1

EPA Registration Number 

66330-324 

Vol. 3 
2

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 
3

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. 

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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 uyslCa . I d an Ch emlca . I P ro er f 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 
5

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 

*Manufacturing process information may be entitled to confidential treatment*
6

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 
7

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 
8

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' hYSical an dCb' emlca IP 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 
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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 

*Manufacturing process information may be entitled to confidential treatment* *Product ingredient source information may be entitled to confidential treatment*
10

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 
11

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. 
12

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 
13

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. 
14

~ 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 

•••• 

• • • • • 

478808·00 
15

Arysta LifeScience North America, LLC 

15401 Weston Parkway, Suite 150 

Cary. North Carolina 27513 

Product Name: 

EPA Registration Number: 

Purpose of Submission: 

Date of Submission: 

BIBLIOGRAPHY OF SUBMITTED STUDIES 

Thidiazuron Technical 

66330-324 

Application for Amended Registration 

September 17, 2009 

Solubility of Thidiazuron Technical in Organic Solvents AR-0923 830.7840 

---1-1 -- --- 
16

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.com 
17

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21

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 
22

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 

I 7508P III i.,;;~~; I = 

CONCURENCES 

I I 
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~L-__ ~~~~~~~~~~~~~ __ ~ 

OJ 

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r-!'I Postmark CJ Ralum Recaipt F!!~ 

CJ (!;ndOfOOlnimt Roquirodj I---------j "00 

CJ Re$trictm!OaJ1V(j)yFI!~ Thidiazuron 

(Endorsemont Required) Review Ito xi c t y 

§l data 4/13/09 

~ ~ ~ r~~~~~~~~~~~~~~B~.~Btr~i~s~c~o~e~~~~ , Suite 150 

) 
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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 
25

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 
26

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 

EPA 

4-3-09 

FORM 1 0-,. p. 

( 

:..9 

190) 

~ ~ Printed on Recycled Paper OFFICIAL FILE COpy 
27

~ 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 

, " " , , , , , 

, , "", , , 

" , , , " 

. , 
28

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 

, , , > , , • > 

, 

" 

" 

, ,',-, 

, 

", , 
29

o "'" UNrrED STATES ENVIRONMENTAL PROTECTION AGENCY 401 M Street, S.W. WASHINGTON, D.C. 20460 Form Ap

________ 

n Act Notice:" 

and special ring burden for this G - '------"-9 the i information is estimated to average 0.25 hours per response for registration activities 

--- -" ,,,,,'" , .. " , and completing the necessary forms. Send comments regarding the burden estimat

of information, includi. 'lJ :,u\oi\J=iiu, ''> IU, 

Do not send the form to r . 

Date ,,2009 

9 the burden to: Director, UPf-'E 

Management Division (2137), U.S. Environmental Protection Agency, 401 M 

DATA MATRIX 

EPA Reg. No./File Symbol 66330-324 

Product 

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

Ingredient(s): THIDIAZURON, CAS No. 51707·55·2 

830.1 

\ ACUTE T' 

r CHEM 

--

830A 

).7840 

GENERIC 

Gil c·ALL 

I t:-""LL 

I t:-""LL 

CITE-ALL 

I Study Name 

f and ( 

of Materials, Production Process, Formation of 

Impurities, Preliminary Analysis, Certified 

Limits, Analytical Method 

flask) 

II and ( 

I Acute I 

Acute I 

Primar 

PI 

Skin: 

WOJ'=) 

EPA FOfm 8570·35 (9·97) Eleclron", and Paper versions available. Submil only Paper version. 

I MRIDI 

45601902 

45601903 

520 

280 

45601905 45601906 

45601907 45601908 

45601909 45601910 

I 

I Arysta LifeSci 

Cary, NC 27513 

North I 

Arysta LifeScience North I Arysta LifeScience North I Arysta LifeScience North I 

Arysta LifeScience North I Arysta LifeScience North 

Arysta LifeScience North 

Arysta LifeScience North 

Arysta UfeScience North 

Arysta life_$cience North 

Bayer CropScience LLP 

EPA Co. No. 264 

\ EPA 400 -

I BASF SparkslLC EPA Co. No. t: .... n ,.. 

I 

I Spray Drift Task Force EPA Co. No. 66607 

"' .... ,'--'vv' ... "I-'v" .... e T. F. 

EPA Co. No. 71754 

'"'!o!', ...... " ... oe.o, "", ... ,,,,y' Task Force 

.E:PA Co. No. 

Name and Title: 

Status 

Bill Washburn, Regulatory M
30

.,.. UNITED STATES ENVIRONMENTAL PROTECTION AGENCY Form Ap

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

PapelWork Reduction Act Notice; The public reporting burden for this collection 01 informalion is estimated 10 average 0.25 hours per response for registration activities 

reregistration and special review activities, including lime for reading Ihe instructions and compleling the necessary forms. Send comments regarding Ihe burden estimat

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

Do nol send the form to this address. 

DATA MATRIX 

Date January 24,2009 EPA Reg. No.fFile Symbol 66330-324 

Applicant'sfRegistrant's Name & Address: Product Arysta UfeScience North AmerIca, LLC, 15401 Weston Parkway, Suite 150, Cary, NC 27513 TH!DIAZURON TECHNICAL 

!ngredient(s): THID!AZURON, CAS No. 51707·55-2 

Guideline Reference Number Guideline Study Name MR!D Number Submitter Status 

Nations Ag II, LLC 

EPA Co. No. 72167 

CITE·ALL SRM Chemica!, L TO. Co. 

EPA Co. No. 73631 

CITE-ALL FIFRA Endangered Species T.F. 

EPA Co. No. 73989 

CITE-ALL Ag Handlers Exposure Task Force 

EPA Co. No. 75234 

CITE·ALL Gro-Pro, LLC 

EPA Co. No. 79676 

CITE-ALL Etigra, LLC 

EPA Co. No. 81959 

CITE-ALL Generic Endangered Species T.F. 

EPA Co. No. 84653 

I Signature I Name and Title: Bill Washburn, Regulatory M

EPA Form8570.35tS-97) EleclrooiC and Paper versIOnS avail.ole. Subml only Paper version. 
31

Please read instruclions on reverse before com;: !form. m Approved, OMB No. 2070·0060, Apploval 

; 

.,.,. 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 ; 

~~~('" ""m", "M' o None o Reslricted 

23 

5. N,m" , 01. 

~b){I), my product is simli~ar or iden'tf~~1 i~"~:~~;it\on an~ t· .... I'.':1 

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 , 

" 

I ~Ioe Solobie ""Typ, 0" ; 

DYes' Yes Yeo Melal 

IZJ No 

,~ I No Plastic NO. poe '" ~~~I~~er Glass 

* Certification must Unil Packaging vvgl. wgl. Paper 

be 

Label 

I I 

D Container 

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

~ On Label 

55.0 gal and bulk Onl Ii ; ,pcod,,1 

6. M"''';' Whloh "b,' ;, Affi"d 10 Pmdool ; U Olh" 

~:P"..'I~" 

Section ~ IV 

,. Cootaol POlo! , ,'''m, , ,,(, ,b, , " 10 pm"", 

N~~~L WASHBURN I ;"~EGULATORY MANAGER Code) , No, (""od, ",eo 

, • 

, " 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, , , , '''' , 2. ; 3. T,"e , , 

" , 

~-S~L.)=~ REGULATORY MANAGER , .. > , " , 

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

1/24/09 

,.,',) 

" , , 

EPA (Rev. 8-94) I ; ; are obsolete " ' mow-, I , Copy 
32

Form Approve dOMB 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 p er versions avalla bl e. Submit only Paper version. 
33

o 

- UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

401 M Street, S.W. 

D.C. 20460 

Ap

average 0.25 hours per response for registration activities 

including time for reading the instructions and completing the necessary forms. Send comments regarding the burden estimat

reducing [he burden to: Director, OPPE Information Management Division (2137), U.S. Environmental Protection Agency, 401 M 

DATA MATRIX 

EPA Reg, No./File Symbol 66330·324 

Product 

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

THIDIAZURON, CAS No. 51707·55·2 

3 

Signature Name and Title: 

Bill Washburn, Regulatory M

EPA Form 857p·35 19.97) Elcclroo;caod Paper VefSJons availabl". Submit ooly Pap"r .. ""ioo, 
34

o '" UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 401 M Street, S.W. Form Ap

WASHINGTON, D.C. 20460 

per response lor registration activities 

forms. Send comments regarding the burden estimat

of reducing (2137). U.S. Environmental Protection Agency, 401 M 

DATA MATRIX 

Date 24,2009 

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

Product 

!ngredient(s): THIDIAZURON, CAS No. 51707·55·2 

Name and Title: 

Bill Washburn, Regulatory M

EPA Form 8570·35 ts-97) Eleclronlc and Pa?<"f vem,CID' Submn ooly Paper vermon. 
35

Uni ted States Environmental Protection 

Agency Washington, D.C. 20460 

REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE 

INSTRUCTIONS: Please type or print in ink. Please read carefu!!y1he attached instructions and supply the information requested on Ihis lorm. 

Use additional sheet(s) if necessary. 

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

ARYST A lIFESCIENCE NORTH AMERICA CORPOR) 4092 Thidiazuron 0B-May-2008 

15401 WESTON PARKWAY, SUITE 150 PRODUCT SPECIFIC 

CARY, NC 27513 10 # PDCI-120301-26

EPA Reg. No. 66330-324 

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

R Progress Requiremenl 0 Reports Pattern Substance 

Number T 

0 

c 

0 

l 1 2 3 

830.6313 V SIabHity10 sunl"ight, normal and elel/aled (12,13) A; B, C, 0, 'E, F, G, H, I, TGAJ 

lemperatures, melals, and metallons J,K,L,M,N,O 

830.6314 Oxidizing or reducing action /14) A, B, C, 0, E, F, G, H, I, MP/EP 

J, K, l, M, N, 0 

"830.6315 Aammabllily (15) A, B, C, D, E, F, G, H, J, MP/EP 

v 

• J, K, L, M, N,O 

830.6316 v Exp!odability (16) A, B, C, 0, E, F, G, H, I, MP/EP 

J, K, l, M, N, 0 

830.6317 Storage stabilitY of producl (17) , A, B, C, 0, E, F, G, H, I, MPIEP 

" 

", J, K, L, M, N, Q, 

830.6319 , Miscibility (18) A, B, C, 0, E, F, G, H, I, MPIEP 

J, K, l, M, N, 0 

830.632:0 v Corrosion charaCterisllcs (20) 

, 

A,'B,C,D, E, F, G; 14, I, MPJE'P 

j, K, L, M, N,O 

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

J, K, l, M, N, 0 

830.7000 Y pH ofwaler soruti6ns or suspen"s'lons (24,2si A, B,C, 0, EiF, G, H, J, TGA[IMP/EP 

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

830.7%0 .. " UVNisible absorption A, B, C, 0, E, F, G, H, I, TGAIIPAI 

J, K, L, M, N, 0 

, 

-

. 

Viscosity 126) A, B;O, D, E, F, G, H'-,f, W/EP 

, 

.. J, K, L,,¥, N;O ",,," 

'. Melting point/melting range (27,28) A, B,C,D, E,F,G, H, I, TGAI 

! , ""' J, K, l, M, N, 0 " " 

" " 

, 

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

Initial to indicate certilication as to information on 1his page Uu Date [tuU text of certilica1ion is on page one). 'O/
36

United States Environmental Protection 

Agency Washington, D_C. 20460 

REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE 

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

Use additional sheet(s) if necessary. 

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

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

15401 WESTON PARKWAY, SUITE 

t50 PRODUCT SPECIFIC 

CARY, NC 275 t3 ID # PDCI-120301-26

EPA Reg. No. 66330-324 

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

Requirement R Progress Pattern Substance 

0 Reports Number T 0 

c 0 

L , 2 3 

830.7220 Boiffng poinVboffing range (29,30) A, B, C, D; 'E, F, G, H, I, TGAI 

v 

J, K, L,M, N,O 

830.7300 , Density/relative density (31 .32) A, S, C, D, E, F, G, H, I, TGAIIMP/EP 

J, K, L, M, N, 0 

'830.7370 I Dissociation oonstiml in water (42,43) A, B, C, D, E, F, G, H, I, J, K, L.f.1, N, 0 TGAI'or PAl 

830.7550 , Partition coeH'lcient (n'octanollwater), shake flask (44) A, S, C, D, E, F, G, H, I, TGAI/PAI 

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

830.7570 " Partition coefficient (n-octanoVwater), estimation by (451 A, B', C; D, E, F, G, H, I, TGAliPAI 

liquid chromatography J, K, L,M, N,O 

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

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

830.7860 Watersolubllity, generatorcofumn method (471 A, B,C, D,E; F, G, H, I, TGAlor PAl 

" J, K, 

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

v 

J, K, L, M, N, 0 

Rggulr.!!!!!!:Oa-,C2nV!nIi2D;'Id 

. 

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

, J,K,l,M,N,O 

. 

870."/2OC .' Acute dermaJ toxicity' (33 ,34) A, 'B,'C, D, E, F, G, H, I;' TGAI,EP,dilute EP? 

'. -

--

, " . 

870.1300 Acute inhalation toxicity (35) A, B, C, D, E, F, G, H, I, TGAI & EP 

.. J,K,l,M,N,O , " , 

, .. . 

. , , , ' , 

, , , 

, , , " , , , 

, 

, 

Initial to indicate certification as to information on this page t:w Date (full text of certification IS on page one). 'Of 'Or o
37

United States Environmental Protection 

Agency Washington, D.C. 20460 

REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE 

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

Use additional sheet(s) if necessary. 

1. Company Name and Address 2. Case /I and Name 3. Date and Type of DCI an

ARYSTA LlFESCIENCE NORTH AMERICA CORPOR} 4092 Thidiazuron 08-May-2008 

15401 WESTON PARKWAY, SUITE 150 PRODUCT SPECIFIC 

CARY, NC 27513 10 # PDCI-120301·26

EPA Reg. No. 66330-324 

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

R Progress Requirement 0 Pattern Substance 

Number T Reports 

0 

c 

0 

L , 2 3 

870.2400 Acute eye irritation (37) A, S, C, D, E',' F, G, H, I, TGAI& EP 

J, K, L,,}.-1, N, 0 

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

J,K,L,M,N,O 

870.2600 Skin sensitiZatIOn (40,41) A, 8, C, D, E, F, G, H, I, TGAI &EP 

J, K, L, M, N,O 

Initial fo indicate certificafion as to information on this page Qju Dafe (full text of certification is on page one). 8(0
38

-1ItfiJM'Z.bIZiJ/J '7t:LHJ..JICifL 

United States Environmental Protection 

Agency Washington, D.C. 20460 

REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE 

INSTRUCTIONS; Please type or print in ink. Please read caretully the attached instructions and supply the intormation requested on this form. 

Use additional sheet(s) it necessary. 

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

ARYSTA lIFESCIENCE NORTH AMERICA CORPORI 4092 Thidiazuron 08-May-2008 

15401 WESTON PARKWAY, SUITE 150 PRODUCT SPECIFIC 

CARY, NC 27513 ID # PDCI-120301-26

EPA Reg. No. 66330-324 

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

R Progress Requirement 0 Reports Pattern Substance 

Number T 

0 

C 

0 

L 1 2 3 

Product Cheml A. ulr •••• e. .onUo",' 

emi al . 

630. t550 v Productldenlity and composition (I) A, S, C, D, E, F, G, H, I, TGAI/MP/EP 

J, K, l, M, N,O 

830.1600 V DesCription 01 materials used to ptoduce the product (2) A, Sf C, D,'E, F, G, H, I, TGAI/MP/EP 

". L,t,l. N.O '. 

830. t620 v Description of production process (3) A, S, C, D, E, F, G, H, I, TGA' 

J, K, L, M, N, 0 

'8'30.t650 Description of formulation process (4) A,B,b, Cf, E, F,G,H, I, MP/EP 

J, Kil, M, N,p 

830.1670 , Discussion of formation of impurities (s) A, B, C, D, E, F, G, H, I, 

J, K, l, M, N, 0 

TGAJlMP/EP 

830.1700 , Preliminary analysis (6,7,8) A, B, C, D, E, F, G, H, I, TGAI 

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

830. t750 V Certified limits (9 ,to) A, S, C, D, E, F, G, H, I, TGAI/MP/EP 

". K. L. M. N. 0 

830.1800 v E"n'rorcement analytlciil'meihod (11) . . A, S, C, D, E,.F', 'G, H,'I, TGAIiMPiEP 

".K, L.M.N.O .' 

830.E.'302.: ·Y. Color (t9) A, S, C, D, E, F, G, H, I, TGAIIMP/EP 

J, K, L, M, N, 0 

'830.6:C3- \/'::' ' Physical state (22) 

'.' 

A, B. C, D, E;i=; G, H, 1, TGAliMp/E'P 

-

.. 

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

€.30.6304 Odor (23) A, S, C, D, E, F, G, H, I, TGAJlMP/EP 

• · - J, K, L, M, N, 0 · . . · . . . . . 

,,{o. Ceriili<:aticn, 'I Cef<l:iry that the statements made on this form and all attachments are true, accurate, and complete. I acknowledge that any ft. Date 

knowingly false or mis1e.a'ding statement may be punishable by law 8

Signature and Title of Company's Authorized Representative : Q )00 u!dv f,,\ 

t2. Name of Company (::)''''''o\c. L,'1@ S:,';" 1\\nJ+iA AflAP( irn U.rv 13. Phone Numbet 
39

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 

1 l/~lr. )LJi ") , 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 

" > , , , , 
40

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 
41

. 

w .J:A5.C .. C. !< C I • r; " "UC" 

United States Environmental Protection 

Agency Washington, D.C. 20460 

DATA CALL-IN RESPONSE 

7 (Jefr/if/Dr 

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

Use additional shee\(s) if necessary. 

1. Company Name and Address 2. Case # and Name 3. Date and Type 01 DCI an

ARYSTA LlFESCIENCE NORTH AMERICA CORPOR 4092 Thidiazuron 08·May-2008 

15401 WESTON PARKWAY, SUITE 150 Chemical # and Name 120301 PRODUCT SPECIFIC 

CARY, NC 27513 Thidiazuron ID # PDCI-120301·

4. EPA 5. I wish to 6. Generic Data 7. Product Specitic Data 

Product cancel this 

Registration product regis- 6a, I am claiming a Generic ab. I agree to satisfy Generic 7a. My product is an MUP and 

tratfon volun- Data Exemption because I Data requirements as indicated I agree to satisfy the MUP 

tarily obtain the active ingredient on the attached form entitled requirements on the attached 

from the source EPA regis· "Requirements Status and form entitled 'Requirements 

tration number listed below. Registrant's Response." Status and Registrant's 

Response.' 

66330-323 :;.' X N.A. NA 

66330·324 NA N.A. )( 66330-333 t { N.A. NA 66330-334 ',( NA. NA. 

66330·344- N.A. N:A. 

66330-364 N.A. NA 

C 

. : .: . c 

c 

: !! Certlhcatloo I cenify:ihat the statements made on thiS form and all attachments are true, accurate, and complete. I acknowledge that any 

• mlslegplng statement may be punishable by fine, Imprisonment or both under applicable law. 

9. Date 

Signature and Title of Company's Authorized WCl.."'Jl&uv- I ·Aesotc1lXy MCf\csec e/

to. Name of Company Rn.;S1c ufcSc.'C',,",ce N.CJAVI AmefiCQ LLQ 11. Phone Number 
42

PI£;3se ((lad inSlructions on rever~e beforE' comp I!tlll.g ""Tn. F A ,~ eerove d ""'18 2070-0060 . NO. 

0 Reg'.:Jlration opp Identifier Number 

.. EPA United States 

.." Environmental Protection Agency Washington, DC 20460 0 Amendment 

!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 sedton ii s are ob " soe e, W"' . " te EPA Ftte Copy (ongl at) y, Ilow ' '.' Applicant Copy 
43

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." 
44

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) 
45

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. 

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

*Manufacturing process information may be entitled to confidential treatment*
46

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) 
47

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 

,,' ) 

" , 

2 
48

WARRANTY 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) 3 
49

DP 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 
50

"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 

*Manufacturing process information may be entitled to confidential treatment*
51

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. 

*Manufacturing process information may be entitled to confidential treatment*
52

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 901-432-5031 
Pages 53-60 Copyrighted material removed
61

DP 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: 101 ~ ,-\, 

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* 
67

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:: 

9 

*Manufacturing process information may be entitled to confidential treatment*
68

DP 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 

*Manufacturing process information may be entitled to confidential treatment*
Pages 69-75 Copyrighted material removed
76

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. 
77

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.com 
78

Page 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. 
79

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.com 
80

Please read in5truclkmson reverse before completir, Form APprove' > o. 2070·0060 " OPP Identifier Number 

~ EPA 

United States D Registration 

'"' Environmental Protection Agency 

Washington, DC 0" Amendment 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 (StaottJed) 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 Copy 
81

Arysta LifeScience North America Corporation 

15401 Weston Parkway, Suite 150 

Cary, North Carolina 27513 

Product Name: 

EPA Registration Number: 

BIBLIOGRAPHY OF SUBMITTED STUDIES 

Thidiazuron Technical 

66330-324 

Purpose of Submission: 

Date of Submission: 

Application to Amend Registration to Add Alternate Manufacturing Loca

June 29, 2007 

1 of 1 

of Thidiaz:J:,o.1 TGAI 

I -Validalior. of Analytical Methodology for the Assay of 

Ac!ive In£rgdient and Related Significant Impurities of 

ThidiazL.;jon TGAI and Subsequent 5-Batch Analysis of 

TGAI 

NC-2007-006 

OPPTS 

830.1700 830.1800 

Group AProduct 

Chemistry 
82

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 
83

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, 
84

at (703) 305-6249. 

Sincerely, 

sing Staff 

rmation echnology & Resources Management Division 
85

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: 

CSr 
86

Regulatory 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----­ , 
87

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 

Washington, DC 0 Amendment 20460 

0 Other 

aS7 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 
88

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.com 
89

Page 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. 
90

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.com 
91

Arysta LifeScience North America Corporation 

15401 Weston Parkway, Suite 150 

Cary, North Carolina 27513 

Product Name: 

EPA Registration Number: 

BIBLIOGRAPHY OF SUBMITTED STUDIES 

Thidiazuron Technical 

66330-324 

Purpose of Submission: Application to Amend Registration to Add Alternate Manufacturing Loca

Date of Submission: June 29. 2007 

1 of 1 

of Thidiaz";m TGAI 

I '-ValidaJor. of Analytical Methodology for the Assay of 

Ac!ive In£r'3dient and Related Significant Impurities of 

ThidiazL.:;-on TGAI and Subsequent Analysis of 

NC-2007-006 

OPPTS 

830.1700 830.1800 

Group AProduct 

Chemistry 
92

PR FORM 9-11 

(MARCtf 2006) 

§ rmn,1 I n I'll flV! L' \ ( '3 (

REGISTRATioN NO. 

CONFIDENTIAL STATEMENT OF FORMULA ENCL

DATE 

SUBMITTED 

SUBMITTED BY (./) 

APPLICANT BASIC SUPPUER Do Not Write Comm

formula, or Parts of 

on This Envelo

NOTE 

It shall be unlawful-for any person to use 

or to reveal. other than to the Secretary, or o

the United States Department of Agriculture or 

or to the courts In response to a subpoena, 

emergencies to pharmacists and other quali

the preparation of antidotes, In accordance the Secretary may preSCribe, any Information 

products acquired by authority of Section 4 of 

FUngicide, and Rodenticide Act. n 
Pages 93-94 * Claimed confidential by submitter*
Pages 95-99 *Confidential Statement of Formula may be entitled to confidential treatment*