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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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

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of  NUMPAGES \*Arabic  55


[Federal Register Volume 85, Number 246 (Tuesday, December 22, 2020)]
[Rules and Regulations]
[Pages 83448-83450]
[FR Doc No: 2020-28161]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket Number USCG-2020-0716]
RIN 1625-AA00

Safety Zone; Pipeline Testing; Tampa Bay, Gibsonton, FL

AGENCY: Coast Guard, DHS.

ACTION: Temporary final rule.

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SUMMARY: The Coast Guard is establishing a temporary safety zone for
certain waters in the navigable waters of Tampa Bay, Gibsonton, FL. The
safety zone is needed to protect personnel, vessels, and the marine
environment from potential hazards created by pipeline pressure testing
in the area. Entry of vessels or persons into this zone is prohibited
unless specifically authorized by the Captain of the Port St.
Petersburg.

DATES: This rule is effective from 12:01 a.m. on January 1, 2021,
through 7:00 a.m. on January 4, 2021.

ADDRESSES: To view documents mentioned in this preamble as being
available in the docket, go to https://www.regulations.gov, type USCG-
2020-0716 in the ``SEARCH'' box and click ``SEARCH.'' Click on Open
Docket Folder on the line associated with this rule.

FOR FURTHER INFORMATION CONTACT: If you have questions on this rule,
call or email Marine Science Technician First Class Michael D.
Shackleford, Sector St. Petersburg Prevention Department, Coast Guard;
telephone<PHONE_NUMBER>, email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Table of Abbreviations

CFR Code of Federal Regulations
DHS Department of Homeland Security
FR Federal Register
NPRM Notice of proposed rulemaking
Sec.  Section
U.S.C. United States Code

II. Background Information and Regulatory History

    The Coast Guard is issuing this temporary rule without prior notice
and opportunity to comment pursuant to authority under section 4(a) of
the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This
provision authorizes an agency to issue a rule without prior notice and
opportunity to comment when the agency for good cause finds that those
procedures are ``impracticable, unnecessary, or contrary to the public
interest.'' Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good
cause exists for not publishing a notice of proposed rulemaking (NPRM)
with respect to this rule because it would be impracticable. The Coast
Guard was unable to publish an NPRM and hold a comment period for this
rulemaking due to the short time period the Captain of the Port St.
Petersburg (COTP) was notified of the need for the safety zone. It is
necessary for the Coast Guard to establish this safety zone by January
1, 2021, in order to ensure the appropriate level of protection exists
in order to mitigate the potential safety hazards associated with
pipeline pressure testing in the event of an explosion.
    Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause
exists for making this rule effective less than 30 days after
publication in the Federal Register. Delaying the effective date of
this rule for the same reasons stated in the preceding paragraph.

III. Legal Authority and Need for Rule

    The Coast Guard is issuing this rule under authority in 46 U.S.C.
70034. The COTP has determined that potential hazards associated with
pipeline pressure testing starting January 1, 2021 will be a safety
concern for anyone within this safety zone in the event of an
explosion. This rule is needed to protect personnel, vessels, and the
marine environment in the navigable waters within the safety zone while
the testing is occuring.

IV. Discussion of the Rule

    This rule establishes a safety zone from 12:00 a.m. on January 1,
2021, until 7:00 a.m. on January 4, 2021. The safety zone will cover
all navigable waters of Tampa Bay, east of a line formed by connecting
the points of 27[deg]48'9'' N, 082[deg]24'56'' W and 27[deg]48'0'' N,
082[deg]24'56'' W. The duration of the zone is intended to protect
personnel, vessels, and the marine environment in these navigable
waters while pipeline pressure testing is occuring. No vessel or person
will be permitted to enter the safety zone without obtaining permission
from the COTP or a designated representative.

V. Regulatory Analyses

    We developed this rule after considering numerous statutes and
Executive orders related to rulemaking. Below we summarize our analyses
based on a number of these statutes and Executive orders, and we
discuss First Amendment rights of protestors.

A. Regulatory Planning and Review

    Executive Orders 12866 and 13563 direct agencies to assess the
costs and benefits of available regulatory alternatives and, if
regulation is necessary, to select regulatory approaches that maximize
net benefits. Executive Order 13771 directs agencies to control
regulatory costs through a budgeting process. This rule has not been
designated a ``significant regulatory action,'' under Executive Order
12866. Accordingly, this rule has not been reviewed by the Office of
Management and Budget (OMB), and pursuant to OMB guidance it is exempt
from the requirements of Executive Order 13771.
    This regulatory action determination is based on the size,
location, duration, and time-of-day of the safety zone. This area of
Tampa Bay is not in a critical navigation area.

B. Impact on Small Entities

    The Regulatory Flexibility Act of 1980, 5 U.S.C. 601-612, as
amended, requires Federal agencies to consider the potential impact of
regulations on small entities during rulemaking. The term ``small
entities'' comprises small businesses, not-for-profit organizations
that are independently owned and operated and are not dominant in their
fields, and governmental jurisdictions with populations of less than
50,000. The Coast Guard certifies under 5 U.S.C. 605(b) that this rule
will not have a significant economic impact on a substantial number of
small entities.
    While some owners or operators of vessels intending to transit the
safety zone may be small entities, for the reasons stated in section
V.A above, this rule will not have a significant economic impact on any
vessel owner or operator.
    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104-121), we want to assist small
entities in understanding this rule. If the rule would affect your
small business, organization, or governmental jurisdiction and you have
questions concerning its provisions or options for compliance, please
call or email the person listed in the FOR FURTHER INFORMATION CONTACT
section.
    Small businesses may send comments on the actions of Federal
employees who enforce, or otherwise determine compliance with, Federal
regulations to the Small Business and Agriculture Regulatory
Enforcement Ombudsman and the Regional Small Business Regulatory
Fairness Boards. The Ombudsman evaluates these actions annually and
rates each agency's responsiveness to small business. If you wish to
comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR
(1-888-734-3247). The Coast Guard will not retaliate against small
entities that question or complain about this rule or any policy or
action of the Coast Guard.

C. Collection of Information

    This rule will not call for a new collection of information under
the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

D. Federalism and Indian Tribal Governments

    A rule has implications for federalism under Executive Order 13132,
Federalism, if it has a substantial direct effect on the States, on the
relationship between the National Government and the States, or on the
distribution of power and responsibilities among the various levels of
government. We have analyzed this rule under that Order and have
determined that it is consistent with the fundamental federalism
principles and preemption requirements described in Executive Order
13132.
    Also, this rule does not have tribal implications under Executive
Order 13175, Consultation and Coordination with Indian Tribal
Governments, because it does not have a substantial direct effect on
one or more Indian tribes, on the relationship between the Federal
Government and Indian tribes, or on the distribution of power and
responsibilities between the Federal Government and Indian tribes.

E. Unfunded Mandates Reform Act

    The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538)
requires Federal agencies to assess the effects of their discretionary
regulatory actions. In particular, the Act addresses actions that may
result in the expenditure by a State, local, or tribal government, in
the aggregate, or by the private sector of $100,000,000 (adjusted for
inflation) or more in any one year. Though this rule will not result in
such an expenditure, we do discuss the effects of this rule elsewhere
in this preamble.

F. Environment

    We have analyzed this rule under Department of Homeland Security
Directive 023-01, Rev. 1, associated implementing instructions, and
Environmental Planning COMDTINST 5090.1 (series), which guide the Coast
Guard in complying with the National Environmental Policy Act of 1969
(42 U.S.C. 4321-4370f), and have determined that this action is one of
a category of actions that do not individually or cumulatively have a
significant effect on the human environment. This rule involves a
safety zone lasting approximately 4 days that will prohibit entry to
all navigable waters of Tampa Bay, east of a line formed by connecting
the points of 27[deg]48'9'' N, 082[deg]24'56'' W and 27[deg]48'0'' N,
082[deg]24'56'' W. It is categorically excluded from further review
under paragraph L60 of Appendix A, Table 1 of DHS Instruction Manual
023-01-001-01, Rev. 1. A Memorandum for Record supporting this
determination is available in the docket. For instructions on locating
the docket, see the ADDRESSES section of this preamble.

G. Protest Activities

    The Coast Guard respects the First Amendment rights of protesters.
Protesters are asked to call or email the person listed in the FOR
FURTHER INFORMATION CONTACT section to coordinate protest activities so
that your message can be received without jeopardizing the safety or
security of people, places or vessels.

List of Subjects in 33 CFR Part 165

    Harbors, Marine safety, Navigation (water), Reporting and
recordkeeping requirements, Security measures, Waterways.

    For the reasons discussed in the preamble, the Coast Guard amends
33 CFR part 165 as follows:

PART 165--SAFETY ZONE; PIPELINE TESTING; TAMPA BAY, GIBSONTON, FL

0
1. The authority citation for part 165 continues to read as follows:

    Authority: 46 U.S.C. 70034; 46 U.S.C. 70051; 33 CFR 1.05-1,
6.04-1, 6.04-6, and 160.5; Department of Homeland Security
Delegation No. 0170.1.

0
2. Add Sec.  165.T07-0716 to read as follows:

Sec.  165.T07-0716   Safety Zone; Pipeline Testing; Tampa Bay,
Gibsonton, FL.

    (a) Location. The following regulated area is a safety zone: All
navigable waters of Tampa Bay, east of a line formed by connecting the
points of 27[deg]48'9'' N, 082[deg]24'56'' W and 27[deg]48'0'' N,
082[deg]24'56'' W in the vicinity of Gibsonton, Florida.
    (b) Definition. The term ``designated representative'' means Coast
Guard Patrol Commanders, including Coast Guard coxswains, petty
officers, and other officers operating Coast Guard vessels, and
Federal, state, and local officers designated by or assisting the

Captain of the Port St. Petersburg in the enforcement of the regulated
area.
    (c) Regulations. (1) All persons and vessels are prohibited from
entering, transiting through, anchoring in, or remaining within the
regulated area unless authorized by the Captain of the Port St.
Petersburg or a designated representative.
    (2) Designated representatives may control vessel traffic
throughout the enforcement area as determined by the prevailing
conditions.
    (3) Persons and vessels may request authorization to enter, transit
through, anchor in, or remain within the regulated areas by contacting
the Captain of the Port St. Petersburg by telephone at<PHONE_NUMBER>,
or a designated representative via VHF radio on channel 16. If
authorization is granted by the Captain of the Port St. Petersburg or a
designated representative, all persons and vessels receiving such
authorization must comply with the instructions of the Captain of the
Port St. Petersburg or a designated representative.
    (d) Enforcement period. This rule will be enforced daily from 12:01
a.m. on January 1, 2021, through 7:00 a.m. on January 4, 2021.

    Dated: December 16, 2020.
Matthew A. Thompson,
Captain, U.S. Coast Guard, Captain of the Port St. Petersburg.
[FR Doc. 2020-28161 Filed 12-21-20; 8:45 am]
BILLING CODE 9110-04-P