# EPA REGISTRATION FILE #74530-37

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# 7 74530-3

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### 009279343U.S. Environmental Protection Agency OfficeofPesticidePrograms Registration Division (7S0SP) 1200 Pennsylvania Ave., N.W. Washington, D.C. 20460 

### NOTICE OF PESTICIDE:

(underFIFRA, as amended) 

### X Registration

_ Reregistration

Name and Address ofRegistrant (include ZIP Code): 

### Helm Agro Inc. 8295 TournamentDrive, Suite 310 Memphis, TN 38125 EP. Date ofIssuance: Number: 

### 74530-37 

### 1 5 

## 2009

TermofIssuance: 

### Conditional
Name ofPesticideProduct: 

### ParaquatTC (Technical Concentrate)

On the basis ofinformation furnished by the registrant, theabove namedpesticideis hereby registered/reregisteredunderthe Federal'Insecticide, Fungicide and Rodenticide Act. Registration is in no way to be construed as an endorsement orrecommendation ofthis productby the Agency. In ordertoprotect health and the environment, the Administrator, on his motion, may at any time suspendorcancelthe registration ofapesticide in accordance withthe Act. The acceptance ofany name in connectionwiththe registration ofaproductundertltis Act is notto be construed as giving the registrant arightto exclusive use ofthe name orto its use ifithas been covered by others. 

### Thisproductis conditionallyregisteredinaccordance with FIFRA section 3( c)(7)(A) provided you agree in 

### writingto: 1. Submitthe outstanding datarequirements 830.6317 Storage Stability and 830.6320 Corrosion Characteristics within oneyear from the date ofthis letter. 2. Revise the EPARegistrationNumberfrom 74530-xx to 74530-37 onthe label. 3. Add an appropriate EPAEstablishmentNumberto the labeL 4. Add appropriate Net Contents information to the label.

Date: 

# /- /5
-

# 01

EPA Form 8570-6 

# 2

### page2 EPA Reg. No. 74530-37 Thebasic formulation CSF [datedJune 6, 2008] oftheproductreferredto above, submitted in connection withregistrationunderthe Federal Insecticide, Fungicide, andRodenticide Act is acceptable. Thebasic CSFwillbeaddedto your file. Please seethe attached Confidential Appendixregarding one ingredientinyour formulation. Youwill submit one (1) copyofyour final printed labelingbeforeyoureleasetheproduct for shipment. Ifthese conditions are not compliedwith, theregistrationwill be subjectto cancellation in accordancewithFIFRAsection 6(e). A stamped copyoflabeling is enclosed for yourrecords. Ifyouhave anyquestions, please contact HopeJohnson at 703-305-5410.

J

### ames Tompkins Product 11anager (25) HerbicideBranch Registration Division (7505P)

# Paraquat TC (Technical Concentrate) ForFonnulationofParaquat Herbicide Products Only ACTIVE INGREDIENT Paraquat dichloride (l,l'-demetbyl, 4,4'-bipyridinium dichloride) INERT INGREDIENTS TOTAL Contains 3 pounds paraquat cationper gallon. Contains emetic. EPAReg. No. 74530-xx EPAEstablishmentNo. 

## KEEP OUT OF REACH OF CHILDREN DANGERIPELIGRO 

## POISON 43.8% 56.2%

Si usted no entiende laetiqueta, busque a alguien paraque se la explique a usted endetalle. (Ifyou do not understand the label, fmd someone to explain ittoyou in detail). • NEVERPUT INTOFOOD,DRINKOROTHER CONTAINERS • IF SWALLOWED, TAKE IMMEDIATE ACTION AS PRESCRIBED IN FIRST AID STATEMENT.SYMPTOMSAREPROLONGED ANDPAINFUL. NetContents:

HELM AGRO Inc. 8295 TournamentDrive Memphis, TN, 38125 info@helmagro.com

1 ACCEPTED with COMMENTS In EPA Letter Dated

H: 

## 1 5 2009 Under the Federal Insecticide fungicide, !JJ1d Rodenlitide Act as .tUnended,. for. !he p.isticide**refPst~rod** !l11di:r ePA**~.** NQ.



# _**i~S~g~~l_**

### FIRST AID ! Ifswallowed 

# • Speedis essential. Immediate attentionis required. Ifavailable, Give an adsorbent such as activated charcoal, bentonite or Fuller's Earth. 

## • Call apoisoncontrolcenterordoctor immediately fortreatment. 

## • Donot give anythingbymouthto anunconscious person. Ifineyes 

## I 

## • Hold eye open and rinse slowly and gently with water for 15 to 20 mins. Remove contact lenses, ifpresent, after the first 5 minutes, then continuerinsing eye. 

## • Call a poisoncontrolcenterordoctorfor treatment advice. Ifinhaled 

## • Movepersonto fresh air.

! 

# • Ifpersonis notbreathing, call 911 oran ambulance. 

## • Call apoisoncontrol centerordoctorfor furthertreatment advice. Ifonskin orclothing 

## • Take offcontaminated clothing. 

## I 

## • Rinse skinimmediatelywithplenty ofwater for 15 to 20 minutes. 

## • Callpoison control centerordoctorfortreatment advice. 

### ! NOTE TO PHYSICIAN

Administer either activated charcoal (100g for adults or 2glkg body weight in children) or Fuller's Earth (15% solution: lliterfor adults or 15mglkgbodyweight inchildren. Note: The use of gastric lavage without administration of an adsorbent has not shown any clinical benefit. Donotuse supplemental oxygen. Eye splashes from concentratedmaterial shouldbe treatedby an eye specialistafter initial treatment. With the possibility oflate onset corneal ulceration, itis advised thatpatients with paraquat eyeinjuries are reviewedby aneye specialistthe dayafter firstpresentation. Use treatment that is appropriate for chemical burns. Intact skin is an effective barrier to paraquat, howevercontact with irritated orcut skin orrepeatedcontactwith intact skin mayresult inpoisoning. Have the product container or label with you when calling a poison control center or doctor, or going for treatment. 

### HOTLINE For medical emergencies involving this product, call CHEMTREC 1-800-424-9300. For chemical emergency: Spill, leak, fire, exposure, oraccident, call CHEMTREC 1-800-424-9300

2

### PRECAUTIONARY STATEMENTS HAZARDS TO HUMANS AND DOMESTICANIMALS DANGERJPELIGRO POISON



# :t:

May be fatal ifswallowed. Corrosive. Causes irreversible eye damage. Fatal ifinhaled. Do not breathe spray mist or inhale contaminated dust. Do not get in eyes or on clothing. Harmful ifabsorbed through skin. Avoid contact with skin. Wear goggles, face shield or safety glasses. Prolonged or frequently repeated skin contact may cause allergic reactions in some individuals. Wash thoroughly with soap and waterafterhandling andbefore eating, drinking chewing gum orusing tobacco. IMPORT ANT: The effect ofswallowing paraquat concentrate is far more severe thanthat which usually results from skin contact or inhalation ofcontaminatedplant dust. This product should not cause injury if used according to label instructions. When handling ormixing concentrate orwhenexposureto concentrate is possible, wear: • Dust/mistfilteringNIOSH approvedrespiratorwith any R,P orHEfilter • Protective clothing (disposable suit/coveralls orlong-sleeve shirtand longpants) • Full face shield • Chemical-resistantgloves (CategoryA) • Chemical resistantapron and shoes plus socks Wash handsbefore eating, drinking, chewing gum, using tobacco orusing the toilet. REMOVE contaminated clothing and wash separately from otherlaundrybefore reuse. 

### ENVIRONMENTALHAZARDS This product is toxic to wildlife. Do not discharge effluent containing this product into lakes, streams, ponds, estuaries, oceans, orpublic waters unless this product is specifically identified and addressed in a National Pollutant Discharge Elimination System (NPDES) permit. Do not discharge effluent containing this product to sewer systems without previously notifying the sewage treatment plant authority. For guidance, contact your State WaterBoard orRegional Office ofEPA. 

### PHYSICAL AND CHEMICALHAZARD This product reacts with aluminum to produce hydrogen gas which may form a highly combustible gas mixture. Do notmix or store in containers, tanks, orsuch systems made ofaluminum orhaving aluminum fittings. 

### EQUIPMENT/CONT AINER Flush all equipment with water after use each day. Paraquat is corrosive to aluminum. Aluminum equipment and aluminum structures that are exposedto solution or spillage should be flushed thoroughly with water immediately after use. 

### SPILLAGEDURING TRANSPORT

3

### Emergency Action: Notify police and fire departments immediately. For any spill, leak, fire, or exposureintheUnited States, call CHEMTREC 1-800-424-9300. KEEP PUBLIC ANDANIMALS awayfrom area. MARKROADS ANDWARN OTHERROAD USERS. WEAR face shield, chemical-resistant gloves, chemical-resistant footwear, and long-sleeve shirt and long pants during decontaminationoperations. Clean up spills as soon as possible. Cover spill with generous amount of clay or loam soil to absorb liquid, using a stiffbroom to ensure intimate contact. Sweep onto shovel and transfer to plastic bag or other disposable container. Repeat operations until contaminated surfaces are dry. Finally, hose spill site withwater, iffeasible. 

### DIRECTIONS FORUSE Itis a violation ofFederalLawto use thisproductin a mannerinconsistentwith its labeling. 

### READ ENTIRE LABEL. USE STRICTLY IN ACCORDANCE WITH PRECAUTIONARY STATEMENTS AND DIRECTIONS, AND WITH APPLICABLE STATE AND FEDERAL REGULATIONS. Onlyfor formulation into a herbicide for the following uses: 

### TERRESTRIALFOOD CROP Acerola (West Indies cherry), apricot, asparagus, avocado, banana, blackberry, blueberry, boysenberry, broccoli, cabbage, Chinese, carrot (including tops), cauliflower, cherry, cocoa, coffee, collards, cucumber, eggplant, fig, filbert (hazelnut), garlic, groundcherry (strawberry tomato/tomatillo), guava, hops, kiwifruit, lettuce, loquat, macadamia nut (bushnut), manioc (cassava), melons, melons, cantaloupe, melons, musk, melons, water, mint, nectarine, olive, onion, papaya, passion fruit, peach, pear, pecan, pepino (melonpear), pepper, pepper (chili type), pineapple, pistachio, plum, potato, whitlIrish, prune, pumpkin, raspberry (black, red), rhubarb, small fruits, squash (all or unspecified), strawberry, sugarbeet, taro, walnut (Englishlblack), yam, yautia. 

### TERRESTRIALFOOD

### +FEED CROP Almond, apple, barley, beans, asparagus, beans, dried-type, beans, mung; beans-succulent (lima); beanssucculent (snap), citrus fruits, com (unspecified), com, field, com, pop, com, sweet, cotton (unspecified), garbanzos (including chickpeas), grapes, guar, hops, legume vegetables, mint, orchards (unspecified), peanuts,peanuts (unspecified), soybeans, edible, spearmint, sugarbeet, sugarcrops, sugarcane, sunflower, tomato, turnip, vegetables (unspecified), wheat. 

### TERRESTRIALFEED CROP Alfalfa, barley, beans, clover, crownvetch, legume vegetables, lespedeza, lupine, pastures, sainfoin, timothy, trefoil, tyfon, vetch, wheat. 

### TERRESTRIALNON-FOOD CROP Agricultural fallow/idleland, airports/landingfields, commerciallindustriallawns, commercial/institutionallindustrial,premises/equipment (outdoor), fencecrowslhedgerows, grasses grown for seed, industrial areas (outdoor),jojoba, nonagricultural outdoorbuildings/structures, nonagricultural uncultivated areas/soils, ornamental and/or shadetrees,peach (non-bearing, seedbeds), recreation area lawns, tomato (post-harvest)/woodprotection treatmentto forest products (seasoned).

4

### FORESTRY Forestplanting (reforestationprograms), pine (forestlshelterbelt), shelterbelt plantings. 

### TERRESTRIALNON-FOOD Ornamental and/or shade trees, ornamental herbaceous plants, ornamental woody shrubs and vines, noncrop areas suchaspublic airports, electric transformer stations and around commercialbuildings. 

### OTHERS Uses for which USEPA has accepted the required data and/or citations ofdata that the formulator has submitted in support of registration; and uses for experimental purposes that are in compliance with USEPArequirements. 

### STORAGEAND DISPOSAL Do not contaminate water, food orfeed by storage, ordisposal. PESTICIDE STORAGE; Store at temperatures above 32° F. Do not contaminate food, foodstuffs, or drinking water. Do not store next to feed orfood, or transport in or on vehicles containing foodstuffs or feeds. Forhelp with any spill, leak, fire or exposure involving this material, call CHEMTREC 1-800-424- 9300. PESTICIDE DISPOSAL; Pesticide wastes are acutely hazardous. Improper disposal ofexcess pesticide or rinsate is a violation ofFederal law. Ifthese wastes cannot be disposed ofby use according to label instructions, contact your State Pesticide or Environmental Control Agency, or the Hazardous Waste representative atthe nearestEPARegional Office for guidance. CONTAINERDISPOSAL: Triple rinse (or equivalent). Offer for recycling orrecondition, orpuncture and di.spose of in a sanitary landfill, or dispose of by other procedures allowed by State and local 

## I authonhes.

. CONDITIONSOF SALE AND LIMITATIONOFWARRANTY AND LIABILITY NOTICE: Read the entire Directions for Use and Conditions ofSale and Limitation ofWarranty and Liability before buying orusingthisproduct. Ifthe terms are not acceptable, return theproduct at once, unopened, and the purchase price willberefunded. The Directions for Use ofthis product must be followed carefully. It is impossible to eliminate all risks inherently associated with the use of this product. Crop injury, ineffectiveness or other unintended consequences may result because of such factors as manner of use or application, weather or crop conditions, presence of other materials or other influencing factors in the use ofthe product, which are beyondthe control ofHelm Agro US, Inc. or Seller. To the extentconsistentwith applicable law, all such risks shall be assumed by Buyer and User, and Buyer and User agree to hold Helm and Seller harmless for any claimsrelating to suchfactors. Helmwarrants thatthis product conforms to the chemical description onthe label and isreasonably fit for the purposes stated inthe Directions for Use, subjectto the inherent risks referred to above, when used in accordance with directions under normal use conditions. This warranty does not extend to the use ofthis product contrary to label instructions, or under abnormal conditions or under conditions not reasonably foreseeable to or beyond the control ofSeller or Helm, and Buyer and User assume the risk ofany such use. TO THE EXTENT CONSISTENT WITH APPLICABLE LAW, HELM MAKES NO WARRANTIES OF MERCHANTABILITY OR OF FITNESS FOR A PARTICULARPURPOSE NORANY OTHEREXPRESS ORIMPLIEDWARRANTY EXCEPTAS STATEDABOVE.

5To the extent consistentwith applicable law, inno event shall Helm or Sellerbe liable for any incidental, consequential or special damages resulting from the use or handling ofthis product. TO THE EXTENT CONSISTENT WITH APPLICABLE LAW, THE EXCLUSIVE REMEDY OF THE USER OR BUYER, AND THE EXCLUSIVE LIABILITY OF HELM AND SELLER FOR ANY AND ALL CLAIMS, LOSSES, INJURIES OR DAMAGES (INCLUDING CLAIMS BASED ON BREACH OF WARRANTY, CONTRACT, NEGLIGENCE, TORT, STRICT LIABILITY OR OTHERWISE) RESULTING FROM THE USE OR HANDLING OF THIS PRODUCT, SHALL BE THE RETURN OF THE PURCHASE PRICE OF THE PRODUCT OR, AT THE ELECTION OFHELM ORSELLER, THE REPLACEMENT OF THE PRODUCT. Helm and Seller offer this product, and Buyer and User accept it, subject to the foregoing conditions of sale and limitations ofwarranty and ofliability, which may notbe modified exceptby written agreement signedby a duly authorizedrepresentative ofHelm. DRAFT submittedto EPA: 06-05-2008; revised andresubmittedto EPA on01-06-09

6

### CONFIDENTIALAPPENDIX: 

### Pleasenotethat oneinertingredientin than orequal ....V.l.VL<UH

### is limitedto less



# ItJ"Bert Volger" <bertvolger@comcast.net> 01/13/200904:43 PM Please respond to <bertvolger@comcastnet>

Dear Ms. Johnson, To Hope Johnson/DC/USEPAJUS@EPA cc "'Marshall Wixson'" <mwixson@helmagro.com> bcc Subject RE: 74530-GT data matrix revisions

Thanks for your thorough review and the provided comments. Attached you will find an updated Data Matrix (Agency and Public Copy)

. Please let me know, if there are any further questions or information that you might need. Thanks, Bert Consultant for Helm c/o Ceres International LLC 1087 Heartsease Drive West Chester, PA 19382 phone 610-793-3222 fax 610-793-1708 bertvolger@comcast.net -----Original Message----- From: Johnson.Hope@epamail.epa.gov [mailto:Johnson.Hope@epamail.epa.gov] Sent: Tuesday, January 13, 2009 1:36 PM To: bertvolger@comcast.net Cc: mwixson@helmagro.com Subject: 74530-GT data matrix revisions Mr. Volger and Mr. Wixson, We are nearing completion of this action, however, I found additional issues with the data matrix that need to be corrected, and I apologize for the late hour. However, please revise the data matrix and send me a revised version as soon as possible. Revise the company number from 10102 to 10182 for Syngenta Crop Protection in your list of Data Submitters Revise "own" status to "pay" status for the Guidelines: Enforcement Analytical Method, Melting Point, Vapor Pressure, Dissociation Constant and Octanol/water partition Coefficient, as the submitter is Syngenta and not yourself. Thank you, Hope A. Johnson U.S. Environmental Protection Agency Office of Pesticide Programs Registration Division Herbicide Branch phone: 703-305-5410 

### Mail Code 7505P

"Bert Volger" <bertvolger@comc 

# Iast.net> 01/06/2009 05:24 PM To Hope Johnson/DC/USEPA/US@EPA cc <mwixson@helmagro.com>
Please respond to <bertvolger@comc ast.net> Subject RE: 74530-GT required label revisions and data matrix revisions

Dear Ms. Johnson, In response to your recent e-mail regarding your specific labeling and data matrix comments, we would like to provide you with the revised label (attached as pdf-file)and EPA Form 8570-35 (Agency and Public Copy, attached as pdf-files)

. please let me know, if you have any further questions or need additional information. We appreciate your timely review of the subject application. Sincerely, Bert Volger Consultant for Helm Agro US, Inc. c/o Ceres International LLC 1087 Heartsease Drive West Chester, PA 19382 phone 610-793-3222 fax 610-793-1708 bertvolger@comcast.net

-- -Original Message-- From: Johnson.Hope@epamail.epa.gov [mailto:Johnson.Hope@epamail.epa.gov) Sent: Tuesday, January 06, 2009 11:56 AM To: bertvolger@comcast.net; mwixson@helmagro.com Subject: 74530-GT required label revisions and data matrix revisions
Mr. Volger, Mr. wixson, The following label revisions are required to the pending label for 74530-GT. Please email me a revised PDF version of the label incorporating the following comments as soon as possible. I am still awaiting the review from TRB on your recently submitted data: Revise the color of the word POISON to RED on pages 1 and 2. Add the skull and crossbones symbol near the word POISON on page 2. Revise the order of the FIRST AID Statements to: 1) If Swallowed, 2) If In Eyes, 3) If Inhaled, 4) If on skin or clothingRevise the first paragraph of the precautionary Statements text to the following: "May be fatal if swallowed. Corrosive. Causes irreversible eye damage. Fatal if inhaled. Do not breathe spray mist or inhale contaminated dust. Do not get in eyes or on clothing. Harmful if absorbed through skin. Avoid contact with skin. Wear goggles, face shield or safety glasses. Prolonged or frequently repeated skin contact may causes allergic reactions in some individuals. Wash thoroughly with soap and water after handling and before eating, drinking, chewing gum, or using tobacco." Revise "waterproof gloves, waterproof footwear" on page 3 to "chemical-resistant gloves, chemical-resistant footwear" Remove "oats" from page 4 under Terrestrial Food + Feed Crop section. Remove "or clean of equipment" from the statement "Do not contaminate water, food, or feed by storage, disposal, or cleaning of equipment." On page 5, revise "should" to "must" in the statement "The Directions For Use of this product should be followed carefully" On page 5, add "To the extent consistent with applicable law before the following statements: 1) All such risks shall be assumed by Buyer and User
..... . 2) HELM MAKES NO WARRANTIES OF MERCHANTABILITy

.... . 3) In no event shall Helm or Seller be liable for

........ . 4) THE EXCLUSIVE REMEDY OF THE USER OR BUYER
............. . Also, please revise your data matrix to add Company numbers to the members of the PDSL that you are citing on pages 3 and 4. Please note that Syngenta Crop Protection Inc has 2 separate company numbers and needs to have 2 separate listings, and you are missing Sinon Corporation. Please resubmit the revised data matrix as soon as possible. Thank you, Hope A. Johnson U.S. Environmental Protection Agency Office of Pesticide Programs Registration Division Herbicide Branch Phone: 703-305-5410 Mail Code 7505P [attachment "Label Paraquat TC revised per EPA's comments 010609.pdf" deleted by Hope Johnson!DC!USEPA!US] [attachment "Paraquat dichloride EPA Data Matrix Form 8570-35 Agency Copy 010609.pdf" deleted by Hope Johnson!DC!USEPA!US] [attachment "Paraquat dichloride EPA Data Matrix Form 8570-35 Public Copy 010609.pdf" deleted by Hope Johnson!DC!USEPA!US]

090113 Paraquat TC EPA Data Matri:>< EPA form 8570·35 revised Agency copy.pdf

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### EPAFile Symbol Number74530-GT:
NOTETOFILE; TRB has not concludedthatthis productis substantially similarto 70552-1, as the Registrant has statedinpriordocuments. TRB concluded itcouldnotbesubstantially similarbecausethe nominal concentration ofthe active ingredientintheproposed productis lowerthanthelowercertifiedlimit ofthe citedproduct. However, all data requirements for product chemistry, except for storage stability and corrosion characteristicshavebeenmet, andthe acute toxicology datahas beenreviewed and accepted. Therefore, the generic datafor paraquat dichloride canbecited, and the Registranthas submitted a datamatrix withappropriate citations to the PesticideData Submitters Listto payfor the generic data. Therefore, HB will conditionallyregisterthis productper Section 3(c)7(a) ofFIFRA, as approvingthis application wouldnot significantly increasetherisk ofanyumeasonable adverse effect ontheenvironment.
1113/2009 

### HopeJohnson PMTeam25 Herbicide BranchHope Johnson/DCIUSEPNUS

.. 01113/200901:35 PM

Mr. Volger and Mr. Wixson, To <bertvolger@comcast.net> cc mwixson@helmagro.com bcc 

# \

Subject 74530-GT data matrix**revisions~**

We are nearing completion ofthis action, however, Ifound additional issues with the data matrixthat need to be corrected, and I apologizefor the late hour. However, please revise the data matrix and send me a revised version as soon as possible. Revise the company number from 10102to 10182for Syngenta Crop Protection in your list of Data Submitters Revise "own" statusto "pay" statusforthe Guidelines: Enforcement Analytical Method, Melting Point, Vapor Pressure, Dissociation Constant and OctanollWater Partition Coefficient, asthe submitter is Syngenta and not yourself. Thankyou, Hope A. Johnson U.S. Environmental Protection Agency Office of Pesticide Programs Registration Division Herbicide Branch Phone: 703-305-5410 Mail Code 7505P "Bert Volger" <bertvolger@comcast.net>
"BertVolger" <bertvolger@comcast.net> 01/06/200905:24 PM Please respond to <bertvolger@comcast.net>

Dear Ms. Johnson, To Hope Johnson/DC/USEPNUS@EPA cc <mwixson@helmagro.com> Subject RE: 74530-GT required label revisions and data matrix revisions

In response to your recent e-mail regarding your specific labeling and data matrix comments, w.e would like to provide you with the revised label (attached as pdf-file)and EPA Form 8570-35 {Agency and Public Copy, attached as pdf-files}. Please let me know, if you have any further questions or need additional information_ We appreciate your timely review of the subject application. Sincerely, Bert Volger Consultant for Helm Agro US, Inc. c/o Ceres International LLC 1087 Heartsease Drive West Chester, PA 19382phone 610-793-3222 fax 610-793 1708 bertvolger@comcast.net -----Original Message-- From: Johnson.Hope@epamail.epa.gov [mailto:Johnson.Hope@epamail.epa.gov] Sent: Tuesday, January 06, 2009 11:56 AM To: bertvolger@comcast.neti mwixson@helmagro.com Subject: 74530-GT required label revisions and data matrix revisions
Mr. Volger, Mr. Wixson, The following label revisions are required to the pending label for 74530-GT. Please email me a revised PDF version of the label incorporating the following comments as soon as possible. I am still awaiting the review from TRB on your recently submitted data: Revise the color of the word POISON to RED on pages 1 and 2. Add the skull and crossbones symbol near the word POISON on page 2. Revise the order of the FIRST AID Statements to: 1) If Swallowed, 2) If In Eyes, 3) If Inhaled, 4) If on skin or clothing Revise the first paragraph of the Precautionary Statements text to the following: "May be fatal if swallowed. Corrosive. Causes irreversible eye damage. Fatal if inhaled. Do not breathe spray mist or inhale contaminated dust. Do not get in eyes or on clothing. Harmful if absorbed through skin. Avoid contact with skin. Wear goggles, face shield or safety glasses. Prolonged or frequently repeated skin contact may causes allergic reactions in some individuals. Wash thoroughly with soap and water after handling and before eating, drinking, chewing gum, or using tobacco." Revise "waterproof gloves, waterproof footwear" on page 3 to "chemical-resistant gloves, chemical-resistant footwear" Remove "oats" from page 4 under Terrestrial Food + Feed Crop section. Remove "or clean of equipment" from the statement "Do not contaminate water, food, or feed by storage, disposal, or cleaning of equipment." On page 5, revise "should" to "must" in the statement "The Directions For Use of this product should be followed carefully" On page 5, add "To the extent consistent with applicable law before the following statements: i) All such risks shall be assumed by Buyer and User
..... . 2) HELM MAKES NO WARRANTIES OF MERCHANTABILITy

.... . 3) In no event shall Helm or Seller be liable for

... ..... . 4) THE EXCLUSIVE REMEDY OF THE USER OR BUYER. "

...'

....... . Also, please revise your data matrix to add Company numbers to the members of the PDSL that you are citing on pages 3 and 4. please note that Syngenta Crop Protection Inc has 2 separate company numbers and needs to have 2 separate listings, and you are missing Sinon Corporation. Please resubmit the revised data matrix as soon as possible. Thank you, Hope A. Johnson U.S. Environmental Protection Agency Office of Pesticide Programs Registration Division Herbicide BranchPhone: 703-305-5410 

### Mail Code 7505P [attachment "Label Paraquat TC revised per EPA's comments 010609.pdf" deleted by Hope Johnson/DC/USEPA/US] [attachment "Paraquat dichloride EPA Data Matrix Form 8570-35 Agency Copy 010609.pdf" deleted by Hope Johnson/DC/USEPA/US] [attachment "Paraquat dichloride EPA Data Matrix Form 8570-35 Public Copy 010609.pdf' deleted by Hope JohnsonlDC/USEPAlUS]

### DATE OUT: 01/09/09 

### SUBJECT: FEE PRODUCT CHEMISTRYREVIEW OF MP [ ] DP

### BARCODENo.: D359512 

### REG. No.lFile SymbolNo. 74530-GT 

### PRODUCT NAME: PARAQUATTC 

### PCC: 061601 

### Decision No. 393061 

### FOODUSE [X] 

### COMPANY: HELMAGRO US, INC.



### FROM: 

# .**0~d\**

# r~ "o\.'\

## \~ 0\\ 

### lndi Gairola, Chemist Ptbduct Chemistry Team Technical ReviewBranchIRD (7505P) 

### TO: James Tompkins /Hope Johnson PM25 Herbicide BranchIRD (7505P)



### INTRODUCTION: EP [X]

In

### response tothe Agency letter dated 10/28/08 

### HELM AGRO US, INC. has submitted details regardingthe unidentified impurities inthe subjectPARAQUAT TC. The submittedpackage was reviewed and details willbe discussedbelow:



### SUMMARY OFFINDINGS:

1. Applicanthas submitted informationregardingtoxicological significance of unidentifiedimpurities. 2. Applicanthas satisfiedrequirements of40 CFR§158.320 (c) and (d). Fordetails please refertothe CONFIDENTIALAPPENDIX.

### CONCLUSIONS:

1. 

### TRB hasreviewed for thesubmitted details regardingtheunidentified impurities in the subjectPARAQUATTC and has concluded that the identifiedimpurities are ofnontoxicological concern. 2 Applicanthas satisfiedrequirements of40 CFR§158.320 (c) and (d Please referto the Confidential Appendix for details

### EPA Registration File #75430-37 Page is not included in this copy. Pages 24 through 26 are not included in this copy. The material not included contains the following type of information: 

### Identity of product inert ingredients. Identity of product impurities. 

## x Description of product manufacturing process. Description quality control procedures. Identity of source of product ingredients. Sales or other commercial/financial information. A draft product label. The product confidential statement of formula.

Information about a pending registration action. FIFRA registrat data. The document a duplicate of page(s) The document not responsive to the request. Internal de information.

-------

### Attorney-Client work product. Claimed Confident by submitter upon submission to the Agency. Personal Privacy Information The information not luded is generally considered confident by product registrants. you have any questions, contact the individual who prepared the response to your request...Bert Volger" <bertvolger@eomcast.net> 01/06/200905:24 PM Please respond to <bertvolger@eomeast.net>

Dear Ms. Johnson, To Hope Johnson/DC/USEPA/US@EPA ee <mwixson@helmagro.eom> bee Subject RE: 74530-GT required label revisions and data matrix revisions

In response to your recent e-mail regarding your specific labeling and data matrix comments, we would like to provide you with the revised label (attached as pdf-file}and EPA Form 8570-35 (Agency and Public Copy, attached as pdf-files)

. Please let me know, if you have any further questions or need additional information. We appreciate your timely review of the subject application. Sincerely, Bert Volger Consultant for Helm Agro US, Inc. c/o Ceres International LLC 1087 Heartsease Drive West Chester, PA 19382 phone 610-793 3222 fax 610-793-1708 bertvolger@comcast.net

- ---Original Message---- From: Johnson.Hope@epamail.epa.gov [mailto:Johnson.Hope@epamail.epa.gov] Sent: Tuesday, January 06, 2009 11:56 AM To: bertvolger@comcast.neti mwixson@helmagro.com Subject: 74530-GT required label revisions and data matrix revisions
Mr. Volger, Mr. Wixson, The following label revisions are required to the pending label for 74530-GT. Please email me a revised PDF version of the label incorporating the following comments as soon as possible. I am still awaiting the review from TRB on your recently submitted data: Revise the color of the word POISON to RED on pages 1 and 2. Add the skull and crossbones symbol near the word POISON· on page 2. Revise the order of the FIRST AID Statements to: 1) If Swallowed, 2} If In Eyes, 3} If Inhaled, 4) If on skin or clothing Revise the first paragraph of the Precautionary Statements text to the following: "May be fatal if swallowed. Corrosive. Causes irreversible eye damage. Fatal if inhaled. Do not breathe spray mist or inhale contaminated dust. Do not get in eyes or on clothing. Harmful if absorbed through skin. Avoid contact with skin. Wear goggles, face shield or safety glasses. Prolonged or frequently repeated skin contact may causes allergic reactions in some individuals. Wash thoroughly with soap and water after handling and before eating, drinking, chewing gum, or using tobacco." Revise "waterproof gloves, waterproof footwear" on page 3 to "chemical-resistant gloves, chemical-resistant footwear"Remove "oats" from page 4 under Terrestrial Food + Feed Crop section. Remove "or clean of equipment" from the statement "Do not contaminate water, food, or feed by storage, disposal, or cleaning of equipment." On page 5, revise "should" to "must" in the statement "The Directions For Use of this product should be followed carefully" On page 5, add "To the extent consistent with applicable law before the following statements: 1) All such risks shall be assumed by Buyer and User
..... . 2) HELM MAKES NO WARRANTIES OF MERCHANTABILITy

.... . 3) In no event shall Helm or Seller be liable for

........ . 4) THE EXCLUSIVE REMEDY OF THE USER OR BUyER
............. . Also, please revise your data matrix to add Company numbers to the members of the PDSL that you are citing on pages 3 and 4. please note that Syngenta Crop Protection Inc has 2 separate company numbers and needs to have 2 separate listings, and you are missing Sinon Corporation. Please resubmit the revised data matrix as soon as possible

.. Thank you, Hope A. Johnson U.S. Environmental Protection Agency Office of Pesticide Programs Registration Division Herbicide Branch Phone: 703-305-5410 Mail Code 7505P

Label Paraquat TC revised per EPA's comments 01 OG09.pdf Paraquat dichloride EPA Data M I 8570·35Agency Copy 010G09.pdf Paraquat dichloride EPA Data Matrix Form 8570·35 Public Copy 010G09.pdfUNITEOSTATE$

### ENVtRONMENTAL PROTECTfON AGENCY 401 MStreet, 

### S.W. WASHINGTON, D.C. 20460
,,"

__ ".-i»'**,;.,.~~,~~~.**___**~_,..,,-,--_.** __**~~'...r""""w;~~»''''''''''_'~' _~~** __ ..**_,w;..~**___**~:.,_~""_"",~~""""",-,,,,,,_. ----,,.,,"""'---~** **Pa~f..Re(;\uQtjorl.Ac~** tesprmsef9r Pthi'!ftisP13d A**~**.....**-~-** .. - •..- ... 

# IDate:: Otj0610$

.**,~----,-'-.,--""""",~~~,**...**_;.<W~**__ '",¥,-..",.;.,';"**,;,.;...------.,..,--'--~,.,""'~,** 

### OATAIlltATRIX EPA 

### OJ ParaquaiTC

....::.:.: ' ,.....;...:C-,.....;."---"-"'--'

__-'

_____**~.-** ..,,-,--. -.

-----.,,---""'-c--"'--....;..-'--. MRIDNtlttlt;et ;Submitter 

### us. Inc.

# :~;~9~-+"~~m~--j.~~~~~=1.0wll Own**~-** ...- ..-","'.,-------"-1

.oWn



## -**C~rtff~Uini\s** NJA ,4.....,.,,··"-.,.;.4- -I

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.__**~~-,-.....".~~,,",',c-.' "4-'-,-'~""""""'-"'''"----~-**  Own**Ag~(Jcy** In1emalUsa.UNtTEDST.ATES ENViRONMENTAL PROTECTION AGENCY 401M$treet, S.W, WASHINGTON, 

### DyC, 26460**""~**..**~- ~** **~";';'--"'~'-** ..**-~~--"--.-..... -~-,** 

### ..**--.,,~-.~** .......,,-,'"----"-**."""''''''--.,;....~~=-,**

# '-=::::::~~~::~~~AJ~~~i=~~~I:!r:):~:~:li:'~'~~I:I:g:l:n:;:;n~N:~~i~:n:f~'~13~~~~~::::~::~ OilOslG}l

## ~ DAtA

### MATRIX

# ==~~~I~""S~;~;~~;;~'--"~~~-~==~=

. T-'**'-,-.....,.»»~.....** . S**-~'~Nw~.'''_· -.~**  ..**~. '~'-'-"'-"-'=-~l'** < .**"',.~"''''**....**~-.**-'----""'i Number 

### I. Submitter 

# r**S!atu~**
leal**I~""M' ~** ,,:,_-':-'**~I** .. I"

47:389104**4~t3a$i'Q4**lJNJft:OSiATES ENVIRONMENTAL 

### PROTECTION AGENCY 401 MStreat,S.W. WASHINGTON,O.C,20460



### . tfATAMA!RlX. 

### . r**'~~i'.",";** ..**,~_,--,,"-~~,--=-** Pmduc{; OOneSI'>ClflSO,

.**_,--~",-,-c' _".~** ••**',-~"._<,-",<M."' ··~-;""··.;";';"'·-·=-'·T-'-'·"""'-~-"r'**  

# ._-......,...,.,...--,...----_.•.**G~(d~ll!1a**ShJdy**Nam~** MRIDNumoor •Si,lbmitter . Status Nole 47001. Pl.)y 47691ttl8**""""-,,----~.---. ~'01<>""'.';** UNITED STATES E:NVlflONMENTAL PROTECTION AGENCY 401 MStrest,S. 

### W, WASHINGTON, 2046{)**:';"'''?'"'''~,,*~_.**_. _'_.

__**',~.»~., ~~**  __

.**_~:**__ "";".**~** ......**_~.~~w,_,_.,....-,-c..;,..,...;;"-...;.;.**__**~~** 

### DATA MATRIX

""'.";>",'.<;1 310**Paraqwa~ di~t\lbride**  Status N91e

,....**6:~ TasK:jZo~,**  L**,,~' '~~-~'"""""~** **"--~.~~;;-~** .J ,1**.~ :ce-~"",-~'-F"+:"--"-'**  .J 

### 1+ 1" 'I:**',~.:~ ~~~4** **,~..** 'I ",,-'-,.. '·1

Inc.Form Approved OMB No. 2070-0060**,~\** UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

### \.~ 401 M Street, S.W.**~ll'RJ'.ff'~** 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 and 0.25 hours per response for reregistration and special review activities, including time for reading the instructions and completing the necessary forms. Send comments regarding burden estimate or any other aspect ofthis collection of information, including suggestions for reducing the burden to: Director, OPPE Information Management Division (2137), U.S. Environmental Protection Agency, 401 M Street, S.w., Washington, DC 20460. Do not send the completed form to this address. Certification with Respectto Citation of Data Applicant's/ReQistranfs Name, Address, and Telephone Number EPA ReQistration Number/File Symbol Helm Agro US, Inc. 8295 Tournament Drive, Suite 310 Memphis, TN 38125 74530 - x Active Inqredient(s) and/or reoresentative test comoound(s) Date Paraquat dichloride April 30, 2008 General Use Pattern(s) (list all those claimed for this product usinQ 40 CFR Part 158) Product Name Terrestrial Non Food, and Terrestrial Nonfood use sites Paraquat TC NOTE: Ifyour product is a 100% repackaging ofanother 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 I: METHOD OF DATA SUPPORT (Check one method only) 

# 0 I am using the cite-all method ofsupport, and have included with this form 

# D I am using the selective method ofsupport (or cite-all option a list ofcompanies 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 ofdata requirements (the Data Matrix form must be used). SECTION II: GENERAL OFFER TO PAY [Required if using the cite-all method orwhen using the cite-all option underthe 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.

o '*' 

### , ,

## , > SECTION III: CERTIFICATION ) " 

### , ) ) ;; '} 3 1> I certify that this application for registration, this form for reregistration, or this Data-Call-In response is supported**b~** all datoi submitted or cited in the application for registration, the form for reregistration, or the Data-Call-In response. In addition, ifthe cite-all option or cite-all**Jliti~,i** illJder the selective method is indicated in Section I, this application is supported by all data in the Agency's files that (1) concern the properties or effects ofthi",**pro~uct** or an identical or substantially similar product, or one or more ofthe ingredients in this product; and (2) is a type ofdata that would be required to**be~sLbmitted** 11n1J'l)r**t~f7.** data requirements in effect on the date ofapproval ofthis application ifthe application sought the initial registration of a product of idil'lt;tal,or simila'r**cOI'n~osition** and uses. } 

### , , ) ;: ?, I certify that for each exclusive use study cited in support ofthis registration or reregistration, that I am the original data submitter oriha11.have obtained the written permission of the original data submitter to cite that study. ' •• , 3 

### , > I certify that for each study cited in support ofthis registration or reregistration that is not an exclusive use study, either: (a) I am the o,li!'lincll data submitter; (b) I have obtained the permission ofthe original data submitter to use the study in support ofthis application; (c) all periods of eligibility for compensation have expired for the 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)(1)(F) and/or 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 where an offer of compensation is required, copies of all offers to pay compensation and evidence of their delivery in accordance with sections 3(c)(1)(F) and/or 3(c)(2)(B) of FIFRA are available and will be submitted to the Agency upon request. Should Ifail to produce such evidence to the Agency upon request, I understand that the Agency may initiate action to deny, cancel orsuspend the registration ofmy product in conformity with FIFRA. I certify that the statements I have made on this form and all attachments to itare true, accurate, and complete. I acknowledge that any knowingly false or misleading statement may be punishable by fine or imprisonment or both under applicable law.**Signature~** Date Typed or Printed Name and Title April 30, 2008 Marshall Wixson, Manager Product Development EPA Form 8570-34 (9-97) ElectrOniC and Paper versions available. Submit only Paper version.\) '\ 

### ,

Hope JohnsonlDC/USEPAIUS To bertvolger@comcast.net, mwixson@helmagro.com cc

... 01/06/200911 :55 AM bcc Subject 74530-GT required label revisions and data matrix revisions
Mr. Volger, Mr. Wixson, The following label revisions are required to the pending label for74530-GT. Please email me a revised PDF version ofthe label incorporating the following comments as soon as possible. I am still awaiting the review from TRB on your recently submitted data:

- Revise the colorofthe word POISON to RED on pages 1 and 2.

- Add the skull and crossbones symbol nearthe word POISON on page2.

- Revise the order ofthe FIRSTAID Statementsto: 1) IfSwallowed, 2) If In Eyes, 3) If Inhaled, 4) Ifon skin orclothing

- Revise the first paragraph ofthe Precautionary Statements textto the following: "May be fatal ifswallowed. Corrosive. Causes irreversible eye damage. Fatal if inhaled. Do not breathe spray mist or inhale contaminated dust. Do not get in eyes oron clothing. Harmful if absorbed through skin. Avoid contact with skin. Wear goggles, face shield orsafety glasses. Prolonged orfrequently repeated skin contact may causes allergic reactions in some individuals. Wash thoroughly with soap and water after handling and before eating, drinking, chewing gum, or using tobacco."

- Revise "waterproofgloves, waterprooffootwear" on page 3 to "chemical-resistant gloves, chemical-resistantfootwear"

- Remove "oats" from page 4 underTerrestrial Food + Feed Crop section.

- Remove "or clean ofequipmenf' from the statement"Do not contaminate water, food, orfeed by storage, disposal, orcleaning ofequipment."

- On page 5, revise "should" to "must" in the statement "The Directions For Use ofthis productshould be followed carefully"

- On page 5, add "To the extent consistent with applicable law before the following statements: 1) All such risks shall be assumed by Buyer and User

...... 2) HELM MAKES NO WARRANTIES OF MERCHANTABILITY

..... 3) In no eventshall Helm orSeller be liable for

...... 4) THE EXCLUSIVE REMEDY OF THE USER OR BUYER.

...... Also, please revise your data matrixto add Company numbers to the members ofthe PDSL thatyou are citing on pages3 and 4. Please note that Syngenta Crop Protection Inc has2separate company numbers and needs to have 2 separate listings, and you are missing Sinon Corporation. Please resubmitthe revised data matrix assoon as possible. Thankyou, Hope A. Johnson U.S. Environmental Protection Agency Office of Pesticide Programs Registration Division Herbicide Branch Phone: 703-305-5410 Mail Code 7505P

## DATA PACKAGE BEAN SHEET Date: 09-Dec-2008 Page 1 of3 

### '" '"

.. Registration Information"''' 'I\' 

### Decision 

### #: 393061 DP 

### #: (359512) 

### PRIA Parent DP 

### #: Submission 

### #: 8401 Registration:**I1'~~l:fl~~~!J~**

### _______________ _**Company;~~~==~~~~~~**____________________________________ __ Risk Manager:**--~~~~~~~~~~~~~~~~~~~-------** Risk Manager Reviewer:**~~~--~~~~~------------------------** Sent Date:**~~'.:::.'.:~_** Edited Due Date: Type of Registration:**~~~~~~!!..:.:~~~ A~on~c:~~~~~~~~~~~~~~~~~~~~~~~~~~~~~** 

.. -I<

.. 

### Data Package Information" 

### '* '* Expedite: 

## 0 Yes. No Dale Sent:**~~~~:..-** Due Back: DP Ingredient: dichloride**-~~~~~~~~-----------------------------------**

CSF Included: • Yes 

### 0 No I...abellncluded: Yes. No Parent DP II:

______ _ 

## ---------

------

Organization:**~~~-----------** ______ Last Possible Science Due Date:**~~~~:..-** Team Name:



# ----------------- Science Due Date:

______ _ Reviewer Name:



# ------------------ Sub Data Package Due Date:

______ _ Contractor Name:



# -------------

... -I< 1r 

### Studies Sentfor Review"

...... Printed on Page 2

11

.... 

### Additional Data Package for this Decision"

... '" Printed on Page 3 

### '" "''' Data Package Instructions'"

### * 4< The registrant has submitted a**rA."lIYln~lA** tothe October21. 2008 PC review by Han Mukhoty. An additional PC review

### was oooducted previously dated October i, 2008. review new submission to seeif PC data requirements are now mel- Renegotiated PRIA date Is Jatluary 19. 2009.Page 2 DP#: (359512) • • • Studies Sent for Review' •• Decision#: (393061)Companv 10772

Compan 51311 

### Pesticide 

### By Active. Chemical Code

• Company Address

CHURCH & DWIGHT CO INC 469 NORTH HARRISON ST PRINCETQN,NJ 08543

t Company Address

HBC CHEMICAL INC.

220B QUINQUE LANE

llfTON,VA 20124
Companv • Company 66607 FORCE &. ALDRIDGE LLl? 

### Submitters List 30, 2001 Edition

Company • 748SS Company Address RESIDENTIAL EXPOSU 900 17TH STREET, WASHINGTON,DC 2 VENTURE (RE300

Company 

### t 81433

Company 83424 ress 1MS TRA NG, Ltc ST WILSHIRE BOULEVARD, f40 LOS GtLBS,CA 90036
Company Address OXFORD & HILL HOME PRODUCTS, LLC D/B/A OXFORD & HILL KOME PRODUCTS 1150 18TH ST, N.W., SUITE 1000 WASHINGTON,DC 20036

CHltMICAL CHEMICAL !IiANE 061601 Paraquat dichloride

Company /I lOO Company Address SYNGENTA CROP PROTECTION, ATTN: REGULATORY AFFAIRS PO BOX 1B300 GREENSBORO,Ne 27419
ComDanv Address THE SCOTTS COMPANY D/B/A THE ORTHO GROUP PO BOX 190 MARYSVILLE,OH 43040

### } Pesticide Data Submitters 

### By Active Chemical Code -Sep 30, 2001 Edition Company It Company Address 524 MONSANTO COMPANY 1300 I STREET, NW, SUITE 450 EAST WASHINGTON,DC 20005
Company # Company Address 1471 DOW ELANCO 9002 PURDUE RD

__**--~~~A~N~A~P~O~LI.S,IN** 46268
Comoany Ii 10182

CODiPany 1# 24630 Companv Address SYNGENTA CROP PROTECTION 410 SWING ROAD GREENSBORO,NC 27409
Company Address CRYSTAL CHEMICAL COMPANY 1525 N POST OAK ROAD HOUSTON,TX 77055
Company;; Company Address 66222 MAKHTESHIM-AGAN OF NORTH AMERICA INC 4515 FALLS OF NEUSE RD, SUITE 300 RALEIGH,NC 27609
Company 66607

Company 68292 1# Company Address SPRAY DRIFT TASK FORCE MCKENNA, LONG " ALDRIDG," 1900 K STREET, NW WASHINGTON,DC 20006 # COt1IPa.IlV Address

EDM INDUSTRIES INC. PO BOX 8552 I?ORTERVILLE,CA 93258 

# *Company Address

SINON CORP 1001 G ST., HW, SUITE WASHINGTON,DC 20001 LLP 

## .J



# --- Company II Company Address 71754 OUTDOOR RESIDENTIAL EXPOSURE TASK FORe 1350 I STREET, N.W. WASHINGTON,DC 20005

# ~ COlllPa.IlV # Company Address 

# / 71755 AGRICULTURAL REENTRY TASK FORCE 1350 I STREET, N.W. WASHINGTON/DC 20005**~any** " 73989

Companv # 74eSS

Company It 75234

Company # SlB7S

Com:panv II 82542

Compa.nv /I 82557

COtlipany 1# 83558

COlllPany 1# 84653 

### 'Pesticide Data Submitters Ust 

### Active Chemical 

### Code -Sep 30, 2001 

### Edition Company Address rlrRA ENDANGERED SPECIES TASK FORCE, L C/O HAROLD KIMMELMAN (BEVERIDGE :;/DI' ND, 1350 I STREET, NW WASHINGTON,DC 20005 Companv Addres s RO US, INC. NT DRIVE, SUITE 310

Companv Address RESIDENTIAL EXPOSURE JOINT VENTURE**~** 900 17TH STREET, NW, SUITE 300 WASHINGTON,DC 20006

company Addre$8 AGRICULTURAL HANDLERS EXPOSURE**TASK~** PO BOX 509 MACON,MO 63552
Com:pany Address 

# / GRIFFIN CORPORATION PO BOX 5126 VALDOSTA,GA 31603
Companv Address SOURCE DYNAMICS, LLC 10039 E. TROON NORTH DRIVE SCOTTSDALE,AZ 85262

COIII'P&nv Address SINON USA INC. 1001 G ST., NW, SUITE 500 WASHINGTON/DC 20001
Com:pany Address CELSIUS PROPERTY B.V., AMSTERDAM**(NL)~** NEUHAUSEN A.RHF BRANCH 4515 FALLS OF NEUSE RD., SUITE 300 RALEIGH,NC 27609 Company J\.d.d.ress GENERIC ENDANGERED SPECIES TASK FORCE '/ 500 EIGHTH STREET, NW WASHINGTON,DC 20004

CHEKICAL CSEldlCAL NAMlil 061602 1,l'-Dimethyl-4,4'-bipyridinium bis(methyl sulfate)

## ParaquatTC (Technical Concentrate) For Fonnulation ofParaquat Herbicide Products Only ACTIVE 

### INGREDIENT Paraquat dichloride (l,1**'~demethyl, 4J4'~bjpyridinium**  

### dichloride) 

### INERT INGREDIENTS 

### TOTAL Contains 3 pounds paraquat cation per gallon. Contains emetic. EPA Reg. No. 74530-xx EPA Establishment No.

### KEEPOU'~T~~~~~~J 

## POISON 43.8% 56.2% 100.0%

Si usted no entiende la etiqueta, busque a alguien para que se la explique a usted en detaJle, ([fyou do not understand the label, find someone to explain it 

### to you in detail).



### .. NEVER PUT INTO FOOD, DRINK OR OTHER CONTAINERS

.. IF SWALLOWED, TAKE IMMEDIATE ACTION AS PRESCRIBED IN FIRST AID STATEMENT.SYMPTOMS ARE PROLONGED AND PAINFUL.
Net 

### Contents:



### HELM AGRO Inc. 

### 8295 Tournament Drive Memphis, TN, 38125 info@helmagro.com

1 

### DRAFT submitted to EPA: 06-05-2008



# . , , ,

### Ifswallowed 

# ]I
Ifin eyes

Ifon skin or clothing

# \ItTfinhaled 

# I. FIRSTAID

... Speed is essential. Immediate attention is required. Ifavailable, Give an adsorbent such as activated charcoal, bentonite or Fuller's Earth.



### .. Call a poison control center or doctor immediately for treatment.

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

.. Hold eye open and rinse slowly and gently with water for 15 to 20 mins. Remove contact lenses, if

### present, after the first 5 minutes, then continue Tinsing eye.

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

.. Take offcontaminated clothing.

.. Rinse skin immediately with plenty ofwater for 15 to 20 minutes.

.. Call poison control center or doctor for treatment advice. • Move person to fresh air. • Ifperson is not breathing, call 911 or an ambulance. • Call a poison control center or doctor for further treatment advice. 

### NOTE TO PHYSICIAN Administer either activated charcoal (IOOg for adults or 2g1kg body weight in children) or Fuller's Earth (15% solution: 1 liter for adults or JSmglkg body weight in children. Note: The use of gastric lavage without administration of an adsorbent has not shown any clinical benefit. Do not use supplemental oxygen. Eye splashes from concentrated material should be treated by an eye specialist after initial treatment. With the possibility oflate onset corneal ulceration, it is advised that patients with paraquateye injuries are reviewed by an eye specialistthe day after first presentation. Use treatment that is appropriate for chemical bums. Intact skin is an effective barrier to paraquat, however contact with irritated or cut skin or repeated contact with intact skin may result in poisoning. Have the product container or label with you when calling a poison control center or doctor, or going for treatment. 

### HOTLINE For chemical 

# \J For medical emergencies involving this product, call CHETvITREC

### ~V Le_m_e_r..::;:g:..,.en_c..::.y_:_S.:...p_il:....I,_le_a_k_,_fi_re...:,,_e_x.:...p_os_u_f_e,:..,.o_r_a_c_c_id_e_n:..,.t,_c_a_II_C_H_E_M_T_R_E_C_l_-8_0_0_-_4_24_-,,9+-::::-::+

____ ----..!



## r .**~~** 

### e atal ifswallowed. Fatal if inhaled. Do not breathe spray mist. Do not inhale contaminated dust. 

## '--D'
- Causes sllbstantial**bl:lHewPQra~.** 

### Do not get in eyes or on clothing. Avoid contact with skin. Harmful 

### ifabsorbed through skin. Wear (goggles, face shieJd, orsafety glasses). IMPORTANT: 

### The effect ofswallowing paraquat concentrate is far more severe than that which usually Allu.ftresults 

### from skin contact or inhalation ofcontaminated plant dust. This product should not cause injury if CAI"-

### DIlsed according to label instructions... Dust/mist filtering NIOSH respirator with any R,P or HE filter • Protective clothing (disposable suit/coveralls or shirt and longpants)



### .. Full shield

.. (Category A) • Chemical resistant apron and shoes plus Wash 

### hands before 

### eating, drinking, chewing gum, lIsing 

### tobacco or the REMOVE contaminated 

### clothing and wash 

### from other laundry before 

### reuse. 

### ENVIRONMENTAL HAZARDS product is toxic to wildlife. 

### Do not discharge effluent 

### this product into 

### lakes, ponds, oceans, or public waters unless product is specifically identified and 

### addressed in a National Pollutant Discharge Elimination System (NPDES) permit. Do not contammg this product to sewer without previously the sewage treatment plant authority. For guidance, contact your Water Board or Regional of 

### PHYSICALAND CHEMICAL HAZARD This product reacts with aluminum to produce hydrogen gas which may a highly combustible gas 

### mixture. Do not mix or store in containers, 

### tanks, or such ofaluminum orhaving aluminum fittings. 

### EQUIPMENT/CONTAINER Flush all equipment with water use each day. Paraquat is 

### corrosive to 

### aluminum. Aluminum and structures that are to solution or 

### spillage should be flushed thoroughly with water immediately after use. 

### SPILLAGEDURING TRANSPORT Emergency Action: Notify police and departments immediately, For 

### any spill, 

### or exposure in the United States, call CHEMTREC 1-800-424-9300. 

### PUBLIC AND ANIMALS away 

### from area. MARK ROADS 

### AND WARN OTHER ROAD 

### USERS. WEAR shield, 

### V98tel"f3FGOfgloves, foorwear, and long-sleeve and long pants during deeontamination operations. 

# /"'01:---- .J (' '-"\.€ 

### V"-.-r L- .:::. l

# S up spills as soon as possible. Cover spill with generous amount of clay or loam soil to absorb liquid, using a broom to ensure contact. onto shovel and transfer to plastic or other disposable container. Repeat operations unt\l contaminated surfaces are 

### dry. Finally. hose spill site water, 

### iffeasible. 

### DIRECTIONS FOR USE It is a violation ofFederal Law to use this product in a manner inconsistent with its labeling.

3

### READ LABEL. STRICTLY IN ACCORDANCE WITH PRECAUTIONARY STATEMENTS AND DIRECTIONS, AND 

### WITH APPLICABLE STATE AND 

### FEDERAL REGULATIONS. Only for formulation into a herbicide for the following uses: 

### TERRESTRIAL FOOD CROP Acerola (West Indies cherry), banana, blackberry, blueberry, boysenberry, broccoli, carrot(including cauliflower, cherry, cocoa, coffee, collards, cucumber, eggplant, filbert (hazelnut), garlic, grollndcherry tomato/tomatillo), guava, hops, kiwifruit, lettuce, loquat, macadamia nut (bushnut), manioc (cassava), cantaloupe, musk, melons, olive, onion, papaya, pecan, pepino (melonpear), pepper, pineapple. pistachio, whitlIrish, prune, pumpkin, (black, rhubarb, small fruits, squash (all or unspecified), strawberry. sugar beet, walnut (Englishlhlack), yam, 

### TERRESTRIAL FOOD+FEED CROP Almond, apple, barley, beans, asparagus, beans, dried-type, mung; (lima); succulent (snap), fruits, com (unspecified), com, field, com, pop, com,

# ~ garbanzos (including chickpeas), grapes, guar, legume (unspecified), peanuts (unspecified), spearmint, sugar sugarcane, sunflower,tomato, turnip, vegetables (unspecified), wheat 

# (J,'

# ~.**~** r' TERRESTRIAL FEED CROP cotton (unspecified), mint,**~** orchards sugar crops,**~**

## J-I.. Alfalfa, barley, clover, crownvetch, legume vegetables, \espedeza, lupine,**~tUV-** V timothy, trefoil, vetch, 

### sainfoin,


### TERRESTRIAL**NON~FOOD** 

### CROP Agricultural fallow/idleland, fields, lawns, commercial/institutional/industrial, premises/equipment (outdoor), fencecrowslhedgerows, grasses grown for industrial areas (outdoor), jojoba, nonagricultural outdoor uncultivated areaS/soils, ornamental and/or shade trees, peach (non-bearing, beds), recreation area lawns, tomato wood protection treatment to products (seasoned). 

### FORESTRY Forest planting (reforestation programs), (forestlshelterbelt), shelterbelt plantings. 

### TERRESTRlALNON-FOOD Ornamental and/or shade trees, ornamental herbaceous plants, ornamental woody shrubs and vines, non* crop areas as public airports. stations and 

### OTHERS Uses which has accepted the required and/or citations of data that the formulator has submitted in support of registration; and uses for experimental are in compliance with 

### USEPA requirements,

4drinking water. Do not store next to feed or or in or on vehicles containing IVVI..I"C'Ui help with any leak, or exposure involving this call 9300. PESTICIDEDISPOSAL; wastes are acutely hazardous. Improper disposal ofexcess or is a violation ofFederal law. If these wastes cannot be disposed of by use to label instructions, contact your State or Environmental or the Hazardous Waste representative atthe nearest EPA for guidance. CONTAINER DISPOSAL: Triple rinse (or equivalent). Offer and of in a sanitary landfill, or dispose of by other
CONDiTIONS OF recycling or recondition, or puncture allowed by State and local

LIMITATION OF WARRANTY AND LIABILITY NOTICE: Read for Use and Limitation ofWarranty and retum the at once,
It is to eliminate all risks injury, ineffectiveness or other unintended consequences may result because such factors as manner of use or application, weather or crop conditions, presence of other materials or other influencing in the use the product, which are beyond the control Helm US, [nco or

### Seller~AII such shall assumed by Buyer and Buyer User to hold Helm and Seller harmless for any claims relating to such factors, Helm warrants that this product conforms to the chemical description on the label and is reasonably fit for the purposes in the Use, to the inherent to when used in accordance with directions under normal use conditions. This warranty does not extend to the use ofthis product contTary to instructions, or under abnormal conditions or under conditions not reasonably foreseeable to or beyond the control of or Helm, and and assume the risk ofany such

## use~LM MAKES NO WARRANTIES OF MERCHANT ABILITY OR OF FITNESS FOR A PARTICULAR PURPOSE NOR OrnER EXPRESS OR IMPLIED WARRANTY EXCEPT AS STATED ABOVE. • In no event shall or be liable for any incidental, consequential or resulting the use orhandling ofthis product.'nrn EXCLUSIVE REMEDY OF USER OR BUYER, AND THE LIABILITY OF HELM AND SELLER FOR ANY ALL CLAIMS, LOSSES, INJURIES OR DAMAGES (INCLUDING CLAIMS BASED ON BREACH OF WARRANTY) CONTRACT, NEGLIGENCE, TORT, STRICT LIABILITY OR OTHERWISE) RESULTING USE HANDLING 

### TIDS PRODUCT, BE RETURN THE PURCHASE PRICE OF PRODUCT A T ELECTION OF**ORSELLER~** REPLACEMENT OF PRODUCT. Helm and Seller offer this product, Buyer and accept it, subject to the conditions of sale 

### and limitations of and of liability, which may not be modified except by written agreement signed by a duly authorized Helm.



### 5

### ACTIVE INGREDIENT 

# ParaquatTC (Technical Concentrate) Formulation Paraquat Products Only
dichloride (I,I'-demethyl, 4,4'

### -bipyridinium dichloride)



### 3 pounds paraquatcation per Contains emetic.



# KEEP OUT OF REACH OF CHILDREN DANG 

# ELIGRO POlSON 43.8%
100.0%

Si usted no 

### entiende la etiqueta, busque a algulen para que se la explique a listed en 

### detalle. (If

### you do not
rI

..",,'<>nrl 

### the label, 

### find someone to it to you in 

### detail).



### .. NEVER PUT INTO FOOD, DRINK OROTHERCONTAINERS '" IF SWALLOWED, TAKE IMMEDIATE ACTION AS PRESCRIBED IN FIRST AID STATEMENT.SYMPTOMS AREPROLONGED AND Net



### HELM AGRO Inc. 8295 Tournament 

### Drive Memphis, TN, 381 info@helmagro.com 

### DRAFT 

### submitteO.J!l

1 " ' 

### 06-05 L

### 21)08

### FIRST AID Ifswallowed 

# .. Speed is essentia.l. Immediate attention is required. Ifavailable, Give an adsorbent such as a.ctivated charcoal, bentonite or Fuller's Earth.



# .. Call a poison control center or doctor immediately for treatment.



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

### Ifin eyes 

## • Hold eye open and rinse slowly and gently with water for 15 to 20 mins. Remove contact lenses. ifpresent, after the first 5 minutes, then continuerinsing eye. 

### '" Call a poison control centerordoctorfor treatment advice. Ifon skin or clothing 

### '" Take offcontaminated clothing. 

### '" Rinse skin immediately with plenty ofwater for 15 to 20 minutes. 

## • Call poison control centerordoctor for treatment advice. Ifinhaled 

## • Move person to fresh air. 

## • Ifperson is not breathing, call 911 or an ambulance. 

## • Call a poison control centerordoctor for further treatment advice. 

### NOTE TO PHYSICIAN Administer either activated charcoal (JOOg for adults or 2g/kg body weight in children) or Fuller's Earth (15% solution: 1 liter for adults or ISmg/kg body weight in children. Note: The use of gastric lavage without administration of an adsorbent has not shown any clinical benefit. Do not use supplemental oxygen. Eye splashes from concentrated material should be treated by an eye specialist after initial treatment. With the possibility oflate onset corneal ulceration, it is advised that patients with paraquat eye injuries are reviewed by an eye specialist the day after first presentation. Use treatment that is appropriate for chemical bums. Intact skin is an effective barrier to paraquat, however contact with irritated or cut skin or repeated contact with intact skin may result in poisoning. Have the product container or label with you when calling a poison control center or doctor, or going 

### 'c. 

### HOTLINE For medical emergencies involving this product, call CHEMTREC 1-800-424-9300. emergency: SpiII, leak, fire, exposure, or accident, call CHEMTREC 1-800-424-9300 

## PRECAUTIONARY 

## STATEMENTS HAZARDS TO HUMANS AND DOMESTICANIMALS DANGERJPELIGRO POISON For chemical



### May be fatal if swallowed. Fatal if inhaled. Do not breathe spray mist. Do not inhale contaminated dust. Causes substantial but temporary eye injury. Do not get in eyes or on clothing. Avoid contact with skin. Harmful 

### ifabsorbed through skin. Wear (goggles, face shield, or safety glasses). 

### IMPORTANT: The effect ofswallowing paraquat concentrate is far more severe than that which usually results from skin contact or inhalation ofcontaminated plant dust. This product should not cause injury if used according to label instructions. When handling or mixingconcentrate or when exposure to concentrate is possible, wear:

2III Dust/mist filtering NIOSH approved with any R,P or filter
III (disposable suit/coveralls or long-sleeve 

### shirt and long pants)

III Chemical-resistant gloves (Category
III Chemical resistant apron and shoes plus socks Wash hands drinking, gum, using tobacco or using the toilet. 

### REMOVE contaminated clothing and wash separately from other laundry reuse. 

### ENVIRONMENTAL HAZARDS This product is toxic to wildlife. not effluent containing this product Jakes, streams, ponds, estuaries, oceans, or public waters unless this product is specifically and addressed in a National Pollutant Elimination System (NPDES) permit. Do not discharge effluent containing this product to sewer without previously notifying the treatment authority. guidance, contact your Water Board or Regional Office ofEPA. 

### PHYSICAL AND CHEMICAL HAZARD This reacts with aluminum to produce hydrogen gas which may form a highly combustible gas mixture. Do not mix or store in containers, tanks, or such systems made ofaluminum or having aluminum fittings. 

### EQUIPMENT/CONTAINER Flush equipment 

### with water use each day. Paraquat is to aluminum. Aluminum equipment and aluminum structures are to solution or spillage should be flushed thoroughly with water immediately use. 

### SPILLAGE DURING 

### TRANSPORT Emergency Action: Notify police and fire departments immediately. For any spill, leak, fire, or exposure in the United call 1-800-424-9300. KEEP PUBLIC AND ANIMALS away from area. MARK ROADS AND WARN OTHER ROAD 

### USERS. WEAR shield, waterproofgloves, waterprooffootwear, 

### and shirt and long pants during decontamination Clean up spills as soon as Cover spill with generous amount of clay or loam soil to absorb liquid, a stiffbroom to ensure intimate contact. Sweep onto shovel and transfer to plastic bag or other disposable container. Repeat until contaminated are dry. Finally, spill site with water, iffeasible. 

### DIRECTIONS FOR USE It is a violation of to use this product in a manner inconsistent with its labeling.



### 3

### READ ENTIRE LABEL. USE STRICTLY IN ACCORDANCE WITH PRECAUTIONARY STATEMENTS AND 

### DIRECTIONS, AND WITH 

### APPLICABLE STATE AND 

### FEDERAL REGULATIONS. Only for formulation into a for thefollowing uses: 

### TERRESTRIALFOOD CROP Acerola cherry), asparagus, avocado, banana, blackberry, blueberry, boysenberry, broccoli, carrot (including tops), caUliflower, cocoa, collards, cucumber, eggplant.. fig, filbert (hazelnut), groundcherry (strawberry tomato/tomatillo), guava, hops, kiwifruit, lettuce, loquat, macadamia nut (bushnut), manioc (cassava), melons, melons, melons, musk. water, mint, nectarine, olive, onion, papaya, peach, pear, pecan, pepino (melonpear), pepper, pepper (chili type), pineapple, plum, potato, whit/Irish, prune, pumpkin, (black, red). rhubarb, small fruits, squash 

### (all or unspecified), strawberry, sugar beet, taro, walnut (English/black), yam, 

### TERRESTRIAL FOOD+FEED CROP Almond, apple, barley, asparagus, beans, dried-type, beans, mung; (lima); beanssucculent (snap), citrus corn (unspecified), com, field, corn, pop, corn, sweet, cotton (unspecified), garbanzos (including chickpeas), grapes, guar, hops, mint, oats, orchards (unspecified), peanuts (unspecified), edible, sugar beet, sugarcrops, sugarcane, sunflower, tomato, turnip, vegetables (unspecified), wheat. 

### TERRESTRIAL FEED CROP Alfalfa, barley, clover, crownvetch, legume vegetables, lespedeza, lupine, pastures, sainfoin, timothy, trefoil, tyfon, 

### vetch, wheat. 

### TERRESTRIALNON-FOOD CROP Agricultural fallow/idleland, airports/landing fields, commercial/industrial lawns, commerciallinstitutionallindustrial, premises/equipment (outdoor), fencecrowslhedgerows, grasses grown 

### for industrial areas (outdoor),jojoba, 

### Itural outdoor buildings/structures, nonagricultural uncultivated areas/soils, ornamental andlor shade peach (non-bearing, seed beds), recreation area lawns, tomato (post-harvest)/wood protection treatment to forest (seasoned). 

### FORESTRY Forest planting (reforestation programs), (forest/shelterbelt), plantings. 

### TERRESTRIAL NON-FOOD Ornamental and/or ornamental ornamental woody and vines, 110n

### crop areas such as public airports, electric transformer stations and around commeTcial buildings. 

### OTHERS Uses for which USEPA has submitted in support of USEPA requirements. the data and/or citations data that formulator has and uses for experimental purposes that are in compliance with

4drinking water. Do not store next to feed or food, or transport in or on vehicles containing foodstuffs or help with any spill, leak, orexposure involving this cal! 1-800-424- 9300. PESTICIDE DISPOSAL; Pesticide wastes are hazardous. Improper disposal excess u ...o,uv.ULor rinsate is a violation Federal law. If these wastes cannot disposed ofby lise according to label instructions, contact your Pesticide or Environmental Control Agency, or the Hazardous Waste representative at nearest Regional Office for guidance. CONTAINER DISPOSAL: Triple rinse (or equivalent). Offer for recycling or recondition, or puncture and dispose of in a landfill, or of by procedures allowed by State and local

CONDITIONS SALE AND LIMIT ATION OFWARRANTY AND LIABILITY NOTICE: Read the entire Directions for Use and Conditions of Sale and Limitation of Warranty and Liability before buying or usingthis product. Ifthe terms are not return the at once, unopened, the price will refunded. The Directions for Use ofthis product should be followed carefully. It is to eliminate all inherently associated with the use of this product. injury, or other unintended consequences may such as manner of use or application, weather or crop conditions, presence ofother materials or other influencing factors in the use ofthe product, which are the control ofHelm US, Inc. or Seller. All such shall be assumed by and and and User agreeto Helm and for any to such Helm warrants that this product conforms to the chemical description on the label and is reasonably 

### fit for thepurposes stated in for Use, to the inherent referred to when used in accordance with directions under normal use conditions. warranty not extend to the use ofthis product contrary to label instructions, or under abnormal or under conditions not reasonably foreseeable to or beyond the control ofSeller or Helm, and Buyer User assume the any such use. MAKES NO WARRANTIES OF MERCHANTABILITY OR OF FITNESS FOR A PARTICULAR PURPOSE NOR ANY OTHER EXPRESS OR IMPLIED WARRANTY EXCEPT STATED ABOVE. In no event Helm or be for any incidental, consequential or special resulting from the use or handling ofthis product. EXCLUSIVE REMEDY OF THE USER OR BUYER, AND EXCLUSIVE LIABILITY OF HELM AND SELLER FOR ANY AND ALL CLAIMS, LOSSRS+ INJURIES OR DAMAGES (INCLUDING CLAIMS BASED ON BREACH OF WARRANTY, CONTRACT, NEGLIGENCE, TORT, STRICT LIABILITY OTHERWISE) RESULTING FROM USE HANDLING OF PRODUCT, BE RETURN OF THE PURCHASE OF THE PRODUCT OR, AT THE ELECTION OF THE REPLACEMENT OF PRODUCT. Helm and product, and Buyer User it, to the conditions of and limitations ofwarranty and ofliability, which may not be modified except by written agreement by a duly authorized representative ofHelm.

5

# Memorandum Date: To: RegulatoryManager From: Infonnation Services Branch, ITRMD Yourreceipt ofthis data submission is not an indicationthatMRlDs for the enclosed studies have beenposted to OPPIN. 

# We expectthatitwill be approximately 5 days from the above datebefore the study-level datais available in OPPIN. you have any questions aboutthisprocess, please contactTeresaDowns (305-5363).

. 

# . IS 

# a: 

# W'fully accepted submission partially accepted submission 

# o rejected submissionUNITED ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D.C. 20460



### November 17, 2008

HELM AGRO US, INC. 8295 TOURNAMENT DRNE, SUITE 310 MEMPHIS, TN 38
Report ofAnalysis for CompliancewithPRNotice OfFICE OF PREVENTION, PESTICIDES AND TOXIC SUBSTANCES



### Thankyou for your submittal of17-NOV-08. Our staffhas completed a the materiaL The areprovided as follows: Your submittal was found to be full compliance withthe standards for submission of 

### datacontained in 

### PRNotice 86-5. A copy yourbibliographyis enclosed, 

### annotated with Master Record ID's (MRIDs) assigned to each document submitted. Pleaseuse numbers all future to these documents. Thankyou your Ifyou any questions concerningthis data submission, pleaseraise them the cognizantProduct Manager, to whom the datahaveApplication Date: Front End Date: FFS Due Date: " OPP Target Date:

### Fa~Tr8ck: 

# r 6-i;

### ~ 3.Nov.2008 J 

# fuJ]'**~ 7-N** **~~ 20** **08** "-' 

# l!rJ

# I 

# f " '" " 

# r '

. OPP Rec'vd Date:**~** , Risk Manager

## se nd

.Dat,e:

Receipt DeSt:ription: I •**r---~~~~-- --** **~~ --~------** **-- ----** **-- --** **---- '**  esponseto EPA product chemistry review

..... F orrn ;.1.; 

## r '· S lgntrtureDme:

## 'J r**---"- ""'-.~,..,..,.** **,!** I Ferrm 8: 

### I

",.

### 471878-00 

# HELm RO us, INC.. 8295 Tournament Drive, Suire 310 Memphis,Tennessee 38125 Phone: (901j312·1525 Fax: (901 J312·1535

Document Processing Desk (RD ) Office of Pesticide Programs (7504P) Environmental Protection Agency One Potomac Yard, Room 8-4900 S, Crystal Drive Arlington, VA 22202-4501 Attention: Ms. Hope 

### A Johnson Registration Division TC (EPA-Reg.No.74530
- Response to EPA's Product Chemistry Review, of information 

### Ms. Agro US Inc. herewith submits a response to your and 

### the Agency's Product Chemistry Review (Decision No. 393061). As indicated application is for the "me-too" registration of the active ingredient, as 

### a Manufacturing Use Product (MUP) in formulating registered End-Use Products. product is very similar in its composition and labeling to the existing product, Concentrate {EPA Reg. No. 82542-3}. The submitted document (see also attached bibliography of submitted studies) in more detail the issues raised in your letter (item #1) and within Review dated October 21,2008 (item #3 and 4) related to the toxicological the potential impurities. Concerning the outstanding data requirements (Ref.# stability. and #830.6320 -corrosion characteristics), are generated. As indicated in earlier e-mail correspondence, we understand that the review should be completed by January 19, 2009 (revised PRIA due date). do contact me at 610·793·3222 or Marshall Wixson at 901·312·1525, 

### if you have any or

cc: any additional information regarding this submission.

Wixson
- Helm Sincerely,

# ~~f-r~0- Bert Volger, Ph.D.

Consultant for HELM.Agro 

### US, Inc.1of 2


### BIBLIOGRAPHY OF SUBMITTED STUDIES Helm US, Inc. 8295 Drive,Suite310 

### Memphis, TN 38125 

### Product(s): Paraquat (Technical) 74S30-GT 

### Submission of data in response to EPA's Product Chemistry 

### Review (DecisionNo. 393061) October21,2008



### November 13, 2008 

### OPPTS EPAMRID Volume StudyTitle Laboratory, Guideline Number Number IDNumber Reference 

### (Reserved for EPA Number Use) loft 

### ParaquatTC HELM, N/A 

### 47617101 Helm Agro 

### Inc. #081110 Response to EPA's Product Chemistry 

### Review File SymbolNo. DP BarcodeNo. 357479; Decision No. 393061)

### Decision#: 393061 

### Fee Category: R310 

### Submittedby: Hope Johnson Company: HelmAgro Inc Recommendation ofDivision Directors NegotiatedDueDates Registration#: 74S30-GT PRIA Decision Branch: HB 

### 6 months

Original DueDate: 11119/2008 

### Proposed 

### New Due 111912009 

### PreviousNe onatedDueDates: 

### nJa the 

### "Fix" in-house? Yes received 11/17/2008 

### If

### not,date 

### "Fix" ex feted: Issue (describe in 

### detail): On October 28, 2008,

### theAgency sentthe Registrant a day deficiency letterstating product contains unidentified impurities, and data oftoxicological significance mustbe submitted. SummaryofDeficiencyType(s): NotSubmitted (N) 

### Deficiencies (D) 

### ProductChemiStry:

_ D _ 

### AcuteTox:

_ Efficacy:

__ Labeling:

__ Other (describe):

_ Describe Interactions with Company (describe when contactedand company'sresponseincluding response to previous negotiated duedates): The day deficiency letterwas senton October28, 2008. 

### The consultantfor theRegistrant, Bert Volger contactedHopeJohnson byphone November, andJimTompkins onNovember 12,2008. 

### Helater sentan email on 11/12/2008 

### to a 60 

### dayrenegotiation and stated they would be submittingadditionaldatalaterthatweek. TheAgency this new data on 11/17/2008 

### (front end. Yes No andreason for none? Rationalefor Proposed DueDate: TheTechnical Review Branchis 

### only missingtoxicological information on unidentified impuritiesother datahas beenreceived and reviewed. 60 

### days willbe adequatefor TRB to reassess this product's cbemistrywiththenew impurityinformation andto determine if

### all chemistrydata 

### re uirements have beenfulfilled.

If

### disapproved, action to be taken:
ODor

### Hi Jim, "BertVolger" <bertvolger@comcast.net> To Jim TompkinsJDC/USEPAlUS@EPA co Hope Johnson/DC/USEPAlUS@EPA, -Marshall Wixson" <mwixson@helmagro.com> 

### bee Subject Paraquat TC • File Symbol #74530-GT



### This e-mail is 

### inreferenceto the recent PCreviewregardingthe subject application for 

### a for Agro 

### US I 

### am presently the to a response providingyou withthe additional requested information related to thetoxicological signi

### ficance ofimpurities. Helmis planningto submitthis informationbytheend ofthis week. 

### In your coverletter dated October 28, 2008 to (MarshallWixson), it 

### was stated that the current PRIA date of 

### 11119/2008needs to be extendedinorderto review the additional data. In ourphoneconversation today, you mentionedthat a

### 60-dayreview is necessaryto complete this action. In ofthe upcoming season, Helm is keen to have this additional reviewprocess completedbymid 

### January 2009 (1119/09). We appreciate yourconsideration in this matter. Please let

### meknow about final PRIAdate, or ifyouhave any 

### further

BertVolger
Consultant for Helm Agro Inc. 

### elo Ceres International LLC 1087 Heartsease Drive West Chester, PA 19382 phone 610-793-3222 fax 610- 793-1708 bertvolger@comcast.net

# '- Or. WIXon, Hope JohnsonlDCIUSEPAlUS 1012812008 PM To "Marshall Wixson" <mwixson@helmagro.com> CC Jim TompkinsJDCIUSEPAlUS@EPA bee Subject 74530-GT 75 day deficiency tetter

",n",I"""O::'1'I below the letterfor EPA File Symbol 74530-GT. A hard copy is being mailed to you along with the reviews from the Review Branch. forward on to your consultant BertVolger ifyou wish. Thankyou. HopeA. Johnson 

### U.S. Environmental Protection Agency 

### Office of Pesticide Programs Registration Division Herbicide Branch Phone: 703-305·5410 Mail Code 7505P
scanpdl

-- Forwarded by Hope JohnsonJDC/U$EPAlUS on 101281200B 12:34 PM-**~Marshatl** Wixson" <mwixson@helmagro.com> To JohnsonIDC/uSEPAlUS@EPA 101271200812:19 PM CC '''Volker Heide'" <vheide@helmagro.com> Subject Helm's TC submission

Hope, I was very disappointed to hear om our regula10ry consultant, Bert Volger; that our Paraquat

## Te submission was being questioned f each listed below 0.1% on our I am notfamiliar with EPA requesting information in on anything listed below 0.1%. Is this a new trend intends to follow? If so, we need to adjust the waywe do our 5 batch. Is there for such a request? Thank you for your time. Regards, Dr. Marshall B. Wixson Manager Product Development Helm Agro US, Inc. 8295 Tournament Suite 310 MemphiS, TN 901/312-1525 901/312-1535 (Fax) 901/216-7530 (Cell)',,-,,'



# "- -Marshall Wix80n M <mwixson@helmagro.com> 10127/200812:19 PM To Hope JohnsonIDC/USEPAJUS@EPA cc "'Volker Heide"' <vl1eide@helmagro.com> bee Subject Helm's ParaquatTC submission
Hope, I was very to from our regulatory consultant, Bert Volger; that our Paraquat TC submission was being questioned les each listed below'0.1% on our CSF. I am not familiar woh EPA requesting information in t on anything listed below 0.1%. Is this a new trend EPA to follow? It so, we need to adjust the way we do our 5 batch. Is there precedence for such a request? Thank you tor your time. Regards, 

### Or. Marshall 

### B. Wixson Manager Product Development Helm Agro Inc. Tournament 

### Dr.. 310 Memphis. TN 38125 901/312-1 901/312-1535 (Fax) 901/216·7530 (Cell)UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D.C. 204(10



### (;C': 2 ;.:,**:j~~~** Dr. Marshall B. 

### Wixson Helm US, 

### Inc. 8295 

### Tournament Dr., Suite 310 Memphis, 

### TN 38125 Subject: EPA File SymbolNo. 74530-GT dated April 2008 OFFICE OF PREVENTlON,PESTICIOES AND TOXIC SUBSTANCES

The 

### application to abovehas determined, pursuantto 40CPR 152.105,

### not to be 

### SUIIlCl,enl:rj to process; therefore, the application 

### is considereddeficient Additional as specifiedbelow the the application can be completed. 

### Ifsuch deficiencies cannot r.l1fTPrIP,{I within 

### 75 days, you must notifythe 

### within those 

### 75 days 

### ofthe dateyou expect to completethe 75 you do not oryou fail to complete the application the scheduled times ofcompletion., theAgencywill terminate any action on the application, and will treat the application as 

### if

### it withdrawn by applicant. Any submission to 

### application must besubmittedas a new application. 1. productcannotbe determined "substantially similat"

### from theproduct chemistrypoint 

### of view to 

### the citedproduct 

### No. 70552-1 for 

### the following reasons: a. product contains Wlidentified impurities. 40 CFR 

### 158/320 (4)(0) and (d) requires you to submit data on toxicological of See attached Technical Review memos, 2. The following guideline data requirements are outstanding; a. Guidelines 830.63 year stability) and &30.6320 are outstanding. Itis understoodthat these are currentlyongoing,butplease note that these studies are still outstaJnding. Additional sciencereview 

### will berequired 

### ifyou resubmit any additional 

### data.. An additional four months ofreview time 

### will be once additional is submitted, and an extension current date of 

### 11/19/2008isrequired. Please contactHope Johnson as soon aspossible at 703-305- 5410 with an expected submittal date of required data listed above.



### Branch istrationDivision (7505P) Cc: Bert Consultant------:r. \J**~** .......: 

## \
--

: -...-;

L,'**~** 

## -t**~** 

# \3

d -.D



# I s;:.


## ,Y

' J) 

# o**~** 

## d 

## u**~** i DATE OUT: SUBJEC'f:

f ,

ROM:

TO: 

### ') ) ;

) 

# .**~."** 21 J OCTOBER I 2008 PRODUCT CHEMISTRY REVIEW OF MP

### fX') EP 

### f ) DP BARCODE No.: 357479 EPA Ftle Symbol No.: 74530-Gr PRODUCT NAME: Paraquat IC COMPANY: Helm Aqro US, Inc. FOOD US, £; ( X] ,INTEGRATED FORMULATION [X] PCC: 061601 Decision No. 393061 ACTION CODt=; R310 ' ftaoMokhoty \. \

# ~. Product Chemistry Team

# ~**~'"** Technical Review Branch / I ROo (1505P) Hope Johnson / James Tompkins, RM 2'5 Herbicide Branch / 

### RD (7505P)

, INTRODUCTION: This is in reference to product chemistry review for the proposed prodlJct submitted under EPA File Symbol 77453O-GT, Product

## name: 'ParaquatTC. The**p~odl:lct** chemistry data submitted were reviewed , on October 1, 2008'. TRB tlas been requested to re-evaluate the productchemistry data with respect

### to the information pertaining 

### to toxicological significance of impurities present in , the submitted CSF (dated 0610612008) for reg' istration ofthe aforesaid proposed product. SUMMARy OFFINDINGS AND**CONCLUS ONS:** 

. 1. The two impurities that will be discussed here are: (Unknown impur ities, each 0.1% w/w). nd Others

3. Discussion on presence ofother unknown impurities, each at 0.1 % w/w Jevel: With respect to these impurities the PM should request the registrant

### to clarify theirtoxicological significance, if any, at the level they are present in the product priorto the registration ofthe product

. 4

. The registrant did not submit the toxicological significance ofthe impurities present in the final

product. It is required under40 CFR 

### § 158.320 (4) (c) and (d)

.

1

### is not included 

### s Pages 61 through 62 are not luded in 

### s The not the following type of ion: Identi of ties. 

### x of product process. Description of ty procedures. ty of the source t 

### Sales or other 

# If ial A 

### product label. product idential statement about a trat FIFRA regi data. document is a of (s) 

### The to Internal del information.

----

### Attorney- work product. by tter upon Informat The not included who ion.

action.



### ss to the

conf
f 

### please contact request.

### UNITED STATES ENVIRONMENTALPROTECTION AGENCY WASHINGTON, D.C. 20460

14/0CT/2008


### MEMORANDUM Name ofPesticideProduct: 

### EPA File 

### Symbol: DP Barcode: DecisionNo,: Action Code: Paraquat 74530-GT 0353730 393061 

### R310 OF PREVENTION, nr-'''"..T,,..,T

......,.., 

### AND TOXIC

Cade: 061601 (paraquat dichloride) From:

Applicant: Eugenia 

### McAndrew, Biologist 

### Technical Review Branch Registration (7505P) Johnson, RMTeam 23 

### Branch Registration Division (7505P) Helm Agro US, Inc. 8295 TournamentDrive, Suite 310 

### Memphis,

### TN 38125


### FORMULATION FROM

......ru_'

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

### Paraquat dichloride 43.8
56,2 Total: 100.0% 

### ACTIONREQUESTED: The 74S30-GT. 

### Managerrequests

### review ofthe acute 

### toxicitydata

### BACKGROUND: Helm Agro US, Inc. has submitted a six pack acute toxicity studies to support theproposed product, Paraquat

## Te, File Symbol 74530-GT. Five ofthe studies were conducted at EurofinslProduct Safety Laboratories, Inc., Dayton, New The primary eye irritation study was conducted at Inveresk Research, Tranent Eh33 2NE, Scotland. MRID numbers are470911-07 to -11 and 46098805. A dated June 6, 2008 for a basic formulation is included in the submission. An 

### Agency contractor, OakRidgeNational Laboratory, conductedthe primaryreview ofthe studies. TRBperformedthe secondaryreview and changes as necessary,


### RECOMMENDATIONS: 1. The acute oral, acute dennal, acute inhalation, primary skin and dennal sensitization studies are classified as acceptable. Theprimary eye irritation studyis as unacceptablebecause the three animals tested had to bekilled onhumane grounds prior to the end ofthe study. The study author concludes that "Followingan ocularinstillation ofParaquat Technical, ithas been found to besystemically to rabbits

... Dueto the earlytermination ofthe study the results are inconclusive with regard to irritation." agrees with this conclusion and is assigningToxicityCategoryI for irritationbased on an examination oflabels ten currentlyregistered products containing 30.1 % 

### to 45.6%paraquat dichloride which are all in Category I orII for eye irritation. animal welfare reasons, is against any further testing ofthis product. 3. The acute toxicity profile for ParaquatTC, EPA File Symbol 74530-GT, is as follows: Acute oral toxicity II Acceptable MRID 47091107 Acute dermal toxicity Acceptable MRID 47091108 Acute inhalation toxicity I Acceptable MRID 47091109 Primary eye irritation 

### I Unacceptable MRID 46098805 skin irritation 

## IV Acceptable MRID 47091110 Dennal sensitization Positive Acceptable MRID 47091111


### LABELING: Based onthe toxicityprofile ab'ove, the following are the precautionary aid statements the proposedproduct as obtained from the Label System:

PRODUCT ID #: 074530-00037 PRODUCT NAME: Paraquat {Technical Concentrate}

2PRECAUnONARY STATEMENTS SIGNAL WORD: DANGER POISON 

### :l Hazards to Humans and DomesticAnimals: Restricted Use due to toxicity For to and use only by Certified Applicators or persons undertheir direct supervision and only for those uses covered by the Applicators certification. Fatal If Inhaled. Corrosive. causes irreversible eye damage. May be fatal ifswallowed. Harmful If 

### absorbed through skin. Do not spray mist. Do not get in eyes or on Avoid contact with skin. Prolonged or frequently skin contact may cause allergic reactions in some individuals. Remove and wash contaminated clothing before 

### reuse. Wear protective eyewear (goggles, 

### faoe shield, or safety glasses). Handlers mustwear a NIOSH approved respirator with any R, Por HE filter. Wash thoroughly with 

### soap and water after handling and before eating, drinking, chewing gum, or using tobacco. Wear long-sleeved shirt and long 

### pants, socics, and gloves. First Aid: 

### If inhaled: -Move the person to fresh air. 

### -If person is not breathing, call 

### 911 oran ambulance, then give artificial respiration, preferably mouth-tomouth if poSsible.**,~Call** 

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

open and rinse slowly and gently with water for 

### 15-20 minutes. contact if 5 minutes, then continue rinsing. a poison control center or for treatment advice. 

### Ifon skin; off contaminated clothing. -Rinse skin Immediately with plenty of waterfor 

### 15-20 minutes. 

### -Call 

### a poison control center or doctor fortreatment advice. 

### If swallowed: 

### a poison control center or doctor immediately treatment advice. -Have person sip 

### a glass ofwater If able to swallow. -Do not induce vomiting unless told to by a poison control center or doctor. ·Do not give anything by mouth to an unconscious person. NOTE TO PHYSIaAN: Probable mucosal damage may contraindicate the use of gastric lavage.

3h"

..**.,.tl,,~t** dichloride)
Note 

### to RMJRegistrant: The proposed label should contain a Note to Physician which addresses category 

### I Acute Inhalation Toxicity, Primary toxicity. The following statements 

### are 

### of Information may be Included, Ifapplicable:

- technical information on symptomatologYi • use ofsupportive treatments to maintain life functions; • medidne thatwitl counteract specific nm/SlCIllOO

- company telephone number to**"1-'~'''''''''''L'''l..I** medical advice. Have the product container or label with you when calling a poison control center or doctor or going for treatment. You may also contact 1-80Q·xxx-xxxx for emergency medical treatment information.

4

### DATA EVALUATIONRECORD PARAQUATDICHLORIDE (PARAQUAT 43.8% TECH) STUDY TYPE: ACUTE ORAL TOXICITY

- RAT [OPPTS 870.1100; OECD 425] ACUTEDERMALTOXICITY

- RAT [OPPTS 870.1200; OECD 402J ACUTEINHALATIONTOXICITY

- RAT [OPPTS 870.1300; OECD403] ACUTE IRRITATION

- RABBIT [OPPTS 870.2400; OECD 405] ACUTE DERMAL IRRITATION

- RABBIT [OPPTS 870.2500; OECD 404] DERMALSENSITIZATION

- GUINEA PIG [OPPTS 870.2600; OECD 406]**~D47091107,47091108,47091109,46098805,47091110,and47091111**



### Quality Assurance: Prepared for Registration Division Office ofPesticide Programs U.S. Environmental ProtectionAgency One Potomac Yard 

### 2777 South Crystal Drive

Arlington, V A 

### 22202

...rl""n"',.."'11 

### by Toxicology and Hazard Assessment Group Environmental Sciences Division

OakRidge National Laboratory 

### 1 Task OrderNo. 1-28

Date:

Date:

Date:

Disclaimer This review may have beenaltered subsequentto the contractor's Oak National Laboratory managed and operated by 

### DT-Battelle, 

### ofEnergy under Contract No. 

### DE-AC05-000R2272S. above. for the

# u.s. Department

### Reviewer:

___ --'==..l..!::::.

_______ _ 

### Date: July 

### 15,2008 Manager (EPA): 25
STUDYTYPE: Acute Oral Toxicity- Rat; OPPTS 

### 870.1100; OECD 

### 425 TESTMATERIAL: Paraquat

### 43.8% Tech 

### (-48% paraquat dichloride; 

### Lot No. notreported, PSLReferenceNo. 

### 061026-40; dark green liquid, pH 3.98 as a 1

### % w/w solution, gravity t

### .157 g/mL, soluble in water) 

### CITATION: Durando, J. 

### (2007) Paraquat 

### 43.8% Tech Acute Oral Toxicity Up and Down Procedure in Rats. StudyNumber

### 21077. EurofinslProduct SafetyLaboratories, 

### 2394US Highway 

### 130,**Dayto~** 

### NJ 

### 08810. March 

### 15,2007. MRID 

### 47091107. SPONSOR: SourceDynamics 10039 Troon North Drive, Scottsdale, AZ 

### 85262**~~~u...!.~~~~~.** 

### In an acute oral toxicity study (MRID 47091107), eight fasted, young adult female Sprague-Dawleyrats (age: 10-12 weeks; body weight: 185-230 Ace Animals, Inc., Boyertown, PA) were given a single dose ofParaquat 

### 43.8% Tech 

### (-48% paraquat dichloride; LotNo. notreported) as received. Based on the estimated LDso supplied by the Sponsor (550 mglkg), a Main Studywas conducted using a default starting dose 

### 174 mglkg which was administered t onefemale ratby oral gavage. Followingthe Up and Down procedure, seven additional animals were dosed at levels of 

### 174,550, or 

### 1750 mglkgbw and observed for 14 days. An animals dosed at 

### 174mglkg survived, gained weight, and were andhealthyduringthe study. 

### An animals dosed at

### 550 died within eight days dosing and the animal dosed at 1750mglkg died within one dayofdosing. Hypoactivity, reduced fecal vo]wne, feces, hunched posture, and/orpiloerection were noted from all 

### 550 mglkg decedents prior to death. 

### 1750 mglkg animal was hypoactiveprior to death. Discoloration of intestines andlor liver was noted from the decedents at necropsy. uu,'

......, .... 

### Females LDso

## =254 mglkgbw (Approximate 

### 95% confidence interval is 174 mglkg (lower) to 

### 550 (upper)mglkg.) 

### Paraquat43.8% Tech is in 

### EPAToxicityCategoryII. This study is classified as acceptable. It does satisfy the guidehne requirements for an acute oral study (OPPTS 870.1 100; OEeD 

### 425) in the rat.**.;::::..;;;=~=~=.** 

### Signedand dated GLP, Quality statements were provided.

6 

### Data Confidentiality

### RESULTS DISCUSSION: AOT425statpgm (Version: 1.0) TestResults and Recommendations Acute Oral Toxicity (OECDTest Guideline425) Statistical Program DatelTime: Tuesday, July 15,2008,2:29:45 

### PM Datafile name: 

### work.dat modified: 

### 7/1512008 

## PM Test/Substance: Paraquat43.8% 

### Main

(mglkg): 2000 

### LDso Default Assumed 0.5 Recommended dose 2000,550,175,55,17.5, DATA: Animal Dose Short-tenn Long-term 

### Seq. ID (mg/kg) Result Result 1 3101 174 2 3102 550 3 3103 1750 4 31 550 5 3105 174 6 3106 550 7 3107 174 8 3108 

# eX Died, 0 

## =Survived) 

### 0 0 X 

### X 0 0 X 

# o X


# o o

DoseRecommendation: main testis complete. Stoppingcriteria met: criterion.

7 

### 1

### SUMMARY OF LONG-TERM RESULTS: Dose 0 X 

### Total

174 3 0 3 0 

### 4 4 1750 0 1 1 

### All Doses 

### 3 5 

### 8

Statistical Estimatebased on long tenn outcomes: Estimated LDso

## =254 

### (Based on an 

### assumed sigma

### of0.5). 

### Approximate 95% confidenceinterval is 174

### to 550. 

### Animals were dosed as follows:



### AnimalNumber Sex

## ~ 3101 F 174 3102 

### F 550 3103 

### F 1750 3104 

### F 550 3105 

### F 174 3106 

### F 550 3107 

### F 174 3108 

### F 550 

### S = 

### Survival, D = 

### Death 

### Long-Term Outcome S D D D S D 

### S D



# ===..... AU animals dosed at 550

### mglkgdied within dosed at 1750 

### mglkgdied within one day

### Of

....V3UIJ;;. 

### days ofdosing and the animal**!:d!l!lli~Q!2li£!:rn!2!lll:** 

### Hypoactivity, reduced fecal volume, soft hunched posture, to death. 1750 

### and/orpiloerectionwere all 550 

### animal washypoactivepriorto death. AU 1 P'o

.... J"""" 

### weight and were active healthy

### during C. 

### No abnonnalitieswerenoted from any 1 

### Discoloration oftheintestines was noted 

### D. Deviations: Due to 

### a technician Animal Number 3107

## was weighed on 10 instead of 7.
8dichloride) 

### E. Thisrevieweragrees withthe study author regarding the acute oral

9

### Reviewer:

___ -...;::=..:..::::. _______ _ 

### Date: July 15,2008 

### RiskManager (EPA):

STUDYTYPE: AcuteDennalToxicity

- Rat; OPPTS 870.1200; OECD 402 TEST MATERIAL: Paraquat43.8%Tech (-48%paraquat dichloride; 

### LotNo. notreported, PSLReferenceNo. 061026-40; dark green liquid, pH 3.98 as a 1

### % 

### w/w solution, specific gravity 

### 1.157 g/mL, solubleinwater) CITATION: Lowe, (2007) Paraquat43.8%Tech

- Acute ToxicityinRats -Limit StudyNumber21078. EurofinslProduct SafetyLaboratories, 2394US Highway 130, Dayton. NJ 08810. February20,2007. MRID 47091108. Source Dynamics 10039 North Scottsdale, 85262 In an acute dermal toxicity study (MRID 47091108), five male rats 0 weeks; bodyweight: 307- 316 g and females: 209-218 source: AceAnimals, Inc., Boyertown, PA) were dermally exposed for 24hours on an area ofapproximately 10%ofthe total body area on clipped dorsal 

### trunkto 2000 mglkgbwParaquat43.8%Tech (-48%paraquatdichloride; LotNo. not reported; pH 3 as a 1

### % w/w solution) as testmaterial was applied evenly over the area andcoveredwith a pad. gauze the

### trunk werewrapped with Durapore tape. Theanimals were observed 

### for 14 days. All animals survived and weight duringthe study. Irregularrespiration wasnoted. from onemale and 

### three females onday 

### 1. All other appeared active and healthy throughout the study. Erythema and werenoted ontwo males and on 

### 1to 

### 4 

### or 1

........,...",,;.« 

### was noted on on days 

### 5to or No gross abnormalities were noted at
LD50 Males 

### > 2000mglkgbw LD50 

### > 2000 bw LD.so Combined. 

### > 2000 bw 

### Paraquat

### 43.8'Vo Tech is EPAToxicity CategoryHI. This is classified as acceptable. 

### Itdoes satisfy guideline lrernenrs for an acute dermal study (OPPTS 870.1200; OECD402)intherat. COMPLIANCE: Signed and dated GLP, QualityAssurance and DataConfidentiality statementswereprovided.

10

### RESULTS and DISCUSSION:

Mortality: All animals survived the study. B. Clinical observations: Irregularrespiration was noted from onemale and three females on day 1. All otheranimals appeared active and healthy throughout the study. Erythema and edemawerenoted ontwo males and four females on days 1

### to 4 

### or 1 . 

### Escharwas notedon four females on days 5 to 12 or5-14. All animals gained weightthroughout the study. C.**!:!!.2!I!~:£r!m!l:::** 

### No gross abnormalities were noted atnecropsy. D.**~~~~~~~l¥;I!ol!.'** 

### Thisreviewer agrees with the study author regarding the acute dermal 

### LDso.

11"''''''''''''1[ dichloride)


### Reviewer: ORNL Date: July 15,2008 RiskManager (EPA): 25
STUDYTYPE: Acute Inhalation Toxicity Rat; OPPTS 870.1300; DECD 403 Paraquat43.8% PSLReferenceNo. 061026-4G; dark water) (-48%paraquat dichloride; LotNo. not reported, liquid, pH 3.98 as 

### a 

### 1 %

### w/w solution, soluble in
Lowe, (2007) Paraquat .8% Tech Acute InhalationToxicity StudyinRats

- Limit Test. StudyNumber21079. EurofinsfProduct Safety Laboratories, 2394 US Highway 130, Dayton, NJ 08810. March 14,2007. MRlD 47091109. SPONSOR: Source Dynamics 10039 TroonNorth Drive, Scottsdale, AZ 85262 In an acuteinhalation toxicity study (MRID 47091109), five male and five female young adult Sprague-Dawleyrats (age:**9~10** 

### weeks; bodyweight: males: 297- g and females: source: Ace Animals, Boyertown, PA) were exposed noseonlyinhalation to Paraquat .8% (-48%paraquat dichloride; Lot No. notreported) for 4 hours and 1minute at a concentration of0.051 mglL. The were observed for 14 days. TheMMAD was 2.1 and 2.2 !lIn 

### and the GSD 2.14 and 2.02 at 1.5 and 3 hours, respectively. All males and four females died within 2-4 days following exposure and onefemale was emaciated and euthanized on day 7. All animals exhibited abnonnal respiration, hypoactivity, piloerection., andreduced fecal volume within one day ofexposure. All animals had discolored lungs, liver, and/or intestines; edematous**lungs~** 

### intestines distended with and/or at n ..'·

...."

...;;,'11 

### LC50 

### Males < 

### 0,051 mglL LCso

### Females < 

### 0.051 mglL Combined < 

### 0,051 mglL Paraquat

### 43.8% Techis in

### EPAToxicity CategoryI. This study is classified as acceptable, It

### does satisfythe guideline inhalation study (DPPTS 870.1300; DECD 403) in therat. for an acute
COMPLIANCE: Signed and dated GLP, QualityAssurance and Data Confidentiality statements were provided.

12

### RESULTS and DISCUSSION: Nominal

Cone. MMAD**~** 

### GSD 2.1,2.2 2.14,2.02 MortalltylNumberTested

Test

### Atmosphere/ Chamber Description: The exposure atmosphere was generated a 114 

### inch JeO 

### atomizer (Spraying Systems Co.), fluid cap (Robert Miller and 70 

### air cap (Spraying Systems The test was metered

### to the atomization through a pumpwith 

## a60 mLplastic airwas supplied by an 

### air compressor connected to the sprayatomizationnozzle. Additional compressedmixing air was suppliedfrom a compressed airtank. Animals were individuallyhoused in polycarbonate holding which were to chamberduring exposure. The exposure chamberwas a

### Mini Nose-Only Chamber (ADG Developments Ltd.).

Gravimetric Cone. (mg/L): 

### 0.051
I.,.

.. ! U.I 

### TotalAirflow (L/min): 

### 25.7 Temperature 21-23°C Relative Humidity Time to equilibrium: 1 minute
Test atmosphere concentration: exposure, samples were collected five from thebreathing zone ofthe animals, glass filters. papers were weighed before and collection to determine themass collected. Thevaluewas dividedby the total volume ofair sampled to determine the chamber concentration. Particle sizedetermination: Particle was determined twiceusingan eight-stageAndersen """",,",u,",,,,, 

### impactor. The test material concentration coHected 

### at was 

### aet:errrurle<1 gravimetrically. Themass median diameter geometric standard were determined graphicallyusingtwo-cycle logarithmicprobit axes. A. MortaliD:.': All males and four females died within 2-4 following exposure and one female was emaciated and euthanized onday 7 for humanereasons. B. All animals exhibited abnonnal respiration, facial staining, hypoactivity, piloerection, and reduced fecal volume within onedayofexposure. 13

### C. All animals had discolored**lungs~** 

### liver, and/or distended intestines with 

### and/or at necropsy. 

### This reviewer with the 

### study author 

### the acute

141l'lMl!IQuat dichloride)**Re~ewer:** 

### ______**~~~**

### ______________ _ Date: July 15,2008 

### RiskManager(EPA): 25**=~::;....:;......::....:~::::;.** 

### Primary

- Rabbit; OPPTS 870.2400; OECD 405**~~~~~~~.** 

### ParaquatTechnical (a 

### minimumof45%paraquat; BatchNo. OFE0016; green liquid, 

### pH -5.5) CITATION: (2002) ParaquatTechnica!- hritationTestinRabbits. Project Number 501218. Inveresk Research, Tranent Eh33 2NE, Scotland. February 

### 12, 2002. 

### MRID 46098805. SPONSOR: SourceDynamics LLC, 10039 TroonNorth Drive, Scottsdale, AZ 85262 

### EXECUTIVE SUMMARY: In a primary irritation study (MRID 46098805), 0.1 of undiluted ParaquatTechnical (aminimum of45%paraquat; Batch No. OFE0016; pH -5.5) was instilledinto the conjunctival sac ofthe right 

### eye ofthree young adult NewZealand White rabbits Charles River

### UKLimited, Marston Road, Margate, Kent). Theuntreated served as a controL Onerabbit was treated

### first and observedfor signs irritationfor 24 nonewere noted, the remaining two rabbits were treated. 

### The animals were observed hours. Corneal opacity and werenotnoted in anyrabbit eye duringthe study. Positive conjunctival irritation was noted 

### in eyes at 24 hours and in eyes at 72hours after test material instillation. to systemictoxicityincluding salivation, inappetence, andreddening ofgums, one animal was killedon day 6 (five days after testmaterial instillation) and two animals werekilled onday 

### 5 (four days aftertest material instillation). 

### In

### this study, theToxicityCategorycannotbe assigned due to earlytermination ofthe study. TRB is assigningToxicityCategoryI. is classified as unacceptable. 

### It not 

### satisfy guideline for 

### a

irritation study (OPPTS 870.2400; OECD405) 

### in

### the rabbit, butdueto extreme toxicityof

### the test material, 

### is assigning a ToxicityCategory 

### 1. The study shouldnot

### be repeated, Signed and dated statements wereprovided. QualityAssurance andData Confidentiality

15

### RESULTS and DISCUSSION: Number" ositive"lNumber treated Hours 

### 1 

## 24 48 

### 72 

### 0/3 0/3 0/3 0/3 0/3 

### 0/3 0/3 

### 0/3 0/3 

### 0/3 2/3 3/3 2/3 

### 0/3 0/3 0/3 

### 0/3 0/3 Dischar e** 0/3 0/3 3/3 

### 3/3 3/3 '" Scoreof2 ormorerequired to beconsidered "positive" 

# ** Discharge

### is not a positiveeffect according to the grading scale 

### A. Observations: Corneal opacity andiritis werenot noted inany rabbit eye duringthe study. Positive conjunctival irritation was noted in 2/3 eyes at 24 hours and in 3/3 eyes at72 hours 

### aftertest material instillation. Due to systemictoxicityincluding salivation, inappetence, and reddening 

### gums, one 

### animal was killed on

### day 6 (five 

### days aftertestmaterial instillation) and two animals werekilled on day5 (fourdays test material instillation). No corneal opacity, iritis, orconjunctival irritationwere noted 

### from the control 

### B. Results: highestmaximummean total score was 1**O.O~** 

### recorded 48 and 

### 72 hours after test material instillation (calculated 

### bythe reviewer). 

### C. study authorconcludesthat "Following

### an ocularinstillation 

### ofParaquatTechnical, 

### it 

### has been found to be systemically

### toxic to rabbits;

... Due 

### to early

### termination studythe are 

### inconclusivewith to 

### irritation." TRB agrees with this conclusion and is assigningToxicity I primaryeyeirritation 

### based on an examination ofthe

### labels oftencurrently 

### products containing 

### 30.1 % to 45.6% paraquatdichloride which are all 

### in lorII for irritation. For 

### animal welfarereasons} is against any further testing ofthisproduct.

16(plmlquatdichloride)


### Reviewer:**------~~~---------------** 

### Date: July 2008 

### RiskManager (EPA):


### STUDY TYPE: PrimaryDennal Irritation

- Rabbit; OPPTS 870.2500; 404 

### TESTMATERIAL: Paraquat 43.8% (-48%paraquat dichloride; 

### Lot No. notreported, PSL ReferenceNo. 061026-4G; dark 

### green liquid, pH 3.98 as 

### a 1 % w/w solution, specific gravity 1.157 glmL, soluble water) CITATION: Lowe, C. (2007) Paraquat 43.8% Tech

- Primary SkinIrritation StudyinRabbits. StudyNumber21081. Eurofins/Product SafetyLaboratories, 2394 US Highway 130, Dayton, NJ 08810. February20, 2007. MRID 47091110. 

### SPONSOR: Source Dynamics LLC, 10039 TroonNorth Drive, Scottsdale, AZ 85262 In 

### a primary dennal irritation study (MRlD 47091110), onemale young adultNew ZealandWhiterabbit (source: Robinson Services, Inc., Clemmons, NC) was dermally to 0.5 mL ofundiluted Paraquat43.8% (-48%paraquat dichloride; Lot No. not reported; pH 3.98 as a 1 % 

### w/w solution) for 3 1 hour, and 4 hours, respectively, on three 6 cm2 

### areas the clipped dorsal skin that were covered with patches. The patches and 

### trunk were wrapped with**semi~occlusive** 

### Micropore tape. The animal was observed and irritation was scored at 1, 24, 48, and 72 hours after patchremovaL Twoadditional rabbits were for four hours usingthe sameprocedure as the rabbit. Very slight erythema was noted on 3/3 rabbits 30-60minutes after patchremoval with clearance 72 hours. Very slightedema was noted on rabbits 30-60 minutes afterpatchremoval with with clearanceby24 hours. In 

### addition, the first animal tested "exhibited an unthrifty appearance, nasal discharge, yellowlbrown incolor and excessive salivation with no apparent abscess at hours." 

### Inthis study,theformulation was slightly irritatingbased on the

### Primary Irritation Index (PH) of 1.0. Paraquat43.8% Tech is in

### EPA Toxicity CategoryIVfor primarydermal irritation. This study is classified as acceptable. It

### does satisfythe guidelinerequirements a primary dermal irritation study (OPPTS 870.2500; OECD 404) intherabbit.**~~~~~~.** 

### Signed and dated statements wereprovided. Quality Assurance and Data Confidentiality

17tpantquat dichloride)


### RESULTS and DISCUSSION:
Animal Sex Hours Number 

### 1 

### 24 48 72 

### 3501 M' 

## lila 1/0 110 

### 0/0 3502 M 

## 111 110 110 

### 0/0 3503 M 

## 111 110 

### 1/0 010 Severity 

### ofIrritation 2.0 

## LO 1.0 0.0

- Mean Score
a 

### ErytItvloaiedem. 

### A. Observations: Very slight erythemawas noted on 3/3 

### rabbits (treated for 4 hours) 30-60 minutes patchremoval with clearanceby72 

### hours. Veryslight 

### edema was noted on 3/3 

### rabbits 30-60minutes afterpatchremoval with clearanceby24 hours. Thetest site on the rabbit for 3 minuteshad no dennal irritation. test site on the first rabbit for onehourhad slight erythema 30-60minutes after patchremoval with clearanceby

### 24 hours. In addition, the first animal tested "exhibited an unthrifty appearance, nasal discharge, yeIlowlbrownin and excessive salivation withno apparent abscess at hours." 

### B. === 

### 43.8%Tech was slightlyirritating. ThePrimary

### Irritation Index (PIl) 

### is 1.0. with the author the testmaterial

18

### Reviewer: ORNL Date: July 16,2008 RiskManager (EPA):
STUDYTYPE: Dennal Sensitization guinea pig; OPPTS 870.2600; OECD406 

### TEST MATERIAL: Paraquat43.8% Tech (-48% paraquat dichloride; LotNo. notreported, PSLReference No. 061026-40; 

### dark liquid,

### pH 3 as a 

### 1 % w/w 

### solution, soluble in water) Lowe, C. (2007) Paraquat43.8%

- Dermal Sensitization Study pigs 

### (Buehler Method). StudyNumber 21082. EurofinslProduct Safety

..........'VL

... VL

.......>

### 2394 US Highway 130,**Dayto~** 

### NJ 08810. 12,2007. Amended 1,2007. MRID 47091111**~~=;.;::;.::;'** 

### Source Dynamics 10039 

### E. North Scottsdale, In a

### dennal study (MRID 47091111) withParaquat 43.8% (-48%paraquatdichloride; No. not reported; 

### pH 3.98 

### as 1 % w/w

### solution), 30 male young adu)t albino guineapigs (body 

### Hill Breeding Labs, Chehnsford, MA) were using BuehlerMethod. test were induced with 0.4 ofundiluted test material for 

### six 25 

### rom Hill Chambersthat were . secured and wrapped withnon-allergenic adhesive tape. The was repeated once week for three consecutive weeks. to the 

### ofirritation noted afterthe first induction, mLofan 80% w/w

### testmaterial distilled water was used for the second and third inductions. Twenty
...sevendays 

### after the 

### first induction, the test animals were challenged with 0.4roL ofa 

### 12% w/w 

### testmaterial in distilled waterunder occlusion to naive sites. naive control animals were with 0.4 mLofa 12%1 

### test material in distilled waterunder occlusion at challenge. Reactions were scored24 and 48 hours after test material applications. animals were found dead during the inductionphase andthree animals were found priorto chaIIenge. After consecutiveweekly**inductions~** 

### 5114 

### animals and 4114 

### anUnals had reactions at and 

### 48 hours 

### after challenge. 

### Based on

### theresults ofthis 

### study, Paraqu.at

### 43.8% 

### Tech was 

### a dermal sensitizer. 

### The mean Challenge scores were 0.30 and 0.54 

### for naive control and 

### testanimals, respectively, 

### at24 hours and 0.15 and 0.50 fornaive control andtest animals, respectively, at48

### hours. This study is classified as 

### acceptable. It 

### does satisfy guidelinerequirements for a dermal sensitization study(OPPTS 870.2600; 406) in the guineapig. and dated Quality Assurance and DataConfidentiality statements wereprovided.

19 

## <{;\

### 1",,,,£11\""" dichloride)



### PROCEDURE: A. Induction: The animals were induced and challenged accordingto the Buehlermethod. The dorsal and 

### flank areas of

### 20 test guinea pigs were clipped prior to each treatment. For induction, 0.4 mLofundiluted testmaterial was applied to the animal using a rom 

### Hill Top Chamber and secured withnon-allergenic adhesive tape. Thechamber was removed after six hours and excess testmaterial removed. Theprocedurewas repeated once each week three consecutive weeks. Due to 

### the severity ofirritation noted after the first :induction, 0.4 mL ofan 80% 

### wlwtestmaterial in distilled waterwas used for the second and third inductions. Reactions were scored and 48 hours after theinduction applications. B. Challenge: Twenty-seven days after the first induction, the test animals were challenged with 0.4 mL ofa 12% 

### wlw test in distilled waterunder occlusion to naive for 6 hours. Reactions were scored 24 and 48 hours after challenge application. C. Naive 

### control: dorsal and flank 

### areas of 10 naive control animals were dipped priorto treatment challenge, the control group was treated with 0.4 mL ofa 12% 

### wlw test in distilled water for 6hours. Reactions were scored 24 and 48 hours following challenge application. RESULTS and DISCUSSION: A. Three animals were found dead the induction phase and three animals were found dead prior to challenge. Prior to death, threetest animals were hypoactive and exhibited irregularrespiration andlor unthrifty appearance. the survivingtest animals also exhibited hypoactivity aftertheinduction phase. The application dose wererelocated for the third induction due to previous desquamation/eschar. faint to moderate erythema 

### (0.5-2) was noted on 17/17

### test animals overthe course three inductions. 

### Very faint erythema was noted on 6/10 

### naive control animals 24hours after challenge with clearance on3/6 

### control animals 48 hours after challenge. of fourteen test animals exhibited ofa sensitizationresponse (faint erythema [1

## J) at 24 hours and four offourteen at48 hours after chaHenge. 

### Very faint erythema 

### (0.5) was noted for most other sites after challenge. Therefore, the test was a dermal sensitizer. B. Thereport included the ofapositive control (alphahexylcinnamaldehyde) study#20608 conducted within months oflliecurrent study; the results were appropriate. reviewer with the studyauthorthat the test material was
D. Therewas an error Table 6 on 22 the challengephase skin reaction scores. This error was corrected and the study was amended on September 11,2007. 20**(~"~.n""** dichloride)


### 1. DPBARCODE: DP353730 

### PC CODE: 061601 

### CURRENT DATE: July 15, 2008 4. 

### TEST MATERIAL: 

### Paraquat .8% Tech (-.-48% paraquatdichloride; Lot No. notreported, fPrpnf'P 

### No. 061026-4G; dark liquid) pH 3.98 as a 1 % w/w solution, soluble 

### in water 

### Study/SpecieslLab Stud '# / 

### Date Acute toxicitylrat Eurofins/Product 

### Safety Laboratories 

### 21077/March 15,2007 dennal toxicity/rat EurofinsIProduct Safety Laboratories 

### 21078/F ebru 2007 Acuteinhalation toxicity/rat EurofinslProduct 

### Safety Laboratories 

### 21079/March 14, 2007 Primary irritation/rabbit InvereskResearch, Scotland 

### S012lS/February 12, 

### MRID 47091107

47091108

47091109

46098805

Primarydeonal irritation/rabbit 

### 47091110 EurofinslProduct Safety Laboratories

Laboratories 

### 21082/Februa 12,2007 47091111 

### Results Tox. Core Cat. 

### LDso 254

### roglkgbw 

### II A

LDso > 2000

### mglkg bw III males, females combined A



### LCso < 

### 0.051 

### mgIL I

H

......**~**..., 

### females combined



### U

Slightlyirritating 

### IV 

### A

Sensitizing 

### A

Core 

### Grade Key: A = 

### Acceptable, S == 

### Supplementary, U 

## =Unacceptable, W 

## =Waived

21DATE OUT: SUBJECT:

FROM:

TO: 01[ OCTOBER [2008 PRODUCT CHEMISTRY REVIEW OF MP [ X] EP [ ] DP No.; EPA FUe Symbol No.: PRODUCT NAME:**~==~~** COMPANY: Helm Acro US, Inc. FOOD USE [ X] INTEGRATED FORMULATION [X] PCC: Q61601 Decision No. 393061 ACTION CODE: R310 Hari Mukhoty DVM. PHD Product Team

# ~. Review Branch / RD (7505P) Hope Johnson / James Tompkins, RM 25 Herbicide Branch / RD (7505P)

The Registrant has submitted one 06/06/2008, a product proposed label dated 

### 06/05/2008 under File symbol 74530-GT (or '''',..,'''''1''<:1''''

.... of the proposed product The product chemistry data have been submitted under MRIDs: 473897-01, 03, and -04. The applicant claims that the proposed product is substantially similar (me-too) to another product under EPA No, 70552-1 (Product name: ParaquatTechnicel Concentrate). The cited product was conditionally registered on 05/19/2005 and the label was found 08/21/2008. The product chemistry data for the cited product were reviewed and were found on 

### 05/16/2005. The MUP is manufactured by Helm Shanghai in China. Labeltext indicates that this OreJIDO!300 MUP can be formulated into products with food uses, TRB has been requested to evaluate the product chemistry data required the registration of the proposed basic MUP, and to determine if the proposed basic product is substantially similar to the cHad basic product. SUMMARYOFFINDINGS: 1, The proposed MUP contains one active ingredient: Paraquat dichloride (43.8%). 2. The overall mean of the active ingredientfrom the five batch analysis is 43.78% [MRID 473897-02, Page 4 of 126]. 3. The nominal concentration of the active ingredient used in this formulation is 43.8%. The nominal concentration of the active ingredient matches with the label claim. This is in compliance with PR Notice 91-2. The certified limits for active and inert ingredients, and the impuritIes <Xlmply with 40 158.350 (b) (2). 4. The CSF of the proposed MUP (dated 06/06/2008) is filled out completely and correctly. This CSF has been reviewed and the inert ingredients are approved for food use by I.IA Branch on 9/30/2008. Inert branch mentioned a note to the PM with respect to the restrictions on the use of ona inert used in this product last page of this review].

1DP**BAI~C()De** No.: 353729 File sVlln"'n No.:**74530~GT** PRODUCT NAME: ParaquatTC. 

### to guidelines 830.1550 (product identity and 830.1650 (description of

(certified limits) the 158.335, 158.340, and 158.350


### 6.

GC-MS 

### was used to determine analytical techniques can also be aDDlled for Fnt'nrr.p.m,.,.ntAnalytical Method [830.1800
- see Page 18 of appendix]. ",,,,<:.m,·o:.Tru Group A and I':nrTf'l«:l:lnn characteristics 1''''

....'"

.....'''"'''''''J il:>1.UU"';;;:>. were <::rn.. ",n"" stability (830.6317)

two studies are in 473897-01,
8. The proposed product is not SUI)Sllimually similar the cited The concentration ofthe active used in the is lowerthan the lowercertified limit of the cited product. The**propo~)ed** product contains additional to the cited product table of comparison of impurities, Pages 21-22 of
CONCLUSIONS: 1, TRB has reviewed the the MUP. and hasfound it to be acc:aPltable. 2. The propo!:.ea product is not 11'1

..,nTlT"'l'" to the cited product [see item

### # 8 above]. 3. Product data stability and corrosion**Ch~lra(~teristi(::s** ""'uu:,,"<>. 4. The**N'>I'lI«:ltr~r'"** data an The results must exc;epl:lon ofane year storage (830.6317) corrOSion (830.6320) nn<,,,,n/<:l

..,,,,,,,,, be made at 0, 3,6, 9, and 12 month intervals. and hard copy

2BARCODE No.: 353729 EPA File Symbol No.: 74530-GT PRODUCT NAME: TC. PRODUCT CHEMISTRY DATA 830 Group A)

Group A Data Required MRIDNo. Fulfilled 830.1550. Chemical Identity (same as 

### in Product CSF A 473897-01 dated 06/06/2008) 830.1600. Beginning Materials A 473897-01 830.1620. Production process 

# I A 473897-01 830.1650. Formulation process 

### NIA 830.1670. Discussion of Impurities A 473897-01 830.1700. Preliminary Analysis A 413897-02, -03 830.1 Certified Limits CSF dated 06/06/2008) A 473987 ·01 830.1800. Enforcement Analytical Method A 7-02, -03

A = AC(:eotable

3DP BARCODE No.: EPA File Symbol No.: 74530-GT PRODUCT NAME: Paraquat TC,

Group B

A A Liquid 830,6304. Odor A 47389701 mild odor,stench 830.6313. Stabilityto normal and elevated A Hygroscopic, 47389701 temp, metals and metal ions Corrosive to metals, hydrolyzes under alkaline conditions, & photochemical!
830-6314. Oxidation/Reduction action- A with 47389701 Chemical incompatibility AI, slightly corrosive with Zn & but non-corrosive with polyethylene

830.6316. Explodability 

### A Not explosive 47389701 in nQrmal and use conditions 830.6317. Storage stability 

### G One year long study data
830.6319. Miscibility A Miscible 47389701

4 

# ®830.6320. Corrosion Characteristics G One year long study data required 830.7200. Melting pOint A ! 340Q C 47389701 830.7220. Boiling point A 170-180Q C 47389701 830.7050. UV/visible lightabsorption N/A Formulated MUP 830.7370. Dissociation Constant N/A Formulated MUP 830.7550. Partition Coefficient A Kow logP = -4.5 47389701 at20Q C S30.7950. Vapor Pressure A sO.0001 Pa at 47389701 20Q C 830.7840. Solubility (Cited for water) A Not soluble in 47389701 acetone & hexane, freely soluble in water 620 gil 830.7000. pH A 4.9 (1% aq) 47389701 830.7300. DensitylTrue Density A 1.146 g/mL at 47389701 20QC Explanations: A

## =The Requirements Were Fulfilled; N

## =The Requirements Were Not Fulfilled; NA = Not Applicable; G 

## =Data Gap; U = Requires Upgrading; I = Incomplete or In Progress; W = Waived.

5

### Page is not included s copy. Pages 90 through 107 are not luded in this copy. The material not included contains the following type of information: 

### Identity of product ingredients. Identity of product X Description of the product manufacturing process. Description of qual control procedures. Identity of the source of product ingredients. Sales or other commercial/f information. A draft product The product confident statement of formula.

Information about a registration action. FIFRA registration The document is a dupl of page(s) The document is not to the request. Internal deliberat ormation.

----

### Attorney-Client work product. Claimed Confident by submitter upon submission to the Agency. Personal Privacy Information The information not included is ly considered confidential by product registrants. If you have any questions, please contact the individual who prepared the to your request.

### Document Processing Desk (RD ) Office of Pesticide Programs (7504P) U.S. Environmental Protection Agency One Potomac Yard, Room S-4900 2777 S. Crystal Drive Arlington, VA 22202-4501


### Attention: Ms. Hope 

### A. Johnson Registration Division 

# HELm FlGRO US, INC. 8295Tournament Drive, Suite 310 Memphis, Tennessee 38125 Phone: (901) 312-1525 Fax: (901) 312-1535 

### Via Courier Delivery June 13, 2008



### Subject: Paraquat TC (EPA-Reg.No.74530
- GT), OPP Decision No.: 0-391789 Resubmission ofApplication for "me-too" registration Dear Ms. Johnson: This submission is in response to your recent e-mail dated June 5th 

### 2008 to Marshall Wixson and our discussion over the phone. Herewith, HELM Agro US'lnc. is withdrawing all previously submitted material regarding the subject application, and we request replacing all the materials with the enclosed information. As indicated earlier, this is an application for a new "me-too" registration ofthe active ingredient, Paraquat Dichloride, being used as a Manufacturing Use Product (MUP) in formulating registered End-Use Products. The product is very similar in its composition and labeling to existing products, such as Paraquat Dichloride Technical (EPA Reg. No. 83558-5), and Paraquat Technical Concentrate (EPA Reg. No. 70552-1). Enclosed you will find the following information/administrative materials in support ofthe subject application: 1. EPA Form 8570-1: An executed "Application for Pesticide Registration" (OPP Identifier # 259593). 2. Bibliography ofSubmitted Studies , J. 

### One copy ofthe Bibliography ofthe previously submitted studies witH assigned IVIRID numbers.

J, •

### 3. Proposed Label Five copies ofthe proposed Paraquat TC label. 5. Confidential Statement of Formula One copy ofthe Confidential Statement of Formula (CSF) dated June 6, 2008, and the appropriate MSDS of the emetic and colorant as listed on the CSF. 6. Certification with Respectto Citation of Generic Data Helm is using the cite-all option underthe selective method to satisfy the data requirements for this product application as indicated on the executed EPA form 8570-34 with respect to Citation of Generic Data. 7. Data Matrix (EPA form 8570-35) One copy of a data matrix of all previously submitted data (including the generic data submitters) in support ofthe proposed registration is enclosed (one copy for Agency Internal Use, and one copy for Public Use). Helm is offering to pay data compensation to those registrants appearing on the most recent, published Data Submitters List for Paraquat Dichloride dated March 31,2008. 7. Registration Service Fee The PRIA 

### II registration fee ($4,360) has been paid. Payment was received by the Agency as confirmed on April 3, 2008. Please do not hesitate to contact me at610-793-3222 orat bertvolger@comcast.net, if you need any additional information or assistance regarding this application.

Cc: Marshall Wixson
- Helm Sincerely,

# :r~r 

# 1G1r-J
Bert Volger, Ph.D. Consultant for HELM Agro US, Inc.,'7"



### BIBLIOGRAPHY OFSUBMITTED STUDIES Name and Address ofSubmitter: Helm Agro US, Inc. 8295 Tournament Drive, Suite 310 Memphis, TN 38125 

### Product(s): Paraquat TC (Technical) 

### EPA Registration No: 74530-to be assigned Page 1 of 2



### Purpose ofSubmissiou: Submission of data in 

### support of the application for a "me-too" registration ofParaquat TC (Technical) 

### Date ofSubmission: March 31> 2008



### Volume StudyTitle Laboratory, Number ID Number 10f4 

### ParaquatTC HELM, Product Identity and Composition #080328 Description ofMaterials Used DescriptionofProductionProcess Discussion ofthe Formation of Impurities CertifiedLimits Submittal ofSample 20f4 Paraquat TC Inveresk, 5 - Batch Analysis ofParaquat #22220 Dichloride (Preliminary analysis, amended report) 30f4 Paraquat TC Inveresk, 5 - Batch Analysis ofParaquat #25044 Dichloride: Supplementary Studyto Measure Total Terpyridine Content 

## I I 

### ofParaquat Dichloride 

### OPPTS Guideline Reference

Number 830.1550, 830.1600, 830.1620, 830.1670, 830.1750, & 

### 830.1900
830.1700, 830.1750, 830.1800 830.1700**~.' l~**  l..' i,' t,} C,

.... (.. C. (;, {.I (: i. (. 1..

.. C· (; t.- (:

'.J

..... :,,'l"

..: '... \.,

.... \i,;\,;Ot.l 

### EPAMRID Number (Reserved for EPA

C' 

### Use) 47389701

47389702

47389703

t;(, <, 1', ;,

c.\ i.-v c·

o ",i'" '.' b ,,;

ce,c G t: 

### "

### ,. 

### ",

Volume Study Title Laboratory,

Number IDNumber 4 of4 Paraquat TC Microquim, Physicochemical Analysis of Fa

- 25158/03 Technical Grade Products (Color, Physical State, Odor, Flammability, Stability, Corrosion Characteristics, pH, Absorption Spectrum, Boiling Point, Density, Solubility) OPPTS Guideline Reference

Number 830.6302, 830.6303, 830.6304, 830.6315, 830.6317, 830.6320, 830.7000, 830,7050, 830.7220, 830.7300, 830.7840

(, (,.. (,J c.' (1

...**~** 0 <> 

### "

L r. ,-, l't/ t' (. l"'"**:.....~v** Page 2 of 2



### EPAMRID

Number (Reserved for EPA Use)

47389704

,**~~** (, 1...' (I

o c C. (:



### 2Please readinstructions on reverse before completing for" Form ApproVf QMB No. 2070-0060. Approval expires 05-31-98 ) 

# &EPA United States Environmental Protection Agency Washington, DC 20460 

## [R] 

# D D Regis[ration Amendment Other OPP Identifier Number 259593


### Application for Pesticide
- Section I 1. Company/Product Number 74530-GT 4. Company/Product (Name)

Paraquat TC
5. Name and Address ofApplication (Include ZIP Code)

Helm Agro US, Inc. 8295 Tournament Drive, Suite 310 Memphis, TN 38125 

# D DD Check Ifthisis a newaddress

Amendment
- Explain below. Resubmission in response to Agency letter dated

D Notification
- Explain below. 2. EPA Product Manager Hope Johnson 3. Proposed Classification PM#PM 01 

## IxI None D Restricted
6. Expedited Review. In accordance with FIFRA Section 3(c)(3) (b)(i), my product is similar or identical in composition and labeling to: EPA Reg. No. 70552-1 Product Name: Paraquat Technical Concentrate 

### Section -II 

# D Final printed labels in response to Agency lelter dated

______ _ D "Me Too" Application. 

## ffi Explain below. Explanation: Use additional page(s) if necessary. (For Section I and Section 11,)

Subject: OPP Decision Number: 0-391789 Resubmission ofapplication for a "me-too" registration ofa new manufacturing use product, Paraquat TC, that requires reviews of product chemistry data (Non-fast track; PRIA EPA# R310, EPA decision review time of 6 months, fee 

## =$4,360); this application replaces the one ofApril 30, 2008. Contact by EMAIL: bertvolger@comcast.net
1. Material This ProductWill Be Packaged In: Child-Resistant Packaging DYes 

# D No * Certification mustbe submitted Unit Packaging DYes 

# D No If "Yes", Unit Packaging wgt.

3. Location of Net Contents Information D Label D Container 6. Manner in Which Label is Affixed to Product No. per container 

### Section
- III

Water Soluble Packaging DYes 

# D No If "Yes" Package wgt No. per container

4. Size(s) Retail Container

### ~I

# ==::1 Lithograph

### ~I**==~I** Paper glued 1 

### I Stenciled 

### Section -IV 2. ype of c10ntainer Metal D Plastic

### ~I**=~I** Glass 

### I I Paper 

## :=1====:1 Other (Specify)

5. Location of Label Directions 1 

### I On Label 1 I On Labeling accompanying product D Other

__________ _

1. Contact Point (Complete items directlybelowforidentification ofindividual to be contacted, ifnecessary, to process this application.) Name Title Telephone No. (Include Area Code) Bert Volger Consultant for Phone: 610-793-3222**~**_______________________________**~~~**____**~~H~E~L~M~A~\g~lr~o~U~S~,~ln~c~**______**~~F~a~x:+p7)~P~?~Q.3-1703~~_'**_r3

____**~** Certification**~** 6.**,)at~**Application $ Icertil\tthatthe statements I have made on this form and all attachments thereto are true, accurate and complete. 

# i'**Rec~ived** Iacknowledge that any knowingly false or misleading statement may be punishable by fine or imprisonment or ,(**~Stampl~PJ)"** both underapplicable law. 2. Signature "'\1'7""'

_ 

### ,1_**rh'~** 

### r 3. Title ' ;, }

# ly I '-.-<. " 

### v''f--''V Consultant for HELM Agro US, Inc. j , ' 4. Typed Name 5. Date**~~B~e~rt~V~o~lg~e~r** ___**~~~**__**~**_____**~~**__________**~~06~/~13~/~20~0~8~~~~~~~~~**____**~~~.** EPA Form 8570-1 (Rev. 8-94) PrevIous editions are obsolete. White
- EPA FIle Copy (original) Yellow"- Ap,lllicant CopyForm Approved OMB No. 2070-0060**~;~,.,\** UNITED STATES ENVIRONMENTAL PROTECTION AGENCY**\,~~** 401 M Street, S.w. "O«fI'i.L"#' 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 and 0.25 hours per response for reregistration and special review activities, including time for reading the instructions and completing the necessary forms. Send comments regarding burden estimate or any other aspect ofthis collection of information, including suggestions for reducing the burden to: Director, OPPE Information Management Division (2137), U.S. Environmental Protection Agency, 401 M Street, S.w., Washington, DC 20460. Do not send the completed form to this address. Certification with Respect to Citation of Data Applicant's/ReQistrant's Name, Address, and Telephone Number EPA ReQistration Number/File Symbol Helm Agro US, Inc. 8295 Tournament Drive, Suite 310 Memphis, TN 38125 74530 - x Active Inqredient(s) and/or representative test compound(s) Date Paraquat dichloride June 6, 2008 General Use Pattern(s) (list all those claimed for this product usinQ 40 CFR Part 158) Product Name Terrestrial Non Food, and Terrestrial Nonfood use sites Paraquat TC NOTE: Ifyour product is a 100% repackaging ofanother 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). 

# 0 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 I: METHOD OF DATA SUPPORT (Check one method only) 

# 0 I am using the cite-all method ofsupport, and have included with this form 

# 0 I am using the selective method ofsupport (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 ofdata requirements (the Data Matrix form must be used). SECTION II: GENERAL OFFER TO PAY [Required ifusing the cite-all method or when using the cite-all option under the selective method to satisfy one or more data requirements] 

## [2] I hereby offer and agree to pay compensation, to other persons, with regard to the approval ofthis application, to the extent required by FIFRA.

SECTION III: CERTIFICATION I certify that this application for registration, this form for reregistration, or this Data-Call-In response is supported by all data submitted or cited in the application for registration, the form for reregistration, or the Data-Call-In response. In addition, ifthe cite-all option or cite-all option under the selective method is indicated in Section I. this application is supported by all data in the Agency's files that (1) concern the properties or effects ofthis product or an identical or substantially similar product, or one or more ofthe ingredients in this product; and (2) is a type ofdata that would be required to be submitted under the data requirements in effect on the date ofapproval ofthis application ifthe application sought the initial registration of a product of identical or similar composition and uses. I certify that for each exclusive use study cited in support ofthis registration or reregistration, that I am the original data submitter or that I have obtained the written permiSSion ofthe original data submitter to cite that study. I certify that for each study cited in support ofthis registration or reregistration that is not an exclusive use study, either: (a) I am the original data submitter; (b) I have obtained the permission ofthe original data submitter to use the study in support ofthis application; (c) all periods ofeligibility for compensation have expired for the study; (d) the study is in the public literature; or (e) I have notified in writing the company that submitted the ''It'oId,y.and have offered (I) to pay compensation to the extent required by sections 3(c)(1 )(F) and/or 3(c)(2)(B) of FIFRA; and (ii) to commenCG**1J~~jJti?Jions** to**d'tt~11nin,e** the amount and terms of compensation, ifany, to be paid for the use ofthe study. ; ) I certify that in all instances where an offer of compensation is required, copies ofall offers to pay compensation a:Jd 'ill!idepce ofIt!ejr**d~lgvrry** in accordance with sections 3(c)(1)(F) and/or 3(c)(2)(B) of FIFRA are available and will be submitted to the Agency upon requestt'**Shq~ld** I fail.to produce such evidence to the Agency upon request, I understand that the Agency may initiate action to deny, cancel or suspend the registration of my produ,Ur, sonformity with FIFRA. " ; 

### " 

### , ; I certify that the statements I have made on this form and all attachments to it are true, accurate, and cOI1lJ,.'latJ.) I acknowleage that any knowingly false or misleading statement may be punishable by fine or imprisonment or both under applicable law. > "



### -

# ~.~-{-

# rJ:=;~ ( ) Signature Date Typed or Printed Name and Title' j c 

### , June 6, 2008 Bert Volger, Consultant for Helm Agro Inc. EPA Form 8570-34 (9-97) Electronic and Paper versions available. Submit only Paper version. I 

# j ! 

# I

# IForm Approved OMB No. 2070-0060**/,{on~,.,..,.** UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

## (~) 401 M Street, S.W.**~~LPA(J'I\.C.** WASHINGTON, D.C. 20460 Paper Reduction Act Notice: The public reporting burden for this collection of information is estimated to average 0.25 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 completing the necessary forms. Send comments regarding the burden estimate or any other aspect ofthis collection of information, including suggestions for reducing the burden to: Director, OPPE Information Management Division (2137) U.S. Environmental Protection AgencY,401 M Street, S. W., Washington, D.C. 20460. Do not send the form to this address. DATA MATRIX Date: 06/13/08 EPA Reg No'/File Symbol: Page 1 of 4 74530-to be assigned Applicant's/Registrant's Name &Address: Helm Agro US, Inc. 8295 Tournement Drive, Suite 310 Product: Paraquat TC Memphis, TN 38125 Ingredient: Paraquat dichloride Guideline Reference Numbers, Guideline Study Name MRID Number Submitter Status Note OPP/OPPTS 61-1/ Product Identity and Composition 47389701 Helm Agro US, Inc. Own 830.1550

61-2/ Beginning Materials and Manufacturing 47389701 Helm Agro US, Inc. Own 830.1600 &830.1620 Process 61-3/ Discussion ofthe Formation of Impurities 47389701 Helm Agro US, Inc. Own 830.1670

62-1/ Preliminary Analysis 47389702, 47389703 Helm Agro US, Inc. Own 830.1700

62-2/ Certified Limits N/A Helm Agro US, Inc. Own 830.1750 See submitted CSF

62-3/ Enforcement Analytical Method 47389702 Helm Agro US, Inc. Own 830.1800 44568901 Syngenta Crop Protection, Inc.

63-2/ Color -Technical 47389704 Helm Agro US, Inc. Own 830.6302

63-3/ Physical State -Technical 47389704 Helm Agro US, Inc. Own 830.6303

63-4/ Odor-Technical 47389704 Helm Agro US, Inc. Own 830.6304

63-5/ Melting Point-Technical 40479001 Syngenta Crop Protection, Inc. Own**83G:.72(~0** \. '" "" w**E3:n~** , , t1ensity-Technical 47389704 Helm Agro US, Inc. 

### .. Own 83\:).7380·. ' , EPA Form**857b~3'5 \9~~"F)**  Electronic and Paper versions available. Submit only Paper version. Agency Internal Use CopyForm Approved OMB No.**,,"I«1$r~**.... UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 2070-0060 f 

### ftra 401 M Street, S.W.**~~~** '"'''''''tl''ll(1lt.''':# WASHINGTON, D.C. 20460 Paper Reduction Act Notice: The public reporting burden for this collection of information is estimated to average 0.25 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 completing the necessary forms. Send comments regarding the burden estimate or any other aspect ofthis collection of information, including suggestions for reducing the burden to: Director, OPPE Information Management Division (2137) U.S. Environmental Protection AgencY,401 M Street, S. W., Washington, D.C. 20460. Do not send the form to this address. DATA MATRIX Date: 06/13/08 EPA Reg No'/File Symbol: 74530-to be assigned Page 2 of4 Applicant's/Registrant's Name &Address: Helm Agro US, Inc. 8295 Toumement Drive, Suite 310 Product: Paraquat TC Memphis, TN 38125 Ingredient: Paraquat dichloride Guideline Reference Numbers, Guideline Study Name MRID Number Submitter Status Note OPPIOPPTS

-------- 63-81 Solubility-Technical 47389704 Helm Agro US, Inc. Own 830.7840

--

63-91 Vapor Pressure-Technical 40479001 Syngenta Crop Protection, Inc. Own 830.7950

---

63-101 Dissociation Constant 40479001 Syngenta Crop Protection, Inc. Own 830.7370

63-111 Octanol/Water Partition Coefficient-Technical 40479001 Syngenta Crop Protection, Inc. Own 830.7550

63-12/ pH-', ecnmca, 47389704 Helm Agro US, Inc. Own 830.7000

63-131 Stability-Technical 40479001 Helm Agro Inc. Own 830.6313

63-14/ Oxidation/reduction: Chemical incompatibility 47389704 Helm Agro US, Inc. Own 830.6314

--

63.151 Flammability-Technical 47389704 Helm Agro US, Inc. Own 830.6315

63-16/ Explodability-Technical 47389704 Helm Agro US, Inc. Own 830.6316

63-171 Storage Stability -Technical 47389704 Helm Agro US, Inc. Own 830.6317**~3-~?f** "Corrosion Characteristics-Technical 47389704 Helm Agro US, Inc. Own



## ..

## - Y-l/A/:. ., , ·iJV visible light absorption 47389704 Helm Agro US, Own 830.7050 

## - 

# - EPA Form 8570-35 (9-97) Electronic and Paper versions available. Submit only Paper version. Agency Internal Use CopyForm Approved OMB No. 2070-0060 ;tJ)Kt,,1'100 UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

### ( A'l 401 M Street, S.W.**~, +I~(**  f'fM1\'i,-":.I WASHINGTON, D.C. 20460 Paper Reduction Act Notice: The public reporting burden forthis collection of information is estimated to average 0.25 hours per response for registration activities and 0.25 hours per response i for reregistration and special review activities, including time for reading the instructions and completing the necessary forms. Send comments regarding the burden estimate or any other aspect ofthis collection of information, including "'"':'''' "., for reducing the burden to: Director, OPPE Information Management Division (2137) U.S. Environmental Protection Agency, 401 M Street, S. VV.,VVashington, D.C. 20460. [)o not send the form to this address. DATA MATRIX

• ------- Date: 06/13/08 EPA Reg No.lFile Symbol: 74530-to be Page 3 of 4 assigned Applicant's/Registrant's Name & Address: Helm Agro US, Inc. Product: Paraquat TC 8295 Tournement Drive, Suite 310 Memphis, TN 38125

---------- Ingredient: Paraquat dichloride Guideline Reference Numbers, Guideline Study Name MRID Number Submitter Status Note OPPIOPPTS

......... _ ......... 81-11 Acute Oral Toxicity
- Rat 47091107 Source Dynamics LLC Pay 870.1100

..

81-2/ Acute Dermal Toxicity-Rabbit 47091108 Source Dynamics LLC p, 870.1200 I

- Acute Inhalation Toxicity-Rat 47091109 Source Dynamics LLC Pay 870.1300

.......

### _ ...

------- ------- 81-41 Primary Eye Irritation-Rabbit 46098805 Sinon Corp. Pay 870.2400 , .. --------- 1-5/ Pay Primary Dermal Irritation-Rabbit 47091110 Source Dynamics LLC 870.2500 

## -

... 81-61 Dermal Sensitization in Guinea Pigs 47091111 Source Dynamics LLC Pay 870.2600 Generic Paraquat Data Syngenta Crop Protection Pay Generic Paraquat Data The Ortho Business Group Pay

----------**Genf~.ric** Paraquat Data Monsanto Company Pay Generic Paraquat Data Dow Elanco Pay Generic Paraquat Data Crystal Chemical Company Pay

.. Generic Paraquat Data Makhteshim Agan of North Pay America Inc

.

------- ...- Generic Paraquat Data Spray Drift Task Force Pay Generic Paraquat Data EDM Industries Inc. Pay Generic Paraquat Data Outdoor Residential Exposure Pay Task Force LLC Generic Paraquat Data

........ ------- Agricultural Reentry Task Force PayGeneric Paraquat Data FIFRA Endangered Species Task Pay Force EPA Form 8570-35 (9-97) Electronic and Paper versions available. Submit only Paper version. Agency Internal Use CopyForm Approved OMS**.§','I."DII1"~** UNITED STATES ENVIRONMENTAL PROTECTION AGENCY No. 2070-0060

. ft"

## t~l 401 M Street, S.W.**"""<~** WASHINGTON, D.C. 20460
Paper Reduction Act Notice: The public reporting burden for this collection of information is estimated to average 0.25 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 completing the necessary forms. Send comments regarding the burden estimate or any other aspect ofthis collection of information, including suggestions for reducing the burden to: Director, OPPE Information Management Division (2137) U.S. Environmental Protection Agency, 401 M Street, S. W., Washington, D.C. 20460. Do not send the form to this address. DATA MATRIX Date: 06/13/08 EPA Reg No.lFile Symbol: 74530-to be Page 4 of4 I assigned , Applicant'S/Registrant's Name & Address: Helm Agro US, Inc. 8295 Tournement Drive, Suite 310 Product: Paraquat TC Memphis, TN 38125

--------- Ingredient: Paraquat dichloride Guideline Reference Guideline Study Name MRID Number Submitter Status Note Numbers, OPP/OPPTS

........- Generic Paraquat Data Residential Exposure Joint Pay Venture

--------- Generic Paraquat Data Agricultural Handlers Exposure Pay Task Force**(~eneric** Paraquat Data Griffin Corporation Pay Generic Paraquat Data Source Dynamics Pay Generic Paraquat Data Sinon USA Inc. Pay GenericJ=>araquat Data Celsius Property, BV Pay Generic Paraquat Data Generic Endangered Species Pay Task Force Generic Paraquat Data Residential Exposure Joint Pay Venture

------- Generic Paraquat Data Agricultural Handlers Exposure Pay Task Force

----- Signature:

# .~+ 

# [rt:;r:-=: Name and Title: Bert Volger, Ph.D. Consultant for HELM AGRO US Inc. Date: 6/13/2008

. .. p y t-'ap/,o-ft.t1),

### (~.)**1?--1l~r,,"'"** UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 401 M Street, S.W. WASHINGTON, D.C. 20460 Form Approved

Paper Reduction Act Notice: The public reporting burden for this collection of information is estimated to average 0.25 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 completing the necessary forms. Send comments regarding the burden estimate or any other aspect ofthis collection ofinformation, including suggestions for reducing the burden to: Director, OPPE Information Management Division (2137) U.S. Environmental Protection 401 M Street. S. W

.. Washinoton. D.C. 20460. Do not send the form to this address.

Date: 06/13/08 Applicant's/Registrant's Name & Address: Helm Agro US, Inc. 8295 Tournement Drive, Suite 310 Memphis, TN 38125 Ingredient: Paraquat dichloride Guideline Reference Numbers, OPP/OPPTS Guideline Study Name DATA MATRIX

MRID NUmber EPA Reg 74530-to Product: ParaquatTC

Submitter Helm Agro US, Inc. Helm Agro nco

Helm Agro US, Inc. Helm Agro US, Inc.

,C:I&>r'trf'lnif' and Paperversions available. Submit Paper version.



## t:>(J o**~** " 

### • 

### "" 

# . , 

## ..**~ ~ ~~**  Page 1 of4

Status Note Own Own Own Own Own See

Own Own Own Own Own Public Use CopyForm**Approved~OMB No~**  

### '""''> UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 2070·0060 

### "111.\

# ~~) 401 M 

### Street, S.W. WASHINGTON, D.C. 20460 Paper Reduction Act Notice: The public reporting burden for this collection of information is estimated to average 0.25 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 completing the necessary forms. Send comments regarding the burden estimate or any other aspect ofthis collection of information, including suggestions for reducing the burden to: Director, OPPE Information Management Division (2137) U.S. Environmental Protection Agency, 401 M Street, S. W., Washington, D.C. 20460. Do not send the form to this address. DATA MATRIX Date: 06/13/08 EPA Reg No./File Symbol: 74530-to be assigned Page 2 of4

--------------- Applicant's/Registrant's Name & Address: Helm Agro US, Inc. 8295 Tournement Drive, Suite 310 Product: Paraquat TC Memphis, TN 38125 Ingredient: Paraquat dichloride Guideline Reference Numbers, Guideline Study Name MRID Number Submitter Status Note OPPIOPPTS Helm Agro US, Inc. Own Syngenta Crop Protection, Inc. Own Syngenta Crop Protection, Inc. Own Syngenta Crop Protection, Inc. Own Helm Agro US, Inc. Own

--------------- Helm Agro US, Inc. Own Helm Agro US, Inc. Own Helm Agro US, Inc. Own Helm Agro US, Inc. Own Helm Agro US, Inc. Own Helm Agro US, Inc. Own Helm Agro US, Inc. Own 

## -_ .. 

### - 

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# ~**r---------------------------------------------------------------------------------------------------------~F~0-rm~A-o-or-o-ve-d-O--M~B-N-o-.-2-0-70---0-06-0--1** ----**/'fllJT~~,**

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# - \ 1 , 

### '# 

# -< UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 401 M Street, S.W. WASHINGTON, D.C. 20460 Paper Reduction Act Notice: The public reporting burden for this collection of information is estimated to average 0.25 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 completing the necessary forms. Send comments regarding the burden estimate or any other aspect ofthis collection of information, including suggestions for reducing the burden to: Director, OPPE Information Management Division (2137) U.S. Environmental Protection Agency, 401 M Street, S. WashinQton. D.C. 20460. Do not send the form to this address.

Date: 06/13/08 Applicant's/Registrant's Name & Address: Helm Agro US, Inc.
Ingredient: Paraquat dichloride 8295 Tournement Drive, Suite 310 Memphis, TN 38125

Guideline Study Name DATA MATRIX

MRID Number

EPA Form 8570-35 (9-97) Electronic and Paperversions available. Submit only Paper version. 74530-to be
Product: Paraquat TC

Submitter Status

Source Dynamics LLC Source Dynamics LLC

Pay FIFRA Endangered Species Task 

### I Pay Force Page 3 of4

Note

Public Use Copy**/1StItT~~,**

### t~l**\~** ..**(~(,:#** UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 401 M Street, S.W. WASHINGTON, D.C. 20460 Form Approved OMB No. 2070-0060

Paper Reduction Act Notice: The public reporting burden for this collection ofinformation is estimated to average 0.25 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 completing the necessary forms. Send comments regarding the burden estimate or any other aspect ofthis collection of information, including suggestions for reducing the burden to: Director, OPPE Information Management Division (2137) U.S. Environmental Protection Agency, 401 M Street, S. W., Washinaton. D,C, 20460, Do not send the form to this address.

Date: 06/13/08 Applicant's/Registrant's Name & Address: Helm Agro US, Inc.
Ingredient: Guideline Reference Numbers, OPP/OPPTS

Signature: Paraquat dichloride
Guideline Study Name

# ~f 8295 Toumement Drive, Suite 310 Memphis, TN 38125



# TH DATA MATRIX

MRID Number

EPA Form 8570-35 Electronic and Paperversions available. Submit only Paperversion. Page 4 of4
Product: Paraquat TC

Submitter Status Note Residential Exposure Joint 

### I Pay Venture Agricultural Handlers Exposure 

## I Pay Task Force

Pay Pay Pay

Ph.D. Name and Title: Bert Consultant for AGRO US Inc. 

### I Date: 6/13/2008 Public Use 

# -**~** 

# -

## Paraquat TC (Technical Concentrate) For Formulation ofParaquatHerbicide Products Only ACTIVE INGREDIENT Paraquatdichloride (1,1'-demethyl, 4,4'-bipyridinium dichloride) INERT INGREDIENTS
Contains 3 pounds paraquatcation per gallon. Contains emetic. EPA Reg. No. 74530-xx EPA Establishment No. 

## KEEP OUT OF REACH OF CHILDREN 

# DANGERJPELIGRO POISON 43.8% 56.2% 100.0%

Si usted no entiende la etiqueta, busque a alguien para que se la explique a usted en detalle. (Ifyoudo not understand the label, find someone to explain itto you in detail). 

### • NEVER PUT INTO FOOD, DRINK OR OTHER CONTAINERS • IF SWALLOWED, TAKE IMMEDIATE ACTION AS PRESCRIBED IN FIRST AID 

### STATEMENT.SYMPTOMSARE PROLONGED AND PAINFUL.
NetContents:

HELM AGRO Inc. 8295 Tournament Drive Memphis, TN, 38125 info@helmagro.com DRAFT submitted to EPA: 06-05;-201)8

1

### FIRST AID • Ifswallowed 

## • Speed is essential. Immediate attention is required. Ifavailable, Give an adsorbent such as activated charcoal, bentonite or Fuller's Earth. 

## • Call a poison control centerordoctor immediately for treatment. 

## • Do not give anything by mouth to an unconscious person. Ifin eyes 

## • Hold eye open and rinse slowly and gently with water for IS to 20 mins. Remove contact lenses, ifpresent, after the first S minutes, then continue rinsing eye. 

## • Call a poison control center ordoctor for treatment advice. Ifon skin or clothing 

# • Take offcontaminated clothing. 

# • Rinse skin immediately with plenty ofwater for IS to 20 minutes. 

# • Call poison control centerordoctor for treatment advice. Ifinhaled 

## • Move person to fresh air. 

## • Ifperson is not breathing, call 911 oran ambulance. 

# • Call a poison control centeror doctor for further treatment advice. 

### NOTE TO PHYSICIAN Administer either activated charcoal (1 OOg for adults or 2g1kg body weight in children) or Fuller's Earth (1S% solution: 1 liter for adults or ISmglkg body weight in children. Note: The use of gastric lavage without administration of an adsorbent has not shown any clinical benefit. Do not use supplemental oxygen. Eye splashes from concentrated material should be treated by an eye specialist after initial treatment. With the possibility oflate onset corneal ulceration, 

### it is advised that patients with paraquateye injuries are reviewed by an eye specialist the day after first presentation. Use treatment that is appropriate for chemical bums. Intact skin is an effective barrier to paraquat, howevercontact with irritated orcut skin orrepeated contact with intact skin may result in poisoning

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

for treatment. 

### HOTLINE For medical emergencies involving this product, call CHEMTREC 1-800-424-9300. emergency: ;p II, leak, fire, exposure, or accident, call CHEMTREC 1-800-424-9300 

## PRECAUTIONARY STATEMENTS HAZARDS TO HUMANSAND DOMESTIC ANIMALS DANGERJPELIGRO POISON For chemical

May be fatal if swallowed. Fatal ifinhaled. Do not breathe spray mist. Do not inhale contaminated dust. Causes substantial but temporary eye injury. Do not get in eyes or on clothing. Avoid contact with skin. Harmful ifabsorbed through skin. Wear (goggles, face shield, or safety glasses). , IMPORTANT: The effect ofswallowing paraquat concentrate is far more severe thstn**tba~** which usually results from skin contact or inhalation ofcontaminated plant dust. This product shoJJ1.d

### 1)Q~cause}

### inj~rY if used according to label instructions. J • When handling or mixing concentrate or when exposure to concentrate is possible,

### ~e1r: J ) I
2

### • Dust/mist filtering NIOSH approved respirator with any R,P orHEfilter • Protective clothing (disposable suit/coveralls or long-sleeve shirt and long pants) • Full face shield • Chemical-resistant gloves (Category A) • Chemical resistant apron and shoes plus socks Wash hands before eating, drinking, chewing gum, using tobacco orusing the toilet. 

### REMOVE contaminated clothing and wash separatelyfrom other laundry before reuse. 

### ENVIRONMENTAL HAZARDS This product is toxic to wildlife. Do not discharge effluent containing this product into lakes, streams, ponds, estuaries, oceans, or public waters unless this product is specifically identified and addressed in a National Pollutant Discharge Elimination System (NPDES) permit. Do not discharge effluent containing this product to sewer systems without previously notifying the sewage treatment plant authority. For guidance, contactyour State Water Board or Regional Office ofEPA. 

### PHYSICAL AND CHEMICAL HAZARD This product reacts with aluminum to produce hydrogen gas which may form a highly combustible gas mixture. Do not mix or store in containers, tanks, or such systems made ofaluminum or having aluminum fittings. 

### EQUIPMENT/CONTAINER Flush all equipment with water after use each day. Paraquat is corrosive to aluminum. Aluminum equipment and aluminum structures that are exposed to solution or spillage should be flushed thoroughly with water immediately after use. 

### SPILLAGE DURING TRANSPORT Emergency Action: Notify police and fire departments immediately. For any spill, leak, fire, or exposure in the United States, call CHEMTREC 1-800-424-9300. KEEP PUBLIC AND ANIMALS awayfrom area. MARK ROADS AND WARN OTHERROAD USERS. WEAR face shield, waterproofgloves, waterprooffootwear, and long-sleeve shirt and long pants during decontamination operations. Clean up spills as soon as possible. Cover spill with generous amount of clay or loam soil to absorb liquid, using a stiff broom to ensure intimate contact. Sweep onto shovel and transfer to plastic bag or other disposable container. Repeat operations until contaminated surfaces are dry. Finally, hose spill site with water, iffeasible. 

### DIRECTIONS FORUSE It 

### is a violation ofFederal Law to usethis product in a manner inconsistent with its labeling.



### 3

### READ ENTIRE LABEL. USE STRICTLY IN ACCORDANCE WITH PRECAUTIONARY STATEMENTS AND DIRECTIONS, AND WITH APPLICABLE STATE AND FEDERAL REGULATIONS. Only for formulation into a herbicide for the following uses: 

### TERRESTRIAL FOOD CROP Acerola (West Indies cherry), apricot, asparagus, avocado, banana, blackberry, blueberry, boysenberry, broccoli, cabbage, Chinese, carrot (including tops), cauliflower, cherry, cocoa, coffee, collards, cucumber, eggplant, fig, filbert (hazelnut), garlic, groundcherry (strawberry tomato/tomatillo), guava, hops, kiwifruit, lettuce, loquat, macadamia nut (bushnut), manioc (cassava), melons, melons, cantaloupe, melons, musk, melons, water, mint, nectarine, olive, onion, papaya, passion fruit, peach, pear, pecan, pepino (melonpear), pepper, pepper (chili type), pineapple, pistachio, plum, potato, whitlIrish, prune, pumpkin, raspberry (black, red), rhubarb, small fruits, squash (all or unspecified), strawberry, sugar beet, taro, walnut (English/black), yam, yautia. 

### TERRESTRIAL FOOD+FEED CROP Almond, apple, barley, beans, asparagus, beans, dried-type, beans, mung; beans-succulent (lima); beanssucculent (snap), citrus fruits, corn (unspecified), corn, field, corn, pop, corn, sweet, cotton (unspecified), garbanzos (including chickpeas), grapes, guar, hops, legume vegetables, mint, oats, orchards (unspecified), peanuts, peanuts (unspecified), soybeans, edible, spearmint, sugar beet, sugar crops, sugarcane, sunflower, tomato, turnip, vegetables (unspecified), wheat. 

### TERRESTRIAL FEED CROP Alfalfa, barley, beans, clover, crownvetch, legume vegetables, lespedeza, lupine, pastures, sainfoin, timothy, trefoil, tyfon, vetch, wheat. 

### TERRESTRIAL NON-FOOD CROP Agricultural fallow/idleland, airports/landing fields, commercial/industrial lawns, commercial/institutional/industrial, premises/equipment (outdoor), fencecrows/hedgerows, grasses grown for seed, industrial areas (outdoor), jojoba, nonagricultural outdoor buildings/structures, nonagricultural uncultivated areas/soils, ornamental and/or shade trees, peach (non-bearing, seed beds), recreation area lawns, tomato (post-harvest)/ wood protection treatment to forest products (seasoned). 

### FORESTRY Forestplanting (reforestation programs), pine (forestlshelterbelt), shelterbeltplantings. 

### TERRESTRIAL NON-FOOD Ornamental and/or shade trees, ornamental herbaceous plants, ornamental woody shrubs and vines, noncrop areas such as public airports, electric transformer stations and around commercial bUildings. 

### OTHERS Uses for which USEPA has accepted the required data and/or citations of data that the formulator has submitted in support of registration; and uses for experimental purposes that are in compliance with USEPA requirements. 

### STORAGE AND DISPOSAL Do not contaminate water, food or feed by storage, disposal or cleaning ofequipment. 

### PESTICIDE STORAGE; Store at temperatures above 32· F. Do not contaminate food, foodstuffs, or

4

### drinking water. Do not store next to feed or food, or transport in or on vehicles containing foodstuffs or feeds. For help with any spill, leak, fire or exposure involving this material, call CHEMTREC 1-800-424- 9300. PESTICIDE DISPOSAL; Pesticide wastes are acutely hazardous. Improper disposal ofexcess pesticide or rinsate is a violation ofFederal law. Ifthese wastes cannot be disposed ofby use according to label instructions, contact your State Pesticide or Environmental Control Agency, or the Hazardous Waste representative at the nearest EPA Regional Office for guidance. CONTAINER DISPOSAL: Triple rinse (or equivalent). Offer for recycling or recondition, or puncture and dispose of in a sanitary landfill, or dispose of by other procedures allowed by State and local authorities. CONDITIONS OFSALE AND LIMITATION OFWARRANTY AND LIABILITY NOTICE: Read the entire Directions for Use and Conditions of Sale and Limitation ofWarranty and 

# I Liability before buying orusing this product. lftheterms are not acceptable, return the product at once, . I 

### unopened, and the purchase price will be refunded.

. The Directions for Use ofthis product should be followed carefully. It 

### is impossible to eliminate all risks inherently associated with the use of this product. Crop injury, ineffectiveness or other unintended consequences may result because of such factors as manner of use or application, weather or crop conditions, presence ofother materials or other influencing factors in the use ofthe product, which are beyond the control ofHelm Agro US, Inc. or Seller. All such risks shall be assumed by Buyer and User, and Buyer and User agree to hold Helm and Sellerharmless for any claims relating to such factors. Helm warrants that this product conforms to the chemical description on the label and is reasonably fit for the purposes stated in the Directions for Use, subject to the inherent risks referred to above, when used in accordance with directions under normal use conditions. This warranty does not extend to the use ofthis product contrary to label instructions, or under abnormal conditions or under conditions not reasonably foreseeable to or beyond the control ofSeller or Helm, and Buyer and User assume the risk ofany such use. HELM MAKES NO WARRANTIES OF MERCHANT ABILITY OR OF FITNESS FOR A PARTICULAR PURPOSE NOR ANY OTHER EXPRESS OR IMPLIED WARRANTY EXCEPT AS STATED ABOVE. In no event shall Helm or Seller be liable for any incidental, consequential or special damages resulting from the use or handling ofthis product. THEEXCLUSIVE REMEDY OF THE USER ORBUYER, AND THE EXCLUSIVE LIABILITY OF HELM AND SELLER FOR ANY AND ALL CLAIMS, LOSSES, INJURlES OR DAMAGES (INCLUDING CLAIMS BASED ON BREACH OF WARRANTY, CONTRACT, NEGLIGENCE, TORT, STRlCT LIABILITY OR OTHERWISE) RESULTING FROM THE USE OR HANDLING OF THIS PRODUCT, SHALL BE THE RETURN OF THE PURCHASE PRlCE OF THE PRODUCT OR, AT THE ELECTION OF HELMORSELLER,THE REPLACEMENT OFTHEPRODUCT. Helm and Seller offer this product, and Buyer and User accept it, subject to the foregoing conditions of sale and limitations ofwarranty and ofliability, which may not be modified except by written agreement signed by a duly authorized representative ofHelm.



### 5 IHope: ..Marshall Wixson" <mwixson@helmagro.com> 06/05/200802:19 PM

Thanks for your explanation. within the required deadline. regulatory consultant and has be. Thanks for you time. Regards, Dr. Marshall B. Wixson Manager Product Development Helm Agro US, Inc. 8295 Tournament Dr., Suite 310 Memphis, TN 38125 9011312-1525 901/312 1535 (Fax) 901/216-7530 (Cell)

--- -Original Message-- To Hope Johnson/OC/USEPNUS@EPA ec <bertvolger@eomeast.net>. "'Dr. Renate Bastl-Borrmann'" <r.bastl-borrmann@helmag.eom> bee Subject RE: Pending File Symbol # 74530-GT

We will take this under advisement and respond

Dr. Bert Volger of Ceres Inc. acts as our full authority to speak on our behalf if need

From: Johnson.Hope@epamail.epa.gov [mailto:Johnson.Hope@epamail.epa.govl Sent: 2008-06-05 13:04 To: mwixson@helmagro.com Cc: Tompkins.Jim@epamail.epa.gov Subject: pending File Symbol # 74530-GT Importance: High
Mr. Wixson, In your application for registration for Paraquat TC, you have stated it is a me-too application with Syngenta Crop Protection product 100-1067. In addition you are citing the acute toxicity 6-pack of Syngenta's product as well. However, the pending label submitted is missing the required text from the Syngenta label accepted on May 19, 2005: "This product is to be used only for formulation into herbicides with an acute oral toxicity to dogs (lethal effects) that exceeds 128 mg paraquat ion/kg body weight (602 mg of formulation/kg body weight for a 240 g paraquat ion/L formulation) and that contain an effective emetic that meets FAO specifications, a dye, and an olfactory alerting agent that have been cleared under FIFRA for use in pesticides registered for food use." If you cite Reg.100-1067 as your me-too product and cite acute toxicity data for that product, this language must appear on your label. In addition, if approved; Paraquat TC would not be able to be used for formulation into an herbicide with an acute oral toxicity in dogs that is less than 128 mg paraquat ion/kg body weight, and any end-use product using Paraquat TC as the technical source would have to demonstrate that this requirement is met. We assume that it is not your intention to add this language to thelabel, and therefore you must withdraw this application, or within 10 business days (June 18, 2008) submit revised documentation (data matrix, certification with respect to citation of data, EPA form 8570-1, and a letter explaining the revisions) citing a new me-too product. Please contact me if you have any questions, and respond back with your intentions as soon as possible. Hope A. Johnson U.S. Environmental Protection Agency Office of Pesticide Programs Registration Division Herbicide Branch phone: 703-305-5410 Mail Code 7505PMr. Wixson, Hope Johnson/DC/USEPAIUS 06/05/200802:03 PM 

# /

To mwixson@helmagro.com cc Jim Tompkins/DC/USEPAlUS@EPA bcc Subject Pending File Symbol # 74530-GT

In your application for registration for ParaquatTC, you have stated it is a me-too application with Syngenta Crop Protection product 100-1067. In addition you are citing the acute toxicity6-pack of Syngenta's product as well. However, the pending label submitted is missing the required text from the Syngenta label accepted on May 19, 2005: "This product is to be used onlyfor formulation into herbicides with an acute oral toxicity to dogs (lethal effects) that exceeds 128 mg paraquat ionlkg bodyweight (602 mg offormulation/kg body weightfor a 240 g paraquat ioniL formulation) and that contain an effective emeticthat meets FAO specifications, a dye, and an olfactoryalerting agentthat have been cleared under FIFRAfor use in pesticides registered forfood use." Ifyou cite Reg.100-1067 as your me-too product and cite acute toxicity data for that**produc~** this language must appear on your label. In addition, if approved, ParaquatTC would not be able to be used for formulation into an herbicide with an acute oral toxicity in dogs that is less than 128 mg paraquat ion/kg body weight, and any end-use product using ParaquatTC as the technical source would have to demonstrate thatthis requirement is met. We assume that it is notyour intention to add this language to the**labe~** and therefore you must withdraw this application, orwithin 10 business days (June 18, 2008) submit revised documentation (data matrix, certification with respect to citation of data, EPA form 8570-1, and a letter explaining the revisions) citing a new me-too product. Please contact me ifyou have any questions, and respond backwith your intentions as soon as possible. Hope A. Johnson U.S. Environmental Protection Agency Office of Pesticide Programs Registration Division Herbicide Branch Phone: 703-305-5410 Mail Code 7505P



# ,ril

## Relay Report Your docliment: Pending File Symbol # 74530-GT addressed to: mwixson@helmagro.com hasthe 250 OK. sent 48482A76_19841_103088_1 E881 F4435B following delivery status: What should you do? This message is an informational Delivery Status Notification and does not require any further action. • Your messagewas routed to a server which does not accept responsibility for generating Delivery Status Notifications upon successful delivery. You may assume thatthe message was successfully delivered if no failure message is received. Do not expect a delivery confirmation notice.

EPAHUB111USEPAlUS, DCCMMAIL11IDC/USEPAIUS

To: mwixson@helmagro.com
cc: Jim Tompkins/DC/USEPAlUS@EPA Date: 02:03:34 PM AST Today Subject: Pending File Symbol # 74530-GTRita: ..Marshall Wixson" <mwixson@helmagro.com > 05/12/2008 10:34 AM To Rita Kumar/DC/USEPA/US@EPA cc <bertvolger@comcast.net> bec Subject RE: Deficiencies in your application for Paraquat TC, File Symbol 74530-GT

Please see attached data citation form to correct the deficiencies your listed. Regards, Dr. Marshall B. Wixson Manager Product Development Helm Agro US, Inc. 8295 Tournament Dr., Suite 310 Memphis, TN 38125 901/312 1525 901/312-1535 (Fax) 901/216-7530 (Cell)

-- --Original Message----- From: Kumar.Rita@epamail.epa.gov [mailto:Kumar.Rita@epamail.epa.gov] Sent: 2008-05-09 09:28 To: mwixson@helmagro.com Subject: Deficiencies in your application for Paraquat TC, File Symbol 74530-GT Importance: High

Dear Mr. Wixson: Please see attached letter and screening checklist regarding the deficiencies in your application referenced above. A response to correct these deficiencies must be received from you as soon as possible. (See attached file: scan.pdf) Sincerely, Rita Kumar

EPA citation of data form.pdfForm 8Qproved OMS No. 2070"()060**,~~** 

## .. UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

## (=l 4.,-;::7 401 M Street, S.W. WASHINGTON, D.C. 20460 PapelWork Reduction Act Notice: The public reporting burden forthis collection ofinformation is estimated to average 1.25 hours per response for registration and 0.25 hours per response for reregistration and special review activities, including time for reading the instructions and completing the necessary fonms. Send comments regarding burden estimate or any other aspect ofthis collection ofinformation, including suggestions for reducing the burden to: Director, OPPE Information Management Division (2137), U.S. Environmental Protection Agency, 401 M Street, S.W., Washington, DC 20460. Do not send the completed form to this address. Certificationwith Respect

### to Citation of Data Applicant'sJRegistrant's Name, Address, and Telephone Number EPA Registration Number/File Symbol Helm Agro US. Inc. 8295 Toumament Drive, Suite 310 Memphis. TN 38125 74530 -x Active Inaredient(sl and/or representative test comoound(sl Date Paraquat dichloride April 30, 2008 General Use Pattem(s) (list all those claimed forthis product using 40 CFR Part 158) Product Name Terrestlial Non Food, and Terrestrial Nonfood use sites ParaquatTC NOTE: Ifyour product is a 100% repackaging ofanother purchased EPA-registered product labeled for all the same uses on your label, you do not need to submitthis form. You must submit the Formulator's Exemption Statement (EPA Fonm 8570-27). 

# 0 Iam responding to a Data-Call-In Notica, and have included with this form a list ofcompanies sent offers ofcompensation (the Data Matrixform should be used for this purpose).
SECTION I: METHOD OF DATA SUPPORT (Check one method only) 

# 0 Iam using the cite-all method ofsupport, and have included with this fonm 

# [2] Iam using the selective method ofsupport (orcite-all option a listofcompanies sent offers ofcompensation (the Data Matrixfonm underthe selective method). and have includedwith this form a should be used for this purpose). completed list of data requirements (the Data Matrixfonm must be used). SECTION II: GENERAL OFFERTO PAY [Required ifusing the cite-all methodor when using the cite-all option underthe .selective method to satisfy one or more data requirements] 

# [2] I hereby offerand agree to pay compensation. to other persons, with regard to the approval ofthis application, to the extent required by FIFRA.
SECTION III: CERTIFICATION Icertify thatthis application for registration, this fonm for reregistration, orthis Data-Call-In response is supported by all data submitted or cited in the application for registration, the form for reregistration, orthe Data-Cal/-In response. In addition, ifthe clte-all option orclte-all option under the selective method is indicated in Section I, this application is supported by all data in the Agency's files that (1) concem the properties or effeclsofthis product oran identical or substantially slmHar product, or one or more ofthe ingredients in this product; and (2) is a type ofdata that would be required to be submitted underthe data requirements in effeclon the date ofapproval ofthis application ifthe application sought the initial registration ofa product ofidentical orsimilar composition and uses. Icertify thatforeach exclusive use study cited in support ofthis registration or reregistration, that I am the Original data submitter orthat I have obtained the written permission ofthe original data submitterto cite that study. Icertify thatfor each study cited in support ofthis registration or reregistration that is not an exclusive use study, either: (a) Iam the original data submitter; (b) I have obtained the permission ofthe original data submltterto usethe study in support ofthis application; (c) all periods ofeligibility for compensation have expired forthe 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 tothe extent reqUired by sections 3(c)(1)(F) and/or 3(c)(2)(8) ofFIFRA; and (ii) to commence negotiationsto determinethe amount and terms ofcompensation, ifany, to be paid for the use ofthe study. I certify that in all instances where an offer ofcompensation is required. copies ofall offers to pay compensation and evidence oftheirdelivery in accordance with sections 3(c)(1)(F) and/or 3(c)(2)(8) of FIFRA are available and will be submitted tothe Agency upon request. Should I fail to produce such evidence to the Agency upon request, Iunderstand that the Agency may initiate action to deny, cancel orsuspend the registration ofmy product in confonmitywith FIFRA. I certify thatthe statements I have made onthis fonm andall attachments to Itare true, accurate, and complete. I acknowledge thatany knowinglyfalse or misleading statement may be punishable byfine or imprisonment orboth under applicable law. Signature**~** Date Typed orPrinted Name and Title May 9. 2008 Marshall Wixson, Manager Product Development EPA Form 8570-34 (9-97) Eleclromcand PaperversIons avaIlable. SubmIt only Paperversion

..

### UNITED STATES ENVIRONMENTALPROTECTION AGENCY WASHINGTON, D.C. 20460

OFFlCEOF PREVENTION, PESTICIDES

.AND TOXIC SUBSTANCES 

# ,wI (f1AAsh 

# wi{**t,tJ{X~t7h** Date: 

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# TN 33

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# aT Dear Mr./Ms: 

# IAJIx.s.6/4 Theabove referenced PRIA application was screenedbythe Registration Division's Completeness Check Team and determinedto bedeficient. Please seethe enclosed copyofour screening checklist for the specificdeficiency. Youmust submitcorrections within 7 days ofthe date ofthis notice, to the Completeness CheckTeam. Includethe following Decision Numberonyourcoverletterwith the words 

### "Resubmission For RD's Completeness Check Team" to identifyyourpackage. Decision#D 

# 3 

# q3 () 

# 6 ( RESUBMISSION ForRD's Completeness Check Team Youmay send incorrections via fax or e-mail, provided thatthe material is not Confidential BusinessInformation. Ourfax number is (703) 347-8932. Oure-mail address is: OPP _RD _Completenesss_Screening@epa.gov. Ifyou cannotmeetthis time frame, please contactusfor further discusSions onthis matter. Mytelephonenumberis (703) '31}ft- 

## U 

# q 1 .

Attachment Sincerely, 

# Kit;;**Ku~** Completeness Check Team RegistrationDivision (7505P) U.S. EPA, One PotomacYard 2777 S. Crystal Drive Arlington, VA 22202

### (EPAlOPPUse 

### Only) 4/9/08 ·'

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# bt<x/1 UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D.C. 20460


### May 6,2008

OPP DecisionNumber: D-393061 EPA File Symbol orRegistrationNumber: 74530-GT Product Name: PARAQUAT TC EPA Receipt Date: 02-May-2008 EPA CompanyNumber: 74530 CompanyName: HELM AGRO US, INC. MR. VOLKER HEIDE HELM AGRO US, INC. 8295 TOURNAMENT DRIVE, SUITE 310 MEMPHIS, TN 38125- OFFrCEOF PREVENTION, PEST[CIDES AND TOXIC SUBSTANCES



### SUBJECT: Receipt ofRegistration Application Subject to Registration Service Fee Dear Registrant: The Office ofPesticide Programshas received your application and certification of payment. 

### Ifyou submitteddata withthis application, the results ofthe PRN-86-5 screen will be communicated separately. Duringthe administrative screen, the Office ofPesticide Programs has determined that this Action is subject to a Pesticide Registration Service Fee as defined in the Pesticide Registration Improvement Act. TheAction has beenidentified as Action Code: R310 NEW PRODUCT;NON-FASTTRACK (INCLUDES REVIEWS OF PRODUCT CHEMISTRY;ACUTETOXICITY;PUBLIC HEALTH PEST EFFICACY); No additional paymentis due at this time. Ifyou have any questions, please contact thePesticide Registration ServiceFee Ombudsman at (703) 305-6249. Sincerely, 

# 1 JVuZQLJL

# [)~ Front EndProcessing Staff Information Technology & 

### Resources Management Division

# IFee for Servicel 

# {828659 -
This package includes the following
(!) 

# New Registration Amendment

.Studies? i 

# Fee Waiver? ['volpay % 

# Reduction:

_ for Division 

# AD BPPD**(~** 

# RD Risk Mgr. 

# [JJ Receipt No. 

# s-I 828659**~========:** 

# EPA File Symbol/Reg. No. 1 74530-GT Pin
-Punc h Date: 1L--_5_/2_/_2o_o_8-----1 This item is NOT subject to FFS action.
Requested: 

# I**~~J**

# D Granted: 

# I{, 310 Amount Due: 

# $ 

# +,3100

Remarks: 

# Parent/Child Decisions:

Uncleared Inert in Product Date:

# 1i1Jdox

# FEE

# FOR SERVICE

## 004222
U.S. Environmental 

### May 1, 2008 Check No 

### 4222 Document No. 042908 Document Date 04/29/08

REORDER FORM NO. 802 LB1 (1 PART)



### HELM AGRO US INC 8295TOURNAMENT qR""I:.SUITE,319 MEMPHIS; TN 38125 Amount Discount 4,360.00 0.00

Total



## PAY TO THE ORDER OF ""- FOLIR THOUSAND THREEHUNDRED:$IXTYAND.011QO U.S. Environmental Protection**~gency** .DATE May 1, 2008 NetAmount 4,360.00



### 4,360.00
USE WITH COMPANION ENVELOPE #44-005

.> ')) 26-:Y84d**~**

, I

}) j ) ) 

# .'" 

## 004222

}

# .

# . • • .) '> )
AMOUNT *-*-"4,360.00Please readinstructions on reverse before completing fqrm, Form**A~~rove.(:L** OMS No, 2070·0060, Approval expires 05-31-98
"

### \**'"'~'\**



# -- EPA United States 

## [R] ReS:, }ration OPP Identifier Number 

# .. Environmental Protection Agency 

# D Amendment 259583 Washington, DC 20460 

# D Other Application for Pesticide
- Section 

### I 1, Company/Product Number 2, EPA Product Manager 3, Proposed Classification 74530 Venus Eagle 4, Company/Product (Name) PM# 

## [R] None 

# D Restricted

Helm Agro US, Inc, PMG-r

### ~( 8295 Tournament Drive, Suite 310 Memphis, TN 38125 ILambda-Cyhalothrin TC 5, Name and Address ofApplication (/nc/ude ZIP Code) 6, Expedited Review. In accordance with FIFRA Section 3(c)(3)

Helm Agro US, Inc. (b)(i), my product is similar or identical in composition and labeling 8295 Tournament Drive, Suite 310 to: Memphis, TN 38125 EPA Reg, No. 100-1067



# D Checkifthisis a newaddress Product Name: Paraquat Concentrate ES

Section -II 

# D Amendment
- Explain below. 

# D Final printed labels in response to 

# D Agency letter dated Resubmission in response to Agency letter dated 

# D "Me Too" Application. 

# D Notification
- Explain below, 

## ffi Explain below. Explanation: Use additional pagers) if necessary. (For Section I and Section II.)

Application for a "me-too" registration ofa new manufacturing use product, Paraquat TC, that requires reviews of product chemistry data (Non-fast track; PRIA EPA# R31 0, EPA decision review time of6 months, fee

## = $4,360); EMAIL: mwixson@helmaqro.com Section
- III 1. Material This Product Will Be Packaged In: Child-Resistant Packaging Unit Packaging Water Soluble Packaging 2. ype of Ctntainer 

# D Yes 

# D Yes 

# D Yes Metal 

# D No 

# D No 

# D No 

# D Plastic 

### I I Glass 

### I I Paper * Certification mustbe If "Yes", Unit No. per If "Yes" No. per submitted Packaging wgt container Package wgt container 

### I I Other (Specify) 

# I 

# I 3. Location of Net Contents Information 

### f4. Size(s) Retail Container 5, Location of Label Directions 

# D Label 

# D Container 

### I IOn Label 

## I I On Labeling accompanying product 6. Manner in Which Label is Affixed to Product 

### I 

### I lithograph 

# D Other 

## I I Paperglued 

### , I I Stenciled Section 

### -IV 1. Contact Point (Complete items directlybelowforidentification ofindividual to be contacted, ifnecessary, to process this applical;joa.k**~** Name Title**T')I,"()~('n9** No. (InGI\!de 4.rea Code) Marshall Wixson Manager Product Development Phore:B01-312-1525 HELM Agro US, Inc, Fax: 901 -312-1535 ) J '; .;**.~** ., Certification )6) Date**Apeliratio~** Icertify that the statements I have made on this form and all attachments thereto are true, accurate and complete, Receive1 , Iacknowledge that any knowingly false or misleading statement may be punishable by fine or imprisonment or l j, ; (Stamped) both under applicable law. J .' 2. Signature 

# /'--7 3. Title " 3 -:; "'- Manager Product Development > .o: J 4. Typed Name / 5. Date ) 

### ., Marshall Wixson 04/30/2008 I. J



### .. EPA Form 8570-1 (Rev. 8-94) PrevIous eclillons are obsolete. 

### . . White
- EPA File Copy (onglnal) Yellow -Applicant

# crwForm Approved OMB No.**2070~006() .,pt'O."..~**  UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

## (~) 401 M Street, S.W.



### , ... ,,::1 WASHINGTON, D.C. 20460
., c**.~** ,)**~,** .,j

.............**~"** v**:;r--:;--,,~-. -~-**  ""**~** -,' Paper Reduction Act Notice: The public reporting burden forthis collection of information is estimated to average 0.25 hours per response fot"reSjistration activities and O:25'h90rs per response for reregistration and special review activities, including time for reading the instructions and completing the necessary forms. Send comments regardingthe burden estimate or any other aspect ofthis collection of information, including suggestions for reducing the burden to: Director, OPPE Information Management Division (2137) U.S. Environmental Protection Agency, 401 M Street, S. 

### w., Washington, D.C. 20460. Do not send the form to this address. " I " DATA MATRIX**~ ~~**  " ,
........... - EPA Reg No.lFile Symbol: 74530-to Ee" v Date: 04128f08 

## .' Page "1 of 17 assigned Applicant'sfRegistrant's Name & Address: Helm Agro US, Inc. 8295 Tournement Drive, Suite 310 Product: Paraquat TC Memphis, TN 38125 Ingredient: Paraquat dichloride

....... - Guideline Reference Numbers,. Guideline Study Name MRID Number Submitter Status Note OPPfOPPTS 61-1f Product Identity and Composition Helm Agro US, Inc. Own 830.1550 47389701

61-2f Beginning Materials and Manufacturing Helm Agro US, Inc. Own 830.1600 & 830.1620 Process 47389701 61-31 Discussion of the Formation of Impurities Helm Agro US, Inc. Own 830.1670 47389701

62-1f Preliminary Analysis Helm Agro US, Inc. Own 830.1700 47389702,47389703

--------_.

62-2/ Certified Limits Helm Agro US, Inc. Own 830.1750 NfA See submitted CSF

62-31 EnforcementAnalytical Method Helm Agro US, Inc. Own 830.1800 47389702 Syngenta Crop Protection, Inc. r----'

-------------- 44568901 63-2f Color -Technical Helm Agro US, Inc. Own 830.6302 47389704

•

63-3f Physical State -Technical Helm Agro US, Inc. Own 830.6303 47389704

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

63-4f Odor-Technical 830.6304 47389704 Helm Agro US, Inc. Own

63-5f Melting Point-Technical Syngenta Crop Protection, Inc. Own 830.7200 40479001

63-7f Density-Technical Helm Agro US, Inc. Own 830.7300 47389704 EPA Form 8570-35 (9-97) Electronic and Paper versions available. Submit only Paper version. Agency Internal Use Copy



# fForm Approved OMB No.**·,t'A~"'·** UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 2070-0060**f~\** 401 M Street, S.W.

## ~,_6i WASHINGTON, D.C. 20460

" ,,0 'J**.~** ,,' J " Paper Reduction Act Notice: The public reporting burden forthis collection of information is estimated to average 0.25 hours per response fOr**rE.~istration** ac;livities and G:25' h,ours per response for reregistration and special review activities, including time for reading the instructions and completing the necessary forms. Send comments regarCiing the burden estimate or any otheraspect ofthis collection'of information, including suggestions for reducing the burden to: Director, OPPE Information Management Division (2137) U.S. Environmental Protection Agency, 401 M Street, S. W., Washington, D.C. 20460. Do not send the form to this address, --.-".-, DATA MATRIX 

## :**~** v**~** . , v ... J -' Date: 04/28/08 EPA Reg No.lFile Symbol: 74530-to !:Ie'assigned fJage" 2 of 17 Applicant's/Registrant's Name &Address: Helm Agro US, Inc. 8295 Tournement Drive, Suite 310 Product: ParaquatTC Memphis, TN 38125 Ingredient: Paraquat dichloride Guideline Reference Numbers, Guideline Study Name MRID Number Submitter Status Note OPPIOPPTS 63-81 Solubility-Technical Helm Agro Inc. Own 830.7840 47389704

63-9/ Vapor Pressure-Technical Syngenta Crop Protection, Inc. Own 830.7950 40479001

63-101 Dissociation Constant Syngenta Crop Protection, Inc. Own 830.7370 40479001

63-111 OctanollWater Partition Coefficient-Technical Syngenta Crop Protection, Inc. Own 830.7550 40479001

63-121 pH-Technical Helm Agro US, Inc. Own 830.7000 47389704

63-131 Stability-Technical Helm Agro US, Inc. Own 830.6313 40479001

63-14/ Oxidation/reduction: Chemical incompatibility Helm Agro US, Inc, Own 830.6314 47389704

63.151 Flammability-Technical Helm Agro US, Inc. Own 830.6315 47389704

63-161 Explodability-Technical HelmAgro US, Inc. 830.6316 47389704 Own

63-171 Storage Stability -Technical Helm Agro US, Inc. 830.6317 47389704 Own

63-201 Corrosion Characteristics-Technical Helm Agro US, Inc. 830.6320 47389704 Own

N/AI UVvisible light absorption Helm Agro US, Inc. 830.7050 47389704 Own EPA Form 8570-35 (9-97) Electronic and Paperversions available. Submit only Paperversion. Agency Internal Use CopyForm Approved OMS No. 2070- UNITED STATES ENVIRONMENTAL PROTECTION 0060**#"\i.O.T~~**

### (~.) AGENCY 401 M Street, S.W. f,.;,{#1'I.r:Jri.";I" WASHINGTON, D.C. 20460 

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

### . .' Paper Reduction Act Notice: The public reporting burden forthis collection ofinformation is estimated to average 0.25 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 completing the necessary forms. Send comments regarding the burden estimate or any other aspect ofthis collection of information, including suggestions for reducing the burden to: Director, OPPE Information Management Division (?t37> U.,s" .£nvirc;']:;nental Protection Agency, 401 M Street, S. W., Washington, D.C. 20460. Do not send the form to this address. " 

# '.

..' DATA MATRIX ::,•••• J .' Date: 04/28/08 EPA Reg No.lFile Symbol: 74530-to be Page 3 of 17 assigned Applicant's/Registrant's Name & Address: Helm Agro US, Inc. 8295 Tournement Drive, Suite 310 Product: Paraquat TC Memphis, TN 38125 Ingredient: Paraquat dichloride

------------ Guideline Reference Numbers, Guideline Study Name MRID Number Submitter Status Note OPP/OPPTS 71-1(a)/ Avian Acute Oral Toxicity (LDso) 00029001,00102038, Syngenta Crop Protection, Inc. Own 850.2100 - Duck 00160000, 05008363 71-2(a)/ Avian Dietary LCso Syngenta Crop Protection, Inc. Own 850.2200 - Quail 00022923 71-2(b)1 Avian Dietary LCso Syngenta Crop Protection, Inc. Own 850.2200 

### - Duck 00022923 71-4(a)/ Avian Reproduction 00110453,00110454, Syngenta Crop Protection, Inc. Own 850.2300 - Quail 43942604 71-4(b)/ Avian Reproduction Syngenta Crop Protection, Inc. Own 850.2300 - Duck 00110455,43942605

------------ 72-1 (a)/ Warmwater Fish Acute Toxicity Syngenta Crop Protection, Inc. 850.1075 - Bluegill 40098001, 00162737 Own 72-1 (c)1 Coldwater Fish Acute Toxicity 40098001,00162736, Syngenta Crop Protection, Inc. Own 850.1075 - Rainbow Trout 00182738 72-2(a)/ Freshwater Invertebrate Toxicity 40098001,00114473, Syngenta Crop Protection, Inc. Own 850.1010 

### - Daphnia GS0262-028 72-3(a)/ Estuarine/Marine Fish Acute Toxicity Not required· 850.1075 

### - Sheepshead Minnow N/A 72-3(b)/ Estuarine/Marine MolluskAcute Toxicity Not required· 850.102'5 

### - Eastern Oyster N/A 72-3(c)/ Estuarine/Marine Acute Toxicity Not required· 850.1035 

### - Shrimp N/A 72-4(a)/ Invertebrate ChronicToxicity Not required· 850.1300 

## - Daphnia N/A

72-5/ Full Life Stage Fish Not required* 850.1500 

### - Fathead Minnow N/A • RED dated August 1997 EPA Form 8570-35 (9-97) Electronic and Paperversions available. Submit only Paperversion. Agency Internal Use Copy 

# \""",.", i A \

### \~)**~"LI'R~t.** UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 401 M Street, S.W. WASHINGTON, D.C. 20460 Form Approved OMS No. 2070-0060

Paper Reduction Act Notice: The public reporting burden for this collection ofinformation is estimated to average 0.25 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 completing the necessary forms. Send comments**regar9i~n2Jhe.** bl.\rden ef.;timate or any other aspect ofthis collection of information, including suggestions for reducing the burden to: Director, OPPE Information Management Division (2137) U.S. Environmer'fal**Prot~ctio~** Agency, 401 M Street, S. 

### w., Washington, D.C. 20460. Do not send the form to this**address.~·'" '~--~-:-~~---------1** 
Date: 04/28/08 Applicant's/Registrant's Name & Address: Helm Agro US, Inc. 8295 Tournement Drive, Suite 310 Memphis, TN 38125 Ingredient: Paraquat dichloride Guideline Reference Numbers, OPPIOPPTS 81-11 870.1100

81-21 870.1200

81-31 Guideline Study Name Acute Oral Toxicity
- Rat
Acute Dermal Toxicity-Rabbit Acute Inhalation Toxicitv-Rat DATA MATRIX

MRID Number
43685001
43685002 EPA Reg No.lFile Symbol: 74530-to be assigned Product: Paraquat TC**~**____**~87~0~.1~3=00 _~_.~~** __**~**__**~~~~~**___________**.~**____**~~~~**____**~~**__**~~~~~~~~** 81-41 Primary Eye Irritation-Rabbit 870.2400

81-51 Primary Dermal Irritation-Rabbit 870.2500

81-61 870.2600

81-71 870.6100

81-81 870.6200 82-1 (a)I 870.3100 82-1 (b)1 870.3150

82-21 870.3200

82-31 870.3250

82-41 870.3465 Dermal Sensitization in Guinea Pigs Acute Delayed Neurotoxicity Hen Acute NeurotOxiCity Rat Subchronic, 90-day Toxicity Rat Subchronic, 90-day Toxicity Dog 21-Day Dermal Toxicity RabbiUrat 90-Day Dermal Toxicity Rat 90-Day Inhalation Toxicity Rat 43685004 43685005 NIA NIA NIA 00072416 00156313 NIA 00030788,00113718
EPA Form 8570-35 (9-97) Electronic and Paperversions available. Submit only Paper version. Page 4 of 17Form Approved OMS No. 2070-0060 ?17",.,." UNITED STATES ENVIRONMENTAL PROTECTION AGENCY ; ft '" 401 M Street, S.W.**~~~** -**"'~"l1'J\O'f.i.';;#** WASHINGTON, D.C. 20460 .-**~** -

## - .. Paper Reduction Act Notice: The public reporting burden for this collection of information is estimated to average 0.25 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 completing the necessary forms. Send comments regarcjc!;,tlle.Jx:J.den eoemate or any other aspect of this collection of information, including suggestions for reducing the burden to: Director, OPPE Information Management Division (2137) U.S.**Environ~.eJltal :?rot~cti~n**  Abency, 401 M Street, S. W., Washington, D.C. 20460. Do not send the form to this address. 

## - -' "

. DATA MATRIX Date: 04/28108 EPA Reg No.lFile Symbol: 74530-to be Page 5 of 17 assigned Applicant's/Registrant's Name & Address: Helm Agro US, Inc. 8295 Tournement Drive, Suite 310 Product: Paraquat TC Memphis, TN 38125 Ingredient: Paraquat dichloride Guideline Reference Numbers, Guideline Study Name MRID Number Submitter Status Note OPP/OPPTS 82-71 90-Day Subchronic Neurotoxicity Not required' 870.6200
- Rat N/A 83-3(a)1 Development Toxicity Syngenta Crop Protection, Inc. 870.3700a
- Mouse 43949902 Own

- Rat 43964701,00113714 83-3(b)1 Development Toxicity in Rabbits Syngenta Crop Protection, Inc. Own 870.3700b 00096338 83-41 Reproduction (2-Generation) Toxicity in Rats Syngenta Crop Protection, Inc. 870.3800 00126783 Own 83-1 (b)1 Chronic 1-Year Feeding in Dogs Syngenta Crop Protection, Inc. Own 870.4100b 00132474

83-2(b)1 Oncogenicity in Mice Syngenta Crop Protection, Inc. Own 870.4200 00087924,40202403

83-51 Chronic Feeding/Oncogenicity in Rats 00138637,00153223, Syngenta Crop Protection, Inc. 870.4300 40183501,40202401, 40202402,41317401, Own 40218001 83-61 Developmental Neurotoxicity in Rats Not required' 870.6300 N/A 84-2(a)1 Gene Mutation Ames test Syngenta Crop Protection 870.5100 00152690,00152691 Own 84-2(b)1 Structural Chromosomal Aberration 00073487,00152692, Syngenta Crop Protection Own 870.5300 40202404

84-41 Other Genotoxic Effects 00152931,00100442, Syngenta Crop Protection, Inc. 870.5500 00152695,40202405 Own • RED dated August 1997 EPA Form 8570 -35 (9-97) Electronic and Paper versions available. Submit only Paper version. Agency Internal Use Copy

## ~

### BIBLIOGRAPHY OFSUBMITTED STUDIES Name and Address of

### Submitter: Helm Agro US, Inc. 8295 TournamentDrive, Suite 310 Memphis, TN 38125 

### Product{s): ParaquatTC (Technical) 

### EPARegistration No: 74530-to be assigned Page 1 of 2



### Purpose ofSubmission: Submission of data in support of the application for a "me-too" registration ofParaquat TC (Technical) 

### Date ofSubmission: March 31 ,2008



### Volume StudyTitle Laboratory, Number ID Number 10f4 

### ParaquatTC 

### HELM, Product Identity and Composition #080328 Description ofMaterialsUsed Description ofProduction Process Discussion ofthe Fonnationof Impurities Certified Limits Submittal ofSample 20f4 Paraquat TC Inveresk, 5 - Batch Analysis ofParaquat #22220 Dichloride (Preliminary analysis, amended report) i 

### 30f4 Paraquat TC Inveresk, 5 - Batch Analysis ofParaquat #25044 Dichloride: Supplementary Studyto Measure Total Terpyridine Content ofParaquat Dichloride 

### OPPTS Guideline Reference

Number 830.1550, 830.1600, 830.1620, 830.1670, 830.1750, & 

### 830.1900
830.1700, 830.1750, 830.1800 830.1700

L' L' '.' \,.: \,,, '..... .;.. c'**.~** 

### "


### ,. W0 (,

...·J.!_f.· 4.: , l.. y" (.;p"'1.o"",,,, 

### EPAMRID Number (Reserved for EPA Use) 47389701

47389702

47389703

vOU (J 

### " f·.'

... ,**~J ~**  L; .t**~** )
(;...::,. '" o ,}'

(. fJ l..•• 

### ",'. Page 2 of2



### OPPTS EPAMRID Volume Study Title Laboratory, Guideline Number Number IDNumber Reference (Reserved for EPA Number**Us~)** 

### 40f4 ParaquatTC Microquirn, 

### 830.6302, Physicochemical Analysis of FO 25158/03 

### 830.6303, Technical Grade Products (Color, 

### 830.6304, 47388704 

## i Physical State, Odor, Flammability, 

### 830.6315, Stability, Corrosion Characteristics, 

### 830.6317, pH, Absorption Spectrum, Boiling 

### 830.6320, Point, Density, Solubility) 

### 830.7000, 830.7050, 830.7220, 830.7300, " 

### 830.7840

V (.>(.)(;.0,-,**~** (.\ 0 o v



### 2

### Document Processing Desk (RD ) Office of Pesticide Programs (7504P) U.S. Environmental Protection Agency One Potomac Yard, Room S-4900 2777 S. Crystal Drive Arlington, VA 22202-4501

Attention: 

### Ms. Venus Eagle 

# HELm ...bRO US, INC. 8295 Tournament Drive, Suite 310 Memphis, Tennessee 38125 Phone: (901] 312-1 525 Fax: (901]312-1535 

### Via Courier Delivery 

### April 30, 2008

Registration Division
- Product Manager (01) Subject: 

### Paraquat TC (EPA-Reg.No.74530
- to be assigned), Resubmission-For RD's Completeness Check Team Decision #0391789
Dear Ms. Eagle: HELM Agro US Inc. originally submitted on lVIarch 31,2008 an application for a new "me-too" registration of an existing active ingredient, paraquat dichloride, being used only as a Manufacturing Use Product (MUP) in formulating registered End-Use Products. The Agency's Completeness Check Team indicated certain deficiencies (missing Data Matrix, and not acceptable CSF. The identified deficiencies have been corrected. Enclosed you will find the following information/administrative materials in support ofthe subject application: 1. EPA Form 8570-1: An executed "Application for Pesticide Registration" (OPP Identifier# 259583). 2. Bibliography of Submitted Studies One copy ofthe Bibliography of the earlier submitted studies with assigned MRID numbers is enclosed. 3. Proposed Label Five copies ofthe proposed Paraquat TC label are enclosed. , 4. Acute Toxicity Data

### The results ofthe acute toxicity studies for Paraquat TC are based on the results from the existing studies, and assessments by the Agency regarding the reregistration eligibility determination for paraquat dichloride (RED, see Table below). The results show that Paraquat TC has moderate acute oral and dermal toxicity, and demonstrates severe inhalation toxicity to rats. It shows moderate to severe irritation effects to the eye, but only very slight skin irritation to the rabbit, and no skin sensitization in the guinea pig. Based on these data, Paraquat TC is classified as a Toxicity Category I product (see also proposed labeling reflecting these results). ACUTE TOXICITY DATA FOR PARAQUAT DICHLORIDE

EPA-RED, August 1997, p.12)



## Guideline Study Results Category 

## # (MRID) L050 Oral* 344 mg/kg -male 81-1 rat 283 mg/kg -female 

### II (43685001) 81-2 L050 Oermal* >2000 mg/kg 

### III rat (43685002) 81-3 Le50 1 !Jg/L 

### I 4h Inhalation-rat** (00046105) 81-4 Eye Irritation* Moderate to severe 

### II rabbit (43685003) Skin Irritation* Minimal irritation 81-5 rabbit PIS 

### = 0.5 

### IV (43685004) 81-6 Skin Sensitization* Negative 

### N/A Guinea Pig (43685005) " The test material used in these studies was paraquat techmcal concentrate, which is 45.6% paraquat dichloride (cation content 33% w/w). The L050 values are expressed in terms of paraquat dichloride (and not as paraquat cation). "" The test material used in this study was crystalline paraquat dichloride. Purity was not specified, but crystalline paraquat dichloride used in other studies was 99.9% pure. The Le50 value is expressed as paraquat dichloride (and notas paraquat cation). 

### 5. Confidential Statement of Formula One copy ofthe revised Confidential Statement of Formula (CSF), and the appropriate MSDS ofthe emetic and colorant as listed on CSF. 6. Certification with Respect to Citation ofGeneric Data An executed EPA form 8570-34 with respect to citation of**dat~'I,as;been** 

### enclosed.

.
I "



### 2

### 7. Registration Service Fee Under PRIA II, the subject application should be assigned EPA's Action Code R310: New MUP (me-too); registered active ingredient (old a.i); cite-all method ofsupport; 6 months review; $4,360. 8. CODY offee payment Enclosed is a copy of check in the amount of $4,360 that was sent by USPS to: USEPAWashington Finance Center Pesticide Registration Service Fee PO Box 360277 Pittsburgh, PA 15251 We appreciate your expeditious processing ofthis application for registration ofthe subject product and the receipt ofthe stamped, approved label. Please do not hesitate to call on me at 901-312-1525, or contact me bye-mail (mwixson@helmagro.com) or our consultant Bert Volger at 610-793-3222 (bertvolger@comcast.net), ifyou need any additional information or assistance regarding this application.
Sincerely,

Marshall Wixson, Ph.D. Manager Product Development HELM Agro US, Inc.



### 3Form Approved OMB No. 2070-0060

,.CIlT.il1j>; UNITED STATES ENVIRONMENTAL PROTECTION AGENCY i ft \ 401 M Street, S.W.**\~~** ,.'**,~** WASHINGTON, D.C. 20460 . '"**'t)."'tPfl.(J'I't.~** .' '"

. ' . .
- u . Paper Reduction Act Notice: The public reporting burden for this collection ofinformation is estimated to average 0.25 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 completing 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.**Environ.~.e\l~al5'w.tectio[) .~gency,**  401 M Street, S. W., Washington, D.C. 20460. Do not send the form to this address. .' 0**~** 0 '" DATA MATRIX



### .. 0.···


## -**~** Date: 04/28/08 EPA Reg No.lFile Symbol: 74530-to be Page 6 of 17 assigned Applicant's/Registrant's Name & Address: Helm Agro US, Inc. 8295 Tournement Drive, Suite 310 Product: Paraquat TC Memphis, TN 38125 Ingredient: Paraquat dichloride Guideline Reference Numbers, Guideline Study Name MRID Number Submitter Status Note OPP/OPPTS 85-1/ General Metabolism-Rats Syngenta Crop Protection, Inc. 870.7485 00028597,00036297, Own 00028598,00055107, 00028599,00126096 85-2/ Dermal Adsorption/Penetration Syngenta Crop Protection, Inc. 870.7600 00126096,00126097, Own 00126098,00126099 123-1(a) Seed germination & Seedling Emergence (Tier Syngenta Crop Protection, Inc. 850.4225 2) 42639601 Own 123-1(c) Vegetative Vigor (Tier 2) Syngenta Crop Protection, Inc. Own 850.4250 42601001 122-2 (b) Aquatic Plant Growth (Tier 2) Syngenta Crop Protection, Inc. 850.5400 42601002,42601003, Own 42601004,42601005 132-1 (a)/ Foliar Dislodgeable Residue Dissipation Not required* 875.2100 N/A

141-1/ Honey Bee Acute Contact LC50 (Tier 1) Syngenta Crop Protection, Inc. 885.4380 05001991,00028772, Own 00111488,43942603 141-2/ Honey Bee Toxicity
- Residues on Foliage Not required* 850.3030 N/A * RED dated August 1997 EPA Form 8570 -35 (9-97) Electronic and Paper versions available. Submit only Paper version. Agency Internal Use CopyForm Approved ".O

.... i""" UNITED STATES ENVIRONMENTAL PROTECTION AGENCY OMS No. 2070- i 1ft 

## 1 401 M Street, S.W. 0060 

## \

..**~, ~,-."jt**  WASHINGTON, D.C. 20460**~. ~**  .**~** .,"

. v**~** • Paper Reduction Act Notice: The public reporting burden for this collection ofinformation is estimated to average 0.25 hours per response for registration activities and 0.25 hours per response for reregistration and special review activities, induding time for reading the instructions and completing the necessaryforms. 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.**Environ~~.~tall?[p.tectior:~**6Io.gency, 401 M Street, S. W., Washington, D.C. 20460. Do not send the form to this address.

... DATA MATRIX

." .- " ., Date: 04/28/08 EPA Reg No./File Symbol: 74530-to be assigned Page 7 of 17 Applicant's/Registrant's Name & Address: Helm Agro US, Inc. 8295 Tournement Drive, Suite 310 Product: Paraquat TC Memphis, TN 38125 Ingredient: Paraquat dichloride Guideline Reference Numbers, Guideline Study Name MRIDNumber Submitter Status Note OPPIOPPTS 161-11 Hydrolysis Syngenta Crop No MRID: Upton
-**~uideline** 'V'''''''''I< Own 835.2120 NIA fulfilled; review 2/14/85·

161-21 Aqueous Photolysis Syngenta Crop Protection, Inc. Own 835.2240 40562301

161-31 Soil Photolysis Syngenta Crop**'v'~v"""'** Inc. Own No MRID: Pack =guideline 835.2410 NIA fulfilled; 2/14/85·

162-11 Aerobic Soil Metabolism Syngenta Crop Protection, Own 835.4100 41319301

162-21 Anaerobic Soil Metabolism Syngenta Crop Protection, Inc. Own 835.4200 41319302

162-31 AnaerobicAquatic Metabolism Not required' 835.4400 NIA

162-41 AerobicAquatic Metabolism Not required" 835.4300 NIA

163-11 Leaching and Adsorption/DesorptIon Syngenta Crop Protection, Inc. Own 835.1240 40762701

164-11 Field Soil Dissipation 42738701,42738702, Syngenta Crop Protection, Inc. 835.6100 42802101,42802102, Own 41352101,41352102 164-21 Aquatic Field Soil Dissipation NIA ..... Not required" 835.6100

165-11 Confined Rotational Crops 860.1850 41645601 Syngenta Crop Protection, Inc. Own

165-21 Field Accumulation in Rotational Crops NIA Not required" 860.1900

165-41 Sioaccumulation in Fish NIA Not required" 850.1730

165-5 Sioaccumulation in Aquatic Non-Target NIA Waived· * RED dated August 1997 EPA Fonn 8570 -35 (9-97) Electronic and Paperversions available. Submit only Paperversion. Agency Internal Use Copy 

# ,Form Approved OMS**~.r..j't.;** UNITED STATES ENVIRONMENTAL PROTECTION AGENCY No. 2070-0060

, ft >,

# ~~ 401 M Street, S.W. WASHINGTON, D.C. 20460 "**~** " 

### . , " 

## . 

# .

-----

.**~** .' ' 

### :

, Paper Reduction Act Notice: The public reporting burden for this collection ofinformation is estimated to average 0.25 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 completing the necessary forms. Send comments regarding the burden estimate or any other aspect ofthis collection of information, including suggestionsfor reducing the burden to: Director, OPPE Information Management Division (2137) U.S.**Environment:;JL~r9te;:;tiC'J1** Agel1SY, 401 M Street, S. W., Washington, D.C. 20460. Do not send the form to this address. .' '" "," d, d '-J .'" ' '" DATA MATRIX

-

--------- Date: 04/28/08 EPA Reg No.lFile Symbol: 74530-to be assigned Page 8 of 17 Applicant's/Registrant's Name & Address: Helm Agro US, Inc. 8295 Tournement Drive, Suite 310 Product: Paraquat TC Memphis, TN 38125 Ingredient: Paraquat dichloride

------------ Guideline Reference Numbers, Guideline Study Name MRIDNumber Submitter Status Note OPPIOPPTS f--'-'----- Nature of Residues 00065602, 00065604, Syngenta Crop Protection, Inc. 171-4(a) 860,1300

- plants 00091365,00091366 Own

-------- 171-4(b) Nature of Residues 00028596,00028597, Syngenta Crop Protection, Inc. 860,1300


### - Livestock 00028598,00028509, Own 00089748,00114414, 00114422,00117783, 42324302 171-4(c) Residue Analytical Method
- plants 00025269, 00030476, Syngenta Crop Protection, Inc. 860.1340 00032141,00032240, Own 00037058,00090400, 00112663,00114411, 00114421,00114446, 00114453,00114465, 00114466,00138258, 40048401,40098502, 41151508,41151514, 41151519,41151522, 41151528,42217402, 42217403,42217404, 42217405,43492603 171-4(d) Analytical Method
- livestock 00036306,00037058, Syngenta Crop Protection, Inc. Own 860,1340 00112663,00114421, 00114422,40943701, 42217401,43226902, 43226903,43492601, 43969101 

# \Form Approved OMS**,/'ft)87.4~** No. 2070-0060 i .ft ') UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

### \~. 401 M Street, S.W. ,- 

### ..**'tt,.,dI'-~** WASHINGTON, D.C. 20460 '- " 

### . • 0 .J c' J " ,< " Paper Reduction Act Notice: The public reporting burden forthis collection of information is estimated to average 0.25 hours per response for regisfration**activitie~sa'nd** 0.25hours0per response for reregistration and special review activities, including time for reading the instructions and completing the necessary forms. Send comments regarding the burden estimate orany other aspect ofthis collection of information, including suggestions for reducing the burden to: Director, OPPE Information Management Division (2137) U.S.**Environment~.1 f~~te<?tL09**  AgelJt::y, 401 M Street, S. W., Washington, D.C. 20460. Do not send theform to this address. ,,_.___ . _,_.. _._. DATA MATRIX Date: 03/28/07 EPA Reg No.lFile Symbol: 74530-to be assigned Page 9 of 17 Applicant's/Registrant's Name &Address: HelmAgro US, Inc. 8295 Toumement Drive, Suite 310 Product: Lambda-Cyhalothrin Memphis, TN 38125 Ingredient: Paraquat dichloride Guideline Reference Numbers, Guideline Study Name MRID Number Submitter Status Note OPP/OPPTS 171-4(e) Storage Stability 00037057, 00113702, Syngenta Crop Protection, Inc. Own 860.1380 40943702,40943703, 41151511,41151535



### - Crops & animal tissues 41151536,41151537, 41151538,41151539, 41151540,41151541 42217401,42217440 through 42217450, 43954003,43954004 171-40) Magnitude of residues in meatlmflklpoultry/eggs 00036305, 00090978, Syngenta Crop Protection, Inc. Own 860.1480 00114414,00114422, 00117783,00038503, 40943704 171-4(k) Magnitude of Residues
- Crop Field Trials Syngenta Crop Protection, Inc. Own 860.1500 Root and TuberVegetables Groul;!



### - Carrots 00030476



### - Cassava 00160250

- Potatoes 00033612,00091376, 00105060

- Sugar beet roots 00113709,41151514, 42217418



### - Taniers 00160250

- Taro corms 41017901



### - Turnips, roots 00030476



### - Yams 00160250 Leaves of Root and Tuber Vegetables Group

- Sugar beet tops 00113709,41151514, 42217418



### - Taro fOliage 45189501 IR-4 

# \Form Approved OMB ,a'r..f't No. 2070-0060 

# (,,<1 UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 401 M Street, S.W.**"""l~";I'** WASHINGTON, D.C. 20460 

### -, 

### -**~ ~::::**  .,. Paper Reduction Act Notice: The public reporting burden for this col/ection of information is estimated to average 0.25 hours per response for reg,istation**activiti~s** and 0.125**~JOGrs ~er**  response for reregistration and special review activities, including time for reading the instructions and completing the necessary forms. Send comments regarding the burden e'SrirtJate or any other aspect ofthis col/ection of information, including suggestions for reducing the burden to: Director, OPPE Information Management Division (2137) U.S. Environmental Protection Agency, 401 M Street, S. W., Washington, D.C. 20460. Do not send the form to this address.**~** 

### ..:**~-~~~":"'_-_--.r_** DATA MATRIX 

### -

- 

### "

. 

### , .. 

### - - 

## - Date: 04/28/08 EPA Reg No.lFile Symbol: 74530-to b€..&Srsig;,ed**iPag~** 10of 17 Applicant's/Registrant's Name & Address: Helm Agro US, Inc. 8295 Tournement Drive, Suite 310 Product: Paraquat TC Memphis, TN 38125 1 Ingredient: Paraquat dichloride Guideline Reference Numbers, Guideline Study Name MRID Number Submitter Status Note OPPIOPPTS 171-4(k) Magnitude of Residues
- Crop Field Trials Syngenta Crop Protection, Inc. Own 860.1500 Bulb Vegetables Group

- Onions, dry bulb and green 00113680,00136330, 45419901 IR-4 Leafy Green Vegetables (excegt Brassica veg.) Groug

- Lettuce

- Rhubarb 0114474,00139741 00031863 Brassica Leafy Vegetables Group

- Broccoli

- Cabbage 00103245

- Cauliflower 00103245

- Chinese cabbage 00030476

Collards 00030476 00030476 Legume Vegetables Groug

- Beans (succulent, lima, snap & dry) 

### ,

- Guar 00030476,00033223

- Peas (succulent) 00114420

- Pigeon peas 00030476

- Soybean seed &aspirated grain fractions 00147206 00015768,00025268, 00015769 00015771, 00032427,00015772, 00015774,00098579, 00015775, 00030676, 00015770,00031742 00033530,00015773, 00034112,00109728, 00114446,41151524, 

# l,t:J(c 41151530,42217426, 42217438,43226904, 43226904

--Form Approved OMB**;I.O.'-4~** UNITED STATES ENVIRONMENTAL PROTECTION AGENCY No. 2070-0060

### (~.) 401 M Street, 

### S.W.**~ ~"{PfII{fI'-"#**  WASHINGTON, D.C. 20460 'vi**.~'** " J ---------_. y .' ". Paper Reduction Act Notice: The public reporting burden for this collection of information is estimated to average 0.25 hours per response for registration activities and hours per response for reregistration and special review activities, including time for reading the instructions and completing the necessary forms. Send comments regarding the burden estimate orany other aspect of this collection ofinfonmation, including suggestions for reducing the burden to: Director, OPPE Infonmation Management Division (2137) U.S. Environ[l1J'!Jt.i31**E'r;p!ectio~,~gency,** 401 M Street, S. W., Washington, D.C. 20460. Do not send the fonm to this address. .i ,/." DATA MATRIX .J J ,;-".,1...) "'" .

---------------- Date: 04/28/08 EPA Reg No.tFUe Symbol: 74530-to be assigned Page 13 of 17 Applicant's/Registrant's Name &Address: Helm Agro US, Inc. 8295 Toumement Drive, Suite 310 Product: Paraquat TC Memphis, TN 38125 Ingredient: Paraquat dichloride Guideline Reference Numbers, Guideline Study Name MRID Number Submitter Status Note OPP/OPPTS 171-4(k) Magnitude of Residues
- Crop Field Trials (cont.) Syngenta Crop Protection, Inc. Own 860.1500 Cereal Grains Group Barley grain 00114411 Corn, field, grain &aspirated grain fractions 00015751,00023512, 00015752,00015955, 00030647,00016441, 00031744,00016442, 00033223,00016444, 00093182, 00016445, 00023131,41151523, 42217437,43226904 Corn, sweet 00030683, 00033223, 41151506 Oat grain 00114411 Rice grain 42670801 Sorghum grain and aspirated 00023131,00026963, grain fractions 00027178,00033223, 00070872,00113709, 41151531,42217439 Wheat grain and aspirated grain 00027311,00113693, fractions 00114411,00140828, 41151525,42217439 Forage, Fodder, Hay, and Straw of Cereal Grains Group

Barley forage, hay, and straw 00114411**~.r** ..,,*,-**"Al**

### ~# 

## """". UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 401 M Street, S.W. WASHINGTON, D.C. 20460 Form Approved OMB No. 2070-0060

Paper Reduction Act Notice: The public reporting burden for this collection of information is estimated to average 0.25 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 completing the necessaryforms. Send comments regarding t!1t! P1.1rdtlO**8lstim~te** or any other aspect ofthis collection ofinformation, including suggestions for reducing the burden to: Director, OPPE Information Management Division (2137) U.S. Environment",1 Protegtion'Ag<mcy; 401 M Street, S. W., Washington, D.C. 20460. Do not send the form to this address.**~** ..... , .... '.;-'-------------l

Date: 04128/08 Applicant's/Registrant's Name & Address: Helm Agro US, Inc. 8295 Tournement Drive, Suite 310 Ingredient: Paraquat dichloride Guideline Reference Numbers, OPP/OPPTS 171-4(k) 860.1500 Guideline Study Name Magnitude of Residues
- Crop Trials· Forage, Fodder, Hay, and Straw ofCereal Grains Group (cont.)

- Corn, field, forage and fodder

- Corn, sweet, forage, and fodder

- Oatforage, hay, and straw Rice straw Sorghum forage and fodder

- Wheatforage, hay, and straw

Grass Forage, Fodder, and Hay Group DATA MATRIX

MRID Number

00015751,00015752, 00015955,00016441 00016442,00016444, 00016445,00023131, 00023512, 00027972, 00027973, 00030647, 00031519,00031744, 00033208, 00033223, 00093182,41151523, 42217437 00030683, 00033223, 41151506,42217411 00114411

42670801 00026963,00027178, 00070872,41151531, 42217430 00027311,00114411, 41151525,42217401,

42217439,42961401 00033223,00058773, 00114424,00114466, 00117783,00160817, 41151515,41151516, 41151526,42217419, 42217420,42217425 EPA Reg No.lFile Symbol: 74530-to be assigned Page 14 of 17
Product: Paraquat TC

Submitter Status Note Syngenta Crop Protection, Inc. Own#"'''''>.

## (~l 

# ",,,,,,,, UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 401 M Street, S.W. WASHINGTON, D.C. 20460 Form Approved OMS No. 2070-0060

Paper Reduction Act Notice: The public reporting burden for this collection of information is estimated to average 0.25 hours per response for regi.;;tr';'tion activiti&::; and**O.:i.~** hou,:s per response for reregistration and special review activities, including time for reading the instructions and completing the necessary forms. Send comments regarding"'the burden estimate or any other aspect ofthis collection of information, including suggestions for reducing the burden to: Director, OPPE Information Management Division (2137) U.S. Environmental Protection Agency, 401 M Street, S. W., 

### I Washington, D.C. 20460. Do not send the form to this address.**~,"""_~4-_-~.-~-----------t**

Date: 04/28/08 Applicant's/Registrant's Name & Address: Helm Agro US, Inc. 8295 Tournement Drive, Suite 310 Memphis, TN 38125 Ingredient: Paraquat dichloride Guideline Reference Numbers, 

## I Guideline Study Name OPP/OPPTS 171-4(k) Magnitude of Residues
- Crop Field Trials (cont.) 860.1500
- Alfalfa

- Sirdsfoot Trefoil

- Clover
Miscellaneous Commodities

- Artichokes Acerola Asparagus Avacodos Bananas Coffee Cotton, seed, and gin byproducts

- Figs

- Guava

- Hops, cones, dried

- Kiwifruit

- Mint hay

- Okra

- Olives

- Papaya DATA MATRIX

MRID Number

00032140,00114464, 00058774 00114465, 00105061,00114467, 00114405,00126671, 00114421 00128624, 00114424,00165364, 41151501,42217406 00114424, 41151542, 42217434 00114424, 00117783, 41151509,42217414
44125901 00128221 00033532,00113675 GS0262-006 00113709,00139733 00139734 00031739,00033612, 00091372,42217401**00139735,41151502~** 42217407,42961401 00114419 00113686,41151521, 42217435 00088195 00137859 45439901 00139737 00033695 .' EPA Reg No.lFile Symbol: 74530-to b19'aS::iigI1ed 'flage 15 of 17
Product: ParaquatTC

Submitter Status Note Syngenta Crop Protection, Inc. Own

IR-4

IR-4**:\(.OlIt~** '/'A\**i~~ ~(""tP~**  UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 401 M Street, 

### S.W. WASHINGTON, 

### D.C. 20460 <v**~** Form Approved OMS No. 2070-0060

Paper Reduction Act Notice: The public reporting burden for this collection of information is estimated to average 0.25 hours per response for resJsteation activi!iCl$ <,lnd 0,25**';lObr~,.ler** response for reregistration and special review activities, including time for reading the instructions and completing the necessary forms. Send comments regarding' the burden estimate orany other aspect ofthis collection of information, including suggestions for reducing the burden to: Director, OPPE Information Management Division (2137) U,S, Environmental Protection Agency, 401 M Street, S, W., Washington, D,C. 20460. Do not send the form to this address.

Date: 04/28/08 Applicant's/Registrant's Name & Address: Helm Agro US, Inc. 8295 Tournement Drive, Suite 310 Memphis, TN 38125 Ingredient: Paraquat dichloride Guideline Reference Numbers, 

## I Guideline Study Name OPP/OPPTS 171-4(k) 

# IMagnitude of Residues
- Crop Field Trials (cont.) 860.1500
- Passion Fruit

171-4 <I} 860.1700 - Peanut nutmeats, hay, and hulls Peas

- Pineapple

- Pistachios

- Safflower seed and forage

- Strawberries

- Sugarcane

- Sunflower seeds and forage Magnitude of Residues in Processed Food/Feed Citrus fruits

- Coffee

- Corn, field

- Cottonseed

Figs DATA MATRIX

MRID Number
00037056 40098501,40098503 44315001 00114411,41151534, 42217432,42217433 00027550, 00035666, 00113699 00114411 00138258 00114411,00114469 00106570,00114422, 41151512,42217416
00033695 41151529,42217401, 42217428 00114426,41151528, 42217401,42217427 00091372 41151502,42217407, 42961401**j:,0-;$-<0-V-'0'-'¢"~"-'**--.",

.. ,.
EPA Reg No./File Symbol: 74530-to

### t:6":l&si9~led**I~Paa~** 16 of 17
Product: Paraquat TC

Submitter Status Note Syngenta Crop Protection, Inc. Own

### ",'AI'i>.-,\ UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 401 M Street, S.W. Form Approved OMS No. 2070-0060

### ~~ 

# . ;,**,.{"'~** WASHINGTON, D.C. 20460 Paper Reduction Act Notice: The public reporting burden for this collection of information is estimated to average 0.25 hours per response for regiStsation activitiE:'<;

..?':1d 0.25h-oure:.per response for reregistration and special review activities, including time for reading the instructions and completing the necessaryforms. Send comments regarding the burden estimate or any other aspect ofthis collection ofinformation, including suggestions for reducing the burden to: Director, OPPE Information Management Division (2137) U.S. Environmental Protection Agency, 401 M Street, S. W., Washil1gton, D.C. 20460. Do not send the form to this address. " DATA MATRIX Date: 04/28/08 EPA Reg No'/File Symbol:**7453:D,t0~De:** P 1 1 assi ned age 7 of 7 Applicant's/Registrant's Name &Address: Helm Agro US, Inc.
Ingredient: Guideline Reference Numbers, OPPIOPPTS 171-4(1)

231 and 232 Signature: Paraquat dichloride 8295 Tournement Drive, Suite 310 Memphis, TN 38125

Guideline Studv Name Magnitude of Residues in Processed Food/Feed (cont.)

- Grapes

- Hops Mint Olives

- Pineapples

- Plums

- Potatoes

- Sorghum

- Soybeans

- Sugar beets

- Sugarcane

- Sunflower

- Tomatoes

- Wheat Estimation of Dermal and Inhalation Exposure

### /,/~

# ~ MRID Number

44600601 41151521,42217435 00137859,42217401 41151522,42217401 41151533,42217432 41151532,42217401, 42217431 41151508,42217401, 42217413 00114421,41151520, 42217424 00034112 41151519,42217401, 42217423 00114411,00114469, 41151518,42217422 00114422 41151510,42217415 41151517,42217401, 42217421 43618202, 43644201 43644202

EPA Form 8570-35 (9-97)tE:lectronic and Paper versions available. Submit only Paper version. Product: Paraquat TC

Submitter Status Syngenta Crop Protection, Inc. Own

Syngenta Crop Protection, Inc. Own Name and Title: Marshall Wixson, Ph.D. Manager Product Development

HELM AGRO US Inc. Note

Date: 4/28/2008 Agency Internal Use Copy 

# \

## Paraquat TC (Technical Concentrate) ForFonnulation·ofParaquatHerbicide Products Only ACTIVE INGREDIENT Paraquatdichloride (1,1'

### -demethyl, 4,4'

### -bipyridinium dichloride) INERT INGREDIENTS TOTAL Cpntains 3 pounds paraquat cation per gallon. Contains emetic. EPA Reg. No. 74530-xx 

### EPA EstablishmentNo. 

## KEEP OUT OF REACH OF CHILDREN 

# DANGERIPELIGRO POISON 43.8% 56.2% 100.0%



### Si usted no entiende la etiqueta, busque a alguien paraque se laexplique a usted en detalle. (Ifyou do not understand the label, find someone to explain it to you in detail). 

### • NEVERPUTINTO FOOD,DRINK OROTHERCONTAINERS • IF SWALLOWED, TAKE IMMEDIATE ACTION AS PRESCRIBED IN FIRST AID STATEMENT.SYMPTOMS ARE PROLONGEDAND PAINFUL. NetContents:

HELM AGRO Inc. 8295 

### Tournament Drive Memphis, TN, 38125 

### info@helmagro.com DRAFT submitted to EPA: Q.4-jD-2Q08 , j .)

1

### FIRST AID Ifswallowed 

## • Speed is essential. Immediate attention is required. If Give an adsorbent such as activated charcoal, bentonite Earth. Call a poison control cen.ter or doctor immediately for treatment. 'I 

### Do not give anything by mouth to an unconscious person. . Hold eye open and rinse slowly and gently with water for 15 to 20 • 

## • 

# • • mms. R ttl 'f t ft th fi t 5 ' t th emove con ac enses, I presen, a er e Irs mmu es, en continuerinsing eye. 

## • Call a poison control center ordoctor for treatment advice. Ifon skin orclothing 

## • Take offcontaminated clothing. 

## • Rinse skin immediately with plenty ofwater for 15 to 20 minutes. 

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

## • Move person to fresh air, 

## • Ifperson is not breathing, call 911 or an ambulance. 

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

### NOTE TO PHYSICIAN Administer either activated charcoal (100g for adults or 2g/kg body weight in children) or Fuller's Earth (15% solution: 1liter for adults or 15mg/kg body wight in children(. NOTe: The use of gastric lavage without administration of an adsorbent has not shown any clinical

.benefit. Do not use supplemental oxygen. Eye splashesfrom concentrated material should be treated by an eye specialist after initial treatment. With the possibility oflate onset corneal ulceration, it

### is advised that patients with paraquat eye injuries are reviewed by an eye specialistthe day after first presentation, Use treatment that is appropriate for chemical bums. Intact skin is an effective barrier to paraquat, however contact with irritated or cut skin orrepeated contact with intact skin may result in poisoning. Havethe pofuct container or label with you when calling a poison control center or doctor, or going for treatment. 

### HOTLINE For medical emergencies involving this product, call CHEMTREC 1-800-424-9300. For chemiC'J'l1 emergency: Spill, leak, fire, exposure, or accident, call CHEMTREC 1-800-424-9300 

## PRECAUTIONARY STATEMENTS HAZARDS TO HUMANSAND DOMESTIC ANIMALS DANGERIPELIGRO POISON I

!



### May be fatal ifswallowed. Fatal ifinhaled. Do not breathe spray mist. Do not inhale contaminated dust. Causes substantial but temporary eye injury. Do not get in eyes or on clothing. Avoid contact with skin. Harmful ifabsorbed through skin. Wear (goggles, face shield, or safety glasses). 

### IMPORTANT: The effect ofswallowing paraquat concentrate is far more severethan that which usually results from skin contact or inhalation ofcontaminated plant dust. This product should not cause injury if used according to label instructions. When handling ormixing concentrate orwhen exposureto concentrate is possible, wear:

2

### • Dust/mist filtering NIOSH approved respiratorwith any R,P or

## HE filter • Protective clothing (disposable suit/coveralls orlong-sleeve shirt and long pants) • Full face shield • Chemical-resistant gloves (Category A) • Chemical resistant apron and shoes plus socks Wash hands before eating, drinking, chewing gum, using tobacco or using thetoilet. REMOVE 

### contaminated clothing and wash separately from other laundry before reuse. 

### ENVIRONMENTAL HAZARDS This product is toxic to wildlife. Do not discharge effluent containing this product into lakes, streams, ponds, estuaries, oceans, orpublic waters unless this product is specifically identified and addressed in a National Pollutant Discharge Elimination System (NPDES) permit. Do not discharge effluent containing this product to sewer systems without previously notifying the sewage treatment plant authority. For guidance, contact your State Water Board orRegional Office ofEPA. 

### PHYSICALAND CHEMICALHAZARD This product reacts with aluminum to produce hydrogen gas which may form a highly combustible gas mixture. Do not mix or store in containers, tanks, or such systems made ofaluminum orhaving aluminum fittings. 

### EQUIPMENT/CONTAINER Flush all equipment with water after use each day. Paraquat is. corrosive to aluminum. Aluminum equipment and aluminum structures that are exposed to solution or spillage should be flushed thoroughly with water immediately after use. 

### SPILLAGE DURING TRANSPORT 

### Emergency Action: Notify police and fire departments immediately. For any spill, leak, fire, or exposure in the United States, call CHEMTREC 1-800-424-9300. KEEP PUBLIC AND ANIMALS away from area. MARKROADS AND WARN OTHER ROAD USERS. WEARface shield, waterproffgloves, waterprooffootwear, and long-sleeve shirt and long pants duringdecontamination operations. Clean up spills as soon as possible. Cover spill with generous amount of clay or loam soil to absorb liquid, using a stiffbroom to ensure intimate contact. Sweep onto shovel and transfer to plastic bag or other disposable container. Repeat operations until contaminated surfaces are dry. Finally, hose spill site with water, iffeasible. 

### DIRECTIONS FORUSE It is a violation ofFederal Lawto use this product in a manner inconsistent with its labeling.

3

### READ ENTIRE LABEL. USE STRICTLY IN ACCORDANCE WITH PRECAUTIONARY STATEMENTS AND DIRECTIONS, AND WITH APPLICABLE STATE AND FEDERAL REGULATIONS. Only for fonnutation into a herbicide for the following uses: 

### TERRESTRIALFOOD CROP Acerola (West Indies cherry), apricot, asparagus, avocado, banana, blackberry, blueberry, boysenberry, broccoli, cabbage, Chinese, carrot (including tops), cauliflower, cherry, cocoa, coffee, collards, cucumber, eggplant, fig, filbert (hazelnut), garlic, groundcherry (strawberry tomato/tomatillo), guava, hops, kiwifruit, lettuce, loquat, macadamia nut (bushnut), manioc (cassava), melons, melons, cantaloupe, melons, musk, melons, water, mint, nectarine, olive, onion, papaya, passion fruit, peach, pear, pecan, pepino (melonpear), pepper, pepper (chilli type), pineapple, pistachio, plum, potato, whit/Irish, prune, pumpkin, raspberry (black, red), rhubarb, small fruits, squash (all or unspecified), strawberry, sugarbeet, taro, walnut (English/black), yarn, yautia. 

### TERRESTRIAL FOOD+FEED CROP Almond, apple, barley, beans, asparagus, beans, dried-type, beans, mung; beans-succulent (lima); beanssucculent (snap), citrus fruits, com (unspecified), com, field, com, pop, com, sweet, cotton (unspecified), garbanzos (including chickpeas), grapes, guar, hops, legume vegetables, mint, oats, orchards (unspecified), peanuts, peanuts (unspecified), soybeans, edible, speannint, sugar beet, sugar crops, sugarcane, sunflower, tomato, turnip, vegetables (unspecified), wheat. 

### TERRESTRIAL FEED CROP Alfalfa, barley, beans, clover, crownvetch, legume vegetables, lespedeza, lupine, pastures, sainfoin, timothy, trefoil, tyfon, vetch, wheat. 

### TERRESTRIALNON-FOOD CROP Agricultural fallow/idleland, airports/landing fields, commercial/industrial lawns, commercial/institutionallindustrial, premises/equipment (outdoor), fencecrows/hedgerows, grasses grown for seed, industrial areas (outdoor), jojoba, nonagricultural outdoor buildings/structures, nonagricultural uncultivated areas/soils, ornamental and/or shade trees, peach (non-bearing, seed beds), recreation area lawns, tomato (post-harvest)/ wood protection treatment to forest products (seasoned). 

### FORESTRY Forestplanting (reforestation programs), pine (forest/shelterbelt), shelterbeltplantings

.



### .TERRESTRIAL NON-FOOD

Ornamental andlor shade trees, ornamental herbaceous plants, ornamental woody shrubs and vines, noncrop areas such as public airports, electric transfonner stations and around commercial buildings. 

### OTHERS Uses for which USEPA has accepted the required data andlor citations ofdata that the fonnulator has submitted in support of registration; and uses for experimental purposes that are in compliance with USEPA requirements. 

### STORAGEAND DISPOSAL Do not contaminate water, food or feed by storage, disposal orcleaning ofequipment. PESTICIDE STORAGE; Sotre ate**t~l'llperatures** 

### above 32° F. Do notc:;ontaminate food, foodstuffs, or

4

### drinking Water. Do not store next to feed or food, or transport in or on vehicles containing foodstuffs or feeds. For help with any spill, leak, fire or exposure involving this material call CHEMTREC 1-800-424-9300. PESTICIDE DISPOSAL; Pesticide wastes are acutly hazardous. Improper disposal ofexcess pesticide or rinsate is a violation ofFederal law. Ifthese wastes cannot be disposed of by use according to label instructions, contact your State Pesticide or Enviromental Control Agency, or the Hazardous Waste representative at the nearest EPA Regional Office for guidance. CONTAINER DISPOSAL: Triple rinse (or equivalent). Offer for recycling or recondition, or puncture and dispose of in a sanitary landfill, or dispose of by other procedures allowed by State and local authorities. CONDITIONS OFSALE AND LIMITATION OFWARRANTY AND LIABILITY NOTICE: Read the entire Directions for Use and Conditions of Sale and Limitation ofWarranty and Liability before buying or using this product. Ifthe terms are not acceptable, return the product at once, unopened, and the purchase price will be refunded. The Directions for Use ofthis product should be followed carefully. It 

### is impossible to eliminate all risks inherently associated with the use of this product. Crop injury, ineffectiveness or other unintended consequences may result because of such factors as manner of use or application, weather or crop conditions, presence ofother materials or other influencing factors in the use ofthe product, which are beyond the control ofHelm Agro US, Inc. or Seller. All such risks shall be assumed by Buyer and User, and Buyer and User agree to hold Helm and Seller harmless for any claims relating to such factors. Helm warrants that this product conforms to the chemical description on the label and is reasonably fit for the purposes stated in the Directions for Use, subject to the inherent risks referred to above, when used in accordance with directions under normal use conditions. This warranty does not extend to the use ofthis product contrary to label instructions, or under abnormal conditions or under conditions not reasonably foreseeable to or beyond the control ofSeller or Helm, and Buyer and User assume the risk ofany such use. HELM MAKES NO WARRANTIES OF MERCHANTABILITY OR OF FITNESS FOR A PARTICULAR PURPOSE NOR ANY OTHER EXPRESS OR IMPLIED WARRANTY EXCEPT AS STATED ABOVE. In no event shall Helm or Seller be liable for any incidental, consequential or special damages resulting from the use or handling ofthis product. THE EXCLUSIVE REMEDY OFTHEUSER ORBUYER, AND THE EXCLUSIVE LIABILITY OF HELM AND SELLER FOR ANY AND ALL CLAIMS, LOSSES, INJURIES OR DAMAGES (INCLUDING CLAIMS BASED ON BREACH OF WARRANTY, CONTRACT, NEGLIGENCE, TORT, STRICT LIABILITY OR OTHERWISE) RESULTING FROM THE USE OR HANDLING OF TIDS PRODUCT, SHALL BE THE RETURN OF THE PURCHASE PRICE OF THE PRODUCT OR, AT THE ELECTION OF HELM ORSELLER,THEREPLACEMENT OFTHE PRODUCT. Helm and Seller offer this product, and Buyer and User accept it, subject to the foregoing conditions of sale and limitations ofwarranty and ofliability, which may not be modified except by written agreement signed by a duly authorized representative ofHelm.

5

## Paraquat TC (Technical Concentrate) For Formulation ofParaquatHerbicide Products Only ACTIVE INGREDIENT Paraquatdichloride (1,1'-demethyl, 4,4'-bipyridinium dichloride) INERT INGREDIENTS TOTAL Contains 3 pounds paraquatcation per gallon. Contains emetic. EPAReg. No. 74530-xx EPAEstablishmentNo. 

## KEEP OUT OF REACH OF CHILDREN DANGERJPELIGRO POISON 43.8% 56.2% 100.0%

Si usted no entiende la etiqueta, busque a alguien para que se la explique a usted en detalle. (Ifyou do not understand the label, find someone to explain it to you in detail). 

### • NEVERPUTJNTO FOOD,DRJNK OR OTHER CONTAINERS • IF SWALLOWED, TAKE IMMEDIATE ACTION AS PRESCRIBED IN FIRST AID 

### STATEMENT.SYMPTOMSARE PROLONGED AND PAINFUL. NetContents:



### HELM AGRO Inc. 8295 TournamentDrive Memphis, TN, 38125 info@helmagro.com DRAFT submittedto EPA: 04-j(P2U08

1

### FIRST AID Ifswallowed 

# • Speed is essential. Immediate attention is required. Ifavailable, Give an adsorbent such as activated charcoal, bentonite or Fuller's Earth. 

# • Call a poison control centeror doctor immediately for treatment. 

# • Do not give anything bymouth to an unconscious person. Ifineyes 

# • Hold eye open and rinse slowly and gently with water for 15 to 20 mins. Remove contact lenses, ifpresent, after the first 5 minutes, then continue rinsing eye. 

# • Call a poison control centeror doctor for treatment advice. Ifon skin orclothing 

# • Take offcontaminated clothing. 

# • Rinse skinimmediatelywith plenty ofwater for 15 to 20 minutes. 

## • Call poison control center or doctorfortreatment advice. Ifinhaled 

# • Move personto fresh air. 

# • Ifperson is notbreathing, call 911 or an ambulance. 

# • Call a poison control centerordoctor for furthertreatment advice. 

### NOTE TO PHYSICIAN Administer either activated charcoal (lOOg for adults or 2g1kg body weight in children) or Fuller's Earth (15% solution: 1 literfor adults or 15mglkgbodywight in children(. NOTe: The use of gastric lavage without administration of an adsorbent has not shown any clinical benefit. Do not use supplemental oxygen. Eye splashesfrom concentrated material should be treated by an eye specialist after initial treatment. With the possibilityoflate onset corneal ulceration, 

### itis advised that patients withparaquateye injuries are reviewed by an eye specialist the day after first presentation. Use treatment that is appropriate for chemical burns. Intact skin is an effective barrier to paraquat, however contact with irritated or cut skin orrepeated contactwith intact skin may result in poisoning. Have the pofuct container or label with you when calling apoison control center or doctor, or going for treatment. 

### HOTLINE For medical emergencies involving this product, call CHEMTREC 1-800-424-9300. emergency: Spill, leak, fire, exposure, or accident, call CHEMTREC 1-800-424-9300 

## PRECAUTIONARY STATEMENTS HAZARDS TO HUMANS AND DOMESTICANIMALS DANGERIPELIGRO POISON For chemical

May be fatal ifswallowed. Fatal ifinhaled. Do not breathe spray mist. Do not inhale contaminated dust. Causes substantial but temporary eye injury. Do not get in eyes or on clothing. Avoid contact with skin. Hannful ifabsorbedthrough skin. Wear (goggles, face shield, or safetyglasses). IMPORT ANT: The effect ofswallowingparaquat concentrate is far more severethanthat which usually results from skin contact or inhalation ofcontaminated plant dust. This product should not cause injury if used accordingto label instructions. When handling ormixing concentrate orwhen exposureto concentrate is possible, wear:

2

### • Dust/mistfiltering NIOSH approved respiratorwith any R,P orHE filter • Protective clothing (disposable suit/coveralls orlong-sleeve shirt and long pants) • Full face shield • Chemical-resistant gloves (CategoryA) • Chemical resistant apron and shoes plus socks Wash hands before eating, drinking, chewing gum, using tobacco orusingthe toilet. 

### REMOVE contaminated clothing and wash separatelyfrom other laundry before reuse. 

### ENVIRONMENTAL HAZARDS This product is toxic to wildlife. Do not discharge effluent containing this product into lakes, streams, ponds, estuaries, oceans, or public waters unless this product is specifically identified and addressed in a National Pollutant Discharge Elimination System (NPDES) permit. Do not discharge effluent containing this product to sewer systems without previously notifying the sewage treatment plant authority. For guidance, contactyour State WaterBoard orRegional Office ofEPA. 

### PHYSICAL AND CHEMICAL HAZARD This product reacts with aluminum to produce hydrogen gas which may form a highly combustible gas mixture. Do not mix or store in containers, tanks, or such systems made ofaluminum or having aluminum fittings. 

### EQUIPMENT/CONTAINER Flush all equipment with water after use each day. Paraquat is corrosive to aluminum. Aluminum equipment and aluminum structures that are exposed to solution or spillage should be flushed thoroughly with water immediately after use. 

### SPILLAGE DURING TRANSPORT 

### Emergency Action: Notify police and fire departments immediately. For any spill, leak, fire, or exposure in the United States, call CHEMTREC 1-800-424-9300. KEEP PUBLIC AND ANIMALS awayfrom area. MARK ROADS AND WARN OTHERROAD USERS. WEAR face shield, waterproffgloves, waterprooffootwear, and long-sleeve shirt and longpants during decontamination operations. Clean up spills as soon as possible. Cover spill with generous amount of clay or loam soil to absorb liquid, using a stiffbroom to ensure intimate contact. Sweep onto shovel and transfer to plastic bag or other disposable container. Repeat operations until contaminated surfaces are dry. Finally, hose spill site withwater, iffeasible. 

### DIRECTIONS FOR USE It is a violation ofFederalLawto use this product in a manner inconsistent with its labeling.



### 3

### READ ENTIRE LABEL. USE STRICTLY IN ACCORDANCE WITH PRECAUTIONARY STATEMENTS AND DIRECTIONS, AND WITH APPLICABLE STATE AND FEDERAL REGULATIONS. Onlyfor formulation into a herbicide for the following uses: 

### TERRESTRIALFOOD CROP Acerola (West Indies cherry), apricot, asparagus, avocado, banana, blackberry, blueberry, boysenberry, broccoli, cabbage, Chinese, carrot (includingtops), cauliflower, cherry, cocoa, coffee, collards, cucumber, eggplant, fig, filbert (hazelnut), garlic, groundcherry (strawberry tomato/tomatillo), guava, hops, kiwifruit, lettuce, loquat, macadamia nut (bushnut), manioc (cassava), melons, melons, cantaloupe, melons, musk, melons, water, mint, nectarine, olive, onion, papaya, passion fruit, peach, pear, pecan, pepino (melonpear), pepper, pepper (chilli type), pineapple, pistachio, plum, potato, whitlIrish, prune, pumpkin, raspberry (black, red), rhubarb, small fruits, squash (all or unspecified), strawberry, sugar beet, taro, walnut (Englishlblack),yam, yautia. 

### TERRESTRIALFOOD+FEED CROP Almond, apple, barley, beans, asparagus, beans, dried-type, beans, mung; beans-succulent (lima); beanssucculent (snap), citrus fruits, corn (unspecified), corn, field, corn, pop, corn, sweet, cotton (unspecified), garbanzos (including chickpeas), grapes, guar, hops, legume vegetables, mint, oats, orchards (unspecified), peanuts, peanuts (unspecified), soybeans, edible, spearmint, sugarbeet, sugarcrops, sugarcane, sunflower, tomato, turnip, vegetables (unspecified), wheat. 

### TERRESTRIAL FEED CROP Alfalfa, barley, beans, clover, crownvetch, legume vegetables, lespedeza, lupine, pastures, sainfoin, timothy, trefoil, tyfon, vetch, wheat. 

### TERRESTRIAL NON-FOOD CROP Agricultural fallow/idleland, airports/landing fields, commercial/industrial lawns, commercial/institutional/industrial, premises/equipment (outdoor), fencecrowslhedgerows, grasses grown for seed, industrial areas (outdoor),jojoba, nonagricultural outdoor buildings/structures, nonagricultural uncultivated areas/soils, ornamental and/or shade trees, peach (non-bearing, seed beds), recreation area lawns, tomato (post-harvest)/woodprotection treatmentto forest products (seasoned). 

### FORESTRY Forestplanting (reforestationprograms), pine (forest/sheiterbelt), shelterbeltplantings. 

### TERRESTRIALNON-FOOD Ornamental and/or shade trees, ornamental herbaceous plants, ornamental woody shrubs and vines, noncrop areas such as public airports, electric transformer stations and around commercial buildings. 

### OTHERS Uses for which USEPA has accepted the required data and/or citations of data that the formulator has submitted in support of registration; and uses for experimental purposes that are in compliance with USEPA requirements. 

### STORAGEAND DISPOSAL Do not contaminate water, food or feed by storage, disposal orcleaning ofequipment. 

### PESTICIDE STORAGE; Sotre ate temperatures above 

### 32° F. Do not contaminate food, foodstuffs, or

4

### drinking Water. Do not store next to feed orfood, ortransport in oron vehicles containing foodstuffs or feeds. For help with any spill, leak, fire or exposure involving this material call CHEMTREC 1-800-424-9300. PESTICIDE DISPOSAL; Pesticide wastes are acutly hazardous. Improper disposal ofexcess pesticide or rinsate is a violation ofFederal law. Ifthese wastes cannot be disposed ofby use according to label instructions, contact your State Pesticide or Enviromental Control Agency, or the Hazardous Waste representative atthe nearestEPA Regional Office for guidance. CONTAINER DISPOSAL: Triple rinse (or equivalent). Offer for recycling or recondition, or puncture and dispose of in a sanitary landfill, or dispose of by other procedures allowed by State and local authorities. CONDITIONS OF SALE AND LIMITATIONOFWARRANTYAND LIABILITY NOTICE: Read the entire Directions for Use and Conditions of Sale and Limitation ofWarranty and Liabilitybefore buyingorusing this product. Ifthe terms are not acceptable, return the productatonce, . unopened, and the purchase price willbe refunded. The Directions for Use ofthis product should be followed carefully. It

### is impossibleto eliminate all risks inherently associated with the use of this product. Crop injury, ineffectiveness or other unintended consequences may result because of such factors as manner of use or application, weather or crop conditions, presence ofother materials or other influencing factors in the use ofthe product, which are beyond the control ofHelm Agro US, Inc. or Seller. All such risks shall be assumed by Buyer and User, and Buyer and User agree to hold Helm and Sellerharmless for any claims relating to such factors. Helm warrants that this product conforms to the chemical description on the label and is reasonably fit for the purposes stated in the Directions for Use, subject to the inherent risks referred to above, when used in accordance with directions under normal use conditions. This warranty does not extend to the use ofthis product contrary to label instructions, or under abnormal conditions or under conditions not reasonably foreseeable to or beyond the control ofSeller or Helm, and Buyer and User assume the risk ofany such use. HELM MAKES NO WARRANTIES OF MERCHANTABILITY OR OF FITNESS FOR A PARTICULAR PURPOSE NOR ANY OTHER EXPRESS OR IMPLIED WARRANTY EXCEPT AS STATEDABOVE. In no event shall Helm or Seller be liable for any incidental, consequential or special damages resulting from the use or handling ofthis product. THE EXCLUSIVE REMEDY OF THE USER ORBUYER, AND THE EXCLUSIVE LIABILITY OF HELM AND SELLER FOR ANY AND ALL CLAIMS, LOSSES, INJURIES OR DAMAGES (INCLUDING CLAIMS BASED ON BREACH OF WARRANTY, CONTRACT, NEGLIGENCE, TORT, STRICT LIABILITY OR OTHERWISE) RESULTING FROM THE USE OR HANDLING OF TIDS PRODUCT, SHALL BE THE RETURN OF THE PURCHASE PRICE OF THE PRODUCT OR, AT THE ELECTION OF HELMORSELLER,THE REPLACEMENT OFTHEPRODUCT. Helm and Seller offer this product, and Buyer and User accept it, subject to the foregoing conditions of sale and limitations ofwarranty and ofliability, which may not be modified except by written agreement signed by a duly authorized representative ofHelm.

5

## Paraquat TC (Technical Concentrate) ForFonnulation ofParaquatHerbicide Products Only ACTIVE INGREDIENT Paraquat dichloride (l,l'-demethyl, 4,4'-bipyridinium dichloride) INERTINGREDIENTS
Contains 

### 3 poundsparaquatcationper gallon. Contains emetic. EPA Reg. No. 74530-xx EPAEstablishment No. 

## KEEP OUT OF REACH OF CHILDREN DANGERIPELIGRO POISON 43.8% 56.2% 100.0%

Si usted no entiende la etiqueta, busque a alguien para que se la explique a usted en detalle. (Ifyou do not understandthe label, find someone to explain 

### it to you 

### in detail). 

### • NEVER PUT INTO FOOD,DRINK OROTHER CONTAlNERS • IF SWALLOWED, TAKE IMMEDIATE ACTION AS PRESCRIBED IN FIRST AID STATEMENT.SYMPTOMS

### ARE PROLONGED AND PAINFUL. Net Contents:



### HELM AGRO Inc. 8295 TournamentDrive Memphis, TN, 38125 info@helmagro.com

1 ; )**l~**

DRAFT submitted

# to EFA: 04-50-200'8

### FIRSTAID Ifswallowed 

# • Speed is essential. Immediate attention is required. Ifavailable, Give an adsorbent such as activated charcoal, bentonite or Fuller's Earth. 

# • Call a poison control centeror doctor immediately for treatment. 

# • Do notgive anythingby mouthto an unconscious person. Ifin eyes 

# • Hold eye open and rinse slowly and gently with water for 15 

### to 20 mins. Remove contact lenses, ifpresent, after the first 5 minutes, then continuerinsing eye. 

# • Call a poison control centerordoctor for treatment advice. Ifon skin orclothing 

# • Take offcontaminated clothing. 

# • Rinse skin immediatelywith plenty ofwater for 15 to 20 minutes. 

# • Call poison control center or doctorfor treatment advice. Ifinhaled 

## • Move person to fresh air. 

# • Ifperson is not breathing, call 911 or an ambulance. 

# • Call a poison control centerordoctor for further treatment advice. 

### NOTE TO PHYSICIAN Administer either activated charcoal (lOOg for adults or 2g1kg body weight in children) or Fuller's Earth (15% solution: 1liter for adults or ISmglkgbody wight in children(. NOTe: The use of gastric lavage without administration of an adsorbent has not shown any clinical benefit. Do not use supplemental oxygen. Eye splashesfrom concentrated material should be treated by an eye specialistafter initial treatment. With the possibility oflate onset corneal ulceration, it is advised that patients with paraquat eye injuries are reviewed by an eye specialistthe day after first presentation. Use treatment that is appropriate for chemical burns. Intact skin is an effective barrier to paraquat, however contactwith irritated or cut skin orrepeatedcontactwith intact skin may result inpoisoning

.

. Have the pofuctcontainerorlabel with you when calling a poisoncontrol centeror doctor, orgoingfor

treatment. 

### HOTLINE For medical emergencies involving this product, call CHEMTREC 1-800-424-9300. emergency: Spill, leak, fire, exposure, or accident, call CHEMTREC 1-800-424-9300 

## PRECAUTIONARY STATEMENTS HAZARDS TO HUMANS AND DOMESTIC ANIMALS DANGERIPELIGRO POISON For chemical

May be fatal ifswallowed. Fatal ifinhaled. Do not breathe spray mist. Do not inhale contaminated dust. Causes substantial but temporary eye injury. Do not get in eyes or on clothing. Avoid contact with skin. Harmful ifabsorbed through skin. Wear (goggles, face shield, or safety glasses). 

### IMPORTANT: The effect ofswallowingparaquat concentrate is far more severe than that which usually results from skin contact orinhalation ofcontaminated plant dust. This product should notcause injury if used according to label instructions. When handling ormixing concentrate or when exposureto concentrate is possible,wear:

2

### • Dust/mist filtering NIOSH approved respirator with any R,P or HEfilter • Protective clothing (disposable suit/coveralls orlong-sleeve shirtand long pants) • Full face shield • Chemical-resistant gloves (CategoryA) • Chemicalresistantapron and shoes plus socks Washhands before eating, drinking, chewing gum, using tobacco orusing the toilet. 

### REMOVE contaminated clothing and wash separatelyfrom other laundry beforereuse. 

### ENVIRONMENTAL HAZARDS This product is toxic to wildlife. Do not discharge effluent containing this product into lakes, streams, ponds, estuaries, oceans, or public waters unless this product is specifically identified and addressed 

### in a National Pollutant Discharge Elimination System (NPDES) permit. Do not discharge effluent containing this product to sewer systems without previously notifying the sewage treatment plant authority. For guidance, contact your State WaterBoard orRegional Office ofEPA. 

### PHYSICAL AND CHEMICAL HAZARD This product reacts with aluminum to produce hydrogen gas which may form a highly combustible gas mixture. Do not mix or store in containers, tanks, or such systems made ofaluminum or having aluminum fittings. 

### EQUIPMENT/CONTAINER Flush all equipment with water after use each day. Paraquat is corrosive to aluminum. Aluminum equipment and aluminum structures that are exposed to solution or spillage should be flushed thoroughly with water immediately after use. 

### SPILLAGE DURING TRANSPORT 

### Emergency Action: Notify police and fire departments immediately. For any spill, leak, fire, or exposure in the United States, call CHEMTREC 1-800-424-9300. KEEP PUBLIC AND ANIMALS away from area. MARKROADS AND WARN OTHERROAD USERS. WEARface shield, waterproffgloves, waterprooffootwear, and long-sleeve shirt and long pants during decontamination operations. Clean up spills as soon as possible. Cover spill with generous amount of clay or loam soil to absorb liquid, using a stiffbroom to ensure intimate contact. Sweep onto shovel and transfer to plastic bag or other disposable container. Repeat operations until contaminated surfaces are dry. 

### Finally, hose spill site with water, iffeasible. 

### DIRECTIONS FOR USE Itis aviolation ofFederalLawto use this product in a manner inconsistent with its labeling.

3

### READ ENTIRE LABEL. USE STRICTLY IN ACCORDANCE WITH PRECAUTIONARY STATEMENTS AND DIRECTIONS, AND WITH APPLICABLE STATE AND FEDERAL REGULATIONS. Onlyfor formulation into a herbicide forthe following uses: 

### TERRESTRIALFOOD CROP Acerola (West Indies cherry), apricot, asparagus, avocado, banana, blackberry, blueberry, boysenberry, broccoli, cabbage, Chinese, carrot (includingtops), cauliflower, cherry, cocoa, coffee, collards, cucumber, eggplant, fig, filbert (hazelnut), garlic, groundcherry (strawberry tomato/tomatillo), guava, hops, kiwifruit, lettuce, loquat, macadamia nut (bushnut), manioc (cassava), melons, melons, cantaloupe, melons, musk, melons, water, mint, nectarine, olive, onion, papaya, passion fruit, peach, pear, pecan, pepino (melonpear), pepper, pepper (chilli type), pineapple, pistachio, plum, potato, whitllrish, prune, pumpkin, raspberry (black, red), rhubarb, small fruits, squash (all or unspecified), strawberry, sugar beet,taro, walnut (Englishlblack), yam, yautia. 

### TERRESTRIALFOOD+FEED CROP Almond, apple, barley, beans, asparagus, beans, dried-type, beans, mung; beans-succulent (lima); beanssucculent (snap), citrus fruits, corn (unspecified), corn, field, corn, pop, corn, sweet, cotton (unspecified), garbanzos (including chickpeas), grapes, guar, hops, legume vegetables, mint, oats, orchards (unspecified), peanuts, peanuts (unspecified), soybeans, edible, spearmint, sugarbeet, sugar crops, sugarcane, sunflower, tomato, turnip, vegetables (unspecified), wheat. 

### TERRESTRIALFEEDCROP Alfalfa, barley, beans, clover, crownvetch, legume vegetables, lespedeza, lupine, pastures, sainfoin, timothy, trefoil, tyfon, vetch, wheat. 

### TERRESTRIALNON-FOOD CROP Agricultural fallow/idleland, airportsllanding fields, commercial/industrial lawns, commercial/institutional/industrial, premises/equipment (outdoor), fencecrowslhedgerows, grasses grown for seed, industrial areas (outdoor), jojoba, nonagricultural outdoor bUildings/structures, nonagricultural uncultivated areas/soils, ornamental and/or shade trees, peach (non-bearing, seed beds), recreation area lawns, tomato (post-harvest)/ wood protectiontreatment to forest products (seasoned). 

### FORESTRY Forestplanting (reforestation programs), pine (forestlshelterbelt), shelterbeltplantings. 

### TERRESTRIAL NON-FOOD Ornamental and/or shade trees, ornamental herbaceous plants, ornamental woody shrubs and vines, noncrop areas such as public airports, electric transformer stations and around commercialbuildings. 

### OTHERS Uses for which USEPA has accepted the required data and/or citations of data that the formulator has submitted in support of registration; and uses for experimental purposes that are in compliance with USEPA requirements. 

### STORAGEAND DISPOSAL Do not contaminate water, food orfeed by storage, disposal orcleaning ofequipment. 

### PESTICIDE STORAGE; Sotre ate temperatures above 

### 32' F. Do not contaminate food, foodstuffs, or

4

### drinking Water. Do not store next to feed orfood, ortransport in or on vehicles containingfoodstuffs orfeeds. For help with any spill, leak, fire or exposure involvingthis material call CHEMTREC 1-800-424-9300. 

### PESTICIDE DISPOSAL; Pesticide wastes are acutly hazardous. Improper disposal ofexcess pesticide or rinsate is a violation ofFederal law. Ifthese wastes cannot be disposed ofby use according to label instructions, contact your State Pesticide or Enviromental Control Agency, or the Hazardous Waste representative at the nearestEPA Regional Office for guidance.

'I' 

### CONTAINER DISPOSAL: Triple rinse (or equivalent). Offer for recycling or recondition, orpuncture

and dispose of in a sanitary landfill, or dispose of by other procedures allowed by State and local

, authorities. 

### CONDITIONS OF SALE AND LIMITATION OFWARRANTY AND LIABILITY NOTICE: Read the entire Directions for Use and Conditions ofSale and Limitation ofWarranty and Liabilitybefore buying orusingthis product. Iftheterms are not acceptable, return the product at once, unopened, andthe purchase price will be refunded. The Directions for Use ofthis product should be followed carefully. It

### is impossible to eliminate all risks inherently associated with the use of this product. Crop injury, ineffectiveness or other unintended consequences may result because of such factors as manner of use or application, weather or crop conditions, presence ofother materials or other influencing factors in the use ofthe product, which are beyond the control ofHelm Agro US, Inc. or Seller. All such risks shall be assumed by Buyer and User, and BuyerandUser agree to hold Helm and Seller harmless for any claims relatingto such factors. Helm warrants that this product conforms tothe chemical description on the label and is reasonably fit for the purposes stated in the Directions for Use, subject to the inherent risks referred to above, when used in accordance with directions under normal use conditions. This warranty does not extend tothe use ofthis product contrary to label instructions, or under abnormal conditions or under conditions not reasonably foreseeable to or beyond the control ofSeller or Helm, and Buyer and User assume the risk ofany such use. 

### HELM MAKES NO WARRANTIES OF MERCHANTABILITY OR OF FITNESS FOR A PARTICULAR PURPOSE NOR ANY OTHEREXPRESS OR IMPLIED WARRANTY EXCEPT AS STATED ABOVE. In no event shall Helm or Seller be liable for any incidental, consequential or special damagesresulting from the use or handling ofthis product. 

### THE EXCLUSIVE REMEDY OFTHE USER ORBUYER, AND THE EXCLUSIVE LIABILITY OFHELM AND SELLER FOR ANY AND ALL CLAIMS, LOSSES, INJURIES OR DAMAGES (INCLUDING CLAIMS BASED ON BREACH OF WARRANTY, CONTRACT, NEGLIGENCE, TORT, STRICT LIABILITY OR OTHERWISE) RESULTING FROM THE USE OR HANDLING OF TIDS PRODUCT, SHALL BE THE RETURN OF THE PURCHASE PRICE OF THE PRODUCT OR, AT THE ELECTION OF HELMORSELLER,THEREPLACEMENT OFTHE PRODUCT. Helm and Seller offer this product, and Buyer and User accept it, subject to the foregoing conditions of sale and limitations ofwarranty and ofliability, which may not be modified except by written agreement signed by a duly authorized representative ofHelm.

5

## Paraquat TC (Technical Concentrate) ForFonnulationofParaquatHerbicide Products Only 

### ACTIVE INGREDIENT Paraquat dichloride (1,1 '-demethyl, 4,4'-bipyridinium dichloride) INERTINGREDIENTS TOTAL Contains 3 poundsparaquatcationper gallon. Contains emetic. EPA Reg. No. 74530-xx EPAEstablishmentNo. 

## KEEP OUT OF REACH OF CHILDREN DANGERIPELIGRO POISON 43.8% 56.2% 100.0%

Si usted no entiende laetiqueta, busque a alguien paraque se la explique a usted en detalle. (Ifyou do not understand the label, find someone to explain it to you in detail). 

### • NEVERPUTINTO FOOD,DRINKOROTHER CONTAINERS • IF SWALLOWED, TAKE lMMEDIATE ACTION AS PRESCRIBED 

### IN FIRST AID 

### STATEMENT.SYMPTOMSARE PROLONGED AND PAINFUL. NetContents:

HELM AGRO Inc. 8295 TournamentDrive Memphis, TN, 38125 info@helmagro.com

1 ) DRAFTsubmittedto ¥:PA,: 04-30-2008 ,

### FIRST AID Ifswallowed 

# • Speedis essential. Immediate attention is required. Ifavailable, Give an adsorbent such as activated charcoal, bentonite or Fuller's Earth. 

# • Call a poison control centerordoctor immediately for treatment. 

# • Do not give anything by mouth to an unconscious person. Ifin eyes 

# • Hold eye open and rinse slowly and gently with water for 15 to 20 mins. Remove contact lenses, ifpresent, after the first 5 minutes, then continuerinsing eye. 

# • Call a poison control centerordoctor for treatment advice. 

### Ifon skin orclothing 

# • Take offcontaminated clothing. 

# • Rinse skin immediatelywith plentyofwater for 15 to 20 minutes. 

# • Call poison control center or doctorfor treatment advice. Ifinhaled 

# • Move person to fresh air. 

# • Ifperson is notbreathing, call 911 or an ambulance. 

# • Call a poison control centeror doctor for further treatment advice. 

### NOTE TO PHYSICIAN Administer either activated charcoal (100g for adults or 2g1kg body weight in children) or Fuller's Earth (15% solution: I liter for adults or 15mg/kgbody wight in children(. NOTe: The use ofgastric lavage without administration of an adsorbent has not shown any clinical benefit. Do not use supplemental oxygen. Eye splashesfrom concentrated material should betreated by an eye specialist after initial treatment. With the possibility oflate onset corneal ulceration, it is advised that patients with paraquat eye injuries are reviewed by an eye specialist the day after first presentation

. •Use treatment that is appropriate for chemical bums. Intact skin is an effective barrier to paraquat,

however contactwith irritated orcut skin orrepeatedcontact with intact skin may result in poisoning. Havethe pofuct container or label with you when calling a poison control center ordoctor, orgoing for treatment. 

### HOTLINE For medical emergencies involving this product, call CHEMTREC 1-800-424-9300. For chemical emergency: Spill, leak, fire, exposure, or accident, call CHEMTREC 1-800-424-9300 

## PRECAUTIONARY STATEMENTS HAZARDS TO HUMANS AND DOMESTIC ANIMALS DANGERIPELIGRO POISON May 

### be fatal ifswallowed. Fatal ifinhaled. Do not breathe spray mist. Do not inhale contaminated dust. Causes substantial but temporary eye injury. Do not get in eyes or on clothing. Avoid contact with skin. Harmful ifabsorbed through skin. Wear (goggles, face shield, or safety glasses). IMPORTANT: 

### The effect ofswallowing paraquat concentrate is far more severethan that which usually results from skin contact or inhalation ofcontaminated plant dust. This product should not cause injury if used according to label instructions. Whenhandling ormixing concentrate or when exposureto concentrate is possible, wear:



### 2

### • Dust/mistfiltering NIOSH approved respirator with anyR,P orHE filter • Protective clothing (disposable suit/coveralls or long-sleeve shirtand longpants) • Full face shield • Chemical-resistant gloves (CategoryA) • Chemical resistant apron and shoes plus socks Wash hands before eating, drinking, chewing gum, using tobacco orusingthe toilet. 

### REMOVE contaminated clothing and wash separatelyfrom other laundry before reuse. 

### ENVIRONMENTAL HAZARDS This product is toxic to wildlife. Do not discharge effluent containing this product into lakes, streams, ponds, estuaries, oceans, or public waters unless this product is specifically identified and addressed in a National Pollutant Discharge Elimination System (NPDES) permit. Do not discharge effluent containing this product to sewer systems without previously notifying the sewage treatment plant authority. For guidance, contactyour State WaterBoard orRegional Office ofEPA. 

### PHYSICAL AND CHEMICAL HAZARD This product reacts with aluminum to produce hydrogen gas which may form a highly combustible gas mixture. Do not mix or store in containers, tanks, or such systems made ofaluminum or having aluminum fittings. 

### EQUIPMENT/CONTAINER Flush all equipment with water after use each day. Paraquat is corrosive to aluminum. Aluminum equipment and aluminum structures that are exposed to solution or spillage should be flushed thoroughly with water immediately after use. 

### SPILLAGE DURING TRANSPORT Emergency Action: Notify police and fire departments immediately. For any spill, leak, fire, or exposure in theUnited States, call CHEMTREC 1-800-424-9300. KEEP PUBLIC AND ANIMALS awayfrom area. MARKROADS AND WARN OTHERROAD USERS. WEAR face shield, waterproffgloves, waterprooffootwear, and long-sleeve shirtand longpants during decontamination operations. Clean up spills as soon as possible. Cover spill with generous amount of clay or loam soil to absorb liquid, using a stiffbroom to ensure intimate contact. Sweep onto shovel and transfer to plastic bag or other disposable container. Repeat operations until contaminated surfaces are dry. Finally, hose spill site withwater, iffeasible. 

### DIRECTIONS FOR USE It

### is a violation ofFederal Lawto use this product in a manner inconsistent with its labeling. 

# ( 3

### READ ENTIRE LABEL. USE STRICTLY IN ACCORDANCE WITH PRECAUTIONARY STATEMENTS AND DIRECTIONS, AND WITH APPLICABLE STATE AND FEDERAL REGULATIONS. Only for formulation into aherbicide for the following uses: 

### TERRESTRIAL FOOD CROP Acerola (West Indies cherry), apricot, asparagus, avocado, banana, blackberry, blueberry, boysenberry, broccoli, cabbage, Chinese, carrot (including tops), cauliflower, cherry, cocoa, coffee, collards, cucumber, eggplant, fig, filbert (hazelnut), garlic, groundcherry (strawberry tomato/tomatillo), guava, hops, kiwifruit, lettuce, loquat, macadamia nut (bushnut), manioc (cassava), melons, melons, cantaloupe, melons, musk, melons, water, mint, nectarine, olive, onion, papaya, passion fruit, peach, pear, pecan, pepino (melonpear), pepper, pepper (chillitype), pineapple, pistachio, plum, potato, whitlIrish, prune, pumpkin, raspberry (black, red), rhubarb, small fruits, squash (all or unspecified), strawberry, sugar beet, taro, walnut (Englishlblack), yam, yautia. 

### TERRESTRIAL FOOD+FEED CROP Almond, apple, barley, beans, asparagus, beans, dried-type, beans, mung; beans-succulent (lima); beanssucculent (snap), citrus fruits, corn (unspecified), corn, field, corn, pop, corn, sweet, cotton (unspecified), garbanzos (including chickpeas), grapes, guar, hops, legume vegetables, mint, oats, orchards (unspecified), peanuts, peanuts (unspecified), soybeans, edible, spearmint, sugar beet, sugar crops, sugarcane, sunflower, tomato, turnip, vegetables (unspecified), wheat. 

### TERRESTRIAL FEED CROP Alfalfa, barley, beans, clover, crownvetch, legume vegetables, lespedeza, lupine, pastures, sainfoin, timothy, trefoil, tyfon, vetch, wheat. 

### TERRESTRIAL NON-FOOD CROP Agricultural fallow/idleland, airportsllanding fields, commercial/industrial lawns, commercial/institutional/industrial, premises!equipment (outdoor), fencecrowslhedgerows, grasses grown for seed, industrial areas (outdoor), jojoba, nonagricultural outdoor buildings/structures, nonagricultural uncultivated areas/soils, ornamental and/or shade trees, peach (non-bearing, seed beds), recreation area lawns, tomato (post-harvest)/wood protectiontreatmentto forest products (seasoned). 

### FORESTRY Forestplanting (reforestation programs), pine (forest/shelterbelt), shelterbelt plantings. 

### TERRESTRIAL NON-FOOD Ornamental and/or shade trees, ornamental herbaceous plants, ornamental woody shrubs and vines, noncrop areas such as public airports, electric transformer stations and around commercial buildings. 

### OTHERS Uses for which USEPA has accepted the required data and/or citations ofdata that the formulator has submitted in support of registration; and uses for experimental purposes that are in compliance with USEPA requirements. 

### STORAGEAND DISPOSAL Do not contaminatewater, food or feed by storage, disposal or cleaningofequipment. 

### PESTICIDE STORAGE; Sotre ate temperatures above 32' F. Do not contaminate food, foodstuffs, or

4

### drinking Water. Do not store next to feed or food, ortransport 

### in or on vehicles containingfoodstuffs orfeeds. For help with any spill, leak, fire or exposure involving this material call CHEMTREC 1-800-424-9300. PESTICIDE DISPOSAL; Pesticide wastes are acutly hazardous. Improper disposal ofexcess pesticide or rinsate is a violation ofFederal law. Ifthese wastes cannot be disposed ofby use according to label instructions, contact your State Pesticide or Enviromental Control Agency, or the Hazardous Waste representative at the nearest EPARegional Office for guidance. CONTAINER DISPOSAL: Triple rinse (or equivalent). Offer for recycling orrecondition, orpuncture and dispose of in a sanitary landfill, or dispose of by other procedures allowed by State and local authorities. CONDITIONS OF SALE AND LIMITATION OF WARRANTYAND LIABILITY NOTICE: Read the entire Directions for Use and Conditions of Sale and Limitation ofWarranty and Liability before buying orusing this product. lfthetenns are not acceptable, return the product at once, unopened, and thepurchaseprice will be refunded. The Directions for Use ofthis product should be followed carefully. It is impossible to eliminate all risks inherently associated with the use of this product. Crop injury, ineffectiveness or other unintended consequences may result because of such factors as manner of use or application, weather or crop conditions, presence ofother materials or other influencing factors in the use ofthe product, which are beyond the control ofHelm Agro US, Inc. or Seller. All such risks shall be assumed by Buyer and User, and Buyer and User agree to 

### hold Helm and Sellerharmless for any claimsrelating to such factors. Helm warrants that this product confonns to the chemical description on the label and is reasonably fit for the purposes stated in the Directions for Use, subject to the inherent risks referred.to above, when used 

### in accordance with directions under nonnal use conditions. This warranty does not extend to the use ofthis product contrary to label instructions, or under abnonnal conditions or under conditions not reasonably foreseeable to or beyond the control ofSeller orHelm, and Buyer and User assume the risk ofany such use. HELM MAKES NO WARRANTIES OF MERCHANTABILITY OR OF FITNESS FOR A PARTICULAR PURPOSE NOR ANY OTHER EXPRESS ORIMPLIED WARRANTY EXCEPT AS STATED ABOVE. In no event shall Helm or Seller be liable for any incidental, consequential or special damages reSUlting from the use or handling ofthis product. THE EXCLUSIVE REMEDY OF THE USER ORBUYER, AND THE EXCLUSIVE LIABILITY OF HELM AND SELLER FOR ANY AND ALL CLAIMS, LOSSES, INJURIES OR DAMAGES (INCLUDING CLAIMS BASED ON BREACH OF WARRANTY, CONTRACT, NEGLIGENCE, TORT, STRICT LIABILITY OR OTHERWISE) RESULTING FROM THE USE OR HANDLING OF TIDS PRODUCT, SHALL BE THE RETURN OF THE PURCHASE PRICE OF THE PRODUCT OR, AT THE ELECTION OF HELM OR SELLER, THE REPLACEMENT OF THE PRODUCT. Helm and Seller offer this product, and Buyer and User accept it, subject to the foregoing conditions of sale and limitations ofwarranty and ofliability, which may not be modified except by written agreement signed by a duly authorizedrepresentative ofHelm.

5

## Paraquat TC (Technical Concentrate) ForFonnulationofParaquatHerbicide Products Only 

### ACTIVE INGREDIENT Paraquat dichloride (1,1'-demethyl, 4,4'-bipyridinium dichloride) INERT INGREDIENTS TOTAL Contains 3

### pounds paraquat cation per gallon. Contains emetic. EPA Reg. No. 74530-xx EPA EstablishmentNo. 

## KEEP OUT OF REACH OF CHILDREN DANGERIPELIGRO POISON 43.8% 56.2% 100.0%

Si ustedno entiende la etiqueta, busque a alguienpara que se la explique a usted en 

### detalle. (If

### you do not understand the label, find someone to explain itto you in detail). • NEVERPUT INTO FOOD, DRINK OR OTHER CONTAINERS • IF SWALLOWED, TAKE IMMEDIATE ACTION AS PRESCRIBED IN FIRST AID 

### STATEMENT.SYMPTOMSARE PROLONGED AND PAINFUL. 

### Net Contents:



### HELM AGRO Inc. 8295 Tournament Drive Memphis, TN, 38125 info@helmagro.com

1 • 1" ), 

### DRAFT submitted to EPA: 04-3,Or20P8

### FIRST AID Ifswallowed 

# • Speed is essential. Immediate attention is required. Ifavailable, Give an adsorbent such as activated charcoal, bentonite or Fuller's Earth. 

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

# • Do not give anything by mouth to an unconscious person. 

### Ifineyes 

# • Hold eye open and rinse slowly and gently with water for 15 to 20 mins. Remove contact lenses, ifpresent, after the first 5 minutes, then continuerinsing eye. 

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

# • Take offcontaminatedclothing. 

# • Rinse skin immediately with plentyofwaterfor 15 to 20 minutes. 

# • Call poison control centeror doctor for treatment advice. Ifinhaled 

# • Move person to fresh air. 

# • Ifperson is notbreathing, call 911 or an ambulance. 

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

### NOTE TO PHYSICIAN Administer either activated charcoal (lOOg for adults or 2g1kg body weight in children) or Fuller's Earth (15% solution: 1liter for adults or 15mglkgbodywight in children(. NOTe: The use of gastric lavage without administration ofan adsorbent has not shown any clinical benefit. Do not use supplemental oxygen. Eye splashesfrom concentrated material should be treated by an eye specialistafter initial treatment. With the possibility oflate onset corneal ulceration, it is advised thatpatients with paraquat eye injuries are reviewed by an eye specialistthe day after first presentation. Use treatment that is appropriate for chemical burns. Intact skin is an effective barrier to paraquat, however contact with irritated or cut skin orrepeated contact with intact skin may result in poisoning. Have the pofuct container or label with you when calling a poison control centeror doctor, or going for

, treatment. 

### HOTLINE

For medical emergencies involving this product, call CHEMTREC 1-800-424-9300. For chemical
i 

### emergency: Spill, leak, fire, exposure, oraccident, call CHEMTREC 1-800-424-9300



## PRECAUTIONARY STATEMENTS HAZARDS TO HUMANS AND DOMESTIC ANIMALS DANGERIPELIGRO POISON May be fatal ifswallowed. Fatal ifinhaled. Do not breathe spray mist. Do not inhale contaminated dust. Causes substantial but temporary eye injury. Do not get in eyes or on clothing. Avoid contact with skin. Harmful ifabsorbedthrough skin. Wear (goggles, face shield, or safety glasses). 

### IMPORTANT: The effect ofswallowingparaquat concentrate is far more severe than that which usually results from skin contact or inhalation ofcontaminated plant dust. This product should not cause injury if used according to label instructions. Whenhandling ormixing concentrate orwhen exposure to concentrate is possible, wear:

2

### • Dust/mist filtering NIOSH approvedrespirator with any R,P or HE filter • Protective clothing (disposable suit/coveralls orlong-sleeve shirt and long pants) • Full face shield • Chemical-resistant gloves (CategoryA) • Chemical resistant apron and shoes plus socks Wash hands before eating, drinking, chewinggum, usingtobacco orusing the toilet. REMOVE contaminated clothing and wash separatelyfrom other laundry before reuse. 

### ENVIRONMENTAL HAZARDS This product is toxic to wildlife. Do not discharge effluent containing this product into lakes, streams, ponds, estuaries, oceans, or public waters unless this product is specifically identified and addressed in a National Pollutant Discharge Elimination System (NPDES) permit. Do not discharge effluent containing this product to sewer systems without previously notifying the sewage treatment plant authority. For guidance, contact your State WaterBoard orRegional Office ofEPA. 

### PHYSICALAND CHEMICALHAZARD This product reacts with aluminum to produce hydrogen gas which may form a highly combustible gas mixture. Do not mix or store in containers, tanks, or such systems made ofaluminum orhaving aluminum fittings. 

### EQUIPMENT/CONTAINER Flush all equipment with water after use each day. Paraquat is corrosive to aluminum. Aluminum equipment and aluminum structures that are exposed to solution or spillage should be flushed thoroughly with water immediately after use. 

### SPILLAGEDURINGTRANSPORT Emergency Action: Notify police and fITe departments immediately. For any spill, leak, fire, or exposure in the United States, call CHEMTREC 1-800-424-9300. KEEP PUBLIC AND ANIMALS away from area. MARK. ROADS AND WARN OTHERROAD USERS. WEAR face shield, waterproffgloves, waterprooffootwear, and long-sleeve shirt and longpants during decontamination operations. Clean up spills as soon as possible. Cover spill with generous amount of clay or loam soil to absorb liquid, using a stiffbroom to ensure intimate contact. Sweep onto shovel and transfer to plastic bag or other disposable container. Repeat operations until contaminated surfaces are dry. Finally, hose spill site with water, iffeasible. 

### DIRECTIONS 

### FOR USE Itis a violation ofFederal Lawto use this product in a manner inconsistent with its labeling.



### 3

### READ ENTIRE LABEL. USE STRICTLY IN ACCORDANCE WITH PRECAUTIONARY STATEMENTS AND DIRECTIONS, AND WITH APPLICABLE STATE AND FEDERAL REGULATIONS. Only for formulation into a herbicide for the following uses: 

### TERRESTRIAL FOOD CROP Acerola (West Indies cherry), apricot, asparagus, avocado, banana, blackberry, blueberry, boysenberry, broccoli, cabbage, Chinese, carrot (includingtops), cauliflower, cherry, cocoa, coffee, collards, cucumber, eggplant, fig, filbert (hazelnut), garlic, groundcherry (strawberry tomato/tomatillo), guava, hops, kiwifruit, lettuce, loquat, macadamia nut (bushnut), manioc (cassava), melons, melons, cantaloupe, melons, musk, melons, water, mint, nectarine, olive, onion, papaya, passion fruit, peach, pear, pecan, pepino (melonpear), pepper, pepper (chilli type), pineapple, pistachio, plum, potato, whitJIrish, prune, pumpkin, raspberry (black, red), rhubarb, small fruits, squash (all or unspecified), strawberry, sugar beet, taro, walnut (Englishlblack), yam, yautia. 

### TERRESTRIALFOOD+FEED CROP Almond, apple, barley, beans, asparagus, beans,**dried~type,** 

### beans, mung;**beans~succulent** 

### (lima);**beans~** 

### succulent (snap), citrus fruits, com (unspecified), com, field, com, pop, com, sweet, cotton (unspecified), garbanzos (including chickpeas), grapes, guar, hops, legume vegetables, mint, oats, orchards (unspecified), peanuts, peanuts (unspecified), soybeans, edible, spearmint, sugar beet, sugar crops, sugarcane, sunflower, tomato, turnip, vegetables (unspecified), wheat. 

### TERRESTRIALFEED CROP Alfalfa, barley, beans, clover, crownvetch, legume vegetables, lespedeza, lupine, pastures, sainfoin, timothy, trefoil, tyfon, vetch, wheat. 

### TERRESTRIALNON-FOOD CROP Agricultural fallow/idleland, airports/landing fields, commercial/industrial lawns, commercial/institutional/industrial, premises/equipment (outdoor), fencecrowslhedgerows, grasses grown for seed, industrial areas (outdoor), jojoba, nonagricultural outdoor buildings/structures, nonagricultural uncultivated areaS/soils, ornamental and/or shade trees, peach (non-bearing, seed beds), recreation area lawns, tomato (post-harvest)/ wood protection treatment to forest products (seasoned). 

### FORESTRY Forestplanting (reforestation programs), pine (forestlshelterbelt), shelterbelt plantings. 

### TERRESTRIAL NON-FOOD Ornamental and/or shade trees, ornamental herbaceous plants, ornamental woody shrubs and vines,**non~** 

### crop areas such as public airports, electric transformer stations and around commercialbuildings. 

### OTHERS Uses for which USEPA has accepted the required data and/or citations of data that the formulator has submitted in support of registration; and uses for experimental purposes that are in compliance with USEPArequirements. 

### STORAGEAND DISPOSAL Donotcontaminate water, food or feed by storage, disposal orcleaning ofequipment. 

### PESTICIDE STORAGE; Sotre ate temperatures above 

### 32" F. Do not contaminate food, foodstuffs, or .

4drinking Water. Do not store next to feed or food, ortransport in or on vehicles containingfoodstuffs or feeds. For help with any spill, leak, ftre orexposure involving this material call CHEMTREC 1-800-424-9300. 

### PESTICIDE DISPOSAL; Pesticide wastes are acutly hazardous. Improper disposal ofexcess pesticide or rinsate is a violation ofFederal law. Ifthese wastes cannot be disposed ofby use according to label instructions, contact your State Pesticide or Enviromental Control Agency, or the Hazardous Waste representative atthe nearestEPARegional Office for guidance. ' 

### CONTAINER DISPOSAL: Triple rinse (or equivalent). Offer for recycling orrecondition, orpuncture and dispose of in a sanitary landftll, or dispose of by other procedures allowed by State and local authorities. 

### CONDITIONS OF SALE AND LIMITATIONOFWARRANTY AND LIABILITY NOTICE: Read the entire Directions for Use and Conditions of Sale and Limitation ofWarranty an4 Liabilitybefore buying orusing thisproduct. Iftheterms are not acceptable, returnthe product at once, unopened, and the purchase price will be refunded. The Directions for Use ofthis product should be followed carefully. 

### Itis impossibleto eliminate all risks inherently associated with the use of this product. Crop injury, ineffectiveness or other unintended consequences may result because of such factors as manner of use or application, weather or crop conditions, presence of other materials or other influencing factors in the use ofthe product, which are beyond the control ofHelm Agro US, Inc. or Seller. All such risks shall be assumed by Buyer and User, and Buyerand Useragree to hold Helm and Seller harmless for anyclaimsrelatingto such factors. Helmwarrants that this productconforms tothe chemical description on the label and is reasonably ftt for the purposes stated in the Directions for Use, subject to the inherent risks referred to above, when used in accordance with directions under normal use conditions. This warranty does not extend to the use ofthis product contrary to label instructions, or under abnormal conditions or under conditions not reasonably foreseeable to or beyond the control ofSeller or Helm, and Buyer and User assume the risk ofany such use. 

### HELM MAKES NO WARRANTIES OF MERCHANTABILITY OR OF FITNESS FOR A PARTICULAR PURPOSE NOR ANY OTHER EXPRESS OR IMPLIED WARRANTY EXCEPT AS STATED ABOVE. In no event shall Helm or Seller be liable for any incidental, consequential or special damages reSUlting from the use orhandling ofthis product. 

### THE EXCLUSIVE REMEDY OF THE USER OR BUYER, AND THE EXCLUSIVE LIABILITY OF HELM AND SELLER FOR ANY AND ALL CLAIMS, LOSSES, INJURIES OR DAMAGES (INCLUDING CLAIMS BASED ON BREACH OF WARRANTY, CONTRACT, NEGLIGENCE, TORT, STRICT LIABILITY OR OTHERWISE) RESULTING FROM THE USE OR HANDLING OF THIS PRODUCT, SHALL BE THE RETURN OF THE PURCHASE PRICE OF THE PRODUCT OR, AT THE ELECTION OF HELM OR SELLER, THE REPLACEMENT OF THE PRODUCT. Helm and Seller offer this product, and Buyer and User accept it, subject to the foregoing conditions of sale and limitations ofwarranty and ofliability, which may not be modifted except by written agreement signed by a duly authorizedrepresentative ofHelm.

5

### EPA stration File 75430-37 Page not included in this copy. Pages 187 through 196 are not included in this copy. The material not included contains the following type of information: 

# x Identity product ingredients. Ident of product impurities. Description of the product manufacturing process. Description of quality control procedures. X Identity of the source of product ingredients. Sales or other commercial/financial information. A draft product label. The product confidential statement of formula.

Information about a pending registration action. FIFRA stration data. The document is a duplicate of page(s) The document is not responsive to the request. Internal deliberative information.**~~~-** 

### Attorney-Client work product. Claimed Confidential by submitter upon submission to the Agency. Personal Privacy Information The information not included is generally considered confidential by product registrants. If you have any questions, please contact the individual who prepared the response to your request.lOR FORM 9·11 MARCH 2006)

# ~(IDw**lID~~~~~ffi~**

# ~rn**~~~** FILE SYMBOL

# 7Jf'r30-&r REGISTRATION NO. 

# CONFIDENTIAL STATEMENT OF FORMULA ENCLOSED

DATE SUBMITTED BY (v') 

### SUBMITTED APPLICANT BASIC SUPPLIER 

# MAY 02 

# 200B

-- 

## Do Not Write Comments, Formula, or Parts of Formula on This Envelope

NOTE It shall be unlawful-for any person to use for his own advantage or to reveal, other than to the Secretary, or officials or employees of the United States Department of Agriculture or other Federal agencies, or to the courts In response to a subpoena, or to phYSicians, and In emergencies to pharmacists and other qualified persons, for use in the preparation of antidotes, In accordance with such directions as the Secretary may prescribe, any Information relative to formulas of products acquired by authority of Section 4 of the "Federal InsectiCide, fungicide, and Rodenticide Act."

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### Electronic Code ofFederal Regulations: Page 1of22

Home Page> Executive Branch> Gode of Federal Regulations> Electronic Code of Federal Regulations



## lations



## e-CFR Data is current as of May 5, 2008
Title 40: 

### Protection of Environment PART 18Q-TOLERANCES AND EXEMPTIONS FROM TOLERANCES FOR PESTICIDE CHEMICALS IN FOOD Subpart D-Exemptions From Tolerances Browse Previous 

### I Browse Next 

### § 180.910 Inert ingredients used pre- and post-harvest; exemptions from the requirement ofa tolerance. Unkto an amendment published at 71 FR 45421, August 9, 2006. Residues ofthe following materials are exempted from the requirement of a tolerance when used in accordance with good agricultural practice as inert (oroccasionally active) ingredients in pesticide formulations applied to growing crops or to raw agricultural commodities after harvest: 

## Inert ingredients Limits Uses 

## Acetic acid 

# I Catalyst 

## Acetic anhydride 

## ISOlvent, .cosolvent Acetone 

# I Do. Alkanoic and alkenoic acids, mono- Emulsifiers and diesters of a-hydro-w-hydroxypoly (oxyethylene) with molecular weight (in amu) range of 200 to 6,000 Alkyl (Ca

## -C24) 

## benzenesulfonic acid Surfactants, and its ammonium, calcium, related adjuvants magnesium, potassium, sodium, and of surfactants zinc salts a-Alkyl (C9

## -C1a

## -w,-hydroxypoly Solvent, (oxyethylene) with poly(oxyethylene) cosolvent, content of 2-30 moles surfactant, and related adjuvants of surfactants 

# I I 

# I I

I
http://ecfr.gpoaccess.gov/cgiltltextltext-idx?c=ecfr&sid=ald63734f7d3b0312cb51alb49059... 5/7/2008

### EPA Registration File #75430-37 Page is not included in this copy. Pages 200 through 201 are not included in this copy. The material not included contains the following type of information: 

### X Identity of product inert ingredients. Identity of product impurities. Description of the product manufacturing process. Description of quality control procedures. Identity of the source of product ingredients. Sales or other commercial/financial information. A draft product label. The product confidential statement of formula.

Information about a pending registration action. FIFRA registration data. The document is a duplicate of page(s) The document is not responsive to the request. Internal deliberative information.

-------

### Attorney-Client work product. Claimed Confidential by submitter upon submission to the Agency. Personal Privacy Information The information not included is generally considered confidential by product registrants, If you have any questions, please contact the individual who prepared the response to your request.

### EPA Registration File #75430-37 Page 202 is not included in this copy. Pages through are not included in s copy. The material not included contains the following type of information: 

### Identi of product inert ty of product impuri Description of the product manufacturing process. Des ion of quality control procedures. ty of the source of product ingredients.
s or other commercial/financ information. A t product label. X The product confidential statement of formula. Information about a pending stration action. FIFRA registration data. document 1S 

### a duplicate page(s) document is not respons to the request. deliberative informat Attorney-Client work product. Claimed Confidential by submitter upon submission to the Agency. Personal Privacy Information The information not included is ly considered confident by product registrants. If you have any questions, please contact the individual who prepared the response to your request.