# EPA Registration 70506-18 

# Vol.1

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

OFFICE OF PREVENTION, PESTICIDES AND TOXIC SUBSTANCES


### MAR 2 'i 2005 Rebecca A. Clemmer United Phosphorus Inc 423 River View Plaza Trenton, NJ 08611 Subject: Submission ofStorage Stability and Corrosion Characteristics Study BifenUmn Technical InsecticidelMiticide EPAReg. No.'70506-'18 Your Letter Dated: June 14,2004 Dear

### Ms. Clemmer: The data submitted corresponding to guideline reference 830.6317 (Storage stability) and 830.6320 (CorrOsion Characteristics) are acceptable. The review has been inserted in the file for the subject product. !fyouhave any questions regarding this action, please contactBeWanda Alexander ofmy team at (703) 305-7460.Sincerely, 

### George T. LaRocca**Product~anager(J3)** 

### Insecticide Branch Registration Division (7505C)



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DATE OUT: 17/MAE/200S SUBJECT: PRODUCT CHEMISTRY REVIEW 

### OF TGAI/MP [X] EP [J 

### DP BARCODE No.:D312238 REG. No.:70SQ6-1B 

### PRODUCT NAME: Bifenthrin Technical Insectcide/Miticide COMPANY: united PhosphQrQus IncQrporation

FROM:

TO: PCC:128825; Decision No.:352095 

### Shyam B. Mathur, Team Leader Product Chemistry Technical Review Branch/RD (750SC) BeWanda Alexander/George Larocca, RM 13 Insecticide Branch/RD(750SC) 

### IN'l.'ROJ)UCTION The registrant has submitted 

### the. results of one year storage 

### stability (830.6317) and corrosion characteristics (830.6320) studies for bifenthrin technical.
_ The study results have been submitted under MRID No. 464142-01. The TRB has been asked to 

### review the product chemistry data submitted. 

### SUMMARy OF FINDINgS 1. The subject bifenthrin as the 99.4\. 

### product is Technical active ingredient with Bifenthrin containing product label claim of
2. The studies were performed at JAr Research Foundation, Valvada 

### in India. The studies were conducted in accordance to Good Laboratory Practice Principles as published by GEeD 

### in 1998, No.1, [ENV/MC/CHEM(9B) 17]
. 

### 3. The samples were stored in six commercial containers (Fibre board drum with double HDPE liner) at room temperature under warehouse conditions. One container was opened initially and one container was opened at each sampling intervals i.e., after 3, 6, 9 and 12 months of storage. The remaining containers were drawn after 18 months for final evaluations.



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### DP BARCODE No.:D312238 

### REG. No.:70506-1B 

### PRODUCT NAME: Bifenthrin Technical Inaectcide/Miticide 4. The test sUbstance was evaluated with respect to the following tests: Corrosion characteristics: Perforation, darkening, leaking or rust at the seam, appearance of the container (by visual- shape, crack, color) Storage stability: Appearance, acidity, and AI content. The AI content was determined by HPLC/UV(254 nm). 5. There was no degradation or loss of bifenthrin was observed after 12 months of storage. Before storage (0 day), the AI content was 99.04% w/w. After storage at room temperature for a period of 3, 6, 9 and 12 months, the AI content was 98.99, 98.80, 98.75 and 98.64% 

### w/w respectively. 6. There were no signs of. corrosion characteristics. There were no perforation, leaking, rust, darkening, change in the shape or cracks observed on the**co~tainer** 

### of the bifenthrin technical at zero day as well as after 3, 6, 9 and 12 months. CONCLUSIONS 

### The TRB has reviewed the product chemist·ry data submitted for the Bifenthrin technical and has concluded that: The data submitted for the guideline 830.6317 (one year storage stability) and 830.6320 (corrosion characteristics) satisfy the data requirements of 40CFR§158.190 and are acceptable.



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### DP BARCODE No ••D3l2238 REG. No ••70S06-18 PRODUCT NAME. Bifenthrin Technical Insectcide/Miticide 

### HPLC parameters and Instrument Instrument: HPLC (Shimadzu, LC-I0 AT Pump, SPD-IOA UV-VIS detector with CLASS IDA software)
. 

### Detector: operating at 254 nm Column: ODS, 5 pm, 25 mm x 4.6 mm id Guard column: Alltech, Allguard, CIS, 5 pm, 7.5 x 4.6 mm id Mobile phase: Acetonitrile (80) : water (20) 

### Flow rate: 2.0 ml/min Samples injected: 0.5 mg/ml oryzalin and 0.05% (v/v) dimethlphthalate (IS) in acetonitrile:water (l:l, v.v)
. Volume injected: 20 pL



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# • UP, United Phosphorus, Inc.

423 Riverview Plaut TrentoD. NJ, 08-6I1 (609) 392-3200, 18 (ph,ne) (609) 392.()SOS (fox) •



### ..Mr. George LaRocca (PM 13) 

### DocumentPf?CCIssingDesk Office of Pesticide ProgramS (7504C) 

### 'U.S. 

### Environmental Protections Agency

1921 Jefferson Davis

### Hi8hway Arlington, VA 22202 

### Re: 

### Submission ofSfudy 

# ,.

BifcnthrinTccbnieal (EPARcg. No. 70506-18) Dear Mr. 

### LaRocca: Rebecca A. Clemmer Regulatory AtIalrs Manager

June 9,2004



### Enclosed please find a storage stability and corrosion characteristics study. submitted 

### in**s~pon** ofthe registration ofUPI

### Bifenthrin**Te¢hniea~ 48414201**  

### StOrage Stability and Corrosion Characteristics ofBifenthrin Technical 

### (lnjerim Rcport-12Months). United Phosphol)lS, Tne., Study 4210, 

### May 29,2004. 113 p .



### , )mclosed you will find three copies of the 

### study. This letterwill 

### serve as the transmittal ,document " Pleasecontactme if 

### you have any questions.
Very truly yours,

# ·~a.~ Rebecca-A. Clemmer tcleTmner@ypi·usa,!XWl'



# 5i 

# • •

File: RAC-2004-040 

### )!ifeJl!luinTechnical**Re~tioo** 

### File CC: A. 

### Tilhnan J. PritchBr4 

### • •



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I. 464142-00


## United Phosphorus, l'le.

.4l3 RivervIew Plaza

, TreDtoD, NJ, ,.,(l8611

, (609) 392-8200"18 (phon.)

(609) 392.0808 (fax)



### "Mr. George LaRocca (PM 13)



### I.?ocumentfrocessing Desk" , Office ofPesticide Programs (7504C) 

### U.S. EnWonmcntalProtections Agency 1921 reffetson DayisHighway 

### Arllngion. VA 22202 

### En: Submission ofSludy /



### Bifentbrin Technical (!!PA Eng. No. 70506-18) Rebttta A. Clemmer Regulatory Affairs**MaDnge~**



### Juno 9,2004



### Enclosed**pl~e** 

### find a storage 

### stability and corrosion characteristics study. submitted in 

### support 

### ofthe regiBtration ofuPlBifenlhrin Technical: 46414201 Storage Stability and Corrosion charaCteristics ofBifenthrin Technical (Interim 

### Report-12Months). United Phosphorus. Inc., Study 4210, May29,2004.113p. 

### ).!nclosed you will

### find three copies ofthe 

### study.. 

### TIus letterwill 

### serve as the transmittal ,document;, 

### Please CO,ntAct

### me if 

### you have any 

### questions. • • > • 

### Very trulyyours,

# ~Q.~ Enbecca A. Clemmer 

### Cclcmmer@tmi-uslLcom



# 7

# cc: >-**RAC-2~O** 

### Jlifenthrin.technical Registration 

### File 

### A. Tillman

..J.**~ritchard**



# 8UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D.C. 20460



### UNITED PHOSPHORUS INC 423 RIVERVlEWPLAZA TRENTON, NJ 08611 December I, 2004

Report ofAnalysis for Compliance with PR Notice 86·5 OPPICEOP PREVENTION,PESTICIDES AND TOXIC SUBSTANCES



### Thank

### you for your submittal ofOI-DEC-04. Our 

### staffhas completed a preliminary 

### analysis ofthe material. The results are provided as follows: .' Your 

### submittal was 

### found to 

### be in full compliance with 

### the standards for submission of


# • data contained in PR Notice 86·5. Acopy ofyour bibliography is enclosed. annotated ,vith MasterRecord ID's (MRIDs) assigned to each document submitted. Please use these numbers in all future references to these 

### documents. Thank you for your cooperation. If

### you have any questions concerning this data submission, please raise them 

### with the cognizant Product Manager, 

### to whom the data have been released
.



# 9

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• UNITED 5fATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON. D.C. 20400 Office 

### of Pesticide Programs Registration Division (7606e)


### INSECTICIDE BRANCH 

# Fax Name: Rebecca Clemmer 

### Organization: UPI Fax Number: 

### 609-392-0808 Phone Number: 609-392-8200 From: George T. LaRocca, 

### Product Manager 

### (13) Phone Number: 

### 703/305-6100 .Fax Numb.er: 

### 703/605-1225 Date: August 

### 2. 2004

Subject: 

### Bifenthrin Technical/70606-18

Comments: 

### See attached letter regarding data submittal deficiency. You can fax the omitted page to my attention at 

### 703-605-1225
.

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# 10UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D.C. 20460



### UNITED PHOSPHORUS INC 423 RJVERVIEW PLAZA TRENTON, NJ 08611 June 16,2004



### Report ofAnalysis for Compliance with PR Notice 86-5 OFFICE-Of' PREVENTION, PESTICII)ES A.'1D TOXIC SUBST A,.

...CES



### Thank you for your submittal of 14-JUN-04. Our statfhas completed a preliminary analysis ofthe material, The results are provided as follows:
• We are unable to accept your data submittaffor further processing and review, because of


# • the significant deficiencies noted below. It is being returned to YOll for correction. Ifdeficiencies were found which apply to your overall submission, they 

### are described immediately following this paragraph. lfproblems are found with individua1 studes, they are described below linked to 

### the 

### study identifier found on the enclosed copy ofyourbibliography. Rejecled Study 

### [OIl: • Judging from the pagination ofthe study. page 81 was omitted from the submitted 

### copy.



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• ..uP' United Phosphorus, Inc.

423 RIverviewPlaza Trenton. NJ 08611 (609) 392-3200

### x (8 (pbone) (609) 392-0808 (fhx) Rebecca A. Clemmer RegulatoryAJ'falrs Manager

Mr, 

### George LaRocca 

### (PM 13) DocumentProcessingDesk Office**~fPesticide** 

### Programs (7504C) 

### U.S, Environmental Protections Agency 1921 Jefferson Davis 

### Highway Arlington, VA 22202 

### Re: Submission of

### Study Bifen!hrin Technical (EPAReg. No. 70506-18) Dear

### Mr. LeRooca: June 

### 9, 2004



### Enclosed please find astorage stabilityand corrosion characteristics 

### study, submitted in 

### support of!heregistration ofUPIBifenthrin Technical: Reject (01) Storage Stability and Corrosion Characteristics ofBifcn1hrln Technical (Interim 

### Report-12 Months). United Phosphorus,lne., Study4210, May 29, 2004. 113 p . 

### Enclosed you 

### will fmd three 

### copies ofthe 

### study. This letter will 

### serve as the transmittaJ 

### document. 

### Please contact me if 

### you have any questions.
Very trulyyours,

# ~Q.~ Rebecca A. Clemmer**rc!emmer@uDi~uM!com** 

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# 12

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## cc: RAC-2004-040 Bifenthrin Technical Registration File A. 

### Tillman J. Pritcb&<d

RAC-2004-040 

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• UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D.C. 20«0



### UNITED PHOSPHOPUS INC 

### 423 RIVERVIEW P.j.ZA TRENTON, NJ 08611 

### June 16.2004

Report ofAnalysis for Compliance with PR Notice 86-5 OFFICE Of 1'RF;VEJI,-nON.**PF~'ITlCIDES** ANI) TOXIC SllllSTA,'1CES



### Thank you for your submittal of I**4-JUN~04,** OUf 

### staffhas completed a preliminary analysis ofthe material. The results are provided as follows: We are unable to accept your data submittal for further processing and review, because of the significant deficiencies noted below. It is being returned to you for correction. Ifdeficiencies 

### were found which apply to your overall submission. they are described immediately following this paragraph. Ifproblems are found with individual studes. they are described below linked to the study identifier found on the enclosed copy ofyourbibliography. 

### Rejected Study [01]: 

# * JUdging from the pagination ofthe study. page 81 was omitted from the submitted copy.

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• o up, United Phosphorus, Inc.

423 

### Riverview Plaza TreutOD,NJ 08611 (609) 392-8200 x 18 (phone) (609) 392-0808 (&x) Rebecca A. C1emmer Regulatory Affairs Manager



### Mr. 

### George LaRocca (pM 13) 

### DocumentProcessing Desk OfficeofPesticide 

### Programs (7504C) U.S. Environmental Protections Agency 1921 Jefferson Davis Highway Arlington, VA

### 22202 Re: 

### Submission orSwdy Bifcnthrin Technical (EPA

### Reg. No. 70506-18) !lear

### Mr. LaRocca: June 9, 2004

Enclosed please find astorage 

### stability and corrosion characteristics study, 

### submitted in 

### support 

### of the registration ofUPIBifenthrin Technical: Reject (01) 

### Storage Stability and Corrosion Cbnracteristics ofBifenthrin Technical (Interim 

### Report-12 Monlhs). 

### United Phospbnrus, Inc., Study 4210, May 29, 2004. 113 p .


### Enolosed you will find three 

### copies 

### oftho study. This letterwill 

### serve as the transmittal 

### document Please contact me ifyou 

### have any questions.


### Very tru1y

### yours,

# ~Q.~ RebeecaA. Clenuner rctemmer@upi-usa,COID

RAC-2004-040 

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### Bifenthrin Technical Registration File CC: A. Tillman 

### J. 

### Pritchard

RAC.2004-040 

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### H.,.01-2004 

### oa,aT.. Fr
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### PHOSPHORUS 6011120808 T-82T P.001/002 F-199



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• GI) UfI.. United 

## PhOGphorus,lnc.

Phoar. (609) m.mOO.ext,ll1ioa 18 Fax: (609) 3!Jl.{)808 

### DATE: November S, 2004 TO: Mr. Ge<>rgo LaRo
... 

### FROM: Rebetca A.

# CI."""
.., Regularol)'

### Aftl;

..

### Manager 

## suamcr: Repla
.. menaormlHing.tudypage
MESSAGE: 

### Dear Mr. 

### LaRocca: 

# FAX

A\laClled pl•.,.1Ind

### paS. 81 ofthe 

### study Storage Stability and 

### corrosion 

### Cluuacrorislic, ofBifer :brio Technical (12 Months), lai 

### Reseatth Foundation Stndy 4210, May 19, 2004 

### which you indicated 

### was missing 

### front the 

### Agency's c( 

### .'y
. 

### Please contact me if

### you 

### have any questions.



# 18

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# •

• <U> UP, United Phosphorus, Inc.

423 

### Riverview PlwI TreatoD, NJ 08611 (609) 392-8200 x 18 (phone) (609) 392-0808 (fax) 

### Rebeeca**~** 

### Clemmer Regulatory Affairs Manager



### Mr. George LaRocca (PM 13) 

### Document Processing Desk 

### Office ofPesticidePrograms (7504C) 

### U.S. Environmental Protections Agency 1921 Jefferson Davis Highway Arlington, VA 22202 Re: Submission of

### Study Bifentbrin Technical (EPA Reg. No. 70506·18) 

### Dear Mr. LaRncca: June 9, 2004

Enclosed please find a storage stability

### and corrosion characteristics study. submitted in support ofthe registration ofUPIBifenthrin Technical: Reject (01) 

### Storage Stability and Ccrrosion Chamcterisncs ofBifenthrin Technical (hjterim Report-12 Months). United Phosphorus,lnc., Study 4210, May 29, 2004. 113 p . Enclosed you will find three copies ofthe study. This ietterwiIJ serve as the transmittal 

### document Please contact me if

### you have any questions.

v cry truly yours,

# ~a.~ Rebecca A. Clemmer**rcl!tmmer@upi~u5a!com**

RACo2004.(140 

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• File: RAC-2004-040 

### BifenthrinTechnical Registration File CC: A. Tillman J. Pritchard



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# GI> UP, United Phosphorus, Inc.

423 Riverview Plaza AJIB M. Tllln:wJ 1"mItoa, NJ 08611 T«hnlca1 Dlttdor (609) 392-8200 (pIIoII.) (6O!l) 3?U8G8 (fu)



### Iune 28, 2004

Mr. George 

### LaRocca, PM 13 Office ofPesticide Programs (7504C) U.S. Environmental Protection Agency Room 266A, Crystal Mall 2 19211efferson Davis Highway Arlington, VA 22202 Dear Mr. 

### LaRocca: This letteris to request Gold Seal Letters (3 copies each) for the following products: PRODUCT Tengard MUP Insecticide Tengard SFR One-Shot Insecticide Tengard HG Insecticide Perm-Up 3.2 BC Insecticide Cypermethrin Technical Insecticide Bifenlhrin Technical Insecticide Cypermethrin 2.0 BC Insecticide Up-Cyde 2.5 BC Insecticide Cypennethrin 2.5 EC Bifenlhrin SC Lawn & 

### Greenhouse Insecticide UP-Star SC Lawn and Nursery Insecticide UP-Star Gold Insecticide Please send them to my attention at the above address. Sincerely,

# ~~O,~ Rebecca A. Clemmer 

### Regulatory Manager Phone: 609-392-8200 x 18**~'mllil** rclcmmer@upi-un,({)m 

### EPA REG. NO. 70506·5 70506-6 70506-7 10506-9 70506-10 70506-18 70506-19 70506-20 70506-21 70506-22 70506-23 70506-24



### , ,



# 21

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# ..**\!~.** UNITED STATilS EIIVIRONMENTAL PROTECTION AGENCY WASHINGTON, D.C. 20460 OFFICE"" PR£VEH1'IOIl, I'ESTICIDl!S AND TOXIC SUBSTANCES November 

### I, 2004**I.~e** larocca, Inuctl'clde Branch. Registration DlvlslQfl. Office 

### of**~lcldB** Programs. Office off»reventlon, Pesttddes and Toxic Substances, United States Environmental Protection Agoncy (,EPA,), certify that the pesticide product (s) listed below Is, as of the date of this lotter, a registered product under the Federal Insecticide. Fungicide, and Rodenticide Act (FIFRA), .s amended, and that as such, the product(s) may 

### be sold and marketed in the United States of America as authorlzed- and limited by FIFM. Atrue" and correct copy of the product label approved 

### by EPA Is attached to accompany this letter. Roglstration ofthis product(s) with EPA also denote' that the registrant listed below is responsible-for ensuri,ng full compliariee with all the laws ofthe United States ofAmerica. or governing jurisdiction, regarding the sale, storage 

### andlor disposal of the product(s). Further, the recipient 

### of this letter is an notice that the referenced registration 

### andlor the accompanying label may change subsequent to the date of this letter. EPA assumes no responsibility to notify the recipient of this letter of any change in the status of the registration(s) and/or the product label for the product(s) listed below. EPA has Issued registration numbers for the product(s) listed 

### below to: ,,.

## <.,._", United Phosphorus Inc 

### " 423 Riverview Plaza '

.. Trenton. NJ 08611**~ ~.-** **-"~~** 

# • EPA Registration Number: Name of product: 70506·18 Blfenthrin Technical Insecticide/Miticide



### eorge T. Larocca Product Managor (03; 13) Insecticide Branch Registration Division (7505C)



# 22

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# ..**'~**



# •



# • BIFENTHRIN Technical Insecticide/Miticide FOR FORMULATION USE ONLY AC'nVE INGREDIENT: ; Brfenthrin: [2-methy![1, 1'-blphonyll-3-yl) mothyl 3-(2-ch!oro-3,3,3-trlf1uoro-1-proponyl) -2,2-dlmothylcyclopropanocarboxy!ate*

............................................................99.4% OTHER INGREDIENTS
.................................................................................................Q.6ll, TOTAL

............._...............................................................................,.......................100.0% ·Cls /somers 97% minimum, trans Isomers 3% maximum. 

## KEEP OUT OF REACH OF CHILDREN 

# WARNING FIRST AID Have the pioduct contalnor or label with you when caI!1ng a polson control center or doctor, or going for treatment IfSwallowed 

### • Call a polson control contar or doctor Immedlataly10r treatment advice. 

### • Havo person sip a glass of wator If ablo to swallow. 

### • Do_not Induce vomiting unless told to do 80 by 

### a polson control center or doctor. 

### . • Do not give give anything by mouth to an unconscious person. "Inhaled 

## • Move person to fresh air. • If person Is not breathIng, call 911 or an ambulance, than give artIfIc!al respiration, preferably mouth-ta-mouth, If possible. 

### • Call a polson control center or doctor 10rfurther treatment advice. "on skin 

## • Take off contaminated clothing. or clothing 

### • RInse skin Immediately with plenty 01 water10r 15-20 minutes 

### • Call a polson control contar or doctor for treatment advice. ff In eyes 

### • Hold eye open and rinse alowly and genUy with water for 16-20 mlnlrt&s. Remove contact lenses, If present, after tho orst 5 minutes, then contlnue rlns!ng eye. 

### • Can a polson control center or doctorfor treatment acMco. FOR EMERGENCY MEDICAL ASSISTANCE, CALL TIlE NATIONAL PESllClDE INFORMATlON CENTER 1-800-858-7378 United Phosphorus Inc. 423 RJveNiew Plaza Trenton, NJ -08611 EPA Reg. No. 70506-18 EPA Est. No. 41876· IY- 1 NET CONTENTS :



### . Nor REVIEWED 

### In 

### accordance with 

### PR 

### Notice**82-~** 

## based on dmIt 

## kIbeIIns

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# -;:Z/aC(/ol{ • 

## • ••• • • • • 

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# •

7 PRECAUTIONARY STATEMENTS Hazards to Humans (and Domestic Animals) Warning: May be fatal If swallowed. HannftJl If Inhaled or absorbed through the skin. Prolonged or frequently repealed akin contact may cause allergic reactions h some IndMdua/s. Causes moderato eye Irritation. Avoid breathing dust. Avoid cootact with skin, ayes, or clothing. Remove oontamlnaled clothing and wash before reUS8, Wash thoroughly with soap and water after handing and before eating, drinking, or using tobacco. Environmental Hazards This pesticide Is toxic to fish and aquatic invertebrates. Do not discharge effluent containing this product Into lakes, streams, ponds, estuaries, oceans, or public waters unless In accordancewith the requirements of a National Pollutant Olscharge Eliminations System (NPOES) permit and the pennIWng authortty has been' notified In WrIting prior to discharge. Do not' discharge effluent contalnlng this product 

### to sewer systems without previously notifying tho sewage treatment plant authority. For guidance, contact your State Water Board or Regional Office of tho Environmental Protecl.lon Agency. Physical/ChemIcal Hazards Do not use or stom near heat or open flame• DIRECTIONS FOR USE It Is a vlolatlon of Foderallaw to use this product In a manner !nconslstent with Its labeling. Th!s material requ!res h!rther mixing before use Only tor fonnutatfon Into an tnBOCtlc1delmltlclde for (1) "'e101lowlna uses: _ Terreatrlal FoodIFoed Crops: Sweet Com, Succulent Peas and Baans, Head and Stem 8rass!ca Vegetables, Globe Artlchoko, Cucurblts, Herbs, Bananas Umport only), Legume Vogetablas, Cotton, Field Com (Graln and Silage), Popcorn, Field Com Grown for Seed, Hops, Rapeseed, Cancla, Crambo, Strawberries, Canoborries, Lettuce (head), Pears, Citrus, Tomato, Peppers (baH and non-bel!), Eggplant, Spinach, Tree Nuts, Grapes Terrestrial Non-Food: Tennltk:!de and SOU Contact NonfumlgaUon TroalrnGnt Wood Treatment and Pro!9ctlon OutdOor Insect Control Ornamental plants, ms, shrubs, and vines (woody) Residential Lawns Indoor Insect Control Greenhouse Grown Ornamental Trees, Shrubs, Plants, Flowers NOn-bearing Fruit and Nut Trees
- Non--FoodlFeed Areas: May be used to manufacture end-use products for use as a spot or crack and crevice treatment In non-food areas. S!mI!ar aroas where Insects hide orthrough which Insects may enter can be 

### treated. Examploo of non-food araas Include: garbege rooms, lavatories, floor draIns (to sewers), entries and vestibulGs, offlces, locker rooms, machine rooms, bonar rooms, garages, mop closets, and storsge (aftar cannlng and bottling). FoodIFeed Areas: May

## run be used to manufacture products for use In foodlfeed areas. 00 not usa In food areas of food handling establishments, restaurants, or other areas where food Is commercially prepared or processed. 00 not use In serving areas wh!1e food Is exposed or facl!!ty Is In operation. SelVing areas are areas where prepared food ere selVsd such as dining rooms but excluding areas whore foods may bo prepared or held. In the home"aIi food proce&Stng surfaceS and utensils should be covered during troaIment orthoroughlywashed before use. Expo6&d foods should becoverod orremoved. Examples of food areas are areas for receMng, sloraga/packlng (canning, bottling, wrappIng, boxing), preparing, edible wastes, stomge and enclosed procosslng systems (mills, dairies, edible oDs, syrups). Serving areas (when food Is exposed and facility Is In operation) also would be considered a food area. (2) U

...forwhich US. EPA hasacceptedthe requfred data andlorcitation ofdatathattheformulator has submitted tn support of registration; and (3) U

...for experimental purposes -that are In compllanc:o with U.S. EPA requirements. Fonnulatora u81ng this product are reaponalble for obtainIng U.S. EPA registration for their formulated product which may be labeled for the use patterns 88 found listed on thla label.



# 24-

# I " 

### , 

# .'

....**~**



# •



# •

'. Storage and DIapoaaI 00 not contaminate water, food. or feed by storage and disposal. PESTlCfDE STORAGE Keep out ofmach of children and anlmais. Store In original containers only. Store In acool, dry place and avoid excess heat. Carefully open containers. After partial use, replace [Ids and close tightly. 00 not pul concentrate or dilute material Into food or drink containers. 00 not contamInate other pestlddea, fertilizers, water. food, orfeed by storage or cflSposaI. [n caao of spill, avoid contact, Isolate area. and keep out animals and unprotoctod persons. Confino 

# "'"

.. PESTICIDE DISPOSAL PetUcldo wastes are toxic:. 00 not contaminate walor, food or foed by storage or disposal. Improper dlspooaI of excess peatJcrde. spray mixture, or rinaato Is avIolation fo Federal law. Olspose o[ excess waste orpeatleJdo by use accordIng to label dlroctlons, orcontact your State PesUcIde or Environmental ControlAgency, orthe HazardousWasto roprosentatlve attho nearest EPA Regional0f1lc0forguidance.


# . . CONTAINER DISPOSAL Completely empty liner by shaking and tapping sides and bottom [0 loosen clinging particles. Empty residUe Into appllcatlon equipment. Then dispose of liner In a sanitary landfill or by InclneraUon,< If allowed by Stale and local authorities. II drum Is contamInated and cannot be reused, dIspose o[ [n tho 

### samo manner. ' FOR CHEMICAL EMERGENCY: Sp[[[. leak, tire, 

### exposure. or acc[dent. call CHEMTREC 1-800-424-9300



### - CONDmONS OF SALE AND UMITATION OF WARRANTY AND UABILITY UnIted PhoGphorus, Inc. warrants that at the lime of dGllvery, thIs product wDI conform to its chemical description on the 

### label. that'lt wo[ pass without ob}ectIon [n the trade under tho contract description, that seller

## wm convey tiUe hereto, and that such product will be delivered [reo from any lawful security Interest, nen or encumbrance. This [a the onlywarranty made on this product. UNITED PHOSPHORtJS. INC. EXPRESSLY D[SCLAJMS NoN [MPUEDWARAANTIES OFMERCHAN'TAB[UTY AND FITNESS FOR A PARTlCULAR PURPOSE AND, EXCEPT AS SET FORTH [N iHE ABOVE PARAGRAPH, ANY OTHER EXPRESS OR [MPL[ED WARRANT[ES. BUYER ACKNOWLEDGES THE USE OF ITS OWN [NDEPENDEr'lT SKILL AND EXPERTISE [N THE SELECTION AND USE OF THE PRODUCT AND DOES NOT RELY ON ANY ORAL OR WRITTEN STATEMENTS OR REPRESENTATIONS. EPA Approved. Vt2i.1004



# 25

# •..,**~"QI)** 

# UP, United Phosphorus, 

# Inc.



# •



# .. 4%31Uven1cw Pfu:a ADD M. TIllmaa TlUtoo. NJ 08611 Tuhakal DtrtCtor (609)-_) (609)-(fu)



### June 28. 2004

Mr. 

### Goorge 

### LaRocca, PM 13 Office oCPesticide Programs (7504C) U.S. Environmental Protection Agency Room 266A, Crystal Mall 2 1921 Jefferson Davis Highway Arlington, VA 

### 22202 DearMr. 

### LaRocca: 

# - • This letter is to request Gold Seal**Lette~** 

### (3 copies each) for the following products: 

### PRODUCT Tengard MUP Insecticide Tengard 8FR One-Shot Insecticide Tcngard HG Insecticide Perm-Up 3.2 

### BeInsecticide 

### Cypcnnethrin Technical Insecticide Bifenthrin Technical Insecticide Cypcnnethrin 2.0 EC Insecticide Up-Cyde 2.S 

### EC Insecticide Cypermethrin 2.5 EC Bifenthrin SC Lawn & 

### Greenhouse Insecticide UP-Star 8C Lawn and Nursery Insecticide UP-Star Gold Insecticide Please send them to my attention at the above address. Sincerely.

# 'I3.~O.~ Rebecca A. Clemmer Regulatory Manager Phone: 609-392-8200 x 18 e·mail relmtnv:r@upi.usa.com 

### EPA REG. NO. 70506-5 70506-6 70506-7 

## 10506-9 70506-10 70506-18 70506-19 70506-20 70506-21 70506-22 70506-23 70506-24**~**

# ... .

••• 

# . . >



# 26

# •



# • • • 

# .-'ft"

# ~ UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D.C. 20460 OFFICE Of PREVENTION, PESllCIOES AND TOXIC SUBSTANCES August 30, 2004 I, George Larocca, Insecticide Branch, Registration Division, Office of Pesticide Programs, Office of Prevention, Pesticides and Toxic Substances, United States Environmental Protection Agency ("EPA" certify that the pesticide product (5) listed below is, as of the date of this letter, a registered product under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). as amended,**~nd** that as such, the product(s) may 

### be sold and marketed in the United States of America as authorized and limited by FIFRA. Atrue and correct copy of the product label approved by EPA is attached to accompany this letter. Registration of this product(s) with EPA also denotes that the registrant listed below is responsible for ensuring full compliance with all the laws of the United States of America, or governing jurisdiction, regarding the sale. storage andlor disposal of the product(s). Further, the recipient ofthis letter is on notice that the referenced registration and/or the accompanying label may change subsequent to the date of this letter. EPA assumes no responsibility to notify the recipient of this letter of any change in the status of the registration(s) andlor the product label for the product(s) II,ted below. EPA has issued registration numbers for the product(s) listed below to: UnIted Phosphorus Inc 423 Riverview Plaza Trenton, NJ 08611

EPA Registration Number: Name of 

### Product: 70506·18 Bifenthrin Technicallnsecticide/Mlticide

# ~ Product Manager (03; 13) Insecticide Branch Registration Division (7505C)



# 27

# • • UP, United Phosphorus, Inc.

423 Riverview Plaza Trenton, NJ 08611 (609) 392-8200 x 18 (phone) (609) 392'()B08 (fox) Rebetta A.. Clemmer Regulatory Amain Manager



### Mr. George LaRocca (PM \3) 

### DocumentProcessing Desk (Final Printed Labeling) Office ofPesticide Programs{7504C) 

### U.S. Environmental Protections Agency Ariel Rios Building 1200 Pennsylvania Ave., N.W. Washington, D.C. 20460
Re: 

### Fin.lPrinted Label July 27, 2004

Bifenthrin Technica1 InsectieideIMiticide (EPA Reg. No, 70506-18)


### o.arMr. LaRDcca:
Enclosed for your files please find 

### 5copies affinal printed labeling for the subject product 

### It incorpomtes changes approved 

### by the Agency in January 2004. Because ofthe size and shape of the nctuallabcl. it 

### has been cutto 

### fit onto 8**~** 

### x 11'1 paper. 

### Please contact me 

### ifyou have any questions.
Very truly yours,

Rebecca A. 

### Clemmer 

### rclemJD<ir@upi-usa,CQm 

# .. "

# .. • • 

### •• • 

# • • 

## •••• • • • • 

## ••

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## • • 

# .. • • 

### •



# .. , •



# .. .

• • • •

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# .., 

# ... • 

# .....28 =

# &EPA United States Environmental Prot&cUon Agency

EPARogNo. Product Name

ResubmlSslon In response to Agency lDtterdated ___ _ 

# D "Me Too· Application 

# D Other
- ExplaIn below 

# D Notlflco,'Uon
- Explain**bel~**

No bo submitted Unit Packaging wgl

tbe-stAttments I hive madt on this (orm aDd**.lIattachm~nts** thmtoare true., aeturate aDd tOmplete. knowingly

### r.1H or miJttadillg abtement may**~** poDllbahle by DDt or ImprbonmtDt or RegUJalory Atralrs Managsr

Rebocca A. CkHTmtr Ju!y 2T. 2004 

### • • 274811

Papar OIher(Specify)



# .

# .. • •• (Stamped)



## ., 

# · .,

••• ,

• • 

### • •

### ••• 

### • ••• 

### •••• o 

### • •• 

# 29

# , 

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



## JAN 12 2004
Uniled Phosphorus, Inc. c/o Ms. Elizabeth A. Brown, Ph.D. ChemReg International, LLC 1990 Old Bridge Road, Suite 201 Lake Ridge, VA 22192-2383
Dear Ms. Brown: 

### SUBJECT: Amendment Adding FoodlFeed Uses to Label Bifenthrin TechnicallnsecticidelMiticide 

### EPA Reg. No.: 70506-18 Your Resubmission, Sent by 

### Email on January 9, 2004 OFFICE OF PREVENTION, PESTICIDES AND TOXIC SUBSTANCES



### The labeling referred to above. submitted in connection 

### with registration under the Federal Insecticide, Fungicide, and Rodenticide Act, as amended, is acceptable. A stamped copy ofthe label is enclosed for your records. Please submit two copies ofyour final printed labeling before you release the product for shipment. lfyou have any questions regarding this action, please contact Susan Stanton afmy team 

### at (703) 305-5218.

Enclosure Sincerely yours,

# ~/~f- George T. LnRoeca Product Manager (13) Insecticide Branch 

### Registration Division (7505C)



# 30

### , 

### - 

# - - 

## -- . 

### - - 

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

# · . , 

# . ,
Bifenthrin Technical InsecticldelMltlclde FOR FORMULATION USE ONLY ACTIVE INGREDIENT: 8lfenthrfn: (2-methyl[1, 1 '-blphenyij-3-yij methyl 3-(2:.chlofO-3,3,3-lrinuoro--1-propenyl) -2,2-dlmethylcyciopropanecarboxylalo- ............•.•.•.." •..• ".".••" •.,........"

...............,......."

........ 99.40/0 OTHER INGREDIENTS

....................................................................................................................,....**~** TOTAL
.....................................,",
..............."
...... "
..........................,...............,.",
......,.,...................., 100.00 A, ·Cis isomers 97% minimum, trans Isomers 3% maximum. 

# AOe FTED KEEP OUT OF REACH OF CHILDREN WARNING 

# JAN 12 

## 2004 UnHed Phosphorus Inc. EPA Reg. No. 70506-1 Ucdcr tho FDdcrol bedL--k!o,. 

## FuntL:'..ao. and**ItodenU~tdD** !..ct, 423 Riverview Plaza EPA Est. No. aa alIlOIldad. !¢'1' tho pe.'ltlcl.b 

# • Trenton, NJ 08611

# =B~",,-/d" FIRST AID Have the product container or label wllh you when calling a polson control center or doctor, or going for treatment. Ifswallowed 0 Call a polson control center or doctor Immedletely for treatment advice. 0 Have person sip·a glass ofwater Ifable to swallow. 0 Do not tnduce vomiting unless told to do so by a polson control canter or doctor. 0 Do not nlva nlve anvthlnn bv mouth to en unconscious ""'reon. IfInhaled 0 Move person to fresh air. 0 If pernon Is not breathtng, call 911 or an ambulance, then give artlfidal

0**roSPI~!~,** preferably mouth-ta-mouth, Ifpossible. Call a son control center or doctorfor further treatment advice. 

# I If on skin orclothing 0 Take offcontaminated clothing. 0 Rinse skin Immediatelywith plenty ofwater for 15-20 minutes 

# I 0 Call a noison control center or doctorfor treatment advice. IfIn eyes 0 Hold eye open and rinse slowly and genUy with walerfor 15-20 minutes. 

# I 

# • Remove contact lenses, Ifpresent, afterthe first 5 minutes, then continue rinsing eye. 0 Call a- o01son control center or doctorfor treatment advice. FOR 24·HOUR EMERGENCY MEDICAL ASSISTANCE, CALL THE NATIONAL PESTICIDE INFORMATION CENTER 1-800-858·7378 PRECAUTIONARY STATEMENTS Hazards to Humans (and Domestic Animals) Warning May befatal Ifswallowed. Harmful IfInhaled or absorbed through the skin, Prolonged or frequently repealed skin conlact may cause allergic reactions in some Individuals. Causes moderate eye Irritation. Avoid breathing dust. Avoid contact with skin, eyes, or clothing. Remove contaminated clothing and wash before reuse. Wash thoroughly with soap and waler after handling and before eating, drlnklng, or using tobacco. Environmental Hazards This**pest~a** Is lO,xic to fish and aquatic Invertebrates. Do not discherge effluent containing this product Into lakes; 'streamS, ponds, estuaries, oceans, or public waters unless In accordance with the requirements ofa National Pollutant Discharge Eliminations System (NPOES) permit and the permitting authority has Page 1 

# 31

# •

• ......**~.~.--------~.**

# ---------

been noOOed In writing priorto discharge. Do not discharge effluent containing this product to sewer systems without previously notlfylng the sewage treatment plant authorlty. For guidance, conlact your State Water Board or Regional Offlco ofthe Environmental Protection Agency. 

### Physical/Chemical Hazards 00 not use or store ncar heat or open flame. 

### DIRECTIONS FOR USE II Isaviolation ofFederal law to use this product In a manner /nconaialent wilh Hs labeling. This material requires further mixing before use Only for (onnulaUon Into an InsecUclde/mlUclde for (1) Tho following uses: Terrestrial FoodIFeod Crops: Sweet Com, Succulenl Peas and Beans, Head and Stem Brasslca Vegetables, Globe Artichoke. Cucurblts, Herbs, Bananas (Import only). Legume Vogelables, Cotlon, Field Com (Grain and Silage), Popcorn, Field Com Grown for Seed, Hops" Rapeseed. Canola, Crambe, Strawberries, Caneberrles, Lettuce (head), Peers, Citrus, Tomalo. Peppars (bell and norr-be!!). Eggplant. Spinach. Tree Nuta, Grapea Terresbial Non.food: Termltlclde and Soli Contact Nonfumlgatlon Treatment Wood Treatment and Prolection Outdoor Insect Control Ornamental planls, trees, shrubs. and vines (woody) ResldenUallawns Indoor Insect Control Greenhouse Grown Ornamental Trees, Shrubs, Plants, Rowers Non·bearlng Fruit and NutTrees Non-FoodiFeed Areas: May be used to manufacture end-use products for use as a spot or crack and crovlce treatment In non-food areas. SImilar areas where Insects hide orthrough which Insects may enter can be 

### treated. Examples ofnon-food areas Include: garbage rooms, lavatories. floor draIns (to sewers). entrles and vestibules, offices,locker rooms, machine rooms, boiler rooms, garagos, mop closets, and slorage (after canning and bottDng). FoodJFoed Areaa: May rutl be used to manufaclure products for use In food/feed areas. Do not use in food areas offood handling aslabllshmentu, reslaurants, or other areas where food Is commercially prepared or processed. Do not use In serving areas while food Is exposed or facility Is In operallon. Serving areas are areas where prepared food are served such as dining rooms but excluding areas where foods may be prepared or held. In tho home all food processing surfaces and utensils should be covered during treatmenl orthoroughly washed before uso. Exposed foods should be covered or removed. Examples offood areas are areas for receiving, storageJpacldng (canning, boltllng. wrapping. boxing), preparing, edible wastes. storage and oncloted processIng systems (mills, dairies, edible oils. syrups). Serving areas (when food Is exposed and facility Is In oporaUon) also would be considered a food area. (2) Uses forwhich U.S. EPA has accepted the roqulred data andlor citation ofdata that tho formulator has submitted In supportofregistration; and (3) USGS forexporlmentat purposes thataro In compliance wtth U.S. EPA requirements. Formulators ualng this productaro responsible for obtaining U.S. EPA registration fortheIr formulated productwhich may be labeled for tho use patterns as found listed on this labol.

Page 2 

# 32

# -

Storage and Disposal Do not contaminate water, food, orfeed by storage and disposal. PESTICIDE STORAGE Keep out ofreach ofchlldren and animals. Store In original containers only. Store In a cool, dry place and avoid excess hea\. Carefully open containers. After partial use, replace lids and close lightly. Do not pul concentrate or dilute materlal1nto food ordrink containers. Do not contaminate other pesllcldes, fertilizers, water, food, orfeed by storage or disposal. In case ofsp11l. avoid contact, Isolate area, and keep out animals and unprotected persons. Confine splUs. PESTICIDE DISPOSAL Pesticide wastes are loxlc, Do not contaminate water, food or reed by storage or disposal. Improper disposal ofexcess pesticide, spray mixture, or rlnaBte Is aviolation fo Federal law. Dispose ofexcess waste or pesticide by use according to label directions, orcontact your Slate Pesticide or Environmental Control Agency, or the Hazardous Wasle representatlva at the nearest EPA Regional Office for guidance. CONTAINER DISPOSAL 

# • Complelaly empty llner by shaking end tapping sides and bottom to loosen dlnglng partldes. Emply residue Into appllca\lon equipment Then dispose ofliner In e sanitary landfill or by Incineration, Ifallowed by Stale and local authorltJes, Ifdrum Is contaminated and cannot be reused, dispose of In the same manner,

FOR CHEMICAL EMERGENCY: SpHl, leak, fire, exposure, or accldenl, call CHEMTREC**1~00-424-9300** 

# •

Page 3 

# 33

# •

• CONDITIONS OF SALE AND LIMITATION OF WARRANTY AND LIABILITY United Phosphorus, Inc. warrants that at the time of delivery, this product will conform to its chemical description on the label, that It will pass without objection In the trade under the contract description, that seller will convey title hereto, and that such product will be delivered free from any 

### lawful security Interest, lien or encumbrance. This is the only warranty made on this product UNITED PHOSPHORUS, INC. EXPRESSLY DISCLAIMS ANY IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE AND. EXCEPT AS SET FORTH IN THE ABOVE PARAGRAPH. ANY OTHER EXPRESS OR IMPLIED WARRANTIES. BUYER ACKNOWLEDGES THE USE OF ITS OWN INDEPENDENT SKILL AND EXPERTISE IN THE SELECTION AND USE OF THE PRODUCT AND DOES NOT RELY ON ANY ORAL OR WRITTEN STATEMENTS OR REPRESENTATIONS. EPA Approved. 08/25/2003 Revision (notification): **09/05/2003** Draft Amendment **10/0212003,** revised **01/09/2004**

Page4 

# 34 =.....**w_~** ______________ _

. 

### -



### Susan: Elizabeth Brown <brown@chemreg.com > 01/0912004 12:37 PM To: Susan Slanlon/DClUSEPNUS@EPA cc: "Tillman Ann (E-maIO" <atillman@upl-usa,com> SubJ6(1: UPI Blfenthrin EPA Reg No 70506-18



### In response to your phone call ofJanuary 7, 2004, and on behalfofour client United Phosphorus 

### Inc., attached please find the following revised items for the amendment to

# uprs bifenthrin technical label (amendment originally submitted on 10/6/03): 

### draft 

### labeling draft 

### labeling with additional revisions marked as redline 

### data matrix

- Agency Use data matrix

- Public File Copy 

# e The certification with 

### respect to citation ofdata previously filed for this amendment covers any changes inthe data matrix; anew certification will not be filed unless you let me know otherwise.


# • Thanks very much. Please let me know 

### ifthere is anything else that is needed. Would you please acknowledge safe receipt ofthis email and attachments by 

### reply to 

### this message? 

### Regards, Elizabeth Anne 

### Brown «20040109.Bifenthrin Technical Jabel Amendment Food Uses.doc» «20040109.Bifenthrin Technical label Amendment Food Uses,Redllne,doc» «20040109,data matrlx,blfenthln technical fOOd cropsAgency,doc» «20040109.data matrlx,bifenthln technical food crops - Public,doc» Elizabeth Anno Brown, Ph.D, Director, Sclentlt1c & RegulatoryAffairs ChemReg**Int8~ational** 1990 Old Bridge Roed, Suite 201 Lake Ridge, VA 22192 Phone: 703-492·7905 Fax: 703-492·0668 Emafl: brown@chemreg.com Legal Notice: This electronic mall and Its attachments are Intended solely for the person (s) to whom they are addressed and may contain Information which Is confidential orotherwise protected from disclosure, except for the purpose1hey are Intended to. Dissemination, distribution, or reproduction by anyone other than their intended recipients Is prohibited and may be illegal. Ifyou are not an intended recipient, please immediately Inform the sender and send hlm/her back its attachments and destroy
any copies which may be In your possession, 20040109.Blfenthrin T

..

### :h~i:arl.ber 

### ;Im"ndfnerlt F,lOd Us


# 35**--~-----------c------:----------------~** 

## •

20040109,data m..**"',"~** technical food crops - Agen
20040109.data matrlx.b!fenthln technical food crops - Pub 

# •

•

36-.--,

# ...**~"** F.onn Approved OMB No. 2070-0060

# ~**~ITED** STATES ENVIRONMENTAL

## P~ON AGENCY 401 M Street, S.W. WASHINGTON D.C. 20460 Paperwork Redudion Act Notice: The public reporting burden for this collection ofinfonnation is estimated to average 0.25 hours per response for registration activities and 025 hours perresponse for reregistration and special review activities, including time for reading the instruction and completing the necessary forms. Send comments regarding the burden estimate or any other aspect of this collection ofinfonnation, including suggestions for reducing the burden to: Director, OPPE Infonnation Management Division (2137),

, U.S. Environmental Protection M:encv. 401 M**S~-** S.W.•**Washi~l!ton** DC 20460. Do not send the fonn to this address. DATA MATRIX Date: September 17,2003 EPA Reg No}File Symbol 

# I Page I of4 70506-18 Applicant'sfR.egistr.mt's Name and Address: Product: Bifenthrin Technical InsecticideJMiticide United Phosphorus, Inc. 423 Riverview Plaza Trenton.. NI08611 Ingredient Bifunthnn (PC 12882S) , Guideline Reference Number Guideline Study Name MRIDNumber Submitter Status Note**61~f(830.l550** Chemical identi 45654401 United Phos horus Inc uPl 

### Own 61-2a &30.1620) Startin materials and manufacturin ro<:ess 45654-401 UPI 

### Own 61·2b 830.1670) Fonnation ofim unties 45654401 UPI 

### Own**62~1** 830.1700 Prelimin anal ;s 45654401 UPI 

### Own 62·2 830.1750 Certification oflimits 45654401 UPI Own 62-.1 830.1800 Analytical method 45654401 UPI 

### Own 63-2 830.6302 Color 45654402 UPI 

### Own 63·3 830.6303**P~cal5ta1e** 45654402 UPI 

### Own 63-4 830.6304) 

### Odor 45654402 UPI 

### Own None (830.7050) UVlVisible Absorption CITE ALL FMC Corp Agricultural Products Group pay (FMC); The**S<:ot~** Co (S<:otts); The**::nderson~~wn** Fertilizer Division, loc. Andersons 63·51830.7220**Meltin-~M-int** 45838001 UPI 

### own 63·7 (830.7300) Density 45838001, UPI 

### own 46008501, 46008502 63·8 830.7840 Solubilitv CITE ALL FMC. Scotts Andersons I Day 63·9 830.7950) Vaoornressure CITE ALL FMC. Scotts, Andersons Pay 63·10 830.7370 Dissociation constant CITE ALL FMC. Scotts, Andersons Pay**63~11** 830.7550 Octanollwater--;:;-artition CITE ALL FMC, Scotts, Andersons Pay 

# v 63-12 830.7000 InH 45838001 UPI 

### own 63-13 830.631n**Stabi~** 45654403 UPI 

### own Signature Name and Title Date

### ~tZv..L-**~.,J** Elizabeth Anne Brown. ChemReg International, LLC 9/1712003 Registration Agent -;1

-------------- EPA Form 8570-35 (9-97) Electronic and Paper versions available. Submit only Papcr version. Agency Internal Use Copy

# <5**~ITED** STATES ENVlRONMENTALP.ECTION AGENCY 401 MSlreet,S.W. WASHINGTQN. D.C. 20460 Form Approved OMB No. 2070-0060
PaperworkReduction Ad Noflce:-The 

### public reporting-bUrden forthis collection ofinfonnation is

### estiillated to average 

### 0.25houtS per response for registration activities and 025 hours perresponse for reregistration and special review activities. including time for reading the instruction and completing the necessary forms. Send comments regarding the burden estimate or any other aspect ofthis collection ofinformation. including suggestions for reducing the burden to: Director. OPPE Information Management Division (2137), U.s. Environmental Protection**A~encv.** 401 M Street, S.W•• WashinRton DC 20460. Do not send the form to this address.
Date: September 17, 2003 Applicant'slRegistrant's Name and Address: United Phosphorus, Inc. 423 Riverview Plaza Trenton. NJ 0861 I Ingredient: Bifenthrin (pC 128825)

}.7220 1830.7370



### It. 

### 2!:**71~** 

### IBoiling point**V'** Fis'


# .**I~"'"** D,.JV,I.J.>V Inver

.,,, t:: 850.1400 Fish life**~lyJ** I (850.3020) n . 1(870.1100)

, (870.1200) 1-3 (870.1300) 1-4/ 0 ""- 

## -81-5 81· 81 82- Signature

### ~tZ<.<L**'Xf,..,~** :utei

I\cute I Name DATA MATRIX

MRlD: 45838001, 45838001

...,0.,01\1\1

ITE, ITE, 

### TE, EPA Reg NoJ File Symbol 70506-18 Product Bifenthrin TechnicallnsecticidelMiticide

FMC. Scotts. FM'G, Scotts,**~** FMC. Scotts, kotts•

## IS~ >wn 

# i a Pa Pa 

## !!L !!L Pay

,1:tLn.J...J.. (' 

## :rrE/·1 .., "Scotts•

-**~** UPI

---------- Own 

### rE,**,J~~Us.** i45505 

### UPI Own 

# t00155286 FMC Old ) 132522 FM'"' 1"\1..1 )132521 FM..... VI

.. [)132523 FMC Old :lTE ALL FMC. Scotts. Andersons Pay**~IJ'E** ALL 

### PM.c:::. Scolts, Andmons**~_** Name and Title Elizabeth Anne Brown. ChemReg International. LLC Registration Agenl Page2of4



# I Note

Dote 9/1712003 EPA Form 8570-35 (9-97) Electronic and Paper versions available. Submit only Paper version. Agency Internal Use Copy

### ·**~")**

## ~ .NITEDSTATES ENVIRONMENTAL P.ECI10NAGENCY 401 M S'
.... 4 S.W. Form Approved OMS No. 2070-0060
WASHINGTON D.C. 20460 Paperwork Reduction Act Notice: The public reporting burden fOf this collection ofinformatJon 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 (orms. Send comments regarding the burden estimate or any other aspect ofthis collection ofinfonnation. including suggestions for reducing the burden to: pirector, OPPE Infonnation Management Division (2137). U.S. Environmental Protection**A~ency,** 401 M Street. S.W.**Washin~ton** DC 20460. Do not send the funn to this address. DATAMATRIX Date: September 17.2003 EPA Reg No)File Symbol 

# I Page 3 of4 70506·18 Applicant'slRegistrant's Name and Address: Product: Bifenthrin TechnicallnsecticideIMiticide United Phosphorus., Inc. 423 Riverview Plaza Trenton, NJ 08611 Ingredient: Bifenthrin (PC 128825)
Guideline Reference Number Guideline Study Name MRID NUmber- SUbmitter Status Note 82-2 870.32oo} 21-Dav dermal toxici


# -"'" ClTEALL FMC Scotts. Andersons Pa 82-7 none Subchronic neurotoxici

- rat ClTEALL FMC. Scotts Andersons 83-la 870.4100 Chronic feedin toxici rodent CITE-ALL FMC. Scotts. Andersons P. 83-lb 870.4100) Chronic feeding toxicity- dog_ CITE-ALL FMC Scotts AndeJ50DS Pa 83-2a 870.4200 Oncogenicity- rat CITE-ALL FMC. Scotts. Andersons Pay 83·2b 870.4200 Oncogenicity. mouse CITE-ALL FMC. Scotts.. Andersons Pay 83·3. 870.3700**Teralo~enicitv** - rat CITE·ALL FMC Scotts. AndeJ:SOns Pay 83.3b 870.3700 TeratoRenici rabbit CiTE-ALL FMC, Scotts Andersons Pa 834 2-Generation Reproduction Stud CITE·ALL FMC Pa OPPTS 870.6300 Developmental Neurotoxicity Data gap 84-2 Mutagenicity studies CITE-ALL FMC Scotts, Andersons Pay 844 Other genotoxic effects CITE-ALL FMC Scotts Andersons Pay 85·1 (870.7485) General metabolism CITE-ALL FMC. Scotts. Andersons Pay 85·2**~alabso** tion CITE-ALL FMC Scotts. Andersons Po 161-1 H tol is CITE ALL FMC. Scotts. Andersons P 161-2 Photode alion in water ClTEALL FMC Scott<;, Andcrsons Pay 161-3 Soil photolysis CITE-ALL FMC Pay 162-1 Aerobic soil metabolism CITE-ALL FMC. Scotts, Andersons Pay 163-\ Adsorption/desorption CITE ALL 

### Me. Scotts. Andersons Pay 163-2 Lab volatility CITE ALL FMC Pay 164-1 875.2200 Field soil dissipation CITE-ALL FMC. &otts Andersons Pay r, 165-4 Bioaccumulation in fish CITE-ALL FMC. Scotts. Andersons a S ecial studies 

## 0""" CITE ALL Pyrethroid Workin Group Signature Name and Title Date

# ~""-<.L~ Elizabeth Anne Brown, ChemReg International, LtC 9/1712003 Registration Agent EPA Form 8570-35 (9-97) Electronic and Paper versions available. Submit only Paper version. Agency Internal Use Copy**~**



# -


# .**~"l** _NlTED STATES ENVmONMENTAL

## P~ION AGENCY Fonn Approved OMS No. 2070-0060

## ~ 401 M Street,S.W. WASHINGTON D.C. 20460 PaperworkReduction Act Notice: The public reporting burden for this collection ofinformation is estimated to average 0.25 hours per response for registration activities and 0.25 hours per response for reregistration and specia1 review activities. includingtime for reading the instruction and completing the necessary fo,rms. Send comments regarding the burden estimate or any other aspectof this collection ofinfoonation. including suggestions for reducing the burden to: Director, OPPE Information ManagementDivision (2137), U.S. Environmental Protection ,401 M Street,. S.W. Washington DC 20460. Do not send the fonn to this address. DATA MATRIX Date: September 17.2003 EPA Reg NoJFile Symbol 

# I Page 4 of4 70506-18 Applicant'slRegistrant's Name and Address: Product: Bifenthrin Technical InsecticidelMiticide United Phosphorus, Inc. 423 Riverview Plaza Trenton, NJ 08611 Ingredient: Bifenthrin (PC 12&825)
Guideline Reference Number Guideline StudyName MRIDNumber Submitter Status Note \32-1 (857.2100) Foliar residue dissipation CITE ALL FMC, Scotts Andersons Pa 133-3 (875.2400. 2500) Dermal exposure ClTEALL UPI is a member oftile Ag Re.entry task Own forte; UPI is a member of the Outdoor 

# . Residential Task Force 1334 (857.2500) Inhalation exposure CITE ALL UPl is a member ofthe Ag Re-entry task Own



### , force; UPI is a member ofthe Outdoor Residential TaskForce 201-1,**202~1** (840.1100, Spray drift and dropletsize CITE ALL UPI is a member ofthe Spray Drift Task Own 835.4200) Fo= 171-4a Nature ofresidue

- plants ClTEALL FMC Pay 171-4b Nature ofresidue livestock ClTEALL FMC Pay 171-4e Residue analytical method

- olants ClTEALL FMC Pay 171-4d Residue anal 'caI method animals CITE ALL FMC Pay 171-4e Residue storage stability CITE ALL FMC pay 171-4" Magnitude ofresidues meatimilklpoultry/egg ClTEALL FMC Pa 171-4k Magnitude ofresidues field crop trials ClTEALL FMC.IR4 Pay 17141 Magnitude ofresidues

- processed commodities CITE ALL FMC Pay 171-4m Multi-residue method CITE ALL FMC Pay 165-1 Confined rotational em CITE ALL FMC Pay 165-2 Field rotational ero CITE ALL FMC Pay .j:>. 

# o Signature Name and Title Date

### ~~~ Elizabeth Anne Brown, ChemReg International, LLC 911712003 Registration Agent EPA Form**8570~35** (9-97) Electronic and Paper versions available. Submit only Papervcrsion. Agency Internal Usc Copy

----- 

# , i i**.. IT**  **...**

### J

hours perresponse for reregistration burden estimate or

Phosphorus, £nc. 423 Riverview Plaza

Signature

..

## ~~~ eNITEDSTATES

## ENVI!~~'.!E'rr.A"L.~.CTION AGENCY
perresponse review activities. including time for reading the instruction and completing the necessary forms. Send comments regarding the ofinformation. including suggestions for reducing the burden to: Director, OPPE Infonnation Management Division (2137),

- the form to this address.

v

Name and Title Co (Scotts); The Fertilizer Division, Inc. P'Y

own

Elizabeth Anne Brown, ChemReg International. LLC Registration Agent D,te 11412004 EPA Fonn 8570·35 (9·97) EleclTonic and Paper versions available. Submil only Paper version. Public File Copy**~J**

hours pet'response forreregistration and special burden estimate orany other

Date: Januarv 9. 2004

. Inc. 423 Riverview Plaza Trenton. NJ ( Ingredient; E

Signature

## ~tZu.L~ .NITEDSTATES ENVIRONMENTAL P.CTIONAGENCY' 401 M Street. S.W.
time per instruction and necessary forms. Send comments regarding the Director, OPPE Information ManagementDivision (2137),

Name and·Title Dote Elizabeth Anne Brown, ChemReg International, LLC 1/412004 Registration Agent EPA Form**8570~35 (9~97)**  Electronic and Paperversions available. Submit only Paper version. Public File Copy**~**

# ~ .NITEDSTATES ENVIRONMENTALP.CTION AGENCY 401 M Street, S.W. WASHINGTON. D.C. 204<>0 Fonn Approved OMS No. 2070-0060
Paperwork Reduction Act Noti«: The public reporting burden fOr this collection ofinfonnation is estimated to average 0.25 hours perresponse for registration activities and 0.25 hours per response for reregistration and special review activities, including lime for reading the instruction and completing the necessary forms. Send comments regarding the bW'den estimate or any other aspect ofthis collection ofinformation, ineluding suggestions for redUCing the burden to: Director, OPPE Information Management Division (2137), U.S. Environmental Protection**~ncy,** 401 M Street, S.W .• WashingtOn DC 20460. Do not send the fonn to this address.
Date: January 9, 2004 Applicant's1Registrant's Name and Address: United Phosphorus, Inc. 423 Riverview Plaza Trenton. NJ 08611 Ingredient: Bifentfuio (PC 12882S)

Signature

### ~Jtz..-u..~ DATA MATRIX

EPA Fonn 8570·35 (9·97) Electronic and Paper versions available. Submit only Paper version. EPA Reg NoJ File Symbol 70506-18 Product: Bifenlhrin Technical InsecticideIMitit:ide

Name and Title Elizabeth Anne Brown, ChemReg Inlemational, LtC Registration Agent Page 3 of4

Date 1/412004 Public File Copy

# -**~** eNITED STATES ENVIRONMENTAL

### P~ION AGENCY 401 M Street, S.W. WASHINGTON,D.C. 204<i0 Form Approved OMB No. 2070...(){)60
PapenvorkRedudion Aet Noli«: The public reporting burden for this collection ofinfonnation is estimated roaverage 0.25 hours per response for registration activities and 025 ft.ouss per response for reregistration and special review activities, including time for reading the instruction and completing the necessary fonns. Send comments regarding the burden estimate orany other aspect ofthis collection ofinfonnation. ineluding suggestions for reducing the burden to: Director. OPPE Information Management Division (2137), U.S. EnvironmentaJ Protection A2Cf\CY, 401 M Street. S.W.• Washington DC 20460. Do not send the form to this address. Date: January 9, 2004 Applicant's/Registrant's Name and Address: United Phosphorus, Inc. 423 Riverview Plaza Trenton. NJ 08611 Ingredient: Bifenthrin (PC 128825)

.j::>. .j::>.Signature

### ~~~ DATA MATRIX

EPA Form**8570~35 (9~97)**  Electronic and Papervcrsions available. Submit only Paper version. EPA Reg No)File Symbol 7050<H8 Product: Bifenthrin Technical InseeticideIMiticide

Own

Name and Title Elizabeth Anne Brown, ChemReg International, LLC Registration Agent Page 4 of4

Date 1/412004 Public File Copy

# , 

# ,



# •

• ACTJVE INGREDIENT: 

## Blfenthrin Technical InsectlcldeIMltlcide FOR FORMULATION USE ONLY
Blfenlhrln: {2-mothyl[1 t**1'-b[phenyq..a..y~** me[hyl 3-(2.-chI0r0-3,3,3-trilluoro-1**~propenyl}** ",,- -2,2-dlmethylcyclopropanecal'boxylato·••••••..,••••"..•.••,•••, •.••.••..••••••,•••••••••••••,.,•••••••••••••••.•.••.•.**9~.~~** /' OTHER INGREDIENTS
..""."" ••.•••.•"."""•••.""." ••"."•.••"••"."..••••....,,.".""
.............................."•••,,""

# !l.li:li!'v'" TOTAL ••:•••••••••.••••...•••••.•..••.•••.•.•.••••••.••....••••••...•••••.•..••..•.•••.••.••.•.•........•••••.,•••..••••.••••••,•••:•••••••••••••••. 100.WA. ·C[s [somers 9r% minimum,

### tmri~ Isomers 3% maximum/' 

## KEEP OUT OF REACH OF CHILDREN WARNING United PhosphOrus Inc. / 423 RiVerview Plaza Trenton. NJ 08611 EPA Reg. No. 7050§it8 EPA Est. No. .,/



### . FIRST AID**I~** Have the product container or label with you when calling a polson control cenler or doctor, orgoIng for treatment. 11 'Swallowed 

### • Call a polson control conter or doctor [mmadlately for treatment advlce./ 

### • Have person sip a glass ofwater II able to swallow. 

### • Do oot Induce vomiting unless told to do so by a polson controt center or doctor. 

## • Do not a[ve aive anvlh[nn b mouth to an unconscious person. 

# '" [f Inha[ed 

### • Move person to fresh air.**rt~** 

### • Ifperson Is nQt breathing, call 911 or an ambulance, then give ertlfi '/ respiration, preferably mouth·to·mouth, If possible. 

## • Call a nolson control center or doctorfor furthertreatment advice. If on skln orc[othlng 

### • Take offcontaminated clothing: 

## /" • R[nse skin Immediatelywith plenty ot water for 15-20 minutes 

### • Call a ootson control center or doctorfor treatment advlco. [f in eyes 

## • Hold eye open and rinse slowly and gentlywith water for**15-~~tes.** Remove contact lenses, If presen1, alter the first 5 minutes, the ntinue rtns[ng eye. 

### • CaI[ a-oo[son control centeror.doctorfor treatment advice. / FOR 24-HOUR EMERGENCY MEDICAL ASSISTANCE, CALL THE NATIONAL P71CIDE INFORMATION CENTER 1-800-8513-7378 

### PRECAUTIONARY STATEMENTS Hazards to Humans (and Domestic Animals) Warning May be fatal Ifswallowed. Harmful If Inhaled orebsorbed through the skln. Causes modemte eye [rrltation. Avoid breathing dust. Avoid contact with skin. ayes, or cloth[ng. Remove contaminated clothing and wash**,~,..u**

# '. before reuse. Wash**~ghly** with soap and water.af!er**~and[[ng** "d before eating, drlnklng, or using 

# .r- tobacco. 

### /Idol**~rM.** 

## St"s

.**.:!!'~""~** 

### Environmental Hazards This pesticide [s toxic to fish and aquatlc Invertebrates. Do not discharge affluent contalnlng this prodUY Into lakes, streams, ponds, estuaries, oceans, or public waters unless In accordance with 1he requlreme ofa Natlonal Pollutant Discharge Ellmlnatlons System (NPDES) perml! and 1he permitting authority has boen notified In writing prlor10 discharge. Do not discharge effluent containing 1his product to sewel 

### Page 1 

# 45"



# •

• syslems withoutpreviously notIfyIng the sewage treatmanl plant authority. Forguidance. corrtact your state/" Water Board or AeglonaJOffICe oftho Environmental Protection Agency. 

### Physical/Chemical Hazards ./' Do not use or stofe near heat or open flame. 

### DIRECTIONS FOR USE ,/' It Is a violation of Fedemllaw to use this product In a manner inconsistent wllh Its labeling. This malarial requires further mixing before use

### ~ Into an InaectlcldeimlUcldo for

TOf1'H.trial Non..food: ./ TermHlcldo and Soli Contact Nonlumlgatlon Treatmenr'" Wood Treatment and**Pro~v** Outdoor Insect Control ,- Omamental plants. 

### trees, shrubs, and vines {woody} ResidenUal Lawns ,/' Indoor Insect Controf/ Non·Food/Feed Areas: May be us.ed 10 manufaclura end-use products lor usa as aspol or crack and crevice treatment In non...food areas. Similar areas where Insects hlcio or through which Insects may ant0V--- can be treated. Example& of non·food areas Include: garbage rooms. lavatories, floor drains (to sewers), entries and vestibules, offices, locker rooms, machine rooms, boiler rooms, garages, mop closets. and storage (aftercanning and bottling). FoodIFeed Areas: May

### mt be used to manufacture products for use In loodIfaed ereas. 00 not use In lood areas offood handling establishments. restaurants. orother areas wIlore food Is commercially prepared or processed. 00 not use In serving areas while food Is exposed or laclllty Is In operaUon. Serving areas are**~** areas where prepared food are served such as dining rooms but excluding areas where loods may be ....-- prepared or held. In lhe home all 1000 processing surfaces and ulansBs should be covered during treatmenv or thoroughly washed before usa. Exposed loods should be covered or removed. Examples of lood sn'las are OrGaS for roceMng, store{1Olpacidng (canning, bottling. wrapping, boxing), preparing, edible wastes. storage and enclosed processing systems (mills. dairies. edible Oils. syrups). Serving areas (when food Is exposed and facility Is In operation) also would be considered a food area. (2) UIHforwhich U.S. EPA has accepted tha required data and/or citation of data that**~** formulator has submitted In supportoftegIBtraUon;·and (3) Usee for experfmental purposes thatare In compllanC<! with U,S. EPA requirements.

# ~ Fonnulators usIng this productare reeponslble for obtalnlng U.S. EPA registration fortheir / formulated productwhIch may be labeled forthe use pattoma 8$found listed on this label.

Page 2 

# 46

# I < 

### storage and DIsposal 

# ./ Do not contaminate water, food, orfeed by storage and disposal. PESTICIDE STORAGE 

# V Keep out of reach of children and animals. Siore In original containers only. Store In a cool, dry place**a~rv** avold excess heat**C~refuny** open containers. After partial use, replace lids and close tightly. Do not put concentrate or dilute material Into food 

## or drink containers. Do not contaminate other pestieldes, fertilizers,



### __m___

# w__**~** In case of spl!!. avoid contact, Isolate area, and.keep out animals and unproJected persons. Connne sis. PESTICIDE DISPOSAL Pesticide wastes are toxic. 00 notcontaminate water, food orfeed by storage or disposal.**'lmprope~** disposal of excess pesticide, spray mixture. or rlnaals Is a vlolatten to Federal law. Dispose of excess waste or pesticide by. use according to label direcUons, or contact yourState Pesticide or Envlronrn a! Control Agency, or the Hazardous Waste representative at the nearest EPA r;l:eglonat Office forguidance, 

## • CONTAINER DISPOSAL

### ~ Completely empty Hnar by shaking and tapping sides and bottom to loosen clinging particles. Emp residue Inlo application equipment. Then dispose of liner In a sanitary landfl!! orby Inclnemllon, If a owed 

# • by State and local authorities. If drum Is contaminated and cannot ba reused, dispose of In the same mannar. / 

### I FOR CHEMICAL EMERGENCY: Spill,

## le~ fire, exposure. or accldent./all CHEMTREC 1-800-424-9300 

# •

Page 3 

# 47**------------------------~**.....

# • CONDmONS OF SALE AND UMITATION OF WARRANTY AND UABILITY United Phosphorus, Inc. warrants that at the time of deflvery, this product will conform to Its chemical description on the label•. that It will pass without objection In the trade under the contract description. that seller will convoy title hereto, and that such product will be delivered free from any lawful security Interest. lien orencumbrance. This 

### Is the only warranty made on this product. UNITED PHOSPHORUS. INC. EXPRESSLY DISCLAIMS ANY IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE AND, EXCEPT AS SET FORTH IN THE ABOVE PARAGRAPH, ANY OTHER EXPRESS OR IMPLIED WARRANTIES. BUYER ACKNOWLEDGES THE USE OF ITS OWN INDEPENDENT SKIll. AND EXPERTISE IN THE SELECTION AND USE OF THE PRODUCT AND DOES NOT RELY ON ANY ORAL OR WRmEN STATEMENTS OR REPRESENTATIONS.

Page4 EPA Approved. 08125/2003 Revision (notification): 09105/2003 Omft Amendment: 10102/2003



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October 6, 2003 p,..", 01"" popo, Other (SpecIlY)I __ _**C'Y>'l'~"')** 

### • 

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.... UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

# \~ 401 M STFJEET, S.W. WASHINGTON, D.C. 20460 Paperwork Reduction Act Notice: Tho public roporlIng bufdenJor this collection ollnformatJon Is estimated to average t.25 hours por response for registration and 0.25 hours per response for reregistration and spec!nl reviow actlvlUsa,lncluding tlmo for reading the Instructions and completing Ihe necessary fo!1l1S. Send comments regard1ng burden esllmalO or any othoraspect 01 thl$ collection of Information, Including suggestions for reducing the burden to: Director, OPPE Information Management Division (2t37). U.S. Envlronrmm!al Projection Agency, 40t M Stroot, S.W., Washlnglon, DC 20460. 

# 0'
.....
• Uoited 1 ' Nama, Address, and Telephone Number EPA Registration Numbcr/Filo Symbol 70506-18

.**~~ ,~"~B611**  

### . andlor representativo lest compound(s) 

### lOst.**tall~~~~~~~~!** 40 CFR Part 158) I

## ~:OO""N!",,~ 1 

## ")'0"' 1 '00% 1**~roducf** labeled lor all the same U58S on your lobel, you do nol need 

# D I am responding 10 a Data·Call·ln Nollen, and have Included with this form a list of companies sont offers of compensDllon (the Data Matrix fonn should be used forthlB purpoae). 

## "0.' 

# D I am using tho cite-aIl method of support, and have Included I'tith

## ~ 1run 1 t i'" 1 this fOfTJl a Ost of companlessllt\l offers of compensation (the Data 1 Matrix form should bo used forthls purpose) Matrix form <fl' 'TO PAY (Required If using the cIt"1I method, or when using the clte-all option under Ihe seleCtIve method 10 sellsfy one or more data requirements) 

## [Xl I hereby offerand agree to pay compensatlon,!O other persons, with regaijf 10 the epproval 01 this appncallon, to tha extent required by AFRA

, III,



# - 1 or this Data-Call-In response Is supported by all data. submllted or ciled In


# ,''".'''" 

# .•,'' ' II I response. In addillon, Iftho ello-all optlon orelle-all option underthe

, 'Is I by all data In the Agency's flies that (t)concem the properties or eflects of this 1 

# ,-

# ....**~ ~**  or**~nore** 01 tho Ingredients In \hIs product; and (2) Is a typo 01 data that would bo required 10 approval of this application 

### n tha appIlCtl!lon sought the Initial registration of II product of I certify thai for each exclusive use study Clled In support 01 this roglslmtion or roreglDtration, thai Iam the original data eubmltteror that I have obtained the written permission 01 the original data submlllcd to clle that sludy. 1 certify thai for each sludy cited In eupport ofthis rogistraHon or reregistration that Is nol an exclusive use Sludy, either: (a) I am tho OlIglnai data submitter, (b) I have obtained the pemllsslon 01 the original data submltler 10 use tho studyln support of this application; (e) 1111 periods of eligibility for compenaation have expired forlhe study; (d) the study Is In the public IIleralure: or(e) 1 have notified In writing tho cornpanythal submitted tho study and have offered (I) to pay compensation 10 the extent required by secUons 3{c)(t)(F) and/or 3(c)(2)(B) of AFRA; and (II) to commanca negotiations to delennino the amounl and tenns of compensation, 11 any, 10 be paid for the use of the sludy. I certify thai In a111ns!anCes where an offerof compensation Is required, copies of all offers to pay compensallon and evidence of theirdelivery In accoroanco with secllons 3{c)(1 )(F) and/or 3(c)(2)(8) 01 AFRAaro available and Will besubmitted 10 the Agency upon requesl. Should Ilnl! to produce such evidence to the Agency upon request, I understand thatthe Agency meylnlilole action 10 deny, cancel or suspend tho reglslrallon 01 my product In confonnlty with AFRA. I t*rtlfythattha statomonta I have made on this form and all attachments to Itere Irue, accurate, and complete. I acknowledge that any knowJnglyfalse or mll1laadlng statomont may be punl.hOble by fino or Imprisonment 01 both undor applicable law. 

# I**~e6,2003** 

# T_"II**,~** 

## ""'

# tL1~**~o.'** 

## ,I0""""



# . "r 

# 57

# •

• • io. UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D.C. 20460



### Ootober 10, 2003 OFFlCEOF PREVENTION. P£STieJDES ....ND TOXlC SUBSTANCES 

### ELIZABETH ANNE BROWN UNITED PHOSPHORUS INC 423 RNERVIEW PLAZA 

### TRENTON, NJ 08611


### PRODUCT NAME: BIFIlNTHRIN TECHNICAL INSECTICIDEIMITICIDE COMPANY NAME: UNITED PHOSPHORUS INC EPA FILE SYMBOL: 70506·18 

### EPA RECEIPT DATE: 10/06/03 

### SUBJECT: RECEIPT OF AMENDMENT DEAR REGISTRANT:.
"The 

### Office ofPesticide 

### Programs has receiv'ed your application for an amendment and it has passed an administrative screen for completeness. During 

### the initial screen we determined that Ute application appears to qualifY for fast track review. The package will now be forwarded to the Product Manager for review to determine its acceptabilitY 

### for fast 

### track status. . Ifyou 

### have any questions, please contact Registration Division, Risk Management Team 3, at (703) 305·6788. 

### Sincerely,



### FrontEnd Processing Staff Infonnation Services Branch 

### Infonnation Resources and Services Division



# 58

## {:

....**~l**

## ~ :11 bouts pet response for reregistration and special review

_ burden estimate or any other aspect ofthis collection ofi

II;: Pn";.....""""".,,! p...,."......O,v> A",,".voy.401 

## IDale: r 17,2003 

# I,

'1',,"--"- ._giSlrant's Name United Phosphorus, Inc, 423 Rh-erview Plv.8

I-I (8 ill • (PC



# ----- ----- 

### -,-\ :30.1670) '0.1700)


### ,1

63,5 (830.7220) 63-7 (830.7300) 

# _1

**J./')/U)** "- J.7550) " 0.7000) 

### 7 

## I ',1_. ,d.i•.**~** - ••- Ie Siudy Name

Prelimi anal sis Certification oflimits


# . __

# ...........,.....".

EPA ,5**(9~97)** E1ccm;mlc and Paper J. ,(., 

## ammoSTATES ENVIRONMENTAL PRlllllECTiON AGENCY

.. 491 M Street. S.W• ., H".20460 DUI to a\'el8gC 0.25 hours per response for registration activities and 0.25 and**~ompIeting** the necessary foems. Send comments regarding the ing suggestions for reducing: the burden 10: Direclor. OPPE Information Management Division (2137). n DC 20460. Do not send the form to this address. ATRIX**~** •• _ .....&NoiHie ,\<.M_HI

MRlDNumber Submilter 456S44OI United Phosphorus Inc UP!)**,-~-.** 

### ---

......"................. 45654402 CITE ALL FMC Corp Agricultural Products Group (FMC);The Scotts Co (Scotts); The Andersons Lawn Fertilizer Division.lnc. (An( 45838001 UPI 45838001. UPI 46008501. 46008502 f"ITP Al J 

# IFMC. Scous. Andersons

_FMC. Scotts, Ande:rons _________ -ClTEALL FM:C. Scotts. Andcrsons 45838001 UPI 45654403 

### upr Name and Title SItlIUS Ow. Ow. )wo 

### 5Wil )wn Own Own

. Own 

### I pay

own ow. 

# Ire -Pay Pay ow. own
Elizabeth Anne Brown, ChcmReg Imcrnational. LtC ion Agcnl 

# I Page lor4

Note 

# I

Date 9/17n.OO3 

# -

Iy Paper version. Agency Internal Use Copy 

### •

## "A""

# ~ Fonn Approved OMB No. 207()..006{) -..ITEDS1:ATES ENVIRONMENTAL**P~ON** AGENCY 

### '111'" 401**MStree~** S.W:"'III'--- WASHINGTON,D.C.**~** Paperwork. Reductioa Act Notfce: Thepublie reporting bwden for this collection ofinfonnation is estimated**toi-,"~·o.2S**

### boUts perresponse for registration activities and 0.25 hours perresponse for reregistration and special review activities, including time: for reading the"instruction and completing the necessary fonns. Send comments regarding the burden estimate or any other aspect ofthis collection ofinformation. including suggestions for reducing the·burden to: Director. OPPE information Management Division (2137), U.S. Environmental Protection**A~ency.** 401 MStreet. S.W•• Washington DC 20460. Do not send the fOfDlIO this address.
Date: September 17,2003 Applicant'WRegiSifaol's Name and Address: United Phosphorus, Inc. 423 Riverview Plaza Trenton. NJ 08611 Ingredient: Bifenthrin (PC 128825)

I
- (850.2200) ./ (850.2300) 

### v .-' (850.1075) ,/ :-2 (850.1010) ,/ '_':!.{l'l:'iO.lm'i
__ .



# ..-**~** L!.Q Iv -::::'



### v 

## v '"-4

### ~(8!!'70c;"2"'400"')L 5 (870.2500) 6 (870.2600) ,/ 

### rfil-8 (870.6200) ,/ 02.1 (870.3100) 

# v SignalUfC yName

.............2ooint 

# I DiS AVIan;

:ate chronic toxicity 

# +.Fish life early life cycle bee acute conr.acttnxicity Acute oral- rat 

# .lAcute denrutl:- rabbit/rat
rydennal irritation

- rabbit Dermal sensitization 

# +.Acute neurotnxicitv

### ~t1....u-~ DATAMATRlX



## IMRJDI EPA Reg NoJFile Symbol 705Q6.I8 Product: Bifenthrin TechnicallnsecticidelMitieide

StatuS

-T

........."...... UPI Own 

# I Page 2 of4



# i NOte
45838001 UPI Own 

## I I 45838001 ·UPI
. Own 45838001 UPI Own 4583&001 UPI own CITEALL
.FMC. Scotts. Andetrons Pav

Pay FMC. Scans. Andersons Pay FMC. Scotts. Andersons Pay CITE ALL FMC. Scotts. Andersons Pay CITEALL FMC, Scotts. Andcrsons Pa, CrrEALL FMC. Scotts, Andersons pay 45654404 UPI Own 45645505 UPl Own 00155286 FMC Old 00132522 FMC Old 00132521 FMC Old 00132523 FMC Old C/TEALL FMC. Scoltll. Andersoos Pav

/TEALL FMC Name and Title 

# I Date Elizabeth Anne Brown. ChcmReg International, LLC 9/1712003 Registration Agent EPA Form 8570·35 (9·97) Elcclrollic and Paper versions available. Submil only Paper ,"ocrsion. Agency Internal Use Copy 

### c."**-"---"~--**

# ~" .ITEDSTATES

### ENVIRONMENTALP~ON AGENCY**401MSI"'~S.W.** WASHlNGTON. D.C. 20460 FonnApproved OMS No. 207Q..OO6O
Paperwork Reduction Act Notice; The public reporting 

### buIdeo-COr this collection of

### infortruiiionis estimated 10 average 0.25 hours per re.'ipOOSC for registration activities and 0.25 hours per response for reregistration and special review activities. including time for reading the instruction and completing lbe necessary forms•. Send comments regilrding!.he burden estimate or'any other a<;pecl oflitis collection ofinformatioo. including suggestions for reducing the burden 10: Director.OPPE Infonnalion Management Division (2137). U.S. Environmental Protection A2cncy. 401 M Street. S.W.• Washington DC 20460. Do not send the form 10 this address.
Dme: September 17. 2003 Applicant'siRegistrant's Name 

### and Address: United Phosphorus. Inc. 423 Riverview PIa7,a Trenlon. NJ 08611 Ingredient Bifcnthrin (PC 128825)

te StudyName 

### v;
l!::: I) V 

### l!::: 83-3b (870.3700) v

### V 

## ,v' 1-4 ..; 85-1 (870'7485) 

### v' 85-2 v' 161-1 

### v 1t:1_2-,.;
"0) 

### v 1654 

## v Special stUdies 

## v 132-1 (857.2100l'C. 

## m --l.

Signature 121-Dalde Subcbronil Chrom'**~** 

## ." a;-' Oncv/oicllu,;nr

- r.tl

### ~ 

## H':

Field soil Bioaccum 

### <5ihc'f - mouse

_y studies

n in fIsh

## ~4u-~ DATA MATRIX

TB

### :ITETIl 

### :m TIE-, :ITE-, BPA Reg NolFile Symbol 70506-18 Product: Bifenthrin TecbnicallnsccticidetM:iticide

:lTE-tu...J... 

## I r



# ......**~-**

:lTEAJ 

### :lTE-, :ITEJ :. Seous. 

## IFMC. Scotts. j

'YrethroidWe 

### 'Me. Scotts•.

Name and Title 

### l!"l'

Elizabeth Anne Brown. ChemReg Jnlcmational. LLC Registration Agent P:age 3 of4

Dale 9117/2003 EPA Fonn 8570-35 (9-97) EleclIOruc and Paper versions available. S'ubmit only Paper version. Agency Internal Use Copy**~--------------------------------------"** J:.:<

## -

# ~ Form Appro\'Cd OMB No. 2070-0060 8"ITEDSTATES ENVIRONMENTAL PRrONAGENCY 401 MS
.......S.W. WASHINGTON. D.C. 20460 

# . Paperwork. Reduction Act Notice: The public reponing burden Cot' this collection o(jnformation is estimated toaverage 0.25 hours per response for registmdon activities and 0.25 hours perresponse for reregistration and special review activities. including time for reading the instruction and completing the necessary (onns. Send comments regarding the 

# . burden estimate orany other aspect oHhiscollection ofinfonnation. including suggestions-forreducing the burden to: Director, OWE Infonnalkm Management Division (2137), ( U.S. Environmental Pro!eclion**A~y.401** M Street. S.W•• WasbinRton DC 20460. Do not send the foem to this address, DATAAfATRIX Date: September 17. 2003 EPA Reg NoJFi1e Symbol 

# .1 Page4of4 

# , 70506-13 • Applicanl'siRegi<;lranl's Name and Address: Product: Bifenthrin TechnicallnsccticidelMiticide . 

## , United Phosphorus. Inc. 423 Riverview PIIl7..a 

# . , Trenton. NJ 0&611 

## 1 Ingredieot: Bi(cnthrin (PC 128825)



## , Guideline Reference Number Guideline Study Name MRIDNumbcr Submitter Status Nole

, 133-3 (875.2400. 25(0).". Dennnl exposure CITBAIL UPI is II mcmbcroftbe Ag Re-entry las!.: Own 

# , force; UP1 is a member ofthe Outdoor

. Resk1ential TaskForce 1334 (857.2500) Inhalation exposure CITBAIL UPI is 8 memberof !he Ag Re-entry task Own </' force; UPI is 

### a member ofthe Outdoor ! Residential TaskForce 201-I,2{l2-1 (84O.1100{,/ Spray drift and droplet size CITBALL**Unisamem~ofWcSprayDrifiT~** Own 835.4200) Foree , 171-48
...... Nature ofresidue

- !ants CITBALL FMC 

### Pay I7I-4b 

## , Nature ofresidue-livcstock crrBALL FMC 

### Pay , , I7I-4e 

### I ResWue anal
.cal method**~** CITBALL FMC 

### Pa I7l-4d I Residue anal tieaJ. method

- animals CITBALL FMC 

### Pa 171-4e 

# , Residue stability crrEALL FMC 

### Pa , 1714' "'? Magnitude ofresidues mcatI

. {egg CITBAI.I. FMC 

### Pay I7I-4k I Magnitude ofresidues field crop trials CITBAI.I. FMC,IR4 

### Pay 171-41 \ Magnitude ofresidues

- commodities CITBAI.I. FMC 

### Pay 1714m/ Multi-residue method CITBALL FMC 

### Pav 165-1 

### v' Confined rouuional e CITBALL FMC 

### Pa 165-2 

### v' Field rotational CITBAIL FMC Pa

(j) V

Signature Name and Title Dale

### ~di<..u..~ Elizabeth Anne Brown, CbemRcg International, LtC 9117(2003 Regi$tration Agent EPA Form 8570-35 (9-97) Electronie and Paper versions available. Submit only Paper version. Agency Internal Use Copyhours perresponse for reregistration and special review burden estimate or any otheraspectofthis collection

Signature**~}.,....,~~** .ITEDSTATES ENVIRONMENTAL**P~ION** AGENCY 401 M Street, S.W.
lime to average in.'\truction and completingthe necessary forms. Send comments regarding the 10: Director. OPPE Infonnation Management Division (2137),

(RotC); The Seous Co (ScotlS); The Andersons Lawn Fertilizer Division. Inc.

\ndersons) 

### PI 

## n.

Name and Tit1e pay



### own

Eli:r..abeth Anne Brown, ChemRcg lmcmational. LtC Registration Agent Dale 911712003 EPA Form 8570·35**(9~~;I7YEieclrOnic** and Paper version.
.. available:-Submit only Paperversion. Public Flle Copy**------~-~** _.**~-'"'-** ..**~,---,-~--~---**

# ~ r"Ol1ll Approved OMB No. 2070-0060 oIIIIIiNlTED STATES ENVIRONMENTALPI!,IIIIII':CTlON AGENCY

..**4OIMS_~S.W."** WASWNGTON. D.C 20460 PaperworkReduction ActNotice: The public 

## reportirigi:iUidCn-roc this collectiOn of

### i"!lfOnnation is

## estima-te(iioavernge-0.25 hours per response for registration activilies and 0.25 "': hours per response for reregistration and special review activities, including time for reading theinstruction and completing the necessary forms. Send conunents regarding the bunlen estimale orany other aspect ofthis collection ofinformation. including suggestions for reducing the burden to: Director, OPPE Information Management Division (2137), U.S. Environmental Protection AftCncv. 401 MStreet. S.W.• Washington DC 20460. Do not send the Conn to this address.
Date: September 17.2003 Applicant'sIRc,gislrant's Name and Address: Unj!ed Pho.<tphorus, Inc. 423 Riverview PlIl7.a Trenton. NJ 08611 lngredient: Bifenlhrin (PC 128825)

### ~ DATA MATRIX EPAReg NoJ File Symbol 7051J6.18 Product: Bifenthrin TechniciI InsecticideJMjticide

E1i1.abcth Anne Brown. CbemReg International. LLC Page2of4

911712003 

# ,



# Ihours perresponse for reregistration and special

0) 

### CJ1 Signature dlllNlTED STATES ENVIRONMENTAL**P~ON** AGENCY

.. 401 MSt
.... t.S.W
... for reading the instruction and Send comments regarding the for Division (2137),

Name and Title Date

### ~.....,...,et....u.**~,J** Elizabeth Anne Brown. ChcmRcg International. LLC 911712003 Registration Agent EPA Foon 857(}"3S (9·97) Electronic and PllpCr versions**nvailable~-Submil** only Paperversion. PubUc File Copyand special

Dale: Name



# en

n

SignalUfC

### r'4j~"'-' 

# _dML. '4,.."",.,.J • ITED STATES ENVIRONMENTAL**PR~ION** AGENCY 401 M**Stree~S.W**•• instruction and**comp1etjn~** the necessary forms. Send comments regarding the !he burden 10: Director. QPPE Information Management Division (2137).

Name and Title Dale Eli1.abeth Anne Brown. ChemReg International, LLC 911712003 Registration Agent EPA Fonu**8570~35** (9·97) Electronic and Pnper vc.rsions available. Submit only Paper \'ersion. Public File Copy.... I '\.



# • "

1990 OLD BRIDGE ROAD, SUITE 201 LAKE RIDGE, VIRGINIA 22192·2383 DIRBCf: 703·492·1905 MAIN: 703-492-0445 Fax: 703-492o{)668 E-MAIL;brown@chemreg.com WBBSrrns: www.chemreg.com www.pestlcide.net 

### ELIZABETHA. BROWN, PH_D_ Sep.ember 5, 2003 Document Processing Desk (NOTlF) Office ofPesticide Progrnrns (7504C) 

### U.S. Environmental Protection Agency Room 266A, Crystal Mall 2 1921 lefferson Davis Highway Arlington, VA 22202-4501 Attention: Ms. SlIerarla Hobgood 

### Re: Notification ofOther Labeling Revisions. Bifenthrin Technical InsecticidelMiticide. EPA Reg. No. 70506-18 DearSherarla: On 

### behalfofour client, United Phosphorus, Inc., we are notifying for a change in the 

### medical emergency contactpbone number and the .YIarranty statement for the above product. This submission is under the notification procedure, as identified in PR Notice 98-10. As required by 

### PR Notice 98-10 for notifications, enclosed please find the following: I. 

### Application Fonn (8570-1) 2. One copy ofthe protiuc. labeling with changes highlighted. 

### Please let me know 

### ifyou have any questions about the enclosed items. Regards,

### ~

## ...**..,tt.v...~** Elizabeth Anne Brown


### cc: United Phosphorus. Inc.

CONSULTANTS TO

## sucCESS'" ••••

### •• 

# . ., • • •••

### ••• 

### • 

## •

•• ••••• 

### • • ••••• •••• 

### • •

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••• • 

### • ••• • 

### ••



### •• • • •••• 

### • •

•••• 

## • • • 

### ••

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### ••

Over One Hundred and FiftyYears ofCombinedExperieneeAssistingChemical, Pesticide,**Bio~Chemieal** andLife Science Companies on a Wide Range ofIssues,IncludingRegulatory Strategies,Registration, DataSupport and Compensation, QualityAssuranee, Study**Des~** and ScientifieMatters. 

# 071990 OLD BRIDGE ROAD, SUITE 201 LAKE RIDGE, VIRGINIA 22192·2383 DIRECT:**103·492~7905** MAIN:**?03~49200()445** Fax:**703~492-{)668** 

### ElJZABl!THA. BROWN, PH.D.


### Document Processing Desk (AMEND) Office ofPesticide Programs (7504C) U.S. Environmental Protection Agency 

### Room 266A, Crystal Mall 2 1921 Jefferson Davis Highway £..MAn.: brown@chemreg.com WRnSITBS: www.chemreg.com www.pest1clde.net



### October 6, 2003

• Arlington, VA 22202-4501



# • Ancntion: Mr. George LaRocca (pM 13) Re: Application for Label Amendment Bifenthrin TechnicallnsecticidelMiticide, EPA Reg. No. 70506-18 Dear George: On 

### behalfofour client, United Phosphorus, lnc., enclosed please find an application to amend the label for the above product This amendn'ient is to add food crop uses, identical to 

### those registered for tlle substantially similarproductEPA Reg. No. 279-3055 (approval date 5nJ2oo3). 

### Enclosed with 

### this 

### application please fmel; 1. 

### EPA Form 8570-1, Application 2. EPA Form 8570-34, Certification Witll Respect to Citution ofDatu 3. EPA Form 8570-34, Public File and Agency Use copies 4. Five (5) copies ofthe amended labeling, with 

### one copy highlighted to show the changes, 

### Please let me know if

### you have any questions or if

### anything funher is needed.

Elizabeth Anne Brown


### cc: United Phosphorus, Inc. 

### •••••• 

# . ., • • •••••• 

### • 

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## • • OverOne Hundred andFiftyYenrs ofCombinedExperienceAssistingChemical, Pesti<!iUl, Bio-Chemica1 andLife ScienceCompanieson aWideRange ofIssues, Including**Regu1Jft~** Strategies, Registration, Data Support and Compensation, QualityAssurance, StudyDM • and ScientifieMatters.

## • 

# oEPA UnIted States Environmental Protection Agency 

# o None Rtlstrlcted

2Z9=3Q55 ChockIf tills Is a newaddross EPA RegNo. ProdUct Nama elfonthrln TochnlcallnsoctlckfeIMltlcldo 

# o Aesubmlsslon In response to Agency Inllor dated NollficaUOn
- ExplaIn below

No

### ""'ffl.I~"!" must be submitted

81zabeth Anno BIO'Nr'I Aoancv letter daled 

# o "Me Too· AppUcation 

# D Other-explain below

No

,lie

### ~::~~:rntomational.LLC**~** Agent

October 14,2003 Auo. 25, 2003

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# • 1990 OLD BRIDGE ROAD, SUITE 201 LAKE RIDGB, VIRGINIA 22192-2383 DIRECT: 703-492"7905 MAIN: 703-492"0445 Fax: 703-492-0668 

### ELIZABETHA. BROWN, PH.D. Document Processing Desk 

### Office ofPesticide Programs (7504C) U.S. Environmental Protection Agency 

### Room 266A, Crystal MaJl2 1921 Jefferson Davis Highway Arlington, VA 22202-4501 Attention: Mr. George LaRocca (PM 13) Re: Final Printed Labeliog E-MAIL: brown@chemreg.com wnnSrrnsl www.chemreg.com www.pesticlde.net



### Bifenthrio Technical1nsecticidelMiticide; EPA Reg. No. 70506-18 Dear George: On 

### behalfofour**clien~** 

### United Phosphorus, Inc., enclosed please find 3copies ofthe final printed labeling for the above ProdUC4 per the notice. ofregistration dated August 25, 2003. Please let me know 

### ifyou have any questions. 

### Regards, 

# •

# ~**tt..J.Jf,&.~mJ** Elizabeth Anne Brown
cc: United Phosphorus, Inc.

CONSULTANTS TO 

### suCCESS'" • 

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# . Over One Hundred and FiftyYears QfCombinedExperienceAssisting Chemical,**p~s** .rude, Bio-Chemical andUfe ScienceCompanies on aWide Range 

### ofIssues,IncludingR**~tPrY** Strategies, Registration, Data Support and Compensation, QualityAssurance, Study es\s.r! and ScientifieMatters. ' ••••:{

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United Phosphorus, Inc. 423 Riverview Plaza Trenton, NJ 08611 Untted Statos Environmental Protection Agency 

# ,

(b)O). to: EPA Rog No. Amendment Other

Restricted

ChockIfthis Is 11 newIlddtess Product Name

Notif\catlOfl.
- Explain below

por 98-10.

Yes y", No No must besubmItted wgt
Container

Enzabolh Anne 8rown I , Aooncv [etterdated 

# o "Me Too· AppllcaUon 

# o Othcr- Explain below

40 CFA 152.46, end no otherchangos have boon modo a violation of 1BU.S.C. Sec. 1001 to Willfully mako any terms ofPA Nollce 98-10 and 40 CFA 152.46, this

No wgt 

# "

ChemReg IntemallonaJ, LLC Authorized Agent
September 5, 2003 P""tJc G'"", Papo' other (Specify)



## • •••• • •



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# 73**.,--------,-,---~------------- --------------------~-**  "



# •

• ACTIVE INGREDIENT: 

## Bifenthrin Technical InsecticideIMiticide FOR FORMULATION USE ONLY
Bifanthrin: (2-mathyl[1,l' -bfphenyl]-3-yl) methyl 3-(2-chloro-3,3,3·trlfluoro-1-propanyl) -2,2-dlmethylcyclopropanecamoxylate"

................................................................................. 99.4% OTHER INGREDIENTS

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

................................................**~** TOTAL •....,..............................................................................................,.............•.,...................•,.... 100.0% ·Cls isomers 97% minimum, trans Isomers 3% maximum. 

### KEEP OUT OF REACH OF CHILDREN WARNING United Phosphorus Inc. 423 Rlvarvlew Ptaza Trenton, NJ 08611 FIRST AID EPA Reg. No. 70506·18 EPA Est. No.

Heve the product contalner or label with you when calling a polson control center or c!octor, or going for treatment. II swallowed 

## • Call a polson control center or doetor immediately for treatment advice. 

## • Have person sip 

### a glass 01 water II able to swallow. 

### • 00 no1lnduce vomiting unless told to do so by a polson conlrol center or doctor. 

### • 00 not alve alve anVlhlna bv mouth to an unconscious erson. IlInhated 

### • Move person to fresh air. 

## • 11 person Is not breathing, call 91 1 or an ambulance, then give ertlficlal**resPI:,=~** preferably mouth-to-mouth, Ifpossible. 

## • Cail a on control center or doctor for further treatment advlCi!. If on skin or clothing 

### • Take of! contamlneted clothing. • Rinse sldn Immediately with plenty of water for 15-20 minutes 

### • Call a DOison controt center ordoctor lor treatment advice. II In eyes 

## • Hold eye open and rinse slowly and gently wilh water for 1&20 minutes. Remove contact lenses, If prasent, alter the first 5 minutes, then continue rinsing eye. 

### • Cell 

### a ooison control canter or doetor lor lreatment advice.

PRECAUTIONARY STATEMENTS

...... 

### •• • 

## " 

# .. • 

### Hazards to Humans (and Domestic Animals) : .: .... 

### • • Warning •••••• • ••• May be latall! swallowed. Hermfullf Inhaled or absorbed through the skin. Causes moderat69jO IrritetLoo.•" Avoid breathing dust. Avoid contact with skin, eyes, or clothing, Remove contaminated cleW",and weiltl-' : before reuse. Wash thoroughly with soap and water after handling and belore eeUng, driniOOlJ,.' using • tobacco. 

### Environmental Hazards 

## .,

# .. • •

"" 

### • • • 

## •• This pesticide is toxic to fish and aquatic invertebrates. Do not discharge ollluent containing this product" •• Into lakes, streams, ponds, esluaries, oceans, or public waters unless In accordanca with the requirements 01 a National Pollulant Discharge EllmlnaUons System (NPDES) permit end the permitting authority has been nollfled In writing prior to discharge. Do not discharge effluent con1alning this product to sewer Page 1 

# 74 L--
_____________________ _

### ,



# • systems without previously notifying the sewage trealmonl plant authority. For guidance, contact your State Water Board or RegIonal Office ofthe Environmenlnl Protection Agency. 

### PhyslcaVChemlcal Hazards Do not use or store near heat or open flame. 

### DIRECTIONS FOR USE It Is a vIolallon of Federal law to use this product In a manner InconsIstentwith Its labeling. This material requires further mixing before use Onlv forformulation Into**.n'ln&&Cttcld~ltJclde** for Terrestrial Non·Food: Termllicldo and Soli Contact Nonfumigation Treelmenl Wood Treatment and Protection Ouldoor Insect Control Ornamental plante, trees, shrubs, and vineo (WOOdy) Residential Lawns Indoor Insacl Conlro! Non·FoodIFecd Areas: Mav be used to manufacture end-use products for usa os a spot or crack and crevlce-trealment In nOn-food areas. Similar areas where Insects hide or through which loseels may enter can be treated. Examples of non.food areas include: garbage rooms, lavalories. floor drains (to sewers), entrles. and vaSllbules, otnces, locker rooms, machine rooms, boUer rooms, garages, mop closets, and storage (after canning and bottling). FoodIFeed Areas: May il2l be used to manufacture products for use In foodlreed arees. Do not use in food areas-offood handling establishments, restaurants, or otherareas where food Is commercially prepared or processed. 00 not use In serving at'e<!S while food Is exposed orfacility Is In operation. SaNing areas are areas Where prepared food are served such as dining rooms but excludIng areas where foods may be prepared or held. In the home ail food processing surfaces and ulenslls should becovered during treatmenl or thoroughly washed before use. Exposed foods should be covered or removed. Examples offood areas are areas for receiving, atoragelpacklng (canning, bOIUlng, wrapptng, boxing). preparing, edible wastes, slorage and enclosed processing systams (mills, daIries, edible oils, syrups), Serving areas (when food is exposed and faclhty Is In operallon) also would be consIdered a food area. (2) Uses forwhich U.S. EPA has accepted the required data aneVor clmUon of data that tho formulator has submitted In support of raglstraUon; and 

# e (3) Uses for experimental purpoGOs that are In compliance with U.S. EPA requirements. Formulators using this product are responsible for obtaining U.S. EPA registration fortheir formulated prodUct which may be labeled forthe use patterns 85 found listed on this label.

Page 2 •••••• 

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•**~--------~-~--~-~--**



### Storage and Disposal Do not contaminate water, food, orfeed by storage and disposal. PESTICIDE STORAGE Keep out 01 reach of children and animals. Store In original containers only. Siore In a cool, dry place and avoid excess heat. Carefully open contaIners. After partial use, replace lids and close Ughlly. Do not put concentrate or dilute maleria/lnto food or drink containers, Do not contaminate other pesticides, fertilizers, waler, food, or foed by storage or disposal. In case of spill, avoid contact, Isolate area, and keep out animals and unprotected persons. Confine splils. PESTICIDE DISPOSAL PesticIde wastes ero toxic, Do not contaminate 

### waler. food orfeed by storage or disposal. Improper dlSposel of excess pesticide, spray mIxture, or rlnsate Is a violation fa Federal law. Dispose of excess wasle or pesticIde by use according to label directions, or conlact your Slate Pesticide or Envlronmenlal Control Agency, orthe Hazardous Waste representallve at the neamst EPA Regional Office for guidance. CONTAINER DISPOSAL Completely empty liner by shaking and tapping sides and bottom to loosen clinging partiCles. Empty residua Into appllcallon equipmenl. Then dispose of Hner In 

### a sanitary landfill orby Inclnerallon, if allowed by State and local authorities. If drum is contamlnaled and canhol be reused, dispose of In Ihe same manner.

FOR CHEMICAL EMERGENCY: Spill, leak, lire, exposure, or accident, call CHEMTREC 1-800424-9300

Page 3 

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• CONDmONS OF SALE AND UMITATION OF WARRANTY AND LIABILITY

Page 4 EPA Approved. 0812512003 Revision (notilicatlon): 0910512003



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## , U.S. ENVIRONMENTAL PROTECTION AGENCY EPA Re,. Nwnbtt:**Dal~** orlnw.n<:e!**~..,.,,~** Office orpt$liti&:**~** 

### 70S<J6..18 

## AUG 25 2003 RqbtntiOfl Divislotl (7505C) 

# t-) 1200 rcrw)l>$ni. A",. N.W. WuhinglOll. D.C.lOOO4 

# ,;:7**Telmor~:** 

### Conditional NOTICE OF PESTICIDE: ..lL

### Registration N..- orl'atiel&: Prodvc:t:**(Wldnf1FRA.u~)** _ 

### Reregistration Bifenthrin Technical lnsecticidelMiticide

Nllna and Addrlll 01 Rflglllr.nl linclud. ZIP Cod.l: 

### United Phosphorus, Inc. 423 Riverview Plaza Trenton, NJ 08611
Notr. a..tI;es in bbelins4iffai

.... ill**~** rrom thai KUpUd in**~** II-ilh \hU;**~UOfl** mlm**~** submitted 10 I!Id**~** by the**~Wlltion** Division priorIII \U('oClhcI WocI in comlllCf'l;e. IA iUIY**~** 011 this pruclvcl always**~rer** 10 !hi: .bow: EPA**~JUtrnion** number. On thebuis oCinronndion**runu~** bythe**~** the &bow: !111M<! peslieidl: ;, hereby**RgiJlcml/~retisten:d** UIIdtt!beFedaalln:$«Iieide. FUIlpeide and ROIknlili&: > - ! A
... RqirIration is in 110 way 10be coratnxIdII an**~** or =mmc!ldaUOllorlhis prodUCl bythe: AIft\CY. In orokr 10 proICCt ImIIh I!Id the mvircnmCnt, the:**AcInI~.** 011 bilmotion. ou.)I

...1lIIYtinIc NfllCIId or an«1 therqistn.tiC!ll or.p¢$lielde in**~** willi the An The aeteptMctorany name in toI\MCtion wilh !be rqIS!lIIion or. produd UIldtrthis Act Is ROllO be «II!StnICd lIS ;ivinsthe**~;iJtram** I ""'110 tlCe!usive uw orthc: Mrm: 01' 10 ItJ lISt Irllhas been covrred by othm.


### This product is 

### conditionally registered in 

### accordance with FIFRA sec. 3(c)(7)(A), subject to the fonowing provisions:

- 1. 

### You must submit and/or cite all data

### required for registratiOn/reregistration ofyour product under FIFRA sec. 3(cXS) when the Agency requires all registrants ofsimilarproducts to submit such data; and submit acceptable responses required for reregistration ofyou product under FIFRA section 4. 

### 2. Yau have applied for the registration ofaproduct containing the active ingredient bifenthrin. The Agency 

### has recently conditioned the original registration ofwhich you are a follow-on with a new data requirement. Acopy ofEPA's letter, dnted May 7, 2003, notifying FMC Corporation ofthe new data 

### requirement is enclosed. As 

### stated in paragraph I. this registration will also be conditioned with 

### that data requirement. Accordingly. you must take steps to ensure that these required data are submitted. The steps could include generating and submitting the data yourself. oryou may offer to share with other registrants the cost ofconducting testing. The data requirement being imposed on this registration is as follows:

# ~;M:~J.- t:-" !hie: 

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...

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## AUG 

## 25 2003

A EP**Fcnnl~**

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### --- - ------------ ---**--~----~--**



# . ACCEPT 

### withCOl\lME 

### In

### EPALetter

### D ED



### NT8

aled; 

## Blfenthrln Technical PlJ6 

## 25 2003 InsecticideIMlticlde _Iholi'

.......

## ~~fortbo hIsoeUW!e,**~A<:'"**

# F~ FOR FORMULATION USE ONLY 

# :!':to2t.!' ACTIVE INGREDIENT: Blfenthrfn: (2-methyl{1.1 '-biphenyO-3-yl) melhyl 3-(2-chloro-3,3,S·trfnuoro-1·propenyl) ·2,2·dlmethylcyclopropanecarboxylale·

................................................................................. 99.4% l!.§li. % OTHER INGREDIENTS .........•...•...............••.•.....•...••••.....•...........•.•...•.........•.......•..........,..................... TOTAL
............,........"•.........•.•.•...............,.••,...............................................,..........,......•...••............. 100.0 ·CIs Isomers 97% minimum, trans Isomers 3% maximum. 

### KEEP OUT OF REACH OF CHILDREN WARNING United Phosphorus Inc. EPA Reg. No. 705(J6. 423 Riverview Plaza EPA Est. No

. Trenlon, NJ 08611 FIRST AID

Have the product container or label wllh you when calling 

### a polson control cenler or doclor, or gOing for treatment. If swaDowed 

## • Can 

### a poiSon control center or doctor Immediately for treatment advice. 

### • Have person sip a glass ofwater If able to swallow. 

### • Do not Induce vomliing unless told to.do so by a polson control center or. doctor. 

### • 00 not alve alVe anvthlna bv mouth to an uncons(:Jous nemon. If Inhaled 

## • Move person to fresh air. 

### • If person Is not breathing, call 911 or an ambulance, then give artificial respiration, preferably moulh-to-mouth, If possible. 

### • Call 

### a DOlson control center ordoctorfor furthertroalment advice. If on skin or clothing 

### • Take off contaminated**~Iothlng.** 

## • Rinse skin Immedlatelywith plenty ofwater for 15-20 minutes 

### • Call a Mlson control canter ordoclor for lrealment advice. If in eyes 

## • Hold eye open and rinse slowly end genny with water for 15-20 mlnules. Remove contact lenses. If present, afterthe first 5 minutes, then continue rinsing eye. 

### • Call a- colson control center or doctor fortreelment advice. FOR 24-HOUR EMERGENCY MEDICAL ASSISTANCE, CALL CHEMTREC 1-80D-424-9300 

### PRECAUTIONARY STATEMENTS Hazards to Humans (and Domestic Animals) 

### •••• 

### • 

## •

•••• 

### Warning May be falallf swallowed. Harmful If Inhaled or absorbed through the skin. Causes moderate eye Irrltan 

### ••• on.. •• h ••• Avoid breathing dusl Avoid conlact with skin, eyes, or clothing. Remove contamlnaled clothing and was before reuse. Wash thoroughly with soap and waltH after handling and before eating. drinklng, 

### 4r-dfr'll tobacco. 

### • • 

### •••••• 

## • • Environmental Hazards 

## •• this pesticide Is toxic to fish and aquatic Invertebrales. Do nol discharge emuent conlalning this·**~*~** into lakes, streams, ponds. esluerles, oceans, or pubic waters unless In accordance wllh the requ remen oj. a National Pollulant Dlscherge Eliminations System (NPDES) permit and the permitting authority has been notJfled In wrlilng prior to discharge. Do not discharge elfluenl containing this product to sewer Page 1 IS 

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# 79

# •

• syslems WIthout previously noUfying the sewage treatmont plant authority. For guidance, contaci your Slate Water Board or Regional Office ofthe Environmental Prolectlon Agency. 

### PhysicaVChemlcal Hazards 00 nol use or slore near heat oropen flame. 

### DIRECTIONS FOR USE It Is a violation of Federallsw 

### to use this product In a manner Inconslslenl with Its labeling. This material requires further mixing before use Only forformulation Into an InaocUo!delmlUcldo for Terrestrial**Non~Food:** Torml!lclde (and SoU Contact Nonfumlgallon Trentmonl Wood Treatment and Protection Outdoor Insect Control Ornamental plants, trees, shrubs, anCJ vInas (woody) Resldonllal Lawns IndoorInsect Control**NDn~FoodIFeed** Areas: May be used to manufacture end-use products lor use as a spot or crack and crevice treatment In**non~food** areas. Similar areas where Insects hide or through which Insects may enter can be trealed. Examples of non-food areas Include: garbage roome, lavalorles, floor draIns (to sewers), enlrles and vestibules, omcee, locker roome, machine rooms, bOiler rooms, garagas, mop closets, and storage (after canning and boWIng). FoodIFoed Areas: May1lQ.tbe used to manufacture products for use In foodlfeed areas. Do nol use In food areas offood handling estabHshments, restaurants, or other areas Where food Is commercially prepared or processed. 00 not use In serving araas while food Is exposed orfacmty Is In operation. Serving areas are arens Whem prepared food are served Buch as dining rooms but excludlng areas where fOOds may be prepared or held. In the home aU food processing surfaces and ulenslls should be covered durIng treatment or lhoroughly washed belore use, Exposed foods should be covered or removed. Examples of food areas are areas for receiVing, storage/packing (canning, boWing, WrBRllng. boxing), preparing, edlble wastes, slorage and enclosed processing systems (mills, dairieS, ed1b1e oils, syrups). Serving areas (when food Is exposoo and facility Is In operation) also would be considered a food area. (2) Uses forwhich U.S. EPA ha. accepted the required data andlor citation of data thatthe formulator has submitted In support of registration; and (3) U80siorexperimental purpoBGS thatara In compliance with U.S. EPA rel:julromonts. Formulators using this product are responsible for obtaining U.S. EPA regIstration forthefr formulated productwhich may be labeledforthe use patterns as found listed on this label.

Page 2 

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# 80

# •

• Storage and Disposal Do not contamInate water, food, orfeed by storage and disposal. PESTICIDE STORAGE Keep out of. reach of children and animals. Store In original containers only. Store In a cool. dry place and avoid exceSG heat.' CarefuITy cpon contaln'era. After partial use, replace lids and close tightly. Do not put concentrate or dlJute material into food

## or drink conlalnors. Do not contaminate other pesticides, fertilizers, water, food, orfeed by storage or disposal. In case of spill. avoid contact, Isolate area, and keep out animals and unprotected persons. Confine spills. PESTICIDE DISPOSAL Pesticide wastes are toxic. Do not contaminate water, food orfaed by storage or disposal. Improper disposal ofexcess pestlclda, spray mixture, orrlnsate Is avlolallon fo Fadera"ew. Dispose of excess wasle orpesticide by usa according to label directions, orconlaet your State Pestlclde or Environmental Control Agency, or the Hazardous Weste representative 01 the nearest EPA Reglonet Office forguidance. CONTAINER DISPOSAL Completely empty nnerby shaking and tapping aides and bottom to loosen clinging partlcles. Empty residue Into appllcatlon equlpment. Then dispose of nnerIn a sanitary landfill or by Inclneratlon, If etJowed by State and local authorities. It drum Is contamlneted and cannotbe reused, dlspose of tn the same manner.

, FOR CHEMICAt. EMERGENCY: Spill. le"ak, fire, exposure, or accidant. call CHEMTREC**1~80D-4249300**

Page 3 

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# 81

---------------------------

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• CONDITIONS OF SALE AND LIMITATION OF WARRANTY AND LIABIUTY NOTICE: Read the entire Dlrectlons for Use .and Conditions of Sale and limitation of Warranty and Liability

. before buying or using this product. If the terms are not acceptable, retum the product at once, unopened, and fhe purchase price will be refunded. The Oirections for Use of this product should befollowed carefully. It Is Impossible to eliminate all risks Inherently associated with the use of this product. Crop Injury, Ineffectiveness, or other unintended consequences may result because of such faclors as manner of use or appllcatlon, weather**o~** crop conditions. presence of other materials or other Influencing factors In the use of the product, which are beyond the control of United Phosphorus or Seller. All such risks shall be assumed by Buyer and User, and Buyer and User agree to hold United Phosphorus and Seller harmless for any claims relating to such factors. United Phosphorus warrants that this product confonns to the chemical description on the label and Is reasonably fit for the purposes stated in the Directions for Use, subject to the Inherent risks referred to above, when used In accordance with directions under nonnal use conditions. This warranty does not extend to the use of Ihis product conlrary to label Instructions, or under abnormal conditions or under conditions not reasonably foreseeable to or beyond the control of Seller or Unlfed Phosphorus, and Buyer and User assuma the risk of any such use. UNITED PHOSPHORUS MAKES NO WARRANTIES OF MERCHANTABILITY OR OF FITNESS FOR A PARTICULAR PURPOSE NOR ANY OTHER EXPRESS OR IMPLIED WARRANTY EXCEPT AS STATED ABOVE. In no event shall United Phosphorus or seller be liable"for any incidental, consequential or special damages resulting from the use or handllng of this product. THE EXCLUSIVE REMEDY OF THE USER OR BUYER, AND THE EXCLUSIVE LIABILITY OF UNITED PHOSPHORUS AND SELLER FOR ANY AND ALL CLAIMS, LOSSES, INJURIES OR DAMAGES (INCLUDING CLAIMS BASED ON BREACH OF WARRANTY, CONTRACT, NEGLIGENCE, TORT, STRICT LlABIUTY OR OTHERWISE) RESULTING FROM THE USE OR HANDLING OF THIS PRODUCT SHALL BE, AT THE EL!ECTION OF UNITED PHOSPHORUS OR SELLER, THE REPLACEMENT OF THE PRODUCT, OR COMPENSATION LIMITED TO DAMAGES NOT EXCEEDING THE FARE MARKET PURCHASE PRICE, AND SHALL NOT INCLUDE INCIDENTAL OR CONSEQUENTIAL DAMAGES• United Phosphorus and Seller offer Ihls product, and Buyer and User eccept It, subject to the foregoing conditions of sale and limitations of warranty and of liability, which may not 

### be modified except by written agreement signed by the duly authorized representative of United Phosphorus. Pending, not EPA Approved. 08/15/2003


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# 82

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• 1990 OLD BRIDGE ROAD, SUITE 201 LAKE RIDGE, VIRGINIA 22192-2383 Dmncr:**703~492'''905** MAIN:**703~49200()445** Fax:**793~492~o668** E-MArr..: brown@chemreg.com Wlm SlTBS: 

### www.chemreg.com www.pesticide.net 

### ELIZABETH

### A. BROWN, PH.D. August 15. 200l 

### Document Processing Desk U.S. Environmental Protection Agency (7505C) 

### U.S. Environmental Protection Agency Room 266A. Crystal Mall 2 1921 Jefferson Davis Highway Arlington. V

### A22202-4501 Attn: 

### George LaRocca (pM 13) 

## •••• 

## • •• 

## • • 

# ·

# ...... 

# . ,



### •• •••• 

### • • •••••

Re: Bifenthrin Technichl InsecticidelMiticide (EPA File Symbol 70506-RI) Response to Agency letter ofAugust 6, 2003
Dear George: 

## •••• • •

••••



## •

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### •• 

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On behalfofour client, United Phosphorus, !Dc., this letter is in response to the Agency letter ofAugust 6. 2003. regarding the above application forregistration. As a condition ofregistration, United Phosphorus, Inc. (UP!) 

### agrees to provide the additional data 

### required to 

### support registration, as identified in 

### your letter (data

### requirement OPPTS 870.6300, developmental neurotoxicity study). UP! will offer to cost share with other registrants. Please provide me with 

### a copy ofthe data call-in sent to the otherregistrants or other documentation ofthe Agencyrequirement to otherregistrants.**(p~**

# .. 

# e./""*I F",I441**,~** t/o-,r.lu(**F~G** 

### / 

### /•**.f'~(** 

### ....



## I'/t>J}

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### Attached please find data matrix forms (EPA Form 8570-35). revised to identify data 

# % "'j.z.:;,<<< supporting Guideline 84-4 

### (other genotoxic effects), as 

### required in the Agency letter. Also .,

### ~~ enclosed is a 

### revised Cenification with Respect to Citation ofData (EPA

### Form 8570-34); 

### offers 

## n.f' have been sent to otherregisttants to address 

### the additional data requirement. 

### The data 

### matrix also 

### has been revised to reflect the MRIDs of

### the studies submitted by 

### UPl in support ofthis application.
.

CONSULTANTS TOSUCCESS"' OverOneHundred

### andFiftyYears 

### ofCombined ExperienceAssisting 

### Chemical, Pesticide, Bio-Chemical andlifeScience Companies on

### a Wide Range ofIssucs, 

### IncludingRegulatory Stnltegics, Registration, DataSupportandCompensation, QualityAssurance, StudyDeSWh 

### andScientifie Matters. 00

# •

• Letter to 

### G. LaRocca, August 

### 15, 2003, page 

### 2


### Also enclosed are five copies ofthe 

### draft 

### label, revised as required in 

### the Agency letter, along with one higblighted copyto identify the cbanges. Final printed labeling will be submitted 

### once the Agency bas registered this product and prior to release ofany product for shipment. Thankyou for your attention to this matter. Please contact me immediately ifthere are any questions or if

### anything further is needed. Regards,



### Elizabeth Anne Brown

cc: 

### United Phosphorus. Inc.

!



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# c:J Reaubml&8lon In response to Agency leUer datedAUg, 6. 2OQ3 NoUficatlon
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.....- UNrrED STATES ENVIRONMENTAL PROTECTION AGENCY

### ,,~ 401 MSTREET. S,W, WASHINGTON, D.C. 20460 Paperwork Reduction Act Notice; The public reporting burden for this collection of Inlonnallon Is estimated 10 average 1.25 houts par response for registration and 0.25 hours per rooponso for reroglmraUon and special mvlow activities, Including time for reading tho Instructions and comp/oUng tho necessary forms. Send comments regarding burden estimate or any other aspect of this collect/on of Information, Including suggestions for reduclng the burden to: DIrector, OPPE Information Management Division (2137), U.S. EnvliuMlenta/ Protection Agsncy. 401 M Street. S.W., washington, DC 

# ,**~:i**

# .."", ifo 

# "" • with I Appllcant'slFlogl$trant's Name, Address, and Telephone Number EPA Registration NumberlFlle Symbol**~;7** Phosphorus. Inc. 70506-RI Rlvervlow Plaza ,N.! and/or reprosenta.tIvtt lest compound(s) Dale



# ..

# " I product L.l$lng 40 CFR Part 15B)

# ~

# ~"YO"" ,'00%., I producHBbeIGd for IlII tho aome Ll$CS on your label, you do not need 

# 0 I am responding 10 a Data-CaIJ·ln NoUce, and have InclUded mth this fonn a list of companies sent offers 01 compensation (the Data Matrlxfonn should be used for this pUt'pO(lo).



# , 

# 0 I am usIng the clle-a11 method of supPort, and have Included with 

# 0 I am usIng theselecUve**m~olfSupport** (orCIte-alloptlon this form a IIsl of companIes sent oHem ofcompensallon (the Data under have Included with this lonn Matrix lonn shotJld be UIOO for thil purpose) m",' .,.;-,;;;,;):' ."., I {the Deta Malrix fonn ) PAY (Required If using tho cUe·all molhod, or ooen uslngthe clle-all option undor the selectIve method 10 satisfy one or mora data requirements) 

# 0 I hereby offerand agree 10 pay compensatlon, 10 other persons, with rego.rd to the approval 01 this application, to the extenl required by F1FRA



# .. ,10 

# , I submftled orclled In 

### j'';i ' 1_,;1thO, I lIop'on , I 1b

## ;~~~~_~_of**":i~r::;.:,~** In, II

## ~**':"~1211 ~_"!~** **~ ,.;;~**  ollhl,.**'~I** I I**,...,g~'** Identical or similarcomposlUon and usos. I certifythatfor each exclusive use study cited In support ofthis registration or rerogl8lratlon. thai Iam the original data submitter orthat I have Oblalned tho written pennl$s/on 01 the orfglna! deta Gubmlttedlo clle thaI study. I certifythaI for each study cited In support 01 this registration or reregialruUon that Is nol an oxcIuslve use sludy. either: (e) I am the origInal data submitter; (b) I have obtained the pennlsslon ofthe origInal data sUbmltter 10 use tho study In support ofthll application; (e) all periods ohligIbJUtyfor compensation have expired for the Sludy; (d) the sludy Is In the public lllemluro; or (a) I have notified In writing the company thaI submlf'tid.tNt\ludy and have offered (I) to pay compensation lothe extent required by sections 3(c)(1)(F) and/or 3(e)(2)(9) of FIFRA; and (II) to commence negotJr4ll0Q510 detennlne tho amount and lonns of oomperuw.tIon, II any, to be paid for the use 01 the sludy. • ••••• I certify thai in all Instances where an offer 01 comparnmUon Is required, copIoo 01 all offem 10 pay oomperuw.tlonoamleW:Ience ofthoirdellvery In accordance with sections 3(e)(t)(F) and/or 3(e)(2)(9) of F1FRA ere available and will besubmitted to Ihe Agency upon rOquetrt. :Should.! Iail**~** produce such evidence to the Agency upon request I undersland that tho Agency may InlUalo action 10 deny, cancel orsUSpendJlJ\**MImtIOlO1f~UCl** In conlonnrty v.ith AFRA • • • 

### •• 

### • •••

. ' I cet1lfythat**th~** ataloments I have mado on this form snd all attachments 10 It ara true, accurate, end COI\lp\D&Q, I**IICkn~lIIlet1g:** thaI eny knOwfnglyfel

..or mIsleading statement may ba punIshable byfino or Imprisonment of both under appllcablo I\"V':..• •

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## ~~:SI14,2003 

# I**~~M:"TI"",,"** j Nrun
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## ~ The I for reregistmtion and sp spectofthlsc_ • A_.....". 401 M Street, S.W..
t 14, 2003

. - -'sNnmel Inc. Plaza 11

;0)**~O)** y l'!lUllt; Chemicali Slaltin materials and tru

....xmation of impurities

cUmina!)'**a-~I**..**~:~** :rtification t I method w-,,- \,lJV.UWz) Color 63·3 (830.6303) Physkal stat 63-4 (830.6304) Odor None (830.7050) UVNisible,

1 63•51

63-7**~** 830.7840) •• • ••, JOMB No.;**~** STATES ENVIRONMENTAL P.CTIONAGENC'( 401 M SI...., S.

## w. :Jforl



# . . ,- 

### r. D.C. 2&460 5hours per response for I

.. gthe instruction and completing the necessary forms. Send comments regarding the

for reducing**~** burtlCn to: Director, OPPE Information Management Division (2137), e. form In Ihlc:

MRIDI 45654401 45654401 45654401 45654401

:45654**~**

14600850: I rrrn. At. 

## IEPA I

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,UPI

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## ruPf

, UPI

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# INote

53.,(830.7950) :.: .: ' Vnoorores..o;ure ClTEALL FMC:S;**~**10 (830.7370) •• .... .. Dissociation constant CITE ALL FMC. : 1(830.7550) OctanoVwaterpartition CITEALL FMC.: icons. icolts. w·,2 (830.7000) ipH 45838001 UPI own I Qj)63.13 (831).631,», •••**'IIabil~y:** 45654403 UPI own I

- I

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# .... .. 

# ...... .... .. • Signature Name and Title Date **Y.l.l .•.** **~I.A_ ••** **~ ~1i~~~AnnAeBrown,CbemReglntemational.LLC**  811412003 

## , 

# , EPA Form 857(}'35 (9·97) Electronic and Paper' it only Paper'"""" P'" speciaJ burden armis



### ..7.....4
... '**~.,.J** .NITEDSTATES ENVIRONMENTAL 401M**~ECTION** AGENCY
response including; time for necessary forms. Send commenlS regarding the burden ..... Information Management Division (2137).

elizabeth Anne Brown, CberoReg International, LLC 811412003 

## ']

# I 'I 

## I \



## i



## I______________________________________________**~---------------**--, -

# \~ 

# .NlTED STATES ENVIRONMENTAL pe-ecnON AGENCY Fonn Approved OMB No. 207(M)()6() 401 AI Street, S.W. WASHINGTON D.C. 20460 Paperwork Reduction Act Notkt: Thepublic reporting burden for this collection ofinformation Is estimated to average 0.25 hours per

### response for registration activities and 0.25 hours perresponse for megistralion and special review activities, including timefor reading the instruction and completing the necessmy Conus. Send conunenl$ regarding the burden estimate orany otheraspectofthis collection ofinformation. including suggestions for reducing the burden to: DireclOC. OPPE Infonnation Management Division (2137). U.S. Environmental Protection A2eDCY. 401 M Street.. S.W
.. Washin2tOn DC 20460. Do not send the form to this addres.s. DATA MATRIX Dale: August 14.2003 EPA RegNoJ File Symbol 

### 1 Page30f4 70506·18 Applicant'slRegislrnnt's Name and Address: Product: BifenthrinTechnical InsecticideJMiticide United Phosphorus. Inc. 423 Ri\'crview PI37lt Trenton.NJ 08611 Ingredient: Bifenthrin (PC 128825) Guideline Reference Number Guideline StudyName MRIDNumber Submitter Status Note 82·2 (870.3200 21-0a dermal loxicil -.rots CITE ALL FMC. Scotts Andersons Pa 82-7 (none) Subchronic neuroloxicit

- rat CITBALL FMC. ScotlS, Andersons 83-1a (870.4100) Chronic fecdi toxicity

- rodent CITE·ALL FMC.

# _IS, Anden;ons Pa 83-lb (870.4100) Chronic feeding toxicity

- dog Cl'fE.ALL FMC, Scotts, Andersons Pa 83·20 (870.4200) Oncogenicity

- rat CJTE.ALL FMC. Scotts, Andersons Pay 83·2b (870.4200 Oncogenicity· mouse Cl'fE.AL FMC. Scotts. Andersons Pay 83-3n (870.3700) Teratogenicity· rat CITE-ALL FMC, Scotts, Andersons Pay 83·3b (870.3700) Teratogenicity

- rabbit CITE-ALL FMC, Scotts. And.ersons Pay 

### ".. OPPTS 870.6300 Developmental Neurotoxicity Data
... 84--2 Mu Ilicit studies Cl'fE.ALL FMC. Scotts, Andersons Pay 

### v 84-4 OWer notoxic effects Cl'fE.ALL FMC. Scotts. Andersons P 85·1 (870.7485) General metabolism CITE·ALL FMC, Scotts, Andcrsons Pa 85-2 Dermal '00 Cl'fE.ALL FMC. Scotts. Andersons Pa 161-1 Hydrolysis CITE ALL FMC. Srotts. Andersons Pay 161-2 Photodegradationin water CITE ALL FMC. Scotts, Andcrsons Pay 162-1 Aerobic soil metabolism CJTE.ALL FMC, Scotts. Andersons Pay 163-1 Adooll'lionldeson>tion CITE ALL MC. Scotts, Andcrsons Pay 164-1 (875.2200) 

### • • 

### ••• Held soil disshmtion CITE-ALL FMC. Scotts. Andersons Pay 

### • • 165-4 • Bioaccumuilltion in fisb Cl'fE.ALL FMC. Scotts, Andcrsons 

### • ••• • Soecial studies 

### • •• •

### • Other CITE ALL IhroidWorkin Grot! 132·1 (857.2100) Foliarresidue dissipatioo CITE ALL FMC. Scotts. Andersoos Pa 

## ex> CD 

### • • 

### • ••• • ••

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### • 

## •• • 

### ••• • • 

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### ••

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### • ••• • Signature Name and Title 

## o.te**~**...... ""'-u.. 

## <&..c"".....,. Elizabeth AnneBrown, ChemReg InlcrnationaJ. LLC 8/1412003 Registration Agent EPA Fonn 8570·35 (9·97) Electronic and Papcr versions available. Submit only Paperversion, JIgen<)' InIe_ Use Copy 

### . •



# I

# ~~ 

# .rrno STATES ENVIRONMENTAL peECTIONAGENCY Form Approved OMS No. 2070-0060 401 M**Stree~** S.W. WASHINGTON. D.C. 20460 PaperworkReduetion Act Notke: The public reporting burden for this collection ofinfonnation is estimated to average 0.25 hours perresponse for registratinn activities and 0.25 

### • hours perresponse for reregistration and special review activities, including time for reading Ihe instruction and completing the necessary forms. Send comments regarding the burden estimate or any otherns:pecl oflhis collection ofinformation. including suggestions for reducing the burden to: Director, OPPE Information Management Division (2137), U.S. Enviroomental Protection A2eIlCY. 401 M Street,S.W
.. Wasbir:Igt,on DC 20460. Do JlO{ send theform to lhis address. DATA MATRIX Date: August 14. 2003 EPA Reg Nol File SymboJ 

# IPage4of4 10506-18 Applicant'slRegislrnnl'S Name and Address: Product: Bifenthrin TechnicallnseclicidelMiticide United Phosphorus. Inc. 423 Riverview Plaxn Trcn!On, NJ 08611 Ingredient: BiIentbrin (PC 128825)
Guideline RclCrencc Number Guideline Study Name MRlDNumber Submitter Status Note \33·3 (875.2400. 2500) Demutl exposure CITE ALL UPI is a member oftbeAg Re-entry task Own force; UPI is a member ofthe Outdoor Residential Task Force 133-4 (857.2500) Inhalation exposure CITE ALL UPI is a member oflbe Ag Re-entry task Own force; UPI is a member oflhe Outdoor Residential Task Foree 201·1.202.1 (840.1100. Spray Wiftand droplet size ClTEALL UPI is a member ofthe Spray DriftTask Own 835.4200) I'nKc



### • • •••• 

## • • 

### • • • 

## •• •• 

## • • ••• 

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### • 

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### • •• • • • 

### • •• • ••• Signature Name and Title Date

### Y.4j~tWJ..~ Bli7.abeth Anne Brown, ChemReg International, LLC 8/14/2003 Registration Agent EPA Fonn 8570-35 (9-97) Electronic and Paper versions available. Submit only Paper version. Agency Inlernal Use Copy

----- -" 

### -- ---,,--,,-"'

# ~**~ED** STATES ENVlRONMENTALP.CTION AGENCY 4OIM_S.W. WASHINGTON. D.C. 20460 Form Approved OMS No. 207().()060
PaperworkRedud:ion AdNotice: The public 

### reportingt'lUtdeii-Cor this collection of

### infOf'lU!tioniies:limaiCdiO-aVCrage 0.25 hours perresponse 

### forregistralionactiVities and 0.25 I

.. hoursper response for reregislnUion and special review activities. including time for reading the instruction and completing the necessary forms. Send comments regarding the burden estimate orany'otheraspect ofthis collection ofinformation, including suggestions for reducing the burden to: Director, OPPE Information Management Division (2137). U.S. Environmental Protection Agencv.401 M Slreet, S.W .• Washington DC**20460~** Do not send the form to this address.
Dale: August 14.2003 Applicant's/RegisLmnt's Name and Address: United Phosphorus, Inc. 423 Riverview Plar.8 Trenton, NJ 08611 Ingredient: Bifenthrin (PC 128825)

### ~ DATA MATRIX EPA Reg NoJFile Symbol 70506-18 Product: BifenlhrinTechnical InsecticidelMitieide

p'y Inc.

own

Elizabeth Anne Brown, ChemReg International. LLC Page I of4**'--.~-------------------------'**

# ~**~STATESENVIRONMENTALP.ECTI0NAGENCY** 401**MStree~S.W.** WASHINGTON. D.C. 20460 Fonn Approved OMB No. 2070·0060
Paperwork Reduction Ad Notice: The

### publiereixxtmg burden for

### thiS COlteC-lion ofinfonnalion is

### eslimakxf!claVCfage 0.25 

### hoUrs perresponse for registration activities and 0.25 I

.. hours perresponse [orreregistration and special review activities. including lime for reading lhe imilruclion and completing the necessary forms. Send comments regarding the burden estimate or anyotber aspect ofthis co1leclion ofinformation.. including. suggestions forreducing the bwden to: Director. OPPE Infonnation Management Division (2137), U.S. Environmenlal Protection A2encv.401 M SIreel, S,W•• Washington DC 20460. Do not send the form to this address.
Date: August 14.2003 Applicanl'slRcgistrant's Name·imd Address: United Phosphorus, Inc. 423 Riverview Plaz..a Trenton. NI 08611 Ingredient: Bifcnlhrin (PC 12882S)

### ~~

------_._-- DATA MATRiX EPARcg Nol File Symbol 70506-18 Product: BifenthrinTechnical InsecticidelMilicide

Elizabeth Anne Brown, ChcmRcg International, LLC Agent Page 2 of4

# ~ • NlTED STATES ENVIRONMENTAL P.ECTION AGENCY 401 M Street,s. W. WASHINGTON.D.C
_ Form Approved OMS No. 207().006()
Paperwork Reduction. Ad Notice: The public repOrting burden for this collection ofinfOrmatiori-is 

### eslimaieifiOivernge-O.25bOurs perresponse for registration activities and 0.25 boors per.response for reregistration and special review activities. inc1udill8 time for reading the inslrUction and completing the neccssruy forms. Send comments regarding the bunkmestimate orany otheraspect ofthis collection ofinformation.including suggestions forreducing the burden to: Director, OPPE Infonnation Management Division (2137), U.S. Environmental Protection NteOCY. 401 MStreet, S.W•• Washi!lgtonDC 20460. DoIlOl send the form lO thisaddrcss.
Dale: August 14,2003 Applicnnl's/RcgisU'alll's Name and Address: United Pbospborus, Inc. 423 Ri\'CfView Plaza Trenton. Nl08611 Ingredjent: Bifcnthrin (PC J28825)



### • • (D 

### VJ 

### • ••• • ••

• • 

### •• • • • Signature 

### • ••• 

### •• • • •

•• 

### •

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### •

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## • • • ••• 

# ·....



# . ., • ••• DATAMATR1X

EPA Form 8570·35 (9·97) EleCtronic and PapC:r versions available. Submit only Paper version.**--~~-----** EPA Reg No}File Symbol 70506-18 Product: Bifcnlhrin Technical InsecticidelMiticide

Name and Title EJi7.abc11l Anne Brown. ChcmRcg Internlltional. LLC Registration Agent Page3of4

Dale 8/14/2003 Public FIk Copy

# (~ AINITEDSTATESENVIRONMENTALP.ECTION AGENCY .,--' .flitM S

.....

### ~ S.W. Form ApprovcdOMB No, 2070.0060
WASmNGTON.D.C. 20460 Paperwork

### ReductIOn-Act NotiCe: 

### ThCpubllifeponing burden

### forthlsooHection-()CTDIOfiDatiOfi-iSesilili3iCdtoavcrnge-O.25 hours per response for registration activities and 0.25 bours perresponse for reregistration and special review activities,. including lime forreading the instruction and completing the necessary forms. Sendcomments regarding the burden estimate or any other aspect ofthis collection ofinfonnation. including suggestions for reducing tbe burden to: Director. OPPE Jnfonnalion Managemem Division (2137), U.S. Environmental ProteclionAIWJlCY.401 M Street. S.W••**Washin~ton** DC 20460. Do nolseDd the fonn to this address.
Date: August 14.2003 Applicanl'slRegistrant's

### Name andAddTess: United Phosphorus, Inc:, 423 Riverview Plaza Trenton. NJ 08611 Ingredient: Bifcmhrin (PC 128825)



### <.0 ,J:>. Signature 

### •• • ••• 

## •• • • 

### ••• •• 

### • • 

## • •• •• 

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## •

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### •••

### ~d'.<..u.~ DATA MATRIX

EPA Fonn 8570-35 (9-97) Electronic and Paper versions**avliiiab1e~**Submit only Paper version. EPA Reg NolFJ.Je Symbol 70506-18 Product BifcntbrinTechnical InscctieideJMiticide

Name andTille Elizabeth Anne Brown. ChcmRcg International. LLC Registration Agent Pnge4of4

Date 811412003 Public File Copy**~** •



## , "

### I i 

### ,

# .,........



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



### United Phosphorus. Inc. clo 

### Ms. Elizabeth A. Brown. Ph.D. ChemReg International, LLC 1990 Old Bridge Road, Suile 20I Lake Ridge, VA 22192-2383 Dear 

### Ms. Brown: 

## AUG 6 

# 21m

SUBJECT: Application for Registration Bifenthrin Technical InsecticidelMiticide EPA File Symhol: 70506-RJ Y<>urResubmission Dated June 11,2003 OfFICE OF PREVENTION, PEST1CIDES AND TOXIC SUBSTANCES



### The product referred to ahove 

## milbe acceplable for regislration under FIFRA sec. 3(c)(7) provided that you: I. Agree in writing to provide additional data as described below within the specified time 

### frame: You have applied for the registration ofaproduct containing the active ingredient 

### bifenthrln. The Agency bes recently conditioned the original registration ofwhich you are a follow-on with a new data requirement. This registration will also be conditioned with that data requirement. Accordingly, you must take steps to ensure that these required data are submitted. The steps could include genemting and submitting the 

### data yourself, or you may offer to share 

# til with other registrants the cost ofconducting testing. 

### The 

### data requirement which will be imposed on this regislration is as follows: Title ofStudy Guideline Reference Study No. DueDate Developmental Neurotoxicity Study 870.6300 May 1,2005 2. Submit or cite data to satisfy Guideline 

### 84-4 (Other Gchotoxic Effects). These data are required for products, such as yours, 

### with terrestrial nonfood, domestic outdoor and indoor use 

### patterns. With the exception ofthis guideline requirement, the dam you have submitted/cited and listed on the data matrix, dated 4/1112002, 

### are adequate to supportthe proposed uses.



# 95

# •

• ·2· 3. Correct the following minor typographical errors noted in the "FoodIFeed Areas" 

### paragraph on page 2 ofthe product label:
• Change "area" to "areas" near the end 

### ofthe 

### third line. • Change "example" to 

### uexamples"near the end 

### ofthe sixth line. • In

### the second to lastline, insert 

### aperiod (".") after "(mills, dairies, edible oils, syrups)" and capitalize the next word ("Serving'') to indicate the start ofanew sentence. 

### EPA Reg. No. "70506::18" is

### being reserved for this product. This must appear on the finished label. The ''Notice ofRegistration" will be issued when three (3) copies ofthe acceptable finished (printed) labels are submitted. Finished labeling is thet which will be attached to 

### or accompany the product. Refer to the attached A· 79 Enclosure. Pie
...respond within thirty 

### (30) days from the date ofthis letter stating your intentions to comply with 

### the_ informationlIabel requests cited above. If

### no resubmission is received during 

### this period, the application will be sdministratively withdrawn. This letter do•• 1IQ1

### constitute regtstrstlon. and the product may not be lawfully marketed until It is 

### registered. To expedite hlmdllng, please return acopy ofthis letterwith your finished labeling. If

### you have any questions regarding this action, please contact Susan Stanton ofmy team at (703) 305·5218.

Enclosure

# ~urs(7t7t~ George T. LaRocca**Product~anager(13)** 

### Insecticide Branch 

### Registration Division (7505C)



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## Bifenthrin Technical /' Insecticide/Miticide 

# v _ FOR FORMULATION USE ONLY/ 

### •••• • 

## • ACTIVE INGREDIENT: •••( Blfenlhrin: (2-methyl[1, 1'-blphenylj-a-yl) methyl 3·(2-chloro-3,3,3·trinuoro-1-propenyl) :.

# ··v -2,2-dimethylcyclopropanecarboxylate .•.......•.....••.••.••••••...•....•••.•..............•..•..••.•••.,............. 99

... 

### ..e . ./ OTHER INGREDIENTS

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

............................................." .•,........................**:.".~.~~:**...•.••.**~** V

. TOTAL
...............______..........................._______.............--.................................•......................•...•••...•...• 

### tOt.jl:1:V /" •••• 1 • 'Cis Isomers 97% minimum, trans Isomers 3% maximum. V •••• • • 

### KEEP OUT OF REACH OF CI::IILDREN 

# .Z::.' WARNING ./ 

### •••••• • •

•••• • •

•••• Unlled Phosphorus Inc. /' 423 Riverview Plaza 

## V Trenton, NJ 08611 EPA Reg. No. 70506- EPA Est. No. 

# / 

# .. • • 

## • ••
FIRST ,<lID Have the product container or label with you when call1ng a poison control center or doctor, or going for

• Ii, • Have person sip 

### a glass of water If able to swallow, • Do not Induce vomltlng.unless told to do so by

### a polson 

### cOl1trclcer,tero, doctor. 

## • • ca!l9t1 ambulance, than give ann,

### !c'"1f'
11 

## • •**s~n** j 1 of water for t5-20 minutes I 

### • 

## • FOR 24-HOUR EMERGENCY MEDICAL ASSISTANCE, CALL CHEMTREC 1-801l-424-93oo PRECAUnONARYSTATEMENTS 

### Hazards to Humans (and Domestic Animals) Warning /
./ .,/' May be fatal If**s~owed:** Harmful If Inhaled or s;bjOrbed througKtha skin. Causes moderate eye Irritation. Avoid breathlnl(8usl. Avoid contact with skin, et6$, or clothing. Remova contaminated clothing and wash'v--" before reuse. Wash thoroughly With soap and water atler handling and before eating, drinking, or using 

# V tobacco. 

### Environmental Hazards TIlls pesticide Is toxic to fish and aquatic Invertebrates. Do not discharge effluent containing this product /" Into lakas, streams, ponds, estuaries, oceans, or public waters unless In accordance with the requirements 

## V of a National Pollutant Discharge E1iminatlons System [NPDES) permit and the permln1ng authority has been notified in writing prior to discharge. Do not (flSCharga effluent containing this product to sewer Page 1 

# 98

### •



# • systems without previously noUfying tho sewage treatment plant

# a~~idance. contact your Stale Water Board or Regional OffIce of fhe Envlronmonlai Protection Agency. 

## V PhyslcaUChemlcal Hazards / Do not usa orstore near heat oropen flam¥. 

### DIRECTIONS FOR USE It Is aviolation of Federal Jawto use this product in a manner inconslstent with its labeling. ThIs malerlal requires further mixing before use

## ~ Only forformulation Into an

### Insectlcld~mltlclde**for~** Terrestrial Non-Food: / TermUicida and Soil Contact Nonll,PTllgatJon Treatment Wood Treatment and Protectlw Outdoor Insect Control

### V- /' Ornamental plants. trees, shrubs, and vines (WOody)"/" Residential Lawns ./ Indoor Insect ContrOl/ Non--FoodlFoed Area: May be used to manufacture end·use products lot use as a spot orcrack and crevice trealnwnt In non·fOOd areas, Similar areas where Insects hide otthrough whlch insects mayenler • .",-/ can be troated. Examples of non-food areas Include: garbage rooms, lavatOries, floor drains (to sewers), 

### V entries and vesUbules, office:J, locker rooms, machlne rooms, boiler rooms, garages. mop clOSf)ls, and storage (after canning and'botUlng). FoodIFeod Areas: MaYJl!21 b& used to manufacture products for use In loodIfeed areas. 00 not use In food areas of food handling establiShments, restaurants, or other areas where food Is commercially**prepar~** or processed. Do not use In serving areas wtlUe food is exposed orfacUlty Is In operaUon. Serving**are~re** areas wham prepared food are served such as dining rooms but excluding areas whare foods may oe prepared or held. In the home all food processlng surfsces and utensils should ba coveriringtreatment orthoroughly washed before use. Exposedfoods should be covered or removGd. Exampl of food areas are areas for receiving. storagelpackIng (canning, bornlng, wrapping, boxing)!yreparing, te wastes, storage and enclosed processing systems (mills, dairies, edible oils. syrupsl)Jerving areas (when food is exposed and faclllty Is In OperaHon) also would be conslderGd a food area. (2) Uses for Which U.S. EPA has accepted the required data andlor citation of data that the formulator has submItted In support of regtstraflon; and
• (3) Usnfor nporimen1al purposes that are In compliance with U.S. EPA requirements. Formulators using this product are responsible for obtaining U.S. EPA registration for their I ../' formulafed productwhich may be labeled forthe use pattems as found 

### listed on this label. 

### V

Page 2 

# 99**~.~**..**-~-~---~.---**



# , Storage and Disposal ,,/ Do not contaminate water, 

### food, orfeed by storage and disposal. PESTICIDE STORAGE Keep out of reach of children and animals. Siere tn original containers only. Store In a cool, dry place and avoid excess heat. Carefully open contalners. After partial use, replace lids and close tightly. Do not**P~y** concentrate or dilute matarial Into food or drink containers. Do not contaminate other pesticides, fertilizers, water, food, or

### teed by storage or disposal. In caOO of spirt, avoid contact, Isolate area, and keep out animals and unprotected persons. Confine splrtY."" PESTICIDE DISPOSAL Pesticide wastes are toxic. DO not contaminate water, food orfoed by storage or disposal. Improper**~~~** . disposal 01 excess posticlde, spray mixture, or rinsate Is aviolation to FOdera! law. Dispose of excess waste or pesticide by use according 10 tabat directions, or conlact your State Pesticide or Environmental Control Agency, or the Hazardous Waste representative at the nearest EPA RegIonal OfRce for guIdance. CONTAINER DISPOSAL /" Completely empty liner by shaking and tappIng sIdes and bottom to loosen clingIng particles. Empty leY resIdue Into application equIpment. Then dispose of liner In a sanItary landRII or by Inclneratton, If allowe 

# • by State and local authorities. Hdrum Is contaminated end cannot be reused, disposa of In the same manner.

FOR CHEMICAl EMERGENCY: Spill, leak, fire, e"Posure, or accident, calV CHEMTREC 1-800-424-9300 

# •

Page 3 

# 100•

I I '



# •

• CONDITIONS OF SALE AND LIMITATION OF WARRANTY AND LIABILITY NOTICE: Read the entire Directions for Use and Condillons of Sale and limitation ofWarranty and Uablllty before buylng or using this product. If the terms are not acceptable, return the product at once, unopened, and the purchase price will be refunded. The Directions for USB of this product should be followed carefully. It Is Impossible to efiminate all risks Inherently associated with the USB of this product. Crop Injury, Ineffectiveness, or other unintended consequences may result because of such factors as manner of use or application, weather or crop conditions, presence of other materials or other Influencing factors In the USB of the product, which are beyond the control of United Phosphorus or Seller. All such risks shall be assumed 

### by Buyer and User, and Buyer and User agree to hold United Phosphorus and Seller harmless for any claims relating to such factors. United Phosphorus warrants that this product conforms to the chemical description on the label and Is reasonably 

### fit forthe purposes stated In the Directions for Use, subject to the Inherent risks referred 

### to above, when used In accordance with directions under normal use conditions. this warranty does not extend to the use of this product contrary to label Instructions, or under abnormal condlUons or under conditions not reasonably foreseeable to or beyond the control of Seller or United Phosphorus, and Buyer and User assume the risk of any such use. UNITED PHOSPHORUS MAKES NO WARRANTIES OF MERCHANTABILITY OR OF FITNESS FOR A PARTICULAR PURPOSE NOR ANY OTHER EXPRESS OR IMPLIED WARRANTY EXCEPT AS STATED ABOVE. In no event shall United Phosphorus or Seller be liable for 

### any Incidental, consequential or special damages resulUng from the use or handling of this product. THE EXCLUSIVE REMEDY OF THE USER OR BUYER, AND THE EXCLUSIVE LIABILITY OF UNITED PHOSPHORUS AND SEllER FOR ANY AND All CLAIMS, LOSSES, INJURIES OR DAMAGES (INCLUDING CLAIMS BASED ON BREACH OF WARRANTY, CONTRACT, NEGLIGENCE, TORT, STRICT LIABILITY OR OTHERWISE) RESULTING FROM THE USE OR HANDLING OF THIS PRODUCT SHAll BE, AT THE ELECTION OF UNITED PHOSPHORUS OR SEllER, THE REPLACEMENT OF THE PRODUCT, OR COMPENSATION LIMITED TO DAMAGES NOT EXCEEDING THE FARE MARKET PURCHASE PRICE, AND SHALL NOT INCLUDE INCIDENTAL OR CONSEQUENTIAL DAMAGES

. United Phosphorus and Seller offer this product, and Buyer and User eccept It, subject to the foregoing conditions of sale and limitations of warranty and of liability, which may not be modified except by written agreement signed by the dulyauthorized representative of United Phosphorus. Pending. not EPA Approved. **03/2012002**

Page 4 

# 101

# , 

# ..

DATE OUT: July 31, 2003 SUBJECT: PROOUCT CHEMISTRY REVIEW OF Bifenthrin Technical 

### Insecticide/Miticide DP BARCODE No.: 291574 REG./File Symbol No.: 70506-RI DECISION: 219958 Linda L. Kutney, Chemist

### ~**L\~** 

# 5"1S·"" 1/'1,,1 

## 10') Product Chemistry Team '1/"1)0]1 

### FROM: Technical Review Branch/RD (750SC) TO: Marion Johnson, Susan Stanton PM-3 Insecticide Branch/ RD (750SC) 

### PC CODE: 128825 USE: Insecticide Technical Product with No associated Food Uses


### INTRODUCTION: United Phosphorus, Inc., .has .submitted product chemistry data to support their claim that their product, Bifenthrin 

### Technical Insecticide/Miticide, is similar to FMC's Bifentrhin technical, Reg. No. 279-3055. Data were submitted under MRID 46008501 and 46008502.
SUMMARY OF FINDINGS:
TRB has denied the claim of similarity between the abovementioned products 

### in previous reviews, due to differences in their reported physical chemical properties, 

### i.e., 

### density and described physical state (12/11/02 and 5/21/03 reviews).



# 102

# . .,



# •

• TRB CONCLUSIONS, According to published literature (Pesticide Manual-11th Ed., 1997), the physical state of bifenthrin varies from a viscous 

### liquid, crystalline or waxy solid, having a Specific Gravity/density of 1.210. According to the Registrant, as 

### bifenthrin is purified, it 

### becomes more crystalline and less dense, the Registrant reports that 

### it is solid above 97.St and 

### liquid 

### or waxy semi-solid below that purity. The proposed product has a nominal concentration {Ne, 1/9/03 

### CSF} of 

### 98.2 with certified limits for the cis isomer of 95.1 - 

### 100.0, with a density of 0.4593 g/ml = 

### 3.8 lb/gal. The cited product (3/22/01 CSF) had a NC of 91.1%, with certified limits for the cis isomer of 86.3 - 96.0%, with a 

### density of 1.26 g/ml = 

### 10.5 lb/gal. Because the purities of Bifenthrin varies for both the proposed product and cited product, density measurements and
. physical state descriptors are not good indicators of similarity. Because the proposed product contains no new impurities and has fewer toal impurities, TRB reverses its previous conclusion and grants the similarity request. Briefly, the results of the density tests submitted are: 

### MRID 46008501 99.26% Bifenthin Bulk Density Pour 0.452 - 0.454, avg. 0.453 g/ml 

### Tap 0.0554

- 0.558, avg. 0.556 g/ml 

### This is an acceptable study


### MRID 46008502 99.0% Bifenthin Density of Melted substance (melted completely at 70C) 1.2231,1.2085,1.2131 glml, avg. 1.2149 g/ml This is not an acceptable study, it is not acceptable to melt the sample and then determine its density.

-2- 

# 103

# •

• NOTE TO THE PM: If time permits, could you contact FMC and ask 

### if the density of their Bifenthrin technical, Reg. 279-3055 has changed since the 

### 10.5 lb/gal value (1.26 g/ml) present in box 7 of their 3/22/01 CSF? This may be a very old value that should have been updated years ago .

-3- 

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# • UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON. O.C. 20460



# JJI. I 6 2003 MEMORANDUM SUBJECT: Request for Expedited Review ...-".-, 

### FROM: Marion Johnson, Chief. 

# "f. Q 

# "t! Insecticide Branch 

## '-1'"

# ~

# "f'
TO: Regislmtion Division (7S0SC) v . 

### Deborah McColl, cruef Techniea1 Review Branch Registmtion Division (7S0SC) OFFICE OF PREVENTION, pesnCIDES AND TOXIC SUBSTANCES



### The Insecticide Branch hereby requests an expedited

### review ofadditional product chemistry dsta submitted to 

### supportregistmtion ofBifenthrin Techniea1lnseeticidelMiticide (EPA FileSymbol: 70506.RJ)
.. These data were 

### forwarded to TRBICHEM on July 8, 2003 under Data Package DP291574. 

## mrequests that the review be 

### completed within 2 weeks if possible. Thank 

### you very much for your cooperstlon in this 

### matter •



# 112

# r , 

# . ' • DP#: (291574) Doclsion #: 210958 

### DATA PACKAGE BEAN SHEET Date: 08.Jul·2003 Page 1 of3 

### '*

.. .. Registration Information· 

### '* '* Registration:**?!l~RI-** BIFENTHRIN**1ECHNICAL.INSE9:!!CID~I!!CU~§~~~**

Company:**?~**

### -**UN~I1J§~_ PHOSPHORU~!4.c**  Risk Manager: RM 03
- Marion
- Johnson
- (703)**3O~188** Room# CM·2 219 Risk Manager**Rev~r:** SUIDn" Stanton
- SSTANTON Calculate<! Due Dale: 08-0ct·2002 Typo of Reglalrallon: Product Registration' Seetlon 3 AcUon Dose:**NEW,RE~~~:rftATION;OLD INGREDlE~~IN0B._~~GE;** 

Ingrodlenll:**128~t_ ~**  ,.__, __**,.~** __**~**______**~**______ 

# • • • • Data Package Information· •• Expedito: : Yes • NoDP Ingredient**!~~~~, 8~ntl!rin**  ___ '_______
CSF Included:
.. YOI No labellncludcd: • YOIl No Parnnt DP #:
Date In Date Out edited Duo Dalo:

Due Blick:

Organlzallon:**~E_~:rRB** 

### _ ToomNamo; Admlnlltralive Due Dale: Q5.0ec-2003**~-------~** Negollated Due Dalo: Roviewer Name:

ATTN: Shyam Mathur Projected Compltluon 01110:



### • •• Studies Sentfor Review· •• Prlnled on Pllgo 2



### * * *Additional Data Package for this Decision· 

### * * PrInted on Page 3



### •• • Data Package Instructions· ••
In LInda KUlney's May 20. 2003 review, she determined \hat United Phosphorus's new bifonlhrln 1echnlcal was nol subslanllally similar 10 FMC's registered hlfenthrln technical, In part because of dl/fllr&nces In density between the two products. IdllCUSscd this wllh you and you suggested thai tho company develop additional dOn$ily data, perhaps using a different method, Thoy have dono so and submitted it along with tin oxplanotlon of tho density of blfonlhtln In 

# 113**~.~** 1-**~Iatlon** t;lrs purity and physIcal slale. PIQllse rovlaw the new dllia (MRlDfIs 460085-01 and 460085-02) lind 101 us know wheihorihe new InformaUon supports the delermlnatlon thal tho product Is substantially similar to FMC's technical. Thanks, Sunn Stanton



# •

•

114I 

### ., , 

# .

285142 285143 285143 288051 **288051**


# •

• PIIgo30f3

RD/TRB 08-.lul-2oo3 08-.1u1-2oo3 RO/IB OihIu1-2003 08-Jul·2003 RDITRB Oa-Jul-2003 O/NuI-2003 RD/IB oa.Ju1-2003 OS-Ju1-2003**.-«~«-.----------**

.. Yea 

### 0 No • Yos -:' No

.. Yes 

### No 

### Et Yea (-' No • Ye, ,) No 

### ., Yes<J No ,-'. Yes**,~\** No --'**.~** • Yos 

## :-1 No • Yes 

# =, No ':' Vcs--=:!No • Ycs<:"\ No • Yes 

### No



# 115

# • • 

# .. \



# •

• Elizabeth: George laRocca 07/161200303:37 PM To: Elizabeth Brown <brown@chemreg,com> cc: "TIllman Ann (E-maUt <atlllman@upJ...usa.com>, Debbie EdwardsJDCIUSEPAlUS@EPA,Marfon JohnsonlOCIUSEPNUS@EPA, Susan StanlonIDCIUSEPNUS@EPA Subject Re: request for urgent meeting ro pending application EPA File Symbol 705Q6.RII1l

t don't believe a meeting is necessary at this time. Based upon the chronology ofevents associated with this apprlCstion for regIstration and the one remaIning Issue about physIcal state and density I will request an expedited revlew(2 to 3weeks) ofthe addlt/onallnformation you recently provided. Ifthere are stili questions associated with thIs issue at that time that cannot be easily resolved then I will schedule a meeting with you and UP!. George laRocca Elizabeth Brown <brown@chemreg.com>



### George: Elizabeth Brown <brown@Chemrog,com > 07/11103 12:33 PM To: George LaRoccaJDCIUSEPNUS@EPA cc: Susan StantonIDCIUSEPAlUS@EPA,Marion JohnsonIDC/USEPAlUS@EPA, DebbIe EdwardsJOC/USEPMJS@EPA, "TIllman Ann**(E-mall)~** <atJllman@upl.usa,com> Subject: request for urgent meeting re pending application EPA File Symbol 70506-RI



### On behalfofour client, United Phosphorus Inc" I am requesting a meeting as quickly as possible to discuss and address current issues regarding the above application for registration of Bifenthrin Technica1. We request the 

### attendance ofyourself, Susan Stanton, Marion Johnson, Debra Edwards, and the appropriate chemists, We requesfthat 

### a meeting 

### be held any time the 

### week ofJuly 21. Dr. Ann 

### Tillman (UP!) and ! (representing UP!) will attend. The reason for this request is that on July 8,2003, Susan Stanton informed me that UPl's explanation to a verbal question raised by the chemist was being routed for full review, with 

### a 

### due date forresponse from Chemistry in

### December 2003. We feel that this is entirely unnecessary and 

### is another unreasonable delay in 

### the consideration ofUPl's application. Given the question and UPI's response, we believe that the issue can and should be quickly resolved. As you know, UPI filed an appJication for registration ofBifenthrin Technical on 4/8/02. 

### On 4125102, 

### the Agency sent a letter stating that the application was considered incomplete because 

### EPA Fonn 8570-34 (Certification with Respect to Citation ofData) was not included. Following our letter to the Agency of5/8/02 

### and the Agency's letter in response on 6/3/02, 

### along with other 

### meetings on the issue ofthe timing offiling ofthat form, the Agency in its letter of8/14/02 confirmed that EPA Form 8570-34 is not required in order for the Agency to begin reviewing the 

### application. However, to ensure no further issues, UP! submitted EPA Fonn 8570-1 on 8129/02._ But the actions by the Agency 

### resulted in a 4 month delay in starting

### review ofUPl's application,



# 116

## • . 

# ,



# • On December 16, 2002, UPI received the Agency's Product Chemistry Review ofthe 

### application 

### (DP Barcode D285 142, dated 12111102). In that review, the Agency determined that additional physical/chemical characteristics data needed to be provided. Other issues identified in that review were resolved by phone discussions with 

### the Agency. 

### On Janunry 15,2003, UPI submitted all additionally required product chemistry data, with the exception ofthe 

### I-year storage stability study. requesting that submission ofthe 

### fmal report be a 

### condition ofregistration. 

### We confirmed that the study was underway and committed to providing it. On 411

### 012003, I talked with Susan Stanton to determine whether the O-day report should be 

### submitted; she said 

### it should not be submitted but to wait for the 

### final report which would be 

### a condition 

### ofregistration. She also identified that Chemistry reviews were due back in 

### early May. UPI thus has fulfilled aU 

### product chemistry data requirements on its technical material with its own studies, with the exception 

### ofthose data requirements where the PAl is the test material and long term stability (which would be a condition ofregistration). 

### The Agency has confirmed the UPI can cite and offer to pay data compensation for those data requirements. which UPI has done. 

### On May 23, 2003, Susan Stanton called me to ask whether we could explain why uprstechnical (98.2% purity) was a solid (crystalline powder) while tl,e FMC technical (previously 89%, now 94%) is aviscous liquid. I explained 

### that the physical state changes 

### with the purity. On June 4. 2003. Susan Stanton again called, identifying that the chemist still is having trouble with the different densities ofUPJls and FMC's technical materials. She asked that we provide an explanation andlor new study using a differentmethod that showed the same density for the UPI material as for FMC's as quickly as possible. and said that the study did not need to be glp. She said that providing that information would allow the chemist to quickly complete his review.


### • On June 9, 2003, I called Susan Stanton to let her know that I) the difference in density and physical state is due to well-known and well-documented association with purity 

### ofthe material 

### which we could provide in letter forni, 2) that UPI had confirmatory data to document that the density value already submitted and reviewed is correct. She asked that both be 

### submitted, with 

### a full copy ofthe confinnatory reports given to her as well as submitted through front-end processing,just to speed the process. She indicated that there should be 

### very little delay to review the explanation. The explanatory letter and confirmatory data were submitted and 

### hand-delivered on June II, 2003. As indicated above, on July 8, 2003, Susan Stanton called to let me know that it will 

### be another 5..6 months before the Agency can review awritten explanation ofawell-known and 

### documented effect of purity on physical state and density. The confirmatory data do not change or replace the already reviewed study for density ofUPI's Bifenthrin technical; those data only confirm the results and explain how changing the physical state ofUPI's material can change the density. consistent 

### with the explanation provided, in relation to FMC's product.


# 117

# · .'



# •

• Those confirmatory data are not required to supPOrt 

### registration and would not have been submitted without the Agency's assurance that there would not be 

### a delay in 

### review ofthe pending application. The explanation provided in letter fonn is adequate to address the chemist's questions and 

### will not require a detailed review. We believe that adelay ofan additional 5-6 months, combined with the earlier 4 month delay. 

### are unfair to United Phosphorus. We have very much appreciated the Agency's willingness to discuss and quickly resolve other issues and believe. that this issue a1so can be 

### readily and quickly resolved. Please let me know when the requested meeting has been arranged. Regards, 

### Elizabeth Brown

**Elizabeth Anna**  **Brown, Ph.D.**  **ChemReg Intemational**  1990 Old Bridge Road. Suite 201 Leke Rktge, VA 22192 Phone: 703-492-7905 Fax: 703-492-0668 **Email: brown@chsmrag.com** 



# 118

# ,. •



# • •

## \\OS~**SS",<:,,,~** UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D.C. 20460


### July I, 2003 OFFlCEOF PREVENTION, PESTICIDES AND TOXIC SUBSTANCES 

### JEFFREY PRITCHARD ' UNITED PHOSPHORUS lNC 423 RIVERVIEW PLAZA TRENTON, NJ 08611 Report ofAnalysis for Compliance with PR Notice 86·5 Thank you for your submittal ofII-JUN-03. Our staffhas completed a preliminary 

### analysis ofthe 

### material. The results are provided as follows: Your submittal was found to be in full compliance with the standards for submission of data contained in PRNotice 86-5. A copyofyour 

### bibliography is enclosed, annotated with Master Record IO's (MRIDs) assigned to each document submitted. Please use these numbers in all future 'references to 

### these documents. Thank you for your cooperation. 

### Tryou have any questions concerning this data submission, please raise them with the cognizant Product Manager, to whom the data have been released.



# 119

# r



# • 1990 OLD BRIDGE ROAD, SUITE aOl LAKE RIDGE, VIRGINIA 22192w2383 Dmncr: 703w492w7905 MAIN: 703-492-0445 Fax: '703·492·0668 £OMAn.: brown@chemreg.com



### ELIZABEl'HA. BROWN, PH.D. June 11,2003 Document Processing Desk 

### U.S. Environmental Protection Agency (7S0SC) 

### U.S. Environmental Protection Agency 

### Room 266A. Crystal Mall 2 1921 Jefferson Davis Highway Arlington. VA 22202-4501 Attn: George LaRocca (pM 13) W1m SITES: www.chemreg.com www.pesticlde.net

" ,

# ., 

# .. , "



# ..

, 

# .**~~**

# .......

, r • , 

## " 

# .

. " 

# . Re: Bifenthrin TechnicallnsecticidelMiticide (EPA File Symbol 70S06-RI) 

### Response to Agency phone call 

### ofJune 4 and S, 2003 

### Dear George: On behalfofour c1ien4 United Phosphorus, Inc., this letteris in 

### response to 

### phone discussions ofJune 

### 4 and 5,2003, with Susan Stanton, where she requested clarification 

### regarding the density ofthe UP! bifenthrin technical (EPA File SymboI70506-RI) in comparison to what is reported in the open literature and on file with EPA for the aIready registered technical 

### • grade bifenthrin under EPA Reg. No. 279-30SS. 

### Bifenthrin technical can exist as avery viscous liquid, awaxy solid, or as a crystalline 

### powder (solid). depending upon the purity ofthe technical grade material (as identified in WHO specifications, Pesticide Manunllllh Eel, 

### copies attached). As part 

### ofnormal manufacturing processes. a

### lower grade, crude product is obtained and subjected to 

### purification steps before the 

### final technical grade material is obtained. The extent ofthe furtherputifieation and any crystallization steps will determine the appearance and density ofthe final technical material. Oily impurities remaining 

### in the 

### technical product contribute to the appearance 

### ofthe 

### final fonn. 

### There always is a purity intelJlhnse between physical nppearance from solid to viscous liquid, which is about 97.S% 

### for Bifenthin. Above**tha~** 

### the technical bifenthin is solid, below that it becomes avery viscous liquid, with the waxy semi·solid form intermediate.

CONSULTANTS TOSUCCESS'" Over 

### Onc Hundred andFiftyYcars ofCombinedExperienceAssistingChemical, Pesticide, 

### Bio·Chemica1 and

### Ufe Science Companies on 

### aWide Range ofIssues, 

### Including Regujnto,Q'"", Strategies, Registration, Data Supportand Compensation, QualityAssurance, StudyDc1il!U and

### Scientific Matters.r



# •



# • --**~~-~~~~~-------**

Leuer to G. LaRocca. June 11. 2003, page 2 

### The final appearance (fonn) ofthe technical material also has a direct heming upon the density ofthe technical. Liquids have a higher density than crystalline powders, with waxy solids intennediate between the two. 

### The purity ofthe UPI bifenthrin technical is (nominal) 98.2%. It is a crystalline powder. The density ofthat technical material is 0.4593 gfml at 27"C, as determined in accordance with OECD Method 109 and CIPAC MT 3.2 "Pycnometermethod" (MRID 

### 45838001, in JRF 

### Study No. 2736). Those methods in accordance with OPPTS 830.7300 (June 2002). The validity of those data is confmned by the enclosed supplementary study conducted at Product Safety Labs (pSL Study No. 13107), in which the pour density was detennined to 

### he 0.453 gfml and the tap density as 0.556 gfml (OPPTS 830.7300, August 1996). The currently registered Bifenthrin Technical under EPA Reg. No. 279-3055 is 94.0% (nominal) purity. At tlmt purity level and at the originaliy registered 89.0% purity (until June 2001), that bifenthrin technical material would he a viscous liquid at 89.0% and a waxy solid/semi-liquid material at 94.0%. The density vaJue for bifenthrin technical as reported in 

### multiple places in the public literature as 1.212 gfmlat 25'C, appears to

### he associated with the lower purity material, which is aviscous liquid. For example, The Pesticide Manual (11 tit 

### Ed.) reports the specific gravity/density as 1.21 glml. based on older information, as does 

### EXTOXNET (based on the 1988 EPA Fact Sheet No. 177). As 

### a liquid or 

### as a waxy material, the density ofthese lowerpurity technical grade bifenthrin products is expected to he higher than that ofthe high purity UPI product, which is a crystalline powder (solid). This 

### is confinned by the enclosed study (JRF Study No. 4176), in which the high purity crystalline powder was melted and then detennined the density ofthe melted and solidified material according to 

### appropriate testing metllOds. The density ofthe melted, solidified high purity UP! material was found to be 1.2149 gfml at 20'C. This value may he more appropriately considered as the specific gravity, which for water in the liquid state is 1.000 gfml
. Thus, the differences in the density is determined by the physical state o.ftbe materials, 

### which in tum is determined by the purity. The correct value for the density ofthe UPI bifenthrin technical is 0.4593 gfml, for the material as produced (as identified in MRID 45838001). However, the enclosed confirmatory results demonstrate that the density/specific gravity ofthe product is comparable to the reported literature values when the crystalline nature ofthe UPI material is modified to the solid form. We also note, in 

### response to prior Agency comments that the nominal value for the UPI 

### material is outside the cenified Iimlts for EPA Reg. No. 279-3055, that the Agency recently approved a 98.65% purity technical bifenthrin (under EPA Reg. No. 51036-390, approval date 2/2/03). The nominal for UPI material is 

### within the certified Iimlts for the latterproduct, which the Agency deemed substantially similar to the fonner. As 

### such, and given the enclosed explanation. the Agency should have all 

### infonnation needed to 

### approve the UPI application for registration.


# 121

# . . •



# •



# • •

Letter to G. LaRocca. June 11,2003, page 3 There have been significant delays in 

### the Agency's review ofthis 

### application, although the registrant has responded very rapidly to any questions or requests. We therefore Iequest that the enclosed infonnation be 

### reviewed on aprioritized and rapidbasis. 

### Enclosed with this letterplease find EPA Fonn 8570·1, transmittal bibliography, and three copies ofeach submitted study. 

### Regards,

Elizabeth Anne Brown Attachments to letter: 1. 

### Interim specification: WHOlISffCl41512001. TechnicalBifenthrin 2. The PesticideManual, 11" Edition, 1997. Entry 

### for Bifenthrin
cc: United Phosphorus,lnc
.



# 122•



# • TRANSNUTTALDOCUMENT Submitter 

### United Phosphorus, Inc.

423 Riverview PJaza 

### Trenton. NJ 08611 

### Regulatory action in SUpPOrt ofwhich this paclqlgc is submitted New Product Registration ("Me-Too', (Bifenthrin Technical InsecticidelMiticide 70506-RI) 

### Trnm;mil1l!' Dnlc

June 

### II. 2003 SybnJi!led Stydj

.. 

### MRID



### . Administrative Materials Document 1: 

# %OO£,SGI Wo, C. 2003.- Bifentbrin Technical. Physical and Chemical Characteristics: Density. Unpublished report submitted by United Phosphorus. Inc. PSL Study No. 13107. 10 pages. Document 2

# ~~OOS50). Vohra. Y. 2001. Density ofBifenthrin. Unpublished report submined by United Phosphorus, Inc. JRF 

### Study No. 4176. 15 pages. Company Official 

# Y.t.j

..........**~~** Company Name: ChemReg International, LLC., Authorized Representative for UP! Company Contnct: EJizabeth Anne Brown Phone Number: 703492-7905



# 123

# .oEPA UnIted States 

### Environmental Protection Agency Amendment Other

ChOCk "this Is a nBWaddress EPA Rog No. Producl Name

NoUf\ca1lon
- ExplaIn below Aoencv loHor dalod 

# D "Me Too· Application response 10**~** Other- Explain below
Supplementary Information In responso 10 Agency phono calls ofJuno 4. 5. 2003

No**'O."'rnc~a,on** 

### must bosubmlnod 

# """"

".""','"Anne Brown No

COnlnlnor

I urtU'y thut the staltm!lntS I bavemade on thI.!i thereto are true, lIecurlte and complete. I acknowledge talseormWead1ng stalemtntllUlJ be punlslulble by fine or lmprlsonmen1 or**C~~~~~lnlemaliOnall** UC A Agenl

Elizabeth Anne Brown Juno 11, 2003 None 

# 0 Rostricted



# ""tic G""" Paper Other (Spoc!fy)
__ _

(Stamped)



# 124

# •

• l/ihU/"n<nC 1. WHOIlSfTc/41SI2001 BtFENTHIN TECHNICAL



### 1. 1.1

1.2 

# TECHNICAL BIFENTHRIN

tnlerim llpecificalion: WHonsrrCf4t512001 

### Specification nmripHon The material shall consist of homogeneous mixture of technical bifenthrin together with 

### some re ted manufacturin
. t shall be in a fonn ofa light brown to am viscous 

### liqUi ,c wHine 

### solid or wax solid 'th n very faint slightly sweet odor. free rom VIsible extraneous matter and added modifying agents. Chemical and physical requirements The materia] sampled I from any part ofthe consignment, (see method WHO/MIl.R 1)1 slmll comply with the requirements of section 1.1 and with the following requirements.
. 12.1 

### Identity test Where the identity of the active ingredient is in doubt, then it shall comply with at 

### least one additional test (eIP 

### AC method 4lSffClMl2). 1.2.2 Bifellthrin COlltenl (glkg basis) The bifenthrin content shail be declared (nolless than 920 glkg) and, when determined by the method described in section 2.1. the mean measured content shall not be lower than the declared content. 

### 1.2.3 Acidity The acidity ofthe material, when detennined by the CIPAC method MT 31 (CIPAC 

### Handbook

### F. p.96). shall not be 

### higher than 4.0 glkg calculated as H,S04. 1.2.4 Water content The water content determined by the method described in WHOfMJ7.Rl (equivalent to CIPAC method MT 30.5. CIPAC Handbook J, p.(20). shaH not be 

### higher than 2.0 

### glkg.

! Berore sampling heallhc contents orthecontainer 10 aboul 80°C 10 mellllny crystallized :tClive ingredient, and homogenize by appropriale shaking. P'gol

## orl4 

# 125

# •

• WHOIlSffC/4 tS!200t BtFENTHlN TECHNtCAL 1.3 Packing and marking ofpackages The technical bifenthrin shall be packed in suitable clean containers, as specified in the order. AU packages sbrul bear, durably and legibly marked on the container, the following: Manufudurer's name Technical bircnthrin Balch orrererence nwnberand dateortest Net weightorcontenlll Due ormanufilctun: and the following minimum cautionary notice: Bircnthrin Is II pyn:throld that act!predombanlly on lhe centrat netWW system; hlg.b dosugts have be<!n found 10 cause tnlmor and clonic C(JIlvuhinns in expttimentat anillllll5. A hig.h concentralion in air 11'11)' be irrillint 10 tlU! eyes and contact whb the conccntnued prodUCI may induce II lemporary lingling stns.Jlion, particulDrly on the race. II mIlY be hnanIow; irswallowed.. Do not inhale spmy mi$l. Avoid skin COlltaCt: wtar proleclive 810\'1:$. dun pmlecCivr: tlothlng. and II race nwk (swgical type) wUen handling the product. WIUh h:ux.lJ and Cl:posed skin thorouahtyaflCfusing. Keep containena:oul orreach orchildren and well away rrom fucxUtulTs arnhnitnlll rcOO andthcircontalners. Irpolroning occun. call aphysician. Trealmcnt is symptomatic. BlrenLluin b toxic 10 lIqUllt1C wildlire. A
...oid accidental contamilwlon orwattr. 

### 2. Methods ofdetermlnlng chemical and physical properties 2.1 Blfentbrln content 

### 2.1.1 Outlineofmethod This test method describes the analysis oftechnical bifenthrin and several of its formu1ations. Improved column technology and method optimization have yielded a method which give resu1ts equivalent or superior to previous methods
. Bifenthrin is determined by comparison to an internal standard, octacosane. A test solution containing a mown concentration ofoctacosane is utilized by comparing instrument response (peak area) ofthe intemru standard to the relative response of bifentbrin, taking into account the amount ofsample being analyzed. 2.1.2 

### Apparatus AnalyticalBolance. Capable ofaccurately weighing to 0.1 rng or equivalent. 

### Centrljilge. GO$ 

### Chromarograph. Capable of operating over the range 100 to 300°C, fitted with a flame ionization detector and data collection system and if possible an autosampler. 

### Graduated Cylinder. 500 

### mL. ReciprocatingShaker. V"lOls, Minimum 40 mL capacity, with poly-lined cap. 

### Volumetric Pi petre.
Page20fj/

## 4- 

# 126

# ,,' .,



# •

• WHOlIsrrC/4ISI200t Magnelic Slirrerandstirbar. BIFENTHIN TECHNICAL

Column. Megabore DB-210, 30 meter length, 0.53 nun internal diameter, film thickness 1

### pm; maximum temperature (isothermal) 200 °C. Available from J&W Scientific, orequivalent. 2.1.3 Reagents Oclacosatte. Eastman Kodak Chemical Co or equivalent. 

### Heptane. Acetone. Difenrltrln, Analytical Standard Grade, available from FMC Corporation, Agricultural Chemical Group. Princeton, NJ, USA. 2.1.4 Analylical instrument parameters Gas Chromatograph parameters (all conditions may be adjusted to optimize results): Oven Temperature: Injection Port Terpperature: 

### Detector Temperature: 205°C 240°C 300°C Data StationParameters: (all parameters may be modified to optimize results): RunTime: Chart Speed: 

### Zero: 2.1.5 Determlnah'oll a/response/aclor JlRF' 

### Sminutes 0.5 

### cmlmin 5% full scale
Weigh 0.1 g afthe analytical standard, to the nearest O.OOlg, and place into a vial. Prepare an internal standard stock solution by weighting 2.5 g octacosane, to the nearest 0.01 g. and placing it into II bottle with a capacity ofat least 1000 

### mL. To this add 700 mL ofheptnne and 175 

### mL ofacetone, which have been measured by a graduated cylinder. Mix well using a magnetic stirrer. Pipette 40 mL of the internal standard stock solution to the via] containing the annlyticalstandard; 

### mix on reciprocating shaker until dissolved. Inject 1

### J.1l. ofthe standard solution into the gas chromatograph. Obtain several chromatograms and measure the peak areas ofthe internal standard and bifenthrin. Calculate response factor by the following fonnula:

Page 3

# of;4 

# 127

# ,



# •



# • WHO/JSITC/41SI200J


### Where:

2.1.6 

### A.**~** Area internal standard A..,**~** 

### Area bifenlhrin WT""**~** Weight ofstandard WTis**~** 

### Weight ofinternal 

### standard P""**~** Purity ofbifenthrin standard 

### p.**~** Purity 

### ofintemnl standard Samplepreparation DJFENTHIN TECHNICAL

B/fent/lrln teclJnical. weight 0.1 g into n vial. Add 40 mL of internal standard 

### stock solution and mix on reciprocating shaker until dissolved. Inject 1J.lL portions ofthe sample solutions, obJaining three replicate injections for each. Run a standard iqjection series after every three or four samples. CalculnJe percent (%) active ingredient bifcnthrin by the follo.wing formula:

Where:**~A"'.""'-'X'i:-:'"::rr","'.:.:;;X'-'.R::.P_X::...:'::0,,-O** 

# , 

# . Ab Xl'.l'lIpl

= .Area ofbifenthrin in sample = Internal standard weight = 

### Response Factor 

## = Area ofinternal standard peak = Sample weight

Page 4 ofJlI

# 128

### , , 

### ,



# •



# •

BRITISH CROP PROTECTION COUNCIL


# 1'197 129.' 

### •



# •

• bifenthrin Insecticide, llCllri,-it/, pyrethrold

(Z)-(IS)-cI

.. NOMENCLATURE Common name blfenthrin (SSI. ANSI, draft E·ISO); blfenthrine 

## «(f) draft F-ISO} IUPAC name**2-m.thylblph.n~-3-ylm.th~** (Z)-(1 RS.3RS)-3-(2-,hloro-= 3.3.3-trlfluoroprop-1-enyij-2.2-dlmemylcyclopropanecarboxylate **Ro.fh:** 2.methylblphenyl.3-ylmethy' (Z)·(1RS)·ds-3-(2-chloro-3.3.3-trlfluoroprop-=**~** 1-enyl)-2.2-dlmethylcyclopropanecarboxylate ' 

### Chemlal Abstrac:ts name**(2-m.th~[I.I·-blph,"yI1-3-yl)m.thyl** 3-(2-,hloro-= 3.3,3-trlfluoro-1-propenyl)-2.2-dlmethylcyc!opropanecarooxylate eN; RN [82657-04-3] Development ,od
.. FMC 54 

## eoo OfIIclai ,od
.. OMS 3024 PHYSICAL CHEMISTRY Composition Material contains

### ~97%~.~"~·'-~1~~~ Mol. WI. 422.9 M.f. c"H"CIF,O::. 

### .:!§iiDM.p. 51-66'C V.p_ 0.024

(25 0c) SolubilIty In water, 0.1 mg/l. acetone, ,hl,orolonn. dJchloromemano. dIemyl ether, and toluene. Slightly soluble In heptane and methanol. Stab!11ty Stable for 2

### yat 2S DC and 50 DC (tech.), In natural daylight DTso 255 d, stable 21 d at pH 5-9 (21°C). F.p.165"C (Tag open cup); 151 "C (Pensky Martens closed cup) COMMERCIAUSATION History Insecticide and acaricide reported by H. j. H. Doel et 01. (Meded. Foe. Landbauwwet Rqksunlv. Gent., 1984. 49. 929) and A. R. Crossman et al. (ibid .• p. 939). Introduced by FMC Corp. Manufacturers FMC
f fR hrrt!nti1rfn


# 130

# ... DP BARCODE, D288051 CASE, 072204 SUBMISSION, S628277 DATA PACKAGE RECORD BEAN SHEET DATE, 01/29/03 page 1 

### of 1



### CASE TYPE, RANKING 

### CHEMICALS, 

## * * * CASE/SUBMISSION INFORMATION 

### * 

## * * REGISTRATION 10 POINTS () 128825 Bifenthrin 

### ACTION, 166 RESB NEW PRO-OC-MIN CHG (ANSI) ID#, 070506-RI BIFENTHRIN TECHNICAL INSECTICIDE/MITICIDE

.COMPANY, 070506 UNITED PHOSPHORUS INC 99.4DOO%'



### PRODUCT MANAGER, 03 ARNOLD LAYNE 703-305-6249 ROOM, CM2 212 PM TEAM REVIEWER, SUSAN STANTON 703-305-5218 ROOM, CM2 237 RECEIVED DATE, 01/15/03 DUE OUT DATE, 07/14/03 

## * * * DATA PACKAGE INFORMATION 

### * 

## * 

## * DP BARCODE, 288051 EXPEDITE, N DATE SENT, 01/29/03 DATE RET. , 

### !**·~EMlCAL:** 128825 Bifenthrin (ANSI) TYPE: 001**Submi~sion** Related Data Package**S'-~** 

## -<U CSF, Y LABEL, Y ASSIGNED TO DATE IN DATE OUT ADMIN DUE DATE, Go6/1S/o3



### DIV 

# , BRlIN, SECT, REVR 

# , CONTR, 

# • RD 

### / / ! 

### / NEGOT DATE: 

### / TRB 

### / / ! 

### / PROJ DATE, 

### ! CHEM 

### / / / / / / / / / / / / 

## * * 

## * DATA REVIEW INSTRUCTIONS 

## * * * Attn: Resubmission**in.~esponse** to Linda Kutney's 12/12/02 

### review (D285142) On behalf of United phosphorus, ChemReg has submitted additional data/information and a corrected CSF to address 

### deficiencies noted in Lindals original 

### review. Please review the company's response, including the new CSF and data (MRID#458380-01), and determine whether 

### it adequately addresses TRE's concerns. Copies of the cover letter, data and CSF are attached, along with TRB's original review and the company's original product chemistry submission (for reference.) . If you need anything else, please give me a call. Thanks, Susan Stanton 

## * 

## * * DATA PACKAGE EVALUATION 

### * * 

### * No evaluation is written for this data package



## * * 

## * ADDITIONAL DATA PACKAGES FOR THIS SUBMISSION 

## * * * ! ! 

### /

DP BC BRlINCH/SECTION DATE OUT DUE BACK INS CSF LABEL 

# 131

### · 

# .



# •



# • DATE: SUBJECT: FROM:

TO:
DPBARCODE: EPA REG. NO.: 

### REGISTRANT: USE: 

### INTRODUCTION: May 20, 2003 Product ChemislIy Review ofBifenthrin Teclmical Linda 

### L. Kutney

## ~L-~ ",,,-'/o:!> Product Chemistry Team 

### Technical Review Bmnch/RD (7505C) Cynthia Giles-Parker, Susan Stanton PM 3 Insecticide Branch! RD (7505C) 0288051 70506-RJ United Phosphorus, Inc. 

### Insecticide

United Phosphorus, Inc. has submitted additional product chemislIy data to support the registration of "Bifenthrin Technical. InsecticideIMiticide1> in response to TRB's **12111/02** 

### review, 0285142. The revised proposed basic CSF.is dated 1/9/03. 

### This proposed label is for inseciticidelmiticide non-food use. including as a tenniticide and soil contact nonfumigation treatment. as wood treatment and protection, as outdoor insect control. on ornamental plants. trees, shrubs and woody vines, residentiaJ lawns and for indoor insect control., spot or crack and crevice treatment in non-food areas. Use in 

### food or feed areas . is prohibited. The product chemislIy data has been submitted under 45838001 and previously under MRlDs 45654401, 45654402 and 45654403. In their letter of418/02, United Phosphorus claimed similarity to FMC's Bifenthrin Technical. Reg. No. 279-3055, containing 94.0% ofBifenthrin ai, and a minimum of97% cis 

### isomers and a maximum of3% oftrans 

### isomers. as listed on the label accepted 6/21/01. No minimum oftmns Bifenthrin isomers was included on the approved label.

-1- 

# 132 '------------------------------

### · 

# .



# •

• SUMMARY 

### OF FINDINGS: 

### I. The description ofmaterials used 

### to produce the product satisfies tl,e data requirements of" guidaline 830.1600 (40CFR§ 158.160). 2. The deseription of production process satisfies the data requirements ofguideline referenS!' 830.1620 (40CFR§158.162). 

### 3. The discussion on the fonnation ofimpurities 

### satisfies the data requirements ofguidelinev 

### reference 830.1670 (40CFR§ 158.167). 4. Datarequirements for oxidation-reduction, flammability, explodability ,pH, melting point, 

### boiling point, density, and dissociation constant now satisfY the data requirements ofguideline,,/ references 830.6314, 830.6315,830.6316,830.7000, 830.7200,830.7220, 830.7300, and 830.7370, respectively. 5. The density and pH 

### ore now included in blocks 7 and 8 ofthe revised CSF, in agreement with" the study results, as required 6. The "non-applicable" flash point given in block 9 ofthe CSF is now supported by study ./ results, as required. 

### 7. The chemical name for bifenthrin is now included in column 10 ofthe 

### CSF. as required. v 

### 8. 

### The minimum and maximums listed in column )0 for cis and trans isomers ofbifenthrin correspond to the fractions ortOlal bifenthrin. The minimum amount ofcis isomer given in ,/ column 14b and 

## the maximum vruue 

### oftrans 

### isomer given in column 14a 

### ofthe CSF are 

### calculated correctly. 9. The AoaIyticai Method (guideline reference 830.1800, 40CFRI58.180) indicates that cis and' trans bifenthrin is adequately separated and quantitated 10.The Registrant has agreed that samples will be 

### submitted to the Agency laboratory upon 

### v registration ofthe 

### product Guideline 830.1900, (40CFRI58.190) is satisfied.

-2- 

# 133

# ..

CONCLUSION:
TRB has determined that Bifenthrin TechnicallnsecticidelMiticide is not substantially similarto 

### FMC's Bifenthrin Technical, Reg. No. 279-3055, from aphysical chemistry standpoint due partly to the fact that it has a density of3.83lblgaL as opposed to 10.5lblgal for FMC's Bifenthrin Technical, Reg. No.279-3055. In addition the minimum concentration ofthe active cis portion ofBifenthrin does not fall between the UCL and LCL for the cited, registered product. The proposed CSF, dated 218102 is acceptable with the comment we recommend column 10 ofthe CSF be 

### revised to list the pnrenthetical expressions as follows:

# ~that the cis isomer include the statement '97% minimum oftotal Bifenthrin' and the 

## t5r

# ~f: 

# fit**~trans** isomer include the statement "3% maximwn oftotal Bifenthrin' for additional clarity. 

# 1-;- 1\/13 For full registration, United Phosphorus must submit the following SubgroupB physical 

# ;;/,76 chemical studies (See 40CFR Section 190):


# • STUDY: Stomge stability Corrosion Characteristics The follOWing

### product chemistryrequiremenIs are stillnotsatisfied: Par/ilion 

### coeffiCient**(n~octlwater}shake** 

### flask method Waler 

### Solubility column elution method, shake flask me/bod 

### Solubility in organic **so/venls**

-3- GUIDELINE 

### REFERENCE #: 

### 830.6317 830.6320
830.7550 830.7840



# 134

### BARCODE:D28SJ42;Reg. No. 

### 7QSQ6·RI PRODUCT: 

### Biron/brin Iech.lnsecticidelMiticide 830,1550, Product Identity: CommonName: Bifenthrin Technical 

### Chemical Name: "(2·methyl[1,1'·biphenylj.3.yl)meU,yl-3-(2-chloro-3,3,3.trifluoro·lpropenyl)-2;2-dimethylcyclopropenecarboxylate," CAS No.: 82657·04-3 for cis isomer, 83322-02-3 for Imns isomer PC Code No,: 128825Jor cis ondtrons mix 

### Empirical fonnula: C23 H22 CI F3 02
• MolecularWeight: 422.9 giMole



# • Structurnl fonnula and additional product identity data (from MRID 456544-01)

• 'JGI<le 1'1...... : M"""'ulnr """""t.o., Mole""h'" W .. ll;h"**!i""~** 

### ..und l'.........a,



# 135

### BARCODE:D285142;Reg. No. 70506=Rl PRODUCT: Bifenthrin 

### Tech.lnsecticideIMiticide REVIEW OF PRODUCT CHEMISTRY, OPPTS 830 SERIES

Table 1: 

### Manufacturing and Impurity Data for United Phosphorus's Bifenthrin TITGAI. 

## GLN Requirement 

### MRlD 

### Stat Details and/or Deficiency us' 

### 830. Product CSF A 

### Nominal concentrations and certified limits 

### 1550 identity and 1/9/03 

### for the 

### AI &all the impurities 

### provided in composition 

### 45654401 the CSF agree with the study results in MRID 45654401. 830. 

### Description 45654401 A 

### The product specification sheets (MSDS) 

# • 1600 ofmaterials for the starting materials were submitted. used to produce 

### product 830. Descljption 

### 4565440J A 

### The registrant provided detailed 

### 1650 of information about the synthesis ofthe production 

### technical. Amounts ofeach starting process material and the conditions 

### ofthe reaction were nrovided. 

### 830. Discussion 

### 45654401 A 

### The registrant provided the required J670 

### offormation information on the formation 

### ofimpurities. 

### ofimnurities 

# • 830. Preliminary 

### 4565440J A 

### Method validation indicates that the method 

### 1700 analysis is adequate for the determination ofthe 

### ai. Analysis was conducted on 5production batches ofthe 

### ai. 

### 830. Certified 119/03 A 

### The certified limits given in the CSF are in 

### J750 

### limits CSF agreement with the study.

·5· 

# 136

### GLN Requirement MRlD 

### Details and/or Deficiency


### 830. Enforcement 

### 45654401 A 

### "HPLC Method for Detennination of 1800 analytical Bifenthrin" Compilation Report UP!· method Bifentec·A.. dated 3119/02. 

### Bifenthrin test sample is dissolved in HPLC grade acetonitrile, and an aliquot is subjected to reverse phase Le. 

### The cis and trans isomers are combined in asingle LC peak and then separate quantitation 

### accomplished using UV detection at 254 

# • I1JTl. 

### using external standard quantitation. 830. Submission 1115103 

### N Samples will be provided prior to 1900 ofSamples ChemReg. registration. 

### Letter 

# •

·6· 

# 137

### BARCODE:D285142;Reg. No. 7Q5Q6-RJ PRODUCT: Bifel1lhrill 

### Tech.lnsecticideIMiticide Table 2: Ph sical and Chemical Properties for the

### BIFENTHRINtechnical
. GLN Requirement MRlD 

### Stat- Result or Deficiency 

### us' 830.6302 Color 45654402 A White 830.6303 Physical state 45654402 A Solid Powder 830.6304 Odor 45654402 A None 

# • 830.6313 Stability to normal & 

### 45654403 A Waiver Granted. Material elevated temperatures, Letter of is stored and shipped in metals, and metal ions. 1115/03 

### HDPEwnot in contact with 

### metal. 830.6314 

### Oxidation Reduction: 45654401 A Not reported to contain 

### chemical incompatibility oxidizing or reducing 3r.z:ents. 

### 830.6315 Flammabilitv 45654401 A Not flammable 830.6316 Explodability 45654401 A Does not contain explosive components 

### 830.6317 Storage stability 45654403 N No significant change 

### noted after storage at 

# • 54 ±2 C for 14 days
. Stability Testing at 3,6, 9, 

### 12, 18, and 24 months is required for fuU**ft~gistration.** 

### 830.6319 Miscibilitv 

## - NA Not a liouid at 20 C.

-7- 

# 138Table 2: Ph sical and Chemical Properties for the

### BIFEN11fRINtechnical
. GLN 

### Requirement MRID Stat- 

### Result or Deficiency us l 830.6320 

### Corrosion characteristics 45654403 N 

### No significant change was noted after storage at 54 

## ± 2 C for 14 days, 

### Corrosion' Characteristics Testing at 3,6, 9, 12, 18, 

### and 24 months is required for 

### full rCll:istratioD. 830.6321 

### Dielectric Breakdown 

## - A 

### Not Required. Not used 

# • Voltage 

### around electrical 

### cCluinment. 830.7000 IpH 45654401 A 6.52 

### + 0.03 830.7050 UVMsibleabsorPtion 

## - A NANot a liQuid at20 C. 830.7100 Viscosity 

## - A NANot aliauid at 20 C. 830.7200 Meltina Doint/ranae 45654401 A 68-71 C 830.7220 Boilin. Doint/ranae 

## - A NA Not a liauid at 20 C. 830.7300 

### Density/relative density! 45654401 A Density 0.4593**~** 3.83 bulk density Ib/gal Specific gravity 0.3762 

# • 830.7370 

### Dissociation constant in 45654401 A 

### NA Product does not water ionize in water 830.7550 

### Partition coefficient 

## - N (n-octanoVwater) shake flask method
830.7840 Watersolubility: column 

# - N 

### elution method; shake flask method 

### Solubility in 

### organic 

### solvents

-8- 

# 139**'-----------------------~~~--**..•. 

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

Table2: Ph ical and Chemical Properties for the 

### BIFENTHRINtechnical. GLN Requirement 

### MRID Stat- Result or Deficiency us' 830.7950 Vapor pressure 

# - NA Not a liouid at 20 C I 

### A**~** 

### Acceptable; N**~** 

### Not Acceptable (see Deficiency); NA**~** 

### Not applicable. 2 

### For example, "brown" for 830.6302; "155° ell 

### for 830.7200. 

# •

•

-9- 

# 140•



# •

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



### January 8, 2003 

### MEMORANDUM Product Name: BIFENTHRIN TECHNICAL INSECTICIDE/MITICIDE EPA File Symbol: 70506·RI DP Barcode: D285143 Case No: 072204 

### Submission: S620915 Chemical: 128825 Bifenthrin From: Byron T. Backus, Ph.D., Toxicologist Technical Review Branch 

### Registration Division (7505C) To: Susan Stanton/Arnold Layne. PM 03 Insecticide·Rodenticide Branch Registration Division (7505C) Registrant: UNITED PHOSPHORUS INC

.. OFFICE OF PREVEtlTION, PESTICIDES AND TOXIC SUBSTANCES



### ACTION REQUESTED: "United Phosphorus, Inc. has submitted an application to register a new bitenthrin technical product, claiming substantial similarity to FMC's registered technical. They wish to rely on acute toxicity data for FMC's technical to fulfill all ofthe acute tax requirements except oral and dermal toxicity. They have submitted their own oral toxicity (MRID#456544·04) and dermal toxicity (MRID#456544·05) studies. Please determine whether the submitted studies are acceptable and whether they may rely on FMC's data for the other acute toxicity requirements (i.e., is the product substantially similar to FMC's registered technical). Copies ofthe labels and CSFs for the new product and ctled product (EPA Reg. No. 279·3055) are included for your information and review. Note: I was unable to locate a review ofthe cited acutes; however, I have a very recent draft risk assessment for bifenthrin from HED which includes the acute tax profile for bifenthrin technical based on the cited studies, except the inhalation study

.. .'

1 

# 145

# •

• BACKGROUND: According to the copy of the proposed label received by TRB. this product [EPA File Symbol: 70506-RI: Bifenthrin Technical Insecticide/Miticide] has the following ingredient declaration: Active Ingredient: Bifenthrin (2-methyl[1.1·-biphenylJ-3-yl) methyl 3-(2-chloro-3.3.3-trifluoro-1- propenyl)-2.2-dimethylcyclopropanecarboxylate·

........................................99.4% Inert Ingredients:

.......................................................................................................0.6% As 

### part ofthis package. TRB has received the following two acute toxicity studies: acute oral LD50 in rats (MRID 45654404); and acute dermal LD50 in rats (MRID 45654405). COMMENTS AND RECOMMENDATIONS: 1. The two submitted acute toxicity studies (MRIDs 45654404 and 45654405) have been reviewed and have been classified as .acceptable

. 2. While the dermal toxicity study (MRID 45654405) has been classified as acceptable. The report states that in one preliminary range finding study mortality (in 1/4 rats at 500 mglkg. 1/4al 1000 rng/kg. and 214 at 2000 mg/kg) was observed; this was followed by a "main study" at 700. 1260 and 2268 mg/kg. "As sufficient mortality was not observed in the main study, the dose range finding study was conducted again using the dose levels of500, 1000 and 2000 mg/kg

...and the percent mortality observed was 0, 25 and 25, respectively." This information is considered as 6(a)(2) data [refer to CFR40 §152.125], and a more detailed report (which should include how the test material was applied and differences, if any, between the protocol(s) used in the preliminary studies and the final study) should be submitted to the Agency. 3. From the summary listing ofthe acute toxicity profile of Bifenthrin, it is noted that a primary eye irritation study in MRID 00132522 indicates the existing (FMC) registration for technical bifenthrin is in tOXicity category IV by this exposure route. Because there may be subtle physical and/or chemical differences between the two technicals. TRB recommends that, in lieu of an actual eye irritation study for the proposed United Phosphorus Bifenthrin Technical, that it be placed in toxicity category III in terms ofeye irritation potential. This is consistent with the proposed labeling for this product (which includes a FIRST AID statement for eye exposure. as well as the precautionary statement: "Causes moderate eye irritation." The remainder ofthe precautionary labeling (addressing inhalation toxicity, dermal irritation and dermal sensitization potentials) should then be consistent with the existing labeling for FMC technical bifenthrin.

2 

# 146

# •

• 4: Based on the results ofthe reviewed acute toxicity studies, as well as the considerations indicated above, the following is the acute toxicity profile for EPA File Symbo170506-RI BIFENTHRIN TECHNICAL INSECTICIDE/MITICIDE: Acute Oral LD50 Acute Dermal LD50 Acute Inhalation LC50 Primary Eye lnitation Primary Dermal Irritation Dermal Sensitization Acceptable Acceptable Cited Cited Cited Cited Tox. Cat. II (MRID 45654404) Tox. Cat. III (MRID 

### 45654405) Tox. Cat. III(?)' Tox. Cat. III" Tox. Cat. IV Negative 'Summary sheet indicates no existing inhalation toxicity studies. Label for this proposed product is consistent with toxicity category III, and this is acceptable if the FMC product is also in toxicity category III by this exposure route. "Summary sheet indicates the FMC product is in toxicity category IV by this exposure route. As slight ph)'sical 

### andlorchemical differences may impact on eye irritation potential, TRB recommends that, in lieu of a primary eye irritation study on the United Phosphorus Technical Bifenthrin, that it be assigned to toxicity category III by this exposure route. This is consistent with the labeling proposed for this product by United Phosphorus. 5. Based on the acute toxicity profile given above and based on the proposed label use directions, the following is the precautionary labeling for this product, as obtained from the Label Review System: PRODUCT ID #: 070506-00018 PRODUCT NAME: BIFENTHRIN TECHNICAL INSECTICIDE/MmCIDE PRECAUTIONARY STATEMENTS SIGNAL WORD: WARNING

Hazards 

### to Humans and Domestic Animals: May be 

### fatal Ifswallowed. 

### Harmful If absorbed through skin. 

### Harmful If Inhaled. causes moderate eye Irritation. Avoid breathing dust Wash thoroughly 

### with soap and water after handling and before eating, drinking, chewing gum, or using tobacco. Remove and wash contaminated dothlng before reuse.

3


# 147

# •

• FIrstAid: 

### If swallowed: 

## -can a polson control center or doctor Immediately for treatment advice. -Have person sip a glass ofwater ifable to 

### swallow. -Do not Induce vomiting unless told to by a polson control center or doctor. -Do not give anything 

### to an unconscious person. 

### Ifon 

### skin: -Take offcontaminated dothlng. -Rinse skin Immediately 

### with plenty ofwater for IS-20 minutes. 

### -Call 

### a polson control center or doctor for treatment advice. IfInhaled: -Move the person to fresh air. 

### -If

### person Is not breathing, call 911 or an ambulance, then give artlfldal respiration, preferably mouth-tomouth If possible. 

### -Call a 

### polson control center or doctor for further treatment advice. IrIn eyes: -Hold eye open and rinse slowly and gently with water for 15-20 minutes

. -Remove contact lenses, If present, after the first 5 minutes," then continue rinsing. -call 

### a polson control center ordoctorfor treatment advice. NOTE TO PHYSICIAN: Note to PM/CRM/RegIstrant: The proposed label should contain a "Note to PhysJdan". The folloWing statements are suggested types of Information that may be Induded, If applicable:
- technical Information on symptomatology;
- use ofsupportive treabnents to maintain 

### life functions;
- medldne that will counteract the specific physiological effects ofthe pestfdde;
- company telephone number

### to specific medical personnel who can provide specialized medical advice. Have the product container or label with you when calling a polson control center or doctor or going for treatment You may also contact l-S00-xxx-xxxx for emergency medical treabnent Information•

4


# 148

# •

• DATA REVIEW FOR ACUTE ORAL TOXICITY TESTING (B70.11 00, formerty §B1-1) Product Manager: 03 MRID No.: 45654404 Reviewer: Byron T. Backus, Ph.D.
CITATION: Tiwari. 

### V.K. Acule Oral ToxicITY Study of Bifenthrin Technical in Rats. JRF Study No. 3415. Unpublished study prepared by Department ofToxicology. Jai Research Foundation. Valvada 396108. Gujarat. India. Final Report Date: FEB-9-2002. MRID 45654404. SUBMIITER & SPONSOR: UNITED PHOSPHORUS INC. TEST MATERIAL: Bifenthrin Technical; (2-methyl[1.1·-biphenyl]·3-yl)methyl 3-(2-chloro-3.3.3- trifluoro·1-propenyl)·2.2-c1imethylcyclopropanecarboxylate; CAS 82657·04-3; purity 99.2%. a 

### white powder SPECIES: Rat. Wistar AGE(at dosing): young adult. 9 weeks WEIGHT (presumably fasted): Males: 204-270 g; Females: 194·235 9 SOURCE: Breeding facility, Jal Research Foundation EXiiCUTlve SUMMARY: In an acute oral toxicitystudy (MRID 45654404), fasted (17+ hrs) young adult (9 week old) Wlstarrats (5 males and5 females/dose level) we,. orally gavaged with Bffenthrln Technical (a whit.powder containing 99.2% active) In peanut 

### 011 **at**

### a **constant dose**  **volume** 

### of **10 mUkg.**  **Doses In**  **the main**  **study were**  0 **(vehicle only),**  50, 79 and 125 mglkg. At 50 mglkg 015M & 215Fdied; at 79 mglkg415M & 215Fdied; at 125mglkg 515M & 3/5F died. All deaths were within 24hours ofdosage. Symptoms atall dose levels Included **tremors and** **nasal discharge;**  **other observations**  **(at** 

### 79 **mglkg and** **above) included**  abdominalbreathing, nasal Irritation andpiloerection. At 125mglkgsymptoms also **Included tonic-clonic**  **convulsions In**  **a/l animals.**  **Survivors wore**  **generally normal** 

### by**Day** 3. Allsurvivors had weight gains from Day 0 to Day 

### 7 andagain from Day

### 7 to Day 14, **with the**  **exception** 

### ofone **50 mg/kg**  **female who-**  **had the**  **same bodywelght**  **on Day**  7 **and** Day 

### 14. The rats Which died showed findings which Included mottling orcongestion of

### the liver andmottling orcongestion ofthe lungs. 13116 rats found dead hadpulmonary **congestion, and** **It Is**  **reported that**  **this is**  

### a **common finding**  **In dead**  **animals with**  

### no **particular pathological** **significance. Findings**  **In terminally** **sacrificed animals**  **were categorized** **as spontaneous/accidental.**  Oral LD50 Males 

### = 66.19 (95% C.L. of 54.48 to 77.90) mglkg Oral LD50 Females 

## =91.89 (95% C.L of26.67 to 316.63) mglkg Oral LD50 Combined: 74.90 (95% C.L. of 57.29 to 97.92) mglkg **Blfenthrln technical,**  

### a **white powder** **containing** 99.2% **active Ingredient,**  **Is In**  **toxicity** category/lIn tenns oforal toxiCity. Study Classification:Acceptable

5


# 149

# •

• ', ..•.

# _-------------- COMPLIANCE: Signed and dated GLP Compliance (p. 3), Quality Assurance (p. 5), and [No] Data Confidentiality (p. 2) statements were provided. Procedure (Including devIations from 870.1100): Following preliminary range-finding testing, ufour groups of rats, each dose group comprising 5 males and 5 females, were randomly selected and three groups were given a single dose of bifenthrin technical at dose levels of 50, 79 and 125 mgikg". As the test substance is insoluble in water, 

### it was suspended in peanut oil at the required concentrations prior to dosing. The dose solution was stirred to ensure that there were no visible precipitates. Another group was administered peanut oil at a constant dose volume of 10 mUkg

...as control. A dose volume of 10 mUkg body weight was calculated for each rat. All animals were dosed once by gavage (day'O) using a metal cannula

... Animals were deprived offeed for seventeen hours and fifteen minutes prior to dosing and then three hours after dosing.' Resutts' , Number of Deaths/Number Tested Dosage (mg/kg) Males Females Total 

# o(vehicle only) 

### 015 0/5 0/10 50 0/5 . 215 2110 

### 79 4/5 215 6/10 125 5/5 3/5 8/10 Observations: All deaths were within Z4 hours of dosage. Symptoms at all dose levels Included tremors and nasal discharge; other observations (at 79 mg/kg and above) included abdominal breathing I nasal irritation and piloerection. At 125 mg/kg symptoms also included**tonic~c1onic** convulsions in all anImals. Survivors were generally normal by Day 3. All survivors had weight gains from Day 0 to Day 7 and again from Day 7 to Day 14, with the exception of one 50 mglkg female who had the same bodyweight on Day 7 and Day 14. Gross Necropsy: The rats which died showed findings which included mottling or congestion of the liver and mottling or congestion ofthe lungs. 13/16 rats found dead had pulmonary congestion, and it is reported that this is a common finding in dead animals with no particular pathological significance. Findings in terminally sacrificed animals were categorized as spontaneouS/accidental.

6


# 150

# •

• DATA REVIEW FOR ACUTE DERMAL TOXICITY TESTING (870.1200, formerly §81-2) Product Manager: 03 MRID No.: 45654405 Reviewer: Byron T. Backus, Ph.D.
CITATION: TIWari, V.K. Acute Dermal Toxicity Study of Bitenth,;n Technical in Rats. JRF Study No. 3416. Unpublished study prepared by Department 

### ofToxicology, Ja! Research Foundation, Valvada 396108, Gujarat, India. Final Report Date: FEB-9-2002. MRID 45654405. SUBMITTER & SPONSOR: UNITED PHOSPHORUS INC. TEST MATERIAL: Bitenth,;n Technical; (2-methyl[1,1'-biphenylj-3-yl)methyl 3-(2-chloro-3,3,3- trifluoro-1-propenyl)-2,2-dimethylcyclopropanecarboxylate; CAS 82657-04-3; purity 99.2%, a 

### white powder SPECIES: Rat, Wistar AGE(.! dosing): not stated; presumably young adult (consistent with body weight data) WEIGHT: Males: 229-282 g; Females: 216-259 g SOURCE: Breeding facility, Jai Research Foundation EXECUTIVE SUMMARY: In an acute dermal toxicity study (MRID 45654405), groups of5M 

### &

### 5F**young adult**  **Wistar**rats **were dermally**  **exposed for** 

### 24 **hrs (occluded**  **exposure) to**  either2000 mglkg Bffenthrln technical (a white powder with 

### 99.2% purity) mixed with an 

### unspeclnedamount 

### of peanutali "to give 

### a slurry," orto 0.2 mL 

### of peanut all a/ono. **There were**  **no mortalities.**  **9/10** 

### ofthe **rats exposed**  **to** 

### bffenthrin **showed symptoms**  **(tremors)** 

### on **Day 3,**  **and two**  

### of**these rats**  **(both males)**  **a/so had**  **tremors and** **piloerection** on Days 1/-5. Allrats were normal from Day 

### 6 through Day 

### 14. AilS males hadbodywelght gains In the period from Day 0 to Day 

### 7, but ailS females had Weight losses during this **perlodj** 5/5 **males and** **415 females**  **had bodyweight** **gains In**  **the per/od**  **from Day**  7 **to Day**  

### 14. Necropsyfindings **(pinpOint lung**  **hemorrhages in**  **one ma/ej** **bilateral uterine**  **hydrometra In**  **one female)**  **were considered** **spontaneous and**  **unrelated to**  **exposure to**  **bifenthrin.** The reportstates that In 

### onepreliminaryrange finding studymortality (In 114 rats at 500 mglkg, 114 at 1000 mglkg, and 214 at 2000 mglkg) was observed; this was followed by

### a **I'maln study'**  **at 700,**  **1260 and** 2268 **mglkg. liAs**  **sufficient mortality**  **was not**  **observed In**  **the main**  **study, the**  **dose range**  **finding study**  **was conducted** **agaIn using**  **the dose**  **levels** of500, 1000 and 2000 mglkg

...andthepercentmortality observed was 0, 25 and 25, respectively." This information is considered as 6(a)(2) data, and a detailedreport shOUld besubmitted to the Agency. Dermal LD50 Males> 2000 mg/kg (015 died at this dose level) Dermal LD50 Females> 2000 mglkg (0/5 died at this dose level) Dermal LD50 Combined> 2000 mglkg (0110 diedat this dose level) **Bifenthrln technical,**  

### a **white powder** **containing** 99.2% **active, Is**  **In toxicity**  **category** III In terms ofdermal toxicity, based on the dermal LD50 

### > 2000 mg/kg.

7 

# 151

# . ,



# •

• Study Claos!flcallon: Accepfabl • COMPLIANCE: Signed and dated GLP Compliance (p. 3), Quality Assurance (p. 5), and [No] Data Confidentiality (p. 2) statements were provided. Procedure [Including deviations from 870.1200): "A dose range finding study for bifenthrin technical was performed using four (2 male and 2 female) animals per group. The per cent mortality observed were 25, 25 and 50 at the dose levels of 500, 1000 and 2000 mg/kg body weight. Based on above results, main study was conducted at the dose level of 700, 1260 and 

### 2268 mg/kg body weight. As sufficient mortality was not observed at the main study, the dose range finding study was conducted again using the dose levels of 500, 1000 and 2000 mglkg body weight and the per cent mortality observed was 0, 25 and 25, respectively. Therefore, the study was conducted as a limit study using 2000 mg/kg body weight." "Depending on the result of the range finding study. two groups of rats, comprising 5 males and 5 females per group, were randomly selected...and one group was given dermal application of bifenthrin technical at the dose level of 2000 mg/kg body weight. As bifenthrin 1echnical was insoluble in water, the measured/calculated quantity of bifenthrin technical was mixed with peanut oil, to give a slurry, for even application on the exposed part ofthe skin. The other group often animals (5 male and 5 female), which served as control, was simultaneously treated with 0.2 mL of peanut oil and maintained in similar experimental conditions. The test substance was held in contact with the skin with a porous gauze dressing (not more than 

### 8 ply) and Medi tape 330 hypoMallergic surgical tape.. .throughout the 24 hour of exposure period to prevent evaporation ofthe test substance and to ensure that the animals did not ingest 

### it. At the end of the exposure period, the residual test substance was removed using cotton moistened with distilled water." Results" 

# . Number of Deaths/Number Tested Dosage (mglkg) Males Females Combined 0

. 0/5 0/5 0/10 2000 0/5 0/5 0/10 Observations: None ofthe rats showed any clinical signs from Day 0 to Day 2. 5/5 males and 4/5 females had tremors on Day 3; all but 2 males had recovered the following day. The 2 males showed tremors and piloerection on Days 4 and 5, but were normal on Day 6. All 5 males gained weight in the period from Day 0 to Day 7, while all 5 females lost weight during this same period. All males continued to gain weight in the period from Day 7 to Day 14, but one female lost weight during this period and 3 others, although gaining some weight, had still lost a few grams from their initial (Day 0) weight. Gross Necropsy: 2000 mglkg: 3/5 males and 4/5 females had NAD (No abnormalities detected). One male had pin-point hemorrhages (mild) ofthe lungs; the other male had blotched kidneys and a few pinMpolnt hemorrhages of the lungs. One female had partial consolidation in the right cranial lobe ofthe lung.

8


# 152

# . ,



# •

• ACUTE TOX ONE·LINERS 

## 1. bp BARCODE: 0285143 2. PC CODE: 128825 Bifenlhrin 3. CURRENT DATE: January 8, 2003 4. TEST MATERIAL: EPA File SymboI70506·RI; Bifenthrin Technical; (2·methyl[1,1'.biphenylj· 3·yI)melhyI3·(2·chloro-3,3,3·lrifluoro·1·propenyl)·2,2-dimethylcyclopropanecarboxylate; CAS 82657·04-3; purity 99.2%, a white powder Study/Species/Lab MRID Results Tex. Core Siudy#lDate Cat. Grade Acute oral toxicity/rat! Jai 45654404 LD,,(M) 

## = 66.2 (54.5·77.9) mg/kg; LD,,(F) 

## = II A Research Foundation 91.9 (26.7·316.6)mgikg; LD" (Combined) 

## = Gujarat India/Study No. 74.9 (57.3-97.9) mg/kg. Dose levels: 50, 79 & 34151FEB-9·2002 125 mg/kg aftest male rial in peanut oil at a constant dose volume of 10 mUkg, Symptoms at all dose levels included tremors and nasal discharge; other observations (at 79 mg/kg and above) Included abdominal breathing, nasal irritation and piloerection. At 125 mg/kg symptoms also included tonic-clonic convulsions. Survivors were generally normal by Day 3. Acute Dermal Toxicity/rat! 45654405 There were no mortalities among 5M & SF III A Jai Research Foundation dermally exposed to 2000 mg/kg. 9110 rats Gujarat India/Study No. had tremors on Day 3, and 2 of these (both 34161FEB·9-2002. males) had tremors and piloerection on Days 4·5. All rats were normal Days 0-2, Days 6-15. All 5M had bodyweight gains in the period from Day a to Day 7, but all5F had weight losses; 5/5 males and 4/5 females had bodyweight gains in the period from Day 7 to Day 14. Necropsy findings (pinpoint lung hemorrhages In one male; bilateral uterine hydrometra in one female) were considered spontaneous and unrelated to exposure to bifenthrin. Report states that in a preliminary range finding study 1/4 rats at 500 mg/kg.1/4 at 1000 mg/kg, and 214 at 2000 mg/kg died; followed by a -main**study~** at 700. 1260 and 2268 mg/kg. "As sufficient mortartty was not observed in the main study, the dose range finding stUdy was conducted again using the dose levels of 500, 1000 and 2000 mg/kg

... and the percent mortality observed was 0, 25 and 25, respectively.-



# - - - Core Grade Key. A -Acceptable, S
- Supplementary, U
- Unacceptable, V:= SelfValidated

9


# 153

# r
I



# •



# • •


## u.s. ENVIRONMENTAL PROTECTION AGENCY Office of Pesticide Programs


### UNITED PHOSPHOROUS, INC. 423 RIVERVIEW PLAZA TRENTON, NJ 08611 

### Report of Analysis for Compliance with PR Notice 86-5 Thank 

### you for 

### your transmittal of 01/l5/03. Our staff 

# JAN 212003

has completed a preliminary analysis of the material, The results are 

### provided as follows: Your submittal was found to be in full compliance with 

### the standards for submission of ,data contained in PR Notice**86~5.** 

### A copy of your bibliography is enclosed, annotated with Master Record ID's (MRIDS) assigned to 

### each document submitted. Please use these numbers in
. all future references to these documents. Thank you for 

### your cooperation.**I~** 

### you have any questions concerning this data submission, please raise them with the cognizant Product Manager, to whom the data have been released
.



# 154

### ,


## • •



# •



# • •



## TRANSMITfAL DOCUMENT

United Phosphorus, 

### Inc.

740 Springdale Drive Suite 204 

### Exto., PA 

### 19341 

### Submll!er UnitedPhosphorus,lncChemReg lnlemationnl, 

## u.c* 2239-HTackeus Mill

### Drive Lake 

### Ridge, VA 22192-3026 "'ChemReg International is the authorized representative for United Phosphorus, Inc.



# - Document I: Regulatory action in 

### SUpPOrt of

### whicb 

### this package is submitted 

### New ProductRegislIation ("Me-Too') (Bifenlhrin TechnicallnsecticidelMiticide 70S06-Rl)

MRID Administrative Materials



### , Brown, EA Januaxy9,2OO3, Bifenlhrin Technical 

### . 

## 45838001 

## I , 

### Insocticide. Physical & 

### Chemical Properties 

### (Group B). eomoil.tio.Re.ort No. UPI-BIFJ'ECH-B. Company Official Company Name: Company Contact: Phone Number: 

### ChemRcg International. LLC., 

### Authorized Representative for UPI 

### Eliznbelh Anne 

### Brown 703-492-7905



# 158

### , '- 

# .oEPA UnltadStatea 

### Environmental Protection Agency Amendmont other

(bW).

# my product Is

# similaror [dunnest

# [n:::::~:[ "" EPA RogNo. Chock Ifthis Is /J now address Product Nama

Aaanc::v letterdoled**~** Aesubmlssion In responsel0 Agency leiterdated Dec. 12. 2002 

# o Notification
- explain below 

# o "Me Too· Application 

# o Other
- Explain below



# " Unit Packaging wgt

Elizabeth Anna Srov.n 

## p." , Vos No container Package wgt

are true,. fltturale lind complete. ImprbwnmI!nt or ChemAeg international, LlC Authorized Agon!
January 15, 2003 PlasllC 0'"", Paper Other (Spoclfy)

(Stamped)



# 159**--~-- --~---------------------**  

# . .**.r~'~ .,-:~**  -.'



### DP BARCODE, D285143 CASE, 072204 SUBMISSION: 8620915 

### DATA PACKAGE RECORD BEAN SHEET DATE, 08/30/02 page 1 

### of 2 

## * * * CASE/SUBMISSION INFORMATION 

## * * * REGISTRATION ACTION, 166 RESB NEW PRO-OC-MIN CHG CASE TYPE, RANKING CHEMICALS, 10 POINTS () 128825 Bifenthrin 

### (ANSI) 99.4000%



# . ID#, 070506-RI BIFENTHRIN TECHNICAL INSECTICIDE/MITICIDE COMPANY, 070506 UNITED PHOSPHORUS INC PRODUCT MANAGER, 03 ARNOLD LAYNE 703-305-6249 ROOM, CM2 212 PM TEAM REVIEWER, SUSAN STANTON 703-305-5218 ROOM, CM2 237 RECEIVED DATE, 08/30/02 DUE OUT DATE, 02/26/03 

## * 

## * * DATA PACKAGE INFORMATION 

### * 

### * * DP BARCODE, 285143 EXPEDITE, N DATE SENT, 08/30/02 DATE RET. : 

### / / TYPE: 001 Submission Related Data Package**~EMlCAL!** 128825 Bifenthrin (ANSI) 

### CSF, y 

### LABEL, Y 

### ,/..:J.-r-dA ASSIGNED TO DATE IN DATE OUT ADMIN DUE DATE, 81/17/03



### DIV 

# , BRAN, SECT, REVR 

# , CONTR, 

# • RD 

### / / / / NEGOT DATE, 

### / TRB 

### / / / / PROJ DATE, 

### / TOX 

### / / / / / / / / 

## .I / / / 

## * * * DATA REVIEW INSTRUCTIONS 

## * * * United Phosphorus, Inc. has submitted an application to 

### register a new bifenthrin technical product, claiming substantial similarity to FMC's registered technical. They wish to rely on acute toxicity data for FMC's technical to fulfill all of the acute tox requirements except oral and dermal toxicity. They have submitted their own oral toxicity (MRID#456544-04) and dermal toxicity (MRID#456S44-0S) studies. Please determine whether the submitted studies are acceptable and whether they may rely on FMC's data for the other acute toxicity requirements (i.e., is the product substantially similar to FMC's registered technical). Copies of the labels and CSFs for the new product and cited product (EPA Reg. No. 279-3055) are included for your information and review. Note: I was unable to locate a review of the cited acutesj however, I have a very recent draft risk assessment for bifenthrin from HED which includes the acute tox profile for bifenthrin technical based on the cited studies, except the inhalation study. I can't find any information on the cited inhalation study. A copy of the acute toxicity table from HED's draft memo is included for your information. Thanks, Susan Stanton 

### / /



# 160

### ;..,i

. •..
DP BARCODE, 0285143 CASE, 072204 SUBMISSION, S620915 DATA PACKAGE RECORD (CONTINUED) BEAN SHEET 

## * * * DATA PACKAGE EVALUATION 

### * * * No evaluation is written for this data package 

### DATE, 08/30/02 Page 2 of 2


## * * * ADDITIONAL DATA PACKAGES FOR THIS SUBMISSION 

### * 

### * * DP Be 285142 

# •

• BRANCH/SECTION TRB/CHEM DATE OUT 08/30/02 DUE BACK 01/17/03 INS Y 

### CSF Y



# 161 LABEL Y

### ,



# •

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

January 8. 2003 MEMQRANDUM Product Name: BIFENTHRIN TECHNICAL INSECTICIDEIMITICIDE EPA File Symbol: 70506-RI DP Barcode: D285143 Case No: 072204 Submission: S620915 Chemical: 128825 Bilenthrin From: Byron T. 8ackus. Ph.D.• Toxicol09ist Technical Review Branch Registration Division (7505C) To: Susan Stanton/Amold Layne, PM 03 Insecticide-Rodenticide Branch Registration Division (7505C) Registrant: UNITED PHOSPHORUS INC. OFFICE OF PREVENTION, PESTICIDES AND TOXIC SUBSTANCES



### ACTION REQUESTED: "United Phosphorus. Inc. has submitted an application to register a new bifenthrin technical product, claiming substantial similarity to FMC's registered technical. They wish to rely on acute toxiCity data lor FMC's technical to lulfill all 01 the acute tox requirements except oral and dermal toxicity. They have submitted their own oral toxicity (MRID#456544-04) and dennal toxicity (MRID#456544-05) studies. Please detennlne whether the submitted studies are acceptable and whether they may rely on FMC's data lor the other acute toxicity requirements (I.e., is the product substantially similar to FMC's registered technical). Copies 01 the labels and CSFsforthe new product and**c~ed** product (EPA Reg. No. 279-3055) are included lor your Inlonnation and review. Note: I was unable to locate a review 01 the cited acutes; however, I have a very recent draft risk assessmenlfor bifenthrin Irom HED which includes the acute tox profile lor bifenthrin technical based on the cned studies, except the inhalation study

..."

1 

# 162

# •

• BACKGROUND: According to the copy ofthe proposed label received by TRB, this product [EPA File Symbol: 70506-RI: Bifenthrin TechnicallnsecticideiMiticide] has the following ingredient declaration: Active Ingredient: Bifenthrln (2-methyl[1,1 '-biphenyl]-3-yl) methyl 3-(2-chloro-3,3,3-trifluoro-1- propenyl)-2,2-dimethylcyclopropanecarboxylate·

........................................99.4% Inert Ingredients:

......,................................................................................................0.6% 

### As part ofthis package, TRB has received the following two acute toxicity studies: acute oral LD50 in rats (MRID 45654404); and acute dermal LD50 in rats (MRID 45654405). COMMENTS AND RECOMMENDATIONS: 1. The two submitted acute toxicity studies (MRIDs 45654404 and 45654405) have been reviewed and have been classified as acceptable

. 2. While the dermal toxicity study (MRID 45654405) has been classified as acceptable, The report states that in one preliminary range finding study mortality (in 1/4 rats at 500 mglkg, 1/4 at 1000 mglkg, and 

### 214 at 2000 mg/kg) was observed; this was followed by a "main study' at 700, 1260 and 2268 mglkg. "As sufficient mortality was not observed in the main study, the dose range finding study was conducted again using the dose levels of 500, 1000 and 2000 mglkg

...and the percent mortality observed was 0, 25 and 25, respectively." This information is considered as 6(a)(2) data [referto CFR40 §152.125], and a more detailed report (which should include how the test material was applied and differences, if any, between the protocol(s) used in the preliminary studies and the final study) should be submitted to the Agency. 3. From the summary listing ofthe acute toxicity prOfile of Bifenthrin, it is noted that a primary eye irritation study in MRID 00132522 indicates the existing (FMC) registration for technical bifenthrin is in toxicity category IV by this exposure route. Because there may be subtle physical and/or chemical differences between the two technicals, TRB recommends that, in lieu of an actual eye irritation study for the proposed UnHed Phosphorus Bilenthrin Technical, that it be placed in toxicity category III in terms of eye irritation potential. This is consistent with the proposed labeling for this product (which includes a FIRSTAID statement for eye exposure, as well as the precautionary statement: "Causes moderate eye irritation." The remainder ofthe precautionary labeling (addressing inhalation toxicity, dermal irritation and dermal sensHization potentials) should then be consistent with the existing labeling for FMC technical bifenthrin.

2 

# 163

# •

• 4: Based on the results ofthe reviewed acute toxicity studies, as well as the ccnsiderations indicated above, the following is the acute toxicity profile for EPA File Symbol 70506-RI BIFENTHRIN TECHNICAL INSECTICIDE/MITICIDE: Acute Oral LD50 Acute Dermal LD50 Acute Inhalation LC50 Primary Eye Irritation Primary Dermallrrilation Dermal Sensitization Acceptable Acceptable CHed CHed CHed CHed Tax. Cat. II (MRID 45654404) Tax. Cat. III 

### (MRID 45654405) Tax. Cat. III(?)* Tax. Cat. III" 

### Tax. Cat. IV Negative 'Summary sheet indicates no existing inhalation toxicity studies. Label for this proposed product is consistent with toxicity category III, 

### and this is acceptable IT the FMC product is also in toxicity category III by this exposure route. "Summary sheet indicates the FMC product is in toxictty category IV by this exposure route. As 

### slight physical andlor chemical differences may impact on eye irritation potential, TRB recommends that, in lieu of a primary eye irritation study on the United Phosphorus Technical Bifenthrin, that it be assigned to toxicity category III by this exposure route. This is consistent with the labeling proposed for this product by United Phosphorus. 5. Based on the acute toxicity profile given above and based on the proposed label use directions, the following is the precautionary labeling for this product, as obtained from the Label Review System: PRODUCT ID #: 070506-00018 PRODUCT NAME: BIFENTHRIN TECHNICAL INSECllCDE/MmCDE PRECAlfTIONARY STATEMENTS SIGNAL WORD: WARNING

Hazards

### to Humans and DomaatIcAnimal.: May be fatal 

### W swallowed. HallTlfullfabsorbed through skin. HallTlfullf Inhaled. Causes moderate eye Irritation. Avoid breathing dust. Wash thoroughly with soap and water after handling and before eating, 

### drinking, chewIng gum, or usIng tobacco. Remove and wash contaminated dothlng before reuse.

3 

# 164

# •

• F1rstAld: If

### swallowed: -Cali a polson control center or 

### doctor immediately for treabnent advice. -Have person sIp a glass ofwater ifable 

### to swallow. -Do not Induce vomiting unless told 

### to by a poison control center or doctor. -Do not give anything 

### to an unconscious person. Ifon skin: 

### -Take offoonlllminased clothing. -Rinse skin Immedlately wfth plenty of water for 15-20 minutes. -Call 

### apolson controt cenrer ordoctor for b"eatment advice. 

### 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 polson control center or doctor for further treatment advice. 

### If In eyes: -Hold e-{e open and rinse slowly and gently with water for 15-20 minutes. -Remove contact lenses, if present, after the 

### first 5 minutes, then continue rinsing• 

### -Call 

### apolson control center or doctor for treatment advice. NOTE TO PHYSICIAN: Note 

### to PM/CRM/Reglstrant: The proposed 

### label should ronlllin a "Note 

### to Physldan"_ The 

### following sIlItements are suggested types 

### ofInfonmatlon that may be Included, If applicable: - 

### technical Information on symptomatology; - use of supportive treatments 

### to maintain life functions; • medicine 

### that will counteract the specific physiological effects of the 

### pestlcide; - company telephone number

### to spedflc medical personnel who can provide spedalized medical advice. Have the product container or label with you when calling a polson controf center or doctor or going for treabnent You may also contact 1-800-xxx-xxxx for emergency medical treabnent Information.

4 

# 165

# •

• DATA REVIEW FOR ACUTE ORAL TOXICITY TESTING (870.1100, formerly §81-1) Product Manager: 03 MRID No.: 45654404 Reviewer: Byron T. Backus. Ph.D.
CITATION: Tiwart, V.K. Acute Oral Toxicity Study of Bifenthrtn Technical in Rats. JRF Study No. 3415. Unpublished study prepared by Oepartment ofToxicology. Jai Research Foundation. Valvada 396108. Gujaral. India. Final Report Date: FEB-9-2002. MRID 45654404. SUBMITTER & SPONSOR: UNITED PHOSPHORUS INC. TEST MATERIAL: Bifenthrin Technical; (2-methyl[1,1'-biphenylj-3-yl)methyl3-(2-chloro-3,3.3- trifluoro-1-propenyl)-2,2-dimethylcyclopropanecarboxylate; CAS 82657-04-3; purtly 99.2%. a white powder SPECIES: Rat, Wistar AGE(a! dosing): young aduR. 9 weeks WEIGHT (presumably fasted): Males: 204-270 g; Females: 194-235 9 SOURCE: Breeding faCility, Jai Research Foundation EXECUTIVE SUMMARY: In an acute or.1 toxicitystudy (MRID 4S654404), fasted (17+ hrs) young adult 

### (9 week old) Wlstar rats 

### (5 males and

### 5 females/dose level) were orally gavaged with Blfenthrln Technical (a white powder containing 99.2% active) Inpeanut all 

### at

### a constant dose volume 

### of10 mUkg. Doses in tho main study were 0 (vehicle only), 50, 79 and 125mglkg. At 

### 50 mglkg O/SM & 21SFdied; at 79 mglkg 415M & 215F died; at 125 mglkg 5!SM & 3/SF died. All deaths were within 24 hours ofdosage. Symptoms at all dose levels Included **tremors and**  **nasal discharge;**  **other observations**  **(at** 

### 79 **mglkg and**  **above) included**  abdominal breathing, nasal Irritation andpiloerection. At 12S mglkg symptoms also **included tonic-clonic**  **convulsions In**  **aI/ animals.**  **Survivors were**  **generally normal**  **by Day**  3. Allsurvivors had weight gains from Day 

### 0 to Day 

### 7 and again from Day 

### 7 to Day 14, with the exception ofone 

### 50 mglkg female who had the same bodywelght on Day 

### 7 and Day 14. **The rats**  **which died** **showed findings**  **which included**  **mottling or** **congestion** 

### of**the liver**  **and mottling**  **or congestion**  

### ofthe **lungs. 13116**  **rats found**  

### dead **had pulmonary**  **congestion, and**  **It Is**  **reported that**  **this Is**  

### a **common finding**  **In dead**  **animals with**  **no** particularpathologicalslgntncance. Findings In terminally sacrificed animals were **categorized**as **spontaneous/accidental.** Orel LDSO Males 

## =66.19 (95% C.L. of54.48 to 77.90) mglkg Or.1 LDSO Fem./es 

### =91.89 (9S% CoL. of26.67 to 316.63) mglkg Oral LDSO Combined

### = 74.90 (9S% C.L. of57.29 to 97.92) mglkg **Blfenthrln technical,**  

### a **white powder** **containing** 99.2% **active Ingredient,**  **Is In**  **toxicity** categoryII In terms oforal toxicity. Study Classlficat/on:Acceptable

5 

# 166

# •

• COMPLIANCE: Signed and dated GLP Complianc. (p. 3), Quality Assurance (p. 5), and [No) OatF) Confidentiality (p. 2) statements were provided. Procedure (Including deviations from 870.1100): Following prsllminary range-finding testing, "four groups of rats, each dose group comprising 5 males and 5 females, were randomly 

### selected and three groups were given a single dose of bifenthrin technical at dose levels of 50, 79 and 125 mg/kg... As the test substance is insoluble in water, it was suspended in peanut oil at the required concentrations prior to dosing. The dose solution was stirred to ensure that there 

### were no visible precipitates. Another group was administered peanut oil at a constant dose volume of 10 mUkg...as control. A dose volume of 10 mUkg body weight was calculated for each rat. All animals were dosed once by gavage (day 0) using a metal cannula... Animals were deprived offeed for seventeen hours and fifteen minutes prior to dosing and then three hours after**dosing.~** Results' 

# . Number of Oeaths/NumberTested Dosage (mg/kg) Males Females Total



## o(vehicle only) 0/5 0/5 0110 50 0/5 215 2110 

### 79 4/5 215 6/10 125 5/5 3/5 8/10
. Observations: All deaths were within 24 hO\Jrs of**do~age.** Symptoms at all dose levels included tremors and nasal discharge; other observations (at 79 mg/kg and above) included abdominal breathing, nasal irritation and plloerection. At 125 mglkg symptoms also included tonic·clonic convulsions in all animals. Survivors were generally nonnal by Day 3. All survivors had weight gains from Day 0 to Day 7 and again from Day 7 to Day 14, with the exception of one 50 mg/kg female who had the same bodyweight on Day 7 and Day 14. Gross Necropsy: The rats which died showed findings which included mottling or congestion of the liver and mottling or congestion ofthe lungs. 13/16 rats found dead had pulmonary congestion, and 

### it is reported that this is a common finding in dead animals with no particular pathological significance. Findings in tenninally sacrificed animals were categorized as spontaneous/accidental.

6 

# 167

# •

• DATA REVIEW FOR ACUTE DERMAL TOXICITY TESTING (870.1200, formerly §81-2)



# . , Product Manager: 03 MRID No.: 45654405 Reviewer: Byron T. Backus, Ph.D.
CITAnON: nwart, V.K. Acute Dennal Toxicity Study of**B~enthrtn** Technical in Rats. JRF Study No. 3416. Unpublished study prepared by Department ofToxicology, Jai Research Foundalion, Valvada 396108, Gujarat, India. Final Report Date: FEB-9-2002. MRID 45654405. SUBMITIER & SPONSOR: UNITED PHOSPHORUS INC. TEST MATERIAL: Blf.nthrin Technical; (2-methyl[l,l'-biphenylj·3-yl)methyl 3-(2-chlora·3,3,3- trtfluoro-1-propenyl)·2,2-dimethylcyclopropanecarboxylate; CAS 82657-04-3; purtty 99.2%, a white powder SPECIES: Rat, Wistar AGE(at dosing): not stated; presumably young adult (consistent with body weight data) WEIGHT: Males: 229-282 g; Females: 216-259 g SOURCE: Breeding facility, Jai Research Foundalion EXECUTIVE SUMMARY; In an acute dermal toxicity study (MRID 45654405), groups of5M & 5Fyoung adult Wlstar rats were dermally exposed for24 hrs (occluded exposure) to either 2000 mg/kg Blfenthrin technical (a whitepowder with 99.2%purity) mixed with an **unspecified amount**  

### of**peanut 0/1** **'~o give**  

### a**slurry~ II**  **or to**  **0.2 mL**  **of peanut**  **oil alone.**  **There were**  **no mortalities.**  **9/10** 

### of**the rats**  **exposed to**  **bffenthrln showed** **symptoms (tremors)**  **on Day** 3, **and**two of**these ~ts**  **(both males)**  **also had**  **tremors and** **plioerection** on Days 

### 4-5. Allrats were normal from Day 

### 6 through Day 

### 14. All 

### 5 males hadbodywelght **gains In**  **the period**  **from Day**  **0 to**  **Day** 7, **but**all

### 5 **females had**  **weight losses**  **during this**  period; 5/5 males and415 females hadbodyweightgains In theperiod from Day 7 to Day 

### 14. Necropsy findings (pinpoint lung hemorrhage$ln one male; bilateral uterine hydrometra **in one**  **female) were**  **conSidered spontaneous**  **and unrelated** 

### to **exposure to**  **bifenthrin.** The reportstates thatIn one preliminaryrange finding studymortality (In 114 rats at 500 mg/kg, 114 

### at 1000 mg/kg, and 214 

### at 2000 mg/kgJ was observed; this was followed by

### a "main study"at 700, 1260 and2268 mg/kg. "As sufficient mortality was not observedIn **the main**  **study. the**  **dose range**  **finding study**  **was conducted** **again using**  **the dose**  **levels** of500, 1000 and 2000 mg/kg

...and thepercent mortality observed was 0, 

### 25 and 25, respecUvely." This InformaUon Is considered 

### as 6(0)(2) data, and

### a detailed report should be submitted

### to the Agency. Dermal LD50 Males> 2000 mg/kg (0/5 died

### at this dose level) Dermal LD50 Females> 2000 mg/kg (015 died at this dose/eveQ

. Dermal LD50 Combined> 2000 mg/kg (0/10 diedat this dose level) **Blfenthrln technical,**  **a white**  **powder containing**  99.2% **actIve, Is**  **In tOXicity**  **category**III In terms ofdermal tOXicity, based on the dermal LD50 

### > 2000 mg/kg.

7 

# 168

# •

• Study Classification: Acceptable

, COMPLIANCE: Signed and dated GLP Compliance (p. 3), Quality Assurance (p, 5), and [No]

Data Confidentiality (p. 2) statements were provided, Procedure (Including deviations from 

### 870.1200): "A dose range finding study for bifenthrin technical was performed using four (2 male and 2 female) animals per group. The per cent mortality observed were 

### 25, 25 and 

### 50 at the dose levels of

### 500, 1000 and 

### 2000 mglkg body weight. Based on above results, main study was conducted at the dose level 

### 01700, 1260 and 2268 mg/kg body weight. As sufficient mortality was not obsBlVed at the main study, the dose range finding study was conducted again using the dose levels of 500,1000 and 2000 mg/kg body weight and the per cent mortality observed was 

### 0, 25 and 

### 25, respectively, Therefore, the study was conducted as a**lim~** study using 

### 2000 mg/kg body weight."**~Depending** on the result of the range finding study, two groups of rats, comprising 5 males and 

### 5 females per group, were randomly selected...and one group was given dermal application of bffenthrin technical atthe dose l.v.1 of 

### 2000 mglkg body w.ight. As bifenthrin technical was insoluble in water, the measured/calculated quantity of bifenthrin technical was mixed with peanut oil, to give a slurry, for even application on the exposed part ofthe skin. The other group often animals (5 male and 5 female), which selVed as control, was simultaneously treated with 0.2 mL of peanut oil and maintained in similar experimental conditions. The test substance was h.ld in contact**w~h** the skin with a porous gauze dr.ssing (not more than 8 ply) and Medi tap• 330 hypo-allergic surgical tap

.... throughout the 24 hour of .xposur. period to prevent evaporation ofthe test substance and to ensure that the animals did not ingest it. At the end of the exposure period, the. residual test substance was removed using cotton moistened with distilled water: Results' 

# . Number-of Deaths/Number Tested Dosage (mg/kg) Males Females Combined 

### 0 0/5 0/5 

### 0110 2000 0/5 0/5 0/10 Observallons: None ofthe rats showed any clinical signs from Day 0 to Day 2, 515 males and 4/5 females had tremors on Day 

### 3: all but 2 males had recovered the following day. The 2 males showed tremors and piloerection on Days 4 and 5, but were normal on Day 6. All 5 males gained w.ight in the period from Day 0 to Day 7, while ailS f.maleslost w.ight during this sam. period. All males continued to gain weight in the period from Day 7 to Day 14, but one female lost weight during this **period** and 3 others, although gaining some weight, had still lost a few grams from th.ir**in~ial** (Day 0) weight. Gros. Necropsy: 

### 2000 mglkg: 

### 3/5 males and 

### 4/5 females had NAD (No abnonnalities d.t.cted), On. male had pin-point hemorrhages (mild) of the lungs; the oth.r male had blotched kidneys and a few**pin~point** hemorrhages of the lungs. One female had partial consolidation in the right cranial lob. ofthe lung,

8 

# 169

# •



# .. ACUTE TOX ONE-LINERS



# .1: DP BARCODE: D285143

2_ PC CODE: 128825 Bifenthrin 3. CURRENT DATE: January 8. 2003 4. TEST MATERIAL: EPA File Symbol 70506-RI; Bifenthrin Technical; (2-methyl[1.1'-biphenYIJ3-yl)methyl 3-(2-chloro-3,3,3-trifluoro-1-propenyl)-2,2-dimethylcyclopropanecarboxylate; CAS 82657-04-3; purity 99.2%, a white powder

ok MRID Results 

### Toxc Core

## ~ Cat

### ~ Acute oral toxicity/raV Jai 45654404 LD",(M) 

### = 66.2 (54.5-77.9) mg/kg; LD",(F) 

### = II A Research Foundation 91.9 (26.7-316.6)mg/kg; LD", (Combined) 

### = Gujarat India/Study No. 74.9 (57.3-97.9) mg/kg. Dose levels: 50, 79 & 3415/FEB-9-2002 **125 mg/kg**  of test material In peanut oil at a constant dose volume of 10 **mUkg,** Symptoms at all dose levels included tremors and nasal discharge; other observations (at 79 mglkg and above) included abdominal breathIng, nasal irritatlon and piloerection. At 125 **mg/kg** ·symptoms also induded tonic-clonic convulsions. SurvIvors were generally normal by Day 3. Acute Dermal Toxicity/rat! 45654405 There were no mortalities among 5M & SF III A Jai Research Foundation dermally exposed 

### to 2000 **mg/kg. 9110**  rats Gujarat India/Study No. had tremors on Day 3, and 2 of these (both 3416/FEB-9-2002. males) had tremors and piloerection on Days 4-5. All rats were normal Days 0-2, Days 6-15. All 5M had bodyweight gains in the period from Day a to Day 7, but all5F had weight losses; 515 males and **4/5** females had bodyweight gains in the period from Day 7 to Day 14. Necropsy findings (pInpoint lung hemorrhages in one male; bilateral uterine hydrometra In one female) were considered spontaneous and unrelated to exposure to bifenthrin. Report states that in a preliminary range findIng study 1/4 rats at 500 mg/kg, 1/4 at 1000 mg/kg, and 214 at 2000 **mg/kg** died; followed by a**~maln** study- at 700, 1260 and 2268 m9/kg. 

### -As sufficient mortality was not observed In the main study, the dose range finding study was conducted again using the dose levels ofsao, 1000 and 2000 .111,. and the percent

# ~=, was a, 25 and 25. Oore Grade Key: A ' ',5**.V=~.IT**

9 

# 170

### ACUTE TOXICITY

00132519 

# •

•

25

### h-~'" 

# ,..",,,j 'J),-,.F/-!M'/) Nsf 

## Ms'ssm.-f. -;;;:- 

# b,.,c;;..((."

...

II

IV


### not asensitizer



# 171 '-----------------------------------

# •

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



### United Phosphorus,lnc. 

### clo 

## M.S. Elizabeth A. Brown, Ph.D. ChemReg International, LLC 1990 Old Bridge Road, Suite 201 Lake Ridge, VA 22192-2383 Dear Ms. Brown: 

## DEC I2 2002

SUBJECT: Product Chemistry Review 

### Bifenthrin Technical InsecticideIMiticide EPA File Symhol: 70506-RI OFFlCEOF PREVENTION, PESTICIDES AND TOXIC SUBSTANCES



### EPA has completed its review ofproduct chemistry data submitted in support ofthis application forregi.tration (MRIDf1456544-0I, 456544-02 nod 456544-(3). 

### A copy ofthe 

### review is enclosed for your"records. 

### The review identifies a numberofdeficiencies which must he eddressed before this 

### product con 

### he registered. 'Furthermore, until 

### edditional product cbemistry informntion is 

### submitted, we cannot niake the determination whetherthe 

### product is substantially similarto 

### FMC's bifenthrin technical (EPA Reg. No. 279-3055). 

### Please referto the enclosed review for details 

### regarding the product chemistry data

### deficiencies. EPA bas notyet 

### completed itsreview ofth. acute toxicity data 

### submitted/cited to support registration. We

## will edvise you ofthe results of

### ourreview once it is completed. Ifyou bave any 

### questions regarding this 

### action, please contact Susan Stanton 

### ofmy team 

### at (703) 

### 305-S218•



### Enclosure 

### Sincerely yours.

# ;xI~/~tf George

### T. LaRocca ProductManager (13) Insecticide Branch Registration Division (750SC)



# 172

## , , • 

### . 

# . :PP BARCODE, D285142 CASE, 072204 SUBMISSION, S620915 DATA PACKAGE RECORD BEAN SHEET DATE, 08/30/02 Page**~** of 1



### CASE TYPE, RANKING CHEMICALS, 

## * * * CASE/SUBMISSION INFORMATION 

## * * * REGISTRATION 10 POINTS () 

### 128825 Bifenthrin ACTION, 166 RESB NEW PRO-OC-MIN CHG (ANSI) ID#, 070506-RI BIFENTHRIN TECHNICAL INSECTICIDE/MITICIDE COMPANY, 070506 UNITED PHOSPHORUS INC 99.4000%

PRODUCT MANAGER, 03 ARNOLD LAYNE 703-305-6249 ROOM, CM2 212 PM TEAM REVIEWER, SUSAN STANTON 703-305-5218 ROOM, CM2 237 RECEIVED DATE, 08/30/02 DUE OUT DATE, 02/26/03 

## * * * DATA PACKAGE INFORMATION 

## * * 

## * DP BARCODE, 285142 EXPEDITE, N DATE SENT, 08/30/02 DATE RET., 

### / /**~MICAL,** 

### 128825 Bifenthrin (ANSI)**~** 

### TYPE: 001 Submission Related Data Package ASSIGNED TO



### DIV , RD BRAN, TRB 

### SECT, CHEM CSF, Y 

### LABEL, Y 

### DATE IN DATE OUT

### I!>/~/&t;. 

### / / ADMIN DUE DATE, NEGOT DATE,

PRoJ DATE, 

## /';;--7

# -.:PeL. Ql/17/03 

### / / "l/ 

## '0/ / / / / 

### "l/'O/ / / REVR

### ,""~.."..., 

### CONTR, 

### "2/ fb/",'" 

### ''1/,0**/O~** 

### / / / 

### / 

# • * * * DATA REVIEW INSTRUCTIONS 

### * 

### * * United**Phosp~orusl** 

### Inc. has submitted an application to register a me-too technical bifenthrin product. In support of the application they have submitted Group A product chemistry data (MRID#456544-01), an accelerated storage stability study (MRID#456544-03) and some Group B data (color, physical state and odor; MRID# 456544-02). For 

### other requirements they are using the cite-all method, based on the product's substantial similarity to FMC's registered technical (EPA 

### Reg. No. 279-3055). 

### Please review the submitted data and determine whether they are acceptable. Also, please determine whether the product is substantially similar to FMC's technical and whether they have submitted or cited adequate data to fulfill the product chemistry requirements for a 

### technical product. A 

### copy of the data matrix listing submitted and cited data 

### is included for your review. I 

### have also attached copies of the CSFs and labels for this new product and FMCs technical for your review. 

### If you have any questions, let me know. Thanks, Susan Stanton 

## * * * DATA PACKAGE 

### EVALUATION 

## * * * No evaluation 

### is written for this data package 

# 173

# ,'-

DP BARCODE: D285142


# .. CASE: 072204

SUBMISSION: S620915 DATA PACKAGE RECORD (CONTINUED) BEAN SHEET DATE: 08/30/02 

### page 2 

### of 1 

## * * * ADDITIONAL DATA PACKAGES FOR THIS SUBMISSION 

### * * 

## * DP BC 285143 

# •



# • BRANCH/SECTION TRB/TOX



### , DATE OUT 08/30/02 DUE BACK 01/17/03 INS Y CSF Y



# 174 LABEL Y

# ..

DATE: SUBJECT: FROM:

TO:
DPBARCODE: EPA REG. NO.: REGISTRANT: USE: December 10, 2002 

### Product Chemistry Review ofBifenthrin Technical Linda L 

### Kutney Product Chemistry Team Technical Review Branch/RD (7505C) Arnold Layne, Susan Stnnton PM 3 Insecticide Branch! RD (7505C) D285142 70506-RI United Phosphorus, Inc. Insecticide 

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



### • INTRODUCTION:



# • United Phosphorus, Inc. has**~ubmitted** 

### produ.ct chemistry data to support the registration of "Bifenthrin Technical.lnsecticideIMiticide:' The chemical name for Bifenthrin is "(2-methyI[I,I'-biphenyl]-3-yl)methyl-3-(2-chIoro-3,3,3-trifluoro-I-propenyl)-2;2- dimethylcycIopropanecarboxylate." The proposed basic CSF is dated 2/8/02. 

### This proposed label is for inseciticidelmiticide**non~food** 

### use, including as atermiticide and soil contact nonfurnigation treatment, as wood treatment and protection, as outdoor insect control, on ornamental plants, trees. shrubs and woody vines, 

### residential lawns and for indoor insect control., spot or crack and ctevice treatment in non-food areas. Use in food or feed areas is prohibited. The product chemistry data has been submitted under MRIDs 456544-01, 456544 -02 and 456544-03. 

### In their letter of**4/8/02,** 

### United Phosphorus has also claimed similarity to FMC's Bifentluin Technical. Reg. No. 279-3055, containing 94.0% ofBifenthrin ai, and a minimum of 97% cis isomers and amaximum of3% oftrans 

### isomers, as listed on the label accepted 6121101. No minimum oftrans 

### Bifenthrin isomers was included on the approved label.

-1- 

# 175

# • , ,


### BARCODE:D285142;Reg. No. 70506·RI PRODUCT: Bifetllhrin 

### Tech.lnsecticideIMiticide SUMMARY OF FINDINGS: I. 

### The product chemistry data submitted corresponding to guideline reference 830.1600 (Description ofmateria! used to produce the product) satisfY the data requirements of40CFR§ 158.160. 2. The product chemistry data submitted corresponding to guideline reference 830.1620 

### ( Description of production process) satisfY the data requirements for 40CFR§ 158.162. 3. The product chemistry data submitted corresponding to guideline reference 830.1670 (Discussion on the ronnalien ofimpurities)satisfy the data requiremen!s for 

### 4OCFR§158.167.

-2- 

# 176

### , 

# .



# •



# • ------- ----- -**--------------~-. ~-----~----------~** 



### BARCODE:D285I42;Reg. No. 7Q506-RI PRODUCT: 

### Bi(entluin Tech.lnsecticidelMiticide CONCLUSION: 

### The nominal concentration ofbifenthrin in Bifenthrin Technical InsecticideIMiticide does not fall within the upper and lower certified limits claimed for FMC's Bifenthrin Technical. Insufficient physical chemical data were submitted to conclude that the proposed technical was 

### substantially similar to FMC's Bifenthrin Technical, Reg. No. 279·3055, from a physical chemistry standpoint. TRB concludes that the registration request for Bifenthrin Technica1 InsecticidelMiticide is not acceptable, from a product chemistry standpoint. Deficiencies are numbered below, 

### grouped by type. CSF deficiencies include: 1. A

### value must be 

### given for density in block 7, in agreement with the study results. 2. Avalue must be 

### given for pH in block 8, in agreement with the study results. 3. The "non-applicable" flash point given in block 9**~ust** 

### be supported by study results. 4. The chemical name for bifenthrin must 

### be included in column 10 oftlle CSF, as required. 5. The minimum listed for the cis isomer in column 10 (for the total bifentluin), 97%, does not agree with the lower certified limit for the cis isomer given in column 14b. 6. It 

### should be 

### very 

### clearthat the minimum and maximums listed in column 10 

### for cis and trans isomers ofbifentlrrin correspond to the fractions oftbe total bifenthrin. Subgroup A physical cbemical data requirements include: 

### 7. product identity and compositioD (guideline reference 830.1550, 40CFR158.l55) The nominal, upper and lower concentrations ofbifenthrin in Bifenthrin Technical InsecticidelMiticide listed in tlle CSF does not agree 

### with the values listed in the study (MRID 

### 456544·01). 8. certified limits (guideline reference 830.1750, 40CFRI58.175) See comments included under heading, CSF, above. Note that the certified limits given in 

### the study do not agree with those on 

### the CSF. This must be 

### explained and corrected. The product chemistry data submitted corresponding to guideline reference 830.1550 (product identity & 

### Composition), and 830.1750 (Certified limits) do not satisfY the data requirements of40CFR§158.155 and 158.175 respectively. ·3· 

# 177

# •

• . . "



### 9. The product chemistry data submitted corresponding the guideline reference 830.1700 (Preliminary analysis) do not satisfY the dsta 

### requirements of40CFR§158.170 because they do 

### not support the nominal and upper and lower certified limits on the CSF. 10. Analytical Method (guideline reference 830.1800, 40CFRI58.180) The method indicates 

### that cis and trans bifentluin is s.eparated and quantitated, but the Registrant should give details as to how this is accomplished. 11. Samples must 

### be submitted to the Agepcy laboratory upon registration ofthe product (guideline 830.1900, 40CFRI58.190). For full registration, United Phosphorus must submit the following Subgroup B physical chemical studies (See 40CFR Section 190): STUDY: 

### Stability to normal and elevated temperatures. meta1s, metal ions Oxidation Reduction: chemical incompatibility Flammability Exp10dability Storage stability 

### Corrosion Characteristics pH 

### Melting point/range Boiling point/range DensitylRelative DensitylBulk Density 

### Dissociation constant in water Partition coefficient (n-octlwater)shake flask method Water Solubility column elution method, shake flask method 

### Solubility in organic solvents

-4- GUIDELINE REFERENCE #: 

### 830.6313 830.6314 830.6315 830.6316 830.6317 830.6320 830.7000 830.7200 830.7220 830.7300 830.7370 830.7550 830.7840



# 178**--~--------~--------**



# •

• BARCODE:D285142;Rcg. No. 7Q5Q6-Rl PRODUCT: BifemhrinIech,lns<clicjdeIMjticide 830,1550. Produclldentity: Common Name: Bifenthrin Technical Chemical Name: "(2-metbyl[1 ,I'-biphenyl]-3-yl)metbyl-3-(2-chloro-3,3,3-trifluoro-lpropenyl)-2,2-diroetbylcyclopropaneearboxylate." CAS No.: 82657-04-3 for cis isomer, 83322-02-3 for trans isomer 

### PC Code No.: 128825/or cis andtrans m6: Empirical formula: C23 H22 CI F3 02 Molecular Weight: 422.9 glMole Structural formula and additional product identity data (from MRlD 456544-01)

rllldolN.......'**~** I'orJnl>/a;: Molow,..- WdJ::Im $

.....**cwn.J~**



### -5- 

# 179**,-----------~---~---~~** -**~---~**



# ..
BARCODE:D28S142;Reg. No. 70506-RI PRODUCT: Bifenlhrin 

### Tech.InsecticideIMiticide REVIEW OF PRODUCT CHEMISTRY, OPPTS 830 SERIES

Table I: Manufacturing and Impurity Data for United Phosphorus's Bifenthrin TITGAI. 

### GLN Requirement 

### MRID Sl'Itus Details and/or Deficiency 

### 830. Product 

### CSF 

### N Nominal concentrations and certified 

### limits 1550 identity and 2/8/02 

### for the AI & 

### all the impurities provided in composition 

### 456544- the CSF do not agree with the study results 01 in MRID 456544-0 l. 

### 830. Description 

### 456544- A 

### The product specification sheets (MSDS) 1600 ofmaterials 01 for the starting materials were submitted. 

# • used to 

### produce

, product 830. Description 

### 456544- A 

### The registrant provided detailed information 1650 of 01 about the synthesis ofthe 

### technical. production 

### Amounts ofeach starting material and the : process conditions ofthe reaction were orovided. 

### 830. Discussion 

### 456544- A 

### The registrant provided the required 1670 offormation 01 infonnation on the formation ofimpurities. 

### ofimourities 830. Preliminary 456544- A 

### Method validation indicates that the method 1700 analysis 

### 01 is adequate for the detennination ofthe 

### aL 

# • Analysis was conducted on 5 production 

### batches ofthe ai. 

### 830. Certified 

### 218/02 

### N The certified limits given in the CSF are not 

### 1750 limits 

### CSF in agreement with the studv.



### -6- 

# 180

### Table I: Manufacturing and Imouritv Data for United Phosohorus 's Bifenthrin TfTGAI. GLN Requirement 

### MRlD**St~tus** 

### Details and/or Deficiency 

### 830. Enforcement 

### 456544- A "HPLC Method for Determination of 1800 analytical 01 Bifenthrin" Compilation Report**UPI~** 

### method 

### Bifentec-A., dated 3119/02. 

### Bifenthrin test sample is dissolved in HPLC 

### grade acetonitrile, and an aliquot is subjected to reverse phase 

### Le. The cis and trans 

### isomers are combined in a single LC peak: and then separate quantitation 

### accomplished using UV detection at 254 run. using external standard quantitatian. 

### .-The methodshouldexplain how cis and 

# • Irans bifenthrin ;s separatedand quantitated 

### 830. Submission 

### 456544- A Samples must beprovided priorto 

### 1900 ofSamples 01 registration.

I 

### A**~** 

### AcCeptable; N = 

### Unacceptable (see Deficiency); N/A

### ~ 

### Not Applicable
. 

# •

-7- 

# 181

### BARCODE:D285142;Reg. No. 70506·RJ PRODUCT: Birenlhrin Tech.!nsecticidelMiticide Table 2: Ph sical and Chemical Properties for tl,e BIFENTHRINtechnicai

. GLN 

### Requirement MRID Stat· Result or Deficiency 

### us' 830.6302 Color 

### 456544·02 A White 

### 830.6303 Physical state 456544·02 A Solid Powder 830.6304 Odor 456544·02 A None 

### 830.6313 Stability to nonnal & 

### N 

# • elevated temperatures, metals and metal ions. 

### 830.6314 Oxidation Reduction: 

### N chemical incomoatibilitv 

### 830.6315 Flammability
. 

### N 830.6316 Explodability N 830.6317 Stomge stability 456544·03 N No significant change 

### notedafterstorage **01** 54 

### + 2 C 

### for 14 days. Stability Testing at 3,6,9, 

# • 12, 18, 

### and24 

### montlts is 

### requiredfor full rellistration. 

### 830.6319 Miscibility NA Not a liquid at 20 C. 830.6320 Corrosion characteristics 

### 456544·03 N No 

### Significant change was notedafterstorage aJ 54 

### + 2 

### Cfor 14 days. 

### Corrosion Characteristics Testing 01 3,6, 9, 

### 12, 18, 

### and24 

### months ;s required fOrfull reJ!istration.

·8· 

# 182

# ..

Table 2: land

# ~ GLN 

### Requirement MRlD Stat- 

### Result or Deficiency
830.6321 

### Dielectric Breakdown NA Not Required. Not used Voltage 

### around electrical
.,n 7nnn 

### oH N 830.7050 UVNisible NA Not a liquid at 20 C,. 

### 830.7100 NA 

# INot a ,;, ,,;" IC. 830. N 

# •**.'~** 

### N 830.7300 

### Density/relative density/ N bulk 830.7370 

### Dissociation constant in N water 830.7550 

### Partition coefficient N (n-octanollwater) shake flask 830.7840 

### Water solubility: column N 

### elution method; shake flask method 

# • Solubility in organic 

### solvents
830.7950 NA : Nota liquid at20 C 1 

### A = 

### Acceptable; N = 

### Not .' _C,. 

### (see Deficiency); NA = 

### Not applicable.

### ~"'155°C" ,830:



### -9- 

# 183

# , :no"
. "1".'1 1 < 

### WA"K'N" 

### "A""C '6 ',',\''i.d\.lJllfi «. 101:;"**~I.:.J** 1'l' 

### (THUI Q 

## '2' ::1**~.** I ._**1."L'.~7** ,;;- 1
.... ; .. 

# ro**L7"l'i~I',7A'Z** - "**~** ..... . L.A) ;\

. __ Ii '\,1. ':
.. ; L



# •

• BOSTON tlftU5S£L5**CHI~ACO** fRAHKFIJI'IT tfAI'iDUttO**HO~G** KONO 

# ladlam 8.WOmBS ATrORNE:Y5 AT LAW**I.OHOO~** LOS ANGELf;S M.ILAN MOSCOW NEW JERSty

VIAFACSIIIfiLE 

### Freedom ofInfonnation Act Officer Freedomoflnfonnation Office (1105) 

### U.S. Enviromnental Protection Agency**l~OO** 

### P,ennsylvania Ave" N.W. 

### Washington, D.C. 20460 

### Tel: 

### (202) 566-1667 

### fm" (202) 566·2147 WMV,LW.COM


### Seplember 12, 2002 

# +OG(**t--&~** 

# C{PiS**\~Q-QjN ~OjjD**  '1- 0

# J.-- 

# d),tu; 

# \C/l02--

Re: Freedom ofTnformation Request 

### Dear SirorMadam: NEW 'fOAl( NORT)o(ERll VIRQIN1A

O"""NOC COUrffY PARIS**$A~** DIEGO SAt! FRANCUlCO 5.lLICON VALL(Y TOKYO W,l,SHIHQTON, O,C



### Purstl."Ult to the freedom of Information Act e'FOIA"), 

### 5 U.S.C. Seclion 552, and the 

### implementing regulations of

### the Environmenlal Prolection Agency ("EPA"). 

### 40 C.F.R. § 

### 2.100 

### et seq., I hereby request all 

### correspondence and other documentation related to 

### compliance of United Phosphorous, Inc., with 

### 40 C.F.R. Section 152, subpart E requirements for its 

### application for registration ofbifenthrin technical. 

### TIleSe documents include, but ate not 

### limite'd tOt EPA's 

### April 

### 25, 2002 leUer 

### referenced in the atta.hed leiter 

### daled June 3, 2002. J 

### also 

### request any 

### documents from EPA'5 

### Office ofGeneral COWisel, 

### or any other office, regarding EPAts position on the timing of submission ofoffers 10 pay compcnsalioo and/or certificadol1ll 'with respect to 

### citation ofdata
. I am not requesting any confidential business information (tlCBl"). If any of the documents 

### responsive to this requesr contain 

### CB

### I. please supply the documents with CBI redacted. We agree to 

### any necessary and 

### reasonable charges, which would not exceed $250.00, for obtaining 

### tills infonnation; otherwise, please 

### nolify me by 

### Ielephone al (202) 

### 637·1025. Wbenthe infonnatlon is available,**pl~e** 

### call me so Ican make arrangements for**pick~up** 

### or fax it to 

### me at (202) 637':'2201.**Th~)rou** 

### in Cldvo.nce for your assistanco.



### Attachments Respectfully submitted.

# ~=t) C. Felix Amerasinghe ofLATHAM&WATKlNS


# 193f

. 

# i ,

194

### -, -H"M ,. "A""" "A'" 

# 'c "

. rnO\! LA. In !(, II t

.....**,~** fI tr.!J 

### -tv "",.-,::: ;; \"L"O' 

### ,0**L-L~11~:":i:i.!'** '; ; , 

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

### .. ",. " 

### ..**~. ~** 



# •

• o .



# .**~)"ra]** UNITED STATES**ENVIRONt,tE~**.. "l'AL**PRC7ECn~t-.** t..GENCY 

### \.**~ ~.**  

# ..- "

....**-::.~.**



### United Phosphorus, Inc. 

### c/o 

### Ms. Elizalx:th A. 

### BroWD. Ph.D. ChemReg International; LLC 1990 Old Bridge 

### Road. Suite 20I 

### I.akelUdge, VA 22192-2383 Dear 

### Ms. Brown: SUBJECT: 

### Application for Registration Bifenthrin Technical Insecticide!Miticide EPA 

### File Symbol: 705()6..lU Your Resubmission Dated 

### May 8, 2002 C,:f.1CE OF PREvEN'nON PE51'1Cl0ES ANO rOXIC**SlJ~STANCES**



### EPA has reconslderedJts po,sition with**res~t** to 

### the subjtct a.pplication and determined 

### that the 

### application is inCOmpletefor the 

### =osgiven in the 

### Agency's April 25, 2002 

### letter: "An applic:ltion 

### is considered incomplete 

### ifany pertinent item specified,in §152.S0 has 

### not beensubmitted. Pur.runnt to §l52.50(0 

### an applicant must submit materials to demonstrate 

### thai he bas 

### ""mplied with FlFRA sec. 3(cXI)(D) and .ubpartE

### ofpart 152 (I'ro<c<Iures to Ensure

### Pro<ection ofData 

### Submittm' rughts). Tberefure, you mIlS! submit. completed 

### Certification With Respect to CitadooofDara(EPA Fonn 

### 8570.34) indicating,the Method ofDa.a Support you are using. You must also submit a list 

### of companies

# -s.mt offers of.compensation for 

### datn you are citing 

## iIi support ofthis 

### application.n We 

### reached Oul' decision aflu

### con:Nltation with at:tome)'5 

### in 

### the 

### Office ofGcneral C<JllDCiI 

### and

### theR<gis1m!ioliDivisioo's ...uormanagement I<!atll. 

### It was 

### agreed'that applications which 

### do not comply with the 

### data compcnsalion regulations atthe time 

### of submission will 

### be ""llSiderCd incomplete and 

### that 

### we will 

### not 

### spend resoW'CCS reviewing such 

### appliCiltions until 

### mater!a1s to 

### complete the 

### application have 

### been submitted. We 

### =gni2ethat you may have 

### been .uowed in Ibc past to submit 

### Ihesc maJeriaIs 

### later inthe reviewprocess. However, we 

### do 

### notbelieve thai this 

### pnoctice 

### is supported by

### the 

### n:gulations. The rqulBtion wbicbyou cite

### as allowing sUbmission>!. hucrpoint (40 CFR §152.114) 

### bas beenintetpr<ted to**m~** 

### that

### thcAgeney would notreject 

### an application9Ulljght if

### it

### is missing information on the 

### data compensation forms. The 

### regulation 

### does not envision

### thai an applicant 

### berequin:d to comply with 

### subpartEll!I!y a&r

### the

### application bas

### been 

### detemlinedto.be 

### accep!8ble for registration. Such a dctennhlatioD cannot

### be made until the 

### data compensatiOD requirements have 

### been met.


# 195

# •

• lTHU) 9. 

## :2' 02 !2:53 ST
..2:36**~O.** 

### 426]780743;J 4



# .'.
\',1:;;"**\(.l~ ~**  

## ::flt,: J;:tt..:t ::..;;,::. -':- I\',:\\nlirlll :h;H lil>!**.:uh.i~d Jprlj\.'~[li\ln**  ".'11' t"CC'I'
••••••• , • '", •• ' •• "' ':,,>1' ',. ,. . . \.\' j•• , •• ,. 

### 'r ""J" 1**~** ... , .., ,L, 'w'l J'

.....**'~'** '''-**,~** ...**~** •• ",

....... " ·\,-

..... ·F·

..'·\, \ Iw: •••**\'''oJ.'I.:,~**•• \,;_,;, "
... , \,;. 1;\,;

..,,'

....... ol

........ , ... I or draft 

### IJhd \\hich you 5ubmilll!rJ in .iuppon of rcglStr31ien 31lU \\111 tiel 

### bef:!ln**r~\I~\\'** ,,(

### tht::ot: 

### malerials until you submit the informalion requested above. Ifyou Mve any questions 

### teguding this action, please contact Susan StantoD ofmy team at (703) 305-5218.

George T. LaRooca Product Manager (13) 

### Inseclicide Branch Registration Division (7505C)



# 196

# •

• **1990** OLD BRIDGE ROAD, SUITE **201** LAKB RIDGE, VIRGINIA 22192-2383 DIIU!CT: 703-492"7905 1\LuN: 703-492-0445 Fax: 703-492-0668 

### ELIzAnEl'HA. BROWN, PH.D. 

### August 29.2002

DocumentProcessing Desk
· U.S. Environmentnl Protection Agency (7505C)

U.S. Environmentnl Protection Agency Room 266A. Crystnl Mall 2
· 1921 Jefferson Davis Highway
·Arlington. VA 22202-4501

Aim: 

### George LaRocca (pM 

### 13) E-MAIL: brown@cbem.reg.com WEBSITES: www.chem.reg.com 

### www.pesticide.net



### Re: Application for Registration ofBifenlrbin TecbnicallosecticidelMiticide. United Phosphorus. Inc. EPA File SymboI70506-RJ Agency Letters ofApril 25. 2002 and August 14.2002 Dear George: On behalfofour**clien~** 

### United Phosphorus Inc.• enclosed please find EPA Form 8570-34• Certification with Respect 

### to Citation ofData. United Phosphorus has 

### made the appropriate offers to 

### pay compensation. This 

### form is being 

### submitted at this 

### time in 

### orderto avoid any further delays in 

### the Agency's review ofthis application (filed April II, 2002) while the continuing issues associated with the reviSed-interpretation ofthe timing 

### ofthis certification in relation to 

### Agency review of applications for registration is 

### still being resolved. While we were reassured in the Agency letter ofAugust 14. 2002. that 

### the ahove application wa< not being treated 

### as withdmwn pending resolution of

### the issues, there has 

### been and will be 

### no progress in the Agency's review ofthe application pending such resolution or submission afthe appropriate certification. United Phosphorus will suffer economic hardship ifthere are significant delays in resolving the issues.

CONSULTANTS TO

### succESS"' Over OneHundred andFiftyYears of

### CombinedExperienceAssisting Chemical, Pesticide, Bio-Chemical and LifeScienceCompanies on a Wide Range ofIssues,IncludingRegulatory Strategies,Registration, Data Supportand Compensation, QualityAssurance, Study**~1Ul** 

### and ScientificMatters. 

## L U-I-------**--------~~----** 

### -- 

# --

---- 

# -- -- 

# --

---- 

### - --



# .. " 

# ..



# •

• Letter to 

### G. LaRocca, US EPA, August 29,2002, page 2 We still believe that as expressly permitted under 40 CPR 152.84 and EPA's Federal Register notice regarding thatregulation (40 Fed. Reg. 30884, Aug I, 1984), United Phosphorus is 

### allowed to submit a comp1eted CeI1ification with Respect to 

### Citation ofData 

### form to your office, and send the necessary data compensation offers to companies listeO on the data matrix, 

### atany time before registration is 

### approved. We believe that 40 FR 30884 is 

### correct in

### identifying that the Agency will

### not delay the review ofthe application pending receipt ofthese statements, but 

### will not approve the application until they are received and detennined to be in compliance. With this submission, we request that the Agency begin review ofapplication for registration submitted on Aprilll, 2002 by United Phosphorus, Inc. for Bifenthrin Technical InsecticidelMiticide (BFA File Symbc1705Q6..R1). It is our understanding that the appropriate 

### discussions should and will 

### continue regarding the issues ofthe timing ofsubmission ofsuch

. certifications for future 

### applications. Please Jet me.know if

### you have any questions.

Elizabeth Anne Brown
cc: United Phosphorus, Inc. TelispnrfPutsavage, Esq., Wright & 

### Sielaty, 

## p.e.



# 202

# oEPA United States Environmental Protectlon Agency

### ~------------------~I

Check Ifthis/s BnewBddrsss EPAAegNo. Product Namo 

# D Rosubmlsslco In responso10 Agency letter deted
___ _ Aoencv lettor dated 

# .0 "Me Too· Application 

# D Notification
- Explain below

Sub:mlssfon of Form 1:1750-34

Elizabeth Anne Brown 

# "[::1 Other
- Explain below I.

Yo. No Packagowgt

fntemaUona/, LLC

on this form end aU aUDehments tbereto ere true. aeeomtc aod tomplete.

mblcadlng nntement may be punishable by I'bw or tmprisonment or 

# "**C::::~lntornational.** LlC AI Agent
August 29, 2002 I Plastic Glass Paper Aolitrlcted

Othor (Specify)

(Stamped)



# 203" 

### , 

# ..
, , 

# ""**~l** UNrreD STATES ENVIRONMENTAL PROTECTION AGENCY 401 M STREET. S.W.

# ~:::;7 WASHINGTON, D.C. 20460 Paperwork ReducUon Act Notice: The public reporting burden lorthis collection ollnlormatlon Is estimated to averege 125 hours per respooso for roglslratlon and 025 hours por rosporlSO for reregistration and speclal review activlHes, Including tlmo for reading the Instrucllons and complatlng tho necessary fOf'lTlSo Send comments regarding burden estimate or any other aspect ofthis coIlectlon 01 Inlonnatlon. Includlng suggestlons for reducing the 

# I**~~to:** Dlroctor, QPPelnformatJon ManegomontDlvl8lon (2 t37), U.S. Environmental Protection Agency, 401 MStreet, S.W., Washington, DC
I ,ofData AppIIcant'sIAeglstrDnt's Name, Address, and Telephone Number EPA RGgfstraUon Numbet/Flle Symbol United Phosphorus. Inc. 70506-RI 423 RivlUVlow Plaza . 1 ropresontallvo tHtcompound(s)

## ~~~t: General ualng 40 CFR Part t5B) 

# l;lli**~** tlsl

### ~ano~1**~** on your label,you do not need 

# o I am rospondlng to a Data·CalI·ln Notice, and have IncJudedwlth this form a list of companies sent offers of compensatlon (Iho Data. Matrix form Should be lJS&d for this purpose). H, , c"lv) 

# 0 I am using the clto-all method 01 aupport, and have Included with

## ~ 11lf?_**u~ng** the eelecllvo mothod 

# ",',''.'" IhIs form a Hst of companies sent offew ofcompensation (the Dela- I "",,] 

## i'lom, Matrlx fonn ShOuld be used for this purpose) moo "" ",.d), I da

.. , 

# , (Required Ifusing tha cite-all method, Ofwhen uslng the clt&alI opUon undo!' the selective method to satisfy one or more data requirements)

## ~ I hereby oIfer and agree to pay com_lip", to o.ther persons. with regard tQ the approval ofthis appDcatlon, to the extent required by FlFRA

I, lorm tor reregistration or this Data-Call-in respenso Is supported by all data submitted 01 cited In 

### i.i ] ,orthe Data-CBll-ln response. In addition, Iftha Cite-Il!l option or cite-eli optiOn undar the Is supportmf by all data In the Agancy's files that (1) cOOCOl'n tho proportlns or effects 01 this 01 mote 01 the Ingrodlonls In this product; and (2) 1$ atypo 01 data that would be required to this application litho appllcallon sought thO II'l1t1a1 reglatl'Btion of a product 01 kfenllcal Of similar I certlly thatfor each oxcIuslva use study cited In IlUppoft ofthis rOillstroUon or rerOilJstnltlon, that I am tho original data subml1tar 01 that I have obtafned the written permission 01 tho original data submlttod 10 cite Ihat study. I certify that lor each sJudycited In support 01 this roglstraUon or rorOilI$traUon that Is not on exclusive use study, either: (0) I am the «Iglna! deta submitter; (b) I have obtained Ihe permlsslon of\he original dal.a submitter to usa tho sllldy In support 01 thls appllcatlon; (C) all periods 01 eligibility for componsaUon hiWo expired for thostlJdy; (d) the stUdy Is In tho pUblic literature; or (0) I have noUfiod Inwrlllng the compony that submitted tho sludy and have offered (I) to pay componsaUon to tho oxtont required bysectlons 3(C)(1)(F) and/or 3(C)(2)(B) 01 FIFRA; and (iI) to commence nogotlaUons to dotermlne the amount end tMITIS 01 compensaIlen.1I any. to be paid lot the usc oftho study. I cOrllfy that In aliinsiances whore sn offer Of compensation Is required, copies 01 all oflers to pay compensatfon and ovldenca 01 their convery In accoroame with sacHom;: 3(c)(1)(F) ondfor 3(e)(2)(B) of FlFRA are avaJlable and will ba subml11ed to the Agency upon request. ShQUld I lall to produce such evidence 10 the Agoncy upon requost, I understand that the Agency may InlUale action to deny, cancol or suspend Iha registration ofmy product In conformity with FlFRA. I corUfy thetthe statements I heve made on thls10rm and all attachmanto: to It are true. accurate. and complete. I acknowledge that ony knowingly fatse or mlaleadlng statement may be punishable by fine or Imprlaonmant 01 both under applicable law.

] 

### I

### ~~ust 29, 2002

## ;:~; I

# tL~ M, T1l1mW1 Technical**DII(~ctor** 

## ,",'-= 

# 204

# •



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



### United Phosphorus,lnc. clo 

### Ms. Elizabeth A. Brown, Ph.D. ChemReg International, LLC 1990 

### Old Bridge Road, Suite 

### 201 Lake Ridge, VA 22192-2383 Dear Ms. Brown: 

## AUG I4 

## axJ2

suafflCT: Application for Registration 

### Bifenthrin Technical InsecticideIMitiCide EPA File Symbol: 70506-Ri OFFICE OF PREVENTION, PESTICIDES AND TOXIC SUBSTANCES



### In

### "EPA's April 25, 2002 letter to 

### you regarding the subject application, the Agency indicated that 

### the application would be consideted adminislrativelywithdmwn if

### the 

### liated deficiencies were 

### not 

### correctedwithin 

### 7S days. 

## OnJune 

### 3, 2992, in

### reapanse to 

### your sulmtission ofMay 8, 2002, the Agency reiterated that it would not further review the above referenced application until the identified deficiencies had been corrected, but EPA did not at

### that 

### time indicate that 

### anew 75-day "clock" would commence following the June 

### 3'" letter. The Agency is in receipt of

### a June 27, 2002 letter on your behalffromTelisport Putsavage, Esq. with regard to those deficiencies. It

### is my understanding that 

### Mr. Putsavage 

### has also spoken with EPA General Counsel 

### staffrequesting thet UPI's application not be treated 

### as withdmwnpending the resolution of the concerns outlined in the June 27 letter and by other parties 

### regarding EPA review ofincomplete applications. By this letter, Iwish to 

### confirm that 

### EPA 

### will not treat the referenced application as withdmwn pending resolution ofthese 

### matters. Ifyou have any questions regarding this action, please contact Susan-Stanton ofmy tearn at (703)305-5218.

George 

### T. LaRocca Product 

### Manaser (13) Insecticide Bmnch Registration Division (75OSC)



# 205

# •



# •**---~~-------------**



### July 26, 2002 Patricia A. 

### Roberts, Esq. Associate Geoeral Counsel for Pesticides and Toxics U.S. Environmental Protection Agency Office of

### General Counsel 1200 PennsylvaniaAvenue, NW Washington, DC 20460 R.: Off
.... to Pay for FoUow-on Registrants Dear

### Ms. Roberts: On 

### behalfof!be Cbemical Producers and DistrIbutors Association (CPDA), I am 

### writing 

### to you concerning EPA'8**long~s~** 

### policy ofallowing lime-too" or generic registrants to submit a Certification with Respect to Citation ofData (EPA Form 8570-34) "at any iater time 

### prior to EPA's approval of!be application." 40 CFR 

### §152.84 Byway ofbeekground, CPj)A is a voluntary, nen-profit organization ofabout 90 companies engaged in !be formuIation,' manufucturer, diatribution, and sale ofsome $6 billion wortb ofgeneric products used 

### on food, feed, and 

### fiber crops and inthe care of lawns, 

### gardens and 

### turf. Many ofourmembees are involved in the development and sale of adjuvants and inerts 

### used to increase !be efficacy ofcrop protection formulations as well as a variety ofcopper-based pesticide products. As 

### such, EPA rules, regnlations, and guidelines a1fuct ourmember companies significantly. For !be pest 

### eigbteenyears and until vary recently, Agency practice bos been 

### clear, and interpretation of!be applicable regnlations bos been coasiatent. 

### The Agency promulgated the final 

### rule entitled Procedures to Ensure Protection ofData Submitt
....' Rights, 40 CFR §152.80 et 

### seq., 

### on August 1, 1984. See 49 Fed. Reg. 30,884. That

### rule took effect on April 

### 25, 1985.**~** 

### 50 Fed. Reg. 16234. Section 40 CFR 

### §152.84 states: AU informationrequired by 

### this 

### subpart sbould be submitted with the applicalion, but may be submitted III !lIlY 

### Wet

### time prior to EPA's approval of!be Qpplication. 

### The Agency 

### will not .pprove 

### acy application until it determines either that the application is not subject to these requirements or that nll

### required materials have been

### submitted and are acceptable. (empbosis added) In addition, !be Preamble to !be AUgust I, 1984 pUblication entitled Agency Review to Determine Compliance clearly discusses in Section VII the Agency's interpretation ofits policy, and specifically clarifies both !be timing 

### ofan applicant's


# 206•



# • Patricia A. 

### Roberts, Esq• 

### Page I of5

registration and 

### the timing 

### of the 

### submission ofa Certification withRespect to Citation ofData. The 

### Preamble unequivoca1ly 

### states: Under F1FRA section 3(c)(5)(B), the 

### Agency must review applicatinns to determine whether

### the 

### materials required to be submitted, including those that 

### are required by 

### this 

### Subpart E, comply with 

### the 

### requirements ofthe AC!. This part 

### of the 

### review need 

### not take place before tbe Agency begins 

### to review the application for compliance with other statutory requirements, but must occurbefore the registration is approved. EPA recognizes that 

### the correspondence requirements ofthis 

### subpart may take some time, and 

### that an applicant may not wish 

### to await responses in all 

### cases before filing 

### his 

### application. Anotable example is data gap certifications: if

### a data

### gap is suspected, the 

### applicant can not claimthat the gap 

### exists until 

### be baa 

### waited 60 days after correspouding with 

### data submitters. EPA sees no reason why correspondence times and 

### Agency review times maynot run concurrently. Section 152.84 therefore provides 

### that appliconts may 

## submit materials ""mire<! by

### this sYboort !II 

### any time before regis!ratinn is !!!l!!lIed. The Agem;y

### will 

### rot delay the review of 

## otherjnfu!llll!tionpertinent 

### to the 

### IlPnlication pending receipt ofljsts and 

### certiticatinn Iil!\tements; 

### but 

### will not IlPprove the registratinn until they are received.
. Applicants should be aware, however, that if

### deficiencies are found in 

### materials submitted hae in 

### the 

### Agency's review, 

### the 

### registration could be delayed while the 

### applicant corrects tbe problem. If the Agem;y 

### completes its 

## review ofthe _cation. 

## but has not received the IlPnlicant'. submisaions 

## 1IJ1derthis rule. the Agem;y

### will send the 

### applicant a reiection letter. whjcb 

### will include a 7S-dav re:monse 

### time, after which the 

### IlPPlicalion winhe treated as though 

## it bud heen withdmwn. A new application will 

### be required if 

### the 

### applicant wants to pursue registratinn at some haer date. 49 Fed. Reg. 30884, 

### at 30897
. (emphasis added) Despite the 

### cwly-worded Preamble 

### and EPA's own regahaions, it appears that the Agencyis

### reconsidering its

### poficy of the last 

### eighteen years. We 

### at CPDA strongly nrge the 

### Agency to 

### retain its long-standing interpretation ofits regu1ation. The 

### implications ofapotential policy shift 

### are enormous. First, rather 

### than 

### expediting the 

### registration process und using fewer Agency resources, the 

### policy change would slow 

### down the 

### registrationprocess, eneournge delays and 

### additional review, delay entry ofgeneric products to the 

### marketplace and 

### decrease competitinn. Such a shift 

### would result insevere, 

### direct negative economic impacts on 

### fimners, ranchers. consumers, and 

### pesticide consumers. Second, by 

### requiring "me-too" registrants to make 

### data compensation offers to 

### pay priorto processing ofpestieidc applications, the 

### "extra" eighty-to-ninety days will 

# 207

# -



# •

• Patricia A. Roberts, Esq. 

### Page20fS

give the 

### original data submitter additional time to file petitions to deny such registrations sad 

### provide more 

### lead time to file a

### petitionto cancel once EPA has 

### approved the 

### products. The 

### proposed poliey change will 

### create an 

### incentive for frivolous petitions to deny, designed to stall the 

### process. 

### In the 

### meantime, Agency stalftiote will 

### be diverted to process the 

### petitions. Third, 

### rather then 

### saving EPA resources, more 

### stalftime sad 

### resources will

### be required while the 

### approval process for "me-too" or generic products will be slowed down. Fourth, if

### EPA insists onthis new interpretation ofSection 40 CFR §152.&4, the 

### Agency will 

### experience an 

### onslaught of petitions to cancel registrations previnusly grantad uader

### tbe "old" interpretation ofthe 

### reguiations. These 

### chsl1enges to existing reguiations could be besed upon untimely oflCrs to pay. These 

### appeals would also 

### consume more 

### EPA time sad

### resources.. Fifth, the language in the 

### reguiation

- "at any later time" is unamhigoous. Ifone argues that 

### the 

### offerto pay must be submittad with the 

### applieation, it 

### would completely undermine the clearlanguage sad 

### intent of the 

### reguiation. Ifthe 

### Agency is considering a

### change to 

### the language 

### of40 CFR § 

### 152.&4, the 

### Agency should comply with the 

### Federal Administrative Procedures Act (S U.S.C. §S51) by giving 

### poblic notice sad seeking 

### public comment All 

### affected parties 

### should have an opportunity to review sad 

### connnent onaproposed change to the reguiation. We at CPDAurge the 

### Agency to retsin its long-staading interpretation of40 CFR §152.&4, sad dismiss 

### otherEPA efforts

### to uadermine

### sad 

### alter the 

### clearintent oftbe reguiations. Moreover, we at ePDA strongly support the letter from 

### Telisport W. Putsavage of Wright & 

### Sielaty, P.C., to you dated June 27, 2002 conceraing this same matter. As 

### this issue affects huadreds ofgeneric registrants, we request a meeting to discuss this importaut issue. Very

### truly yours,



### Warren E. Stickle, PhD. President
eo: Marcia Mulkey Jim 

### Jones Debbie Edwards George LaRocca 

# 208

### PatriciaA. 

### Roberts, Esq. 

### Page 3 or5 •



### Micbelle Knorr



# •

•

209

# . ,



# •



# • 07123/2002 16:12 703-492-0066 -"IGHT & 5IELATV PC 

## WRIGHT 

# &: SIELATY, 

# P.C. COUNSELORS AT LAW 1990 OLD BlUDGI! ROAD, SUITI! 202 LAJ<B RlJ>GB, VmGINlA 

### :Zlga-R3Sa PAGE 01

TELlBPOllTW. PUTSAVAGB DJUcT: 703-492-0788 PRomu 703-49J1-0055 a-MAlL: 

### putaavaae8ohomlaw.com



### FMMI!SSAGE DATE: July

### 23, 2002 TO: 

### George Larocca FAX: PHONE: PAGES: 8 

### (Including Cover)

. MESSAGE, FAXf 70S·...gs·oo66 WEll 

### www.ohemlllw.c:om



### 703-605-1225 703·305·6100



### THIS WILL BETHE ONLY FORM OFDELIVERY OFTHIS DOCUMENT

PPFICES NEAR. WASHINGTON, D.C., AN!) IN ALBANY, NEW Yon 

# 210

### •



# • 01123/2002 15:12 703-492-0066 toRIGHT & SIELATY PC 

# WRIGHT&SIELATY COUl'4Sl!:LORS AT LAW 199'0 O1on BaIDGE RO,.lD LAD ruDGE, VIRGINIA 22191..30Z6

TSLISPORT W. !'UTIiJAVAGE 703.49z.o738 FACSIMILE 703.4'2.0066**puts"~.com** PAGE 02

. .Allo at **ADNITT.D iii**  **Y8W** 

### ro.r **.eND JI.f/(fLAHD**  **Nor A.DHlr78D**  **IN YI.al11U**  One Steu.ben Place, Sqlte 5 ..llbany, Now Yo'rk 12-107


### By

### Facsimile and

### OvernightMttIL PatriciaA.

### Roberts, Esq• 

### Associate General Counselfor

### Pestidclea and

### Told", 

### Offlee 

### 01 General

### CotmseJ 

# U.s. EnviIotunental Protectlon Agency 

### 1200Pennsyl..ruaAvenue, NW Washlngton,DC 2000 

### July 23, 2002

RE: Applicationf9r Regis1ration

### ofBifenthrlnTeclmkalhlSecticide/Mitidde 

### United Phosphorus,

# me., SF A File Symbo170506-RI Dear

### Ms. Roberts: Iwrite

### to

### you in

### lin1horregBJ;dto 

### 1hetiming

### of o!l'<:uto

### pay:datacompeosation1hetIxalsedin my loiter 10 

### you ofJunt27,2002. 

### 'l11atletter 

### addressedthe issu.

### xal,ed in• letter

### ofJune3, 2002 

### from Mr. George 

### LaRoeca, Product Manager 13 in 

### the Inecticid. Br.mch 

### ofthe Rogislration 

### Division in

### the 01!lee ofPcaticideProducts. to 

### Dr. Elizabeth lIro)vn 

### ofChemReglAtemotional
.. agent

### for

### UnitedPhosphorous,

### Inc. ("UP!"). 

### Ihadrequested 

### 1het1heAgcnoy

### rescind 1henotice 

### of luoe3,2002

### fromMr. LoRocc&and 

### continueto_,thoapplication;;,question, orin

### the abscn", 

### ofa 

### rescission, that

### you edviseme inwriting 

### of1he1 fact 

### and whether 

### suchrefusal- is 

### final agency action on this matter. To 

### dateIh,v.received noresponseto my

### letterormylelephonefollow-II\'. I,uggestthaI 

### if 

### theAgencyrequires lin1hOftim.10 

### .-.viewits

### positiononthis subjectthat it 

### nonetheles. proeecd 

### to process 

### the referenced application for 

### regis1rntion. Sine. 

### the policy 

### in question at th.least has 

### not been 

### uniformlyappliC<i, and 

### given the 

### widcspreed lack 

### ofinductry awareness ofthe policy, it

### would "'em equitable 1het tho poliCY 

### be applied to new 

### .pplicatioll! 

### following an announcerocnlto

### regulstedcommnottyof theAgency's

### position. Underthls epproaoh, 

### the application in 

### question could continue to 

### be processed.

'APROFEl9SlONAL CORPORATlON WlTB OmOESN!lAR "WASHINGTON', D.O., AND INALBA.."f)', NEW 'YORK 

# 211

# •

• 01123/2002 15: 12 793-492-0066**~IGHT** & SIELATV PC



## WRIGHT 

## &: SIELATY., 

# P.C.
PatriciaA. 

### Roborts, Esq 

### July 23, 2002 Pag.Zof2 PAGE 03



### If

### we are unable 

### to be assured that om client'. rlgh1s 

### are being 

### protooted 

### in the CUll'OIlt 

### oircumstances, omolientwillbelbreedto COllIiderwhot

### avmu08 of Ie

## salrccomse arc available: It 

### wouldbe 

### anunforIunate waste

### ofthefCSOmces ofbothoUfeli.."tandtheAgencyifwewereforced to pUIlIUe 

### olb
... opuo,", oimply to 

### presetVe the ststus 

### quo in 

### the abooncc of._efrom 

### the Agency.

cc: 

### Verytrulyyot11'9,

# -1~lJr~ TellsportW. PufBavage

. 

### Ms. MarcIa

### Mulkey.DIredor. 

### O£fkeofPesticldeProducts Me.

### DebbIeEdwards, Acting

### ?frector. RegIstration

# DIVisIon Me.

### DeboxahMcCall,lNectidde Branch, 

### ReglstmtionDivlaion 

### Mr. 

### George LaRoca,Product

## Manager. IngecIicide BIIl!1Ch 

### Midu!Ila

## Knotr, 

## Esq. Pestlcldes andToxic

### Substances L<owOf/ioe 

### Mr. Jeffrey

### S.Prltchanl,UnitedPhospborus 

### Inc.



# 212

# ----------_

... -.



### ,


# ,



# •

• 07/23/2002 15:12**7e3-492-0a~6** 14<IGHT & SIELATV PC PAGE 04 

# WRIGHT&SIELATY

TELISPORT lV. l'UT8.VA&:E 703.492.0738 FACSIMILE 703.492.0066**prnt~@dttmIaw.com** Abo at A.IJNI1TRIJINN."**rD~1(** "ND Jt.4Al£AHIJ NOTADNlTTZDIII VIJ((JIHIA. . 

### 0.0 Steuben I'laee, S.ite 5 Alb.. )', Now YOl'k**12~07**



### ByFacsimik

### and Overnighf

### Mail Patricia

### A. Roberts,

### Esq
. June 27, 2002



### Associate General

### Counsellor

### PestiddesandToxiC! U.s. Environmental Proteetion

### Agency Officeo/GeneralCounsel 1200PennsylVllIrla

### Avenue, NW WBBhinglon,DC

### 2Il4.6O RE: Application for

### Registration ofBifentrhin

### TechnicalInsectidde/Mitidde,
. UnitedPhoaphorus, Inc., 

### EPA File 

### Symbo170506-RJ o"ar

### Ms. Roberts: I write to

### you in 

## response to aletter of

### June 3, 

### 2002.from Mr. George LaRocca, 

### ProductManage.r 13

### inthe!:nse<tlddeBranchofthe

### RegistrationDlviBloninthe

### Officeof PesticideProducts,

### toDr.JlllzabethBrownofChemRegIntemationaias 

### agentforUnited Phoaphorous,Inc. ("UPl"), 

### a

## copyofwhichlsattached. ihavea\sodisalssedthismattar 

### withMs. 

### Michelle 

### Knorr of

### your office. Inh1sJi.me 3,2002IettarMr.LaRoo:astatesthatthe applicationreferencedabove is

### incomplete and willnotbeprocessedbecause aCe.rtlficationwlthRespect

### to Citation of Data (EPA Form 8570-34) was not included with the applkation. However, in submittlng this 

### application on April 8, 2002, 

### Dr. Brown had requested 

## that slu! be
. notified 

### upon completion ofthe

### review of application, at which time the CertifICation would be 

### submitted. Thispract!ce, whlchMr. LaRocca statesthatheisnowrefusingto 

### follow, 

### acconds with pastAgency practice and the 

### applicable regulations
.

.A. PltOf'ESeIONAL OORPORATIOM WITH On'lOJtSNEARWASHlNGTON, D.C., A.ND IN' ALlJA."O!'. NEwYORK 

# 213

### ,



# • 07/23/2002 15:12 703-492-0966 ORIGHT • SIEi.ATV PC PP/3£ BS •


## WRIGHT &; 

## SULATY, 

# p.C. PatriciaA. 

### Roberts, Esq 

### June 

### 27, 2002 

### Page 2 ofS 

### Mr, LaRoccaalareo

### thatupon advice 

### ofthe

### Office of

### General Counsel and

### WIlor 

### managementin theOffice 

### ofPesticidePrograms: 

### The

### regulation

### ,,!hichyou dte

### as aIlowirlg submlssion.1 alaterpolnt(40 CFR §152.84) 

### has beenintetprered 

### to 

## mean that the 

## Agency would not reject 

## an application 

### outright if 

### it is 

### missing information on the data compensationforms. The

### regulation does notenvisionthatan applicant oomply withaubpart E 

### [40 CFR·§152.80 

### etseq.lllllbl afterthe

### application has been determined to be ae<:eptable for 

### registration. Such. determination cannot

### bemadauntil

### the data

### oompensationrequirements have been

### met (emphaslsin theorlgina1) This 

### position represents 

### a major change in the Agency's approach and interpretstion of

### regulationa applicable 

### to the prooessJng ofregistration applications dtingthedotaofotherregistronts. Webelievelhatthischangehasbeenimplemenredin violation ofthe

### Federal Admlnlstrative 

### Procedure 

### Act, 5U.S.C. §SS1 

### at

## seq., in thaHt represents a change to 

### an

### e>dsting rule thaiwas

### made withoutbenelit of

### public notice and 

### comment. The

### Agencypromulgaredthe

### 6nalrule

### entitledProcedures to 

### 1!nsureProtection of Data Submitters' Rights, 

### 40 CFR §152.BO et 

### seq., on August 1, 1984. 

## SJ:l: 49 Fad. • Register 30,684. That

### rule took efrect

### onAprU 25, 1985. 

## SJ:l:50 

### Fed. Reg. 16284. 

### Section40 CP.R, §152.84 states: 

### All information 

### required by this subpart should be submitted wiili ilie application, but IIla)t 

### be Stlbroltted at 

### any 1M lime prior to 

# EPA'. approy;!l of

### the application. TheAgency willnotapprove anyapplication until 

### it determines either that the application is 

### not subject to these requirements or that aIlrequlred maler\ais have been aubmltted and are ae<:eptable. (emphasis added).



# 214

# •

• 07/23/2002 15:12 703-492-09&&**~IGHT** & SIE1..ATV PC PAGE 06



## WRIGHT "**$IELATY~** 

## P.c. PatriciaA. Roberts. Bsq June 

### 27. 2002 

### Page30f5 In our 

### dlscu$sion of 

### thls matter. 

### Ms. Knorr argued thel the Agency is 

### free 

### to iIlterpret the phraae "at any later time prior to 

### EPA's approval ofthe application" to 

### mean at

### the timethe applicationlsfiled. 

### andthetdespiteour

### ""Perience to theoonl7ary. has tonSistently done 

## so. Thls 

### positiondirectly 

## contradictsboththe ""Press text of40 

### C.P.R. §152.84 

### and

### the Agency'. hlstoriciIlterpretation ofthe rule.
. To argue that the phrase "at any later time» 

### can be 

### applied to mean that the cerlifi.cationmustacoompanythe applicationrendersthepermissive

### phrase "shouldbe 

### submilied with the application" m.aningl
.... Thls 

### position not only defies 

### standard reguiatol)'Interpretationprinciples.bu.t 

### ""Presslycontravenestheposition

### takenby

### the Agency In promulgating the rule 

### In question. In

### Section

# vn 01 the Preamble of the August 1. 1984 

### publication, entitled Agency Review 

### to Delermil\e Compliance, the Agency spelled 

### oulltsapproachto the timing ofan applicant'sregistrationapplication In relation to the submission of a Certification with Respect to Citation of 

### Data. The Preamble stales: 

### Under FIFRA section 

### 3(c)(5)(B). 

### the Agency must review 

### applications.to determInewhetherthemalerialsrequired to

### be submitted,includIng

### those that are required by 

### thls 

### Subpari E, comply with the requirements of 

### the 

### Act. This parto£**themiewIl~ed**

### not**takepl.cebe£orefueA~besIDs**

### to 

## review the 

### APPllo;alion for coml'lii!llC!l 

## willJ. 

## other slatutm;r

### requirements, 

### butmustog;urbelorethere&!Blranonls

### IIWroved. BP Arecognizes thetthe correspondencerequirements ofthls subpart

### may

### take some time, and

### that an applicantmay not

### wish 

### to 

### awaitresponses In all 

### cases before filing hls application. A 

### notable example is 

### data gap certifications: 

### If• 

### data gap is suspected. 

### the applicant can not claim 

### thel the 

### sap exists until 

### he has wailed 

### 60 

### days after corresponding with data submitters. 

### BPA
.... no reason why correspondence times and 

### Agency review 

### tim
..maynotrun 

### concurrently. 

### Section 152.84thereforeprovidesthat

### ap.plicanlli

## miIy

## submit materialsrequired by

### this subpartMon.v**timebefore~tlon** 

### Is

## smnted. The 

### AfI!ID!;Ywill

### not

### delay the 

### reviewof

## otherInIonn_tion

## pertinentto the 

## APPlicatioxlpendlnS

## wceiptoflimi1Dd certificationstalemenlli.

## butwill

### not**~** 

### the 

### feils!ration un!llfuey 

### are recejygd.



# 215

# •

• 67/23/21)02 15: 12 703-492-0B66 WRIGHT & SIELATV PC PAGE 07



# .. WRIGHT" SIELATY, P.C. Patricia A. 

### Roberts, Esq June

### 27. 2002 

### Page4of5 Applicants $hould be 

### aware, however, that if 

### deficiencies ate 

### found in materials submitted

### lateinthaAgency'B WIiew, 

### theregistr.tioncouldbe 

### delayedwhilethaappllcantcorreCl!!theptobIem.l:ftha

### agencycoml'Jetea !Is 

### ttview 

### of tha i\I'Ifllglion. but 

### has not J1lQ!lyed 

### tb!l WpliCllllt'. 

### submip!oNJl!)dl!t

### t:bls

## rule.theAeon£)'willftend 

### thai\I'Ifllcant.

### rejection 

## letter. 

## which will Include a 75-<1ay rt,I,IlOM 

## tim.. after 

### which tha 3}lplication will be 

### treated 

## as thOllsh It had 

### bHn 

### wi!hdrlll'llJ. A new 

### applicationwill

### berequired 

### ifthaapplicantwantstopursueregistrationat some 

### later date. 491'ad. 

### Register**~** 

### at30897. 

### (emphasis added) Given

### theexpress

### lennoftheruleandEPA'.foanally-expreosedlnterpxetationof it

### thalmplementatlonoflhecontwypositionexpressed

### byMr.LaRoccaandMs. 

### Knorr would requirepromulgatlonofanamendmentoftharuleptn'8uanttotheprocedutesof the Adminisirative

### procedure Act TheAgency'spositionisnolonlyinconlravention.oftheruIebutID-advisedona policybasfs. Byrequiringdata-<:iterstomokeofferstopaypriortothaprocessingoftha applicatioxotheAgencywillinvirenumerouspetilionstocanoelwhllesuchapplications arebeingprocessed,lharebyburdenlngboththaAgency and 

### applicantswllhadditional delays 

## inprocessing 

### applications. In

### addition, if

### theAgency insists 

### upon pursuing

### its 

### new intelpretation, counaellor several data submittershave already informed us that ·they would puroue 

### challenges to existing 

### registrations for which offers 

### to pay were 

### made after

### Ihe Agency had camplered applications 

### reviews. These attacks would 

### b. premised upon 

### arguments that tha Agency granted regl!t:rations without complete applications andbasad

### uponuntimely offers to pay. 

## rrequest

### thatthaAgencyrescindthanoticeofJune

### 3,2002fromMr.

## I.aRoccaand continue to

### processtha applicationinquestion. Uponcampletionofthareview;

### UP!will 

### providelhenecessarycertificationconfirmingthatanofiertop.ylhedatasubmitter(s) has 

### beenmade.
.



# 216

# •

• 51123/2e02 15:12 703-492-0066 IoRIGHT & 5IEl..ATV PC PAGE 

## e. • •


## WRIGHT 

# A SIELA'rY, 

# P.C. Pattlci.A 

### Roberts. Esq 

### lune27,2002 PagoS 

### ofS 

### IftheAgency

### refusEs to

### rescind 

### theJune a-inotice,

### pl~inunedia~yadvise".. inwriting of

### that fact 

### andwhether such refusal

### Is fina1.geney acliononthis

### matter. In such 

### circw:nstances, 

### UPI resexves the right to

.. 

### ek 

### an injw)ctlon in 

### federal 

### coUrt to

. 

### compel EPA to 

### complywith the proceclura1requirementa setforth

### in

### the 19B4Federal Register. 

### Very

### tru1yyours,

# ~01t.v.**fuf~~**

.Te!isportW. Pulsavage Ms. Marda

### Mulkey, Director. 

### O£f!ceofPestiddeProducts Ms. o.bbie Edwards,ActingDirector,

### RegIstration Dlvlslon 

### Ms. Deborah**~** 

### InsecIid.deBnnch;

### RegIstrationD!vlslon Mr. 

### George

### I.aRocca.ProductManager, InsecIid.d.

### Branch MicheJleKnorr, 

### Esq, Pestid.d

..and

### Toxic

### Sub_Law 

### O£f!ce JetlIey

## s. Pritdultd. Unitedl'hosp","",J'no,
.



# 217

# -----------------**---~-** 

### t3!l!or,e- 

## LArrxCA ?/I.o? 

# • 

# I '



# •



# • ..

, c 

# WRIGHT&SIELATY COUNSELORS AT LAW 19.90 OLD BRIDGE ROAD LAKE RIDGE, VIRGINIA ZZ19Z-3026 703.492.0738 FACSIMILE 703.492.0066 puJstn'age@Chemlaw.com TELJSPORT W. PUTSAV AGE Also at



# . A.DMJTTED IN Nzlf' YORK AND MARYLAND NOTADMITTED IN Y'JItGINIA One Steuben Place, Suite 5 Albany, New York 12207



### By

### Facsimile.and OvernightMail Patricia A. 

### Roberts, Esq. June 27, 2002

Associate GeneralCounselforPesticides andToxies US. EnvironmentalProtection Agency Office ofGeneral

### Counsel 1200PennsylvaniaAvenue, NW Washington. DC20460 ••• • 

## • •

••


### • 

# · 

# .. •• •



### •••• 

## • •••• 

## • •

•••• 

# .. 

# . ., 

# . · 

# .. RE: Application for Registration ofBifentrhin Technical InsecticidelMiticide, United Phosphorus, Inc., EPA I'ile Symbol 70506-Rf
. DearMs. Roberts: 

### •••••• 

### • 

### •• • • •

### ••••• • •



# .. ••••• 

## • • •••••

I write to you In response 

### to a letter ofTune 3, 2002 from 

### Mrc George LaRocca, ProductManager13intheInsecticideBranch

### oftheRegistrationDivisionintheOfficeof PesticideProducts,

### toDr.ElizabethBrownofChemRegInternatibnalas agentforUnited Phosphorous,Inc. ("UPI"), a copyofwhich

### is attached. Ihave 

### also discussed

### thismatter with Ms. Michelle Knorrofyour office. Inhis

### Tune 3, 2002 letter

### Mr. LaRocca states that the applicationreferencedabove isincompleteand

### willnotbeprocessedbecause a CertificationwithRespecttoOtation of Data (EPA Form 8570-34) was not included wiU, the application. However, in submitting 

### this application on April 8, 2002, Dr. Brown had requested that she be notified upon completion ofthe review of application, at 

### which time the Certification wouldbe submitted. 

### This practice, 

### which

### Mr. LaRocca states that he is nowrefusingto 

### follow, accords with pastAgency practice and the applicable regulations.

A PROFESSIONAL CORPORATION WITH OFFICES NEAR WASHLVGTO:-.1, D.C., A.;."ID IN' ALBA..?.:Y, NEW YORK 

# 218

# ,



# •

• WRIGHT 

## &: SIELATY, 

# P.C. Patricia A. Roberts, Esq 

### June 27, 2002 Page 2 ofS



### Mr. LaRocca states thatuponadvice oftheOffice ofGeneral Counsel and senior management in the Office ofPesticidePrograms: ThereguJation whichyou cite as allowing submissionata laterpoint (40 CPR §152.84) has been interpreted to mean that the Agency would not reject an application Qutrig:ht 

### if it 

### is missing information on the data 

### compensation forms. The regulation does not envision that an applicant comply with subpartE [40 CFR §152.80 et seq.]**~** 

### after the application has been determined to be acceptable for registration. Such a 

### determinationcaru19tbemadeuntilthe data compensation rf7quirements havebeenmet. (emphasis in the original) 

### This position represents a major "change in the Agency's approach and interpretation of reguJations applicable to the processing 

### of registration applications citingthedataofotherregistrants. Webelievethatthischangehasbeenimplementedin violation of the Federal Adininistrative Procedure Act, 5 U.S.c. §551 et seq., in that it represents a changeto an existing rule thatwas made withoutbenefit of publicnotice 

### and comment. TheAgencypromulgatedthe

### final ruleentitledProcedures toEnsureProtection of Data Submitters' Rights, 40 CFR §152.80 et seq., on August 1, 1984.**~** 

### 49 Fed. Register 30,884. That rule took effect on April 25, 1985. Sgg 

### 50 Fed. Reg. 16234. Section 40 C.F.R. §152.84 states: All information required by this subpart should be submitted with the application, but may be submitted at any later time prior to EPA's approval ofthe application.The Agency

### willnotapproveany application 

### until it determines either that the application is 

### not subject to these 

### requirements orthat 

### all required materials have been submitted and are acceptable. (emphasis added).



# 219

## •



# •

• WRIGHT 

# It SIELATY, 

# P.C. Patricia

### A. Roberts, Esq June 27, 2002 Page 3 

### of5 

### In our discussion of this matter, Ms. Knorr argued that the Agency is free to 

### interpret the phrase "at any later time prior to EPA's approval of the application" to 

### mean at the time the applicationisfiled, and that despite our experience to 

### the contrary, has 

### consistently done so. Thls 

### position directly contradicts both the express text of40 C.F.R. §152.84 and the Agency's historicinterpretation ofthe rule. To argue that the phrase "at any later time" can be applied to mean that the 

### certification mustaccompany the .application renders the permissive phrase"shouldbe 

### submitted with the application" meaningless. This pOSition not only defies standard regulatoryinterpretationprinciples,butexpresslycontravenesthepositiontakenbythe Agency in promulgating the rule in question. In Section VII of the Preamble of the August 1, 1984 publication, entitled Agency Review to Determine Compliance, the Agency spelled outits approach to the timingofan applicant's registration application in 

### relation to the Submlssion of a Certification with 

### Respect to Citation of Data. The Preamble states: Under FIFRA section 3(c)(5)(B), the Agency must review applications to determinewhether the materialsrequIred to be submitted, includingthose that are requIred by this SubpartE, comply with the requIrements of the Act. ThispartofthereviewneednottakeplacebeforetheAgerl!;ybegins 

### to review the applicationfor compliance

### with other statutory requirements• butmustoccurbeforethe 

### registrationisiij>proved. EPArecognizes thatthe correspondencerequIrements ofthis subpartmaytake some time, and that an applicant may notwish to awaitresponses in all 

### cases before filing his application. A notable example is 

### data gap certifications: if a data gap is 

### suspected, the applicant can not claim that the gap exists 

### until he has waited 60 days after corresponding with data submitters. EPA sees no 

### reason 

### why correspondence times and 

### Agency review times may not run concurrently. Section 152.84 

### therefore provides that applicants may submit 

### materials reqyiredby 

### this subpartatany 

### time before registration is 

### &ranted. The 

### Agency Will not delay the 

### review ofother information pertinent to the 

### applicationpending receiptoflists and certification statements, butwill

### not approve the 

### registration until thgy are 

### received.



# 220 '-------------------------

### • /<



# • • 

# WRIGHT & SIELATY, 

# P.C. Patricia A Roberts. Esq June 27. 2002 Page 4 of5 Applicants should be aware l**however~** 

### that 

### if deficiencies are found in 

### materials submittedlateinthe Agency's review, theregistrationcould be delayedwhilethe applicantcorrectstheproblem. 

### If

### the agencyccmpletes 

## its review af 

### the a:pplicatiQn, but 

### has not received the apl'lic.m'§ submissionsunderthisrule, the Agency willsendthe applicant arejection letter. which will include a 

### 75-day re:;ponse time. after which the application will be created as though it had been withdrawn. A new application willberequired if

### the applicantwantstopursueregistration at somelater date. 49 Fed. Register 30884, at 30897. (emphasis added) Given the express

### tennoftherule andEPA'sfonnally-expressed interpretationof it, 

### the implementation ofthe contraryposition expressed by

### Mr.LaRoccaand Ms.Knorr wouldrequirepromulgationofanamendmentoftherulepursuanttotheprocedures of the Administrative Procedure Act. TheAgency'sposition

## is notonlyin contraventionoftherulebutill-advisedona policybasis. Byrequiringdata-dters to makeoffeFS topaypriortotheprocessingofthe application,the Agency will<invitenumerouspetitions to cancelwhile suchapplications arebeingprocessed, therebyburdeningboththeAgency and applicantswithadditional delays inprocessing applications. In

### addition, if

### the Agencyinsists upon pursuingits newinterpretation, counsel for several data submitters have already informed us that they would pursue challenges to existing registrations for which offers to pay were made after the Agency had completed applications reviews. These attacks would be premised upon arguments that the Agency granted registrations without complete applications and based upon untimely offers to pay. ] requestthat the Agencyrescind the notice o£June 3, 2002from

### Mr. LaRocca and continueto process the applicationinquestion. Uponcompletionofthereview, UP] will 

### provide the necessary certification confirming that an offer to 

### pay the data submitter(s) has beenmade.



# 221.' f



# .. WRIGHT 

# a SIELATY, 

# P.C. PatriciaA. Roberts, Esq June 27, 2002 PageS ofS 

### IftheAgencyrefusestorescindtheJune3'" notice,pleaseimmediatelyadviseme inwriting of thatfact andwhethersuchrefusal

### is final agency actionon 

### this matter. 

### In such circumstances, UPI reserves the right to seek an injunction in federal court to compel EPA to comply with the proceduralrequirements set forthin the 1984Federal Register. 

# liZ:;;s,4(

# fuf~J!k- Te1isportW. Puts.vage

cc 

### Ms. MarciaMulkey,Director,Office 01 PesticideProducts 

### Ms. DebbieEdwards,ActingDirector, Registration Division 

### Ms. DeborahMcCall, InsecticideBranch, RegistrationDivision 

### Mr. George

### LaRocca, ProductManager, InsecticideBranch MichelleKnorr,Esq., Pesticides and ToxicSubstances 

### LawOffice 

### Jeffrey S. Pritchard, United

### Phosphorus Inc.



# 222

# ..
,

# ..



# •

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



### United Phosphorus, Inc. c/o

### Ms. Elizabeth A. Brown,

### Ph.D. ChemReg 

### International, LLC .n, 

### 19900IdBridgeRoad,»201**.~Ridge,** 

### VA 221.!
..... Dear

### Ms. Brown: 

# JJl32002

SUBJECT: AppUcation for**~** 

### , 

### Bifenthrin TechnicallnsecticidelMiticide EPA File Symhol: 10S06-RI 

### YourResubmission Dated Msy 

### 8, 2002 OFFICE OF PREVENTION. peSTICIDES AND TOXIC SUBSTANCes



### EPA hss 

### reconsideted itspositionwith respectto

### the 

### subjectapplication nnd 

### determined**thattheapplicationlsincompletetOrlliC-'gI~IliC~'sAPri12S.20021etter: ,~>l"**  . 

# '*"/
. . "An 

### appUcstion is consideted incomplete ifany pertinent

### item specified 

### in §

### 152.50 hss 

### not been

### submitted. Pursuant to 

### §152.50(f) an appUcantmust submit msterials to 

### demonstrate thathehss

### compliedwith FlFRA sec. 3(cXI)(D) nnd subpart

### E ofpart 152**~lUCS**

### to 

### IlnsUIc

### Protection ofOata S.ubmitters'Rights). Therefore, you must submit a completed Certification with 

### Respect to 

### Citation ofData 

### (EPA Form 857()"34) indicating the Method ofData Supportyou are using. 

### You must 

### also submit a Ust of companies sent

### offers ofcompensation for data

### you are citiog in

### supportofthls appUcation." We reached ourdecision after

### consnItation with attorneys 

### inthe Office ofGeneral 

### Council nnd 

### the Registration Division's senior managementteam. 

### Itwas agreed

### thet appUcstioas which do 

### not comply with the data compensation regulations at

### the time of submission will be considered incomplete nnd 

### that we will 

### not spend resources reviewing such appUcstions until materials

### to 

### completethe appUcstion have 

### been submitted. We recognize that 

### you may have been

### allowed in the pastto 

### submitthese msterials later in

### the review process. 

### However, 

### we do not beUeve 

### that

### this practice is supported by the regulatioas. The 

### regulation which 

### you cite as allowing 

### submission at • 

### laterpoint (40 CFR §152.M) hss

### been interpreted to 

### mean 

### thatthe Agency would not**~ect** 

### an applicstion outright 

### ifitis missing information on the data

### compensation forms. The 

### regu\ation does 

### not envision

### that an applicant

### be required to 

### comply with subpartE 

## lIllIx after

### the application hss

### been determined to 

### be acceptable for registration. Such a determination cannotbe made until the data compensation requirements have been

### met.


# 223

# •

• -2- Your May 8, 2002 letter asked us to confinn that the subject application bas 

### been detennined to be acceptable. It bas 

### not. We beve not begun to review the data, data matrix, CSF 

### or draft 

### label which you submitted in 

### support ofregistnUion and will not begin review

### ofthase 

### materials wrtil you submitthe 

### infonnation requested above. If

### you have any 

### questions regarding 

### this action, 

### please contact Susan StanIOn ofmy team 

### at 

### (703) 

### 305-5218.**~T.LaRocca** 

### PrOductMaMger (13) 

### Insecticide Branch 

### RegistnUion Division (7505C)



# 224

## •



# •

• 1990 OLD BRIDGE ROAD, SUITE 201 LAKE RIDGE, VIRGINIA 22192-2383 DIREcr: 703-492-7905 MAIN: 703-492-0445 Fax: 703-492-0668 E-MAIL: brown@chemreg.com WnBSITESt www.chemreg.com www.pesticide.net 

### ELIZABEl'HA. BROWN, PH.D. 

### May 8, 2002 

### Document Processing Desk U.S. Environmental Protection Agency (7505C) U.S. Environmental Protection Agency 

### Room 266A, Crystal Mall 2 1921 Jefferson Davis Highway Arlington, VA 22202-4501 At1n: George LaRocca (PM 13) 

### •••• 

### • 

# . ., •



# . '. 

### • • • • • • Re: Application for Registration ofBifentrhin Technical InsecticideIMiticide, United Phosphorus, Inc. EPA File Symbol 70506-RI Agency Letter ofApril 25, 2002 

### Dear George: 

## • •• • •



# .. .

•

• •

• 

## • 

# ...

• •

### •••



# ... 

# .. . • 

## • • 

### •

In your letter ofApril 25, 2002 (copy enclosed), you stated that the Agency will not 

### continue processing the application for registration ofthe 

### above product ifEPA 

### Form**8570~34** 

### and associated materials were not submitted within 75 days ofthe date ofreceipt ofyour 

### letter. As 

### clearly stated in the submission materia1s accompanying the application and as expressly permitted under 40 CFR 152.84 and EPA's Federal Registernotice regarding that regulation (40 Fed. Reg. 30884, Aug I, 

### 1984), United Phosphorus is allowed to and will 

### submit a completed Certification 

### with Respect to Citation ofData form to your office. and send the necessary data compensation offers to companies listed on the enclosed data matrix. once we obtain confinnation from your 

### office that the enclosed data matrix is acceptable and that EPA has decided to 

### approve the enclosed application. (See enclosed copy of April II, 

### 2002 letter). 

### Your letter ofApril 25, 2002, is unclear as to whether the Agency has reached a decision on approval ofthe application for registration. Please confirm in writing that your letter ofApril 25. 2002, was confinnation that the 

### April 11.2002 application has been determined to be 

### acceptable and that the Agency has decided to approve the application for registration. Once we receive that confirmation, the appropriate materials will be submitted to the Agency. Until that conftrmation is received, however, the applicant is not required to submit the materials requested 

### in your letter and the Agency may not delay review ofthe application.
CONSULTANTS TO SUCCESS"'i Over One Hundred andFiftyYears ofCombinedExperienceAssisting Chemical, Pesticide,**Bio~Chemical** andLifeScienceCompanies on a WideRangeofIssues, Jrt.cluding Regulatory Strategies,Registration, Data Support and Compensation, QualityAssurance, Study**D~~** andScientificMatters. L..j .,

## • •• • • 

# ·

# ..

• •

• • 0 

# ... • ••••

### • 

# ... 

# ...

- " 

## • • • ••• 

### • 

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# ..**~~** 

## • • ••• • 

## • • • •



## • • 

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# •



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•



# 232

# ,



# •

• George LaRocca 

### May 8, 2002, page 

### 2
Ilook forward to your response. Please do not hesitate to contact me if

### you have any 

### questions. Regards,

# ~~~.-..J E1izabetll Anne Brown 

### Enclosures: 1. EPA letter ofApril 25, 

### 2002 (George LaRocca) 

### 2. ChernRegInternational, LLC letter ofApril II, 

### 2002, on behalfofUnited Phosphorus

cc: United Phosphorus, Inc. James**Wrigh~** Esq., Wright & SiOIaty P.C
.



# 233

# •

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


## APR 25 2002 OFFICE OF PREVENTION, PESTICIDES ANaTOXIC SUBSTANCES 

### United Phosphorus, Inc. 

### elo 

### Ms. Elizabeth A. 

### Brown, Ph.D. ChemReg International, LLC 1990 Old Bridge Rond, Suite 20I Lake Ridge, VA 22192·2383**~v.** 

### ,**"~~**

# .................................. Dear Ms. Brown: 

### SUBJECT: Application for Registration Bifenthrin TechnicallnsecticidelMiticide 

### EPA File Symbol: 70506·R1 Your Submission Dated April 1\,2002 The application referred to 

### above bas been determined pursuant to 40 CFR §

### 152.104, not to be 

### sufficiently complete to 

### process; therefore, the application is considered deficient. 

### Labeling, data andlor other information as specified below must be submitted before the processing ofthe 

### application can 

### be completed. Ifsuch deficiencies cannot be 

### corrected 

### within 75 days, you must notify the Agency within those 75 days ofthe 

### date you expect to complete the application. 

### If. after 

### 75 days you do Dot 

### respond. or you subsequently 

### fail to complete the application within tile time 

### scheduled for 

### completion, the agency will terminate any action on the application, and will treat the application as if

### it has been withdrawn by the applicant. 

### Any subsequent submission relating to 

### the application must be submitted as anew application. 1. 

### An 

### application is considered incomplete if

### any pertinent item specified in §

### 152.50 has not 

### been submitted. Pursuant to 

### §

### 152.50(1) an applicant must submit materials tt} demonstrate lI"the has complied with FIFRA see. 3(c)(I)(D) and subpart E ofpart 152 (Procedures to Ensure Protection ofData 

### Submittersl 

### Rights), Therefore, you must 

### submit a completed Certification with Respect to Citation ofData (EPA Form 8570.34) indieating the Method ofData Support you are using. You must also submit a list 

### of companies sent offers ofcompensation for data you are citing in support 

### ofthis application.



# 234

# •

• -2- 

### lfyou have any questions regarding this action, please contact Susan Stanton ofmy 

### team at 

### (703) 305-5218. 

### Sincerely yours,

# jf:;:;:i~f- Product Manager (13) 

### Insecticide Branch 

### Registration Division (7505C)



# 235

# •

•**----~~-~--~~-------**

1990 OLD BRTDGE ROAD, SUTTE 201 LAKE RIDGE, VIRGTNIA 22192-2383 Dnmcr: 703-492-7905 MAIN: 703-492-0445 Fax: 703-492-0668 E-MAIL: brown@cltemreg.com WEB SITFS: www.chemreg.com www.pcsticlde.net ELIZABEl'H

### A. BROWN, PH.D. 

### April 8, 2002 Document Processing Desk (APPL) U.S. Environmental Protection Agency (7505C) U.S. Environmental Protection Agency Room 266A, Crystal Mall 2 1921 Jefferson Davis Highway Arlington, VA 22202-4501 Attn: George LaRocca (PM 13) 

# .... ,

# ... ; 

## • 

# - • • • • 

# ....... • 

## • • •



# _. ......

• • • • 

# ....... .,w, 

### • 

# ..... • • 

## • 

# ..... , • 

### • 

## • •

### ••••• 

### • •

•

### •••

w ••• 

### •• 

## • • •**~** 

### • 

# .. Re: Application for Registration of "Me-Too" Bifentrhin Technical insecticidelMiticide On behnifofour client, United Phosphorus, Inc. (UPI), we are submitting an application for a "me-too" registration ofBifenthrin Technical InsecticideIMiticide (EPA Product Code 

### 128825). This product is substantially sintilar to the already registered EPA Reg No. 279-3055. Enclosed please find: Transmittal bibliography Three (3) copies ofeach submitted study Application form 8570-1 Five (5) copies ofthe proposed label Data matrix forms for EPA and public use (Form 8570-35) Please note that we are re1ying upon the selective cite-all method to satisfy data requirements that have not been satisfied by data submitted by 

### UPI As expressly permitted under 40 CFR § 

### 152.84 and various Federal Register notices, UPI will submit compensation offers to companies listed on EPA's Data Subminers Ust as ofthis date after you have determined that the application is acceptable and ready for approva1. As Slated by 

### EPA in the Federal Register: Before the Agency 

### will approve this applicant, the applicant must certify that he bas 

### obtained the authorization of, or made appropriate offers to pay to, each person on the Data 

### Submitters list
... As 

### in the past, the applicant

# will be permitted to submit his
CONSULTANTS TO SUCCESS'" Over OneHundred andFiftyYears ofCombinedExperienceAssistingChemical, Pesticide, BiowChemical andLife ScienceCompaniesona WideRange 

### ofIssues, IncludingReg(i)A4itY Strategies, Registration, Data Support and Compensation, 

### QualityAssurance, Study"Dfr'mjfn

# •

• Letter to G. LaRocca. April 8. 2002. page 2 

### certification and general offer to 

### pay

### atany time before registration is 

### approved. 

### The Agency will 

### not delay the review ofthe application pending receipt ofthese statements. but will notapprove the application until they are received and determined to bein 

### compliance. 49 Fed. Reg. 30884 (Aug. 1. 1984). 

### FinalRule: Pesticide Programs: Pesticide Registration **and** 

### Classification Procedures,'Application Procedures To Ensure Protection of Data 

### Submitters'Rights. As 

### sllch, we will 

### submit acompleted Certification 

### with Respect to Citation ofData form to 

### your office, and send the necessary data compensation offers to companies listed 

### on the enclosed data matrix. ODce 

### we obtain confirmation from your office 

### that the enclosed datamatrix is accepmble and that EPA

### has decided to approve the enclosed application
. UPI's technical grede bifenthrin is ofa higher purity that thnt ofthe substantially similar EPA Reg. No. 279-3055. However. the enclosed studies identify that the acute oral and dennal 

### toxicity are comparable to that ofthe**~gistered** 

### product Since itis 

### known and well-documented for pyrethroids 

### that the isomerratio is ofgreater importance than 

### slight differences in 

### purity and since 

## uprs product has acomparable isomeric ratio to that ofthe registered product and does not contain impurities oftoxicological concern. 

# the UP!

### product should be considered as comparable to the already registered product 

### With respect to

### physical/chemical characteristics. the data generated using 

### the Pure Active Ingredient and already on file 

### atthe Ageney is applicable regardless ofthepurity ofthe technical grede material. These dam are OPPTS 830.7050 (UVNisible Absorption). OPPTS 830.7220 (MeltingPoint). OPPTS 830.7950 (Vapor pressure). OPPTS 830.7370 (Dissociation Constant). OPPTS 830.7550 (OctanoVwaterpartition coefficient). Other characteristics. suchas solubility. 

### are not appreciably affected by the minor differences in 

### the purity ofthe technical material, which is insoluble in water. Inasmuchas the material is solid. OPPTS 830.7220 (boiling pnint) is not applicable. Based on both 40 CPR 158.190(a) and OPPTS 830.1000. we believe that the following 

### data 

### requirements are not pertinent for the registration ofBifenthrin Technical InsecticideJMiticide: 1. one year storage smbility study (OPPTS 830.6317) 2. corrosion characteristics (OPPTS 830.6320) 3. mddationlreduction (OPPTS 830.6314) 4. viscosity (OPPTS 830.7100) 5. flammability (OPPTS 830.6315) 6. explodability (OPPTS 830.6316) 7. miscibility (OPPTS 830.6319) 8. dielectric breakdown volmge (OPPTS 830.6321)


# 237

# . . 

# .



# •

• Letter to 

### G. LaRocca, 

### AprilS, 2002, page 3


### UP! is 

### requesting awaiver from the requirements to assess the stabilityto 

### metal and metal ions 

### under OPPTS 830.6313, 

### as the product is 

### packaged, stored, and shipped in

### high density 

### polyethylene and 

### is not in 

### contact with metals ormetalions. The submitted study meets the requirements for stability to 

### normal and elevated temperntnres under OPPTS 830.6313. 

### We trust that, 

### with 

### the enclosed documents; the Agency can expeditiously issue 

## uprs registration. Should you have any questions regarding the enclosed material, please do nothesitate to call. 

### Sincerely,

# ~;U-""U~~~ Elizabeth Anne Brown, Ph.D.
cc: UP!



# 238

# •

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


## APR 25 2002 OFFICE OF PREVENTION. PESTICIOES ANO TOXIC SUBSTANCES 

### United Phosphorus. Inc. clo Ms. Elizabeth A. Brown, Ph.D. ChemReg International, LLC 1990 Old Bridge Road, Suite 201 Lake Ridge, VA 22192·2383 Dear Ms. Brown: 

### SUBJECT: Application for Reglstration Bifenthrin Technica11nsecticideIMiticide 

### EPA File Symbol: 70506·R1 Your Submission Dated April 11, 2002 The application referred to above bas been 

### detennined pursuant to 40 CFR §

### 152.104, not to be sufficiently complete to process; therefore, the application is 

### considered deficient Labeling, data andlor otherinformation as specified below must be submitted before the processing ofthe application can 

### be completed. [f

### such deficiencies cannot be 

### corrected 

### within 75 days, you must notifY the Agency within those 75 days ofthe date you expect to complete the application. If,

### after 75 days you do not reapond, otyou subsequently fail to

### complete the application within the tbne scheduled for completion, the agency will tenninate any action on the 

### application, and will treat

### the application as ifithas been withdrawn by the applicant. Any subsequent submission relnting to the application must be 

### submitted as anew application. 1. 

### An application is considered incomplete if

### any pertinentitem specified in §

### 152.50 bas not been

### submitted. Pursuant to §

### 152.50(1) an applicant must submit materials to demonstrate that he bas complied with FIFRA sec. 3(cXl)(D) and subpartE ofpatt 152 (Procedures to Ensure Protection ofData Submitters' Rights). Therefore, you must submit a completed Certification with Reapect to 

### Citation ofData (EPA Form 8570-34) indicating the Method ofData Supportyou are using. You must also submit a list of companies sent offers ofcompensation for data you are citing 

### in support ofthis application.



# 239

## •



# •

• -2- 

### Ifyou have any questions regarding this action. please contact Susan Stanton ofmy team at 

### (703) 305-5218. Sincerely yours,

# /~/~L George T. LaRocca 

# 7

- Product Manager (I3) 

### Insecticide Branch Registration Division (7S0SC)



# 240**-----------~--------------------**



# •

• U.S. ENVIRONMENTAL PROTECTION AGENCY Office of Pesticide Programs 

# APR 192002

UNITED PHOSPHOROUS, INC. 1209 ORANGE STREET WILMINGTON, DE 19801 Report of Analysis for Compliance with PR Notice**86~5** 

### Thank you for your transmittal of 04/11/02. 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 lO's (MRIDs) assigned to each document submitted. Please use these numbers in all future references to these documents. Thank you for your cooperation. If 

### you have ariy 

### questions concerning this data submission, please raise them with the cognizant Product Manager, to whom the data have been released.



# 241

..

### _--------

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



### UNITED PHOSPHORUS, INC. 423 RIVERVlEWPLAZA TRENTON, NJ 086II 411512002

PRODUCT NAME: BIFENTHRIN TECHNICAL INSECTICIDEIMITICIDE COMPANY NAME: UNITED PHOSPHORUS, INC. OPP IDENTIFICATION NUMBER: 294229 EPA FILE SYMBOL: 70506-RI EPA RECEIPT DATE: 4/1 1102 

### SUBJECT: RECEIPT OF APPLICATION FOR ANEW REGISTRATION DEAR REGISTRANT: OFfiCEOF PREVENTION. PESTICIO€SANO TOXIC SUBSTANCES



### The Office ofPesticides 

### Programs has received your application for a new registration 

### and 

### it has passed an administrative screen for completeness. Please note 

### that this is only a notification ofreceipt of your application. This is only the first step in the application process. and does NOT constitute approval. 

### If

### you have any questions, please contact the Insecticide Branch at 703-305-7448. Sincerely•

# ~**~-J;u"",--** Front End Processing Staff Information Services Branch Information Resources &. 

### Services Division

Intornoi Address (URLJ • htlpJfWMV.opa,go'l RtteyclodlRoeyclDbkl_Prlnllld with Vegolablo all Baud 'nkl. on Roeyc:lod Pllpor (Minimum 50% PoslCon'lIrMreontontl 

# 242

# •

• TRANSMITfAL DOCUMENT

United Phosphorus, Inc.

740 Springdale Drive Suile 204 Ex!on, PA 

### 19341 

### SubmjUer Uniled Phosphorus, IncChemReg International, LLC* 

### 2239-H Tacke!1S Mill Drive Lake 

### Ridge, VA 22192-3026 *ChemReg Internalional is the authorized represenJative for United Phosphorus, Inc. 

### Reau1atop' action in supPOrt 

### ofwhich this packalZe 

### is submit!ed New Product Registralion**~"Me-** 

### Too") (Bifenthrin Technical InsecticideIMilicide 10506-x)

SpbmlttedStudl"" 

### MRID



## - Administrative Materia1s Document 1: 

## 45654401 Brown, E.A. March 19.2002. Bifenthrin Technica1 Insecticide. Producl Identity, Composition, and Analysis (Group A). Compilation Report No. UPI-Bifenlcch-A. 219 pgs. 

### Contaills ConfidentialBusiness **Il1fonllation.** 

### Document 2: 

## 45654402 Joshi, C. 

### Nov 12.2001. Appearance (colour. physical Slate, 

### and odor) ofbifenlbrin_ JRF srudv number 3591_ 13 pg. Document 3: 

## 45654403 Palel. A.H. Sept 5, 2001. Accelerated storage stability of bifenthrin. JRF swdy number 3220. 81 pg. Documem4: 

## 45654404 Tiwari. V.K. Feb. 9, 2002. Acute oralloxicily study of bifenthrin lechnical in rats. Jai 

### Research Foundation. JRF 

### Study No. 3415. 33 pages. Document 5: 

## 45654405 Tiwari. V.K. Feb 9, 2002. Acute dermal toxicilY study of bifenlhrin technical in mts. Jai Research Foundation. JRF 

### Srudy No. 3416. 27 D.oes. Company Official Company Name: Company Contact: ChemReg International. LLC.. Authorized Representalive for UPI Elizabeth Anne Brown Phone Number. 

### 703-492-7905


# 243

# ..



# •

• '- 

## 456544-00 1990 OLD BRIDGE ROAD, SUITE 201 LAKE RIDGE, VIRGINIA 22192"2383 DIRECl': 703-492-7905 MAIN: 703-492-0445 Fax: 703-492-0668 

### ELIZABETH

### A. BROWN, PH.D. April 8. 2002 DocumentProcessing Desk (APPL) U.S. Environmental Protection Agency (7505C) U.S. Environmental Protection Agency Room 

### 26M. Cxystal Mall 2 1921 Jefferson Davis Highway Arlington. VA 22202-4501 Attn: George LaRocca (PM 13) E-MAn.: brown@chemrcg.com WEBSrrns: www.c:hemreg.com www.pesticide.net



### Re: Application for Registration of"Me-Too" Bifentrhin TechnicallnsecticideIMiticide On behalfofour**clien~** 

### United Phosphorus. Inc. (UP!), we are submitting an application for a "me-too" registration ofBifenthrin Technicalli1secticidelMiticide (EPA Product Code 128825). This product is substnntialiY similar to the 

### already registered EPA Reg No. 279-3055. Enclosed please find: Transmittal bibliography Three (3) copies ofeach submined study Application form 8570-1 Five (5) copies ofthe proposed label Data matrix forms for EPA and public use (Form 8570-35) Please note that we are relying upon the selective cite-ali method to satisfy 

### data requirements that have not been satisfied by 

### data submined by UPI. As 

### expressly permitted under 40 CFR § 

### 152.84 and various Federal Register notices, UPI will submit compensation offers to companies Jisted on EPA's Data Submitters list as ofthis date 

### after you have determined that the application is acceptable and ready for approval. As stated by EPA in the Federal Register: Before the Agency will approve this**applican~** 

### the applicant must certify that he has obtained the aUlhorization of, or made appropriate offers to 

### pay to, 

### each person on the Data Submitters List.
... As in 

### the past, the applicant will be pennitted to submit 

### his
CONSULTANTS TOSUCCES$''' Over OneHundred andFiftyYears 

### ofCombined Experience

### Assisting Chemical,Pesticide, Bio-Chemical andLife Science Companiesona Wide Range 

### ofIssues, IncludingRegulatory Strategies, Registration, Data Support and Compensation, QualityAssurance, Study**~** and ScientificMatters.

# •

• Letter to G. LaRocca. April 8.2002. page 2 certification and general offer to 

### pay 

### atany time before registration 

### is approved. 

### The Agency 

### will not delay the review ofthe application pending receipt ofthese statements. but will 

### not,approve the application until they are received and detennined to be in 

### compliance. 49 Fed. Reg. 30884 (Aug. 1. 1984). 

### Final Rule: Pesticide Programs; Pesticide Registration **and**

### Classification Procedures; Application Procedures To Ensure **Protl!CtiOIl** 

### of Data Subminers'Rights. 

### As such, we will submit a completed Certification with Respect to Citation ofData form to your office, and send the necessary data compensation offers to companies listed on the enclosed data matrix, once we 

### obtain confirmation from your office that the enclosed data matrix is 

### acceptable and that EPA has decided to approve the enclosed application
. UP]'s technical grade bifenthtin is ofa higher purity that that ofthe substantially simliar EPA Reg. No. 279·3055. However. the enclosed studies identify that the acute oral and dermal toxicity are comparable to that ofthe registered product' Since it is known and**wen~documented** 

### for pyrethroids 

### that the isomerratio is ofgreater importance than slight differences in purity and since 

# uprs product 

### bas acomparable isomeric 

### rariq to that ofthe registered product and does not contain impurities oftoxicological concern, the UPI product should be considered 

### as comparable to 

### dIe already registered product With respect to physical/chemical characteristics, the data generated using the Pure 

### Active 

### Ingredient and already on file at the Agency is applicable regardless ofthe purity ofthe technical grade material. These data are OPPTS 830.7050 (UVNisible Absorption). OPPTS 830.7220 (Melting Point), OPPTS 830.7950 (Vapor pressure). OPPTS 830.7370 (Dissociation Constant). OPPTS 830.7550 (Octanolfwaterpartition coefficient). Other characteristics. such as solubility• are not appreciably affected by the minor differences in the purity ofthe technical material. which 

### is insoluble in water. Inasmuchas the material is solid. OPPTS 830.7220 (boiling point) is not applicable. Based on both 40 CPR 158.190(0) and OPPTS 830.1000. we believe that the following data requirements are not pertinent 

### for the registration ofBifenthrin Technical lnsecticideIMiticide: 

### 1. one year storage stability study (OPPTS 830.6317) 2. corrosion characteristics (OPPTS 830.6320) 3. oxidation/reduction (OPPTS 830.6314) 4. viscosity (OPPTS 830.7100) 5. flammability (OPPTS 830.6315) 6. explodability (OPPTS 830.6316) 7. miSCibility (OPPTS 830.6319) 8. dielectric breakdown voltage (OPPTS 830.6321) 

# 245 .•**-------~-------~-**- 

### ----._--



# •

• Letter to G. LaRocca, April 8. 2002. page 3
UPI is requesting awaiver from the requirements to assess the stability to metal and metal 

### ions under OPPTS 830.6313. 

### as the productis packaged. stored. and shipped in high density polyethylene and is not in 

### contact with metals or metal ions. The submitted study meets the 

### requirements for stability to normal and elevated temperatures under OPPTS 830.6313. 

### We trust**tha~** 

### with the enclosed documents. the Agency can expeditiously issue UP!'s registration. Should you have any questions regarding the enclosed material, please do not hesitate 

### to call. 

### Sincerely•

Elizabeth Anne Brown. Ph.D.
cc: UP!



# 246

# •
• 1990 OLD BRIDGE ROAD, SUITE 201 LAKE RlDGE, VlRGlNIA**22192.~2383** DIRECT:**703~492."'905** MAIN:**703·492~044S** Paxl**703~492~o668** 

### ELIZABETHA. 

### BROWN, PH.D. April 8, 2002 Document Processing Desk (APPL) U.S. Environmental Protection Agency (7505C) U.S. Environmental Protection Agency Room 266A. 

### Crystal Mall 2 

### 1921 Jefferson Davis Highway Arlington. VA 222024501 Attn: 

### George LaRocca (PM 13) ErMAn.: brown@chemreg.com WBBStTF.S: www.cbemreg.com www.pes:ticide.net



### Re: Application for Registration of"Me-Tod' Bifentrhin Technical Insecticlde/Miticide On behalfofour client, United Phosphorus, Inc. (UPI). we are submitting an application for a**"me~too"** 

### registration 

### ofBifenthrin Technical InsecticldeIMiticide (EPA Product Code 

### 128825). This product is substantially similar to the already registered EPA Reg No. 279-3055. Enclosed plesse find: Transmittal bibliography Three (3) 

### copies ofeach submitted study Application form 8570-1 Five (5) 

### copies ofthe proposed label Data matrix forms for EPA and public use (Form 8570-35) Please note 

### that we are relying upon the selective cite-all method to satisfy data requirements that have not been satisfied by 

### data 

### submitted by 

### UP!. 

### As expressly permilled under40 CFR § 

### 152.84 and various FedernI Register notices. UPI will submit compensation offers to 

### companies listed on EPA's Dam Submitters Ust as ofthis date after you have detennined that the application is acceptable and ready for approval. As stated by 

### EPA in the FedernI Register: Before the Agency will approve this applicant, the applicant must certify that he has obtained the authorization of. or made appropriate offers to pay to, each person on the Darn Submitters List.
...As in the past, the applicant will be 

### pennined 

### to submit his
CONSULTANTS TO SUCCESS''' Over OneHundred andFiftyYearsofCombinedExperienceAssisting Chemical, Pesticide, Bfo-Chemical and LifeScience Companies on a Wide: Range ofIssues, IncludingRegulatory Strategies. Registration, Data Support and Compensation, QualityAssurance, StudyDesign andScientific

### Matters. 

# 247

## .I



# •

I i 

# • Lener to G.l.aRocca, April 8, 2002, page 2 certification and general offer to pay 

### atany time before registration is approved. The 

### Agency will 

### not delay the review ofthe application pending receipt ofthese statements, but will 

### not approve the appIication until they are received and detemlined to be 

### in compliance. 49 Fed. Reg. 30884 (Aug. I, 1984), 

### FinalRule: Peslit·ide Programs; Peslicide Registrah"on and Classification Procedures; Applicah'oll Procedures To-

### Ensnre Pmteclion 

### of Data Submitters' **RI'glllS.** 

### As suchl we wiU 

### submit a completed Certification with Respect to 

### Citation ofData form to your office. and send the necessary data compensation offers to companies listed on the enclosed data matrix, once we obtain confirmation from your office 

### that the enclosed data matrix is 

### acceptable and that EPA has decided to approve the encIosed application. UPl's technical grade bifenthrin is ofa higher purity that that ofthe substantially similar EPA Reg. No. 279-3055. However, the enclosed studies identify that the acute oral and dennaJ toxicity are comparable to 

### that ofthe 

### registered 

### product Since it 

### is known and well-documented for pyrethroids that the 

### isomerratio is ofgreater imponance than slight differences in purity and 

### since UPl's product has a comparable isomeric ratio to 

### that ofthe registered product and does not contain impurities oftoxicological 

### concern, the 

### UPl 

### product should be 

### considered as comparable to the already registered procluct. 

### With respect to 

### physical/chemical characteristics. the data generated using the Pure Active Ingredient and already on file at 

### the Agency is applicable regardless ofthe purity ofthe technical grade material. 

### TIle.,e data are OPPTS 830.7050 (UVNislble Absorption), OPPTS 830.7220 (Melting Point), OPPTS 830.7950 (Vapor pressure), OPPTS 830.7370 (Dissociation Constant). OPPTS 830.7550 (OctanoVwater partition coefficient). Other characteristics, such as solubility. are not appreciably affected by the minor differences in the purity ofthe technical material, which 

### is insoluble in water. Inasmuchas the materia] is solid, OPPTS 830.7220 (boiling point) is not applicable. Based on both 40 CFR 158.190(0) and OPPTS 830.1000, we believe that the following 

### data requirements are not peninent for the registration ofBifenthrin Technical Insecticide!Miticide: I. one 

### year stol3ge stability study (OPPTS 830.6317) 2. corrosion characteristics (OPPTS 830.6320) 3. oxidation/reduction (OPPTS 830.6314) 4. Viscosity (OPPTS 830.7100) 5. flammability (OPPTS 830.6315) 6. explodability (OPPTS 830.6316) 7. miscibility (OPPTS 830.6319) 8. dielectric breakdown voltage (OPPTS 830.6321)


# 248**-~------~------,---,-~~~--------------------** 

### -.I



# •

• loner to 

### G. LaRocca, April 8, 2002, page 3


### UPI is requesting awaiver from the requirements to assess the stability to metal and metal ions under 

### OPPTS 830.6313, as the product is packaged, stored, and shipped in high density 

### polyethylene and is not in contact with 

### metals or metal ions. The submitted study meets the requirements for stability to nonnal and elevated temperatures under OPPTS 830.6313. We trust that, with the enclosed documents,**t~e** 

### Agency can expeditiously issue 

## uprs registration. Should you have any questions regarding the enclosed material, plea..'\e do not hesilale to call. 

### Sincerely,

Elizabeth Anne Brown, Ph.D.

cc: UPl



# 249

# •

• TRANSMITTALDOCUMENT

United Phosphorus, Inc.

740 Springdale Drive Suite 204 Exton. PA 19341 

### Submitter United Phosphorus, Inc

### ChernReg International. LLC'" 2239-H Tacketts Mill Drive Lake Ridge. VA 22192-3026 *ChemReg International is the authorized representative for United Phosphorus,lnc. 

### Regulatory action in 

### supPOrt of

### which this package 

## is submitied**~** 

### New Product Registration ("Me-Too") (Bifenthrin Technical Insecticide/Miticide 70506-x) 

### Tmnsmitlal Date

April II. 2002 

### SubmltWd Stu41
.. MRID



# - 

# - Document 1:

-Document 2: Document 3: Document 4:

Document 5:
Company QfficiaJ Company Name: Company Contact: Phone Number: 

### Administrative Materia1s Brown. B.A. March 19.2002. Bifenthrin Technical Insecticide. Product Identity, Composition, and Analysis (Group A). Compilation Report No. UPI-Bifentech-A. 219 D!!S. 

### Contains.ConMemiolBusiness lnfonnarion. Joshi. C. Nov 12, 2001. Appearance (colour, physical state, and odor) ofbifenthrin. JRF study number 359 I. 130•. Patel. A.H. Sept S. 20(H. Accelerated stomge stability of bifenthrin. lRF study number 3220. 81 

## DI!. Tiwari. V.K. Feb. 9. 2002. Acute oral toxicity study of bifenthrin technical in 

### rats. lai Research Foundation. JRF StudY No. 3415. 33 o.oes. Tiwari. V.K. Feb 9. 2002. Acute dermal [oxicity study of bifenthrin technical in 

### rats. lai Research Foundation. lRF Study No. 3416. 270uees.

ChemReg International. LLC.• Authorized Representative for UPI Elizabeth Anne Brown 703492-7905


# 250UnIted State. 

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# o Rosubmlss!on In response 10 Agency !etler da!od ___ _ NoHficatiofl- Exp!a!n be/ow



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# J,~ Form, dOMSI

burden estimate or any other aspect ofthis collection ofinformation. including suggestions forreducing: lbe burden to: Director. OPPElnfonnation Management Division (2137). U,S. Environmental Pro!:ection nc .401 MStreet, S.W.. Washi on DC 20460. Do not send lbe form to this address. DATAMATRlX 

### 102 1.20 102 

# IEPA Reg No.1 File Symbol 

# IPage I of3
__ . ____gNo.1 Ale 1 

# TpageTon**·~···­** United I....... 423 Riverview Plaza Trenton, NJ 08611 Ingredient: Bifenthrin (PC 128825)

51·1 (830.1550) 61·20(830.1620) 

### ,,j 61-2b (830.1670) 

# V\ 62·1 (830.1700)

, , ......v .. JU", g (830.7840)**~** (830.7950) 10 (830.7370) II (830.7550) 

### eStudy Name "Cl"

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## -- 

## ranalysis 10 oflimits Anal tical method Color Ph si, Odor 

### uvr

12 (830.7000) 

## I oH**~** process**~.~** 

# .-

# .. - [MRIDI



# ICITE ALL

CITE. CITE AI

:rrEAL 70506-

sine I UPI

UPI FMC Corp A_ (FMC); The Seous Co (SeOIIS); The Andersons uwn Fertilizer Dhision, Inc. (Andersons) FMC, Scotts, Andersons FMC, Scons• . FMC, Scotts. FMC, Scons,

-13 (830.6313) Stabililv ••: ••_ .:. -:- : UI 71-lb(8SO.2100) Aviunncuteorai40xicM •• _ _ • __ : CITE All FA 71-2 (850,2200) Avian diet toxitit. •• •• CITE ALL FA**~** ScotLo;. Status Own Own 

## lWi1**)~n** lwn 

# own Own 

### Owil Owil pay 

### IPay


### I Pay 

# i l'a own own p, Note

Signalure

### ~....<bVt:t.v...

### ~ Name and Title 

# IDate Elizabeth Anne Brown, ChemReg International. LLC 4/1112002 Registrution Agent 

### EPA Fonu**8570~3.st9~97)** 

### ElecrrOoiCiind Paper versions available. Submit only I".tper version, Agency Inlernal Use Copyhours per response for reregistration and special burden estimate or any other aspect of this colleclion

Phosphorus. Inc. 423 Riverview Plaza 1

Signature 

## i"h.,." •..,d;...u..

### ~ A'NlTEDSTATES ENVIRONMENTAL
.- 401 J'ECTION AGENCY
10 average and completing the necessary fonns. Send commeots reganling the to: Director. OPPEInfonnation Management Division (2137),

'1*. 

### t?,.-/(" r" '" I '/., 

# I '",VO- St/b,.,....J**.f/~ iA..J.,..,J~** **~** j Product: Bifenlhrin Technical InsecticidelMiticide 

### cz.vtd k...-t4**~U~J** . 

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# I,ei J)/';' 

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## 'u_ 

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Name and Title Elizabelh Anne Brown, CbemRcg Intem.1Iional. LLC Registration Agent Dale 411112002 EPA Fom18570-35 (9-97) 

### EJectronicruid Paper \'cr.;ions available. Submit only Paperversion. Agency Internal Use Copy

## ~"'~l .NlTEDsTATFS

### ENVIRONMENTAL~Cl10N AGENCY Fonn Approved OMB No. 2070-0060



# -**-~** 401 MS
......S.W. WASHINGTON. D.C. 20460 Paperwork Reduction Act Notice: The public reporting burden for this collection ofinformation is estimated to a... erage 0.25 boun; perresponse forregistration activities and 0.25 hours perresponse for reregistration and special review activities, including lime for reading the instruction and completing the necessary fonns. Send comments regarding the burden estimate or any otheraspect ofthis collection ofinformation. including suggcstiOfl'> forreducing the burden to: Director, OPPE Information ManagementDivision (2137), U.S. Environmental Protection**A~IlCY.** 40 I M Street. S,W.• Washington DC 20460. Do not send the form to this address.
Date: March 20, 20002 Applicant'sJRegistrant's Name and Address: United Phosphorus. inc. 423 Riverview Plaza Trenton. NJ 08611 Ingredient: Bifenthrin (PC 128825) Guideline Reference Number Guideline Study Name 83-3b (870.3700)**Temto~nicit** - rabbit 84-2 Muta nidI studies 85-1 (870.7485) General metabolism 85-2 Dermal absorption 161-1 

### Hydrolysis 161-2 Photodegradation in water 162-1 Aerobic soil metabolism 163-1 Adso tionldeso 'on 164-1 (875.2200) Reid soil dissi tion 1654 Bioaccumulation in fish S cia] studies Other 132-1 (857.2100) Rlliar residue dissipation 133-3 (875.2400. 2500) Dennal exposure
1334(857.2500) Inhulation exposure
201-1.202-1 (840.1100. Spmy drift and droplet size 835.4200) 

### ••• • • 

## • • • • • N 

### • 

## • • • • • • <Jl 

## • • 00 Signature

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### ••• 

## • • 

## • • ••• 

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### ••• •• 

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### • • • 

## • • • • • 

## •• •• • 

## • DATAMATRlX EPAReg No}file Symbol 705Q6. Product: BifenthrinTechnical InsecticideJMiticide

MRID Number Submitter Status



### • • 

### ••• • 

## • • • 

# · • • • 

## • • • 

## • • •

• CITE-ALL GITIl-ALL CITE-ALL CITE-ALL CITE ALL CITE ALL CITIl-ALL CITE ALL CITE-ALL CITE-ALL CITE ALL CITE ALL CITE ALL
CITE ALL
CITE ALL FMC, Scott<;, Andersons 

### Pa FMC. Scotts. Andersons 

### Pa FMC. Scott.'\., Andersons 

### Pay FMC. Scotts. Anderson.,> 

### Pay FMC. Scotts. Andersons 

### Pay FMC. Scous, Andersons 

### Pay FMC. Scotts. Andersons 

### Pay MC. Scotts, Andersons 

### Pa FMC, Scons. Andersoos 

### Pay FMC. Seotts. Andersons 

### I pay Pyrethroid Working Group 

### I pay FMC, Scott.'\., Andersoos 

### Pay UPI is a member ofthe Ag Re-entry task Own force; UPI is a member oflhe Outdoor Residential Task Force UPI is a member ofthe Ag Re-entry task Own 

### rorce: UPI is a member ofthe Outdoor Residential Task Force UPI is a member ofthe Spray DriftTask**O.~** Force

Name and TItle Elizabeth Anne Bro
.... 

### n. OlemReg International. LLC Registration Agent 

# I Page30f3

Note

Date 4111/2002 EPA Fom18570-35 (9·97) 

### EliiCironlc and Paper \'ersioniivailable. Submit only Paper version. 

# - Agency Internal Use Copy**~-.--.----.-.----**

## • •

hours per response for reregistration burden estimate

United Phosphorus. 

### Inc. 423 Riverview Plaza Trenton, NJ ( Ingredient E



### N CJ1 

### CDSignmure

### ~dM.<.~.J anNITEDSTAT1lS ENVIRONMENTAL ..dIII\."CTION AGENCY

.... 4OIMSt
....

### ~S.W.~ average completing the necessary form.<;. Send comments regarding the 10: Director, OWE Information Management Division (2137),

Name and Tille Jrd" Eli7.abelh Anne Brown. ChcroReg Imemmional. LLC 411112002 Rcgislnuion Agent EPA Fonn 8570·35**(9~97j** Electronic illl"iI Paper \-ersionSiiviiilabte. Submit only Paperversion. Public File Copy

# '.

hours perresponse for reregistration and special burden estimate or any other ao;oect ofthis collection

Signature

### ~j"""~dML.**~,J** • NITEDSTATI!S ENVIRONMENTAL .ECI'lONAGENCY 401 MStreet,S.WY
time necessary forms. Sendcomments regarding Ihe Director. OPPEInformalion Management Division (2137),

Name and Title 

# I Dale Elizabeth Anne Brown, ChemReg Inrematioll.11, LLC 411112002 Registration Agent EPA Form 8570-35 19-97) Electronic and Paperversions available. Submit only Paper version. -Public File Copy

### [ I;;..,···...,.
...... Form Approved QMB No. 2Q7O..OO6O 

# I

- allNlTEDSTATFS

### ENVIRONMENTAL~crION AGENI..'Y

.... 461
for reregistration and special review activities, orany other tt'q)eCt ofthis collection ofinformation,. •

Phospborus, Inc. 423 Riverview P1aza



### N 0) -" Signature

### ~a:u..~,J EPA Form 8570·35**(9~97)** Electronic lllId Paper-versions aV'diiable. Submit only Paper version. the necessary forms. Send comments regarding the Director, OPPElnfonnation Management Division (2137),

Name and Title Date Elizabeth Anne Brown. ChemRcg International, LLC 4/1 112002 Registration Agent Public File Copy

# .UPI United Phosphorus, Inc.

423 Riverview Piau Trenton, NJ 08611 (609) 392..s200 x 18 (phone) (609)392-080' (f>x) 

### Remca A. Clemmer Regulatory Affairs Manager



### Mr. George LaRoeca (PM 13) Document Processing Desk (APPL) Office ofPesticide Progmms (7504C) U.S. Environmental Protections Agency 1801 Ben Street Arlington. VA 22202 November2. 2004

Re: Bifenthrin Te<:hnicallnsecticide, EPA Reg. No. 10506--18 Submission ofProduction Infonnation 

### Dear Mr. 

### LaRocca: In 

### its Notice ofPesticide Registration, USEPA required United Phosphorus to submit production infonnation for this product for the 2004 fiscal 

### year. This product is manufactured by

### United Phosphorus 

### In India, and 

### we hereby report that between the dales ofSept. 30. 2003 and October 1,2004, we have imported ofBifenthrinTcchnical. No data 

### are being submitted with this application and no fees are applicable under the 

### requirements ofPRJ A. 

### Please contact me Ifyou have any questions. Very truly yours.

Rebecca A. Clemmer**rnlemmer@upi~uS!l.com** 

### ••••• 

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