# EPA Registration Jacket 74530-14

# •

• UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON. D.C. 20460

OFFICE OF PREVENTION. PESTICIDES

AND TOXIC SUBSTANCES Ms. Jeanine Betsher Helm Agro, US, Inc. 

### 8295 TOUm<lfllcnt Drh'c, Suite 31 0 Memphis. TN 38125 Dear Ms. Bctsher: Subject: Helosate 62% MUP (Alternate Fonnulation) EPA Registration No. 74530-14 Application Dated Febmary II, 2004 

### The scientific review and evaluation ofthe alternate confidential statement of fonnula and supporting data submitted above have been completed. The product chemistry data submitted above and the alternate CSF dated February 2, 2004 arc acceptable and our records have been modified accordingly. 

### Sincerely.**'Vl-~h~l_** 

### rUJnLb' __J 

## jr-\J James A. Tompkins C 

### Product Manager 25 Herbicide Branch Registration Division (7505C)



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### AI'Rl2004 J:.'lTnl STxn:s**E:"iVlilO:-;~IE;-':T'\1.** PIWTHTIO:-': ,\GE",n' W,\SIII:-.'{;TO:-l, 

### n.c. 204M

OffiCE OF PREVENrION, PESTICIDES ANO TOXIC SUBSTANCES



### MEMORANDUM 

### Subject:



### From:

To:
Applicanl: 

### Action Desired: EPA Reg. No: Dil Barcode: 

### Dec. No: PC Code: 74530-14 HELOSATE 62 MlJl' D300426 341060 

### 103(,(11 

### Masih I-inshim. Toxicologist Technical Review Branch Registration Division (7505C) Vickie Walfcrs. RM 25 

### J-lerbicidc Branch Rl!gislr;l.lioll Division (7505(') 

### I-Ielm Agro US. Inc
.. Mcmphi,;. TN 38125 Similarity action requested between the basic nnd alternate formulations. 

### FornlllIution: The alternate lormulmion for**#74530~** 

### 14**(2~2~04)** 

### has 62% Glyplmsatc (isopropyJaminc sait). compared to basic 

### formulation (10-13-03) at 100% 

### saIl. 

### RCCOI1Ullcnd,lIions: The basic and Hltcrnatc formulations nrc substantially similar. Thcreli.lrc. the data can be bridged between them. The Signal Word is Clllltion. This memorandum pertains only to the decision concerning whether Ihe subject product is substantially similm to the cited product rrom an at.'ute toxicological view point I'or the purposes orthis action. TRB has made no dctcrminlltions ofthe adequacy orthe toxicological data base or thc precautionary label orthe cited product.



# 3

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# •

• Vickie Waltors 04f2 tl2004 09:46 AM John: To; John ReddenJDC/USEPNUS@EPA 

### cc: Subject: Re: 0300421 74530-12 GlyphosateE::!

The story here is the reviewer for glyphosale (524-420) duming reregistration assigned a non-sentsitzer classification to this product based on information from the MSDS, and did nol ask or require that Monsalo replace the study. Therefore Monsnto was never ask to replace the study. Therefore for 74530·11 we decided to lei Helm have the registration based on the decision for 524·420. I spoke to Jim Tompkins about this again and we decieded thai if that is the only issue we will allow Helm to have their alternate formulations, since they are citing all for their technicaL If you feel the study is necessary we will try to have Monsanto do one. Jim said if any questions see him. If I have totally confused you, let us know and we will try to explain it beller. Vickie Walters John Redden**~** John Redden**~** 04/19f2004 10:27 AM To: Vickie WallerslDC/USEPNUS@EPA cc: Subject: 0300421 74530·12 Glyphosate

..... Forwarded by John ReddenIDCfUSEPA/US on 04f19t04 10:28 AM ••••. Maslh Hashim 041t9f04 10:20 AM To: John ReddenlDC/USEPNUS@EPA cc: Subject: D300421 74530·12 Glyphosate John· Please read this note and send it to Vickie, if it is not confusing
Vickie You have asked for a similarity action for 74530·12 (cited product is 74530·11). The sensitization study was unacceptable. therefore, there was a data gap. To our records. we have not yet received a new study to fill in this data gap. Now, there is more than one Bean asking for a simparity action. All of them will be re;ected for that one (unacceptable) study. If you know that a new (sensitization) study has been received and is in your files please let me know, so that we can approve similarity action for all of them. I hope we can help the situation for the company or 

### Ihe Riant has an acceptable study (that can be cited)
74530·000 t1.wpd



# 4

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# •



# •

• 03/30/04 

### DATE DP BARCODE No.: D300425 EPA REG. NO.: 74530·14 PRODUCT NAME: HELOSATE 62.0% MUP PC 

### Codes 103601 

### Decision No. 341060 FOOD USE 

## I I COMPANY: HELM AGRO ()S. INC. 

# ,1 c 

# ,\3(\v 4

# ~,;~ 

# ,,1\3\101 FROM:

# ,,J~dira Gairola, Chemist

TO: Product Chemistry Team 

### Technical Review Branch/RD (7505C) James Tompkins/ Vickie Walters PM 25 Herbicide BranchlRD(7505C)
INTRODUCTION: HELM AGRO US, INC. has submitted amended Alternate formulation CSF dated 02102/04 

### and Product chemistry Data (MRID #**461983~OI)** 

### for the subject product 

### HELOSATE 62.0% MUP. The source ofactive ingredient is registered (EPA Reg. Nos.**74530~** 

### II
. SUMMARY OF FINDINGS: The submitted Alternate formulation CSF dated 02102/04 

### and Product chemistry Data (MRID # 461983-01) for the subject product HELOSATE 62.0% MUP were reviewed and details 

### will be discussed as follows: I. 

### The Alternate formulation CSF dated 

### 02/02/04 and Product chemistry Data (MRID #461983- 01) for the subject product HELOSATE 62.0% MUP agrees with the product label claim of 62.0 % of the active ingredient Glyphosate isopropylamine salt
. 2. 

### All of the illerts are cleared for the proposed use. 3 Data corresponding to the guideline reference 830.1800 (Enforcement ofanalytical method) satisfY the data requirements of40CFR§ 158.180. HPLC method with UV detector was used for analysis ofGlyphosate isopropylamine salt. 4. Product Chemistry Data corresponding to the Sub Group A satisfY the data requirements of40CFR§ I58. 180. 5. Data corresponding to the Sub Group B satisfY the data requirements of40CFR§ I58.190. 6. Applicant has slated that after 2 years ofstorage under warehouse conditions no product or

# 5

# •

• container degradation was seen for Glyphosate 41.0%
. Storage Stability and Corrosion Characteristics (830.6317), (830.6320) study is satisfied. 7. The Alternate fannulation CSF dated 02/02/04 and Product chemistry Data (MRID 

### #**461983~O** 

### I 

### for the sllbject product 

### HELOSATE 62.0% MUP are 

### acceptable.
CONCLUSIONS: TRB has reviewed the submitted Alternate formulation CSF dated 02/02/04 

### and Product 

### chemistI)' Data (MRID #**461983~O** 

### I) for the subject product HELOSATE 

### 62.0% MUP product and has concluded that: I. The Alternate fomlUlation CSF dated 02/02104 

### and Product chemistry Data for the subject product HELOSATE 62.0% MUP are acceptable
.



# 6**~~~~~~~~--------------------'**

# aEPA Iiniled Statn Environmental Protection Agency Wuh'ngton, ac 20460



### , for 

# '"



# - Registration Amendment 

### Other I opp tdBntifi", Numb

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t. CompnnvlPIOduct Numb", 2. EPA P,,,duCI Manog", 

## !3.**Propu~"d** CIIIUilic&l,i&n

### 74530-~14'--_~_____________________

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# r--J**R"Slricl~** 4. C"r>lpuhyIPrnduct {Nam,,' 'PM' 

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-- HELOSATE 62% MUP ______ -j1..:2=5____

## ~_____ 

### ____.J___ is_

### ~II';'''**IIn~ Ad;,;~·;:;-Apphcllnl**  !fr>clude ZIP

### -C'Jd~f 

## ;6. Expedited Reveiw. In accordance wilh F!FRA Section 3(c){3)

Helm Agro Us. Inc ' (b)fi), mV product is similat Of idetltical in compasilion and labeling 8295 Tournament Drive, Suite 310 to:**,.,o"'""~c!N** 38125 EPA Reg. No. __**~**_____**~**__**~_~~**_____**~** 

## 1---1 Ch"cJ: (f this"
.. n"w addr.ss Product Name

### ~J Amendment EXI.I"in below. 

# rr::-)**R"~ubmiS5tOn** In**'''~II''r>Il''** 10 Agency**l"It~'** allhld

r--) Nnl,t,enli"n
- ExplA,n 1I"low.

AL TERNATE FORMULATiON

EPA Fo,m 8570·111'hv
. .J-S4t • eOilions "'" "b,,,1.1e. 

### , - IIfinal prinl$d IAb"I" on 'ep_onu to 

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. Exph.in b"low.

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- EPA file Copy**lori~IIl)** 

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7

# •

• UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D,C. 20460



### March 9, 2004


### HELM AGRO US. INC. 

### 8295 TOURNAMENT DRIVE. SUITE 310 MEMPHIS. TN 

### 38125- Report ofAnalysis for Compliance with PR Notice 86-5 OFFICE OF )'IIEVE:-JTll):-':,I'ESTlCIl1),S .\-"n T();\W SL!BST,\'-':CES



### Thank you for your submittal of 17-FEB-04. Our staffhas completed <l 

### preliminary 

### <Inalysis oCthe material. The results arc provided as follows: Your submittal was found to 

### be in 

### filii compliance with the standards for submission of Ci<lt,l 

### contained in PR Notice 86-5, A copy oryom bibliography is enclosed. annotated with MaSlCr Record ID's (MRIDs) assigned to each document submitted. Please lise these numbers in an finurc 

### references to these documents, Thank you 

### for your cooperation. 

### JrYOl! have any 

### questions concerning this data 

### submission, please 

### r<lise them with the 

### cognizant Prodllct Manngcr. to whom the data have been 

### relc<lscd



# 8

# ••



# • February II, 2004



### Document Processing Desk Registration Division (7505C) U.S. Environmental Protection Agency Room 266A. Crystal Mall 2 

### 1921 Jefferson 

### Davis Highway Arlington. VA 22202-4501 

# HELm FlGRO US, INC. 8295 T oumoment Drive, Suite 31 0 Memphis. Tennessee 38125 Phone: 19011312. t525 Fax; 19011312.1535



### Rc: Hclosate 62% MUP, EPA Reg. No. 74530-14
- Alternate Fonnulation Dear Mr. Tompkins: 

### HELM is 

### making the enclosed submission for an alternate formulation ofour Helosate**62~o** 

### MUP. 

### EPA· Reg. No. 74530-14. Enclosed you will find the following: I. Application for Registration 2. Confidential Statement ofFormula 3. Draft labeling and identical label on CD (in pdf

### & WordPerfect fannats)



### [The draft label is idelllicallo 

### the labelforHELOSATE 62%MUP 74530-14. amended 10 

### include commentsper theAgency's letter of rOl;d;r;onal reg;slrar;oll datedNovember 19, 2003.] 

## 46198301 4. product ChemistO\ Manufacturing Process. Discussion of Impurities
.. and the relevant 

# • Confidential Attachment We would appreciate an EXPEDITED review ofthis submission. Please do not hesitate to contact me ifyou require anything further. Thank you in advance for your prompt attention to this submission. Sincerely,

# J~~.4,,--_ Jeanine Betsher Regulatory Affairs



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### 74530-14

## \m~ WdBhin;)tOrl. D,C, 20460

### +~~! Mf)'ll,';ff Term of Inso"nc", NOTICE OF PESTICIDE: 

### Registration C-onditional -2L

- 

### Reregistration Nam" of**P"~t!clde** Prod"cl: _""dcr FlFRA, <>11 amended) 

### Helosate 62% MUP llJIllf' and I\ddre611 or**R"g,slr~nr.** ;-;",,1"'1(; ZIP Cod,,;, 

### Helm Agro US, Inc 

### 8295 Tournament Drive, 

### suite 310 Memphis, TN 

### 38125 Kot., Ch,mgC(l in labeling differing in aubstancc fl"om that accepted in conoectlon with this regi:nr"tion mOIll be**~obl\lirted** 10 and accepred by the Regil:ltracton Oivilll0n prior 10 

### '''''I of th'l l"bel in COI!Ir:l<lr!,e, In
..oy correspondence on this prQdoct always refer 10 tho above EPA re9intraelon**numb~r,** On the**b~G!~** or ,nforlMelOn f",""Ished by Ihe r""Haraoe, Ihe above n.>med**p~!ll,Ic'd"** 

## " hereby ,.egiSle,."d/rer<::glulered ur.de" Ihe F'edentl tn""ct ic ld", Fo09<'G,de ,lnd**t~odeotidd"** "-<:1
. Re9,sH'auon in '" no ",ay 1 

### °**b~** conal rued ,,0 ilf' eodorgell'
. .,nt or reG0r=eodal ion of tluo prodocl by the Agency in order lC prote:Cl henllh "nd the env,ro"men!, Ihe Adml",,,er"lor, on hUI CIOtlon, "''>1' 

# "' "01' lIme """pend or c ..ncd 111(, r"g'Btl,.,,,,Ol< ,jf" penl1C'lrle ill ,1CCot'dance ,..,lh Ih., Act,**Th~** d("C"pl "nCe of "ny nan'e 'n coooecllon ,..Utl**th~** r"9'9tr"elOll ot "**I'~od"ct** onder Ihis A,:t !:}**~ot ~D**  be CO'H11.-u"d**a~** g!Vlng I.he**rcg\~cn:"'r.** " right 00 !'xchwive use of l1le**f""'''~** or to !tu**u~e** 

## ,

# , I l. h"n**b~"n cove~ed**  by**Olh"~,,.** 

### This product is conditionally registered in accordance with FfFRA section 3{e)(7)(A)provided that you: L 

### SubmiUeitc all data required for registration/reregistration ofYOllr product when the Agency requires all registrants ofsimilar products to submit such data. 2. Make the labeling changes listed below before you release the product for shipment. 

# • a. Add the phrase "EPA Registration No. 7430-14." b
.. Under "Storage and Disposal". revise "Storage" to read "Pesticide Storage", revise "Disposal" to read "Pesticide Disposal" and add the subheading "Container Disposal" 3. Submit three copies of your final printed labeling before YOli release the product for shipment. Ifthese conditions are not complied with, the registration will be subject to cancellation in accordance with FIFRA Section 6 (c), Your release for shipment ofthe product constitutes acceptance ofthese conditions, A stamped copy or labeling is enclosed for yom records.

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• HELOSATE 62% MUP Active Ingredient Glyphosate: N-(phosphonomethyl) glycine, in the fonn ofils isopropylamine salt
............................ 62.0% Inert Ingredients:
...................... , ..................................... ,................. 38.00/0 TOTAL.
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. 100.0% Contains 769 grams per liter or 6.42 pounds perU.S. gallon of the active ingredient glyphosate in the fonn ofils isopropylaminc sail. EquivalclI\ to 570 grams per liter or 4.75 pounds per U.S. gallon of the acid glyphosale. EPA Reg. No. 74530- EPA Est. No. 

## KEEP OUT OF REACH OF CHILDREN CAUTION! PRECAUTIONARY STATEMENTS HAZARDS TO HUMANS AND DOMESTIC ANIMALS CAUTION Keep out ofreach ofchildren. ENVIRONMENTAL HAZARDS 

### 1dt:h 

### COMR1EN'IS In**I~PA !~etter**  '),;;')< ,I, 

## DEC 17'" Veuti" tim Fclc,.:j**~i:u.X ~a,**  muI RoJOtllid,:t.**i4:;~** as WlleJlded, far the iilCSfl::;:h 

# """"'1**q~ ,,~a,iR"'"**  fie, Do not discharge effluent containing this product into lakes, streams, ponds, estuaries, oceans or otherwaters unless in accordance with the requirements of a National Pollutant Discharge Elimination System (NPDES) permit andthe pennittingauthorityhas been notificd in writing prior to discharge. Do not discharge effluent containing: this product to sewer systems without previously notifying the local sewage treatment plant authority. Forguidance contactyour State Water Board or Regional Office of the EPA
. PHYSICAL OR CHEMICAL HAZARDS Solutions ofthis product should be mixed, stored and used only in stainless steel. aluminum, fiberglass. plastic, or plastic-lined containers. DO NOT mix, store, or utilize this product or solutions ofthis product in galvanized steel or unlined steel (except stainless steel) containers or tanks. This product or solutions ofthis product react with such containers and tanks to produce hydrogen gas which may fonn a highly combustible gas mixture. This gas mixture could flash or explode. causing serious personal injury, ifignited by open flame, spark, lighted cigarette, welder's torch or other ignition source. In case ofspill or leak, soak up and remove to a landfill. FOR CHEMICAL EMERGENCY: Call CHEMTREC 1·800-424-9300. DIRECTIONS FOR USE It is a violation ofFederal Law to use this product in a manner inconsistent with its labeling. Use only for manufacturing and fonnulating into herbicides through dilution and blending. This product may only be refonnulated or repackaged into a hcrbicide for use in aquatic, industrial, turf, ornamental nursery, tree and forestry, including eucalyptus and Christmas trees, and residential sites; fallow land and fallow bed; or some or all ofthe following food cropping systems: root, bulb, and tuber vegetables, leafy vegetables, brassica and cucurbit vegetables, succulent and dried legume vegetables, fruiting vegetables. fruits (citrus, pOllle, stone, various tropical fruits, small fiuits and berries), tree nuts, cereal grains, animal grasses and forages, herbs, spices, and food crops including asparagus, avocado, banana. canola., coffee, cotton, coconut, cranberry, dates, flax, grapes, kiwi, Iychee, mints, 01 ive, palms, peanut, pineapple, soybeans, strawberry sugarbeet, sugarcane, and tea. STORAGE AND DISPOSAL • • Do not contaminate water, foodstuffs, feed, or seed by stomge or disposal. : ••••• Storage: Store above 32°F (O"C) to keep from crystallizing. Crystals will settle to the bottom. Ifallowed to Cl)'StaJijiQr, wann to 68°F (20QC) and mix well or recirculate to redissolve before using. • ••••• Disposal: Wastes resulting from the use ofthis product that cannot be used or chemically reprocessed should bedisp.sed ofin
...... landfill approved for pesticide disposal or in accordance with appl icable Federal, state or local procedures. •• :. : Emptied container retains vapor and product residue. :..... • ••••• Observe all labeled safeguards until container is cleaned, reconditioned, or destroyed. •••• •••• Triple rinse emptied container. Then offer for recycling or reconditioning, or dispose ofin a manner approved by**sta~d** 10c,Ie ••• authorities. • ••: ••• 

## •••• o 0 CONDITIONS OF SALE AND WARRANTY •••• HELM AND SELLER OFFER THIS PRODUCT AND THE BUYER AND USER ACCEPT THIS**PRODUC~**tJ@;RTHE FOLLOWING AGREED CONDITIONS OF SALE AND WARRANTY. •• •• HELM warrants only that this product confonns to the chemical description on the label and is believed to be reasonably fit for the purposes referred to in the Dircctions for Use when used as directed under normal conditions. HELM MAKES NO OTHER EXPRESS OR IMPLIED WARRANTY OF FITNESS OR MERCHANTABILITY OR ANY OTHER EXPRESS OR IMPLIED WARRANTY. In no case shall HELM or the Seller be liable forconsequcntial, spedal, or indirect damages resulting from the use orhandling ofthis product. Any variation or exception from this warranty must be in writing and signed by an authorized HELM representative. HELM AGRO US, INC. 8295 Tournament Drive, Suite 310 Memphis, Tennessee 38125 

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October 22. 2003 U1T1U'l)r I'Rl'VLN nOK l'ISIIC]IlI'." ,\SII IOXIC SI:nSTA;-.:CI,S 

### JEANINE BETSIIER IIELM AGRO US. INC. 8295 TOURNAMENT DRIVE. SUITE 310 iv1Etv1PIIIS, TN 38125-


### PRODUCT NAME: IIELOSATE 62 MlJl' COMPANY NAME: HELM AURO US. INC. EPA FILE SYMBOl.: 74530-RlJ EPA RECEIPT DATE: 11J1I710} SUBJECT: RECEIPT OF APPLICATION FOR A NEW REGISTRATION DEAR REGISTRANT: The Offiee uf I\:sticidc Programs has**ree~ivcd** your application for a neW rcgistration lUlU it has passed 

### an administrative screen for completeness. 

### Please notc that this is onlY'l lIotiiic<ltion orreceipt of

### your application. This is only the first $tcp iuthc application process and dncs NOT constitllte aJiProval. Ifyuu h;1V(': allY qw.:stiol1s. picasI..' contncl Registration Division. Risk ivlanagcmcnt Team 

### 25. at (703) 305-5697. Sincerely. 

# 11[;;.,.""..;It·**7k~** Front EmI Processing Staff Information Services Brandl IllrOl'lllutioll Resources aIHI Services Di visiol1



# 13

# • HELm RGRO US, INC.

October [6. 2003
Document Processing Desk (APPL) U,S. Environmental Protection AgeHcy Room 266A. Crystal Mall 2 J 

### 92 [ Jefferson 

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### i-Iwy. Arlington, VA 22202-450 [
Rc: Helos-ate 62 1 ;;0 MUP**~** Repack Suhmission


### Attn: Mr. Jim Tompkins I 

### PM 25 8295 Tournament Onve. 5Ulte 310 MemphiS. Tennessee 38125 Phone. [901 [312.1525 Fax [901]312·1535



### HELM ACiRO is enclosing a sllbmission for the registration uf {-Idos-ate**62~1)** 

### MUP, EPA File Symb()j**74530~.** 

### The pmJlU.:t 

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### EPA Registration No,
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### Enclosed you will lind the iollnwillg: 

### I. Application fix Registration ofHdosatc 62%) MUP. EPA Fonn 8570-[ 2. Contidcntial Stotcment ofFonllu!a, EPA Form 8570-4 3. Formulator's Exemption Statement. EPA Form 8570-27 4. Three copies orproposed lubeling and idcntit:al label 011 

### CO (in pJfand WordPertt:cI !tlllnats) For yom info01Hltion. since this submission is a repaek of
. EPA Reg. No.
. we hnvc based Ollr dran label on the must recently approved label that was posted Oil the PPLS wehsite. 

## • • •• •••• 

## • We WOllid appreciate un EXPEDITED review ofthis sllbmission. 

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### • •••••• Please do not hesitate to contact me ifyml require anything tlll1hcr. prompt attention to this submission. Sincerely. Je,millC Bctshcr RcgulatOl)' Atfairs Thank yOlI 

### in advan<O.c 10' vOllr: .: 

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### 25 S. Nomo and Add,oss of Applicant (Include ZIP Cod" 6. Expedited Reveiw. In accordance with FIFRA Section 31c1l3) Helm Agro US, Inc. tb)lil. my product is similar Of identical in composilion and labeling 8295 Tournament Drive, SUite 310**t~,.** Memphis, TN 38125 EPA Reg. No. 

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# , , ; "N'm'" Helm Agm US. Inc 74530, 8295 Tournament Drive, Slilte 310 Memph,s. Tennessee 38125 Product N.me Helosate 62% MUP 

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Octooor 13. 2003 As an authorized representative of the applicant for registration of the product identified above, , certify that:

III This product contains the fonowing active ingredientls!: glyphosale, N·{phosphOllorrwlhy!) glycme

121 Of these. each active ingredient listed in paragraph (4) is present solely as the result of the use of that active ingredient in the manufacturing, formulation or repackaging another product which contains that active ingredient which is registered under FIFRA Section 3, is purchased by us from another producer, and is labeled for at least each use for which my product is proposed to be labeled. 131 Indicate by chocking IAI or (e) below which paragraph applies:

## ~ IAI An accurate Confidential Statement of Formula (EPA FORM 857(}'4) for the above identified product is attached to this statement. That formula statemont indicates, by company name, registration number, and product name, the source of the active ingredientis) listed in paragraph (1), 

# D OR IB) The Confidential Statement of Formula ICSFI IEPA Form B570·41 referenced above and on file with the EPA is complete, current, and accurate and contains the information required on the current CSF. (4) The following active ingredients in this product Qualify for the formulator's exemption.
Active tnllt"t.nt Product N_**ft.gi.tr~on** Numb.r glyphn5atc" N'lphosplll:mOml,llhyl) gtycine

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