Page 1 of 20

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. 
Fenpropathrin Summary of Analytical Chemistry and Residue Data D368340

Page 2 of 20

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® 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. 
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. 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, 
Fenpropathrin Summary of Analytical Chemistry and Residue Data D368340

Page 4 of 20

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 (alphacyano-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.
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 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.”
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 

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®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/cm31.103

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®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®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.

O

O

CN O

CH3

CH3

H3C CH3
Fenpropathrin Summary of Analytical Chemistry and Residue Data D368340

Page 7 of 20

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
Fenpropathrin Summary of Analytical Chemistry and Residue Data D368340

Page 8 of 20

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. 
Fenpropathrin Summary of Analytical Chemistry and Residue Data D368340

Page 9 of 20

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 nhexane: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 
Fenpropathrin Summary of Analytical Chemistry and Residue Data D368340

Page 10 of 20

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.
Fenpropathrin Summary of Analytical Chemistry and Residue Data D368340

Page 11 of 20

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.
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, 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. HAFT1 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.
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 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 
Fenpropathrin 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 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. HAFT1 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. 
Fenpropathrin Summary of Analytical Chemistry and Residue Data D368340

Page 15 of 20

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.
Fenpropathrin Summary of Analytical Chemistry and Residue Data D368340

Page 16 of 20

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®) 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
Fenpropathrin 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 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®) 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
Fenpropathrin Summary of Analytical Chemistry and Residue Data D368340

Page 18 of 20

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 Mexico2 Codex3

40 CFR 180.466 

Plants/Livestock: fenpropathrin (alphacyano-3-phenoxy-benzyl 2,2,3,3-tetra

methylcyclopropanecarboxylate)

None fenpropathrin. The residue 

is fat-soluble.

Commodity1 Tolerance (ppm) /Maximum Residue Limit (mg/kg)

US Canada Mexico2 Codex3

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.
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 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.
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/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