# EPA Registration Number 66330-364

# ~_ 66330-364 lillilli/ll Ililllllllllllil nnn"l-;O'"'l"'C'-"

# / ,

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# Material to 

# be adQed to an e-Jacket/Jacket

Reg. No. 

# lrJo330-!304

Description:

# (eCe~pstro::;hDO
1.

# ~acement within the e-Jacket/jacket:

# ~efault: (chronological, top 

# = newest)

o File 

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

# 45")

2.

# ~end to Data Extraction contractors this material:

# ~ Newly stamped accepted label 

# 0' / Notification**~** 

# NewCSF

o Other:

____________ _

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



# Reviewer's 

# N am e;.: 

# """';':{(lc)'1lWlilltY..<-.LJt.L01l1.!**;.l:~_** 

# Phone: ] 

# 03 3l.f 703& 

# I Division: 

# R.O/HB

Date: 12-fJ ..::;\0+/-"-'0:....<9

_______ -

Created August 19,2008

### ! 

### U.S. ENVIRONMENTAL PROTECTION EPA Reg. Number. Date of Issuance: ..sr-,"(ED ST"Ili>", 

### AGENCY 

# f**~ ~**  

### Office of Pesticide Programs 66330-364

### .~. Registration Division (7505P) 

# \ :i DEC -7 ;:JO;1**~( "RO'I~¢**  

### Ariel Rios Building 1200 Pennsylvania Ave., NW Washington, D.C. 20460

NOTICE OF PESTICIDE: Tenn of Issuance ;



### _ Registration Name ofPestidde Product: 

## --.2l Reregistration Thidiazuron-Diuron 4.5SC (under FIFRA, as amended) Cotton Defoliant Name and Address of Registrant (include ZIP Code): Arysta LifeScience North America, LLC 15401 Weston Parkway, Suite 150 Cary, NC 27513 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. In 

### 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 inno way to be construed as an endorsement or recommendation of this product by the Agency. 

### In 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. The 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 reregistered in accordance with FIFRA provided that you:


### I) Submit and/or cite all data required for registration/reregistration review of your product when the Agency requires all registrants of similar products to submit data.

Signature of Approving Official: Date: 

# 1:1/
DFC 

## -i**r~** •. _.'_ r ;. 

### Joanne MilIer Senior Registration Specialist Herbicide Branch, Team 23 Registration Division (7505P)

### Page 2 

### EPA Reg. 66330-364

2. Per the acute toxicity review, the signal word currently on Page 1 of the label "DANGER"
must be revised to read "CAUTION."

3. Per the acute toxicity review, the Hazards to Humans and Domestic Animals statements on Pages 2 and 9 of the label must be revised to read: "CAUTION Harmful if swallowed."

4. Per the Diuron and Thidiazuron REDs, the handler PPE section must be revised to read:

"Some materials that are chemical-resistant to this product are made of barrier laminate or butyl rubber. If you want more options, follow the instructions for category 

### [XXXX] on an EPA chemical-resistance category selection chart.

All pilots, flaggers and groundboom applicators must wear: Long-sleeved shirt and long pants, and Shoes plus socks.

All mixers, loaders, other applicators, and other handlers must wear: Long-sleeved shirt and long pants, Shoes plus socks, Chemical-resistant gloves, A NIOSH-approved dust/mist filtering respirator with any N, R, P or HE filter or an NIOSHapproved dust/mist filtering respirator with approval number prefix TC-21 C, Chemical-resistant apron when mixing, loading, or cleaning equipment or spills.

See engineering controls for additional requirements."

Note: The appropriate chemical-resistant category must be added to the first paragraph of this section of the labeL

5. Per the Diuron RED, the General Application and Restriction text "Protected handlers only

are allowed in the area during application" currently on the label must be revised to read "Only protected handlers may be in the area during application."

6. The text "for cotton produced 

### in arid condition, apply Thidiazuron-Diuron at a rate of 6.4 to 16 fluid ounces (.37Ibs 

### ai thidiazuron) per acre plus other cotton defoliant products 

### at a rate of 21 to 42 fluid Ounces per acre" must be revised because the rates exceed the maximum allowable application rates as specified on Page 31 of the RED (maximum 5.3 

### ozlA). Delete "21 to 42 fluid ounces per acre" or specify specific product names.)



### Page 3 EPA Reg. 66330-364

The rate restriction text on the label must be revised to 

### read as specified below and any conflicting text must be deleted:

"Under nonnal conditions: The maximum application rate is 0.125 Ibs ai 

### thidiazuron per acre. The maximum annual application rate is .3 Ibs ai thidiazuron per acre per year.
During periods of rank growth/high fertilizer conditions, extended periods of rain or low temperatures, and on full season cotton varieties: The maximum application rate is .2 Ibs ai thidiazuron per acre. The maximum annual application rate is 0.3 Ibs ai 

### thidiazuron per acre per year."

7. On page 3 of the label, under SPRAY DRIFT MANAGEMENT, for item 

### "j", add the qualifying phrase"

... except as noted for lettuce and citrus" since without qualification the text would conflict with the lettuce and citrus restrictions. The RED also requires the additional text:

"(In general, a decrease 

### in droplet size or increase in wind speed at the time of application will result in risk to non-target organisms. Alternatively, if droplet size is coarser or wind speeds are lower, exposures due to drift would be reduced)."

Note: The rotational crop and plant back sections must be moved from the SPRAY DRIFT MANAGEMENT section to the DIRECTIONS FOR USE section.

8. On page 4 of the label, in the last bullet of the first paragraph and the second to last bullet of the second paragraph, revise the phrase "This product should not be applied

... " to "Do not apply this product

... ".

9. Delete "General" from "General Information" on page 2. On page 3, change "the spray boom should be" to "the spray boom must be". Change "Inmature crops should not be" to "Inmature crops must not be".

1 

### O. To the Agricultural Use Requirements Box delete "Thidiazuron products can not

... would be reduced".

11. Add "to the extent consistent with applicable law" in front of "Arysta LifeScience North America, LLC assumes no".

A stamped copy of the label is enclosed for your records. You must submit one copy of the final printed label before you release the product for shipment. Products shipped after 12 months from the date of this letter or the next printing of the label whichever occurs first, must bear the new revised label. If these conditions-are not complied with, the registration will be subject to cancellation in accordance with FIFRA. Your release for shipment of the product constitutes

### Page 4 EPA Reg. 66330-364



### acceptance of these 

### conditions. 

## This label supersedes all other previously accepted labels. 

## If you have any questions please call Erik Kraft at 703-308-9358 or email atKraft.Erik@epa.gov.

### )

RED 

### + PR Notice 2007-4


# THIDIAZURON-DIURON 4.SSC
COTTON DEFOLIANT
For Agricultural Use Only ACTIVE INGREDIENTS: Thidiazuron: N-phenyl-N'-1 ,2,3-thidiazol-5-ylurea*

..... '

..................... 36.06% Diuron: 3-(3,4-dichlorophenyl)-1, 1-dimethylurea*

.................... ' '

.................. ,' '

........ ,"

.......... 18.04% Other Ingredients:

.................. '

......... ,'

.......... ,'

........ ' '

........ '

..................... '

...................... 45.90% 

### TOTAL 100.00%

Contains 3 lb. Thidiazuron per gallon and 

### i.Slb. Diuron per gallon

KEEP OUT OF REACH OF CHILDREN DANGER 

### Si usted no entiende la etiqueta, busque a alguien para que se la expJique a usted en detalle. (If 

### you**d~not** 

### understand this label, find someone to explain it to you in detail.)

FIRST AID IF SWALLOWED: 

## • Immediately call a poison control center or doctor for treatment advice.


## • Do not induce vomiting unless told to do SO by a pOison control center or doctor.


## • Have person sip a glass or water if able to swallow. 

# • Do not Qive anvthinq bv mouth to an unconscious person. 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. NOTE 

### TO PHYSICIAN: Probable mucosal damage may contraindicate the use of gastric lavage. HOT UNE NUMBER Have the product container or label with you when calling a poison control center or doctor

or going for treatment EMERGENCY NUMBERS: FOR 24- HOUR EMERGENY MEDICAL ASSISTANCE CALL: 1-866-303-6952 FOR CHEMICAL EMERGENCY: Spill, leak, fire, exposure, or accident call CHEMTREC 1-800-424-9300

SEE INSIDE (SIDE PANEL) FOR ADDITIONAL PRECAUTIONS AND USE DIRECTIONS

EPA Reg_ No_ 66330-364 AD092107



### ACCEPTED with COMMENTS In EPA Letter Dated: 

## D

Fr

- 

## 7 ,"""

- " . Ullderthe Federal inseclicide. Fungicide. and RodenlicideAct

as amended, for lhe peslicide

. registered under EPA Reg. No. EPA Est. No. 51036-GA-001 NET CONTENTS:

__ _
Manufactured for: Arysta LifeScience North America, LLC 

### 15401 Weston Parkway, Suite 

### 150 Cary, NC 27513

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## . ' ,

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### ",

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### , 

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, , , , Filename; Thidiazuron-Diuron 4.5SC (364-021607) AD092107 RED + PR 2007-4 (Clean).doc Page I

### )

PRECAUTIONARY STATEMENTS HAZARDS TO HUMANS AND DOMESTIC ANIMALS DANGER RED 

### + PR Notice 2007-4

Fatal 

### if swallowed. Wash thoroughly with soap and water after handling and before eating, drinking, chewing gum, or using tobacco.

PERSONAL PROTECTIVE EQUIPMENT (PPE) 

### All 

### mixers, loaders, and applicators must wear:

• Long-sleeved shirt

• Long pants

• Shoes and socks

• Chemical-resistant gloves, such as barrier laminate or butyl rubber See Engineering Controls for Requirements

USER SAFETY REQUIREMENTS Follow manufacturer's instructions for cleaning/maintaining PPE. If no such instructions for washables exist, use detergent and hot water. Keep and wash PPE separately from other laundry.

ENGINEERING CONTROLS STATEMENT Engineering Controls for Aerial Application: Enclosed Cockpits Engineering Controls: Pilots must use an enclosed cockpit that meets the requirements listed in the WPS for agricultural pesticides [40 CFR 170.240(d)(6)) When handlers use closed systems, enclosed cabs, or aircraft in a manner that meets the requirements listed in the Worker Protection Standard (WPS) for agricultural pesticides [40 CFR 170.240 (d) (4-6)1, the handler PPE requirements may be reduced or modified as specified in the WPS. Pilots must use an enclosed cockpit that meets the requirements listed in the Worker Protection Standard (WPS) for agricultural pesticides [40 CFR 170.240(d)96)J. Flaggers supporting aerial applications must use an enclosed cab that meets the definition in the WPS [40 CFR 170.240 (d)(S)] for dermal protection. In addition, flaggers must wear long-sleeved shirt, long pants, shoes, and socks.

USER SAFETY RECOMMENDATIONS Users should:

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

• Remove clothingiPPE immediately if pest'lcide gets inside. Then wash thoroughly and put on clean clothing.

• Remove PPE immediately after handling this product. Wash the outside of gloves before removing. As soon as possible, wash thorouqhly and chanQe into clean clothinQ.

ENVIRONMENTAL HAZARDS 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 contaminate water when disposing of eqUipment washwater or rinsate. This product may contaminate water through drift of spray in Wind. This product has a high potential for runoff for several months or more after application. Poorly draining soils and soils with shallOW water tables are more prone to produce runoff that contains this product. A level, well-maintained vegetative buffer strip between areas to which this product is applied and surface water features, such as ponds, streams, and springs, will reduce the potential for contamination of water from runoff. Runoff of this product will be reduced by avoiding applications when rainfall is forecast to occur within 48 hours. Sound erosion control practices will reduce this product's contribution to surface water contamination. This product has properties and characteristics associated with chemicals detected in ground water. Use of this chemical in areas where soils are permeable, particularly where the water table is shallow, may result in ground water contamination, GENERAL INFORMATION THIDIAZURON-DIURON 4.SSC is a harvest aid for cotton, used for leaf removal prior to harvest. THIDIAZURON-DIURON 4.5SC can be applied in most weather conditions, both warm and cool.

Filename: Thidiazuron-Diuron 4.5SC (364-021607) AD092107 RED + PR 2007-4 (Clean).doc Page 2

### !
RED 

### + PR Notice 2007-4

USE PRECAUTIONS This product is not to be applied through any type of irrigation system. Effectiveness of THIOIAZURON-DJURON 4.5SC 

### will be reduced if rainfall occurs within 12 hours post application. Foliage from treated plants or gin trash is not to be fed to livestock.

SPRAY DRIFT MANAGEMENT

a. Requirements for reducing spray drift for Diuron ground and aerial applications. 

### b. Use best practices to avoid drift to all other crops and non-target areas. Do not apply when conditions favor drift from target areas. The interaction of many equipment and weather-related factors determine the potential for spray drift. Avoiding spray drift at the application site is the responsibility of the applicator. The applicator must follow the most restrictive precautions to avoid drift, including those found in this labeling as well as applicable state and local regulations and ordinances. A drift control agent may reduce drift, however, it may also decease weed control.

c. Make aerial or ground applications only when the wind speed is less than or equal to 10 miles per hour. d. Do not make aerial or ground applications into temperature inversions.

e. Apply with medium or coarser spray (according to ASAE standard 572) for standard nozzles. f. Additional requirements for ground applications: When applying to crops, apply with nozzle height no more than 2 feet above the ground or crop canopy. g. Additional requirements for aerial applications: The spray boom should be mounted on the aircraft so as to minimize drift caused by wing tip vortices. The boom length must not exceed 7S% of the wingspan or 90% of rotor blade diameter. h. Use upwind swath displacement. i. Do not release spray at a height greater than 6 to 10 feet above the ground or crop canopy. 

### j. Do not apply by air if sensitive non-target crops are within 100 feet of the application site.

Rotation to the following crops requires the minimum specified periods below after the last application of THIDIAZURON-OIURON 4.SSC: small grains, sorghum, corn, or root crops (except carrots, onions)

................................. two (2) months legumes (including alfalfa) or leafy vegetable (except lettuce)

....................................... two (2) months cole crops, garlic, safflower, tomatoes, and watermelon

.... "

.......... "

............................. two (2) months carrots

........................................................................................................... three (3) months onions

........................................................................................................... four (4) months cantaloupe, honeydew melon/casaba melon, muskmelon, or peppers

......................... five (S) months lettuce

........................ when soil has been deep-plowed (12-15 inches)

...................... two (2) months

OR lettuce

.......... when soil is only disced (4-6 inches)

.................................... nine (9) months All other crops

.............................................................................................. twelve (12) months

Special Note for inter-cropped grains and legumes planted either as cover crops or planted into treated fields before the minimum two (2) month plant back time after the final THIDIAZURON-DIURON 4.SSC application: Any such crops are prohibited for use as feed or food and may be used only as cover crops.

Immature crops should not be used for food or feed.

Prevent spray drift from contacting crops other than mature cotton, since this product may defoliate or injure other plant species.

Mixtures with organophosphates can increase nontarget crop phytotoxicity. Additional care should be exercised when lettuce, citrus, cantaloupes or any other edible crops are adjacent to THIDIAZURONOIURON 4.SSC treated cotton fields.

PROCEDURES TO LOWER SPRAY DRIFT POTENTIAL ONTO NONTARGET CROPS Under windy weather conditions, applications of THIDIAZURON-DIURON 4.5SC may drift to non-target crops.

Filename: Thidiazuron-Diuron 4.5SC (364-021607) AD092107 RED + PR 20074 (CJean).doc Page 3RED 

### + PR Notice 2007-4

The following procedures can help reduce the potential for drift:

• If wind speeds top ten (10) miles per hour at the application site, do not make aerial or ground applications ofTHIOIAZURON-DIURON 4.5SC.

• Nozzle pressure of 20-30 psi is recommended.

• Do not apply this product during a temperature inversion because drjft potential is high. In addition, do not apply this product if the development of a temperature inversion appears likely during the application period.

• This product shOUld not be applied by ground within 100 feet or by air within 0.5 mile of lettuce.

RIO GRANDE VALLEY OF TEXAS PROCEDURES TO LOWER SPRAY DRIFT POTENTIAL The following procedures can help reduce the potential for drift:

• If wind speedS top ten (10) miles per hour at the application site, do not make aerial or ground applications of THIDIAZURON-DIURON 4.5SC. If wind speeds are less than ten (10) miles per hour, observe local recommendations from your State Extension Cotton Specialist.

• Nozzle pressure of 20-30 psi is recommended.

• Do not apply this product during a temperature inversion because drift potential is high. In addition, do not apply this product if the development of a temperature inversion appears likely during the application period.

• The maximum nozzle orifice size that provides proper coverage and deposition of this prOduct should be used.

• CITRUS AREAS: This product should not be applied by ground within 0.5 mile or by air within 5 miles upwind of citrus in flush.

• Do not apply by air within % mile of lettuce. Ground applications are restricted to 100 feet away from lettuce.

DIRECTIONS FOR USE It is a violation of Federal law to use this product in a manner inconsistent with 

### its labeling.

Do not make applications of this product that may contact workers or other person either by drift or directry. Protected handlers only are allowed in the area during application. Consult your State or Tribe agency responsible for pesticide regulations for any specific recommendation.

Filename: Thidiazuron-Diuron 4.SSC (354-021607) AD092107 RED + PR 2007-4 (Clean).doc Page 4RED 

### + PR Notice 2007-4

AGRICULTURAL USE REQUIREMENTS Use this product only in accordance with its labeling and with the Worker Protection Standard, 40 CFR Part 170. This Standard contains requirements for the protection of agricultural workers on farms, forests, nurseries, and greenhouses, and handlers of agricultural pesticides. 

### It contains requirements for training, decontamination, notification, and emergency assistance. It also contains specific instructions and exceptions pertaining to the statement on this label about personal protective equipment (PPE), and restricted-entry interval. The requirements in 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 24 hours.

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 soiJ or water, is:

• Coveralls

• Chemical-resistant gloves made of any waterproof material

• Shoes plus socks

• Protective eyewear Thidiazuron products can not be applied by air within 

### % mile of lettuce or 5 miles downwind of the point of application when citrus is in flush (burst of new growth, as in springtime) in the Rio Grande valley of Texas. Ground applications are restricted to 100 feet away from lettuce and % mile downwind from the pOint of application for citrus. (In general, a decrease in droplet size or increase in wind speed at the time of application will result in risk to non-target organisms. Altematively, if droplet size is coarser or wind speeds are lower, exposures due to drift would be reduced.

TIME OF APPliCATION THJDIAZURON-DIURON 4.5SC defoliant applications are to be made only on mature cotton plants when the uppermost harvestable boll is mature. Boll maturity is defined as 1) when a boll is squeezed between thumb and finger, it does not dent; 2) when cutting a cross section with a sharp knife is d'lfficult; 3) when seeds in cross section lack liquid within the seed coat or outer edges of seed coat are light brown; and 4) when fully developed cotyledons are present.

Make applications of THIDIAZURON-DIURON 4.5SC at least 5 days prior to expected harvest date.

NOTE: Adequate defoliation with THIDIAZURON-DIURON 4.5SC depends on three factors:

• Cotton is actively growing.

• High relative humidity.

• Cotton plant leaves are turgid and not desiccated.

ATTENTION: Desiccation and/or leaffreezing may occur during periods of high temperature when adjuvants are added to THIDIAZURON-DIURON 4.5SC application solution. Products and adjuvants known to cause desiccation of cotton leaf tissue should not be used.

Under low nighttime temperatures (below 60"F) or otherwise adverse condiflons, th'ls product, when used alone, may provide less than expected defoliation and / or regrowth suppression.

Likewise, cotton that does not have a uniform boll load, has excessive vegetaflve growth and/or is being defoliated with less than 65% open boll then a tank mixture of adjuvants and other defoliant materials should be considered.

TANK MIX OF Thidiazuron-Diuron 4.5 SC plus other cotton defoliant products: The tank mix Thidiazuron-Diuron 4.5SC plus other cotton defoliant products is recommended 

### to improve overall defoliation, and as an aid in accelerating the opening of mature, unopened cotton bolls. Best activity will be obtained where the tank mix is applied to mature cotton plants. Do not apply tank mix before sufficient unopened bolls have matured to produce the desired cotton yield.

For cotton produced in non-arid conditions, apply Thidiazuron-Diuron 4.5 SC at a rate of 3.2 to 6.4 fluid

ounces per acre plus other cotton defoliant products at a rate of 21 to 42 fluid ounces per acre.

Filename: Thidiazuron-Diuron4.5SC (364-021607) AD092107 RED + PR 2007-4 (Clean).doc 

### Page 5RED 

### + PR Notice 20074

For cotton produced in arid conditions, apply Thidiazuron-Diuron 4.5 SC at a rate of 6.4 to 16 fluid ounces per acre plus other cotton defoliant products at a rate of 21 to 42 fluid ounces per acre.

APPLICATION INFORMATION Use an adequate volume of water with the recommended amount of THIDIAZURON-DIURON 4.5SC defoliant to uniformly and completely cover leaves. For ground equipment, apply 10

- 25 gallon per acre and by air, use 2 -10 gallons per acre. Maintain agitation during application.

DOSAGE INFORMATION

In some situations, a follow-up application may be needed. THIDIAZURON-DIURON 4.5SC may be used for this application. Other defoliants may be needed. If additional boll opening is required, Ethephon 6 or any other boll-opening products may be used at recommended rates; see product label for rates and timings. Consult your local State Extension Cotion Specialist recommendations for rates and timings.

The maximum annual use rate of THIDIAZURON-DIURON 4.5SC is 5.33 fl. oz. formulation (0.33 pints) per acre per season.(0.187 ai/Acre combined Thidiazuron-Diuron) (.125 ai/Acre Thidiazuron and .062 ai/Acre Diuron) Maximum of 2 applications, but not to exceed 0.3 Ibs ai Thidiazuron per year. Maximum application rate of 0.3 Ibs ai/A Thidiazuron per year. Minimum retreatment interval of 21 days.

MIXING INSTRUCTIONS 1. Fill spray applicator tank with at least one half of the water to be used 2. Start agitation 3. Add the appropriate volume ofTHIDIAZURON -D1URON 4.5SC 4. Continue agitation and fill tank with the remainder of the water to be used 5. Agitation should continue throughout the application

PRECONDITIONING When used as a pre-conditioner seven to ten days before application of this or other defoliant compounds, this product will improve the efficacy of such a defoliant application. Before use, observe all product label directions, recommendations and prohibitions on both products' labels.

PRECONDITIONING APPLICATION RATE for THIDIAZURON DlURON 4 SSC



# - 

# . THIDIAZURON-DIURON 4.SSC One Gallon of Gallons ofS**~y** Solution Formulated Product THIDIAZURON-DIURON 4.SSC 

### Will Treat Air Ground 0.67 FI. Oz. 191 1.33 FI. Oz. 96 2-10 10-25 2.00 FI. Oz. 

### 48

STANDARD APPLICATION STANDARD APPLICATION RATE; Use 1.33-2 fI.oz. of this product/acre in an aerial application of 2-10 gallons of spray solution or ground application of 10-25 gallons of spray solution.

APPLICATION RATE TABLE for THIDIAZURON DIURON 4 SSC



# - . THIDIAZURON-DIURON 4.5SC One Gallon of Pounds Active Gallons of Spray Solution Formulated Product THIDIAZURON- Ingredients DIURON 4.5SC per Acre

Will Treat Air Ground 0.67 

### fl.**ozjAC;~** 

### iO.04 ot./Acre 191 Acres 0.0235 2-10 10-25
1.33 fl. oz.lAcre

Filename: Thidiazuron-Diuron 4.SSC (364-021607) AD092107 RED + PR 2007-4 (Oean).doc Page 6)



### RED 

### + PRNotice2007-4

0.08 pt.lAcre 

### 2.13 fl. 

### QzJAcre 60 Acres 

### 0.D75 (0.13 pt.lAcre)

### ~[93 fl

### OZjA~~ 0.18 pt./Acre 45 Acres 

### 0.10
4.27 fl. 

### Qz.lAcre 

### (0

.. 27 pt./Acrel 30 Acres 

### 0.15
5.33 fl. oz.lAcre 

### (0.33**pt.lAcr~)-** 24 Acres 

### 0.1875

RESTRICTIONS:



### • Do not apply more than 5.3 fluid ounces (0.33 pints) of Thidiazuron-Diuron 4.SSC per acre per season

.. 

### {O.iS7 ai/Acre (.125 ai/Acre Thidiazuron and .062 ai/Acre Diuron) Maximum of 2 applications, but not to exceed 0.3 Ibs ai Thidiazuron per year. Maximum application rate of 0.3 lbs 

### ai/A Thidiazuron per year.



### • Do not exceed maximum label rate with split applications of Thidiazuron-Diuron 4.5SC.

IMPORTANT CLEAN OUT INSTRUCTIONS 

### When applying THIDJAZURON-DIURON 4.5SC, a residue may form in application equipment. This residue can best be flushed out of the spraying system by using a commercial tank cleaner when done while residue is still fresh and moist. DO NOT ALLOW EQUIPMENT TO DRY BEFORE CLEANOUT. Consult your State Extension Cotton Specialist for recommended tank cleaners and cleaning procedures.

Tank cleaner and water should be used immediately after application. The entire system including nozzles, booms, application tanks, sumps, pumps, and transfer lines should be flushed. Allowing the spray solution to dry in the application equipment can result in residues that are more difficult to remove. Dried residues are extremely difficult to remove. To remove such dried residues, fill the affected equipment to capacity with commercial tank cleaner solution and let it remain for 7 days. Afterwards, the equipment 

### will need to be thoroughly flushed and rinsed.

Spray application equipment that has been inadequately cleaned will contain residue of THIDIAZURON

- DIURON 4.5SC. Such improper cleaning could lead to crop damage in later applications.

Arysta lifeScience North America, LlC assumes no liability due to equipment that has not been properly cleaned.

STORAGE AND DISPOSAL Do not contaminate water, food, or feed by storage or disposal. PESTICIDE STORAGE: Store this product in a cool, dry place in its original container only. Container should be closed when not in use. Do not expose the product to open flame excessive heat. Store in Original container and keep closed.

PESTICIDE DISPOSAL: Pesticide wastes are acutely hazardous. Improper disposal of excess pesticide, spray 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 Control Agency, or the Hazardous Waste representative at the nearest EPA Regional Office for guidance.

To Contain a Spill: Absorb liquid by covering it with cat litter, commercial clay, lime, sand, sawdust, or soda ash. Once absorbed, bury the cleaning materials and cleanse the spill area with a detergent and water solution.

CONTAINER DISPOSAL: Nonrefillable Containers equal to or less than 5 gallons: Nonrefillable container. Do not reuse or refill this container. Triple rinse container (or equivalent) promptly 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 X full with water and recap. Shake for 10 seconds. Pour rinsate

Filename: Thidiazuron·Diuron 4.SSC (364·021607) AD0921 07 RED + PR 2007-4 (Clean).doc Page 7RED 

### + PR Notice 2007-4

into application equipment or a mix tank or store rinsate for later use or disposal. Drain for 10 seconds after the flow begins to drip. Repeat th'IS procedure two more times. Nonrefillable Contarners Greater than 5 gallons: Triple rinse as follows: Empty the remaining contents into application equipment or a mix tank. Fill the container 

### X. fuJI 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. Stand the container on its end and tip it back and forth several times. Turn the container over onto its other end and tip it back and forth several times. Empty the rinsate into application equipment or a mix tank or store rinsate for later use or disposal. Repeat this procedure two
more times. 

### Offer for recycling, if available, or puncture and dispose of in sanitary landfill, or 

### by other procedures approved by State and local authorities. REFILLABLE CONTAINERS: Refill this container with pesticide only. Do not reuse this container for any other purpose. Cleaning the container before final disposal is the responsibility of the person disposing of the container. Cleaning before refilling is the responsibility of the refiller. To clean the container before final disposal, empty the remaining contents from this container into application equipment or 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 or rinsate collection system. Repeat this rinsing procedure two more times.

Warranty and Disclaimer Statement The directions for use of this product are believed to be adequate and must be followed carefully. However, it is impossible to eliminate all risks associated with the use of this product. Such risks may arise from weather conditions, soil factors, off-target movement, unconventional farming techniques, the presence of other materials, the manner of use or application, or other unknown factors, all of which are beyond the control of Arysta LifeScience North America, LLC ("Arysta"), and can cause crop injury, injury to non-target crops or plants, ineffectiveness of the product, or other unintended consequences. All such risks shall be assumed by the user or buyer. Arysta warrants that this product conforms to the chemical description on the label and is reasonably fit for the purposes stated in the Directions for Use, subject to the inherent risks described above, when used in accordance with the Directions for Use under normal conditions. This warranty does not extend to the use of this product contrary to label instructions or under conditions not reasonably foreseeable to Arysta, and is subject to the inherent risks described above.



### TO THE EXTENT CONSISTENT WITH APPLICABLE LAW, ARYSTA DISCLAIMS ALL OTHER WARRANTIES, EXPRESSED OR IMPLIED, INCLUDING ANY WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE. TO THE EXTENT CONSISTENT WITH APPLICABLE LAW, ARYSTA, MANUFACTURER, AND SELLER DISCLAIM AND SHALL NOT BE LIABLE FOR ANY SPECIAL, INCIDENTAL, INDIRECT, OR CONSEQUENTIAL DAMAGES RESULTING FROM THE USE, HANDLING, APPLICATION, STORAGE, OR DISPOSAL OF THIS PRODUCT OR FOR DAMAGES IN THE NATURE OF PENALTIES, AND THE USER AND BUYER WAIVE ANY RIGHT THAT THEY MAY HAVE TO SUCH DAMAGES. NO AGENT, REPRESENTATIVE OR EMPLOYEE OF ARYSTA IS AUTHORIZED TO MAKE ANY WARRANTY, GUARANTEE OR REPRESENTATION BEYOND THOSE CONTAINED HEREIN OR TO MODIFY THE WARRANTIES CONTAINED HEREIN.

TO THE EXTENT CONSISTENT WITH APPLICABLE LAW, THE EXCLUSIVE REMEDY OF THE USER OR BUYER, AND THE TOTAL LIABILITY OF ARYSTA, MANUFACTURER, AND SELLER, SHALL BE LIMITED TO THE PURCHASE PRICE PAID, OR AT ARYSTA'S ELECTION, THE REPLACEMENT OF THE PRODUCT.

Filename: Thidiazuron-Diuron 4.5SC (364-021607) AD092107 RED + PR 2007-4 (Clean).doc Page 8THIDIAZURON-DIURONSCCOTTONDEFOLIANTForAgriculturalUseOnlyACTIVEINGREDIENTS:Thidiazuron:N-phenyl-N'-I,2,3-thidiazol-5-ylurea*...........................36.06%Diuron:3-(3,4-dichlorophenyl)-I,I-dimethylurea*............................18.04%OtherIngfedients:...................................................................45.90%TOTAL.....................................................................100%Conlains3lb.ThidiazurOilpergallonand1.5lb.DiuronpergallonKEEPOUTOFREACHOFCHILDRENCAUTIONSiustednoentiendelaetiqueta,busqueaalguienparaqueselaexpliqueaustedendetalle.(Ifyoudonottmderstandthislabel,findsomeonetoexplainittoyouindetail.)FIRSTAIDIFSWALLOWEDImmediatelycallapoisoncontrolCenterordoctorfortreatmentadvice.Donotinducevomitingunlesstoldtodosobyapoisoncontrolcenterordoctor.Havepersonsipaglassorwaterifabletoswallow.DoanythingmouthtoanIFINEYES:Holdeyeopenandrinseslowlyandgentlywithwaterfor15-20minutes.Removecontactlenses,ifpresent,afterthefirst5minutes,thencontinuerinsing.CallapoisoncontrolcenterordoctorfortreatmentadviceNOTETOPHYSICIAN:ProbablemucosaldamagemaycontraindicatetheuseofgaslriclavageHOTLINENUMBERHavetheproductcontainerorlabelwithyouwhencallingapoisoncontrolcenterordoctororgoingfortreatment.EMERGENCYNUMBERS:FOR24-HOUREMERGENYMEDICALASSISTANCECALL:1-866-303·6952FORCHEMICALEMERGENCY:Spill, leak,fire,exposure,oraccidentcallCHEMTREC1-800-424-9300SEEATIACHEDBOOKLETFORADDITIONALPRECAUTiONSANDUSEDIRECfIONSFilenamc:Thidiazliron-DiulOn4.5SC(364-02(607)AD092107RED+PR2007-4(CICHlI).docRED+PRNotice2007-4PRECAUTIONARYSTATEMENTSHAZARDSTOHUMANSANDDOMESTICANIMALSCAUTIONHarmfulifswaUowed.Causesmoderaieeyeirritalion.Avoidconlaclwilheyesorclolhing.Washthoroughlywilhsoapandwaterafterhandlingandbeforeeating,drinking,chewinggum,orusinglobacco..ENVIRONMENTALHAZARDSDonotapplydireclly10waler,ortoareaswheresurfacewaterispresenlortoinlertidalareasbelowthemeanhighwalermarieDonorcontaminatewalerwhendisposingofequlpmenlwashwalerorrinsale.Thisproductmayconlaminatewalerthroughdriftofsprayinwind.ThisproducthasahighpotentialforrunoffforseveralmonthsormoreafterappHcation.Poorlydrainingsoilsandsobwithshallowwatertablesaremoreprone10producerunOffthatcontainsthisproductAlevel,well-mainlainedvegetativebufferstripbetweenareastowhichthisproductisappliedandsurfacewaterfeatures,suchasponds,streams,andsprings,willreducethepolentialforcontaminationofwaterfromrunoff.Runoffofthisproductwillbereducedbyavoidingappficationswhenrainfallisforecasttooccurwithin48hours.Sounderosioncontrolpracticeswillreducethisproducl'scontribuliontosurfacewaterconlamination.Thisproducthaspropertiesandcharacteristicsassociatedwllhchemicalsdelectedingroundwaler.Useofthischemicalinareaswheresoilsarepermeable,particularlywherethewalertableisshallow,mayresultingroundwalerconlaminalion.DIRECTIONSFORUSEItisaviolalionofFederallawtouseIhisproductillamannerinconsistcntwithitslabeling.Donormakeapplicationsofthisproductthatmayconlaclworkersorolilerpersoneilherbydriftordireclly.ProtectedhandlersonlyareallowedinIheareaduringapplication.ConsultyourStateorTribeagencyresponsibleforpcslicideregulalionsforanyspecificrecommendation.STORAGEANDDISPOSALDonotcontaminalewaler,food,orfeedbyslorageordisposal.PESTICIDESTORAGE:Storethisproductinacool,dryplaceinilsoriginalcontaineronly.Containershouldbeclosedwhennotinuse.Donolexposetheproduct10openflameexcessiveheal.Sioreinoriginalcontainerandkeepclosed.PESTICIDEDISPOSALPeslicidewaslesareaculelyhazardous.Improperdisposalofexcesspesticide,spraymixlure,orrinsateisaviolationofFederallaw.IfIllesewastescannolbedisposedofbyuseaccordingtolabelinslruclions,coniactyourStatePesticideorEnviromnenlalConlrolAgency,ortheHazardousWasterepresentaliveatIheneareslEPARegionalOfficeforguidance.ToConlainaSpill:Absorbliquidbycoveringitwilhcatlitter,commercialclay,lime,sand,sawdust,orsodaash.Onceabsorbed,buryIhecleaningmaterialsandcleansethespillareawilhadclergenlandwatersolulion.CONTAINERDISPOSAL:NonrefillableContainersequaltoorlessthan5gallons:Nonrefillablecontainer.Donotreuseorrefillthiscontainer.Triplerinseconlalner(orequivalenQpromptlyafteremplying.Triplerinseasfollows:EmptyIheremainingconlenlsintoapplicallonequipmentoramixtankanddrainfor10secondsaftertheflowbeginstodrip.Flilihecontalner:v.fullwilllPage9waterandrecap.Shakefor10seconds.Pourrinsateintoapplicationequipmentoramixtankorstorerinsateforlateruseordisposal.Drainfor10secondsaftertheflowbeginstodrip.Repeatthisproceduretwomoretimes.NonrefillableContainersGreaterthan5gallons:TriplerinseasfolloWS:Emptytheremainingcontentsintoapplicationequipmentoramixtank.FillthecontainerY.fullwllhwater.ReplaceandtightenClosures.Tipcontaineronlissideandrollitbackandforth.ensuringatleastonecompleterevolution,for30seconds.Standthecontaineronitsendandtipitbad<andforthseverallimes.Turnthecontaineroverontoitsotherendandtipitbackandforthseveraltimes.Emptytherinsateintoapplicationequipmentoramixtankorstorerinsateforlateruseordisposal.Repeatthisproceduretwomoretimes.Offerforrecycling,ifavaffable,orpunctureanddisposeofinsanitarylandfill,orbyotherproceduresapprovedbyStateandlocalauthorifies.REFILLABLECONTAINERS:Refillthiscontainerwithpesticideonly.Donotreusethiscontainerforanyotherpurpose.CleeningthecontainerbeforefinaldisposalIstheresponsibilityofthepersondisposingofthecontainer.CleaningbeforerefillingIstheresponsibilityoftherefiller.Tocleanthecontainerbeforefinaldisposal,emptytheremainingcontentsfromthiscontainerIntoapplicationequipmentormixtank.Fillthecontainerabout10percentfullwithwater.Agilatevigorouslyorrecirculatewaterwiththepumpfor2minutes.Pourorpumprinsateintoapplicationequipmentorrinsatecollectionsy.slem.RepeatthisrinSingproceduretwomoretimes.EPAReg.No.66330-364EPAEst.No.51036-GA-OOIAD092107NETCONTENTS,___Manufacturedfor:Al)'staLifeScienceNorthAmerrca,LLC15401WestonParkway,SuiteISOCal)',NC27513Filename:Thidiazurou-Diuroll4.SSC(364-02t607)AD092107RED+PR2007-4(Clean).doeRED+PRNotice2007-4Page10

### Secondary Review of 66330-364

For clarity 

### in Comment #6 the revised application rate required by the RED should be specified. According to my calculations, 5.3 fl. oz. is the maximum application rate for this product.

### Date: September 21, 2009

Reg. No.: 066330-364 

### Product Name: Thidiazuron-Diuron 4.5 SC PM NameINumber: Joanne Miller, PM 23 

## .0urh

# ~J-c.! 1'/1')/

# O~ Primary Reviewer: 

### Judy Loranger 

## >-':;.:0......-7 ., ...::.......

. Secondary Reviewer: 

## Larry Scbnaubelt 

# L**g~** 

# //;/",,;0:;

New label or date ofRD amended label: New, Received on **1/12/09**



### Formulation Type: Emulsifiable Concentrate

Active Ingredient Assessed: Thidiazuronl230301



### Other ai's in 

### product NamelPC code: Diuronl035505

Note to 

### PM: 

### Reregistration Status or Registration Date: Registered after Diuron RED was issued.

1) Risk Management and Implementation Bnmch 5 (RMIB5) notes that the label for this 

## product does not include resistance management labeling as described in 

## PR Notice 2001-5. The Agency encourages registrants to add the resistance management grouping 

## symbols and statements to product labels in view of the importance of resistance management to a long-term pest management strategy.

2) RMIB5 notes that the rate restriction text on Page 38 of the RED label table that 

### specifies fluid ounces of product per area to be treated may be a problem if, based on the concentration of the product, the amount of the active ingredient exceeds the allowable rate on Page 37 

### of the 

### label table. Refer to item 5 

### below for an example of this 

### issue.

Assessment can be found N:\prb\label\066330/364

1) 

### Per the acute toxicity review, the signal word currently on Page 1 

### of the 

### label "DANGER" 

### must be revised to read "CAUTION."



### 2) 

### Per the acute toxicity review, the Hazards to Humans and Domestic Animals statements on Pages 2 

### and 9 

### of the label must be revised to reacl:

"CAUTION 

### Harmful if swallowed."

2) Per the Diuron and Thidiazuron REDs, the handler PPE section must be revised to 

### read:



## 1

### "Some materials that are chemical-resistant to this product are made of barrier laminate

or butyl rubber. 

### If you want more options, follow the instructions for category [XXXX]

on an EPA chemical-resistance category selection chart.

All pilots, flaggers and groundboom applicators must wear: Long-sleeved shirt and long pants, and Shoes plus socks.

All mixers, loaders, other applicators, and other handlers must wear: Long-sleeved shirt and long pants, Shoes plus socks, Chemical-resistant gloves, A NIOSH-approved dust/mist filtering respirator with any N, R, P or HE filter or an NIOSH-approved dust/mist filtering respirator with approval number prefix TC-21C, Chemical-resistant apron when mixing, loading, or cleaning equipment or spills.

See engineering controls for additional requirements."

Note: The appropriate chemical-resistant category must be added to the first paragraph of this section of the label.

3) To differentiate from the User Safety Recommendations, the User Safety Requirements should not be enclosed in a box.

4) Per the Diuron RED, the General Application and Restriction text "Protected handlers only are allowed in the area during application" currently on the label must be revised to read "Only protected handlers may be'in the area during application."

5) The text "for cotton produced in arid condition, apply Thidiazuron-Diuron at a rate of 6.4 to 16 fluid ounces (.37Ibs 

### ai thidiazuron) per acre plus other cotton defoliant products
at a rate of 21 to 

### 42 fluid ounces per acre" must be revised because the rate of up to 16 fluid ounces exceeds the maximum allowable application rates as specified on Page 31 of the 

## RED.

The rate restriction text on the label must be revised to read as specified below and any conflicting text must be deleted:

''Under normal conditions: The maximum application rate is O.1251bs 

### ai thidiazuron per acre. The maximum annual application rate is .3 lbs 

### ai thidiazuron per acre per year.

During periods of rank growthlhigh fertilizer conditions, extended periods of rain or low temperatures, and on full season cotton varieties: The maximum application rate is .2 lbs ai thidiazuron per acre. The maximum annual application rate is 0.3 lbs ai thidiazuron per acre per year."



### 2)



### 6) Per the Diuron RED, a 21-day minimum retreatment interval must be added to the 

### label.

7) On page 3 of the label, under SPRAY DRIFT MANAGEMENT, for item ')", add the qualifying phrase"

... except as noted for lettuce and citrus" since without qualification the text would conflict with the lettuce and citrus restrictions. The RED also requires the additional text:

"(In 

### general, a decrease in 

### droplet size or increase in 

### wind speed at the time of application will 

### result 

## in risk to non-target organisms. Alternatively, if 

### droplet size is

coarser or wind speeds are lower, exposures due to drift would be reduced)."



## Note: The rotational crop and plant back sections should be moved from the SPRAY DRIFT MANAGEMENT section to the DIRECTIONS FOR USE section.

8) On page4 of the label, in 

### the last bullet of the frrst paragraph and the second to last 

### bullet of the second paragraph, revise the phrase ''This product should not be applied

.. . " to "Do not apply this product.

.. ".



### 3

### DATE OUT: 

### ll/AUG/09

SUBJECT: PRODUCT CHEMISTRY REVIEW OF: TGAI []; 

### MUP []; EUP [x] 

### BARCODE NO.: 362002 REG./FILE SYMBOL NO.: 66330·364 PRODUCT NAME: Thidiazuron-Diuron 4.5SC MRID 

### NOS.: 470706-01.470765-01.476411-01 

### COMPANY NAME: Arysta LifeScience North America LLC ACTION CODE: 674

FROM: Shirley H. Keel, Environmental Protection Specialist Product Chemistry Team [sign. S. Keel, 

### 8/11/09J PRBISRRD 

### (7508P)

TO: Barbara Briscoe, CRM Product Reregistration Branch 

### Special Review and Reregistration Division (7508P)

INTRODUCTION:

A Reregistration Eligibility Decision (RED), Case number 4092, was issued 

### in September, 2005 for the Active' Ingredient 

### (Al) Thidiazuron [1-phenyI-3-(1,2,3-thidiazol-S-yl)ureaJ. According to the RED, the generic data base supporting the reregistration ofThidiazuron for its current uses has been reviewed and found to 

### be substantially complete.



### In the 8-month response to the Thidiazuron RED, in support of the reregistration ofThidiazuron-Diuron 4.5SC, EPA Reg. No. 66330-364, the registrant submitted a Confidential Statement of Formula (CSF), a basic formulation, dated 

### 12/20/08; a draft label received by EPA on 1112109; and product chemistry data in 

### MRID numbers 470706-01, 470765-01 and 476411-01.

FINDINGS:

1. EPA Reg. No. 66330-364 is an end-use product containing the active ingredients-Thidiazuron and Diuron-at label 

### claim nominal concentrations of36.06% and 18.04% respectively.

2. The 

### CSF for the basic fonnulation, dated 

### 12/20/08, is acceptable with one comment: The purity of the source material Diuron 

### " The nominal concentrations of the active ingredients agree with those on the label, meeting the requirements ofPR Notice 

### 91-2. The certified limits for the active and inert ingredients are acceptable 

### as per 40 CFR §158.175(b)(2). All ingredients listed in the CSF are cleared for use in pesticide formulations.

Note to PM:

There is one typographical error in the record with EPA Reg. No. 66330-364 in OPPIN database. 

### In the Window of Product Registration, the correct Product Name is Thidiazuron-Diuron 4.5SC, not "Thidiazuron-Diuron 4.55C."

3. The product chemistry data reported 

### in 

### MRID Nos. 470706-01. 470765-01 and 476411-01 satisfy the requirements of Guidelines under Subgroups A and B, which pertain to Product Identity, Composition and Analysis, and Physical and Chemical Properties respectively.



### 1

### 4. The product chemistry statements of the draft label are acceptable. The Ingredient statement is in compliance with the requirements of 40 CFR 156.10(g) and PR Notice 91-2. There are no physical/chemical hazards present in the product that will trigger the Physical or Chemical Hazards subheading.

5. The Storage and Disposal statements of the draft label are acceptable in accordance with 40 CFR 156.10 and PR Notice 83·3.

Note to PM: It appears that the registrant has modified the Storage and Disposal statements to comply with 

### PR Notice 2007-4 (Pesticide Management and Disposal; Standards for Pesticide Containers and Containment). PRBISRRD defers the ace:eptability of these statements to the Registration Division.

CONCLUSIONS:

The registrant has satisfied product chemistry data requirements for the reregistration of EPA Reg. No. 66330-364.



### 2

### Product Chemistry Data Subgroup A: Guidelines Series 830.1550

- 830.1800 (40 CFR §158.320 -158.355) 

### Product Identity, Composition, and Analysis

Guideline Reference No. (GRN)/ Title 830 40CFR§ 

### MRIDNumber Data Fulfilled

830.1550 Product Identity and Composition 158.320 470706-01& CSF Y



### 830.1600 Description of Materials 

### Used to 158.325 

### Produce the Product 470706-01f MSDS ) &C F Y



### 830.1650 Description of Formulation 

### Process 158.335 470706-01 Y



### 830.1670 Discussion of Formation of 158.340 470706-01 Y 

### Impurities

830.1750 Certified Limits 158.350 470706-01& CSF Y



### 830.1800 Enforcement Analytical Method 158.355 470706-01 Y



## . Subgroup B: Senes 830.6302

- 7950 (40 CFR §158.310) Pb· d C . 1P

.



### hysical an hemlca roperttes
Guideline Reference Value OR Qualitative Description MRIDNO. 

### Data Fulfilled No. (GRN) / Title 830



### .6302 Color Off-white @ 25°C 470765-01 Y



### .6303 Physical State Liquid @ 25°C 470765-01 Y



### .6304 Odor Faint odor@ 25°C 470765-01 Y



### .6314 

### No apparent reaction when mixed with 470765-01 Y 

### OxidationlReduction: water, iron powder and monoammonium Chemical Incompatibility phosphate. Reaction observed with heat generated when mixed with potassium permanganate.

.6315 

### Flash point> 93°C 470765-01 Y 

### Flammability!Flame Extension

.6316 Explodability The product does not contain any known 470765-01 NlA 

### explosive components.



### 3

### .6317 Storage Stability of Samples were stored for one year, from 476411-01 Y Product 

### 6/9106 to 6/21107, under warehouse conditions 

### in packages of simulated commercial packaging material. The
amounts of Thidiazuron and Diuron were determined at the beginning of the test period, and after 3, 6, 9 and 12 months of storage. Results showed that there were no evidence of physical changes.

Months 

### Thidiazuron (%). 

### Diuron 

### (%)

0 

### 36.0 19.0



### 3 36.4 19.0

6 

### 36.4 19.0

9 

### 36.6 18.9

12 

### 36.2 19.2

.6319 Miscibility The product is an emulsifiable concentrate, 470765-01 N/A
not to be diluted with nonpolar solvent.

.6320 Corrosion No apparent corrosion of the packaging 476411-01 Y Characteristics material was observed.

.6321 Dielectric Not to be used around electrical equipment 470765-01 NlA Breakdown Voltage

.7000 pH 7.59 @250C 470765-01 Y

.7100 Viscosity 1.333 mPa s@250C 470765-01 Y

.7300 nensitylRelative 1.1538 glml@250C 470765-01 Y Densityl Bulk Density ExplanaTIons; Y - ReqUirement fulfiUed; N - ReqUirement not fulfilled; 

### N/A

- Not apphcable; G = 

### Data gap; U = 

### Upgraclable; I = 

### mcomplete or 

### in progress; W = 

### Waived.

830-1800 Enforcement Analytical Method

The amounts of the active ingredients- Thidiazuron and Diuron-in this product were determined by reverse phase 

### High Performance Liquid Chromatography (MRID No. 470706-01). The HPLC operating conditions

are set as follows: Column: Luna C-18, 51lm or equivalent, 15 cm x 4.6 rom Ld.; Column temperature: ambient; Mobile phase: Acetonitrile/HPLC water: 68/32; Flow rate: 1 mVmm; Detection wavelength: 220
nrn; Injection volume: 5 Ill; Run time: 25 min. Formulas for sample calculations are included,



### 4

### I



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

June 30, 2009

MEMORANDUM:

Subject:



### From:

To:

Applicant: EPA Reg. No.: 66330-364fThidiazuron-Diuron 4.5SC DP Barcode: 366687 Case No.:



### Jolene Trujillo, Biologist 

### Product Reregistration Branch Special Review and Reregistration Division (7508C)



## Barbara Briscoe, CRlvl Product Reregistration Branch Special Review and Reregistration Division (7508C)

Arysta LifeScience North America, LLC. 15401 Weston Parkway, Suite 150 Cary, NC 27513

FORMULATION FROM EPA Reg. No. 66330-364 LABEL:

Active Ingtedient(s): OFFlCEOF PREVENTION, PESTICIDES AND TOXIC SUBSTANCES



### % bywt.



### Thidiazuron

........................................................................................................... . 36.06% 18.04% 45.90% 100.00"10 

### DillIOn

..................................................................................... . Inert IngredientCsl:

............................................................................................... .. Total

### BACKGROUND: 

## In the 8 month response to the Thidiazuron RED, the registrant has submitted acute toxicity studies to support the reregistration of their 

### product, EPA Reg. No. 66330-364. 

### The MRID's are as follows: 470706-03 (81-1),470706-04 (81-2), 470706-05 (81-3), 470706-06 (81- 4),470706-07 (81-5), 470706-08 (81-6). The studies were conducted by Product Safety Labs. 

### The test material used in 

### each of 

### the 

### studies was the subject product. These studies were reviewed and five (81-2, 81-3, 81-4, 81-5, 81-6) were found to be acceptable by TRBIRD on 8/21/07. After 

### reviewing the studies, PRB concurs with TRB's findings on these five studies. The acute oral study (81-1) was determined to be unacceptable by TRBIRD on 8/21/07.

On June 30, 2009, 

### MRID 477839-01 (81-1) was submitted by the registrant as a completion of the 

### acute toxicity requirement.



### RECOMMENDATIONS:

• The acute toxicity study (81-1) 

### submitted is acceptable to support the reregistration of EPA Reg. No. 66330-364.

The acute toxicity profile for EPA Reg. No. 66330-364 is currently:

Acute Oral 

### Acute Dermal Acute Inhalation Primary Eye Primary Dermal 

### Skin Sensitization III 

## N N N 

### N



### non sensitizer Acceptable (LDso> 1750 mglkg) 

### Cited (LDso>5000 mglkg) 

### Cited (LC 

### so >2.03 mgIL) Cited 

### Cited Cited



### NOTE: The acute-toxicity requirements have been satisfied for the subject pro¢luct.

LABELING:

ID#: 66330-364 Thidiazuron-Diuron 4.5SC

SIGNAL WORD: CAUTION



### HAZARDS TO HUMANS AND DOMESTIC ANIMALS:

Harmful if 

### swallowed. 

### Wear long sleeved shirt and long pants, socks, and**shoes~**


### FIRST AID:

IF SWALLOWED: Call a poison control center or doctor immediately for treatment advise. Have person sip E!- 

### glass of water if able 

### to 

### sallow. Do not induce vomiting unless told to 

### by a poison

### control center or doctor. Do not give anything by mouth to an unconscious person.

Have product container or label 

### with you when calling a poison control center or doctor or going
·to treatment. You may also contact 1-800-xxx-xxxx for emergency medical treatment information.



### USER SAFETY RECOMMENDATIONS:

User should wash hands before eating, 

### drinking, chewing 

### gum, using tobacco, or using the toilet.

User should remove clothingIPPE immediately ifpesticide 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.

### DATA REVIEW FOR ACUTE ORAL TOXICITY (§81-1, 870.1100)

Reviewer: Jolene Trujillo Product Manager: Joanne Miller / 23 

## MRID No.: 477839-01 Study Completion Date: 06118/09 

### Report No.: 27522

Testing Facility: Product Safety Labs Author: S. Daua Oley

Quality Assurance (40 CFR §160.12):Inc1uded

Test Material: Tbidiazuron-Diuron 4.5SC, off-white liquid

Species: Sprague-Dawley derived albino rat



### Conclusion: Up & 

### Down Method

1. LDso(mglkg): 

## > 1750 mg/kg

2. Toxicity Category: III 

### Classification: Acceptable

Procedure (Deviations from §81-1): none

Results:



### Main Study (U&D)



### Test Sequence Animal 

### Id 

## Dose Level Short term (mg/kg) 

## outcome I 

### 3102 175 S 2 3103 550 S 3 3104 1750 S 4 3105 5000 D 5 3106 1750 D 6 3107 550 S 7 3108

. 1750 S 8 3109 5000 D 9 3110 1750 S 10 3111 5000 D



## . S

- SurvIval; 

## D - death Long term 

## outcome S S S D D S S D S D

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

OFFICE OF PREVENTION, PESTICIDES AND TOXIC SUBSTANCES



### February 17, 2009

MEMORANDUM:

Subject:

From:



### To:

Applicant: EPA Reg. No.: 66330-364!Thidiazuron-Diuron 4.55C 

## DP Barcode: 361484

. 

# , Case No.: 4092 .' / .



# .**'~\1** Marianne Lewis, Biologist j i / .' • 

## Product Reregistration Branch 

# r \;**~ ~**  Special Review and Reregistration Division (7508C)

Barbara Briscoe, CRM Prodnct Reregistration Branch Special Review and Reregistration Division (7508C)

Arysta LifeScience North America, LLC 15401 Weston Parkway, Suite 150 Cary, NC 27513

FORMULATION FROM EPA Reg. No. 66330-364 LABEL:

Active Ingredient(s): 

## Thidiaiuron

.......................................................................................................... . Diuron

..................................................................................... . Inert Ingredient(s):

................................................................................................ . Total % 

## bywt.

36.06% 18.04% 45.90% 100.00%

### )



### BACKGROUND: In 

### the 8 month response!o the Thidiazuron RED, the registrant is citing acute toxicity studies to support the reregistration of their product, EPA Reg. No. 66330-364. The MRID's are as follows: 470706-03 (81-1),470706-04 (81-2), 470706-05 (81-3),470706-06 (81- 4),470706-07 (81-5), 470706-08 (81-6). The studies were conducted by Product Safety Labs. 

## The test material used in each of the 

## studies was the subject product. These studies were reviewed and five (81-2, 81-3, 81-4, 81-5, 81-6) were found to be acceptable byTRBIRD on 

### 8/21/07. After 

## reviewing the studies, PRB concurs 

## with TRB's findings on these five studies. The acute oral study (81-1) was determined 

## to be unacceptable by 

## TRBIRD on 

### 8/21107.

From the TRB 

### 8/21/07 DER: "The acute oral toxicity study is classified as unacceptable. TRB discussed this study on August 7, 2007 with the Study Director, George Moore. TRB detected that an error was made by the laboratory when the results 

### of the eighth dose of the Main Study



## were recorded. The result of this 

## error was that the stopping criteria of the 

## UDP test were not met and therefore, an LD50 value was not determined. During this phone call options for salvaging 

## the study were discussed with 

## G. Moore. TRB gave the option to 

## the laboratory to plot the resul1$ using the Probit method 

## with the existing animals and to email 

## the results 

## to TRB. Again on

. August 14, the study director was contacted and a 

## voice mail message was left. To date, TRB has not yet received an answer." There is nothing 

## in the files indicating 

## that the lab or the registrant'

ever contacted TRB to resolve this matter. This study remains classified as unacceptable. A new study should be cited or submitted.

RECOMMENDATIONS:

• Five (81-2, 81-3, 81-4,81-5,81-6) of he acute toxicity studies cited are acceptable to support the reregistration of EPA Reg. No. 66330-364.

• The acute oral study (81-1) submitted is unacceptable. A neW study should be cited or 

## submitted.

The acute toxicity profile for EPA Reg. No. 66330·364 is currently:

Acute Oral Acute Dermal 

## Acute Inhalation PJ:jmaryEye Primary 

### Dermal 

## Skin Sensitization N N N N



## non sensitizer Unacceptable Cited 

### (ill" > 

### 5000 mglkg) Cited (LC" 

## > 2.03 mgIL) Cited Cited Cited

NOTE: The labeling will be completed upon receipt of the required infonnation. ,**,>~** •

. ",-,"-

### UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

CERTIFIED MAIL

Mr. Bill Washburn 

### Arysta LifeScience 15401 Weston Parkway, Suite 150 CiIlY. NC 27513 

# JUL 22 2009

SUBJECT: Thidiazuron Reregistration Eligibility Decision (RED), Review of Acute 

### Toxicity Data, EPA Registration Number**66330~364**



### Dear Mr. Washburn:

Your request 

### to cite acute toxicity 

### data required in response to the Thidiazuron Product Specific Data CallMIn Notice has been reviewed. You cited studies conducted on your product, EPA Registration Number 66330 M 

### 364 which were previously reviewed and 

### with exception to acute oral 

### 81Ml were determined to be acceptable. The acute oral study, MRID 47783901 

### was submitted June 3D, 2009 and determined to be acceptable.



### The acute toxicity profile for EPA Registration No. 66330

M 

### 364 is currently:

Guideline 

### Study Toxicity Category Classification

81-1 Acute Oral III 

### Acceptable 81-2 Acute Dermal 

### IV Acceptable 81-3 Acute Inhalation 

### IV Acceptable 81-4 Primary Eye 

### IV Acceptable 81-5 Primary Dennal 

### IV Acceptable 81-6 Skin Sensitization non sensitizer Acceptable

A detailed copy of the Data Evaluation Record is enclosed. If you have any questions, you may contact Barbara Briscoe at**703~308~8177.** 

### Sincerely,

Patricia L. 

### Moe, Chief Product Reregistration Branch Special Review and Reregistration Division--JlHOll\wiliJlll-Ulu!L!lrJI.\.SSc..,Page1014UnitedStatesEnvironmentalProtection10MBApproval2070-0107AgencyWashington,D.C.20460OMBApprovai2070·Q057REQUIREMENTSSTATUSANDREGISTRANT'SRESPONSE:PleasetypeorprintinInk.Pleasereadcarefullytheattachedinstructionsandsupplytheinformationrequestedonthisfonn.addillonalsheet(s)ifnecessary.f.CompanyNameandAddress12.Case#andName3.DaleiIhdTypeOfDCIandNumberARYSTALlFESCIENCENORTHAMERICACORPOR}4092Thidiazuron15401WESTONPARKWAY,SUITE150CARY,NC27513'ulrementl'<l.miber10.knowinglyamTitlef2.01Company5.StudyTilleEPAReg.No.66330-364ProgressReportsLLC.6.UsePattern08-May-2008PRODUCTSPECIFIClD#PDCI-120301-260857.TestSubstance8.TimeFrame(Monlhs)BIB/OS'.RegistrantResponsef3.Pho",N'mberqOi'432'5II&UnitedStatesEnvironmentalProtectionAgencyWashington,D.C.20460REQUIREMENTSSTATUSANDREGISTRANT'SRESPONSEorprint!nnecessary.1.CompanyNameandAddressARYSTALlFESCIENCENORTHAMERICACORPORI15401WESTONPARKWAY,SUITE150CARY,NC275134.GuidelineRequirementNumber830.63165.StudyTitleIn!!lal10indicatecertitlcatlonas10informaUonon1hispage(ful!textofcertiflcaUonIsonpageone).andsupply2.Case#andName4092ThidiazuronEPAReg.No.66330-364ProgressReports213requestedon6.UsePatternf6vPage2of4OMBApprovat2070-0W7OMBApprovat2070-00573.DateandTypeatDCIandNumber/.OS-May-20OBPRODUCTSPECIFIC10#PDCI-120301-260S57.TestSubstanceDate8(8(08B.TImeFrame(Months)IpG'",UnitedStatesEnvironmentalProtectionAgencyWashington,D,C.20460REQUIREMENTSSTATUSANDREGISTRANT'SRESPONSEPage3014OMBApprovat2070·0t07OMBApprovat207Q.0057typeorprintinink.Pleasereadcarefullytheattachedinstructionsandsupplytheinformationrequesfedonthis form.1.CompanyNameandAddressARYSTALlFESCIENCENORTHAMERICACORPORI15401WESTONPARKWAY,SUITE150CARY,NC275135.StudyTitleIndicatecertillcationasfoinformationonthispagetextofcertification1$onpageone).2.case#andName4092ThidiazuronEPAReg.No.66330-364(31,32),>"(44)ProgressReports2 I 36.UsePattern3.DateandTypeofDCIandNumberOB-May-200BPRODUCTSPECIFICID#PDCI-120301-260857.TestSubstanceDatet'J8!DB8.TimeFrame(Months)9.ResponseUnitedStatesEnvironmentalProtectionAgencyWashington,D.C.20460REQUIREMENTSSTATUSANDREGISTRANT'SRESPONSEINSTRUCTIONS:Pleasetypeorprintinink.Pleasereadcarefullytheattachedinstructionsandsupplytheintormationrequestedonthisform.Useadditionalsheet(s)ifnecessary.Page4of4OMBApprovat2070-Ot07OMBApproval2070-0057t.CompanyNameandAddress2.Case#andName3.DateandTypeofDCIandNumberARYSTALlFESCIENCENORTHAMERICACORPOR}15401WESTONPARKWAY,SUITE150CARY,NC275135.StudyTitleInitialtoIndicatecertificationastoInformationonthispage(fulltextofcertificationisonpaQeone).4092Thidiazuron(38,39)ProgressReports6.UsePattem08-May-2008PRODUCTSPECIFICIDItPDCI-120301-260857.TestSubstance0:.01Date8(B/088.TImeFrame(Months)

# PRODUCT REREGISTRATION

SUPPORTING DOCUMENTATION

FORM

Case Name:

__ 

# 1lu......-'-J._/....:..'1_Z_IJ_l'fJ_/f.!..-

__ _ Registration No. 

# Md30-36Z:

This supporting documentation (in chronological order) includes:



## o Old labels (identified as "Superceded by label dated xxlxxIxx)



## o Unacceptable CSF (marked "Not acceptable" and dated)

o Product chemistry reviews

o Acute toxicity reviews

o Efficacy and or special studies (if necessary)

f'l 

## 90-Day responses to PDCI (forms A and B)

" Administrative forms (Application for Reregistration Certification to Data citation, Data Matrix)**.~** 

## Correspondence (Company and Agency letters & 

## e-mails)UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D.C. 20460



### June 23, 2009

ARYSTA LIFESCIENCE NORTH AMERICA, LLC 15401 WESTONPARKWAY,SUlTE 150 CARY, NC 27513-

Report of Analysis for Compliance with PR Notice 86-5 OFFICE OF PREVENTION, PESTICIDES AND TOXIC SUBSTANCES



### Thank. you for your submittal of19-JUN-09. Our staff has completed a preliminary analysis of the material. The results are provided as follows:

Your submittal 

## was found to be in full compliance 

### 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. Please use these numbers in all future references to these documents. Thank you for your cooperation. If you have any questions concerning this data submission, please raise them 

### with the cognizant Product Manager, to whom the data have been released.

# ~ Arysta LifeScience

VIA FEDEX DELIVERY (Tracking No. 7967 0543 8755)



### Ms. Barbara L. 

### Briscoe, Chemical Review Manager Product Reregistration Branch Special Review and Reregistration Branch 7S08P Office of Pesticide Programs U.S. Environmental Protection Agency Room 54900, 

### One Potomac Yard 2777 South Crystal Drive Arlington, VA 22202

Dear Ms. Briscoe:
Subject: Thidiazuron-Diuron 4.5 SC 

### EPA Reg. No. 66330-364
Response to Agency Letter Dated April 13, 2009



### Please find enclosed the following documents in support of the subject product.

1. EPA Form 8570-1 

### (Application for Registration Amendment) 477839.00



### June 

### 18, 2009

One copy of EPA Form 8570-1 (Application for Registration Amendment) dated June 17, 2009. 

### This is not a PRIA action.

2. Bibliography of Submitted Studies



### One copy of the Bibliography of Submitted Studies (transmittal document) describing the submitted data in support of this registration application is 

### endosed.

3. study Reports

Three bound and labeled copies of each study described in the 8i.bliography of Submitted studies
are enclosed.

Please call on me at the e-mail address or telephone number shown below if you require any additional information or assistance in this matter. Thank you for your time and assistance in the registratic;m of this product

Arysta UfeScience North America, Il.C 

### Very truly yours,

Bill Washburn Regulatory Manager

Phone: (901) 432-5118 

### E-Mail: bill.washbum@arystalifescience.com

15401 Weston Parkway, Suite 150, Cary, NC 27513 Phone 919-678-4900 Fax 919-678-2194 www.arystalifesclence.comArystaLifeScienceNorthAmerica,LLC15401WestonParkway,Suite150Cary,NorthCarolina27513ProductName:EPARegistrationNumber:PurposeofSubmission:DateofSubmission:BIBLIOGRAPHYOFSUBMITTEDSTUDIESThidiazuron-Diuron4.5SC66330-364ResponsetoAgencyLetterDatedApril13,2009June18,20091of1AcuteOralToxicityUpandDownProcedureinRats27522870.1100Page1of1AcuteTox47783901

### UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, 

### D.C. 20460

CERTIFIEQ MAlL 

# APR 1 3 2009 OFFICE OF PREVENTION, PESTICIOESAND TOXIC SUBSTANCES



### Mr. Bill Washburn 

### Arysta 

### LifeScience 15401 Weston 

### Parkway, Suite 

### 150 Cary, NC 

### 27513

.sUBJECT: 

### Thidiazuron Reregistration Eligibility Decision (RED), Review of Acute Toxicity 

### Data, EPA Registration Number 

### 66330·364

Dear Mr. Washburn:



### Your request 

### to cite acute toxidty data required In response to 

### the Thidiazuron Product Specific Data Call-In Notice 

### has been reviewed. You cited studies conducted on 

### your product, EPA Registration Number**66330~36~** 

### which were previollslyreviewed and with exception 

### to acute oral 

### 81-l were determined 

### to be acceptable. The acute oral 

### study

was determined to be unacceptable.

The acute toxicity profile for EPA Registration No. 66330-364 is currently:

Guideline 

### Study Toxicity Category 

### Classification

81·1 Acute Oral Unacceptable 

### 81-2 Acute Dermal 

### IV Acceptable 

### 81·3 Acute Inhalation 

### IV Acceptable 

### 81-4 Primary Eye 

### IV Acceptable 

### 81·5 Primary Dermal 

### IV Acceptable

. 

### 81-6 SIdn Sensitization non sensitizer Acceptable

You are required to cite or submit acceptable data to 

### satisfy Guideline 

### 81-1pcute oral, within 30 days from your receipt of 

### this letter. Within ten days from your receipt of this letter, you must notify the Agency how you will fulfill 

### this data requirement. Your failure to submit 

### data within the due dates may result in your receiving a Notice' of Intent to Suspend your product's registration. A detailed copy 

### of the Data Evaluation Record is enclosed. If you have any questions, you may contact Barbara Briscoe,at 703-308-8177.

Sincerely,

# -Patu~or 

# fLUu-.

Patricia L. Moe, Chief Product Reregistration Branch Special Review and Reregistration Division Enclosure

# e Arysta LifeScience

VIA FED EX DELIVERY (Tracking No. 7967 0543 8755)



### Ms. Barbara L. Briscoe, Chemical Review Manager Product Reregistration Branch 

### Special Review and Reregistration Branch 7508P Office of Pesticide Programs 

### U.S. Environmental Protection Agency Room 5-4900, One Potomac Yard 2777 South Crystal Drive 

### Arlington, VA 22202

Dear Ms. Briscoe:
Subject: ThidiazuronwDiuron 4.5 SC EPA Reg. No. 66330-364


### Response to Agency Letter Dated April 13, 2009

Please find enclosed the following documents in support of the subject product.

1. EPA Faun 8570w1 (Application for Registration Amendment) 477839-00



### June 18, 2009

One copy 

### of EPA Form 8570-1 (Application for Registration Amendment) dated June 17, 2009. This is not a PRIA action.

2. BibliographY,of Submitted Studies



### One copy of the Bibliography of Submitted studies (transmittal document) describing the submitted data in support of this registration application is enclosed.



### 3. Study Reports

Three bound and labeled copies of each study described in the Bibliography of 

### Submitted studies
are enclosed.

Please call on me af the e-mail address or telephone number shown below if you require any additional information or assistance in this matter. Thank you for your time and assistance in the registration of 

### this product. - "

Arysta LifeScience North America, LlC 

### Very truly yours,

Bill Washburn Regulatory Manager

Phone: (901) 432-5118 E-Mail: bill.washburn@arvstalifescience.com

15401 weslon ParKway, SuHe 150, Cary, NC 27513 Phone 919-678-4900 Fax 919-678--2194 www.arystallfescience.comArystaLifeScienceNorthAmerica,LLC15401WestonParkway,Suite150Cary,NorthCarolina27513ProductName:EPARegistrationNumber:PurposeofSubmission:DateofSubmission:BIBLIOGRAPHYOFSUBMITTEDSTUDIESThidiazuron-Diuron4.5SC66330-364ResponsetoAgencyLetterDatedApril13,2009June18,20091of1AcuteOralToxicityUpandDownProcedureinRats27522Page1Of1AcuteTax47183901

# • 

# ,**PI",,~d,** reverse before completing form. Form Approved, OMB No. 2070-0060, Approval



# - EPA United States 

### D Registration OPP Identifier Number 

# 0 Environmental Protection Agency 

# o Amendment



# ,
, DC2Q460 Other: 

### i for Pesticide**~** 

### Section I



# ,. 

# ,. ,

# ~ 'IN'm'l I 4.5 SC eM. ONona 

# D Restricted

5. N'm, 

# , ' Cod,) 6. Ii. In ! flFKA i
Arysta LifeScience North America, LLC (b)(I), my product is similar or identical in composition and [ I". 

### to: 15401 Weston Parkway, Suite 150 

### Cary, NC 27513 EPA Reg. No.

Product Name 

# n Ch,ddf""" 

### Section**~** 

### II


## .

Amendment

- Explain below. Fina! printed labels in response to Agency letter dated _4113/09_ Resubmission in response to Agency letter dated

__ "Me**Too~** Apprlcalion



## . """"0**b,'~.** 

## I**O~,,·** Eo".'o**b,'~** 

# , , 

# , '" (For 

### i I and
, 11.)

Response to Agency letter dated April 13, 2009 .•



### Section**~** 

### III

. 

# , 

# , ,


# , 

# ,**;"~~s** ,

Yes' y"

### ~ Meta! No 

## I No Plastic

### !~:Y.?: No. poe

## ~a~:~ewgt**~?~'per** Glass 

# I**.certi~iCatiOn** must 

# , wgl. 

# , container

# ~ 4. 

# , , , Label 

# o Container

### ~ On Label 2.5 gat, 5.0 gal., and 30 gal. 

## 100'**lP""'~** 6. h Label i
, 10 Pcod," 

# , U Olh".



## . 

# , 

# ... Section**~** 

### IV 

## ••••

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## N~~L WASHBURN 

# ,,", • >No., REGULATORY MANAGER 

### . "

## 901-ire2~118 

# , .I.

, ':",. I'


# , ! have made on tllis form 

# " tllereto are true, accurate and complete. I 

# .. , or misleading statement may be punishable by ina or implisonment or both , , (Stamped) 

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# . •••• 2.

# ~;~~LATORY MANAGER 

### , • > • , •



## , 

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### ,**~** 

# .. BILL' June 

### 18. 2009

, (R"',
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# , 

# , 'Copy

### US Postal Service '" 

## CERTIFIED MAIL

.. RECEIPT aded) 'c Mail Only; No InSIlr.Jn&e Coverago

# RetumRecelpl~e)**t======I~:::!:~;~10;f** Acute {EndQfSement ReqW**R~dDellYeryFee** Data (Endorsemenl Requ1red)

ITED STATES POSTAL SERVICE

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### USPS Permit No. G-10 

# 111111

• Sender: Please print your name, address, and Zrp+4 in this box •

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# sRim
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.. , 

### 1:200'

# Pennsyi,~~ni~**.,-Av.~:~~i"e,** NW I, 

### '**Washington~** 

### :DC 2-0460 '

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### J.II II 

### JlII.'III.1

### Certified

### lVI~il. Provides:
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### ,it

, ., • A Unique idsnrifler for your matlpiece • A reCOrd of delivsry kept by the Postal Sel'\rice for two years importallt Reminders:

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deu\IeIY. To obtain Retum Receipt serVIce, Please com.oiete and attach a Rmum Receipt (PS Form 3811) to Ihe article and add apptjcable postage to cover/he fee, Ern:lQrse maNplece 'Return Receipt Requested', To receive a fee waiverfor a

## dup~cate return receipt, a

## USP~ POStmark on your Certified Mail receipt is /'eqU1r&.l,

• For an addiflonal fee, delivery may be restrlcled to the

## addres~e or

addressee's authorized agent Advise the Clerkar mark the

## ma~pjece with the eooOJsement "ResllictedDelivery".

• /f a POstmark on the Cenitied Mail receipt Is desirea, otease present the article at the Post office tor postmarking, If a POstmark on the Certitled Mall receipt Is not needed, detach and affix tabel With postage and

### ma~. IMPORTANT: SaVe thIs recefpl and presenl" when making an inquIry. PS Form 3800, AlltlUS121lO6

### (Re~rse) PS/II 75S0-02-000.S047

2 and 3 Also complete •

### Compl~te**ite~** 

# ct!d OerrverY is desired. item 4 if Restrl d address on the reverse • PrInt your name.an n the card to you.

so thai 

### we can

### retu~ back of the mal/pIece, • Attach thIs card to e its

or on the front if space penn

.



### M Bill Washburn



### r.

15401 Weston**Parkway~** 

### Cary; NC 27513 item 11 O. II YES, enterde)ivery addmss belcw:



### . (11ansfer'tbm Set wc6 !8b"" Domestic Retum Receipt S

## ~orm 3811, Febru8IY 2004 ONo

### \



# ,

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

### WASHINGTON, D.C. 20460

CERTIFIED MAIL 

# APR 1 3 1009 OFACEOF PREVENTION, PESTICIOES AND TOXIC SUBSTANCES



### Mr. Bill Washburn Arysta 

### LifeScience 15401 

### Weston Parkway, Suite 150 

### Cary, NC 27513



### SUBJECT: Thidiazuron Reregistration Eligibility Decision (RED), Review of Acute Toidcity Data, EPA Registration Number 66330-364

Dear Mr. Washburn:



### Your request to cite acute toxicity data required 

## in response to 

### the Thidiazuron Product Specific Data Call-In Notice 

### has been 

### reviewed You cited studies conducted on your product, EPA Registration Number 66330-36:1; which were previously reviewed and 

### with 

### exception to acute oraIB!-! were determined to 

### be acceptable. The acute oral study

was determined to 

### be unacceptable;

The acute toxicity profile for EPA Registration No. 66330-364 is 

### currently:



### Guideline Study Toxicity 

### Catego:ry Classlficati on

81-1 Acute Oral 

### Unacceptable 81-2 

### Acute Dermal IV 

### Acceptable 81-3 Acute Inhalation 

### IV 

### Acceptable 81-4 Primary Eye 

### IV Acceptable 81-5 

### Prbnary Dermal 

### IV Acceptable

. 81-6 Skin Sensitization non sensitizer 

### Acceptable

You are required to 

### cite or submit acceptable data to satisfy Guideline**81~lfcute** 

### oral, within 

### 30 days from your receipt of 

### this letter. Within ten days from your receipt of 

### this letter, you must notify the Agency how you will fulfill this data requirement. Your failure 

### to submit 

### data within the due dates may result in your receiving a Notice of Intent to 

### Suspend your**pr~uct's** 

### registration. A detailed copy of the Data**Evalu~tion** 

### Record is enclosed. If you have any questions, you may contact Barbara Briscoe at**703~308..g177.** 

### Sincerely,

# Yw.a~~or 

# fL<.JJ-L

Patricia L. Moe, Chief Product Reregistration Branch 

### Special Review and Reregistration Division Enclosure

## ) UNI1 ED STATES ENVIRONMENTAL PROTEC1.ON AGENCY WASHINGTON, D.C. 20460



### January 13, 2009

ARYSTA LlFESCIENCE NORTH AMERICA, LLC 1540 I WESTON P ARKW A Y, SUITE 150 CARY, NC 27513-

Report of Analysis for Compliance with PR Notice 86-5 OFFICE OF PREVENTION, PESTICIDES AND TOXIC SUBSTANCES



### Thank you for your submittal of 12-JAN-09. Our staff has completed a preliminary 

### analysis of the material. The results are provided as follows:

Your submittal was found to be 

### in full compliance 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. Please use these numbers in all future 

## references to these documents. 

## Thank you for your cooperation. If you have any questions concerning this data submission, please raise them with 

## the cognizant Product Manager, to whom the data have been released.Page 2 of2



### 4. EPA Form 8570-34 (Certification with Respect to Citation of Datal

One copy of EPA Form 8570-34 (Certification with Respect to Citation of Data) is enclosed. The selective method of support (or cite-all option under the selective method) has been checked in Section I and the General Offer to Pay has been checked in Section II.

5. EPA Form 8570-27 (Formulator's Exemption Statement)

One copy of EPA Form 8570-27 (Formulator's Exemption Statement) identifying registered source of active ingredient used in this formulation.

6. Draft Label for Thidiazuron-Diuron 4.5 SC

Five copies of a draft label for Thidiazuron-Diuron 4.5 SC, one redlined copy (Filename: Thidiazuron-Diuron 4.5SC(364-021607)AD092107 RED 

### + PR 2007-4**(Redline).pd~** 

### and four clean copies (Filename: Thidiazuron-Diuron 4.5SC(364-021607)AD092107 RED 

### + PR 2007-4 (Clean).pdD are enclosed.

7. Bibliography of Submitted Studies

One copy of the Bibliography of Submitted Studies (transmittal document) describing the submitted data in support of this registration application is enclosed.

8. Study Reports

Three bound and labeled copies of each study described in the Bibliography of Submitted Studies are enclosed.

Please call on me at the e-mail address or telephone number shown below if you require any additional information or assistance in this matter. Thank you for your time and assistance in the registration of this product.

Very truly yours,

Bill Washburn Regulatory Manager

Phone: (901) 432-5118 E-Mail: bill.washburn@arystalifescience.comArystaLifeScienceNorthAmerica,LLC15401WestonParkway,Suite150Cary,NorthCarolina27513BIBLIOGRAPHYOFSUBMITTEDSTUDIESProductName:Thidiazuron-Diuron4.5SCEPARegistrationNumber:66330-364PurposeofSubmission:DataCall-InDateofSubmission:January10,20091of1StorageStabilityofThidiazuron-Diuron4.5SCwithCorrosionCharacteristicsMI-0604OPPTSIGroupA-830.6317ProductPage1of147641101

# e AQ'sta LifeScience

VIA FEDEX DELIVERY (Tracking No. 7962 4461 3810)

Ms. Barbara L. Briscoe, Chemical Review Manager Product Reregistration Branch Special Review and Reregistration Branch 7508P Office of Pesticide Programs U.S. Environmental Protection Agency Room 8-4900, One Potomac Yard 2777 South Crystal Drive Arlington, VA 22202

Dear Ms. Briscoe:

Subject: Thidiazuron-Diuron 4.5 SC EPA Reg. No. 66330-364



### 8-Month Response to Data Call-In dated 5/08/08 476411-00

January 10, 2009

Please find enclosed the following items in support of the subject product as requested by the Product Specific Data Call-In for products containing thidiazuron dated May 8, 2008:



### 1. EPA Form 8570-1 (Application for Registration Amendment)

One copy of EPA Form 8570-1 

### (Application for Registration Amendment) dated January is enclosed. The application is the 8-Month Response to the Data Call-In dated May 8, 2008.



### 2. EPA Form 8570-4 

### (Confidential Statement of 

### Formula)

Two copies of EPA Form 8570-4 

### (Confidential Statement of 

### Formula) dated December 20,2008 are enclosed. This form specifies the nominal concentration of the technical grade active ingredient and each of the organic impurities identified in the Group A product chemistry studies. Standard upper and lower certified limits as per 40 CFR §158.175(b)(2) have been entered for the active ingredient and each of the impurities.

3. EPA Form 8570-35 

### (Data Matrix)

One copy each of EPA Form 8570-35 

### (Data Matrix) in two formats are enclosed. The form is submitted in a non-redacted version ("Agency Internal Use Copy") and a redacted version ("Public File Copy") as per Pesticide Registration Notice 98-5. The Public File Copy does not show the guideline reference number, the guideline study
name, and the MRID number but it does indicate the submitter and status of the data.

Arysta LifeScience North America, LLC 15401 Weston Parkway, Suite 150, Cary, NC 27513 Phone 919-678-4900 Fax 919·678·2194 www.arys1alifescience.comPage 2 of 2



### 4. EPA Form 8570-34 

### (Certification with Respect to Citation of 

### Data)

One copy of EPA Form 8570-34 

### (Certification with Respect to Citation of 

### Data) is enclosed. The selective method of support (or cite-all option under the selective method) has been checked in Section I and the General Offer to Pay has been checked in Section II.

5. EPA Form 8570-27 

### (Formulator's Exemption Statement)

One copy of EPA Form 8570-27 (Fonnulator's Exemption Statement) identifying registered source of active ingredient used in this formulation.

6. Draft Label for Thidiazuron-Diuron 4.5 SC

Five copies of a draft label for Thidiazuron-Diuron 4.5 SC, one red lined copy (Filename: 

### Thidiazuron-Diuron 4.5SC(364-021607)AD092107 RED 

### + PR 2007-4**(Redline}.pd~** 

### and four clean copies (Filename: 

### Thidiazuron-Diuron 4.5SC(364-021607)AD092107 RED 

### + PR 2007-4**(Clean).pd~** 

### are enclosed.

7. Bibliography of Submitted Studies

One copy of the Bibliography of Submitted Studies (transmittal document) describing the submitted data in support of this registration application is enclosed.

8. Study Reports

Three bound and labeled copies of each study described in the Bibliography of Submitted Studies are enclosed.

Please call on me at the e-mail address or telephone number shown below if you require any additional information or assistance in this matter. Thank you for your time and assistance in the registration of this product.

Very truly yours,

Bill Washbum Regulatory Manager

Phone: (901) 432-5118 E-Mail: bill.washburn@atvstalifescience.com

## \ 

# e**A~sta** LifeScience

VIA FEDEX DELIVERY (Tracking No. 7962 44613810)

Ms. Barbara L. Briscoe, Chemical Review Manager 

### Product Reregistration Branch Special Review,and Reregistration Branch 750BP Office of Pesticide Programs 

### U.S. Environmental Protection Agency Room 8-4900, One Potomac Yard 2777 South Crystal Drive Arlington, VA 22202



### Dear Ms. Briscoe:

Subject: Thidiazuron-Diuron 4.5 SC EPA Reg. No. 66330·364



### 8-Month Response to Data Call-In dated 

### 5/08/08 476411.00

January 10, 2009

Please find enclosed the following items in support of the subject product as requested 

### by the Product Specific Data Call-In for products 

### -containing thidiazuron dated May 8, 2008:



### 1. EPA 

### Form 8570-1 (Application for Registration Amendment)



### One copy of EPA Form 8570-1 (Application for Registration Amendment) 

### dated January is enclosed. The application is the 8-Month Response to the Data Call-!n dated May 8, 2008.



### 2. EPA Form 8570-4 

### (Confidential Statement of 

### Formula)

Two copies of EPA Form 8570-4 (Confidential Statement of Formula) dated December 20, 2008 are enclosed, This form specifies the nomina! concentration of the technical grade active ingredient and each of the organic impurities identified in the Group A product chemistry studies. Standard upper and lower certified limits as per 40 CFR §158.175(b)(2) have been entered for the active ingredient and each of the impurities.

3, EPA Form 8570·35 

### (Data Matrix)

One copy each of EPA Form 8570-35 (Data Matrix) in two formats are enclosed, The form is submitted in a non-redacted version (,Agency Jnterna! Use Copy") and a redacted version ('Public File Copy") as per Pesticide Registration Notice 98-5. The Public File Copy does not show the g,uideline reference number, the guideline study name, and the MR!D number but it does indicate the submitter and status of the data.

Arysta UfeScience North Amerlca, LlC 15401 Weston Parkway, Suite 150, Cary, NC 27513 Phone 919-678-4900 Fax 919-678-2194 www.aryslalifescience.ccmArystaLifeScienceNorthAmerica,LLC15401WestonParkway,Suite150Cary,NorthCarolina27513.BIBLIOGRAPHYOFSUBMITTEDSTUDIESProductName:Thidiazuron-Diuron4.5SCEPARegistrationNumber:66330-364PurposeofSubmission:DataCall-InDateofSubmission:January10,20091of1StorageStabilityofThidiazuron-Diuron4.5SCwithCorrosionCharacteristicsMI-0604830.6317IProductPage1-of147641101Please read inslructions on reverse before comp, 

# , J form. 

### Tn Approved, OMB No. 2070-0060, Approval 

### "p'''' 

# '"' 

# EPA United states 

# o Registration QPP Identifier Number 

# 0 Environmental Protection Agency 

# o Amendment Washington, DC 20460 

## I2l Other: 

### for Pesticide**~** 

### Section I 1. 2. 3. 

### I

4. eM. 

# o None 

# o RestricJed 

### I**,,~n~ 4~5**  

### SC
5. Ii I (loolud' Z<P COd'l 

### 6. i In accordance with FIFRA i**~ ~(~)\~)**  

### Arysta LifeScience North America, LLC (b)(I), my product is similar or identical in composition and Ii, '::l 

### to: 15401 

### Weston' Parkway, Suite 150 

### EPA Reg. No. Cary, NC 27513 

### Product Name 

# _.0 Check if this is a 

### Section -II

Amendment:... EXplain below. Final printed labels in response to Agency letter dated Resubmission in response to Agency letter daled

__ "Me Too" Applicalion

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### , . E",I,'o b,'ow, I Ofu,,·1 

### I '""_.



### : Use i 

### ) if 

### necessary. (For: I and I 

### 11.)

. 

### 8·Month Response to Data Call-In dated May 8, 2008 

### for product containing thidiazuron.



## . Section

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, 

# , ",-,' YP"**y~'**

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# NO,p" No. poe Glass 

### *Certification must wgl. Paper 

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# o Container

## _~ On Label 2.5 gal., 5.0 gal., and 30 gal. I 00 Ii 

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### IV

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# N~~~L WASHBURN 

# I**T'tI~EGULATORY** MANAGER 

# c;;;-;j

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### • 9014'32·5118
6. 

### Ii I 

# , I have made on Ihis form and all attachments Iherelo are true, acctJrate and comple1e. I**;~~I,any** knowingly false or misleading statement may be punishable by fine or imprisonmenl or**bot~** , 

# :-

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, ,**,~**-UNITEDSTATESENVIRONMENTALPROTECTIONAGENCY401MStreet,S.W.FormApprovedOMBNo.2070-0060oWASHINGTON,D.C.20460....::1Notice:""'"I'UU"'",,,,,,,,UIUII!,JUUIU"'"IU'U",.<AJ.._vuy,._....._.,Inandspecialreviewactivifies,includinglimeforreadingtheinstructionsandforreducingtheburdento;Director,OPPE'•;0'(2-137),u:s.Environmental-ProtectionAgency,4UlM::ilreet,>:>.VV.,vv8smnglon,u\.,;O!U'ItJu.DonotsendtheJormtoDATAMATRIXDaleDecember20,2008EPAReg.No.lFileSymbol-)I::>....""'''''''''...ProductArystaUfeScienceNorthAmerica,LLC,15401WestonParkway,Suite150,Cary,NC27513.uIlIRON4.5SCIngredienl(s):Thidiazuron,DiuronNumberStudyNameMRIDNumberSubmitterStatusChemistry830.AAmsillon,etal47070601AstaLifeScienceNorthAmerica083u.1::iitandicalCharacteristics47070602staUfeScienceNorthAmerica0..100870.1200870.1300870.2400870.2500870.2600SIgnatureOralT..I\cuteDerm;:InhalaiionI (EyeIrritationDermallrritalion_A'''__''__EPAForm8570.35IS·S7IP.<IM'""",ion".':Llbmllno'..,Iyversion.)70603170604--'70605706067060770608UfeSc·UfeS,ArysiaNameand_Title:BillWashbum,-RegulatoryManagerIPage10f1NoleDate12/20/2008AgencyIntornalUscCopy-orocDate20,2008UNITEDSTATESENVIRONMENTALPROTECTIONAGENCY401MStreet,S.W.WASHINGTON,D.C.20460the'.Director,DATAMATRIXEPAReg.No.lFileSymbol66330·364ArystaLifeSclenceNorthAmerica,LLC,-15401Weston,Parkway,Suite150,Cary,NC27513Ingredient(s):Thidiazuron,Diuron.Slgna,tureNama,:,-"BillWashburo,:RegulaloryManager••••_______••__.,.-..,IyPapervers;oo,FormApprovedOMBNo.2070-0060oranyotheraspectMStreet,S.W.,Washington,DC20460.0'1Date12/20/2008AgencyrniimalU$eCopy

## .. .•.**~.~ ~~-**  

# - UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

# 0 401 M Street, S.W. WASHINGTON, D.C. 20460
Paperwork Reduction Act Notice: The public reporting burden for this collection of information is estimated to average t.25 hours per response for registration activities and 0.25 hours per response for reregistration and special review activities, Including time for reading tlie instructions and completing the necessary folTTlS. Send comments regarding the burden estimate orany other aspect of this collection of infonnation, including suggestions for reducing the burden to: Director, QPPE Infonnation Management Division (2137), U.S. Environmental Protection Agency, 401 M Street, S.W., Washington, DC 20460. Do not send the form to this address.
Certification with Respect to Citation of Data Applicant's/Registrant's Name, Address and Telephone Number EPA Registration Number/ Rle Symbol Arysta LifeScience N. A. LLC, 15401 Weston Parkway, Suite 150, Cary, NC 27513 66330-364 Active Ingredient(s) and/or representative test compound{s): Date Thidiazuron, Diuron December 20 2008 General use pattem(s) (list all those claimed for this product using 40 CFR Part 158) Product Name Terrestrial, Non-Food Use (Cotton) TlDDIAZVRON-DIlIRON 4.5 SC

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. You must submit the Formulator's Exemption Statement (EPA Form 8570-27). 

## 00 I am responding 

### to a Data Call-In Notice, and have included with this form a list of companies sent offers of compensation (the Data Matrix form should be used for this purpose).
SECTION I: METHOD OF DATA SUPPORT (Check one method only) 

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

### (gJ I am using the selective method of support (or cite-all option' this form a list of companies sent offers of compensation (the under the selective m'ethod); and have included with this form a Data Matiixform should be used for this purpose). completed list of data requirements (the Data Mabix 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 requirementsJ 

### (gJ I hereby offer and agree 

### to pay compensation, 

### to other persons, with regard 

### to the approval of this application, 

### to the extent r,equired by FIFRA.

SECTION III: CERTIFICATION .

c I certify that this application for registration, this form for reregistration, or this Data Call-In Notice is supported by all data submitted
or cited in the application for registration, the form.for reregistration, or this Data Call-In response. In addition, if cite-a'lI option under the selective method is indicated in Section I, this application is supported by all data in the Agency's files that (1) concem the properties or effects of this product or an identical or substantially similar product, or one or more of the ingredients in this product; and (2) is a type of data that would be required to be submitted under the data requirements in effect on the date of approval of this application if the application sought the initial registration of a product of identical or similar composition and uses.

I certify that for each exclusive use study c'lted in support of th'ls registraflon or reregistration, that I am the original submitter or that I have obtained the written permission of the original submitter to cite that study.

I certify that for each study cited in support of this registration or reregistration that is not an exclusive use study, either. (a) I am the original data submitter, (b) I have obtained the written permission of the original data submitter to use this study in support of this application; (c) all periods of eligibility for compensation have expired for the study; (d) the study is in the public literature; or (e) I have notified in writing the company that submitted the study and have offered (i) to pay compensation to the extent required by sElctions 3(c)(1)(f) and/or 3(c)(2)(8) of FIFRA; and (ii) to commence negotiations to determine the amount and terms of cOmpensation, if any, 

### to be paid for the use of the study.

I certify that in all instances where an offer of compensation is required, copies of all offers 

### to pay compensation and evidence of their delivery in accordance with sections 3(c)(1)(F) and/or 3(c)(2)(8) of FIFRA are available and will be submitted to the agency upon request. Should I fail to produce such evidence to the Agency upon request, I understand that the Agency may initiate action to deny, cancel or suspend the registration of my product in conformity with FIFRA.

I certify that the statements I have made on this form and all attachments to it are true, accurate and complete. ! acknowledge that any knowingly false or misleading statements may be punishable by fine or imprisonment or both under applicable law.

Signature

# C6~G.:,=~ D,., Typed or Printed Name and Title 12/20/08 Bill Washburn, Regulatory Manager



## . .**.~,** EPA Form 8570 34 (9 97) ElectrOniC and Paper vf' 'Ins available. Submit only Paper version

. ,Form aooroved. OMS NO. 2070-0060. Aooroval Exoires 1-30-93 United States Environmental Protection Agency 

## I'l1o Washington, D.C. 20460 

# o EPA Formulator's Exemption Statement (40 CFR 

## 152.85) Applicanfs Name and Address EPA File Symbol/Registration Number Arysta lifeScience North America, lLC 

### 66330-364 15401 Weston Parkway, Suite 

### 150 Product Name Cary, NC 

### 27513 THIDIAZURDN·DIURON 4.5SC Date of Confidential statemen1 of Formula (EPA Form 8570-4) 12120/08



### As an authorized representative of the applicant for registration of the product identified above, I here certify that: (1) This product contains the following active ingredient(s): Diuron

(2) Of these, each active ingredient listed in paragraph (4) is present solely as the result of the use of that active ingredient in the manufacturing, formulation or repackaging of another product which contalns that active ingredient, which is registered under FIFRA Section 3, is purchased by us from another producer, and is labeled for at least each use for which my product is proposed to be labeled.
(3) Indicate by checking (A) or (8) below which paragraph applies: 

# IZI (A) An accurate Confidential Statement of Formula (EPA Form 8570-4) for the above identified product is attached to this statement. That formula statement indicates, by company name, registration number, and. product name, the source of the active ingredient(s) listed in paragraph (1). OR 

# '0 (8) The Confidential Statement of Formula (CSF) (EPA Form 8570-4) referenced above and on fIle with the EPA is complete, current, and accurate and contains the information required on the current CSF.

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

Source

Active InQredient Product Name ReQistration Number

Diuron



### Or



### " 

## , , ,

, 

## "

, , " " 

## , , ,

. '" ,



## .
, 

## , Signature Name and Title Date**~.~:--.** , "."

, 

### ,

# ~~~~ Bill Washburn, January 1"e,02o09 

### " 

### ,**Regulat~ry** Manager 

### , 

## , "


### , , 

### , , 

## "

, ;- EPA Form 8570-27 (Rev. 7-91) White

- EPA copy )all,Jw-Apphcant copy '"" 

## ,
"

# r.:==========~--~U);$S..~E~NV~IRRIO~MENTALPROTECTION AGENCY Office of Pesticide Programs 

### Registration Division (750SP) Ariel Rios Building 1200 Pennsylvania Ave., NW

Washington, D.C. 20460



### NOTICE OF PESTICIDE, L Registration



### _ Reregistration (ooder FIFRA, as amended)

Name and Address of Registrant (include ZIP Code): 

### Arysta LifeScience North America Corporation IS40 1 Weston Parkway, Suite ISO Cary, NC 27S13 EPA Reg. Number: Date of Issuance:


### 66330-364

::'·.i,

Term oflssuance: 

### Conditional

Name of Pesticide product:


### Thiadazuron-Diuron 4.SSC

_ Note: Changes.in labeling differing in substance**~~** thatA!ccejlted in coynCction**~** this, rcgi.stranpn rollSi be submitted to and accepted by th,e

:**Reci~tration** Division nrior to use' of the label in cOmmerce.:

- 

### hnmv**c~nden<:e** on this 'nrociuct 'a1wavs refer to 

### the above EPA**re!li~tion** number.

On the basis of information furnished by the registrant, the above named pesticide is hereby registered under the Federal Insecticide, Fungicide and Rodenticide Act Registration is in no way to be construed as an endorsement or recoriunendation of this product by the Agency. In order to protect health and the environment, the Administrator, on his motion, may at any time suspend or eancel the registration ofa pesticide in accordance with the Act. The acceptance ofany name in COlUlection with the registration ofa product under this Act is not to be construed as giving the registrant a right to exclusive use of the name or to its use ifit has heen covered by others.



### This product is conditionally registered in accordance with 

### FIFRA sec. 3( c )(7)(A), provided that you make the following revisions:

1. Submit information to upgrade, or repeat, the Acute Oral Toxicity study. In 

### the interim, the label must have the signal word, "DANGER," and the corresponding precautionary
statements: "Fatal if swallowed. Wash thoroughly with soap and water after handling and before eating, drinldng, chewing gum, or using tobacco.



### 2. Precautionary Statements- Hazards to Humans and Domestic Animals section: Based on the acute toxicity profile of this product, the statement, "Causes moderate eye irritation," is not required, and may be removed.



### Comments continued on**Da~e** 

## 2 of this refTistration notice

Signature of Approving Official:**~** 

# k _ t{h'" 

# /lfJ Joannel.Miller**~_ /I~**  

### Product Manager 23 Herbicide Branch Date:



## SEP 2 1 2007 Registration Division (7S0SP)

EPA Form 8570-6

### Page 2 EPA Reg. No. 66330-364 Comments, Continued:

3. The Personal Protective Equipment statements must read as follows: "Personal Protective Equipment (PPE)" "Some materials that are chemical-resistant to this product are" 

### [registrant inserts correct chemical-resistant material]. "If you want more options, follow the instructions for category" 

### [registrant inserts A,B,C,D,E,F,G, or Ii] 

### "on an EPA chemicalresistance category selection chart." "All pilots, flaggers, and groundboom applicators must wear: Long-sleeved shirt and long pants, and Shoes plus socks" 

### "All mixers, loaders, other applicators, and other handlers must

wear: Long-sleeved shirt and long pants, Shoes plus socks, Chemical-resistant gloves, such as barrier laminate or butyl rubber, A NIOSH-approved dust/mist filtering respirator with any N 2

, 

### R, P, or HE filter, or a NIOSH-approved dust/mist filtering respiI:ator with approval number prefix TC-21 C, and Chemical-resistant apron when mixing, loading, or cleaning equipment or spills." See Engineering Controls for Additional Requirements

4. Place the paragraph beginning, "Discard clothing and

... " into a box entitled, "User Safety Requirements."

5. Engineering controls: Add the follOwing statement:

a. "Pilots must used an enclosed cockpit that meets the requirements listed in the Worker Protection Standard (WPS) for agricultural pesticides [40 CFR 170.240(d)(6)]. Flaggers supporting aerial applications must use an enclosed cab that meets the definition 

### in the WPS [40 CFR 170.240(d)(5)] for dermal protection. 

### In addition, flaggers must wear long-sleeved shirt, long pants, shoes, and socks.

6. Environmental Hazards: Add the following text to the current environmental hazards text:

a. "Apply this product only as specified on this label." "This product may contaminate water through 

### drift of spray in wind. This product has

a high potential for runoff for several months or more after application. Poorly draining soils and soils with shallow water tables are more prone to produce runoff that contains this product. A level, well-maintained vegetative buffer,strip between

areas to which this product is applied and surface water features, such as ponds, streams, and springs, will reduce the potential for contamination of water from runoff. Runoff of this product will be reduced by avoiding applications when rainfall is forcast to occur 

### within 48 hours. Sound erosion control practices will reduce this product's contribution to surface water contamination." "This product has properties and characteristics associated with chemicals detected in ground water. Use of this chemical in areas where soils are permeable, particularly where the water table is shallow, may result in ground water contamination."

### Page 3 

### EPA Reg. No. 66330-364 Comments, Continued

7. Spray Drift Management: The following language must be added to the label:

a. "Requirements for reducing spray drift for diuron ground and aerial applications." b. "Use best practices to avoid drift to all other crops and non-target areas. Do not apply when conditions favor drift from target areas. The interaction of many equipmentand weather-related factors determine the potential for spray drift. Avoiding spray drift at the application site is the responsibility of the applicator. The applicator must follow the most restrictive precautions to avoid drift, including those found in this labeling as well as applicable state and local regulations and ordinances. A drift control agent may reduce drift, however, it may also decrease weed control."

c. "Make aerial or ground applications only when the wind speed is less than or equal to 10 miles per hour." d "Do not make aerial or ground applications into temperature inversions."

e. "Apply with medium or coarser spray (according to ASAE standard 572) for standard nozzles." f. "Additional requirements for ground applications: When applying to 

### crops, apply with nozzle height no more than 2 feet above the ground or crop canopy." g. "Additional requirements for aerial applications: The spray boom should be mounted

on the aircraft so as to"minimize drift caused by wing tip vortices. The boom length
must not exceed 75% of the wingspan or 90% of rotor blade diameter." h. "Use upwind swath displacement."

1. 

### "Do not release spray at a height greater than 6 to 

### 10 feet above the ground or crop canopy." J. 

### "Do not apply by air if sensitive non-target crops are within 100 feet of the application site. "

8. Rio Grande Valley of Texas Procedures to Lower Spray Drift Potential: Add the following
statement to this section: "Do not apply by air within**~** 

### mile oflettuce. Ground applications

are restricted to 100 feet away from lettuce."

9. Dosage Information: Add the following statement after the statement beginning, "The maximum annual use rate

.... ": "Do not make more than 2 applications per year. Minimum
retreatment interval of2l days."

10. Submit the following data 

## required for the registration of this pesticide product within I year from the date of this Notice of Registration:



### EPA Guideline Number: 

### 830.6317 830.6320 Study Description: 

### Storage Stability Corrosion Characteristics

11. Submit and/or cite all data required for the registration of this product when the Agency requires all registrants of similar product to submit data.



### 12. Add the statement, "EPA Reg. No. 66330-364."

13. Submit one copy of the final printed label before the product is released for shipment.

A stamped copy of the label is enclosed for your records.

# THIDIAZURON-DIURON 4.5SC
COTTON DEFOLIANT
For Agricultural Use Only ACTIVE INGREDIENTS: Thidiazuron: N-phenyl-N'-1 ,2,3-thidiazol-5-ylurea*

........................... 36.06% 

### Diuron: 3-(3,4-dichlorophenyl)-1) 1-dimethylurea*

............... '"

................ ,'

......... '

.. '"

............. 18.04% Other Ingredients:

.................. "

......................... '" "

................... "

.................................. 45.900/0 

### TOTAL 100.00%

Contains 3 lb. Thidiazuron per gallon and 1.5Ib. Diuron per gallon

KEEP OUT OF REACH OF CHILDREN CAUTION 

### Si usted no entiende la etiqueta, busque a alguien para que 5e 

### la explique a usted en detalle. (If you do not understand this label, find someone to explain 

### it to you in detail.)

FIRST AID IF SWALLOWED: 

## • Immediately call a poison control center or doctor for treatment advice.


## • Do not induce vomiting unless told to do so by a poison control center or doctor. 

# • Have person S'IP 

### a glass or water 

### if able to swallow. 

# • Do not aive anythinq by mouth to an unconscious person. 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. NOTE TO PHYSICIAN: Probable mucosal damage may contraindicate the use of gastric lavage.
HOT LINE NUMBER 

### Have the product container or label with you when calling a poison control center or doctor
or going for treatment. EMERGENCY NUMBERS: FOR 24· HOUR EMERGENY MEDICAL ASSISTANCE CALL: 1·866·303·6952 

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

SEE INSIDE (SIDE PANEL) FOR ADDITIONAL PRECAUTIONS AND USE DIRECTIONS



### EPA Reg. No. 66330-xxx ADxxxxxx EPA Est. No. 51036-GA-001 NET CONTENTS:

__ _


### Manufactured by Arysta LifeScience North America Corporation 15401 Weston Parkway, Suite 150 Cary, NC 27513


# ACCEPTED with COMMENTS In EPA Letter Dated: 

# SEP 2 1 2007
Under the 

### Federal**bL~cide.,** 

### Fungicide, and 

### Rodenticide Act


### as 

### amCnded. for the 

### pesticide regi!tered under EPA Reg. No. 

### "



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### " filename: TIlidiazuron·Diuron 4.SSC (xxx-Ol1607) 

# U330-36'; Page 1 , , 

### ,PRECAUTIONARY STATEMENTS HAZARDS TO HUMANS AND DOMESTIC ANIMALS CAUTION Harmful if swallowed. Causes moderate eye irritation. Avoid contact with eyes or clothing. Wash thoroughly with soap and water after handling and before eating, drinking, chewing gum, or using tobacco

..
PERSONAL PROTECTIVE EQUIPMENT Applicators and other handlers (other than mixers and loaders) must wear:

• Coveralls worn over long-sleeved shirt and long pants

• Chemical-resistant gloves, such as barrier laminate or butyl rubber gloves

• Chemical-resistant footwear plus socks

• Protective eyewear Mixers and loaders must wear:

• Coveralls worn over long-sleeved shirt and long pants

• Chemical-resistant gloves, such as barrier laminate or butyl rubber gloves

• Chemical-resistant footwear plus socks

• Protective eyewear 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 STATEMENT When handlers use closed systems, enclosed cabs, or aircraft in a manner that meets the requirements listed in the Worker Protection Standard (WPS) for agricultural pesticides 140 CFR 170.240 (d) (4-6)], the handler PPE requirements may be reduced or modified as specified in the WPS.

USER SAFETY RECOMMENDATIONS Users should:

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

• Remove clothing immediately if pesticide gets inside. Then wash thoroughly and put on clean clothing.

• Remove PPE immediately after handling this product. Wash the outside of gloves before removing. A$ soon as possible, wash thoroughlv and chanqe into clean clothing.

ENVIRONMENTAL HAZARDS 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 contaminate water by cleaning of equipment or disposal of equipment washwaters. Do not apply when weather conditions favor drift from treated areas.

GENERAL INFORMATION THIDIAZURON-DIURON 4.5SC is a harvest aid for cotton, used for leaf removal prior to harvest. THIDIAZURON-DIURON 4.5SC can be applied in most weather conditions, both warm and cool.

USE PRECAUTIONS This product is not to be applied through any type of irrigation system. Effectiveness of THIDIAZURON-DIURON 4.5SC will be reduced if rainfall occurs within 12 hours post application. Foliage from treated plants or gin trash is not to be fed to livestock.

Filename: Thidiazuron-Diuron 4.5SC (xxx-021607j 'I,,,,



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## "
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". > > > , , Page2**>~~**Rotation to the following crops requires the minimum specified periods below after the last application of THIDIAZURON-DIURON 4.5SC: small grains, sorghum, corn, or root crops (except carrots, onions)

................................. two (2) months legumes (including alfalfa) or leafy vegetable {except lettuce)

....................................... two (2) months cole crops, garlic, safflower, tomatoes, and watermelon

............................................... two (2) months carrots

........................................................................................................... three (3) months onions

.......................................................................................................... four (4) months cantaloupe, honeydew melon/casaba melon, muskmelon, or peppers

......................... five (5) months lettuce

........................ when soil has been deep-plowed (12-15 inches)

...................... two (2) months

OR lettuce

.......... when soil is only disced (4-6 inches)

........................ "

.......... nine (9) months All other crops

.............................................................................................. twelve (12) months
Special Note for inter-cropped grains and legumes planted either as cover crops or planted into treated fields before the minimum two (2) month plant back time after the final THIDIAZURON-DIURON 4.5SC application: Any such crops are prohibited for use as feed or food and may be used only as cover crops.

Immature crops should not be used for food or feed.

Prevent spray drift from contacting crops other than mature cotton, since this product may defoliate or injure other plant species.

Mixtures with organophosphates can increase nontarget crop phytotoxicity. Additional care should be exercised when lettuce, citrus, cantaloupes or any other edible crops are adjacent to THIDIAZURONDIURON 4.5SC treated cotton fields.

PROCEDURES TO LOWER SPRAY DRIFT POTENTIAL ONTO NONTARGET CROPS Under windy weather conditions, applications of THIDIAZURON-DIURON 4.5SC may drift to non-target crops. The following procedures can help reduce the potential for drift:

• If wind speeds top ten (10) miles per hour at the application site, do not make aerial or ground applications of THIDIAZURON-DIURON 4.5SC.

• Nozzle pressure of 20-30 psi is recommended.

• Do not apply this product during a temperature inversion because drift potential is high. In addition, do not apply this product 

### if the development of a temperature inversion appears likely during the application period.

• This product should not be applied by ground with'ln 100 feet or by ak within 0.5 mile of lettuce.

RIO GRANDE VALLEY OF TEXAS PROCEDURES TO LOWER SPRAY DRIFT POTENTIAL The following procedures can help reduce the potential for drift:

• If wind speeds top ten (10) miles per hour at the application site, do not make aerial or ground applications of THIDIAZURON-DIURON 4.5SC. If wind speeds are less than ten (10) miles per hour, observe local recommendations from your State Extension Cotton Specialist.

• Nozzle pressure of 20-30 psi is recommended.

• Do not apply this product during a temperature inversion because drjft potential is high. In addition, do not apply this product if the development of a temperature inversion appears likely during the application period.

• The maximum nozzle orifice size that provides proper coverage and deposition of this product should be used.

• CITRUS AREAS: This product should not be applied by ground within 0.5 mile or by air within 5 miles upwind of citrus in flush.

I'ilename: Thidiazuron-Diuron 4.5SC (xxx-021607) Page 3DIRECTIONS FOR USE 

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



### Do not make applications of this product that may contact workers or other person either by drift or directly. Protected handlers only are anowed in the area during application. Consult your State or Tribe agency responsible for pesticide regulations for any specific recommendation.

AGRICULTURAL USE REQUIREMENTS Use this product only in accordance with its labeling and with the Worker Protection Standard, 40 CFR Part 170. This Standard contains requirements for the protection of agricultural workers on farms, forests, nurseries, and greenhouses, and handlers of agricultural pesticides. It contains requirements for training, decontamination, notification, and emergency assistance. It also contains specific instructions and exceptions pertaining to the statement 0:1 this label about personal protective equipment (PPE), and restricted-entry inlervaL The requirements in 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 24 hours.

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 worn over long-sleeved shirt and long pants

• Chemical-resistant gloves such as barrier laminate or butyl rubber gloves

• Chemical-resistant footwear plus socks

• Protective evewear

TIME OF APPLICATION THIDIAZURON-DIURON 4.5SC defoliant applications are to be made only on mature cotton plants when the uppermost harvestable boll is mature. Boll maturity is defined as 1) when a boll is squeezed between thumb and finger, it does not dent; 2) when cutting a cross section with a sharp knife is difficult; 3) when seeds in cross section lack liquid wilhin the seed coat or outer edges of seed coat are light brown; and 4) when fully developed cotyledons are present.

Make applications of THID1AZURON-D1URON 4.5SC at least 5 days prior to expected harvest date.

NOTE: Adequate defoliation with THIDIAZURON-D1URON 4.5SC depends on three factors:

• Cotton is actively growing.

• High relative humidity.

• Cotton plant leaves are turgid and not desiccated.

ATTENTION: Desiccation and/or leaf freezing may occur during periods of high temperature when adjuvants are added to THIDIAZURON-DIURON 4.5SC application solution. Products and adjuvants known to cause desiccation of cotton leaf tissue should not be used.

Under low nighttime temperatures (below 

### 60°F) or otherwise adverse conditions, this product, when used alone, may provide less than expected defOliation and / or regrowth suppression.

Likewise, cotton that does not have a uniform boll load, has excessive vegetative growth and/or is being defoliated with less than 65% open boll then a tank mixture of adjuvants and other defoliant materials should be considered.

APPLICATION INFORMATION Use an adequate volume of water with the recommended amount of THIDIAZURON-DIURON 4.5SC defoliant to uniformly and completely cover leaves. For ground equipment, apply 

### to

- 25 galion per acre and by air, use 2 

### -10 gallons per acre. Maintain agitation during application.

Filename: Thidiuzurol1-DiurOI1 4.SSC (:\::\:x-021607) Page 4DOSAGE INFORMATION

In some situations, a follow-up application may be needed. THIDIAZURON-DIURON 4.5SC may be used for this application. Other defoliants may be needed. If additional boll opening is required, Ethephon 6 or 

### any other boll-opening products may be used at recommended rates; see product label for rates and timings. Consult your local State Extension Cotton Specialist recommendations for rates and timings.

The maximum annual use rate of THIDIAZURON-DIURON 4.5SC is 5.33 

### flo oz. (0.33 pints) per acre per


### season. MIXING INSTRUCTIONS 1. Fill 

### spray applicator tank with at least one half of the water to be used 

### 2. Start agitation 3. Add the appropriate volume of THIDIAZURON -DIURON 4.5SC 4. Continue agitation and fill tank with the remainder of the water to be used 5. Agitation should continue throughout the application

PRECONDITIONING When used as a pre-conditioner seven to ten days before application of this or other defoliant compounds, th'ls product will improve the efficacy of such a defoliant application. Before use, observe all product label directions, recommendations and prohibitions on both products' labels.

PRECONDITIONING APPLICATION RATE for THIDIAZURON DIU RON 4 SSC 

# . THIDIAZURON·DIURON 4.SSC One Gallon of Gallons of S ray Solution Formulated Product THIDIAZURON·DIURON 4.SSC Will Treat Air Ground 0.67 Flo Oz. 191 1.33 Flo Oz. 96 2·10 10·2S 2.00 Flo Oz. 48

STANDARD APPLICATION STANDARD APPLICATION RATE: Use 1.33-2 fl.oz. of this producUacre in an aerial application of 2-1 0 gallons of spray solution or ground application of 10-25 gallons of spray solution.

APPLICATION RATE TABLE for THIDIAZURON·DIURON 4 SSC



## . THIDIAZURON-DIURON 4.5SC One Gallon of Pounds Active Gallons of Spray Solution FOITIlulated Product THIDIAZURON- Ingredients DIURON 4.5SC per Acre

Will Treat Air Ground 0.67 fl. oz.lAcre 191 Acres 0.0235 (0.04 pUAere) 1.33 fl. oz./Acre 96 Acres 0.048 (0.08 pUAere) 2.13 

### fl. oz.lAcre 60 Acres 0.075 (0. 13.Jl!.IAere) 2-10 10·25 2.93 flo oz.lAcre 45 Acres 0.10

(0.18 pUAere) 4.27 

### fl. oz.lAcre 30 Acres

. 0.15 (0

.. 27 pUAere)

### ~C33 fl.

### OZ.lAe;~

0.33 pUAere 24 Acres 0.1875

RESTRICTIONS:

• Do not apply more than 0.33 pint of Thidiazuron-Diuron 4.5SC per acre per season.

• Do not exceed maximum label rate with split applications of Thidiazuron-Diuron 4.5SC.

Filename: Thidiazuron-DiurOIl 4.5SC (xxx-Oll 607) Page 5IMPORTANT CLEAN OUT INSTRUCTIONS When applying**THIDIAZURON~DIURON** 4.5SC, a residue may form in application equipment. This residue can best be flushed out of the spraying system by using a commercial tank cleaner when done while residue is still fresh and moist. DO NOT ALLOW EQUIPMENT TO DRY BEFORE CLEAN OUT. Consult your State Extension Cotton Specialist for recommended tank cleaners and cleaning procedures.



### Tank cleaner and water should be used immediately after application. The entire system including nozzles, booms, application tanks, sumps, pumps, and transfer lines should be flushed. Allowing the spray solution to dry in the application equipment can result in residues that are more difficult 

### to remove. Dried residues are extremely difficult to remove. To remove such dried residues, fill the affected equipment to capacity with commercial tank cleaner solution and let it remain for 7 days. Afterwards, the equipment will need to be thoroughly flushed and rinsed.

Spray application equipment that has been inadequately cleaned will contain residue of THIDIAZURON**~** DIURON 4.5SC. Such improper cleaning could lead to crop damage in later applications.
Arysta LifeScience North America Corporation assumes no liability due to equipment that has not been properly cleaned.

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

PESTICIDE STORAGE: Store this product in a cool, dry place in its original container only. Container should be closed when not in use. Do not expose the product to open flame excessive heat. Store in original container and keep closed.

PESTICIDE DISPOSAL: Pesticide wastes are acutely hazardous. Improper disposal of excess pesticide, spray 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 Control Agency, or the Hazardous Waste representative at the nearest EPA Regional Office for guidance.

To Contain a Spill: Absorb liquid by covering it with cat litter, commercial clay, lime, sand, sawdust, or soda ash. Once absorbed, bury the cleaning materials and cleanse the spill area with a detergent and water solution.

CONTAINER DISPOSAL: Triple rinse (or equivalent); then offer for recycl'lng or recondirloning, or puncture and dispose of in sanitary landfill, or by other procedures approved by State and local authorities.

DO NOT REUSE EMPTY CONTAINER

CONDITIONS OF SALE

1. It is impossible to eliminate all risks associated with the use of this product. Such risks may arise from weather conditions, soil factors, offAarget movement, unconventional fanning techniques, the presence of other materials, the manner of use or application, or other unknown factors, all of which are beyond the control of Arysta LifeScience North America Corporation ("Arysta"), and can cause crop injury, injury to**non~target** crops or plants, ineffectiveness of the product, or other unintended consequences. All such risks shall be assumed by the user or buyer. 2. Arysta warrants that this product conforms to the chemical description on the label and is reasonably 

### fiI for the purposes stated in the Directions for Use, subject to the inherent risks described above, when used in accordance with the Directions for Use under normal conditions. 3. This warranty does not extend to the use of this product contrary to label instructions or under conditions not reasonably foreseeable to Arysla, and is subject to the inherent risks described above. TO THE EXTENT CONSISTENT WITH APPLICABLE LAW, ARYSTA DISCLAIMS ALL OTHER WARRANTIES, EXPRESSED OR IMPLIED, INCLUDING ANY WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE. TO THE EXTENT CONSISTENT WITH APPLICABLE

filename: Thidiazuron-Diuron 4.5SC (xxx-021 (07) Page 6LAW, ARYSTA, MANUFACTURER, AND SELLER DISCLAIM AND SHALL NOT BE LIABLE FOR ANY SPECIAL, INCIDENTAL, INDIRECT, OR CONSEQUENTIAL DAMAGES RESULTING FROM THE USE, HANDLING, APPLICATION, STORAGE, OR DISPOSAL OF THIS PRODUCT OR FOR DAMAGES IN THE NATURE OF PENALTIES, AND THE USER AND BUYER WAIVE ANY RIGHT THAT THEY MAY HAVE TO SUCH DAMAGES. NO AGENT, REPRESENTATIVE OR EMPLOYEE OF ARYSTA IS AUTHORiZED TO MAKE ANY WARRANTY, GUARANTEE OR REPRESENTATION BEYOND THOSE CONTAINED HEREIN OR TO MODIFY THE WARRANTIES CONTAINED HEREIN. 4. TO THE EXTENT CONSISTENT WITH APPUCABLE LAW, THE EXCLUSIVE REMEDY OF THE USER OR BUYER, AND THE TOTAL LIABILITY OF ARYSTA, MANUFACTURER, AND SELLER, SHALL BE LIMITED TO THE PURCHASE PRICE PAID, OR AT ARYSTA'S ELECTION, THE REPLACEMENT OF THE PRODUCT.

Filename: Thidiazuron-Oiuron 4.5SC (xxx-021607j Page 7THIDIAZURON-DIURONSCCOTTONDEFOLIANTForAgriculturalUseOnlyACTIVEINGREDIENTS:111idiazur0I1:N-phenyl-N'-1,2,3-thidiazol-5-ylurea*...........................36.06%Dillron:3-(3,4-dichlorophenyl)-I,I-dtmetltylurea*............................18.04%OtherIltgredients:...................................................................45.90%TOTAL.....................................................................100%3lb.'ChidiazuronpergaOonandt.5th.DiurOIlpergaUonKEEPOUTOFREACHOFCHILDRENCAUfIONSilistednoentiendelaetiqueta,busqueaalguienparaqueselaexpliqueaustedendetalle.(Ifyondonotnnderstandthislabel,findsomeonetoexplainittoyouindelait.)FIRSTAIDIFSWALLOWEDImmediatelycallapoisoncontrolcenterordoctorfortreatmentadvice.Donotinducevomitmgunlesstoldtodosobyapoisoncontrolcenterordoctor.Havepersonsipaglassorwaterifabletoswallow.DonotgivebymoulhtoanunconsciouspersonIFINEYES:Holdeyeopenandrinseslowlyandgentlywithwaterfor15-20minutes.Removecontactlenses,ifpresent,afterthefirst5minutes,thencontinuermsing.CallapoisoncontrolcenterordoctorfortreatmentadviceNOTETOPHYSICIAN:Probablemucosaldamagemaycontraindicatetheuseof.astriclavageHOTLINENUMBERHavetheproductcontainerorlabelwithyouwhencallingapoisoncontrolcenterordoctororgoingfortreatment.EMERGENCYNUMBERS,•TransportatklltorspHl,callCHE!>4TREC800-424-9300.•Humanhealth,800-832-HELP(4357).•Animalhealth,callASPCAat800-345-4735SF.EAITACtlEDBOOKLETFORADDITIONALPRECAUTtONSANDUSEDIRECTIONSFilcl1ol\lc:ThidiaZllrol1-Diuroll4.5SCIxxx-02(607)PRECAUTIONARYSTATEMENTSHAZARDSTOHUMANSANDDOMESTICANIMALSCAUTIONHannfulifswallowed.Causesmoderateeyeirritation.Avoidcontactwitheyesorclothing.Washthoroughlywithsoapandwaterafterhandlingandbeforeeating,drinking,chewinggum,orusingtobacco..ENVIRONMENTALHAZARDSDonotapplydirectlytowater,ortoareaswheresurfacewaterispresent,ortointertidalareasbelowthemeanhighwatermark.Donotcontaminatewaterbycleaningofequipmentordisposalofequipmentwashwaters.Donotapplywhenweatherconditionsfavordriftfromtreatedareas.DIRECfIONSFORUSEItisaviolationofFederallawtousethisproductinamannerinconsistentwithitslabeling.Donotmakeapplicationsofthisproductthatmaycontactworkersorotherpersoneitherbydriftordirectly.Protectedhandlersonlyareallowedinthellreaduringapplication.ConsultyourStateorTribeagencyresponsibleforpesticideregulationsforanyspecificrecommendation.STORAGEANDDISPOSALDonotcontaminatewater,food,orfeedbystorageordisposal.PESTICIDESTORAGE:Storethisproductinacool,dryplaceinitsoriginalcontaineronly.Containershouldbeclosedwhcnnotinuse.Donotexposetheproducttoopenflameexcessiveheat.Storeinoriginalcontainerandkeepclosed.PESTICIDEDISPOSAL:Pesticidewastesareacutelyhazardous.Improperdisposalofexccsspesticide,spraymixture,orrinsateisaviolationofFederallaw.Ifthesewastescannotbedisposedofbyuseaccordingtolabelinstructions,contactyourStatePesticideorEnvironmentalControlAgency,ortheHazardousWasterepresentativeatthenearestEPARegionalOfficeforguidance.ToContainaSpill:Absorbliquidbycoveringitwithcatlitter,commercialclay,lime,sand,sawdust,orsodaash.Onceabsorbed,burytheclcaningmaterialsandcleansethespillareawithadetergentandwatersolution.CONTAINERDISPOSAL:Triplerinse(orequivalent);thenofferforrecyclingorreconditioning,orpunctureanddisposeofinsanitarylandfill,orbyotherproceduresapprovedbyStateandlocalauthorities.DONOTREUSEEMPTYCONTAINEREPAReg.No.663JO-xxxEPAEst.No.51036-GA-00IADxxxxxNETCONTENTS,___Page8ManufacturedbyArystaLifeScienceNorthAmericaCorporation15401WestonParkway,Suite150Cary,NC27513UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D.C. 20460



## Mr. Bill Washburn Regulatory Affairs Manager 

### 3 1 AUG 3J07 OFRCEOF PREVENTION, PESTIC!DES AND TOXIC SUBSTANCES



## Arysta LifeS.cience North America Corporation 15401 Weston Parkway, Suite 150 Cary, NC 27513

Dear 

## Mr. Washburn:

Subject: Thiadazuron-Diuron 4.5SC EPA File Symbol No. 66330-GAU Submission dated February 28, 2007



## The application referred to above has been detennined, pursuant to 40 CFR 152.105, not to be sufficiently complete to process; therefore, the application is considered deficient. Labeling! other information as specified below must be submitted before the processing of the 

## application

can be completed. If such deficiencies cannot be corrected within 75 days, you must notify the Agency within those 75 days of the date you expect to complete the application. If, after 75 days, 

## you do not respond, or your subsequently fail to complete the application within the scheduled times of completion, the Agency will terminate any action on the application, an<;i will treat the application as if it 

## has been withdrawn by the applicant. Any subsequent submission relating to the application must be submitted as a new application.

I. 

### The submitted acute oral toxicity study (870.1100, MRID 1147070603) is 

## unacceptable, due to a laboratory error in recording results. This study must be repaired, or an acceptable repeat study submitted, 

## in order to detennine the appropriate precautionary 

## label language for this product. Please see the attached acute toxicity review for more details.

If you have any questions, please contact Kathryn Montague at 703-305-1243.



## Sincerely,

# ~lle~-~ Product Manager 23 

## Herbicide Branch Registration Division (7505P)PC Code 035505, 120301 EPA RegJFile Symbol No. 66330-GAU



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



### 21/AUG/2007

MEMORANDUM OFFICE OF PREVENTION, PESTICIDES AND TOXIC SUBSTANCES



### Subject: 

## Name of Pesticide 

## Product: Thidiazuron

- Diuron 4.55C EPA Reg. No. !File Symbol: 66330-GAU



## From:

To:

Applicant: DP Barcode: D338292 Decision No.: 376316 PC Codes: 035505, 120301 Action Code: R31


## Eugenia Mc Andrew, Biologist Technical Review Branch Registration Division (7505P)

Kathryn Montague, RM Team 23 

## Herbicide Bran.ch Registration Division (7505P)


## Arysta LifeScience North America Corporation 15401 Weston Parkway, suite 150 Cary, NC 27513

FORMULATION FROM LABEL:

Active Ingredient(sl: 120301 Tbidiazuron 035505 Diuron

Inert Ingredient(s):

ACTION REQUESTED: The Risk Manager requests:



## Please revi ew acute tox studies for this new product registration. %bywt. 

### 36.06 18.Q4

45.90 Total: 100.00%PC Code 035505, 120301 EPA RegJFile Symbol No. 66330·GAU



### BACKGROUND: Arysta LifeScience North America Corporation has submitted a six pack of 

## acute toxicity studies to support the registration of the 

## proposed product, Thidiazuron

- Dimon 4.55C,EPA File Symbol 66330-GAU. The studies were conducted at Product Safety 

## Laboratories, Dayton, New Jersey with assigned MRID numbers 470706-03 to -08. A CSF dated February 27, 2007 for a basic formulation is included in the submission.

RECOMMENDATIONS:



## The acute dermal, acute inhalation, primary eye irritation, primary skin irritation and dermal sensitization studies have been reviewed and are classified as acceptable.

The acute oral toxicity study is classified as unacceptable. TRB discussed this study on August 7,2007 with the Study Director, George Moore. TRB detected that an error was made by the laboratory when the results of the eighth dose of the Main Study were recorded. The result of this



## error was that the stopping criteria of the 

## UDP test were not met and therefore, an LD50 value

was not determined. During this phone call options for salvaging the study were discussed with G. Moore. TRB gave the option to the laboratory to plot the results using the Probit method with the existing animals and to email the results to TRB. Again on August 14, the study director was contacted and a voice mail 

## message was left. To date, TRB has not yet received an answer. Therefore, the acute oral toxicity study is a data gap.

The acute toxicity profile for Cherninova Nicosulfuron Technical, EPA File Symbol 66330- 

## GAU, is as follows:

Acute oral toxicity Acute dermal toxicity Acute inhalation toxicity Primary eye initation Primary skin initation Dermal sensitization data gap 

### N N 

### IV N 

### Neg. Unacceptable MRID 47070603 Acceptable MRID 47070604 Acceptable MRID 47070605 Acceptable MRID 47070606 Acceptable MRID 47070607 Acceptable MRID 47070608

LABELING: The precautionary labeling language cannot be determined at this time due to the data gap in the acute oral toxicity study.

2

### ( PC Code 

## 035505, 120301 EPA Reg./File Symbol No. 66330-GAU


## Reviewer: Eugenia McAndrew Risk Manager: 23 Date: August 21,2007

STUDY TYPE: Acute Oral Toxicity

- Rat; OPPTS 870.1100; OECD 425

TEST MATERIAL: Thidiazuron-Diuron 4.5SC (Lot 

### # 06-102-0 I; 36% Thidiazuron and 18.0% Diuron; off- white liquid; pH

- 5.5)

CITATION: Moore, G. (2006) Acute Oral Toxicity Up and Down Procedure 

### in Rats. Product Safety Laboratories, Dayton, New Jersey. Laboratory Study Number 19603. August 30, 2006. MRlD 47070603 Unpublished.

SPONSOR: Micro Flo Company, 14284 Higbway 41 North, Sparks, GA 31647

EXECUTIVE SUMMARY: In 

### an acute oral toxicity study (MRID 47070603), twelve female 

## Sprague-Dawley derived young adult albino rats (age: 9-10 weeks; source: Ace Animals, Il).c., Boyertown, PA; 184-214 g) were given a single oral dose of Thidiazuron-Diuron 4.5SC (Lot 

### # 06-102-01; 36% Thidiazuron and 18.0% Diuron; off- white liquid; pH

- 5.5) using the Up and 

## Down Procedure. A limit dose of 5000 

## mglkg of the 

## test substance was administered to four healthy female rats by oral 

## gavage. Due to the mortality of three of these 

## animals, a Main Test

was conducted. Using a default starting dose of 175 mgikg, eigbt edditional animals were dosed at 175, 550, 1750 or 5000 mgikg. Auimals were then observed for 14 days.



### TRB 

## detected that an error was made by the laboratory when the results of the 

## eighth dose of the 

## Main Study were recorded. The result oftbis error was that the stopping criteria of the 

## UDP test

were not met and therefore, an LD50 value was not determined.

At the 175 

## and 550 

## mglkg dose levels, the three animals survived and gained weight. No clinical signs were noted. No gross abnormalities were noted at necropsy. At the 1750 

## mglkg dose level,

one female died within one day of test 

## substance administration. This animal was hypoactive prior to death. The surviving anim;.tls exhibited hypoactivity, reduced fecal volume and/or piloerection but recovered by day 2 and gained weigbt. Gross n,ecropsy of the decedent revealed 

## red intestines. No gross abnormalities were noted for the animals surviving to study termination. At the 5000 mgikg dose level, four of six animals died within one day oftest substance 

## administration. Prior to death these animals were hypoactive and exhibited hunched posture, piloerection and/or shallow respiration. The surviving animals exhibited hypo activity, 

## reduced fecal volume and/or soft feces but recovered by day 5 and gained weight. Gross necropsy of the 

## decedent revealed discoloration of the 

## intestines. No gross abnormalities were noted for the anim3J.s surviving to study termination.

This acute oral study is classified as unacceptable. It 

## does not satisfy the guideline requirement for an acute oral study (OPPTS 870.1100; OECD 425) in the rat.

COMPLIANCE: Sigued and dated GLP, Quality Assurance, and Data Confidentiality 

## statements were provided.

3PC Code 035505, 120301 EPA RegJFue Symbol No. 66330-GAU



### RESULTS and DISCUSSION:



## Individual animals were dosed as follows:

Limit Test Dosing Animal No. 

## Dose level Short Term 

## 14 Day Outcome 

## Sequence (mglkg) 

## Outcome



## 1 9866 5000 S S



## 2 9900 5000 D D

3 9901 5000 D D

4 9919 5000 D D

Main Test 

## Dosing Animal No. 

## Dose level Short Term 

## 14 Day Outcome Sequence (mglkg) 

## Outcome



## 1 9934 175 S S


## 2 9956 550 S S


## 3 9958 1750 S S


## 4 9962 5000 S 

### S


## 5 9965 5000 X X



## 6 9976 1750 X



## . X



## 7 9981 550 S 

### S



## 8 9987 1750 SI SI

S = 

### survival 

### D = 

### death

I 

## Due to an error, this dose was recorded as a death and the study was stopped before the stopping criteria of the 

## UDP program were met. The study director confirmed the error on August 

## 7, 2007. Statistical Analysis**~** 

### The Acute Oral Toxicity (Guideline 

## 425) Statistical Program 

## (Westat, version 1.0, May 2001) was used for all data analyses including: dose progression selections, stopping criteria detenninations and/or LDso and confidence limit calculations.

4PC Code 035505, 120301 EPA RegJFile Symbol No. 66330·GAU



### A. Mortality· As noted in the tables.

B. Clinical observations· At the 175 and 550 mglkg dose levels, the three animals survived and gained weight. No clinical signs were noted. No gross abnormalities were noted at necropsy. At the 1750 mglkg dose level, one female died within one day of test substance administration. This animal was hypoactive prior to 

### death. The surviving animals exhibited hypoactivity, reduced fecal volume and/or piloerection but recovered by day 2 and gained weight. At the 5000 mglkg dose level, four of six animals died within one day of test substance administration. Prior to death these animals were hypoactive and exhibited hunched posture, piloerection and/oJ.' shallow respiration. The surviving animals exhibited hypoactivity, reduced fecal volume and/or soft feces but recovered by day 5 and gained weight.

C. Gross Necropsy

- No gross abnormalities were noted for any of the animals surviving to study tennination. Gross necropsy of the decedents revealed' discoloration of the intestines.

D. Reviewer's Conclusions! TRB detected that an error was made by the laboratory when the res:ults of the eighth dose of the Main Study were recorded. The result of this error was that the stopping criteria of the UDP test were not met and therefore an LDso value was not determined. The study is therefore classified as unacceptable.

AOT425statpgm (Version: 1.0) Test Results and Recommendations Acute Oral Toxicity (OEep Test Guideline 425) Statistical Program

Date/Time: Tuesday, August 07, 2007, '1:43:52 PM Data file name: thidiazuron-diuron main.dat Last modified: 8/7/2007 1:43:54 PM

Test/Substance: Thidiazuron-diuron

. Test type: Main Test Limit dose (mg/kg): 5000 Assumed.LD50 (mg/kg): Default Assumed sigma (mg/kg): 0.5

Recommended dose progression: 5000, 1750, 550, 175, 55, 17.5, 5.5, 1.75

5PC Code 035505,120301 EPA RegJFile Symbol No. 66330-GAU



### DATA:

Test Animal Dose Short-term Long-term Seq. ID (mg/kg) 

### Result Result

1 

### 9934 175 0 0 2 

### 9956 550 0 0 3 

### 9958 1750 0 0 4 

### 9962 5000 0 0 5 

### 9965 5000 X 

### x 6 

### 9976 1750 

### x X 7 

### 9981 550 0 0 8 

### 9987 1750 0 0


### (X = 

### Died, 0**~** 

### Survived)



### Dose Recommendation: Dose the next**an~l** 

### at 5000 mg/kg. Laborat'ory failed to record "short term live" and instead recorded.**~'death"** 

### for dose 8.

SUMMARY OF LONG-TERM RESULTS:

Dose 0 X 

### Total

175 1 0 1 550 2 0 2 

### 1750 2 1 3 

### 5000 1 1 2



### All Doses 6 2 8

6PC Code 035505, 120301 EPA RegJFile Symbol No. 66330..(;AU


## Reviewer: Eugenia McAndrew Risk Manager: 23 Date: August 21, 2007

STUDY TYPE: Acute Dennal Toxicity

- Rat; OPPTS 870.1200; OECD 402

TEST MATERIAL: Thidiazuron-Diuron 4.5SC (Lot # 06-102-01; 36% Thidiazuron and 18.0% Diuron; off- white liquid; pH

- 5.5)

CITATION: Moore, G. (2006) Acute Dennal Toxicity Study in Rats

- Limit Test. Product Safety Laboratories, Dayton; New Jersey. Laboratory Study Number 19604. September 15, 2006. MRID 47070604 Unpublished.

SPONSOR: Micro Flo Company, 14284 Highway 41 North, Sparks, GA 31647

EXECUTIVE SUMMARY: In an acute dennal toxicity study (MRID 47070604), 5/sex of Sprague-Dawley derived young adult albino rats (age: 10-11 weeks; source: Ace Animals, lnc., Boyertown, P M;3j9-412 g males and 241-249 g females) were dennally exposed to Thidiazuron-DM'ron 4.5SC (Lot 

### # 06-102-01; 36% Thidiazuron and 18.0% Diuron; off- white liquid; pH

- 5.5). Five thousand mglkg of body weight of the test substance was applied to a dose



## area of approximately 2 inches x 3 inches (approximately 10% of the body surface) and covered with a gauze pad. The gauze pad and entire 

## trunk of each animal were Wrapped with tape for a 24 hour period. After 24 hours the pads were removed and the sites were cleansed. Animals were then observed for 14 days.

Dermal LDso Males 

## > 5000 mglkg bw Dermal LDso Females 

## > 5000 mglkg bw Dennal LDso Combined > 

### 5000 mglkg bw

All animals survived. Two males lost weight during the first week of the study but all animals 

## gained weight by study termination. "There were no signs of gross toxicity, dennal irritation, adverse phannacologic effects or abnonnal behavior." No gross abnonnalities were noted at necropsy.
Toxicity based on no deaths at the limit dose. EPA Toxicity Category IV.



## 1bis acute dennal study is classified Acceptable. It 

## does satisfy the guideline requirement for an acute dermal study (OPPTS 870.1200; OECD 402) in the rat.

COMPLIANCE: Sigued and dated GLP, Quality Assurance, and Data Confidentiality 

## statements were provided.

7PC Code 035505, 120301 EPA RegJFile Symbol No. 66330-GAU


### RESULTS and DISCUSSION:

MortalitvlNumber Tested I)Qse (mglkg 

### bw) Males Females Combined

5000 

### 015 015 0110

A. Mortality

- None

B. Clinical observations

- All animals survived. Two males lost weight during the first week of the study but all animals gained weight by study termination. "There were no signs of gross toxicity, dermal irritation, adverse pharmacologic effects or abnonnal behavior."

C. Gross Necropsy

- No gross abnormalities were noted.

D. Reviewer's Conclusions: TRB agrees with the study author that the acute dermal LDso of Thidiazuron-Diuron 

### 4.5SC is greater thao 5000 mglkg 

### bw in male aod female rats.

8

### )

PC Code 035505, 120301 EPA RegJFile Symbol No. 66330..(;AU


## Reviewer: Eugenia McAndrew Risk Manager: 23 

### Date: August 21,2007

STUDY TYPE: Acute Inhalation Toxicity

- Rat; OPPTS 870.1300; OECD 403

TEST MATERIAL: Thidiazuron-Diuron 4.5SC (Lot # 06-102-01; 36% Thidiazuron and 18.0% Diuron; off- white liquid; pH

- 5.5)

CITATION: Moore, G. (2006) Acute Inhalation Toxicity Study in Rats

- Limit Test. Product Safety Laboratories, Dayton, New Jersey. Laboratory Study Number 19605. September 15, 2006. MRID 47070605 Unpublished.

SPONSOR: Micro Flo Company, 14284 Highway 41 North, Sparks, GA 31647

EXECUTIVE SUMMARY: In 

### an acute inhalation toxicity study (MRlD 47070605), 51Sex of 

## young 

## adult Sprague-Dawley derived albino rats (age: 10-11 weeks; source: Ace Animals, Inc., Boyertown, PA; 301-361 g males and 228-249 g females) were exposed (whole body) via the inhalation route to Thidiazuron-Diuron 4.5SC (Lot 

### # 06-102-01; 36% Thidiazuron and 18.0% 

## Diuron; off- white liquid; pH

- 5.5) for 4 hours at a concentration of2.03 mglL. Animals were then observed for 14 days.

LCso Males> 2.03 mglL LC" Females> 2.03 mglL LCso Combined> 2.03 mgIL



## All animals survived and gained weight. In-chamber observations included hunched posture and hypoactivity. All animals recovered from these symptoms upon removal from the exposure chamber. No other clinical signs were observed. No gross abnormalities were noted at necropsy. The gravimetric chamber concentration was 2.03 mglL and the mass median aerodynamic diameter was estimated to be 3.7**~** 

## with a geometric standard deviation of2.13.
Toxicity is based on no deaths at the limit dose. EPAToxicity Category **N.**



## This acute inhalation study is classified as Acceptable. It 

## does satisfy the guideline requirement for an acute inhalation study (OPPTS 870.1300; DECD 403) in 

### the rat.

COMPLIANCE: Sigued and dated GLP, QUality Assurance, and Data Confidentiality 

## statements were provided.

9PC Code 035505, 120301 EPA Reg.lFile Symbol No. 66330-GAU



### RESULTS and DISCUSSION:

Gravimetric MortalitylNumber Tested 

### Nominal Cone. 

### MMAD 

## GSD Cone. (mgIL) (mgIL) 

### I'm Males Females Combined



### 125.10 2.03 3.7 2.13 0/5 0/5 0110

Test Atmosphere / Chamber Description:

Chamber Volume: 

### 150 L AirFlow: 

### 50.7 LPM Temperature: 

### 22-23°C Relative Humidity: 

### 60-80% Time to Equilibrium**T99~** 

### 13.6 min.

Test atmosphere concentration

- Gravimetric samples were withdrawn at 6 intervals from the breathing zone of the animals. Filter papers were weighed before and after collection to 

### detennine the chamber concentration. This value was divided by the total volume of air sampled
to detennine the chamber concentration.

Particle size determination

- Particle size was determined twice during the exposure. The MMAD and geometric standard deviation were detennined graphically using the two-cycle logarithmic probit axes.

A. Mortality

- None

B. Clinical observations

- All animals gained weight. In-chamber observations included hunched posture and hypoactivity. All animals recovered from these symptoms upon removal from the exposure chamber. No other clinical signs were observed.

C. Gross Necropsy

- No gross abnonnalities were noted.

D. Reviewer's Conclusions: TRB agrees with the study author that the acute inhalation 

### Le 5 0 

### ofThidiazuron-Diuron 4.5SC 

### is greater than 2.03 mg'L in male and female rats.

10pC Code 035505, 120301 EPA RegJFile Symbol No. 66330-GAU


## Reviewer: Eugenia McAndrew Risk Manager: 23 Date: August 21,2007

STUDY TYPE: Primary Eye Irritation

- Rabbit; OPPTS 870.2400; OECD 405

TEST MATERIAL: Thidiazuron-Diuron 4.5SC (Lot # 06-102-01; 36% Thidiazuron and 18.0% 

## Diuron; off- white liquid; pH

- 5.5)

CITATION: Moore, G. (2006) Primary Eye Irritation Study in Rabbits. Product Safety Laboratories, Dayton, New Jersey. Laboratory Study Number 19606. September 15, 2006. MRID 47070606 Unpublished.

SPONSOR: Micro Flo CoIl)pany, 14284 Highway 41 North, Sparks, GA 31647

EXECUTIVE SUMMARY: 

### In a primary eye irritation study (MRID 47070606), 0.1 mL of Thidiazuron-Diuron 4.5SC (Lot # 06-102-01; 36% Thidiazuron and 18.0% Diuron; off- white 

## liquid; pH

- 5.5) was instilled into the conjunctival sac of the 

## right eye of three 

## young adult New Zealand albino rabbits (1 male and 2 females; source: Robinson Services, Inc., Clemmons, NC). The left eye served as the control. Prior to instillation, two drops of ocUlar anesthetic (Tetracaine Hydrochloride Ophthalmic Solution, 0.5%) were placed into both the treated and control eye of 

## each animal. Animals were then observed at 1, 24, 48, and 72 hours post-instillation. Irritation

was scored by the method ofDraize.

A positive score was noted for conjunctivitis in all three eyes at the one hour observation. No positive scores were noted at 24 hours though a score of 1 was noted for conjunctivitis. All eyes
were free of irritation by 48 hours.

In this study, the fonnulation is minimally irritating to the eye. EPA Toxicity Category 

## N.

This study is classified as Acceptable. It 

## does satisfy the guideline requirement for a primary eye irritation study (OPPTS 870.2400; OECD 405) in the rabbit.

COMPLIANCE: Sigued and 

### dated GLP, Quality Assurance, and Data Confidentiality 

## statements were provided.

11PC Code 035505, 120301 EPA RegJFiJe Symbol No.**66330~GAU** 

### RESULTS AND DISCUSSION:



### Number "positive"/number tested

Observations Hours



## 1 24 48 72



### Corneal Opacity 

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

Iritis 

## 0/3 0/3 0/3 0/3 Conjrulctivitis*

Redness* 

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

Chemosis* 

## 0/3 0/3 0/3 0/3 Discharge* 

## 1/3 0/3 0/3 0/3

*Score of 2 or more required to be considered "positive."



### A. Observations - A positive score was noted for conjrulctivitis in all three eyes at the one hour observation. No positive scores were noted at 24 hours though a score of I was noted for conjunctivitis. All eyes were free of irritation by 48 hours.

B. Reviewer's Conclusions: TRB agrees with the study author that Thidiazuron-Diuron 4.SSC is minimally irritating to the eye.

12PC Code 035505, 120301 EPA RegJFile Symbol No. 66330-GAU



### Reviewer: Eugenia McAndrew Risk Manager: 23 Date: August 21, 2007

STUDY TYPE: Primary Dermal Irritation

- Rabbit; OPPTS 870.2500; OECD 404

TEST MATERIAL: Tbidiazuron-Diuron 4.5SC (Lot # 

### 06-102-01; 36% Tbidiazuron and 18.0% Diuron; off- white liquid; 

### pH

- 5.5)

CITATION: Moore, G. (2006) Primary Skin Irritation Study in Rabbits. Product Safety Laboratories, Dayton, New Jersey. Laboratory Study Number 19607. September 15,**2006~** 

### MRID 47070607 Unpublished.

SPONSOR: Micro Flo Company, 14284 Highway 41 North, Sparks, GA 31647

EXECUTIVE SUMMARY: In a primary dermal irritation study (MRID 47070607), three female young adult New Zealand albino rabbits (source: Robinson Services, Clemmons, NC)

were dermally exposed to Tbidiazuron-Diuron 4.5SC (Lot 

### # 06-102-01; 36% Tbidiazuron and 

## 18.0% Diuron; off- white liquid; pH

- 5.5). Five-tenths 

## of milliliter of the test substance was applied to one 6 cm 2 

## site on the dorsal area of each animal. Test sites were covered with a gauze pad. The pad and entire trunk 

## of each 

## animal were mapped with semi-occlusive tape. After a period of four hours, the pads were removed and the sites were cleansed. Animals were then observed at 1,24,48 and 72 hours after pad removal. Irritation was scored by 

### the 

## method of Draize.



### Primary Dermal Irritation Index (PDII)**~** 

### 1.3 Well defined erythema and vary slight to slight 

## edema were noted 

## -at all 

## three test sites one hour after patch removal. The irritation decreased with time. All sites were free of dermal irritation by 48 hours.

In this study, formulation is slightly irritating. EPA Toxicity Category IV.



## This study is classified as Acceptable. It 

## does satisfy the guideline requirement for a primary dermal irritation study (OPPTS 8702500; OECD 404) in the rabbit.

COMPLIANCE: Sigued and dated GLP, Quality Assurance, and Data Confidentiality 

## statements were provided.

13

# )

PC Code 035505, 120301 EPA RegJFile Symbol No. 66330-GAU



### RESULTS and DISCUSSION:

INDIVIDUAL SKIN IRRITATION SCORES

ERYTHEMAIEDEMA



### Hours After Patch Removal

Animal No. Sex 

## 1 

## 24 48 

### 72

3501 

### F 2/2 

### III 

## 010 010

3502 

### F 211 

## 1/0 010 010

3503 

### F 2/2 

### III 

## 010 010

A. Observations

- Well defined erythema and very slight to slight edema were noted at all three test sites one hour after patch removal. The initation decreased with time. All sites were free of derma! initation by 48 hours.

B. Results

- Primary Denna! Irritation Index (pDIl)**~** 

### 1.3



### C. Reviewer's Conclusions: TRB agrees 

## with the study author that Thidiazuron-Diuron 4.5SC is slightly initating to 

### the skin.

14PC Code 035505, 120301 EPA Reg./File Symbol No. 66330-GAU


## Reviewer: Eugenia,McAndrew Risk Manager: 23 Date: August 21, 2007

STUDY TYPE: Donnal Sensitization

- Guinea Pig; OPPTS 870.2600; OECD 406

TEST MATERIAL: Thidiazuron-Diuron 4.5SC (Lot # 06-102-01; 36% Thidiazuron and 18.0% Diuron; off- white liquid; pH

- 5.5)

CITATION: Moore, G. (2006) Donnal Sensitization Study in Guinea Pigs (Buehler Method). Product Safety Laboratories, Dayton, New Jersey. Laboratory Study Number 19608. September 15,2006. MRID 47070608 Unpublished.

SPONSOR: Micro Flo Company, 14284 Highway 41 North, Sparks, GA 31647

EXECUTIVE SUMMARY: In 

### a dermal sensitization study (MRID 47070608) with Thidiazuron-Diuron 4.5SC (Lot # 06-102-01; 36% Thidiazuron and 18.0% Diuron; off- white liquid; pH

- 5.5), 30 Hartley albino male guinea pigs (source: Elm Hill Breeding Labs, Chelmsford, MA; 329-397 g) were tested using the Buehler method. The procedures were validated using alpha-Hexy1cinnamaldehyde (HCA) in PSL study #18927 as the positive control 

## substance.

Once each week for three weeks, 0.4 mL 

## oftlie undiluted test substance was topically applied to the left side of20 test animals for a 6-hour exposure period for a total of three 

## exposures. Readings were made 24 and 48 hours after each induction application. The 

## animals were left untreated for two weeks. Twenty-seven days after the first induction dose, 0.4 rnL of the 

## undiluted test substance (the highest non-irritating concentration) was applied to a naive site on each test animal for a. 6-hour challenge exposure. Readings were made at 24 and 48 hours after 

## the exposure period. Ten naive control guinea pigs were treated with the undiluted test substance at challenge only. Readings were made at 24 and 48 hours after the exposure period.

In 

## this study, the formulation is not a dermal sensitizer.

Very faint erythema (0.5) was noted at 19/20 

### test animal sites during the induction phase. Following the challenge, very faint erythema (0.5) was observed at 9/20 

### test animal sites at 24 hours persistiug at three sites at 48 hours. In 

### the naive control group, very faint erythema (0.5)
was 

## noted at 5110 sites at 24 hourS only. No positive responses were noted 

## in either the 

## test or naive control animals.

This study is classified as Acceptable. 

### It does satisfy the guideline requirement for a dermal sensitization study (OPPTS 870.2600; OECD 406) in the Guinea pig.

COMPLIANCE: Signed and dated GLP, Quality Assurance, and Data Confidentiality 

## statements were provided. '

15PC Code 035505, 120301 EPA Reg./File Symbol No. 66330-GAU



### I. PROCEDURE

A. Induction**~** 

### Once each week for three weeks, 0.4 roL of the undiluted test substance was topically applied to the lett side of20 test animals for a 6·hour exposure period for a total of three exposures. Readings were made 24 and 48 hours after each induction. The animals were left untreated for two weeks.

B. Challenge**~** 

### Twenty-seven 

### days after the first induction dose, 0.4 mL of the undiluted test substance (the highest non-irritating concentration) was applied to a naive site on each test animal for a**6~hour** 

### challenge exposure. Readings were made at 24 and 48 hours after the exposure period.

C. Naive Controls**~** 

### Ten naive control guinea pigs were treated with the undiluted test substance (the highest**non~irritating** 

### concentration) at challenge only.

II. RESULTS and DISCUSSION:

A. Reactions and duration

- Very faint erythema (0.5) was noted at 19120 test animal sites during the induction phase. Following the challenge, very faint erythema (0.5) was observed at 9/20 test animal sites at 24 hours persisting at three sites at 48 hours. In the naive control group, very faint erythema (0.5) was noted at 

### 5110 sites at 24 hours only. No positive responses were noted in either the test or naive control animals.

B. Positive control**~** 

### The positive results of the RCA study#18927 validate the test system used in this study.

C. Reviewer's Conclusions: TRB agrees with the study author that based on the findings and evaluation system used, Thidiazuron-Diuron 4.5SC is not considered to be a contact sensitizer.PC Code 035505, 120301 EPA RegJFile Symbol No. 66330-GAU



### ACUTE TOX ONE-LINERS

1. DP BARCODE: 0338292 2. PC CODES: 035505, 120301 3. CURRENT DATE 2!1AUG/2007 

### 4. TEST MATERIAL: Thidiazuron-Diuron 4.5SC (Lot # 

### 06-102-01; 36% Thidiazuron and 18.0% Diuron; off- white liquid; pH

- 5.5)

Study/SpecieslLab 

## Tox. Core Study # !Date 

## MRID Results Cat. 

## Grade

Acute oral toxicity **1** 

## rat 47070603 LDso could not be Data U


### Product Safety Lab 

## determined because gap 

## stopping criteria were not 19603/8-30-06 

### met.


## Acute dennal toxicity **1** 

## rat 47070604 LDso> 5000 mg/kg IV 

### A
Product Safety Lab (males and females)
19604/9-15-06


### Acute inhalation toxicity 1 

### rat 47070605 LC so > 2.03 mg/L IV 

### A
Product Safety Lab (males and females)
1960519-15-06 

## Primary eye irritation **1** 

## rabbit 47070606 

## Conjunctivitis in **3/3** 

## eyes at IV 

### A
Product Safety Lab 

## one hour. No positive scores at 24 hours. All eyes free of 19606/9-15-06 

## irritation by 48 hours. Primary dermal irritation **1** 

## rabbit 47070607 PDII**~** 

### 1.3 

### Wen defined IV 

### A
Product Safety Lab erythema and very slight to 

## slight edema at **3/3** 

## sites at 19607/9-15-06 

## one hour. All sites free of irritation by 48 hours.



## Dermal sensitization **1** 

## guinea pig 47070608 

## Not a sensitizer



# -- A
Product Safety Lab
19608/9-15-06



## Core Grade Key: A =Acceptable, S = Supplementary, U = 

## Unacceptable, W = 

## Waived

Page 17 of 17SUBJECT:

FRDM:

TD: 

# FEE:

DATE DUT: 27 July 2007

PRDDUCT CHEMISTRY REVIEW MP[] EP[x] DP BARCDDE No.: Reg. File Symbol PRODUCT i 

### COMPANY: Arysta Lifescience North America Corporation 

### Decision No.: 376316 PC CODE: 035505.120301 FOOD -USE: 

## I x] Integrated Formulation 

## I ]

Bruce F. Kitchens, Chemist Technical Review Branch Registration Division (7505P)

# ~~

RM #23, 

### Joanne Miller/Kathryn Montague 

### Herbicide Branch (7505P) Registration Division (7505P) 

# 02.1!f4 2==;'

# ~ '::J-'3k 

# q

INTRDDUCTIDN:



### The registrant, Arysta Ufescience North America Corporation, is submitting an application to register the proposed end-use product, Thidiazuron-Diuron 4.5SC. The active ingredients in 1his product are Diuron and Thidiazuron at label nominal concentrations of 

### 18.04 and 36.06% a.i., respectively. This product is intended for use as a food use herbicide. In support of this request, the registrant has submitted a basic Confidential Statement of Formula (CSF) dated 27 Feb 2007,

a draft label, and product chemistry data contained in MRID#s 470706·01 and 470765·01. The Technical Review Branch (TRB) has been asked to review this submission.

SUMMARY OF FINDINGS

TRS has reviewed this submission and reports the following findings:

1. This product is produced from registered sources of the active ingredient.

2. All inert ingredients are cleared for use in formulated pesticide products. In addition, all inert ingredients are exempt from1he requirement of a food tolerance.

3. The nominal concentrations of the active ingredients listed on the proposed CSF and the draft label are the same.

4. The draft label contains the appropriate storage and disposal statements.

5. The active ingredients' certified Ii.mits as proposed on the basic CSF are acceptable.CONCLUSIONS:

TRB has reviewed this submission and concludes the following:



### 1. The basic formula CSF for the proposed end-use**produc~** 

### Thidiazuron-Diuron 4.5SC dated 27 Feb 2007 is acceptable.



### 2. This submission satisfies the data req uirements as specified in 40 GFR 158.155, 158.160, 158.165, 158.167, 158.175, and 158.180 with respect 

### to product identity and composition, description of materials used to produce the product, description of formulation process, discussion of formation of impurities, certified limits, and enforcement analytical method.

3. Except for storage stability/corrosion characteristics studies, the remaining product chemistry Group B data (MRID# 470765-01) adequately fulfill the data requirements. Infonn the registrant that one-year studies are required 

### to satisfy the storage stability and corrosion characteristics data requirements.

PRODUCT CHEMISTRY DATA (SERIES 830 Subgroup A)

Subgroup A - Product Identity and Composition Data Required MRIO No. Fulfilled

830.1550. Chemical Identity 

### Y 470706-01

830.1600. Beginning Materials 

### Y 470706-01

830.1650. Formulation Process 

### Y 470706-0t

830.1670. Discussion of Impurities 

### Y 470706-01

830.1700. Preliminary Analysis 

### NA

830.1750. Certified Limits 

### Y 470706-01

830. t800. Enforcement Analytical Method 

### N 470706-01

2Enforcement Analytical Method: (MRID No. 470706-01)

The active ingredients, Thidiazuron and Diuron, were determined by reverse phase high performance liquid chromatography (HPLC) using ultraviolet detection (UV) at 220 nm. Method validation was not reported in this submission.

3

### Fees For Service Screen 

### 66330-GAU

The submission is adequate to route to TRB for Product Chemistry review and Acute Toxicity review. The Administrative paperwork is incomplete. In box 6 on tAe ApplicaliOlI Fmm tl11nTarTre-and-registratiorrmr.ora-currentiy-registered-p-esticidecor rlainlnlJ1!lFSli1ffinretmnngre!lJ1lfntne"giSleTed'forihe-proposed-tlses-mtlst-Be 

## ·slieam;tI:- R31 

## I\c+,O(), "'" x to f-))A.UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D.C. 20460



### March 6, 2007

PLEASE RETURN A COpy OF THIS LETTER WITH PAYMENT Or Pay On-Line at www.Pay.Gov (See Below for Details)

OPP Decision Number: D-376316 EPA File Symbol or Registration Nwnber: 66330-GAU Product Name: THIDlAZURON-DlURON 4.55C EPA Receipt Date: 02-Mar-2007 EPA Company Number: 66330 omcEOF PREVENTION, PESTICIDES AND TOXIC SUBSTANCES



### Company Name: ARYSTA LIFESCIENCE NORTH AMERICA CORPORATION

Bill Washburn ARYSTA LIFESCIENCE NORTH AMERICA CORPORATION 15401 WESTON PARKWAY, SUITE 150 CARY, NC 27513-

SUBJECT: Receipt of Registration Appilcation Subject 

## to Registration Service Fee

Dear Registrant:



### The Office 

## of Pesticide Programs has received your application for registration. 

## If you submitted data with this application, the results of the PRN-86-5 screen will be commuoicated separately. During the administrative screen, the Office of Pesticide Programs has detennined 

### that this Action is subject to a Pesticide Registration Service Fee as defined 

## in the Pesticide Registration Improvement Act.

The Action has been identified as Action Code: R31

NEW PRODUCT;NON-FAST TRACK (INCLUDES REVIEWS OF PRODUCT CHEMlSTRY;ACUTE TOXICITY;PUBLIC HEALTH PEST EFFICACy);



### Please remit payment in 

### the amount of: $ 

### 4,200 to:

By USPS:

USEPA Washington Finance Center 

### Pesticide Registration Service Fee PO Box 360277 Pittsburgh, PA 15251

### By Courier: 

# u.s. EPA Washington Finance Center Pesticide Registration Service Fee CIO 

### Mellon Client Service Center 500 Ross Street, Room 670 Box 360277 Pittsburgh,PA 15251-6277 Attn: EPA Module Supervisor Telephone: (412) 236-2294

All payments mnst be in United States currency by check, bank draft, or money order drawn 

### to the order of the Environmental Protection Agency. To ensure proper credit, please write the OPP DECISION NUMBER on your check, and enclose a copy of this letter with your payment.

Effective November 1, 2006, fees may be paid on-line via credit card or electronic fund transfer. To submit a payment on-line, visit www.pay.gov. From the pay.gov home page, select "search by form name." From the next page, select 

## ''P,'' then click on "Pesticide Registration hnprovement Act. Fe'e Payment" and Qomplete the fonn, making certain to use the decision number and registration number on the invoice you receive from the Pesticide Program in 

### the space provided.

You may be eligible for a full 'Or partial waiver of the registration service fee if, for example, you qualifY as a small business or are applying for a minor use, or if your application is solely associated with an ffi.-4 tolerance petition. Please be advised that if you intend to request a waiver, you must do so in writing within 15 days of receipt of this invoice instead of remitting the amount indicated above.**O~P** 

### will not consider waiver requests after the registration service fee has been paid. Information regarding eligibility and how th request and document a fee waiver is available on the OPP Fee for Service web site at www.epa.gov/pesticideslfees.

Please send Registration Service Fee Waiver requests to:

By USPS: Document Processing Desk (WAIVER) Office of Pesticide Programs (7504C) U.S. Enviromnental Protection Agency 1200 Pennsylvania Ave NW Washington, DC 20460 By Courier: Document Processing Desk (WAIVER) Office of Pesticide Programs (7504C) U.S. Environmental Protection Agency Room S4900 Potomac Yard 1 2777 S. Crystal Dr. Arlington, VA 22202

A PRIA decision time review period will not.start until a fee waiver is granted and/or the Agency receives certification that the outstanding fee 

### has been paid. 

### If the Agency does not receive certification of payment-for this action or a fee waiver request within the next 45 days, the Agency will presume that you no longer want to pursue this action. The Agency will then initiate a process that may result in administrative withdrawal of this action.

If you have any questions, please contact"the Pesticide Registration Service Fee

### Ombudsman at (703) 305-6249.

# IFee for Servicel {80628S<-

This package includes the following for Division

## (~ 

# New Registration oAD 

# ° Amendment oBPPD**~RD** [,{j 

# Studies? II 

# Fee Waiver? 

# @] v Risk Mgr. l- 

# vol pay 

# % Reduction:

Receipt No. 

# s-I 806285 

# I

EPA File Symbol/Reg. No. 

# I 66330-GAU 

# I

Pin-Punch Date: 

# I 3/2/2007 

# I

o This item is NOT subject to FFS action.

Action Code: Parent/Child Decisions:
Requested: 

# I**R-~I** 

# I

Granted: 

# I K-3{ 

# I

Amount Due: 

# $ 

# l:/-, .fJJJD

Reviewer:_---.U!6>LJ.1£w.114l'/A1AM"""'''''-'''''/

____ _ Date: 

# '5-1 -07

Remarks:

# e
Arysta LifeScience

February 28, 2007

Ms. Joanne Miller, PM 23 Document Processing Desk (APPL) Office of Pesticide Programs

- 7504P U.S. Environmental Protection Agency One Potomac yard (South Building), Room S-4400 2777 South Crystal Drive Arlington, VA 22202

Dear Ms. Miller:
SUbject: Thidiazuron·Diuron 4.5SC 

## /\1\ EPA Reg. No. 66330·

- LP 

## Jl 

# u.. Application for Registration

Please find enclosed Arysta LifeScience's application for registration of the subjecl product containing the active ingredients thidiazuron and diuron. The following materials are included in this registration package:
1.) Application for Registration
2.) Confidential Statement of Formula
3.) Data Matrix

- Agency and Public copies
4.) Formulator's Exemption Statement
5.) Certification with Respect to Citation of Data
6.) Five (5) copies of Draft labeling

Arysla LifeScience North America Corporation
15401 Weston Parkway, Suile 150, Cary, NC USA 27513 Telephone: (+ 1) 919-678-4900 Fax: (+1) 919-678-2194 www.arystalifescienc€.com 

### 470785·00

### Ms. Joanne Miller Thidiazuron-Diuron 4.5SC February 28, 2007 page 2

Also submitted in support of this application are the toll owing data, three copies 

## of which are enclosed:


### 1.) Thidiazuron-Diuron 

## 4.5SC; OPPTS Guidelines: Product Identity and Composition, Description 

## of Materials Used to Product the Product, **Description of**  **Formulation Process,**  **Discussion** 

### of **Formation** 

### of Impurities, and Certified Limits; Guideline Reference Number 830.1550 thru 830.1800; 16 pages with Confidential Attachment
47070601 

### Study No. MFC2006-D2 MRID No.

____ _ 

### 2.) Physical Properties 

## of Thidiazuron-Diuron 

## 4.5SC; Guideline Reference Number 830.6302 thru 830.7300; 12 pages
Study No. MI-D603 MRID No.**_~_47_0_76_5_01,-** 

### 3.) Acute Oral Toxicity Up and Down Procedure in Rats; Guideline Reference No. 870.1100 (2002), 17 pages 47070603 

### Laboratory Study No. 19603 MRID No.

____ _ 

### 4.) Acute Dermal Toxicity Study in Rats

- Limit**Tes~** 

### Guideline-Reference No. 870.1200 (1998), 14 pages
47070604 

### Laboratory Study No. 19604 MRID No.

____ _ 

### 5.) Acute Inhalation Toxicity Study in Rats

- Limit Test, Guideline Reference No. 870.1300 (1998), 22 pages 47070605 

### Laboratory Study No. 19605 MRID No.

____ _ 

### 6.) Primary Eye Irritation Study in Rabbits; Guideline Reference No. 870.2400 (1998),15 pages 47070606 

### Laboratory Study No. 19606 MRID No.

____ _ 

### 7.) Primary Skin Irritation Study in Rabbits; Guideline Reference 870.2500 (1998),15 pages
Laboratory Study No. 19607 MRID No. 4707\)607



# -----

# I

, I Please read instructions on reverse before comp/e.,,, (0=. Form Approved, ,3 No, 2070-0060, Approval expires 05-31-98



# - EPA United States [81 Registration opp Identifier Number 

# 0 Environmental Protection Agency 

# o Amendment Washington, DC 20460 

# o Other:

### ~?S- Application for Pesticide
M Section I
1. Company/Product Number 2. EPA Product Manager 3". Proposed Classification 

### 66330-G?) 

### U JOANNE MILLER 4. CompanylF'rOduct (Name) PM" 

## [gI None 

# o Restricted THIDIAZURON-DIURON 4.SSC 

### 23 5. Name and Address of Applicant (/nclude ZIP Code) 6. Expedited Review. In accordance with FIFRA Section 3(c)(3)

Arysta LifeScience North America Corporation (b)(l), my product is similar or identical in composition and labeling to: 15401 Weston Parkway, Suite 150 EPA Reg. No. Cary, NC 27513 Product Name 

# o Check if this is a new address

Section
M II

D Amendment- Explain below. D Final printed labels in response to Agency letter dated D Resubmission in response to Agency letter dated_ D "Me Too" Application D Notification

- Explain below. 

# l:2J Other

- Explain below Explanation: Use additional page(s) if necessary. (For Section I and Section II.)



### PRIA CATEGORY, R31 JUSTIFICATION: New Product, Non-Fast Track, Product Chemistry and Acute Toxicology Review required.

CONTACT: bill.washburn@arystalirescience.com



### Section

- III

1. Material This Product WlII Be Packa ed In: Child-Resistant Packaging Unit Packaging Water Soluble Packaging 2. Type ot Container DYes' 

# DYes D y., D Metal 

### [8J No 

### [8J No 

### [8J No 

# IZI Plastic If "Yes" No. per If"Yes" No. Per D Glass 

### * 

### Certification must Unit Packaging wgl. container Package wgl. Container D Paper 

### be submitted D Other (Specify)
3. Location of Net Contents Information 4. Slze(s) Retail Container 5. Location of Label Direcfions 

# IZI Label D Container 

# IZI On Label 2.5 gal., 5.0 gaL, 30 gal., and bulk 

# D On labeling accompanying product
6. Manner in Which Label is Affixed to Product 

# o Lithograph 

# o other (gJ Paper glued 

# o Stenciled
Section
M 

### IV

1. Contact Point (Complete items directly below for identification of individual to be con/acted, if necessary, to process this application) N,me TiUe Telephone No. (Include Alea

Bill Washburn Regulatory Affairs Manager Code) 901-432-5118
Certification 

### 6. Date Application I certify that the statements I have made on this torm and all attachments thereto are true, accurate and complete. I" 

## "



# . Re>.ctliv.ed: acknowledge that any knowingly false or misleading statement may be punishable by fine or imprisonment or both : 

# . . (,&'talnped)
, under appUcable law. 

### • 

# . , 2. SlgnatureB:su 3. Title 

# 'j:**~Q,Q~** Regulatory Affairs Manager 

# . , 

# .. 

# .. , 4. Typed Name . , "
, 

# . 

# . 5. Date 

### ; 

## : 

# . , 

## " Bill Washburn 

### February 28,2007 

# " "i' ,

, 

### "

. 

## .. EPA Form 8570-1 (Rev. 8 94) PrevIOus edItIons are obsolete 'V < Whlte- EPA FIle Copy (ongmal) .p)lp}'o ApplJcant Copy



### , 

## "

, , ,UNITED STATES ENVIRONMENTAL PROTECTID'" AGENCY WASHINGTON, D.C. 20460



### March 13,2007

ARYSTA LIFESCIENCE NORTH AMERICA CORPORATION 15401 WESTON PARKWAY, SUITE 150 CARY, NC 27513-

Report of Analysis for Compliance with PR Notice 86-5 OFFICE OF PREVENTION, PESTICIDES AND TOXIC SUBSTANCES



### Thank you for your submittal of 13-MAR-07. Our staff has completed a preliminary 

## analysis of the 

## material. The results are provided as follows:

Your submittal was found to be in full compliance with the standards for submission of data contained in PR Notice 86-5. A copy of your 

## bibliography is enclosed, annotated with 

## Master Record IDs (MRIDs) assigned to each document submitted. Please use these numbers in 

## all 

## future references to these documents. Thank you for your cooperation. If you have any questions concerning this data submission, please raise them 

## with the cognizant Product Manager, to whom the data have been released.-UNITEDSTATESENVIRONMENTALPROTECTIONAGENCYFormApprovedOMBNo.2070·00600401MStreet,S,W.WASHINGTON.D.C.20460PaparworkReductionActNotice:Thepublicreportingburdenforthiscollect[onofinformationIsestimatedtoaverage0.25hoursperresponseforregistrationactivitiesand0.25hoursperresponseforreregistrationandspecialreviewactivities,Includinglimeforreadingtheinstructionsandcompletingthenecessaryforms.SendcommentsregardingtheburdenestimateoranyotheraspectofthiscollectionofInformailon,Includingsuggestionsforreducingtheburden10:Director,OPPEInformationManagementDivision(2137).U.S.EnvironmentalProtectionAgency,401MSireel,S.W.,Washington,DC20460.Donolsendtheform10[hisaddress.DATAMATRIXDateFebruary27.2007EPAReg.No.lFileSymbol66330-IPage1of1AppUcant'sJRegislrant'sName&Address:ProductArystaLifeSciencoNorthAmericaCorp.,15401WestonParkway,Suite150,Cary.NC27513THIDIAZURON-DIURON4.5SCIngredient(s):Thidlazuron,DiuronGuidenneReferenceNumberGuidelineStudyNameMRIDNumberSubmitterStatusNoteProductChemistry-_./830.AProductIdentityandComposition,etalAryslaLifeScienceNorthAmericaSubmiti830.BPhysicalandChemicalCharacteristicsAryslaLifeScienceNorthAmericaSubmitAcuteToxicology870.1100AculeOralToxicitUfeScienceNorthAmericaSubmit870.1200AcuteDermalToxicJ!y_&lstaLifeScienceNorthAmericaSubmit870.1300AcuteInhalationToxicityLifeScienceNorthAmericaSubmit870.2400PrimaE eIrritationAstaUfeScienceNorthAmericaSubmit870.2500PrimaryDermallrritalionAryslaLifeSclenceNorthAmericaSubmit870.2600SkinSensitizationArystaLifeScienceNorthAmericaSubmitGenericDataCite-AllBayerCropScienceLPPayEPACo.No.264ChemturaUSACorporationPayEPACo.No.400Makhteshim-AganofN.A.PayEPACo.No.66222-...Cite-AllSprayDrifttaskForcePayEPACo.No.66607:'--OutdoorResidentialExposureTFPay".-EPACo.No.71754-3:::ite-'\1I.:.-.AgriculturalReentryTFPay-..---EPACo.No.71755.NationsAgII,LLCPay.EPACo.No.72167u _".:--::Ciw:AII.SRMChemical,Ltd.Co.Pay.......EPACo.No.73631......Cfte-AII.AgHandlersExposureTFPay".EPACo.No.75234SignatureNameandTitle:fDateBillWashburn.RegulatoryAffairsManager07/10/2006--PAForm8570_35[S·S7)EleclronlcandPaperversionsavailable.SubmilonlyPape>version.AgoncyInternalUseCopyForm approved. OMS NO. 2070·0060. Aporoval Expires 1-30·93 United States Environmental Protection Agency 

## I'll Washington, D.C. 20460 

# o EPA Formulator's Exemption Statement (40 CFR 

## 152.85) Applicanfs Name and Address EPA File Symbol/Registration Number Arysta LifeScience N.A. Corporation**66330~** 15401 Weston Parkway, Suite 150 Product Name Cary, NC 27513 THIDIAZURON-DIURON 4.5SC
Date of Confidential Statement of Formula (EPA Form**8~704)** 

### 02/27/07

As an authorized representative of the applicant for registration of the product identified above, I here certify that (t) This product contains the following active ingredient(s): Diuron

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

## ~ (A) An accurate Confidential Statement of Formula (EPA Form 8570-4) for the above identified product is attached to this statement. That formula statement indicates, by company name, registration number, and product name, the source of the active ingredient(s) listed in paragraph (1). OR 

# o (B) The Confidential Statement of Formula (CSF) (EPA Form 8570-4) referenced above and on file with the EPA is complete, current, and accurate and contains the information required on the current CSF.

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

Source

Active Ingredient Product Name Registration Number

Diuror,

, > > > >. ,

> , , ,


### , '"
, 

### ""

,



### , , 

### ,
, , >0 , 

### " "
, 

### , ,

, " 

### "

, >

" " J.'

, >

, >0 " , , ' " "
, >

Signature Name and Title Date

# <;~~""'~ Bill Washburn, February 27, 2007 ReQulatorv Affairs Manaaer



### - - EPA Form 8570 27 (Rev. 7 91) White

- EPA copy Yellow· Applicant copyF A MB orm pproved 0 No. 2070-006



# -**U~,.** 

# do STATES ENVIRONMENTAL PROTEC

.

## ~N AGENCY 

# 0 401 M Street, S.W. WASHINGTON, D.C. 20460
Paperwork Reduction Act Notice: The public reporting burden for this collection of information is estimated to average 1.25 hours per response for registration activities and 025 hours per response for reregistration and spedal review activities, including time for reading the instructions and completing the necessary forms. Send comments regarding the burden estimate or any other aspect of this collection of information. including suggestions for reducing the burden to: Director. OPPE Information Management Division (2137). U.s. Environmental Protection Agency. 401 M Street, S.W., Washington, DC 20460. Do not send the fOrm to this address.

Certification with Respect to Citation of Data AppJicanfsJRegistrant's Name, Address and Telephone Number EPA Registration Numberl File Symbol Arysta LifeScience N. A. Corp., 15401 Weston Parkway, Suite 150, Cary, NC 27513 66330
Active Ingredient(s) andlor representative test compound(s): Date Thidiazuron, Diuron Feb rua rv27,2007 General use pattem(s) (list all those claimed for this product using 40 CFR Part 158) Product Name Terrestrial, Non-Food Use (Cotton) THIDIAZURON-DlURON SC

NOTE: If your puduct 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. You must submit the Formulator's ExemDtion Statement (EPA Form 8570-27), 

## 0 I am responding to a Data Call-In Notice, and have included with this form a list of companies sent offers of compensation (the Data Mabix form sh::luld be used for this purpose).
SECTION I: METHOD OF DATA SUPPORT (Check one method onlv) 

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

## I8l I am using the selective method of support (or cite-all option this form a list of companies sent offers of compensation (the under the selective method), and have included with this form a 

### Data Matrixform should be used for this purpose).**comple~~d** list of data requirements (the Data Matrix form must be used.
SECTION II: GENERAL OFFER TO PAY [Required if using the cite-all method orwhen using the cite-a1J option under the selective method to satisfy one or more data requirements] 

## I8l 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 Notice is supported by all data submitted
or cited in the application for registration, the form for reregistration, or this Data Call-In response. In addition, if 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) concem the properties or effects of this product or an identical or substantially s[milar prodUct, or one or more of the ingredients in this product; and (2) is a type of data that would be required to be submitted under the data requirements in effect on the date of approval of this application if the application sought the initial registration of a product of identical or similar composition and uses.

I certifY that for each exclusive use study cited in support of this registration or reregistration, that I am the original submitter or that I have obtain&l? the written permission of the original submitter to cite that study.**~** > , > I cer"..itYlnat J for each study cited in support of this registration or reregistration that is not an exclusive use study, either: (a] I am the original**data~slibmitter; (~),I**  ,h,a,ve obtained the written permission of the original data submitter to use this study in support of this application; (c) all periods fJ,f**e~1ibility** for compensation have expired for the study; (d) the study is in the public literature; or (e) I have notified in wri!i!1g**1h~compaH'I ~j-.'(:,t**  submitted the study and have offered (0 to pay compensation to the extent required by sections 3(c)(1)(F) andlbr 3i'C¥2)(8) d FIFRA; and (ii) 

### to commence negotiations 

### to determine the amount and terms of compensation, if any, to be paid for the use of the stud!l. '

J , , , " I certify that in all**'hstanrJ~s** where an offer of compensation is required, copies of all offers 

### to pay compensation and evidence of their delivery,jrJ aZ'iordancp, y..jfp.,*ctions 3(C)(1)(F) and/or 3(c)(2)(8) of FIFRA are available and will be submitted' to the agency upon request. Should I fuil to produce such evidence to the Agency upon request, I understand that the Agency may initiate action 

### to deny, cancel or suspend the registration of my product in COrlormity with FIFRA.

I certify that the statements I have made on this form and all attachments to it are true, accurate and complete. I acknowledge that any knowingly false or misleading statements may be punishable by fine or imprisonment 

### or both under applicable law.

Signature

### (6~ Date Typed or Printed Name and TIUe

# ~~ 2/27/07 Bill Washbw-n, Regulatory Affairs Manager



# - EPA Form 8570 34 (9-97) ElectroniC and Paper versions available. Submit only Paper version..1



# THIDIAZURON-DIURON 4.5SC
COTTON DEFOLIANT
For Agricultural Use Only 

### ACTIVE INGREDIENTS: Thidiazuron: N-phenyl-N'-1 ,2,3-thidiazol-5-yJurea*

...... '"

......... "

....... 36.06% Diuron: 3-(3,4-dichlorophenyl)-1, 1-d'lmethylurea*

................................................................ 18.04% Other Ingredients:

............................................ '

............................................................ 45.90% TOTAL 100.00%

Contains 3 lb. Thidiazuron per galion and 1.5Ib. Diuron per gallon

KEEP OUT OF REACH OF CHILDREN CAUTION Si usted no entiende la etiqueta, busque a alguien para que se la explique a usted en detalle. (If 

### you do not understand this label, find someone to explain it to you in detail.)

FIRST AID IF SWALLOWED: 

# • Immediately call a poison contrd center or doctor for treatment advice. 

# • Do not induce vomiting unless told to do so by a poison control center or doctor. 

# • Have person sip a glass or water if able to swallow.


## • Do not give anYthing by mouth to an unconscIous person. IFIN 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. NOTE TO PHYSICIAN: Probable mucosal damage may contraindicate the use of gastric lavage. HOT LINE NUMBER Have the product container or label with you when calling a poison control center or doctor

or going for treatment. EMERGENCY NUMBERS: FOR 24- HOUR EMERGENY MEDICAL ASSISTANCE CALL: 1-866-303-6952 FOR CHEMICAL EMERGENCY: Spill, leak, fire, exposure, or accident call CHEMTREC 1-800-424-9300

SEE INSIDE (SIDE PANEL) FOR ADDITIONAL PRECAUTIONS AND USE DIRECTIONS

EPA Reg. No. 66330-xxx ADxxxxxx EPA Est. No. 51036-GA-001 NET CONTENTS:

__ _
Manufactured by Arysta LifeScience North America Corporation 15401 Weston Parkway, Suite 150 Cary, NC 27513

Filename: Thidiazuron-Diuron 4.5SC (xxx-021607) 

### "

"

,

, 

# .. • 

### , ,> "



## "

, , , 

### , "


### , "


### ,

Page 1PRECAUTIONARY STATEMENTS HAZARDS TO HUMANS AND DOMESTIC ANIMALS CAUTION Harmful jf swallowed. Causes moderate eye irritation. Avoid contact with eyes or clothing. Wash thoroughly with soap and water after handling and before eating, drinking, chewing gum, or using 

### tobacco

..
PERSONAL PROTECTIVE EQUIPMENT Applicators and other handlers (other than mixers and loaders) must wear:



### • Coveralls worn over long-sleeved shirt and long pants

• Chemical-resistant gloves, such as barrier laminate or butyl rubber gloves

• Chemical-resistant footwear plus socks



### • Protective eyewear Mixers and loaders must wear:



### • Coveralls worn over long-sleeved shirt and long pants

• Chemical-resistant gloves, such as barrier laminate or butyl rubber gloves

• Chemical-resistant footwear plus socks

• Protective eyewear Discard clothing and other absorbent materials that have been drenched or heavily contaminated with this producfs concentrate. Do not reuse them. Follow manufacturer's instructions for cleaning/maintaining PPE. If no such instructions for wash ables, use detergent and hot water. Keep and wash PPE separately from other laundry.

ENGINEERING CONTROLS STATEMENT When handlers use closed systems, enclosed cabs, or aircraft in a manner that meets the requirements listed in the Worker Protection Standard (WPS) for agricultural pesticides [40 CFR 170.240 (d) (4-6)], the handler PPE requirements may be reduced or modified as specified in the WPS.

USER SAFETY RECOMMENDATIONS Users should:

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

• Remove clothing immediately if pesticide gets inside. Then wash thoroughly and put on clean clothing.

• Remove PPE immediately after handling this product. Wash the outside of gloves before removing. As soon as possible, wash thorouQhly and chanQe into clean clothinQ.

ENVIRONMENTAL HAZARDS 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 contaminate water by cleaning of equipment or disposal of equipment washwaters. Do not apply when weather conditions favor drift from treated areas.

GENERAL INFORMATION THIDIAZURON-DIURON 4.5SC is a harvest aid for cotton, used for leaf removal prior to harvest. THIDIAZURON-DIURON 4.5SC can be applied in most weather conditions, both wann and cool.

USE PRECAUTIONS This product is not to be applied through any type of irrigation system. Effectiveness of THIDIAZURON-DIURON 4.5SC will be reduced if rainfall occurs within 12 hours post application. Foliage from treated plants or gin trash is not to be fed to livestock.

Filename: Thidiazuron-Diuron 4.SSC (xxx-021 607) Page 2Rotation to the following crops requires the minimum specified periods below after the last application ofTHIDIAZURON-DIURON 4.5SC: small grains, sorghum, corn, or root crops (except carrots, onions)

................................. two (2) months legumes (including alfalfa) or leafy vegetable (except lettuce)

....................................... two (2) months cole crops, garlic, safflower, tomatoes, and watermelon

............................................... two (2) months carrots

........................................................................................................... three (3) months onions

........................................................................................................... four (4) months cantaloupe, honeydew melon/casaba melon, muskmelon, or peppers

......................... five (5) months lettuce

........................ when soil has been deep-plowed (12-15 inches)

...................... two (2) months

OR lettuce

.......... when soil is only disced (4-6 inches)

.................................... nine (9) months All other crops

.............................................................................................. twelve (12) months
Special Note for inter-cropped grains and legumes planted either as cover crops or planted into treated fields before the minimum two (2) month plant back time after the final THIDIAZURON-DIURON 4.5SC application: Any such crops are prohibited for use as feed or food and may be used only as cover crops.

Immature crops should not be used for food or feed.

Prevent spray drift from contacting crops other than mature cotton, since this product may defoliate or injure other plant species.

Mixtures with organophosphates can increase nontarget crop phytotoxicity. Additional care should be exercised when lettuce, citrus, cantaloupes or any other edible crops are adjacent to THIDIAZURONDIURON 4.5SC treated cotton fields.

PROCEDURES TO LOWER SPRAY DRIFT POTENTIAL ONTO NONTARGET CROPS Under windy weather conditions, applications of THIDIAZURON-DIURON 4.5SC may drift to non-target crops. The following procedures can help reduce the potential for drift:

• If wind speeds top ten (10) miles per hour at the application site, do not make aerial or ground applications of THIDIAZURON-DIURON 4.5SC.

• Nozzle pressure of 20-30 psi is recommended.

• Do not apply this product during a temperature inversion because drift potential is high. In addition, do not apply this product if the development of a temperature inversion appears likely during the application period.

• This product should not be applied by ground within 100 feet or by air within 0.5 mile of lettuce.

RIO GRANDE VALLEY OF TEXAS PROCEDURES TO LOWER SPRAY DRIFT POTENTIAL The following procedures can help reduce the potential for drift:

• If wind speeds top ten (10) miles per hour at the application site, do not make aerial or ground applications of THIDIAZURON-DIURON 4.5SC. If wind speeds are less than ten (10) miles per hour, observe local recommendations from your State Extension Cotton SpecialiSt.

• Nozzle pressure of 20-30 psi is recommended.

• Do not apply this product during a temperature inversion because drift potential is high. In addition, do not apply this product if the development of a temperature inversion appears likely during the application period.

• The maximum nozzle orifice size that provides proper coverage and deposition of this product should be used.

• CITRUS AREAS: This product should not be applied by ground within 0.5 mile or by air within 5 miles upwind of citrus in flush.

Filename: Thidinuron-Diuron 4.5SC (xxx-02J 607) Page 3DIRECTIONS FOR USE 

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



### Do not make applications of this product that may contact workers or other person either by 

### drift or directly. Protected handlers only are allowed in the area during application. Consult your State or Tribe agency responsible for pesticide regulations for any specific recommendation.

AGRICULTURAL USE REQUIREMENTS Use this product only in accordance with its labeling and with the Worker Protection Standard, 40 CFR 

### Part 170. This Standard contains requirements for the protection of 

### agricultural workers on farms, forests, nurseries, and greenhouses, and handlers of agricultural pesticides. It contains requirements for training, decontamination, notification, and emergency assistance. It also contains specific instructions and exceptions pertair:ing to the statement on this label about personal protective equipment (PPE), and restricted-entry interval. The requirements in 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 24 hours.

PPE required for early entry to treated areas that is permitted under the Worker Protection standard and thaI involves contact with anything that has been treated, such as plants, soil, or water, is:

• Coveralls worn over long-sleeved shirt and long pants

• Chemical-resistant gloves such as barrier laminate or butyl rubber gloves

• Chemical-resistant footwear plus socks

• Protective evewear

TIME OF APPLICATION THIOIAZURON-OIURON 4.5SC defoliant applications are to be made only on mature cotton plants when the uppermost harvestable boll is mature. Boll maturity-is defined as 1) when a boll is squeezed between thumb and finger, it does not dent; 2) when cutting a cross section with a sharp knife is difficult; 3) when seeds in cross section lack liquid within the seed coat or outer edges of seed coat are light brown; and 4) when fully developed cotyledons are present.

Make applications of THIOIAZURON-OIURON 4.5SC at least 5 days prior to expected harvest date.

NOTE: Adequate defoliation with THIOIAZURON-OIURON 4.5SC depends on three factors:

• Cotton is actively growing.

• High relative humidity.

• Cotton plant leaveS are turgid and not desiccated.

ATTENTION: Desiccation and/or leaf freezing may occur during periods of high temperature when adjuvants are added to THIOIAZURON-DIURON 4.SSC application solution. Products and adjuvants known to cause desiccation of cotion leaf tissue should not be used.

Under low nighttime temperatures (below 60°F) or otherwise adverse conditions, this product, when used alone, may provide less than expected defoliation and / or regrowth suppression.

Likewise, cotton that does not have a uniform boll load, has excessive vegetative growth and/or is being defoliated with less than 65% open boll then a tank mixture of adjuvants and other defoliant materials should be considered.

APPLICATION INFORMATION Use an adequate volume of water with the recommended amount of THIOIAZURON-OIURON 4.5SC defoliant to uniformly and completely cover leaves. For ground equipment, apply 

### 10

- 25 gallon per acre and by air, use 2 

### -10 gallons per acre. Maintain agitation during application.

Filenall1e: Thidiazuroll-Diuron 4.SSC (xxx-021 (07) Page 4DOSAGE INFORMATION

In some situations, a follow-up application may be needed. THIOIAZURON-DIURON 4.5SC may be used for this application. Other defoliants may be needed. If additional boll opening is required, Ethephon 6 or any other boll-opening products may be used at recommended rates; see product label for rates and timings. Consult your local State Extension Cotton Specialist recommendations for rates and timings.

The maximum annual use rate of THIOIAZURON-DIURON 4.5SC is 5.33 

### fl. oz. (0.33 pints) per acre per


### season. MIXING INSTRUCTIONS 1. Fill spray applicator tank with at least one half of the water to be used 2. Start agitation 3. Add the appropriate volume of THIDIAZURON -D!URON 4.5SC 4. Continue agitation and fill tank with the remainder of the water to be used 5. Agitation should continue throughout the application

PRECONDITIONING When used as a pre-conditioner seven to ten days before application of this or other defoliant compounds, this product will improve the efficacy of such a defoliant application. Before use, observe all product label directions, recommendations and prohibitions on both products' labels.

PRECONDITIONING APPLICATION RATE for THIDIAZURON-DIURON 45SC



## - THIDIAZURON-DIURON 4_5SC One Gallon of Gallons of S ray Solution Formulated Product THIDIAZURON-DIURON 4.5SC Will Treat Air Ground 0.67 FI. Oz. 191 1.33 

### FI. Oz. 96 2-10 10-25 2.00 FI. Oz. 48

STANDARD APPLICATION STANDARD APPLICATION RATE: Use 1.33-2 fl.oz. of this product/acre in an aerial application of 2-10 gallons of spray solution or ground application of 10-25 gallons of spray solution.

APPLICATION RATE TABLE forTHlDlAZURON DIURON 4 5SC



# - THIOIAZURON-OIURON 4.5SC One Gallon of Pounds Active Gallons of Spray Solution Formulated Product THIDIAZURON- Ingredients DlURON 4.5SC per Acre Will Treat Air Ground 0.67 fl. oz.lAcre 191 Acres 0.0235 (0.04 pUAere) 1.33 fl. oz./Acre 96 Acres 0.048 (0.08 pUAere) 2.13 fl. oz./Acre 60 Acres 0.075

(0.13 pUAere) 2-10 10-25

### ~t3 fl.

### oz.lA~~ 45 Acres 0.10 0.18 Dt.lAcre 4.27 fl. ozJAcre 30 Acres 0.15 (0

.. 27 pUAere) 5.33 fl. oz.lAcre 24 Acres 0.1875 (0.33 pUAere)

RESTRICTIONS:

• Do not apply more than 0.33 pint of Thidiazuron-Diuron 4.5SC per acre per season.

• Do not exceed maximum label rate with split applications of Thidiazuron-Diuron 4.5SC.

Filename: Tbidiazuron-Diuroll 4.SSC (xxx-02 (607) 

### PageSIMPORTANT CLEANOUT INSTRUCTIONS 

### When applying THIDIAZURON-DIURON 4.5SC, a residue may form in application equipment. This residue can best be flushed out of the spraying system by using a commercial tank cleaner when done while residue is still fresh and moist. DO NOT ALLOW EQUIPMENT TO DRY BEFORE CLEAN OUT. Consult your State Extension Cotton Specialist for recommended tank cleaners and cleaning procedures.

Tank cleaner and water should be used immediately after application. The entire system including nozzles, booms, application tanks, sumps, pumps, and transfer lines should be flushed. Allowing the spray solution to dry in the application equipment can result in residues that are more difficult to remove. 

### Dried residues are extremely difficult to remove. To remove such dried residues, fill the affected equipment to capacity with commercial tank cleaner solution and let it remain for 7 days. AftelWards, the equipment will need to be thoroughly flushed and rinsed.
Spray application equipment that has been inadequately cleaned 

### will contain residue ofTHIDIAZURONDIURON 4.5SC. Such improper cleaning could lead to crop damage in later applications.
Arysta LifeScience North America Corporation assumes no liability due to equipment that has not been properly cleaned.

STORAGE AND DISPOSAL 

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

PESTICIDE STORAGE: Store this product in a cool, dry place in its original container only. Container should be closed when not in use. Do not expose the product to open flame excessive heat. Store in original container and keep closed.

PESTICIDE DISPOSAL: Pesticide wastes are acutely hazardous. Improper disposal of excess pesticide, spray 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 Control Agency, or the Hazardous Waste representative at the nearest EPA Regional Office for guidance.

To Contain a Spill: Absorb liquid by covering it with cat litter, commercial clay, lime, sand, sawdust, or soda ash. Once absorbed, bury the cleaning materials and cleanse the spill area with a detergent and water solution.

CONTAINER DISPOSAL: Triple rinse (or equivalent); then offer for recyding or reconditioning, or puncture and dispose of in sanitary landfiJl, or by other procedures approved by State and local authorities.

DO NOT REUSE EMPTY CONTAINER

CONDITIONS OF SALE



### 1. It is impossible to eliminate all risks associated with the use of this product. Such risks may arise from weather conditions, soil factors, off-target movement, unconventional farming techniques, the presence of other materials, the manner of use or application, or other unknown factors, all of which are beyond the control of Arysta LifeScience North America Corporation ("Arysta"), and can cause crop injury, injury to non-target crops or plants, ineffectiveness of the product, or other unintended consequences. All such risks shall be assumed by the user or buyer. 2. Arysta warrants that this product conforms to the chemical description on the label and is reasonably 

### fit for the purposes stated in the Directions for Use, subject to the inherent risks described above, when used in accordance with the Directions for Use under normal conditions. 3. This warranty does not extend to the use of this product contrary to label instructions or under conditions not reasonably foreseeable to Arysta, and is subject to the inherent risks described above. TO THE EXTENT CONSISTENT WITH APPliCABLE LAW, ARYSTA DISCLAIMS ALL OTHER WARRANTIES, EXPRESSED OR IMPLIED, INCLUDING ANY WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE. TO THE EXTENT CONSISTENT WITH APPLICABLE

Filename: Thidiazuroli-Diuron 4.5SC (xxx-OJ 1607) Page 6LAW, ARYSTA, MANUFACTURER, AND SELLER DISCLAIM AND SHALL NOT BE LIABLE FOR ANY SPECIAL, INCIDENTAL, INDIRECT, OR CONSEQUENTIAL DAMAGES RESULTING FROM THE USE, HANDLING, APPLICATION, STORAGE, OR DISPOSAL OF THIS PRODUCT OR FOR DAMAGES IN THE NATURE OF PENALTIES, AND THE USER AND BUYER WAIVE ANY RIGHT THAT THEY MAY HAVE TO SUCH DAMAGES. NO AGENT, REPRESENTATIVE OR EMPLOYEE OF ARYSTA IS AUTHORIZED TO MAKE ANY WARRANTY, GUARANTEE OR REPRESENTATION BEYOND THOSE CONTAINED HEREIN OR TO MODIFY THE WARRANTIES CONTAINED HEREIN. 4. TO THE EXTENT CONSISTENT WITH APPLICABLE LAW, THE EXCLUSIVE REMEDY OF THE USER OR BUYER, AND THE TOTAL LIABILITY OF ARYSTA, MANUFACTURER, AND SELLER, SHALL BE LIMITED TO THE PURCHASE PRICE PAID, OR AT ARYSTA'S ELECTION, THE REPLACEMENT OF THE PRODUCT.

Filename: Thidillzuron-Diuron 4.5SC (xxx-021607) Page 7THIDIAZURON-DIURONSCCOTTONDEFOLIANTForAgriculturalUseOnlyACTIVEINGREDIENTS:Thidiazuron:N-phenyl-N'-I,2,3-thidiazol-5-ylurea*...........................36.06%Diuron:3-(3,4-dichlorophenyl)-I,I-dimethylurea*....._......................18.04%OtherIngredients:...................................................................45.90%TOTAL.....................................................................1000/0C0111ains3lb.Thidiazuronpergallol\and1.5lb.DiuronpergallonKEEPOUTOFREACHOFCHILDRENCAUTIONSinstednoentiendelaetiqueta,busqueaalguienparaqueselaexpHqueaustedendetalle.(lfyolldonotunderstandthislabel,findsomeonetoexplainittoyouindetaiL)FIRSTAIDIFSWALLOWEDInmlediatelycallapoisoncontrolcenterordoctorfortreatmentadvice.Donotinducevomitingunlesstoldtodosobyapoisoncontrolcenterordoctor.Havepersonsipaglassorwaterifabletoswallow.DonotgivebymouthtoanunconsciousperSonIFINEYES:Holdeyeopenandrinseslowlyandgentlywithwaterfor15-20nunutes.Removecontactlenses,ifpresent,afterthefirst5mhmtes,thencontinuerinsing.CallapoisoncontrolcenterordoctorfortreatmentadviceNOTETOPHYSICIAN:ProbablemucosaldamagemaycontraindicatetheuseofgastriclavageHOTLINENUMBERI·lavetheprodl1ctcontainerorlabelwithyouwhencallingapoisoncontrolcenterordoclorotgoingfortreatment.EMERGENCYNUMBERS:•Transportationorspill,callCHEIv!TREC800-424-9300.•Humanhealdl,800-832-HELP(4357).•Animalhealth,callASPCAat800-345-4735SEEATTACIIEDIJOOKLETFORADDITIONALPRECAUTIONSANDUSEDIRECTIONSl'ill'nal11C:Thidiazuron-DinfOn4.SSC(xxx-OZI607)PRECAUTIONARYSTATEMENTSHAZARDSTOHUMANSANDDOMESTICANIMALSCAUTIONHarmfulifswallowed.Causesmoderateeyeirritation.Avoidcontactwitheyesorclothing.Washthoroughlywithsoapandwaterafterhandlingandbeforeeating,drinking,chewinggum,orusingtobacco..ENVIRONMENTALHAZARDSDonotapplydirectlytowater,ortoareaswheresurfacewaterispresent,ortointertidalareasbelowIhemeanhighwatermark.Donotcontaminatewaterbycleaningofequipmentordisposalofequipmentwashwaters.Donotapplywhenweatherconditionsfavordriftfromtreatedareas.DIRECTIONSFORUSEItisaviolationofFederallawtousethisproouctinamannerinconsistentwithitslabeling.Donotmakeapplicationsofthisproductthatmaycontactworkersorotherpersoneitherbydriftordirectly.Protectedhandlersonlyareallowedintheareaduringapplication.ConsultyourStateorTribeagencyresponsibleforpesticideregulationsforanyspecificrecommendation.STORAGEANDDISPOSALDonotcontaminatewater,food,orfeedbystorageordisposal.PESTICIDESTORAGE:Storethisproductinacool,dryplaceinitsoriginalcontaineronly.Containershouldbeclosedwhennotinuse.Donotexposetheproducttoopenflameexcessiveheat.Storeinoriginalcontainerandkeepclosed.PESTICIDEDiSPOSAL:Pesticidewastesareacutelyhazardous.Improperdisposalofexcesspesticide,spraymixture,orrinsateisaviolationofFederallaw.Ifthesewastescannotbedisposedofbyuseaccordingtolabelinstructions,contactyourStatePesticideorEnvironmentalControlAgency,ortheHazardousWasterepresentativeatthenearestEPARegionalOfficeforguidance.ToContainaSpill:Absorbliquidbycoveringitwithcatlitter,commercialclay,lime,sand,sawdust,orsodaash.Onceabsorbed,burythedeaningmaterialsaoocleansethespillareawithadetergentandwatersolution.CONTAINERDISPQSAL:Triplerinse(orequivalent);thenofferforrecyclingorreconditioning,orpunctureanddisposeofinsanitarylandfill,orbyotherproceduresapprovedbyStateandlocalauthorities.DONOTREUSEEMPTYCONTAINEREPAReg.No.66330-xxxEPAEst.No.51036-GA-001ADxxXxxNETCONTENTS:___Page8ManufacturedbyArystaLifeScienceNorthAmericaCorporation15401WestollParkway,Suite150Cary,NC27513

## 1

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



### March 8, 2007

ARYSTA LIFESCIENCE NORTH AMERICA CORPORATION 15401 WESTON PARKWAY, SUITE 150 CARY, NC 27513-

,



### Report of Analysis for Compliance with PR Notice 86-5 OFFICE OF PREVENTION, PESTICIDES AND TOXIC SUBSTANCES



### Thank you for your submittal of 02-MAR-07. Our staffhas completed a preliminary analysis of the material. The results are provided as follows:

Your data submittal was found to be partially 

### in compliance with the standards for 

### submission of data contained in PR Notice 86-5, with the exceptions noted below. A copy of
your transmittal bibliography is enclosed, armotated with the Master Record ill's (MRIDs) 

## assigned to each document accepted. Please use these numbers in 

## all future references to these documents.

If 

### deficiencies were found which apply 

### to 

### individual accepted studies, they are listed below following the applicable MRlD. Any document which has been assigned a MRID has been accepted under PR Notice 86-5. 

### If any comments related to a MRlD appear on this report, 

## they are provided for your infonnation and reference when preparing 

## future submissions. 

## Some individual documents were not acceptable, and all 

## copies are being returned to you for correction for the reasons indicated below.



## These rejected studies have been assigned separate identification numbers which are armotated on both the enclosed bibliography and the rejected document labels.



## The rejected studies and their 

## deficiencies are described below.

Rejected Study [02]: 

# * Judging from the pagination of the study, page 

### 4 was omitted from the submitted
copy.

# · e
Arysta LifeScience

February 28, 2007

Ms. Joanne Miller, PM 23 Document Processing Desk (APPL) Office of Pesticide Programs

- 7504P U.S. Environmental Protection Agency One Potomac yard (South Building), Room S-44OO 2777 South Crystal Drive Arlington, VA 22202

Dear Ms. Miller:
Subject: Thfdiazuron-Diuron 

### 4.SSC EPA Reg. No. 66330- Application for Registration



### Please find enclosed Arysta LifeScience's application for registration of the subject product containing the active ingredients thidiazuron and diuron. The following materials are included in this registration package:
1.) Application for Registration
2.) Confidential Statement of Formula
3.) Data Matrix

- Agency and Public copies
4.) Formulator's Exemption Statement
5.) Certification with Respect to Citation of Data
6.) Five (5) copies of Draft labeling

Arysta UfeScience North America Corporal ion
15401 Weston Parkway, Suhe 150, Cary, NG USA 27513 Telephone: (+1) 919-678-4900 Fax; (+1) 919-678-2194**www.ary~lifescience.com** 

### 470706-00

### Ms. Joanne Miller Thidiazuron-Diuron 4.5SC February 28, 2007 page 2

Also submitted in support of this application are the following data, three copies of which are enclosed:


### 1.) Thidiazuron-Diuron 4.SSC; OPPTS Guidelines: Productldentityand Composition, Description of 

### Materials Used to 

### Product the Product, Description of 

### Formulation Process, Discussion of 

### Formation of 

### Impurities, and Certified Limits; Guideline Reference Number 830.1550 thru 830.1800; 16 pages with Confidential Attachment


### 47070601 Study No. MFC2006-02 MRID No.

____ _ 

### 2.) Physical Properties of 

### Thidiazuron-Diuron 4.5SC; Guideline Reference Number 830.6302 thru 830.7300; 12 pages
Study No. MI-0603 MRID No. _R_e_ 

## J e_ct_(_02_1_



### 3.) Acute Oral Toxicity Up and Down Procedure in Rats; Guideline Reference No. 870.1100 (2002), 17 pages
Laboratory Study No. 19603 

### 47070603 MRID No.

____ _ 

### 4.) Acute Dermal Toxicity Study in Rats- Umit**Tes~** 

### Guideline Reference No. 870.1200(1998), 14 pages 

### 47070604 Laboratory Study No. 19604 MRID No.

____ _ 

### 5.) Acute Inhalation Toxicity Study in Rats

- Umit**Tes~** 

### Guideline Reference No. 870.1300 (1998), 22 pages 

### 47070605 Laboratory Study No. 19605 MRID No.

__**~** 

### __ 

### 6.) Primary Eye Irritation Study in Rabbits; Guideline Reference No. 870.2400 (1998), 15 pages 

### 47070606 Laboratory Study No. 19606 MRID No.

____ _ 

### 7.) Primary Skin Irritation Study in Rabbits; Guideline Reference 870.2500 (1998), 15 pages
Laboratory Study No. 19607 MRIDNo. 

### 47070607

### Ms. Joanne Miller Thidiazuron-Diuron 4.5SC February 28, 2007 page 3



### 8.) Dermal Sensitization Study in Guinea Pigs (Beuh/er Method); Guideline Reference No. 870.2600 (2003)
47070608 

### Laboratory Study No. 19608 MRID No.

____ _

Throughout the data outlined above, you will find references to Micro Flo Company LLC. Arysta LifeScience purchased the assets of Micro Flo Company LLC (EPA Co. No. 51036) in April, 2006. This project was started prior to the purchase by Arysta LifeScience.

The enclosed application should qualify as PRIA Category R31, as this is a new product, does not qualify for Fast Track Review and includes product chemistry and acute tox to be reviewed.

Please contact the undersigned at 901-432-5118 or bye-mail at bill. washburn@arystalifescience.com if you have any questions with respect to this application for registration. Thank you for you time and assistance in the registration of this product.
Sincerely,

Bill Washburn Regulatory Affairs Manager

### Pages 117-119 - *Confidential Statements of Formula may be entitled to confidential treatment*