Document ID: EPA-HQ-OPP-2007-0940-0006
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2008-09-10T04:00Z

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, D.C.  20460

OFFICE OF           

PREVENTION, PESTICIDES

AND TOXIC SUBSTANCES

MEMORANDUM

Date:		5/20/08

Subject:	Fludioxonil.  Section 3 Requests for the Uses on Avocado,
Carrot, Cucurbit, Lemon, Parsley, Radish, Sweet Potato, Tomato, and
Brassica Vegetables.  Summary of Analytical Chemistry and Residue Data. 

PC Code:  071503	DP Barcode:  345970 & 349725

Decision No.:  380887	Registration No.:  100-953 & 100-969

Petition No.:  7E7234 & 2E6462	Regulatory Action:  Section 3
Registration

Risk Assessment Type:  Single Chemical	Case No.:  NA

TXR No.:  NA	CAS No.:  137-26-8

MRID No.:  47161101-06, 47161108 & 47169310-11	40 CFR:  §180.516

From:		W. Cutchin, Chemist

Alternative Risk Integration Assessment Team (ARIA)

Risk Integration Minor Use and Emergency Response Branch (RIMUERB)

Registration Division (RD; 7505P)

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

		Registration Action Branch 1 (RAB 1)

		Health Effects Division (HED; 7509P)

To:			B. Hanson, Biologist

ARIA/RIMUERB/RD (7505P)

			And

S. Jackson 

ARIA/RIMUERB/RD (7505P)

I.	 CONCLUSIONS

Regulatory Recommendations 

Provided that revised Sections B and F are received, a livestock feeding
study, and pending the results of the forthcoming human health risk
assessment, ARIA recommends for the tolerances listed in Table 7, below.

Residue Chemistry Deficiencies

Section B on root and tuber vegetables, except sugar beets should be
renamed root and tuber vegetables except sugar beets and radish as the
radish requested use is not supported by appropriate residue field trial
data.  Section B should also be revised to indicate that the use on
radish should be 2 applications at 0.22 lb ai/A with 7-day retreatment
intervals and a 7-day PHI. The petitioner has indicated that there will
be a restriction on the feeding of the leaves of root and tuber
vegetables.  This should also be added to the proposed Section B.

As a condition of registration, a livestock feeding study is required.

A revised Section F is required for the residues of fludioxonil on
vegetable, cucurbit, crop group 9 at 0.45 ppm

The requested tolerances on lemon and lime should be removed from
Section F.

Section F should be revised removing the proposed changes in the herb
subgroup 19A, fresh and dried, and the established tolerances retained. 

A revised Section F is required for the residues of fludioxonil on root
vegetables, except sugar beet subgroup 1B at 0.75 ppm.  

A revised Section F is required for the residues of fludioxonil on the
leaves of root and tuber vegetables, group 2 at 30 ppm. 

A revised Section F should be submitted for the tolerances of 0.50 ppm
on tomato and tomatillo.

A revised Section F is required for the residues of fludioxonil on
vegetable, tuberous and corm (except potato), subgroup 1D at 3.5 ppm.

ARIA recommends that the conditional registration not be removed and a
required mustard green field trial study in Region 4 remains
outstanding.

II.	ACTION REQUESTED

The Interregional Research Project Number 4 (IR-4) submitted residue
data for application of fludioxonil
(4-(2,2-difluoro-1,3-benzodioxol-4-yl)-1H-pyrrole-3-carbonitrile to
avocado, cucurbit, lemon, parsley, radish, sweet potato and tomato. 
Section 3 Registrations and establishment of the following permanent
tolerances for residues of fludioxonil were requested: 

Commodities 			Proposed Tolerance

					(ppm)

Tomato 				0.40 

Tomatillo 				0.4 

Tomato, paste				1.0

Avocado 				0.45

Black sapote 				0.45 

Canistel 				0.45

Mamey sapote				0.45

Mango 					0.45

Papaya 					0.45

Sapodilla 				0.45

Star apple 				0.45

Herb Subgroup 19A, fresh 		13 

Herb Subgroup 19A, dried 		55

Leaves of root and tuber 		40

vegetables 

Root vegetables, except			0.50

sugar beet subgroup

Lemon 					0.25

Lime 					0.25

Cucurbits 				0.60 

Tuberous and corm 			4.0

vegetables, except 

potato subgroup

The petitioner, IR-4, proposes, upon the approval of the aforementioned
tolerances, to remove established tolerances for residues of the
fungicide fludioxonil in or on the following raw agricultural
commodities:

Commodities 			Removed Tolerance

					ppm

Herb Subgroup 19A, fresh 		10 

Herb Subgroup 19A, dried 		65 

Carrot 					0.75

Turnip, greens 			10.0

III.	EXECUTIVE SUMMARY

	Fludioxonil is a contact fungicide and is active through inhibition of
protein kinase leading to reduced growth and development.  Fludioxonil
is registered for foliar application (grape, strawberry, green onion,
dry bulb onion, bushberry, caneberry, juneberry, longonberry, pistachio,
salal, and watercress), post-harvest application (stone fruit), and for
seed treatment purposes (numerous crops) with tolerances for residues of
fludioxonil ranging from 0.01 - 7.0 ppm (40 CFR 180.516(a)).  A Section
18 registration is also established for post-harvest application to
pomegranate with a tolerance for residues of fludioxonil of 5.0 ppm (40
CFR 180.516(b)).  Currently there are no tolerances established for
residues of fludioxonil in/on livestock.

 62.5 WG (water-dispersible granule; 37.5% cyprodinil and 25%
fludioxonil; EPA Registration Number 100-953) at a total of 0.22 - 0.88
lb ai/A/season to tomato, tomatillo, avocado, black sapote, canistel,
mame sapote, mango, papaya, sapodilla, star apple, fresh herbs, dried
herbs, root vegetables, leaves of root and tuber vegetables, lemon,
lime, cucurbits, and tuberous and corm vegetables.  The labels are
adequate to allow evaluation of the residue field trial data, with the
exception of root and tuber vegetables, except sugar beets.  Section B
on root and tuber vegetables, except sugar beets should be renamed root
and tuber vegetables except sugar beets and radish as the radish
requested use is not supported by appropriate residue field trial data. 
Section B should also be revised to indicate that the use on radish
should be 2 applications at 0.22 lb ai/A with 7-day retreatment
intervals and a 7-day PHI.  The petitioner has indicated that there will
be a restriction on the feeding of the leaves of root and tuber
vegetables.  This should also be added to the proposed Section B.

HED determined that the terminal residue of regulatory concern in plants
is only fludioxonil.  HED also determined that the residues of concern
in poultry, for purposes of tolerance expression and risk assessment,
are fludioxonil, CGA-344623, and I-1 and the residues of concern in
ruminant, for purpose of tolerance expression and risk assessment, are
fludioxonil and B-1. 

A method, entitled “Analytical Method for the Determination of
CGA-173506 in Crops by High Performance Liquid Chromatography,” is a
reissue of Method(s) AG-597/AG-597A and has been validated extensively
on a variety of crop matrices.  The method has successfully undergone
independent laboratory validation as well as an Agency petition method
validation (PMV) on corn grain and forage and grain sorghum.  The method
has been submitted to the FDA for inclusion in Pesticide Analytical
Manual II (PAM II) and is considered adequate for enforcement purposes. 

For tomato, avocado, parsley, radish, lemon and sweet potato, samples
were analyzed for residues of fludioxonil using Syngenta Method AG-597B,
a high performance liquid chromatography with ultraviolet detector
(HPLC/UV) method with minor modifications. For fludioxonil residues on
tomato, the lower limit of method validation (LLMV) was 0.02 ppm, and
the LOD and LOQ were 0.002 ppm and 0.007 ppm, respectively.   For
fludioxonil residues on avocado, the LOD and LOQ were 0.0055 ppm and
0.0164 ppm, respectively.  For fludioxonil residues on fresh parsley,
the LOD and LOQ were 0.010 ppm and 0.03 ppm, respectively.  The LOD and
LOQ for fludioxonil on dried parsley were 0.026 ppm and 0.077 ppm,
respectively.  For fludioxonil residues on radish, the LOD in/on radish
tops and roots were 0.003 ppm and 0.004 ppm, respectively.  The LOQ of
fludioxonil in/on radish tops and roots was 0.01 ppm.  For fludioxonil
residues on lemon, the LOD and LOQ were calculated as 0.0070 ppm and
0.021 ppm, respectively.  The LOD and LOQ in sweet potato were
calculated as 0.0057 ppm and 0.017 ppm, respectively. 

	For cucurbit vegetables, samples were analyzed for residues of
fludioxonil using Syngenta Method AG-597B, with minor modifications. 
Residues of fludioxonil were determined using HPLC and triple-quadrapole
mass spectrometric (MS/MS) detection. The LOD of fludioxonil was 0.005
ppm for cantaloupe, cucumber, and squash samples.  The LOQ of
fludioxonil was 0.01 ppm for cantaloupe, cucumber, and squash samples. 
The methods used for data gathering, which are based on the enforcement
methods and are supported by concurrent recoveries, are adequate.  

	Fludioxonil was tested according to the FDA Multiresidue Protocols C,
D, and E using sorghum, corn, and potatoes.  Recoveries were inadequate
using corn and sorghum; however, fludioxonil was recovered from
potatoes.  This information has been forwarded to the FDA (S. Willett,
3-Jan-1997).

	All the submitted residue field trial studies were supported by
adequate simultaneous storage stability data that indicate that the
residues of fludioxonil are stable for the duration of the studies with
the exception of lemon.  Previously submitted data on lemon are
sufficient to indicate that fludioxonil residues are stable in lemons
for the duration of this study.

	The requested uses of fludioxonil result in expected residues on
livestock feed items: carrot culls at 0.75 ppm (cattle and swine), and
citrus pulp at 0.25 ppm (cattle).  Ruminant and poultry metabolism
studies have been previously reviewed.  Previous dietary burdens
determined that fludioxonil tolerances were not necessary for livestock
commodities. The revised dietary burdens are equal to or lower than the
previous burdens for beef, poultry, and swine; therefore, no livestock
tolerances are required for those commodities.  However, the reasonably
balanced livestock diet for dairy cattle is higher than the previous
diet.  Based on the previously reviewed ruminant metabolism study and
the revised dietary burden, tolerances would be required for kidney,
milk, and liver.  Because carrot culls are a minor livestock feed item,
which are used in very restricted circumstances, ARIA does not recommend
for livestock tolerances at this time.  However, as a condition of
registration, a livestock feeding study is required.  

There is adequate number and geographic location of residue field trials
to support a tolerance registration on avocado.  The analytical results
show that after a total seasonal application rate of 0.88 lb ai/A at a
0-day PHI, the maximum fludioxonil residue was 0.19 ppm in treated
avocado fruit.  In addition, since avocado is the representative crop
for the proposed tropical crop group, the data also support tolerances
for black sapote, canistel, mamey sapote, mango, sapodilla, and star
apple as requested by the petitioner.  The results of the MRL
spreadsheet (see attached) indicate that the requested tolerances are
appropriate.  ARIA recommends for the requested tolerances of
fludioxonil on avocado, black sapote, canistel, mamey sapote, mango,
sapodilla, and star apple at 0.45 ppm. 

There is adequate number and geographic location of residue field trials
to support a tolerance registration on cucurbit.  At 7-day PHI, maximum
fludioxonil residues in cantaloupe, cucumber, and squash samples were
0.19, 0.08, and 0.03 ppm, respectively, after a total seasonal
application rate of 0.88 lb ai/A.  The rate used in the trials is higher
than the proposed rate; however, that is not a deficiency for this
petition.  The requested tolerances are not appropriate.  The data on
the three commodities, cantaloupes, cucumbers, and squash were analyzed
separately and the highest result of the three analyses, cantaloupes at
0.45 ppm, is the appropriate tolerance level.  In addition, the
commodity definition is incorrect.  A revised Section F is required for
the residues of fludioxonil on vegetable, cucurbit, crop group 9 at 0.45
ppm.

There is adequate number and geographic location of residue field trials
to support a tolerance registration on lemon.  The results from the
trials show that the maximum residue following a total application of
approximately 0.22 lb ai/A and a 0-day PHI was 0.19 ppm.  Since the
proposed uses are the same and these two citrus crops are similar in
size, the lemon data will also support a tolerance on lime.  There is an
existing fludioxonil tolerance on citrus fruit at 10 ppm as a result of
a post-harvest use.  That tolerance is adequate for the proposed uses on
lemon and lime; therefore, the requested tolerances on lemon and lime
should be removed from Section F.

There is adequate number and geographic location of residue field trials
to support a tolerance registration on parsley, fresh and dried.  The
analytical results show that at 6-7 days PHI, the maximum fludioxonil
residue was 3.87 ppm in fresh parsley and 22.29 ppm in dried parsley
after a total seasonal application rate of 0.88 lb ai/A.  Since there
are existing tolerances herb subgroup 19A, fresh and dried and the data
from the parsley residue field trials do not exceed those established
tolerances using the same treatment pattern, no change in the group
tolerance is required.  Section F should be revised removing the
proposed changes in the herb subgroup 19A, fresh and dried, and the
established tolerances retained.  

As a condition for the registration of fludioxonil on carrots, HED
required an additional carrot field trial, including residue decline
data).  In response, IR-4 has submitted the current carrot field trial
data.  IR-4 submitted field trial data supporting the use of fludioxonil
on carrots.  

Following four foliar applications totaling 0.90 lb ai/A, fludioxonil
residues in/on carrots were 0.48-0.69 ppm at 7-day PHI.  Fludioxonil
residues in/on carrots showed a slight but steady increase from 0 to
21-day PHI.  ARIA concludes that the condition of registration for
fludioxonil on carrots may be removed.

There is adequate number and geographic location of residue field trials
to support a tolerance registration on radish.  The petitioner requests
that the existing data for carrot be combined with the submitted radish
data and used in support of the requested tolerances on root vegetables,
except sugar beet.  It is OPP policy to analyze each representative crop
in a crop group separately and establish the group tolerance using the
highest of the individual analyses provided the data.  The appropriate
tolerance on radish is less than established carrot tolerance.  Provided
a revised Section F is received, ARIA recommends for a fludioxonil
tolerance on root vegetables, except sugar beet subgroup 1B at 0.75 ppm.
 Upon the establishment of the subgroup tolerance the existing
individual tolerance on carrots should be removed.  

The radish residue field crop trials were conducted at approximately
0.5x the proposed total use rate.  The petitioner requests that 4
applications for a total of 0.88 lb ai/A be approved for this crop
subgroup since there are radish types that have a longer growing season
than those in presented in the submitted trials and 4 applications would
be possible during their growing season.  Examination of the decline
data for carrots indicates that residues may be additive for root crops
and additional applications would possibly increase the resulting
residues on radish above the tolerance level.  ARIA recommends against
the proposed use rate.  Section B should be revised to indicate that the
use on radish be 2 applications at 0.22 lb ai/A with 7-day retreatment
intervals and a 7-day PHI.  

The petitioner is proposing a tolerance for leaves of root and tuber
vegetables, crop group 2 at 40 ppm.  The proposal is based on the
present tolerance for turnip greens at 10 ppm, which came from mustard
greens data and on the radish tops data in this petition.  There were 4
applications to mustard greens but only 2 applications to the radish
leaves resulting in half the total application rate.  The spray interval
was 7 days between the last 2 applications and a 0-day PHI in mustard
greens and 7-day PHI for radish.  IR-4 is requesting 4 applications on
leaves of root and tuber vegetables.  The residue data do support a
tolerance of 30 ppm on the leaves of root and tuber vegetables from the
data on radish top at the use rate of the submitted residue field
trials.  ARIA has determined that the use rate on radish cannot exceed
the rate used on the submitted residue field trials (see above).  The
use rate on the remainder of the root and tuber vegetables may remain as
proposed.  Section F should be revised for the establishment of a
fludioxonil group tolerance on the leaves of root and tuber vegetables
at 30 ppm. 

There is adequate number and geographic location of residue field trials
to support a tolerance registration on sweet potato.  The maximum
fludioxonil residue was 2.17 ppm after a post-harvest dip application at
0.25 lb ai/100 gal water.  The data are adequate to support a tolerance
on the tuberous and corm vegetables (except potato) subgroup.  However,
the requested tolerances are not appropriate.  In addition, the
commodity definition is incorrect.  A revised Section F is required for
the residues of fludioxonil on vegetable, tuberous and corm (except
potato), subgroup 1D at 3.5 ppm.

There is adequate number and geographic location of residue field trials
to support a tolerance registration on tomato.  Analytical results show
that with a 0-day PHI, fludioxonil residues ranged from 0.014 to 0.229
ppm in treated tomato RAC samples grown in the field, and from 0.010 to
0.169 ppm in treated tomato RAC samples grown in a greenhouse.  The
tomato data will also support a tolerance on tomatillo.  ARIA recommends
for the requested tolerances of fludioxonil on tomato and tomatillo at
0.40 ppm.  However, the Codex tolerance limit is 0.5 ppm on tomato.  A
US tolerance lower than the Codex limit would cause a barrier to tomato
imports; therefore, the tomato and tomatillo tolerances should be
raised.  A revised Section F should be submitted for the tolerances of
0.50 ppm on tomato and tomatillo.

As a condition for the registration of fludioxonil on Brassica
vegetables, HED required additional residue data from 5 field trials on
cabbage, two field trials on mustard greens, and one trial broccoli. 
Following four foliar applications totaling 0.88-0.93 lb ai/A,
fludioxonil residues were 0.06-1.11 ppm in/on cabbage at 6-8 day PHI,
1.01 and 1.04 ppm in/on mustard greens at 8-day PHI, and 0.11 and 0.14
ppm in/on broccoli at 8-day PHI.  Since the data for cabbage and
broccoli were produced with the appropriate use pattern, were of
sufficient number and correct locations as required by HED, and did not
exceed the established tolerance, ARIA concludes that the condition of
registration for fludioxonil on the Brassica, head and stem, subgroup 5A
may be removed.  HED also indicated that two trials on mustard greens
were required as a condition of registration.  Only one trial was
submitted.   Since the previously submitted data ranged so widely, the
additional trial would likely have an affect on the final tolerance
level.  Therefore, ARIA recommends that the conditional registration not
be removed and a required mustard green field trial study in Region 4
remains outstanding.

No citrus processing studies were submitted with this petition. 
Previous studies indicated that in citrus processed commodities
fludioxonil residues concentrate only on citrus oil at 61x and on pulp
at 2.1x.  The expected residues on citrus oil from this use at 9.76 ppm 
will not exceed the existing tolerance on citrus fruit and would be
considerably lower than the existing tolerance on grapefruit oil at 500
ppm.  Similarly, the expected residues on citrus pulp as a result of the
proposed use at 0.37 ppm will also not exceed the existing tolerance on
citrus fruit at 10 ppm.  No change in tolerances is required as a result
of the proposed use on lemon and lime.  

Fludioxonil was applied to tomato at a total of approximately 0.88 lb
ai/A, and harvested at 0-days PHI after final treatment.  Tomato RAC
samples were processed into puree and paste.  Fludioxonil residues
reduced in puree by a factor of 0.3x.  In paste samples, fludioxonil
residues were concentrated by factor of 1.1x.  The submitted tomato
processing study indicates that fludioxonil residues do not appreciably
concentrate in tomato processed commodities made from treated tomato
samples; therefore, tolerances are not required for tomato processed
commodities.

	The proposed label indicates that only those crops listed on the label
may be rotated to a treated field at 0-day following treatment and all
other crops may be planted after 30 days.  Based on the results of the
confined and field rotational crop studies and the proposed application
rates, the label rotational crop restrictions are acceptable.     

IV.	DETAILED CONSIDERATIONS

	Fludioxonil is a contact fungicide, which is active through inhibition
of protein kinase leading to reduced growth and development. 
Fludioxonil is registered for foliar application, post-harvest
application, and for seed treatment purposes with tolerances for
residues of fludioxonil ranging from 0.01 to 500 ppm (40 CFR
180.516(a)).

Table 1.  Nomenclature of Test Compound.

Compound

	

Common name	

Fludioxonil

Company experimental names	

CGA-173506 and Fludioxonyl

IUPAC name	

4-(2,2-difluoro-1,3-benzodioxol-4-yl)-1H-pyrrole-3-carbonitrile

CAS name	4-(2,2-difluoro-1,3-benzodioxol-4-yl)-1H-pyrrole-3-carbonitrile

CAS #	131341-86-1

End-use products/EP	Switch 62.5 WG (EPA Reg. No. 100-953), Scholar 50 WP
(EPA Reg. No. 100-969)

Table 2.  Physicochemical Properties of the Technical Grade Fludioxonil.

Parameter	Value	Reference

Melting point	199.8°C	DER 46715501, G. Kramer, 11/16/06

pH	8-9 @ 25°C (1% aqueous Dispersion)

	Density	1.54 g/cm3 typical at 23°C

	Water solubility (25 C)	1.8 mg/L

	Solvent solubility (mg/L @ 25°C)	Ethanol 44,000

Acetone 190,000

Toluene 2,700

n-Octanol 20,000

n-Hexane 7.8

	Vapor pressure (25°C)	2.9 x 10-9 mm Hg

	Dissociation constant, pKa	pKa1 <0

pKa2 ~ 14.1

	Octanol/water partition coefficient, Log(KOW)	4.12 @ 25°C

	UV/visible absorption spectrum	12,384 l/mol x cm @266 nm (neutral
solution)

12,327 l/mol x cm @ 265 nm (acidic solution)

11,790 l/mol x cm @ 271 nm (basic solution)

	

V.	RESULTS/DISCUSSIION

860.1200  Directions for Use

Table 3.  Summary of Directions for Use of Fludioxonil.

Applic. Timing, Type, and Equip.	

Formulation

[EPA Reg. No.]	

Applic. Rate 

(lb ai/A)	

Max. No. Applic. per Season	

Max. Seasonal Applic. Rate

(lb ai/A)	

PHI

(days)	

Use Directions and Limitations

Tomato & Tomatillo

Ground at first appearance of disease	

Switch 62.5 WG

[100-953]	

0.17-0.22	

5	

0.88	

0	

A minimum of 20 gallons of water per acre is recommended.

RTI at 7-10 day intervals if conditions remain favorable for disease

development.

Avocado, Black Sapote, Canistel, Mamey Sapote, Mango, Papaya, Sapodilla,
and Star Apple

Ground at first appearance of disease	

Switch 62.5 WG

[100-953]	

0.17-0.22	

5	

0.88	

0	

A minimum of 80 gallons of water per acre is recommended.

RTI at 7-10 day intervals if conditions remain favorable for disease

development.

Herbs Dry and Fresh

Ground at first appearance of disease	

Switch 62.5 WG

[100-953]	

0.17-0.22	

5	

0.88	

7	

A minimum of 30 gallons of water per acre is recommended.

RTI at 7-10 day intervals if conditions remain favorable for disease

development.

Root Vegetables, except Sugar Beet

Ground at first appearance of disease	

Switch 62.5 WG

[100-953]	

0.17-0.22	

5	

0.88	

7	

A minimum of 15 gallons of water per acre is recommended.

RTI at 7-10 day intervals if conditions remain favorable for disease

development.

Lemon and Lime

Ground at first appearance of disease	

Switch 62.5 WG

[100-953]	

0.17-0.22	

1	

0.22	

0	

A minimum of 15 gallons of water per acre is recommended.

Cucurbit Crops

Ground at first appearance of disease	

Switch 62.5 WG

[100-953]	

0.17-0.22	

4	

0.88	

1	

A minimum of 30 gallons of water per acre is recommended.

RTI at 7-10 day intervals if conditions remain favorable for disease
development.

Tuberous and Corm Vegetables

Dip application in water, wax/emulsion, or aqueous dilution of wax/oil
emulsion.	Scholar 50 WP

[100-969]	0.25-0.50	1	0.50	0	Dip in 100 gal. for approximately 30
seconds and allow fruit to drain.

Keep treated vegetables out of sunlight. 

Conclusions:  The labels are adequate to allow evaluation of the residue
field trial data, with the exception of root and tuber vegetables,
except sugar beets.  Section B on root and tuber vegetables, except
sugar beets should be renamed root and tuber vegetables except sugar
beets and radish as the radish requested use is not supported by
appropriate residue field trial data.  Section B should also be revised
to indicate that the use on radish should be 2 applications at 0.22 lb
ai/A with 7-day retreatment intervals and a 7-day PHI.  

	The petitioner has indicated that there will be a restriction on the
feeding of the leaves of root and tuber vegetables (email, D. Thompson,
4/3/08).  This should also be added to the proposed Section B.

860.1300 Nature of the Residue - Plants

DP Num: 262022, W. Donovan, 1/18/00

DER 45821801, T. Bloem, 2/12/02

PP#s: 2E6448, 2E6486, 2E6462, and 3E6526; DP Num: 287808, 287810,
287812, and 287814; T. Bloem; 2/12/03

	HED determined that the terminal residue of regulatory concern in
peach, grape, and onion following foliar application is only fludioxonil
(D262022, W. Donovan, 1/18/00).  This decision was based on peach,
grape, and onion metabolism studies which indicated that fludioxonil was
the only compound present at levels exceeding 0.01 ppm or 10% TRR.  As
with the previous metabolism studies, an additional lettuce metabolism
study resulted in only fludioxonil at concentrations >10% TRR.  A
comparison of the head lettuce metabolism study with those previously
reviewed indicates that the only lettuce specific metabolites identified
are the lactic acid conjugate of CGA 173506 and the glucose conjugate of
CGA 344623 (45821801, T. Bloem, 2/12/02; see Attachment 1, Chemical
Structures below).  Unconjugated CGA 173506 and CGA 344623 were also
identified in previous metabolism studies.  Since the only unique
metabolites identified in the lettuce metabolism studies were conjugated
forms of compounds previously identified and the lettuce metabolism
study also resulted in only fludioxonil at concentrations greater >10%
TRR, HED concluded that the metabolic pathway in three dissimilar crops
has been demonstrated to be similar and the residues of concern in
plants is only fludioxonil (PP#s: 2E6448, 2E6486, 2E6462, and 3E6526; DP
Num: 287808, 287810, 287812, and 287814; T. Bloem; 2/12/03).

860.1300 Nature of the Residue – Livestock

DP Num: 262022, W. Donovan, 1/18/00

PP#s: 2E6448, 2E6486, 2E6462, and 3E6526; DP Num: 287808, 287810,
287812, and 287814; T. Bloem; 2/12/03

	HED determined that the residues of concern in poultry, for purposes of
tolerance expression and risk assessment, are fludioxonil, CGA-344623,
and I-1 and the residues of concern in ruminant, for purpose of
tolerance expression and risk assessment, are fludioxonil and B-1. 
CGA-344623, I-1, and B-1 (see Attachment 1, Chemical Structures below)
were included as residues of concern since they contain the nitrile
functional group and constituted greater than 10% of the TRR in the
laying hen and/or lactating goat metabolism. 

860.1340 Residue Analytical Methods

DP Num: 246235, W. Wassell, 8/31/98

PP#4F4315: DP Num: 206301, S. Willett, 3/1/95

PP#4F4315; DP Num: 217129, S. Willett, 8/14/95

DER 47161101-06 & 47161108, W. Cutchin, in process

Enforcement Plants

A method, entitled “Analytical Method for the Determination of
CGA-173506 in Crops by High Performance Liquid Chromatography,” is a
reissue of Method(s) AG-597/AG-597A and has been validated extensively
on a variety of crop matrices (>60 commodities) to a lower limit of
0.01-0.05 ppm (DP Num: 246235, W. Wassell, 8/31/98).  The method has
successfully undergone independent laboratory validation (PP#4F4315: DP
Num: 206301, S. Willett, 3/1/95) as well as an Agency petition method
validation (PMV) on corn grain and forage and grain sorghum (PP#4F4315;
DP Num: 217129, S. Willett, 8/14/95).  The method has been submitted to
the FDA for inclusion in PAM II (S. Willett, dated 1/3/97) and is
considered adequate for enforcement purposes. 

Data Gathering Plants

For tomato, avocado, parsley, radish, lemon and sweet potato, samples
were analyzed for residues of fludioxonil using Syngenta Method AG-597B,
with minor modifications.  Briefly, samples were ground in dry ice,
extracted with acetonitrile:water (90:10, v/v), filtered, and
concentrated.  Residues were diluted with a saturated sodium chloride
solution and partitioned into methyl tert-butyl ether.  Residues were
solvent exchanged into toluene, diluted with hexane, and cleaned up
using a silica solid-phase extraction cartridge eluted with
dichloromethane:toluene (50:50, v/v).  Residues were concentrated to
dryness, reconstituted in methanol:water and further purified by passage
through a phenyl solid-phase extraction cartridge eluted with acetone. 
The cleaned extract was evaporated to dryness, reconstituted in
hexane:methanol:isopropanol (90:5:5, v/v/v), and analyzed by HPLC/UV at
268 nm using a normal phase amino column and external standards.  For
fludioxonil residues on tomato, the lower limit of method validation
(LLMV) was 0.02 ppm, and the LOD and LOQ were 0.002 ppm and 0.007 ppm,
respectively.   For fludioxonil residues on avocado, the LOD and LOQ
were 0.0055 ppm and 0.0164 ppm, respectively.  For fludioxonil residues
on fresh parsley, the LOD and LOQ were 0.010 ppm and 0.03 ppm,
respectively.  The LOD and LOQ for fludioxonil on dried parsley were
0.026 ppm and 0.077 ppm, respectively.  For fludioxonil residues on
radish, the LOD in/on radish tops and roots were 0.003 ppm and 0.004
ppm, respectively.  The LOQ of fludioxonil in/on radish tops and roots
was 0.01 ppm.  For fludioxonil residues on lemon, the LOD and LOQ were
calculated as 0.0070 ppm and 0.021 ppm, respectively.  The LOD and LOQ
in sweet potato were calculated as 0.0057 ppm and 0.017 ppm,
respectively. 

	For cucurbit vegetables, samples were analyzed for residues of
fludioxonil using Syngenta Method AG-597B, with minor modifications. 
Briefly, chopped and homogenized cantaloupe, cucumber, and squash
samples were extracted with acetonitrile/water (90:10, v/v), and then
cleaned up by solid phase extraction.  The cleaned extract was directly
diluted in acetonitrile/water (30:70, v/v).  Residues of fludioxonil
were determined using gradient elution HPLC and triple-quadrapole mass
spectrometric (MS/MS) detection.  MS/MS detection was accomplished by
monitoring the transition from the [M-1] molecular ion to a daughter ion
at 179.8 amu with the mass spectrometer operated in negative-ion,
electrospray ionization mode.  The LOD of fludioxonil was 0.005 ppm for
cantaloupe, cucumber, and squash samples.  The LOQ of fludioxonil was
0.01 ppm for cantaloupe, cucumber, and squash samples.

Conclusions:  There are adequate methods available to enforce the
proposed tolerances.  The methods used for data gathering, which are
based on the enforcement methods and are supported by concurrent
recoveries, are adequate.  

860.1360 Multiresidue Methods

D206301, S. Willett, 3/1/95

S. Willett, 1/3/97 

	Fludioxonil was tested according to the FDA Multiresidue Protocols C,
D, and E using sorghum, corn, and potatoes.  Recoveries were inadequate
using corn and sorghum; however, fludioxonil was recovered from
potatoes, a representative nonfatty crop (D206301, S. Willett,
1-Mar-1995).  Testing was not conducted according to protocols A and B
as fludioxonil does not have an N-methylcarbamate structure (protocol A)
nor is it an acid or phenol (protocol B).  Recoveries from potatoes
(using multiresidue protocol D) were 49-121% at the 0.05 ppm
fortification level, and 78-87% at the 0.5 ppm fortification level.  
This information has been forwarded to the FDA (S. Willett, 3-Jan-1997).

860.1380 Storage Stability

D246235, W. Wassell, 8/31/98;

D258870, W. Donovan, 12/20/99

DER 46715502, G. Kramer, 11/16/06

DER 47161101-06 & 47161108, W. Cutchin, in process

	The petitioner has previously demonstrated that residues of fludioxonil
are stable on field corn (forage and grain; 24 months), sorghum hay (24
months), grape (28 months), potato tubers (24 months), and grapes (22
months) when stored frozen (D246235, W. Wassell, 8/31/98; D258870, W.
Donovan, 12/20/99).  

Avocado:  The maximum storage interval for field treated avocado samples
in the study was 309 days.  The results of a freezer storage stability
study demonstrated that fludioxonil residues were stable in avocado
samples stored frozen 414 days.

Cucurbit:  The maximum storage interval for field treated cantaloupe,
cucumber, and squash samples was about 20 months.  The results of a
freezer storage stability study demonstrated that fludioxonil residues
were stable in cantaloupe, cucumber, and squash samples stored frozen
for up to 24-27 months.

Lemon:  The maximum storage stability interval of fludioxonil for field
treated samples in this study was 639 days.  In previous studies
submitted in support of a post-harvest use on lemon, study authors cited
storage stability data indicating that fludioxonil is stable at -20°C
for at least 13.8 months in whole citrus fruit and 9.4 months in citrus
juice (46715502, G. Kramer, 11/16/06).

Parsley:  The maximum storage interval was 390 days for field fresh
parsley samples and 416 days for dried parsley samples.  The results of
a freezer storage stability study demonstrated that fludioxonil residues
were stable stored frozen in fresh parsley samples for up to 432 days
and dried parsley samples for up to 434 days.

Radish:  The maximum storage interval for field treated radish samples
was 702 days for tops and 763 days for roots.  The results of a freezer
storage stability study demonstrated that fludioxonil residues were
stable in radish tops and roots stored frozen for up to 756 days and 774
days, respectively.

Sweet Potato:  The maximum storage interval for field-treated sweet
potato samples in this study was 308 days.  Storage stability testing
was performed after 312 days of frozen storage and the results
demonstrated stability.  

Tomato:  The maximum storage interval for field treated samples was 343
days for the RAC, 292 days for puree, and 288 days for paste.  The
results of a freezer storage stability study demonstrated that
fludioxonil residues were stable in tomato samples stored frozen for up
to 475 days for RAC, 337 days for puree, and 330 days for paste.

Conclusions:  All the submitted residue field trial studies were
supported by adequate simultaneous storage stability data that indicate
that the residues of fludioxonil are stable for the duration of the
studies with the exception of lemon.  Previously submitted data on lemon
are sufficient to indicate that fludioxonil residues are stable in
lemons for the duration of this study 

860.1400 Water, Fish, and Irrigated Crops

There are no existing or proposed water, fish, or crop irrigation uses
for fludioxonil; therefore, a discussion of such uses is not necessary.

860.1460 Food Handling

There are no existing or proposed food handling uses for fludioxonil;
therefore, a discussion of food handling uses is not necessary.

860.1480 Meat, Milk, Poultry, and Eggs

PP#s: 2E6448, 2E6486, 2E6462, and 3E6526; DP Num: 287808, 287810,
287812, and 287814; T. Bloem; 2/12/03

DP NUM: 210762, S. Willett, 12/18/95

	The requested uses of fludioxonil result in expected residues on
livestock feed items: carrot culls at 0.75 ppm (cattle and swine), and
citrus pulp at 0.25 ppm (cattle).  Turnip roots and tops are also a feed
item, but the registrant has indicated that the label will be amended to
preclude treatment to turnips which will be used for livestock feed (see
Direction for Use, above).  Ruminant and poultry metabolism studies have
been previously reviewed by HED (D210762, S. Willett, 12/18/95).  

	Previous reviews showed that based on the established/recommended
tolerances, the following maximum theoretical dietary burden (MTDB) were
calculated: beef cattle - 0.13 ppm (potato processed waste and potato
culls), dairy cattle - 0.11 ppm (potato processed waste, potato culls,
and turnip tops), poultry - 0.03 ppm (sorghum grain and flax seed meal),
and swine - 0.02 ppm (sorghum grain and popcorn grain; PP#s: 2E6448,
2E6486, 2E6462, and 3E6526; DP Num: 287808, 287810, 287812, and 287814;
T. Bloem; 2/12/03).  Those MTDB were used to determine that fludioxonil
tolerances were not necessary for livestock commodities.  Dietary
burdens were recalculated reflecting the most recent guidance concerning
revisions of feedstuff percentages and reasonably balanced livestock
diets were constructed (e-mail, J. Stokes, 4/10/08).  

Table 4.A.  Maximum Reasonable Dietary Burden Calculations With Carrot
Culls

 Feedstuff	Type	Tolerance	DM	Maximum % of Diet	Dietary Burden, ppm

Beef	Dairy	Poultry	Swine	Beef	Dairy	Poultry	Swine

Grass, nongrass, and/or cereal grain forage/silage	R	0.01	40%	0%	45%	0%
0%	0.000	0.011	0.000	0.000

Grass, nongrass, and/or cereal grain hay	CC	0.01	89%	15%	0%	0%	0%	0.002
0.000	0.000	0.000

potato, processed waste	CC	0.02	15%	30%	0%	0%	0%	0.040	0.000	0.000	0.000

Carrot, culls	CC	0.75	12%	0%	10%	0%	0%	0.000	0.625	0.000	0.000

Cereal, grain	CC	0.02	88%	50%	35%	80%	85%	0.011	0.008	0.016	0.017

Sunflower (safflower, peanut, flax, rapeseed) meal	PC	0.01	92%	5%	10%
20%	15%	0.001	0.001	0.002	0.002

Total	 	 	 	100%	100%	100%	100%	0.05	0.65	0.02	0.02

DM =Dry matter

Table 4.B.  Maximum Reasonable Dietary Burden Calculations Without
Carrot Culls

 Feedstuff	Type	Tolerance	DM	Maximum % of Diet	Dietary Burden, ppm

Beef	Dairy	Poultry	Swine	Beef	Dairy	Poultry	Swine

Grass, nongrass, and/or cereal grqain forage/silage	R	0.01	40%	0%	45%	0%
0%	0.000	0.011	0.000	0.000

Grass, nongrass, and/or cereal grain hay	CC	0.01	89%	15%	0%	0%	0%	0.002
0.000	0.000	0.000

Potato, processed waste	CC	0.02	15%	30%	10%	0%	0%	0.040	0.013	0.000
0.000

Corn, field, grain	CC	0.02	88%	50%	35%	80%	85%	0.011	0.008	0.016	0.017

Sunflower meal	PC	0.01	92%	5%	10%	20%	15%	0.001	0.001	0.002	0.002

Total	 	 	 	100%	100%	100%	100%	0.05	0.03	0.02	0.02

DM =Dry matter

Table 5.  TRR in Goat Tissues and Milk Following Dosing with
[14C-Pyrrole]-Fludioxonil

Matrix	TRR

(ppm)	TRR normalized

to TDB1(ppm)	TRR normalized

to TDB1(ppm)

With Carrot Culls	Without Carrot culls

blood	

0.47, 0.49	0.003	<0.001

plasma	

0.64, 0.68	0.004	<0.001

liver	

6.18, 5.37	0.036	0.001

kidney	

2.92, 2.89	0.018	<0.001

heart	

0.22, 0.16	0.001	<0.001

tenderloin	

0.09, 0.05	<0.001	<0.001

leg muscle	

0.07, 0.06	<0.001	<0.001

omental fat	

0.26, 0.11	0.001	<0.001

perirenal fat	

0.28, 0.10	0.001	<0.001

milk day 1	

1.06, 1.20	0.007	<0.001

milk day 2	

1.13, 1.76	0.009	<0.001

milk day 3	

1.24, 2.04	0.010	<0.001

milk day 4	

1.64, 2.92	0.014	<0.001

					1  calculated from average TRR ppm of 14C-pyrrole fludioxonil
equivalents

Conclusions:   The revised dietary burdens are equal to or lower than
the previous burdens for beef, poultry, and swine; therefore, no
livestock tolerances are required for those commodities.  However, the
reasonably balanced livestock diet for dairy cattle is higher than the
previous diet.  Based on  \the previously reviewed ruminant metabolism
study and the revised dietary burden, tolerances would be required for
kidney, milk, and liver (Table 5).  Because carrot culls are a minor
livestock feed item, which are used in very restricted circumstances,
ARIA does not recommend for livestock tolerances at this time.  However,
as a condition of registration, a livestock feeding study is required. 
Upon receipt and review of the study, the necessity for fludioxonil
tolerances on livestock commodities will be reassessed.

860.1500 Crop Field Trials

DER 45795301-02, T. Bloem, 2/12/03

DER 45726102, T. Bloem, 2/12/03

PP#s: 2E6448, 2E6486, 2E6462, and 3E6526; DP Num: 287808, 287810,
287812, and 287814; T. Bloem; 2/12/03

DER 47161101-06, 47161108, 47169310-11, W. Cutchin, in process

Avocado

IR-4 has submitted field trial data for fludioxonil on avocado.  Six
trials were conducted in the 2003-growing season in Florida, Texas, and
California (4).  The number and locations of field trials are in
accordance with OPPTS Guideline 860.1500.  At each trial, avocado was
treated with four foliar applications of Switch 62.5 WG at the
approximate rate of 0.219 lb fludioxonil/A for a total of approximately
0.875 lb ai/A.  The test substance was mixed with water without any
adjuvant.  Avocado samples were collected on the day of the final
application. 

Samples were analyzed for residues of fludioxonil using HPLC/UV) method
(based on Syngenta Method AG-597B), which was adequately validated in
conjunction with the field sample analyses.  In this study, the LOD and
LOQ for fludioxonil were 0.0055 ppm and 0.0164 ppm, respectively. 

The maximum storage interval for field treated avocado samples was 309
days.  Results of a freezer storage stability study demonstrated that
fludioxonil residues were stable in avocado stored frozen for up to 414
days.  The analytical results show that after a total seasonal
application rate of 0.88 lb ai/A at a 0-day PHI, the maximum fludioxonil
residue was 0.19 ppm in treated avocado fruit.

Conclusions:  There is adequate number and geographic location of
residue field trials to support a tolerance registration on avocado.  In
addition, since avocado is the representative crop for the proposed
tropical crop group, the data also support tolerances for black sapote,
canistel, mamey sapote, mango, sapodilla, and star apple as requested by
the petitioner.  The results of the MRL spreadsheet (see attached)
indicate that the requested tolerances are appropriate.  ARIA recommends
for the requested tolerances of fludioxonil on avocado, black sapote,
canistel, mamey sapote, mango, sapodilla, and star apple at 0.45 ppm. 

Cucurbit

IR-4 has submitted field trial data for fludioxonil on cucurbit
(cantaloupe, cucumber, and squash).  Eighteen trials were conducted in
the 2004-growing season.  The field trials were conducted in California
(5), Florida (2), Georgia (2), Illinois (2), Michigan, New York, North
Carolina, South Carolina, Texas (2), and Wisconsin.  The number and
locations of field trials are in accordance with OPPTS Guideline
860.1500.  At each trial, the crops (cantaloupe, cucumber, and squash)
were treated with four foliar broadcast applications of Switch 62.5 WG
at the approximate rate of 0.22 lb fludioxonil/A for a total seasonal
rate of 0.88 lb ai/A.  The test substance was mixed with water without
any adjuvant.  Cantaloupe, cucumber, and squash samples were collected
at pre-harvest intervals (PHIs) of 1 and 7 days. 

	Samples were analyzed for residues of fludioxonil using an HPLC/MS/MS
method (based on Syngenta Method AG-597B), which was adequately
validated in conjunction with the field sample analyses.  In this study,
the LOD and LOQ of fludioxonil were 0.005 ppm and 0.01 ppm,
respectively, for cantaloupe, cucumber, and squash.  The maximum storage
intervals for field treated cantaloupe, cucumber, and squash samples
were 20.1, 19.6, and 19.9 months, respectively.  Results of a freezer
storage stability study demonstrated that fludioxonil residues were
stable in cantaloupe, cucumber, and squash samples stored frozen for up
to 24–27 months.  Analytical results show that at a 1-day PHI, maximum
fludioxonil residues in cantaloupe, cucumber, and squash samples were
0.52, 0.13, and 0.08 ppm, respectively, after a total seasonal
application rate of 0.88 lb ai/A.  At 7-day PHI, maximum fludioxonil
residues in cantaloupe, cucumber, and squash samples were 0.19, 0.08,
and 0.03 ppm, respectively, after a total seasonal application rate of
0.88 lb ai/A.

Conclusions:  There is adequate number and geographic location of
residue field trials to support a tolerance registration on cucurbit. 
However, the MRL spreadsheet (see attached) indicates that the requested
tolerances are not appropriate.  The data on the three commodities,
cantaloupes, cucumbers, and squash were analyzed separately and the
highest result of the three analyses, cantaloupes at 0.45 ppm, is the
appropriate tolerance level.  In addition, the commodity definition is
incorrect.  A revised Section F is required for the residues of
fludioxonil on vegetable, cucurbit, crop group 9 at 0.45 ppm.

Lemon

IR-4 has submitted field trial data for fludioxonil on lemons.  Five
trials were conducted in the United States encompassing Zone 10 [CA]
during the 2004 and 2005 growing seasons.  The number of field trials is
in accordance with OPPTS Guideline 860.1500.  At each test location,
lemons received one foliar application of Switch 62.5 WG at a rate of
approximately 0.22 lb ai/A.  No adjuvant was added to the spray mixture
for all applications.  Lemons were harvested at a 0-day PHI. 

Sample analysis for residues of fludioxonil was determined using the
working outline, 9.98, derived from Syngenta method AG-597B.  The LOD
and LOQ were as 0.007 ppm and 0.021 ppm, respectively.  The maximum
storage interval of fludioxonil for field treated samples in this study
was 639 days.  Previously submitted data on citrus and numerous other
commodities are sufficient to indicate that fludioxonil residues are
stable in lemons for the duration of this study.  The results from the
trials show that the maximum residue following a total application of
approximately 0.22 lb ai/A and a 0-day PHI was 0.19 ppm.

Conclusions:  There is adequate number and geographic location of
residue field trials to support a tolerance registration on lemon.  In
addition, the petitioner has requested that the data be sued to support
the use on lime.  Since the proposed uses are the same and these two
citrus crops are similar in size, the lemon data will also support a
tolerance on lime.  The results of the MRL spreadsheet (see attached)
indicate that the requested tolerances are appropriate.  However, there
is an existing fludioxonil tolerance on citrus fruit at 10 ppm as a
result of a post-harvest use.  That tolerance is adequate for the
proposed uses on lemon and lime; therefore, the requested tolerances on
lemon and lime should be removed from Section F. 

Parsley

IR-4 has submitted field trial data for fludioxonil on parsley.  Four
trials were conducted in the 2003-growing season.  The field trials were
conducted in Florida, California, Ohio, and Oregon.  The number and
locations of the field trials are in accordance with OPPTS Guideline
860.1500.  At each trial, parsley was treated with four foliar
applications of Switch 62.5 WG at the approximate rate of 0.22 lb
fludioxonil/A for a total of approximately 0.88 lb ai/A.  The test
substance was mixed with water without any adjuvant.  Parsley fresh
samples were collected at a PHI of 6-7 days.  In each trial, two treated
fresh parsley samples were dried in dryers or greenhouses.

Samples were analyzed for residues of fludioxonil using HPLC/UV method
(based on Syngenta Method AG-597B), which was adequately validated in
conjunction with the field sample analyses.  In this study, the LOD and
LOQ for fludioxonil on fresh parsley were 0.01 ppm and 0.03 ppm,
respectively.  The LOD and LOQ for fludioxonil on dried parsley were
0.026 ppm and 0.077 ppm, respectively.  Storage stability data were
presented that show that residues of interest were stable for the
duration of the study.  The analytical results show that at 6-7 days
PHI, the maximum fludioxonil residue was 3.87 ppm in fresh parsley and
22.29 ppm in dried parsley after a total seasonal application rate of
0.88 lb ai/A.

Conclusions:  There is adequate number and geographic location of
residue field trials to support a tolerance registration on parsley,
fresh and dried.  The petitioner requests that the existing data for
fresh and dry basil and chive (DER 45795301-02, T. Bloem, 2/12/03) be
combined with the submitted parsley data and used in support of the
requested tolerances on the herb subgroup 19A, fresh and dried at 13 ppm
and 55 ppm, respectively.  It is OPP policy to analyze each crop in a
group separately and establish the group tolerance using the highest of
the individual analyses provided the data are within a 5x range.  In
addition, the original analysis of the fresh basil data incorporated
normalization calculations (PP#s: 2E6448, 2E6486, 2E6462, and 3E6526; DP
Num: 287808, 287810, 287812, and 287814; T. Bloem; 2/12/03), lowering
the highest reported residues.  Since there are existing tolerances herb
subgroup 19A, fresh and dried at 10 ppm and 65 ppm, respectively, and
the data from the parsley residue field trials do not exceed those
established tolerances using the same treatment pattern, no change in
the group tolerance is required.  Section F should be revised removing
the proposed changes in the herb subgroup 19A, fresh and dried, and the
established tolerances retained.  

Root Vegetables, except Sugar Beet

Carrot

As a condition for the registration of fludioxonil on carrots (Switch™
62.5 WG; EPA Reg. No. 100-953), HED required an additional carrot field
trial, including residue decline data (PP#2E6462, DP# 287808, T. Bloem,
2/12/2003).  In response, IR-4 has submitted the current carrot field
trial data. 

IR-4 submitted field trial data supporting the use of fludioxonil on
carrots.  In a single field trial conducted in Zone 3 during 2004, a
multiple active ingredient, water-dispersible granular (WDG)
formulation, containing 25% fludioxonil and 37.5% cyprodinil, was
applied to carrots as four directed foliar applications at retreatment
intervals (RTIs) of 7-21 days.  The application rates for fludioxonil
were 0.222-0.228 lb ai/A for a total of 0.90 lb ai/A/season. 
Applications were made using ground equipment in volumes of 30-31 gal/A,
and did not include the use of any spray adjuvants.  Duplicate control
and treated samples of carrot roots were collected at 0, 3, 7, 14, and
21 days after the last application (DAT).  Samples were stored frozen up
to 113 days, an interval supported by available storage stability data.

Residues of fludioxonil in/on carrots were determined using an HPLC/UV
method (Method AG-597B), which was adequately validated in conjunction
with the analysis of field trial samples.  For this method, residues are
extracted with acetonitrile (ACN):water, concentrated, and partitioned
into methyl tert-butyl ethyl (MTBE).  Residues were then cleaned up
using silica and phenyl solid-phase extraction (SPE) cartridges, and
analyzed by HPLC/UV using a normal-phase amino column.  The LLMV for
fludioxonil residues is 0.02 ppm in/on carrots.  The LOQ was 0.023 ppm,
and the LOD was 0.008 ppm.

Following four foliar applications totaling 0.90 lb ai/A, fludioxonil
residues in/on carrots were 0.35-0.45 ppm at 0 DAT, 0.39-0.54 ppm at 3
DAT, 0.48-0.69 ppm at 7 DAT, 0.43-0.63 ppm at 14 DAT and 0.61-0.63 ppm
at 21 DAT.  Fludioxonil residues in/on carrots showed a slight but
steady increase from 0 to 21 DAT, averaging 0.40 ppm at 0 DAT and 0.62
ppm at 21 DAT.  

Conclusions:  The carrot field trial data are adequate and indicate that
residues of fludioxonil increased slightly from 0 to 21 DAT.  ARIA
concludes that the condition of registration for fludioxonil on carrots
(Switch™ 62.5 WG; EPA Reg. No. 100-953) may be removed.

Radish

IR-4 has submitted field trial data for fludioxonil on radish.  Six
trials were conducted in the 2004-growing season.  The field trials were
conducted in New York, Florida (2), Ohio, California, and Washington. 
At each trial, radish crop was treated with two foliar applications of
Switch 62.5 WG at 0.22 lb fludioxonil/A for a total of approximately
0.44 lb ai/A.  The test substance was mixed with water without any
adjuvant.  Radish tops and root samples were collected at PHIs of 7 to 8
days. 

Samples were analyzed for residues of fludioxonil using HPLC/UV method
(based on Syngenta Method AG-597B), which was adequately validated in
conjunction with the field sample analyses.  In this study, the LOD for
fludioxonil in/on radish tops and radish roots were 0.003 ppm and 0.004
ppm, respectively.  The LOQ for fludioxonil in/on radish tops and radish
roots is 0.01 ppm.  The maximum storage interval for field treated
radish samples was 702 days for tops and 763 days for roots.  The
results of a freezer storage stability study demonstrated that
fludioxonil residues were stable when stored frozen in radish tops and
root samples for up to 756 days and 774 days, respectively.  Analytical
results show that at 7 – 8 days PHI, maximum fludioxonil residues
in/on radish tops and roots were 11.3 ppm and 0.13 ppm, respectively,
after a total seasonal application rate of 0.44 lb ai/A.

Conclusions:  There is adequate number and geographic location of
residue field trials to support a tolerance registration on radish.  The
petitioner requests that the existing data for carrot (DER 45682401, T.
Bloem, 2/12/03) be combined with the submitted radish data and used in
support of the requested tolerances on root vegetables, except sugar
beet.  It is OPP policy to analyze each representative crop in a crop
group separately and establish the group tolerance using the highest of
the individual analyses provided the data are within a 5x range.  The
MRL spreadsheet (see attached) indicates that the appropriate tolerance
on radish is less than but within 5x of the established carrot
tolerance.  Provided a revised Section F is received, ARIA recommends
for a fludioxonil tolerance on root vegetables, except sugar beet
subgroup 1B at 0.75 ppm.  Upon the establishment of the subgroup
tolerance the existing individual tolerance on carrots should be
removed.  

The radish residue field crop trials were conducted at approximately
0.5x the proposed total use rate.  The petitioner states that the radish
data was developed with 2 applications due to a very short growing
period from planting to harvest but that the retreatment interval was 7
days in both radish and carrot studies and the PHI is the same.  The
petitioner requests that 4 applications for a total of 0.88 lb ai/A be
approved for this crop subgroup since there are radish types that have a
longer growing season than those in presented in the submitted trials
and 4 applications would be possible during their growing season. 
Examination of the decline data for carrots indicates that residues may
be additive for root crops and additional applications would possibly
increase the resulting residues on radish above the tolerance level. 
ARIA recommends against the proposed use rate.  Section B should be
revised to indicate that the use on radish be 2 applications at 0.22 lb
ai/A with 7-day retreatment intervals and a 7-day PHI.  

The petitioner is proposing a tolerance for leaves of root and tuber
vegetables, crop group 2 at 40 ppm.  The proposal is based on the
present tolerance for turnip greens at 10 ppm, which came from mustard
greens data (PP# 2E6485) and on the radish tops data in this petition. 
There were 4 applications to mustard greens but only 2 applications to
the radish leaves resulting in half the total application rate.  The
spray interval was 7 days between the last 2 applications and a 0-day
PHI in mustard greens and 7-day PHI for radish.  IR-4 is requesting 4
applications of Switch on leaves of root and tuber vegetables.  The
petitioner contends that radish leaves should provide an appropriate
replacement for beet leaves as they are slightly more pubescent than
beet leaves.  It is OPP policy to analyze each representative crop in a
crop group separately and establish the group tolerance using the
highest of the individual analyses.  The residue data do support a
tolerance of 30 ppm on the leaves of root and tuber vegetables from the
data on radish top at the use rate of the submitted residue field trials
(see attached MRL Spreadsheet).  ARIA has determined that the use rate
on radish cannot exceed the rate used on the submitted residue field
trials (see above).  The use rate on the remainder of the root and tuber
vegetables may remain as proposed.  Section F should be revised for the
establishment of a fludioxonil group tolerance on the leaves of root and
tuber vegetables at 30 ppm. Upon establishment of the tolerance on
leaves of root and tuber vegetables, the tolerance on turnip greens may
be removed.

Should the petitioner wish to establish the requested group tolerances
and use rates, residue field trial studies should be conducted with the
appropriate number of applications and total application rate.  If
additional field trial data are submitted, the request for the crop
group tolerance can be reevaluated.  In addition, HED stipulated in the
original review that the available mustard green magnitude of the
residue data would support a turnip, greens tolerance for residues of
fludioxonil of 10 ppm, provided that the petitioner agrees to increase
the PHI to 7 days and agrees to submit a mustard green field trial in
both Region 4 and Region 10 (PP#s: 2E6448, 2E6486, 2E6462, and 3E6526;
DP Num: 287808, 287810, 287812, and 287814; T. Bloem; 2/12/03).  The
requirement for additional data on mustard greens remains outstanding
(see Brassica vegetables, below).  

Sweet Potato 

IR-4 has submitted field trial data for fludioxonil on sweet potato. 
Two post-harvest sweet potato trials were conducted in the United States
encompassing Zones 2 (Clinton, NC; 1 trial) and 10 (Madera, CA; 1 trial)
during the 2004 growing season.  At each test location, sweet potatoes
were dipped for approximately 30 seconds in a solution of either Scholar
50WP at a rate of 0.5 lb ai/100 gal water or Fludioxonil 200SC at a rate
of 0.25 lb ai/100 gal water.  No adjuvant was added to the spray mixture
for all applications.  Following treatment, the potatoes were allowed to
dry out of the sunlight.  

Samples were analyzed for fludioxonil using the Syngenta Method AG-597B
with minor modifications.  The LOD and LOQ were calculated as 0.0057 ppm
and 0.017 ppm, respectively.  The analytical method has been found
suitable for data collection.  Residues of the chemical were shown to be
stable for the duration of storage that occurred during the conduct of
this study.  The results from these trials show that maximum fludioxonil
residue was 2.81 ppm after a post-harvest dip application at 0.5 lb
ai/100 gal water.  The maximum fludioxonil residue was 2.17 ppm after a
post-harvest dip application at 0.25 lb ai/100 gal water.

Conclusions:  There is adequate number and geographic location of
residue field trials to support a tolerance registration on sweet
potato.  Since sweet potato is the representative crop, the data are
adequate to support a tolerance on the tuberous and corm vegetables
(except potato) subgroup.  However, the MRL spreadsheet (see attached)
indicates that the requested tolerances are not appropriate.  The data
for the highest application rate were analyzed and the result, 3.5 ppm,
is the appropriate tolerance level.  In addition, the commodity
definition is incorrect.  A revised Section F is required for the
residues of fludioxonil on vegetable, tuberous and corm (except potato),
subgroup 1D at 3.5 ppm.

Tomato

IR-4 has submitted field trial data for fludioxonil on tomato.  Eighteen
trials were conducted in the 2002-growing season, 14 in the field and 4
in greenhouses.  The field trials were conducted in Maryland, New York,
Florida (2), North Carolina, California (5) New Mexico (2), Washington,
and Wisconsin.  The greenhouse trials were conducted in New Jersey,
Texas, Tennessee, and Colorado.  The total number of field trials was in
accordance with OPPTS Guideline 860.1500.  At each trial, tomato was
treated with four foliar applications of Switch 62.5 WG at the
approximate rate of 0.22 lb fludioxonil/A for a total of approximately
0.88 lb ai/A.  The foliar applications were made at 6 to 22-day
intervals.  The test substance was mixed with water without any
adjuvant.  Marketable tomato samples were collected on the day of the
final application. 

Samples were analyzed for residues of fludioxonil using an HPLC/UV
method based on Syngenta Method AG-597B, which was adequately validated
in conjunction with the field sample analyses.  In this study, the LLMV
was 0.02 ppm for fludioxonil.  The maximum storage interval for field
treated RAC samples was 343 days.  The results of a freezer storage
stability study demonstrated that fludioxonil residues were stable in
tomato RAC samples stored frozen for up to 475 days.  Analytical results
show that with a 0-day PHI, fludioxonil residues ranged from 0.014 to
0.229 ppm in treated tomato RAC samples grown in the field, and from
0.010 to 0.169 ppm in treated tomato RAC samples grown in a greenhouse.

Conclusions:  There is adequate number and geographic location of
residue field trials to support a tolerance registration on tomato.  In
addition, the petitioner has requested that the data be sued to support
the use on tomatillo.  Since the proposed uses are the same and these
two fruiting vegetable crops can be similar in size, the tomato data
will also support a tolerance on tomatillo.  The results of the MRL
spreadsheet (see attached) indicate that the requested tolerances are
appropriate.  ARIA recommends for the requested tolerances of
fludioxonil on tomato and tomatillo at 0.40 ppm.

However, since having the US tolerance lower than the Codex MRL would
cause a barrier to tomato imports, the tomato and tomatillo tolerances
should be raised from 0.40 ppm to 0.50 ppm.  A revised Section F should
be submitted for the tolerances of 0.50 ppm on tomato and tomatillo.

Brassica Vegetables

IR-4 submitted residue data for fludioxonil from field trials conducted
during 2004-2005 on selected Brassica vegetable crops, including five
cabbage field trials conducted in Zones 1, 2, 3, 5, and 10, and a one
field trial each on mustard greens and broccoli in Zone 10.  The end-use
product used in these trials was a multiple active ingredient, WDG
formulation, containing 25% fludioxonil and 37.5% cyprodinil.  In each
test, fludioxonil (25% WDG) was applied to cabbage, mustard greens, or
broccoli as four broadcast or directed foliar applications at rates of
0.22-0.24 lb ai/A and RTIs of 4-28 days, for a total of 0.88-0.93 lb
ai/A/season.  Applications were made using ground equipment in volumes
of 24-59 gal/A, and did not include the use of any spray adjuvants. 
Duplicate control and treated samples of mature cabbage (with wrapper
leaves), mustard greens, and broccoli were collected from the field
sites at 6-8 days DAT.  Cabbage, mustard greens, and broccoli samples
were stored frozen for up to 181, 65, and 176 days, respectively, prior
to extraction for analysis.  These storage intervals are supported by
available storage stability data.

Residues of fludioxonil in/on cabbage, broccoli and mustard greens were
determined using an HPLC/UV method (Method AG-597B), which was
adequately validated in conjunction with the analysis of field trial
samples.  For this method, residues are extracted with ACN:water,
concentrated, and partitioned into MTBE.  Residues were then cleaned up
using silica and phenyl SPE cartridges, and analyzed by HPLC/UV using a
normal-phase amino column.  The LLMV for fludioxonil residues is 0.02
ppm in/on each crop.  The statistically calculated LOQ was 0.014 ppm,
and the calculated LOD was 0.005 ppm.

Following four foliar applications totaling 0.88-0.93 lb ai/A,
fludioxonil residues were 0.06-1.11 ppm in/on 10 cabbage samples at 6-8
DAT, 1.01 and 1.04 ppm in/on two samples of mustard greens at 8 DAT, and
0.11 and 0.14 ppm in/on two samples of broccoli at 8 DAT.  Average
fludioxonil residues at 6-8 DAT were 0.34 ppm for cabbage, 1.03 ppm for
mustard greens, and 0.13 ppm for broccoli.

Conclusions:  As a condition for the registration of fludioxonil on
Brassica vegetables (Switch™ 62.5 WG; EPA Reg. No. 100-953), HED
required additional residue data from 5 field trials on cabbage, two
field trials on mustard greens, and one trial broccoli (DP# 287808, T.
Bloem, 2/12/2003).  Since the data for cabbage and broccoli were
produced with the appropriate use pattern, were of sufficient number and
correct locations as required by HED, and did not exceed the established
tolerance, ARIA concludes that the condition of registration for
fludioxonil on the Brassica, head and stem, subgroup 5A (Switch™ 62.5
WG; EPA Reg. No. 100-953) may be removed. 

	HED indicated that two trials on mustard greens were required as a
condition of registration: one each in Region 4 and 10.  The data for
mustard greens produced in Region 10 were generated with the appropriate
use pattern and did not exceed the established Brassica leafy greens,
subgroup 5B.  However, no mustard green field trial was conducted in
Region 4 as required.  Since the previously submitted data ranged so
widely, from 0.06-7.74 ppm for mustard greens treated at the 1x rate
with the single trial submitted here in that range, the additional trial
would likely have an affect on the final tolerance level.  Therefore,
ARIA recommends that the conditional registration not be removed and a
required mustard green field trial study in Region 4 remains
outstanding.

Table 6.  Summary of Residues from the Crop Field Trials with
Fludioxonil.

Crop Matrix	

Applic. Rate

(lb ai/A)	

PHI (days)	

Residues (ppm)

	Min.	Max.	HAFT1	Median	Mean	Std. Dev.

Avocado (proposed use = 0.88 lb ai/A total application rate, 0-day PHI)

RAC	

0.869-0.888	

0	0.0074	0.19	0.185	0.06	0.07	0.06

Cucurbit (proposed use = 0.22 lb ai/A total application rate, 1-day PHI)

Cantaloupe	0.857-0.927	1	0.02	0.52	0.36	0.12	0.15	0.129

7-8	0.01	0.19	0.15	0.04	0.07	0.063

Cucumber	0.857-0.927	1	0.01	0.13	0.13	0.05	0.06	0.039

7-8	<0.01	0.08	0.05	0.01	0.015	0.011

Squash	0.857-0.927	1	0.01	0.08	0.08	0.04	0.044	0.026

6-7	<0.01	0.03	0.025	0.01	0.013	0.007

Lemon (proposed use = 0.22 lb ai/A total application rate, 0-day PHI)

RAC	0.219	0	0.11	0.19	0.16	0.135	0.138	0.030

Parsley (proposed use = 0.88 lb ai/A total application rate, 7-day PHI)

Fresh Parsley	0.870-0.876	6-7	0.96	3.87	3.59	2.56	2.50	0.97

Dried Parsley

	8.87	22.29	-	16.86	16.22	5.69

Carrot (proposed use = 0.88 lb ai/A total application rate, 7-day PHI)

RAC	0.90	0	0.35	0.45	0.40	0.40	0.40	0.07

3	0.39	0.54	0.47	0.47	0.47	0.11

7	0.48	0.69	0.59	0.59	0.59	0.15

14	0.43	0.63	0.53	0.53	0.53	0.14

21	0.61	0.63	0.62	0.62	0.62	0.01

Radish (proposed use = 0.88 lb ai/A total application rate, 7-day PHI)

Radish Tops	0.427-0.470	7-8	0.42	11.3	10.12	5.86	4.41	3.23

Radish Roots

	0.008	0.13	0.105	0.069	0.06	0.04

Sweet Potato (proposed use = 0.50 lb ai, 0-day PHI)

Sweet potato	0.50	NA	2.23	2.81	2.52	2.44	2.48	0.24

	0.25	NA	1.19	2.17	1.98	1.71	1.70	0.41

Tomato (proposed use = 0.88 lb ai/A total application rate, 0-day PHI)

All RAC	0.866-0.904	0	0.010	0.229	0.2235	0.08	0.10	0.07

3	0.0320	0.158	0.1196	0.06	0.08	0.06

7	0.0399	0.105	0.0853	0.06	0.06	0.03

14	0.0293	0.0995	0.0814	0.05	0.06	0.03

RAC Field	0.866-0.902	0	0.014	0.229	0.2235	0.08	0.10	0.07

3	0.0320	0.0324	0.0322	0.03	0.03	0.0003

7	0.0399	0.0456	0.0428	0.04	0.04	0.004

14	0.0293	0.0317	0.0305	0.03	0.03	0.002

RAC Greenhouse 	0.871-0.904	0	0.010	0.169	0.1505	0.12	0.10	0.06

3	0.0811	0.158	0.1196	0.12	0.12	0.05

7	0.105	0.0656	0.0853	0.08	0.08	0.03

14	0.0633	0.0995	0.0814	0.08	0.08	0.02

RAC Unwashed 	0.866-0.904	0	0.0234	0.229	0.2235	0.09	0.11	0.06

RAC Washed	0.867-0.890	0	0.010	0.016	0.015	0.013	0.013	0.003

Brassica Vegetables (proposed use = 0.88 lb ai/A total application rate,
7-day PHI)

Cabbage	0.88-0.93	6-8	0.06	1.11	0.99	0.21	0.34	0.37

Mustard greens	0.88	8	1.01	1.04	1.03	1.03	1.03	0.02

Broccoli	0.88	8	0.11	0.14	0.13	0.13	0.13	0.02

1HAFT = Highest Average Field Trial

860.1520 Processed Food and Feed

DER 47161101, W. Cutchin, in process

D292567, MRID: 46162301, L. Jones, 8/17/04

	The only RACs associated with these petitions have processed
commodities of regulatory interest are lemon, lime, and tomato.

Citrus

	No citrus processing studies were submitted with this petition. 
Previous studies conducted in conjunction with a post-harvest use
(D292567, MRID: 46162301, L. Jones, 8/17/04) indicated that in citrus
processed commodities fludioxonil residues concentrate only on citrus
oil at 61x and on pulp at 2.1x.  Since the HAFT for lemons in the
submitted studies was 0.16 ppm, the expected residues on citrus oil from
this use at 9.76 ppm (0.16 ppm x 61) will not exceed the existing
tolerance on citrus fruit and would be considerably lower than the
existing tolerance on grapefruit oil at 500 ppm.  Similarly, the
expected residues on citrus pulp as a result of the proposed use at 0.37
ppm (0.16 ppm x 2.1) will also not exceed the existing tolerance on
citrus fruit at 10 ppm.  No change in tolerances is required as a result
of the proposed use on lemon and lime.  

Tomato 

Switch 62.5 WG, a 25% water-dispersible granule formulation of
fludioxonil was applied to tomato at the approximate rate of 0.219 lb
fludioxonil/A for a total of approximately 0.88 lb ai/A, and harvested
at a pre-harvest interval (PHI) of 0-days after final treatment.  Tomato
RAC samples were processed into puree and paste.  Samples were analyzed
for residues of fludioxonil using HPLC/UV method (based on Syngenta
Method AG-597B), which was adequately validated in conjunction with the
field sample analyses.  The maximum storage interval for field treated
samples was 343 days (RAC), 292 days (puree), and 288 days (paste).  The
results of a freezer storage stability study demonstrated that
fludioxonil residues were stable in tomato samples stored frozen for up
to 475 days (RAC), 337 days (puree), and 330 days (paste).  A comparison
of fludioxonil residues in tomato RAC with those in each processed
fraction resulted in reduced residues in puree by a factor of 0.3x.  In
paste samples, fludioxonil residues were concentrated by factor of 1.1x.
 These concentration factors are less than the theoretical concentration
factor (5x for tomato).

Conclusions:  The submitted tomato processing study indicates that
fludioxonil residues do not appreciably concentrate in tomato processed
commodities made from treated tomato samples; therefore, tolerances are
not required for tomato processed commodities.

860.1650 Submittal of Analytical Reference Standards

Adequate analytical reference standards have been submitted to the
Agency’s Pesticide Repository (97.3% purity, lot # 422949, expiration
date 5/1/08).

860.1850 and 860.1900 Confined and Field Accumulation in Rotational
Crops

D262022, W. Donovan, 1/18/00

D258865, W. Donovan, 12/17/99

	HED has reviewed a confined rotational crop study conducted with
[14C-phenyl]-fludioxonil and concluded that the residue of concern in
rotational crops is only fludioxonil (D262022, W. Donovan, 1/18/00). 
Since the TRRs were >0.01 ppm in/on all crops and rotational intervals,
the petitioner submitted and HED reviewed a limited field rotational
crop study.

		Fludioxonil (50% WP formulation) was applied four times (RTI of 7
days) as a broadcast spray to bare soil at 0.25 lbs ai/A for a total
application rate of 1.00 lbs ai/A (1.1x the seasonal application rate
for the all currently requested crops).  The plots were planted with
leaf lettuce, turnips, and wheat 27-32 days after the final treatment. 
Lettuce and turnip (root and top) samples were collected at maturity. 
Wheat forage was sampled between the 6-8” stage and jointing stage
(62-259 days after planting).  Wheat hay was cut between the boot and
soft dough stage (101-316 days after planting).  Wheat grain and straw
samples were collected at maturity.  Residues of fludioxonil were
nondetectable (<0.01 ppm) in/on all of the harvested samples (D258865,
W. Donovan, 12/17/99). 

	The proposed label indicates that only those crops listed on the label
may be rotated to a treated field at 0-day following treatment and all
other crops may be planted after 30 days.  Based on the results of the
confined and field rotational crop studies and the proposed application
rates, the label rotational crop restrictions are acceptable.     

860.1550 Proposed Tolerances

Tolerances are established on the plants in terms of parent fludioxonil
[(4-(2,2-difluoro-1,3-benzodioxol-4-yl)-1H-pyrrole-3-carbonitrile] as
determined by HED.  Numerous commodities have established fludioxonil
tolerances as shown in CFR §180.516.  There are no Canadian or Mexican
Maximum Residue Limits (MRLs) for residues of fludioxonil.  There are
Codex limits on tomato (higher than US; 0.5 ppm vs 0.40 ppm, proposed),
herbs (equal to or lower than US), cucurbits (lower than US), and carrot
(lower than US).   None of the items are significant US export items. 
Except for tomato, the Codex MRLs are not a restriction on items for
which there is a significant import trade; therefore, there are no
international harmonization issues with these items.  Since having the
US tolerance lower than the Codex MRL would cause a barrier to tomato
imports, the tomato and tomatillo tolerances should be raised from 0.40
ppm to 0.50 ppm.  A revised Section F should be submitted for the
tolerances of 0.50 ppm on tomato and tomatillo.

Table 7.  Tolerance Summary for Fludioxonil

Commodity	

Established/Proposed Tolerance (ppm)	

Recommended Tolerance (ppm)	

Comments (correct commodity definition)

Tomato	0.40	0.50	Raised for harmonization issues

Tomatillo	0.4	0.50	Raised for harmonization issues

Tomato, paste	1.0	None

	Avocado 		0.45	0.45

	Black sapote 		0.45	0.45

	Canistel	0.45	0.45

	Mamey sapote	0.45	0.45

	Mango 	0.45	0.45

	Papaya 	0.45	0.45

	Sapodilla 	0.45	0.45

	Star apple 		0.45	0.45

	Herb Subgroup 19A, fresh 			13 (Requested)

10 (Established)	10	Retain Established Tolerance

Herb Subgroup 19A, dried 			55 (Requested)

65 (Established)	65	Retain Established Tolerance

Leaves of root and tuber vegetables	40 (Requested)

0.02 (Established)	30	Leaves of root and tuber vegetables, group 2

Root vegetables, except sugar beet subgroup	0.50	0.75	root vegetables,
(except sugar beet), subgroup 1B

Lemon 	0.25	None

	Lime 	0.25	None

	Cucurbits 	0.60	0.45	vegetable, cucurbit, group 9 

Tuberous and corm vegetables, except 

potato subgroup	4.0	3.5	vegetable, tuberous and corm (except potato),
subgroup 1D 

Carrot 	0.75	None	Remove Established Tolerance

Turnip, greens 	10	None	Remove Established Tolerance

Citrus oil	None	500

	Grapefruit oil	500	None	Remove Established Tolerance

Template Version November 2003

 Attachment 1: Chemical Structures

Common Code 	

Chemical name	

Chemical structure

CGA 173506	

4-(2,2-difluoro-1,3-benzodioxol-4-yl)-1H-pyrrole-3- carbonitrile	

 

CGA 344623	

4-(2,2-difluoro-1,3-benzdioxol-4-yl)-2,5-dioxo-3-pyrrolidine carboxylic
acid	

 

I-1	

4-(2,2-difluoro-1,3-benzodioxol-4-yl)-pyrrole-3- carbonitrile,
1-O-sulfate ester	

 

B-1	

4-(2,2-difluoro-1,3-benzodioxol-4-yl)-1H-pyrrole-3- carbonitrile,
2-O-glucose	

 

CGA 344623 – or O-glucose conjugate	

	

 

 

CGA 173506 lactic acid conjugate	

	

 

Attachment 2. International Harmonization

INTERNATIONAL RESIDUE LIMIT STATUS

	Chemical Name:

(4-(2,2-difluoro-1,3-benzodioxol-4-yl)-1H-pyrrole-3-carbonitrile

	Common Name:

Fludioxonil 	x Proposed tolerance

 Reevaluated tolerance

 Other	Date: 4/4/08

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: 7E7234 & 2E6462

DP#s: 345970 & 349725

Other Identifier:

	Residue definition (step 8/CXL):  Plant commodities: fludioxonil
Reviewer/Branch: W. Cutchin

Residue definition: Fludioxonil
(4-(2,2-difluoro-1,3-benzodioxol-4-yl)-1H-pyrrole-3-carbonitrile

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

Tomato	0.5	Tomato	0.40

Tomatillo	0.4

Tomato, paste	1.0

Avocado 	0.45

Black sapote 	0.45

Canistel	0.45

Mamey sapote	0.45

Mango 	0.45

Papaya 	0.45

Sapodilla 	0.45

Star apple 	0.45

Basil	10	Herb Subgroup 19A, fresh 	10

Basil, dry	50	Herb Subgroup 19A, dried 	65 

Chives	10

Chives, dry	50

Leaves of root and tuber vegetables	40 

Root vegetables, except sugar beet subgroup	0.50

Citrus fruits	7	Lemon 	0.25

Citrus fruits	7	Lime 	0.25

Cucumber 

	0.3

 No Limits

 No Limits for the crops requested	 No Limits

 No Limits for the crops requested

	Residue. 

4-(2,2-difluoro-1,3-benzodioxol-4-yl) 1Hpyrrole-

3-carbonitrile

	Residue definition: 

fludioxonil

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

	Notes/Special Instructions:  S.Funk, 04/08/2008.

	

Attachment 3.  MRL Spreadsheets

MRL Spread Sheets

Avocado

Regulator:	EPA

Chemical:	Fludox

Crop:	Avocad

PHI:	0 days

App. Rate:

	Submitter:

	0.05

	0.0164

	0.02

	0.18

	0.11

	0.0164

	0.08

	0.02

	0.07

	0.19

	0.11

	0.04

Cucurbit – Cantaloupe

Cucurbit – Cucumber

Cucurbit – Squash

Lemon

Parsley Fresh

Regulator:	EPA

Chemical:	Fludox

Crop:	Pars Fr

PHI:	6-7 days

App. Rate:

	Submitter:

Residues

	2.28

	0.96

	3.3

	3.15

	1.98

	1.62

	3.87

	2.84

Parsley Dried

Chive (DER 45795302, T. Bloem, 2/12/03)

 

Basil (DER 45795301, T. Bloem, 2/12/03)

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Submitter:

Residues

	10.76

	13.06

	1.77

	2

	2.68

	3.42

Radish Root

Regulator:	EPA

Chemical:	Fludox

Crop:	Rad root

PHI:	7-8 day

App. Rate:

	Submitter:

Residues

	0.08

	0.13

	0.07

	0.02

	0.11

	0.1

	0.07

	0.08

	0.01

	0.018

	0.01

	0.01

Radish Tops

Regulator:	EPA

Chemical:	Fludox

Crop:	Rad top

PHI:	7-8 day

App. Rate:

	Submitter:

Residues

	4.59

	4.5

	5.84

	5.8

	8.94

	11.3

	2.86

	3.22

	2.16

	2.79

	0.42

	0.47

Mustard Greens (DER 45726102, T. Bloem, 2/12/03 and DER 47169311, W.
Cutchin, in process)

Regulator:	EPA

Chemical:	Fludox

Crop:	Must Gr

PHI:	6-8 day

App. Rate:

	Submitter:

Residues

	7.740

	6.53

	0.45

	0.64

	6.92

	6.43

	0.06

	0.06

	0.48

	0.5

	1.23

	0.33

	1.06

	1.280

	1.040

	1.010

Sweet Potato

Regulator:	EPA

Chemical:	Fludox

Crop:	SPot-0.5

PHI:	0-day

App. Rate:

	Submitter:

Residues

	2.4

	2.49

	2.23

	2.81

Tomato

Regulator:	EPA

Chemical:	Fludox

Crop:	Tomato

PHI:	0-day

App. Rate:

	Submitter:

Residues

	0.0529

	0.0775

	0.105

	0.218

	0.0659

	0.115

	0.132

	0.14

	0.208

	0.0593

	0.199

	0.0517

	0.0342

	0.0489

	0.041

	0.136

	0.109

	0.141

	0.0312

	0.0897

	0.155

	0.229

	0.0881

	0.0773

	0.0799

	0.208

	0.167

	0.185

	0.0376

	0.0234

	0.0304

	0.0661

	0.165

	0.156

	0.0749

Fludioxonil	Summary of Analytical Chemistry and Residue Data	DP Num:
345970

Concentrations

Percentiles

tion Labels

-

Concentra

Labels

Percentile 

days  

Chive 7-8 

Fludox 

for EPA 

gression 

-

Linear re

days  

Chive 7-8 

EPA Fludox 

Lognormal Probability Plot

-0.47

-0.47

-0.47

-0.47

-0.47

-0.47

-0.47

-0.47

-0.47

-0.47

-0.47

-0.47

-0.47

-0.47

-0.47

-0.47

-0.47

-0.47

-0.47

-0.47

-0.47

-0.47

-0.47

-0.47

-0.47

-0.47

-0.47

-0.47

0.22

0.92

1.61

 

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of  NUMPAGES \*Arabic  55