Methoxyfenozide Summary of Analytical Chemi stry and Re sidue Data OP Barcode 0425285


### UN ITED STATES ENV IRO NMENTAL PROTECTION AGENCY WASHINGTON, D C 20460 OFF I CE OF C HEMICAL SA FETY AND POLL U TION PREVE N TI ON


### MEM ORAND UM DATE: 31March2015 SUB J EC T: Meth oxyfenozi d e. Petition to Establish Permanent Tolerances, and Associated Section 3 Re gistrat ion , for Residues Resulting from Use of th e Insecticide on Chives: and to Convert Stone Fruit Group 12 (Except Fresh Prune Plums) to Stone Fruit Group 1 2 -1 2 (Except Fresh Prune Plum s) , and Tree Nut Group 14 to Tree Nu t Group 14-12. 

### S umm ary of Anal ytical C h e mi s try and Re s idue Data. PC Co d e : I 21027 

### Deci s ion N umb er: 493332 

### P etiti o n: 4E8298 

### DP Barcode: D425285 

### R eg istration Number: 62719

-442 

### Reg ulatory Actio n: Section 3 

### C ase N umb er: 7431 

### Ri s k Assess m ent Type: NA 

### TXR N umb er : NA 

### CAS N umb e r: 161050-58-4 4 0 

### CFR: § 180.544 

### MR ID N umb er: 4942020 I 

### FROM:

THRU: and



### TO: William T. Drew , Chemist

# ~..) Risk Assessment Branch II (RAB2) H ealth Effects Di v ision (HED). 7509P Denni s M cNei lly , Chemist 

## Q_

# ~ <:- 

## M

# ~ RAB2/ H ED. 7509P 

## r/"'. (

. { Thurston Morton , Chemist 

## /'.?' 

# P 11 /**~** RAB4/ H ED. 7509 P.

# Chemi~~~ry Cou ncil (ChemSAC) D onald Wilbur , C hemist**\t!-M~** RAB3 / HED , 7509P , ChemSAC Barbara Madden and Andrew Ertman , RM Team 5 Min o r Use and Emergency Respo n se Branch (MUERB) Registration Di vision ( RD ). 7505P

Page 1 of 25Methoxyfenoz i de Summary of A n alytica l Chemistry and Residue Data DP Barcode D425285 T a bl e of Conten ts 1.0 Executive S umn1 a r y .. ................................ .. ... . .. .. ... . .. .. .. .. .. .. . .. .. .. . ... . .. .. . .. .. .. . .......................... 4 2
. 0 Regulatory Recommendations
. . .. .. .. .. .. .. .. .. .. .. .. .. .. .. . ............................. . .. .. . .. .. .. . ...... . ... . .. . ... . ... 5 2 .1 Data Deficienci es/ D ata Needs
.. .. .. ... . ... . ... . .. .. .. .. .. .. .. . ... . ... . .. .. .. . ... . .. . ... . .. . ... . .. . .. .. .. . .. .. .. . ... . .. . 6 2.2 T olerance Cons iderations
........................................................ . ......................................... 6 2
. 2 .1 Enforcement Analytical Method/Multiresidue Methods
.......................................... 6 2
. 2
. 2 Recommended Tolerances
............................ .. .. . ... . .. .. .. .. . .. ......... .. ............................. 7 2.2.3 Revisions to Petiti o ned-For Tole r ances . ...... ... . ... . .. .. . .. .. .. .. . .. .. ..... .. ...... . .. . ... . .. . ... . .. .. .. . 7 2.2.4 In tern ational Harmonizati on ..................................................................................... 8 2.3 Label Recommendations
.............. . ................................................................................... 9 2.4 S ubm ittal of Ana lytical Reference Sta nd ards (860
. 1650)
.. . .. .. .. . ... . .. .. .. . .. .. .. .. . .. ...... . .. .. . ... 9 3
. 0 Chen1i cal Id entity
................ .. . .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. . ... . .. .. .. .. .. . .. .. .. . ... . .. .. .. . .. . .. .. .. .. .. . .. .. .. .... 10 3 .1 Nomenclatu r e .. . .. . ... . .. .. .. . .. .. .. ... ..... ... . ................................................................. .... . .. .. .. . . 10 3.2 Physicochemica l C h aracteristics
................ . ... . .. .. .. .. .. .. . .. .. .. . .. .. ...... .. . .. .. ...... . ................... 10 3.3 Pesticide Use Pattern/Directions for Use (860.1200)
.. .. .. .. .. ..... .. .. .. . .. . ... .. . . .................... 11 4.0 Metabolite / Degradate Residue Profil e . ... . ... .. .. .. .. . ... . ... . ... . .. .. . .. .. .. .. . ... . .. . .. .. .. . ... . .. .. .. . .. . ... . .. .. 11 4.1 Nature of the Residue
. .. .. . .. .. .. .. .. .. .. .. .. .. .. .. .. .. . ... .. .. . ... . .. .. .. .. .. . .. .. .. . .. .. .. .. .. . .. . ... . .. . .. .. .. .. .. . .. . . 11 4
. 1
. 1 Summary of Plant and/ or Livestock Metabolism (860 .1 300)
. .. . .. .. .. .. .. . .. . ... . .. . ... . .... 12 4.1
. 2 Su mm ary of Confined Rotational Crops (860.1850)
............ .. ..... . ........................... 13 4
. 1
. 3 Summary of R at Metabo li s m ... .. .. .. .. .. .. . ... .. .. . ... . .. .. .. .. . .. .. .. .. .. . .. .. . ... . .. . .. .. .. . ... . ... . .. . .. .. 13 4
. 1.4 Summary of Environmental Degradation
. .. .. .. .. .. .. .. . ... . .. .. .. . ...... .. .. . .. .. .. . .. . ... . .. . ... . ... . 14 5
. 0 Residue Profile
.. . .. .. .. . ... . .. .. .. . ... . .. .. .. .. .. ... . .. .. .. .. .. . ... .. ... . ................................................. . .. .. . . 15 5
. 1 Residue Analyt ic al Methods (860.1340)
............................ . ......... . .. .. ........................... 15 5. 1.1 Data Collection Methods
. ... . ... . ... . .. .. .. .. ... . .. .. .. ......................................................... 1 5 5. 1 .2 Multi-Residue Me th ods (860. 1360)
. .. .. .. . ... .. .. .. . ...................................................... 16 5.1.3 Tolerance Enforcement Methods
..... .. .. .. .. .. . ... . ... . ... . .. .. .. . ... . .. .. .. . .. .. .. . .. .. .. .. .. . .. .. .. . .. .. . 16 5.2 Storage Stabi lity (860.1380)
........... .. .. .. .. .. .. .. .. .. .. .. .. . ... .. . .. .. .. . ... . .. . ... . .. . .. .. .. . ... . ... . .. .. .. . .. .. . 17 5.3 Residue Data
. . .. .. . ...... .. .. . ... . ... . ... . ... . ... . ... .. .. .. .. . ... .. . ...... .. .............................................. . ... 1 8 5.3. 1 Crop Field Tri a ls (860.1500)
....... . ... .. .. .. .. .. .. .. .. .. . ... . .. .. .. .. .. . .. .. .. . ... . .. .. .. . .. . ... . .. .. .. . .. .. . 18 5.3.2 Field Rotational Crops (860.1900)
.. .. . ... . ... .. .. . ... . ... . ... . .. .. .. . .. .. .. . .. .. .. . .. .. .. . .. .. .. .. . .. .. .. . 18 5
. 3
. 3 Processed Food and Feed (860.1520)
. ... . .. .. ... . .. .. .. .. .. .. .. .. . .. ..... .. .. .. . .. ..... .. .. .. .. . .. .. .. .. . 19 Page 2 of25Methoxyfenozide Summary of Analytical Chemistry and Residue Data DP Barcode 0425285 

### 5.3.4 Meat , Milk , Poultry and Eggs (860.1480)
.......................................................... .... 19 5.3.5. Food Handling (860.1460)
...................................................................................... 19 5
. 3
. 6 Water, Fish and Irrigated Crops (860
. 1400)
. .. . .. .. . .. .. .. . .. . .. .. . .. . .. .. . .. . .. . .. . .. . .. . .. . .. . .. . .. . 19 5.4 Food Residue Profile
............................................................................................. . ..... . .. 19 6.0 Tolerance Derivation
... . .. . .. . .. .. .. . .. .. .. .. . .. .. . ... . .. .. .. . .. .. .. . .. .. .. . .. . .. .. .. . .. . .. .. . .. . .. . .. .. . .. . .. . .. . .. . .. . .. . .. 20 References
. .............. . ..................................................................................................................... 20 Attachment 1: International Residue Limit Status
.. .. .. .. . .. .. . .. .. . .. .. . .. .. . .. . .. .. .. . .. . .. . .. . .. . .. . .. .. . . .. . .. .. . .. . 22 Attachment 2: O E CD Tolerance Assessment Calculations
......................................................... 24

Page 3 of 25Methoxyfenozide Summary of Analytical Chemistry and Re s idue Data DP Barcode D425285 1.0 Exec utive S umm ary Methoxyfenoz ide (with CAS name 3-methoxy

- 2 -methy lbenzoic ac id 2 -( 3,5-dimeth y lbenz oy l]- 2

- [ I , 1-dimethylethyl ] hydrazide) i s a diacylhydrazine insecticide used on a wide variety of food and feed crops for the control of lepidopterou s pest species. Permanent tolerances are established for residues of methoxyfenozide in or on a w ide variety of plant co mmod ities , at lev el s rangin g from 0.02 ppm in peanuts and tub ero us/ corm vegetab les (s ub gro up ID ), to 400 ppm in herb subgroup l 9A (40CF R § l 80 .544[a][ l ]). Permanent toleran ces are also estab li s he d for residues of meth oxyfenozid e in th e milk , meat and fat of live s tock (40CF R § 180.544[a][J]) , and for the co mbin e d res idu es of t he pare nt and its g lucuronide co nju gate ( RH-141 , 518) in eggs and meat by product s at 0
.0 2

- 0.40 ppm (40CFR § 180. 544[a][2])
. Add iti ona ll y , permanent tolerances for methox yfe noz ide are establi sh ed in hi gh-mo ist ure rotation a l cro p s (40CFR § 180.544[d][ 1 ]) , and for th e combined res idue s of the parent and it s metabolites RH-1 5 1,055, RH-15 2,0 72 and RH117 , 236 in low -mois ture rotational crops (40CFR § 180. 544[d] [2]). Inte rreg io nal Research Project # 4 ( IR-4 ) ha s submitted a petition ( PP#4E8298) proposing the use of methoxyfenozide as In trepid 2F (EPA Registratio n # 627 1 9-442) via foliar application o n c hi ves. T he end- u se product (EP ), In trep id 2F , is a flowable co ncen t rate (F IC ) fo rmulati o n co ntai nin g 2 pounds of act i ve ingred ient per gallon (lb ai/ gal). IR- 4 sub mitte d a pe titi o n requesting the establishment of a permanent t o lerance for re s idu es o f methoxyfenozide in or on fresh chive leaves. This proposed tolerance of 30.0 ppm in fresh c hi ves is s upp orted adequately by magnitude-of-residue data. A lthough o nl y data for fresh and dried c hi ves we re sub mitte d , severa l revi sed tol erances we re proposed. Fresh chives are c urre ntl y covered in green onion subgroup 3 -078 at a tol erance of 5.0 ppm. IR-4 proposed the exc lu s io n of fresh ch ives from subgroup 3-078 , and es tab li s hment of a separate tol erance at 30 .0 ppm. Herb s ub g roup l 9A is currently establi shed at 400 ppm with an exception for dried ch ives. IR-4 is propo s in g that the herb subgroup 19A toleran ce i s suffi c ie nt to cover dried chives, and th at th e exception for chives be re moved and replaced with an exce ption for fresh chives. IR-4 i s also proposing the conversion of tree nut group 14 to tree nut gro up 14-12 , and convers ion of s to ne f ruit gro up 12 excep t fresh prune plum to s ton e fruit gro up 12-1 2 except fresh prune plum
. Pending sub mi ss ion of a rev i sed Section F (to prop ose tolerances and correct commodity defi niti o ns as re co mmende d by H ED ), there are no r esidue c hemistry issues that woul d preclude estab li s hing the r eco mmended tol e ranc es . The spec ifi c res idu e chem istry findings are s ummarize d be low. 

### Crop Field Tria l s : C hi ve field trials we re conducted in th e USA durin g the 2012 growing seaso n. Three trial s were co nducted in Nort h A merican Free T rade Agreement (NAFTA ) Zones 2 (M D ; I tri a l) and 10 (CA; 2 trials). Fo llov.'1ng fo ur folia r app li cations of the 2 lb ai/gal FIC fo rmul a ti on of methoxyfenozide at a tota l seaso n al use rate of approximately 1. 0 lb ai per acre (lb ai/ A), re -treatment intervals ( RTl s) of 8-11 days , and a pre-harve s t inte r val (PHI) of 1 day,
Page 4of25Methoxyfenozide Summary of Analytical Chemistry and Residue Data DP Barcode D425285 

### maximum residues were 13 and 118 ppm in fresh and dried ch ive leaves, respectively. A residue decline study was not conducted. 

### Processing Study: The processed commodity for fresh chives is dried chiv es, although these are considered a raw agri cultura l commodity (RAC) under herbs and spices group 19. Samples of dried chives were produced at the field trial sites , and subsequently analyzed along with the fresh chive samples. 

### Residue Anal ytical Methods and Storage Stability: An 

### acceptable method was used for residue quantitation, and adequate data are available to support samp le storage durations and conditions
. Validated methods are available for the enforcement of methoxyfenozide tolerances. An 

### adequate method was used for the quantitation of methoxyfenozide residues 

### in samples from the chive field trials, based on acceptable method validation and concurrent recovery data. 

### Meat, Milk, Poultry and Eggs: The current action for the proposed use on chives (and updates of crop group 12 to group 12-12, and group 14 to gro up 14

- 12) do not require revisions to the existing tolerances in livestock commod it i es. 

### MRL Harmonization: Codex has not established maximum residue limits (MRLs) for methoxyfenozide in either green onions or herbs. Canada's Pest Management Regulatory Agency (PMRA) has an ex i sting MRL in various green onions/leeks at 5 mg/kg , which i s harmonized with the existing tolerance of 5.0 ppm in green onion subgroup 3-07B
. PMRA has an existing MRL in various fresh herbs at 80 mg/kg , which is not harmonized with the recommended tolerance of 400 ppm in herb subgroup l 9A , nor the recommended tolerance of 30 ppm in chjve. Codex ha s an ex isting MRL in stone fruit at 2 mg/kg, whi ch i s not harmonized with the recommended tolerance of3.0 ppm in stone fruit group 12-12 except fresh prune plum. PMRA has existing MRLs in various plums/ apricots/ jujubes/ sloes at 0.7 mg/kg, and in various cherries/peaches/nectarines at 6 mg/kg , neither of which is harrnoruzed with the recommended tolerance of3.0 ppm in stone fruit group 12-12 except fresh prune plum. Codex has an existing MRL 

### in tree nuts at 0.1 mg/kg, which i s harmonized w ith the recommended tolerance of 0. 10 ppm in tree nut group 14-12. PMRA has an existing MRL in a large variety of tree nuts at 0.1 mg/kg , which is harmonized with the recommended tolerance of 0.10 ppm in tree nut group 14-12.
2.0 Regulatory Recommendations HED has examined the residue chemistry database for methoxyfenozide. Pending submission of a revised Section F (to propose tolerances and commodity definitions as recommended by HED) ,
Page 5of25Methoxyfenozide Summary of Analytical Chemistry and Residue Data DP Barcode D425285 there are no res idu e chemistry issues that would preclude establishing the recommended tolerances. The recommended tolerances are li sted in Table 2.2.2 , below. Notes to RD: Upon establishment of the rec ommended tolerance in herb subgroup 19A, the existing tolerance in herb subgroup 19A except chive should be removed (40CFR 

### § l 80.544[a][ 1 ]). Upon establishment of the recommended tolerance in chive fresh leaves at 30 ppm (40CFR 

### § l 80.544[a][ I ]) , the existing tolerance for indirect or in advertent me thoxyfenozide residues in rotational crop chives at 4.5 ppm should be remov e d (40CFR 

### § l 80.544[d][2]). Upon estab li shment of the recommended tolerance in green on ion s ub group 3 -078 except chive fresh leaves , the ex is tin g tolerance in green on ion subgroup 3-078 shou ld be removed (40CFR 

### § l 80.544[a)[ I]). Upon estab li shment of the proposed tolerance in tree nut group 14-12, the existing tolerances in tree nut group 14 and pistachio should be removed (40CFR § l 80.544[a)[l])
. Upon establishment of the proposed tolerance in stone fruit group 12-12 except fresh prune plum , the existi ng tolerance in stone fruit group 12 except fresh prune plum should be removed (40CFR 

### § l 80.544[a](l]). 2.1 D a ta Deficiencie s/D a ta N eeds None. 2
. 2 Tolerance Considerations 2.2.1 E nforcement Ana lytical Method/Multire s idue Methods Adequate methods using high performance liquid chromatography with ultraviolet or mass spectrometri c detection (HPLC/UV or /MS) are available for enforcing the current tolerances for methoxyfenozide in primary and rotational crops , and in animal commodities. Depending on the plant commodity , the limits of quantitation ( LOQ s) for methoxyfenozide in primary crop commoditie s are 0.01-0.05 ppm. Data concernin g the recovery of methoxyfenozide using the FDA multiresidue method protocols (PAM V olum e /) were previously submitted to , and reviewed by , HED. Methoxyfenozide was not recoverable by any of these procedures. The data were forwarded to FDA fo r evaluation , and the updating of PAM Volume I.

Page 6of25Methoxyfenozide Summary of Analytical Chemistry and Residue Data DP Barcode D425285 

### 2
. 2 .2 R ecomm ended Toler ances

TABLE2 .2
. 2 To lera n ce S umm a ry for M eth ox f e n oz ide (40 C FR l 180. 544). Pro p os ed o r E x is t i n g* Propo s ed or E xi s tin g* R ecomm e n de d Corr ect Co mmodi ty D efi nition ; C ommo di ty To l era nce (oom) To l e rance ( oom) Commen ts 40 CFR**180 .54** **41 llll**  Fruit , s tone , group 12-12 , 3
. 0 3.0 Conversion from stone fru it group 12 except p lum , prune , fresh except fresh prune plum. Nut , tree , group 14

- 12 0.10 0.10 Convers ion from tree n ut group 14. Herb subgroup l 9A , 400 400 Herb subgroup 19A; based on fie ld trial except chive , fresh , leaves data on dried chives submitted by IR-4. Subgroup I 9A only includes dried chives , not fresh. Onion , green , subgroup 3- 5.0 5.0 Onion , green , subgroup 3

- 0 7 B, except 078 , except chive chive ,fresh leaves; Based on field tria l data on fresh chives submitted by IR-4. Chive , fresh, leaves 30.0 30 Chive,fresh leaves ; based on field tria l data on fresh chives submitted by IR-4. Herb subgroup l 9A. 400* Remove Replace with the tole rance in herb except chive* subgrou p l 9A. Onion , green , subgroup 3- 5.0* Remove Replace with the tolerance in green 078* onion subgroup 3

-078 except c h ive
. Fruit , stone , group 12, 3.0* Remove Conversion to stone frui t group 12 -1 2 except plum , prune , except fresh prune p lum. fresh* Nut, tree , group 14* 0 .1 0* Remove Conversion to tree nut group 14

- 12
. 40 CFR**180. 44** **dll2 1**  Chive * 4.5* Remove Covered by new chive tolerance in § 180.544[a][ I]. * A tolerance is currently establ ished at the listed level in the corresponding commodity. 

### The currently established tolerance expression for methoxyfenoz ide i s ad equate, and in cludes both coverage a nd compliance statements for enforcement purposes. The use patterns, application rates , and represe ntative commodities are t he same for tree nut group 14 and tree nut group 14

- 12. Therefore, HED recomme nds in favor of a ll ow ing the conversion. The use patterns, appl ication rates , and representative commodities are the same for stone fruit group 12 except fres h prun e plum and stone fru it group 1 2-12 except fresh prune plum. Therefore , HED recommends in favor of a ll owing the convers ion . 

### 2
. 2
. 3 R ev is ion s to P etitioned-For T o leranc es HED recommends in favor ofIR- 4's proposal to re move the chive exception to the exis ti ng herb subgroup 19A except chive tolerance , but against IR

-4 's proposal to replace it with an exception Page 7of25Methoxyfenozide Summ ary of Analytical C he mi stry and Re s idue Data DP B arcode D425285 

### fo r fresh chive leaves , whi ch are not included in s ub group 19 A (fres h chives are included in green onion subgroup 3

- 07 B ). The chive field trial data s upp ort a tolerance o f 30 ppm in/on fres h chives , and 300 ppm inio n dried chives, based on input of th e resid ue data into the Organi zatio n fo r Economic Dev elopme nt and Cooperati o n (OEC D ) t o lerance calculation procedure. However , dried chives will b e covered under herb subgroup 19 A, which has an existing to leran c e estab li s hed at 400 ppm. In s t ead of th e proposed tolerance in chive fresh leaves (30
. 0 ppm), HED reco mmends estab li s hin g th e tol erance at 30 ppm. The Age nc y es tabli s hes tol erance s us ing whole numbers for tol era nce s of 10 ppm or more , per the OECD's 

### Use r Gu id e ENV /

JM/MON0(2011)2 for the O EC D to le ranc e calculation procedure. 2.2.4 Inte rnational Harmonization 

### Codex has not estab li s hed MRLs for methox yfe n ozid e in e ithe r g reen o nion s or herbs
. Canada's PMRA has an exis tin g MRL 

### in various g reen onions/ l eeks at 5 m g/kg , which is harmonized with the ex isting tolerance of 5.0 ppm in green onion subgroup 3-07 8. PMRA has an ex i stin g MRL in various fresh herbs at 80 mg/kg, whic h is not harmonized with the recommended tolerance of 400 ppm in herb subgroup 19A, nor th e r ecommended tolerance of 30 ppm in chive. HED cann ot recommend for harmonization of the subgroup l 9A tolerance with PMRA's MRL, because 400 ppm was the resu lt of the O rganizat io n for Econom ic Cooperation and Deve lopm en t (OEC D ) to le rance calc ul atio n procedure for methoxyfenozide residues in basil, and reduction of the tolerance would result in th e risk of vi olati ve residues resulting fro m prop er use according to label directions. HED al so cannot recommend fo r harmo ni zatio n of the chi ve tolerance with PMRA's MRL, because increasing the recommended tolerance to 80 ppm in chive would result in th e ri sk of undetected mi s us e (via seasonal app li cation rates exceeding the label directions). Codex ha s an ex isting MRL in sto n e fruit at 2 mg/kg, which is not harmoni ze d with the recomme nded toleran ce of 3
. 0 ppm in stone fruit group 12- 12 except fres h prune plum. HE D cannot recom m end for harmonization of th e group 12- 12 tol e ranc e with Codex's MRL, becaus e 3.0 ppm was the res ult of the OECD tolerance calculation procedure for methoxyfenozide r es idu es in s ton e fruit, and reduction of the toleranc e would resu lt in the ri sk of violative residues r esu ltin g from proper use acco rding to label directions. PMRA has ex is tin g MRLs in variou s plum s / ap ri co ts/ j ujub es/ sloes at 0.7 mg/ kg, and in var iou s c herri es/peaches/ nectar ines at 6 mg/kg, ne ither of whi ch is harmonized w ith the recommended tolerance of 3.0 ppm in stone fruit group 12-12 except fresh prune plum. HED cannot recommend for harmonization of the group 12

- 12 to le rance w ith PMRA ' s MRLs , because EPA ' s tolerance is estab li s h ed in the entire crop group, not in separate subgroup s. Codex has an ex isting MRL in tree nuts at 0.1 mg/kg , w hi ch is harmonized with the recommended to lerance of0.10 ppm in tree nut group 14-1 2. PMRA has an ex isting MRL in a large variety of tree nuts at 0.1 mg/kg, which is ha rmoni zed w ith the recommended tolerance of 0.10 ppm in tree nut gro up 14-12. Page 8 of25Methoxyfenozide Summary of Analytical Chemistry and Residue Data DP Barcode D425285


### 2.3 Label Recommendations None. 

### 2.4 Submittal of Analytical Reference Standards (860.1650) The analytical reference standard for parent methoxyfenozide, with an expiration date of 28 July 2018 , is currently available in EPA' s National Pesticide Standards Repository (NPSR), per Email communication from Theresa Cole of the Biological and Economic Analysis Division's (BEAD ' s) Analytical Chemistry Branch (ACB) on 19 February 2015. The registrant is required to maintain reasonable amounts of the reference standards for methoxyfenozide and its metabolites in the NPSR as long as tolerances remain pub li shed in 40CFR § 

### 180.544. When necessary, new reference standards , or updated certificates of analysis (CO As), should be sent to the ACB , which is located at Fort Meade, MD
. It 

### should be sent to the attention of either Theresa Cole or Thuy Nguyen at the address listed below, along with a letter of transmittal. 

### Please note that the full 9-digit ZIP Code is required, or the mail will 

### be returned to the registrant. USEPA National Pesticide Standards Repository Analytical Chemistry Branch/BEAD/OPP 701 Mapes Road Fort George G
. Meade, MD 20755-5350 The letter of transmittal should include the assay of the standard, name of the analytical method used , a statement of principal impurities, purification procedures employed, storage requirements, and special precautions for safe handling. Replacement of standards, or updated COAs , may be required periodically if supplies are exhausted , if the standards expire, or if decomposition occurs during storage . Material Safety Data Sheets (MSDSs) must accompany all analytical standards as specified by the Occupational Safety and Health Administration (OSHA) in 29CFR §1910.1200. In addition to the parent compound, the metabolites included in the various tolerance expressions are currently available in the NPSR, as listed below with their respective expiration dates. Methoxyfenozide metabolite RH-117 ,236: Methoxyfenozide metabolite RH-141,518: Methoxyfe no zide metabolite RH-151,055: Methoxyfenozide metabolite RH-152 ,072 : 13 August 2021
. 27 July 2021. 2 Jul y 2018. 15 July 20 1 8.

Page 9of25Me th oxyfe no zide S ummary of Analytical Che mi stry and R esidue Data DP Barcode D4 25285 

### 3.0 C hemical Identi ty Methoxyfenoz ide is a diac y lhydrazine insecticide used on a variety of crops for control of armyworms and othe r lepidopterous pest species. 

### It mimi cs the actio n of the molting hormon e of lepidoptero u s larvae , caus in g the larvae to undergo an incomplete and premature molt, which ultimate ly res ult s in their death
. The chemical s tructure and nom e nclature of methoxyfenozide are li ste d in Tabl e 3.1, and its physicochemical properti es are pre se nted in Tab le 3.2 (belo w). 

### 3.1 Nomenclature

TABLE 3. 1 M eth oxyfenozide Nomenclature
. C he mical s tructure H 3 C f'l 3

r CH 3 C ll

# q--<-~**'** 0 0

## ~**~** 1-1 3

C -O CH 3 CH 3 Common name Methoxyfenozide Company experim ental n ame RH- 2485 Molecular formu la C22 H2 sN 2 0 3 Molecular weight 368.47 I UPAC name N-tert -butyl-N '-(3-methoxy-o-toI uo y l)- 3 ,5

-xy lo hydrazide CAS n am e 3 -me thoxy

-2 -m ethylbenzoic ac id 2-(3 , 5-d im eth y lbenzo y l ) -2- ( I, Idimethylethyl ) hydraz id e C A S registry number 161050-58-4 End-use product (E P) 2 lb ai/ gal (240 g ai/L) flowabl e concentrate (F I C) form ul ation ( Intrepid 2F; EPA Registration # 62719-442)
. 

### 3.2 Phys ico c hemical C h a r acte ri s tic s

TABLE 3. 2 Ph ys i coc h e m ica l Pro lerti es of M eth oxyfe n oz ide. Param et e r V a lu e Reference Me ltin g point/range ( °C) 206.1

-208 D 23 I 303 , H
. Podall , 19 pH 7.0 May 1997 Den s ity { g/ cm 3 ) 0. 740 ± 0.0081 Water solubilit y (mg/Lat 20 ° C) .., .., .),.) Solvent solubi lity { g/L at 20° C) N

- heptane 1.87 Xylene 3.38 1 , 2

- dichloroethane 36.72 Methanol 1 92.92 2-Propanol 50.22 V apo r pressure (Pa at 25 °C) 1.33 x JQ-5 Di ssoc i ati o n co n s tant , pK. None Page 10 of25Methoxyfenozide Summary of Analytical Chemistry and Residue Data DP Barcode D425285 TABLE3.2 Phvsicochemical P r o Je rti es of Meth oxvfenoz ide. Parameter Va lu e Reference Octanol/water partition coefficient 3.72 ± 0.04 (Log [Kow ]) UV/ visible absorption spectrum No absorption expected at A> 300 nm Methoxyfenozide is a solid under ambient conditions, and has a somewhat low volatility. The compound has a relatively low solubi li ty in water, and moderate solubility in organic solvents. Its octanol/water partition coefficient suggests that accumulation of methoxyfenozide in fatty tissues is possible. 

### 3
. 3 Pesticide Use Pattern/Directions for Use (860 .1200 ) Dow AgroSciences has requested that a new Section 3 use of the insecticide methoxyfenozide on chives be added to the label for Intrep id 2F (Registrati on #62719-442)
. Intrepid 2F is an FIC formulation conta inin g 22.6% ai by weight , which is equivalent to 2 lb ai/gal. An example of the proposed label for Intrep id 2F was provided, and the proposed use directions therein are summarized in Table 3.3, below.

TABLE3.3 Summarv of Proposed Use Dir ectio n s for Meth oxvfe no zide on Ch ives. Application T y pe ; Single Use Max
. Max. pHJ2 Use Directions, Application Equ ipm ent 1 Rate (lb Uses Per Seasona l Use (Days) Timing, and Limitations ai/A) Seaso n R ate (lb ai/A) Foliar ; ground or aerial 0.06-0.25 NS 3 1.0 I Minimum RTI 4 of I 0 days. May equipment. not be applied v ia chemigation
.



### . . I. For ground appllcat1on , apply ma mm1mum of 10 gallons of water per acre (GPA) to young/small plants , or in a minimum of20 GPA to densely foliated or difficult to cover crops. For aerial application , apply in a minimum of 10 GPA. 2
. PHI = Pre-Harvest Interval. 3. NS = Not Specified. 4. RTI = Re-Treatment Interval. 

### Conclusions: The use directions for application to chives are sufficient to allow for evaluation of the submitted residue data relative to the proposed use pattern.


### 4.0 Metabolite/Degradate R es idu e Profile 4.1 Natu re of the Residue 0258034 ; W. Wassell ; 23 Jul y 1999 0251225; W
. Wa sse ll ; 27 Jul y 1999 0259989; W. Wa sse ll ; 8 August 2000 The nature of methoxyfenozide residues in primary crops i s adequately understood , based on acceptable metabolism studies in cotton, apples, grapes and rice. Methoxyfenozide does not Page 11 of25Methoxyfenozide Summary of Analytical Chemistry a nd Residue Data DP Barcode 0425285 undergo exten sive metabolism in primary crops. HED has determined that the residue of co ncern ( RO C), for both the tolerance expression and risk assess me nt in primary crops ( and dri nking water), i s parent m eth oxyfenozide o nl y. 026 9986; M.J. Nelson ; 7 August 2002 The nature of m ethox yfe nozide residues in rotation al crops is adequately understood , based on acceptable metaboli s m s tudies in confined , limited field , and exten s iv e field rotational crop s tudie s. Fo r e nforc ement purposes, the ROC fo r high-moi s ture rotational crops is the parent compound ; the metabolites RH-151 , 055, RH-152 ,072 , RH-117 ,23 6, RH-152 , 067 , RH-1 3 1 , 157 and RH-152 , 07 1 are a lso to be taken into account for ri sk assessment. For enforcement purpo ses, th e RO Cs fo r low-moist ure rotational crops are the combined re s idues of parent and me tabolite s RH-151 , 055 , RH-152 , 072 and RH-117 ,236; metab o lites RH-15 2,0 67 , RH-131 , 157 and RH-15 2,07 1 are also to be taken into account for ri sk assess ment. MAR C Memo; 0258034 W. Wassell ; 23 J u ly 199 9 T he nature of the residue in ruminants and p oultry is adequate ly understood , based on the ava il ab le metabolism studies in lactating goats , and lay ing hen s, respectively. HED has determined that the ROC in milk and ruminant tissues (o ther than li ver and kidney) is parent compound; in ruminant li ver and kidney it i s m eth oxyfenozide and its RH-141 , 518 metabolite. The re s idue of co nc ern in poultry meat (mu scle) a nd fat i s parent me th oxyfenozide
. The re s idu e of co ncern in eggs, poultry liver , and p o ultry meat byprodu cts i s meth oxyfenozi de and its metabo lite RH-141 ,5 18. 4.1.1 S ummary of Plant and/or Livestock Metabolism (860.1300) Data h ave been s ubmitted a nd reviewed depicting the me tab o li s m of me thoxyfenozide in numerou s crops and the env ironment. HED has determin e d th e p lant and livestock ROCs for purp oses of toleranc e enforcement and risk assessme nt ; see Table 4.1.1 , below.

Page 12of 25Methoxyfenozide Summary of Analytical Chemistry and Residue Data DP Barcode D425285
TABLE 4
. 1.1 Summary of Metho xy fenoz id e Metabo lites and Degradates to be inc luded in the Risk Assessment and Tolerance Exp r ess ion . Mat ri x Residues Included i n Risk Residues Included in To lerance Assess ment Expression Plants Primary Crops Parent methoxyfenozide Parent methoxyfenozide Rotational Crops Parent met hoxyfenoz id e and Parent methoxyfenozide (High Moisture) metabolite s, RH-151 , 055 , RH-152 , 072 , and RH

- 117 ,236, RH-152,067 , RH131, 157 a nd RH -152,07 1 Rotatio na l Crops Parent methoxyfenozide and Parent methoxyfenozide and (Low Moisture) metabol ites , RH-151,055 , RH-152 , 072 , metabolites RH-151,055 , RHand RH-117,236 , RH-152 , 067 , RH- 152 , 072 , a nd RH-117 , 236 13 1, 157 and RH-152 , 071 TABLE 4.1.1 Summa ry ofMethoxyfenozide Metabo li tes and Degradates to be inc luded in the R i sk Assessment and To l erance Express i on. Matrix Res idues Incl u ded in R isk Residues Included in To l erance Assessment Exp r ession Livestock Ruminant M ilk , Parent methoxyfenozide Parent methoxyfenozide Meat and Fat Ruminant Liver Parent me thoxyfenozide and metabolite Parent me th oxyfenoz id e and and Other Meat RH- 141 , 518 metabolite RH-141,518 Byproducts Pou ltry Meat and Parent rnethoxyfenozide Parent methoxyfenozide Fat Poultry Eggs , Liver Parent rnethoxyfenozide and Parent methoxyfenozide and and Other Meat metabolite RH-141 , 518 metabolite RH-141 , 518 Byproducts Drinking Water Parent methoxyfenozide Not appl icable 

### Conclusions: The nature of the residue in plants and animal s has been adequate ly delineated. 

### 4.1.2 Summary of Confined Rotationa l Crops (860 .1 850) 0258034 W
. Wa sse ll ; 23 Ju l y 1999 0251225 ; W. Wa sse ll ; 27 Ju ly 1999 0269986 ; M. J. Ne lson; 7 August 2002 

### The nature of methoxyfenozide residues in rotational crops is adequate ly understood , based on the available confined rotational crop study. Following three soi l applications of 1 4

### C

- methoxyfenozide at rates totaling 2.0 lb ai/A ( I X rate) , total rad io active residues accumulated at**0.01** 

### ppm in mustard , radishes and wheat planted 3 1 , 91 and 364 days after the last application. Methoxyfenozide was highly metabolized in rotational crops by oxid atio n , demethylation , and hydroxylation to non-conjugated metabolites , which were then conj u gated w ith biomo lecu les , y ie lding bound residues and precursors in the sugar synthes i s pathway. 

### 4.1.3 Summary of Rat Metabolism Ri s k A ssess m e nt Doc u ment 0388978 ; M. Co ll a n t cs; 23 Ma y 2012 (PP#lE7842)
Page 13 

### of25Methoxyfenozide Summary of Analytica l Chem istry and Residue D ata DP Barcode D425285 

### In the rat, 14 C-radiolabeled methoxyfenozide was rapidly absorbed following gavage administrati on, with maximum peak p lasma concentrations observed within 15 minutes of dosing. Peak plasma concentrati ons at 10 mg/kg ranged from 0.70-1.09 ppm in males, and 0
. 50- 0.59 ppm in fema les, depending on the ring location of the radio labe l. At 1000 mg/kg , peak levels were 26.11-35.52 ppm in males, and 21
. 92-29
.74 ppm in females. Plasma elimination was biphasic , with an a-phase T1 1 2of0
. 2-0.6 hours , and a P-phase T1 12 of15.2

- 35
. 6 hours , and showed some variation with radiolabel location
. The total plasma elimination rate was longer for th e high dose compared to the low dose animal s, suggesting metabolic pathway saturation, and the effect was more prominent in female rats. Radioactivity was extensively distributed among tissu es, with the highest concentrations at Cmax (0.25 hr) 

### observed in the intestinal tract , stomach , liver and residual carcass. Enterohepatic circulation was observed. Methoxyfenozide did not show a potential for bioaccumulation. By 5 days post-treatment, the highest levels were observed in the liver and carcass, but tissue radioactivity in all tissues was insignificant by that time. Excretion of radiolabel was essentially complete by 48 hours postdosing
. Based on the minimal level of radioactivity in tissues at 72 hours , absorpti on was estimated to be at least 62-70% of the administered dose (b ili ary plus urinary excretion). The major route of excretion was in the feces (86-97% of the administered dose), with 5-13% of the dose excreted in the urine
. Sign ificant dose- or sex -dependent differences in metabolic disposition were not observed. Methoxyfenozide was extensively metabolized. The major routes of metabolism involved o-demethylation and oxidative hydroxylation of the A -ring phenyl and/ or B-ring methyl groups, fo ll owed by glucuronic acid o r sulfate conjugation. In addition to the parent compound , seven major metabolites were identified in excreta. These included RH-131 , 157 , RH-141 ,58 1 and RH-117,236 , metabolites also identified in residues in crops and/ or livestock. Up to 25 metabolites were isolated from urine , but the majority represented < 1-2 % of the radioactive dose. Up to 16 metabolites were identified in the feces, including the pare nt compound, with only six containing 2: 5% of the administered radiolabel. The major fecal metabolites in all groups were products of Phase I 0-demethylation and oxidative hydroxylation on the A-ring and , to a lesser extent, the B-ring. Levels of excreted parent compound in the feces were greater in animals receiving 1000 mg/kg test material (30- 39% of dose) when compared to the 10 mg/kg groups (14

-26% of dose) , consistent with saturation of absorption. In 

### the bile, up to 24 metabo li tes were detected , with the primary metabolite (13-18% of dose) bein g derived by g lu curonide conjugation at the o - demethylated alpha ring. 4.1.4 Summary of Environmental Degradation EFE D M e mo ; 0388876; K. Milians; 17 August 2011 

### Methoxyfenozide is very persistent (T 1 12 = 1 to 3 years in so il and water) , and moderately mobile (Koc = 219-922 L/kgoc in various soils). It is stab le to photolysis and hydrolysis , is not significantly vo l atile , and degrades only very slowly by microbial activity. Degradates are predominantly RH-117 ,236 and RH-131 , 154 , but these are onl y present at low concentrations. Page 14 

### of25Methoxyfenozide Summary of Analytical Chemistry and Residue Data DP Barcode D425285 

### Because of its resistance to degradation and it s mobility, methoxyfenozide has the potential to accumulate and to move off the site of app li cation by leaching and erosion/runoff, resulting in ground

- and surface-water contam in ation.


### 5.0 Residue Profile 5.1 Residue Analytical Methods (860.1340) 5.1.1 Data Collection Methods MRID #49420201 

### The data collection method used for chive sample analysis was derived from Dow AgroSciences method ORM: 02.25, 

### Determination of Residues of Methoxyfenozide in High Moisture Crops by Liquid Chromatography with Tandem Mass Spectromefly Detectfon, S.L. Byrne and M.J. Hastings , 4 October 2002; and Rohm and Haas Report Number 34

- 98 -87 , titled 

### Tolerance Enforcement Method for Parent RH-2485 in Pome Fruit. Residues of methoxyfenozide were extracted from fresh and dried chives by homogenization with 90% methanol/ I 0% 0.1 N HCl, which was then shaken and centrifu ged. The extract was purified by solid phase extraction (SPE) using an Evolute ABN SPE cartridge. The extracts were then analyzed by liquid chromatography with tandem mass spectrometric detection (LC/MS/MS). Based on recoveries from samples fortified at the lowest level of method validation (LLMV) , the limit of detection (LOD) and LOQ in fresh leaves were 0.0016 ppm and 0.0048 ppm, and in dried leaves were 0.0146 and 0.0438 ppm , respectively. Analytical sets typically consisted of calibration standards , unfortified controls , fortified controls, and treated samples
. A calibration standard was injected at the beginning and end of each analytical set. Control samples were fortified and analyzed both prior to, and concurrently with, the field trial samples. Method validation recoveries of methoxyfenozide from samples of fresh chives fortified at 0.010 ppm to I 0.0 ppm ranged from 83 to 91 % (86 ± 

### 3%; n = 

### 9). Concurrent recoveries from samples of fresh chives fortified with methoxyfenozide at 0.010 ppm to 20 .0 ppm ranged from 84 to 98% (92 ± 

### 6% ; n 

## =7). Method validation recoveries of methoxyfenozide from samples of dried ch ives fortified at 0 .0 50 ppm to 50
.0 ppm ranged from 85 to 89% (87 ± 

### 2%; n 

## =9). Concurrent recoveries from dried chives fortified at 0.050 ppm to 200 ppm ranged from 81 to 106% (92 ± 11 % , n 

## =7). Recoveries were within the generally recognized acceptable range of 70-120%
. The fortification levels used in concurrent method recovery were adequate to bracket expected residue levels. Method validation and concurrent recovery results are summarized in Table 5.1.1 below. Methoxyfenozide residues in control samp les of fresh and dried ch ives were <0.010 ppm and < 0.050 ppm, respectively. A five-point standard curve was generated by inj ecti n g constant
Page 15of25Methoxyfenozide Summary of Analytical Chemistry and Residue Data DP Barcode D42528 5 volumes o f standard sol utions each time an analytical set was run . The correlation coefficient was always reported to be 2:: 0.999.

T A B LE 5. 1.l S umm ary o f Me t h oxy f e n oz ide R ecover ies fr o m C h ive L eaves. Matr ix Sp ik e leve l Sa mp l e size T y p e o f Recove ri es Mean ± Std. (p pm) ( n ) R ecover y (%)**eviat (%)~**  Chives (Fresh 0.010 6 MVR 1 91, 88, 88 89 ± 2 Leaves) CR 2 97,97,98 97 ± I 0.300 3 MYR 85, 84 , 84 84 ± I 2.00 3 SSC R 3 89,93 , 92 91±2 10 .0 4 MYR 84,83, 84 84 ± I CR 91 91 20.0 3 CR 88,84 , 86 86 ± 2 C hives ( Dried 0.050 6 MYR 87,88, 89 88 ± 1 Leaves) CR 106 , 102, 103 104 ± 2 2.00 6 MVR 86,85 , 85 85 ± 1 SSCR 90 , 88 , 88 89 ± 1 50.0 4 MYR 86 , 85 , 88 86 ± 2 CR 92 92 200 ... .) CR 82 , 81 , 81 81 ± 1 I. MVR = Method Validation Recovery. 2
. CR = Concurrent Recovery. 3. SSCR = Storage S tability Concurrent Recovery. 4. Standard deviation is not calculated for sample sets with n < 3. Conclusions: Adequate method validation data have been sub mitted for the LC/MS/MS method used for the determination of methoxyfenozide residues in fresh and dried chive leaves. No additional data are required in support of this data co ll ec t ion method. 

### 5
. 1.2 Multi

-R es id u e M ethod s (860
. 13 6 0) 0 25 1 225; W
. Wa sse ll ; 27 Ju ly 19 99 Data concerning the recovery of methoxyfenozide using the FDA multi residue method protocols (PAM Volume!) were previously submitted to , and reviewed by , HED. Methoxyfenozide was not re cove rabl e by any of these procedures. The data were previously forwarded to FDA for evaluation , and for the updating of

### PAM Volume 

### 1. It was also noted that the European Food Safety Authority (EFSA} has concluded that the multiresidue QuEChERS method , combined with LC/MS /MS , i s adequate for tolerance enfo rc e ment in p lan t and animal commodities (EFSA , 

### 2014). 5
. 1 .3 

### To le r a n ce E n fo r ceme nt Meth o d s 035834 1 ; D
. R ate; IO J u n e 2009 Several HPL C/UV and HPLC/MS methods are available for enforcing tolerances of met hoxyfen ozide in primary crops, Method TR 34-96-88 , Method TR 34 -98-87 , Method TR 34- 

### Page 16of 25Methoxyfenozide Summary of Analytical Chemistry and Residue Data DP Barcode 0425285 

### 00-38 , Method TR 34-00 -1 07 , Method TR 34

- 00 -1 09 , and Method TR 34-99 -74
. Adequate method validation , radio-validation , and independent laboratory validation (IL V) data have been provided for these methods. Successful petition method validation (PMV) trials were conducted on Methods TR 34-96-88 and TR 34-98-87, and BEAD ' s ACB concluded that PMV trials were not required for the other methods , since they are similar to the validated methods. For each of these methods , residues of methoxyfenozide are extracted with acidic aqueous methanol , filtered , and diluted with 1 0% sodiwn chloride. Extracts are then purified by sequential liquid- liqui d part itioning with hexane and dichloromethane (DCM). Residues in the DCM fraction are further purified by elution through one or more of the fo ll ow in g colwnn types : basic alumina, silica gel , carbon , Flor is il , or C1s
. Residues in the final eluate are concentrated , re-dissolved in ACN/ water, and ana lyzed by reverse-phase HPLC using UV (240 nm) or MS (m/z 367) with external standards. The LOQ for methoxyfenozide is 0
.01-0.05 ppm , depending on the plant commodity
. An adequate enforcement method is also available for determining the ROCs in rotated crops. Method TR 34

- 00

-41 includes an HPLC/UV method that determines methoxyfenozide residues in high

- moisture rotational crops , and an HPLC/MS method that determines residues of methoxyfenozide and its metabolites RH-117 ,236 , RH-151 , 055 and RH

- 152 , 072 (determined as RH

- 151 , 055) 

### in low -moisture rotational crops. Adequate method validation , radio-validation , and ILV data have been submitted for this method , and ACB concluded that a PMV trial was not needed for this method owing to its s imil arity to Method TR 34-98 -87
. 

### 5.2 Storage Stability (860.1380) MRID #49420201 

### Chive samples were stored frozen for up to 119 days (fresh leaves) and 122 days (dried leaves) after collection. A freezer storage stability study was conducted using samp les of chives fortified with 2.00 ppm methoxyfenozide , and stored for 110 days (fresh leaves) and 112 days (dried leaves). Concurrent recoveries of methoxyfenozide during ana lysis of storage stab ility samples of fresh leaves and dried leaves ranged from 89 to 93% (91 ± 

### 2%; n 

### = 3) and 88 to 90% ( 89 ± 1 % ; n 

## = 3) , respectively. Recoveries from stored chives fortified with methoxyfenozide at 2.00 ppm ranged from 91 to 93% (92 ± 1 %; n 

## = 3) and 86 to 87% (86 ± 1%;n=3) for fresh and dri ed chives , respectively (see Table 5
. 2
. 1 , below)
.

TABLE 5.2.1 Summary of Storage Co nditions. Matrix Storage Actua l Sto r age interval of Demonstrated Storage Stability Temperature (°C) Duration <Days)* Storae:e Stability (Days) Recoveries (%) Chive s < -2 0 119 110 91 , 91 , 93 ( Fresh Leaves ) Chives <-20 122 112 86 , 86 , 87 ( Dried Leaves) 

### * Inte rval from harve s t to analysis ; samples were analyzed within 1-4 days of extraction.
Page 17 of25Methoxyfenoz ide Summary of Analytical Chemistry and Residue Data DP Barcode D425285 

### Conclusions: There are no storage stability issues , and no corrections for potential decline during storage are needed in reviewing the residue data submitted for chives. 

### 5.3 Residue Data 5.3.1 Crop Field Trials (860.1500) MRJD #49 420201 

### IR-4 has submitted field trial data fo r methoxyfenozide on chives. Three field trials were conducted in the US, encompassing NAFTA Zones 2 (MD; 1 trial) and 10 (CA; 2 trials) during the 2012 growing season. At each field trial site, chives were treated with four foliar applications of methoxyfenozide , as Intrepid 2F (EPA Registration# 62719-442), an FIC formu lati on containing 22.6% ai by weight , equivalent to 2 lb ai/gal. Foliar broadcast applications were utilized , except at one of the CA trial s ites, where treatments were fo li ar directed applications
. All foliar applications were made at a targeted rate of 0.25 lb ai/A per application, for a total seasonal use rate of approximate ly 1.0 1 b ai /A. Applications were made at RTls of 8

- 11 days , with a PHI of 1 day. In the two California field trials, untreated samp les were harv ested on the day ofthe l ast application. An 

### N I S adjuvant was included in each tank mix at all trial sites. The chive field trial residu e results are summarized in Table 5
. 3.1, below. Following four foliar broadcast/directed applications of the 2 lb ai/ ga l FlC formulation of methoxyfenozide at approximate ly 1.0 lb ai/A, residues of methoxyfenozide in fresh and dried chive leaves harvested at a 1 -day PHI , were 5.7-13 ppm and 12- 118 ppm, respectively.

TABLE 5.3 .1 Summary of Residue Data from Chive Field Tria ls with Methoxvfenoz ide. Commodity Total Use PHI Residue Levels (ppm ' 1 Rate {lb ai/A) (Days) n Min
. Max. HAFT 2 Median Mean Ch ives (Fresh Leaves) 0.994-1.00 1 6 5.7 1 3 12.5 7.1 8.6 Ch ives (Dried Leaves) I 6 12 118 115 64 64 I. Except for sample minimum and maximum , values reflect per trial averages ; n = number of field trials. 2. HAFT = Highest Average Field Trial. Std. Dev
. 3.1 46



### Conclusions: The submitted crop field trial data are adequate, and support the removal of the exception for chives in the ex i sting herb subgroup 19A tolerance, addition of an exception for chive fresh leaves to the existing green onion subgroup 3-07B tolerance , and establishment of a stand-alone tolerance 

### in chive fresh leaves at 30 ppm. 

### 5.3.2 Field Rotational Crops (860.1900) Label directions for methoxyfenozide (Intrepid 2F) currently specify that crops with registered uses may be replanted at any time , and all other food or feed crops may be replanted 7 days after Page 18 of25Methoxyfenozid e Summary of Analytical Ch em istry and Re s idue Data DP Barcode 0425285 the last application. Adequate limited and extensive rotational crop field trials are available that support these rotational crop restrictions. There are no rotational crop issues associated with the proposed us e on chives. 

### 5.3.3 Processed Fo od and Feed (860
. 1520) MRID #49420201 The processed commodity for fresh chives is dried chives , although these are considered a RAC under herbs and spices group 19. Samples of dried chives were produced at the field trial sites , and subsequently analyzed along with the fresh chive samples
. 

### 5.3.4 Meat, Milk, Poultry and Eggs (860.1480) No significant live stock feedstuffs are associated with the proposed new use on chives. 

### Conclusion: Reassessment of the currently established livestock tolerances is not required for this petition. 

### 5.3
. 5 Food Handling (860.1460) There are no proposed uses that are relevant to this guideline topic. 

### 5.3.6 Water, Fish and Irrigated Crops (860.1400) There are no proposed u ses that are relevant to this guideline topic 

### 5.4 Food Res idue Profile The data submitted in support of the current action (PP# 4E8298) along with previously revi ewed data, are adequate for purposes of risk assessment and tolerance assessment for the proposed use under review. Maximum residues of methoxyfenozide are expected to occur at moderate to high levels (up to 30 ppm in fresh ch i ve l eaves , and up to 300 ppm in dried chive leaves) from the n ew us e on chives proposed in the current petition. Methoxyfenozide residues generally tend to decline or remain stable with increasing 

### PHI , and do not increase to any significant degree
. Following fo li ar app li cations , methoxyfenozide is present primarily as surface residues ; translocation does not appear to be extensive. 

### In general , methoxyfenozide residues do not tend to concentrate in processed fractions, other than via dehydration or from surface residues. Residues of methoxyfenozide are not expected to accwnulate above the LOQ in rotational crops planted at PBIs of 7 days following application of methoxyfenozide to primary crops. Page 19 of25Methoxyfenozide Summary of Analytical Chemistry and Residue Data DP Barcode 0425285



### 6. 0 To leran ce Derivation HED recommends in favor ofIR-4's proposal to remove the chive exception to the existing herb subgroup 19A except chive tolerance, but against IR

- 4's proposal to replace it with an exception for fresh chive leaves , which are not included in subgroup 19A (fresh chives are included in green onion subgroup 3

- 07B). The chive field trial data support a tolerance of 30 ppm in fresh chives, and 300 ppm i n dried chives, based on input of the residue data into the OECD to l erance calculation procedure
. Instead of the proposed tolerance in chive fresh l eaves (30.0 ppm), HED recommends establishing the tolerance at 30 ppm. The Agency estab l ishes tolerances using whole numbers for to lerances of I 0 ppm or more, per the OECD's 

### User Guide ENV /

JMIMON0(2011)2 for the OECD tolerance calculation procedure. Upon establishment of the recommended tolerance in herb subgroup 19A, the existing tolerance in herb subgroup 19A except chive should be removed (40CFR §180.544[a][l]). Upon establishment of the recommended tolerance in chive fresh leaves at 30 ppm (40CFR §180.544[a](l]), the existing to l erance for indirect or inadvertent methoxyfenoz ide res idues in rotational crop chives at 4.5 ppm should be removed (40CFR § 180.544[ d](2]). Upon establishment of the recommended tolerance in green onion subgroup 3-07B except chive fresh leaves, the existing tolerance in green onion subgroup 3-07B should be removed (40CFR §180.544[a](1]). Upon establishment of the proposed to lerance in tree nut group 14-12, the existing tolerances in tree nut group 14 and pistachio should be removed (40CFR §180
. 544(a][l]). Upon establishment of the proposed tolerance in stone fruit group 12-12 except fresh prune plum, the existing tolerance in stone fruit group 12 except fresh prune plum should be removed (40CFR § 180.544( a ] [I])
. An International Residue Limit Status sheet is appended as Attachment I
. Data sets and results from the OECD tolerance calculation procedure for fresh and dried chive leaves are appended as Attachment 2
.

Page 20 of25Methoxyfenozide Summary of Analytical Chemistry and Residue Data DP Barcode D425285 

### References 

### PP# 8F5004 & 

### PP# 8F5006; Methoxyfenozide. Conclusions of the 71 13199 Meeting of the Metabolism Assessment Review Committee.; 0258034; W. Wassell; 23 July 1999
. PP # 8F5004 & 

### PP # 8F5006: Methoxyfenozide on Cotton and the Pome Fruit Crop Group. Evaluation of Metabolism Data, Residue Data , and Analytical Methodology.; D2494 3 8, 0249458 , D251218 , 0 25 1225 ; W. Wassell; 27 July 1999. PP9F06033: Section 3 Request for Use of Methoxyfenozide on Grapes and Fruiting Vegetables. Review of Analytical Methods and Residue Chemistry Data.; D259989 ; W. Wassell; 8 August 2000. PP#OF06201: Methoxyfenozide inion Various Rotational Crops. R esidue Chemist1y Review
. ; 0269986; M.J. Nelson; 7 Aug ust 2002. Methoxyfenozide. Human Health Risk Assessment to Support Proposed Uses on Root Vege tables and Citrus.; 0388978; M
. Collantes; 23 May 2012
. Drinking Water Assessment for the IR-4 New Use Petitions for the Use of Methoxyfenozide on Root Vegetables for Crop Subgroup 1 B (Except Sugar Beets) and Citrus Crop Group 10.; 0388876 ; K. 

### Milians; 17 A ugust 2011 Methoxyfenozide. Petition for Uses and Tolerances on the Citrus Crop (Group 10), Dried Shelled Peas and Beans, except Soybean (Subgroup 6C), Popcorn, and Pomegranate. Summary of Analytical Chemislly and Residue Data.; 0358341 ; 0
. Rate; 10 June 2009
Attac hm ents 

### Attachment 1 : International Residue Limit Status s heet. Attachment 2: OECO Tolerance Assessment Calcu lations.

Page 21 of25Methoxyfenozide S umm ary of Anal yt ic a l C he mistry and Resi du e Data DP B arcode D425285 

### Attachment 1: International Residue Limit Status. Methoxyfenozide (PC Code 121027) Sum m ary of US Tolerances and Internationa l Maximum Residue Limits
. Res idue Definitions US (40CFR**~180.544)** Canada Codex Primary c r ops: Methoxyfenozide A ll food crops, li vestoc k fat, meat and Methoxyfenozide. T he (3 -me thox y -2-methy lb e nzo ic ac id 2

- meat b y products: 3-methoxy-2- residue is fat-soluble , but is (3 , 5-dimethylbenzoyl)-2-( I , I - methylbenzoic acid , 2-(3,5- not classified as fat

- sol ubl e dimethylethyl) hydrazi d e). dim eth ylbenzoyl)

-2

- ( 1 , I- w ith res pect to its dimethylethyl)hydrazide. distribution in milk. L ivestock: The sum of methoxyfe noz ide and its g lucuronide Livestock kidne y a n d liver: 3 -methoxy -2- metabo li te (3

- ((2-( I , 1-dimethyle th yl)

- methylbenzoic acid , 2

- (3 , 5- 2-(3 , 5 -dime th y lb enzoy l ) -hydrazino) dimethylbenzoyl)-2-( I , Icarbonyl)-2-methylphenyl-13-D- dimethylethyl)hydrazide , including th e gluco pyranuronic ac id ,), calculated as metabo lite 3

- ((2

- ( I , l-dime th y leth yl)

-2-(3 , 5- the stoichiometric equ iv a lent of dimethylbenzoyl)-hydrazino) carbonyl)-2- methoxyfenozide. methylphenyl-13-D-g,lucopyranuronic acid. Commod i ty2 Tolera n ce Commod ity MRL Commodity MRL ( p pm)l (mg/kg) (mg/kg) O ni o n , green , subgrou p 5.0 B e ltsvi ll e bunching onions, 5 3 -0 78 elegans hosta , fresh Chinese c hi ve leaves, chive leaves, fresh onions , friti ll aria leaves , green onio ns , kurrats , lady's l eek , leeks , macrostem on ions , shall ot leaves , tree on io n tops , Welsh o nion tops , wild leeks H erb su bgroup I 9A 400 Fresh leaves (angelica, balm , 80 basil, borage , cilantro, clary, costmary, culantro , curry , dilweed , le mon g ra ss , lovage , rosemary, rue, sage , s ummer savory , sweet bay , tansy , tarra go n , thyme , winter savory , winter gree n , woodruff, wo rmwood ); fresh (bu m et, hore ho und , hyssop tops , lav ender, marigold , m a r joram , nasturtium lea ves a nd flowers)

Page 22 of25Methoxyfenozide Summary of Analytical Chemistry and R esidue Data DP Barcode 0425285
Metb oxvfe n ozide (P C Code 12 1 027) S u mmary of US Tolerances and I n te rn ati ona l Max i m u m Res i due L i mits
. Resid u e Defin itions US (40CFR**~180.544)** Ca n ada Codex Fruit, stone , group 12- 3.0 American plums , Apricots , 0.7 Stone fruit 2 12 , e xcept plum , prune , beach plums , Canada plums, fre s h cherry plums, chicksaw plums , damson plums , fresh prune plums , Japanese apricots , Japanese plums , jujubes , klamath plums, plumcots , plums. sloes Black cherries , capulins , 6 nanking cherries , nectarines , peaches , sweet cherries , tart cherries Nut , tree , group 14-12 0.10 African tree nuts , almond nuts , 0.1 Tree nuts 0.1 beechnuts , black walnuts , Brazil nuts, Brazilian pine nuts , bunya nuts, bur oak nuts, butternuts, Cajou nuts , candlenuts, cashew nuts , chestnuts , chinquapin nuts , coconuts , coquito nuts , dika nuts , English walnuts , g inkgo nuts , Guiana chestnuts , hazelnuts (filbert) , heartnuts , hickory nuts , Japan es e hor s echestnuts , macadamia nuts , mongongo nuts , monkey-pot nuts , monkey puzzle nuts , Okari nuts , Pach ira nuts , peach palm nuts , pecan nuts , pequi nuts , Pili nuts , pin e nuts , pistachio nuts , Sapuca ia nuts , tropical a lmond nuts , yellow horn nuts

Com p leted : M. Negussie; 26 February 2015
. I. Mexico adopts U S tolerance s, and/or Codex MRLs , for its export purposes. 2
. Includes only commoditie s of interest for this action. 3
. Tolerance values are tho s e recommended by HED , not those proposed by the petitioner.

Page 23 of25Methoxyfenozide S umm ary of Ana lytica l Che mi stry a nd Res idu e Data 

### Attachment 2: OECD To lerance Assessment Calculations. Fresh Chive Leav es Residues (ppm) 12
. 500 6
. 700 6
. 550 Methoxyfenozide Fresh chive USA 1.0 lb ai/A, 1-day PHI Total number of data (n) Percentage of censored data Number of non - censored data Lowest residue Highest residue Median residue Mean Standard deviation (SD) Correction factor for censoring {CF) Proposed MRL estimate

- Highest residue

- Mean + 4 SD

- CF x 3 Mean Unrounded MRL Rounded MRL

High uncertainty of MRL estimate. [Small dataset]

Page 24 of25 3 0% 3 6.550 12.500 6.700 8.583 3.393 1 .000

12
. 500 22. 1 54 25
. 750 25
. 750
30 DP Barcode D425285Methoxyfenozide Summary of Analytical Chemist ry and Res idue Data


### Dried Ch ive Leaves Residues (ppm) 115.000 64.000 12
. 500
Methoxyfenozide Dried chive USA 1.0 lb ai/A, 1-day PHI Total number of data (n) Percentage of censored data Number of non-censored data Lowest residue Highe st residue Median residue Mean Standard deviation (SD) Correction factor for censoring (CF) Propo se d MRL estimate

- Highest residue

- Mean + 4 SD

- CF x 3 Mean Unrounded MRL Rounded MRL

High uncertainty of MRL estimate
. [Small dataset]

Page 25 of25 3 0% 3 12.500 115.000 64
. 000 63.833 51. 250

1.000

115. 000 268 .8 34 191.500 268 .8 34 300 DP Barcode D425285Methoxyfcnozide / 62719-44 2/ PC Code I2 I027/ Dow AgroSc i ences/ 627 19 DA CO 7.4.1 / 0PPTS 860.1500 / 0ECD !I A 6.3.1 , 6.3.2. 6.3.3 and lll A 8 .3. 1. 8.3.2. 8.3.3 Crop Field Trial/R esidue Decline

- Chives (Leaves)
Primary Eva luator

P

eer Reviewe r

Approve d by



### STUDY REPORTS Serge i I. Usac henko , Ph
. D
.. En v ironme ntal Scientist, Ca lifornia Department of Pe s ti c id e Reg ulation.

The re s a Ratto , Ph.D. , Senior Environmental Scienti st, (Spec ia li st) Ca lifornia Department of Pest i c ide Reg ul ati o n.

William T. Dre w, C hemi st, Ri sk Assess men t Branch TI ( RAB2 ), He alth Effects Di v i s ion ( H ED ) 750 9P , Office of C hemica l Safety and P o lluti o n Prevention ( O CS PP )
. Office of P est ic ide Program s ( OPP ). USE PA Date: D ece mber 23 , 20 1 4

Date: December 23 , 2014

Date: 28 J anuary 2015

MRID #49420201. Kenneth S
. Samoil (2013) 

### Methoxyfenoz id e: Magnitude of th e R es idue on Ch ives. IR-4 PR Number: 07240. Unpublish e d study prepa re d by Interregional Research Proj ec t Number 4 (IR-4 ). 12 9 page s. 

### EXECUT I VE SUMMARY IR- 4 has submitted field trial data for met hoxyfe noz id e o n c hi ves. Three field trial s we r e conducted in th e US e n co mpa ss in g EPA regions 2 (MD; I trial ) and 10 (CA; 2 trials) during the 20 12 growi ng seaso n . At each field trial site
. c hi ves were treated wit h four foliar appl icati ons of methoxyfenozide. as Intrep id 2F (E PA Re g i s tr ati o n # 627 19-442)
. a flo wab l e co ncentrate ( F) formulat io n containing 22.6% active ingredient (ai ) by we ig ht. eq ui va le nt to 2 pounds of ai per gallon (lb ai/ ga l). Fo li ar broadcast applications we re utilized , except at tri a l s ite 07240.12- CA

## * 1 7. whe re trea tme nt s were foliar dire cte d ap plic ati ons. A ll fo liar applications were made at a targeted rate of 0.25 lb ai per acre ( lb ai/ A) pe r application. fo r a total seaso nal us e rate of approx imat e ly 1. 0 lb ai/ A. Applications were mad e a t re-treatme nt interval s (RTis) of 8-11 days. with the last applic ation one day b efo re harves t. Tn th e two Cali fornia field trials ,
DP B arcode 04 252 85/ MRJD #4942020 I Page I of 10

# ·· - 

# • . Methoxyfenozide/627 I 9-442/ PC Code I2 I027/ Dow AgroSciences/627 I9 DACO 7.4. l /OPPTS 860. I 500 / 0ECD ll A 6.3. I, 6.3.2 , 6.3.3 and lllA 8
. 3. I , 8.3.2 , 8.3.3 Crop Field Tria l/Res idu e De cline

- Chives (Leaves)
untreated samples were harves ted on the day of the last application
. A non-ionic surfactant (NIS) adjuvant was included in each tank mix at all trial sites. Sample analysis for residues of methoxyfenozide was conducted by th e IR- 4 Western Region Laboratory at the University of California, Davis, California. The analytica l method was adequate for data coll ect ion , and was derived from 

### De t e rmination of Residues of Methoxyfenoz ide in High Moisture Crops by Liquid Chromatography w ith Tandem Mass Spectrometty De tection , S.L. Byrne and M.J. Hastings , Dow AgroSciences method GRM: 02.25 , dated 4 October 2002; and Rohm and Haas Re port # 34-98-87, titled 

### Toleranc e Enforcement Method for Parent RH-24 85 in Pome Fruit. The reported limit of detection (LOO) and limit of quantification (LOQ) for methoxyfeno z ide on fresh leaves were 0.0016 ppm and 0.0048 ppm , r es pectivel y . The reported LOO and LOQ for methoxyfenozide on dry leaves were 0.0146 ppm and 0.0438 ppm, re spectively. The lowest levels of method validation (LLMVs) for methoxyfenozide on chive s were 0 .010 ppm (fresh leaves) and 0.050 ppm (dried leaves ). The max imum freezer storage duration for field-treated samples in this study was 119 days for fres h leaves , and 122 days for dried leaves . A storage s tability study was conducted in conjunction with this study with fortified samples that were kept frozen for 110 days (fres h leaves) and 112 days (dried leaves). The results from the chives field trials show that the maximum methoxyfenozide residues following a total seasona l application rate of approximately 1.0 lb ailA , and a pre-harvest interval (PHI) of I day , were 13 ppm and 118 ppm in fresh and dried leaves , respectively. A residue decline study was not conducted. 

### STUDY/WAIVER ACCEPTABILITY/DEFICIENCIES/CLARIFICATIONS U nder the cond itions and parameters used in the study , the chives field trial res idu e data are classified as sci e ntifically acceptable
. The acceptab ili ty of this study for reg ulatory purpo ses is addressed in the forthcoming USEPA Residue Chemistry Summary Docum ent (DP Barcode 0425285). 

### COMPLIANCE Signed and dated Good Laboratory Practice (GLP), Quality Assurance , and Data Confidentiality statements were provided. The follow in g deviation s from GLP regulatory requirements were listed: 1. Weather /in-igation a nd soil characteriza tion at the field sites. 2
. Te s t s ite history at the field sites. 3. Cultural practices dating back to harvest of the pre v ious crop, and maintenance fertilizer and pesticide applications during the field trial year. 4. The pH strip s used to measure the acidity of the can·ie r in the MD04 field trial. 5. Re si due sample weighing equipment in the fi eld tria ls. DP Barcode D4 252 85 / MRID # 4942020 I Page 2of 10Methoxyfenozide/62719-442/PC Code 121027/ Dow AgroScicnces / 62719 DACO 7.4.1 / 0PPTS 860.1500 / 0ECD II A 6.3.1. 6.3.2. 6.3.3 and lllA 8.3.1. 8.3.2. 8.3.3 Crop Field T rial/ Residue Decline

- Chives (Leaves)
6
. The data collected by HOBO temperature lo gge r fo r the test s ub stanc e storage i n the two California trials fo r th e peri od April I st through Jun e pt, 20 l 2 was lost prior to being pri nted. The s torage temperatures for the period were esti mated by ob tainin g copies of the temperature data from a similar storage unit located at the same research farm. However, none of the se deviations had a negative impact on the val idity of the study.
A. B AC K G RO UN D I NF O RMA TI ON Methoxyfeno z ide belongs to the diacylhydrazine cla ss of chemical in sec t icides, and has a novel mode of action for control of armywo rm s and other 

### Lepidopterous pest species on a variety of crops . The chemica l mimics the act ion of the molting hormo ne of 

### Lepidopterous ( moths , butterflies) larvae. Upon ingestion, th e larvae undergo an incomplete and premature molt, which ultimatel y re su lts in their death. Methoxyfenozidc is currently regis t e red to Dow Ag roSci e n ces. T he ap plicant ha s submitted fie ld trial data o n chives (leaves). Th e nomenclature and physicochemical propertie s of methoxyfenozide are presented below in Tables A. I and A.2, re s pe ct iv e ly. TABLE A. I T est Compou n d No m e ncl ature. CH 3 

# Q-11°**o~** -- Mcthoxy!Cnozidc 

### c\ 

### 1 c \ 

# j N-N 

### I \ / CH 3 CH 3 H3 C-O C H3 H /C H 3

C \ CH 3 Co mmon name Methoxyfenozide Co mpany experimental name Rll-2485 Molecular formula CnH2sN203 Molecular weie.ht 368.47 IU

PAC name N

- tert
- butyl-.V "

- (3-mcthoxy- o-tolu oyl)

-3 .5-xylohydrazidc CAS name 3 -rn cthoxv

-2

- methvlben?.Oic acid 2-(3.5

-dimethvlbenzovl)-2-( 1
. 1-dimethylcthyl)hvdrazidc CAS# 161050-58-4 End-use product (EP) Intrepid 2F In secticide (EPA R egistration #627 19-442) TABLEA.2 P h ys icoc h e mi ca l Pro p e r ties o f Me th ox y f e n oz id e. Para meter Va lue Reference Mcltine. point/ran!?,C 206
. 1-208 0231303 : 11. Podall: 19 May 19 97 pH 7.0 Den s ity {e./c m 3 ) 0. 7-10 ± 0.0081 Water solub ilitv ( mg/L 20 °C) 3.3

DP Barcode 0425285 ! MRI D #4942020 I Page 3of 10Methoxyfenoz ide/ 62719-442/ PC Code 121027/ Dow AgroSciences/ 62719 DACO 7.4.1 / 0P P TS 860. 1500 / 0ECD llA 6.3. 1, 6.3.2 , 6.3.3 and IllA 8.3.1, 8.3.2 , 8.3.3 Crop Field Trial/ Residue Dec lin e - C hive s (Leaves)

TABLE A.2 Ph ys icochemica l Pro p e r ti es of Metho xy fe n o z ide
. Param ete r Val u e R efere nce Solvent so lubility (g/L at 20° C) N-!-leptane 1.87 Xy l ene 3.38 1.2-dichlorocthane 36.72 Methano l 192.92 2-Propanol 50.22 Vaoour orcs s urc at 25 ° C 1.33 x IQ

- 5 Pa Di ssoc iation constant (pK.) Not app licable Octanol / wat er oartition coefficient (Log I Kow I) 3.72 ± 0.04 UV / visib l e absorption spec trum s 55313 at 203 nm European Commission; SANC0 / 10384/ 202

- rev . 4; 7 October 2004
B. E XPERIMENTAL DESIGN 

### B.l. Study Site Information
TABL E B.1.1 Tri al S i te Cond i tion s. Tri a l Identific ation N umber ; So il characteristics L ocation (C ity, S tate/ Y ea r ) T y p e % OM pH CEC ( meQ/ g) 07240. 12-CA * 17; Sa lin as , CA/20 12 Sandy Loam 1.8 6.5 8.9 07240. 12- CA* l 8; Sa linas. CA/2012 Sandy Loam 1.7 6.8 9.5 07240. 12-MD 04; Sa lisbury. MD/ 20 12 Loamy Sand 1.3 6.1 3.3 The actua l weather cond iti o n s during the r esidue study period were genera ll y co ns idered w ithi n average historical values for all tr ial s ites. Irri gat ion was used to supplement rainfall as needed. T he app li cation use pattern is summar i zed in Table B.1
. 2 , below
.
TABL E B.1.2 S tud y Use Pattern. App li cation Tria l ID #, Location E P 1 Spray Tot a l Tank Mi x (C ity, Stat e)/Yea r Method/Timing (G rowth S ta ge) Vo lume Rate RT I Rate (GPA) 2 (lb a i/A) (da ys) ( lb a i /A) Adjuvants I. Foliar directecl/3-4 tnae leaves 42 0.250 

## - 07240. 12- CA * 17
. Intrepid 2. Foliar directed /4-5 true leaves 42 0.248 IO 1.00 R-11 NIS Sa linas. CA/20 12 2F 3. Fol iar directecl/4-6 true leaves 48 0.249 9 4. Fo liar directed / 6

- 9 tnac leaves 51 0.257 11 I. Fo liar broadcast / 3-5 true l eaves 26 0.247 

### - 07240. 12- CA * 18 , I ntrepid 2. Foliar broadcast /4-5 true leaves 27 0.249 9 0.998 R- 11 N IS Salinas. CA/20 12 2F 3. Fo liar broadcast / 5-8 true leaves 29 0.252 11 4
. Fo li ar broadcast / 6 -1 0 true leaves 30 0.250 9

DP Barcode D425285/MRID #49420201 Page 4of10Methoxyfcnozide/ 62719-442/PC Code 121027 / Dow Agr oScien ce s/62719 D ACO 7.4.1 / 0PPTS 860.1500 / 0ECD ll A 6.3.1. 6.3.2
. 6.3.3 and Ill A 8.3.1. 8.3.2. 8.3.3 Crop Field Trial/ Residue Decline

- Chives (Leaves)

TABLE B
. 1.2 St ud y U se Pattern. App lication Tr ia l ID #, Location E P 1 S pray Total (C ity, Sta t e)Near R a t e RT I M e th o dffimi ng (G rowth S t age) Vo lume (d ays) R a t e ( G PA ) 2 ( lb ai /A) ( lb a i /A) I. Foliar broadcast/ Full bloom 30 0.248


### - 0 7240
. 12

- MD04. Intrepid 2
. Foliar broadcas t/ End of bloom JO 0.248 10 0.994 Salisbury. MD/ 20 12 2F 3
. Foliar broadcasl/Post bloom 30 0.248 11 4. Fo liar broadcast/Post b l oom 30 0.250 8 I
. EP = End-use Product. 2. GP/\ = Gallons Per Acre.
TABLE B.1.3 Tri a l N umb e r s a nd Geographi c a l Lo c ati o n s Chiv es NA FT A Gro win g R eque s ted Z o n es S ubmitte d 

### us I IA 2 l 3 -I 5 SA 58 6 7 7A 8 9 10 2 11 12 13 14 15

D P Barcode D425285 / MR I D # 4942020 I Tank M ix Ad j u va nt s

De

- Fae 820 NIS

P age 5of 10Methoxyfenozide /62719-442/ PC Code 121027/Dow AgroSciences/62719 DACO 7.4.1 / 0PPTS 860.1500 / 0ECD ll A 6.3.1, 6.3.2 , 6.3.3 and lll A 8.3.1 , 8.3.2 , 8
. 3
. 3 Crop Field Tria l/Residue Decline

- Chives (Leaves)

T A BL E B. 1. 3 Tri a l N um bers a nd Geog ra p hi ca l Locat io n s 

# I C hi ves NAFT A Grow in g Zo n es 

# I Requ este d S ubmi tte d 

## us 16 17 18 19 20 21

- Total 3 Any3 B.2. Sa mpl e H a ndlin g a nd Prep a ration At each trial s ite , untreated ch ives ( leaves) were harvested before treated chives. Treated samp les of fresh chives and c h ives for drying were co ll ected one day following the final application. In the two California trials, the untreated samp les were harvested on the day of the last applicat ion . Handfuls of chives leaves were cut near the soil li ne from at least 12 areas of p lot , avo id ing the row ends and outer rows. Dead and senesced leaves were removed
. Sample bags containing chives were placed and he ld in separate coolers (treated and untreated) with blue ice. Samples of fresh chives were p laced in frozen storage on the day of harvest. 

### In order to obtain dry ch i ves , in each tri a l the samp les were held in a dryer for approximate ly 24 hours and then placed in frozen storage. All treated samples from eac h s ite were p laced in frozen storage within 50 minutes of sampl ing and were sh ipped frozen to the analytica l laboratory by ACDS freezer truck , arri ving frozen and intact at the IR-4 Western Region Laboratory (Davis , CA). Upon aniva l at the analytical laboratory , the samples were assigned unique sample numbers, and stored frozen until sample preparation
. Raw agricultural commodity (RAC) samples were processed for analysis by chopp ing wit h dry ice. The chopped samples were stored frozen (genera ll y -20 ° C) unt il extraction and analysis. B
. 3 . A n a ly t ica l M ethodolo gy The method used for sample analysis was derived from 

### Determinalion of Residues of Methox y fenozide in High Moisture Crops by Liqu id Chromatography with Tandem Mass Spectrometry Detection, S.L. By rn e and M.J. Hastings , Dow AgroSciences method GRM: 02.25 , dated 4 October 2002; and Rohm and Haas Report # 34

- 98-87 , t it led 

### Tolerance Enforcement Method.for Parent RH-2485 in Pome Fruit.

DP Barcode D425285 / MRID #49420201 Page 6of10Methox yfenoz ide/ 62719-442/PC Code 12 1027/ Dow AgroScie nces/627 1 9 DA CO 7.4. J /OPPTS 860. I500 /0ECD ll A 6.3.1. 6.3.2. 6.3.3 and lll A 8.3
. I, 8.3.2 , 8. 3.3 Crop Field Trial/ Re s idue Decline - Chives (Leaves)
Residues of mcthoxyfenozide were extracted from chives by homo ge ni zat ion with 90% methanol/I 0% 0.1 N HCI , then shaken and centrifuged. The extract was purified by solid phase extraction (S PE) usin g a n Evolute ABN S PE cartridge. Samples were analyzed by Liquid C hromatograph y with Tandem Mass Spectrometry D e t ec tion (LC/MS / MS). Based on recoveri es from sa mple s fo rtified at the LLMV , the LOO a nd LOQ for fresh leaves were 0.0016 ppm and 0.0048 ppm , and for dried leaves were 0.0146 and 0.0438 ppm , re spectively. Analyt ical sets ty pically consi s ted of calibration standards, unfortified controls , fortified co ntrol s , and treated s amples.


### C. RESULTS AND DI SCUSS IO N Control sampl es were fortified and a nal yzed both prior to , and concurrently with, the field trial samples. M ethod va lidation reco ve ri es o f methoxyfenoz id e from sampl es of fresh chives fortified at 0
. 0 I 0 ppm to 10 ppm ranged fr o m 83-91 % ( 86 ± 2. 7%. n = 9). Concurrent recoveries from s ampl es of fresh chi ves fortified ·with methoxyfenozide at 0.0 10 ppm to 20 ppm we re in the ran ge from 84-98 % (92 ± 5
. 8 %, n 

### = 7 )
. Method val idati on recoveries of methoxyfenozide from samp le s of dried chive s for tifi ed at 0.050 ppm t o 50 ppm ranged from 85- 89 % (87 ± 1.5% , n = 9). Co ncunent recov e ri es from dried ch i ves fortified at 0.050 ppm to 200 ppm ranged from 81-106 % (92 

### ± 11 %, n= 7)
. Method va lid ati o n and concurrent recov e ry res ults are summarized in Table C.1 , below. Methoxyfe nozide residues in control samples of fresh and dried chives were < 0.0 1 0 ppm and < 0.050 ppm , re spect ive ly. A fi ve -point s ta nd a rd cu r ve was gene rate d by inj ec ting constant vo lume s of standard so luti ons each time an analytica l set was run. The corre lation coefficient was always reporte d to be 2: 0.999.
TABLE C.1 Summary of Recoveries of Methoxyfenoz id e fr o m C hi ves ( L eaves) Matrix Ana l y t e S r >ike level Samp le s ize Ty p e of R ecove ri es Mean ± s td
. dc v. (r>pm) (n) Recov e r y (%) (%)4 MV 1 91. 88. 88 89 ± 2 0.0 10 6 CR: 97.97. 98 97 ± I C hive s 0.30 3 MV 85.84. 84 84 ± I (Fres h Methoxyfcnozidc 2.0 3 SSC R3 89.93. 92 9 1 ± 2 Leaves) MV 84. 83.84 84 ± I 10 4 CR 9 1 9 1 20 3 C R 88. 84
. 86 86 ± 2

DP Barcode 0425 2 85 / MRID #4942 0201 Page 7of10

# ··**·** TABLE C .I Methox yfe nozide/62719-442/PC Code 121027/ Dow AgroSciences/ 62719 DACO 7.4.1 /0PPTS 860
. 1500 /0ECD llA 6.3.1, 6.3.2, 6.3.3 and lllA 8.3.1 , 8.3.2 , 8.3.3 Crop Field Trial/ Res idue Decline

- C hive s (Leaves)

S umm ary o f R ecoveri es of M eth oxyfe n oz id e fr o m C hi ves (Leaves) Matrix A n a l yte S pike leve l Sa m p le s ize T ype of Recoveries Mea n ± std.dev. ( p p m) ( n ) R ecove r y (%) (%)4 C hive s MV 87
. 88. 89 88 ± I ( Dried 0
. 050 6 Leave s) CR 106, 102. 1 03 104 ± 2 MV 86. 85. 85 85 ± I 2.0 6 Me thox y feno z idc SS C R 90.88. 88 89 ± 1 MV 86. 85
. 88 86 ± 2 50 4 C R 92 92 200 3 C R 82. 81. 81 8 1 ± I I. MV = Me thod Validation recove ries. 2. C R = Co ncurre nt Recoveries
. 3. SSCR = Storage Stabi lity Concurren t Reco ve ri es 4. Standard d e viation i s not calculated for sam pl e se ts with n < 3. 

### Chives samples were stored frozen for up to 119 days (fresh leaves) and 122 days (dried leaves) after collection. A freezer storage stab ility study was conducted using samples of chives fortified with 2
. 00 ppm methoxyfenozide , and stored for 110 days (fres h leaves) and 112 days (dried leaves)
. Concurrent recoveries ofmethoxyfenozide during analys i s of storage stability samples of fresh leaves and dried leaves were in the range 89-93% (91 ± 2%, n = 3) and 88

- 90 % (89 ± l %, n 

## = 3) , respective ly . Recoveries from stored chives fortified with methoxyfenozide at 2
. 00 ppm ranged from 91-93 % (92 ± 

### 1.1 %, n = 3) and 86

- 87% (86 ± 

### 0.6% , n 

## = 3) for fresh and dried chives, respectively (see Tab le C.2 , below). Fo ll owing four foliar directed or fo li ar broadcast applications of Intrepid 2F to chives plants at a tota l seasonal rate of approximately 1.0 lb ai/A at 8 to 11-day RTis , and a 1-day PHI, the maximum methoxyfenozide residues were 13 ppm in fresh leaves, and 118 ppm in dried leaves (fie ld trial 07240.12-CA

## * 17). No detectable residues were found in control samples. The residue trials were not adversely impacted b y the fanning practices or environmental conditions of the trial s. Crops were grown and maintained according to typica l agricultural practices for each geograph ical region. Irrigation was used to supplement moisture avail able from precipitation , as needed
. The selected sites provided an appropriate range of soi l types , and the crop varieties selected were typica l for commercial production in each area . Weather conditions at the field sites were generally considered nonnal , and no anomalous events were recorded. The residue results are presented in Tab l es C.3 and C.4 , below.

DP Barcode 0425285 / MRID #4942020 1 Page 8of10Methoxyfenozide/62719

-442/PC Code 121027/ D ow AgroSc ience s/ 62719 DACO 7.4.1 / 0PPTS 860.1500 / 0ECD II A 6.3.1
. 6.3.2
. 6.3.3 and lll A 8.3.1. 8.3.2. 8.3.3 Crop Fie ld Trial/ Residue Decline

- C hi ves (Leaves)

TABLE C.2 Su mm ary o f Storage Co nditi o n s.

Matri x (RAC Anal y te Storage Temr >. Actua l Storage Interva l of Demon s trated Storag e S tability or Extract) ( " C) Duratio n ( Days) Storage Stabi li t y ( Days) Recoveries (%)

C hives Methoxy fcn oz idc <-2 0 ° C 119 I I O 9 I. 9 I. 93 ( Fres h Leaves) C hives Meth oxy fcno z ide <- 20° C ( Dried Leaves) 1 22 I 12 86.86.87

TABLE C.3 Res idu e Data fr o m C hi ve Fie ld Trial s w ith Meth oxyfenoz ide. E P A Trial 10 / (City, Co mmodity Grow in g Cro p/Variety Tota l Rate PH I Mcthox y fenozide S tate)Near Re g ion or Matri x ( lbs ai/ A) (da ys) (p pm ) 0 7240. 12-CA * I7/ Fre s h I.caves 1.0 I 13. 12

alin as . CN 2 0 12 I O C hives/Purly Dried Leave s 1.0 I I 12. I 18 0 724 0. 12-CA* 18/ Fre sh Leaves 1. 0 I 6.6. 6.8

alinas . CN 2012 10 Chive s/Staro Dried Leave s 1.0 I 63
. 65 07240
. 12-MD04/ Fre sh Leaves 1.0 I 7.4. 5. 7 Sali sbury. MD/ 20 12 2 Chives/F ancy Dried Leaves 1.0 I 1 3. 12
TABLE C.4 S ummary of Mcth ox y fenozide Res idu e Data from C hi ve Field Tria ls. T otal U se Pill Resid ue Leve ls (p pm ) Co mm od i ty Anal y t e Rate (da ys) ( lb s ai /A) n Min. Max. HAF'P Media n Mean Std. D ev. Chi v e s Mcthox y fcn oz ide ( Fre sh Leaves ) 1.0 I 6 5
. 7 13 12
. 5 7
. 1 8.6 3
. 1 Chives Met hoxyfcnozide 1. 0 I 6 12 11 8 11 5 64 64 46 (Dried Leaves) • I IAFT = I l1 ghes1 Average 1' 1 cld T ri al.


### D. CONCLUS I ON The study was co nducte d consi s tent w ith s ta ndard agricultur al prac tic es a s per propo se d expe rimental de s ig n s. T he number and geograph ical distribution of th e s upervi se d crop fi e ld trials on chives a re ad equate. Weather condition s a t the field si te s were ge n era ll y considered normal and n o anomalou s events were rec o rd ed. The LC/ M S/MS method u se d for determining metho xyfe no z ide r es idu es in chives ( lea ves) was adequate for data co llection. Fo ll ow in g fo ur fol iar a pplic at io n s at a ta rgeted rate of 0.25 lb ai/ A per app li ca ti o n. for a total seasona l u se rate of approximately 1 .0 lb ai/ A
. and a I -day 

### PHI , maximum mcthoxyfe nozide residues were 1 3 ppm in fres h c hi ves ( leaves ), and 118 ppm in dried chives ( le aves). An adjuvant was inc luded in each tank mi x at a ll trial sites. The s ubmitted stor age s tab ilit y data indicated th a t th e residues were stable und e r the conditi ons at wh ich s amples we re he ld between s amplin g a nd a n alysis.

O P Barcode 0425285 /MRIO #4942020 I Page 9 o f 10Methoxyf enozide/62719-442/ PC Code 121027/ Dow AgroScience s/62719 DACO 7.4.1 / 0PPTS 860
. 1500 / 0ECD !I A 6.3.1 , 6.3 .2, 6.3.3 and IllA 8.3.1 , 8.3.2 , 8.3.3 Crop Fie ld Trial/ Re s idue Decline

- Ch ives (Leaves)



### E . REFERENCES l ) D231303 ; H. Podall; 19 May 1997. 2) European Commission , Health & Consumer Protection Directorate General ; 

### Revie"v11 Reportfor the active ingredient Methoxyfenozide; 7 October 2004.
F. DO CU ME N T TRACKING Petition Number: 4£8298 DP Barcode: D425285 PC Code: 121027

DP Barcode 0425285/MR ID #49420201 Page 10of10