1

EPA Registration Number 

66330-364 
~_ 2

66330-364 lillilli/ll Ililllllllllllil 

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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 
4

! 

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) 
5

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. 
6

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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 
7

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. 
8

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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: 

DFr - 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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. " 

» • 

, . ".» . . 

, 

" ". 

, . . , 

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

Page I 
9

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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. 

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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. 

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RED + 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. 

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RED + 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. 

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RED + 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 

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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 7 
15

RED + 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 8 
16

DIAZURON-DIURON SC 

OTTON DEFOLIANT 

or Agricultural Use Only 

2,3-thidiazol-5-ylurea* .......................... .36.06% 

yl)-I,I-dimethylurea* ............................ 18.04% 

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

....................................................... 100% 

n and 1.5 lb. Diuron per gallon 

UT OF REACH OF CHILDREN 

CAUTION 

ta, busque a alguien para que se la explique a usted 

s label, find someone to explain it to you in detail.) 

FIRST AID 

ediately call a poison control Center or doctor for 

ment advice. 

ot induce vomiting unless told to do so by a poison 

ol center or doctor. 

 person sip a glass or water if able to swallow. 

anything mouth to an 

 eye open and rinse slowly and gently with water for 

0 minutes. 

ove contact lenses, if present, after the first 5 

tes, then continue rinsing. 

a poison control center or doctor for treatment 

e 

bable mucosal damage may contraindicate the use 

HOT LINE NUMBER 

r label with you when calling a poison control center 

ent. 

: 

NY MEDICAL ASSISTANCE CALL: 1-866-

GENCY: Spill, leak, fire, exposure, or accident 

-9300 

R ADDITIONAL PRECAUTiONS AND USE DIRECfIONS 

C (364-02(607) AD092107 RED + PR 2007-4 (CICHlI).doc 

RED + PR Notice 2007-4 

PRECAUTIONARY STATEMENTS 

HAZARDS TO HUMANS AND DOMESTIC ANIMALS 

CAUTION 

Harmful ifswaUowed. Causes moderaie eye irritalion. Avoid conlacl wilh eyes or 

clolhing. Wash thoroughly wilh soap and water after handling and before eating, drinking, chewing gum, or using lobacco .. 

ENVIRONMENTAL HAZARDS 

Do not apply direclly 10 waler, or to areas where surface water is presenl or to inlertidal 

areas below the mean high waler marie Do nor contaminate waler when disposing of equlpmenl washwaler or rinsale. 

This product may conlaminate waler through drift of spray in wind. This product has a high potential for runoff for several months or more after appHcation. Poorly draining soils and 

sob with shallow water tables are more prone 10 produce runOff that contains this product 

A level, well-mainlained vegetative buffer strip between areas to which this product is 

applied and surface water features, such as ponds, streams, and springs, will reduce the 

polential for contamination of water from runoff. Runoff of this product will be reduced by 

avoiding appfications when rainfall is forecast to occur within 48 hours. Sound erosion 

control practices will reduce this producl's contribulion to surface water conlamination. This 

product has properties and characteristics associated wllh chemicals delected in ground 

waler. Use of this chemical in areas where soils are permeable, particularly where the waler 

table is shallow, may result in ground waler conlaminalion. 

DIRECTIONS FOR USE 

It is a violalion of Federal law to use Ihis product ill a manner inconsistcnt with its 

labeling. 

Do nor make applications of this product that may conlacl workers or oliler person eilher 

by drift or direclly. Protected handlers only are allowed in Ihe area during application. 

Consult your State or Tribe agency responsible for pcslicide regulalions for any specific 

recommendation. 

STORAGE AND DISPOSAL 

Do not contaminale waler, food, or feed by slorage or disposal. PESTICIDE STORAGE: Store this product in a cool, dry place in ils original container 

only. Container should be closed when not in use. Do nol expose the product 10 open 

flame excessive heal. Siore in original container and keep closed. 

PESTICIDE DISPOSAL Peslicide wasles are aculely hazardous. Improper disposal of 

excess pesticide, spray mixlure, or rinsate is a violation of Federal law. If Illese wastes 

cannol be disposed of by use according to label inslruclions, coni act your State Pesticide or Enviromnenlal Conlrol Agency, or the Hazardous Waste representalive at Ihe nearesl 

EPA Regional Office for guidance. 

To Conlain a Spill: Absorb liquid by covering it wilh cat litter, commercial clay, lime, 

sand, sawdust, or soda ash. Once absorbed, bury Ihe cleaning materials and cleanse the 

spill area wilh a dclergenl and water solulion. 

CONTAINER DISPOSAL: 

Nonrefillable Containers equal to or less than 5 gallons: Nonrefillable container. Do not 

reuse or refill this container. Triple rinse conlalner (or equivalenQ promptly after emplying. 

Triple rinse as follows: Empty Ihe remaining conlenls into applicallon equipment or a mix 

tank and drain for 10 seconds after the flow begins to drip. Flilihe contalner:v. full willl 

Page 9 
17

econds. Pour rinsate into application equipment or a mix 

or disposal. Drain for 10 seconds after the flow begins to 

more times. 

er than 5 gallons: Triple rinse as folloWS: Empty the 

n equipment or a mix tank. Fill the container Y. full wllh 

ures. Tip container on lis side and roll it back and forth. 

volution, for 30 seconds. Stand the container on its end 

mes. Turn the container over onto its other end and tip it 

mpty the rinsate into application equipment or a mix tank or 

osal. Repeat this procedure two more times. 

r puncture and dispose of in sanitary landfill, or by other 

d local authorifies. 

efill this container with pesticide only. Do not reuse this 

Cleening the container before final disposal Is the 

sing of the container. Cleaning before refilling Is the 

ean the container before final disposal, empty the 

ainer Into application equipment or mix tank. Fill the 

th water. Agilate vigorously or recirculate water with the 

p rinsate into application equipment or rinsate collection 

edure two more times. 

 

Manufactured for: 

Al)'sta LifeScience North Amerrca, LLC 

15401 Weston Parkway, Suite ISO 

Cal)', NC 27513 

C (364-02t607) AD092107 RED + PR 2007-4 (Clean).doe 

RED + PR Notice 2007-4 

Page 10 
18

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. 
19

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 
20

"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 
21

) 

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 
22

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 

*Product ingredient source information may be entitled to confidential treatment*
23

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 
24

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 

470706-01fMSDS) &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· hysical an d C . hemlca 1P 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 
25

.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 
26

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 
27

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 (LCso>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 
28

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. 
29

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

Product Manager: Joanne Miller / 23 Reviewer: Jolene Trujillo 

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 
30

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 .' / . 

Marianne Lewis, Biologist j i / 

. '~\1 .' • 

Product 

Special Review 

Reregistration 

and Reregistration 

Branch r \; 

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% 
31

) 

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. 

, ,>~ • 

. ",-,"-
32

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 66330M 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 
33

--JlHOll\wiliJlll- Ulu!L!lrJ I.\.S Sc.., Page 1 014 

United States Environmental Protection 10MB Approval 2070-0 107 

Agency Washington, D.C. 20460 OMBApprovai2070·Q057 

REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE 

 Ink. Please read carefully the attached instructions and supply the information requested on this fonn. 

12. Case # and Name 3. Dale iIhd Type Of DCI and Number 

H AMERICA CORPOR} 4092 Thidiazuron 

UITE 150 

Tille 

EPA Reg. No. 66330-364 

Progress 

Reports 

LLC. 

6. Use 

Pattern 

08-May-2008 

PRODUCT SPECIFIC 

lD # PDCI-120301-26085 

7. Test 

Substance 

8. Time 

Frame 

(Monlhs) 

BIB/OS 

'. Registrant 

Response 

f3. Pho", N'mber qOi' 432' 5 II & 
34

United States Environmental Protection 

Agency Washington, D.C. 20460 

EQUIREMENTS STATUS AND REGISTRANT'S RESPONSE 

ERICA CORPORI 

150 

on 1his page 

and supply 

2. Case # and Name 

4092 Thidiazuron 

EPA Reg. No. 66330-364 

Progress 

Reports 

2 13 

requested on 

6. Use 

Pattern 

f6v 

Page 2 of4 

OMB Approvat2070-0W7 

OMB Approvat2070-0057 

3. Date and Type at DCI and Number 

/. 

OS-May-20OB 

PRODUCT SPECIFIC 

10 # PDCI-120301-260S5 

7. Test 

Substance 

Date 8(8(08 

B. TIme 

Frame 

(Months) 

Ip 

G 

'", 
35

United States Environmental Protection 

Agency Washington, D,C. 20460 

REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE 

Page 3 014 

OMB Approvat2070·0t07 OMB Approvat207Q.0057 

n ink. Please read carefully the attached instructions and supply the information requesfed on this form. 

H AMERICA CORPORI 

UITE 150 

 Title 

mation on this page 

2. case # and Name 

4092 Thidiazuron 

EPA Reg. No. 66330-364 

(31 ,32) 

, >" 

(44) 

Progress 

Reports 

2 I 3 

6. Use 

Pattern 

3. Date and Type of DCI and Number 

OB-May-200B 

PRODUCT SPECIFIC 

ID # PDCI-120301-26085 

7. Test 

Substance 

Date t'J8!DB 

8. Time 

Frame 

(Months) 

9. 

Response 
36

United States Environmental Protection 

Agency Washington, D.C. 20460 

REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE 

n ink. Please read carefully the attached instructions and supply the intormation requested on this form. 

Page4of4 

OMB Approvat2070-Ot07 

OMB Approval 2070-0057 

2. Case # and Name 3. Date and Type of DCI and Number 

H AMERICA CORPOR} 

UITE 150 

 Title 

mation on this page 

4092 Thidiazuron 

(38,39) 

Progress 

Reports 

6. Use 

Pattem 

08-May-2008 

PRODUCT SPECIFIC 

ID It PDCI-120301-26085 

7. Test 

Substance 

0:.0 1 Date 8(B/08 

8. TIme 

Frame 

(Months) 
37

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) 
38

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. 
39

~ 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.com 
40

a, LLC 

0 

BIBLIOGRAPHY OF SUBMITTED STUDIES 

Thidiazuron-Diuron 4.5SC 

66330-364 

Response to Agency Letter Dated April 13, 2009 

June 18, 2009 

Up and Down Procedure in Rats 27522 870.1100 

Page 1 of 1 

Acute Tox 47783901 
41

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 
42

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.com 
43

ca, LLC 

0 

BIBLIOGRAPHY OF SUBMITTED STUDIES 

Thidiazuron-Diuron 4.5SC 

66330-364 

Response to Agency Letter Dated April 13, 2009 

June 18, 2009 

 Up and Down Procedure in Rats 27522 

Page 1 Of 1 

Acute Tax 47183901 
44

• , 

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 

Label o Container 

4. , 

2.5 gat, 5.0 gal., 

, 

and 30 gal. ~ On Label 

, ~ 100' lP""'~ 6. h Label i , 10 Pcod," , U Olh". 

. , ... Section ~ IV •••• 

1. C",ta~ Poo' , ~. ; 

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) 

"""" , .' . •••• 2. 

~;~~LATORY MANAGER 

, • > • , • 

, .. . • • 4. Typ" N,m, 5. D,,, , ~ .. BILL' June 18. 2009 

, (R"', ,.,,,, il , , 'Copy 
45

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 

first·Class Mail 

Postage & Fees Paid USPS 111111 Permit No. G-10 

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

-

USEPA/ OPPTS/ OpP! sRim 

Ari'e1 Rios Bldg .. , 

1:200' Pennsyi,~~ni~ .,-Av.~:~~i"e, NW 

I, 

' Washington~ :DC 2-0460 ' 

MC· 75o'8P , r "-:';" , 

0_' , , "'-'" 

') 

I •• ,. III 1111/ .. J.IIII JlII.'III.1 
46

Certified lVI~il. Provides: 

-AmaJllrl'J1 ,it , ., • A Unique idsnrifler for your matlpiece 

• A reCOrd of delivsry kept by the Postal Sel'\rice for two years 

importallt Reminders: 

• Certified Mall may ONLY be: combined with First-Class Maile Or Pnori!y Mall®. 

• CfJrtif)ed Mall is IIOt avaitabte for any cla$S of intemational mail. 

• NO INSURANCE COVERAGE IS PAOVtOEO Wilh Certified Mait. For valUables, please COOSlder InsUred or Recgistered Mail. 

• Foran addillonal fee, a Return Reoelfltmay be requested to Provide proof of 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 eooOJsement authorized "ResllictedDelivery". agent Advise the Clerkar mark the ma~pjece with the 

• /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 r. Bill Washburn 

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 
47

\ 

, 

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 
48

) 

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. 
49

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.com 
50

a, LLC 

0 

BIBLIOGRAPHY OF SUBMITTED STUDIES 

Thidiazuron-Diuron 4.5 SC 

66330-364 

Data Call-In 

January 10, 2009 

Thidiazuron-Diuron 4.5SC with 

ristics MI-0604 OPPTS I Group A- 830.6317 Product 

Page 1 of 1 

47641101 
51

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.com 
52

Page 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 
53

\ 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.ccm 
54

Arysta LifeScience North America, LLC 

15401 Weston Parkway, Suite 150 

Cary, North Carolina 27513 

. BIBLIOGRAPHY OF SUBMITTED STUDIES 

Product Name: Thidiazuron-Diuron 4.5 SC EPA Registration Number: 66330-364 

Purpose of Submission: Data Call-In 

Date of Submission: January 10, 2009 

1 of 1 Storage Stability of Thidiazuron-Diuron 4.5SC with Corrosion Characteristics MI-0604 830.6317 I Product 
55

Please 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 

" 

, . 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 - III 

, I ,II 

~' , , ~'" Solubl, , , ",-,' YP" y~' 

~. ~~s y" Melal 

No ,,~ Plastic 

~;~;;; NO,p" No. poe Glass 

*Certification must wgl. Paper 

be, 

!c [g] Label o Container 

4. ""',S) 

2.5 

",wil' 

gal., 5.0 gal., 

, 

and 30 gal. _~ 

. 

On Label 

'on.o,,' ~ 

I 00 Ii !product 

6. , I 's Affi"d to Product , U Olh" 

' .. ": 

Section ~ IV 

1. Coo,",,, I .. ,b, ' " to procoss this, 

N~~~L WASHBURN I T'tI~EGULATORY MANAGER c;;;-;j , ~~. ,"OClU" Aeo' 

• 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~ , 

',',w: ' :-. ,~. 

2. , 

~~~~LATORY MANAGER 

, 

b~ ( ,""" L. 0, , , , , • , , " 

~'L~:;;~~'BURN o. "'" , , 

1110109 ". , , , 

EPA F'nn 8570·1 (Roy. 8.94). ,eo t WMo-l , ve, , ) ret!,", •. t tCopy 

, , ,~ 
56

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

401 M Street, S.W. 

Form Approved OMB No. 2070-0060 

WASHINGTON, D.C. 20460 

"'" I'UU"'" ,,,,,,,,UIUII!,J UUIU"'" IU' U ",. <AJ .. _vuy,. _ ..... _., 

fies, including lime for reading the instructions and 

or reducing the burden to; Director, OPPE' • ;0' (2-137), u:s. Environmental-Protection Agency, 4Ul M ::ilreet, >:>.VV., vv8smnglon, u\.,; O!U'ItJu. 

DATA MATRIX 

EPA Reg. No.lFile Symbol 

''''''' ... Product 

ca, LLC, 15401 Weston Parkway, Suite 150, Cary, NC 27513 .uIlIRON 4.5SC 

Study Name MRID Number Submitter Status 

Am sillon, etal 47070601 A sta LifeScience North America 0 

it and ical Characteristics 47070602 sta UfeScience North America 0 

Oral T .. 

cute Derm;: 

Inhalaiion I ( 

Eye Irritation 

Dermallrritalion _A''' __ '' __ 

on" .':Llbmll no 

,Iy version. 

)70603 

--

170604 

'70605 

70606 70607 

70608 

UfeSc· UfeS, 

Arysia 

Name and_Title: 

Bill Washbum,-RegulatoryManager 

IPage10f1 

Nole 

Date 

12/20/2008 

Agency Intornal Usc Copy 
57

oc 

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

401 M Street, S.W. 

WASHINGTON, D.C. 20460 

the' 

. Director, 

DATA MATRIX 

EPA Reg. No.lFile Symbol 66330·364 

ca, LLC,-15401 Weston,Parkway, Suite 150, Cary, NC 27513 

Nama 

,:,-" Bill Washburo,:Regulalory Manager 

-

.. ,Iy Paper vers;oo, 

Form Approved OMB No. 2070-0060 

or any other aspect 

M Street, S.W., Washington, DC 20460. 

0' 1 

Date 

12/20/2008 

Agencyrniimal U$e Copy 
58

.. .•. ~.~ ~~-

- 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 . , 
59

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 

'"" , 

" 

*Product ingredient source information may be entitled to confidential treatment*
60

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 
61

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 N2

, 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." 
62

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. 
63

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. 

" . , " , " 

, , 

, " , " 

,., , 

, , , " " 

, , " 

, " 

'" , 

'" , 

, " 

filename: TIlidiazuron·Diuron 4.SSC (xxx-Ol1607) U330-36'; Page 1 , , , 
64

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 

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65

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 3 
66

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 

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 4 
67

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 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 5 
68

IMPORTANT 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 6 
69

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. 

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 7 
70

THIDIAZURON-DIURON SC 

COTTON DEFOLIANT 

For Agricultural Use Only 

ACTIVE INGREDIENTS: 

111idiazur0I1: N-phenyl-N' -1,2,3-thidiazol-5-ylurea * ........................... 36.06% 

Dillron: 3-(3,4-dichlorophenyl)-I, I-dtmetltylurea * ............................ 18.04% 

Other Iltgredients: .................................................................. .45.90% 

TOTAL ..................................................................... 100% 

3 lb. 'Chidiazuron per gaOon and t.5 th. DiurOIl per gaUon 

KEEP OUT OF REACH OF CHILDREN 

CAUfION 

Si listed no entiende la etiqueta, busque a alguien para que se la explique a usted 

en detalle. 

(If yon do not nnderstand this label, find someone to explain it to you in delait.) 

FIRST AID 

IF SWALLOWED Immediately call a poison control center or doctor for 

treatment advice. 

Do not induce vomitmg 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 by moulh 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 rmsing. 

Call a poison control center or doctor for treatment 

advice 

NOTE TO PHYSICIAN: Probable mucosal damage may contraindicate the use 

of .astric 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, 

• Transportatkllt or spHl, call CHE!>4TREC 800-424-9300. • Human health, 800-832-HELP (4357). 

• Animal health, call ASPCA at 800-345-4735 

SF.E AITACtlED BOOKLET FOR ADDITIONAL PRECAUTtONS AND USE DIRECTIONS 

Filcl1ol\lc: ThidiaZllrol1-Diuroll 4.5SC Ixxx-02 (607) 

PRECAUTIONARY STATEM

HAZARDS TO HUMANS AND DOME

CAUTION 

Hannful if swallowed. Causes moderate eye irritation. A 

clothing. Wash thoroughly with soap and water after han

chewing gum, or using tobacco .. 

ENVIRONMENTAL HAZA

Do not apply directly to water, or to areas where surface w

areas below the mean high water mark. Do not contamina

equipment or disposal of equipment washwaters. Do not 

favor drift from treated areas. 

DIRECfIONS FOR US

It is a violation of Federal law to use this product in a man

labeling. 

Do not make applications of this product that may contact 

by drift or directly. Protected handlers only are allowed i

Consult your State or Tribe agency responsible for pestici

recommendation. 

STORAGE AND DISPOS

Do not contaminate water, food, or feed by storage or disp

PESTICIDE STORAGE: Store this product in a cool, dry 

only. Container should be closed whcn not in use. Do no

flame excessive heat. Store in original container and keep 

PESTICIDE DISPOSAL: Pesticide wastes are acutely ha

exccss pesticide, spray mixture, or rinsate is a violation o

cannot be disposed of by use according to label instructio

or Environmental Control Agency, or the Hazardous Was

EPA Regional Office for guidance. 

To Contain a Spill: Absorb liquid by covering it with cat 

sand, sawdust, or soda ash. Once absorbed, bury the clca

spill area with a detergent and water solution. 

CONTAINER DISPOSAL: Triple rinse (or equivalent); t

reconditioning, or puncture and dispose of in sanitary lan

approved by State and local authorities. 

DO NOT REUSE EMPTY CON

EPA Reg. No. 663JO-xxx EPA Est. No. 51036-GA-00I 

ADxxxxx 

NET CONTENTS, __ _ 

Page 8 

Manufactured b

Arysta LifeScie

15401 Weston P

Cary, NC 27513 
71

UNITED 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) 
72

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% 
73

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 
74

( 

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. 

3 
75

PC 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. 

4 
76

PC 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 

5 
77

PC 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 

6 
78

PC 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. 

7 
79

PC 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 
80

) 

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. 

9 
81

PC 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 Le50 

ofThidiazuron-Diuron 4.5SC is greater than 2.03 mg'L in male and female rats. 

10 
82

pC 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. 

11 
83

PC 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. 

12 
84

PC 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 cm2 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 
85

) 

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. 

14 
86

PC 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. ' 

15 
87

PC 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. 
88

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 LCso > 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 17 
89

SUBJECT: 

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. 
90

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 

2 
91

Enforcement 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 
92

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. 
93

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 
94

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 
95

Ombudsman at (703) 305-6249. 
96

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: 
97

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 
98

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 

-----
99

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 

~Q,Q~ Regulatory Affairs Manager 'j: . , .. .. , 4. Typed Name . , " , . . 5. Date ; : . , 

" Bill Washburn February 28,2007 " "i' , 

, " . .. EPA Form 8570-1 (Rev. 8 94) PrevIOus edItIons are obsolete Whlte- EPA FIle Copy (ongmal) 'V .p)lp}'o < ApplJcant Copy 

, " , , , 
100

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. 
101

- UNITED STATES ENVIRONMENTAL PROTECTION AGENCY Form Ap

0 401 M Street, S,W. WASHINGTON. D.C. 20460 

Paparwork Reduction Act Notice: The public reporting burden for this collect[on of information Is estimated to average 0.25 hours per response for registration activities 

reregistration and special review activities, Including lime for reading the instructions and completing the necessary forms. Send comments regarding the burden estimat

of Inform ail on, Including suggestions for reducing the burden 10: Director, OPPE Information Management Division (2137). U.S. Environmental Protection Agency, 401 M 

Do nol send the form 10 [his address. 

DATA MATRIX 

Date February 27. 2007 EPA Reg. No.lFile Symbol 66330- 

AppUcant'sJRegislrant's Name & Address: Product Arysta LifeScienco North America Corp., 15401 Weston Parkway, Suite 150, Cary. NC 27513 THIDIAZURON-DIURON 4.5SC 

Ingredient(s): Thidlazuron, Diuron 

Guidenne Reference Number Guideline Study Name MRID Number Submitter Status 

Product Chemistry 

830.A Product Identity and Composition, etal Arysla LifeScience North America Submit 

i 830.B Physical and Chemical Characteristics Arysla LifeScience North America Submit 

Acute Toxicology 

870.1100 Acule Oral Toxicit UfeScience North America Submit 

870.1200 Acute Dermal T oxicJ!y_ &lsta LifeScience North America Submit 

870.1300 Acute Inhalation Toxicity LifeScience North America Submit 

870.2400 Prima E e Irritation A sta UfeScience North America Submit 

870.2500 Primary Dermallrritalion Arysla LifeSclence North America Submit 

870.2600 Skin Sensitization Arysta LifeScience North America Submit 

Generic Data 

Cite-All BayerCropScience LP 

EPA Co. No. 264 

Chemtura USA Corporation 

EPA Co. No. 400 

Makhteshim-Agan of N. A. 

EPA Co. No. 66222 

Cite-All Spray Drift task Force 

EPA Co. No. 66607 

: '- - Outdoor Residential Exposure TF 

". - EPA Co. No. 71754 

- 3:::ite-'\1I .: . -. Agricultural Reentry TF 

.. -

-

- - EPA Co. No. 71755 

. 

Nations Ag II, LLC 

. EPA Co. No. 72167 u _ ". 

:--: : Ciw:AII . . . SRM Chemical, Ltd. Co. 

.. . 

. 

. 

.. . . . . EPA Co. No. 73631 

Cfte-AII 

. 

" . Ag Handlers Exposure TF 

EPA Co. No. 75234 

Signature Name and Title: 

Bill Washburn. Regulatory Affairs Manager 

--

PA Form 8570_35 [S·S7) Eleclronlc and Paper versions available. Submil only Pape> version. 
102

Form 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 copy 

*Product ingredient source information may be entitled to confidential treatment*
103

F A ormpproved 0 MB 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 Februarv27,2007 

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"..itYlnatJ 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. 
104

.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 1 
105

PRECAUTIONARY 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 2 
106

Rotation 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 3 
107

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 

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 4 
108

DOSAGE 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) PageS 
109

IMPORTANT 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 6 
110

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. 

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 7 
111

THIDIAZURON-DIURON SC 

COTTON DEFOLIANT 

For Agricultural Use Only 

ACTIVE INGREDIENTS: 

Thidiazuron: N-phenyl-N' -I ,2,3-thidiazol-5-ylurea* .......................... .36.06% 

Diuron: 3-(3,4-dichlorophenyl)-I, I-dimethylurea* ..... _ ...................... 18.04% 

Other Ingredients: .................................................................. .45.90% 

TOTAL ................................................................. .... 1000/0 

C0111ains 3 lb. Thidiazuron per gallol\ and 1.5 lb. Diuron per gallon 

KEEP OUT OF REACH OF CHILDREN 

CAUTION 

Si nsted no entiende la etiqueta, busque a alguien para que se la expHque a usted 

en detalle. 

(lfyoll do not understand this label, find someone to explain it to you in detaiL) 

FIRST AID 

IF SWALLOWED Inmlediately 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 ifable to swallow. 

Do not give by mouth to an unconscious perSon 

IF IN EYES: Hold eye open and rinse slowly and gently with water for 

15-20 nunutes. 

Remove contact lenses, if present, after the first 5 

mhmtes, 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 

I·lave the prodl1ct container or label with you when calling a poison control center 

or doc lor ot going for treatment. 

EMERGENCY NUMBERS: 

• Transportation or spill, call CHEIv!TREC 800-424-9300. • Human healdl, 800-832-HELP (4357). 

• Animal health, call ASPCA at 800-345-4735 

SEE ATTACIIED IJOOKLET FOR ADDITIONAL PRECAUTIONS AND USE DIRECTIONS 

l'ill'nal11C: Thidiazuron-DinfOn 4.SSC (xxx-OZI 607) 

PRECAUTIONARY STATEM

HAZARDS TO HUMANS AND DOMES

CAUTION 

Harmful if swallowed. Causes moderate eye irritation. Av

clothing. Wash thoroughly with soap and water after hand

chewing gum, or using tobacco .. 

ENVIRONMENTAL HAZA

Do not apply directly to water, or to areas where surface w

areas below Ihe mean high water mark. Do not contamina

equipment or disposal of equipment washwaters. Do not a

favor drift from treated areas. 

DIRECTIONS FOR USE 

It is a violation of Federal law to use this proouct in a man

labeling. 

Do not make applications of this product that may contact 

by drift or directly. Protected handlers only are allowed in 

Consult your State or Tribe agency responsible for pesticid

recommendation. 

STORAGE AND DISPOSA

Do not contaminate water, food, or feed by storage or disp

PESTICIDE STORAGE: Store this product in a cool, dry 

only. Container should be closed when not in use. Do not 

flame excessive heat. Store in original container and keep 

PESTICIDE DiSPOSAL: Pesticide wastes are acutely haz

excess pesticide, spray mixture, or rinsate is a violation of 

cannot be disposed of by use according to label instruction

or Environmental Control Agency, or the Hazardous Wast

EPA Regional Office for guidance. 

To Contain a Spill: Absorb liquid by covering it with cat 

sand, sawdust, or soda ash. Once absorbed, bury th e dean

spill area with a detergent and water solution. 

CONTAINERDISPQSAL: Triple rinse (or equivalent); th

reconditioning, or puncture and dispose of in sanitary land

approved by State and local authorities. 

DO NOT REUSE EMPTY CON

EPA Reg. No. 66330-xxx EPA Est. No. 51036-GA-001 

ADxxXxx 

NET CONTENTS: __ _ 

Page 8 

Manufactured by 

Arysta LifeScien

15401 Westoll P

Cary, NC 27513 
112

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. 
113

· 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 
114

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_Je_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 
115

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 
116
Pages 117-119 - *Confidential Statements of Formula may be entitled to confidential 

treatment*