EPA Registration Number 86461-2 
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1

III 

009285062 
2

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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 

Product 

L. 

Chemistry 

Kutney, Chemist 

Team 

L~ L 

't-I,,\""-IO 

~ 

\ (LA-... ~p q/lIA/!O 

Technical Review BranchIRD (7505P) b '\PTO: 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. 
3

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-
4

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-
5

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-
6

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 • 
7

CONFIDENTIAL APPENDIX: 

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

carcinogenic impurities: 

-6-

*Manufacturing process information may be entitled to confidential treatment*
8

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] 
9

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 of3 
10

EPA 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 
11

) 

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 8R 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 R09, 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. 
12

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-
13

) 

CONFIDENTIAL APPENDIX: 

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

-3-

*Manufacturing process information may be entitled to confidential treatment*
14 *Confidential Statement of Formula may be entitled to confidential 
15

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

ISB'S Front-end PRlA Completeness Screen 

Draft 3; 10/25107 

EPA Rcceipt Date: AUG 26 2009 EPA Reg. Number: P6Lf61-t: 

•.. - ,- ... ,,,( ,,:, " ·.·".r •. "I"~1i __ ~i",·.-oo"''''J'"'' - yeS'( ]\fif' . Check;r;;i~tJI!IJ\i'::""< ,~, 'c"ii':"'" , . ".' _."" ~, " " , .. _'.':."',,',' .. _'V_ .. - .h'_ • . ", . 

I 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· 

27) Included jn the Submission Package? X .. 

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

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

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

Submission Package? X - 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.. 

--_ .. -._._--- --- ---- ---_._-------------- --- - -------.. -., ---------~-.. ------------------
16

) 

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' 

I 

Phone: 30t:, !>&")'7 Division: _K_D __ _ 

Date: ~<~{~fi~O+/I~D ____________________ ~ ______ _ 

Created August 14,2008 
17

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 
18

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. 
19

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 

'''''' 

, " , , 

, , , " , , , 

" 

, , , , 

, , , , 

" , , " " , 

" , " , , " 

Manufactured .. , , by: 

TF Holdings I, LLC 

P.O. Box 1034 

NET CONTENTS: __ GALzl.:_,,_. _ LB.13? : 

Platte Cily, MO 64079 " , , , , , , 

. " " , " ) , 

1 
20

) 

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 

, ' , , :" 2 
21

nurseries 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. ",' 

'j j j 

, " , , 

j , j j 3 
22

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. 

'" , '" , 

" , , , , " , . , , " , , , . , , " , , , , " , , , , " , , , , , , , , " , " , , ., , , 

" . , 

.. . . 

. , . , . 4 , ., 
23

) (q.,L 

'f(~i.:-:-

B L~ Q,.-0XC_IJS:C. /.F • ,I _<.~- '-'. -'~'-(~H .. ~<- '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 30th, 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 

""" 

, " , . " 

, , , , , , . , 

" , , , , , . , , , " , , , 

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

, . , , , ;l , , 

, 

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24

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 2007 
25

December 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 
26

/ 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 
27

) 

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 
28

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. 
29

'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 

*Manufacturing process information may be entitled to confidential treatment*
30

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, 
31

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;eIY, . ' , ' , ' 

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.com 
32

Form 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 

" , , , , , . >, " 

" , , , , 

" • 

" . " , , , , " , , , 

,), , 

, , " , 

" , 

-, , , , " , , 

, , " . 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 , 

'--" 

*Product ingredient source information may be entitled to confidential treatment*
33

-' 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 

, " 

. . , 

,,' ) 

'" , 

" , 

'" , 
34

PRlA 2 - 21 Day Content Screen Review Worksheet 

(EPA/OFP Use Only) 

~ 3/23/09 

21 Day Screen Start Date: -,---,ISL--:::.;(;'-"~:';-"--"C>"-<;L-___ -=:---:;--o-. 

Experts In-Processing Signature: --Cc"lS=-Lf'.-=-",:' ___ -:-::- Date 8-~"8-.o9 FeePaid: Yes~ 

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· .• ~. .' . 

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

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

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

I ) 

I 
35

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 
36

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 
37

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; 

4 
38

i 

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 
39

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. 

6 
40

UNITED 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-\ 

Front 

1'£/I.,UUL 

End Processing 

~ 

Staff 

Information Technology & Resources Management Division 
41

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? 

I Risk Mgr. []I] 

\ 0 volpay % Reduction: 

LReceipt 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: 

*Inert ingredient information may be entitled to confidential treatment*
42
43

FEE FOR SERVICE 
44

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 

," , 

" " 

" , , , " , 

" , 

" ", , , , 

" , 
45

. . . 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 

*Product ingredient source information may be entitled to confidential treatment*
46

""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 Toow 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" ~ .f No .f No 

Y" ~M'''' .t Plastic 

No Glass 

* Certif"teation must If wYosW No. p~r If ·Yesw 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 lonamalt 
47

Based on Form A

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

401 M Street, S.W. 

WASHINGTON, D.C. 20460 

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

reregislration and special review activities, indud'lng time for reafmg the instructions and completing the necessary forms. Send comments regarding the burden esOm

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

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

DATA MATRIX 

Dale August 20, 2009 EPA Reg. No.lFile Symbol 86461-XXX 

Appl"lcanfslRegistranfs Name & Address Product 

TF Holdings I, llC P.O. Box 1034 Plalte City, MO 64079 Glyphosate 62% Manufacturing Concentrale 

Ingredient Glyphosate 

Guideline Reference Number Guideline Study Name MRID Number Submitter Stat

830.1550 Product Identity and Composition 47042001 Axss USA, LlC PER

830.1600 Description of Materials Used to Produce the Product 47042001 Axss USA, LLC PER

830.1650 Description of Formulation Process 47042001 Axss USA, LlC PER

830.1670 Discussion of Formation of Impurities 47042001 Axss USA, llC PER

830.1750 Certified Limits 47042001 Axss USA, LlC PER

830.1800 Enforcement Analytical Method 47042001 Axss USA, LlC PER

830.1900 Submiltal of Samples 

830.6302 Color 47042002 Axss USA, LlC PER

830.6303 Physical Slate 47042002 Axss USA, LLC PER

830.6304 Odor 47042002 Axss USA, LLC PER

830.6314 Oxidation! Reduclion: Chemical Incompatibility 

830.6315 Flammability 1 Flame Extension 

830.6316 Explodability 

830.6317 Storage Stability 47509201 Axss USA, LlC PER

830.6319 . . v w,,' Miscibility 

. . . 

Signature 

.. , " .. . 

Name and Title 

Xi ,,; Jane M. Miller, Agent 

B""". ". EPA ,,' P'pee "",,,, ""',bI, ',bm' "" P'pee "",,, Agency Internal 
48

Based on Form A

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

401 M Street, S.W. 

WASHINGTON, D.C. 20460 

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

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

colleclion of information, including suggestions for reducing the burden to: Director, OPPE Information Management Division (2137), U.s. Environmental ProteClion Ag

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

DATA MATRIX 

Date August 20, 2009 EPA Reg. No.lFile Symbol 86461-XXX 

Applicant'sfRegistrant's Name & Address Product 

TF Holdings I, LLC P.O. Box 1034 Platte City, MO 64079 Glyphosate 62% Manufacturing Concentrate 

Ingredient Glyphosate 

Guideline Reference Number Guideline study Name MRID Number Submitter Stat

830.6320 Corrosion Characteristics 47509201 Axss USA, LLC PER830.6321 Dieleclric Breakdown Voltage 830.7000 pH 47042002 Axss USA, LLC PER830.7100 Viscosity 47042002 Axss USA, LLC PER830.7300 Density 47042002 Axss USA, LLC PER

870.1100 Acute Oral Toxicity Cite-All PAY 

870,1200 Acute Dermal Toxicity CHe-AIi PAY 

870,1300 Acute Inhalation Toxicity Cile-AII PAY 

870.2400 Acute Eye Irritation CHe-AIi PAY 870.2500 Acute Dennallrrilation Cite-All PAY 870.2600 Skin Sensitization Cite-All PAY 

The following companies have been sent offer 10 pay lellers: 

8ASF Corporation PAY 

Research Triangle Park, NC 

Signature . / .... Name and Title 

' .• 1'<\ Nl J,L- Jane M. Miller, Agent 

Based on EPA Forri! is,!}7) Eleclronic and Paper versions available. only Paper version, Agency Internal 

. ( . ..,,_ .. . . 
49

Based on Form Ap

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

401 M Street, S.W. 

WASHINGTON, D.C. 20460 

Paperwork Reduction Act Notice: The public reporting burden for1his collection of infonnation is estimated to average 0.25 hours per response for registration activiti

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

coltection of information, including suggestions for reducing the burden to'. Director, OPPE tnformation Management Division (2137), U.S. Environmental Protection Age

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

DATA MATRIX 

Date August20,2009 EPA Reg. NoJFile Symbol 86461-XXX 

Applicant'sJRegistrant's Name & Address Product 

TF Holdings I, llC P.O. Box 1034 Platte City, MO 64079 Glyphosate 62% Manufacturing Concentrate 

Ingredient Glyphosate 

Guideline Reference Number Guideline Study Name MRID Number Submitter Statu

The Scotts Company PAY 

Marysville,OH 43041 

Nufarm Americas, tnc. PAY 

Burr Ridge, tl 

FMC Corp. PAY 

Philadelphia, PA 

E.!. DUPont De Nemours PAY 

Newark, DE 

Makhteshim-Agan of North America PAY Raleigh, NC 

Monsanto Co. PAY 

Washington, DC 

Spray Drift Task Force PAY 

Washington, DC 20006 

· .. , BASF Corp. PAY 

. 

•• · >- . 

, 

Research Triangte Park, NC · 

. Outdoor Residential Task Force '" PAY 

Washington, DC 20005 

.. 

. ... . 

Signature: " . 0;,r'" "0": ) Name and Title 

· · '0;,"" .r:,,;: ,;,: .4 0 0 . Jane M, Miller, Agen! 

· 0 " 

Based on EPA FOnn(70-'3I. (9-97) Bectronic and Paper versions available. Submit only Paper version. Agency Internal 
50

Based on Form Ap

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

401 M Street, S.W. 

WASHINGTON, D.C. 20460 

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

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

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

Washington, DC 20460. 00 not send the form to this address. 

DATA MATRIX 

Date August 20, 2009 EPA Reg. No.lFile Symbol 86461-XXX 

Applicant's/Registrant's Name & Address Product 

TF Holdings I, LLC P.O. Box 1034 Ptatte C'lty, MO 64079 Glyphosate 62% Manufacturing Concentrate 

tngredient Glyphosate 

GuideHne Reference Number Guideline study Name MRID Number Submitter Statu

Agricultural Re-Entry Task. Force PAY 

Washington, DC 20005 

Ritter Chemicat LLC PAY 

Washington, DC 

Drexel Chemical Co. PAY 

Memphis, TN 

tndustria Prodotti Chimici PAY 

Washington, DC 

Albaugh, Inc. PAY 

Valdosta, GA 

Valent USA PAY 

Watnut Creek., CA 

Dow Agrosciences LLC PAY 

" tndianapolis, IN 

... :----, Cheminova Inc. PAY 

., '-:-" , , " Arlington, VA 

Chemical Products Technologies PAY 

" , " ". " , " Cartersvitte, GA · , . " " . 

Signature: , · 7::: : · , ''',: :" . '" lL..- Name and Title 

, Jane M. Miller, Agent 

Based on EPA Form 8570j5 (9 7) Elec ron'ic and Paper versions availabte. Submit only paper version. Agency Internat U

\ .J 
51

Based on Form Ap

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

401 M Street, S.W. 

WASHINGTON, D.C. 20460 

PapelWork Reduction Act Notice; The public reporting burden for this collection of informalion is eslimated to average 0.25 hours per response for registration activit

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

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

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

DATA MATRIX 

Date August 20, 2009 EPA Reg. No.lFile Symbol 86461-XXX 

Applicant'sIRegistrant's Name & Address Product 

TF Holdings I, LLC P.O. Box 1034 Platle City, MD 64079 Glyphosate 62% Manufacturing Concentrate 

Ingredient Glyphosate 

Gukieline Reference Number Guiderme Study Name MRID Number Submitter Statu

Nufarm Inc. PAY 

Burr R·ldge, IL 

NationsAG II PAY 

Seatlle,WA 

Rohm & Haas Co. PAY 

Philadelphia, PA 

Helm Agro US, Inc. PAY 

Memphis, TN 

Residential Exposure Joint Venlure PAY 

Washington, DC 

Agricullural Handlers Exposure TF PAY 

Macon, MO 

Mey Corporation PAY 

, Washington, DC 

: ' .: 

.--. Llbertas Now, Inc. " , PAY 

. , , " , 

, "., Annapolis, MD 

Green Light Co. PAY 

, 

.. 

. ... " . San Antonio, TX . . , . . . . . " . 

Signatur& . , . " "i I\A \/ Name and Tille 

" , . . " . ., " Jane M. Miller, Agent 

Based on EPA Form 8570-35 r7J\, lectronic and Paper versions available. SubmH only Paper version. Agency Internal U

I 

'-./ 
52

Based on Form Ap

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

401 M Street, S.W. 

WASHINGTON, D.C. 20460 

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

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

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

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

DATA MATRIX 

Date August 20, 2009 EPA Reg. No.fFile Symbot 86461·XXX 

Appticant'sJRegistrant's Name & Address Product 

TF Holdings I, llC P.O. Box 1034 Ptatte City, MO 64079 Glyphosate 62% Manufacturing Concentrate 

Ingredient Glyphosate 

Guideline Reference Number Guideline Study Name MRID Number Submitter Statu

PBt/Gordon Corp. PAY 

Kansas City, MO 

Voluntary Purchasing Group PAY 

Bonham, TX 

Chemsico PAY 

SL louis, MO 

lovetand Products, tnc. PAY 

Greetey, CO 

Hi-Yietd Chemical Co. PAY 

Bonham, TX 

Control Solutions, tnc. PAY 

Pasadena, TX 

Cedar Chemtcat Corp PAY 

. ,. Memphis, TN 

: . Nichino America, tnc . PAY . .. " . 

. .. Wilmington, DE '" _"w 

FIFRA Endangered Species TF PAY 

'" .. 

. . 

.. .... Washington, DC · .. .. . .. ... . .. .. .. .. 

Signaturo :. .. · .. 

. ... : X .. tv .. Name and Title 

. · Jane M. Miller, Agent 

B",d" EPA F"m ro,,,, 9.97) EI,a'o)';, bod P'pe""';'" ",II,bI, S",mll "'y Agency tnternal U
53

Based on Form Ap

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

401 M Street, S.W. 

WASHINGTON, D.C. 20460 

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

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

coUection of information, including suggeslions for reducing Ihe burden to: Director, OPPE Information Management Division (2137), U.S. Environmental Protection Age

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

DATA MATRIX 

Date August 20, 2009 EPA Reg. No.fFile Symbol 86461-XXX 

Applicant'S/Registrant's Name & Address Product 

TF Holdings I, llC P.O. Box 1034 Platte City, MO 64079 Glyphosate 62% Manufacturing Concentrate 

Ingredient Glyphosate 

Guideline Reference Number Guideline Study Name MRID Number Submitter Status 

Phoenix Environmental Care PAY 

Valdosta, GA 

Deangelo Brothers PAY 

Hockessin, DE 

Agri Packaging & logistics PAY 

Sardis, MS 

Adjuvants Unlimited, Inc. PAY 

Brookfield, CT 06804 

Generic Endangered Species TF PAY 

Washington, DC 

- Agan Chem Mfg. Ltd. PAY 

Raleigh, NC 

BASF Sparks LlC PAY 

-

"' -- Research Triangle Park, NC " 

- PRA Registrations llC PAY 

.--. 

Voorhees, NJ " -

Red Eagle International LLC PAY 

----

- "'_ w 

- .. 

-

- Hockessin, DE 

-

. " - . . 

.-,.-. 

- - -

Signature, "',,: 

-'-: -y--:-: \;" Name and Title 

Jane M. Miller Aoent 

( 
54

Based on Form A

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

401 M Street, S.W. 

WASHINGTON, D.C. 20460 

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

reregistration and spec'lat review activilies, including Ome for reading the instructions and completing the necessary forms. Send comments regard'lng the burden estim

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

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

DATA MATRIX 

Date August 20, 2009 EPA Reg. No.!File Symbol 86461-XXX 

Applicant'sIRegistrant's Name & Address Product 

TF Holdings I, LLC P.O. Box 1034 Platte City, MO 64079 Glyphosate 62% Manufacturing Concentrate 

Ingredient Glyphosate 

Guideline Reference Number Guideline Study Name MRIO Number Submitter Statu

Repar-Glypho LLC PAY 

Washington, DC 

Falcon Lab LLC PAY 

Greenwich, CT 

Alligare LLC PAY 

Gig Harbor, WA 

Bayer Cropscience LP PAY 

Research Triangte Park, NC 

Winfield Sotutions, LLC PAY 

St. Paul, MN 

Helena Chemical Co. PAY 

Memphis, TN 

Syngenta Crop Protection PAY 

Greensboro, NC 

Monsanto PAY 

· · . . .. . Washington, DC · .. 

- . 

.. ... BASF Sparks PAY 

Research Triangle Park, NC 

Signature -:--..• . Name and Tille 

••• : .. ; <'vi:.) : Jane M. Miller, Agent 

" .. 

B,,,, "EPA Fo,," 85[3"'\9.971 E"ltioo"',,, P,p" "rni", ''''',bI,. S,bmit oo'y P'p" "rnioo Agency Internal 

j 
55

Based on Form Ap

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

401 M Street, S.W. 

WASHINGTON, D.C. 20460 

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

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

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

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

DATA MATRIX 

Date August 20, 2009 EPA Reg. No.!File Symbol 86461-XXX 

Applicant'sIRegistrant's Name & Address Product 

TF Holcl"mgs I, LLC P.O. Box 1034 Platte City, MO 64079 Glyphosate 62% Manufactur·mg Concentrate 

Ingredient Glyphosate 

Guideline Reference Number Guideline Study Name MRID Number Submitter Statu

Cheminova NS PAY 

Arlington, VA 

PRA Registrations, LLC pAY 

Voorhees, NJ 

Axss USA, LLC PAY 

Brookfield, CT 

, ,-: " 

, 

, 

, , 

.-.-. , 

"' 

,", . , 

, , 

.. , , . 

"' , " , , " " , " " Signalure , . \"'" " "'( Name and Title 

, V J.-- Jane M. Miller, Agent 

Based on EPA Form/57 (S:97) Electronic and Paper versions available. Submit only Paper version. Agency Internal U

\..../ 
56

Data Matrix Footnotes 

1. Not required at this time for this end-use product. 

2. Not applicable. Neither the technical grade active ingredient nor the inert ingredients are considered strong oxidizin

3. Not applicable. The product does not contain combustible liquids. 

4. Not applicable. Neither the technical grade active ingredient nor the inert ingredients are considered as potentially e

5. Not applicable. The product is not intended to be diluted with a petroleum solvent. 

6. Not applicable. The product is not intended for use around electrical equipment. 

10 
57

Fonn Approve d OM B N 0.20 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. 
58
59

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___ 

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___ 

.. 

__ 

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__ __ ''_'''_"''_ __ ___ __ ' __ ____ 

-',,,,,,-.=-,,-- ,"'-- ---- -'''·_-,''c","",-. "0-."="''',''-"'"_'. ""=-.- -"-- _:_-,-.=-" --_ ""= __ ,7.=,,",' ,"'c,"- 

*Confidential Statement of Formula may be entitled to confid