UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

WASHINGTON, D.C. 20460 

MEMORANDUM 

DATE: 09/ 17/15 

OFFICE OF CHEMICAL SAFETY 

AND POLLUTION PREVENTION 

SUBJECT: Zoxamide. Tolerance Petition for New Uses on Ginseng, Tomato Subgroup 8-

1 OA; Small Fruit, Vine Climbing, Except Fuzzy Kiwifruit, Subgroup 13-07F; and 

Tuberous and Corm Vegetable Subgroup lC. Summary of Analytical Chemistry 

and Residue Data. 

PC Code: I 01 702 

Decision No.: 498225 

Petition No.: 4E8335 

Risk Assessment Type: NA 

TXR No.: NA 

MRID No.: NA 

DP Barcodc: D429154 

Registration No.: 10163-6414 

Regulatory Action: Section 3 Registration 

Case No.: NA 

CAS No.: 156052-68-5 

40 CFR: 180.567 

FROM: Meheret Negussie, Chemist /'1ehere;f- ~~e_ 

Risk Assessment Branch III {/ 

Health Effects Division (HED 7509P) 

THROUGH: Donald Wilbur, Senior Chemist d:y}-~~ Christine Olinger, Branch Chief ,

1 j 

Risk Assessment Branch III L / 

Health Effects Division (HED 7509P) 

TO: Barbara Madden, Team Leader; Andrew Ertman, Biologist 

Minor Use and Emergency Response Branch (MUERB); and 

Tony Kish (PM), Marcel Howard, Production Management Team #22 

Registration Division (7505P) 

Page 1 of 13 
Zoxamidc Summary of Analytical Chemistry and Residue Data DP#: 429 154 

Executive Summary 

Zoxamide is a broad-spectrum protectant fungicide registered for use on potatoes, grapes, 

tomatoes, and cucurbit vegetables. 

Tolerances for residues of zoxamide have been established under 40 CFR § l 80.567(a)( 1) on 

grape at 3.0 ppm, grape, raisin at 15.0 ppm, tomato at 2.0 ppm, and vegetable, cucurbit, group 9 

at 1.0 ppm. Tolerances are established under 40 CFR § 180.567(a)(2) for the combined residues 

of zoxamide and its metabolites on the onion, bulb, subgroup 3-07 A at 0.7 ppm, potato at 0.060 

ppm, potato, granules/flakes al 0.30 ppm, and potato, wet peel at 0. 10 ppm. 

The Interregional Research Project Number 4 (IR-4), on behalf of the Agricultural Experiment 

Station of the state of Mi chigan, has submitted a Section 3 registration request for a new use 

in/on ginseng and has proposed expanding the existing tolerances on potato, tomato, and grape to 

the vegetable, tuberous and corm, subgroup IC; tomato subgroup 8-1 OA; and the fruit, small vine 

climbing, except fuzzy kiwifruit, subgroup 13-07F, respectively. IR-4 petitioned for the 

translation of the existing zoxamide potato, granules/flakes tolerance of 0.30 ppm to ginseng 

without submitting any residue data on ginseng. The translation was approved by ChemSAC 

(ChemSAC minutes dated 09/ 11/13 and 09118/13. 

In addition, IR-4 requests removal of the established tolerances for the fo llowing commodities 

upon establishment of the crop subgroup tolerances: grape (3.0 ppm), tomato (2.0 ppm), and 

potato (0.06 ppm). 

In conjunction with this petition, an amended label of the 75% water dispersible granule (WOO) 

formulation ofzoxamide (Gavel® 75DF Fungicide; EPA Reg. No. 10163-64 14) was submitted 

to add uses on ginseng and reflect the crop group expansion. Gavel 75 DF agricultural fungicide 

is a mixture of 8.3% zoxamide and 66. 7% mancozeb. Only zoxan1ide is evaluated in this 

assessment. The product is proposed for up to six foliar applications at 0.12-0.17 lbs 

ai/A/application for a total seasonal application rate of 0.96 lb ai/A, with a prcharvest interval 

(PHI) of 28 days. The proposed use pattern for ginseng is simi tar to the existing registered use for 

potato, except for the PHI ( 14 days for potato). 

Adequate metabolism studies on potatoes, grapes, cucumbers, and tomatoes are available. The 

residue of concern for tolerance setting and risk assessment is zoxa111ide for grapes, grape 

processed commodities, tomatoes, and cucumbers. The residue of concern for tolerance setting 

and risk assessment is zoxamide and its metabolites (RH-1 452 and RH-1455) in/on potatoes and 

processed potatoes. 

The proposed use on ginseng and the crop subgroup expansions of zoxamide do not alter the 

Agency's previous conclusion that there is no reasonable expectation of finite residues in 

ruminant and poultry commodities [Category 3 of§ 180.6(a)]. 

Adequate analytical methods are available for enforcing zoxamide tolerances and collecting data 

on residues in plant commodities. The analytical methods, gas chromatography with electron 

capture detection (GC/ECD) and GC with mass selective detection (GC/MSD) are available for 

tolerance enforcement for plant commodities as primary and confirmatory methods, respectively. 

Page 2of 13 
Zoxamide Summary of Analytical Chemistry and Residue Data DP#: 429154 

For the acid metabolites (RI-1-1452 and RH-1455), the GC/MSD is the primary method and the 

GC/ECD method is the confirmatory method. The methods have been adequately validated for 

the determination of residues of zoxamide in plant commodities. Adequate multi residue 

methods testing data have been submitted. The data indicate that the multiresidue methods are 

adequate for enforcement of tolerances for zoxamide only. 

For ginseng, the Analytical Chemistry Branch (ACB)/Biological and Economic Analysis 

Division (BEAD) has successfully developed an analytical method which can be used for 

enforcement purposes. The residues are quantified by high-performance liquid chromatography 

with tandem mass spectrometry (LC-MS/MS). The method has been adequately validated for the 

determination of residues of zoxamide and its metabolites. 

Adequate storage stability data are available to support storage conditions and interva ls for the 

registered crops and the proposed ginseng use. 

The residue definitions are harmonized for the U.S. and Canada. The U.S. and Canadian residue 

definitions include zoxamide for grapes and processed grapes and zoxamide and its metabolites 

(RH-1452 and RI-1-1455) for potatoes and processed potatoes. The Codex residue definition 

includes the parent zoxamide only for all crops, and is therefore not harmonized with the 

tolerance expression for certain U.S. commodities. 

The tolerance recommendation for Tomato subgroup 8-1 OA at 2.0 ppm is harmonized with a 

Canadian maximum residue limit (MRL) on tomatoes at 2 ppm and a Codex MRL on tomatoes 

at 2 ppm. A tolerance was proposed and recommended in or on Small vine climbing fruit, except 

fuzzy kiwifruit, subgroup l 3-07F at 5.0 ppm, in order to harmonize with an established Codex 

MRL on grape at 5 ppm. The increased U.S. tolerance recommendation on subgroup 13-07F at 

5.0 ppm results in a lack of harmonization with an established Canadian MRL on grape at 3.0 

ppm. The tolerance recommendation for tuberous and conn vegetable subgroup IC at 0.06 ppm 

is harmonized with a Canadian MRL established on potato at 0.06 ppm; however, the U.S. 

tolerance is not harmonized with a Codex MRL at 0.02 ppm. The underlying residue data and 

residue definition used to support the Subgroup 1 C tolerance supports a tolerance 

recommendation that is higher than the established Codex MRL on potato at 0.02 ppm. There 

are no Codex or Canadian MRLs for ginseng. An International Residue Limit Status sheet is 

attached (Attachment IT). 

Regulatory Recommendations and Residue Chemistry Deficiencies 

HED has examined the residue chemistry databases for zoxamide. Pending submission of a 

revised Section B, as well as the submittal of analytical reference standards as listed below, there 

are no issues that would preclude the establishment of the recommended tolerances. Specific 

tolerance recommendations arc listed below on Table 2.2.2. 

Page 3of 13 
Zoxamide Summary of Analytical Chemistry and Residue Data DP#: 429154 

Table 2.2.2 Tolerance Summar ~ for Z-Oxamide 

Proposed Recommended Correct Commodity Commodity Tolerance Tolerance (ppm) Definition/Comments (ppm) 

To be established under 40 CFR &180.567 (a) General. (I) 

Tomato subgroup 8-1 OA 2.0 2.0 Established tolerance for tomato 

should be removed from the 

40CFR and replaced by this 

subgroup tolerance. 

17ruit, small, vine climbing, except 5.0 5.0 Fruit, small vine climbing. except 

fuzzy kiwifruit, Subgroup I 3-07F fuzzy ki111ifruit, subgroup 13-07 F 

Established tolerance for grape 

should be removed from the 

40CFR and replaced by this 

subgroup tolerance. Increase 

tolerance to har111011i::.e 111ith 

Codex. 

To be established under 40 CFR & 180.567 (a) General. (2) 

Vegetable, tuberous and corm, 0.060 0.06 Vegetable, tuberous and com1, 

Subgroup IC subgroup IC 

Established tolerance for potato 

should be removed from the 

40Cl7R and replaced by this 

subgroup tolerance. 

Ginseng 0.3 0.30 Establish tolerance based on potato 

granules/flakes data 

A human health risk assessment is forthcoming. 

Note to PM: In conjunction with establishment of the above tolerances, the existing 

tolerances for grape, tomato, and potato need to be removed from 40 CFR §180.567(a) as 

indicated above. 

860. 1200 Directions for Use 

• The proposed use directions for Gavel® 75DF Fungicide (EPA Reg. No. I 0 163-641 4) 

should be revised to include only ginseng and Tomato subgroup 8- l OA. Reference to the 

following commodities should be removed, as the registrant has withdrawn these 

proposed registrations: Small vine climbing fruit, except fuzzy kiwifruit, subgroup l 3-

07F, except for the previously-registered use on grape; and Tuberous and corm vegetable 

subgroup l C, except for the previously-registered use on potato. 

860.1 650 Submittal of Analytical Reference Standards 

• The analytical reference standard for zoxamide metaboli tes (RH 1452 and RH 1455) and 

derivatives (RH 14739 1 and RH 147399) is expired or is available only in I gram 

(personal email with Teresa Cole, ACB, 1 1/l6/2015). The registrant is required to submit 

a reasonable amount of the ana lytical reference standard for the metabolites and 

derivati ves. 

Page 4of 13 
Zoxamide Summary of Analytical Chemistry and Residue Data DP#: 429 154 

Background 

The chemical names and structures of zoxamide and the acid metabolites RH-1 452 and RH-1455 

are presented in Table I. The physicochemical properties of the technical grade of zoxamide are 

presented in Table 2. 

Table I. Zoxamide Nomenclature. 

Chemical structure 

0 

Cl ~ 

I 

N Cl 

H 

~ 0 

Cl 

Common name Zoxamide 

Company experimental name RH-7281 

IUPAC name (RS)-3,5-dichloro-N-(3-chloro-1-ethyl-1-mcthyl-2-oxopropyl)-p-toluamide 

Molecular weight 336.64 g/mol 

CAS name 3.5-dichloro-.V-(3-chloro- l-cthyl-1-mcthyl-2-oxopropyl)-4-methylbenzamide 

CAS registry number I 56052-68-5 

End-use product (EP) Gavel® 75DF Fungicidc (EPA Reg. No. I 0163-64 14) (This product is a combination of 

zoxamide + mancozeb. Only loxamidc residues have been determined.) 

Chemical structure CO,H 

~ 

I # 

C' 

a 

~OH 

Common name Rll-1 41452 

Company experimental name RH-1-152 

Chemical name 3.5-dichloro-4-hydroxymethylbenzoic acid 

Molecular weight 22 1.04 g/mol 

CAS Name Not available 

Page 5of13 
Zoxarnide Summary of Analytical Chemistry and Residue Data DP#: 429 154 

Table 1. Zoxamidc Nomenclature. 

Chemical structure 

Cl 

HO 

\_o 

HO 

c I 

' 

0 Cl 

Common name Rll-141455 

Company experimental name Rll-1455 

Chemical name 2.6-dichlorobcnzene-1.4-dicarboxylic acid 

Molecular weight 235 .02 g/mol 

CAS Name Not available 

Table 2. Physicochemical Properties or Zoxamidc. 

Parameter Value Reference 

Melting point/range I S9.S - 160.S °C (98.8% purity) MRID 49067102 

pl I 6.9 al 24.3°C 

Density Relative Density 1.38 at 20 °C 

Water solubility (al 20°C) 0.68 1±0.017 mg/L 

Solvent solubility (at 20°C) Ethyl acetate: 20.0 g/L 

Acetone: SS. 7 g/L 

Xylene: 1.56 g/L 

n-Octanol: 6.49 g/L 

n-Heptanc: 0.038 g/L 

1.2-Dichloroethanc: 12.S g/L 

Vapor pressure (at 25, 35. and 45°C) < 1.3 x O·~ Pa 

Dissociution constant, pK. Not measurnble by spectrophotometry, 

titration or conductivity. Absorbance did not 

change in acidic. neutral. or basic conditions: 

Solubility was too low for titration: with 

decrease in concentration, no increase in 

reading was observed. 

Octanol/water partition coefficient. Log Kow 3.76 ± 0.04 at ambient temp 

Kow 

UV/visible absorption spectrum 212 nm. t = 46330 

860.1200 Directions for Use 

The proposed use directions for Gavel® 75DF Fungicide (EPA Reg. No. 10 163-641 4) should be 

revised to include onl y ginseng and Tomato subgroup 8- 1 OA. Refe rence to the following 

commodities should be removed, as the registrant has withdrawn these proposed registrations: 

Small vine climbing fruit, except fuzzy kiwifruit, subgroup 13-07F, except for the previouslyregistered use on grape; and Tuberous and corm vegetable subgroup l C, except for the 

previously-registered use on potato. 

Page 6of1 3 
Zoxamide Summary of Analytical Chemistry and Residue Data DP#: 429154 

860.1300 Nature of the Residue - Plants 

Residue Chemistry Memo DP# 237892, 1/10/2001, A. Acierto 

Residue Chemistry Memo DP#s 266 181 , 0268774, 4/02/200 I, A. Acierto 

Adequate metabolism studies on potatoes, grapes, cucumbers, and tomatoes are avail able. 

The HED's Metabolism Assessment Review Committee (MARC) determined that the residue of 

concern for tolerance setting and risk assessment is zoxamide 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 vegetables for tolerances and risk assessment is zoxarnide. 

The nature of the residue of zoxamide on ginseng is understood based on available metabolism 

studies. 

Conclusions. The nature of the residue is adequately defined for ginseng, the tomato subgroup 8-

1 OA, the fruit, small vine climbing, except fuzzy kiwifruit, subgroup I 3-07F; and the vegetable, 

tuberous and corm, subgroup IC. The residue of concern for the tolerance and for risk 

assessment is zoxamide, except for subgroup 1 C. The residue of concern for the vegetable, 

tuberous and corm, subgroup IC for the tolerance and risk assessment is zoxamide and its 

metabolites (RH- 1452 and RH- I 455). 

860.1300 Nature of the Residue - Livestock 

Residue Chemistry Memo DP# 0277097, 12/ 18/2000, A. Acierto 

Residue Chemistry Memo DP# 237892, 1/10/200 1, W. Wassell, A. Acierto 

Ruminants: 

An acceptable metabolism study on goats is available. The MARC did not determine the residue 

of concern in ruminants since HED has concluded that livestock tolerances are not needed at this 

time. 

HED has concluded that tolerances for secondary residues in milk and ruminant tissues are not 

required at this time and the uses can be considered category 3 of 40 CFR §I 80.6(a). It is not 

possible to determine with certainty whether finite residues will be incurred, but there is no 

reasonable expectation of finite residues in milk and ruminant tissues. 

Page 7 of 13 
Zoxamide Summary of Analytical Chemistry and Residue Data DP#: 429154 

Poultry: 

A poultry metabolism study has not been submitted. There are no poultry feed items associated 

with the registered/proposed uses of zoxamide. Therefore, a poultry metabolism study is not 

required. However, if any crops which have poultry feed items are added in the future, then a 

poultry metabolism study will be required. 

Conclusions. Residues are not expected to occur in livestock commodities from the registered 

and proposed uses. These uses fall under 40 CFR § I 80.6(a)(3). 

860.1340 Residue Analytical Methods 

Residue Chemistry Memo DP# 237892, I/ I 0/200 I, A. Acieno 

Residue Chemistry Memo DP#s 266 181 , D268774, 4/02/200 I, A. Acieno 

Plant commodity methods 

Enforcement method: A gas chromatography method using electron capture detection (GC/ECO) 

as the prima1y method and a GC with mass selective detection (GC/MSD) as the confirmatory 

method are available for tolerance enforcement for plant commodities. Adequate method 

validation, radiovalidation, and independent method validation have been submitted for the 

primary and confirmatory methods. For the two acid metabolites, RH-1452 and RH-1455, in/on 

potato tubers and potato processed fractions, the GC/MSO method is proposed as the primary 

method and the GC/ECO method as the confirmatory method. The GC/ECO and GC/MSD 

methods were validated by the ACB/BEAD. After validation by ACB, the enforcement methods 

were forwarded to FDA (DP# 0 284394, 0 284396, 0284398, and 028400). 

For ginseng, the ACB have successfully developed an analytical method which can be used for 

enforcement purposes. The residues are quantified by high-performance liquid chromatography 

with tandem mass spectrometry (LC-MS/MS). The method has been adequately validated for the 

determination of residues of zoxamide and its metabolites. 

Livestock commodity methods 

HED has concluded that, based on the registered uses, residue analytical methods for animal 

commodities are not required for this petition. 

Conclusions. The residue analytical methods for plants are adequate. Acceptable methods are 

available for tolerance enforcement purposes for the residues of concern inion plant 

commodities. 

860.1360 Multi rcsidue Methods 

Residue Chemistry Memo DP# 237892, 1110/200 1, A. Acierto 

The petitioner has previously submitted data pertaining to the multiresidue methods testing of 

zoxamide and its metabolites (RH-1452 and RH-1455) in conjunction with PP#9F05058. The 

multiresidue methods data indicate that zoxamide was successfully recovered using Protocols 0 

and E, while none of the protocols successfully recovered either of the metabolites. The MRMs 

are adequate for enforcement of zoxamide tolerances. The submission has been forwarded to 

Page 8of13 
Zoxamide Summary of Analytical Chemistry and Residue Data DP#: 429154 

FDA for complete evaluation in conjunction with the earlier petition (0255783, N. Dodd, 

7/20/99). 

860.1380 Storage Stability 

Residue Chemistry Memo DP# 237892, 1/10/2001, A. Acieno 

Residue Chemistry Memo DP#s 266 181, D268774, 4/02/200 I, A. Acierto 

Based upon available data, residues of zoxamide in/on potatoes are stable during frozen storage 

for a period of 11.3 months. Based on the results of a successful radiovalidation study, residues 

of the acid metabolites in/on potato tubers are stable under frozen storage conditions for up to 29 

months. Potato crop field trial samples were stored frozen for a period of 12 to 23 months prior 

to analysis and potato processed commodities were stored frozen for a period of 12 months prior 

to analysis. Previously, adjustment of the potato processing data for storage degradation prior to 

analysis was not required. 

Conclusions. The avail able storage stability data for zoxamide on potatoes are adequate to 

support the storage durations and conditions of samples of ginseng. 

860.1400 Water, Fish, and Irrigated Crops 

This guideline requirement is nor relevant to the current petitions as there are no aquatic uses 

currently proposed for zoxamide. 

860.1460 Food Handling 

This guideline requirement is not relevant to the current petitions as there are no food handling 

uses being proposed for zoxamide. 

860.1480 Meat, Milk, Poultry, and Eggs 

There are no animal feed items associated with the new use inion ginseng. The proposed use and 

the crop subgroup expansions of zoxamide addressed in this document do not alter the Agency's 

previous conclusion that there is no reasonable expectation of finite residues in ruminant and 

poultry commodities [Category 3 of§ I 80.6(a)]. 

860.1500 Crop Field Trials 

Residue Chemistry Memo DP# 237892, 1/ 10/2001, A. Acieno 

Residue Chemistry Memo DPlls 266181, 0 268774, 4/02/200 I, A. Acierto 

Crop subgroup expansions 

No new crop field trial data were submitted or are required. The residue data used to support 

established tolerances on the representative commodities are adequate and may be used to 

support the tolerances on the crop subgroup conversions. All new crops added by the crop 

subgroup expansions will be treated at the same rate and timing as the currently registered crops. 

Ginseng 

A tolerance currently exists for zoxamide in/on potato granules/flakes at 0.30 ppm (40 CFR 

180.567). The proposed use pattern for ginseng is similar to the existing registered use for 

Page 9of13 
Zoxamide Summary of Analytical Chemistry and Residue Data 

potato, except for the PHI ( 14-days for potato). In addition, the nature of the potato 

(granules/flakes) and ginseng are similar: both are dried, starchy, and root crops. 

DPt/: 429 154 

Furthermore, residues in ginseng are expected lo be lower than residues in potatoes since ginseng 

has a higher PHI and lower moisture content. The proposal for translating the potato 

granules/flakes tolerance of 0.30 ppm to ginseng was approved by the ChemSAC (09/20 13). 

Per lR-4's request, the ACB have successfully developed an analytical method which can be used 

for enforcement purposes for the analysis of zoxamide and its metabolites in/on ginseng. The 

method was adequately validated on ginseng. 

Conclusions. Adequate field trial data are available to support the proposed crop subgroups and 

ginseng registrations. 

860.1520 Processed Food and Feed 

Processing studies for the cun-ently registered zoxamide uses are adequate. No processed food or 

feed is associated with the requested new use on ginseng. Zoxamide processing studies are 

available for potatoes and grapes. Tolerances are established on potato wet peel, potato flakes 

and raisins. 

860.1650 Submittal of Analytical Reference Standards 

Analytical standard for zoxan1ide is currently available in the EPA National Pesticide Standards 

Repository; with expiration date of 11/30/2019. However, the standards for zoxamide 

metabolites (RHl452 and RH l455) and derivatives (Rl-1147391 and Rl-1147399) expired and/or 

available only I gram (personal email with Teresa Cole, ACB, l l/ 16/2015). The registrant is 

required to submit a reasonable amount of the analytical reference standard for the metabolites 

and deri vatives. The reference standard should be sent to the Analytical Chemistry Lab, which is 

located at Fort Meade, Maryland, to the attention of either Theresa Cole or Thuy Nguyen at the 

following address: 

USEPA 

National Pesticide Standards Repository/ Analytical Chemistry Branch/OPP 

70 I Mapes Road 

Fort George G. Meade, MD 20755-5350 

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

860.1850 Confined Accumulation in Rotational Crops 

Residue Chemistry Memo DP# 237892. 1/10/200 I, A. Acierto 

Residue Chemistry Memo DP#s 266181, 0268774, 4/02/200 13, A. Acierto 

Acceptable confined rotational crop studies were reviewed in conjunction with PP#9F05058 on 

representative crops of mustard greens (leafy vegetable), radishes and turnips (root vegetables), 

sorghum and wheat (cereal grains) and soybeans (legume/oil seed). 

The parent compound was not identified in any rotational crop commodity at any plantback 

interval. The metabolite RH-1452 was tentatively identified at <1-7% of TRR (N0-0.0 11 ppm) 

Page 10 of1 3 
Zoxamide Summary of Analytical Chemistry and Residue Data DP#: 429154 

except in 30-day PBJ soybean forage where it accounted for 25% ofTRR (0.023 ppm). Based on 

the results of the reviewed confined rotational crop study, it was concluded that there is no 

indication that zoxamide would be detected in rotational crops planted more than 30 days after 

the application of zoxamide. 

Conclusion. The 30-day plant-back interval (PBf) specified on the label for rotated crops without 

primary uses of zoxamide is adequate. 

860.1900 Field Accumulation in Rotational Crops 

Residue Chemistry Memo OP# 237892, I/I 0/200 I, A. Acierto 

Residue Chemistry Memo DP#s 266181 , 0 268774, 4/02/200 I, A. Acierto 

Based on the results of the reviewed confined rotational crop study and the data requirements 

specified in OPPTS 860.1850, field accumulation studies are not required. 

860.1550 Proposed Tolerances 

Tolerances for residues of zoxamide have been established under 40 CFR § l 80.567(a)( 1) on 

grape at 3.0 ppm, grape, raisin at 15.0 ppm; tomato at 2.0 ppm, and vegetable, cucurbit, group 9 

at 1.0 ppm. Tolerances are established under 40 CFR § l 80.567(a)(2) for the combined residues 

of zoxamide and its metabolites RH-1452 and RH-1455 on onion, bulb, subgroup 3-07A at 0.7 

ppm; potato at 0.060 ppm; potato, granules/flakes at 0.30 ppm; and potato, wet peel at 0. 10 ppm. 

Table 3. Tolerance Summa ry for Zoxamide 

Proposed Recommended Correct Commodity Commodity Tolerance 

(ppm) Tolerance (ppm) Definition/Comments 

To be established under -tO CFR 80.567 (a) General. ( I) 

Tomato subgroup 8-1 OA 2.0 2.0 Established tolerance for tomato 

should be removed from the 

40CFR and replaced by this 

subgroup tolerance. 

Fruit, small, vine climbing, except 3.0 5.0 Fruit, small vine climbing, except 

fuzzy kiwifruit. Subgroup I 3-07F fu:zy kiwifruit, subgroup 13-07 F 

Established tolerance for grape 

should be removed from the 

40CFR and replaced by this 

subgroup tolerance. 

To be established under 40 CFR &180.567 (a) Genera l. (2) 

Vegetable, tuberous and corm, 0.06 0.06 Vegetable, tuberous and corm, 

Subgroup IC subgroup IC 

Established tolerance for tomato 

should be removed from the 

40CFR and replaced by this 

subgroup tolerance. 

Ginseng 0.3 0.30 Based om potato granules/flakes 

Page 11 of 13 
Zoxamide 

References 

DP#: 

Subject: 

From: 

To: 

Dated: 

DP#s: 

Subject: 

From: 

To: 

Dated: 

DP#s: 

Subject: 

From: 

To: 

Dated: 

MRJDs: 

DP#: 

Subject: 

From: 

To: 

Dated: 

MRJDs: 

Attachments: 

Summary of Analytical Chemistry and Residue Data DP#: 429154 

277097 

PP#9F05058; Zoxamide in/on Potato and Grapes. Conclusions of the l l/14/2000 

Meeting of the Metabolism Assessment Review Committee. 

A. Acierto 

G. Kramer 

12/ 18/2000 

237892 

PP#9F05058. Zoxamide in/on Grapes and Potatoes. Review of Analytical 

Methods and Residue Data. First Food Use Review. 

A. Acierto 

Rose Kearns/Cynthia Giles-Parker 

11101200 I 

266181 and 268774 

PP#OF06093. Zoxamide in/onTomatoes and Cucurbits. Review of Analytical 

Methods and Residue Data. 

A. Acierto 

Rose Kearns/Cynthia Giles-Parker 

4/2/200 1 

45012103to 45012118 

276323 

PP# 9F05058. IO# 000707-00271 & ID# 000707-00272: Zoxamide in/on Grapes 

and Potatoes. 

A. Acie110 

Rose Kearns/Cynthia Giles-Parker 

511012003 

45437802, 45499801 ,45461402, and4546I403 

International Residue Limit Status sheet 

Appendix I - Tolerance Assessment Calculations 

Template Version April 2008 

Page 12of 13 
Zoxamide Summary of Analytical Chemistry and Residue Data DP#: 429154 

International Residue Limits 

Zoxamide (PC Code 101702) 

Summary of US and International Tolerances and Maximum Residue Limits 

Residue De/ini1ion: 

us Canada Mexico2 Codex 

40 CFR 180. 567 (a)General Grapes and raisins: 3,5-dichloro- Zoxamide 

N-(3-chloro- I -cthyl-1-methyl-2-

(I) 3 ,5-d ichloro-N-(3-chloro-1-cthyl- I- oxopropyl)-4-methylbenzamicle 

methyl-2-

oxopropyl)-4-methylbenzamide Potatoes, potato processed 

(2) combined residues of zoxamide and fractions (chips, flakes and 

its metabolites 3.5-dichloro- 1,4- granules): 

benzenedicarboxylic acid (RH- 1455 and 3,5-dichloro-N-(3-chloro- 1-ethylRH-1 4 1455) and 3,5-dichloro-4- I -methyl-2-

hydroxymethylbenzoic acid (RH- 1452 oxopropyl)-4-methylbenzamide, 

and RH-141452) including the 

metabolites 3,5-dichloro-1 ,4-

benzcnc-dicarboxyl ic 

acid and 3,5-dichloro-4-

hydroxymethyl 

benzoic acid 

Commodity' Tolerance (00111) /Maximum Residue Limit (mf!/ kf!) 

us Canada Mexico2 Codex 

Ginseng 0.30 0.3 potato flakes/granules 

Tomato subgroup 8-1 OA 2.0 2 tomatoes 2 

tomatoes 

Fruit, small, vine climbing, 5.0 3 grapes 5 grapes 

except fuzzy kiwifruit, subgroup 

13-07F 

Vegetable, tuberous and comi, 0.06 0.06 potatoes 0.02 

subgroup 1 C potato 

Completed: M. Negussie; 09/ 17/15 

1 Includes only commodities of interest for this action. Tolerance values shou ld be the HED recommendations and 

not those proposed by the applicant. 

2 Mexico adopts US tolerances and/or Codex MRLs for its expon purposes. 

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