Document ID: EPA-HQ-OPP-2009-0644-0007
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2012-11-28T05:00Z

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
                               WASHINGTON, D.C.  20460
                                       
	OFFICE of CHEMICAL SAFETY
	and POLLUTION PREVENTION
                                                                               

MEMORANDUM

Date:  		7/24/2012

SUBJECT:	Fenpropathrin.  Request for Tolerances in Support of New Uses on the Tropical Fruits Guava, Acerola, Feijoa, Jaboticaba, Passionfruit, Starfruit, Wax Jambu, Lychee, Longan, Spanish Lime, Pulasan, Rambutan, Sugar Apple, Atemoya, Biriba, Cherimoya, Custard Apple, Ilama, and Soursop.  Request for a Tolerance Without U.S. Registration on Tea.  Summary of Analytical Chemistry and Residue Data.

PC Code:  127901
DP Barcode:  D368340
Decision No.: 417627
Registration No.:  59639-35
Petition No.:  9E7594
Regulatory Action:  Amended Section 3
Risk Assessment Type:  NA
Case No.:  NA
TXR No.:  NA
CAS No.:  39515-41-8
MRID Nos.:  47813101, 47813102  
40 CFR:  180.466
	

FROM:	Douglas Dotson, Ph.D., Chemist
		Risk Assessment Branch II
		Health Effects Division		

THROUGH:	Dennis McNeilly, Chemist
      Risk Assessment Branch II
		Health Effects Division		
		
TO:		Laura Nollen/Barbara Madden, RM Team 5 
      RIMUERB
		Registration Division (7505P)		

Executive Summary

Fenpropathrin (alpha-cyano-3-phenoxy-benzyl 2,2,3,3-tetramethylcyclopropanecarboxylate) is an ingestion and contact pyrethroid insecticide and acaricide currently registered for use on fruits, vegetables, field crops, and ornamental plants for the control of various insect pests and mites.  

Under PP#9E7594, the Interregional Research Project Number 4 (IR-4) proposed the establishment of permanent tolerances for the combined residues of fenpropathrin in/on the following raw agricultural commodities:

            Guava	1.5 ppm
            Acerola	1.5 ppm
            Feijoa	1.5 ppm
            Jaboticaba	1.5 ppm
            Passionfruit	1.5 ppm
            Starfruit	1.5 ppm
            Wax jambu	1.5 ppm
            Lychee	3.0 ppm
            Longan	3.0 ppm
            Spanish lime	3.0 ppm
            Pulasan	3.0 ppm
            Rambutan 	3.0 ppm
            Sugar apple	1.0 ppm
            Atemoya	1.0 ppm
            Biriba	1.0 ppm
            Cherimoya	1.0 ppm
            Custard apple	1.0 ppm
            Ilama	1.0 ppm
            Soursop	1.0 ppm
            Tea	2.0 ppm

In conjunction with this petition, IR-4 is requesting amended registration of the Valent U.S.A. Corporation end-use product, Danitol(R) 2.4 EC Spray (EPA Reg. No. 59639-35), a 2.4 lb/gal emulsifiable concentrate (EC) formulation, to add new uses on the tropical fruits listed above.  No domestic use on tea has been proposed.  The 2.4 lb/gal EC formulation is proposed for foliar application to tropical and subtropical fruits as up to two foliar applications at 0.3-0.4 lb ai/A/application for a maximum seasonal rate of 0.8 lb ai/A.  A minimum retreatment interval of 14 days and a 1-day preharvest interval (PHI) are proposed.  The 2.4 lb/gal EC formulation is currently registered for use on tropical and subtropical fruits with inedible peel, including avocado, canistel, mango, papaya, sapodilla, sapote (black, mamey), and star apple.  The proposed new use directions for tropical and subtropical fruit listed above are identical to the registered uses on tropical and subtropical fruit with inedible peel, except that the minimum spray volume for ground applications has been reduced from 100 gal/A to 75 gal/A.  

The field trials conducted in India that were submitted in support of the proposed tolerance for tea reflect a single broadcast foliar application of a 300 g/L (2.5 lb/gal) EC formulation of fenpropathrin at 0.029, 0.052, or 0.10 lb ai/A (0.032, 0.059, or 0.012 kg ai/ha).  Tea was harvested at 0- to 14-day PHIs.  The following Good Agricultural Practice (GAP) information for India was provided:  shoots along with bud are typically harvested at a 7-day PHI.  No GAP information was provided concerning application rate in India; however, the application rates of 0.052 and 0.10 lb ai/A were designated "normal dose" and "double dose."  No GAP information was provided for any countries other than India.  No U.S. uses are proposed at this time.  

Tolerances for residues of fenpropathrin are established under 40 CFR §180.466 and are expressed in terms of fenpropathrin.  Tolerances for crop commodities range from 0.01 ppm (peanut) to 75 ppm (citrus oil).  Tolerances for the tropical fruits avocado, canistel, mango, papaya, sapodilla, sapote (black, mamey), and star apple are established at 1.0 ppm.  Tolerances for livestock commodities range from 0.05 ppm (egg and the fat, meat, and meat byproducts of poultry) to 2.0 ppm (milk fat reflecting 0.08 ppm in whole milk).  In the previous risk assessment that was prepared for fenpropathrin (D313330, D. Dotson, 11/26/2008), HED recommended in favor of reassessed tolerances for cattle, goat, hog, horse, and sheep commodities.  HED recommended that the tolerance for the meat and meat byproducts of cattle, goats, horses, and sheep be reduced to 0.01 ppm.  HED recommended that the tolerance for the fat of these same commodities be reduced to 0.05 ppm.  HED recommended that the tolerance for milk fat be reduced to 0.05 ppm (reflecting 0.002 ppm in whole milk).  Finally, HED recommended that the tolerances for hog commodities (fat, meat, and meat byproducts) be removed.  The revisions have not been made to the 40CFR listing for fenpropathrin.  

The nature of the residue in plants is adequately understood based on acceptable metabolism studies conducted on apple, cotton, pinto beans, and tomatoes.  The residue of concern for tolerance enforcement is the parent compound.

There are no livestock feedstuffs associated with the proposed use on tropical fruits.  Therefore, no livestock metabolism data, enforcement methods, storage stability data, or feeding studies are required to support this petition.

An adequate gas chromatography method with electron capture detection (GC/ECD), Residue Method Number RM-22-4, is available for the enforcement of tolerances of fenpropathrin in crop commodities.  The limit of detection (LOD) is 0.01 ppm.  In addition, residues of fenpropathrin are completely recovered through Protocol D of the FDA multiresidue methods.  Samples of guava, lychee, sugar apple, and atemoya from the submitted tropical fruit field trials were analyzed using an adequate revised version of the enforcement method which uses GC with mass selective detection in the selected ion monitoring mode (MS-SIM).  The lower limit of method validation (LLMV) was 0.02 ppm for all matrices.  Samples of dried black tea leaves from the tea field trials were analyzed for residues of fenpropathrin using adequate GC/ECD methods.  

The submitted crop field trial studies are supported by adequate storage stability data.  

Adequate field trial data for guava, lychee, sugar apple, and atemoya were submitted to support the proposed uses on tropical fruits.  HED's Chemistry Science Advisory Council (ChemSAC) has approved the revision of 40 CFR §180.1(g) to reflect the commodity definitions for guava, lychee, and sugar apple.  The submitted crop field trial data for guava, lychee, and sugar apple may be translated to support the proposed uses on the corresponding specific commodities; however, a separate tolerance must be established for each commodity.  ChemSAC approved the following revisions:  (1) a tolerance for guava also applies to feijoa, jaboticaba, wax jambu, starfruit, passionfruit, and acerola; (2) a tolerance for lychee also applies to longan, Spanish lime, rambutan, and pulasan; and (3) a tolerance for sugar apple also applies to cherimoya, ilama, soursop, and biriba.  A tolerance for sugar apple already applies to atemoya and custard apple.  The submitted crop field trial data will support the proposed tolerances of 3.0 ppm for guava, acerola, feijoa, jaboticaba, passionfruit, starfruit, and wax jambu; 7.0 ppm for lychee, longan, Spanish lime, pulasan, and rambutan; and 1.5 ppm for sugar apple, atemoya, biriba, cherimoya, custard apple, ilama, and soursop.  The Organization for Economic Cooperation and Development Maximum Residue Limit (OECD MRL) calculation procedures were used to determine the recommend tolerances.    

Adequate field trial data reflecting use of fenpropathrin on tea grown in India are available for establishing an import tolerance on dried tea leaves.  The OECD MRL calculation procedures recommend that the tolerance be established at 3.0 ppm.  However, there is a Codex MRL of 2.0 ppm for dried tea.  As a result, HED recommends in favor of a 2.0 ppm for tea, dried in order to harmonize with the Codex MRL.  

HED does not require residue data for any processed commodity associated with the tropical fruits addressed herein, but does require residue data for the processed commodity, instant tea.  No residue data for instant tea were submitted.  The petitioner indicated that studies on transfer of fenpropathrin residues to brewed tea are available and indicate there is little transfer of fenpropathrin residues from dried tea leaves to brewed tea.  Because of the high octanol/water partition coefficient (5.1) and the low water solubility (0.33 ppm), an insignificant quantity of fenpropathrin would be expected to transfer from leaves to brewed tea.  As a result, a processing study is not needed.

Because the proposed tropical fruits are not rotated, no data pertaining to rotational crops are required to support this petition. 

No Codex, Canadian, or Mexican MRLs are established on the proposed tropical fruits.  As a result, harmonization of tolerances is not an issue for the tropical fruits.  A Codex MRL is established for residues of fenpropathrin in/on tea, green, black at 2 ppm.  Using the OECD MRL calculation procedures, the recommended tolerance for dried tea is 3.0 ppm.  For purposes of harmonization of the U.S. tolerance with the established Codex MRL, HED is recommending in favor of a tolerance of 2.0 ppm for dried tea.

Currently, tolerances are established for residues of the pesticide chemical fenpropathrin (alpha-cyano-3-phenoxy-benzyl 2,2,3,3-tetramethylcyclopropanecarboxylate) in or on the commodities in 40CFR §180.466.  This tolerance expression needs to be revised as follows:   "Tolerances are established for residues of fenpropathrin including its metabolites and degradates, in or on the commodities in the table below.  Compliance with the tolerance levels specified below is to be determined by measuring only fenpropathrin (alpha-cyano-3-phenoxy-benzyl 2,2,3,3-tetramethylcyclopropanecarboxylate).

Regulatory Recommendations and Residue Chemistry Deficiencies

HED has examined the residue chemistry database for fenpropathrin.  Pending submission of a revised Section F, there are no residue chemistry issues that would preclude granting full registration for the requested use of fenpropathrin on the proposed tropical fruits or establishment of tolerances for residues of fenpropathrin listed in Table 1.

Table 1.  Tolerance Summary for Fenpropathrin
Commodity as Proposed by Registrant
                           Proposed Tolerance (ppm)
                          Recommended Tolerance (ppm)
Comments; Correct Commodity Definition
Guava
                                      1.5
                                      3.0
                                       
Acerola
                                      1.5
                                      3.0
                                       
Feijoa
                                      1.5
                                      3.0
                                       
Jaboticaba
                                      1.5
                                      3.0
                                       
Passionfruit
                                      1.5
                                      3.0
                                       
Starfruit
                                      1.5
                                      3.0
                                       
Wax jambu
                                      1.5
                                      3.0
                                       
Lychee
                                      3.0
                                      7.0
                                       
Longan
                                      3.0
                                      7.0
                                       
Spanish lime
                                      3.0
                                      7.0
                                       
Pulasan
                                      3.0
                                      7.0
                                       
Rambutan
                                      3.0
                                      7.0
                                       
Sugar apple
                                      1.0
                                      1.5
                                       
Atemoya
                                      1.0
                                      1.5
                                       
Biriba
                                      1.0
                                      1.5
                                       
Cherimoya
                                      1.0
                                      1.5
                                       
Custard apple
                                      1.0
                                      1.5
                                       
Ilama
                                      1.0
                                      1.5
                                       
Soursop
                                      1.0
                                      1.5
                                       
Tea
                                      2.0
                                      2.0
Tea, dried
Tolerance should include a footnote stating "There is no U.S. registration on tea, dried, as of (date of FR notice)."

The tolerance for dried tea should include a footnote stating "There is no U.S. registration on tea, dried, as of [date of FR notice]."

860.1550 Proposed Tolerances

   * The tolerance expression proposed by the petitioner should be revised to remove the reference to "combined residues."
      
   * The registrant needs to submit a revised Section F in which the tolerances recommended in Table 1 are proposed.

   * The proposed tolerance for tea should be revised to reflect the correct commodity definition:  "Tea, dried."

Background

The chemical structure and nomenclature of fenpropathrin are presented in Table 2, and the physicochemical properties of the technical grade chemical are presented in Table 3.

Table 2.  Fenpropathrin Nomenclature
Chemical structure
                                       
Common name
Fenpropathrin
Company experimental name
WC-4741706 (Shell); S-5206 (Sumitomo)
IUPAC name
(RS)-α-cyano-3-phenoxybenzyl 2,2,3,3-tetramethylcyclopropanecarboxylate
CAS name
Cyano(3-phenoxyphenyl)methylester 2,2,3,3-tetramethyl-cyclopropanecarboxylic acid
CAS registry number
39515-41-8
End-use product (EP)
2.4 lb/gal EC formulation (Danitol[(R)] 2.4 EC Spray; EPA Reg. No. 59639-35)

Table 3.  Physicochemical Properties of Fenpropathrin
                                   Parameter
                                     Value
                                   Reference
Melting Point/Range
                             45-50ºC (113-122ºF)
DP# 315918, 9/20/05,
W. Cutchin
pH
                               4-5 (1% emulsion)

Density g/cm[3]
                                     1.103

Water Solubility (25ºC)
                                   0.33 ppm

Solvent Solubility (mg/L at 25ºC)
                         Xylene, cyclohexanone:  1000
                                Methanol:  337

Vapor Pressure at 25ºC
                           5.5 x 10[-6] (0.730 mPa)

Dissociation Constant, pKa
                                      NA

Octanol/Water Partition Coefficient, Log(KOW)
                                      5.1

UV/Visible Absorption Spectrum
                                 Not available

860.1200 Directions for Use

The petitioner submitted an undated draft label for the 2.4 lb/gal EC formulation of fenpropathrin (Danitol[(R)] 2.4 EC Spray; EPA Reg. No. 59639-35).  The label includes use directions for a number of fruit, vegetable, and field crops that are already registered.  Danitol[(R)] is currently registered for use on avocado, canistel, mango, papaya, salal, sapodilla, black sapote, mamey sapote, and star apple.  The use directions for both the registered and proposed tropical and subtropical fruits are presented in Table 4.  No directions were proposed for the domestic use of fenpropathrin on tea.
 
Table 4.  Summary of Directions for Use of Fenpropathrin
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
Tropical and Subtropical Fruit:  Acerola, Atemoya, Avocado, Biriba, Canistel, Cherimoya, Custard Apple, Feijoa, Guava, Ilama, Jaboticaba, Longan, Lychee, Mango, Papaya, Passion Fruit, Pulasan, Rambutan, Sapodilla, Sapote (Black, Mamey), Soursop, Spanish Lime, Star Apple, Star Fruit, Sugar Apple, and Wax Jambu
Foliar
Ground (all crops)

Aerial (avocado only)
                                 2.4 lb/gal EC
                                  [59639-35]
                                    0.3-0.4
                                  1 (avocado)
                                       
                                      or
                                       
                              2 (all other crops)
                                      0.8
                                       1
Begin applications when first pest activity is noticed.  A 14-day retreatment interval is specified.  Ground applications are to be made in >=75 gal/A; aerial applications to avocado may be made in >=50 gal/A.

The use directions for the proposed tropical and subtropical fruits are identical to those for the registered tropical and subtropical fruits, except that the minimum spray volume for ground applications for all tropical fruits has been reduced from 100 gal/A to 75 gal/A.

The label states that the product may not be applied through any type of irrigation system, and that tank mixing or use of the product with any other product which is not specifically and expressly authorized by the label shall be the exclusive risk of the user, applicator, and/or applicator advisor.  No tank mix instructions are included for tropical fruits.

The label states that there are no rotational crop restrictions for the product.

Conclusions.  The submitted use directions for tropical and subtropical fruits are adequate to allow evaluation of the residue data relative to the proposed use.  The submitted crop field trials on guava, lychee, and sugar apple/atemoya were conducted according to the proposed use pattern.  

No spray adjuvants were used in the submitted crop field trials on guava, lychee, and sugar apple/atemoya or in the avocado field trials previously submitted to support use on the registered tropical and subtropical fruits (D320347, A. Parmar, 11/26/08).  HED has concluded that spray adjuvant use must be prohibited on product labels when the field trials did not include adjuvants (ChemSAC minutes of 4/16/08).  Therefore, product labels must be amended to specify that adjuvants may not be added to spray mixtures for uses on tropical and subtropical fruits.

860.1300 Nature of the Residue - Plants

Residue Chemistry Memo D207266, R. Cook, 8/9/95
Residue Chemistry Memo D208548, R. Cook, 5/2/95
Residue Chemistry Memo D181992, M. Bradley, 11/4/92 
Residue Chemistry Memo PP#4G03107, R. Loranger, 10/23/84

The nature of the residue in plants is adequately understood based on acceptable metabolism studies conducted on apple, cotton, pinto beans, and tomatoes.  The residue of concern is the parent compound fenpropathrin.

860.1300 Nature of the Residue - Livestock

There are no livestock feedstuffs associated with the proposed use on tropical fruits.  Therefore, data requirements for livestock metabolism are not relevant to this tolerance petition.

860.1340 Residue Analytical Methods

Residue Chemistry Memo PP#7F3485, M. Bradley 10/24/88

Enforcement method:  An adequate method, Residue Method Number RM-22-4  is available for the enforcement of tolerances of fenpropathrin in plants.  Residues in crops are extracted with acetone/hexane, partitioned into hexane, cleaned up by silica gel and C18 Sep Pak chromatography, and analyzed by GC/ECD.  The LOD is 0.01 ppm.  The method has undergone a successful Agency method trial and has been forwarded to FDA for publication in the Pesticide Analytical Manual Vol. II.

Data collection methods:  Samples of guava, lychee, sugar apple, and atemoya from the tropical fruit field trials were analyzed using a revised version of the enforcement method.  In addition to minor modifications to the original method, the revised method uses GC/MS-SIM analysis instead of GC/ECD.  Briefly, samples were extracted twice with acetone:hexane (1:2, v:v), and the extracts were filtered through sodium sulfate.  The filtrate was mixed with sodium chloride solution, and the phases were allowed to separate.  The hexane layer was filtered through sodium sulfate and reserved, and the aqueous layer was partitioned twice with hexane.  The resulting aqueous phase was discarded, and the hexane layer was filtered through sodium sulfate and combined with the first hexane layer.  The combined fraction was concentrated, redissolved in hexane, and partitioned twice with acetonitrile (ACN).  The resulting ACN phases were combined, evaporated to dryness, redissolved in hexane, and applied to a silica gel column.  Residues were eluted with ether:hexane (1:5, v:v).  The eluate was evaporated to dryness, redissolved in methanol, and applied to a C18 Sep Pak cartridge.  Residues were eluted with methanol.  The eluate was evaporated to dryness and redissolved in hexane for GC/MS-SIM analysis.

The method was adequate for data collection based on acceptable method validation and concurrent recovery data.  Fortification levels were adequate to bracket residues found in treated samples.  The calculated limits of quantitation (LOQs) were 0.035, 0.023, and 0.018 ppm for guava, lychee, and sugar apple/atemoya, respectively.  The LLMV was 0.02 ppm for all matrices.  

Samples of dried black tea leaves from the tea field trials were analyzed for residues of fenpropathrin using GC/ECD methods.  Slightly different methods were used for analysis of samples from trials conducted in different locations.

Briefly, samples from the Tamil Nadu trials were extracted with ACN:water (2:1, v:v) and filtered.  A 4% NaCl solution was added to the filtrate, which was then partitioned with hexane.  The hexane layer was passed through sodium sulfate and evaporated to dryness, then redissolved in hexane, and partitioned with ACN-saturated hexane.  The ACN layer was evaporated to dryness, redissolved in hexane, and applied to a Florisil column.  Residues were eluted with 6% diethyl ether in hexane.  The resulting eluate was concentrated to dryness and diluted with hexane for analysis by GC/ECD.  The LOQ, based on reported residue results, was 0.05 ppm.  The reported limit of detection was 0.005 ppm.

Samples from the Assam trial were rehydrated in distilled water, then extracted with n-hexane:acetone (4:1, v:v).  An aliquot of the extract was washed with NaCl solution then partitioned with hexane, and the extract was cleaned with alumina for analysis by GC/ECD.  The reported limit of quantitation was 0.02 ppm.  

The methods are considered to be adequate based on concurrent recovery data reflecting a single fortification level (0.283 ppm) and method validation data reflecting fortification levels of 0.02-0.1 ppm.  The fortification levels for concurrent recovery did not encompass residues found in dried black tea leaves.  

Conclusions.  The residue analytical methods data are adequate to satisfy data requirements for this petition.  Acceptable methodology is available for tolerance enforcement purposes for residues of concern in/on crop commodities.  Residues of fenpropathrin in/on samples from the tropical fruit crop field trials were determined using an acceptable data collection method based on the enforcement method.  Although only limited data were provided for the analytical methods used for analysis of samples from the tea field trials, RAB2 concludes that the methods are adequate for the purposes of this petition.

860.1360 Multiresidue Methods

The FDA PESTDATA database (dated 6/2005) indicates that fenpropathrin is completely recovered by multiresidue methods Section 302 (Protocol D).  Recovery was variable using Section 303 (Protocol E; 43-71% recovery) and Section 304 (Protocol F; 58-114% recovery).  

860.1380 Storage Stability

Residue Chemistry Memo D222174, L. Cheng, 10/23/97
Residue Chemistry Memo D200755, R. Cook, 11/21/95
Residue Chemistry Memo D160414, M. Bradley, 1/29/92
Residue Chemistry Memo PP#7F3485/7H5527, M. Bradley, 9/11/87

Previously submitted storage stability data have demonstrated that fortified residues of fenpropathrin are reasonably stable under frozen storage conditions for up to 4 months in peanut presscake, 6 months in melons and cabbage, 9 months in broccoli, and 12 months in peanut nutmeat.  The data also indicate that weathered residues of fenpropathrin are stable during frozen storage for up to ~5 months in peanut oil; 11 months in orange oil and dried peel (pulp); 12 months in apples, cotton seed, grapes, oranges, and pears; 13 months in peanut vines; 14 months in grape juice; and 15 months in peanut hulls and hay.

A concurrent storage stability study was conducted to support the storage intervals and conditions of samples from the submitted tropical fruit field trials.  The data demonstrate that residues of fenpropathrin are stable in/on fortified samples of guava, lychee, and atemoya stored frozen for up to 243, 271, and 272 days (8.0-8.9 months).  No 0-day data were provided in the concurrent storage stability study.  Storage stability studies should always include a 0-day sampling interval to establish the residue levels present at the time samples are placed into storage (see OPPTS 860.1380(d)(6)(i)).

The storage durations and conditions of samples from the crop field trials submitted to support this petition are presented in Table 5. 

Table 5.  Summary of Storage Conditions and Durations of Samples from Crop Field Trial Studies  
Matrix 
                              Storage Temperature
                                     (°C)
                            Actual Storage Duration
                  Interval of Demonstrated Storage Stability
Guava
                                    <=-20
7-239 days (0.2-7.9 months)
Concurrent storage stability data indicate that residues of fenpropathrin are stable for up to 243 days in/on guava, 271 days in/on lychee, and 272 days in/on atemoya.
Lychee
                                       
257-265 days (8.5-8.7 months)
                                       
Sugar apple/
atemoya
                                       
25-132 days (0.8-4.3 months)
                                       
Black tea - dried leaves
                                 Not reported
"If samples were stored for >24 hours prior to analysis, stability of the residues was demonstrated with recovery studies performed under similar conditions."
Adequate storage stability data are available for fenpropathrin, demonstrating that fortified and weathered residues are stable during frozen storage for at least one year in/on various crop commodities, including peanut vines, hulls, and hay.

                                 Not reported
"Analyzed immediately after receipt in the laboratory; extensive storage was not required."

Conclusions.  The submitted concurrent storage stability data for guava, lychee, sugar apple, and atemoya are adequate to support the tropical fruit crop field trials.  The data indicate that there are no storage stability issues.  No corrections for decline during storage are needed.  

Although only limited information was provided concerning the storage intervals and conditions of samples from the tea crop field trials, RAB2 concludes that no additional data are required based on (1) the statements provided by the petitioner concerning the likely duration of sample storage, and (2) the available storage stability data for fenpropathrin, which indicate that residues are stable on a variety of crops stored frozen.  

860.1400 Water, Fish, and Irrigated Crops

The proposed uses are not directly relevant to this guideline topic.

860.1460 Food Handling

Fenpropathrin is not registered for use in food handling establishments and no food handling establishment uses are being proposed.  As a result, this guideline topic is not relevant to this tolerance petition.

860.1480 Meat, Milk, Poultry, and Eggs

There are no livestock feedstuffs associated with the proposed use on tropical fruits or tea.  Therefore, data requirements pertaining to meat, milk, poultry, and eggs are not relevant to this tolerance petition.

In the previous risk assessment that was prepared for fenpropathrin (D313330, D. Dotson, 11/26/2008), HED recommended in favor of reassessed tolerances for cattle, goat, hog, horse, and sheep commodities.  HED recommended that the tolerance for the meat and meat byproducts of cattle, goats, horses, and sheep be reduced to 0.01 ppm.  HED recommended that the tolerance for the fat of these same commodities be reduced to 0.05 ppm.  HED recommended that tolerance for milk fat be reduced to 0.05 ppm (reflecting 0.002 ppm in whole milk).  Finally, HED recommended that the tolerances for hog commodities (fat, meat, and meat byproducts) be removed.  The revisions have not been made to the 40CFR listing for fenpropathrin.  RD should ensure that 40CFR §180.466 is updated with the recommended tolerances.

860.1500 Crop Field Trials

DER Reference:	47813101.der.doc (Guava, lychee, sugar apple, and atemoya)
		47813102.der.doc (Tea)

Tropical Fruits

IR-4 submitted field trial data for fenpropathrin on the tropical fruits guava, lychee, and sugar apple/atemoya.  Atemoya is a hybrid of sugar apple, and the two crops are considered to be identical for the purposes of generating residue data.  Twelve tropical fruit field trials were conducted in the U.S. in Zone 13 during the 2005 and 2006 growing seasons.  Three trials were performed for each crop.  Two of the guava trials were conducted in Florida and one was conducted in Hawaii.  Likewise, two of the lychee trials were conducted in Florida and one was conducted in Hawaii.  Finally, two sugar apple trials were conducted in Florida, and one atemoya trial was conducted in Hawaii.

At each test site, one untreated and one treated plot were established.  The treated plots received two foliar directed applications of a 2.4 lb/gal EC formulation of fenpropathrin at 0.392-0.425 lb ai/A/application, with a 9- to 10-day retreatment interval, for a total seasonal rate of 0.784-0.844 lb ai/A (~1x the maximum proposed seasonal application rate).  The applications were made during fruiting growth stages and were directed to the trees (aged 9-15 years).  Applications were made using ground equipment, in concentrate spray volumes of 111-176 gal/A (HI trials for guava, lychee, and atemoya, and one FL trial for sugar apple) or dilute spray volumes of 66-77 lb/gal (two FL trials each for guava and lychee and one FL trial for sugar apple).  No adjuvant was added to the spray mixtures.  Commercially mature fruit samples were collected 1 day after the second application.

Samples of guava, lychee, sugar apple, and atemoya were analyzed for residues of fenpropathrin using an adequate GC/MS-SIM method.  The LLMV was 0.02 ppm for all matrices.  Sample storage intervals and conditions are reported in Table 5.  Adequate concurrent storage stability data were submitted to support the crop field trials.
The results of the tropical fruit crop field trials are presented in Table 6.  Residues of fenpropathrin were 0.484-1.09 ppm, 2.07-2.58 ppm, and 0.248-0.699, respectively, in/on six samples each of guava, lychee, and sugar apple/atemoya harvested at a 1-day PHI following two foliar directed applications of the 2.4 lb/gal EC formulation of fenpropathrin at total seasonal rates of 0.784-0.844 lb ai/A.  For the concentrate and dilute spray applications, respectively, residues were 0.949-1.09 and 0.484-0.608 ppm in/on guava, 2.42-2.58 and 2.07-2.46 ppm in/on lychee, and 0.369-0.554 and 0.248-0.699 ppm in/on sugar apple and atemoya.

Table 6.  Summary of Residue Data from Crop Field Trials with Fenpropathrin.
Crop matrix
                              Total Applic. Rate
                                   (lb ai/A)
                                  PHI (days)
                             Residue Levels (ppm)

                                       n
                                     Min.
                                     Max.
                                    HAFT[1]
                                    Median
                                     Mean
                                   Std. Dev.
                        TROPICAL AND SUBTROPICAL FRUITS
        (proposed use = 0.8 lb ai/A total application rate, 1-day PHI)
Guava
                                  0.784-0.822
                                       1
                                       6
                                     0.484
                                     1.09
                                     1.02
                                     0.593
                                     0.713
                                     0.247
Lychee
                                  0.800-0.844
                                       1
                                       6
                                     2.07
                                     2.58
                                     2.50
                                     2.39
                                     2.34
                                     0.199
Sugar apple/atemoya
                                  0.812-0.816
                                       1
                                       6
                                     0.248
                                     0.699
                                     0.482
                                     0.403
                                     0.446
                                     0.158
[1]  HAFT = Highest average field trial result.

Conclusions.  The submitted field trial residue data for guava, lychee, and sugar apple/atemoya are adequate.  Trials were conducted according to the proposed use pattern, samples were analyzed for residues of fenpropathrin using an acceptable method, and adequate storage stability data were submitted to support the study.

All trials were conducted in EPA Growing Zone 13, which is the major production region for tropical crops in the United States.  The numbers of field trials for each crop are not strictly in accordance with OPPTS 860.1500 for the three crops.  Table 1 recommends one trial with four treated samples each for atemoya and lychee, and two trials with eight treated samples for guava.  RAB2 concludes that the submitted field trial data, reflecting three trials with six samples each for each crop, as well as applications in dilute and concentrate spray volumes divided equally between the trials, are adequate to support the proposed uses.  No residue decline data are required to support the trials.
 
As specified in the "Reviewer's Guide and Summary of HED ChemSAC Approvals for Amending Crop Group/Subgroups (40 CFR 180.41) and Commodity Definitions (40 CFR 180.1(h))" B. Schneider, 6/14/06, the submitted data for guava, lychee, and sugar apple/atemoya may be translated to support uses and tolerances on the following tropical fruit crops as follows:   (1) guava uses/tolerances may be translated to feijoa, jaboticaba, wax jambu, starfruit, passionfruit, and acerola; (2) lychee uses/tolerances may be translated to longan, Spanish lime, rambutan, and pulasan; and (3) sugar apple/atemoya uses/tolerances may be translated to custard apple, cherimoya, ilama, soursop, and biriba.  

The available guava, lychee, and sugar apple/atemoya data support tolerances of 3.0 ppm for guava, acerola, feijoa, jaboticaba, passionfruit, starfruit, and wax jambu; 7.0 ppm for lychee, longan, Spanish lime, pulasan, and rambutan; and 1.5 ppm for sugar apple, atemoya, biriba, cherimoya, custard apple, ilama, and soursop.  Refer to Attachment 1 for the tolerance calculations.  The registrant needs to submit a revised Section F in which the recommended tolerances are proposed. 
Tea

IR-4 submitted a report summarizing the results of two studies on tea conducted in India.  An Indian label was not submitted.  However, the following use pattern information was provided for India:  shoots along with bud are typically harvested at a 7-day PHI.  The application rate was not stipulated; however, in Tamil Nadu, field trials were performed at two different application rates:  0.052 and 0.10 lb ai/A.  The lower rate was identified as the normal dose and the higher rate was referred to as a double dose.  Therefore, HED infers that the 1x application rate is 0.052 lb ai/A.

Five black tea trials at three trial sites were conducted in India during the 2002, 2004, and 2005 growing seasons.  The trial sites were selected to reflect different agricultural climatic regions of India (high and low elevations as well as wet and dry season treatments).  Four trials located in Tamil Nadu were conducted by the Tea Research Foundation of the United Planters Association of South India (UPASI).  One trial located in Assam was conducted by the Tea Research Association (TRA) at the Tocklai Experimental Station in Jorhat.  Only limited details were provided concerning the field phase of the studies.  No information was provided concerning weather or crop maintenance procedures, and only general information was provided concerning the location of the field trials.  Because no raw data were included in the submission, all data presented herein are as reported in the original study reports.

At two trial sites in Tamil Nadu, four trials were conducted:  two during the wet season and two during the dry season.  In each trial, fenpropathrin was applied to black tea in separate plots as a single broadcast foliar application of a 300 g/L (2.5 lb/gal) EC formulation at 0.052 lb ai/A (0.059 kg ai/ha) or 0.10 lb ai/A (0.12 kg ai/ha) in spray volumes of 48 gal/A (450 L/ha).  A fifth trial was conducted during the dry season in Assam, India, where the 300 g/L EC formulation was applied as a single broadcast foliar spray at 0.029 lb ai/A (0.032 kg ai/ha) in a spray volume of 43 gal/A (400 L/ha).

Samples of green shoots (~1-2 kg; 70% of the green shoots consisted of two leaves and a bud) were collected from treated plots by hand at PHIs of 0, 1, 3, 5, 7, 10, and 14 days.  The report did not indicate whether control samples were collected.  Samples were processed in a tea factory into dried black tea leaves under controlled conditions following the normal black tea manufacturing process, which involves withering (reduction of moisture in the plucked shoots), rolling, oxidation (fermentation), and drying.  

Samples of dried black tea leaves were analyzed for residues of fenpropathrin using acceptable GC/ECD methods, with an apparent LOQ of 0.05 ppm for Tamil Nadu samples and 0.02 ppm for Assam samples.  Only limited information was provided concerning sample storage durations for the studies, and storage conditions were not addressed (Table 5).  For purposes of this review only, RAB2 has concluded that no additional storage stability data are needed to support the studies.

The results of the tea crop field trials are presented in Table 7.  As stated above, four trials were performed in Tamil Nadu (two at an application rate of 0.052 lb ai/A (1x), and two at an application rate of 0.10 lb ai/A (2x)).  At a 7-day PHI, average residues at the 1x application rate were 0.17, 0.18, 0.14, and <0.05 ppm.  At the trial performed in Jorhat, Assam, where the application rate was 0.029 lb ai/A, the average residue was 1.38 ppm at a 7-day PHI.  Results were also provided for samples harvested at PHIs of 0, 1, 3, 5, 10, and 14 days for tea harvested from the trials conducted in Tamil Nadu.  Residues of fenpropathrin declined with increasing sampling interval.  

At one trial site in Tamil Nadu where trials were conducted during the wet season and dry season in the same year, comparison of the results for the wet and dry season trials indicates that residues were comparable (at both the 0.052 and 0.10 lb ai/A application rates).

Table 7.  Summary of Residue Data from Crop Field Trials with Fenpropathrin.
Crop matrix
                              Total Applic. Rate
                                   (lb ai/A)
                                  [kg ai/ha]
                                  PHI (days)
                             Residue Levels (ppm)

                                       n
                                     Min.
                                     Max.
                                    HAFT[1]
                                    Median
                                     Mean
                                   Std. Dev.
        TEA (no proposed domestic use; India GAP specifies a 7-day PHI)
Black tea - dried leaves
                          0.029, 0.052 [0.032, 0.059]
                                       0
                                       5
                                     0.85
                                     12.03
                                     12.03
                                     2.69
                                     4.11
                                     4.49

                                       
                                       7
                                       5
                                   <0.05
                                     1.38
                                     1.38
                                     0.17
                                     0.38
                                     0.56

                                       
                                      14
                                       5
                                   <0.05
                                     0.12
                                     0.12
                                     0.05
                                     0.06
                                     0.03

                                  0.10 [0.12]
                                       0
                                       4
                                     1.62
                                     5.50
                                     5.50
                                     4.82
                                     4.19
                                     1.78

                                       
                                       7
                                       4
                                   <0.05
                                     0.37
                                     0.37
                                     0.33
                                     0.27
                                     0.15

                                       
                                      14
                                       4
                                   <0.05
                                   <0.05
                                   <0.05
                                     0.05
                                     0.05
                                      --
[1]  HAFT = Highest average field trial result.

No data were included reflecting residues in brewed tea.  The report stated that studies on transfer of fenpropathrin residues from dried tea leaves to brewed tea indicated that there is no transfer of the chemical residues in the hot water brew of tea for samples from the Tamil Nadu trials and that only up to 0.2% of fenpropathrin residues in dried tea leaves was found to transfer into tea brew for samples from the Assam trial.  These observations are consistent with fenpropathrin's high octanol/water partition coefficient and low water solubility.

The study report also contained a list of multiresidue method analysis results provided by The Tetley Group, ShanShan Tea, and Finlay Tea for fenpropathrin residues in tea.  The data provided by the Tetley Group contained the results from analyses of black, green, oolong, and white tea in commercial shipments from India (n=151), Bangladesh (n=2), Sri Lanka (n=3), China (n=12), Vietnam (n=4), Indonesia (n=13), Papua New Guinea (n=2), Argentina (n=3), Kenya (n=12), Malawi (n=4), Tanzania (n=4), Zimbabwe (n=4), Uganda (n=1), South Africa (n=2), Rwanda (n=2), and Ethiopia (n=1).  Of 220 samples tested in 2007-2009, 10 contained quantifiable residues (>=0.01 ppm) at 0.01-0.08 ppm.  The data provided by ShanShan Tea contained a summary of the results of the analyses of 917 samples of green, black, oolong, and white teas from different tea production regions of China.  Of these samples, 780 contained residues in the range of 0.01 to 0.1 ppm and 137 contained residues in the range of 0.1 to 1 ppm.  Individual sample results were not reported.  The data provided by Finlay Tea consisted of results for 28 samples from China (23 samples) and India (5 samples) from 2006-2008.  Residues were 0.01-0.04 ppm in samples from China and 0.02-0.85 ppm in samples from India. 

Conclusions.  The submitted field trial residue data for tea are adequate to set a tolerance without U.S. registration in dried tea.  

The available data are sufficient to illustrate the magnitude of the residue of fenpropathrin in dried tea leaves grown in India and treated with fenpropathrin at 0.03 to 0.10 lb ai/A (0.03 to 0.12 kg ai/ha).  The maximum residues observed in samples of tea harvested at a 7-day PHI in the submitted field trials were significantly higher (up to ~12x) than those observed in commercial shipments of tea from various countries tested in 2006-2009.  Samples were analyzed for residues of fenpropathrin using tentatively acceptable analytical methods, and no additional storage stability data are required to support the study.

Essentially 100% of the tea consumed in the U.S. is imported (USDA Economic Research Service).  As the dietary contribution of tea is <0.05% of the diet for any population subgroup (NAFTA Guidance Document on Data Requirements for Tolerances on Imported Commodities in the United States and Canada), three tea field trials are required to support an import tolerance on tea.  The major exporters of tea to the U.S. from 2004-2008 were Argentina (21.3% total U.S. imports), Canada (24.1%), Mexico (14.2%), China (11.9%) and India (5.3%)  (USDA Foreign Agricultural Service).  However, Canada and Mexico are not major tea producers, and the tea imports from these two countries are comprised of tea that has been imported into Canada and Mexico and then repackaged for export to the U.S.  Based on the relative amounts of tea imported from countries that are actually major tea producers, three tea trials would be required from Argentina, China, and India (1 trial each) to support a world-wide use of fenpropathrin on tea.  The submitted data only reflect residues in/on tea grown in India.  In the submitted monitoring data, representing mostly samples from India and China, residues in/on tea samples from India were generally the same as or greater than residues in/on tea samples from China.  

Using the OECD MRL calculation procedures, the recommended tolerance for dried tea would be 3.0 ppm.  A Codex MRL is established for residues of fenpropathrin in/on tea, green, black at 2.0 ppm.  For the purposes of harmonization of the U.S. tolerance with the established Codex MRL, HED recommends in favor of a tolerance of 2.0 ppm for dried tea.  HED considers this to be a reasonable tolerance because the highest average field trial value was 1.38 ppm.

860.1520 Processed Food and Feed

There are no processed commodities associated with the proposed uses.
  
860.1650 Submittal of Analytical Reference Standards

An analytical reference standard for fenpropathrin is currently available in the EPA National Pesticide Standards Repository (electronic communication, Teresa Cole, 6/1/2012).  The expiration date of the standard is 7/20/2012. 

860.1850 and 860.1900 Confined and Field Accumulation in Rotational Crops

Because the tropical fruits addressed herein are not rotated, no data pertaining to rotational crops are required to support the proposed use. 

860.1550 Proposed Tolerances

Tolerances are established for residues of fenpropathrin in or on various plant and livestock commodities (40 CFR §180.466).  The tolerance expression proposed by the petitioner is appropriate, except that the reference to "combined residues" should be removed.  

A Codex MRL is established for residues of fenpropathrin in/on tea, green, black at 2 ppm.  No Canadian MRLs are established, and no Mexican MRLs are established for the crops in this petition.

Adequate field trial data reflecting the proposed use pattern are available for purposes of establishing tolerances on guava, lychee, and sugar apple/atemoya and on the corresponding tropical fruits designated in the "Reviewer's Guide and Summary of HED ChemSAC Approvals for Amending Crop Group/Subgroups [40 CFR 180.41] and Commodity Definitions [40 CFR 180.1(h)]" (B. Schneider, 6/14/06).  The OECD MRL calculation procedures were used to determine the appropriate tolerance levels for guava, lychee, and sugar apple/atemoya.  The recommended tolerances for the proposed commodities are listed in Table 1.  The registrant needs to submit a revised Section F in which the recommended tolerances are proposed.

Adequate field trial data reflecting use of fenpropathrin on tea grown in India are available for establishing an import tolerance on dried tea.  Based on the submitted data reflecting application at total rates of 0.029 or 0.052 lb i/A (0.032 or 0.059 kg ai/ha) with a 7-day PHI, the OECD MRL calculation procedures recommend a tolerance of 3.0 ppm for dried tea.  However, for purposes of harmonization of the U.S. tolerance with the established Codex MRL, the recommended tolerance of 2.0 ppm is appropriate.  The proposed tolerance for tea must be revised to reflect the correct commodity definition:  "Tea, dried."

Although no data were provided for brewed tea, the study reports indicated that only up to 0.2% of fenpropathrin residues transferred from dried tea leaves to brewed tea.  The experimental factor of 0.2% is consistent with fenpropathrin's high octanol/water partition coefficient and low water solubility.  

References

PP#4G3107, Fenpropathrin (Danitol(R)) on cottonseed.  Evaluation of analytical method and residue data, R. Loranger, 10/23/84, MRIDs 00126816-00126826

PP#7F3485/7H5527.  Fenpropathrin (Danitol) on Apples and Pears.  Evaluation of Analytical Method and Residue Data.  CB Nos. 1984 and 1985, M. Bradley, 9/11/87, MRIDs: 40024604-40024619 and 40068701

PP#7F3485/FAP#7H5527.  Fenpropathrin (Danitol) on Apples and Pears.  Comments on Petition Method Validation, M. Bradley, 10/24/88

D160414, PP#1F3949, Fenpropathrin (127901 Danitol) on Cotton, Grapes and Oranges.  Evaluation of Analytical Method and Residue Data.  CB No. 7574, M. Bradley, 1/29/92, MRIDs: 41734001-41734003

D181992, PP#1F3949/FAP2H5639, 2F04144/2H05648, 7F03485.  Fenpropathrin (127901 Danitol) on Cotton, Grapes and Oranges.  Amendments of August 4 and 7, 1992.  CB Nos. 10492, 10494, 10495, 10496, 10497, and 10498, M. Bradley, 11/4/92, MRIDs:  42429500 and 42429501

D208548, PP#2F04144/2H05648, Fenpropathrin (127901 Danitol(R)) on Cotton.  Submission of Cotton Metabolism Study.  CB Nos. 10492 and 10493, R. Cook, 5/2/95, MRIDs:  43399200 and 43399201

D207266, PP3F4186/FAP3H5661, Fenpropathrin (127901 Danitol) on Tomatoes and Strawberries.  Amendments dated 9/1/94 and 5/16/95.  CB Nos. 14342, 14343, 15651, 15652, R. Cook, 8/9/95, MRIDs:  43360500-43360503, 43652400, and 43652401

D200755, PP4F04327/FAP4H05690:  Fenpropathrin (127901) on peanuts.  Evaluation of analytical methods and residue data.  Submitted by Valent USA Corporation.  CB Nos. 13420 and 13421, R. Cook, 11/21/95, MRID:  43137701

D222174, PP#6F4648.  Fenpropathrin on Melons and Brassica.  PC Code 127901.  Evaluation of Analytical Methods and Residue Data.  CB No. 16743, L. Cheng, 10/23/97, MRIDs:  43876401-43876403

D315918, Fenpropathrin.  Residue Field Trials on Currants, Succulent Shelled Peas, Blueberries, and Peppers.  Summary of Analytical Chemistry and Residue Data.  PP#s 1E6261, 1E6331, 1E6336, and 3E6588, W. Cutchin, 9/20/05, MRIDs:	45317201, 45439801, 45454701, 45919601

D320347, Fenpropathrin.  Request for Tolerances for Barley, Stone Fruits (Crop Group 12), Tree Nuts including Pistachio (Crop Group 14), Caneberries (Crop Subgroup 13-07A), Olives, Avocado, Black Sapote, Canistel, Mamey Sapote, Mango, Papaya, Sapodilla, and Star Apple.  Summary of Analytical Chemistry and Residue Data.  PP#s 6E7066, 4E6867, and 7E7298, A. Parmar, 11/26/08, MRIDs:  46385302-46385306, 46814801, 46814802, 47295501, 47295502

Attachments:  
Attachment 1:  International Residue Limit Status Sheet
Attachment 2:  Tolerance Assessment Calculations

            Attachment 1.  International Residue Limit Status Sheet

                       Fenpropathrin (127901; 5-31-2012)
                                       
Summary of US and International Tolerances and Maximum Residue Limits 
Residue Definition:  
US
Canada
Mexico[2]
Codex[3]
40 CFR 180.466   

Plants/Livestock:  fenpropathrin (alpha-cyano-3-phenoxy-benzyl 2,2,3,3-tetra
methylcyclopropanecarboxylate)
None

fenpropathrin. The residue is fat-soluble.

Commodity[1]
Tolerance (ppm) /Maximum Residue Limit (mg/kg)

                                      US
                                    Canada
                                   Mexico[2]
                                   Codex[3]
Tea, dried
                                      2.0

2 Tea, green, black (black, fermented and dried)
Guava
                                      3.0

Acerola
                                      3.0

Feijoa
                                      3.0

Jaboticaba
                                      3.0

Passionfruit
                                      3.0

Starfruit
                                      3.0

Wax Jambu
                                      3.0

Lychee
                                      7.0

Longan
                                      7.0

Spanish Lime
                                      7.0

Pulasan
                                      7.0

Rambutan
                                      7.0

Sugar Apple
                                      1.5

Atemoya
                                      1.5

Biriba
                                      1.5

Cherimoya
                                      1.5

Custard Apple
                                      1.5

Ilama
                                      1.5

Soursop
                                      1.5

                                       

Completed:  M. Negussie; 06/01/2012
[1] Includes only commodities of interest for this action.  Tolerance values should be the HED recommendations and not those proposed by the applicant.
2 Mexico adopts US tolerances and/or Codex MRLs for its export purposes.

3 * = absent at the limit of quantitation; Po = postharvest treatment, such as treatment of stored grains.  PoP = processed postharvest treated commodity, such as processing of treated stored wheat. (fat) = to be measured on the fat portion of the sample. MRLs indicated as proposed have not been finalized by the CCPR and the CAC.

                                       
               Attachment 2:  Tolerance Assessment Calculations

For each of the crops listed below, the OECD MRL Calculator was used for calculating recommended tolerances.  Average field trial values were entered into the calculator.
 
Tropical fruits - Guava, lychee, and sugar apple/atemoya

The dataset used to establish tolerances for fenpropathrin on the tropical fruits guava, lychee, and sugar apple/atemoya consisted of field trial data representing applications at rates of 0.784-0.844 lb ai/A (two applications at 0.392-0.425 lb ai/A/application) with a 1-day PHI.  The field trial application rates and PHIs are within 25% of the maximum label application rate and minimum label PHI, respectively.  Using the MRL calculator, the recommended tolerances have been determined to be 3.0 ppm for guava, 7.0 ppm for lychee, and 1.5 ppm for sugar apple/atemoya.  

Tea

The dataset used to establish a tolerance for fenpropathrin on dried tea consisted of field trial data for dried black tea representing application rates of 0.029 and 0.052 lb ai/A (single application) with a 7-day PHI.  The petitioner has indicated that the field trial application rates and PHIs are representative of the expected use pattern for fenpropathrin on tea in India.

Using the MRL calculator, the recommended tolerance is 3.0 ppm for dried tea.  A Codex MRL is established for residues of fenpropathrin in/on tea, green, black at 2.0 ppm.  For purposes of harmonization of the U.S. tolerance with the established Codex MRL, HED recommends in favor of a tolerance of 2.0 ppm for dried tea.  The highest average field trial value was 1.38 ppm.

            OECD MRL Calculator Results for Tropical Fruits and Tea

OECD MRL Calculator Results for Tropical Fruits and Tea
Compound
 
                                 Fenpropathrin
                                 Fenpropathrin
                                 Fenpropathrin
                                 Fenpropathrin
Crop
 
                                     Guava
                                    Lychee
                              Sugar Apple/Atemoya
                                      Tea
Region / Country
 
                                  Zone 13/USA
                                  Zone 13/USA
                                  Zone 13/USA
                                     India
GAP
 
                                  0.8 lb ai/A
                                  0.8 lb ai/A
                                  0.8 lb ai/A
                                  0.1 lb ai/A
Total number of data (n)
 
                                       3
                                       3
                                       3
                                       5
Percentage of censored data
 
                                      0%
                                      0%
                                      0%
                                      20%
Number of non-censored data
 
                                       3
                                       3
                                       3
                                       4
Lowest residue
 
                                     0.546
                                     2.100
                                     0.382
                                     0.050
Highest residue
 
                                     1.020
                                     2.500
                                     0.482
                                     1.380
Median residue
 
                                     0.572
                                     2.410
                                     0.474
                                     0.170
Mean
 
                                     0.713
                                     2.337
                                     0.446
                                     0.384
Standard deviation (SD)
 
                                     0.266
                                     0.210
                                     0.056
                                     0.559
Correction factor for censoring (CF)
 
                                     1.000
                                     1.000
                                     1.000
                                     0.867
- Highest residue
 
                                     1.020
                                     2.500
                                     0.482
                                     1.380
- Mean + 4 SD
 
                                     1.779
                                     3.176
                                     0.668
                                     2.621
- CF x 3 Mean
 
                                     2.138
                                     7.010
                                     1.338
                                     0.998
Unrounded MRL
 
                                     2.138
                                     7.010
                                     1.338
                                     2.621
                                       
Rounded MRL
 
                                       3
                                       7
                                      1.5
                                       3
                                       
 
 
            High uncertainty of MRL estimate due to small dataset.
            High uncertainty of MRL estimate due to small dataset.
            High uncertainty of MRL estimate due to small dataset.
            High uncertainty of MRL estimate due to small dataset.
 
 
                               Residues (mg/kg)
                               Residues (mg/kg)
                               Residues (mg/kg)
                               Residues (mg/kg)
 
 
                                     0.546
                                       
                                     2.410
                                       
                                     0.482
                                       
                                     0.170
                                       
 
 
                                     0.572
                                       
                                     2.100
                                       
                                     0.474
                                       
                                     0.180
                                       
 
 
                                     1.020
                                       
                                     2.500
                                       
                                     0.382
                                       
                                     0.140
                                       
 
 
                                       
                                       
                                       
                                       
                                       
                                       
                                     0.050
                                       *
 
 
                                       
                                       
                                       
                                       
                                       
                                       
                                     1.380