REGISTRATION

66330-334 

Vol.3 
1

Material Sent for Data Extraction 

Reg # __ .::::&;..::::0'-.;3::::.:::.3.::-°_-_3_--':'_Lf~ 

Descri pti 0 n: ______ ~~e'--'re;:::,'}j.:..:~ s=--~2.-...C_+w:--,-'.:-.-· _______ _ 

IZI Material(s) Sent to Data Extraction Contractors: 

New Stamped Label Dated 4/::2..0/ II 

o Notification Dated ____ _ 

yr New CSF(s) Dated ____ _ 

o Other: _________ _ 

Decision #: __ 3_f1_3_I_G---,-I __ 

Other Action/Comments: 

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: Mindy Ondish 

Phone: 703-605-0723 Division: RD/PM Team 25 

Date: ____________ y---'-/~~i~/~I~I ______________ _ 
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$~€.OS"i, U.S. ENVIRONMENTAL PROTECTION AGENCY EPA Registration Date of Issuance: 

i Q ~ Office of Pesticide Programs Number: 

Registration Division (7504P) 

\~IU) Ariel Rios Building /.0, 2 6 2011 66330-334 Ii ii' 

~LPM!¢ 1200 Pennsylvania Ave., NW 

Washington, D.C. 20460 

NOTICE OF PESTICIDE: Term of Issuance: Unconditional L Registration 

l Reregistration Name of Pesticide Product: 

(under FIFRA, as amended) Thidiazuron 4 SC 

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 Divisi6n"priodo use of the label in commerce. In any correspondence on this product'always referlo the· above EPA registration 

number, ',,' 

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

Fungicide and Rodenticide Act. Registration is in no way to be construed as an endorsement or recommendation of this product by the Agency. 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 Ils use if it has been covered by others. 

EPA received a label amendment request submitted on April 20, 2011. EPA grants this request 

under the authority of section 3(c)(5) of the Federal Insecticide, Fungicide and Rodenticide Act, as 

amended. With this accepted labeling, all requirements set forth in the Reregistation Eligibility 

Decision (RED) for Thidiazuron have been satisfied. Therefore, EPA reregisters the product 

listed above. This action is taken under the authority of section 4(g)(2)(c) of the Federal 

Insecticide, Fungicide, and Rodenticide Act, as amended. Reregistration under this section does 

not eliminate the need for continual reassessment of pesticides. EPA may require submission of 

data at any time to maintain the registration of your product. 

Submit one (1) copy offinal printed labeling. Amended labeling will supersede all previously 

accepted labels. A copy of your label stamped "Accepted" is enclosed for your records. Products 

shipped after twelve (12) months from the date of this Notice or the next printing of your label, 

whichever occurs first, must bear the new revised label. 

If you have any questions regarding this Notice, please contact Mindy Ondish at (703)605-0723 or 

at ondish.mindy@epa.gov. 

S;,,,'",e of Aoo",;o, ~ Date: 

Kathryn V. Monta ue . t/;;Vv(YJ V {nanfj Product Manage 2 l1PR 2 6 2011 

Herbicide Branch 

Registration Division (7505P) 

EPA Form 8570·6 
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THIDIAZURON 4 SC 

COTTON DEFOLIANT 

For Agricultural Use Only 

ACTIVE INGREDIENT: Thidiazuron (N-phenyl-N'-1 ,2,3-thiadiazol-5-ylurea)* ....................... 42.4% 

OTHER INGREDIENTS: ......... ...... ...... ................................. . .............................. 57.6% 

"Not less than 4.0 Ibs. of thidiazuron per gallon TOTAL ......• 100,0% 

KEEP OUT OF REACH OF CHILDREN 

CAUTION - CAUCION 

Si usted no entiende la etiqueta, busque a alguien para que se la explique a usted en detalle. ([fyou do not 

understand this labe~ find someone to explain it to you in detail.) 

FIRST AID 

IF ON SKIN • Take off contaminated clothing. OR Rinse skin immediately with plenty afwater for 15-20 minutes. CLOTHING: • 

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

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

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

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

IF INHALED: • Move person to fresh air. 

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

preferably mouth~to·mouth if possible. 

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

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

SWALLOWED: 

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

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

• Do noU;:jlve an.Ytbing ~ mouth to an unconscious p_erson. 

HOT LINE NUMBER 

EMERGENCY TELEPHONE NUMBERS: 

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

treatment. 

FOR 24-HOUR EMERGENCY MEDICAL ASSISTANCE CALL: 1-866-303-6952 

FOR CHEMICAL EMERGENCY: Spill, leak, flre, exposure, or accident call CHEMTREC 1-800-424~ 

9300. 

SEE INSIDE (SIDE PANEL) FOR ADDITiONAL PRECAUTIONS AND USE DIRECTION S "';;;-'" 

EPA Reg. No. 66330-334 EPA Est. NJ 1-1. 0 C EPT E D 

AD 081705 

NET CONTENTS: __ _ 

Manufactured For: 

ARYSTA LlFESCIENCE NORTH AMERICA, LLC 

15401 Weston Parkway, Suite 150 

Cary, NC 27513 

lPC; 2 6 20ir 

Under tho Fod:mu lWecilclde, 

Pung!.olde, and Rodentlolde Ad, 

M Oltu!m&!d, tOI"" the pe.lJl;ielde 

\""\1;.;i::toroo. unool' 

l'~:'k!!~ No 0.Se.3. 1...\ 

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PRECAUTIONARY STATEMENTS 

HAZARDS TO HUMANS AND DOMESTIC ANIMALS 

CAUTION 

Harmful if swallowed, inhaled, or absorbed through the skin. Avoid breathing spray mist. Avoid contact with skin, eyes, 

and clothing. Do not contaminate food or feedstuffs, 

PERSONAL PROTECTIVE EQUIPMENT (PPE) 

All mixers, loaders and applicators must wear: 

• Long~sleeved shirt 

• Long pants 

• Shoes and socks 

• 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 

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)], 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/PPE immediately if pestiCide gets inside. Then wash thoroughly and put on clean 

clothing. 

• Remove PPE immediately after handling this product. As soon as possible, wash thoroughly and 

chanae into clean cloth ina. 

ENVIRONMENTAL HAZARDS 

Do not apply directly to water, or to areas where surtace water is present, or to intertidal areas below the mean high 

water mark. Do not contaminate water when disposing of equipment washwater or rinsate. Do not apply when weather 

conditions favor drift from treated areas. 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 product 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 forecasted to occur within 48 hours. Sound erosion control practices w~l reduce 

this product's contribution to surtace water contamination. 

This chemical 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 groundwater 

contamination. 

PHYSICAL OR CHEMICAL HAZARDS 

This product is incompatible with strong oxidizing agents such as nitrates, chlorine bleach or hydrogen peroxide. 

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DIRECTIONS FOR USE 

It is a violation of Federa! 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 persons 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 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 soil or water, is: 

• Coveralls 

• Chemical-resistant gloves made of any waterproof material 

• Shoes_plus socks 

PRODUCT INFORMATION 

THIDIAZURON 4 SC, a harvest aid compound, is used for leaf removal prior to cotton harvest. THIDIAZURON 4 SC 

can be used in aircraft or ground equipment and is easily dispersed in water. Several days may pass before effects of 

treatment may be observed. Low temperature and other adverse conditions may require longer times and/or higher 

dosages for adequate defoliation. 

THIDIAZURON 4 SC diminishes lint staining at the time of harvest and ginning by slowing regrowth. 

USE RESTRICTIONS 

This product is not to be applied through any type of irrigation system. 

The efficacy of THIDIAZURON 4 SC will be diminished if rainfall occurs within 24 hours post application. 

Foliage from treated plants or gin trash is not to be fed to livestock. Do not use immature crops for feed. 

Rotation to the following crops re quires the minimum of the specified periods below after the last application of 

THIDIAZURON 4 SC. 

small grains, sorghum, corn, or root crops (except carrots, onions or sugar beets) '" ........ two (2) weeks 

legumes (including alfalfa) or leafy vegetables (except lettuce and spinach) .................... two (2) months 

sugar beets ..................................................................................................... .four (4) months 

carrots, onions and spinach .................................... '" ........................................... nine (9) months 

lettuce ........................ ONLY when soil has been deep-plowed (12-15 inches) ............ nine (9) months 

To avoid defoliation of a nd injury to other plant species. prevent spray drift from con tacting crops other than 

mature cotton. 

Mixtures with organophosphate products can increase non-target crop phytotoxicity. Exercise additional care when 

lettuce, citrus, cantaloupes or any other edible crops are adjacent to THIDIAZURON 4 SC treated fields. 

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RESTRICTIONS TO LOWER SPRAY DRIFT POTENTIAL ONTO NONMTARGET CROPS 

Under windy weather conditions, applications of TH1D1AZURON 4 SC may drift to nonMtarget crops. 

The following restrictions will help reduce drift potential: 

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

THIDIAZURON 4 SC. 

• Nozzle pressures of 20 - 30 psi are 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. 

• In general, a decrease in droplet size or increase in wind speed at the time of application will result in risk to nontarget organisms. Alternatively, if droplet size is coarser or wind speeds are lower, exposures due to drift would be 

reduced. 

• Do not apply this product by ground within 100 feet or by air within 0.5 mile of lettuce. 

RESTRICTIONS TO LOWER SPRAY DRIFT POTENTIAL IN THE RIO GRANDE VALLEY OF TEXAS 

The following restrictions will 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 4 SC. If wind speeds are less than ten (10) miles per hour, obselVe local recommendations from 

your State Extension Cotton Specialist 

• Nozzle pressures of 20 - 30 psi are 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. 

• In general, a decrease in droplet size or increase in wind speed at the time of application will result in risk to nontarget organisms. Altematively, if droplet size is coarser or wind speeds are lower, exposures due to drift would be 

reduced. 

• Use the maximum nozzle orifice size that provides appropriate coverage and deposition of this product. 

• CITRUS A REAS: Do not apply THIDIAZURON 4 SC by ground when citrus in flush {burst of new growth as in 

springtime) is within 1/2 mile downwind of the point of application. Do not apply by air when citrus in flush is within 

5 miles downwind of the point of application. 

TIME OF APPLICATION 

THIDIAZURON 4 SC defoliant applications are to be made only on mature cotton plants when the uppermost 

halVestable 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 THIDIAZURON 4 SC at least five (5) days prior to expected halVest date. 

NOTE: The following conditions will determine adequate defoliation with THIDIAZURON 4 SC: 

• Cotton is actively growing 

• High relative humidity 

• Cotton plant leaves are turgid and not desiccated 

CONDITIONS 

Under low nighttime temperatures (below 60°F), this product, when used alone, may provide less than expected 

defoliation and/or regrowth suppression. For best results, apply this product when overnight temperatures will exceed 

60°F two to three days before and after application. 

The effects of THIDIAZURON 4 SC on heat or drought stressed cotton having non-turgid leaves and extremely waxy 

leaf surfaces may include reduced defoliation and reduced regrowth suppression. 

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THJD!AZURON 4 SC AS A FOLLOW UP DEFOLIATION TREATMENT 

Reduced or unsatisfactory defoliation may occur when THIDIAZURON 4 SC is used as a second or follow up 

treatment, except when fonowing a prior THIDIAZURON 4 SC or THIDIAZURON 50WP stand alone or tank mixed 

application with other defoliants. Also, see CONDITIONS. 

CROP OIUADJUVANTS USAGE 

Crop oil concentrates (COC's) or penetrating oils approved for agricultural crops have shown to improve performance 

under low nighttime temperatures (600 - 65°F) and heat or drought conditions. Follow adjuvant label recommendations 

for proper rates. 

Adjuvant usage in the desert Southwest (i.e., Arizona and California) is recommended when applying THIDIAZURON 

4SC. 

ATTENTION: During periods 0 f high temper ature, the use of adjuvants rna y result in the fre ezing an dlor 

desiccation of leaves. As a re suit, the use of such compounds is not recommended during high temperature 

Periods. 

MIXING INSTRUCTIONS 

1. Fi!1 spray applicator tank with at least one half of the water to be used 

2. Start agitation 

3. Add the appropriate volume ofTHIDIAZURON 4 SC 

4. Continue agitation and fill tank with the remainder of the water to be used 

5. Agitation should continue throughout the application 

TANK MIX ADJUVANTS 

To assist in defoliation perfonnance it is recommended, when using a combination of this product and 

organophosphate defoliants in a tank mix, that a compatibility agent or surfactant is also used. Always perfonn a small 

jar test for compatibility before tankMmixing. 

When tankMmixing, only toleranceMexempt products (pursuant to 40 CFR 180.1001) are permitted for use. 

Fo!1ow manufacturers label instructions of the appropriate adjuvant. 

When an adjuvant is to be used with this product, Arysta recommends the use of a Chemical Producers and 

Distributors Association (CPDA) certified adjuvant. 

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APPLICATION 

Use an adequate volume of water with the specified amount of THIDIAZURON 4 SC defoliant to unifonnly and 

completely cover leaves. For ground equipment. apply 10 - 25 gallon per acre and by air, use 3 -10 gallons per acre. 

Maintain agitation during application. 

Do not allow mixed spray solution to stand overnight. 

DOSAGE 

Application Rate: Use O.1251b ai/A (4 fl oz/A). You will be able to make applications to 20-40 acres with one gallon of 

this product. When under low temperatures of 600 

- 65°F, use the higher rate of 0.2 Ib ai/A (6.4 fI ozlA). 

When defoliating rank cotton, two applications are sometimes required for adequate defoliation. Maximum of two 

applications, but not to exceed 0.3 Ib ai/A per year. 

Maximum application rate of a.3lb ai/A per year (9.6 fI ozlA). 

For cutout and mature cotton under normal weather patterns use Thidiazuron 4 SC at 0.05 to 0.10 Ib ai/A. The 0.05 Ib 

rate is most effective when used in a tank mix with other cotton defoliant products. 

Increased rates ofThidiazuron 4 SC above 0.10 Ib of ai/per acre may be needed to defoliate and control regrowth 

during periods of rank growth/high fertilizer conditions, extreme weather conditions, such as extended periods of rain 

and/or low temperatures (60'-65'F) and on full-season cotton varieties. 

To Achieve an Application Use this Amount of Product At the Indicated Rate, One 

Rate of: Gallon of Product Wi!! Treat 

0.07 Ib ai/A 2.3 fI oziA 56A 

0.17 Ib ai/A 5.4 fI oz/A 23.5A 

ARIZONA ONLY: BOTIOM DEFOLIATION 

THIDIAZURON 4 SC can be used to help reduce bon rot and hard lock: caused by moisture retained in the canopy, by 

aiding improved air circulation within the cotton canopy. Base product application timing upon the latest date when 

application equipment will not cause significant crop damage when driving applicator through the cotton crop. 

Application Rate: Use 0.051b active ingredient/acre (1.6 fI ozlA). 

It is recommended to apply THIDIAZURON 4 SC only to the bottom 1/3 of the plant. 

ARIZONA AND CALIFORNIA ONLY: PRECONDITIONING 

When used as a pre-conditioner seven to ten days before application of 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. 

Application Rate: Use 0.05-0.1 Ib active ingredient/acre (1.6-3.2 fl oz/A). 

TANK MIXES OF TH!DIAZURON 4 SC AND ETHEPHON CONTAINING COMPOUNDS 

Improved defoliation and improved opening of mature bolls can be achieved by tank mixing THIDIAZURON 4 SC and 

Ethephon 6TM or its equivalents. For best results, apply to mature cotton plants (See Application Timing section of this 

label). Wait until unopened bolls have reached adequate maturity so as to not affect the desired cotton yield. Certified 

cottonseed producers should consult seed companies as to proper boll and seed maturity requirements for their 

varieties. Low nighttime temperatures (if expected to be below 60°F) can reduce defoliation and decrease regrowth 

suppression. 

Application Rate: Use 0.05-0.125 Ib active ingredient/acre (1.6-4 fl oZ/A) of THIDIAZURON 4 SC along with 1-2 Ib 

active ingredient/acre (32-64 fl oz/A) of Ethephon 6TM. 

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Under conditions of excessive regrowth potential or expected low temperatures, use the higher rates of 

THIDIAZURON 4 SC. When under low temperatures of 60c - 65"F, use the higher rate of 0.2 Ib ai/A (SA fI ozlA). 

TANK MIX OF THIDIAZURON 4 SC PLUS ETHEPHON FOR DEFOLIATION ENHANCEMENT: 

To improve defoliation, you may use lower rates (high enough to promote boll opening) of Ethephon em or its 

equivalents tank: mixed with this product. Following such an application, Ethephon 6Th! can still be used to promote boll 

opening. Per year, however, you may use no more than 2.0 Ib ai/acre of Ethephon 6TM (approximately 42 fI oz of 

product) across all applications. Observe all product label directions, recommendations and prohibitions for Ethephon 

6TM, 

Application Rate: Use 0.05-0.125 lb. active ingredient/acre (1.6-4 fl ozlA) of THIDIAZURON 4 SC along with 0.251b 

active ingredient/acre (32-64 fl ozlA) of Ethephon 6TM. 

If excessive regrowth or low temperatures are expected, use the higher rate of 0.2 Ib ai/A (6.4 fl ozlA) of 

THIDIAZURON 4 SC. Maximum application rate of 0.3 Ibs ai/Acre per year. Maximum of 2 applications, but not to 

exceed 0.3 Ibs ai/Acre per year 

TANK MIX OF THIDIAZURON 4 SC WITH TRIBUFOS PRODUCTS (DEF® I FOLEX®) 

When plants to be treated are subject to non-ideal conditions, such as overnight temperatures below 60"F one day 

previous and three days after application, it is recommended to tank mix this product and DEF® 6/FOLEX® 6 EC. This 

combined spray solution will improve regrowth suppression and defoliation. 

Make tank mix applications to mature cotton with at least 60% open bolls to achieve best activity. 

RATE OF APPLICATION forTHIDIAZURON 4 SC - TRIBUFOS TANK MIXES 

THIDIAZURON 4 SC at 1.6 to 4 fluid ounces per acre + DEF® 6 at 0.5 - 2.0 pints per acre. 

THIDIAZURON 4 SC at 1.6 to 4 fluid ounces per acre + FOLEX® 6 EC at 0.5 - 2.0 pints per acre. 

If excessive regrowth is expected, use the higher rates of THIDIAZURON 4 SC. 

ATTENTION: Desiccation may occur when tank mixing organophosphate defoliants and maximum rates of this product 

during extremely high temperatures. 

When under low temperatures of 60" - 65"F, use the higher rates of DEF® 6/FOLEX® 6 EC as specified. 

For tank mix ofTHIDIAZURON 4 SC and DEF® 6/FOLEX®6 EC: 

Follow MIXING INSTRUCTIONS. Following the complete dispersion of THIDIAZURON 4 SC, add the required amount 

of DEF® 6/FOLEX® 6 EC to spray tank. Should an additional application of this tank mix be necessary, be sure to use 

no more than a total of 0.125 Ib active ingredient per acre (4 fl ozlA) of this product. 

Observe all product label directions for use, recommendations, prohibitions and tank mixing compatibility instructions 

for DEF®6 and FOLEX® 6 EC. 

CAMERON, HIDALGO, STARR AND WILLACY COUNTIES OFTHE STATE OF TEXAS: 

THE USE OF A TANK MIXOFTHIS PRODUCT WITH DEF®S OR FOLEX®S EC IS PROHIBITED. 

IMPORTANT CLEANOUT INSTRUCTIONS 

When tank mIXing organophosphate defoliants with THIDIAZURON 4 SC, 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 deaners and cleaning procedures. 

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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 afte cted equipment to capacity with com mercial 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 TH[DIAZURON 4 SC, Such 

improper cleaning could lead to crop damage in later applications. 

Arysta assumes no liability for crop damage 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: This product should be stored at temperatures less than 1000 F. Should this product be 

subject to freezing conditions, this product should be re-mixed prior to use. 

PESTICIDE DISPOSAL: Wastes resulting from the use of this product must be disposed of on site or at an approved 

waste disposal facility. 

CONTAINER DISPOSAL: 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 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 this procedure two more times. Offer for recycling, if 

available, or puncture and dispose of in a sanitary landfill, or by incineration, or if allowed by state and local authorities, 

by buming. If burned, stay out of smoke. 

RETURNABLE/REFILLABLE CONTAINER: 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 a 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 procedure two more times. 

To Return: Do not rinse container. Do not empty remaining formulated product. Do not break seals. Return intact to 

point of purchase. 

To Refill: This container can be refilled by Arysta LifeScience North America, LLC or an Arysta-authorized registered 

establishment. Retum this container to such a site or the point of purchase after use. Examine product packaging 

before refilling, checking for any type of damage, including abrasions, fractures, punctures, or damaged closure 

devices. Prior to transporting this container, inspect for leaks. Inspect for leaks again before and after refilling. Refilling 

of leaking containers is prohibited. 

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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-Iarget 

movement, unconventional farming techniques, the presence of other malerials, the manner of use or application, or other unknown 

factors, all of which are beyond the control of Arysla LifeScience North America, LLC ("Arysla"), 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 WA RRANTIES, 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 OISCL AIM AND SHALL NOT 

BE LIABLE FOR ANY SPECIAL, INCIDENT AL, INDIRECT, OR CONSEQUENTIAL DAMAGES RESULTING FR OM THE USE, 

HANDLING, APPLICATION, STOR AGE, OR DISPOS AL OF TH IS PRODUCT OR FOR DAMAGES IN THE NATURE OF 

PENALTIES, AND THE US ER AND BUYER WAIVE ANY RtGHT THAT THEY MAY HAVE TO SUCH DAMAGES. NO AGENT, 

REPRESENTATIVE ORE MPLOYEEOF ARYSTAI S AUTHORIZEDTOM AKE ANYWARRANTY,GU ARANTEEO R 

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 BUY ER, AND THE 

TOTAL LIABILITY OF ARYSTA, MANUFACTURER, ANO SELLER, SHALL BE LIMITED TO THE PURCHASE PRICE PAID, OR 

AT ARYSTA'S ELECTION, THE REPLACEMENT OF THE PRODUCT. 

Def ® is a registered trademark of Bayer Crop Science 

Ethephon 6Th! is a trademark of Arysta LifeScience North America, LLC 

Folex ® is a registered trademark of Amvac Chemical 

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Follow Up: 

MindyThidiazuron 4 SC Labels (66330-334) 

HAWKINS, Alex to: Mindy On dish 

Cc: "DYKES, Jan" 

Urgent Priority. 

04/20/2011 09:34 AM 

Here are the corrected Thidiazuron 4 SC labels (Clean and Strikeout versions) at long last. I should have 

the Thidiazuron-Diuron SC (66330-344) to you by the end of the day. it is currently undergoing a few 

last minute corrections. As discussed previously, we have not added the resistance management 

language. 

Regards, 

Alex Hawkins 

W. A. Hawkins, Jr., Ph.D. 

Regulatory Manager 

Arysta LifeScience North America, llC 

"111 

919-678-4886/ fax: 919-678-2194 066330-00334.20110413.Thidiazuron4SCcln.pdf 

~'-i ~; 

066330-00334.20110413. Thidiazuron4SCSTK.pdf 
13

( 

~ Re: FW: 66330-334 Thidiazuron 4 SC label comments Cl _~_-.=-="-,-"' __ :cM:::in;;;dLY Ondish to: HAWKINS, Alex 04/06/2011 01 :35 PM 

Alex, 

Thank you for getting to this quickly. In response to your questions: 

1) Resistance management grouping symbol can be omitted from this label if it will be confusing to the 

user. 

2) The buffer restrictions can be removed from the Ag Use box and placed in the Restrictions sections. 

Ideally, the restrictions should be verbatim of what the thidiazuron RED states, so fi you can change the 

statements to match that would be best. 

3) I would prefer "This product is incompatible with strong oxidizing agents such as [list example]." over 

the other statement you proposed. 

Hope that helps, 

Mindy 

"HAWKINS, Alex" MilJdY,'::,We are currently.working on making the ... 

From: 

To: 

Date: 

Subject: 

Mindy ~ 

"HAWKINS, Alex" <Alex.HAWKINS@arystalifescience.com;> 

Mindy Ondish/DC/USEPAlUS@EPA 

04/0512011 05: t9 PM 

FW: 66330~334 Thidiazuron 4 SC label comments 

04/05/201105:19:14 PM 

We are currently working on making the requested corrections to the 

Thidiazuron 4 Sc (66330~334)label (and the Thidiazuron~Diuron SC label; 

66330~344). Upon studying your remarks, I have a couple of comments and a 

question regarding the former. 

First, resistance management language is not appropriate for a cotton 

defoliant product. Unlike conventional herbicides that are applied to control 

weed pests that are capable of developing resistant populations over time, 

defoliants are applied to mature cotton plants to aid in harvest. Weed pests 

are not involved. There is no concern about resistance developing because all 

of the cotton will be harvested and there is no "chemical selection" for 

resistant individuals that could eventually lead to resistant populations. 

Arysta will not add resistance management language on the Thidiazuron 4 SC 

label. 

Second, I have not studied this label before. Bill Washburn left the company 

at the end of May, and I inherited the cotton defoliants that he was 

previously responsible for. In reviewing the draft label, I note that Bill 

added some drift management language inside the Agricultural Use Requirements 

box (at the bottom). This language is a duplication of drift reduction 

language that appears on the next page of the label. I don't think it belongs 

in the Agricultural Use Requirements box, and I'd like to remove it. Is that 

acceptable? 

Regarding your comment about Chemical or Physical Hazards, can you suggest 

what specific remarks might be included under this heading? I've looked at 

the labels of all registered thidiazuron products on PPLS, and none of them 

have this kind of information. Is it sufficient to add a statement such as: 

"This product is incompatible with strong oxidizing agents" or "Keep away from 

incompatible products, such as strong oxidizing agents"? I looked at the 
14

( 

data, and there was an exothermic reaction when the product was combined with 

potassium permanganate. I can use some help here. 

Regards, 

Alex Hawkins 

W. A. Hawkins, Jr., Ph.D. 

Regulatory Manager 

Arysta LifeScience North America, LLC 

919-678-4886 I fax: 919-678-2194 

-----Original Message-----

From: JANIS, Jonathan 

Sent: Wednesday, March 16, 2011 4:34 PM 

To: Ondish.Mindy@epamail.epa.gov; HAWKINS, Alex 

Subject: RE: 66330-334 Thidiazuron 4 se label comments 

Mindy, 

Alex Hawkins handles the Thidiazuron labels for Arysta. 

I will forward this email to him. 

Best regards, 

Jonathan 

Jonathan A. Janis 

Regulatory Manager 

Arysta LifeScience North America 

Mobile- 919.749.1410 

Office- 919.678.4917 

Fax- 919.678.2182 

-----Original Message-----

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

Sent: Tuesday, March 15, 2011 6:14 PM 

To: JANIS, Jonathan 

Subject: 66330-334 Thidiazuron 4 SC label comments 

Mr. Janis, 

I could not reach Bill Washburn so I am redirecting this to your 

attention since you are listed as the contact email for Arysta. 

After review of the draft reregistration label for the subject product, 

the following changes must be made: 

1. Due to the importance of resistance management to a long-term 

2. 

pest-management strategy, it is suggested that resistance management 

grouping symbols and statements be included on the labeling as 

described in PR Notice 2001-5. 

Change the PESTICIDE DISPOSAL phrase to "must be disposed of". 

3. Add a "PHYSICAL OR CHEMICAL HAZARDS" section directly below the 

Environmental Hazards section and place a statement regarding the 
15

incompatibility of the prOduct with other chemicals (e.g. oxidizing 

agents) as evidenced by the Oxidation/Reduction data provided. 

4. Move the GENERAL INFORMATION section on page 2, and the USE 

PRECAUTIONS, SPRAY DRIFT PROCEDURES, and SPRAY DRIFT PROCEDURES IN 

RIO GRANDE VALLEY sections on page 3 so that they are within the 

DIRECTION FOR USE section. 

5. Change the heading from "GENERAL INFORMATION" to "PRODUCT 

INFORMATION 

" 

6. Change the heading from "USE PRECAUTION" to "USE RESTRICTION". 

7. Change the heading to "RESTRICTIONS TO LOWER SPRAY DRIFT 

POTENTIAL 

8. 

ONTO NON-TARGET CROPS" 

restrictions will help 

Change the sentence to "The 

reduce drift potential:" 

following 

Change the heading to "RESTRICTIONS TO LOWER SPRAY DRIFT 

POTENTIAL IN 

9. 

10. 

THE RIO GRANDE VALLEY OF TEXAS". change the sentence to "The 

following restrictions will help reduce drift potential:" Change the 

last bullet to "CITRUS AREAS: Do not apply this product by ground 

within 0.5 mile or by air within 5 miles downwind of the point of 

application when citrus is in flush." 

Add the following restriction to both spray drift sections: 

"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." 

Change the phrase under APPLICATION to "specified amount". 

11. Under DOSAGE, change the sentence to "The 0.05 lb. rate is most 

effective when used in a tank mix with other cotton defoliant 

products. " 

Please submit a revised clean copy of the label via email to my 

attention and feel free to contact me if you have any questions. 

Thanks, 

Mindy Ondish 

Biologist / Risk Manager 

Herbicide Branch (PM Team 25) 

Registration Division (7505P) 

Office of Pesticide Programs 

U.S. Environmental Protection Agency 

Phone: 703-605-0723 
16

( 

Date: May 18, 20 I 0 

Reg. No.: 66330-334 

Product Name: Thidiazuron 4 SC 

PM NamelNumber: Kathryn Montague, Risk Management Team 23 

Primary Reviewer: Judy Loranger ~ .-<.-0 ~04-;fLJ (0)9// 0 

Secondary Reviewer: Mark Perry ~ 

New label or date ofRD amended label: New, Received on 2125/09 

Formulation Type: Liquid 

Active Ingredient Assessed: Thidiazuronl120301 

Other ai's in product 

Name!PC code: Reregistration Status or Registration Date: 

N/A N/A 

Note to PM: 

I) The Risk Management and Implementation Branch V (RMIB V) 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) For clarification, RMIB V suggests that the spray drift text required in the RED and 

which appears on the label be revised to read: 

''Thidiazuron products can not be applied by air within ~ miles of lettuce or within 5 

miles upwind of citru_s in flush (burst of new growth, as in springtime) in the Rio 

Grande valley of Texas. Ground applications are restricted to no less than 100 feet 

away from lettuce and no less than ~ mile upwind from citrus." 

Assessment can be found N:lprbllabe11066330/334 

1) Per the product chemistry review, physical or chemical hazards text must be added to 

the label. 

2) Per the RED label table and Appendix A, the rate restriction text should be revised to 

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

"Rate restrictions under normal conditions: 

Maximum application rate is 0.125 lbs ai per acre. 

I 
17

( 

Maximum application rate is 0.3 Ibs ai per acre per year. 

Maximum of 2 applications, but not to exceed 0.3 Ibs ai per acre per year. 

Rate restrictions under variable conditions: 

Maximum application rate is O.21bs ai per acre. 

Maximum application rate is 0.3 Ibs ai per acre per year. 

Maximum of 2 applications, but not to exceed 0.3 Ibs ai per acre per year." 

3) The text" The 0.5 lb rate" on the bottom of Page 6 of the label must be revised per the 

RED to read "The 0.05 Ib rate is most effective when used in a tank mix with other 

cotton defoliant products is most effective when used in a tank mix with other cotton 

defoliant products." 

2 
18

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

WASHINGTON, D.C. 20460 

April I, 2009 

MEMORANDUM: 

Subject: 

From: 

To: 

Applicant: 

EPA Reg. No.: 66330-334/ Thidiazuron 4 SC 

DP Barcode: 363248 

Case No.: 4092 

John L. Dupuy Ph.D, Pathologist a~· ~I 3'~'-P§?17- Product Reregistration Branch ! V 

Special Review and Reregistr . on Division (7508P) 

Barbara Briscoe, CRM 

Product Reregistration Branch 

Special Review and Reregistration Division (7508P) 

Arysta LifeScience North America, LLC 

15401 Weston Parkway, Suite 150 

Cary, NC 27513 

FORMULATION FROM EPA Reg. No. 66330-334 LABEL: 

Active Ingredient(s): 

OFFICE OF 

PREVENTION, PESTICIDES 

AND TOXIC SUBSTANCES 

%bywt. 

Thidiazuron .............. _ ..................................................................... 42.4% 

Other Ingredient(s): ................................................................................................. 57.6% 

Total 100.0% 
19

( 

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. 66330-334. The 

MRID's are as follows: 476859-01 (81-1),476859-02 (81-2), 476859-03 (81-3),476859-04 (81-

4),476859-05 (81-5), 476859-06 (81-6). The studies were conducted by Stilhneadow, Inc. The 

test material used in each of the studies was the subject product. 

RECOMMENDATIONS: 

• The acute toxicity studies submitted are acceptable to support the reregistration of EPA 

Reg. No. 66330-334. 

The acute toxicity profile for EPA Reg. No. 66330-334 is currently: 

Acute Oral N Acceptable 

Acute Dennal N Acceptable 

Acute Inhalation N Acceptable 

Primary Eye N Acceptable 

Primary Dermal N Acceptable 

Skin Sensitization non sensitizer Acceptable 

NOTE: The acute toxicity requirements have been satisfied for the subject product. 
20

( 

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

Product Manager: Joanne Miller, 23 

MRlD No.: 476859-01 

Testing Facility: Stillmeadow Inc. 

Author: J. Knhu 

Quality Assurance (40 CFR §160.12): Included 

Test Material: Thidiazuron 4 SC, beige liquid 

Species: Sprague-Dawley albino rat 

Age: young adult 

Weight: females ~ 164- 198 g 

Source: Texas Animal Specialties 

Conclusion: (Up and Down Method) 

1. LDso (mglkg): > 5000 mg/kg 

2. Toxicity Category: IV 

Procedure (Deviations from §81-1): none 

Results: 

Main Test 

Reviewer: John L. Dupuy Ph.D 

Study Completion Date: 1127/09 

Report No.: 12580·08 

Classification: Acceptable 

Test Sequence Auimalld Dose Level Short tenn Longtenn 

(mglkg) outcome outcome 

I 271 5.000 D D 

2 272 175 S S 

3 273 550 S S 

4 274 1.750 S S 

5 275 5.000 S S 

6 277 5,000 S S 

7 278 5,000 S S 

Observations' . Dose Time of Death Clinical Observations 

mglkg 

5,000 117 on day 2 Piloerection, activity decrease, lateral recumbency 

Gross Necropsy: Decedent: 117 stomach filled with white fluid. Survivors: 617 no gross 

abnonnalities noted. 
21

( 

DATA REVIEW FOR ACUTE DERMAL TOXICITY (§81-2, 870.1100) 

Product Manager: Joanne Miller, 23 

MRID No.: 476859-02 

Reviewer: John L. Dupuy Ph.D 

Study Completion Date: 2/6/09 

Report No.: 12581-08 

Testing Facility: Stillmeadow Inc. 

Author: J. Kuhn 

Quality Assurance (40 CFR §160.12): Included 

Test Material: Thidiazuron 4 SC, beige liquid 

Species: Sprague-Dawley albino rat 

Weight: males ~ 296 - 326 g; females ~ 175 - 204 g 

Age: young adult 

Source: Texas Animal Specialties 

Summary: 

1. 1.050 (mglkg): >5050 mg/kg 

2. Toxicity Category: IV Classification: Acceptable 

Procedure (Deviations From §81-2): none 

ResuJts: Reported Mortality 

Dosage (mg/kg) (number deaths/number tested) 

Males Females Combined 

5050 015 015 0110 

Observations: Twenty four hours prior to application of the test material, the dorsal surface of 

the trunk was clipped free of hair not less than 10% of the total body surface area. The test 

material was applied neat to an intact test site, covered by a 2 x 4 inch surgical gauze patch and 

secured with non-irritating adhesive tape. The trunks were wrapped with vet wrap which was 

secured with non-irritating adhesive tape. After 24 hours, the wraps and pads were removed and 

the test sites were gently cleansed. One female lost weight during the first week and one male and 

female lost weight during the second week. 

Gross Necropsy Findings: No observable abnonnalities were noted. 
22

( ( 

DATA REVIEW FOR ACUTE INHALATION TOXICITY TESTING (§81-3, 870.1300) 

Product Manager: Joanne Miller, 23 

MRID No.: 476859-03 

Reviewer: John L. Dupuy Ph.D 

Study Completion Date: 2/9109 

Report No.: 12582-08 

Testing Facility: Stillmeadow Inc. 

Author: C. Younger 

Quality Assurance (40 CFR §160.12): Included 

Test Material: Thidiazuron 4 SC, beige liquid 

Species: Sprague-Dawley albino rat 

Weight: males ~ 282 - 312 g, females ~ 184 - 214 g 

Age: young adult 

Source: Texas Animal Specialties 

Summary: 

1. LCso (mgIL): > 2.33 mglL 

2. MMAD: 2.4~m GSD: 6.3 

3. Tox. Category: IV Classification: Acceptable 

Procedure (Deviation From §81-3): None 

Results: Reported Mortality 

Exposure (number deaths/number tested) 

Concentration Males Females 

2.33 mg/l 015 015 

Chamber Atmosphere 

Dose Level mgII MMAD GSD 

2.33 2.4~m 6.3 

1.4~m 6.4 

combined 

0110 
23

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Chamber Dose Level rng/l 

Environment 2.33 

Chamber Volume SOOL 

Airflow 181 Lorn 

Temperature eCl 19.8-21.9 

Relative Humiditv % 32.1-38.1 

Clinical Observations: 10110 exhibited activity decrease and piloerection from 4.5 hours through 

day 4. All gained weight during the study. 

Gross Necropsy Findings: No observable abnonnalities noted. 
24

( 

DATA REVIEW FOR PRIMARY EYE IRRITATION TESTING (§81-4, 870.2400) 

Prod~ct Manager: Joanne Miller. 23 

MRlD No.: 476859-04 

Testing Facility: Stillmeadow, Inc. 

Author: J. Kuhn 

Quality Assurance (40 CFR §160.12): Included 

Test Material: Thidiazuron 4 SC. beige liquid 

Dosage: 0.1 ml 

Species: New Zealand White albino rabbit 

Sex: 1 male and 2 females 

Reviewer: John L. Dupuy Ph.D 

Study Completion Date: 1126/09 

Report No.: 12583-08 

Weight: male ~ 2.125 kg, females ~ 2.250 - 2.350 kg 

Age: young adult 

Source: Nichols Rabbitry Inc. 

Summary: 

Toxicity Category N Classification: Acceptable 

Procedure (Deviations From §81-4): none 

Results 

(number "J: ositive"/number tested) 

Observations Hours Days 

I 24 48 72 

Corneal Opacity 0/3 0/3 0/3 0/3 

Iris 0/3 0/3 0/3 0/3 

Conjunctivae 

Redness 0/3 0/3 0/3 0/3 

Chemosis 0/3 0/3 0/3 0/3 

Discharge 0/3 0/3 0/3 0/3 

No ocular irritation was noted during the study. 
25

( 

DATA REVIEW FOR SKIN IRRITATION TESTING (§81-5, 870.2500) 

Product Manager: Joanne Miller, 23 

MRID No.: 476859-05 

Testing Facility: Stillmeadow Inc. 

Author: J. Kuhn 

Quality Assurance (40 CFR §160.12): Included 

Test Material: Thidiazuron 4 SC, beige liquid 

Dosage: 0.5 ml 

Species: New Zealand White albino rabbit 

Age: young adult 

Sex: 2 males; I female 

Reviewer: John L. Dupuy Ph.D 

Study Completion Date: 1130109 

Report No.: 12584-08 

Weight: males ~ 2.300 kg, female ~ 2.350 kg 

Source: Nichols Rabbitry Inc. 

Summary: 

1. Toxicity Category: IV 

2. Classification: Acceptable PDII~ 0.0 

Procedure (Deviations From §81~5): none 

Results: Twenty four hours prior to application of the test material, the dorsal area of the trunk: 

was clipped free of hair to expose an area of at least 8 x 8 em. The test material was applied neat 

to an intact test site and covered with a 4 ply, 2.5 x 2.5 em surgical gauze patch. Each patch was 

secured with non-irritating adhesive tape. The trunks were wrapped with a orthopedic stockinette 

which was secured with strips of tape. After 4 hours, the wraps and pads were removed and the 

test sites were gently cleansed with tap water. 

No dennal irritation was noted. 
26

( 

DATA REVIEW FOR DERMAL SENSITIZATION TESTING (§81-6. 870.2600) 

Product Manager: Joanne Miller, 23 

MRID No.: 476859-06 

Testing Facility: Stillmeadow Inc. 

Author: J. Kuhn 

Quality Assurance (40 CFR §160.12): Included 

Test Material: Thidiazuron 4 SC, beige liquid 

Reviewer: John L. Dupuy Ph.D 

Study Completion Date: 1130/09 

Report No.: 12585-08 

Positive Control Material: HCA, historical control #11950~08, 7/5/08 

Species: Hartley albino guinea pig 

Weight: males ~ 372- 438 g. females ~ 325-406 g 

Age: young adult 

Source: Charles River Laboratories 

Method: Buehler 

Summary: 

1. This Product is a non-sensitizer 

2. Classification: Acceptable 

Procedure (Deviation From §81~6): none 

Procedure: 

A group of animals were used to detennine the highest non-irritating concentration (HNIC) of the 

test substance prior to the challenge dose. The HNIC for the test substance was detennined to be 

100% test material. 

The test animals were induced with 0.4 mL of 100% test material applied beneath a 4 ply, 2.5 x 

2.5 em surgical gauze patch over wrapped with clear polyethylene film and secured in place with 

tape once weekly for 3 weeks. Twenty four and 48 hours after each induction dose the animals 

were scored for irritation. Two weeks after the last induction dose, 0.4 mL of 100% test material 

was used to challenge the test animals. Twenty four and 48 hours after the challenge the animals 

were evaluated for sensitization. 

A group often animals were used as naive controls. These animals received only the challenge 

doses of the test material. 
27

( ( 

Results: 

During the induction phase of the study, no dermal reactions were noted for the test material 

induced animals. 

Twenty four hours after the challenge, no dennal reactions were noted for either the test group or 

the naive control group. 
28

LABELING: 

ID #: 066330-00334 THIDIAZURON 4 SC 

SIGNAL WORD·: CAUTION 

HAZARDS TO HUMANS AND DOMESTIC ANIMALS: 

Wear long sleeved shirt, long pants, shoes, and socks. 

FIRST AID: 

IF SWALLOWED: Call a poison control center or doctor immediately for treatment 

advice. Have person sip a glass of water if able to swallow. Do not induce vomiting 

unless told to by a poison control center or doctor. Do not give anything by mouth to an 

unconscious person. 

IF ON SKIN OR CLOTHING: Take off contaminated clothing. Rinse skin immediately 

with plenty of water for 15-20 minutes. Call a poison control center or doctor for 

treatment advice. 

IF INHALED: Move person to fresh air. If person is not breathing, call 911 or ambulance, 

then give artificial respiration, preferably mouth-to-mouth, ifpossible. Call a poison 

control center or doctor for further treatment advice. 

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

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

a poison control center or doctor for treatment advice. 

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

doctor or going for treatment. You may also contact 1-800-xxx-xxxx for emergency 

medical treatment infonnation. 

*Note to Label Review Team: No First Aid statements or Signal Word are required due to the 

toxicity categories. If the registrant wishes to include First Aid statements or Signal Word then 

they must be the same as listed above. 

USER SAFETY RECOMMENDATIONS: 

User should wash hands before eating, drinking, chewing gum, using tobacco, or using the 

toilet. 

User should remove clothingIPPE immediately if pesticide gets inside. Then wash 
29

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. 
30

1 

DATE OUT: 06/MAY/2010 

SUBJECT: PRODUCT CHEMISTRY REVIEW OF: TGAI [[; MUP []; EUP [X] 

BARCODE NO.: D376597 REG.IFILE SYMBOL NO.: 66330-334 

PRODUCT NAME: ....'cTC-hi!!!d'-'ia"'z';"ur":o~n;;4c;S"C~=-:;---:-_-C--;-;-:; ____ -:-::==:-===--:c:-: 

COMPANY NAME: Arysta LifeScience North America, LLC ACTION CODE: 676 

CONTRACTOR:_C"",SC~ ___________ PROJECT CODE: PRD-56 OPII 

FROM: 

TO: 

Maria Rivera Piansay, Chemist r J~ ~~1 Product Chemistry Team '. \j / 

Risk Management and Implementation Branch V ! 

Pesticide Rewevaluation Division (7508P) 

Barbara Briscoe, CRM 

Risk Management and Implementation Branch V 

Pesticide Re-evaluation Division (7508P) 

INTRODUCTION: 

With this resubmission, Arysta LifeScience North America, LLC provided a revised Confidential 

Statement of Formula (CSF) for the basic formulation, dated 04/05/2010. The registrant is req1iesting 

reregistration of their product, Thidiazuron 4 SC, EPA Reg. No. 66330-334. 

FINDINGS: 

1. EPA Reg. No. 66330-334 is an end-use cotton defoliant, containing the active ingredient, 

Thidiazuron, with a label claim nominal concentration of 42.4%. The product is a harvest aid 

compound, used for leaf removal prior to cotton harvest. The prochlCt is for agricultural use only. 

The product is produced by a non-integrated system. 

2. The CSF has been revised as requested in our review of 03/05/10. The revision involved changing 

the nominal concentration of the active ingredient from 42.7% to 42.4%, to match the label and 

the concentration of record with the Agency. TIle CSF and the label are now in agreement and in 

compliance with PR Notice 91-2. 

3a. The Active fngredient Statement on the draft label is now acceptable as per 40 CFR §156.10(g) 

and PR Notices 91 -2 and 97-6. 

3b. Data are present to trigger the need for a Physical or Chemical Hazards Statement: Add the 

heading "Physical or Chemical Hazards" to the product label immediately below the 

Environmental Hazards Statement; and under the new Physical or Chemical Hazards Statement, 

place a statement regarding the incompatibility of the product with other chemicals (e.g., oxidizing 

agents) as evidenced by the data provided in response to Guideline 830.6314 (OxidatiOlll 

RechlCtion; Chemical Incompatibility). 

3c. The Storage and Disposal Statements are acceptable in accordance with 40 CFR § 156.1 O(i)(2)(ix) 

and PR Notice 83-3 . 

NOTE TO CRM: The labeling issues should be addressed during label review. 
31

I 

2 

CONCLUSIONS: 

The revised CSF is acceptable to support reregistration of the subject product. This CSF Sh01l1d supersede 

previous CSFs for this product. 

The registrant has now satisfied the product chemistry requirements for the reregistration of EPA Reg. No. 

66330-334. 
32

( 

1 

DATE OUT: 05/MARl2010 

SUBJECT: PRODUCT CHEMISTRY REVIEW OF: TGAI [[: MUP [I: EUP [XI 

BARCODE NO.: D372032 REG.IFILE SYMBOL NO.: 66330-334 

PRODUCT NAME: Thidiazuron 4 SC MRID NOS.: 462362-01.462448-01. and 468175-01 

COMPANY NAME: Arysta LifeScience North America. LLC ACTION CODE: 676 

CONTRACTOR: CSC PROJECT CODE: PRD-560PlI 

FROM: 

TO: 

Maria Rivera Piansay, Chemist! k-, <. i' ~(7' \\ ~~ 

Product Chemistry Team \' ! \ 

Risk Management and Implementation Branch V v 

Product Re~evaluation Division (7508P) 

Barbara Briscoe, CRM 

Risk Management and Implementation Branch V 

Product Re-evaluation Division (7508P) 

INTRODUCTION: 

A Reregistration Eligibility Decision (RED), Case number 4092, was issued in September 2005 for the 

Technical Grade Active Ingredient (TGAI) Thidiazuron. According to the RED, the generic data base 

supporting the reregistration ofThidiazuron for eligible uses has been reviewed and found to be 

Sllbstantially complete. 

In the 8~month response to the Thidiazuron RED, Arysta LifeScience North America, LLC provided a 

Confidential Statement of Formula (CSF) for the basic formulation, dated 12/20/2008; and a draft label 

(pin-punched 02125109). The registrant cited product chemistry data, including MRID Nos. 462362~01, 

462448~01, and 468175~0 1. The registrant is requesting reregistration of their prodlict, Thidiazuron 4 SC, 

EPA Reg. No. 66330-334. 

FINDINGS: 

1. EPA Reg. No. 66330~334 is an ep.d~use cotton defoliant, containing the active ingrediel1t, 

Thidiazuron, with a label claim nominal concentration of 42.4%. [We note that the label claim 

nominal concentration does not match that in the CSF, which is 42.7%. The concentration of 

record with the Agency is 42.4%]. The product is a harvest aid compound, used for leaf removal 

prior to cotton harvest. The product is for agricultural use only. The product is prodliced by a 

non~integrated system. 

2. The CSF for the basic formulation is not acceptable because the label claim nominal 

concentration, 42.4%, does not match the concentration in the CSF, 42,7%, The label or the CSF 

must be changed because these hvo must agree, in accordance with PR Notice 91-2. 

THIS REVIEW CONTAINS FIFRA CBI 
33

( ( 

2 

3. The data reported in MRID Nos. 462362-01, 462448-01, and 468175-01 satisfY the product 

chemistry requirements as specified in 40 CFR §158.155, 158.160, 158.165, 158.167, 158.175, 

and 158.180 (the new 40 CFR section numbers are 158.320, 158.325, 158.335, 158.340, 158.350, 

and 158.355, respectively) which pertain to Product Identity and Composition, Description of 

Materials Used to Produce the Product, Description ofFonnulation Process, Discussion of 

Formation of Impurities, Certified Limits, and Enforcement Analytical Method. 

The data also satisfy the product chemistry requirements as specified in 40 CFR § 158.190 (the 

new 40 CFR number is 158.310) which pertain to the Physical and Chemical properties of the 

product. 

4. The Enforcement Analytical Method for the determination ofThidiazuron content in the product is 

presented in MRID No. 462448-01. The method is adequate and satisfies the requirements under 

Guideline 830.1800. 

5a. The Active Ingredient Statement on the draft label is not acceptable as per 40 CFR §156.1 O(g) and 

PR Notices 91-2 and 97-6. The concentrations must be harmonized as per PR Notice 91-2. See 

Finding 2. 

5b. Data are present to trigger the need for a Physical or Chemical Hazards Statement: Add the 

heading "Physical or Chemical Hazards" to the product label immediately below the 

Environmental Hazards Statement; and under the new PhYSical or Chemical Hazards Statement, 

place a statement regarding the incompatibility of the product with other chemicals (e.g., oxidizing 

agents) as evidenced by the data provided in response to G1lideline 830.6314 (Oxidation! 

Reduction; Chemical Incompatibility). 

5c. The Storage and Disposal Statements are acceptable in accordance with 40 CFR §156.1 0(i)(2)(ix) 

and PR Notice 83-3 . 

NOTE TO CRM: The labeling issues should be addressed during label review. 

CONCLUSIONS: 

After submission of a revised CSF and!or a revised label, as noted in Findings 2 and Sa, respectively, the 

registrant will satisty the product chemistry requirements for the reregistration of EPA Reg. No. 66330-

334. 
34

( ( 

3 

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) 40 CFR§ MRIDNumber 

I Title 830 

830.1550 Product Identity and 158.320 462448-01 

Composition 

830.1600 Description of 158.325 462448-01 

Materials Used to Produce the 

Product 

830.1620 Description of 158.330 [Not required for products 

Production Process produced by a nonintezrated system! 

830,1650 Description of 158.335 462448-01 

Formulation Process 

830.1670 Discussion of 158.340 462448-01 

Formation ofImpurities 

830.1700 Preliminary Analysis 158.345 [Not required/or products 

produced by a noninteI!rated system 1 

830.1750 Certified Limits 158.350 462448-01 and CSF 

830.1800 Enforcement Analytical 158.355 462448-01 

Method 

Subgroup B: Guideline Series 830.6302 - 7950 (40 CFR §158.310) 

Pbysical and Chemical Properties 

Guideline Reference No. Value or Qualitative MRID Number 

(GRN) / Titl. 830 Deserintion 

.6302 Color [Not required for end-use 

products.] 

.6303 Physical State LiQuid at 25°C 462362-01 

Data Fulfilled 

Y 

Y 

N/A 

Y 

Y 

N/A 

Y 

Y 

Data 

Fulfilled 

N/A 

Y 
35

( 

4 

Guideline Reference No. Value or Qualitative MRID Number Data 

(GRN) i Title 830 Dcscrintion Fulfilled 

.6304 Odor [Not required for end-lise NiA 

ol'Oduc/s. 7 

.6314 Oxidation! Reduction: Compatible with distilled 462362-01 y 

Chemical Incompatibility water, iron powder, and 

monoammonium 

phosphate. A reaction was 

observed when mixed with 

potassium pennanganate 

(Le., gas evolved; heat 

generated) . 

. 6315 Flammability/Flame >93°C 462362-01 Y 

Extension 

.6316 Explodability Not applicable. The 462362-01 y 

product does not contain 

any known explosive 

comoonents . 

. 6317 Storage Stability Time Point Active 468175-01 y 

Conc. 

Initial 42.8% 

3 months 43.3% 

6 months 43.0% 

9 months 43.2% 

12 months 42.9% 

Results demonstrate 

stability for 12 months 

under warehouse 

conditions. No significant 

change in the active 

ingredient concentration 

(or dle product's 

appearance) was observed 

over the l2-month 

interval. The product was 

tested in white HDPE 

bottles. 
36

( ( 

5 

Guideline Reference No. Value or Qualitative MRID Number Data 

(GRN) I Title 830 Description Fulfilled 

.6319 Miscibility Not applicable. The 462362-01 Y 

product shall not be 

diluted with non-polar 

solvents. 

.6320 Corrosion Results demonstrate that 468175-01 Y 

Characteristics the product is not 

corrosive to its packaging 

after storage for 12 months 

under warehouse 

conditions. No apparent 

corrosion of the packaging 

material due to the product 

was observed. TIle 

product was tested in 

white HDPE bottles. 

,6321 Dielectric Breakdown Not applicable. The 462362-01 Y 

Voltage product shall not be used 

on or in the vicinity of 

electrical equipment and 

electrical conduits . 

. 7000 pH 5.78 at 25°C 462362-01 Y 

.7100 Viscosity 1236 mPa s at 25°C 462362-01 Y 

.7300 DensityfRelative 1.1752 glmL at 25°C 462362-01 Y 

Density 

Explanations: Y = Requirement fulfilled; N = Requirement not fulfilled; N/A = Not applicable; 

G = Data gap; U = Upgradeable; I = Incomplete or in progress; W = Waived; NR = Not required 

Enforcement Analytical Method, Guideline 830.1800 (MRID No. 462448-01) 

An HPLC method is used to determine Thidiazuron content. in the product ("Determination of 

Thidiazuron"). The method provides procedures for preparing standards and samples, a description of 

the instrument system, and equations for calculations. This method is found to be adequate and would 

satisfY Guideline 830.1800. 

The HPLC system consists of the following: 

Instrument: Liquid chromatograph equipped with a UV detector and 

Detector: 

Column: 

Mobile Phase: 

integrator 

283 nm, fixed wavelength 

Luna C-18, 5 11m or equivalent, 15 cm x 4.6 mm Ld. 

60/40: AcetonitrilelHPLC water 
37

Diluent: 

Flow Rate: 

Run Time: 

Column Temperature: 

6 

60/40: Acetonitrile/HPLC water 

1.0 mLlminute 

15 minutes 

30°C 

Confidential Appendix A 

830.1550 Product Identity and Composition 

EPA Reg. No. 66330-334 is an end-use product produced by a non-integrated system. The product 

contains the active ingredient, Thidiazuron, with a label claim nominal concentration of 42.4%. [Note that 

the label claim nominal concentration of the active ingredient does not match the concentration in the 

CSF}. The registered product, Thidiazuron Technical (EPA Reg. No. 66330-324; 98.3% active), is the 

source of the active ingredient. Nominal concentrations and upper!lower certified limits are identified on 

the CSF. 

830.1600 Description of Materials Used to Produce the Product 

The starting materials used in the formulation of EPA Reg. No. 66330~334 are identified in MRID No. 

462448~01. Technical specifications for the formulation compori.ents are provided in MRID No. 462448~ 

01. 

830.1650 Description of Fonnulation Process 

*Manufacturing process information may be entitled to confidential treatment*
38

THIS REVIEW CONTAINS FIFRA CBI 

*Manufacturing process information may be entitled to confidential treatment*
39

( 

PRODUCT REREGISTRATION 

SUPPORTING DOCUMENTATION 

FOR 

Case Name: Th l d I C{zuro n 

This supporting documentation (in chronological order) 

includes: 

o Old labels (identified as "Superceded by label dated xx/xx/xx') 

@l Unacceptable CSFs (marked "Not Acceptable" and dated) 

o Product chemistry reviews 

o Acute Toxicity reviews 

o Efficacy reviews (if necessary) 

® 90-day responses to PDCI (Form A and Form B) 

® Administrative forms (Application for Reregistration, Certification 

to Data Citation, Data Matrix) 

~ Correspondence 
40

rl 

o:[)'" 

....D '>,,;0 D:1 \\? 11 \I 

ru 

.-=t: i-='----,---i 

CcrtiITod 

.-=t: o R&!um Fcc H<;ro o (End<.",:JlTh'nfRC<ju!!w) B ".).' o . r..r ... sC"'oe 5/11/09 (EnOOn:nrw.:n! RC<.lwad) o 

To!aIPosbga&FflnS $ 

rl 

0:0 ,';em 0 Mr. Bill Washburn/Regulatory Mgr. 

o ,),I:ysJ:.a .. W-tftS.ci!l)l.c.o .............................................. . I;;/mti. Ap!. NO., 

a orFOIkNt.'I1. 15401 Weston Parkway. Suite 150 ["- .. _-_ .... -.. ,._-....... -.... -............. -.... --_ ..... - .......... -_ ... -............ -. Cdy, stJln, ZIPt4 

, 

-
41

, 

! 

, \ \\ 1 

;i ! "U' '\ ' , , 

( 

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

CERTIFIED MAIL 

Mr. Bill Washburn 

Regulatory Manager 

Arysta LifeScience 

MAY 111009 

OFfiCE OF 

PREVENTION, PESTICIDES ANQ 

TOXIC SUBSTANCES 

15401 Weston Parkway, Suite 150 

Cary, NC 27513 

SU8JECT: Thidiazuron Reregistration Eligibility Decision (RED), Review of Acute 

Toxicity Data, EPA Registration Number 66330-334 

Dear Mr. Washburn: 

Your submission of acute toxicity data required in response to the thidiazuron 

Product Specific Data Call-In Notice has been reviewed, The Agency has determined that 

the acute toxicity studies are acceptable. 

The acute toxicity profile for EPA Registration No. 66330-334 is currently: 

Guideline Study MRlDNumber Toxicity Category Classification 

81-1 AtUte Oral 47685901 IV Acceptable/Fulfilled 

81-2 Acute Dermal 47685902 IV Acceptable/Fulfilled 

81-3 Acute Inhalation 47685903 IV Accepta b Ie/Fulfilled 

81-4 Primary Eye 47685904 IV Acceptable/Fulfilled 

81-5 Primary Dermal 47685905 IV Acce ptab Ie/Fulfilled 

81-6 Skin Sensitization 47685906 non sensitizer Acceptable/Fulfilled 

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, 

POv1ftt~£ /lUL 

Patricia L. Moe, Chief 

Product Reregistration Branch 

Special Review and Reregistration Division 

Enclosure 
42

( ( 

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

CERTIFIED MAIL 

Mr. Bill Washburn 

Regulatory Manager 

Arysta LifeScience 

15401 Weston Parkway, Suite 150 

Cary, NC 27513 

MAY 11 Z009 

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

Toxicity Data, EPA Registration Number 66330~334 

Dear Mr. Washburn: 

Your submission of acute toxicity data required in response to the thidiazuron 

Product Specific Data Call~In Notice has been reviewed. The Agency has determined that 

the acute toxicity studies are acceptable. 

The acute toxicity profile for EPA Registration No. 66330-334 is currently: 

Guideline Study MRID Number Toxicity Category Classification 

81-1 Acute Oral 47685901 IV A ccepta b Ie IFuI fi II ed 

81-2 Acute Dermal 47685902 IV AcceptabIejFulfiIied 

81-3 Acute Inhalation 47685903 IV A cce ptab lei FuIfi lIed 

81-4 Primary Eye 47685904 IV A ccepta ble jFu Ifil I ed 

81-5 Primary Dermal 47685905 IV AcceptablejFulfiIied 

81-6 Skin Sensitization 47685906 non sensitizer Accep table jFulfilie d 

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 

Enclosure 

CONCURENCES 

7508P 7J-'" " \Y 

Briscoe 

4-17-09 ;;'7/." - EPA FORM 13 0-1A (1/90) Printed on Recycled Paper OFFICIAL FILE COPY 
43

e Arysta LifeScience 

VIA FEDEX DELIVERY (Tracking No. 7963 6824 9095) 

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 4 SC 

EPA Reg. No. 66330·334 

8·Month Response to Data Call·ln dated 5/08/08 

478869.00 

February 24, 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 a-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 Intemal 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. 

ArysIa LifeSclence North America. LLC 

15401 Weslon Parllway, SUUe 150, Cary, NC 27513 Phone 919·678·4900 Fax 919·678·2194 

www.arys1alifescience.com 
44

Page2of2 

4. EPA Form 8570-34 (Ceriification 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. 

5. Draft Label for Thidiazuron 4 se 

Five copies of a draft label for Thidiazuron 4 SC, one redlined copy (Filename: 

Thidiazuron 4 SC(430-08170S)(66330-334 RED + PR2007-4 Redline.doc) and four 

clean copies (Filename: Thidiazuron 4 SC(430-08170S)(66330-334 RED + PR2007-4 

Clean.doc) are enclosed. 

6. 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. 

7. 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, 

8~~~ Bill Washburn 

Regulatory Manager 

Phone: (901) 432-5118 

E-Mail: bill.washburn@arystalifescience.com 
45

Arysta LifeScience North America, LLC 

15401 Weston Parkway, Suite 150 

Cary, North Carolina 27513 

BIBLIOGRAPHY OF SUBMITIED STUDIES 

Product Name: Thidiazuron 4SC EPA Registration Number: 66330-334 

Purpose of Submission: 

Date of Submission: 

8 Month Response to Data Call-In 

February 24, 2009 

1016 Acute Oral Toxicity Study (UDP) in Rats 12580-08 

2016 Acute Dermal Toxicity Study in Rats 12581-08 

3016 Acute Inhalation Toxicity Study in Rats 12582-08 

4016 Acute Eye Irritation Study in Rabbits 12583-08 

5016 Acute Dermal Irritation Study in Rabbits 12584-08 

6016 I Skin Sensitization Study in Guinea Pigs 12585-08 

870.1100 870.1200 870.1300 870.2400 870.2500 870.2600 

Acute Tox Acute Tox Acute Tox 

Acute Tox 

Acute Tox Acute Tox 
46

- UNITED STATES ENVIRONMENTAL PROTECTION AGENCY Form 

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 0.25 hours per response for registration acliviU

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

of information, including suggestions for reducing the burden to: Director, OPPE Information Management Division (2137), U.S. Environmental Protection Agency, 401 

Do not send the form to this address. 

DATA MATRIX 

Date February 19, 2009 EPA Reg. No.fFile Symbol 66330-334 

Applicanl'sfRegistrant's Name & Address: Product 

Arysta LifeScience North America, LLC, 15401 Weston Parkway, Suite 100, Cary, NC 275137 THIDIAZURON 4SC 

Ingredient(s): Thidiazuron 

Guideline Reference Number Guideline Study Name MRID Number Submiller Status 

ProduC'l Chemistry 

Series 830A Product Identity and Composition, et.al. 46244801 Arysta UfeScience North America Own Series 8308 Physical and Chemical Characteristics 46236201 Arysta UfeScience North America Own 

830.6317 1830.6320 Storage Stability 1 Corrosion Characteristics 46817501 Arysta UfeScience North America Own 

Acute Toxicology 

870.1100 Acute Oral Toxici Arysta UfeScience North America Own 870.1200 Acute Dermal Toxicity Arysta UfeScience North America Own 870.1300 Acute Inhalation Toxicity Arysta UfeScience North America Own 870.2400 Prima E e Irritation A sta UfeScience North America Own 870.2500 Prima Dermallrritalion A sta UfeScience North America Own 870.2600 Skin Sensitization Arysta UfeScience North America Own 

Signature Name and Title: 

Bill Washburn, Regulatory Manager 

EPA Form 8570-35 (9-97) Electronic and Paper versions available. Submt only Paper version. 
47

o 

-

Dale 2009 

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

401 M Street, S.W, 

WASHINGTON, D,C. 20460 

average v. 

for reading the instructions and completing the necessary forms. 

burden to: Director, OPPE Information Management Division (2137). 

DATA MATRIX 

EPA 

Product 

LifeScience North America, LLC, 15401 Weston Parkway, Suite 100, Cary, NC 275137 

Signature Name and Title: 

66330-334 

Bill Washburn, Regulatory Manager 

EPA' FOhn 6570.35\9.97) EIe<:lronic and Paper versions available. Submit only Paper version. 

Form 

401 
48

( , Fonn Approved OMS No. 2070-006 , 

'"' UNITED STATES ENVIRONMENTAL PROTEC1,-,N AGENCY 

0 401 M Street, S.W. 

WASHINGTON, D.C. 20460 

Paperwork Reduction Act Notice: The public reporting burden for this collection of infonnation is estimated to average 1.25 hours per response for 

registration activities and 0.25 hours per response for reregistration and special review activities, including time for reading the instructions and completing 

the necessary follTls. Send comments regarding the burden estimate or any other aspect of this collection of information, including suggestions for reducing 

the burden to: Director, OPPE infonnation Management Division (2137). U.S. Environmental Protection Agency, 401 M Street, S.W., Washington, DC 20460. 

Do not send the fonn to this address. 

Certification with Respect to Citation of Data 

Applicant's!Registrant's Name, Address and Telephone Number EPA Registration Number! File Symbol 

Arysta LifeScience N. A. LLC,15401 Weston Parkway, Suite 150, Cary, NC 27513 66330-334 

Active Ingredient(s) and/or representative test compound(s): Date 

Thidiazuron, Diuron February 19, 2009 

General use pattem(s) (list all those claimed for this product using 40 CFR Part 158) Product Name 

Terrestrial, Non-Food Use (Cotton) THIDIAZURON 4 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 fonn. You must submit the Formulator's Exemotion Statement (EPA Form 8570-27l. 

121 I am responding to a Data Call-In Notice, and have included with this form a list of companies sent offers of compensation (the Data 

Matrix form should be used for this purpose). 

SECTION I: METHOD OF DATASUPPORT (Check one method only) 

D I am using the cite-all method of support, and have included with 121 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 fonn a 

Data Matrix form should be used for this purpose). comple~i.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 or when using the cite-all option under the selective method to satisfy one or more data requirements] 

D I hereby offer and agree to pay compensation, to other persons, with regard to the approval of this application, to the extent required by 

RFRA. 

SECTION JJI: 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) concern the properties or 

effects of this product or an identical or substantially similar product, or one or more of the ingredients in this product; and (2) is a type of 

data that would be required to be submitted under the data requirements 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 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 stuqY...Elitller: (a) I am 

the original data submitter; (b) I have obtained the written permission of the original data submitter to use this study in,~uppprt of this 

application; (c) all periods of eligibility for compensation have expired for the study; (d) the study is in the public literatt.re; or (e) I have 

notified in writing the company that submitted the study and have offered 0) to pay compensation to the extent required by'sections 

3(c)(1)(F) and/or 3(c)(2)(8) of FIFRA; and (ii) to commence negotiations to determine the amount and terms ;':lfcompensation, 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 cUIllpensat!dn ~rl(> evidence of 

their delivery in accordance with sections 3(c)(1)(F) and/or 3(c)(2](B) of FIFRA are available and will be b6~lflid;ed to thb'clgelICY upon 

request. Should I fail to produce such evidence to the Agency upon request, I understand that the Agem .• ) Inoy initiate action to deny, 

cancel or suspend the registration of my product in confonnity with FIFRA. ". , . '" ( 

I certify that the statements I have made on this form and all attachments to it are true, accurate and cor.\plex..1 

acknowledge that any knowingly false or misleading statements may be punishable by fine or imprisonment or b'o~h':J:1'der 

applicable law. 

Signature 

\3~c......,C/O~ Date Typed or Printed Name and Title 

2/19/09 Bill Washburn, Regulatory Manager 

EPA Form 8570 . . 34 (9 97) ElectrOniC and Paper versions available. Submit only Paper version . 
49

Pfeas~ ~;_~~~QA-

, reverse before comple -' fon». ! 1 Approved, OMB No. 2070-0060, Approval I 

'" EPA United States 0 Registration opp Identifier Number 

0 Environmental Protection Agency o Amendment 

DC 20460 

Application for Pesticide - Section I 

1. 2. 3. I , , I 

4. D Restricted 

145(; ~~# DNone 

I 

5. Neme"d. "f U 6. Expedited . In i I FIFRA Section 

Arysta lifeScience North America, llC 

(b)(I), my product is similar or identical in composition and labeling 

to: 

15401 Weston Parkway, Suite 150 EPA Reg. No. 

Cary, NC 27513 

Product Name 

n Cheok if/hi' i, a new add,." 

Section -II 

Amendment - Explain below. Final printed labels in response to Agency letter dated 

Resubmission in response to Agency letter dated __ 

Notification - EXPlain' below. 

) "Me Too" Application 

Other - EX~I~in below 

A" : 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 

~'" iI i I y:!! :tee Soloble Type of I 

Yes' Ye, 

rx 

y., Metal 

No No I No Plastic 

I y.,' No. per Ye," No. per Glass 

*Certification must Unit Packaging wgt. container Package wgt. container Paper 

be --,:: .= I I 4. SI .. ,,) I OOf~ [Zl Label D Container On Label 

2.5 gal., 5.0 gal., and 30 gal. I OolabeUno , pcodoct 

6. o Whloh Label I, Affi"d to Pmdo" o Other 

I 

II 

Section -IV 

1. Contact Point (Complele items direclfy below for I , , , " fo pmo." !hi, 

Name ITllle " :: 0 e Alea 

BILL WASHBURN REGULATORY MANAGER Code) 

6. I I 

I certify that the statements I have made on Ihis form and all attachments thereto are true, accurate and complet3'. 'I 

oode, 

that any knowingly false or misleading slatemenl may be punishable by fine or imprisonment or bdth (~t"mped) U I law. .. 2:- ~ET~~LATORY MANAGER 

, <2,' M f • ""~(10. 

~1~r::;JNeme 5. Date . " 

WASHBURN 2/24/09 . - ., 

EPA 1 ,Rev. 8-94) I Whlte- EPA Flte Copy U 
50 -(I\iOIHu11.n'; 'be, 

United States Environmental Protection 

Agency WashingtDn, D.C. 20460 

REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE 

INSTRucnONS: Please type or print in ink. Please read carefully the attached instructions and supply 1he information requested on this form. 

Use additional sheet(s) If necessary. 

1. Company Name and Address 2. Case # and Name 3. Dale and Type of DCI 

ARYSTA LlFESCIENCE NORTH AMEAICA CORPOR) 4092 Thidiazuron 08-May-2008 

15401 WESTON PARKWAY, SUITE 150 PRODUCT SPECIF

CAAY, NC 27513 ID # PDCI-120301

EPA Reg. No. 66330-334 

4. Guideline 5. Study Tille p 6. Use 7. Test 

Requirement R Progress Pattern Substance 

0 Reports Number T 0 

c 

0 

L 1 2 3 

Erod!,!et Cheml!;l:t!:ll 

Chemical) 

830.1550 , ProductlderrlNy and composition (1) A, B, C, D, E, F, G, H, I, TGAI/MP/EP 

J. K. L, M, N, 0 

... 

830:1800 / Descrip1ion of materials' used to produce 1he product· (2)' A, B, C,'D;'E', 'F;'G, H, I, TGAl/MP/EP:: .,-, 

_ J';·K, L, M; N; _0 __ 

830.1620 Description of production process (3) A, B, C, D, E, F, G, H, I, TGAI 

I J, K, L, M, N, 0 830.1650 . Descriplion'o(formi:ilalion proc_ess (4) A, B, C, D, 'E, 'F,_G; i{ i, MP/EP_ .- 

"" .. 

-- J, K, L"ryJ, __ . _ .- .. ------ 

830.1670 , Discussion of lonnation of Impurities (5) A, B, C, D, E, F, G, H, I, TGAI/MP/EP 

J, K, L, M, N, 0 

830,1700---- Prelll'ninary ,inalysis 

. _, (6 .7 ,8) 

• 

. A;'B.C; D,-'E, F, G, H, I, TGAI 

.. N, Q, ... _ .. --

830.1750 V Certified limits (9,10) A. B, C, D, E, F, G, H. I. TGAI/MP/EP 

J. K. L. M. N, 0 

Enforcement'arialitlCiilmeihod (11) 

••• 

. A, B;C, D;-E,-F;'G;'H, I, TGAI/MP/EP"_ ," 

--. -- .---. I . J, K,:_l.,}J),:_Ni.O __ 

830.6302 Color (19) A, B, C, D. E. F. G, H.I, TGAIIMP/EP 

•• I J.K,L,M,N,O 830.63-03'; v"""- PhySical state ,-- .. ,,,."'" .. (22) _."" E,_F,"G:'f-(f,' TGAIIMPJEP":' 

, ... •• "."' . -""", --. . ,,0, .... "" __ • - -- --,. .-." ... l, :N, 0 __ .. ,::. ,,-, " :-,.,,- .. --' , 

830.6304 Odor (23) A, B, C, D, E, F, G, H, I. TGAI/MP/EP 

J, K, L, M. N, 0 

10. Certifjcalion I certify that 1he statements made on this all attachmerrls are true, accurate, and complete. I acknowledge thai any 11. Date 

knowingly false or misleading statement may be punishable by e, or both under appflcable la:v 

Signature and Tille of Company's Authorized Representalive JtJ DC\-':) 'Pe'/:,vtciO<l1 W,o. flC&er' 

12. Name of Company A. "I sic. SC'<"ace Nod-\" ('tiN:>' iCc, LLC 13. Phone Numbe
51

United States Environmental Protection 

Agency Washington, D,C. 20460 

REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE 

INSTRUCTIONS: Please type or print in ink. Please read carefully the attached instruclions and supply the information requested on this form. 

Use additional sheet{s) II necessary. 

1. Company Name and Address 2. Case # and Name 3. Date and Type of DC

ARYSTA LlFESCIENCE NORTH AMERICA CORPOR} 4092 Thidiazuron OB-May-2008 

15401 WESTON PARKWAY, SUITE 150 PRODUCT SPECI

CARY, NC 27513 

EPA Reg. No. 66330-334 

10 # PDCI-12030

4. Guideline 5. Study Tille p 6. Use 7. Test 

R Progress Requirement 0 Reports Pattem Substance 

Number T 

0 

C 

0 

L ( 2 3 

830.6313 StabffitY to sunlight, normal anifefevated (f2,13) A, B, C, 0, E,-F','G, H'-I; TGAI 

temperatures, metals, i(ms .... 

. . J, K, L, M, N,D 

830.6314 v Oxidizing or reducing action (14) A, B, C, D, E, F, G, H, I, MP/EP 

J, K, L, M, N, 0 

830.6315 -v. Flammability (IS) '. A, B, C, D, E,-F, G, HI, MP/EP- 

. . 

J, K, L, M, N, 0. 

830.6316 Explodabllity (16) A, B, C, 0, E, F, G, H, I, MP/EP 

J, K, L, M, N, 0 

830.6317 Storage stability 01 product (1'7)' .... - A; s; C; b; E. F,_G, H, I, MP/EP 

J-.KLL,_M,_N,_O" 

830.63t9 MiscibUity (18) A, B, C, 0, E, F, G, H, I, MP/EP 

J, K, L M, N, ° 

Cor-rOSion- characterIstics: (2'Oj"' • A, B,-C,'D, E, F, G, H, I, MP1EP' " 

830.6320 ........ 

--" ""- K, L. M, _N, 0. - 

830.6321 Dielectric breakdown voltage (21) A, B, C, 0, E, F, G, H, I, MP/EP 

J, K, L, M, N, D 

'v'_ pH of water solutloriflor' su.iibensions (24,25) A, B, C, D, E.; F;'o;-H; '1;- TGAI/MP/EP 

J, K, (,M, N,O. . ......... 

"" "'""""" -'"'--- "" ""-, - --" ... 

830.7050 UVNisible absorption A, B, C, D, E, F, G, H, I, TGAI/PAI 

J,K,L,M,N,D 

830)100 

. ....... \itSC:,osity (26) .,. ' . I "" A,:S,'C;-D, E, F,_G,-H, I; MPiEP 

.. 

......... " .. -, _._." .......... -- .. '- _.,.- ----" -.. ,,,"',._"" ,- ... "''''' !<, l,., M,.N, 0 __ ::",, __ - _:_ "._",,--- . 

830.7200 Melling pointlmelting range (27 .28) A, B, C, D, E, F, G, H, I, TGAI 

J, K, L, M, N, 0 

Initial to indicate certification as to information on this page \b:v Date (full text of certiilcation is on page one). 
52 

United States Environmental Protection 

Agency Washington, D.C. 20460 

REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE 

INSTRUCTIONS: Please type or print in ink. Please read caretully the attached instructions and supply the information requested on this torm. 

Use additional sheet(s) if necessary. 

1. Company Name and Address 2. Case # and Name 3. Date and Type ot DCI 

ARySTA UFESCIENCE NORTH AMERICA CORPORI 4092 Thidiazuron 08-May-2008 

15401 WESTON PARKWAY, SUITE 150 PRODUCT SPECIF

CARY, NC 27513 ID # PDCI-120301

EPA Reg. No. 66330-334 

4. Guideline 5. Study Tille P 6. Use 7. Test 

Requirement 0 Pattern Substance 

Number T epo s 

o 

g/-..--r--I L 1 2 3 

830.7220 80iliri"g'PoinVboliing range (2"9' ,30)' A"s, C, D,-E, F, 13, H, I, TGAI 

I.. J, K, L, M, N, 0 .' ..... 

830.7300 V Densitylrelalive density (31 ,32) A, B, C, D, E, F, G, H, I, TGAI/MP/EP 

J, K, L, M, N, 0 

830.7370 Dissociation constant in water (42,43) " - _:_ _ A, B, C"D, E, F, G;'H,'I. TGAI or 'PAl 

". _.. ..,_., ,._ _.:." J;K, L, M, N, 0- 

830.7550 Partition coefficient (n-octanoVwater), shake flask (44) A, B, C, D, E, F, G, H, I, TGAI/PAI 

method J, K, L, M, N, 0 

830.7570 . pi.:rtitkin coe'fflC:rent (n-octanoVwater), eStirmrtkin by" (4-5)" I, "" I"" A, 8; C, D, E, F, 13, H, I, TGAI/PAI 

__ 

" .. J, K, L" M, N, 0 -

830.7840 Water solubility: Column elution method, shake flask (46) A, B, C, D, E, F, 13, H, I, TGAI or PAl 

method J, K, L, M, N, 0 

830:7860 Water solubility, generaior colifmn method (47) ". --_, A. B; C, D,- E; F; "13", lU; T<3.6."( 

_ 

... 

__ 

. 

___ 

.' .. '_ "' k .. M"N,"P:: _ _,__ 

830.7950 Vapor pressure (48 ,49) A, S, C, D, E, F, 13, H, I, TGAI or PAl 

J, K, L, M, N, 0 

Toxicolo 1\;.'0:11:11.-", Ir men s converiticiiiai"cit'mf lie": _, ,I::::: 1 "'-I::::;: ;:: 

. ........ .'. '. '. ...... I.,. ....

870.1100 Acute Oral Toxicity (36) A, B, C, D, E, F, G, H, I, TGAI,EP,dilute EP? 

J, K, L, M, N, 0 

870.1200' :- Acute dermal toxicity --,- ""(33 :34),_ - _ /': ....... --- 13, H,.I, T<3:Ai;"EP;cfjiute __ E'P'?

1"::,;,<:- _. ..- - .. ',' , , 

870. t300 Acute inhalation toxicity (35) A, B, C, D, E, F, 13, H, I, TGAI & EP 

J, K, L, M, N, 0 

Initial to indicate certilication as to Inrormation on this page , Date O'{ 

(full text of certiticalion is on page one). VIJ-J 0 
53

United States Environmental Protection 

Agency Washington, D.C. 20460 

REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE 

INSTRUCTIONS: Please type or print in ink. Please read carefully the attached instruclions and supply the information requested on this form. 

Use additional sheet(s) if necessary. 

1. Company Name and Address 2. Case # and Name 3. Date and Type of DCI 

ARYSTA LlFESCIENCE NORTH AMERICA CORPORI 4092 Thidiazuron OB-May-200B 

15401 WESTON PARKWAY, SUITE 150 PRODUCT SPECIF

CARY, NC 27513 10 # PDCI-120301-

EPA Reg. No. 66330-334 

4. Guideline 5. Study TItle p 6. Use 7. Test 

R Progress Requirement 0 Reports Pattern Substance 

Number T 

0 

C 

0 

L 1 2 3 

870.2400 Acute eye irritation " ""(37) I A, B, C, D, E, F, G, H; I, TGAI & EP I . N,O' 

870.2500 Acute dermal irritation (38,39) A, B, C, 0, E, F, G, H, I, TGAI & EP 

. I 

J, K, L, M, N, 0 

870.2600 Skin sensitization .. (40,41) Aj-B, C, 0, E, F, 'G,'H; I, TGAI & EP 

,,'" J,K, L, M. N. 0 

.. 

Inilialto indicate certification as to information on this page Qou Date (full text of certification is on page one). 
54

atement of Formula may be entitled to confidential treatment*