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# Material Sent for Data Extraction Reg # ___ '8.::..;50=--1_8,--_' 0 __ 

# Description: ____ R_e....::'1_',

# 5_cTf';_VC_~_<Y)_· _____ _ 

# IX! Material(s) Sent to Data Extraction Contractors:**~** New Stamped Label Dated 

# 02/;28/'1 

# o Notification Dated ____ _ New CSF(s) Dated 1);2&/' I 

# o Other: _________ _ 

# JXl Decision #: __ 4-'..3=-=.8..:..d._ 

# w



# _Lf-,--_ 

# o Other Action/Comments:________ _

Attach this coversheet to the top of the material orjacket. It 

# must be well organized and clipped together, NOT STAPLED. Then give the material with this coversheet to staff in the Information Services Center (Room S-4900). 

# Reviewer: __**~M"-"i'-'-n=d-l-y_'O=n'_"d=i=s.!...!h** 

# _______ _ Phone: 703-605-0723 Division: RD/PM Team 25 Date: ________**3~/'-\/_,-'-J** ________ _U.S. ENVIRONMENTAL PROTECTION AGENCY 

### Office of Pesticide Programs Registration Division (7505P) Ariel Rios Building 1200 Pennsylvania Ave., NW

Washington, D.C. 20460 NOTICE OF PESTICIDE: 

## ...2L Registration

_ Reregistration (under FIFRA, as amended) EPA Registration Number: Date of Issuance:


### 85678-10 

## FEc 28 2011

Term of Issuance: 

### Unconditional Name of Pesticide Product 

### Tribufos Technical RedEagle International, LLC c/o Wagner Regulatory Associates, Inc. 1925 East Edgewood Drive, Suite 105 Lakeland, FL 33803 P.O. Box 640 Hockessin, DE 19707-0640

On the basis of information furnished by the registrant, the above named pesticide is hereby registered/reregistered under the Federal Insecticide, Fungicide and Rodenticide Ad. Registration is in no way to be construed as an endorsement or recommendation ofthis product by the Agency. In order to proted heaRh and the environment, the Administrator, on his motion, may at anytime suspend or cancel the registration of a pesticide in accordance with the Act. The acceptance of any name in connection with the registration ofa product under this Act is not to be conslrued as giving the reg·lstrant a right to exclusive use ofthe name or to its use if it has been covered by others. 

### This product is registered in accordance WITh FIFRA provided that you: 1. SubmIT and/or cite all data required for registration review/reregistration ofyour produci when the Agency requires all registrants of similar products to submit data. 2. Submit one-year Storage StabHity (Guideline 830.6317) and Corrosion Characteristics (Guideline 830.6320) studies within eighteen (18) months from the date ofthis notice. The Basic Confidential Statement of Formula (CSF) dated January 26, 2011 is acceptable. A stamped copy ofthe label is enclosed for your records. Submit one (1) copy ofthe revised final printed label before you release the product for shipment. Products shipped after eighteen (18) months from the date ofthis notice or the next printing ofthe label, whichever occurs first, must bear the new revised label. If these conditions are not complied with, the registration will be subject to cancellation in accordance with FIFRA §6(e). 

### Your release for shipment ofthe product constitutes acceptance ofthese conditions. If you have any questions, please contact Mindy Ondish at**703-605~0723** 

### or at ondish.mindy@epa.gov.

80 Davis 

### Product Manager 25 Herbicide Branch Registration Division (7505P) Date: 

## FEB 28 201185678-10.20110215.V1 Draft Label- Initial Registration 

# ACCEPTED FEB 28 2011 Under the Federal Insecticide, Fungicide, and Rodenticide Act as amended, for the pesticide registered under 

## 8 EPA Reg. No. 

### 85<07 -10 

### FOR USE IN THE MANUFACTURE OF COTTON DEFOLIANTS Ingredients By WI. Active Ingredients: Tribufos (S, S, S,-tributyl phosphoro-trithioate)

..................................................................99.5% Other Ingredients:

............................................................................................................ 0.5% Total

.................................................................................................................................100.00% EPA Reg. No. 85678-10 EPA Est. No. __

IF 

# • SWALLOWED 

# • • • IFON SKIN 

# • OR 

# • CLOTHING 

# • IF INHALED 

# • 

# • • Net Contents: 275 gallon KEEP OUT OF REACH OF CHILDREN 

# WARNING FIRST AID Call a poison control center or doctor immediately for treatment advice. Have person sip a glass ofwater if able to swallow. Do not induce vomiting unless told to do so by a poison control center or doctor. Do not give anything by mouth to an unconscious person, Take off contaminated clothing. Rinse skin immediately with plenty ofwaterfor 15-20 minutes. Call a poison control center or doctor for treatment advice, Move person to fresh a'lr, If person is not breathing, call 911 or an ambulance, then give artificial respiration, preferably mouth-to-mouth, if possible. Call a poison control center or doctor for further treatment advice, Have the product or container label with you when calling a poison control center or going in for treatment. For 24-hour medical emergency assistance (human or animal) call 1-800-222-1222. For chemical emergency assistance (spill, leak, fire, or accident) call ChemTrec at 1-800-424-9300. NOTE TO PHYSICIAN: This product inhibits cholinesterase resulting in stimUlation ofthe central nelVous system, the parasympathetic nervous system and the somatic motor nelVes. Poisoning with this product also results in cardiovascular and respiratory symptoms which must be treated as separate pathological entities apart from the cholinergic effects. Use atropine sulfate to reverse chOlinergic symptoms; maintain a systematic, symptomatic treatment ofthe cardiovascular and respiratory effects, even though the cholinergic symptoms have ceased. Pralidoxime (2-PAM) may be indicated as antidotal therapy. Contact a medical toxicologist, or Doison center for Quidance on the optimal utilization of 2-PAM. Do not aive central nervous Page 1 of48S678-1O.2011021S.Vl Draft LabeJ- Initial Registration 

### system depressants. Watch for pulmonary edema, which may develop in serious cases of

oisonin even after 12 hours. The use of ox en is recommended in case of res irato distress. PRECAUTIONARY STATEMENTS HAZARDS TO HUMANS AND DOMESTIC ANIMALS WARNING: May be fatal if swallowed or absorbed through the skin. Hannful if inhaled. Do not get in eyes, on skin, or on clothing. Avoid breathing spray mist. Wash hands thoroughly with soap and water after handling and before eating, drinking, chewing gum, using tobacco, or using the toilet. Remove contaminated clothing and wash clothing before reuse. PHYSICAL OR CHEMICAL HAZARDS This product exhibits oxidizing potential. Do not mix or contact with oxidizing agent to prevent such hazard. ENVIRONMENTAL HAZARDS This product is toxic to terrestrial and aquatic plants, fish, and aquatic vertebrates. 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 Pollutant Discharge Elimination System (NPDES) permit 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. Do not contaminate water when disposing of equipment washwaters. For guidance, contact your State Water Board or Regional Office ofthe Environmental Protection Agency.

Page 2of485678-10.20110215.V1 Draft Label- Initial Registration 

### STORAGE AND DISPOSAL Do not contaminate water, food or feed by storage, or disposal. PESTICIDE STORAGE: Store in a cool, dry place. Protect from excessive heat. Do not store or transport near food or feed. PESTICIDE DISPOSAL: Pesticide wastes are acutely hazardous. Improper disposal of excess pesticide is a violation of Federal Law. If these wastes cannot be disposed of by use according to label instructions, contact your State Pesticide or Environmental Control Agency, or the Hazardous Waste representative 

### at the nearest EPA Regional Office for guidance. CONTAINER DISPOSAL: Refillable container: Refill this container with this pesticide only. Do not reuse this container for any other purpose. Cleaning the container before frnal disposal is the responsibility of the person disposing of the container. Cleaning before refilling is the responsibility of the refiller. To clean the container before final disposal, empty the remaining contents from this container into manufacturing equipment or mix tank. Fill the container about 10 percent full with water. Agitate vigorously or recirculate water with the pump for 2 minutes. Pour or pump rinsate into manufacturing equipment or rinsate collection system. Repeat this rinsing procedure two more times. DIRECTIONS FOR USE It is a violation 

### of Federal law to use this product in a manner inconsistent with its labeling. This product is intended for further manufacturing of pesticides only. All formulators are responsible for obtaining EPA registration for their formulated product. Only for formulation into a defoliant for use on cotton. This product may be used 

## to formulate products for any additional use(s) not listed on the manufacturer's use product label if the formulator, user group, or grower has complied with U.S. EPA submission requirements regarding the support of such use(s).

Page 3 of4

### 8S678-10.2011021S.Vl Draft Label- Initial Registration 

### WARRANTY AND DISCLAIMER STATEMENT Read the entire Directions for Use, Conditions, Disclaimer of Warranties and Limitations of Liability before using this product. If terms are not acceptable, return the unopened product container at once. By using this product, user or buyer accepts the following Conditions, Disclaimer of Warranties and 

### Limitations of Liability. Treatment of highly mechanically damaged seed, or seed of known low vigor and poor quality may result in reduced germination and/or reduction of seed and seedling vigor. Treat and conduct germination tests on a small portion of seed before committing the total seed lot to a selected chemical treatment. Due to seed quality conditions beyond the control of RedEagle International LLC, no claims are made to guarantee germination of carryMover seed. 

### CONDITIONS: The directions for use of this product are believed to be adequate and must be followed carefully. However, it is impossible to eliminate all risks associated with the use of this product. Crop injury, ineffectiveness or other unintended consequences may result because of such factors as weather conditions, presence of other materials, or the manner of use or application, ali of 

### which are beyond the control of Red Eagle International LLC. To the extent allowable under State law, all such risks shall be assumed by the user or buyer. 

### DISCLAIMER OF WARRANTIES: TO THE EXTENT CONSISTENT WITH APPLICABLE LAW, REDEAGLE INTERNATIONAL LLC MAKES NO WARRANTIES, EXPRESS OR IMPLIED, OF MERCHANTABILITY OR OF FITNESS FOR A PARTICULAR PURPOSE OR OTHERWISE, THAT EXTEND BEYOND THE STATEMENTS MADE ON THIS LABEL. No agent of RedEagle International LLC is authorized to make any warranties beyond those contained herein or to modify 

### the warranties contained herein. TO THE EXTENT CONSISTENT WITH APPLICABLE LAW, REDEAGLE INTERNATIONAL LLC DISCLAIMS ANY LIABILITY WHATSOEVER FOR SPECIAL, INCIDENTAL OR CONSEQUENTIAL DAMAGES RESULTING FROM THE USE OR HANDLING OF THIS PRODUCT. LIMITATIONS OF LIABILITY: TO THE EXTENT CONSISTENT WITH APPLICABLE LAW, THE EXCLUSIVE REMEDY OF THE USER OR BUYER FOR ANY AND ALL LOSSES, INJURIES OR DAMAGES RESULTING FROM THE USE OR HANDLING OF THIS PRODUCT, WHETHER IN CONTRACT, WARRANTY, TORT, NEGLIGENCE, STRICT LIABILITY OR OTHERWISE, SHALL NOT EXCEED THE PURCHASE PRICE PAID, OR AT RED EAGLE INTERNATIONAL LLC'S ELECTION, THE REPLACEMENT OF PRODUCT.
Manufactured for: 

### Red Eagle International LLC 1925 E Edgewood Drive Lakeland, FL 33803

Page4of4

# REGISTRATION NOTE FOR RECORD EPA Reg. No.! File Symbol: 85678-RN (10) Product Name: Tribufos Technical Application Date: 8/6/10 Action Description: 

### R310 PRODUCT CHEMISTRY: (DP382143; 11/22/10) Basic CSF 1/26111 Submitted own product chemistry studies (MRID 48179801-04) Subsequently submitted revised study updating viscosity information (MRID 48369301). was not reviewed 

## by TRB since viscosity information was already in previous study and information has not changed. Data Gap: Storage Stability 

### & Corrosion Characteristics ACUTE TOXICITY: (DP382144; 1/24/11) Substantially similar to Reg# 5481-9022 Citing acute tox 6pack data from cited product Tox Category II for Acute Oral 

### & Acute Dermal Tox Category III for Acute Inhalation 

### & Primary Skin Irritation Tox Category IV for Primary Eye Irritation Not a Skin Sensitizer 

### GENERIC DATA: Cite-all for tribufos generic data; however Bayer recently transferred data rights to Amvac. whom is not listed on the data submitters' list. Amvac petitioned to deny registration due to failure to compensate data. Agent submitted offer to pay letter dated 2/11/11 from registrant to Amvac for relevant data. LABEL REVIEW: Tributos technical label. sent comments via email on 2/15/11 Revised label submitted 2/15/11 incorporating changes COMMENTS:
DECISION: Unconditional registration with data requirements Reviewer: 

# I IA: 

## .v

## ~JA>'k 

# I Date: 

# I "'-;"<'+

## III**85678~**10 t.20110215.V1.pdf

Good afternoon, please find the revised label. If you have any questions, please let me know. Thank you, catherine M. Byrd Regulatory Associate P.O. Box 640 7460 Lancaster Pike, Suite 9 Hockessin, Delaware 19707 P: 302.234.2780 F: 302.234.7570 www.wagnerreg.com -----Original Message----- From: Ondish.Mindy@epamail.epa.gov [mailto:Ondish.Mindy@epamail.epa.gov] Sent: Tuesday, February 15, 2011 2:56 PM To: Catherine Byrd Subject: 85678-RN Tribufos Technical label revision
Dear Ms. Byrd, The proposed label for 85678-RN (Tribufos Technical) 

### is unacceptable. please make the changes listed below and resubmit for review. Since the PRIA due date is on 2/28/11, please resubmit label electronically in pdf 

### in response to this email by COB Monday, February 21, 2011. 1. Change "Related Compounds" to "Other Ingredients". 2. Change EPA Reg. No. to "85678-10". 3. Change the order of the FIRST AID statements to "If Swallowed", "If on Skin or Clothing", then "If Inhaled". The "If in Eyes" statement is optional for this product. If you wish to keep 

### it, place it last. 4. Change the HAZARDS TO HUMANS AND DOMESTIC ANIMALS statement to "WARNING; May be fatal if swallowed or absorbed through the skin. Harmful if inhaled. Do not get 

### in eyes, on skin, or on clothing. Avoid breathing spray mist. Wash hands thoroughly with soap and water ... " Sincerely, Mindy Ondish Biologist / Risk Manager Herbicide Branch (PM Team 25) Registration Division [7505P) Office of Pesticide Programs85678-Tribufos Tech-Vl-06AUG10 

### Draft**LClu~I-lnitial** 

### Registration



# Tribufos Technical lX'aCcep-t<\b\-e..
-

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### FOR USE IN THE MANUFACTURE OF COTTON**DEFOLl~NT$** 

### , 

## , Ingredients By,WI. ;-;- ;-;- 

### Active Ingredients:**~'H:>** 

### Tribufos (S, S, S,-tributyl phosphoro-trithioate)""""""""""""""""""""",,,,,,,,,,,,,,,,,,,,,,

## "9,!l,,j'i'/' -Related CompoHHds: ,...**.I~L.I.<:\:l)&"'i.0.T.~**

## ..............................................................\),51%·

Total

.................................

### q~

# .................... ................................................................... 100.00%

'> 

# / \, EPA Reg. No. 85678- 10 

### EPA Esl. No.__ Net Contents: 275 gallon

IF ,; 

# • SWALLOWED 

# • • • IF IN EYES 

# • (O\'"f<'-'') 

# • • IF ON SKIN 

## v 

# • OR 

# • CLOTHING 

# • IF INHALED I 

# • • • KEEP OUT OF REACH OF CHILDREN 

# WARNING /' FIRST AID Call a poison control center or doctor immediately for treatment advice, Have person sip a glass ofwater if able to swallow. 

### Do not induce vomiting unless told to do so by a poison control center or doctor. Do not give anything by mouth to an unconscious person. Hold eye open and rinse slowly 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. 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. Move person to fresh air. If person is not breathing, call 911 or an ambulance, then give artificial 

### respiration, preferably mouth-to-mouth, if possible. Call a poison control center or doctorfor further treatment advice. Have the product or container label with you when calling a pOison control center or going in for treatment. For 24-hour medical emergency assistance (human or animal) call1-BOO-222-1222. For chemical emergency assistance (spill, leak, fire, or accident) call ChemTrec at 1-800-424-9300. NOTE TO PHYSICIAN: This product inhibits cholinesterase resulting in stimulation ofthe central 

### nervous system, the parasympathetic nervous system and the somatic motor nerves. Poisoning with this product also results in cardiovascular and respiratory symptoms which must be treated as separate pathological entities apartfrom the**choliner~ic** 

### effects. Page 1 of4 

# iO85678-Tribufos Tech-Vl-06AUG10 Draft lauel- Init'ral Registration 

### Use atropine sulfate to reverse cholinergic symptoms; maintain a systematic, symptomatic treatment ofthe cardiovascular and respiratory effects, even though the cholinergic symptoms have ceased. Pralidoxime (2-PAM) may be indicated as antidotal therapy. Contact a medical toxicologist, or poison center for guidance on the optimal utilization of2-PAM. Do not give central neIV';'"s 

### system depressants, Watch for pulmonary edema, which may develop in serious cases cf > 

## ! DoisoninQ even after 12 hours. The use 

## of oXYGen is recommended in case of rsspiratory·dis'tress. , , 

### PRECAUTIONARY STATEMENTS

. :' HAZARDS TO HUMANS AND DOMESTIC ANIMALS

... , j--k;\f'I'\'\..f....\. ..

# t- \i')v\.o..\b1.. ,) : ' , ;**5~**, , , 

### WARNING: 

### May be fatal if swallowed or absorbed through the ski,( Do not gd':n eyes'qr oh clothing. Wash hands thoroughly with soap and water after handling and before eating, drinking, "newlng gu';;:) using tobacco, or using the toilet. Remove contaminated clothing and wash clothing bef9:':':';.use. / PHYSICAL OR CHEMICAL HAZARDS

# ,Av~r'~'::;~,,~. This product exhibits oxidizing potential. Do not mix or contact with oxidizing agent to prevent such hazard. ENVIRONMENTAL HAZARDS 

### This product is toxic to terrestrial and aquatic plants, fish, and aquatic vertebrates. 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 Pollutant Discharge Elimination System (NPDES) permit and the permitting authority has been notified in writing prior to discharge. Do not discharge effluent containing th',s product to sewer systems without previously notifying the local sewage treatment plant authority. Do not contaminate water when disposing of eqUipment washwaters. For guidance, contact your State Water Board or Regional Office of the Environmental Protection Agency.

Page 2 of485678*Tribufos Tech*Vl*06AUG10 Draft LGluel* Initial Registration 

### STORAGE AND DISPOSAL Do not contaminate water, food orfeed by storage, or disposal. , PESTICIDE STORAGE: store in a cool, dry place. Protect from excessive heat. Do hOt store or transport near food orfeed.

.", , PESTICIDE DISPOSAL: Pesticide wastes are acutely hazardous. Improper 'disposal of excess pesticide is a violation of Federal Law. If these wastes cannot be disposed: of b

## l use a';cording to label instructions, contact your State Pesticide or Environmental Control Agency,: or the' Hazardous Waste representative at the nearest EPA Regional Office for guidance. ': ,", CONTAINER DISPOSAL: " : ' , " " Refillable container: Refill this container with this pesticide only. Do not reuse::his con,tainer for any other purpose. Cleaning the container before final disposal is the responsibility 

## d'the person disposing of the container. Cleaning before refIlling is the responsibility of the refiller.,Tb tJean the container before final disposal, empty the remaining contents from this container into manufacturing equipment or mix tank. Fill the container about 10 percent full with water. Agitate vigorously or recirculate water with the pump for 2 minutes. Pour or pump rinsate into manufacturing equipment or rinsate collection system. Repeat this rinsing procedure two more times. DIRECTIONS FOR USE It is a violation of Federal law to use this product in a manner inconsistent with its labeling. This product is intended for further manufacturing of pesticides only. All formulators are responsible for obtaining EPA registration for their formulated product. Only for formulation into a defoliant for use on cotton. This product may be used to formulate products for any additional use(s) not listed on the manufacturer's use product label if the formulator, user group, or grower has complied with U.S. EPA submission requirements regarding the support of such use(s).

Page 3 of 485678-Tribufos Tech-Vl-06AUG10 Draft La ...cl-Initial Registration 

### WARRANTY AND 

### DISCLAIMER STATEMENT Read the entire Directions for Use, Conditions, Disclaimer of Warranties and Limitations of Liability before using this product. If terms are not acceptable, return the unopened product container at once. By using this product, user or buyer accepts the following Conditions, Disclaimer of Warranties and Limitations of Liability. Treatment of highly mechanically damaged seed, or seed of known low vigor and poor quality may result in reduced germination and/or reduction of seed and seedling vigor. Treat and conduct germination tests on a small portion of seed before committing the total seed lot to a selected chemical treatment. Due to seed quality conditions beyond the control of Red Eagle International LLC, no claims are made to guarantee germination of carry-over seed. CONDITIONS: The directions for use of this product are believed to be adequate and must be followed carefully. However, it is impossible to eliminate all risks associated with the use of this product. Crop injury, ineffectiveness or other unintended consequences may result because of such factors as weather conditions, presence of other materials, or the manner of use or application, all of which are beyond the control of Red Eagle International LLC. To the extent allowable under State law, all such risks shall be assumed by the user or buyer. DISCLAIMER OF WARRANTIES: TO THE EXTENT CONSISTENT WITH APPLICABLE LAW, REDEAGLE INTERNATIONAL LLC MAKES NO WARRANTIES, EXPRESS OR IMPLIED, OF MERCHANTABILITY OR OF FITNESS FOR A PARTICULAR PURPOSE OR OTHERWISE, THAT EXTEND BEYOND THE STATEMENTS MADE ON THIS LABEL. No agent of RedEagle International LLC is authorized to make any warranties beyond those contained herein or to mOdify the warranties contained herein. TO THE EXTENT CONSISTENT WITH APPLICABLE LAW, REDEAGLE INTERNATIONAL LLC DISCLAIMS ANY LIABILITY WHATSOEVER FOR SPECIAL, INCIDENTAL OR CONSEQUENTIAL DAMAGES RESULTING FROM THE USE OR HANDLING OF THIS PRODUCT. LIMITATIONS OF LIABILITY: TO THE EXTENT CONSISTENT WITH APPLICABLE LAW, THE EXCLUSIVE REMEDY OF THE USER OR BUYER FOR ANY AND ALL LOSSES, INJURIES OR DAMAGES RESULTING FROM THE USE OR HANDLING OF THIS PRODUCT, WHETHER IN CONTRACT, WARRANTY, TORT, NEGLIGENCE, STRICT LIABILITY OR OTHERWISE, SHALL NOT EXCEED THE PURCHASE PRICE PAID, OR AT RED EAGLE INTERNATIONAL LLC'S ELECTION, THE REPLACEMENT OF PRODUCT.
Manufactured for: RedEagle International LLC 1925 E Edgewood Drive Lakeland, FL 33803

Page 4 of4**UNIl~"** STATES ENVIRONMENTAL**PROTECTIt)~** AGENCY WASHINGTON, D.C. 20460


### February 3, 2011
CHERYL WAGNER WAGNER REGULATORY ASSOCIATES, INC. REDEAGLE INTERNATIONAL LLC 7460 LANCASTERPIKE, SUITE 9, PO Box 640 HOCKESSIN, DE 19707-0640 Report ofAnalysis for Compliance with PRNotice 86-5 OFFICE OF PREVENTION, PESTICIDES AND TOXIC SUBSTANCES



### Thank you for your 

### submittal of31-JAN-ll. Our staffhas completed a preliminary analysis ofthe 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 PRNotice 86-5. A copy ofyour bibliography is enclosed, annotated with Master Record ill's (MRIDs) assigned to each document submitted. Please use these numbers in 

### all future references to these 

### documents. Thank you for your cooperation. Ifyau have any questions concerning this data submission, please raise them with the cognizant Product Manager, to whom the data have been released.

### 483683·00
January 25, 2011 Document Processing Desk ATTN: Jim Tompkins, PM Team 25 Registration Division Wagner Regulatory Assoclates, Inc. P.O. Box 640 U.S. Enviromnental Protection Agency Office ofPesticide Programs (7504P) Room S-4900, One Potomac Yard 2777 South Crystal Drive 7460 Lancaster Pike, Suite 9 Hockessin, Delaware 19707 Arlington, Virginia 22202-450 1 Dear

### Mr. Tompkins, Subject: Application for Registration

- RedEagle International LLC

- Tribufos Technical EPA File Symbo185678 Submission ofAmended Study (MRID 48179804) Wagner Regulatory Associates, Inc., as agent for RedEagle International LLC, respectfullysubmits an amended study for MRlD 48179804). This study was amended to include viscosity (830.7100) and replaces the previously submitted study. In support ofthis submission, the following documents and studies are attached:

• Letter from RedEagle International LLC appointing Wagner Regulatory Associates, Inc. as its agent • Data Transmittal Document 

### 48389301. Physical and Chemical Properties data (3 copies) as outlined in the transmittal document Ifyou have any questions about this submission please contact the undersigned at (302) 234-2780 or catherine@wagnerreg.com. Respectfully submitted,

Catherine M. Byrd Agent for RedEagle International LLC Enclosures 

### • 

## • • 

## • 

## ,

, 

## "

, 

## , , , C c 'c



## , , , , , c, 

### ,

### August I, 2009

To Whom It May Concern Dear Sir or Madam: Phone: (863) 682-6698 Fax: (863) 682-6690



### This letter serves as notification that RedEagle International LLC. has appointed Wagner Regulatory Associates, Inc. (WRA, Inc.) to serve as the Agent on our company's behalf regarding all state and federal regulatory matters relative to products that RedEagle 

### International LLC. 

## will register with the U.S. EPA and the states. Please forward all correspondence for RedEagie International LLC. and its products to; Wagner Regulatory Associates, Inc. P.O. Bo<640 

### Hockessin, DE 19707-0640 Thank you for your time and assistance. Please feel free to call me if

### you have any questions. Respectfully submitted.



### Yingxue Yu ChiefExecutive Officer
cc: 

### WRA, Inc.

Address: 1925 E. Edgewood Drive, Lakeland, Florida 33803

### 1.

2.



### 3.



### 4. 

### MRID 

### 48179804 DATA TRANSMITIAL DOCUMENT Name and Address of Submitter RedEagle International LLC c/o Wagner Regulatory Associates PO Box 640 

### Hockessin, DE 19707 Regulatory Action In support OfWhich This Package Is Submitted Application for Registration Tribufos Technical EPA File Symbol**85678~RN** Transmittal Date January 25,2011 List of Submitted Studies**~Vol.--E--** 

## Sun,-O;ng(20iOf**Tribuf~sTeCi1~ical'Gr~de** Active Ingredient Physical 

## aii(iChemical Characteristics. Southwest Research Institute, San Antonio, Texas. Report Number 01.14990.02.002. 16 pages.
Company Official:

Company Name: Company Contact: Catherine M. Byrd 

### Name Wagner Regulatory Associates, Inc. Agent for RedEagle International LLC
Catherine M. Byrd 

### Name Signature

(302) 234·2780 Phone



### , , ., " '" 

### , 

## , " ; ) 

### , ,



### , 'J ,;,

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

Office ofChemical 

### Safety and Pollution Prevention 

### January 24, 2011 

### MEMORANDUM Subject: Name ofPesticide 

### Product EPA File Symbol: DP Barcode: DecisionNo.: Action Code: PC Code: 

### Tribufos Technical 85678-RN D382144 438264 R310 

### 074801 Tribuphos From: 

### Breann Hanson, Biologist 

# R**~.rv?.:;;....r,,­** Technical Review Branch 

# &R'8{ '"-,,, Registration Division (RD; 7505P) 

### To:
Applicant 

### Hope Johnson, RMTeam 25 Herbicide Branch Registration Division (7505P) RedEagJe International LLC 

### clo Wagner Regulatory Associates, Inc. PO Box 640 Hockessin, DE 19707 

### FORMULATION FROM LABEL: Active Ingredient: 

### 074801 Tribufos CAS No. 78-48-8 

### %bywt 99.5 

### Other Ingredients: 0.5 Total: 100.0%

### PC Code: 074801 EPA File Symbol: 85678-Rt'l ACTION REQUESTED: The Risk Manager requests: "The registrant has submitted a new technical tribufos application with the source from china. They are citing the acute tox studies in support ofthis application. They state they are substantially similar to 264-720. Please review substantial similarity claim and citations for acceptance. Thanks". BACKGROUND: RedEagle International LLC (herein the "registrant") has submitted an application for registration ofTribufos Technical Technical, EPA File Symbol: 85678-RN, claiming substantial similarity to 

### DEF Technical Defoliant, EPA Reg. No. 5481-9022. The productwas originally registered under EPA Reg. No. 3125-96, transferred to EPA Reg. No. 264-720, and has recently been transferred to EPA Reg. No. 5481-9022. Both the cited and proposed products are technical grade products for use in manufacturing cotton defoliants. The acute inhalation toxicity study (MRID4178230 1) submitted to support registration ofthe cited product was previously reviewed by the Registration Support Branch (RSB; 

### I. Blackwell; EPA Reg. No. 3125-96; 511411992) and graded as guideline data. The acute oral (MRID 41954903) and acute dermal (MRID 41954902) studies submitted to support registration ofthe cited product were subsequently reviewed by RSB (M. Perry; EPA Reg. No. 3125-96; 4/211993) 

### and graded as guideline data. The dermal irritation (MRID 41896303) and dermal sensitization studies (MRID 41618812) were reviewed by Health Effects Division (HED; R. Zendzian; Registration #: 07480I, 3/1/1993) 

### and graded as guideline data. An eye irritation study (MRID 42441601) was later submitted and reviewed by HED (R. Zendzian; DP Barcode: D273886, 51112001). 

### COMMENTS AND RECOMMENDATIONS: I. TRB has evaluated the proposed basic CSF (dated 8/6/2010) 

### and the cited basic CSF (dated 1/30/2009) 

### and has determined that they are substantially similar in toxicity. In addition, the cited and proposed product labels are substantially similar in labeling ofuse sites. The acute toxicity data reviewed for registration of 5481-9022 can be bridged to 85678-RN. 2. The acute toxicity proftle for Tribufos Technical, EPA File Symbol: 85678-RN, is as follows: Acute oral toxicity Acute dermal toxicity Acute inhalation toxicity Acute eye irritation Primary skin irritation Dermal sensitization II Cited II Cited III Cited IV Cited III Cited Negative Cited MRID 41954903/EPA 

### Reg. No. 5481-9022 MRID 41954902IEPA 

### Reg. No. 5481-9022 MRID 417823011EPA Reg. No. 5481-9022' MRID 42441601IEPA Reg. No. 5481-9022 MRID 41896303IEPA Reg. No. 5481-9022 MRID 41618812IEPA Reg. No. 5481-9022 *The accepted label ofthe cited product 5481-9022 does not contain category III precautionary statement acute inhalation labeling, which includes the statements "Harmful ifinhaled. Avoid breathing [spray mist]". 

### In addition, the category II dermal toxicity labeling statement "Do not get on skin" is not included. This reviewer cannot determine from available information whythis language has been omitted from the label of5481-9022. Since the proposed product is substantially similar to the cited product, 85678-RN is also not required to contain these missing labeling statements.

Page 2 of3

### PC Code: 074801 EPA File Symbol: 85678-RN 3. Based on the toxicity profile above, the following are the precautionary and first aid statements for this product as obtainedfrom the Label Review System: PRODUCT ID 

### #: 085678-00010 PRODUCT NAME: Tribufos Technical PRECAUTIONARY STATEMENTS SIGNAL WORD: WARNING Hazards to Humans and Domestic Animals: May be fatal ifabsorbed through skin. May be fatal ifswallowed. Harmfol ifinhaled. Do not get in eyes, on skin, or on clothing. Wash thoroughly with soap and water after handling and before eating, drinking, chewing gum, using tobacco orusing the toilet. Remove and wash contaminated clothing before reuse. Avoidbreathingspray mist. 

### * First Aid: Ifon skin: -Take offcontaminated clothing. -Rinse skin immediately with plenty ofwater for 15-20 minutes. -Call a poison control center or doctor for treatment advice. Ifswallowed: -Call a poison control center or doctor immediately for treatment advice. -Have person sip a glass ofwater ifable to swallow. -Do not induce vomiting unless told to by a poison control center or doctor. -Do not give anything to an unconscious person. Ifinhaled: -Move the person to fresh air. -Ifperson is not breathing, call 911 or an ambulance, then give artificial respiration, preferably mouth-to-mouth if possible. -Call a poison control center or doctor for further treatment advice. Have the product container or label with you when calling a poison control center or doctor orgoing for treatment. You may also contact 1-800-xxx-xxxx for emergency medical treatment information. *Statements 

### in italics 

### are not required based on the accepted label ofthe cited product 5481-9022. 

### 4. NOTE 

### TO Rl"1: The proposed and cited product labels are substantially similar in precautionary and first 

### aid statements. 5. The basic 

### CSF for the proposed product must be approved 

### by the TRB Product Chemistry Team.

Page 3 of3BARCODE: 0382143; Reg. No. IFILE SYMBOL No.: 85678-RN- PRODUCT: Tribufos Teclmical
DATE: SUBJECT: FROM:


### TO: November 22, 2010 Product Chemistry Review ofTribufos Technical 

### Akiva Abramovitch, Ph.D. 

# J Technical Review Branch I 

### RD (7505P) 

# Y Hope Johnson, Team Reviewer IKable Davis, Risk Manager, RM 25 Herbicide Branch I 

### RD (7505P) DP BARCODE: D382143 DECISION No.: 438264 Registration Number/ File Symbol No.: 85678-RN PRODUCT NAME: Tribufos Teclmical PCC: 074801 REGISTRANT: RedEagle International LLC USE: Defoliant FOOD USE: Yes [ ] No [X] MRID Numbers: 481798-01 through 481798-04
INTRODUCTION: Tribufos Technical (S,S,S,-tributyl phosphorotrithioate) is a teclmical grade active ingredient proposed for registration as a technical product for fonnulation use in the manufacture ofcotton defoliants. Group A and Group B data were submitted for the TGAI. The registrant cited product EPA Reg. No. 264-720 (Now 5481- 9022) as a "me-too" product. The preliminary review ofthe data was conducted by Oak Ridge Laboratories. SUMMARY OF FINDINGS: I. The registrant has submitted a Confidential Statement ofFonnula for a basic formulation dated January 26, 2011 (previously dated August 6, 2010) ofTribufos Teclmical. The product chemistry data submitted corresponding to guideline reference 830.1550 (product identity & composition) satisfy the data requirements of 40CFR§ 158.155 [CSF and MRID No. 481798-02]. 2. The product chemistry data submitted corresponding to guideline reference 830.1600 (description ofmaterial used to produce the product) satisfy the data requirements of40CFR§ 158.160 [MRIO No.481798-02]. 3. The product chemistry data submitted corresponding to guideline reference 830.1620 (description ofproduction process) satisty the data requirements for 40CFR§158.162 [MRIO No.481798-02]. 4. The product chemistry data submitted corresponding to guideline reference 830.1670 (discussion on the fonnation ofimpurities) satisty the data requirements for 40CFR§ 158.167 [MRlO No. 481798-02]. 5. The data submitted corresponding to gUideline reference 830.1700 (preliminary analysis) satisfy the data requirements of40CFR§ 158.170 [MRID No. 481798-03]. 6. The data submitted corresponding to guideline reference 830.1800 (enforcement analytical method) satisty the data requirements of40CFR§158.180 [MRIO No. 481798-03]. 7. The data submitted corresponding to gUidelines 830 Series Subgroup B (physical-chemical properties) satisty the data requirements of40CFR§ 158.190 for color, physical state, odor, stability, pH, density, UV/visible absorption, partition coefficient, water solubility and vapor pressure [MRIO No. 481798-04]. Information onBARCODE: D382143; Reg. No. /FILE SYMBOL No.: 85678-RN- PRODUCT: Red EagleTribufos Technical absorption, partition coefficient, water solubility and vapor pressure [MRID No. 481798-04]. Information on boiling point needs also to be presented in the format recommended in OPPTS 830.7220 (in degrees Kelvin and corrected to standard pressure). Tribufos Technical is a liquid; therefore, the data for melting point (830.7200) is not required. Tribufos Technical is not an end-use product; therefore, data for dielectric breakdown voltage (830.6321) are not required, and because it is not an emulsifiable liquid to be diluted with a petroleum solvent, data on miscibility are not required. The submitter (MRlD 481798-01) has requested data waivers for the requirements ofoxidation/reduction (identified as an oxidizing agent and so indicated on the label), flammability (reported that the TGAI does not contain combustible liquids), and explodability (reported to not have the potential to explode). CONCLUSIONS: I. The product chemistry data submitted for guideline 830 Series Group A are acceptable with the revised CSF dated January 25, 2010. The nominal concentrations and upper certified limits for two ofthe impurities are consistent with the preliminary analysis ofthe batches with the lower % ofthe active ingredient and thus the higher % ofimpurities. 2. Data submitted for color, physical state, odor, stability, pH, density, UV/visible absorption, partition coefficient, water solubility, viscosity and vapor pressure are acceptable. The BP should also be reported (be corrected) to standard pressure (101.325 kPa). 3. The submitter has requested data waivers for the requirements ofoxidation/reduction, flammability, and explodability (MRlD 481798-0 I). 4. The submitter does not consider the data requirements for storage stability and corrosion characteristics as applicable to the TGAI; however, because the TGAI is also a MP these data are required as a condition to the registration ofthis product. 5. This product is substantially similar to product EPA Reg. No. 5481-9022 DEF Technical Defoliant by AMVAC Chemical Corporation (Was 264-720). However, there are differences between the two products that must be noted as follows: a) Name: Tribufos vs Tribuphos under 07480 I b) 99.5% vs 97.9% for the active ingredient in the "me-too" product (within the 3% certified limits) c) No Tribufos isomers reported for this product but were reported for the me-too product. The registrant confirmed that these isomers are not present in their product. That may also explain the higher percentage of 'active ingredient reported as 99.5% on both the CSF and the label ofthis product. d) A small amount of was listed on the CSF and not listed on the "me-too" product. The impurity is attributed to the presence of as impurity in the ingredient used in the process. However, since this impurity is similar in structure to Terbufos, it should not cause additional toxicological concern

### BARCODE: D382143; Reg. No. !FILE SYMBOL No.: 85678*RN* PRODUCT: Tribufos Technical
830.1550. Product identity & 

### Composition: (MRID No.481798*02) Common Name: Tribufos Chemical name (CAS): S,S,S,*Tributyl phosphorotrithioate (lUPAC): S,S,S,*Tributyl phosphorotrithioate CAS No.: 78A8*8 

### PC Code No.: 074801 Empirical formula: C12H270PS3 Molecular Weight: 314.5 Structural formula:

I I

# ~ p 

### H,C(CH.),sj
....S(CH,l,CH, S(CH,),CH,

I

.

f process

, I

I A A A A

A

A i iI 

## " 

# "

nominal coneentration (95.52%) and the preliminary analysis for the impurities. The high certified limits for the impurities is based on the batehes with the
were gap; progress orBARCODE: 0382143; Reg. No./FILE SYMBOL No. : 85678-RN- PRODUCT: Tribufos Technical
830 Series Subgroup B (Physical-Chemical Properties) Tnble 2: Ph sical and Chemical Pro erties ofTribufos technical GLN Requirement MRID Status Resultor Deficiency 830.6302 Color 481798·04 A Clear colorless 830.6303 Phvsical state 481798·04 A Liouid 830.6304 Odor 481798-04 A Mercaptan-like smetl 830.6313 Stability to nonnal and 481798-04 A Stable under all conditions except in the presence of elevated temperatures, ferric**~s~~tate** (TOAI purity 86.71 % ofinitial value after metals, and metal ions 14 davs. 830.6314 Oxidationlreduction: chemical**inco~natibilitv** 481798-01 W Submitter requests a data waiver because TOAI is known to be a';;otential oxidizer which is indicated on the label. 830.6315 Flammability 481798-01 W Submitter states that the TOAI does not contain combustibte liquids; therefore, a data waiver is requested. 830.6316 Explodability 481798-01 W Submitterstates that TOAI does not have Ihe potential to exnlode; therefure, a data waiver is renuested. 830.6317 Storage stability 481798-01 G Submitter states that because Tribufos Technical is a TOAI these data arc not required. Since the TOAI is also an MP, this is a data gap. 830.6319 Miscibility 481798-01 A Submitter states that TOAI is not an emulsifiable liquid to be diluted with petroleum solvents; thereforc, these data are not required. 830.6320 Corrosion characteristics 481798-01 G Submitter states that Tribfos Tecnhical is a TOAI; therefore, these dato are not reqllired. Since the TOAI is also an MP, this is a data gap. 830.7000 pH 481798·04 A 3.7 830.7050 UV/Visible absorption 481798-04 A Wavelength; molar absorption coefficient: Acidic pH:233 nm; e"" 1070 207 nm; e"" 1390 Neutral pH 7: Not reported Alkaline pH: 2t2nm;e"" 18830
830.7100 Viscosity 481798-04 A 10.89 centistokes at25 C and 6. t9 at45C 830.7200 Meltin oint 48t798-01 NtA Substance is a liquid 830.7220 Boiling point 481798-04 A 166"C at 0.6 mm Hg. The boiling point should also be corrected to standard nressure 830.7300 Densit 481798-04 A 1.064 g/cm3 at 21"C 830.7370 Dissociation constants in W No data presented water (DC) 830.7550 Partition coefficient 481798-04 A 3.23**~~~f)'** Data from published source (pesticide Manual 830.7840 Water solubility: 481798-04 A 2.3 mgIL at20"C Data from published source (Pesticide Manual) 830.7950 Vapor pressure 481798-04 A 0.32 mPa at 20"C; 0.71 mPa at 25"C. Data from ublished source (pesticide Manual A = Acceptable; N = unacceptablc (see Deficiency); N/A"" Not Applicabte; 0 "" Data gap; I

- In progress or need upgrade; U '" Up-grade (additional infonnation required); W "" waiversBARCODE: D382143; Reg. No./FILE SYMBOL No.: 85678-RN- PRODUCT: Tribufos Technical
830.1800. Enforcement analytical method (MRlD 481798-03): The submitter incorporated the documentation ofthe Enforcement Analytical Method into the same MRlD (481798- 

### 03) containing the Preliminary Analysis data. The procedures, materials, instrument parameters, and calculations described below may be used for verification ofthe certified limits for technical grade tribufos. 1. INTRODUCTION The objective ofthis study was to detenlline the pUrity oftribufos tedmiclII grade active ingredient (TGAI), The study was conducted in accordance with the study protocol, USEPA Pesticide Assessmeltt Guidelines Stlbdivislon-D, OPPTS 830,1700 and 830.1800; USEPA Good Laboratory Practices (40 CFR Part 160); and Southwest Research Institute (SwRl)**~t.andard** Operaling Procedures to quantitate tribufos and dete<:ted impurities present above 0.10/0). SwRI served as acontract labomtory for the sponsor. 

### n. TEST AND REFERENCE SUBSTANCES A. Test Substances, provided by the spllnsor and list in SwRl Task Order #100405-4. Conunon Name: IUPAC: Empirical Fonnula: Molecular Weisht: CAS#: Tribufos S,S,S-Tributyl phosphorotrithioate**CI~H2PPS2** 314.5 (78-48-8] 1. Trlbufos #20to0326-1# 2. Tribufo5 #20100326-2# 3. Tribufos #20to0326-3# 4. Tribuf08 #20100326-4# 5. Tribufos#20100326-5# B, Reference S\lbstance Tribufos, CAS # 7g·4S-8 Supply: Chern Service Purity: 97.5 % Lot# :428-50B Bxpiration Date: 07nOIl Tribufbs, CAS II 78-48-8 Supply: Ultra-Scienlific Purity: 97.8 %

### BARCODE: D382l43; Reg. No. IFILE SYMBOL No. : 85678-RN- PRODUCT: Tribufos Technical

Lot # :N"T00695 Expiration Date: 01/2012 

## m. STUDY PERSONNEL Gnng Sun, Ph.D., study director and project manager Michelle Ztmiga, senior research scientist John Eric Gomez, technician Monica Mendoza, research assistant IV. 

### EXPERIMENTAL Tribufos purity analysis was perfonned according to SwRITAP 01-0408-095 Preliminary AI/alytlcalMeti/od/o/"PesticideProducts by GCIFID ond GC/MS, The method was validated for precision and accuracy of preliminary analysis. Particular details of thc anatytical method for tribufos TOAI are given below. A, Sample Preparation The sample stock solutions were prepared in duplicates at approximately lmglmL in methylene chloride. Thesampleswerediluted IOO-fold with methylenechlorideforpurity analysis. B. 

### Analytical Method The analysis was performed on an Agilent 6890 GC equipped with a Flame Ionization Detetltor(FlO). The system was equipped with aDB-5MS 30 mx 0,25 mm x 0.25 um capillary column. TIle injector temperature was 250 'C. The oven program was 40'C for 1.0 minutes then IO'Cimin to 310'C hold for 5 minutes, The following flow rates were used for the FID: Detector Temp: 300 'C;H: Flow: 30mUmtn; Air

### Flow: 400 mUmin;Makeup GasType: Nitrogen;N:Flow: 30 mUmin; Mode: Constant column 

### +makeup C. Quantitation, Calculations and StatisticalMethods Bacb samplewas spikedwithsemi-volatileinternal standard at5ugfmL final concentration, A lineal'curve was llsed for the calculationofthe tribufos, The Rl for lhe tribufus was greater than 0.995, Chemstation only lists theXVariable 1and Intereeptat 3significant figures so thestatislical regression for tribufos was generated to show the actual values oftheX Vllriable I and Interceptfor calculation purposes,

### BARCODE: 

### D382143; Reg. No. /FILE SYMBOL 

### No.: 85678-RN- PRODUCT: 

### Tribufos Technical
Precision oftlle analytical method was detennined by analyzing seven replicate injections ofsnmple solutions prepared from a tribufos sample. TIle mean (X), 

### standard deviation (8) and coefficient ofvllriation (CV) 

### were then ca!culated for allalyte over the seven replicate analyses. EXi X"" -----.---------- , N 

## s = {_

..

## _~_(~~:.?2~_. 

# } If2, N" I 

### S 

### CV = """""""" 

### 100% X 

### where Xi represent the individual values for a set ofN replicate measurements (N=7). 

### Accuracy oftheanalytical method was demonstrated by analysis ofa five-point calibration CliVC, The percent deviation ofthe calculated amount, based on the five-point linear regression curve, from the theoretical amount was calculated for tribufos for the five-point calibration CUITe, Calc Amt

- Thea Amt %

### Deviation = --.-------______•_______.________ 

### x 100 % 

### TheoAmt where Calc Amtis thecalculatedconcentration baseuponthe IinearregressioncUlVc, andThea Amt is the theoretical concentmtlon ofthe standard.

Y. PROCEDURALMODIFICATION AND NOTICE 

### Two amendments but no studydeviation wererecordcd during the conduct ofthe study for replacing 5-batch testing samples, modifying proposed completion date, lind adding more analysts to theproject. Additional items as specified in 40 CPR 160. 185.a.(7, 8) are not applicable to this study.

VI. RESULTS AND DISCUSSION A. Va1idation ofthe Analytical Method A validation study was perfonncd to detennille the precision ofthe analytical method for tribufos purity, Tribufos TOAI batch #20100326.5# sample testing solution Was prepared, then aualyzedin sevenreplicatesbyGC/FID, Themean, standarddeviation andcoefficientofthetesting results were thcll calculated. Thcseresults are presented in Table 1.BARCODE: D382143; Reg. No. !FILE SYMBOL No.: 85678-RN- PRODUCT: Tribufos Technical Unerity: A linear calibration curve was used for the calculation oftribufos (Figure I). The Rl for the tribufos curve was greater than 0.995. All continuitlg calibration checking results were achieved at less than or equal to a 2% ofthe theoretical value. Limit of Quantification: The lowest point in calibration curve is used as method reporting limit (MRL)here equivalent to about $0% for limit ofquantitation (LOQ). Appropriate calculations used in the quantitation oftrihufos is provided on SwRJ TAP 01-0408-095. Selectivity/Specificity: As shown in chromatography, there is no interference for tribufos peak identification and quantification. The 

### GCIFID chromatography are identical inboth mbufos analytical s.tandard and in five lots oftrlbufos technical samples, and confirms the identity ofthe active ingredient. B. Tribufos TOArPurityResults Purity analysis was performedon five lots oftribufosTOA!, These results arepresented in Tablc2. Thepercentpurity oftribufoswas comparablefor the five 10tsTOAI samples. Theaverage purity for these five lots tribufos TOAlwas 100.21 

### %.


### VU. CONCLUSIONS The Analytical method presented here is precise and accurate for the determination ofpurity oftribufos TOAl. Preliminary-analysis oftile five lots oftribufos TGAl indicates that the average purity is 100.21 %. VIII, DISPOSITION OF RAW DATA AND SAMPLES All raw data, chl'omatograms, spreadsheets and notebooks wiU"be maintained for a period ofat least 

### Syears following the date on which the results oftile studyare submitted to theBPA in supportofan.application for 

### a research or marketing pelmit. Unused samples will be sent back to the sponsorormaintained for a period ofat least 5 years foUowing the date on which the results of the study are submitted to the EPA in support ofan application for 

### a research or marketing pennit. IX. REFERENCES USEPA, Pesticide Assessment Guidplines SubdivisionD, 40 CFR 158, ProdllctChemistry USEPA, pesticide Assessment

### Ould~lines OPPTS 830 Series, Product Chemistry 

### !BARCODE: D382143; Reg. No. /FILE SYMBOL No. : 85678-RN- PRODUCT: Tribufos Technical

X. TABLES AND FIGURES


### Table**1~1.** 

### Method Validation for Precision ofTribufos Analysis (Sample ill Lot # 20100326.5#)
ANALYTE Replicate

### # Purity

100.03% 2 101.17% 3 100,07% Tribufos 4 99.99 % 5 100,31 

### % 6 100.22 % 7 100.00% Mean (X)

100,26 % Standard Deviation (S)

0.42 % pm;ision [CV:::(SIX) 100%)

0.42%



### Table 1-2. Method Validation for Accuracy ofTribufos Analysis
Tribufos Std.

STD 1 STD2 

### STD3 STD. STD5 Theoretical Amt**(ngf~L)** 5,170 7,775 10.340 12,925 15.510 Calculated Amt 

### % Deviation**(ngf~L)** 5.186 0.31 

### % 7,792 0.48 

### % 10,272 -0,66% 12,889 ·0,28 

### % 15.562 0,34% Average %deviation

0,038%

## Pages 30
-37
-* Manufacturing process information may be entitled to confidential treatment*

### DATA EVALUATION RECORD 

### S,S,S,-Tributyl phosphorotrithioate (Tribufos Technical) STUDY TYPES: Product Identity and Composition (OPPTS 830.1550)

Primary Reviewer: 

### Description ofMaterials Used to Produce the Product (OPPTS 830.1600) Description ofthe Formulation Process (OPPTS 830.1650) Discussion ofFormation ofImpurities (OPPTS 830.1670) Preliminary Analysis (OPPTS 830.1700) Certified Limits (OPPTS 830.1750) Enforcement Analytical Method (OPPTS 830.1800) Physical and Chemical Characteristics (OPPTS 830.6302-830.7950) MRIDs 481798-01 through 4817911-04 Prepared for 

### Registration Division Office ofPesticide Programs U.S. Environmental Protection Agency One Potomac Yard 2777 South Crystal Drive



### Arlington, VA 22202 Prepared by Toxicology and Hazard Assessment Group Environmental Sciences Division

Oak Ridge National Laboratory 

### Oak Ridge, TN 37831

Task OrderNo. 1-26

Dennis M. Opresko, Ph.D. Secondary Reviewers: Sylvia Milanez, Ph.D., D.AB.T.
RobertH. Ross, M,S., Group Leader Signature: Date: Quality Assurance: Lee Ann Wilson, M.A. Signature: Date:

Disclaimer This review may have been altered subsequent to the contractor's signatures above.
Oak Ridge National Laboratory managed and operated by UT-Battelle, LLC., for the U.S. Department ofEnergy under ContractNo. DE-AC05-000R22725,BARCODE: D382143; Reg. No. /FILE SYMBOL No. :**85678~RN~** PRODUCT: Tribufos Technical
DATE: SUBJECT:

TO: November 22,2010 Product Chemistry Review ofTribufos Technical

Name ofthe Team Reviewer / Name ofRisk Manager, RM 0 Insecticide Branch / RD (7505P) DP BARCODE: D382143 DECISION No.: 438264 Registration Number/ File Symbol No.:**85678~RN~** PRODUCT NAME: Tribufos Technical PCe: 074801 REGISTRANT: Redeagle International LLC USE: Defoliant FOOD USE: Yee [ 

## 1 No [Xl MRID Numbers:**481798~Ol** through**481798~04** INTRODUCTION: Tribufos Technical**(S,S,S,~tributyl** phosphorotrithioate) is a technical grade active ingredient proposed for registration as a technicalproduct for formulation use in the manufacture ofcotton defoliants. Group A and Group B data were submitted for the TGAI. SUMMARY OF FINDINGS: 1. The registrant has submitted a Confidential Statement ofFonnula for a basic formulation (dated August 6, 2010) ofTribufos Technical. The product chemistry data submitted corresponding to guideline reference 830.1550 (product identity & composition) do not satisfy the data requirements of40CFR§158.155 [CSF and MRID No.**481798~02].** The following need to be corrected: (a) the nominal concentration ofthe a.i. on the CSF and on the label need to match exactly; both should be 99.52% and the other ingredients should total 0.48%; (b) the upper certified limits and the nominal concentrations ofthe impurities and (CSF) are inconsistent with the preliminary analysis (MRID**481798~03)** and these discrepancies must be resolved; (c) the lower certified limits ofthe impurities must be removed from the CSF; (d) the purity ofthe TGAI (99.5%) should be removed from colunm lOonthe CSF; and (d) the spelling ofthe impurities should be corrected. 2. The product chemistry data submitted corresponding to guideline reference 830.1600 (description ofmaterial used to produce the product) satisfy the data requirements of40CFR§ 158.160 [MRlD**No.481798~02].** 3. The product chemistry data submitted corresponding to guideline reference 830.1620 (description ofproduction process) satisfy the data requirements for 40CFR§ 158.162 [MRlD**No.481798~02].** 4. The product chemistry data submitted corresponding to guideline reference 830.1670 (discussion on the fonnation ofimpurities) satisfy the data requirements for40CFR§ 158.167 [MRID No. 481798·02]. 5. The data submitted corresponding to guideline reference 830.1700 (preliminary analysis) satisfy the data requirements of40CFR§158.170 [MR1D No. 481798·03].


### 2BARCODE: D382143; Reg. No.IFILE SYMBOL No.: 85678-RN- PRODUCT: Tribufos Technical
6. The data submitted correspondingto guideline reference 830.1800 (enforcement analytical method) satisfy the data requirements of40CFR§158.180 (MRID No. 481798-03]. 7. The data submitted corresponding to guidelines 830 Series Subgroup B (physical-chemical properties) satisfy the data requirements of40CFR§158.190 for color, physical state, odor, stability, pH, density, UV/visible absorption, partition coefficient, water solubility and vaporpressure [MRID No. 481798-04]. Infonnation on boiling point needs to 

### be presented in the fonnat recommended in OPPTS 830.7220 (in degrees Kelvin and corrected to standard pressure). Tribufos Technical is a liquid; therefore, the data for melting point (830.7200) is not required. Tribufos Technical is not an end-use product; therefore, data for dielectric breakdown voltage (830.6321) are not required, and because it is not an emulsifiable liquid to be diluted with a petroleum solvent, data on miscibility are not required. The submitter

### CMRID 481798-0I) has requested data waivers forthe requirements ofoxidationlreduction (identified as an oxidizing agent and so indicated onthe label), flammability (reported that the TGAI does not contain combustible liquids), and explodability (reported to not have the potential to explode). The submitter states that because Tribufos Technical is a TGAI, the data requirements for storage stability and corrosion characteristics are not required; however, because the TGAI is also an MP these data are required. 8. No data were submitted for the endpoint ofviscosity (830.7100) or for dissociation constant (830.7370); these must be addressed. CONCLUSIONS: 

### 1. The product chemistry data submitted for guideline 830 Series Group A are not acceptable because the nominal concentration ofthe a.i. on the CSF is not exactly equal to the concentration onthe label, and because the nominal concentrations and upper certified limits for two ofthe impurities are inconsistent with the preliminary analysis. 2. Data submitted for color, physical state, odor, stability, pH, density, UVIvisible absorption, partition coefficient, water solubility and vapor pressure are acceptable. As per OPPTS 830.7220, the boiling point (BP) needs to be expressed in OK, the pressure inkPA and the BP should be corrected to standard pressure (101.325 kPa). 3. The submitter has requested data waivers forthe requirements ofoxidation/reduction, flammability, and explodability (MRlD 481798-0I). 4. The submitter does not consider the data requirements for storage stability and corrosion characteristics as applicable to the TGAI; however, because the TGAI is also a MP these data are required. 5. The submitter needs to provide ajustification for not submitting data for viscosity and dissociation constant (830.7370). 6. Test methods for several physical and chemical characteristics (i.e., boiling point, pH) are identified only as SwRi TAP methods; and it is unclear ifthese are equivalent to those recommended inthe OPPTS guidelines. The submitter needs to verifY that these methods are equivalent to OPPTS recommended methods.

3

### BARCODE: D382143; Reg. No./FILE SYMBOL No.: 85678-RN- PRODUCT: Tribufos Technical
830.1550. Product identity & 

### Composition: (MRID No.481798-02) Common Name: Tribufos Chemical name (CAS): S,S,S,-Trihutyl phosphorotrithioate (IUPAC): 

### S,S,S,-Tributyl phosphorotrithioate CAS No.: 78-48-8 PC Code No.: 074801 Empirical formula: Ct2

### HnOPS3 

### Molecular Weight: 314.5 Structural formula:

Table I.Manufacturin and 1m GLN Requirement MRID 830.t550 Product Identity and composition 481798-02

8301600 Description ofmaterials used to 481798-02 produce the product 830.1620 Description ofproduction process 481798-02 830.1670 Discussion offonnation of 481798·02 impurities 830.1700 Preliminary analysis 481798·03
830.1750 Certified limits CSF

830.1800 Enforcement analytical method 481798-03 uri Data for Trlbufos Tecbnicat Status Details and for Deficiency The nominal concentration ofthe a.i.1isted in column 13 ofthe CSF (99.52%) does not exactly match the label concentration (99.5%). The "purity "ofthe TGA11isted in column 10 ofthe CSF N (99.5%) should be removed. An appropriate justification is needed for the nominal concentration and upper certified limits ofthe impurities, and the listed lower certified limits of the impurities should be removed from the CSF. A Starting materials were adequately described. A The product is produced by a that was adeauatel described. A A discussion ofthe fonnation ofthe impurities was 

### i Novided.

Results ofthe 5·batch analysis were consistent with A the proposed nominal concentration and certified limits ofthe a.i., but not for two ofthe impurities. Certified limits for the TGAI were based on the nominal concentration (95.52%) and the recommended range of±3%. The nominal N concentrations ofthe impurities listed on the CSF were inconsistent with the preliminary analysis for the impurities. The lower certified limits for the impurities should be removed from the CSF. A GCfFlD and GCJMS were used in the analysis of Tribufos Technical A Acceptable; N unacceptable (see Deficiency); NfA Not Applicable; G Data gap; I In progress or need upgrade; U Up-grade (additional infonnation required

4

### BARCODE: D382143; Reg. No. !FILE SYMBOL No.:**85678~RN~** 

### PRODUCT: Tribufos Technical
830 Series Subgroup B**(physical~Chemical** 

### Properties)
Table**2~** Ph sical and Chemical Pro ertiesofTribufos technical GLN Requirement MRlD Status Resultor Deficiency 830.6302 Color 481798·04 A Clear colorless 830.6303 Physical state 481798·04 A Li uid 830.6304 Odor 481798-04 A Mercaptan·like smell 830.6313 Stability to normal and 481798-04 A Stable under all conditions except in the presence of eleyated temperatures, ferric acetate (TGAl purity 86.71% ofinitial value after metals, and metal ions 14 days). 830.6314 Oxidation/reduction: 481798-01 W Submitter requests a data waiver because TGAI is known chemical incompatibility to be a otential oxidizer which is indicated on the label. 830.6315 Flammability 481798-01 W Submitter states that the TGAl does not contain combustible liquids; therefore, a data waiver isrequested. 830.6316 ExplCKlability 481798-01 W Submitter states that TGAI does not have the potential to exolode; therefore, a data waiver is reQUested. 830.6317 Storage stability 481798-01 G Submitter states that because Tribufos Technical is a TGA! these data are not required. Since the TGAl is also an MP, this is a datagap. 830.6319 Miscibility 481798-01 A Submitter states that TGAI is not an emulsifiable liquid to bc diluted with petrolewn solvents; therefore, these data are not required, 830.6320 Corrosion characteristics 481798-01 G Submitter states that Tribfos Tecnhical is a rGAl; therefore, these data are notrequired. Since the TGAI is also an MP, this is a data gap. 830.7000 pH 481798-04 A 3.7 830.7050 Uvrvisible absorption 481798-04 A Wayelength; molar absorption coefficient Acidic pH:233 nm',**~** = 1070 207 nm; e"" 1390 Ncutral pH7: Not reported Alkaline pH: 212nm;e=18830
830.7100 Viscosity G No data presented 830.7200 Meltin**~** ooint 481798-01 NIA Substance is a liquid 830.7220 Boilingpoint 481798-04 A 166°C at 0.6 mm Hg. Theboiling point should be given in de"rees Kelvin and corrected to standard pressure 830.7300 Density 481798-04 A 1.064 cm3 at21°C 830.7370 Dissociation constants in G No data presented water (DC) 830.7550 Partition coefficient 481798"04 A 3.23 (log). Data from published source (pesticide Manual) 830.7840 Water solubility: 481798-04 A 2.3 mgIL at 20°C Data from published source (Pesticide Manual) 830.7950 Vapor pressure 481798"04 A 0.32 mPa at 20QC; 0,71 mPa at 25 QC, Datafrom published source (Pesticide Manual) A"" Acceptable; N "" unacceptable (see Deficiency); N/A = Not Applicable; G = Data gap; I = In progress orneed upgrade; U = Up-grade (additional information required); W "" waivers

5BARCODE: D382143; Reg. No.IFILE SYMBOL No.: 85678-RN- PRODUCT: Tribufos Technical
830.1800. Enforcement analytical method (MRID 481798·03): The submitter incorporated the documentation oftheEnforcement Analytical Method into the same MRID (481798- 03) containing the Preliminary Analysis data. The procedures, materials, instrument parameters, and calculations described below may be used for verification ofthe certifIed limits for technical grade tribufos. 1. INTRODUCTION The objective ofthis study W35 to detennine the purity oftribufos technical grade active ingredient (TGAI). The study was conducted in a<:<:ordancc with the study protocol, USBPA Pesticide Assessment Guldclinea Subdivislon-D, OPPTS 830.t700 and 830.1800; USEPA Good Laboratory Praclicea (40 CPR Part 160)", artd Southwest Research buintute (SwRl) Standard Operating Procedures to quantitate tribufos: and detected impurities present above 0.1,(' SwRI served as acontract laboratory for the ;ponsor. 

### n. TEST AND REFBRENCE SUBSTANCES A. Test Substances, provided by the sponsor and list in SwRI Task Order 11100405·4. Conunon Name; ruPAC: Empirical Fonnula: MolecularWei8ht: CAS#: Tribufos S,S,S·Trihutyl phosphorolriUrioate C11HnOPSJ 314.5 [78-48.8] 1. Tribufos #20100326·1N 2. Tribufos /120100326-2# 3. Tribufos #20100326·3# 4, Tribufos #20100326-411 5. Tribufos #20100326-5# B, RererenceSub5lance Tribufos, CAS II 78·48-8 SUpply: Chern Service Purity: 97.5 % Lot 1# :428-508 Bxpiration Date: 07f2(JII Tribufos, CAS # 78-48-8 SUpply: Ultra-Scientific Purity: 97.8 %

6BARCODE: D382 143; Reg. No. /FILE SYMBOL No. : 85678-RN- PRODUCT: Tribufos Technical

Lot # :NTOO695 ExpirationDate: 01/2012 ill, STUDY PERSONNEL Gang Sun. Ph.D., study direclor and project manager Michelicl Zuniga, seniorresearch scientist John Eric Gomez, technician Monica Mendoza, research assistant 

### IV. BXPBRIMENTAL Tribufos purity analysis 

### was perfonned according to SwRITAP 01-0408-095 

### Prelimtllary Allofytical

### Method/orPesticideProducls by GC/FID and GC/MS, The method was validated for precision and accuracy ofpreliminary analysis, Particular details ofthe analytical method for tribufOll TGAI are given below. A, Sample Preparation The sample stock solutions were prepared in duplicates at approximately 1 mw'mL in methyleneehloride, The samples were diluted tOO-fold with methylenechlorlde forpurityanalysis. B. Analytical Method The analysia was perfonned on an Agilcnt 6890 GC C<{Uipped with a Flame Ionization Detector (FID), The syslem. was equipped with a

### DB-SMS 30 m x 0,25 mm x 0.25 urn capillary column, The injector temperature was 250 ·C. The ovenprogram was 4O'C for 1.0 minules then lO'C/min to 310'Chold for 5 minutes. The following flow rates were used fbr the 

### FIn: Detector Temp: 300 'C; !4Flow:30mUmin; AirFlow:400**mUmin~MakcupGas**Type: Nitrogen;N2 Flow: 30mUmin; Mode: Constant column

### +makeup C. Quantitalion, Calculations and StatisticalMethods Eacb samplewasspikedwithsemt-volatileinternal standard at

### SuglmL final concenlration. A linearcurve was used for the calculation oftho tribufos. The 

### R2 for Ihe tribufos was greaterthan 0,995. Chemstation onlyliststheXVariable t and Interceptat 3significantfigures so thestatislical regression for tribufos

### was generatedto show the actual 

### value. oftheXVariable I and interceptfor caleulation purposes. 

### I.

7

### BARCODE: D382143; Reg. No. !FILE SYMBOL No.: 85678-RN- PRODUCT: Tribufos Technical
Precision oftheanalytical method was determined by analyzing seven replicate injections ofsample solutions prepared from a tribufos sample. The mean (X). 

### standard deviation (S) 

### and coefficient ofvariation (CY) were

### then calculated for analyte over the 

### seven replicate analyses. EXi X"'" ----.---------- • N 

## s'" { ___**~J~~:_:2~** 

# __ } 1/2 • 

### N - I 

## cv ""

# ----~--- t

### 00% X 

### where Xi represent the individual values for a let ofNreplicate measurements (N=?). 

### Accuracy ofthe analytlcallnethod 

### was demonstrated by analysis ofa five-point calibration curve. The percent deviation ofthe calculated amount. bated 

### on the five-point linear regression curve, from the theoretical amount was calculated for tribufos for the five-point calibration curve, Calc Amt

- Theo Amt %

### Deviation"" -------------------.---.------" 100 % 

### TheoAmt where CalcAmtis the 

### calculatedconcentrationbaseuponthelinearregressioncurve, andTheo Amt is the theoretical concentration ofthe 

### standard.
V, PROCEDURALMODIFICATIONAND NOTiCE Two amendments but no study deviation were recorded during the conductofthestudy for replacing 5-batch testing samples, modifYing proposed completIon date, and adding more analysIs to theproject. Additional items as specified in 40 CPR 160.185,a.(7. 8) are not applicable to Ibis study.

VI. RESULTS AND DISCUSSION A, Validation ofthe Analytical Method A valIdation study was performed to detennine the precision ofthe analytical method for tribufos purity, Tribufos TOAl batch #20100326-5# sample testing solution was prepared. then analyzedin sevenreplicatesbyGCIFID, Themean. standarddeviation andcoefficientofthetesting reslilts were then calculated, Theseresults arepresented in Table I.

8

### BARCODE: D382143; 

### Reg. No.IFILE SYMBOL No.: 85678-RN- 

### PRODUCT: Tribufos Technical Linerlty! A linear calibration curve was used for tlte calculation oftribufbs (Figure I). The R2 

### fur the tribufos curve 

### was greater tlian**0.99~.** 

### All continuing calibration checking results were achieved at less than or equal to a2% ofthe theoretical value. Limit ofQuantification: The lowest point in 

### calibration curve is used as method reporting limit (MRL) here equivalent to about 

### 50% for limit ofquantitation (LOQ). Appropriate calculations used in the quantitation oftribufos is provided onSwRITAP 01-0408-095. 

### Selectivity/Specificity: As shown in 

### chromatography, there is no interference fur tribufos peak 

### identification and quantification. The GClFID chromatography arc identical in both tribuf03 analytical standard and in five lots oftribufoa technical samples, and confirms the identity ofthe active ingredient. B. Tribufos TOAl Purity

### Results Plll'ity analysis was performed on five lots oftribufosTGAI. These results are presented in Table2. Thepercentpurityoftribufoswascomparablcfurthe five 10tsTGAIsamples. Theaverage purity for these five lots tribufos TOAl was 100.21 

### 0/0.



### VII. CONCLUSIONS The Analytical methodpresented here is precise and accurate for the determination of purity oftribufosTGAI. Preliminary analysis ofthe five 

### lots oftribufos TGA! iudicates that the average purityi! 100.21 

### %. VJlI. 

### DlSPOSITION OF RAW DATA AND SAMPLES All raw data, chromatograms, spreadsheets and notebooks will be maintained for a period ofat least Syears following the date on which the results ofthe study are submitted to the EPA in supportofanapplication for a research or marketing pelll1it. Unused aamples will be sent back to the sponsorormaintainedfor a period ofat least 5years following the date on 

### whichthe rasults of the study are submitted to theEPA in support ofan application for aresearch or marketing pelll1it. 

### IX. REFERENCES USEPA, Pesticide Assessment Guidtelines SubdivisionD, 40 

### CFR 158, ProductChemistry USEPA, Pesticide Assessment

### Guid~lines OPPTS 830 

### Series, Product Chemistry I,



### 9BARCODE: D382143; Reg. No./FILE SYMBOL No.: 85678-RN- PRODUCT: Tribufos Technical



### X. TABLES AND FIGURES


### Table 1-1. Method Validation for Precision ofTribufos Analysis (Sample

## mLot

### # 20100326-5#)
ANALYTE Replica1e 

### # Purity

1 100,03 % 2 101.17 % 

### 3 100,07% Tribufos 

### 4 99.99% 5 100,31 % 6 100,22 % 7 100,00% 

### Mean (X)

100,26% Standard Deviation (8)

0.42 % Precision [CV=(S/X) 100%]

0.42%



### Table 1-2. Method Validation for AccuracyofTrlbufosAnalysis
Tribufos Std,

SIDl STD2 SID3 STD4 SID5 Theoretical Amt**("'~L)** 5.170 7.775 10,340 12.925 15.510 Calculated Amt %Deviation Average (ngfJ.LL) % deviation
5.186 0.31 % 7.792 0,48 % 10.272

- 0,66% 0.038 % 12.889 -0.28 % 15.562 0,34%

10

## Pages 48
-57
-* Manufacturing process information may be entitled to confidential treatment*

### February ll, 2011 AMVAC Chemical Corporation 4695 MacArthur Court, Suite 1250 Newport Beach, CA 92660 Wagner Regulatory Assocjates, Inc. PO Box 640 7460 Lancaster Pjke, Suite 9 Hockessin, DE 19707



### Re: Offer to Pay Compensation for Data Used to Support Pesticide Product Registration Dear Sir or Madam: RedEagle International LLC has submitted a registration application to the U.S. 

### Environmental Protection Agency ("EPA") for the manufacturing use product "RedEagle Tribufos Technical" containing tribufos as the active ingredient. In applying for this registration, RedEagle is using the 'cite all' method of data support. 

### Your company is not listed on the September 30, 2010 EPA "Data Submitters List" for tribufos active ingredient. However, we have now received EPA's written confirmation that EPA has transferred the ownership of certain tribufos data from Bayer CropScience to AMVAC. Therefore, in accordance with EPA's regulations at 40 C.F.R. Part 152.86, RedEagle hereby offers to pay reasonable compensation after the approval of its application, to the extent required by Section 3(c)(1)(F) and/or Section 3(c)(2)(B) ofthe Federal Insecticide, Fungicide and Rodenticide Act, for specific and valid data for which your company is identified by the EPA as an original data submitter and on which this application relies. RedEagle offers to begin negotiations to detennine the amount and tenns ofthe compensation, ifany, to 

### be paid for any such data. For each study for which EPA considers your company to be an original data submitter and for which you seek compensation, please identify the data items and any tenns ofcompensation that you propose. Sincerely,

James M. Wagner Agent for RedEagle International LLC Tel: 302-234-8550

### Fw: Amvac Chemical Corporation's Petition to Deny RedEagle International LLC's Application to Register Technical Tributes Meredith Laws to: Mindy Ondish, Kable Davis 02/15/2011 

### 10:54 AM**-~-- --~**  

### Forwarded by Meredith Laws/DC/USEPAIUS on 02/1512011 

### 10:51 AM

----- From: To: Cc: Date: Subject "James Wagner" <james@wagnerreg.com> Leslye Fraser/DC/USEPAlUS@EPA Jim TompkinS/DC/USEPAlUS@EPA, '''Donnelly, Tim'" <TimD@amvac-chemical.com>, "'Kathryn E. Szmuszkoviez'" <kes@bdlaw.com>, "'Sarah S. Doverspike'" <SDoverspike@bdlaw.com>, Meredith Laws/DC/USEPAlUS@EPA, "'Yingxue Yu'" <yyu@redeagleinternational.com> 02/14/201107:51 

### PM RE: Amvac Chemical Corporation's Petition to Deny RedEagle International LLC's Application to Register Technical Tribufos
Dear Ms. Fraser, 

### I am following up on my email to you ofDecember 

### 13,2010 on this matter and to the attached email from Ms. Doverspike. As 

### I noted to you in my email from December, AMVAC is not listed as a data submitter for tribufos on the currentEPA Pesticide Data Submitters List. Therefore, atthe time ofRedEagle's application 

### to EPA, RedEagle could not have known that ArvIVAC had or would become the owner ofcertain tribufos data atEPA. Atthattime the EPA Data Submitters List indicated that Bayer CropScience owned tribufos data. Accordingly, RedEagle submitted a timely offer 

### to payto Bayer. However, since thattime we have received the EPA written confinnation ofthe transfer ofcertain tribufos data from Bayer CropScience to ArvIVAC. Therefore, on behalfofRedEagle International LLC, 

### I have submitted an offer to pay letterto ArvIVAC in this matter, copy enclosed. RedEagle believes that it has fully complied with the FIFRA requirements in this matter and it is 

### fully prepared to begin negotiations in good faith with AMYAC. RedEagle has an excellent record ofsettling its FIFRA data compensation obligations. Further, RedEagle contends thatthe petition by AMVAC is without significant merit and requests that the Agency deny ArvIVAC's request in this matter. Thankyou for your consideration in this matter. Sincerely, 

## Jim 'Wagner 1?Jgufatory Consu[tant to 1?J({cEagCe Internationa[ 

### 'TeC: 302-234-8550

Wagner

### Regulatory AsstXiates, Inc.

### From: Sarah S. Doverspike [mailto:SDoverspike@bd!aw.com] 

### Sent: Monday, February 14, 20114:31 PM 

### To: fraser.leslye@epa.gov 

### Cc: james@wagnerreg.com; tompkins,jim@epa.gov; Donnelly, Tim; Kathryn E. Szmuszkovicz 

### Subject: Amvac Chemica! Corporation's Petition to Deny Red Eagle International LLC's Application to Register Techn'lcal Tribufos
Dear Ms. Fraser: This email follows Amvac Chemica! Corporation's December 10, 2010 submission of the Petition to Deny RedEagle International LLC's Application to Register Technical Tribufos (Petition) (attached). An electronic vers'lon ofthe Petition was delivered to Red Eagle's agent, James Wagner, on December 10 and a hardcopy version was delivered to Mr. Wagner on December 13. Pursuant to 40 C.F.R. 

### § 1S2.99(b)(2), Red Eagle had 60 days from the date of his receipt ofthe petition to submit written comments to the Agency. Friday, February 11, 2011 was the 60th day since Red Eagle received the hardcopy version ofthe Petition and accordingly, the deadline for Red Eagle to submit a response has passed. Amvac has not received a respcmse to its Petition from RedEagle. Amvac would appreciate ifyou would confirm that Red Eagle has not submitted a response to EPA If RedEagle has submitted a response, we request that Red Eagle promptly provide Amvac with a copy of the response. If no response has been submitted to EPA, Amvac respectfully requests that the EPA grant as unopposed Amvac's Petition and deny RedEag!e's application to register technical tribufos. Denial of RedEagle's application pursuant to 40 C.F.R. 

### § 1S2.99(c)(3) is proper because RedEagle has failed to demonstrate compliance with all applicab!e data requirements, 40 C.F.R. 

### § 1S2.99(a)(2)(i), and provided to Amvac an insuffiCient offer to pay data compensation, 

### see 40 C.F.R. 

### § 1S2.99(a)(2)(vi). Thank you for your attention to this matter. Regards, Sarah Doverspike Sarah S. Doverspike Beveridge & Diamond, PC 1350 I Street, NW Suite 700 Washington, DC 20005 sdoverspike@bdlaw.com Direct: 202-789-6034 Fax: 202-789-6190 

## BEVERIDGE

# ~

# &DIAMOND~ CONFIDENTIALITY STATEMENT: This electronic message contains information from the law fInn ofBeveridge & Diamond, 

### p.e, and may be confidential or privileged. The information is intended solely for the use ofthe individual(s) or entity(ies) named above. Ifyou are not the intended recipient, be aware that any disclosure, copying, distribution, oruse ofthe contents ofthis message is prohibited. Ifyou have received this e-mail in error, please notify us immediately by telephone at (202) 789-6000 or bye-mail reply and delete this message. Thank you.

### Fw: Amvac Chemical Corporation's Petition to Deny Red Eagle International LLC's Application to Register Technical Tribufos Jim Tompkins 10: Hope Johnson 12/131201008:11 AM For Your Information Jim Tompkins Team Leader 25 Herbicide Branch RegiS1ra1ion Division Phone 703 305 5697 Fax 703 308 0029 Ewmail Tompkins.jim@EPAGOV**~-~~-~-~~~~~~~~~~~-**

.--. Forwarded by Jim Tompkins/DC/USEPAJUS on 12/13/2010 08:11 AM _w

From: To: Cc: Date: Subject: "Sarah S. Doverspike" <SDoverspike@bdlaw.com> leslye Fraser/DC/USEPAJUS@EPA <james@wagnerreg.com>,Jim TompkinsfDC/USEPAJUS@EPA,<TimD@amvao-chemical.com>, "Michael R. Neilson" <MNeilson@bdlaw.com> 12110/201004:31 PM Amvac Chemical Corporation's Petition to Deny Red Eagle International llC's Application to Register Technical Tribufos
Dear Ms. Fraser: Amvac Chemical Corporation respectfully submits for your consideration the attached Pe1ition to Deny Red Eagle International LlC's Application to RegiS1er Technical Tribufos. A hard copy of the Petition to Deny will be delivered to your office this afternoon, 

# l::;:> 

# g.51e1?5

- 

# RU
Please let me know ifyou have any questions. Thank you for your attention to this matter. Regards, Sarah Doverspike Sarah S. Doverspike Beveridge & Diamond, PC 1350 I Street, NW Suite 700 Washington, DC 20005 sdQverspike@bdlaw.com Direct: 202w789w 6034 Fax: 202·789w 6190 

# BEVERIDGE

# ~

# &DIAMOND~ CONFIDENTIALITY STATEMENT: This electronic message contains infonnation from the law fum ofBeveridge & Diamond, P.C., and may be confidential or privileged. The infonnation is intended solely for the use ofthe individua1(s) or entity(ies) named above. Ifyou are not the intended recipient, be aware that any disclosure, copying, distribution, or use ofthe contents ofthis message is prohibited. If you have received this ewmail in error, please notifY us immediately by telephone at (202) 789w 6000 or by ewmail reply and delete this message. Thank you.2010·12·10 Amvac Chemical Corporation Petition to Deny RedEagle International LLC_$ Application to R.PDF

# BEVERIDGE

# ~

# &DIAMOND~

BvElectronicAndHandDelivery, Leslye Fraser, Esq. Associate General Counsel December 10, 2010

Pesticides and Toxic Substances Law Office U.S. Environmental Protection Agency Mail Code 2333A Ariel Rios Building 1200 Pennsylvania Avenue, N.W. Washington, DC 20460 

### Re: Amvac Chemical Corporation's Petition to

### Deny Michael R. Neilson Sarah S. Doverspike

1350! street, N.W. Suite 700 Washington, D.C. 20005-33! 1 Direct: (202) 789-6061 (202) 789-6034 Fax: (202) 789-6190

mrn@bdlaw.com ssd@bdiaw.com



### RedEagle International LLC's Application to Register Technical Tribufos
Dear Ms. Fraser: Amvac Chemical Corporation ("Amvac") hereby petitions the United States Environmental Protection Agency ("EPA" or ''the Agency") to deny the "me-too" application of RedEagle International LLC ("RedEagle") to register with EPA a teclmical grade pesticide product containing the active ingredient tribufos. Amvac further petitions EPA to deny any related RedEagle tribufos end-use or other applications. Amvac submits this petition as the
owner ofessential data on file with EPA that are required for supporting a tribufos registration, and as the registrant responding to existing tribufos Data Call-Ins ("DCls',) issued by EPA. Amvac brings this petition under the Federal Insecticide, Fungicide and Rodenticide Act ("F1FRA"), as amended, 7 U.S.C. 

### § 136.136y,EPA'sregulations, including 40 C.F.R. Part 152,

### BEVERIDGE&DIAMOND,~ 

### Leslye Fraser, Esq. December 10, 2010 Page 2
the Petition Clause ofthe FirstAmendment, and the Administrative Procedure Act, 5 U.S.c. § 

## 555(b).In applying to register its tribufos product, RedEagle's offer to compensate Amvac fails to satisfY requirements, established by FIFRA § 

### 3(c)(I)(F) and EPA's implementingregulations, for RedEagle's reliance on Amvac's tribufos data. As detailed below, RedEagle's offerto pay does not satisfy requirements for registration because it fails to identifY applicable data requirements, fails to demonstrate how each data requirement is satisfied, and fails to cite Amvac data necessary to support its proposed registration. Inthe absence ofAmvac's receipt ofa complete and legally sufficient offer to pay from RedEagle, EPA should deny RedEagle's application for registration. RedEagle also has failed to satisfyrequirements for making a legally sufficient compensation offerto Amvac under FIFRA § 

### 3(c)(2)(B) or, to Amvac's knowledge, otherwise demonstrating howRedEagle will meet outstanding datarequirements for tribufos. Tribufos is subject to datarequirements under nels issued by EPA 

### in2000 and 2010, which impose significant requirements for additional environmental fate, environmental toxicology, toxicology and human exposure data. On a related point, anyregistration that ultimately is issued to RedEagle mustbe conditioned upon meeting existing data requirements underthe same deadlines as Amvac. Amvac recognizes that RedEagle has the optionto generate and submit its own data satisfying these requirements, but if

### it chooses to do so, RedEagle must submit the data 

### under deadlines already established by EPA. FIFRA § 

### 3(c)(7)(A). If, however, RedEagle ismeeting any outstanding datarequirements by relying on Amvac's responses to the DCls, it must make

## BEVERIDGE& 

## DIAMOND", Leslye Fraser, Esq. December 10, 2010 Page 3

an offerto pay WlderFIFRA § 

### 3(c)(2)(B) while RedEagle's application for registration is still pending. Thus, Amvac asks that EPA deny RedEagle's application unless and until RedEagle 

### makes a FIFRA § 

### 3(c)(2)(B) compensation offer to Amvac or demonstrates how RedEagle otherwise is meetingthese requirements.
FactualBackground 1. TribUfos Tribufos is an organophaphate defoliant used for cotton crops, specifically to defoliate cotton in preparation for mechanical harvesting. Based on tribufos data submitted to 

### EPA and an extensive public process, the Agency issued a Reregistration Eligibility Decision ("RED") for tribufos in 

### July 2006, confmning tribufos' continuing eligibility for registration. RedEagle's offer indicates that it seeks a registration identical to Amvac's existing registration oftribufos as currently approved by EPA. In

### 2000 and 2010, EPAissued DCIs for additional data considered necessary by EPA for supporting the registration oftribufos. (Attachments I and 2). These pending DCIs for tribufos include requirements for environmental fate, environmental toxicology, toxicology and human exposure 

### data to which Amvac is currently responding.
2. Amvac Owns the Tribufos Registration Data Amvac is the successor-in-interestto rights in tribufos data that originally were submitted by Bayer CropScience ("Bayer"). In

### July2010, Amvac acquired Bayertribufos registrations and supporting data submitted to EPA. On October 6, 2010, EPA fonnally approved thetransfer to

## BEVERIDGE&DIAMOND~ Leslye Fraser, Esq. December 10,2010 Page 4
Amvac from Bayer ofthe rights in the tribufos data on which RedEagle seeks 

### to rely. (Letter from S. Robbins (EPA) to M. Cherny (Bayer) dated October 6, 2010, Attacbment 3). Amvac also is Bayer's successor in responding to the existing requirements for data imposed 

### bythe tribufos DCIs. Following acquisition ofBayer tribufos registrations anddata, Amvac is responding to EPA concerning how Amvac will satisfy those data requirements.


### 3. RedEagle's Application and Offer to Pay RedEagle provided to Bayer a letter dated August 20, 2010 in which RedEagle states that it is submittingto EPA a registration application for a technical tribufos productfor all uses 

### currently approved by

### EPA (Letter from 

### J. Wagner to Bayer CropScience dated August 

### 20, 2010, Attachment4). RedEagle further states that in applying for this registration, 

### itis using the "cite-all under selective method ofdata support." RedEagle's letter did not, however, provide an «[i]dentification ofthe specific data requirement(s) for which the offerto pay for data is being made" as required under 40 C.F.R. 

### § 152.95(bX2)(ii). RedEagle's letter also fails to make a compensation offer pursuant to FIFRA 

### § 3(c)(2)(B) for data required under the pending DCls or indicate how RedEagle otherwise intends to satisfy the DCI requirements under other options. OnNovember 15, 2010, Amvac requested in Vlriting that RedEagle promptly correct defects in its offer to pay and application by providing Amvac with a copy ofthe datamatrix submitted to EPA in supportofRedEagle's selective method application. l 

### RedEagle has not

1 

### Ina prior letter dated October 26, 2010, Amvac informed RedEagle ofAmvac's acquisition ofBayertribufos registrations and dataandthat RedEagle must address its tribufos data compensation obligations with Amvac. Amvac has not received any response from RedEagleto this letter.

## BEVERIDGE**&DIAMOND,~** Leslye Fraser, Esq. December 10, 2010 Page 5 responded to Amvac'srequest for the infonnation requiredto correct defects in RedEagle's 

### tribufos registration application and offer to pay. Amvac further understands that 

### RedEagle may be requesting waivers for its 

### tribufos application ofcertain generally applicable product chemistry datarequirements. Amvac bases 

### this beliefon infonnation available from the National Pesticide Infonnation Retrieval Service (''NPIRS''). Amvac does not atthis time have access to sufficient details to fully evaluate RedEagle's application and decide whether to challenge RedEagle's request to be relieved of these data requirements applicable to registration oftechnical tribufos. However, Arnvac has submitted 

### data to satisfy suchrequirements and reserves the right to challenge these waiver 

### requests. Legal Background 1. FIFRA 

### § 3(c)(I)(F) and EPA Regulations Require RedEagle to Provide a Proper Offer to Pay Before EPA May Process RedEagle's Application A fundamental FIFRA requirement for registration applications is thatthey must be supported by data. FIFRA 

### § 3(c)(I)(F). UnderFIFRA, a follow-on applicant may cite, and EPA may consider, datathat were submitted by an original data submitter within the 15 years preceding the date ofthe follow-on application 

### "only 

## if the applicanthas made an offer to compensate the original data submitter and submitted such offer to the Administrator accompanied by evidence ofdelivery to the original data submitter ofthe offer." FIFRA 

### § 3(c)(I)(F)(lii) (emphasis added); 

## see 40 C.F.R. 

### § l52.93(b)(3) (a follow-on applicant may cite another company's study without pennission or an offer to pay only if"[t1he study was originally submitted to the Agency on orbeforethe date that is 15 years before the date ofthe

## BEVERIDGE&DlAMOND~ Leslye Fraser, Esq. December 10, 2010 Page 6 application for which it is cited',). Thus, FIFRA Section 3(c)(1)(F) "establishes a mandatory licensing scheme," whereby an applicant may cite data originally submitted to EPA 

### by another person only "once [the] applicant has extended a proper offer to pay compensation
...." EPA, 

### Pesticide Programs; Pesticide Registration and Classification Procedures; Application 

## Procedures to Ensure Protection a/DataSubmitters'Rights, 49 Fed. Reg. 30884, 30889 (Aug. 1, 1984). Without extending Amvac a proper offer to 

### pay, RedEagle cannot attemptto rely on Amvac's data in its own application. The protection ofan original data submitter's proprietary rights is so fundamental to FIFRA's framework that 

### "if[EPA] detennines that 

### an applicant for registration ofa producthas acted in any way that deprives an original data submitter ofrights under FIFRA section 3(c)(1)(F), theAgency 

### will take stepsto deny the application or cancd the registration, as appropriate." 40 C.F.R. 

### § 152.99(c)(3) (emphasis added). Consistent with FIFRA's plain language and system ofprotecting the proprietary rights oforiginal data submitters, EPA's regulations provide that an application for registration cannot be considered absent a proper offer to pay. 

## See, e.g., 40 C.F.R. 

### § 152.50(f) (application must include "materials to demonstrate that [the applicant] has complied with the FIFRA sec. 3(c)(1)(F)
... with respect to satisfaction of datarequirements"); 

### id at 

### § 152.42 (applications must contain the infonnation specified in 

### § 152.50). Indeed,"[aJn application is incomplete ifany pertinent item specified in 

### § 152.50 has notbeen submitted," 40 C.F.R. 

### § 152.104, and EPA "will not begin or continue the review ofan application that is incomplete." 

### Id at 

### § 152,105. As EPA confinned when it adopted its regulations, EPA "reI [iesJ heavily on data submitters to monitor compliance withthe procedures of
... [40 C.F,R. Part 152J subpart [E]."

## BEVERIDGE&DlAMONDec Leslye Fraser, Esq. December 

### la, 2010 Page 7
49Fed. Reg. at 30899. The only waythat a data submitter canperform this monitoring function is 

### ifEPA 

### ensures that it is provided a complete offerto pay at the time the follow-on application is submitted, that clearly identifies the data requirements applicable to the follow-on product and howthey are satisfied, as required by 

### EPA'sregulations. 

### See generally40 C.F.R. Part 152, Subpart E (establishing "Procedures To Ensure Protection ofData Submitters' Rights," including requirements governing selective and cite-all datacitation methods, the contents ofoffers to 

### pay, and procedures for data 

### submitters 

### to submit petitions to 

### deny or cancel follow-on registrations thatfail to comply).
2. FIFRA 

### § 3(c)(2)(B) Requires RedEagle to Provide a Compensation Offer to Rely on Amvac's Responses to the OeIs 

### orRedEagle Must IdentifyHowItOtherwise Will Satisfy Pending Data Requirements Under FIFRA 

### § 3(c)(7)(A), EPA may issue a registration to RedEagle only ifit is 

### conditioned upon submission or citation ofall datarequired for unconditional registration which have not yet been submitted no later than the time such data are required to be submitted for similar pesticide products already registered. Because EPA has issued pending nCls for tribufos to which Amvac is responding, FIFRA 

### § 3(c)(2)(B) requires RedEagle to issue a compensation offer to relyupon Amvac's existing responses to the two DCls ordemonstrate how RedEagle intends to otherwise satisfythe DCI's substantial datarequirements underthe options available to RedEagle.
3. Amvac Is Entitled to Petition EPA to Deny RedEagle;s Tribufos Application Amvac is entitled to file this petition pursuantto FIFRA 

### §§ 3(c)(I)(F) and 3(c)(2)(B), and EPA's regulations at 40 C.F.K Part 152, Subpart E ("Procedures To Ensure Protection ofData

## BEVERIDGE

## &DlAMOND" Leslye Fraser, Esq. December 10,2010 Page 8
Submitters' Rights"), including 40 C.F.R. 

### § 152.99. Amvac owns the data supporting 

### registration oftribufos and is responding to the existing

# nels. As the owner ofdata satisfying requirements for tribufos that RedEagle has failed to satisfy independently, and having received
an insufficient offer to pay data compensation from RedEagle, Amvac is entitled to submit this petition requesting that EPA deny RedEagIe's application. See 

### 40 C.F.R. § 152.99(a)(2Xvi). EPA has notyetissued RedEagle the registration at issue, and Amvac's petition is timely. 

## See 40 C.F.R. §I52.99(b)(I). In addition to Amvac's rights as a data 

### submitter under FIFRA and EPA regulations, EPA recognizes its 

### obligation to considerpetitions to 

### deny pursuant to 

### the Petition Clause ofthe First Amendment to the United States Constitution. 2 

### Amvac also is entitled to petitionEPA under theAdministrative Procedure Act (AFA), 5 U.S.C. § 555(b), which provides that "an interested person may appear before an agency ... for the presentation, adjustment, or determination ofan issue, request, or controversy in a proceeding
... or in connection with an agency function." 

### ld. Argument 

### 1. 

### RedEagle's Offer to Pay Is Deficient on Its Face A selective method applicant, such as RedEagle, must "list[] the specific data requirements that apply to his product, its active ingredients, and use patterns" and "must state

2 

### See, e.g., 

### Letterfrom J. Jones, Director, Registration Division, Office ofPesticide Programs, EPA, to J. 

### Wright and J. 

### Liss (June 13,2000) (recognizing the right to petition to deny applications under the First Amendment ofthe Constitution and under FIFRA); Letterfrom J. Jones, Director, Registration Division, Office ofPesticide Programs, EPA, to K. 

### Weinstein and E. Ruckert (Sept. 29, 1999) (stating that EPA gives consideration to issues raised regarding applications for registration independent ofthe right to file apetition under40 C.F.R. § 

### 152.99). i , ,

## BEVERIDGE&DIAMOND", Leslye Fraser, Esq. December 10,2010 

### Page 9
for each data requirement onthe list" how that requirement is satisfied. 40 C.P.R. §§ 

### 152.90, 152.90(b). To satisfy individual datarequirements by citing all pertinent studies, which RedEagle seeks to do, the applicant must identifyto the data submitter the "specific data requirement(s) for which the offer to pay for data is being made." 40 C.F.R. 

### § 152.95(b)(2)(ii). RedEagle's offer fails on 

### its face. RedEagle never identifies the data 

### requirements 

### that it considers to be applicable to its 

### technical tribufos application for which RedEagle relies on Amvac's data. RedEagle merely asserts 

### that it 

### "is using the cite-all under selective method of data support," without identifying a single applicable datarequirement. (Attachment 4). Instead, 

### RedEagle turns the application and offer to pay process on its head by demanding that Amvac, for each study for which it seeks compensation, "identify the data items and any tenns of compensation that you propose." Absent access to RedEagle's data: matrix, Amvac cannotknow whether RedEagle has cited all ofthe data required to obtain a tribufos registration and whether Amvac has secured, through the required offer to pay, the right to

### be compensated for studies on which RedEagle must rely. EPA cannot allow RedEagle to impose on Arnvac the applicant's obligation to properly and completely identify the applicable requirements for which data are cited. EPA need look no further than 

### RedEagle's offer to pay itself

### in denying RedEagle's application. Onits face, the offer falls shortofrequirements under EPA's regulations because it fails to identify datarequirements for which RedEagle relies onArnvac's studies. See 

### 40 c.P.R. 

### § 152.95(b)(2)(ii). This failure deprives Amvac ofits data rights and the opportunityto monitor 

### whether RedEagle identifies all data requirements applicable to its product as EPArelies on data submitters to do. RedEagle's application must 

### be denied on this basis.

### BEVERlDGE&DIAMOND~ Leslye Fraser, Esq. December 10,2010 Page 10
2. RedEagie Fails to Make a FIFRA § 

### 3(c)(2)(B) Compensation OfferNecessary for 

### Satisfying Outstanding Tribufos Data Requirements and Deadlines Any RedEagle tribufos registration must be subject to the same conditions, restrictions, data requirements and deadlines applicable to Amvac's tribufos registration. FIFRA and EPA regulations require that follow-on registrants meet all the same data 

### requirements as the existing registrant, by the same deadlines. 

## See FIFRA § 

### 3( c)(7)(A); 

## see alsa 40 C.F.R. § 

### 152.l15( a) 

### (stating that EPA 

### may issue a registration conditionedupon the submission or citation ofall data which are required for unconditional registration under FIFRA § 

### 3(c)(5), but which have not yet been submitted, "no later than the time such data are required to be submitted for similar pesticide products already registered"). RedEagle has failed to satisfy this requirementby issuing Amvac a Section 3(c)(2)(B) compensation offer for pending data requirements or showing how RedEagle 'Will otherwise satisfy those requirements. EPA has issued two DCIs for additional data supporting registration oftribufos, The pending data requirements include studies onthe environmental fate, environmental toxicology, toxicology and human exposure oftribufos. As the successorto Bayer, Amvac is actively responding to EPA in meeting these substantial pending data requirements. RedEagle's offer to pay does not list the pending data requirements applicable to 

### its tribufos registration application, including those requirements for which 

### it relies on Amvac's DCIresponses, Consequently, RedEagle fails to indicate whether RedEagle's application relies
on Amvac's response to the DCIs, for which it must issue a Section 3(c)(2)(B) compensation offer, or whether RedEagle intends to submit its own data satisfying the DCIs under applicable deadlines, Because RedEagle has neither listed the DCI datarequirements norprovided Amvac

## BEVERIDGE& 

## DlAMOND" Leslye Fraser, Esq. December 10, 2010 Page 11


### with a Section 3(c)(2)(B) offerto pay, EPA should deny RedEagle's applicationto register a tribufos product. 

### 3, RedEagle's Offer Fails to Identify Data Waiver Requests Based on infonnation available from NPIRS, 

### it appears that RedEagle is requesting waivers from EPA ofa number ofbasic product chemistry data requirements potentially 

### applicable to tribufos registrations and met by

### Amvac's data. Because RedEagle failed to provide a proper offer to pay identifyingthe data requirements applicable to its application, Amvac cannot identify reliably the 

### data requirements that RedEagle seeks to have waived. Thus, Amvac also cannot monitorRedEagle's application in this respect and decide whetherto challenge any wavier requests for failing to list a data requirement for which Amvac submitted required data. Until RedEagle corrects deficiencies in its offer to pay, it is notpossible for Amvac to evaluate RedEagle's application and whether there may be other substantive grounds under which 

### itis defective. Thus, EPA should deny RedEagle's application until Amvac is provided 

### with a proper offer to pay on whose basis Amvac can evaluate the adequacy of RedEagle's data citations and application.
Conclusion and ReliefRequest Amvac respectfully requests that EPA deny RedEagle's application for registration ofa technical tribufos product and any relatedtribufos applications that may be pending. RedEagle's offerto pay is deficient on its face 

### in failing to identify: 

### (1) data requirements applicableto RedEagle's application; (2) those data requirements for which RedEagle relies onAmvac's existing data and DCI responses; and (3) requirements for which RedEagle seeks waivers from

## BEVERIDGE&DIAMONo", Leslye Fraser, Esq. December 10, 2010 Page 12 citing Amvac's data on file 

### with 

### EPA. Allowing RedEagle's application to proceed will deprive 

### Amvac ofits 

### rights as a data owner, including its rights to compensation under FIFRA §§ 3(c)(l)(F) and 3(c)(2)(B) and EPA's implementing regulations, Thus, EPA should deny RedEagle's application absent a legally sufficient offer to pay that identifies 

### all applicable existing and pending data, and cites and offers to compensate Amvac for its data satisfying each requirement. 

### See 40 C.F.R. § 152.99(a)(2)(i) (grounds for denial include wherethe applicant «has failed to demonstrate compliance with all applicable data requirements"). JfRedEagle purports to provide a corrected offer to pay supporting 

### its tribufos application, Amvac requests that EPA provide it

### with a 

### thirty-day period to evaluate and respond to 

### RedEagle's identification ofthe applicable datarequirements and offerto 

### pay. Amvac should 

### be accorded this time to respond because itis required by RedEagle's own failure to properly support its 

### application initially by providing the identification ofdatarequirements mandated by EPA'sregulation at 40 C.F.R. §152,95(h)(2)(ii),


### No Waiver In 

### filing this Petition, Amvac does notwaive any ofthe rights available to it in any forum to seek further reliefunder FIFRA or any other source oflaw. Thank: you for your consideration. Sincerely,

Michael R. Neilson Sarah S. Doverspike Counsel for Amvac Chemical Corporation

## BEVERIDGE&DIAMOND" Leslye Fraser, 

## Esq. December 10, 2010 Page 13

cc: Mr. James Wagner, WagnerRegulatory Associates, Inc. Mr. Jim Tompkins, EPA, Office ofPesticide Programs, Registration Division Timothy 1. DOIlllelly, Esq., Amvac Chemical Corporation

### CERTIFICATE OF SERVICE 

### Ihereby certify that on this 10th 

### day ofDecember 2010, copies ofthis Amvac Chemical Corporation Petition to Deny RedEagle International LLC's Application to Register Technical Tribufos were delivered to the following individuals by the methods specified below:
Ms. Leslye Fraser Associate General Counsel Office ofthe General Counsel Pesticides and Toxic Substances Law Office U.S. Environmental Protection Agency Ariel Rios Building, Mail Code 2333A 

### 1200 Pennsylvania Avenue, N.W. Washington, DC 20460


### James M. 

### Wagner 

### EPA Agent for RedEagle International LLC Wagner Regulator Associates, Inc. 7460 Lancaster Pike, Suite 9 Hockessin, DE 19707 

### Hand Delivery

FEDEX"


# Attachment 1

# .' 

# •

•



# • -=flo.sher 30

# t-'+

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



### GENERIC DATA CALL-IN NOTICE


### CERTIFIED MAIL Mr. Delmont Eberhart Bayer Corporation 8400 HawthornRoad 

### P.O. Box 4913 Kansas City, MO 64120-0013 

### Dear

### Mr. Eberhart: BAYER CORPORATION R&D REGISTRATIONS SECTION OFFICI!: OF PRNElmDN, I'£STlClDEI ANO TOXIC SOB5TAHCeS



### ThisNoticerequiresyou and

### otherregistrants of pesticideproducts containingtheactiveingrediem(5) identified in 

### Attachment I oftmsNotice, the Data CaIHn Chemical Status Sheet, to 

### submit 

### certain dataasnotedhereintothe U.S. Environmental ProtectionAgency (EPA,theAgency). Thesedataare 

### necessaryto

### maintain

### thecontinuedregistrationafyourproduct(s)containingthisactiveingredient(s). 

### Within 90 days afteryou receive this Notice you mustrespond as set forth 

### inSectionIII below. Your response must state: L how you'will comply 

### with the requirements set forth in 

### this Notice and 

### its Attachments I 

### through 4; 

### or, 2. why youbelieveyou areexemptfromthe 

### requirements listedinthisNotice andinAttachment 3, &quirements Status and Registrant's Response Fonn, (see section III-B); or, 3. why you believe EPA should notrequire your submission ofdata in

### the manner specified by this Notice (see section III-D). Ifyou do notrespondto thisNotice, or ifyou do not satisfy EPA that 

### you will comply with its requirementsorshouldbeexemptorexcusedfrom doingso, thentheregistrationof yourproduct(s) subject to this Notice wUl be subject to suspension. We have provided a list ofall ofyoutproducts 

### subjectto this Notice inAttachment 2, DataCaIHn Response F9rm, as well as a listofallregistrants who 

### were sent this Notice (Attachment4), The authority for this Notice is section 3(c)(2)(B) ofthe Federal Insecticide, Fungicide and Rodenticide Act as amended (FIFRA), 7 U.S.C. section I36a(c)(2)(B), and 

### section408(t)(1)(A) of theFederal Food, Drug, and CosmeticAct**(FFDC~),** 

### 21 U.S.C. section 346a(f){I)(A). Collection

# •

•



# • of this information is authorized under the Paperwork Reduction Act by 

### OMB Approval No
.**2070~O** 

### 1 07 and**2070~0057** 

### (expiration date 3-3 1-99), This Notice is divided into six sections and fIVe 

### Attachments. The Notice 

### itself contains infonnationand instructions applicable

### toall DataCalI-In Notices. TheAttachmentscontain specific chemical information and instructions. The sixsections of theNotice are: Section I Section II Section III Section IV 

### Section V Section VI 

### Why You Are 

### Receiving This Notice Data Required 

### By ThisNotice Compliance With Requirements OfThis Notice Consequences OfFailureTo Comply With 

### This Notice Registrants' Obligation To Report Possible Unreasonable AdverseEffects Inquiries And Responses To This Notice The Attachments to this 

### Notice are: Attachment I - 

### Attachmenty': Attachmen.t**J..'~­** 

### Attachmentk""

- Data CalMn Chemical Status Sheet 

### Data Call-In Response Form (InsertA) Requirements Status And Registrant's Response Form (InsertB) List OfAll Registrants Sent This Data Call-InNotice
SECTION l. 

### WHY YOU ARE RECEIVING THIS NOTICE The Agency has 

### reviewed existing data for this active ingredient(s) and reevaluated the data 

### neededto supportcontinuedregistration of thesubjectactive ingredient(s) andthe continuationofany existing tolerances orexemptions for such active ingredient. This 

### reevaluation identified additional data necessary to assess the health and 

### safety of the 

### continued use ofproducts containingthis active ingredient(s). Vou have been sent this Notice because you have product(s) containing the subject active ingredicnt(s). SECTION II. DATA REQUIRED BY THIS NOTICE A. 

### DATA REQUIRED The data required by 

### this Notice are specified in 

### the ReQuiremcnts Status and Registrant'sResponse

## Fonn (InsertB). Dependingontheresultsof thestudies required 

### in

### this Notice, additional testing may bc required
.

# •

•



# • B. SCHEDIILE FOR SUBMISSION OF DATA 

### Youarerequiredtosubmitthedata

### orotherwise satisfythe datarequirementsspecified in Attachment 3. Requirements Statu.« and Registrant's Response Fonu (InsertB), within the 

### time frames provided. 

### C. TESTIN() 

### PROTOCOL All studies required tmder 

### this Notice must be conducted 

### in accordance with test standards outlined 

### in the Pesticide Assessment Guidelines for those studies for which guidelines have been established. 

### TheseEPA Guidelines are availablefrom the NationalTechnical Infonnation Service (NTIS), Attn: OrderDesk, 5285 Port Royal Road, Springfield, Va22161 (tel: 703-605-6000). Protocols approved by 

### the Organization forEconomic Cooperationand 

### Development (OECD) 

### are also acceptable if

### the GECD-recommended 

### test standards confonn to 

### those specified 

### in the

### Pesticide Data Requirements regulation (40 CFR 

### § 158.70). Whenusing 

### the DECO protocols, they 

### should be modified as appropriate so that 

### the data generated by 

### the study will satisfy the requirements of40 CFR § 

### 158. Normally, the Agency will not extend deadlines for complying with data 

### requirements when the studies 

### were not conducted 

### in accordancewith

### acceptable standards. The 

### OECDprotocols are 

### available from 2001 L 

### Street. N.W., 

### Washington, D.C_ 20036 

### (Telephone number 202-785-6323; 

### Fax telephone number 202.785.0350). 

### All 

### new studies 

### and proposed protocols submitted 

### in response to 

### this Data Call-In Notice must

### be inaccordancewith Good Laboratory 

### Practices [40 

### CFR Part 16O.3(a)(6)]. D. 

### REGISTRANTS RECEIVING PREVIOUS SECTION 3(c)(2)(8) OR (4)WW(A) NOTICES ISSUED BY THE 

### AGENCY Unless otherwise noted herein. this Data Call-In does not in 

### any way supersede Qr changetherequirementsofany

### previous DataCalJ.Jn(s). 

### orany otheragreementsentered

### into with the AgefEy pertaining to 

### such prior Notice. Registrants must comply with the requirements of

### aU Notices to 

### avoid issuanceofa Notice ofIntent

### to Suspend their 

### affected products. 

### SECTION IT!. COMPLIANCE WITH REOUIREMENTS OF THIS NOTICE A. SCHEDULE FOR RESPONDING TO THE AGENCY The 

### appropriate responses initially required by this

### Notice must be submitted to 

### the Agency within 90 days afteryourreceiptofthis Notice. Failure to adequately respond to

### this Notice within 90 days of your receipt

### will be

### a basis for issuing aNotice ofIntentto Suspend (NOIS) affecting yourproducts. This and other bases for issuance ofNOIS due to 

### failure to 

### comply with

### this Notice are presented in Section IV-A and IV-B.

# •

•



# • B. OPTIONS FOR RESPONDING TO THE AGENCY The options for responding to this Notice are: I) voluntary cancellation,. 2) delete 

### use{s), (3) 

### claim generic data 

### exemption, (4) agree to satisfy the datarequirements imposed by this Notice or (5) request adata waiver(s). A discussion ofbow to respond if

### you chosethe Voluntary Cancellation option, the 

### Delete Use(s) optionorthe Generic DataExemptionoption is

### presentedbelow. Adiscussion of

the

### various options available forsatisfyingthe datarequirementsof thisNoticeis contained in**S~on** 

### III-C. A discussion ofoptions relating to requests for datawaivers is contained in Section Ill-D. There are two forms that accompany this Notice ofwhich, depending upon your 

### response, one orbothmustbeused in

### yourresponseto

### the Agency. Theseforms arethe

### DatA: Call-In Re.-monse Form (Insert A) and the Requirements 

### Status and Registrant's Response 

## Em:m (Insert B). The Data Call-In Response Form (Insert A) must 

### be submitted as 

### part of 

### every response to 

### this Notice. Please note that the company's authorized representative is required to 

### signthe

### first pageof the 

### DataCall-InResponse FOnD (InsertA) andRequirements Status andRegistrant's ReWQnse Fonn (Insert

### B) andinitial any subsequentpages.Thefonns contain separate detailed instructions on the response options. Do not alter the printed material. If you have questions orneed assistanceinpreparingyourresponse, call orwrite the contact person identified in Attachment L 

### l. Voluntan' Cancellation

- You may avoid the requirements of

### this Notice by requestingvoluntary caneellationofyourproduct(s)containingtheactiveingredient(s) that is

### the subjectof

### this Notice. Ifyou wish to 

### voluntarily cancel yourproduct, you must submit a completed Data Call-In Response Fonn (Insert A), indicating your election ofthisoption. Voluntary cancellation is item number 5 on the DataCall-In ReSpOnse 

### Fonn (InsertA). If you choosethis option" this 

### is the 

### only fonn 

### thatyou are required to 

### complete. Ifyou choose to

### voluntarily cancel yourproduct. further saleand distribution of yourproductaftertheeffective date ofcancellationmust be 

### in accordance with

### the Existing Stocks provisions ofthls Notice which are contained in Section IV-C. 2. 

### Use Deletion

- You may avoidthe requirements of thisNotice by eliminating the uses ofyourproduct

### to whichthe requirements apply. Ifyouwish to amendyout registrationto delete uses, you must submit the Requirements Status and Registrant's Response Fonn (Insert B), a completed application for amendment. a copy ofyout proposed amended labeling, and all other infonnation required for processing the application. Use deletion is option number 7 on the Requirements Status 

## and Registrant's Response Form (Insert B). Vou must also complete a Data Call-In Res,ponse Fonn (Insert A) by signing the certification, item number 8. Application forms foramending registrationsmay be obtained from theRegistration Supportand Emergency Response Branch, Registration Division, (703) 308-8358,

# •

•



# • !

Ifyou choose 

### to delete the use(s) subject to this Notice or uses subject to 

### specific 

### data requirements, further sale, distribution, oruse of your product after one year from the due date ofyour 90 day response, must bear

### an amended label. 

### Note: 

## If allregistrantsfoT

### thesubjectactive ingredientrespondto this notice by requestingcancellation ordeletion o/usesalltolerances associatedwith the registration ordeleted uses will be revoked pursuant to FFDCA section 408(/)(2). 

### 3, Generic Data Exemption

- Under section 3(c)(2)(O) ofFIFRA, an applicant forregistrationofa product is exempt from therequirementto submit orcite generic data concerning an active ingredicnt(s) 

### ifthe active ingredient(s) in the product is 

### derivedexclusivelyfrompurchased,registeredpesticideproductscontainingthe active ingredient(s). EPAhasconcluded, asanexerciseofitsdiscretion,

### thatitnonnallywill 

### not suspendtheregistration ofaproductwhich

### would qualifY and 

### continue to 

### qualify for the generic dataexemption in section 3(c)(2)(D) ofFIFRA. To qualify, 

### ruJ ofthe following requirements must be 

### met: 8. The active ingredient(s) in your registered product must be present 

# wrux because ofincorporation ofanotherregistered product which contains the subject active ingredient(s) and is purchased from a source not connected withyou; and, b. every registrant who is the ultimate source oftheactive ingredient(s) in your prodUct subject to this DCI must be in compliance with the requiremcnts ofthis Notice and must remain in compliance; and


### c. you must haveprovidedto EPA an accurate and current "Confidential. StatementofFonnula" for eachof yourproductsto whichthisNotice applies. To apply for the Generic Data Exemptionyoumust submit a completed l2!!:g 

### Call-In Response Form (Insert A), 

### and all supporting documentation. The Generic DataExemption is itemnumber6aonthe DataCall-In Regwnse FOOD. (InsertA). If youclaimagenericdataexemptionyouare notrequiredtocompletetheRequirements Status!llldRegistrant's 

### Response Form(InsertB), GenericDataExemptioncannotbe selected as an option for product specific data, 

### Ifyou are granted a GenericDataExemption, yourely on the efforts ofother persons to provide the Agency with the required data. 

### Ifthe registrant(s) who have committed to generate and submit the required data fail to take appropriate 

### steps to meet the requirements or are no longer in compliance withthis Data Call-In Notice, the Agency will consider that 

### both they and 

### you are not in compliance and will nonnal1y initiate proceedings to 

### suspend 

### the registrations of both your and their 

### product(s), unless yoU commit to submit and 

### do submit the required data

### within the specified time. In such casestheAgency generally will not grant atime extensionfur submittingthe data.



# ,. ,

# •



# •

• 4. Satisfringthe 

### Data Requirements ofthis Notice w There are various options 

### available to 

### satisfy the data

### requirements ofthis Notice. These options are discussed in Section IIIwC ofthis Notice andcompriseoptions I through 6onthe Requirements Status and 

### Registrant's Response Form (Insert B) and option 6b and 7 on the Data 

### CallwInResponse Form(lnsertA).lfyouchooseoption 6b or7,youmust submit both forms as well as any 

### otherinfonnationldatapertaining to 

### the optionchosento address the data requirement. 5. Requestfor DataWaivers. DatawaiversarediscussedinSection

### IIIwDofthis Noticeandare coveredby options 8and 

### 9onthe Requirements

### Status and 

### Registrant's Response From (InsertB). Ifyou chooseoneof these options, you must submitboth forms as well as any otherinformation/data pertaining to

### the optionchosento address the data requirement. C. SATISFYING THE DATA REQUIREMENTS OF THIS NOTICE Ifyou acknowledge onthe

### Data CallwIn Response FOnn (Insert A) 

### that you agree to 

### satisfy the 

### data requirements (i.e. you select option 6b and/or7), 

### then youmust select one of the sixoptionsontheReauirement.<; Statusand 

### Registrant'sResponse Faun(Insert

### A)related to dataproduction for each datarequirement. Youroption selection should be

### enteredunder itemnwnber9, "RegistrantResponse." The sixoptions relatedtodataproduction

### arethefirst six optionsdiscussed under

### item9 in the 

### instructions for completingthe 

### Requirements Status and Regjsttant's 

### Response Foon 

### (InsertB). 

### These six 

### options are 

### listed immediately below with infonnationinparenthesesto guideregistrants to

### additional instructions providedin this Section. The options are: 1. I 

### will generate and submit data within the specified time frame (Developing Data), 

### 2. I have 

### entered into an 

### agreementwith 

### one or moreregistrants to develop data 

### jointly (Cost 

### Sharing), 

### 3. I have made 

### offers 

### to**cost~share** 

### (Offers to 

### Cost Share), 

### 4. I

### am submittinganexistingstudythathas

### not

### been submittedpreviouslyto

### the Agency by 

### anyone (Submitting an

### Existing Study), 

### 5. Iam submittingorcitingdatato upgrade astudyclassified by

### EPAaspartially acceptable and upgradeable (Upgrading a Study), 6. 

## r am 

### citing an 

### existing study that EPA has classified as 

### acceptable or an existing study that 

### has beensubmittedbutnotreviewedbytheAgency (Citing 

### an Existing Study). Option I,**Deyelopin~** 

## Data

# •

•



# • Ifyou 

### choose to develop the required data 

### it 

### must be in confonnance with 

### Agencydeadlines and

### with

### otherAgencyrequirements asreferencedherein and inthe attachments. AU 

### datagenerated and

### submittedmustcomplywith

### the 

### GoodLaboratory Practice (GLP) rule (40 CFR Part 160), 

### be conducted according to the Pesticide 

### Assessment Guidelines (PAO), and be

### in confonnance wlth the requirements ofPR Notice 86-5. In addition. certain studies require Agency approval of testprotocols in 

### advance ofstudy 

### initiation. Those studies for which a protocol must be submitted have 

### been identified in the Requirements StatllS and Registrant's Response 

## Fonn (Insert B) 

### and/or footnotes to 

### the fonn. lfyou wish to use a protocol**~hich** 

### differs 

### from the options discussed in Section**lI~C** 

### ofthisNotice, you must submit a detailed description ofthe proposed protocol and your reason for wishing to USe 

### it. The 

### Agency may choose to reject a protocol not specified in 

### Section II-C. If the Agency rejects your protocol yOll 

### will be notified in writing, however, you should be aware that

### rejection ofaproposedprotocol will notbe abasis for extendingthedeadlinefor submissionofdata. A progress report must be submitted for each study within 

### 90 days from the 

### dateyou are required to committo generate orundertake someothermeans to

### address that 

### study requirement, such as making an offer to

### cost-share or agreeing to share in the 

### cost ofdeveloping that study. A 90-day progress report must 

### be submitted for all studies. This 90-day progress report must include the date the study 

### was or will be initiated and, 

### forstudies to

### be 

### started within 12 

### months of commitment. the name and address ofthe laboratory(ies) orindividuals who are orwill be conductingthe 

### study
. In addition, ifthe 

### time frame for submission ofa 

### final report is more than I 

### year, interim reports must be submitted at 12 

### month intervals from the date you are requiredtocommit to generateorotherwise address the 

### requirement for the study. In 

### addition to

### the otherinfonnation specified inthe precedingparagraph, at aminimum, a 

### briefdescription ofcurrent activity on and the status ofthe study must 

### be included as

### welI as afull description of any problems encounteredsincethe lastprogress report. The time frames inthe 

### Requirements Status and Registrant's Response form (Insert B) are the time frames that the Agency is allowing for the submission of completed study reports orprotocols. The noted deadlines run from the date ofthe receipt ofthis Notice bythe registrant. If the data are not submitted by the deadline, each registrant is 

### subject to 

### receipt of a Notice of mtent to Suspend the affected registration(s) and the affected tolerances or exemptions are subject to

### revocation. If

youcannotsubmitthedata/reportsto

### theAgency inthe timerequiredbythis Notice andintendto seekadditionaltime to meettherequirement(s), you mustsubmit a request to the Agency which includes: (l) 

### a detailed description ofthe expected difficulty and (2) a proposed schedule including alternative dates for meeting such requirements on a step-oby-step basis. You must explain any technical or laboratory difficulties and provide documentation from the laboratory performing the testing. While EPA is considering your request, the 

### original deadline remains. The Agency

# •

•



# • will respond to your request in writing. IfEPA does not grant your request. the 

### original deadline remains. Normally, extensions can be 

### requested only in cases of extraordinary testing problems beyond the expectation or control ofthe registrant. Extensions will not be givenin submittingthe 90-day responses. Extensions will not be 

### considered if the

### request for extension is not made in

### atimelyfitshion; in

### no event shall an extension request be 

### considered 

### if

### it is submitted at or after the lapse ofthe 

### subject deadline. Option 2. Agreementto Share in Cost to Develop Data

- Ifyou 

### choose to enter into an agreementto share in the costofproducing 

### the required databut

### wiII notbe submitting the datayourself, you must providethe name ofthe registrant who will be

### submitting the data. You must also provide EPA 

### with documentaty evidence 

### that an agreement 

### has been funned. Such evidence may be 

### yourletterofferingto

### joinin

### anagreementandtheotherregistranfsacceptanceof your offer, orawritten statement by

### theparties thatan agreement exists. The agreement to 

### producethe dataneed notspecif)tallof theterms of the ftnal arrangementbetweenthe partiesorthemechanismto resolve theterms. Section3(c)(2)(B)provides

### that if 

### the parties 

### cannot resolve the tenns ofthe agreementthey may resolve their differences through binding arbitration. Option 3. Offer to Sharejn the 

### Cost 

### orDataDeyelopment Ifyou have made an offer 

### to pay in an attempt to enter into an agreement or amend an existing agreement to meet the requirements ofthis Notice andhave been unsuccessful, you may request

### EPA (by 

### selectingthis option)to exerciseits discretion not to suspend your registration(s), although you do not comply with the data submissionrequirements of this Notice. EPA has 

### determinedthat 

### as ageneral policy, absent other relevant considerations, it

### will not suspend the registration ofa product ofa registrant who has in 

### goodfaith sought and 

### continuesto seekto enter into ajoint datadevelopment/cost sharingprogram,butthe otherregistrant(s)developing thedata has 

### refused to accept your offer. To qualify for this option, you must submit documentationtothe Agencyprovingthat

### youhavemadean offertoanotherregistrant (who has an obligation to 

### submit data) 

### to 

### shareinthe burden ofdeveloping that data. 

### You must also submit to theAgency a completed EPA Form 8570-32, Certification ofOffer to CostSharein the Development ofData. lnaddition, youmustdemonstrate that the other registrant to whom the offer was made has not accepted your offer to enterintoa cost sharing

### agreementby including acopy ofyomofferand 

### proofofthe other registrant's receipt ofthat 

### offer (such as a certified mail receipt). Your offer must, in

### addition to 

### anything else, offerto share 

### in the 

### burden ofproducing the data upon teons to 

### be agreed 

### orfailing agreement to 

### be bound by binding arbitration as provided by FIFRA section 3(c)(2)(B)(ru)and 

### mustnotqualify this offer. The other registrant mustalso informEPA ofitselectionofanoptionto develop andsubmitthe data 

### required by this Notice by 

### submitting a Data Call·In Response Fonn (Insert A) and a Requirements Status and Registrant's Response Fonn (Insert B) committing to 

### develop and submit the 

### data required by 

### this Notice.

# •

•



# • In order for you to avoid suspension underthis option, you may notwithdraw your offer to share in 

### the burdens ofdeveloping the data. In 

### addition, the other registrant must 

### fulfill its commitment to 

### develop and 

### submit the data as required by 

### this 

### Notice. Ifthe other registrant fails to develop the data orfor some other reason is subject to suspension, your registration as well as that ofthe other registrant will nonnally be 

### subject to initiation ofsuspension proceedings. 

### unless you commit to 

### submit. and 

### do submittherequired data in

### the 

### specifiedtimeframe. In suchcases, the Agency generally will not

### grant a time extension for submitting the data. Option4. Submitting an Existing Study

- 

### Ifyou 

### choose to 

### submit an existing 

### study in

### response to

### this Notice, you must determinethatthe study satisfiesthe requirements imposed by this Notice. You may only submitastudy thathas

### notbeenpreviously submitted

### to theAgency orpreviously cited 

### by anyone. Existing studies are studies 

### which predate issuance ofthis Notice. Do not use this option 

### ifyou are submitting data to

### upgrade a study. (See 

### Option 5). You should be aware that if

### the Agency determines that the study is not acceptable. the Agency willrequireyou 

### to comply withthisNotice, normally without an extension ofthe required date ofsubmission. The Agency may determine 

### at any 

### time that a study is not valid and needs 

### to be repeated
. To meet the requirements ofthe DCINotice for submitting an existing study, all ofthe following three criteria must be clearly met

# •

•

• a. 

### You mustcertifYatthetimethatthe existing studyis submittedthatthe raw data 

### and specimens from the study are availablefor audit and 

### review and yOll mustidentifY wherethey 

### are available. This

### must be done in

### accordance with

### the requirements ofthe Good Laboratory Practice (GLP) regulation, 40 CFR Part 160. As stated in40CFR 160.3(7) 

### "rawdatameansany laboratory 

### worksheets, records, memoranda, notes, orexact copies thereof, that 

### are the result oforiginal observations and activities of

### a study 

### and are necessary for the reconstruction and evaluation of the reportof that study. Inthe 

### eventthat exacttranscripts of raw data have beenprepared (e.g., tapes which have 

### been 

### transcribedverbatim, dated,andverifiedaccurateby 

### signature),theexactcopy orexacttranscriptmaybe substitutedfortheoriginal source as rawdata. 

### Raw data 

### may include photographs, microfilm or microfiche copies, computer printouts, magnetic media, including dictatedobservations, and recordeddata 

### from automated instruments," The term "specimens", according to 40 CPR 160.3(7), 

### means "any material derived from atest 

### system for examination or analysis." b. Healthand safety 

### studies completed afterMay 1984

### must also 

### contain all GLP-required quality assurance and quality 

### control infonnation, pursuant to the requirements of40 CFR 

### Part 160. 

### Registrants must also certifY atthe time ofsubmitting the existing study that such GLP infonnation is available for post-May 1984 

### studies by including an 

### appropriate statement on or attached to the study signed

### by an 

### authorizedofficial or 

### representative of the registrant.
c. YoumustcertifYthat each study fulfills the acceptance criteriaforthe Guideline relevant to the 

### study provided in the FJFRA 

### Accelerated Reregistration Phase 3 Technical Guidance and 

### that the study has 

### been conducted according to the Pesticide Assessment Guidelines (pAG) ormeets the purpose ofthe PAG (both available from NTIS). A study not conducted according tothe 

### PAG may be 

### submittedto

### the 

### Agencyforconsideration if the registrant believes that the study clearly meets the purpose ofthe PAG. The registrant is referred to 40 CPR 158.70 which states the Agency's 

### policy regarding acceptable protocols. Ifyou wish to 

### submit the study, you must, in addition to certifying that the purposes ofthe PAG are met by 

### the study, clearly articulate the 

### rationale why you believethe study meets thepurposeof thePAG, includingcopies ofany supporting informationordata. 

### Ithas been 

### the Agency's experience that studies completed prior to January 1970 rarely satisfied the purpose ofthe PAG and 

### that necessary raw dataare llSuallynot available for such studies. Ifyou submit an existing study, you must certify thatthe study meets all 

### requirements ofthe criteria outlined above
. If EPA has 

### previously reviewed a protocol for a study you are submitting, you must identifY any action takenbythe Agency on the protocol

# •

•

• and mustindicate, as

### partof yourcertification,the mannerin whichall Agency 

### comments,. concerns, or issues were addressed inthe fmal protocol and study. If

### you know ofa study pertaining to 

### any requirement in this Notice 

### which does not meet the criteria outlined above but does contain factual information regarding unreasonable adverse effects. you must notify the AgencyofStIch 

### astudy. Ifsuch astudy is in

### the Agency's files, youneedonly 

### citeit

### along with

### the notification. IfnotintheAgency's files, you mustsubmit a summary and copies as required by 

### PRNotice 86-5. Option 5. Upgrading a Study

- 

### Ifastndyhas been classified aspartiallyacceptable and 

### upgradeable, you may submit data to 

### upgrade that 

### study. The 

### Agency will review the 

### data submitted and 

### detennine if

### therequirementis satisfied. Ifthe Agency decidestherequirement is 

### not satisfied, you may still be 

### required 

### to submit new data normally without any time extension. Deficient, but upgradeable studies will normally be classified as 

### supplemental. However, it is 

### important to note that not aU studies classified as supplemental are 

### upgradeable. Ifyou have questions regarding 

### the classification of a study orwhether a study maybeupgraded, call or write the contactperson listed in Attachment I. Ifyou submit data to upgrade 

### an existing study you must 

### satisfY or supply infonnation to 

### correct 

## i!ll deficiencies in 

### the study identified by EPA. You mustprovide aclearlyarticulatedrationaleof howthedeficiencieshavebeen

### remedied or corrected and why the study should be rated as 

### acceptable to 

### EPA. Your submission must also specify the MRID 

### number{s) of the study which you 

### are attempting to upgrade and mustbe 

### in confonnance with PRNotice 86-5. Do not submit additional data for thepurpose ofupgrading a study classified as unacceptable and detennined by the Agency as not capable ofbeing upgraded. Thisoption shouId alsobeused to

### citedatathat

### has beenpreviously submitted to upgrade 

### a study, but

### has notyetbeen reviewed by the Agency. You must provide the MRlD number ofthe data submission as well as the MRID number ofthe study being upgraded. The criteria for submitting an existing study, as specified in Option 4 above, apply 

### to al1 data submissions intended to upgrade studies. Additionally your submissionof dataintendedto upgrade studiesmustbeaccompaniedby acertification thatyoucomply with

### eachof those criteriaas well as acertificationregarding protocol compliance with Agency requirements. Option 6. CitingExisting Studies-- Ifyou choose to 

### cite a study that has 

### been previously submittedto 

### EPA, that 

### study musthavebeenpreviously classified by EPA as acceptable oritmustbeastudy which has 

### not yet been reviewed by the Agency. Acceptable toxicology studies

# •

•



# • generally will have been classified as**"core~guideline"** or "core minimum." For 

### ecological effects studies, the 

### classificationgenerally would be a rating of"core." For all 

### other disciplines the classification would be "acceptable." With respect to any 

### studies for which you wish to select this option you mustprovide the MRID number ofthe study you are citing and, if

### the study has been reviewed by the Agency, you mustprovide the Agency's classificationofthe study. Jfyou are citing 

### a study ofwhichyou are notthe original data SUbmitter, yOU must submit a completed copy ofCertificationwith 

### Respect to Citations ofData (in 

### PRNotice 98-5) EPA Form 8570-34
. D. REQUESTS FORDATA WAIVERS 

### There are two

### types of data waiverresponses to this Notice. The first is a request for 

### a low volume/minor use waiverand the second is 

### a waiver request based

### on yourbeliefthat the 

### datarequirement(s) are inapplicable and do not apply to your product 

### I. Low VolumeIMinorUse Waiver Option 8onthe Requirements Status and 

### Registrant's Response Form (InsertB). Section3(c)(2)(A)ofFIFRArequires EPAto 

### consider the appropriateness ofrequiring data for low volume, minor use pesticides. Inimplementing this provision EPA considers as low volume pesticides only those activeingredient(s)whosetotal

### productionvolumeforallpesticideregistrantsissmall
. In determining whether to 

### grant a low volume, mioor use waiver the Agency wiU 

### consider the extent,pattern and 

### volume ofuse, the economic incentive to conductthe testing, the importance ofthe pesticide, and the exposure and 

### risk from use ofthe pesticide. Ifanactiveingredient(s) is 

### usedfor bothhlghvolumeandlowvolumeuses, a lowvolumeexemption will

### notbe approved. Ifall uses ofanactive ingredient(s) are low volume and the 

### combined volumes for all uses are also low, then an exemption may be granted, depending on review of other information outlined below. An exemption will not be 

### granted ifany 

### registrant ofthe active ingredient(s) elects to 

### conduct the testing. Any 

### registrant receiving a low volume minor use waiver must remain withinthe salesfigures in theirforecast supporting the

### waiverrequest inorder to

### remain qualified for suchwaiver. Ifgranteda waiver, a registrantwill be 

### required, as aconditionofthe waiver, to 

### submit annual salesreports. The

### Agency willrespond to requests for waivers in writing. To apply for a low volume, minoruse waiver, you must submitthefollowing information, as applicable to 

### yourproduct(s), as part 

### ofyour 9()..day response to this Notice:

a. 

### Total company sales (pounds and dollars) ofall registered product(s) containing the active ingredient(s). Ifapplicable to 

### the active ingredient(s), include foreign sales for those productsthat are notregistered inthis country but are applied to sugar(cane or beet), coffee, bananas, cocoa, and othersuch crops. Present the above information by yearfor each ofthe past

### five years.

# •

•



# • b. Provide an estimate ofthe sales (pounds and dollars) ofthe active 

### ingredient(s) for each major use site. Present the above information by year for each ofthe past five years.


### c. Total direct production cnst of product(s) containing the active ingredient(s) by year for the past five years. Include information on raw material cost, direct Iaborcost,advertising, salesand marlceting, and any other significant costs listed separately. 

### d. Total indirect production cost (e.g. plant overhead, amortized plant and equipment) charged to product(s) containing the 

### active ingredient(s) by 

### yearforthe pastfive years. Exclude all non-recurring costs that

### were directly related to the active ingredient(s). such as costs ofinitial registration and any data development.
e. A list ofeach datarequirement for whichyou seeka waiver. Indicate the type ofwaiver sought and the estimated cost to you

### Oisted separately for 

### eachdatarequirernentand associated test) 

### of conducting the testingneeded

### to fulfill each ofthese data

### requirements. f. A 

### list of each data 

### requirement for which you are 

### not seeking any waiver and the 

### estimated cost 

### to you (listed separately for each 

### data requirementandassociatedtest) of conductingthetesting neededto fulfill each ofthese data

### requirements. g. For each ofthe next ten years, a**year-b~year** 

### forecast ofcompany sales (pounds and 

### dollars) ofthe active ingredient(s), direct production costs ofproduct(s) containingthe active ingredient(s) (following the parameters 

### in item c above), indirect production costs ofproduct(s) containing the active ingredient(s) (fonowing the parameters 

### in item d above), and costs ofdata development pertaining to the active ingredient(s). h. A description ofthe importance and unique benefits ofthe active ingredient(s) to users. Discuss the use patterns and the effectiveness ofthe active ingredient(s) relative to registered alternative chemicals and 

### non-chemical control strategies. Focus on benefits unique to the 

### active ingredient(s), providinginformationthat

### isas quantitative as possible. Ifyou do not have quantitative data upon which to 

### base yourestimates,thenpresent the reasoning used to 

### derive your estimates. To assist the Agency in detenniningthe degree of importanceof theactive ingredient(s) intennsofits benefits, you should provide infOrmation on any ofthe following factors, as applicable 

### to your product(s): (1) 

### documentationofthe usefulness ofthe active ingredient(s) in IntegratedPest Management, (b) 

### description of the beneficial impacts on the environment ofuse ofthe active ingredient(s), as opposed to its registered

# •

•



# • IV. 

### alternatives, (c) information on

### the breakdown of theactive ingredient(s) after use and on 

### its persistence in the environment, and (d) description of its 

### usefulness against a pest(s) ofpublic health significance. Failure to submit sufficient information for the Agency to make a determination 

### regarding a request for a lowvolume minor use waiverwill result in denial of the request for a waiver. Low volume minor use waivers may not be available for data required for 

### continuationoftolerances or exemptions. 2. Request for Waiver ofData -Option 9 on the Requirement," 

### Status. and 

### Registrant's Response FOnD (Insert B). This option may be used if

### youbelieve that 

### a particular data requirement should not apply because the corresponding use is no 

### longerregistered and 

### no tolerance ortolerance exemption'exists ortherequirement is inappropriate. You must submit a rationale explaining why you believe the data requirements should not apply. You must also submit the current Jabel(s) 

### ofyoUT product(s) and, ifa current copy ofyout Confidential Statement ofFonnula is not already onfile you must submit a current copy. You will be informed ofthe Agency's decision in writing. Ifthe Agency determines that the datarequiremems ofthisNotice do notapply toyourproduct(s), you 

### will not 

### be required to supply 

### the datapursuant to section 3(cX2)(B) or section 

### 4(1)(1 XA). If 

### EPA deteoninesthatthedata 

### arerequired for

### yourproduct(sj. 

### you must choose a method ofmeeting the requirements ofthis Notice within the time frame provided by this Notice, Within 30 days ofyour receipt ofthe Agency's written decision. you must submit 

### a revised Requirements Status and Registrant's Re§POnse 

### .&um (Insert B) indicating the option chosen. CONSEOUENCes OF FAlLURETO CQMpL Y WIlliTHIS NOTICE A. 

### NOTICE OF IN'fElST TO SUSPEND REGISTRATION/ORDER REVOKING OR 

### MODIFYING TOLERANCE OREXEMPTION 

### The Agency may issue 

### a Notice ofIntent to Suspend products subject to thisNotice oranorderrevokingormodifyingassociatedtolerancesortoleranceexemptionsduetofailure 

### bya registranttocomplywiththerequlrementsof thisDataCall-InNotice, pursuant

### toFIFRA seetion 3(cX2)(B) orFFDCA section

### 408(1). Events which may be the basis for issuance of a Notice ofIntentto Suspend include, but are not limited to, the following: 

### 1. Failureto respond as required by thisNotice within 90 days ofyourreceipt of 

### this Notice. 2. Failure to submit on the required schedule an acceptable proposed orflnw protocol when such is 

### required to be submitted to theAgency for review. 3. Failure to submit on the required schedule an adequate progress report on a study asrequired bythis Notice.

# •

•



# • 4.
5.

6.
7. 8. Failure to submit onthe required schedule acceptable data as 

### required by this 

### Notice. Failure to

### take a required action or submit adequate informationpertainingto any

### option chosento address thedata 

### requirements (e.g.• any 

### required action 

### orinfurrnationpertainingto 

### submissionorcitationof existing studiesoroffers, arrangements, or arbitration on the sharing ofcosts orthe fonnation ofTask Forces, failure to comply 

### with the terms of an agreement or arbitration 

### concerningjointdata development or failure to comply with 

### any tenns ofa datawaiver). 

### Failureto submit supportable certifications as to the conditions ofsubmitted studies, as required by 

### Section Ul-C ofthis 

### Notice. Withdrawal ofan offer to share in the cost ofdeveloping required data. Failure of

### the registrant to whom you have tendered an offer to 

### share in the 

### cost ofdeveloping data 

### and provided proofofthe registranfs receipt of

### such 

### offer. orfail!Jre ofaregistrantonwhomyourely forageneric data

### exemption either to: a, inform EPA ofintent 

### to develop and submitthe data required by this Noticeona DataCalHnRe§pQnse Form (InsertA)and aRequirements

### Status and Registrant's Response

## Fonn (Insert B); or, b. fulfill the commitmentto develop and submit the data as 

### required by this Notice; or,
c. otherwisetakeappropriatestepsto meetthe requirements 

### stated inthis Notice. unless you commit to submit and do submit the required data in the specified time frame. 9. Failuretotake any required or appropriate steps, notmentioned above, at any time following the isSuance ofthis Notice. Events which may be the basis for issuance of an order revoking or modifYing associated tolerances or exemptions include. butare not limited 

### to, the following: I. Failureto respond asrequiredbythisNotice within 90 daysof yourreceiptof this Notice. 2. Failure to submit on the required schedule an acceptable proposed or 

### final protocol when such is required to be submitted 

### to the Agency for review. 

### 3. Failure to submit on the required schedule an adequate progress report on a study as required by this Notice.

# •

•



# • 4. Failureto submitonthe required scheduleacceptabledata as 

### required bythis 

### Notice. 5. Failure to submit supportable certifications as to the conditions ofsubmitted 

### studies. as required 

### by Section lll-C ofthis Notice. 6. Failure to take any required orappropriate steps, notmentioned above, at any time following the issuance ofthis Notice.


### B. BASIS FOR DEtERMrNAnON THAT SUBMIITED STUDY IS 

### UNACCEPTABLE TheAgency maydetermine that

### a study (even ifsubmitted within the required time) is

### unacceptableandconstitutes abasis forissuanceofaNoticeoflntentto

### Suspendoranorder revoking or modifying a tolerance or tolerance exemption. The grounds for suspension 

### include, but are not limited to, failure to

### meet any ofthe following: I. EPA requirements specified in the Data Call-In Notice or other documents incorporated by reference (including, as applicable, EPA Pesticide Assessment 

### Guidelines,DataReporting Guidelines, and GeneToxHealthEffects TestGuidelines) regarding the design, conduct, and reporting ofrequired studies. Such requirements include. but are notlimited to,thoserelatingto**testmateria~** 

### testprocedures, selection ofspecies, number ofanimals, sex and distributionofanimals, dose and effect levels to betestedorattained,durationof test, and, asapplicable,GoodLabonrtoryPractices. 2. EPA requirements regarding the submission of protocols, including the incorporation ohny changes required by the Agency following review. 3. EPA requirements regarding the reporting ofdata, including the manner of reporting,the completenessof reSUlts, andtheadequacyofanyrequired supporting (or raw) data, including, but not limited to, requirements referenced or included in this Notice orcontained inPR 86-5. All studies must be submitted in the form ofa final report; a preliminary report will not be considered to fulfill the submission requirement. C. EXlSUNG STOCKS OF SUSPENDED ORCANCELED PRODUCTS EPA 

### has statutory authority to pennitcontinued sale. distributionand use ofexisting stocks ofa pesticide product 

### which has been suspended or canceled ifdoing so would be consistent 

### with the purposes ofthe Federal Insecticide, Fungicide, and RodenticideAct. TheAgencyhas detennined thatsuchdisposition byregistrants ofexisting stocks for a suspendedregistrationwhenasection3{c)(2)(B)datarequestisoutstandingwould generally not be consistent with the Act's purposes. Accordingly, the Agency anticipates granting registrants pennission to sell, distribute, oruse existing stocks ofsuspended product(s) only

# •

•



# • in exceptional circumstances. Ifyou believe such disposition ofexisting stocks ofyour 

### product(s) whichmaybe suspendedforfailuretocomplywiththisNotice shouldbepennitted. you have the burden ofclearly demonstrating to

### EPAthatgranting suchpennissionwould be consistent

### withtheActYoumustalsoexplainwhy

### an "existingstocks"provisionis necessary, including asfatementofthe quantity of existing stocks and 

### yourestimate of the 

### timerequired fortheir sale,distribution, and use. Unless youmeetthis burdenthe Agency will notconsider any request pertaining to the continued sale, distribution, oruse ofyour existing stocks after suspension. !fyourequest avoluntary cancellation ofyourproduct(s) as aresponse to this Notice and your product is in 

### full compliance with 

### alI Agency requirements, you will have, under 

### mostciroumstances, oneyearfrom the date

### your90 

### day responsetothis Notice is due. to sell, distribute, or use existing stocks. Normally, the Agency will allow persons other than 

### the registrant

### suchas independentdistributors,retailersandend

### usersto sell.distributeorusesuch existing stocks until the stocks are 

### exhausted. Any sale, distribution or use of stocks of voluntarily canceled products containing 

### an active ingredient(s) for which the Agency has particular risk concerns will 

### be determined on case--by-case basis. Requests for voluntary cancellation**received~the**

### 90 day

### response period

### required bythis

### Notice will notresult in the Agency granting any additional time to sell, distribute. or use existing stocks beyond a year from the date the 90 day response was due unless you demonstrate to the 

### Agency that you are 

### in full 

### compliance with all Agency requirements, including the requirements ofthis

### Notice. For example. ifyou decide to voluntarily cancel your registration sixmonths before 

### a 3 

### year study is scheduled to be 

### submitted, all progress reports and 

### other infonnationnecessary to establish that

### you have beenconducting the study 

### in an 

### acceptable and 

### good faith manner

### must havebeen submitted to theAgency, before 

### EPA will 

### consider granting 

### an existing stocks provision.
SECTION V. REGISTRANTS' 

### OBLIGATION TO 

### REPORT POSSIBLE UNREASONABLE ADVERSE EFFECts 

### Registrants areremindedthatFIFRA section 6(a)(2) statesthatif

### at any timeafterapesticide is registered aregistrant has 

### additional factual informationregarding unreasonable adverse effects on the envirorunent by the pesticide, the 

### registrant shall submit the 

### information to the Agency. Registrants must notify the Agency ofany factual information they have. 

### from whatever source. includingbutnot limitedto interim 

### orpreliminary results ofstudies, regarding unreasonable adverse effects onman or the environment This requirementcontinues as long as the products areregistered by the Agency. SEcnON V!. INQUIRIES AND RESPONSES TQ THIS NOnCE 

### Ifyou have any questions regarding the 

### requirements and 

### procedures established by this Notice, call the contact person listed in 

### Attachment I, 

### the DataCall-In Chemical Status Sheet. 

### All responseS to this Notice (other than voluntary cancellation requests and generic data.

# •

•

• exemption claims)must include acompleted Da.ta**Call~ln** 

### Response Form (InsertA) and acompleted Requirements Status and 

### Registrant's Response Form (InsertB)and any otherdocuments required 

### by IhisNotice, andshould be submitted to

### the contactperson identified in 

### Attachment I. If the voluntary 

### cancellationorgeneric dataexemption option is chosen, only the DataCa!HnResponse Fonn (Insert A) need be submitted. 

### The Office ofCompliance (OC) ofthe Office ofEnforcement and 

### Compliance Assurance (OECA), EPA, will be monitoring

### the data 

### being generated in

### response to

### this Notice
.

# • • 

# •
Attachment 1 

### PENDING FLASHER SUMMARY
PRODUCT: DEF (tribufos) FLASHERNUMBER: 3077

. c',-,



## - , ";"ci' 

# ,';':i'**,.,-;~~~,** i!**"'.cr,';/~** 

# :;0- FLASHER ',.",



### -**DATK,;,;~':'l>:-"** -EPA 

# .§l!l;noJti 'l!¥n: ACTION' .'.. 

# ',;;,; OiJID1( _-NEEDED BY 

# - COMMENTS DATE 

### DEs'CRimoN '**REQ~-** ..,'.' 

## , .'( >. ' "" jI(Q''''' 

## ti1iL. ,,'**"",'~,** ", 

### 10131100 EPA 1) ProductSpecific 

### DCI for January 16 

### Included with 

### Interim Re-registration DataCall-In 

### 3125-282 DEF 6 

### 2001 Eligibility Decision Response 2) ProductSpecific

### DCI for 3125-96 DEF Technical 3) Generic DC! for 

### 3125-282 and 3125-96

General Comments: This IRED Generic Del 

### appears similarto 

### studies identified with 

### Preliminary RED.

### r--_ 

# e • 

# P. 1 of 

# 1 United States Environmental Protection Agency washington, D.C. 20460 DATA CALL-IN RESPONSE 

# -",.,.,..

QMII 110. 2(170-0107 21110-0057 Approv"l .><pI,"". niH/go UIS:r1I.ucrroNS, Pl
.... t.yp<'I <»:' print 1n ink. neU8**",*~d** carefully tha .ttubed u...t=ctiaruo
... 01 ""l'ply the inf
........ti_**noqllut~d** on lObi.• fon,. l1lIO
.. d<Ut!onal oIo•• t(.) if n.C
....1I%)' I..**~** ........ and Mdre... 003125 2. c..... , ;ond If

...... BAYER CORP 2145 DSF 

### AGRICULTURE DIVISION 8400 HAWTHORN RD BOX 4913 eII.odeal t .nd If_ 074801 Tri1nophQo

4. BPA Pl:oduct Roght,..ticn. 5. 1 wiub to "iUl"al thia pX'Odu"t ):'o¢av trat:lon voluntarily 5. <icn.ri" Data

, •. 1 aQ clai.ing a Qo;n_rlC Dabo**~Uon** bee_II.. 1: clot.in Che activa ing-redbnt forol> th. tiIOIIr.;:. IPA l:eliatraU.n nUllller li.hd 1><o1ov. '10. I**~H.** to .. they a.narlo Ooota requi.,."..,nt.
.. indicated on tk.**att~~a** for. antithd "li:"quinR<lnts St_tllU ""01**~'etront·.** R
...

pan•••• 3. Data and 1yp
.. of Del GENERIC

7.**~X'Odu"t** !petifi" Dah 7
... My pJ<Odu<:t h an**"U~** 

### ..,a I**~e** 1:0 aati.fy til
.. IIUl nquino
....nt. on tk•• ttack.d fOJ:ll entitled 'RequiX'ellenta "tatu. and**~i.t:rant'a** hap<mn." 710. IIy proc\lIct i8 an IWP ond 1 I'Igree 1:0 uthfy tho IIUP J:'O<fIIi):'.......,ta on tIIa att_<;:h.d fo"" entithd ·1I.6<l\liroaellu Stat". and.**R~.l:rant·a** R08p<l1\U."

## i;];;-k~~&jt~;;''f''X't}_1+~':;p;fP;Vf-''~t-~",wryB,'\'i'iJ*k;;';¥.f$-(:f;:S-;:JWt~d11:z:t~}?X~j7ltii!,"(J~f'j«ii£rg:}'II-~~;~J$iF,:.msj\1W»')w;r-(;q.$;)~(0;k~4'~,Y4';jh<1'~i'i$f':"'Ai§!t~%fSt~?0'A;;;~~j,:::'7i*~1i~lirif ",Q;
....**4";;L/~'Glii!i:·'_t>,'*-'-"."'0'"****~:;m,,~=!"''%'it',wA:*'-'%A'i<;,**.. _""",,," , ..,_, .', .0>.0>,,,_, ''''" ,**"ld'~"~''''"-''''. ,'li'tESSiLiW.Si~J:WJi®W)Iii\%~,"""**  __**~"** 0,,,",**~~** __ h**e,,-".~~**

## ..,**,,~ol'** 

## .,..**~'"'**

## __=.**_~:r~~\i"-;M~:m,~** ,.,,(

TX81004500**y~**

,. cortifieaUon 1I. !hot

.. l Certify that th

...**tat_~nt**..... da em thi. fOJ:ll ..,d all "ttechaent I acknowlO>dge th"t any lo;;nowin!J1y f;l.1•• or 

### "'d
..l-ding .t&t"""nt or both undO>r .pplicabla law. C Klren S. Cain signatun ""d T1tl
.. of COOIl'any'.**Auth<>rl,,~d** !t.p"-,:,nnt
..t1v,, Re ul tor Afflirs Manlger January 25. 2001 10. U

... _ of eo..pany O<x:oloaet: n· Phon." lfWOb.r MirY K. McKinney**816~242-2S39**

# • United States Environmental Protection Agency Washington, D.C. 20460 RBQUIRKIIJi:N'rS STA'l'D'S Am) RBGISTltAHT' S U:SPONSJl

1. c.::..pany ........ _Ii Ad<b:<tu BAYER CORP 

### AGRICULTURE DIVISION 8400 HAWTHORN RD BOX 4913

<t.**GI.Iid<olu.~** Requil:'<llll"nt 

# "'""«

>0. $. Study Tid
.. 

### 003125 Z. C;a
.." • _Ii tra"" 2'145 

### DEF**Chnrl<:~** t IUId N

... Tribup/>o<J
". u... 

# I,**~** i • 

# I,·teem

y y 

### 074801

1 eartify th"t tlla "U.Cement
..... de "n thh fer» and. dl attaclm.."ttt ar<I t:tWII, IlCC"'r&t., and """",1
..to. Z**.~l**..dg. I:hn ;my knowingly fal

.... OX lllid
....ding
..C.Cnent**~** be puniehal>h by fin
.., i;

.. ,prl
.......lIflt or both WIde" Hl'plical>h h,... ./. 

### I/"":.,. Karen S. Cain 7. Te
..t 

# ""'.-**"~~F**

and Titl" of CoIopany'" Auchorl:d Regulatory Affairs Manager
12. 1<
.... of eo..pany**Ccn~""t ~ary**  K. McKinney**~** 'en! "P!;>ro"
..d OMe )to, 2070-0107 2070-0057 AJ>prov"l**~:lrIII. 12/31/~O** 

l. Oau. and'fYp<o of oor 

### GENERIC

B. Ti_ 

# ..-**~~** ,.**R~9';;gtnnt** Ru"",n

...

January 25, 2001**~I>on.**

# _r
816-211-2-2539

# •**~** 

# P. 1 

### of 1 

# " United States Environmental Protection Agency Washington, D.C. 20460 

## * COHIIIiW%S POR GUIJ)BLINB RBQUrRBlllD1"1'S
Cag" I and x...... 2145 

### DEF eb".ical • '"'1d
_ 

### 074801 

### Tribuphos**GaIDIlr.I~ -.~**  ,

. 72-4 (a) 

### Two**stud~es** 

### requ1red: 1. 

### Freshwater early life stage with the rainbow trout. 2. 

### Estuarine, marine early life stage study with sheepshead minnow. 72-4 (b) 

### Mysid is the preferred species 171-4 (d) 

### ILV of 

### milk 171-4(k) COTTON 

### Crop field trials for Ultra-Law-Volume (ULV) 

### applications.

# • 

# • • p <<< 0 f • V4 

## • united States Environmental Protection Agency 

### Washington. D. C. 20460 LIST OF ALL REGISTRANTS SENT THIS DATA CALL- IN NOTICE 

### case # 

### and Name: 2145 

### DE' Co. 

### Nr. Company Name Additional Name Address City &. 

### State 

### Zip 

# """ AVENIIS CROi>SCIEIiCE USA LP Z ToW.**AL£XAII~ER** DRIVE RESEARCH TRIANGLE PARK 

# "'09 1)03125 BAfEk CORP AGRICULTURE DIVISIOlI &\00 NAWTIIORN HD 10K 4913 KANSAS CITY tIO**6~120** 051036 HICRO-FLO co BOX 

### nz(W9 HEMPHIS TN 38117

# Attachment 2

# Bayer CropScience
September 17,2010 

### Ms. Molly Clayton Risk Management and Implementation Branch III Pesticide Re..evaluation Division (7508P) Document Processing Desk (DCIIPRD) Office ofPesticidal Programs U. S. Environmental Protection Agency One Potomac Yard 2771 South Crystal Drive Arlington, VA 22202-4501 Subject: Tribufos Registration ReviewData**Call~In** 

### 90-Day Response 

### Data Call-in ID # RR-074801-30045 Case#2145DEF Dear 

### Ms. Clayton: Enclosed with this coverare two fonns required 

### by the 90-day response due 

### for the generic data call-in issued by 

### the EPA for tribufos. aayerCropSclanc:e P.O. Box 12014 2T. W. Alexander Drive Re$earch Triangle Park, NC 2n09



### Bayer CropScience has divested this active ingredient to 

### Amvac Chemical Corporation (EPA 

### Company Number 5481). Accordingly, the registrations ofDEF Technical Defoliant (EPA Registration Number 264-720) 

### and DEF 6 

### Emulsifiable Defoliant (264-730) 

### were transferred to Amvac. Copies ofthe letters sent to 

### notify the Agency ofthis transfer are appended to this cover. Bayer CropScience has notified Amvac that the Agency has issued adata call-in for tribufos and provided them with 

### a copy ofthe DCI. It

### will be the responsibility ofAmvac to provide their response to the data call-in. Ifyou have questions regarding this request or require additional information. please contact me. Sincerely.

Paul A. Cain, Ph. D. Director, Herbicide & 

### PGR Registrations Phone: (919) 549·2582 e-mail: paul.cqln@/wwrqropsclmce.C9l!.I



### cc: Mr. Jon 

### Wood, Amvac Chemical CorporationPage 1of 1 

### [lniIcd States Environmental Protection OMU '\JlJlrllw2!l70-OIfl7 

### Agency \\lusbington. D.C. 20460 OMB Appc
..vaJ, 1071-0174 DMB**Apl'f<)~alllmr·III)~7**

DATA CALL-IN RESPONS[ INSTRUCTIONS: Plea&c Iypo cr plint in ink. Pklase toad carafulty Ifle aUacbed instrudicn5 ilnd supply the inforrT\illlcn requested on ttli:l torm. Use additional "heel(s) ifnea!'s,u), I. Comp<lny Name

.. rod Mt:lless 2. Cast! "and**Nam~** 3. Date and Type of DCt and Number BAYER CROPSCIENCE LP 2145 DEF 16-Aug-2010 2 TW. ALEXANDf.RORIV," ChffilK:A1 # and Name 074801 GENERIC RESEARCH TRIANGLE; PARK. NC 2770$ Tribuphos ID" RR-074B01..J0045 4. liPA 5. Iwish ro 6. Genl!ric Dalll 7. Product Specific Dala Pn;>dud c:i'lncetlhl$ Regi:llration prodL>C! regis- Ba. I am daiming a Generic Sb. I IO!jreeto satisfy Genllric 1'10. My product i$ an MUP ilnO 7b. MJ"pwdU<;fiSiln£;UPlind jrn\ion vo/un· Data Exemplion becaU!;fl! I**O~tilllXIuifem!i!nl$** as indicated I agree to satisfy too MUP I ;Igmo 10 $atisfy Ilia EUP lariy cbtain Ihe aetiYelDgr(ldienl on Ille attached foon entitled requiremenls on the**~ached** reqI.MI'efllenl5 on Ifle attached from the SOUIl.le EPAt!!9is- 'Req<liremet'll$ Status and fonn enli!led "Requimmants form**ant~led** ·Requireme"ts. uation numbor istw'below.**Reg/stran~s Respons~** " Slalus and Regl,wl'lnt":s Statusand Regl&tranrs Response." Respt'lllse." 2l>4-72JJ NA NA.

Il. Certincalion I cerlil)rllult lhe stillt!ments. made OnUlIsform OIfld .!lI.ltilchmllfrts are tfLle. ao::urale. and complele. I al)knllWlodgl! that any 9. OQtc knowingly fill$(! Q' misfeooing $Uiromcnl**m~y** ceo punisbacle**c~** fj"e.**i'.'Jlpriso~menl** orboth under**.lI~~~** law.

# -Pa September 17. 2010 , . Registration Manager Her 

### lCldes**~** SIg"ab.JrG and Title ofCompany's**Aulhor~ed** Rt!pre$entatwe • • HI. N.vnC 01 Ccrnpilny 

### BayerCropScience 11. Phont! Nilmt>er 

### 919-549-2582

-- -------**~,.~**...------.--..- 

## --_._-Pag_1 of 1 

### United States Eovironmental Protection OMBAppro''''**~07(Hl!** (11 

### Agency Washur.gton. D.C. 20460 

# o.ao. App:!'Oval207t-0114 (iMH AJIlIl'tIl':ll**~I)jU.oo~7** REQUIREMENTS STATUS AND RF.GlSTRANT'S RESPONSE INSTRUCTIONS; Please type \If print inink.. Please read care1ulIy 11t\l at!iiChClf in3!rudlOn$ and &uppq- lhe information lequested Qfllhl$ f\lrm. U.w 3t1diI,o""1 ,t>eel(9) if**n~**..'Y
I. C\lmpanyNElmeaIltlMO're5; 2_ Case'and Name 3. Dale and**T~e** of DC! and Number SAYER CROPSCIENCE lP 2145 DEF 18-Aug-2010 2 T.W. AlEXANDER DRIVE Ghemk:i!l1t aM Name 074801 GENERIC RESEARCH TRIANGLE PARK. NC 27709 Tribuphos 10# RR-074801-30045
4. Guldeine -5_ SwdyTiUe p 11. Use 7. Te$. 6. Time S. RI:gLStran! R Prog!bS$ -Roquiremenl D RcpC/t$ Pattern Sub5bnce F_ Respa!)Se Number T (Mooths) D 

### c D L 

# , 2 3 §nvll'onmental Fah;! om**~uiremenls** jC(lnvenliona! C**1l~.4:JOO** Aerobic; "'lu.aljc metabolism 

### HH TGAJ or PAIRA 

# "**5~.6200** Aqull!i:: field (!Is'iipali\ln 

# tJ, HH TEP 18 Tlffle!lrial i!nd Bgumlc NS!!Ui!!!!I!!tQ!lIl!nl$!!!$ Dali! R<t9uirn!!l!!rU fC9nventillnaI Ch,mican 500.2100 Allian flCU(eJ Ofafloxicily 1$$1 {:1.6} 

### HH TGAl, TEP 12 550.173:1 WII\lle sedimeJ1l. aeule freshw"!\N" inveJlebraies 

### HH TelA! 12**B5Q.17~0** WIw1\l $\!O'Jim.mt a<;\.IIe marine inverwbrille:i 

### HH TGA! 12 Toxicol9gy Dilta Rtgyfmmefll${C\lnventio!!!l Chemjca!) 670-.7800 !mml.m\ltol\lclty (1) 

### HH TGII, 12

Speeb! Siudy TCffe$lf\a1 PI,lnl Toxicity To« (2.4) 

### HH TEP 2.

10. CcrlillcaliOl'l ! eerlifl' thilllhe 5191ement\! made orr 1111$ rCl'm and

..**~** .;ol!achmenl$ are !rue, accurl:lte, and ct>rnplete. ! iM;know!edlle !lIal a"y 

# " D,. knowingly fll/se or mi$leadfng s.tatemel'll may be p-unl,nabJe byfine, lmptlsanmanl \II balli u/ldlef applicable- ItIw

# .pc7~ September 17,2010 Signawl'll and Tille \l'I C\lmpanfS**Auth<lri~ed** RepresentallYe 

### RegistratiDn Manager, Herbicides 12. NameofCompany 

### BayerCropScience 13:. Phone Numl.x!r 

### 919-549-2582Koy: Uni1ed States .Envirorunenlw Pnltcclinn Agency Washingf(lfl. D.C. 20460 FOOTNOTESAND KEY DEFINITIONS FORGUIDELINE REQUIREMENTS <:asc # and Name: 2145 DEF Dcr Number:**RR-07~801-30045** Fage1of1

TEP =Typlcal End Use PrO/JvCl ITEP}; rG

.... J=**T~lllcal** GraGe: AcIIve: lngrel:ilent [fOAl]; TGAl, TEP**~ T~l'!nical**  Graue o/theActlYa lntcgredient orTel;:l'!nieal End·Use Product; H;A,1 or PA1RA;- Tectmleal Grade**ortheAeti~** lngtl!!dient orA,cWe Ingredient. Radio-labelled

Ua Catellones KtIY: HH

- Oc;:.upatio:mlll O.$e Convenlional

Footnotes; (l'hQ following Ilor.s aM**~''''llCad** III <;olumR two (i, Study File) 01the REQV1ReMfNTS STATUS AND REGISTRANT'S RESPONSE form.} Prot\')Cfll musl be approved by thll Agency before the stLldy is**ini~a!ed.** 2 l


# ,



# , 6 Protoeol must be approved bytheAgqncybetore the sJudy Is Inillilled. An envfronment31 cnemlstry Ill\rtllc(l ilnd associated inaependlllU laboraroryvalldation IortrilHlfos resldues ofooncem In water and in &ediment.llle required. An entire aqw.lic field diuipaliQrl 3tudy [$ nol requrred. lWaUabic toxic.lty studies for lnbufu$**~re** not $u!ficiontly**rob~** bllCilUlle, th.**telffl~trWil** planld31a pce..wuslysubmil!Rd arE 011 pllll'lt spades (I.e., annual dlCOls and monOQotl) lhat are not qxpecled to be as :II.lnaitive ttl tri>ufQs ail' okpl,u'lts (e.g

.. waody ck:cIduous trees and stlWt)$) d[,le to 1m. mechanism or aCUOn.**Ava~able** loxit«y .$Wdie:!iwere conouclecl On plilnls that do no!. 101m <lbsci$$1on**Z(I~5,** and4ata tIOm these**$\lIdi~** nl$)' unaeW$limato tl!e potenHai toxicityoflribulos to nOll·lllfBet plants1hRt do fonn abscission ;rone$.I:FA**~eds** additiQnill tene:;lriGlpl\lnt toxicity S\udiO$ no pJanti cxpeGle.:i to be**sens~iwe** to ffihufo$' mOde of action so thatlheAgency can property as.sess po:>l.ential fisk to plants. Data required tor pooserine specieS only. Prctoeol must be 9pprQved by theAJ.lellCY b810lllthe stucty Is inilated.Co.Hr. 

# "'" Company NMne Unih.'ti StateS EllviroruneHtal Protc..>c1ion Agency Wasllington, D.C. 20460 LIST Of<' ALL REGISTRANTS SENTTHIS DATA CALL-IN NOTICE Caso:f.llnd**Namo~** 214$,DEF Aglilflt**~r** Address BAYER CROPSCIENCE lP PO BoK 120142 T.W. ALEXANDER DRIVE**City&Sta~** RESEARCH TRIANGLE PARK Zip NC2nCQ

# Attachment 3

### UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, DC 20460**~s. ~argaret(jlerny**  

### BayerCropScience LP 2T,W, Alexander Drive, P.O. Box 12014 Research TrianglePark, NC 27709 Dear

### Ms. Cherny; October 06, 2010 

### Office of Prevention, Pesticides and Toxic Substances



### Pursuantto 

### your data

### transfer request dated June 30,2010. and subsequem: information received, we have approvedthe transfer ofdata ownership from Uayer ( ropScience, company number 264, to Amvac Chemical Corporation d/b/a!Amvac, company number 5481. The 

### data transfer is effective as ofthe date ofthis letter. After

### this date, AmvacChemical Corporation 

### d/b/a! 

### Amvac company number 5481 will 

### be considered the data owner. We note that 

### no exclusive use was transferred with 

### any ofthis data. Please keep this letter in 

### your records as the EPA does Dot 

### track ownership ofdata 

### in ourdatabase. This letter signifies the new ownership. This action will not automatically bereflected onthe Data SubmittersList, Ifyou wish to be added to the 

### Data Submitters List. you must submit an additional requestto: DocumentProcessingDesk (DSL) Office ofPesticidePrograms (7504P) 

## U.s. Environmental ProtectionAgency Ariel Rios Building 1200 PennsylvaniaAvenue, NW Washington, DC 20460-0001 By copy ofthis letterwe are informing

### the transferor ofthese changes. 

### Ifyou have any questions about this transfer approval, please call Louis Vaughn at (703) 308-8114,

• hief onnati rvices Branch

cc: Mr. Jon 

### C. 

### Wood ormation Technology and Resources ManagementDivision, 

### (1504P)

Amvac Chemical Corporation 4695 MacArthur Court, Suite 1250 Newport Beach, CA 92660- 1706

### cc: Ms. 

### Meshea Brodie Bayer CropScience LP 2 T.W. AlexanderDrive, P.O. Box 12014 Research Triangle Park, NC 27709



### 2

# Bayer 

# CropScience

List ofDataTransferred from Bayer CropScience LP 

### to Amvac Chemical Corporation

? 0.. 8c.( j.z:;14 "F. Lt: 2770c T.;:I. 91£'**~,,,,::,** :<':33MRID· 86110
120773
112739
113993

87411

87412

87413

87414

87415

87416

87417

87418 Page 2 of 18
Study Title Exclusive Use Mobay Chemical Corporation (19??) DEF Defoliant (Formerly B-1776). (Unpublished**~dY** received Dec 17, 1959 under 3125-EX-53; CDL:233108-A 

### No Mobay Chemical Corp. (1960) DEF Residues in Cottonseed. (Compilation; unpublished studyreceived Apr20, 1960 under unknown admin. no.; CDL:120081-A)
. 

### No Mobay Chemical Corp. (1968) DEF: Analytical and Residue Infonnation 

### on Cotton. (Compilation;**~)PUbliShed** study received May 2, 1968 

# ""d" 9F0737; CDL:091271-A 

### No Mobay Chemical Corp. (1 %8) Study: DEF Residue in Cotton. (Compilation; unpublished study received Dec 23, 1968; Dec 27, 1968; Doc 24, 1968 under 9F0737; CDL:093048-B) 

### No Mobay Chemical Corporation (1968) Supplementto Synopsis ofAnalytical andResidue Information on DEF on Cotton: SupplementNo. I. Summary of studies 091270-8 through 091270-E. (Unpublished study received Jan 18, 1969 under9F0737; CDL:091270-A) 

### No Livennan, J.L. (1957) Report ofStuciies Carried Out at College Station, Texas, in the Fall of1957, Using Phosphorus-32 and Sulfur-35 LabelIedDEF: (Submitter) 2202. (Unpublished studyreceived Jan 18, 1969 under9F0737; prepared by TexasA & M Univ., submitted byMobay Chemical Corp., Kansas City, Mo.; CDL:091270-B) 

### No Chemagro Corporation (1968) The Effect ofFrozen Storage at 0 to -10"0 F. onDEF"{R) Residues in Cottonseed: Submitter Report No. 23123. (Unpublished study received Jan 18, 1969 under 9F0737; submitted by Mobay Chemical Corp., Kansas City, Mo.; CDL:09127O-C) 

### No Miller, C.S.; Aboul-Ela, M.M. (1968) Absorption of-S-, -S-, -S-- tributylphosphorotrithioate by cotton leaves. Journal ofAgri- cultural and Food Chemistry 16(6):946-949. (Submitter 23857; also--In-unpublished submission received Jan 18, 1969 under 9F0737; submitted by Mobay Chemical Corp., Kansas City, Mo.; CDL091270-D) 

### No Olson, T.1. (1968) A Confirmatory Procedure for the Gas Chromatographic Analysis of"(R) DEF Residues in Cottonseed: Report No.23867. (UnpUblished study received Jan 18, 1969 under9F0737; submitted by Mobay Chemical Corp., Kansas City, Mo.; CDL:091270-E) 

### No Mobay Chemical Corporation (1959) Synopsis ofPharmacological and Toxicological Information on DEE Summary ofstudies 091270-0 through 091270-1. (UnpubliShed study received Jan 18, 1969 under9F0737; CDL:091270-P) 

### No Murphy, S.D.; DuBois, KP. (1959) Toxicity and anticholinesterase activity oftributyl phosphorotrithioate (DEF). American Medical Association Archives ofIndustrial Health 20(Aug): 161-166. (Submitter4242; also--In-unpublished submission received Jan 18, 1969 under 9F0737; submitted by Mobay Chemical Corp., Kansas City, Mo.; CDL:091270-J) 

### No Mobay Chemical Corporalion (1968) Supplement to Synopsis ofPbannacological and ToxicolOgical Infonnation on DEF: Supplement No.1. Summary ofstudies 091270-Mthrough 091270-U. (Unpublished study received Jan 18, 1969 under 9F0737; CDL:091270-K) 

### No

Bayer**CropSci'inc~,** P.O. 80:< 12014, Research Triangle Park, North CaroUn<l 27709 Tel. 919 549-2000 Submission Date 12/1711959
412011960
512/1968
12123/1968

111811969

1/18/1969 

# I i'1'1811969 

# I

, 

# r------, I ,
, 

# I I 1/1811965

1118/1969

1/18/1969

1/18/1969

11181196987420

87421

87422

87423

87424

87426

87427

87428

116531

45983
114023 Page: 3 of 18 DuBois, KP. (1964) The Acute Toxicity ofTwo Samples of S,S,s. Tributyl Phosphorothioate to Adult, Female Rats: Submitter 14565. (Unpublished study received Jan 18, 1969 under 9F0737; prepared by Univ. ofChicago, Dept. ofPharmacology, submitted by Mobay Chemical Corp., Kansas City, Mo.; CDL:091270-M) 

### No**Doul~** 1.; Root, M. (1965) Subacute Oral Toxicity ofDEF to Male and Female Dogs: Submitter 16422. (UnpubJishedstudyrecelved Jan 18, 1969 under 9F0737; preparedby Univ. ofChicago, Dept. ofPharmacology, submitted by Mobay Chemical Corp., Kansas City, Mo.; CDL:091270-N) 

### No Harris, L.E. (1965) Report on Demyelination Studies on Hens: DEF: Submitter 16614. (Unpublished study received Jan 18, 1969 under 9F0737; prepared by Harris Laboratories, Inc., submitted byMobay Chemical Corp., Kansas City, Mo.; CDL:091270..o) 

### No Root, M.; Taitel, C.; Doull, J. (1965) Subacute Oral Toxicity of DEFto Male and Female Rats: Submitter 16823. (Unpublished study received Jan 18, 1969 under 9F0737; prepared by Univ. of Chicago, Dept. of**Phannacolo~p)ubmitted** by Mobay Chemical Corp., Kansas City, Mo.; CDL:091270-P 

### No Dubois, K.P.; DiGiacomo, R; Root, M.; etaI. (l966) The Subacute Dermal Toxicity ofTributy1Phosphorotrithioate (DEF) to Rats: Submitter 19563. (Unpublished study received Ian 18, 1969 under 9F0737; preparedby Univ. ofChicago, Toxicity Laboratory, submitted by Mobay Chemical Corp., Kansas City, Mo.; CDL: 091270-Q) 

### No Hibbs, C.; Nelson, D.L. (1917) Chronic Oral Toxicity ofDEF to Male and Female Rats: 20462. (Unpublished study received Jan 18, 1969 under 9F0737; submitted by Mobay Chemical Corp., Kansas City, Mo.; CDL:091270_S) 

### No DuBois, KP.; Root, M.; DiGiacomo, R.; et aJ. (1967) Effect ofDEF in the Diet on the Reproduction and Lactation on Mice: Submitter 21543. (Unpublished studyreceived Jan 18, 1969 under 9F0737; preparedby Univ. ofChicago, Toxicity Laboratory, submitted by Mobay Chemical corp., Kansas City, Mo.; CDL: 091270-1) 

### No DuBOis, KP.; Root, M.; Meskauskas, I.; et aI. (1967) Chronic Oral Toxicity ofDEF to Male and Female Dogs: Submitter 21556. (UnpUblished study received Jan 18, 1969 Wlder 9F0737; prepared by Univ. ofChicago, Toxicity Laboratory, submitted by Mobay Chemical Corp., Kansas City, Mo.; CDL:091270-U) 

### No Church, D.; Shaw, H. (1970) DEF--Leaching, Runoff; and Batch Ad sorption 

### on Soils: Report No. 26,292. (Unpublished study received Feb 3, 1970 under 9F0737; submitted by Mobay Chemical Corp., Kansas City, MO; CDL:093048-A) 

### No Crawford, 

### C.R. (1971) Treatment Studies for A(R) DEF Intoxication: Report No. 30093. (Unpublished study received Jul19, 1971 under WlknOwn admin. 

### no.; submitted by Chemagro Corp., Kansas City, Mo.; CDL:I03419-A) 

### No Mobay Chemical Corp. (1971) Efficacy Data: DEF
. (Compilation; unpublished study received Iul27, 1971 under unknown admin. no.; CDL:126853-A)
. 

### No

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49238 Page 4 of 18 Ivey, IL.;Anderson, AL.; Cathey, G.W.; et al. (1973) 

### "CR.) DeE Biological Perfonnance ofUltra-low Volume Applications for Defoliation ofCotton and Dilute Spmys for Defoliation ofRank Cotton. (Unpublished study received May7, 1973 under3125-71; prepared in cooperation with U.S. Agricultural Research Service, DeltaStates Agricultural Research Center, Cotton Physiology Research Laboratory and Univ. ofMississippi, Truck Crops Experi- ment Station, submitted by Mobay Chemical Corp., Kansas City, Mo.; CDL:094767-A) 

### No Chemagro (l973) DEF: The Effects on the Environment: Surrunary of Toxicity Data**~)(UnpubIiShed** study received May 7, 1973 under 3125-71; CDL:007020-A 

### No Howell, J. (19??) Toxicity ofCbemicals: Submitter 11144. (Unpublished study received May 7, 1973 under 3125-71;preparedby U.S. Fish and Wildlife Service, Bureau ofCommercial Fisheries, Hammond Bay Biological Station, submitted by Mobay Chemical Corp., Kansas City, MO; CDL:007020-B) 

### No Walker, C. (1963) Chemical Toxicity to Fish: DEF: Submitter 12947. (Unpublished study received May 7, 1973 under 3I25-71; prepared by U.S. Fish and Wildlife Service, Fish Control Laboratory, submitted by Mobay Chemical Corp., Kansas City, MO; CDL: 007020-D) 

### No Marking, L. (l967) Concentrations Producing All-or-none Effects on 

# , Preliminary Basis at 24 Hours and 12C: Various Chemagro Compounds : Submitter 17363. (Unpublished study received May 7, 1973 under 3125-71; prepared byU.S. Fish and Wildlife Service, Fish Control Laboratory, submittedby Mohay Chemical Corp., Kansas City, MO; CDL:007020-G) 

### No U.S. Fish and Wildlife Service (1966) Bio-assay Screening Test: DEF Defoliant: Submitter 21338. (Unpublished study received May 7, 1973 un:I.er3125-71; preparedby 

### U.S. Bureau ofCommercial Fisheries, Biological Laboratory, submitted by Mobay Chemical Corp., Kansas City, MO; CDL:007020-I) 

### No Lamb, D.; Jones, R. (1972) Acute Oral Toxicity ofDEFTechnical to Bobwhite Quail and Mallard Ducks: Report No. 35016. (Unpublished study received May 7, 1973 under 3125-71; submitted by Mohay Chemical Corp., Kansas City, MO; CDL:007020-0) 

### No Lamb, D.; Jones, R. (1972) Toxicity ofDEF 6 Lbs/Gal Spray Concentrate to Bobwhite Quail and New Zealand Rabbits Applied under ULVSimulated Field Conditions: Report No: 35030. (Unpublished studyreceived May 7, 1973 under 3125-71; submittedby Mobay Chemical Corp., Kansas City, MO; CDLO07020-P)

. 

### No Mobar Chemical Corp. (I968) SupplementNo.1 to Brochure Entitled:**DEF-~Aoa1ytical** and Residue Infonnation. (Compilation; unpublished study received Mar 22, 1976 under 3125-71; CDL: 224115-A) 

### No Mobay Chemical Corporation (1973) Supplement to Synopsis of Phannacological and Toxicological Information ofDEF. Summary ofstudies 224109-C througb 224109-1. (Unpublished study received Mar22,1976 under 3125-71' CDL:224109-A) 

### No DuBois, 

### K.P.; Meskauskas, 

### 1. (1968) The Acute InhalationToxicity 

### or. DEF Fonnulation to Mice: Report No. 23805. (Unpublished study received Mar 22, 1976 

### under 3 125-71; prepared byUniv. of Cbicago, Toxicity Laboratory, submittedby Mobay Chemical Corp., Kansas City, Mo.; CDL:224109-C) 

### No

BayerCropSclence, P.O. Box 1:<:014. Rosearch Triangle Park. North Carolina 27709 Tel. 919 549-2000 SnJI973

5nJI973

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SnJ1973

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Crawford, C.R. (1971) Thc Eye and Dennal Irritating Properties of '(R) DEF 6 LbsiOal Spray Concentrate to Rabbits: Report No. 30814. (Unpublished study received Mar 22, 1976 under3125- 71; submitted by Mobay Chemical Corp., Kansas City, Mo.; CDL: 224109-D) 

### No Ben-DYke, R.; Sanderson, D.M.; Noakes, D.N. (191?) Acute toxicity data for pesticides (1970). Pages 119-127, in (Withouttitle). N.P. (Submitter report no. 31765; also in unpublished submissionreceived Mar 22, 1976 under 3125- 71; submitted by Mobay Chemical Corp., Kansas City, Mo.; CDL:224109-E) 

### No Crawford, C.R.; Anderson, R.H. (1972) The Acute Oral Toxicity ofDEF"(R) (Special) 6 Ibslgal Spray Concentrate to Rats: ReportNo. 33127. (Unpublished study received Mar 22, 1976 under3125-71; submitted by Mobay Chemical Corp.,Kansas City, Mo.;CDL: 224109-F) 

### No Kimmerle, G.; Lorke, ? (1972) DEF ULV 6 LbJGal. S.C.: Acute Inhalation Toxicity: Report No. 3487; Repnrt No. 34161. (Unpublished studyreceived Mar22, 1976 under 3125-71; prepared by Farbenfabriken Bayer, AG, submjttedbyMobay Chemical Corp., Kansas City, Mo.; CDL:2241 09-0) 

### No Crawford, C.R; Anderson. R.H. (1972)The Acute Dermal Toxicity of '(R) DEF UL V to Rabbits: Report No. 34480. (Unpublished studyreceived Mar 22, 1976 under 3125-71; submittedby Mobay Chemical Corp., Kansas City, Mo.; CDL:224109-H) 

### No Crawford, C.R.; Anderson, R.H. (1972) The Skin and Eye Irritation Properties of"(R)DEF Teclmical to Rabbits: Report No. 35006. (Unpublished study received Mar22, 1976 under 3125-71; submit ted by Mobay Chemical Corp., Kansas City, Mo.; CDL:224109-I) 

### No Mobay Chemical Corporation (1971) Addition to Synopsis ofDEF: Biological Performance ofUltra-lowVolumc Applications forDefoliation of Cotton and Dilute Sprays for DefoliationofRank Cotton. (Reports by various sources; unpUblished study includingpublished datareceived Mar22, 1976 under 3125-71; CDL:224110-A) 

### No Mobay Chemical Corporation (1973) Additionto Synopsis ofDEF: Biological Performance ofUltra-low Volume Applications for Defoliation of Cotton and Dilute Sprays for DefoliationofRank Cotton. (Reports by various sources; unpublished study received Mar22, 1976 under3125-71; CDL:224111-A\ 

### No Mobay Chemical Corporation (19721) Synopsis ofthe Effects ofDEF on the Environment Summary ofstudies 224109-F, 224114-B through 2241 14·E, 224114-0 through 224114-M and 224114-0 through 224114-Q. (Unpublished study received Mar 22, 1976 under 3125- 71; CDL:224114-A) 

### No Synek, J. (1973) Effects ofDEF 6 SC on Auto Paint Panels: Report No. 36214. (UnpUblished studyreceivedMar 22, 1976 under 3125. 282; submitted by MobayChemical Corp., Kansas City. MO; COL: 232397-B) 

### No University ofCalifornia, Agricultural Extension Service (19??) Toxicity of Pesticides and Other Agricultural Chemicals to Honey Bees: Field Study. Riverside, Calif.; UC, ACES. (AXT-251; submitter reportno. 21052; also in unpublished submissionreceived Mar 22, 1976 under 3125-71; submitted by Mobay Chemical Corp., Kansas City, Mo.; CDL:224114-I) 

### No Bureau ofCommercial Fisheries Biological Laboratory (1966) Bioassay Screening Test: ReportNn. 21338. (Unpublished study; CDL:224114'J) 

### No Church, D.D.; Shaw, H.R., 

### n (1970) DEF-Leaching, Runoff, and Batch Adsorption on Soils: ReportNo. 26292. (Unpublishedstudy received Mar 22, 1976 under 3125-71; submitted by Mobay Chemical Corp., Kansas City, 

### No B3yer CropSc1ence, P.O. Box 12014, Research Triangle**Par~,** North Carolll1i1 2IT09 Tel. 919 549-2000 3/2211976

3122/1976

3122/1976

3122/1976

312211976**13.t:~:/1976** 

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49395 Page 6 of 'IB Lamb, D.W.; Roney, D.J. (1972) Acute Toxicity ofDEF"{R) 6 LbslGal Spray Concentrate to Fish: Report No. 33400. (Unpublished study received Mar 22, 1976 under 3125-71; submitted by Mobay Chemical Corp., Kansas City, Mo.; CDL:224114-0) 

### No Lamb, D.W.; Jones, R.E. (1972) Acute Oral Toxicity of"(R) DEF Technical to Bobwbite Quail and Mallard Ducks: Report No. 35016. (Unpublished study received Mar 22,1976 under 3125-71; submitted by Mobay Chemical Corp., Kansas City, Mo.; CDL:224114-P) 

### No Lamb, D.W.; Jones, R.E. (1972) Toxicity of"(R) DEF 6 Lbs/Gai Spray Concentrate to Bobwhite Quail and New Zealand Rabbits Applied under ULVSimulated Field Conditions: Report No. 35030. (Unpublished study received Mar 22, 1976 under 3125-71; submitted by MobayChemical Corp., Kansas 

### city, Mo.; CDL:224114-Q) 

### No Synek, J. (1973) Physical Properties ofVarious Chemagro Fonnulatiorul Used as ULVand LV Sprays: Report No. 29727. (Unpublisbed study rcceived Mar 22, 1976 under 3125-282; submitted by Mobay Chemical Corp., Kansas City, MO; CDL:232397-D) 

### No Mobay Chemical Corp. (1969) Supplement No.2 to Brochure Entitled: DEF: Analytical and Residue InfonnatiOn on Cotton: Document No. AS76-334. (Compilation; unpublished study received Mar 22, 1976 under 3125-71; CDL:223877-A) 

### No Thornton, J.S.; Anderson, C.A. (1966) Gas chromatographic detennmation of residues ofS,S,S-Tributyl phosphorotrithioate in cottonseed and cottonseed oil. Journal ofAgricultural and Food Chemistry 14(2): 143-144. (Submitter rept. no. 18021; reprint; also in unpublished submission received Mar 22, 1976 under 3125-71; submitted by Mobay Chemical Corp., Kansas City, Mo.; CDL:224112-D) 

### No Cbemagro Corporation (1968) Synopsis ofAnalytical and Residue Infonnation on DEF on Cotton. Summary ofstudies 224112-B, 2241 12-C, 2241 12-E and 224112-G through 224112-K. (Unpublished study received Mar22, 1976 under 3125-71; submitted by Mobay Chemical Corp., Kansas City, Mo.; CDL:224112-A)
. 

### No Thornton, J.8. (1965) AGas Chromatographic Method for the Determination ofResidues ofDEF in Cottonseed and Cottonseed Oil: Report No. 15,306. Method dated Feb 2, 1965. (Unpublished study received Mar 22, 1976 under 3125-71; submitted by Mobay Chemical Corp., Kansas City, Mo.; CDL:224112-B) 

### No Chemagro Corporation (1967) (Efficacy ofDEF on Cottonseed): Report No. 15546. (Compilation; unpublished study including reportnos. 15547, 15548, 15549
..., received Mar 22, 1976 under 3125-71; submitted byMobay Chemical Corp., Kansas City, Mo.; CDL:224112-C) 

### No Thornton, J. (1966) Detennination ofResidues ofDEF in Soil by Thermionic Emission Gas Chromatography: Report No. 18713. (Unpublished study received Mar 22, 1976 under 3125-71; submitted by Mobay Chemical Corp., Kansas City, Mo.; CDL:224112-E) 

### No Chemagro Corporation (1966) (Efficacy ofDEF in Soil): Report No. 19320. (Compilation; unpublished study including report nos. 19321. 19421 and 19422, received Mar 22, 1976 under 3125- 71; submitted by Mobay Chemical Corp., Kansas City, Mo.; CDL: 224112-F) 

### No

Bayer CropSclence, P.O. 80x 1:1014, Research Triang!e ?ilrk, North COIrol!na 2170tl Te!. tl1tlS49-20QO 312211976

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80037 Page 7 of 18 Thornton, I.S. (1967) Determination ofDEF Residues in Animal Tissues by Tnennionic Emission Flame Gas Chromatography: Report No. 21367. Method dated Nov 6, 1967. (Unpublished study received Mar 22, 1976 under 3125-71; submitted by Mobay Chemical Corp., Kansas City, Mo.; CDL:224112·G) 

### No Thornton, I.S. (1967) Determination ofDEF Residues in Milkby Tnermionic Emission Flame Gas Chromatography: Report No. 21369. Method dated Nov 6,1967. (Unpublished study received Mar 22, 1976 under 3125-71j submitted by Mobay Chemical Corp., Kansas City, Mo.; CDL:224112-H) 

### No Thornton, 1.S. (I968) A Gas Chromatographic Method for the Determination ofResidues ofDEF in Cottonseed and Cottonseed Oil Employing Thermionic Emission Flame Ionization Detection: Report No. 21794. Method dated Ian 29, 1968. (Unpublished study received Mar 22, 1976 under 3125-71; submitted by Mobay Chemical Corp., Kansas City, Mo.; CDL:224112-I) 

### No Thornton, 1.S. (1968) Effect ofthe Oil Deodorization Process on DEF Residues in Cottonseed Oil (Simulated): Report No. 21888. Method dated Feb I, 1968. (Unpublished study received Mar 22, 1976 under 3125·71; submitted by Mobay Chemical Corp., 

### Kansas City, Mo.; CDL:224112-1) 

### No Harris, L. (I965) Report on Demyelination Studies on Hens [DEF]: Rev. Unpublished Mobay report 15948 prepared by Harris Laboratories, Inc. 4 p. 

### No Thyssen, I,; Schilde, B.; Kimmerle (1976) DEF: Neurotoxicity stud- ies on Dermally Treated Hens: ReportNo. 6255. Unpublished study prepared by Bayer AG. 17 p. 

### No Thyssen, 1.; Schilde, B. (1976) DEF: Neurotoxicity Studies on Hens (Inhalation Experiments): Report No. 6444; Report No. 50952. (Unpublished study received May 23, 1977 under 3125·96; prepared by Farbenfabriken Bayer, AG, West Germany, submitted by Mobay Chemical Corp., 

### Kansas City, Mo.; CDL:231493-A) 

### No Thyssen, I.j Wechsler, W.; Schilde, B. (1977) DEF: Neurotoxicity Studies on Hens: Thirty-day Feeding Experiments: Report No. 6941. Unpublished study prepared by BayerAG. 39 p. 

### No Thyssen, 1.; Mohr, U. (I976) DEF: Neurotoxicity Studies on Hens: Report No. 5948. Unpublished Mobay report 47932 prepared by BayerAg and Medizinische Hochschule Hannover, Abteillung fuer Experimentelle Pathologie, W. Ger. 21 p. 

### No Francisco (l9??) Pulmonary Exposure ofMice to DEF. Unpublished study. 6 p. 

### No Root, M.j Mcskauskas, J.j Doull, 1. (1967) ChronkOral Toxicity ofDEF to Male and Female Rats. Unpublished Mobay report 20462 prepared by Univ. ofChicago, Toxicity Laboratory. 18 p. 

### No Thyssen, I.; Schilde, B.j Lorke, D. (I978) DEF, Studies ofSubacute Denn,! Neurotoxic Effects on Poultry: Report No. 8081j 67075. (UnpUblished study received Aug 21, 1981 under 3125-282j prepared byBayer AG, West Gennany, Submitted by Mobay Chemical Corp., Kansas City, Mo.; CDL:245780·A) 

### No Thyssen, 1.; Lorke, D.; Mohr, U. (1978) DEF: Subacute Inhalation Study on Rats: Report No. 7649; 66435. (Unpublished study received Aug21, 1981 under 3125-282; preparedby BayerAG, West Germany, submitted by Mobay Chemical Corp., Kansas City, Mo.j CDL:245782-A) 

### No

Bayer CropScience, P.O. Box 12014, Research Triangle Pari" North Carollna 21109 Tel. 919 549-2000 3/2211976

3/2211976

3/2211976

3/2211976
9/9/1976 1213011976

5/23/1977 

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151229 151230 Page 8 of 18 Thyssen, 1.; Schilde, B.; Lorke, D. (1978) DEF: Neurotoxic Effects on Poultry (Subacute Inhalation Study): Report No. 7614; 66480. (Unpublished study received Aug 21, 1981 under 3125-282; preparedby BayerAG, West Germany, submitted by Mobay Chemical Corp., Kansas City, Mo.; CDL:245781-A) 

### No Mobay Chemical Corporation (19??) Pulmonary Exposure ofMice to DEF"(R) : 54054. (Unpublished study received Sep 10, 1981 under 3125- 282; CDL:24651 I-B) 

### No Lapadula, D.; Carrington, C.; Abou-Donia, M. (1984) Induction of hepatic microsomal cytochrome P-450 and inhibition ofbrain, liver, and plasma esterases by on acute dose ofS,S,S-tri-n-butyl phosphorotrithioate (DEF) in the adult hen. Toxicology andAppJied Pharmacology 73:300-310. 

### No Mobay Chemical Corp. (19??) [DEF Residue Data]. Unpublished compilation. 39 p. 

### No Thornton. 1;Pither, K. (1978) ALaboratory Study with DEF: Report No. 65025. Unpublished study prepared by Mobay Chemical Corp. 6 p. 

### No Leimkuehler, W. (1980) DEF Water Solubility at 20 [Degrees} C and 30 [Degrees} C: 68926. Unpublished study prepared by Mobay Chemical Corp. 4p. 

### No Peoples, S.; Maddy, K.; Datta, P.; et al. (1981) Monitoring ofPotential Exposures ofMixer-loaders, Pilots, and Flaggers during Application of Tributyl Phosphorotrithioate (DEF) and Tributyl Phosphorotrithioite (Folex) to Cotton Fields in the Sanloaquin Valley ofCA in 1979: Rev. HS-676. Unpublished study prepared by CA Dept. ofFood and Agriculture, Div. of Pest Mgrnt., WorkerHealth and**Sa~tyUnit. 3~** ..p. 

### No Osbima, R.; Mischke, T.; Gallavan, R (1980) Drift Studies from thc Aerial Application ofDEF and Folex in Fresno and Merced Counties, CA 1979. Unpublished study prepared by CA Dept. ofFood and Agriculture. Mobay No. 68795.**5~_** 

### No Hermann, B. (19??) Atmospheric Residues ofthe Defoliants DEFFolex, and Their Sulfur-containingByproducts near Treated CottonFields. Unpublished dissertationprepared for requirements for the degree ofDoctorofPhilosophy in the Graduate Division ofthe Univ. ofCA, Davis. Mobay No. 69201, 209 p. 

### No Kendall, D. (1981) Letter sent to D. Flint dated luI 10, 1981: Summary report: Laboratory studies ofthe potential odor contribution ofDEF-6. Prepared by ArthurD. Little, Inc. MobayNo.69685. 7p. 

### No Thyssen, 1. (1978) DEF: Studies on Acute Inhalation Toxicity (Rats): 80-T014: ReportNo. 7636. Unpublished Mobay ReportNo. 66481 prepared by BaverAG.**~** 

### No Abou-Donia, M. (1978) Study ofthe Low Level Effects ofOrgaJ;loph08phorus Esters with Specific References to the Delayed Neurotoxic Syndrome: Quarterly Report4: Effect ofa Single Oral Dose and Subchronic (90-day) Oral Administration ofTechnical DEF to Adult Hens. Unpublished study prepared by Duke University Department ofPhannacology. "35 p. 

### No Abou-Donia, M. (1979) Late acute effect ofS,S,S-tributylphosphorotrithioate (DEF) in hens. Toxicology Letters (4): 231-236. 

### No Wilson, B.; Cisson, C.; Randall, W.; et 

### at. (1980) Organophosphate risk assessment: Field tcsting ofDEF with the scaleless chicken. Bull, Environnl. Contam. Toxicol. (24):921-928. 

### No

BayerCropSc[encc, P.O. Box 12014. Rtsellrch Triangle- Park. North Carolina 21109 Tel. 919 549·2000 8121!i981

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Abou-Donia, M.; Graham, D.; P.;_et al.**.t~?:~_**Delayed neurotoxic and late acute effects ofS,S,S-tributyl the hen: Effect ofroute ofadministration. No <?raham, D.;**Ab~;~**K.;**et~. ~1;79?:**  I,,, effects

### :-'1' Subchronic . . h"". No H'y", K.'**tS~dyon.~,** 

### :L

# '~J1

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### D~F~._ study prepared ChemiCal No McGreevy, 1.; Swan, J.; Modrcin,**~._~l** ofDEF 6 and DEF8

_

# :~slifiable**,~~c::::;~: ~nter~af~;~:**  33 p.90183. Unpublished No

# ~~~~:-~J-'n-butyl**P~:~~horotrithioat~ ~~** **~~:!3~~~~~h:~~~t:~~dof** phosphatase, and 2,3'-cyclic nucleotide-3' phosphohydrolase and plasma butyrlcholinesterase in hens: ReportNo. 88977. P. 499-502 inElsevier Science Publishers B.V.- Development inthe Science and Practice of No " R.

# "~par~~~~ Miles

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Clemens, G.; Bare, 1.; Hartnagel, R. (1987) Teratology Study in the Rab,b,it with DEF Technical: Rt .,. 

### N

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# "'''eO< .•,100. 120 p. No

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Curren, R. (1990) UnscheduledDNA Synthcsis in Rat Primary Hepatocytes: Lab ProjectNumber: T8299.380: 1107. Unpublished study prepared by Microbiological Assoc., Inc. 26p. 

### No Putman, D.; Morris, M. (1989) Chromosome Aberrations in Chinese Hamster Ovary (CHO) Cells: Lab ProjectNumber: T8299.337: 98592. Unpublished study prepared by Microbiological Assoc., Inc. 28 p. 

### No Toll, P. (1990) Mobay Corporation Phase 3 Summary ofMRID 00049258 and Related MRIDs 00120771. Acute Oral Toxicity ofDEF Tcchnical to Bobwhite Quail and Mallard Ducks: Reference No. 72-35; Report No. 35016- 1. Prepared by Chemagro Div. ofBaychem. 12 p. 

### No Toll, P. (1990) Mobay Corporation Phase 3 Summary ofMRID 40757101. A One-generation Reproduction Study with the Bobwhite (Colinus virginianus): WlLProjectNo.149-127. Prepared by Wildlife International Ltd
.. 16 p. 

### No Sheets,1. (1990) Mobay Corporation Phase 3 Summary ofMRJD 00049244. The Skin and Eye: Irritation Properties ofDEF Technical to Rabbits: Project: 72-38 (MobayReport 35006). Prepared by Mobay Corp
.. 7 p. 

### No Cluistenson, 

## w. (1990) Mobay CorporationPhase 3 Summary ofMRID 41171001. Oncogenicity Study with Technical Grade Tribufos (DEF) with Mice: Project: 86-271-01 (Mobay Report 99175). Preparedby Mobay Corp
.. 

### 25p. No Eigenberg, D. (1990) Mobay Corporation Phase 3 Summary ofMRID 40190601. A Teratology Study with DEF in the Rat: Project 8536 (Mobay Report 87320). Prepared by:M1les Laboratories, Inc. 27 p. 

### No Eigenberg, D. (1990) Mobay Corporation Phase 3 Summary ofMRlD 40190602. Teratology Study in the Rabbit with DEF Technical: Project 8605 (Mobay Report 94468). Prepared by Miles Laboratories, Inc
.. 34p. 

### No Van Goethem, D. (1990) Mobay Corporation Phase 3 Summary ofMRlD 41459101. SahnonellaIMammalian-Microsome Plate Incorporation Mutagenicity Assay (Ames Test), DEF Technical: Project T8299.501 (Mobay Report 98575). Prepared by Microbiological Associates, Inc. 8 p. 

### No Van Goethem, D. (1990) MobayCorporation Phase 3 Summary ofMRID 41459103. Chromosome Aberrations in Chinese Hamster Ovary (CHO) Cells, DEF Technical: Project T8299.337 (MobayReport98592). Prepared by Microbiological Associates, InC. 9 p. 

### No Van Goethem, D. (1990) Mobay Corporation Phase 3 Summary ofMRlD**4145~1**02. Unscheduled DNA Synthesis in RatPrimary Hepatocytes, DEF Technical: ProjectT8299.380 (Mobay Report 98576). Prepared by Microbiological Associates, Inc. 8 p. 

### No Mobay Corporation (1990) Reregistration Phase 3 Response: Tributyl phosphorotrithioate. Correspondence and SupportingMaterial. 

### No Talbott, T. (1990)Product Chemistry ofDEFTechnical: Lab Project Nwnber: VAP0007: JDM0066; 2172. Unpublished studyprepared by 

### Mob.yemp. 65 p. No Talbott, T. (1990) Product Chemistry ofDEFTechnical: Lab ProjectNumber: 9197&: 99857: 99856. Unpublished study prepared by Mobay Corp. 115 p. 

### No Talbott, T. (1990) Product Chemistry ofDEF Technical: Lab ProjectNumber: 90606: 94500: 94682. Unpublished study prepared by Mobay Corp. 29 p. 

### No Grau, R. (1990) DEF Technical Grade; 5-dayDietary LC50 to Bobwhite Quail: Lab Project Number: BV-007: E2950351-5: 100223. Unpublished studyprepared by BayerAg. 36p. 

### No

Bayer CropScience, P.O. Box 1:/:014, RMe::m:h Triangle Park, North**C~rollna** 27709 Tet. 919 5'49·2000 411911990

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Grau, R (1990) DEF Technical Grade: 5-day Dietary LC50 to Mallard Duck: Lab ProjectNumber: VE-002: E2970426-0: 100224. Unpublished studyprepared by Bayer Ag. 43 p. 

### No Grau, R (1990) DEFTechnical Grade: Acute Toxicity to Bluegill Sunfish in a Flow-through Test: Lab Project Number: FB-003: E2860137: 100222. Unpublished studyprepared by 8ayerAg. 36 p. 

### No Grau, R. (1990) DEF 6: Acute Toxicity to Bluegill Sunfish in a Flow-through Test: Lab ProjectNumber: FB-006: E02860355-9: 100219. Unpublished studyprepared by Bayer Ag. 40 p. 

### No Grau, R (1990) DEF Technical Grade: Acute Toxicity to Rainbow Trout in a Flow-throughTest: Lab Project Number: FF-286: E2810136-1: 100221. Unpublished study preparedby 8ayerAg. 36 p. 

### No Grau, R. (1990)DEF 6: Acute Toxicity to Rainbow Trout in a Flow-through Test: Lab project Number: FF-228: E2510429: 100220. Unpublished study preparedby 8ayerAg. 39 p. 

### No Heimbach, F. (1990) mfIuence ofDEF Technical on the Reproduction Rate of Water Fleas: Lab ProjectNumber: HBFIRDM29: E3210393-1: 100235. Unpublished studyprepared by 8ayerAg. 56 p. 

### No Cohle, P. (1990) Uptake, Depuration and Bioconcentration of{Carbon 14)- DEF by Bluegill (Lepomis macrochirus): LabProject Number: 38466: 100236. Unpublished studyprepared by Analytical Bio- Chemistry Laboratories, Inc. 48 p. 

### No Sheets, L. (1990) Dennal Sensitization Study with Technical GradeTribufos (DEp) in Guinea Pigs: Lab,ProjectNumber: 90-324-GK: 100268. Unpublished studyprepared byMobay Corp. 24 p. 

### No Hughes. 1. (1990) The Toxicity ofDEF Technical to Selanastrum capricomutllm 

### (ner2 Growth and Reproduction ofAquatic Plants): Lab ProjectNumber: 8059-02-2: 100230. Unpublished study prepared by Malcolm Pirnie, mc. 36 P. 

### No Schocken, M.; PbiIippson, 1. (19B7) Stability ofDEF in Sterile Aqueous Buffer Solutions: Lab Project Number: 94918. Unpublished study prepared by Mobay Corp. 23 p. 

### No Kesterson, A.; Lawrence. L. (1990) Solution Photolysis of Carbon 14 DEF in Natural Sunlight: Lab Project Number. 1154: 205: 99730. Unpublished study preparedby Phannacology and Toxicology ResearchLaboratory. 41 p. 

### No Jackson, S.; Kesterson, A.; Lawrence, L. (1988) Soil Surface Photolysis of Carixm 14 DEF inNatural Sunlight: Lab ProjectNumber: 1153: 206: 95673. Unpublished study prepared by Pharmacology and Toxicology Research Laboratorv. 67 D. 

### No Daly,.D. (l987) Soil Adsorption/Desorption with Carbon 14 -DEF: Lab Project Number: 36356: 95600. Unpublished study prepared by Analytical Bio-Chemistry Laboratories, Inc. 50 p. 

### No Cohle, P. (l990) Uptake, Depuration andBioconcentration of{Carbon 14)- DEF by Bluegill (Lepomis Macrochirus): Lab Project Number: 38466: 100234. Unpublished study prepared by Mobay Corp. 45 p. 

### No Heimbach, F. (989) Acute Toxicity ofDEF (Technical) to Waterfleas (Daphnia magna): Lab ProjectNumber: 99630. Unpublished study prepared by BayerAG. 32 p. 

### No Heimbach, F. (l990) Acute Toxicity ofDEF 6to Waterfleas (Daphnia magna): Lab Project Number; HBF/DM96: E 320 0403-2: 100208. Unpublished studyprepared by Bayer AG. 33 p. 

### No Bayer CropScience, P.O. Box 12014. Research Triangle Park, North**Caro/J~a** :<n09 Tel. 919 549-2000 9/4/1990
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Carpenter, M. (1990) 'Detennination ofthe Aqueous Photolysis Rate ofDEF': Lab ProjectNumber: 38876. Unpublished study prepared by Analytical BioChemistry Laboratories, Inc. 41 p. 

### No Warren"D. (1990) Acute Four-Hour Inhalation Toxicity Study with Technical Grade DEP in Rats: Lah ProjectNumber. 90-042-HQ. Unpublished study prepared by Mobay Corp. 33 p. 

### No Ward, G. (1991) DEF: Acute Toxicity to The Mysid, Mysidopsis bahia, Under Flow-Through Test Conditions: Lab Project Number: J900802- 4B: 101245. Unpublished study prepared byMobay Corp. 45 p. 

### No**Gagli~o,** G. (1991) Acute Toxicity ofDEF Teclmical to the Sheep-Shead Mirmow (Cyprinodon variegatus) UndcrFlow-Through Conditions: Lab ProjectNumber: DE83 1201 : 101240. Unpublished study prepared byMobay Corp. 31 p. 

### No Sheets, L.; Fuss, M. (1991) Primary Dermal Irritation Study with Technical Grade Tributos (DEF) in Rabbits: Lab Project Number: 90-325-FS. Unpublished study prepared by Mobay Corp. 16 p. 

### No Pauluhn, J. (1991) DEF; Tribufos; Tribufate: Range-Finding Study of the Subacute Inhalation Toxicity to Rats (Exposure: 10 x 6h): Lab Project Number: 100695: 91-T-036: 19903. Unpublished study prepared by Bayer AG. 212 p. 

### No Sheets, L.; Phillips, S. (1991) Acute Dermal Toxicity Study with Technical Grade Tribufos (DEF) in Rabbits: Lab ProjectNumber: 90-025-FE: 100698. Unpublished study preparedby Mobay Corp. 20 p. 

### No Sheets, L. (1991) Acute Oral Toxicity Study with Technical Grade Tribufos (DEF) in Rats: Lab ProjectNumber: 90-012-ES: 100697. Unpublished study preparedby Mobay Corp. 20 p. 

### No Sheets, 1.; Phillips, S. (1991) 2 I-Day Dermal Toxicity Study with Technical Grade Tribufos (DEF) in Rabbits: Lab ProjectNumber: 90-125-FP. Unpublished study prepared by Mobay Corp., Toxicology Dept. 445 p. 

### No Sheets, L. (1991) Subchronic Delayed Neurotoxicity Studywith Technical Grade Tribufos (DEF) in Hens: Lab ProjectNo: 89-428-CS. Unpublished study prepared by Mobay Corp., Toxicology Dept. 189p. 

### No Christenson, W. (1991) Chronic Feeding Toxicity Study ofTechnical Grade Tribufos (DEF) with Dogs: Lab Project Number: 88-274-AB. Unpublished studyprepared by Mobay Corp., Toxicology Dept 585 p. 

### No Stevenson, T.; Leimkuehler, W.; Mathew, A. (1991) The Metabolism of Tribufos in Soil UnderAerobic Conditions: Lab Project Number : DE042101: 100338. Unpublished study prepared by Mobay Corp., R&D Dept. 33 p. 

### No Stevenson, T.; Leimkuehler, W. (1990) The Metabolism ofTribufos in Soil Under Anaerobic Conditions'. Lab ProjectNumber: 100333. UnpUblished studypreparedby Mobay Corp., R&D Dept. 31 p. 

### No Schmidt, J.; Head, 1. (1991) Anaerobic Aquatic Metabolism of[carbon 141- Tribufos: Lab Project Number: 39232: 101322. Unpublished study prepared by ABC Laboratories, Inc. 62 p. 

### No Kao, M.; Middien, R.; Bosnak, 1.; et al. (1991) Dispositionand Metabolism of Carbon 14 ·Tribufos in Rats: Lab ProjectNumber: 101331: DE041801. Unpublished study prepared by Mobay Corp. 145 p. 

### No Hall, L. (1991) The Metabolism of Carbon 14 and S 35 -Tribufos in Hens: Lab ProjectNumber: DE04050 I: 101329. Unpublished Studyprepared by Mobay Corp. 123 p. 

### No
Bayer CropScience, P.O. SOl( 12014, Ro!)search Triangle Park, North Carolina 27709 Tel. 919 549·2000 12/10/1990

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### Y. (199I) Metabolism of Carbon 14 ·Tribufos in Lactating Goats: Lab ProjectNumber: DE041001: 10 1330. Unpublished study prepared by 

### Mob.y 

## e"p. 83 •• No Eigenberg, D.; Elcock, L. (1991) A Two-Generation Reproduction Study in Rats Using Tribufos (DEF): Lab ProjectNumber:**88~71-** AK. Unpublished study preparedby Mobay Corp. 1025 p. 

### No Eigenberg, D. (1991) A Dietary Reproductive Toxicity Study Investigating the Fertility ofFl Rats Using Terbufos: Lab Project Number: 89-971-DC. Unpublished study prepared by Mohay Corp. 60 p. 

### No Eigenberg. D. (1991) A Cross·Fostering Study in Rats using Tribufos (DEF) Administered in the Diet: Lab Project Number: 88·971-BZ. Unpublished study prepared by Mohay Corp. 116 p. 

### No Wheat, J.; Ward, G. (1991) DEF Teclmical: Acute Effect on New Shell Growth of, The Eastern Oyster, Crassostreavirginica: Lab Project Number: 101959: J9008024C. Unpublished study prepared by Toxikon Environmental Sciences. 53 D. 

### No Leimkuehler, W.; Moore, K. (1991) Carbon 14 Tribufos Residues in Confined Rotational Crops: Lab ProjectNumber: DE05160 I. Unpublished study prepared by Mobay Corp. 37 p. 

### No Sheets, L.; Phillips, S. (1992) Primary Dermallnitation Study with DEF 6 in Rabbits: Lab Project Number: 9l-325·MG. Unpublished study prepared by Miles Inc. 28 p. 

### No Christenson, W. (1992) Technical Grade Tribufos (DEF): A Chronic ToxicitylOncogenicityl Neurotoxicity Feeding Study in the Fisber 344 Rat: Lab ProjectNumber: 88-271·AA. Unpublished study prepared by Miles Inc. 3672 p. 

### No Talbott, T. (1987) Henry Constant ofDEFPure Active Ingredient. UnpUblished study prepared by Mobay Chemical Corp. 5p. 

### No Krolski, M.;Bosnak, L. (1992) Additional Characterization ofMetabolites from the Disposition and Metabolism of[l-carbon 14! Tribufos in Rats: Lab Project Number: DE041801: 101331-1. Unpublished study prepared by Miles' Inc. 22 P. 

### No Schroeder, R. (1992) Dermal Absorption ofTribufos by Rats from a DEF 6 Emulsifiable Fonnulation using [carbon 14! Tribufos: Lab ProjectNumber: 91-722·KW. Unpublished study prepared by Miles, Inc, 54 p. 

### No Schocken. M.; Parker, G. (1987) Leaching ofAged Soil Residues ofDEFin California Sandy Loam: Lab Project Number: 95016. Unpublished study prepared by Mobay Corp. 23 p. 

### No Grace, T.; Cain, K. (1990) Dissipation ofTribufos in California Soils: Lab Project Number: ML022101: 89. 022: 892010. 1·5K. Unpublished study prepared by Plant Sciences, Inc.; Siemer and Associates, Inc. and PTRL West. 66'-1>, 

### No Erhardt·Zabik, S.; Torralba, 1.; Nishioka, L.; etal. (1989) Development ofan Analytical Method for DEF and DibutyldisulfideResidues in Soil: Lab projectNumber: DE 122101: 147W. Unpublished study prepared by PTRL West. 35 p. 

### No Grace, T. (1990) Freezer Storage Stability ofTribufos and Dibutylsulfide in Soil: Lab ProjectNumber: DE830089ROI: 100157. Unpublished study prepared by PTRL West. 83 p. 

### No Chopade, H. (1992) Metabolism of[n·Butylthio-l-carbon 14! Tribufos in Cotton: Lab ProjectNumber: DE41601: 102639. Unpublished study prepared by Miles, Inc. 87 p. 

### No BayerCropScience, P.O. Box 12014, Research Triangle Park, North Carolina 27709 Tel. 919 549-200n 9126/1991
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Hall,1. (1992) The Metabolism of{Carbon 14) and (Sulfur 35) Tribufos in Laying Hens: Lab ProjectNumber: DE040501: 101329-1. Unpublished study prepared by Miles, Inc. 158 p. 

### No Sabali. Y.; Jett, C. (1992) Metabolism of[l.carbon 14! Tribufos·in Lactating Goats: LabProjectNumber: DE041001: 101330-1. Unpublished study prepared by Miles, Inc. 114 p. 

### No Gronberg, R.; Murphy, 1, (1992) Requirements for Animal Residue Methods, Animal Feeding Studies, andMeat, Milk and Egg Tolerances for Tribufos: Lab ProjectNumber: 103201. Unpublished study prepared by Miles, Inc. 24 p. 

### No Fontaine, 1. (1992) Supplement to MRID 41618803: Product Chemistryof DEF Technical: Lab Project Number: BR 1804. Unpublished study prepared by Miles Inc. 6 p. 

### No Pauluhn, J. (1992)DEF (Cornmon Name: Tribufos); Study ofthe Subchronic Inhalation Toxicity to Rats in Accordance with OECD Guideline No. 413: Lab ProjectNumber: 102697. Unpublished study prepared by Bayer Ag, Wuppertal, Germany. 1050 p. 

### No Astroff. A. ; Phillips, S. (I992) Experimental Acute Oral Toxicity Study with HBM Sulfone (a Metabolite ofTribufos, DEF) in Female Rats: Lab Project Nwnber: 92-912-OD. Unpublished studypreparedby Miles, Inc. 18 p. 

### No Christenson, W. (1992) Technical GradeTribufos (DEF): A Chronic Toxicity/ OncogenicityiNeurotoxicity Feeding Study in the Fischer 344 Rat: A Supplement: Lab Project Number: 88·271-AA: 102675·1. Unpublished study prepared by :Miles, Inc. 183 p. 

### No Sheets, L.; Phillips, S. (1992) Acute Oral Toxicity Study withDEF 6 in Rats: Lab ProjectNumber. 92..(112·NO: 102678. Unpublished study prepared by Miles Inc. 22 p. 

### No Astroff, A.; Phillips, S. (1992) Acute Dermal ToxiCity Study with DEF 6 in Rats: Lab Project Number: 92-022·NZ: 102679. Unpublished study prepared by Miles Inc. 22 p. 

### No Warren, D.; Tran, A. (1992) Acute Four·HourInhalation Toxicity Study with DEF 6 in Rats; Lab Project Number. 91·042·MD: 102669. Unpublished study prepared by Miles Inc. 35 p. 

### No Eberhart, D. (1993) Evaluation ofWorker Exposures to Tribufos During Aerial and Ground Applications ofDEF 6 to Cotton: Lab ProjectNumber: DE202301: 103889. Unpublished study prepared byMILES, Inc. 334p. 

### No Eberhart, D.; Ellisor, G. (1993) Evaluation ofWorkerExposure to Tribufos During Harvesting ofCotton Treated with DEF 6: Lab Project Number; DE202302: 105103. Unpublish.ed study prepared by Miles Inc. 307p. 

### No Bajzik, M, (1992) The Independent Laboratory Method Validation for the Analysis ofTribufos in Cottonseed and Soapstock: Lab ProjectNumber; DE 111601: 105003. Unpublished study prepared by Huntingdon Analytical Scrvices. 90 p. 

### No Gronberg, R; Sanders, D. (1993) An Improved Analytical Residue Method for the Determination ofTribufos in Cottonseed and Cottonseed Processed Products: Lab Project Number: AOI2.004; DElI1603: 105026. Unpublished study preparedby Huntingdon Analytical Services and :Miles Inc. 126 p. 

### No Gronberg, R; Sanders, D. (I993) A Registered Product Interference Study for the Analytical Residue Method for Tribufos in Cottonseed and Cottonseed Processed Products; Lab Project Number; DEI4160I; 105178. UnpUblished study prepared by Miles Inc. 131 p. 

### No Bayer Cl'QpSci1'!nce-, P.O. Box 12014, Research Triangle Park, North Carolina 21709 Tel. 919 549-2000 6/1111992

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# !' Page 15 of 18 Gronberg, R.; Sanders, D. (1993) Extraction Efficiency of the Analytical Residue Method for Tribufos in Cottonseed: Lab Project Number: DEI I 1602: 105179. Unpublished study prepared by Miles Inc. 21 p. 

### No Zorbas, M. (1993) Dermal Sensitization Study with Technical Grade Trebufos (DEF) inGuineaPigs: Lab ProjectNumber: 90·324·GK: 100268·1. Unpublished study prepared by Miles, Inc. 9 p. 

### No Zorbas, M. (1993) Primary Dennal Irritation Study with Technical Grade Tribufos (DEF) in Rabbits: Lab Project Number: 90-325·FS; 100694·1. Unpublished study preparedby Miles, Inc. 8 p. 

### No Leimkuehler, W.; Moor, K. (1993) Identification and Characterization of Radioactive Residues of(carbon 14) Tribufos in Bluegill Sunfish (Lepomis Macrochirus): Lab ProjectNumber: DE040301. Unpublished studyprepared by Miles Inc. 84 p. 

### No Valadez, S.; Dehart, B.; Cain, K. (1993) Field Dissipation of Tribufos on Georgia Soil: Lab ProjectNumber: DE02210 1: 105163: 52373. Unpublished study prepared by Miles Research Farm; Miles Research Park; and Harris Environmental Technologies, Inc. 81 p. 

### No Hatfield, S. (1993) Field Dissipation ofTribufos on Georgia Soil: Supplemental Data: Lab ProjectNumber: DE022101: 105163/1: 52373. Unpublished study prepared by Harris Environmental Technologies, Inc. 3740. 

### No Rogen;, W. (1993) Field Dissipation ofTribufos on Georgia Soil: Supplemental Data: Lab Project Number: DE022101: 10516312. Unpublished study prepared by Miles, Inc. Research Farm. 287 p. 

### No Schmidt, J. (1994) Anaerobic Aquatic Metabolism of(Carbon 14) Tribufos: Lab Project Number: DE042402: 106767. Unpublished study prepared by ABC, Lab., Inc. 61 p. 

### No Grace, T. (1995) DEF 6EC-Magnitude ofResidue in Cotton Processed Products: LabProject Number: DEI9CTOI: 106988. Unpublished study prepared by Miles Research Park and Bayer Corp. 405 p. 

### No Mathew, A.; Nguyen, T. (1995) Tribufos··A 28-Day Dairy Cattle Feeding Srody: Lab ProjectNumber: 107104: DE06040 1: DE130401. Unpublished study prepared by Bayer Corp. 508 p. 

### No Krolski, M. (1995) DEF 6EC-Magnitude ofthe Residue on Cotton: Lab ProjectNwnber: 106993: DEI9CT02: 351·DEOO 1-94D. Unpublisbed study prepared by Bayer Corp. 542 p. 

### No Gronberg, R.; Sanders. D. (1995) An Analytical Residue Method for the DetenninationofTribufos Residue in Animal Tissues and Milk: Lab Project Number: 107068: DEI20201. Unpublished study prepared by Bayer Corp. 320. 

### No Warren, D.; Meier, M. (1996) Dennal Sensitization Study with DEF 6 in Guinea Pigs: Lab ProjectNumber: 107182: 95-324-EJ. Unpublished study prepared by BayerCorp. 25 p. 

### No Murphy, 1. (1996) (Carbon 14) Tribufos Residues in Confmed Rotational crops: Additionallnfonnation Requested by EPA: Addendum I: Lab Project Number: DE051601: 101958-1. Unpublished study prepared by Bayer, Corp. 7 p. 

### No Murphy, 1. (1996) DEF 6EC--Magnitude ofthe Residue in Cotton Processed Products: Additional Information Requested by EPA: Addendum 1: Tribufos: Lab ProjectNumber: DEI9CTOI: 106988·1. Unpublished study prepared by Bayer Corp. 7p. 

### No
B;;yer CropScl!mce, P.O. Box 12014. Research Triangle Park. North Carolina :zn09 Tel. 919 549-2000 7/16/1993
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45499501 Page 16of18 Bowers,1. (1996) Chronic Toxicity of(camon 14)-DEF to the Waterflea (Daphnia magna) Under Static Renewal Conditions: Lab Project Number; DE840701: 107327. Unpublished study prepared by Bayer Corp. 64 p. 

### No Fomenko, J. (1996) Independent Laboratory Validation for the Determination ofTribufos Residue in Animal Tissues and Milk: Lab ProjectNumber: 107511: DEI10201: AOI2.022. Unpublished study prepared by Maxim Technologies, Inc. 61 p. 

### No Krolski, M. (1997) DEF 6 EC--Magnitude ofthe Residue on Cotton: Lab Project Number: DE19CT03: 107903: 105026. Unpublished study prepared byBayer Corp. 270 p. 

### No Krolski, M.; Mattern, G.; Lemke, V. et at. (1998) Additional Comments on the Chapters ofReregistration Eligibility Decision Document for Tribufos (DEF): Lab Project Number: 108756. Unpublished study prepared by Bayer Corporation. 

## 96 p. 

### No Wills, M. (2000) ADermallIntravenous Crossover Siudy to Determine the Dermal Absorption of(carbon-14)·DEF 6 (S,S, S· Tributylphosphorotrithioate) in Male Rhesus Monkeys: Lab Project Number: 99C·B29·PR: 0834·90: 9143. Unpublished study prepared by Sierra Bioniedical, Inc. 180 P. 

### No Ripperger, R.; Kimball, S.; Fisher, J. et al. (2000) Tribufos (DEF) Washoff Study from Cotton Leaves: Lab ProjectNumber: DE231601: 108708. unpublished study prepared by Bayer Corporation. 57 p. 

### No Sheets,**1.~** Gilmore, R (2000) An Acute OralNeurotoxicity Screening Study with Technical Grade Tribufos (DEF) in WistarRats: Lab Project Number: 98-412-WF: 109802. Unpublished studyprepared by Bayer Corporation. 476 D, iOPPTS 870,6200} 

### No Sheets, 1.; Gilmore, R. (2001) A Subchronic Neurotoxicity Screening Study with Technical Grade Tribufos (DEF) in Wistar Rats: Lab ProjectNumber: 99-N72-BB: 110242: 9465. Unpublished study prepared by Bayer Corp. and Pathology Associates International. 538 p. 

### No Jensen, T.; Jones, R. (2001) The Homogeneity and Stability ofTribufos (DEF) Technical inRodent Ration Using Purina Mills Rodent Lab Chow 5001-4 Etts: Lab ProjectNumber; 99·H72·AL: 9464: 109070. Unpublished study prepared by Bayer Corp. 13 p. 

### No Fontaine, 1. (2001) Product Chemistry ofDEFTechnical: Lab Project Number: BR 2076: 110693: 109916. Unpublished study prepared by Bayer Corporation. 116 p. 

### No Fontaine, L, (2001) Product Chemistry ofDEF 6 Emulsifiable Defoliant: Lab Project Number: ANR·0460I: ANR-04701: 605041. Unpublished study preparedby Bayer Corporation. 47 p. 

### No Sheets, L. (2001) ADevelopmental Neurotoxicity Screening Study with Technical Grade Tribufos (DEF) in Wistar Rats: Lab ProjectNumber: 00- D72·AG: OO·D72·AS: 110523. Unpublished study prepared by Bayer Comoration. 12810. fOPPTS 870.63001 

### No Fontaine, 1. (2001) Product Chemistry ofDEF 6 Emulsifiable Defoliant: Lab Project Number: 110683: BR 2083. Unpublished study prepared by Bayer Corporation. 8p. {OPPTS 830.6317} 

### No Lake, S. (2001) ADevelopmental Neurotoxicity Screening with Technical Grade Tribufos (DEF) in Wistar Rats: Lab ProjectNumber: OO-D72-AG: 00· !**~72'AS. unpublb~hed**  study prepared by Bayer Corporation. 1281 p.

OPPTS 870.6300 

### No
BayerCropSclenco, P.O. Box: 12014, Ros"'iilrch Tri.mglo Park, North Carolina 27709 Tel. 919 549·2000 411211996

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149213 142425 Page 17 of 18 Fontaine, L. (2001) Product Chemistry ofDEF Technical Defoliant: Lab ProjectNumber: 110732: ANR-08501. Unpublished study prepared by Bayer Corporation. 155 p. {OPPTS 830.1550, 830.1600, 830.1620, 830.1670, 830.1700, 830.1750, 830.1800} 

### No Fontaine, L. (200I)Product Chemistry ofDEF Teclmical Defoliant: Lab ProjectNumber: 110682. Unpublished study prepared by BayerCorporation. 9 

### p. (OPPTS 830.6317) 

### No Wood, s. (2002) Terrestrial Field Dissipation ofTribufos on Mississippi Soil, 2000: Lab Project Number: DE022102: 110590. Unpublished study prepared by Stoneville R&D, Inc., A & L Great Lakes Laboratories, and Bayer Corporation. 84 p. 

### No Blankinship, A.; Kendall, T.; Krueger, H. (2002) Tribufos Technical: A FlowThrough Life-Cycle Toxicity Test with the Saltwater Mysid (Mysidopsis bahia): Lab ProjectNumber: 149A-133A: DE843101: 200363. Unpublished study prepared by Wildlife International, Ltd. 77 p. {OPPTS 850.1350} 

### No Kern, M.; 

### Lam, C. (2002) Early 

### Life Stage Toxicity ofTribufos to the Fathead Minnow (Pimephalespromelas): Lab ProjectNumber: DE841201: 200308. Unpublished study prepared by Bayer Corporation. 79 p. 

### No Bowers, L. (2002) Tier 2 Seedling Emergence and Vegetative Vigor NontargetPhytotoxicity Study Using DEF 6: Lab ProjectNlUllber: DE45160I: DE451602: 200245. Unpublished studyprepared by Bayer Corporation. 105 

### o. No Kern, M.; Lam, C. (2002) Toxicity ofTribufos Technical to Duckweed (Leoma gibba 03): Lab ProjectNumber: DE88370 I: 200301. Unpublished studyprepared by Bayer Corporation. 45p. 

### No Kern, M.; Lam, C. (2002) Acute Toxicity ofTribufos Technical to the Fathead Minnow (pimpepbales promelas) UnderFlow-Through Conditions: Lab ProjectNumber: DE831202: 200144. Unpublished study preparedby BayerCorporation. 34 p. 

### No Palmer, S.; Kendall, T.; Krueger, H. (2002) Tribufos Technical: An Early Life-Stage Toxicity Test with the Sheepshead Minnow (Cyprinodon variegatus): Lab ProjectNumber: 149A-134: DE842801: 200336. Unpublished study prepared by Wildlife International, Ltd. 82 p. {OPPTS 850.1400) 

### No Macb, I. (2002) Tribufos: Acute Dietary Toxicity Testwith the White-Footed Mouse (Peromyscus leucopus): Final Report: Lab ProjectNumber; 02005: DE73260 I: 110770. UnpUblished study prepared by Genesis Labomtories, Inc. 91 p. {OPPTS 850,2200} 

### No Fontaine, L. (2003) Product Chemistry ofDEFTechnical Defoliant Project Number: 02S009, G20043I. Unpublished study prepared byBayer Corp. 49 

### I p. 

### No

Matlock, D.; Lam, C. (2010) Early Life Stage Toxicity ofTribufos Technical to the Fathead Minnow (pimephales promelas) UnderFlow-Through Conditions. ProjectNumber: EBTRLOOI, M/360947/0Ill. Unpublished study preparedby BayerCropScience. 96 p. 

### No Thyss,en, 

### J.; Mohr, V.; Lorke. D. (1978) DEF: Subacute Inhalation Study on Rats: Report No. 7649. Unpublisbedstudy prepared by BayerAG. 63 p. 

### No Crawford, 

### C. (1971) TreatmentStudies for DEF Intoxication: Report No. 30093. Unpublished study prepared by Chemagro Corp. 7 p. 

### No

8aYllr CropSclenoe, P.O. Box 12014, Research Trillngle Park, North Carolina 27709 Tel. 919 549-2000 11/21200I

lI12f200I

2/412003

2/4/2003

2/412003

2/4/2003**7j4~003**



# -
1 7!1t12!103 

# i ! 

# I2"V1003

2/4/200)

6/2412003

lI2012010144939

49400

45464601

48054901

45194402 Page 18 of 18
Root, M.; DiGiacomo, R; Meskauskas, J.; et al. (1967) EffectofDEF in the Diet on the Reproduction and Lactation ofMice. Unpublished Mobay report 21543 prepared by Univ. ofChicago, Toxicity Laboratory. 7 p. 

### No Chemagro Corporation (1968) Residue ofDEF : Report No. 21889. (Compilation; unpublished study includingreportno. 21892, received Mar 22, 1976 under 3125·71; submitted byMobay Chemical Corp., Kansas City, Mo.; CDL:224112-K) 

### No SheetS, L.; Gilmore, R. (1999) Verification ofPersonnel Training to Perform a Functional Observational Battery with Rats: Lab Project Number: 97-962-LG. Unpublished study prepared by Bayer Corporation. 94p. 

### No Smead, C.; Macke, M. (2010) Material Accountability ofTribufos (DEF) Technical: Analytical Profile ofFive Batches. Project Number: Ml366585101/l/0CR, 901571/0CR. Unpublished study prepared byBayer CropScience. 53 p. 

### No Wahle, B. (2000) An Experimental Functional Observational Battery Validation Study with Carbaryl in WistarRats: Lab ProjectNumber: 99-N82- !**~?** 109406.**un~~~liShed** studyprepared by BayerCorporation. 102 p.

OPPTS 870.6200 

### No**8~yer** CropScience, P.O. BOl( 12014, Research Triengll! Park, North Carolina 27709 T!ili. 919 549·2000,)


# Attachment 4

### VIA CERTIFIED MAIL August 20, 2010 Bayer Cropscience LP 2T.W. 

### Alexander Drive Research Triangle Park, NC 27709

# :illi~1:~>**WI~}\ W~gMT**  ReClllatory A$so<:lates, Inc. PO 60x 640 7460 lilnclster Plktl, Suit!! S Htldessln, DE 197tl7



### Re! Offer to Pay Compensation for Data Used to Support Pesticide ProductRegistration 

### Dear Sir orMadam: RedEagle !itternational LLC 

### e'RedEagle") is submitting a**l"(~gistratioll** 

### application 

### to the U.S. 

### Environmental Protection Agency ("EPA") for a technical grade product contaiuing Tl'ibufos as the active ingredient for all uses cUll"entiy approved 

### by EPA, Your company is listed on 

### the March 31. 2010 EPA "Data 

### Submitters List" for Tribufos active ingredient. In applying for this registration, RedEagle is using the cite-all under selective method of data support. In accordance 

### with the requirements of the cite-all method under the Federal Insecticide, Fungicide and Rodenticide Act ("FIFRA") and 

### 40 C.F.R. Palt 152.86, RedEagIe hereby offers to pay reasonable compensation after the approval of this application, to the extent reqnired by FIFRASection 3(cX1)(F) and/or 

### FIFRA Sectioll 3(c)(2)(B), for specific and valid data for which your company is identified by the EPA as 

### an original data submitter and on 

### which 

### this applicatioll relies. RedEagle offers to begin negotiations to detennine the amount aud tenus ofthe compensatioll, ifany, to 

### be paid for any such data. For each study for which EPA considers your compaJ.1y to be 

### an original data 

### submitter and 

### for which you seek compensation, please identify the data items 

### and any terms of compensation that you PJ.·opose. If we do not receive yO'lU' response within 

### 90 days, 

## we will presume that YOUI' 

### company seeks no compensation. Sincerely,

James 

### M. Wagner Agentfol' RedEaglc Iutel'national LLCAugust 6, 2010 Document Processing Desk (REGFEE) ATTN: Jim Tompkins, PM Team 25 Registration Division U.S. Environmental Protection Agency Office ofPesticide Programs (7504P) Room S-4900, One Potomac Yard 2777 South Crystal Drive Arlington, Virginia 22202-450I DearMr. Tompkins, 

### 481798·00

Wagner Regulatory Associates, Inc. P.O. Box 640 7460 Lancaster Pike, SUite 9 Hockess'ln, Delaware 19707

Subject: Application to register a new technical grade product containing a currently registered active ingredient

- "Tribufos Technical" Wagner Regulatory Associates, Inc., as agent for RedEagle International LLC, is requesting registration ofthe above referenced product. This product is substantially similar to the tribufos product (DEF Technical) registered by Bayer CropScience, LP under EPA Registration Number 264-720. In support ofthis request, the following documents and studies are attached:

• Letter from RedEagle International LLC appointing Wagner Regulatory Associates, Inc. as its agent • Application for Pesticide Registration (8570-1) • Confidential Statement ofFonnula (8570-4), 2 copies • Certification with Respect to Citation ofData (8570-34) • Data Matrix (8570-35) • Data Transmittal Document • Product Identity and Composition data (3 copies) as outlined in the transmittal document • Preliminary Analysis data (3 copies) as outlined in the transmittal document • Physical and Chemical Properties data (3 copies) as outlined in the transmittal document • Draft labeling, 3 copies and CD • A copy ofthe EPA approved label for EPA Reg. No. 264-720 and • A copy ofthe receipt continning payment ofthe required registration fees. RedEagle International LLC has submitted payment to U.S.EPA in accordance with PRJA II Fee TableFY09IFYIO, for action categoryR3IO

- $4,578. Ifyou have any questions about this submission please contactthe undersigned. Respectfully submitted,

Catherine M. Byrd Agent for RedEagle International LLC Enclosures

### 1. DATA TRANSMITTAL DOCUMENT Name and Address ofSubmitte;r 

### RedEagJe International LLC c/o Wagner Regulatory Associates PO Box 640 Hockessin, DE 19707 

### 2. RegulatorY Action In Support OfWhich This Package Is Submitted



### 3.

4. Application for Registration Tribufos Technical 

### Transmittal Date August 6,2010 Ust ofSubmitted Studies**-'--"~-'-'------"~----'-"C=-;CC- --'--,,,,,,=~=cc:** 

Vol. I: Wagner Regulatory Associates, Inc. (2010) Tribufos Tec1mical Product 

### 48179801 Chemistry Data Waivers. RedEagJe Intemational LLC, Lakeland, Florida. 4 pages. 

## -----·-yoCT"'"wagnerRegulat;Ty 

### Associates,-fuc. (2010) Tribufos**Teclmical~Product** fdentity and Composition, Description ofBeginningMaterials, Manufacturing Process, 

### 48179802 and Discussion ofFonnation ofTmpurities. RedEagle Intemational LLC, Lakeland, Florida. Non-confidential portion 6 pages, Confidential portion 57pages. '--'-'-"---'-"'01. 3:' Sun, Gang (2010) PreJin"rirullY**A~laly~is** ofTribufos Technical Grade Active 

### 48179803 Ingredient. Southwest Research Institute, SanAntonio, Texas. RepOit Number 01.14990.02.001. Non-confidential portion 19 pages, Confidential portion 16 pages.

.**~--------.-"**..- Vol.**4~'-'Sun'~** Gang**(20l0j~** Trib-ufosTechnical Grade Active Ingredient Physical and 

### 48179804 Chemical Characteristics. SouthwestResearch Institute, San Antonio, Texas. Report Number 01.14990.02.002. 16 pages.
Company Official:

Company Name: Company Contact: Catherine M. Byrd Name Wagner Regulatory Associates, Inc. Agent for RedEagle International LLC
Catherine M. Byrd Name Signature



### (302) 234-2.'80 PhoneForm Approved OM 05.20 

## . " o 7: 2 

# , , BN 700060 070-05 070-01072070012220700164

### /'~ UN(TED STATES ENVIRONMENTAL PROTECT(ON AGENCY

## \~ 1200 Pennsylvania Avenue, N.W. WASH(NGTON, D.C. 20460 Pape.wurk ReduClion Act Notice: Thc publicrl'poning bunkn forthis cotle\:tion ofinfmmntinll is estimated to nvcrngc 1.25110111'5 per response for registrntion :md 0.25 hours per re!ponse for reregistrm..ion Md spcdal review nctiyil ies, including time for readillg the inSlfUctions nlld completing tile lIc.:<:ssnryfOIms. Scud commo:OIS rcgardingburdenestimate orany OIllCfIISp'.:d oflliis collection ofinlbmlulion, illctuding**sn£!~cslions** ror**r~ducing** Ihc burden 10: Di=lor. COllection Strategics Divisirn{2SUl), u.S. Environmental Prot!."l;lion Agency. t200 Pcnnsylvani.1 Avenue, NW.,Wasloington, DC20460. Do not.end the complelo:<! fonn to this address. Certification with Respect to Cilation ofData AppIiCilnl'sJRegi51rant'S Name, Address, and Telephone Number EPA Registration NumberfFile Symbol RedEagle Intemational LlC, P.O. Box 640, Hockessin, DE 19707 85678- Active InQredient(S) and/or reoresentalivalem comooundfs) Date Tribufes Augusl 6, 2010 General Use Paltem(s) (fist all lhose claimed for this producl using 40 CFR Part 158) Product Name Terraslrial Non-Food; Tribufos Technical NOTE: Ifyour prOlluct is a 100%, repackaging ofanother purchased EPA-registered product labeled for alt Ihe 5<lme uses on your label, you do nolneed 10 submn this form. You ITlUSI submH the Foonulalor's Exemption Statement (EPA Form 8570-27), 

# 0 I am responding 10 a Data-CaU-ln Notice, and have inclUded wtth Ihls lorm a list 01 companies senl offers of compensallon (the Data Matrix folm shoutd be used for this purpose),
SECnON I: METHOD OF DATA SUPPORT (Check one melhod only) 

# 0 t am using the cile-lltt melhod of 5Upport, and have included wilh Ihis form 

# 0 I am USing the selective melhod ofsupport (or cite-all option a fist ofcompanies sentoffel'll ofcompensation (Ihe Data Matrix form underthe selective melhod), and have included with thts \orm a shOUld be U$"ed forthis purpose}. completed list of data requilemenis (lhe Dala Malrix form musl be used). SECnON II: GENERAL OFFER TO PAY IRequill!d ifuslng lhe cile.all method orwhen using the die-ali**op~on** under Ihe selective melhod 10 satisfy one or more dala requirements! 

# 0 t hereby offerand agree to pay compensation, 10 other persons, wilh regard to the approval ollhis applicalion. to Ihe extent required by FtFRA.
SEcnON ttl: CERnFICAnON I cerl!fy that !his appUcarlon for regtslration, this form for reregislration, orlhls Dala-Call-In response is supported by all data submitted or cited in the application for registration, \he form for reregistration, orthe Dala-Call-In respOnse. In addition, if\he cite-alt opllon or dte-all option under the selective method is inc&caled m**Sec~on** I, this appllcation is supported by all dala in the Agl!ncy's files Ihal (1) concem the properties or effects of Ihis product or an identical or subslantiallysimilarprooud, or one or more ofthe ingredients in Ihis producl; and (2) is a Iype ofdata Ihal would be required 10 be submitted under ttle data requiremenl:! in effect onlhe date of approval 01 this applicoUon'lflhe appflcotlon soughllhe initial registration ofa product ofldenlical or similar composilion and uses, I certify that for each exclusive use study cited in support oflhis registration or reregistration, thai I am Ihe**oliginaldal~** submilter or \hat I have oblained !he written permission ofthe Original dala submillerlo cite that study. tcertify llratfor each sludy cited In support of Ihis registration or reregistration that is nol an exciusiye use study, eilher: (a) I am Ihe origlrml data submitter; {b) I have obtained Ihe permis5ion ofthe original data submilter 10 use Ihe study in support ofIhis application: (c) all periods ofeligibilily for compensaUon have expired for the l>1udy; (d) !he study is in the pubWc literalure; or (e) t have notified in vrrillng Ihe company thai submitted lhe sludy and have offl!red (Q \0 pay compern;alion to Ihe exlenl required by sections 3(c)(1)(F) andfor 3(c)(2)(B) of FIFRA; and (ii) 10 commence negotiations to delermine the llmouol and tennl> ofcompensation, Ifany, to be paid forlhe use of\he study. Icertify \hal in all instances where an offer of**compensa~on** is required, copies ofaU offers 10 pay compensation and evidence of !heir deflvery in accordance with sections 3jc)(1){F) andlor 3(c)(2)IB) ofFtFRA are available and win be sUbmilted 10 Ihe Agency upon request. Should Ifail 10 produce such evidl!nce \0Ihe Agency upon request, I urn:!ersland \hat Ihe Agency may iniUale llctionlo deny, calrcel or suspend the registration 01 my producl in conlormity with FtFRA. t certify thatthe i1itDwmentli t havo made onthis form and aU attachmentli to It aro truo, accurato, and comploto, I acknowtedgo that any knowingly fatso or mfsloatllng iIitillomonl milY be punilihable by fine or Imprisonment or both under applicable law. Signature

# {JJif'i1J{fA~

# ?J1.**gjl~** Date Typed or Prote<! Name and Title OaJ06f20to CatheriIle M. Byrd, Agenl

. EPA Form 8570-34 (12 2003) Electronic and Paper vernlons**ava~abte.** Submit only Paper version

.Please read instructions on reverse before**com·-'"~If!gform.** Form**Approv~-<,** OMS No. 2070·0060, Aooroval expires 05-3t·98 I 

## X agistration OPP Identifier Number 

# oEPA United States 

### Environmental Protection Agency Amendment Washington, DC 20460 

### Other Application for Pesticide
- Section I 1. Company/Product Number 2. EPA Product Manager 3. Proposed Classification 85678- 

# Rr-J Jim Tompkins 4. CompanylProduct (Name) 

### PM" 

## IEl None Restricted Red Eagle International LLC/ Tributos Technical 25 5. Name and Address otApplicant (Include Zip Code) 6. Expedited Review. In accordance with FIFRA Section 3(c)(3) RedEagle International LLC (b)(I), my product is similar or identical in composition and labeling to: c/o Wagner Regulatory Associates, Inc. EPA Reg. No. 264-720 P.O. Box 640 Hockessin, DE 19707 Product Name: OEF Technical 

# o Check ifthis is a new address 

### Section 

# - II 

# 0 Amendment
- Explain below. 

# 0 Final printed labets in response to Agency letter dated 

# 0 Resubmission in response to Agency letterdated 

### Ijg "Me Too" Application. 

# 0 Notification
- Explain below. 

# 0 Other
- Explain below. Explanation: Use additional page(s) if necessary. (For Section I and Section II.) 

### Section 

# - III 1. Material This Product Will Be**Packa~ed** In: Child-Resistant Packaging**U~ckaging W~Soluble**  Packaging 2. Type ot Container 

# tR3 Yes' Yes Yes Metal



## X No 

# ex No 

# X No 

## X Plastic tt"Yes" No. per It "Yes" No. per Glass 

### * 

### Certificatron must Unit Packaging wgt. container Package wgt container Paper 

### be submitted 

# I Other (Specify) HOPE lined bags 3. Location of Net Contents Intormation 4. Size(s) Retail Container 5. Location of Label Directions



# rn Label 

# o Container 275 

# fK3 On Label X On Labeling accompanying product 6. Manner in Which Label is Affixed to Product 

# §J Uthograph 

# CJ Other



### - X Paper glued Stenciled 

### Section 

### IV 

## ,


# - " 

### , 

# . 1. Contact Point Com lete items direct! be/ow foridentification ofindividual to be contacted, ifnecessa , to processJliJis"appljcation. Name 

# ITitle 

# ITeleph9'J'7**./'J£'~ (lnchj'deA~a**  Code) Catherine M. Byrd Agent for RedEaQle International LLC I (302) 234 ,,761> , Certification 6. Date Applictiion I certify that the statements I have made on this fonn and all attachments theleto are true, accUiate and complete. } ; )**R~ceived** )**~** > I acknowledge that any knowingly false 01 misleading statement may be punishable by fine or imprisonment or 

# . • 

# .. both under applicable law. " ) >J (SMmp'ed) 2. Signature 3. Title 

# . . , , 

### • > , , ) Agent for Red Eagle International LLC 

### , ,

# ~Jrx.&jrzL - , '-' >**~** , >0), , 

### •

,

## , ," 4. Typed Name 8/6/2010 Catherine M. Byrd



## ..
- - This IS a reproduction of EPA Form 8570 1 (Rev. 8 94) PrevIous editions are obsolete./'**~** Form Approved OMB No. 2070-0060 f .ft. 

## l**\~'** UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

,...,..';/ 401 M Street, S.W. WASHINGTON, D.C. 20460 PaperworkReduction Act Notice: The publicreporting burden for this col!ection ofinfonnation is estimated to average 0.25 hours per response fOf registration activities and 0.25 hours per response for reregistration and special review activities, including time for reading the instruction and completing the necessary forms. Send comments regarding the burden estimate Of any other aspect ofthis collection ofinformation, including suggestions for reducing the burden to: Director, OPPE Information Management Division (2137), U.S. Environmental Protection Agency, 401 M Street, S.W., Washington DC 20460. Do not send the form to this address. DATA MATRIX Date: 8/6/20I0 EPA Reg

### No.1 File Symbol: 85678- 

# IPage 1 

### 00 Applicant'sJRegistrant's Name and Address: RedEagle International LLC Product: c/o Wagner Regulatory Associates Inc. P.O. Box 640 Tribufos Technical Hockessin, DE 19707 Ingredient: Tribufos
Guideline Reference Number Guideline Study Name MRID Number Submitter Status Note PRODUCT SPECIFIC 830.1550,830.1600,830.1650, Product identity, composition/Description of RedEagle International LLC Own 830.1670, materials Used to Produce the ProductJDescription ofFormulation ProcesslDiscussion ofFormation ofh l1purities 830.1700 Preliminary Analysis RedEagle International LLC Own 830.1750 Certification ofLimits RedEagle International LLC Own I 830.1800 Enforcement Analytical Method RedEagle International LLC Own 830.6302 Color RedEagle International LLC Own 830.6303 Odor RedEagle International LLC Own 830.6304 Physical State RedEagle International LLC Own 830.6313 Stability to Normal & Elevated Temperatures RedEagle International LLC Own 830.6314 OxidationIReduction RedEagle International LLC Own 830.6315 Flammability RedEagle International LLC Own 830.6316 Explodability RedEaJde International LLC Own 830.6317 Accelerated Storage Stability RedEagle International LLC Own 830.6319 Miscibility RedEagle International LLC Own 830.6320 Corrosion Characteristics**RedE~gle** International LLC Own 830.6321 Dielectric Breakdown Voltage RedEagle International LLC Own 830.7000 

### loH RedEagle International LLC Own 830.7050 UVNisible Light Absorption**RedE~le** International LLC Own 830.7100 Viscosity RedEagie International LLC Own 830.7200 Melting Point RedEagle International LLC Own

# S~u"**~f1z&fd-** Name and Title Date Catherine M. Byrd, 8/612010 Agent for RedEagle International LLC 

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

## _-_

.._---_ ..

### _--_
....

## _-_

....

# __ ._.- -_. -_ .. -_.. _. - - - - EPA Form 8570-35 (9-97) Electronic and Paper versions available. Submit only Paper versIOn. Al!:encv Internal ITSf' ("'rmv

# ." Form Approved OMB No. 2070-0060 

# 'ez)**~.-,,'** UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 401 M Street, S.W. WASHINGTON, D.C. 20460 PaperworkReduction Act Notice: The public reporting burden for this collection ofinfonnation is estimated to average 0.25 hours per response for**reg~stration** activ!ties and 0.25. hours per response for reregistration and special review activities, including time for reading the instruction and completing the necessary forms.**S~iJd c6!llhl~nt5J<jg~rd~n~the~**  burden estimate or any otheraspect ofthis colIection ofinformation, including suggestions for reducing the burden to: Director, OPPE Infonnation Nfan:igementthvisio:9 (lI3?), : " U.S. Environmental Protection A!!encv, 401 M Street, S.W.,

### Washi~lrton DC 20460. Do not send the form to this address. -'

-

### ~ -

### ~ DATA MATRIX**~ ~**  " 

### - Date: 8/6/20I0 EPA Reg No.1 File Symbol: 85678· 

## .**_~_j_Ea~e~~?f3** o 0 • "

. Applicant'slRegistrant's Name and Address: RedEagle International LLC Product:**~** 

### --**~** 

### - . c/o Wagner Regulatory Associates Inc. P.O. Box 640 Tribufos Technical Hockessin, DE 19707 Ingredient Tribufos 

## 1 Guideline Reference Number Guideline Study Name MRIDNumber Submitter Status Note 830.7220 BoOing Point RedEagle International LLC Own 830.7300 Relative Density RedEagle International LLC Own 830.7370 Dissocation Constants in Water RedEagle International LLC Own 830.7520 Particle Size, Fiber Length, and Diameter RedEagle International LLC Own Distribution 830.7550 OctanollWater Partition Coefficient RedEagle International LLC Own 830.7840 Solubility in Organic Solvents RedEagle International LLC Own 830.7840 Water Solubility RedEagle International LLC Own 830.7950**V~r** Pressure**RedE~gle** International LLC Own ACUTE TOXICITY & Cite All Agricultural Handlers Exposure Pay GENERIC DATA Task Force Macon,MO Agricultural Reentry Task Force WashilJ:gton, DC BASF Sparks LLC Research Triangle Park, NC Bayer Cropscience LP Research Triangle Park, NC Bayer Corp Kansas City, MO FIFRA Endangered Species Task Force, LLC Washington, DC



### Si.naMe

# ~f'l

# &fdName and Title Date Catherine M. Byrd, 8/6/2010 Agent for RedEagle International LLC**--~** .--. EPA Fonn 8570-35 (9 H 97) Electronic and Paper versions available. Submit only Paper version. A!!encv Internal**n~e** Conv.1" "'_ Form Approved OMB No. 2070-0060 

# t""\**~,** UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

",-,';/ 401 M Street, S.W. WASHINGTON,D.C. 20460 Paperwork Reduction Act Notice: The public reporting burden for this collection ofinformation is estimated to average 0.25 hours per response for registration activjties an4,0.25. hours perresponse for reregistration and special review activities, including time for rcading the instruction and completing the necessary forms. S2:id**co:nment5:r~g~'rd~ng,**the: 0 burden estimate or any other aspect ofthis collection ofinformation, including suggestions for reducing theburden to: Director, OPPE Information Man5:gcment Divisi:o!1 (213:7), =**~** U.S. Environmental Protection Agency, 401 M Street, S.W., Washington DC 20460. Do not send the form to this address.**~.** - . -**~** DATA MATRIX

- 

### --**~ ~**  

## - " Date: 8/612010 EPA Reg No.! File Symbol: 85678- 0

## ~_I"ra~e"~?f3 o**~** 0 0**~** Applicant'slRegistrant's Name and Address: RedEagle International LLC Product: . " -'"**~** 0 

### clo Wagner Regulatory Associates Inc. P.O. Box 640 Tribufos Technical Hockessin, DE 19707 Ingredient: Tribufos 

# -I

- -- - -_ .. ---_.- -_ .. ---- ..... _---- .. 

### __ ... ---- ...---- Guideline Reference Number Guideline Study Name MRIDNumber Submitter Status Note Outdoor Residential Exposure Task Force, LLC Washington, DC Spray Drift Task Force Washington, DC Footnotes: I) Certification ofLimits is provided in the Confidential Statement ofFormula EPA form 8574-4



# .**~fl-&jd--** Name and Title Date Catherine M. Byrd, 8/612010 Agent for RedEagie International LLC Signature EPA Form 8570-35 (9-97) Electronic and Paper versions available. Submit only Paper version. Al!encv Internal**n~(>** C'nnvAugust 6, 2010 Document Processing Desk (REGFEE) ATTN: Jim Tompkins, PM Team 25 Registration Division U.S. Environmental Protection Agency Office ofPesticide Programs (7504P) Room S.4900, One Potomac Yard 2777 South Crystal Drive Arlington, Virginia 22202·4501 Dear

### Mr. Tompkins, Wagner Regulatory Associates, Inc. P.O. Box 640 7460 lancaster Pike, SUite 9 Hockessin, Delaware 19707

Subject: Application to register a new technical grade product containing a currently registered active ingredient· "Tribufos Technical" WagnerRegulatory Associates, Inc., as agent for RedEagle International LLC, is requesting registration ofthe above referenced product. This product is substantially similar to 

### the tribufos product (DEF Technical) registered by Bayer CropScience, LP under EPA Registration Number 264·720. In support ofthis request, the foilowing documents and studies are attached:
• Letter from RedEagle International LLC appointing Wagner Regulatory Associates, Inc. as its agent • Application for Pesticide Registration (8570-1) • Confidential Statement ofFormula (8570·4), 2 copies • Certification with Respect to Citation ofData (8570·34) • Data Matrix (8570·35) • Data Transmittal Document • Product Identity and Composition data (3 copies) as outlined in the transmittal document • Preliminary Analysis data (3 copies) as outlined in the transmittal document • Physical and Chemical Properties data (3 copies) as outlined 

### in the transmittal document • Draft labeling, 3 copies and CD • A copy ofthe EPA approved label for EPA Reg. No. 264·720 and • A copy ofthe receipt confirming payment ofthe required registration fees. RedEagle International LLC has submitted payment to U.S.EPA in accordance with PRIA II Fee TableFY09/FYlO, for action category R310 • $4,578. Ifyou have any questions about this submission please contact the undersigned. Respectfully submitted,

Catherine M. B)Td Agent for RedEagle International LLC Enclosures

### 1.



### 2.



### 3.

4. DATA TRANSMITTAL DOCUMENT 

### Name and Address ofSubmitter RedEagle International LLC 

### cIa Wagner Regulatory Associates PO Box 640 Hockessin, DE 19707 

### Regulatory Action In Support OfWhich This Package Is Submitted Application for Registration Tribufes Technical 

### Transmittal Date August 6,2010 

### list of Submitted Studies

-·,,-'"-----V=ol'.2;"""**Wagne;~R~gui"atoiY'-As~~ciates, Inc:-(2'OlOY'1~ributos-T~cl~lical-Pioduct---"­**  rdentity and Composition, Description ofBeginningMaterials, Manufacturing Process, and Discussion ofFonnation ofImpurities. RedEagle Intematlonal LLC, Lakeland, Florida. Non-confidential portion 6 pages, Confidential portion 57pages. Vol. 3: Sun, Gang (2010) Preliminary Analysis ofTribufos Tecllllical Grade Active Ingredient. Southwest Research Institnte, SanAntonio, Texas. Repolt Number 01.14990.02.00L Non"confidential portion 19 pages, Confidential pOltion 16 pages. Vol. 4: Sun, Gang (2010). Tribl1tos Teclmical Grade Active Ingredient Physical aud Chemical Characteristics. Southwest Research Institute, San Antonio, Texas. Report Number 01.14990.02.002. 16 pages.


### Company Official:

Company Name: Catherine M. Byrd Name Wagner Regulatory Associates, Inc. Agent for RedEagfe International LLC Signature

, 

### , " " 

### , 

# . .. • 

# .

" • 

## ,. 

# . · , 

# .. , Catherine M. Byrd 

### (302l234-t',!l.IL'_ ,:, Company Contact:



# .. 

# . Phone Name 

# · . , 

# · , > > , > 

# · 

# . ) , > , , >

, , , > ", 

### ,

## R310 Must submit Group A and Bproduct chemistry data for each proposed product. End Use IEP) or Manufacturing Use IMP) product or Technical Grade of the Active Ingredient ITGAI)

/ 

### EP Dafa MP Data 

## / Guideline 

### Group A: Product Chemisfry Data Submitted Submitted TGAI No. Studyrltle Yes No Yes No Yes No 

### 830.1550 Product Identity & 

### Composition 

# V Description of materials used to 

# V 830.1600 _producetheoroduct 

### 830.1650 Description offormulation process 

# v 830.1670 Discussion on the formation of impurities 

# V 830.1700 Preliminary analysis 

# V 830.1750 Certified limits 

### 1158.345) 

# v 830.1800 Enforcement analytical method 

# \/" EP Data MP Dafa Guideline Group B: 

### Product Chemisfry Data Study

## ~~~~L~~~~LkTI<G~A~1**r:-:-~** Title



### '1

Iii

I I



### 1

# R310

New products must either: I) supply the product specific acute toxicITY 6 pack data (listed below), 

### or 

### 2) provide a bridging rationale document. The bridging document directs opp 

### to use a currently registered set of 6 acute toxicity data and label; instead of submitting product specific data.
Data Guideline Acute toxicity (6 pack) submitted 

### CHed No. Study Title Yes No Yes No 870.1100 Acute Oral (LD50) 

# ,/ 870.1200 Acute Dermal (LD5OJ 

# ,/ 870.1300 Acute Inhalation (LC50) 

# ,/ 870.2400 Acute Eye Irritation 

# ,/ 870.2500 Acute Dermal Irritation 

## ,/ 870.2600 Dermal Sensitization 

# /

Efficacy
- which guideline is used depends on the proposed label use Data Guideline submitted Cited No, Study Title Yes No Yes No Comments 

### 810.3100 Soil Treatments for Imported Fire Ants Livestock, Poultry, Fur and Wool-Bearing 810.3200 Animal Treatments Treatments to Control Pests of Humans and 810.3300 Pets Mosquito, Black Fly, and Biting Midge 810.3400 ' (Sand Fly) Treatments 810,3500 Premises Treatments 810.3600 Structural Treatments 

### Methods for Efficacy Testing ofTermite 810.3800 Baits



### 2Print Letter Enter More InformmJon TrackingAugust 6, 2010 Document Processing Desk (REGFEE) ATTN: Jim Tompkins, PM Team 25 Registration Division U.S. Environmental Protection Agency Office ofPesticide Programs (7504P) Room S-4900, One Potomac Yard 2777 South Crystal Drive Arlington, Virginia 22202-4501 Dear Mr. Tompkins, 481798.()O

Wagner Regulatory Associates, Inc. P.O. Box 640 7460 Lancaster Pike, Suite 9 Hockessin, Delaware 19707

Subject: Application to register a new technical grade product containing a currently registered active ingredient

- "Tribufos Technical" WagnerRegulatory Associates, Inc., as agent for RedEagle International LLC, is requesting registration ofthe above referenced product. This product is substantially similar to the tribufos product (DEF Technical) registered by Bayer CropScience, LP under EPA Registration Number 264-720. In support ofthis request, the following documents and studies are attached:
• Letter from RedEagle International LLC appointing Wagner Regulatory Associates, Inc. as its agent • Application for Pesticide Registration (8570- 1) • Confidential Statement ofFonnula (8570-4), 2 copies • Certification with Respect to Citation ofData (8570-34) • Data Matrix (8570-35) • Data Transmittal Document • Product Identity and Composition data (3 copies) as outlined in the transmittal document • Preliminary Analysis data (3 copies) as outlined in the transmittal document • Physical and Chemical Properties data (3 copies) as outlined in the transmittal document • Draft labeling, 3 copies and CD • A copy ofthe EPA approved label for EPA Reg. No. 264-720 and • A copy ofthe receipt confinning payment ofthe required registration fees. RedEagle International LLC has submitted payment to U.S.EPA in accordance with PRIA II Fee TableFY091FY10, for action category R310

- $4,578. Ifyou have any questions about this submission please contact the undersigned. Respectfully submitted,

Catherine M. Byrd Agent for RedEagle International LLC Enclosures

### 1. DATA TRANSMITTAL DOCUMENT Name and Address of Submitter RedEagle International LLC c/o Wagner Regulatory Associates PO Box 640 Hockessin, DE 19707 

### 2. Regulatory Action In Support OfWhich This Package Is Submitted



### 3.



### 4. Application for Registration Tribufos Technical Transmittal Date August 6,2010 List of Submitted Studies

----,--,,---- Vol. ( Wa:,crner**ReguJ;t~ry**

## A;ocIaies, Inc. (2010) Tribufos 

### Tec1micaf

-**Prodl~-**



### 48179801 Chemistry Data Waivers. RedEagle International LLC, Lakeland, Florida. 4 pages. 

## -----·----VoC2:**':Y~el'** Regulatory Associates, 

### Inc. (2010) Tribufos 

### Technical-Product--- Identity and Composition, Description ofBeginning Materials, Manufacturing Process, 

### 48179802 and Discussion ofFormation ofImpurities. RedEagle Intemational LLC, Lakeland, Florida.**Non~confidential** portiOll 6 pages, Confidential portion 57pages. 

### -------"----vQ1. 3: 

## sUn, Gang (2-010) Preliminary Analysis ofTribufos TechnicalGrade Active

-- 

### 48179803 Ingredient. Southwest Researc1l Institute, San Antonio, Texas. Report Number 01.14990.02.00 I. Non-confidential portion 19 pages, COllfidential portion 16 pages. ---,-'"---- V**Ql'4-:'S~~,** Gallg 

### (2010). Trib"i.Jfos Technical o"rade Active lIlgreclient Physical

## aJld--'-- 48178804 Chemical Characteristics. Southwest Research Institute, San Antonio, Texas. Report Number 01.14990.02.002. 16 pages.
Company Official:

Company Name: Company Contact: Catherine M. Byrd Name Wagner RegulatoryAssociates, Inc. Agent for RedEagle International LLC
Catherine M. Byrd Name Signature



### (302) 234-2-'80 PhoneUNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D.C. 20460


### August 11, 2010
REDEAGLE INTERNATIONALLLC 7460 LANCASTERPIKE, SUITE 9, PO Box 640 HOCKESSIN,DE 19707-0640 Report ofAnalysis for Compliance -with PRNotice 86-5 OFFICE OF PREVENTION, PESTICIDES AND TOXIC SUBSTANCES



### Thank you for your submittal of09-AUG-lO. Our staffhas completed a preliminary analysis ofthe material. The results are provided as follows: Your submittal was found to be in full compliance with the standards for submission of data contained inPRNotice 86-5. A copy ofyour bibliography is enclosed, annotated 

### with Master Record ID1s (MRIDs) assigned to each document submitted. Please use these numbers in all future references to these documents. Thank you for your cooperation. Ifyou have any questions concerning this data submission, please raise them with the cognizant Product Manager, to whom the data have been released.

# 21-Day Screen Completed by Contractor 

# 21-Day Expires on _---,:;9--..:3::-0---'- /-.:;0,,---


# Jacket # <i?sG 

# 7t - 

# RAJ 

# MRID# LfE I 

# 792' 

# Content**scr~ecommended** 

# to as Fail 86-5 Review: assed Failed/NA 

# Transfer This Jacket to:



# PM 2::;-

# / PRIA 2

- 21 Day Content Screen Review Worksheet (EP AlOPP Use Only) 

### 3/23/09 21 Day Screen StartDate: 

# .&
- 9

- 10 /' Experts In-Processing Signature: 

# t1?e .!Ia/2/2N,/6Tt:W Date 

# S-**~/()** 

### -/0 Fee Paid: Yes

# y Division management contacted on issues No Yes Date
EPA Reg. Number: 

# lr**~**

## (p 

# 7 

# Ii
- 

# r< tJ EPA Receipt Date:



## 1

2 Items for Review Application Form (EPA Form 8570-1)(link to form) signed & 

### complete including packagetype Confidential Statement ofFormula all boxes completed, form signed, and dated a) All inerts (link to 

### http://www.epa.gov/opprdOOl/inerts/), including fragrances, approved for the proposed uses (see Footnote no



### 3 Certificationwith to Citation ofData 8570-34) (Link to



### 4 form) completed and signed (N/A 

### if 100% repack) Certificate and data matrix consistent Ifapplicant is relying on data that are compensable, is the offer to pay statement included. (see Footnote B) yes

(EPA Form 8570-27) (Link to form) and signed (N/A ifsource is unregistered or applicant owns the no Yes No 

### N/A*

Data Matrix (EPAForm 8570-35) (Link to form) both internal and external copies (PR 98-5) (Link to PR 98-5) completed and signed (N/A 

### iflOO% 

# X

5 a) Selective Method b) Cite-All (Fee category experts use) c) Applicant owns all data (Fee category experts use) 5 Copies ofLabel (linkto http://www.epa.gov/oppfeadl/labelingllrmO 6 (Electronic labels on CD are encouraged and guidance is available)( link to http://www.epa.gov/pesticides/regulating/regfsterfng/submfssions/index.htm#labels



### I

### 7 Is 

### the data p_ackage consistent with PRNotice 86-5 (link to PRN 86-5) 

# >< Notice ofFiling (linkto 

### 8**htt~:i** 

### /www.eQ3.gov/l!esticides/regulatingitolerance l2etitions.htm) included 

# X with petitions (link to http://www**.<jla.JlOv~sticides/re2ulating/tolerances.htm)** 

### 9 If

### applicable for conventional applications, reduced riskrationale (link to 

# X http://www.epa.gov/opprdOOllworkplan/reducedrisk.html) Required Data (linkto httl!://www.eQa.gOY 

### iQestici

### des/regulating/

### data 

### reguirements.htm) and/or data waivers. See Footnote C.

a) List study (or studies) not included 

### with application



## 10

2

### Comments:

## ~**)~**

# It?

*N/A
- Not Applicable

Footnotes 

### A During the 21 day initial contentreview, all eSFs will bereviewed to determine whether all inerts listed, including fragrances, are approved for the proposed uses. Ifan lU1approved inert is identified, the applicant must either I) resolve the inert issue by, for example, removing the inert, substituting it with an approved inert, submitting documentation that EPA approved the inert for the proposed pesticidal uses, correcting mistakes on the eSF, etc. or 2)provide the data to support OPP approval ofthe inert or 3) withdrawthe application. Removing or substituting an inert ingredient will require a new eSF and mayrequire submission ofdata. All information, forms, data and documentation resolving the inert issue must have been received by the Agency orthe application withdrawn -within the 21 day period, otherwise, the Agency will reject the application as described below. To successfully complete this aspect ofthe 21 day initial content screen, applicants are strongly encouraged to verify that all inert ingredients have been approved for the application's uses even 

### if a product is currently registered by consulting the inert Web 3

### site (link to http://www.epa.gov/opprdOOllinerts/lists.html] and ifthe inert is not approved, to obtain the necessary inert approval prior to submitting an application to register a pesticide product containing thatinert ingredient. Some inert ingredients are no longer approved for food uses or certain types ofuses. The name and/or CAS number on a CSF mustmatch the name and CAS number on this web site. Simple typographical errors in the name or CAS number have resulted in processing delays. Ifaninert is not listed on the inert ingredient web site and the applicant believes that the inert has been approved, the applicant should contact the Inert Ingredient Assessment Branch (IIAB) at inertsbranch@epa.govandresolvetheissue. Copies ofthe correspondence with IIAB resolving the issue should accompany the application. All new inerts except PIP inerts are reviewed by IIAB. The IIAB should also be contacted for any questions on what supporting data needs to be submitted for and the Agency's inert review process. Questions on PIP inerts should be directed to the Chiefof Microbial Pesticides Branch [Link to http://www.epa.gov/oppbppdllbiopesticides/contactsbppd.htm]
. \\Then a brand, trade, or proprietary name ofan inert ingredient is listed on a CSF, additional information such as an alternate name ofthe inert, CAS number or other information [link to http://www.epa.gov/opprdOOl/inerts/tips,pdfl must also be included to enable the Agency to determine ifithas been approved. Each component ofan inert mixture (including a fragrance) must be identified, In 

### some cases, the supplier ofthe mixture or fragrance may need to provide this information to the Agency. Prior to the Agency's receipt ofan application, applicants must arrange with a proprietary mixture or fragrance supplier to provide the component information to the Agency orpromptly upon EPA's request. Ifthe inert ingredients in a proprietary blend (including fragrances) cannot or are not identified orprovided within the 21-day content review period, the Agency will reject the application, During the 21 day content review, applicants should submit information to the individual identified by the Agency when the applicant is informed ofan lUlapproved inert, Unapproved Inerts Identified on CSFs All applications except conventional newproducts and PIPs Once an unapproved inert is identified on a CSF, the Agency will contact the applicant with the following options: 1. 

### Correct the application by, for instance, correcting the inert's identity or CAS number, providing documentation that the inert has been approved, or removingthe unapproved inert from the CSF or replacing it with one that is approved for the application's uses; or 2, Submit the information and data needed for the Agency to approve the unapproved inert. Ifthis option is selected and implemented, the Agency may request an extension in the PRIA decision review timeframe to accommodate the inert review/approval process; 4

### 3. Withdraw the application (the Agency retains 25% ofthe full fee for the fee category estimated); or Ifnone ofthese options is selected and implemented by the applicant within the 21 day content reviewperiod, the Agency will reject the application and retain 25% ofthe full fee ofthe category identified. Conventional NewProduct Applications "When the Registration Division identifies an unapproved inert on a CSF with an application for a newproductthat the applicant has not identified as requiring an inert approval (R311, R3l2 or R313), it will contact the applicant with the following options: 1. Correct the application by, for instance, correcting the inert's identity or CAS nrunber, providing documentation that the inert has been approved, or removing the unapproved inert from the CSF or replacing it with one that is approved for the application's uses; or 2. Submit the information and data needed for the Agency to approve the unapproved inert, including any required petition to establish or amend a tolerance orexemption from a tolerance. (This option may change the PRIA category forthe application, which could require a longer decision review time and a larger fee. If additional fees are due, they must be received by the Agency within the 21 day content review period.) 3. Withdraw the application (the Agency retains 25% ofthe full fee for the fee category estimated); or
Ifnone ofthe above options is selected and implemented during the 21-day content-reviewperiod, the Agency will reject the application and retain 25% of the appropriate fee for the newproduct-inert approval category. PIP Applications Whenthe Biopesticide and Pollution Prevention Division identifies an unapproved inert on a PIP CSF and a request to approve the inert does not accompany the application, it will contact the applicant with the following options: 1. Correct the application by, for instance, correcting the spelling or name ofthe inert to that in 40 CFR 174, orproviding documentation that the inert has been approved; or 2. Submit the information and data needed for the Agency to approve the unapproved inert. Ifan inert ingredient tolerance exemption petition is required, the petition mustbereceived by the Agency and the B903 fee paid within the 21 day period. Ifthis option is selected and implemented, the Agency vv:ill discuss harmonizing the timeframe for both actions. 5I 

### 3. Withdraw the application (the Agency retains 25% ofthe full fee for the fee category estimated); or Ifnone ofthe above options is selected and implemented during the 21 day content review period, the Agency 

## will reject the application and retain 25% of the fee.
B. A policy on documentation ofoffers to pay is still being developed, however, for a me-too or fast track (similar/identical) new product, R300 or A530, an application without the necessary authorizations ofoffers to pay 

## will be placed into either R301 or 

### AS31. The Agency recommends that authorizations ofoffers to pay be submitted 

## with other PRIA applications to avoid delays inthe Agency's decision. C. Biopesticide applicants are advised to contact the Agency and discuss study waivers prior to submitting their application to the Agency. Documentation ofsuch discussions should be submitted 

### with the study waiver.



### 6

### RedEagle Tribufos Technical Certification Statement 85678- Catherine Byrd

### ~o Jennifer Brandon 08/12/201012:31 PM

Good afternoon Jennifer, 

### Ihave attached a revised 

### Certification Statementform. Please let me know if

### you need anything else. 

### Thank you, Catherine M. Byrd

W<'Jgne-r Regut.:'ltcry AssO(lates, Inc. P.O. Box 640 7460 LancasterPike, Suite9 Hockessin, Delaware 19707 P: 302.234.2780 F; 302.234.7570 

### www.wagnerreg.com 

# am Ce1liflcafion Statemenl EPA Form 8570·34 signed. pdf

### ) UNITED STATES ENVIRONMENTAL PROTECTILiN AGENCY WASHINGTON, D.C. 20460



### August 10, 2010

OPP Decision Number: D-438264 EPAFile Symbol orRegistrationNumber: 85678-RN Product Name: TRIBUFOS TECHNICAL EPA Receipt Date: 09-Aug-201 0 EPA Company Number: 85678 Company Name: REDEAGLE INTERNATIONAL LLC CHERYL WAGNER WAGNER REGULATORY ASSOCIATES,INC. REDEAGLE INTERNATIONAL LLC 7460 LANCASTERPIKE, SUITE 9, PO Box 640 HOCKESSIN, DE 19707-0640 OFFlCEQF PREVENTION, PESTICIDES AND TOXIC SUBSTANCES



### SUBJECT: Receipt ofRegistration 

### Application Subject to Registration Service Fee Dear Registrant: 

### The Office ofPesticide Programs has received your application and certification of payment. 

## Ifyou 

### submitted data 

## with this application, the results ofthe 

### PRN-86-5 screen will be communicated separately. During the administrative screen, the Office ofPesticide 

### Programs has detennined that this Action is subject to a Pesticide Registration Service Fee as defined in the Pesticide Registration Improvement Act. 

## The Action has been identified as Action Code: R31 0 NEWPRODUCT;NON-FAST TRACK (INCLUDES REVIEWS OF PRODUCT CHEMISTRY;ACUTE TOXIClTY;PUBLlC HEALTH PESTEFFICACy); 

### No additional payment is due at this time. If

## you have any questions, please contact the Pesticide Registration Service Fee Ombudsman at (703) 308-9362.

# Sincerely,7~**~** Front End Processing Staff Infonnation Technology & 

### Resources Management Division

# IFee for 

# Servicel 

# j {880047*-
This package includes the following for Division 

# @ New Registration oAD °Amendment oBPPD @RD 2JStudies? DFee Waiver? 

# I 

# [KJ if 

# Risk Mgr. Dvolpay 

# % Reduction: [ 

# Receipt No. 

# s-I 880047**::====~** 

# EPA File Symbol/Reg. No. 

# I 85678-RN Pin-Punc h Date: LI 

# _8=:../.:::.:.9/..=2-=-0:....:1 O=-----..J 

# D This item is NOT subject to FFS action.

. r\UIUII 

# Requested:

# 1l2...~

# \0 

# I Granted:

# I~?'**\..~** 

# I I ParenVChild Decisions:**c~** 

# Amount Due: 

# $ 

# 'i" S-:-LS;::-,
-

If0J 

# Inert Cle:-Jd for**Ipt~se** If0J 

# Uncleared Inert in Product ReViewer:

# ~ 

# \=:::> --=-:. Date: 

# Ii-
- (6 

# -16 Remarks: 

# I I



# I

# r Print Letter Enter More Information



### N;i.\:V**lr~1(e'ct;0rd,** f-:"':"':"'''c'-:

RecNe'4**t'fit&~** " ' Nlfw'tng'';;di&nt 

# 1"----- J'!eckJv"dDillfe: "":,, 

### ,:,SiGiialU(>7 Ufli6; )0.-_:

## ~---o~ Tracking**~** 

## -) j
-



# FEE 

# FOR SERVICEOnline Payment 

### Step 3: Confirm Payment Thank you. Your transaction has been successfully completed. Pay.gov Tracking Information Application Name: PRIA Service Fees Pay.gov Tracking 10: 2518SSKB Agency Tracking ID: 74131075724 Transaction Date and Time: 08/06/2010 15:33 EDT Payment Summary Address Information Account HolderJ W Name: ames agner 7460 lancaster Billing Address: Pike Billing Address 2: Suite 9 City: Hockessin State I Province: DE Zip I Postal Code: 19707 Country: USA Account Information Card Type: American Express Card Number: ********"**1018 Decision Number: Registration 85678 Number: RedEagle Company Name: Internalional Company

Number: Action Code: R310 

### 1 

## 1213

payment Information PaymentAmount: $4,578.00 Transaction Date 08/06/201 0 and Time: 15:33 EDT



## , 

# . , , , 

# .

. 

# ..

,
, ;, , > 

## " '



## "UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
average hours per response for reregistration and special review activities, including time for reading the instruction and completing the necessary forms. burden estimate or any other aspect ofthis collection ofinformation, including suggestions for reducing the burden to: Director, OPPE Infonnation U.S. Environmental Protection Agency, 401 M Street, S.W., Washington DC 20460. Do not send the form to this address.
8/6/2010 n ......... 1l"
.......DTV

c/o Wagner Regulatory Associates Inc. P.O. Box 640 

### DE

Guideline Reference Number 

## I Guideline Study Name



### Signatu"

# ~Jrx.&jrzC EPA Form 8570-35 (9-97) Electronic and Paper versions available. Submit only Paper version. Tribufos Technical

Name and Title Catherine M. Byrd, Agent for RedEagle International LLC Date 8/6/2010
A<rpnl'v Tnt
........1**T1~h ,-..~-**  •.**~.**

# \~ UNITED STATES ENVIRONMENTALPROTECTION AGENCY 401 M Street, S.W. WASHINGTON. D.c. 20460 Form Approved OMB No. 2070-0060
PaperworkReduction Act Notice: Thepublic reporting burden for this collection ofinformation is estimated to average 0.25 homs perresponse for registration activities and 0.25 hours perresponse for reregistration and special review activities, including time for reading the instruction and completing the necessary forms. Send CGmments rega..ding th:l burden estimate or any other aspect ofthis collection ofinformation, including suggestions for reducing the bmden to: Director, OPPE InformatiOH**~Ianaiemer,tDiv~sivn** \2(:)7), U.S. Environmental Protection Agency, 401 M Street, S.W., Washington DC 20460. Do not send the form to this address.**~ ~**  - - .. - DATA MATRIX Date: 8/6/2010 EPA Reg No.1 File Symbol: 85678-**~ ~** 

# r**~a~I:::2~of3** Applicant's/Registrant's Name and Address: RedEagle International LLC Product:

## --~~.'."- .. 

## :----4

Ingredient: Tribufos

Sip-nature

# ~'YI&jrzC c/o Wagner Regulatory Associates Inc. P.O. Box 640 Hockessin, DE 19707

EPAFonn 8570-35 (9-97) Electronic and Paper versions available. Submit only Paper version. Tribufos Technical 

## l

Force

Name and Title Date Catherine M. Byrd, 

### 8/612010 Agent for RedEagle International LLC
A
.."n
....'**Inf"~nRI** YI
__ r--___.

### ----:;;<"""'" ft !

## Sl!ZZ' 

## \",_",l UNITED STATES ENVIRONMENTALPROTECTION AGENCY 401 M Street, S.W. WASHINGTON, D.C. 20460 Form Approved OMB No. 2070-0060
Paperwork Reduction Act Notice: The public reporting burden for this collection ofinformation is estimated to average 0.25 hours per response for registration activities and 0.25 hours perresponse for reregistration and special review activities, including time for reading the instruction and completing the necessary forms. Send C0mments regarding th" burden estimate or any other aspect ofthis collection ofinformation, including suggestions for reducing the burden to: Director, OPPE InformatiOrl**;Yfrui"ienler.(Div~si0n** 

### 1.2**f~7),:** U.S. Environmental Protection Agency, 401 M Street, S.W., Washington DC 20460. Do not send the form to this address. DATA MATRIX Date: 8/6/2010 EPA Reg No.! File Symbol: 85678- 

# i**~a?** 3.of3 Applicant'sJRegistrant's Name and Address: RedEagle International LLC Product: ,--

## -,---~'--**-~----i**
Ingredient Tribufos c/o WagnerRegulatory Associates Inc. P.O. Box 640 Hockessin, DE 19707 Tribufos Technical

Force Footnotes: 1) Certification ofLimits is provided in the Confidential Statement ofFormula EPA form 8574-4

# ~ft&jr1L- Name and Title Catherine M. Byrd, Agent for RedEagle International LLC Si,gnature EPA Fonn 8570-35 (9-97) Electronic and Paper versions available. Submit only Paper version. Note

Date 8/6/2010

A"'f'nl'v Tnt"
......1**TT~n r<~_"'** 

# Cenmdition with Respect to 

# Label Integrity

, , , ' ) , version: **9/11/02**

### -------~------------------------------------- 

### , , , )) , " 

### , , , 

### I certifY that the information (including, but not limited to, text, tables, and graphics)**coct~ined** 

### in the electronic file identified below by file name and submitted with this 

### certification is the same information as that on the paper copies of these documents included with this submission,

IPROPOSED LABEL 

### Date Submitted EPA Registration 

### # to EPA 

### Electronic file name 

## 85678- 08/06/2010 

### 85678-xxxxx-20 1 00806,pdf

I oertify that the statements that I have made on this form 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
Catherine M. Byrd Name (typed) Agent for RedEagle International LLC Title 08106/2010 

### Date

### August 1,2009



### To Whom It

### May Concern Dear Sir orMadam: 

### Phone: (863) 682-6698 Fax: (863) 682-6690

This letter serves as notification that RedEagle International LLC. has appointed Wagner RegulatoryAssociates, Inc. (WRA, Inc.) to serve as theAgent on oUr 

### company's behalf regarding all state and federal regulatory matters relative to products 

### that RedEagle International LLC. will register 

### with the U.S. EPA and the states. Please forward all correspondence for RedEagJe International LLC. and its products to: Wagner RegulatoryAssociates, Inc. P.O. Box 640 Hockessin, DE 19707-0640 

### Thank you for your time and assistance. Please feel free to ca1J me if

### you have any questions. Respectfully submitted,

# tf**,··/i:~'** 

# .... . . ' .. 

### Yingxue Yu ChiefExecutive Officer cc; 

### WRA, Inc.

, , 

### , , 

# . " , " 

### ,

, , , , " , >, , 

# . , 

## " , " , , • ' > , > 

### • , , 

# .**----------~~--~~~~~--~~~~~~~~~~~~---------- ,,~,>**  Address: 1925 E. Edgewood Drive, Lakeland, Florida 33803 ' o , , 0 ,,' 

### ,**"m~&"** __ ",_"*",,"'-='''''''==WM==_=,,,,_,_,,, ___**m'==---'-""-'"ruw-'--~**

# oo~rn 

# ®[RDaY!**REGIStRATtOH'~** ,0 , 

# &'56''15''-**~** 

# O·



# . ., ."

.. .... I 

# ·.·SJATEMENTOF FORMULA ENCLOSED

PRFORM'a.u (MARCH 2006' 

# Do 

# NotWrite 

# Colfllj1entS, 

# Formula, 

# or Parbiof Formula on This Envelope



# NOTE It shall be unlawful-for any person 

### to ue. for hi_ own advantage or 

### to reveal, other than to the Secretary, or officials or employees of the United States Dspartment of .-,rlculture or other Federel agencies, or to tha courts In response to a subpoena, or to physicians, and In emergencies to pharmacists and other quallffed persons, for use In the preparetlon of antidotes. In accordance with such directions 8S the Seoretary may prescrtbe. any Information relative to formulas of products acquired by authority of Section 4 ofthe "Federal insecticide. FunSfolde, and Rodentfclde Act.
..

USOA·A

## Pages 164
-166
-* Confidential Statement of Formula may be entitled to confidential treatment*