# EPA Registration Number
66330-324 Vol. 3

### Date: 111411 0

Reg. No.: 066330-00324 Product Name: ThidiazlITon Technical

PM NamelNumber: Kathryn Montague, PM 23

Primary Reviewer: John Dupuy ./ Secondary Reviewer: 

## Mark Pep' 

# d to 

# !1-iL1w**~**

New label: No pin punch date or stamped date given.

Formulation Type: Technical Chemical (OPPIN)

Active Ingredient Assessed: ThidiazuronJPC Code; 120301



### Other ai's in product:
N/A Reregistration Status or Registration Date: N/A

Assessment can be found N:lprbIJabeJI066330/324

lIThe subheading STORAGE should be changed to Pesticide Storage. Other
information is acceptable in accordance with 40 CFR 156.10 and PR Notice 83-3.



### 21 All other labeling can remain as printed.



### 1

### DATE OUT: 02/DEC/09

SUBJECT: PRODUCT CHEMISTRY REVIEW OF: TGAI [x): 

### MUP [): EUP [) BARCODE NO.: 371389 REG.IFILE SYMBOL NO.: 66330-324 PRODUCT NAME: Thidiazuron Technical MRID NO.: 478608-01, 456019-02. -03 COMPANY NAME: Arysta LifeScience North America, LLC ACTION CODE: 675

FROM: Shirley H.

# Ke~l, Environmental Protection 

## speCialistJl,;J 

# f (/ C

Product Chemistry Team

# f~7 

# CvJ\..

RMIB V iPRD (7508P)

TO: Barbara Briscoe, CRM Risk Management and Implementation Branch V
Pesticide Re-evaluation Division (7508P)



### INTRODUCTION:

With this resubmission in response to our review dated 

### 8113/09, Barcode No. 361487, the registrant provided
MRlD No. 478608-01 and a letter, dated 9/10/09, indicating that the data in MRID Nos. 456019-02 and -03 should be used to support the basic CSF, dated 6/29/09. The registrant is requesting FIFRA Section 4 reregistration ofThidiazuron Technical, EPA Reg. No. 66330-324.



### FINDINGS:

I. EPA Reg. No. 66330-324 is a technical grade active ingredient containing Thidiazuron at a label claim
nominal concentration of98.3%.

2. The registrant's letter, dated 9/10/09, indicates that the data from the preliminary analysis in MRlD No.
471708-0 I support the alternate formulation dated 6/29/09 and that the data in MRlD Nos. 456019-02 and -03 support the basic formulation dated 6/29/09. No alternate formulation was submitted for review. MRlD No.
471708-0 I entitled 

### Preliminary Analysis and Enforcement Analytical Method of Thidiazuron TGAI does not

say that the analysis was carried out for the alternate formulation. In the previous review MRlD No. 471708- 

# o

I was used to support the basic formltiation, and it was found that the amounts of impurities presented in the
CSF are not consistent with the values obtained from the preliminary analysis. In the current review, the
results of 5 lots analysis reported in MRlD No. 456019-03 are found to be consistent with the amounts of the
active ingredient and the impurities indicated in the basic CSF. The basic CSF, dated 6/29/07, is acceptable.
The upper and lower certified limits for the active ingredient and the upper certified limits for the impurities

are acceptable as per 40 CFR 158.175(b)(2).

3. MRlD No. 478608-0 I reports the solubility of Thidiazuron Technical in organic solvents. The requirements
of Guideline 830.7840 are satisfied.



### CONCLUSIONS:

The registrant has now satisfied the product chemistry data requirements for the reregistration of EPA Reg. No.66330-324.



## 1

### Product Chemistry Data Subgroup A: Series 830.1550

- 830.1800 (40 CFR 158.155 -158.180)
Product Identity, Composition, and Analysis

GUIDELINE REFERENCE 40 CFR 

### § MRIDNumber Data NO. 

### Fulfilled (GRNJ/ TITLE 830



### .1670 Discussion of Formation of 158.340 456019-02 Y 

### Impurities

.1700 Preliminary Analysis 158.345 456019-03 Y



### .1750 Certified Limits 158.350 CSF (6/29/07) Y



### Subgroup B: Series 830.6302 -7950 (40 CFR 158.190) PI . I d Ch . I P f



### uyslCa an emlca ro 

### er les
GUIDELINE VALUE OR QUALITATIVE MRlD 

### Data REFERENCE NO. 

### Fulfilled (GRNJ/ TITLE 830 DESCRlPTION 

### Number

.7840 Water and Solvent Shake flask method: 468252-01 

### y Solubility Time of a1!itation Water solubilitv ial200C 

### & 

### After I day 0.0073 giL



### After 2 

### day 0.0089 giL 

### 478608-01



### After 3 

### dav 0.0085 gIL 

### Average 0.0082 giL



### Or anic Solvent Solubilit a 20 C 

### Hexane 0.002 giL 

### Methanol 4.2 

### Dichloromethanc 0.003 gIL 

### Toluene 0.4 L 

### Acetone 6.67 L 

### Ethyl Acetate 1.1 giL 

### Explanations: Y Requtrement fulfilled



### 2

### Confidential Appendix

The results ofHPLC analysis of five lots ofThidiazuron TGAI reported in MRID No. 456019-03 are summarized in the following table.

Compounds (w/w%) Lot # Lot # 

# IA,. Lot # Lot# Mean 200001202 200001204 200001206 200001208 200001220 

### Thidiazuron 99 97,6 97.4 98.8 98,7 98.3



### 3

### DATE OUT: 13/AUG/09

SUBJECT: PRODUCT CHEMISTRY REVIEW OF: TGAI IxJ: MUP I J: EUP I J BARCODE NO.: 361487 REG.IFILE SYMBOL NO.: 66330·324 PRODUCT NAME: Thidiazuron Technical MRID NOS.:**471708~01** 

### ,**468252~O** 

### 1 , 4560**19~O** 

### 1 , -02, -03. -04 

### COMPANY NAME: Arysta 

### LifeScience North America. LLC ACTION CODE: 674

FROM:



### TO: Shirley H, Keel, Environmental Protection Specialist
Product Chemistry Team [sign. S. Keel, 8/13/09] PRBISRRD 

### (7508P)

BarbaraBriscoe, CRM
Product Reregistration Branch Special Review and Reregistration Division (7508P)



### lNTRODUCTION:

A Reregistration Eligibility Decision (RED), Case number 4092, was issued in September, 2005 for the Active lngredient (AI) Thidiazuron [1-phenyl-3-(1,2,3-thidiazol-5-yl)urea]. 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 of Thidiazuron Technical, EPA Reg. No.**66330~324,** the registrant submitted a Confidential Statement of Fonnula (CSF), a basic formulation,
dated 

### 6/29/07; a draft label (no**pin~punched** date); and product chemistry data in MRID numbers 471708·01, 

### 468252·01,456019·01, ·02, ·03 and ·04.

F1NDlNGS:

l. EPA Reg. No. 66330-324 is a technical grade active ingredient containing Thidiazuron at a label claim
nominal concentration of98.3%.

2. The CSF for the basic formulation, dated 

### 6/29/07, is not acceptable because the amounts of impurities indicated in the CSF are not consistent 

### with the values reported 

### in 

## MRID No.

471708·01 (Preliminary Analysis). Other infonnation 

### in the CSF is acceptable. The nominal
concentration of the active ingredient agrees 

### with that on the label, meeting the requirements of

PR Notice**91~2.** The upper and lower certified limits for the active ingredient are acceptable as per 40


### CFR 158.175 (b)(2).

3. The product chemistry data reported in MRID Nos.**456019~01,** -02, -03 and -04 which pertain to product identity and composition, description of materials used to produce the product, description of production process, discussion of fonnation of impurities, preliminary analysis, enforcement analytical methods, color, physical state, odor, stability to nonnal and elevated temperatures, metals, and metal ions, pH, UV/visible absorption, melting point/melting range, density, dissociation constants in water, partition coefficient**(n~octanoVwater)** and vapor pressure were previously submitted to the Registration
Division (RD) 

### in connection with the registration of the subject product and reviewed by Shyam Mathur

on 

### 8119/02 under Barcode No. 0283364. 

### PRBISRRD concurs with RD's review and concludes that
these data are acceptable to support the reregistration of the subject product



### 1

### 4. MRID No, 471708-0 I reports the results of a new preliminary analysis. Guideline 830.1700 is satisfied.

5. MRID No, 468252-01 reports the water solubility ofThidiazuron Technical, but no data have been
submitted for the solubility in organic solvents. The requirements of Guideline 830.7840 have not been

met completely.

6. The product chemistry statements of the draft label are acceptable. The Ingredient statement is in compliance with the requirements of 40 CPR 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.



### 7, The Storage and Disposal statements of the draft label needs a minor revision. The subheading
STORAGE should be changed to 

### Pesticide Storage. This recommendation should be addressed during the label review. Other information is 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 acceptability of these statements to the Registration Division,



### CONCLUSIONS:

Except for Findings #2 and #5, the registrant has satisfied product chemistry data requirements for the reregistration of EPA Reg. No, 66330-324,



### 2

### Product Chemistry Data Subgroup A: Series 830.1550

- 830.1800 (40 CFR 158.155 • 158.180)


### Product Identity, Composition, and Analysis

GUIDELINE REFERENCE 40 CFR 

### § MRIDNumber Data NO. 

### Fulfilled (GRN)/ TITLE 830



### .1550 Product Identity and 158.320 CSF (6/29/07) Y 

### Composition

.1700 Preliminary Analysis 158.345 471708·01 Y



### .1750 Certified Limits 158.350 471708-01 & 

### CSF (6/29/07) U



### Subgroup B: Series 830.6302**~** 

### 7950 (40 CFR 158.190) Pb' dCb' IP



### hYSical an emlca ro erties GUIDELINE VALUE OR QUALITATIVE MRID 

### Data REFERENCE NO. DESCRIPTION 

### Number Fulfilled (GRN)/ TITLE 830



### .6317 Storage Stability Not required for TGAI N/A



### .6320 Corrosion Not required for TGAI N/A 

### Characteristics

.7840 Water and Solvent Shake flask method: 468252-01 I 

### Solubility Time 

## or agitation Water solubility @2ooc



### After 1 day 0.0073 

### gIL



### After 2 day 0.0089 

### gIL

After 3 daY 0.0085 

### gIL


### Average 0.0082 g/L



# - ExplanatIOns. Y 

### ReqUirement fulfilled, **N/A** 

### Not applicable, U Upgradable, I"" 

### Incomplete or in 

### progress.



### 3

### Confidential Appendix

830-1700 Preliminary Analysis
The results of a new preliminary analysis of 5 representative batches ofThidiazuron Technical manufactured in

are presented in the following table (MRID Nos. 471708-01, study completed on 6111/07).

Compound Batch Batch Batch Batch Batch

TDZlOO70122 TDZlO(l7012) TDZlOO70124 TDZ20070125 TDZ20070126

(% w/w) (%**w/~)** 

### .(% w/w) (% w/w) (% w/w) Thidiazuron 982 98.0 98.4 98.1 97.8



### 4

### UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, D.C. 20460

February 17, 2009

MEMORANDUM:

Subject:



### From:

To:



### Applicant: EPA Reg. No.: 66330-324/ThidiazuronTechnical

DP Barcode: 361488
Case No.: 4092

Marianne Lewis, Biologist [sign. M.Lewis 

### 2I17/09J


### Product Reregistration Branch 

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

Barbara Briscoe, CRM
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. 66330-324 LABEL:

Active lngredient(s): OFFICE OF PREVENTION, PESTICIDES AND TOXIC SUBSTANCES



### % 

### bywt.



## Thidiazuron

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

................................... , ............................................. . 98.30%
1.70%


### 100.00% Inert Ingredient(s):

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

### BACKGROUND: In 

### the 8 month response to the Thidiazuron RED, the registrant is citing acute toxicity studies to support the reregistration of their 

### product, EPA Reg. No. 66330-324. The
MRID's are as follows: 456019-05 (81-1), 456019-06 (81-2), 456019-07 (81-3), 456019-08 (81- 4),456019-09 (81-5), 456019-10 (81-6). The studies were conducted by Stillmeadow, Inc. The



### test material used in each of the 

### studies was the subject product. These studies were reviewed and found to be acceptable by TRBIRD on 8/27/02. After reviewing the studies, PRB concurs with TRB's findings.

RECOMMENDATIONS:



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

### Reg.
No. 66330-324.



### The acute toxicity profile for EPA Reg. No. 66330-324 is currently:

Acute Oral N 

### Cited (LD;o > 

### 5050 mg/kg) 

### Acute Dennal IV Cited (LD" > 

### 5050 mglkg) 

### Acute Inhalation IV Cited (LC,. > 

### 2.40 mg/L) Primary Eye IV Cited 

### Primary Dennal N Cited 

### Skin Sensitization non sensitizer Cited



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

### LABELING:

ID #: 066330-00324 THIDIAZURON TECHNICAL

SIGNAL WORD*: CAUTION

HAZARDS TO HUMANS AND DOMESTIC ANIMALS':



## +

The designation of Personal Protective Equipment (PPE) for manufacturing use products does

not 

## fall under the jurisdiction of EPA, therefore, PPE has not been specified for this product.

FIRST AID*:

IF SWALLOWED: Call a poison control center or doctor immediately for treatment advice. Have person sip a glass afwater 

## 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 afwater 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: Due to the acute toxicity categories received this product is not required to have a Signal Word, HHDA, or First Aid Statements. However, if the registrant
wishes to retain the First Aid statements and/or Signal Word then they must be identical to the
above statements.

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

### 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.

# ~ Arysta LifeScience

September 16, 2009

Ms. Patricia L. 

### Moe, Chief Document Processing Desk Product Reregistration Branch Special Rev"lew and Rereg'lstration Division (7508P) U,S. Environmental Protection Agency One Potomac Yard, Room 5-4900 2777 South Crystal Drive Arlington, VA 22202

Subject: THIDIAZURON TECHNICAL EPA Reg. No. 66330·324 

### Submission of Data per Agency Letter dated 9/1/09

Dear Ms. Moe,

Please find enclosed the following documents in support of Thidiazuron Technical,
EPA 

### reg. No. 66330-324:

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

One copy of EPA Form 8570-1 (Application for Registration Amendment) dated September 16, is enclosed. This data is submitted in response to the Agency letter dated September 1, 2009.

2. Bib!iography of Submitted Studies

One copy of the Bibliography of Submitted Studies (transmitta! document) describing the submitted data in support of this registration is enc!osed.

3. Study Reports

Three bound and labe!ed copies of the study described in the Bibliography of Submitted Studies are enc!osed.



### Should you have any questions in regards to this submission or request, p!ease do
not heSitate to contact me by**e~mail** 

### at bill.washburn@arystalifescience.com or by phone at 901-432-5118.



### Sincerely,

Bill Washburn Regulatory Manager

Arysta UfeScience North America 15401 weston Parkway. Suite 150. Cary. NC 27S13 Phone 919-678-4900 Fax 919-678--2194 www.arystatrfescience.com



### ••••


## • • • • • 478808·00ArystaLifeScienceNorthAmerica,LLC15401WestonParkway,Suite 150Cary.NorthCarolina27513ProductName:EPARegistrationNumber:PurposeofSubmission:DateofSubmission:BIBLIOGRAPHYOFSUBMITTEDSTUDIESThidiazuronTechnical66330-324ApplicationforAmendedRegistrationSeptember17,2009SolubilityofThidiazuronTechnicalinOrganicSolventsAR-0923830.7840Page1of147880801---1-1-----II

## Arysta LifeScience

Ms. Patricia L. 

### Moe, Chief Document Processing Desk Product Reregistration Branch Special Review and Reregistration Division (7508P) U,S. Environmental Protection Agency One Potomac Yard, Room 5-4900 2777 South Crystal Drive Arlington, VA 22202



### Subject: THIDIAZURDN TECHNICAL EPA Reg. No.**66330~324** 

### September 10, 2009

Response to Agency Letter Dated September 1, 2009

Dear Ms. Moe,

In regards to the Agency letter and Product Chemistry Review mentioned above,
copy attached, I would offer the following;

Finding 

### #2 in the Product Chemistry Review makes reference to MRID No. 471708-1
and that the information in this report does not support the basic formulation dated 6/29/07. Because of this the CSF is deemed unacceptable. MRID No. 471708-01 does not support the basic formulation, it supports the alternate formulation dated 6/29/07. The product chemistry found in MRID Nos. 456019-02 and 456019-03 supports the basic formulation dated 6/29/09.

Finding 

### #5 in the Product Chemistry Review indicates that MRID No. 468252-01
does establish the water solubility of Thidiazuron Technical, but does not address solubility in organic solvents. I have requested a report to fulfill this data requirement from our lab and have been told the soonest this report can be available is September 30, 2009. I am requesting an extension of the deadline given in the above mentioned letter in order ,to give the laboratory sufficient time to submit a report. I would request an extension to September 30, 2009 to fulfill this data request.

Should you have any questions in regards to this submission or request, please do
not hesitate to contact me bye-mail at bill.washburn@arystalifescience.com or by phone at 901-432-5118.

Sincerely,

Bill Washburn Regulatory Manager

Arysla UfeScience North America 15401 Weston Parkway, Suile 150, Cary, NC 27513 Phone 919-678-4900 Fax 919-678-2194 www.aryslalifescience.comUNITED STATES**P-~~1:'AL** SERVICE 

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### UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, 

### D.C. 20460

OFFICE OF PREVENTION, PESTICIDES AND TOXIC SUBSTANCES 

### CERTIFIED MAIL 

# SEP 0 11009

Bill Washburn Arysta LifeScience 

### 15401 Weston Parkway, Suite 150 Cary, NC 27513



### SUBJECT, 

### Thidiazuron Reregistration Eligibility Decision (RED), Review of Product Chemistry Data, EPA Registration Number 66330-324

Dear Mr. Washburn:



### Your submission of product chemistry data in response to the Thidiazuron RED, Product Specific Data Call-In Notice has been reviewed. The Agency has made the following


### determination:

• The Confidential Statement of Formula (CSF) for the basic formulation
dated 6/29/07 is not acceptable and must be revised. You may refer to the
enclosed Data Evaluation Record for detailed information on revising

your CSF.

• The data submitted in MRJD number 46825201 for water solubility does

not satisfy the guideline requirement because no data were submitted for
the solubility in organic solvents. Additional data are required.

With exception to the data requirements indicated above, the product chemistry data you submitted are acceptable. The revised CSF and the water solubility data

are due within 10 days from your receipt of this letter. Failure to submit data by this due
date may result in your receiving a Notice of Intent to Suspend your product's registration.
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

### UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

CERTIFIED MAIL

Bill Washburn Arysta LifeScience 

### 15401 Weston Parkway, Suite 150 Cary, NC 27513 

## SEP 0 1 700g

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

### Chemistry Data, EPA Registration Number 66330-324

Dear Mr. Washburn:



### Your submission of product chemistry data in response to the Thidiazuron RED,
Product Specific Data Call-In Notice has been reviewed. The Agency has made the following 

### determination:

• The Confidential Statement of Formula (CSF) for the basic formulation


### dated 6/29/07 is not acceptable and must be revised. You may refer to the enclosed Data Evaluation Record for detailed information on revising

your CSF.



### • The data submitted in MRID number 46825201 for water solubility does

not satisfy the guideline requirement because no data were submitted for the solubility in organic solvents. Additional data are required.

With exception to the data requirements indicated above, the product chemistry data you submitted are acceptable. The revised CSF and the water solubility data

are due within 10 days from your receipt of this letter. Failure to submit data by this due date may result in your receiving a Notice of Intent to Suspend your product's registration.
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 

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### Ito xi c 

### t 

### y 

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delillel)'. To ob)aln Return Receipt sl?l'ik:e. pieaee complete olnel attach e Return Receipl II'S Form 381 t) 10 the arti::le 600 add appncable postage to**co~er** the tee. Ernlor$e mailplece "Reltlm Receipt**~quesled".** To receive a fee wai'lerf(lf

a**dup!(~\e** reluin receipt, a USPS$ postmarK on your CeJtilled Mall receipt is reqUIred. 

## = for an additional lee, delivery may be restricted to the addressee or

addressee's au)horized Cinant. Advise \lie clerk or mark the mailpiece wIth the endofl>emefl! "Aefl/rict<ld Delivery".

11\ II a postmark Of} thOi Certified Mail receipt is desired, please preeent lhe arti,

ele at the post office for postmarking. 11 a postm1lfk Of} the Certified Mail receipt Is no) needed, detach and affix 11'lbe\ with postage and malt.

IMPORTANT: Save this receipl and presenl i1 when making an inquiry.

PS form $800, AU9uzi 2000**(R~ver:;,,>** PSN 75:JO·QN)0().91147

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



## APR 1 3 10D9 OFFICE OF PREVENTION, PESTICIDES AND TOXIC SUBSTANCES



### CERTIFIED MAIL



### Mr. Bill Washburn Regulatory Manager Arysta LifeScience 

### 15401 Weston Parkway, Suite 150 Cary, NC 27513

SUBJECT: Thidiazuron Reregistration Eligibility Decision (RED), Review of Acute Toxicity Data, EPA Registration Number 66330-324

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**66330~324,** 

### which were previously reviewed and 

### determined to be acceptable.

The acute toxicity profile for EPA Registration No. 66330-324 is currently:

Guideline Study Toxicity Category Classification



### 81,1 Acute Oral 

### IV Acceptable


### 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 Skin Sensitization non sensitizer Acceptable

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


### Sincerely, 

# ,-OcL0vL**~'o( ~**  

# ,
Patricia L. 

### Moe, Chief
Product Reregistration Branch Special Review and Reregistration Division
Enclosure

### UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

CERTIFIED MAIL

Mr. Bill Washburn Regulatory Manager Arysta LifeScience


### 15401 Weston Parkway, Suite 150 Cary, NC 27513 

# APR 1 3 1009

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

### Toxicity Data, EPA Registration Number 66330-324

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 66330-324, which were previously reviewed and
determined to be acceptable

..

The acute toxicity profile for EPA Registration No. 66330-324 is currently:

Guideline Study Toxicity Category 

### Classification

81-1 Acute Oral 

## IV Acceptable
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 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
Enclosure

CONCURENCES



### 7508/' 

## 7Jo-S/' 'i,y

Briscoe

# ~ 4-3-09 p. 

# :..9**~** EPA FORM 1 

## 0-,. ( 190) Printed on Recycled Paper OFFICIAL FILE COpy

# ~ Arysta LifeScience

VIA FEDEX DELIVERY (Tracking No. 7972 7915 8422)

Ms. Barbara 

### L. Briscoe, Chemical Review Manager
Product Reregis1ration 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 Technical.....,,,"] d. EPA Reg. No. 66330.3!1f'**~'>:>'-'7**



### 8·Month Response to Data Call·ln dated 

### 5/08/08 January 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 dimethoate 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 24,2009.

2. EPA Form 8570·4 

### (Confidential Statement of Formula)

Two copies of EPA Form 8570-4 

### (Confidential Statement of 

### Formula) for both the Basic
and Alternate Formulations dated June 29, 2007. These formulations were approved on November 11

, 2007.



### 3. EPA Form 8570-34 

### (Certification with Respect to Citation of Data)

One Copy of EPA Form 8570·34 

### (Cenification wffh Respect to Citation of 

### Data) dated January 24, 2009. We are using the Cite-All Option under the Selec1ive Method and
have checked the General Offer to Pay statement.

Arysla LifeScience North America, LLC 15401 Weston Parkway, Suite 150. Cary, NC 27513 Phone 919·678-4900 Fax 919·678-2194 www.arystalifescience.com , " 

### "

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### ,

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### , , 

### , "",



### , ,

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### ,

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### "



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### Page2of2



### 4. 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.

5. Draft Label for Thidiazuron Technical

Five copies of a draft label for Thidiazuron Technical; one redline copy identified by filename THIDIAZURON TECHNICAU324-112007jREO 

### + 2007-4 Redline.doc 

### and 4 clean copies identified 

### by filename THIDIAZURON TECHNICAL(324-112007)REO 

### + 2007-4 Clean. doc 

### are endosed.

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 Wash burn Regulatory Manager

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



### , , , > , , • >



### ,

" "

, ,',-,

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,"'"oUNrrEDSTATESENVIRONMENTALPROTECTIONAGENCY401MStreet,S.W.WASHINGTON,D.C.20460FormApprovedOMSNo.2070·0060________nActNotice:"andspecialringburdenforthisG-'------"-9theiinformationisestimatedtoaverage0.25hoursperresponseforregistrationactivitiesandO..----",,,,,'",..",andcompletingthenecessaryforms.Sendcommentsregardingtheburdenestimateoranyotheraspectofthiscollectionofinformation,includi.'lJ:,u\oi\J=iiu,''>IU,Donotsendtheformtor .Date,,20099theburdento:Director,UPf-'E..."-ManagementDivision(2137),U.S.EnvironmentalProtectionAgency,401M.:>.VV",Hd:;'B"\jIOJI,UI...LV'+OU,DATAMATRIXEPAReg.No./FileSymbol66330-324jpage1of2ProductArystaIjNorthAmerica,LLC,15401WestonParkway,Suite150,Cary,NC27513Ingredient(s):THIDIAZURON,CASNo.51707·55·2830.1\ACUTET'rCHEM--830A).7840GENERICGilc·ALLIt:-""LLIt:-""LLCITE-ALLIStudyNamefand(ofMaterials,ProductionProcess,FormationofImpurities,PreliminaryAnalysis,CertifiedLimits,AnalyticalMethodflask)IIand(IAcuteIAcuteIPrimarPISkin:WOJ'=)EPAFOfm8570·35(9·97)Eleclron",andPaperversionsavailable.SubmilonlyPaperversion.IMRIDI4560190245601903520280456019054560190645601907456019084560190945601910IIArystaLifeSciCary,NC27513NorthIArystaLifeScienceNorthIArystaLifeScienceNorthIArystaLifeScienceNorthIArystaLifeScienceNorthIArystaLifeScienceNorthArystaLifeScienceNorthArystaLifeScienceNorthArystaUfeScienceNorthArystalife_$cienceNorthBayerCropScienceLLPEPACo.No.264\EPA400-IBASFSparkslLCEPACo.No.t:....n,..IISprayDriftTaskForceEPACo.No.66607"'....,'--'vv'..."I-'v"....eT.F.EPACo.No.71754'"'!o!',......"...oe.o,"",...,,,,y'TaskForce.E:PACo.No.NameandTitle:StatusOwoOwoOwoOwoOwoOWoIWOIwoIwoPayPayPayPayPayPayPayINot,DateBillWashburn,RegulatoryManagerAgencytnternalUseCopy1/24/09.,..UNITEDSTATESENVIRONMENTALPROTECTIONAGENCYFormApprovedOMBNo.2070-00600401MStreet,S.W.WASHINGTON,D.C.20460PapelWorkReductionActNotice;Thepublicreportingburdenforthiscollection01informalionisestimated10average0.25hoursperresponseforregistrationactivitiesand0.25hoursperresponseforreregistrationandspecialreviewactivities,includinglimeforreadingIheinstructionsandcomplelingthenecessaryforms.SendcommentsregardingIheburdenestimateoranyotheraspectofthiscollectionofinformalion,includingsuggestionsforreducingtheburdento:Director,OPPEInformationManagementDivision(2137),U.S.EnvironmentalProtectionAgency,401MStreet.S.W.,Washington,DC20460.Donolsendtheformtothisaddress.DATAMATRIXDateJanuary24,2009EPAReg.No.fFileSymbol66330-324IPage2012Applicant'sfRegistrant'sName&Address:ProductArystaUfeScienceNorthAmerIca,LLC,15401WestonParkway,Suite150,Cary,NC27513TH!DIAZURONTECHNICAL!ngredient(s):THID!AZURON,CASNo.51707·55-2GuidelineReferenceNumberGuidelineStudyNameMR!DNumberSubmitterStatusNoteNationsAgII,LLCp'Y"EPACo.No.72167CITE·ALLSRMChemica!,LTO.Co.p'YEPACo.No.73631CITE-ALLFIFRAEndangeredSpeciesT.F.p'YEPACo.No.73989CITE-ALLAgHandlersExposureTaskForcep'YMemberEPACo.No.75234CITE·ALLGro-Pro,LLCp'YEPACo.No.79676CITE-ALLEtigra,LLCp'YEPACo.No.81959CITE-ALLGenericEndangeredSpeciesT.F.p'YMemberEPACo.No.84653ISignatureINameandTitle:BillWashburn,RegulatoryManagerIDate1/24/09EPAForm8570.35tS-97)EleclrooiCandPaperversIOnSavail.ole.SubmlonlyPaperversion.AgencylolemalUseCopyPlease read instruclions on reverse before com;: !form. m Approved, OMB No. 2070·0060, Apploval

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# .,.,. EPA United States 

## D Registration opp Identifier Number 

# 0 Environmental Protection Agency 

## D Amendment

DC 20460 

### 0

Application for Pesticide**~** Section I

t I Nomboe 2.**EPAPmd~;"** 3. I ;

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Arysta LifeScience North America, LLC to: 

### 15401 Weston Parkway, Suite 

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

### 27513 .


# n Ch"k If "';'-"

, ",w ,ddre" Product Name

Section**~** II

Amendmenl- Explain below. Final printed labels in response 10 Agency leller daled

Resubmission in response 10 Agency letler dated

__ "Me Too" Applicalion 

# " 

# , . 

# , 

# " Other

- EXplain below

: Use I ) IT ". (For i and I 

### 11.)

8-Month Submission in response to Data Call-In dated May 8, 

### 2008,

Section**~** III



# , ;

### ~II 

# ,

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DYes' Yes Yeo Melal 

# IZJ No

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# '"**~~~I~~er** Glass 

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### Certification must Unil Packaging vvgl. wgl. Paper 

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# ~ I I Ii 4. ""'" "e"II, I 

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# ~ On Label 55.0 gal and bulk Onl Ii ; ,pcod,,1

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# ;"~EGULATORY MANAGER Code) , No, (""od, ",eo

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# g." '4:l2-5118

Certification ';6,**~,'e** Ii
I certifylhat lhe statements I have made on this torm and all altachments thereto are Irue, accUiate and complele: I

, thai any knowingly false or misleading statemenl may be punishable by fine or imprisonment or bolh' ""dec,

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### , 2. ; 3. T,"e , 

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# ~-S~L.)=~ REGULATORY MANAGER ,

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# ~,~t":;;~eBURN 5. D"e , 

### , 1/24/09 ,.,',) 

# " 

# , , EPA (Rev. 8-94) I ; ; are obsolete 

# " ' mow-, I , CopyA dOMB Form pprove No. 2070-006'



# -**U~.** 

### ..:0 STATES ENVIRONMENTAL PROTECltON 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**es~mated** 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 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, 40t 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/ File Symbol Arysta LifeScience N. A., LLC, 15401 Weston Parkway, Suite 150, Cary, NC 27513 66330-324

Active Ingredient(s) and/or representative test compound(s): Date Thidiazuron 1124/09

General use pattern(s) (list all those claimed for this product using 40 CFR Part 158) Product Name
Terrestrial, Outdoor, Food Use THIDlAZURON TECHNICAL

NOTE: If your product is a 100% repackaging of another purchased EPA-registered**pro~~t** labeled for all th;).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

. 

## 0 I am responding to a Data Call-In Notice, and have included with this form a list of companies sent offers of compensation {the Data
Matrix form should be used for this purposel.

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

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

## IZI 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 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) 

## IZI 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·ln 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 pennission 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 'tn the publk 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 sections 3(c)(1)(F) and/or 3(c)(2){B) 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){B) 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. I acknowledge that any knowingly false or misleading statements may be punishable by fine or imprisonment or both under applicable law.

Signature

# G.:a...tvOQ~ 

# D.' Typed or Printed Name and Title

1/24/09 

### Bill Washburn, Regulatory Manager

EPA For m 8570 "34 9"97 EI ectronlc an d Pa er bl p versions avalla e. Submit only Paper version.-oUNITEDSTATESENVIRONMENTALPROTECTIONAGENCY401MStreet,S.W.D.C.20460ApprovedOMBNo.207(}-0060average0.25hoursperresponseforregistrationactivitiesandhoursperresponseincludingtimeforreadingtheinstructionsandcompletingthenecessaryforms.Sendcommentsregardingtheburdenestimateoranyotheraspectofthiscollectionreducing[heburdento:Director,OPPEInformationManagementDivision(2137),U.S.EnvironmentalProtectionAgency,401MStreet,S,W.,Washington,DC20460.DATAMATRIXEPAReg,No./FileSymbol66330·324Page1ofProductNorthAmerica,LLC,15401WestonParkway,Suite150,Cary,NC27513THIDIAZURON,CASNo.51707·55·23SignatureNameandTitle:Date1/24/09BillWashburn,RegulatoryManagerEPAForm857p·3519.97)Elcclroo;caodPaperVefSJonsavailabl".SubmitoolyPap"r..""ioo,AgoncyloternalUseCopy'"oUNITEDSTATESENVIRONMENTALPROTECTIONAGENCY401MStreet,S.W.FormApprovedOMSNo.2070.-0060WASHINGTON,D.C.20460perresponselorregistrationactivitiesand0.25hoursperresponseforms.Sendcommentsregardingtheburdenestimateoranyotheraspectofthiscollectionofreducing(2137).U.S.EnvironmentalProtectionAgency,401MStreet,S.w.,Washington,DC20460.DATAMATRIXDate24,20092ofArystaLifeScienceNorthAmerica,LLC,15401WestonParkway,Suite150,Cary,NC27513Product!ngredient(s):THIDIAZURON,CASNo.51707·55·2NameandTitle:BillWashburn,RegulatoryManagerDate1/24/09EPAForm8570·35ts-97)EleclronlcandPa?<"fvem,CID'SubmnoolyPapervermon.AgencyInternalUseCopyPage2of4,UnitedStatesEnvironmentalProtectionOMBApproval2070-0107AgencyWashington,D.C.20460OMBApproval2070-0057REQUIREMENTSSTATUSANDREGISTRANT'SRESPONSEINSTRUCTIONS:Pleasetypeorprintinink.Pleasereadcarefu!!y1heattachedinstructionsandsupplytheinformationrequestedonIhislorm.Useadditionalsheet(s)ifnecessary.i1.CompanyNameandAddress2.Case#andName3.DaleandTypeofDCIandNumberARYSTAlIFESCIENCENORTHAMERICACORPOR)4092Thidiazuron0B-May-200815401WESTONPARKWAY,SUITE150PRODUCTSPECIFIC,,CARY,NC2751310#PDCI-120301-26085EPAReg.No.66330-3244.Guideline5.StudyTitlep6.Use7.Test8.Time9.Registrar':RProgressRequiremenl0ReportsPatternSubstanceFrameResponseNumberT(Months)0c0l123830.6313VSIabHity10sunl"ight,normalandelel/aled(12,13)A;B,C,0,'E,F,G,H,I,TGAJG,lemperatures,melals,andmetallonsJ,K,L,M,N,O, B830.6314Oxidizingorreducingaction/14)A,B,C,0,E,F,G,H,I,MP/EP("J, K,l,M,N,0"830.6315Aammabllily(15)A,B,C,D,E,F,G,H,J,MP/EP("v•J,K,L,M,N,O830.6316vExp!odability(16)A,B,C,0,E,F,G,H,I,MP/EPBC.oJ,K,l,M,N,0"j830.6317StoragestabilitYofproducl(17),A,B,C,0,E,F,G,H,I,MPIEPlb"",J,K,L,M,N,Q,830.6319,Miscibility(18)A,B,C,0,E,F,G,H,I,MPIEPBifJJ,K,l,M,N,0830.632:0vCorrosioncharaCterisllcs(20),A,'B,C,D,E,F,G;14,I,MPJE'PCt>j,K,L,M,N,O830.6321/Dielectricbreakdownvoltage(21)A,B,C,0,E,F,G,H,I,MP/EPJ,K,l,M,N,0B(p830.7000YpHofwalersoruti6nsorsuspen"s'lons(24,2siA,B,C,0,EiF,G,H,J,TGA[IMP/EPf.oJ,.K,L"M,N,,0830.7%0.."UVNisibleabsorptionA,B,C,0,E,F,G,H,I,TGAIIPAIit?J,K,L,M,N,0,-.Viscosity126)A,B;O,D,E,F,G,H'-,f,W/EPB.,'(.,,..J,K,L,,¥,N;O",,,",'.Meltingpoint/meltingrange(27,28)A,B,C,D,E,F,G,H,I,TGAI!,""'J,K,l,M,N,0""" ",".'"""" """ "".""""""Initialtoindicatecertilicationastoinformationon1hispageUuDate'O/e(O?![tuUtextofcertilica1ionisonpageone).Page30f4UnitedStatesEnvironmentalProtectionOMBApproval2070-0107IAgencyWashington,D_C.20460OMBApproval2070-0057REQUIREMENTSSTATUSANDREGISTRANT'SRESPONSEJINSTRUCTIONS:Pleaselypeorprintinink.Pleasereadcarefullytheattachedinstructionsandsupplytheinformationrequestedonthisform.IUseadditionalsheet(s)ifnecessary.!It.CompanyNameandAddress2.Case#andName3.DateandTypeotDCIandNumberARYSTALlFESCIENCENORTHAMERICACORPORI4092ThidiazuronOB-May-200Bi15401WESTONPARKWAY,SUITEt50PRODUCTSPECIFICCARY,NC275t3ID#PDCI-120301-260B5EPAReg.No.66330-3244.Guideline5.StudyTitlep6.Use7.Test8.Time9.Registrant:RequirementRProgressPatternSubstanceFrameResponse0ReportsNumberT(Months)0Ic0iL,23830.7220BoiffngpoinVboffingrange(29,30)A,B,C,D;'E,F,G,H,I,TGAIBtJ>IvIJ,K,L,M,N,O830.7300Density/relativedensity(31.32)A,S,C,D,E,F,G,H,I,TGAIIMP/EPBV,,J,K,L,M,N,0'830.7370IDissociationoonstimlinwater(42,43)A,B,C,D,E,F,G,H,I,J,K,L.f.1,N,0TGAI'orPAl("830.7550,PartitioncoeH'lcient(n'octanollwater),shakeflask(44)A,S,C,D,E,F,G,H,I,TGAI/PAI(gmethodJ,K,L,M,N,0830.7570"Partitioncoefficient(n-octanoVwater),estimationby(451A,B',C;D,E,F,G,H,I,TGAliPAI(0liquidchromatographyJ,K,L,M,N,O830.7840,Watersolubility:Columnelutionmethod.shakeflask(46)A,S,C,D,E,F,G,H,I,TGAIorPAlB(0methodJ,K,L,M,N,0830.7860Watersolubllity,generatorcofumnmethod(471A,B,C,D,E;F,G,H,I,TGAlorPAl!o(0"J,K,830.7950Vaporpressure(48,49)A,S,C,D,E,F,G,H,I,TGAIorPAlIv,J,K,L,M,N,0Rggulr.!!!!!!:Oa-,C2nV!nIi2D;'Id.AcuteOralToxicity(36)A,B,C,D,E,F,G,H,I,TGAI,EP,diluteEP?'(p,J,K,l,M,N,O..870."/2OC.'AcutedermaJtoxicity'(33,34)A,'B,'C,D,E,F,G,H,I;'TGAI,EP,diluteEP?Vi,,(,:,'.-.--,"870.1300Acuteinhalationtoxicity(35)A,B,C,D,E,F,G,H,I,TGAI&EPBCt>..J,K,l,M,N,O,",,....,,,',,,,,,,",, ,,,Initialtoindicatecertificationastoinformationonthispaget:wDate'Of'OroB(fulltextofcertificationISonpageone).Page4of4UnitedStatesEnvironmentalProtectionOMBApproval2070,Ol07AgencyWashington,D.C.20460OMSApproval2070-0057REQUIREMENTSSTATUSANDREGISTRANT'SRESPONSEINSTRUCTIONS:Pleasetypeorprintinink.Pleasereadcarefullytheattachedinstructionsandsupplytheinformationrequestedonthisform.Useadditionalsheet(s)ifnecessary.1.CompanyNameandAddress2.Case/IandName3.DateandTypeofDCIandNumberARYSTALlFESCIENCENORTHAMERICACORPOR}4092Thidiazuron08-May-200815401WESTONPARKWAY,SUITE150PRODUCTSPECIFICCARY,NC2751310#PDCI-120301·26085EPAReg.No.66330-3244.Guideline5.Study Titlep6.Use7.TestB.Time9.RegistrantRProgressRequirement0PatternSubstanceFrameResponseNumberTReports(Months)0c0L,23870.2400Acuteeyeirritation(37)A,S,C,D,E','F,G,H,I,TGAI&EPC.J,K,L,,}.-1,N,0870.2500Acutedermalirritation(38,39)A,S,C,D,E,F,G,H,I,TGAI&EP810J,K,L,M,N,O870.2600SkinsensitiZatIOn(40,41)A,8,C,D,E,F,G,H,I,TGAI&EPC,J,K,L,M,N,OInitialfoindicatecertificafionastoinformationonthispageQjuDafe8(0(05(fulltextofcertificationisonpageone).-1ItfiJM'Z.bIZiJ/J'7t:LHJ..JICifLPage1of4UnitedStatesEnvironmentalProtectionOMBApprova12070-0t07AgencyWashington,D.C.20460OMBApproval2070-0057REQUIREMENTSSTATUSANDREGISTRANT'SRESPONSEINSTRUCTIONS;Pleasetypeorprintinink.Pleasereadcaretullytheattachedinstructionsandsupplytheintormationrequestedonthisform.Useadditionalsheet(s)itnecessary.1.CompanyNameandAddress2.Case#andName3.DateandTypeofDCIandNumberARYSTAlIFESCIENCENORTHAMERICACORPORI4092Thidiazuron08-May-200815401WESTONPARKWAY,SUITE150PRODUCTSPECIFICCARY,NC27513ID#PDCI-120301-26085EPAReg.No.66330-3244.Guideline5.StudyTillep6.Use7.Test8.Time9.RegistrantRProgressRequirement0ReportsPatternSubstanceFrameResponseNumberT(Months)0C0L123.ProductChemlA.ulr••••e..onUo",'emial.. 8630.t550vProductldenlityandcomposition(I)A,S,C,D,E,F,G,H,I,TGAI/MP/EProJ,K,l,M,N,O830.1600VDesCription01materialsusedtoptoducetheproduct(2)A,SfC,D,'E,F,G,H,I,TGAI/MP/EPG,".L,t,l.N.O'.830.t620vDescriptionofproductionprocess(3)A,S,C,D,E,F,G,H,I,TGA'8CoJ,K,L,M,N,0'8'30.t650Descriptionofformulationprocess(4)A,B,b,Cf,E,F,G,H,I,MP/EPJ,Kil,M,N,p830.1670,Discussionofformationofimpurities(s)A,B,C,D,E,F,G,H,I,J,K,l,M,N,0TGAJlMP/EP("830.1700,Preliminaryanalysis(6,7,8)A,B,C,D,E,F,G,H,I,TGAIe"J,K"L,M,N(0!'....830.t750VCertifiedlimits(9,to)A,S,C,D,E,F,G,H,I,TGAI/MP/EP8(p".K.L.M.N.0830.1800vE"n'rorcementanalytlciil'meihod(11)..A,S,C,D,E,.F','G,H,'I,TGAIiMPiEP...U:,".K,L.M.N.O.'830.E.'302.:·Y.Color(t9)A,S,C,D,E,F,G,H,I,TGAIIMP/EPCoJ,K,L,M,N,0'830.6:C3-\/'::''Physicalstate(22)'.'A,B.C,D,E;i=;G,H,1,TGAliMp/E'P-4>-..".'J/.K,L"M'-N,0 ' '..,",..€.30.6304Odor(23)A,S,C,D,E,F,G,H,I,TGAJlMP/EP8Ii;•·-J,K,L,M,N,0·..· .....,,{o.Ceriili<:aticn,'ICef<l:irythatthestatementsmadeonthisformandallattachmentsaretrue,accurate,andcomplete.Iacknowledgethatanyft.Dateknowinglyfalseormis1e.a'dingstatementmaybepunishablebylaw818/08SignatureandTitleofCompany'sAuthorizedRepresentative:Q)00u!dvf,,\t2.NameofCompany(::)''''''o\c.L,'1@S:,';"1\\nJ+iAAflAP(irnU.rv13.PhoneNumbet'I/JI-V:;!·5/1B

### Arysta LifeScience

August 8, 2008

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
One Potomac Yard, Room 8-4900
2777 South Crystal Drive Arlington, VA 22202



### Subject: Product Specific Data Call-In

- Thidiazuron 90-Day Response

Dear Ms. Briscoe,

Please find enclosed our 90-Day Response for the Product Specific Data Call-In for products containing Thidiazuron dated 

### May 8, 2008. The following documents are enclosed for 

### the products specified below.



### • Data Call-In Response Fonn

• Requirements Status and registranCs Response Form for

o Thidiazuron Technical, EPA Reg. No. 66330-324

o Thidiazuron-Diuron EC, EPA Reg

.. No. 66330-333

o Thidiazuron 4SC, EPA Reg. No. 66330-334

o Thidiazuron-Diuron SC, EPA Reg. No. 66330-344

o Thidiazuron-Diuron 4.5SC, EPA Reg. No. 66330-364

Arysta LifeScience has elected to voluntarily cancel Thidiazuron SOW, EPA Reg. No.
66330-323.

Should you have any questions in regards to tills submission, please 

## go not hesitate to

contact me at 901-432-5118 or bye-mail atbill.washburn@arystalifescience.com.

Sincerely,



## Bill Washburn Regulatory Manager**.~** ."1 , ' 

# .**~** ..

# F?~;;f~ 

# ,

.ry;{I"c**l/~lr.** 1 )LJ i ")

, Arysta LlfeScience North America Corporation / // .: "

15401 Wes10n Parkway, Sui1e t50, Cary, NC USA 27513 Telephone: (+ 1) 9t9-678-4900 Fax: {+ 1} 919-678-2194 www.aryslalifescience.com " >



### , ,

, 

### ,

### thidiazuron 8 month response Barbara Briscoe to: bill.washburn

Hi Mr. Washburn 02/03/200903:24 PM



### I received your 8 month response to the thidiazuron poel and have run into problem with the MRIDs for product chemistry 46736602 (our Information Services Office was unable to iden.tify the number) and the Skin sensitization study 46720308 is not in the system. Would you mind checking your files to see if these

are good numbers? Please back to me at your earliest convenience.

Thanks

Barbara Briscoe.w.J:A5.C..C.!<CI•r;""UC"UnitedStatesEnvironmentalProtectionAgencyWashington,D.C.20460DATACALL-INRESPONSE7(Jefr/if/DrOMBApproV312070-0107OMBApptQva12070"'()057INSTRUCTIONS;Pleasetypeorprintinink.Pleasereadcarefullytheattachedinstructionsandsupplytheinformationrequestedonthisform.Useadditionalshee\(s)ifnecessary.1.CompanyNameandAddress2.Case#andName3.DateandType01DCIandNumberARYSTALlFESCIENCENORTHAMERICACORPOR4092Thidiazuron08·May-200815401WESTONPARKWAY,SUITE150Chemical#andName120301PRODUCTSPECIFICCARY,NC27513ThidiazuronID#PDCI-120301·260854.EPA5.Iwishto6.GenericData7.ProductSpeciticDataProductcancelthisRegistrationproductregis-6a,IamclaimingaGenericab.IagreetosatisfyGeneric7a.MyproductisanMUPand7b.MyproductisanEUPandtratfonvolun-DataExemptionbecauseIDatarequirementsasindicatedIagreetosatisfytheMUPIagreetosatisfytheEUPtarilyobtaintheactiveingredientontheattachedformentitledrequirementsontheattachedrequirementsontheattachedfromthesourceEPAregis·"RequirementsStatusandformentitled'Requirementsformentitled"Requirementstrationnumberlistedbelow.Registrant'sResponse."StatusandRegistrant'sStatusandRegistrant'sResponse.'Response:66330-323:;.'XN.A.NA66330·324NAN.A.)(66330-333t {N.A.NAx.66330-334',(NA.NA.X66330·344-N.A.N:A.)Ii66330-364N.A.NAXC.:.:.cc:!!CertlhcatlooIcenify:ihatthestatementsmadeonthiSformandallattachmentsaretrue,accurate,andcomplete.Iacknowledgethatany•mlslegplngstatementmaybepunishablebyfine,Imprisonmentorbothunderapplicablelaw.9.DateSignatureandTitleofCompany'sAuthorizedWCl.."'Jl&uv-I·Aesotc1lXyMCf\csece/Blo8to.NameofCompanyRn.;S1cufcSc.'C',,",ceN.CJAVIAmefiCQLLQ11.PhoneNumbertJOf43Z:,//f3iii,IIiiiPI£;3se ((lad inSlructions on**rever~e** beforE' comp I!tlll.g ""Tn. F A**,~** d ""'18 2070-0060 

# ee rove

. NO. 

# 0 Reg'.:Jlration opp Identifier Number



# .. EPA United States 

# .." Environmental Protection Agency 

# 0 Amendment Washington, DC 20460 

# !19 Other
Application for Pesticide

- Section J

1. Company/Product Number 2. EPA Product Manager 3. Proposed Classification 

### EPA Reg. No. 66330-324 Joanne Miller

4. CompanyfProduct (Name) PM" 

# 0" None 

# o Restricted 

### Thidiazuron Technical 23

5. Name and Address of Application (Include ZIP Code) 6. Expedited Review. In accordance with FIFRA Section 3(c)(3) 

### Arysta LifeScience North America, LLC (b}(i), my product is similar or identical in composition and labeling 

### 15401 Weston Parkway, Suite 150 to: 

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

# o Check if/his is a new address Product Name



### Section" II 

# D Amendment

- Explain betow. 

# 0 Final printed tabels in response to

## ~ResubmiSSion in response to Agency letter dated _9/1/09_ Agency leiter dated 

# 0 D Notification

- Explain below. "Me Too" Application. 

# 0 Other

- Exptain below.

Explanation: Use additional page(s) if necessary. (For Section I and Section 11.)



### Submission of data in response to Agency Jetter dated September 1, 2009

Section**~** 

### III

1. Material This Product Will Be Packaged tn:

Child-Resistant Packaging Unit Packaging Water Soluble Packaging 2. TC:===tntainer 

# 0 y" 

# 0 y" 

# o y" Metal 

## I I Plastic 

# 0 No 

# 0 No 

# 0 No 

## I I Glass 

## I I Paper**~** Certfficatron must be If "Yes", Unit No. per If "Yes" No. per 

## I I Other (Specify) submftted Packaging wgt. container Package wgt container 

# I I

3. Location of Net Contents Information

. Size(s) Retail Container 5. Location of Labet Directions 

# o L,bel 

# D Container 

## I I On Label 

## I I On Labeling accompan ing product

6. Manner in Which Label is Affixed to Product 

## I I Lilhograph 

# 0 Other 

## I I Paper glued 

## I I SlencHed 

### Section**~** 

### IV

1. Contact Point Complele ITems directly below for identification of individual to be conlacfed, if necessa

, to process this a lication.)

Name Title Telephone No. (Include Area Code)



### Bill Washburn Regulatory Manager

### Phone:,(~pn**~32"51,1~:** 

## : '



# .. , Certification 6. bate**Ap~I:J;alio~** I certify thallhe Slalements I have made on this torm and all attachmenls Ihereto are true, accurate and complete. ' 'Receive<] ',,' I acknowledge Ihal any know'lngytalse or m'lsleading slalement may be punishable by fine or 'Imprisonment or



### . (stal)lpecj) both under applicable law. 

### "'"



### , " 2. Signature 3. Title ,

## ~w-=~ Regulatory Manager , '"

, 4. Typed Name 5. Date**~** , ) 

# . Bill Washburn September 16, 2009 

### "

Ee 

## ,m' 

# ,.

A Fo 57 1 {Rev. 8 .94 Previou ii sedton s are ob 

# " soe e, 

## W"'

. 

# " te EPA Ftte Copy (ongl at) 

### y, ' 

### '.' Ilow Applicant Copy

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



### Bill Washburn
530 Oak Court Drive
Suite 100 Memphis, Tenn. 38117

Dear Mr. Washburn:



### SUBJECT: Revised Basic Confidential Statement of Formula (CSF)
and Alternate Confidential Statement of Formula
Label Amendment
Thidiazuron Technical
EPA Registration No. 66330-324 

### Your Application Dated June 29, 2007 OFFICE OF PREVENTION. PESTICIDES AND TOXIC SUBSTANCES



## NOV 2 0 2007

The Agency has completed its reviews of the revised basic and alternate CSFs dated June 

### 29,2007 for the 

### above named product. The revised basic CSF and the proposed alternate
formulation are acceptable. The revised CSF for basic formulation will supersede the current CSF for basic formulation (dated 1116/02). 

### The data submitted for the guidelines 830.1700 (preliminary analysis) and 830.1800 (enforcement analytical method) are acceptable and support the proposed CSF for alternate fonnulation.

The label amendment referred to above, submitted in accordance wi th registration under
the Federal Insecticide, Fungicide, and Rodenticide Act, as amended, is acceptable with the following provisions:

I. Revise the "Environmental Hazards" statement to read as follows: "Do not discharge
effluent containing this product into lakes, streams, ponds, estuaries, oceans, or other waters unless in accordance with the requirements of a National Pollution Discharge Elimination system (NPDES) pennit and the pennitting authority has been notified in writing prior to discharge. Do

not discharge effluent containing this product to sewer systems without previously notifying the
local sewage treatment plant authority. For guidance contact your State Water Board or Regional Office of the EPA."

### A stamped copy is enclosed for your records. Please submit one (1) copy of your final printed labeling before you release the product for shipment. This amended labeling supersedes all previously accepted labels.

Enclosure athryn V. Montague Acting Product Manager (23)
Herbicide Branch Registration Division (7505C)

### DP BARCODE No.: 0341693 REG. No.: 66330·324 PRODUCT NAME: Thidiazuron Technical

DATE: 22/ OCT /2007

SUBJECT:

FROM:

TO: FEE.PRODUCT CHEMISTRY REVIEW OF TGAIIMP 

### [Xl EP 

### [l DP BARCODE No.: 

### 0341693 REG. No.: 

### 66330-324 PRODUCT NAME: Thidiazuron Technical COMPANY: Arysta Lifescience North America Corporation (ALSNA) PCC: 120301; Decision No.: 380908; ACTION CODE: R34 FOOD USE 

### [Xl INTEGRATED FORMULATION: Yes 

## [Xl No 

## [l

Shyam B. Mathur, Product Chem istry Team Leader Technical Review Branch/RD (7505P)

Tracy White 

### I Joanne Miller, RM 23 Herbicide Branch 

### I RD (7505P)

INTRODUCTION

The registrant ALSNA has submitted an application to amend the registration of Thidiazuron Technical reflecting the addition of al1ernate manufacturing locmion in for the thidiazuron TGAI/MUP. The registrant has submitted a proposed alternate CSF (dated**06~27-07)** 

### to represent the proposed alternate production site in The registram has also submitted a revised basic CSF (dated 06-29-07) which indicated the in as the production site. In support of the CSF for altemat ted 830.1700 (preJ'lm'lnary analysis) data under MRID No. 471708-01. The reviewer contacted the registrant (Mr. Bill Washburn) regarding the toxic characteristic of one new impurity reported in the alternate formulation. After consulting the toxicologist of the company, Mr. Washburn send bye-mail (dated 10-18-07, a copy of which is attached with his report), 1he toxicological evaluation of the new impurity which suggested1hat the impurity in question is not toxicological significance. TRB has been asked to determine whether the data submitted corresponding to guideline 830.1700 (five batch analysis) supports 1he proposed alternate CSF (dated 06-29-07) and de1ermine their acceptability.

SUMMARY OF FINDINGS

1. The nominal concentration & the product label claim of the active ingrediem thidiazoron technical is 98.3% in the basic formulation (dated 06-29·07). In the alternate formulation the NC of the AI is 98.3%. The alternate formulation CSF (dated**06~29~07)** 

### is supported by the five batch analysis.

2. The impurity profiles for the revised basiC CSF (dated**06~29-07)** 

### & the proposed alternate CSF (dated 06·29-07) are very much comparable. There are impurities listed on proposed CSF for alternate formulation (dated**06~29-07)** 

### and the revised basic CSF (dated 06-29·07). of these impurities are

common between the CSF's, where as there is one new impurity listed in the proposed alternate CSF at the concentrations of The proposed alternate CSF is substantially similar to the revised basiC CSF (dated**06~29-07)** 

### with respect to physical-chemical properties. The al1emate formulation is in compliance with PR Notice 91-2 and 40CFR§152,43.

3. TRB has no knowledge about the toxic properties of the new impurity listed in the proposed CSF for alternate formulation. For the name of the impurity, please refer to Confidential Appendix. According to the report of1he company (e-mail dated**10-18~07),** 

### the new impurity is not of toxicological significance.

# THIDIAZURON TECHNICAL

For Cotton Defoliant Formulation Use Only

ACTIVE INGREDIENT: Thidiazuron",

. . . . . . .................................................... 98.30%
INERT INGREDIENTS:

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

.. .. . . . . . . . .. 1.70% TOTAL:

........................................................ 100.00%

"N-phenyJ-N-I,2,3-thiadiazol-5-yl urea

IF INHALED: 

## •

•



# • IFON SKIN OR 

## • CLOTHING: 

## •


# • IF IN EYES: 

# •
•

• IF SWALLOWED: 

# •

•


# •

• KEEP OUT OF REACH OF CHILDREN

CAUTION

FIRST AID
Move person to fresh air.
If 

### person is not breathing, call 911 or an ambulance, then give artifjcial respiration, preferably mouth-ta-mouth, jf possible. 

### Call a poison control center or doctor for further treatment advice.
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.
Hold eye open and rinse slowly and gently with water for 1 ()"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.
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 do so by the poison control center or doctor.
Do not give anything by mouth to an unconscious person.

HOT LINE NUMBER

Have the product container or label with you when calling a poison control center or doctor, or going for
treatment. FOR 24- HOUR EMERGENY MEDICAL ASSISTANCE CALL: 1-866-303-6952 FOR CHEMICAL EMERGENCY: Spill, leak, fire, exposure, or accident call CHEMTREC 1-800-42<f-.9300

EPA Reg. No. 66330-324 Manufactured For:
EPA Est. No. 

## xxxx-xxx-AtlCEPTED ARYSTA LlFESCIENCE NORTH AMERICA CORPORATION
AD XXXXXX 

## with COMMENTS

, t5,d,0,1 Weston Parkway, Suite 

### 150

NET CONTENTS:**ln~PALe!JerDa'.a:** ,.:. Cary, NC27513**~jOV** 

### L 

## U ;(1")"' ' ":



### 'lnderthe Fedaa1**~uc** ';ungicidt.. aru1**~i!c<dla..:** Ar.:

'i; mnendea,.:all**~!lt'** "l'f;ld;!C;**'!~irrro!'lW:tffiikdBi'''', h~;~**  :i>1{, 

### '"

,

Filename: THlDlAZURON TH'IINICAL (bbel}(66330-324}(062707)PRECAUTIONARY STATEMENTS

HAZARDS TO HUMANS AND DOMESTIC ANIMALS



### CAUTION. Harmful 

### if swallowed, inhaled, or absorbed through the skin. Avoid breathing dust. Avoid
contact with skin, eyes, and clothing. Do not contaminate food or feedstuffs.

ENVIRONMENTAL HAZARDS

Do not d'ischarge effluent containing this product into lakes, streams, ponds, estuaries, oceans, or public
waters unless this product is specificalJy identified and addressed in an NPDES permit. Do not discharge effluent containing this product to sewer systems without previously notifying the sewage treatment plant authority. For guidance, contact your State Water Board or Regional Office of the EPA.

DIRECTIONS FOR USE



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

Labeling for products formulated from this product must conform to that which is currently registered with
the U.S. Environmental Protection Agency.

Only for formulation into a defoliant, for the following uses:

1. Terrestrial Food Crop: Cotton.

2. Uses for which U.S. EPA has accepted the required data and/or citations of data that the formulator has submitted in support of registration.

3. Uses for experimental purposes that are in compliance with U.S. EPA requirements.

STORAGE AND DISPOSAL

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

STORAGE: Store product in original container only, away from other pesticides, fertilizer, food or feed.

PESTICIDE DISPOSAL: Do not contaminate water, food or feed by storage or disposal. Wastes resulting from the use of this product may be disposed of on site or at an approved waste disposal facility.

CONTAINER DISPOSAL: Completely empty liner by shaking and tapping sides and bottom to loosen clinging particles. Empty residue into manufacturing equipment. Then dispose of liner in a sanitary landfill

or by incineration if allowed by state and local authorities. If drum is contaminated and cannot be reused, dispose of in the same manner.

DO NOT REUSE EMPTY CONTAINER

., 

### "

FI:C"<1illC: TI-JJDJAZURON TECI-INICAL (labcl)(G633D ·324)(062707) 

### , "

,

') I ,,'
)

"
,



### 2WARRANTY AND DISCLAIMER STATEMENT



### 1. Arysta walTanls that Ihis product conforms to the chemical description on the label and is reasonably fit for the purposes stated in the Directions for Use, subjecl to the inherent risks described above, when used in accordance with the Directions for Use under normal conditions. 2. 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. 3. 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.**~** , 

### , , .,'

, " 

### , "



# . '"

,

Pi ICllamc; THtDIAZU RON rEel-IN tCA, L (lnbcl)( 66330·324)(062707) 3DP BARCODE 

### No.: D341693 REG. 

### No.: 66330-324 PRODUCT NAME: 

### Thidiazuron Technical

4. The data submitted corresponding to guideline 830.1700 (prenminary analysis) satisfy the data requirements of 40CFA§158.170. The validated HPLC-UV method was used for the identification and quantificatiOn of the active ingredient content and the impurities. The content of thidiazuron was measured HPLC-UV (290 nm) with external standard quantitative method. The analytical method employed a Zorbax SB-AQ, 250 x 4.6 mm, 5 J,Jm, reversed phase column. The impurities were also determined by HPLC-UV (280 nm) with external standard method, for residual organic solvent impurity the UV detector was operating at 205 nm. The methods were validated for precision, linearity, and
accuracy. For details please refer to confidential appendix [MRID No. 471708-01].

5. The data submitted corresponding to guidelines 830.1800 (enforcement analytical method) satisfy the data requirements of 40CFR§158.180. The analytical method described in item #4 was also used as enforcement analytical method.



### gONCLUSION$

TAB has evaluated the revised basic CSF, the proposed alternate CSF and the supporting product chemistry data and has determined that:

1. The data submHted for the guidelines 830.1700 (prel'lminary analysis) and 830.1800 (enforcement analytical method) are acceptable and support the proposed CSF for alternate formulation (dated 06-29- 

### 07).

2. The revised CSF for basic formulation & the proposed CSF for alternate form ulation (both dated 06-29- 07) are acceptable. The revised CSF for basic formulation (06-29-07) will supersede the current CSF for basic formulation (dated 01-16-02).

3. According to the toxicological evaluation report from the company, the new impurity reported in the alternate formulation is not of toxicological concern at the level present in the formulation. Based on this evaluation and explanation provided by the registrant, TAB trusts the scientific judgment of the company & believes that the presence of this impurity in the 1hidiazuron TGAIIMUP will not have any adverse health & environmental effects.

2"Washburn, Bill" <BiII.Washbum@arystalifesci

ence.com>

10/18/200706:31 PM

Dear Dr. Mathur: To Shyam MathurIDC/USEPNUS@EPA



### cc

bee

Subject Thidiazuron Technical, 66330-324

The impurity identified as n the Alternate Confidential Statement of
Formula dated June 29, 2007 is not of toxicological significance.

As evidence, I offer the discussion offered by Ms. Beth Mileson and the two of the documents that supports her argument.

Should you find that additional information is needed in support of this formulation, please do not hesitate
to give me a call.

Regards,



### Bill Wailibum Regulatory Manager

Alysia LifeScience North America Corporation 

### 530 Oak Court Drive, Suite IOO 

### Memphi,. TN 38117 Tel 901-432-5118
I"ax 901-432-5031**m;~,** ,.,", '.**%~'"'** ThicfiaZUlon Impwity Statement {8. Mileson 101807).doc

### Evaluation of the impurity,

, in thidiazuron Beth E. Mileson, Ph.D., DABT 

## 10/18/2007

The impurity identified in the alternate source of thidiazuron is not expected to be toxicologically significant. The impurity identified at is a known analogue of thidiazuron, and the biological activity of this compound has been characterized and reported in the literature.

In assays of plant physiology, exhibited the same biological activity as thidiazuron Thidiazuron acts as a cotton defoliant by stimulating ethylene production in the plant which causes the leaves to mature and drop off (EPA, 2004). The impurity, stimulates ethylene production in plants by the same mechanism as thidiazuron, but at a lower potency

The mammalian toxicity of thidiazuron has been characterized by EPA (EPA, 2005). The striking similarity in structure between and thidiazuron suggests that the compounds share similar toxicity. The similarity in biological activity of the two compounds in plants described in the previous paragraph supports this perspective.

The presence of the impurity in the alternate

source of thidiazuron is not of toxicological significance because: 1) the structural similarity of thidiazuron and the impurity suggests the compounds share similar toxicity, 2) shares the same mechanisms of biological activity with thidiazuron, and 3) the impurity is present at a low level.

References Evans, W. Environmental Fate and Effects Division Risk Assessment for the Reregistration Eligibility Decision of Thidiazuron for Use on Cotton, EPA OPPTS SRRD. PC Code: 120301. December 2004

Jimerson, T. Thidiazuron: Revised HED Chapter of the Reregistration Eligibility Decision Document (RED). PC Code: 120301, Case 

## #: 4092, DP Barcode: D314679. 

## 51212005.Dr. Mathur: ftWashburn, Bill" <Bill. Washbum@arystalifesci

ence.com>

10/16/2007 

### 04:28 PM To Shyam Malhur/DC/USEPAlUS@EPA



### cc

bee

Subject Thidiazuron Technical, Alternate Formulation

I have been informed that our toxicologist is out of the office. I have a call in to him but have not heard from him today. I will do my best to get you an answer in regards to the impurity by tomorrow.

Thanks,



### Bill Washburn Regulatory Manager



### Arysta LifcScience North America Corporation
530 Oak Court Drive, Suite 100 Memphi" TN 38117 Tel 901-432-5118
Fax 901-432-5031DP BARCODE No.: 0341693 REG. No.: 66330-324 PRODUCT NAME: Tbidiazuron Technical

830.1550. Product Identity 

### & composition:

CAS ___

### .::es~~.m: 

# I**Thldlazur~~_~~1** .......
ACllve Ingredienl. 

## i Thidiazuron



### -- ... -----_._. __ .,........!-_

.. -,

.. _ .. - -_._-**------.-~-** 

### ... ClassifIcation: 

## i Plant growlh regulator



# .... -._-c.---

___ ._- ...**E~~i~iCa!_:.orm_~I.~:_.-i _?~~~~~_?~**  

# ____ .. ___ .. ,. Moieclilar Weigh!: 

# I 220_2



## --**·---1--···--~-·--·** RegIster Number' 151707·55-2 .j.



### i IUPAC Name' 

### i I·Phenyl-3-(1.2,3-lhiadjazol-5-yIJurea 

# _.+

Siructure Formula: 

# 10

1

# ~ ,-\,**I~ ,~~** 

. N N H H

3

### Pages 62-66 *Confidential Statement of Formula may be entitled to confidential treatment* *Manufacturing process information may be entitled to confidential treatment*

### DP BARCODE No.: 034 t693 REG. No.: 66330-324 PRODUCT NAME: Thidiazuron Technical

CONFIDENTIAL APPENDIX



### The registrant submitted the following report On the toxic characteristics of the new impurity present in the

alternate formulation:

·Washburn, Bill" <811J,Waahbum@aryst8llfesci
once.com>


### I01t8l.2oo706:31 PM



### Dear Or. Mathur: To Shyem 

### Matl'lur/DCIUSEPAlUS@EPA

hoc 

### Subject Thidlazuron Technical, 66330-324



### The impur'lty 

### identified as 

### In the Altemate Confidential Statement of Formula dated Juno 29, 

### 2007 is not of toxicological significance.

As evidence, I offer the discussion offered by Ms. 

### Beth MHeson 

### and tho 

### two of the 

### documents that supports her argument

Should you tind that additiOnal informalion is needed in support ot this formulation, please do not hesitate to 

### giVe me a calL

Regards,

Bill Wuhbwu 

### Regulatoty M..,...,

AIysta 

### l.ifeScience North 

### America Corporation
530 Oak Cowt Drive. Suite I ()(l Memphis. 'fN 38J17 Tel901wl32-51 J8 

### :Fax 901-432-5031 

# "!; i!l"

. 

# "!;**Thi<Mzuron!~** 

### StaletrlOnllB. Mieton IOtOO7].doc::

9DP BARCODE No.: 0341693 REG. No.: 66330-324 PRODUCT NAME: Thidiazuron Technical

CONFIDENTIAL APPENDIX

Evaluation 

### of the Impurity, In thldlazuron Beth E. Mlleson, Ph.D., DABT 

### 1011812007

The Impurity identified in the alternate source of thidiazuron is not expecfed to 

### be toxicologically significant. The impurity Identified af is 

## a known analogue of thldiazuron, and the biOlogical activity of this compound has been characterized and reported in the literature.

In assays of plant physiology, exhibited the same biological activity as thidJazuron

, Thidlazuron acts as 

### a coHon defolJant 

### by stimulating ethylene production in the plant whIch causes the leaves to mature and drop off (EPA, 2004). The impurity, stimulates ethylene production in plants by the same mechanism as thidiazuron, but at 

## a lower potency

The mammalian toxicity of thldlazuron has been characterized by EPA (EPA, 2005). The striking similarity in structure between and thidiazuron suggests that the compounds share similar toxicity. The similarity in biological activity of the two compounds in plants described in the previous paragraph supports this perspective.

The presence of the 1 impurity in the alternate

source of thidiazuron is not of toxicological significance because: 1} the structural Similarity of thidiazuron and 

### the impurity suggests the compoundS share similar toxicity, 2) shares the same mechanisms of biological activity with thidiazuron, and 3) the impurity Is present at 

## a low level.

References Evans, W. Environmental Fale and Effects Division Risk Assessment for the Reregistration Eligibility Decision of Thidiazuron for Use on CoHon, EPA OPPTS SRRD. PC COde: 120301. December 2004

Jimerson, T. Thidiazuron: Revised HED Chapter of the Reregistration Eligibility Decision Document (RED). PC Code: 120301, Case 

### #: 4092, DP Barcode: 0314679. 5/212005.



### 10

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



### July 10, 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 02-1UL-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 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.

# e

Arysta LifeScience

REGISTRATION ACTION: Non-Fast Track Amendment to Registration of Manufacturing-Use Product

FEE CATEGORY: R34 REGISTRATION FEE: $3,150

VIA FEDEX DELIVERY (Tracking No. XXX)( XXX)( 

### XXXX)

Ms. Joanne Miller Product Manager 23 Document Processing Desk (REGFEE) Office of Pesticide Programs (7504P) U.S. Environmental Protection Agency Room S-4900, One Potomac Yard 2777 South Crystal Drive Arlington, VA 22202-4501

Dear Ms. Miller:

Subject: Thidiazuron Technical 

### June 29, 2007

EPA Registration Number 66330-324
Active Ingredient: Thidiazuron 

### Application to Amend Registration to Add Alternate Manufacturing Location 471708_00



### Please find enclosed an application from Arysta LifeScience North America Corporation (ALSNA) to amend the subject registration ofThidiazuron Technical to add an altemate manufacturing location. The following enclosures and attachments are included in this registration amendment application:

1_ EPA Form 8570-1 

### (Application for Registration Amendment)

One copy of EPA Form 8570-1 

### (Application for Registration Amendment) dated June 29, 2007 is enclosed. The application is to amend the registration of a manufacturing-use product to add an alternate manufacturing location. ALSNA
proposes this as a PRIA registration fee Category R34 non-fast track amendment submission requiring a fee payment of $3, 150 as per 70 

### Federal Register 32327- 32335 (June 2, 2005).

Arysta UfeScience North America Corporation

15401 Weston Parkway, Suite 150, Cary, NC USA 275 13 Telephone: (+1) 919-678-4900 Fax: (+1) 919-678-2194 www.arystalifescience.comPage 2 of 3



### 2. EPA Forms 8570·4 

### (Confidential Statement of 

### Formula)

One copy each of 

## two EPA Forms 8570-4 

### (Confidential Statement of 

### Formula) each dated June 29, 2007 are enclosed.

The first CSF form is being submitted as an updated version of 

### the "Basic Formulation" (Box A) and it is applicable to the original manufacturing facility identified in Box 2. This revised CSF is a replacement for the last CSF for the basic formulation dated January 16, 2002 and submitted to the EPA on February 1, 2002. The correct registrant name, address and EPA registration number are



### now shown in Boxes 1 and 4, respectively. Other minor revisions in this basic CSF are described in a CBI attachment to this letter.

The second CSF is being submitted as an "Alternate Formulation" (Box A) applicable to the alternate manufacturing facility identified in Box 2. Additional information pertaining to this CSF is described in the CBI attachment to this letter.

3. Revised Label for Thidiazuron Technical

Five copies of a revised label for Thidiazuron Technical are enclosed. This label incorporates the text reviSions specified by the EPA in the last Notice of Pesticide Registration Certificate (EPA Form 8570-6) issued for this product on January 10,2003. In addition, the correct registrant name, address and EPA registration 

### number are included on the revised label. As this application is an amendment
to an existing registration to add an alternate manufacturing location, the concentration of the active ingredient shown in the label ingredient statement has not been changed.



## 4. 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. A study containing the analysis results for the concentrations of active ingredient and impurities in 5 pilot plant batches of thidiazuron from the alternate manufacturing facility is being submitted in support of this application.Page 3 of 3



### 5. Study Reports

Three bound and labeled copies of the 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 processing of this amendment.

Very truly yours,

BiliWashbum Regulatory Manager

Phone: (901) 432-5118 E-Mail: bill.washburn@arystalifescience.comPlease read in5truclkmson reverse before completir, Form APprove' > o. 2070·0060

" OPP Identifier Number

### ~ 

# EPA United States 

# D Registration 

# '"' Environmental Protection Agency 

# 0" Amendment Washington, DC 20460 

# D Other



### 3'S7 Application for Pesticide· Section I

1. Company/Producl Number 2. EPA Product Manager 3. Proposed Classilication 

### EPA Reg. No. 66330-324 

### Joanne Miller



# ,. Company/Product (Name) PM' 

# 0" None 

# o Restricted 

### Thidiazuron Technical 23

5. Name and Address of Application (Include ZIP Code) 6. Expedited Review. In accO/dance with FIFRA Section 3{c)(3) 

### Arysta LifeScience North America (b)(i), my product is similar 01 identical in composition and labeling 

### Corporation to:



### 15401 Weston Parkway, Suite 150 EPA Reg. No.


### Cary, North Carolina 27513 

# o Check If this i5a newaddross Product Name



### Section -II 

# 0' Amendment

- Explain below. 

# o Final printed labels in response to 

# D Agency leiter dated Resubmission in response to Agency leller dated 

# o "Me Too" Application. 

# D Notification· Explain below. 

# o Olher· Explain below.

Explanation: Use addilional page(s) if necessal)'. (For Seclion I and Seclion 11.) 

### This is a non-fast track application to amend the registration of a manufacturing-use product to add

an alternate manufacturing location. As per 70 Federal Register 

### 32327- 32335 (June 2, 2005), this is

a PRIA registration fee Category: R34 submission (Table 5) requiring a fee payment of**~31150.**



### Section

- III

i. Material This Product Will Be Packaged In:

Child·Resistant Packaging Unit Packaging Water Soluble Packaging 2. ype of jOnlainer 

# D Yo. 

# D Yo. 

# D Yo. Metal 

## I I Plastic 

# D No 

# D No 

# D No 

## I I Glass 

## I I Paper * Certfflcat{on must be If "Yes", Unit No. per If ''Yes'' No. per 

## I I Olher (SpeCify) submitted Packaging wgt. container Package wgt container 

# I I

3. Localion of Net Contenls Information Size(s) Retail Conlainer 5. Location of Label Directions 

# o Label 

# o Container 

## I I On Label 

## I I On Labelino accompanying product

6. Manner in Which Label is Affixed 10 Product 

## I 

## I Lithograph 

# D Othel 

## I 

## I Paper glued 

## I I Stenciled 

### Section -IV

1. Contact Poinl (Com fete ilems dfrecl/ below for idenlificalfon of indivfduallo be confacled, if necessa ,fo rocess this a licalion.)

Name Title Telephone No. (Include Area Code)



### Bill 

### Washburn Regulatory Manager Phone: 

### (901) 432-511t1 E-mail:
bill.wasr.burn((i;arvslalifescience.com

Certiticatlon



### , 

# ' nate Application I certilythat the statements I have made on this lorm and all attachments thereto are true, accurate and complete. 

## , r<eceived
I acknowledge that any knowingly false or misleading statement may be pUnishable by fine or imprisonment or 

# I (StaottJ ed ) both under applicable law_
2.**Signal~~** , 3. Title 

# ,



# .**"-'W~~** Regulatory Manager 

## , 

# '" Typed Name 5. Dale 

### Bill Washburn June 29, 2007

EP A Form 8570 1 lRev. 8 94) Pre\llOus edlbons are obSOlete. " " White EPA FIle Copy longlnat) " Yellow

.... pphcant CopyArystaLifeScienceNorthAmericaCorporation15401WestonParkway,Suite150Cary,NorthCarolina27513ProductName:EPARegistrationNumber:BIBLIOGRAPHYOFSUBMITTEDSTUDIESThidiazuronTechnical66330-324PurposeofSubmission:DateofSubmission:ApplicationtoAmendRegistrationtoAddAlternateManufacturingLocationJune29,20071of1ofThidiaz:J:,o.1TGAII-Validalior.ofAnalyticalMethodologyfortheAssayofAc!iveIn£rgdientandRelatedSignificantImpuritiesofThidiazL.;jonTGAIandSubsequent5-BatchAnalysisofTGAINC-2007-006OPPTS830.1700830.1800GroupAProductChemistryPage1of147170801

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



### luly 

### 5,2007

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-380908
EPA File Symbol or Registration Number: 

### 66330-324 OFFICE OF PREVENTION, PESTICIDES AND TOXIC SUBSTANCES



### Product Name: ARYSTA LIFESCIENCE NORTH AMERICA CORPORATION
EPA Receipt Date: 02-lul-2007

EPA Company Number: 

### 66330 Company Name: ARYSTA LIFESCIENCE NORTH AMERICA CORPORATION

Mr. Bill Washburn
ARYSTA LIFESCIENCE NORTH AMERICA CORPORATION
15401 WESTON PARKWAY, SUITE 150 CARY, NC 27513-



### SUBJECT: Receipt of Amendment Subject to Registration Service Fee

Dear Registrant:

The Office of Pesticide Programs has received your application for Amendment. If you submitted data with this application, the results of the PRN-86-5 screen will be communicated separately. During the administrative screen, the Office of Pesticide Programs has 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: R34

NON-FAST-TRACK (INCLUDES CHANGES TO PRECAUTIONARY LABEL STATEMENTS;SOURCE CHANGES TO AN UNREGISTERED SOURCE);

Please remit payment in the amount of: $ 

### 3,150 to:

ByUSPS:

USEPA Washington Finance Center
Pesticide Registration Service Fee
PO Box 360277 Pittsburgh, PA 15251

### By Courier:
U.S. EPA Washington Finance Center Pesticide Registration Service Fee CIO 

### Mellon Client Service Center
500 Ross Street, Room 670
Box 360277 Pittsburgh, PA 15251-6277
Attn: EPA Module Supervisor Telephone: (412) 236-2294

All payments must be in United States currency by check, bank draft, or money order drawn

to the order of the Envirorunental 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 horne page, select
"search by fonn name." From the next page, select "P," then click on "Pesticide Registration Improvement Act. Fee Payment" and complete 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 soley
associated with an IR-4 tolerance petition. Please be advised that if you intend to request a waiver, you must do so in writing within 15 days ofreceipt of this invoice instead of remitting
the amount indicated above. OPP will not consider waiver requests after the registration service
fee has been paid. Infonnation 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/pesticides/fees.

Please send Registration Service Fee Waiver requests to:

By USPS: By Courier:
Document Processing Desk (WAIVER)
Office o[Pesticide Programs (7504P)
U.S. Environmental Protection Agency
Room S-4900 Potomac Yard Document Processing Desk (WAIVER)
Office o[Pesticide Programs (7504P)
U.S. Environmental Protection Agency
1200 Pennsylvania Ave NW Washington, DC 20460 2777 S. Crystal Dr. Arlington, VA

A PRIA decision time review period will not start until a fee waiver is granted and/or the Agency receives certification that the outstanding fee has been paid. If the Agency does not receive certification of payment for this action or a fee waiver request within the next 45 days,
the Agency will presume that you no longer want to pursue this action. The Agency will then
initiate a process that may result in administrative withdrawal of this action.

If you have any questions, please contact the Pesticide Registration Service Fee Ombudsman,

### at (703) 305-6249.



### Sincerely,

sing Staff
rmation echnology 

### & Resources Management Division

# IFee for Service\ 

# f{812857GThis package includes the following



# New Registration

. Amendment

" Studies? Fee Waiver? J for Division



# •• AD

BPPD

•• RD

vol pay 

# % Reduction:

__ "--- 

# Risk Mgr. 

# []TI

Receipt No. 

# s-I 812857

EPA File Symbol/Reg. No. 1 

# 66330-324

I 

# Pin-Punch Date: 

# I 7/2/2007

I 

# o This item is NOT subject to FFS action.

Action Code: I Parent/Child Decisions:

,

, 

# , , 

## ,

ILI

__________________ _**L,------------------~~** 

# Inert Cleared for Intended Use'! Uncleared Inert in Product

Reviewer:

# ((;~ 

# - Date: 

# 1- £-O.!z

Remarks: 

# CSrRegulatory Type: !Product Registration

- Section 3

### ~~ h:.o<' r'Y ; 

# r. ',lYe;j 

# 't,':

Application Type: jAmend;Jerrt

### ~~-----.~~--- .. C 

# 3 B1Uab!e; 

## r. Yes 

## r No

Comparv:

### ~6330 f,RYST A lIFESCIENCE NORTH AMERICA CORfC ":' 

# -Y,J

Risk Manager: J"Registration Division,

### Ri~~eme:rd: Team 23

### ,'~

Product #:

# 66330-~~~ Product Name: 

## FRYsTA lIFESCIEN:E

# ~O~T_tfAIY1E~lo:~:CO;'

Me Too Section3:

Application Date:

Front End Date:

FFS Due Date:

OPP Tatget Dille:

Fast Track: 

# r Receipt Description:

### "~Co"'"mO'=O=d~~C,C,C,OgCim='"'~liO=,C'=Of",CoC=m='oCu"1C'=ctCuC'iCngC_Cu=,,~pC'OCdCu"ctC----­ 

# ,**P~** e relid instru Ii n reverse bef r pfefr 

# '" canso o ecom 

# .. " Fa Approve 'flS NO 2070-0060**~** , 

# 0 Registration opp Identifier Number



# .. EPA United States 

# .." Environmental Protection Agency 

# 0 Amendment Washington, DC 20460 

# 0 Other


# a

S 7 Application for Pesticide w Section I

1. CompanylProduct Number 2. EPA Product Manager 3. Proposed Classification 

### EPA Reg. No. 66330-324 Joanne Miller

4. CompanylProduct (Name) PM> 

# 0" None D Restricted 

### Thidiazuron TeChnical 23

5. Name and Address of Applicalion (Include ZIP Code) 6. Expedited Review. In accordance with FIFRA Section 3{c)(3) 

### Arysta LifeScience North America (b)(i), my product is similar or identical in composilion and labeling 

### Corporation to; EPA Reg. No. 

### 15401 Weston Parkway, Suite 150 Cary, North Carolina 27513 Product Name 

# D Check if this is" new address


### Section -II 

# 0" Amendment

- Explain below. D Final printed labels in response to 

# 0 Agency letter dated Resubmission in response to Agency letler dated 

# o "Me TooH Application. 

# 0 Notification

- Explain below. 

# o Other

- Explain below.
Explanation: Use additional page(s) if necessary. (For Section I and Section 11.) 

### This is a non-fast track application to amend the registration of a manufacturingwuse product to add

an alternate manufacturing location. As per 70 

### Federal Register 32327

- 32335 (June 2, 2005), this is

a PRIA registration fee CategorY R34 submission (Table 5) requiring a fee payment of**~31150.**



### Section -III

1. Material This Producl Will Be Packaged In:

Child· Resistant Packaging Unit Packaging Water Soluble Packaging 2. ype of jOnlainer

DYes 

# o y" DYes Metal 

## I I Plastic 

# o No 

# o No 

# o No 

## I I Glass 

## I I Paper

• Cerlfffcation must be If "Yes", Unit No. per If ''Yes" No. per 

## I I Other (Specify) submitted Packaging wgt. container Package wgt container 

## I I

3. Location of Nel Contents Informalion

. Size{s) Retail Container 5. Localion of Label Directions

D Label D Container 

## I I On Label 

## I I On Labeling aCCompan ing ptoduct
6. Manner in Which label is Affixed to Producl 

## I I Lithograph D Other 

## I I Paper glued 

## I I Stenciled 

### Section -IV

1. Contact Point Com fete items direcflY....below for identificafion of individual 10 be contacled, if necessa ,/0 rocess this a licalion.)
Name Title Telephone No. (Include Atea Code)



### Bill 

### Washburn Regulatory Manager Phone: (901) 432-5i 'ill, :**E-mai!:~"':'** 

### "**bi!l.wasj-burn~aNsta!ifescience.com** Certification j ',' 1.' Date Application I certify that the statements I have made on this form and all attachments the/etc are true. accurate and complete. .; Keceived I acknowledge that any knowingly false or misleading statement may be punishable by fine or imprisonment or 

# I

.. (Stan)PedL both undEl/ applicable law. "

, '

2. 

# S;'OO''\CS<-Qj>**~ ~**  3. Title 

### " 

### ReQulatorv ManaQer 

### ' ,<:

4. Typed Name 5. Dale "

, 

### Bill Washburn June 29, 2007 '" ,


# . EPA F rm 8570-1 R v. _04 Previous r are ob I



# - ..



### - o ! e 8 ) edllons soete. White EPA File Copy (ollgmal) Yellow Afl'phcant Copy

# B

Arysta LifeScience

REGISTRATION ACTION: Non-Fast Track Amendment to Registration of Manufacturing-Use Product

FEE CATEGORY: R34 REGISTRATION FEE: $3,150

VIA FEDEXDELIVERY (Tracking No. XXXX XXXX XXXX)

Ms. Joanne Miller Product Manager 23 Document Processing Desk (REGFEE) Office of Pesticide Programs (7504P) U.S. Environmental Protection Agency Room S-4900, One Potomac Yard 2777 South Crystal Drive Arlington, VA 22202-4501

Dear Ms. Miller.

Subject: Thidiazuron Technical June 29, 2007

EPA Registration Number 66330-324 Active Ingredient: Thidiazuron Application to Amend Registration to Add Alternate Manufacturing Location

Please find enclosed an application from Arysta LifeScience North America Corporation (ALSNA) to amend the subject registration of Thidiazuron Technical to add an alternate manufacturing location. The following enclosures and attachments are included in this registration amendment application:

1. EPA Form 8570-1 

### (Application for Registration Amendment)

One copy of EPA Form 8570-1 

### (Application for Registration Amendment) dated June 29, 2007 is enclosed. The application is to amend the registration of a manufacturing-use product to add an alternate manufacturing location. ALSNA
proposes this as a PRIA registration fee Category R34 non-fast track amendment submission requiring a fee payment of $3,150 as per 70 

### Federal Register 32327- 32335 (June 2, 2005).

Arysta LifeScience North America Corporation

i 5401 Weston Parkway, Suite 150, Cary, NC Us,.c.. 27513 Telephone: (+ \) 919·678-4900 Fax: (+ 1) 919-678-2194 www.arystalilescience.comPage 2 of 3



### 2. 

## EPA Forms 8570-4 

## (Confidential Statement of Formula)

One copy each of two EPA Forms 8570-4 

### (Confidential Statement of 

### Formula) each dated June 29, 2007 are enclosed.

The first CSF form is being submitted as an updated version of the "Basic Formulation" (Box A) and it is applicable to the original manufacturing facility identified in Box 2. This revised CSF is a replacement for the last CSF for the basic formulation dated January 16, 2002 and submitted to the EPA on February 1, 2002. The correct registrant name, address and EPA registration number are

now shown in Boxes 1 and 4, respectively. Other minor revisions in this basic CSF are described in a CBI attachment to this letter.

The second CSF is being submitted as an "Alternate Formulation" (Box A) applicable to the alternate manufacturing facility identified in Box 2. Additional information pertaining to this CSF is described in the CBI attachment to this letter.

3. Revised Label for Thidiazuron Technical

Five copies of a revised label for Thidiazuron Technical are enclosed. This label incorporato:>s the text revisions specified by the EPA in the last Notice of Pesticide Registration Certificate (EPA Form 8570-6) issued for this product on January 10,2003. In addition, the correct registrant name, address and EPA registration number are included on the revised label. As this application is an amendment
to an existing registration 

## to add an alternate manufacturing location, the concentration of the active ingredient shown in the label ingredient statement has not been changed.

4. Bibliography 

## of Submitt!!d Studies

One copy of the Bibliography of Submitted Studies (transmittal document) describing the submitted data in support of this registration application is enclosed. A study containing the analysis results for the concentrations of active ingredient and impurities in 5 pilot plant batches of thidiazuron from the alternate manufacturing facility is being submitted in support of this application.Page 3 of3



## 5. Study Reports

Three bound and 

### labeled copies of the 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 processing of this amendment.

Very truly yours,

Bill Washburn Regulatory Manager

Phone: (901) 432-5118 E-Mail: bill.washburn@arvstalifescience.comArystaLifeScienceNorthAmericaCorporation15401WestonParkway,Suite150Cary,NorthCarolina27513ProductName:EPARegistrationNumber:BIBLIOGRAPHYOFSUBMITTEDSTUDIESThidiazuronTechnical66330-324PurposeofSubmission:ApplicationtoAmendRegistrationtoAddAlternateManufacturingLocationDateofSubmission:June29.20071of1ofThidiaz";mTGAII'-ValidaJor.ofAnalyticalMethodologyfortheAssayofAc!iveIn£r'3dientandRelatedSignificantImpuritiesofThidiazL.:;-onTGAIandSubsequentAnalysisofNC-2007-006OPPTS830.1700830.1800GroupAProductChemistryPage1of1PRFORM9-11(MARCtf2006)§rmn,1flV!InI'llL'\ ('3(]-jcJrREGISTRATioNNO.CONFIDENTIALSTATEMENTOFFORMULAENCLOSEDDATESUBMITTEDSUBMITTEDBY(./)APPLICANTBASICSUPPUERDoNotWriteComments,formula,orPartsofformulaonThisEnvelopeNOTEItshallbeunlawful-foranypersontouseforhisownadvantageortoreveal.otherthantotheSecretary,orofficialsoremployeesoftheUnitedStatesDepartmentofAgricultureorotherR:!deralagencies,ortothecourtsInresponsetoasubpoena,ortophysicians.andinemergenciestopharmacistsandotherqualifiedpersons,foruseinthepreparationofantidotes,InaccordancewithsuchdirectionsastheSecretarymaypreSCribe,anyInformationrelatiVetoformulasofproductsacquiredbyauthorityofSection4oftheFUngicide,andRodenticideAct.nUSDA.Am

### Pages 93 -94 * Claimed confidential by submitter*

### Pages 95 -99 *Confidential Statement of Formula may be entitled to confidential treatment*