Clofentezine Summary of Analytical Chemistry and Residue Data Barcode: D42 9732

Page 1 of 17 UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, D.C. 20460

OFFICE OF CHEMICAL SAFETY

AND POLLUTION PREVENTION

MEMORANDUM

Date: 10

- February

- 2016

Subject: CLOFENTEZINE : Revised Petition for the Establishment of Permanent Tolerances

and Registration for New Use on Avocado and Papaya and Crop Group/Subgroup Expansions for Pome Fruit, Group 11

- 10 ; Cherry Subgroup 12

- 12A ; Peach Subgroup

12

- 12B and Fruit, small, vine climbing, except fuzzy kiwifruit, Subgroup 13

- 07F, Summary of Analytical Chemistry and Residue Data.

PC Code: 12 5 501 DP Barcode No. : D 429732

Decision No.: 495217 Registration No s

. : 74054

- 1, 66222

- 47

Petition No.: 4E8312 Regulatory Action: Section 3 R egistration

Risk Assessment Type: NA Case No.: 7602

T XR No.: N A CAS No.: 74115

- 24

- 5

MRID No.: 49446901 40 CFR § 180. 446

From: P. Yvonne Barnes, Chemist

Risk Assessment Branch VI Health Effects Division ( HED; 7509P)

Through: Michael A. Doherty, Ph.D., Senior Chemist

Meheret Negussie, Chemist Chemistry Science Advisory Council

and

D onna S. Davis

, A cting Chief

Risk Assessment Branch VI

HED (7509P)

To: Evisabel Craig, Toxicologist and Risk Assessor

Risk Assessment Branch V I

HED (7509P)

and Andrew Ertman/Barbara Madden, RM 05 Risk Integration, Minor Use, Emergency Response Branch Registration Division ( RD; 7505P)Clofentezine Summary of Analytical Chemistry and Residue Data Barcode : D 429732

Page 2 of 17 OCSPP 860

Series Guideline MRID

Number Title

1500 49446901 Barney, W. (2014) Clofentezine: Magnitude of the Residue on Avocado. Study

No. 09321. Laboratory Identification Number: 09321.12

- CAR04. Unpublished study prepared by IR

- 4. 118 pClofentezine Summary of Analytical Chemistry and Residue Data Barcode : D 429732

Page 3 of 17 Table of Contents

1.0 Executive Summary

................................ ................................ ................................ ................ 4

2.0 Regulatory Recommendations

................................ ................................ ................................ 5

2.1 Deficiencies/Data Needs

................................ ................................ ................................ .. 5

2.2 Tolerance Considerations

................................ ................................ ................................ . 5

2.2.1 Enforcement Analytical Method

................................ ................................ ............... 5

2.2.2 Recommended Tolerances

................................ ................................ ........................ 5

2.2.3 Revisions to Petitioned For Tolerances

................................ ................................ .... 6

2.2.4 International Harmonization

................................ ................................ ..................... 6

2.3 Label Recommendations

................................ ................................ ................................ .. 6

3.0 Introduction

................................ ................................ ................................ ............................. 7

3.1 Chemical Identity

................................ ................................ ................................ ............. 7

3.2 Physical/Chemical Characteristics

................................ ................................ ................... 7

3.3 Pesticide Use Pattern/Directions for Use (860.1200)

................................ ....................... 8

4.0 Metabolite/Degradate Residue Profile

................................ ................................ .................... 9

4.1 Nature of the Residue

................................ ................................ ................................ ....... 9

5.0 Residue Profile

................................ ................................ ................................ ........................ 9

5.1 Residue Analytical Methods (860.1340)

................................ ................................ .......... 9

5.1.1 Multi

- Residue Methods (860.1360)

................................ ................................ ........ 10

5.1.2 Tolerance Enforcement Methods

................................ ................................ ............ 10

5.1.3 Submittal of Analytical Reference Standards (860.1650)

................................ ...... 10

5.2 Storage Stability (860.1380)

................................ ................................ .......................... 10

5.3 Residue Data

................................ ................................ ................................ .................. 11

5.3.4 Processed Food and Feed (860.1520)

................................ ................................ ..... 12

5.3.5 Meat, Milk, Poultry and Eggs (860.1480)

................................ .............................. 13

5.3.6 Food Handling (860.1460)

................................ ................................ ...................... 13

5.3.7 Water, Fish, and Irrigated Crops (860.1400)

................................ .......................... 13

6.0 Tolerance Derivation

................................ ................................ ................................ ............ 13 Appendix B. Field Trial Geographic Distribution for Avocado

................................ .................. 15 Appendix C. Stability of Clofentezine Residues in Avocado

................................ ...................... 16 Appendix D. OECD MRL Calculator Results for Clofentezine in/on the Avocado

................... 17Clofentezine Summary of Analytical Chemistry and Residue Data Barcode : D 429732

Page 4 of 17 1.0 Executive Summary

Clofentezine (3,6

- bis (2

- chlorophenyl)

- 1,2,4,5

- tetrazine) is an acaricide that is currently registered as a suspension concentrate formulation for use on almonds, apples, apricots, cherries, Christmas trees, grapes, nectarines, ornamentals (greenhouse and outdoor), peaches, pea rs, persimmons, and walnuts.

Interregional Research Project, Number 4 (IR

- 4) in cooperation with Makhteshim Agan of North America, Inc., has submitted a S ection 3 registration request for a new use in/on avocado and papaya. Furthermore, IR

- 4 has propos ed expanding the existing tolerances to cover additional commodities that are included in the revised crop group/subgroups 11

- 10, 12

- 12A, 12

- 12B, and 13

- 07F.

IR

- 4 has submitted field trial data for clofentezine on avocado. Five field trials were

cond ucted in the United States during the 2012 growing season in a manner matching the proposed use pattern for avocado and papaya

. The treated plot received a single foliar directed application of a 4 lb s a.i/gal suspension concentrate (SC) formulation of cl ofentezine at 0.251

- 0.256 lb a.i/A , and avocados were harvested 2

- 4 days after the application

. The residue trials are supported by adequate analytical method and storage stability data. Quantifiable residues were found in/on the avocado raw agricultura l commodities (RACs) , and recommended tolerance

level of 0.30 ppm was obtained using the Organization for Economic Cooperation and Development (OECD) calculation spreadsheet procedures. HED will extrapolate the avocado clofentezine tolerance to papaya ( Chem istry S cience A dvisory C ouncil , (ChemSAC, 07/30/2014). The number and geographic representation of the field trials are adequate.

No new data was submitted to support the proposed crop group/subgroup expansions. Available data on representative comm odities for each crop group or crop subgroup, including processing studies, are adequate to support the petitioned expansions.

There are no animal feed crops associated with the proposed new uses on avocado and

papaya , nor any new animal feedstuffs associ ated with the expansion of uses to crop

group s /subgroups; consequently, the established tolerances for residues in livestock commodities are adequate

. Therefore a discussion of the livestock metabolism is not required to address these petitions.

The metab olic fate of clofentezine residue s in plants (fruit crops only) is adequately

understood. In fruit crops, the residue of concern (ROC) is the parent, clofentezine

, for tolerance enforcement and risk assessment purposes

.

There is an adequate analytical enforcement method available to enforce the proposed

tolerances

. Multiresidue methods in FDA’s analytical method (PAM

- I) were found to be inadequate for tolerance enforcement due to poor recoveries.

Analytical reference standards for clofentezine (expir es 10/25/2015) are currently available at the EPA National Pesticide Standards Repository.

T he US grape tolerance covering the expanded f ruit, small, vine climbing, except fuzzy kiwifruit, subgroup 13

- 07F established at 1.0 ppm if changed would create expo r t issues withClofentezine Summary of Analytical Chemistry and Residue Data Barcode : D 429732

Page 5 of 17 Japan and Korea that m aintain a grape MRL at 1.0 ppm

. The US grape tolerance will remain at

1.0. However, m aintaining the US grape tolerance at 1.0 ppm does not harmonize with the Codex MRL of 2.0 ppm.

2.0 Re gulatory R ecommendation s

HED has examined the residue chemistry database for clofentezine

. There are no residue chemistry data deficiencies that would preclude the establishment of permanent tolerances for

residues of clofentezine in/on avocado, papaya and the proposed crop subgroup/ group expansions as outlined in Table 2.2. 2.

A human

- health risk assessment will be prepared as a separate document.

2.1 Deficiencies /Data Needs

No residue chemistry data deficiencies have been noted relative to these petitioned a ctions.

2.2 Tole rance Considerations

2.2.1 Enforcement Analytical Method

A n HPLC analytical method for the determination of clofentezine residues in/on apples was submitted with PP# 3F3392 (MRID# 44202401). Briefly, fruit samples are extracted into

acetone and filtered. An aliquot of the extract is removed and partitioned with hexane. The organic extract is rotary evaporated to dryness then reconstituted in hexane for clean up through a silica solid phase extraction cartridge. The clofentezine is eluted from the silica, ev aporated to dryness, adjusted to the final volume and quantified using high performance liquid chromatography with UV detection at 268 nm. This method originally could detect 0.01 ppm clofentezine in apples but only 0.05 ppm in apple pomace. The method w as modified to enhance its limit of quantitation for apple pomace and had recoveries of 64 to 100% from fortifications of 0.01 ppm in apples and 69 to 83% from fortifications of 0.01 ppm in apple pomace.

Control samples showed no detectable residues. Met hod trials were conducted on apples at 0.5 and 1 ppm and on apple pomace at 10 ppm. The limit of quantitation (LOQ) and limit of detection (LOD) were determined to be 0.01 ppm and 0.003 ppm, respectively. A petition method validation (PMV) was successfull y completed by the EPA Analytical Chemistry Laboratory, and the method was found acceptable. HED concludes that the method is suitable for enforcement purposes. The limit of quantitation (LOQ) and limit of detection (LOD) were determined to be 0.01 ppm an d 0.003 ppm, respectively. A petition method validation ( PMV ) was successfully completed by the EPA A nalytical C hemistry L aboratory , and the method was found acceptable. HED conclude s that the method is suitable for enforcement purposes.

2.2.2 Recommended Tol erances

The tolerance expressions established under 40 CFR §180.446 comply with the HED Interim Guidance on Tolerance Expressions (S. Knizner, 05/27/2009); no revisions are

necessary

. A t olerance summary is presented in Table 2.2.2 below.Clofentezine Summary of Analytical Chemistry and Residue Data Barcode : D 429732

Page 6 of 17 Table 2.2.2 T olerance Summary for Clofentezine

Commodity Proposed

Tolerance (ppm) Recommended

Tolerance (ppm) Correct Commodity Definition/Comments

To be established under 40 CFR §180. 446 (a) General. (1) Cherry, subgroup 12

- 12A 1.0 1.0 Established tolerance for cherry (1.0 ppm)

should be removed from the 40CFR and replaced by this subgroup tolerance. Fruit, pome, group 11

- 10 0.5 0.5 0 Established tolerance for apple and pear (0.5 ppm) should be removed from 40CFR and replaced by this group tolerance. Peach, subgroup 12

- 12B 1.0 1.0 Established tolerance for peach should be removed from the 40CFR and replaced by this group tolerance. Fruit, small, vine climbing, except fuzzy kiwifruit, Subgroup 13

- 07F 1.0 1.0 Established tolerance for grape (1 ppm) should be removed from the 40CFR and replaced by this subgroup tolerance.

Avocado 0. 3 0. 3 0 Papaya 0.3 0.3 0

2.2.3 Revisions to Petitioned For Tolerances

N one

.

2.2.4 International Harmonization

The International Residue Limit (IRL) Status Sheet is attached in Appendix A. The

recommended tolerance for residues of clofentizine in/on avocado and papaya is 0.3 0 ppm based on the parent only. There are no Codex/Canadian MRLs on avocado and papaya. There are no US, Codex or Can adian harmonization issues for fruit, pome, group 11

- 10. There are no US and

Canadian harmonization is sues for peach, subgroup 12

- 12B. The US tolerance and Codex MRL are not harmonized on cherry, subgroup 12

- 12A and peach subgroup 12

- 12B. The Codex MRL was established at 0.5 ppm on stone fruits. The clofentezine residues in/on representative crops cherry and peach are greater than 0.5 ppm and would result a tolerance exceedance for US

growers.

T he US grape toler ance and its expansion to fruit, small, vine climbing, except fuzzy kiwifruit, subgroup 13

- 07F at 1.0 ppm does not harmonize with the Codex MRL of 2.0 ppm. The petitioner proposes to maintain the US grape tolerance at 1.0 ppm because several countries

incl uding Japan and Korea also maintain a n MRL at 1.0 ppm and it would create export issues i f

the US grape tolerance were to change.

2.3 Label Recommendations

The proposed labels are adequate and supported by data. No revision to the labels is required.Clofentezine Summary of Analytical Chemistry and Residue Data Barcode : D 429732

Page 7 of 17 3.0 Introduction

Clofentezine (3,6

- bis ( 2

- chlorophenyl)

- 1,2,4,5

- tetrazine ) is an acaricide that is used in plant protection products for the control of spider mites

. It acts primarily as an ovicide, but it has some activity against early motile stages of mites. Clofentezine is currently registered for use on almonds, apples, apricots, cherries, Christmas trees, grapes, nectarines, ornamentals (greenhouse and outdoor), peaches, pears, persimmons, and walnuts.

3.1 Chemical Identity

The chemical structure and nomenclature of clofentezine are shown in Table 3.1, and the physicochemical properties of the technical grade of clofentezine are given in T able 3.2.

Table 3

. 1 Clofentezine Nomenclature

Chemical Structure

Common Name Clofentezine

IUPAC name 3,6

- bis(2

- chlorophenyl)

- 1,2,4,5

- tetrazine

CAS Name 3,6

- bis(2

- chlorophenyl)

- 1,2,4,5

- tetrazine CAS Registry Number 74115

- 24

- 5

3.2 Physical/Chemical Characteristics

Clofentezine’s vapor pressure (9.75 x 10

- 10 mm Hg @ 25 °C) and Henry's Law Constant

0.168 Pa×m3/mol indicate that the compound is non

- volatile under field conditions. Clofentezine has a low solubility (34.2 mg/L) in water; however, clofentezine is fairly persistent in the environment. Based on the use pattern and environmental fate parameters, there i s the potential

for clofentezine to reach water resources. The octanol/water partition coefficient for clofentezine indicates that it may have the potential to accumulate into fatty tissues.

The physical/chemical properties of this active ingredient are summarized in the Table

3.2 below.

Table 3.2 Clofentezine Physical and Chemical Properties

Parameter Value

Molecular Weight 303.1 g/mol

Water solubility (20 °C) 2.9 x 10

- 2 mg/L

Vapor pressure (25 °C) 9.75 x 10

- 10 mm Hg

Henry’s Law Constant (25 °C) 0.168 Pa×m3/mol

Octanol/water partition coefficient (25 °C) log Kow = 3.1Clofentezine Summary of Analytical Chemistry and Residue Data Barcode : D 429732

Page 8 of 17 3.3 Pesticide Use Pattern/ Directions for Use (860.1200)

Clofentezine is formulated as a suspension concentrate containing 42% active ingredient or 1.0 lb active ing redient per quart (i.e., 4.0 lb s a

. i/gallon). Two end

- use products are registered: A pollo ® SC Ovicide/Miticide (EPA Reg. No. 66222

- 47) and Clofentezine SC (EPA Reg. No. 66222

- 53). Clofentezine is applied at the first sign of mites by ground equipment through airblast, groundboom machinery, and handheld equipment once per year. It may not be

a pplied aerially or through any type of irrigation system. There are no registered residential uses

for clofentezine.

The Section 3 registration requested by IR

- 4, in cooperation with the registrant, Makhteshim Agan of North America, I nc . proposes the u se of A pollo ® SC Ovicide/Miticide on avocado, papaya, as well as the following crop subgroups : cherry subgroup (12

- 12A), peach subgroup (12

- 12B), pome fruit group (11

- 10), and small fruit vine climbing except fuzzy subgroup (13

- 07F). The new uses and crop group/ subgroups have the same maximum rate (0.25 lb a.i/A on orchard type crops) and the same pre

- harvest interval ( PHI ) as the previously registered crops. The PHI for avocado and papaya is 3 days. The PHI for the pome fruit group is 45 days. The PHI f

or the cherries, small fruit, vine climbing except fuzzy kiwi and peaches is 21 days and (10 days for peaches in California). The proposed uses and application rates are

further described in Table 3.3.

Table 3.3. Summary of Directions for Proposed Use for Clofentezine

APOLLO ® Suspension Concentrate (SC)

- E PA Reg. No. 66222

- 47

- 4 lbs

. a.i/gal

Application. Equipment Crop Maximum Application Rate PHI (days) Use Directions and Limitations

Airblast, Groundboom,

and Handheld Equipment Avocado

8 oz. product/A

0.25 lb a

. i/A 3 Do not apply via aerial or chemigation. Do not make more than one applications of product per year. PPE includes baseline attire (a long

- sleeved shirt and long pants, and shoes plus socks) and gloves. Do not graze livestock

in treated areas or harvest the

cover crop for livestock feed. Papaya Fruit, pome, group 11

- 10 45

Pears and Asian pear 21

and (10 days

Peaches California) Fruit, small, vine climbing, except fuzzy kiwifruit, subgroup 13

- 07F Cherry, subgroup 12

- 12A
Peach, subgroup 12

- 12B

Con clusio ns : The petitioner has requested that existing uses be expanded to pome fruit group 11

- 10, cherry subgroup 12

- 12A, peach subgroup 12

- 12B, and fruit, small, vine climbing, except fuzzy kiwifruit, subgroup 13

- 07F. The existing directions for use for these crops are unchanged other than the additional crops covered by the u pdated groups/subgroups. The use directions applicable to the avocado is translated to the papaya. The labels are adequate to evaluat e the residue chemistry data relative to the petitioned crop subgroup s /group s actions.Clofentezine Summary of Analytical Chemistry and Residue Data Barcode : D 429732

Page 9 of 17 4.0 Metabolite/Degradate Residue Profile

4.1 Nature of the Residue

DP Barcode D 247526 and D25 1 946 , Jennifer Rowell, 04/02/1999

No new metabolism data was submitted or required to support this petition.

The nature of the residue has been adequately delineated in fruit crops for Clofentezin e

. In fruit crops, the residue of concern is the parent, Clofentezine (A. Smith, 0 4/26/1988; RCB Nos. 3190 and 3191). Table 4. 4 provides a summary.

Table 4. 4 Summary of Metabolites and Degradates to be included in the Risk Assessment and Tolerance Expression

Matrix Residues included in Risk Assessment Residues included in Tolerance Expression

Plants Primary Crop Clofentezine Clofentezine Drinking Water Clofentezine Not Applicable

1 Livestock residues of concern are not considered in this action.

5.0 Residue Profile

5.1 Residue Analytical Methods (860.1340)

49446901. der

Samples were analyzed for residues of Clofentezine using high performance liquid chromatography with tandem mass spectrometry detection (LC/MS/MS).

Briefly, samples were extracted twice with acetonitrile (ACN), then centrifuged and filtered. The extracts were combined and reduced by rotary evaporation. Following the addition

of acetone, the extract was purified by sequential solid phase extraction on Strata

- X, amino (NH2), and CUCARB cartridges. Residues were eluted through the Strata

- X and amino cartridges with acetone, and were eluted from the CUCARB cartridge with 20% benzene in dichloromethane. The eluate was evaporated to dryness and re

- dissolved in acetone: ACN (50:50, v: v) for LC/MS/MS analysis.

The LOQ (determined as the lowest level of method validation, LLMV ) was 0.02 ppm

for c lofentezine, and the experimental LOD was 0.003 ppm. We note that the petitioner also presented calculated values for the LOD and LOQ based on the recoveries obtained at the 0.02

- ppm fortification levels. The LOD was calculated by multiplying the standard deviation of

recovery measurements a t the LLMV by the one

- tailed t

- statistic (confidence level not reported) for six replicates, and the LOQ was defined as 3 X the LOD. The calculated LOD was 0.003

ppm, a nd the calculated LOQ was 0.01 ppm.Clofentezine Summary of Analytical Chemistry and Residue Data Barcode : D 429732

Page 10 of 17 Method performance was evaluated during method valid ation and by use of concurrent recovery samples. For method validation and concurrent recovery, samples of untreated avocado

were fortified with c lofentezine at 0.02, 0.1, and 1 ppm. Recoveries were within the range of 70

- 120 %. The fortification levels bracketed the measured residues. Concurrent recoveries were not corrected for apparent residues in controls.

Conclusion s : The analytical method used for the residue trials was adequate ly validated for purposes of data collection.

5.1.1 Multi

- Residue Meth ods (860.1360)

DP Barcode D247526 and D25 1 946, Jennifer Rowell, 04/02/1999

Multiresidue methods in FDA’s analytical method (PAM

- I) were found to be un

acceptable for tolerance enf orcement (due to poor recoveries ).

5.1.2 To lerance Enforcement Methods

See Section 2.2.1.

5.1.3 Submittal of Analytical Reference Standards (860. 1650)

A nalytical standard s of clofentezine and its regulated metabolite are available ( e xpir es 10/25/2015) at the National Pesticide Standards Repository. A s reminder to the petitioner,

sup plies of analytical standards must be replenished as requested by the repository as long as the tolerance is published in 40 CFR180. 446 . The address is as follows:

USEPA National Pesticide Standards Repository/Analytical Chemistry Branch/OPP 701 Mapes Road Fort George G. Meade, MD 20755

- 5350

(Note : all mail will be returned if the extended zip code is not used.)

5.2 Storage Stability (860.1380)

49446901 . der

The submitted storage stability study indicated that s amples of avocado were stored

frozen for a maximum of 205 days ( ~ 6.7 months) from harvest to extraction. Samples were extracted and analyzed on the same day. To support sample storage durations, a concurrent storage stability study was conducted along with the field trial study

. The 229

- day in terval was the only data point provided. No 0

- day data were provided , such that the initial concentration is

unknown at (e.g., time zero) 0

- day. Storage stability studies should always include a 0

- day sampling interval to establish the residue levels prese nt at the time samples are placed into storage [see OCSPP 860.1380(d)(6)(i)]. However acceptable storage stabilty data are available for the storage duration for the avocado. Th ese data demonstrate that residues of clofentezine

were stable to cover avocad o stored frozen for up to 229 days ( ~ 7.5 months).Clofentezine Summary of Analytical Chemistry and Residue Data Barcode : D 429732

Page 11 of 17 Available storage stability data have shown that clofentezine residues are stable in apples for up to 381 days (Memo, M. J. Bradley, August 17 , 1 994; PP#:6F3392/6H5500), in peaches for up to 2 years (Memo, R. Griffin, 05/ 22 / 1990; PP#:9F3699) and in almonds for one year (Memo, M. Bradley, 08/ 15 / 1 990 ; PP#:9F3793). Based on these data, HED conclude d that residues of clofentezine are stable in grapes and persimmons for up to one year of frozen storage.

A previously reviewed evaluation of analytical methods and residue data of clofentezine for petition PP# 9F3793 (M. J. Bradley, March 0 7, 1990) determined that clofentezine was essentially stable in almond hulls for over two years, and fai rly stable in almond nutmeat for one year. An evaluation of analytical methods and residue data of clofentezine in/on peaches for petition PP# 9F3699 (F. Toghrol, April 21, 1989) determined that no significant degradation of clofentezine occurs in peaches when stored at ~15 °C for up to two years.

Conclusion s : Previously submitted storage stability data (i.e., apples, almonds, grapes, peaches and persimmons) support the storage condition s and duration s of the stored samples in the

avocado magnitude of the residue studies which is translated to papaya

. The se storage stability data are adequate to show that residues of clofentizine remain stable during frozen storage period s associated with the avocado residue trials

.

5.3 Residue Data

49446901

. der

Av o cado

Five field trials were conducted in the United States during the 2012 growing season in the North American Free Trade Agreement (NAFTA) Growing Zones 3 (FL; 1 trial) and 10 (CA; 4 trials). Each trial consisted of one untreated plot and one treated plot. A t each crop trial location, the treated plot received a single

, foliar

- directed application of a 4 lb s a

. i/gal suspension concentrate (SC) formulation (Apollo SC) of clofentezine at 0.251

- 0.256 lb a

. i/A. The crop field

trials from California have been ass essed for independence. Although the CA crop field trial

locations were less than 20 miles apart and of the same variety the initial application of the pesticide was off

- set by at least 30 days. HED concludes that these field trials are considered

separa te based on the timing of the pesticide application.

Applications were made using ground equipment in spray volumes of 60

- 230 gal s /A during the fruiting stage of development s amples of avocados were harvested at a PHI of 2

- 4 days after the application; ad ditional samples from one trial (CA21) were collected at 0, 7, 9, and

14

- day PHI s to assess residue decline. In avocados harvested 2

- 4 days following application

, residues (an d per

- trial averages) were 0.0376

- 0.127 ppm (0.0439

- 0.106 ppm).

Acceptable metho d validation and concurrent recoveries were reported for samples

fortified with clofentezine at 0.02

- 1 ppm, thus validating the method. The residue of concern for plants is clofentezine (parent only). The LOQ ( determined as the LLMV) was 0.02 ppm.

A summary of residue data for clofentezine in/on avocado is presented in Table 5.3

.Clofentezine Summary of Analytical Chemistry and Residue Data Barcode : D 429732

Page 12 of 17 Table 5.3 Summary of Residues from Avocado Field Trials with Clofentezine.
Crop

Matrix Analyte Total Application

Rate (lb a

. i/A) PHI

(days) n 1 Residues (ppm)

Min. 2 Max. 2 LAFT 3 HAFT 3 Median Mean SD 3

Avocado Clofentezine 0.251

- 0.256 2

- 4 5 0.0376 0.127 0.0439 0.106 0.0874 0.0847 0.0292

1 n = number of field trials.

2 Values based on total number of samples.

3 Values based on per

- trial averages. LAFT = lowest average field trial, HAFT = highest average field trial, SD = standard deviation.

Papaya

IR

- 4 petitioned to translate the available data from avocado to papaya. Avocado is being proposed as a representative crop for the new Crop Subgroup 24B, Tropical and Subtropical, Medium to Large Fruit, Smooth, and Inedible Peel. This proposal was brought to the ChemSAC.

The ChemSAC determined that th e translation of avocado data to papaya was appropriate

, provided the number of field trials and geographical locations w as adequate ( ChemSAC

07/30/2014 )

.

Crop G roup/ S ubgroup E xpansions

No new crop field trial data w ere submitted n or are any required because the existing residue data are adequate to support the petitioned actions. All crops included in the crop group/ subgroup expansions will be treated at the same rate and timing as the currently registered crops.

The proposed crop group/subgroups expansions are listed as follows: p ome f ruit, g roup 11

- 10 ;

c herry s ubgroup 12

- 12A ; p each s ubgroup 12

- 12B and f ruit, small, vine climbing, except fuzzy kiwifruit, s ubgroup 13

- 07F

.

Conclusion s : The submitted avocado residue data are adequate in terms of both number and geographic representation to support the new use on the avocado

. The residue decline data indicated that residues of clofentezine decreased with increasing PHI in/on avocados. The avocado residue data support a tolerance of 0.30 ppm for residues of clofentezine in/on avocado. Therefore, HED is recommending for a tolerance for residues of clofentezine in papaya at 0.30

ppm.

No new field trial data are required to support the requested tolerance group/subgr ou p expansions

.

5.3.4 Proces sed Food and Feed (860.1520)

DP Barcode D247526 and D25 1 946, Jennifer Rowell, 04/02/1999

Memo of H. Fonou ni, PP9F3705/9H5572, 12/15/1988

Processing studies for the currently registered clofentezine uses are adequate. Clofentezine processing studies are available for apples and grapes. The apple juice processing factor was also translated to pear juice.

Conclusion : Processing studies f or the currently registered clofentezine uses are adequate. No processing food or feed is associated with the requested new use s ( avocado and papaya)

,

moreover , there are no processing studies required for papaya (dried, j uice) , cherry, apple (dried) , pear (dried) or peach (dried)

. Associated with the expanded crop group /subgroups are processing stud y require ments for grape (juice

, raison) and apple (juice).Clofentezine Summary of Analytical Chemistry and Residue Data Barcode : D 429732

Page 13 of 17 5.3.5 Meat, Milk, Poultry and Eggs (860.1480)

DP Barcode D247526 and D25 1 946, Jennifer Rowell, 04/02/1999

There are no animal feed items associated with the new use s on avocado and papaya or with any new commodities as a result of crop group updating.

Conclusions: The currently established tolerances for residues of clofentezine in livestock commodities are thus adequate to support th is petition,

5.3.6 Food Handling (860.1460)

There are no petitioned uses that are relevant to this guideline topic.

5.3.7 Water, Fish, and Irrigated Crops (860.1400)

There are no petitioned uses that are related to this guideline topic

.

6.0 Tolerance Derivation

HED used the Organization for Economic Cooperation and Development ( OECD) MRL

calculat ion procedures to determine appropriate tolerance levels for the residues of clofentizine

. The results from the spreadsheet calculator support the proposed tolerances. The inputs and the outputs from the calculat or are shown in Appendix C. The data support a tolerance of 0.30 ppm for residues of clofentezine in/on avocado and papaya.

HED concu rs with the petitioner’s request to convert representative commodit y tolerances

to their respective crop group s or sub group per the petitioned request. HED's tolerance

recommendations are summarized in Table 2.2.2.Clofentezine Summary of Analytical Chemistry and Residue Data Barcode : D 429732

Page 14 of 17 Appendix A

. International Residue Limits Table

Summary of US and International Tolerances and Maximum Residue Limits Residue Definition :
US Canada Mexico 2 Codex

40 CFR 180.446: Clofentezine

Plant: Clofentezine

Livestock: Clofentezine and 3

- (2

- chloro

- 4

- hydroxyphenyl)

- 6

- (2

- chlorophenyl)

- 1,2,4,5

- tetrazine metabolite Plant: Clofentezine

Livestock and dairy: 3,6

- bis(2

- chlorophenyl)

- 1,2,4,5

- tetrazine, including the metabolite

3

- (2

- chloro

- 4

- hydroxyphenyl)

- 6

- (2

- chlorophenyl)

- 1,2,4,5

- tetrazine Plant commodities:

clofentezine

Animal commodities: sum of clofentezine,

and all metabolites containing the 2

- chlorobenzoyl moiety, expressed as

clofentezine

The residue is fat

soluble.

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

US Canada Mexico 2 Codex

Avocado 0.3 Papaya 0.3 Fruit pome group 11

- 10 0.5 0.5 apple, pear 0.5
Cherry, subgroup 12

- 12A 1.0 0.5 stone fruits
Peach, subgroup 12

- 12B 1.0 1 .0 nectarine, peach

Fruit, small, vine climbing, except fuzzy kiwifruit, Subgroup 13

- 07F 1.0 2.0 grapes, dried grapes = ( currants, raisins and sultanas) Completed by: M. Negussie

, 05/11/ 20 15

1 Includes only commodities of interest for this action. Tolerance values should be the HED recommendations and not those prop osed by the applicant.

2 Mexico adopts US tolerances and/or Codex MRLs for its export purposes.Clofentezine Summary of Analytical Chemistry and Residue Data Barcode: D423333

Page 15 of 17 A ppendix B

. Field Trial Geographic Distribution for Avocado

Trial Num bers and Geographical Locations

NAFTA Growing Zone s Total Number Crop Number of Trials 3 10

Avocado Sub mitted 1 4 5
Required 1 1 4 5

1 As per Table 5 of OCSPP guideline 860.1500 for avocado.Clofentezine Summary of Analytical Chemistry and Residue Data Barcode : D 429732

Page 16 of 17 Appendix C

. Stability of Clofentezine Residues in Avocado

Stability of Clofentezine Residues in Avocado.

Commodity Spike

Level (ppm) Storage interval

(days) Fresh Fortification

Recoveries (%) [Avg.] Stored Sample

Recoveries (%) Mean

Recovery (%) Corrected %

recovery 1

Avocado 0.1 229 79, 84, 87 [83] 52, 58, 51 54 64Clofentezine Summary of Analytical Chemistry and Residue Data Barcode : D 429732

Page 17 of 17 Appendix D

. OECD MRL Calculator Results for Clofentezine in/on the Avocado

Tolerance values were calculated by the OECD MRL Calculator using data from the avocado

field trial residue study ( MRID 49446901 ) for a 0.25 lb a

. i/A clofentezine use rate and a 3

- day

PHI for the A vocado :

CLOFENTEZINE

AVOCADO Country U.S.A 3 day s PHI/ 0.25 lb a.i.

Total number of data (n) 5 Percentage of censored data 0%

Number of non

- censored data 5

Lowest residue 0.044 Highest residue 0.110

Median residue 0.100

Mean 0.087 Standard deviation (SD) 0.029 Correction factor for censoring (CF) 1.000

Proposed MRL estimate

- Highest residue 0.110

- Mean + 4 SD 0.203

- CF x 3 Mean 0.260

Unrounded MRL 0.260

Rounded MRL 0.3

High uncertainty of MRL estimate. [Small dataset]

Residues (mg/kg) n

0.044 1

0.069 1

0.1 1

0.11 2