### UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON , D .C. 20460

MEMORANDUM DAT E: 

### 09/ 17 /15 OFF I CE OF C HEMI C AL SAFETY A ND POLLUTION PREVENTION



### SU BJE CT : 

### Zoxamid e. Tolerance Petition fo r New Uses on G inseng , Toma t o S ub gro up 8

- 1 OA; 

### Small Frui t , Vine C lim b ing , Except Fuzzy Kiwifruit , S ub group 13-07F ; and Tuberou s and Co rm Vegetab le Subgroup lC. Summary of Analyt ical Chemi s try and R es idu e Data. P C Co de: I 

### 01 7 02 D ec i sio n No. : 

### 498225 P etiti o n No.: 

### 4E8335 Ri s k Assessment Type: 

### NA TXR No
. : 

### NA MRID 

### N o.: 

### NA DP B a r codc: 

### D429154 R eg i s tra tion No.: 

### 1016 3 -6414 R eg ulat ory Action: 

### Section 3 R eg istration Case No.: 

### NA CAS 

### No.: 

### 156052-68-5 40 C FR : 

### 180.567
FROM: 

### Meheret Neg u ss ie, Chemist 

### /'1ehere;f-**~~ e_**  

### Ri sk Assess m ent Branch III {/ 

### Health Effects Di v ision ( HE D 7509P) THROUGH: 

### Donald Wilbur, Senior Chemis t

# d:y}-~~ C hri st in e Olinger, Branch Ch ief , 1 

# j Risk Assessment Branch III 

## L/ Health Eff ec ts Division (HED 7509P ) TO : 

### Barbar a Madden , Team Leader ; And r ew Ertman, Biol og is t Min o r Use a nd Emergency R espo nse Branch (MUE RB ); a nd To ny Ki s h ( PM ), Marcel Howard , Production Manag em e nt Team #22 R

eg is tra ti o n Division (7505P )

Page 1 

### of 13Zoxamidc Summary of Analytical Chemistry and Re s idue Data DP # : 4 29 154 Executive Summary Zoxamide is a broad-spectrum pro t ec t a nt fungicide regi ste red for u se on p o ta toes, grapes, tomatoes , and c u c urbit vegetab l es . Tolerances for residues of zoxa mide have been estab li shed under 40 CFR 

### § l 80.567(a)( 1) on grape a t 3.0 ppm , grape , r a i s in at 15.0 ppm , tomato at 2.0 ppm , a nd vegetab le, c u cu rbit , gro u p 9 at 1.0 ppm. To le ranc es a re es tabli s h e d und e r 40 CFR § 180. 567(a)(2) for th e combined re s idu es of zoxamide and its m etabo lit es on the onion , bu lb , subgroup 3-07 A at 0.7 ppm , potato at 0.060 ppm , pota t o, gra nules/flake s al 0.30 ppm , and potato , wet pee l at 0. 1 0 ppm. The Int erreg ional Research Project Numbe r 4 ( IR -4), on beha l f of th e Agr icultural Experiment Stat io n of th e sta t e of Mi chiga n , ha s s ubmitt ed a Sec tion 3 reg i stra tion request for a new u se in/on g in se n g and has proposed ex pandin g the ex i stin g t o lera n ces on p o tato , to m a t o, and grape t o the vegetab le , tuberous and corm , subgroup IC ; t o m ato subgroup 8 -1 OA; and th e fruit, sma ll vine c limbin g, except fuzzy kiwifruit , subgroup 13-07F , respectiv e ly. IR- 4 petitioned for the translation of the existing zoxam i de potato , granules / flakes tolerance of 0
. 30 ppm to ginseng w ith o ut submitt in g a n y residue data o n g in se n g . T he tran s l ation was approved by ChemSAC (C h e m SAC minute s dated 09/ 11/13 and 09118/13. In addition, I R

- 4 requests remova l of th e established tolerance s for the fo ll owing commodi ti es upon estab li s hment of th e crop s ubgroup tolerances: grape (3.0 ppm ), tomato (2.0 ppm), and potato (0.06 ppm). In conjunction w ith thi s p e titi on, an amended labe l of the 75% w ate r d i spe r s i b le gra nule (WOO) formulation ofzoxamid e (Gave l ® 75DF Fun g ic ide ; EPA Reg. No. 1016 3-64 1 4) was s u bmitted to add u ses on g in seng and reflect the crop group expansion. Gavel 75 DF ag ri cultural fungicide i s a mixture of 8.3% zoxamide and 66. 7 % mancozeb. On ly zoxan1ide is eva l uated in thi s assessment. The product i s proposed fo r up to s ix fo li ar applica ti ons at 0.12-0.17 lbs ai/ A/applicat io n for a total seaso nal application rate of 0.96 lb a i/ A, w ith a prcharvest int erva l ( PHI ) of 28 da ys. The proposed u se patt e rn fo r g in se n g i s s imi ta r t o th e ex i s tin g reg i ste red use fo r potato , excep t for the PHI ( 1 4 days for potato). Adequate metabolism stud ie s o n potatoe s, grapes, cucumbers , and tomatoe s are available. The residue of concern for tolerance sett in g and risk assessmen t i s zox a111ide fo r grapes , grape processed co mm od itie s, t o m atoes, and cucumbers. Th e res idu e of concern fo r to leran ce settin g and ri sk assess m e nt i s zoxa mid e a nd it s m e tab o li tes ( RH-1 452 and RH-14 55) i n/on potatoes a nd processed pota t oes . The proposed use on g inseng and the c rop subgro up expansions of zoxamide do n ot alter th e Agency 's p rev io u s conc lu s ion that there i s n o reasonab le expec t ation of finit e re sid ues in rumin an t a nd poultry commod iti es [Category 3 of§ 180. 6(a)]. Adeq u a t e a n a l yt ica l method s a r e availab l e for enforcing zoxa mide to lerances and co ll ecti n g data on res idues in plan t commodities. Th e analyt ical methods , gas chromatography w i th electron capture detection (GC / ECD) and GC with mass se lect ive detect io n ( GC/MSD) are available for tolerance enforcemen t for plant commod iti es as primary and co nfirm a t ory method s, respec tively. P age 2of 1 3Zoxa mide Summary of Analyt ical Chemistry and R es idue Data DP # : 429154 

### Fo r th e acid metabolites ( RI-1-1452 and RH-1455) , the GC /MS D is th e primary method and the GC/ ECD method is the confirmatory me th o d. Th e methods have bee n adequatel y va lidated for the determ inat i on o f r esidues of zox amid e in plant com moditie s . Ad e quate multi res id ue methods testing dat a h ave bee n s ubmitt ed
. The da t a indicate that th e multiresidue methods are adequate fo r enforcement of to lera nc es for zoxam id e only. Fo r g in se ng , the Analytica l C he mistry Branch (ACB) / Biolo g ica l and Eco nomic Analysis Division ( B EA D ) ha s s uc cessfully developed an analytical method which can be used for e n fo rc eme nt purposes. Th e re sid ues are quantified by high-p erform ance li quid c hromato g ra ph y with tand e m mas s s pectrom e try (LC

- M S/ MS). Th e method ha s been adequately va li date d fo r the de termin ation of residues of zoxa mid e and i ts me t a boli te s . Adequate s t o rag e s tab ility data are ava il a b le to s upport storage conditions and int e rva ls for the r eg is tered c rops and the prop ose d g in seng u se . The r es idu e definitions are ha rmonized for the U.S. a nd Canada
. The U.S
. and Canadian re sid ue d e finition s inc lud e zoxa mid e for grapes and proc esse d grapes and zoxamide and its metabo l ites (RH -14 52 and RI-1-14 55) for potatoes a nd proc essed po tat oe s . Th e Codex res idu e definition includes the parent zoxam id e only for a ll cro p s, a nd is therefore not harmo niz ed wi th the tol erance ex pression for certa in U .S. commodi ti es. The tol erance r ecommendation for Tomato subgroup 8-1 

### OA at 2.0 

### ppm is harmonized wi th a Ca nadi a n maximum res idu e limit (M RL ) on tomat oes at 2 

### ppm and a Code x MRL on tomato es at 2 

### ppm . A 

### toleran ce was proposed and r ec omm e nd e d in or o n Small vine climb ing fruit , exce pt fuzzy kiwifruit , subgroup l 3-07F 

### at 5
. 0 

### ppm , in order to harmon ize w ith an es t ab li s hed Codex MRL on gra pe at 5 

### ppm. The in c rea sed U.S
. 

### tol era nce r ecom me ndati on o n s ub gro up 13-07 F a t 5 .0 ppm re s u lts in a lack of harmoni za t ion w ith an establish e d Canadia n MRL on g rape at 3.0 ppm. Th e to leranc e r eco mm enda tion for tuberou s and conn vege tabl e s ubgroup IC at 0.06 ppm is harmoni z ed w ith a Ca nadi an MRL establ i shed on potato at 0.06 ppm ; however , the U.S. t o lera nce is not ha rm o nized wi th a Codex MRL at 0.02 

### ppm . The und e rlying res idue data a nd r es idu e de finition u sed to s upport the Subgroup 1 

### C to lerance s upport s a to lerance recommendatio n that is higher than th e es tab li s hed Codex M R L o n potato at 0.02 

### ppm. Th ere are no Codex or Canad i an MRLs fo r g in se ng. A n Int ern a ti o na l Res idu e Limit S ta tu s sheet is attach e d (A ttachmen t IT ). R eg ulat ory R eco mm e nd a ti o n s a nd R es idue C h e mi s t ry D e fi c i e nci es 

### HE D ha s exa min e d the res idu e chemistry databa ses for zoxamide
. P e ndin g subm iss ion of a re v ised Section 

### B, as we ll as the s ubmitt a l of a n aly ti ca l reference s tand ards as li sted below , there are no is s ues that wo uld prec lud e the es t ab li s hment of the recommended tolerances. Specific tolerance reco mmendatio n s ar c listed be low on Table 2
. 2.2.

Page 3of 13Zoxa mid e Summary of Ana lytical C hemi s try and Re s idu e Data DP # : 429154 T ab le 2.2.2 T o le r a n ce**Summar ~**  for Z-Oxam id e Propo sed R eco mmended Co rrect Co mmodity Co mmodity To lera nce To le r ance (ppm) Definition / Co mm ents ( ppm ) T o be es tabli s hed und e r 40 CFR & 1 80.567 (a) Genera l. (I) Tomato s ub gro up 8-1 OA 2 .0 2 .0 Established to l e rance fo r tom a t o s hould be removed fr o m th e 40CFR and replaced b y this subg ro up tolerance
. 17ru it , s mall , vine climbin g, except 5.0 5.0 Fruit, s mall vine climbing. excep t fuzzy kiwifruit , S ub group I 3-07F fuzzy ki111ifruit , subgroup 1 3-07F Es t ab li s hed toleranc e fo r grape s hould be rem oved from th e 40CFR and repla ce d by thi s s ub g r oup toleranc e. I n c r ease to l e r an ce to har111 011i::. e 111ith Codex. To be es tabli s h e d und e r 40 C FR & 1 80 .5 67 (a) Gene r al. (2) Vegetab l e , tub ero us a nd corm, 0.060 0.06 Veg e ta b l e, tu be ro u s and com1, S ub group I C subgroup IC Es t abli s hed toleranc e for pot ato should be remov ed from the 40Cl7R a nd repl aced by thi s s ub gro up t o lerance. G in se ng 0.3 0.30 Establi s h toleranc e ba se d on p otato granules/flakes data A human health ri sk assess m e nt i s fo rth co ming. 

### Note to PM: In 

### conjunction with es tabli s hment of the above tolerances , the e xi s ting tolerance s for g rap e, tomato , and potato ne ed to be removed from 40 CFR §18 0.567 (a) as indicated above
. 860. 1 200 Directi o n s fo r Use

• The propo sed u se dir ec tions fo r Gave l ® 75DF Fungic id e ( EPA Reg . No
. I 0 163-641 4) s h o uld be revised to include only g insen g a nd Toma t o subgroup 8- l OA. Referenc e to th e fo ll ow in g co mmoditi es s hould be r e mov e d , as the re g i s trant ha s w ithdra w n th ese proposed reg i s tration s: S m all v in e c lim bi n g fruit, exce pt fuzz y kiwifrui t , s ubgroup l 3

- 07F , excep t fo r the pr ev iousl y- reg i s tered u se on grape; and Tub e rous and co rm vege t ab le s ub gro up l C , excep t fo r the prev io u s ly -reg i s t e red u se on pot a t o . 860 .1 650 S ubmitt a l of Analytical R efe r e n ce Standard s

• T h e ana ly ti cal refe r e n ce s tand a r d fo r zoxam ide m etabo li tes ( RH 1 452 and RH 1455 ) a nd d e rivat i ves ( RH 147 39 1 and RH 147399 ) i s exp i red o r i s availab le only in I gram (pe r so nal email w i th Teresa Col e, ACB , 1 1 /l6/ 2015). The regi s tra nt is requ ire d to s ubmit a r easona bl e am o unt of the ana lyt ica l refere nc e s tand a rd for the metabolites and d eri va ti ves.

P age 4of 1 3Zoxamide Su mm ar y of Ana l y

ti ca l Chem is try and Residue Data DP #: 429 154 B ac k g ro und 

### Th e chemical names and structu res of zoxa mide and the acid me tabolites RH-1 452 and RH-1455 are presented in Tab l e I
. The physicochemical propertie s of th e tec hni ca l gra d e of zoxam id e are presented in Tab le 2.
T ab le I. Zoxa m id e Nome n c lat u re. Chemical structure 0 C l**~** 

# I N Cl H**~** 0 Cl Com m on name Zoxamide Company experimental nam e RH-7281 IUPAC name ( RS)-3,5-dichloro - N -(3-chloro-1-ethyl-1-mcthyl-2-oxopropyl ) -p-toluamide Mo l ecular weig h t 336
. 64 g/ mol CAS n ame 3.5-di ch loro

-.V

- (3 -chloro- l- cthyl -1- mcth y l-2-oxoprop y l ) -4-meth y lben za mide CAS registry number I 56 052 -68

- 5 End-u se product (EP) Gavel ® 75DF Fun g i cidc (EPA Reg. No
. I 0 16 3-64 1 4) (This produc t is a combination of zo xa mide + manc oze b
. Onl y loxamidc re s idues have been determined .) Chemical stru cture CO,H**~** 

# I # C ' 

### a**~O H**  Common name Rll-1 41452 Company experimental name RH-1-152 C hemi cal nam e 3.5-dichloro-4-hydroxymethylbe nzoic acid Molecular wei g ht 22 1 .0 4 g/ mol CAS Name No t avai lab le



### Page 5of13Zoxarnide Summary of Ana l yti ca l C he mi s try and R esid ue Data DP #: 429 1 54
T ab le 1. Zoxam id c N om encla tur e. C hemical st ru cture
Cl HO 

## \_o 

# c

H O I ' 0 C l Co mm o n name Rll-1414 55 Company experimental name Rll-1455 Chemica l name 2.6

- dichlorobcn zene-1.4-dicarboxylic acid Mo l ecular wei g ht 235 .02 g/ mol CAS Name Not avai labl e Tab le 2. Ph ys icoc h e mica l Pr o p erti es or Zoxam id c. Param e te r Va lu e R efere nce Meltin g point/ran ge I S9.S

- 1 60.S ° C (98.8 % purit y) MRID 49067102 pl I 6.9 al 24
. 3 °C Den s it y Relative Den s ity 1
. 38 at 20 ° C Water so lubility (al 20 ° C) 0.68 1 ±0 .017 mg/L Solvent so lubilit y (a t 20 ° C) Et h y l ace tate : 20.0 g/L Acetone : SS
. 7 g/ L X

y lene : 1
. 56 g/ L n-Octanol : 6.49 g/L n-Heptanc : 0
. 038 g/L 1 .2 -Di chloroet h anc : 12
. S g/ L Vapor pressure (at 25, 35. and 45 ° C) < 1.3 x**O· ~**  Pa Di ssociut i on consta nt , pK
. Not meas urnble by spec trophotometry , titration or conduc ti vi t y. Absorbance did not change in acidic. neutral. or basic conditions: Sol ubilit y was too low for titrati o n: with dec re ase in co nc e nt ratio n, no in crease in readin g wa s obse rved
. Octan ol/ water partition coefficient. Log Kow 3.76 ± 0.04 at ambient temp K

ow UV / vi s ib l e ab s orption spec tr um 2 12 nm . t 

### = 46330 

### 860.1200 Directi on s fo r Use The proposed u se directions fo r Gavel ® 75 DF Fun g icid e (E P A R eg . No. 1 0 16 3-6 41 4) s h ould be revi se d to in clude o nl y g ins e n g and Tomato subgroup 8- 1 OA. Re fe r ence t o the following co mm od iti es s h o uld be removed, as the re g i s trant ha s w ithdrawn th ese prop ose d r eg i s trati o n s: Small v ine c limbin g fruit , except fuzzy kiwifrui t , subgroup 13-07F , except for the prev i ously

regi s te r ed u se o n g r ape ; and Tuberous and corm vege t ab le s ub g roup l C, exce pt for the previous ly- r eg i stered use on potato.

P age 6o f1 3Zoxamide Summary of Analytical Chemistry and Residue Data DP #: 429154 860 . 1300 Natur e of the Re s idue - Plants R

esidue Chemistry Memo DP # 237892, 1 /10/2001, A. Acierto Re s idue Chemistry Memo DP # s 266 181 , 0268774, 4/02 /200 I , A. Acierto 

### Adequate metabo li sm studies o n potatoes , grapes, c ucu m be r s, and t oma t oes are ava il ab le. The HED's Metabo lism Assessment Review Committee (MARC) determined that the res idue of concern for tolerance setting and ris k assessment is zoxam ide for grapes and grape processed commodities and is zoxamide and its metabolites ( RH

- 1452 and RH-1455) in/on potatoes (Memo, A
. M. Acierto & 

### W.D. Wassell , 12118/2000, 0270797). The data concerning the metabolism of zoxamide in / on tomatoes and cucumbers were not presented to the MARC ; however, HED previously concluded that the residue of concern in tomatoes and cucurbit vege t ab l es for to lerances and risk assessment is zoxarnide. The nature of the residue of zoxa mide on ginseng is understood based on available metabolism studies. Conclusions
. 

### T he natu re of th e res id ue is adequa t ely defined for gin seng, the to mato s u bgroup 8- 1

OA, the fruit , small vine climbing, except fuzzy kiwifruit , subgroup I 3-07F; and the vegetab le, tuberous and corm, subgroup IC. The residue of concern for the tolerance and for ri sk assessment is zoxamide, except for subgroup 1 

### C. The residue of concern for the vegetable, tub erous and corm, subgroup I C fo r the tolera nce and risk assessme nt is zoxam ide and it s metabo li t es (RH- 1 452 and RH- I455). 860 . 1300 Nat ure o f th e R es idu e - Liv es t oc k R

es idu e Chemistry Memo DP # 0277097, 12/ 18/ 2000, A. Acierto Re s idue Chemistry Memo DP # 237892, 1 / 10/200 1 , W. Wasse l l, A. Ac ierto 

### Ruminants: An acceptable metabo lism study on goa t s is available. The MARC did not determine the residue of concern in rum ina nts s ince H ED 

### has concl uded that li vestock t o lera nces are not needed at this time. H ED has concluded that tolerances for seco ndary residues in milk and ruminant tissues are not required at this time and the uses can be cons ide r ed category 3 of 40 CF R §I 80.6(a). It is not poss ib le to dete r mine w ith certa in ty whethe r fini te r es idues wi ll be incurred, bu t there is no reasonable expectation of finite residues in mi l k and ruminant t issues.

Page 7 

### of 13Zoxamide Summary of Analytical Chemistry and R esidue Data DP # : 429154 P o ultry: A poultry m e tabo li s m s tud y ha s not been s ubmitted. Th e re are n o poultry feed it ems associated wi th the re g i ste red/proposed uses of zoxamide. Therefore , a poultr y m e tab o li s m s tudy is not re quired. How eve r , if any crops which h ave poultry feed it e m s are adde d in the future, th en a poultry metaboli s m study w ill b e required. 

### Concl usions. Re s idu es are n ot expec t ed to occ ur in livestock commodities from th e registere d and proposed u ses . The se uses fall under 40 CFR § I 80.6(a)(3). 860.1340 R es idu e A n a l y tic a l Method s R

esi du e C hemi s try Memo DP # 237892 , I / I0 / 200 I , A. Acieno Re s idue Chemistry Memo DP # s 266 181 , D268 774, 4/ 02 /200 I , A. Acieno Plant commodity method s 

### Enforcement m e thod: A gas chro m a t ograp h y method u s ing elec tro n captur e detect io n ( G C / ECO) as th e prima1y m e th o d and a GC w ith mas s se lecti ve detection (GC/MS D ) as the confi rmat o r y m e th o d are availab le for tol e rance enforcement for plant commod iti es. Adequate m e thod va lid a tion , radi ova lidation , and indep e nd e nt m e thod validation hav e been submitted for th e primary and con firmato ry m ethods
. For th e two acid metabo lite s , RH-1452 and RH-1455 , i n/o n potato tube r s and potato pro cessed fraction s, the GC/MS O meth od is proposed as the primary m e thod and th e GC/ ECO m e th od as th e co nfirmat o ry m e thod
. The GC/ ECO and GC/MSD m e th o d s were va lidated b y th e ACB /BEAD. After validation b y ACB , the enforcement m e th o d s we r e forwarded to FD A ( DP # 0 2 8439 4, 0 284396 , 0284398 , and 028400). For g in se ng , th e AC B ha ve s u ccessfu ll y developed an a n a lytical m e th o d which can be u se d for e nforcement purposes. The res idues a re quantified by hi g h-performanc e liquid c hroma to graphy w ith tandem m ass s pectrom e try (LC -M S/ MS). Th e method h as been adequat e ly va lidate d fo r th e det e rmination of residues of zoxa mide a nd it s me tab o lit es . Live s tock commodity method s H E D h as conclud e d that , ba se d o n the regi s tered u ses , res idue analytical m et h o d s fo r animal com m o diti es a re not required for this petition. 

### Co nclusions. Th e r esidue analytical m ethod s for p l ants are adequate. Acceptab le method s a re ava il ab le for t o lerance e n fo r ce ment purp oses for the re s idues of co n ce rn i nio n plant co mm odit ies. 860.1360 Mu lti rcsidue Methods R

esidue C hemis try M e m o DP # 237892 , 1 110 /200 1 , A. Acierto The pe tition e r ha s prev io u s ly s ubmitt ed data pertainin g to the multiresidue method s testing of zoxa mide and it s m e tab o lites ( RH-145 2 and RH-1455 ) in conjunction w ith PP # 9F05058. The multir es idu e methods dat a indi cate that zox amide was s uccessfull y recove red u s in g Pro tocols 0 a n d 

### E , w hil e n o n e of the prot oco l s successfu ll y r ecove r ed e ither of the m e tab o lit es. Th e MRM s are adequate for enfo rce m en t o f zoxami de tolerance s . T h e submiss io n h as been forwarded to
Pa ge 8of1 3Zoxamide Summary of Analytical Chemistry and Residue Data DP # : 429154 

### FDA fo r comp lete evaluat ion in conjunction w ith th e earli e r pe tit ion (02 55783, N. Dodd , 7/20/ 99). 860. 1380 Storage S t a bili ty Re s idue Chemistry Memo DP # 237892, 1/10 / 2001, A. Acie no Residue Chemis try Memo DP #s 266 1 8 1 , D268774, 4 / 02 /200 I , A. Acierto 

### Ba sed upon availab le data , residues of zoxamide in/on potatoes are stable during froze n sto r age fo r a period of 11.3 month s. B ase d on th e resu lt s of a successfu l radioval idat io n s tud y, re s idu es of the acid metabolites i n/o n potato tubers are s tab le under frozen sto rage cond iti ons for up to 29 months
. Potato crop fie ld tr ia l sa mpl es were sto r ed fr oze n for a peri o d of 12 t o 23 month s pr io r to analys is and potato processed commoditi es were stored frozen for a period of 12 mon ths pri or to analysis. Previously , adjustment of the potato processing data for storage d egradatio n prior to ana lys is was no t requi r ed
. Conclus ions
. 

### T he ava il able storage s tab ili ty da t a for zoxa mid e o n potatoes a re adequate to suppo rt the storage durations and condi ti ons of samp les of ginseng. 86 0
. 1400 Water , F i s h , and Irri g ated C rop s This gu ideli ne r equ ir e me nt is no r re leva nt to the current pe titi ons as th ere are no aquatic uses currently proposed for zoxa mide. 860.1460 Food H a ndlin g T hi s g uid e line r eq uirem e nt is not r elevant to th e current pet itions as th ere are no food hand lin g uses being proposed for zoxamide. 860.1480 Meat, Milk , Poultry , a nd Eggs Th e re a r e no a nim a l feed it e ms assoc iated wit h the new use inion g in se ng . The proposed use and the crop subgroup ex pansions of zoxamide addressed in thi s document do not alte r the Agency's previous conc lu s ion that there is no rea so n able expec t a tion of finite res idu es in ruminant and pou ltry commod iti es [Category 3 of§ I 80 .6 (a)]. 860 .1500 C rop F ield Trials R

esidue Chemistry Memo DP # 237892 , 1 / 10 / 2001, A. Acieno Re s idue Chemistry Memo DP ll s 266181, 0 268774, 4 /02 /200 I , A. Acierto 

### Crop subgroup expansions No new crop field tr ia l data we r e s ubmitt e d or a r e requ ired. The res idue d ata u sed to su pport established tolerances on the representative commodit ies are adeq uat e and may be used to sup port the tolerances on the crop subgroup convers ions. All new crops added by the crop s ub group ex pan s ions w ill be treated at th e same rate and t iming as the c urr e ntl y regis t er ed crops. G inse ng A toleranc e current ly exists for zox amide in/on potato g ran ules/flakes at 0.30 ppm (40 CFR 180.567). The proposed use pattern for gi n seng is s imil ar to the existing registered use fo r P age 9of13Zoxamide Summary of Analytical C hemi s try and R es idue Da ta potato , except for the PHI ( 14-days for potato). In additio n , the nature of the potato (g ranul es/fla ke s) and g in se ng are si milar : both are dri ed , s tarc h y, and root crops. DP t/ : 429 1 5 4

Furtherm o re , re s idue s in ginseng are ex pected lo be low e r th a n re s idues in potatoe s s ince g in seng h as a hi g h e r PH I a nd lowe r m ois ture content. The proposal for translating the p o ta to gra nule s/fla kes to lerance of 0.30 ppm to g in seng wa s approved by th e ChemSAC (09 / 20 1 3). P e r lR- 4 ' s reque s t , the ACB h ave successfully devel ope d an a nalytical m e th o d which can be us ed for enforcement purpo ses for th e a n a lys i s of zoxamide and it s metab o l ite s in / on g in se ng. T he m e thod was adequately va lidat ed o n g in se ng . 

### Conclusions
. Adequate field trial data are available to s upp o rt the propo sed crop subgroups and g in se ng reg i strations
. 

### 860.1520 Proce ss ed Foo d and Feed Proces s in g st udi es for th e cun- e ntly reg i ste red zoxamide u ses are adequate. No pro cessed food or feed is associated with th e requ es ted n ew u se o n ginseng. Zoxamid e proc essi ng s tudie s a re avai lab le for pot a toes and grapes. To le rances a re es tab li s h ed on potato wet peel , potato flakes and rai s in s . 

### 86 0
. 1650 S ubmittal of A n a l y tical R efe rence S tandard s Analytical s tandard for zox an1id e is current ly avai l ab le in the E PA Nat ion a l Pesticide S tand ards R e posit o r y; w ith expiration d ate o f 11 / 30 / 2019. Ho weve r , th e s tand a rds fo r zoxa mide metabo li t es (RHl452 and RH l 455) and derivatives ( Rl-1147391 and Rl-1147399) expired and / or ava ilabl e o nl y I g ram (pe r sonal e mail w ith T e resa Cole , ACB, l l / 1 6/ 2015). The reg i strant is r eq uired t o subm it a rea so nabl e amount of th e analytical refe re nce s tandard for th e metabolites and deri va tive s. The r efe renc e standard shou ld be sent to the Anal y tical Chem i stry Lab , which i s locate d a t Fort Meade, Maryland, to th e attenti on of ei th e r The re sa Co le o r T hu y Nguyen a t th e follow ing address: USE P A National Pesticid e Standards R e po s it ory/ Ana l y tical Chemist r y Branch / OP P 70 I M apes Ro ad Fort George G
. Meade , MD 20755 -5 350 ( Pl ease No t e th at the m a il will be re turn e d if th e extended z ip code i s not used.) 

### 860.1850 Co nfin e d Acc umulation in Rotati o nal C rop s Re s idue Chemistry Memo DP # 237892. 1 / 10 /200 I , A. Acierto R

es idu e C he mistry Memo DP # s 266181, 02 68774, 4/ 02 / 200 1 3, A. Acierto Acce ptabl e confined rotational c r op s tudi es were re v iewed in co njun c ti on w ith PP # 9 F 05058 o n r epresentative crops of mustard gree n s (leafy vegetab le), radi s hes and turnip s (root vegetables), so rg hum a nd wheat (ce r e al grains) and soybea n s (legume /oil seed ). Th e pare nt comp o und was not identifi e d in any rotational crop commodity at an y plantback int erva l. The m etabolit e RH-145 2 was t e ntati ve ly id e ntified at < 1-7 % of TRR (N 0- 0.0 11 ppm) Pa ge 10 o f1 3Zoxamide Summary of Analytical Chemistry and R esidue Data DP # : 429154 

### except in 30 -d ay PBJ s oybean forage w he r e it accoun t ed fo r 25% ofT RR (0.023 ppm). Bas ed o n th e results of th e reviewed co nfined rotational crop s tud y, it was concluded th a t th e r e is no indication that zoxamid e would be d etecte d in rotat iona l crops p l anted mo r e th a n 30 days after th e application of zoxa mi de. Conclus i on. 

### The 30 -d ay p lant-back interv a l (PBf) 

### s pec ified on the lab e l for rotated crops w i th o ut pr im ary uses of zoxamide i s adequate. 86 0
. 1 9 00 Fie ld Acc umu l at ion in Rot a t i o n a l C r op s R

es idue Chemi s try Mem o OP # 237 892 , I/ I 0/2 00 I , A
. Acierto R

es idu e Chemi s try M e m o DP # s 266181 , 0 268774 , 4 / 02 / 200 I , A
. Acierto 

### Based o n the re s u lts of the r ev iewed confi ned ro t ational crop st udy and th e dat a r equ irement s spec ified in OPPTS 860.1850, field accumula tion s tudies a r e not requir ed. 86 0
. 1550 Pr o p ose d T o l e r a n ces 

### Tolerances fo r residue s of z oxamide ha ve been es tabli shed under 40 CF R § 

### l 80.567(a)( 1 ) o n grape at 3
. 0 ppm , grape , raisi n at 1 5.0 ppm ; tomato at 2.0 ppm , and vege tab le , cuc urbit , gro up 9 a t 1 .0 ppm. Tolerance s ar e es tab li s h ed und er 40 C FR § 

### l 80.567 (a)(2) fo r th e co mbined re si du es of zoxa mid e and it s m e t

abo lit es RH

- 1452 a nd RH-14 55 o n onion , bu l b , s ub grou p 3-07A at 0.7 ppm ; pot ato at 0.060 ppm ; potato , granules/flakes a t 0.30 ppm ; and potato , we t peel at 0. 1 0 ppm.

T a bl e 3. T o le ran ce S umm a r y for Zoxa mid e Proposed R ecommended Co rr ec t Commodity Commodit y T oleranc e ( ppm ) T ol e rance ( ppm ) D e finition/Comments T o be es t ab l is h ed u nd er -t O C F R**80.567** (a) Ge n era l
. ( I) Tom ato s u bgroup 8-1 OA 2
. 0 2
. 0 Estab li s hed to le rance fo r tomato s hould be r e moved fr om th e 40CFR a nd r e pl aced b y th is s ub g ro up t o l

era nc e. Fruit , s mall , vine climbing , except 3.0 5.0 Fruit , small vin e climbing, exce pt fuz zy kiwifr uit
. Sub g roup I 3 -07F fu: zy kiwi fr uit, s ubg ro up 13-0 7 F Es tabli s he d tolerance for grape s hould be removed from th e 4 0 C FR a nd repl aced by this subgroup tol e rance . To b e estab li s h ed un der 40 CF R & 1 80.567 (a) G e n e ra l. (2) Vegetab le, tuberous and corm , 0.06 0.06 V ege table , tub erous and corm, S ub gro up I C subg r o u p I C Establi s hed t o l

e ra nce for toma to s ho uld be removed from the 40CFR and replaced by thi s subgroup t o lerance . Gin s en g 0.3 0
. 30 Ba s ed o m p otato granule s/flake s



### P age 11 o f 1 3Zoxamide 

### Refe re nc es 

### DP # : S ubj ect: From: To: Dated: DP# s : Subject: From: To: Dated: DP# s: Sub j ect: From: To: Dated : MR JD s: DP# : Subjec t: Fro m: To: Dated: MRJD s:
A tt ach m ent s: Summary of Anal yti cal C hemi s try and Residue Data DP # : 429154


### 277097 PP #9F05058 ; Zoxamide in/on Po t a t

o and Grapes. Conclusions of the l l /14/ 2000 Meeting of the Metaboli s m Assessment Review Committee
. A. 

### Ac ierto G. Kramer 12/ 18/ 2000 237892 PP #9F05058. Zoxam id e in/on Grapes and Potatoes . Review of Analytica l Methods and R es idu e Data . First F ood Use Review. A. Acierto Ro se K ea rn s/ Cy nthia Gile s -P a rk er 1 110 1 200 I 

### 266 181 and 268774 PP #OF06093. Zoxam id e i n/onToma toes a nd C ucu rbit s. Review of Ana lytical Methods and Resid u e Data. A. Acie rt o Rose Kearns/ Cynthia Giles-Parker 4/2/200 1 450 12 1 03to 45012118 276323 PP# 9F05058
. IO # 000707-00271 & 

### ID # 000707

- 00272: Zoxa mid e in / o n Grape s and Potatoes. A. Acie 1 10 Rose Kearns/ Cy nthia Giles-Parker 51 10 1 2003 

### 454 37802, 4 5 499801 ,45 46140 2 , and4546I403

Int ernationa l Residue Limit Status s heet Appe ndix I - To lerance Assessment Calcu lation s
Te mpl a t e V ersio n A pr i l 2008



### Pa ge 12of 13Zoxamide Summary of Ana l ytical Chemistry and Re s idue Data DP # : 429154 

## Intern ationa l Re si due Limits Zoxamide ( PC Code 101702 ) Summary of US and Internati o nal T o lerances and Maximum Re sid u e Limits R esidue D e /ini1ion: 

# us Canada Mexic o 2 Co dex 40 C FR 18 0. 567 (a)General Grapes and raisins: 3 ,5 -dichloro- Z oxamide N-(3-c hl o ro- I -cthyl-1-m eth y l-2- ( I ) 3 ,5-d ichloro-N-(3-chloro-1-cthyl- I- oxopropyl)-4-methylbenzamicle methyl-2- oxopropyl)-4-methy l benzamide Potatoes, potato processed (2) combined residues o f zoxa mid e and fractions (c hip s, flake s and its metabolites 3.5 -dichloro- 1 , 4- granules): b enzenedi ca rboxylic acid (RH- 1 455 and 3,5-dic hl oro-N-(3-chloro- 1 -ethylRH-1 4 1 455) and 3,5 -dichloro-4- I -methyl-2- hydroxymethylbenzoic acid (RH- 1 452 oxop ropyl)-4-me th y lb enzamide, and RH-141452 ) including the metabolite s 3,5 -di chloro-1 , 4- benzcnc-dicarboxyl ic ac id and 3,5-d ichloro- 4

- hydro xy methyl be nzo ic ac id 

### Commodity' Tolerance (00111) 

### / Max imum R esidue Limit (mf! /kf!) 

# us Canada Mexi co 2 Co dex Ginseng 0.30 0.3 potato flakes /granules Tomato s ubgro up 8-1 OA 2.0 2 to m a t

oes 2 tomatoes Frui t , s ma ll , vine c limbin g, 5 .0 3 grap es 5 gra pes excep t fuzzy kiwifr uit , s ub group 1 3

-07F Vegetable, tuberous and comi, 0.06 0.06 potatoes 0.02 subgroup 1 C po tato Completed: M. Negussie; 0 9/ 17/15
1 Includ es o nl y com moditi es of int e r es t for thi s ac ti on. Tolera nce values s hou ld be the HED recommendations and not those propo sed by the app li can t. 2 Mexico adopts US tolerance s and/or Codex MRLs for its expon purpo ses.

P age 1 3 of 13