# EPA Registration Jacket 87650‐1

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Date: uS / 2£!: / IV 

# To:

____**-'-f~'---i**',---,--,I 

# u"----- ___ , 

# Regulatory Manager From: Information Services Branch,ITRMD Yourreceipt ofthis data submission is not an indicationthatMRIDs for the enclosed studies have beenpostedto OPPIN. 

# "k "

# " We expect that it will be approximately 5 days 

# ---from the above date before the study-level data is available in OPPIN. 

# Ifyouhave any questions about this process, please contact TeresaDowns (305-5363).

This is a: 

# ;n fully accepted submission D

# partially accepted submission D 

# rejected submission

# '" IFee for Servicel 

# (87 2518-

This package includes the following

@ 

# New Registration °Amendment for Division 

# OAD OBPPD @RD 

# lI 

# I

, 0Studies? o 

# Fee Waiver?

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## 0 

# volpay 

# % Reduction: Risk Mgr. I 

# Receipt No. EPA File Symbol/Reg. No. Pin-Punch Date: 

# s-I 875251

# ~I=== . 87650-R 

# I 5/24/2010 

# D This item is NOT subject to FFS action. Action Code: 

# II ParenUChild Decisions: 

# I 

# II ! 

# Requested: (_

# '31 D '

# I Granted: 

# t i?"Q) Amount Due: 

# $ 

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# Inert Clea;ed for Intended Use Reviewer: 

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# Uncleared Inert in Product Date: 

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## Ilg'1iSTro.f't I'mcallingregardingyoursubmission in

## supportof 

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# Bp05Ylil TrohOiCaJ., Wehavefoundthefollowing deficiencies regarding: PRNotice 86.5: Yes orNo Volume/StudyTitle: Volume/StudyTitle: Volume/StudyTitle:
Additionalvolumes continuedonbackofpage: Yes orNo ApplicationPackage: Yes orNo 

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Thesedeficiencies havebeenapprovedbyEPA. Thecorrectionscanbefaxedto 703-305-50601Attn:

_______ . Second CaIIJEmaiI: I{wedonotreceivethe'correctionsby , wewill

## process yoursubmission, accordingIy. Pleasedirectallfuture calls and correspondencetothe appropriateEPARiskManager.

### Ms. Bjornson,EPA Submission: Fipronil Technical 

### Jennifer Brandon

### ~o hbjornson Cc: Sree Nair**.--~~** 06/07/201010:01 AM



### This is a follow up email to my correspondence sent 

### on06/01, with regards to your application for theproduct FipronilTechnical I have also made several attempts to reach you at**202-828~8945.** 

### Please be aware that this is a time sensitiveprocess. Please send the corrections at your earliest convenience, 

### Inthe DataMatrix (EPA Form: 8570-35), under cite all data, please specifywhich guidelines are being cited. Alsq under submitter, please add the companies to whom an offerto payhasbeenmade. For the section "rvIRID number" you can either cite the MRID from the specific companies orwrite cite-all You can send these forms eitherbyfax**t0703-305~5060/** 

### ATTN: JenniferBrandon or email them to brandon.jennifer@&J'a.gov. Ifyouhave any questions orrequire additional infonnatio.p.please do nothesitate to contactme. Jennifer Brandon Data Analyst (EPA Contractor) 2777 S. Crystal Drive Arlington, VA 22202 Ph: 703·305-0074 Fax:**703-305~5060** 

### Email: brandon.jennifer@epa.gov

### EPA Submission: Fipronil Technical 

### Jennifer Brandon

### ~o hbjornson Cc: Sree Nair**.~_C** 

### Ms. Bjornson, 06/01/201003:40 PM



### This is a follow- up email with regard to your submission in support ofthe registration ofthe product Fipronil Technical(EPARegistration Number: 87650-NEW). We have found the following deficiencies regarding your submission IntheData Matrix (EPAForm: 8570-35), under cite all data, please specify which guidelines are being cited. Alsq under submitter, please add the companies to whom an offerto payhas been made. Forthe section 

### "MRlD number" you can either cite the MRID from the specific companies or write cite-all You can send these fonns eitherby fax to703-305-5060/ ATIN: Jennifer Brandon or email them to brandon.jennifer@epa.gov. Ifyouhave any questions or require additional infonnatio:ppleasedo not hesitate to contactme. JenniferBrandon Data Analyst (EPA Contractor) 2777 S. Crystal Drive Arlington, VA 22202 Ph: 703-305-0074 

### Fax: 703-305-5060 Email: brandon.jennifer@epa.gov

### EPA Submission: Firponil Technical Jennifer Brandon to hbjomson Cc: Sree Nair 06/08/201007:59

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

### --------------------------- -----------

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

### -**-~~** -**----~~--** Ms. Bjomson, Please direct all future calls and correspondence to the appropriate EPA Risk Manager. Thanks you, Jennifer Brandon Data Analyst (EPA Contractor) 2777 S. Crystal Drive Arlington, VA 22202 

### Ph: 703-305-0074 Fax;**703~305-5060** Email: brandon.jennifer@epa.gov

# PRIA 2

- 21 Day Content Screen Review Worksheet (EPA/OPP Use Only) 3/23/09 21 Day Screen Start Date: 5-

- Z '/

- I'0 /' 

### Experts In-Processing Signature: N 

### r'" //""e..e/,.r6Td.N 

### Date 

## S-

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### Fee Paid: Yes

# y Divisionmanagement contactedonissues No Yes Date
EPA Reg. Number: 

# s- 7c;,S-O
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# !2 EPA ReceiptDate: 

# S--2'i-IO

1

2



## 3 Itemsfor Review ApplicationForm (EPA Form 8570-1)(linkto form) signed & 

### complete including package type
Confidential StatementofFormula all boxes completed, form signed, and a) All inerts (link to http://www.epa.gov/opprdOOllinerts/), including fragrances, approved for the proposeduses (see Footnote A) Yes No N/A* 

# x 

# x

no

Certification with Respect to Citation ofData (EPA Form 8570-34) (Linkto '\...,- form) completed and signed (N/A if 100%repack) /\ Certificate and datamatrix consistent Ifapplicant is relying on datathat are compensable, is the offer to

### pay statement included. (see Footnote B)
If is there a letter ofAuthorization for exclusive use yes no

4 completed and signed (N/A

### ifsource is unregisteredor apI)licant

# '~~~~i;;;~~~~~~;:::~~~~~~~ and external copies 

### [! (N/ A if 100% 

# x**5~~~~~ ~elective**  Method b) 

### Cite-All (Fee category experts use) c) Applicant owns all data (Fee category experts use)


### 5 Copies ofLabel (linkto http://www.epa.gov/oppfeadlllabeling/lrmD 

### 6 (Electroniclabels on 

### CD are encouraged and guidanceis available)(Iinkto 

# X http://www.epa.gov/pesticides/regulating/registering/submissions/index.htm#labels

I

### 7 Is the data package consistent with PRNotice 86-5 (linkto PRN 86-5) 

# X

Notice ofFiling (link to 

### 8 

### httJ!:llwww

.cI!a.gov/nesticides/regula tinel

### tolerance Qetitions.htm) included 

# X-- withpetitions (linkto http://www.epa.gov/pesticides/regulating/tolerances.htm) 

## 9 If

### applicablefor conventional applications, reduced riskrationale (linkto 

# !x http://www.epa.gov/opprdOOllworkplan/reducedrisk.html) Required Data (link to htt!!:/ /www.cl!a.gov/(!esticides/regulatiog!dafa 

### reguirements.htm) and/or datawaivers. See Footnote C.



### a) List study (or studies) not included with application



## 10

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- Not Applicable

Footnotes A. 

### Duringthe 21 day initial contentreview, all CSFs will bereviewed to determine whether all inerts listed, includingfragrances, are approved for theproposed useS. Ifan unapproved inert is identified, the applicantmust either 1) resolve the inert issue by, for example, removing the inert, substituting itwith an approved inert, submitting documentationthat EPA approved the inertfor theproposed pesticidal uses, correcting mistakes onthe CSF, etc. or 2) providethe datato support OPP approval ofthe inertor 3) withdrawthe application. Removing or substituting an inert ingredientwill require a new CSF and may require submission ofdata. All infonnation, forms, data and documentationresolving the inert issue musthave beenreceived bythe Agency orthe applicationwithdrawnwithinthe 21 day period, otherwise. the Agency will rejectthe application as described below. To successfully complete this aspect ofthe 21 day initial content screen, applicants are strongly encouraged to verify that all inertingredients have been approved for the application's uses even if

### a productis currentlyregistered by consulting the inert Web 

## 3

### site [link to http://www.epa.gov/opprdOOllinerts/lists.html] andifthe inert is not approved, to obtain the necessary inert approvalpriorto submitting an application to register a pesticideproductcontaining thatinertingredient. Some inert ingredients are no longer approved for food uses orcertaintypes ofuses. The name and/or CAS numberon a CSFmust matchthe name and CAS number onthis web site. Simple typographical errors inthe name or CAS numberhaveresulted in processing delays. If

### an inertis not listed onthe inert ingredient web site and the applicant believes that the inerthas been approved, the applicant should contactthe InertIngredientAssessment Branch (IIAB) at inertsbranch@epa.govandresolvethe issue. Copies ofthe correspondence withlIAB resolving the issue should accompanythe application. All newinerts except PIP inerts are reviewed bylIAR. The lIAB should also be contacted for any questions on what supporting dataneeds to be submitted for and the Agency's inertreviewprocess. Questions onPIP inerts should be directedto the Chiefof Microbial Pesticides Branch [Link to http://www.epa.gov/oppbppdl/biopesticides/contactsbppd.htm]. "When abrand, trade, or proprietary name ofaninert ingredient is listed on a CSF, additional infonnation such as an alternatename ofthe inert, CAS number orother information [linkto http://www.epa.gov/opprdOOl/inertsftips.pdf] must also be included to enable the Agency to detennine ifithas been approved. Eachcomponent ofan inert mixture (including a fragrance) mustbe identified. In some cases, the supplier ofthe mixture orfragrance may need to provide this informationto the Agency. Priorto the Agency's receipt ofan application, applicants must arrange with a proprietary mixture or fragrance supplierto provide the componentinformation to the Agency or promptlyupon EPA'srequest. Ifthe inert ingredients in aproprietary blend (including fragrances) cannot or are not identifiedorprovided within the 21-day contentreviewperiod, the Agency will 

### reject the application. During the 21 day contentreview, applicants should submit information to the individual identified bythe Agency whenthe applicant is informed ofan unapproved inert. Unapproved InertsIdentified on CSFs All applications except conventional newproducts andPIPs Once an unapproved inert is identified on a CSF, the Agencywill contactthe applicantwith the following options: 1. Correct the application by, for instance, correctingthe inert's identity or CAS number, providing documentation thatthe inert has been approved, or removingthe unapproved inert from the CSF orreplacing it with one thatis approved for the application's uses; or 2. Submit the information and data needed for the Agencyto approve the unapproved inert Ifthis option is selected and implemented, the Agencymay request an extension inthe PRIA decisionreviewtimeframeto accommodate the inert review/approval process; 

### 4

### 3. Withdrawthe application (the Agency retains 25% ofthe full fee for the fee category estimated); or Ifnone ofthese options is selected and implementedbythe applicant -within the 21 day contentreviewperiod, the Agency willreject the application and retain 25% ofthe full fee ofthe category identified. Conventional New ProductApplications When the RegistrationDivisionidentifies an unapproved inert on a CSF with an application for a newproduct thatthe applicanthas notidentified as requiring an inert approval (R311, R312 or R313), itwill contactthe applicant withthe following options: 1. Correct the applicationby, for instance, correctingthe inert's identity or CAS number, providing documentationthat the inerthas been approved, or removing the unapprovedinert from the CSF orreplacing it with one that is approved for the application's uses; or 2. Submitthe information and data needed for the Agency to approve the unapproved inert, includinganyrequired petitionto establish or amend a tolerance or exemption from atolerance. (This option may change the PRIA category for the application, which could require a longerdecision review time anda largerfee. Ifadditional fees are due, they mustbe received by the Agency within the 21 day content reviewperiod.) 3. Withdrawthe application (the Agency retains 25% ofthe full fee for the fee category estimated); or
Ifnone ofthe above options is selected and implemented during the 2I-day content-reviewperiod, the Agency will reject the application and retain 25% of the appropriate fee for the new product-inert approval category. PIP Applications Whenthe Biopesticide and PollutionPrevention Division identifies an unapproved inert on a PIP CSF and a request to approve the inert does not accompanythe application, it will contactthe applicant with the following options: 1. Correctthe application by, for instance, correctingthe spelling orname ofthe inert to that in 40 CFR 174, orproviding documentationthat the inerthas been approved; or 2. Submitthe information and data needed for the Agencyto approvethe unapproved inert. Ifan inert ingredienttolerance exemption petition is required, the petitionmustbe received by the Agency and the B903 fee paid within the 21 day period. Ifthis option is selected and implemented, the Agency will discuss harmonizing the timeframe for both actions. 5

### 3. Withdrawthe application (the Agency retains 25% ofthe full fee for the fee category estimated); or Ifnone ofthe above options is selected and implemented duringthe 21 day content reviewperiod, the Agency will reject the application and retain 25% of the fee.
B. 

### A policy ondocumentation ofoffers to payis still being developed, however, for a me-too or fast track (similar/identical) newproduct, R300 or

### A530, an application withoutthe necessary authorizations ofoffers to pay will be placed into either R30 1or A53 L The Agency recommends that authorizations ofoffers to pay be submitted with other 

### PRlA applications to avoid delays inthe Agency's decision. C. Biopesticide applicants are advised to contacttheAgency and discuss studywaivers prior to SUbmitting their application to the Agency. Documentation ofsuch discussions should be submitted with the study waiver.

6

## inthe 

## 7

# Material to be added to an e-Jacket/Jacket Reg. No. 87650-1 

# Description:_N_e_W_Re_ 9i_s',_a'_ion_,
---------------- 

# 1. 

# D Placementwithin the e-Jacket/jacket: 

# D Default: (chronological, top

# = newest) 

# D File Location: (PDF page number, i.e., "before page 

# 45")

2. 

# [ZJ Send to Data Extraction contractorsthis material: 

# [ZJ Newly stamped accepted label 

# D D D Notification NewCSF Other: 3. Attach thiscoversheetto the top ofthe material orjacket. It must be well organized and clipped together, NOT STAPLED. Then give the material with this coversheetto staff in the Information Services Center (Room S-4900).
Richard Gebken 

# Reviewer's Name: ____________ _ Phone: 305-6701 

# Division: ROIIB



# -------------- 

# --------- 

# Date: January 5, 2011**~\1~0** ST..qJ: 

# . ., u.s. ENVIRONMENTAL PROTECTION AGENCY EPA Reg. Number: Date ofIssuance: 

# ;' ft ''b Office ofPesticide Programs

# ~~~ Registration Division (7505C) 

## JAN -.5 2011 '\**~<{** 

## 87650-1

'" 0 1200 PennsylvaniaAve., NW.

r..qt

### PRO"('i>~ Washington, D.C. 20460 

### NOTICE OF PESTICIDE: lerm 01, ssuance: 

# ...x. Registration Conditional

_ Reregistration (under FlFRA, as amended) Name ofPesticidc Product: 

### Fipronil Technical**I,~amc** anu**~uurcss** Oll'l.cglstrant**~mc;uue** £.Ir \..-OUC}: 

## FipronextSolutions,Inc. 3259 Harvey Court Pleasanton, CA94587
>
.. :' •.••: •.::•.:.' • ". I>'0te: c::J}apges**~:Iabeli,!(ditf?,~"g** in,'sub . 

### I'starii:'e,uom:,ti),at**accePted:iri'ConneCtio~,with** thisregistrationmustbe submfttedto

### ani acceptedbytheRegistrationDivisionprior'to'useofthe label in 'eonllnet:Ce':':Inany'corresp,ondence)n

### 'thIs prOduct always refcr.to

## the aboveEPAregistration'number.

. . •

## ••• Onthe basis ofinformation furnished bythe registrant, the above named pesticide is herebyregistcred/reregistered underthe Federal Insecticide, Fungicide and Rodenticide Act. Registration is in no way to be construed as an endorsement or recommendation ofthisproduct by the Agency. In orderto protecthealth and the environment, the Administrator, on his motion, may atany time suspend or cancel the registration ofa pesticide in accordance withthe Act. The acccptance ofany name in connection with the registration ofa product under this Actis notto be construed as givingthe registrant a right to exclusive use ofthe name or to its use ifithas been covered by others. 

### This product is conditionallyregistered in accordance with FIFRA section 3(c)(7)(A) provided thatyou: 

### L Submit and/or cite all datarequired for registration ofyourproduct under FIFRA sec 3(c)(5) when the Agency requires all registrants ofsimilarproductsto submit suchdata; and submit acceptable responses required for reregistration ofyourproduct under FIFRA section 4.

(continued on page 2)
Signaturc ofApproving Officinl: Datc:

# ~ p,,-S"-' 0 Richard

### J. Gebken, Product Manager (10) Insecticide Branch, Registration Division (7505P) EPA l'onn 3570 6 .


### Page 1 of2

### 2. Makethefollowing changetothe label:

a. Change the productregistration numberto "EPA Reg. No. 87650-1" 3. Product Chemistry: a. Within 12 months ofthe date ofthis Notice ofRegistration, you must submitacceptable Storage Stability (guideline 830.6317) and Corrosion Characteristic data (guideline 

### 830.6320) to the 

### Agency for review and approvaL

4. Submittwo copies ofthe revised final printed label for the recordbefore the product is released 

### for shipment. Ifthese conditions are not complied 

### with, the registration

## will be subjectto cancellation in accordance 

### with FIFRA section 6(e). Yourrelease for shipment oftheproduct constitutes acceptance ofthese conditions. A stamped copyofthe label is enclosed for yourrecords.

Richard J. Gebken ProductManager (10) Insecticide Branch Registration Division (7505P)

Enclosure: Label stamped "Accepted with Comments" El'AREG HO**S16So·!D""'~),DOCX**



### Page 2 of2Fipronext Fiproni! Technical label version (3) dated January 3, 2011



# FIPRONIL TECHNICAL For Use Only in the Manufacturing of Companion Animal Spot-On Insecticide/Miticide Products.
ACTIVE INGREDIENT: Fipronil: [5-amino-1-(2,6-dichloro-4-(trifluoromethyl) Page 

### 1 

### of4



### phenyl)-4-((1 ,R,S)-trifluoromethyl)sulfinyl)-1-H-pyrazole-3-carbonitrile INERT INGREDIENTS: TOTAL 98,0% 2,0% 100,0% (Fipronil CAS# 120068-37-3)



### KEEP OUT OF REACH OF CHILDREN WARNING/AVISO Si usted no entiende la etiqueta, busque a alguien para que se la explique a usted en detalle, (Ifyou do not understand this label, find someone to explain it to you,)

EPA Reg, No.: 87650-R EPA Est. No.: XXXXX-XXX-XXX Net Contents: 44 Ibs (20 Kg)

Manufactured for: Fipronext Solutions, Inc. 

### 3259 Harvey Court, Pleasanton, CA 

### 94588 

### ACCEPTED with 

### COMMENTS 

### InEPALetterDated Under

# ~~**Fe§er~11nsectictde.** Fungtc1de. and Rodenticide Act. as amended. for the**pe~UcJde** regist)

# bSb E!tReg. No_

### Fipronext Fipronil Technical label version (3) dated January 3, 

### 2011 Page20f4
FIRST AID IF SWALLOWED Immediately call poison control center or doctorfortreatment advice. Do not induce vomITing unless told to do so by a poison control center ordoctor. Have person sip a glass ofwater ifable to swallow. Do not Qive anvthino bv mouth to an unconscious person. IFON SKIN OR Take off contaminated clothing. CLOTHING Rinse skin immediately with plenty ofwaterfor**15~20** 

### minutes. Call a poison control center or doctorfor treatment advice. IF INHALED Move person to fresh air. If person is not breathing, call 

### 911 oran ambulance, then give artificial respiration, preferably by**mouth~to-mouth** 

### if possible. Call a poison control center ordoctorfor furthertreatment advice. IF IN EYES Hold eye open and rinse slowly and gently with water for 

### 15-20 minutes. Remove contact lenses, if present, afterthe first 

### 5 minutes, then continue rinsing. Call a poison control center or doctorfor treatment advice. HOT LINE NUMBER Have the product container or label with you when calling a poison control center ordoctor, or going fortreatment. You may also contact 

### 1**~800-334~7577** 

### for emergency medical treatment infonnation. NOTE TO PHYSICIAN: There is no specific antidote. All treatment should be based on observed signs and symptoms of distress in the patient. Overexposure to materials other than this product may have occurred. In severe cases of overexposure by oral ingestion, lethargy, muscle tremors, and in extreme cases, possible convulsions may occur

PRECAUTIONARY STATEMENTS HAZARD TO HUMANS AND DOMESTIC ANIMALS WARNING: May be fatal ifswallowed, absorbed through the skin or inhaled. Causes substantial but temporary eye injury. Do not get in eyes, on skin, or on clothing. Weargoggles, face shield, orsafety glasses. Wash thoroughly with soap and water after handling and before eating, drinking, or using tobacco. Wear protective clothing and rubber gloves. Remove contaminated clothing and wash clothing before reuse. Do not breathe dust. Weara dust/mist filtering respirator (MSHNNIOSH approval number prefix TC-21Cj, ora NIOSH approved respiratorwith any N, R, P or HE filter.
ENVIRONMENTAL HAZARDS This product is toxic to birds, fish, estuarine and aquatic invertebrates. Do not discharge effluent containing this product into lakes, streams, ponds, estuaries, oceans, or otherwaters unless in accordance with the requirements of a National Pollutant Discharge Elimination System (NPDES) permit and the permitting authority has been notified in writing prior to discharge. Do not discharge effluent containing this product to sewer systems without previously notifying the

### Fipronext Fipronil Technical label version (3) dated January 3, 2011 Page 3 

### of4 local sewage treatment plant authority. For guidance, contact your State Water Board or Regional Office ofthe EPA.


### DIRECTIONS FOR USE It is a violation of lawto use this product in a manner inconsistent with its labeling. Read entire label before using this product. For manufacturing use only into insecticide/miticide products • Residential indoor (companion animal) • Not for use to formulate products for termite control.



### STORAGE AND DISPOSAL Do not contaminate water, food, or feed by storage ordisposal. PESTICIDE STORAGE Store unused product in original container only, out of reach of children and animals. PESTICIDE DISPOSAL Pesticide wastes are acutely hazardous. Improperdisposal ofexcess pesticide is a violation of Federal law. Ifthese wastes cannot be disposed of by use according to label instructions, contact your State Pestic'rde or Environment Control Agency, or the Hazardous Waste representative at the nearest EPA Regional Office for guidance. In case of spill, clean up spillage using shovels and avoiding skin contact. Carefully scoop up loose material and place it in appropriate containers so as to avoid dust generation. Decontaminate tools and equipment following cleanup. In case of large scale spillage in the U.S. regarding this product, call 1-800-334-7577. CONTAINER DISPOSAL Nonrefillable container. Do not reuse or refill this container. Completely empty box into manufacturing equipment. Then dispose of empty box in a sanitary landfill or, if allowed by government regulations, by burning or incineration. If box is burned, stay out ofsmoke.

### Fipronext Fipronil Technical label 

### version (3) 

### dated January 3, 2011 Page 4 

### of4

IMPORTANT: READ BEFORE USE 

### Read the entire Directions for Use, Disclaimer ofWarranties and Limitations of Liability before using this product. Ifterms are not acceptable, return the unopened product container at once. By using this product, user or buyer accepts the following Disclaimer ofWarranties and Limitations of Liability. DISCLAIMER OF WARRANTIES: TO THE EXTENT CONSISTENTWITH APPLICABLE LAW, FIPRONEXT SOLUTIONS, INC., MAKES NO OTHER WARRANTIES, EXPRESS OR IMPLIED, OF MERCHANTABILITY OR OF FITNESS FOR A PARTICULAR PURPOSE OR OTHERWISE, THAT EXTEND BEYOND THE STATEMENTS MADE ON THIS LABEL. No agent of 

### FIPRONEXT SOLUTIONS INC. is authorized to make any warranties beyond those contained herein or to modify the warranties contained herein. TO THE EXTENT CONSISTENTWITH APPLICABLE LAW, FIPRONEXT SOLUTIONS INC. DISCLAIMS ANY LIABILITY WHATSOEVER FOR SPECIAL INCIDENTAL OR CONSEQUENTIAL DAMAGES RESULTING FROM THE USE OR HANDLING OF THIS PRODUCT. LIMITATIONS OF LIABILITY: TO THE EXTENT CONSISTENTWITH APPLICABLE LAW THE EXCLUSIVE REMEDY OF THE USER OR BUYER FOR ANYAND ALL LOSSES, INJURIES OR DAMAGES RESULTING FROM THE USE OR HANDLING OF THIS PRODUCT. WHETHER IN CONTRACT, WARRANTY, TORT, NEGLIGENCE, STRICT LIABILITY OR OTHERWISE, SHALL NOT EXCEED THE PURCHASE PRICE PAID, OR AT FIPRONEXT SOLUTIONS INC., ELECTION, THE REPLACEMENT OF PRODUCT.



### Batch Code:

## DATA PACKAGE BEAN SHEET Date:**09~Nov~201**

### 0 Page 1 of 2 

## ** * Registration Information * 

## * * Registration:**87650~R** 

### - FIPRONIL TECHNICAL Company: 87650
- FIPRONEX SOLUTIONS, INC Risk Manager: RM 10
- Richard Gebken
- (703) 305-6701 Room# PY1 S-7237 ____ _ Risk Manager Reviewer: Bonaventure Akinlosotu BAKINLOS Sent Date:

____ _ Calcula1ed Due Date: 19_Feb_2011 Type of Registration: Product Registration
- Section 3 

### Decision 

### #: 434093 

### DP 

### #: (383876) PRIA 

### Parent DP 

### #: Submission 

### #: 875251

Edited Due Date: ____ _

Action Desc: (R310) NEW PRODUCT;NON-FAST TRACK (INCLUDES REVIEWS OF PRODUCT CHEMISl

Ingredients: 129121, Fipronil{98%) 

## * * * Data Package Information 

## * * 

## * Expedite: 

## 0 Yes • No Date Sent: 09_Nov_2010 Due Back: DP Ingredient 129121, Fipronil

DPTitle: Prod Chem CSF Included: • Yes 

## 0 No Label Included: • Yes 

## 0 No Parent DP#:

Date In Date Out Organization: RD I TRB _____ Last Possible Science Due Date: 20·Jan-2011

# ,/

Team Name:**C~H~E~M~** _____ _ Science Due Date: ____ _ Rev"lewer Name:

-------- Sub Data Package Due Date: ____ _ Contractor Name: __________ _ 

## * ** Studies Sent for Review 

## ** 

## * Printed on Page 2 

## * * 

## * Additional Data Package for this Decision * 

## * 

## * No Additional Data Packages 

## * * * Data Package Instructions 

## * * 

## * For you review: MRID Nos. 481040-01 to 04 for an R310 Th, baa 703-605-0653DP#: (383876) 

## i 4ii1ri400;

48104002
48104003

48104002
48104001
48104001
48104001
48104002 48104002
48104004

48104003

48104002
48104002
48104002
48104002
48104002
48104002
48104002
48104001
48104002
48104002
48104001
48104001
48104003 ') Page 2 ***~ ~**  Sludies Sentfor Review * * *

A. Unpublished Inc. 165 p. Brookman, D. (2010) Technical Fipronil: Product PropertiesGroup B. Unpublished study prepared byTechnology Sciences Group, Inc. 11 p. Marin, J. (2010) Physical Properties: Storage Stability of Fipronil to Normal and Elevated Temperatures, Metals and Metal Ions and Determination of pH and UV Spectrum. Project Number: 1986W. Unpublished study prepared by PTRL West, Inc. 62 p. Decision#: (434093)

830.7550/PartMion coefficient (n·octanoVwater), shake flask method 

### n

830.6313/Stabilityto normal and elevated temperatures, metals, and metal ions Brookman, D. (2010) Technical Fipronil: Product Properties
- 830.6313/Stability to normal and Group B. Unpublished study prepared byTechnology Sciences elevated temperatures, metals, and Group, Inc. 11 p. metal ions Brookman, D. (2010) Technical Fipronil: Product Properties Group 830,1750fCertified**lim~s** A. Unpublished study prepared byTechnology Sciences Group, Inc. 165 p. Brookman, D. (2010) Technical Fipronil; Product Properties Group 830.1670lDiscussion offormation of A. Unpublished study prepared by Technology Sciences Group, impurities Inc. 165 p. Brookman, D. (2010) Technical Fipronil: Product Properties Group 830.1800/Enforcement analytical A. Unpublished study prepared by Technology Sciences Group, method Inc. 165p. Brookman, D. (2010) Technical Fipronil: Product PropertiesGroup B. Unpublished study prepared by Technology Sciences Group, Inc. 11 p. Brookman, D. (2010) Technical Fipronil: Product PropertiesGroup B. Unpublished study prepared by Technology Sciences Group, Inc. 11 p. 830.70S0fUVNisible absorption
830.6302/Color Marin, J. (2010) Analysis and Certification of Product Ingredienls 830.1700lPreliminary analysis in Five Batches ofTechnical Fipronil: Final Report. Project Number: 1985W. Unpublished study prepared by PTRL West, Inc. 64 p. Marin, J. (2010) Physical Properties: Storage Stability of Fipronil 830.7000/pH to Normal and Elevated Temperatures, Metals and Meta! Ions and Determination of pH and W Spectrum. Project Number: 1986W. Unpublished study prepared by PTRLWest, Inc. 62 p. Brookman, D. (2010) Technical Fipronil: Product PropertiesGroup B. Unpublished study prepared by Technology Sciences Group, Inc. 11 p. Brookman, D. (2010) Technical Fipronil: Product PropertiesGroup B. Unpublished study prepared by Technology Sciences Group, Inc. 11 p. Brookman, D. (2010) Technical Fipronil: Product PropertiesGroup B. Unpublished study prepared by Technology Sciences Group, Inc. 11 p. Brookman, D. (2010) Technical Fipronil: Product PropertiesGroup B. Unpublished study prepared by Technology Sciences Group, Inc. 11 p. Brookman, D. (2010) Technical Fipronil: Product Properties
- Group B, Unpublished study prepared by Technology Sciences Group, Inc. 11 p. Brookman, D. (2010) Technical Fipronil: Product PropertiesGroup B. Unpublished s1udy prepared by Technology Sciences Group, Inc. 11 p. Brookman, D. (2010) Technical Fipronil: Product PropertiesGroup B. Unpublished study prepared by Technology Sciences Group, Inc. 11 p. 830.7gS0Napor pressure 830.7200iMelting point/melting range 830.78401Water solubilMy: Column elution method, shake flask method 830.7S50/Partition coefficient (n·octanol/water), generalor column method 830.6303/Physical state
830.7370fDissociation constants in water 830.7300/Density/relative density Brookman, D. (2010) Technical Fipronil: Product Properties Group 830.1700IPreliminary analysis A. Unpublished study prepared by Technology Sciences Group, Inc. 16Sp. Brookman, D. (2010) Technical Flpronil: Product Properties
- Group B. Unpublished study prepared byTechnology Sciences Group, Inc. 11 p. 830.6304/0dor
Brookman, D. (2010) Technical Fipronil: Product Properties
- 830.7570/Partition coefficient Group B. Unpublished study prepared by Technology Sciences (n·octanoVwater), estimation by Group, Inc. 11 p. liquid chromatography Brookman, D. (2010) Technical Fipronil: Product Properties Group 830.1550fProduct Identity and A. Unpublished study prepared by Technology Sciences Group, composMion Inc. 165 p. Brookman, D. (2010) Technical Fipronil: Product Properties Group 830.1620/Description of production A. Unpublished study prepared byTechnology Sciences Group, process Inc. 165p. Marin, J. (2010) Physical Properties: Storage Stability of Fipronil to Normal and Elevated Temperatures, Me1als and Metal Ions and Determination ofpH and UV Spectrum. Project Number: 1986W. Unpublished study prepared by PTRL West, Inc. 52 p. 830.70501UVNisible absorptionPage 2 DP#: (383876) • * • Studies Sentfor Review·· * Decision#: (434093)

# / ! 

# I

Date: December 1,2010 

### SUBJECT:FEE. Product Chemistry Review ofFip

### ron

# 1 

# h Technical TGAI/MUP FROM: Akiva Abramovitch, Ph.D.

## ~ Technical Review Branch 

### I RD (7505P) THROUGH: Shyam B. Mathur, Ph.D. 

### ('A

## ~ " i\ 

### Product Chemistry Team Leader 

# D \j 

### DVV" 

### Technical Review Branch/RD (7505P)

# 1'-1~ 

# )0
TO, Bonaventure Akin!osotu Team Reviewer 

### I Richard Gebken Risk Manager, RM 10 Insecticide Branch 

### I RD (7505P) DP BARCODE: 0383876 DECISION No.: 434093 Registration Number/ File Symbol No.: 87650-R PRODUCT NAME: Fiproni! Technical 

## pec: 129121 REGISTRANT: Fipronext Solutions, Inc. USE: Insecticide FOOD USE: Yes [] No [X] MRID Numbers: 481040-01 through 481040-04 

### INTRODUCTION: Fipronil Teclmical is a TGA\lMUP to be incorporated into EUPs to control insects in domestic indoor applications. Group A and Group B data were submitted for the product The primary review was conducted by Oak Ridge laboratories. SUMMARY OFFINDINGS: 1. The registrant has submitted a Confidential Statement ofFonnula for a basic fonnulation (dated 5/2112010) of Fipronil Technical. The nominal concentrations ofthe active ingredient given on the CSF and product label do not match. The product label should list 2.0% "other ingredients" rather than "inert ingredients." The remaining product chemistry data submitted corresponding toguideline 830.1550 (product identity & composition) satisfy the requirements of40CFR§ 158.155 [MRlDNo. 481040-0I]. 2. The product chemistry data submitted corresponding to guideline 830.1750 (certified limits) satisfythe data requirements of40CFR§ 158.175 [MRlO 481040-01]. 3. The product chemistry data submitted corresponding to guideline reference 830.1600 (description ofmaterials used to produce the product) do not satisfy the data requirements of40CFR§ 158.160 [MRlO No. 481040-01]. 4. The product chemistrydata submitted corresponding to guideline reference 830.1620 (description ofproduction process) satisfy the data requirements for 40CFR§158.162 [MRIONo. 481040-01]. 5. The product chemistry data submitted corresponding to guideline reference 830.1670 (discussion on the formation ofimpurities) satisfy the data requirements for 40CFR§158.167 [MRlD No. 481040-01]. 6. The data submitted corresponding to the guideline reference 830.1700 (preliminary analysis) satisfy the data requirements of40CFR§158.170 [MRIO No. 481040-01].BARCODE: 0383876; Reg. No. IFILE SYMBOL No.: 87650-R; PRODUCT: Fipronil Technical

7. The data submitted corresponding to the guideline reference 830.1800 (enforcement analytical method) satisty the data requirements of40CFR§158.180 [MRlD Nos. 481040-01 and 481040-04]. 8. The data submitted corresponding to guidelines 830 Series Subgroup B (physical-chemical properties) do not satisty the data requirements of40CFR§ 158.190. Datagaps were identified for oxidation/reduction:chemical incompatibility, storage stability, and corrosion characteristics [MRID Nos. 481040-02 and 481040-02].

2BARCODE: D383876; Reg. No./FILE SYMBOL No.: 87650-R; PRODUCT: Fipronil Technical

CONCLUSIONS: The TRB has reviewed the product chemistry data submitted for Fipronil Technical TGAVMUP and has concluded that: 1). Theproduct chemistry data submitted correspondingto guidelines for 830 Series group A are acceptable, with the fonowing exceptions: a) there is a discrepancy between the eSF andproduct label concerningthe nomi.nal concentration ofactive ingredient in the product, b)the product label should use the tenn 2.0% "other ingredients" rather than "inert ingredients," and anMSDS was notprovided for one ofthe starting materials. 2). The product chemistry data submitted corresponding to guidelines for 830 Series group B are acceptable, with the foHowing exceptions: data gaps were identified for oxidation/reduction:chemical incompatibility, storage stability, and corrosioncharacteristics. 3) TRB does not objectto the conditional registration ofthis productprovided that the group B data gaps will be fulfilled (comment 2, above) and the label amendedper comments in 1, above so thatthe nominal concentration on the label matchthe nominal concentration onthe eSF.

3

### BARCODE: 

### 0383876; Reg. No./FILE SYMBOL 

### No.:**87650~R;** 

### PRODUCT: 

### Fipronil Technical



### 830.1550. Product identity & 

### Composition: (MRID No.**481040~01)** 

### Common Name: Fipronil Chemical name (CAS):**1H~Pyrazole~3~carbonitrile, 5~amino~**  

### 1**~[2,6~dichloro-4~(trifluoromethyl)phenyl]~4~ [(trifluoromethyl)sulfmyl]~**  

### (IUPAC):**5~amino·1-[2,6~dich loro~4~(** 

### trifluoromethyI)phenyI 

## H-(I,R,S

## HtrifluoromethyIsulfiny

## 0- 1Hpyrazole-3-carbonitriIe CAS No.: 120068-37-3 PCCode No.: 129121

MolecularWeight: 437.2 Structural formula:

4

### BARCODE: 0383876; Reg. No. IFILE SYMBOL No.: 87650-R; PRODUCT: Fipronil Technical

, i infonnation Ii process 

# " n IMRJD



# , 481040·04 

## II Status 

# , comments



# , II Details and for Deficiency

nominal concentrations ofthe impurities add to 1.5% on the CSF, but the total is given as 2.0%, on theproduct label. The product label should use the teon 2.0% "other ingredients" rather than "inert " 

# " n impurities i 

# ,

. Results

I Ii limits. The proposed upper limits 

# im,;;;''''''; are based on results ofthe five·

progress

5

### BARCODE: 

### 0383876; Reg. No./FILE SYMBOL No.: 

### 87650-R; PRODUCT: 

### Fipronil Technical

830 Senes 

### S b uogroup 

### B(Ph

. ICh

. IP ystca
- emtca . ) roperttes Table 2: Ph sical and Chemical Pro erUes or: Fi ronil Technical TGAI/MUP GLN Requirement MRID Status Resultor Deficiency 830.6302 Color 481040-02 A White 830.6303 Physical state 481040·02 A Solid@roomtemperature 830.6304 Odor W 830.63 t3 Stability to normal and 481040·03 A Stable@54°Cfor 14 days by itselfor in the presence of elevated temperatures, aluminum shot, aluminum acetate, copper shot, copper metals, and metal ions acetate, zinc shot, or zinc acetate. 830.63 t4 Oxidationlreduction: G chemical incompatibility 830.6315 Flammability NfA 830.6316 Explodability NfA 830.6317 Storage stability G 830.6319 Miscibility NtA 830.6320 Corrosion characteristics G 830.7000 pH 481040-02 A 6.21 (1% aqueous suspension) 830,7050 UVNisible absorptioa 481040-02 A Maximum absorbance at 200 nm Absorption coefficieats: 56,581 L morl cm-I @pH<2 57,097 Lmol"t cm-l@neutralpH 49,344 Lmol"l cm·l@pH>tO 830.7100 Viscosity NtA 830.7200 Meltingpoint 48t040·02 A**200t0201~C** 830.7220 Boiling point NfA 830.7300 Density 481040-02 A 1.477 to 1.626 g/ cm3 @20nc 830.7370 Dissociation constants in 481040-02 NfA water (DC) 830.7550 Partition coefficient 481040-02 A Log P = 4.0 830.7840 Water solubility 481040-02 A 1,9mg/L@20"C 830.7950 Vapor pressure 481040-02 A 3.7 x lOA mPa
A=Acceptable; N=unacceptable (see Deficiency); N/A '" NotApplicable; G = Data gap; I = In progress orneed upgrade; U= Up-grade (additional information required); W '" waivers 

### 6BARCODE: 0383876; Reg. No./FILE SYMBOL No.: 87650-R; PRODUCT: Fipronil Technical

830.1800. Enforcement ofanalvtical method: The enforcement analytical method is reverse phase HPLC-UV (MRlD 481 040-01). The method is described as follows:

1 Scope Determination of Fipronil in Technfcal FjpronU Using High Pressure Liquid Chromatography

This method is inlended forthe detennination of levels offipronil in Technical Fipronil. The method is applicable forfipronillevels between 90 and 105 %w. 2 Method Synopsis A weighed amount of Technical Fjpronil (the Test Substance) is dissolved in methanol/water. The solution that results is analyzed by HPLC versus calibrants containing known concentrations offipronil, using the external standard method. 3 Equipment Chromatograph. Agilent Model 1100 chromatograph equipped an autosampler and a variable wavelength ultraviolet detector and Agilent Chemstation for integration. An equivalent system can be used. Standard laboratory equipment. Analytical balance, volumetric glassware. Sonicator. 4 Reagents HPLC grade methanol. Aldrich Cat. No. 43,919-3 orequivalent. HPLC grade water: Aldrich Cat. No. 27,073-3 or equivalent. Trifluoroacetic acid (TFA): Aldrich Cat. No.30,203-1 or equivalent. Dilution Solvent. Methanol-water(70:30, v{V)**Fipron~** analytical standard. Ofknown purity (assay). ChemService (West Chester, PA, 1-610-692-3026) Cat. No. PS-2136, or equivalent. 5 Calibrant Preparation Solution A. Weigh (to the nearest 0.1 mg) approximately 60 mg of fipronil analytical standard into a 100-mL volumetric flask. Add about 85 mL methanol 10 dissolve lhe material, cool the solution ifnecessary to room temperature, and then bring the flask to volume with dilution solvent. Mix the contents of the flask by inversion. Calibrant. Use a pipet to transfer exactly 5.00 mL Solution A into a second 100-mL volumetricflask. Bring lhe flask to volume with dilution solvent, and mix its contents by inversion.

7

### BARCODE: 0383876; Reg. No./FILE SYMBOL No.: 87650·R; PRODUCT: Fipronl! Technical

6 Sample Preparation Solution B. Weigh (to the nearest 0.1 mg) approximately 60 mg ofTest Substance (Technical Fipronif) into a 1OO-mL volumetric flask. Add about 

### 85 mL methanol to dissolve the material, cool the solution if necessaryto room temperature, and then bring the flask to volume with methanol phase. Mixthe contents ofthe flask by inversion. Solution C. Use a pipet 

### to transfer exaclly 5.00 mL Solution B into a second 100-mL volumetric flask. Bring the flask to volume with dilution solvent, and mix its contents by inversion. 7 Chromatographic Conditions Establish the following chromatographic conditions. Adjustments may be made to the chromatographic conditions as required. Instrument; Guard column Detectorwavelength: Column: Column Temperature: Injection volume: Flow Rate: Mobile Phase:
Gradient HPLC equipped with uHraviolet detector (see above) Security Guard Cartridge 4.0 mm 1.d. x 2.0 mm 220nm Phenomenex Luna PFP(2), 100 mm x 2.0 mm x 3 IJm 35 C 20 IJL 0.4 mLfmin A: Water containing 0.1 % TFA B: Acetonitrile containIng 0.1% TFA

Fig. 1 shows a typical chromatogram offipronil. Under the conditions specified here, fipronil has a retention time of about 13 min.



### 8BARCODE: D383876; Reg. No./FllE SYMBOL No.: 87650-R; PRODUCT: Fipronil Technical

8 Chromatography Make replicate injections ofthe Calibrant until the areas ofsuccessive injections differ by less than 

### 1.2 %. Then make injections in the following sequence: Calibrant, Solution C, Solution C, Calibrant. Record the area ofthe fipronil peak for each injection. 9 Calculations Calculate the mean area for the fipronil peak for each solution (Calibrant and Solution C). Then use Eq. 

### 1to calculate the level offlpronil in the Test Substance.

where 

### A, A, m, m, p 

### = = = = = mean fipronil peak area for calibrant, counts; mean fipronil peak area for Solution C, counts; mass of analytical standard taken, mg; mass of Test Substance taken, mg; and purity of analytical standard, %w. Eq.1

9

### DATAEVALUATIONRECORD FIPRONIL 

### (FipronilTechnical) STUDY TYPES: ProductIdentity and Composition (OPPTS 830.1550)

PrimaryReviewer: Eric B. 

### Lewis, M.S. 

### Description ofMaterialsUsed to ProducetheProduct (OPPTS 830.1600) Description oftbeProductionProcess (OPPTS 830.1620) Discussion ofFormation ofImpurities (OPPTS 830.1670) PreliminaryAnalysis (OPPTS 830.1700) Certified Limits (OPPTS 830.1750) EnforcementAnalytical Method (OPPTS 830.1800) 

### Physicaland Chemical Characteristics (OPPTS 830.6302-830.7950) MRIDs 481040-01 through 481040-04 Prepared for Registration Division 

### Office ofPesticide Programs U.S. EnvironmentalProtectionAgency 

### One Potomac Yard 2777 SouthCrystal Drive



### Arlington, VA 22202 Prepared by 

### Toxicologyand Hazard Assessment Group Environmental Sciences Division

Oak RidgeNational Laboratory 

### OakRidge. TN 37831

Task OrderNo. I-58

Signature: Date: SecondaryReviewers: SylviaMilanez. Ph.D., D.A.B.T. 

### Signature: Date: Robert H. 

### Ross, M.S., Group Leader Signature: Date: Quality Assurance: Kimberly G. Slusher, M.S. Signature: Date: Disclaimer This review may have been altered subsequentto the contractor's signatures above. Oak Ridge National Laboratory managed and operated by UT-Battelle, LLC., for the U.S. Department ofLt.tXgy under ContractNo. DE-AC05-000R22725.

# FIPRONIL TECHNICAL For Manufacturing Use Only

ACTIVE INGREDIENT: Fipronil: 

### 5-amino-1-(2,6-d

### ichloro-4-(trifluoromethyl) 

### phenyl)-4-((1 ,R,SHrifluoromethyJ)sulfinyl) -1-H-pyrazole-3-carbonitrile

......................................................................... 98.0% 

### / ('INERi)NGREDIENTS""""',,

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

.." ,,"'" ""

..". 1'-- "'.

____ 

### .................2.0% "",

### ~!/:

# ftSiriTAL

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

### (/

### ~C( '- ........... 100.0%


# KEEP OUT OF REACH OF CHILDREN 

# WARNING
Si usted no errliende Ja etiqueta, busque a alguien para que se la expJique a usted en detalle. (If you do not understand this label, find someone to explain 

### itto you.)



### EPA Reg. No.: 87650-R EPA Est. No.: XXXXX-XXX-XXX Net 

### Contents:

Manufactured for: Fironext Solutions, Inc. 3259 Harvey Court Pleasanton, CA 94588 

### "" ,

, , , > " 

# .

", 

### , ,', ,

Fipronil Technical label version (1) dated August 19, 20tO Page 1 of4 

### , , 

### , "" ,

### IF i I call poison control center or doctor treatment advice. Do not inducevomiting unless told to do so by a poison control center or doctor. Have person sip a glass ofwater ifable to swallow.
ofwater for 15-20 minutes. 

### i , bre,atlhin,q, call 911 or an ambulance, then give p",fe,'abllv by mouth-to-mouth if possible. treatment

for Have the product container or label with you when calling a poison control**cent~r** 

### or doctor, or going for treatment. You may also contact 1-800-334-7577 for emergency medical treatment
There is no specific antidote. All treatment should be based on observed signs and symptons of 

### i 

### PRECAUTIONARY STATEMENTS HAZARD TO HUMANS AND DOMESTIC ANIMALS- WARNING: May be fatal ifswallowed, absorbed through the skin or inhaled. Causes substantial but temporary eye injury. Do not get in eyes, on skin, or on clothing. Wear goggles, face shield, or safety glasses. Wash thoroughly with soap and water after handling and before eati ng, drinking, or using tobacco. Wear protective clothing and rubber gloves. Remove contaminated clothing and wash clothing before reuse. Do not breathe dust. Wear a dust/mist filtering respirator (MSHAINIOSH approval number prefix TC-21 C), ora NIOSH approved respiratorwith any N, R, P or HE filter. SYMPTOMS OF POISONING: In severe cases ofoverexposure by oral ingestion, lethargy, muscle tremors, and, in extreme cases, possibly convulsions, may occur. ENVIRONMENTAL HAZARDS This product is toxic to birds, fish, estuarine and aquatic invertebrates. Do not discharge effluent containing this product into lakes, streams, ponds, estuaries, oceans, or otherwaters unless in accordance with the requirements of a National Pollutant Discharge Elimination System (NPDES) permit and the perm itting authority has been notified in writing prior to discharge. Do not discharge effluent containing this product to sewer systems without previously notifying the local sewage treatment plant authority. For guidance, contact your State Water Board or Regional Office ofthe EPA.

Fipronil Technical label version (1) 

### dated August 19, 2010 

### Page 2 

### of4

### DIRECTIONS FOR USE It is a 

### violation of law to use this product in a manner inconsistent with its labeling. Read entire label before using this product. Only for formulation into insecticide products. Formulators using this product are responsible for obtaining EPA registration for their formulated product which may be Jabeled for use patterns as found listed on this label. Only for formulation into products forthe following uses: • Domestic Indoor (household, etc.) Not for use to formulate products for termite control or liquid sprayable formulations for the above cited use sites. 

### STORAGE AND DISPOSAL Do not contaminate water, food, or feed by storage or disposal. PESTICIDE STORAGE Store unused product in original container only. out of reach ofchildren and animals. PESTICIDE DISPOSAL Pesticide wastes are acutely hazardous. Improper disposal of excess pesticide Is a violaflon of Federal law. If these wastes cannot be disposed of by use according to label instructions, contact your State Pesticide or Environment Control Agency, orthe Hazardous Waste representative at the nearest EPA Regional Office for guidance. In case of spill, clean up spillage using shovels and avoiding s kin contact. Carefully scoop up loose material and place it in appropriate containers so as to avoid dust generation. Decontaminate tools and equipment following cleanup. In case oflarge scale spillage in the U.S. regarding this product, call 

### 1-800-334-7577. CONTAINER DISPOSAL Nonrefillable container. Do not reuse or refill this container. Completely empty bag into manufacturing equipment. Then dispose of em pty bag in a sanitary landfill or, ifallowed by government regulations, by burning or incineration. If bag is burned, stay out of smoke.

IMPORTANT: READ BEFORE USE Read the entire Directions for Use, Disclaimer ofWarranties and Limitations of Liability before using this product. Ifterms are not acceptable, return the unopened product container at once. By using this product, user or buyer accepts the following Disclaimer ofWarranties and Limitations of Liability.

Fipronil Technical label version (1) 

### dated August 19, 2010 

### Page 

### 3 of4

### DISCLAIMER OF WARRANTIES: TO THE EXTENT CONSISTENT WITH APPLICABLE LAW, FIPRONEXT SOLUTIONS, INC. MAKES NO OTHER WARRANTIES, EXPRESS OR IMPLIED, OF MERCHANTABILITY OR OF FITNESS FOR A PARTICULAR PURPOSE OR OTHERWISE, THAT EXTEND BEYOND THE STATEMENTS MADE ON THIS LABEL. No agent ofFipronex! 

### Solutions, Inc. is authorized to make any warranties beyond those contained herein or to modify the warranties contained herein. TO THE EXTENT CONSISTENT WITH APPLICABLE LAW, 

### FIPRONEXT SOLUTIONS, INC. DISCLAIMS ANY LIABILITY WHATSOEVER FOR SPECIAL INCIDENTAL OR CONSEQUENTIAL DAMAGES RESULTING FROM THE USE OR HANDLING OF THIS PRODUCT. LIMITATIONS OF LIABILITY: TO THE EXTENT CONSISTENT WITH APPLICABLE LAW. THE EXCLUSIVE REMEDY OF THE USER OR BUYER FOR ANY AND ALL LOSSES, INJURIES OR DAMAGES RESULTING FROM THE USE OR HANDLING OF THIS PRODUCT. WHETHER IN CONTRACT, WARRANTY, TORT, NEGLIGENCE, STRICT LIABILITY OR OTHERWISE, SHALL NOT EXCEED THE PURCHASE PRICE PAID, OR AT FIPRONEXT SOLUTIONS, INC. ELECTION, THE REPLACEMENT OF PRODUCT.

Batch Code:

Fipronil Technical fabel version (1) dated August 19, 2010 page 4 of4WASHINGTON IISO 181h Slreet, N.W. Suite 1000 Washington, D,C. 20036 Telephone 202 223-4392 Fax 202 872-0745

SACRAMENTO 712 Fifth Streel Suite A Davis, CA 95616 Telephone 530 757-]298 Fax 530 757-1299

CANADA 275 Slater Streel Suite 900 Ottawa, Ontario K]P SH9 Telephone 613 247-6285 Fax 613**236~3754**

E-mail tsg@tsgusa.com http://www.tsgusa.com 

### Richard Gebken Insecticide Branch Registration Division (7504P) Office of Pesticide Products U.S. Environmental Protection Agency Room S-4900, One Potomac Yard 2777 South Crystal Drive Arlington, VA 22202·4501 May21,2010

RE: Application to Register 

### Fipronil Technical (87650-R) PRIA Category R 310
- New product, Non-fast track
Dear Mr. Gebken: 

## TECHNOlOGY"

# ~CIENCE~ GROUP INC

Technology Sciences Group, Inc., on behalf of Fipronext Solutions, Inc., is submitting the enclosed application to register Fipronil Technical (98.5% Fipronil). Included in this application for registration is the complete product chemistry data as well as a bridging argumentfor bridging the toxicity data that has been previously submitted to the Agency for similar products. The remaining data requirements are being satisfied with the "cite·all" method. You will find the following in support ofthis application: 1) Application for pesticide registration, 2) Confidential statement of formula, 3) Certification wHh respect to citation of data, 4) Data matrices (confidential and an non-confidential version), 5) Five copies ofthe proposed label, 6) Volumes 1 - 6 (refer to the transmittal documentfor specific information on each data volume), 7) Small business waiver application and supporting documentation, and 8) PRIA pre-payment receipt: Pay.gov tracking ID: 250S70L8; Agency tracking ID: 74117800617. Please do not hesitate to contact me directlywith any questions. Sincerely,

# Ccb.J~_+iA.t...

# /< ?S**~** Heather R. Bjornson Regulatory Consultant to Fipronext Solutions, Inc. Direct dial: (202) 828·8945 e·mail: hbjornson@tsgusa.com

### VOLUME 1 OF 6 OF SUBMISSION TRANSMITTAL DOCUMENT NAME AND ADDRESS OF SUBMITTER: Fipronext Soluflons, Inc. 

### 3259 Harvey Court Pleasanton, CA 94588


### REGULATORY ACTION: 

### 481040-00

PRIA Category R 310 - Application to register **Fipronil Technical**  **(87650-R).**


### TRANSMITTAL DATE: 

### May 21,2010 LIST OF SUBMITTED STUDIES: MRID VOLUME NUMBER NUMBER EPA STUDYTITLE 1 of6 

### 48104001 2 of6


### 48104002 3 of 

### 6


### 48104003 4 of 

### 6



### 48104004 

### 5 of 

### 6

48104005 6 of 

### 6

COMPANY NAME: (Transmittal Document) **Fipronil Technical**  

### Product Chemistry - Part A 

### Fipronil **Technical** Product Chemistry - Pari B 

### Fipronil **Technical** Physical Properties 

### Fipronil **Technical** Preliminary Analysis 

### Fipronil **Technical** Toxicity Bridging Discussion Fipronext Solutions, Inc.



### Page 1 of 

### 2 GUIDELINE NUMBER



### 830.1000

- 830.1900

830.6302

- 830.7950 830.6313,830.7000 830.7050
830.1700
870.1100

- 870.4300

### COMPANY OFFICIAL:
COMPANY CONTACT: Heather R. 

### Bjomson, RehGiatory

## AgT:mt Heather R. 

### Bjornson, Regulatory Agent Technology Sciences Group, Inc. 

### 1150 18th Street, N,W. Ste, 1000 Washington, DC 

### 20036 (202) 828-8945

Page 2 012Technology Sciences Group Inc. Western Division 4061 North **156!h** Drive Goodyear,,.;z 85338 Phone: (623) 535-4060**E~Mail:** iweatherston@tsgusa.com

### -.-,.,~ "'<---**-~~,;<-,.** """\ 

### /laT"Weatherston, Ph.D. I 

### I Senior Managing Consultant /

# ~__ .,."_ ,,_ .__

# ~.._

# ~n.'------/ Stephen Stabile. Registration IPRIAOmbudsperson U.S. EPA-OPP-RD One Potomac Yard 2777 South Crystal Drive Arlington VA 22202 October7,2010

SUBJECT: Change ofPRIAclassification from R330 to R310. COMPANY: Fipronext Solutions Inc, 3259, Harvey Court, Pleasanton, CA 94588. CONTACT: lain Weatherston, Ph.D., Technology Sciences Group Inc. [Contact information as per letterhead] PRODUCT: Fipronll Technical [87550-R]
Dear Mr. Schaible: As agenttor, and on behalfof Fipronext Solutions Inc., I am writing to you following receipt 

## ofan e-mail from Bonaventure Akinlosotu indicating that Team #10 has asked you to consult on the request of Fipronext to have the PRIA category oftheir application to register Fipronil Technical [87550-R] changed backfrom R330 to originally submitted R310. Given the critical nature ofthis application 

## to Fipronext I am sending you this background information so that all facts surrounding this application are available. To that end I have also attached a copy ofthe September 26 e-mail to Richard Gebken, where the applicant in an attempt and negotiation to secure a R310 classification agreed to restrict the label to denote asingle use and offered to resubma a corrected EPA Form 8570'34. The Fipronext application was submitted on May 21,2010, in the cover letter the submitter indicated (correctly) thatthe desired PRIA category was R310 and included both the Pay.gov and the Agency tracking ID's indicating that R310 PRIAfee had been prepaid. That paymentwas accepted wahout question. Data Matrices submitted were appropriate to the R310 designation for the use of"cae all" as the method for satisfying the data requirements. The Agency on review 

## ofthe application decided to reclassify

### ( Stephen Schaiblo Flpronext Solutions Inc" leUerofOctober 7, 2010 Page 2.


### the application as R330. The submitter chaUenged this, howeverthe communications with Linda Arrington were conducted overthetelephone and the reasons forthe reclassification were not clear. Itwas not until after my meeting with Richard Gebken and SA on September23 thatthe reason became clear
- therewas a clerical error on the EPAform 8670-34 where the "selective cite-aU" boxwas checked instead ofthe "cite-aU" box. Whilethe ''wrong box checked" is an admitted administrative error by the submitter, it is Important

## to note thatthrough the Front End review, which is designed to provide an administrative review ofthe application for completeness and formatting, the Agency ignored or missed that (a) the submitter was submitting a R310 application [stated in the cover letterand again on the application form (EPA Form 8570-1)J, (b) that the R310 fee was paid and accepted and (c) the factthatthe data matrices were consistentwith a cite-aU application, and accepted the "selective cite-aU" option. However, ratherthan catching the inconsistencies, theAgency noted the checked box and accepted the "selective cite-all' option and moved on with a R330 classffication. We now come to realize that aU ofworkthatwent intothe resubmission ofa new data matrix and label restricting the use-sites in August 2010 and aU 

### ofthe workto establish R310 classification could have been avoided had someone on the classification committee orthe Front End Screen noticed the discrepancies and made a phone call to the submitter for clarification. It is ourfirm contention that based on the unique 

### circumstances discussed above, where the original submission and fee are consistent with a "cite all" application, a fair and equitable resolution ofthis matterwould provide that on submission ofa new Certification with respect to data Citation (EPA Form 8570- 34) the Agency should be able to complete its review in a timely manner underthe R310 classification as originally requested. There is at least one analogous case where a technical fipronil application with a much broader label was classified as R310 and sowe can only surmise that the clerical error on the data certification box is the reason forthe classification error. And to be clear, Fipronext still agrees to the restricted use as stated in the September26 e-mail. The PRIAapproval datefor a R310 application submitted on May 21,2010would be in about December 16, 2010. Considering the simpliCity ofthe clerical error bythe submitter, compounded bythe Agency error in not identifying the inconSistency In the screening process and the resulting confusion over classification Fipronextwould be willing to accept January 14, 2011 as a firm PRIA date forthe approval this registration. Sincerely,

.

# -y..wv..W~V~

### F1PRONEXT TECHNICAL APPLICATlONS lain Weatherston to: Richard Gebken 1lI0S/20

### 10 06:42 PM 

### Cc: 

### ItJibing Lin" ShowDetails

Richard: 

### Page 1of 1

Following our conversation with Marion and you on Wednesday November 3, and taking your advice we spoke (Bob Stewart, Dave Petrick and myself) this morning with Dan Kenny about the two main fipronil issues. He 

### nstened towhatwe hadto say, asked a lot ofquesfrons and said that he would look 'Into ourconcerns

### whkh, if we have portrayed accurately, he believes thatthere is probably some reliefthat he can bring to the situations. He advised us notto cancel justyet the scheduled meeting with Lois which is due to take place on November 22. 

### Regarding the Fipronext SolutionsTechnical Firpronil application and understandingthe delays caused by both parties dueto the R330 vs R310 issues, and although he has yetto speakwith his chemistry reviewers, he said that my proposed PRIA datewas reasonable. He also indicated to getthe ball rolling Ishould write to you and propose February 10, 2011 as a client acceptable PR1A date

- so this e-mail is proposing that the Fipronex Technical Fipronil PRIA date should be renegotiated to February 10, 2011. This is notwithstandingthe potential issues which you raised concerning purity ofthefipronil and the identity and toxicity ofits impurities which we addressed with Dan. The next step regarding this and the LoradoChem CRP issues is that Dan and Iwill have another conversation nextWednesday by which time hewill have spoken to the chemists and also to Roz and we may be in a position to chart a definitive course tothe two approvals. Best regards, lain



### file:IIC:lDocurnents and SettingslrgebkenlLoca1 SettingsITemp\notesFCBCEEI-web726l... 11122/2010.,;;;;>:':.**~ ""~.**  

### Jl '\ " -"••"1.,,.;.

Fonn Approved 0\r18 No, 207(}0060 UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

### 401 M 

### Street, S.W. WASHINGTON, D.C. 20460 Paperwork Reduction Act Notice: The Public reporting burden tor this collection ofinfonnation is estimated to average 0.25 hoursper response for registralion activities and 0,25 hours per response or reregistration and special rev'lewactivities, includ'mg time or reading the instructions and completing the necessaryforms. Send comments regarding the burden or anyother aspect r:i this collection of information, including suggestions or reducing the burden to: Director, (f'P Information Management Division (2137)U.S. Envionmental Protection Agency, 401 M Street, S.w., Washington, DC 20460. Do not send the form to this address. DATA MATRIX**~aW** August 19,2010 EPA Reg. No./File Symbol Page 1 of4 

# .--..., 87650-R Appiicant'sJRegistrant Name and Address Product Fipronext Solutions, Inc. 3259 Harvey Court Frproni/ Technical Pleasanton, CA 94588 Ingredient Fipronit Guideline Reference Number Guideline Study Name <-- . MRID Number Submitter Status 

### No" OPPTS 830.1550 Product Identityand**Compos~ion** i 48104001 Fipronext Solutions, tnc. 

### OWN I 48104001 Fipronext Solulions, Inc. OPPTS 830.1600 Description ofStarting Materials 

### OWN OPPTS 830.1650 DeSCription ofJlhe Fo/mulation Process 48104001 Fipronext Solutions, Inc_ 

### OWN OPPTS 830.1670 Discussion ofthe Formation of Impurities 48104001 Flpronext Solutions, Inc, 

### OWN OPPTS 830.1700 PreliminaryAnalYS'ls 48104004 Fipronext Solutions, Inc, 

### OWN

'PTS 830.1750 Certified Limils 48104001 Fipronext Solutions, Inc.**~T** 

### OWN**~'** 48104001 Fipronext Solulions, Inc. 

### OWN OPPTS 830.1800 Enforcement Anal}tical Method



## . 

# , OPPTS 830.6302 Color 48104002 Fipronext Solulions, Inc. 

### OWN OPPTS 830.6303 Physical State 48104002 Fipronext Solutions, Inc. 

### OWN OPPTS 830.6304 Odor 

### •**"~f1:81040"2** 

### '" Fipron€<l:t Solulions, Inc, 

# ·. • 

## , , 

# .**~** " "**~** 

### OWN 

# · . · . . - OPPTS 830.6313 Stabilily (High Temperature etc) 

# · . • i8f04PO:a ; " " foj),l:0rjfxj;Sotulions, Inc. 

### OWN o •



# . , 

# . 

# - - . OPPTS 830,7000 pH 48104003 Fipronexl Solutions, Inc. 

### OWN Signature 

# ..**~** 

# .. "" Name and Title

# ~,!Zq~ 

# . . · · Date .o, o, 

# · HealherR. Bjornson, RegUlatoryConsuliant August 19, 2010 

# - . . · 

# .. · · .-,.,A .-_ ,,,,...,,..,,, m "

..., .-.__, ___ ,_
- _.,., -- ".**""r~i""c ""~il,,hIQ**  p,**---~--"-- "'.,h~;.**  n"h,**O~n~**•••**nr~:n~** IyPap Agency Internal Use CopyForm Approved OVlB No, 2070-0060 UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 401 M Street, S.W. WASHINGTON, D.C. 20460 Paperwork Reduction Act Notice: The Public reporting burden for this collection ofinformation is estimated to average 0.25 hours per response or registration activities and 0.25 hoursper response for reregistration and special reviewact"lvilies, including time Dr reading the instructions and completing the nectssaryforms. Send comments regarding the burden or anyother aspect of th'ls collection of

. information, including suggestions br reducing the burden to: Director, CPP Information Management Division (2137)U.S. Envionmental Protection Agency; 40 t M Street, S.w., Washington, DC 20460. Do not send the form to this address. DATA MATRIX

## fl~le August 19, 2010 EPA Reg. No.fFile Symbol Page 2 of4 

# l**~** 87650-R-" Applicant's/Registrant Name and Address Fipronext Solutions, Inc. 3259 Harvey Court Pleasanton, CA 94588 Ingredient Fipronll Guideline Reference Number Guideline Study Name OPPTS 830,7050 UVNisibleAbsorption OPPTS 830.7200 Melting Point OPPTS 830.7220 Boiling Point OPPTS 830.7300 Density, Specific Gravity OPPTS 830.7370 Dissociation Constant OPPTS.755017760f7770 Octanol-Water Partition Coefficient OPPTS 830.7840 Water Solubility """oT5 830.7950 Vapor Pressure**~.** OPPTS 870,1100 Acute Oral Toxicity OPPTS 870.1200 Acute Dermal Toxicity OPPTS 870.1300 Acute Inhalation ToxiCity OPPTS 870.2400 Primary Eye Irritation OPPTS 870.2500 Primary Skin Irritation Signature

# ~r2a !:"Oll ;:,........... ",I;7n_'>.1; 10.07\**!:",~~,,"":~ ~n"** **O~"",** ••**M~'n~~ ~"_"_h',,**  C

..**h~"** 

### n_ p' 

# " 0 o " " 0 o 0 lyPaperversi m _ Product Fipronil Technical

MRJD Number Submitter Status Note 48104003 Fipronext Solutions, Inc. 

### OWN 48to4002 Fipronext Solutions, Inc. 

### OWN 48104002 Fipronext Solutions, Inc. 

### OWN 48104002 Fipronext Solutions, Inc. 

### OWN 48104002 Fipronexl Solutions, Inc. 

### OWN 48104002 Fipronext Solutions, Inc. 

### OWN 48104002 Fipronext Solutions, Inc. 

### OWN 48104002 Fipronext Solutions, Inc. 

### OWN



# -- "CITE-All" See attached data submitters list PAY "CITE-All" See attached data submitters list PAY "CITE-All" See attached data submitters list PAY "CITE-All" See attached data SUbmitters list PAY "CITE-All" See aJtached data submitters list PAY Name and Title Date 00" 0 0" 0

0 o 0 0**~ ~** **~ H~6"t!.ler**  R Bjornson, RegulatoryConsullant August 19, 2010 0 " 0 0**~ ~** **~ ~**  0**~ ~** **~ ~** 

" " ,..**~** '"**~ ~**  '"**~** Agency Internal Use CopyForm Approved OMS No, 2070.-0060 UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

### 401 MStreet, S.W. WASHINGTON, D.C. 20460 Paperwork Reduction Act Notice; The Public reporting burden fur this collection ofinformation is estimated to average 0.25 hours per response or registration activities and 0.25 hours per response br reregistration and special reviewactivities, inclu:iing time for reading the instructions and completing the necessaryforms. Send comments regarding the burden or anyother aspect of this collection of information, inctuding suggestions br reducing the burden to: Director, (f'P Information Management Division (2137)U.S. Environmental Protection Agency 401 M Street. S.w., Washington, DC 20460. Do not send the form to this address. DATA MATRIX Date August 19, 2010 EPA Reg. No.lFile Symbol Page 3 of4 

# -.1 87650-R Product

### '--~""~~~O=~~~C=~~O=~---------------------------------------------------1"--------------------------------------"-------------------' Applicant's/Registrant Name and Address Fipronext Solutions, tnc. 3259 Harvey Court Fipronif Technrcaf Pleasanton, CA 94588 Ingredtent Fipronil Guidetine Reference Number Guideline Study Name MRID Number Submitter Status Note OPPTS 870.2600 Skin Sensitization "CITE-All" See attached data submitters list PAY OPPTS 870.3100 90 Day OralToxicity
- Rats "CITE-All" See attached data submillers list PAY OPPTS 870.3'150 gO Day Oral Toxicity
- Dog "CITE-ALL" See attached data submitters list PAY OPPTS 870.3250 90 Day Dermal**Toxic~y** "CITE-All" See attached data submitters list PAY OPPTS 870. 3465 90 Day Inhalaflon ToxicHy "CITE-ALL" See attached data**subm~ters** list PAY OPPTS 870.3700 Prenatal Development**Toxic~y** in Rabbits "CITE-All" See attached data submitters list PAY OPPTS 870.3700 Prenatal Development Toxicity in Rats "CITE-ALL" See attached data submitters list PAY OPPTS 870.4100 Chronic Oral Toxicity "CITE-All" See attached data submilters list PAY 

# . '" / TS 870.4200 Carcinogenicity "CITE-All" See aUached data submitters list PAY QPPTS 870.5tOO Reverse Mutation Assay "CtTE-ALL" See allached data SUbmitters tist PAY

Signature 

# . '" 

### • '" 

# . . · . • " 

# .**.~**

# (Zi3~ 

# · . · " 

# . N:;ml? afld9itle Date 

# ·

# . ·**~ ~**  "**~** " "'**~** Hoather R. Bjornson, RegulatoryConsultant August 19, 2010 

# ·. eo "**~ ~** **~**



# .**~ ~**  "**~** 

# · . . .

-- - 

# .

## ,r~'\, '.\ ""'" f**\,,~,?~,.-**

Form Approved (XIIIB No, 2070-0060 UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

### 401 MStreet, S.W. WASHINGTON, D.C. 20460 Paperwork Reduction Act Notice: The Public reporting burden ror this collection ofinformation is estimated 10 average 0.25 hours per response 6r registration activities and 0.25 hours per response or reregistration and special review aclivllies, including time -Or reading the instructions and completing the necessaryforms. Send comments regarding the burden or anyolher aspect of this collection of information, including suggestions br reducing the burden 10: Director, CPP Information Management Division (2137)U.S. Environmenla Protection Agency, 401 M Street, S.W" Washington, DC 20460. Do nol send the form to this address.



### e August 19,2010 

## '- Apptlcant's/Registrant Name and Address Fipronext Solutions, Inc. 3259 Harvey Court Pleasanton, CA 94588 tngredient Fipronil Guideline Reference Number Guideline Study Name OPPTS 870,5300 Mammalian Cell Gene Mutation OPPTS 870.5385 Chromosomal Aberration Studyin Mice OPPTS 870.6200 Acute Neurotoxicity-Rat OPPTS 870.6200 90-Day Neurotoxicity OPPTS 870.6300 Developmental Neurotoxicity OPPTS 870.7485 Metabolism and Pharmcokinetics OPPTS 870.7800 tmmunotoxicity DATA MATRIX

MRtD Number "CITE-ALL" "CITE-ALL" "CITE-ALL" "CITE-ALL" "CITE-ALL" "CITE-ALL" "CtTE-ALL" EPA Reg. No.lFite Symbot 87650-R Product Fipronfl Technical

Submttter See attachad data submitters list See attached data submitters list See attached data submitters list See allached data submillers list See allached data subm'ltters list See attached data submitters list Sea allached data submillers list Page 4 of4

Status 

### I Note PAY PAY PAY PAY PAY PAY PAY 

# ...::J.**~** 

# ,-'-----+----------1---+--------+---1----**~ I~c~**  

### "-

# '- Date August 19,2010 000 000

# S;g"'t~~ (2.

# BY----'
000 :0**Na;';a~** fille**~ ~** **~** ,.\-ier,th'<:r R. Bjornson, RegulatoryConsultantWASHINGTON 1150 lSth Street, N.W. suite 1000 Washington, D.C. 20036 Telephone 202 223·4392 Fax 202 872-0745

SACRAMENTO 712 Fifth Street Suite A Davis, CA 956t6 Telephone 530 757-t298 Fax 530 757-1299

CANADA 275 Slater Street Suite 900 Ottawa, Ontario Kl P 5H9 Telephone 6t3 247-6285 Fax 613 236-3754

E-mail tsg@tsgusa.com http://www.tsgusa.com 

## ItCHNOlOGY" 

## SCI[NC[S

GROUP 

## INC

Richard Gebken August 19, 2010 

### Insecticide Branch Registration Division (7504P) Office of 

### Pesticide Products U.S. Environmental Protection Agency Room S-4900, One Potomac Yard 2777 South Crystal Drive Arl"rngton, VA 22202-4501
RE: 

### Fipronil Technical (87650-R) 

### Submission of a revised labeling and data matrix Dear Mr. Gebken: Technology Sciences Group, Inc., on behalf of Fipronext Solutions, Inc., is submitting the enclosed data matrix and labeling to limit the uses and to change this application to a "cite-aU" to move this into the PRIA Category**~O._** 

### ..---' ._----------_.---- You will find to support of this pending application: 1) Application for pesticide registration, 2) Revised certification with respect to citation of data, 3) Revised data matrices (confidential and an non-confidential verSion), and 

### 4) Revised version of

### the proposed label (5 copies). Please do not hesitate to contact me directly with any questions. Sincerely,

# ~V\0-. Q 

# 2,r--- Heather R. Bjornson Regulatory Consultant to Fipronext Solutions, Inc. Direc1 dial: (202) 828-8945 

### e-mail: hbjornson@tsgusa.com

# FlpraDellSolDUoDSIDC.

November 16, 2010 3259 Harvey CT., Pleasanlon, CA 94568 Tel. 510-579-7685, Fax. 510-441-8900

Office of Pesticide Programs Registration Division (Mail Code 7505P) U.S. Environmental Protection Agency One Potomac Yard 2777 Crystal Drive Arlington, VA 22202 Re: Representation of Fipronext Solutions, Inc. 

### To whom it 

### may concern; Please be advised that Stanley H. Abramson, Esq, Arent Fox LLP, is serving as outside legal counsel for Fipronext Solutions, Inc. with respect 

### to any and all applications for pesticide registrations currently pending before the U.S. Environmental Protection Agency. Further, as long as Mr. Abramson is in attendance, the status of such applications can be discussed freely in the presence of my commercial partner, LoradoChem, Inc. Ifyou have anyquestions concerning this letter, please feel free to contact Mr. Abramson directly. Thank you. Sincerelyyours, 

# " ., Dr. Jibing Un Chief Executive Officer cc; Stanley H. Abramson, Esq.

## DATA PACKAGE BEAN SHEET Date: 09-Nov-20i0 Page 1 of2 

### * * * Registration Information* * 

## * Registration: 87650-R
- FIPRONIL TECHNICAL Company: 87650
- FIPRONEX SOLUTIONS, INC Risk Manager: RM 10
- Richard Gebken
- (703) 305-670t Room# PY1 S-7237 Risk Manager Reviewer: Bonavenlure Akinlosolu BAKINLOS Senl Dale: ____ _ Calculated Due Dale: 19-Feb-2011 Type of Regislralion: Product Registralion
- Seclion 3 

### Decision 

### #: 434093 DP 

### #: (383877) 

### PRIA Parent DP 

### #: Submission 

### #: 875251

Ediled Due Date: ____ _

Action Desc: (R310) NEW PRODUCT;NON-FAST TRACK (INCLUDES REVIEWS OF PRODUCT CHEMISl

Ingredienls: 129121, Fipronil(98%)


### * 

## * * Data Package Information 

### * 

## * * Expedile: 

## 0 Yes. No DP Ingredienl: 129121, Fipronil

DP Tille: Tox Dale Senl: 09-Nav-20l0 Due Back: ____ _

CSF Induded: • Yes 

## 0 No Label Included: • Yes 

## 0 No Parenl DP#:

____ _ Assigned To Date In Date Out Lasl Possible SCience Due Dale: 20-Jan-2011 / Organizalion:**"R~D~/~T~R~B** _______ _ Team Name:**cTD~X,,-** ________ _ Science Due Dale: Reviewer Name: _________ _ Sub Dala Package Due Date: ____ _ Conlractor Name: __________ _ 

### * * * Studies Sent for Review 

### * * * Printed on Page 2 

### * * 

## *Additional Data Package for this Decision 

### * * * Can be prinled on ils own page 

### * 

## ** Data Package Instructions 

### * * * For you review: MRID No. 48104005 (Rationale for request 10 bridge tox dala) for an R310 Th, baa 703-605-0653D?#: (383877)

48104005
48104005
48104005
48t04005
48104005
4810400S Page 2 ***~** * Studies Sentfor Review' • * Decision#: (434093)

### ~ii:~~::~;,~

# ..**~;oJ;~:~i ~**  i

. Toxicity Bridging 870.2600fSkin sensitization**~ ~**  study prepared by Technology Sciences Group, Inc. 48 p. Mileson, B. (2010) Technical Fipronil: Toxicity Bridging 870.2S00fAcute dermal irritation Discussion. Unpublished study prepared by Technology Sciences Group, Inc. 48 p. Mileson, B. (2010) Technical Fipronil: Toxicity Bridging 870.1100fAcute Oral Toxicity Discussion. Unpublished study prepared by Technology Sciences Group, Inc. 48 p. Mileson, B. (2010) Technical Fipronil: Toxicity Bridging 870.1200fAcute dermal toxicity Discussion. Unpublished study prepared by Technology Sciences Group, Inc. 48 p. Mileson, B. (2010) Technical Fipronil: Toxicity Bridging 870.4300fCombined chronic Discussion. Unpublished study prepared by Technology Sciences toxicityfcarcinogenicity Group, Inc. 48 p. Miteson, B. (2010) Technical Fipronil: Toxicity Bridging 870.1300fAcute inhalation toxicity Discussion. Unpublished study prepared by Technology Sciences Group, Inc. 48 p. Mileson, B. (2010) Technical Fipronil: Toxicity Bridging 870.2400fAcute eye irritation Discussion. Unpublished sludy prepared by Technology Sciences Group, Inc. 48 p.

# FIPRONIL **TECHNICAL** For Manufacturing Use Only

ACTIVE INGREDIENT: 

### Fipronil: SHami

### no-1-(2,6-dichJoro-4-(trifluoromethy

### J) phenyl)A-(

### (1 ,R,S)-trifJuoromethyJ)suJfinyl) -1-H-pyrazoJe-3-carbonitrile

......................................................................... 98.0% INERT INGREDIENTS

.................................................................................2.0% TOTAL

...................................................................................................... 100.00/0


# KEEP OUT OF REACH OF CHILDREN 

# WARNING
Si usted no entiende la etiqueta, busque a aJguien para que 5e la explique a usted en detalJe. (If you do not understand this label, find someone to explain 

### it to you.)



### EPA Reg. No.: 87650·R EPA Es!. No.: XXXXX-XXX-XXX 

### Net Contents:

Manufactured for: Fironext Solutions, Inc. 3259 Harvey Court Pleasanton, 

### CA 94588 ,)' ,

, , , > 

### "

.. 

# . ,

..
,,' ; ,), 

### ,

Fipronil Technical label version (1) dated August 19, 2010 page 1 of4 ,

# . , , , 

### ,

, ..

..

, , " > , ,



### " > , , J > 

### , "" 

### ,

### FIRST AID IF SWALLOWED Immediately call poison control center or doctorfor treatment 

### advice. Do not induce vomiting unless told to do so by a poison control 

### center or doctor. Have person sip a glass afwater if

### able to swallow. Do notgive anything by mouth to an unconscious person. IF ON SKIN OR Take off contaminated clothing. CLOTHING Rinse skin immediately with plenty of water for 15-20 minutes. Call a,poison control center or doctor for treatment advice. IF INHALED Move person to fresh air. 

### Ifperson is not 

### breathi n9, call 911 or an ambulance, then give artificial respiration, preferably 

### by mouth-to-mouth 

### if possible. Call a poison control center or doctorfor further treatment advice. IF IN EYES Hold eye open and rinse slowly and gentlywith water for 15-20 minutes. Remove contact lenses, if present, after the first 5 minutes, then continue rinsing. Call a poison control center or doctor for treatment advice. HOT LINE NUMBER Have the product container or label with you when calling a poison control center or doctor, or going for treatment. You may also contact 1-800-334-7577 for emergency medical treatment information. NOTE TO PHYSICIAN: There is no specific antidote. All treatment should be based on observed signs and sym ptons of distress in the patient. Overexposure to materials other than this product mav have occurred. PRECAUTIONARY STATEMENTS HAZARD TO HUMANS AND DOMESTIC ANIMALS- WARNING: May be fatal ifswallowed, absorbed through the skin or inhaled. Causes substantial but temporary eye injury. Do not get in eyes, on skin, or on clothing. Wear goggles, face shield, or safety glasses. Wash thoroughly with soap and water after handling and before eati ng, drinking, or using tobacco. Wear protective clothing and rubber gloves. Remove contaminated clothing and wash clothing before reuse. Do not breathe dust. Wear a dust/mist filtering respirator (MSHA/NIOSH approval number prefix TC-21C), or a NIOSH approved respirator with any N, R, P or HE filter. SYMPTOMS OF POISONING: In severe cases of overexposure by oral ingestion, lethargy, muscle tremors, and, in extreme cases, possibly convulsions, may occur. ENVIRONMENTAL HAZARDS This product is toxic to birds, frsh, estuarine and aquatic invertebrates. Do not discharge effluent containing this product into lakes, streams, ponds, estuaries, oceans, or other waters unless in accordance with the requirements of a National Poll utant Discharge Elimination System (NPDES) permit and the permitting authority has been notified in writing prior to discharge. Do not discharge effluent containing this product to sewer systems without previously notifying the local sewage treatment plant authority. For guidance, contact your State Water Board or Regional Office ofthe EPA.

Fipronil Technical label version (1) dated August 19, 2010 Page 2 of4

### DIRECTIONS FOR USE It is a violation of Jaw to use this product in a manner inconsistentwith its labeling. Read entire label before using this product. Only for formulation into insecticide products. Formulators using this product are responsible for obtaining EPA registration for their formulated product which may be labeled for use patterns as found listed on this label. Only for formulation into products for the foJ lowing uses: • Domestic Indoor (household, etc.) Not for use to formulate products for termite control or liquid sprayabJe formulations for the above cited use sites. 

### STORAGE AND DISPOSAL Do not contam inate water, food, or feed by storage or disposal. PESTICIDE STORAGE Store unused product in original container only, out of reach ofchildren and animals. PESTICIDE DISPOSAL Pesticide wastes are acutely hazardous. Improper disposal ofexcess pestic'ide is a violation of Federal law. Ifthese wastes cannot be disposed of by use according to label instructions, contact your State Pesticide or Environment Control Agency, or the HazardousWaste representative at the nearest EPA Regional Office for guidance. In case of spill, clean up spillage using shovels and avoiding s kin contact. Carefully scoop up loose material and place it in appropriate containers so as to avoid dust generation. Decontaminate tools and equipment following cleanup. In case of large scale spillage in the U.S. regarding this product, caU 

### 1-800-334-7577. CONTAINER DISPOSAL Nonrefillable container. Do not reuse or refill this container. Completely empty bag into manufacturing equipment. Then dispose of empty bag in a sanitary landfill or, ifalJowed by government regulations, by burning or incineration. If bag is burned, stay out of smoke.

IMPORTANT: READ BEFORE USE Read the entire Directions for Use, Disclaimer ofWarranties and Limitations of Liability before using this product. Ifterms are not acceptable, return the unopened product container at once. By using this product, user or buyer accepts the following Disclaimer ofWarranties and Limitations of Liability.

Fipronil Technical label version (1) dated August t9, 2010 Page 30f4

### DISCLAIMER OF WARRANTIES: TO THE EXTENT CONSISTENT WITH APPliCABLE LAW, FIPRONEXT SOLUTIONS, INC, MAKES NO OTHER WARRANTIES, EXPRESS OR IMPliED, OF MERCHANTABiliTY OR OF FITNESS FOR A PARTICULAR PURPOSE OR OTHERWISE, THAT EXTEND BEYOND THE STATEMENTS MADE ON THIS LABEL. No agent of Fipronext 

### Solutions, Inc. is authorized to make any warranties beyond those contained herein or to mOdify the warranties contained herein. TO THE EXTENT CONSISTENTWITH APPLICABLE LAW, 

### FIPRONEXT SOLUTIONS, INC. DISCLAIMS ANY liABiliTY WHATSOEVER FOR SPECIAL INCIDENTAL OR CONSEQUENTIAL DAMAGES RESULTING FROM THE USE OR HANDliNG OF THIS PRODUCT. LIMITATIONS OF LIABILITY: TO THE EXTENT CONSISTENT WITH APPliCABLE LAW. THE EXCLUSIVE REMEDY OF THE USER OR BUYER FOR ANYAND ALL LOSSES, INJURIES OR DAMAGES RESULTING FROM THE USE OR HANDliNG OF THIS PRODUCT. WHETHER IN CONTRACT, WARRANTY, TORT, NEGliGENCE, STRICT liABiliTY OR OTHERWISE, SHALL NOT EXCEED THE PURCHASE PRICE PAID, OR AT FIPRONEXT SOLUTIONS, INC. ELECTION, THE REPLACEMENT OF PRODUCT.

Batch Code:

Fipronil Technical label version (1) dated August 19, 2010 Page 4 of4

### ZZillEC/ZOlO 

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

OFFICE OF CHEMICAL SAFETY AND POLLUTION PREVENTION



## MEMORANDUM Subject: Name ofPesticide Product: FIPRONIL TECHNICAL EPA File Symbol: 87650-R DP Barcode: D383877 

### Decision No.: 434093 Action Code: R310 PC Code: 129121 Fipronil 

### From: Rick J. Whiting, Biologist /

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# l'/ {} , Technical Review Branch CTRB)**t~** 

### Registration Division (7505P) 

## T"-=-

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To: 

### Bonaventure Akinlosotu / Richard Gebken, RM Team 10 

## Insecticide Branch Registration Division (7505P) Applicant: 

### Fipronext Solutions Inc. 3259 Harvey Court Pleasanton, CA 94588

FORMULATION FROM LABEL: 

### Active IngredientCs): 129121 Fipronil (CAS No. 120068-37-3) Inert Ingredient(s):

Page 10f4 

### Total: %bywt 

### 98.0

2.0 100.0%Fipronil (PC Code 129121) EPAFile Symbol 87650-R, FIPRONILTECHNICAL 

### ACTIONREQUESTED: The Risk Manager requests: "Foryou review: MRlD No. 48104005 (Rationale for requestto bridge data) for an R31O." BACKGROUND: Fipronext Solutions Inc. has submitted a Basic Formulation CSF dated October 20, 2010, abridging argumentfor toxicity data (MRlD 48104005) and a proposed label to support the registration ofFIPRONILTECHNICAL,EPA File Symbol 87650-R. The registrant is claiming 87650-Ris substantially similar to FIPRONIL TECH,EPA Reg. No. 432- 1478 and FIPRONIL TECHNICAL, EPA Reg. No. 7969-243. The registrant is using the cite-all method ofdata support to satisfythe acute toxicity datarequirements. The following is from MRID 48104005; "Bridging Argumentto support application oftoxicity data for registered fipronil TGAI (96%) to Fipronil Technical (98.5%)"

Fipronil Teclmical (98.5% a.i.) produced by Fipronex Solutions, Inc. is expectedto be sufficiently similar intoxicityprofileto currentlyregistered fipronil technical grade active ingredients (TGAls) that the toxicitydata generatedto support these TGAls are representative ofFipronil Technical. The fipronil TGAIs registered byBASF(7969-243) and Bayer (432-1478) are both 96% a.i., as represented onthe labels. The newFipronex Fipronil Technical contains 2.6% more ofthe a.i. on a per weight basis thanthe other two TGAIs cited. AcuteToxicity The 2.6%highera.i.level in the newFipronil Technical than is inthe currently registered fipronil TGAIs is too small to have a significant impacttheresults ofthe acute toxicity studies, or alterthe Toxicity Categories identified for the product byEPA for labeling purposes. The reported results from the acute toxicity studies conducted on the currently registered fipronil TGAIs are presented inTable 1 along with the corresponding Toxicity Categories (data from: FR 62,No 119, 1997). A small increase in Fipronil Teclmicaltoxicity correspondingtothe2.6% increase in a.i., could alter the numerical results ofthe toxicity studies slightly, butwould not appreciably alter the Toxicity Category classifications. For example, the reported oral LD50 for the fipronil TGAI is 97 mg/kg, considered Toxicity Category II. Therange ofdoses that encompass Toxicity Category II is >50 to 500 mglkg. A 2.6% increase in a.i. dose is unlikelyto decrease the LD50 from 97 mglkg to 50 mg/kg or less, which would be necessaryto decrease the Toxicity Category. Thus, for labeling purposes,Fipronil Technical would beToxicity CategoryII for acute oral exposure. This same pattern holds true for the other acute endpoints offiproniltoxicity, such that all routes ofexposure would still be classified as Category II orhigher, even ifthe slight increase in a.i. in Fipronil Technical resulted in a small increase in acute toxicity. Similarly, fipronil TGAI wasnot a sensitizing agent, and a 2.6% increase in a.i. in Fipronil Technical wouldnot change that outcome.

Page 2 of4Fipronil (PC Code 129121) EPA File Symbol 87650-R, FIPRONILTECHNICAL



### Table 1. Results from acutetoxicity studies on currently registered fipronil TGAIs (FR 62 No 119 1997) 

## , , Study FipronilTGAI Toxicity Toxicity Category results Category Range Rat Acute Oral LD50

- 97 mgikg II 

### > 

### 50

- 500 mg/kg Rat Acute Dennal LD50 > 

### 2,000 mg/kg III > 

### 2,000

- 5,000 mg/kg Rat Acute Inhalation LC50 0,39 mg/L II 

### 0,05 -0,5 mg/L Rabbit Dennal Irritation Slight; clear w/in 7 II or III days RabbitEye Irritation Moderate; clear in 14 

### II Clear in 8-21 days days Dermal Sensitization Not a sensitizer COMMENTSAND RECOMMENDATIONS: ], TRE has comparedthe Basic Formulation CSFs for 87650-R, 432-!478 (dated October 2, 2007) and 7969-243 (dated August 27,2007) and concluded that the three techoica!products are toxicologically similar. 2. After searchingthe OPP electronic databases, TRB was unableto verify all ofthe acute toxicity study resultsprovided inTable 1by the Registrant. However, TRB was able to locate two documents that contained identical acute toxicityprofiles for technical Fipronil (M. Copley; Fipronil: Third Reevaluation

- Report ofthe Hazard Identification Assessment Review Committee; Health Effects Division; 061DEC/2000 and D, Drew; D360652; Fipronil: Human Health Risk AssessmentPetition to Support and Maintainthe Established Rice Grain Tolerance for Imported Rice; Health Effects Division; 22/SEP/2009). 1RB used this infonnation to generate the acute toxicity profile for 87650-R 3. The acute toxicityprofile for FIPRONIL TECHNICAL, EPA File Symbol 87650-R is as follows: Acute oral toxicity Acute dennal toxicity Acute inhalationtoxicity Primary eye irritation Primary skin irritation Dennal sensitization II 

### II II 

### III IV 

### Negative 4. Based onthetoxicity profile above, the following are theprecautionary and first aid statements for thisproduct as obtained from the Label Review System: PRODUCT 

### ID

## #: 087650-00001 PRODUCTNAME: FIPRONILTECHNICAL PRECAUTIONARY STATEMENTS SIGNALWORD: WARNING Page30f4Fipronil (PC Code 129121) EPA File Symbol 87650.R, FIPRONILTECHNlCAL


### Hazards to Humans and Domestic Animals: May be fatal ifabsorbed through skin. May be fatal ifinhaled. May be fatal ifswallowed. Causes moderate eye irritation. Do not get ineyes, on skin, or on clothing. Washthoroughly with soap and water after handling and before eating, drinking, chewing 

## gum,.using tobacco or usingthe toilet. Wear long-sleeved shirtand longpants, socks, chemical-resistant footwear, and gloves. Remove and wash contaminated clothing before reuse. Do not breathe dust. Avoid contact with eyes orclothing. [Wearprotective eyewear.J* 

# * [Protective eyewearmay be specified, ifappropriate.} 

### FirstAid: Ifon skin: Take offcontaminated clothing. Rinse skinimmediately withplenty ofwater for 15- 20 minutes. Call a poison control center or doctor for treatment advice. Ifinhaled: Move thepersonto fresh air. 

### Ifpersonis notbreathing, call 911 or an ambulance, thengive artificial respiration, preferably mouth-to-mouth ifpossible. Call a'poison control center or doctor for further treatment advice. Ifswallowed: Call apoison control center or doctor immediately for treatment advice. Have person sip a glass ofwater ifableto swallow. Do not induce vomiting unless told to by apoison control center or doctor. Do not give anything to an unconscious person. Ifineyes: Hold eye open and rinse slowly and gently with water for 15-20 minutes'. Remove contact lenses, ifpresent, after the first 5minutes, then continue rinsing. Call apoisoncontrol center or doctor for treatment advice. Have the product container or label with you when calling apoisoncontrol center ordoctor or going for treatment. You may also contact 1-800-xxx-xxxxfor emergency medical treatment information. 5. In addition, TRB notedthattheregistranthas included additional Precautionary statements. TRB finds this additional labeling information acceptable. 6. The Basic FormulationCSF dated October20,2010 for theproposed technical product should also bereviewed and accepted by the TRE Product Chemistry Team 7. This memorandumpertains only to thedecision concerning whetherthe subject product is similarto the cited product from an acutetoxicological viewpoint. Forthepurposes ofthis action, TRB has madeno further determination ofthe adequacy ofthetoxicological database or theprecautionary label ofthe citedproduct.

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# (5l UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 401 M Street, S.W. WASHINGTON, D.C, 20460 Paperwork ReductionAct Notice: The public reporting burden for this collection of information is estimated to average 0.25 hours pe,**l~~pon~e** for**re~idt,atio), actlvitif>~**  iI,ld 0.25 hours per response for reregistration and special review activities. including time for reading Ihe instructions and completing the necessaryforms. Send comments regarding the burden estimate or any other aspect ofthis collect1on of intormalion, includIng suggestions for reducing the burden to: Direclor. OPPE information Management Dlvision (2137). U.S. Environmenlal ProlectionAgency. 401 M Street. S.W., Washinglon, DC 20<160. Do not send the form to Ihis address. 

### DATA MATRIX Date 10/2012010 EPA Reg NO.fFile Symbol 87931-R Page 1**~f** 4 Applicant'slRe!'listrant's Name &Address Product RAYMAT MATERIALS INC., 30081 Ahern Ave.• Union Cily. CA 94587 FIPRONIL TECHNICAL Ingredient Fipronil (PC Code 129121) Guideline Reference Number Guideline Sludy Name MRID Number Submilier Status Note 830.1550 Product identity and composition this submission Raymat Materials Inc. PER see LOA 830.1600 Description of materials used to produce Ihe producl this submission Raymat Materials Inc. PER see LOA 830.1620 Description ofproduction process this submission Raymat Materials Inc. PER see LOA 830.1670 Discussion offormation ofimpurllies Ihis submission Raymat Materials Inc. PER see LOA 830.1700 Preliminaryanalysis this submission Raymat Malerials Inc, PER see LOA 830.1750 Cerlifled limits this submIssion Raymat Materials Inc. PER see LOA 830.1800 Enforcement analytical method this submission Raymat Materials Inc. PER see LOA 830.1900 Submittal fo samples th'ls submission Raymat Matenals Inc. will submHif requesled 830.6302 Color Ihis submission Raymat Materials Inc. PER see LOA 830,6303 Physical slate this submission Raymat Materials Inc. PER see LOA 830.6304 Odor Ihis submission Raymat Materials Inc. PER see LOA 830.6313 Stability 10 temperatures. metals and metal ions this submission Raymat Materials Inc. PER in progress 830.6314 Oxidatlonlreduction; chemical incompatability this submission Raymat Malerials Inc. PER seelDA 830.6315 Flammability this submission Raymat Materials tnc. PER see LOA 830.6316 Expodabllity this submission Raymat Materials Inc. PER see LOA Signature 

# \.. •

# .W~V"'~ Name and Title Date**~** lain Weatherston Senior Regulatory Consultant 

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## ~ 401 MStreet, S.W. WASHINGTON, D.C. 20460 Paperwork ReductIon Act NotIce: The public reporting burden for this collection ofinformation is estimated to average 0.25 hours pel**r..l~pon~e** for re!.bbatior. acti"itieJ J"d**O.~5** hours per response for reregistration and special review activities, inctudlng time for reading the instructions and completing the necessary forms. Send comments regardIng the burden estimate or any other aspect ofthis collection of information, including suggestions fOf reducing the burden to: Director, DPPE Information Management Division (2137), U.S. Environmental Protection Agency, 401 M Street, S.W., Washington, DC 20460. Do not send the form to this address. 

### DATA MATRIX Date 10/2012010 EPA Reg No.lFIle Symbol 87931-R 

# I Page2

### ~f 4 Applicant'sIReQlstrant's Name &Address Product RAYMAT MATERIALS tNC., 30081 Ahern Ave., Union City, CA94587 FtPRONIL TECHNICAL tngredlent Fipronit (PC Code 129121) Guideline Reference Number Guideline Study Name MRtD Number Submitter Status Note 830.6317 Storage stability this submission Raymat Materials Inc. PER in progress 830.6319 Miscibility this submission Raymat Materials Inc. not applicable 830.6320 Corrosion characteristics this submission Raymat Materials Inc. PER lin progress 830.6321 Dielectric breakdown constant this submission Raymat Materials Inc. not applicable 830.7000 pH this submission Raymat Materiats Inc. PER see LOA 830.7050 UVlvisible light absorption this submission Raymat Materials Inc. PER see LOA 830.7100 Viscosity this submission Raymat Materials Inc. PER see LOA 830.7200 Metttng point range thiS submission Raymat Materials Inc. PER see LOA 830.7220 8010ng point range this submission Raymat Materials tnc. PER see LOA 830.7300 Density/relaUve density/bulk density this submission Raymat Materials Inc. PER see LOA 830.7370 Dissociation constant this submission Raymat Materials Inc. PER see LOA 830.7520 Particle size/flber length this submission Raymat Materials tnc. not applicable 830. 7550, 7560, 7570 Partition coefficient this submission Raymat Materials tnc. PER see LOA 830.7840,7860 Water solubitity this submission Raymat Materials Inc. PER see LOA 830.7960 Vapor pressure this submission Raymat Materiels Inc. PER see LOA Signature 

# ( •

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# - WASHINGTON, D.C. 20460 Paperwork RedUction Act Notice: Tho pubUe reporttng burden for this collection of information is estimated to average 0.25 hours per**r.J~ponta** for re!,iLliatiot. ac!ivitie" JI ,d 0.:5 hours per response for reregistration and special review activities, including time for reading the instructions and completing the necessary forms. Send comments regarding the burden estimate or any other aspect ofthis collection of information, including suggesfions for reducing the burden 10: Director, OPPE Information Management Division (2t37), U.s. Environmental Protection Agency, 401 M Street, S.w •• Washington, DC 20460. Do nol send tha form tothls address. DATA MATRIX Oale 10/20/2010 EPA Reg No.lFile Symbol 87931·R 

# IPage 3 Jf 4**App~canl's/ReQistranl's** Name &Address Product RAYMAT MATERIALS INC., 30081 Ahem Ave., Union City, CA 94587 FIPRONtL TECHNICAL Ingredient Fipronil (PC Code t29121) Guideline Reference Number Guideline Study Name MRID Number Submijler Slatus Note ALL OTHER OATA REQUIREMENT ALL OTHER DATA REQUIREMENTS ARE SATISFIED BYTHE CITE· ALL METHOD OF DATA SUPPORT 40 CFR152.86 CONUM 100 Syngenta Crop Protection Greensboro, 

### NC 27419 239 The Scotts Company Marysville 

### OH 43030 264 Bayer Crop Science 2 T.W. Alexander Dr., Research Trianle Park 

### NC 27709 499 Whitmire Micro-Gen Research Laboratories 3568 Tree Court Industriat Blvd., St Louis 

### MO 63122 2382 Vlrbac AH tnc. 13001 St Charles Rock Road, Bridgeton 

### MO 63044 2517 Sergeant's Pet Care Products, tnc. 2625 South t58th Plaza, Omaha 

### NE 68130 3282 Reckitt Benkiser Inc. 399 tnterface Parkway, Parsippany 

### NJ 07054 4787/67760 Cheminova NS t600Wilson Blvd., Suite 700, Artington 

### VA 22209

, 7946 J.J. Mauget Co., 12733 Director's Loop, Woodbridge 

### VA 22192 7969 BASF Corporation 26 Davies Drive, Research Triangle Park 

### NC 27709 9688 Chemsico St Louis 

### MO 63 ff4 t1678 Makhteshim Chamlcat Works Ltd. 45t5 Falls ofNeuse Rd., Suite 300, Rateigh 

### NC 27609 53883 Control Solution Inc., 427 HideAway Circle, Cub Run 

### KY 42729 54072 

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### TX 76162 Signature

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### DATA MATRIX Date 10/20/20tO EPA Reg No.lFite Symbol 87931-R 

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### ~f 4 App)icant'sfReQistrant's Name &Address Product RAYMAT MATERIALS INC., 30081 Ahem Ave., Union City, CA 94587 FIPRONIL TECHNICAL Ingredient Fipronil (PC Code 129121) Guideline Reference Number Guideline Study Name MRID Number Submitter Stalus No< 64240 Combat Insect Control Systems 122 C Street, N.w. Suite 740, Washington DC 2000 t 65331 Meriallimited 3239 Satellite Blvd., Bldg 500, Duluth GA 30096 66607 Sprat Drift Task Force 1900 K Street, NW., Washington DC 20006 71754 Outdoor Residential Task Force 1350 I Street, N.W. Washington DC 20005 73342 Armbrands Salem VA 24153 73766 tnnovative Pest Control Products Boca Raton FL 33488 73989 FtFRA Endangered Species Task Force 1350 I**Strre~** NW., Washington DC 20005 74054 trvita Ptant Protection N.V. 4515 Falls ofNeuse Roard, Suite 300, Raleigh NC 27609 74888 Residential Exposure JointVenture 900 17th Street NW Suite 300, Washington DC 20006 75234 Agriculturat Handlers Exposure Task Force 1720 Prospect Drive, Macon MD 63552 88230 LoradoChem Inc., 4061 North 156th Drive, Goodyear AZ 85395 87467 Argite
- Fipronil LLC 4110, 1136th Street NW., Gig Harbor WA 98332 87650 Fipronext SoluHons tnc. 1150 18th Street, NW Suite 1000 DC 20036 

# / Signature

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Date August 19, 2010 EPA Reg. NoJFHe Symbol Page 1 of4**~-~** 87650"R ApPticant's/Registrant Name and Address Product Fipronext Solutions, tnc. 3259 HarveyCourt Frpronil Technical Pleasanton, CA 94588 tngredient Fipronil Guideline Reference Number Guideline Study Name 

### C'\ MRtD Number Submitter Status 

### Note OPPTS 830.1550 Product Identityand Composition 

# I 48104001 Fipronext Salulions, Inc. 

### OWN OPPTS 830.1600 Description ofStarting MaterialS 

# , 48104001 Fipronext Solutions, Inc. 

### OWN OPPTS 830.1650 Description oflthe Formulation Process
. 48104001 Fipronext Solutions, Inc. 

### OWN OPPTS 830. t670 Discussion ofthe Formation of Impurities 48104001 Fipronext Solutions, Inc. 

### OWN OPPTS 830.1700 PreliminaryAnalysis 48104004 FiprOnext Solutions, Inc. 

### OWN 48104001 Fipronext Solutions, tnc. 

### :...--.-( OPPTS 830.1750 Certified**Lim~s** 

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# , 4810400t FiprOnext Solutions, Inc. 

### OWN OPPTS 830.1800 Enforcement**Anal~ical** Method 

# , (_.-**-.~-** OPPTS 830.6302 Cotor 48104002 Fipronext Solutions, tnc. 

### OWN OPPTS 830.6303 Physical State 48104002 Fipronexl Solutions, Inc. 

### OWN OPPTS 830.6304 Odor 0 "**~81040@2** 000 Fhoron€!.>l:t Solutions, Inc. 

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### '" .0 0 Heather R. Bjornson, RegulatoryConsul\ant August 19, 2010 , 

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Form Approved OIIIB No, 2070-0060 UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 401 M Street, S.W. WASHINGTON, D.C. 20460 Paperwork Reduction Act Notice: The Pi.blic reporting burdenforthis collecflon ofinformarion is estimated to average 025 hours per response 6r registration activifles and 0.25 hoursper response for reregistration and speciat reviewactivities, including time br reading the instructions and compteting the neCESsaryforms. Send comments regarding the burden or anyother aspect of this colleclion of information, inctuding suggestions br reducing the burden to: Director, CPP Information'Management Division (2137)U.S. Envionmentat Protection Agency, 401 M Street, S.W., Washington, DC 20460. Do not send the form to this addreSS. DATA MATRIX Date August 19, 2010 EPA Reg. No.fFite Symbol Page 2 of4 ) 87650·R**-~** Appllcant's/Registrant Name and Address Fipronext Solutions, tnc. 3259 Harvey Court Pleasanton, CA94588 tngredient Fipronil Guideline Reference Number Gutdeline Study Name OPPTS 830.7050 UVNisibleAbsorption OPPTS 830.7200 Melting Point OPPTS 830.7220 Boiling Point OPPTS 830.7300 Density, Spec"lficGrav'lty OPPTS 830.7370 Dissociation Constant OPPTS.7550rr760{7770 Octanot Water Partition Coefficient OPPTS 830.7840 Water Solubility OPPTS 830.7950 Vapor Pressure
OPPTS 870. t toO Acute Oral Toxicity OPPTS 870.1200 Acute Dermal Toxicity DPPTS 870.1300 Acute tnhalation Toxicity OPPTS 870.2400 Primary Eye Irritation OPPTS 870.2500 Primary Skin trritation Signature

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### 401 M 

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Date August 19, 2010 Applicant's/Registrant Name and Address Fipronext Solutions, Inc. 3259 Harvey Court Pleasanton, CA 94588 Ingredient Fipronil Guideline Reference Number Guideline Study Name OPPTS 870.2600 Skin Sensitizat"ion OPPTS 870.3100 90 Day Oral Toxicity
- Rats OPPTS 870.3150 90 Day Oral Toxicity- Dog OPPTS 870.3250 90 Day Dermal Toxicity DPPTS 870, 3465 90 Day Inhalation Toxicity OPPTS 870.3700 Prenatal Development Toxicity in Rabbits OPPTS 870.3700 Prenatal Development Toxicity in Rats OPPTS 870.4100 Chronic Oral Toxicity OPPTS 870.4200 Carcinogenicity QPPTS 870.5tOO Reverse Mutation Assay**Slgn,,",.~** 

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MRID Number 'CITE-ALL" "CITE-ALL" "CITE-ALL" "CITE-ALL" "CITE-ALL" "CITE·ALL" "CITE-ALL" "CITE-ALL" "CITE-ALL' "CITE-ALL"



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# ". EPA Reg. No.fFile Symbol 87650-R**"~"I** Applicant'slRegistrant Name and Address Fipronexl Solullons, Inc. 3259 Harvey Court Pleasanlon, CA 94588 Ingredient Fipronil Guideline Reference Number Guideline Study Name OPPTS 870.5300 Mammalian Cell Gene Mutalion OPPTS 870.5385 Chromosomal Aberration Siudyin Mice OPPTS 870.6200 Acule Neurotoxicily ·Ral OPPTS 870.6200 90·0ay Neuroloxicity OPPTS 870.6300 Developmental Neuroloxicity OPPTS 870.7485 Metabolism and Pharmcokinetics OPPTS 870.7800 Immunotoxicily

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## ~ 401 M Street, S,W. WASHINGTON, D.C, 20460 Paperwork Reduction Act Notica: The**pub~c** reporting burden for this collection oflnformalion is estimated 10 average 0.25 hours pe, l<l

..**pon~e** for re!licil,atiol, actMIlr,<l a,le! 0.25 hours per response for reregistration and special review activities, Including lime for reading the instructions and completing the necessary forms. Send comments regarding the burden estimate or any other aspect oflhls cOllection of infonnaUon, including suggestions fOf reducing the burden 10: Director, OPPE tnfonnalion Management DiVision (2137). U.S. Environmental Protection Agency, 401 M Street, S.W" Washington, DC 20460. Do not send the form to this address. 

### DATA MATRIX Date 1Of20/20fO EPA Reg No.lFile Symbol 8793f-R 

# I Pagel 3f 4 AQPllcant'sIReQislrant's Name &Address Producl RAYMAT MATERIALS INC., 3008f Ahern Ave., Union City, CA 94587 FIPRONIL TECHNICAL Ingredient Fipronil (PC Code 129f2l) Guideline Reference Number Guideline Study Name MRID Number Submitter Stalus Note 830. f550 Product idenllly and composIlion this submission Raymat Materials Inc. PER see LOA 830.1600 Description 01 malerials used to produce the product this submission Raymal Materials Inc. PER see LOA 830.1620 Descriplion ofproduction process Ihis submission Raymat Materials Inc. PER see LOA 830.1670 Discussion offormation ofimpurilies this submission Raymat Materials Inc. PER see LOA 830.1700 Preliminary analys·ls Ihls submission Rayrnat Materials Inc. PER see LOA 830. f750 Certified IImiis this submission Raymat Materials Inc. PER see LOA 830. raoo Enforcement analytical method this submission Raymal Materials Inc. PER see LOA 830.1900 Submillal fo samples Ihis submission Rayrnat Materials Inc. will submH if requesled 830.6302 Color this submission Raymat Materials Inc. PER see LOA 830.6303 Physical state this submission Raymat MaterialS Inc. PER see LOA 830.6304 Odor this submission Raymat Malerials Inc. PER see LOA 830.63f3 Stebility 10 temperatures, metals and metal ions this submission Raymat Materials Inc. PER in progress 830.63 f4 Oxidalion/reduction; chemical incompalability this submission Raymat Materials Inc. PER see LOA 830.63f5 Flammability Ihis submission Raymat MaterialS Inc. PER see LOA 830.6316 

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# .W~V-~ Name and Tille Dale lain Wealherslon Senior Regulatory Consullant 

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### WASHINGTON, D.C, 20460 Paperwork Reduction Act Notice: The pullitc reporting burden for this coliedion ofinformation is estimated 10 average 0.25 hours pel**r..!~pon~e** for**re!.i~llatior,** activitieJ .l"a 0.:::5 hours per response for reregistration and special review activities, including time for reading the InslrucUons and completing the necessary forms. Send comments regarding the burden**es~male** or any other aspect ofthis collection of information, including suggestions for reducing the burden to: Director, DPPE Information Management Division (2137). U.S. Environmental Prolecijon Agency. 401 MStreet, S,W., Washington, DC 20460. Do not send the fonn to this address. DATA MATRIX Dale 10/20/2010 EPA Reg No/FIeSymbol 87931-R 

# I Page2 Jf 4**App~cant'slRe!lislrant's** Name &Address Product RAYMAT MATERIALS INC., 30081 Ahern Ave., Union City, CA 94587 FIPRONIL TECHNICAL Ingredient Flpronil (PC Code 129121) Guideline Reference Number Guideline Study Name MRID Number Submitter Slatus Nole 830.6317 Storage**stabi~ty** this submission Raymat Malerials Inc. PER in progress 830.6319 Miscibility Ihis submission Raymat Materials Inc. not applicable 830.6320 Corrosion character'lslics this submission Raymat Materials Inc. PER nn progress 830.6321 Dielectric breakdown constant this submission Raymat Materials Inc. not appltcable 830.7000 pH Ihis submission Raymat Materials Inc. PER see LOA 830.7050 UV/visible light absorption this Submission Raymat Materials Inc. PER see LOA 830.7100 ViscosHy Ihis submission Raymat Materials Inc, PER see LOA 830.7200 Melling point range Ihis submission Raymat Materials Inc. PER see LOA 830.7220 Boiling point range this submission Raymal Materials Inc. PER see LOA 830.7300 DensilyIrelative densitylbulk density this submission Raymat Materials Inc. PER see LOA 830.7370 Dissociation conslant Ihis submission Raymat Materials Inc. PER see LOA 830.7520 Particle sizelfiber length this submission Raymat Materiels Inc. not applicable 830.7550,7560,7570 Partition coefficient this SUbmission Raymat Malerials Inc. PER see LOA 830.7840,7860 Water solubility Ihls submission Raymat Materials Inc. PER see LOA 830.7960 Vapor pressure Ihis submission Raymat Materials Inc. PER sea LOA Signaltlre 

# ( •

# ~:>~ Name and Title Dale 

# r. ... lain Wealherston Senior Regulalory Consullant 10/20/2010 EPA Form 8570-35 (9-97) Electron''()lnd Paper versions available. Submit only Paper version. Agency Internal Use Copy**~** m 

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# - Paperwork Reduction Act Notice; The public reporting burden for this collec1ion of information Is estimated 10 average 0.25 hours per r-ltpont.a for re!,i!,lIalior. activilie.; JI,d 0.:5 hours per response for reregistration and special review activities, including tima for reading the instructions and completing the necessary forms. Send comments regarding the burden estimate or any other aspect ofthis collection of infonnalion, Including suggestions for reducing the burden \0: Direc!or, OPPE Infonnafton Management Division (2137), U.S. Environmental Protection Agency. 401 M Street, S.w., Washington, DC 20460. Do not send file form to this address, DATAMATRlX Date 10/20/2010 EPA Reg No,lFile Symbot 87931·R 

# I Page3 )f 4 Appticanl's/Registranl's Name &Address Product RAYMAT MATERIALS INC" 30081 Ahern Ave" Union City, CA 94587 FIPRONtL TECHNICAL Ingredient Fipronil (PC Code 129121) Guideline Reference Number Guideline study Name MRID Number Submitter Status Note ALL OTHER DATA REQUIREMENT ALL OTHER DATA REQUIREMENTS ARE SATISFIED BYTHE CITE· ALL METHOD OF DATASUPPORT 40 CFR152.86 CONUM 1()() Syngenta Crop Protection Greensboro, 

### NC 27419 239 The Scotts Company Marysville 

### OH 43030 264 Bayer Crop Science 2 T.W. Alexander Dr., Research Trianle Park 

### NC 27709 499**Wh~mire** Mlcro-Gen Research Laboratories 3568 Tree Court tndustrial Blvd., St Louis 

### MO 63122 2382 Vlrbac AH tnc. 13001 St Charles Rock Road, Bridgeton 

### MO 63044 2517 Sergeant's Pet Care Products, Inc. 2625 South 158th Plaza, Omaha NE 68130 3282 Reckitt Benkiser Inc. 399 tnterface Parkway, Parsippany 

### NJ 07054 4787 f67760 Cheminova NS 1600 Witson Blvd., Suite 700, Arlington 

### VA 22209 7946 J,J, Mauget Co., 12733 Director's Loop, Woodbridge 

### VA 22192 7969 BASF Corporation 26 Davies Drive, Research Triangle Park 

### NC 27709 9688 Chemsico st Louis 

### MO 63114 11678 Makhteshim Chemical Works Ltd. 45f5 Faits ofNeuse Rd., Suite 300, Raleigh 

### NC 27609 53883 Controt Sotution Inc., 427 Hide Away Circte, Cub Run KY 42729 54022 

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# --- 

# -- Paperwork Reduction Act Nottce: The public reporting burden for this coliecUon of information is estimated to average 0.25 hours pel**rJ~pon~e** for re!,k.\lalior. activltieJ J.ild**O.~5** hours per response for reregistration and special relliew activities, including time for reading the Instructions and completing the necessaryforms. Send comments regarding the burden estimate or anyotheraspect ofthis collacHon of information, Including suggestions for reducing the burden to: Director, OPPE Information Management Division (2137), U.S. Environmental Protection Agency. 401 M Street, S.w., Washington, DC 20460. Do not send the form to this address. 

### DATA MATRIX Date 10/20/2010 EPA Reg No.lFlle Symbol 87931-R 

# I Page4 Jf 4 Anpltcant'slReQlstrant's Name &Address Product RAYMAT MATERIALS INC., 30081 Ahern Aue., Union City, CA94587 FIPRONIL TECHNICAL Ingredient Flpronil (PC Code 129121) Guideline Reference Number Guideline Study Name MRID Number Submiller Status Nole 64240 Combat InsectControl Systems 122 C Street, N.W. Suite 740, Washington DC 20001 65331 Meriallimited 3239 Satellite Blud., Bldg 500, Duluth GA 30096 66607 Sprat Drift Task Force 1900 K Street, NW., Washington DC 20006 71754 Outdoor Residential Task Force 1350 I Street, N.w. Washington DC 20005 73342 Armbrands Salem VA 24153 73766 InnovaUve Pest Control Producls Boca Raton Fl 33488 73989 FIFRA Endangered SpeciesTask Force 1350 I Strret, NW., Washington DC 20005 74054 Irvita Planl Protection NV. 4515 Falls ofNeuse Roard, Suite 300, Raleigh NC 27609 74888 Residential Exposure Joint Venture gOO 17th Street NW S,-!ite 300, Washington DC 20006 75234 Agricultural Handlers Exposure Task Force 1720 Prospect Drive. Macon MD 63552 86230 LoradoChem Inc., 4061 North 156lh Drive, Goodyear AZ 85395 87467 Argite • Fipronil LLC 4110, 1136th Sireet NW., Gig Harbor WA 98332 87650 Fipronext Solutions Inc. 1150 18th Street, NW Suite 1000 DC 20036 

# / Signature 

# (


# -**,W~~** Name and Title Date lain Weatherslon Senior Regulatory Consultant 

# ! 10120/2010 EPA Form 8570-35 (9-97) Electronic 

### J Paper uerslons auailable. Submit only Paperversion. Agency Internal Use Copy 

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# ::;Technology S.ciellces Group Inc. Western Division 4061 North 1561/1 Drive Goodyear,

### p.z.85338 Phone: (623) 535-4060 E-Mail: iweatherston@tsgusa.com

## -~**/1~~herston,** Ph.D. "'\ { Senior Managing Consultant /

# ~--~-----~ Stephen Stabile Registration IPRllI Ombudsperson U_S_ EPA
- OPP -RD One Potomac Yard 2777 South Crystal Drive Arlington VA 22202 October 7, 2010

SUBJECT: Change of PRIA classification from R330 to R310_ COMPANY: Fipronext Solutions Inc, 3259, Harvey Court, Pleasanton, CA 94588. CONTACT: lain Weatherston, Ph.D., Technology Sciences Group Inc. [Contact information as per letterhead] PRODUCT: Fipronil Technical [87550-RJ
Dear Mr. Schaible: 

### As agentfor, and on behalfof Fipronext Solutions Inc., I amwriting to you following receipt ofan e-mail from BonaventureAklnlosotu indicating thatTeam #10 has asked you to consult on the request of Fipronext to havethe PRIA category oftheir application to register Fipronil Technical [87550-R] changed backfrom R330 to originally submitted R310. Given the critical nature 

### ofthis application 

# to Fipronext Iam sending you this background Information so thatall facts surrounding this application are available. To that end I havealsoatlached a copy ofthe September 26 e-mail to Richard Gebken, where the applicant in an attemptand negotiation to secure a R310 classification agreed to restrict the label to denote a single use and offered to resubmit a corrected EPA Form 8570'34. The Fipronext application was submitted on May 21, 2010, in the cover letterthe submitter indicated (correctly) thatthe desired PRIAcategory was R310 and included both the Pay.gov and the Agencytracking lo's indicating that R310 PRIAfee had been prepaid. That paymentwas accepted without question. Data Matrices submitted were appropriate to the R310 designation forthe use of"ctte all" as the method for satisfying the data requirements. TheAgency on review ofthe application decided to reclassifySlephen Schalbla Flpronext Solutions Inc., letter ofOctober7, 2010 Page2. 

### the application as R330. The submitter challenged this, howeverthe communications with Linda Arrington were conducted overthetelephone and the reasons forthe reclassification were not clear. Itwas not until alier my meeting with Richard Gebken and BA on September23 that the reason became clear
- there was a clerical erroron the EPAform 8670-34 where the "selective ctte-all" boxwas checked instead ofthe "cite-all" box. While the "wrong box checked" is an admitted administrative error bythe submitter, it is important to note that through the Front End review, which is designed to provide an administrative review ofthe application for completeness and formatting, the Agency ignored or missed that (a) the submitterwas submitting a R310 application [stated in the cover letterand again on the application form (EPA Form 8570-1)J, (b) that the R310 fee was paid and accepted and (c) the fact that the data matrices were consistentwith a ctte-all application, and accepted the "selective cite-all' option, However, ratherthan catching the inconsistencies, the Agency noted the checked box and accepted the "selective cite-all" option and moved on with a R330 classification. We now come to realize that all ofwork thatwent into the resubmission ofa new data matrix and label restricting the use-sites in August 2010 and all ofthe work to establish R310 classification could have been avoided had someone on the classification committee orthe Front End Screen noticed the discrepancies and made a phone call to the submitterfor clarification, It is ourfirm contention that based on the unique circumstances discussed above, where the original submission and fee are consistent 

### with a "cite all" application, afair and equitable resolution ofthis matterwould provide that on submission of a new Certification with respect to data Citation (EPA Form 8570- 34) the Agency should be able to complete 

## ITs review in a timely manner under the R310 classification as originally requested. There is at least one analogous case where a technical fipronil application with a much broader label was classified as R310 and sowe can only surmise that the clerical error on the data certification box is the reaSOn forthe classification error. And to be clear, Fipronext still agrees to the restricted use as stated in the September26 e-mail. The PRIA approval date for a R310 application submitted on May 21, 2010would 

## be in about December 16, 2010. ConSidering the simpliCity 

## ofthe clerical error by the submitter, compounded by the Agency error in not identifying the inconSistency in the screening process and the resulting confusion over classification Fipronextwould be willing to accept January 14, 2011 as afirm PRIA datefor the approval this registration. Sineerely, 'WASHINGTON 1150 18th Sne

....t, NoW. Suite 1000 Washington, D.C. 20036 Telephone 202 223-4392 Fax 202 872-0745

SACRAMENTO 712 Fifth Str

........t Suile A Davis, CA 95616 Telephone 530 757-1298 Fax 530 757-1299

CANADA 275 Sieler Street Suite 900 ottawa, Ontario Kl P SH9 Telephone 613 247-6285 Fax 613 236-3754

E-mail tsg@tsgusa.com http://www.tsgusa.com 

## TECHNOlOGY' SCIENCES 

# GROU' INC

Richard Gebken August 19, 2010 Insecticide Branch Registration Division (7504P) Office of Pesticide Products U.S, Environmental Protection Agency Room**S~4900,** 

### One Potomac Yard 2777 South Crystal Drive Arlington, 

### VA 22202-4501
RE: 

### Fipronil Technical (87650-R) 

### Submission of a revised labeling and data matrix Dear Mr. Gebken: Technology Sciences Group, Inc., on behalf of Fipronext Solutions, Inc., is submitting the enclosed data matrix and labeling to limit the uses and to change this**applicatio~.~()** 

### a**"cit~~all"** 

### to move this into**t~::!.~!~-.2.~te~ry** 

# £l91D..-

- c.. •••**~** 

### You will find to support of this pending application: 1) Application for pesticide registration, 2) Revised certification with respect to citation of data, 3) Revised data matrices (confidential and an**non~confidential** 

### version), and 4) Revised version ofthe proposed label (5 copies). Please do not hesitate to contact me directlywith any questions. Sincerely,

# ~Q £')6'--- Heather R. Bjornson Regulatory Consultant to Fipronext Solutions, Inc. Direct dial: (202) 828-8945**e~mail:** 

### hbjornson@tsgusa.comWASHtNGTON 1150 18th Street, N.w. Suite 1000 Washington, D.C. 20036 Telephone 202223-4392 Fax 202 872-0745

SACRAMENTO 712 Fifth Street Suite A Davis, CA 95616 Telephone 530 757·t298 Fax 530 757·1299

CANADA 275 Slater Street Suite 900 Ottawa, Ontario KtP5H9 Telephone 613 247·6285 Fax 613 236·3754

E·mail tsg@tsgusa.(Om http://WWW.tsgusa.com 

### Richard Gebken Insecticide Branch Registration Division (7504P) Office of Pesticide Products U.S. Environmen1al Protection Agency Room 8-4900, One Potomac Yard 2777 South Crystal Drive Arlington, VA 22202-4501 May 21,2010

RE: Application to Register 

### Fipronil Technical (87650-R) PRIA Category R 310
- New product, Non-fasttrack
Dear Mr. Gebken: 

# l[CHNOlOG¥ SCI[NC[S

GROUr INC

Technology Sciences Group, Inc., on behalf of Fipronext Solutions, Inc., is submitting the enclosed application to register Fipronil Technical (98.5% Fipronil). Included in this application for registration is the complete product chemistry data as well as a bridging argumentfor bridging the toxicity data that has been previously submitted to the Agency for similar products. The remaining data requirements are being satisfied with the "cite-all" method. You will find the following in support ofthis application: 1) Application for pesticide registration, 2) Confidential statement offormula, 3) Certification·with respect to cita1ion of data, 4) Data matrices (confidential and an non-confidential version), 5) Five copies ofthe proposed label, 6) Volumes 1
- 6 (referto the 1ransmittal documentfor specific information on each data volume), 7) Small business waiver application and supporting documentation, and 8) PRIA pre-payment receipt: Pay.gov tracking 10: 

### 250S70L8; Agency tracking 10: 

### 74117800617. Please do not hesitateto contact me directlywith any questions. Sincerely, 

# lzfJ004i<**(!,~** Heather 

### R. Bjornson Regulatory Consultantto Fipronex1 Solutions, Inc. Direct dial: (202) 828-8945 e-mail: hbjornson@tsgusa.com

### VOLUME 1 OF 6 OF SUBMISSION TRANSMITTAL DOCUMENT NAME AND ADDRESS OF SUBMITTER: Fipronext Solutions, Inc. 

### 3259 Harvey Court Pleasanton, CA 94588


### REGULATORY ACTION: 

### 481040.00

PRIA Category R 310 - Application to register 

### FipronH **Technical (87650-R).** 


### TRANSMITTAL DATE: May 21,2010 

### LIST OF SUBMITTED STUDIES: MRID VOLUME NUMBER NUMBER EPA STUDY TITLE 10f6 

### 48104001 2 of6


### 48104002 3 of

### 6


### 48104003 4 of

### 6



### 48104004 5 of 

### 6


### 48104005 6 of 

### 6

COMPANY NAME: (Transmittal Document) 

### Fipronil **T echnica/**  Product Chemistry - PartA 

### Fiproni! **Technical** Product Chemistry - Part B 

### Fipronil **Tech nica!**  Physical Properties 

### Fipronil **Technical** Prelim'lnary Analysis 

### Fipronil **Technical** Toxicity Bridging Discussion Fipronext Solutions, Inc.

Page 1 of 2 

### GUIDELINE NUMBER

830.1000
- 830.1900

830.6302
- 830.7950 830.6313, 830.7000 830.7050
830.1700
870.1100
- 870.4300

### COMPANY OFFICIAL:
COMPANY CONTACT: 

### Heather 

### R. Bjornson, Rel(ulatory

### Agarr Heather R Bjomson, Regulatory Agent 

### Technology Sciences Group, Inc. 1150 18th Street, NW. Ste.1000 Washington, DC 20036 (202) 828-8945

Page 2 012

# FIPRONIL TECHNICAL For Manufacturing Use Only

ACTIVE INGREDIENT: F ipron

### iI: 5-amino-1-(2,6-dichloro-4-(trifluoromethyl) phenyI)-4-((1 ,R,S)-trifluorom8th

### yI)sulfinyI) -1-H-pyrazole-3-carbonitrile

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

### .......................... 98.0% INERT INGREDIENTS

....... .............. 2.0% TOTAL

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

### ....... 100.0%


## KEEP OUT OF REACH OF CHILDREN 

# WARNING
Si usted no entiende 

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### la explique a usted en detalle. (If you do not understand this label, find someone to explain 

### it to you.)



### EPA Reg. No.: 87650-R EPA Est. No.: XXXXX-XXX-XXX Net Contents:



### Manufactured 

### for: Fironext Solutions, Inc. 3259 Harvey Court Pleasanton, CA 94588 -'; 

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### FIRST AID IF SWALLOWED Immediately cal! poison control center or doctorfor treatment advice. Do not induce vomiting unless told to do so by a poison control center or doctor. 

### Have person sip a glass ofwater if

### able to swallow. Do not aive an thi ng bv mouth to an unconscious person. 

### IF ON SKIN OR Take off contaminated clothing. 

### CLOTHING Rinse skin immediately with plenty ofwater for 15-20 minutes. 

### Cal! a poison control center or doctor for treatment advice. IF INHALED Move person to fresh air. If 

### person is not breathi ng, call 911 or an ambulance, then give 

### artificial respiration, preferably by 

### mouth-to-mouth 

### if possible. Call a poison control center or doctorfor further treatment advice. 

### IF IN EYES Hold eye open and rinse slowly and gently with water for 15-20 minutes. Remove contact lenses, if present, after the first 5 minutes, then continue rinsing. Call a poison control center or doctorfor treatment advice. 

### HOT

### Llt-IeJII~~\lER Have the product container or label with you when**caI.f1n9t~RQi~on** 

### control center or doctor, or

### ~oing**fo~** treatment. You may also contact 1-800-334-7577

### fOr.emf1!~eg9Y, medical treatment mformatlon. 1'

..1;;1J:1; 

### G 

### NOTE TO PHYSICIAN:

..

## ~~! There is no specific antidote. All treatment should be based on observed signs and symptons of 

# i distress in the patient. Overexposure to materials other than this product may have occurred. 

### PRECAUTIONARY STATEMENTS HAZARD TO HUMANS AND DOMESTIC ANIMAlS- WARNING: May be fatal if swallowed, absorbed through the skin or inhaled. Causes substantial but temporary eye injury. Do not get in eyes, on skin, or on clothing. Wear goggles, face shield, or safety glasses. Wash thoroughly with soap and water after handling and before eati ng, drinking, or using tobacco. Wear protective clothing and rubber gloves. Remove contaminated clothing and wash clothing before reuse. Do not breathe dust. Wear a dust/mist filtering respirator (MSHAINIOSH approval number prefix TC-21 C), or a NIOSH approved respirator with any N, R, 

### P or HE filter. SYMPTOMS OF POISONING: In severe cases of overexposure by oral ingestion, lethargy, muscle tremors, and, in extreme cases, possibly convulsions, may occur. 

### ENVIRONMENTAL HAZARDS This product is toxic to birds, fish, estuarine and aquatic invertebrates. Do not discharge effluent containing this product into lakes, streams, ponds, estuaries, oceans, or other waters unless in accordance with the requirements of a National Pol! utant Discharge Elimination System (NPDES) permit and the permitting authority has been notified in writing prior to discharge. Do not discharge effluent containing this product to sewer systems without previously notifying the local sewage treatment plant authority. For guidance, contact your State Water Board or Regional Office ofthe EPA.

Fipronil Technical label version (1) dated August 19, 2010 Page 2 of4

### DIRECTIONS FOR USE It is a violation of law to use this product in a manner inconsistent with its labeling. Read entire label before using this product. Only for formulation into insecticide products. Formulators using this product are responsible for obtaining EPA registration for their formulated 

### product which may be labeled for use patterns as found listed on this label. Only for formulation into products for the following uses: • Domestic Indoor (household, etc.) 

### Not for use to formulate products for termite control or liquid sprayable formulations for the above cited use sites. 

### STORAGE AND DISPOSAL Do not contaminate water, food, or feed by storage or disposal. 

### PESTICIDE STORAGE 

## (J:i.JJ T'"'**~~** 

### Store unused product in original container only,

### ofkS?retiel'i'2p.f~jJdJ:en and animals

. .• . _J) 

## ";!BEl:**oa~** 

### PESTICIDE DISPOSAL .•., Pesticide wastes are acutely hazardous. Improper disposal of excess pesticide is a violation of Federal law. Ifthese wastes cannot be disposed of by use according to label instructions, contact your State Pesticide or Environment Control Agency, or the Hazardous Waste representative at the nearest EPA Regional Office for guidance. In case of spill, clean up spillage using shovels and avoiding s kin contact. Carefully scoop up loose mater"lal and place it in appropriate containers so as to avoid dust generation. Decontaminate tools and equipment following cleanup. In case of large scale spillage in the U.S. regarding this product, call 1-800-334-7577. 

### CONTAINER DISPOSAL Nonrefillable container. Do not reuse or refill this container. Completely empty bag into manufacturing equipment. Then dispose of em pty bag in a sanitary landfill or, ifallowed by government regulations, by burn'lng or incineration. If bag is burned, stay out of smoke.



### IMPORTANT: READ BEFORE USE Read the entire Directions for Use, Disclaimer ofWarranties and Limitations of Liability before using this product. Ifterms are not acceptable, return the unopened product container at once. By using this product, user or buyer accepts the following Disciaimer ofWarranties and Limitations of Liability.

Flpronil Technical label version (1) 

### dated August 19, 2010 

### Page 3 

### of4

### DISCLAIMER OF WARRANTIES: TO THE EXTENT CONSISTENT WITH APPLICABLE LAW, FIPRONEXT SOLUTIONS, INC, MAKES NO OTHER WARRANTIES, EXPRESS OR IMPLIED, OF MERCHANTABILITY OR OF FITNESS FOR A PARTICULAR PURPOSE OR OTHERWISE, THAT EXTEND BEYOND THE STATEMENTS MADE ON THIS LABEL. No agent of Fipronext 

### Solutions, Inc. is authorized to make any warranties beyond those contained herein or to modify the warranties contained herein. TO THE EXTENT CONSISTENT WITH APPLICABLE LAW, 

### FIPRONEXT SOLUTIONS, INC, DISCLAIMS ANY LIABILITY WHATSOEVER FOR SPECIAL INCIDENTAL OR CONSEQUENTIAL DAMAGES RESULTING FROM THE USE OR HANDLING OF THIS PRODUCT. LIMITATIONS OF LIABILITY: TO THE EXTENT CONSISTENT WITH APPLICABLE LAW THE EXCLUSIVE REMEDY OF THE USER OR BUYER FOR ANY AND ALL LOSSES, INJURIES OR DAMAGES RESULTING FROM THE USE OR HANDLING OF THIS PRODUCT. WHETHER IN CONTRACT, WARRANTY, TORT, NEGLIGENCE, STRICT LIABILITY OR OTHERWISE, SHALL NOT EXCEED THE PURCHASE PRICE PAID, OR AT FIPRONEXT SOLUTIONS, INC. ELECTION, THE REPLACEMENT OF PRODUCT.

Batch Code:

Fipronil Technical label version (1) dated August 19, 2010 Page 4 of4

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



### November 8, 20I0

OPP DecisionNwnber: D-434093 EPAFile Symbol or RegistrationNnmber: 87650-R ProductName: FIPRONIL TECHNICAL EPA ReceiptDate: 24-May-2010 EPA CompanyNwnber: 87650 Company Name: FIPRONEX SOLUTIONS, INC HEATHER BJORNSON TECHNOLOGY SCIENCES GROUP, INC FIPRONEX SOLUTIONS, INC 1150 18TH STREET, NW SUITE 1000 WASHINGTON, DC 20036- OFFICE OF PREVENTION, PESTICIDES AND TOXICSUBSTANCES



### SUBJECT: Receipt ofRegistrationApplication Subject to Registration ServiceFee Dear Registrant: The Office ofPesticide Programs has receivedyour application and certification of payment. 

## Ifyou submitted data 

### withthis application, the results ofthe PRN-86-5 screen will be communicated separately. During the administrative screen, the Office ofPesticide Programs has determined thatthis Actionis subjectto a Pesticide Registration Service Fee as defined 

### in the Pesticide Registration ImprovementAct. The Action previously identified as R330 has been reclassified as Action Code: R310 NEW PRODUCT;NON-FAST TRACK (INCLUDES REVIEWS OF PRODUCT CHEMISTRY;ACUTE TOXICITY;PUBLIC HEALTH PESTEFFICACY); The fee associatedwith this action is $ 1,145. Payment inthe amount of$4,284 has been received. A refund inthe amount of$ 3,139 will be issued when the action is completed. Ifyouhave any questions, please contactthe Pesticide Registration Service Fee Ombudsman at (703) 308-9362.• •••¥ .....O •••• 

# 0· <\6)-**.~.** 

### Re: Fw: Change of PRIA classification from R330 to R310 for Fipronext Solutions Inc., Fipronil Technical 087550-RJ 

## IJi 

# • 

# ............... Stephen Schaible to: Bonaventure Akinlosotu, Richard Gebken 11/08/201009:40 AM Cc: kenny.dan, Marion Johnson, John Jamula
Sorry- I thought that deciding on the negotiated date (orthe need to negotiate the date) was a precursor to flipping the code. I am cc:ing JJ, to go ahead and recode the action. 

### Steve (308-9362) 87650-R (typo in subject line of email thread) 0434093 recode from R330 to R31 0

Bonaventure Akinlosotu PIs keep me informed on any updates on t... From: To: Bonaventure Akinlosotu/DC/USEPAfUS Richard Gebken/DC/USEPAfUS@EPA 11/08/201006:56:13AM



### Ceo Stephen Schaible/DC/USEPAfUS@EPA, Marion JohnsontDC/USEPAfUS@EPA, kenny.dan@epa.gov Date: Subject: 11/08{201006:56AM Re: Fw: Change of PRIA classification from R330 to R310 for Fipronext Solutions Inc., Fipronil Technical087550-Rj

PIs keep me informed on any updates on this, I spoke with Heather on Friday and the registrant is waiting anxiously for updates. Thx. -----Richard Gebken/OC/USEPAfUS wrote:
----- To: Stephen Schaible/DC/USEPAlUS@EPA From: Richard Gebken/DC/USEPAlUS 

### Date: 11/05/2010 

### 01 :40PM Cc: Bonaventure Akinlosotu/DC/USEPAfUS@EPA, Marion Johnson/DC/USEPAlUS@EPA, kenny.dan@epa.gov Subject: Re: Fw: Change of PRIA classification from R330 to R31 0 for Fipronext Solutions Inc., Fipronil Technical 087550-RJ Stephen, Can you forward yourinformat'ron to John Jamula, so he can flip the code to an R310? I've checked today, and it has still to be done. Until this change is made in the system, BA cannotsend BEANS to TRB for review. BAwill need to renegotiate based on the changed PRIA codes/dates. Thanks, Richard Stephen Schaible---1 0/26/2010 11 :50:23 AM---Elizabeth and Marty, Here is the response Igave back to the Fipronex agent yesterday. I metwith 

### From: Stephen SchaiblelDCruSEPAlUSTo: Elizabeth Leovey/DCIUSEPAfUS@EPA Cc: Marty Monell/DCIUSEPAfUS@EPA, Richard GebkeniDCIUSEPAIUS@EPA, Marion Johnson/DCIUSEPAIUS@EPA Date: 10126/2010 11:50 AM SubjectFw: Change ofPRIA classification from R330 to R31 0 for Fipronext Solutions Inc., Fipronil Technical 087550-R]

Elizabeth and Marty, Here is the response I gave back to the Fipronex agent yesterday. I metwith IB lastweek and therewas agreementthat we could classify this backto the R31 0 that It originally came in under. A woman from TSG contacted me this morning to follow up on the negotiated date comment below, and I forwarded her tothe PM. It looks like I have committed myselfto a follow-up letterin my email below, and will cc: you on that. Regards, Steve Stephen A. Schaible U.S. Environmental Protection Agency Office of Pesticide Programs Registration Division (7505P) 1200 Pennsylvania Avenue, NW Washington, DC 20460 

### ph: (703)308-9362 fax: 

### (703)305-6920

___ MM Forwarded by Stephen Schaible/DC/USEPAIUS on 10/26/2010 11 :43 AM __ MMM From: Stephen SchaiblelDCIUSEPAfUS To: "Robert Stewart" <RStewart@TSGUSA.COM> Cc: lain Weatherston <IWeatherston@TSGUSA.COM>,Marion Johnson/DClUSEPAfUS@EPA,Richard Gebken/DCIUSEPAfUS@EPA Date: 10/25/20ID 04:35 PM SubjecRE: Change ofPRIA classification from R330 to R3ID for Fipronext Solutions Inc., Fipronil Technical 087550-Rj 

### t:

Hi Bob, The Insecticides Branch and I met on this last week and are in agreement that this action can be coded as an R310 (despite Form 8670-34 being filled out incorrectly, which led to the reclassification to R330). Wewi!! be responding to lain's letter dated 10/7/10 and will provide greater detail in that response. It is my understanding that 18 has been in contactwith lain and thatTSG and its client are willing to negotiate the PRIA date out further should this be necessary to accommodate completion ofthe review. Ifyou have anyfurther questions about this action, please contactthe PM, Richard Gebken, at 

### (703)305-6701. Regards, Steve Stephen A. Schaible, Acting PRIA Ombudsman Registration Division Office of Pesticide Programs, U.S. EPA(703)308-9362 schaible.stephen@epa.gov
"Robert Stewart" ---10/25/2010 03:57:13 PM---Hi Stephen, From: "Robert Stewart" <RStewart@TSGUSA.COM> 

### To: Stephen SchaibleIDCIUSEPAlUS@EPA Date: 10/25/201003:57 PM SubjectRE: Change ofPRlA classification from R330 to R310 for Fipronext Solutions Inc., Fipronil Technical 087550-RJ



### Hi Stephen, I am just following up on lain's e-mail below. Has there been any progress on the PRIA code 

### change? Bob 

### Robert Stewart, Ph.D. Vice President, Technology Sciences Group Inc.

202-828-8963 rstewart@TSGU5A.COM 

### http://www.tsgusa.com

From: 

### lain Weatherston Sent: Friday, October 22, 2010 4:53 PM 

### To: schaible.stephen@epa.goY Cc: Robert Stewart; Abramson, Stanley 

### Subject: fIN: 

### Change of PRIA classification from R330 to R310 for Fipronext SolUtions Inc., Fipronil Technical**087SS0~R)** 

### Dear Stephen: Following our conversation last Monday, about a response to the issue ofthe Fipronext Solutions PRIA category which we would like assigned as R310 and not R330 I am writingto let you knowthat I will be out ofthe country until November 2. In my absence, and since the client is expecting a response before I return would you please communicate the decision to mycolleague Bob Stewart ( rstewart@tsgusa.com )with a copy to me for continuity. Thanks, lain

### From: lain Weatherston Sent: Thursday, October 07, 2010 12:02 PM To: 'schaible,stephen@epa.gov' Cc: 'monell.marty@epa,gov'; 'Isbell,Diane@epa,gov'; 'johnson.marion@epa,gov' Subject: Change ofPRIA classification from R330 to 

### R310 for Fipronext Solutions Inc" Fipronil Technical**087550~R]** 

### Stephen: Please find attached a letter on behalfofFipronext Solutions Inc., with background information and a further request to have the PRIA category changed from R330 to the originally requested R310. Also, below as stated in the letteris a copyofthe September26,**e~mail** 

### to Richard Gebken. Icopy ofthis letterand**e~mail** 

### is also being senttothe Agency and will arrive there tomorrow morning. Iwish to certifythat the electronicversions ofthese documents and the hard copies are identical. Regards, lain Weatherston "Richard: With a five hourflight backto Phoenix, Ihad plenty oftime to think about the discussions on the R310, R339 issues between the client and the EPA. Much ofthe discussion and what was said really did'not make any senseto me and Ieventually cameto the conclusion that you and Iwere actually not on the same page. On Friday morning Ichecked with Bob Stewartin ourDC office and asked him which box was ticked on the Certification with respect to citation ofdata (EPA Form 8570-34) when the application was submitted in May. In the application the box which was ticked was the beside the text "I am using the elective method ofsupport (or**cite~all** 

### option under the selective method) and have included with th'ls form a completed !'ist of data requirements (the data Matrix form must be used," Ibelieve that this was done in errorsince Fipronext intended to use the**cite~all** 

### method of support and they did include a list ofcompanies sent offers ofcompensation by attachingthe names and addresses ofthe contacted companies by appendingthe relevant portion ofthe most recent DSl tothe data matrix, Also review ofthe Pesticide Registration Manual (2010 iteration ofthe "Blue Book") defines the methods ofcomplying with the data compensation requirements ofFIFRA 3{c)(1){F) as: Cite-All: The applicant cites all the data in the Agency files that are pertinentto EPA's consideration ofthe requested registration action. This is further clarified on page 5 of Chapter 10ofthe manual by sayingthat applicants may complywith this data compensation requirement By "citing all pertinent data in the Agencies files and making appropriate offers to pay compensation," Selective Method: The applicant lists the specific data requirements that may apply to its product, its active ingredients and the use patterns and then selectively cites to (the) individual studies, including the applicants own data. The selective method also allows an

### applicant to**"cite~all"** 

### data in the Agency's files to satisfy specific data requirements (commonly referred to as "selective**cite~all").** 

### So this leads me to ask you two questions. 1] Regarding Fipronext application, they supplied product chemistry and a bridging rationale for acute toxicity which is noted in the data matrix, and then intended to use the "cite-all" option which does not need a list ofdata requirement guideline numbers in the data matrix but only a list ofthe companies sent offerto pay letters. My understandingthat this was done. The application was submitted as R310 which was invalidated by the ticking oOfthe wrong box since selective citation (includi9ng selective cite-all) would require the Agency to go outside of Registration Division to determine ifthe guideline cited satisfied the requirements based on the uses stated on the label. However, since the applicant paid only the fee for a R310, did not list the guideline numbers on the data matrix, possibly Front End should have asked them for clarification. At the meeting you indicated that Fipronext should re-file a complete data matrix and possible narrowthe scope ofthe uses to which the technical material may be put, e.g. "For use only in the formulation ofectoparasitcide products for use on companion animals." Ibelieve thatthis should still be done however EPA Form**8570~34** 

### should also be resubmitted signifying the use ofthe cite-all option (this would negate having to list all ofthe guideline number) and an updated draft label. Then we would be in a position to pursue a formal reassessment from R330 to R310. 2] It is most probable that within the next 6 weeks Iwill wish to come into the Agency with an application to register a 98% or greatertechnical flpronil. The applicant ofthis material will wish to have the application classified as R310 and wishes to supply his own product chemistry package and use the "cite-all" method for all otherdata requirements. Iwould like your concurrence that provide the "cite all" box is ticked on Form**8570~34** 

### such an application will be classified as R310. Regards, lain

### Data requirements for Fipronil indoor uses (e.g., Fipronex's 87650-R) Bonaventure Akinlosotu to: Stephen Schaible 

### 10/13/201012:49 PM Cc: Richard Gebken, Marion Johnson FYI: Contrarily to the revised data matrix submitted by Fipronex, below is the list ofdata that needs to be reference, and address oneway oranother for the proposed "complete indoor residential use pattern" (as stated on the proposed product's label): 

### Data requirements for Fipronil indoor uses 830.1550 J Product Identity and Composition 

# I ? 830.1600J Description of Materials Used to Produce Product j

I 

### -830.1620 Description of Production Process \--. " \ -.'i 

### >. t, 

### 830.1650

### J j Description of Formulation Process / ';\' r::,(\,.iJ.;;', 

### (J'N. 830.1670 Discussion of Formation of Impurities ",' 

### 830.1700;.// Preliminary Analysis 

### 830.1750'i Certified Limits 

### 830.1800./ EnforcementAnalytical Method 

### 830.6302 Color 

### 830.6303,) Physical State 

### 830.6304./ Odor 830.631 Stability to Normal and Elevated Temperatures,Metals, and Metal Ions 

### 830.6314 Oxidation/Reduction: Chemical Incompatibility 

### 830.6315 Flammability 

### 830.6316 Explodability 

### 830.6317 Storage Stability 

### 830.6319 Miscibility 

### 830.6320 Corrosion Characteristics



### 30.6321

# J. Dielectric Breakdown Voltage 

### 830.7000 pH 830.7050

# J -J' UVNisibleAbsorption 

### 830.7100 Viscosity 

### 830.7200 

### -.t, Melting Point/Melting Range 

### 830.7220.).; Boiling Point/Boiling Range 

### 830.7300! DensitylRelative Density/Bulk Density**~** Dissociation Constants in Water 

### 830.7520 Particle Size, Fiber Length, and Diameter Distribution

### 830.7550~ Partition Coefficient (n-octanol/water), Shake Flask Method 

### ( 1830.7560\ Partition Coefficient (n-octanol/water), Generator Column Method 

### 830.7570) Partition Coefficient (n-octanollwater), Estimation by Liquid Chromatography 

### 830.7840'/ Water Solubility: Column Elution Method; Shake Flask Method 

### (830.7860) J Water Solubility, Generator Column Method 

### 830.7950..J' Vapor Pressure 

### 870.1100./ 

### 870.1200j 870.1300./ 870.2400./ 870.2500' / 870.2600 V Acute Oral Toxicity: Rat Acute Dermal Toxicity: Rat Acute Inhalation Toxicity: Rat Primary Eye Irritation: Rabbit Primary Dermal Irritation Dermal Sensitization 

# ,I**~**

')

_ 850.2100**(71~**

### 1(a)) Acute Avian Oral Toxicity: Quail or Duck



## ,

### (:850.1075 

### -; 850.1075 '0 

### L.850.1010 

### 870.6200 .; 870.3100 870.3150 870.3200 870.3250 870.3465 870.6100

# j 870.6200 870.4100 870.4100 870.4200 870.4200 870.3700 870.3800 870.6300 870.51001, 870.5300:/ 870.5385 870.7200/ 870.748si' 870.7600) 870.7800 875.1100 875.1200 875.1300 875.1400 875.1500 875.1600 875.1700 875.2100 875.2200 875.2300 875.2400 875.2500 835.2120 (72-1 (a),(b» Fish Toxicity: Bluegill (72-1(c),(d)) Fish Toxicity: Trout (72-2(a)(b» Freshwater Invertebrate Toxicity (81·S) Acute Neurotoxicity (Rat) (82-1

### (a» 90-Day Oral Toxicity in Rodents (82-1(b» 90-Day Oral Toxicity in Non·Rodents (82-2) 21-0ay Dermal Toxicity (82-3) 90-Day Dermal Toxicity (82-4) 90-Day Inhalation Tox"rcity 28-0ay Delayed Neurotoxicity
- Hen 90-Day Subchronic Neurotoxicity -Rat (83-1(a» Chronic Toxicity Rat (83-1 (b» ChronicToxicity Dog (83-2(a)) Carcinogenicity Rat (83-2(b» Carcinogenicity Mouse (83-3) Prenatal Development Toxicity Studies (83-4) Reproduction and Fertility Effects (83-6) Developmental Neurotoxicity Study (84-2(a)) Bacterial Reverse Mutation Test 870.5375 (84-2(b) In vitro Mammalian Cell Gene Mutation 870.5395 (84-4) In vivo Cytogenetics Companion Animal Safety Metabolism and Pharmacokinetics (85-2) Dermal Penetration Immunotoxicity Dermal Outdoor Exposure Dermal Indoor Exposure Inhalation Outdoor Exposure Inhalation Indoor Exposure Biological Monitoring Data Reporting and Calculations Product Use Information (132-1a) Foliar Residue Dissipation Soil Residue Dissipation IndoorSuliace Residue Dissipation (133-3) Dermal Passive DOSimetry Exposure (133-4) Inhalation Passive Dosimetry Exposure (161-1) Hydrolysis 860 series Residue Chemistry Data requirements

# ....**~**

# .."**.~G). .~.**  

# • .6I.U", ..... .bAM. 

### Fw: Change of PRIA classification from R330 to R310 for Fipronext Solutions Inc., Fipronil Technical 087550-RJ Stephen Schaible to: Bonaventure AkinJosotu, Richard Gebken 10/13/201012:49 PM Cc: Elizabeth Leavey, Marion Johnson, Rachel Holloman**~--~ ~-**  

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

## ..-.-. 

### SAlRichard, Below is the email and letter that I received last Thursday afternoon. Because Martywas cc:'d Jwill need to send her an email laying out the situation. Can you please provide me a time-line ofthe communications that occurred with this individual? From what BA described to me this morning, considerable effort has gone into getting the label and data matrix corrected such thatthis could be considered an R31 0 rather than an R330. Can you please layoutthe issues/deficiencieswith the label/data matrix/etc. which prevented us from considering this a R310?

. Thanks! Steve (308-9362)

----- FOlwarded by Stephen Schaible/DC/USEPAIUS on to/13/2010 12:35 PM
----

From: To: Cc: Date: SUbject

Stephen: "lain Weatherston" <IWeatherston@TSGUSA.COM> Stephen Schaible/DC/USEPA/US@EPA Marty Monell/DC/USEPA/US@EPA, Diane Isbell/DC/USEPAlUS@EPA, Marion Johnson/DC/USEPA/US@EPA 10107/201002:02 PM Change of PRIA classification from R330 to R310 for Fipronext Solutions Inc., Fipronil Technical 087550-R]

Please find attached a letter on behalf of Fipronext Solutions Inc., with background information and a further request to have the PRIA category changed from R330 to the originally requested R310. Also, below as stated in the letter is a copy ofthe September 26, e-mail to Richard Gebken. I copy ofthis letter and e-mail is also being sent to the Agency and will arrive there tomorrow morning. I wish to certify that the electronic versions ofthese documents and the hard copies are identical. Regards, lain Weatherston "Richard: With a five hourflight back to Phoenix, I had plenty oftime to think aboutthe discussions.on the R310, R339 issues between the client and the EPA. Much ofthe discussion and what was said really did not make any sense to me and I eventually came to the conclusion that you and I were actually not on the same page. On Friday morning I checked with Bob Stewart in our DC office and asked him which box was ticked on the Certification with respect to citation of data (EPA Form 8570-34) when the application was submitted in May. In the application the box which was ticked was the beside the text "I am using the elective method of support (or !=ite-all option under the selective method) and have included with this form a completed Jist ofdata requirements (the data Matrixform must be used." I believe that this was done in error since Fipronext intended to use the cite-all method of support and they did include a list of companies sent offers of compensation by attaching the names and addresses ofthe contacted companies by appending the relevant portion of the most recent DSL to the data matrix.

### Also review ofthe Pesticide Registration Manual (2010 iteration ofthe "Blue Book") defines the methods ofcomplying with the data compensation requirements of FIFRA 3(c){1){F) as: Cite-AU: The applicant cites all the data in theAgency files that are pertinentto EPA's consideration of the requested registration action. This is further clarified on page 5 ofChapter 10ofthe manual by saying that applicants may comply with this data compensaffon requirement By "citing all pertinent data in theAgencies files and making appropriate offers to pay compensation." Selective Method:The applicant lists the specific data requirements that may apply to its product, its active ingredients and the use patterns and then selectively citesto (the) individual studies, including the applicants own data. The selective method also allows an applicant to "cite-aU" data in the Agency's files to satisfy specific data requirements (commonly referred to as "selective cite-all"). So this leads meto ask you twoquestions. 1] Regarding Fipronext application, they supplied product chemistry and a bridging rationale for acute toxicity which is noted in the data matrix, and then intended to use the "cite-all" option which does not need a list ofdata requirementguideline numbers in the data matrix but only a list ofthe companies sentofferto pay letters. My understanding that this was done. The application was submitted as R310 which was invalidated by the ticking oOfthe wrong box since selective citation ('rncludi9ng selective cite-all) would require the Agency togo outside of Registration Division to determine ifthe gUideline cited satisfied the requirements based on the uses stated on the label. However, since the applicant paid only thefee for a R310, did notJist the guideline numbers on the data matrix, possibly Front End should have asked them for clarification. At the meeting you indicated that Fipronext should re-file a complete data matrix and possible narrow the scope ofthe uses to which thetechnical material may be put, e.g. "For use onlyin the formulation ofectoparasitcide products for use on companion animals." Ibelieve thatthis should still be done however EPA Form 8570-34 should also be resubmitted signifying the use ofthe cite-all option (this would negate having to list all oftheguideline number) and an updated draft label. Then we would be in a pOSition to pursue a formal reassessmentfrom R330 to R310. 

### 2) It is most probablethatwithin the next 6 weeks IwiU wish to come into theAgency with an application to register a 98% orgreatertechnical fipronil. The applicant ofthis material will wish to have the application classified as R310 and wishes to supply his own product chemistry package and use the "cite-all" method for all otherdata requirements. Iwould like yourconcurrence that provide the "cite all" box is ticked on Form 8S70-34 such an application will be classified as R310. Regards, lain"

# ~

LeUer to Stephen Schaible 002.tifTechnology Sciences Group Inc. Western Division 4061 North 1561/"1 Drive Goodyear, AZ 85338 Phone: (623) 535-4060**E~Mail:** iwea1hers1on@tsgusa.com**"~~** .-..-- .- .-;;;/**~** -4ain-Weatherston. Ph.D. ( Senior Managing Consultant \

### ~//



# " /**~-~....** 

### ,,-

Stephen Stabile Registration /PRIA Ombudsperson U,S, EPA-OPP-RD One PotomacYard 2777 South Crystal Drive Arlington VA22202 October 7, 2010

SUBJECT: Change ofPRIA classification from R330 to R310. COMPANY: Fipronext Solutions Inc, 3259, Harvey Court, Pleasanton, CA 94588, CONTACT: lain Weatherston, Ph.D., Technology Sciences Group Inc. [Contact information as per letterhead] PRODUCT: Fipronil Technical**[87550~R]** 

### Dear Mr. Schaible: As agent for, and on behalfof Fipronext Solutions Inc., I am writing to you following receipt ofan**e~mail** 

### from Bonaventure Akinlosotu indicating that Team #10 has asked you to consult on the request of Fipronext to havethe PRIA category oftheir application to register Fipronil Technical [87550·R] changed back from R330 to Originally submitted R310. Given the critical nature 

## ofthis application to Fipronext I am sending you this background information sothat all facts surrounding this application are available. To that end I have also attached a copy ofthe September26**e~mail** 

### to Richard Gebken, where the applicant in an attemptand negotiation to secure a R310 classification agreed to restrict the label to denote a single use and offered to resubmit a corrected EPA Form 8570·34, The Fipronext application was submitted on May 21,2010, in the cover letterthe submitter indicated (correctly) that the desired PRIA category was R31 0 and included both the Pay.gov and the Agencytracking ID's indicating that R310 PRIAfee had been prepaid. That paymentwas accepted without question. Data Matrices submitted were appropriate to the R310 designation for the use of"cite all" as the method forsatisfying the data requirements. TheAgency on review ofthe application decided to reclassifyStephen Schaibl& Flpronext Solutlons Inc., letterofOctober7, 2010 Page 2.


### the application as R330. The submitter challenged this, however the communications with Linda Arrington were conducted overthe telephone and the reasons forthe reclassification were not clear. Itwas not until after my meeting with Richard Gebken and BAon September23 that the reason became clear
- there was a clerical erroron the EPAform 8670-34 where the "selective cite-all" boxwas checked instead ofthe "cite-all" box. Whilethe "wrong box checked" is an admitted administrative error by the submitter, it is importantto notethatthrough the Front End review, which is designed to provide an administrative review ofthe application for completeness and formatting, the Agency ignored or missed that (a) the submitterwas submitting a R310 application [stated in the cover letter and again on the application form (EPA Form 8570-1)], (b) that the R310 fee was paid and accepted and (c) the fact thatthe data matrices were consistent with a cite-all application, and accepted the "selective cite-all" option. However, rather than catching the inconsistencies, the Agency noted the checked box and accepted the "selective cite-all" option and moved on with a R330 classification. We now come to realize that all ofwork that went into the resubmission ofa new data matrix and label restricting the use-sites in August 2010 and all ofthe work to establish R310 classification could have been avoided had someone on the classification 

### committee orthe Front End Screen noticed the discrepancies and made a phone call to the submitterfor clarification. It is ourfirm contention that based on the unique 

### circumstances discussed above, where the original submission and fee are consistent with a "cite all" application, a fair and equitable resolution ofthis matterwould provide that on submission of a new Certification with respect to data Citation (EPA Form 8570- 34) theAgency should be able to complete its review in a timely manner underthe R310 classification as originally requested. There is at least one analogous case where a technical fipronil application with a much broader label was classified as R310 and so we can only surmise thatthe clerical error on the data certification box is the reason forthe classification error. And to be clear, Fipronext still agrees to the restricted use as stated in the September 26 e-mail. The PRIA approval date for a R310 application submitted on May 21, 2010 would be in about December 16, 2010. Considering the simplicity 

## ofthe clerical error by the submitter, compounded by the Agency error in not identifying the inconSistency in the screening process and the resulting confusion over classification Fipronextwould be willing to accept January 14, 2011 as a firm PRIAdate forthe approval this registration. Sincerely,

. )'..lO.M

# W~VUh.-PlIJUIJ ,IJ.rim.trot:tiD Dn ,."venllbllfD,." C<I ,,ill< form. Form AD rovo,- OMB No. 2070-OO8( , '.28·95 Unitod Statas 

# D Registration OPP Idantifiat Numbtt 

# &EPA Environmental Protection Agency Amendment Washington, DC 20460 ,f 

## Other Application for Pesticide
- Section I 1. Company/Product Numbar 2. EPA Ptoduct Monogar 3. Ptoposed Classification 87650-R Richard Gebken

### ~NOn(l 

# o Restricted 4. Compeny/Product INamol 

# PM'

Fipronil Technica! 

### 10 Insecticide Branch 5. Neme and Address of Applicant IInc/udo ZIP CorioJ 6. Expedited Reveiw. In accotdance with FIFAA Section 31cH3) Fipronext Solutions, Inc. Ib)ji!. my product is similar or identical in composition and labeling 

### 3259 Harvey Court to; Pleasanton, 

### CA 94588 EPA Reg. No. 

# D Chock if(his is 0 now sddross Product Name 

### Section
- II 

# 0 Amllndment

- Explain bolow. 

# U Finel printed label9 in repsonse to Agency lettor doted 

# 0 Rosubmi9sion in response to Agency letter dated 

# 0 "Me**Too~** Applicetion. 

# 0 No!ificotion

- Explain balow. 

# 0 Othor

- Exploin balow. Explanation; Use additionol pegels) if nllcossary. IFor soction Iond Section II.) Submission of a revised label (removing uses) and a tevised data malrix 10 make it a "Cire-all" and PRIA Category R3W.



### Section
- III 1. Muerilll Thl. Product WiD Be p"ckllgad In: Child-Rosistant Peckaging Unit Packaging Wator Solublo Pockoging 2. Typa of Containor 

# W Y

" @Y" 

# @ Y., 

# gM". ,f N, ,f N, N, Plaotic**Glas~** 

### * Certification must If**~Yes·** No. per If 'Yes" No. por Popar Unit Peckoging wgt. containar Packaga wgt contoiner Othor {Specifyl be submitted 3. Locetion of Net Contents Information 4. Siza(sl ReteU Container 5. Location of Lobel Directions



## [{j Labol 

# U Conteiner 

# W 6. Mllnner in Which label is Affixed to Product 

# f**~** 

## 1 Lithogr(lph 

# U**Oth~r** Paper**~u(ld** Stenci ed

## Section

- IV I. Contact Point (Comp/oto iloms dirocr/y be/oWfor idantificotion ofindividus/ to bo contBcttld, ifneC(1$SlIry, to procoss this app/ir::Jtkn:J Name Titla Telopho08 No. 't{r:uru:la Area Coda) Heather R. Bjotnson, Technology Sciences Group, Inc. 

### " Regulatory Consul(ant 1202) 828-8945

,**""':"~ ~~**  Certification 6.**9'~0** A8plicotio'n ' Icertify that the statements I hove mad(l on this form and (III attechment!! thareto ate true, eceurat(l end compl(lta.**"'ocl-i~'ed** ' 

## " ;; , , 

### , Iacknowledge that any knowlingllv folsa or misleading stat(lmant moy bo punishoble by fino Ot imprisonment ot
. tStomped) , > both undor epplicable low. . , " 

### " ) , , , " co,

# 2;~ f2QK" 3.ntlo Regulatory Consultant 10 Fiptonext Solutions, Inc.
4. Typed Name 5. Date Hea(her R. Bjomson 

## August 19, 2010

- ..


### - 

## .. 

# - EPA Form 8570·' (Rov. 3 941 PraVlous editIOns ora obsolot(l. Whit. EPA Fi

.. Copy longman y.now Applieant CopyWASH1NGTON 1150 t8th Slreet, N.W. Suite 1000 Washington, D.C. 20036 Telephone 202 223·4392 Fax 202 872·0745

SACRAMENTO 712 Fifth Street Suite A Davis, CA 95616 Telephone 530 757·1298 Fax 530 757·1299

CANADA 275 Slater Street Suite 900 Ottawa, Ontario KtP SH9 Telephone 613 247-6285 Fax 613 236·3754

E·mail tsg@tsgusa.com http://www.tsgusa.com 

## T[CHNOlOGY"**~CI[NC[s** 

## GROUr INC

Richard Gebken August 19, 2010 Insecticide Branch Registration Division (7504P) Office of Pesticide Products U.S. Environmental Protection Agency Room 8-4900, One Potomac Yard 2777 South Crystal Drive Arlington, VA 22202-4501
RE: 

### Fipronil Technical (87650-R) Submission of a revised labeling and data matrix Dear Mr. Gebken: Technology Sciences Group, Inc., on behalf of Fipronext Solutions, Inc., is submitting the enclosed data matrix and labeling to limit the uses and to change this application to a "cite-aU" to move this into the PRIA Category**~.1JL** Cc • . --_ •• - •••• - •..•..•• 

### You will find to support ofthis pending application: 1) Application for pesticide registration, 2) Revised certification with respect to citation of data, 3) Revised data matrices (confidential and an non-confidential version), and 4) Revised version of the proposed label (5 copies). Please do not hesitate to contact me directly with any questions. Sincerely,

# ~~QiS~ Heather R. Bjornson Regulatory Consultant to Fipronext Solutions, Inc. Direct dial: (202) 828-8945 e-mail: hbjornson@tsgusa.com 

### ,

# . , , '" , 

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F A**onn~!)prove**dO B M No. 2070-0060 

### fA',. UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

### {lOlI'Z ' 401 M Street, S.W. ,j WASHINGTON, D.C. 20460 Paperwork Reduction Act Notice: The public reporting burden for this collection of information is estimated to average 1.25 hours per response for registration and 0.25 hours per response for reregistration and special review activifies. [ncluding time for reading the instructions and completing the necessaryforms. Send comments regarding burden estimate or any other aspect ofthis**co~ection** of information, including suggestions for reducing the burden to". Dkector, OPPE Information Management Division (2137), U.S. Environmental Protection Agency, 401 MStreet, S.w., Washington, DC 20460. Do not send the completed fonn to this address, Certification with Respect to Citation of Data Appr,canfS/Registrant's Name. Address, and Telephone Number EPA Rel1istration Number/File Symbol Fipronext Solutions, Inc,: 3259 Harvey Court, Pleasanton, CA 94588. Tel :510-441-0800 87650_R Active tnoredientfs) and/or reoresentative test comooundfs) Date Fipronil (PC Code 129121) Avgus119,2010 General Use Pattem(s)**(~st** all those claimed for this product usinQ 40 CFR Part 158) Product Name Domestic tndoor Fipronit TeChnical NOTE: Ifyour product is a 100% repackaging ofanother purchased EPA-registered product labeled for all the same uses on your label. you do not need to submit this fonn. You must submit the Formulators Exempflon Statement (EPA Form 8570-27). 

# 0 Iam responding to a Data-CalHn Notice, and have included lvith lIlis form a list ofcompanies sent offers of compensalion (the Data Matrixfonn shoUld be used for this purpose).
SECTtON t: METHOD DF DATA SUPPORT (Check one method only) 

# 0 I am uS'lng the cite-all method ofsvpport, and have included with lJ1is form 

# 0 I am using lJ1e selective method ofsvpport (or cite·all option a list ofcompanies sent offers ofcompensation (the Data Matrix form under the selective method), and have included with this form a shOUld be used for this purpose). completed list ofdata requirements (the Data Matrix form must be used). SECTION II: GENERAL OFFER TO PAY [Required ifusing the**c~e-all** method or When using lJ1e cite-all option under lJ1e selective method to satisfy one or more data requirementsl 

# 0 I hereby offer and agree to pay compensation. to other persons, with regard to the approval oflJ1is application, to the extent required by FIFRA.
SECTlDN Itt: CERTtFtCAnON I certify lIlatthis application for registration, this form for reregistration. or tills Data-Call-In response is supported by all data submitted or dted in the application for reg'lstration, lIle fonn for reregistration, orthe Data-Call-tn response. tn addition, ifllle cite-all option or cite-all option under the selective method is indicated in Section t, this application is supported by all data in the Agency's ftles that (t) concem the properties or effects of this product or an identical or substantially similar product, or one or more ofthe ingredients in this product; and (2) is atype ofdata that would be required to be submitted underthe data requirements in effect on the date ofapproval oflJ1is application ifthe application sought the initial registration ofa product of identical or Similar composijion and uses. I certify that for each exclusive use study dted in svpport ofthis registration or reregistration, that Iam the original data SUbmitteror that t have obtained the**wr~ten** permission ofthe original data submitterto cite lJ1at study. I certify that for each study**c~ed** in support ofthis registration or reregistration that is not an exclusive use study, either: (a) I am the original data submitter; Ib) I have obtained the permission of the original data subm'ltterto use the study in support ofthis**app~cation;** (c) all periods ofeligibility for compensation have expired for the study; Id) the study is in the public literature; or (e) I have notffied in**wr~ing** the company that SUbmitted the <ollie,y 'artd have offered (I) to pay compensation to the extent required by sections 3{c){1I{F) and/or 3{cI(2){B) of FtFRA; am (i,) to commence negot"lations to dc-tcr:l1:ne the amount and tenns ofcompensation, if any, to be paid for the use ofthe study. Icertify that in all instances where an offer of compensat"lon is required, copies ofall offers to pay COmpensation and evidence oftheirdetiVery in 

## " 

## ,

# " accordance with sectionS 3(c)11)(F) and/or 3{c){2){B) of FIFRA are availabte and will be submitted to the Agency upon request. Should tfail to produce such J evidence to the Agency upon request t understand lJ1at the Agency may initiate action to deny, cancel or suspend the registration of my**prodl,.c~in** cunfonnity**~Iith** FIFRA. ' , 

# . " 

## "



## , t ackno';rtedge(hatany 

# " I certify thatthe statements r have made on this form and att attachments to tt are true, accurate, Clnd comptete. 

## ," knowingly fatse or misleading statement may be punishabte by fine or imprisonment or both underappticabte law. ' , , , ' 

## " " 

### ,

# i~,tr~I•.

# ~, Q Date Typed or Printed Name and Title 

### ••• 

## Q 8/19/2010 Heather R. Bjornson, Regulatory**JI;p~t,** i '0 'Iabl "b i on rni . 

# , " EPA Fonn 8570.34 (9 97) Electron c and Pape verslO s ava, e. S m t ty Pap ve on, 

## .,..

# I(e}

" ",'>••**'~** FormApproved O\i1B No, 2070-0060 UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 401 M 

### Street, S.W. WASHINGTON, D.C. 20460 Paperwork Reduction Act Nottce: The Public reporting burden fOr this collection ofinformation is estimated to average 0.25 hoursper response for registration activities and 0.25 hours per response or reregistration and speCial reviewactivities, including time or reading the instructions and completing the necessaryforms. Send comments regarding the burden or anyother aspect of this collection of information, including suggestions br reducing the burden to: Director, CPP Information Management Division (2137)U,S. Envionmental Protection**Agenc~** 401 M Street, S.W, Washington, DC 20460. Do not send the form to this address. DATA MATRIX
Date August 19, 2010 EPA Reg. No.IFite Symbot Page t of4 87650-R Applicant's/Registrant Name and Address Product Fipronext Solutions. Inc. 3259 HalVeyCourt Fipronif Technical Pleasanton, CA 94588 Ingredient Fipronil Guideline Reference Number Guideline Study Name . MRtD Number Submitter Status Note OPPTS 830.1550 Product Identityand Composition 48104001 Flpronext Solutions, tnc. 

### OWN OPPTS 830.1600 Description ofStarting Materials 48104001 Fipronext Solutions, Inc. 

### OWN OPPTS 830.1650 Oescription of]the Formulation Process 48104001 Fipronext Sotutions, tnc. 

### OWN
OPPTS 830.1670 Discussion ofthe Formation of Impurities 48104001 Fipronext Solutions, Inc. 

### OWN OPPTS 830.1700 PreliminaryAnatysis 48104004 Fipronext Solutions, Inc. 

### OWN



## . OPPTS 830.1750 Certified Limits 48104001 Fipronext Solutions. Inc. 

### OWN OPPTS 830.1800 Enforcement Anal)o1:ical Method 48104001 Fipronext Solutions, Inc. 

### OWN



# . OPPTS 830.6302' Color 48104002 Fipronext Solutions, tnc. 

### OWN OPPTS 830.6303 Physical State 48104002 Fipronext SOlutions, tnc. 

### OWN OPPTS 830.6304 Odor ,. "w::8104002 u "' w F!prone::-:t Solutions, Inc. '" " 

# · · . . . 

# . . OWN 

# ·
. 

# · OPPTS 830.6313 Stability (High Temperature etc) 

# · .**"Wro4!)0~** : "**~ ftpJon~extSolutions,**  Inc. 

### OWN 

# · .



# . · 

# . . OPPTS 830.7000 pH 48104003 Fipronext Solutions, tnc. 

### OWN Signature 

### • 

# · . ...**~/Z4~** 

# · · • • Name and Title 

### Dme


# ... .. 

# · Heather R. Bjornson, RegulatoryConsultant August 19,2010 

# · · . . 

# .. ·**~ ~**  

# .. 

# · <:nA**"'~. ,~--**  EP. m 8570-35 {9-g7] Etectronic and Paperversionsavailable. Submit only Paper version Agency Internal Use Copy

# ...

..**~** Form Appro,",ed a\IIB No, 2070-0060 UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 401 M Street, S.W. WASHINGTON, D.C. 20460 Paperwork Reduction Act Notice: The Public reporting bUrden for this collection ofinformation is estimated to average 0.25 hours per response or registration activities and 0.25 hoursper response for reregistration and special re"iew**activ~ies.** including time br reading the instructions and completing the necl:5sary forms_ Send comments regarding the burden or anyother aspect of this collection of information, including suggestions br reducing the burden to: Director, CPP Information Management O"ivision (2 !37)U.S. En"ionmental Protection Agency, 401 M Street, S.W., Washington, DC 20460. Do not send the form to this address.

Date August 19, 2010 Apptlcant's/Registrant Name and Address Fipronexl Solutions, Inc. 3259 HarveyCourt Pleasanton, CA94588 Ingredient Fipronil Guideline Reference Number Guideline Study Name OPPTS 830.7050 UVNisibleAbsorption OPPTS 830.7200 Melting Point OPPTS 830.7220 Boiling Point OPPTS 830.7300 Density, Specific Gravity OPPTS 830.7370 Dissociation Constant OPPTS.7550/7760n770 Octanol Water Partition Coefficient OPPTS 830.7840 Water Sotubility OPPTS 830.7950 Vapor Pressure
OPPTS870.1100 Acute Oral Toxicity OPPTS 870. f200 Acute Dermal Toxicity OPPTS 870.1300 Acute Inhalatlon Toxicity OPPTS 870.2400 Primary Eye Irritation OPPTS 870.2500 Primary Skin Irritation Signature

# ~(2f2y=:-- I::nA**,,~** a,,"'''' .,t: ,... ....." "',

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MRtD Number 48104003 48t04002 48104002 48104002 48104002 48104002 48104002 48104002
"CITE-ALL" "CITE-ALL'· "CITE-ALL" "CITE-ALL" "CITE-ALL"



## ..**~** w ,.**~** c "" " " " " " " " c " " " "**~ ~**  " " " " "" " " " "

"" " "" EPA Reg, No.lFile Symbot**87650~R** Product Fipronil Technical

Submitter Fiprone:d Solutions. Inc. Fipronext Solutions, Inc. Fipronext Solutions, Inc. Fipronext Solutions, Inc. Fipronexl Sotutions, tnc. Fipronext Solutions, Inc. Fipronext Solutions, Inc. Fipronexl Solutions, Inc.
See attached data submitters tist See attached data submitters list See attached data submitters list See attached data submitters list See attached data submitters list Name and Title Status 

### OWN OWN OWN OWN OWN OWN OWN OWN
PAY PAY PAY PAY PAY**"~~H~**..**t~er** R. Bjornson, RegulatoryConsultant " " "


## . Agency Internat Use Copy Page 2 of4

Note

Date August 19, 2010 

# I**~** Form Approved O\i1B No, 2070-0060 UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

### 401 MStreet, S.W. WASHINGTON, D,C, 20460 Paperwork Reduction Act Notice: The Public reporting burden for this collection ofinformation is estimated to average 0.25 hours per response 6r registratKm activities and 0.25 hours per response or reregistration and special reviewactivities, inclu::ling time for reading the instructions and completing the necessaryforms. Send comments regarding the burden or anyother aspect of this collection of information, including suggestions br reducing the burden to: DirectOI, (pp tnformation Management Dr.-ision (2137)U.S. Environmental Protection Agency401 M Street, S.W, Washington, DC 20460. Do not send the form to this address.

Date August 19, 2010 Appticant'sfRegistrant Name and Address Fipronext Sotutions, Inc. 3259 Harvey Court Pleasanton, CA 94588 Ingredient Fipronit Gutdeline Reference Number Guidetine Study Name QPPTS 870.2600 Skin Sensitization OPPTS 870.3toO 90 Day Oral Toxicity
- Rats OPPTS 870.3150 90 Day Oral Toxicity Dog QPPTS 870.3250 90 Day Dermal**Toxic~y** OPPTS 870. 3465 90 Day Inhalation Toxicity OPPTS 870.3700 Prenatal Development Toxicity in Rabbits QPPTS 870.3700 Prenatal Development Toxicity in Rats OPPTS 870.4100 Chronic Oral Toxicity QPPTS 870.4200 Carcinogenicity QPPTS 870.5100 Reverse Mutation Assay**s;g"'ture~** 

# (2!5J'- DATA MATRIX

MRtD Number "CITE-ALL" "CITE-ALL' "CITE-ALL" "CITE-ALL" "CITE-ALL" "CITE-ALL" "CITE-AlL" "CITE-ALL" "CITE-ALL" "CITE-All"



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•• > EPA Reg. No./FHe Symbot 87650·R Product Rpronil Technical

Submitter See attached data submitters list See attached data submitters list See attached data SUbmitters list See attaChed data submitters list See attached data submitters list See attached data submitters list See attached data submitters list See attached data submitters list See attached data submitters list See attached data submitters list Status PAY PAY PAY PAY PAY PAY pAY PAY PAY PAY**N~';'~** and-Titte**~** "Heather R. Bjornson, RegulatoryConsultant



## . > Page 3 of4

Note

Date

August 19,2010 

# l ·/1Form Approved O\i1B No, 2070-{}000 UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 401 M Street, 

### S.W. WASHINGTON, D.C, 20460 Paperwork Reduction Act Notice: The Public reporting burden fur this collection ofinformation is estimated to average 0.25 hours per response 6r registration activities and 0.25 hours per response-or reregistration and special review activities, including time -Or reading the instructions and completing the necessaryforms. Send comments regarding the burden 01 anyother aspect of this collection of information, including suggestions or reducing the burden to: Director, CPP Information Management Division (2137)U.S. Environment<l Protection Agency, 401 M Street, S.w., Washington, DC 20460. Do not send the form to this address.

Date August 19, 2010 Applicant'slRegistrant Name and Address Fipronext Solutions, Inc. 3259 Harvey Court Pleasanton, CA 94588 Ingredient Fip/onil Guideline Reference Number Guideline Study Name OPPTS 870.5300 Mammalian Cett Gene Mutation OPPTS 870.5385 Chromosomal Aberration Studyin Mice OPPTS 870,6200 Acute Neurotoxicity-Rat OPPTS 870.6200 90-Day Neurotoxicity OPPTS 870.6300 Developmental Neurotoxicity OPPTS 870.7485 Metabolism and Pharmcokinetics OPPTS 870.7800 tmmunotoxicity DATA MATRIX

MRtD Number "CITE-All" "CtTE-All" "CITE-All" "CITE-All" "CITE-All" "CITE-All" "CITE-All" EPA Reg, No.lFite Symbol 87650-R Product Fipronif Technical

Submitter See attached data submitters list See attached data submitters list See attached data submitters list See attached data submitters list See attached data submitters list See attached data submitters list See attached data submitters list Page 4 of4

Status I Note PAY PAY PAY PAY PAY PAY PAY 

# l -----I

# S;g"'t~ (1.

# 0)- ________ ;:"-",'-1**~-::-:- -~i--:;-""**  

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Form Approved OMB No. 2070-0060 UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 401 M Street, S.W. WASHINGTON, D,C. 20460 Paperwork Reduction Act Notice: The Public reporting burden klr this collection of information is estimated to average 0.25 hoursper response for registration activities and 0.25 hours per response Dr reregistration and special reviewactivities, including time Dr reading the instructions and completing the necessaryforms. Send comments regarding the burden or anyother aspect of this collection of information, including suggestions br reducing the burden to: Director, <.PP Information Management Division (2137)U.S. Envionmental Protection Agency; 401 M Stleet, S.W, Washington, DC 20460. Do not send the form to this address. DATA MATRIX Date August 19, 2010 EPA Reg. No./File Symbol Page10f4 87650·R ._/ ApplJcant's/Registrant Name and Address Product Fipronext Solutions. Inc. 3259 HarveyCourt Fipronil Technical Pleasanton, CA 94588 Ingredient Fipronil Guidellne Reference Number Guideline Study Name MRID Number Submitter Status Note Fipronext Solutions, Inc. 

### OWN Fipronext Solutions. Inc. 

### OWN Fipronext Solutions, Inc. 

### OWN Fipronext Solutions, Inc. 

### OWN Fipronext-5olutions, Inc. 

### OWN Fipronext Solutions, Inc. 

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Form Approved OMB No, 2070.0060 UNITEO STATES ENVIRONMENTAL PROTECTION AGENCY 

### 401 M 

### Street, S.W. WASHINGTON, O.C. 20460 paperwork Reduction Act Notice: The Public reporting burden fix this collection ofinformalion is estimated to average 0.25 hours per response or registration activities and 0.25 hours per response or reregistratiOll and special reviewactivities, inclu:ling time for reading the instructions and completing the necessaryforms. Send comments regarding the burden or anyother aspect of this collection of information, including suggestions br reducing the burden to: Director, CPP Information Management Dwision (2137)U,S. Environmental Protection Agency 401 M Street, S.W, Washington, DC 20460. Do not send the form to this address.

Date August 19, 2010 Appticant's/Registrant Name and Address Fipronext Solutions, Inc. 3259 HarveyCourt Pleasanton, CA 94588 Ingredient Fipronil GUideline Reference Number Guideline Study Name



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MRID NLmber EPA Reg. No./File Symbol 87650-R Product Fipronil Technrcal

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Name and Title Status PAY PAY PAY PAY PAY PAY PAY PAY PAY PAY

Heather R. Bjornson, RegulatoryConsultant Page 3 of4

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Date August 19, 2010 

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IForm Approved avlB No, 2070·0060 UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 401 M Street, S.W. WASHINGTON, D.C. 20460 Paperwork Reduction Act Notice: The Pubtic reporting burden filr this cottection ofinformation is estimated to average 0.25 hours per response 6r registration activities and 0.25 hours per response or reregistration and speciat reviewactivities, including time or reading the instructions and completing the necessaryforms. Send comments regarding the burden or anyother aspect of this cottection of information, including suggestions or reducing the burden to: Director, CPP Information Management Division (2137)U.S. Environment(! Protection Agency, 401 M Street, S.w., Washington, DC 20460. Do not send the form to this address.

Date August 19, 2010 Appticant's/Registrant Name and Address Fipronext Solutions, Inc. 3259 Harvey Court Pleasanton, CA 94588 Ingredient Fipronil Guideline Reference Number Guideline Study Name

## S;g"'t""~!<.**~** DATA MATRIX

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### -_

.. - EPA Reg. No.lFite Symbol 87650·R Product Fipronif Technical

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Heather R. Bjornson, RegulatoryConsuliant Page40f4

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### STATES ENVIRONMENTAL PROTEC .,AGENCY WASHINGTON, D.C. 20460



### June 17,2010

OPP DecisionNumber: D-434093 EPA File Symbol orRegistrationNumber: 87650-R ProductName: FIPRONIL TECHNICAL EPAApplication ReceiptDate: 24-May-2010 EPA Waiver Request ReceiptDate: 24-May-2010 EPA CompanyNumber: 87650 CornpanyName: FIPRONEX SOLUTIONS,INC HEATHERBJORNSON TECHNOLOGY SCIENCES GROUP, INC FIPRONEX SOLUTIONS, INC 1150 18TH STREET, NW SUITE 1000 WASHINGTON, DC 20036- SUBIECT: Approval ofWaiver Request 

### Dear Registrant: OFFICE OF PREVENTION, PESTICIDES AND TOXIC SUBSTANCES



### The Office ofPesticide Programs has approvedyourrequestfor 75% waiver ofthe pesticideregistration fee associated withthe actionreferenced above. The decisionreview periodfor this actionwill begin onthe date ofthis letter, The Action has beenidentified as Action Code: R330 NEWMANUFACTURINGUSE PRODUCT;OLDAl;SELECTIVE CITATION; Ifyouhave any questions, please contactthe Pesticide Registration ServiceFee Ombudsman, at (703) 305-6249.
Sincerely, 

# c(J.-Jl2- A

- _ . " 

# .{r- OscarMorales,

# tCr Infonnation Technologyand Resources ManagementDivision**~** 

### Office ofPesticide Programs '"

### UNl. ED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D.C. 20460



### FIPRONEX SOLUTIONS, INC 1150 18TH STREET, NW SUITE 1000 WASHINGTON, DC 20036- May 27,2010

Report ofAnalysis for Compliance withPRNotice 86-5 OFFICE OF PREVENTION, PESTICIDES AND TOXIC SUBSTANCES



### Thankyoufor your submittal of24-MAY-IO. Our staffhas completed a preliminary analysis ofthe material. The results areprovided as follows: Your submittal was found to be in full compliance withthe standards for submission of data contained in PRNotice 86-5. A copy ofyour bibliography is enclosed;annotated 

### with MasterRecord ID's (MRIDs) assignedto each document submitted. Please use these numbers in all future references to these documents. Thankyoufor your cooperation. Ifyou have any questions concerning this data submission, please raise them withthe cognizantProduct Manager, to whomthe datahave beenreleased.

### UNI1 cO STATES ENVIRONMENTAL PROTECT'''NAGENCY WASHINGTON, D.C. 20460



### May 26, 2010

PLEASERETURNA COPY OF THIS LETTERWITH PAYMENT ORPAY ON-LINE ATwww.Pay.Gov (See Belowfor Details) OPP DecisionNumber: D-434093 EPA File Symbol orRegistrationNumber: 87650-R ProductName: FIPRONIL TECHNICAL EPA ReceiptDate: 24-May-2010 EPA Company Number: 87650 CompanyName: FIPRONEX SOLUTIONS, INC HEATHERBJORNSON TECHNOLOGY SCIENCES GROUP, INC FIPRONEX SOLUTIONS, INC 1150 18TH STREET, NW SUITE 1000 WASHINGTON, DC 20036- OFFICE OF PREVENTION, PESTICIDES AND TOXIC SUBSTAl'lCES



### SUBJECT: Receipt ofApplication and 75% Small Business Waiver Request Dear Registrant: The Office ofPesticide Programs has received your application and 75% small business waiver request. If

### you submitted datawith this application, the results ofthe PRN-86-5 screen wiIl be communicated separately. Duringthe administrative screen, the Office ofPesticide Programs has determinedthat this Action is subjectto a Pesticide Registration Service Fee as defined inthe Pesticide Registration ImprovementAct. The Action has beenidentified asAction Code: R330 NEWMANUFACTURINGUSE PRODUCT;OLD AI;SELECTIVE CITATION; Yourrequest for waiverhas beenforwarded for review. Youwill be notified in writing when a determination is made regarding your'request. 

### Ifyour waiver request is approved, the decision reviewtime periodwill start on eitherthe date ofapproval orthe receipt ofpayment, whichever is later. 

## Ifyou would like to avoid delayingthe start date, you may paythe amount listed below atthis time. Ifyourwaiverrequest is denied, you will receive aninvoice for the outstanding balance. The fee associatedwiththis action is $ 4,284 (25% or $ 17,136). Payment 

### in the amount of$ 1,144.50 has beenreceived. Please remit additionalpayment in 

### the amount of$ 

### 3,139.50 to:

### ByUSPS: USEPA Washington Finance Center Pesticide Registration Service Fee PO Box 979074 St. Louis, MO 63197-9000 By Courier:

U.S. Bank GovernmentLockbox 979074 1005 Convention Plaza SL-MO-C2-GL St. Louis, MO 63197 Telephone: (412) 236-2294 All payments must be in United States currencyby check, bank draft, or money order drawn totheorder ofthe Environmental Protection Agency. To ensure propercredit, please writethe OPP DECISIONNUMBER on your check, and enclose a copyofthis letterwithyour payment. EffectiveNovember 1,2006, fees maybepaid on-line viacredit cardor electronic fund transfer. To submit a payment on-line, visitwww.pay.gov. From the pay.gov home page, select "search 

### byfann name." From the nextpage, select "P," then click on "Pesticide Registration Improvement Act. FeePayment" and completethe form, making certainto usethe decision number and registrationnumber onthe invoice you receive from the PesticideProgram in the space provided. A PRlA decision time reviewperiod will not startuntil a fee waiver is granted and/orthe Agency**recei~es** 

### certification that the outstanding fee has beenpaid. Ifthe Agency does not receive certification ofpayment for this action or a fee waiverrequestwithin the next45 days, the Agencywill presume that you no longer want to pursuethis action. The Agencywill then initiate a process thatmayresult in administrativewithdrawal ofthis action. Ifyou have any questions, please contact the Pesticide Registration Service Fee Ombudsman at (703) 305-6249.WASHINGTON IISO 181h Sireet, N.W. Suile 1000 Washington, D.C. 20036 Telephone 202 223-4392 Fax 202 872·0745

SACRAMENTO 712 Fifth Street Suite A Davis, CA 9S616 Telephone S30 757-1298 Fax S30 7S7-1299

CANADA 27S Slater Street Suite 900 Ottawa, Onlario K1P5H9 Telephone 613 247-6285 Fax 613 236·37S4

E-mall tsg@tsgusa.com**http://www.lsgu5~.com** 

### Richard Gebken Insecticide Branch Registration Division (7504P) Office of Pesticide Products U.S. Environmental Protection Agency Room**S~4900,** 

### One Potomac Yard 2777 South Crystal Drive Arlington, VA 22202-4501 May21,2010

RE: Application to Register 

### Fipronil Technical (87650-R) PRIA Category R 310
- New product, Non-fast track
Dear Mr. Gebken: 

## T[CHNOlOGY" SCI[NCtS GROU' INC

Technology Sciences Group, Inc., on behalf of Fipronext Solutions, Inc., is submitting the enclosed application to register Fipronil Technical (98.5% Fipronil). Included in this application for registration is the complete product chemistry data as well as a bridging argumentfor bridging the toxicity data that has been previously submitted tothe Agency for similar products. The remaining data requirements are being satisfied with the "cite-all" method. You will find the following in support of this application: 1) Application for pesticide registration, 2) Confidential statement of formula, 3) Certification with respect to citation of data, 4) Data matrices (confidential and an non-confidential version), 5) Five copies of the proposed label, 6) Volumes 1
- 6 (referto the transmittal document for specific information on E?ach data volume), 7) Small business waiver application and supporting documentation, and 8) PRIA pre-payment receipt: Pay.gov tracking 10: 250S70L8; Agency tracking 10: 74117800617. Please do not hesitate to contact me directlywith any questions. Sincerely,

# ~Vv--fl.**(!,~** Heather 

### R. Bjornson Regulatory Consultant to Fipronext Solutions, Inc. Direct dial: (202) 828-8945 e-mail: hbjomson@tsgusa.com , 

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### VOLUME 1 OF 6 OF SUBMISSION TRANSMITTAL DOCUMENT NAME AND ADDRESS OF SUBMITTER: Fipronext Solutions, Inc. 

### 3259 Harvey Court Pleasanton, CA 94588


### REGULATORYACTION: 

### 481040'()0

PRIA Category R 310 -Application to register 

### Fipronil **Technical (87650-R).** 
TRANSMITTAL DATE: May 21, 2010 LIST OF SUBMITTED STUDIES: MRID VOLUME NUMBER NUMBER EPA STUDY TITLE 10f6 

### 48104001 20f6


### 48104002 30f6


### 48104003 40f6



### 48104004 5 of 

### 6


### 48104005 6 of 

### 6

COMPANY NAME: 

### (Transmittal Document) **FipronH Technical**  Product Chemistry - Part A 

### Fipronil **Technical** Product Chemistry - Part 8 

### Fipronil Technical Physical Properties 

### FiproniJ **Technical** Preliminary Analysis 

### Fipronil **Technical** Toxicity Bridging Discussion Fipronext Solutions, Inc.

Page 1 of 2 GUIDELINE NUMBER

830.1000
- 830.1900

830.6302
- 830.7950 830.6313,830.7000 830.7050
830.1700
870.1100
- 870.4300

### COMPANY OFFICIAL:
COMPANY CONTACT: 

### Heather R. 

### Bjornson, ReWiatory"""Agtmt Heather 

### R. Bjornson, Regulatory Agent 

### Technology Sciences Group, Inc. 1150 18th Street, NW. 

### Ste. 1000 Washington, DC 20036 (202) 828-8945

Page 2 of2Pfe.6e,•• d i ,truatiOrl$ on

## rev.,... IHfo", com". 

### , i form· Form Approved. ;"8 No. 2010-OO8C 12.28·95 United SUItes 

# D Registration OPP Identifier Numbel 

# &EPA Environmental Protection Agency Amendment Washington, DC 20460 

## Other Application for Pesticide
- Section 

### I t. Company/P/oduct Number 2. EPA Product Maneger 3. P/(lpos(ld ClsssificeD(ln 

### 87650-R Richard Gebken

### ~None 

# D R(lstlictod 4. ComponylPr(lduct INom(l1 

# PM.

Fipronil Technkal 

### 10 insecticide Branch 5. N(lma lind Address (If Applicont (Inc/udfl ZIP Codol 

### 6. Expedited Reveiw. In accordance with FIFRA Section 3{cH3) Fipronext Solutions, Inc. IbWI, my product is simitat or identical in composition and labeling 

### 3259 Harvey Court to; Pleasanton, CA 

### 94588 EPA Reg. No. 

# o Chock ifthis is 8 noWedd,,,ss Product Name Section
- 

### II 

# D Am(lndm(lnt· Explain billow. 

# U Finel printod lebels in repson!lll t(l Agency 10ttlll dlltod 

# D Rasubmis!lion in losponsa to Ag(lncy lettal deted 

# D**~Me** Too" Applicetj(ln. 

# D Notification
- Exploin bolow. 

# D Othel
- Exploin bolow. Explanation; Usa edditionel poge{sl if nocessery. tFor section I and Soclien II.) PRIACategory R 310: New manufacturing use p/oduct. unregistered source. Please confirm with Heather Bjornson at: hbiomson@tsgusa.com. PRIA Pre-paymenl: Pay.gov tracking 10: 250S70L8: Agency Tracking 10: 741176006t7.

Section
- 

### III 1. Meterial Thi. Product Witt Be Packeged In: Child·Resistent Pllckoging Unit Packaging 

# !Water Solubla Pockllging 2. Type of Contoinor 

# l2f"**t~t** 

# 'B y" 

# gM"OI ,( No ,( No ,( No Plostic Glass • Certification must If**~Yes~** No. par If**"Yos~** No. P(ll Paper Unit Pockeging wgt. containal Package wgt contmnlll Other (Spllcityt b(J submittfJd I 3. Loclltion of Net Contants Info/motion 4. Size{s) Retail Container 5. location of Lobel Oirllction!!



## [{j Lablll 

# U Containllr 

# W 6, Mannal in Which Lobel is Affix(ld to Pr(lduct

### ~ lithograph 

# U Othor .t Pllpllr Ptlulld Stanci ed

## Section

- IV 1. Conlect Point {Comp/Ma itoms directly bolow fo, idenrification ofindivfduBl to btl contac/od, ifnecflssary, toprocoss this BPplication.l Name Titlll Teleph(ln8 No. (Include Araa Code) Heather R Bjornson, Technology Sciences Group. Inc. Regulatory Consultant (202) 628+8945 Certification 6. DII!e'A.Jpll}ation I cllrtify thst the statements I hevlI made on this form end all attechm(lnts thareto orll tlU(I, accurllte and comp)6tbO, > Rllcbmd • 

### , I ocknowlodgll that IIny knowlingtly false 01 misleading statamont mey be punishoblo by fin!! or lmposorvnllnt**~r** 

### ,**J~talJ'lped)** both undor applicable law. 

### , , " 

### , , , 

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## "

# 2~ 3. TItlll , 1 , t • 

## " 

# « 0, , RegUlatory Consultanllo Fipronext Solutions, Inc. " , " > , , -'

, 

# '-'--

, I 

### , " 

### , 4. Typod Name 5. Dato 

### ,


# ." 

### , " , Heather R. Bjornson 

### May 21,2010 " 

### " 

### , ,

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# - , 

# - - - EPA FO/m 8570 1 (Rev. 3 94) PraVlous adltlons aro obsol(ltll. Whit. EPA FINo Copy longln.l) y.now Applicant Copy

### Pay.gov

- Online Payment

Online 

### Payment Step 3: Confirm Payment Thank you. Yourtransaction has been successfully completed. Pay.gov Tracking Information Application Name: PRIA Service Fees Pay.govTracking 10: 250S70L8 Agency Tracking 10: 74117800617 Transaction Date and Time: 0512412010 10:50 EDT Payment Summary Address Information Account Information Payment Information 

### Page 1of!

1 

## 1213

Account Holder Heather 

### R. Card Type: American Express PaymentAmount: $1,144.50 Name: Bjornson 1150 18th Street Billing Address: NW Billing

### Addres2~ Ste. 1000 City: Washington State 1Province: DC Zip 

### 1Postal 20036 Code: Country: USA Card Number: ******h***1436 Transaction Date 05/24/201 0 Decision and Time: 10:50 EDT Number: Registration 87650-R Number: Company Fipronext Name: Solutions, Inc. Company 87650

Number: Action Code: R31 0



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### , https:!!www.pay.gov!paygov!payments!authorizePlasticCardPayment.htrnl 5/24/2010Form Aooroved OMB No. 2070-0060 UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 401 M Street, SoW. WASHINGTON, D.C. 20460 Paperwork RedUction Act Notice: The publiC reporting burden for this collection of information is estimated to average 1.25 hours per response for registration aru:i 0.25 hours per response for reregistration and special review activities, induding time forreading the instructions and completing the necessary fonns. Send comments regarding burden estimate or any other aspect ofthis collection of information, including suggestions for reducing the burden to: Director, OPPE Information Management Division (2137), U.S. Environmental Protection Agency, 401 M Street. S.w., Washington. DC 20460. Do not send the completed form to this address. Certtfication with Respectto Citation ofData Applicanfs/Repistranfs Name, Address. and Telephone Number Fipronext SolutionS,lnc.: 3259 Harvey Court, Pteasanton, CA 94588. Tel.: 510-441-0800 Active tnaredientls) and/or representative test compoundls) Fipronil (PC Code 129121) EPA Reqistration Number/Fite Symbol 87650-R Date May21,2010 General Use PaUem(s) (list all those claimed for this product uSinp 40 CFR Part t58) Terrestrial Food Crop, Terrestrial Non-Food Product Name Fipronil Technical NOTE: II your product rs a 100% repackaging ofanother purchased EPA-registered product labeled for all the same uses on your label, you do not need to submit this form. You must submit the Formulator's Exemption Statement (EPA Form 8570-27). 

# o
o I am respcr1ding to a Dala-Gall-ln Notice, an::! have induded with this form af,st ofcompanies sent offers ofcompensation (the Data Matrixform shOUld be used lor this purpose).
SEcnON I: METHOO OF DATA SUPPORT (Check one methOd only) I am using the cite-all method ofsupport, and have included with this form a fist ofcompan·les sent offers ofcompensat"lon (the Data Matrixform should be used for this purpose). I am using Ille setective melllod ofsupport (or cite-all option under Ille selective method), aru:i have induded**w~h** this form a completed list ofdata requirements (the Data Matrix form must be used). SECTION II: GENERAL OFFER TO PAY [Required ifusing Ille**c~e-all** method orwhen using Ille cite-all option under Ille selective method to S<1tisfy one or more data requirements] 

# [J I hereby offer and agree to pay compensation. to other persons. with regard to the approval of Illis application, to the extent required

### b~ FIFRA.

SECTION Itt: CERTtFtCAnON I certify that this application for registration, this form for reregistration, orthis Data-Gall-In response is supported by all data submitted or cited in Ille appl"lcafion for reg·,stration, Ille form for reregistration, orthe Data-Call-In response. In addition, ifthe cite-all option or cite-alt option underthe selective method is indicated in Section I, this application is supported by all data in the Agency's files that (t) concem the properties oreffects of this product or an identical or substantially similar product. or one or more ofthe ingredients in this product; and (2) is atype ofdata that would be required to be submitted underthe data requirements in effect on the date ofapproval ofthis application ifthe application sought the initial registration ofa product of identical or similar composition and uses. Icertily that far each exclUSive use stUdy cited in support ofthis registration or reregistration, that Iam the original data submitter orthat Ihave Obtained the written permission ofthe orig·lnat data subm·rtterto c·rte that study. I certify that for each study**c~ed** in support ofthis registration or reregistration that is not an exdusive use study. either: (a) I am the originat data submitter: (b) I have obtained the permission ofthe original data submitterto use the study in support ofthis application; (c) all periods ofeligibility for compensation have expired for the study; (d) the study is in the public literature; or (e) t have notifed in writing the company Illat**subm~ted** the study and have offered (t) to pay compensation to the extent required by sections 3(c)(1)(F) and/or 3(c)(2)(B) of FIFRA: and (ii) to commence negotiations to determine the amount and terms of compensation, ifany, to be paid for the use ofthe study. I certify that in all instances where an offer ofcompensation is required, copies ofall offers to pay compensation and evidence oftheirdelivery in accordance with sections 3(c)(t)(F) and/or 3(c)(2)(B) of FIFRA are available and will be submitted to the Agency upon request. Should Ifail toytoOy&>,SUCh evidence to the Agency upon request. I understand that the Agency may inWate action to deny, cancel or suspend the registra\iI'J>,t'J:ry product :n'Confllrmily with FtFRA. ' :: ' 

### " 

### , t certify thatthe statements t have made on this form and all attachments to it are true, accurate, and COm91,t.e, J xknow:cdJethat any knowingly false or misteading statement may be punishable by fine or tmprisonment or both underappllcabte taw.**~:** ,j, Date 5121/2010 EPA Form 8570-34 (9-97) Electronic and Paperversions available. &lbmitonly Paperversion. • ,j "**~ ~**  "**~** Typed or Printed**N~";;J ~nd'Titie** **~** , Heather R. Btarns01!, F.egulatory A3ent '

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# FIPRONIL **TECHNICAL** For Manufacturing Use Only

ACTIVE INGREDIENT: Fipronil: 5-amino-1-(2,6-dichloro-4-(trifluoromethyl} phenyl}-4-((1 ,R,S)-trifluoromethyl}sulfinyl} -1-H-pyrazole-3-carbonitrile

........................................................................98.0% 

### INERT INGREDIENTS

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

### .......................2.00/0 TOTAL

..................................................................................................... 100.0%


# KEEP OUT OF REACH OF CHILDREN 

# WARNING Si usted no entiende la etiqueta, busque a alguien para que se la explique a usted en detalle. (If you do not understand this label, find someone 

### to.explain 

### it to you.)



### EPA Reg. No.: XXXXX-R EPA Est. No.: XXXXX-XXX-XXX Net Contents:

Manufactured for: 

### Fironext Solutions, Inc. 3259 Harvey Court Pleasanton, CA 94588 

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Fiproni! Technical label version (1) ated May 21,2010 1:)"",,,,, 1 I'If

### FIRST AID IF SWALLOWED 

### Immediately call poison control center or doctorfor treatment advice. Do not induce vomiting unless told to do so by a poison control center or doctor. Have person sip a glass ofwater 

### if able to swallow. Do not give anYthing by mouth to an unconscious person. IF ON SKIN OR Take off contaminated clothing. CLOTHING Rinse skin immediately with plenty ofwaterfor 15-20 minutes. Call a poison control center ordoctorfortreatment advice. IF INHALED 

### Move person to fresh air. If 

### person is not breathing, call 911 oran ambulance, then give artificial respiration, preferably by mouth-to-mouth 

### if possible. Call a poison control center or doctorfor further treatment advice. IF IN EYES Hold eye open and rinse slowly and gentlywith waterfor 15-20 

### minutes. Remove contact lenses, if present, after the first 5 minutes, then continue rinsing. Call a poison control center ordoctorfortreatment advice. HOT LINE NUMBER Have the product container or labelwith you when calling a poison control center or doctor, or going for treatment. You may also contact 1-800-334-7577for emergency medical treatment information. NOTE TO PHYSICIAN: There is no specific antidote. All treatment should be based on observed signs and symptons of distress in the patient. Overexposure to materials otherthan this product may have occurred. PRECAUTIONARY STATEMENTS HAZARD TO HUMANS AND DOMESTIC ANIMALS- WARNING: May be latal ilswallowed, absorbed through the skin or inhaled. Causes substantial but temporary eye injury. Do not get in eyes, on skin, or on clothing. Weargoggles, face shield, or safety glasses. Wash thoroughly with soap and water after handling and before eating, drinking, or using tobacco. Wear protective clothing and rubber gloves. Remove contaminated clothing and wash clothing before reuse. Do not breathe dust. Wear a dusUmist filtering respirator (MSHAINIOSH approval number prefix TC-21C), or a NIOSH approved respirator with any N, R, P or HE filter. 

### SYMPTOMS OF POISONING: In severe cases of overexposure by oral ingestion, lethargy, muscle tremors, and, in extreme cases, possibly convulsions, may occur. ENVIRONMENTAL HAZARDS This product is toxic to birds, fish, estuarine and aquatic invertebrates. Do not discharge effluent containing this product into lakes, streams, ponds, estuaries, oceans, or otherwaters unless in accordance with the requirements of a Natiol1al**pollut'imLD~scharge** 

### Elimination System (NPDES) permit and the permitting authority

## .h'a'~**b~'eri** nqtlfled in writing prior to discharge. Do not discharge effluent containing this product'to

### sev,e~ systems without previously notifying the local sewage treatment plant authority. For guidance, contact your State Water Board or Regional Office of the EPA.

Fipronil Technical label version (1) dated May 21, 2010

### DIRECTIONS FOR USE It is a 

### violation of lawto use this product in a manner inconsistent with its labeling. Read entire label before using this product. 

### Onlyforformulation into insecticide or rodenticide products. Formulators using this product are responsible for obtaining EPA registration fortheirformulated 

### product which may be labeled for use patterns as found listed on this label. Only forformulation into products for the following uses: 

### • Domestic Indoor (household, etc.) • Domestic Outdoor (fawns, perimeters, 

### & ornamentals), 

### • Commercial/lndustriallfnstitutional (indoor & 

### outdoor), • Food Handling Establishments (edible product areas), • Terrestrial Non-Food (sod farms, golfcourses, non-agricultural sites), • Modes oftransportation. Not for use to formulate products for termite control or liquid sprayable formulations forthe above cited use sites. STORAGE AND DISPOSAL Do not contaminate water, food, orfeed by storage or disposal. PESTICIDE STORAGE Store unused product in original container only, out of 

### reach of children and animals. PESTICIDE DISPOSAL Pesticide wastes are acutely hazardous. Improperdisposal of 

### excess pesticide is a violation of Federal law. Ifthese wastes cannot be 

### disposed of by use according to label instructions, contact your State Pesticide or Environment Control Agency, orthe Hazardous Waste representative at the nearest EPA Regional Office for guidance. In case of spill, clean up spillage using shovels and avoiding skin contact. Carefully scoop up loose material and place it in appropriate containers so as to avoid dust generation. Decontaminate tools and equipment following cleanup. In case of large scale spillage in the U.S. regarding this product, call 1·800·334·7577. CONTAINER DISPOSAL Nonrefillable container. Do not reuse or refill this container. Completely empty bag into manufacturing equipment. Then dispose ofempty bag in a sanitary landfill or, if allowed by government regulations, by burning or incineration. If bag is burned, stay out of smoke.

IMPORTANT: READ BEFORE USE Read the entire Directions for Use, Disclaimet.

## .ef!WClrr~nii;;~ and Limitations of Liability before

, " 

### using this product. Ifterms are not acceptablE:l"r;E:itun;l,the

### ~r,;opened product container at once. By using this product, useror buyer aC,cepts.the foflow,ing Disclaimer ofWarranties and Limitations of LiabWty.

.

Fipronil Technical label version (1) dated May 21, 2010**...,~~~** '"**~&** A

### DISCLAIMER OF WARRANTIES: 

### TO THE EXTENT CONSISTENTWITH APPLICABLE LAW, FIPRONEXT SOLUTIONS, INC. MAKES NO OTHER WARRANTIES, EXPRESS OR IMPLIED, OF MERCHANTABILITY OR OF FITNESS FORA PARTICULAR PURPOSE OR OTHERWISE, THAT EXTEND BEYOND THE STATEMENTS MADE ON THIS LABEL. No agent of Fipronext 

### Solutions, Inc. is authorized to make any warranties beyond those contained herein or to modify the warranties contained herein. TO THE EXTENT CONSISTENTWITH APPLICABLE LAW, FIPRONEXT SOLUTIONS, INC. DISCLAIMS ANY LIABILITY WHATSOEVER FOR SPECIAL INCIDENTAL OR CONSEQUENTIAL DAMAGES RESULTING FROM THE USE OR HANDLING OF THIS PRODUCT LIMITATIONS OF LIABILITY: TO THE EXTENT CONSISTENTWITH APPLICABLE LAW THE EXCLUSIVE REMEDY OF THE USER OR BUYER FOR ANY AND ALL LOSSES, INJURIES OR DAMAGES RESULTING FROM THE USE OR HANDLING OF THIS PRODUCT. WHETHER IN CONTRACT, WARRANTY, TORT, NEGLIGENCE, STRICT LIABILITY OR OTHERWISE, SHALL NOT EXCEED THE PURCHASE PRICE PAID, OR AT FIPRONEXT SOLUTIONS, INC. ELECTION, THE REPLACEMENT OF PRODUCT

Batch Code:



## : , , , , , , , , , 

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### Technical label version (1) dated May 21,2010"

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## , 

# ,**~** g:)J'i 

# b-M_1JJ1!:; " .-/' Form Approved OMB No, 2070-0060

--**~** 

### - UNITED STATES ENVIRONMENTAL PROTECTION AGENCY " , 

### 401 M 

### Street, S.W. WASHINGTON, D,C, 20460 , Paperwork Reduction Act Notice; The Public reporting burden fur this cOllection ofinformation is estimated to average 0.25 hoursper response for registration activities atlt:. 0.15 :J_J:.Jrs pe, ,esponse or reregistration and special review8ctivities, including time br reading the instructions and completing the necessaryforrns. Send comments regarding the burden or anyothtoT a'lpeC:l of £hir. colrJction of information, including suggestions br reducing the burden to: Director, (PP Information Management Division (2 t37)U.S. Envionmental Protection Agency, 401 M Street, 

### t/w.,**W",~h,ngtC'n.** 0(:: 20460. Do not send the form to this address, " DATA MATRIX Date May 21, 2010 EPA Reg. No.lFite Symbot Page 1 of2 87650-R ,-,,' Appticant's/Registrant Name and Address Product Fipronext Solutions, tnc. 3259 HarveyCourt Fipronil Technical Pleasanton, CA 94588 Ingredient Fipronil Guideline Reference Number Guideline Study Name MRID Number Submitter Status Note OPPTS 830.1550 Product Identityand Composition This submission Fipronext Solutions, Inc. 

### OWN OPPTS 830.1600 Description ofStarting Materials This submission Fipronext Solutions, Inc. 

### OWN OPPTS 830. t650 Description of Ithe Formulation Process This submission Fipronext Solutions, Inc. 

### OWN OPPTS 830.1670 Discussion ofthe Formation oftmpucities This submission Fipronext Solutions, tnc, 

### OWN OPPTS 830.1750 Certified limits This submission Fipronext Solutions, Inc. 

### OWN



# - OPPTS 830.1800 EnforcementAnaMical Method This submission Fipronext Solutions, Inc. 

### OWN

OPPTS 830.6302 Color This submission Fipronext Solutions, Inc. OWN OPPTS 830.6303 Physical Stale This submission Fipronext Solutions, Inc. 

### OWN OPPTS 830.6304 Odor This submission Fipronex! Solutions, Inc. 

### OWN DPPTS 830.6313 Stability (High Temperature etc) This submission Fipronext Solutions, Inc, 

### OWN OPPTS 830.7000 pH This submission Fipronext Solutions, Inc. 

### OWN Stgnature

# ~\2-f!,~ Name and Title 

## 0." Heather R. Bjornson, Regulatory Consultant May 21, 2010
-_ ... -_. EpA Form 8570-35 (9-97) Electronic and Paper versions available. Submit onlyPaper version Agency Internal Use Copy';;"**,;,,~** \ Form Approved CXVIB No, 2070-0060 UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 401 M Street, S.W. WASHINGTON, D.C. 20460 Paperwork Reduction Act Notice: The Public reporting burden brthis coliection ofinformalion is estimated to average 0.25 hours per response lir registration activities and 0.25 hours per response Dr reregistration and special review activities, including time Dr reading the instructions and completing the necessaryforms. Send commentsregarding the burden or anyother aspect ot**~his** co.II"lction of information, including suggestions Dr reducing the burden to: Drector, OPP Informafion Management Division (2137)U.S. Environmental Protecfion Agency401 M Street, S.\:.V:: Was:"ing',on, DC"20460. Do not send the form to this address.**~** ___.._ 

## ",_c·"''''

_____ _

Date May 21, 2010 Applicant's/Registrant Name and Address Fipronext Solutions, Inc, 3259 HaNeyCourt Pleasanton, CA 94588 Ingredient Fipronil Guideline Reference Number Guideline Study Name OPPTS 830.7050 UVNisible Absorption OPPTS 830,7200 Melting Point OPPTS 830.7220 Boiling Point OPPTS 830.7300 Density, Specific Grav'lty OPPTS 830,7370 Dissociation Constant OPPTS.75501776017770 Octanol water Partition Coefficient OPPTS 830.7840 Water Solubility OPPTS 830.7950 Vapor Pressure
"CITE-All"'

Signature

# ~~R,8{s' 

# - "'Oll 10"""

..... 0<;7(L"-", 10,071**""Q~'~n;~ ~"**  ...**O~~M "~_;~n~** **~,,~a~'-I_** C>••h_"**_~I, ,"~**  ___**,.~.~,**__ 

# " Iypape 'sionDATA MATRIX

MRID Number This submission This submission This submission This submiss'lon This submission This submission This submission This submission This submission EPA Reg. No.lFHe Symbol 87650-R Product Fipronil Technical

Submitter Fipronext Solutions, Inc. Fipronext Solulions, Inc, Fipronext Solutions, Inc. Fipronext Solutions, Inc. Fipronext Solulions, Inc. Fipronext Solutions, Inc. Fipronext Solutions, Inc. Fipronext Solutions, Inc. Fipronext Solutions, Inc.
See attached data submiUer's list

Nameand Title Status 

### OWN OWN OWN OWN OWN OWN OWN OWN OWN
PAY

Heather R. Bjornson, RegulatoryConsultant Agency Internal Use Copy Page 2 of2

Note

0

...

Date

May21,2010, .,'ft i '*'" 

### , 

## , Form Approved aviS No, 207()'OO60
, UNITED STATES ENVIRONMENTAL PROTECTION AGENCY ,

, , , 401 M 

### Street, S.W. , ,
, , , ,

, ' " , WASHINGTON, D,C, 20460 Paperwork Reduction Act Notice: The Public reporting burden ror this collection ofinformation is estimated to average 0.25 hoursper response for registration**act~/::j3:;** aMc :l.25 hJ-"fS per response or reregistration and special reviewactivities, including time 

### or reading the instructions and compleling the necessaryforms. Send comments regarding the burden**or~o~oth&** 

### asreCt of :his collection of information, including suggestions br reducing the burden to: Director, CPP Information Management Division (2137)U.S. Envionmenta! Protection Agency, 401 M gtreet,**~.w.,** W3s:hll:'gton, DC 20460. Do not send the form to this address.**~ ~**  - -'**~** DATA MATRIX Date May 21, 2010 EPA Reg. No.fFile Symbol Page 1 of2 87650-R '_.' Applicant's/Registrant Name and Address Product Fipronext Solul'lons, Inc. 3259 Harvey Court Fipronil Technical Pleasanton, CA 94588 Ingredient Fipronil Guideline Reference Number GuideJJne Study Name MR!D Number Submitter Status Note Fipronext Solutions, Inc. 

### OWN Fipronext Solutions, Inc. 

### OWN Fipronext Solutions, Inc. 

### OWN Fipronext Solutions, Inc. 

### OWN Fipronext Solutions, Inc. 

### OWN



# - Fipronext Solulions, Inc. 

### OWN

Fipronext Solutions, Inc. 

### OWN Fipronext Solutions, !nc_ 

### OWN Fipronext Solutions. Inc. 

### OWN Fipronext Solujions, Inc. 

### OWN Fipronext Solutions, Inc. 

### OWN Signature

# ~K,r.?r-- Name and Title Date Heather R. Siornson,**~gulatory** Consultant May 21, 2010 EPA Form 8570-35 (9-97) Elec!ronic and Paper versions ayailable. Submit onlyPaper version Agency !n!ernal Use Copy/.-'

. ft

>i? Form Approved Oi\I1B No, 207().OO60 UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 401 M Street, S.W. WASHINGTON, D.C. 20460 

## .

Paperwork Reduction Act Notice: The Public reporting burden lOr this collection ofinformation is estimated to average 0.25 hours per response fir registration**activit~es_a!,d** 9.?5**hOUl:~_.per** response or reregistration and speciat review activities, including time br reading the instructions and compteting the necessaryforms. Send comments regarding the burden or an:,'**~ther** ",spe'it**(~f** thi::; collection of information, including suggestions br reducing the burden to: OJ-ector, OPP Information Management Division (2137)U.S. Environmental Protection Agency401 M Street;**S.It~~,_,Wasl,id!:Jt<)O,** DC 20460. Do not send the form to this address.
- "

Date May 21, 2010 Applicant'slRegistrant Name and Address Fipronext Solutions, Inc. 3259 HarveyCourt Pteasanton, CA 94588 tngredient Fipronll Guideline Reference Number Guideline Study Name

### Signat~iZ 

# 0JA

ICOll ICn_ 0""(\"" In n7\ 1C1

__,. __;n**~_** ... n __**~.** u_, :lro 'ape; 'sions available. Submit onlyPaperversionDATA MATRIX

MRtO Number EPA Reg. No.lFile Symbol 87650-R Product Ffpronfl Technical

Submitter Fipronext Solutions, tnc. Fipronext Solutions, Inc. Fipronext Solutions, Inc. Fipronext Solutions, Inc. Fipronext Solutions, Inc. Flpronext Solutions, tnc. Fipronext Solutions, Inc. Fipronext Solutions, Inc. Flpronext Solutions, tnc.
See attached data submitter's list

Name and Title Status 

### OWN OWN OWN OWN OWN OWN OWN OWN OWN
PAY

Heather R. Bjornson, RegulatoryConsullant Agency tnternal Use Copy Page 2 of2

Note

Date

May21,2010 

# -**',~,-**



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# --**~lIDOOlID~~O®Oill~ [l1)~rn** **lIDOO~\'7** FD.ESYMBOL

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# CONFIDENTIAL STATEMENT OF FORMULA ENCLOSED

DATE SUBMITTED

# ~tfl/1)

.

.

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.

.

.... ,••• m,.,____ , 

### SUBMITTED BY (.-) APPLICANT BASteSuPPuER

.

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# Do 

# Not Write Comments, Formula, or 

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# Formula on This 

# Envelope



# NOTE It sball be unlawfuJ-for any person 

### to use for hIs 

### own adVantage or 

### to reveal. other than

### to the SecretafJ. 0; offtdals or employees of the UnitedStates Department

### Oof AgrIcultUre or other Federalagencies., or 

### to the coarts In response 

### to a subpoena, or

### to physicians. and 

### In emergencies 

### to pharmacists and other qualified persons, for use In the preparation of antidotes, In accordance wttII such directions as the 

### Secretary may presCribe,,,any information relative 

### to formulas of 

### proCtucbl acquired bY authorityofSection 4,ofthe -FederallnsectJdde. FUngicide, and Rodetrtldde Act."-