotational Crops

	Regulatory requirements pertaining to fluazinam residues in rotational
crops have been fulfilled, and the rotational crop restrictions on the
proposed label are adequate.  

  SEQ CHAPTER \h \r 1 860.1900	Field Accumulation in Rotational Crops

	Regulatory requirements pertaining to fluazinam residues in rotational
crops have been fulfilled, and the rotational crop restrictions on the
proposed label are adequate.  

860.1550	Proposed/Recommended Tolerances

	For the purpose of setting tolerances, the Agency has determined that,
apart from wine grapes, fluazinam is the ROC in both primary and
rotational crops.  The proposed and recommended tolerances for the
various commodities requested in the current petitions are listed in
Table 12 (below).  

	Bushberries (Subgroup 13-B):  The representative commodity of the
bushberry crop subgroup is highbush blueberry.  Residue data inputs from
the blueberry field trials (for samples with 23- to 32-day PHIs)
resulted in an MRL/tolerance calculator recommendation of a 7.0 ppm
tolerance for fluazinam on bushberries.  Separate individual tolerances
are also listed for fluazinam in the future members of the bushberries
subgroup 13-B, as approved by ChemSAC.  

	Edible-Podded Beans (Subgroup 6-A, Except Peas):  The representative
bean commodity of subgroup 6-A is one succulent cultivar of
edible-podded bean which, in this case, was snap bean.  Approximately
80% of fluazinam residues were <LOQ (<0.010 ppm), so the MRL/tolerance
calculator was not used.  Based on the maximum residue (at an 11-day
PHI) of 0.109 ppm (HAFT = 0.080), and a proposed minimum 14-day PHI, HED
recommends that the tolerance for fluazinam in Subgroup 6-A (except
peas) be set at 0.10 ppm.  

	Brassica (Cole) Vegetables (Group 5):  The representative commodities
of the Brassica crop group are broccoli, cabbage, and mustard greens. 
Fluazinam residues in broccoli were stable under frozen storage, and
residues in all samples of all 3 crops were ≤LOQ (≤0.010 ppm). 
Therefore, despite the poor storage stability recoveries from cabbage
and mustard greens (both of which have the same use pattern as
broccoli), HED recommends that the tolerance for fluazinam in Group 5 be
set at the LOQ (0.01 ppm), based on the weight of evidence provided by
the broccoli field trials and storage stability studies.  A separate
individual tolerance was also listed for fluazinam in turnip leaves, a
future member of the leafy Brassica greens subgroup 5-B.  

	Ginseng:  Residue data inputs resulted in an MRL/tolerance calculator
recommendation of a 3.0 ppm tolerance for fluazinam on ginseng.  Because
of 65-72% recoveries from storage stability samples (corrected for
concurrent recovery), HED recommends that the tolerance be increased by
50%, to 4.5 ppm.  

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HED recommends that the tolerance in Subgroup 6-C (except peas) be
double the LOQ (0.01 ppm), or 0.02 ppm.  

	Succulent Shelled Beans (Subgroup 6-B, Except Peas):  The
representative bean commodity of subgroup 6-B is one succulent shelled
cultivar of bean which, in this case, was lima bean.  All fluazinam
residues in succulent shelled beans were <LOQ (<0.020 ppm) but, based on
fluazinam dissipation during frozen storage of roughly 50%, HED
recommends that the tolerances in Subgroup 6-B (except peas) be double
the LOQ (0.02 ppm), or 0.04 ppm.  

  SEQ CHAPTER \h \r 1 There are no established or proposed Canadian or
Codex MRLs for residues of fluazinam in plant or animal commodities. 
There are Mexican MRLs established for residues of fluazinam in potato
at 0.05 ppm, and in beans at 0.1 ppm.  The International Residue Limit
Status sheet is shown in Appendix 1.  Residue data sets for blueberries
and ginseng, utilized as inputs in the MRL/tolerance calculator, are
shown in Appendix 2.  

Table 12.	Tolerance Summary for Fluazinam.

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

[Correct Commodity Definition]

Ginseng	3.00	4.5

	Bean, dry	0.01	0.02	[Pea and bean, dried shelled, except soybean,
subgroup 6-C (except peas)]

Succulent-shelled legume vegetables subgroup 6B, except pea	0.02	0.04
[Pea and bean, succulent shelled, subgroup 6-B (except peas)]

Edible-podded legume vegetables subgroup 6A, except peas	0.15	0.10
[Vegetable, legume, edible-podded, subgroup 6-A (except peas)]

Leafy Brassica greens subgroup	0.02	0.01	Crop group tolerance is
appropriate. [Vegetable, Brassica leafy, group 5]

Head and stem Brassica subgroup	0.01

Turnip, leaves	0.02	0.01	[Turnip, tops]

Bushberry subgroup 13B	4.5	7.0	[Bushberry subgroup 13-B]

Aronia berry	4.5	7.0

	Blueberry, lowbush	4.5	Not needed.	Lowbush blueberry is already a
member of the bushberries subgroup, 13-B.

Buffalo currant	4.5	7.0

	Chilean guava	4.5	7.0

	European barberry	4.5	7.0

	Highbush cranberry	4.5	7.0

	Honeysuckle	4.5	7.0

	Jostaberry	4.5	7.0

	Juneberry	4.5	7.0

	Lingonberry	4.5	7.0

	Native currant	4.5	7.0

	Salal	4.5	7.0

	Sea Buckthorn	4.5	7.0

	



References

	Temporary Tolerance Petition and Experimental Use Permit for Use of
Fluazinam on Peanuts; 050534-EUP-E.; D177127 and D177137; George
Herndon; 6/19/1992.  

	Temporary Tolerance Petition and Experimental Use Permit for Use of
Fluazinam on Peanuts; 050534-EUP-E. Submission Dated 1/23/95 in Response
to the Memo of G.J. Herndon Dated 6/19/92.; D212612, D216941, and
D217467; George Herndon; 9/5/1995.  

	Fluazinam.  Decision by Metabolism Assessment Review Committee (MARC).;
D272624; William Cutchin; 4/23/2001.  

	PP#9F5079.  Request for the Use of Fluazinam on Peanuts, Potatoes, and
Wine Grapes.  Evaluation of Analytical Chemistry and Residue Data.;
D257115; William Cutchin; 5/21/2001.  

	PP#9F5079.  Fluazinam in/on Peanuts and Grapes.  Tolerance Method
Validation Report.; D266802; Paul Golden; 6/22/2001.  

  SEQ CHAPTER \h \r 1 Attachments 

Appendix 1 - International Residue Limits.  

Appendix 2 - Tolerance Assessment Data Sets.  



Appendix 1 - International Tolerances.

INTERNATIONAL RESIDUE LIMIT STATUS

Chemical Name: 
3-chloro-N-[3-chloro-2,6-dinitro-4-(trifluoromethyl)phenyl]-5-(trifluoro
methyl)-2-pyridinamine	Common Name:  Fluazinam	X Recommended tolerances

 Reevaluated tolerance

 Other

	Date:  6/20/2007

Codex Status (Maximum Residue Limits)	US Tolerances

X  No Codex proposal step 6 or above

  No Codex proposal step 6 or above for the crops requested	Petition
Number:  6E7139, 6E7139

DP Number:  335640

Other Identifier:  PC Code 129098

Residue definition (step 8/CXL):  NA	Reviewer/Branch:  William T.
Drew/RAB2

	Residue definition:  Fluazinam

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

Ginseng	4.5

Dried shelled pea and bean (except soybean) subgroup 6-C, except peas
0.02

Succulent shelled pea and bean subgroup 6-B, except peas	0.04

Edible-podded legume vegetables subgroup 6-A, except peas	0.10

Brassica (Cole) leafy vegetables group 5	0.01

Turnip, tops (leaves)	0.01

Bushberry subgroup 13-B	7.0

Aronia berry	7.0

Blueberry, lowbush	7.0

Buffalo currant	7.0

Chilean guava	7.0

European barberry	7.0

Highbush cranberry	7.0

Honeysuckle	7.0

Jostaberry	7.0

Juneberry	7.0

Lingonberry	7.0

Native currant	7.0

Salal	7.0

Sea Buckthorn	7.0

Limits for Canada	Limits for Mexico

X  No Limits

  No Limits for the crops requested	  No Limits

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Appendix 2 - Tolerance Assessment Data Sets.  



EPA

Fluazinam

Blueberry

23-32 Days

3.8-4.1 lb ai/A

IR-4

Residues

0.450

0.490

0.420

0.680

1.200

1.000

0.500

0.550

0.160

0.120

0.064

0.074

0.170

0.130

1.500

1.200

0.700

0.640

1.600

1.700

1.600

2.000

0.070

EPA

Fluazinam

Ginseng

29-31 Days

3.1-3.4 lb ai/A

IR-4

Residues

1.200

1.400

0.730

0.940

0.580

0.960

0.460

0.280

 PAGE   

 PAGE   1  of   NUMPAGES  30 

Fluazinam	Summary of Analytical Chemistry and Residue Data	DP #335640

 PAGE   30  of   NUMPAGES  30