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REPORT TITLE

Tolerance Petition For Zoxamide On Dry Bulb Onions

DATA REQUIREMENTS

Not Applicable

AUTHOR

Karina Flores

COMPLETION DATE

July 22, 2013

PERFORMING LABORATORY

Not Applicable

SPONSOR

Gowan Company

P.O. Box 5569

Yuma, AZ 85366

PROJECT IDENTIFICATION

KRF20131

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TABLE OF CONTENTS

Page Subject

1 Title Page

2 Statement of No Data Confidentiality Claims

3 Good Laboratory Practice Compliance Statement

4 Table of Contents

5 Introduction

5 Informative Summary Statement

6 Section A: Identity of the Pesticide Chemical

7 Section B: Information on the Label to Be Marketed

8 Section C: Safety of Pesticide Chemical

10 Section D: Analytical Method and Proposed Tolerances

11 Section E: Practical Methods for Removing Residues That Exceed Any

Proposed Tolerance

11 Section F: Proposed Tolerances for the Pesticide Chemical

12 Section G: Reasonable Grounds In Support Of the Petition

14 Appendix I: Notice of Filing

20 Appendix II: Gavel 75DF Label

Volume II of II: Study

Magnitude of the Residue of Zoxamide and its Metabolites in or on Dry

Bulb Onion Raw Agricultural Commodities Following Eight Foliar

Applications of Gavel® 75DF- 2011 (Report No. TCI-11-319).

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TOLERANCE PETITION FOR ZOXAMIDE ON DRY BULB ONIONS

Introduction

Zoxamide is the common name of the active ingredient found in Zoxamide Technical (EPA Reg.

No. 10163-6415), Gavel 75DF (a mixture of zoxamide and mancozeb, EPA Reg. No. 10163- 6414) and Zoxium 80 W Agricultural Fungicide (EPA Reg. No. 10163-6413). This molecule

was discovered and developed for commercial production by Rohm and Haas and launched in

2001 prior to its divestiture to Dow AgroSciences, LLC; Dow purchased Zoxamide in July of

2001. In 2008, Margarita International (also known as Gowan Company) purchased the

worldwide zoxamide business from Dow AgroSciences. With this acquisition, licensed

commercial rights and regulatory responsibility were granted to Gowan Company.

Gowan Company seeks to establish a tolerance for the sum of zoxamide (3, 5-dichloro-N-(3- chloro-1-ethyl-1-methyl-2-oxopropyl)-4-methylbenzamide) and its metabolites 3,5-dichloro-1,4- benzenedicarboxylic acid (RH-1455 and RH-141455) and 3,5-dichloro-4-hydroxymethylbenzoic

acid (RH-1452 and RH-141452) calculated as the stoichiometric equivalent of zoxamide in or on

dry bulb onions (Crop Group 3, Bulb Vegetables).

In support of this petition, twelve residue programs using Gavel 75DF were conducted in various

NAFTA Regions during the 2011 and 2012 growing seasons to fulfill a U.S. and Canadian

tolerance. Gavel 75DF is comprised of 66% mancozeb and 8.3% zoxamide. As the current

mancozeb tolerances published in 40 CFR §180.176 support dry bulb onions uses proposed by

this petition, only the sum of zoxamide and its metabolites calculated as the stoichiometric

equivalent of zoxamide are discussed.

CONTENTS OF THE TOLERANCE PETITION: FQPA REQUIREMENTS

The FQPA requires that a number of additional considerations be addressed in a tolerance

petition. The contents of this petition are presented according to the information required in 40

CFR 180.7.

Informative Summary

Pursuant to Federal Food Drug and Cosmetic Act (FFDCA) §408(d)(2)(A)(i)(I), Gowan

Company concurrently submits an informative summary of the petition, data, and arguments in

support of this document. An electronic copy of a draft Notice of Filing, formatted using EPA

Template No. P25 in Microsoft Word (.wpd), will be e-mailed to the EPA Registration Division

Product Manager and is also attached in Appendix I of this document.

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Section A: Identity of the Pesticide Chemical

ISO Common Name: Zoxamide (active ingredient in Gavel 75 DF)

IUPAC Name: (RS)-3,5-dichloro-N-(3-chloro-1-ethyl-1-methyl-2-oxopropyl)-ptoluamide

CAS Name: 3,5-Dichloro-N-(3-chloro-1-ethyl-1-methyl-1-oxopropyl)-4- methylbenzamide

CAS Registry No.: 156052-68-5

EPA Chemical Code: 101702

Synonyms: RH-117,281 and RH-7281

Structural Formula:

Molecular Formula: C14H16NO2Cl3

Molecular Weight: 336.65

Residue Definition: Per 40 CFR 180.567(a)(1) and the May 2009 Memorandum on the

“Interim Guidance on Tolerance Expressions”,

1) Tolerances are established for residues of the fungicide

zoxamide, including its metabolites and degradates, in or on

the commodities in the table below. Compliance with the

tolerance levels specified below is to be determined by

measuring only zoxamide (3, 5-dichloro-N-(3-chloro-1-ethyl- 1-methyl-2-oxopropyl)-4-methylbenzamide).

Commodity

Parts per million

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Grape 3.0

Grape, raisin 15.0

Tomato 2.0

Vegetable, cucurbit, group 9 1.0

2) Tolerances are established for residues of the fungicide

zoxamide, including its metabolites and degradates, in or on

the commodities in the table below. Compliance with the

tolerance levels specified below is to be determined by

measuring only the sum of zoxamide (3, 5-dichloro-N-(3- chloro-1-ethyl-1-methyl-2-oxopropyl)-4-methylbenzamide)

and its metabolites 3,5-dichloro-1,4-benzenedicarboxylic acid

(RH-1455 and RH-141455) and 3,5-dichloro-4- hydroxymethylbenzoic acid (RH-1452 and RH-141452)

calculated as the stoichiometric equivalent of zoxamide, in or

on the following commodities:

Commodity Parts per million

Potato 0.060

Potato, granules/flakes 0.30

Potato, wet peel 0.10

For the purpose of this petition, Gowan Company seeks to establish a tolerance for the sum of

zoxamide and its metabolites (RH-1455 and RH-141455; RH-1452 and 141452) calculated as the

stoichiometric equivalent of zoxamide in or on dry bulb onions.

Information required on the manufacturing process and chemical analysis of the active ingredient

zoxamide is found in MRID No. 44731802.

Information regarding the certified limits and the analytical methods to determine the

composition of Gavel 75DF is found in MRID No. 47393306.

Section B: Information on the Label to Be Marketed

The recommended amount, frequency, and timing of the application of this pesticide chemical as

proposed on the Gavel 75DF label which is concurrently submitted and found in Appendix II of

this document. The data supporting the recommended use patterns can be found within report “Magnitude of the Residue of Zoxamide and its Metabolites in or on Dry Bulb Onion Raw

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Agricultural Commodities Following Eight Foliar Applications of Gavel® 75DF Fungicide—

2011” which is also submitted concurrently with this petition in Volume II. Gowan Company proposes a rate of 1.5 to 2.0 lbs./A of Gavel 75DF per application (0.12-0.17

lbs. zoxamide) with a 7 day PHI not to exceed 8 applications or apply more than 16 lbs. of Gavel

(1.33 lbs. zoxamide per acre per season). The rate and timing proposed for Gavel 75DF is

consistent with the data used to support the existing tolerance for mancozeb on onions and the

data generated by the zoxamide bulb onion residue study submitted here. The PHIs for both

active ingredients in Gavel 75DF are 7 days; see Table 1 below.

Table 1: Proposed label rates for dry bulb onions- Gavel 75DF

Bulb Onion

Proposed Max Single

App. Rate1

lbs. AI/A

(PHI in days)

Max Single

App. Rate2

lbs. AI/A

(PHI in days)

Max Single App.

Rate tested3

lbs. AI/A

(PHI in days)

Max.

Seasonal

Application

Rate

lbs. AI/A

Gavel 75DF1 Rate: 1.5-2.0

lbs./A

PHI: 7 days

Mancozeb 1.33 (7) 2.4 (7) N/A 242 Zoxamide 0.166 (7) N/A 0.17 (7) 1.333

1 Gavel 75DF proposed label in Appendix II.

2 EPA Reregistration Eligibility Decision for Mancozeb (September 2005)

3 2013 “Magnitude of the Residue of Zoxamide and its Metabolites in or on Dry Bulb Onion Raw

Agricultural Commodities Following Eight Foliar Applications of Gavel® 75DF Fungicide—2011”

Section C: Safety of Pesticide Chemical

In 2004, the Agency evaluated the available toxicity data and the information concerning the

variability of the sensitivities of major identifiable subgroups of consumers. An endpoint for

acute dietary exposures was not identified since no effects were observed in oral toxicity studies

that could be attributable to a single dose; therefore, acute dietary risk assessments were not

performed (Federal Register 69:16800 (March 31, 2004)). PRZM/EXAMS and SCI-GROW models illustrate that the EECs of zoxamide for chronic

exposures are estimated to be 21.8 parts per billion (ppb) for surface water and 2.1 ppb for

ground water. Zoxamide is not registered for use on any sites that would result in residential

exposure. Therefore, short-term and intermediate term aggregate risks were not assessed.

Zoxamide has been classified as not likely to be carcinogenic to humans. Therefore, the only

exposure scenario the Agency assessed is for chronic (non-cancer) exposures to zoxamide

(Federal Register 69:16800 (March 31, 2004)).

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A two year generation reproductive toxicity study on rats (MRID No. 44770001) was completed

in 1998. The study indicated that continuous exposure of rats to zoxamide technical in the diet

had a No Observed Adverse Effect Level (NOAEL) for parental animal toxicity of 5,000 ppm

(360-489 mg/kg/day in males; 409-534 mg/kg/day in females).

In addition, a rat and rabbit developmental studies (MRID Nos. 44731823 and 44731824) were

submitted and reviewed by the Agency. When zoxamide technical was administered to pregnant

rats, the No Observed Effect Level (NOEL) of 1000 mg A.I./kg/day (limit dose) was achieved.

Zoxamide is not maternally toxic, embryo-feto toxic or teratogenic at doses up to and including

1,000 mg A.I./kg/day (limit dose). When administered orally by gavage to pregnant rabbits, the

NOEL for maternal toxicity greater than or equal to 1,000 mg AI/kg. There were no

developmental toxicity or teratogenicity observed at any dose level.

For chronic dietary exposures, the chronic reference dose (cRfD) is 0.48

milligrams/kilogram/day(mg/kg/day). The FQPA safety factor was removed for zoxamide

because there is no indication of quantitative or qualitative increased susceptibility of rats or

rabbits to in utero and/or postnatal exposure; a developmental neurotoxicity study conducted

with zoxamide is not required. Therefore, the chronic population adjusted dose (cPAD) is 0.48

mg/kg/day (Federal Register 69:16800 (March 31, 2004)).

A Tier 1 Dietary Risk Assessment using the Dietary Exposure Evaluation Model-Food

Commodity Intake Database (DEEM-FCID) (Version 3.12) was used for determining the

potential aggregate exposure from food under existing and proposed tolerances for zoxamide

(Table 2). The model was performed assuming 100% crop treated. The DEEM indicates that

with the addition of bulb onions, the exposure utilizes 4.6% of the Chronic Population Adjusted

Dose (cPAD) for the most sensitive population or children ages 1-2 years old; previous cPAD

was 4% for children 1-6 years old in 2004. Exposure for the U.S. population is 1.4% of the

cPAD. The cPAD is not significantly affected due to the addition of bulb onions to the zoxamide

tolerance. Table 2: DEEM-FCID Chronic analysis for Zoxamide

Douglas G. Baugher Ver. 3.12, 03-08-d

DEEM-FCID Chronic analysis for ZOXAMIDE NHANES 2003-2008 2-day

Residue file name: C:\Program Files\CalendexWWEIAFCID\Zoxamide.r08

Adjustment factor #2 NOT used.

Analysis Date 02-14-2013/19:41:29 Residue file dated: 02-14-2013/19:40:44

Reference dose (RfD, Chronic) = .48 mg/kg bw/day

NOEL (Chronic) = 48 mg/kg bw/day

COMMENT 1: Chronic Dog Noel. No 10X FQPA factor.

===============================================================================

Total exposure by population subgroup

-------------------------------------------------------------------------------

Total Exposure

-----------------------------------

Population mg/kg Margin of Percent

Subgroup body wt/day Exposure of RfD

-------------------------------------- ------------- ---------- ----------

Total US Population 0.006584 7,291 1.4%

Hispanic 0.006916 6,941 1.4%

Non-Hisp-White 0.006668 7,198 1.4%

Non-Hisp-Black 0.005864 8,186 1.2%

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Non-Hisp-Other 0.006295 7,625 1.3%

Nursing Infants 0.003744 12,822 0.8%

Non-Nursing Infants 0.010483 4,579 2.2%

Female 13+ PREG 0.005576 8,608 1.2%

Children 1-6 0.018655 2,573 3.9%

Children 7-12 0.008250 5,818 1.7%

Male 13-19 0.005031 9,540 1.0%

Female 13-19/NP 0.004628 10,371 1.0%

Male 20+ 0.005156 9,310 1.1%

Female 20+/NP 0.005274 9,102 1.1%

Seniors 55+ 0.005182 9,264 1.1%

All Infants 0.008402 5,713 1.8%

Female 13-50 0.005162 9,298 1.1%

Children 1-2 0.022298 2,153 4.6%

Children 3-5 0.017497 2,743 3.6%

Children 6-12 0.009136 5,254 1.9%

Youth 13-19 0.004829 9,941 1.0%

Adults 20-49 0.005301 9,055 1.1%

Adults 50-99 0.005119 9,377 1.1%

Female 13-49 0.005184 9,259 1.1%

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Section D: Analytical Method and Proposed Tolerances

The analytical method and the investigations made with respect to the nature and amount of

zoxamide residues and its metabolites likely to remain in or on bulb onions is submitted

concurrently with this tolerance petition; refer to Volume II. The limit of quantitation (LOQ) in this study was 0.02 ppm and was the lowest level at which

control samples were fortified. The limit of detection (LOD) was defined as approximately 1/3

the LOQ or 0.007 ppm. No residues of zoxamide, RH-1452, and RH-1455 greater than the LOQ

were found in any untreated control with the exception of sample TCI-11-319-02-01 where RH- 1452 was found at 0.0203 ppm. The residues in the treated samples of dry bulb onions collected

at normal crop maturity 7 days after last application (DALA) are summarized below in Table 3:

Table 3: Magnitude of the Residue-Raw Agricultural Commodity

Magnitude of the Residue-Raw Agricultural Commodity

Range of Residues (ppm)a Matrix Zoxamide RH-1452b RH-1455b Total

Residuec Dry Bulb Onion <0.02 - 0.443 ND - 0.0529 ND 0.0391 - 0.443

a<0.02 ppm represents values <LOQ

bReported as parent (zoxamide) equivalent cFor residues <LOQ, calculated values were used for total residue calculations.

The method of analysis was validated on dry bulb onions before the treated trial samples were

analyzed. Validation for zoxamide, RH-1452, and RH-1455 for dry bulb onions consisted of

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analyzing two untreated control samples, three untreated control samples fortified at the limit of

quantification (LOQ) per analyte, and three untreated control samples fortified at 10× the LOQ

per analyte.

Section E: Practical Methods for Removing Residues That Exceed Any Proposed

Tolerance

The tolerance levels associated with these proposed uses are adequate to accommodate the

residue levels encountered. It will not be necessary to remove or reduce zoxamide residues from

treated commodities. There are no known methods for removing residues.

Section F: Proposed Tolerances for the Pesticide Chemical

In support of this petition, a residue program was conducted to determine the magnitude of

residues for zoxamide and its two acid metabolites, RH-1452 and RH-1455, in or on bulb onion

(Crop Group 3, Bulb Vegetables) raw agricultural commodities. Eight foliar broadcast

applications of Gavel 75DF Fungicide at the maximum proposed label use rate of 0.166 lb ai/A

zoxamide (0.186 kg ai/ha) with 7-day retreatment intervals and a 7-day preharvest interval (PHI)

were utilized. A total of twelve dry bulb onion trials were conducted in NAFTA Regions 1 (NY,

one trial), 5 (ON, two trials; MI, WI, and IA, one trial each), 6 (TX, one trial), 8 (KS, one trial),

10 (CA, two trials), 11 (ID, one trial), and 12 (OR, one trial) during the 2011 and 2012 growing

seasons. The number and geographic locations of field trials are adequate to support a U.S. and

Canadian tolerance. The results from these trials showed that after eight applications of Gavel® 75DF Fungicide at

the proposed rate, zoxamide residues ranged from <0.02 ppm (0.0159) to 0.443 ppm (mean =

0.163 ppm ± 0.115) on 24 bulb onion RAC samples collected 6-7 DALA. Residues of RH-1455

as parent equivalents were <0.007 on all 24 bulb onion RAC samples. Residues of RH-1452 as

parent equivalents ranged from <0.007 to 0.0529 ppm (mean = 0.0251 ppm ± 0.0132) on 24 bulb

onion RAC samples. Total residues (parent plus metabolites) ranged from 0.0391 to 0.443 ppm

(mean = 0.188 ppm ± 0.110) on 24 bulb onion RAC samples. For the decline trial TCI-11-319-04, mean zoxamide residues were 0.333, 0.339, 0.264, 0.293

and 0.167 ppm at 0, 3, 7, 10, and 14 DALA indicating an overall decline in residues over the 14

day sampling period. Mean RH-1452 residues as parent equivalents were 0.0266, 0.0309,

0.0263, 0.0230, and 0.0266 ppm at 0, 3, 7, 10, and 14 DALA indicating that residues were fairly

stable over the 14 day sampling period. RH-1455 residues were <0.007 at each sampling event.

Mean total zoxamide residues were 0.359, 0.370, 0.290, 0.316 and 0.194 ppm at 0, 3, 7, 10, and

14 DALA indicating an overall decline in residues over the 14 day sampling period. The halflives for zoxamide, RH-1452, and total zoxamide were 15.4, 81.5, and 17.0 days, respectively.

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Per OPPTS Guideline 860.100, neither a processing nor feeding study is required for this

commodity (Crop Group 3, Bulb Vegetables).

Gowan Company proposes to amend 40 CFR §180.567, zoxamide tolerances, to add the

following tolerance and commodity (Table 4):

Table 4: Proposed tolerance for zoxamide using NAFTA MRL Calculator Output

Commodity Proposed Tolerance/NAFTA MRL Calculator

Output in Parts Per Million (PPM)

PHI (days)

Onion, dry bulb 0.7 7

The OECD calculator was used as a tool to estimate the maximum residue limit. Compliance

with the tolerance levels is to be determined by measuring the sum of zoxamide (3, 5-dichloro- N-(3-chloro-1-ethyl-1-methyl-2-oxopropyl)-4-methylbenzamide) and its metabolites 3,5- dichloro-1,4-benzenedicarboxylic acid (RH-1455 and RH-141455) and 3,5-dichloro-4- hydroxymethylbenzoic acid (RH-1452 and RH-141452) calculated as the stoichiometric

equivalent of zoxamide, in or on dry bulb onions.

FFDCA Section 408(b)(4) requires EPA to consider the international maximum residue limits

established by the Codex Alimentarius Commission (Codex) in order to harmonize U.S.

tolerances with international standards wherever possible. Neither Codex Alimentarius, Canada

nor Mexico have established Maximum Residue Levels (MRLs) for zoxamide on bulb onions.

Therefore, no compatibility issues exist with regard to the proposed U.S. bulb onion tolerance.

Section G: Reasonable Grounds In Support Of the Petition

Detailed information regarding the adequacy of the analytical report with respect to the

sensitivity can be found in Volume II. No residues of zoxamide, RH-1452, and RH-1455 greater than the LOQ were found in any

untreated control with the exception of sample TCI-11-319-02-01, RH-1452 with a residue of

0.0203 ppm. Parent residues ranged from <0.02 ppm (0.0159) to 0.443 ppm while RH-1452 as

parent equivalents ranged from <0.007 to 0.0529 ppm on 24 bulb onion treated samples.

EPA has evaluated the available toxicity data and considered its validity, completeness, and

reliability as well as the relationship of the results of the studies to human risk (Federal Register

69:16800 (March 31, 2004)).

If used in accordance to the proposed label, adequate data is provided to support the proposed

tolerance for zoxamide on onions and the established tolerance for mancozeb on onions.

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There were no omissions or substitutions of the required data or information as required per 40

CFR 180.7.

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APPENDIX I:

Notice of Filing

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i

EPA REGISTRATION DIVISION COMPANY NOTICE OF FILING FOR PESTICIDE

PETITIONS PUBLISHED IN THE FEDERAL REGISTER

EPA Registration Division contact: [insert name and telephone number with area code]

INSTRUCTIONS: Please utilize this outline in preparing the pesticide petition. In cases

where the outline element does not apply, please insert “NA-Remove” and maintain the

outline. Please do not change the margins, font, or format in your pesticide petition. Simply

replace the instructions that appear in green, i.e., “[insert company name],” with the

information specific to your action.

TEMPLATE:

[Gowan Company, LLC.]

[Petition number 3F8164]

EPA has received a pesticide petition ([Petition number 3F8164]) from [Gowan

Company], [P.O. Box 5569, Yuma, AZ 85366] proposing, pursuant to section 408(d) of the

Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a(d), to amend 40 CFR part 180.

(Options (pick one)

1. by establishing a tolerance for residues of

2. to establish an exemption from the requirement of a tolerance for

[The sum of zoxamide (3, 5-dichloro-N-(3-chloro-1-ethyl-1-methyl-2-oxopropyl)-4- methylbenzamide) and its metabolites 3,5-dichloro-1,4-benzenedicarboxylic acid (RH-1455

and RH-141455) and 3,5-dichloro-4-hydroxymethylbenzoic acid (RH-1452 and RH-141452)

calculated as the stoichiometric equivalent of zoxamide] in or on the raw agricultural

commodity [dry bulb onions (Crop Group 3, Bulb Vegetables)] at [0.7] parts per million

(ppm). EPA has determined that the petition contains data or information regarding the elements

set forth in section 408 (d)(2) of FDDCA; however, EPA has not fully evaluated the sufficiency

of the submitted data at this time or whether the data supports granting of the petition. Additional

data may be needed before EPA rules on the petition.

A. Residue Chemistry

1. Plant metabolism. [A plant metabolism study was not conducted on bulb onions; a

metabolism study performed on potatoes, which analyzed for zoxamide and its metabolites,

is referenced due to the nature of the crops.

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The total radioactive residues recovered in the potato residue study were 0.178 ppm

(MRID No. 44731901). Analysis of the TRR by extraction and chromatography failed to

show any RH-117281 residues. There were two predominant metabolites identified, RH- 141452 and RH-141455, accounting for up to 60.1% of the total TRR (0.107 ppm as parent

equivalents). The route of formation of the potato residues is probably via uptake of highly

degraded material from soil, rather than by absorption and reaction of the parent

compound from foliar exposure. No parent or closely related whole molecule oxidation

products from the parent were found.

2. Analytical method. [An analytical method used to quantitate the residues of

zoxamide and its metabolites, RH-1452 and RH-1455, in bulb onion RAC samples (MRID

45138102) was performed using gas-liquid chromatography and mass selective (MSD)

detection.

Residues of parent zoxamide, RH-1452, and RH-1455 were extracted from

subsamples of dry bulb onion with solvent using a mixer equipped with homogenizer

probe. The extracts were vacuum filtered, evaporated to the aqueous phase, and subjected

to a liquid-liquid partition separating zoxamide from it two metabolites (RH-1452 and RH- 1455). The extract containing zoxamide was purified with a solid phase extraction (SPE)

and B-SPE clean-up. The purified extract was evaporated and brought to a final volume

with solvent and submitted to GC for analysis. The extract containing RH-1452 and RH- 1455 was acidified, partitioned into ethyl acetate, and then methylated to the respective

methyl esters (RH-7391 and RH-7399). The methylated extract was further purified,

evaporated to dryness, and submitted to GC for analysis.

The limit of quantitation (LOQ) in this study was 0.02 ppm and was the lowest level

at which control samples were fortified. The limit of detection (LOD) was defined as

approximately 1/3 the LOQ or 0.007 ppm.]

3. Magnitude of residues. [The bulb onion residue study proves that there will be no

quantifiable zoxamide, 3,5-dichloro-1,4-benzenedicarboxylic acid (RH-141455) metabolite,

and 3,5-dichloro-4-hydroxymethylbenzoic acid (RH-141452) metabolite residues found in

the raw agricultural commodity above the proposed tolerance of 0.7 ppm at the proposed

rates and application of Gavel 75DF.]

B. Toxicological Profile

1. Acute toxicity. [Acute studies have been evaluated by the Agency and

considered valid and complete. The acute oral study (MRID No. 44731806) in both rat and

mouse produced an LD50 of >5,000 m/kg (males and females combined). A dermal study

(MRID No. 44731807) in rats resulted in a toxicity category III with an LD50 > 2,000 mg/kg

(males and females combined) while an inhalation study produced an LC50 > 5.3 mg/L

(MRID No. 44731808). A primary eye irritation study was performed on rabbits and

resulted as a moderate irritant (MRID No. 44731809); a primary skin irritation study

proved not to be an irritant (MRID No. 44731809). Two sensitization studies conducted

using both maximization and Buehler methods were performed according to guideline

870.2600. The maximization test proved to be a skin sensitizer (MRID No. 44731811);

Buehler method on guinea pigs also produced delayed hypersensitivity at all concentrations

tested (MRID No. 44731812).

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Acute dietary risk assessments were not performed as no acute dietary endpoint was

identified; no effects were observed in oral toxicity studies that could be attributable to a

single dose.]

2. Genotoxicty. [Zoxamide is not mutagenic in Ames assays, in Chinese Hamster

Ovary (CHO) cells assay at the Hypoxonthine guanine phosphoribosyle transferase

(HGPRT) locus, and in the mouse bone marrow micronucleus assay. Zoxamide did not

induce structural chromosome aberrations in cultured CHO cells treated up to the limit of

toxicity but did induce increased levels of numerical aberrations.]

3. Reproductive and developmental toxicity. [A two year generation reproductive

toxicity study on rats indicated that continuous exposure of rats to zoxamide technical in

the diet had a No Observed Adverse Effect Level (NOAEL) for parental animal toxicity of

5,000 ppm. The only effect seen at 20,000 ppm was a decrease in body weight gain and

feed consumption. No adverse reproductive or developmental effects were seen at doses up

to and including 20,000 ppm

Two developmental studies have been performed on rats and rabbits using an oral

gavage method. When zoxamide technical was administered to pregnant rats, the No

Observed Effect Level (NOEL) of 1000 mg A.I./kg/day (limit dose) was achieved.

Zoxamide is not maternally toxic, embryo-feto toxic or teratogenic at doses up to and

including 1,000 mg A.I./kg/day (limit dose). When administered orally by gavage to

pregnant rabbits, the NOEL for maternal toxicity was observed to be greater than or equal

to 1,000 mg AI/kg. There were no developmental toxicity or teratogenicity observed at any

dose level.]

4. Subchronic toxicity. [The NOAEL in a 90-day rat subchronic feeding and

neurotoxicity study was 1,500 mg/kg/day in males and 1,622 mg/kg/day in females HDT.

Zoxamide did not produce neurotoxic or neuropathologic effects.

A 90-day feeding study with mice, the NOAEL was 436 mg/kg/day in males and 574

mg/kg/day in females based on a slight decrease in weight gain among the females only at

the LOAEL of 1,666 mg/kg/day.

A 90-day dog feeding study gave a NOAEL of 55 mg/kg in males and 62 mg/kg/day in

females based on increased liver weights without a corresponding clinical or

histopathologic change in females only at 322 mg/kg/day.

No signs of systemic toxicity were observed when zoxamide was administered dermally

to rats for 28-30 days at a limit dose of 1,000 mg/kg/day). This occurred despite skin

irritation at all doses tested (150, 400, and 1,000 mg/kg/day). Similarly, in vivo dermal

absorption was shown to be low regardless of concentration or formulation type (i.e., 1-6%

of the administered dose was systemically absorbed after 24 hrs.)]

5. Chronic toxicity. [In a combined rat chronic/oncogenicity study, the NOAEL for

chronic toxicity was 51 mg/kg/day in males and 65 mg/kg/day in females based on an

equivocal increase in relative liver weight at a LOAEL of 328 mg/kg/day in females at the

interim sacrifice only. The NOAEL was considered to be 1,058 mg/kg/day in males and

1331 mg/kg/day in females (HDT, limit dose). No carcinogenicity was observed.

An 18-month mouse oncogenicity study (MRID No. 44731819) showed no signs of

carcinogenicity or of any other compound-related effect at dosage levels up to 1021

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mg/kg/day in males and 1,289 mg/kg/day in females (limit dose).

The NOAEL in a 1-year feeding study in dogs was 255 mg/kg/day in males and 48

mg/kg/day in females based on minimal effects on body weight and body weight gain and

increased liver weights in females only at a LOAEL of 278 mg/kg/day (MRID No.

44731817).]

6. Animal metabolism. [In pharmacokinetic and metabolism studies in the rat,

zoxamide was extensively absorbed following oral dosing, rapidly and extensively

metabolized to a large number of metabolites, and rapidly eliminated from the body. No

evidence of accumulation of the parent compound or its metabolites was observed).]

7. Metabolite toxicology. [The tolerances requested for dry bulb onions are for the

sum of zoxamide (3, 5-dichloro-N-(3-chloro-1-ethyl-1-methyl-2-oxopropyl)-4- methylbenzamide) and its metabolites 3,5-dichloro-1,4-benzenedicarboxylic acid (RH-1455

and RH-141455) and 3,5-dichloro-4-hydroxymethylbenzoic acid (RH-1452 and RH-141452)

calculated as the stoichiometric equivalent of zoxamide. Neither metabolite RH-141455 nor metabolite RH-141452 (MRID No. 44731835) is

mutagenic in a Salmonella gene mutation assay.]

8. Endocrine disruption. [Zoxamide is listed in the November 2012 U.S.

Environmental Protection Agency Endocrine Disruptor Screening Program Universe of

Chemicals.

Zoxamide is unlikely to exhibit endocrine activity based on structure-activity and

mode of action information as well as the lack of developmental and reproductive toxicity,.

There was no evidence of a functional or histopathologic change in the male or female

reproductive tract, and no indicators of an endocrine effect of any kind below limit doses in

mammalian subchronic or chronic studies or in mammalian and avian reproduction

studies. A slight thyroid effect at the limit dose (994-1139 mg/kg/day) in the subchronic

and chronic dog studies was secondary to liver hypertrophy and enlargement at that dose.

Collectively, the weight of evidence provides no indication of an endocrine effect of

zoxamide.]

C. Aggregate Exposure

1. Dietary exposure. [Tolerances are established for residues of the fungicide

zoxamide (3, 5-dichloro- N -(3-chloro-1-ethyl-1-methyl-2-oxopropyl)-4-methylbenzamide), including its metabolites and degradates, in or on grape (3.0 ppm), grape, raisin (15.0

ppm), tomato (2.0 ppm), and vegetable cucurbit (1.0 ppm). Tolerances are also established

for the combined residues of zoxamide and its metabolites (3,5-dichloro-1,4- benzenedicarboxylic acid and 3,5-dichloro-4-hydroxymethylbenzoic acid) in or on potatoes

(0.060 ppm), granules/flakes (0.30 ppm), and wet peel potatoes (0.10 ppm).

Gowan Company seeks to establish a tolerance for the sum of zoxamide and its

metabolites (RH-1455 and RH-141455; RH-1452 and 141452) calculated as the

stoichiometric equivalent of zoxamide in or on dry bulb onions at 0.7 ppm. Zoxamide

residue trials were conducted using Gavel 75DF, an end use product comprised of 66%

Mancozeb technical and 8.3% Zoxamide technical. Current mancozeb tolerances

published in 40 CFR §180.176 support bulb onions uses.]

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i. Food. [A Tier I DEEM-FCID (Dietary Exposure Evaluation Model – Food

Commodity Intake Database) Chronic analysis (Version 3.12) for zoxamide was completed

for purposes of assessing the potential aggregate exposure from food under existing and

proposed tolerances for zoxamide. The model was performed assuming 100% crop

treated.

An acute dietary risk assessment was not performed as no acute dietary endpoint

was identified.

A chronic dog NOEL of 48 mg/kg bw/day determined for zoxamide in a 1-year

toxicity study in dogs was used for the DEEM.]

ii. Drinking water. [PRZM/EXAMS and SCI-GROW models illustrate that the EECs

of zoxamide for chronic exposures are estimated to be 21.8 parts per billion (ppb) for

surface water and 2.1 ppb for ground water.]

2. Non-dietary exposure. [Zoxamide is not registered for residential uses; therefore,

residential exposure is not expected.]

D. Cumulative Effects

[EPA does not have available data to determine whether zoxamide has a common

mechanism of toxicity with other substances or how to include this pesticide in a

cumulative risk assessment. Zoxamide does not appear to produce a toxic metabolite

produced by other substances. For the purposes of this tolerance action, therefore, EPA

has not assumed that zoxamide has a common mechanism of toxicity with other

substances.]

E. Safety Determination

1. U.S. population. [Chronic dietary exposure to zoxamide from food (including bulb

onion) utilizes 1.4% of the cPAD (0.48 mg/kg/day) for the U.S. population. The chronic

(non-cancer) exposure to zoxamide is 0.48 mg/kg/day.]

2. Infants and children. [Chronic dietary exposure to zoxamide from food (including

bulb onions) utilizes 11.9% of the Chronic Population Adjusted Dose (cPAD) for infants

and children ages 1-12 years of age. The addition of bulb onions (Crop Group 3, Bulb

Vegetables) did not significantly affect the cPAD established in 2004 (4%) for children ages

1-2 as it only increased the percentage by 0.6% of the cPAD to 4.6%.]

F. International Tolerances

[Neither Codex Alimentarius, Canada nor Mexico have established Maximum

Residue Levels (MRLs) for zoxamide on bulb onions. Therefore, no compatibility issues

exist with regard to the proposed U.S. bulb onion tolerance.]

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APPENDIX II:

Gavel 75DF Label

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GROUP M 22 FUNGICIDE

GAVEL®75DF

Fungicide

AGRICULTURAL

READ THE LABEL AND BOOKLET BEFORE USING

KEEP OUT OF REACH OF CHILDREN

CAUTION

ACTIVE INGREDIENTS/GUARANTEE: % By Wt.

MANCOZEB: A coordination product of zinc ion and manganese ethylene bisdithiocarbamate.....66.7%

In which the ingredients are:

Manganese++....................................................................................13.3%

Zinc++..................................................................................1.7%

Ethylene bisdithiocarbamate ion (C4H6N2S4) ............................51.7%

ZOXAMIDE: 3, 5-Dichloro-N-(3-chloro-1-ethyl-1-methyl-2-oxopropyl)-4-methylbenzamide............8.3%

OTHER INGREDIENTS: ...............................................................................................25.0%

 TOTAL 100.0%

PRECAUTIONARY STATEMENTS

HAZARDS TO HUMANS AND DOMESTIC ANIMALS

CAUTION

Causes moderate eye irritation. Avoid contact with eyes or clothing. Wash thoroughly with soap and 

water after handling and before eating, drinking, chewing gum, using tobacco or using the toilet. 

Prolonged or frequent repeated skin contact may cause allergic reactions in some individuals. Harmful 

if inhaled. Avoid breathing dust. Remove contaminated clothing and wash clothing before reuse. This 

product is a dermal sensitizer. 

EPA Reg. No. 10163-6414

EPA Est. No. 003125-FRA-001

Gowan Company

P.O. Box 5569

Yuma, AZ 85366-5569 USA

Registration No. 26842 PEST CONTROL PRODUCTS ACT

Produced For/Fabriqué pour:

NoD’HOMOLOGATION 26842 LOI SUR

LES PRODUITS ANTIPARASITAIRES

NoD’HOMOLOGACION de I’EPA 10163-287

NAFTA-0909 (800) 883-1844 

IMPORTANT NOTICE

This product is registered in both the U.S. and Canada. It has BOTH U.S. and Canada Labeling.

You must follow ONLY the U.S. label WHEN USING THIS product in the U.S.

You must follow ONLY the Canadian label WHEN USING THIS product in Canada.

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FIRST AID

When seeking medical attention take the container label if at all possible. If not, take the 

information which identifies the product, that is, the product name and registration numbers.

If swallowed  Call a poison control center or doctor immediately for treatment advice. 

 Have a person sip a glass of water if able to swallow. 

 Do not induce vomiting unless told to do so by a poison control center or doctor. 

Do not give anything by mouth to an unconscious person.

If on skin or 

clothing

 Take off contaminated clothing. 

 Rinse skin immediately with plenty of water for 15-20 minutes. 

 Call a poison control center or doctor for treatment advice.

If inhaled  Move person to fresh air. 

 If person is not breathing, call 911 or an ambulance, then give artificial respiration, 

preferably by mouth-to-mouth, if possible. 

 Call a poison control center or doctor for further treatment advice. 

If in eyes  Hold eye open and rinse slowly and gently with water for 15-20 minutes. 

 Remove contact lenses, if present, after the first 5 minutes, then continue rinsing. 

 Call a poison control center or doctor for treatment advice.

HOT LINE NUMBER

In the U.S. In case of emergency endangering health or the environment involving this product

call 1-888-478-0798.

TOXICOLOGICAL INFORMATION

No specific antidote. Employ supportive care. Treatment should be based on judgment of the 

physician in response to reactions of the patient.

AGRICULTURAL CHEMICAL

Do not ship or store with food, feeds, drugs or clothing.

ENVIRONMENTAL HAZARDS

This pesticide is toxic to fish. Drift and runoff from treated areas may be hazardous to aquatic 

organisms in neighboring areas. For terrestrial uses, do not apply directly to water, to areas where 

surface water is present, or to intertidal areas below the mean high water mark. Do not contaminate 

water when disposing of wastes.

In Canada – Refer to label booklet for additional buffer zone information.

STORAGE

Keep away from fire and sparks. Store in a cool, dry, well-ventilated area. Do not allow to 

become wet or overheated in storage: decomposition, impaired activity, or fire may result. Keep 

container closed when not in use. Pallets of containers should not be stacked more than three 

high. Provide access aisle for each two rows. Decomposition produces a foul odor; if observed, 

check for hot containers and immediately remove to open areas for disposal.

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GROUP M 22 FUNGICIDE

GAVEL®75DF

Fongicide

AGRICOLE

LIRE L’ÉTIQUETTE ET LE LIVRET AVANT L’UTILISATION

GARDER HORS DE LA PORTÉE DES ENFANTS

ATTENTION

INGRÉDIENTS ACTIFS/GARANTIE:

MANCOZÉBE: Produit de coordination de l’ion zinc l’éthyléne bis (dithiocarbamate)..................66,7%

Consititué des ingredients suivants:

 Manganese++...........................................................................13,3%

 Zinc++.....................................................................................1,7%

 Ion zinc avec l’éthyléne bis (dithiocarbamate) (C4H6N2S4) ..............51,7%

ZOXAMIDE: 3,5 Dichloro-N-(3-chloro-1-ethyl-1- methyl-2-oxopropyl)-4-methyllbenzamide.............8,3%

INGRÉDIENTS AUTRES................................................................................................25,0%

 TOTAL 100,0%

PRÉCAUTIONS

DANGEREUX POUR LES HUMAINS ET LES ANIMAUX DOMESTIQUES.

ATTENTION

Cause une irritation modérée des yeux. Éviter tout contact avec la peau, les yeux ou les vêtements. 

Se laver à fond avec de l’eau et du savon après la manipulation du produit. Des contacts prolongés ou 

fréquemment répétés avec la peau peuvent causer des réactions allergiques chez certaines 

IN THE UNITED STATES

PPE and Disposal - Refer to label booklet for Personal Protective Equipment and Directions for 

Use and Disposal.

Agricultural Use Requirements - Use this product only in accordance with its labeling and with 

the Worker Protection Standard, 40CFR Part 170. Refer to supplemental labeling under 

“Agricultural Use Requirements,” in the Directions for Use section for information about this 

standard.

It is a violation of United States law to use this product without having obtained the United States 

label at the time of purchase and following the U.S. label at the time of application.

Notice: Read the entire label. Use only according to label directions. Before using this product, 

read “Warranty Disclaimer,” “Inherent Risks of Use,” and “Limitation of Remedies” at the 

end of label booklet. If terms are unacceptable, return at once unopened. 

IN CANADA

PPE and Disposal - Refer to label booklet for Personal Protective Equipment and Directions for 

Use and Disposal.

NOTICE TO USER: This pest control product is to be used only in accordance with the directions 

on the label. It is an offense under the Pest Control Products Act to use this product in a way that is 

inconsistent with the directions on the label. The user assumes the risk to persons or property that 

arises from any such use of this product.

AVIS IMPORTANT

Ce produit est homologué tant aux États-Unis qu’au Canada. Il comporte une étiquette TANT 

américaine QUE canadienne.

Vous devez suivre SEULEMENT l’étiquette américaine en UTILISANT CE produit aux États-Unis.

Vous devez suivre SEULEMENT l’étiquette canadienne en UTILISANT CE produit au Canada.

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personnes. Dangereux si inhalé. Éviter de respirer les poussières. Enlever les vêtements contaminés 

et les laver avant de les remettre. Ce produit est un sensibilisant de la peau.

PREMIERS SOINS

Lorsqu’on cherche á obtenir des soins médicaux, apporter l’étiquette du contenant avec soi si 

c’est possible. Sinon, noter l’information identifiant le produit, c.-à-d. le nom du produit et ses 

numéros d’homologation. 

En cas d’ingestion:  Appeler un centre anti-poison ou un médecin immédiatement pour obtenir 

des conseils sur le traitement. 

 Faire boire un verre d’eau à petites reçu si la personne empoisonnée est 

capable d’avaler. 

 Ne pas faire vomir à moins d’avoir recu le conseil de procéder ainsi par le 

centre anti-poison ou le médecin. Ne rien administrer par la bouche à une 

personne inconsciente. En cas de contact avec la peau ou les vêtements 

contaminés. Rincer immédiatement pour obtenir des conseils sur le 

traitement.

En cas de contact 

avec la peau our les:

 Enlever ou les vêtements contaminés. 

 Rincer immédiatement la peau à grande eau pendant 15 à 20 minutes. 

 Appeler un centre anti-poison ou un médecin immeédiatement pour obtenir 

des coneils sur le traitement.

En cas d’inhalation:  Déplacer la personne vers une source d’air frais. 

 Si la personne ne respire pas, appeler le 911 ou une ambulance, puis 

pratiquer la respiration artificielle, de préférence le bouche-à-bouche, se 

possible. 

 Appeler un centre anti-poison ou un médecin immédiatement pour obtenir 

des conseils sur le traitement.

En cas de contact 

avec les yeux: 

 Garder les paupières écartées et rincer doucement et lentement avec de 

l’eau pendant 15 à 20 minutes. 

 Le cas échéant, retirer les lentilles cornéennes au bout de 5 minutes et 

continuer de rincer l’oeil. 

 Appeler un centre anti-poison ou un médecin immédiatement pour obtenir 

des conseils sur le traitement.

NUMÉRO D’INFORMATION

Aux États-Unis – En cas d’urgence menacant la santé ou l’evnironnement et mettant en cause ce 

produit, appeler au 1-888-478-0798.

RENSEIGNEMENTS TOXICOLOGIQUES

Aucun antidote spécifque. Donner des soins de soutien. Le traitement doit être basé sur le jugement 

du médecin en fonction des réactions du patient.

PRODUIT CHIMIQUE AGRICOLE

Ne pas entreposer ni expéditer prés des aliments pour les humains ou les animaux, des produits 

pharmaceutiques ou des vêtements.

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RISQUES POUR L’ENVIRONNEMENT

Ce pesticide est toxique pour les poissons. La dérive et le ruissellement provenant des zones traitées 

peuvent être dangereux pour les organismes aquatiques des zones voisines. Pour les usages au sol, 

ne pas appliquer directement dans l’eau, dans les endroits où il y a des eaux de surface, ou dans les 

zones intertidales situées sous la limite de marée haute moyenne. Ne pas contaminer l’eau en y 

éliminant les eaux de rincage de l’équipement ou en y éliminant des déchets.

Au Canada – Consulter le livret pour plus de renseignements sur les zones tampons.

AUX ÉTATS-UNIS

Équipment de protection individuelle et elimination – Consulter le livret pour des renseignements 

sur l’équipement de protection individuelle et le mode d’emploi, y compris l’élimination.

Exigences relatives à l’exploitation agricole – N’utiliser le produit que conformément à son étiquette 

et au Worker Protection Standard, 40CFR partie 170. Consulter le livret à « Exigences relatives à 

l’exploitation agricole » dans la section Mode d’emploi pour des renseignements sur cette norme.

Utiliser ce produit sans avoir obtenu l’étiquette américaine au moment de l’achat et sans avoir suivi 

l’éapplication constitue une infraction à la loi américaine.

Avis: Lire l’étiquette en entire. N’utiliser ce produit que conformément aux directives de l’étiquette. 

Avant d’utiliser ce produit, lire les sections <<Exonération de garantie>>, et <<Limitation des 

recours>> à la fin du livret. Si vous n’ëtes pas d’accord avec les conditions, retourner 

immédiatement le produit sans l’ouvrir.

AU CANADA

Équipement de protection individuelle et elimination – Consulter le livret pour des renseignements 

sur l’équipement de protection individuelle et le mode d’emploi, y compris l’élimination.

AVIS À L’UTILISATEUR: Ce produit antiparasitaire doit être employé strictement selon le mode 

d’emploi qui figure sur la présente etiquette. L’emploi non conforme à ce mode d’emploi constitue une 

infraction à la Loi sur les produits antiparasitaires. L”utilisateur assume les risques de blessures aux 

personnes ou de dommages aux biens que l’utilisation du produit peut entraîner.

Gavel®is a registered trademark used under license by Gowan Company, LLC.

Gavel est une marque de commerce sous license par Gowan Company, LLC.

ENTREPOSAGE

Tenir loin du feu et des étincelles. Entreposer dans un endroit frais, sec et bien ventilé. Éviter 

l’humidité et la surchauffe Durant l’entreposage qui peuvent causer la décomposition, la 

modification de l’activité ou un incendie. Garder le contenant fermé lorsqu’il n’est pas utilise. Ne 

pas empiler plus de 3 palettes de contenants. Laisser un couloir d’accés toutes les 2 rangées. La 

décomposition produit une mauvaise odeur. Le cas échéant, vérifier si des contenants sont 

chauds et les sortir immédiatement à l’air libre pour les éliminer.

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U.S. LABEL

GROUP M 22 FUNGICIDE

It is a violation of United States law to use this product in the United States in a manner 

inconsistent with its United States labeling.

Gavel® 75 DF

Fungicide

A broad-spectrum protectant fungicide for disease control in potatoes, grapes, cucurbits, 

tomatoes, onions (dry blub), garlic and shallots.

ACTIVE INGREDIENTS: % By Wt.

MANCOZEB: A coordination product of zinc ion and manganese ethylene bisdithiocarbamate..... 66.7%

In which the ingredients are:

Manganese++.....................................................................................13.3%

Zinc++..................................................................................1.7%

Ethylene bisdithiocarbamate ion (C4H6N2S4) ..............................51.7%

ZOXAMIDE: 3, 5-Dichloro-N-(3-chloro-1-ethyl-1-methyl-2-oxopropyl)-4-methylbenzamide ............. 8.3%

OTHER INGREDIENTS: .............................................................................................................. 25.0%

TOTAL 100.0%

KEEP OUT OF REACH OF CHILDREN

CAUTION

FIRST AID

If swallowed

 Call a poison control center or doctor immediately for treatment advice. 

 Have person sip a glass of water if able to swallow. 

 Do not induce vomiting unless told to do so by a poison control center or doctor. 

Do not give anything by mouth to an unconscious person.

If on skin or

clothing

 Take off contaminated clothing. 

 Rinse skin immediately with plenty of water for 15-20 minutes.

 Call a poison control center or doctor for treatment advice.

If inhaled

 Move person to fresh air.

 If person is not breathing, call 911 or an ambulance, then give artificial respiration, 

preferably by mouth-to-mouth, if possible. 

 Call a poison control center or doctor for further treatment advice. 

If in eyes

 Hold eye open and rinse slowly and gently with water for 15-20 minutes. 

 Remove contact lenses, if present, after the first 5 minutes, then continue rinsing. 

 Call a poison control center or doctor for treatment advice.

HOT LINE NUMBER 

Have the product container or label with you when calling a poison control center or doctor, or going 

for treatment. In the U.S. – In case of emergency endangering health or the environment involving 

this product call 1-888-478-0798.

Refer to inside of label booklet for Precautionary Statements and Directions for Use including 

Storage and Disposal.

NET CONTENTS _____ LBS

EPA Reg. No. 10163-6414 Produced For:

EPA Est. No. Gowan Company LLC

P.O. Box 5569

Yuma, AZ 85366

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PRECAUTIONARY STATEMENTS

HAZARDS TO HUMANS AND DOMESTIC ANIMALS

CAUTION

Causes moderate eye irritation. Avoid contact with eyes or clothing. Prolonged or frequently repeated 

skin contact may cause allergic reactions in some individuals. Wash thoroughly with soap and water 

after handling and before eating, drinking, chewing gum, using tobacco or using the toilet.

PERSONAL PROTECTIVE EQUIPMENT (PPE)

Some materials that are chemical-resistant to this product are natural rubber > 14 mils in thickness and 

barrier laminate. If you want more options, follow the instructions for category A on an EPA chemicalresistance category selection chart. 

Mixers and loaders, applicators, and other handlers must wear:

 Long-sleeved shirt

 Long pants

 Shoes and socks

 Chemical-resistant gloves made of any waterproof material

See engineering controls for additional requirements.

ENGINEERING CONTROLS

Enclosed Cockpits: Pilots must use an enclosed cockpit that meets the requirements listed in the 

Worker Protection Standard (WPS) for agricultural pesticides [40 CFR 170.240(d) (4-6)].

Mechanical Flagging Engineering Controls: Human flagging is prohibited. Flagging to support 

aerial application is limited to use of the Global Positioning System (GPS) or mechanical flaggers. 

USER SAFETY REQUIREMENTS

Follow manufacturer’s instructions for cleaning / maintaining PPE. If no such instructions for washables 

exist, use detergent and hot water. Keep and wash PPE separately from other laundry. Discard 

clothing and other absorbent materials that have been drenched or heavily contaminated with this 

product’s concentrate. Do not reuse them. 

USER SAFETY RECOMMENDATIONS

Users should:

• Wash hands before eating, drinking, chewing gum, using tobacco, or using the toilet.

• Remove PPE immediately after handling this product. 

• Wash the outside of gloves before removing. As soon as possible, wash thoroughly and change 

into clean clothing. 

ENVIRONMENTAL HAZARDS

This pesticide is toxic to fish and aquatic organisms. Drift and runoff from treated areas may be 

hazardous to aquatic organisms in neighboring areas. Do not apply directly to water, to areas where 

surface water is present, or to intertidal areas below the mean high water mark. Do not contaminate 

water when disposing of equipment washwaters or disposing of wastes. 

In Canada: Refer to label booklet for additional buffer zone information. 

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DIRECTIONS FOR USE

It is a violation of Federal law to use this product in a manner inconsistent with its labeling.

Read all Directions for Use carefully before applying. 

Do not apply this product in a way that will contact workers or other persons, either directly or through 

drift. Only protected handlers may be in the area during application. For any requirements specific to 

your State or Tribe, consult the agency responsible for pesticide regulation.

AGRICULTURAL USE REQUIREMENTS

Use this product only in accordance with its labeling and with the Worker Protection Standard, 40 CFR 

part 170. This Standard contains requirements for the protection of agricultural workers on farms, 

forests, nurseries, and greenhouses, and handlers of agricultural pesticides. It contains requirements 

for training, decontamination, notification and emergency assistance. It also contains specific 

instructions and exceptions pertaining to the statements on this label about personal protective 

equipment (PPE) and restricted-entry interval. The requirements in this box only apply to uses of this 

product that are covered by the Worker Protection Standard.

Do not enter or allow worker entry into treated areas during the restricted-entry interval (REI) of 48

hours. 

PPE required for early entry to treated areas that is permitted under the Worker Protection Standard 

and that involves contact with anything that has been treated, such as plants, soil, or water, is:

•Coveralls over long-sleeved shirt and long pants

•Chemical-resistant gloves made of any waterproof material

•Socks and chemical-resistant footwear

Notify workers that the area has been treated with a pesticide that is a dermal sensitizer by warning 

them orally and by posting warning signs at the entrances to the treated areas. The signs must be 

posted in place for 24 hours before the scheduled application and remain in place for 4 days after the 

end of the application and must state that the area has been treated with a dermal sensitizer. In 

addition, the following text must appear on the signs: “If an allergic skin reaction (rash, redness, 

swelling, itchiness) or asthma symptoms or rhinitis occurs following the use of this product report the 

incident to Gowan Company, 1-888-478-0798.” 

PRODUCT INFORMATION

Gavel 75 DF is a broad-spectrum protectant fungicide. Optimum disease control is achieved when the 

fungicide is applied in a regularly scheduled preventative spray program. The addition of an agricultural 

surfactant will improve fungicide performance by providing a more uniform spray deposit, increased 

foliar redistribution, and improved fungicide retention during periods of wet weather. 

Use Rate Determination: 

 Carefully read, understand, and follow label use rates and restrictions. 

 Under low disease conditions, minimum label rates per application can be used while maximum label 

rates and the minimum interval may be used for severe or threatening disease conditions.

 For proper application, determine the number of acres to be treated, the specified label use rate and 

the spray volume to be applied per acre. Prepare only the amount of spray solution required to treat 

the measured acreage. Carefully calibrate spray equipment before use.

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Mixing 

Slowly place into spray tank as it is being filled or thoroughly premixed in a nurse tank for concentrate 

or aircraft sprayers. Add other co-applied fungicides, insecticides, growth regulators, micronutrients, 

and spray adjuvants after Gavel 75 DF has been placed into suspension. 

Compatibility

Gavel 75 DF is compatible with most commonly used agricultural fungicides, insecticides and growth 

regulators. When preparing tank mixes, consult spray compatibility charts or State Cooperative 

Extension Service Specialists prior to actual use. 

When using Gavel 75 DF in a tank mixture, observe all directions for use, precautions and limitations, 

which appear on the label of the tank mix partner.

Spray Adjuvants

The addition of agricultural surfactants to Gavel 75 DF sprays will improve initial spray deposits, 

fungicide redistribution and weatherability. 

Suspend Gavel 75 DF into the spray solution prior to adding an adjuvant. Read and carefully observe 

the precautionary statements and all other information appearing on both product labels prior to spray 

preparation. 

Application

Ground: Thorough coverage foliar sprays generally result in optimum disease control. To achieve 

good coverage use proper spray pressure, gallonage per acre, nozzles (generally hollow cone), disc 

(generally D-5 to D-7), nozzle spacing, and tractor speed. Consult spray nozzle and accessory 

catalogues for specific information on proper equipment calibration.

Spray Volume: For ground applications on potatoes, cucurbits, tomatoes, onion (dry bulb), 

garlic and shallots, 2 to 3 gallons of spray per acre are generally optimum; apply spray volumes 

of 5 gallons per acre to vineyards. Some tall or dense vines, requiring greater penetration to the 

lower leaf surface will require higher spray volumes. DO NOT USE LESS THAN 5 GALLONS 

PER ACRE IN CALIFORNIA OR 2 GALLONS IN ALL OTHER STATES.

Aerial: A uniform initial spray deposit over the crop canopy generally results in optimum disease 

control. Pre-check each aircraft for droplet size, uniformity of spray pattern, swath width, and spray 

volume. During aerial application, human flaggers are prohibited. 

Nozzle selection: Hollow cone brass nozzles with a D-series orifice disc and core (whirl plate) 

are recommended. Nozzles should point straight down or slightly backward. 

Swath width: For most field and vegetable crops, swaths just beyond the wingspan of 36 to 40 

feet for light aircraft and up to 45 feet for heavier aircraft are suggested. Optimum swath for 

helicopters is usually 5 to 10 feet beyond normal boom length.

Spray Volume: Aerial applications are to be made in a minimum of two (2) gallons of water per 

acre.

Altitude: Position the spray boom 5 to 10 feet above the crop canopy.

Flagging: Mark swaths with permanent flags at the end of the field. Measure swaths accurately 

with a chain or other device except when rows can be accurately counted. 

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Spray Drift Management (Aerial Application)

A variety of factors including weather conditions (e.g., wind direction, wind speed, temperature, relative 

humidity) and method of application (e.g., ground, aerial, airblast, chemigation) can influence pesticide 

drift. The applicator must evaluate all factors and make appropriate adjustments when applying this 

product. 

Wind Speed: 

Do not apply at wind speeds greater than 15 mph. 

Temperature Inversions:

If applying at wind speeds less than 3 mph, the applicator must determine if a) conditions of 

temperature inversion exist, or b) stable atmospheric conditions exist at or below nozzle height. Do not 

make applications into areas of temperature inversions or stable atmospheric conditions. 

Other State and Local Requirements:

Applicators must follow all state and local pesticide drift requirements regarding application of 

mancozeb. Where states have more stringent regulations, they must be observed. 

Equipment:

All aerial and ground application equipment must be properly maintained and calibrated using 

appropriate carriers or surrogates. 

Additional requirements for aerial applications:

1. The boom length must not exceed 75% of the wingspan or 90% of the rotor blade diameter.

2. Release spray at the lowest height consistent with efficacy and flight safety. Do not release spray at 

a height greater than 10 feet above the crop canopy unless a greater height is required for aircraft 

safety. 

3. When applications are made with a crosswind, the swath must be displaced downwind. The 

applicator must compensate for this displacement at the up and downwind edge of the application area 

by adjusting the path of the aircraft upwind. 

Additional requirements for ground boom application:

1. Do not apply with a nozzle height greater than 4 feet above the crop canopy. 

Chemigation Use Directions

Sprinkler Irrigation

Gavel 75 DF must be applied on a regular protectant fungicide schedule, not an irrigation schedule. 

If irrigation cycles are less frequent than recommended Gavel 75 application intervals, ground or aerial 

applications must supplement chemigation applications to achieve adequate disease control. 

 Apply Gavel 75 DF only through sprinkler irrigation systems including center-pivot, lateral move, end 

tow, side (wheel) roll, traveler, solid set or hand move irrigation systems. Do not apply this product 

through any other type of irrigation system.

 Lack of fungicidal effectiveness or illegal pesticide residues in the crop can result from non-uniform 

distribution of treated water. 

 If you have questions about calibration, you should contact State Extension Service specialists, 

equipment manufacturers, or other experts. 

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 Do not connect an irrigation system (including greenhouse systems) used for pesticide application to 

a public water system unless the pesticide label-prescribed safety devices for public water system are 

in place. 

 A person knowledgeable of the chemigation system and responsible for its operation, or under the 

supervision of the responsible person, shall shut the system down and make necessary adjustments 

should the need arise.

Before applying Gavel 75 DF through sprinkler irrigation equipment, the chemigation system 

must meet the following specifications: 

 Public water system means a system for the provision to the public of piped water for human 

consumption if such system has at least 15 service connections or regularly serves an average of at 

least 25 individuals daily at least 60 days out of the year.

 Chemigation systems connected to public water systems must contain a functional, reduced-pressure 

zone (RPZ), backflow preventer or the functional equivalent in the water supply line upstream from 

the point of pesticide introduction. As an option to the RPZ, the water from the public water system 

should be discharged into a reservoir tank prior to pesticide introduction. There shall be a complete 

physical break (air gap) between the outlet end of the fill pipe and the top or overflow rim of the 

reservoir tank of at least twice the inside diameter of the fill pipe. 

 Systems not connected to a public water supply must contain a functional check valve, vacuum relief 

valve, and low-pressure drain appropriately located in the irrigation pipeline to prevent water source 

contamination from back flow. 

 The pesticide injection pipeline must contain a functional, automatic, quick-closing check valve to 

prevent the flow of fluid back toward the injection pump. 

 The pesticide injection pipeline must also contain a functional, normally closed, solenoid-operated 

valve located on the intake side of the injection pump and connected to the system interlock to 

prevent fluid from being withdrawn from the supply tank when the irrigation system is either 

automatically or manually shut down.

 The system must contain functional interlocking controls to automatically shut off the pesticide 

injection pump when the water pump motor stops, or in cases where there is no water pump, when 

the water pressure decreases to the point where pesticide distribution is adversely affected.

 The irrigation line or water pump must include a functional pressure switch, which will stop the water 

pump motor when the water pressure decreases to the point where pesticide distribution is adversely 

affected. 

 Systems must use a metering pump, such as a positive displacement injection pump (e.g. diaphragm 

pump) effectively designed and constructed of materials that are compatible with pesticides and 

capable of being fitted with a system interlock.

 Do not apply when wind speed favors drift beyond the area intended for treatment.

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Project ID: KRF20131
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Center-pivot, Lateral Move, End Tow, and Traveler Irrigation Equipment (use only with electric 

or oil hydraulic drive systems, which provide a uniform water distribution):

 Determine size of area to be treated. 

 Determine the time required to apply no more than 1⁄4 inch water (6,750 gallons water per acre) over 

the area to be treated when the system and injection equipment are operated at normal pressures 

recommended by the equipment manufacturer. Run system at 80 to 95% of manufacturer’s rated 

capacity. 

 Using only water, determine the injection pump output when operated at normal line pressure. 

 Determine the amount of Gavel 75 DF required to treat area. 

 Add the required amount of Gavel 75 DF and sufficient water to meet the injection time requirements 

of the solution tank. 

 Maintain constant solution tank agitation during the injection period. 

 Stop injection equipment after treatment is completed. Continue to operate the system until Gavel 75

DF solution has cleared the sprinkler head. 

Solid-set, Side (wheel) Roll, and Hand Move Irrigation Equipment:

 Determine acreage covered by sprinkler.

 Fill injector solution tank with water and adjust flow rate to use contents over a 10 to 30 minute 

interval.

 Determine the amount of Gavel 75 DF required to treat area.

 Add the required amount of Gavel 75 DF into the same quantity of water used to calibrate the 

injection equipment. 

 Maintain constant solution tank agitation during the injection period.

 Operate system at normal pressures recommended by the manufacturer of the injection equipment 

and used for the time interval established during calibration.

 Inject Gavel 75 DF at the end of the irrigation cycle or as a separate application to maximize foliar 

fungicide retention. 

 Stop injection equipment after treatment is completed. Continue to operate the system until Gavel 75

DF solution has cleared the last sprinkler head. 

Restrictions

Users must carefully read, understand, and follow all use restrictions prior to using Gavel 75 DF . 

Foliar Applications

Where EBDC Products Used Allow the Same Maximum Poundage of Active Ingredient Per Acre 

Per Season: If more than one product containing an EBDC active ingredient (maneb, mancozeb, or 

metiram) is used on a crop during the same growing season and the EBDC products used allow the 

same maximum poundage of active ingredient per acre per season, then the total poundage of all such 

EBDC products used must not exceed any one of the specified individual EBDC product maximum 

seasonal poundage of active ingredient allowed per acre. 

Where EBDC Products Used Allow Different Maximum Poundage of Active Ingredient Per Acre 

Per Season: If more than one product containing an EBDC active ingredient is used on a crop during 

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the same growing season and the EBDC products used allow different maximum poundage of active 

ingredient per acre per season, then the total poundage of all such EBDC products used must not 

exceed the lowest specified individual EBDC product maximum seasonal poundage of active ingredient 

allowed per acre. 

Seed Treatment: In addition to the maximum number of foliar applications permitted by the 

formula stated above, a single application for seed treatment may be made on crops that have 

registered seed treatment uses.

Rotational Crop Restrictions: The following rotational crops may be planted at intervals defined 

below, following the final application of Gavel 75 DF at the specified rates for a registered use: 

Crops with uses on this label: No Restrictions

All Other Crops: 30 Days

USE DIRECTIONS BY CROP

Cucurbits, including the following:

Chayote, Chinese waxgourd, Citron Melon, Gherkin, Edible Gourd, Momordica spp,

Cucumber (Cucumis sativus)

Melons: cantaloupe, casaba, crenshaw, honeydew, muskmelon

Pumpkin

Squash, summer (Cucurbita pepo var. melopepo) including: crookneck squash, scallop squash, 

straightneck squash, vegetable marrow and zucchini

Squash, winter

Watermelon including hybrids and/or varieties of Citrullus lanatus

Diseases 

Controlled

Rate of

Gavel 75 DF

(lb./Acre)

Remarks

(See Also Directions for Use)

Alternaria leaf spot

Cercospora leaf spot

Downy Mildew

Phytophthora rot

(Phytopthora capsici)

1.5 to 2.0

(1.0 to 1.33 lbs.

mancozeb and 

0.12 to 0.17 lbs.

zoxamide) 

Start applications when plants are in the two-leaf stage 

and repeat at 7 to 10 day intervals or when environmental 

conditions are favorable for disease development. Use 

sufficient water and direct sprays to provide thorough 

coverage of foliage, stems and developing fruit. 

Some cantaloupe varieties (i.e.: Harvest Queen, Gold 

Star, Super Star, Sweet and Early, and Saticoy) are 

sensitive to Gavel 75 DF. Consult State Cooperative 

Extension Service Specialist prior to use. 

 Do not make more than 8 applications or apply more than 16 lbs. (10.67 lbs.

mancozeb and 1.33 lbs. zoxamide) per acre per season. 

 Do not apply within 5 days of harvest.

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Grapes

Diseases 

Controlled

Rate of

Gavel 75 DF

(lb./Acre)

Remarks

(See Also Directions for Use)

Bunch Rot

Downy Mildew

Phomopsis

Pre-bloom Sprays

At-bloom Sprays

Post-bloom Sprays

2.0 to 2.5

(1.33 to 1.67 lbs.

mancozeb and 

0.16 to 0.20 lbs.

zoxamide) 

Apply in sufficient water to provide thorough coverage 

starting when new shoots are 1/2 to 1 1/2 inches long. 

Repeat when shoots are 3 to 5 inches long, when shoots 

are 8 to 10 inches long, and then at 7 to 10 day intervals.

 In California, do not apply after a bloom. In other areas, do not apply within 

66 days of harvest. 

 West of the Rocky Mountains, do not make more than 3 applications or

apply more than 7.5 lbs. (5 lb. mancozeb and 0.62 lb. zoxamide) per acre 

per season.

 East of the Rocky Mountains, do not make more than 6 applications or apply 

more than 15 lbs. (10 lb.mancozeb and 1.25 lbs. zoxamide) per acre per 

season.

Potatoes

Diseases 

Controlled

Rate of

Gavel 75 DF

(lb./Acre)

Remarks

(See Also Directions for Use)

Late blight

Early blight

1.5 to 2.0

(1.0 to 1.33 lbs.

mancozeb and 

0.12 to 0.17 lbs.

zoxamide)

Begin applications at the first sign of disease or when late 

blight is reported in the area. Use a 5 to 7 day schedule 

when late blight is present and environmental conditions 

favor continued disease development.

Under low disease conditions and environmental

conditions unfavorable for disease development, a 7 to 10 

day application schedule may be used. 

Increase the use rate according to vine development. 

Use the maximum labeled rate at row fill. 

 Do not make more than 6 applications or apply more than 12 lbs. (8.0 lbs.

mancozeb and 1.0 lb. zoxamide) per acre per season crop. 

 Do not apply within 3 days of harvest in Connecticut, Delaware, Florida, 

Maine, Massachusetts, Michigan, New Hampshire, New York, Ohio, 

Pennsylvania, Rhode Island, Vermont and Wisconsin and at least within 14

days elsewhere. 

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Tomatoes

Diseases 

Controlled

Rate of

Gavel 75 DF

(lb./Acre)

Remarks

(See Also Directions for Use)

Buckeye rot

Early blight

Gray leaf spot

Late blight

Leaf mold

Septoria leaf spot

1.5 to 2.0

(1.0 to 1.33 lbs.

mancozeb and 

0.12 to 0.17 lbs.

zoxamide)

Start applications when seedlings emerge or transplants 

are set and repeat at 7 to 10 day intervals or when 

environmental conditions are favorable for disease 

development.

Bacterial speck

Bacterial spot

Use a full rate of fixed copper fungicide in tank mix 

combinations with a full rate of Gavel 75 DF.

 West of the Mississippi River, do not make more than 4 applications or apply 

more than 8 lbs. (5.33 lbs. mancozeb and 0.66 lb. zoxamide) per acre per 

season.

 East of the Mississippi River, do not make more than 8 applications or apply 

more than 16 lbs. (10.67 lbs. mancozeb and 1.33 lbs. zoxamide) per acre 

per season.

 Do not apply within 5 days of harvest. 

 

Onions (dry bulb), Garlic and Shallots

Diseases

Controlled

Rate of

Gavel 75 DF 

(lb./Acre)

Remarks

(See Also Directions for Use)

Botrytis leaf blight

Downy mildew

Neck rot

Purple blotch

Rust

1.5 to 2.0

(1.0 to 1.33 lbs. 

mancozeb and 

0.12 to 0.17 lbs. 

zoxamide)

Follow a protective spray schedule starting when diseases 

are first reported in the area and repeat at 7 day intervals 

throughout the season.

Do not allow spray or drift to contact bulbs after lifting from 

soil.

 Do not apply within 7 days of harvest.

 Do not make more than 8 applications or apply more than 16 lbs. (10.67 lbs.

mancozeb and 1.33 lbs. zoxamide) per acre per season.

 Do not apply to exposed bulb.

 

Each pound of Gavel 75 DF contains 0.67 lbs. of mancozeb. When using Gavel 75 DF with 

other mancozeb containing products do not exceed 19.2 pounds of mancozeb for cucurbit 

labeled crops, 6 and 19.2 pounds for grapes grown west and east of the Mississippi River, 

respectively, and 11.2 pounds of mancozeb for potato and 6.4 and 16.8 pounds of mancozeb 

for tomatoes grown west and east of the Mississippi River, respectively.

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Project ID: KRF20131
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ATTENTION: This product contains mancozeb and ETU, chemicals known to the State of 

California to cause cancer. ETU is also known to the State of California to cause birth defects 

or other reproductive harm.

FOR 24-HOUR EMERGENCY ASSISTANCE (SPILL, LEAK OR FIRE), 

CALL CHEMTREC®(800) 424-9300.

For other product information, contact Gowan Company or see Material Safety Data Sheet.

NOTICE OF CONDITIONS OF SALE AND WARRANTY AND LIABILITY LIMITATIONS

Important: Read the entire Directions for Use and Notice of Conditions of Sale and Warranty and 

Liability Limitations before using this product. If terms are not acceptable return the unopened container 

for a full refund.

Our directions for use of this product are based on tests believed to be reliable. However, it is 

impossible to eliminate all risk associated with the use of this product. Crop injury, inadequate 

performance, or other unintended consequences may result due to soil or weather conditions, off target 

movement, presence of other materials, method of use or application, and other factors, all of which are 

beyond the control of Gowan Company. To the extent consistent with applicable law, all such risks are 

assumed by the Buyer and User.

Gowan Company warrants that this product conforms to the specifications on the label when used in 

strict conformance with Directions for Use, subject to the above stated risk limitations. TO THE 

EXTENT CONSISTENT WITH APPLICABLE LAW, GOWAN COMPANY MAKES NO OTHER 

EXPRESS OR IMPLIED WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR 

PURPOSE NOR ANY OTHER EXPRESS OR IMPLIED WARRANTY. 

TO THE FULLEST EXTENT CONSISTENT WITH APPLICABLE LAW, GOWAN COMPANY’S 

EXCLUSIVE LIABILITY FOR ANY AND ALL LOSSES, INJURIES OR DAMAGES RESULTING FROM 

THE USE OR HANDLING OF THIS PRODUCT WHETHER IN CONTRACT, WARRANTY, TORT, 

NEGLIGENCE, OR ANY OTHER LEGAL THEORY IS STRICTLY LIMITED TO THE PURCHASE 

PRICE PAID OR REPLACEMENT OF PRODUCT, AT CANYON GROUP’S SOLE DISCRETION.

Gavel ® is a registered trademark of Gowan Company, LLC. 

Chemtrec®is a registered trademark of American Chemistry Council, Inc.

EPA Text Pending: Gavel 75DF (to EPA 07-11-13)

Storage and Disposal

Do not contaminate water, food or feed by storage and disposal. 

Pesticide Storage: Keep away from fire and sparks. Store in a cool, dry, well-ventilated area. Do 

not allow to become wet or overheated in storage; decomposition, impaired activity, or fire might 

result. Keep container closed when not in use. Decomposition produces a foul odor; if observed, 

check for hot containers and immediately remove to open areas for disposal.

Pesticide Disposal: Wastes resulting from the use of this product may be disposed of on-site or at 

an approved waste disposal facility.

Container Disposal: Nonrefillable container. Do not reuse or refill this container. Completely

empty bag into application equipment. Clean container promptly after emptying. Then offer for 

recycling if available or dispose of empty bag in a sanitary landfill, or by incineration, or, if allowed by 

state and local authorities, by burning. If burned, stay out of smoke.

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Project ID: KRF20131