EPA Registration Number 85678-10
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< .'> Draft 3; 10125107 

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EPA Reg. Number: gS67J' - !TN 

FOtnl 8570-1) Included in the . aut and signed 

8570-

is It completely . . 

I'Otnl 8570-

. of Data (EPA X 

. 8570-35) Included in the >( 

Package? >< 

1
Material Sent for Data Extraction 

Reg # ___ '8.::..;50=--1_8,--_' 0 __ 

Descri ption: ____ 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 or jacket. It 

must be well organized and clipped together, NOT STAPLED. 

Then give the material with this coversheet to staff in the 

Information Services Center (Room S-4900). 

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

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

Date: ________ 3~/'-\/_,-'-J ________ _ 

2
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 

Red Eagle 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 of this product by the Agency. In 

order to proted heaRh and the environment, the Administrator, on his motion, may at any time suspend or cancel the registration of a pesticide in 

accordance with the Act. The acceptance of any name in connection with the registration of a product under this Act is not to be conslrued as giving 

the reg·lstrant a right to exclusive use of the 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 of your 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 of this notice. 

The Basic Confidential Statement of Formula (CSF) dated January 26, 2011 is acceptable. 

A stamped copy of the label is enclosed for your records. Submit one (1) copy of the revised final 

printed label before you release the product for shipment. Products shipped after eighteen (18) 

months from the date of this notice or the next printing of the label, whichever occurs first, must 

bear the new revised label. If these conditions are not complied with, the registration will be 

subject to cancellation in accordance with FIFRA §6(e). Your release for shipment of the product 

constitutes acceptance of these 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 2011 

3
85678-10.20110215. 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 of water 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 of water for 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 of the 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 of the 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 of4 

4
8S678-1O.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 of the Environmental Protection Agency. 

Page 2of4 

5
85678-10.20110215. 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 

6
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 

7
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 

8
85678~ 10 t.2011 0215.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 Programs 

9
85678-Tribufos Tech-Vl-06AUG10 Draft LClu~I-lnitial Registration 

Tribufos Technical 

lX'aCcep-t<\b\-e.. - ~ 

COMf'''''':l ~+ "0 

.;? f IS/".,AO , ~ , , 

" " " , , 

" , , , " , 

, 

, " , 

FOR USE IN THE MANUFACTURE OF COTTON DEFOLl~NT$ , , 

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

Active Ingredients: ~'H:> 

T ribufos (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 of water 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 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) 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 of the 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 apart from the choliner~ic effects. 

Page 1 of 4 

10

iO 
85678-Tribufos Tech-Vl-06AUG10 Draft lauel- Init'ral Registration 

Use atropine sulfate to reverse cholinergic symptoms; maintain a systematic, symptomatic 

treatment of the 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 of 2-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 of4 

11
85678*Tribufos Tech*Vl*06AUG10 Draft LGluel* 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 hOt 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 bl 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 4 

12
85678-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: 

Red Eagle International LLC 

1925 E Edgewood Drive 

Lakeland, FL 33803 

Page 4 of 4 

13
UNIl~" STATES ENVIRONMENTAL PROTECTIt)~ AGENCY 

WASHINGTON, D.C. 20460 

February 3, 2011 

CHERYL WAGNER 

WAGNER REGULATORY ASSOCIATES, INC. 

REDEAGLE INTERNATIONAL LLC 

7460 LANCASTER PIKE, SUITE 9, PO Box 640 

HOCKESSIN, DE 19707-0640 

Report of Analysis for Compliance with PR Notice 86-5 

OFFICE OF 

PREVENTION, PESTICIDES AND 

TOXIC SUBSTANCES 

Thank you for your submittal of31-JAN-ll. Our staff has completed a preliminary 

analysis of the material. The results are provided as follows: 

Your submittal was found to be in full compliance with the standards for submission of 

data contained in PR Notice 86-5. A copy of your bibliography is enclosed, annotated with 

Master Record 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. 

14
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 of Pesticide 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 of Amended Study (MRID 48179804) 

Wagner Regulatory Associates, Inc., as agent for RedEagle International LLC, respectfully submits an amended 

study for MRlD 48179804). This study was amended to include viscosity (830.7100) and replaces the previously 

submitted study. 

In support of this 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 

If you 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, , 

15
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 

Chief Executive Officer 

cc: WRA, Inc. 

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

16
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 Of Which 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 ,;, 

17
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

WASHINGTON, D.C. 20460 

Office of Chemical Safety and 

Pollution Prevention 

January 24, 2011 

MEMORANDUM 

Subject: Name of Pesticide Product 

EPA File Symbol: 

DP Barcode: 

Decision No.: 

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% 

18
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 of this 

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 of Tribufos Technical Technical, EPA File Symbol: 85678-RN, claiming substantial 

similarity to DEF Technical Defoliant, EPA Reg. No. 5481-9022. The product was 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 (MRID 4178230 1) submitted to support registration of the 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 of the 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 #: 07480 I, 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 of use sites. The acute toxicity data reviewed for 

registration of 5481-9022 can be bridged to 85678-R N. 

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 of the cited product 5481-9022 does not contain category III precautionary statement 

acute inhalation labeling, which includes the statements "Harmful if inhaled. 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 why this language has been omitted 

from the label of 5481-9022. 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 

19
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 obtained from 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 if absorbed through skin. May be fatal if swallowed. 

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 or using the toilet. Remove and wash contaminated 

clothing before reuse. Avoid breathing spray mist. * 

First Aid: 

If on skin: 

-Take off contaminated clothing. 

-Rinse skin immediately with plenty of water for 15-20 minutes. 

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

If swallowed: 

-Call a poison control center or doctor immediately for treatment advice. 

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

-Do not induce vomiting unless told to by a poison control center or doctor. 

-Do not give anything to an unconscious person. 

Ifinhaled: 

-Move the person to fresh air. 

-If person is not breathing, call 911 or an ambulance, then give artificial respiration, preferably mouth-to-mouth if 

possible. 

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

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

You may also contact 1-800-xxx-xxxx for emergency medical treatment information. 

*Statements in italics are not required based on the accepted label of the 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 of3 

20
BARCODE: 0382143; Reg. No. IFILE SYMBOL No.: 85678-RN- PRODUCT: Tribufos Teclmical 

DATE: 

SUBJECT: 

FROM: 

TO: 

November 22, 2010 

Product Chemistry Review of Tribufos 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 of cotton 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 of the data was conducted by Oak Ridge Laboratories. 

SUMMARY OF FINDINGS: 

I. The registrant has submitted a Confidential Statement of Fonnula for a basic formulation dated January 26, 

2011 (previously dated August 6, 2010) of Tribufos 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 of material 

used to produce the product) satisfy the data requirements of 40CFR§ 158.160 [MRIO No.481798-02]. 

3. The product chemistry data submitted corresponding to guideline reference 830.1620 (description of production 

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 of impurities) 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 of 40CFR§ 158.170 [MRID No. 481798-03]. 

6. The data submitted corresponding to guideline reference 830.1800 (enforcement analytical method) satisty the 

data requirements of 40CFR§158.180 [MRIO No. 481798-03]. 

7. The data submitted corresponding to gUidelines 830 Series Subgroup B (physical-chemical properties) satisty 

the data requirements of 40CFR§ 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 on 

21
BARCODE: 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 of oxidation/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 of the impurities are 

consistent with the preliminary analysis of the batches with the lower % of the active ingredient and thus the 

higher % of impurities. 

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 of oxidation/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 of this 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 of this 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 

22

*Manufacturing process information may be entitled to confidential treatment*
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 

i 

I 

" 

" 

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 or 

23 *Manufacturing process information may be entitled to confidential treatment*
BARCODE: 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 % of initial 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 Submitter states 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 "" waivers 

24
BARCODE: D382143; Reg. No./FILE SYMBOL No.: 85678-RN- PRODUCT: Tribufos Technical 

830.1800. Enforcement analytical method (MRlD 481798-03): 

The submitter incorporated the documentation of the 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 of the certified limits for technical grade tribufos. 

1. INTRODUCTION 

The objective of this study was to detenlline the pUrity of tribufos 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 a contract 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 % 

25
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 SwRI TAP 01-0408-095 Preliminary 

AI/alytlcal Meti/od/o/" Pesticide Products 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. Thesamples were diluted I OO-fold with methylene chloride for purity 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 a DB-5MS 30 m x 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: 30 mUmtn; Air Flow: 400 mUmin;Makeup Gas Type: Nitrogen; N: Flow: 

30 mUmin; Mode: Constant column + makeup 

C. Quantitation, Calculations and Statistical Methods 

Bacb sample was spiked with semi-volatile internal standard at 5 ugfmL final concentration, 

A lineal'curve was llsed for the calculation ofthe tribufos, The Rl for lhe tribufus was greater than 

0.995, Chemstation only lists theX Variable 1 and Intereept at 3 significant figures so thestatislical 

regression for tribufos was generated to show the actual values ofthe X Vllriable I and Intercept for 

calculation purposes, 

26
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 ofthe analytical method was demonstrated by analysis ofa five-point calibration 

CliVC, The percent deviation of the 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 Amt is thecalculated concentration base upon the IinearregressioncUlVc, and Thea Amt 

is the theoretical concentmtlon ofthe standard. 

Y. PROCEDURAL MODIFICATION AND NOTICE 

Two amendments but no study deviation were recordcd during the conduct ofthe study for 

replacing 5-batch testing samples, modifying proposed completion date, lind adding more analysts 

to the project. Additional items as specified in 40 CPR 160. 185.a.(7, 8) are not applicable to this 

study. 

VI. RESULTS AND DISCUSSION 

A. Va1idation of the Analytical Method 

A validation study was perfonncd to detennille the precision of the analytical method for 

tribufos purity, Tribufos TOAI batch #20100326.5# sample testing solution Was prepared, then 

aualyzed in seven replicates by GC/FID, The mean, standard deviation and coefficientofthe testing 

results were thcll calculated. Thcse results are presented in Table 1. 

27
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% of the 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 of quantitation (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 in both 

mbufos analytical s.tandard and in five lots oftrlbufos technical samples, and confirms the identity 

of the active ingredient. 

B. Tribufos TOAr Purity Results 

Purity analysis was performed on five lots oftribufos TOA!, These results are presented in 

Tablc2. Thepercent purity oftribufos was comparable for the five 10tsTOAI samples. Theaverage 

purity for these five lots tribufos TOAl was 100.21 %. 

VU. CONCLUSIONS 

The Analytical method presented here is precise and accurate for the determination of purity 

oftribufos TOAl. Preliminary-analysis of tile 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 

of at least S years following the date on which the results oftile study are submitted to theBPA in 

support of an.application for a research or marketing pelmit. Unused samples will be sent back to 

the sponsor or maintained for a period of at least 5 years foUowing the date on which the results of 

the study are submitted to the EPA in support of an application for a research or marketing pennit. 

IX. REFERENCES 

USEPA, Pesticide Assessment Guidplines Subdivision D, 40 CFR 158, Prodllct Chemistry 

USEPA, pesticide Assessment Ould~lines OPPTS 830 Series, Product Chemistry 

! 

28
BARCODE: D382143; Reg. No. /FILE SYMBOL No. : 85678-RN- PRODUCT: Tribufos Technical 

X. TABLES AND FIGURES 

Table 1~1. Method Validation for Precision of Tribufos 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 of Tribufos 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% 

29
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 of Materials Used to Produce the Product (OPPTS 830.1600) 

Description of the Formulation Process (OPPTS 830.1650) 

Discussion of Formation 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 of Pesticide 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 Order No. 1-26 

Dennis M. Opresko, Ph.D. 

Secondary Reviewers: 

Sylvia Milanez, Ph.D., D.AB.T. 

Robert H. 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 of Energy 

under Contract No. DE-AC05-000R22725, 

38
BARCODE: D382143; Reg. No. /FILE SYMBOL No. : 85678~RN~ PRODUCT: Tribufos Technical 

DATE: 

SUBJECT: 

TO: 

November 22,2010 

Product Chemistry Review ofTribufos Technical 

Name of the Team Reviewer / Name of Risk 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 technical product for formulation use in the manufacture of cotton defoliants. Group A and 

Group B data were submitted for the TGAI. 

SUMMARY OF FINDINGS: 

1. The registrant has submitted a Confidential Statement of Fonnula 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 of 40CFR§158.155 [CSF and 

MRID No. 481798~02]. The following need to be corrected: (a) the nominal concentration of the 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 of the impurities 

and (CSF) are inconsistent with the preliminary 

analysis (MRID 481798~03) and these discrepancies must be resolved; (c) the lower certified limits of the 

impurities must be removed from the CSF; (d) the purity of the TGAI (99.5%) should be removed from colunm 

lOon the CSF; and (d) the spelling of the impurities should be corrected. 

2. The product chemistry data submitted corresponding to guideline reference 830.1600 (description of material 

used to produce the product) satisfy the data requirements of 40CFR§ 158.160 [MRlD No.481798~02]. 

3. The product chemistry data submitted corresponding to guideline reference 830.1620 (description of production 

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 of impurities) 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]. 

2 

39

*Manufacturing process information may be entitled to confidential treatment*
BARCODE: D382143; Reg. No.IFILE SYMBOL No.: 85678-RN- PRODUCT: Tribufos Technical 

6. The data submitted corresponding to guideline reference 830.1800 (enforcement analytical method) satisfy the 

data requirements of 40CFR§ 158.180 (MRID No. 481798-03]. 

7. The data submitted corresponding to guidelines 830 Series Subgroup B (physical-chemical properties) satisfy 

the data requirements of 40CFR§158.190 for color, physical state, odor, stability, pH, density, UV/visible 

absorption, partition coefficient, water solubility and vapor pressure [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 481798-0 I) has requested data waivers for the 

requirements of oxidationlreduction (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). 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 of viscosity (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 of the a.i. on the CSF is not exactly equal to the concentration on the label, and because the 

nominal concentrations and upper certified limits for two of the impurities are inconsistent with the preliminary 

analysis. 

2. Data submitted for color, physical state, odor, stability, pH, density, UV Ivisible 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 in kPA and the BP should be corrected to standard pressure (101.325 kPa). 

3. The submitter has requested data waivers for the requirements of oxidation/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. 

5. The submitter needs to provide a justification 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 if these are equivalent to those recommended in the OPPTS guidelines. 

The submitter needs to verifY that these methods are equivalent to OPPTS recommended methods. 

3 

40
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: Ct2Hn OPS3 

Molecular Weight: 314.5 

Structural formula: 

Table I. Manufacturin and 1m 

GLN Requirement MRID 

830.t550 Product Identity and composition 481798-02 

8301600 Description of materials used to 481798-02 

produce the product 

830.1620 Description of production 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 of the a.i.1isted in 

column 13 of the CSF (99.52%) does not exactly 

match the label concentration (99.5%). The "purity 

"of the TGA11isted in column 10 of the CSF 

N (99.5%) should be removed. An appropriate 

justification is needed for the nominal concentration 

and upper certified limits of the 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 of the fonnation of the impurities was 

i Novided. 

Results of the 5·batch analysis were consistent with 

A the proposed nominal concentration and certified 

limits of the a.i., but not for two of the impurities. 

Certified limits for the TGAI were based on the 

nominal concentration (95.52%) and the 

recommended range of ±3%. The nominal 

N concentrations of the 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 

41

*Manufacturing process information may be entitled to confidential treatment*
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 erties ofTribufos 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% of initial 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 is requested. 

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 data gap. 

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 not required. 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 Boiling point 481798-04 A 166°C at 0.6 mm Hg. The boiling 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 20Q

C; 0,71 mPa at 25 QC, Data from 

published source (Pesticide Manual) 

A"" Acceptable; N "" unacceptable (see Deficiency); N/A = Not Applicable; G = Data gap; I = In progress or need upgrade; U = Up-grade 

(additional information required); W "" waivers 

5 

42
BARCODE: D382143; Reg. No.IFILE SYMBOL No.: 85678-RN- PRODUCT: Tribufos Technical 

830.1800. Enforcement analytical method (MRID 481798·03): 

The submitter incorporated the documentation of the Enforcement 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 of the certifIed limits for technical grade tribufos. 

1. INTRODUCTION 

The objective of this study W35 to detennine the purity of tribufos 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 a contract 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: 

Molecular Wei8ht: 

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 % 

6 

43
BARCODE: D382 143; Reg. No. /FILE SYMBOL No. : 85678-RN- PRODUCT: Tribufos Technical 

Lot # : NTOO695 

Expiration Date: 01/2012 

ill, STUDY PERSONNEL 

Gang Sun. Ph.D., study direclor and project manager 

Michelicl Zuniga, senior research scientist 

John Eric Gomez, technician 

Monica Mendoza, research assistant 

IV. BXPBRIMENTAL 

Tribufos purity analysis was perfonned according to SwRI TAP 01-0408-095 Prelimtllary 

Allofytical Method/or Pesticide Producls by GC/FID and GC/MS, The method was validated for 

precision and accuracy of preliminary analysis, Particular details of the 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 for purity analysis. 

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 oven program was 4O'C for 1.0 minules then 

lO'C/min to 310'C hold for 5 minutes. The following flow rates were used fbr the FIn: Detector 

Temp: 300 'C; !4Flow: 30 mUmin; AirFlow:400 mUmin~MakcupGas Type: Nitrogen; N2 Flow: 

30 mUmin; Mode: Constant column + makeup 

C. Quantitalion, Calculations and Statistical Methods 

Eacb sample was spiked with semt-volatile internal standard at S uglmL final concenlration. 

A linear curve was used for the calculation of tho tribufos. The R2 for Ihe tribufos was greater than 

0,995. Chemstation only lists theXVariable t and Intercept at 3 significant figures so thestatislical 

regression for tribufos was generated to show the actual value. oftheXVariable I and intercept for 

caleulation purposes. 

I. 

7 

44
BARCODE: D382143; Reg. No. !FILE SYMBOL No.: 85678-RN- PRODUCT: Tribufos Technical 

Precision ofthe analytical method was determined by analyzing seven replicate injections 

of sample solutions prepared from a tribufos sample. The mean (X). standard deviation (S) and 

coefficient of variation (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 ofN replicate measurements (N=?). 

Accuracy of the analytlcallnethod was demonstrated by analysis ofa five-point calibration 

curve. The percent deviation of the 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 Calc Amt is the calculated concentration base upon the linear regression curve, and Theo Amt 

is the theoretical concentration of the standard. 

V, PROCEDURAL MODIFICATION AND NOTiCE 

Two amendments but no study deviation were recorded during the conduct ofthe study for 

replacing 5-batch testing samples, modifYing proposed completIon date, and adding more analysIs 

to the project. Additional items as specified in 40 CPR 160.185,a.(7. 8) are not applicable to Ibis 

study. 

VI. RESULTS AND DISCUSSION 

A, Validation of the Analytical Method 

A valIdation study was performed to detennine the precision of the analytical method for 

tribufos purity, Tribufos TOAl batch #20100326-5# sample testing solution was prepared. then 

analyzed in seven replicates by GCIFID, The mean. standard deviation and coefficient ofthe testing 

reslilts were then calculated, These results are presented in Table I. 

8 

45
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 a 2% of the theoretical value. 

Limit of Quantification: The lowest point in calibration curve is used as method 

reporting limit (MRL) here equivalent to about 50% for limit of quantitation (LOQ). Appropriate 

calculations used in the quantitation oftribufos is provided on SwRI TAP 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 

of the active ingredient. 

B. Tribufos TOAl Purity Results 

Plll'ity analysis was performed on five lots oftribufos TGAI. These results are presented in 

Table2. Thepercent purityoftribufos wascomparablc fur the five 10tsTGAI samples. Theaverage 

purity for these five lots tribufos TOAl was 100.21 0/0. 

VII. CONCLUSIONS 

The Analytical method presented here is precise and accurate for the determination of purity 

oftribufos TGAI. Preliminary analysis of the 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 

of at least S years following the date on which the results of the study are submitted to the EPA in 

support of an application for a research or marketing pelll1it. Unused aamples will be sent back to 

the sponsor or maintained for a period of at least 5 years following the date on which the rasults of 

the study are submitted to the EPA in support ofan application for a research or marketing pelll1it. 

IX. REFERENCES 

USEPA, Pesticide Assessment Guidtelines Subdivision D, 40 CFR 158, Product Chemistry 

USEPA, Pesticide Assessment Guid~lines OPPTS 830 Series, Product Chemistry 

I, 

9 

46
BARCODE: D382143; Reg. No./FILE SYMBOL No.: 85678-RN- PRODUCT: Tribufos Technical 

X. TABLES AND FIGURES 

Table 1-1. Method Validation for Precision of Tribufos Analysis 

(Sample m Lot # 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 Accuracy of Trlbufos Analysis 

Tribufos Std, 

SIDl 

STD2 

SID 3 

STD4 

SID 5 

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 

47
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) 

of the 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 of the compensation, if any, 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 of compensation that you propose. 

Sincerely, 

James M. Wagner 

Agent for RedEagle International LLC 

Tel: 302-234-8550 

58
Fw: Amvac Chemical Corporation's Petition to Deny Red Eagle 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 Red Eagle International LLC's Application to 

Register Technical Tribufos 

Dear Ms. Fraser, 

I am following up on my email to you of December 13,2010 on this matter and to the attached email 

from Ms. Doverspike. 

As I noted to you in my email from December, AMV AC is not listed as a data submitter for tribufos on 

the current EPA Pesticide Data Submitters List. Therefore, at the time of Red Eagle's application to 

EPA, RedEagle could not have known that ArvIV AC had or would become the owner of certain tribufos 

data at EPA. At that time the EPA Data Submitters List indicated that Bayer Crop Science owned 

tribufos data. Accordingly, RedEagle submitted a timely offer to pay to Bayer. However, since that time 

we have received the EPA written confinnation of the transfer of certain tribufos data from Bayer 

CropScience to ArvIV AC. Therefore, on behalf of RedEagle International LLC, I have submitted an offer 

to pay letter to ArvIV AC 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 AMY AC. RedEagle has an excellent record of settling 

its FIFRA data compensation obligations. Further, RedEagle contends that the petition by AMV AC is 

without significant merit and requests that the Agency deny ArvIV AC's request in this matter. 

Thank you 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. 

59
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 of the 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 of the petition to submit written 

comments to the Agency. Friday, February 11, 2011 was the 60th day since Red Eagle received the 

hardcopy version of the 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 if you 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 of Beveridge 

& Diamond, p.e, and may be confidential or privileged. The information is intended solely for the use of the 

individual(s) or entity(ies) named above. Ifyou are not the intended recipient, be aware that any disclosure, copying, 

distribution, or use ofthe contents of this message is prohibited. If you 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. 

60
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. 51e 1?5 - R U 

Please let me know if you 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: 202w 789w6034 

Fax: 202· 789w6190 

BEVERIDGE ~ &DIAMOND~ 

CONFIDENTIALITY STATEMENT: This electronic message contains infonnation from the law fum of Beveridge 

& Diamond, P.C., and may be confidential or privileged. The infonnation is intended solely for the use of the 

individua1(s) or entity(ies) named above. If you are not the intended recipient, be aware that any disclosure, copying, 

distribution, or use of the contents of this message is prohibited. If you have received this ewmail in error, please 

notifY us immediately by telephone at (202) 789w6000 or by ewmail reply and delete this message. Thank you. 

61
2010·12·10 Amvac Chemical Corporation Petition to Deny RedEagle International LLC_$ Application to R.PDF 

62
BEVERIDGE ~ &DIAMOND~ 

Bv Electronic And Hand Delivery, 

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 of essential 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's regulations, including 40 C.F.R. Part 152, 

63
BEVERIDGE&DIAMOND,~ 

Leslye Fraser, Esq. 

December 10, 2010 

Page 2 

the Petition Clause of the First Amendment, 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 implementing regulations, 

for RedEagle's reliance on Amvac's tribufos data. As detailed below, RedEagle's offer to 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. In the absence of Amvac's receipt of a 

complete and legally sufficient offer to pay from RedEagle, EPA should deny RedEagle's 

application for registration. 

RedEagle also has failed to satisfy requirements for making a legally sufficient 

compensation offer to Amvac under FIFRA § 3(c)(2)(B) or, to Amvac's knowledge, otherwise 

demonstrating how RedEagle will meet outstanding data requirements for tribufos. Tribufos is 

subject to data requirements under nels issued by EPA in 2000 and 2010, which impose 

significant requirements for additional environmental fate, environmental toxicology, toxicology 

and human exposure data. On a related point, any registration that ultimately is issued to 

RedEagle must be conditioned upon meeting existing data requirements under the same 

deadlines as Amvac. 

Amvac recognizes that RedEagle has the option to 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 is meeting 

any outstanding data requirements by relying on Amvac's responses to the DCls, it must make 

64
BEVERIDGE & DIAMOND", 

Leslye Fraser, Esq. 

December 10, 2010 

Page 3 

an offer to pay Wlder FIFRA § 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 meeting these requirements. 

Factual Background 

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, EPA issued 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-interest to rights in tribufos data that originally were submitted 

by Bayer CropScience ("Bayer"). In July 201 0, Amvac acquired Bayer tribufos registrations and 

supporting data submitted to EPA. On October 6, 2010, EPA fonnally approved the transfer to 

65
BEVERIDGE&DIAMOND~ 

Leslye Fraser, Esq. 

December 10,2010 

Page 4 

Amvac from Bayer of the 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 by the tribufos DCIs. Following acquisition of Bayer tribufos registrations and data, 

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 submitting to EPA a registration application for a technical tribufos product for all uses 

currently approved by EPA (Letter from J. Wagner to Bayer CropScience dated August 20, 

2010, Attachment 4). RedEagle further states that in applying for this registration, it is using the 

"cite-all under selective method of data support." RedEagle's letter did not, however, provide an 

«[i]dentification of the specific data requirement(s) for which the offer to 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. 

On November 15, 2010, Amvac requested in Vlriting that RedEagle promptly correct 

defects in its offer to pay and application by providing Amvac with a copy of the data matrix 

submitted to EPA in support of RedEagle's selective method application.l RedEagle has not 

1 In a prior letter dated October 26, 2010, Amvac informed RedEagle of Amvac's 

acquisition of Bayer tribufos registrations and data and that RedEagle must address its tribufos 

data compensation obligations with Amvac. Amvac has not received any response from 

RedEagle to this letter. 

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December 10, 2010 

Page 5 

responded to Amvac's request for the infonnation required to 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 of certain generally applicable product chemistry data requirements. Amvac bases 

this belief on infonnation available from the National Pesticide Infonnation Retrieval Service 

(''NPIRS''). Amvac does not at this 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 of technical tribufos. However, Arnvac has 

submitted data to satisfy such requirements 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 that they must be 

supported by data. FIFRA § 3(c)(I)(F). UnderFIFRA, a follow-on applicant may cite, and EPA 

may consider, data that were submitted by an original data submitter within the 15 years 

preceding the date of the follow-on application "only if the applicant has made an offer to 

compensate the original data submitter and submitted such offer to the Administrator 

accompanied by evidence of delivery to the original data submitter of the 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 or before the date that is 15 years before the date of the 

67
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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/Data Submitters' Rights, 49 Fed. Reg. 30884, 30889 

(Aug. 1, 1984). Without extending Amvac a proper offer to pay, RedEagle cannot attempt to 

rely on Amvac's data in its own application. 

The protection of an original data submitter's proprietary rights is so fundamental to 

FIFRA's framework that "if [EP A] detennines that an applicant for registration of a product has 

acted in any way that deprives an original data submitter of rights under FIFRA section 

3(c)(1)(F), the Agency will take steps to 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 of protecting the proprietary rights of original 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 

data requirements"); id at § 152.42 (applications must contain the infonnation specified in 

§ 152.50). Indeed," [aJn application is incomplete if any pertinent item specified in § 152.50 has 

not been submitted," 40 C.F .R. § 152.104, and EPA "will not begin or continue the review of an 

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 with the procedures of ... [40 C.F,R. Part 152J subpart [E]." 

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Leslye Fraser, Esq. 

December la, 2010 

Page 7 

49 Fed. Reg. at 30899. The only way that a data submitter can perform this monitoring function 

is if EPA ensures that it is provided a complete offer to pay at the time the follow-on application 

is submitted, that clearly identifies the data requirements applicable to the follow-on product and 

how they are satisfied, as required by EPA's regulations. See generally 40 C.F .R. Part 152, 

Subpart E (establishing "Procedures To Ensure Protection of Data Submitters' Rights," including 

requirements governing selective and cite-all data citation methods, the contents of offers 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 or RedEagle Must Identify How It Otherwise 

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 of all data required 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 rely upon Amvac's existing responses to the two DCls or demonstrate how RedEagle 

intends to otherwise satisfy the DCI's substantial data requirements under the options available 

to RedEagle. 

3. Amvac Is Entitled to Petition EPA to Deny RedEagle;s Tribufos Application 

Amvac is entitled to file this petition pursuant to 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 of Data 

69
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 of tribufos and is responding to the existing nels. As the owner of data 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 not yet issued 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 consider petitions to deny pursuant to the 

Petition Clause of the First Amendment to the United States Constitution.2 Amvac also is 

entitled to petition EPA under the Administrative 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 of an 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., Letter from J. Jones, Director, Registration Division, Office of Pesticide 

Programs, EPA, to J. Wright and J. Liss (June 13,2000) (recognizing the right to petition to deny 

applications under the First Amendment of the Constitution and under FIFRA); Letter from J. 

Jones, Director, Registration Division, Office of Pesticide Programs, EPA, to K. Weinstein and 

E. Ruckert (Sept. 29, 1999) (stating that EPA gives consideration to issues raised regarding 

applications for registration independent of the right to file a petition under 40 C.F.R. § 152.99). i 

, 

, 

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Page 9 

for each data requirement on the list" how that requirement is satisfied. 40 C.P.R. §§ 152.90, 

152.90(b). To satisfy individual data requirements by citing all pertinent studies, which 

RedEagle seeks to do, the applicant must identify to 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 data requirement. (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 cannot know 

whether RedEagle has cited all of the 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. On its face, the offer falls short of requirements under EPA's regulations because it 

fails to identify data requirements for which RedEagle relies on Arnvac' s studies. See 40 c.P.R. 

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

whether RedEagle identifies all data requirements applicable to its product as EPA relies on data 

submitters to do. RedEagle's application must be denied on this basis. 

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Page 10 

2. RedEagie Fails to Make a FIFRA § 3(c)(2)(B) Compensation Offer Necessary 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 conditioned upon the submission or citation of all 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 requirement by 

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 of tribufos, The 

pending data requirements include studies on the environmental fate, environmental toxicology, 

toxicology and human exposure oftribufos. As the successor to 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 

DCI responses, 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 data requirements nor provided Amvac 

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December 10, 2010 

Page 11 

with a Section 3(c)(2)(B) offer to pay, EPA should deny RedEagle's application to 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 of a number of basic 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 identifying the data requirements applicable to its application, 

Amvac cannot identify reliably the data requirements that RedEagle seeks to have waived. Thus, 

Amvac also cannot monitor RedEagle's application in this respect and decide whether to 

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 not possible for 

Amvac to evaluate RedEagle's application and whether there may be other substantive grounds 

under which it is 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 Relief Request 

Amvac respectfully requests that EPA deny RedEagle's application for registration ofa 

technical tribufos product and any related tribufos applications that may be pending. RedEagle's 

offer to pay is deficient on its face in failing to identify: (1) data requirements applicable to 

RedEagle's application; (2) those data requirements for which RedEagle relies on Amvac's 

existing data and DCI responses; and (3) requirements for which RedEagle seeks waivers from 

73
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December 10, 2010 

Page 12 

citing Amvac's data on file with EPA. Allowing RedEagle's application to proceed will deprive 

Amvac of its 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 where the 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 of the applicable data requirements and offer to pay. Amvac should 

be accorded this time to respond because it is required by RedEagle's own failure to properly 

support its application initially by providing the identification of data requirements mandated by 

EPA's regulation at 40 C.F.R. §152,95(h)(2)(ii), 

No Waiver 

In filing this Petition, Amvac does not waive any of the rights available to it in any forum 

to seek further relief under FIFRA or any other source oflaw. 

Thank: you for your consideration. 

Sincerely, 

Michael R. Neilson 

Sarah S. Doverspike 

Counsel for Amvac Chemical Corporation 

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December 10, 2010 

Page 13 

cc: Mr. James Wagner, Wagner Regulatory Associates, Inc. 

Mr. Jim Tompkins, EPA, Office of Pesticide Programs, Registration Division 

Timothy 1. DOIlllelly, Esq., Amvac Chemical Corporation 

75
CERTIFICATE OF SERVICE 

I hereby certify that on this 10th day of December 2010, copies of this 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 of the 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 

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Attachment 1 

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-=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 Hawthorn Road 

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 

This Notice requires you and other registrants of pesticide products containing the active ingrediem( 5) 

identified in Attachment I oftms Notice, the Data CaIHn Chemical Status Sheet, to submit certain 

dataas noted herein to the U.S. Environmental Protection Agency (EPA, the Agency). Thesedataare 

necessary to maintain the continued registration afyour product(s) containing this active ingredient( s). 

Within 90 days after you receive this Notice you must respond as set forth inSection III 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 you believe you areexempt from the requirements listed in this Notice and inAttachment 

3, &quirements Status and Registrant's Response Fonn, (see section III-B); or, 

3. why you believe EPA should not require your submission ofdata in the manner specified by 

this Notice (see section III-D). 

If you do not respond to this Notice, or if you do not satisfy EPA that you will comply with 

its requirements or should be exempt or excused from doing so, then the registration of your product(s) 

subject to this Notice wUl be subject to suspension. We have provided a list of all ofyout products 

subject to this Notice inAttachment 2, Data CaIHn Response F9rm, as well as a list ofall registrants 

who were sent this Notice (Attachment 4), 

The authority for this Notice is section 3(c)(2)(B) of the Federal Insecticide, Fungicide and 

Rodenticide Act as amended (FIFRA), 7 U.S.C. section I 36a(c)(2)(B), and section408(t)(1)(A) of 

the Federal Food, Drug, and Cosmetic Act (FFDC~), 21 U.S.C. section 346a(f){I)(A). Collection 

78
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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 to all Data CalI-In Notices. The Attachmentscontain specific 

chemical information and instructions. The six sections of the Notice are: 

Section I 

Section II 

Section III 

Section IV 

Section V 

Section VI 

Why You Are Receiving This Notice 

Data Required By This Notice 

Compliance With Requirements Of This Notice 

Consequences Of Failure To Comply With This Notice 

Registrants' Obligation To Report Possible Unreasonable 

Adverse Effects 

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 (Insert A) 

Requirements Status And Registrant's Response Form (Insert B) 

List Of All Registrants Sent This Data Call-In Notice 

SECTION l. WHY YOU ARE RECEIVING THIS NOTICE 

The Agency has reviewed existing data for this active ingredient(s) and reevaluated the data 

needed to support continued registration of the subject active ingredient(s) and the continuationofany 

existing tolerances or exemptions for such active ingredient. This reevaluation identified additional 

data necessary to assess the health and safety of the continued use of products containing this 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's Response Fonn (Insert B). Depending on the results of the studies required in this 

Notice, additional testing may bc required . 

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B. SCHEDIILE FOR SUBMISSION OF DATA 

You are required to submitthe data or otherwise satisfy the data requirements specified 

in Attachment 3. Requirements Statu.« and Registrant's Response Fonu (Insert B), 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. 

These EPA Guidelines are available from the National Technical Infonnation Service 

(NTIS), Attn: Order Desk, 5285 Port Royal Road, Springfield, Va22161 (tel: 703-605-6000). 

Protocols approved by the Organization for Economic Cooperation and 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). When using the 

DECO protocols, they should be modified as appropriate so that the data generated by the 

study will satisfy the requirements of 40 CFR § 158. Normally, the Agency will not extend 

deadlines for complying with data requirements when the studies were not conducted in 

accordance with 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 in accordance with 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 

change the requirements of any previous Data CalJ.Jn(s). or any other agreements entered into 

with the AgefEy pertaining to such prior Notice. Registrants must comply with the 

requirements of aU Notices to avoid issuance of a 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 after your receipt of this Notice. Failure to adequately respond to this 

Notice within 90 days of your receipt will be a basis for issuing a Notice ofIntent to Suspend 

(NOIS) affecting your products. This and other bases for issuance of NO IS due to failure to 

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

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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 data requirements imposed 

by this Notice or (5) request a data waiver(s). 

A discussion of bow to respond if you chose the Voluntary Cancellation option, the 

Delete Use(s) option or the Generic Data Exemption option is presented below. A discussion 

of the various options available for satisfying the data requirements of this Notice is contained 

in S~on III-C. A discussion of options relating to requests for data waivers is contained in 

Section Ill-D. 

There are two forms that accompany this Notice of which, depending upon your 

response, one or both must be used in your response to the Agency. These forms are the 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 sign the first page of the DataCall-In Response FOnD (Insert A) and Requirements 

Status and Registrant's ReWQnse Fonn (Insert B) and initial any subsequent pages. The fonns 

contain separate detailed instructions on the response options. Do not alter the printed 

material. If you have questions or need assistance inpreparingyourresponse, call or write the 

contact person identified in Attachment L 

l. Voluntan' Cancellation - You may avoid the requirements of this Notice by 

requesting voluntary caneellationofyourproduct(s)containingtheactive ingredient(s) 

that is the subject of this Notice. If you wish to voluntarily cancel your product, you 

must submit a completed Data Call-In Response Fonn (Insert A), indicating your 

election of this option. Voluntary cancellation is item number 5 on the Data Call-In 

ReSpOnse Fonn (Insert A). If you choose this option" this is the only fonn that you are 

required to complete. 

If you choose to voluntarily cancel your product. further sale and distribution 

of your product afterthe effective date of cancellation must be in accordance with the 

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

2. Use Deletion - You may avoid the requirements of this Notice by eliminating 

the uses of your product to which the requirements apply. If you wish to amendyout 

registration to 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 for amending registrations may be obtained from the Registration Support and 

Emergency Response Branch, Registration Division, (703) 308-8358, 

81
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! 

If you choose to delete the use(s) subject to this Notice or uses subject to 

specific data requirements, further sale, distribution, or use of your product after one 

year from the due date of your 90 day response, must bear an amended label. 

Note: If all registrantsfoT the subject active ingredient respond to this notice 

by requesting cancellation or deletion o/uses all tolerances associated with 

the registration or deleted uses will be revoked pursuant to FFDCA section 

408(/)(2). 

3, Generic Data Exemption - Under section 3(c)(2)(O) ofFIFRA, an applicant 

for registration of a product is exempt from the requirement to submit or cite generic 

data concerning an active ingredicnt(s) if the active ingredient(s) in the product is 

derived exclusively from purchased, registered pesticide products containing the active 

ingredient(s). EPA has concluded, as anexerciseofits discretion, that it nonnally will 

not suspend the registration ofa product which would qualifY and continue to qualify 

for the generic data exemption in section 3(c)(2)(D) ofFIFRA. To qualify, ruJ of the 

following requirements must be met: 

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

wrux because of incorporation of another registered product which contains 

the subject active ingredient(s) and is purchased from a source not connected 

with you; and, 

b. every registrant who is the ultimate source ofthe active ingredient(s) 

in your prodUct subject to this DCI must be in compliance with the 

requiremcnts of this Notice and must remain in compliance; and 

c. you must have provided to EPA an accurate and current "Confidential. 

Statement ofFonnula" for each of your products to which this Notice applies. 

To apply for the Generic Data Exemption you must submit a completed l2!!:g 

Call-In Response Form (Insert A), and all supporting documentation. The Generic 

Data Exemption is item number 6a on the Data Call-In Regwnse FOOD. (Insert A). If 

you claim a generic data exemption you are not required to complete the Requirements 

Status!llld Registrant's Response Form (Insert B), Generic Data Exemption cannot be 

selected as an option for product specific data, 

If you are granted a Generic Data Exemption, you rely on the efforts of other 

persons to provide the Agency with the required data. If the 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 with this 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 cases the Agency generally will not grant a time extension fur 

submitting the data. 

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4. Satisfring the Data Requirements of this Notice w There are various options 

available to satisfy the data requirements of this Notice. These options are discussed 

in Section IIIwC of this Notice and comprise options I through 6 on the Requirements 

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

CallwIn Response Form(lnsert A).lfyou choose option 6b or 7 ,you must submit both 

forms as well as any other infonnationldata pertaining to the option chosen to address 

the data requirement. 

5. Request for Data Waivers. Data waivers are discussed in Section IIIwDofthis 

Noticeand are covered by options 8 and 9 on the Requirements Status and Registrant's 

Response From (Insert B). If you choose one of these options, you must submit both 

forms as well as any other information/data pertaining to the option chosen to address 

the data requirement. 

C. SATISFYING THE DATA REQUIREMENTS OF THIS NOTICE 

If you acknowledge on the Data CallwIn Response FOnn (Insert A) that you agree to 

satisfy the data requirements (i.e. you select option 6b and/or 7), then you must select one of 

the six options on the Reauirement.<; Status and Registrant's Response Faun (Insert A) related 

to data production for each data requirement. Your option selection should be entered under 

item nwnber9, "Registrant Response." The six options related to data production are the first 

six options discussed under item 9 in the instructions for completing the Requirements Status 

and Regjsttant's Response Foon (Insert B). These six options are listed immediately below 

with infonnation in parentheses to guide registrants to additional instructions provided in 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 agreement with one or more registrants to develop data 

jointly (Cost Sharing), 

3. I have made offers to cost~share (Offers to Cost Share), 

4. I am submitting an existing study that has not been submitted previously to the 

Agency by anyone (Submitting an Existing Study), 

5. I am submitting or citing data to upgrade astudy classified by EPAas partially 

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 been submitted but not reviewed by the Agency (Citing 

an Existing Study). 

Option I, Deyelopin~ Data 

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If you choose to develop the required data it must be in confonnance with 

Agency deadlines and with other Agency requirements as referenced herein and in the 

attachments. AU data generated and submitted must comply with the Good Laboratory 

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 test protocols in 

advance of study 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 ofthis Notice, you must submit a detailed 

description of the 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 ofa proposed protocol will not be a basis for extending the deadline for 

submission of data. 

A progress report must be submitted for each study within 90 days from the 

date you are required to commit to generate or undertake some other means to address 

that study requirement, such as making an offer to cost-share or agreeing to share in 

the cost of developing 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, for studies to be started within 12 months of commitment. the name and 

address of the laboratory(ies) or individuals who are or will be conducting the study . 

In addition, if the time frame for submission of a final report is more than I 

year, interim reports must be submitted at 12 month intervals from the date you are 

required to commit to generate or otherwise address the requirement for the study. In 

addition to the other infonnation specified in the preceding paragraph, at aminimum, 

a brief description of current activity on and the status of the study must be included 

as welI as afull description of any problems encountered since the last progress report. 

The time frames in the 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 or protocols. The noted deadlines run from the date of the 

receipt of this Notice by the 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 you cannot submit the data/reports to the Agency in the time required by this 

Notice and intend to seek additional time to meet the requirement(s), you must submit 

a request to the Agency which includes: (l) a detailed description of the 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 

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will respond to your request in writing. If EPA 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 of the registrant. 

Extensions will not be given in submitting the 90-day responses. Extensions will not 

be considered if the request for extension is not made in a timely fitshion; in no event 

shall an extension request be considered if it is submitted at or after the lapse of the 

subject deadline. 

Option 2. Agreement to Share in Cost to Develop Data -

If you choose to enter into an agreement to share in the cost of producing the 

required data but wiII not be submitting the data yourself, you must provide the name 

of the 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 

your letter offering to join in an agreement and the otherregistranfs acceptance of your 

offer, or a written statement by the parties that an agreement exists. The agreement to 

produce the data need notspecif)t all of the terms of the ftnal arrangement between the 

parties orthe mechanism to resolve the terms. Section 3(c)(2)(B) provides that if the 

parties cannot resolve the tenns of the agreement they may resolve their differences 

through binding arbitration. 

Option 3. Offer to Share jn the Cost or Data Deyelopment 

If you have made an offer to pay in an attempt to enter into an agreement or 

amend an existing agreement to meet the requirements of this Notice and have been 

unsuccessful, you may request EPA (by selectingthis option)to exercise its discretion 

not to suspend your registration(s), although you do not comply with the data 

submission requirements of this Notice. EPA has determined that as a general policy, 

absent other relevant considerations, it will not suspend the registration of a product 

of a registrant who has in good faith sought and continues to seek to enter into ajoint 

data development/cost sharing program, but the other registrant( s) developing the data 

has refused to accept your offer. To qualify for this option, you must submit 

documentation to the Agency proving that you have made an offerto another registrant 

(who has an obligation to submit data) to share in the burden of developing that data. 

You must also submit to the Agency a completed EPA Form 8570-32, Certification 

of Offer to Cost Share in the Development ofData. lnaddition, you must demonstrate 

that the other registrant to whom the offer was made has not accepted your offer to 

enter into a cost sharing agreement by including a copy of yom offer and proof of the 

other registrant's receipt of that offer (such as a certified mail receipt). Your offer 

must, in addition to anything else, offer to share in the burden of producing the data 

upon teons to be agreed or failing agreement to be bound by binding arbitration as 

provided by FIFRA section 3(c)(2)(B)(ru) and must not qualify this offer. The other 

registrant must also inform EPA ofits election ofan option to 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. 

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In order for you to avoid suspension under this option, you may not withdraw 

your offer to share in the burdens of developing the data. In addition, the other 

registrant must fulfill its commitment to develop and submit the data as required by 

this Notice. If the other registrant fails to develop the data or for some other reason 

is subject to suspension, your registration as well as that ofthe other registrant will 

nonnally be subject to initiation of suspension proceedings. unless you commit to 

submit. and do submit the required data in the specified time frame. In such cases, the 

Agency generally will not grant a time extension for submitting the data. 

Option 4. Submitting an Existing Study -

If you choose to submit an existing study in response to this Notice, you must 

determine that the study satisfies the requirements imposed by this Notice. You may 

only submit a study that has not been previously submitted to the Agency orpreviously 

cited by anyone. Existing studies are studies which predate issuance of this Notice. 

Do not use this option if you 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 will require you to comply with this Notice, normally without 

an extension of the required date of submission. The Agency may determine at any 

time that a study is not valid and needs to be repeated . 

To meet the requirements of the DCI Notice for submitting an existing study, 

all of the following three criteria must be clearly met 

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a. You must certifY atthe time that the existing study is submitted thatthe 

raw data and specimens from the study are available for audit and review and 

yOll must identifY where they are available. This must be done in accordance 

with the requirements of the Good Laboratory Practice (GLP) regulation, 40 

CFR Part 160. As stated in40 CFR 160.3(7) "rawdatameansany laboratory 

worksheets, records, memoranda, notes, or exact copies thereof, that are the 

result of original observations and activities of a study and are necessary for 

the reconstruction and evaluation of the report of that study. In the event that 

exact transcripts of raw data have been prepared (e.g., tapes which have been 

transcribed verbatim, dated, and verified accurate by signature), the exact copy 

or exact transcript may be substituted for the original source as raw data. Raw 

data may include photographs, microfilm or microfiche copies, computer 

printouts, magnetic media, including dictated observations, and recorded data 

from automated instruments," The term "specimens", according to 40 CPR 

160.3(7), means "any material derived from a test system for examination or 

analysis." 

b. Health and safety studies completed after May 1984 must also contain 

all GLP-required quality assurance and quality control infonnation, pursuant 

to the requirements of 40 CFR Part 160. Registrants must also certifY at the 

time of submitting 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 authorized official or representative of the 

registrant. 

c. You must certifY that each study fulfills the acceptance criteria for the 

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) or meets 

the purpose of the PAG (both available from NTIS). A study not conducted 

according to the PAG may be submitted to the Agencyfor consideration if the 

registrant believes that the study clearly meets the purpose of the PAG. The 

registrant is referred to 40 CPR 158.70 which states the Agency's policy 

regarding acceptable protocols. If you wish to submit the study, you must, in 

addition to certifying that the purposes of the PAG are met by the study, 

clearly articulate the rationale why you believe the study meets the purpose of 

the PAG, including copies of any supporting information or data. It has been 

the Agency's experience that studies completed prior to January 1970 rarely 

satisfied the purpose of the PAG and that necessary raw data are llSually not 

available for such studies. 

If you submit an existing study, you must certify that the study meets 

all requirements of the criteria outlined above . 

If EPA has previously reviewed a protocol for a study you are 

submitting, you must identifY any action taken by the Agency on the protocol 

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and must indicate, as part of your certification, the manner in which all Agency 

comments,. concerns, or issues were addressed in the fmal protocol and study. 

If you know of a 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 

Agencyof StIch astudy. Ifsuch astudy is in the Agency's files, you need only 

cite it along with the notification. Ifnot in the Agency's files, you must submit 

a summary and copies as required by PR Notice 86-5. 

Option 5. Upgrading a Study -

Ifastndy has been classified as partially acceptable and upgradeable, you may 

submit data to upgrade that study. The Agency will review the data submitted and 

detennine if the requirement is satisfied. If the Agency decides the requirement 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. If you have questions regarding the classification of 

a study or whether a study may be upgraded, call or write the contact person listed in 

Attachment I. If you 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 

must provide aclearly articulated rationale of how the deficiencies have been 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 must be in confonnance with PR Notice 86-5. 

Do not submit additional data for the purpose of upgrading a study classified 

as unacceptable and detennined by the Agency as not capable of being upgraded. 

This option shouId also be used to cite data that has been previously submitted 

to upgrade a study, but has not yet been reviewed by the Agency. You must provide 

the MRlD number of the data submission as well as the MRID number of the 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 

submission of data intended to upgrade studies must be accompanied by a certification 

that you comply with each of those criteria as well as a certification regarding protocol 

compliance with Agency requirements. 

Option 6. Citing Existing Studies--

If you choose to cite a study that has been previously submitted to EPA, that 

study must have been previously classified by EPA as acceptable or it must be a study 

which has not yet been reviewed by the Agency. Acceptable toxicology studies 

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

ecological effects studies, the classification generally 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 must provide the MRID number 

of the study you are citing and, if the study has been reviewed by the Agency, you 

must provide the Agency's classification of the study. 

Jfyou are citing a study of which you are notthe original data SUbmitter, yOU 

must submit a completed copy of Certification with Respect to Citations of Data (in 

PR Notice 98-5) EPA Form 8570-34 . 

D. REQUESTS FOR DATA WAIVERS 

There are two types of data waiver responses to this Notice. The first is a request for 

a low volume/minor use waiver and the second is a waiver request based on your belief that 

the data requirement(s) are inapplicable and do not apply to your product 

I. Low VolumeIMinor Use Waiver Option 8 on the Requirements Status and 

Registrant's Response Form (Insert B). Section3(c)(2)(A) ofFIFRA requires EPA to 

consider the appropriateness of requiring data for low volume, minor use pesticides. 

In implementing this provision EPA considers as low volume pesticides only those 

active ingredient(s) whose total production volume forall pesticide registrants is small . 

In determining whether to grant a low volume, mioor use waiver the Agency wiU 

consider the extent, pattern and volume of use, the economic incentive to conduct the 

testing, the importance of the pesticide, and the exposure and risk from use of the 

pesticide. Ifan active ingredient(s) is used for bothhlgh volume and low volume uses, 

a low volume exemption will not be approved. Ifall uses ofan active 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 if any registrant of the active ingredient(s) elects to 

conduct the testing. Any registrant receiving a low volume minor use waiver must 

remain within the sales figures in their forecast supporting the waiver request in order 

to remain qualified for such waiver. If granted a waiver, a registrant will be required, 

as a condition of the waiver, to submit annual sales reports. The Agency will respond 

to requests for waivers in writing. 

To apply for a low volume, minor use waiver, you must submit the following 

information, as applicable to your product(s), as part of your 9()..day response to this 

Notice: 

a. Total company sales (pounds and dollars) of all registered product(s) 

containing the active ingredient(s). If applicable to the active ingredient(s), 

include foreign sales for those products that are not registered in this country 

but are applied to sugar (cane or beet), coffee, bananas, cocoa, and other such 

crops. Present the above information by year for each of the past five years. 

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b. Provide an estimate of the sales (pounds and dollars) of the active 

ingredient(s) for each major use site. Present the above information by year 

for each of the 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 

year for the past five years. Exclude all non-recurring costs that were directly 

related to the active ingredient(s). such as costs of initial registration and any 

data development. 

e. A list of each data requirement for which you seek a waiver. Indicate 

the type of waiver sought and the estimated cost to you Oisted separately for 

each datarequirernent and associated test) of conducting the testing needed to 

fulfill each of these 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 

requirement and associated test) of conducting the testing needed to fulfill each 

of these data requirements. 

g. For each of the next ten years, a year-b~year forecast of company 

sales (pounds and dollars) of the active ingredient(s), direct production costs 

of product(s) containing the active ingredient(s) (following the parameters in 

item c above), indirect production costs of product(s) containing the active 

ingredient(s) (fonowing the parameters in item d above), and costs of data 

development pertaining to the active ingredient(s). 

h. A description of the importance and unique benefits of the active 

ingredient(s) to users. Discuss the use patterns and the effectiveness of the 

active ingredient(s) relative to registered alternative chemicals and 

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

ingredient(s), providing information that is as quantitative as possible. If you 

do not have quantitative data upon which to base your estimates, then present 

the reasoning used to derive your estimates. To assist the Agency in 

detenniningthe degree of importance of the active ingredient(s) in tennsofits 

benefits, you should provide infOrmation on any of the following factors, as 

applicable to your product(s): 

(1) documentation of the usefulness of the active ingredient(s) in 

Integrated Pest Management, (b) description of the beneficial impacts on the 

environment of use of the active ingredient(s), as opposed to its registered 

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IV. 

alternatives, (c) information on the breakdown of the active ingredient(s) after 

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

usefulness against a pest(s) of public health significance. 

Failure to submit sufficient information for the Agency to make a determination 

regarding a request for a low volume minor use waiver will result in denial of the request for 

a waiver. Low volume minor use waivers may not be available for data required for 

continuation of tolerances or exemptions. 

2. Request for Waiver of Data -Option 9 on the Requirement," Status. and 

Registrant's Response FOnD (Insert B). This option may be used if you believe that a 

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

longer registered and no tolerance or tolerance exemption'exists orthe requirement 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, if a current copy ofyout Confidential Statement of Fonnula is not 

already on file you must submit a current copy. 

You will be informed of the Agency's decision in writing. If the Agency 

determines that the datarequiremems of this Notice do not apply to yourproduct(s), 

you will not be required to supply the data pursuant to section 3(cX2)(B) or section 

4(1)(1 XA). If EPA deteoninesthatthe data are required for your product(sj. you must 

choose a method of meeting the requirements of this Notice within the time frame 

provided by this Notice, Within 30 days of your receipt of the 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 FAlLURE TO CQMpL Y WIlli THIS NOTICE 

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

MODIFYING TOLERANCE OR EXEMPTION 

The Agency may issue a Notice ofIntent to Suspend products subject to this Notice 

oran order revoking or modifying associated tolerances ortolerance exemptions due to failure 

by a registrant to comply with the requlrements of this Data Call-In Notice, pursuant to FIFRA 

seetion 3(cX2)(B) or FFDCA section 408(1). Events which may be the basis for issuance of 

a Notice ofIntent to Suspend include, but are not limited to, the following: 

1. Failure to respond as required by this Notice within 90 days of your receipt of 

this Notice. 

2. Failure to submit on the required schedule an acceptable proposed or flnw 

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. 

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4. 

5. 

6. 

7. 

8. 

Failure to submit on the required schedule acceptable data as required by this 

Notice. 

Failure to take a required action or submit adequate information pertaining to 

any option chosen to address the data requirements (e.g .• any required action 

orinfurrnation pertaining to submission or citation of existing studiesor offers, 

arrangements, or arbitration on the sharing of costs or the fonnation of Task 

Forces, failure to comply with the terms of an agreement or arbitration 

concerning joint data development or failure to comply with any tenns ofa 

data waiver). 

Failure to submit supportable certifications as to the conditions of submitted 

studies, as required by Section Ul-C of this Notice. 

Withdrawal of an offer to share in the cost of developing required data. 

Failure of the registrant to whom you have tendered an offer to share in the 

cost of developing data and provided proof of the registranfs receipt of such 

offer. or fail!Jre of a registrant on whom you rely for ageneric data exemption 

either to: 

a, inform EPA of intent to develop and submit the data required by this 

Notice on a Data CalHn Re§pQnse Form (Insert A) and a Requirements Status 

and Registrant's Response Fonn (Insert B); or, 

b. fulfill the commitment to develop and submit the data as required by 

this Notice; or, 

c. otherwise take appropriate steps to meet the requirements stated in this 

Notice. unless you commit to submit and do submit the required data in the 

specified time frame. 

9. Failure to take any required or appropriate steps, not mentioned above, at any 

time following the isSuance of this Notice. 

Events which may be the basis for issuance of an order revoking or modifYing 

associated tolerances or exemptions include. but are not limited to, the following: 

I. Failure to respond as required by this Notice within 90 days of your receipt of 

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. 

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4. Failure to submit on the required schedule acceptable data as required by this 

Notice. 

5. Failure to submit supportable certifications as to the conditions of submitted 

studies. as required by Section lll-C of this Notice. 

6. Failure to take any required or appropriate steps, not mentioned above, at any 

time following the issuance of this Notice. 

B. BASIS FOR DEtERMrNA nON THAT SUBMIITED STUDY IS 

UNACCEPTABLE 

The Agency may determine that a study (even if submitted within the required time) 

is unacceptable and constitutes a basis for issuance of a Notice oflntent to Suspend or an order 

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

include, but are not limited to, failure to meet any of the following: 

I. EPA requirements specified in the Data Call-In Notice or other documents 

incorporated by reference (including, as applicable, EPA Pesticide Assessment 

Guidelines, Data Reporting Guidelines, and GeneTox Health Effects Test Guidelines) 

regarding the design, conduct, and reporting of required studies. Such requirements 

include. but are not limited to, those relating to testmateria~ test procedures, selection 

of species, number of animals, sex and distribution of animals, dose and effect levels 

to betestedorattained, duration of test, and, asapplicable, Good Labonrtory Practices. 

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 of data, including the manner of 

reporting, the completeness of reSUlts, and the adequacy of any required supporting (or 

raw) data, including, but not limited to, requirements referenced or included in this 

Notice or contained in PR 86-5. All studies must be submitted in the form of a final 

report; a preliminary report will not be considered to fulfill the submission 

requirement. 

C. EXlSUNG STOCKS OF SUSPENDED OR CANCELED PRODUCTS 

EPA has statutory authority to pennit continued sale. distribution and use of existing 

stocks of a pesticide product which has been suspended or canceled if doing so would be 

consistent with the purposes of the Federal Insecticide, Fungicide, and Rodenticide Act. 

The Agency has detennined that such disposition by registrants ofexisting stocks for 

a suspended registration when a section 3{ c )(2)(B) data requestis outstanding would generally 

not be consistent with the Act's purposes. Accordingly, the Agency anticipates granting 

registrants pennission to sell, distribute, or use existing stocks of suspended product(s) only 

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in exceptional circumstances. If you believe such disposition of existing stocks of your 

product(s) which may be suspended for failure to comply with this Notice should be pennitted. 

you have the burden of clearly demonstrating to EPA that granting such pennission would be 

consistent with the Act Youmustalso explain why an "existing stocks" provision is necessary, 

including a sfatementofthe quantity of existing stocks and your estimate of the time required 

for their sale, distribution, and use. Unless you meet this burden the Agency will not consider 

any request pertaining to the continued sale, distribution, or use of your existing stocks after 

suspension. 

!fyou request a voluntary cancellation ofyourproduct(s) as a response to this Notice 

and your product is in full compliance with alI Agency requirements, you will have, under 

mostciroumstances, oneyear from the date your 90 day response to this Notice is due. to sell, 

distribute, or use existing stocks. Normally, the Agency will allow persons other than the 

registrant such as independent distributors, retailers and end users to sell. distribute oruse such 

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 

by this Notice will not result 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 of this Notice. For example. if you decide to voluntarily cancel 

your registration six months before a 3 year study is scheduled to be submitted, all progress 

reports and other infonnation necessary to establish that you have been conducting the study 

in an acceptable and good faith manner must have been submitted to the Agency, before EPA 

will consider granting an existing stocks provision. 

SECTION V. REGISTRANTS' OBLIGATION TO REPORT POSSIBLE UNREASONABLE 

ADVERSE EFFECts 

Registrants are reminded that FIFRA section 6(a)(2) states that if at any time after a pesticide 

is registered a registrant has additional factual information regarding unreasonable adverse effects on 

the envirorunent by the pesticide, the registrant shall submit the information to the Agency. 

Registrants must notify the Agency of any factual information they have. from whatever source. 

including but not limited to interim or preliminary results of studies, regarding unreasonable adverse 

effects on man or the environment This requirement continues as long as the products are registered 

by the Agency. 

SEcnON V!. INQUIRIES AND RESPONSES TQ THIS NOnCE 

If you have any questions regarding the requirements and procedures established by this 

Notice, call the contact person listed in Attachment I, the Data Call-In Chemical Status Sheet. 

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

94
• 

• 

• 

exemption claims) must include a completed Da.ta Call~ln Response Form (Insert A) and a completed 

Requirements Status and Registrant's Response Form (Insert B) and any other documents required by 

Ihis Notice, and should be submitted to the contact person identified in Attachment I. If the voluntary 

cancellation or generic data exemption option is chosen, only the Data Ca!Hn Response Fonn (Insert 

A) need be submitted. 

The Office of Compliance (OC) of the Office of Enforcement and Compliance Assurance 

(OECA), EPA, will be monitoring the data being generated in response to this Notice . 

95
• • • 

Attachment 1 

PENDING FLASHER SUMMARY 

PRODUCT: DEF (tribufos) FLASHER NUMBER: 3077 

. c',-, 

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

FLASHER :;0- ',.", 

- DATK,;,;~':'l>:-" -EPA .§l!l;noJti ACTION' 'l!¥n: 

.'.. ',;;,; OiJID1( _-NEEDED BY - COMMENTS DATE DEs'CRimoN ' REQ~- .. ,'.' , .'( >. ' "" jI(Q''''' ,,' "",'~, ti1iL. ", 

10131100 EPA 1) Product Specific DCI for January 16 Included with Interim Re-registration 

Data Call-In 3125-282 DEF 6 2001 Eligibility Decision 

Response 

2) Product Specific DCI for 

3125-96 DEF Technical 

3) Generic DC! for 

3125-282 and 3125-96 

General Comments: This IRED Generic Del appears similar to studies identified with Preliminary RED. 

96
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." 

",Q; 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 .... 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 

97
• 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 

98
• ~ 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. 

99
• • p <<< • 0 • V4 f • 

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 

100
Attachment 2 

101
Bayer CropScience 

September 17,2010 

Ms. Molly Clayton 

Risk Management and Implementation Branch III 

Pesticide Re..evaluation Division (7508P) 

Document Processing Desk (DCIIPRD) 

Office of Pesticidal Programs 

U. S. Environmental Protection Agency 

One Potomac Yard 

2771 South Crystal Drive 

Arlington, VA 22202-4501 

Subject: Tribufos Registration Review Data Call~In 90-Day Response 

Data Call-in ID # RR-074801-30045 

Case#2145DEF 

Dear Ms. Clayton: 

Enclosed with this cover are two fonns required by the 90-day response due 

for the generic data call-in issued by the EPA for tribufos. 

aayer CropSclanc:e 

P.O. Box 12014 

2 T. 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 of the letters sent to notify the Agency of this transfer are appended to this 

cover. Bayer CropScience has notified Amvac that the Agency has issued a data call-in for 

tribufos and provided them with a copy of the DCI. It will be the responsibility of Amvac to 

provide their response to the data call-in. 

If you 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 Corporation 

102
Page 1 of 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) if nea!'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. I wish 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!jree to 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 Status and Regl&tranrs 

Response." Respt'lllse." 

2l>4-72JJ NA NA. 

Il. Certincalion I cerlil)rllult lhe stillt!ments. made OnUlIs form OIfld .!lI.ltilchmllfrts are tfLle. ao::urale. and complele. I al)knllWlodgl! that any 9. OQtc 

knowingly fill$(! Q' misfeooing $Uiromcnl m~y ceo punisbacle c~ fj"e. i'.'Jlpriso~menl orboth under .lI~~~ law. -Pa , . Registration Manager Her lCldes ~ September 17. 2010 SIg"ab.JrG and Title of Company's Aulhor~ed Rt!pre$entatwe • • 

HI. N.vnC 01 Ccrnpilny Bayer CropScience 11. Phont! Nilmt>er 919-549-2582 -- -------

~,.~ ... ------.--.. - --_._-

103
Pag_1 of 1 

United States Eovironmental Protection OMB Appro'''' ~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 in ink.. 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 

R 11. Use 7. Te$. 6. Time S. RI:gLStran! Prog!bS$ -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 Ofaf loxicily 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 by fine, 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. Name of Company Bayer CropScience 13:. Phone Numl.x!r 919-549-2582 

104
Koy: 

Uni1ed States .Envirorunenlw Pnltcclinn 

Agency Washingf(lfl. D.C. 20460 

FOOTNOTES AND KEY DEFINITIONS FOR GUIDELINE 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/the ActlYa lntcgredient or Tel;:l'!nieal End·Use Product; H;A,1 or PA1RA;-

Tectmleal Grade ortheAeti~ lngtl!!dient or A,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' ok pl,u'lts (e.g .. waody ck:cIduous trees and stlWt)$) d[,le to 1m. mechanism or aCUOn. Ava~able loxit«y .$Wdie:!i were 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 thatlhe Agency 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. 

105
Co. Hr. 

"'" 

Company NMne 

Unih.'ti StateS EllviroruneHtal Protc..>c1ion 

Agency Wasllington, D.C. 20460 

LIST Of<' ALL REGISTRANTS SENT THIS 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 

106
Attachment 3 

107
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

WASHINGTON, DC 20460 

~s. ~argaret(jlerny 

Bayer Crop Science LP 

2 T,W, Alexander Drive, P.O. Box 12014 

Research Triangle Park, NC 27709 

Dear Ms. Cherny; 

October 06, 2010 

Office of Prevention, Pesticides 

and Toxic Substances 

Pursuant to your data transfer request dated June 30,2010. and subsequem: information 

received, we have approved the transfer of data ownership from Uayer ( ropScience, company 

number 264, to Amvac Chemical Corporation d/b/a! Amvac, company number 5481. The data 

transfer is effective as of the date of this letter. After this date, Amvac Chemical Corporation d/b/a! 

Amvac company number 5481 will be considered the data owner. We note that no exclusive use was 

transferred with any of this data. Please keep this letter in your records as the EPA does Dot track 

ownership of data in our database. This letter signifies the new ownership. This action will not 

automatically be reflected on the Data Submitters List, Ifyou wish to be added to the Data Submitters 

List. you must submit an additional request to: 

Document Processing Desk (DSL) 

Office of Pesticide Programs (7504P) 

U.s. Environmental Protection Agency 

Ariel Rios Building 

1200 Pennsylvania Avenue, NW 

Washington, DC 20460-0001 

By copy of this letter we are informing the transferor of these changes. If you 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 

Management Division, (1504P) 

Amvac Chemical Corporation 

4695 MacArthur Court, Suite 1250 

Newport Beach, CA 92660-1706 

108
cc: Ms. Meshea Brodie 

Bayer Crop Science LP 

2 T.W. Alexander Drive, P.O. Box 12014 

Research Triangle Park, NC 27709 

2 

109
Bayer Crop Science 

List of Data Transferred from Bayer CropScience LP 

to Amvac Chemical Corporation 

? 0.. 8c.( j.z:;14 

"F. Lt: 2770c 

T.;:I. 91£' ~,,,,::, :<':33 

110
MRID· 

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 study received Apr 20, 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) Supplement to Synopsis of Analytical 

and Residue Information on DEF on Cotton: Supplement No. I. Summary of 

studies 091270-8 through 091270-E. (Unpublished study received Jan 18, 

1969 under 9F0737; 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 study received Jan 18, 1969 under9F0737; 

prepared by Texas A & M Univ., submitted by Mobay Chemical Corp., 

Kansas City, Mo.; CDL:091270-B) No 

Chemagro Corporation (1968) The Effect of Frozen 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 of Agri- 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 of Pharmacological and 

Toxicological Information on DEE Summary of studies 091270-0 through 

091270-1. (UnpubliShed study received Jan 18, 1969 under 9F073 7; 

CDL:091270-P) No 

Murphy, S.D.; DuBois, KP. (1959) Toxicity and anticholinesterase activity 

oftributyl phosphorotrithioate (DEF). American Medical Association 

Archives of Industrial Health 20(Aug): 161-166. (Submitter 4242; 

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 of Pbannacological and ToxicolOgical Infonnation on DEF: Supplement No.1. 

Summary of studies 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 1/1811965 I 

1118/1969 

1/18/1969 

1/18/1969 

111811969 

111
87420 

87421 

87422 

87423 

87424 

87426 

87427 

87428 

116531 

45983 

114023 

Page: 3 of 18 

DuBois, KP. (1964) The Acute Toxicity of Two Samples of S,S,s. 

Tributyl Phosphorothioate to Adult, Female Rats: Submitter 14565. 

(Unpublished study received Jan 18, 1969 under 9F0737; prepared by Univ. 

of Chicago, Dept. of Pharmacology, 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; prepared by Univ. of Chicago, Dept. of Pharmacology, 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 by Mobay 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.; et aI. (l966) The Subacute Dermal 

Toxicity ofTributy1 Phosphorotrithioate (DEF) to Rats: Submitter 19563. 

(Unpublished study received Ian 18, 1969 under 9F0737; prepared by Univ. 

of Chicago, 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 study received Jan 18, 1969 under 9F0737; prepared by Univ. 

of Chicago, 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. of Chicago, 

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 

Bayer CropScienco, P.O. 60:<: 12014, Reseilrch Triang!G Park, North Carolina 27709 

Tei. 919 549-2000 

111811969 

J{18{1969 

III 811969 

lfl8/1969 

1f18tl969 

1tl8{1969 , 

, 

, 

1118/1969 I 

J{18{1969 

213/1970 

7/19f1971 

7{27f1971 

112
41937 

120761 

120762 

120764 

120767 

120768 

120771 

120772 

108533 

49237 

49238 

Page 4 of 18 

Ivey, IL.; Anderson, AL.; Cathey, G. W.; et al. (1973) "CR.) DeE Biological 

Perfonnance of Ultra-low Volume Applications for Defoliation of Cotton and 

Dilute Spmys for Defoliation of Rank Cotton. (Unpublished study received 

May7, 1973 under3125-71; prepared in cooperation with U.S. Agricultural 

Research Service, Delta States Agricultural Research Center, Cotton 

Physiology Research Laboratory and Univ. of Mississippi, 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; prepared by U.S. Fish and 

Wildlife Service, Bureau of Commercial 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 3 I25-71; 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 by U.S. Fish and Wildlife Service, Fish Control Laboratory, 

submitted by 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; prepared by U.S. Bureau of Commercial Fisheries, 

Biological Laboratory, submitted by Mobay Chemical Corp., Kansas City, 

MO; CDL:007020-I) No 

Lamb, D.; Jones, R. (1972) Acute Oral Toxicity ofDEF Technical 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 UL V Simulated 

Field Conditions: Report No: 35030. (Unpublished study received May 7, 

1973 under 3125-71; submitted by Mobay Chemical Corp., Kansas City, MO; 

CDLO07020-P) . No 

Mobar Chemical Corp. (I968) Supplement No.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 of studies 

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 Inhalation Toxicity or. 

DEF Fonnulation to Mice: Report No. 23805. (Unpublished study received 

Mar 22, 1976 under 3 125-71; prepared byUniv. of Cbicago, Toxicity 

Laboratory, submitted by Mobay Chemical Corp., Kansas City, Mo.; 

CDL:224109-C) No 

Bayer CropSclence, P.O. Box 1:<:014. Rosearch Triangle Park. North Carolina 27709 

Tel. 919 549-2000 

SnJI973 

5nJI973 

5nJ1973 

SnJ1973 

5nJ1973 

I 

+-

! 51111973 

i 

15t111973 

I 

+-

5nJ1973 

3122/1976 

3/2211976 

3/2211976 

113
49239 

49240 

49241 

49242 

49243 

49244 

49246 

49247 

49248 

112148 

49252 

49253 

49255 

Page 5 of 18 

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 under 3125- 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 (Without title). N.P. (Submitter report 

no. 31765; also in unpublished submission received 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: Report No. 33127. 

(Unpublished study received Mar 22, 1976 under 3125-71; 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 study received 

Mar 22, 1976 under 3125-71; prepared by Farbenfabriken Bayer, AG, 

submjtted by Mobay 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 study received 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 of Ultra-low Volumc Applications forDefoliation of 

Cotton and Dilute Sprays for Defoliation of Rank Cotton. (Reports by various 

sources; unpUblished study including published data received Mar 22, 1976 

under 3125-71; CDL:224110-A) No 

Mobay Chemical Corporation (1973) Addition to Synopsis ofDEF: 

Biological Performance of Ultra-low Volume Applications for Defoliation of 

Cotton and Dilute Sprays for Defoliation of Rank Cotton. (Reports by 

various sources; unpublished study received Mar 22, 1976 under3125-71; 

CDL:224111-A\ No 

Mobay Chemical Corporation (19721) Synopsis of the 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 study received Mar 22, 1976 under 3125. 282; 

submitted by MobayChemical Corp., Kansas City. MO; COL: 232397-B) No 

University of California, Agricultural Extension Service (19??) Toxicity of 

Pesticides and Other Agricultural Chemicals to Honey Bees: Field Study. 

Riverside, Calif.; UC, ACES. (AXT-251; submitter report no. 21052; also in 

unpublished submission received Mar 22, 1976 under 3125-71; submitted by 

Mobay Chemical Corp., Kansas City, Mo.; CDL:224114-I) No 

Bureau of Commercial Fisheries Biological Laboratory (1966) Bioassay 

Screening Test: Report Nn. 21338. (Unpublished study; CDL:224114'J) No 

Church, D.D.; Shaw, H.R., n (1970) DEF-Leaching, Runoff, and Batch 

Adsorption on Soils: Report No. 26292. (Unpublished study 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 

I 

I 117.?-1I976 I 

I I 

I 

I 

I 312211976 

I 

3122/1976 

3122/1976 

3/22/1976 

312211976 

3/22/1976 

114
49257 

49258 

49259 

113463 

120776 

64378 

49391 

49392 

49393 

49394 

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 

UL V Simulated 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 of Various 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 of S,S,S-Tributyl phosphorotrithioate in cottonseed and cottonseed 

oil. Journal of Agricultural 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 of Analytical and Residue 

Infonnation on DEF on Cotton. Summary of studies 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) A Gas Chromatographic Method for the Determination 

of Residues 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 report nos. 15547, 15548, 

15549 ... , received Mar 22, 1976 under 3125-71; submitted by Mobay 

Chemical Corp., Kansas City, Mo.; CDL:224112-C) No 

Thornton, J. (1966) Detennination of Residues 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 

312211976 

312211976 

312211976 

312211976 

r 3;:;']11976 

I 

t-- I 

I 3,2211976 

r 

I 

I 

312211976 

312211976 

312211976 

312211976 

115
49396 

49397 

49398 

49399 

145267 

144098 

54616 

146338 

144940 

142428 

145268 

80026 

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 Milk by 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 

of Residues 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 of the 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: Report No. 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 Bayer AG. 39 p. No 

Thyssen, 1.; Mohr, U. (I 976) DEF: Neurotoxicity Studies on Hens: Report 

No. 5948. Unpublished Mobay report 47932 prepared by Bayer Ag and 

Medizinische Hochschule Hannover, Abteillung fuer Experimentelle 

Pathologie, W. Ger. 21 p. No 

Francisco (l9??) Pulmonary Exposure of Mice to DEF. Unpublished study. 6 

p. No 

Root, M.j Mcskauskas, J.j Doull, 1. (1967) Chronk Oral Toxicity ofDEF to 

Male and Female Rats. Unpublished Mobay report 20462 prepared by Univ. 

of Chicago, Toxicity Laboratory. 18 p. No 

Thyssen, I.; Schilde, B.j Lorke, D. (I 978) DEF, Studies of Subacute Denn,! 

Neurotoxic Effects on Poultry: Report No. 8081 j 67075. (UnpUblished study 

received Aug 21, 1981 under 3125-282j prepared by Bayer 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; prepared by Bayer AG, 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 

I 

I 9;1411977 I 

9!I·VI977 

11/81l9n 

5/2911979 

8/21/1981 

8/21/1981 

116
80038 

87858 

143630 

143631 

143632 

143633 

143634 

143635 

143636 

143637 

151227 

151228 

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; prepared by Bayer AG, West 

Germany, submitted by Mobay Chemical Corp., Kansas City, Mo.; 

CDL:245781-A) No 

Mobay Chemical Corporation (19??) Pulmonary Exposure of Mice 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 of brain, liver, and plasma 

esterases by on acute dose of S,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) A Laboratory 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 of Potential 

Exposures of Mixer-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. of Food and Agriculture, Div. of 

Pest Mgrnt., Worker Health 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. of Food and Agriculture. Mobay 

No. 68795. 5~_ No 

Hermann, B. (19??) Atmospheric Residues of the Defoliants DEF Folex, and 

Their Sulfur-containing Byproducts near Treated Cotton Fields. Unpublished 

dissertation prepared for requirements for the degree of Doctor of Philosophy 

in the Graduate Division of the 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 of the potential odor contribution ofDEF-6. Prepared by 

Arthur D. Little, Inc. MobayNo.69685. 7p. No 

Thyssen, 1. (1978) DEF: Studies on Acute Inhalation Toxicity (Rats): 80-T014: Report No. 7636. Unpublished Mobay Report No. 66481 prepared by 

BaverAG. ~ No 

Abou-Donia, M. (1978) Study of the Low Level Effects ofOrgaJ;loph08phorus 

Esters with Specific References to the Delayed Neurotoxic Syndrome: 

Quarterly Report 4: Effect of a Single Oral Dose and Subchronic (90-day) 

Oral Administration of Technical 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-tributyl phosphorotrithioate 

(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 

Bayer CropSc[encc, P.O. Box 12014. Rtsellrch Triangle- Park. North Carolina 21109 

Tel. 919 549·2000 

8121!i981 

9110/1981 

9!i8/1984 

9/18!i984 

9/1811984 

9/1811984 

9/18/1984 

~/1!Ul984 I . _. J 

I 

I 

9/18!i984 

9/18/1984 

12120!1984 

12120/1984 

1212011984 

1212011984 

117
151231 

151232 

153410 

164992 

164993 

158402 

158403 

158404 

40190601 

40190602 

40273801 

40436001 

4061}301 

40757101 

41171001 

41459101 

Page 9 of 18 

Abou-Donia, M.; Graham, D.; P .;_ et al. .t~?:~_ Delayed neurotoxic 

and late acute effects of S,S,S-tributyl the hen: Effect 

of route of administration. No 

<?raham, D.; Ab~;~ K.; et~. ~1;79?: I,,, effects :-'1' 

Subchronic . . h"". No 

H'y", K.' tS~dyon.~, : L '~J 1 

~~:~i;:~dy ~::51lp, No 

" _B~~! ; Neurotoxicity Studies on Hens (30-day 

6440. Unpublished Mobay Report No. 90493 'n. 44 p. No 

~oo", K.; S'",o,de<, R;,(~~t ".'" ~ . Method for th' 

ofTribufos in Rr t R~tin if No. 

j by Mobay , 1 Co'P. 261 No 

Lowrimore, , 1 .;_Mattice, J .:::~ ~~~~:~ '?f Non-applicator 

! ~~::~; . ';!_ Crews to 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 in Elsevier 

Science Publishers B. V.- Development in the Science and Practice of 

No 

" R. 

I ~:f: No. 87320. "~par~~~~ Miles Laborato~e~~~c. No 

Clemens, G.; Bare, 1.; Hartnagel, R. (1987) Teratology Study in the Rab,b,it 

with DEF Technical: Rt .,. N . Unpublished study prepared by "'''eO< .• ,100. 120 p. No 

~':'; L,bP';;j;';;No.; 94700. 

'. (DE.'! 

prepared UJ 

.4p. 

., 

No 

Hay", R .. t. ::: ~lD ~ (DEF) in the Mouse: 

Interim 5.~~i~ct: 86-271-01. UnpUblished study prepared I by No 

I ~:~N~I ~ 'M~b~;Co", 5~ 1'0 

" J: S d ~~;; Jab", M .. \1 .; A,.. ) ~'Idl'£ tu y vrrgmlanus : I I e 

. 1 Ltn. . l'l~: 149-127 Unpublished study prepared by 

i i ~Ltd. 101 p. No 

;~';,;!;L ; w, "0. ...o,.~U; / Study 0' .~?~') 

! Con>. 2042 p. No 

?"""', R; G,:"~, P. 

Assay (Ames Test): Lab Project Number 

study prepared by Microbiological Assoc. Inc. 49 

a· No 

Bayer CropSclenco, P.O. Bo)( 12014, Rosearch TriOlngla Park, North Carolina 27709 

Tel. 919 549·2000 

12120/1984 

12120/1984 

10/181I985 

1/10/1986 

IIl01l986 

4/411986 

4/4/:986 

.~'l7rt987 I 

I 

5i7/i987 

7/22/1987 

12/911987 

513/1988 

7125/1988 

712011989 

41l91l990 

118
41459102 

41459103 

92034001 

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Page 10 of is 

Curren, R. (1990) Unscheduled DNA Synthcsis in Rat Primary Hepatocytes: 

Lab Project Number: T8299.380: 1107. Unpublished study prepared by 

Microbiological Assoc., Inc. 26 p. No 

Putman, D.; Morris, M. (1989) Chromosome Aberrations in Chinese Hamster 

Ovary (CHO) Cells: Lab Project Number: 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): 

WlLProject No.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 (Mobay Report 35006). Prepared by Mobay Corp .. 7 p. No 

Cluistenson, w. (1990) Mobay Corporation Phase 3 Summary ofMRID 

41171001. Oncogenicity Study with Technical Grade Tribufos (DEF) with 

Mice: Project: 86-271-01 (Mobay Report 99175). Prepared by 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 .. 34 p. 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) Mobay Corporation Phase 3 Summary ofMRID 

41459103. Chromosome Aberrations in Chinese Hamster Ovary (CHO) 

Cells, DEF Technical: Project T8299.337 (Mobay Report 98592). 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 Rat Primary Hepatocytes, DEF 

Technical: Project T8299.380 (Mobay Report 98576). Prepared by 

Microbiological Associates, Inc. 8 p. No 

Mobay Corporation (1990) Reregistration Phase 3 Response: Tributyl 

phosphorotrithioate. Correspondence and Supporting Material. No 

Talbott, T. (1990) Product Chemistry ofDEF Technical: Lab Project 

Nwnber: VAP0007: JDM0066; 2172. Unpublished study prepared by 

Mob.yemp. 65 p. No 

Talbott, T. (1990) Product Chemistry ofDEF Technical: Lab Project Number: 

9197&: 99857: 99856. Unpublished study prepared by Mobay Corp. 115 p. No 

Talbott, T. (1990) Product Chemistry of DEF Technical: Lab Project Number: 

90606: 94500: 94682. Unpublished study prepared by Mobay Corp. 29 p. No 

Grau, R. (1990) DEF Technical Grade; 5-day Dietary LC50 to Bobwhite 

Quail: Lab Project Number: BV-007: E2950351-5: 100223. Unpublished 

study prepared by Bayer Ag. 36 p. No 

Bayer CropScience, P.O. Box 1:/:014, RMe::m:h Triangle Park, North C~rollna 27709 

Tet. 919 5'49·2000 

411911990 

4/1911990 

512511990 

512511990 

512511990 

512511990 

512<;/1990 

5/.!::i11990 

[ ,a5lI990 

, 

, 

I 5f.t::i11990 

512511990 

5125/1990 

9/411990 

9/4/1990 

9/4/1990 

9/411990 

119
41618805 

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41618808 

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41618811 

41618812 

41618813 

41618814 

41618815 

41618816 

41618817 

41618818 

41689901 

41689902 

Page11O'f18 

Grau, R (1990) DEF Technical Grade: 5-day Dietary LC50 to Mallard 

Duck: Lab Project Number: VE-002: E2970426-0: 100224. Unpublished 

study prepared by Bayer Ag. 43 p. No 

Grau, R (1990) DEF Technical Grade: Acute Toxicity to Bluegill Sunfish in a 

Flow-through Test: Lab Project Number: FB-003: E2860137: 100222. 

Unpublished study prepared by 8ayer Ag. 36 p. No 

Grau, R. (1990) DEF 6: Acute Toxicity to Bluegill Sunfish in a Flow-through 

Test: Lab Project Number: FB-006: E02860355-9: 100219. Unpublished 

study prepared by Bayer Ag. 40 p. No 

Grau, R (1990) DEF Technical Grade: Acute Toxicity to Rainbow Trout in a 

Flow-through Test: Lab Project Number: FF-286: E2810136-1: 100221. 

Unpublished study prepared by 8ayer Ag. 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 

prepared by 8ayer Ag. 39 p. No 

Heimbach, F. (1990) mfIuence of DEF Technical on the Reproduction Rate of 

Water Fleas: Lab Project Number: HBFIRDM29: E3210393-1: 100235. 

Unpublished study prepared by 8ayer Ag. 56 p. No 

Cohle, P. (1990) Uptake, Depuration and Bioconcentration of {Carbon 14)-

DEF by Bluegill (Lepomis macrochirus): Lab Project Number: 38466: 

100236. Unpublished study prepared by Analytical Bio- Chemistry 

Laboratories, Inc. 48 p. No 

Sheets, L. (1990) Dennal Sensitization Study with Technical Grade Tribufos 

(DEp) in Guinea Pigs: Lab ,Project Number: 90-324-GK: 100268. 

Unpublished study prepared by Mobay Corp. 24 p. No 

Hughes. 1. (1990) The Toxicity of DEF Technical to Selanastrum 

capricomutllm (ner 2 Growth and Reproduction of Aquatic Plants): Lab 

Project Number: 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 

prepared by Phannacology and Toxicology Research Laboratory. 41 p. No 

Jackson, S.; Kesterson, A.; Lawrence, L. (1988) Soil Surface Photolysis of 

Carixm 14 DEF in Natural Sunlight: Lab Project Number: 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 and Bioconcentration 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 Project Number: 99630. Unpublished study prepared 

by Bayer AG. 32 p. No 

Heimbach, F. (l990) Acute Toxicity ofDEF 6to Waterfleas (Daphnia 

magna): Lab Project Number; HBF/DM96: E 320 0403-2: 100208. 

Unpublished study prepared 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 

9/411990 

9/411990 

9/411990 

9/4/1990 

9/4/1990 

9/411990 

--

S141I990 

---

S!-J;1990 

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1111 5/1990 

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42007203 

42007204 

42007205 

42007206 

42034501 

42034502 

p;"ge 12 of 18 

Carpenter, M. (1990) 'Detennination of the Aqueous Photolysis Rate ofDEF': 

Lab Project Number: 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 Project Number. 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 by Mobay Corp. 45 p. No Gagli~o, G. (1991) Acute Toxicity ofDEF Teclmical to the Sheep-Shead 

Mirmow (Cyprinodon variegatus) Undcr Flow-Through Conditions: Lab 

Project Number: DE83 1201 : 101240. Unpublished study prepared by Mobay 

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 Project Number: 90-025-FE: 100698. 

Unpublished study prepared by Mobay Corp. 20 p. No 

Sheets, L. (1991) Acute Oral Toxicity Study with Technical Grade Tribufos 

(DEF) in Rats: Lab Project Number: 90-012-ES: 100697. Unpublished study 

prepared by Mobay Corp. 20 p. No 

Sheets, 1.; Phillips, S. (1991) 2 I-Day Dermal Toxicity Study with Technical 

Grade Tribufos (DEF) in Rabbits: Lab Project Number: 90-125-FP. 

Unpublished study prepared by Mobay Corp., Toxicology Dept. 445 p. No 

Sheets, L. (1991) Subchronic Delayed Neurotoxicity Study with Technical 

Grade Tribufos (DEF) in Hens: Lab Project No: 89-428-CS. Unpublished 

study prepared by Mobay Corp., Toxicology Dept. 189 p. No 

Christenson, W. (1991) Chronic Feeding Toxicity Study of Technical Grade 

Tribufos (DEF) with Dogs: Lab Project Number: 88-274-AB. Unpublished 

study prepared by Mobay Corp., Toxicology Dept 585 p. No 

Stevenson, T.; Leimkuehler, W.; Mathew, A. (1991) The Metabolism of 

Tribufos in Soil Under Aerobic 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 Project Number: 100333. UnpUblished 

study prepared by 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) Disposition and Metabolism 

of Carbon 14 ·Tribufos in Rats: Lab Project Number: 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 Project Number: DE04050 I: 101329. Unpublished Study prepared 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 

211311991 

5131/1991 

5/31/1991 

513111991 

7125/1991 

712511991 

?1J5!l991 

9/6/1991 

,9/6/1991 

, 

9/6/1991 

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42350003 

42350004 

42350005 

42350006 

42350008 

42350009 

Page 13 of '13 

Sabali, Y. (199I) Metabolism of Carbon 14 ·Tribufos in Lactating Goats: 

Lab Project Number: 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 Project Number: 88~71- AK. Unpublished 

study prepared by 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, Crassostrea virginica: 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 Project Number: 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 Project Number: 88-271·AA. Unpublished study prepared by Miles Inc. 

3672 p. No 

Talbott, T. (1987) Henry Constant ofDEF Pure Active Ingredient. 

UnpUblished study prepared by Mobay Chemical Corp. 5 p. No 

Krolski, M.; Bosnak, L. (1992) Additional Characterization of Metabolites 

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 Project Number: 

91-722·KW. Unpublished study prepared by Miles, Inc, 54 p. No 

Schocken. M.; Parker, G. (1987) Leaching of Aged Soil Residues ofDEF in 

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.; et al. (1989) Development of an 

Analytical Method for DEF and Dibutyldisulfide Residues in Soil: Lab 

project Number: DE 12210 1: 14 7W. Unpublished study prepared by PTRL 

West. 35 p. No 

Grace, T. (1990) Freezer Storage Stability ofTribufos and Dibutylsulfide in 

Soil: Lab Project Number: 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 Project Number: DE41601: 102639. Unpublished study prepared 

by Miles, Inc. 87 p. No 

Bayer CropScience, P.O. Box 12014, Research Triangle Park, North Carolina 27709 

Tel. 919 549-200n 

9126/1991 

1011/1991 

1011/1991 

10/111991 

11/6/1991 

1/3011992 

4122/1992 

611.d992 

611111992 

1611111992 

, 

I 611 111992 

611111992 

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42799001 

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Page 14 af 18 

Hall,1. (1992) The Metabolism of {Carbon 14) and (Sulfur 35) Tribufos in 

Laying Hens: Lab Project Number: 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: Lab Project Number: DE041 001: 101330-1. Unpublished study 

prepared by Miles, Inc. 114 p. No 

Gronberg, R.; Murphy, 1, (1992) Requirements for Animal Residue Methods, 

Animal Feeding Studies, and Meat, Milk and Egg Tolerances for Tribufos: 

Lab Project Number: 103201. Unpublished study prepared by Miles, 

Inc. 24 p. No 

Fontaine, 1. (1992) Supplement to MRID 41618803: Product Chemistry of 

DEF Technical: Lab Project Number: BR 1804. Unpublished study prepared 

by Miles Inc. 6 p. No 

Pauluhn, J. (1992)DEF (Cornmon Name: Tribufos); Study of the Subchronic 

Inhalation Toxicity to Rats in Accordance with OECD Guideline No. 413: 

Lab Project Number: 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 study prepared by Miles, Inc. 18 p. No 

Christenson, W. (1992) Technical Grade Tribufos (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 with DEF 6 in Rats: 

Lab Project Number. 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·Hour Inhalation 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 of Worker Exposures to Tribufos During 

Aerial and Ground Applications ofDEF 6 to Cotton: Lab Project Number: 

DE202301: 103889. Unpublished study prepared by MILES, Inc. 334 p. No 

Eberhart, D.; Ellisor, G. (1993) Evaluation of Worker Exposure to Tribufos 

During Harvesting of Cotton Treated with DEF 6: Lab Project Number; 

DE202302: 105103. Unpublish.ed study prepared by Miles Inc. 307 p. No 

Bajzik, M, (1992) The Independent Laboratory Method Validation for the 

Analysis ofTribufos in Cottonseed and Soapstock: Lab Project Number; 

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 prepared by 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; DEI4160 I; 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 

6/1111992 

6/11/1992 

7(})1992 

7/14/1992 

712111992 

, 1/\1/1992 

31211993 

::.1211993 

, 

, I 312/1993 

3/3/1993 

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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) in Guinea Pigs: Lab Project Number: 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 prepared by 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 Project Number: DE040301. Unpublished study prepared 

by Miles Inc. 84 p. No 

Valadez, S.; Dehart, B.; Cain, K. (1993) Field Dissipation of Tribufos on 

Georgia Soil: Lab Project Number: 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 Project Number: 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 of Residue in Cotton Processed 

Products: Lab Project Number: DEI9CTO I: 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 Project Number: 107104: DE06040 1: DE130401. Unpublished 

study prepared by Bayer Corp. 508 p. No 

Krolski, M. (1995) DEF 6EC-Magnitude of the Residue on Cotton: Lab 

Project Nwnber: 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 

Detennination ofTribufos 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 Project Number: 107182: 95-324-EJ. Unpublished study 

prepared by Bayer Corp. 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 of the Residue in Cotton Processed 

Products: Additional Information Requested by EPA: Addendum 1: Tribufos: 

Lab Project Number: DEI9CTOI: 106988·1. Unpublished study prepared by 

Bayer Corp. 7 p. No 

B;;yer CropScl!mce, P.O. Box 12014. Research Triangle Park. North Carolina :zn09 

Tel. 919 549-2000 

7/16/1993 

8/20/1993 

8120/1993 

111111994 

81311994 

8/311994 

!:i/3/1994 

8/3/1994 

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, 

. 

11012011995 

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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 Project Number: 

107511: DEI10201: AOI2.022. Unpublished study prepared by Maxim 

Technologies, Inc. 61 p. No 

Krolski, M. (1997) DEF 6 EC--Magnitude of the Residue on Cotton: Lab 

Project Number: DE19CT03: 107903: 105026. Unpublished study prepared 

by Bayer Corp. 270 p. No 

Krolski, M.; Mattern, G.; Lemke, V. et at. (1998) Additional Comments on 

the Chapters of Reregistration Eligibility Decision Document for Tribufos 

(DEF): Lab Project Number: 108756. Unpublished study prepared by Bayer 

Corporation. 96 p. No 

Wills, M. (2000) A DermallIntravenous 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 Project Number: DE231601: 108708. 

unpublished study prepared by Bayer Corporation. 57 p. No 

Sheets, 1.~ Gilmore, R (2000) An Acute Oral Neurotoxicity Screening Study 

with Technical Grade Tribufos (DEF) in Wistar Rats: Lab Project Number: 

98-412-WF: 109802. Unpublished study prepared 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 Project Number: 

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 in Rodent Ration Using Purina Mills Rodent Lab Chow 

5001-4 Etts: Lab Project Number; 99·H72·AL: 9464: 109070. Unpublished 

study prepared by Bayer Corp. 13 p. No 

Fontaine, 1. (2001) Product Chemistry ofDEF Technical: 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·0460 I: ANR-04701: 605041. Unpublished study 

prepared by Bayer Corporation. 47 p. No 

Sheets, L. (2001) A Developmental Neurotoxicity Screening Study with 

Technical Grade Tribufos (DEF) in Wistar Rats: Lab Project Number: 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. 8 p. {OPPTS 830.6317} No 

Lake, S. (2001) A Developmental Neurotoxicity Screening with Technical 

Grade Tribufos (DEF) in Wistar Rats: Lab Project Number: OO-D72-AG: 00· 

! ~72'AS. unpublb~hed study prepared by Bayer Corporation. 1281 p. 

OPPTS 870.6300 No 

Bayer CropSclenco, P.O. Box: 12014, Ros"'iilrch Tri.mglo Park, North Carolina 27709 

Tel. 919 549·2000 

411211996 

&17/1996 

12/811997 

121711998 

111812000 

712612000 

Fi1112000 

---

4/412001 

, i 4/412001 

711212001 

711212001 

8/7/200! 

911412001 

911812001 

125
45539701 

45539702 

45863701 

45863702 

45863703 

45863704 

45863705 

45863706 

45863707 

45863708 

46019901 

47958201 

149213 

142425 

Page 17 of 18 

Fontaine, L. (2001) Product Chemistry ofDEF Technical Defoliant: Lab 

Project Number: 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. (200 I) Product Chemistry ofDEF Teclmical Defoliant: Lab 

Project Number: 110682. Unpublished study prepared by Bayer Corporation. 

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 Project Number: 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 (Pimephales promelas): Lab Project Number: DE841201: 200308. 

Unpublished study prepared by Bayer Corporation. 79 p. No 

Bowers, L. (2002) Tier 2 Seedling Emergence and Vegetative Vigor 

Nontarget Phytotoxicity Study Using DEF 6: Lab Project NlUllber: 

DE45160 I: DE451602: 200245. Unpublished study prepared by Bayer 

Corporation. 105 o. No 

Kern, M.; Lam, C. (2002) Toxicity ofTribufos Technical to Duckweed 

(Leoma gibba 03): Lab Project Number: DE88370 I: 200301. Unpublished 

study prepared by Bayer Corporation. 45p. No 

Kern, M.; Lam, C. (2002) Acute Toxicity ofTribufos Technical to the 

Fathead Minnow (pimpepbales promelas) Under Flow-Through Conditions: 

Lab Project Number: DE831202: 200144. Unpublished study prepared by 

Bayer Corporation. 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 Project Number: 149A-134: DE842801: 200336. 

Unpublished study prepared by Wildlife International, Ltd. 82 p. {OPPTS 

850.1400) No 

Macb, I. (2002) Tribufos: Acute Dietary Toxicity Test with the White-Footed 

Mouse (Peromyscus leucopus): Final Report: Lab Project Number; 02005: 

DE73260 I: 110770. UnpUblished study prepared by Genesis Labomtories, 

Inc. 91 p. {OPPTS 850,2200} No 

Fontaine, L. (2003) Product Chemistry ofDEF Technical Defoliant Project 

Number: 02S009, G20043I. Unpublished study prepared by Bayer Corp. 49 

I p. No 

Matlock, D.; Lam, C. (2010) Early Life Stage Toxicity ofTribufos Technical 

to the Fathead Minnow (pimephales promelas) Under Flow-Through 

Conditions. Project Number: EBTRLOO I, M/360947/0 Ill. Unpublished 

study prepared by Bayer CropScience. 96 p. No 

Thyss,en, J.; Mohr, V.; Lorke. D. (1978) DEF: Subacute Inhalation Study on 

Rats: Report No. 7649. Unpublisbedstudy prepared by Bayer AG. 63 p. No 

Crawford, C. (1971) Treatment Studies 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 

11/21200 I 

lI12f200 I 

2/412003 

2/4/2003 

2/412003 

2/4/2003 

7j4~003 

-

1 7!1t12!103 

i 

! 

I 2"V1003 

2/4/200) 

6/2412003 

lI2012010 

126
144939 

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 of Mice. Unpublished Mobay report 

21543 prepared by Univ. of Chicago, Toxicity Laboratory. 7 p. No 

Chemagro Corporation (1968) Residue ofDEF : Report No. 21889. 

(Compilation; unpublished study including report no. 21892, received Mar 22, 

1976 under 3125·71; submitted by Mobay Chemical Corp., Kansas City, Mo.; 

CDL:224112-K) No 

SheetS, L.; Gilmore, R. (1999) Verification of Personnel Training to Perform a 

Functional Observational Battery with Rats: Lab Project Number: 97-962-LG. 

Unpublished study prepared by Bayer Corporation. 94 p. No 

Smead, C.; Macke, M. (2010) Material Accountability ofTribufos (DEF) 

Technical: Analytical Profile of Five Batches. Project Number: 

Ml366585101/l/0CR, 901571/0CR. Unpublished study prepared by Bayer 

CropScience. 53 p. No 

Wahle, B. (2000) An Experimental Functional Observational Battery 

Validation Study with Carbaryl in Wistar Rats: Lab Project Number: 99-N82-

! ~? 109406. un~~~liShed study prepared by Bayer Corporation. 102 p. 

OPPTS 870.6200 No 

8~yer CropScience, P.O. BOl( 12014, Research Triengll! Park, North Carolina 27709 

T!ili. 919 549·2000 

127
, 

) 

Attachment 4 

128
VIA CERTIFIED MAIL 

August 20, 2010 

Bayer Cropscience LP 

2 T. W. Alexander Drive 

Research Triangle Park, NC 27709 

:illi~1:~> W~gMT ReClllatory WI~}\ 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 

Product Registration 

Dear Sir or Madam: 

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 

FIFRA Section 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 whi ch this applicatioll relies. RedEagle offers to begin 

negotiations to detennine the amount aud tenus of the 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 

Agent fol' RedEaglc Iutel'national LLC 

129
August 6, 2010 

Document Processing Desk (REGFEE) 

ATTN: Jim Tompkins, PM Team 25 

Registration Division 

U.S. Environmental Protection Agency 

Office of Pesticide Programs (7504P) 

Room S-4900, One Potomac Yard 

2777 South Crystal Drive 

Arlington, Virginia 22202-450 I 

Dear Mr. 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 of the 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 of this 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 of Data (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 of the EPA approved label for EPA Reg. No. 264-720 and 

• A copy ofthe receipt continning payment of the required registration fees. 

RedEagle International LLC has submitted payment to U.S.EPA in accordance with PRJA II Fee TableFY09IFYIO, for action category R3IO - $4,578. 

If you have any questions about this submission please contact the undersigned. 

Respectfully submitted, 

Catherine M. Byrd 

Agent for RedEagle International LLC 

Enclosures 

130
1. 

DATA TRANSMITTAL DOCUMENT 

Name and Address of Submitte;r 

RedEagJe International LLC 

c/o Wagner Regulatory Associates 

PO Box 640 

Hockessin, DE 19707 

2. RegulatorY Action In Support Of Which This Package Is Submitted 

3. 

4. 

Application for Registration 

Tribufos Technical 

Transmittal Date 

August 6,2010 

Ust of Submitted 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"'"wagner Regulat;Ty Associates,-fuc. (2010) Tribufos Teclmical~Product 

fdentity and Composition, Description of Beginning Materials, Manufacturing Process, 

48179802 and Discussion ofFonnation ofTmpurities. RedEagle Intemational LLC, Lakeland, 

Florida. Non-confidential portion 6 pages, Confidential portion 57 pages. 

'--'-'-"---'-"'01. 3:' Sun, Gang (2010) PreJin"rirullY A~laly~is ofTribufos Technical Grade Active 

48179803 Ingredient. Southwest Research Institute, San Antonio, Texas. RepOit Number 

01.14990.02.001. Non-confidential portion 19 pages, Confidential portion 16 pages . 

. ~--------.-" .. - Vol. 4~'-'Sun'~ Gang (20l0j~ Trib-ufos Technical Grade Active Ingredient Physical and 

48179804 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 Regulatory Associates, Inc. 

Agent for Red Eagle International LLC 

Catherine M. Byrd 

Name 

Signature 

(302) 234-2.'80 

Phone 

131
Form Approved OM 05.20 . " 

BN 700060 070-05 o 7: 2 070-01072070012220700164 , , 

/'~ 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.:<:ssnry fOIms. Scud 

commo:OIS rcgardingburdenestimate orany OIllCf IISp'.: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 of Data 

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 reoresentaliva lem 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: If your prOlluct is a 100%, repackaging of another 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 of support (or cite-all option 

a fist of companies sentoffel'll of compensation (Ihe Data Matrix form under the 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 or when using the die-ali op~on under Ihe selective melhod 10 satisfy one or more dala requirements! 

0 t hereby offer and 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 

subslantially similarprooud, or one or more of the ingredients in Ihis producl; and (2) is a Iype of data 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 of the Original dala submillerlo cite that study. 

t certify llrat for 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 of the original data submilter 10 use Ihe study in support of Ihis application: (c) all periods of eligibilily 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> of compensation, If any, to be paid forlhe use of\he study. 

I certify \hal in all instances where an offer of compensa~on is required, copies of aU 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 I fail 10 produce such 

evidl!nce \0 Ihe 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 that the i1itDwmentli t havo made on this 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 

OaJ06f20 to CatheriIle M. Byrd, Agenl 

EPA Form 8570-34 . (12 2003) Electronic and Paper vernlons ava~abte. Submit only Paper version . 

132
Please read instructions on reverse before com·-'"~If!gform. Form Approv~-<, OMS No. 2070·0060, Aooroval expires 05-3t·98 

I X agist ration 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 ot Applicant (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 if this 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 letter dated 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 for identification of individual to be contacted, if necessa , to processJliJis"appljcation. 

Name I Title I Teleph9'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. 

133
/' ~ Form Approved OMB No. 2070-0060 f .ft. l \~' UNITED STATES ENVIRONMENTAL PROTECTION AGENCY ,...,..';/ 401 M Street, S.W. 

WASHINGTON, D.C. 20460 

Paperwork Reduction Act Notice: The public reporting 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 of this collection of information, including suggestions for reducing the burden to: Director, OPPE Information Management Division (2137), 

U.S. Environmental Protection Agency, 401 M Street, S.W., Washington DC 20460. Do not send the form to this address. 

DATA MATRIX 

Date: 8/6/20 I 0 EPA Reg No.1 File Symbol: 85678- I Page 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 of Formulation 

ProcesslDiscussion of Formation ofhl1purities 

830.1700 Preliminary Analysis RedEagle International LLC Own 

830.1750 Certification of Limits 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 UV Nisible 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 

134
." Form Approved OMB No. 2070-0060 'ez) 

~.-,,' 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 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 other aspect ofthis colIection of information, 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: 8/6/20 I 0 EPA Reg No.1 File Symbol: 85678· . _~_j_Ea~e~~?f3 o 0 • 

" 

. 

Applicant'slRegistrant's Name and Address: Red Eagle 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 

135
.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 of information is estimated to average 0.25 hours per response for registration activjties an4,0.25. 

hours per response 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 of this collection of information, including suggestions for reducing the burden 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 of Limits is provided in the Confidential Statement of Formula 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'nnv 

136
August 6, 2010 

Document Processing Desk (REGFEE) 

ATTN: Jim Tompkins, PM Team 25 

Registration Division 

U.S. Environmental Protection Agency 

Office of Pesticide 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" 

Wagner Regulatory Associates, Inc., as agent for RedEagle International LLC, is requesting registration of the 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 of this 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 of Formula (8570·4), 2 copies 

• Certification with Respect to Citation of Data (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 of the EPA approved label for EPA Reg. No. 264·720 and 

• A copy of the receipt confirming payment of the 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. 

If you have any questions about this submission please contact the undersigned. 

Respectfully submitted, 

Catherine M. B)Td 

Agent for RedEagle International LLC 

Enclosures 

137
1. 

2. 

3. 

4. 

DATA TRANSMITTAL DOCUMENT 

Name and Address of Submitter 

RedEagle International LLC 

cIa Wagner Regulatory Associates 

PO Box 640 

Hockessin, DE 19707 

Regulatory Action In Support Of Which 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 of Beginning Materials, Manufacturing Process, 

and Discussion ofFonnation of Impurities. RedEagle Intematlonal LLC, Lakeland, 

Florida. Non-confidential portion 6 pages, Confidential portion 57 pages. 

Vol. 3: Sun, Gang (2010) Preliminary Analysis ofTribufos Tecllllical Grade Active 

Ingredient. Southwest Research Institnte, San Antonio, Texas. Repolt Number 

01.14990.02.00 L 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: 

.. . Name Phone · . , · > > , , > 

· ) , > , . , > 

, , , > 

", , 

138
R 310 

Must submit Group A and B product 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 of formulation 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 

139
R 310 

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 

2 

140
Print Letter 

Enter More InformmJon 

Tracking 

141
August 6, 2010 

Document Processing Desk (REGFEE) 

ATTN: Jim Tompkins, PM Team 25 

Registration Division 

U.S. Environmental Protection Agency 

Office of Pesticide 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" 

Wagner Regulatory Associates, Inc., as agent for RedEagle International LLC, is requesting registration of the 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 of this 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 of Data (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 of the EPA approved label for EPA Reg. No. 264-720 and 

• A copy of the receipt confinning payment of the 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. 

If you have any questions about this submission please contact the undersigned. 

Respectfully submitted, 

Catherine M. Byrd 

Agent for RedEagle International LLC 

Enclosures 

142
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 Of Which 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 of Beginning Materials, Manufacturing Process, 

48179802 and Discussion of Formation of Impurities. RedEagle Intemational LLC, Lakeland, 

Florida. Non~confidential portiOll 6 pages, Confidential portion 57 pages. 

-------"----vQ1. 3: sUn, Gang (2-010) Preliminary Analysis ofTribufos Technical Grade 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 Regulatory Associates, Inc. 

Agent for Red Eagle International LLC 

Catherine M. Byrd 

Name 

Signature 

(302) 234-2-'80 

Phone 

143
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

WASHINGTON, D.C. 20460 

August 11, 2010 

REDEAGLE INTERNATIONAL LLC 

7460 LANCASTER PIKE, SUITE 9, PO Box 640 

HOCKESSIN,DE 19707-0640 

Report of Analysis for Compliance -with PR Notice 86-5 

OFFICE OF 

PREVENTION, PESTICIDES AND 

TOXIC SUBSTANCES 

Thank you for your submittal of 09-AUG-l O. Our staff has completed a preliminary 

analysis of the material. The results are provided as follows: 

Your submittal was found to be in full compliance with the standards for submission of 

data contained in PR Notice 86-5. A copy of your bibliography is enclosed, annotated with 

Master Record ID1s (MRIDs) assigned to each document submitted. Please use these numbers in 

all future references to these documents. Thank you for your cooperation. If you have any 

questions concerning this data submission, please raise them with the cognizant Product 

Manager, to whom the data have been released. 

144
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::;-

145
/ 

PRIA 2 - 21 Day Content Screen Review Worksheet 

(EP AlOPP Use Only) 

3/23/09 

21 Day Screen Start Date: .& - 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 package type 

Confidential Statement of Formula 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 Certification with to Citation of Data 8570-34) (Link to 

4 

form) completed and signed (N/A if 100% repack) 

Certificate and data matrix consistent 

If applicant 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 if source is unregistered or applicant owns the 

no 

Yes No N/A* 

Data Matrix (EPA Form 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 of Label (link to 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 

146
7 Is the data p_ackage consistent with PR Notice 86-5 (link to PRN 86-5) >< 

Notice of Filing (link to 

8 htt~:i /www.eQ3.gov/l!esticides/regulatingitolerance l2etitions.htm) included 

with petitions (link to X 

http://www .<jla.JlOv~sticides/re2ulating/tolerances.htm) 

9 If applicable for conventional applications, reduced risk rationale (link to 

http://www.epa.gov/opprdOOllworkplan/reducedrisk.html) X 

Required Data (link to 

httl! ://www .eQa. gOY iQestici des/regulatin g/ data reguirements.htm) and/or 

data waivers. See Footnote C. 

a) List study (or studies) not included with application 

10 

2 

147
Comments: 

~ 

)~ It? 

* N/A - Not Applicable 

Footnotes 

A During the 21 day initial content review, all eSFs will be reviewed to determine 

whether all inerts listed, including fragrances, are approved for the proposed uses. If an 

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 of the inert or 3) 

withdraw the application. Removing or substituting an inert ingredient will require a new 

eSF and may require submission of data. All information, forms, data and 

documentation resolving the inert issue must have been received by the Agency or the 

application withdrawn -within the 21 day period, otherwise, the Agency will reject the 

application as described below. 

To successfully complete this aspect of the 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 

148
site (link to http://www.epa.gov/opprdOOllinerts/lists.html] and if the inert is not 

approved, to obtain the necessary inert approval prior to submitting an application 

to register a pesticide product containing that inert ingredient. Some inert 

ingredients are no longer approved for food uses or certain types of uses. The name 

and/or CAS number on a CSF must match the name and CAS number on this web site. 

Simple typographical errors in the name or CAS number have resulted in processing 

delays. 

If an inert 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 of the 

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 Chief of 

Microbial Pesticides Branch [Link to 

http://www.epa.gov/oppbppdllbiopesticides/contactsbppd.htm] . 

\\Then a brand, trade, or proprietary name of an inert ingredient is listed on a CSF, 

additional information such as an alternate name of the 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 ifit has been approved. Each component of an inert 

mixture (including a fragrance) must be identified, In some cases, the supplier of the 

mixture or fragrance may need to provide this information to the Agency. Prior to the 

Agency's receipt of an application, applicants must arrange with a proprietary mixture or 

fragrance supplier to provide the component information to the Agency or promptly upon 

EPA's request. If the inert ingredients in a proprietary blend (including fragrances) 

cannot or are not identified or provided 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 of an lUlapproved inert, 

Unapproved Inerts Identified on CSFs 

All applications except conventional new products 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 

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. If this 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 

149
3. Withdraw the application (the Agency retains 25% of the full fee for the fee 

category estimated); or 

If none of these options is selected and implemented by the applicant within the 

21 day content review period, the Agency will reject the application and retain 

25% ofthe full fee of the category identified. 

Conventional New Product Applications 

"When the Registration Division identifies an unapproved inert on a CSF with an 

application for a new product that 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 or exemption from a tolerance. (This option may change the PRIA 

category for the 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% of the full fee for the fee 

category estimated); or 

If none of the above options is selected and implemented during the 21-day 

content-review period, the Agency will reject the application and retain 25% of 

the appropriate fee for the new product-inert approval category. 

PIP Applications 

When the 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 of the 

inert to that in 40 CFR 174, or providing documentation that the inert has been 

approved; or 

2. Submit the information and data needed for the Agency to approve the 

unapproved inert. If an inert ingredient tolerance exemption petition is 

required, the petition must be received by the Agency and the B903 fee paid 

within the 21 day period. If this option is selected and implemented, the 

Agency vv:ill discuss harmonizing the timeframe for both actions. 

5 

150
I 

3. Withdraw the application (the Agency retains 25% of the full fee for the fee 

category estimated); or 

Ifnone of the 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 of offers 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 of offers to pay will be placed into either R301 or 

AS31. The Agency recommends that authorizations of offers to pay be submitted with 

other PRIA applications to avoid delays in the 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 of such discussions 

should be submitted with the study waiver. 

6 

151
RedEagle Tribufos Technical Certification Statement 85678-

Catherine Byrd ~o Jennifer Brandon 08/12/201012:31 PM 

Good afternoon Jennifer, 

I have attached a revised Certification Statement form. 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 Lancaster Pike, Suite 9 

Hockessin, Delaware 19707 

P: 302.234.2780 

F; 302.234.7570 

www.wagnerreg.com 

am 

Ce1liflcafion Statemenl EPA Form 8570·34 signed. pdf 

152
) 

UNITED STATES ENVIRONMENTAL PROTECTILiN AGENCY 

WASHINGTON, D.C. 20460 

August 10, 2010 

OPP Decision Number: D-438264 

EPA File Symbol or Registration Number: 85678-RN 

Product Name: TRIBUFOS TECHNICAL 

EPA Receipt Date: 09-Aug-20 1 0 

EPA Company Number: 85678 

Company Name: REDEAGLE INTERNATIONAL LLC 

CHERYL WAGNER 

WAGNER REGULATORY ASSOCIATES,INC. 

REDEAGLE INTERNATIONAL LLC 

7460 LANCASTER PIKE, SUITE 9, PO Box 640 

HOCKESSIN, DE 19707-0640 

OFFlCEQF 

PREVENTION, PESTICIDES AND 

TOXIC SUBSTANCES 

SUBJECT: Receipt of Registration Application Subject to Registration Service Fee 

Dear Registrant: 

The Office of Pesticide Programs has received your application and certification of 

payment. If you submitted data with this application, the results of the PRN-86-5 screen will be 

communicated separately. During the administrative screen, the Office of Pesticide Programs 

has detennined that this Action is subject to a Pesticide Registration Service Fee as defined in 

the Pesticide Registration Improvement Act. 

The Action has been identified as Action Code: R31 0 

NEWPRODUCT;NON-FAST TRACK (INCLUDES REVIEWS OF PRODUCT 

CHEMISTRY;ACUTE TOXIClTY;PUBLlC HEALTH PEST EFFICACy); 

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 

153
IFee for Servicel 

j 

{880047*-

This package includes the following for Division 

@ New Registration oAD 

°Amendment oBPPD 

@RD 

2JStudies? D Fee Waiver? I [KJ if Risk Mgr. Dvolpay % Reduction: 

[ 

Receipt No. s-I 880047 ::====~ EPA File Symbol/Reg. No. I 85678-RN 

Pi n -Pun c 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 

154
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 

155
~ -) 

j -

FEE FOR SERVICE 

156
Online 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 Holder J 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 

Payment Amount: $4,578.00 

Transaction Date 08/06/201 0 

and Time: 15:33 EDT 

, . , 

, 

, . 

. 

.. , , ;, , > 

" ' 

" 

157
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 of this collection of information, 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 ,-..~- •. 

158
~. 

\~ UNITED STATES ENVIRONMENTAL PROTECTION 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 of information is estimated to average 0.25 homs per response for 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 CGmments rega .. ding th:l 

burden estimate or any other aspect of this collection of information, 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 

EPA Fonn 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-- ___ . 

159
----:;;<"""'" ft 

! Sl!ZZ' \",_",l UNITED STATES ENVIRONMENTAL PROTECTION 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 of information is estimated to average 0.25 hours per response for 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 C0mments regarding th" 

burden estimate or any other aspect ofthis collection of information, 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 Wagner Regulatory Associates Inc. 

P.O. Box 640 

Hockessin, DE 19707 

Tribufos Technical 

Force 

Footnotes: 1) Certification of Limits is provided in the Confidential Statement of Formula 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<~_"' 

160
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 

161
August 1,2009 

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 RedEagJe International LLC. and its products to: 

Wagner Regulatory Associates, 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 

Chief Executive Officer 

cc; WRA, Inc. 

, , , 

, 

. , " 

" , 

, , , , " , >, , . , 

" , " , , • ' > , > 

• 

, 

, . ----------~~--~~~~~--~~~~~~~~~~~~---------- ,,~,> Address: 1925 E. Edgewood Drive, Lakeland, Florida 33803 ' 

o , , 0 

,,' , 

162
"m~&" __ ",_"*",,"'-='''''''==WM==_=,,,,_,_,,, ___ m'==---'-""-'"ruw-'--~ 

oo~rn ®[RDaY! REGIStRATtOH'~ ,0 , 

&'56''15''- . ~ O· ., ." .. .... I 

·.·SJATEMENTOF FORMULA ENCLOSED 

PRFORM'a.u 

(MARCH 2006' 

Do Not Write 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 of the "Federal insecticide. 

FunSfolde, and Rodentfclde Act. .. 

USOA·A 

163
Pages 164 -166-* Confidential Statement of Formula may be entitled to 

confidential treatment*