EPA Registration Number 85678-15 
> i

Material Sent for Dat a Extraction

Reg #

Description:

Material(s) Sen t to Dat a Extraction Contractors :

New Stamped Label Date d

D Notificatio n Dated

New CSF(s ) Dated

D Other :

Decision #:

Other Action/Comments :

Attach this coversheet to the top of the material o r jacket. I t

must b e well organized and clipped together, NOT STAPLED.

Then give the materia l wit h this coversheet t o staff i n the

Information Services Center (Roo m S-4900) .

Reviewer: Mind y Ondis h

Phone: 703-605-072 3 Division : RD/P M Team 25

Date:

1
U.S. ENVIRONMENTAL PROTECTION AGENCY

Office of Pesticide Programs

Registration Division (7505P)

Ariel Rios Building

1200 Pennsylvani a Ave., NW

Washington, D.C. 20460

NOTICE OF PESTICIDE:

X Registratio n

Reregistration

(under FIFRA, as amended)

EPA Registration

Number:

85678-15

Date of Issuance:

MAY 1 8 2011

Term of Issuance: Unconditional

Name of Pesticide Product:

Tribufos 6

Name and Address of Registrant (include ZIP Code):

RedEagle International , LLC

1925 Eas t Edgewood Drive , Suite 105

Lakeland, FL 33803

c/o Wagner Regulator y Associates, Inc .

P.O. Box 640

Hockessin, DE 19707-0640

Note: Changes in labeling differing in substance from that accepted in connection with this registration must be submitted to and accepted by the

Registration Division prior to use of the label in commerce. I n any correspondence on this product always refer to the above EPA registration

number.

On the basis of information furnished by the registrant, the above named pesticide is hereby registered/reregistered under the Federal Insecticide,

Fungicide and Rodenticide Act. Registration is in no way to be construed as an endorsement or recommendation of this product by the Agency. I n

order to protect health and the environment, the Administrator, on his motion, may at any time suspend or cancel the registration of a pesticide in

accordance with the Act. Th e acceptance of any name in connection with the registration of a product under this Act is not to be construed as giving

the registrant a right to exclusive use of the name or to its use if it has been covered by others.

This product is registered in accordance with FIFRA provided that you:

1. Submi t and/or cite all data required for registration review/reregistration of your product when

the Agency requires all registrants of similar products to submit data.

2. Submi t one-year Storage Stability (Guideline 830.6317 ) and Corrosion Characteristics

(Guideline 830.6320 ) studies within eighteen (18 ) months from the date of this notice .

The Basic Confidential Statement o f Formula (CSF) dated March 17, 2011 is acceptable.

A stamped copy of the label is enclosed for your records. Submi t one (1) copy of the revised final

printed label before you release the product for shipment. Product s shipped after eighteen (18 )

months from the date of this notice must bear the new revised label. I f these conditions are not

complied with, the registration will be subject to cancellation i n accordance with FIFRA §6(e). You r

release for shipment of the product constitutes acceptance of these conditions.

If you have any questions, please contact Mindy Ondish at (703)605-0723 or at ondish.mindy@epa.gov.

Signature of Approving Official:

Kable Bo Davis

Product Manager 25

Herbicide Branch

Registration Division (7505P)

Date:

MAY 1 8 2011

EPA Form 8570-6

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85678.15.20110512.V1 Tribufos 6 Label with EPA comments

Initial EPA Registration

Tribufos 6

For fast and effective cotton defoliation.

ACTIVE INGREDIENT:

Tribuphos: S,S,S-Tributyl phosphorotrithioate.

OTHER INGREDIENTS: ,

TOTAL:

ACCEPTED

MAY 1 8 2011

Under th e Federa l Insecticide , Fungicide, and Rodenticide Act

as amended , fo r th e pesticid e

registered under /

EPA Reg. N " '

70.5%

29.5%

100.0%

Contains Petroleum Distillates .

Contains 6 Ibs tribufos: S,S,S-Tributy l phosphorotrithioat e pe r U.S. gallon.

STOP - READ THE LABEL BEFORE USE

KEEP OUT OF REACH OF CHILDREN

DANGER PELIGR O

Si usted no entiende la etiqueta, busque a alguien para que se la explique a usted en detalle.

(If you do not understand the label, find someone to explain it to you in detail.)

FIRST AID

CONTAINS AN ORGANOPHOSPHATE THAT INHIBITS CHOLINESTERASE

IF IN EYES: Hold eye open and rinse slowly and gently with water for 15-20 minutes.

Remove contact lenses, if present, after the first 5 minutes, then continue rinsin g

eye.

Call a poison control center or doctor for treatment advice .

IF ON SKIN OR

CLOTHING:

Take off contaminated clothing .

Rinse skin immediately with plenty of water for 15-20 minutes .

Call a poison control center or doctor for treatment advice.

IF SWALLOWED: Immediately cal l a poison control center or doctor for treatment advice.

Do not induce vomiting unles s told to do so by a poison control center or doctor.

Do not give any liquid to the person.

Do not give anything by mouth to an unconscious person.

IF INHALED: Move person to fresh air.

If person is not breathing, call 911 or an ambulance, then give artificial respiration ,

preferably mouth-to-mouth if possible.

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

FOR CHEMICAL EMERGENCY: Spill, leak, fire, exposure, and accident call CHEMTREC 1-800-424-9300 .

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

treatment.

Note To Physician: Contains petroleum distillates. Vomiting may cause aspiration pneumonia. Probabl e

mucosal damage may contraindicate th e use of gastric lavage. This product inhibit s cholinesterase resulting

in stimulation of the central nervous system, the parasympathetic nervous system and the somatic motor

nerves. Poisoning with this product also results in cardiovascular and respiratory symptoms which must be

treated as separate pathological entities apart from the cholinergic effects.

Use atropine sulfate to reverse cholinergic symptoms; maintain a systematic, symptomatic treatment of the

cardiovascular and respiratory effects, even though the cholinergic symptoms have ceased. Do not give

central nervous system depressants. Watch for pulmonary edema, which may develop in serious cases of

poisoning even after 1 2 hours. The use of oxygen is recommended in case of respiratory distress.

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85678.15.20110512.V

1 Tribufos 6 Label with EPA comments

Initial EPA Registration

EPA Reg. No. 85678-15 EPA Est. No._

Net Contents:

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85678.15.20110512.V1 Tribufo s 6 Label with EPA comments

Initial EPA Registration

PRECAUTIONARY STATEMENT S

HAZARDS TO HUMANS AND DOMESTIC ANIMALS

DANGER: Corrosive. Causes skin burns and irreversible eye damage. May be fatal if absorbed through skin or

swallowed. Harmful if inhaled. D o not get in eyes, on skin or on clothing. Avoid breathing vapor or spray mist.

Personal Protective Equipment (PPE):

Some materials that are chemical resistant to this product are made out of barrier laminate, buty l rubber, nitril e

rubber, or viton. If you want more options, follow the instructions for category F on an EPA chemical-resistance

category selection chart.

Applicators and other handlers must wear:

Coveralls over long-sleeved shirt and long pants,

- Chemical-resistan t gloves ,

- Chemical-resistan t footwea r plus socks,

Protective eyewear,

- Chemical-resistan t headgear for overhead exposure, and

Chemical-resistant apro n when cleaning equipment, mixing , or loading.

Discard clothing and other absorbent materials that have been drenched or heavily contaminated with this

product's concentrate. Do not reuse them. Follow manufacturer's instructions for cleaning/maintaining PPE . If

no such instructions for washables, use detergent and hot water. Keep and wash PPE separately from other

laundry.

ENGINEERING CONTROLS STATEMENTS:

Mixers and loaders supporting aerial applications mus t use a mechanical transfer system that meets the

requirements listed in the Worker Protection Standard (WPS) for agricultural pesticides [40 CFR 170.240(d)(4) ]

for providing dermal protection. The system must be capable of removing the pesticide from the shippin g

container and transferring it into mixing tanks and/or application equipment. At any disconnect point, the

system must be equipped with a dry disconnect or dry couple shut-off device that is warranted b y the

manufacturer to minimize drippage to not more than 2 ml. per disconnect point. In addition to wearing the

specified PPE, all handlers of this product must wear chemical resistant gloves and a chemical resistant apron.

Persons using a closed system that operates under pressure shall wear protective eyewear.

Pilots must use an enclosed cockpit that meets the requirements liste d in the Worker Protection Standard

(WPS) for agricultural pesticides [4 0 CFR 170.240(d)(6)] .

User Safety Recommendations

User should:

Wash hands before eating, drinking, chewing gum, using tobacco or using the toilet.

- Remov e clothing/PPE immediately if pesticide gets inside. Then wash thoroughly and put on clean

clothing.

Users should remove PPE immediately after handling this product. Wash the outside of gloves before

removing. As soon as possible, wash thoroughly and change into clean clothing.

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85678.15.20110512.V1 Tribufo s 6 Label with EPA comments

Initial EPA Registration

ENVIRONMENTAL HAZARD S

This product is toxic to terrestrial and aquatic plants, fish and aquatic invertebrates. Do not apply directly to

water, or to areas where surface water is present or to intertidal areas below the mean high water mark. Do not

apply where runoff is likely to occur. Do not apply when weather conditions favor drift from areas treated. Do

not contaminate water when disposing of equipment washwaters or rinsate. Apply this product only as

specified on this label.

Physical or Chemical Hazards

Combustible: D o not use or store near heat or open flame.

DIRECTIONS FOR USE

It is a violation of Federal law to use this product in a manner inconsistent with its labeling.

Application Restrictions

Do not apply this product in a way that will contact workers or other persons, either directly or through drift.

Only protected handlers may be in the area during application. Fo r any requirements specifi c to your State or

Tribe, consult the agency responsible for pesticide regulation. Cotton treated with this product must be

mechanically harvested. Han d harvesting is prohibited. Do not allow this product to drift.

AERIAL SPRAY DRIFT MANAGEMEN T

Avoiding spray drift at the application site is the responsibility of the applicator. The interaction of many

equipment- and-weather-relate d factors determine the potential for spray drift. The applicator and the grower

are responsible for considering al l these factors when making decisions .

The following drift management requirements mus t be followed to avoid off-target drift movement from aerial

applications to agricultural field crops. These requirements do not apply to forestry applications, public health

uses or to applications using dry formulations.

1. Th e distance of the outer most nozzles on the boom must not exceed 3/4 the length of the wingspan or

rotor.

2. Nozzle s must always point backward parallel with the air stream and never be pointed downwards

more than 45 degrees.

Where states have more stringent regulations , they should be observed.

The applicator should be familiar with and take into account the information covered in the Aerial Drift

Reduction Advisory Information.

Aerial Drift Reduction Advisory: This section is advisory in nature and does not supersede the mandatory

label requirements .

Information on Droplet Size: The most effective way to reduce drift potential is to apply large droplets. The best

drift management strateg y is to apply the largest droplets that provide sufficient coverage and control. Applying

larger droplets reduces drift potential, but will not prevent drift if applications are made improperly, or under

unfavorable environmental conditions (see Wind, Temperature and Humidity, and Temperature Inversions).

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Controlling Droplet Size

- Volum e - Use high flow rate nozzles to apply the highest practical spray volume. Nozzles with higher rated

flows produce larger droplets .

- Pressur e - Do not exceed the nozzle manufacturer's specified pressures. For many nozzle types lower

pressure produces larger droplets. When higher flow rates are needed, use higher flow rate nozzles

instead of increasing pressure .

- Numbe r of nozzles - Use the minimum number of nozzles that provide uniform coverage.

- Nozzl e Orientation - Orienting nozzle s so that the spray is released parallel to the airstream produces

larger droplets than other orientations and is the recommended practice . Significant deflection from

horizontal will reduce droplet size and increase drift potential.

- Nozzl e Type - Use a nozzle type that is designed for the intended application . With most nozzle types,

narrower spray angles produce larger droplets. Consider using low-drift nozzles. Solid stream nozzles

oriented straight back produce the largest droplets and the lowest drift.

Boom Length: Fo r some use patterns, reducing the effective boom length to less than 3/4 of the wingspan or

rotor length may further reduce drift without reducing swath width.

Application Height: Applications should not be made at a height greater than 10 feet above the top of the

largest plants unless a greater height is required for aircraft safety. Making applications at the lowest height

that is safe reduces exposure of droplets to evaporation and wind.

Swath Adjustment: When applications are made with a crosswind, the swath will be displaced downwind .

Therefore, on the up and downwind edges of the field, the applicator must compensate for this displacemen t

by adjusting the path of the aircraft upwind. Swath adjustment distance should increase, with increasing drift

potential (higher wind, smaller drops, etc.)

Wind: Drif t potential is lowest between wind speeds of 2-10 mph. However, many factors, including droplet size

and equipment type determine drif t potential at any given speed. Application should be avoided below 2 mph

due to variable wind direction and high inversion potential .

NOTE: Loca l terrain can influence wind patterns. Every applicator should be familiar with local wind pattern s

and how they affect spray drift.

Temperature an d Humidity : Whe n makin g application s i n low relativ e humidity , se t u p equipment t o produc e

larger droplet s t o compensate fo r evaporation. Drople t evaporatio n is most severe when conditions ar e both

hot and dry.

Temperature Inversions: Applications should not occur during a temperature inversion because drift potential is

high. Temperature inversion s restrict vertical air mixing, which causes small suspended droplets to remain in a

concentrated cloud. This cloud can move in unpredictable directions due to the light variable winds common

during inversions. Temperature inversion s are characterized by increasing temperatures with altitude and are

common on nights with limited cloud cover and light to no wind. They begin to form as the sun sets and often

continue into the morning. Their presence can be indicated by ground fog; however, if fog is not present,

inversions can also be identified b y the movement of smoke from a ground source or an aircraft smoke

generator. Smoke that layers and moves laterally in a concentrated cloud (under low wind conditions) indicate s

an inversion, while smoke that moves upward and rapidly dissipates indicates good vertical air mixing.

Sensitive Areas: The pesticid e shoul d only b e applied when the potentia l for drift to adjacent sensitiv e areas

(e.g. residential areas, bodies of water, known habitat for threatened or endangered species , non-target crops)

is minimal (e.g. when wind is blowing away from the sensitive areas).

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85678.15.20110512:V1 Tribufo s 6 Label with EPA comments

Initial EPA Registration

AGRICULTURAL USE REQUIREMENTS

Use this product only in accordance with its labeling an d with the Worker Protection Standard, 40 CFR part

170. This Standard contains requirements fo r the protection of agricultural workers on farms, forests,

nurseries, and greenhouses, and handlers of agricultural pesticides. I t contains requirements for training,

decontamination, notification , and emergency assistance. It also contains specific instruction s and exceptions

pertaining to the statements on this label about personal protective equipment (PPE ) and restricted entr y

interval. The requirements i n this box only apply to uses of this product that are covered by the Worker

Protection Standard .

Do not enter or allow worker entry into treated areas during the restricted entry interval (REI) of 7 days.

PPE required for early entry to treated areas that is permitted under the Worker Protection Standard and that

involves contact with anything that has been treated, such as plants, soil,.or water, is:

Coveralls over long-sleeved shirt and long pants

- Chemical-resistan t gloves , such as barrier laminate or butyl rubber or nitrile rubber or viton

Chemical-resistant footwear plus socks

- Protectiv e eyewea r

Chemical-resistant headgea r for overhead exposure

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85678.15.20110512.V1 Tribute s 6 Label with EPA comments

Initial EPA Registration

STORAGE AND DISPOSAL

Do not contaminate water, food or feed by storage or disposal.

Pesticide Storage: Store in a cool, dry place, away from open flame and extreme heat, and in such a

manner as to prevent cross contamination with other pesticides, fertilizers , food, and feed. Store in original

container and out of the reach of children, preferably i n a locked storage area.

Handle and open container in a manner as to prevent spillage. I f container is leaking invert to preven t

leakage. If the container is leaking or material is spilled for any reason or cause, carefully dam up spilled

material to prevent runoff. Refer to Precautionary Statements on label for hazards associated with the

handling of this material. Do not walk through spilled material. Absorb spilled material with absorbing type

materials and dispose of as directed below . In spill or leak incidents, kee p unauthorized people away.

Pesticide Disposal: Pesticide wastes are acutely hazardous. Improper disposal of excess pesticide, spra y

mixture, or rinsate is a violation of Federal Law. If these wastes cannot be disposed of by use according to

label instructions, contact your State Pesticide or Environmental Contro l Agency or the Hazardous Waste

representative a t the nearest EPA Regional Office for guidance.

Container Disposal:

NONREFILLABLE CONTAINER (EQUA L TO OR LESS THAN 5 GALLONS): Do not reuse or refill this

container. Triple rinse container (or equivalent) promptl y after emptying. Triple rinse as follows: Empty the

remaining contents into application equipment or a mix tank and drain for 10 seconds after the flow begins to

drip. Fill the container % full with water and recap. Shake for 10 seconds. Pour rinsate into application

equipment or a mix tank or store rinsate for later use or disposal. Drain for 1 0 seconds after the flow begins

to drip. Repeat this procedure two more times. Offer for recycling, if available or puncture and dispose of in a

sanitary landfill.

NONREFILLABLE CONTAINER (GREATE R THAN 5 GALLONS): Do not reuse or refill this container.

Triple rinse container (or equivalent) promptl y after emptying. Triple rinse as follows: Empty the remainin g

contents into application equipment or a mix tank. Fill the container % full with water. Replace and tighten

closures. Tip container on its side and roll it back and forth, ensuring at least one complete revolution, for 30

seconds. Stan d the container on its end and tip it back and forth several times. Turn the container ove r onto

its other end and tip it back and forth several times. Empty the rinsate into application equipment o r a mix

tank or store rinsate for later use or disposal. Repea t this procedure two more times. Offer for recycling, if

available or puncture and dispose of in a sanitary landfill.

REFILLABLE CONTAINER: Refill this container with pesticide only. D o not reuse this container for any

other purpose. Cleaning the container before final disposal is the responsibility o f the person disposing of the

container. Cleaning before refilling is the responsibility o f the refiller. To clean the container before final

disposal, empty the remaining contents from this container into application equipment o r mix tank. Fill the

container about 10 percent full with water. Agitate vigorously or recirculate water with the pump for 2 minutes.

Pour or pump rinsate into application equipment o r rinsate collection system. Repeat this rinsing procedur e

two more times. Offer for recycling, if available or puncture and dispose of in a sanitary landfill .

PRODUCT INFORMATIO N

TRIBUFOS 6 is a cotton defoliant which may be used for the removal of leaves from cotton plants prior to the

anticipated harvest of the crop. TRIBUFOS 6 contains six (6) pounds of active ingredient pe r gallon. It is noncorrosive and non-clogging to spray equipment and does not constitute a fire hazard.

TRIBUFOS 6 must be applied in sufficient amounts of spray carrier to provide thorough coverage of leaves.

TRIBUFOS 6 treated leaves do not appear affected until defoliation actually begins and the leaves drop in a

green condition. Under favorable conditions, defoliation of cotton normally occurs within four to seven days

following application. Advers e conditions such as low temperature (especially temperatures below 60°F at

night), low humidity or plant stress may extend the defoliation time to nine to fourteen days. Under these

adverse conditions, use the higher specified TRIBUFOS 6 rate and/or use diesel oil rather than water as the

spray carrier.

7 '

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Initial EPA Registration

Heavy rainfall during or immediately following a TRIBUFOS 6 application may result in reduced performance.

Application is not recommended when a heavy rainfall is expected within one hour after treatment. De w on the

plant leaves at time of application should not affect performance.

TRIBUFOS 6 does not suppress second growth (regrowth), especially where rainfall follows defoliation. A

second application of TRIBUFOS 6 or a tank mixture of TRIBUFOS 6 with specified labele d cotton harvest aid

products will be effective for defoliation of the second growth if excessive second growth has occurred.

TRIBUFOS 6 may be used alone for bottom defoliation or for general plant defoliation. TRIBUFOS 6 may also

be applied in tank mixture with specified registere d products for enhanced cotton harvest aid activity.

USE RESTRICTIONS

Do not apply more than 1 1/2 pints (1.125 Ibs ai/A) of TRIBUFOS 6 per acre per crop season in all States

except California and Arizona. Do not apply more than 2 1/2 pints (1.875 Ibs ai/A) per acre per crop season in

California and Arizona only.

TRIBUFOS 6 is suitable for use in all power-operated ground and aircraft sprayers. Do not apply TRIBUFOS 6

through any type of irrigation equipment .

Do no t us e TRIBUFOS 6 o n an y othe r cro p except cotton . Avoi d spra y drif t t o susceptibl e plants , a s thi s

product may injure or defoliate other crops.

Do not graze treated fields.

Do not apply TRIBUFOS 6 within seven (7) days of harvest.

Observe all labeling cautions and limitations of all products used in tank mixtures .

MIXING INSTRUCTIONS

Compatibility of TRIBUFOS 6 or its labeled tank mix products should always be predetermined prio r to mixing .

Refer to the COMPATIBILITY SECTION of this label for further details .

TRIBUFOS 6 Alone: Fill the spray tank 1/2 to 3/4 full of clean water. Initiate the recirculation and agitation

system and add the specified amount of TRIBUFOS 6. Continue sufficient agitation from the time of mixing

through application to ensure a uniform spray mixture. Follow the same mixing instructions when diesel oil is

substituted for water.'

TRIBUFOS 6 Tank Mixtures: Fill the spray tank 1/2 to 3/4 full of clean water and begin the sprayer recirculatio n

and agitation system. If tank mixing with wettable powders of other dry products, make a slurry of these

products with water and add slurry slowly to the spray tank. Next add the specified amount of TRIBUFOS 6. If

mixing spray adjuvants in the mixture, add them after all other products have been mixed. Fill the spray tank to

the desired level with water and continue agitation during transport and application until the spray tank is

empty. Follow the same mixing instructions when diesel oil is substituted for water.

Addition of Adjuvants: To improve spray coverage, TRIBUFOS 6 may be applied with the following types of

adjuvants: 1) commercial blends of vegetable or petroleum-based oils , 2) non-ionic surfactant and 3) diesel oil

(if allowed by local regulations). Adding or using diesel oil (3 to 5 gallons by air or a minimum of 5 gallons by

ground) may be helpful when night temperatures drop below 60°F, plants are under moisture stress, or on

storm-proof cotton varieties. Use only those adjuvants which are exempt from tolerance requirements unde r 40

CFR 180.1001 .

i

Compatibility: To determine the compatibility of TRIBUFOS 6 with other products, do the following: 1 ) pour the

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85678.15.20110512.V1 Tribufo s 6 Label with EPA comments

Initial EPA Registration

specified proportions of the products into a suitable container of water, 2) mix thoroughly and 3) allow to stand

at least five minutes. If the combination remains mixed or can be re-mixed readily, it is considered physically

compatible.

SPRAY EQUIPMENT CLEANING AND DECONTAMINATION

Immediately after applying TRIBUFOS 6 alone or in tank mixtures, remove all unused spray mixture and follow

directions on this label for disposal. Do not allow the pesticide mixture s to dry in the spray equipment. Drie d

pesticide residues may become resuspended and damage other crops if uncleaned spray equipment i s used

to apply other products during the same or the following year.

Thoroughly clean the spray tank, lines, nozzles and exterior surfaces of equipment immediatel y before and

after applying TRIBUFOS 6 alone or tank mixtures and before using the spray equipment the following year.

Use a cleaner such as "Spic and Span," "Fantastic," or "Formula 409." Remove dried deposits from the

exterior surfaces, especially aircraf t fabric. This cleaning is particularly important if the spray equipment ha s

been used to apply Dropp 50WP or products containing chlorates . Follow directions on this label for disposal of

wash and rinse water.

APPLICATION PROCEDURE S

TRIBUFOS 6 alone ma y be applied wit h al l suitable powe r operated groun d and aircraft sprayer. If applying

TRIBUFOS 6 in tank mixture, refer to the application procedures of the tank mix partner and following the most

restrictive label. Do not apply TRIBUFOS 6 through any type of irrigation system.

Ground Application: Us e spray equipment that provides a uniform and accurate application. A minimum spray

volume of 10 gallons per acre is specified when TRIBUFOS 6 is applied with water and a minimum of 5 gallons

per acre is specified when TRIBUFOS 6 is applied in diesel oil.

Aerial Application: Use aerial equipment calibrated to provide accurate and uniform spray coverage and

application rates and to minimize the potential for spray drift. Do not apply when wind may cause drift.

A minimum spray volume of 5 gallons per acre should be used when TRIBUFOS 6 and tank mixtures with

TRIBUFOS 6 are applied with water. TRIBUFOS 6 alone may be applied in a minimum of 3 gallons of spray

volume per acre when using diesel oil (minimum of 5 gallons per acre in California).

Aerial applicators must be in enclosed cockpits.

USE RATES

Use the specified use rate of TRIBUFOS 6 in water or once refined vegetable oil or diesel oil. Apply sufficient

spray to ensure uniform leaf wetting. All leaves must be treated for complete defoliation. TRIBUFOS 6 does

not suppress secondary growth.

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85678.15.20110512.V1 Tributes 6 Label with EPA comments

Initial EPA Registration

APPLICATION RATES

CROP

Cotton

CA&AZ

All Other States

All States

Rank Cotton

CA&AZ

All Other States

Long Staple Cotton

(including Pima)

CA&AZ

All Other States

TRIBUFOS 6 RATE

Pints/acre

1 1/3 to 2

1 1/3 to 1 1/2

MINIMUM WATER SPRAY VOLUME*

Gallons per Acre

AIR

5

GROUND

15

GENERAL PLANT DEFOLIATION a

Apply specified dosage per acre to give thorough coverage of leaves when at

least 50% of bolls are open, or according to local recommendations for Node

Above Cracked Boll (NACB). For LV/ULV application, use not less than 1 1/2

pints per acre of once refined vegetable oil. For rank cotton, see below.

1 to 1 1/2 I 10

BOTTOM DEFOLIATION ^

Apply specified dosage (the rate should be proportional to the fraction of the

plant being defoliated) per acre with spray directed only to the lower part of the

plant where mature bolls are found.

21/2

1 1/2

5 15

RANK COTTON DEFOLIATION

Apply specified dosage per acre to give thorough coverage of leaves when at

least 50% of bolls are open, or according to the local recommendation for Node

Above Cracked Boll (NACB). The total rate may be applied in one or two

applications (2 to 6 weeks apart) either alone or in an approved tank mix. To

achieve more complete general plant defoliation, especially when using the 1 1/2

pints, use with an approved tank mixture is highly recommended. For LV/ULV

applications, a maximum of 2 1/2 (CA,AZ) or 1 1/2 (all other states) pint s per acre

of TRIBUFOS 6 per use season may be applied in not less than 1 1/2 pints per

acre of once refined vegetable oil.

2 to 2 1/2

1 1/2

5 15

LONG STAPLE (INCLUDING PIMA) COTTON DEFOLIATION

Apply specified dosage to mature cotton plants with 50% or more open bolls. For

best results on pima cotton, use in tank mix combination with 0.2 to 0.4 Ib Dropp

50 WP per acre when 60% or more bolls are open.

a

 General Plan t Defoliation: Appl y to mature cotton plants when 50% or more of the bolls are open and 7 to

10 days prior to anticipated picking. Plant s are considered mature if the youngest bolls 1) cannot be dented

by pressure between the thumb and forefinger or 2) cannot be cut through easily with a sharp knife. b

 Bottom Defoliation: Losses from rot and weathering may be reduced by using TRIBUFOS 6 to increase air

movement and sunlight to bottom bolls. Use shielded drop nozzles to direct sprays to the lower leaves. By

removing the picker's top 8 to 12 rows of spindles, the exposed bolls may be harvested. The picker will not

injure the untreated top leaves and immature bolls. TRIBUFOS 6 may be applied for entire plant defoliation

when top bolls are mature.

* If using diesel oil as the spray carrier, refer to the APPLICATION PROCEDURES sectio n for minimum

spray volume information.

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TANK MIX PARTNER S

TRIBUFOS 6 may be applied in tank mixture with additional registered cotton harvest aid products to enhance

cotton desiccation, defoliation and/or regrowth control. They may be applied with similar timings and methods

as TRIBUFOS 6 alone unless specifically prohibited in the mix partner product label. In some cases, cotton

harvest aid performance may be affected by the temperature sensitivity of the tank-mix partner. Refer to the

individual produc t labels for additional informatio n on use rates, precautions and/or restrictions. The following

products are recommended for tank mixtures with TRIBUFOS 6:

Accelerate

Boll'd 6

CottonQuik

Cyclone Star

Ethephon 6

Ginstar

Roundup

Roundup Ultra

Harvest Pro

TANK MIX PARTNERS REMARKS

Thidiazuron Use 1 to 1 1/2 pints of TRIBUFOS 6 plus 0.066 to 0.1 Ib of thidiazuron

for defoliation and inhibition of secondary growth (regrowth). Tank mix

activity is maximum when 60% or more bolls are open and the mean

24-hour temperature befor e and after application is above 60° F.

Adverse conditions may require 1) use of the maximum dosage, 2) a

second application or 3) longer time for complete defoliation .

Mix TRIBUFOS 6 and Thidiazuron combinations in the following order:

1) water, 2) Thidiazuron (as per label), 3) after Thidiazuron ha s

completely dispersed add TRIBUFOS 6 and 4) adjuvant (if used). Do

not apply this combination to immature cotton (< 60% open boll) or at

higher than specified use rates as desiccation and leaf freezing may

occur.

When used in citrus growing areas, observe buffer zones restrictions.

Refer to the Thidiazuron label for additional precautions , restrictions or

comments.

Accelerate

Boll'd 6

CottonQuik

Ethephon 6

Harvest Pro

Tank mix with TRIBUFOS 6 at 1 to 1 1/2 pints per acre for enhanced

speed of defoliation and cotton boll opening. Refer to the tank mix

partners label for the use rates, precautions, restrictions and additional

comments.

Cyclone Star

Ginstar

Tank mix with TRIBUFOS 6 at 1 to 1 1/2 pints per acre for enhanced

desiccation of cotton and certain weed species. Refer to the tank mix

partners label for use rates, precautions, restrictions and additional

comments.

Roundup

Roundup Ultra

In states where permitted, tank mix with TRIBUFOS 6 at 1 to 1 1/2

pints per acre for enhanced defoliation, regrowth control and additional

late season weed control. Refer to the tank mix partners label for use

rates, precautions, restrictions and additional comments.

11

13
85678.15.20110512.V1 Tribufo s 6 Label with EPA comments

Initial EPA Registration

WARRANTY AND DISCLAIMER STATEMENT

Read th e entir e Direction s fo r Use , Conditions , Disclaime r o f Warrantie s an d Limitation s o f Liabilit y befor e

using this product. I f terms are not acceptable, retur n the unopened product container at once.

By using this product, user or buyer accepts the following Conditions , Disclaime r o f Warranties and Limitation s

of Liability.

Treatment o f highl y mechanicall y damage d seed , o r seed o f know n lo w vigor an d poo r qualit y ma y resul t i n

reduced germinatio n and/o r reductio n o f seed an d seedling vigor.. Trea t an d conduc t germinatio n tests o n a

small portio n o f see d befor e committin g th e tota l see d lo t t o a selecte d chemica l treatment . Du e to see d

quality condition s beyon d th e contro l o f RedEagl e Internationa l LLC , n o claim s ar e mad e t o guarante e

germination of carry-over seed.

CONDITIONS: Th e direction s fo r us e o f thi s produc t ar e believe d t o b e adequat e an d mus t b e followe d

carefully. However , i t is impossible t o eliminate al l risk s associated with the us e of this product . Cro p injury ,

ineffectiveness o r other unintende d consequence s ma y result becaus e of such factors as weather conditions ,

presence o f othe r materials , o r th e manne r o f us e o r application , al l o f whic h ar e beyon d th e contro l o f

RedEagle International LLC . T o the extent allowabl e unde r Stat e law, all such risk s shal l be assumed b y the

user or buyer.

DISCLAIMER O F WARRANTIES: T O THE EXTEN T CONSISTEN T WIT H APPLICABLE LAW , REDEAGLE

INTERNATIONAL LL C MAKES NO WARRANTIES, EXPRESS OR IMPLIED, OF MERCHANTABILITY OR OF

FITNESS FOR A PARTICULAR PURPOSE OR OTHERWISE, THAT EXTEND BEYOND THE STATEMENT S

MADE O N THI S LABEL . N o agen t o f RedEagl e Internationa l LL C i s authorize d t o mak e an y warrantie s

beyond those contained herein or to modify the warranties contained herein. T O THE EXTENT CONSISTEN T

WITH APPLICABL E LAW , REDEAGL E INTERNATIONA L LL C DISCLAIMS ANY LIABILIT Y WHATSOEVE R

FOR SPECIAL , INCIDENTA L O R CONSEQUENTIA L DAMAGE S RESULTIN G FRO M TH E US E O R

HANDLING OF THIS PRODUCT.

LIMITATIONS O F LIABILITY: T O THE EXTENT CONSISTENT WITH APPLICABLE LAW , THE EXCLUSIV E

REMEDY OF THE USER OR BUYER FOR ANY AND ALL LOSSES , INJURIES O R DAMAGES RESULTING

FROM TH E US E O R HANDLIN G O F THI S PRODUCT , WHETHE R I N CONTRACT , WARRANTY , TORT ,

NEGLIGENCE, STRIC T LIABILITY O R OTHERWISE, SHAL L NOT EXCEED THE PURCHASE PRIC E PAID,

OR AT REDEAGLE INTERNATIONAL LLC'S ELECTION, THE REPLACEMENT OF PRODUCT.

Ginstar is a registered trademarks of Bayer.

RoundupO/Roundup Ultra® are trademarks of Monsanto Company.

Cyclone Star® is a trademark of Syngenta Crop Protection.

Accelerate® is a trademark of United Phosphorus

CottonQuik® is a trademark of NuFarm America.

Ethephon 6 is a trademark of RedEagle International LLC .

HarvestPro i s a trademark of IAP.

Boll'd 6® is a trademark of Winfield Solutions.

Manufactured for :

RedEagle International LLC

1925 E Edgewood Drive, Suite 105

Lakeland, FL 33803

12

14
REGISTRATION NOTE FOR RECORD

EPA Reg. No./ File Symbol:

Product Name:

Application Date:

Action Description:

85678-RL(15)

Tribufos 6

2/21/2011

R300

PRODUCT CHEMISTRY: (DP387996 ; 3/29/11)

Basic CSF dated 3/17/11

Submitted own product chemistry studies (MRID 48396301-04)

Substantially similar to Reg# 5481-9023

Data Gaps: Storage Stability and Corrosion Characteristics

ACUTE TOXICITY: (DP387997 : 4/19/11)

Substantially similar to Reg# 5481-9023

Cite-all acute tox 6 pack studies; review based on cited product's profile

Tox Category I for Primary Eye & Skin Irritation

Tox Category II for Acute Oral & Dermal Toxicity

Tox Category III for Acute Inhalation Toxicity

Negative for Skin Sensitization

GENERIC DATA :

Cite-all to support tribufos generic data

LABEL REVIEW :

Label comments sent via email on 5/12/11

Revised label received 5/12/11

COMMENTS:

Cotton defoliant; organophosphate.

DECISION:

Unconditional Registratio n with Data Requirements

Reviewer: Mindy Ondish Date:

15
RE: 85678-RL Tribufos 6 - REVISED

Catherine Byrd to : Mind y Ondish 05/12/201 1 03:52 PM

1 attachment

•g

j«s

85678-15.20110512.V1.pdf

Good afternoon Mindy,

I have attached the revised label incorporating your comments. Please feel

free to contact me with any questions.

Thank you,

Catherine

Catherine M. Byrd

Regulatory Associat e

Please note that our address and phone numbers have changed.

P.O. Box 640

7217 Lancaster Pike, Suite A

Hockessin, Delaware 19707

P: 302.635.7283

C: 302.766.341 4

F: 302.635.7295

www.wagnerreg.com

Original Message

From: Ondish.Mindy@epamail.epa.gov [mailto:Ondish.Mindy@epamail.epa.gov ]

Sent: Thursday, May 12, 2011 3:35 PM

To: Catherine Byrd

Subject: 85678-RL Tribufos 6 - REVISED

Revised comment #3

Catherine,

The proposed labe l for 85678-RL requires the following changes :

1. Chang e "INER T INGREDIENTS" to "OTHER INGREDIENTS".

2. Unde r FIRST AID heading, add the statement "CONTAIN S AN

ORGANOPHOSPHATE THAT INHIBITS CHOLINESTERASE" .

3. Unde r Note To Physician, add "Contains petroleum distillates.

Vomiting may cause aspiration pneumonia. Probabl e mucosal damage may

contraindicate the use of gastric lavage."

4. Chang e the EPA Reg. No. to "85678-15".

5. Chang e the HAZARDS TO HUMANS AND DOMESTIC ANIMALS statemen t to read

"DANGER: Corrosive . Cause s skin burns and irreversible eye damage.

May be fatal if absorbed through skin or swallowed. Harmfu l if inhaled.

Do not get in eyes, on skin, or on clothing. Avoi d breathing spra y

16
mist. "

6. Unde r PPE, change "Applicators must wear:" to "Applicators and other

handlers must wear:". 7. Unde r Pesticide Disposal, change "Pesticide wastes are toxic." to

"Pesticide wastes are acutely hazardous." 8. Unde r Container Disposal for Refillable Container, add "Offer for

recycling, if available or puncture and dispose of in a sanitary

landfill." at the end of the paragraph. 9. Throughou t the label, remove "recommended" or revise to "specified"

when describing application of this product. 10. O n page 9 under BOTTOM DEFOLIATION, correc t the box to "Apply

specified dosage...only t o the lower part of the plant where mature

bolls are found."

Please revise the label and resubmit for review. Also , please note the

PRIA due date is 6/16/11.

Thanks,

Mindy Ondish

Biologist / Risk Reviewer

Herbicide Branch (P M Team 25)

Registration Division (7505P )

Office of Pesticide Programs

U.S. Environmental Protection Agency

(703)605-0723

17
EPA Fil e Symbo l 85678-R L

PC Code 074801 (tribuphos)

UNITED STATES ENVIRONMENTAL PROTECTION AGENC Y

WASHINGTON, D.C. 2046 0

OFFICE O F CHEMICAL SAFET Y AN D

POLLUTION PREVENTIO N

TECHNICAL REVIEW BRANCH

SIMILARITY DETERMINATION

19/APR/2011

MEMORANDUM

Subject: Nam e of Pesticide Product: Tribufo s 6

EPA Reg. No. /File Symbol: 85678-R L

DP Barcode: D38799 7

Decision No : 44567 0

Action Code: R30 0

PC Code: 07480 1 (tribuphos)

From: Eugeni a McAndrew, Biologist

Technical Revie w Branc h

Registration Division (7505P)

To: Mind y Ondish, RM Team 25

Herbicide Branc h

Registration Division (7505P)

Applicant: RedEagl e International LLC

c/o Wagner Regulatory Associates, Inc .

P.O. Box 640

Hockessin, DE 1970 7

FORMULATION FROM LABEL:

Active Ingredient(s):

Tribuphos

Other InRredient(s):

Total:

% by wt.

70.5

29.5

100.0%

ACTION REQUESTED: Th e Risk Manager requests: Me-to o registratio n for 70.5% tribufos

EP, claiming substantial similarity to 5481-9023 .

Page 1 of 4

18
EPA File Symbol 85678-RL

PC Code 074801 (tribuphos)

BACKGROUND: RedEagl e International LLC has applied for registration of Tribufo s 6,

EPA File Symbol 85678-RL, claimin g similarity to DBF 6 Emulsifiable Defoliant, EPA Reg.

No. 5481-9023. The active ingredient in both products is 70.5% tribuphos. The Registrant is

using the cite-all method of data support to satisfy th e acute toxicity data requirements. A basic

CSF dated March 17, 2011, a proposed label, and company letter are included in the submission.

A search of the OPP electronic databases shows that acute toxicity studies were submitted to

support the registration of the cited product, 5481-902 3 (transferred from 264-73 0 which was

transferred from 3125-282). These studies were reviewed and classified as acceptable in three

Registration Support Branch memos (Perry; EPA Reg. No. 3215-282; 12/MAY/1992,

Markarian; EPA Reg. No. 3125-282; 20/MAY/1993 and Ritter; D224412; EPA Reg. No. 3125-

282; 06/JUN/1996).

RECOMMENDATIONS:

1. TR B compare d th e basi c formulation s o f th e propose d product , 85678-RL , an d th e cite d

product, 5481-9023, and determined that the two products are substantially similar.

2. The acute toxicity profile for the proposed product, Tribufos 6, EPA File Symbol 85678-RL,

is as follows:

acute oral toxicity I I cited .EP A Reg. No. 5481-902 3

acute dermal toxicity I I cite d EP A Reg. No. 5481-9023

acute inhalation toxicity II I cite d EP A Reg. No. 5481-9023

primary eye irritation I cite d EP A Reg. No. 5481-902 3

primary skin irritation I cite d EP A Reg. No. 5481-902 3

dermal sensitization negativ e cite d EP A Reg. No. 5481-9023

3. This memorandu m pertain s onl y t o th e decisio n concernin g whethe r th e subjec t produc t is

similar t o th e cite d produc t fro m a n acut e toxicologica l vie w point . Fo r th e purpose s o f this

action, TRB has made no further determinatio n of the adequacy of the toxicological data base or

the precautionary label of the cited product.

4. Th e propose d basi c CS F submitte d fo r 85678-R L mus t b e accepte d b y th e TR B Produc t

Chemistry Team.

Page 2 of 4

19
EPA Fil e Symbol 85678-RL

PG Code 074801 (tribuphos)

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:

PRODUCT ID #: 085678-0001 5

PRODUCT NAME: Tribufo s 6

PRECAUTIONARY STATEMENT S

SIGNAL WORD: DANGE R

SPANISH SIGNAL WORD: PELIGR O

Si usted no entiende l a etiqueta, busque a alguien para que se la explique a usted en detalle .

(If yo u do not understand the label, find someone to explain it to you in detail.)

Hazards to Humans and Domestic Animals :

Contains Petroleum Distillate .

Restricted Use Pesticide due to toxicity categories. Fo r retail sale to and use only by Certified Applicators

or persons under their direct supervision and only for those uses covered by the Certified Applicator's

certification.

Corrosive. Causes skin burns. Causes irreversible ey e damage. May be fatal i f absorbed through skin . May

be fatal if swallowed. Harmful if inhaled. D o not get i n eyes, on skin, or on clothing. Avoi d breathin g

spray mist .

Personal Protective Equipment fo r Applicators :

Wear coveralls worn over long-sleeved shirt and long pants , socks, chemical-resistant footwear, an d

chemical-resistant gloves (such as Barrier Laminate, Buty l Rubber, Nitrile Rubber , Viton, Barrie r Laminate ,

Viton, Selection Category F, G). I f th e Selection Category F, G gloves do not provide adequate protectio n

for this product , th e registrant shoul d indicate a specific glove category from the EPA chemical resistance

glove selection chart that will provide adequate protection. Wear protective eyewea r (goggles, fac e

shield, or safety glasses).

Follow the manufacturer's instructions fo r cleaning/maintaining PPE . If n o such instructions fo r

washables, use detergent and hot water. Keep and wash PPE separately from other laundry. When

mixing and loading wear a chemical resistant apron. For overhead exposure wear chemical-resistant

headgear. When cleaning equipment wea r a chemical-resistant apron.

User Safety Recommendations :

Wash thoroughly wit h soap and water after handlin g and before eating, drinking, chewing gum, o r using

tobacco. Remove and wash contaminated clothin g befor e reuse.

Page 3 of 4

20
EPA Fil e Symbol 85678-RL

PC Code 074801 (tribuphos)

First Aid:

If on skin:

-Take off contaminated clothing.

-Rinse skin immediately with plent y of water for 15-20 minutes.

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

If in eyes:

-Hold eye open and rinse slowly and gently with water for 15-20 minutes.

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

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

If swallowed:

-Call a poison control center or doctor immediatel y for treatment advice.

-Do not induce vomiting unles s told to by a poison control center or doctor.

-Do not give any liquid to the person.

-Do not give anything b y mouth to an unconscious person.

If inhaled :

-Move the person to fresh air.

-If perso n is not breathing, cal l 911 or an ambulance, then give artificial respiration , preferabl y mouth-to -

mouth if possible.

-Call a poison control center or doctor for further treatmen t advice .

NOTE TO PHYSICIAN: May pose an aspiration pneumonia hazard. Contains petroleum distillate .

The proposed label should contain a Note to Physician which addresses the category I Primary Skin

Irritant toxicity, Primary Eye Irritant toxicity. The following statements are suggested types of informatio n

that may be included, i f applicable:

- technical information o n symptomatology ;

- use of supportive treatments t o maintain life functions ;

- medicine that will counteract the specific physiological effects of the pesticide ;

- company telephone number to specific medical personnel who can provide specialized medical advice.

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

treatment. Yo u may also contact 1-800-xxx-xxx x for emergency medical treatment information .

Page 4 of 4

21
DP BAR CODE NO. : 38799 6 FIL E SYMBOL NO.: 85678-R L DECISIO N NO.: 44567 0

PC Code(s): 074801 ACTIO N CODE: R30 0

FOOD Use: Ye s NON-FOO D Use : Ye s

DATE OUT: Marc h 29, 2011

SUBJECT: En d Use Product Chemistry Review

Product Name : Tribufo s 6

FROM: Har i Mukhoty

Product Chemistry Tea m

Technical Review Branch / Registration Division (7505P)

TO: Mind y Ondish / Kable Davis PM-2 5

Herbicide Branch / Registration Division (7505P)

Company Name: RedEagl e International LLC

Formulation Type: Liqui d

INTRODUCTION:

The Registrant has submitted one basic CSF (dated: 03/17/2011) and has proposed a product specific labe l

for registration of the aforesaid produc t under EPA File Symbol No. 85678-RL. Th e registrant submitte d

product chemistry dat a under MRIDs: 483963-01, -02, -03 and -04 to support the registration o f the proposed

product.

TRB has been requested to evaluate the product chemistry data required for the registration of the proposed

basic product.

SUMMARY OF FINDINGS:

1. Nam e of Active Ingredient(s): Tribupho s (70.5%).

2. Ha s the registrant claimed substantial similarit y to registered product ?

[X]Ye s [ ] No [jNAIfyes : EP A Reg. No. 5481-902 3 Data reviewed and accepted on 06/20/2006

3. The source material of the active ingredient is registered with the Agency.

4. Al l inert ingredients hav e been screened b y IIAB on 03/17/2011 and have been found to be approved for

food uses (pre-harvest applicatio n to growing crops).

5. The CSF of the proposed basic formulation has been filled out completely and correctly.

22
DP BAR CODE NO.: 38799 6 FIL E SYMBOL NO.: 85678-R L DECISIO N NO.: 44567 0

PC Code(s): 074801 ACTIO N CODE: R30 0

FOOD Use: Ye s NON-FOO D Use: Ye s

4. Confidentia l Statement of Formula(s):

[X] Basic- Dated : 03/17/201 1 re-submitte d - Dated : NA

[X] Alternate # 1 - Dated : N A re-submitted : Dated : NA

Alternate CSF(s) complies with 40CFR §152.43: [ ] Yes [ ] No N A [ X].

5. Produc t label

a. Ingredien t statement : Nomina l concentration o f Al liste d on CSF(s) concur with product label (PR Notice

91-2)

[ X ] Yes

Is the sub statement in compliance with PR Notice 97-6?

[ ] Yes [ X ] No - Uses the term "Inert Ingredients "

, if not, explain below: Shoul d use the term "Other Ingredients"

Metallic equivalent: [ ] Yes [ X ] NA;

Soluble arsenic: [ ] Yes [ X ] NA

Isomeric ratios : [ ] Yes [ X ] NA

Acid equivalent: [ ] Yes [ X ] NA

b. Healt h related sub statements:

Petroleum distillate at > 10%: [X]Ye s [ ] No [ ] NA Labe l Contains - Note to Physicians -

"Contains Petroleum Distillate "

Methanol at > 4%: [ ] Yes [ ] No [ X ] NA

c. Physical chemical hazard statement: Produc t label requires a statement per 40 CFR §156.78 for:

flammability, explosiv e potential or electric insulator breakdown?

[ ]Ye s [X]N o Flas h point is: 182°F .

Total Releas e Fogger PR Notice 98-6 (40 CFR 156.78 d): [ ] Yes [ ] N o [X ] NA

d. Label requires an additional Storage and Disposal statement: [ ] Yes [ X ] No - fro m product chemistry

point of view; if yes explain below:

Final decision of overall label acceptance will be made by the PM.

23
DP BAR CODE NO.: 38799 6

PC Code(s): 074801

FOOD Use: Ye s

6. Grou p A: Produc t Chemistry Data

FILE SYMBOL NO.: 85678-R L DECISIO N NO.: 445670

ACTION CODE: R30 0

NON-FOOD Use: Ye s

TRB's determination of the acceptability o f the data for the proposed product is listed in the table s

below.

Guideline

No.

830.1550

830.1600

830.1650

830.1670

830.1700

830.1750

830.1800

Study Title

Product Identity & Composition

Description of materials use d to

produce the product

Description of

process

Discussion on

impurities

formulation

the formation of

Preliminary analysis

Certified

limits

(158.350)

Standard certified

Limits

Justification for

wider limits

Enforcement analytical method

Data submitted

Yes

X

X

X

X

NA .

X

X

GC/FI

Dand

GC/M

S

No

TRB's

Assessment

of Dat a

A

A

A

A

A

A

MRIDNos.

483963-01, -02, -03

'!

A = Acceptance, NA = Not Acceptable, G = Data Gap,

W = Waiver Request , I = In Progress, N A = Not Applicable

24
DP BAR CODE NO.: 38799 6

PC Code(s): 074801

FOOD Use: Ye s

7. Grou p B:

FILE SYMBOL NO.: 85678-R L

ACTION CODE: R30 0

NON-FOOD Use: Ye s

DECISION NO.: 44567 0

Guideline

No.

830.6303

830.6315

830.6316

830.7000

830.7300

Study Title

Physical State

Flammability

Explodability

PH

Density (units)

Value or Qualitative

Description

Liquid

Flash Point > 1 82° F

No potential to explode

3.1

1.0275g/cm3

TRB's

Assessment

of Dat a

A

A

A

A

A

MRID Nos .

483963-03, -

04

"

»

"

(i

"

A = Acceptance, N = Not Acceptable, G = Data Gap, W = Waiver request ,

NA = Not applicable, I = In progress

CONCLUSIONS:

1. TRB has reviewed the CSF (dated: 03/17/2011) fo r the proposed basic product and has found it to be

acceptable. Th e CSF is attached with this review and can be located in OPPIN CHEM DOCS.

2. Th e proposed product is substantially similar to the cited product.

3. Product chemistry Group A and Group B data, with the exception of one year storage stability (830.6317)

and corrosion characteristics (830.6320), are satisfied and acceptable.

4. The registrant must generate one year storage stability (830.6317) and corrosion characteristic s

(830.6320) data on the proposed product. It is required that the observations be made at 0, 3, 6, 9, and 12

month intervals. Th e results must be submitted to the Agency in electronic and hard copy format.

5. Th e proposed label was screened as it pertains to the product chemistry requirements. Th e final review

of the proposed label and uses are the purview of the PM team.

25
UNITE^TATES ENVIRONMENTAL PROTECTIoW cENCY

WASHINGTON, D.C . 20460

February 25, 2011

OFFICE OF

PREVENTION, PESTICIDES AND

TOXIC SUBSTANCES

REDEAGLE INTERNATIONAL LLC

7460 LANCASTER PIKE , SUITE 9, PO Box 640

HOCKESSIN,DE 19707-064 0

Report of Analysis for Compliance with PR Notice 86-5

Thank you for your submittal o f 23-FEB-l 1. Ou r staff has completed a preliminary

analysis of the material. Th e results are provided as follows:

Your submittal was found t o be in full complianc e with the standards for submission of

data contained in PR Notice 86-5. A copy of your bibliography is enclosed, annotated with

Master Record ID's (MRIDs) assigned to each document submitted. Pleas e use these numbers in

all future references to these documents. Than k you for your cooperation. I f you have any

questions concerning this data submission, please raise them with the cognizant Product

Manager, to whom the data have been released.

26
PRIA 2-21 Da y Content Screen Review Workshee t

(EPA/OPP Us e Only)

3/23/09

21 Day Screen Star t Date: _ 7 . ~ 1- 3 - / I _

Experts In-Processin g Signature : W F

Division management contacted o n issues N o

7<>*J Dat e "Z-T. & -If Fe e Paid: Ye s

Yes _ Dat e _

EPA Reg. Number: C-£ " r - 7 fc - p , EPA Receipt Date: Z-23-/ /

Items for Review

1

2

3

4

5

6

Application Form (EPA Form 8570-l)(lin k t o form) signed & complete

including package typ e

Confidential Statement of Formula all boxes completed , for m signed, and I .»

dated (EPA Form 8570-4 ) (Lin k to form) - Q ^JL, 3 \ \1\ '

a) Al l inerts (link to http://www.epa.gov/opprd001/inerts/), J^' ^

including fragrances, approved for the proposed use s (se e

Footnote A )

yes n o

x .-x ^

Certification wit h Respect to Citation of Data (EPA Form 8570-34 ) (Link to

form) completed an d signed (N/ A if 100% repack )

Certificate and data matrix consistent

If applicant is relying on data that are compensable, i s the offe r

to pay statement included, (see Footnote B)

yes n o

If applicable, is there a letter of Authorization for exclusive use only.

Formulator's Exemption Statement (EPA Form 8570-27 ) (Lin k to form)

completed an d signed (N/A if source is unregistered o r applicant owns the

technical)

Data Matrix (EPA Form 8570-35 ) (Lin k to form) both internal and external

copies (PR 98-5) (Lin k to PR 98-5) completed an d signed (N/A if 100 %

repack)

a) Selectiv e Method (Fe e category experts use)

b) Cite-All (Fee category experts use)

c) Applicant owns all data (Fe e category experts use )

yes n o

^*"" j\

5 Copies of Label (link to http://www.epa.eov/oppfeadl/labeline/lrm/)

(Electronic labels on CD are encouraged and guidanc e is available)* link to

http://www.epa.gov/pesticides/regulating/registering/submissions/index.htmftlabels

Yes

X

X

No N/A*

•

X

X

K

X

1

X

1_

27
7

8

9

10

Is the data package consistent with PR Notice 86-5 (lin k to PRN 86-5)

Notice of Filing (link to

http://www.eDa.eov/pesticides/reeulating/tolerance petitions.htm ) included

with petitions (link to

http://www.epa.gov/pesticides/regulating/tolerances.htm)

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

http://www.epa.gov/opprd001/workplan/reducedrisk.html)

Required Data (link to

http://www.epa.eov/pesticides/reeulatine/data requirements.htm ) and/o r

data waivers. Se e Footnote C.

a) Lis t study (or studies) not included with application

*

>C

X

28
Comments: O

- 3 " en* ffaa,' ! + 0 fe$tStf0/i ? r e j

r

^^//^ b y

* N/A - Not Applicable

Footnotes

A. Durin g the 21 day initial content review, all CSFs wil l be reviewed to determin e

whether all inerts listed, including fragrances, are approved fo r the proposed uses. I f 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 pesticida l uses, correctin g

mistakes on the CSF, etc . or 2) provide the data to support OPP approval of the inert or 3)

withdraw the application. Removin g or substituting an inert ingredient will require a new

CSF and may require submission of data. Al l information, forms, 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 ar e

strongly encouraged to verify tha t all inert ingredients have been approved fo r the

application's use s even if a product is currently registered by consulting th e inert Web

3

29

*Product ingredient source information may be entitled to confidential treatment*
site [link to http://www.epa.gov/opprd001/inerts/lists.html1 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. Som e inert

ingredients ar e no longer approved for food uses or certain types of uses. Th e name

and/or CAS number on a CSF must match the name and CAS number on this web site.

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

delays.

If an inert is not listed on the inert ingredient web site and the applicant believes that the

inert has been approved, the applicant should contact the Inert Ingredient Assessmen t

Branch (IIAB) at inertsbranch@epa.gov and resolve the issue. Copie s of the

correspondence wit h IIAB resolving the issue should accompany the application. Al l

new inerts except PIP inerts are reviewed by IIAB. Th e IIAB should also be contacted

for an y questions on what supporting data needs to be submitted for and the Agency's

inert review process. Question s o n PIP inerts should be directed to the Chief of

Microbial Pesticides Branc h [Link to

http://www.epa.gov/oppbppdl/biopesticides/contacts bppd.html .

When a brand, trade, or proprietary name of an inert ingredient is listed on a CSF,

additional information such as an alternate name of the inert, CAS number or other

information [lin k to http://www.epa.gov/opprd001/inerts/tips.pdf1 must also be included

to enable the Agency to determine if it has been approved. Eac h component o f an inert

mixture (including a fragrance) must be identified. I n some cases, the supplier of the

mixture or fragrance may need to provide this information to the Agency. Prio r to the

Agency's receip t of an application, applicants must arrange with a proprietary mixture or

fragrance supplie r to provide the component informatio n to the Agency or promptly upon

EPA's request. I f the inert ingredients i n a proprietary blend (including fragrances)

cannot or are not identified or provided within the 21-day content review period, th e

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 CSF, the Agency will contact th e

applicant with the following options:

1. Correc t the application by, for instance, correcting the inert's identity or CAS

number, providing documentation tha t 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. Submi t the information and data needed for the Agency to approve the

unapproved inert. I f this option is selected an d implemented, the Agency may

request an extension in the PRIA decision review timeframe to accommodat e

the inert review/approval process;

30
3. Withdra w the application (the Agency retains 25% of the full fe e for the fee

category estimated); or

If none of these options is selected an d implemented b y the applicant withi n the

21 day content review period, the Agency will reject the application and retain

25% of the full fe e of the category identified.

Conventional New Product Application s

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 (R311, R312 or R313), it will contact the applicant with the

following options:

1. Correc t 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. Submi t 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. (Thi s option may change the PRIA

category for the application, which could require a longer decision review

time and a larger fee. I f additional fees ar e due, they must be received by the

Agency within the 21 day content review period.)

3. Withdra w the application (the Agency retains 25% of the full fe e for the fe e

category estimated); or

If none of the above options is selected an d 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 approva l category .

PIP Applications

When the Biopesticide and Pollution Prevention Division identifies an

unapproved inert on a PIP CSF and a request to approve the inert does not

accompany the application, it will contact the applicant with the following

options:

1. Correc t 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. Submi t the information and data needed for the Agency to approve th e

unapproved inert. I f 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. I f this option is selected an d implemented, the

Agency will discuss harmonizing the timeframe for both actions.

5

31
3. Withdra w the application (the Agency retains 25% of the full fe e for the fe e

category estimated); or

If none of the above options is selected an d implemented durin g 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 t o 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 t o pay will be placed into either R301 or

A531. Th e Agency recommends that authorizations of offers t o pay be submitted with

other PRIA application s to avoid delays in the Agency's decision .

C. Biopesticid e applicants are advised to contact the Agency an d discuss study waivers

prior to submitting their application to the Agency. Documentatio n o f such discussions

should be submitted with the study waiver.

32
Inert Issues (85678-RL)

Tracy Jackson to : Catherin e Byr d 03/07/201 1 08:46 AM

From: Trac y Jackson/DC/USEPA/US

To: Catherin e Byrd <Catherine@wagnerreg.com>

Dear Ms. Byrd ,

I am contacting you regarding your submission o f Tribufos 6 (85678-RL). I need the exact ingredient of

the solvent on your Confidential Statemen t o f Formula. Pleas e see attachment below .

Inert Status.doc

If you have any questions I can be reached at 703-308-7227

Tracy Jackson

Macfadden/EPA Contracto r

2777 S. Crystal Drive

Arlington, VA 22202

jackson.tracy@epa.gov

33
UNTTEECD STATES ENVIRONMENTAL PROTECTION AGENCY

\ WASHINGTON , D.C. 2046 0

February 28, 2011

OFFICE OF

PREVENTION, PESTICIDES AND

TOXIC SUBSTANCE S

OPP Decision Number: D-44567 0

EPA File Symbol or Registration Number: 85678-RL

Product Name: TRIBUFO S 6

EPA Receipt Date: 23-Feb-201 1

EPA Company Number: 85678

Company Name: REDEAGL E INTERNATIONAL LLC

CHERYL WAGNER

WAGNER REGULATORY ASSOCIATES, INC.

REDEAGLE INTERNATIONAL LLC

7460 LANCASTER PIKE, SUITE 9, PO Box 640

HOCKESSIN5DE 19707-064 0

SUBJECT: Receip t of Registration Application Subjec t to Registration Service Fee

Dear Registrant:

The Office o f Pesticide Programs has received your application and certification of

payment. I f you submitted data with this application, the results of the PRN-86-5 screen will be

communicated separately . Durin g the administrative screen, the Office o f Pesticide Programs

has determined that this Action is subject to a Pesticide Registratio n Service Fee as defined in

the Pesticide Registration Improvement Act.

The Action has been identified as Action Code: R300

NEW PRODUCT;ME-TOO PRODUC T FAST TRACK;

No additional payment is due at this time.

If you have any questions , please contact the Pesticide Registration Servic e Fee

Ombudsman at (703) 308-9362.

Sincerely, IJUJLA- &

Front End Processing Staf f

Information Technology & Resources Management Division

34
Pay.gov - Online Payment https://www.pay.gov/paygovAg\anents/authorizePlasticCardPawient.htm vngvj l

Online Payment

Step 3: Confirm Payment

Thank you .

Your transaction has been successfully completed.

Pay.gov Tracking Informatio n

Application Name: PRIA Service Fees

Pay.gov Tracking ID: 252L49T2

Agency Tracking ID: 74177456035

Transaction Date and Time: 02/21/2011 17:17 EST

TM Payment Summary

1|2|3

,

: Addres s Informatio n

Account Holder Jameswggner

7460 Lancaster

Billing Address: Pike

Billing Address 2:

City: Hockessin

State / Province: DE

Zip/Postal Code: 19707

Country: USA

Account Information

Card Type: American Express

Card Number: **«*******•) Q18

Decision Number:

Registration

Number:

RedEagle

Company Name: International

Company Number: 85678

Action Code: R300

Payment Amount: $1,434.00

Transaction Date 02/21/2011 17:17

and Time: EST

ofl 2/21/2011 5:18PM

35
R 300 and 30 1

100% identical (repack): YE S or

{If yes, it's a 100 % repack - then

are not required }

(circle one)

chemistry, acute toxicity and efficacy dat a

Data on Group and A and B must be submitted - Group A and B can no t be cited.

Guideline

No.

830.1550

830.1600

830.1650

830.1670

830.1700

830.1750

830.1800

Group A: Produc t Chemistry Data

Study Title

Product Identity & Compositio n

Description of materials used to produce the

product

Description of formulation process

Discussion on the formation o f impurities

Preliminary analysis

Certified limit s (158.345 )

Enforcement analytical metho d

Data

submitted

Yes

X

*

£

A

&

k

&

No

Guideline

No.

830.6302

830.6303

830.6304

830.6314

830.6315

830.6316

830.6317

830.6319

830.6320

830.6321

830.7000

830.7100

830.7300

Group B : Produc t Chemistry Data

Study Title

Color

Physical State

Odor

Oxidation/Reduction (Chemica l

incompatibility)

Flammability

Explodability

Storage stability

Miscibility

Corrosion Characteristics

Dielectric Breakdow n voltag e

PH

Viscosity

Density

Data

submitted

Yes

*

V

1

1

t1 "V

I

i

-f

i

4

i

V

2k

No

36
R 300 and 30 1

New products mus t provide a bridging rationale document . Th e bridging documen t

directs OPP to use a currently registered set of 6 acute toxicity data and label; instead

of submitting product specific data.

Guideline

No.

870.1100

870.1200

870.1300

870.2400

870.2500

870.2600

Acute toxicity (6 pack) /

Study Title /

Acute Oral (LD50) /

Acute Derma l (LD50 )

Acute Inhalatio n (LC50 )

Acute Ey e Irritation \

Acute Dermal Irritation \

Dermal Sensitization ^

Cited

Yes

i/

{/'-

\

w

1, /

/

Efficacy-which guidelin e depends o n the proposed label use and they must cite the

data to be used for the bridging rationale.

A/^f it * ,/,n d

Guideline

No.

810.3100

810.3200

810.3300

810.3400

810.3500

810.3600

810.3800

(/

Efficacy Study Titles

Soil Treatments for Imported Fir e Ants

Livestock, Poultry, Fur and Wool-Bearing

Animal Treatments

Treatments to Control Pest s of Humans

and

Pets

Mosquito, Blac k Fly, and. Biting Midge

(Sand Fly) Treatments

Premises Treatments

Structural Treatments

Methods fo r Efficacy Testing of Termite

Baits

Cited

Yes No Comments

37
February 18,201 1 jy^ m ~T1TTT~^ » A

W IX /\

Document Processing Des k (REGFEE )

ATTN: Ton y Kish, PM 2 2 Wagne r Regulatory Associates, Inc.

Registration Divisio n p -°-Bo* 64 °

U.S. Environmental Protection Agenc y 746 ° Lancaster Pike, Suite 9

Office o f Pesticide Programs (7504P ) Hockessin , Delaware 1970 7

Room S-4900 , On e Potomac Yar d

2777 South Crystal Drive

Arlington, Virginia 22202-4501

Dear Mr. Kish,

Subject: Applicatio n t o register a new end use product containin g a currently registere d activ e ingredien t -

"Tribufos 6"

Wagner Regulatory Associates, Inc. , as agent for RedEagle International LLC (EPA Compan y Number 85678), i s

requesting registration o f the above reference d product. Thi s product is substantially similar to the tribufos product

(DBF 6 Emulsifiable Defoliant) registered by Amvac Chemical Corporation unde r EPA Registration Numbe r 5481 -

9023.

In support of this request, the following documents and studies are attached :

• Lette r fro m RedEagl e Internationa l LLC appointing Wagner Regulatory Associates, Inc. as its agent

• Applicatio n for Pesticide Registration (8570-1 )

• Confidentia l Statement of Formula (8570-4), 2 copies

• Certificatio n with Respect t o Citation of Data (8570-34 )

• Formulator' s Exemptio n Statement (8570-27)

• Dat a Matrix (8570-35)

• Dat a Transmittal Documen t

• Produc t Identity and Composition dat a (3 copies) as outlined in the transmittal document

• Physica l and Chemical Properties dat a (3 copies) as outlined in the transmittal document

• Draf t labeling , 3 copies an d electronic version

• Certificatio n with Respect to Label Integrity

• A copy of the EPA approved labe l for EPA Reg. No. 264-730 (Baye r CropScienc e - Def 6 Emulsifiabl e

Defoliant which was recently transferred to Amvac), and

• A copy of the receipt confirming payment of the required registration fees.

RedEagle International LLC has submitted payment to U.S.EPA in accordance wit h PRIA II Fee Table -

FY11/FY12, fo r action categor y R30 0 - $1,434 .

If you have any questions about this submission, please contact the undersigned at 302-234-2780 o r

catherine@wagnerreg.com.

Respectfully submitted , • • *

Catherine M. Byrd

Agent for RedEagle Internationa l LLC

Enclosures

38
DATA TRANSMITTAL DOCUMEN T

1. Nam e and Address of Submitter

RedEagle Internationa l LL C

c/o Wagner Regulatory Associate s

PO Box 640

Hockessin, D E 1970 7

2. Regulator y Action In Support Of Which This Package Is Submitted

Application fo r Registratio n

Tribufos 6

3. Transmitta l Date

February 18 , 2011

4. Lis t of Submitted Studie s

Vol. 1 : Wagner Regulatory Associates, Inc. (2011) Tribufos 6 - Product Identity and

Composition, Description of Beginning Materials, Manufacturing Process, an d

Discussion o f Formation of Impurities. RedEagle International LLC, Lakeland,

Florida. Non-confidential portion 6 pages, Confidential portion 31 pages.

Vol. 2: Wagne r Regulatory Associates, Inc. (2011) TRIBUFOS 6 - Preliminar y

Analysis, Certified Limits and Enforcement Analytical Method. RedEagle • * • * •

International LLC, Lakeland, Florida. Non-confidential portion 6 pages, Confutential

portion 4 pages. 5* 1 « • *

JJLSJULft •

Vol. 3: Gang , Sun (2011) Final Report Amendment-2 -Tribufos 70.5 % EC fiud-TJs e

Product (EUP) Physical and Chemical Characteristics. Southwest Research»Institute . *•»"• !

San Antonio, TX. Projec t Number 01.14990.03.001. 1 2 pages. »•?.. * . • •

Vol. 4: Wagne r Regulatory Associates, Inc. (2011) Tribufos 6 - Produc t Chemistry •

Data Waivers. RedEagl e International LLC, Lakeland, Florida. 4 pages. !•••! •

Company Official:

_ Catherin r « , • Me M R. Bvr Hd

Name Signatur e

Company Name: Wagne r Regulator y Associates , Inc.

Agent for RedEagle Internationa l LL C

Company Contact:

Catherine M. Bvr d _ _ (302 ) 234-278 0

Name Phon e

39
Phone: (863) 682-6698

Fax: (863) 682-6690

August 1,200 9

To Whom It May Concer n

Dear Sir or Madam:

This letter serves as notification that RedEagle International LLC. has appointed Wagner

Regulatory Associates, Inc. (WRA, Inc.) to serve as the Agent on our company's behalf

regarding all state and federa l regulator y matters relative to products that RedEagl e

International LLC. will register with the U.S. EPA and the states. Please forwar d all

correspondence fo r RedEagle International LLC. and its products to :

Wagner Regulatory Associates, Inc.

P.O. Box 640

Hockessin, DEI 9707-0640

Thank you for your time and assistance. Pleas e feel fre e to call me if you have any

questions.

Respectfully submitted ,

Yingxue Yu

Chief Executive Office r

cc: WRA, Inc. •

•

•

• • •

Address: 1925 E. Edgewood Drive, Lakeland, Florida 33803

40
rorrrm approved. OMB No. 2070-0060, 2070-0057, 2070-010? oroT,, 2070-0122 : , 2070-0164

&EPA

United Slates

Environmental Protection Agency

Washington, DC 20460

Formulator's Exemption Statement

(40 CFR 152.85)

Applicant's Name and Address

RedEagle Internationa l LL C

c/o Wagner Regulatory Associates, Inc .

7460 Lancaster Pike , St e 9

Hockessin, DE 1970 7

EPA File Symbol/Registration Number

85678- /

Product Name

Tribufos 6

Date of Confidential Statement of Formula (EPA For m 8570-4)

02/18/2011

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

(1) This product contains the following activ e ingredient(s) :

Tribufos

<?

(2) O f these, each active ingredient liste d in paragraph (4) is present solely as the result of the use of that active ingredient i n the manufacturing,

formulation or repackaging another product which contains that active ingredient whic h is registered under FIFRA Section 3, is purchased by

us from another person and meets the requirements of 40 CFR section 158.50(e)(2) or (3).

(3) Indicat e by checking (A) or (B) below which paragraph applies :

/I (A ) An accurate Confidential Statemen t of Formula (EPA FOR M 8570-4) for the above identified produc t 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).

OR

~l (B ) The Confidential Statemen t o f Formula (CSF)(EP A Form 8570-4) reference d above and on file with the EPA is complete, current, an

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 Ingredien t

tribufos

Product Name Registratio'n NuTnber

Signature Name and Title

Catherine M . Byrd, Agent

Date

02/18/2011

EPA Form 8570-27 (Rev. 06-2004 ) Copy 1 - EPA

Copy 2 - Applicant copy

41

*Product ingredient source information may be entitled to confidential treatment*
Paperwork Reduction Ac t Notice

The public reporting burden for this collection of information is estimated to average 1.5 . hours per response ,

including familiarization with the form, organizing the necessary information , and completing the form. Sen d

any comments regarding the burden estimate or any other aspect of this collection of information to: Director,

Collection Strategies Division (2822T), U.S. Environmental Protection Agency, 120 0 Pennsylvania Avenue,

N.W., Washington, D C 20460 . Do not send the completed for m to this address.

i • . • .SPA For m 8570-27 (Rev . 06-2004) Reverse Cop y 1 - EPA Copy 2 - Applicant cop y

• •

42
Form Approved OMB Nos. 2070-0060: 2070-0057; 2070-0107; 2070-0122; 2070-0164

UNITED STATES ENVIRONMENTAL PROTECTIO N AGENCY

1200 Pennsylvania Avenue, N.W.

WASHINGTON, D.C. 2046 0

Paperwork Reduction Act Notice: Th e public reporting burden for this collection of information is estimated to average 1.2 5 hours per response for registration

and 0.25 hours per response for reregistration and special review activities, including time for reading the instructions and completing the necessary forms. Sen d

comments regarding burden estimate or any other aspect of this collection of information, includin g suggestions for reducing the burden to: Director, Collection

Strategies Division (2822T), U.S. Environmental Protection Agency, 1200 Pennsylvania Avenue, N.W., Washington, DC 20460. D o not send the completed form

to this address.

Certification with Respect to Citation of Data

Applicant's/Registrant's Name, Address, and Telephone Numbe r

RedEagle International LLC, P.O . Box 640, Hockessin, DE 19707

Active Ingredient(s) and/or representative test comoound(s)

Tribufos

General Use Pattem(s) (list al l those claimed for this product using 40 CFR Part 158)

Terrestrial Non-Food; Terrestrial Foo d

EPA Registration Number/File Symbol

85678-

Date

2/18/2011

Product Name

Tribufos 6

NOTE: If your product is a 100% repackaging of another purchased EPA-registered product labeled for all the same uses on your label, you do not need to

submit this form. Yo u must submit the Formulator's Exemption Statement (EPA Form 8570-27).

D I am responding t o a Data-Call-in Notice, and have included with this form a list of companies sent offers of compensation (the Data Matrix form should

be used for this purpose).

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

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

a list of companies sent offers of compensation (the Data Matrix form

should be used for this purpose). 0 1 am using the selective method of support (or cite-all option

under the selective method), and have included with this form a

completed list of data requirements (the Data Matrix form must be

used).

SECTION II: GENERAL OFFER TO PAY

[Required if using the cite-all method or when using the cite-all option under the selective method to satisfy one or more data requirements]

| </| I hereby offer and agree to pay compensation, to other persons, with regard to the approval of this application, to the extent required by FIFRA.

SECTION III: CERTIFICATION

I certify that this application for registration, this form for reregistration, or this Data-Call-in response is supported by all data submitted or cited in the

application for registration, the form for reregistration, or the Data-Call-in response. I n addition, if the cite-all option or cite-all option under the selective method is

indicated in Section I, this application is supported by all data in the Agency's files that (1) concern the properties or effects 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 i n effect on the date of approval of this application if the application sought the initial registration of a product of identical or similaj T;8rflp*qf ition and

uses . • • • •

• • •

I certify that for each exclusive use study cited in support of this registration or reregistration, that I am the original data submitter or Jiafl^atfe 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 «m the $r1g jriafc|ata

submitter; (b ) I have obtained the permission of the original data submitter to use the study in support of this application; (c ) all^|j(yl£«f eligibly for*

compensation have expired for the study; (d) the study is in the public literature; or (e) I have notified in writing the company that sabjrjjfted the study an* have

offered (I) to pay compensation to the extent required by sections 3(c)(1)(F) and/or 3(c)(2)(B) of FIFRA; and (ii) to commence negotiation s to dele/mfhe Jhe

amount and terms of compensation, if any, to be paid for the use of the study. **!** •

I certify that in all instances where an offer of compensation is required, copies of all offers to pay compensation and evidence of theifjd^|v(ejy.in

accordance with sections 3(c)(1)(F) and/or 3(c)(2)(B) of FIFRA are available and will be submitted to the Agency upon request. Shoul d I fail to produce such

evidence to the Agency upon request, I understand that the Agency may initiate action to deny, cancel or suspend the registration o f my productjn conformity with

FIFRA. ;

I certify that the statements I have made on this form and al attachments to It are true, accurate, and complete. I acknowledge that any

knowingly false or misleading statement may be punishable by fine or imprisonment or both under applicable law .

Signature / i _ . . n Date

02/21/2011

Typed or Printed Name and Title

Catherine M . Byrd, Agent

EPA Form 8570-34 (12-2003) Electronic and Paper versions available. Submit only Paper version.

43
f ^ k \

v& Form Approved OMB No. 2070-0060

UNITED STATES ENVIRONMENTAL PROTECTIO N AGENCY

401 M Street, S.W.

WASHINGTON, D.C. 2046 0

Paperwork Reduction Ac t Notice: Th e public reporting burden for this collection of information is estimated to average 0.25 hours per response for registration activitie s and 0.25

hours per response for reregistration an d special review activities, including time for reading the instruction and completing the necessary forms. Sen d comments regarding the

burden estimate or any other aspect of this collection of information, including suggestions for reducing the burden to: Director, OPPE Information Management Divisio n (2137),

U.S. Environmental Protection Agency, 401 M Street, S.W., Washington D C 20460. D o not send the form to this address.

DATA MATRIX

Date: 2/18/201 1

Applicant's/Registrant's Name and Address: RedEagle International LLC

c/o Wagner Regulatory Associates Inc.

P.O. Box 640

Hockessin, DE 1970 7

EPA Reg No./ File Symbol: 85678 -

Product:

Tribufos 6

Page 1 of 3

Ingredient: Tribufos

>

Guideline Reference Number

PRODUCT SPECIFIC

830.1550, 830.1600, 830.1650 ,

830.1670,

830.1700

830.1750

830.1800

830.6302

830.6303

830.6304

830.6313

830.6314

830.6315

830.6316

830.6317

830.6319

830.6320

830.6321

830.7000

830.7050 ... .

830.7100 I

830.7200 : •

Guideline Study Name

Product identity, composition/Description o f

materials Used to Produce the

Product/Description o f Formulation

Process/Discussion o f Formation of Impurities

Preliminary Analysis

Certification of Limits

Enforcement Analytical Method

Color

Odor

Physical Stat e

Stability to Normal & Elevated Temperature s

Oxidation/Reduction

Flammability

Explodability

Accelerated Storag e Stability

Miscibility* ;

CoH-osiof Characteristic s

Dielectric Urea£3own Voltage

pH

iiV/Visible4»$ht At>S$rpifa i

Viscoaty" .• . .* 1 1

Melting^pint * "• " "• *

MRID Number Submitter

RedEagle International LLC

RedEagle International LLC

RedEagle International LLC

RedEagle International LLC

RedEagle International LLC

RedEagle International LLC

RedEagle International LLC

RedEagle International LLC

RedEagle International LLC

RedEagle International LLC

RedEagle International LLC

RedEagle International LLC

RedEagle International LLC

RedEagle International LLC

RedEagle International LLC

RedEagle International LLC

RedEagle International LLC

RedEagle International LLC

RedEagle International LLC

Status

Own

Own

Own

Own

Own

Own

Own

Own

Own

Own

Own

Own

Own

Own

Own

Own

Own

Own

Own

Note " H

1

J

1

H

^ Nam e and Title

FfltflMJAuu W-- fyw — Catherin e M-

 Byrd'

(MMWWI^' <^ 7 Agen t for RedEagle International LLC Signature ' 6 &

Date

2/18/2011

t

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

44
/S*% For m Approved OMB No. 2070-0060

{•S&/ UNITE D STATE S ENVIRONMENTAL PROTECTIO N AGENCY

"""""^ 40 1 M Street, S.W .

WASHINGTON, D.C . 2046 0

Paperwork Reduction Ac t Notice: Th e public reporting burden for this collection of information is estimated to average 0.25 hours per response for registration activities and 0.25

hours per response for reregistration and special review activities, including time for reading the instruction an d completing the necessary forms. Sen d comments regarding the

burden estimate or any other aspect of this collection o f information, including suggestions for reducing the burden to: Director, OPPE Information Management Division (2137),

U.S. Environmental Protection Agency, 401 M Street, S.W. , Washington DC 20460. D o not send the form to this address.

DATA MATRI X

Date: 2/18/201 1

Applicant's/Registrant's Name and Address: RedEagle International LLC

c/o Wagner Regulatory Associate s Inc.

P.O. Box 640

Hockessin, DE 1970 7

EPA Reg No./ File Symbol: 85678 - Pag e 2 of 3

Product:

Tribufos 6

Ingredient: Tribufo s

Guideline Reference Numbe r

830.7220

830.7300

830.7370

830.7520

830.7550

830.7840

830.7840

830.7950

ACUTE TOXICITY &

GENERIC DATA

• •• i

•

Guideline Study Name

Boiling Point

Relative Density

Dissocation Constants i n Water

Particle Size, Fiber Length, and Diamete r

Distribution

Octanol/Water Partitio n Coefficien t

Solubility in Organic Solvents

Water Solubility

Vapor Pressur e

• * •' • •

• • • • . . • • • •• •

:• •' • "I : "I s :*:

MRID Number

Cite All

Submitter

RedEagle International LLC

RedEagle Internationa l LLC

RedEagle Internationa l LLC

RedEagle International LLC

RedEagle International LLC

RedEagle International LLC

RedEagle International LLC

RedEagle International LLC

Agricultural Handlers Exposure

Task Force

Macon, MO

Agricultural Reentry Task Force

Washington, DC

Amvac Chemical Corporation

Newport Beach, CA

BASF Sparks LLC

Research Triangle Park, NC

Bayer Cropscience LP

Research Triangle Park, NC

Bayer Corp

Kansas City, MO

Status

Own

Own

Own

Own

Own

Own

Own

Own

Pay

Note H

m

1

Signature

Name and Title

Catherine M. Byrd,

Agent for RedEagle International LLC

Date

2/18/2011

EPA Form 8570-35 (9-97) Electroni c and Paper versions available. Submit only Paper version. Agency Internal Us e Copy

45
/5£% For m Approved OMB No. 2070-0060

l^SSy UNITE D STATES ENVIRONMENTAL PROTECTIO N AGENCY

"'"^ 40 1 M Street, S.W .

WASHINGTON, D.C. 2046 0

Paperwork Reduction Ac t Notice: Th e public reporting burden for this collection of information is estimated to average 0.25 hours per response for registration activities an d 0.25

hours per response for reregistration an d special review activities, including time for reading the instruction and completing the necessary forms. Sen d comments regarding the

burden estimate or any other aspect of this collection of information, includin g suggestions fo r reducing the burden to: Director, OPPE Information Management Division (2137),

U.S. Environmental Protection Agency , 401 M Street, S.W. , Washington DC 20460. D o not send the form to this address.

DATA MATRIX

Date: 2/18/201 1

Applicant's/Registrant's Nam e and Address: RedEagl e International LLC

c/o Wagner Regulatory Associates Inc.

P.O. Box 640

Hockessin, DE 1970 7

EPA Reg No./ File Symbol: 85678 -

Product:

Tribufos 6

Page 3 of 3

Ingredient: Tribufos

Guideline Reference Numbe r Guideline Stud y Name MRID Number Submitter

FIFRA Endangered Species Task

Force, LLC

Washington, DC

Outdoor Residential Exposure Tas k

Force, LLC

Washington, DC

Spray Drift Task Forc e

Washington, DC

Status Note ~ |

Footnotes: 1 ) Certificatio n of Limits is provided in the Confidential Statement of Formula EPA form 8574- 4

Signature

Name and Title

Catherine M. Byrd,

Agent for RedEagle International LLC

Date

2/18/2011

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

46
/j*\ For m Approved OMB No. 2070-0060

U3S/ UNITE D STATES ENVIRONMENTAL PROTECTIO N AGENCY

401 M Street, S.W .

WASHINGTON, D.C . 2046 0

Paperwork Reduction Ac t Notice: Th e public reporting burden for this collection of information is estimated to average 0.25 hours per response for registration activitie s and 0.25

hours per response for reregistration an d special review activities, includin g time for reading the instruction and completing the necessary forms. Sen d comments regarding th e

burden estimate or any other aspect of this collection o f information, including suggestions fo r reducing the burden to: Director, OPPE Informatio n Management Divisio n (2137),

U.S. Environmental Protection Agency, 401 M Street, S.W. , Washington DC 20460. D o not send the form to this address.

DATA MATRIX

Date: 2/18/201 1

Applicant's/Registrant's Name and Address: RedEagle Internationa l LLC

c/o Wagner Regulatory Associate s Inc.

P.O. Box 640

Hockessin, DE 1970 7

EPA Reg No./ File Symbol: 85678 - Page 1 of 3

Product:

Tribufos 6

Ingredient: Tribufos

Guideline Reference Numbe r

PRODUCT SPECIFIC

830.1550, 830.1600 , 830.1650 ,

830.1670,

830.1700

830.1750

830.1800

830.6302

830.6303

830.6304

830.6313

830.6314

830.6315

830.6316

830.6317

830.6319

830.6320

830.6321

830.7000

830.7050

830.7100

830.7200

Guideline Study Name

Product identity, composition/Description o f

materials Used to Produce the

Product/Description o f Formulation

Process/Discussion o f Formation of Impurities

Preliminary Analysis

Certification o f Limits

Enforcement Analytical Method

Color

Odor

Physical Stat e

Stability to Normal & Elevated Temperature s

Oxidation/Reduction

Flammability

Explodability

Miscibility • • ;

Corrosion Characteristic s • . * '

Dielectric Breakdown Voltage

pH

UV/Visible Light Absorption • • !

Viscosity • ! . * .*

Melting Point • * **

MRID Number

• • • • • • • • • • • ••

TT. •• • •

• . • • • : * • • • • * J

• •

Submitter

RedEagle International LLC

RedEagle International LLC

RedEagle International LLC

RedEagle International LLC

RedEagle International LLC

RedEagle International LLC

RedEagle International LLC

RedEagle International LLC

RedEagle International LLC

RedEagle International LLC

RedEagle International LLC

RedEagle International LLC

RedEagle International LLC

RedEagle International LLC

RedEagle International LLC

RedEagle International LLC

RedEagle International LLC

RedEagle International LLC

RedEagle International LLC

Status

Own

Own

Own

Own

Own

Own

Own

Own

Own

Own

Own

Own

Own

Own

Own

Own

Own

Own

Own

Note ~ f

1

J

1

- Nam e and Title

/1/^iUi/t! , ^ VI fAJfTL ^ Catherin e M. Byrd, WtiW*> //L

 0y*— Agen t for RedEy

agi; Intemational LLC

Signature ' &

Date

2/18/2011

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

47
/ ^* i

<&

Form Approved OMB No. 2070-0060

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

401 M Street, S.W.

WASHINGTON, D.C. 2046 0

Paperwork Reduction Ac t Notice: Th e public reporting burden for this collection of information is estimated to average 0.25 hours per response for registration activitie s and 0.25

hours per response fo r reregistration and special review activities, including time for reading the instruction and completing the necessary forms. Sen d comments regarding the

burden estimate or any other aspect of this collection of information, including suggestions for reducing the burden to: Director, OPPE Information Management Division (2137),

U.S. Environmental Protection Agency, 401 M Street, S.W. , Washington DC 20460. D o not send the form to this address.

DATA MATRIX

Date: 2/18/201 1

Applicant's/Registrant's Name and Address: RedEagle International LLC

c/o Wagner Regulatory Associates Inc.

P.O. Box 640

Hockessin, DE 1970 7

EPA Reg No./ File Symbol: 85678 -

Product:

Tribufos 6

Page 2 of 3

Ingredient: Tribufos

Guideline Reference Number

830.7220

830.7300

830.7370

830.7520

830.7550

830.7840

830.7840

830.7950

ACUTE TOXICITY

Guideline Study Name

Boiling Point

Relative Density

Dissocation Constants in Water

Particle Size, Fiber Length, and Diameter

Distribution

Octanol/Water Partitio n Coefficien t

Solubility in Organic Solvents

Water Solubility

Vapor Pressure

• •

• •• • • ' • •

••• •• • • • • I • • . • • " .

MRID Number

Cite All

• • • • •

• • • • • • • • • •

••• •• • *

• . '

• • • : :

Submitter

RedEagle International LLC

RedEagle International LLC

RedEagle International LLC

RedEagle International LLC

RedEagle International LLC

RedEagle International LLC

RedEagle International LLC

RedEagle International LLC

Agricultural Handlers Exposure

Task Force

Macon, MO

Agricultural Reentry Task Force

Washington, DC

Amvac Chemical Corporation

Newport Beach, CA

BASF Sparks LLC

Research Triangle Park, NC

Bayer Cropscience LP

Research Triangle Park, NC

Bayer Corp

Kansas City, MO

Status

Own

Own

Own

Own

Own

Own

Own

Own

Pay

Note " H

-

^

Signature

Name and Title

Catherine M. Byrd,

Agent for RedEagle International LLC

Date

2/18/2011

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

48
/ A i j

^&

•**mot*

Form Approved OMB No. 2070-006 0

UNITED STATES ENVIRONMENTAL PROTECTIO N AGENCY

401 M Street, S.W .

WASHINGTON, D.C. 2046 0

Paperwork Reduction Ac t Notice: Th e public reporting burden for this collection of information is estimated to average 0.25 hours per response for registration activitie s and 0.25

hours per response for reregistration and special review activities, including time for reading the instruction and completing the necessary forms. Sen d comments regarding the

burden estimate or any other aspect of this collection o f information, including suggestions for reducing the burden to: Director, OPPE Information Management Division (2137),

U.S. Environmental Protection Agency, 401 M Street, S.W. , Washington DC 20460. D o not send the form to this address.

DATA MATRI X

Date: 2/18/201 1

Applicant's/Registrant's Name and Address: RedEagle International LLC

c/o Wagner Regulatory Associate s Inc .

P.O. Box 640

Hockessin, D E 1970 7

EPA Reg No./ File Symbol: 85678 - Page 3 of 3

Product:

Tribufos 6

Ingredient: Tribufos

Guideline Reference Numbe r Guideline Study Name MRTO Number Submitter

FIFRA Endangered Species Task

Force, LLC

Washington, DC

Outdoor Residential Exposure Task

Force, LLC

Washington, DC

Spray Drift Task Forc e

Washington, DC

Status Note ^

Footnotes: 1 ) Certificatio n of Limits is provided i n the Confidential Statement o f Formula EPA form 8574- 4

: : • •• • • • •

• • » • . • . • •

Signature

Name and Title

Catherine M. Byrd,

Agent for RedEagle International LLC

Date

2/18/2011

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

49
/*i'% For m Approved OMB No. 2070-0060

{^S&J UNITE D STATES ENVIRONMENTAL PROTECTIO N AGENCY

401 M Street, S.W .

WASHINGTON, D.C. 2046 0

Paperwork Reduction Ac t Notice: Th e public reporting burde n for this collection of information is estimated t o average 0.2 5 hours per response fo r registration activities and 0.25

hours per response for reregistration an d special review activities, includin g time for reading the instruction and completing the necessary forms. Sen d comments regarding the

burden estimate or any other aspect of this collection o f information, including suggestions for reducing the burden to: Director, OPPE Information Management Divisio n (2137),

U.S. Environmental Protection Agency , 401 M Street, S.W., Washington D C 20460. D o not send the form to this address.

DATA MATRIX

Date: 2/18/201 1

Applicant's/Registrant's Name and Address: RedEagle International LLC

c/o Wagner Regulatory Associates Inc .

P.O. Box 640

Hockessin, DE 1970 7

EPA Reg No./ File Symbol: 85678 -

Product:

Tribufos 6

Page 1 of 3

Ingredient: Tribufos

Guideline Referenc e Numbe r Guidelin e Study Name Submitter Status Note

=^

PRODUCT SPECIFIC

RedEagle International LLC

RedEagle International LLC

RedEagle International LLC

RedEagle Internationa l LLC

RedEagle International LLC

RedEagle International LLC

RedEagle International LLC

RedEagle Internationa l LLC

RedEagle International LLC

RedEagle International LLC

RedEagle International LLC

RedEagle International LLC

RedEagle International LLC

RedEagle International LLC

RedEagle International LLC

RedEagle International LLC

RedEagle International LLC

RedEagle International LLC

RedEagle International LLC

RedEagle International LLC

RedEagle International LLC

Own

Own

Own

Own

Own

Own

Own

Own

Own

Own

Own

Own

Own

Own

Own

Own

Own

Own

Own

Own

Own

Own

Name and Title Catherine M-

 Byrd'

Agent for RedEagle International LLC

Date

2/18/2011

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

50
/*i"\ For m Approved OMB No. 2070-0060

i58£/ UNITE D STATES ENVIRONMENTAL PROTECTION AGENCY

401 M Street, S.W .

WASHINGTON, D.C. 2046 0

Paperwork Reduction Ac t Notice: Th e public reporting burden for this collection of information is estimated to average 0.25 hours per response for registration activities and 0.25

hours per response for reregistration and special review activities, including time for reading the instruction and completing the necessary forms. Sen d comments regarding the

burden estimate or any other aspect of this collection of information, including suggestions for reducing the burden to: Director, OPPE Information Management Division (2137),

U.S. Environmental Protection Agency, 401 M Street, S.W., Washington DC 20460. D o not send the form to this address.

DATA MATRI X

Date: 2/18/201 1

Applicant's/Registrant's Name and Address: RedEagle International LLC

c/o Wagner Regulatory Associates Inc.

P.O. Box 640

Hockessin, DE 1970 7

EPA Reg No./ File Symbol: 85678 -

Product:

Tribufos 6

Page 2 of 3

Ingredient: Tribufos

Guideline Reference Numbe r Guideline Study Name Submitter

RedEagle International LLC

RedEagle International LLC

RedEagle International LLC

RedEagle International LLC

RedEagle Internationa l LLC

Agricultural Handlers Exposure

Task Forc e

Macon, MO

Agricultural Reentr y Task Force

Washington, DC

Amvac Chemical Corporation

ort Beach, CA

BASF Sparks LLC

Research Triangle Park, NC

Bayer Cropscience LP

Research Triangle Park, NC

Bayer Corp

Kansas City, MO

FIFRA Endangered Species Tas k

Force, LLC

Washington, DC

Status

Own

Own

Own

Own

Own

Pay

Note

Signature

Name and Title

Catherine M. Byrd,

Agent for RedEagle Internationa l LLC

Date

2/18/2011

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

51
/*i'\ For m Approved OMB No. 2070-0060

\5SS/ UNITE D STATES ENVIRONMENTAL PROTECTIO N AGENCY

401 M Street, S.W .

WASHINGTON, D.C . 2046 0

Paperwork Reduction Ac t Notice: Th e public reporting burden for this collection of information is estimated to average 0.25 hours per response for registration activitie s and 0.25

hours per response for reregistration an d special review activities, including time for reading the instruction an d completing the necessary forms . Sen d comments regarding the

burden estimate or any other aspect o f this collection o f information, including suggestions fo r reducing the burden to: Director, OPPE Information Management Divisio n (2137),

U.S. Environmental Protection Agency , 401 M Street, S.W., Washingto n DC 20460. D o not send the form to this address.

DATA MATRIX

Date: 2/18/201 1

Applicant's/Registrant's Name and Address: RedEagle International LLC

c/o Wagner Regulatory Associates Inc .

P.O. Box 640

Hockessin, DE 1970 7

EPA Reg No./ File Symbol: 85678 - Page 3 of 3

Product:

Tribufos 6

Ingredient: Tribufos

Guideline Reference Number Guideline Study Name Submitter

Outdoor Residential Exposure Tas k

Force, LLC

Washington, DC

Spray Drift Task Force

Washington, DC

Status Note

Footnotes: 1) Certificatio n of Limits is provided i n the Confidential Statemen t of Formula EPA form 8574-4

• •

•

Signature

Name and Title

Catherine M. Byrd,

Agent for RedEagle International LLC

Date

2/18/2011

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

52
Certification with Respect to Label Integrity

version: 9/11/0 2

I certify that the information (including, but not limited to, text, tables, and graphics)

contained in the electronic file identified below by file name and submitted with this

certification is the same information as that on the paper copies of these documents

included with this submission.

PROPOSED LABEL

EPA Registration #

85678-

Date Submitted

to EPA

02/18/2011

Electronic file name

85678-XXXXX-20110218.Vl.pdf

• ••• • •

I certify that the statements that I have made on this form are true, acfcurlrtf, and .

complete. I acknowledge that any knowingly false or misleading statements miy'be*

punishable by fine or imprisonment or both under applicable law . "•• *

Signature

02/18/2011

Date

Catherine M. Byrd

Name (typed)

Agent for RedEagle International LLC

Title

53
483963-00

February 18,201 1

Document Processing Des k (REGFEE)

ATTN: Ton y Kish, PM 2 2 - Wagne r Regulatory Associates, Inc.

Registration Division P-O . Box 640

U.S. Environmental Protection Agenc y 746 0 Lancaster Pike, Suite 9

Office o f Pesticide Programs (7504P) Hockessin , Delaware 1970 7

Room S-4900, One Potomac Yar d

2777 South Crystal Drive

Arlington, Virginia 22202-450 1

Dear Mr. Kish,

Subject: Applicatio n t o register a new end use product containing a currently registere d active ingredient -

"Tribufos 6 "

Wagner Regulatory Associates, Inc., as agent for RedEagle International LLC (EPA Company Number 85678), is

requesting registration o f the above referenced product. Thi s product is substantially simila r to the tribufos product

(DBF 6 Emulsifiable Defoliant) registered by Amvac Chemical Corporation under EPA Registration Number 5481-

9023.

In support of this request, the following documents and studies are attached:

Letter from RedEagle Internationa l LLC appointing Wagner Regulatory Associates, Inc. as its agent

Application for Pesticide Registratio n (8570-1)

Confidential Statemen t of Formula (8570-4), 2 copies

Certification with Respect to Citation of Data (8570-34)

Formulator's Exemptio n Statemen t (8570-27 )

Data Matrix (8570-35)

Data Transmittal Document

Product Identity and Composition data (3 copies) as outlined in the transmittal document

Physical and Chemical Properties dat a (3 copies) as outlined in the transmittal document

Draft labeling, 3 copies and electronic version

Certification with Respect to Label Integrity

A copy of the EPA approved label for EPA Reg. No. 264-730 (Baye r CropScience - Def 6 Emulsifiable

Defoliant which was recently transferred to Amvac), and

• A copy of the receipt confirming payment of the required registration fees.

RedEagle International LLC has submitted payment to U.S.EPA in accordance with PRIAII Fee Table -

FY11/FY12, for action category R30 0 - $1,434.

If you have any questions about this submission, please contact the undersigned at 302-234-2780 o r

catherine@wagnerreg.com.

Respectfully submitted ,

Catherine M. Byrd

Agent for RedEagle International LLC

Enclosures

54
DATA TRANSMITTAL DOCUMEN T

1. Nam e and Address of Submitter

RedEagle International LL C

c/o Wagner Regulator y Associate s

PO Box 640

Hockessin, D E 19707

2. Regulator y Action In Support Of Which This Package Is Submitted

Application fo r Registratio n

Tribufos 6

3. Transmitta l Date

February 18 , 2011

4. Lis t of Submitted Studies

Vol. 1: Wagne r Regulatory Associates, Inc. (2011) Tribufos 6 - Product Identity and

48398301 Composition , Description of Beginning Materials, Manufacturing Process, and

Discussion of Formation of Impurities. RedEagle International LLC, Lakeland,

.. Florida . Non-confidential portion 6 pages, Confidential portion 31 pages.

Vol. 2: Wagne r Regulatory Associates, Inc. (2011) TRIBUFOS 6 - Preliminar y

48396302 Analysis , Certified Limits and Enforcement Analytical Method. RedEagle

International LLC, Lakeland, Florida. Non-confidential portion 6 pages, Confidential

portion 4 pages.

Vol. 3: Gang , Sun (2011) Final Report Amendment-2 -Tribufos 70.5 % EC Erd-dse

48398303 Pr °duct (EUP) Physical and Chemical Characteristics. Southwest Research In

San Antonio, TX. Project Number 01.14990.03.001. 12 pages.

Vol. 4: Wagne r Regulatory Associates, Inc. (2011) Tribufos 6 - Produc t Chemistry

48398304 Dat a Waivers. RedEagle International LLC, Lakeland, Florida. 4 pages.

Company Official:

M.BV.

Name Signatur e

Company Name: Wagne r Regulatory Associates, Inc.

Agent for RedEagle Internationa l LLC

Company Contact:

Catherine M. Bvr d _ _ (302 ) 234-2780

Name Phon e

55
Please read instructions on reverse before completi FormAppn n l

United States

Environmental Protection Agency

Washington, DC 2046 0

X

2070-0060. Approva l expires 05-31-98

Amendment

Other

OPP Identifier Numbe r

Application for Pesticide - Section I

1. Company/Product Number

85678-

4. Company/Produc t (Name )

RedEagle International LLC/Tribufos 6

2. EP A Product Manager

Tony Kish

3. Propose d Classification

PM#

22

None Restricted

5. Nam e and Address of Applicant (Include Zip Code)

RedEagle International LLC

c/o Wagner Regulatory Associates , inc .

P.O. Bo x 640

Hockessin, DE 19707

Check if this is a new address

6. Expedite d Review. I n accordance with FIFRA Section 3(c)(3)

(b)(l), my product is similar or identical in composition and labelin g

to:

EPA Reg. No. 5481-902 3

Product Name: DE F 6 Emulsifiable Defoliant

Section - I I

[~] Amendmen t - Explain below.

[~~| Resubmissio n in response to Agency letter dated .

|~"| Notificatio n - Explain below.

|~| Fina l printed labels in response to

Agency letter dated

fiTl "M e Too" Application.

[—1 Othe r - Explain below.

Explanation: Us e additional page(s) if necessary. (Fo r Section I and Section II.)

Section -

1. Materia l This Product Will Be Packaged In:

Child-Resistant Packaging

Yes*

No

* Certification must

be submitted

Unit Packagin g

Yes

X No

If "Yes" No . per

Unit Packaging wgt. containe r

Water Soluble Packagin g

Yes

X No

If "Yes"

Package wgt

No. per

container

2. Typ e of Container

Metal

X Plastic

Glass

Paper

Other (Specify) HOPE lined bags

3. Locatio n of Net Contents Informatio n

| X | Label | | Container

4. Size(s ) Retai l Container

2.5 gallons, 30 gallons

5. Locatio n of Label Direction s

On Label

On Labeling accompanyin g product

6. Manne r in Which Label is Affixed to Produc t Lithograph

Paper glued

Stenciled

Other

• • •

Section - IV

1. Contac t Point (Complete items directly below for identification of individual to be contacted, if necessary, to°proce&ttii£ application.) Klnwvn TIAI TM T«l^. ~ l?^~Z^ft* /! « A |A~J»* 4\% A~ f»«-l~ \

Name

Catherine M. Byrd

Title

Agent for RedEagle International LLC

Telephone IN* . (Include ftte a Code )

(302) 234 2780

Certification

I certify that the statements I have made on this form and all attachments thereto are true, accurate and complete.

I acknowledge that any knowingly false or misleading statemen t may be punishable by fine or imprisonment or

both under applicable law.

2. Signatur e

4. Type d Name

Catherine M. Byrd

3. Titl e

Agent for RedEagle International LLC

5. Dat e

2/21/2011

& JBat e Application

'Received *

"(Stamped) • •

This is a reproduction of EPA Form 8570-1 (Rev . 8-94) Previous editions are obsolete.

56
Pages 57-59 - *Confidential Statements of Formula may be entitled to confidential treatment*