EPA Registration Number 

35935-79
1

",a",- .. ,au '''''~''''''V'''' ,-,,, ..... =" .......... 'v.'" ... u".tJ''''~''!I ''-'u ... ,'-''''' '""' 'v,,,,, '-" ...... ,.v. ""V' v-vv"""," p.v ..... "'''P''''''' .... "-,, ,-"V & 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 Copy 
2

METALAXYL TECHNICAL 

ACTIVE tNGREDlENT: 

Met,1Ia>¥: 

-al;)mne meth)'! ester .. ..97.0% 

OTHER INGREDIENTS: ........................................ . . ........ 3.0",(, 

TOTAL ...... H)(W% 

EPA R"!J. No. 35935-79 EPA EsL No. 81092-CHN.{J01 

KEEP OUT OF REACH OF CHILDREN 

WARNING 

ForCherricai Leak, Fore, or Exposure, Cal CHEMTREC (800) 424-9300 

For Medk:al Emergencies Only, Call (B77) 325-184<) 

FIRST AID 

• Hold eye o""n and rinse stD\,;y and gently ",;Ih ""Ier lor 15 to 20 

minutes. 

IF IN EyES • Remove contact len""s. present. afler the fi!Sl 5 mimlles. then collinue rinsing eye. 

• Gall a poison control center or doctor l"'lreatment atMce. • Gall a poison control cenlet or doctor immedi51e!y for treatment 

ad';ce. 

IF SWALLOWED 

• Ha..-e person SIp a glass of"",l ... if atle 10 SI"I'ilIlow. 

• DO NOT induce vornilirl!l unless lold to do So by a poi"",n contwl 

center or doctor. 

• DO NOT ive to an unconscious person, 

IF ON SKIN OR 

• Take off contaminated dOlhing. • Ri"'; imrnedalely ",;Ih plenty of waler lor 15 to 2{) mir"OJles. CLOTHlNG • Call a 001 conlrol cenlet or doctm for lreatmenl advice. • Jl"fSQ(I to fresh air. 

IF INHALEO 

• If person is nOI breathing, call 9 ff m an ambulance. then give 

ilI10fidai respirallQ(l, preferably by moulh-to-mouth, "pOSSlUe, 

• Cam a poiSOll control center or doctor lor turther t",atment adllice, 

HOT LINE NUMBER 

Have Ihe producl container or label "'th you vd1en ceiling a poiSOll control """Ier or 

doctor, or going for You may conlact 1-877-325-1840 lor emergen", 

""",",,.al trooImenIlnlotn!l>!ion. -

PRECAUTIONARY STATEMENTS 

HAZARDS TO HUMANS AND DOMESTIC ANIMALS 

WARNING 

C""""S blll temporary eve imta!ion. Harmful s"rdl/ov.ed or absorbed U1rough 

lhe sl<in. Weal goggles or face shield. 00 NOT get 'II' eyes or on ctolh''''g. Wash thoroogrq 

after handflng, Remove contaminated cIolhing and wasil belOIe reuse. 

ENVIRONMENTAL HAZARDS 

DO NOT discharge effluenl containing Ihis prodllC! into Ial<es, streams, poods, estuaoos, 

oceans. or public walers unless in aocortlt>nce wth the requirements ot a National PolkJtant 

o;""""'1Ie System (NPOES) permil arid the perml!IJng aL :h<ml; :1,," been ;.olif,,,,-, 

In 'Mlting prim 10 disdlarge. 00 NOT disdlarge effluent conlainir.r Ihls orodurt 'o"""",r 

sy;lems .,.,;tr.rnrt prellioustv notifying the local sewage treatment pia"' au!h<'1ty. "'or g./:lancc 

contacl your Slate W&.ar Board Or Regional Off"", Of the EPA. 

DIRECTIONS FOR USE 

It is a of Federallawto use th1s prodllC! in a manner ",,,,:misfentv.ith its labeling. 

This prur;lo;cl is inlended for the tormulation ot lunglCJde This prod"": may bv used 

to IormtJlale products lor spoof" use{s) not listed 00 th'" MP :<>bel ItI<;' tor",ula,or. user 

grotf', or g""",r hils compOed y,;th lhe U.S. EPA d';", ",'lbmisNOI1 fe<1uill'meets 

lhe suppert ot such lIse{.). 

FOR MANUFACTURING USE ONLY 

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

f. Terrestrial Food Crops Including Home Gardens alief Orchards: Alfalfa, Birdfool 

trefOIl. Apples, Asparagus, AlIOCat!oS, Be!ries: CranbelTies, Raspbernes, 

Sirawb",,;es), CaSS""<l, Cilrus' (Citrus ti!rOn, Grapefrull, Kumquats. Lemons, urnes. 

Oranges, Tangelos. Tangerines arid aI hybrids of these). Cde Crops: Cetlbage. 

Caulitlo"",r, Chinese brocroli, Gai lon, VI.t1ite tkl'o'aing broccolo, CIlmese cattlage (Napa, 

80k chJy), Coffon. Cocurbits: (Ba;",m pear, Chines.. v.oaxgolmJ, meloo. Cuwmber. 

Gherkin, Edible gourds, Cantalo<4le, Casaba, Crenshaw. Horleydew melon, Honey balls, 

Mango melon, Muskmelon, Pen;iao mobn. Pumpkin. Summar squash, \/',Inler SQUash, 

Watermelon, and CuCUrtlits hybnds), Ginserog, Hops, Leafy (Head Lelluoo, 

Spinach). Legume Vegelables (Succulent or Oned): (Field bealls, Lima beans, Mung beans, 

Navy beans, Pinto beans, Runner beans, Snap beans, Wax boons, Bro,," bean. (Fava 

beans), Chickpea. (Gaibanzo beans), Lentils, Lupines (s.....oel, While '''''''It, VI.t1ite arid 

Grain), Garden ""as. Field peas, Sugar peas, Southern peas (BIock-eyed peas. Crov.tier 

pea., eo,,>,eas, Catjang) and Edible soybeans, Onions' (Doy bulb. Green Otlioos. Spring 

""ions or ScalliOns, J"Ilanese bunching onions, Green shailols or Green e"""a1ots. Leeks). 

Nuttrees' (Almond andVValnuls), Peanllls. Peppers and Eggplant. PireapPla, Root 

am Tuber Vegetables: (Jerusalem artJchoke. Bect (Sugar and Table), Carrot, Cassava, 

Chioooy, Ginger, Horseradim, Parsnip. Potato, RadiSh, R,rtabaga, Salsify, S"""I polalo. 

Tanier. Tum{>, Yams), Soybeans, Stone Fruits: (I\p!icots, Chernes (s,.,eet em 

Nectarines. Pooches, Plums (Ch":k"""'N, Damson, J[ljJaoose Prune,), Tobacco arid 

Tomatoes. 2. Seed Treat"",nl Uses: Cam:>ts, Cotton. PeanulS, Soybeans. Sorghum, Sp;-,acI1, 

Sunn""",rs, Garden Beets, Sugar Beets, Forage Leg .. nes (Malia, Clover. Lespedeu., 

Beans 101 Fomge, tor Fomgc, So)'bean Hay, Peanul. for Fornge, Peanuf Hay, 

Peas 101 F,""gc, Pea Vine Hay, Co""",,, for Fomge, Cowpea Hay. Trefoil Veld" and 

Vel>'el Beans for Forage), Grain CrOps (Wleat, Barley. Rye, Oals, Mile!. Milo, Field Com, 

S""el Corn; Popcorn. Buck'Mleat. and Trilicale), Rice, Seed and Pod VegetaJles (Blfl(;k. 

E:,-ed Peas, Chickpeas, Garbat12os. COWpeas, Oill, Ed,ble Soybeans. Field Beans. Field 

Peas, Garden Peas, Green Beans, KId.-.ey Boons, Lima Bea"s, Lupines, Na-.y Beans, Okra. Peas, Pole Beans, Snap Beans, Slnng Beans, Wax Beans, and LenWs), Peas, Cucumbers. 

T unGrasses. and Forage Grasses. 

J. For Export Uses: Cuwobit Vegetables, Frulling Vegetables, Leafy Vegetables. Brassica 

(Cole) Leafy Veget.:lble., Root and Tuber veget:>bles, Onions, COOl, Mllet. Pea •• SOfIJhum, 

and SLJ/lIIowenl. 

4. T """stria I Nonfood Uses: Turf uses on courses, lawns and tarldscape areas aroum 

re.!denlial, publk:, commer"a1 and industntll buildings, perks, recreational areas 

arid fields, use$ on ornamentals grov.<1 in conlainer. bench. 1IaI, plug,!>ed or in Ihe 

field, m greenhouses, shade houses, oul"""r r"OJrseries, retail nurseries, InteOorscapes, arid 

other landsca"" area$. 5. Uses for wh.,h the US EPA has accepted the reqUired data and'or citations of data 

that the fonnu!a1Or h.,. submitted in support 01 and 

6. Uses for experimental purposes thafare In complia",:ewith US EPA requirements 

STORAGE ANO DISPOSAL 

DO NOT contaminate v.ster. food or teed by stOffigc or dispMal, PESTICIDE STORAGE: Nways use oIiginai container to slore pestlCJdes in a rooI, doy 

secured ",arehoose or storage bulding, 00 NOT slore near tood and feed. Containers shoold be opened ,n areas. Keep cootaineI sealed;oJ,<m nol in use. 

; PESTICIDE DlS?OSAL: Open dumping is prDl1ibited. wastes resulting from !he use of 

, this product may be disposed of on site or at an approved Wilsie dispMalfm:JEty. I CONTAlNERDISPOSAL: 

Plastic or Paper Bogs: Noomfilabla container. DO NOT rruse or refil U1IS CO<ItaO-ler. 

Completely empty bag into manulactunng equipment. Offer lor moydlng available Or 

dispose of empty bag in a sanitaoy landfill or PI' it1dnerallon. or, if alov.ed py slale,.-,d 1<!CaI 

a",>-,omias, by buming. It burned, slay oot of sm<i:e, 

NOT REVIEWED 

In Accordance with PR Notice 82-2 

Based on Draft Labeling Dated 

7/0D 

Plosli<: Containers: co

nnSe (or equ;"alenl) promptly afler em

equipmenl or a mt:< tank and drain 

container fl4 full "';Ih v.ater and re<:«

equipment or a mt:< tanl\ or 810'" rirafler the !low t>egins to dnp. Repeat t

or feCOIlditioning. ,.. puncture Md d

approved by Siale aruj kJcaI aulh

indooraUon. or, if by State a

smoke. 

Fiber drums liners: Nonrefila

Complelely empty "ncr by shal<ing a

paotides. Empty residue inlo manurarocyding, f a\o'ai"ble. 

WARR

TIw directions for use 01 li,ls prud

CONSISTENT WITH APPLICABLE 

FURNISHEO "AS IS" BY MANUFA

ANO SELLER MAKE NO WARRANTANY KIND TO BIJ'fER OR USER, E

TRAOE, STATUTORY OR OTHERW

INUUOING, BUT NOT LlMiTEO 

PARTICUlAR PURPOSE, USE, O

PARTICUIARTRADE USAGE. UN

NOT LlMITEO TO INEFFECTIVENES

!>S THE PRESENCE OR ABSENCE 

WITH THE GOODS. OR THE 

WEATHER, ALL OF WHICH ARE BE

SELLER ANO ASSUMEO BY BUYE

THE REPRESENTATIONS AND AGR

AND SELLER, ANO NO PERSON OAfN AUTHORITY TO MAKE AAGREEMENT RELATING IN A'IN WA

LIMIT

TO THE EXTENT CONSISTENT W

MANUFACTURER OR SELLER 

CONSEQUENTIAL DAMAGES. OR F

RELATING TO THE GOODS SOLO, 

OISPOSAL. TO THE EXTENT 

MANUFACTURER OR SELLER SHA

OF INDEMNIFICATION TO BUYER O

ANY OAMAGES OR SUMS OF 

RESULTING FROM OR BY REASFAILURE TO FOLLOW lABEL WA

GOOOS SOLO BY MANUFACTURCONSISTENT WlTl-! APPLICABLE 

THE BIJ'fER, USER, OR ITS CUS

APPLICABLE LAW. BUYER'S 

MANUFACTURERS OR SELLER'S 

EXCEEOING THE COST OF THE PR

If you do nol agree wilh or do no

disclaimers, or limitations on liabili

10 Ihe Seller, and Ihe purchase priC!

Product 01 China 

NET WEIGHT: 55.11 Lbs. (25.0 K

M;onllfactun>d for NUFARM LIMITED 

104 T.W. Alox:ondllr Drive, Bldg. 5 

TriangloPar1<, No: 27709 
3

Expand M2 

~ 

t 'iJ.-... 

f-.'l1J~ 

~ 

Set up instructions 

I 

'fi ' I 

. 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"""_. 

® 
4

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 
5

~~,"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 
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 
7

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 
8

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 
9

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 
10

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 
11

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 
12

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 
13

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 
14

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 
15

~_:,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 
16

.;;.:.>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 
17

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 
18

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' ' 
19

, 

..,. 

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 

27,2010 
20

E''"'''', UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

- '" - 401 M Street, S.W. Fo

", .......... - WASHINGTON, D.C. 20460 

Paperwork Reduclion Act Notice: The public reporting burden for Ihis collection of information is estimaled to average 0.25 hours per response for registration and 

reregistration arid special review activities, including Ume for reading the Instructions and completing Ihe necessary forms. Send comments regarding burden estimate 

collection 01 informalion. including slI9gestions for reducing the burden to: Director, OPPE Information Management Division (2137), U.S. Envirornnental Protection Ag

Washington, DC 20460, Do not send the completed form to this address. 

DATA MATRIX 

Date: May 27, 2010 EPA Reg. No.lFile Symbol: 35935·TO 

Nufarm Limited PO Box 13439 Product: Metalaxyl Technical 

Research Triangle Park, NC 27709 

Ingredient: Metalaxyl (PC Code 113501) 

Guideline Reference Number Guideline Study Name MRID Number Submitter 

OPPTS Series 830 Product Properties 

830.1550 Product identity and composition 47498601 Nufarm Limited (035

830.1600 Description of materials used to produce the product 47498601 Nufarm limited (035

830,1620 Description of production process 47498601 Nufarm limited (035830.1650 Description of formulation process .. _. 

830.1670 Discussion of formation of impurities 47498601 Nufarm limited (035

830.1700 Preliminal)' analysis 47498602 Nufarm limited (035

830.1750 Certified Hmits 47498602 Nufann limited (035

830.1800 Enforcement analytical method 47498602 Nufarm limited (035830,1900 Submittal of samples .. .. 830.6302 Color 47498603 Nufarm limited (035830.6303 Physical state 47498603 Nufarm limited (035

,--, 

830.6304 Odor - 47498603 Nufarm limited (035

--

830.6313 Stability to normal and metals, and metal ions 47498603 Nufarm limited (035

830.6314 Oxidation/reduction: chemical incompatibility - .. 

830.6315 Flammabifity .- .. 

. 

Signa/2 :::.--- Name and Title 

/ Nathan P. Ehresman f Product Registration Manager 

EPA Form4570-35 (9- ronic and Paper versions available. Submit only Paper version. Agency Inlernal Use Co
21

....... UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 'n' 401 M Street, S.W. 1,lY21 Fo

WASHINGTON, D.C. 20460 

Paperwork Reduction Act Nottce: The public reporting burden for this conection of information is estimated to average 0.25 hours per response for registration and 

reregistration and special review activities, including time for reading the instructions and completing the necessary forms. Send comments regarding burden estimate 

coflection of information. including for reducing the burden to: Director, OPPE tnformation Management Division (2137), U.S. Environmental Protection Ag

Washington. DC 20460. Do not send the completed form to this address. 

DATA MATRIX 

Date: May 27. 2010 EPA Reg. No.lFile Symbol: 35935-TO 

Nufarm Limited 

PO Box 13439 Product: Metalaxyl Technical 

Research Triangle Park, NC 27709 

Ingredient: Metalaxyl (PC Code 113501) 

830.6316 Explodability .. .. 

830.6317 Storage stability Pending Nufarm Limited (035

830.6319 Miscibility .. .. 

830.6320 Corrosion characteristics Pending Nufarm Limited (035830.6321 Dielectric breakdown voltage .. .. 830.7000 pH 47498603 Nufarm Limited (035

830.7050 UVNisible absorp-tion 47498603 Nufarm Limited (035

830.7100 Viscosity .. .. 830.7200 Melting point/melting range 47498603 Nufarm Limited (035830.7220 Boiling point/boiling range .. .. 830.7300 Densitylrelative densityfbulk density 47498603 Nufarm Limited (035830.7370 Dissociation constants in water 47498603 Nufarm Limited (035

830.7520 Particle size, fiber length, and diameter distribution " .. 

830.7550 Partition coefficient (n·octano'lw<:lter). :o.hakc;,- flask method .. .. 

830.7560 Partition coefficient {n-octano"dw-dtei\ -qeneiator column method " " 830.7570 Partition coefficient (n-octanol!water), estimation by liquid 47498803 Nufarm Limited (035

chromotography . 

. 

. 

;:; and Title 

.-:nt'A" Nathan P. Ehresman I Product Registration Manager 

,,,>""" .. , " .... r" 
22

/""'" UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

, n. ' 401 M Street, S.W. Fo

\>:ll!'t! ", ""," WASHINGTON, D.C. 20460 

Paperwork Reductton Act Nottce: The public reporting burden for Ihis collection of informallon is eslimaled to average 0,25 hours per response for registration and 

reregistration and special review activities, including time for reading the Instrucllons and completing the necessary forms. Send comments regarding burden estimate 

collection of information, including suggest"lons for reducing the burden to: Draetor, OPPE tnformat'lon Management mvis'lon (2137). U.S, Env'lrormental Protection Ag

Washington. DC 20460. Do not send the completed form to this address, 

DATA MATRIX 

Date: May 27.2010 EPA Reg. No.lFite Symbol: 35935·TO Nufarm limited PO Box 13439 Product: Metataxyl T echnicat 

Research T dangle Park. NC 27709 

Ingredient: Metalaxyl (PC Code 11350 t) 

830.7840 Water solubitity: column elution method; shake flask method 47498603 Nufarm limited (035

830.7860 Water solubltity: generator column method " " 830.7950 Vapor pressure 47498603 Nufarm limited (035

I -------.-.--::1 Name and Titie 

Nathan P. Ehresman I Product Registration Manager 

'm 8570·35 t9-97) Electronic and Paper versions available. Submlt only Paper verSion. "j\:gency Internat Use Co
23

"'''' ...... UNITED STATES ENVIRONMENTAL PROTECTION AGENCY (oft '; 401 M Street, S.W. Fo

WASHINGTON, D,C, 20460 

PapelWork Reduction Act Notice; The public reporting burden for this collection of information is estimated to average 0.25 hours per response for registration and 

reregistration and spedat review activities, incilldingtime for reading the instructions and completing the necessary forms. Send comments regarding burden estimate 

collection of infOIlTlalion, including suggestions for reducing the burden to: Director, OPPE tnformation Management Division (2137), U.S. Environmental Protection Ag

Washington, DC 20460. Do not send the completed form to this address. 

DATA MATRIX 

Date: May 27, 2010 EPA Reg. No./File Symbol: 35935·TO 

Nufarm Limited 

PO Box 13439 Product: Metataxyl Technical 

Research Triangle Park, NC 27709 

tngredi"ent; Metalaxyl (PC Code 11350 t) 

Guideline Reference Number Guideline Study Name MRID Number Submitter 

OPPTS Series 870 Heatth Effects 

870.1100 Acute oral toxiCity" rat Cite-AU " 870.1200 Acute dermat toxicity· rabbit Cite-All - 870.1300 Acute inhatation toxicity - rat Cite-All " 870.2400 Primary eye initation " rabbit Cite-AU " 870.2500 Primary dermat irritation -rabbit Cite-All " 870.2600 Dermal sensitization - Guinea pig Cite·AII - 870.5100 Bacteriat reverse mutation assay 47939701 Nufarm Limited (035935) 

I SlgnaturV] 

Nathan P. Ehresman I Product Registration Manager 

lectronic and Paper versions avaitable. Submit only Paper version. Agency Internat Use Co
24

... UNITED STATES ENVIRONMENTAL PROTECTION AGENCY ", .. I 401 M Street, S.W. FO

WASHINGTON, D.C. 20460 .. ,,,,,-

Paperwork Reduction Act Nottce: The public reporting burden lor Ihis collection of information is estimated to average 0.25 hours per response for registration and 

reregistration and special review activities, including tme for reading the instructions and completing the necessary forms. Send comments regan:fing burden estimate 

collection of "Information, including suggesHons lor reducing the burden to: Dtrector, OPPE Information Management Division (2137), U.S. Environmental Protect'lon A

WaShington. DC 20460. Do not send the completed form to this address. 

DATA MATRIX 

Date: May 27, 2010 EPA Reg. No.lFlle Symbol: 35935-TO Nufarm Limited 

PO Box 13439 Product: Metalaxyl Technical 

Research Triangle Park, NC 27709 

Ingredient: Metalaxyl (PC Code 113501) 

Guideline Reference Number I Guideline Study Name MRID Number Submitter 

Metalaxyl (PC CODE 113501) GeneriC Data Requirements 

CITE-ALL SYNGENTA CROP PROTECTION. INC.! 000100 CITE-ALL WINFIELD SOLUTIONS, LLC 1001381 CITE-ALL BAYER CROPSCIENCE LP! 000264 

LOVELAND PRODUCTS, INC. 1034704 

CITE·ALL E. I. DU PONT DE NEMOURS AND CO., INC.I 000352 

CITE-ALL NUFARM UMITED 1 035935 

CITE-ALL CHEMTURA CORPORATION 1000400 CITE-ALL TRACE CHEMICALS LLC 1 042056 CITE-ALL ALBAUGH INC! 042750 CITE-ALL NUFARM AMERICAS INC. I 055146 

CITE·ALL SIPCAM AGRO USA, INC. I 060063 

--'----

CITE-ALL SPRAY DRIFT TASK FORCE! 066607 

-'-'--

CIT2-.I1LL WILFARML.l.C./068119 

CITE·ALL NATION'S AG, LLC 1 070252 

LI>=t:::.-SCIENCES, LTD. 1 071532 

.. ---,-

--. Lc> , -. .. arne and Ti1le 

/ Y Nathan P. Ehresman I Product Registration Manager 

_. 

-

---- -- -- ---

_. - .... - . . .- An .. ncv Internal tJ!IOD Cn
25

,.""'" UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

. Aj 401 M Street, S,W. Fo

IS, '",,,,,,," WASHINGTON, D.C. 20460 

Paperwork Reduction Act Notice: The public reporting burden for this collection of information is estimated to average 0.25 hours per response for registration and 

reregistration and special review activities, inctuding time for reading the instructions and completing the necessary forms Send comments regarding burden estimate 

cotlection of information, including suggestions fOf reducing the burden to: Director, OPPE tnformation Management Division (2137), U.S. Environmental Protection Ag

Washington, DC 20460. Do not send the completed form to this address. 

DATA MATRIX 

Date: May 27,2010 EPA Reg. NO./File Symbol: 35935·TO 

Nufarm limited 

PO Box 13439 Product: Meta!axyl Technical Research Triangle Park, NC 27709 

Ingredient: Me1alaxyl (PC Code 113501) 

CITE·ALL ORETF, L.L.C./ 071754 

CITE·ALl ARTF 1071755 

CITE·ALL NATIONS AG n, lLC 1 072167 

CITE·ALl FESTF. L.L.C./ 073989 

CITE-ALL GUSTAFSON lLC / 007501 CITE·ALL AHETF / 075234 CITE-ALL BASF CORPORATION / 007969 CITE-ALL PHOENIX ENV!RONMENTAL CARE, LLC / 081943 CITE·ALL GESTF /084653 

8,gn("" ). /0/ .... f6' Name and Title 

Nathan P. Ehresman 1 Product Registration Manager 

- 1" ..... " .. 111" ... rnn
26

""' ....... 

(.iz) 

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

401 M Street, S.W. 

WASHINGTON, D.C. 20460 

Fo

Paperwork Reduction Act Notice: The public reporting burden for this collection of information is estimated to average 0.25 hours per response for registration and 

reregistration and special review activities, including lime for reading the Instructions and completing the necessary forms. Send comments regarding burden estimate 

collection of information, including suggestions for reducing the burden to: Director, OPPE Information Management Division t2t37}, U.S. Environmental Protection A

Washington, DC 20460. Do not send the completed form to this address. 

Dale: May 27, 2010 

Nufarm Limited 

PO Box 13439 

Research Triangle Park, NC 27709 

Ingredient: Metalaxyl (PC Code 113501) 

Note No. Guideline Reference No. 

1 830. t650 

2 830.1900 

3 830.6314 

4 830.6315 

5 830.6316 

6 830.6319 

7 83O.632t 

8 830.7100 

9 830.n20 

10 830.7520 

DATA MATRIX 

EPA Reg. No./File Symbol: 35935-TO Product: Metalaxyl Technical 

EXPLANATORY NOTES 

Name of Test Com

Description of production process I Not applicable to technical gra

Submittal of samples I Not applicable unless specifica

Oxidation/reduction: chemical incompatibility I Not applicable to technical gra

Flammability I Not applicable to technical gra

Explodability I N01 applicable to technical gra

Miscibmty I Not applicable to technical gra

Dielectric breakdown voltage I Not applicable to technical gra

Viscosity I Not applicable to technical gra

Boiling pointlboiling range I Not applicable because produc

Particle size, fiber length, and diameter distribution I Not applicable because produc

11 OuV.l<J;JV Partition coefficient (n-octanollwater), shake flask method Addressed under 830.7570 ,,"" 

I OjU.fOOU Partition coefficient generator column method Addressed under 830.7570 

Water solubility: cc!ur.1:1:method Addressed under 830.7840 

12 8:"- ----13 830.7860 

,. .. Nufarm is a member of this tas

....... L7 --------'--'-"-.---;.-:c----:-::::-:--------------

Name and Title Nathan P. Ehresman / Product Registration Manager 

EPA j16rny8'570-35\9.97) Electronic and Paper versions available. Submij only Paper version. Agency Internal Use Co
27

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 
28

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 
29

::;/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 
30

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 
31

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 
Pages 32-33 *Manufacturing process information may be entitled to confidential treatment*
34

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. 
35

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 
36

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 
37

'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 

*Manufacturing process information may be entitled to confidential treatment*
38

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 
Pages 39-42 *Manufacturing process information may be entitled to confidential treatment*
43

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 
44

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 
45

:,\£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. 
46

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~ 

21) .Included in the Submission Package, is it completely X 

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 

Submission Package'? X ~"'~-

Is i.l Lnllcl Included in the Submission Package? -.~---~ 'I 

Are Ihta Included in the Submission Package'? ;< 

Is the Su bmissioll nil Amendment? 
47

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~ _____ _ 

EPAReg.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 

including package type K 

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 

copies (PR 98-5) (Link to PR 98·5) completed and signed (N/A iflOO% V. 

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 
48

- -

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 
49

Comments: 

~5-\1..td\e.s r etss.ed 1ir 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 
50

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 
51

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 
52

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 
53

: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' 

Front 

~V~ 

End Processing Staff 

Information Technology & Resources Management Division 
54

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 
55

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 
56

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 
57

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. 35935M 

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. 
58

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 
59

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 
60

51 , 

F U""" 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 com9i 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 
61

.,.,,0",<,. 

" ft 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 0.25 hours per response for registration a

reregistration and special review activities, including time for reading the instructions and completing the necessary forms. Send comments regarding burden estim

collection of information, including suggestions for reducing the burden to: Director, OPPE Information Management Division (2137), U.S. Environmental Protectio

Washington, DC 20460. Do not send the completed form to this address. 

Date December 16, 2009 

Nufarm Limited 

PO Box 13439 Research Triangle Park, NC 27709 

Ingredient: Metalaxyl 

Guideline Reference Number 1 Guideline Study Name 

OPPTS Series 830 

830.1550 830.1600 

Product Properties 

Product identity and composition 

Description of materials used to produce the 

product 

830.1620 I Description of production process 830.1650 I Description offormulalion process 

830.1670 I Discussion of formation of impurities 830.6302 I Color 

830.6303 Physical state 

830)l&f4 'I I Odo, 

I 'F'r;;L;£iu-_= 

DATA MATRIX 

EPA Reg. No'/File Symbol 35935-

Product 

Metalaxyl Technical 

1 MRID Number I Submitter 

--_.-

47498601 Nufarm Limited 

47498601 Nufarm Limited 47498601 Nufarm Limited 

47498601 Nufarm Limited 

Nufarm Limited 

Nufarm Limited Nufarm Limited 

47498603 Nufarm Limited 

47498603 Nufarm Limited 

47498603 Nufarm Limited 

Name and Title 

Lizbeth Rea, Regulatory Manager 

EPA FormJl8'f0-35 (9-97) Electronic and Paper versions available. Submit only Paper version. Agency Internal Use 

(0 ? ) , ...• / 
62

... w .. 

. .,. , 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 0.25 hours per response for registration 

reregistration and special review activijies, including time for reading the instructions and completing the necessary forms. Send comments regarding burden estim

collection Of jnformation, including suggestions for reducing the burden to: Director, OPPE Information Management Division (2 t37), U.S. Environmental Protectio

Washington, DC 20460. Do not send the completed form to this address. 

DATA MATRIX 

Date December 16, 2009 EPA Reg. No.lFile Symbol 35935- 

Nufarm Limited Product 

PO Box 13439 

Metalaxyl Technical Research Triangle Park, NC 27709 

Ingredient: Metalaxyl 

Guideline Reference Number 1 Guideline Study Name 1 MRID Number 1 Submitter 

830.6313 Stability to normal and elevated temperatures, 47498603 Nufarm Limited 

metals, and metal ions 

830.6314 Oxidation/reduction: chemical incompatibility 830.6315 Flammability 

830.6316 Explodability 830.6317 Storage stability Pending Nufarm Limited 830.6319 Miscibility 

830.6320 Corrosion characteristics Pending Nufarm Limited 

830.6321 Dielectric breakdown voltage 

830.7000 pH 47498603 Nufarm Limited 830.7050 UVNisible absorption 47498603 Nufarm Limited 830.7100 Viscosity 830.7200 Melting pointimeltlng range 47498603 Nufarm Limited 830.7220 Boiling pointlboiling range 830.7300 Densitylrelative densitylbulk density 47498603 Nufarm Limited 830.7370 Dissociation constants in water 47498603 Nufarm Limited 

-_ ... 

EPA Form 8570-35 (9-97) Electronic and Paper versions available. Submit only Paper version. Agency Internal Use 
63

""'," .... 

"A\ UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

401 M Street, S.W. 

WASHINGTON, D.C. 20460 

Paperwork Reduction Act Notice: The public reporting burden for this cOlleclion of information is estimated to average 0.25 hours per response for registration 

reregistration and special review activities, including time for reading the instructions and completing the necessary forms. Send comments regarding burden estim

collection of information, including suggestions for reducing the burden to: Director, OPPE Information Management Division (2 t37), U.S. Environmental Protectio

Washington, DC 20460. Do not send the completed form to this address. 

DATA MATRIX 

Date December 16, 2009 EPA Reg. No.lFile Symbol 35935- 

Nufarm Limited Product 

PO Box 13439 

Metalaxyl Technical Research Triangle Park, NC 27709 

Ingredient: Metalaxyl 

Guideline Reference Number 1 Guideline Study Name L MRID Number 1 Submitter 

830.7520 Particle size, fiber length, and diameter 

distribution 

830.7550 Partition coefficient (n-octanollWater), shake flask 

method 

830.7560 Partition coefficient (n-octanolfwater), generator 

column method 

830.7570 Partition coefficient (n-octanollwater), estimation 47498603 Nufarm Limited 

by liquid chromatography 

830.7840 Water solubility: column elution method; shake 47498603 Nufarm Limited 

flask method 

830.7860 Water solubility: generator column method 830.7950 Vapor pressure 47498603 Nufarm Limited 

40 CFR 158.340 Toxicology 

870.1100 Acute oral toxicity - rat Cite-All 

870. t200 Acute derrnaltoxicity - rabbit Cite-All 

870.1300 Acute inhalation toxicity - rat Cite-All 870.2400 Primary eye irritation - rabbit Cite-All 

870.2500 Primary dermal irritation -rabbit Cite-All 

--_ ... 

EPA Form 8570-35 (9-97) Electronic and Paper versions available. Submit only Paper version. Agency Internal Use 
64

.. 

t',£,'l 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 0.25 hours per response for registration 

reregistration and special review activities, including time for reading the instructions and completing the necessary forms. Send comments regarding burden estim

collection of information, including suggestions for reducing the burden to: Director, OPPE Information Management Division (2137), U.S. Environmental Protectio

Washington, DC 20460. Do not send the completed form to this address. 

DATA MATRIX 

Date December 16, 2009 EPA Reg. No.lFile Symbol 35935- Nufarm Limited Product 

PO Box 13439 

Metalaxyl Technical Research Triangle Park, NC 27709 

Ingredient: Metalaxyl 

Guideline Reference Number ! Guideline Study Name MRID Number ! Submitter 

870.2600 Dermal sensitization - Guinea pig Cite-All 870.5100 Bacterial reverse mutation assay Submitting r..{1q30 fl-oj Nufarm Limited 

Metalaxyl Generic Data Requirements 

Nufarm Limited will make offers-to-pay to the following companies on the data submitters list of March 31, 2008. 

Generic Data Cite-All Syngenta Crop Protection, In

AnN: Regulatory Affairs 

PO Box 18300 

Greensboro, NC 27419 

Bayer CropScience LP 

2 T.W. Alexander Drive 

RTP, NC 27709 

Chemtura Corporation 

AnN: Crop Registration 

1999 Benson Road (2-5) 

Middlebury, CT 06749 

EPA Form 8570-35 (9-97) Electronic and Paper versions available. Submit only Paper version. Agency Internal Use 
65

r"""", 

" ft 'j UNITED STATES ENVIRDNMENTAL 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 0.25 hours per response for registration a

reregistration and special review activities, including time for reading the instructions and completing the necessary forms. Send comments regarding burden estim

collection of information, including suggestions for reducing the burden to: Director, apPE Information Management Division (2137), U.S. Environmental Protectio

Washington, DC 20460. Do not send the completed form to this address. 

DATA MATRIX 

Date December 16, 2009 EPA Reg. No.lFile Symbol 35935- Nufarm Limited Product 

PO Box 13439 

Metalaxyl Technical Research Triangle Park, NC 27709 

Ingredient: Metalaxyl 

Guideline Reference Number .. 1 Guideline Study Name MRID Number 1 Submitter 

Alice Walker Consulting Agent For: Winfield Solutions

3094 Country Club Road 

Senatobia, MS 38668 

Gustafson LLC 

PO Box 660065 

Dallas, TX 75266 

Loveland Products, Inc. 

PO Box 1286 

Greeley, CO 80632 

Trace Chemicals LLC 

2320 Lakecrest Drive 

Pekin, IL 61554-6637 

Sipcam Agro USA, Inc. 

300 Colonial Parkway, Suite 2

Roswell, GA 30076 

EPA Form 8570-35 (9-97) Electronic and Paper versions available. Submit only Paper version. Agency Internal Use 
66

• 

• ' A '< UNITED STATES ENVIRONMENTAL PROTECTION AGENCY \lSI2 ' 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 0.25 hours per response for registration 

reregistration and special review activities, including time for reading the instructions and completing the necessary forms. Send comments regarding burden estim

collection of information, including suggestions for reducing the burden to: Director, OPPE Information Management Division (2137), U.S. Environmental Protectio

Washington, DC 20460. Do not send the completed form to this address. 

DATA MATRIX 

Date December 16, 2009 EPA Reg. No.lFile Symbol Nufarm Limited Product 

PO Box 13439 

Metalaxyl Technical Research Triangle Park, NC 27709 

Ingredien1: Metalaxyl 

Guideline Reference Number 1 Guideline 1 MRID Number 1 Submitter 

Spray Drift Task Force 

1900 K Street, NW 

Washington, DC 20006 Wilfarm LLC 

5401 N. Oak Traffic Way 

Gladstone, MO 64118-4627 

Nation's Ag , LLC 

20 Ambriance Drive 

Burr Ridge, IL 60527 

Biologic, Inc. 

Agen1 for: LG Ufe Sciences, 

115 Obtuse Hill Road 

Brookfield, CT 06804 

Ou1door Residential Exposur

Task Force, LLC 

1350 I Street, NW 

Washington, DC 20005 

-- ---------

EPA Form 8570-35 (9-97) Electronic and Paper versions available. only Paper version. Agency Internal Use 
67

... '.," .... 

,ft· 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 0.25 hours per response for registration a

reregistration and special review activities. including time for reading the instructions and completing the necessary forms. Send comments regarding burden estim

collection of information, including suggestions for reducing the burden to: Director, OPPE Information Management Division (2137), U.S. Environmental Protectio

Washington, DC 20460. Do not send the completed form to this address. 

DATA MATRIX 

Date December 16, 2009 EPA Reg. No.lFile Symbol 35935- Nufarm Limited Product 

PO Box 13439 

Metalaxyl Technical Research Triangle Park, NC 27709 

Ingredient: Metalaxyl 

Guideline Reference Number ! Guideline Study Name MRID Number I Submitter 

Agricultural Reentry Task For

1350 I Street, NW 

Washington, DC 20005 

Nations Ag II, LLC 

4515 Falls of Neuse Road 

Suite 300 

Raleigh, NC 27609 

FIFRA Endangered Species T

Force, LLC. 

1350 I Street, NW 

Washington, DC 20005 

Agricultural Handlers Exposu

Task Force 

PO Box 509 

Macon, MO 63552 

Generic Endangered Species 

Task Force (GESTF) 

500 8 Street, NW 

,. 

Washington, DC 20004 

EPA Form 8570-35 (9-97) Electronic and Paper versions available. Submit only Paper version. Agency Internal Use 
68

""' .. 

(..wi 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 0.25 hours per response for registration 

reregistration and special review activities, including time for reading the instructions and completing the necessary forms. Send comments regarding burden estim

collection of information, including suggestions for reducing the burden to: Director, OPPE Information Management Division (2137), U.S, Environmental Protectio

Washington, DC 20460. Do not send the completed form to this address. 

DATA MATRIX 

Date December 16, 2009 EPA Reg. No.lFile Symbol 35935- 

Nufarm Limited Product 

PO Box 13439 

Metalaxyl Technical Research Triangle Park, NC 27709 

Ingredient: Metalaxyl 

Guideline Reference Number \ Guideline Study Name \ MRID Number \ Submitter 

EXPLANATORY NOTES 

Note Guideline Name afTest Comment 

No. Reference No. 

1 830.1650 Description of production process Not applicable to technical grade active ingredient. Guid

2 830.1900 Submittal of samples Not applicable unless specifically requested by the Agen

3 830.6314 Oxidation/reduction: chemical incompatibility Not applicable to technical grade active ingredient. 

4 830.6315 Flammability Not applicable to technical grade active ingredient. 

5 830.6316 Explodability Not appl'icable to technical grade active ingredient. 

6 830.6319 Miscibility Not applicable t01echnical grade active ingredient. 

7 830,6321 Dielectric breakdown voltage Not applicable to technical grade actlve ingredient. 

8 830.7100 Viscosity N01 applicable to technical grade active ingredient. 

9 830.7220 Boiling point/boiling range Not applicable because product is not a liquid. 

10 830.7520 Particle size, fiber length, and diameter Not applicable because product is not fibrous. 

distribution 

EPA Form 8570-35 (9·97) Electronic and Paper versions available. Submit only Paper version. Agency Internal Use 
69

... " .. 

(£'i UNITED STATES ENVIRONMENTAL PROTECTION AGENCY ;::?' 401 M Street, SoW. 

WASHINGTON, D.C. 20460 

Paperwork Reduction Act Notice: The public reporting burden for this collection of information is estimated to average 0.25 hours per response for registration 

reregistration and special review activities, including time for reading the instructions and completing the necessary forms. Send comments regarding burden estim

collection of information, including suggestions for reducing the burden to: Director, OPPE Information Management Division (2137), U.S. Environmental Protectio

Washington, DC 20460. Do not send the completed form to this address. 

DATA MATRIX 

Date December 16, 2009 EPA Reg. No.lFile Symbol 35935- 

Nufarm limited Product 

PO Box 13439 

Metalaxyl Technical Research Triangle Park, NC 27709 

Ingredient: Metalaxyl 

Guideline Reference Number \ Guideline Study Name I MRIO Number I Submitter 

EXPLANATORY NOTES 

Note Guideline Name of Test Comment 

No. Reference No. 

11 830.7550 Partition coefficient (n-octanollwater), shake Addressed under 830.7570 

flask method 

12 830.7560 Partition coefficient (n-octanollwater), generator Addressed under 830.7570 

column method 

13 830.7860 Water solubility: generator column method Addressed under 830.7840 

EPA Form 8570-35 (9-97) Electronic and Paper versions available. Submit only Paper version. Agency Internal Use 
70

.. 

(..wi UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 401 M Street, S.W. 

WASHINGTON, D.C. 20460 

Paperwork Reduction Act Notice: The public reporting burden for this colieclion of informalion is eslimaled 10 average 0.25 hours per response for regislralion a

reregislralion and special review activijies, including lime for reading Ihe inslruclions and compleling Ihe necessary forms. Send comments regarding burden eslim

colleclion of informal ion, including suggeslions for reducing Ihe burden to: Direclor, OPPE Informalion Management Division (2137), u.s. Environmenlal Proleclio

Washinglon, DC 20460. Do nol send Ihe compleled form 10 Ihis address. 

DATA MATRIX 

Date December 16, 2009 EPA Reg, No.lFile Symbol 35935- Nufarm Limited Product 

PO Box 13439 

Metalaxyl Technical Research Triangle Park, NC 27709 

Ingredient: Metalaxyl 

Guideline Reference Number 1 Guideline Study Name -T MRID Number l- Submitter 

Nufarm Limited Nufarm Limited Nufarm Limited 

Nufarm Limited Nufarm Limited Nufarm Limited 

Nufarm Limited Nufarm Limited Nufarm Limited 

Nufarm Limited 

Lizbeth Rea, Regulatory Manager 

EPA ForrnJW1'0-35 (9-97) Electronic and Paper versions available. Submil only Paper version. Agency Internal Use 

/ '''/ L._ 
71

f" j UNITED STATES ENVIRONMENTAL PROTECTION AGENCY lS!!2 • " .. 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 0.25 hours per response for registration a

reregistration and special review activities, including time for reading the instructions and completing the necessary forms. Send comments regarding burden estim

collection of information, including suggestions for reducing the burden to: Director, OPPE tnformation Management Division (2137), U.S. Environmental Protectio

Washington, DC 20460. Do not send the completed form to this address. 

DATA MATRIX 

Date December 16, 2009 EPA Reg. No.lFile Symbol 35935- Nufarm Limited Product PO Box 13439 Metalaxyl Technical Research Triangle Park, NC 27709 

Ingredient: Metalaxyl 

.. Guideline L r.1 

__ Number ______ 

Nufarm Limited 

Nufarm Limited Nufarm Limited Nufarm Limited Nufarm Limited Nufarm Limited 

Nufarm Limited 

Nufarm Limited 

EPA Form 8570-35 (9-97) Electronic and Paper versions available. Submit only Paper version. Agency Internal Use 
72

.-"''''>;'' 

{ .... , UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

.,.,,,,,,,,"/ :::z ' 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 0.25 hours per response for registration a

reregistration and special review activities, including time for reading the instructions and completing the necessary forms. Send comments regarding burden estim

collection of information, including suggeslions for reducing the burden to: Director, OPPE Information Management Division (2137), U.S. Environmental Protectio

Washington, DC 20460. Do not send the completed form to this address. 

DATA MATRIX 

Date December 16, 2009 EPA Reg. No.lFile Symbol 35935- Nufann limited Product 

PO Box 13439 

Metalaxyl Technical Research Triangle Park, NC 27709 

Ingredient: Metalaxyl 

Guideline Reference Number \ Guideline Study Name \ MRID Number \ Submitter 

Nufarm Limited Nufarm limited Nufarm limited 

EPA Form 8570·35 (9-97) Electronic and Paper versions available. Submit only Paper version. 
73

-r'''''''>- 

(""" 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 0.25 hours per response for registration a

reregistration and special review including Ume for reading the instructions and completing the necessary forms. Send comments regarding burden estim

collection of information, including suggestions for reducing the burden to: Director, OPPE Information Management Division (2137), U.S. Environmental Protectio

Washington, DC 20460. Do not send the completed form to this address. 

DATA MATRIX 

Date December 16, 2009 EPA Reg. No.lFile Symbol 35935-Nufarm limited Product 

PO Box 13439 

Metalaxyl Technical Research Triangle Park, NC 27709 

Ingredient: Metalaxyl 

Guideline Reference Number \ Guideline Study Name \ MRID Number 

EPA Form 8570-35 (9-97) Electronic and Paper versions available. Submit only Paper version. 

\ Submitter 

Nufarm limited 

Syngenta Crop Protection, Inc

AnN: Regulatory Affairs 

PO Box 18300 

Greensboro, NC 27419 

Bayer CropScience lP 

2 T.W. Alexander Drive 

RTP, NC 27709 

Chemtura Corporation 

AnN: Crop Registration 

1999 Benson Road (2-5) 

Middlebury, CT 06749 

Agency Internal Use 
74

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 infonnation is estimated to average 0.25 hours per response for registration a

reregistration and special review activities, including time for reading the instructions and completing the necessary forms. Send comments regarding burden estim

colle cHon of information, includ'mg suggestions for reducing the burden to: Director, OPPE Information Management Division (2 t37), U.S. Environmental Protection 

Washington, DC 20460. Do not send the completed form to this address. 

DATA MATRIX 

Date December 16, 2009 EPA Reg. No.lFile Symbol 35935· Nufarm Limited Product 

PO Box 13439 

Metalaxyl Technical Research Triangle Park, NC 27709 

Ingredient: Metalaxyl 

Guideline Reference Number I Guideline Study Name MRID Number I Submitter 

Alice Walker Consulting Agent For: Winfield Solutions, 

3094 Country Club Road Senatobia, MS 38668 

Gustafson LLC 

PO Box 660065 

Dallas, TX 75266 

Loveland Products, Inc. 

PO Box 1286 

Greeley, CO 80632 

Trace Chemicals LLC 

2320 Lakecrest Drive 

Pekin, IL 61554-6637 

Sipcam Agro USA, Inc. 

300 Colonial Parkway, Suite 2

Roswell, GA 30076 

EPA Form 8570-35 (g-g7) Electronic and Paper versions available. Submit only Paper version. Agency Internal Use 
75

• 

.. ft l 

\.s:!IrZ; 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 0.25 hours per response for registration a

reregistration and special review activities, including time for reading the instructions and completing the necessary forms. Send comments regarding burden estim

collection of information, including suggestions for reducing the burden to: Director, QPPE Information Management Division (2137), U.S. Environmental Protection 

Washington, DC 20460. Do not send the completed form to this address. 

DATA MATRIX 

Date December 16, 2009 EPA Reg. No.lFile Symbol 35935- Nufarm Limited Product 

PO Box 13439 

Metalaxyl Technical Research Triangle Park, NC 27709 

Ingredient: MetalaxyJ 

Guideline Reference Number \ Guidel"lne Study Name \ MRID Number \ Submitter 

EPA Form 8570-35 (9-97) Electronic and Paper versions available. Submil only Paper version. 

Spray Drift Task Force 

1900 K Street, NW 

Washington, DC 20006 

5401 N. Oak Traffic Way 

Gladstone, MO 64118-4627 

IL60527 

Agent for: LG Life Sciences, L

115 Obtuse Hill Road 

Brookfield, CT 06804 

Outdoor Residential Exposure 

Task Force, LLC 

1350 I Street, NW 

Washington, DC 20005 

Agency Internal Use 
76

"" ... 

(eil UNITED STATES ENVIRONMENTAL PROTECTION AGENCY '",_,;;.t 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 0.25 hours per response for registration a

reregistration and special review activities, including time for reading the instructions and completing the necessary forms. Send comments regarding burden estim

collection of information, including suggestions for reducing the burden to: Director, OPPE Information Management Division (2137), U,S. Environmental Protectio

Washington, DC 20460. Do not send the completed form to this address. 

DATA MATRIX 

Date December 16, 2009 EPA Reg. No.lFile Symbol 35935- Nufarm Umited Product 

PO Box 13439 Metalaxyl Technical Research Triangle Park, NC 27709 

Ingredient: Metalaxyl 

Guideline Reference Number \ Guideline Study Name \ MRID Number \ Submitter 

EPA Form 8570·35 (9-97) Electronic and Paper versions available. Submit only Paper version. 

AgricuHural Reentry Task Force 

1350 t Street, NW 

Washington, DC 20005 

Nations Ag II, LLC 

4515 Falls of Neuse Road 

Suite 300 

Raleigh, NC 27609 

FIFRA Endangered Species Task 

Force, LLC. 

t350 I Street, NW 

Washington, DC 20005 

Agricultural Handlers Exposure 

Task Force 

PO Box 509 

Macon, MO 63552 

Generic Endangered Species 

Task Force (GESTF) 

5008 Street, NW 

Washington, DC 20004 

Agency Internal Use 
77

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 
78

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 ... _ ...• " .. --" ... _-" ...... -_._---_. '-'1 

FIRST AID I 

IF SWALLOWED r 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. I 

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

IF ON SKIN • Take off contaminated clothing. 

OR I 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. I 

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

I - 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, _ .. _. _ .. _ .. _ .. - -- _ .. - - - -- ---._- -- ... --,,-.. ~ ---'".~ .... _ ...... _ ... 

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. J --~.~~--~--,~~-.-.. ~.~---.---- ----------------------.--.----~----.----.~-~.---." -~-." .... "'-- ._-- --

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. ' 

2 
79

For 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 .... t 

use the product, and return it unopened to the Seller, and the purchtlse price will be refunded. 

IRV121 . .,09) 

3 

Page 80 - *Confidential Statements of Formula may be entitled to confidential treatment*
Page 80 - *Confidential Statements of Formula may be entitled to co