Page 1 of 20 **UNITED STA TES ENVIRONMENTA**  **L PROTECTION A GENCY** 

**WA SHINGTON, 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 L ime, Pulasan, Rambutan, Sugar Apple, Atemoya, Biriba, Cherimo ya, Custard Apple, Ilama, and Soursop. Request for a Tolerance Without U.S. Registration on Tea. Summary of Analy tical Chemistry

and Residue Data
. **PC Code:** 127901 **DP Barcode:** D 368340 **Decision No.:** 417627 **Registration No. :**  59639
- 35 **Petition No.:** 9E7594 **Regulatory Action:** Amended Section 3 **Risk Assessment Type:** NA **Case No.:** NA **T XR No.:**  NA **CAS No.:** 39515
- 41
- 8 **MRID No s**  **.:** 47813101, 478 1 3102 **40 CFR:** 180. 466
**FROM:** Douglas Dotson, Ph.D., Chemist

Risk Assessment Branch II Health Effects Division **THROUGH:** Dennis McNeill y , 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
- phenox y - benzyl 2,2,3,3

- tetrameth yl cyclopropanecarboxylate) is an ingestion and contact py rethroid insecticide and acaricide currentl y registered for use on fruit s , vegetables, field crops, and ornamental plants for the control of various insect pests and mites.Fenpropathrin Summary of Analytical Chemistry and Residue Data D368340

Page 2 of 20 Under PP# 9E7594, the Interregional Research Project Number 4 (IR
- 4) propos ed 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, D anitol® 2.4 EC S pray (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 day s and a 1
- day preharvest interval ( PHI ) are proposed. The 2.4 lb/gal EC formulation is currentl y registered for use on tropical and subtropical fruits with inedible peel, including avocado, canistel, mang o, papaya, sapodilla, sapote (black, mamey), and star apple. T he 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. T he 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 0.0 29, 0.052, or 0.10 lb ai/A (0.032, 0.059, or 0.012 kg ai/ha) . T ea was harvested at 0
- to 14
- d ay PHI s. The following Good Agricultural Practice ( GAP ) information for India was provided: shoots along with bud are ty pically 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 an y countries other than India. No U.S. uses are proposed at this time.Fenpropathrin Summary of Analytical Chemistry and Residue Data D368340

Page 3 of 20 Tolerances for residues of fenpropathrin are established under 40 CFR §180.466 and are expressed in terms of fenpropathrin. T olerances 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 by products of poultry) to 2.0 ppm (milk fat reflecting 0.08 ppm in whole milk). Inthe previous risk assessment that was prepared for fenpropathrin (D313330, D. Dotson, 11/26/2008), HED recommended in favor of reassessed tolerances for cattle, g oat, 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 by products) be removed. The revisions have not been made to the 40CFR listing for fenpropathrin. The nature of the residue in plants is adequatel y 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 petitio n. An adequate gas chromatograph y method with electron capture detection (GC/ECD), Residue Method Number RM

- 22
- 4, is available for the enforcement of tolerances of fenpropathrin in crop commoditie s. The limit of detection (LOD) is 0.01 ppm. Inaddition, residues of fenpropathrin are completely

recovered through Protocol D of the FDA multiresidue m ethods
. Samples of guava, l ychee, sugar apple, and atemo yafrom the submitted tropical fruit field trials were anal yz ed using an adequate revised v ersion of the enforcement method which use s 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. S amples of dried black tea leaves from the tea field tri als were anal yzed for residues of fenpropathrin using adequate GC/ECD methods. The submitted crop field trial studies are supported by a dequate storage stability data. Adequate field trial data for guava, l yc hee, sugar apple, and atemoya were submitt ed 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 . T he submitted crop field trial d ata for guava, l ych ee, 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 toleran ce for guava also applies to f eijoa, 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 atemo ya 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,Fenpropathrin Summary of Analytical Chemistry and Residue Data D368340

Page 4 of 20 custard apple, ilama, and soursop. Th e Organization for Economic Cooperation and Development Maximum Residue L imit (OECD MRL) calculation procedures were used to determine the recommend tolerances. A dequate field trial data reflecting use of fenpropathrin on tea grown in India are availabl e for establishing an import tolerance on dried tea leaves. Th e OECD MRLcalculat ion procedures recommend that the tolerance be established at 3.0 ppm. However, there is a Codex MRLof 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 an y 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. Bec ause 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 l eaves 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 MRL s are established on the proposed tropical fruits. As a result, harmonization of tolerances is not an issue for the tropical fruits. A Codex MRLis established for residues of fenpropathrin in/on tea, green, black at 2 ppm. Using the OECD MRLcalculat ion procedures , the recommended tolerance for dried tea is 3.0 ppm. For purposes of harmonizatio n of the U.S. tolerance with the established Codex MRL , HED is recommend ing in favor of a tolerance of 2.0 ppm for dried tea. Currently , t olerances are established for residues of the pesticide chemical fenprop athrin (alpha

cyano - 3
- phenoxy

- benzyl 2,2,3,3

- tetrameth yl cyclopropanecarbox yl ate) in or on the commodities in 40CFR §180.466. Th is tolerance expression needs to be revised as follows: “T olerances are established for residues of fenprop athrin including its metabolites and degradates, in or on the c ommodities in the table below. Compliance with the tolerance levels specified below is to be determined b y measuring only fenprop athrin (alpha

- cyano - 3
- phenox y - benzyl 2,2,3,3

- tetrameth yl cyclopropanecarbox yl ate)
. **Regulatory Recommend ations and Residue Chemistry Deficiencies**  HED has examined the residue chemistry database for fenpropathrin. Pending submission of a revised Section F , the r e 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.Fenpropathrin Summary of Analytical Chemistry and Residue Data D368340

Page 5 of 20 **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 n o U.S. registration on tea, dried, a s of [date of FR notice].” 860.1550 Proposed Tolerances

 The tolerance expression proposed b y the petitioner should be revised to remove the re ference 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 f or tea should be revised to reflect the correct commodity definition: “Tea, dried.”Fenpropathrin Summary of Analytical Chemistry and Residue Data D368340

Page 6 of 20 **Background** The chemical structure and nomenclature of fenpropathrin are presented in Table 2 , and the phy sicochemical properties of the technical grade chemical are pr esented in Table 3
. **Table 2**  **. Fenpropathrin Nomenclature** Chemical structure

Common name Fenpropathrin Com pany 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)methyl ester 2,2,3,3
- tetramethyl

- cyclopropanecarboxyl ic acid CAS registry number 39515
- 41
- 8 End

- use product (EP) 2.4 lb/gal EC formulation (Danitol ® 2.4 EC Spray; EPA Reg. No. 59639
- 35) **Table 3**  **. Physicochemical**  **Properties of Fenpropathrin**

Parameter Value Reference Melting P oint/Range 45
- 50oC (113

- 122oF) DP# 315918 , 9/20/05 , W. Cutchin pH 4
- 5 (1% emulsion) Density g/cm 3 1.103 Water S olubility (25oC) 0.33 ppm Solvent S olubility (mg/L at 25oC) Xylene, cyclohexanone: 1000 Methanol: 337 Vapor P ressure at 25oC 5.5 x 10 - 6 ( 0.730 mPa ) Dissociation C onstant, pK a NA Octanol/W ater P artition C oefficient, Log(KOW ) 5.1 UV/V isible A

bsorption S pectrum 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 ® 2.4 EC Spray ; EPA Reg. N o. 59639
- 35). The label includes use directions for a number of fruit, vegetable, and field crops that are already register ed. Danitol ® is currentl y 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. O O CN O C H 3

C H 3 C H 3 C H 3Fenpropathrin Summary of Analytical Chemistry and Residue Data D368340

Page 7 of 20 **Table 4**  **. Summary of Directions for Use of**  **Fenpropathrin** Applic. Timing, Ty pe, and Equip. Form

ulation [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, B iriba, 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) A erial (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. T he use directions for the proposed tropical and subtropical fruit s are identical to those for the registered tropical and subtropical fruit s , 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 a ppli ed through an y typ e of irrigation s ys tem , and that tank mixing or use of the product with an y other product which is not specificall y 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 rotatio nal 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, l ychee, 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, l ychee, and sugar apple/atemo ya or in the avocado field trials previously submitted to support use on the re gistered 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 , 10/23/84Fenpropathrin Summary of Analytical Chemistry and Residue Data D368340

Page 8 of 20 The nature of the residue in plants is adequatel y understood based on acceptable metabolism studies conducted on apple, cotton, p into beans, and tomatoes. The residue of concern is the parent compound fenpropathrin. **860.1300 Nature of the Residue -**  **Livestock** There are no livestock feedstuff s associated with the proposed use on tropical fruits
. Therefore, data requirements for li vestock 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 C 18 Sep Pak chromatograph y, and analy zed 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 Analy tical Manual Vol. II
. Data collection methods: Samples of guava, l ych ee, sugar apple, and atemoya from the tropical fruit field trials were analyzed using a revised version of the enforcement method
. Inaddition to minor modifications to the original method, the revised method uses GC/MS

- SIM analy si s 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 lay er wa s partitioned twice with hexane. The resulting aqueous phase was discarded, and the hexane lay er 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 dry ness, redissolved in hexane, and applied to a silica gel column
. R esidues were eluted with ether:hexane (1:5, v:v). The eluate was evaporated to dry ness, redissolved in methanol, and applied to a C 18 Sep Pak cartridge . R esidues were eluted with methanol. The eluate was evaporated to dry ness and redissolved in hexane for GC/MS

- SIM anal ys is. The method was adequate for data collection based on acceptable method valid ation 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, l ychee, and sugar apple/atemo ya, respectively
. T he LLMV was 0.02 ppm for all matrices. Samples of dried black tea leaves from the tea field trials were anal yz ed for residues of fenpropathrin using GC/ECD methods. Slightly different methods were used for analy sis of samples from trials conducted in different locations. Briefl y, 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.Fenpropathrin Summary of Analytical Chemistry and Residue Data D368340

Page 9 of 20 The hexane layer was passed through sodium sulf ate and evaporated to dryness, then redissolved in hexane, and partitioned with ACN

- saturated hexane. The ACN layer was evaporated to dry ness, redissolved in hexane, and applied to a Florisil column . R esidues were eluted with 6% diethyl ether in hexane. The resulting eluate was concentrated to dry ness and diluted with hexane for analy sis by

GC/ECD. The L OQ, based on reported residue results, was 0.05 ppm
. T he reported limit of detection was 0.005 ppm. Samples from the Assam trial were reh ydrated in di stilled 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 analy sis by GC/ECD. The reported limit of quantit ation 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 . T he fortification levels for concurrent recovery did not encompass residues found in dried black tea leaves. Conclusions
. The residue anal yt ical 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 onl y limited data were provided for the anal yt ical methods used for analy sis 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 6/20 05) indicates that fenpropathrin is completely recovered b y 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 D 200755 , R. Cook , 11/21 /95 Residue Chemistry Memo D 160414, 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 f enpropathrin 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, orang es, 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 fiel d trials. The data demonstrate that residues of fenpropathrin are stable in/on fortified samples of guava, l ych ee, and atemoya storedFenpropathrin Summary of Analytical Chemistry and Residue Data D368340

Page 10 of 20 frozen for up to 243, 271, and 272 day s (8.0

- 8.9 months). No 0
- day data were provided in the concurrent storage stability study . S torage stability studies should alway s 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 duration s 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**  **Duration s of Sam** **ples 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 . N o corrections for decline during stor age are needed. Although onl y 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 pet itioner concerning the likel y duration of sample storage , and (2) the available storage stabilit y 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.Fenpropathrin Summary of Analytical Chemistry and Residue Data D368340

Page 11 of 20 **860.1480 Meat, Milk, Poultry, and Eggs** There are no livestock feedstuff s associated with the proposed use on tropical fruits or tea. Therefore, data requirements pertainin g 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 by products 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 by products) 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/atemo ya. Atemoya is a hy brid of sugar apple , and the two crops are considered to be identical for the purposes of generating residue data. Twe lve 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 F lorida and one was conducted in Hawaii. Li kewise, two o f the l ych ee trials were conducted in F lorida and one was conducted in Hawaii. Finally , two sugar apple trials were conducted in F lorida , and one atemo ya trial was conducted in H awaii
. At each test site, one untreated and one treated plot were establishe d. 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 gu ava, l ychee, 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 l ychee and one FL trial for sugar apple) . N o adjuvant was added to the spray

mixtures. Commercially mature fruit samples were collected 1 day after the second application. Samples of guava, l ych ee, sugar apple, and atemo ya were anal yz ed for residues of fenpropathrin using an adequate GC/MS

- SIM method
. The LLMV was 0.02 ppm for all matrices. Sample storage intervals and c onditions are reported in Table 5 . Adequate concurrent storage stability data were submitted to support the crop field trials.Fenpropathrin Summary of Analytical Chemistry and Residue Data D368340

Page 12 of 20 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, respectivel y, in/on six samples each of guava, lychee, and sugar apple/atemoya harvested at a 1

- day PHIfollowing 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, respectivel y, 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, l yc hee, and sugar apple/atemoya are adequate. Trials were conducted according to the proposed use pattern, samples were anal yz ed for residues of fenpro pathrin 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 i s the major production region for tropical crops in the United States
. T he number s of fi eld trials for each crop are not strictl y in accordance with OPPTS 860.1500 for the three crops
. Table 1 re commend s one trial with four treated samples each for atemoya and l ych ee, 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 equall y 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 f or guava, lychee, and sugar apple/atemoya may be translated to support uses and tolerances on the following tropical fruit crops as follow s : (1) guava uses/tolerances may be translated to feijoa, jaboticaba, wax jambu, starfruit, passionfruit, and acerol a; (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, l yc hee, and sugar apple/atemoya data support t olerances 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, cherimo ya, cust ard apple, ilama , and soursop. Refer to Attachment 1 for the tolerance calculation s . The registrant needs to submit a revised Section F in which the recommended tolerances are proposed.Fenpropathrin Summary of Analytical Chemistry and Residue Data D368340

Page 13 of 20 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 t ypicall y 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 doubl e 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 agricultu ral 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) . O ne 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 f i e ld phase of the studies. No information was provided concerning weather or crop maintenance procedures, and onl y 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 N adu, four trials were conducted: two during the wet season and two during the dry

season. Ineach 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). Sample s 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 day s. 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 anal yz ed for residues of fenpropathrin using acceptable GC/ECD method s , with an apparent LOQ of 0.05 ppm for Tamil Nadu samples and 0.02 ppm fo r 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. Res ultsFenpropathrin Summary of Analytical Chemistry and Residue Data D368340

Page 14 of 20 were also provided for samples harvested at PHIs of 0, 1, 3, 5, 10, and 1 4 day s for tea harvested from the trials conducted in Tamil Nadu. R esidues 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 R**  **esidue 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 anal ys is results provided by The Tetley Group, ShanShan Tea, and Finlay Tea for fenpropathrin residues in tea. The data provided b y the Tetley Group contained the results from anal ys es of black, green, oolong, and white tea in commercial shipments from India (n=151), Bangladesh (n=2), Sri L anka (n=3), China (n=12), Vietnam ( n=4), Indonesia (n=13), Papua New Guinea (n=2), Argentina (n=3), Ken ya (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 b y ShanShan Tea contained a summary

of the results of the anal ys es 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 s amples) from 2006

- 2008 . Re sidues 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
.Fenpropathrin Summary of Analytical Chemistry and Residue Data D368340

Page 15 of 20 T h e 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 0.0 3 to 0.10 lb ai/A (0.0 3 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 ~12 x) than those observed in commercial shipments of tea from various countries tested in 200 6
- 2009. Samples were anal yz ed for residues of fenpropathrin using tentatively acceptable analy tical method s , 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 export ers 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 actuall y major tea producers, three tea trials would be required from Argentina, China, and India (1 trial each) to support a world

- wide use o f 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 calculat ion procedures , the recommended tolerance for dried tea would be 3.0 ppm. A Codex MRLis 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 b e 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 Referenc e Standards**  An an al yt ical reference standard for fenpropathrin is currentl y available in the EPA National Pesticide Standards Repository ( electronic communication , Teresa Cole, 6/1 /20 1 2 ). 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.Fenpropathrin Summary of Analytical Chemistry and Residue Data D368340

Page 16 of 20 **860.1550 Proposed Tolerances** Tolerances are est ablished 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 ” s hould be removed. A Codex M RLis established for residues of fenpropathrin in/on tea, green, black at 2 ppm. No Canadian MRL s are established, and no Mexican MRL s are established for the crops in this peti tion. Adequate field trial data reflecting the proposed use pattern are avai lable for purposes of establishing tolerances on guava, l ychee, 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 MRLcalculat ion procedures w ere 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. A dequate field trial data reflecting use of fenpropathrin on tea grown in In dia 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 MRLcalculat ion procedures recommend a t olerance of 3.0 ppm for dried tea . H owever, for purposes of harmonization of the U.S. tolerance with the established Codex MRL , the recommend ed 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. T he experimental factor of 0.2% is consistent with fenpropathrin’s high octanol/water partition coefficient and low water solubility
. **References** PP # 4G3107 , Fenpropathrin (Danitol ® ) on c ottonseed. Evaluation of anal ytical m ethod and r esidue d ata , R. Loranger , 10/23/84 , MRID s 00126816
- 00126826 PP#7F3485/7H5527. Fenpropathrin (Danitol) on Apples and Pears. Evaluation of Anal yt ical 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 , 10/24/88Fenpropathrin Summary of Analytical Chemistry and Residue Data D368340

Page 17 of 20 D160414 , PP#1F3949 , Fenpropathrin (127901 Danitol) on Cotton, Grapes and Oranges. Evaluation of Anal yt ical Method and Residue Data. CB No. 7574 , M. Bradley , 1/29/92 , MRIDs: 4173400 1
- 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: 4242 9500 and 42429501 D208548 , PP # 2F04144/2H05648 , Fenpropathrin (127901 Danitol ® ) 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. Amendment s dated 9/1/94 and 5/16/95
. CB Nos. 14342, 14343, 15651, 15652 , R. Cook , 8/ 9 /95 , M RIDs: 43360500
- 43360503 , 43652400, and 43652401 D200755 , PP4F04327/FAP4H05690: Fenpropathrin (12790 1) on p eanuts. Evaluation of anal yt ical m ethods and r esidue d ata. 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 Analy tical 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 Anal yt ical 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 Pistachi o (Crop Group 14), Caneberries (Crop Subgroup 13

- 07A), Olives, Avocado, Black Sapote, Canistel, Mamey Sapote, Mango, Papaya, Sapodilla, and Star Apple. Summary of Anal yt ical 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 L imit Status S heet Attachment 2: Tolerance Assessment CalculationsFenpropathrin Summary of Analytical Chemistry and Residue Data D368340

Page 18 of 20 **Attachment 1 .**  **International Residue Limi t Status**  **S heet**  

### 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 180.4 66 Plant s /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 Il ama 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.Fenpropathrin Summary of Analytical Chemistry and Residue Data D368340

Page 19 of 20 **Attachment 2: Tolerance Assessment Calculations** For each of the crops listed below, the OECD MRL Calculator was used for calculating recommended tolerances. Average field tria l 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, l ych ee, 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, respec tivel y . 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 PHI s 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.Fenpropathrin Summary of Analytical Chemistry and Residue Data D368340

Page 20 of 20 **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/Ate mo**  **ya Tea**  **Region / Country Zo**  **ne 13/USA Zo**  **ne 13/USA Zo**  **ne 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 **Me an**  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 (m**  **g/kg) Residues** 

**(m g/kg)**  **Residues**

**(m g/kg)**  **Residues**

**(m g/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