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### R EPORT TITLE Tolerance Petition F or Zoxamide On Dry Bulb O nions

D ATA REQUIREMENTS Not Applicable

A UTHOR Karina Flores

C OMPLETION DATE July 22 , 2013

P ERFORMING LABORATORY Not Applicable

S PONSOR Gowan Company P.O. Box 5569 Yuma, AZ 85366

P ROJECT IDENTIFICATION KRF201314 of 3 6 

### 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 1 1 Section E : Practical Methods for Removing Residues That Exceed Any Proposed Tolerance 1 1 Section F : Proposed Tolerances for th e Pesticide Chemical 12 Section G : Reasonable Grounds In Support Of the Petition 1 4 Appendix I : Notice of Filing 20 Appendix II: Gavel 75DF Label

Volume I I of I I : 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 75 DF ( 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 Internati onal (also known as Gowan Company) pu rchased the worldwide z oxamide b usiness from Dow AgroSciences. With this acquisition, licensed commercial rights and regulatory responsibility were granted to Gowan Company. Gowan Company seek s to establish a t olerance 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 zoxamid e in or on dry bulb onions (C rop G roup 3 , Bulb Vegetables ). In support of this petition, twelve residue programs using Gavel 75DF were conducted in various NAFTA Regions during th e 2011 an d 2012 growing seasons to fulfill a U.S. and Canadian tolerance. Gavel 75DF is com prised of 66% m ancozeb and 8.3% zoxamide . As the current mancozeb tolerances published in 40 CFR § 180.176 support dry bulb onions uses proposed by this petitio n, 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 th is document
. An electronic copy of a draft N otice of F iling, formatted using EPA T emplate No. P25 in Microsoft Word (.wpd) , will be e
- mailed to the EPA Regist ration 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)
- p toluamide 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 St ructural Formula:

Molecular Formula: C 14 

### H 16 

### NO 2 

### Cl 3 

### Molecular Weight: 336.65 R e s idue Definition : P er 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 determine d by measuring only zoxamide ( 3, 5
- dichloro
- N
- (3
- chloro
- 1
- ethyl
- 1
- methyl
- 2
- oxopropyl)
- 4
- methylbenzamide).

Commodity Parts per million7 of 3 6 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 t he stoichiometric equivalent of zoxamide, in or on t he following commo dities : 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 seek s 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 o f 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 recommend ed 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 I I 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 Raw8 of 3 6 

### Agricultural Commodities Following Eight Foliar Applications of Gavel® 75DF F ungicide

— 2011 ” which is also submitted concurrently with this petition in Volume II
. Gowan Company propose s 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 ap ply more tha n 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 ingre dients 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. Rate 1 lbs. AI/A (PHI in days) Max Single App. Rate 2 lbs. AI/A (PHI in days) Max Single App. Rate tested 3 lbs. AI/A (PHI in days) Max. Seasonal Application Rate lbs. AI/A Gavel 75DF 1 Rate: 1.5
- 2.0 lbs./A PHI: 7 days Mancozeb 1.33 (7) 2.4 (7) N/A 24 2 Zoxamide 0.166 (7) N/A 0.17 (7) 1.33 3
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. A n 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 p erformed (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, t he 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 fema les )
. In addition, a rat and rabbit developmental studies (MRID No s. 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). W hen administered orally by gavage to pregnant rabbits, the NOEL for maternal toxicity greater than or equa l 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 re moved 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 Di etary 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 significa ntly 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%10 of 3 6 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%

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



### Section D: Analytical Method and Proposed Tolerances T he 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 ; r efer 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 z oxamide, 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 l ast 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 - 1452 b RH - 1455 b Total Residue c Dry Bulb Onion <0.02
- 0.443 ND
- 0.0529 ND 0.0391
- 0.443 a <0.02 ppm represents values <LOQ b Reported as parent (zoxamide) equivalent c For 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 we re analyzed. Validation for zoxamide, RH
- 1452, and RH
- 1455 for dry bulb onions consist ed of11 of 3 6 

### analyzing two untreated control samples, three untreated control samples fortified at the limit of quantification (LOQ) per analyte, and three untreated control samples fortifie d at 10× the LOQ per analyte.

S ection 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 determ ine 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 . E ight foliar broadcast applications of Gavel 75DF Fungicide at the maximu m 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 s upport a U.S. and Canadian tolerance
. The results from these trials show ed that after eight applications of Gavel® 75DF Fungicide at the proposed rate, z oxamide resi dues ranged from <0.02 ppm (0.0159) to 0.443 ppm (mean = 0.163 ppm ± 0.115) on 24 bulb oni on 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 sample s. 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 0.026 6, 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 half
lives for zoxamide, RH
- 1452, and total zoxamide were 15.4, 81.5, and 17.0 days, respectively.12 of 3 6 

### Per OPPTS Guideline 860.10 0, neither a processing nor feeding study is required for this commodity (C rop G roup 3 , Bulb Vegetables ). Gowan Company propose s 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 res idue 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 zox amide 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 z oxamide, 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 o n 24 bulb onion treated samples. EPA has evaluated the avail able toxicity data and considered it s validity, completeness , and reliab ility 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 onion s and the established tolerance for mancozeb on onions.13 of 3 6 

### There were no omissions or substitutions of the required data or information as required per 40 CFR 180.7
.14 of 3 6 

## APPENDIX I: Notice of Filing15 of 3 6 

# 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 z oxamide (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 whethe r 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.16 of 3 6 

### The total radioactive residues recovered in the potato r esidue 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 tota l 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 perfor med 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 vacuu m 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 ester s (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 LD 50 

### 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 LD 50 

### > 2,000 mg/kg (males and females combined) while an inhalation study produced an LC 50 

### > 5.3 mg/L (MRID No. 44731808). A p rimary 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. 4473181 2).17 of 3 6 

### 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 t he 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 d oses 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 (lim it 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). W hen 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/k g/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 u p to 102118 of 3 6 

### 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 live r 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 lar ge 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 f or 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 stoichiomet ric 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 Agen cy 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 evi dence 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 s light 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 z oxamide.] 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 to lerances published in 40 CFR §180.176 support bulb onions uses.]19 of 3 6 

### 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 po tential 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 NOE L 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 bill ion (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 determin e 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 to lerance 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 G roup 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.]20 of 3 6 

## APPENDIX II : Gavel 75DF Label

### 1 GROUP M 22 FUNGICIDE



## GAVEL ® 

## 75DF Fungicide AGRICULTURAL READ THE LABEL AND BOOKLET BE FORE USING KEEP OUT OF REACH OF CHILDREN

CAUTION ACTIVE INGREDIENTS/GUARANTEE: % By Wt. MANCOZEB: A coordination product of zinc ion and manganese ethylene bisd ithiocarbamate

..... 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 a llergic 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 Co mpany 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 I MPORTANT NOTICE This product is registered in both the U.S. and Canada. It has BOTH U.S. and Canada Labeling.

Y ou 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.

### 2 FIRS T 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 immediate ly 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 pres ent, 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.
TOXI COLOGICAL 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 container s 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.

### 3 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 d es 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% PRÉC AUTIONS 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 I N THE UNITED STATES PPE and Disposal - Re fer 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 f ollowing 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 book let. If terms are unacceptable, return at once unopened. I N 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 thi s 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 SEU LEMENT l’étiquette canadienne en UTILISANT CE produit au Canada.

### 4

personnes. Dangereux si inhalé. Éviter de respirer les poussières. Enlever les vêtements contaminés et les laver avant de les remettre. Ce pro duit 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 numéro s 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 vom ir 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 con eils 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 réaction s 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.

### 5 RISQUES POUR L’ENVIRONNEMENT Ce pesticide est toxique po ur 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 s ur les zones tampons.
A UX É TATS - 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’explo itation 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. A U 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 décomp osition, 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.

### 6 U.S. LABEL GROUP M 22 FUNGICIDE I t 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 ,

tomat oes , onions (dry blub), garlic and shallots . ACTIVE INGREDIENT S : % 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 (C 4 H 6 N 2 S 4 )

........................ .. ....5 1.7% 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 b y 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 Ha ve 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 lab el 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

### 7 PRECAUTIONARY STATEMENTS HAZARDS TO HUMANS AND DOMESTIC ANIMALS

CAUTION Causes moderate eye i rritation. 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 afte r 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 n atural rubber > 14 mils in thickness and barrier laminate. I f yo u want more options, follow the instructions for category A on an EPA chemical resistance category selection chart. Mixers and loaders, applicators, and other handlers must wear:
 Long - sleeved shirt
 Long pants
 Shoes and socks
 Chemical
- resistant gloves mad e of any waterpr oof 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 pes ticides [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. U SER 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 dre nched 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 th is 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 haza rdous to aquatic organisms in neighboring areas. D o 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 o f wastes. In Canada: Refer to label booklet for additional buffer zone information.

### 8 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 applyi ng. 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 requirement s specific to your State or Tribe, consult the agency re sponsible 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 worker s 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 t reated areas during the restr icted - 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, understa nd, 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 applica tion, determine the number of acres to be treated, the specified l abel 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.

### 9

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 i s compatible with most commonly used agricultural fungicides, insecticides and growth regulators. When preparing tank mixes, consult spray compatibility charts or State Cooperative Extensio n Service Specialists prior to actual use. When using Gavel 75 DF i n 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 infor mation appearing on both product labels prior to spray preparation. A pplication Ground: Thorough coverage foliar sprays generally result in optimum disease control. To achieve good coverage use proper spray pressure, gallonage per acre, nozzles (general ly 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 applicat ions on potatoes, cucurbits, tomato es , onion (dry b ul b), 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 highe r 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 e ach 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.

### 10 Spray Drift Management (Aerial Application) A variety of factors including weather conditions (e.g., wind direction, wind speed, tempe rature, 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 heig ht. 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 st ates 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 regul ar 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 contro l.

 Apply Gavel 75 DF onl y through s prinkler 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 knowledgeab le 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 e quipment, 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 aver age 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), back flow preventer or the functional equivalent in the water supply line up stream 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 out let 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 inje ction 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 sup ply 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 n o water pump, when the water pres sure 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 decre ases 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 pestic ides 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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Center - pivot, Lateral Move, End Tow, and Traveler Irrigation Equipment (use only with electric or oil hydraul ic 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 e quipment 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 amo unt 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 eq uipment 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 solut ion 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 equ ipment.
 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 Gave l 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 pr oduct 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 ing redient per acre per season, the n the total poundage of all su ch 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: I f 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 pro ducts 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 sin gle 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, Cucum ber (Cucumis sativus) Melons: cantaloupe, casaba, c renshaw, honeydew, muskmelon Pumpkin Squash, summer (Cucurbita pepo var. melopepo) including: crookneck squash, scallop squash, straightneck squash, vegetable m arrow 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 dire ct 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 S pecialist prior to use.
 Do not make more than 8 applications or apply more than 16 lb s . (10.67 lb s . mancozeb and 1.33 lb s . 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 cove rage

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, d o not apply withi n 66 days of harvest.
 West of the Rocky Mountains, do not make more than 3 applications or apply more than 7.5 lb s . (5 lb

. m ancozeb 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 lb s . (10 lb

. m ancozeb and 1.25 lb s . zoxamide) per acre per s eason.
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 l bs

. 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 con ditions 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 applicatio ns or apply more than 1 2 lb s . ( 8.0 lb s . mancozeb and 1. 0 lb

. zoxamide) per acre per season crop .  Do not apply within 3 days of h arvest in Connecticut, Delaware, Florida, Maine, Massachusetts, Michigan , New Hampshire, New York, Ohio, Pennsylvania, Rhode I sland, 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 lb s . (5.33 lb s . mancozeb and 0.66 lb

. zoxam ide) per acre per season .  East of the Mississippi River , do not make more than 8 applications or apply more than 16 lb s . (10.67 lb s . mancozeb and 1.33 lb s . zoxamide) per acre per season .  Do not apply within 5 days of harvest. Onions (dry bulb) , G arli c and S hallots Diseases Controlled Rate of

Gavel 75 DF (lb./Acre) Remarks (See Also Directions for Use) Botryt is 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 protec tive 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 contain ing 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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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 repro ductive 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 W ARRANTY 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 du e 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 assum ed 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 F ULLEST 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 0 7 - 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 no t reuse or refill this container. Complet ely 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.