# EPA Reg istration Number 86461 -2

# nllllllllWllll/illl 

# III 009285062)

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

QPPTSIOPP/RDfTRBfPRODUCT ('> IEMISTRY TEAM
WASHINGTON, D.C. 20460 

### DATE OUT: April 14, 

### 2010

SUBJECT: FEE: Product Chemistry Review of ' Glyph os ate 62% Manufacturing Cone'

FROM: Reg No: 86461-E Barcode 

### #: 373485 Decision 

### #: 419147 PC Code(s): 

### 417300 

### Food Use: Yes Action Code: R300

Linda 

### L. Kutney, Chemist

## L~ 

# L**~** Product Chemistry Team 

### 't-I,,\""-IO \ (LA-...

# ~p 

# q/lIA/!O

Technical Review BranchIRD (7505P) 

# b '\P

### TO: 

### James Tompkins, Erik Kraft RM-25 Herbicide Branch! RD (7505P)

INTRODUCTION:



### In their letter dated 1-12-10, Biologic Inc, agent for the Registrant, TF Holdings, responded to 

### IRE's previous review (L. 

### Kutney, D369208, 11-27-09), with a revised basic CSF 

### (12-31-09) and alternate CSF 

### (12-31-09) for their new product, Glyphosate 62% Manufacturing Concentrate. The label claim for this product is 62.0% glyphosate IP A salt. There various several food uses proposed for this product.



### The previous basic CSF, dated 8-5-09, was not acceptable and not identical in composition (CSF) to the one having Reg No 83520-6, even though TFHoldings elected the cite-all method of support and received a letter of authorization from Axss -USA to cite product chemistry data to support registration, submitted under Reg No 

### 83520-6. Data cited included MRIDs 

### 47042001, 47042002 and 

### 47509201. A data matrix 

### dated 8-20-09 was also submitted.

SUMMARY OF FINDINGS:

1. 

### The nominal concentration of the 

### ai(s) in the proposed CSF agrees with the label claim (pRN 91-2 is satisfied).

2. All inert components of the 

### CSF are approved for the proposed food use(s).

3. The physical chemical hazard and storage and disposal statements on the label were previously concluded to be appropriate.

### TRB CONCLUSIONS:

1. The basic CSF (dated 12-31-09) is acceptable. It 

### is identical to the accepted basic CSF for the
Axss product, Reg No 83520-6, dated 6-26-07 (l. 

### Gairo1a, 7-31-07, D336486).



### 2. The alternate CSF (dated 12-31-09) is not acceptable and not similar to the cited product, from a product chemistry perspective because 

### it includes toxic impurities. The alternate 

## esp, produced using a different source ai, contains additional impurities of toxicological 

### concern (See Confidential Appendix). 40 CFR 158.325(c) states that all impurities of toxicological 

### concern
must be included on the CSF and 40 CFR 152.43 states that the alternate CSF may not have 

### higher amounts of toxic 

### impurities than the basic CSF.

3. Product chemistry Group A and B data from the cited Reg No 83520-6 are acceptable to support 

### the basic CSF for the proposed product, but not the alternate eSF, 

### containing additional impurities of toxic 

### concern.**~CT· 'DATI~A&**  

### llll

Group A, Requirement 830.- Data MRID



### -:

## ~
1550.Chemical Yes CSF



### 1600. Beginning Materials Yes 470420-01



### 1650. Formulation Process Yes 470420-01



### 1670. Discussion of Yes 470420-01

1750. Certified Limits(CSF) Yes CSF



### 1800 Enforcement Analytical Yes 470420-01 Method

-2-

### GroupE. Guideline 830.-:

6302 Color

630J Physical State

6304 Odor



### 6314 OxidationlReduction

6315 FlammabilitylFlame 

### Extension

6316 Explodability

6317 Storage Stability

6319 Miscibility



### 6320 Corrosion Characteristics

6321 Dielectric Breakdown Voltage

7000 pH



### 7100 Viscosity

7300. DensitylBulk Density 

### Explanations: NA = 

### Not Applicable
From MRID 470420-02 Data
Fulfilled?



### Yes

Yes

Yes

Yes

Yes

Yes

Yes

Yes

Yes

Yes

Yes

Yes

Yes 

### Description MRID

See Table I Below 470420-02

See Table I Below 470420-02

See Table I Below 470420-02



### Contains no strong Data Matrix 

### oxidizing or reducing agents.

NA Solid Does not contain Data Matrix
combustible liquids.

Not reported to contain Data Matrix 

### explosive components.

Study attached, expected to 475092-01 

### be stable for a year.

NA. Does not contain and Label 

### is not mixed 

### with Data Matrix 

### petroleum solvents.

Study attached, expected to 475092-01



### be stable for a year.

Not used around electrical Label equipment. Data Matrix

See Table I Below 470420-02

See Table 1 Below 470420-02

See Table I Below 470420-02

-3-Table 1. Physical and Chemical**P~operties** of IPA GlyphosatQ 62%

Guideline Number Charaetct"istie Value/Observation

830.6302 Color Colorless (Gardner 2), sligh'Cly cloudy

830.6303 Physical State Liquid

830.6304 Odor Mild amine odor

830.7000 p" 4.49 (1:' solution)

830.7100 Viscosity 179 centipoiso 

# " 

# '" e 74.5 centipoise at 

# ", e

830.7300 Density 1.240 g/ce at 

# '" e 1. 230 glcc 

# " 39' e



### -4-

### Storage Stability and Corrosion Characteristics Data (From the cited MRID 475092-01)

This cited study used reverse-phase HPLC to assay initial and post-storage purities ofAxss's Glyphosate manufacturing use concentrate, Reg No 83520-6, according to their method, CHBML SOP CHB-OP-MTH-096-P. Two samples were tested, in triplicate, after 0, 3, 6, 9, 10 and 12 months of storage

at 25C. Container appearance and integrity was evaluated at these times, along with the sample assay.

Container integrity and appearance, and sample purity did not change unacceptably throughout the testing period (see excerpt from MRID 475092-01, below). Weight changes of the stored samples were not significant, throughout the 'test period. Storage stability of the cited product is expected to be acceptable, in HDPE, for up to a year at 25C. These data, however, may not be used to support the unacceptable alternate CSF, due to its toxic impurity contaminants.

Initial

3 Months

6 

### Months

10 

### Months

12 

### Months
Slope of regression line, year
of slope

Critical of t-statistic, 95 % 

### confidence

value of t-statistic. 98 % 

### confidence

Certified Limit

. Uppe"r Certified Limit

-5- 62.53 

# •

61. 98 

# •

62.21 

# ,

61.51 

# •

61. 

# •

1. 249

- 4.357



### ± 3.182

± 4.541**6~.14** %

63.86 

# •

### CONFIDENTIAL APPENDIX:



### The source ai for the alternate CSF for the proposed product contains the following two toxic 

### carcinogenic impurities:

-6-EPA File Symbol 86461-E PC Code 103601 (glyphosate IPA)



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

OFFICE OF PREVENTION, PESTICIDES AND TOXIC SUBSTANCES



### TECHNICAL REVIEW BRANCH SIMILARITY CLINIC DETERMINATION



### 13/0CT/2009

MEMORANDUM



### Subject: Name of Pesticide 

### Product: EPA Reg. No. IFile Symbol: 

### Glyphosate 62% Manufacturing Concentrate 86461-E 

### DP Barcode: D369209 

### Decision No: 419147 

### Action Code: R300 PC Code: 103601 (glyphosate IP A)

.



### From: Eugenia McAndrew, Biologist Technical Review Branch Registration Division (7505P)

To: Erik 

### Kraft. RM Team 25 

### Herbicide Branch Registration Division (7505P)

Applicant: TF Holdings I, LLC P.O. Box 1034 Platte City, MO 64079

FORMULATION FROM LABEL:



### Active IngredientCs): Glyphosate, N-(phosphonomethyl) glycine, in the form of its 

### isopropylamine salt

Inert Ingredient(s):
Total: % 

### bywt.

62.0

38.0 100.0%

ACTION REQUESTED: The Risk Manager requests: "Please determine similarity to 83520-6 

### and precautionary language."

Page I of]EPA File Symho186461-E PC Code 103601 (glyphosate IPA)



### BACKGROUND: TF Holdings I, LLC has applied for registration of GIyphosate 62% Manufacturing Concentrate, EPA File Symbol 86461-E, claiming similarity to Glyphosate 62% Manufacturing Concentrate, EPA Reg. No. 83520-6. The active ingredient in both products is 62.0% glyphosate IPA. The Registrant is using the cite-all method of data support to satisfy the

acute toxicity data requirements.

A search of the OPP electronic databases shows that the cited product, 83520-6, was found to be substantially similar to another registered product in a prior IRB action (McAndrew; D336487; 

### 07/AUG/2007). Therefore, no acute toxicity data were submitted for 83520-6.

RECOMMENDATIONS: TRB has evaluated the formulations of the proposed product, 86461-E, and the cited product, 83520-6, and has determined that the two products are substantially similar.

The acute toxicity profile for the proposed product, Glyphosate 62% Manufacturing Concentrate, EPA File Symbol 86461-E, is as follows:

acute oral toxicity IV cited EPA Reg. No. 83520-6

acute dermal toxicity IV cited EPA Reg. No. 83520-6

acute inhalation toxicity IV cited EPA Reg. No. 83520-6 primary eye irritation IV cited EPA Reg. No. 83520-6 primary skin irritation IV cited EPA Reg. No. 83520-6 dermal sensitization negative cited EPA Reg. No. 83520-6

The proposed basic CSF dated August· 5, 2009 should be approved by the TRB Product Chemistry Team.

This memorandum pertains only to the decision concerning whether the subject product is similar to the cited product from an acute toxicological view point. For the purposes of this action, TRB has made no further determination of the adequacy of the toxicological data base or the precautionary label of the cited product.

LABELING: Based on the toxicity profile above, the following are the precautionary and first aid statements for this product as obtained from the Label Review System:

PRODUCTID #:

PRODUCT NAME:

SIGNAL WORD: 

### (optional) 086461-00002



### Glyphosate 62% Manufacturing Concentrate

PRECAUTIONARY STATEMENTS

CAUTION

Hazards to Humans and Domestic Animals:

Page 2 of3EPA File Symbol 86461-E PC Code 103601 (glyphosate IPA)

Hazards to Humans and Domestic Animals:

First Aid: No statements are required. Category III statements may be used.

Page 3 00

### )

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

QPPTS/OPP/ROrrRBIPROQUCT CHE:MJSTRY TEAM
WASHINGTON, D.C. 20460 DATE OUT: November 27, 2009 

# FEE

SUBJECT: FEE: Product Chemistry Review of 'Glyphosatc 62% Manufacturing Cone' Reg No: 86461-E Barcode 

### #: 369208 Decision 

### #: 419147 PC Coders): 417300 

### Food Use; Yes Action Code: R300

FROM: 

### Linda L. 

### Kutney, Chemist Product Chemistry Team

# ~'-L-~ Technical Review BranchIRD (7505P)

TO: James Tompkins, Erik Kraft RM-25
Herbicide Branch! RD (7505P)

INTRODUCTION: (t _7-7 _0 <"\



### In their letter dated 8

R 

### 25-09, the Registrant, TF Holdings, has submitted a registration request for their new product, Glyphosate 62% Manufacturing Concentrate. The label claim for this product is 62.0% glyphosate IPA salt. There various several food uses proposed for this product. A new basic CSF, dated 8-5

R 

### 09, was proposed.



### The Registrant has claimed their product is identical in composition (CSF) and labeling to the cne having Reg No 83520R6. Although no data were submitted, they have e1ccted the citeRail method of support and have received a letter of authorization from Axss USA to cite product chemistry data to support registration, submitted under Reg No 83520-6, including MRlDs 47042001, 47042002 and 47509201.

SUMMARY OF FINDINGS:



### 1. The nominal concentration of the 

### ai(s) in the proposed CSF agrees with the label claim (PRN 91 R2 is satisfied).

2, All inert components of the 

### CSF are approved for the proposed use(s).

3. The physical chemical hazard and storage and disposal statements on the label are appropriate.

## IRB CONCLUSIONS:

1. The basic CSF (dated 8·5-09) is not acceptable. The CSF must include all impurities of toxicological concern which are present from the starting materials andlor the manufacturing
processes (See 40 CFR 158.325 (c)).

2. The product chemistry of the proposed product is not substantially similar or identical to that of the product having Reg No 83520-6, because the proposed product is produced using a different source ai and contains an additional impurity (or more impurities) oftoxicoiogical concern (See Confidential Appendix), The toxic impurity profiles of the proposed and cited products are not similar, from a product chemistry perspective.

3, Product chemistry Group A and B data from the cited Reg No 83520-6 are not acceptable to support the proposed product because 

### it contains additional impurities of toxic concern. All product chemistry data must be furnished using the proposed MUP.

-2-

### )

CONFIDENTIAL APPENDIX:



### The source ai for the proposed product contains two toxic impurities:

-3-,- 

### -----

.. 

### -

----- .-.._- 

### ----_.,- ._.



## ISB'S Front-end PRlA Completeness Screen
Draft 3; 

### 10/25107

EPA Rcceipt Date: 

## AUG 26 2009 EPA Reg. Number: 

# P6Lf61-t:

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### Has the PRIA Fee been Paid; is a copy of the check or 

# ;\ Pay.gov rcccipt included in the Submission Package?

Is un Application Form (EPA Form 8570·1) Included in the 

# X 2 

### Submission Package, is it completely filled' 

### out and signed including package type?



# - Is a Confidential Statement of Formula (EPA Fonn 8570· 

# x: 3 29) included in the Submission Package, is it completely filled out and signed (boxes 1·21)?

4 

### Is a Formulator's Exemption Statement (EPA Fonn 8570· 

# X 27) Included jn the Submission Package?



## ..
5 Is u Certification with Respect to Citation of Data (EPA 

# X Form 8570·34) Included in the Submission Package?

(, 

### Is a Data Matrix (EPA Fonn 8570·35) Included in the 

# X Submission Package?



# -**~** 7 Is a Label Included in the Submission Package? 

# ;z.

S Arc Data Included in the Submission Package? 

# X

C) 

### ,Is 

### the Submission an Amendment? 

# X Wi..

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### -._._--- --- 

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

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### ------------------) 

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

Reg. No. 7{1o L/ & 1- L



## Description: 

# NeLL) 

# ¥LL

1.

# ~ Placement within the e-Jacket/jacket: 

# !;)! Default: (chronological, top 

# = newest)

o File 

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

## 45")

2. 0 Send to Data Extraction contractors this material: 

# ;a Newly stamped accepted label

o Notification

o NewCSF

o Other:

____________ _

3. Attach this coversheet to the top of the material or jacket. It must be well organized and clipped together, NOT STAPLED. Then give the material with this coversheet to staff in the Information Services Center (Room S-4900).**~** . 

# Reviewer's Name: 

# jitvL IOHf 

# t:IJ'

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# Phone: 30t:, !>&")'7 

# Division: 

# _K_D

__ _
Date:

# ~<~{~fi~O+/I~D ____________________

# ~ ______ _

Created August 14,2008

# rr=============~-============::r;E:p:A~R:,:g. Number: DateofIsslIance:



### u. " NME TAL P LECUUN A "J::NCY

Office ofPesticjde Progmms
Registration Division (7505P)

1200 PennsyiYallia. Ave., N.W.

WashingtOn, D.C. 20460



### NOTICE OF PESTICIDE: X Registration

_ Reregistration

(under FIFRA. as amended)

Name and Address of Registrant (include ZIP Code): 

### 86461-2 

# MAY 7 2010

Term oflssuance:

Name of Pesticide Product: 

### Glyphosate 62% Manufacturing Concentrate

On the basis of infunnation furnished by the registrant, the above named pesticide is hereby registered/reregiStered under the Federal Insecticide, Fungicide and Rodenticide Act.

Registmtion is in no way to be construed as an endorsement or recommendation of this product by the Agency. In orderto protect health and the
environment, the Administrator. on his motion, may at anytime suspend or cancel the registration ofa pesticide in accordance with the Act. The

acceptance ofany name in connection with the registration ofa product under this Act is not to be construed as giving the registrant a right to exclusive

use of the name or to its use if it has been covered by others.



### This product is conditionally registered 

### in accordance 

### with FIFRA provided you agree in 

### writing to:



### 1. The basic csf dated 12/31/09 

### is acceptable. The alternate csfis not acceptable (see chern.
review for explanation).

Signature Date:



### James Herbicide

### Page 2
EPA Reg. 86461-2



### 2. You must list the residential sites on page 3 and you must list roundup ready crops on the label 

### if


### you wish to use this product to be formulated into herbicides to be used on roundup ready crops.

A stamped copy of the label is enclosed for your records. You must submit one copy of the 

### final printed label before you release the product for Shipment. 

### If these conditions are not complied 

### with, the registration will 

### be subject to cancellation 

### in accordance 

### vvith FIFRA. Your release for shipment of the product constitutes acceptance of these conditions. 

### If you have any questions please contact 

### Erik 

### Kraft at 

### 703-308-9358 or kraft.erik@epa.gov.ACTIVE INGREDIENT: 

### I



# Glyphosate 62%

MANUFACTURING CONCENTRATE

Glyphosale, N-(phosphonomelhyl)glycine, in the form of ils isopropylamine sail

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

### 62.0% OTHER INGREDIENTS:

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

### 38.0% TOTAL 

### 100.0%

Contains 769 grams per liter or 6.42 pounds per U.S. gallon of the active ingredient glyphosate, if)\Jt!.J(fwl\ltilJ' isopropylamine salt. Equivalenl to 

### 570 grams per liter or 

### 4.75 pounds per U.S.**\Jwillll~!IftS** glyphosale. 

## \,p In EPA Letter Dared' 

### ,\1\, 

## MAY 7**2!il~A** Reg. No. 

### 86461-XX EPA Est. No.

Under the Pedernllnsecticide, Fungicide. and RodenticideAci

os -.do( 

### ro..",,_

- under EPAReg. 

### No.



# ';j(,I-I&1

- 'V KEEP OUT OF REACH OF CHILDREN 

# CAUTION

PRECAUTIONARY STATEMENTS

ENVIRONMENTAL HAZARDS



### Do not discharge effluent containing this product into lakes, streams, ponds, estuaries, oceans, or other waters unless in accordance with the requirements of a National Pollutant Discharge Elimination System (NPDES) 

### permit and the permitting authority has been notified in writing prior to discharge. Do not 

### discharge effluent containing this product to sewer systems without previously notifying the local sewage treatment plant authority. For guidance, contact your State Water Board or Regional Office of the EPA.

PHYSICAL OR CHEMICAL HAZARDS



### Solutions of this product should be mixed, stored and applied only in stainless steel, aluminum, fiberglass, plastic and plastic-lined containers. DO NOT MIX, STORE OR APPLY THIS PRODUCT OR SOLUTIONS OF THIS PRODUCT IN GALVANIZED STEEL OR UNLINED STEEL (EXCEPT STAINLESS STEEL) CONTAINERS OR TANKS. 

### This product or solutions of this product react with such containers and tanks to produce hydrogen gas which may form a highly combustible gas mixture. This gas mixture could flash or explode, causing serious personal injury, if ignited by open flame, spark, welder's torch, lighted cigarette or other ignition source.

In case of: SPILL or LEAK, soak up and remove to a landfill.

FOR CHEMICAL SPILL, LEAK FIRE, OR EXPOSURE CALL CHEMTREC (800) 424-9300


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# .. , , Manufactured by: TF Holdings I, LLC P.O. 

### Box 1034 NET CONTENTS:

__ GALzl.:_,,_.

_ LB.13? :

Platte Cily, MO 

### 64079 "



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STORAGE AND DISPOSAL

Do not contaminate water, foodstuffs, feed or seed by storage or disposal. PESTICIDE STORAGE: Store above 32°F (O°C) to keep from crystallizing. Crystals will settle to the bottom. If allowed to crystallize, warm to 68°F (20°C) and mix well or recirculate to redissolve before using. {For Bul Pesticide Storage: Ground water contamination may be reduced by diking and flooring 

### of permanent liqui bulk storage sites with an impermeable material].
PESTICIDE DISPOSAL: Wastes resulting from the use of this product that cannot be used or'chemical! 

### reprocessed should be disposed of in a landfill approved for pesticide disposal or in accordance with applicable Federal, state or local procedures. CONTAINER DISPOSAL: Non-refillable containers. Do not reuse or refill this container. Offer for recycling, if available. Triple rinse or pressure rinse container (or equivalent) promptly after emptying. Triple rinse as follows. Non-refillable container less than or equal to 5 gallons: Empty the remaining contents into formulation equipment or a mix tank and drain for 10 seconds after the flow begins to drip. Fill the container 

### 1/4 full with**~ater** and recap. Shake for 10 seconds. Pour rinsate into formulation equipment or a mix tank or store rinsate for l<;lter use or disposal. Drain for 10 seconds after the flow begins to drip. Repeat this procedure**~o** more times. Non-refillable container greater than 5 gallons: Empty the remaining contents into formulation equipment or a mix tank and drain for 10 seconds after the flow begins to drip. Fill the container 

### 1/4 full with Iwater. Replace and tighten closures. Tip container on its side and roll it back and forth, ensuring at least

one complete revolution, for 30 seconds. Stand the container on its end and tip back and forth several imes. Tum the container over onto its other end and tip it back and forth several times. Empty the rinsate into formulation equipment or a mix tank or store rinsate for later use or disposal. Repeat. this procedure two

more times. Pressure rinse as follows (all sizes): Empty the remaining contents into formulation equipment or a mix ank and continue to drain for 10 seconds after the flow begins to drip. Hold container upside down over ormulation equipment or mix tank or collect rinsate for later use or disposal. Insert pressure rinsing nozzle in the side of the container and rinse at about 40 PSI for at least 30 seconds. Drain for 10 seconds after the

### ~ow begins to drip. Refillable container (250 gallon & bulk): Refill this container with pestiCide only. Do not reuse this container for any other purpose. Empty containers retain vapor and product residue. Observe all labeled safeguards until container is cleaned, reconditioned or destroyed, Cleaning the container before final disposal is the responsibility of the person disposing of the container. Cleaning before refilling is the responsibility of the refiller. To clean the container before final disposal, empty the remaining contents fr.om the container into ormulation equipment or mix tank, Fill the container about 10 percent full with water, Agitate vigorously or recirculate water with pump for 2 minutes. Pour or pump rinsate into formulation equipment or rinsate collection system. Repeat this rinsing process two more times, L-

________________________________________**~r~** ...**~~**

DIRECTIONS FOR USE

It is a violation of Federal law to use this product in a manner inconsistent with its latle;][rlg,;



### , , '"


### , "

, , , "



### ,


### "
, , This product may be reformulated or repackaged only into a herbicide for use on: ' , :

.. , : " ,



### , , 

### , 

### , , 

### , Fallow ground, pastures, sods, rangelands and noncrop areas including: aq13atlc:: and'\i\re'tland sites, rights of way, industrial, recreational and public areas, eucalyptus and hybrid poplar 'p'rbduction, tarmsteads, forestry site preparation and release programs, site preparation or directed sprays to the floor pJ:qmamental



# , '



### , , :" 2nurseries and Christmas tree·fal ") rights of way (ROW), Conservation R

## :~rve Program (CRP), turfgrasses and grasses for seed production. Residential Sites Tree and Vine Crops: general weed control, middles (between rows of trees), strips (in row of trees), selective equipment (except kiwi), perennial grass suppression. Row Crops: corn, cotton, peanuts, sorghum, soybeans, sugarcane, barley, buckwheat, millet, oats, rice, rye, teosinte, triticale, wheat, and wild rice. Citrus Fruits: calamondin, chironja, citron, grapefruit, kumquat, lemon, lime, mandarin orange, orange, pummelo, tangelo, tangerine and tangors. Tree Nuts: almond, beechnut, Brazil nut, butternut, cashew, chestnut, chinquapin, filbert (hazelnut), hickory nut, macadamia nut, pecan, pistachio, walnut. Vine Crops: grapes and kiwi fruit. Herbs: peppermint anq spearmint. Pome Fruits: apple, crabapple, loquat, mayhaw, pear and quince. Stone Fruits: apricots, cherry, nectarine, peach, plum and prune. Small Fruits and Berries: blackberry, blueberry, boysenberry, cranberry, currant, dewberry, elderberry, gooseberry, huckleberry, loganberry, olallieberry, raspberry and young berry. Fruiting Vegetables: eggplant, groundcherry, pepino, pepper (all), tomatillo and tomato. Cucurbit Vegetables: cantaloupe, casaba melon, chayote, Chinese waxgourd, citron melon, cucumber, crenshaw melon, gherkin, edible gourds, honeydew melon, honey ball melon, mango melon, melons (all), muskmelon, Persian melon, pumpkin, squash, watermelon. Root and Tuber Vegetables: artichoke (Jerusalem), beet greens, beets (garden, sugar), carrots, celeriac, chicory, ginseng, horseradish, oriental radish, parsnips, potatoes, radish, rutabagas, salsify, shallot, sweet potato, turnips and yams. Bulb Vegetables: garlic, leek, and onions. Leafy Vegetables: amaranth, arrugula, cardoon, celtuce, chervil, chrysanthemum, corn salad, cress, dandelion, dock (sorrel), endive, fennel (Florence), lettuce (head and leaf), parsley, purslane, rape greens, rhubarb and spinach (all). Brassica Leafy Vegetables: broccoli (all), Brussels sprouts, cabbage (all), cabbage (Chinese), cauliflower, cavalo broccolo, celery, celery (Chinese), chard (Swiss), collards, endive, kale, kohlrabi, mizuna, mustard greens, mustard spinach. Legume Vegetables: beans (all), lentils, chickpeas, peas (all), groundcherry, guar, pepino. Other Crops: asparagus, canola, litchi nut, mint (peppermint, spearmint), olives, okra, sunflower and watercress. Forage Crops: alfalfa, clover, forage grasses, forage legumes. Tropical Crops: acerola, atemoya, avocado, banana (plantains), breadfruit, canistel, carambola, cherimoya,

cocoa beans, coconut, coffee, dates, durian, figs, genip, guava, jaboticaba, jackfruit, longan, Iychee, mango, mangosteen, papaya, paSSion fruit, persimmons, pineapple, pomegranate, rambutan, sapodilla, sapote (black, mamey, white), soursop, sugarapple, tamarind and tea.

CONDITIONS OF SALE AND WARRANTY The DIRECTIONS FOR USE of this product reflect the opinion of experts based on field use and tests. The directions are believed to be reliable and should be followed carefully. However, it is impossible to eliminate all risks inherently associated with use of this product. To the extent consistent with applicable lalY, all such risks shall be assumed by the Buyer. ' , >' •• TF HOLDINGS I, LLC warrants that this product conforms to the chemical description on tl;lt3'].at}el and is reasonably 

### fit for the purposes referred to in the' Directions for Use subject to the.**jl)l)~rent** ris'k's teferred to above. TO THE EXTENT CONSISTENT WITH APPLICABLE LAW, TF HOLD<NGS;I, LL,C; MlKES NO OTHER EXPRESS OR IMPLIED WARRANTY OF FITNESS FOR ANY**PARTIClJL~.Fl** PURPq;;E OR OF MERCHANTABILITY OR ANY OTHER EXPRESS OR IMPLIED WARRANTY. THIElINARFlM1TY DOES NOT EXTEND TO, AND THE BUYER SHALL BE SOLELY RESPONSIBLE FOR; 'ANY At.;,m'ALL LOSS OR DAMAGE WHICH RESULTS FROM THE USE OF THIS PRODUCT IN**ANy'MANNE~** WHICH IS INCONSISTENT WITH THE LABEL DIRECTIONS. ",'

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### "

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### 3

### BUYER'S EXCLUSIVE REMEl AND MANUFACTURER'S OR SELL 

## Is EXCLUSIVE LIABILITY FOR ANY AND ALL CLAIMS, LOSSES, DAMAGES, OR INJURIES RESULTING FROM THE USE OR HANDLING OF THIS PRODUCT, WHETHER OR NOT BASED IN CONTRACT, NEGLIGENCE, STRICT LIABILITY IN TORT OR OTHERWISE, SHALL BE LIMITED, AT THE MANUFACTURER'S OPTION, TO REPLACEMENT OF OR THE REPAYMENT OF THE PURCHASE PRICE FOR THE QUANTITY OF PRODUCT WITH RESPECT TO WHICH DAMAGES ARE CLAIMED. When Buyer suffers losses or damages resulting from the use or handling of this product (including claims based on contract, 

### negligence, strict liability, or other legal theories), Buyer must promptly notify Seller in writing of any claims to be eligible to receive either remedy stated above. TO THE EXTENT CONSISTENT WITH APPLICABLE LAW, IN NO CASE SHALL TF HOLDINGS I, LLC OR THE SELLER BE LIABLE FOR CONSEQUENTIAL, SPECIAL OR INDIRECT DAMAGES RESULTING FROM THE USE OR HANDLING OF THIS PRODUCT. TF HOLDINGS I, LLC and the Seiler offer this product, and the Buyer accepts it, subject to the foregoing Conditfons of Sale and Warranty, which may be varied only 

### by agreement in writing signed 

### by a duly 

### authorized representative of TF HOLDINGS I, LLC No employee or agent of TF HOLDINGS I, LLC or the Seller is authorized to vary or exceed the terms of this Warranty in any other manner.

DISCLAIMER AND INDEMNITY FOR FORMULATORS' USES The manufacturer expressly disclaims all !lability for claims and actions (whether based on contract, tort, strict liability, or breach of warranty) arising out of, resulting from or connected with a formulation 

### containing this product when used for any purpose other than those uses set forth in the Directions for Use. The manufacturer has not developed scientific data to support, nor has it explicitly or implicitly approved, any uses other than those in the Directions for Use. Any formulator or buyer who uses this product in formulations for any other than those stated in the Directions for Use above assumes all liability for claims and actions arising out of, connected with or resulting from such use and agrees by so using this product to indemnify and hold harmless the manufacturer from such claims and actions.
This Disclaimer and Indemnity is in addition to, not in lieu of, the above Conditions of Sale and Warranty.

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## 'agrjk",szness professIOnals

January 12,2010

Document Processing Desk (REGFEE) Office of Pesticide Programs (7504P) US Environmental Protection Agency 

### One Potomac Yard
2777 S. Crystal Drive 

### Room S-4900, 4th Floor Arlington, VA 22202

Attention: Mr. James Tompkins (PM #25) " 

# //

RE: Glyphosate 62% Manufacturing Concentrate; EPA Reg. No. 86461-E 

### Resubmission ofCSF's Response to Agency Letter dated November 30, 2009 and PRIA Extension

Dear Mr. Tompkins:

With this letter and supporting documents, TF Holdings I, LLC is responding to the Agency's letter dated November 30 th

, 2009 and the resulting PRIA extension. In response to the product chemistry review, we have revised the basic CSF to be identical to that of the cited product chemistry submission. This was the only deficiency noted in the review. We have also included an alternate CSF. The following documents

are enclosed for your review:

1. One (1) Fonnulator's Exemption Statement (EPA Fonn 8570-27)
2. One (1) revised Basic and alternate # I CSF

Should you have any questions, or wish to reach me, please feel free to contact out office at 203-740- 1200,

Sincerely,

# Cr.M~~ Agent to TF Holdings I, LLC

115 Obtuse Hill· Brookfield, Connecticut 06804· USA 

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Voice: 203.740.1200· Fax: 203.740.1220· Email: lmiller@biologicconsulting.com 

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### Recommendation of Division Directors Negotiated Due Dates

Decision #: 419147 

# I Registration #: 86461·E 

# I Petition #:



### Fee Categorr: R300 PRIA Decision Time Frame:

Submitted by: Jim Tompkins Branch: HB 

# I Date: 12·10·09

Company: TF Holdings LLC

Original Due Date: 12·16·09 Proposed New Due Date: 5-9-10

Previous Negotiated Due Dates:

Is the "Fix" in-house? no If 

### not, date "Fix" expected: 1-9-10
Issue (describe in detail): The Company must provide Group A and Group B Chemistry data. The
company cited another product's Group A and B Chemistry data and the Technical Review Branch chemist determined that the proposed product was not similar to the cited product and that the registrant had to provide their own Group A and B Chemistry data.
Summary of Deficiency Type(s): Not Submitted (N) 

### Deficiencies (D) 

### Product Chemistry: _X_ Acute Tox:

_ Efficacy:

__ Labeling:

_ Other (describe):



### --

Describe Interactions with Company (describe when contacted and company's response including
response to previous negotiated due dates): The Company is aware of the change of the PRIA Date and they understand that the product can't be registered until they provide Group A**~d** 

### B Chemistry data and that the data is determined to be acceptable.

"75 Day" Letter scnt?



## __ X

__ Yes No and reason for none?

- 

### 11·30·09 sent 75-Day Letter

Rationale for Proposed Due Date: The registrant needs 1 month to submit the' data. TRB Chemists will 

### need 3 months to review the data and RD will need I month to process the action. Thus the need for a 4 month extension from the date the company submits the data (5-9-10).



## - Registrant noti)1fd that this is the last negotiation? Not Applicable
Approve:_V_ 

# I Disapprove:

If 

### disapproved, action to be taken:



## n

, 

### OD or DOD Signature: 

# I "--,. L- 

### Date:



# ru \Ct.,; 12-iL{-o0 " 

# V v 

# \.- , v 

# ,

Form revised: May 2007December 9, 2009

Mr. James A. Tomkins
Product Manager, Team 25
Herbicide Branch 

### )

Registration Division (7505P)
Office of Pesticide Programs U.S. Environmental Protection Agency Arial Rios Building
J200 Pennsylvania Avenue, N.W. Washington, D.C. 20460**{1:Af/"~**

# ~ 

# L,0Ji**O;;-CIX:S;~::,c.** agr(bJ.tsmess professIOnals

/.//

SUBJECT: EPA File Symbol**8646I~E** "Glyphosate 62% Manufacturing Concentrate".

Dear Mr. Tompkins:

This is in response to your 75 day letter dated November 30, 2009 regarding the above application.

On behalfofTF Holdings I, LLC, we are requesting an extension of the PRIA due date in order to complete and submit Group A and B Product Chemisty. This will be completed within 30 days from the date of this letter. We understand that the PRIA extension will be 4 months from the date that the product chemistry studies are submitted to the EPA.

# r1ore~~~

UM.Miller Agent for TF Holdings I, LLC

115 Obtuse Hill. Brookfield, Connecticut 06804· USA Voice: 203.740.1200· Fax: 203.740.1220· Email: Imiller@biologicconsulting.com

# / I

Re: 86461-E, TF Holdings Glyphosate 62% 

### ['j Erik Kraft to: Jane Miller Cc: Jim Tompkins


# --.---- 

# -_._

.... 

# _-

Dear Jane, 12/07{2009 08:31 AM

I have reviewed your rebuttal and talked it over with the Chemistry Branch Chief, Debbie McCall. In response to your argument.

1. The formulator exemption covers generic data, not product chemistry when you are fOmlulating a product, and you are formulating a product.

2. Linda reviewed your proposed csf versus the basic csf of 83520-6, the 2 alternate csfs are pending approval. The chemists only review your proposed to the basic csf on file.

3. Your product is not identical to the cited product, you must list all impurities of toxicological concern on your CSF, and you must provide Group A and Group B data. You are producing your own product and
you have to provide product chemistry data on that product.



### 4. We are unable to register your product at this time due to insufficient chemistry data. If you want us to make a regulatory decision by Dec. 162009, we will proceed with a not-grant on this registration. If you wish to renegotiate the PRIA date you must respond in writing by Dec. 9, 2009 with a date that you expect to be able to provide Product Chemistry data on this product and the New PRIA date will be 4 months from that day.

Thank You Erik

"Jane Miller"

From: To: Date: Subject:

Dear Mr. Kraft: Dear Mr. Kraft:

"Jane Miller" <jmiller@biologicconsulting.com> Erik KraftfDC/USEPAlUS@EPA 12104/2009 10:20 AM Re: 86461-E, TF Holdings Glyphosate 62% 12/04/2009 10:20:33 AM



## • Please find attached our response to the Agency's letter dated November 30 ,2009. We will send the original via overnight mail today. We are hopeful that this can be resolved and that TF Holdings may 

## " receive its registration approval by the December 16 PRIA due date.

Best Regards,



## J Ct-f>'\£/ 

### /vi. /vi 

### £.Ue.rBIOLOGIC, Inc.
115 Obtuse Hill Road Brookfield, CT 06804

Tel: 203-740-1200
Fax: 203-740-1220

## )

December 3, 2009'



### Mr. James A. Tomkins Product Manager, Team 25 

### Herbicide Branch Registration Division (7505P) Office of Pesticide Programs 

### U.S. Envirorunental Protection Agency Arial Rios Building 1200 Pennsylvania Avenue, N.W. Washington, D.C. 20460

SUBJECT: EPA File Symbol 86461-E: "Glyphosate 62% Manufacturing Concentrate",



### Dear Mr. Tomkins:

This is in response to your letter transmitted by Mr. Erik Kraft 

### in his email dated November 30, 

### 2009 regarding the above subject. We have reviewed your letter, as well as the November 27, 2009 memo from Linda 

### L. Kutney, and wish to make the following observations and comments:



### 1. The subject application submitted by TF Holdings I, LLC (EPA File Symbol 86461-E) is



### a proposed manufacturing use product (MUP) based on the fonnulator's exemption provision of 

### F1FRA. You may note that a Fonnulator's Exemption Statement (EPA
Form 8570-27) was submitted with the application on August 25, 2009.

2. Dr. Kutney's memo indicates that the proposed product is not substantially similar or identical to the Confidential Statement of Formula (CSF) of the cited product, EPA Reg. No. 83520-6, -because it is produced usng a different source of the technical grade active ingredient (IGAl). 

### It is not clear to us which CSF (or CSFs) Dr. Kutney might have reviewed, however, we would like to point out that alternate CSFs were submitted to the Agency by notification on January 10,2009 and February 18,2009 listing different TGAI

sources for EPA Reg. No. 83520-6 (see the attached copies of those notifications). As
per PR Notice 98-10, we did not receive a 30·day response from the Agency stating that these submissions did not qualify as notifications.

3. Please note that the CSF submitted on January 10, 2009 for EPA Reg. No. 83520-6 is identical to the CSF submitted for the subject product and, therefore, we request the Agency reconsider 

### its determination of substantial similarity in light of this information.

1 I 5 Obtuse Hill· Brookfield, Connecticut 0680.4· USA Voice: 203.740.1200· Fax: 203.740.1220· Email: lmilJer@biologicconsulting.com

### Jane Miller Biologic Inc. 115 Obtuse Hill 

### \

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

OFFICE OF PREVENTION, PESTICIDES AND TOXIC SUBSTANCES



### Brookfield, Connecticut 06804



### Dear Ms. Miller:

Subject: EPA Reg. 86461-2/ Glyphosate 62% Manufacturing Concentrate Deficiencies

The Agency has received and initially reviewed the subject application and has determined that it is incomplete or that further infonnation is needed. This letter is a written notification of those
deficiencies and identifies your options under 40 CFR 152.105 and Section 33 of the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA), as amended by the Pesticide Registration 

### Improvement Act (pRIA). Your options under 40 CFR 152.105 and section 33 ofFIFRA are addressed separately because each involves a different timeframe and set of options for responding to this letter. Please ensure that you consider each of the sections below in determining how and when you respond to this letter.

40 CFR 152.105:

Pursuant to 40 CFR 152.105, you are allowed 75 days from the date of this letter (you must respond by December 9, 2009 due to the PRIA deadline) to provide a response concerning the deficiencies listed in this letter. Your response may include making corrections or additions to complete the application, or notifying the Agency of the date on which you expect to complete the application, or withdrawing your application. If you do not respond to this letter within 75 days or if you respond with a date on which you expect to complete the application but fail to
meet that scheduled date, the Agency will treat the application as if you had withdrawn it.
Withdrawal concludes the Agency's review of your application. Any subsequent submission of the same application must then be submitted as.a new application \Vith a new deadline for responding and subject to a new registration service fee.

The deficiencies identified in the Agency's review at this time are as follows:

1. The basic CSF is not acceptable. The CSF must include all impurities of toxicological

concern which are present from the starting materials andlor the manufacturing processes (See 40 CFR 158.325 

### part C).

2. The product chemistry of the proposed 'product is not substantially similar or identical to that of the cited product (EPA Reg. 83520-6), because the proposed product is produced using a different source active ingredient and contains an additional impurity of toxicological concern. The toxic impurity profiles of the proposed product and the cited product are not similar from a product chemistry perspective.

# 'r--------------------------

Mr. Tomkins 

### 12/3/09

4. Dr. Kutney's memo further indicates that the 

## CSF for the proposed product must include 

### all impurities of toxicological concern 

### and, in particular, her review mentions Because the proposed product is a formulated 

### MUP produced by 

### the amination of gIyphosate acid technical with 

### isopropylamine, 

### it will

not generate any impurities other than those found 

### in the TGAI. In addition, since the TGAI is a registered source of the active ingredient, it is a reasonable asswnption that a preliminary analysis of the TGAI was submitted and approved by the Agency in support ofits registration. 

### With this in mind, we believe the proposed CSF should be acceptable, and the cited product chemistry studies are adequate to meet the data requirements of this formulated MUP.

.



### 5. Finally, Dr. Kutney's memo refers to 40 CFR 

### § 158.325(C), which includes the submission of",

, . all infonnation that the applicant knows (or that is reasonably available to him), 

### concerning the composition (and 

### if requested by the Agency, chemical

or physical properties) of the starting material, including a copy of all technical specifications, data sheets, or other documents describing 

### it." Please note that this information was submitted under the cited Product Identity and Composition provided in 

### MRlD No. 47042001.



### We believe the 

### above infonnation should clarify all 

### the issues concerning this application, and

we 

### look fOIWar'd to receiving the registration approval according to the original PRTA decision date.

Should you have any questions or otherwise wish to reach me, please feel free to contact my office at 203-740-1200.**'** 

### 1y, 

## \ !Y\

# IY'\~ J . Miller Agent for 

### TF Holding I, LLC

### 3. Product chemistry Group A and B data from the cited product (EPA Reg. 

### 83520-6) are
not acceptable to support the proposed product because it contains additional impurities of toxic concern. All product chemistry data must be furnished using the proposed MUP.

Further review of your application and your response to the deficiencies may identifY additional deficiencies and you will 

### be so informed.

FlFRA Section 331PRlA:

This application is also subject to a deadline for making a determination on the application under FIFRA Section 33, Pesticide Registration Service Fees, established under PRIA. The time frame for the Agency to make a determination on this application ends on December 16,2009. You have the following three options:

1. 

### Establish a new due date. You may work with us to establish a new section 33IPRIA 

### deadline that allows for an appropriate response to the 75 day letter. If you choose this option, you need to contact the Agency not later than December 9, 2009 to discuss a time frame that allows you to address the deficiencies listed above and the Agency to make a regulatory decision.

2. Withdraw the application. Alternatively, you may notify us not later than December 9,2009 that you are withdrawing your application. As noted above, withdrawal concludes the Agency's review of your application; however, you may resubmit your application after the deficiencies have been addressed. Should you choose to resubmit your application, it would be subject to a new deadline for responding to the application and a new registration service fee. Since a fee was paid with this application, the Agency will provide any applicable refund as soon as practicable.

3. Not respond. If the Agency does not hear from you by December 9, 2009, the Agency in meeting its obligations under section 33IPRIA 

### may issue a detennination

to not grant your application. Vihile a detennination to not grant an application would allow EPA to have met 

### its obligation under section 33 ofFIFRA to issue a detennination by a specified date, this detennination is neither a denial of the application pursuant to section 3(c)(6) ofFIFRA or a withdrawal ofthe application. Thus, the Agency will continue to diligently work on any such application as long as EPA receives a response to the/a deficiency within the 75 days described above.

Please respond to this letter by December 9, 2009 by contacting Erik Kraft at 703-308-9358 or email atKraft.Erik!a>.epa.gov with a response and for any questions concerning this letter.

Sincerely,August 25, 2009

Document Processing Desk (REGFEE) Office of Pesticide Programs (7504P) US Environmental Protection Agency One Potomac Yard 2777 S. Crystal Drive Room S-4900, 4th Floor Arlington, VA 22202

Attention: Mr. Jim Tompkins (PM #25) RE: Glyphosate 62% Manufacturing Concentrate; EPA Reg. No. 86461-X Application for Pesticide Registration

Dear Mr. Tompkins:

On behalf ofTF Holdings 1, LLC, we are submitting this Application for Pesticide Registration for the abovementioned product. The subject product, containing glyphosate technical, is a manufacturing concentrate for formulation into end-use products. The nominal concentration of glyph os ate in the product is 62.0% w/w.

The following documents are enclosed to process this registration:

Volume I Administrative Materials

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

• Letter of Authorization to cite data from Axss USA, LLC

• Certification With Respect to Citation of Data (EPA Form 8570-34)

• Data Matrix (EPA Form 8570-35)

Formulator's Exemption Statement (EPA Fonn 8570-27) Confidential Statement of Formula (EPA Fonn 85704) Five (5) copies of draft labeling

This application is submitted under the Formulator's Exemption Provision ofFIFRA section 3(c)(2)(D). In addition, according to FIFRA section 3(c)(3)(b)(i), this application qualifies for an expedited review on the basis that this product is identical in composition and labeling to "Glyphosate 62% Manufacturing Concentrate", EPA Registration Number 83520-6.

To fulfill the product chemistry data requirements, TF Holdingsl has received a letter of authorization from Axss USA to cite to product chemistry data. To satisfy the acute toxicity data requirements, TF Holdings has chosen the cite-all option under the selective method of support and has sent offer to pay letters to all companies appearing on the EPA Data Submitters list for glyphosate.

This application for a new pesticide product will fall within the category on Table 4 - Registration Division: New Products, EPA No. R300; CR No. 44. The PRIA fee for this application is $1,365.

, , , , Should you have any questions, or wish to reach me, please feel free to contact our office at 203-740-1200. ' , , , , .

### ~ ", / \ce;eI Y

, . ' , ' , ' 

# 1\,**iY\.I'Y\~** ": "

J'MilIer ' , ,
0 , ) Agent to TF Holdings I, LLC )') ,

",

,

ll5 Obtuse Hill- Brookfield, Connecticut 06804

- USA Voice: 203.740.1200

- Fax: 203.740.1220

- Email: lmiller@biologicconsulting.comForm Approve ,18 No. 2070-00&0. Ar;Jprovai ExPires 5·31·98.
Unitlld stilt

.. 

# &EPA Environmental Protection Agencv
w

.. llingten. DC .20460 

## Formulator's Exemption Statement 140 CFR (52.85)
Applicant's Name and Addrll.lls EPA Fil. Symboliflegistration Num;"er

TF Holdings I, LLC 86461·XX P.O. Box 1034 Platte City, MO 64079 Product Name Glyphosate 62% Manufacturing Concentrate

Date of Confidentilll Stlltement of Formule (EPA Form 8570-4)
August 5, 2009

As an authorized representative of the applicant for registration of the product identified above, I certify that:

(1) This product contains the following active ingredient(s):

Glyphosate

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

(3) Indicate by checking (A) or (S) below which paragraph applies:

## ~ (A) An accurate Confidential Statement of Formula (EPA FORM 8570-4) for the above identified product is attached to this statement. That formula statement indicates, by company name, registration number, and product

name, the source of the active ingredient(s) listed in paragraph (1). 

# 0 OR (B) The Confidential Statement of Formula (CSF) (EPA Form S570·4) referenced above and on file with the EPA is complete, current, and accurate and contains the information required on the current CSF.

(4) The following active ingredients in this product Qualify for the formulator's exemption.



### Source

Active**Ingr~ient** Product Neme Regi$t!ation Number

Glyphosate Technical 

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## . Signature J

## ~ Name and Title Date

# \1~O7 )" 

### ,
Jane M. Miller. Consultant

EPA Form 857o.y'(RO 8·S5} White· EPA copy Yellow· Applicant copy *U.$.GPO: 1 

# , '--"

### -' Where Products 

### and Markets Merge



### Axss USA, LLC 1100 Plate Falls Road Platte City, MO 64079



### Mr. James Tompkins Product Manager; PM Team #25 Herbicide Branch; Registration Division (7504P) Office 

### of Pesticide Programs 

### & Toxic Substances U.S. Environmental Protection Agency One Potomac Yard; 2777 South Crystal Drive 

### Room S-4900, Fourth Floor Arlington, VA 22202 August II, 2009

SUBJECT: Authorization to Rely on Data Submitted by Axss USA. LLC

Dear Mr. Tompkins:

Axss USA. LLC (AXSS) hereby authorizes the U.S. Environmental Protection Agency (EPA) to refer to data previously submitted by AXSS to support the Application for Pesticide Registration for "Glyphosate 62% Manufacturing Concentrate" (EPA File 

### Symbol Number 86461-XX) submitted by TF Holdings I, LLC. TF Holdings has cited
the following studies on its Data Matrix:



### Product Chemistry: MRlD No. 47042001 Physical/Chemical Properties: MRID 47042002 Storage Stability & Corrosion Characteristics: MRID No. 47509201

, 

### , , ,

, 

# . , , Should you have any questions concerning this authorization or otherwise wish to reaph , ' > me, please feel free to contact my office at 970-506-0198.

., , '> " , ,

, 

# . Sincerely.

Kevin Howard Owner 

### Axss USA, LLC , 

### "



# . 

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## PRlA 2 - 21 Day Content Screen Review Worksheet (EPA/OFP Use Only)**~** 

### 3/23/09 21 Day Screen Start Date:

### -,---,ISL--:::.;(;'-"~:';-"--"C>"-<;L- ___ 

### -=:---:;--o-. FeePaid:**Yes~** Experts In-Processing Signature: 

### --Cc"lS=-Lf'.-=-",:'

___ -:-::- Date**8-~"8-.o9** 

### Division management contacted on issues No,

___ Yes

___ -'Date

_____ _

EPA Reg, Number:

# ~(,t.f(,1**~;;** EPA Receipt Date:,?-.;(,:; 

### -09

Items for Review Yes No N/A*



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

### complete 

## f/Z- including package type

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

# If)«

dated (EPA Form II> '0,4) fT.;-1.- ) 

### forml 2 a) All inerts (link 1D http://www.epa.gov/opprdOOllinerts/), yes no 

### including fragrances, approved for the proposed uses (see 

## )!.. Footnote A)

.



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

# )Z form) completed and signed 

### (N/A iflOO% repack)

Certificate and data matrix consistent

## ~.
If applicant is relying on data that are compensable, is the offer yes no
to pay statement included. (see Footnote B)



### If, k," • 

### is there a letter of .• c



### , use only. 

### 'Mor', Exemption Statement (EPA Form 8570-27) (Link to fonn) 

### 4 and signed (N/A 

### if source is unregistered or applicant owns the 

# J(

,n

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

# ~ copies (PR 98-5) (Link to PR 98-5) completed and signed 

### (N/ A if 100%

yes no 

# .r>

5 . . 

### a) Selective Method (Fee l 

### use) 

# Y- 

# > ;'

,**·~c/** 

### b) Cite-All (Fee category experts use) 

## c· .•**~.** 

## .'

.

# l~I~~~~f,i:ii;-' c) Applicant owns all data (Fee category experts use) 

## ..:c

.

5 Copies of Label (Iiok to htto://www,eQa,gov/oQQfeadlllabellogllrmf) 

# J( 6 (Electronic labels on CD are encouraged and guidance is avaiIable)( link to http://www.epa.gov/pesticldes/regulatinglregistering/submissions/index.htm#labels 

# I )

I

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

# X

Notice of Filing (liok to 8 

### htto://www.ena.ggv/];!esticides/regylatlnf!ltolerance I!etitions.htm) included with petitions (liok to**http://www.epa.~ov/pesticides/regulating!tolerances.htm)** 

# ><-

9 

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

### 7- http://vf,,w.epa.gov/opprdOOllworkplanireducedrisk.html)



### Required Data Oink to 

### h 

### tto :ll"""",,w.e}!a.goY l)!esticides/regulatin2f data reguirements.htm) and/or data waivers. See Footnote C.



## aJ List study (or studies) not included with application



### 10

,



### 2

### Comments:



# * N/A

- 

### Not Applicable

Footnotes

A. During the 21 day initial content review, all CSFs 

### will be reviewed to determine whether all inerts listed, including fragrances, are approved for the proposed uses. If an unapproved inert is identified, the applicant must either 1) resolve the inert issue by, for example, removing the inert, substituting it with 

### an approved inert, submitting documentation that EPA approved the inert for the proposed pesticidal uses, correcting mistakes on the CSF, etc. or 2) provide the data to support OPP approval of the inert or 3) withdraw the application. Removing or substituting an inert ingredient will require a new CSF and may require submission of data. All infonnation. fOnTIs. data and documentation resolving the inert issue must have been received by the Agency or the application withdrawn within the 21 day period. otherwise. the Agency will reject the application as described below.

To successfully complete this aspect of the 21 day initial content screen, applicants are strongly encouraged to verifY that all inert ingredients have been approved for the application's uses even if a product is currently registered by consulting the inert Web

3

### site [link to http://www.epa.gov/opprdOOl/inertsllists.html] and if the inert 

### is not 

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

to register a pesticide product containing that inert ingredient. Some inert ingredients are no longer approved fur food uses or certain types of uses. The name and/or CAS number on a CSF must match the name and CAS number on this web site. 

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

### in proyessing delays.

If an 

### inert is not listed on the inert ingredient web site and the applicant believes that the inert has been approved, the applicant should contact the Inert Ingredient Assessment Branch (IIAB) at inertsbranch@epa.govandresolvetheissue. Copies of the correspondence 

### with lIAB resolving the issue should accompany the application. All

new 

### inerts except PIP inerts are reviewed by lIAB. The lIAB should also be contacted for any questions on what supporting data needs to be submitted for and the Agency's inert review process. Questions on PIP inerts should be directed to the Chief of Microbial Pesticides Branch [Link to**http://www.e~a.gov/o~pbppdllbiopesticideslcontacts** 

### bppd.hhnJ.

"When a brand, trade, or proprietary name of an inert ingredient is listed on a CSF, additional information such as an alternate n'ame of the inert, CAS number or other information [link to http://www.epa.gov/opprd001Iinerts/tips.pdt] must also be included

to enable the Agency to determine if it has been approved. Each component of an inert mixture (including a fragrance) must be identified. 

### In some cases, the supplier of the mixture or fragrance may need to provide this information to the Agency. Prior to the Agency's receipt of an application, applicants must arrange with a proprietary mixture or fragrance supplier to provide the component information to the Agency or promptly upon EPA's request. If the inert ingredients in a proprietary blend (including fragrances)

cannot or are not identified or provided within the 21-day content review period, the Agency will reject the application.

During the 21 day content review, applicants should submit information to the individual identified by the Agency when the applicant is informed of an unapproved inert.

Unapproved Inerts Identified on CSFs



### All applications except conventional new products and PIPs

Once an unapproved inert is identified on a CSP, the Agency will contact the applicant with the following options:

1. Correct the application by, for instance, correcting the inert's identity or CAS number, providing documentation that the inert has been approved, or removing the unapproved inert from the CSF or replacing it with one that is approved for the application's uses; or

2. Submit the information and data needed for the Agency to approve the unapproved inert. Ifthis option is selected and implemented, the Agency may request an extension in the PRIA decision review timeframe to accommodate the inert review/approval process;



### 4i


### 3. Withdraw the application (the Agency retains 25% ofthe full fee for the fee category estimated); or

Ifnone of these options is selected and implemented 

### by the applicant within the 

### 21 day content review period, the Agency will reject the application and retain 25% of the full fee of the category identified.

Conventional New Product Awlications

When the Registration Division identifies an unapproved inert on a CSF with an application for a new product that the applicant has not identified as requiring an 

### inert approval (R31l, R3l2 or R3l3), it will contact the applicant with the following"options:



### L Correct the application by, for instance, correcting the inert's identity or CAS number, providing documentation 

### that the inert has been approved, or removing the unapproved inert from the CSF or replacing it 

### with one that is approved for the application's uses; or

2. Submit the information and data needed for the Agency to approve the unapproved inert, including any required petition to establish or amend a tolerance or exemption from a tolerance. (This option may change the PRIA category for the application, which could require a longer decision review time and a larger fee. If additional fees are due, they must be received by the Agency within the 21 day content review period.)

3. Withdraw the application (the Agency retains 25% ofthe full fee for the fee category estimated); or

If none of the above options is selected and implemented during the 21-day content-review period, the Agency will reject the application and retain 25% of the appropriate fee for the new product-inert approval category.



### PIP Applications

When the Biopesticide and Pollution Prevention Division identifies an unapproved inert on a PIP CSF and a request to approve the inert does not
accompany the application, it will contact the applicant with the follo'Wing options:

1. 

### Correct the application by, for instance, correcting the spelling or name of the inert to that 

### in 40 CFR 174, or providing documentation that the inert has been approved; or

2. Submit the infoID1ation and data needed for the Agency to approve the unapproved inert. If an inert ingredient tolerance exemption petition is required, the petition must be received by the Agency and the B903 fee paid 'Within the 21 day period. If this option is seleeted and implemented, the Agency will discuss harmonizing the timeframe for both actions.
5

### 3. Withdraw the application (the Agency retains 25% of the full fee for the fee category estimated); or

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

content review period, the Agency will reject the application and 

### retain 25% of the fee.

B. A policy on documentation of offers to pay is still being developed, however, for a me-too or fast track (similar/identical) new product, R300 or A530, an application without the necessary authorizations of offers to pay will be placed into either R301 or A531. The Agency recommends that authorizations of offers to pay be submitted with other PRIA applications to avoid delays in the Agency's decision.



## c. Biopesticide applicants are advised to contact the Agency and discuss study waivers prior to submitting their application to the Agency. Documentation of such discussions should be submitted with the study waiver.

6UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D,C, 20460



### August 27, 2009

OPP Decision Number: D-419147 EPA File Symbol or Registration Number: 86461-E OFFICE OF PREVENTION, PESTICIDES AND TOXIC SUBSTANCES



### Product Name: GL YPHOSATE 62% MANUFACTURING CONCENTRATE EPA Receipt Date: 26-Aug-2009
EPA Company Number: 86461 Company Name: TF HOLDINGS I, LLC

JANE M. MILLER BIOLOGIC, INC.
TF HOLDINGS I, LLC 115 OBTUSE HILL ROAD BROOKFIELD, CT 06804-

SUBJECT: Receipt of Registration Application Subject to Registration Service Fee



### Dear Registrant:

The Office of Pesticide Programs has received your application and certification of payment. 

### If you submitted data 

### with this application, the results of the PRN-86-5 screen will be communicated separately. During the administrative screen, the Office of Pesticide Programs 

### has determined that this Action is subject to a Pesticide Registration Service Fee as defmed 

### in
the Pesticide Registration Improvement Act.

The Action has been identified as Action Code: R300

NEW PRODUCT;ME- TOO PRODUCT FAST TRACK;

No additional payment is due at this time.



### If you have any questions, please contact the Pesticide Registration Service Fee Ombudsman at (703) 305-6249.

Sincerely, 

# c-\ 

# 1'£/I.,UUL**~** Front End Processing Staff Information Technology & 

### Resources Management Division

# IFee 

# for Servicel j,
{856644<-**~------------------------** j 

### This package includes the following for Division

I @ 

# New Registration

°Amendment 

# OAD

oBPPD @RD


# I 0 

# Studies? 0 

# Fee Waiver? Risk Mgr. 

# []I]

I 

### \ 0 

# volpay 

# % Reduction:

L

# Receipt No. 

# s-I 856644

EPA File Symbol/Reg. No. 

# I 86461-E

Pin-Punch Date: 

# I 8/26/2009

[J 

# This item is NOT subject to FFS action.

# Actiuni~ude: 

# i I Parent/Child Decisions: I

I 

## Requested: 

# I R.3CO 

# II

i Granted: 

# I f<,. 

## 300 

# I 

# II

\ Amount Due: 

# $ 113<05 

# 'I**~** '<

# ~ .. 

# J.M**'8jzl~,--------------1** iii Inert Cleared for Intended Use 'Ii' 

## Uncleared Inert in Product

Reviewer:·

__

# :::...01:.r-;.01--,-"Mo-=-VL~ 

# ____ _ Date: 

# 8/'-;;'7/0'1

Remarks:

# FEE 

# FOR SERVICE

### Jane Miller

From: Sent: To: Subject: paygovadmin@maiLdoc.twaLgov Tuesday, August 25, 2009 3:59 PM jmiller@biologicconsulting.com Pay.Gov Payment Confirmation



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



### Your transaction has been successfully completed.

Payment Summary

Application Name: PRIA Service Fees Pay.gov Tracking 1D: 24VNFBFN Agency Tracking 1D: 74079251968

Account Holder Name: Jane M. Miller 

### Transaction Type: Sale Billing Address: 115 Obtuse Hill Road City: Brookfield 

### state/Province: CT Zip/Postal Code: 06804 Country: USA 

### Card Type: Visa 

### Card Number: ************8698 Payment Amount: $1,365.88 Transaction Date: Aug 25, 2889 3:59:23 pM



### Decision Number: Registration Number:

1 ,"

, " " "

,



### , , "

,



### "

, 

### "

",
,



### , ,

" ,

## . . . . Form Ar 'ed OMB No 2070-0060 Approve! Expires 5-31 98

Unit"d State. 

# oEPA Environmental Protection Agency Wuhington. DC 20460 

## Formulator's Exemf:tion Statement I (40 CFR 1 2.85J
Applicllnt's Name**~lnd** Address EPA FIle SymbollRegi,trotion Numiler

TF Holdings I, LLC 86461-E P.O. Box 1034 PlatteC'lty, MO 64079 Product Name Glyphosale 62% Manufactuflng Concentrate

Oat. of Confidontial Statement of Formula (EPA Form 8570-4J

December 31, 2009

As an authorized representative of the applicant for registration of the product identified above, I certify that:

(1 ) This product contains the following active ingredient(s):

Glyphosale

(2) Of these, each active ingredient listed in paragraph (4) is present solely as the 

### reswt of the use of that active ingredient in the manufacturing, formulation or repackaging another product which contains that active ingredient which is registered under FIFRA Section 3, is purchased by us from another producer, and is labeled for at least each use for which my product is proposed to be labeled.

(3) Indicate by checking (A) or IS} below which paragraph applies:

## ~ (A) An accurate Confidential Statement of Formula (EPA FORM 8570-4) for the above identified product is attached to this statement. That form

.... a statement indicates, by company name, registration number, and product

name, the source of the active ingredient(s) listed in paragraph (1). 

# D OR (S) The Confidential Statement of Formula (CSF) (EPA Form**8570~4)** referenced above and on file with the EPA is complete, current, and accurate and contains the information required on the current CSF.

(4) The following active ingredients in this product qualify for the formulator's exemption.



### Source

Activo Ingredient Product Name Registration Number

Glyphosate Technical Q



### , ,

, '
, , 

### "



# .

,

, ! ' , , "

, ,) 

### ,

, 

### ,

,

, '"

,

# Sign~ 1(\'\ 

# fY\:J Name and TItle Date 

# Il.h ' jZ-Q)D 

### q Jane M. Miller. Agent

EPA**~** 0-27 (Rev. 8-95) White • EPA copy Yellow**~** ApPlicant copy

# ""n. .d i".tnmtJon. on ,. 

# . ..,.**~m** 19 

### form. Fonn**Approv~** MB No. ,.O7().()()8(l t1itH 2.28-95

Unitod Stetos 

# 8

Registration opp Idontifier Numbor 

# aEPA Environmental Protection Agency Amendment Washington, OC 20460 

### Other Application for Pesticide

- Section I

t.**com~~(lduct** Numbor 2. EPA Product Menager 3. Proposod Classification 86461- 

# !9 J. Tompkins 

# o
None 

# o
Rflstrict&d 4. Company/Product (Namllj PM.

Glyphosate 62% Manufacturing Concentrate 

### 25

5, Namo end Address d Applieont flnc/udo ZIP Code} 6. Expedited Reveiw. In accordance with FIFRA Section 3{c){3J 

### TF Holdings I, LLC (b){i). my product is similar or identical in composition and labeling 

### P.O. Box 1034 to; 

### 83520-6 Platte City, MO 64079 EPA Reg. No. 

# o
Check if this is 8 new sddress Product Name 

### Glyphosate 62% Manufacturing Concil

Section

- II 

# 0 Arnondment· Explain billow. 

# U Finor printed labols in repsonse to Agency letter datad 

# 0 Resubmission in responsa to Agancy lettar deted 

# 0 wMe Too w Application. 

# 0 Notification

- Explain balow. 

# 0 Other

- Explain below.

Explanation: Use additional page(s) if n

.... cessary. IFor soction I and Section 11.)

This applicallon for a new pesticide product will fall within the category on Table 4 - Registration Division: New Products as published in the August 2008 Federal Register. This product is further defined under EPA No. 300; CR No. 44. 1F Holdings is citing to product chemistry studies previously submitted to the EPA and is using the Cite-All method of support for acute toxicity data. The PRIA fee is $1,365 for this application.

Jane Miller Tel: (203) 740-1200; Fax: (203) 740-1220; Email: imiller@biologicconsuHing.com



### Section

- III

,. Metorial Thr. ProduC1 Will Be peckaged In:

Child-Resistant Packaging Unit Packaging Water Soluble Packaging 2. TYPe of Containor 

# [2jY", [2jY"

# ~ Y"

# ~M'''' .f No .f No .t Plastic No Glass 

### * Certif"teation must If wYosW No.**p~r** If ·Yes w No. par Paper Unit Packaging wgt. contemer Packege wgt container OtMr (Specify) be submitted

.**~** 3. Location of Net Contents Information 4. Size Is) Retail Conteiner 5. Locatien of label Directions



### [{j Label 

# U Conteinar 50,250 gal. 

# bJ

on label

6. Mannar in Which labal is Affixed to Product

### ~UthOgraPh 

# 0 Other Papar**~[uod** Stenci ed 

### Section -IV 

# . , 

### "



### , , ,

, , • > t. Centact Point (Comp/ern items dlrect/y bnJow for identificstion of individu81 to b. ccntoct.d, if nfICeSllery, to proCO$!l thill apPIit;I..'t.'omJ

Name Titla 

### ., , TCJI,!p,h,o,ne No_ Uncl}lda Area Code)
Jane M. Miller Agent ,203-741)-1200"

, 

### , 

# - Certification , 6. Dote Application

I certify thet the statements I have made on this form and oil attachments thereto aro true. accurete and**c0"!Pl~t~. R,ctii~,**  I acknowledga thet any know6nglly felse or misleading statement may be punishablo by fine or impnsorvnent,o,r; 

### '(S;amoed)

both under applicablolaw. ",



### , 2. Signature 3. Title , ."

, 

# /\ M !';\ 

## ,\\1 Agent 

### "

, ,"

-
4. Typed Nam 5.0ate

Jane M. MilleK.-/ 

### August 25, 2009



## .. EPA Form 8570-' (ReY. 3-94) PreVIOUS editions ara obsolote. . 

### .. Whrte " EPA File Coov lonamaltBasedonFormApprovedOMBNo.2070·0060UNITEDSTATESENVIRONMENTALPROTECTIONAGENCY401MStreet,S.W.WASHINGTON,D.C.20460PaperworkReductionActNotice:ThepublicreportingburdenforIhiscollectionofinformalionisestimatedtoaverage0.25hoursperresponseforregistrationaclivitiesand0.25hoursperreregislrationandspecialreviewactivities,indud'lngtimeforreafmgtheinstructionsandcompletingthenecessaryforms.SendcommentsregardingtheburdenesOmateoranyotheraspectofthiscollectionofinfonnation,includingsuggestionsforreducingtheburdento:Director,OPPEInformationManagementDivision(2137),U.S.EnvironmentalProtectionAgency,401MStreet,S.W.,Washington,DC20460.Donotsendthefonntothisaddress.DATAMATRIXDaleAugust20,2009EPAReg.No.lFileSymbol86461-XXXPage1of10Appl"lcanfslRegistranfsName&AddressProductTFHoldingsI,llCP.O.Box1034PlalteCity,MO64079Glyphosate62%ManufacturingConcentraleIngredientGlyphosateGuidelineReferenceNumberGuidelineStudyNameMRIDNumberSubmitterStatusNote830.1550ProductIdentityandComposition47042001AxssUSA,LlCPERM830.1600DescriptionofMaterialsUsedtoProducetheProduct47042001AxssUSA,LLCPERM830.1650DescriptionofFormulationProcess47042001AxssUSA,LlCPERM830.1670DiscussionofFormationofImpurities47042001AxssUSA,llCPERM830.1750CertifiedLimits47042001AxssUSA,LlCPERM830.1800EnforcementAnalyticalMethod47042001AxssUSA,LlCPERM830.1900SubmiltalofSamples1830.6302Color47042002AxssUSA,LlCPERM830.6303PhysicalSlate47042002AxssUSA,LLCPERM830.6304Odor47042002AxssUSA,LLCPERM830.6314Oxidation!Reduclion:ChemicalIncompatibility2830.6315Flammability1FlameExtension3830.6316Explodability4830.6317StorageStability47509201AxssUSA,LlCPERM830.6319..vw,,'Miscibility5...Signature..,"...NameandTitleDateXi,,;JaneM.Miller,Agent08/20/2009B""".".EPA,,'P'pee"",,,,""',bI,',bm'""P'pee"",,,AgencyInternalUseCopyBasedonFormApprovedOMBNo,2070-0060UNITEDSTATESENVIRONMENTALPROTECTIONAGENCY401MStreet,S.W.WASHINGTON,D.C.20460PaperworkReductionActNotice:Thereportingburdenforthiscollectionofinformationisestimaledtoaverage0.25hoursperresponseforregislrationand0.25hoursperreregistrationandspecialreviewincludingtimeforreadingtheinstructionsandcompletingthenecessaryforms.SendcommentsregardingtheburdenestimateoranyolheraspectofIhiscolleclionofinformation,includingsuggestionsforreducingtheburdento:Director,OPPEInformationManagementDivision(2137),U.s.EnvironmentalProteClionAgency,401MStreet,S.w.,Washington,DC20460.Donotsendtheformtothisaddress.DATAMATRIXDateAugust20,2009EPAReg.No.lFileSymbol86461-XXXIPage2oftoApplicant'sfRegistrant'sName&AddressProductTFHoldingsI,LLCP.O.Box1034PlatteCity,MO64079Glyphosate62%ManufacturingConcentrateIngredientGlyphosateGuidelineReferenceNumberGuidelinestudyNameMRIDNumberSubmitterStatusNote830.6320CorrosionCharacteristics47509201AxssUSA,LLCPERM830.6321DieleclricBreakdownVoltage6830.7000pH47042002AxssUSA,LLCPERM830.7100Viscosity47042002AxssUSA,LLCPERM830.7300Density47042002AxssUSA,LLCPERM870.1100AcuteOralToxicityCite-AllPAY870,1200AcuteDermalToxicityCHe-AIiPAY870,1300AcuteInhalationToxicityCile-AIIPAY870.2400AcuteEyeIrritationCHe-AIiPAY870.2500AcuteDennallrrilationCite-AllPAY870.2600SkinSensitizationCite-AllPAYThefollowingcompanieshavebeensentoffer10paylellers:8ASFCorporationPAYResearchTrianglePark,NCSignature./....NameandTitleD,'"'.•1'<\NlJ,L-JaneM.Miller,Agent08120/2009BasedonEPAForri!is,!}7)EleclronicandPaperversionsavailable.onlyPaperversion,AgencyInternalUseCopy.(...,,_....BasedonFormApprovedOMBNo.2070·0060UNITEDSTATESENVIRONMENTALPROTECTIONAGENCY401MStreet,S.W.WASHINGTON,D.C.20460PaperworkReductionActNotice:Thepublicreportingburdenfor1hiscollectionofinfonnationisestimatedtoaverage0.25hoursperresponseforregistrationactivitiesand0.25hoursperreregistrationandspecialreviewactivities,includingtimeforreadingtheinstructionsandcompletingthenecessaryfonns.Sendcommentsregardingtheburdenestimateoranyotheraspectofthiscoltectionofinformation,includingsuggestionsforreducingtheburdento'.Director,OPPEtnformationManagementDivision(2137),U.S.EnvironmentalProtectionAgency,401MStreet,SW.,Washington,DC20460.Donotsendtheformtothisaddress,DATAMATRIXDateAugust20,2009EPAReg.NoJFileSymbol86461-XXXIPage3of10Applicant'sJRegistrant's Name&AddressProductTFHoldingsI,llCP.O.Box1034PlatteCity,MO64079Glyphosate62%ManufacturingConcentrateIngredient GlyphosateGuidelineReferenceNumberGuidelineStudyNameMRIDNumberSubmitterStatusNoteTheScottsCompanyPAYMarysville,OH43041NufarmAmericas,tnc.PAYBurrRidge,tlFMCCorp.PAYPhiladelphia,PAE.!. DUPontDeNemoursPAYNewark,DEMakhteshim-AganofNorthAmericaPAYRaleigh,NCMonsantoCo.PAYWashington,DCSprayDriftTaskForcePAYWashington,DC20006·..,BASFCorp.PAY.·••>-.,ResearchTriangtePark,NC·OutdoorResidentialTaskForce.'"PAYWashington,DC20005.......Signature:".0;,r'""0":)NameandTitleDate·'0;,"".r:,,;:,;,:.4·00JaneM,Miller,Agen!08J20f2009.·0"BasedonEPAFOnn(70-'3I.(9-97)BectronicandPaperversionsavailable.SubmitonlyPaperversion.AgencyInternalUseCopyBasedonFormApprovedOMBNo.2070-0060UNITEDSTATESENVIRONMENTALPROTECTIONAGENCY401MStreet,S.W.WASHINGTON,D.C.20460PaperworkReductionActNotice:Thepublicreportingburdenforthiscollectionofinformationisestimatedtoaverage0.25hoursperresponseforregistrationactivitiesand0.25hoursperreregistrationandspecialreviewactivities,includingtimeforreadingtheinstructionsandcompletingthenecessaryforms.Sendcommentsregardingtheburdenestimateoranyolheraspectofcollectionofinformation,Includingsuggestionsforreducingtheburdento:Director,OPPEInformationManagementDivision(2137),U.S.EnvironmentalProtectionAgency,401MStreet,S.w.,Washington,DC20460.00notsendtheformtothisaddress.DATAMATRIXDateAugust20,2009EPAReg.No.lFileSymbol86461-XXXPage4of10Applicant's/Registrant'sName&AddressProductTFHoldingsI,LLCP.O.Box1034PtatteC'lty,MO64079Glyphosate62%ManufacturingConcentratetngredientGlyphosateGuideHneReferenceNumberGuidelinestudyNameMRIDNumberSubmitterStatusNoteAgriculturalRe-EntryTask.ForcePAYWashington,DC20005RitterChemicatLLCPAYWashington,DCDrexelChemicalCo.PAYMemphis,TNtndustriaProdottiChimiciPAYWashington,DCAlbaugh,Inc.PAYValdosta,GAValentUSAPAYWatnutCreek.,CADowAgrosciencesLLCPAY"tndianapolis,IN...:----,CheminovaInc.PAY.,'-:-",,"Arlington,VAChemicalProductsTechnologiesPAY","".""Cartersvitte,GA,·,".".Signature:·7::::,·,''',::".'"lL..-NameandTitleDate,JaneM.Miller,Agent08120/2009BasedonEPAForm8570j5(97)Elecron'icandPaperversionsavailabte.Submitonlypaperversion.AgencyInternatUseCopy\.JBasedonFormApprovedOMBNo.2070-0060UNITEDSTATESENVIRONMENTALPROTECTIONAGENCY401MStreet,S.W.WASHINGTON,D.C.20460PapelWorkReductionActNotice;Thepublicreportingburdenforthiscollectionofinformalioniseslimatedtoaverage0.25hoursperresponseforregistrationactivitiesand0.25hoursperreregistrationandspecialreviewactivilies,includingtimeforreadingtheinstructionsandcompletingthenecessaryforms.Sendcommentsregardingtheburdenestimateoranyolheraspectofcollectionofinformation,includingsuggestionsforreducingtheburdento:Director,OPPEInformationManagementDivision(2137),U.S.EnvironmentalProteclionAgency,401MStreet,S.w.,Washington,DC20460.Donotsendtheformtothisaddress.DATAMATRIXDateAugust20,2009EPAReg.No.lFileSymbol86461-XXXPage5of10Applicant'sIRegistrant'sName&AddressProductTFHoldingsI,LLCP.O.Box1034PlatleCity,MD64079Glyphosate62%ManufacturingConcentrateIngredientGlyphosateGukielineReferenceNumberGuidermeStudyNameMRIDNumberSubmitterStatusNoteNufarmInc.PAYBurrR·ldge,ILNationsAGIIPAYSeatlle,WARohm&HaasCo.PAYPhiladelphia,PAHelmAgroUS,Inc.PAYMemphis,TNResidentialExposureJointVenlurePAYWashington,DCAgriculluralHandlersExposureTFPAYMacon,MOMeyCorporationPAY,Washington,DC:'.:.--.LlbertasNow,Inc.",PAY".,,,Annapolis,MD,".,GreenLightCo.PAY......".SanAntonio,TX,..,.....".Signatur&.,.""iI\A\/NameandTilleDate"..".,.,"JaneM.Miller,Agent0812012009BasedonEPAForm8570-35r7J\,lectronicandPaperversionsavailable.SubmHonlyPaperversion.AgencyInternalUseCopyI'-./BasedonFormApprovedOMBNo.2070-0060UNITEDSTATESENVIRONMENTALPROTECTIONAGENCY401MStreet,S.W.WASHINGTON,D.C.20460PaperworkReductionActNotice:Thepublicreportingburdenforthiscollectionofinformationisestimatedtoaverage0.25hoursperresponseforregistrationactivitiesand0.25hoursperreregistrationandspecialreviewactivities,inctudingtimeforreadingtheinstructionsandcompletingthenecessaryforms.Sendcommentsregardingtheburdenestimateoranyotheraspectofcollectionofinformation,includingsuggestionsforreducingtheburdento:Director,OPPEInformationManagementDivision(2137),U.S.EnvironmentatProtectionAgency,401MStreet,S.W.,Washington,.DC20460.Donotsendtheformtothisaddress.DATAMATRIXDateAugust20,2009EPAReg.No.fFileSymbot86461·XXXPage6of10Appticant'sJRegistrant'sName&AddressProductTFHoldingsI,llCP.O.Box1034PtatteCity,MO64079Glyphosate62%ManufacturingConcentrateIngredientGlyphosateGuidelineReferenceNumberGuidelineStudyNameMRIDNumberSubmitterStatusNotePBt/GordonCorp.PAYKansasCity,MOVoluntaryPurchasingGroupPAYBonham,TXChemsicoPAYSLlouis,MOlovetandProducts,tnc.PAYGreetey,COHi-YietdChemicalCo.PAYBonham,TXControlSolutions,tnc.PAYPasadena,TXCedarChemtcatCorpPAY.,.Memphis,TN:.NichinoAmerica,tnc.PAY..."....Wilmington,DE'"_"wFIFRAEndangeredSpeciesTFPAY'"........Washington,DC..·................. ..Signaturo:...·......:X..tvNameandTitleDate..·.JaneM.Miller,Agent08/2012009B",d"EPAF"mro,,,,9.97)EI,a'o)';,bodP'pe""';'"",II,bI,S",mll"'yAgencytnternalUseCopyBasedonFormApprovedOMBNo.2070-0060UNITEDSTATESENVIRONMENTALPROTECTIONAGENCY401MStreet,S.W.WASHINGTON,D.C.20460PaperworkReductionActNotice:Thepubllcreportingburdenforthiscollectionofinformationisestimatedtoaverage0.25hoursperresponseforregistrationactivitiesand0.25hoursperreregistrationandspecialreviewactivities,includingtimeforreadingIheinstructionsandcompletingthenecessaryforms.SendcommentsregardingtheburdenestimateoranyotheraspectofcoUectionofinformation,includingsuggeslionsforreducingIheburdento:Director,OPPEInformationManagementDivision(2137),U.S.EnvironmentalProtectionAgency,401MStreet,S.W.,Washington,DC20460.Donotsendtheformtothisaddress.DATAMATRIXDateAugust20,2009EPAReg.No.fFileSymbol86461-XXXIPage7of10Applicant'S/Registrant'sName&AddressProductTFHoldingsI,llCP.O.Box1034PlatteCity,MO64079Glyphosate62%ManufacturingConcentrateIngredientGlyphosateGuidelineReferenceNumberGuidelineStudyNameMRIDNumberSubmitterStatusNotePhoenixEnvironmentalCarePAYValdosta,GADeangeloBrothersPAYHockessin,DEAgriPackaging&logisticsPAYSardis,MSAdjuvantsUnlimited,Inc.PAYBrookfield,CT06804GenericEndangeredSpeciesTFPAYWashington,DC-AganChemMfg.Ltd.PAYRaleigh,NCBASFSparksLlCPAY-"'--ResearchTrianglePark,NC"-PRARegistrationsllCPAY.--.Voorhees,NJ"-RedEagleInternationalLLCPAY-----"'_w-Hockessin,DE-..--."-..- - -.-,.-.-'-:-y--:-:\;"Signature,"',,:NameandTitleDateJaneM.MillerAoent08/20/2009(BasedonFormApprovedOMBNo.2070-0060UNITEDSTATESENVIRONMENTALPROTECTIONAGENCY401MStreet,S.W.WASHINGTON,D.C.20460PaperworkReductionActNotice:Thepublicreportingburdenforthiscollectionofinformationisestimaledtoaverage0.25hoursperresponseforactivitiesand0.25hoursperreregistrationandspec'latreviewactivilies,includingOmeforreadingtheinstructionsandcompletingthenecessaryforms.Sendcommentsregard'lngtheburdenestimateoranyotheraspectofcollectionofinformation,includingsuggestionsforreducingtheburdento:Director,OPPEInformationManagementDivision(2137),U.S.EnvironmentalProtectionAgency,401MStreet,S.W.,Washington,DC20460.DonotsendIheformtothisaddress.DATAMATRIXDateAugust20,2009EPAReg.No.!FileSymbol86461-XXXIPage80f10Applicant'sIRegistrant'sName&AddressProductTFHoldingsI,LLCP.O.Box1034PlatteCity,MO64079Glyphosate62%ManufacturingConcentrateIngredientGlyphosateGuidelineReferenceNumberGuidelineStudyNameMRIONumberSubmitterStatusNoteRepar-GlyphoLLCPAYWashington,DCFalconLabLLCPAYGreenwich,CTAlligareLLCPAYGigHarbor,WABayerCropscienceLPPAYResearchTriangtePark,NCWinfieldSotutions,LLCPAYSt.Paul,MNHelenaChemicalCo.PAYMemphis,TNSyngentaCropProtectionPAYGreensboro,NCMonsantoPAY··.....Washington,DC·..-.BASFSparks.....PAYResearchTrianglePark,NCSignature-:--..•.NameandTilleDate•••:..;<'vi:.):JaneM.Miller,Agent0812012009"..B,,,,"EPAFo,,"85[3"'\9.971E"ltioo"',,,P,p""rni",''''',bI,.S,bmitoo'yP'p""rniooAgencyInternalUseCopyjBasedonFormApprovedOMBNo.2070-0060UNITEDSTATESENVIRONMENTALPROTECTIONAGENCY401MStreet,S.W.WASHINGTON,D.C.20460,PaperworkReductionActNotice:Thepublicreportingburdenforthiscollectionofinformationisestimatedtoaverage0.25hoursperresponseforregistrationactivitiesand0.25hoursper,reregistrationandspecialreviewactivHies,includingtimeforreadingtheinstructionsandcompletingthenecessaryforms.Sendcommentsregardingtheburdenestimateoranyotheraspectofcollectionofinformation,includingsuggestionsforreducingtheburdento:Director,OPPEInformationManagementDivision(2137),U.S.EnvironmenlalProtectionAgency,401MStreet,S.w.,Washington,DC20460.Donot sendtheformtothisaddress.DATAMATRIXDateAugust20,2009EPAReg.No.!FileSymbol86461-XXXPage9of10Applicant'sIRegistrant'sName&AddressProductTFHolcl"mgsI,LLCP.O.Box1034PlatteCity,MO64079Glyphosate62%Manufactur·mgConcentrateIngredientGlyphosateGuidelineReferenceNumberGuidelineStudyNameMRIDNumberSubmitterStatusNoteCheminovaNSPAYArlington,VAPRARegistrations,LLCpAYVoorhees,NJAxssUSA,LLCPAYBrookfield,CT,,-:",,, ,.-.-.,"',",.,,,..,,."',",,"","".\"'"""'(NameandTitleDateSignalure,VJ.--,JaneM.Miller,Agent08/20/2009BasedonEPAForm/57(S:97)ElectronicandPaper versionsavailable.SubmitonlyPaperversion.AgencyInternalUseCopy\..../DataMatrixFootnotes1.Notrequiredatthistimeforthisend-useproduct.2.Notapplicable.Neitherthetechnicalgradeactiveingredientnortheinertingredientsareconsideredstrongoxidizingorreducingagents.3.Notapplicable.Theproductdoesnotcontaincombustibleliquids.4.Notapplicable.Neitherthetechnicalgradeactiveingredientnortheinertingredientsareconsideredaspotentiallyexplosive.5.Notapplicable.Theproductisnotintendedtobedilutedwithapetroleumsolvent.6.Notapplicable.Theproductisnotintendedforusearoundelectricalequipment.10Fonn Approve B 0.20 d OM N 70-00 60

# ~'l UNITED STATES ENVIRONMENTAL PROTECTION AGENCY



# . 

# _' 401 M Street, S.W

. WASHINGTON, D.C. 20460

Paperwork Reduction Act Notice: The public reporting burden forthis collection of infonnation is estimated to average 125 hours per response for registration and 0.25 hours per response for reregistration and special review activities. including lime for reading the instructions and completing the necessary fonns. Send comments regarding burden estimate or any other aspect of this collection ofinfonnation, including suggestions for reducing the burden to: Director, OPPE Infonnation Management DiviSion (2 t37), U.S. Environmental Protection Agency, 40t M Street, S,W., Washington, DC 20460. Do not send the completed form to th'l$ address.

Certification with Respect to Citation of Data

ApplicanfslRegistrant's Name, Address, and Telephone Number EPA Registration Number/File Symbol TF Holdings I, LLC P.O. 80x 1034 Platte City, MO 64079 86461-XX

Active Inoredient(s) and/or reoresentative test comoound(s) D,to Glyphosate August 25. 2009

General Use Pattem(s) (list all those claimed for this product usinQ 40 CFR Part t58) Product Name Terrestrial Food, Terrestrial Non-Food, Domestic Outdoor Glyphosate 62% Manufacturing Concentrate

NOTE: If your product is a 100% repackaging of anolher purchased EPA-registered product labeled for all the same uses on your label, you do not need to submilthis fonn. 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 DATASUPPORT (Check one method only) 

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

## [?J I am using the selective method of support {or**c~e-all** option

a list of companies sent offers of compensation (the Data Matrix fonn under the selecUve method), and have included with this form a should be used for this purpose). completed Ijst of data requirements (the Data Matrix fonn must be used).

SECTION II: GENERAL OFFER TO PAY

IRequired if using the**c~e-all** method or when using the cite-all option under the selective method to satisfy one or more data requiremenls) 

## [?J I hereby offer and agree to pay compensalion, to olher persons, with regard to the approval of this application, 10 the extent required by FIFRA.

SECTION III: CERTIFICATION

I certrry that this application for registralion, this form for reregistration, or this Data-Call-In response is supported by all data submitted or cited in the application for**reg~tration,** the fonn for reregistration, or the Data-Call-In response. In addition, if the cite-all option or cae-all option under the selective method is indicated in Section I, Ihis application is supported by all data in the Agency's files that (1) concem the properties or effects of this product or an identical or substantially Similar product, or one or more of the ingredients in this product; and (2) is a type of data that would be required to be submitted under the data requirements in effect on the dale of approval of this application if the applicalion sought the initial registration of a product ofidenlical or similar composition and

uses.

I certify that for each exclusive use study cfled in support of this registration or reregistration, that I am the original data submFtter or that I have obtained the written permission of the original data submitter to cite that study.

I certify that for each study cited in support of this registration or reregistration that is not an exclusive use study, either: (a) I am the Original data submrtter; (b) I have obtained the permission oftlle original data submitter to use the study in support ofthis application; (c) all periods of eligibiJjty ro!"'

, 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 stUC;Y'all(\ have offered 

## m to pay compensation to the extent required by sections 3{c){1)(F) and/or 3(c)(2)(8) of FIFRA; and (Ii) to commence negotialions to detcmnirE the amount and terms of compensalion, 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 compensalion**anJ,;JGe~Ce** ofthelr delfvery in accordance with sections 3(c)(t)(F) and/or 3(c)(2)(B) of FIFRA are available and will be submitted to the Agency upon request. ShoUlb I fail t6,Pr,)duCt} such evidence to the Agency upon request, I understand that the Agency may initlate action to deny, cancel or suspend the registrafidn:of**,'n~** product in Qlllformity with FIFRA. ,',

, , 

### ,

- . , "
I certify that the statements I have made on thiS form and all attachments to it are true, accurate, and cOfTIp!eJp,.**,1)acknOwl~ds;e** that any knowingly false or misleading statement may be punishable by fine or Imprisonment or both under applicable law. ,), ,

, '


## . '/ Signature

M 

# mJ-.---- Oate Typed or Printed Name and Tille 

## I IA August 25, 2009 Jane M. Miller, Agent ">

,

EPA Form 8570-341' ElectroniC and Paper versions available. Submit only Paper version.t><<-4"h\",-,I4V>-B___''''M___..__'''____''_'''_"''________'_________-',,,,,,-.=-,,--,"'-------'''·_-,''c","",-."0-."="''',''-"'"_'.""=-.--"--_:_-,-.=-"--_""=__,7.=,,",',"'c,"---,.0'-,,--'