# EPA Registration Jacket 87284

‐ 2

# MATERIAL TO BE ADDED TO JACKET

REG#

Description:



# csF

\

## ~ 

# v( S / c:> "" 

# Y3(,t3K

**check all**  **that applv** 



# d

new stamped accepted label (I)



# CD



# :;:,

# ~ Q..



# new CSF 

# - 0 .•

(")



# 0 notification (I)



# (")

, , "



# Instructions:

Attach this sheet to the top of ALL 

## material sent to the file room (both loose paper and

new material in jackets). This sheet will be imaged; a clear description will aid in

finding material in the e-jacket. Remove staples from all material. If returning loose

paper then hold together with a binder or paper clip. CSFs should be placed in the

CSF folder (if returning jacket) or covered with a red CBI sheet (if returning loose

paper). Material to be returned to file room should be place in the appropriate bin.

Reviewer's

Name:

Phone: Date:

Division:

# _--,£~LJ~ 

# __**~\if.O** S1""I'e

U.S. ENVIRONMENTAL PROTECTION AGENCY EPA Reg. Number: Date of Issuance: o ,



### If' 

# .ft \,

Office of Pesticide Programs

## s~;**~** 

## " Registration Division (7505C)



# . ' 87284-2**~~** 

# ".l I 200**Pennsytvani~** Ave., N.W.

4/. PAOif.C, Washington, D.C. 20460 

# JAtJ 

# 2 5 2011

Term of Issuance:



### NOTICE OF PESTICIDE: 

## Conditional



# .x Registration

_ Reregistration

(under FIFRA, as amended)

Name of Pesticide Product:



## Willowood Tebuconazole

Technical

Name and Address of Registrant (include ZIP Code):



## Willowood Propiconazole, LLC



## do Pyxis Regulatory Consulting

4110 136 1

• 

## St. NW

GigHarbor, WA 98332

Note: Changes in labeling differing in substance from that accepted in connection with this registration must be submitted to and accepted by the Registration

Division prior to use of the label in commerce. In any correspondence on this product always refer to the above EPA registration number.

On the basis of infoffillltion furnished by the registrant, the above named pesticide is hereby registered/reregistered under the Federal Insecticide, Fungicide and

Rodenticide Act.

Rcgistration is in no way to be construed as an endorsement or recommendation of this product by the Agency. In order to protect he:dth and the environment, the

Administrator, on his motion, may at any time suspend or cancel thc registration of a pesticide in accordance with the Act. The acceptance of any name in

connection with the registration of a product under this Act is nO! to be construed as giving the registrant a right to exclusive use of the name or to its use if it has

been covered by others.



## This product is conditionally registered in accordance with 

## FIFRA section 3(c)(7)(A) provided that

you:

I) 

## Submit and/or cite all data required for registration of your product under FIFRA sec 3(c)(5) when

the Agency requires all registrants of similar products to submit such data; and submit acceptable

responses required for reregistration of your product under FIFRA section 4.

2) Make the following label change:

a) Revise the product registration number to read "EPA Registration Number "87284-2".

(continued on page 2)

Signature of Approving Official: Date: 

# 714:vr ci. 

# waltH

/1;),,5 

# Ii).[) 1/

Mary L. 

## Waller (21)

Fungicide Branch, Registration Division (7505P)

EPA Fonn 8570·6

## b) Place your "If Swallowed" statement first as this is the most toxic route of exposure for

this product.

c) Revise your "Terrestrial FoodlFeed Crops" to read as follows:

Terrestrial Food Crops: Asparagus, Bananas, Barley (seed and foliar treatment), Beans,

Brassica leafy greens subgroup 5B, Bulb vegetable crop group 3, Com, Cotton, Cucurbit

vegetables crop group 9, Fruiting vegetable crop group 8, Garden beets, Grapes, Grasses

grown for seed, Hops, Lychee, Mango, Oats (seed treatment), Okra, Peanuts, Pistachio,

Pome Fruit crop group 11, Soybeans, Stone Fruit crop group 12, Sunflower, Tree Nuts

crop group, Turnips, and Wheat (seed and foliar treatment)."

3) Data for storage stability (830.6317) and corrosion characteristics (830.6320) must be

submitted within the next 12 months. It is required that the observations be made at 0, 3, 6, 9

and 12 month intervals.

Submit one copy of the final printed labeling before the product is released for shipment. If

these conditions are not complied with, the registration will be subject to cancellation in

accordance with FIFRA section 6(e). Your release for shipment of the product constitutes

acceptance of these conditions. A stamped copy of the label is enclosed for your records. If you

have any further questions, please contact Tracy Keigwin of my team at (703) 305-6605 or via email at keigwin.tracy@epa.gov.

Enclosure: Sincerely,

# '1t~ 

# d Wafft,v

Mary L. 

## Waller

Product Manager (21)

Fungicide Branch

Registration Division (7505P)

Label stamped "Accepted, with comments"

Acute toxicity review

Product chemistry review

## WILLOWOOD TEBUCONAZOLE TECHNICAL

FOR USE IN FORMULATING FUNGICIDES ONLY



### ACTIVE INGREDIENT:

Tebuconazole: a-[2-(4-chlorophenyl)ethyl]-a-(1, t-dimethylethyl)-1 

### H-1 ,2,4-triazole-1-



### ethanol

................................................................................................................................. 98.5%

OTHER INGREDIENTS

........................................................................................................ 1.5%



### TOTAL.

....... ",

........ ," '"'

................ "

.............................................................. tOO.O%

IF INHALED

IF SWALLOWED

IF IN EYES:

IF ON SKIN OR



### CLOTHING: 

## KEEP OUT OF REACH OF CHILDREN

CAUTION

FIRST AID



## • 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.

• 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 the poison control center or

doctor.

• Do not Qive anything by mouth to an unconscious person.

• 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.

• 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.

Note to**Phy~ician:** No specific antidote is available. Treat asymptomaticall

. For Medical Emergencies call 24 Hours a Day t-800-858-7378. Have the product container or label with

you when calling a Poison Control Center or doctor or gOinQ for treatment.

EPA Reg. No. 87284-

Manufactured for:

Willowood Propiconazole, LLC

1600 NW Garden Valley Blvd.

Roseburg, OR 97471 

## ACCEPTED

wi 

## tlt 

## COMMENTS



## In .i.;PA Lell er Date'" 

# ( I d. 

# 5/ d.-O 

# Ii

Under Ihe 

### Fed III I FWlgi«:ide and 

# R

d lllIeetleide,

_**an.;'!lld~d** 

### , () enticlde 

### Alii, EPA Est. No.

Net Contents:

'> , ' " 

## , ,

, '



### ,

",

)



### ,



## ,

, 

### "

. , or lhe 

### pesrJ 

### fd

# =.:~~":,,,nder EPA 

# Reg. 

# N: g 

# 1 ;;t 

# r 1- J

L

.... ,!):>::

Willowood Tebuconazole Technical Label 

## "

,



## "

, ,

, 

## "

, 

### ' 

## "

, , 

## "

, 

## ", '



### " 

### "

### PRECAUTIONARY STATEMENTS

HAZARD TO HUMANS AND DOMESTIC ANIMALS

CAUTION. Harmful 

### if swallowed, absorbed through skin, or inhaled. Causes moderate eye irritation.

Avoid contact with eyes, skin or clothing. Avoid breathing dust. Wash thoroughly with soap and water

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

wash contaminated clothing before reuse.



### ENVIRONMENTAL HAZARDS

This product is toxic to mammals, fish, and aquatic invertebrates. Do not discharge effluent containing

this product directly into lakes, streams, ponds, estuaries, oceans or public waters unless in accordance



### with the requirements of a National Pollutant Discharge Elimination System (NPDES) permit and the

permitting authority has been notified in writing prior to discharge. Do not discharge effluent containing

th'ls product to sewer systems without previously notifying the local sewage treatment plant authority. For

guidance, contact your State Water Board or Regional Office of the Environmental Protection Agency.



### DIRECTIONS FOR USE

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

This product may only be used to formulate end-use products with the fOllowing uses: (1) Terrestrial Food/Feed Crops: Asparagus. Banana and Plantain, Barley (seed treatment and

foliar), Beans, Chenies, Corn, Corn (seed treatment), Cotton, Cucurbit Vegetables, Dry Bulb

Onions, Garden Beets, Grasses Grown for Seed, Garlic and Great-Headed (Elephant Garlic),

Grapes, Green Onion, Green Eschalots, Green Shallots, Hops, Japanese Bunching Onion, Leafy

Brassica Greens, Leek, Lychee, Mango (post-harvest), Nectarines, Oats (seed treatment), Okra,

Peaches, Peanuts, Pecans, Soybean, Sunflower, Scallion, Shallot, Spring Onion, Turnip, Welch

Onion, Vv'heat (seed treatment & foliar)

(2) Terrestrial non-food uses: Flowers, Ground Covers, House Plants, Ornamental Trees,

Ornamental Shrubs, Roses, Vines

(3) Wood Protection: For end use products that protect wood from wood rotting fungi and for

products that protect millwork (window frames, wood doors, doorframes, etc.), in-ground wood

products (pilings, telephone poles. wood building materials), and Sapstain control in fresh cut

lumber.

(4) uses for which US EPA has accepted the required data and/or citations of data that the fonnulator

has submitted in support of registration; and

(5) uses for experimental purposes that are in compliance with U.S. EPA requirements.

Restrictions: Do not package end use products in metal containers.



## STORAGE AND DISPOSAL

Do not contaminate water, food or feed 

### by storage or disposal.

PESTICIDE STORAGE: Store in original container tightly closed and in a safe place.

PESTICIDE DISPOSAL: Pesticide wastes are toxic. Improper disposal of excess pesticide, spray " ,**~** 

### mixture, or rinsate is a violation of Federal Law. If these wastes cannot be disposed of by use according'

s



### to label instructions. contact your State Pesticide or Environmental Control Agency, or thp, Hez'a;dous >



### Waste representative at the nearest EPA Regional Office for guidance. ' "

Container Disposal- Liner bag: Nonrefillable container. Do not reuse or refill this**cont<:lin~;.'** 

### ;

Completely empty liner into aFPlication eqUipment by shaking and tapping sides and bottom!o Icosen ,>



### clinging particles. Vv'hen completely empty offer liner bag for recycling if available or dispose d(liner in 3

### ~ sanitary landfill. Contatner Disposal- Outer Drum: Nonrefillable container. Do not**reus~** 

### bi" refl1l this •

container. Vv'hen completely empty offer for recycling if available or dispose of drum in a seni:r:.r/landfil!;..J, '"

,}'



## ,

} 

## , 

# . ,

Willowood Tebuconazole Technical Label 

### 2

### WARRANTY STATEMENT

IMPORTANT NOTICE 

### -Seller warrants that this product conforms to the chemical description and is

reasonably fit for purposes slated on the label when used in accordance with the directions and

instructions under normal conditions of use; but neither this warranty nor any other warranty of

merchantability or fitness for a particular purpose, express or implied, extends to the use contrary to label

instructions, or under conditions not reasonably foreseeable to seller, and to the extent consistent with



### applicable law, buyer assumes the risk of any such use.

"",



## ,

, '



## ,

, , , 

### " 

## , 

## "

, '

, 

## , , , 

## "

, , > >



### , 

## , , 

# .

Willowood Tebuconazole Technical Label 

### 3FormApprovedOMSNo.UNITEDSTATESENVIRONMENTALPROTECTIONAGENCY401MStreet,S.W.WASHINGTON,D.C.20460PaperworkReductionActNotice:Thepublicreportingburdenforthiscdlectionofinformationisestimatedtoaverage025hoursperresponseforregistrationactivitiesand0.25hoursperresponseforreregistrationandspecialreviewactivities,includingtimefOrreadingtheinstructionsandcompletingthenecessaryforms.Sendcommentsregardingtheburdenestimateoranyotheraspectofthiscollectionofinformation,includingsuggestionsforreducingtheburdento:Director,OPPEInformationManagementDivision(2137),U.S.EnvironmentalProtectionAgency,401MStreet,S.w.,Washington,DC20460.Donotsendtheformtothisaddress.DATAMATRIXDateJan.24,2011EPARea.No.lFileSvmbolIPage/of8Applicant'siRegistrant'sName&AddressProductWillowoodpropiconazole,LLCWillowoodTebuconazoleTechnical1600NWGardenValleyBlvd.Roseburg,OR97471InaredientTebuconazoJe(CASNo.107534..96-1LGuideflneReferenceNumberJGuideflneStudyNameMRIONumberSubmitterStatusNot.ProductSpecifiCDataRequirements830.1550ProductIdentitvandComoosition48143701WillowoodProoiconazole,LLCOWN830.1600DescriptionofMaterialsUsedtoProducethe48143701WillowoodPropiconazole,LLCOWNProduct830.1620DescriplionofProductionProcess48143701Willowoodpropiconazole,LLCOWN830.1650DescriotionofFormulationProcessNotReauired1830.1670DiscussionofFormationofImpurities48143701WillO'NoodPropiconazole,LLCOWN830.1700PreliminarvAnalvsis48143702WillowoodProoiconazole,LLCOWN830.1750CertifiedLimits48t43701WillowoodPropiconazole,LLCOWN830.1800EnforcementAnalvticalMethod48143701WiUowoodProoiconazole,LLCOWN830.6302Color48143703WillowoodPropiconazole,LLCOWN830.6303PhysicalState48143703WilJowoodPropiconazoleLLCOWN830.6304Odor48143703WillowoodProoiconazole,LLCOWN830.6313StabilitytoNormalandElevatedTemperatures,48t43703WillowoodPropiconazole,LLCOWNDataMetals,andMetalIons48143704OWNWaiverSlgnalureNameandTitleOaleAnnM.Tillman,ConsultantJan.24,2011-EPAForm6570-35(9-97)ElectronicandPaperversionsavailable.SUbmitonlypaperYef$ion.AgencyInwrnalUseCopyFormApprovedOMBNo.2070-0060UNITEDSTATESENVIRONMENTALPROTECTIONAGENCY401MStreet,S.W.WASHINGTON,D.C.20460PaperworkReductionActNotice:Thepublicreportingburdenforthiscollectionofinformationisestimatedtoaverage0.25hoursperresponseforregistrationactivitiesand0.25hoursperresponseforreregistrationandspecialreviewactivities,inctudingtimeforreadingtheinstructionsandcompletingthenecessaryforms.Sendcommentsregardingtheburdenestimateoranyotheraspectofthiscollectionofinformation,includingsuggestionsforreducingtheburdento:Director,OPPEInformationManagementDivision(2137),U,s.EnvironmentalProtectionAgency,401MStreet,S.W.,Washington,DC20460.Donotsendtheformtothisaddress.__0"DATAMATRIXDateJan.24.2011EPARen.No.lFileSvmbol87284-EIPao.2of8Applicant's/Registrant'sName&AddressProductWillowoodPropiconazole,LLCWillowoodTebuconazoleTechnical1600NWGardenValleyBlvd.OR97471Tebuconazol;-(CASNo.107534-96-3\GuidelineReferenceNumberGuidelineNameMRIDNumberSubmitterStatusN...830.6314Oxidation/Reduction:ChemicalIncompatibilitv48143703WillowoodPropiconazoleLLCOWN830.6315Flammabilitv48143704WillowoodProoiconazole,LLCOWN830.631648143704WillowoodProoiconazole,LLCOWNWaiver4830.6317StoraaePRN92_55830.6319MiscibilitvNotReouired6830.6320CorrosionCharacteristicsPRN92-55../830.6321DielectricBreakdownVoltaaeNotReouired6830.7000InH48143703Wi!lowoodProoiconazole,LLCOWN830.7050UVNisibleAbsorotion48143703WillowoodProoiconazoleLLCOWN830.7100Viscositv48143704WillowoodProoiconazole,LLCOWNWaiver7830.7200MeltinnPointlMeltinQRance48143703WillowoodPropiconazoleLLCOWN830.7220BoilinaPoint/BeHinaRanceNotReauired8830.7300Densitv/RelativeOensitv/BulkOensitv48143703WillowoodProoiconazole,LLCOWN830.7370D'lssociationConstantsinWater48143704WllowoodPropiconazole,LLCOWNWaiver'SlgnalureNameandnUeo<t.4..1.NdLAnnM.Tillman,ConsultantJan.24,20t1EPAForm9570-35(9-97)ElectrQnicandPapervel"$ionsSubmllonlypaperYOOlion.AgencyInlama!UBeCopyFoonApprovedOMBNo.2070-0060UNITEDSTATESENVIRONMENTALPROTECTIONAGENCY401MStreet,S.W.WASHINGTON,D.C.20460PaperworkReductionActNotice:Thepublicreportingburdenforthiscollectionofinformationisestimatedtoaverage0.25hoursperresponseforregistrationactivitiesand0.25hoursperresponseforreregistrationandspecialreviewactivities,includingtimeforreadingtheinstructionsandcompletingthenecessaryfoons.Sendcommentsregardingtheburdenestimateoranyotheraspectofthiscollectionofinformation,includingsuggestionsforreducingtheburdento:Director,OPPEInformationManagementDivision(2137),U.S.EnvironmentalProtectionAgency,401MStreet,S.w.,Washington,DC20460.Donotsendtheformtothisaddress.DATAMATRIXDateJan.24,2011EPARea.No.lFileSvmbol87284-EIPaoe3of8Applicant'slRegistrant'sName&AddressProductWiUowoodPropiconazole,LLCWiUowoodTebuconazoleTechnical1600GardenValleyBlvd.Roseb,OR97471InnredientTebuconazol;tCASNo.;GuidelineReferenceNumberGuidelineStudu"'NameMRIDNumberSubmitterStatusNote830.7520ParticleSize,FiberLength,andDiameterNotRequired6Distribution830.7550PartitionCoefficient(n-octanol/water),Shake48143704WiUowoodPropiconazole,LLCPLFlaskMethod830.7560PartitionCoefficient(n-octanol/water),See830.7550GeneratorColumnMethod._/"830.7570PartitionCoefficient(n-octanollWater),EstimationSee830.7550830.7840WaterSolubility:ColumnElutionMethod;48143704WillowoodPropiconazole,LLCPLShakeFlaskMethod830.7860WaterSolubilitvGeneratorColumnMethodSee830.7840830.7950VaDorPressure48143704WiUowoodProoiconazole,LLCPL870.1100AcuteOralRatCite-AllPAY870.1200AcuteDermalToxicitv:RatCite-AllPAY870.1300AcuteInhalationToxicitv:RatCite-AllPAYSignatureNameanc!TitleOateAnnM.Tillman,ConsultantJan.24,2011EPAFonn8570-35(9-97)ElectronicandPaperversio/lSavaililble.SubmitonlyPilperverslOll.AgencyInternalUeeCopyUNITEDSTATESENVIRONMENTALPROTECTIONAGENCYFormApprovedOMBNo.I401MStreet,S.W.WASHINGTON,D.C.20460PaperworkReductionActThepublicreportingburdenforthiscollectionofinformationisestimatedtoaverage0.25hoursperresponseforregistrationIactivitiesand0.25hoursperresponseforreregistrationandspecialreviewactivities,includingtimeforreadingtheinstructionsandcompletingthenecessaryforms.Sendcommentsregardingtheburdenestimateoranyotheraspectofthiscollectionofinformation,includingsuggestionsforreducingtheburdento:Director,OPPEInformationManagementDivision(2137),U.S.EnvironmentalProtectionAgency,401MStreet,S.W.,Washington,DC20460.Donotsendtheformtothisaddress.DATAMATRIXDateJan.24,2.011EPAReg.No.iFileSymbol87284-EIPaae'iof8Applicant's/Registrant'sName&AddressProductWillowoodPropiconazole,LLCt600NWGardenValleyBlvd.WillowoodTebuconazoleTechnicalRoseburQ,OR97471IngredientTebuconazole(CASNo.107534..96-3)RererenceNumberGuideijneStudyNameMRIDNUmberSubmitterStatus870.2400PrimarYEveIrritation:RabbitCite-AllPAY870.2500PrimaryDermalIrritationPAY8702600DermalSensitizationPAYTebuconazoleGenericDataReauirements"j'WillowoodPropiconazole,LLCwillmaketothefollowingcompaniesontheTebuconazoledatasubmitterslistofMarch31,2010.AllGenericDataRequirementsBayerCropScienceLPPAYAllGenericDataRequirementsCite-AllFMCCorp.AgriculturalPAYProducts"groupAllGenericDataRequirementsBaverEnvironmentalSciencePAYAllGenericDataRequirementsCite-AllOsmoseInc.PAYAllGenericDataRequirementsBayerCorp.PAYAllGenericDataRequirementsCite-Allcerexoori,Inc.PAYAllGenericDalaR!l_quirementsCite-AllCheminovaNSPAYSignatureNameandTilleAnnM.Tillman,ConsultantJan.24,201tEPAForm8570-35(9·97)ElectronicandPaperversionsavailable.SubmitonlyPaperYllrsion.AgencyInternalUseCopyFormApprovedOMBNo.2070-0060IUNITEDSTATESENVIRONMENTALPROTECTIONAGENCY,401MStreet,S.W.WASHINGTON,D.C.20460PaperworkReductionActNotice:Thepublicreportingburdenforthiscollectionofinformationisestimatedtoaverage0.25hoursperresponseforregistrationactivitiesand0.25hoursperresponseforreregistrationandspecialreviewactivi1ies,includingtimeforreadingtheinstructionsandcompletingthenecessaryforms.Sendcommentsregardingtheburdenestimateoranyotheraspectofthiscollectionofinformation,includingsuggestionsforreducingtheburdento:Director,OPPEInformationManagementDivision(2137),U.S.EnVironmentalProtectionAgency,401MStreet,S.W.,Washington,DC20460.Donotsendtheformtothisaddress.DATAMATRIXDateJan.24,2011EPANo.lFileSymbol87284-EIPageSof8Applicant's/Registrant'sName&AddressProductWillowoodPropiconazole,LLC1600NWGardenValleyBlvd.WmowoodTebuconazoleTechnicalRoseburQ,OR97471IngredientTebuconazole(CASNo.107534-96-3)GuidelineReferenceNumberGuidelineStudvNameMRIDNumberSubmitterStatusNot.AllGenericDataReqUirementsCite-AllGustafsonLLCPAYAllGenericDataRequirementsCite-AllJ.J.MauQetCo.PAYAllGenericDataRequirementsCite-AllChemicalSpeCialties,Inc.PAYAllGenericDataReqUirementsCite-AllCPChemicalsInc.PAYAllGenericDataRequirementsCite-AllMakhteshimChemical WorksPAYLtd."./AllGenericDataRequ'lrementsCite-AIILovelandProducts,Inc.PAYAllGenericDataRequirementsCite-AllLanxessCorp.PAYAllGenericDataRequiremenlsCile-AIILuxemboum-PalmolInc.PAYAllGenericDataRequirementsCite-AllAlbaugh,Inc.PAYAllGenericDataRequirementsCite-AllBASFSparksLLCPAYAllGenericDataRequirementsCite-AllNufarmAmericasInc.PAYAllGenericDalaRequirementsCite-AllKop-CoatInc.PAYAllGenericDataRequirementsCite-AllSipcamAQroUSAInc.PAYAnGenericDataRequirementsCite-AllArchWoodPro1ectionInc.PAYSignatureNameafldTlIlII""'.AnnM.Tillman,ConsultantJan.24,20t1_......-EPAFonn8570·35(9·91)ElectronicandPaperveflllOflSavailable.SubmitonlyPaperversion.AgencyInternalUnCopyFormApprovedOMBNo.2070-0060UNITEDSTATESENVIRONMENTALPROTECTIONAGENCY401MStreet,S.W.WASHINGTON,D.C.20460PaperworkReductionActNotice:Thepublicreportingburdenforthiscollectionofinformationisestimatedtoaverage0.25hoursperresponseforregistraflonactivttiesand0.25hoursperresponseforreregistrationandspecialreviewactivities,includingtimeforreadingtheinstructionsandcompletingthenecessaryforms.Sendcommentsregardingtheburdenestimateoranyotheraspectofthiscollectionofinformation,includingsuggestionsforreducingtheburdento:Director,OPPEInformalionManagementDivision(2137),U.S.EnvironmenlalProtectionAgency,401MStreet,SW.,Washington,DC20460.DonotsendIheformtothisaddress.DATAMATRIXDateJan.24,Z011EPAReo.No.lFileSymbol87284-EIPage(o,f8Applicant's/Registrant'sName&AddressProductWillowoodPropiconazole,LLC1600NWGardenValleyBlvd.WillowoodTebuconazoleTechnicalRosebura.OR97471InClredientTebuconazole(CASNo.107534-96-3GuidelineReferenceNumberGuidelineStuclvNameMRIDNumberSubmitterStatusNoteAllGenericDataRequirementsCite-AllMakhteshimAganofNorthPAYAmerica,Inc.AllGenericDataRequirementsCite-AllArystaLifescienceNorthPAYAmericaInc.AllGenericDataRequirementsCtte-AIISprayDriftTaskForcePAYAllGenericDataRequirementsCite-AllCheminovaInc.PAYjAllGenertcDalaRequirementsCite-AllReparCorp.PAYAllGenericDataRequirementsCite-AllUnitedPhosphorusInc.PAYAllGenericDataRequirementsCite-AllSulphurMills,ltd.PAYAllGenericDalaRequirementsCite-AllOutdoorResidentialExposurePAYTaskForceAllGenericDataRequirementsCite-AllAgriculturalReentryTaskPAYForceAllGenericDataRequirementsCite-AllBayerAdvancedPAYAllGenericDataRequirementsCite-AllNissoTMLLCPAYSignatureNameandTilleDated..h.<£dLAnnM.Tillman,ConsultantJan.24,2011L...--_.-EPAFonn8570-35(9·97)Eleclronlc:andPaperversionsavailable.SubmilonlyPaperYetliion.Aglnc:yInternalUseCopYFormApprovedOMBNo.2070-0060UNITEDSTATESENVIRONMENTALPROTECTIONAGENCY401MStreet,S.W.WASHINGTON,D.C.20460PaperworkReductionActThepublicreportingburdenforthiscollectionof·rntormationisestimatedtoaverage0.25hoursperresponseforregistrationactivitiesand0.25hoursperresponseforreregistrationandspecialreviewactivities,includingtimeforreadingtheinstructionsandcomplelingthenecessaryforms.Sendcommentsregardingtheburdenestimateoranyotheraspectofthiscollectionofinformation,includingsuggestionsforreducingtheburdento:Director,OPPEInformationManagementDivision(2137),U.S.EnvironmentalProtectionAgency,401MStreet,S.w.,Washington,DC20460.Donotsendtheformtothisaddress.DATAMATRIXDateJan.24,2011EPAReQ.No.lFileSv.mbol87284-EIPage7of8Applicant's/Registrant'sName&AddressProductWillowoodPropiconazole,LLCWillowoodTebuconazoleTechnical1600NWGardenValleyBlvd.Roseburg,OR97471InaredientTebuconazoleCASNo.107534-96-3\GuidelineReferenceNumberGuidelineStudyNameMRIDNumberSubmitterStatusNoteAllGenericDataRequirementsCite-AllFIFRAEndangeredSpeciesPAYTaskForceLLCAllGenericDataRequirementsCite-AllPunjabChemicals&CropPAYProtectionAllGenericDataRequirementsCite-AllOsmoseNewZealandPAYAllGenericDataRequirementsCite-AllArchWoodProtection(NZ)PAY--""Ltd.AllGenericDataRequirementsCite-AllAgriculturalHandlersPAYExposureTaskForceAllGenericDataRequirementsCite-AllOsmoseUtilitiesServicesInc.PAYAllGenericDataRequirementsC.e-AIIArchTreatmentTechnologies,PAYInc.AllGenericDataRequirementsCite-AllU.S.TriazoleTaskForcePAYAllGenericDataRequirementsCite-AllGro-ProLLCPAYAllGenericDataRequirementsCite-AllRotamLtd.PAYAllGenericDataRequirementsCite-AllSourceDvnamicsLLCPAYSlgnalureNameandTHleDaleAnnM.Tillman,ConsultantJan.24,2011----------_.....---EPAFORn8570-35t9-97}ElectronicandPaperversionsavailable.SubmitonlyPaperversion.Ag.ncyIn1lm'"U••CopyFormApprovedOMBNo.2070·0060UNITEDSTATESENVIRONMENTALPROTECTIONAGENCY401MStreet.S.W.WASHINGTON,D.C.20460PaperworkReductionActNotice:ThepublicreportingburdenforthiscollectiOnofinformationisestimatedtoaverage0.25hoursperresponseforregistrationactivitiesand0.25hoursperresponseforreregistrationandspecialreviewactiVities,includingtimeforreadingtheinstructionsandcompletingthenecessaryforms.Sendcommentsregardingtheburdenestimateoranyotheraspectofthiscollectionofinformation,includingsuggestionsforreducingtheburdento:Director,QPPEInformationManagementDivision(2137),U.S.EnvironmentalProtectionAgency,401MStreet,S.W.,Washington,DC20460.Donotsendtheformtothisaddress.DATAMATRIXDateJan.24,2011.EPAReN.No.lFileSvmQoI87284·EIPaoeX'of8Applicant's/Registrant'sName&AddressProductWillowoodPropiconazole,LLCWillowoodTebuconazoleTechnical1600NWGardenValleyBlvd.Roseburo,OR97471Tebuconazole(CASNo.107534.96--3)-GuideUneReferenceNumberGuidelineStudvNameMRIDNumberSubmitterStatusNoteAllGenericDataRequirementsCite·AIIShardaWorldwideExportsPAYPvt.Ltd.AllGenericDataRenuirementsCite-AllRotamAarochemicalCo.Ltd.PAYiAllGenericDataReauirementsCite-AllJ.OliverProducts,LLCPAY,AllGenericDataRenuirementsCite·AIIShardaUSALLCPAYIAllGenericDataReauirementsCite-AllAmTideLLCPAYAllGenericDataRequirementsCite·AIIGenericEndangeredSpeciesPAYITaskForceAllGenericDataCite-AllPhibroWood,LLCPAYAllGenericDataRenuirementsCite-AllTrustchemCo.,Ltd.PAY,AllGenericDataReauirementsCite-AllBerkemDeveloomentPAYSignatureNameandTItleDateAnnM.Tillman,ConsultantJan.24,201tEPAForm8570-35(9-97)ElectronicandPaperversionsavailable.SubmitonlyPaperversion.AgencyInternaluseCOpy

### Endnotes for Data Matrix for Willowood Tebuconazole Technical

1 

### 830

. 1 650

_ These data are not required for the registration of a technical grade active ingredient

prodUct. See 830.1620 for production process information.

2 

### 830.6313

_ Willowood Propiqonazole, LLC does not package WiUowood Tebuconazole Technical in

metal containers, nor is Willowood Tebuconazole Technical expected to come into contact with metals

or metal ions during its storage or use. Therefore, a waiver from the requirement of these data is

requested. Willowood Tebuconazole Technical was found to be stClble at normal and elevated

temperatures.

3 

### 830.6315

_ Willowood Propiconazole, LLC requests a waiver from the requirement of this data

requirement since Wlflowood Tebuconazole Technical is a solid and is not expected to be flammable.

Please refer to the Confidential Statement of Formula for WHiowood Tebuconazole Technical.

4 

### 830.6316

_ Wiflowood Propiconazole, LLC requests a waiver from this data requirement because

tebuconazole does not have the chemical bonds or functional groups associated with explosive

chemicals. Please refer to the Confidential Statement of Formula for Willowood Tebuconazole

Technical.

5 

### 830 .6311, 830.6320

- Per PR Notice 92-5, storage stability and corrosion characteristics data are not

required to be submitted unless specifically requested by the Agency. Willowood Propiconazole, LLC

agrees to conduct this study if reqUired and requests that the study be made a condition of registration.

6 

### 8 30.6319,830.6321,830.1520

- Wlilowood Tebuconazole Technical is a solid and not an emulsifiable

concentrate and is not 

### to be diluted with petroleum solvents. Therefore, miscibifity data are not

required for this technical. Wilfowood Tebuconazole Technical is not to be used around electrical

equipment and data for dielectric breakdown constant are not required. Willowood Propiconazole, LLC

is seeking a waiver for particle size, fiber length and diameter distribution because WHfowood

Tebuconazole Technical is not water Insoluble nor is it a fibrous material.

7 

### 830.7100

_ Willowood Propiconazole, LLC requests a waiver from this data requirement because

WHiowood Tebuconazole Technical is a solid.

6 

### 830.7220

_ Wiflowood Tebuconazole Technical is a solid and bOiling point data are not required for

solids. Data for melting point are required for solids. See Guideline 830.7220.

9 

### 830

. 7 370

_ Willowood Propiconazole, LLC is seeking a waiver for this data requirement for WiRowood

Tebuconazole Technical**b~cause** 

### the product does not have any funct'lonal groups that would

dissociate.



### Page f 

### of 1

# I

Re: Willowood Tebuconazole Technical, 87284-E; Decision Number

D-436738 

# G:I

Mary Waller to; Ann Tillman Otf24/2011 

### 09:35 AM

Ann: The PRIA due date is 1/26/2011. I could finish 

### it tcxlay if you could pdf me a corrected data matrix

(both public and Agency internal copy). 

### t need the following changes:

On page 1, fill in the status column for 830.1700. I assume that the column should indicate "OWN".

On page 4, change the heading "Tebuconazole Product Specific and Generic Data Requirements" to

"Tebuconazole Generic Data 

### Requirements", and in the Guideline Reference Number column below the

header, write "All Generic Data Requirements" which I assume is your intent.

On page 5, correct the spelling of "SipcanmAgro" to read "SipcamAgro".

Mary L Waller

Product Manager 

### 21

Fungicide Branch

Reg'lstration Divis'lon

Office of Pesticide Programs

U.S. Environmental Protection Agency



### (703) 308-9354

waller.mary@epa,gov

Ann Tillman

From:

To:

Date:

Subject:

Mary, Mary, Can you let me know if this registration act...

Ann Tillman <Ann@PyxisRC.com>

Mary WalierfDCfUSEPA/US@EPA

01f24f20t 1 06:15 AM



### Willowood Tebuconazole Technical, 87284·E; Decision Number D·436738 01/24/2011 

### 06:15:04 AM

Can you let me know if this registration action is completed? I believe the PRIA date was Jan. 23. If

approved, would it be possible for you to email me the notice of registration? Thanks very much.

Ann

Ann 

### M. Tillman, Ph.D.

Pyxis Regulatory Consulting, Inc.

4110136'" Sf. 

### NW

Gig Harbor, WA 98332

Office 

### (253) 853-7369



### Fax (253) 853-5516

Emaif Ann@PyxisRC.comFormApprovedOMBNo.2070-0060UNITEDSTATESENVIRONMENTALPROTECTIONAGENCY401MStreet,S.W.WASHINGTON,D.C.20460PaperworkReductionActNotice:Thepublicreportingburdenforthiscollectionofinformationisestimatedtoaverage0.25hoursperresponseforregistrationactivitiesand0.25hoursperresponseforreregistrationandspecialreviewactivities,includingtimeforreadingtheinstructionsandcompletingthenecessaryforms.Sendcommentsregardingtheburdenestimateoranyotheraspectofthiscollectionofinformation,includingsuggestionsforreducingtheburdento:Director,OPPEInformationManagementDivision(2137),U.S.EnvironmentalProtectionAgency,401MStreet,S.W.,Washington,DC20460.Donotsendtheformto thisaddress.DATAMATRIXDateJune27,2010EPAReg.No.fFileSymbol87284-IPageIof8Applicant's/Registrant'sName&AddressProduct-WillowoodPropiconazole,LLCWillowoodTebuconazoleTechnical1600NWGardenValleyBlvd.RoseburQ,OR97471IngredientTebuconazo!e(CASNo.107534-96-3)GuidelineReferenceNumberGuide!ineStudyNameMRIDNumberSubmitterStatusNoteProductSoecificDataReauirements830.1550ProductIdentityandCompositionVolume1WillowoodPropiconazole,LLCOWN830.1600DescriptionofMaterialsUsedtoProducetheVolume1WillowoodPropiconazole,LLCOWNProduct830.1620DescriptionofProductionProcessVolume1WillowoodPropiconazole,LLCOWN830.1650DescriptionofFormulationProcessNotReQuired1830.1670DiscussionofFormationofImpuritiesVolume1WillowoodPropiconazole,LLCOWNPreliminaryAnalysisWlllowoodPropiconazole,LLC\(-COI.-{o(i::.'H(.b!I830.1700Volume2/(){{k830.1750CertifiedLimitsVolume1WillowoodPropiconazole,LLCOWN.830.1800EnforcementAnalyticalMethodVolume1WillowoodPropiconazole,LLCOWN830.6302Colpr..Volume3WillowoodPropiconazole,LLCOWN830.6303·.FJl«ysicalStateVolume3WillowoodPropiconazole,LLCOWN·"WillowoodProoiconazole,LLC830.6304·.Volume3OWN..830.6313StabilitytoNormalandElevatedTemperatures,Volume3WillowoodProp'lconazole,LLCOWNData-.--Metals,and:MetallonsVolume4OWNWaiver-..•NameandTilleOateSignature..... .•-.-..d..J,tJdL'·..,.AnnM.Tillman,ConsultantJune27,2010EPAForm8570-35(9-97)EleclronicandPaperversionsavailable.SubmitonlyPaperversion.AgencyInternalUsoCopyFormApprovedOMBNo.2070-0060UNITEDSTATESENVIRONMENTALPROTECTIONAGENCY401MStreet,S.W.WASHINGTON,D.C.20460PaperworkReductionActNotice:Thepublicreportingburdenforthiscollectionofinformationisestimatedtoaverage0.25hoursperresponseforregistrationactivitiesand0.25hoursperresponseforreregistrationandspecialreviewactivities,includingtimeforreadingtheinstructionsandcompletingthenecessaryforms.Sendcommentsregardingtheburdenestimateoranyotheraspectofthiscollectionofinformation,includingsuggestionsforreducingtheburdento:Director,OPPEInformationManagementDivision(2137),U.S.EnvironmentalProtectionAgency,401MStreet,S.W.,Washington,DC20460.Donotsendtheformtothisaddress.DATAMATRIXDateJune27.2010EPANo.fFileSvmbol87284-I8Applicant's/Registrant'sName&AddressProductWillowoodPropiconazole,LLC1600NWGardenValleyBlvd.WillowoodTebuconazoleTechnicalRoseburg,OR97471lnQredientTebuconazole(CASNo.107534-96-3)GuidelineReferenceNumberGuidelineStudyNameMRIDNumberSubmitterStatusNote830.6314Oxidation/Reduction:ChemicallncompatibilitvVolume3WillowoodPropiconazole,LLCOWN830.6315FlammabilityVolume4WillowoodPropiconazole,LLCOWNWaiver830.6316ExplodabililyVolume4WillowoodPropiconazole,LLCOWNWaiver4830.6317StoraqeStabilitvPRN92-55830.6319MiscibilityNotReQuired6830.6320CorrosionCharacteristicsPRN92_55830.6321DielectricBreakdownVoltaqeNotReauired6830.7000•pHVolume3WillowoodPropiconazole,LLCOWN830.7050UVNisibleAbsorptionVolume3WillowoodPropiconazole,LLCOWN830.7100ViscosityVolume4WillowoodPropiconazole,LLCOWNWaiver7830.7200·•Meliin-l"PclinUMeltinaRanaeVolume3WillowoodProoiconazole,LLCOWN· .RanqeNotRequired8830.7220-· .·.bsttsitYtl'{elativeDensity/BulkDensityWillowoodPropiconazole,LLC830.7300Volume3OWN830.7370DissociationConstantsinWaterVolume4WillowoodPropiconazole,LLCOWNWaiver-"•Signature....·NameandTitleDate....·a"JK;:JiJ.:>.•AnnM.Tillman,ConsultantJune27,2010...,EPAForm8570·35(9·97)ElectronicandPaperversionsavailable.SubmitonlyPaperversion.AgencyInternalUseCopyFormApprovedOMSNo.2070-0060UNITEDSTATESENVIRONMENTALPROTECTIONAGENCY401MStreet,S.W.WASHINGTON,D.C.20460PaperworkReductionActNotice:Thepublicreportingburdenforthis collectionofinformationisestimatedtoaverage0.25hoursperresponseforregistrationactivitiesand0.25hoursperresponseforreregistrationandspecialreviewactivities,includingtimeforreadingtheinstructionsandcompletingthenecessaryforms.Sendcommentsregardingtheburdenestimateoranyotheraspectofthiscollectionofinformation,includingsuggestionsforreducingtheburdento:Director,OPPEInformationManagementDivision(2137),U.S.EnvironmentalProtectionAgency,401MStreet,S.W.,Washington,DC20460.Donotsendtheformtothisaddress.DATAMATRIXDateJune27,2010EPAReo.No.lFileSvmbolIPao.gol8AppJicant's/Registrant'sName&AddressProductWillowoodPropiconazole,LLCWillowoodTebuconazoleTechnical1600t-NVGardenValleyBlvd.Roseburq,OR97471InaredientTebuconazole(CASNo.107534-96-3)GuidelineReferenceNumberGuide6neStud"NameMRIONumberSubmitterStatusNote830.7520ParticleSize,FiberLength,andDiameterNotRequ[red6Distribution830.7550PartitionCoefficientShakeVolume4WillowoodPropiconazole,LLCPLFlaskMethod830.7560PartitionCoefficient(n-octanollwater),See830.7550GeneratorColumnMethod830.7570PartitionCoefficient(n-octanol/water),See830.7550EstimationbvLiauidChromatoaraoh'v830.7840WaterSolubility:ColumnElutionMethod;Volume4WillowoodPropiconazole,LLCPLShakeFlaskMethod830.7860WaterSolubilitv,GeneratorColumnMethodSee830.7840830.7950Vaoor:!?:cssureVolume4WillowoodProoiconazole,LLCPL....--....-870.1100-.'AGlite-0r;i;1Toxicitv:RatCite-AllPAY870.1200AcuteDermalToxicitv:RatCite-AllPAY870.1300....InhalationToxicitv:RatCite-AllPAY....,NameandTilleOateSignature, ,....,',.".AnnM.Tillman,ConsultantJune27,2010EPAForm8570-35(9-97)EleclronicandPaperversionsavailable.SubmitonlyPaperversion.AgencyInternalUseCopyFormApprovedOMSNo.2070-0060UNITEDSTATESENVIRONMENTALPROTECTIONAGENCY401MStreet,S.W.WASHINGTON,D.C.20460PaperworkReductionActNotice:Thepublicreporting burdenforthiscollectionofinformationisestimatedtoaverage0.25hoursperresponseforregistrationactivitiesand0.25hoursperresponseforreregistrationandspecialreviewactivities,includingtimeforreadingtheinstructionsandcompletingthenecessaryforms.Sendcommentsregardingtheburdenestimateoranyotheraspectofthiscollectionofinformation,includingsuggestionsforreducingtheburdento:Director,OPPEInformationManagementDivision(2137),U.S.EnvironmentalProtectionAgency,401MStreet,S.W.,Washington,DC20460.Donotsendtheformtothisaddress.DATAMATRIXDateJune27,2010EPAReo.No.lFileSvmbol87284-IPaae4af8Applicant's/Registrant'sName&AddressProduct.--"WillowoodPropiconazole,LLC1600NWGardenValleyBlvd.WillowoodTebuconazoleTechnicalRoseburq,OR97471InnredientTebuconazole(CASNo.107534-96-3"\GuidelineReferenceNumberGuidelineSlu-;-NameMRIDNumberSubmitterStatusNote870.2400PrimarvEveIrritation:RabbitCite-AllPAY870.2500PrimarvDermalIrritationCite-AllPAY870.2600DermalSensitizationPAYTebuconazoleGenericDataReauirementsWillowoodPropiconazole,LLCwillmakeoffers-to-paytothefollowingcompaniesontheTebuconazoledatasubmitterslistofMarch31,2010.Cite-AllBaverCrooScienceLPPAYCite-AllFMCCorp.AgriculturalPAY.Products'arouDCite-All"•BaverEnvironmentalSciencePAY""""Cite-AllOsmoseInc.PAY"""."" "...-BaverCorn."..."Cite-AllPAYCite-AllCerexaari,Inc.PAY-----Cite-AllCheminovaAlSPAY."""-""DateSignalure"-"""NameandTitle""""-.ti.j,<jdL'--"AnnM.Tillman,ConsultantJune27,2010-"""EPAFOnTl8570-35{9-97)ElectronicandPaperversionsavailable.SubmitonlyPaperversion.AgoncylnlornalUseCopyFormApprovedOMBNo.2070-0060UNITEDSTATESENVIRONMENTALPROTECTIONAGENCY401MStreet,S.W.WASHINGTON,D.C,20460PaperworkReductionActNotice:Thepublicreportingforthiscollectionofinformationisestimatedtoaverage0.25hoursperresponseforregistrationactivitiesand0.25hoursperresponseforreregistrationandspecialreviewactivities,includingtimeforreadingtheinstructionsandcompletingthenecessaryforms.Sendcommentsregardingtheburdenestimateoranyotheraspectofthiscollectionofinformation,includingsuggestionsforreducingtheburdento:Director,OPPEInformationManagementDivision(2137),U.S.EnvironmentalProtectionAgency,401MStreet,S.W.,Washington,DC20460.Donotsendtheformtothisaddress.DATAMATRIXDateJune27,2010EPARea.No.lFileSvmbol87284-IPaoeSof8Applicant'siRegistrant'sName&AddressProductWillowoodPropiconazole,LLC1600NWGardenValleyBlVd.WillowoodTebuconazoleTechnicalRoseburn,OR97471InoredientTebucanazol;7CASNo.107534-96-3)GuidelineReferenceNumberGuidelineStudvNameMRIDNumberSubmitterStatusNoteCite-AllGustafsonLLCPAYCite-AllJ.J.MauaetCo.PAYCite-AllChemicalSoecialties,Inc.PAYCite-AllCPChemicalsInc.PAYCite-AllMakhteshimChemicalWorksPAYLId.Cite-AllLovelandProducts,Inc.PAYCite-AllLanxessCoro.PAYCite-AllLuxemboura-PalmolInc.PAYCite-AllAlbaunh,Inc.PAY-.-,Cite-AllBASFSoarksLLCPAY-..,.-Cite-AllNufarmAmericasInc.PAY-c·_--.-.Koo-CoatInc.PAYCite-AllCite-AllSinca'ttmAaroUSAInc.PAY,/"Cite-AllArchWoodProtectionInc.PAY.--•.NameandTitleOateSignature--.---4..'u:;Ji---:--..--.AnnM.Tillman,ConsultantJune27,2010EPAFonn8570-35{9-97)ElectronicandPaperversionsavailable.SubmilonlyPaperversion.AgencyInternalUseCopyFormApprovedOMBNo.2070-0060UNITEDSTATESENVIRONMENTALPROTECTIONAGENCY401MStreet,S.W.WASHINGTON,D.C.20460PaperworkReductionActNotice:Thepublicreportingburdenforthiscollectionofinformationisestimatedtoaverage0.25hoursperresponseforregistrationactivitiesand0.25hoursperresponseforreregistrationandspecialreviewactivities,includingtimeforreadingtheinstructionsandcompletingthenecessaryforms.Sendcommentsregardingtheburdenestimateoranyotheraspectofthiscollectionofinformation,includingsuggestionsforreducingtheburdento:Director,OPPEInformationManagementDivision(2137),U.S.EnvironmentalProtectionAgency,401MStreet,S.W.,Washington,DC20460.Donotsendtheformtothisaddress.DATAMATRIXDateJune27,2010EPAReq.No.lFileSymbol87284-IPaoe",of8Applicant's/Registrant'sName&AddressProduct--WillowoodPropiconazole,LLCWillowoodTebuconazoleTechnical1600NWGardenValleyBlvd.Roseburg,OR97471InQredientTebuconazole(CASNo.107534-96-3)GuidelineReferenceNumberGuidelineStudyNameMRIDNumberSubmitterStatusNoteCite-AllMakhteshimAganofNorthPAYAmerica,Inc.Cite-AllArystaUfescienceNorthPAYAmericaInc.Cite-AllSprayDriftTaskForcePAYCite-AllCheminovaInc.PAYCite-AllReparCorp.PAYCite-AUUnitedPhosphorusInc.PAYCite-AUSulphurMills,Ltd.PAY--"Cite-AUOutdoorResidentialExposurePAYTaskForce".-"".Cite-AnAgriculturalReentryTaskPAYc."-,.""---Force"--Cite-AUBayerAdvancedPAYCite"AUNissoTMLLCPAY-..,..""---Signature--"-NameandTilleDate-t2..J.NdiJ"'-'-"AnnM.Tillman,ConsultantJune27,2010".".._....EPAFonn8570-35(9-97)ElectronicandPaperversionsavailable.SubmitonlyPaperverslon.AgencyInternalUseCopyFormApprovedOMBNo.2070-0060UNITEDSTATESENVIRONMENTALPROTECTIONAGENCY401MStreet,S.W.WASHINGTON,D.C.20460PaperworkReductionActNotice:Thepublicreportingburdenforthiscollectionofinformationisestimatedtoaverage0.25hoursperresponseforregistrationactivitiesand0.25hoursperresponseforreregistrationandspecialreviewactivities,includingtimeforreadingtheinstructionsandcompletingthenecessaryforms.Sendcommentsregardingtheburdenestimateoranyotheraspectofthiscollectionofinformation,includingsuggestionsforreducingtheburdento:Director,OPPEInformationManagementDivision(2137),U.S.EnvironmentalProtectionAgency,401MStreet,S.W.,Washington,DC20460.Donotsendtheformtothisaddress.DATAMATRIXDateJune27,2010EPAReq.No./FileSymbol87284-IPaoe!of8Applicant's/Registrant'sName&AddressProduct-WiUowoodPropiconazole,LLC1600NWGardenValleyBlvd.WiUowoodTebuconazoleTechnicalRosebura,OR97471InnredientTebuconazoletCASNo.107534-96-3\GuidelineReferenceNumberGuidelineStudyNameMRIONumberSubmitterStatusNoteCite-AllF!FRAEndangeredSpeciesPAYTaskForceLLCCite-AllPunjabChemicals&CropPAYProtectionCite-AllOsmose NewZealandPAYCite-AllArchWoodProtection(NZ)PAYLtd.Cite-AllAgricultura!Hand!ersPAYEXDosureTaskForceCite-AllOsmoseUtilitiesServicesInc.PAY..•Cite-AllArchTreatmentTechnologies,PAY··Inc.·0v...•Cite-AllU.S.TriazoleTaskForcePAY··....,·· ......'-Cite-AllGro-ProLLCPAYCite-AllRotamLtd.PAY.......Cite-AllSourceDvnamicsLLCPAY· ...· .·..Signature·.·...NameandTitleDate·...·....·....AnnM.Tillman,ConsultantJune27,2010EPAFonn8570·35(9·97)ElectronicandPaperversionsavailable.SubmitonlyPaperversion.AgencyInternalUseCopyFormApprovedOMBNo.UNITEDSTATESENVIRONMENTALPROTECTIONAGENCY401MStreet,S.W.WASHINGTON,D.C.20460PaperworkReductionActNotice:Thepublicreportingburdenforthiscollectionofinformationisestimatedtoaverage0.25hoursperresponseforregistrationactivitiesand0.25hoursperresponseforreregistrationandspecialreviewactivities,includingtimeforreadingtheinstructionsandcompletingthenecessaryforms.Sendcommentsregardingtheburdenestimateoranyotheraspectofthiscollectionofinformation,includingsuggestionsforreducingtheburdento:Director,OPPEInformationManagementDivision(2137),U.S.EnvironmentalProtectionAgency,401MStreet,S.W.,Washington,DC20460.Donotsendtheformtothisaddress.DATAMATRIXDateJune27,2010EPARea.No.lFileSymbol87284-IPaceBofSApplicant's/Registrant'sName&AddressProduct.WillowoodPropiconazole,LLC1600NWGardenValleyBlvd.WillowoodTebuconazoleTechnicalRoseburo,OR97471lnaredientTebuconazol;!CASNo.GuidelineReferenceNumberGuidelineStudyNameMRIDNumberSubmitterStatusNoteShardaWorldwideExportsPAYPvt.Ltd.Cite-AllRotamAarochemicalCo.Ltd.PAYCtte-AHJ.OliverProducts,LLCPAYCite-AllShardaUSALLCPAYCite-AnAmTideLLCPAYCite-AllGenericEndangeredSpeciesPAYTaskForcePhibroWood,LLCPAY-TrustchemCo.,Ltd.PAYBerkemDeveloomentPAY.-Signature.·,,NameandTitleOate,......!L)z,<JJL,·,,."AnnM.Tillman,ConsultantJune27,2010.·,,,....,,."EPAFonn8570-35(9-97)ElectronicandPaperversionsavailable.SubmitonlyPaperversion.AgencyInternalUseCopy

## Endnotes for Data Matrix for Willowood Tebuconazole Technical

1 

### 830.1650**~** These data are not required for the registration of a technical grade active ingredient

product. See 830.1620 for production process information.

2 

### 830.6313**~** 

### Willowood Propiconazole, LLC does not package Willowood Tebuconazole Technical in

metal containers, nor is Willowood Tebuconazole Technical expected to come into contact with metals



### or metal ions during its 

### storage or use. Therefore, a waiver from the requirement of these data is

requested. WHlowood Tebuconazole Technical was found to be stable at normal and elevated

temperatures.

3 

### 830.6315

_ Willowood Propiconazole, LLC requests a waiver from the requirement of this data

requirement since Willowood Tebuconazole Technical is a solid and is not expected to be flammable,

Please refer to the Confidential Statement of Formula for Willowood Tebuconazole Technical.

4 

### 830.6316

_ Wllowood Propiconazole, LLC requests a waiver from this data requirement because

tebuconazole does not have the chemical bonds or functional groups associated with explosive

chemicals. Please refer to the Confidential Statement of Formula for Willowood Tebuconazole

Technical.



### s 830.6317, 830.6320

_ Per 

### PR Notice 

### 92-5\ storage stability and corrosion characteristics data are not

required to be submitted unless specifically requested by the Agency. Wllowood Propiconazole, LLC

agrees to conduct this study if required and requests that the study be made a condition of registration.



### 6830.6319,830.6321,830.7520

- Willowood Tebuconazole Technical is a solid and not an emulsifiable

concentrate and is not to be diluted with petroleum solvents. Therefore, miscibility data are not

required for this technical. Willowood Tebuconazole Technical Is not to be used around electrical

equipment and data for dielectric breakdown constant are not required. Willowood Propiconazole\ LLC

is seeking a waiver for particle size, fiber length and diameter distribution because Willowood

Tebuconazole Technical is not water insoluble nor is it a fibrous material.

7 

### 830.7100

_ Willowood Propiconazole, LLC requests a waiver from this data requirement because

Willowood Tebuconazole Technical is a solid.

a 

### 830.7220

_ Willowood Tebuconazole Technical is a solid and boiling point data are not required for

solids. Data for melting point are required for solids. See Guideline 

### 830.7220.

9830.7370

_ Willowood Propiconazole, LLC is seeking a waiver for this data requirement for Wlilowood

Tebuconazole Technical because the product does not have any functional groups that would

dissociate.



### "



## , > 

## ",,.> •.

> ,



## , ,

, "



## , 

## "

, , ,

,

, 

### " "



## , , 

# . ,

o , , ,



### Page 

### 1 of 1

# I

f UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, D.C. 20460

December 8, 2010

MEMORANDUM OFFICE OF CHEMICAL SAFETY AND

POLLUTION PREVENTION



## Subject: Name of Pesticide Product:

EPA Reg. No. 

## IFile Symbol: WILLOWOOD 

### TEBUCONAZOLE TECHNICAL



## 87284-E

DP Barcode: D381103

Decision No.: 436738

Action Code: 310

PC Code: 128997 Tebuconazole

From:

To:

Registrant: Masih Hashim, Toxicologist

Technical Review Branch

Registration Division (7505P)

Tracy KeigwinIMary Waller, RM Team 21

Fungicide Branch

Registration Division (7505P)

Willwood Propiconazole, LLC

FORMULATION FROM LABEL:

Active Ingredient(s):



## 128997 Tebuconazole CAS No. 107534-96-3

Other Ingredient(s):

ACTION REQUESTED:

# if-{;~ 

# ,**tVlt~**

%bywt

98.5

1.5



## Total: 100%

To determine 

## if the cited and the proposed products are similar in toxicity.

Page I of2

### RECOMMENDATIONS: The cited and the proposed products (#81598-2 and #87284-E) are

substantially similar in toxicity (cite-all method). IRE has no objection to bridging data between



## them.

The acute toxicity profile for Willowood Tebuconazole, EPA File Symbol 87284-E is as follows:

Acute oral toxicity III 

## cited EPA Reg. No. 81598-2

Acute dermal toxicity 

## IV cited EPA Reg. No. 81598-2

Acute inhalation toxicity 

## IV cited EPA Reg. No. 81598-2

Primary eye irritation 

## IV cited EPA Reg. No. 81598-2

Primary dermal irritation 

## IV cited EPA Reg. No. 81598-2



## DelTIlal sensitization neg. cited EPA Reg. No. 81598-2

The Tox profile for EPA File Symbol 87284-E is as follows;

PRODUCT 10 

### #: 087284-00002

PRODUCT NAME: WILLOWOOD TEBUCONAZOLE TECHNICAL

PRECAUTIONARY STATEMENTS

SIGNAL WORD: CAUTION



### Hazards to Humans and Domestic Animals:

Harmful 

### jf swallowed. Wash thoroughly with soap and water after handling and before eating, drinking,

chewing gum, or using tobacco or using toilet.



### First Aid:

If 

## swallowed:

-Call a poison contro! center or doctor immediate!y for treatment advice.

-Have person sip a g!ass of water if ab!e to swallow.

-Do not induce vomiting un!ess to!d to by a poison contro! center or doctor.

-Do not give anything to an unconsdous person.

Page2of2

### DATA EVALUATION RECORD

TEBUCONAZOLE

(Willowood Tebuconazole Technical)

STUDY TYPES: Product Identity and Composition (OPPTS 830.1550)

Primary Reviewer: 

### Description of Materials Used to Produce the Product (OPPTS 830.1600)

Description of Production Process (830.1620)

Discussion of FormatioD ofImpurities (OPPTS 830.1670)

Preliminary Analysis (OPPTS 830.1700)

Certified Limits (OPPTS 830.1750)

Enforcement Analytical Method (OPPTS 830.1800)

Physical and Cbemical Characteristics (OPPTS 830.6302-830.7950)

MRIDs 481437-01 througb 480347-04

Prepared for

Registration Division

Office of Pesticide Programs

U.S. Environmental Protection Agency

One Potomac Yard

2777 South Crystal Drive

Arlington, VA 22202

Prepared by

Toxicology and Hazard Assessment Group

Environmental Sciences Division

Oak Ridge National Laboratory



### Oak Ridge, TN 37831

Task Order No. 

### 1-10

Thomas C. 

### Marshall, Ph.D., D.A.B.T.

Secondary Reviewers:

Eric B. Lewis, M.S. Signature:

Date:

Robert H. Ross, M.S., Group Leader

Quality Assurance:

Kimberly G. Slusher. M.S.



## Disclaimer

This review may have been altered subsequent to the contractor's signatures above.

Oak Ridge National Laboratory managed and operated by UT-Battelle, LLC., for the U.S. Department of Energy

under Contract No. DE-AC05-000R22725.

# FEE

BARCODE: 0381101; Reg. No./FILE 

### SYMBOL No. :**87284~E;** 

### PRODUCT: Willowood Tebuconazole



### Technical

Date: November 30, 2010

SUBJECT:

FROM:



### TO: FEE. Product Chemistry Review of Willa wood Tebuconazole Technical TGAI/MUP



### Shyam Mathur

Product chemistry Team Leader

Technical Review Branch 

### I RD (750SP)

Tracy Keigwin 

### I Mary Waller, RM 21



### Fungicide Branch I 

### RD (750SP)

DP BARCODE: 381101



### DECISION No.: 436738

Registration Number 

### I File Symbol No.: 87284-E

PRODUCT NAME: Willowood Tebuconazole Technical

PCC: 128997



### REGISTRANT: Willowood Propiconazole, LLC

USE: Herbicide.

FOOD USE: Yes 

## [XI No [ [

MRID Numbers: 481437-01 through 481437-04

INTRODUCTION:

The registrant is seeking a new product registration for a product that is substantially similar to an existing

product (Rotam Tebucanazole Technical WITH Reg. No. 81598-2). The new product, Willowood

Tebuconazole Technical, is for manufacturing use only, and the registrant is using the "Cite-All" method of

data support. A basic formulation using a four-step process at one location is proposed. The product is

manufactured by Jiangsu Sevencontinent Green Chemical Co., Ltd., Jiangsu, PR of China. Tebuconazole

is a triazole herbicide used on a variety of crops including cereals, corn, peanuts, pecans, vegetable

crops, pome fruit, stone fruit, and on turf and ornamentals, The Oak Ridge National Laboratory, Oak

Ridge, TN performed the primary review on the product. TRB has been asked the acceptance of the

proposed basic CSF (dated 06-04-10) and the supporting product chemistry data. TRB has been also

asked to determine the similarity of the proposed product to the cited product.

SUMMARY OF FINDINGS:

1. The registrant submitted a Confidential Statement of Formula (CSF) for the basic formulation (June 4,

2010). The product chemistry data submitted corresponding to guideline reference 830.1550 (product

identity 

### & composition) and 830.1750 (certified limits) satisfy the data requirements of 40CFR§158.155

and 158.175 respectively [MRID No. 481437-01].

2. The product chemistry data submitted corresponding to guideline reference 830.1600 (description of

material used to produce the product) satisfy the data requirements of 40CFR§ 158.160 [MRID No.

481437-01 [.

3. The product chemistry data submitted corresponding to guideline reference 830.1620 (description of

production process) satisfy the data requirements for 40CFR§158.162 [MRID No. 481437-01].



### 2

### BARCODE: 0381101; Reg. No./FILE 

### SYMBOL No.:**87284~E;** 

### PRODUCT: Willowood Tebuconazote

Technical

4. The product chemistry data submitted corresponding to guideline reference 830.1670 (discussion of

the formation of impurities) satlsfy the data requirements for 40CFR§158.167 [MRIO No.**481437~01** 

### [. No

impurity is of toxicological concern.

5. The data submitted corresponding to the guideline reference 830.1700 (preliminary analysis) supports

the claims on the CSF, and the submitted data satisfy the data requirements of 40CFR§158.170



### [MRID No. 481437-02[.

6. The data submitted corresponding to the guideline reference 830.1800 (enforcement analytical

method) satisfy the data requirements of 40CFR§158.180 [MRlD No. 481437-021. The enforcement

analyflcal method is gas chromatography with MS detection.

7. The data submitted corresponding to guidelines 830 Series Subgroup B (physical-chemical properties)

satisfy the data requirements of 40CFR§158.190 except that corrosion characteristics and storage

stability were not addressed [MRIO No's 481437·03 and 481437-04].

8. The registrant has requested waivers for the fo!!owing guidelines: 830.6313, 830.6315, 830.6316,

830.6317,830.6319, 830.6320, 830.6321, 830.7100, 830.7220, and 830.7520 with proper justificalions.

9. The registrant has cited the literature data for the guidelines: 830.7550-7570 (Ko/w), 830.7840-7860

(water solubility) and 830.7950 (vapor pressure).

CONCLUSIONS:

1). The product chemistry data submitted for guideline 830 Series group A are acceptable.

2). The proposed CSF for the basic formulation (dated June 4, 2010) is acceptable.

3). The product chemistry data submitted & 

### cited for group B (physical·chemical properties) are

acceptable except for the guidelines 830.6317(storage stability) and 830.6320 (corrosion characteristics)

studies. The registrant must conduct one year study with observations documented at 0, 3, 6, 9 and 12

month intervals.

4). Based on justlfications provided, the Agency has no objection in granting waivers for the guidelines:



### 830.6313,830.6315,830.6316,830.6317, 830.6319, 830.6320, 830.6321, 830.7100, 830.7220, and

830.7520.

5). The proposed product with File Symbol No. 87284-E was determined to be substantia!!y similar to the

cited product with Reg. No.**81598~2** 

### from the product chemistry point of view.

J

### BARCODE: 0381101; Reg. No./FILE SYMBOL No. :**87284~E;** 

### PRODUCT: Wi!lowood Tebuconazole

Technical

830.1550: Product identity & 

### Composition: (MRIO No. 481437-01)

Common Name: Tebuconazole

Chemica! name (CAS): (±)-a-[2-(4-chloropheny!)ethy!J- a**~(1, 1~dimethy!ethyl)~1~H-1**  

### ,2,4-triazole-1-ethanol

(I 

### U PAC): (RS) 1-p-chlorophenyl-4, 4-dimethyl-3-(1 

### H-1**,2,4~triazol-1·-y!methyl)pentan-3-ol**



### CAS No.: 107534-96-3

PC Code No.: 128997

Molecular Weight: 307.8

Structural formula:

4

### BARCODE: 0381101; 

### Reg. No./FILE SYMBOL No. : 87284-E: 

### PRODUCT: Willowood Tebuconazole

Technical

Table I. Manufacturing and Impurity Data forWillowood Tebuconazole Technical TGAlfMUP



# II Reguirement 

# IIMRID

830.1550 481437-0f

Product Identity and**compos~ion**

8301600 Description of materials used to 481437-0f

produce the product

48t437-01

830.1620 Description of production

process

481437-0f

830.1670 Discussion of formation of

impurities

481437-02

830.t700 Preliminary analysis

830.1750 Certified limits 481437-02

830.t800 Enforcement analytical method 48t437-02 

# II Status

A



### A

A

A

A

A

A 

# II Details and lor Deficiency

The percent AI for the basic (98.5) formulation

is supported by a 5 batch analysis. Impurities

are listed on the CSF. The percent AI for the

basic formulation agrees with the percent AI 

## I given on the product label.

The description and composition of starting

materials was provided.

The product is produced in a four-step batch

process. and details were provided.

A discussion of the origin and formation of

impurities was provided.

Five batches of product were analyzed and

results supported the CSF.

The Certified limits listed on the CSF are

supported by a 5 batch analysis of the basic

formulation.

GCfMS was used to determine the content of

AI. The method was validated for precision,

linearity, and accuracy.

A 

### = Acceptable; N = Unacceptable (see D:ficiency); NfA = Not Applicable; G = Data gap; I 

### = In progress or need upgrade; U

'" UPQrade (additional information required)



### 5

### BARCODE: D381101; 

### Reg. No./FILE SYMBOL No.: 87284-E; 

### PRODUCT: Willowood Tebuconazole

Technical

830 Series Subqroup 8 (Physical-Chemical Properties)

Table 2: Phvsical and Chemical Properties of Willowood Tebuconazole Technical TGAflMUP

GlN Requirement MRID Status Result or Deficiency

830.6302 Color 481437-03 A White

830.6303 Physical state 481437.(13 A Solid granular powder

830.6304 Odor 481437-03 A Sulfur-like

830.6313 Stabimy to normal and 481437-03 A Stable to ambient and elevated {54°C}

elevated temperatures, temperatures for 14 days. Compatible with CO 2 metals, and metal ions water, zinc powder, gasoline, and bleach.

W Waiver requested for metal ions since product is not

stored or used in metal containers.

830.63t4 Oxidationfreduction: 481437-03 A Compatible with CO

2 water, zinc powder, gasoline,

chemical incompatibility and bleach.

830.6315 Flammability 481437-03 W Solid; contains no flammable components

830.6316 Explodability 481437-04 W Stable; does not contain any structurally active

components

830.6317 Storage stability 481437-04 G Will conduct if requested

830.63t9 Miscibility 481437-03 NfA Not an end-use product

830.6320 Corrosion characteristics 481437-04 G Will conduct if requested

830.7000 pH 481437-03 A 7.28 at 25°C

830.7050 UVNisibJe absorption 481437-03 A Wavelength; molar absorption:

Methanol: E :: 375643

Acid: E:: 393436

Base: E:: 431001

830.7fOO Viscosity 481437-03 NfA Solid

830.7200 Melting point 481437-03 A 96.8

- 98.5 °c

830-1220 Boiling point 481437-03 NfA Solid

830.7300 Density 481437-03 A Pour: 0.577 gfmL

Tap: 0.681 gtmL

830.7370 Dissociation constants in 481437-03 W No functional groups available to dissociate

water (DC)

830.7550 Partition coefficient 481437-03 A Log p:: 3.7 {20'C} (Tomlin, ''The Pesticide Manual",

13'" Edition, p. 924, BCPC Publications, Hampshire,

2003)



### 6

### BARCODE: 0381101; Reg. No. IFILE SYMBOL No. : 87284-E; PRODUCT: Willowood Tebuconazole

Technical

Table 2: Physical and Chemical Properties of Willowood Tebuconazole Technical TGAUMUP

GLN Requirement MRID Status Resultor Deficiency

830.7840 Water solubility 481437-03 

### A 36 mg/L (pH 5-9, 20°C) (Tomlin, "The Pesticide

Manual", 13"' Edition, p. 924, BCPC Publications,

Hampshire, 2003)

830.7950 Vapor pressure 481437-04 

### A 1.7 x 10. 3 mPa (20'C). (Tomlin, "The Pesticide

Manual",**131~Edition,** p. 924, BCPC Publications,

Hampshire, 20031

A 

### = Acceptable; N 

### = Unacceptable (see Deficiency); N/A 

### = Not Applicable; G 

### = Data gap; I = In progress or need upgrade; U = Upgrade (additional information required); W 

### = waivers



### 830.1800. Enforcement of analytical method: The enforcement analytical method to determine the

content of active ingredient is gas chromatography with mass spectrometry detection (GCfMS). The

method was validated for precision and sample chromatograms were provided. The registrant provided

the following details in MRID 481437-02:



### 7

### BARCODE: 0381101; Reg. No. IFILE SYMBOL No. :**87284~E;** 

### PRODUCT: Willowood Tebuconazole

Technical

The test method used In the present study Is based on Gas Chromatography with MS detection,

The method is fully described below, as It was applied.



## 1. Principle.

Samples are dissolved In acetone and determined 

## by**GC~MS.** 

### Quantification is performed by external

callbtation



## 2. Reagents

Acetone: GC grade



## 3. Apparatus

GC system consisting in

HP 6S90A Series gas chromatograph system (Agllent)

HP 5973N Mass Spectrometer (Agilent)

HP 7683 automatic liquid sampler (Agilent)



## 4. Preparation of calibration solutions for COP, BPC and CBPC

Weigh (to the nearest 0,1 mg) approximately 50 mg of reference Item into a volumetric flask (50 ml).

Add acetone, cap the flask and sonicate to dissolve the compound, Allow to cool to rool,'**t~,r,~arature.** 

### Adjust to volume with acetone. Dilute a!!quots of this stock solution with acetone to obttlin &oli.ltions at

concentrations suitable for the working range.



## 5. Preparation oftest Item solutions

Weigh (to the nearest 0.1 mg) an aliquot of the test item (100 mg) Into a flask (50 ml). Add by pipette

25,0 ml of acetone. Cap the flask and sonicate to dissolve the analyte, Allow to cool to room

temperature,



### 8

### BARCODE: 0381101; Reg. No. IFILE SYMBOL No. : 87284-E; PRODUCT: Willowood Tebuconazole

Technical



## 6. Analytical conditions

The mass spectrum was recorded on an 

### AGiLENT 5973N mass spectrometer coupled to a gas

chromatograph.

Sample Introduction was performed by gas chromatography using the following conditlons :

Column HP-5 MS (Agilent code HP 19091J-433), 30 m length, 250 IJm internal diameter,



### 0.25 pm film thickness

Inlet: Split 

## i splitless (splitless mode) at 200 GC

Temperature: initial temperature: 70 ·C, initial time 2 min

Ramp to 170·C at 25 GClmin

Ramp to 220**~C** 

### at 3 ·C/mln

Ramp to 260 GC at 4 GCimin

Ramp to 270 CC at 6 "Cimin

Ramp to 300 GC at 8 ·Cimin

Carrier gas: Helium at 0.7 mllmn

MS Transfer line heater

Ionisation was perlormed by Electron Impact.



## 8. Calculation

Plot the amount of analyte injected versus peak area obtained for the analyte in the calibration

solutions. Calaulale Ihe regression function by least square 

### fit:



## C, (l'g/mL) =ax(peak area) +b

a: slope of calibration function



### b: intercept of calibration function**C~** 

### : concentration of analyte injected in the 

### GC system (lJgimL)

The analyte content in the test item is then calculated as follows:



### [ane/yte] :



### C

a :



### V:

d:



### W: 

## [anaryle 

# 1 (g / kg)

analyte content in the test item (gfkg)

concentratlon of analyte injected in the HPLC system (lJglmL)

final volume (mL)

dilution factor

mass of sample taken (mg)



### 9

### BARCODE: 0381101; Reg. No./FILE SYMBOL No. : 87284-E; PRODUCT: Willowood Tebuconazole

Technical

CONFIDENTIAL APPENDIX

Chemical (±)-a'12-(4- Reg"lslralion No. 87284-XXX DP Barcode D381101

chlorophenyl)elhyJ]-a-(1,1-

dimelhylelhyl)-1-H-1.2,4-

lriazole-1-elhanol

CB None provided Producl Type herbicide Tesl Subslance Tebuconazole

Number TGAlIMUP

Group A-GLNS 830.1550, 830.1600, 830.1620, 830.1650, 830.1670, 830.1700, 830.1750, & 830.1800: Compos ilion (CSF),

Impurities, Preliminary analysis, and Analytical Me1hods.



### 830.1600-1620: Description of materials used to produce the product and description of the produclion

process: (MRID No. 481437-01)

### BARCODE: D381101; Reg. No./FILE SYMBOL No.;**87284~E:** 

### PRODUCT; Willowood Tebuconazole

Technical

CONFIDENTIAL APPENDIX

18

### BARCODE: D381101; Reg. No./FILE SYMBOL No.:**87284~E;** 

### PRODUCT: Willowood Tebuconazole

Technical

CONFIDENTIAL APPENDIX

19

### BARCODE: 0381101; Reg. No./FILE SYMBOL No.: 87284-E: PRODUCT: Willowood Tebuconazole

Technical

CONFIDENTIAL APPENDIX

The results of five batch analyses are summarized below:

The total material accounted for In the different batches 

### is summarised in the table below



### 999.92 1004.96 984.18 988.45 1000.56

Values 

### found between 

### the Iimtt of quantification 

### (1 g/kg) and 

### the limit of detection 

### (see validation data)

are given 

### between brackets 

## [J

830.1750. Certified limits: (MRID No. 481437-01)

The certified limits for the active ingredient specified on the CSF and on the product label for the basic

formulation are within the OPPTS 830.1750 recommended range. The following are results for the basic

formulation:

Nominal

### Lowe~i~~rtified**Ii~it**

# Anal~si;' No Name Type

### cO~~::!~iOn**co~~::!~ion**

## M~~~:I;i d. (%w"')



# ;. \1,_1**y~:':H-** AI 98.5 95.5 

### toO 98.9 ± 0.84

i

Impurities

I 100% 99.8

Dol, "odl il p.39-50



### 20

### UNI • .::O STATES ENVIRONMENTAL PROTECi ,-..IN AGENCY



### WASHINGTON, D.C. 20460



## July 26,2010

OPP Decision Number: DA36738

EPA File Symbol or Registration Number: 87284-E

Product Name: WILLOWOOD TEBUCONAZOLE TECHNICAL

EPA Application Receipt Date: 02-Jul-20l0

EPA Waiver Request Receipt Date: 02-Jul-2010

EPA Company Number: 87284

Company Name: WILLOWOOD PROPICONAZOLE, LLC

JANELLE KAY

PYXlS REGULATORY CONSULTING, INC.

WILLOWOOD PROPICONAZOLE, LLC

4110 l136TH STREET, NW

GIG HARE OR, WA 98332-

SUBJECT: Approval of 50% Small Business Waiver Request

Dear Registrant: OFFICE OF

PREVENTION, PESTICIDES AND

TOXIC SUBSTANCES



## The Office of Pesticide Programs has approved your request for 50% waiver of the

pesticide registration fee associated with the action referenced above. The decision review

period for this action will begin on the date of this letter.

The Action has been identified as Action Code: R310

NEW PRODUCT;NON-FAST TRACK (INCLUDES REVIEWS OF PRODUCT

CHEMISTRY;ACUTE TOXlCITY;PUBLIC HEALTH PEST EFFICACy);

If you have any questions, please contact the Pesticide Registration Service Fee

Ombudsman, at (703) 308-9362.

Sincerely,

# ~oscar Morales: Director

Information Technology & Resources Management Division

Office of Pesticide Programs

### i



### JNITED STATES ENVIRONMENTAL PR

.... EeTtON AGENCY



### WASHINGTON, D.C. 20460



## July 6, 2010



## opp Decision Number: 

## DA36738

EPA File Symbol or Registration Number: 87284-E

Product Name: WILLOWOOD TEBUCONAZOLE TECHNICAL

EPA Receipt Date: 02-Jul-20l0

EPA Company Number: 87284 OFFICE OF

PREVENTION, PESTICIDES AND

TOXIC SUBSTANCES



## Company Name: WlLLOWOOD PROPICONAZOLE, LLCEPA File Symbol or Registration



## Number:

JANELLE KAY

PYXIS REGULATORY CONSULTING, INC.

WILLOWOOD PROPICONAZOLE, LLC

4110 l136TH STREET, NW

GIG HARBOR, W A 98332-

SUBJECT: Receipt of Application and 50% Small Business Waiver Request

Dear Registrant:

The Office of Pesticide Programs has received your application, 50% small business

waiver request, and cerification of payment. If you submitted data with this application, the

results of the 

## PRN-86-5 screen 

## will be communicated separately. During the administrative

screen, the Office of Pesticide Programs has determined that this Action is subject to a Pesticide

Registration Service Fee as defined in the Pesticide Registration Improvement Act.

The Action has been identified as Action Code: R31 0

NEW PRODUCT;NON-FAST TRACK (INCLUDES REVIEWS OF PRODUCT

CHEMISTRY;ACUTE TOXICITY;PUBLIC HEALTH PEST EFFICACy);

Your request for waiver has been forwarded for review. You will be notified in writing when a

determination is made regarding your request. If your waiver request is approved, the decision

review time period will start on the date of approval. If your waiver request is denied, you will

receive an invoice for the outstanding balance.

If you have any questions, please contact the Pesticide Registration Service Fee

Ombudsman at (703) 308-9362.

Sincerely, " . 

## .--"2::"'-

Front ocessii'

## ~:.rr

# piiAI~ REGULATORY CONSULTbG, INC.

4110 136 th 

### St. NW

Gig Harbor, WA 98332



### OVERNIGHT DELIVERY



### Mary Walle, (PM 21)

Document Processing Desk (REG FEE)



### Office of Pesticide Programs (7504P)

U.S. Environmental Protection Agency

Room S-4900, One Potomac Yard

2777 S. Crystal Drive



### Arlington, VA 22202



## RE: Willowood Propiconazole LLC lune 29, 2010

Willowood Tebuconazole Technical (EPA File Symbol 87284- )

Application for New Pesticide Registration

Dear Ms. Waller, 

## 481437.00

Phone: 253-853-7369

Fax: 253-853-5516

www.PyxisRC.com



### On behalf of WiUowood Propiconazoie, LLC, we are submitting an application for registration of

Willowood Tebuconazole Technical. In support ofthis application, we submit the following documents:

I. Application for a New Pesticide Registration (EPA Fonn 8570-1)

2. Confidential Statement of Fonnula (EPA Fonn 8570-4)

3. Three (3) Copies of the Proposed Labeling

4. A CD containing an ele-.;tronic version of the proposed labeling

5. Certification with Respect to Label Integrity

6. Certification with Respect to Citation of Data (EPA Fonn 8570-34)

7. Agency Internal Use Copy of the Data Matrix

8. Public File Copy of the Data 

### Matrix

9. Copy ofPRIA payment

10. Copy of EPA approval of 50% Small Business Waiver request dated June 14, '2.01J

11. Letter of Authorization

12. Product Specific Data (3 copies of each report):



## 48143701 Volume I 830.1550, 830.1600, Tillman, A. M. Product Identity and Composition, Description of

830.1620,830.1670, the 

### Materials Used, Description of 

### the 

### Production Prc;:..!ss,

830.1750,830.1800 Discussion of the Fonnation of Impurities, Certified**Limi~~,** 

### dnd

Enforcement Analytical Method for Willowood Tebuconazole

Technical. 

### Contains Confl!!ential Business Information.



## 48143702 Volume 2 830.1700,830.1800 Tillman, A. M. Purity Profile for 5 batches of Tebuconazole

## 48143703 Volume 3 830.6302,830.6303,

830.6304,830.6313,

830.6314,830.7000,

830.7050,830.7200,

830.7300



## 48143704 Volume 4 830.6313,830.6315,

830.6316,830.6317,

830.6319,830.6320,

830.6321,830.7100,

830.7220, 830.7370,

830.7520,830.7550-

7570,830.7840-

7860, 830.7950 M. Waller

June 29, 2010

Page 2 of2

Technical. Contains Confidential Business Information.



### Seal, S. Product Property Studies for Tebuconazole TechnicaL

Tillman, A. 

### M. Willowood Tebuconazole Technical Physical and

Chemical Property Waiver Requests.

We would like to note that Willowood Propiconazole, LLC is using the cite-all method of support. As

per EPA's interpretations of 40 CFR Parts 152.86(b)(2)(i) and 152.93(b)(2)(i). Willowood Propiconazole,

LLC submitted notices of intent to apply and offers to pay to all companies on the March 31, 20 I 0 Data

Submitter's List. This action falls under PRlA category R310 (46: New manufacturing use product)

because it is an application for registration for a technical product identical to a currently registered

product. The fee for this action is $4,578, but Willowood Propiconazole, LLC is requesting a 50% PRIA

fee reduction to $2,289. Documentation to support eligibility as a small business has previously been

submitted with the submission for registration ofWillowood Propiconazole Technical (EPA File Symbol

87284-R). The PRIA fee has been paid. The decision timeline is 6 months.

We trust you will find this application complete. However, please feel free to contact me «253) 853-

7369, Ann@PyxisRC.com) if you have any questions or need any additional infomlation.

Sincerely,

Ann M. Tillman

Enclosures

## WILLOWOOD TEBUCONAZOLE TECHNICAL

FOR USE IN FORMULATING FUNGICIDES ONLY

ACTIVE INGREDIENT:

Tebuconazole:**a~[2-(4-chlorophenyl)ethyll-a·(1,** 

### 1-dimelhylethyl)-1 

### H-i ,2,4-triazole-1-

ethanoL

............................................................................................................................. 98.5 %



### OTHER INGREDIENTS

...................................................................................................... 1.5<.1&

TOTAL.

........................................................................ , ................ h •••• 

### 100.0%



### EPA Reg. No.**87284~**



### Manufactured for: 

## KEEP OUT OF REACH OF CHILDREN



# CAUTION

• Move person to air.



### • If person is not 

### breathing, call 911 or an ambulance, then give artificial

respiration, preferably by

, if possible.



### II I

i control or doctor i

• Have person sip a glass of waler if able to swallow.

• Do not induce vomiting unless told 10 do so by the poison control center or

doctor.



### i i

first 

### 5 minutes, then continue

• Rinse



# ,

II

EPA Est. No.

Net Contents:

Willowood Propiconazole, LLC

1600 NW Garden Valley Blvd.

Roseburg, OR 97471

Willowood Tebuconazole Technical Label

## \

PRECAUTIONARY STATEMENTS

HAZARD TO HUMANS AND DOMESTIC ANIMALS

CAUTION. Harmful 

### if swallowed, absorbed through skin, or inhaled. Causes moderate eye irritation.

AVoid contact with eyes, skin or clothing. Avoid breathing dust. Wash thoroughly with soap and water

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

wash contaminated clothing before reuse.



### ENVIRONMENTAL HAZARDS

This product is toxic to mammals, fish, and aquatic invertebrates. Do not discharge effluent containing

this product directly into lakes, streams, ponds, estuaries, oceans or public waters unless in accordance

with the requirements of a National Pollutant Discharge Elimination System (NPDES) permit and the

permitting authority has been notified in writing prior 

### to discharge. 

### Do not discharge effluent containing

this product to sewer systems without previously notifying the local sewage treatment plant authority. For

guidance, contact your State Water Board or Regional Office of the Environmental Protection Agency.



### DIRECTIONS FOR USE

It 

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

This product may only be used to formulate end-use pro::lucts with the following uses:

(1) Terrestrial Food/Feed Crops: Asparagus, Banana and PlantaIn, Barley (seed treatment and

foliar), Beans, Cherries, Corn, Corn (seed treatment), Cotton, Cucurbit Vegetables, Dry Bulb

Onions, Garden Beets, Grasses Grown for Seed, Garlic and Great-Headed (Elephant Garlic),

Grapes, Green Onion, Green Eschalots, Green Shallots, Hops, Japanese Bunching Onion, Leafy



### Brass/ca Greens, Leek, Lychee, Mango (post-harvest), Nectarines, Oats (seed treatment), Okra,

Peaches, Peanuts, Pecans, Soybean, Sunflower, Scallion, Shallot, Spring Onion, Turnip, Welch

Onion, Vllheat (seed treatment & foliar)

(2) Terrestrial non-food uses: Flowers, Ground Covers. House Plants, Ornamental Trees,

Ornamental Shrubs, Roses, Vines

(3) Wood Protection: For end use products that protect wood from wood rotting fungi and for

products -that protect millwork (window frames, wood doors, doorframes, etc.), in-ground wood

products (pil'lngs, telephone poles. wood building materials), and Sapstain control in fresh cut

lumber.

(4) uses for which US EPA has accepted the required data andlor citations of data that the formulator

has submitted in support of registration; and

(5) uses for experimental purposes that are in compliance with U.S. EPA requirements.

Restrictions: Do not package end use products in metal containers.



## STORAGE AND DISPOSAL

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

PESTICIDE STORAGE: Store in original container tlghlly closed and in a safe place.

PESTICIDE DISPOSAL: Pesticide wastes are toxic. Improper disposal of excess pestic'lde, spray

mixture, or rinsate is a violation of Federal Law. If these wastes cannot be disposed of by use accordii IY'

to label instructions, contact your State Pesticide or Environmental Control Agency, or**th~** H.;p:flrdous

Waste representative at the nearest EPA Regional Office for guidance.

Container Disposal- Liner bag: Nonrefillable container. Do not reuse or refill this conte-iner.

Completely empty liner into application equipment by shaking and tapping sides and botto:r, \0 lo')sen

dinging particles. When completely empty offer finer bag for recycling 'If available or dispose\).fJiher in Eo

sanitary landfill. Container Disposal- Outer Drum: Nonrefillable container. Do not reuse or rffil1 this

cofltainer. Vllhen completely empty offer for recycling if available or dispose of drum in a sani\ary··andfill.

Willowood Tebuconazole Technical Label 

### 2

### WARRANTY STATEMENT

IMPORTANT NOTICE -Seller warrants that this product conforms to the chemical description and is



### reasonably fit 

### for purposes stated on the label when used in accordance with the directions and

instructions under normal conditions of use; but neither this warranty nor any other warranty of

merchantability or fitness for a particular purpose, express or implied, extends to the use contrary to label



### instructions, or under conditions not reasonably foreseeable to seller, and to the extent consistent with

applicable Jaw, buyer assumes the risk of any such use,

Willowood Tebuconazole Techl1icaJ Label 

### 3

## WILLOWOOD TEBUCONAZOLE TECHNICAL

FOR USE IN FORMULATING FUNGICIDES ONLY

ACTIVE INGREDIENT:

Tebuconazole: a-[2-(4-chlorophenyl)ethyl]-a-(1, 1·dimethylethyl)-1 

### H-1 ,2,4-triazole-1-

ethanol

................................................................................... '"

............................................ 98.5%

OTHER INGREDIENTS.......

.............................................................. . ......................**~** 

### TOTAL

........................... ",

.......................................... , ........................... . 10D.0°,{,

IF INHALED

IF "SWALLOWED

IF IN EYES:

IF ON SKIN OR

CLOTHING: 

## KEEP OUT OF REACH OF CHILDREN



# CAUTION

FIRST AID



## • 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.

'" 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 the poison control center or

doctor.

• Do not qive ani!hing b;i mouth to an unconscious person.

• 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.

• 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.

Note to Ph sician: No s ecific antidote is available. Treat asym tomaticall

. FO'r Medical Emergencies cail24 Hours a Day 1-800-858-7378. Have the product container or label with 

# I you when callina a Poison Control Center or doctor or going for treatment.

EPA Reg. No. 87284-

Manufactured for:

Willowood Propiconazole, LLC

1600 NW Garden Valley Blvd.

Roseburg, OR 97471

Willowood T ebuconazole Technical Label EPA Est. No.

Net Contents:

### PRECAUTIONARY STATEMENTS

HAZARD TO HUMANS AND DOMESTIC ANIMALS

CAUTION. Harmful jf 

### swallowed, absorbed through skin, or inhaled. Causes moderate 

### eye irritation.

Avoid contact with eyes, skin or clothing. Avoid breathing dust. Wash thoroughly with soap and water

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

wash contaminated clothing before reuse.



### ENVIRONMENTAL HAZARDS

This product is toxic to mammals, fish, and aquatic invertebrates. Do not discharge effluent containing

this product directly into lakes, streams, pondS, estuaries, oceans or public waters unless in accordance

with the reqUirements of a National Pollutant Discharge Elimination System (NPDES) permit and the

permitting authority has been notified in writing prior to discharge. 

## 00 not discharge effluent containing

this product to sewer systems without previously notifying the local sewage treatment plant authority. For

guidance, contact your State Water Board or Regional Office of the Environmental Protection Agency.



### DIRECTIONS FOR USE

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

### its labeling.

This product may only be used to fOrmulate end-use products with the following uses:

(1) Terrestrial Food/Feed Crops: Asparagus, Banana and Plantain, Barley (seed treatment and

foliar), Beans, Cherries, Corn, Corn (seed treatment), Cotton, Cucurbit Vegetables, Dry Bulb

Onions, Garden Beets, Grasses Grown for Seed, Garlic and Great-Headed (Elephant Garlic),

Grapes, Green Onion, Green Eschalots, Green Shallots, Hops, Japanese Bunching Onion, Leafy



### Brassica Greens, Leek, Lychee, Mango (post-harvest), Nectarines, Oats (seed treatment), Okra,

Peaches, Peanuts, Pecans, Soybean, Sunflower, Scallion, Shallot, Spring Onion, Turnip, Welch

Onion, Wheat (seed treatment 

### & foliar)

(2) Terrestriat non-food uses; Flowers, Ground Covers, House Plants, Ornamental Trees,

Ornamental Shrubs, Roses, Vines

(3) Wood Protection: For end use products that protect wood from wood rotting fungi and for

products that protect millwork (window frames, wood doors, doorframes, etc.). in-ground wood

products (pilings, telephone poles. wood building materials), and Sapstain control in fresh cut

lumber.

(4) uses for which US EPA has accepted the required data and/or citations of data that the formulator

has submitted in support of registration; and

(5) uses for experimental purposes that are in compliance with U.S. EPA requirements.

Restrictions: Do not package end use products in metal containers.



## STORAGE AND DISPOSAL

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

PESTlCIDE STORAGE: Store in original container tightly closed and in a safe place.

PESTtCIDE DISPOSAL: Pesticide wastes are toxic. Improper disposal of excess pesticide, spray

mixture, or rinsate is a violation of Federal Law. If these wastes cannot be disposed of by use accordill(f

to label instructions, contact your State Pesticide or Environmental Control Agency. or the H,8?;.,rdous

Waste representative at the nearest EPA Regional Office for guidance.

Container Disposal- Liner bag: Nonrefillable container. Do not reuse or refill this contoiner.

Completely empty liner into application equipment by shaking and tapping sides and bottoiT,**~o** 

### 10.')sen

clinging particles. When completely empty offer liner bag for recycling jf available or dispose'of liner in &



### sanitary landfill. Container Disposal- Outer Drum: Nonrefillable container. Do not reuse or refill this

container. When completely empty offer for recycling if available or dispose of drum in a saniiary"andfill.

Willowood Tebuconazole Technical Label 

### 2

### WARRANTY STATEMENT

IMPORTANT NOTICE -Seller warrants that this product conforms to the chemical description and is



### reasonably fit 

### for purposes stated on the label when used in accordance with the directions and

instructions under normal conditions of use; but neither this warranty nor any other warranty of

merchantability or fitness for a particular purpose, express or implied, extends to the use contrary to label



### instructions, or under conditions not reasonably foreseeable to seller, and to the extent consistent with

applicable law, buyer assumes the risk of any such use,

Willowood Tebuconazole Technical Label 

### 3

# " J



# Completion of 

# 21-Day Content Screen



# PM-**~\**

EPA Reg. #(File Symbol)

# '8la'3'i-t~



# Decision # 

# D L\31oi38

Thank you, 

# Data package delivered to

you on iJUL 27 2010

• 

# (date)



# Jacket/Mini-jacket 

# will be

transferred to you tedatjUl. 282010



# (Pick up from Document Center)



# Registration Division's 21-Day Content Team

# Memorandum

Date: 

# 7 / I 

# 5 / \ 0

,



# To: 

# -Pf---J-'rD-'.-2--=--:\'------" Regulatory Manager

From: Information Services Branch, ITRMD

Your receipt of this data submission is not an

indication that MRIDs for the enclosed studies have

been posted to OPPIN.



# We expect that it will 

# be approximately 5 days

from the above date before the study-level data is

available in 

# OPPIN.

If you have any questions about this process,

please contact Teresa Downs (305-5363).



# This is a:

# ~fully accepted submission

D 

# partially accepted submission

D 

# rejected submission

# 21-Day Screen Completed by

Contractor



# 21-Day Expires on 7-;23-10



# ---- 

# Jacket # 

# ?j7;J'B 

# cf-c

MRID# 

# L/-S/Cf3 7

Content Screen: Recommended to

# ~Fail

86-5 Review: PassedYFaHed/NA



# Transfer This Jacket to:

# PRIA 2 - 21 Day Content Screen Review Worksheet

(EP AlOPP 

## Use Only)

3/23/09

21 Day Screen Start Date: 

# 7 - ::<

- /0



## Experts In-Processing Signa-t:-ur-e 2 

# :'--"i3'.-2i=""',-------c D ;c;-at:-e""'7::---7 -/(j 

## Fee Paid: Yes/



## Division management contacted on issues No Yes Date

EPA Reg. Nurnber:'fJ776 

# if- 

# E

EPA Receipt Date: 

# 7- 

# :z - /

D

Items for Review Yes No N/A*



## 1 Application Form (EPA Form 8570-1)(link to form) signed & 

## complete 

# iIC

ioel uding package type



## Confidential Statement of Formula all boxes completed, form signed, and

# ~ dated (EPA Form 8570-4) (Link 

## to form)

2 a) All inerts (link to http://www.epa.gov/opprdOOI/inertsl), yes no including fragrances, approved for the proposed uses (see 

## '.( Footnote A)



## 3 

## Certification with 

## Respect to Citation of Data (EPA Form 8570-34) (Link to

form) completed and signed (N! 

## A 

## if 100% repack) 

# Y--

Certificate and data matrix consistent 

# XIf applicant is relying on data that are compensable, is the offer yes no

to pay statement included. (see Footnote B)

If applicable, is there a letter of Authorization for exclusive use only.

Formulator's Exemption Statement (EPA Fonn 8570-27) (Link to fonn)

4 completed and signed (N/A 

## if source is unregistered or applicant owns the 

# K technical)

Data Matrix (EPA Form 8570-35) (Link to form) both internal and external 

# >( copies (PR 98-5) (Link to PR 98-5) completed and signed (N/A iflOO%

repack)



## 5 yes no

a) Selective Method (Fee category experts use) 

# X I .

'**-.~** 

# .

b) Cite-All (Fee category experts use)



# . .. " " 

### .-

'c'. .,'; ".'



# .

. , 

# .

, 

## c) Applicant owns all data (Fee category experts use) , ".



### .



## 5 Copies of Label (link to httQ://www.eQa.gov/oQQfeadlllabeling/lrmO 

# X-.

6 (Electronic labels on CD are encouraged and guidance is available)( link to

http://www.epa.gov/pesticides/reguJating/registering/submissions/index.htm#labeJs 

# I )-



## 7 

## Is the data package consistent with PR Notice 86-5 (link to 

## PRN 86·5) 

# 'K

Notice of Filing (link to

8 htt:Q:lJwww.en3.gov/nesticides/regulating/tolerance J:!etitions.htm) included

with petitions (link to 

# >'-**http://www.epa.gov/pesticides/re~latingltolerances.htm)**



## 9 

## If applicable for conventional applications, reduced risk rationale (link to

## ~ http://www.epa.gov/opprdOOl/workplan/reducedrisk.html)

Required Data (link to

h 

## ttJ;!:/ /www.eRa.gov/I!esticides/regulatinR/data 

## reguirements.htm) and/or



## data waivers. See Footnote C.

a) List study (or studies) not included with application



## 10

2

## Comments:

o...SSuCt4.--\:C 

# l- 

# wi

, Sf - S r e ,,''CL-j**M-,~~hl\4. ?~**  

# B=t**o~ Qb!\{J,Ae.--"t-t-~e.J** **A%G.....C-~Mc·'n** 

# .... -**tor,eL:i:t_b-~** ...)

- i"c.t:,\C 

### vel.

QC\'('CL-tl D(\

re.LI-€.JL,!,



# * N/A

- 

## Not Applicable

Footnotes

A. 

## During the 21 day initial content review, all eSFs will be reviewed to determine

whether all inerts listed, including fragrances, are approved for the proposed uses. If an

unapproved inert is identified, the applicant must either 1) resolve the inert issue by, for

example, removing the inert, substituting it with an approved inert, submitting

documentation that EPA approved the inert for the proposed pesticidal uses, correcting

mistakes on the eSF, etc. or 2) provide the data to support OPP approval of the inert or 3)

withdraw the application. Removing or substituting an inert ingredient will require a new

eSF and may require submission of data. All information, forms, data and

documentation resolving the inert issue must have been received by the Agency or the

application withdrawn within the 21 day period, otherwise, the Agency will 

## reject the

application as described below.

To successfully complete this aspect of the 21 day initial content screen, applicants are

strongly encouraged to verify that all inert ingredients have been approved for the

application's uses even if a product is currently registered by consulting the inert Web



## 3

## site [link to http://www.epa.gov/opprdOOllinertsllists.htmlJ and if the inert is not

approved, to obtain the necessary inert approval prior to submitting an application

to register a pesticide product containing that inert ingredient. Some inert

ingredients are no longer approved for food uses or certain types of uses. The name

and/or CAS number on a CSF must match the name and CAS number on this web site.

Simple typographical errors in the name or CAS number have resulted in processing

delays.

If an inert is not listed on the inert ingredient web site and the applicant believes that the

inert has been approved, the applicant should contact the Inert Ingredient Assessment

Branch (nAB) at inertsbranch@epa.govandresolvetheissue. Copies ofthe

correspondence with IIAB resolving the issue should accompany the application. All

new inerts except PIP inerts are reviewed by IIAB. The nAB should also be contacted

for any questions on what supporting data needs to be submitted for and the Agency's

inert review process. Questions on PIP inerts should be directed to the Chief of

Microbial Pesticides Branch [Link to



## httpj/www.epa.gov/oppbppdllbiopesticideslcontactsbppd.htm ].

When a brand, trade, or proprietary name of an inert ingredient is listed on a CSF,

additional information such as an alternate name of the inert, CAS number or other

information [link to http://www.epa.gov/opprd001/inertsitips.pdfl must also be included

to enable the Agency to detennine if it has been approved. Each component of an inert

mixture (including a fragrance) must be identified. 

## In some cases, the supplier of the

mixture or fragrance may need to provide this information 

## to the Agency. Prior to the

Agency's receipt of an application, applicants must arrange with a proprietary mixture or

fragrance supplier to provide the component infonnation to the Agency or promptly upon

EPA's request. If the inert ingredients in a proprietary blend (including fragrances)

cannot or are not identified or provided within the 21-day content review period, the

Agency will reject the application.

During the 21 day content review, applicants should submit information to the individual

identified by the Agency when the applicant is informed of an unapproved inert.

Unapproved Inerts Identified on CSFs

All applications except conventional new products and PIPs

Once an unapproved inert is identified on a CSF, the Agency vvill contact the

applicant with the following options:

1. Correct the application by, for instance, correcting the inert's identity or CAS

number, providing documentation that the inert has been approved, or

removing the unapproved inert from the CSF or replacing it with one that is

approved for the application's uses; or

2. Submit the information and data needed for the Agency to approve the

unapproved inert. If this option is selected and implemented, the Agency may

request an extension in the PRIA decision review timeframe to acconunodate

the inert review/approval process;

4

## 3. Withdraw the application (the Agency retains 25% of the full fee for the fee

category estimated); or

If none ofthese options is selected and implemented by the applicant within the

21 day content review period, the Agency 

## will reject the application and retain

25% of the full fee of the category identified.

Conventional New Product Applications

When the Registration Division identifies an unapproved inert on a CSF vvith an

application for a new product that the applicant has not identified as requiring an

inert approval (R311, R312 or R313), it will contact the applicant with the

follovving options:

1. Correct the application by, for instance, correcting the inert's identity or CAS

number, providing documentation that the inert has been approved, or

removing the unapproved inert from toe CSF or replacing it with one that is

approved for the application's uses; or

2. Submit the information and data needed for the Agency to approve the

unapproved inert, including any required petition to establish or amend a

tolerance or exemption from a tolerance. (This option may change the PRlA



## category for the application, which could require a longer decision review

time and a larger fee. If additional fees are due, they must be received by the

Agency within the 21 day content review period.)

3. Withdraw the application (the Agency retains 25% of the full fee for the fee

category estimated); or

Ifnone of the above options is selected and implemented during the 21**~day content~review**  

## period, the Agency vvill reject the application and retain 25% of

the appropriate fee for the new product-inert approval category.

PIP Applications

\\'hen the Biopesticide and Pollution Prevention Division identifies an

unapproved inert on a PIP CSF and a request to approve the inert does not

accompany the application, it will contact the applicant with the following

options:

1. Correct the application by, for instance, correcting the spelling or name of the

inert to that in 40 CFR 174, or providing documentation that the inert has been

approved; or

2. Submit the information and data needed for the Agency to approve the

unapproved inert. If an inert ingredient tolerance exemption petition is

required, the petition must be received by the Agency and the B903 fee paid

within the 21 day period. If this option is selected and implemented, the

Agency will discuss harmonizing the timeframe for both actions.



## 5

## 3. Withdraw the application (the Agency retains 25% of the full fee for the fee

category estimated); or

If none of the above options is selected and implemented during the 21 day

content review period, the Agency will reject the application and retain 25% of

the fee.

B. 

## A policy on documentation of offers to pay is still being developed, however, for a**me~too** 

## or fast track (similar/identical) new product, R300 or 

## A530, an application

without the necessary authorizations of offers to pay will be placed into either R301 or



## A531. The Agency recommends that authorizations of offers to pay be submitted with

other PRIA applications to avoid delays in 

## the Agency's decision.



# c. Biopesticide applicants are advised to contact the Agency and discuss study waivers

prior to submitting their application to the Agency. Documentation of such discussions

should be submitted with the study waiver.

6

### CDrr-LL~_bfl)



# (' -c:.-L.. 

# e'" (

..**J~_** Script for Rejection PI. " ills



## Contact Name: A il{) Tl \\ Mo.",



# Phone#:**2.S~·'i55!'·1:.',,(,"t** 

# Email:

First Call1Initials: 1< C

Date: 

# "I '4

Time: .z:ZOe(>'\ 

# Second Call1Initials: ICC



# Date: 

# 7/ Ib



## Time: t "

.. 150("'(1-.,



# This is,

________________ , EPA contractor.

I'm calling regarding your submission iu support of

is"=?2 g4-E t..;:!lo'-v'oDd T

..... 

### !ouconC<.-?.o(c

## 1ec:t..fl\c.c...~



# We have found tbe following deficiencies regarding:

PR Notice 86.5:

# ~or No

# ~olume/StuayTitle: 

# vorl!**Pv..r·'+-,ct('~AJc...** {'or

# J?~~\<:--~~>- .£{



## lebue'D!lv....?-eJ c

## l_~C-~0~_~==\ 

# - C«>l'lt:,L::Vlt;C,·l

## A--\k_<:l.,./lA<..n~-**fht..Y>~~** 

# f:;, 87-



# Volume/Study Title: 

# 110 

# l.lI / Is,**\\o",~-,,_J** 

# 1 

# e\'" "'co 

# n<A-wJ**~~C\"f\l=** 

# \**1?'~'19t-c..\** <>-":'

## ~**_~~e-~~~~.£~to..p;~-~** 

# ___**~!D~sr ~0~**  -

## c.qf'l.Q~ 

# Jev\+"c.!**x;:~-c~~~** fYl.-£Vl.-\ 

## iYlv..s>* be....- 

## rCJY'tove..d

,- 

# Volume/Study Title:

Additional volumes continued on back of page: Yes or No

Application Package: Yes o@

Tbese deficieucies have been approved by EPA.

Tbe corrections can be faxed to 703-305-5060/Attn:

_______ _

Second Call1Email:

Ifwe do not receive the corrections by 

## ,we will process



# your submission, accordingly. Please direct all future calls and

correspondence to the appropriate EPA Risk Manager.

# R 310

Must submit Group A and B product chemistry data for each proposed product.



## End Use IEP) or Manufacturing Use IMP) product or Technical Grade of the Active Ingredient ITGAI)

EP 

## Data 

## MP Data

Guideline Group A: 

## Product Chemistry Data Submitted Submitted TGAI

No. Study Title Yes No Yes No Yes No



## 830.1550 Product Identity & 

## Composition c./



## Description of materials used to 

# v 830.1600 produce the product



## 830.1650 Description of formulation process 

# AlI"-

830.1670 Discussion on the formation of impurities**~**



## 830.1700 Preliminary analysis ...-'



## 830.1750 Certified limits 

## 1158.345) 

# v

830.1800 Enforcement analytical method 

### c./

EP 

## Data 

## MP Data

Guideline Group B: Product Chemistry Data Study

## ~~!J)!J~~~~!J)!J~~..'T~G"A"I..,.,,---~ Title No No

I



## to I and 

# /

Ii



## i·

out = 

### not required



## 1

# R 310

New products must either: 1} supply the product specific acute toxicity 6 pack data [listed below},

or 2} 

### provide a bridging rationale document. The bridging document directs opp 

### to use a currently

registered set of 6 acute toxicity data and label; instead of submitting product specific data.

Data

Guideline Acute toxicity (6 pack) submitted 

### Cited

No. Study Title Yes No Yes No

870.1100 Acute Oral (LD50) 

# ./

870.1200 Acute Dermal (LD50) 

# ./

870.1300 Acute Inhalation ILC50) 

# J/

870.2400 Acute Eye Irritation 

## /

870.2500 

### Acute Dermal Irritation 

# J

870.2600 Dermal Sensitization 

# ./

Efficacy

- which guideline is used depends on the proposed label use

Data

Guideline submitted 

### Cited

No. Study Title Yes No Yes No Comments

810.3100 Soil Treatments for Imported Fire Ants

Livestock, Poultry, Fur and Wool-Bearing

810.3200 Animal Treatments

Treatments to Control Pests of Humans

and

810.3300 Pets

Mosquito. Black Fly. and Biting Midge

810.3400 ISand Fly} Treatments

810.3500 Premises Treatments

810.3600 Structural Treatments

Methods for Efficacy Testing of Termite

810.3800 Baits



## 2

### ')

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, D,C, 20460



## July 6, 2010

OPP Decision Number: D-436738

EPA File Symbol or Registration Number: 87284-E

Product Name: WILLOWOOD TEBUCONAZOLE TECHNICAL

EPA Receipt Date: 02-Jul-20 1 0

EPA Company Number: 87284 OFF!CEOF

PREVENTION, PESTICIDES AND

TOXIC SUBSTANCES



## Company Name: WILLOWOOD PROPICONAZOLE, LLCEPA File Symbol or Registration

Number:

JANELLE KAY

PYXIS REGULATORY CONSULTING, INC.

WILLOWOOD PROPICONAZOLE, LLC

4110 1136TH STREET, NW

GIG HARBOR, WA 98332-

SUBJECT: Receipt of Application and 50% Small Business Waiver Request

Dear Registrant:

The Office of Pesticide Programs has received your application, 50% small business

waiver request, and cerification of payment. If you submitted data with this application, the

results of the PRN-86-5 screen will be communicated separately. During the administrative

screen, the Office of Pesticide Programs has detennined that this Action is subject to a Pesticide

Registration Service Fee as defined in the Pesticide Registration Improvement Act.

The Action has been identified as Action Code: R31 0

NEW PRODUCT;NON-FAST TRACK (INCLUDES REVIEWS OF PRODUCT

CHEMISTRY;ACUTE TOXICITY;PUBLIC HEALTH PEST EFFICACY);

Your request for waiver has been forwarded for review. You will be notified-in writing when a

detennination is made regarding your request. If your waiver request is approved, the decision

review time period will start on the date of approvaL If your waiver request is denied, you will

receive an invoice for the outstanding balance.

!fyou have any questions, please contact the Pesticide Registration Service Fee

Ombudsman at (703) 308-9362.

Sincerely:

Front End Pro

# IFee 

# for Servicel 

# {877767cThis package includes the following



# C!J New Registration

°Amendment

, I>1l 

# Studies? 

# ° Fee Waiver?

Dvolpay % 

# Reduction: 5'D for Division



# °AD

°BPPD

C!JRD

Risk Mgr. 

# []I]

Receipt No. 

# s-I 877767**~======:::;** 

# EPA File Symbol/Reg. No.

;::::1

# =8~7~2~84~-~E~ Pin-Punch Date:

,-I 

# _7_/2_1_20_1_0---,



# o This item is NOT subject to FFS action.

Action Code:

I. 

# lpa-r-e-n-tlC-CC-h-il-d-D-e-c-is-i-o-n-s-:

I"



# Requested: 

# I 

# R 31 

# 0

Granted: 

# 11<..

# ~ 1 D



# Amount Due: 

# $ L?S7t'

I!TI 

# Inert Cleared for Intended Use D 

# Uncleared Inert in Product

# ReViewe~f'**!~** Date: 

# 7/&,(;0

I



## Remarks:

## Mike Kellogg

From:



### Sent:

To: paygovadmin@mail.doc.twai.gov

Thursday, July 01, 2010 10:53 AM



### Mike Kellogg



### Subject: Pay. Gov Payment Confirmation



## THIS IS AN AUTOMATED MESSAGE. PLEASE DO NOT REPLY.

Your transaction has been successfully completed.

Transaction Summary

Application Name: PRIA Service Fees

pay.gov Tracking ID: 2512FDDV

Agency Tracking ID: 74124342728

Account Holder Name: Brian Heinze



## Transaction Type: Sale

Transaction Amount: $2,289.88

Billing Address: 8698 Lookingglass Road



## City: Roseburg

State/Province: OR

Zip/Postal Code: 97474

Country: USA

Card Type: Master Card



## Card Number: ************6885

Transaction Date: Jul 1, 2818 1:52:38 PM

Decision Number:

Registration Number: B7284-xx

Company Name: Willowood Propiconazole

Company Number: 87284

Action Code: R310

1 

### ,}"}

;



## , ,

, 

## ,

"



## , "

)



### , 

## ,

,

} 

## , } 

### "



## ,

, 

## " "

} 

### " 

## , 

## "

, > > ,



## , , , ,

# -.

..**-~ -~**  F. A lived. nMB No. ""7 V\I""'" ",,.I.GS

Unitod Stet

.. 

# §

Registration opp Identifier Numbe, 

# oEPA Environmental Protection Agency Amendment

WIIshinllton, OC 2.0460 

## Other

ApDiication for Pesticide

- Section I

I. CQmpllny/Product Number 2. EPA product Maneller 3. Propond Clestiflc_a.n

Willowood Propiconazole LLC/87284- 

# E-" M. Waller

### ~Non. 

# D**A~.trlctod 4~.**  Compenytf'roduct INome) PM'

Willowood Propiconazole, llCiWillowood Tebuconazole Technical 

### 21

5. Namllllnd Addrus of AppliCllnt (tncfudo ztp Code' 6. Expedited Revelw. In accordance with FIFRA Section 3(c1(31

Wiltowood Propicorlazole. LlC (bl(ll. mv product is similar or identical in composition and labeling

c/o Pyxis Regulatory Consulting, Inc. to: 

## 81598-2 4110 136fh Sf. NW EPA Reg. No. Gig Harbor, WA 96332 

# o

Check if fhif ill I new eddrells Product Name Rotam Tebuconazole Technical



### Section**~** 

### II



# 0 Am.ndment

- E"pluin below. 

# U Finel printod labell in repaonn to 

# 0 [2]**Ag~ncv** letter dotod

Rnubminion in rosponso to Agtncv letter detGd**'M~** Too' ApplicotiOrl.



# 0 Notificution· E"ploin below. 

# 0 Oth"

- E"plaln below.

Explanation:**U~e** additional**pogel~1** il nocouo.V. IFo. section I and Ssctlen 11.1

This application falls undel Category 

### R310 (46: New manufacturing use product) because it is an application for registralion for



### a new technical product Identical in compOSition to 

### a currently registered product. The fee which is due is 

### $4,578.00 but

Willowood Proplconazole, LLC is requesting a small business fee reduction of 

### 50% to 

### $2,289. The decision \!meline is 

### 6

months.



### Section**~** 

### III

1. "'e"rilll Thllo Produltl Will h Pa-ckoglld In:

Child_Rulstont Packaging Unit Pockaging Wuter SOluble Pockuging 2. Typo of Container 

# @'" @'"**~** ,,,

# [~r'"

.( N. .( N. .! Plostlc

N. (3lou

If ·Yu· No. pel II ·Yes" No. per -/ Pep" PE lined nbor or

e CfIrlificatJon 

### musr Unit Packogin" w"t. contoiner Packoge wgt contoiner Oth" ISpecifyl HOPE drums 

### Iw submitttH/

3.**L~cetion** of Not**co~enr"** Informotl'on 4. Siulsl Reloil Contelner 

# 15.

Locotion of Lobll Oirections 

# I

r

-/: Lebol 

### I Container**~ o,,~.b.'**  25.50,200, SOD kg

-**o~ La~.II"lI.ooomp.nyinG**  pfDdUC1

6. MOnllO' in Which**Lab~ll.** Affixed to Product UWthoO'iPh 

# U Othflr

P,,!!br r.usd Stonci ltd



### Section ·IV

1. Contact Point /CPmp/efo ilems dir'crty b'/(Jw for idfmlific.tion of md.-vidu.1 to bo c,mfocled, if noceu{II')', to proCfSS this tlPP''-c.rion./

Namb Title 

## ·1 Telephone No.

## !lrlClud~ Are.:: Codel

Pyxis Regulatory Consulting, Inc. Agent

### (25~~}:8~3-?369 '

Certificetion • '\ 6. Oote Appficltion

I cortifV thot tho stallments I hOWl 

### mad. on this form and oil

### ettllchm.nt~ th<!.oto 0.0 trua, Iccurete ond comploll.' , , '

### '~eCI'iVed 

## , 

# . I ecknowltdgo thot any knowlingllv folae d.**mi~l.eding** stlltemlnt mov ba punishable by line or imprieonment or {StaMJ)Cd)

both under applioable law.

,



# .. "',,"" {2

.**~** 3. Titlo 

# I 

# .' U,H!k'! 

# klL'-' Consultant

4. Typed Neme 5.0oto

AnnM. Tillman 

# (,:. /J-C) /

HJ/o

,

EPA Form 8570-' IRIIY. 3-941 ProYlous edItIOns era obsolete. 

### . Vdow • AppkArtt c..y

## WILLOWOOD PROPICONAZOLE, LLC

4110 136· St. NW Phone: 253-853-7369

Gig Harbor, WA 

## 98332

November 9, 2009

Document Processing Desk (COADR)

Office o[Pesticide Programs (7504P)

U.S. Environmental Protection Agency

Room S-4900, One Potomac Yard

2777 S, Crystal Drive

Arlington, VA 22202



## To Whom It 

## May Concern:

RE: Letter of Authorization Fax: 253-853-5516

Please let this letter serve to notify you that Pyxis RegulatoI)' Consulting, Inc. (contact

information below) is authorized to 

## represent WilJowood Propiconazole, LLC (Co. No. pending)

as authorized agent before the U.S. Environmental Protection Agency in all matters regarding

OUf 

## pesticide registrations and applications for registrations pursuant to the Federal Insecticide.

Fungicide and Rodenticide Act (FIFRA). 7 USC Section 136 et seq. Direct all official

correspondence from EPA to:

Agent:



## Pyxis Regulatory Consulting. Inc,

4110136· St. NW

Gig Harbor, WA 

## 98332

T: (253) 853-7369

F: (253) 853-5516

info@PyxisRC.com



## If you have any questions, please do not hesitate to contact me.

Sincerely, ",>}>



## , ,



# , ,

, 

## "



# , , "



## , ,



# , ,



# " ,>

>J

,



## ,

, > ,.)



## , 

## ",



# "

, ,

,

, ,

, 

## "



# , "



# ,

# ~~~ ,**~, ~** **~"** 

# ,

, • l >

•• > ;



## President

WiIlowood Propiconazole, LLC

cc: Pyxis Regulatory Consulting. Inc.

## )



# Certification with Respect to Label Integrity

version: **9f11f02**



## I certify that the information (including, but not limited to, text, tables, and graphics)

contained in the electronic file identified below by file name and submitted with this



## certification is the same information as that on the paper copies of these documents

included with this submission.

IPROPOSED LABEL



## Date Submitted

EPA 

## Registration 

## # to EPA 

## Electronic file name

087284-xxxxx June 29,2010 087284-xxxxx.201006xx.Willowood

Tebuconazole Technical label v1.pdf

I certify that the statements that I have made on this form are true, accurate, and

complete. I acknowledge that any knowingly false or misleading statements may be

punishable by fine or imprisonment or both under applicable law.

Signature

Ann M. Tillman June 29, 2010

Date

Consultant, Willowood Propiconazole, LLC

j , ,

,**»-'~** "



# . 

# .,

, "



## , 

# .

"",



### ,



# . 

# .

. .

>, J "



## ,

, 

### "

, , 

## , , 

### "



## , "

'"



## ,

, 

## , , 

## ,FOml**Appro~Bd** OMS No, 2070-OOS0

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

401 M Street, S.W.

WASHINGTON, D.C. 20460

PaperwQrk Reduction Act Notice: The pul:lic reporting burden lor lhis collection olinformation is estimaled 10 mverage 1 ,25 hours per response lor registration

and 025 hours per response lor reregl&traHon and special review ac:tivlUes,**indl.ldin~** lime for reading the inslructions and compleUng !he necessary forms Send

commenti regilfding burden eslimate or any olher aspect olthis COllection ofin/omlalion, including**sugge~lions** lor redudng lhe bU"den to: Director, OPPE

Information ManllJemcnt Division {21371, U.S. Environmental Prolection I'gency, 40t M Slreet. S,w.,**wa~hinglon,** DC 20400.

Do not send**~e** completed fOmllO this address.

Certification With Respect to Citation of Data

Applic;anl'slRegislranl's Name, A:ldress, and Telephone Number

WiUowoO\l Propiconalole, LLC clo Pyxis Regulalory4tl0 13S1h 51. NW Gig Harbor. WA 98332, 2fj

Active InoredienUsl anti/Of rllPfesenlative resl comoound(st

Tebuconazolo

GeoBr.l1 Use Pattem(sl**f~51** af those daimed for this product usinll 40 O'R**P~rt** r56t

TGAI EPA Regislralion NumberlFile S)mbo!

87284·

Oate

Juno 29. 2010

Producl**N~me** WiIlOWO<XI TebuconazoleTechnical

NOTE: If your product is a 100% repackag1ng of ano1her pun::hased EPA--regisWed product labeled for aU the same uses on your label. you dO not need to

5ubmitlhis form. You must submilthe Formula\o(s Exemption Slatement (EPA Form 8570·27).



# o

o 10m reSpOnding loa Dala-CaU.ln Notice, and haw included wilh this form a list of rompanies senl offers of comperoation {the ()ala**Mafrj~** form should

be used lor lhis purpose).

SECTION I: METHOD OFOATA SUPPORT (Check one method only)

I am using lhe tile·all method of support, and haw included wilh this IDml

a li!l otcompanies $enl offem of rompen5atlon (the Data Ma1rix form

shou\;j be lI'led for this purpose). I am using lhe selective melhod 01 support (or ole-all option

under the se1edlve method), and have included with this fOml a completed list of data requilllmenls (the Data**Mal~x** form must be

used).

SECTION tl: GENERAL OFFER TO PAY

[Required it using the tile-all method or when using lhe**ole-a~** option underlhe selective method!O satisfy one or more data requirementsl 

## [2] I hereby offer and agree 10 pay

### compensa~on, 10 other persons, with regard 10 the approval of Ihis application, 10 the exlenl required by FIFRA.

SECTION ttt; CERTIFICATION

I certify that this iiPpication lor registralio(\, ttlis form for**rereg~lrntion,** Of this ()aw-Gall·ln response is supported by al data submitted« cited In the

application for rll9islration, the foml for reregistration,« lhe Dala-Call·ln reeponse. In addition. if the cije-all opoon or dte--all option under Ihe selective method i5

indicated in Sadion I, this appijcation is supported by al data in the**A;Jenr:y'~** files thai (t) roncem lhe properties orel'fl!cts of this produd or an**identic~1** or**substanti~~y** similar product, or one or more ot lhe ingrcdients in this product; and (2) is a Iype of datllihal would be required 10 be submilted under lhe dalll

requirements in effect on lhe date of approV<lI 01 lhis**appli~tion** !fthe**ilPp~ciltion** SOughl the initial registralion of a product oliden"::al or similar campositlon and

uses.

l()l!rtify thai for each exdusive use study cited in support ollhis registration or reregislration, !hall am the oog

.... al dali"l submitter or lhatl haw obtahled

the ""';lron permiSsion olthe original data submitterlo ole lhat stl.ldy.

I certify that for each sll.ldy ciled i'1 support**ofth~** reglstraUon orreregistratlon thall!; nol an exdusiue use study, eilher. (a) I am the original dati

sUbrniller. (b) I have obtained !he permission of the Original dala submilter to use the sludy in support oflhis appicatlon; (ci all perjods of e1igibilrty for

rompensatioo hi!wexpred for the study; (d) !he study is in the pubi<: literature; or Ie) I haw notified In wrWns the company that submitted the study and haw

offered (I) to pay compensation to the exrent required by $Ilctions 3(c)(1)(F) ard/or3(c)(2)(B) ofFIFRA: and (ii) to romJYlenoo negotlalions 10 delsrmine ttle

amourt and lorms of compensation. Jf any, to be paid for the use of lhe study.



### . 

## , 

# .'



# . I c:ertify lhat in all instanc:es Where an offer of compoosalion is required, copies**ola~** offers 10 pay rompensaUon and e",denct! 01 their deUvery**i~** >

accordanc!lwilh sections 3(c)[I)(F) andlor 3(c)(2XB) of FIFRA are available and will be submitted 10 the Agen::y upOn request. 3tbakllt1illo .,-odUC!l su&'

evidence to the Agency upOn request. I underst3nd that the Agency may iniliale action to deny. cancel or suspend the registrnlior,ol 

## fll"t pnduct in confonllily with

FIFRA. ' ,

t cortify that tim statomonts t havo mada on this form and att alachfTlllnlS \0 It are !ruo, accurav, and complolo. ]**ack..~owlodgc** that any knOWingly I;IlsO or mill.adlnll sbltomont may bo punishable by Me (II' Imprisonment or both undor appllcablo law

0 , , • •

Signature

EPA FOml B57!r-J-'I 19·97) Electronic and P!lper verr.ions avaiable, Sub mil only Paper version. 

## , , Typed Of Pnnled Name and Tilll

>, , " Ann M. Tillman, Agenl 

### "



## ,

, , ",,»



## , , , 

# .From: DCOPPAPPSOl/DC/USEPAlUS@epamail epa.goy on behalf of Pesticide Reqistration ImptOvement Act

To:

Subject:

Date:

June 14, 2010

OFFICE OF Ann Tlilman

Waiver: Approval (50%)

- No payment requested

Monday, June 14, 2010 3:18:20 PM

PREVENTION, PESTICIDES AND

TOXIC SUBSTANCES

OPP Decision Number: D-434097

EPA FfJe SymbDI or Registration Number: 87284-R

Product Name: WlLLOWOOD PROPICONAZOLE TECHNICAL

EPA Application Receipt Date: 24-May-2010

EPA Waiver Request Receipt Date: 24-May-2010

EPA Company Number: 87284

Company Name: WILLOWOOD PROPICONAZOLE, LLC

JANELLE KAY

PYXIS REGULATORY CONSULTING, INC.

WILLOWOOD PROPICONA20LE, LLC

4110 1136TH STREET, NW

GIG HARBOR, WA 9B332-

SUBJECf: Approval of 50% Small Business Waiver Request

Dear Registrant:

The Office of Pesticide Programs has approved your request for 50%

waiver of the pesticide registration fee associated with the action

referenced above. The decision review period for this action will begin

on the date of this letter.

The Action has been identified as Action Code: R310

NEW PRODUCf;NON-FAST TRACK {INCLUDES REVIEWS OF PRODUCT CHEMISTRY;ACUTE

TOXICITYiPUBUC HEALTH PEST EFFICACY)i ' , ,} , }



### , 

## ,

If you have any questions, please contact the Pesticide

Registration Service Fee Ombudsman, at (703) 305-6249,

Sincerely,

Oscar Morales,

Director

Information

Technology 

### & Resources Management Division

Office of Pesticide

Programs 

### , 

## ,

,

, 

# , ,."

, 

## "



# ,

"

, , 

## "

, 

## "

> , , ,

### ) ')



## PYXI,; REGULATORY CONSULTING, iNC.

4110 136 1h 

### St. NW

Gig Harbor, WA 98332



### OVERNIGHT DELIVERY

Mary Waller (PM 21)

Document Processing Desk (REGFEE)

Office of Pesticide Programs (7504P)

U.S. Environmental Protection Agency

Room S-4900, One Potomac Yard

2777 S. Crystal Drive

Arlington, VA 22202

RE: Willowood Propiconazole LLC June 29, 2010

Willowood Tebuconazole Technical (EPA File Symbol 87284- )

Application for New Pesticide Registration

Dear Ms. Waller, Phone: 253-853-7369

Fax: 253-853-5516

www.PyxisRC.com

On behalf of Willowood Propiconazole, LLC, we are submitting an application for registration of

Willowood Tebuconazole Technical. In support of this application, we submit the following documents:

I. Application for a New Pesticide Registration (EPA Fonn 8570-1)

2. Confidential Statement of Fonnula (EPA Fonn 8570-4)

3. Three (3) Copies of the Proposed Labeling

4. A CD containing an electronic version of the proposed labeling

5. Certification with Respect to Label Integrity

6. Certification with Respect to Citation of Data (EPA Fonn 8570-34)

7. Agency Internal Use Copy of the Data Matrix

8. Public File Copy of the Data Matrix

9. Copy ofPRIA payment " ,**~':** 

### 10. Copy of EPA approval of 50% Small Business Waiver request dated June 14, 201 

# a :

II. Letter of Authorization " , , , , ,

12. Product Specific Data (3 copies of each report): 

## , '

, , 

## , 

## "

"

,

, , 

## "

Volume 1 830.1550,830.1600, Tillman, A. 

### M. Product Identity and

## Comp~~itio~,**Descilipfio~'** of

830.1620, 830.1670, the Materials Used, Description of the Production V!lC;:e!iS,



### 830.1750,830.1800 Discussion of the Fonnation of Impurities, Certified Limit::!,> and

Enforcement Analytical Method for Willowood Tebuconazole

Technical. Contains

## C~~lidential Business

## i~formation.

Volume 2 830.1700, 830.1800 Tillman, A. M. Purity Profile for 5 batches of Tebuconazole

### Volume 3 830.6302, 830.6303,

830.6304,830.6313,

830.6314,830.7000,

830.7050,830.7200,

830.7300

Volume 4 830.6313,830.6315,



### 830.6316,830.6317,

830.6319,830.6320,

830.6321,830.7100,

830.7220,830.7370,

830.7520,830.7550-

7570,830.7840-

7860,830.7950 M. Waller

June 29, 2010

Page 20f2

Technical. Cantains Confidential Business Information.



### Seal, S. Product Property Studies for Tebuconazole Technical.

Tillman, A. 

### M. Willowood Tebuconazole Technical Physical and

Chemical Property Waiver Requests.

We would like to note that Willowood Propiconazole, LLC is using the cite-all method of support. As

per EPA's interpretations of 40 CPR Parts 152.86(b)(2)(i) and 152.93(b)(2)(i), Willowood Propiconazole,

LLC submitted notices of intent to apply and offers to pay to all companies on the March 31, 2010 Data

Submitter's List. This action falls under PRIA category R310 (46: New manufacturing use product)

because it is an application for registration for a technical product identical to a currently registered

product. The fee for this action is $4,578, but Willowood Propiconazole, LLC is requesting a 50% PRIA

fee reduction to $2,289. Documentation to support eligibility as a small business has previously been

submitted with the submission for registration ofWillowood Propiconazole Technical (EPA Pile Symbol

87284-R). The PRIA fee has been paid. The decision timeline is 6 months.

We trust you will find this application complete. However, please feel free to contact me «253) 853-

7369, Ann@PyxisRC.com) if you have any questions or need any additional information.

Sincerely,

Ann M. Tillman

Enclosures " , , ' >



# ..



# .

. , 

## "

,



# "



# . .



# . "

, > , ,FormApprovedOMSNo.2070-0060UNITEDSTATESENVIRONMENTALPROTECTIONAGENCY401MStreet,S.W.WASHINGTON,D.C.20460PaperworkReductionActNotice:Thepublicreportingburdenforthiscollectionofinformationisestimatedtoaverage0.25hoursperresponseforregistrationactivitiesand0.25hoursperresponseforreregistrationandspecialreviewactivities,includingtimeforreadingtheinstructionsandcompletingthenecessaryforms.Sendcommentsregardingtheburdenestimateoranyotheraspectofthiscollectionofinformation,includingsuggestionsforreducingtheburdento:Director,OPPEInformationManagementDivision(2137),U.S.EnvironmentalProtectionAgency,401MStreet,S.W.,Washington,DC20460.Donotsendtheformtothisaddress.Applicant'sfRegistrant'sName&Address•..•.•WillowoodPropiconazole,LLC1600NWGardenValleyBlvd.DATAMATRIXEPAFonn8570-35(9-97)ElectronicandPaperversionsavailable.SubmitonlyPaperversion.ProductWillowocdTebuconazoleTechnicalWillowoodPropiconazole,LLCIOWNWillowoodWillowoodPropiconazole,LLCDataNameandTitleDaleAnnM.Tillman,ConsultantJune27,2010PublicUseCopyFormApprovedOMSNo.2070-0060UNITEDSTATESENVIRONMENTALPROTECTIONAGENCY401MStreet,S.W.WASHINGTON,D.C.20460PaperworkReductionActNotice:Thepublicreportingburdenforthiscollectionofinformationisestimatedtoaverage0.25hoursperresponseforregistrationactivitiesand0.25hoursperresponseforreregistrationandspecialreviewactivities,includingtimeforreadingtheinstructionsandcompletingthenecessaryforms.Sendcommentsregardingtheburdenestimateoranyotheraspectofthiscollectionofinformation,includingsuggestionsforreducingtheburdento:Director,OPPEInformationManagementDivision(2137),U.S.EnvironmentalProtectionAgency,401MStreet,S.W.,Washington,DC20460.Donotsendtheformtothisaddress.2010Applicant's/Registrant'sName&Address••WiJlowoodPropiconazole,LLC1600NWGardenValleyBlvd.DATAMATRIXEPAForm8570·35(9-97)ElectronicandPaperversionsavailable.SubmllonlyProductWilJowoodTebuconazoleTechnicalWilJowoodWaiverNameandTitleDaleAnnM.Tillman,ConsultantJune27,2010PublicUseCopyFormApprovedOMSNo.2070..Q060UNITEDSTATESENVIRONMENTALPROTECTIONAGENCY401Mstreet,S.W.WASHINGTON,D.C.20460PaperworkReductionActNotice:Thepublicreportingburdenforthiscollectionofinformationisestimatedtoaverage0.25hoursperresponseforregistrationactivitiesand0.25hoursperresponseforreregistrationandspecialreviewactivities,includingtimeforreadingtheinstructionsandcompletingthenecessaryforms.Sendcommentsregardingtheburdenestimateoranyotheraspectofthiscollectionofinformation,includingsuggestionsforreducingtheburdento:Director,OPPEInformationManagementDivision(2137),U.S.EnvironmentalProtectionAgency,401MStreet,S.W.,Washington,DC20460.Donotsendtheformtothisaddress.DateJune27,2010Applicant's/Registrant'sName&AddressSignalure"•WillowoodPropiconazole,LLC1600NWGardenValleyBlvd.DATAMATRIXEPAFonn8570-35(9-97)ElectronicandPaperversionsavailable.SubmitonlyPaperversion.ProductWillowoodTebuconazoleTechnicalNotReauired'WillowoodPropiconazole,LLCIPLSee830.7550See830.7550WillowoodPropiconazole,LLCIPLPAYNameandTitleDateAnnM.Tillman,ConsultantJune27,2010PublicUseCopyFormApprovedOMBNo.2070-0060UNITEDSTATESENVIRONMENTALPROTECTIONAGENCY401MStreet,S.W.WASHINGTON,D.C.20460PaperworkReductionActNotice:Thepublicreportingburdenforthiscollectionofinformationisestimatedtoaverage0.25hoursperresponseforregistrationactivitiesand0.25hoursperresponseforreregistrationandspecialreviewactivities,includingtimeforreadingtheinstructionsandcompletingthenecessaryfonns.Sendcommentsregardingtheburdenestimateoranyotheraspectofthiscollectionofinfonnation,includingsuggestionsforreducingtheburdento:Director,OPPEInformationManagementDivision(2137),U.S.EnvironmentalProtectionAgency,401MStreet,S.W.,Washington,DC20460.Donotsendthefonntothisaddress.Date2010Applicant's/Registrant'sName&AddressSignature"""Wi!lowoodPropiconazole,LLC1600NWGardenValleyBlvd.• •"DATAMATRIXEPAForm8570·35(9·97)ElectronicandPaperversionsaYailable.SubmitonlyPaperversion.ProductWillowoodTebuconazoleTechnicalFMCCorp.AgriculturalPAYPAYInc.PAYNameandTilleOateAnnM.Tillman,ConsultantJune27,2010PublicUseCopyFormApprovedOMSNo.2070-0060UNITEDSTATESENVIRONMENTALPROTECTIONAGENCY401MStreet,S.W.WASHINGTON,D.C.20460PaperworkReductionActNotice:Thepublicreportingburdenforthiscollectionofinformationisestimatedtoaverage0.25hoursperresponseforregistrationactivitiesand0.25hoursperresponseforreregistrationandspecialreviewactivities,includingtimeforreadingtheinstructionsandcompletingthenecessaryforms.Sendcommentsregardingtheburdenestimateoranyotheraspectofthiscollectionofinformation,includingsuggestionsforreducingtheburdento:Director,OPPEInformationManagementDivision(2137),U.S.EnvironmentalProtectionAgency,401MStreet,S.W.,Washington,DC20460.Donotsendtheformtothisaddress.Applicant's/Registrant'sName&AddressWillowoodPropiconazole,LLC1600NWGardenValleyBlvd.OR• •...".DATAMATRIXEPAForm8570-35(9-97)ElectronicandPaperversionsavailable.SubmilonlyPapervers·lon.ProductWillowoodTebuconazoleTechnicalNameandTilleOateAnnM.Tillman,ConsultantJune27,2010PublicUseCopyFonnApprovedOMBNo.2070-0060UNITEDSTATESENVIRONMENTALPROTECTIONAGENCY401MStreet,S.W.WASHINGTON,D.C,20460PaperworkReductionActNotice:Thepublicreporting burdenforthiscollectionofinformationisestimatedtoaverage0.25hoursperresponseforregistrationactivitiesand0.25hoursperresponseforreregistrationandspecialreviewactivities,includingtimeforreadingtheinstructionsandcompletingthenecessaryforms.Sendcommentsregardingtheburdenestimateoranyotheraspectofthiscollectionofinformation,includingsuggestionsforreducingtheburdento:Director,OPPEInformationManagementDivision(2137),U.S.EnvironmentalProtectionAgency,401MStreet,S.W.,Washington,DC20460.Donotsendtheformtothisaddress.App!icant's/Registrant'sName&AddressWiUowoodPropiconazo!e,LLC1600NWGardenValleyBlvd.OR...DATAMATRIXEPAForm8570-35(9.fl7)Electron'lCandPaperversionsava'iable.SubmitonlyPaperversion.ProductWillowoodTebuconazoleTechnica!MakhteshimAganofNorthIPAYPAYAgnculturalReentryTaskDaleAnnM.Tillman,ConsultantJune27,2010PublicUseCopyFormApprovedOMBNo.2070-0060UNITEDSTATESENVIRONMENTALPROTECTIONAGENCY401MStreet,S.W.WASHINGTON.D.C.20460PaperworkReductionActNotice:Thepublicreportingburdenforthiscollectionofinformationisestimatedtoaverage0.25hoursperresponseforregistrationactivitiesand0.25hoursperresponseforreregistrationandspecialreviewactivities,includingtimeforreadingtheinstructionsandcompletingthenecessaryforms.Sendcommentsregardingtheburdenestimateoranyotheraspectofthiscollectionofinformation,includingsuggestionsforreducingtheburdento:Director,OPPEInformationManagementDivision(2137),U.S.EnvironmentalProtectionAgency,401MStreet,S.W.,Washington,DC20460.Donotsendtheformtothisaddress.Applicant's/Registrant'sName&AddressWillowoodPropiconazole,LLC1600NWGardenVaneyBlvd....DATAMATRIXEPAForm8570-35(9-97)ElectronicandPaperversionsavailable.SubmitonlyPaperversion.EPA87284-of8ProductWillowoodTebuconazoleTechnicalPAYChemicals&CropIPAYOateAnnM.Tillman,ConsultantJune27,2010PublicUseCopyFonnApprovedOMBNo.2070-0060UNITEDSTATESENVIRONMENTALPROTECTIONAGENCY401MStreet,S.W.WASHINGTON,D.C.20460PaperworkReductionActNotice:Thepublicreportingburdenforthiscollectionofinformationisestimatedtoaverage0.25hoursperresponseforregistrationactivitiesand0.25hoursperresponseforreregistrationandspecialreviewactivities,includingtimeforreadingtheinstructionsandcompletingthenecessaryfonns.Sendcommentsregardingtheburdenestimateoranyotheraspectofthiscollectionofinformation,includingsuggestionsforreducingtheburdento:Director,OPPEInfonnationManagementDivision(2137),U.S.EnvironmentalProtectionAgency,401MStreet,S.W.,Washington,DC20460.Donotsendtheformtothisaddress.Applicant's/Registrant'sName&AddressWillowoodPropiconazole,LLC1600NWGardenValleyBlvd.'.'"w....,.,.DATAMATRIXEPAForm8570-35(9-97)ElectronicandPaperversionsavailable.SubmitonlyPaperversion.ProductWillowoodTebuconazoleTechnicalShardaWorldwideExportsIPAYPvt.Ltd.PAYDaleAnnM.Tillman,ConsultantJune27,2010PublicUseCopy