EPA Registration 70506-18 

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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 of Storage Stability and Corrosion Characteristics Study 

BifenUmn Technical InsecticidelMiticide 

EPA Reg. 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. 

!fyou have any questions regarding this action, please contact BeWanda 

Alexander of my 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 subj ect 

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) 

Document Pf?CCIssing Desk 

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 

of the registration ofUPI Bifenthrin Te¢hniea~ 

48414201 StOrage Stability and Corrosion Characteristics ofBifenthrin Technical 

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

May 29,2004. 113 p . 

, )mclosed you will find three copies of the study. This letter will serve as the transmittal 

,document " 

Please contact me if you have any questions. 

Very truly yours, 

·~a.~ 

Rebecca-A. Clemmer 

tcleTmner@ypi·usa,!XWl' 

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File: RAC-2004-040 

)!ifeJl!luin Technical Re~tioo File 

CC: A. Tilhnan 

J. PritchBr4 

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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.?ocument frocessing Desk" , Office ofPesticide Programs (7504C) 

U.S. EnWonmcntalProtections Agency 

1921 reffetson DayisHighway 

Arllngion. VA 22202 

En: Submission of Sludy 

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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 

of the regiBtration ofuPlBifenlhrin Technical: 

46414201 Storage Stability and Corrosion charaCteristics ofBifenthrin Technical 

(Interim Report-12 Months). United Phosphorus. Inc., Study 4210, 

May29,2004.113p. 

).!nclosed you will find three copies of the study .. TIus letter will serve as the transmittal 

,document;, 

Please CO,ntAct me if you have any questions. • • > • 

Very truly yours, 

~Q.~ Enbecca A. Clemmer 

Cclcmmer@tmi-uslLcom 

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RAC-2~O 

Jlifenthrin. technical Registration File 

A. Tillman 

.. J. ~ritchard 

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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

WASHINGTON, D.C. 20460 

UNITED PHOSPHORUS INC 

423 RIVERVlEWPLAZA 

TRENTON, NJ 08611 

December I, 2004 

Report of Analysis 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 of the material. The results are provided as follows: 

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

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

Master Record ID's (MRIDs) assigned to each document submitted. Please use these numbers in 

all future references to these documents. Thank you for your cooperation. If you have any 

questions concerning this data submission, please raise them with the cognizant Product Manager, 

to whom the data have been released . 

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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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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

WASHINGTON, D.C. 20460 

UNITED PHOSPHORUS INC 

423 RJVERVIEW PLAZA 

TRENTON, NJ 08611 

June 16,2004 

Report of Analysis 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 of the 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 of your bibliography. 

Rejecled Study [OIl: 

• Judging from the pagination of the study. page 81 was omitted from the submitted 

copy . 

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..uP' United Phosphorus, Inc. 

423 RIverview Plaza 

Trenton. NJ 08611 

(609) 392-3200 x (8 (pbone) 

(609) 392-0808 (fhx) 

Rebecca A. Clemmer 

Regulatory AJ'falrs Manager 

Mr, George LaRocca (PM 13) 

Document Processing Desk 

Office ~fPesticide Programs (7504C) 

U.S, Environmental Protections Agency 

1921 Jefferson Davis Highway 

Arlington, VA 22202 

Re: Submission of Study 

Bifen!hrin Technical (EPA Reg. No. 70506-18) 

Dear Mr. LeRooca: 

June 9, 2004 

Enclosed please find a storage stability and corrosion characteristics study, submitted in support 

of !he registration ofUPI Bifenthrin Technical: 

Reject (01) Storage Stability and Corrosion Characteristics ofBifcn1hrln Technical 

(Interim Report-12 Months). United Phosphorus,lne., Study 4210, 

May 29, 2004. 113 p . 

Enclosed you will fmd three copies of the study. This letter will serve as the transmittaJ 

document. 

Please contact me if you have any questions. 

Very truly yours, 

~Q.~ Rebecca A. Clemmer 

rc!emmer@uDi~uM!com 

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File: 

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 of Analysis 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 staff has completed a preliminary 

analysis of the 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. If deficiencies 

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 of your bibliography. 

Rejected Study [01]: * JUdging from the pagination of the 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) 

Document Processing Desk 

Office of Pesticide 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 a storage stability and corrosion characteristics study, submitted in support 

of the registration ofUPI Bifenthrin 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 of tho study. This letter will serve as the transmittal 

document 

Please contact me if you have any questions. 

Very tru1y yours, 

~Q.~ Rebeeca A. Clenuner 

rctemmer@upi-usa,COID 

RAC-2004-040 

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File: RAC-2004-040 

Bifenthrin Technical Registration File 

CC: A. Tillman 

J. Pritchard 

RAC.2004-040 

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H.,.01-2004 oa,aT.. Fr ... ~ITEO 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 of the 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. 

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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 of Pesticide Programs (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 

of the registration ofUPI Bifenthrin 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 of the 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 

Bifenthrin Technical 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 of Pesticide Programs (7504C) 

U.S. Environmental Protection Agency 

Room 266A, Crystal Mall 2 

19211efferson Davis Highway 

Arlington, VA 22202 

Dear Mr. LaRocca: 

This letter is 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 

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"'ft.') . 1~4 .. \!~. 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. A true" and correct copy of the product label 

approved by EPA Is attached to accompany this letter . 

Roglstration of this product(s) with EPA also denote' that the registrant listed below is 

responsible- for ensuri,ng full compliariee 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 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) 

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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 

If Swallowed • 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 doctor for 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 dqfeIj/ 

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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 accordance with 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 or through 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 orthoroughly washed before use. Expo6&d foods should be coverod or removed. 

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 ... for which US. EPA has accepted the requfred data andlor citation of data that the formulator 

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 of mach of children and anlmais. Store In original containers only. Store In a cool, 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, or feed 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 a vIolation fo Federal law. Olspose o[ excess 

waste orpeatleJdo by use accordIng to label dlroctlons, or contact your State PesUcIde or Environmental 

Control Agency, orthe Hazardous Wasto roprosentatlve at tho nearest EPA Regional 0f1lc0 for guidance. . . 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 only warranty 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 

Dear Mr. 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 Be Insecticide 

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. A true 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 of this 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) 

Document Processing Desk (Final Printed Labeling) 

Office of Pesticide Programs{7504C) 

U.S. Environmental Protections Agency 

Ariel Rios Building 

1200 Pennsylvania Ave., N.W. 

Washington, D.C. 20460 

Re: Fin.l Printed Label 

July 27, 2004 

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

o.ar Mr. LaRDcca: 

Enclosed for your files please find 5 copies affinal printed labeling for the subject product It 

incorpomtes changes approved by the Agency in January 2004. Because of the size and shape of 

the nctuallabcl. it has been cut to fit onto 8 ~ x 11'1 paper. 

Please contact me if you have any questions. 

Very truly yours, 

Rebecca A. Clemmer 

rclemJD<ir@upi-usa,CQm .. " .. 

• • •• • • 

• •••• • • • • 

•• • • • • • • 

.. • .. • , • 

• 

.. . • • • • 

• ••• 

.. , 

... ..... • 

28 

= 
&EPA 

United States 

Environmental Prot&cUon Agency 

EPARogNo. 

Product Name 

ResubmlSslon In response to Agency lDtterdated ___ _ D "Me Too· Application 

D Notlflco,'Uon - Explain bel~ D Other - ExplaIn below 

No 

bo submitted Unit Packaging wgl 

tbe-stAttments I hive madt on this (orm aDd .lIattachm~nts thmto are 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 

of the label is enclosed for your records. Please submit two copies of your 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 ..................................... ,", ............... " ...... " .......................... , ............... ,.", ...... ,., .................... , 100.00A, 

·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. 

If swallowed 0 Call a polson control center or doctor Immedletely for treatment advice. 0 Have person sip·a glass of water If able 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. 

If Inhaled 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, If possible. 

Call a son control center or doctor for further treatment advice. 

I If on skin or clothing 0 Take off contaminated clothing. 0 Rinse skin Immediately with plenty of water for 15-20 minutes 

I 0 Call a noison control center or doctor for treatment advice. 

If In eyes 0 Hold eye open and rinse slowly and genUy with walerfor 15-20 minutes. 

I • Remove contact lenses, If present, after the first 5 minutes, then continue 

rinsing eye. 

0 Call a-o01son control center or doctor for 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 be fatal If swallowed. Harmful If Inhaled 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 

of a National Pollutant Discharge Eliminations System (NPOES) permit and the permitting authority has 

Page 1 

31 
• 

• 

...... ~.~.--------~. ---------

been noOOed In writing prior to 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 of the Environmental Protection Agency. 

Physical/Chemical Hazards 

00 not use or store ncar heat or open flame. 

DIRECTIONS FOR USE 

II Isa violation of Federal 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 Nut Trees 

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 or through which Insects may enter 

can be treated. Examples of non-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 of food 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 

or thoroughly washed before uso. Exposed foods should be covered or removed. Examples of food 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 for which U.S. EPA has accepted the roqulred data andlor citation of data that tho 

formulator has submitted In support of registration; and 

(3) USGS forexporlmentat purposes thataro In compliance wtth U.S. EPA requirements. 

Formulators ualng this productaro responsible for obtaining U.S. EPA registration for theIr 

formulated product which may be labeled for tho use patterns as found listed on this labol. 

Page 2 

32 
-

Storage and Disposal 

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

PESTICIDE STORAGE 

Keep out of reach of chlldren 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 or drink containers. Do not contaminate other pesllcldes, fertilizers, 

water, food, or feed by storage or disposal. 

In case of sp11l. 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 of excess pesticide, spray mixture, or rlnaBte Is a violation fo Federal law. Dispose of excess 

waste or pesticide by use according to label directions, or contact 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 of liner In e sanitary landfill or by Incineration, If allowed 

by Stale and local authorltJes, If drum 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 of January 7, 2004, and on behalf of our 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 red line 

data matrix - Agency Use 

data matrix - Public File Copy 

e The certification with respect to citation of data previously filed for this amendment covers any 

changes in the data matrix; anew certification will not be filed unless you let me know 

otherwise. 

• 

Thanks very much. Please let me know if there is anything else that is needed. Would you 

please acknowledge safe receipt of this 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 & Regulatory Affairs 

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 or otherwise 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. If you 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 per response for reregistration and special review activities, including time for reading the instruction and completing the necessary forms. Send comments regarding the 

burden estimate 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.. NI 08611 

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 of limits 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. 

W ASHINGTQN. D.C. 20460 

Form Approved OMB No. 2070-0060 

Paperwork Reduction Ad Noflce:-The public reporting-bUrden forthis collection ofinfonnation is estiillated to average 0.25houtS per response for registration activities and 025 

hours per response for reregistration and special review activities. including time for reading the instruction and completing the necessary forms. Send comments regarding the 

burden estimate or any other aspect of this collection of information. including suggestions for reducing the burden to: Director. OPPE Information Management Division (2137), 

U.s. Environmental Protection 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~ 

I Boiling 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 • 

rE, UPI - ,J~~Us. ---------- Own ~ 

i45505 UPI Own t 00155286 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 
· ~") ~ .NITED STATES ENVIRONMENTAL P.ECI10N AGENCY 

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 of inform at Jon 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 of this collection of infonnation. 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. 

DATA MATRIX 

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 

Paperwork Reduction Act Notice: The public reporting burden for this collection of information is estimated to average 0.25 hours per response for registration activities and 0.25 

hours per response for reregistration and specia1 review activities. including time for reading the instruction and completing the necessary fo,rms. Send comments regarding the 

burden estimate or any other aspect of this collection ofinfoonation. including suggestions for reducing the burden to: Director, OPPE Information Management Division (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 NoJ File 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 Study Name 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 of tile 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 of the Ag Re-entry task Own 

, force; UPI is a member of the Outdoor 

Residential Task Force 

201-1, 202~1 (840.1100, Spray drift and droplet size CITE ALL UPI is a member of the Spray Drift Task Own 

835.4200) Fo= 

171-4a Nature of residue - plants ClTEALL FMC Pay 

171-4b Nature of residue 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 of residues meatimilklpoultry/egg ClTEALL FMC Pa 

171-4k Magnitude of residues field crop trials ClTEALL FMC.IR4 Pay 

17141 Magnitude of residues - 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 per response for reregistration 

burden estimate or 

Phosphorus, £nc. 

423 Riverview Plaza 

Signature 

.. ~~~ 

eNITED STATES ENVI!~~'.!E'rr.A"L.~.CTION AGENCY 

per response 

review activities. including time for reading the instruction and completing the necessary forms. Send comments regarding the 

of information. 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 for reregistration and special 

burden estimate or any other 

Date: Januarv 9. 2004 

. Inc. 

423 Riverview Plaza 

Trenton. NJ ( 

Ingredient; E 

Signature 

~tZu.L~ 

.NITED STATES ENVIRONMENTAL P.CTION AGENCY' 

401 M Street. S. W. 

time 

per 

instruction and necessary forms. Send comments regarding the 

Director, OPPE Information Management Division (2137), 

Name and· Title Dote 

Elizabeth Anne Brown, ChemReg International, LLC 1/412004 

Registration Agent 

EPA Form 8570~35 (9~97) Electronic and Paper versions available. Submit only Paper version. Public File Copy 
~ 

~ .NITED STATES 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 per response 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 of this collection of information, 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 or any other aspect of this 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, or goIng for 

treatment. 

11 'Swallowed • Call a polson control conter or doctor [mmadlately for treatment advlce./ 

• Have person sip a glass of water 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~ 

• If person Is nQt breathing, call 911 or an ambulance, then give ertlfi '/ 

respiration, preferably mouth·to·mouth, If possible. 

• Call a nolson control center or doctor for further treatment advice. 

If on skln or c[othlng • Take off contaminated clothing: /" 

• R[nse skin Immediately with plenty ot water for 15-20 minutes 

• Call a ootson control center or doctor for treatment advlco. 

[f in eyes • Hold eye open and rinse slowly and gently with water for 15-~~tes. 

Remove contact lenses, If presen1, alter the first 5 minutes, the ntinue 

rtns[ng eye. 

• CaI[ a-oo[son control center or.doctor for 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 If swallowed. Harmful If Inhaled or ebsorbed 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 

of a 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 without previously notIfyIng the sewage treatmanl plant authority. For guidance. corrtact your state/" 

Water Board or AeglonaJ OffICe of tho 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 a spol 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 (after canning and bottling). 

FoodIFeed Areas: May mt be used to manufacture products for use In loodIfaed ereas. 00 not use In lood 

areas of food 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. 

formulator 

(2) UIH for 

has 

which 

submitted 

U.S. EPA 

In 

has 

support 

accepted 

of tegIBtraUon;·and 

tha required data and/or citation of data that ~ 

(3) Usee for experfmental purposes that are In compllanC<! with U,S. EPA requirements. ~ 

Fonnulators usIng this product are reeponslble for obtalnlng U.S. EPA registration for their / 

formulated product whIch may be labeled for the use pattoma 8$ found listed on this label. 

Page 2 

46 
I < 

storage and DIsposal 

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

PESTICIDE STORAGE 

Keep out of reach of children and animals. Siore In original containers only. Store In a cool, dry place a~rv V 

avold excess heat C~refuny open containers. After partial use, replace lids and close tightly. Do not put 

concentrate 

__ or m ___ 

dilute material Into w__ food or drink containers. Do not contaminate other pestieldes, fertilizers, ~ 

In case of spl!!. avoid contact, Isolate area, and.keep out animals and unproJected persons. Connne sis. 

PESTICIDE DISPOSAL 

Pesticide wastes are toxic. 00 not contaminate water, food or feed 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 your State Pesticide or Envlronrn a! 

Control Agency, or the Hazardous Waste representative at the nearest EPA r;l:eglonat Office for guidance, 

• 

Completely 

CONTAINER 

empty 

DISPOSAL 

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!! or by 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 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 WRmEN STATEMENTS OR 

REPRESENTATIONS. 

Page4 

EPA Approved. 08125/2003 

Revision (notification): 09105/2003 

Omft Amendment: 10102/2003 

48 
- ---- Ii:: Ii:: 

- .. -

- ... ... --:::J. ----... Ii:: 

... 

• 
---~~~ --~- ---.".--;------

(e I'BdIU. Oct. It. lilt. •• "cf:llldtd ............ "_n.lUa. 111M. lIAft.1SIII;. II J'B.HID8,.rau II, 11111 '118.!00 .... ' ' ....... 11; ... ' 

fI.te (.) data 

Table. 

reqafrem6Dw 

8taUou 1111.11 

&Dd 

UI4 

the .. 

ut.UIO , PM Uuoadl 

to be 

111.111 

tertte4. 

tIcearibo how to tIM thfa table to 4otemdao the ~ 

UI'IIilI'lcIft""""" 

-"'--1--1" 

---1--1 

[CO J'Jt tIIIIIl~ Oct. Sf. U1IK. ~ted at; • FAl!IIIG8,. .,. of. UII] 

......................... <a> Table. SocttoualtlUO -

aDdl&8.l00 thro h 168 102 d 

requ1remonto and the aubstance to be tN~ . oecr:tbo how to 1LIe thhs table to dttermJ.tto the t4l:1coI08"1 dAta 

/(,/-3 ;<;';;r"""'< 4 __ " """tH,>/,l.d 'I' ,..-/(C ,$"J/ "";{.. /63-.a. - ,. 

" 50 

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I 

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.............. -..... -

Ca) Table. Bocttone 158.10 a.D4 158.100 UlroOCh BaJa deecrtbe how to UN th1I table to detonD1ae the &er1tJ Ipr&J' drUt data roqu1rtmelltl &D4 the aubltazsoe to be teatocL 

-,~~,-

r_ .. dill, Oct. it 1M ~ted at &l J'&utGt. w.a,. •• lS88.1U1d -.mtnded at 61 ntH3:11. .1lWI23.1\IIII} 'lUMO WlIdUte aDd aquaUcorpn ..... data ~ 

(Il) TAble. Soct1ona 168.60 ADd 168.100 throuch lMJ02 4eaoribe how to UN thJa tabJe to determine tbe W1Idl1!e and aquatic orrantllnl data. req,u1rementalD4 the Itlbat&aco to be tuted . 

........ - AwIM __ 

.... 

-

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U ..... PI.at .... I'dkn .... nqab: II. 

(a) Table. 8ect1ODa HUO aa4 U8.1DO tbro\llh m.tDa 4eaor1be boW to ue WI tr.blt to 4eterm.1De tho plant probtotton d&ta req1llrementl and tbe aubItmoe to be teIte4.. 

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(&) 'l'&b1e. 8eoUoullUO aad.1I8.lOI1 throMtllllJII 4eectibe how to 1110 wa table to dotonn1llt tho JI4lltu"rU 11leeot ... ~U14 tbt nbdaDootobtteete4. 

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-

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- J:l ---- J:l -. --- -

-- J:l - ''''"- 1'A/A4 - 'c:. I 

- -... -"10: . ..... ....a""- ~.~ 

... 

I 

r 

I 

f 
oEPA United Statu 

Environmental Protection Agency 

(b){I),my 

to: 

EPA Rog No. 

Amendment 

Other 

279=3055 

Product Name Bllen\hrin Techn!callnsectlckle/Millck:la 

o RosubmfMlon In response to Agency letter dated 

NotHk:a.tlon - Explain below 

Unit Packaging wgt 

I cer1ll'y thatlhe smiemmlll 

• 1 

1-'6j"".u~ ~ 

8lzabolh Anne Brown 

Aaaocv letter dated ~ "Me Too- Application 

o Other - Explain below 

I. 

Ves 

No 

PackagOwgt 

LtC 

roaponso 

may be punishable by nne or ImprisonmMt or 

ChemReg IntemaliOnal, LLC 

Aulhorlzod Agont 

October 6, 2003 

p,..", 

01"" 

popo, 

Other (SpecIlY)I __ _ 

C'Y>'l'~"') 

• 

••• , •••• 

• 

••• • • ••• t-

• 

• ••• 

• ••• • 

• • •• •• 

56 
"ft. .... 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 othor aspect 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 ~ 1 run 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 offer and 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, If tho ello-all optlon orelle-all option under the 

, '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 I am the original data eubmltter or 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 of this 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 their delivery In 

accoroanco with secllons 3{c)(1 )(F) and/or 3(c)(2)(8) 01 AFRAaro available and Will be submitted 10 the Agency upon requesl. Should Ilnl! to produce 

such evidence to the Agency upon request, I understand that the Agency meylnlilole action 10 deny, cancel or suspend tho reglslrallon 01 my product In 

confonnlty with AFRA. 

I t*rtlfythat tha statomonta I have made on this form and all attachments to It ere 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.' ,I 0"""" 

. "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 of Pesticide 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. . 

If you have any questions, please contact Registration Division, Risk Management Team 

3, at (703) 305·6788. 

Sincerely, 

Front End 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 of this collection of i 

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

I Dale: 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 of limits . __ ........... ,.....". 

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

J. ,(., 

ammo STATES 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 

~ •• _ ..... & Noi Hie 

,\<.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 I FMC. 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{) 

-..ITED S1:ATES ENVIRONMENTAL P~ON AGENCY 

'111'" 401 MStree~ S.W:"'III'---

WASHINGTON,D.C. ~ 

Paperwork. Reductioa Act Notfce: The publie reporting bwden for this collection of infonnation is estimated toi-,"~·o.2S boUts 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 fonns. Send comments regarding the 

burden estimate or any other aspect of this collection of information. including suggestions for reducing the·burden to: Director. OPPE information Management Division (2137), 

U.S. Environmental Protection A~ency. 401 M Street. 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 

.l Acute denrutl:- rabbit/rat 

ry dennal irritation - rabbit 

Dermal sensitization 

+. Acute neurotnxicitv 

~t1....u-~ 

DATAMATRlX 

I MRJDI 

EPA Reg NoJ File Symbol 

705Q6.I8 

Product: Bifenthrin TechnicallnsecticidelMitieide 

StatuS 

-T ......... "...... UPI Own 

I Page 2 of4 

iNOte 

45838001 UPI Own I I 

45838001 ·UPI . Own 

45838001 UPI Own 

4583&001 UPI own 

CITE ALL . FMC. Scotts. Andetrons Pav 

Pay 

FMC. Scans. Andersons Pay 

FMC. Scotts. Andersons Pay 

CITE ALL FMC. Scotts. Andersons Pay 

CITE ALL 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 

Fonn Approved 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 of litis collection of informatioo. 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 Study Name 

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 Nol File Symbol 

70506-18 

Product: Bifenthrin TecbnicallnsccticidetM:iticide 

:lTE-tu...J... I r 

...... ~-

:lTEAJ 

:lTE-, 

:ITEJ 

:. Seous. 

I FMC. Scotts. j 

'Yrethroid We 

'Me. Scotts •. 

Name and Title 

l!"l' 

Elizabeth Anne Brown. ChemReg Jnlcmational. LLC 

Registration Agent 

P:age 3 of 4 

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"ITED STATES ENVIRONMENTAL PRrON AGENCY 

401 MS ....... S.W. 

WASHINGTON. D.C. 20460 . Paperwork. Reduction Act Notice: The public reponing burden Cot' this collection o(jnformation is estimated to average 0.25 hours per response for registmdon activities and 0.25 

hours per response for reregistration and special review activities. including time for reading the instruction and completing the necessary (onns. Send comments regarding the . burden estimate or any other aspect oHhis collection ofinfonnation. including suggestions-for reducing 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 

Ingredieot: Bi(cnthrin (PC 128825) 1 

, 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 of the Outdoor . Resk1ential TaskForce 

1334 (857.2500) Inhalation exposure CITBAIL UPI is 8 member of !he Ag Re-entry task Own 

</' force; UPI is a member of the 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 of residue - !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 of residues mcatI . {egg CITBAI.I. FMC Pay 

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

171-41 \ Magnitude of residues - 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 Copy 
hours per response for reregistration and special review 

burden estimate or any other aspect of this collection 

Signature 

~}.,....,~~ 

.ITED STATES ENVIRONMENTAL P~ION AGENCY 

401 M Street, S.W. 

lime 

to average 

in.'\truction and completing the 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 Paper version. Public Flle Copy 

------~-~ _. ~-'"'- .. ~,---,-~--~---
~ r"Ol1ll Approved OMB No. 2070-0060 

oIIIIIiNlTED STATES ENVIRONMENTAL PI!,IIIIII':CTlON AGENCY 

.. 4OIMS_~S.W." 

WASWNGTON. D.C 20460 

Paperwork Reduction Act Notice: 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 the instruction and completing the necessary forms. Send conunents regarding the 

bunlen estimale or any other aspect of this collection of information. including suggestions for reducing the burden to: Director, OPPE Information Management Division (2137), 

U.S. Environmental Protection AftCncv. 401 M Street. 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 

EPA Reg NoJ File Symbol 

7051J6.18 

Product: Bifenthrin TechniciI InsecticideJMjticide 

E1i1.abcth Anne Brown. CbemReg International. LLC 

Page2of4 

911712003 

, 

I 
hours per response 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 Paper version. PubUc File Copy 
and 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 

ELIZABETH A. BROWN, PH_D_ 

Sep.ember 5, 2003 

Document Processing Desk (NOTlF) 

Office of Pesticide 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 of Other Labeling Revisions. Bifenthrin Technical InsecticidelMiticide. 

EPA Reg. No. 70506-18 

Dear Sherarla: 

On behalf of our client, United Phosphorus, Inc., we are notifying for a change in the 

medical emergency contact pbone 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 of the protiuc. labeling with changes highlighted. 

Please let me know if you have any questions about the enclosed items. 

Regards, 

~ ... ..,tt.v...~ 

Elizabeth Anne Brown 

cc: United Phosphorus. Inc. 

CONSULTANTS TO sucCESS'" 

. •••• •• ., • • 

••• ••• • • •• 

••••• • • ••••• 

• ••• 

• • •••• 

., 

• •• . •••• 

• 

•••• • • ••• • 

• ••• • •• •• • 

• 

•••• • • •••• 

• • • •• •• •• 

Over One Hundred and Fifty Years of Combined Experienee Assisting Chemical, Pesticide, 

Bio~Chemieal and Life Science Companies on a Wide Range of Issues, Including Regulatory 

Strategies, Registration, Data Support and Compensation, Quality Assuranee, Study Des~ 

and ScientifieMatters. 07 
1990 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 of Pesticide 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 behalf of our 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 similar product EPA 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 of Datu 

3. EPA Form 8570-34, Public File and Agency Use copies 

4. Five (5) copies of the 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. 

. •••••• ., • • 

•••••• • • •• 

••••• 

• • •••••• 

• 

•••• 

• • •••• 

• 

•••• • • • ••• 

•••• • •• •• • 

•• • CONSULTANISTOSUCC~ ••••• • ••• 

• • Over One Hundred and FiftyYenrs of Combined Experience Assisting Chemical, Pesti<!iUl, 

Bio-Chemica1 and Life Science Companies on a Wide Range of Issues, Including Regu1Jft~ 

Strategies, Registration, Data Support and Compensation, Quality Assurance, Study DM • 

and Scientifie Matters. 


• 

oEPA UnIted States 

Environmental Protection Agency 

o None Rtlstrlcted 

2Z9=3Q55 

Chock If tills Is a new addross 

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 

G ... 

Pape, 

Othor (Specify), __ _ 

(Stamped) 

• • •••••• • 

•••• • • •••• 

, i 

• • .. ..... _ 

• • • •••• 

•••• • • •••• 

• .. ' • . 171 

• 
.--;----,--~-------------.-.-.. 

• 

• 

• 

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 of Pesticide 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 behalf of our clien~ United Phosphorus, Inc., enclosed please find 3 copies of the final 

printed labeling for the above ProdUC4 per the notice. of registration dated August 25, 2003. 

Please let me know if you have any questions. 

Regards, 

• ~ tt..J.Jf,&.~mJ 

Elizabeth Anne Brown 

cc: United Phosphorus, Inc. 

CONSULTANTS TO suCCESS'" 

• • •••••• • 

•••• • • •••• 

• 

• • •••••• • 

•••• · " " . Over One Hundred and Fifty Years QfCombined Experience Assisting Chemical, p~s . rude, 

Bio-Chemical and Ufe Science Companies on a Wide Range of Issues, Including R ~tPrY Strategies, Registration, Data Support and Compensation, Quality Assurance, Study es\s.r! 

and Scientifie Matters. ' •••• :{ 2 

• ••••• • •• • • 

• ••••• • • " 

• •••• • • ••••• 
. '. .. 

A EPA· '0 . 

United Phosphorus, Inc. 

423 Riverview Plaza 

Trenton, NJ 08611 

Untted Statos 

Environmental Protection Agency 

, 

(b)O). 

to: 

EPA Rog No. 

Amendment 

Other 

Restricted 

Chock If this Is 11 new Ilddtess Product Name 

Notif\catlOfl. - Explain below 

por 98-10. 

Yes y", 

No No 

must 

be submItted wgt 

Container 

Enzabolh Anne 8rown 

I , 

Aooncv [etter dated o "Me Too· AppllcaUon 

o Othcr- Explain below 

40 CFA 152.46, end no otherchangos have boon modo 

a violation of 1 B U.S.C. Sec. 1001 to Willfully mako any 

terms of PA 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) 

• 

•••• • ..... • 

• • • • • •• •• 

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 pol son control center or c!octor, or going for 

treatment. 

II swallowed • Call a polson control center or do etor immediately for treatment advice. 

• Have person sip a glass 01 water II able to swallow. 

• 00 no1lnduce vomiting unless tol d to do so by a polson conlrol center or 

doctor. 

• 00 not alve alve anVlhlna bv mou th 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, If possible. 

• Cail a on control center or doctor for further treatment advlCi!. 

If on skin or clothing • Take of! contamlneted clothing. 

• Rinse sldn Immediately with plen ty of water for 15-20 minutes 

• Call a DOison controt center or doctor lor treatment advice. 

II In eyes • Hold eye open and rinse slowly and gently wilh water for 1&20 minutes. 

Remove contact lenses, If prasen t, alter the first 5 minutes, then continue 

rinsing eye. 

• Cell a ooison control canter or do etor 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 of the 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 InconsIstent with Its labeling. 

This material requires further mixing before use 

Onlv for formulation 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-of food handling establishments, restaurants, or other areas where food Is commercially prepared or 

processed. 00 not use In serving at'e<!S while food Is exposed or facility 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 be covered during treatmenl 

or thoroughly washed before use. Exposed foods should be covered or removed. Examples of food 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 for which 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 for their 

formulated prodUct which may be labeled for the use patterns 85 found listed on this label. 

Page 2 

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Storage and Disposal 

Do not contaminate water, food, or feed 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 or feed 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, or the 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 or by 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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77 
, 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..- or l'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 bbelins 4iffai .... ill ~ rrom thai KUpUd in ~ II-ilh \hU; ~UOfl mlm ~ submitted 10 I!Id ~ by the ~Wlltion Division 

prior III \U(' oClhcI WocI in comlllCf'l;e. IA iUIY ~ 011 this pruclvcl always ~rer 10 !hi: .bow: EPA ~JUtrnion number. 

On the buis oCinronndion runu~ by the ~ the &bow: !111M<! peslieidl: ;, hereby RgiJlcml/~retisten:d UIIdtt!be Fedaalln:$«Iieide. FUIlpeide and ROIknlili&: > - ! A ... 

RqirIration is in 110 way 10 be coratnxId II an ~ or =mmc!ldaUOll orlhis prodUCl by the: AIft\CY. In orokr 10 proICCt ImIIh I!Id the mvircnmCnt, the: AcInI~. 011 bil motion. ou.)I ... 1lIIY tinIc NfllCIId or an«1 the rqistn.tiC!ll or. p¢$lielde in ~ willi the An The aeteptMct or any name in toI\MCtion wilh 

!be rqIS!lIIion or. produd UIldtr this Act Is ROllO be «II!StnICd lIS ;ivins the ~;iJtram I ""'110 tlCe!usive uw orthc: Mrm: 01' 10 ItJ lISt Irll has 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 of your product 

under FIFRA sec. 3( cXS) when the Agency requires all registrants of similar products to submit 

such data; and submit acceptable responses required for reregistration of you product under 

FIFRA section 4. 

2. Yau have applied for the registration of a product containing the active ingredient bifenthrin. 

The Agency has recently conditioned the original registration of which you are a follow-on with 

a new data requirement. A copy of EPA's letter, dnted May 7, 2003, notifying FMC 

Corporation of the 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. or you may offer to share with other registrants the cost of conducting testing. 

The data requirement being imposed on this registration is as follows: 

~;M:~J.- t:-" 

!hie: 

-r. L ... -;l?{JI!<!'" AUG 25 2003 

EP A Fcnnl~ 
. 

, , , 

• 

• 

" , .- , -> '-",' ",','--' " --- - ------------ --- --~----~--

. ACCEPT 

with COl\lME 

In EPA Letter D 

ED 

NT8 

aled; 

Blfenthrln Technical PlJ6 25 2003 

InsecticideIMlticlde _Iholi' ....... 

~~fortbo 

hIsoeUW!e, 

~A<:'" 

FOR FORMULATION USE ONLY :!':to2t.!' F~ 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 of water 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 or doctor for furthertroalment advice. 

If on skin or clothing • Take off contaminated ~Iothlng. 

• Rinse skin Immedlately with plenty of water 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, after the 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 
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syslems WIthout previously noUfying the sewage treatmont plant authority. For guidance, contaci your Slate 

Water Board or Regional Office of the Environmental Prolectlon Agency. 

PhysicaVChemlcal Hazards 

00 nol use or slore near heat or open 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 for formulation 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 

Indoor Insect 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: May 1lQ.t be used to manufacture products for use In foodlfeed areas. Do nol use In food 

areas of food handling estabHshments, restaurants, or other areas Where food Is commercially prepared or 

processed. 00 not use In serving araas while food Is exposed or facmty 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 for which U.S. EPA ha. accepted the required data andlor citation of data that the 

formulator has submitted In support of registration; and 

(3) U80sior experimental purpoBGS that ara In compliance with U.S. EPA rel:julromonts. 

Formulators using this product are responsible for obtaining U.S. EPA regIstration forthefr 

formulated product which may be labeled for the use patterns as found listed on this label. 

Page 2 

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o 0 0 o 0 

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.. 0 o 0 0 

.. 0 

o 

o 0 

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.. 0 

o 

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o 0 o 0 0 

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80 
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• 

Storage and Disposal 

Do not contamInate water, food, or feed 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, or feed 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 of excess pestlclda, spray mixture, orrlnsate Is a vlolallon fo Fadera"ew. Dispose of excess 

wasle or pesticide by usa according to label directions, or conlaet your State Pestlclde or Environmental 

Control Agency, or the Hazardous Weste representative 01 the nearest EPA Reglonet Office for guidance. 

CONTAINER DISPOSAL 

Completely empty nnerby shaking and tapping aides and bottom to loosen clinging partlcles. Empty 

residue Into appllcatlon equlpment. Then dispose of nner In a sanitary landfill or by Inclneratlon, If etJowed 

by State and local authorities. It drum Is contamlneted and cannot be 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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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 be followed 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 

•••• • • • 

Page 4 

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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 A 22202-4501 

Attn: George LaRocca (pM 13) 

•••• • •• • • 

· ...... . , •• 

•••• • • ••••• 

Re: Bifenthrin Technichl InsecticidelMiticide (EPA File Symbol 70506-RI) 

Response to Agency letter of August 6, 2003 

Dear George: 

•••• • • •••• 

• 

... • • •• 

• 

• ••••• • 

• • • • .. •• . 

• ••• • • •••• 

• • • • -... 

On behalf of our client, United Phosphorus, !Dc., this letter is in response to the Agency 

letter of August 6. 2003. regarding the above application for registration. 

As a condition of registration, 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 of the data call-in sent to the other registrants or other 

documentation of the Agency requirement to other registrants. (p~ .. e./""*I F",I441 ,~ t/o-,r.lu( F~G / 

/ • .f'~( .... I'/t>J} __ A*,,,,/~...r /I-I!";,f 

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 of Data (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 of this 

application. . 

CONSULTANTS TO SUCCESS"' 

Over One Hundred and Fifty Years of Combined Experience Assisting Chemical, Pesticide, 

Bio-Chemical and life Science Companies on a Wide Range ofIssucs, Including Regulatory 

Stnltegics, Registration, Data Support and Compensation, Quality Assurance, Study DeSWh 

and Scientifie Matters. 00 
• 

• 

Letter to G. LaRocca, August 15, 2003, page 2 

Also enclosed are five copies of the draft label, revised as required in the Agency letter, 

along with one higblighted copy to identify the cbanges. Final printed labeling will be submitted 

once the Agency bas registered this product and prior to release of any product for shipment. 

Thank you for your attention to this matter. Please contact me immediately if there are 

any questions or if anything further is needed. 

Regards, 

Elizabeth Anne Brown 

cc: United Phosphorus. Inc . 

! 

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•••••• • • •• 

••••• • • ••••• 

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No 

'O''''flcs.u"n must 

be submlttod 

Ellzabelh Anne Brown 

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be punishable byflneor lmprlsollDltDt or 

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lOMU 

,.....ft ..... - UNrrED STATES ENVIRONMENTAL PROTECTION AGENCY 

,,~ 401 M STREET. S,W, 

WASHINGTON, D.C. 20460 

Paperwork Reduction Act Notice; The public reporting burden for this collection of 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 of compensallon (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 offer and 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 _,;1 thO, I lIop'on , 

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1 b ;~~~~_~_of ":i~r::;.:,~ In, II ~ ':"~1211 ~_"!~ ~ ,.;;~ ollhl,. 

'~I I I ,...,g~' 

Identical or similar composlUon and usos. 

I certify that for each exclusive use study cited In support of this registration or rerogl8lratlon. thai I am the original data submitter or that I have 

Oblalned tho written pennl$s/on 01 the orfglna! deta Gubmlttedlo clle thaI study. 

I certify thaI 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 of the 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 of thoirdellvery In 

accordance with sections 3(e)(t)(F) and/or 3(e)(2)(9) of F1FRA ere available and will be submitted 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 by fino or Imprisonment of both under appllcablo I\"V':.. • • 

I 

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spectofthlsc_ 

• A_ ..... ". 401 M Street, S.W .. 

t 14, 2003 

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:rtification t 

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w-,,- \,lJV.UWz) Color 

63·3 (830.6303) Physkal stat 

63-4 (830.6304) Odor 

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1

63•51 

63-7 ~ 

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~ 

J OMB No.; 

STATES ENVIRONMENTAL P.CTION AGENC'( 

401 M SI...., S. w. 

:Jforl . . ,-

r. D.C. 2&460 

5 hours per response for I 

.. g the 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. 

I EPA I 

!Unitt 

, UPI 

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, UPI 

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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) i pH 45838001 UPI own I 

Qj)63.13 (831).631,», ••• 'IIabil~y: 45654403 UPI own I - I .. ...... •• .. .. .. .. .. -...... .... .. ...... .... .. • 

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 

.NITED STATES 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: The public reporting burden for this collection of information Is estimated to average 0.25 hours per response for registration activities and 0.25 

hours per response for megistralion and special review activities, including time for reading the instruction and completing the necessmy Conus. Send conunenl$ regarding the 

burden estimate or any other aspect of this collection of information. 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 Reg NoJ File Symbol 1 Page30f4 

70506·18 

Applicant'slRegislrnnt's Name and Address: Product: Bifenthrin Technical InsecticideJMiticide 

United Phosphorus. Inc. 

423 Ri\'crview PI37lt 

Trenton. NJ 08611 

Ingredient: Bifenthrin (PC 128825) 

Guideline Reference Number Guideline Study Name 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 Photodegradation in 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 Ihroid Workin Grot! 

132·1 (857.2100) Foliar residue dissipatioo CITE ALL FMC. Scotts. Andersoos Pa 

ex> 

CD 

• • • ••• • •• • • •• • •• 

• ••• • • ••• •••• • • •••• •• • • • •• • •• • ••• 

• 

Signature Name and Title o.te 

~ ...... ""'-u.. <&..c"".....,. Elizabeth Anne Brown, ChemReg InlcrnationaJ. LLC 8/1412003 

Registration Agent 

EPA Fonn 8570·35 (9·97) Electronic and Papcr versions available. Submit only Paper version, JIgen<)' InIe_ Use Copy 

. 

• 

I 
~~ .rrno STATES ENVIRONMENTAL peECTION AGENCY 

Form Approved OMS No. 2070-0060 

401 M Stree~ S.W. 

WASHINGTON. D.C. 20460 

Paperwork Reduetion Act Notke: The public reporting burden for this collection of infonnation is estimated to average 0.25 hours per response for registratinn activities and 0.25 • 

hours per response 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 other ns:pecl of lhis 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 I Page4of4 

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 oftbe Ag Re-entry task Own 

force; UPI is a member of the 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 of lhe Outdoor 

Residential Task Foree 

201·1.202.1 (840.1100. Spray Wiftand droplet size ClTEALL UPI is a member of the Spray Drift Task Own 

835.4200) I'nKc 

• • •••• • • • • 

• •• •• • • ••• •• • ••• • • ••••• 

• • • ••• • • <D • ••• • • • • ••• 

• • • • • • ••• 0 • • • • •• • • • •• 

• • • • •• • ••• 

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 

Paperwork Redud:ion Ad Notice: The public reportingt'lUtdeii-Cor this collection of infOf'lU!tioniies:limaiCdiO-aVCrage 0.25 hours per response forregistralionactiVities and 0.25 I .. 

hours per response for reregislnUion 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 of information, 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 NoJ File Symbol 

70506-18 

Product: Bifenlhrin Technical 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 of infonnalion is eslimakxf!claVCfage 0.25 hoUrs per response for registration activities and 0.25 I .. 

hours per response [or reregistration and special review activities. including lime for reading lhe imilruclion and completing the necessary forms. Send comments regarding the 

burden estimate or anyotber aspect of this co1leclion of information.. including. suggestions for reducing 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: Bifenthrin Technical 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 of infOrmatiori-is eslimaieifiOivernge-O.25bOurs per response 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 

bunkm estimate or any other aspect of this collection of information. including suggestions for reducing the burden to: Director, OPPE Infonnation Management Division (2137), 

U.S. Environmental Protection NteOCY. 401 M Street, S.W •• Washi!lgtonDC 20460. Do IlOl 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 

• • •• •• • • • •• • 

• 

• 

~~aM.t. ~.,J 

• • • ••• · . .... ., • ••• 

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 
(~ AINITEDSTATES ENVIRONMENTALP.ECTION AGENCY 

.,--' .flit M S ..... ~ S.W. 

Form ApprovcdOMB No, 2070.0060 

WASmNGTON.D.C. 20460 

Paperwork ReductIOn-Act NotiCe: ThCpubllifeponing burden for thlsooHection-()CTDIOfiDatiOfi-iSesilili3iCdtoavcrnge-O.25 hours per response for registration activities and 0.25 

bours per response for reregistration and special review activities,. including lime forreading the instruction and completing the necessary forms. Send comments regarding the 

burden estimate or any other aspect of this collection of infonnation. 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 

•• • ••• •• • • ••• •• • • • •• •• • • •• • • • •••• 

o 0 0 

• • •• •• • •• • • ••• •• o 0 

••• • • • •••• • •••• • • • •• •• • ••• 

~d'.<..u.~ 

DATA MATRIX 

EPA Fonn 8570-35 (9-97) Electronic and Paper versions avliiiab1e~ Submit only Paper version. 

EPA Reg Nol FJ.Je Symbol 

70506-18 

Product Bifcntbrin Technical InscctieideJMiticide 

Name and Tille 

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 20 I 

Lake Ridge, VA 22192-2383 

Dear Ms. Brown: 

AUG 6 21m 

SUBJECT: Application for Registration 

Bifenthrin Technical InsecticidelMiticide 

EPA File Symhol: 70506-RJ 

Y<>ur Resubmission Dated June 11,2003 

OfFICE OF 

PREVENTION, PEST1CIDES 

AND TOXIC SUBSTANCES 

The product referred to ahove mil be 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 of a product containing the active ingredient 

bifenthrln. The Agency bes recently conditioned the original registration of which 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 of conducting testing. 

The data requirement which will be imposed on this regislration is as follows: 

Title of Study 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 of this guideline requirement, the dam you have submitted/cited and 

listed on the data matrix, dated 4/1112002, are adequate to support the proposed uses. 

95 
• 

• 

·2· 

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

paragraph on page 2 of the product label: 

• Change "area" to "areas" near the end of the third line. 

• Change "example" to uexamples" near the end of the sixth line. 

• In the second to last line, insert a period (".") after "(mills, dairies, edible oils, syrups)" 

and capitalize the next word ("Serving'') to indicate the start of a new sentence. 

EPA Reg. No. "70506::18" is being reserved for this product. This must appear on the 

finished label. The ''Notice of Registration" will be issued when three (3) copies of the 

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 of this 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 a copy of this letter with 

your finished labeling. If you have any questions regarding this action, please contact Susan 

Stanton of my team at (703) 305·5218. 

Enclosure 

~urs(7t7t~ George T. LaRocca 

Product~anager(13) 

Insecticide Branch 

Registration Division (7505C) 

96 
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l.a&I- /It!t!'l'-/...I.£ wi".;"""" e.,prm:..(,on.r 

,91'1 po;; 0 

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 

• 

• Have person sip a glass of water If able to swallow, 

Ii, 

• 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 througK tha 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 or store near heat or open flam¥. 

DIRECTIONS FOR USE 

It Is a violation of Federal Jawto use this product in a manner inconslstent with its labeling. 

ThIs malerlal requires further mixing before use ~ 

Only for formulation 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 or crack 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 or facUlty 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 coveriring treatment 

or thoroughly washed before use. Exposed foods 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) Usn for 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 product which may be labeled forthe use pattems as found listed on this label. V 

Page 2 

99 
~.~ .. -~-~---~.---

, 

Storage and Disposal ,,/ 

Do not contaminate water, food, or feed 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 or foed by storage or disposal. Improper ~~~ . disposal 01 excess posticlde, spray mixture, or rinsate Is a violation 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. H drum 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 of Warranty 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 for the 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 duly authorized 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-

104 
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, ............. -.... -

Ca) T&bi •. BocUona 160,60 IUId 15Uto throllBh 158J03 d'acribo bow to 1lh W. table to dot.orm.tna tbe aer!aJ. 'pr&)r drUt data requirement. and the tubatQ.oe to be teatod. 

[oft FR 42II8l. Oct. 24, 1984:. RtUe&!p&te4 at 53 FR U993.lot&,. to lB, AlId &mCbdod .tU rn:HlW, J'UII2l.lD03} 

, ....... -.......... _ .... _ ... (a) Tabl •• Secttona 168.60 and 158.100 throurh 158.102 d.aerl.bo how to uao thJa table to datermine tbo w1ldl1te Gel aquatic orpn(ama da.t& requirements and. the aubot&nce to be teat&tt • 

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(a) 'hblf. 8eottou 118.10 all415I.1GO throurh 151.102 dHcrlbe how to UN th!a tab). to 4ttermJno t.ba: nontarret inBOOt d&tA req111HmtDta and th6 aubataDoI to be t61ted. 

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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 of additional product 

chemistry dsta submitted to support registmtion ofBifenthrin Techniea1lnseeticidelMiticide 

(EPA File Symbol: 70506.RJ) .. These data were forwarded to TRBICHEM on July 8, 2003 

under Data Package DP291574. m requests 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 Sent for 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. I dllCUSscd 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 

• 

• 

114 
I 

., , . 

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 of events associated with 

this apprlCstion for regIstration and the one remaIning Issue about physIcal state and density I will request 

an expedited revlew(2 to 3 weeks) of the addlt/onallnformation you recently provided. If there 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 behalf of our 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 of yourself, Susan Stanton, Marion Johnson, 

Debra Edwards, and the appropriate chemists, We requesfthat a meeting be held any time the 

week of July 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 for response 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 of Bifenthrin 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 of Data) was not included. Following 

our letter to the Agency of 5/8/02 and the Agency's letter in response on 6/3/02, along with other 

meetings on the issue of the timing of filing of that form, the Agency in its letter of 8/14/02 

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 of the 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 of the I-year storage stability study. requesting that submission of the fmal report be a 

condition of registration. 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 of registration. 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 of those data requirements where the PAl is the test material and 

long term stability (which would be a condition of registration). 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 uprs technical 

(98.2% purity) was a solid (crystalline powder) while tl,e FMC technical (previously 89%, now 

94%) is a viscous 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 different method 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 of the 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 of the 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 a written explanation of a well-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 of the 

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 a delay of an 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 
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• 

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• \\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 of Analysis for Compliance with PR Notice 86·5 

Thank you for your submittal of II-JUN-03. 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 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 of June 4 and S, 2003 

Dear George: 

On behalf of our c1ien4 United Phosphorus, Inc., this letter is in response to phone 

discussions of June 4 and 5,2003, with Susan Stanton, where she requested clarification 

regarding the density of the 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 a very viscous liquid, a waxy solid, or as a crystalline 

powder (solid). depending upon the purity of the technical grade material (as identified in WHO 

specifications, Pesticide Manunllllh Eel, copies attached). As part of normal manufacturing 

processes. a lower grade, crude product is obtained and subjected to purification steps before the 

final technical grade material is obtained. The extent of the further putifieation and any 

crystallization steps will determine the appearance and density of the final technical material. 

Oily impurities remaining in the technical product contribute to the appearance of the 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 a very viscous liquid, with the waxy semi·solid form intermediate. 

CONSULTANTS TO SUCCESS'" 

Over Onc Hundred and FiftyYcars of Combined Experience Assisting Chemical, Pesticide, 

Bio·Chemica1 and Ufe Science Companies on a Wide Range of Issues, Including Regujnto,Q'"", 

Strategies, Registration, Data Support and Compensation, Quality Assurance, Study Dc1il!U 

and Scientific Matters. 
r 

• 

• 

-- ~~-~~~~~-------

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

The final appearance (fonn) of the technical material also has a direct heming upon the 

density of the technical. Liquids have a higher density than crystalline powders, with waxy 

solids intennediate between the two. 

The purity of the UPI bifenthrin technical is (nominal) 98.2%. It is a crystalline powder. 

The density of that technical material is 0.4593 gfml at 27"C, as determined in accordance with 

OECD Method 109 and CIPAC MT 3.2 "Pycnometer method" (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 a viscous 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 of these lower purity technical grade bifenthrin products is expected to he higher than 

that of the 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 of the melted and solidified material according to appropriate 

testing metllOds. The density of the 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 of the 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 of the 

product is comparable to the reported literature values when the crystalline nature of the 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 latter product, 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 
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• 

Letter to G. LaRocca. June 11,2003, page 3 

There have been significant delays in the Agency's review of this application, although 

the registrant has responded very rapidly to any questions or requests. We therefore Iequest that 

the enclosed infonnation be reviewed on a prioritized and rapid basis. 

Enclosed with this letter please find EPA Fonn 8570·1, transmittal bibliography, and 

three copies of each submitted study. 

Regards, 

Elizabeth Anne Brown 

Attachments to letter: 

1. Interim specification: WHOlISffCl41512001. TechnicalBifenthrin 

2. The Pesticide Manual, 11" Edition, 1997. Entry for Bifenthrin 

cc: United Phosphorus,lnc . 

122 
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• 

TRANSNUTTALDOCUMENT 

Submitter 

United Phosphorus, Inc. 

423 Riverview PJaza 

Trenton. NJ 08611 

Regulatory action in SUpPOrt of which 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 of Bifenthrin. 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 nBW address 

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 of Juno 4. 5. 2003 

No 

'O."'rnc~a,on must 

bosubmlnod 

"""" 

".""','" Anne Brown 

No 

COnlnlnor 

I urtU'y thut the staltm!lntS I bave made 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: WHonsrrCf4 t512001 

Specification 

nmripHon 

The material shall consist of homogeneous mixture of technical bifenthrin together 

with some re ted manufacturin . t shall be in a fonn of a 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 of the 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 of the 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 orthe container 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 of packages 

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 or rererence nwnber and date ortest 

Net weight or contenlll 

Due or manufilctun: 

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; ir swallowed.. 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 and thcircontalners. 

Irpolroning occun. call a physician. Trealmcnt is symptomatic. 

BlrenLluin b toxic 10 lIqUllt1C wildlire. A ... oid accidental contamilwlon orwattr. 

2. Methods of determlnlng chemical and physical properties 

2.1 Blfentbrln content 

2.1.1 Outlineofmethod 

This test method describes the analysis of technical 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 of octacosane is utilized by comparing 

instrument response (peak area) of the intemru standard to the relative response of 

bifentbrin, taking into account the amount of sample being analyzed. 

2.1.2 Apparatus 

Analytical Bolance. Capable of accurately 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. 

Reciprocating Shaker. 

V"lOls, Minimum 40 mL capacity, with poly-lined cap. 

Volumetric Pi petre. 

Page20fj/ 4-

126 
., ,,' 

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• 

WHOlIsrrC/4ISI200t 

Magnelic Slirrer and stir bar. 

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, or equivalent. 

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 Station Parameters: (all parameters may be modified to optimize results): 

RunTime: 

Chart Speed: 

Zero: 

2.1.5 Determlnah'oll a/response/aclor JlRF' 

S minutes 

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 of at least 1000 mL. To 

this add 700 mL ofheptnne and 175 mL of acetone, 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. of the standard solution into the gas chromatograph. 

Obtain several chromatograms and measure the peak areas of the 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 of standard 

WTis ~ Weight of internal standard 

P"" ~ Purity ofbifenthrin standard 

p. ~ Purity of intemnl standard 

Sample preparation 

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 1 J.lL portions of the 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 of internal standard peak 

= Sample weight 

Page 4 ofJlI128 
, , 

, 

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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)·(1 RS)·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::. .:!§iiD M.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 y at 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 f R 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 

CSF, Y LABEL, Y S'-~ -<U 

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-~ Product Chemistry Team ",,,-'/o:!> 

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 of 418/02, 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% of trans isomers. as listed on the label accepted 6/21/01. No 

minimum oftmns Bifenthrin isomers was included on the approved label. 

-1-

132 

'------------------------------
· . 

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• 

SUMMARY OF FINDINGS: 

I. The description of materials 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 of guideline referenS!' 

830.1620 (40CFR§158.162). 

3. The discussion on the fonnation of impurities satisfies the data requirements of guideline v 

reference 830.1670 (40CFR§ 158.167). 

4. Data requirements for oxidation-reduction, flammability, explodability ,pH, melting point, 

boiling point, density, and dissociation constant now satisfY the data requirements of guideline,,/ 

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 of the revised CSF, in agreement with" 

the study results, as required 

6. The "non-applicable" flash point given in block 9 of the CSF is now supported by study ./ 

results, as required. 

7. The chemical name for bifenthrin is now included in column 10 of the 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 of cis isomer given in ,/ 

column 14b and the maximum vruue of trans isomer given in column 14a of the 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 of the product Guideline 830.1900, (40CFRI58.190) is satisfied. 

-2-

133 
.. 

CONCLUSION: 

TRB has determined that Bifenthrin TechnicallnsecticidelMiticide is not substantially 

similar to FMC's Bifenthrin Technical, Reg. No. 279-3055, from a physical 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 of the 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 of the 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 chemistry requiremenIs are still not satisfied: 

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: 

Common Name: 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,: 128825 Jor cis ond trons mix 

Empirical fonnula: C23 H22 CI F3 02 

• Molecular Weight: 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 of materials for the starting materials were submitted. 

used to 

produce 

product 

830. Descljption 4565440J A The registrant provided detailed 

1650 of information about the synthesis of the 

production technical. Amounts of each starting 

process material and the conditions of the reaction 

were nrovided. 

830. Discussion 45654401 A The registrant provided the required 

J670 offormation information on the formation of impurities. 

of imnurities 

• 830. Preliminary 4565440J A Method validation indicates that the method 

1700 analysis is adequate for the determination of the ai. 

Analysis was conducted on 5 production 

batches of the 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 a single 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 of Samples ChemReg. registration. 

Letter 

• 

·6· 

137 
BARCODE:D285142;Reg. No. 7Q5Q6-RJ PRODUCT: Bifel1lhrill Tech.lnsecticideIMiticide 

Table 2: Ph sical and Chemical Properties for the BIFENTHRIN technical . 

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-

138 
Table 2: Ph sical and Chemical Properties for the BIFEN11fRIN technical . 

GLN Requirement MRID Stat- Result or Deficiency 

usl 

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 UVMsible absorPtion - A NA Not a liQuid at 20 C. 

830.7100 Viscosity - A NA Not 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 BIFENTHRIN technical. 

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 
Pages 141-144-*Manufacturing process information may be entitled to confidential treatment*
• 

• 

• 

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 of the 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 of the 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 of the 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 of this 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 of 500, 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 of the 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 of eye 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 

of the 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 of the 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 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 INSECTICIDE/MmCIDE 

PRECAUTIONARY STATEMENTS 

SIGNAL WORD: WARNING 

Hazards to Humans and Domestic Animals: 

May be fatal If swallowed. 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 
• 

• 

FIrst Aid: 

If swallowed: 

-can a polson control center or doctor Immediately for treatment advice. 

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

-Do not Induce vomiting unless told to by a polson control center or doctor. 

-Do not give anything to an unconscious person. 

If on skin: 

-Take off contaminated dothlng. 

-Rinse skin Immediately with plenty of water for IS-20 minutes. 

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

If Inhaled: 

-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 or doctor for 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 of supportive treabnents to maintain life 

functions; - medldne that will counteract the specific physiological effects of the 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 toxicity study (MRID 45654404), fasted (17+ hrs) 

young adult (9 week old) Wlstar rats (5 males and 5 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 & 215F died; at 79 mglkg 415M & 215F died; at 125 mglkg 515M & 3/5F 

died. All deaths were within 24 hours of dosage. Symptoms at all dose levels Included 

tremors and nasal discharge; other observations (at 79 mglkg and above) included 

abdominal breathing, nasal Irritation and piloerection. At 125 mglkg symptoms also 

Included tonic-clonic convulsions In a/l animals. Survivors wore 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 mg/kg 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 of the lungs. 13116 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. 

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 of oral 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 of feed 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 of the 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 of Toxicology, 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 of 5M 

& 5F young adult Wistar rats were dermally exposed for 24 hrs (occluded exposure) to 

either 2000 mglkg Bffenthrln technical (a white powder with 99.2% purity) mixed with an 

unspeclned amount of peanut ali "to give a slurry," or to 0.2 mL of peanut all a/ono. 

There were no mortalities. 9/10 of the 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. All rats were normal from Day 6 through Day 14. AilS males had bodywelght 

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. 

Necropsy findings (pinpOint lung hemorrhages in one ma/ej bilateral uterine hydrometra 

In one female) were considered spontaneous and unrelated to exposure to bifenthrin. 

The report states that In one preliminary range finding study mortality (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 

of 500, 1000 and 2000 mglkg ... andthe percent mortality observed was 0, 25 and 25, 

respectively." This information is considered as 6(a)(2) data, and a detailed report shOUld 

be submitted 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 died at this dose level) 

Bifenthrln technical, a white powder containing 99.2% active, Is In toxicity category III In 

terms of dermal 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 of the skin. The other group 

of ten 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 of the 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 of the 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) of the 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 of the 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:= Self Validated 

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 
Pages 155-157-*Claimed confidential by submitter*
, 

• 

• 

• 

• 

• 

TRANSMITfAL DOCUMENT 

United Phosphorus, Inc. 

740 Springdale Drive 

Suite 204 

Exto., PA 19341 

Submll!er 

United Phosphorus,lnc 

ChemReg lnlemationnl, u.c* 

2239-H Tackeus 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 Product RegislIation ("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 similar or [dunnest [n:::::~:[ "" EPA RogNo. 

Chock If this Is /J now address Product Nama 

Aaanc::v letter doled 

~ Aesubmlssion In responsel0 Agency leiter dated 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 * * * 

CASE TYPE, REGISTRATION ACTION, 166 RESB NEW PRO-OC-MIN CHG 

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 
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BACKGROUND: According to the copy of the 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 of this 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 of the 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 FIRST AID statement for eye exposure, as 

well as the precautionary statement: "Causes moderate eye irritation." The remainder 

of the 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 of the 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 DomaatIc Animal.: 

May be fatal W swallowed. HallTlfullf absorbed 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 
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F1rstAld: 

If swallowed: 

-Cali a polson control center or doctor immediately for treabnent advice. 

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

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

-Do not give anything to an unconscious person. 

If on skin: 

-Take off oonlllminased clothing. 

-Rinse skin Immedlately wfth plenty of water for 15-20 minutes. 

-Call a polson controt cenrer or doctor 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·tomouth 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 a polson 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 of Infonmatlon 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 
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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 toxicity study (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) In peanut all 

at a constant dose volume of 10 mUkg. Doses in tho main study were 0 (vehicle only), 

50, 79 and 125 mglkg. 

At 50 mglkg O/SM & 21SF died; at 79 mglkg 415M & 215F died; at 125 mglkg 5!SM & 3/SF 

died. All deaths were within 24 hours of dosage. Symptoms at all dose levels Included 

tremors and nasal discharge; other observations (at 79 mglkg and above) included 

abdominal breathing, nasal Irritation and piloerection. At 12S mglkg symptoms also 

included tonic-clonic convulsions In aI/ 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 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 of the lungs. 13116 rats found dead had pulmonary 

congestion, and It Is reported that this Is a common finding In dead animals with no 

particular pathological slgntncance. Findings In terminally sacrificed animals were 

categorized as spontaneous/accidental. 

Orel LDSO Males = 66.19 (95% C.L. of 54.48 to 77.90) mglkg 

Or.1 LDSO Fem./es = 91.89 (9S% CoL. of 26.67 to 316.63) mglkg 

Oral LDSO Combined = 74.90 (9S% C.L. of 57.29 to 97.92) mglkg 

Blfenthrln technical, a white powder containing 99.2% active Ingredient, Is In toxicity 

category II In terms of oral toxicity. 

Study Classlficat/on: Acceptable 

5 

166 
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• 

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 of feed for seventeen hours and fifteen minutes prior to dosing and then three hours 

after dosing.~ 

Results' . 

Number of Oeaths/Number Tested 

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 of the 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 
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DATA REVIEW FOR ACUTE DERMAL TOXICITY TESTING (870.1200, formerly §81-2) 

. , Product Manager: 03 

MRID No.: 45654405 

Reviewer: Byron T. Backus, Ph.D. 

CITA nON: nwart, V.K. Acute Dennal Toxicity Study of B~enthrtn Technical in Rats. JRF Study 

No. 3416. Unpublished study prepared by Department of Toxicology, 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 of 5M 

& 5F young adult Wlstar rats were dermally exposed for 24 hrs (occluded exposure) to 

either 2000 mg/kg Blfenthrin technical (a white powder 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. All rats were normal from Day 6 through Day 14. All 5 males had bodywelght 

gains In the period from Day 0 to Day 7, but all 5 females had weight losses during this 

period; 5/5 males and 415 females had bodyweight gains In the period 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 report states that In one preliminary range finding study mortality (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 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 

of 500, 1000 and 2000 mg/kg ... and the percent 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 died at this dose level) 

Blfenthrln technical, a white powder containing 99.2% actIve, Is In tOXicity category III In 

terms of dermal tOXicity, based on the dermal LD50 > 2000 mg/kg. 

7 

168 
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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 at the 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 of the 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 of the 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 of the 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. of the 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 of sao, 

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 a sensitizer 

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 I 2 2002 

SUBJECT: Product Chemistry Review 

Bifenthrin Technical InsecticideIMiticide 

EPA File Symhol: 70506-RI 

OFFlCEOF 

PREVENTION, PESTICIDES 

AND TOXIC SUBSTANCES 

EPA has completed its review of product chemistry data submitted in support of this 

application forregi.tration (MRIDf1456544-0I, 456544-02 nod 456544-(3). A copy of the 

review is enclosed for your "records. The review identifies a number of deficiencies which must 

he eddressed before this product con he registered. 'Furthermore, until edditional product 

cbemistry informntion is submitted, we cannot niake the determination whether the product is 

substantially similar to FMC's bifenthrin technical (EPA Reg. No. 279-3055). Please refer to the 

enclosed review for details regarding the product chemistry data deficiencies. 

EPA bas not yet completed its review ofth. acute toxicity data submitted/cited to support 

registration. We will edvise you of the results of our review once it is completed. 

If you bave any questions regarding this action, please contact Susan Stanton of my team 

at (703) 305-S218 • 

Enclosure 

Sincerely yours. 

;xI~/~tf George T. LaRocca 

Product Manager (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-trifl uoro-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 a termiticide 

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 a maximum of3% of trans isomers, as listed on the label accepted 6121101. 

No minimum of trans 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 of materia! used to produce the product) satisfY the data requirements of 40CFR§ 

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:D285I 42;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. A value 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 clear that 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 of bifenthrin 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 of 40CFR§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 of 40CFR§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 of the 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 and trans 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 of materials 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 of the technical. 

production Amounts of each starting material and the 

: process conditions of the reaction were orovided. 

830. Discussion 456544- A The registrant provided the required 

1670 of formation 01 infonnation on the formation of impurities. 

ofimourities 

830. Preliminary 456544- A Method validation indicates that the method 

1700 analysis 01 is adequate for the detennination of the aL 

• Analysis was conducted on 5 production 

batches of the 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 311 9/02. 

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 method should explain how cis and 

• Irans bifenthrin ;s separated and 

quantitated 

830. Submission 456544- A Samples must be provided prior to 

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 

noted after storage 01 

54 + 2 C for 14 days. 

Stability Testing at 3,6,9, 

• 12, 18, and 24 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 

noted after storage aJ 

54 + 2 Cfor 14 days. 

Corrosion Characteristics 

Testing 01 3,6, 9, 12, 18, 

and 24 months ;s required 

fOr full reJ!istration. 

·8· 

182 
.. 

GLN 

Table 2: 

Requirement 

land 

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 I Not 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 : Not a liquid at 20 C 

1 A = Acceptable; N = Not .' _C,. (see Deficiency); NA = Not applicable. 

~"'155°C" ,830: 

-9-

183 
Pages 184-187-*Claimed confidential by submitter*
Pages 188-192-*Privileged attorney-client communication*
, :no" . "1".'11 

',',\''i.d\.lJllfi «. < WA"K'N" 101:;" "A""C ~I.:.J 1'l' '6 (THUI Q ~. '2' I ::1 ._ 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 

VIA FACSIIIfiLE 

Freedom ofInfonnation Act Officer 

Freedom oflnfonnation 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- 0J.--

d),tu; \C/l02--

Re: Freedom ofTnformation Request 

Dear Sir or Madam: 

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 of bifenthrin 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 of General COWisel, or any other office, regarding EP Ats position 

on the timing of submission of offers 10 pay compcnsalioo and/or certificadol1ll 'with respect to 

citation of data . 

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. 

Wben the infonnatlon is available, pl~e call me so I can 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 

193 
f . 

i , 

194 
. -, rnO\! LA. -H"M In !(, ,. "A""" II t ..... ,~ "A'" fI tr.!J 'c -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 20 I 

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 inCOmplete for the =os given in the Agency's April 25, 2002 letter: 

"An applic:ltion is considered incomplete if any pertinent item specified,in §152.S0 has 

not beensubmitted. Pur.runnt to §l 52.50(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 of Data 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 of this 

application. n 

We reached Oul' decision aflu con:Nltation with at:tome)'5 in the Office ofGcneral 

C<JllDCiI and the R<gis1m!ioliDivisioo's ...uor management I<!atll. It was agreed'that 

applications which do not comply with the data compcnsalion regulations at the 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 =gni2e that 

you may have been .uowed in Ibc past to submit Ihesc maJeriaIs later in the review process. 

However, we do not believe 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 not reject an application 9Ulljght if it is missing information on the 

data compensation forms. The regulation does not envision thai an applicant be requin:d to 

comply with subpartEll!I!y a&r the application bas been detemlined to.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 informal ion requested above. 

If you Mve any questions teguding this action, please contact Susan StantoD of my team 

at (703) 305-5218. 

George T. LaRooca 

Product Manager (13) 

Inseclicide Branch 

Registration Division (7505C) 

196 
Pages 197-200-*Privileged attorney-client communication*
• 

• 

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 

Document Processing 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 

WEB SITES: www.chem.reg.com 

www.pesticide.net 

Re: Application for Registration of Bifenlrbin TecbnicallosecticidelMiticide. 

United Phosphorus. Inc. EPA File SymboI70506-RJ 

Agency Letters of April 25. 2002 and August 14.2002 

Dear George: 

On behalf of our clien~ United Phosphorus Inc .• enclosed please find EPA Form 8570-34 • 

Certification with Respect to Citation of Data. United Phosphorus has made the appropriate offers 

to pay compensation. 

This form is being submitted at this time in order to avoid any further delays in the 

Agency's review of this application (filed April II, 2002) while the continuing issues associated 

with the reviSed-interpretation of the timing of this certification in relation to Agency review of 

applications for registration is still being resolved. While we were reassured in the Agency letter 

of August 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 of the 

application pending such resolution or submission afthe appropriate certification. United 

Phosphorus will suffer economic hardship if there are significant delays in resolving the issues. 

CONSULTANTS TO succESS"' 

Over One Hundred and Fifty Years of Combined Experience Assisting Chemical, Pesticide, 

Bio-Chemical and Life Science Companies on a Wide Range ofIssues, Including Regulatory 

Strategies, Registration, Data Support and Compensation, Quality Assurance, Study ~1Ul 

and Scientific Matters. 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 that regulation (40 Fed. Reg. 30884, Aug I, 1984), United Phosphorus is 

allowed to submit a comp1eted CeI1ification with Respect to Citation of Data form to your office, 

and send the necessary data compensation offers to companies listeO on the data matrix, at any 

time before registration is approved. We believe that 40 FR 30884 is correct in identifying that 

the Agency will not delay the review of the application pending receipt of these 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 of application 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 of the timing of submission of such 

. 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 If this /s B new Bddrsss 

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 lor this 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 of this coIlectlon 01 Inlonnatlon. Includlng suggestlons for reducing the I ~~to: Dlroctor, QPPelnformatJon ManegomontDlvl8lon (2 t37), U.S. Environmental Protection Agency, 401 M Street, S.W., Washington, DC 

I ,of Data 

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 of compensation (the Dela- I "",,] i'lom, 

Matrlx fonn ShOuld be used for this purpose) moo "" ",.d), I da .. , 

, 

(Required If using tha cite-all method, Of when 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 of this 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 ] 

,or the Data-CBll-ln response. In addition, If tha 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$ a typo 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 of this 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 sJudy cited 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 In wrlllng the compony that submitted tho sludy and 

have offered (I) to pay componsaUon to tho oxtont required by sectlons 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 of tho 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 of my product In 

conformity with FlFRA. 

I corUfy thet the 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 I 4 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 corrected within 7S days. On June 3, 2992, in reapanse to your sulmtission 

of May 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 a new 75-day "clock" would commence following the June 3'" letter. 

The Agency is in receipt of a June 27, 2002 letter on your behalffrom Telisport 

Putsavage, Esq. with regard to those deficiencies. It is my understanding that Mr. Putsavage has 

also spoken with EPA General Counsel staff requesting thet UPI's application not be treated as 

withdmwn pending the resolution of the concerns outlined in the June 27 letter and by other 

parties regarding EPA review of incomplete applications. By this letter, I wish to confirm that 

EPA will not treat the referenced application as withdmwn pending resolution of these matters. 

If you have any questions regarding this action, please contact Susan-Stanton of my 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 Pennsylvania Avenue, NW 

Washington, DC 20460 

R.: Off .... to Pay for FoUow-on Registrants 

Dear Ms. Roberts: 

On behalf of!be Cbemical Producers and DistrIbutors Association (CPDA), I am 

writing to you concerning EPA '8 long~s~ policy of allowing lime-too" or generic 

registrants to submit a Certification with Respect to Citation of Data (EPA Form 

8570-34) "at any iater time prior to EPA's approval of!be application." 40 CFR § 152.84 

By way ofbeekground, CPj)A is a voluntary, nen-profit organization of about 90 

companies engaged in !be formuIation,' manufucturer, diatribution, and sale of some $6 

billion wortb of generic products used on food, feed, and fiber crops and in the care of 

lawns, gardens and turf. Many of our membees are involved in the development and sale 

of adjuvants and inerts used to increase !be efficacy of crop protection formulations as 

well as a variety of copper-based pesticide products. As such, EPA rules, regnlations, 

and guidelines a1fuct our member companies significantly. 

For !be pest eigbteen years 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 information required 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 of its policy, and specifically clarifies both !be timing of an applicant's 

206 
• 

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Patricia A. Roberts, Esq • Page I of5 

registration and the timing of the submission of a Certification with Respect to Citation of Data. 

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 occur before the registration is approved. EPA 

recognizes that the correspondence requirements of this subpart may take 

some time, and that an applicant may not wish to await responses 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 be baa waited 60 days after correspouding with data 

submitters. EPA sees no reason why correspondence times and Agency 

review times may not 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 

other jnfu!llll!tion pertinent 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 of the _cation. but has not received the 

IlPnlicant'. submisaions 1IJ1der this rule. the Agem;y will send the applicant 

a reiection letter. whjcb will include a 7S-dav re:monse time, after which 

the IlPPlicalion win he 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 Agency is reconsidering its poficy of the last eighteen years. We at CPDA strongly 

nrge the Agency to retain its long-standing interpretation of its regu1ation. The 

implications ofa potential policy shift are enormous. 

First, rather than expediting the registration process und using fewer Agency 

resources, the policy change would slow down the registration process, eneournge delays 

and additional review, delay entry of generic products to the marketplace and decrease 

competitinn. Such a shift would result in severe, direct negative economic impacts on 

fimners, ranchers. consumers, and pesticide consumers. 

Second, by requiring "me-too" registrants to make data compensation offers to 

pay prior to processing ofpestieidc applications, the "extra" eighty-to-ninety days will 

207 
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• 

• 

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 petition to 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 on this new interpretation of Section 40 CFR §152.&4, the 

Agency will experience an onslaught of petitions to cancel registrations previnusly 

grantad uader tbe "old" interpretation of the 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. If one 

argues that the offer to pay must be submittad with the applieation, it would completely 

undermine the clear language sad intent of the reguiation. 

If the 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 on a proposed change to the reguiation. 

We at CPDA urge the Agency to retsin its long-staading interpretation of 40 CFR 

§ 152.&4, sad dismiss other EPA efforts to uadermine sad alter the clear intent 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 of generic 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 
Patricia A. Roberts, Esq. Page 3 or5 

• 

Micbelle Knorr 

• 

• 

209 
. , 

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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 BE THE ONLY FORM OF DELIVERY OF THIS DOCUMENT 

PPFICES NEAR. WASHINGTON, D.C., AN!) IN ALBANY, NEW Yon 

210 
• 

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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 Overnight MttIL 

Patricia A. Roberts, Esq • 

Associate General Counsel for Pestidclea and Told", 

Offlee 01 General CotmseJ 

U.s. EnviIotunental Protectlon Agency 

1200 Pennsyl..rua Avenue, NW 

Washlngton, DC 2000 

July 23, 2002 

RE: Application f9r Regis1ration of Bifenthrln TeclmkalhlSecticide/Mitidde 

United Phosphorus, me., SF A File Symbo170506-RI 

Dear Ms. Roberts: 

I write to you in lin1hor regBJ;d to 1he timing of o!l'<:u to pay:data compeosation 1het I xalsedin 

my loiter 10 you ofJunt 27,2002. 'l11at letter addressed the issu. xal,ed in • letter ofJune 3, 2002 

from Mr. George LaRoeca, Product Manager 13 in the Inecticid. Br.mch of the Rogislration 

Division in the 01!lee ofPcaticide Products. to Dr. Elizabeth lIro)vn ofChemReg lAtemotional .. 

agent for United Phosphorous, Inc. ("UP!"). I had requested 1het1he Agcnoy rescind 1he notice of 

luoe 3,2002 fromMr. LoRocc&and continueto_, thoapplication;;,question, orin the abscn", 

of a rescission, that you edvise me in writing of1he1 fact and whether such refusal- is final agency 

action on this matter. To date Ih,v. received no response to my letter ormylelephone follow-II\'. 

I,uggest thaI if the Agencyrequires lin1hOf tim. 10 .-.view its position on this subject that 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 of the policy, it would "'em equitable 1het tho poliCY be applied to new .pplicatioll! 

following an announcerocnl to regulsted commnotty of the Agency's position. Underthls epproaoh, 

the application in question could continue to be processed. 

'A PROFEl9SlONAL CORPORATlON WlTB 

OmOESN!lAR "WASHINGTON', D.O., AND IN ALBA.."f)', NEW 'YORK 

211 
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01123/2002 15: 12 793-492-0066 ~IGHT & SIELATV PC 

WRIGHT &: SIELATY., P. C. 

Patricia A. 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, om olient will be lbreed to COllIiderwhot avmu08 of Ie sal rccomse arc available: It 

would be an unforIunate waste ofthefCSOmces of both oUfeli.."t and theAgencyifwe were forced 

to pUIlIUe olb ... opuo,", oimply to presetVe the ststus quo in the abooncc of. _e from the 

Agency. 

cc: 

Very truly yot11'9, 

-1~lJr~ Tellsport W. PufBavage . 

Ms. MarcIa Mulkey. DIredor. O£fke ofPesticlde Products 

Me. DebbIe Edwards, Acting ?frector. RegIstration DIVisIon 

Me. DeboxahMcCall, lNectidde Branch, ReglstmtionDivlaion 

Mr. George LaRoca, Product Manager. IngecIicide BIIl!1Ch 

Midu!Ila Knotr, Esq. Pestlcldes and Toxic Substances L<ow Of/ioe 

Mr. Jeffrey S. Prltchanl, United Phospborus Inc. 

212 
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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.IJNI1TRIJ IN N." rD~1( "ND Jt.4Al£AHIJ 

NOT ADNlTTZD III VIJ((JIHIA. . 

0.0 Steuben I'laee, S.ite 5 

Alb .. )', Now YOl'k 12~07 

By Facsimik and Overnighf Mail 

Patricia A. Roberts, Esq . 

June 27, 2002 

Associate General Counsellor Pestiddesand ToxiC! 

U.s. Environmental Proteetion Agency 

Office o/General Counsel 

1200 PennsylVllIrla Avenue, NW 

WBBhinglon, DC 2Il4.6O 

RE: Application for Registration ofBifentrhin Technical Insectidde/Mitidde, . 

United Phoaphorus, Inc., EPA File Symbo170506-RJ 

o"ar Ms. Roberts: 

I write to you in response to a letter of June 3, 2002.from Mr. George LaRocca, 

ProductManage.r 13 in the!:nse<tldde Branch of the Registration DlviBlonin the Office of 

Pesticide Products, to Dr. JlllzabethBrown ofChemRegIntemationai as agent for United 

Phoaphorous, Inc. ("UPl"), a copy ofwhichls attached. ihavea\so disalssed thismattar 

with Ms. Michelle Knorr of your office. 

In h1sJi.me 3,2002IettarMr. LaRoo:astates that the application referenced above 

is incomplete and willnotbe processed because a Ce.rtlfication wlthRespect 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 of the review of application, at which time the CertifICation 

would be submitted. Thispract!ce, whlchMr. LaRocca statesthatheis now refusing to 

follow, acconds with past Agency practice and the applicable regulations . 

.A. PltOf'ESeIONAL OORPORATIOM WITH 

On'lOJtSNEAR WASHlNGTON, D.C., A.ND IN' ALlJA."O!'. NEw YORK 

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• 

WRIGHT &; SULATY, p.C. 

Patricia A. Roberts, Esq 

June 27, 2002 

Page 2 ofS 

Mr, LaRoccaalareo that upon advice of the Office of General Counsel and WIlor 

management in the Office of Pesticide Programs: 

The regulation ,,!hich you dte as aIlowirlg submlssion.1 a later polnt (40 

CFR §152.84) has been intetprered to mean that the Agency would not 

reject an application outright if it is missing information on the data 

compensation forms. The regulation does not envision that an applicant 

oomply withaubpart E [40 CFR·§152.80 etseq.lllllbl after the application 

has been determined to be ae<:eptable for registration. Such. 

determination cannot bemada until the data oompensation requirements 

have been met (emphaslsin theorlgina1) 

This position represents a major change in the Agency's approach and 

interpretstion of regulationa applicable to the prooessJng of registration applications 

dtingthedotaofotherregistronts. Webelievelhatthischangehasbeenimplemenredin 

violation of the Federal Admlnlstrative Procedure Act, 5 U.S.C. §SS1 at seq., in thaHt 

represents a change to an e>dsting rule thai was made without benelit of public notice 

and comment. 

The Agency promulgared the 6nalrule entitled Procedures 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 on AprU 25, 1985. SJ:l: 50 Fed. Reg. 16284. 

Section 40 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. The Agency willnot approve any application 

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). 

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WRIGHT " $IELATY~ P.c. 

Patricia A. 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 of the application" to 

mean at the time the applicationls filed. and thetdespite our ""Perience to the oonl7ary. 

has tonSistently done so. Thls position directly contradicts both the ""Press text of 40 

C.P.R. §152.84 and the Agency'. hlstoric iIlterpretation of the rule. . 

To argue that the phrase "at any later time» can be applied to mean that the 

cerlifi.cationmustacoompany the application renders the permissive phrase "should be 

submilied with the application" m.aningl .... Thls position not only defies standard 

reguiatol)'Interpretation principles. bu.t ""Pressly contravenestheposition taken by 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 oullts approach to the timing of an applicant's registration application 

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 

determIne whether themalerials required 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, 

but must og;urbelore there&!Blranonls IIWroved. BP A recognizes thetthe 

correspondence requirements of thls subpart may take some time, and that 

an applicant may not wish to await responses 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. BP A .... no 

reason why correspondence times and Agency review tim .. may not run 

concurrently. Section 152.84 therefore provides that ap.plicanlli miIy submit 

materials required by this subpart Mon.v timebefore~tlon Is smnted. 

The AfI!ID!;Y will not delay the review of other InIonn_tion pertinent to the 

APPlicatioxl pendlnS wceipt of lim i1Dd certification stalemenlli. but will not 

~ the feils!ration un!llfuey are recejygd. 

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.. 

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 late in thaAgency'B WIiew, theregistr.tioncould be 

delayed while tha appllcantcorreCl!! the ptobIem.l:ftha agencycoml'Jetea 

!Is ttview of tha i\I'Ifllglion. but has not J1lQ!lyed tb!l WpliCllllt'. 

submip!oN Jl!)dl!t t:bls rule. the Aeon£)' willftend tha i\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 

application will be required if tha applicant wants topursue registrationat 

some later date. 491'ad. Register ~ at 30897. (emphasis added) 

Given the express lennoftherule andEPA'.foanally-expreosedlnterpxetationof 

it thalmplementatlon oflhe contwyposition expressed byMr. LaRocca and Ms. Knorr 

would requirepromulgatlon ofanamendmentoftharuleptn'8uant to the procedutes of 

the Adminisirative procedure Act 

TheAgency'spositionisnolonlyinconlravention.oftheruIebutID-advisedona 

policybasfs. Byrequiringdata-<:iterstomokeofferstopaypriortothaprocessingoftha 

applicatioxotheAgencywillinvirenumerouspetilionstocanoelwhllesuchapplications 

arebeingprocessed,lharebyburdenlngboth tha Agency and applicantswllh additional 

delays in processing applications. In addition, if the Agency insists upon pursuing its 

new intelpretation, counaellor several data submitters have 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 and basad upon untimely offers to pay. 

r request that tha Agencyrescind thanotice of June 3, 2002fromMr. I.aRocca and 

continue to process tha application inquestion. Uponcampletionoftha review; UP! will 

providelhenecessarycertificationconfirmingthatanofiertop.ylhedatasubmitter(s) 

has been made. . 

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 

If the Agency refusEs to rescind the June a-inotice, pl~inunedia~y advise".. 

in writing of that fact and whether such refusal Is fina1.geney aclion on this matter. In 

such circw:nstances, UPI resexves the right to .. ek an injw)ctlon in federal coUrt to . 

compel EPA to comply with the proceclura1requirementa set forth in the 19B4Federal 

Register. 

Very tru1y yours, 

~01t.v. fuf~~ . Te!isport W. Pulsavage 

Ms. Marda Mulkey, Director. O£f!ce ofPestidde Products 

Ms. o.bbie Edwards, Acting Director, RegIstration Dlvlslon 

Ms. Deborah ~ InsecIid.de Bnnch; RegIstration D!vlslon 

Mr. George I.aRocca. Product Manager, 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 LA W 

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 

NOT ADMITTED IN Y'JItGINIA 

One Steuben Place, Suite 5 

Albany, New York 12207 

By Facsimile.and Overnight Mail 

Patricia A. Roberts, Esq. 

June 27, 2002 

Associate General Counsel for Pesticides and Toxies 

US. Environmental Protection Agency 

Office of General Counsel 

1200 Pennsylvania Avenue, NW 

Washington. DC 20460 

••• • • • •• 

• 

· •• .. • •••• 

• 

•••• • • •••• 

., 

.. . . · .. RE: Application for Registration of Bifentrhin Technical InsecticidelMiticide, 

United Phosphorus, Inc., EPA I'ile Symbol 70506-Rf . 

Dear Ms. Roberts: 

• ••••• • •• • • 

• ••••• • .. • 

• •••• • • ••••• 

I write to you In response to a letter of Tune 3, 2002 from Mrc George LaRocca, 

Product Manager 13 in the Insecticide Branch of the Registration Divisionin the Office of 

Pesticide Products, to Dr. Elizabeth Brown of ChemReg Internatibnal as agent for United 

Phosphorous, Inc. ("UPI"), a copy of which is attached. I have also discussed this matter 

with Ms. Michelle Knorr of your office. 

In his Tune 3, 2002 letter Mr. LaRocca states that the application referenced above 

is incomplete and will not be processed because a Certification with Respect to Otation 

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 of the review of application, at which time the Certification 

would be submitted. This practice, which Mr. LaRocca states that he is now refusing to 

follow, accords with past Agency 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 that upon advice of the Office of General Counsel and senior 

management in the Office of Pesticide Programs: 

The reguJation which you cite as allowing submission at a later point (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 subpart E [40 CFR §152.80 et seq.] ~ after the application 

has been determined to be acceptable for registration. Such a 

determination caru19t be made until the data compensation rf7quirements 

have been met. (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 

citing the data of otherregistrants. We believe that this change has been implemented in 

violation of the Federal Adininistrative Procedure Act, 5 U.S.c. §551 et seq., in that it 

represents a change to an existing rule that was made without benefit of public notice 

and comment. 

The Agency promulgated the final rule entitled Procedures to Ensure Protection 

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 of the application. The Agency will not approve any application 

until it determines either that the application is not subject to these 

requirements or that 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 applicationis filed, and that despite our experience to the contrary, 

has consistently done so. Thls position directly contradicts both the express text of 40 

C.F.R. §152.84 and the Agency's historic interpretation of the rule. 

To argue that the phrase "at any later time" can be applied to mean that the 

certification must accompany the .application renders the permissive phrase" should be 

submitted with the application" meaningless. This pOSition not only defies standard 

regulatory interpretation principles, but expressly contravenes the position taken by the 

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 timing of an 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 

determine whether the materials requIred to be submitted, including those 

that are requIred by this Subpart E, comply with the requIrements of the 

Act. This part of the review need not take place before the Agerl!;ybegins to 

review the application for compliance with other statutory requirements • 

but must occurbefore the registration is iij>proved. EPA recognizes that the 

correspondence requIrements of this subpart may take some time, and that 

an applicant may not wish to await responses 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 reqyired by this subpart at any time before registration is &ranted. 

The Agency Will not delay the review of other information pertinent to the 

application pending receipt of lists and certification statements, but will 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 awarel however~ that if deficiencies are found in 

materials submitted late in the Agency's review, the registration could be 

delayed while the applicant corrects the problem. If the agency ccmpletes 

its review af the a:pplicatiQn, but has not received the apl'lic.m'§ 

submissions under this rule, the Agency will send the applicant a rejection 

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 will be required if the applicant wants to pursue registration at 

some later date. 49 Fed. Register 30884, at 30897. (emphasis added) 

Given the express tenn of the rule and EPA's fonnally-expressed interpretation of 

it, the implementation of the contrary position expressed by Mr. LaRocca and Ms.Knorr 

would require promulgation of an amendment of the rule pursuantto the procedures of 

the Administrative Procedure Act. 

The Agency's position is not only in contravention of the rule but ill-advised on a 

policy basis. By requiring data-dters to make offeFS to pay prior to the processing of the 

application, the Agency will<invite numerous petitions to cancel while such applications 

are being processed, thereby burdening both the Agency and applicants with additional 

delays in processing applications. In addition, if the Agency insists upon pursuing its 

new interpretation, 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. 

] request that the Agency rescind the notice o£June 3, 2002 from Mr. LaRocca and 

continue to process the application in question. Upon completion of the review, UP] will 

provide the necessary certification confirming that an offer to pay the data submitter(s) 

has been made. 

221 
.' 

f 

.. 

WRIGHT a SIELATY, P.C. 

Patricia A. Roberts, Esq 

June 27, 2002 

PageS ofS 

If the Agency refuses to rescind theJune 3'" notice, please immediately advise me 

in writing of that fact and whether such refusal is final agency action on this matter. In 

such circumstances, UPI reserves the right to seek an injunction in federal court to 

compel EPA to comply with the procedural requirements set forth in the 1984 Federal 

Register. 

liZ:;;s, 4( fuf~J!k- Te1isport W. Puts.vage 

cc Ms. Marcia Mulkey, Director, Office 01 Pesticide Products 

Ms. Debbie Edwards, Acting Director, Registration Division 

Ms. Deborah McCall, Insecticide Branch, Registration Division 

Mr. George LaRocca, Product Manager, Insecticide Branch 

Michelle Knorr, Esq., Pesticides and Toxic Substances Law Office 

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 

Your Resubmission Dated Msy 8, 2002 

OFFICE OF 

PREVENTION. peSTICIDES 

AND TOXIC SUBSTANCes 

EPA hss reconsideted its position with respect to the subject application nnd determined 

thattheapplicationlsincompletetOrlliC-'gI~IliC~'sAPri12S.20021etter: ,~>l" . '*"/ . . 

"An appUcstion is consideted incomplete if any pertinent item specified in § 152.50 hss 

not been submitted. Pursuant to §152.50(f) an appUcant must submit msterials to 

demonstrate thathehss complied with 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 of Data (EPA Form 857()"34) 

indicating the Method of Data Support you are using. You must also submit a Ust of 

companies sent offers of compensation for data you are citiog in support ofthls 

appUcation. " 

We reached our decision after consnItation with attorneys in the Office of General 

Council nnd the Registration Division's senior management team. It was 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 complete the appUcstion have been submitted. We recognize that 

you may have been allowed in the past to submit these 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 • later point (40 CFR §152.M) hss been interpreted to 

mean that the Agency would not ~ect an applicstion outright if it is missing information on the 

data compensation forms. The regu\ation does not envision that an applicant be required to 

comply with subpart E lIllIx after the application hss been determined to be acceptable for 

registration. Such a determination cannot be 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 of registnUion and will not begin review ofthase 

materials wrtil you submit the infonnation requested above. 

If you have any questions regarding this action, please contact Susan StanIOn ofmy team 

at (703) 305-5218. 

~T.LaRocca 

PrOduct MaMger (13) 

Insecticide Branch 

RegistnUion Division (7505C) 

224 
Pages 225-230-*Privileged attorney-client communication*
• 

• 

• 

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 of Bifentrhin Technical InsecticideIMiticide, 

United Phosphorus, Inc. EPA File Symbol 70506-RI 

Agency Letter of April 25, 2002 

Dear George: 

• •• • .. • . 

• 

• 

• ... • • 

• 

• ••• 

... .. . • • • • 

In your letter of April 25, 2002 (copy enclosed), you stated that the Agency will not 

continue processing the application for registration of the above product if EPA Form 8570~34 and 

associated materials were not submitted within 75 days of the date of receipt of your 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 of Data 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 of April 25, 2002, is unclear as to whether the Agency has reached a decision 

on approval of the application for registration. Please confirm in writing that your letter of April 

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 of the application. 

CONSULTANTS TO SUCCESS"'i 

Over One Hundred and Fifty Years of Combined Experience Assisting Chemical, Pesticide, 

Bio~Chemical and Life Science Companies on a Wide Range of Issues, Jrt.cluding Regulatory 

Strategies, Registration, Data Support and Compensation, Quality Assurance, Study D~~ 

and Scientific Matters. L..j ., 
• •• • • · .. 

• • • ... • 0 

• 

•••• 

... • ... 

- " • • 

• ••• • •• • • ( .. ~~ 

• • • • 

• • • • • • • • 

, . • 

• 

• 

232 *Internal deliberative information*
, 

• 

• 

George LaRocca 

May 8, 2002, page 2 

I look 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 of April 25, 2002 (George LaRocca) 

2. ChernRegInternational, LLC letter of April II, 2002, on behalf of United 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 

ANa TOXIC SUBSTANCES 

United Phosphorus, Inc. 

elo Ms. Elizabeth A. Brown, Ph.D. 

ChemReg International, LLC 

1990 Old Bridge Rond, Suite 20 I 

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 § 152.1 04, 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 of the application can be completed. If such deficiencies cannot be corrected within 

75 days, you must notify the Agency within those 75 days of the 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 a new 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"t he has complied with FIFRA see. 3(c)(I)(D) and subpart E of part 152 

(Procedures to Ensure Protection of Data Submittersl Rights), Therefore, you must 

submit a completed Certification with Respect to Citation of Data (EPA Form 8570.34) 

indieating the Method of Data Support you are using. You must also submit a list of 

companies sent offers of compensation for data you are citing in support of this 

application. 

234 
• 

• 

-2-

lfyou have any questions regarding this action, please contact Susan Stanton of my 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 behnif of our client, United Phosphorus, Inc. (UPI), we are submitting an application 

for a "me-too" registration of Bifenthrin 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 of each submitted study 

Application form 8570-1 

Five (5) copies of the 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 of this 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 One Hundred and Fifty Years of Combined ExperienceAssisting Chemical, Pesticide, 

BiowChemical and Life Science Companies on a Wide Range of Issues, Including Reg(i)A4itY 

Strategies, Registration, Data Support and Compensation, Quality Assurance, Study"Dfr'mjfn 
• 

• 

Letter to G. LaRocca. April 8. 2002. page 2 

certification and general offer to pay at any time before registration is approved. The 

Agency will not delay the review of the application pending receipt of these statements. but 

will not approve the application until they are received and determined to be in 

compliance. 

49 Fed. Reg. 30884 (Aug. 1. 1984). Final Rule: Pesticide Programs: Pesticide 

Registration and Classification Procedures,' Application Procedures To Ensure Protection 

of Data Submitters' Rights. 

As sllch, we will submit a completed Certification with Respect to Citation of Data 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 data matrix is 

accepmble and that EPA has decided to approve the enclosed application . 

UPI's technical grede bifenthrin is of a higher purity that thnt of the substantially similar 

EPA Reg. No. 279-3055. However. the enclosed studies identify that the acute oral and dennal 

toxicity are comparable to that of the ~gistered product Since it is known and well-documented 

for pyrethroids that the isomer ratio is of greater importance than slight differences in purity and 

since upr s product has a comparable isomeric ratio to that of the registered product and does not 

contain impurities of toxicological 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 at the Ageney is applicable regardless of the purity of the technical 

grede material. These dam are OPPTS 830.7050 (UVNisible Absorption). OPPTS 830.7220 

(Melting Point). OPPTS 830.7950 (Vapor pressure). OPPTS 830.7370 (Dissociation Constant). 

OPPTS 830.7550 (OctanoVwaterpartition coefficient). Other characteristics. such as solubility. 

are not appreciably affected by the minor differences in the purity of the 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 of Bifenthrin 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 a waiver 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 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 not hesitate 

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 § 152.1 04, 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 of the application can be completed. [f such deficiencies cannot be corrected within 

75 days, you must notifY the Agency within those 75 days of the date you expect to complete the 

application. If, after 75 days you do not reapond, ot you 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 if it has been withdrawn by the applicant. Any 

subsequent submission relnting to the application must be submitted as a new application. 

1. An application is considered incomplete if any pertinent item 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 subpart E ofpatt 152 

(Procedures to Ensure Protection of Data Submitters' Rights). Therefore, you must 

submit a completed Certification with Reapect to Citation of Data (EPA Form 8570-34) 

indicating the Method of Data Support you are using. You must also submit a list of 

companies sent offers of compensation for data you are citing in support of this 

application. 

239 
• 

• 

• 

-2-

If you have any questions regarding this action. please contact Susan Stanton of my team 

at (703) 305-5218. 

Sincerely yours, 

George 

/~/~L T. LaRocca 7 - Product Manager (I3) 

Insecticide Branch 

Registration Division (7S0SC) 

240 
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• 

• 

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 086 II 

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 A NEW REGISTRATION 

DEAR REGISTRANT: 

OFfiCE OF 

PREVENTION. PESTICIO€SANO 

TOXIC SUBSTANCES 

The Office of Pesticides 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 of receipt 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, Inc 

ChemReg 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 of which this packalZe is submit!ed 

New Product Registralion ~"Me-Too") 

(Bifenthrin Technical InsecticideIMilicide 10506-x) 

Spbmltted Studl"" 

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 Confidential Business 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 

Document Processing 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 behalf of our clien~ United Phosphorus. Inc. (UP!), we are submitting an application 

for a "me-too" registration of Bifenthrin 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 of each submined study 

Application form 8570-1 

Five (5) copies of the 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 of this 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 One Hundred and Fifty Years of Combined Experience Assisting Chemical, Pesticide, 

Bio-Chemical and Life Science Companies on a Wide Range of Issues, Including Regulatory 

Strategies, Registration, Data Support and Compensation, Quality Assurance, Study ~ 

and Scientific Matters. 
• 

• 

Letter to G. LaRocca. April 8.2002. page 2 

certification and general offer to pay at any time before registration is approved. The 

Agency will not delay the review of the application pending receipt of these 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 of Data 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 of a higher purity that that of the substantially simliar 

EPA Reg. No. 279·3055. However. the enclosed studies identify that the acute oral and dermal 

toxicity are comparable to that of the registered product' Since it is known and wen~documented 

for pyrethroids that the isomer ratio is of greater importance than slight differences in purity and 

since upr s product bas a comparable isomeric rariq to that of the registered product and does not 

contain impurities of toxicological 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 of the purity of the 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 (Octanolfwater partition coefficient). Other characteristics. such as solubility • 

are not appreciably affected by the minor differences in the purity of the 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 of Bifenthrin 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 a waiver 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 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 

ELIZABETH 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 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 behalf of our client, United Phosphorus, Inc. (UPI). we are submitting an application 

for a "me~too" registration of Bifenthrin 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 of each submitted study 

Application form 8570-1 

Five (5) copies of the proposed label 

Data matrix forms for EPA and public use (Form 8570-35) 

Please note that we are relying upon the selective ci te-all method to satisfy data 

requirements that have not been satisfied by data submitted by UP!. 

As expressly permilled under 40 CFR § 152.84 and various FedernI Register notices. UPI 

will submit compensation offers to companies listed on EPA's Dam Submitters Ust as of this 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 penni ned to submit his 

CONSULTANTS TO SUCCESS''' 

Over One Hundred and Fifty Years of Combined Experience Assisting Chemical, Pesticide, 

Bfo-Chemical and Life Science Companies on a Wide: Range of Issues, Including Regulatory 

Strategies. Registration, Data Support and Compensation, Quality Assurance, Study Design 

and Scientific Matters. 247 
.I 

• 

I 

i • 

Lener to G.l.aRocca, April 8, 2002, page 2 

certification and general offer to pay at any time before registration is approved. The 

Agency will not delay the review of the application pending receipt of these statements, but 

will not approve the appIication until they are received and detemlined to be in 

compliance. 

49 Fed. Reg. 30884 (Aug. I, 1984), Final Rule: 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 of Data 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 of a higher purity that that of the substantially similar 

EPA Reg. No. 279-3055. However, the enclosed studies identify that the acute oral and dennaJ 

toxicity are comparable to that of the registered product Since it is known and well-documented 

for pyrethroids that the isomer ratio is of greater imponance than slight differences in purity and 

since UPl's product has a comparable isomeric ratio to that of the registered product and does not 

contain impurities of toxicological 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 of the purity of the 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 of the 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 of Bifenthrin 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 a waiver 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 
• 

• 

TRANSMITTAL DOCUMENT 

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.ConMemiol Business lnfonnarion. 

Joshi. C. Nov 12, 200 1. 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 

250 
UnIted State. oEPA Environmental protection Agency Amendment 

Other 

~ NOM 0 Restrlc!od 

279-3055 

Check If fh/$ Is 8 new address 

EPA Rog No. 

Product Nama 8!1eolhrln Techn!ca! !nsectk:!deIM!tIc!do 

o Rosubmlss!on In response 10 Agency !etler da!od ___ _ 

NoHficatiofl- Exp!a!n be/ow 

8;;;;;;,,., Anne Brown 

Aoancv !atter datad 

~ "Me Too' App!lcation 

~ Othol' - Exp!a!n be!ow 

Vos 

No 

Packagowgt 

rnuy be punislmble by nUl' 

EII,ab,,"' Anno Brown •• 

•••• • •••• 

(Stalilpod) 

• • •••••• • 

• • •••••• • 

• 

• ••• • 

• •• 

251 
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Unitod staiD :' 

En\tlronmen~IProtaCltl,on·Agency. - wa.w.iti DC 20410 " 

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'''''' ....... WIll 

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Registration o C- Amendment rI....: Other· ',. 

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I certify thet tho atetamont. I havo mod. on 

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_ ore tru.~ ~Cpratt and c-~et •• 

punian.wli bV fino' Or 1mprliQ~ Of ~ . . -" 

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'"PAPERWORKREDUCnOI'lACT NonCE and INSTRUCTIONS 

.~~r$~~~~~~~'~~f~'~O~"~U;';"if'~',~ .. ~-~' 8tJon. for now roQlattotion. and u .. Nlreglltratlon. amendnant. reaubmiuion, to appIIoatlon; - " In o~.r to proce .. In applicatIon' for 8 now ragirJtflrtlon ,ubmlttod on W_ form. tho 

to cftatIllh 4f Pata (EPA Form 8&71).29i. ilf not llXomptod by 40 eM 162.rl1 (hI (41): 

of Formula IEPA'Form 8570-41: --

3. Fotmufoto,.. Ex.mption Statemont (EPA Form BS7o-.:21J: 

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1'~~~~~!~~~~~:""~:uJd x 11 1Irst be S\tbmitt~ In Jhe form o,f dr.'t IlIbal. ,with IIlIllPpn~ona fO( flOw rfJg!ut.atJo/'l. S,uoh dr,ftJabal. may bel Inch paper lot IlUbmlaaton Of" mockup of tho propond labeI:1f prepaml for mockup. It should, be 

itot'ogt In 'an 8.6 x 111neh m •• Mockup Ialal. slgnifiClintfy sma/lor than •• 5 x 11 Inches ,houkl be mtKInted on 8.5 

~rt ot th1J eppllcatlon mult be submitted In .ccordrmco with PR Notice 86-5. 

,~~~~~~~~~~~PI"'. you tto reod .ubmittIng tho InitMrtion'liatod thl. application. bolow For IIIPpUeatlofll:lUbmllUd bolOi. completing W, Iffoonneotlon applioatlon. Ant wfth determine' NOw R,fgtItratlon tho typO 1CtIonI. 0'-~Itr.tlon Soctiorni 

by tho IPPIicGnt. For appHcationllUbmltted In oohlloctl.on with emended rorogiauetlon .cUOM, roeubmlaalonll, 

Sections I. II, end IV muri b. oomploted bythti' appifoent. 

action fOf whioh you me IUbmitting tN. form. 

IJlEl::m:mJ: Thio Hotion mult bo completed ... applloabl •• for ell roglotretlon .c1ions. 

Cotnp;IfIV/PfoduCl,~' m.ort Your Company Number, If one has boen .. algood by EPA. Thli numbot moy have boon e .. lgnod to you' as • 

bufc ntgIl'ttent. I,dtltributor, or lIS an"Ofleb!lotimont., 'ff,ywr product 'I rogt"lred. lnun tho Product Number. 

8'A 

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PtOtNot MarniQot. If known. fill in tM riaifit;1I{vfPM 'number 9f #lv EPA Product MM.r, 

CtUaiffeatiol1· Speclfy,the_ p(1)pOIO;!i oItm4.fI~on QfJhi' produot. Produet Namo ·,Entor the complete produ,a-t fIamG- of thle peotickl._ alit wUI.-ppear on tho I_ebo!. Theo namct mud be_'DfHJOIffo to thle product only. 

D~ &f name. if 'not pelnllitad ian)ong producu: pf thO .am. company. Do not InCfud" any brand n8rno or ~any line duigMtione-; Ham. 

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~AddreH- of'~ '-""'-'Nime i1f me ffnn Of'p6tS9n' and addio" _ihoWn 'In yoUr applicatlon Ia: tho-poroon or,firm to whom thI 

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rnattMt: 'An aq)pti_ not fOOIdlfifiiti tho-United Stat .. muoi''tia.,. en authorized 800nt rukUng In tho Unltod stItH· to eot for them In aU 

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that h'afmIlor Of Ida;n~~'to othW pftttcido prodOOh. ttlat-m __ oumnUy,rag!lterod with tho Ei'A. In ordar for your ",::~,~:~,~~~. :~':~:~ ~tod ... viaw. you ri1uIt pro\lld. us wi~ tho EPA neglatrlltion Numb., and product name of the product you boIIe'v.ll clmllar to 

yoUr product., The product muat be lir'nUM Of idonticalln both formuJadon and Jabefod uuc . 

. t~~~~· Thli _don mutt bel ~etad for eft appII'catioM wbmItted to cntnd 1M reglltrlltion only of a ourrandv regiltored product for I r.~ In rH9j)fU1e to an Agorwy lettar, for notlfloatJOM to the Agency. for tho ~Ialon of final printed labdng. for 

end fOf any othcw etlan that partfllM to. !Pfeifle EPA·t!Hl!fttmd pmduct. Th10 .. edon Ia: D9l12u. unci for. now appfioatlon for 

aub)6ct of • .wmlnion wCbKk tho jIf)PIloebl:e block and proWla tho Agency lonor dati if appropriot.. Provide. Mof explanation 01 the purpollbll 

for tho oubmiuion,lUch .. "me addition of. ilie. peli or crop (lJPocify)~; "amend thI Confldontlal SUitomant of Formula by ..... : "rerogiltratlon 

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be packaged In the Indicated peckaging typos. 

be malkotod. 

for your produat. 

oontainefl for your product. 

of the un dlrootlON: for your produot. 

to producI·llldIcat.d lho med\od product 1tbaI1I ~hId to retail COf\UIlner. 

I:~~~~~!:::.~t~:: -Thil S.otlon mult bo ""'Plated for ell opplicatJOM for RlglluetJon aotionl. I •••• new prDdu-cti ragiotretion. , "ma-too." reragiltl'lltlon. fltc. 
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~"fpAPEilWORK REOVCTION ACT NOTICE apdlNSTRUCTIONS '''.' 

burdon forthll 

~~f1~~~~~~~~~~~~g~"'~i'oW~·l~~:'.;'; ... :w;= ....~retlon, end UIO nregiltrotlon. III'Rtndmont. reOubinltlllon, to appfJt4ItIons !,,~,' In o~er to ~rooe".e ~n eppIiClltio,n for a now regirrtralIo~~eu!mI{ttod on_,thie, f~. ~. 

-- ' ': "". ", 

... ~; [II not exompted by 40 eFR 152.rl1 (b) 1411; 

i' :L' 

3. 

4. , labeling;. 

5. ThrM ~ of any'dat8lUbmfttadl;--

6. Authoriletlon 1fl1., who,.. appl~;' 

.~ J~ ~~,!-"",Whe" ~~~. ~,,' "',: ., .. ,';::; ,>, 

~r;~~ 

• ootlOn mu.t ho ,1-, applicable, fer tilt regietnltion -.-otlone • ..... , ..... '. 1. 

8. 

1. 

2. 

3. 

4. 

, 

Location of u.. 

6. MantMt' In whlch 

1·5. Selr .. lqllanatory. 

6. EPA u.. only. 

rue nu~r may how lain uaigMd to you at II 

tho Product Numblr. 

M,pnogoi:-'-

,only of. 

PrO'lido 

~ 'to this Wlduet only. -, line deol~M. 

..., 

to whOm the " 

them In nQlitretion 

oH' , • 

of the pul'pootl,l 
;;;,.'" J,~ Form, dOMSI 

burden estimate or any other aspect of this collection of information. including suggestions for reducing: lbe burden to: Director. OPPElnfonnation Management Division (2137). 

U,S. Environmental Pro!:ection nc .401 M Street, S.W .. Washi on DC 20460. Do not send lbe form to this address. 

DATAMATRlX 

102 1.20 102 I EPA __ Reg No.1 File Symbol I Page I of3 . ____ g No.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) 

e Study Name 

"Cl" .. ::m"l;::cal::or.1 --

r analysis 

10 of limits 

Anal tical method 

Color 

Ph si, 

Odor 

uvr 

12 (830.7000) I oH 

~ process 

~.~ 

. -.. -

[MRIDI 

I CITE 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 

I Pay 

I Pay 

i

l'a 

own 

own 

p, 

Note 

Signalure 

~ .... <bVt:t.v... ~ 

Name and Title I Date 

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 Copy 
hours 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'NlTED STATES 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 . 

..;"",." .;;;. fi'ft'} 

I,ei J)/';' tJA/tr .-~:" .. 'M./...,......-,; ... ~-. 'u_ :;.;; c,~ ,.,..,~. 

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 Paper version. 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 of information is estimated to a ... erage 0.25 boun; per response 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 fonns. Send comments regarding the 

burden estimate or any other aspect of this collection of information. including suggcstiOfl'> for reducing the burden to: Director, OPPE Information Management Division (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 

~te...<J.. I<t.,,~ 

• • • ••• • • • • ••• •• • ..... • ••• •• • 

•••••• • • • • • • • • •• •• • • 

DATAMATRlX 

EPA Reg No} file Symbol 

705Q6. 

Product: Bifenthrin Technical 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 of the Ag Re-entry task Own 

force; UPI is a member of lhe Outdoor 

Residential Task Force 

UPI is a member of the Ag Re-entry task Own 

rorce: UPI is a member of the Outdoor 

Residential Task Force 

UPI is a member of the Spray Drift Task 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 

CD 

Signmure 

~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 Paper version. Public File Copy 
'. 

hours per response for reregistration and special 

burden estimate or any other ao;oect of this collection 

Signature 

~j"""~dML. ~,J 

• NITEDSTATI!S ENVIRONMENTAL .ECI'lON AGENCY 

401 MStreet,S.WY 

time necessary forms. Send comments 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 Paper versions 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, 

or any other tt'q)eCt of this collection of information,. • 

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 
Pages 262-265-*Confidential Statement of Formula may be entitled to confidential treatment*
.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 of Pesticide Progmms (7504C) 

U.S. Environmental Protections Agency 

1801 Ben Street 

Arlington. VA 22202 

November 2. 2004 

Re: Bifenthrin Te<:hnicallnsecticide, EPA Reg. No. 10506--18 

Submission of Production Infonnation 

Dear Mr. LaRocca: 

In its Notice of Pesticide 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 of Sept. 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 of PRJ A. 

Please contact me If you have any questions. 

Very truly yours. 

Rebecca A. Clemmer 

rnlemmer@upi~uS!l.com 

••••• • •• • • 

••••• • • •• ... ~. 

• • ••••• 

· , •••••• • 

• • •••••• 

• 

• 

••• • • •••• 

• • • •• •• •• 

• ••• • • • ••• 

•••• • •••• 

266 

*Commercial/financial information may be entitled to confidential treatment*