# EPA Registration Number

35935 -79

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# & EPA United States 

# o Registration QPP Identifier Number

Environmental Protection Agency 

# Cj Amendment

Washing1on, DC 20460**~** 

## Other: 

# FP!-

Application for Pesticide

- Section I

1. Company/Product Number 2. EPA Product Manager 3. Proposed Classification

Nufarm Ltd

EPA Rea. No. 35935-79 Mary Waller

4. Company/Product (Name) PM'

## ~None 

# D Restricted

Metalaxvl Technical 

### 21

5. Name and Address of Applicant (Include ZIP Code) 

### 6. Expedited Review. In accordance with FIFRA Section 3(c)(3)

Nufarm Ltd (b)(I), my product is similar or identical in composition and labeling

PO BOX 13439 to: RTP, North Carolina 27709 EPA Reg, No.: 

# o

Check 

### if this is a new address 

### Product Name:

Section -II



# D Amendment

- Explain below. 

# [2J Final printed labels in response to Agency letter dated JUL 21 2010 

# o ResubmisSion in response to Agency letter dated 

# D "Me 

### Too" Application 

# o Notification

- Explain below, 

# o Other

- Explain belOW

Explanation: Use additional page(s) if necessary. (For Section I and Section 11.)

Final Printed Label

Section -III

1 

### Material This Product Will Be Packa ed In:

Child·Resistant Packaging Unit Packaging Water Soluble Packaging 2. Type of Container 

# o Yes* 

## DYes DYes 

# D Metal 

# IZl No 

# IZl No 

# IZl No 

# [ZJ Plastic

If "Yes" No. per If "Yes" No. per 

# o Glass



## *Certification must Unit Packaging wgt. container Package wgt. container 

# o Paper



## besubmnted 

# o Other (Specify)

3. Location of Net Contents Information 4. Size(s) Re1ail Container 5. Location of Label Directions 

# [ZJ Label 

# o Container 

# [ZJ On Label

25,200 Kg 

# o On labeling

## accomp:l1~'ing ;)foduC!

6, Manner in Which Label is AffIXed to Product 

## D lithograph 

# o Olher



### [8] Paper glued 

## D Stenciled

Section -IV

t, Contact Point (Comp/e/e items directly 

### be/ow for identification 

### of individual 

### to be con/acted, 

### if necessary. to

### p,("c~3-'his app/h:/::n)



### Name Title 

# I**Te!e;Jhor.~** 

### No. (IncluJe Area Code)

Nathan P. Ehresman Director, Regulatory Affairs**919~655-O018**



### Certification 6. D<.l1e Application

I certify that the statements I have made on this form and all attachmenls thereto are true. accurate and complete. Re'::3:v3d

I acknowledge that any knowingly false or misleading statement may be punishable by fine or imprisonment or iGtc.mped)

both under applicable law.

2. Signature

## ~f7~ 3. Title

irector, Reaulatorv Affairs

4, Typed Name" 4. Date

Nathan P. Ehresman July 27, 2010

EPA Form 8570-1 (Rev. 8_94) Previous editions are obsolete White- EPA File Copy (original) Yellow- Applicant CopyMETALAXYLTECHNICALACTIVEtNGREDlENT:Met,1Ia>¥:-al;)mnemeth)'!ester....97.0%OTHERINGREDIENTS:..................................................3.0",(,TOTAL......H)(W%EPAR"!J.No.35935-79EPAEsLNo.81092-CHN.{J01KEEPOUTOFREACHOFCHILDRENWARNINGForCherricaiLeak,Fore,orExposure,CalCHEMTREC(800)424-9300ForMedk:alEmergenciesOnly,Call(B77)325-184<)FIRSTAID•Holdeyeo""nandrinsestD\,;yandgently",;Ih""Ierlor15to20minutes.IFINEyES•Removecontactlen""s.present.aflerthefi!Sl5mimlles.thencollinuerinsingeye.•Gallapoisoncontrolcenterordoctorl"'lreatmentatMce.•Gallapoisoncontrolcenletordoctorimmedi51e!yfortreatmentad';ce.IFSWALLOWED•Ha..-epersonSIpaglassof"",l...ifatle10SI"I'ilIlow.•DONOTinducevornilirl!lunlessloldtodoSobyapoi"",ncontwlcenterordoctor.•DONOTivetoanunconsciousperson,IFONSKINOR•TakeoffcontaminateddOlhing.•Ri"';imrnedalely",;Ihplentyofwalerlor15to2{)mir"OJles.CLOTHlNG•Calla001conlrolcenletordoctmforlreatmenladvice.•Jl"fSQ(Itofreshair.IFINHALEO•IfpersonisnOIbreathing,call9ffmanambulance.thengiveilI10fidairespirallQ(l,preferablybymoulh-to-mouth,"pOSSlUe,•CamapoiSOllcontrolcenterordoctorlorturthert",atmentadllice,HOTLINENUMBERHaveIheproduclcontainerorlabel"'thyouvd1enceilingapoiSOllcontrol"""Ierordoctor,orgoingforYoumayconlact1-877-325-1840loremergen",""",",,.altrooImenIlnlotn!l>!ion.-PRECAUTIONARYSTATEMENTSHAZARDSTOHUMANSANDDOMESTICANIMALSWARNINGC""""Sbllltemporaryeveimta!ion.Harmfuls"rdl/ov.edorabsorbedU1roughlhesl<in.Wealgogglesorfaceshield.00NOTget'II'eyesoronctolh''''g.Washthoroogrqafterhandflng,RemovecontaminatedcIolhingandwasilbelOIereuse.ENVIRONMENTALHAZARDSDONOTdischargeeffluenlcontainingIhisprodllC!intoIal<es,streams,poods,estuaoos,oceans.orpublicwalersunlessinaocortlt>ncewththerequirementsotaNationalPolkJtanto;""""'1IeSystem(NPOES)permilaridtheperml!IJngaL:h<ml;:1,,"been;.olif,,,,-,In'Mltingprim10disdlarge.00NOTdisdlargeeffluentconlainir.rIhlsorodurt'o"""",rsy;lems.,.,;tr.rnrtprellioustvnotifyingthelocalsewagetreatmentpia"'au!h<'1ty."'org./:lancccontaclyourSlateW&.arBoardOrRegionalOff"",OftheEPA.DIRECTIONSFORUSEItisaofFederallawtouseth1sprodllC!inamanner",,,,:misfentv.ithitslabeling.Thisprur;lo;clisinlendedforthetormulationotlunglCJdeThisprod"":maybvusedtoIormtJlaleproductslorspoof"use{s)notlisted00th'"MP:<>belItI<;'tor",ula,or.usergrotf',org""",rhilscompOedy,;thlheU.S.EPAd';",",'lbmisNOI1fe<1uill'meetslhesuppertotsuchlIse{.).FORMANUFACTURINGUSEONLYFORMANUFACTURINGUSEONLYINTOAFUNGICIDEFORTHEFOLLOWINGUSES,f.TerrestrialFoodCropsIncludingHomeGardensaliefOrchards:Alfalfa,BirdfooltrefOIl.Apples,Asparagus,AlIOCat!oS,Be!ries:CranbelTies,Raspbernes,Sirawb",,;es),CaSS""<l,Cilrus'(Citrusti!rOn,Grapefrull,Kumquats.Lemons,urnes.Oranges,Tangelos.TangerinesaridaIhybridsofthese).CdeCrops:Cetlbage.Caulitlo"",r,Chinesebrocroli,Gailon,VI.t1itetkl'o'aingbroccolo,CIlmesecattlage(Napa,80kchJy),Coffon.Cocurbits:(Ba;",mpear,Chines..v.oaxgolmJ,meloo.Cuwmber.Gherkin,Ediblegourds,Cantalo<4le,Casaba,Crenshaw.Horleydewmelon,Honeyballs,Mangomelon,Muskmelon,Pen;iaomobn.Pumpkin.Summarsquash,\/',InlerSQUash,Watermelon,andCuCUrtlitshybnds),Ginserog,Hops,Leafy(HeadLelluoo,Spinach).LegumeVegelables(SucculentorOned):(Fieldbealls,Limabeans,Mungbeans,Navybeans,Pintobeans,Runnerbeans,Snapbeans,Waxboons,Bro,,"bean.(Favabeans),Chickpea.(Gaibanzobeans),Lentils,Lupines(s.....oel,While'''''''It,VI.t1itearidGrain),Garden""as.Fieldpeas,Sugarpeas,Southernpeas(BIock-eyedpeas.Crov.tierpea.,eo,,>,eas,Catjang)andEdiblesoybeans,Onions'(Doybulb.GreenOtlioos.Spring""ionsorScalliOns,J"Ilanesebunchingonions,GreenshailolsorGreene"""a1ots.Leeks).Nuttrees'(AlmondandVValnuls),Peanllls.PeppersandEggplant.PireapPla,RootamTuberVegetables:(JerusalemartJchoke.Bect(SugarandTable),Carrot,Cassava,Chioooy,Ginger,Horseradim,Parsnip.Potato,RadiSh,R,rtabaga,Salsify,S"""Ipolalo.Tanier.Tum{>,Yams),Soybeans,StoneFruits:(I\p!icots,Chernes(s,.,eetemNectarines.Pooches,Plums(Ch":k"""'N,Damson,J[ljJaoosePrune,),TobaccoaridTomatoes.2.SeedTreat"",nlUses:Cam:>ts,Cotton.PeanulS,Soybeans.Sorghum,Sp;-,acI1,Sunn""",rs,GardenBeets,SugarBeets,ForageLeg..nes(Malia,Clover.Lespedeu.,Beans101Fomge,torFomgc,So)'beanHay,Peanul.forFornge,PeanufHay,Peas101F,""gc,PeaVineHay,Co""",,,forFomge,CowpeaHay.TrefoilVeld"andVel>'elBeansforForage),GrainCrOps(Wleat,Barley.Rye,Oals,Mile!.Milo,FieldCom,S""elCorn;Popcorn.Buck'Mleat.andTrilicale),Rice,SeedandPodVegetaJles(Blfl(;k.E:,-edPeas,Chickpeas,Garbat12os.COWpeas,Oill,Ed,bleSoybeans.FieldBeans.FieldPeas,GardenPeas,GreenBeans,KId.-.eyBoons,LimaBea"s,Lupines,Na-.yBeans,Okra.Peas,PoleBeans,SnapBeans,SlnngBeans,WaxBeans,andLenWs),Peas,Cucumbers.TunGrasses.andForageGrasses.J.ForExportUses:CuwobitVegetables,FrullingVegetables,LeafyVegetables.Brassica(Cole)LeafyVeget.:lble.,RootandTuberveget:>bles,Onions,COOl,Mllet.Pea••SOfIJhum,andSLJ/lIIowenl.4.T"""striaINonfoodUses:Turfusesoncourses,lawnsandtarldscapeareasaroumre.!denlial,publk:,commer"a1andindustntllbuildings,perks,recreationalareasaridfields,use$onornamentalsgrov.<1inconlainer.bench.1IaI,plug,!>edorinIhefield,mgreenhouses,shadehouses,oul"""rr"OJrseries,retailnurseries,InteOorscapes,aridotherlandsca""area$.5.Usesforwh.,htheUSEPAhasacceptedthereqUireddataand'orcitationsofdatathatthefonnu!a1Orh.,.submittedinsupport01and6.UsesforexperimentalpurposesthafareIncomplia",:ewithUSEPArequirementsSTORAGEANODISPOSALDONOTcontaminatev.ster.foodorteedbystOffigcordispMal,PESTICIDESTORAGE:NwaysuseoIiginaicontainertoslorepestlCJdesinarooI,doysecured",arehooseorstoragebulding,00NOTsloreneartoodandfeed.Containersshooldbeopened,nareas.KeepcootaineIsealed;oJ,<mnolinuse.;PESTICIDEDlS?OSAL:OpendumpingisprDl1ibited.wastesresultingfrom!heuseof,thisproductmaybedisposedofonsiteoratanapprovedWilsiedispMalfm:JEty.ICONTAlNERDISPOSAL:PlasticorPaperBogs:Noomfilablacontainer.DONOTrruseorrefilU1ISCO<ItaO-ler.Completelyemptybagintomanulactunngequipment.OfferlormoydlngavailableOrdisposeofemptybaginasanitaoylandfillorPI'it1dnerallon.or,ifalov.edpyslale,.-,d1<!CaIa",>-,omias,bybuming.Itburned,slayootofsm<i:e,NOTREVIEWEDInAccordancewithPRNotice82-2BasedonDraftLabelingDated7/0DPlosli<:Containers:conlainer:DONOTreuseorm!illthisconl1lil1er.TriplennSe(orequ;"alenl)promptlyaflerempt,;ng.Emptytheremainingcontentsinloapplicationequipmenloramt:<tankanddraintor10secondsaftsrthenovrbegin.10drip.Fimthecontainerfl4full"';Ihv.aterandre<:«l.St>akefortosecorlds.Poormsmeinloappllca:ionequipmentoramt:<tanl\or810'"rirlSaCetorlateruseordisposal.Drainfor10"""""dsaflerthe!lowt>eginstodnp.RepeatthisprocedureMI>moretimes.ThenI,..recydingorfeCOIlditioning.,..punctureMddi.poseotinasanrtaryI"mllm,orbyotherprocedlJl"eSapprovedbySialearujkJcaIaulholities.PlasliccontainersarealsodisposablebyindooraUon.or,ifbyStateandlocalbyburning.Itburned,stayoutofsmoke.Fiberdrumsliners:Nonrefilableconlainer,DONOTreuseOrrefillhiscontainer.Complelelyempty"ncrbyshal<ingaridtappingbothsiclesandbollomtoloosendrogingpaotides.EmptyresidueinlomanuractunngequipmentThenofferrIDerdrumMdImer1mrocyding,fa\o'ai"ble.WARRANTYDISClAIMERTIwdirectionsforuse01li,lspruducImustbefollowedcarefully.TOTHEEXTENTCONSISTENTWITHAPPLICABLElAW,(1)THEGOODSDELiVEREOTOYOUAREFURNISHEO"ASIS"BYMANUFACTURERORSEl.L.E'RAND(2)MANUFACTURERANOSELLERMAKENOWARRANTIES,GUARANTEES,ORREPRESENTAUONSOFANYKINDTOBIJ'fERORUSER,EITHEREXPRESSORIMPLlEO,ORBYUSAGEOFTRAOE,STATUTORYOROTHERWISE,WITHREGAROTOTHEPRODUCTSOLO,INUUOING,BUTNOTLlMiTEOTOMERCHANTABILITY,ATtESSFORAPARTICUlARPURPOSE,USE,ORELIGIBILITYOFTHEPRODUCTFORANYPARTICUIARTRADEUSAGE.UNINTENOEOCONSEOUENCES,INCLUOINGBUTNOTLlMITEOTOINEFFECTIVENESS,MAYRESULTBECAUSEOFSUCHFACTORS!>STHEPRESENCEORABSENCEOFon-IERMATERIALSUSEDINCOMBINATIONWITHTHEGOODS.ORTHEOFUSEORAPPLICATION,INCLUDlNGWEATHER,ALLOFWHICHAREBEYONOTHECONTROLOFMANUFACTURERORSELLERANOASSUMEOBYBUYERORUSER.THISVIoRITINGCONTAINSAlLOFTHEREPRESENTATIONSANDAGREEMENTSBETVIIEENBIJ'fER,MANUFACTURERANDSELLER,ANONOPERSONORAGENTOFMANUFACTURERORSELLERHASAfNAUTHORITYTOMAKEANYREPRESENTATIONORWARRANTYORAGREEMENTRELATINGINA'INWAYTOTHESEGODDS.LIMITATIONOFLlA81L1TYTOTHEEXTENTCONSISTENTWITHAPPLICABLELAW,INNOEVENTSHALLMANUFACTURERORSELLERBELIABLEFORSPECIAl,INCIOENTAl,ORCONSEQUENTIALDAMAGES.ORFORDAMAGESINTHEIRNATUREOFPENALTIESRELATINGTOTHEGOODSSOLO,INCLUOiNGUSE.APPLICATION.w.N{lLlNG,ANOOISPOSAL.TOTHEEXTENTCONSISTENT1MTl-!APPUCABLELAW.MANUFACTURERORSELLERSHALLNOTBEUABLETOBUYERORUSER8YlA'AYOFINDEMNIFICATIONTOBUYERORTOCUSTOMERSOFBUYER,IFANY,ORFOPANYOAMAGESORSUMSOFCl.AJMSOROEMANDSRESULTINGFROMORBYREASONOF.ORRISINGOUTOFTHEMISUSE,ORFAILURETOFOLLOWlABELWARNINGSORINSTRUCTIONSFORUSE,OFTHEGOOOSSOLOBYMANUFACTURERORSELLERTOBUYER.TOTHEEXTENTCONSISTENTWlTl-!APPLICABLELAW,ALLSUCHRISKSSHALLBEASSUMEOBYTHEBIJ'fER,USER,ORITSCUSTOMERS.TOTHEEXTENTCONSISTENTIMTHAPPLICABLELAW.BUYER'SORUSER'SEXCLUSNEREMEOY,/lNOMANUFACTURERSORSELLER'STOTALLlAEllLiTYSHALLBEFOROAMAGESNOTEXCEEOINGTHECOSTOFTHEPROClUCT,Ifyoudonolagreewilhordonolacceplany01directionsforuse,thewarrantydisclaimers,orlimitationsonliability,donotlISetheproduct,andreturnitunopened10IheSeller,andIhepurchasepriC!!willbe",Iunded.Product01ChinaNETWEIGHT:55.11Lbs.(25.0Kg)M;onllfactun>dforNUFARMLIMITED104T.W.Alox:ondllrDrive,Bldg.5TriangloPar1<,No:27709(RV072ffO)III"-mo:

# Expand M2**~**



# t

'iJ.-...

### f-.'l1J~

# ~ Set up instructions



# I

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# . I 

# j 

# I**\~l** I

# ~UU**----~~-.~~** 

### ..**~-** 

### ..**-'-~.-.--'.~. ..~,**  

### ..**~** ' 

### ..

Patpend,



# w"=**=~"="""'====:iil="iiI.**

.. Keep media roll tightly wound



### • The top profile should be in the position pictured below

.. Place hollow end of media roll on to left side connector knob

.. Then place the right side of the media roll with the metal pin



### into the locking slot



# I;l[<'l:pd**l~ir.HM** 

# lfIJ**JL~** 

# 1

• 

# 2

Engage locking tab

by pushing it inwards

.



# 3

Close front section

.

"'M"""_.

®

# Material to be added to an e-Jacket/Jacket

Reg. No. 

# 35"" Cj3S;

# ~ 

# 7?

Description: 

# GhL.**~{r'\J!AtdID~** JYfZS;)50

1. [);I 

# Placement within the e-Jacket/jacket:



# Eil Default: (chronological, top 

# = newest)

D 

# File 

# Location: (PDF page number, i.e., "before page



# 45")

2. ipJ Send to Data Extraction contractors this material:**~** 

# Newly stamped accepted label

D 

# Notification

I)1l 

# New CSF

ili 

# Other: 

# rLl

t..

........

# ~ t:.

# ~**\~I''\t** 

# ,

3. Attach this coversheet to the top of the material or jacket. It

must be well organized and clipped together, NOT STAPLED.

Then give the material with this coversheet to staff in the

Information Services Center (Room S-4900).



# Reviewer's Name: 

# R OBC'Q\ 

# WfS:1I1V



# Phone:**7u~-3DS-~7~1** 

# Division: 

# Wig

Date: 

# 'J 

# v...\",

L. \, 

# Z (,J 

# 0**"<5---~**



## Created August 

## 19, 2008

## ~~,"O 

# ".'" U.S. ENVIRONMENTAL PROTECTION AGENCY EPA Reg. Number: Date of



### Issuance: 

# ",. Q

"7' 

### Office of Chemical Safety and Pollution Prevention 

# 35935-79 

# JUL**;~** 

# J 2(**~** 

# 'i Office of Pesticide Programs



### i

## ~ 

# t:: Registration Division {7504P)

\,

## ~'« 1200 Pennsylvania Ave., N.W.

Term oflssuance:

\<'4')- 

### 0,,-,,0 Washington, DC 20460

4t**PRO~~** 

## Conditional 

# o

NOTICE OF PESTICIDE:

2L Registration Name of Pesticide Product:



## _Reregistration 

# Metalaxyl Technical

(under FIFRA, as amended)

Name and Address of Registrant (include ZIP Code): 

### Mailed to: 

# Nufarm Limited Nathan P. Ehresman



# PO Box 13439 Director, Regulatory Affairs



# RTP, North Carolina 27709 Nufarm Americas, Inc.

501 Cascade Pointe Lane, Suite 103

Cary, NC 27513

Note: 

## Changes inJab(!ling diffeiingin 

## substance from',that accepted**ini:c:mn~'<:t:i0n** 

## with 

## this registration 

## mu'st



## be submitted to and accepted by the' Registration'Division prior to"use'of theJilbel,in commerce. ,In any correspondence ,on this product' always refer to'the above: EPA registration'number: '

On the basis of information furnished by the registrant, the above named pesticide is

hereby registered under the Federal Insecticide, Fungicide and Rodenticide Act.

Registration is in no way to be construed as an endorsement or recommendation of this

product by the Agency. In order to protect health and the environment, the Administrator,

on his motion, may at anytime suspend or cancel the 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 not 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:

!. 

## Submit and/or cite all data required for registration of your product under FlFRA

sec 3( c)(S) when the Agency requires all registrants of similar products to submit

such data; and submit acceptable responses required for reregistration of your

product under F1FRA section 4.

Pa,ge 1 of 2

Signature of Approving Official: Date: 

# 71h cI**{i)ffi~** 

# 7/c2 I!J- () (()

Mary L. Waller, Product Manager (21)

Fungicide Branch/Registration Division/OPP /OCSPP [7504P)

EPA Form 8570-6

# Notice of Pesticide Registration

Metalaxyl Technical 

# .JUL ;; j 

# 20iO

EPA Reg. No. 35935-79



# Page2of2

2, You must submit the following conditional data within 18 months of the date of this

registration:

a. Storage Stability (830.6317) and Corrosion Characteristics (830.6320)



# studies.

3. Make the following changes to the label:

a, Delete the box from around the Signal Word on page 1

b. Change the product registration number to "EPA Reg. No.**35935~79"**



## c. On page 2 in the section HAZARDS TO HUMANS & 

## DOMESTIC ANIMALS



# add the following after the sentence "Harmful if swallowed or absorbed

through the skin": "Wear goggles or face shield."

d, On page 2 in the second line from the bottom add a comma between Napa

and Bok choy.

e. On page 4 in the section LIMITATION OF LIABILITY change "ALL SUCH

RISKS SHALL BE ASSUMED BY THE BUyER

.... " to "TO THE EXTENT

CONSISTENT WITH APPLICABLE LAW, ALL SUCH RISKS SHALL BE

ASSUMED BY THE BUyER

.... "



# 4. Submit one copy of the revised final printed label for the record 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 ofthe product

constitutes acceptance ofthese conditions.

A copy of the label stamped "Accepted with Comments" is enclosed for your records.

Enclosure:

Label stamped "Accepted with Comments"

# 17?r;c/to~

Mary 

## L. Waller

Product Manager (21)



# Fungicide Branch

Registration Division (7504P)



# Memorandum -Impurities Discussion for New Formulation, DP372875 dated May

20,2010

# METALAXYL TECHNICAL

FOR MANUFACTURING USE ONLY

ACTIVE INGREDIENT:

Metalaxyl: N-(2,6-dimethylpheny)-N-(methoxyacetyl)-alanine methyl 

## ester

......................... 

## 97.0%

OTHER INGREDIENTS:

.............................................................................................................. 3.0%

TOTAL:

.................... 100.0%

KEEP OUT OF REACH OF CHILDREN 

# WARNING

For Chemical Spill, Leak, Fire, or Exposure, Call CHEMTREC (800) 424-9300

For Medical Emergencies Only, Call (877) 325-1840



### EPA REG. NO. 35935·TO

EPA EST. NO.

____ _ 

# ACmmD

with 

# COl\l!llliW'S

In EPA Le\t$r 

## nated



# ;' i 20m

UnderIhoF_- 

# _...1_""

as**~.** 

## fOl' the poatidde

## ~~n...NO. 

# ::J 

# 7gq

_

MANUFACTURED FOR

NUFARM Limited

Research Triangle Park, NC 27709



## NET CONTENTS LBS. (

__ KG)

035935-000TO.201 00528.Revised _Draft

## PRECAUTIONARY STATEMENTS

HAZARDS TO HUMANS 

## & DOMESTIC ANIMALS



# WARNING

Causes substantial but temporary eye irritation. Harmful if 

## swallowed or absorbed through the skin. DO

NOT get in eyes or on clothing. Wash thoroughly after handling. Remove contaminated clothing and wash



## before reuse.

FIRST AID

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:

eye.



## Call a poison control center or doctor for 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**o~** 

## doctor. '



## DO NOT give anything 

## by mouth to an unconscious person.

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.

Move person to fresh air.

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

preferably mouth-to- mouth if possible.

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

HOT LINE NUMBER

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

treatment. You may also contact 1-877-325- t840 for emergency medical treatment information.

ENVIRONMENTAL HAZARDS

DO NOT discharge effluent containing this product 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 EPA.

DIRECTIONS FOR USE

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

This product is intended for the formulation of fungicide products. This product may be used to formulate

products for specific use(s) not listed on the MP label if the formulator, user group, or grower has complied

with the U.S. EPA data submission requirements regarding the support of such use(s).

FOR MANUFACTURING USE ONLY AS A FUNGICIDE FOR THE FOLLOWING USES:

1) Terrestrial Food Crops including Home Gardens and QrC','lards: J\lfalfa, Birdfoot trefoil, Apples,

Asparagus, Avocados, Berries: (Blueberries, Cranberries;'**Ra3jJb.::r~ies,** 

## Strawberries), Cassava,

Citrus: (Citrus citron, Grapefruit, Kumquats, Lemons, Limes, Oranges, Tangelos, Tangerines and all

hybrids of these), Cole Crops: (Broccoli, Cabbage, CauliflO\Aler,**(:hines~** 

## brnccoli, Gar lon, White

flowering broccoli, Chinese cabbage (Napa. Bok C'loy), Cotton, Cucurcits: (Balsam pear, Chinese

waxgourd, Citron melon, Cucumber, Gherkin, Edible**gou~d::;,** 

## CantaloL.;pe:., Casaba, Crenshaw,

Page 2 of6

## Honeydew melon, Honey balls, Mango melon, Muskmelon, Persian melon, Pumpkin, Summer

squash, Winter squash, Watermelon, and Cucurbits hybrids), Ginseng, Hops, Leafy Vegetables:

(Head Lettuce, Spinach), Legume Vegetables (Succulent or Dried): (Field beans, Lima beans, Mung

beans, Navy beans, Pinto beans, Runner beans, Snap beans, Wax beans, Broad beans (Fava

beans), Chickpeas (Garbanzo beans), Lentils, Lupines (Sweet, White sweet, White and Grain),

Garden peas, Field peas, Sugar peas, Southem peas (Black-eyed peas, Crowder peas, Cowpeas,

Catjang) and Edible soybeans, Onions: (Dry bulb, Green Onions, Spring onions or Scallions,

Japanese bunching onions, Green shallots or Green eschalots. Leeks), Nut trees: (Almond and

Walnuts), Papaya, Peanuts, Peppers and Eggplant, Pineapple, Root and Tuber Vegetables:

(Jerusalem artichoke, Beet (Sugar and Table), Carrot, Cassava, Chicory, Ginger, Horseradish,

Parsnip, Potato, Radish, Rutabaga, Salsify, Sweet potato, Tanier, Turnip, Yams), Soybeans, Stone

Fruits: (Apricots, Cherries (Sweet and Sour), Nectarines, Peaches, Plums (Chickasaw, Damson,

Japanese Prunes), Tobacco and Tomatoes.

2) Seed Treatment Uses: Carrots, Cotton, Peanuts, Soybeans, Sorghum, Spinach, Sunflowers, Garden

Beets, Sugar Beets, Forage Legumes (Alfalfa, Clover, Lespedeza, Beans for Forage, Soybeans for

Forage, Soybean Hay, Peanuts for Forage, Peanut Hay, Peas for Forage, Pea Vine Hay, Cowpeas for

Forage, Cowpea Hay, Trefoil, Vetch, and Velvet Beans for Forage), Grain Crops (Wheat, Barley,

Rye, Oats, Millet, Milo, Field Com, Sweet Corn; Popcorn, Buckwheat, and Triticale), Rice, Seed and

Pod Vegetables (Black-Eyed Peas, Chickpeas, Garbanzos, Cowpeas, Dill, Edible Soybeans, Field

Beans, Field Peas, Garden Peas, Green Beans, Kidney Beans, Lima Beans, Lupines, Navy Beans,

Okra, Peas, Pole Beans, Snap Beans, String Beans, Wax Beans, and Lentils), Peas, Cucumbers,

Turf Grasses, and Forage Grasses.

3) For Export Uses: Cucurbit Vegetables, Fruiting Vegetables, Leafy Vegetables, Brassica (Cole)

Leafy Vegetables, Root and Tuber Vegetables, Onions, Corn, Millet, Peas, Sorghum, and

Sunflowers.

4) Terrestrial Nonfood Uses: Golf course turf, lawns and landscape areas around residential,

institutional, public, commercial and industrial buildings, parks, recreational areas and athletic fields,

uses on ornamentals grown in container, bench, flat, plug, bed or in the field, in greenhouses, shade

houses, outdoor nurseries, retail nurseries, interiorscapes, and other landscape areas.

5) Uses for which the US EPA has accepted the required data and/or citations of data that the formulator

has submitted in support of registration; and

6} Uses for experimental purposes that are in compliance with US EPA requirements.

Page 3 of6

## STORAGE AND DISPOSAL



## DO NOT contaminate water, food, or feed by storage and disposal.

PESTICIDE STORAGE: Always use original container to store pesticides in a cool, dry secured warehouse or

storage building. DO NOT store near food and feed. Containers should be opened in well-ventilated areas. Keep

container 

## tightly sealed when not in use.



## PESTICIDE DISPOSAL: Open dumping is prohibited. Wastes resulting from the use of this product may be

disposed of on site or at an approved waste disposal facility.

CONTAINER DISPOSAL:



## For Plastic or Paper Bags: Nonrefillable container. DO NOT reuse or refill this container. Completely empty

bag into manufacturing equipment. Offer for recycling 

## if available or dispose of empty bag in a sanitary landfill or 

## by incineration, or, 

## if allowed 

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

Plastic Containers: Nonrefillable container: DO NOT reuse or refill this container. Triple rinse (or equivalent)

promptly after emptying. Empty the remaining contents into application equipment or a mix tank and drain for 10

seconds after the flow begins to drip. Fill the container **1/4** 

## full with water and recap. Shake for 10 seconds. Pour

rinsate into application equipment or a mix tank or store rinsate for later use or disposal. Drain for 10 seconds

after the flow begins to drip. Repeat this procedure two more times. Then offer for recycling or reconditioning, or

puncture and dispose of in a sanitary landfill, or by other procedures approved by State and local authorities.

Plastic containers are also disposable by incineration, or, if allowed by State and local authorities, by burning. If

burned, stay out of smoke.

Fiber drums with liners: Nonrefillable container. DO NOT reuse or refill this container. Completely empty liner

by shaking and tapping both sides and bottom to loosen clinging particles. Empty residue into manufacturing

equipment. Then offer fiber drum and liner for recycling, 

## if available.

WARRANTY DISCLAIMER



## The directions for use of this product must 

## be followed carefully. TO THE EXTENT CONSISTENT WITH

APPLICABLE LAW, (1) THE GOODS DELIVERED TO YOU ARE FURNISHED "AS IS" BY MANUFACTURER

OR SELLER AND (2) MANUFACTURER AND SELLER MAKE NO WARRANTIES, GUARANTEES, OR

REPRESENTATIONS OF ANY KIND TO BUYER OR USER, EITHER EXPRESS OR IMPLIED, OR BY USAGE

OF TRADE, STATUTORY OR OTHERWISE, WITH REGARD TO THE PRODUCT SOLD, INCLUDING, BUT

NOT LIMITED TO MERCHANT ABILITY, FITNESS FOR A PARTICULAR PURPOSE, USE, OR ELIGIBILITY OF

THE PRODUCT FOR ANY PARTICULAR TRADE USAGE, UNINTENDED CONSEQUENCES, INCLUDING

BUT NOT LIMITED TO INEFFECTIVENESS, MAY RESULT BECAUSE OF SUCH FACTORS AS THE

PRESENCE OR ABSENCE OF OTHER MATERIALS USED IN COMBINATION WITH THE GOODS, OR THE

MANNER OF USE OR APPLICATION,INCLUDING WEATHER, ALL OF WHICH ARE BEYOND THE CONTROL

OF MANUFACTURER OR SELLER AND ASSUMED BY BUYER OR USER. THIS WRITING CONTAINS ALL OF

THE REPRESENTATIONS AND AGREEMENTS BETWEEN BUYER. MANUFACTURER AND SELLER, AND

NO PERSON OR AGENT OF MANUFACTURER OR SELLER HAS ANY AUTHORITY TO MAKE ANY

REPRESENTATION OR WARRANTY OR AGREEMENT RELATING IN ANY WAY TO THESE GOODS,

LIMITATION OF LIABILITY

TO THE EXTENT CONSISTENT \MTH APPLICABLE LAW, IN NO EVENT SHALL MANUFACTURER OR

SELLER BE LIABLE FOR SPECIAL, INCIDENTAL, OR CONSEQUENTIAL DAMAGES, OR FOR DAMAGES IN

THEIR NATURE OF PENALTIES RELATING TO THE GOODS SOLD, INCLUDING USE, APPLICATION,

HANDLING, AND DISPOSAL, TO THE EXTENT CONSISTENT \MTH APPLICABLE LAW, MANUFACTURER

OR SELLER SHALL NOT BE LIABLE TO BUYER OR USER BYWAY OF INDEMNIFICATION TO BUYER OR TO

CUSTOMERS OF BUYER, IF ANY, OR FOR ANY DAMAGES OR SUMS OF MONEY, CLAIMS OR DEMANDS

WHATSOEVER, RESULTING FROM OR BY REASON OF, OR RISIt<:G OUT OF THE MISUSE, OR FAILURE TO

FOLLOW LABEL WARNINGS OR INSTRUCTIONS FOR USE, OF**"l-I~'3()0[)~** 

## SOLD BY MANUFACTURER

OR SELLER TO BUYER. ALL SUCH RISKS SHALL BE ASSUMED BY THE BUYER, USER, OR ITS

CUSTOMERS, TO THE EXTENT CONSISTENT WITH APPLICABLE LAW, BUYER'S OR USER'S EXCLUSIVE

REMEDY, AND MANUFACTURER'S OR SELLER'S TOTAL I.IABIU-;-V 3fiALL aE FOR DAMAGES NOT

EXCEEDING THE COST OF THE PRODUCT,



## Page 4 of 6

## If you do not agree with or do not accept any of directions for use, the warranty disclaimers, or limitations

on liability, do not use the product, and return it unopened to the Seller, and the purchase price will be

refunded.

(RV052810)

Page 5 of6

## Re: Label deficiency

- Metalaxyl Technical EPA File Symbol 35935- TO

nathan.ehresman

to:

Robert Westin



## 05/28/201002:32 

## PM

Show Details

Nathan P. Ehresman

Director, Regulatory Affairs

Nufarm Americas, Inc.

501 Cascade Pointe Lane, Suite 103

Cary, NC 27513



## Phone: 919.655.0018

Fax: 919.342.5176

Mobile: 630.418.6035

nathan.ehresman@us.nufarm.com

From: Weslin.Robert@epamail.epa.gov

To: nathan.ehresman@us.nufarm.com

Dale: **05/2812010** 11 :00 AM

Subject: label deficiency

- Metalaxyl Technical EPA File Symbol 35935-TO 

# 51?

) 0 

# b

P 

## Page 1 of2



# 5:;**~~**



# "c : d'

,**~** ('i[At'**~~~O"$$7,~~g~7~~% "'_=,~~~_~=~~~$~~~N$=g~V_=~_~_~_-=-="",,",~_~~~=_** 



## Re: Your application for pesticide registration dated 12/16/2009



## EPA Decision Number 425256

Dear Mr. Ehresman:

The draft label submitted with your application for product registration is not acceptable. The

following changes are required:

1. On page 2 in the list of Terrestrial Food Crops delete "Loquat"

2. On page 3 in the list of Terrestrial Nonfood Uses change "Uses on golf courses,

lawns

.... " to "Turf uses on golf courses, lawns

.... "

3. In the STORAGE AND DISPOSAL box revise the CONTAINER DISPOSAL instructions

to comply with the requirements of Pesticide Registration Notice 2007-4.

4. Reformat the draft label using a larger font size so thst the i;nug"d accepted label will be

legible on the Agency's PPLS web site. It is recommended tnat ti.'e t"inimum font size be 11

point Arial.

Please email me a .pdf file of the revised draft label.

Please call me if you have any questions.

Robert Westin

file:IIC:\Documents 

## and SettingslrwestinlLocal SettingsITemplnotesFCBCEEI-web7766.h... 5/28/2010

## phone:

FAX:



## email: 

# 703-305-5721

703-305-6920

westin.robert@epamail.epa.gov



# ***************************************************** Page 2 of2

THIS MESSAGE IS INTENDED ONLY FOR THE USE OF THE INDIVIDUAL OR ENTITY TO

WHICH IT IS ADDRESSED AND MAY CONTAIN INFORMATION THAT IS PRIVILEGED,

CONFIDENTIAL AND EXEMPT FROM DISCLOSURE. If the reader of this message is not the



## intended recipient or an employee or agent responsible for delivering the message to this intended

recipient, you are hereby notified that any dissemination, distribution, or copying of this 

## communication

is strictly prohibited. If 

## you 

## have received this communication in error, please delete, destroy, and do

not save the message.



## Nufarm Americas Inc. and its affiliated companies.

Fax: +1 630455 200l.

file://C:\Documents and Settings\rwestin\Local Settings\Temp\notesFCBCEE\-web7766.h

... **5/28/2010**

## Re: Metalaxyl Technical EPA 

## File Symbol 35935-TO

nathan.ehresman

to:

Robert Westin



## 05/28/201011:23 

## AM

Show Details

I'll get the changes to you shortly. Thank you

Nathan P. Ehresman

Director, Regulatory Affairs

Nufarm Americas, Inc.

501 

## Cascade Pointe Lane, Suite 103



## Cary, NC 27513



## Phone: 919.655.0018



## Fax: 919.342.5176



## Mobile: 630.418.6035



## nathan.ehresman@us.nufarm.com

From: Wes!in.Robert@epamail.epa.gov

To: nalhan.ehresman@us.nufarm.oom

Oate. 051281201011:21 AM

Subject Metalaxyl Technical EPA File Symbol 35935-TO



## EPA Decision Number 425256



## A couple more changes needed to the 12/16/09 

## draft label: Page 1 

## of 1



# (;**;;;J:::;~**

1. 

## In the section HAZARDS TO HUMANS AND DOMESTIC ANIMALS change "Causes eye irrnation" to "Causes

substantial but temporary eye injury."

2. 

## In the FIRST AID box move the IF IN EYES instructions to the top of the list.

Robert Westin

phone: 703-305-5721

FAX: 703-305-6920



## email: westin.robert@epamail.epa.gov



# *****************************************************

THIS MESSAGE IS INTENDED ONLY FOR THE USE OF THE INDIViDUAL OR ENTITY TO WHICH IT IS

ADDRESSED AND MAY CONTAIN INFORMATION THAT IS PRIVILEGED, CONFiDENTIAL AND

EXEMPT FROM DISCLOSURE. If the reader of this message is not the intended recipient or an employee or

agent responsible for delivering the message to this intended recipient, you are hereby notified that any

dissemination, distribution, or copying of this communication is strictly prohibited. If you have received this

communication in error, please delete, destroy, and do not save the message.

Nufarm Americas Inc. and its affiliated companies.

Fax: 

## + I 630 455 200 I.



## file:IIC:\Documents 

## and Settings\rwestin\Local Settings\Temp\notesFCBCEE\-web41 OO.h... 5/28/2010**~_:,o,.;;,,;;** 

### j 

# ft.,**~~~.**

### ~,@ifk4'1

# ~ Metalaxyl Technical EPA File Symbol 35935- TO

Robert Westin to: nathan.ehresman

Bee: Robert Westin



### EPA Decision Number 425256

A couple more changes needed to the 

## 12/16/09 draft label: 05/28/20101 

### t:21 AM



### 1. In the section HAZARDS TO HUMANS AND DOMESTIC ANIMALS change "Causes eye irritation" to

"Causes substantial but temporary eye injury."



### 2. In the FIRST AID box move the IF IN EYES instructions to the top of the list.

Robert Westin



### phone: 703-305-5721

FAX: 703-305-6920



### email: westin.robert@epamail.epa.goY

# .;;.:.>1..

{ •. -Ji**~** Label deficiency

- Metalaxyl Technical EPA File Symbol 35935- TO

Robert Westin 

## to: nathan.ehresman **05/28/2010** 

## 11 :00 AM

Bee: Robert Westin

,,',.

, 

### .... , 

### ...... , 

### .. , 

### ........ , 

### ...................... .



## Re: Your application for pesticide registration dated 12/16/2009



## EPA Decision Number 425256

Dear Mr. Ehresman:

The draft label submitted with your application for product registration is not acceptable,

The following changes are required:

1. On page 2 in the list of Terrestrial Food Crops delete "Loquat"

2, On page 3 in the list of Terrestrial Nonfood Uses change "Uses on golf courses,

lawns

.... " to "Turf uses on golf courses, lawns

.... "

3, In the STORAGE AND DISPOSAL box revise the CONTAINER DISPOSAL

instructions to comply with the requirements of Pesticide Registration Notice

2007·4,

4. Reformat the draft label using a larger font size so that the imaged accepted label

will be legible on the Agency's PPLS web site. It is recommended that the minimum

font size be 11 point AriaL

Please email me a ,pdf file of the revised draft labeL

Please call me 

## jf you have any questions.



## Robert Westin

phone:

FAX:



## email: 703-305-5721

703-305-6920

westin,robert@epamail,epa.gov

## Re: Data Matrix deficiency

- MetalaxyI Technical

t



## nathan.ehresman 0 

## Robert Westin

Nathan P. Ehresman

Director, Regulatory Affairs



## Nufarm Americas, Inc.

501 Cascade Pointe Lane, Suite 103

Cary, NC 27513

Phone: 919.655.0018

Fax: 919.342.5176

Mobile: 630.418.6035



### natha n. eh resma n@us.nufarm.com

From: Weslln.Robert@epamail.epa.gov

To: nathan.ehresman@us.nufarm.com

Dale: 

### 05/27/201009:53 AM

Subject: Data Matrix deficiency

- Metalaxyl Technical



## re: Your application for pesticide registration dated 12/16/09



## EPA File Symbol 35935-TO

EPA Decision Number 398450

Mr. Ehresman:**/.~** 

# '1;- 

# en "1 

## ,'" ,;)::JvC(.



# -

**05/27/201004:58** 

### PM



## The data matrix dated 12/16/2009 

## does not list all of the metalaxyl data submitters that

are listed on the Pesticide Data Submitters List dated March 31, 2010. For a cite-all

data matrix, offer to pay letters must be submitted to all of the currently listed data

submitters and their names and addresses must appear on the data matrix.



## The following data submitters are not listed on your data matrix

E.I. 

## DuPont

- company number 352

BASF Corporation

- company number 7969

Albaugh Inc

- company number 42750

Phoenix Environmental Care

- company number 81943

## Please submit a revised data matrix and form 8570-34 (Certification with Respect to

Citation of Data)

Robert Westin

phone:

FAX:

email: 703-305-5721

703-305-6920

westin.robert@epamail.epa.gov



# *****************************************************

THIS MESSAGE IS INTENDED ONLY FOR THE USE OF THE INDIVIDUAL OR ENTITY

TO WHICH IT IS ADDRESSED AND MAY CONTAIN INFORMATION THAT IS

PRlVILEGED. CONFIDENTIAL AND EXEMPT FROM DISCLOSURE. If the reader of this

message is not the intended recipient or an employee or agent responsible for delivering the

message to this intended recipient, you are hereby notified that any dissemination, distribution, or

copying of this communication-is strictly prohibited. If you have received this communication in

error, please delete, destroy, and do not save the message.

Nufann Americas Inc. and its affiliated companies. 

# "'to

Fax: +1 630455 2001. 035835·000TO.20100527.8570-35_(Matrix_Public).pdf 

# "'t "'t

035835-000T0.201 00527.8570-34_ CertwR 

### TeD. pdf 

### 035835-000ro .201 00527. 8570·35_(Matrix_AgencY)'I-,LI' '

# , 

# ..,. 0' UNITED STATES ENVIRONMENTAL PROTECTION AGENCY



## 401 M Street, S.W.

WASHINGTON, D.C. 20460

Paperwork Reduction Act Notice: The public reporting burden for this collection of information is estimated to average 1.25 hours per



### response for registration activities and 

### 0.25 hours per response for reregistration and special review activities, including time for reading

the instructions and completirrg the necessary forms. Send comments regarding the burden estimate or any other aspect of this collection

of information. including suggestions for reduCing the burden to: Director, OPPE Information Management Division (2137), U.s.

Environmental Protection Agency, 401 M Street. SW .• Washington, DC 20450. Do not send the follT1 to this address.



### Certification with Respect to Citation of Data



### Nufarm Limited, PO Box 13439. Research Triangle Park, 27709

Metalaxyl (PC code 113501)

General use pattem(s) (list all those claimed for this product using

40 CFR Part 158)

Terrestrial food crop; Terrestrial EPA Registration Number/ File Symbol



### 35935-TO

Date

2010

Product Name

Metalaxyl Technical

NOTE: If your product is a 

### 1000/0 repackaging 

### of another purchased EPA-registered product labeled for all the same uses on

your label, you do not need to submit this form. You must submit the Formulator's Exemption Statement (EPA Form 8570-27).



# o lam to a Data Calf-In Notice, and have included with this form a list of companies sent offers of



# o I am using the cite-all method of support, and have

included with this form a list of companies sent

offers of compensation (the Data Matrix form I am using the selective method 

### of support (or cite-all option

under the selective method), and have included with this form a

completed list of data reQuirements (the Data Matr;).. f'),m must



### be

(Required if using the cite-all method or when using the cite-all option under the selective method'(v'Jut;sfy one or I'r'i.)re data

requirementsi ' "



# !8l I hereby offer and agree to pay compensation, to other persons, with regard 10 the approval ofIris at"lpllcation, to rhe



### »c

..... I 'Uri Ill;

..... 

### cr. I 

# U·'

..... A I ,

I certify that this application for registration, this form for reregiStration, or t

submitted or**c~ed** in the application for registration, the form for reregistration, or this Data Call-In response. In addition, tf 7:r·",I' r:plion

under the selective method is indicaled in Section I, this applicalion is supported by all data in the Agency's fites that (t) cOolcern the

propenies or effeets 

### of thIS product or an identical or subslantially similar product, or one or more of the ingredients in this pr 

### .X:lC:; and (2)

is a type of data that would be required 

### to be submitted under the data requirements in effect on the date of approval of this ,"lrrlir;ation if

the application sought the initial registration of a product of identical or similar compos.ition and uses.

I certify that for each exclusive use study cited In support of this registration or reregiStration, that I am the original submitter or

that I have obtained the written permission of Ihe original submitter to cile that study_

I certify that for each stUdy cited in support of this registration or reregistration that is not an exclusive use study, either: (a) I am

the original data submitter; (b) I have obtained the written permission of the original data submitter to use this study in support of this

application; (c) all periods of eligibility for compensation have expired for tne study; (d) the study is in the public literature; or (e) I have

notified in writing the company that submitted the study and have offered (i) to pay compensation to the extent required by sections

3(c)( t){F) andJor 3(c){2)(B) of FIFRA; and (ii) to commence negotiations to determine the amount and terms 

### of compensation, if any, to be

paid for the use of the study.

I certify that In all instances wl1ere an offer of compensation is required, copies of all offers 

### to pay compensation and evidence of

their delivery in accordance with sections 3(c)(t){F) and/or 3(c)(2){B) of FIFRA are available and will be submitted to the agency upon

request. Should I fail to produce such evidence 

### to the Agency upon request. I understand that the Agency rrnly initiate action to deny,

cancel or suspend Ihe registration of my product in conformity with FIFRA.

the statements I have made on this fonn and all attachments to it are true, accurate and complete. I

any knowingly false or misleading statements may be punishable by fine or imprisonment or both under



### 27,2010E''"'''',UNITEDSTATESENVIRONMENTALPROTECTIONAGENCY-'"-401MStreet,S.W.FormApprovedOMSNo.2070-0060",..........-WASHINGTON,D.C.20460PaperworkReduclionActNotice:ThepublicreportingburdenforIhiscollectionofinformationisestimaledtoaverage0.25hoursperresponseforregistrationand0.25hoursperresponseforreregistrationaridspecialreviewactivities,includingUmeforreadingtheInstructionsandcompletingIhenecessaryforms.Sendcommentsregardingburdenestimateoranyotheraspectofthiscollection01informalion.includingslI9gestionsforreducingtheburdento:Director,OPPEInformationManagementDivision(2137),U.S.EnvirornnentalProtectionAgency,401MStreet.S.w.,Washington,DC20460,Donotsendthecompletedformtothisaddress.DATAMATRIXDate:May27,2010EPAReg.No.lFileSymbol:35935·TOIPage 1of7NufarmLimitedPOBox13439Product:MetalaxylTechnicalResearchTrianglePark,NC27709Ingredient:Metalaxyl(PCCode113501)GuidelineReferenceNumberGuidelineStudyNameMRIDNumberSubmitterStatusNoteOPPTSSeries830ProductProperties830.1550Productidentityandcomposition47498601NufarmLimited(035935)Owo830.1600Descriptionofmaterialsusedtoproducetheproduct47498601Nufarmlimited(035935)Owo830,1620Descriptionofproductionprocess47498601Nufarmlimited(035935)Owo830.1650Descriptionofformulationprocess.._.NfA1830.1670Discussionofformationofimpurities47498601Nufarmlimited(035935)Owo830.1700Preliminal)'analysis47498602Nufarmlimited(035935)Owo830.1750CertifiedHmits47498602Nufannlimited(035935)Owo830.1800Enforcementanalyticalmethod47498602Nufarmlimited(035935)Own830,1900Submittalofsamples....NfA2830.6302Color47498603Nufarmlimited(035935)Owo830.6303Physicalstate47498603Nufarmlimited(035935)Owo,--,830.6304Odor-47498603Nufarmlimited(035935)Owo--830.6313Stabilitytonormalandmetals,andmetalions47498603Nufarmlimited(035935)Owo830.6314Oxidation/reduction:chemicalincompatibility-..NfA3830.6315Flammabifity.-..NfA4.Signa/2:::.---NameandTitleDate/NathanP.EhresmanfProductRegistrationManagerMay27,2010EPAForm4570-35(9-ronicandPaperversionsavailable.SubmitonlyPaperversion.AgencyInlernalUseCopy.......UNITEDSTATESENVIRONMENTALPROTECTIONAGENCY'n'401MStreet,S.W.1,lY21FormApprovedOMBNo.2070-0060WASHINGTON,D.C.20460PaperworkReductionActNottce:Thepublicreportingburdenforthisconectionofinformationisestimatedtoaverage0.25hoursperresponseforregistrationand0.25hoursperresponseforreregistrationandspecialreviewactivities,includingtimeforreadingtheinstructionsandcompletingthenecessaryforms.Sendcommentsregardingburdenestimateoranyotheraspectofthiscoflectionofinformation.includingforreducingtheburdento:Director,OPPEtnformationManagementDivision(2137),U.S.EnvironmentalProtectionAgency,401MStreet,S.W.,Washington.DC20460.Donotsendthecompletedformtothisaddress.DATAMATRIXDate:May27.2010EPAReg.No.lFileSymbol:35935-TOIPage 2of?NufarmLimitedPOBox13439Product:MetalaxylTechnicalResearchTrianglePark,NC27709Ingredient:Metalaxyl(PCCode113501)830.6316Explodability....NIA5830.6317StoragestabilityPendingNufarmLimited(035935)OW"830.6319Miscibility....NIAB830.6320CorrosioncharacteristicsPendingNufarmLimited(035935)OW"830.6321Dielectricbreakdownvoltage....NIA7830.7000pH47498603NufarmLimited(035935)OW"830.7050UVNisibleabsorp-tion47498603NufarmLimited(035935)OW"830.7100Viscosity....NIAa830.7200Meltingpoint/meltingrange47498603NufarmLimited(035935)OW"830.7220Boilingpoint/boilingrange....NIA9830.7300Densitylrelativedensityfbulkdensity47498603NufarmLimited(035935)OW"830.7370Dissociationconstantsinwater47498603NufarmLimited(035935)Own830.7520Particlesize,fiberlength,anddiameterdistribution"..NIA10830.7550Partitioncoefficient(n·octano'lw<:lter).:o.hakc;,-flaskmethod....NIA11830.7560Partitioncoefficient{n-octano"dw-dtei\-qeneiatorcolumnmethod""NIA12830.7570Partitioncoefficient(n-octanol!water),estimationbyliquid47498803NufarmLimited(035935)OW"chromotography...;:;andTitleDate.-:nt'A"NathanP.EhresmanIProductRegistrationManagerMay27,2010,,,>""".., "....r"..../""'"UNITEDSTATESENVIRONMENTALPROTECTIONAGENCY,n.'401MStreet,S.W.FormApprovedOMSNo.2070..0060\>:ll!'t!","","WASHINGTON,D.C.20460PaperworkReducttonActNottce:ThepublicreportingburdenforIhiscollectionofinformalloniseslimaledtoaverage0,25hoursperresponseforregistrationand0.25hoursperresPQnseforreregistrationandspecialreviewactivities,includingtimeforreadingtheInstrucllonsandcompletingthenecessaryforms.Sendcommentsregardingburdenestimateoranyotheraspectofthiscollectionofinformation,includingsuggest"lonsforreducingtheburdento:Draetor,OPPEtnformat'lonManagementmvis'lon(2137).U.S,Env'lrormentalProtectionAgency,401MStreet,S.W.,Washington.DC20460.Donotsendthecompletedformtothisaddress,DATAMATRIXDate:May27.2010EPAReg.No.lFiteSymbol:35935·TOIPage3of7NufarmlimitedPOBox13439Product:MetataxylTechnicatResearchTdanglePark.NC27709Ingredient:Metalaxyl(PCCode11350t)830.7840Watersolubitity:columnelutionmethod;shakeflaskmethod47498603Nufarmlimited(035935)Own830.7860Watersolubltity:generatorcolumnmethod""NfA13830.7950Vaporpressure47498603Nufarmlimited(035935)OwnI-------.-.--::1NameandTitieDateNathanP.EhresmanIProductRegistrationManagerMay27,2010'm8570·35t9-97)ElectronicandPaperversionsavailable.SubmltonlyPaperverSion."j\:gencyInternatUseCopy"''''......UNITEDSTATESENVIRONMENTALPROTECTIONAGENCY(oft';401MStreet,S.W.FormApprovedOMSNo.2070·0060WASHINGTON,D,C,20460PapelWorkReductionActNotice;Thepublicreportingburdenforthiscollectionofinformationisestimatedtoaverage0.25hoursperresponseforregistrationand0.25hoursperresponseforreregistrationandspedatreviewactivities,incilldingtimeforreadingtheinstructionsandcompletingthenecessaryforms.SendcommentsregardingburdenestimateoranyotheraspectotthiscollectionofinfOIlTlalion,includingsuggestionsforreducingtheburdento:Director,OPPEtnformationManagementDivision(2137),U.S.EnvironmentalProtectionAgency.401MStreet,S.W.,Washington,DC20460.Donotsendthecompletedformtothisaddress.DATAMATRIXDate:May27,2010EPAReg.No./FileSymbol:35935·TOPage4of7NufarmLimitedPOBox13439Product:MetataxylTechnicalResearchTrianglePark,NC27709tngredi"ent;Metalaxyl(PCCode11350t)GuidelineReferenceNumberGuidelineStudyNameMRIDNumberSubmitterStattJsNoteOPPTSSeries870HeatthEffects870.1100AcuteoraltoxiCity"ratCite-AU"PAY870.1200Acutedermattoxicity·rabbitCite-All-PAY870.1300Acuteinhatationtoxicity-ratCite-All"PAY870.2400Primaryeyeinitation"rabbitCite-AU"PAY870.2500Primarydermatirritation-rabbitCite-All"PAY870.2600Dermalsensitization-GuineapigCite·AII-PAY870.5100Bacteriatreversemutationassay47939701NufarmLimited(035935)OWNISlgnaturV]DateNathanP.EhresmanIProductRegistrationManagerMay27,2010lectronicandPaperversionsavaitable.SubmitonlyPaperversion.AgencyInternatUseCopy...UNITEDSTATESENVIRONMENTALPROTECTIONAGENCY",..I401MStreet,S.W.FOlmApprovedOMSNo.2070-0060WASHINGTON,D.C.20460..,,,,,-PaperworkReductionActNottce:ThepublicreportingburdenlorIhiscollectionofinformationisestimatedtoaverage0.25hoursperresponseforregistrationand0.25hoursperresponseforreregistrationandspecialreviewactivities,includingtmeforreadingtheinstructionsandcompletingthenecessaryforms.Sendcommentsregan:fingburdenestimateOranyotheraspectofthiscollectionof"Information,includingsuggesHonslorreducingtheburdento:Dtrector,OPPEInformationManagementDivision(2137),U.S.EnvironmentalProtect'lonAgency,401MStreet.S.W..WaShington.DC20460.Donotsendthecompletedformtothisaddress.DATAMATRIXDate:May27,2010EPAReg.No.lFlleSymbol:35935-TOPage5of7NufarmLimitedPOBox13439Product:MetalaxylTechnicalResearchTrianglePark,NC27709Ingredient:Metalaxyl(PCCode113501)GuidelineReferenceNumberIGuidelineStudyNameMRIDNumberSubmitterIS1atusNoteMetalaxyl(PCCODE113501)GeneriCDataRequirementsCITE-ALLSYNGENTACROPPROTECTION.INC.!000100PAYCITE-ALLWINFIELDSOLUTIONS,LLC1001381PAYCITE-ALLBAYERCROPSCIENCELP!000264PAYLOVELANDPRODUCTS,INC.1034704PAYCITE·ALLE.I.DUPONTDENEMOURSANDCO.,INC.I000352PAYCITE-ALLNUFARMUMITED1035935PAYCITE-ALLCHEMTURACORPORATION1000400PAYCITE-ALLTRACECHEMICALSLLC1042056PAYCITE-ALLALBAUGHINC!042750PAYCITE-ALLNUFARMAMERICASINC.I055146PAYCITE·ALLSIPCAMAGROUSA,INC.I060063PAY--'----CITE-ALLSPRAYDRIFTTASKFORCE!066607OWN,.-'-'--CIT2-.I1LLWILFARML.l.C./068119PAYCITE·ALLNATION'SAG,LLC1070252PAYLI>=t:::.-SCIENCES,LTD.1071532PAY..---,---.Lc>,-...arneandTi1leOate/YNathanP.EhresmanIProductRegistrationManagerMay27,2010_.------------_.-....-...-An..ncvInternaltJ!IODCnnv,.""'"UNITEDSTATESENVIRONMENTALPROTECTIONAGENCY.Aj401MStreet,S,W.FormApprovedOMBNo.2070·0060IS,'",,,,,,,"WASHINGTON,D.C.20460PaperworkReductionActNotice:Thepublicreportingburdenforthiscollectionofinformationisestimatedtoaverage0.25hoursperresponseforregistrationand0.25hoursperresponseforreregistrationandspecialreviewactivities,inctudingtimeforreadingtheinstructionsandcompletingthenecessaryformsSendcommentsregardingburdenestimateoranyotheraspectofthiscotlectionofinformation,includingsuggestionsfOfreducingtheburdento:Director,OPPEtnformationManagementDivision(2137),U.S.EnvironmentalProtectionAgency,40tMStreetS.W"Washington,DC20460.Donotsendthecompletedformtothisaddress.DATAMATRIXDate:May27,2010EPAReg.NO./FileSymbol:35935·TOIPage6of7NufarmlimitedPOBox13439Product:Meta!axylTechnicalResearchTrianglePark,NC27709Ingredient:Me1alaxyl(PCCode113501)CITE·ALLORETF,L.L.C./071754OWN,.CITE·ALlARTF1071755OWN,.CITE·ALLNATIONSAGn,lLC1072167PAYCITE·ALlFESTF.L.L.C./073989OWN"CITE-ALLGUSTAFSONlLC/007501PAYCITE·ALLAHETF/075234OWN"CITE-ALLBASFCORPORATION/007969PAYCITE-ALLPHOENIXENV!RONMENTALCARE,LLC/081943PAYCITE·ALLGESTF/084653OWN,.8,gn("")./0/....f6'NameandTitleDateNathanP.Ehresman1ProductRegistrationManagerMay27,2010-1"....."..111"...rnnu""'.......(.iz)UNITEDSTATESENVIRONMENTALPROTECTIONAGENCY401MStreet,S.W.WASHINGTON,D.C.20460,FormApprovedOMSNo.2070-0060PaperworkReductionActNotice:Thepublicreportingburdenforthiscollectionofinformationisestimatedtoaverage0.25hoursperresponseforregistrationand0.25hoursperresponseforreregistrationandspecialreviewactivities,includinglimeforreadingtheInstructionsandcompletingthenecessaryforms.Sendcommentsregardingburdenestimateoranyotheraspectofthiscollectionofinformation,includingsuggestionsforreducingtheburdento:Director,OPPEInformationManagementDivisiont2t37},U.S.EnvironmentalProtectionAgency,401MStreet,S.W.,Washington,DC20460.Donotsendthecompletedformtothisaddress.Dale:May27,2010NufarmLimitedPOBox13439ResearchTrianglePark,NC27709Ingredient:Metalaxyl(PCCode113501)NoteNo.GuidelineReferenceNo.1830.t6502830.19003830.63144830.63155830.63166830.6319783O.632t8830.71009830.n2010830.7520DATAMATRIXEPAReg.No./FileSymbol:35935-TOIPage7of7Product:MetalaxylTechnicalEXPLANATORYNOTESNameofTestCommentDescriptionofproductionprocessINotapplicabletotechnicalgradeactiveingredient.SubmittalofsamplesINotapplicableunlessspecificallyrequestedbytheAgency.Oxidation/reduction:chemicalincompatibilityINotapplicabletotechnicalgradeactiveingredient.FlammabilityINotapplicabletotechnicalgradeactiveingredient.ExplodabilityIN01applicabletotechnicalgradeactiveingredient.MiscibmtyINotapplicabletotechnicalgradeactiveingredient.DielectricbreakdownvoltageINotapplicabletotechnicalgradeactiveingredient.ViscosityINotapplicabletotechnicalgradeactiveingredient.BoilingpointlboilingrangeINotapplicablebecauseproductisnotaliquid.Particlesize,fiberlength,anddiameterdistributionINotapplicablebecauseproductisnotfibrous.11OuV.l<J;JVPartitioncoefficient(n-octanollwater),shakeflaskmethodAddressedunder830.7570,,""IOjU.fOOUPartitioncoefficientgeneratorcolumnmethodAddressedunder830.7570Watersolubility:cc!ur.1:1:methodAddressedunder830.7840128:"-----13830.7860,...Nufarmisamemberofthistaskforce........L7--------'--'-"-.---;.-:c----:-::::-:----------------,-:c-:---------NameandTitleDateNathanP.Ehresman/ProductRegistrationManagerMay27,2010EPAj16rny8'570-35\9.97)ElectronicandPaperversionsavailable.SubmijonlyPaperversion.AgencyInternalUseCopy

## Re: Data Matrix deficiency**~** 

## Metalaxyl Technical

nathan.ehresman

to:



## Robert Westin

05/27/201011:15 

# AM

Show Details

I'll get this to you today 

### if possible. If not tomorrow at the latest. Thanks Robert.

Nathan P. Ehresman



## Director, Regulatory Affairs

Nufarm Americas, Inc.



### 501 Cascade Pointe Lane, Suite 103



### Cary, NC 27513

Phone: 919.655.0018

Fax: 919.342.5176



### Mobile: 630.418,6035



## natha n. ehresma n@us.nufarm.com

From: Westin.Robert@epamaiLepa.gov

To: nathan.ehresman@uS.nufarm.com

Dale: **05/2712010** 09:53 AM

Subiect: Data Matrix deficiency

- Me\alaxyl Technical



## re: Your application for pesticide registration dated 12/16/09



## EPA File Symbol 35935-TO

EPA Decision Number 398450

Me. Ehresman: 

# Page 1 of2

The data matrix dated 12/16/2009 

## does not list all of the metalaxyl data submitters that are

listed on the Pesticide Data Submitters List dated March 31, 2010, For a cite-all data matrix,

offer to pay letters must be submitted to all of the currently listed data submitters and their



# names and addresses must appear on the data matrix.

The following data submitters are not listed on your data matrix

E,!' DuPont

- company number 352

BASF Corporation

- company number 7969

Albaugh Inc

- company number 42750

Phoenix Environmental Care

- company number 81943

Please submit a revised data matrix and form 8570-34 (Certification with Respect to Citation of

Data)

Robert Westin

file:l/C:\Documents and Settings\rwestin\Local Settings\ T**emp\notesFCBCEE\~web7818.h...** 

## 5/27/2010

## phone:



# FAX:

email: 

# 703-305-5721

703-305-6920

westin.robert@epamail.epa.gov



# ***************************************************** Page 2 of2



## THIS MESSAGE IS INTENDED ONLY FOR THE USE OF THE INDIVIDUAL OR ENTITY TO

WHICH ITIS ADDRESSED AND MAY CONTAIN INFORMATION THA TIS PRIVILEGED,

CONFIDENTIAL AND EXEMPT FROM DISCLOSURE. If the reader of this message is not the

intended recipient or an employee or agent responsible for delivering the message to this intended

recipient, you are hereby notified that any dissemination, distribution, or copying of this communication

is strictly prohibited. 

# If you have received this communication in error, please delete, destroy, and do

not save the message.

Nufarm Americas Inc. and its affiliated companies.



## Fax: +1 6304552001.

file:IIC:\Documents and Settings\rwestin\Local Settings\**Temp\notesFCBCEE\~web7818.h...** 

## 5/27/2010::;/i.;;;.

... 

# ",8"

, 

# .

.**~** v.

### \"_;~d**~** 

## Data Matrix deficiency

- Metalaxyl Technical

Robert Westin 

## to: nathan.ehresman

Bec: Robert Westin



### .........................



## re: Your application for pesticide registration dated 

# 12/16/09

EPA File Symbol 35935-TO

EPA Decision Number 398450

Mr. Ehresman: **05/27/201009:51** 

### AM



## The data matrix dated 

# 12/16/2009 does not list all of the metalaxyl data submitters that

are listed on the Pesticide Data Submitters List dated March 31. 2010. For a cite-all

data matrix. offer to pay letters must be submitted to all of the currently listed data

submitters and their names and addresses must appear on the data matrix.



## The following data submitters are not listed on your data matrix

E.L DuPont

- company number 352

BASF Corporation

- company number 7969

Albaugh Inc

- company number 42750

Phoenix Environmental Care

- company number 81943

Please submit a revised data matrix and form 8570-34 (Certification with Respect to

Citation of Data)

Robert Westin

phone:

FAX:

email: 

## 703-305-5721

703-305-6920

westin.robert@epamail.epa.gov

# i;~'~ UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON. D.C. 20460**~** 

## '-\ 

# '"

-;. 

# ""**~1-** 

## "",0

'>-4£ PRO'"



## MEMORANDUM

Date: May 20, 2010 OFFICE OF

CHEMICAL SAFETY ANO

POLLUTION PREVENTION



## Subject: Metalaxyl. EPA Reg. No. 35935-TO. Impurities Discussion for New Formulation.

PC Code: 113501

Decision No.: 398450

Petition No.: NA

Risk Assessment Type: NA

TXRNo.:NA

MRID No.: 47939701 DP Barcode: 372875



## Registration No.:**35935~TO** 

## Regulatory Action: New Registration

Case No.: NA

CAS No.: 57837-19-1

40 CFR: 180.408



## From: 

# "

/



## Christine Olinger, Chemist

.. 

# £!'l: all.

Health Effects Division (7509P) , / 

# "j{,,-

# ~

Through: Ray Kent, Branch Chief \**~** 

# Mary Manibusan, Branch**Chief'~"1-J** Health Effects Division

# (7509P~

To: Cynthia Giles Parker, Chief

Fungicide Branch

Registration Division (7505P)



## I. Action Requested

Nufann has proposed registration of a new fonnulation for a technical grade (TGAI) product of

metalaxyl that has a different impurity profile from the currently registered TGAL 

## HED had

previously recommended for submission ofa toxicity test on one of impurities (c. 

## Olinger,

8/19109, 

## DP nos. 362019; 366694). Nufann has submitted the results of Bacterial Reverse

Mutation Test for the impurity, and RD 

## has requested review. Note that the proposed

registration number has changed from 

## 35935-LR (as mentioned in the previous memorandwn) to

35935-TO.



# II. HED Conclusions

Based on a review of the toxicity data for the parent compound, a genetic toxicity study for one

impurity, and a structure activity relationship analysis (SAR) of the parent and the impurities,

Page 1 of2

## HED believes that the new TGAI formulation will not have a substantially different toxicity

profile than the existing TGAI formulation. Considering the levels of the impurities that would

be present, RED has no further concerns. A detailed discussion ofthe toxicity and analysis may

be found in the Confidential Appendix to this memorandum.

Attachments:

Confidential Appendix



## Page 2 of2

# Nufarm

December 16, 2009

Mary Waller (PM 21)

Document Processing Desk (REGFEE)

Office of Pesticide Programs (7504P)



## U.s. Environmental Protection Agency

Room 5-4900, Olle Potomac Yard



## 2777 S. Crystal Drive

Arlington, VA 2??02-4501

Subject: Application for New Product Registration

Metalaxyl Technical

EPA Reg. No. 35935-

Dear Ms. Waller: N f 

### Am · 

### I 

## 479397..cO

u arm cncas, nco

ISO I bn','';Wf DrhT. SUilc 200



### Burr Ridge, 11.60327



### Flu»)IC: 630A55.2000 I':\x: 

### 6}114.;:'>.2001

\\"'I"W. US.!ll l(anll.C< nn



### OVERNIGHT COURIER



### The following documents are enclosed in support the resubmission of the Metalaxyl Technical



## application.

• Application for Pesticide Registration (EPA FOrIu8570-1)

• Certification with Respect to Citation of Data {EPA Form 8570-34}

a Two (2) copies of the Confidential Statement of Formula-Basic {EPA Form 8570-4)

• Data Mah'ix- EPA Document (EPA Form 8570-35)

• Data Matrix-Public Document (EPA Form 86570-35)

• Five (5) copies of the Metalaxyl Technical Label

• Pay.gov receipt for PRIA fee

• Volume 1 

### of 2

o Transmittal Document

• Volume 2 of 2

o Schreib, Gudrun. 2009. Reverse Mutation Assay Using Bacteria (Salmonella

typhimurium and Escherichia coli) with Methyl-N-(chloroacetyl)-N-(2,6-

dimethylphenyl)-DL-alaninate prepared by BSt Bioservice Scientific Laboratories GmbH

for Nufarm Americas Inc., BSL Bioservice Shtdy No. 094354, December 3, 2009, 41 pps.

According to PRIA Table 4: Registration Division-New Products, this submission falls under PRIA

Category R320 (new product; new physical form; requires data review in science divisions) \vith a twelve

month review time and a fee of 511,424.

You will remember that this new product registration request and the studies to support it were

previously submitted (7/30/2008). The PRIA date was set for February 2009. EPA requested an

additional 120 day extension, which pushed the PRlA date to June 2009. EPA then requested another

extension of 90 days making a new PRIA date of September 2009. In an 8/26/2009 EPA email, it was

stated that HED needed an Ames test (OPITS Guideline No. 870.5100) on an impurity and asked that

Nufarm consider withdrawing their application because it no longer feB within the original PRIA

category. Nufarm withdrew the application on 9/2/2009.

# Nufarm

Page 2

Ms. Mary Waller

December 16, 2009

An Ames study (enclosed) was conducted on the impurity and the results of the study were negative.

Since the previously submitted data and supporting documents have already been revie''''ed and the only

outstanding study is the Ames study, which exhibit favorable results, Nufarm is hopeful that EPA 

## will

not take the full 12 months allotted to them for this new PRIA category.

Please contact me at 919/655-0701 should you have any questions regarding this submission.



# C// /)

,lit 

# w-r£ 

# rJLizbeth)Rea



## Regulltory Manager

Nufarm Limited

Email: liz.rea@us.nufarm.com

# Mufarm

TRANSMITTAL DOCUMENT

VOLUME 1 OF 2



## 1. Name and Address of Submitter

Nufarm Limited

PO Box 13439

Research Triangle Park, NC 27709



## 2. Regulatory Action in Support of Which This Package is Submitted

Appllcation for Registration of a technical product

Metalaxyl Technical

EPA Reg. No. 35935-



## 3. Transmittal Date

December 16, 2009



## 4. List of 

## Submitted Studies

Volume No.



## 1



## 2 Citation

Transmittal Document

Schreib, Gudrun. 2009. Reverse Mutation Assay

Using Bacteria (Salmonella typhimurium and

Escherichia coli) with MethYI-N-(chloroacetyl)-N-(2,6-



## dimethylphenyl)-DL-alaninate prepared by 

## BSL

Bioservice Scientific Laboratories GmbH for Nufarm

Americas Inc., BSL Bioservice Study No. 094354,

December 3, 2009, 41 pp.



# /II

Company Official:

# ~~~:-:.---

Company Name: Nufarm Limited



# Company Contact: Lizbeth Rea

Phone: 919-655-0701

Email: liz.rea@us.nufarm.com MRID No.



## 47939701

Page 1 of 1'I,EO S1"-'11€ 

# '"'Q ",**i~,** UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, D.C. 20460

- 0



# , ,**~** 

# . "%, ,,-,0

O}'>4( PR01'1oV



## MEMORANDUM

Date: August 18, 2009 OFFICE OF

PREVENTION. PESTICIDES

AND TOXIC SUBSTANCES



## Subject: EPA Reg. No. 35935-LR. Impurities Discussion for New Formulation.

PC Code: 113501

Decision No.: 398450

Petition No.: NA



## Risk Assessment Type: 

## NA

TXRNo.: NA



## MRIO No.: 47765101



## From: Christine Olinger, Chemist

Health Effects Division (7509P)

Through: Ray Kent, Branch Chief

Mary Manibusan, Branch Chief

Health Effects Division (7509P)

To: Cynthia Giles Parker, Chief

Fungicide Branch

Registration Division (7505P)



## J. Action Requested DP Barcode: 362019,366694

Registration No.: 35935-LR

Regulatory Action: New Registration

Case No.: NA



## CAS No.: 57837-19-1

40 CFR: 180.408



## Nufarm has proposed registration of a new iormulation for a technical grade (TGAI) product of

metalaxyl that has a different impurity profile from the currently registered TGAI. The

Registration Division (RD) has requested HED comment on mpurities and their potential

effects on the toxicity of the TGAI.



## II. HED Conclusions

Based on a review of the toxicity data for the parent compound, and a structure activity

relationship analysis (SAR) of the parent and the impurities, HED believes that the new

fonnulation is substantially different than the existing formulation. HED has no concern over

f the impurities. However one impurity, present in concentrations over 1 %, is similar



## in structure to compounds that are carcinogenic by a non-genotoxic mode of action, and the

Page 1 of2

## parent compound, metalaxyl, is not carcinogenic. To confirm that this impurity is similar to

these compounds, HED recommends that the registrant submit a Bacterial Reverse Mutation Test

(Ames test, Guideline No. 870.5100) for the impurity to further characterize the toxicity. If the

impurity is genotoxic then further testing may be needed. A detailed discussion of the toxicity

and analysis may be found in the Confidential Appendix to this memorandum.

Attachments:

Confidential Appendix



## Page 2 of2

# P()I**~~** 

# \**\....0~ ~V\**  

# 'J CVJ

# ~ 

# 21-Day Screen Completed by



# Contractor



# 21-Day Expires on 1/ (L / 

# (6



# Jacket # 3S-'1J:J- 

# TO



# MRID# L(7 

# c; 

# 3'7 J



# Content Screen: Recommended to

§/Fail

86-5 Review: p§IFailed/NA



# Transfer This Jacket to:

LIN])!} 

# Aa!<./Nb/o"v

# Memorandum

Date: 1'2 / 3D / 

# DC!

To: ell 

# CdJ

, 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: 

# D( fully accepted submission

[J 

# partially accepted submission

[J 

# rejected submission:,\£osr-4>-- 

### """,\ "(".so,

# ·ft~

# >~. 

# , "



# . , 

# \ :#

'I"-} ,,0

### ~(**I'ROI~**



# NUF ARM LIMITED

NUF ARM LIMITED

PO Box 13439

RTP, NC 27709- UNITED STATES ENVIRONMENTAL PROTECTION AGENCY



### WASHINGTON, D.C. 20460



## December 29, 2009

OFF!CEOF



### PREVENTION, PESTICIDES AND

TOXIC SUBSTANCES



## Report of Analysis for Compliance with PR Notice 86-5

Thank you for your submittal of22-DEC-09. Our staff has completed a preliminary

analysis of the material. The results are provided as follows:

Your submittal was found to be in full compliance with the standards for submission of

data contained in PR Notice 86-5. A copy of your bibliography is enclosed, annDtated with

Master Record ID's (MRIDs) assigned to each document submitted. Please lise these numbers in

all future references to these docrnnents. Thank you for your cooperation. If you have any

questions concerning this data submission, please raise them with the cognizant Product

Manager, to whom the data have been released.

# U)

)



### }



## ,I



# , 

# ,

(,



## 7

g

'! 

# - 

# ISB'S Front-end PRlA 

# Completeness Sereen

Drafi 3; 10/25107

\ Receipt Date: 

# DEC 2 2 2009 EPA Reg_ Number: 

# 35'136- 

# To

Check List Item

. 

## Yes No 

# NIA

Has lhc PRIA Fcc been Paid; is a copy of the check or 

# X

I'ily,gnv receipt included in the Submission 

# Package?



# -- ---

Is 

# "'I ApplicatiOil Form (EPA Fom18570-I) Included in the 

# 'I Suhmiss'ill11 Package, is 

# it completely tilled out and signed

llH..:[uding package type?



# -_

.. _ 

### .. 

# -

Is 1l 

## Conridential Statement of Formula (EPA Fonn**8570~** 

# X

21) 

# .Included in the Submission Package, is 

# it completely

filled out and signed (boxes**1~2J)?**



## Is I.l 

## Formulator's Exemption Statement (EPA Form**8570~** 

## 27) Included in the Submission Package?**"-~---** 

# ---

Is ,I 

## CertificatIon with Respect to Citation of Data (EPA 

# !

h)r111**g570<~4)** 

## Included in the Submission Package?**--.~-~-~** 

## Is II 

## nata Mntrix (EPA Form 8570-35) Included in the 

# X Submission Package'?**~"'~-** 

## Is i.l 

## Lnllcl Included in the Submission Package?**-.~---~** 

# 'I

Are Ihta Included in the 

## Submission Package'? 

# ;<

Is the Su bmissioll nil Amendment?

# PRlA 2 - 21 Day Content Screen Review Worksheet

(EPNOPP Use Only)



# 3/23109

21 Day Screen Start Date: 

# /;2 -.2;:;

- () 'j



## Experts In-Processing Signature: 

# 73 '**~** 

## Date..l;2 -..72-07 

## Fee Paid:

# Yes~ Division management contacted on issues No Yes**Date~** 

# _____ _

EPARe g .NW11ber:35)13.5_ 

# la EPA Receipt Date: 

# /,;;? -2:J- D 

# 'l

Items for Review Yes No



## 1 Application Form (EPA Fonn 8570-1 )(link to fom1) signed & 

## complete 

# K including package type

Confidential Statement of Formula all boxes completed, fonn signed, and 

# "'"-

dated (EPA Fonn 8570·4} (Link to fonn) 

# I

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

Footnote A)

3 

## Certification with Respect to Citation of Data (EPA Fonn 8570-34) (Link to 

# ';Z fonn) completed and signed (N/A if 100% repack)

Certificate and data matrix consistent 

# K

If 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.

Formulatoes Exemption Statement (EPA Form 8570-27) (Link 

## to fonn)

4 

## completed and signed (N/A if source is unregistered or applicant owns the

teclmical)

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

# V. 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

b) Cite-All (Fee category experts use)

c) Applicant owns all data (Fee category experts use)

5 Copies ofLabeI (link to htt12:I/www,eQa.gov/oQQfeadlllabelinVlrml) 

# >( 6 

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

http://www .epa.gov/pesticides/regulating/registering/submissions/index.htm#labels

)



## I 

## N/A



# y

# - -

7 Is the data package consistent with PR Notice 86-5 (link to PRN 86-5) 

# X

Notice of Filing (link to

8 htt[!://www.c[!:a.gov/Qesticides/regulatingLtolerance netitions.htm) included

with 

## petitions (link 

## to

http://lvww.epa.gov/pesticides/regulatimvtolerances.htm)**~**



## 9 If 

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

http://WtvVt'.epa.gov!opprdOOlhvorkplanireducedrisk.html) 

# crRequired Data (link to



# httQ:II-www.cQa.gov/l!esticides/regulatin£fdata reguirements.htm) and/or

data waivers. See Footnote C.

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



# 10

2

## Comments:

# ~5-\1..td\e.s 

# r etss.ed 1i 

# r S 

# @ Il-l'l-d1



# _

# -k~vi'C"\ I 

# VlO't"'tvt-s' 

# -\"I>

# t\~p~vt

t.j 

# 1'1**~'\l**

* NJA

- 

## Not Applicable

Footnotes

A. 

## During the 21 day initial content review, all CSFs will be reviewed to detenuine

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 CSF, 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

CSF and may require submission of data. All infonuation, fanus, data and

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

application withdrawn within the 21 day period. othenvise, 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://,, ..vw.epa.gov/opprdOOllinertsllists.html]' and lfthe 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 (IIAB) at inertsbranch@epa.gov and resolve the issue. Copies of the

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

new inerts except PIP inerts are reviewed by IlAB. The IIAB 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

http://www.epa.gov/oppbppdllbiopesticides/contactsbppd.htm].

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

additional inf01mation such as an alternate name ofthe inert, CAS number or other

infonnation [link to http://www.epa.gov/opprdOOllinerts/tips.pdt] must also be included

to enable the Agency to detennine ifit has been approved. Each component of an inett

mixture (including a fragrance) must be identified. In some cases, the supplier of the

mixture or fragrance may need to provide this infonnation 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 infonnation to the individual

identified by the Agency when the applicant is infonned 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 

# esp, the Agency will 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 infonnation 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 accommodate

the inert review/approval process;

4

## 3. Withdi I 

## the application (the Agency retains 2'::' loot the full fee for the fee

category estimated); or

Ifnone of these 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 ofthe category identified.

Conventional New Product Applications

\Vhen the Registration Division identifies an unapproved inert on a CSF with an

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

inert approval (R311, R3l2 ffi' 

## R3l3), it "ill 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 infonnation 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 PRIA

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

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 appropriate fee for the new product-inert approval category.

PIP Applications

When 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:

I. 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 infonnation and data needed for the Agency to approve the

lmapproved 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. \Vithdraw 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 

# 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 (similarlidentical) 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.

6:1£0 S1"-'I,,€**~",\** <$'. 

# i 

# ft**~** UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, D,C, 20460

## <~. • 0



### o < 

# "**~ ,~**  

# "

"J'"-'I{ PRO'It:



## December 28, 2009

opp 

## Decision Number: D-425256

EPA File Symbol or Registration Number: 35935- TO

Product Name: MET ALAXYL TECHNICAL

EPA Receipt Date: 22-Dec-2009

EPA Company Number: 35935

Company Name: NUF ARM LIMITED

WILLIAM M. MAHLBURG

NUF ARM LIMITED

NUFARM LIMITED

PO Box 13439

RTP, NC 27709- OFFICE OF

PREVENTION, PESTICIDES AND

TOXIC SUBSTANCES



## SUBJECT: Receipt of Registration Application Subject to Registration Service Fee

Dear Registrant:

The Office of Pesticide Programs has received your application and certification 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: R320

NEW PRODUCT;NON-FAST TRACK;NEW PHYSICAL FORM (EXCLUDES SELECTIVE

CIT ATlONS);

No additional payment is due at this time.

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

Ombudsman at (703) 305-6249,

Sincerely, 

# C'**~V~**

Front End Processing Staff

Information Technology & Resources Management Division

# IFee for Servicel ),(



# f864528B-

;--**--------~---** 

# ------- 

# :-



# This package includes the following for Division

@ 

# New Registration

°Amendment

ill 

# Studies? Fee Waiver?

,; 

# OAD

oBPPD

@RD

Risk Mgr. 

# []I] ------,



# ! LI 

# volpay 

# % Reduction:

_**~~-~~~--~-~~~~~ -~-~~--~-~-~** **-~~~~~~~~-~~~j, ~====:;**  

# _ ____________ J**r-----~~~-~-~-~~~~~------~--~~~~~-~-~~~~~~~~----~~-~~~~~~;:::**



# I 

# Receipt No. 

# s-I 864528 

# 1

EPA File Symbol/Reg. No. 1 

# 35935-TO I



# Pin-Punch Date: 

# I 12/22/2009 

# I

- 

# --------

- -----,--**--~-----** -------------



# r--, This item is NOT subject to FFS action.**~**

# i~Co-dEr:- 

# ParenVChild Decisions:

Requested: 

# I'R

3;;ZO



# Granted:

1.-'1 

# E=-:3:::..A'---U_---'

1

___ 

# Amount Due:

# $~~:

!Zl 

# Inert Cleared for Intended Use Ic2J 

# Uncleared Inert in Product

.-.-p/" 

# .....-, ' 

# Reviewer: (OHD 

# L"j

I



# Remarks: 

# Date: (;1.- 

# z ,;- 

# c5

## Pay.gov

- Online Payment



# Online Payment

Online Payment



## Step 3: Confirm Payment

Thank you.

Your transaction has been successfully completed.

Pay.gov Tracking Information

Application Name: PRIA Service Fees

Pay.gov Tracking 10: 25040ULJ

Agency Tracking 10: 74093198004

Transaction Date and Time: 12/16/200910:09 

### EST

Payment Summary

Address Information Account Information Payment Information 

# Page 1 of 1

1 

# 1213

Account

# ~~~:~ Lizbeth Rea

150 Harvester

Billing Address: Drive Card Type: Master Card Payment Amount: $11,424.00

Billing

## Addre~~ Suite 200

City: Burr Ridge

State 1 

### Province: IL

Zip 

### 1 Postal Code: 60527

Country: USA Card Number: ************9339 Transaction Date 12/16/2009



### Decision Number: and Time: 10:09 EST

Registration 35935

Number:

Company Name: Nufarm Limited

Company 35935

Number:

Action Code: R320

Do you want to 

# I create 

# I

a new plastic card?



## https:llwww.pay .gov Ipaygov/payments/authorizePlasticCardPayment.html 12116/2009

# r:;:2ase

read instructions on reverse be/ore

# {;~ .-,teting form. Form Apploved. OMS No. 2070-0060



# &EPA Unitod Stoles

# f~] 

# Registration 

# Ll**~~:~dment** opp ldol"ltifier Number



## Environmental Protection Agency

Washington, DC 20460



## Application for Pesticide

- Section I

L Compal"lyff>rodu(:t Numbor 2. EPA Product Mal"lQgor 

# 13. Propou<l Cloulfi(:.ltion

# p9~5- 

# 10 Mary}!!aller 

# ------i

LxJNone 

# t_J

RMtricted

4. Company/Product (Namol PM' i 

## }"letalaxyl Technical 21 

# I

5, Name ond Add/llss at Applicant IIncludo ZIP Codel



### Nufarm Limited

PO Box 13439 6. Expedited Reveiw, In accordance with FIFAA Section 3(c){3)



### (blli), my 

### product is similar or identical in composition and labeling

to: 

## EPA Reg. 

## No.**~1532.3** Research Triangle Park, NC 27709

. 

# __ ._-- 

# C

Chock if this 

# r$" flOW sddftlSS 

### Product Name LG 

## Metalaxyf Technical



# Section

- II 

# U

Amendment· Exploil"l below. 

# I

[J

Resubmhmiol"l in respol"lso to Agency lettor deted

-.,-

.. -----. 

# D

Notitic8tiol"l

- Expleil"l below. 

# u

[]

l!<J

Explanation: Use edditiol"lol pllgels) if**l"Ieco$~s'y.** IFor :IOoctiol"l I sod Section II.)



### New Product Submission: Fil"lot pril"ltod labels in ropsol"lu to

AgeMY letter dotod**~Me** TQo· Application.

Other

- Exploil"l below.



### R320 (New product; new phYSical form; requires data review in sCience diVisions)

$11.424.00 PRIA )I 

### Fee, 12 month review



# Section**~** 

## III**::"~_~t~~iel** fbi.

### P~?~_~~.Wi;~'p.ck.g.d 

# 11"1: -T---------------,-------------

Child·R(!silU(ll"lt PocklllOil"lg I Unit Pockllgil"lg i Water Soluble Pockogil"lg 2. Type 01 COl"ltoil"101



### )Lj No 

## ,0.J No 

### i 

# l2J

No I Glass



## -



# ..**-~** 

# --I

V" I' 

# W

V" 

# i 

# u

V"

# ~..**~::~,**

C6rlifiCfltion must Unit PBckliglog wgt. cOl"ltoioer Package wgt cOl"ltail"le' Other ISpecily).

______ _ • •. If**~YO$~** No. per II**~Ye$·** No. per 

# I

Paper



### be 5ubfffltied 

# I**~' ~~~~----~**  3. Looetiol"l of Net con,ten1ts Information 4. Siu(:!-) Relail COl"lteiMr 

# ?

Locetion of Label Directions



### X Lebel 

# U

# Contain"~,_**,,-''''''''''-.-'''---~.-'----.,.7--'** 

# U,,[==I'-

________________ -I

6. Monner in Which Lebel is Aflixed to Product 

# I' jLithOg:reph 

# U

Oth.u •

______ ••

_______ _ 

## L x Papor glu6d

__ Stencif6d



# Section

- IV**~~ontect** Point**tComp~~!!em$** direcrly below for identification of ffldrvfdu(J1 to be cOflr(JCflld, if**fI!_c::!!!..s..'!~.,~r:.,~'?.~~$** rhbJ tyJplrc:'Crr"c'C·.' 

# -----1

N3/Tie ------rTitlo 

# 1 Telophol"lC No, IInclud'l AI68 Codal

# ~b."th Rea

._ .. _ .... _. __ . I, 

## I

# Regulato~**Manager.91~.·6T5.5** •.

# 0.7.U.~ .. ---

Certification ' 

# !

6. Oet& Application

I cortily that the Glatements I havtl milda 

# 01"1 this form and all atlachmants tharato !Ira truo, !lCcUrete and comrl'lf.

I acknowledge that any kl"lowlinglly falso or milileeding stetement mlly bo puni5hablo by fine or impri$onrlWl"lt or**~undor** opplicetbloluw.

# rtc:~Lt 

# rZ--**Regulato~** Manager 

# I--'

4. Typod N e 5.00to



## Lizbe ea 12/16/2009 3, Title

EPA Form 

### 8570·' IAev. 3-941 Previous editions arlt obsolete. lNhi" • EPA 

### File COJIY loriginall 

### , Rei-:tH"oo

(Stamped)

V.llow • Applicant Copv

# Nufarm

December 16, 2009

Mary Waller (PM 21)

Document Processing Desk (REGFEE)

Office of Pesticide Programs (7504P)



# u.s. Environmental Protection Agency

Room 5-4900, One Potomac Yard

2777 S. Crystal Drive

Arlington, VA 22202-4501

Subject: Application for New Product Registration

Metalaxyl Technical

EPA Reg. No. 35935

M



## Dear Ms. Waller: Nufann Americas, Inc.

150 Harvester Drive, Suite 200

Burr Ridge, IL 60527

Phone: 630.455.2000 Fax: 630.455.2001

www.us.nufarm.com



### OVERNIGHT COURIER



## The following documents are "enclosed in support the resubmission of the Metalaxyl Technical

application.

• Application for Pesticide Registration (EPA Form 8570-1)

• Certification with Respect to 

## Citation of Data (EPA Form 8570-34)

• Two 

## (2) copies of the Confidential Statement of Formula-Basic (EPA Form 8570-4)

• Data Matrix- EPA Document (EPA Form 8570-35)

• Data Matrix-Public Document (EPA Form 86570-35)

• Five (5) copies of the Metalaxyl Technical Label

• Pay.gov receipt for PRIA fee

• Volume 1 of 2

o Transmittal Document

• Volume 2 of 2

o Schreib, Gudrun. 2009. Reverse Mutation Assay Using Bacteria (Salmonella

typhimurium and Escherichia coli) with Methyl-N-(chloroacetyl)-N-(2,6-

dimethylphenyl)-DL-alaninate prepared by BSL Bioservice Scientific Laboratories GmbH

for Nufarm Americas Inc., BSL Bioservice Study No. 094354, December 3, 2009, 41 pps.

According to PRIA Table 4: Registration Division-New Products, this submission falls under PRIA

Category R320 (new product; new physical form; requires data review in science divisions) with a twelve

month review time and a fee of $11,424.

You will remember that this new product registration request and the studies to support it were

previously submitted (7/30/2008). The PRIA date was set for February 2009. EPA requested an

additional 120 day extension,. which pushed the PRIA date to June 2009. EPA then requested another

extension of 90 days making a new PRIA date of September 2009. In an 8/26/2009 EPA email, it 

## was

stated that HED needed an Ames test (OPPTS Guideline No. 870.5100) on an impurity and asked that

Nufarrn consider withdrawing their application because it 

## no longer fell within the original PRIA

category. Nufarm withdrew the application on 9/2/2009.

# Nufarm

Page 2

Ms. Mary Waller

December 16, 2009

An Ames study (enclosed) was conducted on the impurity and the results of the study were negative.



## Since the previously submitted data and supporting documents have already been reviewed and the only

outstanding study is 

## the Ames shtdy, which exhibit favorable results, Nufarm is hopeful that EPA 

## will

not take the full 12 months allotted to them for this new PRIA category.

Please contact me at 919/655-0701 should you have any questions regarding this submission.

# ~lx£e---

Rea



## ory Manager

Nufann Limited

Email: liz.rea@u5.nufarm.com

# Nufarm

TRANSMITTAL DOCUMENT

VOLUME 1 OF 2

1. Name and Address of Submitter



## Nufarm Limited



## PO Box 13439

Research Triangle Park, NC 27709

2. Regulatory Action in Support of Which This Package is Submitted



## Application for Registration of a technical product

Metalaxyl Technical



## EPA Reg. No. 35935-

3. Transmittal Date



## December 16, 2009

4. List of Submitted Studies

Volume No. Citation



## 1

2 Transmittal Document

Schreib, Gudrun. 2009. Reverse Mutation Assay



## Using Bacteria (Salmonella typhimurium and



## Escherichia coli) with Methyl-N-(chloroacetyl)-N-(2,6-

dimethylphenyl)-DL-alaninate prepared by BSL

Bioservice Scientific Laboratories GmbH for Nufarm

Americas Inc., BSL Bioservice Study No. 094354,



## December 3, 2009, 41 pp. 

# i;]L£fL-

Company Official:

# LiZb~ Rea, Regulatory Manager

Company Name: Nufarm Limited



## Company Contact: 

## Lizbeth Rea



## Phone: 919-655-0701

Email: liz.rea@us.nufarm.com 

## MRID No,

Page 1 of 1

# 51

, U""" F 

### A, -d OMS Nos. 2070-0060: 2070-0057; 21 

### 'v."

.. "v·v t07; 2070-0122; 2070-0t64**~ ~** 

### ~ft>" 

### UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

# "_~ \,_i 1200 Pennsylvania Avenue, N.W.

WASHINGTON, D.C. 20460

Paperwork Reduclion Act Notice: The public reporting burden for this coilectlOn ofmformatloo is estimated 10 average I 25 hoors per response for rcglstrnlion

and 0.25 hoors per response for reregistralion and special review activities. inctuding lime for reading the insmlcliolls and completing the necessary fonns. Scnd

comments regarding burden estimate or any other aspeC! of this collection of informal ion, including suggestions for reducing the buldcn (0: DlreC(OI", Collection

Slrategies Dl\'lsion (2822T), U.s. Environmental Proleclion Agency, 1200**Pcnnsylvan~1** Avenue, N W _ Washington, OC 20460. Do no! scnd Ihe completed form

to Ihis address.

Certification with Respect to Citation of Data

Applicant'sIRegistrant's Name, Address, and Telephone Number EPA Registration NumbertFile Symbol

Nufarm Limited PO Box 13439 Research Triangle Park, NC 27709**630-455~2000** 35935-

Active Inaredientts) and/or reoresentative test comoound(s) Date

Metalaxyl 12/16/2009

General Use Pattem(s) (list all those claimed for this product usina40 CFR Part 158) Product Name

Terrestrial food and nonfood crop, greenhouse food and nonfood ClOP, domestic outdoor and indoor Methalaxyl Technical

NOTE: If your product is a 100% repackaging of another purchased EPA-registered product labeled for all the same uses on your label, you do not need to

submit this form. You must submit the Formulator's Exemption Statement (EPA Form 8570-27).



# D I am responding to a Data-Call-In Notice, and have included with this form a list of companies sent offers of compensation (the Data Matrix form should

be used for this purpose).

SECTION t: METHOD OF DATA SUPPORT (Check one method only)



# D I am using the cite-all method of support, and have included with this form 

# 0 I am using the selective method of support (or cite-all option

a list of companies sent offers of compensation (the Data Matrix form under the selective method), and have included with this form a

should be used for this purpose). completed list of data requirements (the Data Matrix form must be

used).

SECTtON II: GENERAL OFFER TO PAY

IRequired if using the cite-all method or when using the cite-all option under the selective method to satisfy one or more data requirements) 

# 0

I hereby offer and agree to pay compensation, to other persons, with regard to the approval of this application, to the extent required by FIFRA.

SECTtON til: CERTtFtCATtON

I certify that this application for registration, this form for reregistration, or this Data-Calt-tn response is supported by all data submitted or cited in the

applicaflOn for registration, the form for reregistraflOn, or the Data-Call-In response. In addition, if the cite-all option or c'rte-all option under the selective method is

indicated in Section I, this applicaUon is supported by all data in the Agency's fites that (1) concern the properties or effects of this product or an identical or

substantially similar product, or one or more of the ingredients in this product; and (2) is a type of data that would be required to be submitted under the data

requirements in effect on the date of approval of this applicaUon if the application sought the initial registration of a product of identical or similar composiUon and

uses.

I certify that for each exclusive use study cited in support of this registration or reregistration, that I am the original data submitter or that I have obtained

the written permission of the original data submitter to cite that study.

I certify that for each study Cited in support of this registration or reregistration that is not an exclusive use study, either: (a) I am the original data

submitter; (b) t have obtained the permission of the original data submitter to use the study in support of this application; (c) all periods of eliflibility hr

compensation have expired for the study: (d) the study is in the public literature; or (e) t have notified in writing the company that submitted th,': 3tJJ} "nd have

offered (I) to pay compensation to the extent required by sections 3(c)(t)(F) and/or 3(c)(2)(S) of FIFRA: and (ii) to commence negotiations to determine the

amount and terms of compensation, if any, to be paid for the use of the study.

I certify that in all instances where an offer of compensation is required, copies of all offers to pay compensation ar,d ev:Je;,ce of their delivery in

accordance with sections 3(c)(1 )(F) andfor 3(c)(2)(S) of FIFRA are available and will be submitted to the Agency upon reque1t. ShoLid I failloorod'ice such

evidence to the Agency upon request, I understand that the Agency may initiate action to deny, cancel or suspend the**registr~ti,')'1!Jr** My prodl.-.:i i.1 cor.formity with

FIFRA.

It= that the statements I have made on this form and all attachments to it are true, accurate, and com9 i l!'tf'. I ackno\i_led!;l& that any

knowingt or misleading statement may be punishabte by fine or imprisonment or both under applicable taw. 

# / )



# -**Sig,:,,~** 

# G.re6- Date Typed or Printed Name and Title

12116/2009 Lizbeth Rea

EPA Form**8570~** 12-2003) Electronic and Paper versions available. Submit only Paper version.



# S**L.vf~t ~O**  

# J

if**~** 

# - - L**~I**.,.,,0",<,.FormApprovedOMSNo.2070-0060"ftUNITEDSTATESENVIRONMENTALPROTECTIONAGENCY..401MStreet,S.W.WASHINGTON,D.C.20460PaperworkReductionActNotice:Thepublicreportingburdenforthiscollectionofinformationisestimatedtoaverage0.25hoursperresponseforregistrationand0.25hoursperresponseforreregistrationandspecialreviewactivities,includingtimeforreadingtheinstructionsandcompletingthenecessaryforms.Sendcommentsregardingburdenestimateoranyotheraspectofthiscollectionofinformation,includingsuggestionsforreducingtheburdento:Director,OPPEInformationManagementDivision(2137),U.S.EnvironmentalProtectionAgency,401MStreet,S.W.,Washington,DC20460.Donotsendthecompletedformtothisaddress.DateDecember16,2009NufarmLimitedPOBox13439ResearchTrianglePark,NC27709Ingredient:MetalaxylGuidelineReferenceNumber1GuidelineStudyNameOPPTSSeries830830.1550830.1600ProductPropertiesProductidentityandcompositionDescriptionofmaterialsusedtoproducetheproduct830.1620IDescriptionofproductionprocess830.1650IDescriptionofformulalionprocess830.1670IDiscussionofformationofimpurities830.6302IColor830.6303Physicalstate830)l&f4'IIOdo,I'F'r;;L;£iu-_=DATAMATRIXEPAReg.No'/FileSymbol35935-ProductMetalaxylTechnical1MRIDNumberISubmitter--_.-47498601NufarmLimited47498601NufarmLimited47498601NufarmLimited47498601NufarmLimitedNufarmLimitedNufarmLimitedNufarmLimited47498603NufarmLimited47498603NufarmLimited47498603NufarmLimitedNameandTitleLizbethRea,RegulatoryManagerEPAFormJl8'f0-35(9-97)ElectronicandPaperversionsavailable.SubmitonlyPaperversion.AgencyInternalUseCopy(0?),...•/IPage1019IStatus\NoteOW"OW"OW"OW"OW"OW"OW"2OW"OW"OW"Date12/16/2009...w..FormApprovedOMBNo.2070-0060..,.,UNITEDSTATESENVIRONMENTALPROTECTIONAGENCY."""",,'/401MStreet,S.W.WASHINGTON,D.C.20460PaperworkReductionActNotice:Thepublicreportingburdenforthiscollectionofinformationisestimatedtoaverage0.25hoursperresponseforregistrationand0.25hoursperresponseforreregistrationandspecialreviewactivijies,includingtimeforreadingtheinstructionsandcompletingthenecessaryforms.SendcommentsregardingburdenestimateoranyotheraspectofthiscollectionOfjnformation,includingsuggestionsforreducingtheburdento:Director,OPPEInformationManagementDivision(2t37),U.S.EnvironmentalProtectionAgency,40f MStreet,S,w.,Washington,DC20460.Donotsendthecompletedformtothisaddress.DATAMATRIXDateDecember16,2009EPAReg.No.lFileSymbol35935-IPage2of9NufarmLimitedProductPOBox13439MetalaxylTechnicalResearchTrianglePark,NC27709Ingredient:MetalaxylGuidelineReferenceNumber1GuidelineStudyName1MRIDNumber1Submitter1StatusINote830.6313Stabilitytonormalandelevatedtemperatures,47498603NufarmLimitedOwnmetals,andmetalions830.6314Oxidation/reduction:chemicalincompatibility3830.6315Flammability4830.6316Explodability5830.6317StoragestabilityPendingNufarmLimitedOwn830.6319Miscibility6830.6320CorrosioncharacteristicsPendingNufarmLimitedOwn830.6321Dielectricbreakdownvoltage7830.7000pH47498603NufarmLimitedOwn830.7050UVNisibleabsorption47498603NufarmLimitedOwn830.7100Viscosity8830.7200Meltingpointimeltlngrange47498603NufarmLimitedOwn830.7220Boilingpointlboilingrange9830.7300Densitylrelativedensitylbulkdensity47498603NufarmLimitedOwn830.7370Dissociationconstantsinwater47498603NufarmLimitedOwn-_...EPAForm8570-35(9-97)ElectronicandPaperversionsavailable.SubmitonlyPaperversion.AgencyInternalUseCopy""',"....FormApprovedOMBNo.2070-0060"A\UNITEDSTATESENVIRONMENTALPROTECTIONAGENCY401MStreet,S.W.WASHINGTON,D.C.20460PaperworkReductionActNotice:ThepublicreportingburdenforthiscOlleclionofinformationisestimatedtoaverage0.25hoursperresponseforregistrationand0.25hoursperresponseforreregistrationandspecialreviewactivities,includingtimeforreadingtheinstructionsandcompletingthenecessaryforms.Sendcommentsregardingburdenestimateoranyotheraspectofthiscollectionofinformation,includingsuggestionsforreducingtheburdento:Director,OPPEInformationManagementDivision(2t37),U.S.EnvironmentalProtectionAgency,401MStreet,S.W.,Washington,DC20460.Donotsendthecompletedformtothisaddress.DATAMATRIXDateDecember16,2009EPAReg.No.lFileSymbol35935-1Page30f9NufarmLimitedProductPOBox13439MetalaxylTechnicalResearchTrianglePark,NC27709Ingredient:MetalaxylGuidelineReferenceNumber1GuidelineStudyNameLMRIDNumber1SubmitterJStatusINote830.7520Particlesize,fiberlength,anddiameter10distribution830.7550Partitioncoefficient(n-octanollWater),shakeflask11method830.7560Partitioncoefficient(n-octanolfwater),generatort2columnmethod830.7570Partitioncoefficient(n-octanollwater),estimation47498603NufarmLimitedOwnbyliquidchromatography830.7840Watersolubility:columnelutionmethod;shake47498603NufarmLimitedOwnflaskmethod830.7860Watersolubility:generatorcolumnmethod13830.7950Vaporpressure47498603NufarmLimitedOwn40CFR158.340Toxicology870.1100Acuteoraltoxicity-ratCite-AllPAY870.t200Acutederrnaltoxicity-rabbitCite-AllPAY870.1300Acuteinhalationtoxicity-ratCite-AllPAY870.2400Primaryeyeirritation-rabbitCite-AllPAY870.2500Primarydermalirritation-rabbitCite-AllPAY--_...EPAForm8570-35(9-97)ElectronicandPaperversionsavailable.SubmitonlyPaperversion.AgencyInternalUseCopy..FormApprovedOMBNo.2070-0060t',£,'lUNITEDSTATESENVIRONMENTALPROTECTIONAGENCY401MStreet,S.W.WASHINGTON,D,C,20460PaperworkReductionActNotice:Thepublicreportingburdenforthiscollectionofinformationisestimatedtoaverage0.25hoursperresponseforregistrationand0.25hoursperresponseforreregistrationandspecialreviewactivities,includingtimeforreadingtheinstructionsandcompletingthenecessaryforms.Sendcommentsregardingburdenestimateoranyotheraspectofthiscollectionofinformation,includingsuggestionsforreducingtheburdento:Director,OPPEInformationManagementDivision(2137),U.S.EnvironmentalProtectionAgency,40t MStreet,S.w.,Washington,DC20460.Donotsendthecompletedformtothisaddress.DATAMATRIXDateDecember16,2009EPAReg.No.lFileSymbol35935-IPage4of9NufarmLimitedProductPOBox13439MetalaxylTechnicalResearchTrianglePark,NC27709Ingredient:MetalaxylGuidelineReferenceNumber!GuidelineStudyNameMRIDNumber!Submitter1StatusINote870.2600Dermalsensitization-GuineapigCite-AllPAY870.5100BacterialreversemutationassaySubmittingr..{1q30fl-ojNufarmLimitedOWNMetalaxylGenericDataRequirementsNufarmLimitedwillmakeoffers-to-paytothefollowingcompaniesonthedatasubmitterslistofMarch31,2008.GenericDataCite-AllSyngentaCropProtection,Inc.AnN:RegulatoryAffairsPOBox18300PAYGreensboro,NC27419BayerCropScienceLP2T.W.AlexanderDrivePAYRTP,NC27709ChemturaCorporationAnN:CropRegistration1999BensonRoad(2-5)PAYMiddlebury,CT06749EPAForm8570-35(9-97)ElectronicandPaperversionsavailable.SubmitonlyPaperversion.AgencyInternalUseCopyr"""",FormApprovedOMBNo.2070-0060I"ft'jUNITEDSTATESENVIRDNMENTALPROTECTIONAGENCY>"""","/401MStreet,S.W.WASHINGTON,D.C.20460PaperworkReductionActNotice:Thepublicreportingburdenforthiscollectionofinformationisestimatedtoaverage0.25hoursperresponseforregistrationand0.25hoursperresponseforreregistrationandspecialreviewactivities,includingtimeforreadingtheinstructionsandcompletingthenecessaryforms.Sendcommentsregardingburdenestimateoranyotheraspectofthiscollectionofinformation,includingsuggestionsforreducingtheburdento:Director,apPEInformationManagementDivision(2137),U.S.EnvironmentalProtectionAgency,401MStreet,SW.,Washington,DC20460.Donotsendthecompletedformtothisaddress.DATAMATRIXDateDecember16,2009EPAReg.No.lFileSymbol35935-IPage50f9NufarmLimitedProductPOBox13439MetalaxylTechnicalResearchTrianglePark,NC27709Ingredient:MetalaxylGuidelineReferenceNumber..1GuidelineStudyNameMRIDNumber1SubmitterJStatusINoteAliceWalkerConsultingAgentFor:WinfieldSolutions,LLC3094CountryClubRoadPAYSenatobia,MS38668GustafsonLLCPOBox660065PAYDallas,TX75266LovelandProducts,Inc.POBox1286PAYGreeley,CO80632TraceChemicalsLLC2320LakecrestDrivePAYPekin,IL61554-6637SipcamAgroUSA,Inc.300ColonialParkway,Suite230PAYRoswell,GA30076,-EPAForm8570-35(9-97)ElectronicandPaperversionsavailable.Submit onlyPaperversion.AgencyInternalUseCoPy•FormApprovedOMSNo.2070-0060• ' A'<UNITEDSTATESENVIRONMENTALPROTECTIONAGENCY\lSI2'401MStreet,S.W.WASHINGTON,D.C.20460PaperworkReductionActNotice:Thepublicreportingburdenforthiscollectionofinformationisestimatedtoaverage0.25hoursperresponseforregistrationand0.25hoursperresponseforreregistrationandspecialreviewactivities,includingtimeforreadingtheinstructionsandcompletingthenecessaryforms.Sendcommentsregardingburdenestimateoranyotheraspectofthiscollectionofinformation,includingsuggestionsforreducingtheburdento:Director,OPPEInformationManagementDivision(2137),U.S.EnvironmentalProtectionAgency,401MStreet,S.w.,Washington,DC20460.Donotsendthecompletedformtothisaddress.DATAMATRIXDateDecember16,2009EPAReg.No.lFileSymbolIPage6of9NufarmLimitedProductPOBox13439MetalaxylTechnicalResearchTrianglePark,NC27709Ingredien1:MetalaxylGuidelineReferenceNumber1Guideline1MRIDNumber1Submitter\StatusINoteSprayDriftTaskForce1900KStreet,NWOWNWashington,DC20006WilfarmLLC5401N.OakTrafficWayPAYGladstone,MO64118-4627Nation'sAg,LLC20AmbrianceDrivePAYBurrRidge,IL60527Biologic,Inc.Agen1for:LGUfeSciences,LTDPAY115ObtuseHillRoadBrookfield,CT06804Ou1doorResidentialExposureTaskForce,LLC1350IStreet,NWOWNWashington,DC20005-----------EPAForm8570-35(9-97)ElectronicandPaperversionsavailable.onlyPaperversion.AgencyInternalUseCopy...'.,"....FormApprovedOMSNo.2070-0060,ft·UNITEDSTATESENVIRONMENTALPROTECTIONAGENCY,.,-,""#401MStreet,S.W.WASHINGTON,D,C,20460PaperworkReductionActNotice:Thepublicreportingburdenforthiscollectionofinformationisestimatedtoaverage0.25hoursperresponseforregistrationand0.25hoursperresponseforreregistrationandspecialreviewactivities.includingtimeforreadingtheinstructionsandcompletingthenecessaryforms.Sendcommentsregardingburdenestimateoranyotheraspectofthiscollectionofinformation,includingsuggestionsforreducingtheburdento:Director,OPPEInformationManagementDivision(2137),U.S.EnvironmentalProtectionAgency,401MStreet,S.W.,Washington,DC20460.Donotsendthecompletedformtothisaddress.DATAMATRIXDateDecember16,2009EPAReg.No.lFileSymbol35935-1Page7of9NufarmLimitedProductPOBox13439MetalaxylTechnicalResearchTrianglePark,NC27709Ingredient:MetalaxylGuidelineReferenceNumber!GuidelineStudyNameMRIDNumberISubmitter1StatusINoteAgriculturalReentryTaskForce1350IStreet,NWOWNWashington,DC20005NationsAgII,LLC4515FallsofNeuseRoadSuite300PAYRaleigh,NC27609FIFRAEndangeredSpeciesTaskForce,LLC.1350IStreet,NWOWNWashington,DC20005AgriculturalHandlersExposureTaskForcePOBox509OWNMacon,MO63552GenericEndangeredSpeciesTaskForce(GESTF)5008Street,NWOWN,.Washington,DC20004EPAForm8570-35(9-97)ElectronicandPaperversionsavailable.Submit onlyPaperversion.AgencyInternalUseCopy""'..FormApprovedOM6No.2070-0060(..wiUNITEDSTATESENVIRONMENTALPROTECTIONAGENCY401MStreet,S.W.WASHINGTON,D.C.20460PaperworkReductionActNotice:Thepublicreportingburdenforthiscollectionofinformationisestimatedtoaverage0.25hoursperresponseforregistrationand0.25hoursperresponseforreregistrationandspecialreviewactivities,includingtimeforreadingtheinstructionsandcompletingthenecessaryforms.Sendcommentsregardingburdenestimateoranyotheraspectofthiscollectionofinformation,includingsuggestionsforreducingtheburdento:Director,OPPEInformationManagementDivision(2137),U.S,EnvironmentalProtectionAgency,401MStreet,SW.,Washington,DC20460.Donotsendthecompletedformtothisaddress.DATAMATRIXDateDecember16,2009EPAReg.No.lFileSymbol35935-IPag.Bof9NufarmLimitedProductPOBox13439MetalaxylTechnicalResearchTrianglePark,NC27709Ingredient:MetalaxylGuidelineReferenceNumber\GuidelineStudyName\MRIDNumber\Submitter\StatusINoteEXPLANATORYNOTESNoteGuidelineNameafTestCommentNo.ReferenceNo.1830.1650DescriptionofproductionprocessNotapplicabletotechnicalgradeactiveingredient.Guideline830.1620isprimary,2830.1900SubmittalofsamplesNotapplicableunlessspecificallyrequestedbytheAgency.3830.6314Oxidation/reduction:chemicalincompatibilityNotapplicabletotechnicalgradeactiveingredient.4830.6315FlammabilityNotapplicabletotechnicalgradeactiveingredient.5830.6316ExplodabilityNotappl'icabletotechnicalgradeactiveingredient.6830.6319MiscibilityNotapplicablet01echnicalgradeactiveingredient.7830,6321DielectricbreakdownvoltageNotapplicabletotechnicalgradeactlveingredient.8830.7100ViscosityN01applicabletotechnicalgradeactiveingredient.9830.7220Boilingpoint/boilingrangeNotapplicablebecauseproductisnotaliquid.10830.7520Particlesize,fiberlength,anddiameterNotapplicablebecauseproductisnotfibrous.distributionEPAForm8570-35(9·97)ElectronicandPaperversionsavailable.SubmitonlyPaperversion.AgencyInternalUseCopyFormApprovedOMBNo.2070-0060..."..(£'iUNITEDSTATESENVIRONMENTALPROTECTIONAGENCY;::?'401MStreet,SoW.WASHINGTON,D.C.20460PaperworkReductionActNotice:Thepublicreportingburdenforthiscollectionofinformationisestimatedtoaverage0.25hoursperresponseforregistrationand0.25hoursperresponseforreregistrationandspecialreviewactivities,includingtimeforreadingtheinstructionsandcompletingthenecessaryforms.Sendcommentsregardingburdenestimateoranyotheraspectofthiscollectionofinformation,includingsuggestionsforreducingtheburdento:Director,OPPEInformationManagementDivision(2137),U.S.EnvironmentalProtectionAgency,401MStreet,S.W.,Washington,DC20460.Donotsendthecompletedformtothisaddress.DATAMATRIXDateDecember16,2009EPAReg.No.lFileSymbol35935-IPage90f9NufarmlimitedProductPOBox13439MetalaxylTechnicalResearchTrianglePark,NC27709Ingredient:MetalaxylGuidelineReferenceNumber\GuidelineStudyNameIMRIONumberISubmitter1Status1NoteEXPLANATORYNOTESNoteGuidelineNameofTestCommentNo.ReferenceNo.11830.7550Partitioncoefficient(n-octanollwater),shakeAddressedunder830.7570flaskmethod12830.7560Partitioncoefficient(n-octanollwater),generatorAddressedunder830.7570columnmethod13830.7860Watersolubility:generatorcolumnmethodAddressedunder830.7840EPAForm8570-35(9-97)ElectronicandPaperversionsavailable.Submit onlyPaperversion.AgencyInternalUseCopy..FormApprovedOMBNo_2070-0060(..wiUNITEDSTATESENVIRONMENTALPROTECTIONAGENCY401MStreet,S.W.WASHINGTON,D.C.20460PaperworkReductionActNotice:Thepublicreportingburdenforthiscolieclionofinformalioniseslimaled10average0.25hoursperresponseforregislralionand0.25hoursperresponseforreregislralionandspecialreviewactivijies,includinglimeforreadingIheinslruclionsandcomplelingIhenecessaryforms.SendcommentsregardingburdeneslimaleoranyolheraspeclofIhiscolleclionofinformalion,includingsuggeslionsforreducingIheburdento:Direclor,OPPEInformalionManagementDivision(2137),u.s.EnvironmenlalProleclionAgency,401MSireel,S.W.,Washinglon,DC20460.DonolsendIhecompleledform10Ihisaddress.DATAMATRIXDateDecember16,2009EPAReg,No.lFileSymbol35935-IPage1of7NufarmLimitedProductPOBox13439MetalaxylTechnicalResearchTrianglePark,NC27709Ingredient:MetalaxylGuidelineReferenceNumber1GuidelineStudyName-TMRIDNumberl-Submitter\Status\NoteNufarmLimitedOW"NufarmLimitedOwnNufarmLimitedOW"1NufarmLimitedOwnNufarmLimitedOwnNufarmLimitedOW"NufarmLimitedOW"I2INufarmLimitedOW"NufarmLimitedOW"NufarmLimitedOW"DateLizbethRea,RegulatoryManager12/16/2009EPAForrnJW1'0-35(9-97)ElectronicandPaperversionsavailable.SubmilonlyPaperversion.AgencyInternalUseCopy/'''/L._FormApprovedOMBNo.2070-0060:f"jUNITEDSTATESENVIRONMENTALPROTECTIONAGENCYlS!!2•"..401MStreet,S.W.WASHINGTON,D.C.20460PaperworkReductionActNotice:Thepublicreportingburdenforthiscollectionofinformationisestimatedtoaverage0.25hoursperresponseforregistrationand0.25hoursperresponseforreregistrationandspecialreviewactivities,includingtimeforreadingtheinstructionsandcompletingthenecessaryforms.Sendcommentsregardingburdenestimateoranyotheraspectofthiscollectionofinformation,includingsuggestionsforreducingtheburdento:Director,OPPEtnformationManagementDivision(2137),U.S.EnvironmentalProtectionAgency,401MStreet,S.W"Washington,DC20460.Donotsendthecompletedformtothisaddress.DATAMATRIXDateDecember16,2009EPAReg.No.lFileSymbol35935-Jpage2of7NufarmLimitedProductPOBox13439MetalaxylTechnicalResearchTrianglePark,NC27709Ingredient:Metalaxyl..GuidelineLr.1__Number______\StatusNufarmLimitedIOwn345NufarmLimitedOwn6NufarmLimitedOwn7NufarmLimitedOwnNufarmLimitedOwnBNufarmLimitedOwn9NufarmLimitedOwnNufarmLimitedOwnEPAForm8570-35(9-97)ElectronicandPaperversionsavailable.SubmitonlyPaperversion.AgencyInternalUseCopy.-"''''>;''FormApprovedOMSNo.2070-0060{....,UNITEDSTATESENVIRONMENTALPROTECTIONAGENCY:::z'.,.,,,,,,,,"/401MStreet,S.W.WASHINGTON,D.C.20460PaperworkReductionActNotice:Thepublicreportingburdenforthiscollectionofinformationisestimatedtoaverage0.25hoursperresponseforregistrationand0.25hoursperresponseforreregistrationandspecialreviewactivities,includingtimeforreadingtheinstructionsandcompletingthenecessaryforms.Sendcommentsregardingburdenestimateoranyotheraspectofthiscollectionofinformation,includingsuggeslionsforreducingtheburdento:Director,OPPEInformationManagementDivision(2137),U.S.EnvironmentalProtectionAgency,401MStreet,SW.,Washington,DC20460.Donotsendthecompletedformtothisaddress.DATAMATRIXDateDecember16,2009EPAReg.No.lFileSymbol35935-1Page3of7NufannlimitedProductPOBox13439MetalaxylTechnicalResearchTrianglePark,NC27709Ingredient:MetalaxylGuidelineReferenceNumber\GuidelineStudyName\MRIDNumber\SubmitterIStatus\Note101112NufarmLimitedOwnNufarmlimitedOwn13NufarmlimitedIOwnIPAYPAYEPAForm8570·35(9-97)ElectronicandPaperversionsavailable.SubmitonlyPaperversion.-r'''''''>-FormApprovedOMSNo.2070-0060I("""UNITEDSTATESENVIRONMENTALPROTECTIONAGENCY401MStreet,S.W.WASHINGTON,D.C.20460PaperworkReductionActNotice:Thepublicreportingburdenforthiscollectionofinformationisestimatedtoaverage0.25hoursperresponseforregistrationand0.25hoursperresponseforreregistrationandspecialreviewincludingUmeforreadingtheinstructionsandcompletingthenecessaryforms.Sendcommentsregardingburdenestimateoranyotheraspectofthiscollectionofinformation,includingsuggestionsforreducingtheburdento:Director,OPPEInformationManagementDivision(2137),U.S.EnvironmentalProtectionAgency,401MStreet,SW.,Washington,DC20460.Donotsendthecompletedformtothisaddress.DATAMATRIXDateDecember16,2009EPAReg.No.lFileSymbol35935-NufarmlimitedProductPOBox13439MetalaxylTechnicalResearchTrianglePark,NC27709Ingredient:MetalaxylGuidelineReferenceNumber\GuidelineStudyName\MRIDNumberEPAForm8570-35(9-97)ElectronicandPaperversionsavailable.SubmitonlyPaperversion.\SubmitterNufarmlimitedSyngentaCropProtection,Inc.AnN:RegulatoryAffairsPOBox18300Greensboro,NC27419BayerCropSciencelP2T.W.AlexanderDriveRTP,NC27709ChemturaCorporationAnN:CropRegistration1999BensonRoad(2-5)Middlebury,CT06749AgencyInternalUseCopy1Page4of?\StatusINotePAYOWNPAYPAYPAYFormApprovedOMBNo.2070-0060UNITEDSTATESENVIRONMENTALPROTECTIONAGENCY401MStreet,S.W.WASHINGTON,D.C.20460PaperworkReductionActNotIce:Thepublicreportingburdenforthiscollectionofinfonnationisestimatedtoaverage0.25hoursperresponseforregistrationand0.25hoursperresponseforreregistrationandspecialreviewactivities,includingtimeforreadingtheinstructionsandcompletingthenecessaryforms.SendcommentsregardingburdenestimateoranyotheraspectofthiscollecHonofinformation,includ'mgsuggestionsforreducingtheburdento:Director,OPPEInformationManagementDivision(2t37),U.S.EnvironmentalProtectionAgency,40t MStreet.S.W.,Washington,DC20460.Donotsendthecompletedformtothisaddress.DATAMATRIXDateDecember16,2009EPAReg.No.lFileSymbol35935·IPage50f7NufarmLimitedProductPOBox13439MetalaxylTechnicalResearchTrianglePark,NC27709Ingredient:MetalaxylGuidelineReferenceNumberIGuidelineStudyNameMRIDNumberISubmitterIStatus\NoteAliceWalkerConsultingAgentFor:WinfieldSolutions,LLC!3094CountryClubRoadPAYSenatobia,MS38668GustafsonLLCPOBox660065IPAYDallas,TX75266LovelandProducts,Inc.POBox1286IPAYGreeley,CO80632TraceChemicalsLLC2320LakecrestDriveIPAYPekin,IL61554-6637SipcamAgroUSA,Inc.300ColonialParkway,Suite230IPAYRoswell,GA30076EPAForm8570-35(g-g7)ElectronicandPaperversionsavailable.SubmitonlyPaperversion.AgencyInternalUseCopy•FormApprovedOMSNo.2070-0060..ftl\.s:!IrZ;UNITEDSTATESENVIRONMENTALPROTECTIONAGENCY',..",<,401MStreet,S.W.WASHINGTON,D.C.20460PaperworkReductionActNotice:ThepublicreportingburdenforthiscollectionofinformationISestimatedtoaverage0.25hoursperresponseforregistrationand0.25hoursperresponseforreregistrationandspecialreviewactivities,includingtimeforreadingtheinstructionsandcompletingthenecessaryforms.Sendcommentsregardingburdenestimateoranyotheraspectofthiscollectionofinformation,includingsuggestionsforreducingtheburdento:Director,QPPEInformationManagementDivision(2137),U.S.EnvironmentalProtectionAgency,401MStreet,S.W,Washington,DC20460.Donotsendthecompletedformtothisaddress.DATAMATRIXDateDecember16,2009EPAReg.No.lFileSymbol35935-1Page6of7NufarmLimitedProductPOBox13439MetalaxylTechnicalResearchTrianglePark,NC27709Ingredient:MetalaxyJGuidelineReferenceNumber\Guidel"lneStudyName\MRIDNumber\Submitter\Status\NoteEPAForm8570-35(9-97)ElectronicandPaperversionsavailable.SubmilonlyPaperversion.SprayDriftTaskForce1900KStreet,NWWashington,DC20006OWN5401N.OakTrafficWayIPAYGladstone,MO64118-4627IL60527Agentfor:LGLifeSciences,LTD115ObtuseHillRoadBrookfield,CT06804OutdoorResidentialExposureTaskForce,LLC1350IStreet,NWWashington,DC20005AgencyInternalUseCopyPAYPAYOWN""...FormApprovedOMSNo.2070-0060(eilUNITEDSTATESENVIRONMENTALPROTECTIONAGENCY'",_,;;.t401MStreet,S.W.WASHINGTON,D.C.20460PaperworkReductionActNotice:Thepublicreportingburdenforthiscollectionofinformationisestimatedtoaverage0.25hoursperresponseforregistrationand0.25hoursperresponseforreregistrationandspecialreviewactivities,includingtimeforreadingtheinstructionsandcompletingthenecessaryforms.Sendcommentsregardingburdenestimateoranyotheraspectofthiscollectionofinformation,includingsuggestionsforreducingtheburdento:Director,OPPEInformationManagementDivision(2137),U,S.EnvironmentalProtectionAgency,40fMStreet,S.w.,Washington,DC20460.Donotsendthecompletedformtothisaddress.DATAMATRIXDateDecember16,2009EPAReg.No.lFileSymbol35935-IPage7of7NufarmUmitedProductPOBox13439MetalaxylTechnicalResearchTrianglePark,NC27709Ingredient:MetalaxylGuidelineReferenceNumber\GuidelineStudyName\MRIDNumber\SubmitterIStatusINoteEPAForm8570·35(9-97)ElectronicandPaperversionsavailable.SubmitonlyPaperversion.AgricuHuralReentryTaskForce1350tStreet,NWIOWNWashington,DC20005NationsAgII,LLC4515FallsofNeuseRoadSuite300Raleigh,NC27609FIFRAEndangeredSpeciesTaskForce,LLC.t350IStreet,NWWashington,DC20005AgriculturalHandlersExposureTaskForcePOBox509Macon,MO63552GenericEndangeredSpeciesTaskForce(GESTF)5008Street,NWWashington,DC20004AgencyInternalUseCopyPAYOWNOWNOWN

# METALAXYL

TECHNICAL

FOR MANUFACTURING PURPOSES ONLY

ACTIVE INGREDIENT:

Metalaxyl: N-(2,6-dimethylphenyl)-N-(methoxyacetyl)-alanine methyl ester

.......................................................................... 97.0%

OTHER INGREDIENTS:

..................................................... _ ................................... 3.0%

EPA REG. NO. 35935-

EPA EST. NO.

MADE IN CHINA

NET CONTENTS 

### TOTAL:

........................ n •••••••••••••••••••• 

### 100.0%



## KEEP OUT OF REACH OF CHILDREN



# WARNING

For Chemical Spill, Leak, Fire, or Exposure, Call CHEMTREC (800) 424-9300

For Medical Emergencies Only, Call (877) 325-1840

LBS.( KG) 

### MANUFACTURED FOj

NUFARM LIMITE

104T.W. ALEXANDER DRIVE, Bldg.

RESEARCH TRIANGLE PARK, NC 2770 

# Nufarm

05935-00000.20091216.EPA.Frmltr NUP-07274

# I



# , PRECAUTIONARY STATEMENTS

HAZARDS TO HUMANS 

### & DOMESTIC ANIMALS

WARNING

Causes 

### eye irrilation, Harmful if swallowed or absorbed through the skin. Do not get in eyes or on clothing. Wash thoroughly after

handling. Remove contaminated clothinQ and wash before reuse

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FIRST AID 

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IF SWALLOWED 

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Call a poTso-n"controTc'entero;:d-';Ctor immediately**fortre8tmeniadvice-:-~-------------'---"--'l**

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

## I- Do not induce vomiting unless told to do so by the poison control center or doctor. 

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_ Do not give anything by mouth to an unconscious person. 

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IF ON SKIN 

## • Take off contaminated clothing. 

# I OR CLOTHING 

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



## • Call a poison control center or doctor for treatment advice.

IFIN EYES 

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

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

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- Call a poison control center or doctor for treatment advice.**~~-"-,~~"~-,,,,,-~,,~~--~~-~~~--,----~---,~---,--** IF INHALED

_ Move person to fresh air.

If person is not breathing, call911 or an ambulance, then give artrficial respiration, preferably mouth-tomouth if possible.

_ Call a poison control center or doctor for further treatment advice,

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### _ ... HOT LINE NUMBER

Have the product container or label with you when calling a poison control center or doctor, or going for treatment. You may also

contact t-877-325-1840 for emergency medical treatment information. 

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ENVIRONMENTAL HAZARDS

Do not discharge effluent containing this product 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 EPA.

DIRECTIONS FOR USE

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

This product is intended for the formulation of fungicide products. This product may be used to formulate products for specific use(s)

not listed on the MP label if the formulator, user group, or grower has complied with the U.S. EPA data submission requirements

regarding the support of such use{s).

FOR MANUFACTURING USE ONLY INTO A FUNGICIDE FOR THE FOLLOWING USES:

1. Terrestrial Food Crops Including Home Gardens and Orchards

Alfalfa, Birdfoot trefoil, Apples, Asparagus, Avocados, Berries: (Blueberries, Cranberries, Raspberries, Strawberries), Cassava,**C~rus:** (Citrus citron, Grapefruit, Kumquats, Lemons, Limes, Oranges, Tangelos, Tangerines and all hybrids of these), Cole Crops:

{Broccoli, Cabbage, Cauliflower, Chinese broccoli, Gai lon, White flowering broccoli, Chinese cabbage (Napa. Bok choy), Cotton,

Cucurbits: (Balsam pear, Chinese waxgourd,**C~ron** melon, Cucumber, Gherkin, Edible gourds, Cantaloupe, Casaba, Crenshaw,

Honeydew melon, Honey balls, Mango melon, Muskmelon, Persian melon, Pumpkin, Summer squash, Winter squash, Watermelon,

and Cucurbits hybrids), Ginseng, Hops, Leafy Vegetables: (Head Lettuce, Spinach), Legume Vegetables (Succulent or Dried):

{Field beans, Lima beans, Mung beans, Navy beans. Pinto beans, Runner beans, Snap beans, Wax beans, Broad beans (Fava

beans), Chickpeas (Garbanzo beans), Lentils, Lupines (Sweet, White sweet, White and Grain), Garden peas, Field peas, Sugar

peas, Southern peas (Black-eyed peas, Crowder peas, Cowpeas, Catjang) and Edible soybeans, Loquat, Onions: (Dry bulb, Green

Onions, Spring onions or Scallions, Japanese bunching onions, Green shallots or Green eschalots, Leeks), Nut trees: (Almond and

Walnuts), Papaya, Peanuts, Peppers and Eggplant, Pineapple, Root and Tuber Vegetables: {Jerusalem artichoke, Beet {Sugar and

Table}, Carrot, Cassava, Chicory, Ginger, Horseradish, Parsnip, Potato, Radish, Rutabaga, Salsify, Sweet potato, Tanier, Turnip,

Yams), Soybeans, Stone Fruits: {Apricots, Cherries (Sweet and Sour), Nectarines, Peaches. Plums (Chickasaw, Damson, Japanese

Prunes), Tobacco and Tomatoes.

2. Seed Treatment Uses

Carrots, Cotton, Peanuts, Soybeans, Sorghum, Spinach, Sunflowers, Garden Beets, Sugar Beets, Forage,L"'!al'mf'S (Alfal:s, C':ner,

Lespedeza, Beans for Forage, Soybeans for Forage, Soybean Hay. Peanuts for Forage, Peanut Hay, Peas ,'or**F~,rail8,** Pea Vine, Hay,

Cowpeas for Forage, Cowpea Hay, Trefoil, Vetch, and Velvet Beans for Forage), Grain Crops (Wheat, 3arley, ·:<'ye, Oats, Millet,

Milo, Field Corn, Sweet Com; Popcorn, Buckwheat. and Triticale), Rice, Seed and Pod Vegetables (Blac!,;:· fOY:"lr Peas, ChiNpetS,

Garbanzos. Cowpeas, Dill, Edible Soybeans, Field Beans, Field Peas, Garden Peas, Green Beans, Kidney BeHns, lima Beans,

Lupines, Navy Beans, Okra, Peas, Pole Beans, Snap Beans, String Beans, Wax Beans, and Lentils), Pe

.. s, Cucum0t..rs, --;-urf

Grasses, and Forage Grasses. '



### 2For Export Uses:

Cucurbit vegetables, Fruiting Vegetables, Leafy Vegetables, Brassica (Cole) Leafy Vegetables, Root and Tuber Vegetables, Onions,

Corn, Millet, Peas, Sorghum, and Sunflowers.

3. Terrestrial Nonfood Uses

Uses on golf courses, lawns and landscape areas around residential, institutional, public, commercial and industrial buildings.

parks, recreational areas and athletic fields, uses on ornamentals grown in container, bench, fiat, plug, bed or in the field, in

greenhouses, shade houses, outdoor nurseries, retail nurseries, interiorscapes, and other landscape areas.

4. Uses for which the 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 US EPA requirements.

STORAGE AND DISPOSAL

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

PESTICIOE STORAGE: Always use original container to store pesticides in a cool, dry secured warehouse or storage building. Do

not store near food and feed. Containers should be opened in well·ventilated areas. Keep container tightly sealed when not in use.

PESTICIDE DISPOSAL: Open dumping is prohibited. Wastes resulting from the use of this product may be disposed of on site or

at an approved waste disposal facility.

CONTAINER DISPOSAL:

For Plastic or Paper Bags: Completely empty bag into application equipment Then dispose of empty bag in a sanitary landfill or

by incineration, or, if allowed by State and local authorrties, by burning. If burned stay out of smoke.

Plastic Containers: Triple rinse (or equivalent). Then offer for recycling or reconditioning, or puncture and dispose of in a sanrtary

landfill or, by other procedures approved by state and local authorities.

Fiber Drums with liners: Completely empty liner by shaking and tapping sides and bottom to loosen clinging particles. Empty

residue into application equipment Then dispose of liner in a sanitary landfill or by incineration if allowed by state and local

authorities. If drum is contaminated and cannot be reused, dispose of it in the manner required for its liner.

WARRANTY DISCLAIMER

The directions for use of this product must be followed carefully.TO THE EXTENT CONSISTENT WITH APPLICABLE LAW, (1)

THE GOODS DELIVEREDTOYOU ARE FURNiSHED**~AS** IS" BY MANUFACTURER OR SELLER AND (2) MANUFACTURER AND

SELLER MAKE NO WARRANTIES, GUARANTEES, OR REPRESENTATIONS OF ANY KINO TO BUYER OR USER, EITHER

EXPRESS OR IMPLIED, OR BY USAGE OF TRADE, STATUTORY OR OTHERWISE, WITH REGARD TO THE PRODUCT SOLD,

INCLUDING, BUT NOT LIMITED TO MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, USE, OR ELIGIBILITY OF

THE PRODUCT FOR ANY PAR11CULARTRAOE USAGE. UNINTENDED CONSEQUENCES, INCLUDING BUT NOT LIMITED TO

INEFFECTIVENESS, MAY RESULT BECAUSE OF SUCH FACTORS AS THE PRESENCE OR ABSENCE OF OTHER MATERIALS

USEO IN COMBINATION WITH THE GOODS, OR THE MANNER OF USE OR APPLICATION, INCLUDING WEATHER. ALL OF

WHICH ARE BEYOND THE CONTROL OF MANUFACTURER OR SELLER AND ASSUMED BY BUYER OR USER. THIS WRITING

CONTAINS ALL OF THE REPRESENTATIONS AND AGREEMENTS BETWEEN BUYER, MANUFACTURER AND SEllER, AND NO

PERSON DR AGENT OF MANUFACTURER OR SELLER HAS ANY AUTHORITY TO MAKE ANY REPRESENTATION OR

WARRANTY OR AGREEMENT RELATING IN ANYWAY TO THESE GOODS.



### LIMITATION OF LIABILITY

TO THE EXTENT CONSISTENT WITH APPLICABLE LAW, IN NO EVENT SHALL MANUFACTURER OR SELLER BE LIABLE FOR

SPECIAL, INCIDENTAL, OR CONSEQUENTIAL DAMAGES, OR FOR OAMAGES IN THEIR NATURE OF PENALTIES RELATING TO

THE GOODS SOLD, INCLUDING USE, APPLICATION, HANDLING, AND DISPOSAL TO THE EXTENT CONSISTENT WITH

APPLICABLE LAW, MANUFACTURER OR SELLER SHALL NOT BE LIABLE TO BUYER OR USER BYWAY OF INDEMNIFICATION

TO BUYER OR TO CUSTOMERS OF BUYER, IF ANY, DR FOR ANY DAMAGES OR SUMS OF MONEY, CLAIMS OR DEMANDS

WHATSOEVER, RESULTING FROM OR BY REASON OF, OR RISING OUT OF THE MISUSE, OR FAILURE TO FOLLOW LABEL

WARNINGS OR INSTRUCTIONS FOR USE, OF THE GOODS SOLD BY MANUFACTURER OR SELLER TO BUYER. ALL SUCH

RISKS SHALL BE ASSUMED BY THE BUYER, USER, OR ITS CUSTOMERS. TO THE EXTENT CONSISTENT WITH APPLICABLE

LAW, BUYER'S OR USER'S EXCLUSIVE REMEDY, AND MANUFACTURER'S OR SELLER'S TOTAL LIABILITY SHALL BE FOR

DAMAGES NOT EXCEEDING THE COST OF THE PRODUCT.

If you do not agree with or do not accept any of directions for use, the warranty disclaimers, or limitations on liability. do n

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use the product, and return it unopened 

### to the Seller, and the purchtlse price will be refunded.

IRV12 1

. .,09)



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