Document ID: EPA-HQ-OPP-2007-1192-0007
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2009-03-04T05:00Z

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, D.C.  20460

OFFICE OF           

PREVENTION, PESTICIDES

AND TOXIC SUBSTANCES

MEMORANDUM

Date:		     8/18/08.

Subject:	Famoxadone.  Amended Section 3 Registration on Bulb Vegetables,
Crop Group 3; Leafy Greens, Subgroup 4A; Leaf Petioles, Subgroup 4B; and
Cilantro.  Summary of Analytical Chemistry and Residue Data.  PP#7E7280
& 7E7281.

PC Code:  113202	DP Num: 349184 & 349198   

MRID No.:  47280501-3 & 47280601 	Registration No.: 352-604

Petition No.: 7E7280 & 7E7281	Regulatory Action: Section 3

Assessment Type: Residue Chemistry	Reregistration Case No.: ‘None’

TXR No.: ‘None’	CAS No.: 131807-57-3

From:		W. Cutchin, Chemist

Alternative Risk Integration Assessment Team (ARIA)

Risk Integration Minor Use and Emergency Response Branch (RIMUERB)	
Registration Division (RD; 7505P)

Through:	D. Dotson, Ph. D., Chemist

Registration Action Branch 2 (RAB2)

Health Effects Division (HED; 7509P)

To:		B. Hanson, Biologist

ARIA/RIMUERB/RD (7505P)

After continuing consultations with RAB2, the original document (PP#
7E7280 & 7E7281, DP Num: 349184 & 349198, W. Cutchin, 4/18/08) has been
amended.  The document was prepared under contract by Dynamac
Corporation (1910 Sedwick Rd. Building 100, Suite B, Durham NC 27713;
submitted 1/31/2008).  The document has been reviewed and revised to
reflect current Office of Pesticide Programs (OPP) policies.

I.	 CONCLUSIONS

Regulatory Recommendations

Pending submission of a revised Section B (see requirements under
Directions for Use), the resolution of data deficiencies for confined
rotational crops (see requirements under 860.1850), and the submission
of a revised Section F (see requirements under Proposed Tolerances),
there are no residue chemistry issues that would preclude granting a
conditional registration for the requested uses of famoxadone on bulb
onion, subgroup 3-07A; green onion, subgroup 3-07B; leafy vegetables,
group 4, except spinach; spinach; and cilantro.  The proposed uses and
the submitted data support the following tolerances for residues of
famoxadone per se in/on the following crop group/subgroups:

Onion, bulb, subgroup 3-07A	0.45 ppm

Onion, green, subgroup 3-07B	40.0 ppm

Leafy vegetables (except Brassica), group 4, except spinach	25.0 ppm

Spinach	50.0 ppm

Cilantro, leaves	25.0 ppm

  SEQ CHAPTER \h \r 1 Residue Chemistry Deficiencies

860.1200 Directions for Use

The rotational crop restriction listed on the product label for Tanos®
Fungicide should be revised to specify the following: “Crops listed on
the famoxadone label may be planted back at any time; cereal grains may
be planted back following a minimum plant back interval of 30 days; and
all other crops may be planted back following a minimum plant back
interval of one year.”

860.1850  Confined Rotational Crops

As requested in PP#0F06070 (DP#s 287253 and 271377, M. Doherty,
4/18/03), a new confined rotational crop study reflecting 1x the maximum
registered seasonal rate is required.  Alternatively, the reviewed study
(MRID 44946411) may be upgraded to acceptable status pending
characterization and identification of radioactive residues.  Pending
the new confined rotational study or upgrade of the existing study, the
rotational crop restrictions noted in 860.1200 Directions for Use are
required. 

860.1550  Proposed Tolerances

A summary of the recommended tolerances along with recommendations for
commodity definitions are presented in Table 9.  The petitioner is
required to submit a revised Section F to reflect the recommendations in
Table 9.

A human health risk assessment will be prepared as a separate document.

II.	ACTION REQUESTED

The   SEQ CHAPTER \h \r 1 Interregional Research Project No. 4 (IR-4),
on behalf of the State Agricultural Experiment Stations of CA, CO, DE,
FL, ID, NJ, NY, OK, and TX, requests the establishment of permanent
tolerances for residues of the fungicide famoxadone,
[3-anilo-5-methyl-5-(4-phenoxyphenyl)-1,3-oxazolidine-2,4-dione], in/on
the raw agricultural commodities and crop groups/subgroups listed below.

Leafy greens, subgroup 4A	50 ppm

Leaf, petioles, subgroup 4B	25 ppm

Cilantro, leaves	50 ppm

Vegetable, bulb, group 3	40 ppm

Chive, fresh leaves	40 ppm

Chive, Chinese, fresh leaves	40 ppm

Daylily, bulb	40 ppm

Elegans hosta	40 ppm

Fritillaria, bulb	40 ppm

Fritillaria, leaves	40 ppm

Garlic, Serpent, bulb	40 ppm

Kurrat	40 ppm

Lady’s leek	40 ppm

Leek, wild	40 ppm

Lily, bulb	40 ppm

Onion, Beltsville bunching	40 ppm

Onion, Chinese, bulb	40 ppm

Onion, fresh	40 ppm

Onion, macrostem	40 ppm

Onion, pearl	40 ppm

Onion, potato, bulb	40 ppm

Onion, tree, tops	40 ppm

Shallot, bulb	40 ppm

Shallot, fresh Leaves	40 ppm

Section F of the petition concurrently requests the removal of the
established famoxadone tolerance for:

Lettuce, head	10.0 ppm

IR-4’s submission of supporting field trial data for celery, spinach,
onions, and lettuce (leaf) contain residue data for both active
ingredients, cymoxanil and famoxadone, included in the end-use product
(EP).  This summary document addresses only the residue chemistry data
for famoxadone; the residue chemistry data for cymoxanil will be
addressed in a separate summary document.

III.	EXECUTIVE SUMMARY

Famoxadone is an oxazolidinedione fungicide.  It inhibits oxidative
phosphorylation in the fungal mitochondria and is highly active against
spore germination and mycelial growth.  Famoxadone is presently
registered in the United States for food/feed uses on   SEQ CHAPTER \h
\r 1 fruiting vegetables, crop group 8; cucurbit vegetables, crop group
9; caneberrries, subgroup 13A; grapes (regional registration); potatoes;
and head lettuce.

Tolerances for residues of famoxadone are listed in 40 CFR §180.587 and
are expressed in terms of famoxadone per se.  Famoxadone tolerances
in/on plant commodities have been established on: caneberry, subgroup
13A at 10 ppm; grape raisin at 4.0 ppm; hop, dried cone at 80 ppm;
lettuce, head at 10.0 ppm; potato at 0.02 ppm; tomato at 1.0 ppm;
vegetable, cucurbits, group 9 at 0.30 ppm; vegetable, fruiting, group 8
except tomato at 4.0 ppm; and grape as a tolerance with a regional
registration at 2.5 ppm.  Famoxadone tolerances in/on animal commodities
have been established in milk fat at 0.06 ppm, and the fat at 0.02 ppm
and liver at 0.05 ppm of cattle, goat, horse, and sheep.

The EP relevant for this registration action is Tanos® Fungicide (EPA
Reg. No. 352-604), a dry flowable (DF) formulation containing 25% active
ingredient (ai) cymoxanil plus 25% ai famoxadone. The petitioner wishes
to amend the product label for Tanos® Fungicide to include new uses on
bulb vegetables, crop group 3; leafy greens, subgroup 4A; and leaf
petioles, subgroup 4B.  Tanos® Fungicide is proposed for multiple
foliar sprays using ground or aerial equipment at maximum seasonal rates
of 1.31 lb ai/A for bulb vegetables and spinach, and at 0.75 lb ai/A for
leafy greens (except spinach) and leaf petioles.  The proposed
preharvest intervals (PHIs) on these crops range from 1 to 3 days.  The
rotational crop restriction listed on the product label for Tanos®
Fungicide should be revised to specify the following: “Crops listed on
the famoxadone label may be planted back at any time; cereal grains may
be planted back following a minimum plant back interval of 30 days; and
all other crops may be planted back following a minimum plant back
interval of one year.” 

The nature of the residue in primary crops is adequately understood
based on acceptable metabolism studies conducted on grapes, potatoes,
and tomatoes.  The metabolic profiles in the tested primary crops were
similar in that the majority (90+ % total radioactive residues) of the
residue consisted of surface residues of famoxadone.  However, the
pathways and metabolites in each crop differed slightly.  HED has
determined that residue of concern in plant commodities, for the
purposes of risk assessments and tolerance expression, is famoxadone per
se based on crops which are currently registered.  However,   SEQ
CHAPTER \h \r 1 HED believes that a metabolism study with an oilseed or
grain crop is needed in the future to complete a general understanding
of the nature of the residue in all target crops.

The nature of the residue in rotational crops is inadequately
understood.  A confined rotational crop study has been previously
submitted but was deemed incomplete because of inadequate
characterization of radioactive residues.  HED has determined that there
is not enough evidence to exclude residues of parent and the metabolites
IN-MQ613, IN-KZ534 or IN-KZ007 from the risk assessment due to the
experimental design of the confined rotational crop study.  Once the
nature of the residue in rotational crops is understood, the residues of
concern for the tolerance expression will be determined, and the
residues for risk assessment may be redefined.

  SEQ CHAPTER \h \r 1 Based on the data from the confined study
indicating that famoxadone is the principal residue in rotated wheat
matrices at 30 days, the overall low level of residues in the confined
rotational crop study, and on the lack of famoxadone residues in the
submitted limited field rotational study, HED had previously recommended
that the label for formulations containing famoxadone be modified to
indicate that crops listed on the famoxadone label may be planted back
at any time; cereal grains may be planted back following a minimum plant
back interval (PBI) of 30 days; and all other crops may be planted back
following a minimum PBI of one year.

There are no livestock feedstuffs associated with the proposed uses on
the crops addressed herein. Therefore, data requirements for animal
metabolism, residue analytical methods for animal commodities, storage
stability data for animal commodities, and animal feeding studies are
not relevant to this tolerance petition.

There is an adequate enforcement method, high pressure liquid
chromatography with ultra-violet detector (HPLC/UV; Method AMR 3705-95,
Revision No. 2), for determination of famoxadone residues in/on plant
commodities.    SEQ CHAPTER \h \r 1 This analytical method has undergone
a successful independent laboratory validation (ILV).  The method is
also used to quantify residues of cymoxanil and, as such, has already
undergone agency validation.    SEQ CHAPTER \h \r 1 The limit of
quantitation (LOQ) was reported to be 0.02 ppm for grapes, tomatoes,
barley and wheat grain, and 0.05 ppm for barley/wheat straw and green
forage.  Also, Protocol D from the FDA Multiresidue Methods recovers
famoxadone from wine, grapes, and tomatoes.  At this time, the
analytical method does not address all of the residues of concern in
rotational crops.

The data-collection methods used in the field trials were adequately
validated.  Onion samples were analyzed for famoxadone using a method
adapted from the liquid chromatography with mass spectroscopy detection
method, DuPont Method 9822, entitled “Magnitude of Residues of
Cymoxanil and Famoxadone in Tomatoes Following Application of DPX-KP481
50WG Fungicide at Maximum Label Rates-USA-2002.”  Spinach, celery, and
head lettuce samples were analyzed for famoxadone using modified
versions of DuPont method 13753, “Analytical Method for the
Determination of Famoxadone in Spinach (Leafy Vegetables) Using
LC/MS.”

There are adequate storage stability data to support the integrity of
samples collected from field studies.  Concurrent storage stability
studies show that residues of famoxadone are reasonably stable under
frozen storage conditions for up to 9 months in/on celery, 26 months
in/on spinach, 27 months in/on green onion, 29 months in/on dry bulb
onion, and 15 months in/on leaf lettuce.  There are no storage stability
issues or corrections that need to be applied to the various magnitude
of the residue studies.

The submitted residue data for green onion and dry bulb onion were
conducted according to the proposed use rate and PHI.  The maximum
residues of famoxadone were 0.23 ppm for dry bulb onion and 16.0 ppm for
green onion.  The onion field trials are inadequate to establish a crop
group tolerance because of wide variability of residues (88x) among the
representative commodities.  However, the data are adequate to support
the establishment of subgroup tolerances on bulb onion, subgroup 3-07A,
and green onion, subgroup 3-07B.  A revised Section F is required for
tolerances of 0.45 ppm on onion, bulb, subgroup 3-07A, and 40.0 ppm on
onion, green, subgroup 3-07B.  Since the onion, bulb, subgroup 3-07A and
onion, green, subgroup 3-07B includes them, the requested tolerances on
daylily, bulb; garlic, serpent, bulb; lily, bulb; Chinese, bulb; onion,
pearl; onion, potato, bulb; shallot, bulb; chive, fresh leaves; chive,
Chinese, fresh leaves; elegans hosta; fritillaria, leaves; kurrat;
lady's leek; leek, wild; onion, Beltsville bunching; onion, fresh;
onion, macrostem; onion, tree, tops; and shallot, fresh leaves; should
be removed from the proposed Section F.

The representative crops for leafy vegetables (except Brassica) crop
group 4 are leaf and head lettuce, spinach, and celery.  A famoxadone
tolerance of 10 ppm has been established previously for head lettuce. 
The submitted residue data for leaf lettuce, spinach, and celery are
adequate to fulfill the residue field trial data requirements for those
crops.  The recommended individual tolerances are 30.0 ppm on leaf
lettuce, 50.0 ppm on spinach, and 25.0 ppm on celery.  The seasonal
application rate for spinach is nearly 2x the proposed seasonal
application rate for the remainder of the crop group, and the residue
field trial data for spinach are higher than the data for the other
representative commodities.  The recommended spinach tolerance is 5x as
high as the existing head lettuce tolerance.  For these reasons, ARIA
recommends that the tolerance for spinach be established separately from
the leafy vegetables (except Brassica) crop group.  A revised Section F
for spinach at 50.0 ppm is required.

The remaining residue field trial data on the representative crops for
leafy vegetables (except Brassica) crop group 4 are adequate to support
a crop group tolerance for residues of famoxadone at 30.0 ppm.  However,
in order to harmonize with Canada, ARIA recommends for a tolerance at
25.0 ppm.  A revised Section F for leafy vegetable (except Brassica),
group 4, except spinach at 25.0 ppm is required.

No data have been submitted for the residues of famoxadone on cilantro. 
Cilantro is not currently a member of the leafy greens, crop subgroup
4A, except spinach.  However, since data for parsley have been
determined to be adequate to support tolerances on cilantro, and parsley
is a member of crop subgroup 4A, the data for head and leaf lettuce are
adequate to support a tolerance of 25.0 ppm on cilantro.

As there are no regulated processed commodities associated with celery,
spinach, onion, or lettuce, no processing studies are required for this
petition.

IV.	BACKGROUND

Famoxadone is one of the technical active ingredients included in
Tanos® Fungicide, a DF formulation containing 25% ai famoxadone + 25%
ai cymoxanil.  The nomenclature and physicochemical properties of
famoxadone are presented below in Tables 1 and 2, respectively.

Table 1.   Famoxadone Nomenclature.

Chemical structure	

Common name	Famoxadone

Company experimental name	DPX-JE874

IUPAC name
3-anilino-5-methyl-5-(4-phenoxyphenyl)-1,3-oxazolidine-2,4-dione

CAS name	5-methyl-5-(4
phenoxyphenyl)-3-(phenylamino)-2,4-oxazolidinedione

CAS registry number	131807-57-3

End-use product (EP)	Tanos® Fungicide (EPA Reg. No. 352-604), a DF
formulation which contains 25% ai famoxadone and 25% ai cymoxanil.

Table 2.   Physicochemical Properties of Famoxadone.

Parameter	Value	Reference

Melting point/range	  SEQ CHAPTER \h \r 1 140.3- 141.8°C	DP#s 271377
and 287253, 4/18/03, M. Doherty

PH	  SEQ CHAPTER \h \r 1 6.56 at 20°C

	Density	  SEQ CHAPTER \h \r 1 D204 = 1.310 g/mL

	Water solubility	  SEQ CHAPTER \h \r 1 pH		g/L

unbuffered	  52

2		143

3		191

5		243

7		111

9		  38

	Solvent solubility	  SEQ CHAPTER \h \r 1 Solvent		g/L

acetone		274

acetonitrile	125

dichloromethane	239

ethyl acetate	125

hexane		    0.0476

methanol		  10.0

1-octanol		    1.87

Toluene		  13.3

	Vapor pressure	  SEQ CHAPTER \h \r 1 6.4×10-4  mPa (4.8×10-9 mm Hg)

	Dissociation constant, pKa	  SEQ CHAPTER \h \r 1 Expected to be weakly
basic.  The dissociation constant could not be measured or inferred from
solubility or octanol water partition coefficient.

	Octanol/water partition coefficient, Log(KOW)	  SEQ CHAPTER \h \r 1 pH
Log Kow ± SD

3.0	4.59 ± 0.06

5.0	4.80 ± 0.13

7.0	4.65 ± 0.40

9.0	5.55 ± 0.26

	UV/visible absorption spectrum	Not available

	

V.	RESULTS/DISCUSSION

860.1200  Directions for Use

A summary of the proposed crop use directions is presented in Table 3. 
The information in Table 3 was obtained from an undated draft specimen
label for Tanos® Fungicide (EPA Reg. No. 352-604), a DF formulation
containing 25% ai cymoxanil and 25% ai famoxadone.

Table 3.  Summary of Proposed Directions for Use of Famoxadone.

Applic. Timing, Type, and Equip.	Formulation

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

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

(lb ai/A)	PHI

(days)

Bulb Vegetables, Group 3

(Including Chive, fresh leaves; Chive, Chinese, fresh leaves; Daylily,
bulb; Elegans hosta; Fritillaria, bulb; Fritillaria, leaves; Garlic,
bulb; Garlic, great-headed bulb; Garlic, serpent, bulb; Kurrat; Lady’s
leek; Leek, wild; Lily, bulb; Onion, Beltsville bunching; Onion, bulb;
Onion, Chinese, bulb; Onion, fresh; Onion, green; Onion, macrostem;
Onion, pearl; Onion, potato, bulb; Onion, tree, tops; Onion, Welsh;
Shallot, bulb; and Shallot, fresh leaves)

Foliar spray

Ground (20 GPA), Aerial (min 5 GPA), or Chemigation	Tanos®

[352-604]	0.16	Not specified	1.31	3

	Use Directions and Limitations:  Begin applications prior to the onset
of disease development.  Make preventive applications on a 5- to 7-day
schedule.  Tanos® Fungicide must be tank-mixed with a contact fungicide
which has a different mode of action (e.g., Manex copper, Kocide®,
chlorothalonil, etc.) appropriate for the targeted disease.  Do not
alternate or tank mix with other Group 11 fungicides (all strobilurins
or fenamidone) or with fungicides to which resistance has developed.  In
a cropping season, no more than 50% of the total applications should
contain Tanos® Fungicide or other Group 11 fungicides.

Leafy Greens, Subgroup 4A

(Including:  Amaranth (Chinese spinach); Arugula (roquette); Chervil;
Chrysanthemum, edible-leaved; Chrysanthemum, garland; Cilantro, fresh
leaves; Corn salad; Cress, garden; Cress, upland; Dandelion; Dock
(sorrel); Endive (escarole); Lettuce, head; Lettuce, leaf; Orach;
Parsley; Purslane, garden; Purslane, winter; Radicchio (red chicory);
Spinach; Spinach, New Zealand; and Spinach, vine)

Leaf Petioles, Subgroup 4B

(Including Cardoon; celery; celery, Chinese; celtuce; fennel, Florence;
rhubarb; Swiss chard)

Foliar spray

Ground (20 GPA), 

Aerial (5 GPA), or Chemigation	Tanos®

[352-604]	0.16	Not specified	0.75 (for all crops except spinach) 

1.31 (spinach)	1

	Use Directions and Limitations:  Begin applications prior to the onset
of disease development.  Make preventive applications on a 5- to 7-day
schedule.  Tanos® Fungicide must be tank-mixed with a contact fungicide
which has a different mode of action (e.g., copper, Kocide®, mancozeb,
manzate®, chlorothalonil, etc.) appropriate for the targeted disease. 
In a cropping season, no more than 50% of the total applications should
contain Tanos® Fungicide or other Group 11 fungicides.  Do not make
more than one application before alternating with a fungicide that has
different mode of action.  

The draft label for Tanos® Fungicide specifies the following rotational
crop restrictions: “Crops listed on the label [bulb vegetables,
caneberrries, cucurbits, grapes (east of the Rocky Mountains), hops,
leafy vegetables, peppers, potatoes, and tomatoes] may be planted back
at any time, and all other crops may be planted back following a minimum
plant back interval of 30 days.”

Conclusions:  The proposed uses of Tanos® Fungicide on bulb vegetables,
crop group 3, leafy greens, subgroup 4A, and leaf petioles, subgroup 4B
are adequate to allow evaluation of the submitted residue data. 
However, the label should be revised to specify the following rotational
crop restrictions:  “Crops listed on the famoxadone label may be
planted back at any time; cereal grains may be planted back following a
minimum plant back interval of 30 days; and all other crops may be
planted back following a minimum plant back interval of one year.”

860.1300 Nature of the Residue - Plants

DP# 288134, M. Doherty, 3/12/03

DP#s 287253 and 271377, M. Doherty, 4/18/03

The available plant metabolism studies with famoxadone on tomatoes,
grapes, and potatoes have been deemed scientifically acceptable and
adequate to delineate the nature of famoxadone-related residues in crops
petitioned under PP#0F06070.  HED determined that for the petitioned
crops, the residue of concern for both tolerance enforcement and risk
assessment is famoxadone, per se. Although all the studies show
famoxadone to be the predominant residue in examined crops, there are
slight differences in the metabolic profile for each.  In order for the
Agency to conclude that the metabolism of famoxadone is adequately
delineated in all crops, a metabolism study in an oilseed or grain crop
will need to be submitted in the future.

860.1300 Nature of the Residue - Livestock

There are no livestock feedstuffs associated with the proposed uses on
celery, spinach, onion, and leaf lettuce.  Therefore, data requirements
for livestock metabolism are not relevant to this tolerance petition.

860.1340 Residue Analytical Methods

Enforcement methods

DP# 261144, S. Levy. 11/21/02

DP#s 287253 and 271377, M. Doherty, 4/18/03

 0.999) within the range of 0.01-3.0 μg/mL.  Percent recoveries were
within guideline levels of 70-120% with acceptable standard deviations
(±20%).

Extraction efficiency of incorporated 14C-labelled famoxadone was
evaluated in plant matrices.  The extraction efficiency of the residue
extraction method as compared to the metabolism extraction methodology
was adequate for famoxadone in all matrices evaluated.

Data-collection methods

Onion samples were analyzed for famoxadone using a method adapted from
the DuPont Method 9822 entitled “Magnitude of Residues of Cymoxanil
and Famoxadone in Tomatoes Following Application of DPX-KP481 50WG
Fungicide at Maximum Label Rates-USA-2002”.  Spinach, celery, and head
lettuce samples were analyzed for famoxadone using modified versions of
DuPont method 13753 “Analytical Method for the Determination of
Famoxadone in Spinach (Leafy Vegetables) Using LC/MS”.

For the modified Method 9822, residues were extracted with ACN:water,
partitioned into the ACN layer with NaCl, and cleaned up by SPE.  Then
the extracts were concentrated, partitioned with hexane, cleaned up
using Florisil column chromatography and analyzed using LC/MS/MS.  The
statistically calculated LOQ for famoxadone was 0.03 ppm for green onion
and 0.05 ppm for dry bulb onion.  The limit of detection (LOD) was 0.01
ppm for green onion and 0.02 ppm for dry bulb onion.  The lower limit of
method validation (LLMV) for famoxadone was 0.05 ppm.

For the modified Method 13752, samples were extracted with ACN:water,
partitioned into the ACN phase with NaCl, and cleaned up using SPE. 
Then the extracts were concentrated under nitrogen stream, partitioned
with hexane, and cleaned up using SPE.  The cleaned extract was
concentrated under nitrogen stream, reconstituted with methanol and
0.02% aqueous formic acid, and analyzed using LC/MS/MS.  The
statistically calculated LOQ for celery was 0.03 ppm, and the LOD was
0.01 ppm.  For spinach, the LOQ was 0.0004 ppm, and the LOD was 0.0001
ppm.  For lettuce, the LOQ for famoxadone was 0.013 ppm, and the LOD was
0.005 ppm.

In each field trial, the method was adequately validated with control
samples of the representative commodity fortified with famoxadone at
0.05-25 ppm.

860.1360 Multiresidue Methods

DP#s 287253 and 271377, M. Doherty, 4/18/03

Famoxadone has been evaluated under the EPA’s multiresidue method
testing.  Preliminary analysis suggests that Protocol D may be
appropriate for analysis of famoxadone in plant matrices and has the
potential to be the primary enforcement method.

860.1380 Storage Stability

Samples collected from the field studies were stored frozen prior to
residue analysis.  The storage durations and conditions of samples are
presented in Table 5.

Table 5.   Storage Conditions and Intervals of Samples from Field Trial
Studies.

Matrix 	Storage Temperature (°C)	Actual Storage Duration

(Days)	Interval of Demonstrated Storage Stability 1 (Days)

Celery, Stalks and Leaves	-21 ± 7	57-169	277

Spinach	≤-12	703 (808)	765

Green Onion	≤-15	795	796

Dry Bulb Onion	≤-15	916	873

Leaf Lettuce	-21 ± 7	83-342	442

1  Based on concurrent frozen stability studies conducted with the field
trials.

Conclusions:  There are adequate storage stability data to support the
integrity of samples collected from field studies.  Residues of
famoxadone are stable under frozen storage conditions for up to 9 months
in/on celery, 26 months in/on spinach, 27 months in/on green onion, 29
months in/on dry bulb onion and 15 months in/on leaf lettuce.  There are
no storage stability issues or corrections that need to be applied to
the various residue studies.

860.1400 Water, Fish, and Irrigated Crops

There are no proposed/registered uses that are relevant to this
guideline.

860.1460 Food Handling

There are no proposed/registered uses that are relevant to this
guideline.

860.1480 Meat, Milk, Poultry, and Eggs

There are no livestock feedstuffs associated with the proposed uses on
celery, spinach, onion, and leaf lettuce.  Therefore, data requirements
pertaining to meat, milk, poultry, and eggs are not relevant to this
tolerance petition.

860.1500 Crop Field Trials

The IR-4 has submitted magnitude of the residue studies for onion, leaf
lettuce, spinach, and celery in support of proposed tolerances discussed
in this document.  These studies have been reviewed, and the Executive
Summaries of field trial DERs are reproduced below followed by a crop
conclusion.

Vegetable, Bulb (Group 3)

Onions (Green and Dry Bulb)

47280501.der (onion)

Four green onion and eight dry bulb onion field trials were conducted in
Zones 1, 2, 5, 6, 9, 10, 11, and 12 during the 2002-2004 growing
seasons.  Famoxadone was applied using Tanos® Fungicide (EPA Reg. No.
352-604) as the test formulation.  The onion plants received seven
broadcast or directed foliar treatments at single application rates of
0.184-0.198 lb ai/A, with retreatment intervals (RTIs) of 4-7 days, for
a total of 1.32-1.34 lb ai/A (except for the NY01 trial which had six
broadcast or directed foliar applications at rates of 0.182-0.745 lb
ai/A and RTIs of 6-8 days, for a total of 1.32-1.71 lb ai/A). 
Applications were made using ground equipment in volumes of 32-81 gal/A,
and did not include the use of any spray adjuvants.  Duplicate control
and treated samples of mature green and dry bulb onion were collected at
each site at 2-4 days after the last treatment (DAT).  To generate
residue decline data from two sites, samples were harvested at 1, 3,
7/8, and 14/15 days following the last application.

fortified samples were stored for 27 months (green onion) and 29 months
(dry bulb onion) under the same conditions (≤-15ºC) as the field
trial samples.  At the end of the analytical phase, the stored samples
were analyzed in triplicate along with a control sample freshly
fortified with famoxadone.  The recoveries indicate that the residues
are stable on onions for the study duration.  

Samples were analyzed for residues of famoxadone using the DuPont method
9822 entitled, “Magnitude of Residues of Cymoxanil and Famoxadone in
Tomatoes Following Application of DPX-KP481 50DF Fungicide at Maximum
Label Rates-USA-2002,” with modifications.  The statistically
calculated LOQs for famoxadone were 0.03 ppm for green onion and 0.05
ppm for dry bulb onion.  The LODs were 0.01 ppm for green onion and 0.02
ppm for dry bulb onion.  The LLMV for famoxadone was 0.05 ppm.  The
method was adequately validated prior to and in conjunction with the
analysis of field trial samples.  The results of the onion field trials
are summarized in Table 5.

Table 5.   Summary of Residue Data from Onion Field Trials with
Famoxadone.

Commodity	Total Applic. Rate (lb ai/A)	PHI (days)	Residue Levels of
Famoxadone (ppm)

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

Proposed use pattern  = Maximum seasonal rate of 1.31 lb ai/A with a
3-day PHI

Green Onion	1.32-1.34	3-4	8	1.30	16.0	15.0	4.10	6.11	5.65

Dry Bulb Onion	1.32-1.71	2-3	16	<0.05	0.23	0.22	0.05	0.07	0.06

Conclusions:  The submitted residue data for green onion and dry bulb
onion, which are the representative commodities of bulb vegetables, crop
group 3, are adequate to fulfill data requirements.  The number and
locations of crop field trials are in accordance with OPPTS Guideline
860.1500.  The trials reflect the proposed use pattern.  However, the
residue levels in the two types of onions vary by a factor of
approximately 88x, which indicate that a crop group tolerance on bulb
vegetables is inappropriate.  The residue data for green onion and dry
bulb onion were separately 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 II.  The spreadsheet recommends
tolerances of 40 ppm on green onion and 0.45 ppm on dry bulb onion. 
Since dry bulb onions and green onions are representative commodities
for onion, bulb, subgroup 3-07A and onion, green, subgroup 3-07B,
respectively, the data are adequate to support tolerances on the
subgroups.  A revised Section F is required for tolerances of 0.45 ppm
for onion, bulb, subgroup 3-07A, and 40.0 ppm for onion, green, subgroup
3-07B.

Since the onion, bulb, subgroup 3-07A includes them, the requested
tolerances on daylily, bulb; garlic, serpent, bulb; lily, bulb; Chinese,
bulb; onion, pearl; onion, potato, bulb; and shallot, bulb; should be
removed from the proposed Section F.

 

Similarly, since the onion, green, subgroup 3-07B includes them, the
requested tolerances on chive, fresh leaves; chive, Chinese, fresh
leaves; elegans hosta; fritillaria, leaves; kurrat; lady's leek; leek,
wild; onion, Beltsville bunching; onion, fresh; onion, macrostem; onion,
tree, tops; and shallot, fresh leaves; should be removed from the
proposed Section F.

Leafy vegetables (except Brassica) (Group 4)

Leaf lettuce

47280503.der (leaf  lettuce)

Seven leaf lettuce field trials were conducted in Zones 2, 3, and 10
during the 2004 growing season.  Famoxadone was applied using Tanos®
Fungicide (EPA Reg. No. 352-604) as the test formulation.  The leaf
lettuce plants received four broadcast or directed foliar treatments at
single application rates of 0.181-0.194 lb ai/A, with retreatment
intervals (RTIs) of 5-6 days, for a total of 0.750-0.765 lb ai/A. 
Applications were made using ground equipment in volumes of 24-49 gal/A,
and did not include the use of any spray adjuvants.  Control and treated
samples (unwashed and washed) of mature lettuce leaves were collected at
each site 1 and 2 days after the last application.

Samples were stored frozen for up to 342 days (11 months) prior to
extraction for analysis.  To support this storage interval, a concurrent
freezer storage stability study was conducted using control samples of
leaf lettuce fortified with famoxadone at 0.5 ppm.  The fortified
samples were stored for 15 months (439 and 442 days) under the same
conditions (-21ºC) as the field trial samples.  At the end of the
analytical phase, the stored samples were analyzed in duplicate or
triplicate along with a control sample freshly fortified with
famoxadone.  The recoveries indicate that the residues are stable on
lettuce for the study duration.  

The harvested samples were analyzed for famoxadone using the Cornell
Analytical Method entitled, “Residue Analysis of Famoxadone on Lettuce
by GC/NP Detection, Version #2.”  This method was adapted from DuPont
Method AMR 3705-95 with minor modifications.  The statistically
calculated LOQ for famoxadone in leaf lettuce was 0.013 ppm, the LOD was
0.005 ppm, and the LLMV was 0.02 ppm.  The method was adequately
validated in conjunction with the analysis of field trial samples.  The
results of the lettuce trials are summarized in Table 6.

Table 6.   Summary of Residue Data from Leaf Lettuce Field Trials with
Famoxadone.

Commodity	Total Applic. Rate (lb ai/A)	PHI (days)	Residue Levels of
Famoxadone (ppm)

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

Proposed use pattern  = Maximum seasonal rate of 0.75 lb ai/A with a
1-day PHI

Leaf Lettuce, Unwashed	0.750-0.765	1	14	0.24	22.0	21.5	7.30	8.02	6.32

2	14	<0.020	11.0	10.3	4.30	4.37	3.43

Leaf Lettuce, Washed

1	14	1.70	9.30	9.25	4.70	5.06	2.22

2	14	<0.020	8.40	7.80	3.80	3.95	2.54

Spinach

47280502.der (spinach)

Seven spinach field trials were conducted in Zones 1, 2, 6, 9 and 10
during the 2003-2004 growing seasons.  Famoxadone was applied using
Tanos® Fungicide (EPA Reg. No. 352-604) as the test formulation.  The
spinach plants received seven broadcast or directed foliar treatments at
single application rates of 0.181-0.200 lb ai/A, with retreatment
intervals of 4-6 days (except for the NY21 study with RTIs of 3-11
days), for a total of 1.30-1.37 lb ai/A.  Applications were made using
ground equipment in volumes of 21-29 gal/A, and did not include the use
of any spray adjuvants.  Duplicate control and treated samples of mature
unwashed spinach leaves were collected at each site at 1 and 2 days
after the last treatment.  Additional samples were collected at the CA
and TX field trials to generate data on washed samples.

Samples were stored frozen for up to 27 months prior to extraction for
analysis.  To support this storage interval, a concurrent freezer
storage stability study was conducted using control samples of spinach
fortified separately with famoxadone at 0.5 ppm.  The fortified samples
were stored for 26 months under the same conditions (≤-12ºC) as the
field trial samples.  At the end of the analytical phase, the stored
samples were analyzed in triplicate along with a control sample freshly
fortified with famoxadone.  The recoveries indicate that the residues
are stable on spinach for the study duration.  

Samples were analyzed for residues of famoxadone using a method
entitled, “Analytical Method for the Determination of Famoxadone and
IN-KQ960 in Spinach (Leafy Vegetables) Using LC/MS.”  This method was
adapted from the DuPont LC/MS Method 13753.  The statistically
calculated LOQ for famoxadone in spinach was 0.0004 ppm, the LOD was
0.0001 ppm, and the LLMV was 0.02 ppm.  The above method was adequately
validated prior to and in conjunction with the analysis of field trial
samples.  The results of the spinach trials are summarized in Table 7.

Table 7.   Summary of Residue Data from Spinach Field Trials with
Famoxadone.

Commodity	Total Applic. Rate (lb ai/A)	PHI (days)	Residue Level of
Famoxadone (ppm)

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

Proposed use pattern  = Maximum seasonal rate of 1.31 lb ai/A with a
1-day PHI

Spinach, Unwashed	1.30-1.37	1	14	5.84	36.5	34.8	15.3	17.1	8.73

2	14	3.14	29.4	21.6	11.9	12.5	6.11

Spinach, Washed

1	8	10.6	32.0	31.5	18.7	19.7	8.18

2	8	9.00	21.5	20.4	12.2	15.1	5.37

Celery

47280601.der (celery)

Thirteen celery field trials were conducted in Zones 3, 5, and 10 during
the 2004 growing season. Famoxadone was applied using Tanos® Fungicide
(EPA Reg. No. 352-604) as the test formulation.  The celery plants
received four broadcast or directed foliar treatments at single
application rates of 0.169-0.199 lb ai/A, with retreatment intervals of
4-7 days, for a total of 0.715-0.940 lb ai/A.  Applications were made
using ground equipment in volumes of 26-50 gal/A, and did not include
the use of any spray adjuvants.  Four control and treated samples of
unwashed/untrimmed and washed/trimmed mature celery stalks and leaves
were collected at each site 1 and 2 days after the last treatment.

Samples were stored frozen for up to 169 days (6 months) prior to
extraction for analysis.  To support this storage interval, a concurrent
freezer storage stability study was conducted using control samples of
celery fortified with famoxadone at 5.0 ppm.  The fortified samples were
stored for 9 months under the same conditions (-21ºC) as the field
trial samples.  At the end of the analytical phase, the stored samples
were analyzed in triplicate along with a control sample freshly
fortified with famoxadone.  The recoveries indicate that the residues
are stable on celery for the study duration.  

The collected samples were analyzed for residues famoxadone using the
Cornell Analytical Method entitled, “Residue Analysis of Famoxadone
(DPX-JE874) on Celery by GC/NP Detector, Version #3.”  This method was
adapted from the DuPont Method AMR 3705-95 with minor modifications. 
The statistically calculated LOQ for famoxadone in celery was 0.03 ppm,
the LOD was 0.01 ppm, and the LLMV was 0.02 ppm.  The results of the
celery trials are summarized in Table 8.

Table 8.   Summary of Residue Data from Celery Field Trials with
Famoxadone.

Commodity	Total Applic. Rate (lb ai/A)	PHI (days)	Residue Levels  (ppm)

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

Proposed use pattern  = Maximum seasonal rate of 0.75 lb ai/A with a
1-day PHI

Celery, No Wash/Trim	0.715-0.940	1	26	1.20	18.0	17.0	3.60	5.43	4.73

2	26	1.20	17.0	15.5	2.60	4.74	4.53

Celery, Wash/Trim

1	26	1.10	14.0	13.0	2.80	4.43	3.68

2	26	0.92	18.0	16.0	2.60	4.27	4.42

Conclusions:   The representative crops for leafy vegetables (except
Brassica) crop group 4 are leaf and head lettuce, spinach, and celery. 
A famoxadone tolerance of 10 ppm has been established previously for
head lettuce.

The submitted residue data for leaf lettuce, spinach, and celery are
adequate to fulfill the residue field trial data requirements for those
crops.  The number and locations of the crop field trials are in
accordance with OPPTS Guideline 860.1500 and the trials reflect the
proposed use patterns.   The submitted residue data 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 II.  The spreadsheet
recommends individual tolerances of 30.0 ppm on leaf lettuce, 50.0 ppm
on spinach, and 25.0 ppm on celery.  The seasonal application rate for
spinach is nearly 2x the proposed seasonal application rate for the
remainder of the crop group, and the residue field trial data for
spinach are higher than the data for the other representative
commodities.  The recommended spinach tolerance is 5x as high as the
existing head lettuce tolerance.  For these reasons, ARIA recommends
that the tolerance for spinach be established separately from the leafy
vegetables (except Brassica) crop group.  A revised Section F for
spinach at 50.0 ppm is required.

The remaining residue field trial data are adequate to support a crop
group tolerance for residues of famoxadone at 30.0 ppm.  However, Canada
has indicated that a tolerance of 25 ppm will be established for leaf
petioles, subgroup 4B at 25.0 ppm (email, D. MacGillivray, PMRA, Health
Canada, 5/14/08).  Since the highest residue found on any of the leafy
vegetables (except Brassica) crop group, except spinach is 22.0 ppm,
harmonization with Canada is possible.  ARIA recommends for a tolerance
at the level recommended by Canada.  A revised Section F for leafy
vegetable (except Brassica), group 4, except spinach at 25.0 ppm is
required.

The proposed tolerances for crop groups 4A and 4B should also be removed
from Section F.

Herb and Spice, Crop Group 19

Cilantro leaves

No data have been submitted for the residues of famoxadone on cilantro. 
Cilantro is not currently a member of the leafy greens, crop subgroup
4A, except spinach.  However, since data for parsley have been
determined to be adequate to support tolerances on cilantro
(Reviewer’s Guide, B. Schneider, 6/14/02), and parsley is a member of
leafy greens, crop subgroup 4A, the data for head and leaf lettuce are
adequate to support a tolerance on cilantro.  

Conclusions:  ARIA concludes that the data for the head and leaf lettuce
are adequate to support the requested tolerance of 25.0 ppm on cilantro.
 

860.1520 Processed Food and Feed

There are no processed food commodities associated with the proposed use
on leafy greens, petioles, spinach or onions.  Therefore a processing
study is not required.

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

Analytical standards for famoxadone are currently available in the
National Pesticide Standards Repository, with an expiration date of
4/24/2013.

860.1850 & 860.1900 Confined and Field Accumulation in Rotational Crops

DP# 271377, M. Doherty, 4/18/03

A confined rotational study was conducted with [14C[-phenoxypheynl
or-phenyl amino famoxadone formulated as a water dispersible granule and
applied at 0.36 lb ai/A, 0.32x the maximum proposed seasonal rate. 
Total 14C residues in soil, immature and mature lettuce, sugar beet and
wheat samples were determined by oxygen combustion and LSC.  Famoxadone,
IN-MQ613, IN-KZ534 and IN-KZ007 were identified in the secondary crops. 
The data are acceptable for wheat commodities, excluding grain; TRR in
grain was high enough to warrant identification and characterization,
but residues were not extracted, identified or characterized. 
Insufficient data are available on lettuce and sugar beet commodities at
PBIs beyond 30 days.

A field accumulation in rotational crops study was conducted on radish,
spinach and wheat.  Although the data were classified as scientifically
acceptable, the experimental design did not include the analysis of the
residues of concern for rotational crops (see 860.1850).  Prior to
analyzing for additional residues in the field rotational crop samples
the petitioner should address data gaps regarding the nature of the
residue in rotational crops.

Conclusions:  Pending the new confined rotational study or upgrade of
the existing study, the rotational crop restrictions noted in 860.1200
Directions for Use are required. 

860.1550 Proposed Tolerances

Tolerances are currently listed in 40 CFR (180.587 for residues of the
fungicide famoxadone,
[3-anilino-5-methyl-5-(4-phenoxyphenyl)-1,3-oxazolidine-2,4-dione].  HED
has determined that the residue of concern for plant commodities, for
the purposes of tolerance and risk assessments, is famoxadone per se. 
The tolerance expression proposed by the petitioner is consistent with
40 CFR §180.587 as well as HED’s determination.

Codex MRLs (CXL), expressed as famoxadone per se, have been established
for some plant commodities but not for the crops addressed herein. 
Canada is currently in the process of establishing a tolerance of 25 ppm
for crop subgroup 4B, leaf petioles.  An International Residue Limit
(IRL) form is appended to this Summary Document and follows this
section.

The Agency’s Guidance for Setting Pesticide Tolerances Based on Field
Trial Data was utilized for determining appropriate tolerance levels. 
The residue data for green onion, dry bulb onion, leaf lettuce, spinach,
and celery were entered into the tolerance spreadsheet (Appendix II).

The spreadsheet recommends individual tolerances of 40 ppm on green
onion and 0.45 ppm on dry bulb onion.  The tolerance levels recommended
on these two types of onions vary by a factor of approximately 88x. 
These data suggest that a crop group tolerance on bulb vegetables is
inappropriate because of the wide variability in field trial residues. 
The available data will, however, support subgroup tolerances of 0.45
ppm on onion, bulb, subgroup 3-07A, and 40.0 ppm on onion, green,
subgroup 3-07B.

The spreadsheet recommends individual tolerances of 30.0 ppm on leaf
lettuce, 50 ppm on spinach, and 25 ppm on celery.  The proposed seasonal
application rate for spinach is nearly 2x the proposed seasonal
application rate for the remainder of the crop group and the residue
field trial data for spinach are higher than the data for the other
representative commodities.  The recommended spinach tolerance is 5x as
high as the existing head lettuce tolerance.  For these reasons, ARIA
recommends that the tolerance for spinach be established separately from
the leafy vegetables (except Brassica) crop group.  ARIA recommends that
the tolerance for spinach be established at 50.0 ppm.

The remaining residue field trial data are adequate to support a crop
group tolerance for residues of famoxadone at 30.0 ppm.  However, Canada
has indicated that a tolerance of 25 ppm will be established for leaf
petioles, subgroup 4B at 25.0 ppm.  Since the highest residue found on
any of the leafy vegetables (except Brassica) crop group, except spinach
is 22.0 ppm, harmonization with Canada is possible.  ARIA recommends for
a tolerance for leafy vegetable (except Brassica), group 4, except
spinach at 25.0 ppm.

No data have been submitted for the residues of famoxadone on cilantro. 
Cilantro is not currently a member of the leafy greens, crop subgroup
4A, except spinach.  However, since data for parsley have been
determined to be adequate to support tolerances on cilantro, and parsley
is a member of crop subgroup 4A, the data for head and leaf lettuce are
adequate to support a tolerance on cilantro.  ARIA concludes that the
data for the head and leaf lettuce (except cucurbits) are adequate to
support a tolerance of 25.0 ppm on cilantro.

A summary of recommended tolerances for the current petition is listed
in Table 9. 

Table 9.   Tolerance Summary for Famoxadone.

Commodity	Proposed 

Tolerance (ppm)	Recommended 

Tolerance (ppm)	Comments; Correct Commodity Definition

Leafy greens, subgroup 4A	50	Not needed	The recommended tolerance for
leafy vegetables (except Brassica), group 4, except spinach will cover
expected residues resulting from the proposed use.

Leaf petioles, subgroup 4B	25	Not needed	The recommended tolerance for
leafy vegetables (except Brassica), group 4, except spinach will cover
expected residues resulting from the proposed use.

Leafy vegetables (except Brassica), group 4, except spinach	None	25.0
The data indicate that a tolerance on the group except spinach is
appropriate.

Spinach	None	50.0	The data indicate that a tolerance for spinach should
be separate from group 4.

Cilantro, leaves	50	25.0	Based on parsley as a member of crop subgroup
4A

Vegetable, bulb, group 3	40	Not needed	The available data suggest that a
tolerance for Bulb Vegetables, Crop Group 3 is inappropriate because of
the wide variability in field trial residues among the representative
commodities. 

Onion, bulb, subgroup 3-07A	-	0.45	The available data support subgroup
tolerance of 0.45 ppm for onion, bulb, subgroup 3-07A

Onion, green, subgroup 3-07B	-	40.0	The available data will support
subgroup tolerance of 40 ppm for onion, green, subgroup 3-07B.

Chive, fresh leaves	40	Not needed	The recommended tolerance for onion,
green, subgroup 3-07B will cover expected residues resulting from the
proposed use.

Chive, Chinese, fresh leaves	40	Not needed	The recommended tolerance for
onion, green, subgroup 3-07B will cover expected residues resulting from
the proposed use.

Daylily, bulb	40	Not needed	The recommended tolerance for onion, bulb,
subgroup 3-07A will cover expected residues resulting from the proposed
use.

Elegans hosta	40	Not needed	The recommended tolerance for onion, green,
subgroup 3-07B will cover expected residues resulting from the proposed
use.

Fritarillia, bulb	40	Not needed	The recommended tolerance for onion,
bulb, subgroup 3-07A will cover expected residues resulting from the
proposed use.

Fritarillia, leaves	40	Not needed	The recommended tolerance for onion,
green, subgroup 3-07B will cover expected residues resulting from the
proposed use.

Garlic, Serpent, bulb	40	Not needed	The recommended tolerance for onion,
bulb, subgroup 3-07A will cover expected residues resulting from the
proposed use.

Kurrat	40	Not needed	The recommended tolerance for onion, green,
subgroup 3-07B will cover expected residues resulting from the proposed
use.

Lady’s Leek	40	Not needed	The recommended tolerance for onion, green,
subgroup 3-07B will cover expected residues resulting from the proposed
use.

Leek, wild	40	Not needed	The recommended tolerance for onion, green,
subgroup 3-07B will cover expected residues resulting from the proposed
use.

Lily, bulb	40	Not needed	The recommended tolerance for onion, bulb,
subgroup 3-07A will cover expected residues resulting from the proposed
use.

Onion, Beltsville bunching	40	Not needed	The recommended tolerance for
onion, green, subgroup 3-07B will cover expected residues resulting from
the proposed use.

Onion, Chinese, bulb	40	Not needed	The recommended tolerance for onion,
bulb, subgroup 3-07A will cover expected residues resulting from the
proposed use.

Onion, fresh	40	Not needed	The recommended tolerance for onion, green,
subgroup 3-07B will cover expected residues resulting from the proposed
use.

Onion, macrostem	40	Not needed	The recommended tolerance for onion,
green, subgroup 3-07B will cover expected residues resulting from the
proposed use.

Onion, pearl	40	Not needed	The recommended tolerance for onion, bulb,
subgroup 3-07A will cover expected residues resulting from the proposed
use.

Onion, potato, bulb	40	Not needed	The recommended tolerance foronion,
bulb, subgroup 3-07A will cover expected residues resulting from the
proposed use.

Onion, tree, tops	40	Not needed	The recommended tolerance for onion,
green, subgroup 3-07B will cover expected residues resulting from the
proposed use.

Shallot, bulb	40	Not needed	The recommended tolerance for onion, bulb,
subgroup 3-07A will cover expected residues resulting from the proposed
use.

Shallot, fresh leaves	40	Not needed	The recommended tolerance for onion,
green, subgroup 3-07B will cover expected residues resulting from the
proposed use.

Leaf petioles, subgroup 4B	None	25.0	The recommended subgroup tolerance
is based on adequate data from celery.

References

DP#:		288134

Subject:	MARC Decision Memo

From:		M, Doherty

To:		

Dated:		3/12/03

MRID(s):	None

DP#:		287253 and 271377

Subject:	Famoxadone.  Summary of Analytical Chemistry and Residue Data. 
PP#0F06070:  Section 3 Registration on Fruiting Vegetables, Cucurbit
Vegetables, Head Lettuce, and Potatoes.  PP#7E04847:  Tolerance without
a U.S. Registration for Grapes and Raisins.

From:		M. Doherty

To:		J. Whitehurst/C. Giles Parker

Dated:		04/18/03

MRID(s):	44302446, 44302448, 44302451-44302453, 44302458-44302464,
44946411, 44946412, 44946415-44946425, 44946427-44946431, 44331201,
44579102, 45620301, 44967205, 45845601

DP#:		None

Subject:	Minutes of the 4/7/04 ChemSAC Meeting

From:		HED’s Chemistry Science Advisory Council

To:		HED’s Chemistry Interest Group

Dated:		4/19/04

MRID(s):	None

  SEQ CHAPTER \h \r 1 Attachments:

International Residue Limit Status sheet

Appendix I - Tolerance Assessment Calculations

APPENDIX I – INTERNATIONAL RESIDUE LIMIT STATUS

INTERNATIONAL RESIDUE LIMIT STATUS

Chemical Name: 
3-anilino-5-methyl-5-(4-phenoxyphenyl)-1,3-oxazolidine-2,4-dione	Common
Name:

Famoxadone	X Proposed tolerance

 Reevaluated tolerance

 Other	Date:  1/31/2008

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:  7E7280

DP#:   349184

Other Identifier:  

Residue definition (step 8/CXL):  famoxadone	Reviewer/Branch:  W.
Cutchin/ARIA

	Residue definition:  famoxadone
(3-anilino-5-methyl-5-(4-phenoxyphenyl)-1,3-oxazolidine-2,4-dione)  SEQ
CHAPTER \h \r 1 

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

Grape pomace, Dry	7	Leafy greens, subgroup 4A	50

Grapes	2	Cilantro, leaves	50

Vegetable, bulb, group 3	40

Chive, fresh leaves	40

Chive, Chinese, fresh leaves	40

Daylily, bulb	40

Elegans hosta	40

Fritarillia, bulb	40

Fritarillia, leaves	40

Garlic, Serpent, bulb	40

Kurrat	40

Lady’s Leek	40

Leek, wild	40

Lily, bulb	40

Onion, Beltsville bunching	40

Onion, Chinese, bulb	40

Onion, fresh	40

Onion, macrostem	40

Onion, pearl	40

Onion, potato, bulb	40

Onion, tree, tops	40

桓污潬ⱴ戠汵ݢ〴܇܇桓污潬ⱴ映敲桳氠慥敶ݳ〴܇楌業
獴映牯䌠湡摡ݡ楌業獴映牯䴠硥捩ݯ堇†丠⁯楌業獴

   No Limits for the crops requested	X   No Limits

   No Limits for the crops requested

Residue definition  N/A	Residue definition:  N/A

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

Notes/Special Instructions:  S. Funk, 06/20/2006.

Appendix II.  Tolerance Assessment Calculations.

For each of the crops listed below, the Guidance for Setting Pesticide
Tolerances Based on Field Trial Data (SOP), along with the tolerance
spreadsheet, was used for calculating recommended tolerances.  As
specified in the SOP, the minimum of the 95% upper confidence limit
(UCL) on the 95th percentile and the point estimate of the 99th
percentile was selected as the tolerance value in cases when the dataset
was large (greater than 15 samples) and reasonably lognormal.  For
datasets that were small (≤15 samples) and reasonably lognormal, the
upper bound estimate of the 95th percentile based on the median residue
value was compared to the minimum of the 95% UCL on the 95th percentile
and the point estimate of the 99th percentile, and the minimum value was
selected as the tolerance value.  For datasets that were not lognormal,
the upper bound on the 89th percentile was selected as the tolerance
value (distribution-free method).  The rounding procedures specified in
the SOP were also used.

Leaf Petioles, Subgroup 4B

The dataset used to establish a tolerance for famoxadone on leaf
petiole, subgroup 4B consisted of field trial data for celery (the
representative crops of the leaf petiole, subgroup 4B), representing
application rates of 0.715-0.940 lb ai/A (four applications at
0.169-0.199 lb ai/A/application) with a 1-day PHI.  As specified by the
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
II-1.

All field trial sample results for celery were above the LOQ (0.03 ppm).
 The celery dataset was not small (26 samples).  Visual inspection of
the lognormal probability plot for celery (Figure I-1) provided in the
spreadsheet indicated that the celery dataset was reasonably lognormal. 
The results from the approximate Shapiro-Francia test statistic (Figure
I-2) confirmed that the assumption of lognormality should not be
rejected for celery.

Using the tolerance spreadsheet, the recommended tolerance is 25 ppm for
celery.  As the representative commodity of the leaf petioles, subgroup,
the recommended tolerance for celery may be used to support a tolerance
of 25 ppm for leaf petioles, subgroup 4B.

Leafy Greens, Subgroup 4A

The dataset used to establish a tolerance for famoxadone on leafy greens
subgroup 4A consisted of field trial data for leaf lettuce, spinach, and
a previously established tolerance for head lettuce (the representative
crops of leafy greens subgroup 4A), representing application rates of
0.75 lb ai/A (spinach) or 1.3 lb ai/A for leaf and head lettuce (7 and 4
applications, respectively at 0.181-0.200 lb ai/A/application) with a
1-day PHI.  As specified by the 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 II-2.

All field trial sample results for leaf lettuce and spinach were above
the LOQ (0.0004 ppm for spinach and 0.013 ppm for lettuce).  The leaf
lettuce and spinach datasets were not small (14 samples each).  Visual
inspection of the lognormal probability plots for lettuce and spinach
(Figures I-3 and I-5, respectively) provided in the spreadsheet
indicated that the spinach dataset was reasonably lognormal, but that
leaf lettuce dataset was not.  The results from the approximate
Shapiro-Francia test statistic (Figures I-4 and I-6) confirmed that the
assumption of lognormality should not be rejected for spinach but should
be rejected for leaf lettuce.

Using the tolerance spreadsheet, the recommended tolerances are 30 ppm
for leaf lettuce and 50 ppm for spinach.  The previously determined
tolerance for head lettuce is 10.0 ppm.  Because the minimum and maximum
recommended tolerances differ by exactly 5x, a crop group tolerance is
appropriate for leafy greens, subgroup 4A.  The recommended value is 50
ppm, the maximum of the recommended individual tolerances.

Bulb Vegetable, Group 3

The dataset used to determine whether a tolerance for famoxadone on bulb
vegetable (group 3) is appropriate consisted of field trial data from
green onion and dry bulb onion (the representative crops of bulb
vegetable crop group 3), representing application rates of 1.32-1.71 lb
ai/A (7 applications at 0.184-0.198  lb ai/A/application, with the
exception of one trial which had 6 applications at 0.182-0.745 lb ai/A
for a total of 1.71 lb ai/A) with a 2-4-day PHI.  As specified by the
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
II-3.

All field trial sample results for green onions were above the LOQ (0.03
ppm).  Because 11 of 16 field trial sample results for dry bulb onions
were below LOQ, maximum likelihood estimation (MLE) procedures were
needed to impute censored values.  The green onion dataset was small (8
samples).  The bulb onion dataset was not small (16 samples).  The
dataset for each crop was entered into the tolerance spreadsheet. 
Visual inspection of the lognormal probability plots for green onion and
dry bulb onion (Figures II-7 and II-9, respectively) provided in the
spreadsheet indicated that the bulb onion dataset was reasonably
lognormal, but that the green onion dataset was not.  The results from
the approximate Shapiro-Francia test statistic (Figures II-8 and II-10)
confirmed that the assumption of lognormality should not be rejected for
bulb onions but should be rejected for green onions.  

Using the tolerance spreadsheet, the recommended tolerances are 40 ppm
for green onions and 0.45 ppm for bulb onion.  Because the minimum and
maximum recommended tolerances differ by more than 5x, a crop group
tolerance is not appropriate for bulb, vegetable, group 3.  



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Figure II   SEQ Figure_II \* ARABIC  1 :  Lognormal probability plot of
Famoxadone field trial data for Celery.

Figure II   SEQ Figure_II \* ARABIC  2 : Tolerance spreadsheet summary
of Famoxadone field trial data for Celery.

Table II-2.   Residue Data Used to Calculate Tolerance for Famoxadone on
Leafy Greens, Subgroup 4A.

Regulator:	EPA	EPA

Chemical:	Famoxadone	Famoxadone

Crop:	Leaf Lettuce (unwashed)	Spinach (unwashed)

PHI:	1 day	1 day

App. Rate:	0.750-0.765 lb ai/A	1.30-1.37 lb ai/A

Submitter:	IR-4	IR-4

MRID Citation:	MRID TBD	MRID TBD 

	Residues	Residues

	6.90	15.20

	7.40	20.50

	7.40	36.50

	7.20	33.00

	8.40	10.10

	6.80	17.40

	0.42	15.30

	0.24	11.90

	3.60	5.84

	4.50	8.30

	8.80	13.80

	7.60	11.40

	21.00	20.20

	22.00	20.20

Figure II   SEQ Figure_II \* ARABIC  3 : Lognormal Probability plot of
famoxadone field trial data for leaf lettuce.

Figure II   SEQ Figure_II \* ARABIC  4 :  Tolerance spread sheet summary
of famoxadone field trial data for leaf lettuce

Figure II   SEQ Figure_II \* ARABIC  5 :Lognormal probability plot of
famoxadone field trial data for spinach.

Figure II   SEQ Figure_II \* ARABIC  6 :  Tolerance spreadsheet summary
of famoxadone field trial data for spinach.

Table II-3.   Residue Data Used to Calculate Tolerance for Famoxadone on
Bulb, Vegetable, Group 3

Regulator:	EPA	EPA

Chemical:	Famoxadone	Famoxadone

Crop:	Green Onion	Dry bulb Onion (MLE)

PHI:	3-4 day	2-3 day

App. Rate:	1.32-1.34 lb ai/A	1.32-1.71 lb ai/A

Submitter:	IR-4	IR-4

MRID Citation:	MRID TBD 	MRID TBD 

	Residues	Residues

	1.40	0.004

	1.30	0.007

	16.00	0.009

	14.00	0.012

	4.10	0.015

	3.40	0.018

	4.60	0.021

	4.10	0.025

0.030

0.035

0.042

0.060

0.077

0.079

0.200

0.230

Figure II   SEQ Figure_II \* ARABIC  7 :  Lognormal probability plot of
famoxadone field trial data for green onion.

Figure II   SEQ Figure_II \* ARABIC  8 : Tolerance spreadsheet summary
of famoxadone field trial data for green onion.

Figure II   SEQ Figure_II \* ARABIC  9 : Lognormal probability plot of
famoxadone field trial data for dry bulb onion (MLE)

Figure II   SEQ Figure_II \* ARABIC  10 : Tolerance spreadsheet summary
of famoxadone field trial data for dry bulb onion (MLE)

Famoxadone	Summary of Analytical Chemistry and Residue Data	DP#:  349184
& 349198

	Pg   PAGE  16  of   NUMPAGES  32